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News In Research With Human Subjects for 2003 through 2005 (Articles are listed most recent first.)
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Week of December 26, 2005
Editorial Retraction: Jung and Hyun, Oocyte and somatic cell procurement for stem cell research: The South Korean experience, American Journal of Bioethics 6: W19-W22, January/February 2006
Patient-Centered Informed Consent in Surgical Practice, Bernat and Peterson, Archives of Surgery 141:86-92, January 2006 (abstract freely available)
Informing research participants of research results: analysis of Canadian university based research ethics board policies, MacNeil and Fernandez, Journal of Medical Ethics 32: 49-54, Jan 1, 2006 (abstract freely available)
Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya, Shaffer et al., Journal of Medical Ethics 32: 55-60, Jan 1, 2006 (abstract freely available)
Brief report on the experience of using proxy consent for incapacitated adults, Mason et al., Journal of Medical Ethics 32: 61-62, Jan 1, 2005 (abstract freely available)
The Ethics of Industry Experimentation Using Employees: The Case of Taste-Testing Pesticide-Treated Tobacco, McDaniel et al. American Journal of Public Health 96: 37-46, Jan 1, 2006 (abstract freely available)
Faster probe sought into research trials, Seattle Times, Dec 31, 2005
"The chairman of the Senate committee that oversees the Securities and Exchange Commission is prodding the agency to accelerate its investigation into the trafficking of clinical research trials information between doctors and Wall Street…"
Establishment and Operation of Clinical Trial Data Monitoring Committees, US FDA Center for Biologics Evaluation and Research, Dec 30, 2005
"This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs))…This guidance finalizes the draft guidance entitled "Guidance for Clinical Trial Sponsors: On the Establishment and Operation of Clinical Trial Data Monitoring Committees" dated November 2001…"
S. Korean School Debunks Hwang's Research, The San Francisco Chronicle, Dec 29, 2005
"South Korea's top university said Thursday that a leading researcher fabricated all of the stem cells he said were cloned from individual patients — a shattering blow to the disgraced scientist's reputation as a medical pioneer…"
Drug-trial registry data grows, but report faults some firms, Boston Globe, Dec 29, 2005
"Drug companies are making public more information about medical studies they are conducting, but some still withhold key details, a new analysis of a federal registry finds…"
Trial Registration at between May and October 2005, Zarin et al., New England Journal of Medicine 353, Dec 29, 2005 (full text freely available)
Trial Registration at between May and October 2005, Zarin et al., New England Journal of Medicine 353, Dec 29, 2005 (full text freely available)
Editorial: Trial Registration Report Card, Drazen and Wood, New England Journal of Medicine 353, Dec 29, 2005 (full text freely available)
Editorial: Registries and Registration of Clinical Trials, Haug et al., New England Journal of Medicine 353, Dec 29, 2005 (full text freely available)
Week of December 19, 2005
AIDS whistleblower reinstated, Monterey County Herald, Dec 24, 2005
"Reversing course, the government's premier health research agency has reinstated a medical safety expert who was fired after raising allegations of scientific misconduct and sexual harassment in federal AIDS research, his lawyer said Friday…"
South Korean researcher resigns after university says he faked stem cell research, San Diego Union Tribune, Dec 23, 2005
"South Korean researcher Hwang Woo-suk resigned from his university on Friday after the school said he fabricated stem-cell research that had raised hopes of new cures for hard-to-treat diseases…"
US research 'endangered Amazon villagers', The Guardian UK, Dec 20, 2005
"Health officials in Brazil have launched an investigation after claims that at least 10 impoverished Brazilians from an Amazon village may have contracted malaria while being used as human "guinea pigs" during a study by an American university…"
Week of December 12, 2005
Indy drivers aid military with crash research, MSNBC, Dec 17, 2005
"…Embedded inside was a tiny device used to detect and quantify the forces that pummel drivers during crashes. Air Force scientists are collecting the data to develop safer helmets, harnesses and ejection seats for military pilots…"
South Korean stands by his stem cell research, Seattle Times, Dec 16, 2005
"…Hwang Woo-suk apologized for "fatal errors and loopholes in reporting the scientific accomplishment" and said he has asked that the scientific article outlining his research be withdrawn…"
SFBC refutes magazine charges, Miami Herald, Dec 15, 2005
"In a 19-page letter to a U.S. senator scheduled to be released today, two outside counsels hired by SFBC International, the Miami drug-testing company, disputed much of the information in a recent negative magazine article, but said one executive's behavior was ''inappropriate'' in threatening test subjects who talked to reporters. The letter also recommends Congress adapt a database of persons who volunteer for drug tests so that subjects can't jump from one drug test to another without the testing companies knowing…"
Report to Senator Grassley from Independent Counsel to the Board of Directors of SFBC International Inc, Concerning Allegations Related to SFBC In Bloomberg’s Nov 2, 2005 Article, SFBC International Web Site, Dec 12, 2005 (no longer available)
SFBC Drug Testers Have Tuberculosis After Exposure at Center, Bloomberg, Dec 15, 2005
"…SFBC, which runs the largest clinical trial site in North America, kept Mohsen and his roommate together for another four days, says SFBC lawyer Michael York. In November, Mohsen learned that his roommate had active tuberculosis, and that Mohsen himself had contracted latent tuberculosis. Eight other participants in the September SFBC drug trial also tested positive for latent tuberculosis, according to the Montreal Regional Health Department…"
Researcher tries to distance himself from cloning work, Seattle Times, Dec 14, 2005
"Some of stem-cell researcher Hwang Woo-suk's high-profile human cloning work announced earlier this year may have been "fabricated," a former top collaborator charged as he attempted to distance himself from the groundbreaking research…"
Spanish Web Page, Office for Human Research Protections(OHRP) Web Site, Dec 13, 2005
The Office for Human Research Protections has recently launched its new Spanish web page. The Spanish web page includes:
  • 45 CFR 46, subparts A, B, C, and D
  • Step-by-Step Instructions to Register an IRB
  • Instructions for IRB Updates
  • Terms of the Federalwide Assurance (FWA)
  • Step-by-Step Instructions for an FWA application
  • Instructions for FWA Updates
Fraud earns researcher time in jail, The Scientist, Dec 13, 2005
"A Veterans Administration researcher based in New York was sentenced to almost 6 years in jail after he admitted to doctoring patient test results – an extreme punishment for an extreme crime, experts say…"
Human brain cells working in mice, The Seattle Times, Dec 13, 2005
"By injecting human embryonic stem cells into the brains of fetal mice inside the womb, scientists in California have created living mice with working human brain cells…Reflecting growing concerns about the ethics of making animal-human hybrids, the National Academy of Sciences earlier this year released voluntary guidelines on chimera research that have been adopted by major research institutes and have been made mandatory in California for state grant recipients…"
Guidelines for Human Embryonic Stem Cell Research, Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council, April 26, 2005 (full report freely available)
When researchers are the guinea pigs. Should scientists be allowed to continue studying themselves?, Boston Globe, Dec 12, 2005
"…Self-experimentation, though controversial, is a tradition that dates back centuries… But the ethical issues surrounding such research remain unresolved…"
Week of December 5, 2005
Behavioral and Social Issues Among Volunteers in a Preventive HIV Vaccine Trial in Thailand, Jenkins et al., Journal of Acquired Immune Deficiency Syndromes 40, Dec 15, 2005 (abstract freely available)
Assessing the Attitudes, Knowledge, and Awareness of HIV Vaccine Research Among Adults in the United States, Allen et al., Journal of Acquired Immune Deficiency Syndromes 40, Dec 15, 2005 (abstract freely available)
Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early, Mills et al. British Medical Journal 331: 1403-1406, Dec 10, 2005 (abstract freely available)
Payment to healthcare professionals for patient recruitment to trials: a systematic review, Bryant and Powell, British Medical Journal 331: 1377-1378, Dec 10, 2005 (abstract freely available)
Journal: Bad Vioxx outcomes not disclosed, Boston Globe, Dec 8, 2005
"Authors of a study funded by Vioxx maker Merck & Co. failed to disclose in a report published in the New England Journal of Medicine in 2000 that three additional patients in a clinical study suffered heart attacks while using the now-withdrawn painkiller, the journal wrote in an editorial released Thursday…"
Editorial: Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N Engl J Med 2000;343:1520-8, Curfman et al., New England Journal of Medicine, early publication, Dec 8, 2005 (scheduled to be freely available until Dec 29, 2005)
Press Release: Human Research Protection Award Recipients Announced, Dec 8, 2005
"Winners of the 2005 Award for Excellence in Human Research Protection were announced today by Dr. Peter G. Goldschmidt, President and Founder of the Health Improvement Institute…"
Study Debunks That Blacks Are Wary of Medical Research, Washington Post, Dec 6, 2005 (free one time registration required)
"…Given the chance to participate, minorities volunteer at least as often as whites do, according to the first study to measure response rates directly. And although minorities are indeed underrepresented in research, the reason appears to be that doctors and scientists reach out to them less…"
Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?, Wendler et al. Public Library of Science (PLoS) Medicine 3, published online Dec 6, 2005
Ethical concerns on face transplant grow, New York Times, Dec 6, 2005 (scheduled to be freely available until Dec 12, 2005, still available)
"In urgent telephone calls and agonized e-mail messages, American scientists are expressing increasing concerns that the world's first partial face transplant, performed in northern France on Nov. 27, may have been undertaken without adequate medical and ethical preparation…"
Oocyte and Somatic Cell Procurement for Stem Cell Research, Kyu Won Jung and Insoo Hyun, American Journal of Bioethics 5, Nov/Dec 2005 (full article freely available)
A Commentary on Oocyte Donation for Stem Cell Research in South Korea, Magnus and Cho, American Journal of Bioethics 5, Nov/Dec 2005 (full article freely available)
Week of November 28, 2005
All Multiple Project Assurances (MPA) and Cooperative Project Assurances (CPA) with the Department of Health and Human Services Expire December 31, 2005, OHRP News, OHRP Web Site, Dec 2, 2005
"…Since February 10, 2005, the FWA is the only type of assurance accepted for review and approval by OHRP. Institutions still holding a Multiple Project Assurance (MPA) or a Cooperative Project Assurance (CPA) have until December 31, 2005, to convert to the FWA if an OHRP-approved assurance of compliance is still required. Single Project Assurances (SPA) currently approved by OHRP will remain in effect for the duration of the project and through all non-competitive award renewals. To date, 96% (510) of the institutions holding an OHRP-approved MPA have converted to the FWA. However, only 58% (1,177) of the institutions holding an OHRP-approved CPA have converted to the FWA…On January 1, 2006, any institution that has not obtained an OHRP -approved FWA will no longer be covered by an OHRP -approved assurance of compliance, and therefore, any ongoing HHS-supported human subjects research at such an institution that is not exempt will need to be suspended until the institution submits, and OHRP approves, an FWA"
Amid concerns of quality, ethics, biotech firm answers China's call, Pioneer Press, Dec 2, 2005
"…Excorp joins growing numbers of medical companies heading to emerging countries such as China and India, either to reach large new patient markets or to cut costs on notoriously expensive, lengthy clinical trials for their products — or both, as in Excorp's case. It's a shift that's raising concerns among medical ethicists as well as some drug-development professionals who worry about whether emerging countries can meet U.S. standards for human testing. There are no international regulations for running human clinical trials, only guidelines…"
Children’s understanding of the risks and benefits associated with research, Burke et al. Journal of Medical Ethics 31: 715-720, Dec 1, 2005 (abstract freely available)
Parental preferences for neonatal resuscitation research consent: a pilot study, Culbert and Davis, Journal of Medical Ethics 31: 721-726, Dec 1, 2005 (abstract freely available)
Informed consent and participant perceptions of influenza vaccine trials in South Africa, Moodley et al., Journal of Medical Ethics 31: 727-732, Dec 1, 2005 (abstract freely available)
Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information, Lyn÷e and Hoeyer, Journal of Medical Ethics 31: 736-738, Dec 1, 2005 (abstract freely available)
The ethics of research using electronic mail discussion groups, Kralik et al., Journal of Advanced Nursing 52: p. 537, December 1, 2005 (abstract freely available)
Partial Face Transplant Done in France, The San Francisco Chronicle, Nov 30, 2005
"Doctors in France said they had performed the world's first partial face transplant, forging into a risky medical frontier with their operation on a woman disfigured by a dog bite…"
Week of November 21, 2005
Cloning master apologizes, quits, Seattle Times, Nov 25, 2005
"Hwang Woo-suk, a stem-cell pioneer whose South Korean team cloned the first human embryo and created the first cloned dog, publicly apologized Thursday for ethical breaches at his lab and said he would resign from all his official posts…"
HHS weighs relaxing restrictions on inmate testing,, Nov 23, 2005
"Officials at the Department of Health and Human Services are considering whether to loosen federal patient protections for prisoners, in order to allow more inmates to volunteer for medical experiments and social-science research…"
Ethical Considerations for Revisions to the DHHS Regulations for Protection of Prisoners Involved in Research, Institute of Medicine Project Web Page
S. Korean Stem Cell Team Paid Women for Eggs, Washington Post, Nov 22, 2005 (free one time registration required)
"The head of a Seoul fertility clinic associated with an embattled Korean stem cell researcher said yesterday that he paid 16 women for their eggs, according to a South Korean newspaper report…"
Ex-VA Researcher Sentenced in Drug Scandal, Seattle Post-Intelligencer, Nov 21, 2005 (no longer available)
"A former cancer researcher at a Veterans Affairs hospital was sentenced Monday to nearly six years in prison for criminally negligent homicide in the death of an Air Force veteran enrolled in a drug experiment…"
Harvard hopes database will speed cancer cures, The Boston Globe, Nov 21, 2005
"…Now the Harvard hospitals are establishing a "virtual specimen locator" to encourage sharing among researchers and speed up discovery of life-saving cancer screening tests and treatments -- a concept they hope to expand to the University of California, Los Angeles, the University of Pittsburgh, and the University of Indiana School of Medicine…The project faces a number of ethical and legal hurdles because the hospitals must develop ways to protect patients' identities, as information about them and their tumors rockets around the country via the Internet…"
Week of November 14, 2005
Three drug testers claim SFBC threatened them, Seattle Times, Nov 20, 2005
"SFBC International, which runs the largest private drug-test center in North America, threatened to arrange federal deportation of Latin American immigrants who disclosed health risks in clinical trials, according to people who participated in the company's Miami-based experiments…"
Women stay in bed for 60 days … for science, MSNBC, Nov 20, 2005
"…The joint study by the European Space Agency, the French space agency CNES, the Canadian Space Agency and NASA will fill in unknowns about how to protect women astronauts from the dramatic physical side effects of weightlessness…"
Secretary’s Advisory Committee on Human Research Protections (SACHRP) November 1 - 2, 2005 Meeting, Meeting Agenda, Presentation Materials and Meeting Transcripts, Office for Human Research Protections (OHRP) Web Site, posted Nov 18, 2005
Pediatric Obesity Devices Should Be Tested First In Children With Serious Co-Morbidities, Cmte. Says,, Nov 18, 2005
"Children initially enrolled in trials for devices that treat obesity should have a serious co-morbidity, members of FDA’s Pediatric Advisory Committee concurred…"
After The Disaster, Research Booms, CBS News, Nov 18, 2005
"…quick on the heels of relief workers come the disaster researchers - people who leave the ivory tower of academia and head to the scene, hoping their analyses can improve people's lives the next time calamity strikes…"
Lives that depend on studies in labs, The Hindu, India, Nov 16, 2005
"…While free medicine, medical attention and the promise of better health are luring several ailing persons to clinical trials, the offer of money is luring more healthy persons to volunteer for bio-equivalence studies, where clinical research organisations (CRO) evaluate the standard of the generic drug against the patented drug…"
'Stem cell hub' cloning network project folding. U.S. organizer cites 'misrepresentations' by plan's collaborators in South Korea, The San Francisco Chronicle, Nov 15, 2005
"A global consortium designed to pursue a controversial type of stem cell research involving cloned embryos is collapsing amid ethical questions surrounding human egg donations in South Korea…"
Appropriate Pediatric Age For Obesity Device Trials Will Be Discussed By Cmte.,, Nov 15, 2005
"The appropriate age for children enrolling in obesity device trials and their ability to assess the risk-benefit of the procedures will be among the questions discussed at the Nov. 16-17 meeting of FDA's Pediatric Advisory Committee…"
Chips spark ethics concerns, The Chattanooga Times Free Press, Nov 14, 2005 (no longer available)
"Medical ethics experts are questioning a proposal to implant medical identification microchips in the arms of developmentally disabled clients at Orange Grove Center…"
Week of November 7, 2005
Fighting For A Miracle, CBS News, Nov 13, 2005
"For many people with a terminal illness, their last hope may come from a drug that is not widely available…The only way to get such a drug is through a government approved clinical trial. But now some patients, their families and doctors say that clinical trials in terminally ill patients may be killing more people than saving…"
What do people at risk for Alzheimer disease think about surrogate consent for research? Kim et al. Neurology 65: 1395-1401, Nov 8, 2005 (abstract freely available)
Private tests a risky business, Seattle Times, Nov 7, 2005
"…The U.S. Food and Drug Administration has farmed out much of the oversight for protecting people in tests to private companies such as Western. WIRB monitors clinical trials for more than half the new drugs submitted each year to the FDA…"
Week of October 31, 2005
Human guinea pigs pay for lax FDA rules, Seattle Times, Nov 6, 2005
"…Across the U.S., 3.7 million people have enrolled in drug tests sponsored by the world's largest pharmaceutical companies…At the same time, the U.S. Food and Drug Administration has farmed out much of the responsibility for overseeing safety in these tests to private companies known as institutional review boards. These boards are also financed by pharmaceutical companies. So, the drug industry is paying the people who do the tests — and most of the people who regulate those tests…"
War hero died at clinic with history of neglect, Seattle Times, Nov 6, 2005
"…Polsgrove enrolled in a clinical trial for clozapine, a schizophrenia drug being tested for Ivax, the largest U.S. maker of generic drugs based in Miami…A day after he took the first dose, Polsgrove's heartbeat became irregular, according to a January 2005 letter to Fabre from the U.S. Food and Drug Administration…"
India plans to audit clinical trials, Mudur, British Medical Journal 331: 1004, Nov 5, 2005 (abstract freely available)
"The Indian government has announced a plan to set up a registry and to audit some clinical trials after being dogged for years by controversies over illegal and unethical trials…"
Review: Randomized Trials Stopped Early for Benefit: A Systematic Review, Montori et al., Journal of the American Medical Association 294:2203-2209, Nov 2, 2005 (abstract freely available)
Editorial: When (Not) to Stop a Clinical Trial for Benefit, Pocock, Journal of the American Medical Association 294: 2228-2230, Nov 2, 2005 (abstract freely available)
Study: Drug testing halted by early success doesn't help patients, USA Today, Nov 1, 2005
"There are many reasons to stop testing a promising new medical treatment early, but patients seldom benefit from the decision, a study reports today…"
Review: Randomized Trials Stopped Early for Benefit: A Systematic Review, Montori et al., Journal of the American Medical Association 294:2203-2209, Nov 2, 2005 (abstract freely available)
"Hello, hello—it’s English I speak!": a qualitative exploration of patients’ understanding of the science of clinical trials, Stead et al. Journal of Medical Ethics 31: 664-669, Nov 1, 2005 (abstract freely available)
How to handle informed consent in longitudinal studies when participants have a limited understanding of the study, Helgesson et al. Journal of Medical Ethics 31: 670-673, Nov 1, 2005 (abstract freely available)
Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information, Eriksson et al. Journal of Medical Ethics 31: 674-678, Nov 1, 2005 (abstract freely available)
Special Issue: The Ethical Conduct of Resuscitation Research, Proceedings of the 2005 AEM Consensus Conference, Academic Emergency Medicine 12, November 2005 (Table of Contents; abstracts and extracts freely available)
Hopeful patients crash S.Korea stem cell Web site, Reuters, Oct 31, 2005 (no longer available)
"…The stem cell bank began accepting on-line applications on Tuesday and its Web site ( and telephone lines have been stretched to their limits as patients and their families ask to be included in the research, bank officials said…"
American Association of Medical Colleges (AAMC) Adopts New Principles for Reporting Results of Clinical Trials, AAMC Web Site, Oct 31, 2005
"…The new principles are the product of a working conference convened by the AAMC in June…Participants were charged with drafting a set of comprehensive guidelines that would direct the ethical and operational aspects of data access, analysis, and reporting of clinical research studies. The principles aim to ensure that academic institutions not accept restrictions by sponsors that would exclude members of academic research teams from full intellectual participation in studies and thereby prevent those investigators from being held responsible and accountable for the results…"
Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials, American Association of Medical Colleges, Sept 15, 2005 (pdf file)
Week of October 24, 2005
Controversial Study Allows Parents to Pick Baby's Sex, ABC News, Oct 26, 2005
"Now, doctors at Houston's Baylor College of Medicine are conducting a "sex selection" study that will allow couples to make that wish come true — letting them actually pick their baby's gender…The whole idea of picking a baby's sex is so controversial, it took nine years for researchers to get permission to conduct the study…"
Commentary: The Declaration of Helsinki: an update on paragraph 30, Blackmer and Haddad, Canadian Medical Association Journal 173: 1052-1053, Oct 25, 2005 (full article freely available)
Effect of a Clinical Trial Alert System on Physician Participation in Trial Recruitment, Embi et al., Archives of Internal Medicine165:2272-2277, Oct 24, 2005 (abstract freely available)
Comment: Research and clinical ethics after the tsunami: Sri Lanka, Sumathipala and Siribaddana, Lancet 366:1418-1420, Oct 22, 2005 (free one time registration required; full text freely available)
Week of October 17, 2005
Patients turn guinea pigs minus cover, Calcutta Telegraph, India, Oct 23, 2005
"Neither government regulators nor ethics watchdogs in India have adequately equipped themselves to protect the interests of patients who volunteer for clinical trials of new and unproven treatment, clinical research experts have said… gaps in the skills of researchers and ethics committees have created the potential for exploitation of vulnerable sections of patients…"
Viewpoint: HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia, Page-Shafer et al., Lancet 366:1499-1503, Oct 22, 2005 (free one time registration required; full text freely available)
Study cites health risks of diabetes drug, Seattle Times, Oct 21, 2005
"A new diabetes drug on track to win approval from the Food and Drug Administration (FDA) more than doubles the risk of death, heart attack and stroke, a finding that renews concerns about the government's safety screening for new medications…"
Effect of Muraglitazar on Death and Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes Mellitus, Nissen et al. Journal of the American Medical Association Early Release, Oct 20, 2005 (abstract freely available)
Editorial: Selling Safety--Lessons From Muraglitazar, Brophy, Journal of the American Medical Association Early Release, Oct 20, 2005 (extract freely available)
Effects of Hurricanes Katrina and Rita on IRB Operations, Office for Human Research Protections, Oct 20, 2005
"OHRP understands that the effects of Hurricanes Katrina and Rita have been devastating to areas in Louisiana, Texas, Alabama and Mississippi, and as a result, some human subject protection programs at institutions in the affected areas are unable to function, and may be unable to for some time. OHRP has prepared information to help institutions and institutional review boards (IRBs) manage the hurricanes' impact on oversight of research and research subject interventions…"
Press Release: UNESCO’s General Conference adopts Universal Declaration on Bioethics and Human Rights, UNESCO Web Site, Oct 19, 2005
"…framework of principles and procedures that can guide Member States in the development of national policies, legislation and codes of ethics…"
Universal Declaration on Bioethics and Human Rights, UNESCO, Oct 19, 2005
Koreans plan to create 100s of stem cell lines, San Francisco Chronicle, Oct 19, 2005
"Several U.S. researchers already are lined up to participate… Some leading biomedical centers, including Stanford University and UCSF, were recruited to participate but so far have declined, citing reservations about the project's legal and bioethical framework…"
Perspective: An Offshore Haven for Human Embryonic Stem-Cell Research? Okie, New England Journal of Medicine 353:1645-1649, Oct 20, 2005 (extract freely available)
Week of October 10, 2005
A Second Chance at Survival, Wilkes Barre Times-Leader, Oct 16, 2005
"A patient turns to an experimental gene drug being tested at Penn to try to stop a deadly cancer…"
ESRC announces research ethics framework, ResearchResearch, UK, Oct 14, 2005
"The Economic and Social Research Council has announced a new research ethics framework for social sciences research, which will take effect from 1 January…"
Economic and Social Research Council Research Ethics Framework, October 2005 (pdf file)
Translational and Clinical Science — Time for a New Vision, Zerhouni, New England Journal of Medicine, 353:1621-1623, Oct 13, 2005 (full text freely available)
Audio interview with Dr. Elias Zerhouni (freely available, Macromedia Flash Player required)
OHRP Compliance Oversight Activities: Significant Findings and Concerns of Noncompliance, Division of Compliance Oversight, Office for Human Research Protections (OHRP ), Oct 12, 2005 (pdf file)
"This document provides a list of significant findings that OHRP has made and concerns that have been expressed in compliance oversight determination letters over the last several years…"
Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others, Office for Human Research Protections, Oct 11, 2005 (comments due by Jan 13, 2006)
"The Office for Human Research Protections (OHRP) is soliciting public comment on a draft guidance document for Institutional Review Boards, investigators, research institutions, Department of Health and Human Services agencies that conduct or sponsor human subjects research, and other interested parties…"
Draft Document: Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others, OHRP, Oct 11, 2005
Physicians want transparency as Guidant lawsuits grow, Canadian Medical Association Journal 173: 855-856, Oct 11, 2005
"…Guidant Canada's recall of several models of implantable cardiac defibrillators (ICDs), which was triggered by a front-page New York Times story saying the company had concealed problems with one model for 3 years…"
UW halts enrollment in study after regulators find problems, The Seattle Times, Oct 10, 2005
"The federal government has identified more safety problems with human research at the University of Washington, prompting the school to halt further enrollment in a genetic study…"
Week of October 3, 2005
When the Doctors Are Their Own Best Guinea Pigs, The New York Times, Oct 9, 2005 (archived, payment required)
"…How many other Dr. Marshalls are out there - scientists who become their own guinea pigs? No one knows because no one keeps tabs on the number of experiments performed on people in this country or elsewhere…"
S. African university slams "AIDS vitamins" doctor, Reuters, Oct 7, 2005 (no longer available)
"Johannesburg's University of the Witwatersrand (Wits) has demanded Dr Matthias Rath stop what it says are unethical trials of his multivitamins on AIDS sufferers in Cape Town's Khayelitsha township… South Africa's Medicines Control Council (MCC) is probing claims that the foundation is conducting illegal research trials on AIDS victims and that it is urging patients not to take ARVs…"
Ethics Of Leuprolide Test For Puberty Disorders To Be Reviewed By Subcommittee, FDA Advisory Committee, Oct 6, 2005
"A University of Chicago research protocol for a test using leuprolide (TAP’s Lupron) to detect puberty disorders will be reviewed by FDA’s Pediatric Ethics Subcommittee at its Nov. 15 meeting…"
Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders of Puberty. Docket No. 2005N-0404, [Pages 58713-58714 Federal Register Doc. 05-20301] (Comments due November 1, 2005)
Gonadotropin Releasing Hormone (GnRH) Agonist Test in Disorders of Puberty, Protocol, IRB Documents, Study Communications
FAQs on Research Involving Children, Office for Human Research Protections (OHRP) Web Site, Oct 3, 2005
"OHRP announces the availability of a new set of Frequently Asked Questions (FAQs), which help clarify issues related to research involving children…"
Week of September 26, 2005
International Compilation of Human Subject Research Protections, second edition, Office for Human Research Protections (OHRP), Oct 1, 2005 (pdf file)
"The Second Edition encompasses 72 countries, lists standards issued by international organizations, includes updated information for General and Drug research, and provides a listing of the laws, regulations, and guidelines on privacy/data protection, human biological materials, and genetic research. The Compilation now provides over 400 direct web links to each country's key organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable standards…"
Stroke patients' preferences and values about emergency research, Blixen and Agich, Journal of Medical Ethics 31: 608-611, Oct 1, 2005 (abstract freely available)
Vital research given go ahead by parents, Journal of Medical Ethics 31: 590, Oct 1, 2005 (extract freely available)
Cancer trials delayed by contraceptive objections, Sunday Business Post, Ireland, Oct 1, 2005 (no longer available)
"…questions were raised by a member of the ethics committee at St Vincent's Hospital, Dublin 4,who wanted the stipulation that female cancer patients undergoing clinical trials should use barrier contraceptives removed from the protocol, citing religious grounds…"
Human guinea pigs queue for cash as drug firms rush to India, TODAYonline, Singapore, Sept 30, 2005
"…Critics say India's huge illiterate population is in danger of being misused by unethical firms to test suspect drugs. But industry officials say each trial follows a strict code of ethics…"
Senators Seek FDA Chief Resignation Probe, The San Francisco Chronicle, Sept 29, 2005
"Senators with oversight of the Food and Drug Administration asked for an inspector general's inquiry Thursday into the circumstances surrounding the sudden resignation of the agency's chief…"
Office of Research Integrity (ORI) 2005 Extramural Award Data, ORI Web Site, Sept 28, 2005 (links to all project abstracts)
"Seven awards were made by the Research on Research Integrity (RRI) Program in response to 47 applications received…"
Bioethics 'expertise' comes from all corners, USA Today, Sept 28, 2005
"Any given Sunday morning, a bioethicist somewhere in America suits up for a TV appearance…But who are these people opining on what we should do?…"
Draft Revision of 1991 Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Ethical Review of Epidemiological Studies, Council for International Organizations of Medical Sciences (CIOMS) Web Site, Sept 28, 2005 (pdf file, comments due end of October 2005)
CIOMS Web Site Home Page
Week of September 19, 2005
FDA commissioner abruptly steps down, Seattle Times, Sept 24, 2005
"Food and Drug Administration (FDA) Commissioner Lester Crawford resigned unexpectedly yesterday, two months after he survived a tough Senate confirmation…"
Parents gamble on unproven therapy to give daughter a normal life, Myrtle Beach Sun News, Sept 23, 2005
"Last week, little Ariel Coover lay with her chin tucked to her chest in a bright, white operating room at Cooper University Hospital in Camden, N.J. The only visible part of the 3 1/2-month-old was the top of her bald head, where six catheters protruded like shiny strands of hair…Ariel is the latest and youngest patient in the first clinical gene-transfer study…"
Possible Conflicts for Doctors Are Seen on Medical Devices, Wilmington Morning Star, Sept 22, 2005 (no longer available)
"…in a variety of ways, many doctors have unusually close, if largely unseen, ties to device makers. And those relationships are a central issue on an emerging battleground in the health care wars: the upward cost spiral of implantable medical devices…"
Senate Eyes FDA Conflict of Interest Probe, The San Francisco Chronicle, Sept 21, 2005
"Senators asked Congress' investigative arm Wednesday to look into the Food and Drug Administration's practice of letting scientists serve on its advisory panels even if they have conflicts of interest…"
U.S. Senate votes for more information on FDA panels, Reuters, Sept 21, 2005 (no longer available)
"The Food and Drug Administration would have to disclose the industry ties of advisory committee members 15 days prior to their meetings under a measure passed by the U.S. Senate…"
Drug firms launch Web site to disclose trials data, Reuters, Sept 21, 2005 (no longer available)
"The global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines, in a bid to allay patient fears over drug safety…"
International Federation of Pharmaceutical Manufacturers and Associations Clinical Trials Portal (launched Sept 21, 2005)
Journal of the American Medical Association Special Issue: Medical Research - State of the Science, JAMA 294, pp. 1307-E8, Sept 21, 2005 (table of contents and abstracts/extracts/full text freely available)
Selected articles include:
Financial Anatomy of Biomedical Research, Moses et al. JAMA 294:1333-1342, Sept 21, 2005 (abstract freely available)
US Biomedical Research: Basic, Translational, and Clinical Sciences, Zerhouni, JAMA 294:1352-1358, Sept 21, 2005 (abstract freely available)
Prospects for the Future of Child Health Through Research, Feigin, JAMA 294:1373-1379, Sept 21, 2005 (abstract freely available)
Public Attitudes and Perceptions About Health-Related Research, Woolley and Propst, JAMA 294:1380-1384, Sept 21, 2005 (abstract freely available)
Consensus and Controversy in Clinical Research Ethics, Brody et al., JAMA 294:1411-1414, Sept 21, 2005
Guidance on Institutional Review Board (IRB) Review of Clinical Trial Websites, Office for Human Research Protections (OHRP) Web Site, Sept 20, 2005
"The guidance, which applies to HHS-conducted or -supported research, describes the circumstances for which IRB review of clinical trial websites is required and provides some points to consider in the review process. It also describes the circumstances for which IRB review of clinical trial websites is not required…"
Requests for Public Comment, OHRP Website, Sept 20, 2005
"OHRP has added a "Requests for Public Comment" section to its website. Simultaneously with the addition of the new website section, OHRP invites public comments on the following…"
OHRP's August 31, 2005 Letter to the National Cancer Institute (NCI) on Conflicting Interest and the Pediatric Central IRB (PedCIRB) (comments due by Dec 15, 2005)
Study: Medical Research Spending Jumps, The San Francisco Chronicle, Sept 20, 2005
"Total U.S. spending on medical research has doubled in the past decade to nearly $95 billion a year, though whether the money is being well spent needs much better scrutiny, a study has found…"
Financial Anatomy of Biomedical Research, Moses et al. JAMA 294:1333-1342, Sept 21, 2005 (full text freely available)
Journal of the American Medical Association Special Issue: Medical Research - State of the Science, JAMA 294, pp. 1307-E8, Sept 21, 2005 (table of contents and abstracts/extracts/full text freely available)
Report: Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, Board on Children, Youth and Families (BCYF) of the National Research Council and the Institute of Medicine, Sept 19, 2005
"In the wake of the Maryland Court of Appeals ruling in the case of Grimes v. Kennedy Krieger Institute, the National Academies was asked to review the challenges and ethical issues in conducting housing-related health hazards research…"
Executive Summary (33 pages, pdf file)
Week of September 12, 2005
Dozen to Interview for Chance at New Face, The San Francisco Chronicle, Sept 18, 2005
"In the next few weeks, five men and seven women will secretly visit the Cleveland Clinic to interview for the chance to have a radical operation that's never been tried anywhere in the world… The "consent form" says that this surgery is so novel and its risks so unknown that doctors don't think informed consent is even possible. Here is what it tells potential patients…"
Editorial: Reforming research ethics committees, Ashcroft et al. British Medical Journal 331:587-588, Sept 17, 2005 (extract freely available)
Secretary’s Advisory Committee on Human Research Protections (SACHRP) Agenda and Meeting Materials from Aug 1-2, 2005 Meeting, OHRP Web Site, Sept 16, 2005
Wall Street and Clinical Trials, Steinbrook, New England Journal of Medicine 353:1091-1093, Sept 15, 2005 (extract freely available)
Week of September 5, 2005
Panel Backs Drug Amid Conflict Concerns, New York Times, Sept 10, 2005 (free one-time registration required; archived, payment required)
"Questions about potential conflicts of interest continue to dog the federal drug approval process. A Food and Drug Administration advisory panel in Silver Spring, Md., recommended approval yesterday of the Bristol-Myers Squibb diabetes drug, Pargluva…But no cardiologist was present for the vote…"
Open label extension studies: research or marketing?, Taylor and Wainwright, British Medical Journal 331:572-574, Sept 10, 2005 (extract freely available)
Congress investigating Gates Foundation exec, Seattle Times, Sep 9, 2005
"The director of the Gates Foundation's multibillion-dollar global health program, Dr. Richard D. Klausner, is at the center of a congressional investigation into practices within a government agency he once directed…"
Gates Foundation exec quits; says move not tied to federal investigation, Seattle Times, Sept 13, 2005
Bioethics Council Head to Step Down, Washington Post, Sept 9, 2005 (free one-time registration required)
"Leon R. Kass, the University of Chicago medical ethicist who four years ago today was named by President Bush to head the newly created President's Council on Bioethics, will step down as chairman Oct. 1, the White House announced late Wednesday…"
Ban sought on pesticide tests of children, mothers to be, Seattle Times, Sep 8, 2005
"The Environmental Protection Agency yesterday proposed banning pesticide testing on pregnant women and children. The move followed criticism that the government's reliance on human pesticide tests has irresponsibly endangered vulnerable people…Critics, however, said the proposed regulation, the agency's first aimed at human pesticide testing conducted with or without government funding, contains too many loopholes…"
Protection for Human Subjects, proposed rule, EPA Web Site, Sept 7, 2005 (90 day public comment period)
FDA Standards — Good Enough for Government Work?, Avorn, New England Journal of Medicine 353: 969-972, Sept 8, 2005 (full text freely available)
Audio interview with Dr. Jerry Avorn (freely available, Macromedia Flash Player required)
Regulating Academic–Industrial Research Relationships — Solving Problems or Stifling Progress? T.P. Stossel, New England Journal of Medicine 353:1060-1065, Sept 8, 2005 (extract freely available)
Medical Students’ Exposure to and Attitudes About Drug Company Interactions: A National Survey, Sierles et al. Journal of the American Medical Association 294:1034-1042, September 7, 2005 (abstract freely available)
UNESCO guidance on ethics and human rights slammed,, Sep 6, 2005
"A recent UNESCO declaration on ethical and human rights aspects of medical research has been heavily criticised by an international group of specialists in the field, who say it has little value…"
Universal Draft Declaration on Bioethics and Human Rights, UNESCO, June 24, 2005 (pdf file)
Developing World Bioethics Special Theme Issue, September 2005 (article abstracts freely available)
Week of August 29, 2005
Paying research participants: a study of current practices in Australia, Fry et al. Journal of Medical Ethics 31: 542-547, Sept 1, 2005 (abstract freely available)
Controversial choice of a control intervention in a trial of ventilator therapy in ARDS: standard of care arguments in a randomised controlled trial, Mann, Journal of Medical Ethics 31: 548-553, Sept 1, 2005 (abstract freely available)
Joint Commission and NCQA to Discontinue Partnership for Human Research Protection, Inc., PHRP Web Site, Aug 31, 2005
"The Joint Commission on Accreditation of Healthcare Organizations and National Committee for Quality Assurance (NCQA) today announced that they have jointly decided to dissolve the Partnership for Human Research Protection, Inc. (PHRP), effective November 15, 2005…"
Cycling group to investigate Armstrong report, Grand Forks Herald, Aug 29, 2005
"…The World Anti-Doping Agency code on research says samples should never be identified. Also, samples cannot be used for research unless they have the athlete's consent…"If they are going to do some kind of research five or 10 years from now, that's fine because I have nothing to hide," Vandevelde said by phone Friday, a day before starting the Vuelta de Espana. But he also pondered the ramifications of such a practice: "Am I doing a drug test or am I a guinea pig?"…"
Week of August 22, 2005
NIH eases ethics rules, The Scientist, Aug 26, 2005
"The National Institutes of Health (NIH) will ease previously issued ethics rules, the agency announced yesterday (August 25)…"
NIH Announces Final Ethics Rules. Ban on Outside Consulting with Industry Remains in Force, NIH News, Aug 25, 2005
Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services, Aug 25, 2005 (pdf file)
Summary of Regulation, NIH Conflict of Interest Web Page, August 25, 2005
Questions and Answers for Employees, NIH Conflict of Interest Web Page, August 25, 2005
Draft Guidance for Industry on Gene Therapy Clinical Trials-Observing Participants for Delayed Adverse Events, Federal Register 70: pp. 49296-49297, FDA Docket No. 2005D-0310, Aug 23, 2005 (comments due Nov 21, 2005)
"…This draft guidance provides to sponsors of gene therapy studies recommendations on: (1) Methods to assess the risk of gene-therapy-related delayed adverse events following exposure to gene therapy products, (2) guidance for determining the likelihood that long-term followup observations on study participants will provide scientifically meaningful information, and (3) specific advice regarding the duration and design of long-term followup observations…"
The Draft Guidance (pdf file)
New Federal Requirements for Investigating and Managing Allegations of Research Misconduct, Mondaq News Alerts, Aug 23, 2005 (free one-time registration required)
"On June 16, 2005, the Public Health Services’ (PHS) final rule on research misconduct, first published on May 1, 2005, went into effect (the June 2005 rule)…"
Final Rule: Public Health Service Policies on Research Misconduct – 42 CFR Part 93 – June 16, 2005 (HTML version)
Final Rule: Public Health Service Policies on Research Misconduct – 42 CFR Part 93 – June 16, 2005 (pdf version)
Requirements for Institutional Policies and Procedures on Research Misconduct Under the New PHS Policies on Research Misconduct, 42 CFR Part 93, Office of Research Integrity (ORI) Web Site
Questions and Answers - 42 CFR Part 93, Office of Research Integrity (ORI) Web Site
Presentation and subsequent publication rates of phase I oncology clinical trials, Camacho et al. Cancer, published online Aug 22, 2005, print Oct 1, 2005 (abstract freely available)
Medical Studies and the Average American Kid, Washington Post, Aug 22, 2005 (free one-time registration required)
"…As it turns out, the day-to-day risks of being a kid are considerably higher than many people appreciate, these experts assert. And therein, they conclude, lies a problem with federal rules on research involving children. By assuring that risks will be no more than "routine," they convey a false ring of security…"
Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research Without a Prospect of Direct Benefit, Wendler et al. Journal of the American Medical Association 294:826-832, Aug 17, 2005 (abstract freely available)
New advance has potential to alter stem-cell debate, Seattle Times, Aug 22, 2005
"For the first time, scientists have turned ordinary skin cells into what appear to be embryonic stem cells — without having to use human eggs or make new human embryos in the process, as has previously been required, a Harvard research team announced yesterday…if further studies confirm its usefulness, it could offer an end run around the heated social and religious debate that has overshadowed the field of human embryonic stem-cell research…"
Week of August 15, 2005
Med schools urged to plug drug-research leaks, Seattle Times, Aug 19, 2005
"The Association of American Medical Colleges yesterday urged all of the nation's 125 accredited medical schools to tell their doctors to "scrupulously honor" confidentiality agreements for ongoing research…"
ICMR steps in to ensure ethics in clinical trials, Pune Newsline, Aug 18, 2005
"…concerned over the rights and safety of volunteers, the Indian Council of Medical Research (ICMR) has launched a first-of-its-kind national survey of over 1,000 scientific institutions and medical colleges to assess their “ethics committees”…"
Connected on Campus, Inside Higher Ed, Aug 17, 2005
"A newspaper’s investigation is focusing new attention on the way some university researchers take money to share early opinions about clinical drug trials they are conducting… Universities should consider adopting a blanket rule saying that researchers should not speak with investors, reporters, or anybody else about the trial, except to publicize that it is ongoing, until it is over, Pendergast said…"
Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research Without a Prospect of Direct Benefit, Wendler et al. Journal of the American Medical Association 294:826-832, Aug 17, 2005 (abstract freely available)
Medical-device industry having tribulations over trials, Wilkes Barre Times-Leader, Aug 16, 2005
"Clinical trials are the lifeblood of medical-device and drug firms…If the trial is delayed, companies must wait to sell their new therapies and patients must wait to benefit from them. The problem, especially for the medical-device industry, is only going to get worse. During the past decade, the Food and Drug Administration has been bringing up the standards of device trials to those set for drugs — a push reinforced by the trend to load drugs onto devices…"
Doctors' Links With Investor Matchmakers Raise Concerns, New York Times, Aug 16, 2005 (free one-time registration required; archived, payment required)
"…Nearly 10 percent of the nation's 700,000 doctors have signed up as consultants with a new segment of the investment industry - companies that act as the of the investment world, according to an article in The Journal of the American Medical Association. For a fee, they arrange conversations between investors and leading professionals, experts or even employees of major companies…"
Physicians and the investment industry, Topol and Blumenthal, Journal of the American Medical Association 293:2654-2657, June 1, 2005 (extract freely available)
The Right Stuff. Rigorous Herbal Study Proves Internet's Research Potential, Washington Post, Aug 16, 2005 (free one-time registration required)
"A new study affirms the feasibility of using the Internet to conduct gold-standard medical research. The authors say the findings are the first to be based on a randomized, placebo-controlled, double-blind clinical trial conducted entirely via the Internet…"
An Internet-Based Randomized, Placebo-Controlled Trial of Kava and Valerian for Anxiety and Insomnia, Jacobs et al. Medicine 84: 197-207, July 2005 (abstract freely available)
New ethical requirements at the NIH: implications for CIHR and Canada, Bernstein, Canadian Medical Association Journal 173, Aug 16, 2005
"…I wish to discuss this new US landscape and its possible implications for Canadian health research…"
UK consults on embryo law, The Scientist, Aug 16, 2005
"The British government today (August 16) launched a major consultation on the laws governing the technology and techniques used to assist human reproduction and embryo research…"
The Sociology of IRB’s, Inside Higher Ed, Aug 15, 2005
"For decades, but especially in recent years, social scientists have been frustrated by institutional review boards, campus bodies that must approve studies involving human subjects… To most sociologists, the fact that their projects face the same scrutiny as medical research makes little sense…"
Flaws are found in validating medical studies, Boston Globe, Aug 15, 2005
"Now, after a study that sent reverberations through the medical profession by finding that almost one-third of top research articles have been either contradicted or seriously questioned, some specialists are calling for radical changes in the system…"
Week of August 8, 2005
Playing It Safe With Research Risk, Chronicle of Higher Education, Aug 12, 2005
"…Here is a rundown of the research-safety panels that exist at most institutions, along with a brief description of what they do. This article is not meant to be a definitive review of the myriad regulations governing research safety. The intent is to alert you to situations where you might need to gain official approval before beginning your work, so that you can plan ahead instead of getting caught short…"
EPA Devises Rules on the Use of Data From Pesticide Tests on Humans, Washington Post, Aug 11, 2005 (free one-time registration required)
"The Environmental Protection Agency is set to release the first-ever federal standards governing use of data from tests that expose human subjects to toxic pesticides, but lawmakers and some medical experts said the rules fail to adequately protect children and pregnant women…"
Cameroon: FHI Ends Clinical Trial of ARV Drug Tenofovir,, Aug 10, 2005 (archived, paid subscription required to access archive)
"A US-based research organisation has announced that it will end the controversial testing of the anti-AIDS drug, Tenofovir, on sex workers in Cameroon…Clinical trials were suspended five months ago after health authorities questioned the manner in which the tests were being conducted…"
Regulators probe sale of secrets by doctors, Seattle Times, Aug 10, 2005
"The federal Securities and Exchange Commission is investigating the practice of doctors selling secrets about new drug research to Wall Street firms, SEC officials confirmed yesterday…"
Senator wants SEC to probe leaks of drug-research secrets, Seattle Times, Aug 8, 2005
Researchers leak secrets to Wall St, Seattle Times, Aug 7, 2005
Some doctors see ethical pitfall in actions that others defend, Seattle Times, Aug 7, 2005
Disclosing Individual Results of Clinical Research. Implications of Respect for Participants, Shalowitz and Miller, Journal of the American Medical Association 294:737-740, Aug 10, 2005 (extract freely available)
Special Report: Selling Drug Secrets, Project Home Page, Seattle Times, Aug 7, 2005
Press Release: Survey Uncovers Surprising Attitudes Towards HIV Vaccine Research, NIH News, Aug 8, 2005
"A survey of U.S. adults has found that a majority believe that HIV vaccines are the best hope for controlling the global AIDS epidemic and are confident such vaccines can be made. But while most of those surveyed felt it personally important to help support HIV vaccine research, a majority expressed reluctance to support a friend or family member’s participation in an HIV vaccine clinical trial…"
Week of August 1, 2005
Dorm spy. An anthropologist's undercover project raises ethical hackles, The Boston Globe, Aug 7, 2005
"…a fiftysomething anthropologist who enrolled under a pseudonym as a freshman at the university where she teaches is making news of her own… When does ethnography cross the line and become vaguely creepy spying on your students?…"
F.D.A. Responds to Criticism With New Caution, The New York Times, Aug 6, 2005 (free one time registration required; archived, payment required)
"…The agency is issuing twice the number of public advisories about drug risks as it did a year ago and adding five times as many black box warnings - its most serious alert - to drug labels. And drugs approved in the first half of this year took almost twice as long to get that approval as drugs approved in the same period last year…"
Report Identifies Lapses in NIH Monitoring, The San Francisco Chronicle, Aug 5, 2005
"An internal investigation has identified lapses in the way the National Institutes of Health monitors outside work by its scientists, including several cases in which employees took outside jobs before getting permission…"
Report: Outside Activities of Senior-Level NIH Employees, Office of the Inspector General, July 2005, released Aug 5, 2005 (pdf file)
Mental-health study slammed for using children, Swissinfo, Aug 5, 2005
"…The project, Swiss Etiological Study of Adjustment and Mental Health, is to recruit and examine a population sample of 3,000 children from early pregnancy to 20 years of age, along with their parents and grandparents. The aim of the multi-disciplinary study is to understand "the pre-disease pathways leading to the development of mental disorders and maladjustment"…"
45 CFR part 46, Office for Human Research Protections (OHRP) Web Site, Aug 4, 2005
"OHRP has posted a revised, up-to-date version of the HHS regulations for the protection of human subjects This updated version includes the following technical amendments that were announced in the FEDERAL REGISTER on June 23, 2005: Changing references to the "Office for Protection from Research Risks" to "Office for Human Research Protections, or any successor office"; Changing the Office of Management and Budget (OMB) control number for the Paperwork Reduction Act clearance from "9999-0020" to the current number "0990-0260"; Rewording the footnote to section 45 CFR 46.101(i) to reflect the 2001 change in Subpart B of 45 CFR part 46 that made the exemptions described in section 101(b) applicable to research covered by subpart B."
Little white lies could help in dieting, study finds, Seattle Times, Aug 2, 2005
"…A team led by psychologist Elizabeth Loftus of the University of California, Irvine, found that it could persuade people to avoid fattening foods by implanting unpleasant childhood memories about the food — even though the events never happened…Deliberately implanting memories also "raises profound ethical questions," said Stephen Behnke, director of the ethics office of the American Psychological Association…"
German ethics council under fire, The Scientist, Aug 1, 2005
"With German national elections looming, leading members of the main opposition parties have expressed deep dissatisfaction with the way that the country's National Ethics Council operates…[Weber-Hassemer] said that because of Germany's Nazi past, an ethics council representing the people was important to provide guidance on medical research in life sciences. "In Nazi Germany, scientists did horrible things," she said. "For Germans, research in medicine is much more complicated to discuss than it is in other countries."…"
A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials, Russell et al., Journal of Medical Ethics, 31: 490-494, Aug 1, 2005 (abstract freely available)
The reform of UK research ethics committees: throwing the baby out with the bath water? Kerrison and Pollock, Journal of Medical Ethics 31: 487-489, Aug 1, 2005 (abstract freely available)
Editorial: The Ad Hoc Advisory Group’s proposals for research ethics committees: a mixture of the timid, the revolutionary, and the bizarre, Dawson, Journal of Medical Ethics 31: 435-436, Aug 1, 2005 (extract freely available)
Week of July 25, 2005
Suspected research fraud: difficulties of getting at the truth, White, British Medical Journal 331: 281-288, July 30, 2005 (extract freely available)
Investigating the previous studies of a fraudulent author, Smith, British Medical Journal 331:288-291, July 30, 2005 (extract freely available)
An Anthropologist Goes Under Cover, Chronicle Review, July 29, 2005
"Three years ago, while a tenured professor on sabbatical, I conducted research by enrolling as a freshman in my own university…In the process, I learned a lot about not only higher education but also about ethical issues in research -- and how questions of disclosure can entail a host of unanticipated decisions about what are legitimate data to report and even how to write…"
Ethics of Clinical Trials, PBS, July 29, 2005
"Today we look at the ethics of clinical trials…"
Understanding Clinical Trials: Facts to Help Patients Make an Informed Decision, Patient Brochure published by the American Society for Therapeutic Radiology and Oncology (ASTRO), July 29, 2005
Understanding Clinical Trials (html)
Understanding Clinical Trials (pdf)
Congress Blocks EPA on Pesticide Testing, The San Francisco Chronicle, July 28, 2005
"Congress is blocking the Environmental Protection Agency from relying on tests that expose pregnant women, infants and children to pesticides when the agency considers permits for pest killers…"
Paramedics to test heart attack device without patient consent, Grand Forks Herald, Jul 27, 2005
"For a clinical trial, paramedics in St. Paul and Minneapolis will be testing experimental suction devices on heart attack patients without their prior consent. While informed consent is a staple of most medical research, exceptions are allowed when the consent impedes potentially lifesaving research that can't be completed any other way…"
A New Face: A Bold Surgeon, an Untried Surgery, New York Times, July 26, 2005 (free one-time registration required; archived, payment required)
"…A team led by Dr. Siemionow is planning to undertake what may be the most shocking medical procedure to occur in decades: a face transplant. After years of heated scientific debate over ethics and technical feasibility, the Cleveland Clinic last fall became the first institution to approve this novel surgery. Already Dr. Siemionow's group is searching for its first patient…"
Should kids be used in clinical research?, Seattle Post-Intelligencer, July 26, 2005 (scheduled to be freely available until Aug 1, 2005, still available)
"…At the core of the debate: When is it appropriate to put children at risk to test experimental drugs or devices? But do doctors and pharmaceutical companies also have an ethical obligation to conduct research that could help sick kids?…"
Week of July 18, 2005
Undue inducement in clinical research in developing countries: is it a worry?, Emanuel et al., Lancet 366: 336-340, July 23, 2005 (free one-time registration required; full article freely available)
Comment: Undue inducement in clinical research, Martin, Lancet 366: 275-276, July 23, 2005 (free one-time registration required; full article freely available)
Bioethics: Enduring pain to aid others, The Seattle Times, July 22, 2005
"Should parents be able to submit healthy children to painful or dangerous treatment? Should a child be able to say no? What about the risks of not doing research on children? …the Center for Pediatric Bioethics at Children's Hospital & Regional Medical Center [Seattle]…is the first in the country devoted to exploring the growing number of controversies in research and health care involving children…"
International Compilation of Human Subject Research Protections, Office for Human Research Protections, dated June 20, 2005 and posted online July 19, 2005 (pdf file)
"The Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections, listing the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted. The Compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable law…"
Essay: The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?, Singh and Mills, Public Library of Science Medicine (PLoS Medicine), July 19, 2005 (full article freely available)
Medical-device monitoring falls short, report says, Seattle Times, July 19, 2005
"Government regulators lack an effective system to monitor the safety of medical devices, which include items as diverse as incubators for premature babies, surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued yesterday…"
Safe Medical Devices for Children, Committee on Postmarket Surveillance of Pediatric Medical Devices, Institute of Medicine, July 18, 2005
FDA halts expansion of network to monitor medical device safety, The Boston Globe, July 14, 2005
Senate confirms new FDA chief, Seattle Times, July 19, 2005
"After waiting in limbo for months, Lester Crawford was confirmed by the Senate yesterday as commissioner of the Food and Drug Administration…"
Week of July 11, 2005
Clinical trials and errors, Fort Wayne Journal Gazette, Jul 17, 2005
"…patients and their families often are overwrought from bad health news when they are asked to consider participating in a clinical trial. Weighing the potential risks and benefits is even more difficult when in an emotional fog. But recently, a small, yet growing number of clinical research programs have been making efforts to better educate patients and the public about the risks and benefits of participating in trials…"
Belated Charge Ignites Furor Over AIDS Drug Trial, The New York Times, July 17, 2005 (no longer available)
"It was seen as one of the great successes of AIDS treatment…But now, just as the trials are receding into history, they are coming under intense scrutiny…"
NIH Finds Ethics Violations in 44 Cases, The San Francisco Chronicle, July 14, 2005
"The House Energy and Commerce Committee…found 81 cases between 1999 and 2004 where the agreements were not listed in the NIH records provided to the committee. It asked NIH to investigate those cases… Of the 44 scientists found to have violated agency rules, 36 are still employed at NIH and have been referred for possible disciplinary action. Nine of those thirty-six have also been referred to the HHS Office of Inspector General for investigation of possible criminal violations…"
NIH Ethics Problems More Widespread Than Previously Thought, Committee Finds, US House Energy and Commerce Committee Press Release, July 14, 2005
Experts discuss use of human stem cells in ape and monkey brains,, July 14, 2005
"An expert panel of stem cell scientists, primatologists, philosophers and lawyers has concluded that experiments implanting, or grafting, human stem cells into non-human primate brains could unintentionally shift the moral ground between humans and other primates. Writing in the July 15 issue of Science, the panel reports its recommendations for minimizing the chances that experiments with human stem cells could change the cognitive and emotional capabilities -- and hence the "moral status" -- of the animals…"
Perspective: Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees, Steinbrook, New England Journal of Medicine 353:116-118, July 14, 2005 (extract freely available)
Ruling bars 8 Parkinson's patients from new drug type, Cincinnati Enquirer, July 13, 2005
"Eight Parkinson's disease patients who filed a suit to regain access to an experimental drug they said slowed or halted the disease's progression have been turned down by a federal judge…A similar suit was filed in New York in April but was dismissed by a U.S. District Court judge there. The case has been appealed to the U.S. Second Circuit Court of Appeals…"
Study: What's good often turns out bad, Monterey Herald, July 13, 2005
"New research highlights a frustrating fact about science: What was good for you yesterday frequently will turn out to be not so great tomorrow. The sobering conclusion came in a review of major studies published in three influential medical journals between 1990 and 2003, including 45 highly publicized studies that initially claimed a drug or other treatment worked…That means nearly one-third of the original results did not hold up, according to the report in Wednesday's Journal of the American Medical Association…"
Contradicted and Initially Stronger Effects in Highly Cited Clinical Research, Ioannidis, Journal of the American Medical Association 294:218-228, July 13, 2005 (abstract freely available)
Ill. plans $10M for stem cell research, Grand Forks Herald, July 13, 2005
"Illinois became the fourth state to support stem cell research after Gov. Rod Blagojevich circumvented the Legislature and ordered $10 million in tax dollars be used for the controversial research…"
Senators urge change in stem cell rules, Monterey Herald, July 12, 2005
"Senators who want the public to pay for human embryonic stem cell studies said Tuesday that Congress must first pass legislation to lift President Bush's restrictions on such research before paying for unproven alternative methods favored by conservatives. "I'm all for these alternative sources … let's go ahead and pursue them. But we already know how to derive stem cells," said Sen. Tom Harkin, D-Iowa. Harkin, with Sen. Arlen Specter, R-Pa., is sponsoring a House-passed bill to lift Bush's restrictions on stem cell research…"
To read this bill, click here. Enter “HR 810” in search field, select “Enter bill number”, and click on Search.
Ethics, science and human rights come together,, July 12, 2005
"UNESCO has issued a draft declaration it says will be the first ever to commit governments to take a position on the ethical and human rights dilemmas raised by modern research…"
Universal Draft Declaration on Bioethics and Human Rights, UNESCO, June 24, 2005
Week of July 4, 2005
Fake research allegations reach new highs, Monterey Herald, July 10, 2005
"…Allegations of research misconduct reached record highs last year - the Department of Health and Human Services received 274 complaints, which was 50 percent higher than 2003 and the most since 1989 when the federal government established a program to deal with scientific misconduct…"
OHRP announces the availability of two new sets of Frequently Asked Questions (FAQs), which help clarify assurance and IRB registration issues, July 6, 2005
FAQs on Assurance Issues
FAQs on IRB Registration Issues
Parkinson’s patients plead to continue experimental drug, Lexington Herald-Leader, July 5, 2005
"…Today, attorneys for the eight UK patients argued in Lexington federal court that their case was different from the New York lawsuit because a consent form the patients signed before taking part in the Kentucky study…was different from the form patients signed in New York…"
Week of June 27, 2005
AIDS Agency a 'Troubled Organization', The San Francisco Chronicle, July 3, 2005
"The government's AIDS research agency "is a troubled organization" and its managers have engaged in unnecessary feuding, sexually explicit language and other inappropriate conduct that hampers its global fight against the disease, an internal review found…"
Harvard project to scan millions of medical files, Boston Globe, Jul 3, 2005
"Harvard scientists are building a powerful computer system that will use artificial intelligence to scan the private medical files of 2.5 million people at local hospitals, as part of a government-funded effort to find the genetic roots of asthma and other diseases…"
Fate of biomedical research protocols and publication bias in France: retrospective cohort study, Decullier et al., British Medical Journal 331, July 2, 2005 (abstract freely available)
Quality of Parental Consent in a Ugandan Malaria Study, Pace et al., American Journal of Public Health 95: 1184-1189, July 1, 2005 (abstract freely available)
Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis, Matsui et al., Journal of Medical Ethics 31: 385-392, July 1, 2005 (abstract freely available)
Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research, Aksoy, Journal of Medical Ethics 31: 399-403, July 1, 2005 (abstract freely available)
Stopping trials early for commercial reasons: the risk–benefit relationship as a moral compass, Iltis, Journal of Medical Ethics 31: 410-414, July 1, 2005 (abstract freely available)
Building on relationships of trust in biobank research, Hansson, Journal of Medical Ethics 31: 415-418, July 1, 2005 (abstract freely available)
What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics, Garrard and Dawson, Journal of Medical Ethics 31: 419-423, July 1, 2005 (abstract freely available)
FDA Reviews Data for Antidepressant Use in Adults, FDA Talk Paper, July 1, 2005
"In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA) to update patients and healthcare providers with the latest information on this subject…"
Suicidality in Adults Being Treated with Antidepressant Medications, FDA Public Health Advisory, June 30, 2005
Senator prods FDA to put warning on Viagra, Monterey Herald, July 1, 2005
"…Grassley says a safety evaluator at the Food and Drug Administration recommended a Viagra label change on March 1, 2004, but that the label still hasn't been revised…the safety official said the agency was under pressure to approve new drugs and "often safety concerns needed to 'fit in' wherever it could," according to a June 24 letter that Grassley sent to the FDA's acting director, Dr. Lester Crawford…"
Ethical Goals of Community Consultation in Research, Dickert and Sugarman, American Journal of Public Health 95: 1123-1127, July 1, 2005 (abstract freely available)
Written Parental Consent in School-Based HIV/AIDS Prevention Research, Mathews et al., American Journal of Public Health 95: 1266-1269, July 1, 2005 (abstract freely available)
US Senate OKs competing pesticide testing plans, Reuters, June 29, 2005 (no longer available)
"A fight broke out in the U.S. Senate on Wednesday about whether the federal government should be involved in evaluating the safety of pesticides by using human subjects, with senators embracing competing plans…the Senate backed a one-year moratorium on the review of such tests by the U.S. Environmental Protection Agency…the Senate also approved…a different approach…that directs the EPA to issue regulations on ethical standards for using human subjects in tests of pesticide safety within six months of the spending bill becoming law…"
Report: New EPA Proposal Encourages Human Pesticide Experiments, US House of Representatives Committee on Government Reform – Minority Staff Special Investigations Division, June 2005
HHS Appoints Members to National Science Advisory Board for Biosecurity. New Board meets June 30 - July 1, 2005 on "Dual Use" Research, DHHS News Release, June 29, 2005
"…The board will provide advice and recommend specific strategies for efficient and effective oversight of federally conducted or supported dual-use biological research taking into consideration both national security concerns and the needs of the research community…"
Doctors try to harness the power of the placebo, Pittsburgh Post-Gazette, June 28, 2005
"Scientists believe that the placebo effect -- in which patients show improvement even though they are receiving a sugar pill or other sham treatment -- can be exploited to allow doctors to treat various conditionswith lower doses of real drugs and thus minimize side effects, particularly in children…"
Week of June 20, 2005
Black volunteers line up to help find HIV vaccine, Birmingham News, June 26, 2005 (no longer available)
"…UAB's Alabama Vaccine Research Clinic is one of 10 sites in the nation where HIV vaccines are tested, and last year half the participants recruited into its trials were black. About 200 people are now participating in active trials; about 1,000 have participated since the clinic started HIV vaccine trials a decade ago. "We do better than any other site in this country in getting minorities enrolled," said Dr. Scott Parker, co-director of the clinic…"
AbioCor Implantable Heart Replacement Panel Splits Over Risk Vs. Benefit,, June 23, 2005
"…Clyde Yancy, MD, University of Texas Southwestern Medical Center, captured the panel’s ambivalence: “I voted against with some angst. From a clinical perspective, I think the bar was met for probable benefit, given the alternative. But from a regulatory perspective…I don’t think the bar for unreasonable risk was met,” he added…"
The Lessons of Vioxx — Drug Safety and Sales, Waxman, New England Journal of Medicine 352:2576-2578, June 23, 2005 (full article freely available)
New study finds many concerns with clinical trials,, June 21, 2005
"A new study…has looked at current practices in justifying the conduct of clinical trials and found many concerns…some researchers don't look at existing evidence, repeating trials that have already been conducted and scientifically validated…To improve current practices, Dr. Fergusson suggests that investigators be required to conduct more organized reviews of evidence using well-established standards and scientific methods of systematic reviewing. Research ethics boards and journals would be tasked with determining the thoroughness of these efforts…"
Committee seeks records on tissue storage, Monterey Herald, June 20, 2005
"A congressional committee, acting on a complaint by a government scientist, is investigating how the National Institutes of Health maintains samples of human tissue for research…"
NIH Lacks Uniform Protection of Research Samples, Committee Leaders Say, Letter from the US House of Representatives Committee on Energy and Commerce to NIH Director Elias Zerhouni, June 20, 2005
Week of June 13, 2005
EPA using data collected in toxin tests on humans, The San Francisco Chronicle, June 17, 2005
"The Environmental Protection Agency is using data from two dozen tests that deliberately exposed humans to toxic chemicals to help determine whether to approve new pesticides, according to a study released Thursday by congressional Democrats…"
Calif. lawmakers want stop to human pesticide testing, San Diego Union Tribune, June 17, 2005
"A UCSD experiment that included spraying a toxic chemical in the nostrils and eyes of young adults is one of 22 questionable research projects sparking calls for a national moratorium on human pesticide testing. Sen. Barbara Boxer and Rep. Henry Waxman, issued a 38-page report yesterday… “…the experiments appear to have inflicted harm on human subjects, failed to obtain informed consent, dismissed adverse outcomes and lacked scientific validity,” the report says…[UCSD] officials said their research, which ended in 2004, met all legal and ethical standards and participants were fully informed. “There weren't rules broken. Nothing was done in the background or in a breach of public trust. It's pretty normal science,” said Dr. Daniel Masys, former director of UCSD's Human Research Protections Program…"
Waxman and Boxer Release Report on Human Pesticide Experiments, Committee on Government Reform Minority Office Web Site, June 16, 2004 (Waxman statement and report freely available, pdf files)
US faults testing of AIDS drug on foster children, Boston Globe, June 17, 2005
"…The US Department of Health and Human Services' Office for Human Research Protections concluded that Columbia University Presbyterian Medical Center in New York, where several foster children were enrolled in drug studies in the 1990s, failed to obtain and evaluate whether it had proper consent, information, and safeguards for the foster children…"
Panel backs drug for blacks, Boston Globe, June 17, 2005
"A federal panel yesterday recommended approval for the first prescription drug promoted on the basis of racial ethnicity: BiDil, a cardiovascular drug for African-Americans…"
Surgery's next step: face transplants, Monterey County Herald, June 16, 2005 (no longer available)
"Ethicists may find the idea unacceptable, but at least two medical centers in the U.S. are in the final phases of planning for a controversial new procedure: a face transplant…"
Promising drug test, unfulfilled promise, The Houston Chronicle, June 15, 2005 (no longer available)
"Organizers of a high-profile national study failed to fulfill their promise to give a new experimental shingles vaccine to more than 18,000 participants who received a placebo…"
State may require details of drug clinical trials, Portland Press Herald, June 15, 2005 (no longer available)
"Maine could become the first state that requires drug companies to share the results of clinical trials with the public. The bill, expected to be signed today by Gov. John Baldacci, is a response by lawmakers to national cases in which companies did not reveal to physicians and leading medical journals a drug's potential risks…"
US to Review Heart Drug Intended for One Race, New York Times, June 13, 2005 (free one-time registration required; scheduled to be freely available until June 19, 2005, still available)
"This Thursday, eight years after the drug was rejected for use in the general public, an F.D.A. panel will consider whether BiDil should become the first drug intended for one racial group, in this case, African-Americans… BiDil's application has engendered controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug's approval, especially since geneticists have failed to identify a biological divide separating one race from another…"
Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting June 16, 2005, Briefing Information
Week of June 6, 2005
Note: All OHRP telephone numbers have been changed to new phone numbers with a different area code. OHRP's new main number is (240) 453-6900. The toll-free number remains the same, (866) 447-4777. Find an updated directory of office listings here and an updated alphabetical staff listing here.
Doctors and patients think differently about clinical trials,, June 9, 2005
"A survey of patients and physicians regarding clinical trials shows that doctors don't recognize the importance of side effects as a barrier for their patients in deciding about whether to undergo experimental therapy…"
Public-health bill seeks unbiased FDA, CNN Money, June 9, 2005 (no longer available)
"The House of Representatives Wednesday passed a measure to end conflicts of interest among scientists and doctors on Food and Drug Administration advisory panels…"
Office for Human Research Protections (OHRP) Public Education Campaign and Brochure: Taking Part in Research: It's Your Decision, OHRP Web Site, June 8, 2005
"…The centerpiece of the campaign is a one-page pamphlet that guides readers through a series of questions to consider, as they discuss the option of participating in research with their health-care provider, family members and others. OHRP has distributed copies of the pamphlet to some 6,000 research institutions throughout the country, in order to gain broader access to local communities. The pamphlet can be downloaded from this link and reproduced locally. Bulk copies (up to 300 per requestor) are available free by calling 800-444-6472."
Judge Rejects Patients' Suit to Get Test Drug, The New York Times, June 8, 2005 (free one-time registration required; archived, payment required)
"A federal judge has denied a request by two people with Parkinson's disease that he order Amgen to continue giving them a drug they used in a clinical trial that the company discontinued…the informed consent forms signed by the patients before participating in the trial explicitly acknowledged Amgen's right to terminate it…Alan Milstein, the lawyer representing the patients, said he was considering options, including an appeal…"
Survey finds 'questionable' research practices relatively common, Grand Forks Herald, June 8, 2005 (no longer available)
"…One-third of scientists surveyed said that within the previous three years, they'd engaged in at least one practice that would probably get them into trouble, the report said. Examples included circumventing minor aspects of rules for doing research on people and overlooking a colleague's use of flawed data or questionable interpretation of data…"
Expert Panel Opens Drug Safety Hearings, FOX News, June 8, 2005
"Institute of Medicine(IOM) experts began a year's worth of scheduled meetings aimed at quelling safety concerns brought about in part by recent problems with the Cox-2 class of arthritis drugs such as Vioxx and Bextra…"
Project Web Page: Assessment of the U. S. Drug Safety System, Board on Population Health and Public Health Practice, Institute of Medicine
Experts Push for Faster Child Cancer Drugs, The San Francisco Chronicle, June 7, 2005
"…Killian's saga illustrates both the pitfalls and promise of pediatric cancer research. Scientists are finding exciting leads, but few novel therapies for children are in the pipeline. When promising ones do come along, sick youngsters often must wait years for safety testing in adults to be done before they get a shot…"
Making Better Drugs for Children with Cancer, Committee on Shortening the Time Line for New Cancer Treatments, Institute of Medicine and the National Research Council, Apr 18, 2005 (full report freely available)
Recommendations Accepted to Revamp NCI Clinical Trials System, NIH News, June 7, 2005
"The National Cancer Advisory Board (NCAB) of the National Cancer Institute (NCI) today accepted 22 strategic proposals for revamping the NCI's cancer clinical trials system and a five-year implementation plan to accomplish the changes…"
Restructuring the National Cancer Clinical Trials Enterprise, Final Clinical Trials Working Group report to the National Cancer Advisory Board, June 7, 2005
Improved pathway for health research, eGov monitor, June 6, 2005
"A Department of Health report, published today, sets out recommendations for the operation of NHS Research Ethics Committees to ensure applications for good quality research are reviewed consistently, promptly and efficiently by ethics committees…"
Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (pdf file)
Week of May 30, 2005
Speedy drug-review process 'broken', Boston Globe, June 1, 2005
"…Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including those for such blockbuster drugs as the cancer treatment Gleevec, [US Representative Edward J.] Markey alleged. Twenty-one of the studies have not been started, while 18 are on or ahead of schedule, according to Markey's research…"
Markey Press Release and Report, June 1, 2005 (all pdf files)
Ethical concerns regarding guidelines for the conduct of clinical research on children, Edwards and McNamee, Journal of Medical Ethics 31: 351-354, June 1, 2005 (abstract freely available)
Subtle ethical dilemmas in geriatric management and clinical research, Rosin and van Dijk, Journal of Medical Ethics 31: 355-359, June 1, 2005 (abstract freely available)
Recruiting donors for autopsy based cancer research, Thombs et al., Journal of Medical Ethics 31: 360-361, June 1, 2005 (abstract freely available)
Despite Vow, Drug Makers Still Withhold Data, New York Times, May 31, 2005 (free one-time registration required; archived, payment required)
"When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden, scientists independent of the companies say…"
Fast-moving cloning developments spark new worries, The San Francisco Chronicle, May 30, 2005
"Rapid advances in cloning technology have prompted new warnings of lax oversight in one of the most controversial -- and confusing -- realms of science…Two bioethics specialists at Stanford University, Mildred Cho and David Magnus, reviewed the consent forms and other documents used in South Korea and found them to be insufficient in some key respects…"
Week of May 23, 2005
Debate continues about depression treatment device, Monterey Herald, May 29, 2005
"The Vagus Nerve Stimulator has treated hundreds of depression patients in clinical trials across the country. It's on the verge of being the first depression treatment device to be approved by the U.S. Food and Drug Administration. But the progress comes amid questions about whether the device's Houston-based manufacturer, Cyberonics Inc., has sufficiently proven that it's safe and it works…"
Guidance on Reporting Incidents to OHRP, Office for Human Research Protections (OHRP), May 27, 2005
"This document provides guidance about procedures institutions may use to file incident reports with OHRP. Incident reports include reports of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with Department of Health and Human Services (HHS) regulations at 45 CFR part 46 or the requirements or determinations of the institutional review board (IRB); and suspension or termination of IRB approval. In particular, OHRP offers guidance on the following topics: (1) Applicability of incident reporting requirements; (2) information to be included in incident reports; (3) time frame for reporting incidents; (4) OHRP focus on corrective actions when reviewing incident reports; and (5) OHRP's response to incident reports, and (6) additional guidance…"
This guidance is also available here as a pdf document.
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") review process, Office for Human Research Protections (OHRP), May 26, 2005
"This document provides guidance on the HHS 45 CFR 46.407 review process ("407 review process") as required under subpart D of HHS Protection of Human Subjects Regulations at 45 CFR part 46. In particular, the Office for Human Research Protections (OHRP) offers guidance on the following topics: (1) IRB findings necessary to submit a protocol to OHRP for 407 consideration and/or review; (2) steps in the submission process; (3) OHRP's response to submissions; (4) the schedule and details for 407 panel review; and (5) potential outcomes of the 407 review process. This guidance applies to HHS- conducted or -supported research…"
This guidance is also available here as a pdf document.
Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry, Mello et al., New England Journal of Medicine 352:2202-2210, May 26, 2005 (abstract freely available)
Perspective: Gag Clauses in Clinical-Trial Agreements, Steinbrook, New England Journal of Medicine 352: 2160-2162, May 26, 2005 (extract freely available)
Solicitation of Public Review and Comment on Research Protocol: Precursor Preference in Surfactant Synthesis of Newborns. Docket No. 2005N-0184. Pages 30128-30129 [FR Doc. 05-10438], May 25, 2005 (comments due by June 17, 2005)
Electronic copies of the documents for public review can be viewed here, under June 28, 2005 Pediatric Ethics Subcommittee.
To submit comments electronically, click here. Scroll down for Docket 2005N-0184 OR select “Docket Search” in top left corner of screen and enter 2005N-0184 in Docket ID, then select “Find”.
Drug companies influence medical research, Seattle Post-Intelligencer, May 25, 2005 (no longer available)
"Many U.S. medical schools are willing to give companies that sponsor studies of new drugs and treatments considerable control over the results, according to survey results that some doctors found troubling…"
Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry, Mello et al., New England Journal of Medicine 352:2202-2210, May 26, 2005 (abstract freely available)
House OKs bill to ease stem cell limits, The San Francisco Chronicle, May 25, 2005
"The House passed legislation Tuesday that would reverse President Bush's 2001 decision to severely limit embryonic stem cell research, but the White House called the vote "morally troubling" and reiterated Bush's intention to veto the bill if the Senate approved it…"
Enlisting addicts for study proves difficult, The Globe and Mail, May 24, 2005 (archived, free registration required)
"The clinic is ready and the government-supplied heroin is waiting to be injected, but researchers undertaking the first drug study of its kind in North America are having trouble finding enough addicts…"
Editor: Drug firms don't disclose enough, Monterey Herald, May 24, 2005
"Pfizer Inc., GlaxoSmithKline PLC. and Merck & Co. are "making a mockery" of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor…"
Is This Clinical Trial Fully Registered? A Statement From the International Committee of Medical Journal Editors, New England Journal Medicine Early Release May 23, 2005 (payment now required)
Is This Clinical Trial Fully Registered? A Statement From the International Committee of Medical Journal Editors, Journal of the American Medical Association 293, Early Release May 23, 2005 (full statement freely available)
Potential Impact of the HIPAA Privacy Rule on Data Collection in a Registry of Patients With Acute Coronary Syndrome, Armstrong et al., Archives of Internal Medicine 165:1125-1129, May 23, 2005 (abstract freely available)
Week of May 16, 2005
Cancer study raises concern, hope. Prevention drug tested on healthy, Concord Monitor, May 22, 2005
"…The study that Hart joined and a similar one based in Europe are raising hope that a new class of drugs may offer women at high risk of breast cancer a safe way to protect themselves. But the experiments also raise thorny questions about whether the potential benefits outweigh the risks…"
Bioethics and Child Testing , National Public Radio, May 22, 2005 (requires Windows Media Player or Real Player)
"All Things Considered Host Jennifer Ludden talks with Marjorie Speers, Ph.D., about the safety protocol and ethical questions surrounding drug studies that involve children. Speers is the executive director of the Association for the Accreditation of Human Research Protections Programs…"
FDA Web site warns of drug risks, The Seattle Times, May 21, 2005
"The Food and Drug Administration has begun issuing alerts to patients and doctors on its Web site about emerging drug-safety concerns, including dangers posed by drugs prescribed for unapproved purposes…"
FDA's New Drug Safety Initiative, FDA Website, May 18, 2005
FDA introduces rules aimed at limiting drug-makers' influence, Monterey Herald, May 20, 2005 (no longer available)
"Senior officials of the Food and Drug Administration unveiled new drug-safety rules Friday aimed partly at reducing the influence of drug-makers on certain FDA actions…"
FDA Announces Membership of Drug Safety Oversight Board, FDA Talk Paper, May 18, 2005
Use of foster kids in experiments varies, Grand Forks Herald, May 18, 2005 (no longer available)
"Current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected, a Bush administration official said Wednesday…"
House Ways and Means Committee, Subcommittee on Human Resources, Hearing on Protections for Foster Children Enrolled in Clinical Trials, Witness List, Testimonies and Additional Hearing Materials, May 18, 2005
Week of May 9, 2005
Ethics team advises on embryo cell alternatives, Reuters, May 12, 2005 (no longer available)
"Embryos that have died during test-tube baby attempts, cells taken from embryos without harming them or even recharged adult skin cells might provide alternatives to embryonic stem cells for research, White House ethics advisers said on Thursday…"
White Paper: Alternative Sources of Pluripotent Stem Cells, The President's Council on Bioethics, May 2005 (full document freely available)
FDA Draft Guidance for Industry on the Food and Drug Administration's Drug Watch for Emerging Drug Safety Information, Federal Register pp. 24606-24607 [FR Doc. 05-9297] Docket No. 2005D-0062, CDER 4161, May 10, 2005 (Comments on draft guidance due by August 8, 2005)
"This document provides guidance about how FDA intends to develop and disseminate important emerging drug safety information concerning marketed drug products to healthcare professionals and patients. This information will appear on an FDA Web page to be called the “Drug Watch.”…"
The Draft Guidance (pdf file)
The Draft Guidance (Word file)
Questions and Answers on FDA's New Drug Safety Initiative, FDA Website, May 5, 2005
To submit comments electronically, click here. Scroll down for Docket 2005D-0062 OR select “Docket Search” in top left corner of screen and enter 2005D-0062 in Docket ID, then select “Find”.
Patients were guinea pigs and didn't know it,, May 9, 2005 (no longer available)
"The State Comptroller's Report features a laundry list of grave oversights and continuous negligence on the part of the Health Ministry and public hospital management regarding their supervisory role in the performance of thousands of experiments and research studies in which hospital patients were subjects…"
Magnetic treatment clinic draws controversy, Arizona Daily Star, May 9, 2006
"A new and controversial Tucson clinic that promises hope for people suffering from incurable and often untreatable medical problems has triggered widespread skepticism throughout the local medical community and may face the scrutiny of federal health authorities…all patients undergoing this therapy at the local clinic must sign a consent form stating that they understand it's under research and may not provide a cure…"
Week of May 2, 2005
Lawsuits against UA researcher move to state court,, May 5, 2005
"Lawsuits that accuse a University of Arizona professor of duping members of the Havasupai Tribe into giving their blood for genetics research have been moved from federal to state court…"
Selling Vioxx: Merck used code-named projects to boost sales despite safety concerns, The Seattle Times, May 5, 2005
"Merck & Co. sales personnel, using projects code-named "Offense" and "XXceleration," took extensive measures to boost sales of the painkiller Vioxx amid brewing safety concerns…"
Merck Documents Show Aggressive Marketing of Vioxx After Studies Indicated Risk, Committee on Government Reform Minority Office, US House of Representatives, May 5, 2005
"Rep. Waxman releases an analysis of over 20,000 pages of documents that suggests that Merck sent more than 3,000 highly trained representatives into doctor's offices and hospitals armed with misleading information about Vioxx's risks…"
AP: Feds Tested AIDS Drugs on Foster Kids, The San Francisco Chronicle, May 5, 2005
"To gain access to hundreds of HIV-infected foster children, federally funded researchers promised in writing to provide an independent advocate to safeguard the kids' well-being as they tested potent AIDS drugs. But most of the time, that special protection never materialized, an Associated Press review has found…"
Documents obtained by AP for this story are available here. (All pdf files)
The Research on Adverse Drug Events and Reports (RADAR) Project, Bennett et al. Journal of the American Medical Association 293:2131-2140, May 4, 2005 (abstract freely available)
Drug-tracking project may aid FDA efforts, The Boston Globe, May 4, 2005
"The Research on Adverse Drug Events and Reports project uses 25 researchers at medical centers around the nation to study data, including unpublished clinical trials. The team has uncovered potentially fatal problems with scores of devices and drugs…"
The Research on Adverse Drug Events and Reports (RADAR) Project, Bennett et al. Journal of the American Medical Association 293:2131-2140, May 4, 2005 (abstract freely available)
Cancer patients see Phase I drug trials as last, best hope, The Birmingham News, May 2, 2005 (no longer available)
"When Deborah Rutledge's cancer relapsed, she didn't have many options left…"
Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002, Horstmann et al. New England Journal of Medicine 352: 895-904, Mar 3, 2005 (abstract freely available)
Week of April 25, 2005
Methodological quality and reporting of ethical requirements in phase III cancer trials, Tuech et al. Journal of Medical Ethics 31:251-255, May 1, 2005 (abstract freely available)
UW halts research involving prisoners, Seattle Times, Apr 29, 2005
"University of Washington officials have halted three research projects involving prisoners until federal authorities approve the work, university officials said yesterday. The action, reported to the federal Office for Human Research Protections (OHRP), was in partial response to a range of concerns presented this month about the UW's treatment of research subjects…"
Senators seek drug safety center, The Boston Globe, Apr 28, 2005
"The head of a new drug safety center charged with monitoring drug risks would answer directly to the Food and Drug Administration commissioner under a bill introduced yesterday. The measure is intended to eliminate conflicts of interest by separating the FDA's oversight of approved medications from its drug-approval process…"
To read the text of this bill, click here. In the search field, select Bill Number and enter S930.
Press release: Grassley, Dodd Expand Effort to Improve Drug Safety, United States Senate, Apr 27, 2005 (pdf file)
Secretary's Advisory Committee on Human Research Protections (SACHRP), April 18 -19, 2005 Meeting Presentations and Report, posted Apr 28, 2005
Correspondence: The Cost of Institutional Review Boards in Academic Medical Centers, Sugarman et al., New England Journal of Medicine 352:1825-1827, April 28, 2005 (extract freely available)
Parkinson's Patients Suing Amgen Over Drug, The New York Times, Apr 27, 2005 (free one-time registration required; scheduled to be freely available until May 3, 2005, no longer available)
"Two participants in a discontinued clinical drug trial have sued Amgen, demanding that it resume giving them an experimental treatment for Parkinson's disease that they say helped them immensely but that the company says is ineffective and potentially dangerous…"
Top science group offers stem cell ethics rules, The San Francisco Chronicle, Apr 27, 2005
"The nation's most respected scientific organization proposed ethical guidelines for human embryonic stem cell research Tuesday, offering a system of institutional self-policing as a way to move the politically contentious research forward…"
Press Release: Guidelines Released for Embryonic Stem Cell Research, National Academies of Sciences, Apr 26, 2005
Report: Guidelines for Human Embryonic Stem Cell Research, Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council, April 26, 2005
Week of April 18, 2005
Agency seeks review of kids' drug trials, Monterey County Herald, Apr 23, 2005 (no longer available)
"A city agency that put more than 400 HIV-positive foster children into clinical trials for AIDS drugs has asked for an independent review of the program after children's rights advocates said it amounted to exploitation…"
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1), Krleza-Jeric et al., British Medical Journal 330:956-958, April 23, 2005 (extract freely available)
Commentary: Why industry should register and disclose results of clinical studies—perspective of a recovering academic, Berlin, British Medical Journal 330:959, April 23, 2005 (extract freely available)
Congress probes concerns at NIH, The Boston Globe, Apr 22, 2005
"Congressional committees have begun investigating allegations that female officers inside the nation's premier health research agency were sexually harassed and their concerns about safety in human experiments disregarded…"
FDA investigating clinic where patient died, Houston Chronicle, Apr 21, 2005 (no longer available)
"…"The FDA's Center for Drug Evaluation and Research believes you have repeatedly or deliberately violated regulations governing the proper conduct of clinical studies," Dr. Joanne Rhoads, director of the center's division of scientific investigations, wrote Dr. Louis Fabre, the head of the clinic, in a Jan. 19 letter…"
Blacks needed in clinical trials, experts say, The State, Apr 20, 2005 (no longer available)
"…The need to draw more African-Americans like Jordan into clinical trials is one of the vexing problems contributing to the disparity between the health of blacks and whites, experts say…"
UW told to tighten research oversight, Seattle Times, Apr 20, 2005
"The federal government has warned the University of Washington that it needs to tighten its oversight of research conducted on human subjects…"
FDA requests anticonvulsants be reexamined, The Boston Globe, Apr 20, 2005
"The Food and Drug Administration has asked the makers of epilepsy drugs, which are the fifth best-selling group of medications and are taken by millions of Americans, to reexamine their data to determine if the drugs increase patients' risk of suicide…"
My Body on the Line, Washington Post, Apr 19, 2005 (free one-time registration required)
"I am lying on an exam table at Strong Memorial Hospital in Rochester, N.Y. I stare at the ceiling and try to keep my legs apart while nurse practitioner Kay Rust threads a catheter through my urethra and instills a cool liquid into my bladder. This is not part of any usual exam, and I would rather be just about anyplace else on earth. But I lie here quietly because I volunteered for a National Institutes of Health (NIH) double-blind clinical trial…"
Is a Trial For You?, Washington Post, Apr 19, 2005 (free one-time registration required)
"So you're interested in taking part in a clinical trial, you say -- if only someone could just answer some basic questions and reassure you about the fine points. Where do you begin your search for reliable information?…"
Establishing Proof, Washington Post, Apr 19, 2005 (free one-time registration required)
"Some fifty years ago a baby-blinding epidemic confounded experts -- until a pioneering study conclusively tied cause and effect, and enshrined clinical trials in medical practice…"
Week of April 11, 2005
Dosanjh announces new drug safety measures,, Apr 17, 2005
"A series of measures to enhance drug safety in Canada, including a public forum to address concerns about arthritis medication, were announced by federal Health Minister Ujjal Dosanjh on Saturday…"
Office for Human Research Protections (OHRP) New Web Page: the Belmont Report Historical Archive, Apr 15, 2005
"The Belmont Archive includes: Belmont Report Oral History Interviews (video versions will be added at a future date), Training Video (9-minute educational/training video), Commemorative Program Video (1 hour edited version of the November 16, 2004 Department of Health and Human Services (HHS) ceremony honoring the National Commission), and History of the Belmont Report (short history of the Belmont Report and the current human subject protection regulations). "
Geographic Society Is Seeking a Genealogy of Humankind, The New York Times, Apr 13, 2005 (free one-time registration required; archived, payment required)
"A five-year project to reconstruct a genealogy of the world's populations and the migration paths of early humans from their ancestral homeland in Africa will be started today by the National Geographic Society and I.B.M., the society said in a statement. The goal of the program is to collect 100,000 blood samples from indigenous populations around the world and analyze them genetically…"
Activists Attack Ethics of Pfizer AIDS Drug Trial, Reuters, Apr 12, 2005 (no longer available)
"A clinical study into an experimental AIDS pill made by Pfizer Inc, the world's biggest drugmaker, should be halted because it offers patients no safety net, activists said Tuesday…"
Week of April 4, 2005
NIH Women Describe Sex Harrassment, The San Francisco Chronicle, Apr 10, 2005
"Women at the National Institutes of Health faced sexual intimidation and repeated disregard of their concerns for the welfare of patients in AIDS experiments, according to testimony by two senior female officers and documents gathered by investigators…"
Associated Press Documents referred to in this story
Once 'too slow,' FDA approvals called 'too fast', The Boston Globe, Apr 10, 2005
"Over 15 years, the Food and Drug Administration has swung from taking too long to get medicine to dying AIDS patients to drawing fire for rushing drugs to market that wound up killing people…The profound change within the agency came from several directions…"
EPA nominee kills embattled study, is cleared for vote, The Seattle Times, Apr 9, 2005
"A controversial program to pay parents to document the effects of pesticide exposure on their children was canceled yesterday by the acting head of the Environmental Protection Agency, whose confirmation to the post has been jeopardized by the study…"
Children's Environmental Exposure Research Study (CHEERS), EPA Web Site, updated Apr 8, 2005
Panel: AIDS study OK despite violations, The Boston Globe, Apr 7, 2005
"Controversial U.S. research in Africa that violated federal patient protection rules was nevertheless conducted well enough to support its conclusions that the AIDS drug nevirapine could be used safely to protect babies, an expert scientific panel has concluded…"
Review of the HIVNET 012 Perinatal HIV Prevention Study, Committee on Reviewing the HIVNET 012 Perinatal HIV Prevention Study, Board on Population Health and Public Health Practice, Institute of Medicine, Apr 7, 2005
NIH Director Zerhouni Says He Will Seek Changes in New Conflict-Of-Interest Rules, Medical News Today, Apr 7, 2005
"NIH Director Elias Zerhouni on Wednesday at a Senate Labor-HHS Appropriations Subcommittee hearing said that he will seek to alter the agency's new conflict-of-interest rules because it is "very clear" that a provision requiring employees to divest health-related stock would have a "deleterious impact" on NIH…"
Top scientists press for more stem cells, The San Francisco Chronicle, Apr 7, 2005
"With some Republicans pressing to loosen President Bush's restrictions on federal financing for embryonic stem cell research, the director of the National Institutes of Health said Wednesday that there is mounting evidence that such a policy change would benefit science, and other top NIH officials echoed his assessment…"
Pfizer Takes Painkiller Bextra Off Market, The San Francisco Chronicle, Apr 7, 2005
"The painkiller Bextra was taken off the market Thursday, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them…"
FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), FDA News, Apr 7, 2005
FDA Web Page for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
If placebos work, should doctors use them?, Christian Science Monitor, Apr 7, 2005 (scheduled to be freely available until Apr 12, 2005, still available)
"Most people think of placebos as harmless "sugar pills" given in clinic trials to some participants so that medical researchers can gauge the effects of the real drug on others. But in some trials, the "placebo effect" proves to be as strong as that of the drug…over the decades a small band of researchers has taken a hard look at those pills. Are they really effective? Should they play a role in medical therapy?…"
Articles from Archives of Pediatrics and Adolescent Medicine 159, April 2005 (extract or abstract freely available)
Improving the Readability and Processability of a Pediatric Informed Consent Document: Effects on Parents’ Understanding, Tait et al., pp. 347-352
Editorial: Moving Beyond the Consent Document in Research on Informed Consent, Miller and Nelson, pp. 396-397
Week of March 28, 2005
Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors, Chan and Altman, British Medical Journal 330: 753, Apr 2, 2005 (abstract freely available)
"Conclusions: Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance. The medical literature therefore represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available…"
Articles from the Journal of Medical Ethics 31, Apr 1, 2005 (abstracts or extracts freely available)
How should we measure informed choice? The case of cancer screening, Jepson et al.
Legitimate requests and indecent proposals: matters of justice in the ethical assessment of phase I trials involving competent patients, Kong
Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis, Kimmelman and Palmour
Scientific research is a moral duty, Harris
Use of stem cells in California creates ethical dilemma, Grand Forks Herald, Mar 31, 2005 (no longer available)
"…But some women's groups fear egg donors will face health risks. They worry that scientists do not know all the long-term impacts of the drugs women will receive to stimulate ovulation. Some question whether voters knew the ramifications when they passed Proposition 71 in November…"Before you start saying all these women can go be egg donors, you need to have somebody look out for their welfare who's not going to get money from it and not getting research grants," said Dr. Suzanne Parisian, a former Food and Drug Administration chief medical officer…"
Free Heroin, Montreal Mirror, Mar 31, 2005
"A new scientific study investigates the potential benefits of giving hard-core addicts their daily doses…"
Perspectives from the New England Journal of Medicine 352, Mar 31, 2005 (extracts freely available)
Raising the Safety Bar — The FDA's Coxib Meeting, S. Okie
Learning the Value of Drugs — Is Rofecoxib a Regulatory Success Story?, R.S. Eisenberg
Standards of Ethics at the National Institutes of Health, R. Steinbrook
Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Federal Register 70, 15635-15636 [FR Doc. 05-05977], FDA Docket No. 2005D-0103, OC 2004273, Mar 28, 2005 (comments due May 27, 2005)
"…The draft guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA's regulations by facilitating the use of a centralized IRB review process…"
The Draft Guidance (Word version)
The Draft Guidance (PDF version)
Research With Stored Biological Samples: What Do Research Participants Want? Chen et al. Archives of Internal Medicine 165:652-655, Mar 28, 2005 (abstract freely available)
"Conclusions: Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so…"
Week of March 21, 2005
Protection of Human Subjects; Proposed Criteria for Determinations of Equivalent Protection, Federal Register 70 p. 15322-15327, Mar 25, 2005 (pdf file; comments due by May 24, 2005)
"OHRP invites public comment on recommendations made by a workgroup formed by the Department of Health and Human Services (HHS). The workgroup examined criteria that HHS might use in implementing the authority in 45 CFR 46.101(h). That authority permits HHS to find that "procedures normally followed in the foreign countries to protect human subjects … afford protections that are at least equivalent to those provided in" the HHS regulations. Where such a finding is made, HHS "may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in" the HHS regulations…"
Report of the Equivalent Protections Working Group, Department of Health and Human Services, July 17, 2003 (pdf file)
Appendix, Report of the Equivalent Protections Working Group, DHHS (pdf file)
Adverse Events Definition Should Be Narrower, IRB Groups Tell FDA,, Mar 25, 2005
"The Consortium of Independent Review Boards is calling for a more restrictive definition of suspected adverse drug events observed during clinical trials…"
Applied Research Ethics National Association (ARENA) Testimony (pdf file)
US Drug Trials Proposal Unethical, Critics Say, Reuters, Mar 24, 2005 (no longer available)
"The U.S. Food and Drug Administration is flouting ethical practice by proposing that international guidelines protecting patients need not apply to clinical trials conducted abroad, critics said on Thursday…"
The Lancet Comment referenced in this news article is available at:
US exceptionalism comes to research ethics, Lurie and Greco, Lancet 365, Mar 26, 2005 (no longer available)
Tribe suing university researcher over misused blood samples,, Mar 24, 2005
"The tribe that lives in a remote area of the Grand Canyon is suing a university researcher, claiming that blood samples taken from tribal members for diabetes testing were misused…"
U.S. Guidelines Aim to Spark Genetic Drug Research, Reuters, Mar 22, 2005 (no longer available)
"Hoping to spur a movement toward "personalized medicine," U.S. regulators issued guidelines on Tuesday that urge companies to submit data on how genetic differences affect the way people respond to drugs…"
Genomics at FDA Web Page, Posted Mar 22, 2005
Three Affiliated Tribes working on review board for research, Grand Forks Herald, Mar 22, 3005 (no longer available)
"Anyone planning to conduct federally financed scientific and cultural research on the Fort Berthold reservation will have to get permission from a tribal review board…"
Week of March 14, 2005
Congress planning overhaul at NIH, The Boston Globe, Mar 20, 2005
"…Congress is thinking about pruning that Bethesda bramble by reauthorizing the agency -- a process that gives legislators an opportunity to make structural and administrative changes beyond those they make indirectly through the budgeting process…"
FDA accepts weakened antidepressant warning, British Medical Journal 330:620, Mar 19, 2005 (extract freely available)
"New "black box" warnings will appear this month in the United States on antidepressant labels about the risk of increased suicidality among children using the drugs. The warnings initially advised by the US Food and Drug Administration, however, have been weakened by industry, say critics…"
Nuffield council calls for ethical framework for developing world research, British Medical Journal 330:618, Mar 19, 2005 (extract freely available)
"A sound ethical framework for research in developing countries is crucial for ensuring that participants are safe from exploitation, says a report from the Nuffield Council on Bioethics. But some of the measures introduced to try to offer such protection—such as arguing that participants should have access to the same standards of care made available in developed countries—are impractical and can undermine potential research opportunities, it says…"
The Ethics of Research Related to Healthcare in Developing Countries, Nuffield Council on Bioethics, Mar 17, 2005
A new setback for gene therapy, The Seattle Times, Mar 18, 2005
"…yesterday one of the stalwarts of the cystic-fibrosis field, Seattle-based Targeted Genetics, dropped out. In the largest clinical trial ever conducted of gene therapy for cystic fibrosis, with 102 patients, the company failed to reach its goal of helping patients breathe significantly better, even for a month. The failure is another blow to a field that's seen hype from the early 1990s turn into frustration in recent years…"
Researcher admits fraud in grant data, The Boston Globe, Mar 18, 2005
"In the worst case of scientific fakery to come to light in two decades, a top obesity researcher who long worked at the University of Vermont admitted yesterday that he fabricated data in 17 applications for federal grants to make his work seem more promising, helping him win nearly $3 million in government funding…"
Office of Research Integrity (ORI) Misconduct Finding: Dr. Eric T. Poehlman
UK's Wellcome Trust issues ethics guidelines,, Mar 18, 2005
"A leading funder of research on HIV/AIDS, malaria and tuberculosis yesterday (17 March) issued its first ethical guidelines for studies it funds in developing countries…"
Wellcome Trust-Funded Research Involving People Living in Developing Countries: Position Statement and Guidance Notes for Applicants
FDA nominee says he's open to changes at embattled agency, Monterey Herald, Mar 17, 2005 (no longer available)
"Lester Crawford, the Bush administration's nominee to head the Food and Drug Administration, assured lawmakers Thursday that he'd consider numerous changes to the troubled regulatory agency, including making its Office of Drug Safety independent of the division that now manages it…"
The editorial referenced in this news report is available at:
What Ails the FDA?, Okie, New England Journal of Medicine 352:1063-1066, Mar 17, 2005 (extract freely available)
Statement of FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Senate Committee on Health, Education, Labor and Pensions; subject: confirmation hearing for Crawford's nomination as FDA commissioner, Mar 17, 2005
FHI Cancels Nigerian Arm of Clinical Trial Testing Tenofovir for HIV Prevention, Medical News Today, Mar 17, 2005
"Family Health International on Monday announced that it has cancelled the Nigerian arm of an ongoing clinical trial testing Gilead's antiretroviral drug Viread because of a failure of local researchers to reach "necessary scientific standards,"…"
AIDS Panel Gets Money From Agency in Probe, The San Francisco Chronicle, Mar 16, 2005
"Two-thirds of the members serving on an expert medical panel investigating a U.S.-funded AIDS study are receiving grant money from the federal agency at the center of the probe, according to documents and interviews…"
GlaxoSmithKline: FDA halts trials of drug, The Seattle Post-Intelligencer, Mar 16, 2005 (no longer available)
"European drugmaker GlaxoSmithKline PLC said Wednesday it had suspended clinical trials of an experimental drug to treat multiple sclerosis and Crohn's disease, in line with a U.S. regulator's ruling…"
A Body’s Burden: Our Chemical Legacy. How the project was reported, Oakland Tribune, Mar 14, 2005
"It's not easy to get blood from an 18-month-old…That was a chief hurdle confronting the Oakland Tribune's nine-month investigation of consumer and industrial contaminants in our bodies…Government- or university-funded research using human subjects needs approval from such a board…The paper did not need such approval but sought it after several scientists said a newspaper-sponsored project should, in fairness, play by the same rules…"
Redacted Protocol
Redacted consent
Other story resources
Human drug trials to come under strict regulatory vigil, Financial Express (India), Mar 13, 2005
"The Central Drug Standard Control Organisation (CDSCO) has initiated steps to strictly monitor trials of new drugs on humans by multinational and domestic pharma companies. The CDSCO has also sought the help of healthcare professionals to keep a close tab on the adverse events (AE) of various drugs marketed in the country…"
Week of March 7, 2005
Public financing of cloning imminent, concern over donors rises, San Diego Union Tribune, Mar 11, 2005
"Of all the questions about California's ambitious plans to publicly finance human cloning projects for medical research, one of the thorniest may be how scientists plan to gather the thousands of eggs they'll need from women…"
Study participants want to know the results, Reuters, Mar 11, 2005 (no longer available)
"People who participate in clinical studies are interested in how the trials turn out, results of a small pilot study suggest…"
Offering participants results of a clinical trial: sharing results of a negative study, Partridge et al. Lancet 365: 963-64, Mar 12, 2005 (free one time registration required; abstract freely available)
Senator Says FDA Needs Independent Safety Office, Reuters, Mar 10, 2005 (no longer available)
"The U.S. Food and Drug Administration needs an independent drug safety office with the power to order warning labels on dangerous medicines and suspend television ads while potential side effects are under investigation, a top Senate Republican said on Thursday…"
Alternative NIH ethics rules, The Scientist, Mar 10, 2005
"Arguing that recently announced conflict of interest rules at the National Institutes of Health (NIH) will "severely and irreparably compromise the NIH's mission," a group representing several thousand intramural scientists yesterday (March 9) proposed less restrictive regulations on outside consulting, editing and writing, and stock ownership…"
Thais protest anti-AIDS drug trial, Monterey Herald, Mar 10, 2005 (no longer available)
"Thai health activists on Thursday protested plans to test an anti-AIDS drug on hundreds of volunteers, claiming it failed to meet ethical standards…"
Drug Companies Export Trials to China, New Markets, Reuters, Mar 9, 2005 (no longer available)
"Western drugmakers are shifting more clinical trials to emerging markets in a bid to save money, speed research and educate a new generation of local doctors about their products. Just how far the trend has gone was highlighted on Wednesday when Sanofi-Aventis SA, Bristol-Myers Squibb Co and AstraZeneca Plc announced results from a 46,000-patient trial of two drugs in China…At a time when patient recruitment has become more difficult in the United States, western Europe and Japan, other parts of the world can offer better and faster access to patients…"
Secretary's Advisory Committee on Human Research Protections (SACHRP), Jan 31 - Feb 1, 2005 Meeting Presentations, posted Mar 8, 2005
Week of February 28, 2005
Medical trials depend upon volunteers who put selves on the line, Monterey County Herald, Mar 4, 2005 (no longer available)
"As Randall Schilling lay upon a treatment table at Barnes-Jewish Hospital in St. Louis, he thought of how the risk he was taking could help someone…"
Gene-therapy trials suspended, The Seattle Times, Mar 4, 2005
"The Food and Drug Administration has suspended several U.S. gene-therapy experiments after learning that a third child who underwent treatment in France has developed cancer as a result…"
FDA official: Agency doesn't need more regulatory powers, Monterey County Herald, Mar 3, 2005 (no longer available)
"A senior Food and Drug Administration official backed off Thursday from calls for new and greater FDA regulatory powers over the drug industry…"
Study: Experimental cancer treatments help, Monterey County Herald, Mar 2, 2005 (no longer available)
"People with advanced cancers who try experimental treatments are helped more than previously thought, according to the most comprehensive look at government-sponsored tests over a decade…"
Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002, Horstmann et al. New England Journal of Medicine 352: 895-904, Mar 3, 2005 (abstract freely available)
Impact of Participant and Physician Intervention Preferences on Randomized Trials, King et al., Journal of American Medical Association 293:1089-1099, March 2, 2005 (abstract freely available)
"Conclusions:  Preferences influence whether people participate in randomized trials, but there is little evidence that they significantly affect validity."
FDA Seeks Power on Drug Warning Labels, The San Francisco Chronicle, Mar 1, 2005
"The Food and Drug Administration wants the power to write warning labels for drugs, telling Congress on Tuesday it would help end the haggling with pharmaceutical companies that delayed warnings to Vioxx users about potential heart problems…"
US Senate Committee on Health, Education, Labor and Pensions, Witness Testimonies
FDA’s Drug Approval Process: Up to the Challenge?, Mar 1, 2005
Ensuring Drug Safety: Where Do We Go From Here?, Mar 3, 2005
Biogen calls halt to its MS drug, The Boston Globe, Mar 1, 2005
"Biogen Idec Inc. of Cambridge yesterday abruptly told doctors to stop using its new multiple sclerosis treatment, Tysabri, and halted shipments and clinical trials involving the drug after one patient who had taken the drug in trials died from a rare brain virus…"
FDA Public Health Advisory: Suspended Marketing of Tysabri (natalizumab), Feb 28, 2005
A Model Designed to Enhance Informed Consent: Experiences From the HIV Prevention Trials Network, Woodsong and Karim, American Journal of Public Health 95: 412-419, Mar 1, 2005 (abstract freely available)
"…This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: pre-enrollment, enrollment, and post-enrollment…"
Fair Access to Clinical Trials (FACT) Act, Introduced in the US Senate Feb 28, 2005
Select “Enter Bill Number” and type in “S470” in the Search Box in the upper left corner of screen.
Senators Seek Mandatory Drug Study Database, Reuters, Feb 28, 2005 (no longer available)
"Drug and medical device companies would be required to report clinical trial results in a public database under legislation unveiled on Monday by a top U.S. Senate Republican and three Democrats…"
Grassley Co-Sponsors Clinical Trial Registry Legislation, US Senate Committee on Finance News Release, Feb 28, 2005 (pdf file)
Week of February 21, 2005
British Medical Journal (BMJ) Special Education and Debate Section, Feb 26, 2005 (extracts freely available):
Editorial: Ethics review of research and audit, Abbasi and Heath, British Medical Journal 330: 431-432
Ethics, audit, and research: all shades of grey, Wade, British Medical Journal 330: 468-471
Commentary: patients may be less risk averse than committee, Nurock, British Medical Journal 330: 471-472
Commentary: Research ethics committees deserve support, Alexander, British Medical Journal 330: 472-473
Commentary: ethical review and ethical behaviour, McMillan and Sheehan, British Medical Journal 330: 473
Cameroon Health Ministry Agrees To Allow Follow-Up in Viread Trial, Medical News Today, Feb 26, 2005
"…The health ministry last week agreed that FHI could conduct follow-up study on participants already enrolled in the study "without interruption,"… FHI has pledged to help find ways for participants who become infected with HIV during the clinical trial to access antiretroviral treatment…"
Douala Aids Drug Controversy: Medical Council Says Trials Violated Ethical Norms,, Feb 24, 2005 (archived; paid subscription required to access archive)
"An ad hoc commission set up by the Cameroon National Medical Council, CNMC, to investigate into the controversial Tenofovir AIDS drug trials on sex workers in Douala has concluded that the promoters violated ethical norms. The findings of the commission, headed by Prof. Tetanye Ekoe, contradicted that of the audit commission set up by the Minister of Public Health that did not find any ethical problems with the clinical trials…"
Family Health International (FHI) statement Participant Follow-up Resumed in FHI's Oral Tenofovir Study in Cameroon, February 22, 2005
NIH sees fight on ethics rules, The Scientist, Feb 25, 2005
"Senior scientists and others at the National Institutes of Health (NIH) are preparing legal challenges to recently announced ethics regulations barring them from owning stock in drug and biotech companies and from consulting with universities and academic institutions…"
FDA painkiller panel advisers linked to pharmaceutical firms, The San Francisco Chronicle, Feb 25, 2005
"Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records. If the 10 advisers had not voted, the committee would have voted 12-8 that Bextra should be withdrawn and 14-8 that Vioxx should not return to the market…"
She's dying: His drug could save her. The Hook, Feb 24, 2005
"…In late November, UVA's [University of Virginia’s] Human Investigation Committee turned down Bennett's request for an extension…The Committee had approved Bennett for a Phase I study, in which a drug is tested only for safety-- not for any positive medical results he might observe…Gentry says she understands the need for solid science. As a nurse at UVA, she helped conduct several research studies. But what she doesn't understand is how the Committee can claim safety as an issue when no subjects showed signs of complications…"
Most U.S. health researchers cleared, The San Francisco Chronicle, Feb 23, 2005
"Most of the 100 or so National Institutes of Health researchers that the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, agency officials said…"
Ohioans volunteered for secret chemical warfare tests during World War II, Columbus Dispatch, Feb 22, 2005 (scheduled to be available until Feb 28, 2005, still available)
"…thousands of World War II veterans became subjects for secret chemical warfare tests…"
UN bans reproductive cloning, The Scientist, Feb 21, 2005
"The legal committee of the United Nations' General Assembly voted on Friday (February 18) by a slim majority in favor of a non–legally binding agreement that asks member states to prohibit reproductive cloning and adopt legislation to respect "human dignity" and "human life."…"
FDA Moves Toward More Openness With the Public, The New York Times, Feb 20, 2005 (free registration required; archived, payment required)
"Almost every headline about the remarkable hearings this week by a federal drug advisory panel focused on whether several huge-selling pain pills were safe. Just as significant, though, was what may well be the start of a cultural transformation at the Food and Drug Administration…"
Painkillers could stay on market with warnings, The Seattle Times, Feb 19, 2005
"A Food and Drug Administration advisory panel voted yesterday to let doctors prescribe COX-2 painkillers, including Vioxx and Celebrex, but backed stronger warnings about the risk of heart attacks and strokes…"
Week of February 14, 2005
F.D.A. to Create Advisory Board on Drug Safety, The New York Times, Feb 16, 2005 (free registration required; archived, payment required)
"Responding to widespread criticism of the government's handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs…"
Reforms Will Improve Oversight and Openness at FDA, Health and Human Services (HHS) News Release, Feb 15, 2005
FDA Improvements in Drug Safety Monitoring, FDA Fact Sheet, Feb 15, 2005
Bush Taps Crawford to Run U.S. FDA, Reuters, Feb 14, 2005 (no longer available)
"President Bush on Monday named Lester Crawford to serve as commissioner of the Food and Drug Administration, an agency under fire over a series of drug safety controversies…"
FDA Promises Action on Painkiller Safety, The San Francisco Chronicle, Feb 16, 2005
"A Merck & Co. official said Wednesday that all painkillers in the same class as the company's Vioxx may cause heart problems or strokes, a change from the drug-maker's earlier position that such health issues appeared limited to its drug…"
Study Links Painkillers to Heart Risk, The San Francisco Chronicle, Feb 15, 2005
"A new study has linked painkillers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs…"
New England Journal of Medicine early releases, published online Feb 15, 2005 (abstracts and extracts freely available)
Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention, S.D. Solomon and Others
Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac Surgery, N.A. Nussmeier and Others
Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial, R.S. Bresalier and Others
COX-2 Inhibitors — A Lesson in Unexpected Problems, J.M. Drazen
COX-2 Inhibitors — Lessons in Drug Safety, B.M. Psaty and C.D. Furberg
Meta-analysis of Cyclooxygenase-2 Inhibitors and Their Effects on Blood Pressure, Aw et al., Archives of Internal Medicine 165, early release Feb 14, 2005 (abstract freely available)
"Cyclooxygenase-2 inhibitors were associated with a point-estimate BP elevation compared with placebo and nonselective NSAIDs…"
Week of February 7, 2005
Patients in Test Won't Get Drug, Amgen Decides, The New York Times, Feb 12, 2005 (free registration required; archived, payment required)
"…The controversy over the drug raises the question of whether drug companies are obligated to continue providing drugs to participants in clinical trials, even after the trials are ended…"
Scientists Say They Often Censor Selves, The San Francisco Chronicle, Feb 11, 2005
"Some scientists are thinking twice about doing or reporting certain research, reacting to political and social controversy in addition to legal restrictions…Formal limits include such things as the ban on federal funding for most research on embryonic stem cells and restrictions on research involving humans…"
HHS Announces Simplified System for Research Protection Assurances, Health and Human Services News Release, Feb 9, 2005
"The U.S. Department of Health and Human Services (HHS) today announced a new simplified mechanism for all research institutions that receive HHS funding or support to obtain an assurance of compliance with HHS regulations for the protection of human subjects. A single Web-based "Federalwide Assurance" (FWA) will replace the several types of assurances under which research institutions had operated in the past….Because of the multiple types of assurances in use, HHS will allow research institutions to transition to the new system over the next 11 months. By Dec. 31, 2005, all institutions conducting HHS-funded human subjects research must hold an FWA approved by HHS' Office for Human Research Protections (OHRP). For more information, visit the OHRP assurance Web page."
US, Scientist Settle Charges in Gene Therapy Death, Reuters, Feb 9, 2005 (no longer available)
"The U.S. scientist who ran a gene therapy study that ended with the death of an 18-year-old is barred from leading human research trials for five years under a settlement with the government, the Justice Department said on Wednesday…"
Reporting of Adverse Events to Institutional Review Boards; Public Hearing, Food and Drug Administration Docket No. 2005N-0038, Federal Register 70: p. 6693-6696, Feb 8, 2005 (meeting on March 21, 2005)
"The Food and Drug Administration (FDA) is announcing a public hearing to consider the process by which institutional review boards (IRBs) obtain and review information on adverse events that occur during the conduct of clinical investigations…The purpose of the hearing is to solicit information and views from interested persons on issues and concerns regarding the submission of adverse events to and their review by IRBs…"
Register for this meeting here. (registration due by Mar 4, 2005)
Submit written or electronic comments here. Click on “Docket Search” in upper left, then enter 2005N-0038 for Docket ID in Docket Search screen. (comments due by Apr 21, 2005)
Canada has a radical plan for social costs of drug use, Seattle Post-Intelligencer, Feb 7, 2005 (scheduled to be available until Feb 13, 2005, still available)
"…Called the North American Opiate Medications Initiative and funded by the federal Canadian Institute of Health Research, the $8 million program will allow health officials in Vancouver, Montreal and Toronto to distribute for free daily doses of heroin to a small, screened group of longtime addicts…the program's aim is to stabilize addicts as a way to stem drug-related crimes and the spread of blood-borne infectious diseases. Eventually, proponents of the study hope, these people can be treated for the addiction…"
Week of January 31, 2005
Abuses Endangered Veterans in Cancer Drug Experiments, The New York Times, Feb 6, 2005 (free registration required; archived, payment required)
"…Veterans Affairs doctors have done pioneering research on spinal cord injuries and schizophrenia and helped develop the cardiac pacemaker. But like universities and private research companies, the department has grappled with allegations of exploiting its human research subjects…"
Human guinea pigs, Queensland Sunday Mail, Australia, Feb 6, 2005 (no longer available)
"…She is not alone. Thousands of Queenslanders are volunteering their time – and their bodies – for medical research and clinical trials…"
Cameroon: Government Suspends Trial of Aids Drug,, Feb 4, 2005 (archived, paid subscription required to access archives)
"Clinical trials of an anti-AIDS drug being tested on sex workers by US pharmaceutical company Gilead have been suspended, the Cameroonian government said on Friday after controversy over how the trials are being conducted…"
NIH-funded research to be available free, The San Francisco Chronicle, Feb 4, 2005
"The National Institutes of Health adopted a new policy Thursday designed to make the results of federally funded medical research available quickly and free to the public…"
NIH Calls on Scientists to Speed Public Release of Research Publications, NIH News, Feb 3, 2005
NIH Guide to Grants and Contracts, Implementation Plan, Questions and Answers fact sheet and additional information on the new policy can be found at NIH’s Public Access Web Page.
Protection for Human Test Subjects, EPA Web Site, Feb 3, 2005
"EPA is developing a policy on the extent to which the Agency will consider or rely on various types of research involving human subjects…In a Federal Register notice to be published soon, the Agency has announced the initiatives it will undertake to evaluate and adopt, as appropriate, the recommendations it received from the National Academy of Sciences (NAS). EPA is seeking public comment on its future plans, which include rulemaking, public engagement, and developing additional policy guidance as needed…"
Environmental Protection Agency Human Testing; Proposed Plan and Description of Review Process, RIN: 2070-AD57 [OPP-2003-0132; FRL-7695-4] (to be published in the Federal Register; 90 day comment period)
Pentagon Boosts Plan For Anthrax Inoculations, The Washington Post, Feb 2, 2005 (free registration required)
"The Pentagon has taken a major step toward reviving its controversial program of giving anthrax vaccine to service members, invoking emergency provisions of the Project BioShield Act that allow use of unapproved drugs and vaccines…"
Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Availability FDA Docket No. Docket No. 2005N-0040, Federal Register Volume 70, Number 21, Pages 5452-5456, Feb 2, 2005 (pdf file)
NIH bans all consulting, The Scientist, Feb 2, 2005
"The National Institutes of Health (NIH) yesterday (February 1) announced a series of "sweeping" new ethics reforms that bar all NIH employees from consulting with or accepting payments from pharmaceutical, biotech, and medical device companies as well as from universities, hospitals, and research institutes that receive NIH funds…"
NIH Announces Sweeping Ethics Reform, NIH News, Feb 1, 2005
NIH Conflict of Interest Information and Resources Web Page
Summary of Regulation, posted Feb 1, 2005 (pdf file)
Regulation: Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services, posted Feb 1, 2005 (public comment opportunity; 96 page pdf file)
Questions and Answers Regarding Regulation, posted Feb 1, 2005 (pdf file)
A Guide to Preventing Conflicts of Interest in Human Subjects Research at NIH, NIH Office of Human Subjects Research Web Site, Jan 4, 2005 (pdf file)
Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior, Dunn and Gordon, Journal of the American Medical Association 293:609-612, Feb 2, 2005 (extract freely available)
"…economic forces operate regardless of how investigators choose to compensate participants. Thus, it is imperative that investigators acknowledge these forces and design compensation schemes that explicitly take economic forces into account…"
Research Compensation and the Monetarization of Medicine, Reiser, Journal of the American Medical Association 293:613-614, Feb 2, 2005 (extract freely available)
"The question of how to foster and reward research participation has 2 basic facets. One involves examining the issue from the perspective of the needs and traditions of research per se. A second facet…is the influence of research compensation decisions on the fabric of medicine itself, particularly when it creates financial exchanges between investigators and participants. This article engages these intertwined matters…"
Pfizer reveals study linking Celebrex to heart risks, The Boston Globe, Feb 1, 2005
"Pfizer Inc. has revealed it completed a study four years ago that links its painkiller Celebrex to a ''statistically significant" increase in heart problems, bolstering demands for speedier dissemination of negative trial results…US Senator Chuck Grassley, an Iowa Republican, this month plans to introduce legislation to prod companies to make clinical trial data public…"
A synopsis of the study referenced in this article has been deposited in, the Pharmaceutical Research and Manufacturers of American (PhRMA) clinical trials database, Pfizer Protocol Number IQ5-97-02-001 (pdf file)
These days, local doctors are also drug researchers, Concord Monitor, Feb 1, 2005
"Clinical trials to test drugs and medical devices have mushroomed in private practices…"
Research ethics 'watchdog' planned in Zambia,, Feb 1, 2005
"Zambia is to set up an independent national committee to monitor the ethics of health research, and to protect the rights, health and safety of participants in clinical trials of potential drugs…"
Drug approval system questioned in US and Canada, Canadian Medical Association Journal, Feb 1, 2005
"As the FDA's drug approval process comes under increasing scrutiny in the US, Health Canada moves closer to beginning concurrent drug reviews with the American regulator…The joint reviews would take place under the terms of a memorandum of understanding that Canada and the United States signed in April 2004 (CMAJ 2004;171:121). The agreement is intended to reduce bureaucratic hurdles for manufacturers applying to have new drugs approved in both jurisdictions, and to bring new drugs to market faster…"
2004 Annual Human Research Protection Award Recipients Announced, U.S. Newswire Press Release, Jan 31, 2005
"Barbara F. Mishkin received the 2004 Life-time Achievement Award for Excellence in Human Research Protection… Dr. Robert J. Levine received an Award for Excellence in Human Research Protection for Lifetime Achievement… Awards for Excellence in Human Research Protection for Innovation: Dana-Farber Cancer Institute, Christina M. Parker, M.D, audiovisual program "Entering a Clinical Trial: Is it Right for You?"; Washington University Medical Center, Human Studies Committee, Dr. Philip Ludbrook and Dr. John Csernansky - The Guidelines for the Evaluation of Studies in Persons with Psychiatric Illnesses…"
Week of January 24, 2005
Eli Lilly: Correction and apology, The British Medical Journal, Jan 29, 2005
"…As a result of the investigation, it is clear that these documents did not go missing…"
Africa and Europe create ethics network,, Jan 28, 2005
"An initiative intended to raise the role of ethics in medical research conducted in Africa was launched yesterday (27 January) in Paris. The programme, called Networking for Ethics on Biomedical Research in Africa (NEBRA), was created to understand ethical issues arising in individual African countries, and to identify people already involved in reviewing ethics of research and identify their needs…"
Cameroon: Clinical Trial of Anti-HIV Drug On Sex Workers in Question,, Jan 27, 2005 (archived; paid subscription required to access archives)
"The government of Cameroon has said it may stop the clinical trial of an anti-AIDS drug being tested on 400 sex workers in the port city of Douala following allegations that the women are receiving inadequate counselling and medical care…"
Safety whistleblower recommended for bonus, Seattle Post-Intelligencer, Jan 26, 2005 (no longer available)
"A government scientist who blew the whistle on shoddy research had been recommended for a cash bonus, but his bosses pulled it back and tried to fire him after the scientist raised allegations of interference with his safety work, memos show…"
Patient Care vs. Corporate Connections, The New York Times, Jan 25, 2005 (free registration required; archived, payment required)
"…The Cleveland Clinic, one of the most entrepreneurial and prestigious medical institutions in the country, for one, is struggling to revamp rules intended to ensure that corporate connections do not lead to bias in patient care or academic research. But it is far from willing to sever all ties…"
Vioxx, Celebrex overpromoted, study says, The San Francisco Chronicle, Jan 25, 2005
"…The new study, published in the journal Archives of Internal Medicine, was initiated to investigate whether the increased cost of the COX-2 drugs produced a greater benefit for patients…But the author's conclusion -- that millions of patients and health plans were paying significantly more money for drugs that gave little or no benefit -- has been overshadowed by the safety concerns…another article, released Monday in the Lancet medical journal, [written by FDA whistle-blower David Graham] which estimated that Vioxx had caused 88,000 to 140, 000 additional cases of serious heart disease during its almost five years on the market…"
The articles referenced in this news report are:
National Trends in Cyclooxygenase-2 Inhibitor Use Since Market Release, Dai, Stafford, and Alexander, Archives of Internal Medicine165:171-177, Jan 24, 2005 (abstract freely available)
Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study, Graham et al, The Lancet 365, Jan 22, 2005 (free registration required; extract freely available)
Stem-cell research lines reported tainted, The Seattle Times, Jan 24, 2005
"All human embryonic stem-cell lines approved for use in federally funded research are contaminated with a foreign molecule from mice that may make them risky for use in medical therapies, according to a study released yesterday…"
Human embryonic stem cells express and immunogenic nonhuman sialic acid, Martin et al, Nature Medicine, Jan 26, 2005 (no longer available)
Ambulatory Pediatric Association Policy Statement: Ensuring Integrity for Research With Children, Ambulatory Pediatrics 5: 3-5, Jan-Feb 2005 (pdf file)
"…To help manage and eliminate conflicts of interest and to regain public trust, the Ambulatory Pediatric Association developed a code of ethics for research in general pediatrics…"
Week of January 17, 2005
Johnson & Johnson reports Reminyl deaths, The Boston Globe, Jan 21, 2005 (no longer available)
"Patients taking Alzheimer's drug Reminyl in a test for another use had higher death rates than those taking a placebo, Johnson & Johnson Pharmaceutical Research & Development LLC announced Friday…"
Plan postpones public access to research, The Boston Globe, Jan 19, 2005
"An ambitious proposal to make the results of federally funded medical research available to the public quickly and for free has been scaled back by the National Institutes of Health under pressure from scientific publishers, who argued that it would cut their profits and harm the scientific enterprise they support…"
US Warns of Safety Risks of Boehringer AIDS Drug, Reuters, Jan 19, 2005 (no longer available)
"An important AIDS drug can cause sometimes deadly liver damage but remains a key option for many patients, U.S. health officials warned on Wednesday.  The Food and Drug Administration said doctors should weigh benefits and risks before prescribing…nevirapine…"
FDA Public Health Advisory for Nevirapine (Viramune), Jan 19, 2005
Ex-researcher pleads guilty to homicide, Seattle Post-Intelligencer, Jan 18, 2005 (no longer available)
"A former cancer researcher pleaded guilty Tuesday to criminally negligent homicide in the death of a patient enrolled in a clinical trial at an upstate New York veterans' hospital…"
Dying doctor's noble choice. Stricken S.F. neurologist enters own 'placebo' trial, The San Francisco Chronicle, Jan 17, 2005
"…he hopes his role as a test subject will highlight the value of placebo-controlled drug trials, which must be "double blinded" so that neither the patients nor the trial investigators know which pills are real and which are fake…Even some who understand the significance of controlling for the placebo effect argue that standard, slow-moving drug tests ask a lot of ALS patients…"
Dispute Puts a Medical Journal Under Fire, New York Times, Jan 17, 2005 (free registration required; archived, payment required)
"Last year was an especially bad one for the pharmaceutical industry, which experienced controversies over how drug studies are disclosed and the implosion of the painkiller Vioxx. Now, as a result of the recent publication of an article about the antidepressant Prozac, it appears that the staid, usually methodical world of medical journals could suffer its own black eye…"
Week of January 10, 2005
Office for Human Research Protections (OHRP) Announcement, Jan 8, 2004
OHRP announces the enhancement of their web-based electronic submission system (ESS) for use in submitting Federalwide Assurances (FWA) and Institutional Review Board/Independent Ethics Committee (IRB/IEC) registrations. Effective Monday, January 3, 2005, ALL institutions holding an OHRP-approved FWA and ALL organizations with a registered IRB/IEC(s) may use the ESS to submit updates/renewals. OHRP’s ESS is found at:
American Psychologist Special Issue Devoted to Genes, Race, and Psychology in the Genome Era, American Psychological Association Press Release, January 16, 2005 (first article and summary of 10 articles is freely available)
"In a series of articles, leading researchers discuss racial health disparities and the controversial area of intelligence, while also carefully outlining specific instances and ways in which researchers should measure or use race. According to the authors, such research requires a careful examination of both environmental and genetic factors, as well as conceptually sound and methodologically rigorous measures of race at a level not yet universal in all research. The special issue also looks at the construct of race in the 21st century, as well as the historical use of the construct in science…"
Genes, Race and Psychology in the Genome Era, Anderson and Nickerson, American Psychologist 60: pp. 5-8, Jan 2005 (first article in series freely available; pdf file)
NC rule puts Duke blood substitute study on hold, Winston-Salem Journal, Jan 12, 2005
"Duke University has put off study of a potentially lifesaving blood substitute for trauma victims while it examines a state law that requires patient consent for clinical trials, officials said Wednesday…"
Africa: Nevirapine - Lifesaver Or Harmful Drug?,, Jan 12, 2005 (archived; paid subscription required to access archives)
"The antiretroviral drug, Nevirapine, commonly used in Africa to prevent transmission of HIV from mother to child, is at the centre of a bitter controversy…"
The Ethics of Research Using Biobanks: Reason to Question the Importance Attributed to Informed Consent, Hoeyer et al. Archives of Internal Medicine 165: 97-100, Jan 10, 2005 (abstract freely available)
"Conclusions: Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research…"
Feds failed to disclose financial interest, Monterey County Herald, Jan 10, 2005 (no longer available)
"Government scientists have collected millions of dollars in royalties for experimental treatments without having to tell patients testing the treatments that the researchers' had a financial connection, according to documents and interviews…"
Drug firms lagging on openness, The Boston Globe, Jan 9, 2005
"Six months after the drug industry vowed to make its clinical trials more transparent, and three months after launching a common website to give the public ''unprecedented access" to studies both good and bad, drug companies have posted unpublished trial results on the site for just five drugs…"
The ethics of human testing may be decided case by case, Houston Chronicle, Jan 8, 2005 (no longer available)
"In setting limits on chemicals in food and water, the Environmental Protection Agency may rely on industry tests that expose people to poisons and raise ethical questions…"
Recent developments in gene transfer: risk and ethics, Kimmelman, British Medical Journal 330:79-82, Jan 8, 2005 (extract freely available)
"…In this article I review several matters relating to human gene transfer—safety features that distinguish traditional drugs from agents used to transfer genes, ethical issues raised by uncertainties about risk and toxicological properties, and studies on safety…"
Indian researchers accused of violating ethical guidelines, British Medical Journal, Jan 8, 2005 (extract freely available)
"Medical experts in India have accused government doctors of violating national guidelines on clinical ethics by treating patients in Mumbai with a new and unproved treatment developed abroad without insisting on parallel studies outside India…"
Need for expertise based randomised controlled trials, Devereaux et al. British Medical Journal 330: January 8, 2005 (extract freely available)
"…An alternative trial design, the expertise based randomised controlled trial, randomises participants to clinicians with expertise in intervention A or clinicians with expertise in intervention B, and the clinicians perform only the procedure they are expert in. We present evidence to support our argument that increased use of the expertise based design will enhance the validity, applicability, feasibility, and ethical integrity of randomised controlled trials in surgery, as well as in other areas…"
Week of January 3, 2005
More transparency offered in drug trials, The Boston Globe, Jan 6, 2005 (no longer available)
"The embattled pharmaceutical industry announced its intention Thursday to publish more data about clinical drug trials, despite skepticism about whether the initiative will really increase transparency and improve drug safety…"
Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Database, Jan 6, 2005 (pdf file)
NIH whistleblower says government bungled AIDS study in Uganda, The Boston Globe, Jan 4, 2005 (no longer available)
"Federal officials involved in a U.S.-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices, a government whistleblower said Tuesday…"
FDA gives scientist permission to publish Vioxx safety data, The San Francisco Chronicle, Jan 4, 2005
"The Food and Drug Administration has given a whistle-blower scientist permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said Monday…"
Journal Tells FDA Lilly Knew of Prozac Risk, Reuters, Dec 31, 2004 (no longer available)
"The British Medical Journal said on Friday it has sent documents to U.S. health regulators that appear to suggest a link between the antidepressant Prozac and suicidal behavior. In its Jan. 1 issue, the journal said an anonymous source had provided "missing documents" that included reviews and memos appearing to show that officials at Eli Lilly and Co., the drug's maker, knew in the 1980s that it had "troubling side effects"…"
FDA to review "missing" drug company documents, British Medical Journal, Jan 1, 2005 (extract freely available)
Lilly Affirms: No 'Missing' Prozac Documents and No New Scientific Information, Lilly News, Jan 4, 2005
Link to Lilly Documents, posted by CNN, Jan 3, 2005 (pdf file)
Week of December 27, 2004
NIH Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens, Notice Number: NOT-OD-05-020, Release Date: December 30, 2004
This Notice explains changes that NIH has made to grant application and contract proposal instructions to reflect the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, issued Aug 10, 2004 (pdf file)
Rofecoxib, Merck, and the FDA, The New England Journal of Medicine 351:2875-2878, Dec 30, 2004 (Letters to the Editor, including Merck and FDA responses; full text freely available)
Cardiologist calls for more FDA power, The Seattle Post-Intelligencer, Dec 29, 2004 (no longer available)
"The controversy over pain relievers' cardiovascular risks highlights the need to empower the U.S. Food and Drug Administration to demand drug companies conduct further tests on already-approved drugs, according to a prominent cardiologist…"
Arthritis Medicines and Cardiovascular Events--"House of Coxibs", Topol, Journal of the American Medical Association 293:366-368, Jan 19, 2005 (extract freely available)
Family files lawsuit in case of woman killed by experimental AIDS drug regimen, San Diego Union-Tribune, Dec 29, 2004
"The family of a pregnant woman who died while taking experimental AIDS drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million…"
Ecstasy to be tested on cancer patients, The Seattle Times, Dec 28, 2004
"…This month, in a little-noted administrative decision, the Food and Drug Administration gave the green light to a Harvard proposal to test the benefits of the illegal street drug Ecstasy in patients diagnosed with severe anxiety related to advanced cancer. The study will look at whether the drug can help terminally ill patients lessen their fears, quell thoughts of suicide and make it easier for them to deal with loved ones…"
Fear about painkillers hobbles key research, The Seattle Times, Dec 27, 2004
"The spate of bad news about painkillers has dealt a major setback to what had been a highly promising effort to use the drugs to prevent a host of leading killers, including many types of cancer, Alzheimer's and other forms of dementia…"
A study of warning letters issued to institutional review boards by the US Food and Drug Administration, Bramstedt and Kassimatis, Clinical and Investigative Medicine 27: 316-323, December 2004 (abstract and full article freely available)
"Conclusions: …The content of these letters consistently indicates weaknesses in review and documentation activities of audited IRBs, potentially signalling similar issues among IRBs across the United States…"
Week of December 20, 2004
HOT STORIES OF 2004, 2005 STORIES TO WATCH: Concerns over safety undermine FDA, The San Francisco Chronicle, Dec 26, 2004
"The FDA, considered the gold standard in drug safety review, lost its luster in 2004 after a string of high-profile drug controversies. The growing crisis of confidence could lead to reforms at the FDA and stricter rules on pharmaceutical firms in 2005…"
FDA to review studies of Celebrex and Bextra, The Seattle Times, Dec 24, 2004
"Federal regulators yesterday ordered reviews of dozens of ongoing patient studies of the prescription painkillers Celebrex and Bextra in light of recent findings that both drugs may increase the risk of heart attack and stroke…"
FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors, FDA Talk Paper, Dec 23, 2004
FDA Public Health Advisory Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS), Dec 23, 2004
Drug makers revamping clinical-trial system, The Boston Globe, Dec 21, 2004
" …In the most widely adopted move, drug companies are combining their earliest safety and dosing tests in humans with an examination of the drug's effectiveness.  Manufacturers also want to use ''biomarkers" instead of patient health to determine whether a compound works in the body. And they are beginning to use genetic profiles to select clinical trial subjects who are most likely to respond favorably…"
Articles about AIDS drug trial prompt outrage in Africa, The San Francisco Chronicle, Dec 21, 2004
" A series of articles critical of past trials of an important AIDS drug has created a furor in Africa, causing many public health experts to worry that some countries will stop using the drug, which prevents mothers from infecting their babies with the virus that causes AIDS…"
National Institute of Allergy and Infectious Diseases (NIAID) Questions and Answers The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV, NIAID Newsroom, Dec 17, 2004
National Institute of Allergy and Infectious Diseases (NIAID) Statement The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV, NIAID Newsroom, Dec 14, 2004
Painkiller Aleve faces questions on safety, The Seattle Times, Dec 21, 2004
" The epidemic of bad news about the potential risks of popular anti-inflammatory medications expanded yesterday as federal officials said that naproxen, a painkiller sold by prescription and also over the counter as Aleve, might increase people's risk of heart attack or stroke…"
Use of Non-Steroidal Anti-Inflammatory Drugs Suspended in Large Alzheimer’s Disease Prevention Trial, NIH News, Dec 20, 2004
FDA Statement on Naproxen, Dec 20, 2004
Pursuing the placebo effect: What exactly is it?, American Medical News, Dec 20, 2004
" The placebo-controlled trial long has been the standard-bearer that provides the comparison point by which a medical intervention, particularly a drug, can be deemed to work or not. Increasingly, though, researchers are considering the value of placebo on an entirely different level, asking whether something can be learned from the fact that beneficial effects are sometimes seen in subjects taking dummy pills and if this occurrence can somehow be translated into improved medical care…"
Pfizer pulling advertising for Celebrex, The Boston Globe, Dec 20, 2004
"The maker of best-selling arthritis pain reliever Celebrex said it plans to immediately stop advertising the drug. The move comes after a study showed high doses of Celebrex were associated with an increased heart attack risk…"
Week of December 13, 2004
Pfizer: Celebrex raises heart attack risk, The Boston Globe, Dec 18, 2004
"Pfizer Inc. said it found an increased risk of heart attacks and strokes for patients taking high dosages of its top-selling arthritis painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx…"
NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial, NIH News, Dec 17, 2004
FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex, FDA News, Dec 17, 2004
Pfizer Statement on New Information Regarding Cardiovascular Safety of Celebrex, Pfizer Press Release, Dec 17, 2004
Funding Availability: Ethics Education in Science and Engineering (EESE), National Science Foundation Program Solicitation NSF 05-532 (posted Dec 9, 2004; Full Proposal Deadline: March 10, 2005)
Flawed Device Places F.D.A. Under Scrutiny, The New York Times, Dec 15, 2004 (free registration required; scheduled to be freely available until Dec 21, 2004; still available)
"…Already under scrutiny for what some critics say is lax oversight of prescription drugs, the F.D.A. may have similar fault lines in its medical devices unit…"
Health Minister Ujjal Dosanjh Reaffirms Commitment to Transparency of Clinical Trials, Government of Canada Newsroom, Dec 14, 2004
"…today released Health Canada’s 2003-2004 Summary Report of inspections of clinical trials. The objectives of the report are to ensure the well-being of Canadians involved in clinical trials, while also educating scientific and research ethics communities and the public, on their roles and responsibilities in the conduct of clinical trials in Canada…"
Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004, Health Products and Food Branch, Health Canada, Dec 14, 2004
AP News Stories on NIH Nevirapine Studies
AP Exclusive: Woman died during gov’t AIDS study, Boston Globe, Dec 16, 2004
"A pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say…"
Documents gathered by AP for “death during gov’t AIDS study” story (all are pdf files)
Includes: internal NIH emails regarding subject death, study site visit report, protocol amendment letter regarding liver toxicity management, study consent form
NIH was warned in '02 on AIDS drug for Africa, Boston Globe,  Dec 14, 2004
"Weeks before President Bush announced a plan to protect African babies from AIDS, top US health officials were warned that research in Uganda on the key drug was flawed and may have underreported severe reactions, including deaths, government documents show…But the NIH, the government's premier health research agency, chose not to inform the White House as it scrambled to keep its specialists' concerns from scuttling the use of nevirapine in Africa as a less expensive solution…"
AP Exclusive: AIDS research chief rewrote safety report, ordered clinic opened over objections, The San Francisco Chronicle, Dec 14, 2004
"The government's chief of AIDS research rewrote a safety report on a U.S.-funded drug study to change its conclusions and delete negative information. Later, he ordered the research resumed over the objections of his staff, documents show…"
Excerpts of original AIDS drug report, Seattle Post Intelligencer, Dec 14, 2004 (no longer available)
"Excerpts showing key differences between an original safety report written by the National Institutes of Health's Dr. Betsy Smith concerning research on the AIDS drug nevirapine and the rewritten version of the report by AIDS research chief Dr. Edmund Tramont…"
Documents gathered by AP for the NIH-Uganda nevirapine story (all are pdf files)
Includes: OHRP compliance oversight determination letter, Westat audit of Uganda site, internal NIH meeting minutes, Tramont summary of Westat audit, Boehringer Ingelheim report on Uganda research
Drug expert seeks whistleblower status, Seattle Post Intelligencer, Dec 13, 2004 (no longer available)
"The expert hired by the National Institutes of Health last year to improve its research practices after problems in an AIDS drug study surfaced is seeking whistleblower protection after disagreements with management have left him on the verge of being fired…"
Week of December 6, 2004
Grassley to Introduce Bill To Require Database of Clinical Trial Results, Medical News Today, Dec 10, 2004 (no longer available)
"Senator Chuck Grassley (R-Iowa) plans to introduce legislation in early 2005 that would require pharmaceutical companies to register drug trials and report findings in a public database, a Grassley aide said Thursday…"
Eli Lilly Launches Online Clinical Trial Registry, Reuters, Dec 8, 2004 (no longer available)
"Drugmaker Eli Lilly and Co. on Wednesday said it will make clinical trial information available online amid calls by lawmakers and physicians for more disclosure of negative trial results. Lilly said the registry would include results from all Phase I through Phase IV clinical trials of its marketed products…"
Eli Lilly and Company Clinical Trials Registry
Dispute on medical record access settled. Cancer researchers wanted UC data on new cases quicker, The San Francisco Chronicle, Dec 7, 2004
"A federal rule protecting the privacy of medical charts will no longer be used by the University of California to block the timely access to data on newly diagnosed cancer cases, according to an agreement between the university and the state Department of Health Services…"
At F.D.A., Strong Drug Ties and Less Monitoring, The New York Times, Dec 6, 2004 (free registration required; archived, payment required)
"…Dozens of former and current F.D.A. officials, outside scientists and advocates for patients say the agency's efforts to monitor the ill effects of drugs that are on the market are a shadow of what they should be because the White House and Congress forced a marriage between the agency and industry years ago for the rich dowry that industry offered…"
Wash center to study child medical ethics, Seattle Post-Intelligencer, Dec 6, 2004 (no longer available)
"Children's Hospital is establishing a new center to examine ethics issues that arise in the care of children. The Center for Pediatric Bioethics, the first of its kind, will receive $340,000 a year in federal funds plus $1 million in startup money from Children's Hospital and Regional Medical Center, which is affiliated with the University of Washington…"
Center for Pediatric Bioethics to be Established in Seattle, Children’s Hospital and Regional Medical Center Press Release, Dec 6, 2004
Medical research 'stifled by rules', Guardian, UK, Dec 6, 2004
"A "catastrophic" increase in bureaucracy from new European regulations has slowed the pace of medical research in the UK and will make academics reliant on funding from the pharmaceutical industry, researchers have warned…"
Blood product trial sparks informed consent debate, American Medical News, Dec 6, 2004
"A test for a new blood substitute has created tension between groups seeking to save lives and those looking to preserve research ethics…"
Week of November 29, 2004
Funding Availability: Community Participation in Research, PA Number PAR-05-026, Participating Agencies: NIH, AHRQ, CDC, Announced Dec 2, 2004
"…The ultimate goal of this PAR is to support research on health promotion, disease prevention, and health disparities that is jointly conducted by communities and researchers.  This PAR invites NIH research project grant (R01) and exploratory/developmental grant (R21) award mechanisms…"
Letters of Intent Receipt Date(s): April 17, 2005, 2006, 2007
Application Receipt Date(s): May 17, 2005, 2006, 2007
Influence of Ethical Safeguards on Research Participation: Comparison of Perspectives of People With Schizophrenia and Psychiatrists Roberts et al. American Journal of Psychiatry 161:2309-2311, December 2004 (abstract freely available)
"CONCLUSIONS: Ethical commitment to research volunteers is expressed in safeguards. These efforts appear to be viewed positively by key stakeholders and may influence research participation decision making."
AP: EPA looking at using tests on people, Seattle Post Intelligencer, Nov 30, 2004 (no longer available)
"In setting limits on chemicals in food and water, the Environmental Protection Agency may rely on industry tests that expose people to poisons and raise ethical questions…"
Human Testing of Pesticides: Ethical and Scientific Considerations, Lockwood, American Journal of Public Health, Vol 94: 1908-1916, November 2004 (abstract freely available)
"I reviewed ethical and scientific aspects of 6 human pesticide-dosing studies submitted to the Environmental Protection Agency (EPA) for consideration during the pesticide reregistration process. All had serious ethical or scientific deficiencies—or both—including unacceptable informed consent procedures, unmanaged financial conflicts of interest, inadequate statistical power, inappropriate test methods and endpoints, and distorted results…"
Contracts Keep Drug Research Out of Reach, The New York Times, Nov 29, 2004 (free registration required; archived, payment required)
"…Academic institutions and researchers are widely viewed as the impartial, independent heart of the system this country uses to test drugs and medical devices…Critics say, however, that academic institutions and their researchers need to examine their own practices because they share part of the blame…The problem starts with the terms of the contracts that some universities sign for clinical trials, but of equal importance is how researchers choose to describe study results and even whether they pursue publication…"
Week of November 22, 2004
Advisory group to review NHS research ethics committees, British Medical Journal 329, Nov 27, 2004 (abstract freely available)
"The UK government has appointed an advisory group to review the operation of research ethics committees controlling research in the NHS in England, with the aim of streamlining procedures…"
Government reviewing when Bayer revealed risks with yanked drug, The San Francisco Chronicle, Nov 26, 2004
"In a move that could lead to a criminal investigation, the government is checking its records to determine if drug maker Bayer AG was forthcoming about safety concerns with its cholesterol-lowering Baycol drug that surfaced within months of it hitting the market…"
Safety critic says he faces FDA transfer in "reprisal", The Seattle Times, Nov 25, 2004
"Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency's approach to drug safety during a congressional hearing last week, said yesterday that he was facing pressure to transfer to a different job in the FDA — a move that he said was in retaliation for his remarks…"
Ownership and Use of Tissue Specimens for Research, Hakimian and Korn, Journal of the American Medical Association 292:2500-2505, Nov 24, 2004 (abstract freely available)
"This article examines the legal, regulatory, and ethical framework within which human tissue research is currently conducted…"
War II vets' valor ends in pain, broken promises, Monterey County Herald, Nov 23, 2004
"On the morning of March 10, 1993, as a blizzard barreled toward the East Coast, two senior officials from the Department of Veterans Affairs sat before a congressional panel and explained how the VA planned to track down thousands of World War II veterans exposed to hazardous chemicals…"
Dangerous testing went beyond vets to orphans, prisoners, Monterey County Herald, Nov 23, 2004
Medical journal faults FDA's work, The Seattle Times, Nov 23, 2004
"Drug maker Bayer was slow to report the risks of its cholesterol-lowering drug Baycol and to remove it from the market in 2001, according to an upcoming report in the Journal of the American Medical Association (JAMA). The findings, based in part on internal company documents revealed in a recent court case, raise new questions about the Food and Drug Administration's effectiveness in monitoring the safety of drugs after it has approved them for sale…."
The JAMA articles referenced in this news article are available as follows:
Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis. Psaty et al., Journal of the American Medical Association, early release, published online Nov 22, 2004 (paid subscription now required for access)
Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: A Counterpoint. Strom, Journal of the American Medical Association, early release, published online Nov 22, 2004 (paid subscription now required for access)
Postmarketing Surveillance--Lack of Vigilance, Lack of Trust, Fontanarosa et al., Journal of the American Medical Association, early release, published online Nov 22, 2004 (paid subscription now required for access)
Bayer's Response to "Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis", Piorkowski, Journal of the American Medical Association, early release, published online Nov 22, 2004 (paid subscription now required for access)
Authors' Reply to Bayer's Response to "Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis", Psaty et al., Journal of the American Medical Association, early release, published online Nov 22, 2004 (paid subscription now required for access)
Canadian drug regulatory process criticized, CTV, Nov 23, 2004
"Health Canada's attempt at responding to criticisms that the country's drug regulatory process protects pharmaceutical companies at the possible expense of consumers doesn't go far enough to fix the problem, a pair of veteran researchers say…"
Transparency in drug regulation: Mirage or oasis? Lexchin and Mintzes, Canadian Medical Association Journal 171, Nov 23, 2004 (full article freely available)
Drug trial – and error? New York Newsday, Nov 22, 2004 (no longer available)
"…Suthers was one of 34 patients in a study to determine whether the medicine, a growth factor critical to brain health, would delay or stop the brain cell death associated with Parkinson's…Doctors involved in the trials said they have seen no harmful signs among the patients, many of whom reported dramatic improvement. Now patients are writing letters to company officials begging to have access to the medicine. And many of the doctors are urging the company to redesign the study and make the drug available to the participants…
Week of November 15, 2004
US-Led Push for Broad UN Cloning Ban Crumbles, Reuters, Nov 19, 2004 (no longer available)
"A divided United Nations on Friday rejected a U.S.-led campaign to ban all cloning of human embryos, including for stem-cell research, as a General Assembly committee opted instead for a nonbinding declaration…"
5 widely used drugs called unsafe, The San Francisco Chronicle, Nov 19, 2004
"A veteran Food and Drug Administration safety officer Thursday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects…"
List of Congressional Hearing Statements is available here.
To go directly to individual statements, click on the following names (all are pdf files):
Charles Grassley, IA
Max Baucus, MT
Dr. David J. Graham FDA
Dr. Gurkirpal Singh Stanford University
Dr. Bruce M. Psaty University of Washington
Dr. Sandra L. Kweder FDA
Mr. Raymond V. Gilmartin Merck
Statement by Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER), regarding November 18, 2004, Committee on Finance of the U.S. Senate hearing on drug safety and the worldwide withdrawal by Merck & Co., Inc., of Vioxx, FDA News, Nov 18, 2004
"Dr. Graham's congressional testimony does not reflect the views of the Agency…"
FDA Statement on Vioxx and Recent Allegations and the Agency’s Continued Commitment to Sound Science and Peer Review, FDA News, Nov 17, 2004
"The Food and Drug Administration today released the following statement by Acting Commissioner Dr. Lester M. Crawford: …I am issuing this statement to further clarify the Agency's activities in…
  • Issues involving allegations about the performance of FDA's Office of Drug Safety;
  • Allegations about a scientific paper submitted to the British medical journal, The Lancet;
  • The possible participation of Dr. Curt Furberg in an upcoming FDA advisory committee to discuss Cox-2 inhibitors; and
  • Further information about FDA's recent announcements to strengthen its safety program for marketed drugs."
UN cloning vote likely this week, The Scientist, Nov 17, 2004
"The legal committee of the United Nations' General Assembly is likely to take some kind of action on Friday (November 19) on the issue of whether to ban both reproductive and therapeutic cloning or to ban reproductive cloning and allow individual states to decide whether they want to permit therapeutic cloning research, despite the fact that recent negotiations have not resolved the deep divide in the committee…"
HHS Observes 25th Anniversary of Belmont Report for Human Research Subject Protections, HHS News Release, Nov 16, 2004
"HHS today marked the 25th anniversary of the Belmont Report that articulated the founding principles for federal human research subject protections, with the release of an oral-history video about the report and a ceremony to honor the report's authors…Prior to the report, researchers independently decided what was studied and how studies were conducted. Now however, the system provides protections, including ethical review by committees independent from the research…This educational video is the first in a series of oral history-based training materials that HHS will release over the next year…"
Report slams UBC ethics, The Scientist, Nov 15, 2004
"The University of British Columbia (UBC) had "indefensible" deficiencies with reviews of 523 research projects approved before mid 2001 by an "overwhelmed" and underfunded ethics panel that resulted in the university "more or less" allowing investigators "to do their own ethics review," according to a review made partially available last week. Such problems with oversight, two ethics experts said, are likely widespread right across the country…"
UK Jury Rules Nerve Gas Death Was Unlawful Killing, Reuters, Nov 15, 2004 (no longer available)
"British military chiefs unlawfully killed a serviceman 51 years ago during secret experiments into the effect of deadly nerve agents, an inquest ruled on Monday…"
Week of November 08, 2004
36% of cancer patients ages 65 and older participate in clinical trials,, Nov 14, 2004
"A new study finds that only 36% of cancer patients ages 65 and older participate in clinical trials, despite making up 60% of the U.S. cancer population…Researchers performed a retrospective analysis of 28,766 people participating in 55 clinical trials of new cancer drugs or new indications of already approved cancer drugs from 1995 to 2002…"
Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration, Talarico et al. Journal of Clinical Oncology 22: 4626-4631, Nov 15, 2004 (abstract freely available)
Increasing Access to Clinical Cancer Trials and Emerging Technologies for Minority Populations: The Native American Project. Petereit et al. Journal of Clinical Oncology 22: 4452-4455, Nov 15, 2004 (full article available)
Despite Warnings, Drug Giant Took Long Path to Vioxx Recall, The New York Times, Nov 14, 2004 (free registration required; archived, payment required)
"…a detailed reconstruction of Merck's handling of Vioxx, based on interviews and internal company documents, suggests that actions the company took - and did not take - soon after the drug's safety was questioned may have affected the health of potentially thousands of patients, as well as the company's financial health and reputation…"
Experts to meet in February to discuss arthritis drug risks, The San Francisco Chronicle, Nov 12, 2004
"A federal drug safety adviser said Friday the government rescinded his invitation to participate in a February meeting on the risk of Vioxx and other arthritis drugs because he had already publicly expressed doubts about the medications…"
Pesticide study using children as test subjects postponed, The San Diego Union-Tribune, Nov 10, 2004
"A planned government study into how children's bodies absorb pesticides and other chemicals has been temporarily suspended due to ethical concerns…"
New drug for heart endorsed for blacks, The Seattle Times, Nov 9, 2004
"A new heart drug targeted exclusively at blacks reduced deaths from advanced heart failure by 43 percent and reduced hospitalizations by a third, setting the stage for it to become the first drug approved for only one race…"It's great that this is showing such promise to treat heart failure," said ethicist Jonathan Kahn of Hamline University in Minnesota. "But it is extremely unfortunate that the packaging has been associated with race…The patients happened to be black, but you can't make any claims based on the data."…"
Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure, Taylor et al. New England Journal of Medicine published online Nov 8, 2004 (abstract freely available)
Merck faces more inquiries over Vioxx research, The San Francisco Chronicle, Nov 9, 2004
"Federal prosecutors and the Securities and Exchange Commission are investigating Merck & Co. in connection with Vioxx, the painkiller that was pulled from the market in late September because it increased the risk of heart attacks in long-term users…"
Hundreds used as 'drug guinea pigs', BBC News, UK, Nov 8, 2004
"The health of hundreds of UK patients is at risk because their GPs are secretly being paid to use them as guinea pigs in drug trials, an investigator has told the BBC…"
Green Light for Medical Devices 'Far Too Easy to Get',, Nov 8, 2004 (archived; paid subscription required to access archives)
"It is surprisingly easy for a company to get a medical device onto the South African market. In stark contrast to makers of medicines, businesses selling artificial limbs, contraceptive implants, or breast inserts face few regulatory hurdles…"
Week of November 01, 2004
Health-care worker sentenced for ID theft, The Seattle Times, Nov 6, 2004
"Calling the crime one of the "most deplorable I've witnessed in 15 years on the bench," U.S. District Judge Ricardo S. Martinez sentenced a local health-care worker yesterday to 16 months in prison for stealing the identity of a cancer patient and running up credit-card bills in his name. It was the first prosecution nationally under the Health Insurance Portability and Accountability Act (HIPAA), which became effective in April 2003…"
FDA to boost safety reviews. In-house warnings after drug releases went unheeded, critics say, The San Francisco Chronicle, Nov 6, 2004
"The Food and Drug Administration -- reacting to claims that it lets dangerous drugs stay on the market despite warnings from its own scientists -- said Thursday it will bolster its safety oversight division. The action came as a prestigious medical journal accused the FDA of tolerating "lethal weaknesses" in its method of tracking serious side effects that can surface as newly approved drugs move into wider use…"
FDA Acts to Strengthen the Safety Program for Marketed Drugs, FDA News, Nov 5, 2004
"FDA has announced a series of steps aimed at strengthening the agency's program for evaluating the safety of marketed drugs…"
Vioxx, the implosion of Merck, and aftershocks at the FDA, Horton, The Lancet 364, published online Nov 5, 2004 (free registration required, full article freely available)
Risk of cardiovascular events and rofecoxib: cumulative meta-analysis, Juni et al. The Lancet 364, published online Nov 5, 2005 (free registration required, full article freely available)
Users' guide to detecting misleading claims in clinical research reports, Montori et al. British Medical Journal 329:1093-1096, November 6, 2004 (abstract freely available)
"Plenty of advice is available to help readers identify studies with weak methods, but would you be able to identify misleading claims in a report of a well conducted study?…"
Global spending on health research still skewed towards wealthy nations, British Medical Journal, Nov 6, 2004 (abstract freely available)
"Despite the tripling of the global spend on health research over the past decade, most research and development spending is still done by, for, and in countries with high income, a new report from the Global Forum for Health Research has found…"
Monitoring global health: time for new solutions, Murray et al. British Medical Journal 329:1096-1100, Nov 6, 2004 (abstract freely available)
FDA Proposed Medication Guide: About Using Antidepressants in Children or Teenagers, FDA Website, Nov 3, 2004
"The FDA has written a proposed Medication Guide about Using Antidepressants in Children or Teenagers and sent this Medication Guide to all the sponsors on October 21, 2004. It appears here to inform other groups and individuals with an interest in this Medication Guide. The FDA hopes to finalize the language of this Medication Guide by December 2004 so that the Medication Guide can be produced and made available to patients by the end of January 2005…"
Translation frustration: When research doesn't reach, American Medical News, Nov 1, 2004
"When John P.A. Ioannidis, MD, researched what happened to more than 100 major scientific discoveries published 20 to 25 years ago in the most significant scientific journals, he didn't find much…While he notes that some of these innovations should never reach patients anyway, he is one of many who voice concern about the slow, bumpy and sometimes impassable road that scientific discoveries travel from the test tube to the clinical trial setting and finally to real-world medical practice…"
Proposition 71. A new era for stem-cell study, The San Francisco Chronicle, Nov 4, 2004
"…The initiative was designed as an end run around the Bush administration, which enacted a policy in 2001 barring NIH grants for any stem cell work involving destruction of human embryos. Now California has jumped in with an alternative source of grants -- up to $350 million a year for a decade…Grants will be administered by a newly created California Institute for Regenerative Medicine. Within the next 40 days, as specified in the proposition, state officials and UC chancellors are expected to name a 29- member committee to oversee the institute…"
Patient deaths decline in cancer drug studies, The Boston Globe, Nov 2, 2004
"Patient deaths from experimental cancer drugs during initial human studies declined dramatically from 1991 to 2002, suggesting that better oversight and less-toxic medicines have made cancer research safer, a study found…"
Trends in the Risks and Benefits to Patients With Cancer Participating in Phase 1 Clinical Trials, Roberts et at. Journal of the American Medical Association 292: 2130-2140, Nov 3, 2004 (abstract freely available)
Medicare Takes Steps Broadening Coverage of Cancer Care, The New York Times, Nov 1, 2004 (free registration required; archived, payment required)
"The agency that runs the Medicare program said Monday that it was creating a demonstration project in which cancer doctors will be paid to measure how their patients feel during chemotherapy…the Centers for Medicare and Medicaid Services proposed paying for a variety of colon cancer drugs when those medications are used in any of nine clinical trials that will test their effectiveness against other cancers…"
Report: Merck Tried to Bury Vioxx Concerns for Years, Reuters, Nov 1, 2004 (no longer available)
"Internal e-mails and other documents from Merck & Co. show the company fought for years to keep safety concerns from undermining the drug's commercial prospects, the Wall Street Journal reported on Monday…"
Week of October 25, 2004
Pesticide study to tempt poor to risk kids' health, critics say, The Seattle Times, Oct 31, 2004
"An Environmental Protection Agency proposal to study young children's exposure to pesticides has sparked a flurry of internal agency protests, with several career officials questioning whether the survey will harm vulnerable infants and toddlers.  The EPA announced this month that it was launching a two-year investigation, partly funded by the American Chemical Council, of how 60 children in Duval County, Fla., absorb pesticides and other household chemicals…"
Companies may face tighter regulation over promoting drugs, British Medical Journal, Oct 30, 2004 (abstract freely available)
"…David Studdert and colleagues from the Harvard School of Public Health and Harvard Medical School say that the remarkable increase in regulatory, self regulatory, and prose-cutorial activity that currently focuses on conflicts of interest between doctors and drug companies will intensify…"
Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry - Self-Regulation in the Shadow of Federal Prosecution.  Studdert et al. New England Journal of Medicine 351:1891-1900, Oct 28, 2004 (paid subscription now required for access)
Law is introduced in US Congress to give access to details of clinical trials, British Medical Journal, Oct 30, 2004 (abstract freely available)
"…The Fair Access to Clinical Trials Act would require registration of all human clinical trials involving drugs, “biologics” (blood products, vaccines, gene therapy tissue, and so on), and medical devices at an online database operated by the National Institutes of Health…"
Breast cancer vaccine lawsuit settled, Grand Forks Herald, Oct 29, 2004
"A medical school and a group of about 50 breast cancer patients have agreed to settle a lawsuit over a canceled experimental vaccine program that some patients claimed had kept them alive…Under the proposed settlement…the university would fund the plaintiffs' pursuit of Food and Drug Administration approval for the vaccine, the university said Friday…"
Judge orders a halt to military's forced anti-anthrax shots, The San Francisco Chronicle, Oct 28, 2004
"The Defense Department must immediately stop inoculating soldiers with anthrax vaccine, a federal judge ruled Wednesday, saying the Food and Drug Administration acted improperly when it approved the experimental injections for general use…"
IUSB regains autonomy over projects, South Bend Tribune, Oct 28, 2004 (archived, payment required)
"A year after research involving human subjects was halted briefly at Indiana University South Bend because of problems with the approval process, the campus soon will regain autonomy for reviewing proposed research projects…"
Registration of Clinical Trials - Voluntary or Mandatory? Steinbrook, New England Journal of Medicine 351:1820-1822, Oct 28, 2004 (full article freely available)
"Should the public registration of clinical trials be voluntary or mandatory, as bills introduced earlier this month in Congress would require? What trials should be included?…"
Legislation soon to address `patient safety' in research, Business Line, India, Oct 27, 2004
"With an accent on "patient safety", the Government is set to bring in a legislation to protect the "welfare of a subject" taking part in research of any sort. The Biomedical Research on Human Subjects (Regulation, Control and Safeguards) Bill 2004 has been cleared by the Health Ministry and is currently being whetted by the Law Ministry…"
UN delays cloning vote, The Scientist, Oct 25, 2004
"The legal committee of the UN's General Assembly concluded the year's second day of debating whether to ban human cloning on Friday (October 22) without taking a vote, leaving the issue to percolate further in the minds of the deeply divided—and still undecided—member states…"
Week of October 18, 2004
Our elite soldiers took drug on orders, Sunday Times, Australia, Oct 23, 2004 (no longer available)
"Hundreds of soldiers were ordered to take an anti-malaria drug with psychotic side effects while serving in East Timor, an investigation by The Sunday Times has found… The army's director-general of health, Tony Austin, admitted using soldiers as guinea pigs in clinical trials but claimed "dozens rather than hundreds" took part…"
US government agency to investigate FDA over rofecoxib, British Medical Journal 329:935, Oct 23, 2004 (abstract freely available)
"The US Government Accountability Office, a regulatory watch-dog on federal government spending, is to investigate claims that the Food and Drug Administration attempted to silence one of its senior medical officers when he tried to warn that rofecoxib (Vioxx) caused heart attacks and strokes…"
Secretary’s Advisory Committee on Human Research Protections (SACHRP), Oct 4-5, 2004 Meeting: Agenda, Presentation Materials, Transcripts
U.N. to Debate Anti - Cloning Treaty, The New York Times, Oct 21, 2004 (free registration required; archived, payment required)
" The highly contentious issue of cloning is back on the U.N. agenda, with support among member states for a treaty banning human cloning but divisions over the use of human embryos for medical research…"
Researchers seek to alter impact of haunting memories, The Seattle Times, Oct 20, 2004
"…Logue volunteered for an experiment designed to test whether taking a pill immediately after a terrorizing experience might reduce the risk of post-traumatic stress disorder (PTSD). The study is part of a promising but controversial field of research seeking to alter, or possibly erase, the impact of painful memories — a concept dubbed "therapeutic forgetting" by some…"
Double boost for research ethics in developing nations,, Oct 20, 2004
"The United Nations Educational, Scientific and Cultural Organisation (UNESCO) is in the final stages of launching its Global Ethics Observatory (GEO), a collection of online databases and other resources aimed at strengthening research ethics in UN member states…"
Global Ethics Observatory Website, UNESCO
FDA approves temporary artificial heart for patients awaiting transplant, The San Francisco Chronicle, Oct 18, 2004
"The Food and Drug Administration said Monday it has approved the first temporary artificial heart for use in patients at risk of dying within 30 days as they await a heart transplant… Because the clinical trial enrolled so few people, the FDA is requiring the company to monitor an additional 50 patients for one year after they receive the implant…"
Painful Withdrawal for Makers of Vioxx, Washington Post, Oct 18, 2004 (free registration required)
"…An examination of how and why Merck reacted offers an unusual look at how safety issues are handled in clinical trials once a drug is on the market and the complex business of weighing risks against benefits. Even as Merck was deciding to withdraw the drug, there were medical experts arguing that it should not. It also shows that federal regulators often rely on drug companies to tell them that a product is dangerous. The whole saga, industry experts said, raises unsettling questions about aggressive consumer marketing of drugs before their long-term safety has been proven…"
Groups question industry-paid doctors, Seattle Post-Intelligencer, Oct 18, 2004 (no longer available)
"They led influential medical groups, starred at prestigious meetings, published in top journals and were undisputed giants in their field. But when these famous doctors advised the government recently on new cholesterol guidelines for the public, something else they had in common wasn't revealed… critics say the doctors' coziness with drug companies compromises their credibility and undercuts their latest advice that more people would benefit from these medications…"
Week of October 11, 2004
WMA sets rules on how doctors handle industry sponsorship, British Medical Journal, Oct 16, 2004 (abstract freely available)
"The World Medical Association has published its first guidelines on how doctors should handle their relationship with commercial enterprises.  The guidelines, which cover medical conferences, gifts, research, and affiliations, are a bid to satisfy the public’s demands for greater transparency in doctors’ relationship with the pharmaceutical industry…"
WMA Press Release, Oct 9, 2004
Suicide warning ordered on drugs, The Boston Globe, Oct 16, 2004
"The US Food and Drug Administration ordered yesterday the manufacturers of all 32 antidepressant drugs sold in America to add a stern ''black box" warning to their packaging that says the drugs put children and adolescents at greater risk for suicidal thinking and behavior…"
FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated With Antidepressant Medications, FDA News, Oct 15, 2004
Suicidality in Children and Adolescents Being Treated With Antidepressant Medications, FDA Public Health Advisory, Oct 15, 2004
FDA Labeling Change Request Letter for Antidepressant Medications, Oct 15, 2004 (includes “black box” text)
Pfizer Says Bextra, Heart Problems Linked, Reuters, Oct 15, 2004 (no longer available)
"Pfizer Inc. on Friday said two small clinical trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack…"
ID chip for humans wins approval by FDA, The Seattle Times, Oct 14, 2004
"A microchip that can be implanted under the skin to give doctors instant access to a patient's records won government approval yesterday, a step that could revolutionize medical care but is raising alarm among privacy advocates…"
Harvard researchers seek OK to produce cloned human embryos, The San Francisco Chronicle, Oct 13, 2004
"Harvard researchers want to be the first in the United States to produce cloned human embryos for disease research. A team of researchers has asked a university ethics review board for permission to conduct research using embryonic stem cells…"
Parental Willingness to Have Children Participate in Clinical Trials Depends on Many Different Factors, Harris Interactive Press Release, Oct 13, 2004 (scheduled to be available until Oct 20, 2004, still available)
"When asked directly, only one in four U.S. adults (25%) would consider allowing their children to participate in clinical research studies. However, many factors can increase the willingness to participate…The most powerful reasons for participation would be the hope that the drug would cure their children (75%) or that their children had a terminal illness (73%). These are some of the results of a Harris Interactive« poll of 5,822 U.S. adults conducted online between May 10 and 17, 2004 for the Wall Street Journal Online's Health Industry Edition…"
Clarification on Declaration of Helsinki, World Medical Association Press Release, Oct 11, 2004
"The World Medical Association has clarified one of its ethical guidelines to physicians on biomedical research to ensure that those people taking part in research would continue to have access to proven beneficial treatment following the research study…"
The Declaration of Helsinki, World Medical Association Ethics Unit
Guidelines needed for MDs in drug trials, The Toronto Star, Oct 11, 2004 (no longer available)
"Stringent guidelines are needed to ensure there is no financial conflict of interest when doctors are paid to take part in patient studies to test experimental drugs or other treatments, an article in the Canadian Medical Association Journal says…"
Physician remuneration in industry-sponsored clinical trials: the case for standardized clinical trial budgets, Ferris and Naylor, Canadian Medical Association Journal 171: 883-886, Oct 12, 2004
Randomized clinical trials: Slow death by a thousand unnecessary policies?, Yusuf, Canadian Medical Association Journal 171: 889-892, Oct 12, 2004
Rebuttal Ferris and Naylor, Canadian Medical Association Journal 171: 892-893, Oct 12, 2004
Week of October 4, 2004
Report: Other drugs may raise heart risks, Seattle Post-Intelligencer, Oct 6, 2004 (no longer available)
"The safety of Celebrex and other pain relievers was questioned Wednesday as scientists in the United States and regulatory agencies in Europe said they feared such drugs might raise the same risk of heart problems as those blamed on the arthritis medicine Vioxx.  One key researcher charged the U.S. Food and Drug Administration did not do everything needed to make sure the drug was safe and called for a congressional review of how Vioxx was approved…."
The New England Journal of Medicine articles referenced in this news report are:
Failing the Public Health -- Rofecoxib, Merck, and the FDA, Topol, New England Journal of Medicine, Oct 6, 2004 (full article freely available)
Coxibs and Cardiovascular Disease, FitzGerald, New England Journal of Medicine, Oct 6, 2004 (full article freely available)
FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product, FDA News, Sept 30, 2004
Merck Announces Voluntary Worldwide Withdrawal of VIOXX«, Merck Press Release, Sept 30, 2004
UK scientists unhappy with EU Clinical Trials Directive, Cordis News, Oct 6, 2004
"The EU's Clinical Trials Directive is a poorly drafted law preventing vital medical research, claim UK scientists…Critics elsewhere had already stated that although the directive's fundamental premise is commendable - to streamline and harmonise regulations governing clinical trials across the EU while protecting the trials' participants - the increase in financial and legal requirements would prove devastating…It would appear the directive has already led to the halt, across the EU, of a number of trials planned by research groups…"
FDA Docket No. 2004N-0432, CDER 2003165.  Radioactive Drugs for Certain Research Uses; Public Meeting.  Pages  59569-59572 [FR Doc. 04-22354], Oct 5, 2004 (public meeting on November 16, 2004; written or electronic comments due before Jan 16, 2005)
"…Since we added Sec.  361.1 in 1975, there have been numerous developments in imaging technology, pharmacology, toxicology, and dosimetry that have had a significant impact on the use of radioactive drugs. In light of these changes, we are considering whether issuance of guidance on, or even revision of, Sec.  361.1 would be appropriate…"
Submit comments here. When page opens, click on Docket Search (top left of page).  At Docket ID type in “2004N-0432”.  Please note: it can take a few days for a docket to be listed for electronic comment.
South Africa: Vaccine Research Struggles to Find Trial Participants,, Oct 5, 2004 (archived; paid subscription required to access archive)
"South African HIV vaccine research efforts are being threatened by the low number of people willing to participate in trials, said the Medical Research Council (MRC).  According to researchers from the MRC in the port city of Durban, the fear of stigma and discrimination from their communities prevented people from taking part in the trials. The country began conducting vaccine trials in November 2003…"
Family finds hope for boy in gene therapy, Pittsburg Post-Gazette, Oct 4, 2004
"When Zachary Balog's hair is closely cropped, you can see the little round bare spots, scars from the six burr holes that a doctor drilled into the boy's skull June 1…He's the first patient to undergo gene therapy for Batten disease, so the major questions are whether it will be safe and whether it will work at all. Significant improvement or even a cure are only possibilities, not probabilities…"
Race influences participation in clinical trials,, Oct 4, 2004
"Caucasian and non-Caucasian cancer patients are equally interested in learning about clinical trials. However, non-Caucasian patients are less likely to enroll in a trial unless the chances are high that it would benefit them, according to a new study presented October 4, 2004…"
FDA Docket No. 2004D-0440, CDER 2003195.  Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability.  Pages  59239-59240 [FR Doc. 04-22204], Oct 4, 2004 (comments due by Jan 3, 2005)
"FDA is announcing the availability of a draft guidance for industry entitled “Computerized Systems Used in Clinical Trials.” This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA…This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999…"
The Draft Guidance (PDF file)
The Draft Guidance (Word document)
Submit comments here. When page opens, click on Docket Search (top left of page).  At Docket ID type in “2004D-0440”.  Please note: it can take a few days for a docket to be listed for electronic comment.
Week of September 27, 2004
Desperate patients seek access to drugs in testing stages, Fort Wayne News-Sentinel, Oct 1, 2004
"…In some cases, a doctor, drug company and the Food and Drug Administration will jointly agree to give a patient an experimental drug, a term known as compassionate use.  But compassionate use poses difficult ethical questions for doctors, drug companies and regulators…"
Confronting the Ethical Challenges to Informed Consent in Emergency Medicine Research, SAEM Ethics Committee et al., Academic Emergency Medicine 11: pp. 1082-1089, Oct 1, 2004 (abstract freely available)
"This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject…"
Commission adopts proposal for children's medicines, Cordis News, Sept 30, 2004
"On 29 September the European Commission adopted a proposal for new European regulations on medicinal products for paediatric use. The aim of the proposal is to improve the health of European children by increasing the research and development of children-specific medication and ensuring the authorisation of medicines developed to meet their therapeutic needs…"
Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use…, Sept 29, 2004
Antidepressants' risk to children spurs a study on adults, The Boston Globe, Sept 29, 2004
"The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants…"
Death of artificial heart patient attributed to malfunction, The San Francisco Chronicle, Sept 28, 2004
"The maker of the first self-contained artificial heart has sent three executives to a Kentucky hospital to investigate the first death attributed to a malfunction in one of the devices…A doctor who sits on an independent advisory panel overseeing a clinical trial of the AbioCor heart suggested Tuesday that the death may justify holding off on plans to implant the device into a final patient in the nearly completed trial…"
NIH seeks consulting ban, The Scientist, Sept 27, 2004
"Under a proposal announced last week, all employees of the National Institutes of Health (NIH), including intramural scientists, would be barred from engaging in paid consulting activities with drug and biotech companies for at least 1 year while the agency reviews its procedures and develops more effective oversight systems…"
Push is on to make sense of drug trials, Houston Chronicle, Sept 27, 2004 (no longer available)
"Scientists are conducting thousands of medical experiments that can offer tantalizing hope to the ill, but tracking them down and getting enrolled can be incredibly difficult…"
Research Thin on Antidepressants and Children, National Public Radio’s Morning Edition, Sept 27, 2004 (requires Windows Media Player or Real Player)
"Experts say more research is needed to understand how antidepressants affect children, especially in the early weeks of use. At the same time, little research exists about when to stop taking the drugs…"
SEC focusing on drug makers, The Boston Globe, Sept 27, 2004
"The Securities and Exchange Commission is scrutinizing biotechnology companies as part of a wider effort to ensure that companies don't mislead investors by covering up negative results of clinical trials…"
Week of September 20, 2004
Medical privacy law said to be chilling cancer studies, The San Francisco Chronicle, Sept 26, 2004
"For 16 years, California's Cancer Registry has been dutifully logging the names and addresses of all state residents who come down with the dreaded disease, their type of cancer and whether they live or die. Researchers at universities across the country mine that data…Since April 14, 2003, however, a new federal law designed to protect the privacy of medical records has made it harder, if not impossible, for medical researchers in the United States to troll through patient charts…"
SSRI Studies Expose Conflicting Roles for FDA, National Public Radio’s All Things Considered, Sept 24, 2004 (requires Windows Media Player or Real Player)
"whether the Food and Drug Administration (FDA) can both ensure public safety and industry confidentiality. The agency has come under tremendous pressure from Congress recently over a class of antidepressant drugs called SSRIs. For months, the FDA had studies questioning the safety and effectiveness of these drugs in children -- but didn't make the studies public until pressured by Congress and the media…"
Office for Human Research Protections (OHRP) Updated Human Subject Regulations Decision Charts, Sept 24, 2005
"The revised decision charts provide graphic aids to assist institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The charts address decisions on the following: I. whether an activity is research that must be reviewed by an IRB, II. whether the review may be performed by expedited procedures, and III. whether informed consent or its documentation may be waived…"
FDA epidemiologist says agency pressured him on antidepressants, The San Diego Union-Tribune, Sept 23, 2004
"The Food and Drug Administration is likely to require antidepressants to carry strong, "black box" warnings about links between increased suicidal behavior in children who take the drugs, an agency official said Thursday…Also Thursday, a government epidemiologist said his bosses asked him to soften his recommendation that most antidepressant use by children be discouraged because of increased suicidal behavior among young people who took the drugs…"
Congressional Testimony, FDA Office of Medical Policy Director Robert Temple, M.D., before the House Subcommittee on Oversight and Investigations. Antidepressant Use in Pediatric Populations, Sept. 23, 2004
Study Finds Less Youth Antidepressant Use, The New York Times, Sept 21, 2004 (free registration required; archived, payment required)
"The number of teenagers and children being prescribed antidepressants in the United States dropped 18 percent over the last year after studies found that the medicines appeared to lead some to become suicidal, according to one provider of drug benefits…"
Drugs, suicide link is not new, The Boston Globe, Sept 21, 2004
"Although suicide was linked officially to antidepressant use in children only last week, the connection is not new and the risks may not stop at puberty. Suspicions first raised in the late 1980s never were scientifically established because company data were kept private and because it is tricky to prove why a depressed person committed suicide. The Food and Drug Administration is considering reexamining whether the antidepressants are linked to suicide in adults…"
Drug Study Registries Raise Competitive Concerns, Reuters, Sept 20, 2004 (no longer available)
"Drug makers are worried that calls for greater disclosure of early-stage clinical trials might lead to the release of scientific information that could help competitors, an industry lobbyist said on Monday. The industry likely will oppose efforts by medical journals to force companies to reveal the existence of the earliest studies, known as Phase I trials…"
Week of September 13, 2004
Sept 18, 2004 is the first ever global Medical Ethics Day.
Doctors say they're ready to perform face transplant, Indianapolis Star, Sept 19, 2004 (no longer available)
"Even as ethicists and others raise concerns, a team of doctors from Louisville and the Netherlands says it is ready to perform a face transplant…"
Mere suggestion of warning label already prompting more caution, The San Francisco Chronicle, Sept 18, 2004
"Alarmed at a recommendation that antidepressants for children carry a strict new warning label, some parents are not letting their youngsters take the drugs as part of a clinical trial for young people who have attempted suicide…"
Officials reject claims of drug industry's influence, British Medical Journal, Sept 18, 2004 (abstract freely available)
"Questioned repeatedly about the effect of the drug industry  on doctors' prescribing, medical education, scientific research,  and drug evaluation, government officials told a parliamentary  inquiry last week that there was no evidence of unhealthy influence…  senior officials…were giving evidence  at the first public hearing of the far reaching inquiry of the  House of Commons Health Committee into the industry's influence  on the health system…"
FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees, Sept 16, 2004
"The Food and Drug Administration (FDA) generally supports the recommendations that were recently made to the agency by the Psychopharmacologic Drugs and Pediatric Advisory Committees regarding reports of an increased risk of suicidality (suicidal thoughts and actions) associated with the use of certain antidepressants in pediatric patients…"
Analysis: Drug Firms Walk Tightrope on Trials Disclosure, Reuters, Sept 16, 2004 (no longer available)
"Drug companies, already struggling to find enough new medicines to sustain historic growth rates for their businesses, face a dilemma as demands increase for them to reveal results of all clinical trials…"
Trial Registration. A Great Idea Switches From Ignored to Irresistible, Rennie, JAMA 292:1359-1362, Sept 15, 2004 (full content freely available)
Strong warning on antidepressants urged, The Seattle Times, Sept 15, 2004
"Antidepressants should come with the nation's strongest warning — in a black box on the label — that they can sometimes spur suicidal behavior in children and teenagers, the government's scientific advisers decided yesterday…"
Attention Deficit Study In Healthy Children Can Proceed Under Certain Conditions, Cmte. Says,, Sept 15, 2004
"A National Institutes of Health proposal to administer dextroamphetamine to healthy children should be allowed to proceed under certain conditions, FDA's Pediatric Ethics Subcommittee recommended Sept. 10 at its inaugural meeting…"
Clinical Trials Partnership Seeks to Boost Research in Developing Countries, Bosch JAMA 292:1290, Sept 15, 2004 (extract freely available)
"The African office of the European and Developing Countries Clinical Trials Partnership (EDCTP) opened for business on July 26 in Cape Town, a milestone for a new initiative designed to bring together European and poor nations to combat poverty-related diseases…"
European and Developing Countries Clinical Trials Partnership Programme (EDCTP)
FDA links drugs to being suicidal, The New York Times, Sept 14, 2004 (free registration required; archived, payment required)
"An expert panel advising the Food and Drug Administration recommended today that antidepressants carry a warning in a black box on the label saying that the medications can sometimes lead children and teenagers to become suicidal…"
Health privacy law hinders research, The Washington Times, Sep 14, 2004
"US law on the privacy of healthcare information hinders researchers and slows the progress of clinical trials, analysts said…"
Privacy rule builds biomedical research bottleneck, EurekAlert!, Sept 13, 2004
"The Privacy Rule implemented as part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 is constraining researchers in the United States and slowing the progress of a wide range of clinical studies and biomedical research…many studies may simply move offshore…"
Medical Schools Tighten Conflicts of Interest Standards But Room for Improvement Remains, According to AAMC Study, American Association of Medical Colleges (AAMC) Press Release, Sept 13, 2004
"…In addition, the study revealed that institutions are using a variety of safeguards to help manage COI in human subjects research…The survey results indicate that 81 percent of institutions permit a researcher with a significant financial interest to conduct human subjects research when they find that compelling circumstances exist…"
US Medical School Policies on Individual Financial Conflicts of Interest. Results of an AAMC Survey, Ehringhaus and Korn, Sept 2004 (pdf file)
For current versions of AAMC documents on conflict of interest, click here.
Week of September 6, 2004
Q&A Dr. Jeffrey M. Drazen on drug trial results, The Boston Globe, Sep 12, 2004
"The editors of 11 top medical journals shook up the staid world of academic publishing this past week when they decided to stop printing results of drug trials that aren't registered in a central database. Globe biotechnology reporter Jeffrey Krasner spoke with Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, about how the policy should change drug development and clinical practice…"
FDA panel says child stimulant study OK, Seattle Post Intelligencer, Sept 11, 2004 (no longer available)
"A new Food and Drug Administration ethics panel said the advancement of science outweighed the risks of giving a stimulant to healthy children as young as 9…"
Correction: FDA Pediatric Ethics story, Seattle Post Intelligencer, Sept 15, 2004 (no longer available)
"In a Sept. 10 story about whether healthy children should be given a stimulant in a research experiment, The Associated Press reported erroneously that 10 mg of dextroamphetamine was equivalent to the caffeine in five cups of coffee…"
MPs launch inquiry into influence of drug industry, British Medical Journal, Sept 11, 2004 (abstract freely available)
"The House of Commons Health Committee held its first public hearing this week as part of a wide ranging inquiry into the influence of the pharmaceutical industry over the health system. The committee is investigating drug companies' influence on medical research, the education of doctors, health information, and drug evaluation. It will specifically look at the industry's influence on the NHS, the National Institute for Clinical Excellence and other regulatory authorities, universities, professional societies, and the media…"
Patient group calls for better understanding of drug trials in the US, British Medical Journal, Sept 11, 2004 (abstract freely available)
"It is important that the public be engaged at every level of decision making for all clinical research, according to Fran Visco, president of America’s National Breast Cancer Coalition. Ms Visco was speaking at a day long clinical roundtable discussion, organised by the Institute of Medicine on 2 September, to look at how to build public trust in clinical research…"
House berates FDA, drug makers, The Scientist, Sept 10, 2004
"At a day-long hearing in Washington, DC, yesterday (September 9), the House Energy and Commerce Subcommittee on Oversight and Investigations repeatedly took both Food and Drug Administration (FDA) and pharmaceutical company officials to task for failing to fully disclose clinical trial results…"
Drug Firms Blasted for Hiding Antidepressant Data, NPR Morning Edition, Sept 10, 2004 (requires Windows Media Player or Real Player)
"In Capitol Hill hearings, lawmakers criticize drug manufacturers for failing to fully disclose data on the use of antidepressants by children, creating a misleading impression of the drugs' safety and effectiveness. The FDA is also faulted for being too passive a regulator…"
Lawmaker: FDA Resisting Antidepressant Probe, Reuters, Sept 9, 2004 (no longer available)
"A top Republican lawmaker on Thursday charged the U.S. Food and Drug Administration with hindering a congressional investigation into whether the agency suppressed a possible link between antidepressant use and suicidal behavior in youth…"
Major Medical Journals Will Require Registration of Trials, The New York Times, Sept 9, 2004 (free registration required; archived, payment required)
"A group of leading medical journals yesterday released a plan to stop publishing the results of clinical trials unless a test is registered at its outset in a public database…"
Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors,  De Angelis et al. Annals of Internal Medicine 141, originally published Sept 8, 2004
Bill to seek posting of results of drug trials, The Boston Globe, Sept 9, 2004
"Legislation to be introduced within days in the US House and Senate would require drug companies to publicly register clinical trials and post the results on a government-run website… According to the legislation, registration would be a condition of all trials approved by the ethics boards of hospitals and universities where they are conducted…"
Firms to post drug data, The Boston Globe, Sept 8, 2004
"…The Pharmaceutical Research and Manufacturers of America, the industry's Washington lobbying arm, will launch a website on Oct. 1 that will include test results of the safety and effectiveness of drugs on the market…"
NIH proposes free public access to scientific research, The Boston Globe, Sept 7, 2004
"The National Institutes of Health has proposed a major policy change that would require all scientists who receive funding from the agency to make the results of their research available to the public for free…"
NIH Notice: Enhanced Public Access to NIH Research Information, NOT-OD-04-064, Sept 3, 2004 (public comment opportunity; comments due within 60 days)
To submit comments, use the NIH Public Comment Page
New DOH clinical trials policy announcement draws some criticism,, Sept 7, 2004
"The [Taiwan] Department of Health (DOH) Deputy Minister Chen Zai-jin announced Saturday that market mechanisms will soon be introduced into the government's clinical trials development policy…However, this declaration is being strongly criticized by some medical authorities…"
Secrecy Barring Doctors from Cancer Data - Charity, Reuters, Sept 6, 2004 (no longer available)
"A combination of industry secrecy, lack of money and shortage of time is keeping the results of many clinical cancer trials locked away and depriving doctors of crucial information, campaigners said on Monday…."
Glaxo Faces Lawsuits from US Parents Over Paxil, Reuters, Sep 6, 2004 (no longer available)
"GlaxoSmithKline Plc is facing a number of lawsuits from U.S. parents of children and adolescents given its antidepressant Paxil, following claims the company suppressed data showing the drug increased suicidal tendencies in young people…"
Merck Says It Will Post the Results of All Drug Trials, The New York Times, Sept 6, 2004 (free registration required; archived, payment required)
"Merck & Company says it will post the results of its clinical trials on drugs on a Web site run by the National Institutes of Health…"
Week of August 30, 2004
FDA considers ethics of child stimulant tests, The Boston Globe, Sept 4, 2004
"Is it ethical in the name of science to give a healthy child as young as 9 a controlled substance? That's the dilemma facing the Food and Drug Administration's Pediatric Ethics subcommittee at its first-ever meeting next Friday…"
FDA Guidance for Industry and Clinical Investigators: The Use Of Clinical Holds Following Clinical Investigator Misconduct, Sept 2, 2004
"This guidance provides information on one use by the Food and Drug Administration (FDA) of its authority to impose a clinical hold on a study or study site if FDA finds that human subjects are or would be exposed to an unreasonable and significant risk of illness or injury…"
GlaxoSmithKline begins releasing data on drug trials, The San Francisco Chronicle, Sept 2, 2004
"GlaxoSmithKline PLC has taken a first step toward fulfilling a promise to disclose the results of every drug trial it sponsors by posting summaries on the Internet…"
GlaxoSmithKline Clinical Trial Register
Problem device bypassed trials, The Boston Globe, Sept 1, 2004
"The catheter that triggered three safety recalls by Boston Scientific Corp. of its best-selling Taxus coronary stent after being linked to three deaths and 47 injuries had not been subjected to the rigors of a human clinical trial, FDA records show…critics say Taxus points to an Achilles' heel in the regulatory process when it comes to safeguarding the public from faulty medical products…"
Protection of Human Subjects in Intervention Research for Suicidal Behavior. Oquendo et al. American Journal of Psychiatry 161:1558-1563, September 2004 (abstract freely available)
"CONCLUSIONS:  It is possible to design a randomized, controlled trial that minimizes the risk of morbidity and mortality for suicidal patients with bipolar disorder, but deliberation is required to address the bioethical tensions that arise…"
Experts call for more women and youth participation in AIDS vaccine trials, UN News Service, Aug 31, 2004 (no longer available)
"With women at least twice as likely to become infected with HIV as men when exposed to the virus that causes AIDS - and six times as vulnerable in parts of sub-Saharan Africa - HIV vaccine clinical trials must be geared towards meeting their needs, the United Nations health agency said today…"
Paralyzed Americans travel to Chinese doctor implanting fetal cells, Monterey County Herald, Aug 30, 2004
"A Chinese neurosurgeon has been besieged by desperate Americans willing to pay $25,000 for an implant of cells from aborted fetuses, a controversial and scientifically unproven procedure that the doctor claims has helped patients with spinal injuries or the nervous-system disease known as ALS but has alarmed Western researchers…"
Week of August 23, 2004
Glaxo to release negative drug data, The Boston Globe, Aug 26, 2004
"GlaxoSmithKline PLC agreed Thursday to release negative data on the safety and effectiveness of its drugs to settle a lawsuit by New York's attorney general that accused the pharmaceutical maker of misrepresenting data on prescribing its antidepressant drug Paxil to children…"
Drug Controller Plans To Keep Tabs On Contract Research, The Financial Express, India, Aug 25, 2004
"In what could be an ideal remedy for controlling the mushrooming contract research organisations (CROs) and their quality across the country, the Drug Controller General of India (DCGI) is working out a policy which demands accreditation of CROs with the apex body for obtaining approval on any kind of tests conducted on human beings…"
Lop-sided features linked to temper, Nature, Aug 24, 2004 (paid registration now required)
"In a study of stressful telephone conversations, those with uneven faces and bodies were more prone to angry reactions…Zeynep Benderlioglu of Ohio State University in Columbus and her colleagues got around the problem by recruiting 100 volunteers and tricking them…"
Week of August 16, 2004
Experts question ethics, New York Newsday, Aug 20, 2004 (no longer available)
"A government plan to test the effects of a prescription stimulant on children's brains has triggered a rare request for a special review to determine whether it meets safety and ethical guidelines…experts in medical ethics and health law have questioned some aspects of the proposed research…"
Solicitation of Public Review and Comment on Research Protocol: Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study (Subpart D IRB Referral).  Docket No. 2004N-0337, OC 2004196.  Pages  47158-47159 [FR Doc. 04-17825], Published Aug 4, 2004.
Documents related to the proposed research are available here, at OHRP's website.
Antidepressants to Reflect Suicide Risk, Reuters, Aug 20, 2004 (no longer available)
"The U.S. Food and Drug Administration plans to update antidepressant labels to reflect studies that suggest a link between the drugs and suicide in youths, but remains cautious about the strength of such ties, according to documents released on Friday…"
FDA Updates Its Review of Antidepressant Drugs in Children, FDA Talk Paper, Aug 20, 2004
"…the Food and Drug Administration (FDA) is issuing this update to provide health care providers and patients with the most current information on this topic. FDA has completed a new analysis of pediatric suicidality (suicidal thoughts and actions) data submitted to the agency and will be posting its analysis on its web site. FDA will also be posting on its web site additional summaries of pediatric efficacy studies from drugs that have been studied in depression in pediatric patients…"
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies, Center for Drug Evaluation and Research (CDER), FDA, Aug 20, 2004
Study: Prozac, therapy help depressed kids, Indianapolis Star, Aug 18, 2004 (no longer available)
"The best treatment for depressed adolescents is a combination of Prozac and talk therapy, although the antidepressant does carry a risk that some patients might harm themselves or others, concluded a long-awaited study released Tuesday…The new study was eagerly anticipated by doctors, parents and regulators because virtually all other clinical trials of antidepressants have been conducted by pharmaceutical companies…"
Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents With Depression. Treatment for Adolescents With Depression Study (TADS) Randomized Controlled Trial, Treatment for Adolescents With Depression Study (TADS) Team, JAMA: 292:807-820, August 18, 2004 (abstract freely available)
UK promotes children-specific drug research, Cordis News, Aug 18, 2004
"In a move welcomed by doctors and medical experts, the UK health minister, Lord Warner, has announced a new initiative to encourage the development of medicines designed specifically for children…"
Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals, Emmanuel et al. Annals of Internal Medicine 141: 282-291, August 17, 2004 (abstract freely available)
"Developing appropriate reform proposals requires carefully  delineating the problems of the current system to know what  reforms are needed. To stimulate a more informed and meaningful  debate, we delineate 15 current problems into 3 broad categories…we outline components of a more  effective reform proposal…"
Researchers working for full disclosure of clinical trials, Grand Forks Herald, Aug 16, 2004
"In criminal proceedings in the United States, the prosecution is legally required to provide the defense with any information that might be beneficial to the defendant - even if it may hurt the prosecution's case. Scientists are bound to a similar type of disclosure through an unwritten code of ethics…"
Father's quest seeks two medical miracles, Newsday, Aug 16, 2004 (no longer available)
"Since Nathan, now 10, was diagnosed with Batten disease in 1999, Phil Milto has almost single-handedly designed a business plan to run a gene therapy experiment…. Milto, who lives near Indianapolis, designed the business plan for the studies to find the perfect vector, or delivery system, to house the packets of genes. He bought the mice, bought the monkeys, bought all the equipment…Then, he got his children enrolled in the experimental gene therapy study…"
Week of August 9, 2004
Controversy over Outsourcing Drug Clinical Trials to India, All Things Considered, National Public Radio, Aug 13, 2004 (requires Real Player or Windows Media Player)
"Many U.S. technology jobs have been outsourced to India, and now there are reports medical research is being transferred there, too. Clinical trials that cost millions in the United States cost only thousands to perform in India. It's raising questions about the ethics of using subjects who have little exposure to Western medicine, and whether they're fully aware of the risks and benefits of participating in drug trials. One issue: There may be no benefit to those suffering illness in India if the drugs being tested are too expensive for poor Indians to afford…"
NIH ethics report draws critics, The Scientist, Aug 12, 2004
"The US Office of Government Ethics (OGE) wants the National Institutes of Health (NIH) to enact far more restrictive conflict-of-interest regulations on outside consulting activities than those proposed by NIH Director Elias A. Zerhouni and a special 'blue ribbon' panel of experts…"
FDA clears Lilly drug in suicide, Indianapolis Star, Aug 12, 2004 (no longer available)
"The Food and Drug Administration has concluded that Eli Lilly and Co.'s newly approved antidepressant Cymbalta didn't trigger Traci Johnson's suicide at the Lilly Laboratory for Clinical Research…Johnson, 19, a former Indiana Bible College student, hung herself with a scarf Feb. 7 in a bathroom of the drugmaker's Indianapolis drug-testing clinic during a study to see how high doses of the drug affected healthy volunteers…"
UK grants cloning license, The Scientist, Aug 12, 2004
"Britain's Human Fertilisation and Embryology Authority (HFEA) said on Wednesday (August 11) that it had granted the country's first license to create human embryonic stem cells using cell nuclear replacement…"
China needs its own psychology: expert, People’s Daily, Aug 12, 2004
"As a large nation with 1.3 billion people, China urgently needs to develop a more localized psychology, said experts at the ongoing 28th International Congress of Psychology (ICP) Wednesday… western psychology is rooted in western culture and uses westerners as research subjects…Experts believe that China will gradually set up its own psychological research system with 10 years…"
Cambodian leader orders anti-AIDS drug test stopped, The San Francisco Chronicle, Aug 11, 2004
"Cambodia's premier ordered a halt to plans for human trials of an anti-AIDS drug in his country that would have recruited hundreds of sex workers to determine if the medicine could prevent new HIV infections…"
Drug firms move biotech work to India, The Boston Globe, Aug 11, 2004
"Drug makers in the United States and Europe are increasingly moving clinical trials and research work to India, which helped Indian firms earn $54 million in revenue in the last fiscal year, a trade body said Wednesday…"
Office for Human Research Protections (OHRP) Guidance on Research Involving Private Information or Biological Specimens, Aug 10, 2004 (pdf file, public comment opportunity)
"The Office for Human Research Protections (OHRP) has issued guidance on research involving coded private information or human biological specimens. The document also references pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens…"
Submit comments on this document at the OHRP web site. Click on “Public Comments” at the bottom of the left sidebar menu to email your comments.
Buffalo case highlights MTAs, The Scientist, Aug 9, 2004
"The indictments of two US professors accused of fraud for their alleged misuse of bacteria provide a lesson to scientists that material transfer agreements (MTAs)—which many researchers consider irksome red tape—can be used against academics in court, especially in today's climate of heightened biosecurity, say attorneys and technology transfer officials…"
Week of August 2, 2004
Youth risk of suicide, medication revisited, The Indianapolis Star, Aug 8, 2004 (no longer available)
"A new Food and Drug Administration analysis of clinical-trial data shows evidence of a link between antidepressant drugs and suicidal tendencies among young people…"
Secret US report surfaces on antidepressants in children, British Medical Journal, Aug 7, 2004 (abstract freely available)
"Internal memos and a secret government report about the negative  effects of antidepressants in children—suppressed by the US Food and Drug Administration—have surfaced publicly…"
Namibia: Official Aids Guidelines Launched,, Aug 6, 2004 (archived; paid subscription required to access archive)
"A set of guidelines governing the conduct of research and clinical trials on human subjects, including HIV-positive subjects, has been released by Namibia's Ministry of Health…"
Guidelines On Hand for Research, Clinical Trials,, Aug 5, 2004 (archived; paid subscription required to access archive)
"The Ministry of Health and Social Services has produced guidelines that will govern the conduct of research and clinical trials on human subjects…"
Lawmaker seeks clinical trial data, Indianapolis Star, Aug 5, 2004 (no longer available)
"The chairman of the Senate Finance Committee has asked drug makers -- including Indianapolis-based Eli Lilly and Co. -- to turn over their clinical trial data on antidepressants…"
In Drug Research, the Guinea Pigs of Choice Are, Well, Human, New York Times, Aug 4, 2004 (free registration required; archived, payment required)
"Researchers at the University of Munich repeated the experiment 70 times: a healthy volunteer would receive a chemical injection, then be left alone to ride out an artificially induced panic attack…"
Ecstacy Research: Debate over drug's uses. Researchers are studying potential benefits of using the so-called 'club drug' to help trauma victims, New York Newsday, Aug 4, 2004 (archived; payment required)
"Somewhere in Charleston, S.C., in a safe bolted to the floor and protected by an alarm system, Michael Mithoefer keeps his supply of Ecstasy… Mithoefer, a psychiatrist, is one of a handful of people in the United States allowed to do human research with Ecstasy, which the government puts in the same legal category as heroin…"
Spitzer Asks Drug Maker for Off-Label Use Material, New York Times, Aug 4, 2004 (free registration required; archived, payment required)
"Johnson & Johnson said yesterday that the New York attorney general, Eliot Spitzer, had asked for information about six of its drugs, including marketing materials, the results of clinical trials and data on prescriptions for so-called off-label use…"
NIH to Set Stiff Restrictions on Outside Consulting, Washington Post, Aug 3, 2004 (free registration required)
"A top official at the National Institutes of Health yesterday detailed restrictions and disclosure requirements soon to be imposed on agency scientists who wish to consult for outside companies -- a response to a string of embarrassing revelations about lucrative contracts and other apparent conflicts of interest…"
Lilly to disclose drug trial results, Boston Globe, Aug 3, 2004
"Responding to an "erosion" of public trust in drug trial data, Eli Lilly and Co. promised Tuesday to post online the research results -- good and bad -- for every drug it sells…"
Cambodia PM Opposes Testing Anti-HIV Drug, Monterey Herald, Aug 3, 2004
"Prime Minister Hun Sen said Tuesday he opposes the testing of drugs on Cambodians, a position that could derail a planned trial for an anti-AIDS medicine here…"
Minnesotan files lawsuit over anti-depressant for children, Grand Forks Herald, Aug 3, 2004
"GlaxoSmithKline committed fraud and misrepresented data on the effectiveness of prescribing its anti-depressant Paxil to children, according to a lawsuit filed in U.S. District Court…"
Ethics review procedures for research in developing countries: a basic presumption of guilt, Gilman and Garcia, Canadian Medical Association Journal 171, Aug 3, 2004
"…The point has often been made that research in developing countries poses particular ethical issues, but our experience of more than 18 years of collaborative research in Peru persuades us that efforts to provide ethical oversight of research in developing countries are often duplicated unnecessarily and are frequently based in trivial, misplaced or simply invalid concerns…"
Some leery of posting test data, Boston Globe, Aug 2, 2004
"Major biotechnology firms support releasing negative clinical trial results, but they are not willing to go as far as some big drug companies, including one that will begin posting such data online…"
FDA/OHRP News and Notices
Food and Drug Administration; 21 CFR Part 14; Advisory Committee; Pediatric Advisory Committee; Establishment; Federal Register: Vol 69, No 147, Page 46098-46099, Published on Aug 2, 2004
"The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner…Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee…This committee will provide advice and make recommendations to the Commissioner of Food and Drugs on matters relating to pediatric therapeutics, pediatric research, and any other matter involving pediatrics for which the Food and Drug Administration has regulatory responsibility. The committee will also advise and make recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services…"
Request for Nominations for Voting and Nonvoting Members on a Public Advisory Committee; Pediatric Advisory Committee.  Federal Register Pages  46151-46152 [FR Doc. 04-17541]  OC 2004189, Published Aug 2, 2004. (Nominations due August 17, 2004)
"The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Pediatric Advisory Committee in the Office of the Commissioner… Nominations received on or before August 17, 2004 will be given first consideration for membership…"
FDA Forms Pediatric Ethics Subcommittee,, Aug 3, 2004
"FDA is creating an ethics subcommittee of the new Pediatric Advisory Committee.  The subcommittee will address pediatric ethical issues, as well as institutional review board referrals related to clinical investigations involving children…"
Dextroamphetamine Study Including Healthy Children Will Be First Test For Pediatric Ethics Subcmte,, Aug 3, 2004
"FDA’s Pediatric Ethics Subcommittee will consider whether the scientific merit of a proposed NIH study outweighs the risk of administration of dextroamphetamine to healthy children during its inaugural meeting on Sept. 10…"
Solicitation of Public Review and Comment on Research Protocol: Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study (Subpart D IRB Referral).  Docket No. 2004N-0337, OC 2004196.  Pages  47158-47159 [FR Doc. 04-17825], Published Aug 4, 2004. (Comments due August 20, 2004)
"The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), HHS are soliciting public review and comment on a proposed research protocol entitled 'Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD); A Functional Magnetic Resonance Study.'…"
Documents related to the proposed research are available here, at OHRP's website.
Submit electronic comments here.  When page opens, click on Docket Search (top left of page).  At Docket ID type in "2004N-0337".
FDA Analysis Of Antidepressant Pediatric Suicidality Data To Be Reviewed Sept. 13-14,, Aug 3, 2004
"FDA’s analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13 & 14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee…"
Week of July 26, 2004
Canadian RCTs to have new registration rules, British Medical Journal, July 31, 2004 (abstract freely available)
"All randomised controlled trials (RCTs) funded by the Canadian Institutes of Health Research—Canada’s primary funding agency for health research—will require registration with the International Standard Randomised Controlled Trial Number (ISRCTN). The institutes’ president, Dr Alan Bernstein, said that the goal was to ensure greater access worldwide to information about the trials…"
Cancer patients sue after med school cuts treatment, Chicago Sun-Times, July 29, 2004 (no longer available)
"A North Chicago medical school violated medical ethics when it cut off a research treatment program for more than 50 women with breast cancer -- putting their lives at risk, according to a lawsuit filed Wednesday in Cook County…"
FDA Docket No. 2004N-0114, OC 2004176.  Agency Information Collection Activities, Submission for Office of Management and Budget Review; Institutional Review Boards.  Pages  43852-43853 [FR Doc. 04-16628] (comments due Aug 23, 2004)
"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995…"
Special Education and Debate Section, British Medical Journal
New ethics committee regulations hinder research, British Medical Journal 329, July 31, 2004
"Five papers and an editorial show how ethics committees impede, delay, and sometimes distort research…"
Academic medicine campaign: Obstacles to conducting epidemiological research in the UK general population, Ward et al. British Medical Journal 329, July 31, 2004 (abstract freely available)
"Experiences from a national case-control study of Creutzfeldt-Jakob disease show the tensions between protecting individual patients' confidentiality and the access required for the benefit of public health…"
The other face of research governance, Jones and Bamford, British Medical Journal 329, July 31, 2004 (abstract freely available)
"After inadvertently making an unauthorised protocol deviation, two researchers were left with a weakened study and feeling disillusioned…"
Commentary: View from the research and development office, Soteriou, British Medical Journal 329: July 31, 2004 (abstract freely available)
"The NHS trust that I work for, which funded the research highlighted by Jones and Bamford, sees research as integral to providing high quality health and social care services, and research governance is paramount to our research strategy…In the case highlighted here, communication about the reasons behind the actions of the research and development office was clearly not adequate, and we regret that the researchers felt unduly stressed…"
Bureaucracy of ethics applications, Wald, British Medical Journal 329: July 31, 2004 (abstract freely available)
"One research group decided to determine exactly how much effort is required to get ethical approval by recording the submission of its first application under the new UK system…"
Commentary: Better support for investigators is essential, Meredith, British Medical Journal 329: July 31, 2004 (abstract freely available)
"Wald's description of his encounter with the new research ethics committee forms provides a graphic illustration of the frustration and bemusement of most researchers when faced with the hurdles that must now be surmounted to conduct a clinical trial…"
Research ethics paperwork: what is the plot we seem to have lost?, Jamrozik, British Medical Journal 329: July 31, 2004 (abstract freely available)
"The standardisation of applications to local research ethics committees seems likely to make ethical approval less efficient and more time consuming for everyone…"
Ethical review of research into rare genetic disorders, Parker et al., British Medical Journal 329: July 31, 2004 (abstract freely available)
"Although some work on rare diseases is clearly clinical investigation and some clearly research, much activity falls uneasily between the two. Where should we draw the line and how can we ensure research gets appropriate ethical review?"
Week of July 19, 2004
Dying patients help with clinical trials, Witchita Eagle, July 25, 2004 (scheduled to be available until July 31, 2004, still available)
"Six years ago, Sister Mary Andrew Matesich was 59 and the president of Ohio Dominican University. She loved her work, her students, her life. But she had reached a crossroad. Breast cancer, first treated when she was 54, had come back and begun to spread…So she signed up to receive an experimental treatment…"
US government to open national bank of "approved" embryonic stem cells, British Medical Journal, July 24, 2004 (abstract freely available)
"The US Department of Health and Human Services has announced that it will accelerate stem cell research by establishing centres of excellence in translational stem cell research and a national embryonic stem cell bank using stem cells lines derived before 9 August 2001…"
Draft guidance on clinical trials recognises needs of non-commercial research, British Medical Journal, July 24, 2004 (abstract freely available)
"Academic researchers are cautiously welcoming new draft guidance on clinical trials published recently by the European Commission…"
European Commission Draft Guidance on Clinical Trials (pdf file; comments due by July 30, 2004)
Secretary’s Advisory Committee on Human Research Protections (SACHRP), July 22, 2004 meeting: Agenda, Minutes, Presentation Materials
Thompson Launches "Decade of Health Information Technology", DHHS News Release, July 21, 2004
"HHS Secretary Tommy G. Thompson today released the first outline of a 10-year plan to transform the delivery of health care by building a new health information infrastructure, including electronic health records and a new network to link health records nationwide.  At the same time, he announced a number of new action steps to help advance health information technology immediately…"
Government Wants to Bring Health Records Into Computer Age, New York Times, July 21, 2004 (free registration required; archived, payment required)
"The Bush administration plans to announce today a long-term plan for modernizing the nation's health care system with information technology, bringing patient records and prescriptions out of the realm of ink and paper and into the computer age…"
Results of Drug Trials Can Mystify Doctors Through Omission, New York Times, July 21, 2004 (free registration required; archived, payment required)
"… But labels are often allowed to remain silent about a test when the F.D.A. turns down a company's application for approval of a new use or a new patient group…The labeling issue is another facet of an expanding debate over the incomplete disclosure and publication of the results of clinical drug trials…"
Study of Antidepressants Finds Little Disparity in Suicide Risk, Boston Globe, July 21, 2004
"Amid an international debate about the side effects of drugs taken for depression, a large-scale analysis of British medical records has found little difference in rates of suicidal behavior among patients given some of the most commonly prescribed medications…"
Antidepressants and the Risk of Suicidal Behaviors.  Jick et al. JAMA 292: 338-343, July 21, 2004 (abstract freely available)
Doctor participation lags behind demand for clinical trials, American Medical Association News, July 19, 2004
"A new online survey of doctors by Harris Interactive found that 11% of physicians were interested in becoming clinical investigators but did not know where to get started while 17% were not interested in such work…"
New Database Focuses on Genetic Policy and Laws, NIH News, July 19, 2004
"The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), today unveiled a new Web-based resource that will enable researchers, health professionals and the general public to more easily locate information on laws and policies related to a wide array of genetic issues…"
NHGRI Policy and Legislation Database
Week of July 12, 2004
FDA to Establish New Cancer Office and Program, FDA News, July 16, 2004
"The Food and Drug Administration (FDA) today announced plans to make significant changes to its organizational structure to provide for an even stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat, and prevent cancer…"
Clinical Trials Controversy Spotlights Flawed System, Psychiatric News, American Psychiatric Association, July 16, 2004
"The ongoing controversy surrounding SSRIs in children is now threatening the very foundations of clinical drug research on the efficacy and safety of all of the drugs physicians prescribe…"
Prostitutes protest AIDS-drug test. Bay Area company hit with charges of exploitation, San Francisco Chronicle, July 14, 2004
"On the podium in the Grand Ballroom at the 15th International AIDS Conference…Dr. Joel Gallant suddenly found himself surrounded Tuesday by angry, chanting Cambodian prostitutes… The protesters, led by ACT UP Paris, were demanding that Gilead, sponsor of the disrupted seminar, provide lifetime health care for any participant in the study who became HIV-positive -- a price they felt the company should pay for allegedly endangering the lives of the young women who enrolled in the experiment…"
Shortage of volunteers slows drug development, News-Leader, July 13, 2004 (no longer available)
"The medical world needs more Phyllis Morellos. This self-effacing nursery-school teacher from Garfield, N.J., volunteered for one of the hundreds of clinical trials in the Philadelphia region, agreeing to have an experimental pacemaker implanted in her stomach to see whether it would help her digestive problems…"
European health surveys neglect minority groups, claims report, Cordis News, July 12, 2004
"UK scientists have issued a report calling for more ethnic participation in European health studies in order to assess who benefits from research. The study, carried out by the University of Edinburgh, has revealed that Europe is trailing behind the US in recruiting people from ethnic minorities to take part in health studies…"
Comparison of reporting of ethnicity in US and European randomised controlled trials, Sheikh et al. British Medical Journal 329: 87-88, July 10, 2004.
Week of July 5, 2004
Clinical trials are driven by hope. But studies are complex, face ethical, safety issues, Deseret News, July 11, 2004 (scheduled to be available until July 17, 2004, still available)
"Jeff Vance, 40, thinks he's probably still considered terminally ill. Colorectal cancer had spread by the time he discovered he had it. But no one's marking his time in months now. And he's feeling ‘really good.’…"
PhRMA urges more disclosure, The Scientist, July 9, 2004
"A new set of guidelines issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) calling for the release of more data from clinical trials is being met with guarded skepticism by advocates who have been clamoring for increased transparency…"
PhRMA Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results, June 30, 2004 (pdf file)
WHO Wants to Start Drug Trial Registry. Proposal to Be Made in November, Washington Post, July 8, 2004 (free registration required)
"The World Health Organization wants to establish an international registry of drug trials to ensure that the public finds out when medications do not work, as well as when they do, officials said yesterday…"
Drug firms flout law by failing to report test data, FDA says, Seattle Times, July 7, 2004
"The pharmaceutical industry has repeatedly violated federal law by failing to disclose the existence of large numbers of its clinical trials to a government database, according to the Food and Drug Administration…"
Department of Health and Human Services Proposed Rule: Institutional Review Boards: Registration Requirements.  RIN Number 0940-AA06.  Federal Register Vol. 69, Pages 40584-40590, July 6, 2004 (pdf file; Comments due October 4, 2004)
"The Office for Human Research Protections (OHRP)…is proposing to require registration of institutional review boards (IRBs) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP…"
FDA Proposed Rule: Institutional Review Boards; Registration Requirements.  Docket No. 2004N-0242, OC 200125.  Federal Register Vol. 69, Pages 40556-40562, July 6, 2004 (pdf file; Comments on information collection provisions due August 6, 2004; Comments on proposed rule due October 4, 2004)
"The Food and Drug Administration (FDA) is proposing to require institutional review boards (IRBs) to register at a site maintained by the Department of Health and Human Services (HHS)…"
Week of June 28, 2004
Force drug firms to release trial data, doctors urge. Medical journal editors draft plan to make all results public, Ottawa Citizen, July 4, 2004 (no longer available)
"A plan to lift the veil of secrecy shrouding drug trials is being drafted by editors of the world's leading medical journals…"
Blood substitute goes into use in area Thursday, Pioneer Press, June 30, 2004 (no longer available)
"Loyola University Health System plans to test PolyHeme, an investigational oxygen-carrying blood substitute designed to increase survival of critically injured and bleeding trauma patients at the scene of injury, beginning Thursday as part of a national clinical trial…"
PolyHeme« Blood Substitute Trauma Trial Study Web Page, Loyola University Health System
Forest Asked to Supply Information on Marketing of Some Drugs, New York Times, June 29, 2004 (free registration required; archived, payment required)
"Forest Laboratories said yesterday that it had received a wide-ranging request from the New York attorney general, Eliot Spitzer, asking for information about how the company tested and promoted drugs…"
Drug Marketing, Talk of the Nation, National Public Radio, June 29, 2004 (requires Windows Media Player or Real Player)
"Join NPR's Neal Conan for a look at the high-stakes business of drug marketing and its new opponents. Guests: Gardiner Harris, New York Times Science Reporter; Catherine Deangelis, Executive Editor, Journal of the American Medical Association (JAMA); Scott Lassman, Assistant General Counsel Pharmaceutical Research and Manufacturers of America (PhRMA); Richard Blumenthal, Connecticut Attorney General…"
Week of June 21, 2004
OHRP restructures web site, announced June 21, 2004,
As Doctors Write Prescriptions, Drug Company Writes a Check, New York Times, June 27, 2004 (free registration required; archived, payment required)
"The check for $10,000 arrived in the mail unsolicited. The doctor who received it from the drug maker Schering-Plough said…"
Drug Maker Acknowledges Some Negative Test Results, New York Times, June 26, 2004 (free registration required; archived, payment required)
"Forest Laboratories has said a recently concluded test found that its antidepressant Lexapro did not help depressed children and adolescents…"
NIH needs 'drastic changes', The Scientist, June 23, 2004
"National Institutes of Health (NIH) director Elias A. Zerhouni yesterday (June 22) told Congress that "drastic changes" are needed to effect a "major reform" of the NIH's ethics rules, practices, and procedures…"
NIH unaware of scientists' deals. Ethics inquiry finds more than reported, Boston Globe, June 23, 2004 (scheduled to be available until July 22, 2004, still available)
"Drug makers including Pfizer Inc. reported about 100 consulting agreements with scientists at the US National Institutes of Health that the government-funded research organization didn't know about, according to a lawmaker who is leading an ethics inquiry…"
Democrats Take a Look at Drug Tests, New York Times, June 23, 2004 (free registration required; archived, payment required)
"Two medical groups involved in the issue of the disclosure of clinical drug trials are expected to meet tomorrow with staff members of several Democratic senators who may soon introduce legislation…"
US misconduct rules examined, The Scientist, June 22, 2004
"While supporting most of the proposed changes to rules governing misconduct in federally sponsored research, representatives of professional research societies and US medical schools are expressing "serious concerns" and "strong objections" to several changes that would, among others, shift the burden of proof in investigations from institutions or the government to individual scientists…"
Public Health Service Policies on Research Misconduct; Proposed Rule, 42 CFR Parts 50 and 93, Federal Register, 20777-20803, April 16, 2004 (pdf file)
UK to open stem cell center, The Scientist, June 22, 2004
"The United Kingdom founded a new ú16.5 million (USD $30 million) stem cell center in Cambridge this week with a commitment to fundamental research on both human embryonic and adult stem cells as a precursor to studying therapeutic applications…"
Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments, FDA, Federal Register Docket No. 2004N-0254, CDRH 200435, June 21, 2004.  (pdf file, comments due Aug 20, 2004)
Week of June 14, 2004
OHRP new toll-free telephone number announced; (866) 447-4777 [HHS-HRPP], June 14, 2004
A Medical Journal Quandary: How to Report on Drug Trials, New York Times, June 20, 2004 (free registration required; archived, payment required)
"The issue of The American Journal of Psychiatry that hit the desks of its 37,000 readers this month reported test results for the antidepressant drug Celexa, indicating it could help children and teenagers…"
Antidepressants Restudied for Relation to Child Suicide, New York Times, June 20, 2004 (free registration required; archived, payment required)
"A child stabs himself in the neck with a pencil. Another slaps herself in the face. Is either suicidal?…"
Glaxo Plans Public Listing of Drug Trials on Web Site, New York Times, June 19, 2004 (free registration required; archived, payment required)
"GlaxoSmithKline, facing complaints that it selectively disclosed results from pediatric trials of its popular antidepressant drug Paxil, said yesterday that it planned to create a company Web site that would publicly list all clinical trials…"
Merck Backs U.S. Database to Track Drug Trials, New York Times, June 18, 2004 (free registration required; archived, payment required)
"Merck, one of the world's leading pharmaceutical companies, says it supports the idea of a government-run database that would keep track of all late-stage clinical drug trials…"
Under Pressure Glaxo Publishes Paxil Data, Reuters, June 16, 2004 (no longer available)
"GlaxoSmithKline Plc , responding to a lawsuit claiming it suppressed negative data about its antidepressant Paxil, published results of trials showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behavior…"
Paroxetine and Pediatric and Adolescent Patients, GlaxoSmithKline Web Site, June 14, 2004
"GlaxoSmithKline has conducted a series of clinical studies to determine the efficacy and safety of paroxetine in treating children and adolescent patients with major depressive disorder, obsessive compulsive disorder and social anxiety disorder/social phobia. In the interest of further making the results of these studies available to all interested parties, GSK is posting to this Web page the following documents…Clinical Study Reports, Bibliography of Publications, Medical Information Letter"
A.M.A. Adds Its Voice to Call For Disclosure on Drug Trials, New York Times, June 16, 2004 (free registration required; archived, payment required)
"The nation's largest doctors' group, the American Medical Association, adopted a resolution yesterday that urges the federal government to create a database in which all clinical drug trials performed in this country would be registered at the outset of the trials…"
AMA pushes for public drug study registry, San Francisco Chronicle, June 15, 2004
"The American Medical Association called on the government Tuesday to establish a public registry for all drug study results -- even research funded by pharmaceutical companies that reflects poorly on their products…"
Medical Journals May Force Disclosure of Bad Trials, Reuters, June 15, 2004 (no longer available)
"Editors of the leading medical journals are considering a proposal that would make drug companies disclose trials that shed unfavorable light on their products, The New York Times reported on Tuesday…"
Medical Journals Weigh Plan for Full Drug-Trial Disclosure, New York Times, June 15, 2004 (free registration required; archived, payment required)
"An organization of top medical journals is considering a proposal that would require drug makers to register clinical trials at their start in a public database…"
Week of June 7, 2004
G-8 adopts plan to speed HIV vaccine, San Francisco Chronicle, June 10, 2004
"The Bush administration won backing from major allies for a proposal to accelerate development of an HIV vaccine, and President Bush on Thursday proposed spending $15 million to launch it…"
FDA Proposed Rule: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application, Jun 10, 2004  (pdf file, comments by Sept 8, 2004)
"The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC)…"
Age, race and sex disparity found in cancer research trial participation, EurekAlert, June 8, 2004
"Although people age 65 and older account for 62 percent of patients with lung, colon, breast or prostate cancer, they make up only 32 percent of cancer research participants, Yale researchers report in the June 9 Journal of the American Medical Association…"
Participation in cancer clinical trials. Race, sex and age-based disparities. Murthy et al. JAMA 291: 2720-2726, June 9, 2004 (abstract freely available)
Doctors argue over use of placebos in cancer trials, San Francisco Chronicle, June 8, 2004
"In a controversial shift, some of the most promising new cancer drugs are heading into clinical trials where only some patients will get the actual drug. Other patients will be given a placebo…"
Gene therapy: two steps forward, one step back, Johnston and Bayliss, Canadian Medical Association Journal 170, June 8, 2004
"Until recently, a trial at H˘pital Necker Enfants Malades in Paris involving children with X-linked severe combined immunodeficiency disease (X-SCID, also known as "bubble-baby syndrome") stood as the only unequivocal success story in gene transfer research… However, the story abruptly changed on Oct. 3, 2002…"
New patient tools needed to reliably report side effects in chemotherapy clinical trials, EurekAlert, June 7, 2004
"Almost half the symptoms experienced by patients enrolled in chemotherapy clinical trials are not reported by their clinician, according to a study conducted by Oregon Health & Science University Cancer Institute researchers…"
Week of May 31, 2004
FDA Review of "Outside Activity" Requests Identifies No Additional Approved Outside Activities of Concern. Acting Commissioner Dr. Lester M. Crawford Nevertheless Strengthens FDA Ethics Oversight, FDA News Release, June 4, 2004
"Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today announced the results of a comprehensive review of all "outside activities" performed by FDA employees… As a result of one incident being identified within FDA, Dr. Crawford directed that a review of all current outside activity requests from FDA employees be conducted…."
Two Studies, Two Results, and a Debate Over a Drug, New York Times, June 3, 2004 (registration required; archived, payment required)
"The two drug trials were known within SmithKline Beecham as Study 329 and Study 377.  Study 329 suggested that the company's popular drug Paxil might help depressed adolescents…"
Spitzer sues GlaxoSmithKline over use of antidepressant in children, San Francisco Chronicle, June 2, 2004
"GlaxoSmithKline PLC committed fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children, according to a lawsuit filed Wednesday by New York Attorney General Eliot Spitzer…"
Prozac Appears Safe, Effective in Teens, Health Central, June 2, 2004
"While it may not settle the debate entirely, preliminary findings from a major U.S. government-funded study suggest that antidepressants do not raise the risk of suicide in adolescents…"
Evidence-Based Global Health, Buekens et al., JAMA 291: 2639-2641, June 2, 2004 (full article)
"The effectiveness of many interventions to improve health in poor populations in the developing world remains untested and therefore unproven…"
Scientists accused of cherry-picking, Sydney Morning Herald, June 1, 2004 (scheduled to be available until June 8, 2004, still available)
"Scientists are routinely singling out the results of clinical trials so they can present the findings they want, a study by academics at Oxford University shows…"
Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials, Chan et al. Journal of the American Medical Association 291: 2457-2465, May 26, 2004 (abstract freely available)
NIH clinical trial initiative: Agency reaches out to primary care, American Medical News, May 31, 2004
"Community-based physicians do not often look to the vast National Institutes of Health for answers to questions that haunt them daily, whether they involve the care of diabetic patients or the expeditious handling of lab results…"
Week of May 24, 2004
Harvard Medical amends policies, Boston Globe, May 29, 2004
"Harvard Medical School has increased the amount of stock faculty members can own in firms utilizing their research, but placed stricter limits on their involvement in the management of such firms, under a new policy that could influence commercial ties at hospitals and medical schools nationwide…"
First stem cell bank in the world is opened in UK, British Medical Journal, May 29, 2004 (abstract freely available)
"The first stem cell bank in the world opened last week in the United Kingdom, with the aim of providing an international resource for storing, characterising, and supplying ethically approved, quality controlled, stem cell lines for research and, ultimately, for treatment."
AMA to urge publication of all med studies, Washington Times, May 27, 2004 (no longer available)
"An American Medical Association panel is supporting the development of print and electronic databases for all clinical trials and their results…"
Loyola decides to test new blood substitute in trauma patients at the scene of injury, EurekAlert, May 27, 2004
"Loyola University Health System plans to test PolyHeme«, an investigational oxygen-carrying blood substitute designed to increase survival of critically injured and bleeding trauma patients at the scene of injury, beginning July 1, 2004, as part of a national clinical trial…"
Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials, Chan et al. Journal of the American Medical Association 291: 2457-2465, May 26, 2004 (abstract freely available)
Face transplants inch toward reality, CNN, May 26, 2004
"Doctors in Kentucky have begun preparing a document to be submitted to an ethics panel at the University of Louisville School of Medicine seeking permission to perform a face transplant, the lead researcher in the endeavor told CNN…"
In debate over antidepressants, FDA weighed risks, San Francisco Chronicle, May 25, 2004
"Last December, drug-safety analyst Andrew Mosholder delivered a blunt message to his colleagues at the Food and Drug Administration: Young people taking antidepressants were more likely to become suicidal…"
Researchers neglect deadliest diseases, Globe and Mail, May 25, 2004 (free registration required; archived, payment required)
"Medical research is the cornerstone of efforts to eradicate death and disease. Yet if medical journals are any indication, there is a disconcerting disconnect between what researchers are studying and the leading causes of death and illness around the world…"
Rochon et al. Relation between randomized controlled trials published in leading general medical journals and the global burden of disease. Canadian Medical Association Journal 170, May 25, 2004
Week of May 17, 2004
Medical research re-examined. 25 years later, protecting the vulnerable still vital, Milwaukee Journal Sentinel, May 22, 2004  (free registration required)
"In the past, it was illiterate black men in the South, poor Mexican-American women, orphans and the mentally retarded. Today it might be prisoners, children with incurable diseases, central city toddlers, people with certain gene profiles . . . maybe even people on Medicare…."
Britain moves to supply stem cells for research, Boston Globe, May 20, 2004
"Britain opened the world's first stem cell bank yesterday, the centerpiece of an effort to place the United Kingdom at the center of a promising but controversial area of biological research…"
Legislators question HHS ethics, Boston Globe, May 19, 2004
"Top legal and ethics officials within the Department of Health and Human Services have repeatedly allowed government scientists to engage in lucrative consulting deals with pharmaceutical and biotechnology companies while ignoring the concerns of lower-level ethics officers, according to evidence presented at a House subcommittee hearing yesterday…"
Conflict probe expands to FDA, The Scientist, May 19, 2004
"The US Food and Drug Administration (FDA) will conduct a “comprehensive review” of all outside consulting agreements its employees have with pharmaceutical and biotech companies to make sure the arrangements are legal, acting FDA commissioner Lester M. Crawford announced yesterday"
Statement by Dr. Lester M. Crawford, Acting FDA Commissioner, on Outside Activities of FDA Employees, May 18, 2004
Week of May 10, 2004
Harnessing Science: Advancing Care by Accelerating the Rate of Cancer Clinical Trial Participation.  Statement by Richard Pazdur, Director, Division of Oncology Drug Products, CDER FDA before the Committee on Government Reform, US House of Representatives, May 13, 2004
Lapses cited in Harvard clinical trials, Boston Globe, May 13, 2004
"Federal health officials recently found ethical lapses in eight Harvard Medical School experiments involving human subjects and have asked the school to enact measures that would heighten protections for patients involved in clinical trials there…"
HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects, HHS News Release, May 12, 2004
"HHS Secretary Tommy G. Thompson today released new guidance for protecting research subjects from possible harm caused by financial conflicts of interest that may arise in research studies…"
Federal Register Notice: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
Week of May 3, 2004
Health panel: Tighten rules on outside pay, Seattle Times, May 7, 2004
"Senior officials at the National Institutes of Health should be barred from accepting income of any kind from drug companies, a panel examining conflict of interest at the agency recommended in its final report yesterday…"
Report of the NIH Blue Ribbon Panel on Conflicts of Interest Policies, National Institutes of Health, May 6, 2004
Local meetings planned on use of artificial blood, Richmond Times-Dispatch, May 5, 2004
"VCU Medical Center officials have set a date to answer public questions about research on an experimental blood substitute that will be given to trauma patients too injured to consent to the research…"
Agency Guidances Promote Comprehensive Efforts to Minimize Risks While Preserving the Benefits of Medical Products, FDA News, May 4, 2004 (public comment accepted until July 6, 2004)
"The Food and Drug Administration (FDA) is announcing the availability of three draft guidances to help industry develop risk management activities when needed for some drugs and biological products.  The documents…address safety issues that can arise throughout a product's entire lifecycle, including its development, the review and approval process, and after it is available on the market."
Premarketing Risk Assessment
Development and Use of Risk Minimization Action Plans
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
U.S. Is Losing Its Dominance in the Sciences, New York Times, May 3, 2004 (registration required; archived, payment required)
"The United States has started to lose its worldwide dominance in critical areas of science and innovation, according to federal and private experts who point to strong evidence like prizes awarded to Americans and the number of papers in major professional journals…"
Week of April 26, 2004
Squeezing academic research into a commercial straitjacket, British Medical Journal, May 1, 2004 (extract freely available)
"A new European directive on clinical trials that takes effect this week may seriously damage academic medical research by applying a "one size fits all" approach to the organisation of clinical trials that is more suited to trials designed for the regis tration of new drugs by pharmaceutical companies…"
Huge study to look at threats to kids’ health, Indianapolis Star, Apr 28, 2004 (no longer available)
"Several federal agencies have teamed up to launch one of the most ambitious biomedical projects in history -- a massive study to identify the biggest threats to children's health…"
Week of April 19, 2004
Cancer trial participants rarely told of results, Reuters, Apr 20, 2004 (no longer available)
"People with cancer who participate in clinical trials are often left in the dark about the results of the studies, according to a new report…"
Secretary’s Advisory Committee on Human Research Protections (SACHRP), March 2004 transcripts
Week of April 12, 2004
Health fears halt vaccine trial, Nature, Apr 15, 2004 (paid registration now required)
"Recruitment for clinical trials of a smallpox vaccine being mass-produced for the US government has stopped after three cases of a heart condition cropped up in participants…"
NIH consulting limits urged, The Scientist, Apr 13, 2004
"Scientists at the National Institutes of Health (NIH) may consult with pharmaceutical and biotech companies as long as they spend fewer than 500 hours a year in these outside activities, publicly disclose all payments, and do not receive stock or stock options, according to recommendations being readied by NIH's "blue ribbon" panel on conflict of interest policies, a draft copy of which was obtained by the Los Angeles Times last week…"
On the medical front line, Washington Times, Apr 12, 2004
"Twice before when she had come to Washington to be part of an innovative procedure at the National Institutes of Health Clinical Center, Lorie Evilzisor of Urbana, Ohio, had missed seeing the cherry blossoms…"
Clinical trials without ethical review under the spotlight, Bulletin of the World Health Organization, April 2004
"A recent series of unethical, and in some cases illegal, clinical trials in India is fuelling concern over the incidence of clinical trials conducted without ethical approval in other countries where legislation may be either inadequate or not implemented…"
Week of April 5, 2004
Jury finds Hutch not negligent in 4 deaths, Seattle Times, Apr 9, 2004
"A jury yesterday decided in favor of the Fred Hutchinson Cancer Research Center and against four people who sued the center in the deaths of their spouses in a medical experiment there 20 years ago…"
WHO and science publishers team up on online register of trials, British Medical Journal, Apr 10, 2004 (extract freely available)
"The World Health Organization has teamed up with a group of biomedical publishing experts to register its trials on an online database…"
Current Controlled Trials Website
Joint Statement issued regarding principles for fixed-dose combination drug products, HHS News Release, Apr 8, 2004
"In Gaborone, Botswana, government officials and representatives of drug regulatory agencies from 23 nations, the research-based and generic pharmaceutical industries, public health leaders, health care providers, advocacy groups (including persons living with HIV/AIDS), academia and members of non-governmental organizations held discussions from March 29-31 on the scientific and technical principles for fixed-dose combination drug products (FDCs) for use in the treatment of AIDS, tuberculosis and malaria…"
Link to Conference Draft Report (available Mid-April 2004, public comment opportunity)
Bernard A. Schwetz to Head Office for Human Research Protections, HHS News Release, Apr 8, 2004
"HHS Secretary Tommy G. Thompson today announced the appointment of Bernard A. Schwetz, D.V.M., Ph.D., as the director of the Office for Human Research Protections (OHRP)…"
Psych prof scrutinized, Daily Northwestern, Apr 8, 2004
"Two formal complaints filed against Northwestern psychology Prof. J. Michael Bailey allege he practiced as a clinical psychologist without a license and published confidential information about transsexual women he interviewed without their permission, according to documents obtained by The Daily this week…"
State faults hospital for use of stent, Delaware NewsJournal, Apr 7, 2004 (no longer available)
"A state report released Tuesday concluded the Alfred I. duPont Hospital for Children failed to follow the proper procedures for using an experimental medical device and failed to get parents' permission for an innovative heart procedure…"
FDA sat on study linking pills to child suicide risk , Seattle Times, Apr 6, 2004
"Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence…"
Week of March 29, 2004
Deliberations to begin in suit against ‘Hutch’, Seattle Times, Apr 1, 2004
"After eight weeks of testimony, jurors will begin deliberating today whether the Fred Hutchinson Cancer Research Center was negligent and failed to inform five patients of the risks in a medical experiment 20 years ago…"
Privacy law thwarts medical research,, Mar 31, 2004
"In today's climate of fear over having medical records disclosed, researchers complain that doing important public health research has become impossible…"
‘Hutch’ experiment’s risks were known, expert testifies, Seattle Times, Mar 31, 2004
"The risks of dying from an experimental form of bone-marrow transplant were well-known before the Fred Hutchinson Cancer Research Center began Protocol 126, according to expert testimony yesterday…"
Doctor ‘was sure’ Hutch experiment could save lives, Seattle Times, Mar 30, 2004
"The doctor who ran a controversial medical experiment at the Fred Hutchinson Cancer Research Center testified that, even after patients began developing a rare but fatal complication, he kept the experiment going because he thought he could save more lives than would be lost…"
Red tape threatens non commercial research in Europe, Canadian Medical Association Journal, Mar 30, 2004
"Proposed European Union laws that harmonize rules for clinical trials and aim to improve patient safety also threaten the future of noncommercial research in EU member states, say leading researchers on both sides of the Atlantic…"
Week of March 22, 2004
NIH and FDA Launch New Human Gene Transfer Research Data System, NIH News, Mar 26, 2004
"The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) announced today that they have launched a new Genetic Modification Clinical Research Information System (GeMCRIS) — a Web-accessible database on human gene transfer…"
Research on kids needs tighter rein, panel says, Baltimore Sun, Mar 26, 2004 (archived, registration required, payment required)
"To avoid putting children at unnecessary risk, pediatric medical research must be more stringently supervised, a panel of experts said yesterday…"
Policy-Makers and Researchers Should Improve Standards for, Evaluation of Clinical Research Involving Children, National Academies Press Release, Mar 25, 2004
"Federal rules to protect children from risky or unethical clinical research should be extended to cover all pediatric research in the public and private sectors, says a new report from the Institute of Medicine of the National Academies…"
Institute of Medicine Report: The Ethical Conduct of Research Involving Children
Experts from leukemia centers defend ‘Hutch’, Seattle Times, Mar 26, 2004
"Five researchers from major leukemia centers say a controversial medical experiment at the Fred Hutchinson Cancer Research Center 20 years ago was similar to experiments they themselves were doing at the same time…"
Hospital accused over use of stent, Philadelphia Inquirer, Mar 25, 2004 (registration required)
"Doctors at a Wilmington hospital used an experimental treatment on a baby without the parents' knowledge, the parents have told federal investigators…"
A new hope for saving of lives, San Diego Union-Tribune, Mar 23, 2004
"Greg Roenfeldt was bleeding to death internally as anxious doctors hovered around him in the UCSD Medical Center trauma room…"
FDA wants tough labels on drugs for depression, San Francisco Chronicle, Mar 23, 2004
"Patients taking antidepressants can become suicidal in the first weeks of therapy, and physicians should monitor patients closely when first giving the drugs or changing dosages, federal drug regulators said Monday…"
Week of March 15, 2004
Doctor says 'Hutch' trial met standard, Seattle Times, Mar 19, 2004
"Dr. Richard O'Reilly, the first expert witness called by lawyers for the Fred Hutchinson Cancer Research Center, testified yesterday that a human test at "The Hutch" 20 years ago was well-conceived, comparable to other trials around the country and properly informed patients of the risks and benefits…"
ASU vows to fight Havasupai lawsuits, Arizona Republic, Mar 18, 2004 (no longer available)
"Arizona State University said Wednesday that it will "vigorously defend" itself against two federal lawsuits seeking $75 million for the misuse of blood and handprint samples from the Havasupai Tribe…"
Medical ethicists critique OHSU study, Corvallis Gazette-Times, Mar 17, 2004
"Medical ethics scholars from around the country have blasted a study of drug testing in high schools conducted by Oregon Health & Science University, but researchers there are defending their study as well-designed, but misunderstood…"
Protocol showed great promise, Hutch Center researcher testifies, Seattle Times, Mar 17, 2004
"The researcher who proposed Protocol 126, a controversial medical trial at the Fred Hutchinson Cancer Research Center, said he thought at the time that the experiment offered great benefits and minimal risks to patients…"
Varmus wants tighter NIH rules, The Scientist, Mar 15, 2004
"In the wake of heightened concern over possible conflicts of interest at the National Institutes of Health (NIH), former NIH Director Harold E. Varmus now believes that institute and center directors should be prohibited from consulting for companies that might be candidates for research grants…"
Week of March 8, 2004
Researcher backs Hutch Center testimony during trial, Seattle Times, Mar 11, 2004
"Nobel laureate Dr. E. Donnall Thomas yesterday testified that researchers at the Fred Hutchinson Cancer Research Center had no way of knowing that so many patients would die in Protocol 126…"
The ‘Hutch’ begins presenting defense, Seattle Times, Mar 10, 2004
"For a month now, the ethics of a failed medical experiment conducted 20 years ago have been dissected in a small Seattle courtroom…"
New NIH cancer network to speed research, Government Computer News, Mar 10, 2004
"The National Institutes of Health’s National Cancer Institute has begun developing a biomedical electronic information network on which scientists can share research data to accelerate the discoveries in cancer care…"
US biosecurity board reviewed, The Scientist, Mar 8, 2004
"Implementing the US government's new program to prevent bioterrorists from seeing cutting-edge research results they could turn into weapons will be a significant challenge whose success is not assured, according to a panel of high-level officials who were involved in creating the program and who spoke at the American Society of Microbiology's (ASM) annual biodefense conference here yesterday (March 8)…"
HHS will lead government-wide effort to enhance biosecurity in “dual use” research, NIH News, Mar 4, 2004
HHS Secretary Tommy G. Thompson today announced that HHS will lead a government-wide effort to put in place improved biosecurity measures for classes of legitimate biological research that could be misused to threaten public health or national security — so-called "dual use" research….
Week of March 1, 2004
Companies Facing Ethical Issue as Drugs Are Tested Overseas, New York Times, March 5, 2004 (subscription required; archived, payment required)
"Dr. Louis Lange, a cardiologist who is chief executive of a small biotechnology company, has a new drug that, if approved, would be the first new treatment for angina in a quarter-century…"
4 subjects challenge Lilly over drug trial, Indianapolis Star, Mar 4, 2004 (no longer available)
"Four participants in an Eli Lilly and Co. drug trial in California said the clinic's staff told them that Traci Johnson, who committed suicide last month during the same study in Indianapolis, had a history of depression…"
Scientists behaving badly, Nature, Mar 4, 2004 (no longer available)
"They lie, they cheat and they steal. Judging by the cases described by a group of medical journal editors, scientists are no different from the rest of us.  Last week's annual report of the Committee on Publishing Ethics…"
Committee on Publication Ethics, The COPE Report 2003
Bush dismisses council members, The Scientist, Mar 3, 2004
"US President George W. Bush dismissed two members of his President's Council on Bioethics last Friday afternoon in a move that has been dubbed a “very ill-advised decision” by the American Society for Biochemistry and Molecular Biology (ASBMB) president Bettie Sue Masters…"
Crunch time for EU directive, The Scientist, Mar 3, 2004
"Even before Europe's new clinical trials directive (2001/20/EC) was signed into EU law, some research bodies were warning that it would have a devastating impact on academic clinical trials…"
EU Directive on Good Clinical Practice in Clinical Trials, Apr 4, 2001
NIH scientists required to disclose income from outside sources, San Diego Union Tribune, Mar 2, 2004
"Scores of top scientists at the National Institutes of Health will be required to disclose income from drug companies and outside employers after a newspaper investigation found possible ethics violations…"
Week of February 23, 2004
‘Hutch’ witness unleashes his anger, Seattle Times, Feb 26, 2004
"Joe Fisher tried to keep his anger bottled up through two days of trial testimony but finally couldn't…"
'Hutch’ doctor tells of doubts about experiment, Seattle Times, Feb 24, 2004
"Twenty years ago, Dr. Rainer Storb, co-founder of the Fred Hutchinson Cancer Research Center, voiced concerns about a revolutionary medical experiment being conducted there…"
UBC broke federal ethics rules by failing to adequately warn patients, Vancouver Sun, Feb 25, 2004 (no longer available)
"The University of British Columbia for years broke federal ethics rules and failed to warn patients of all the dangers and side-effects associated with its medical experiments and drug trials, CanWest News Service has learned…"
Companies pay doctors big bucks for volunteers, Edmonton Journal, Feb 24, 2004 (no longer available)
"The research promoters come courting Dr. Kam Shojania every few weeks…"
Ethical review of research in developing countries needed, EurekAlert, Feb 24, 2004
"Developing countries need to more thoroughly review the research ethics of studies being conducted in their country, but sponsored by other, more developed countries, according to a study conducted by researchers from the Johns Hopkins Bloomberg School of Public Health…"
Clinic has key role in Lilly’s testing of new medications, Indianapolis Star, Feb 24, 2004 (no longer available)
"In its 78 years, the Lilly Laboratory for Clinical Research has been the site of human tests for life-saving treatments of anemia, diabetes, sepsis and all manner of breakthrough drugs…"
Inside the world of medical journals, BBC News Feb 23, 2004
"Richard Horton sees thousands of research papers pass his desk every year. As editor of The Lancet, he decides what is published in one of the world's most prestigious journals…"
Week of February 16, 2004
NIH conflict of interest panel to meet in early March, NIH News, Feb 19, 2004 (public input opportunity)
"National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., announced today that the first meeting of the NIH Blue Ribbon Panel on Conflict of Interest Policies will be held on March 1-2, 2004…"
Panel weighs toxic research on humans, ABC News, Feb 19, 2004 (no longer available)
"Dosing people with toxic pesticides and pollutants for scientific purposes is justified only under strict conditions and with careful review, a National Academy of Sciences panel said Thursday…"
EPA Should Impose Stringent Scientific and Ethical Standards on Studies That Deliberately Expose People to Toxins, and Evaluate Such Experiments To Ensure That Standards Have Been Met, NAS News, Feb 19, 2004
"When regulating chemicals to protect public health, the U.S. Environmental Protection Agency should consider information from studies that involve intentional dosing of humans with toxic chemicals only if such experiments meet the most stringent scientific and ethical standards, ensuring that research participants are protected and that the studies are scientifically necessary and valid, says a new report from the National Academies' National Research Council…"
Report: Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program, National Research Council
Hutch’s former review chief tells of unease at experiment, Seattle Times, Feb 19, 2004
"Dr. Henry Kaplan, now one of Seattle's most-respected cancer doctors, felt very uneasy about a medical experiment being conducted at the Fred Hutchinson Cancer Research Center 20 years ago…"
Couple didn't know treatment was experimental, man testifies, Seattle Times, Feb 18, 2004
"For 17 years, Cullen Couch thought his wife died despite receiving the best care at the renowned Fred Hutchinson Cancer Research Center…"
Faint Warning. From coloured tabs to computerized signals: How Canada tracks dangerous drugs, CBC News, Feb 17, 2004
"It was a pill to help people sleep but it ended up as a wake-up call to the world of drug regulation…"
Search Canada’s Adverse Drug Reaction Database
Albertan’s health records go online despite concerns, Canadian Medical Association Journal (CMAJ), Feb 17, 2004
"Alberta is going ahead with its plan to place confidential patient information online for use by health care professionals, despite concerns about security and allegations of a hidden agenda…"
UK psychiatrists questions SSRI warnings for under 18s, Canadian Medical Association Journal, Feb 17, 2004
"Leading psychiatrists in the UK are expressing misgivings about regulatory action to curb the use of most selective serotonin reuptake inhibitors (SSRIs) to treat depression in children and adolescents…"
UK Committee on Safety of Medicine Summary of Safety and Efficacy Data on SSRIs in Children
Week of February 9, 2004
Cloning creates human embryos, New York Times, Feb 12, 2004 (registration required; archived, payment required)
"Scientists in South Korea report that they have created human embryos through cloning and extracted embryonic stem cells, the universal cells that hold great promise…"
Death fuels fallout in drug trial, Indianapolis Star, Feb 12, 2004 (no longer available)
"Eli Lilly and Co. said Wednesday that nearly one-fifth of the participants in a clinical trial for its new anti-depression and anti-incontinence drug have dropped out of the study after one test subject committed suicide over the weekend…"
HIV drug that shields babies might imperil mothers later, Seattle Times, Feb 10, 2004
"The treatment used in poor countries to prevent the spread of HIV from mothers to their babies might have a serious drawback: It can make the women resistant to the AIDS drugs they may need later on, disturbing new research shows…"
Jury hears objections to ‘Hutch’ experiment, Seattle Times, Feb 10, 2004
"Two former members of the Fred Hutchinson Cancer Research Center's review board testified yesterday that they objected in vain to a controversial medical experiment conducted 20 years ago…"
University examining Bailey’s sex research, Daily Northwestern, Feb 9, 2004
"In a shift of rhetoric from the university, a top official now has said psychology Prof. Michael Bailey is being investigated by a committee in connection with allegations of research misconduct…"
Week of February 2, 2004
Argument over patients’ consent starts Hutch trial, Seattle Times, Feb 6, 2004
"The Fred Hutchinson Cancer Research Center assigned curable patients to its riskiest experiment 20 years ago, and as a result they died, an attorney for the spouses of five patients argued in the first day of trial yesterday…"
Committee probes Bailey’s research methods, ethics, Daily Northwestern, Feb 6, 2004 (no longer available)
"Students in Psychology Prof. J. Michael Bailey's Human Sexuality class learned a different kind of arithmetic lesson last month…"
Science projects needed paperwork, Press Journal, Feb 6, 2004 (archived, payment required)
"The importance of paperwork may have been the biggest lesson learned at this year's Indian River County Regional Science and Engineering Fair…"
Assessing the ethical implications of research into the prevention of bioterrorism, Cordis News, Feb 5, 2004
"With the Commission setting out proposals to establish an EU security research programme on 3 February, it is clear that many regard scientific and technological research as a key response to the perceived increased threat of global terror attacks…"
Ethics at NIH, Chemical and Engineering News, Feb 4, 2004
"Congressional hearing questions agency about conflict-of-interest allegations…"
Company “held back” data on drug for children, The Guardian, Feb 3, 2004
"The British manufacturers of an antidepressant drug that was last year banned from use in children knew as long ago as 1998 that it did not work and deliberately avoided publishing the full data because of the risk to their lucrative adult market, according to a leaked internal document…"
Lawmaker seeks data on antidepressants for kids, Reuters, Feb 3, 2004 (no longer available)
"A U.S. lawmaker asked four drug makers on Tuesday to tell a House committee about any unpublished clinical trials involving antidepressant treatment for children amid a probe into whether some drugs raise the risk of suicide in youngsters…"
Panel urges sterner FDA warnings on children’s suicide risks, San Francisco Chronicle, Feb 3, 2004
"After a day of anguished testimony from concerned parents, a government advisory committee Monday called on the Food and Drug Administration to issue stronger warnings about the possible dangers, including suicidal behavior, to children being prescribed antidepressant drugs…"
FDA to hear views on drugs’ suicide links, Boston Globe, Feb 2, 2004
"After her 11-year-old son began taking the antidepressant Lexapro this summer, Yvette Prayor of Worcester found herself pacing the floors at night…"
Week of January 26, 2004
Trial to open in deaths of cancer patients at Hutch, Seattle Times, Feb 1, 2004
"Spouses of five patients who died in a controversial medical experiment two decades ago are taking their cases against the Fred Hutchinson Cancer Research Center to trial this week…"
US official defends use of sex studies, New York Times, Jan 30, 2004 (subscription required; archived, payment required)
"Responding to criticism from conservatives, the director of the National Institutes of Health has told lawmakers the government should continue to pay for studies of sexual behavior because they could have a powerful impact on public health…"
Trials: For The Sake Of Others, Washington Post, Jan 27, 2004 (scheduled to be available until February 10, 2004, …still available)
"For years many cancer patients and their families have been told that their best -- and in some cases their last -- hope lay in a clinical trial, an experimental study designed to test the safety and effectiveness of a new treatment…"
Improving informed consent for children in cancer treatment studies, EurekAlert, Jan 27, 2004
"A study at six of the nation's leading children's hospitals has concluded that physicians should do a better job in communicating with parents before a child with cancer enrolls in a randomized clinical trial…"
Three resign from U of S ethics board in protest, CBC Saskatchewan, Jan 27, 2004
"Three members of the University of Saskatchewan's ethics review board have quit amid allegations nothing has been learned from recent controversies about what happens to the information gathered through research…"
Week of January 19, 2004
NIH directors no longer drug consultants, LA Times carried by Yahoo News, Jan 23, 2004 (no longer available)
"Top-level officials at the National Institutes of Health - amid sharp criticism from congressional leaders - have stopped accepting consulting fees and stock options from drug companies, the agency's leader told a Senate hearing on Thursday…"
Study devalues a popular idea on evaluating medical trials, New York Times, Jan 23, 2004 (subscription required, archived; payment required)
"A new report by researchers at the Dana-Farber Cancer Institute in Boston has found little evidence to support a widely held belief about clinical trials of experimental cancer treatments: that patients who enroll in them fare better than those who do not…"
Panel says Zoloft and cousins don’t increase suicide risk, New York Times, Jan 22, 2004 (subscription required, archived; payment required)
"Adding to the debate over using antidepressant drugs for depressed teenagers and children, a group of prominent researchers issued a report yesterday saying that Zoloft and similar medicines did not increase children's suicide risk…"
Ethics council ensures first nations respected, CBC Saskatchewan, Jan 22, 2004
"A doctor who sits on the National Council on Ethics in Human Research says there is an increased interest in making sure First Nations involved in medical research are respected…"
Ministry insists on continuing vaccine trials despite criticism, Bangkok Post, Jan 21, 2004 (no longer available)
"The Public Health Ministry yesterday insisted in continuing with the country's first large-scale HIV vaccine trial in Chon Buri and Rayong, despite criticism from American researchers…"
HIV experts pan trial of vaccine, Seattle Times, Jan 16, 2004
"A $119 million federally funded experiment in which an AIDS vaccine is being tested on 16,000 volunteers in Thailand is doomed to fail and should never have been started, 22 leading HIV researchers charge…"
Court document cites allegation on past research, Modesto Bee, Jan 21, 2004
"A professor at the center of a Peterson trial survey scandal ordered a researcher to falsify data on an unrelated poll several years ago, according to a witness cited in a court document…"
China approves testing of experimental SARS vaccine on humans, CBC News, Jan 20, 2004 (no longer available)
"The Chinese volunteers chosen as subjects for an experimental SARS vaccine are healthy adults aged 20 to 50 who have tested negative for the virus, and they're being warned their mission could be risky, state television said Tuesday…"
EU directive may harm medical research – scientists, Reuters, Jan 20, 2004 (no longer available)
"Thousands of European scientists have signed a petition against a European Union directive aimed at increasing the scrutiny of clinical trials, saying new red tape could smother independent medical research…"
EU Directive on good clinical practice in clinical trials
Ernest Hendon, 96, participant in Tuskegee study, dies, New York Times, Jan 19, 2004 (no longer available)
"Ernest Hendon, the last survivor of the infamous Tuskegee syphilis study, died Friday, said Fred Gray, a lawyer who represented victims of the study in a federal lawsuit…"
Week of January 12, 2004
Pollster told to be in court, Modesto Bee, Jan 15, 2004
"A judge Wednesday ordered a university professor at the center of a survey scandal to appear at accused killer Scott Peterson's next court date…"
Statement Regarding Allegations of Research Misconduct, California State University Stanilaus, Jan 14, 2004
"California State University, Stanislaus has begun its formal inquiry into circumstances surrounding a sociology class survey related to the Scott Peterson case…"
Prosecution seeks Peterson pollsters, Modesto Bee, Jan 10, 2004
"Prosecutors announced Friday that they want to speak with unidentified university students who said they fabricated telephone survey data on the Scott Peterson double-murder case…"
IBM starts information-based medicine unit, IDG News Service, Jan 14, 2004
"IBM Corp. has started a new business unit focused on information-based medicine in its life sciences division with the aim of helping customers integrate health-care data, including research, genetic tests, patient medical records, clinical trials records and medical images…"
No legal protection for clinical trials, Mmegi, Jan 14, 2004
"Botswana has no legal provision to protect the rights of volunteers involved in clinical trials, an HIV/AIDS activist has said…"
Week of January 5, 2004
Judge decides Pentagon can resume anthrax vaccinations, New York Times, Jan 8, 2004 (subscription required; archived, payment required)
"A federal judge on Wednesday lifted his injunction halting the military’s mandatory anthrax vaccination program, and the Pentagon swiftly ordered the resumption of shots for all its personnel except the six anonymous people who brought the suit…"
Health News India: Law soon to protect HIV vaccine trial participants, New Kerala, Jan 7, 2004 (no longer available)
"India will soon be enacting a law to give adequate protection to participants undergoing clinical trials of a new HIV vaccine…"
Collaboration with the FDA promising but problematic, Canadian Medical Association Journal, Jan 6, 2004
"The recent Canada-US agreement to share pharmaceutical regulatory information may be a sensible way to pool resources but has some potential problems, says an expert in pharmacology…"
The tribulations of community-based trials, Canadian Medical Association Journal, Jan 6, 2004
"Doctors and the medical profession are facing some troubling issues as clinical trials sponsored by the pharmaceutical industry migrate from academic settings into the community…"
Drop in hormone therapy use shows physicians heed clinical trial findings, Stanford researchers say, EurekAlert, Jan 6, 2004
"The dramatic drop in prescriptions for postmenopausal hormone replacement therapy after the risks of long-term estrogen/progestin use were announced suggests physicians respond more readily to new clinical evidence than previously observed, say researchers at the Stanford University School of Medicine…"
Placebo-controlled clinical trials put children with asthma at risk, EurekAlert, Jan 5, 2004
"Enrolling children with asthma in the placebo arm of a clinical trial is common, harmful and ethically unjustified argue researchers from the University of Chicago and the National Institutes of Health (NIH) in the January 2004 issue of Pediatrics…"
Week of December 29, 2003
Secretary’s Advisory Committee on Human Research Protections (SACHRP), December 2003 meeting presentations and public comments, Dec 30, 2003
Biotech – A coming boom or bust? Business Week, Dec 29, 2003
US scientists’ deals with drug firms under review, LA Times carried by Yahoo News, Dec 29, 2003 (no longer available)
Week of December 23, 2003
US asks judge to lift his ban on Pentagon’s anthrax vaccination program, New York Times, Dec 27, 2003 (subscription required; archived, payment required)
Defense dept halts anthrax vaccinations, New York Times, Dec 24, 2003 (subscription required; archived, payment required)
How genomics propelled a malaria drug to clinical trials, Genome News Network, Dec 24, 2003
Top ten scientific advances of 2003, Boston Globe, Dec 23, 2003
The ghost of medical atrocities: what’s next, after the unveiling? New York Times, Dec 23, 2003 (subscription required; archived, payment required)
Week of December 15, 2003
How the drug industry is branding itself with bioethics, Slate, Dec 15, 2003
Week of December 8, 2003
UK may ban antidepressants for children, CNN, Dec 10, 2003
NIH to launch ethics review, The Scientist, Dec 10, 2003
Debate on human cloning is put off by UN for a year, New York Times, Dec 10, 2003 (subscription required; archived, payment required)
Survey finds many NIH scientists also hired by drug firms, Baltimore Sun, Dec 8, 2003 (no longer available)
Week of December 1, 2003
EU to fund stem cell research despite ethics split, Forbes, Dec 3, 2003 (no longer available)
China to give first SARS vaccine to people, New Scientist, Dec 3, 2003 (no longer available)
Drug firms pay doctors to sign “independent” clinical trials, Edmonton Journal, Dec 1, 2003 (no longer available)
Week of November 24, 2003
Protecting genetic resources, People’s Daily, Nov 25, 2003
Week of November 17, 2003
Uniform conflict rules needed, The Scientist, Nov 19, 2003

GAO Report: University Research: Most Federal Agencies Need to Better Protect Against Financial Conflicts of Interest, Nov 14, 2003

NU panel to investigate prof’s research tactics, Daily Northwestern, Nov 18, 2003
Week of November 10, 2003
Experts criticize US stem cell decision, Globe and Mail, Nov 12, 2003 (free registration required; archived, payment required)
Drugs of 4 patients subbed without OK. Switch at Fuller mental health clinic aimed at research, Boston Globe, Nov 10, 2003
IU’s swift action may save research efforts, Indianapolis Star, Nov 10, 2003 (no longer available)
Week of November 3, 2003
A good test subject is hard to find, Bozeman Daily Chronicle, Nov 5, 2003
SARS vaccine trial could start in a few months, United Nations News, Nov 5, 2003 (no longer available)
Shanghai to get new Pfizer clinical trial center, China Daily, Nov 5, 2003
Research suspended at IU South Bend, Indianapolis Star, Nov 4, 2003 (no longer available)
Off label drug use growing. Part One of a Three-Part Series. St. Paul Pioneer Press, Nov 2, 2003 (free registration required)
Off label drug use. Part Two of a Three-Part Series: Samples pave way for Rxes. St. Paul Pioneer Press, Nov 3, 2003 (free registration required)
FDA oversight of “off-label” drug use wanes. Part Three of a Three-Part Series. St. Paul Pioneer Press, Nov 4, 2003 (free registration required)
Additional series resources and information, St. Paul Pioneer Press, Nov 5, 2003 (free registration required)
Week of October 27, 2003
Draft code of contact for medical editors, British Medical Journal, Nov 1, 2003 (comments solicited)
Comments received to date
The National Institutes of Health (NIH) Seeks Public Comment on the “NIH Strategic Research Plan and Budget to Reduce and Ultimately Eliminate Health Disparities, Fiscal Years 2002-2006”, NIH News, Oct 30, 2003
Strategic Research Plan and Budget…..
MPs vote to allow use of embryos in research, Globe and Mail, Oct 29, 2003 (free registration required; archived, payment required)
NIH questions researchers on AIDs grants. NIH Questions Researchers About Grants on AIDS, Sexual Practices After Republicans Seek Review. ABC News, Oct 28, 2003 (no longer available)
FDA intensely reviews depression drugs, New York Times, Oct 28, 2003 (subscription required; archived, payment required)
Human stem cell work may start in 5 years. Pioneers say progress under way in stem cell research; Human trials may start in 5 years, ABC News, Oct 27, 2003 (no longer available)
Fogarty International Center announces first awards for research program in stigma and global health, NIH News, Oct 27, 2003
Stigma and Global Health Research Program, Fogarty International Center
Week of October 20, 2003
HHS awards $14 million to support bioethics research center at Tuskegee University, NIH News, Oct 24, 2003
Tuskegee University National Center for Bioethics
Amendment of Statement of Organization Functions and Delegations of Authority for the Office for Human Research Protections, Federal Register, Oct 22, 2003
A tough lesson on medical privacy. Pakistani transcriber threatens UCSF over back pay.  San Francisco Chronicle, Oct 22, 2003
Who enrolls in clinical oncology trials? EurekAlert, Oct 21, 2003
Cancer-drug trial reports deaths; Cell Therapeutics cuts dose, Seattle Times, Oct 21, 2003
Heroin experiment “benefits” everyone. The clinical trials aims to keep drug users off the streets, Vancouver Sun, Oct 20, 2003 (no longer available)
Week of October 13, 2003
Bush’s advisors on biotechnology express concern on its use, New York Times, Oct 17, 2003 (subscription required; archived, payment required)
The President’s Council on Bioethics Web Site
Council’s Report: Beyond Therapy: Biotechnology and the Pursuit of Happiness
Chirac urges global ethics law, The Scientist, Oct 15, 2003
Senate sends to house a bill on safeguarding genetic privacy, New York Times, Oct 15, 2003 (subscription required; archived, payment required)
Genetic Information Nondiscrimination Act of 2003 (Enter S.1053.ES for Bill Number)
Modeling a “virtual” patient, The Scientist, Oct 15, 2003
US banned fertility method tried in China, Washington Post, Oct 14, 2003 (archived, payment required)
Seminar hears calls for openness and international engagement on ethics in medical research, Cordis News, Oct 14, 2003
Court revives Pfizer suit on Nigeria study, Washington Times, Oct 13, 2003 (no longer available)
Week of October 6, 2003
National Academy proposes scientists self-police, The Scientist, Oct 9, 2003
National Academy of Sciences Press Release, Oct 8, 2003
Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma
Victims of Harvard projects, China Daily, Oct 8, 2003
Life as a guinea pig, Boston Globe, Oct 7, 2003
AIDS vaccine still elusive, but optimism creeps in, CNN, Oct 7, 2003 (no longer available)
HHS Secretary Tommy Thompson announces $1 million grant as part of partnership with National Health Museum, DHHS News Release, Oct 7, 2003
National Health Museum Web Site
Minority children: Over- or underrepresented in medical research?, EurekAlert, Oct 6, 2003
Week of September 29, 2003
Research tested faith, citizenship, Baltimore Sun, Oct 5, 2003 (archived, payment required)
NIH announces $2b initiative to aid research, Boston Globe, Oct 1, 2003
NIH Roadmap Website
Researchers look for ways to protect privacy of electronic information, Stanford Report, Sept 30, 2003
Week of September 22, 2003
Academic clinical research is under threat from the EU, EurekAlert, Sept 25, 2003
Health of independent clinical trials in danger, EurekAlert, Sept 24, 2003
California backs new stem cell research measures, Reuters, Sept 24, 2003 (no longer available)
For some, untested drug is a last chance, Boston Globe, Sept 23, 2003
European cancer patient coalition formed, Reuters, Sept 23, 2003 (no longer available)
Can ET phone home? The brave new world of university surveillance, Academe Online, September/October 2003
Week of September 15, 2003
AIDS Vaccine 2003: An African Perspective, Voice of America, September 20, 2003 (no longer available)
Paralyzed Mesa man faults VA experiment, Arizona Republic, September 17, 2003 (no longer available)
Week of September 8, 2003
Dalai Lama visit provides a subject for scientists, Boston Globe, September 12, 2003
Red tape “harming cancer patients”, BBC News, September 11, 2003
Young adults overlooked in cancer treatment, doctors say, Forth Worth Star Telegram, September 8, 2003 (no longer available)
Minutes, July 22, 2003 Inaugural Meeting of the Secretary’s Advisory Committee on Human Research Protections
Week of September 1, 2003
HHS announces new regional centers for biodefense research, NIH News, September 4, 2003
Building African research capacity, The Scientist, September 4, 2003
Europe Developing Countries Clinical Trials Partnership
Science journals do ethics check, Wired News, September 3, 2003
Week of August 25, 2003
Bush wants peer review for rules, Seattle Times, August 30, 2003 (free registration required; archived, free access)
The Consent Gap. Patients and their families aren’t always told when a doctor decides to include them in research, Newsday, August 26, 2003 (no longer available)
Week of August 18, 2003
Congress weighs drug comparisons, New York Times, August 24, 2003 (subscription required; archived, payment required)
IBM looks to genetics to map a new business, New York Times, August 21, 2003 (subscription required; archived, payment required)
Most drugs never tested for safety in children, Boston Globe, August 20, 2003 (archived, payment required)
Good science, good PR. Estonia looks to make its mark by building one the world’s biggest DNA databases, Boston Globe, August 19, 2003
Week of August 11, 2003
Almost half of all faculty on Institutional Review Boards have ties to industry, EurekAlert, August 14, 2003
Cloning yields human-rabbit hybrid embryo, Washington Post, August 14, 2003 (archived, payment required)
Guidance on the use of expedited review procedures, OHRP, August 11, 2003
Week of August 5, 2003
Debate resumes on the safety of depression’s wonder drugs, New York Times, August 7, 2003 (subscription required; archived, payment required)
Researchers compile “atlas” of the brain, Reuters Health, August 8, 2002 (no longer available)
Lawsuit filed over 1939 stuttering study, New York Lawyer, August 6, 2003
Week of July 28, 2003
Brainstorm to breakthrough: A surgical procedure is born, New York Times, August 4, 2003 (subscription required; archived, payment required)
Conference to confront ethical, safety issues in designing medical research, Newhouse News Service, July 30, 2003
Panel proposes changes for National Institutes of Health, New York Times, July 30, 2003 (subscription required; archived, payment required)
Week of July 21, 2003
US Senate backs pediatric drug testing, Reuters, July 24, 2003 (no longer available)
Group blasts “unethical” surveys. Med schools coerce participation, it says, San Diego Tribune, July 23, 2003 (archived, payment required)
Biotechs' lobbying begins to pay off. Victories pile up as spending on political causes soars, Washington Post, July 22, 2003
Your “Natural” Role: Boss or Worker Bee?, ABC News, July 22, 2003 (no longer available)
Biovail says research and others say conflict, The Globe and Mail, July 22, 2003 (free registration required; archived, payment required)
Week of July 14, 2003
Boost from the FDA, San Diego Union-Tribune, July 15, 2003
Week of July 7, 2003
Gates aims billions to attack illnesses of world’s neediest, New York Times, July 13, 2003 (subscription required; archived, payment required)
Lung study can resume – with fuller review of risks, San Francisco Chronicle, July 8, 2003
Hopkins asks patients to waive certain privacy rights, ABC, July 7, 2003 (no longer available)
Week of June 25, 2003
Gates Foundation urges joint effort to create AIDS vaccine, Seattle Times, June 27, 2003 (free registration required; archived, free access)
Firm’s anthrax drug cleared for human tests, Washington Post, June 25, 2003
Pharmacogenomics: Great potential, great debates, IDG News Service, June 25, 2003
Week of June 16, 2003
VA Research.  Actions insufficient to further strengthen human subjects protections, US General Accounting Office, June 18, 2003
AMA says use of stem cells for biomedical research is consistent with medical ethics, American Medical Association News Release, June 17, 2003 (see #8 under Announcements)
Week of June 9, 2003
NHGRI Study May Help Scientists Design Safer Methods for Gene Therapy, NIH News Release, June 12, 2003
Aspirin as effective as Ticlopidine in African American Stroke Prevention, EurekAlert, June 10, 2003
Week of June 2, 2003
Assessing the risks, benefits of clinical trials, AARP Bulletin, June 2003
Fraud research grants increase, The Scientist, June 5, 2003
NIH RFA Research on Research Integrity, Issued May 30, 2003
Week of May 26, 2003
Howard U. plans genetic database, Washington Post, May 28, 2003
Little children suffer in search for cures, USA Today, May 29, 2003

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