Three Questionable FDA policies: drug factory inspection rules/ clinical trials/ Paxil ads Thu, 22 Aug 2002 Three news items highlight questionable FDA policies that are in conflict with consumer health interests. 1) Poor quality control standards in American drug and vaccine manufacturing plants is a disgrace. The Associated Press reports…
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of…
Jeffrey Drazen editor NEJM Turns Activist on Drug Trials Thu, 26 May 2005 Journal editors, one by one are trying to retrieve the integrity of their publications, at last recognizing that the pharamaceutical industry is a corrupting factor in medical research and the information disseminated about medicine. Jeffrey Drazen who…
War hero’s death in clinical trial follows years of FDA neglect – Bloomberg News Thu, 10 Nov 2005 Bloomberg News reports that a decorated veteran of the Vietnam war was killed in 2002, in a clinical drug trial at the FABRE Research Clinic in Houston, Texas. The FDA had found…
Additional information as of late Wed Oct 19: Although I was assured that attendance for a presentation by Dr. David Healy (at Columbia University School of Public Health on Oct. 20 at 12:30) would be open to the public, a problem seems to have emerged after an AHRP Infomail about…
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 15a, 2002 Harm to Alzheimer ExperimentalPatients FYI ABC reports that Bob Helms, the self-described humanguinea pig, has written a book about his experience and observations about…
“Black Hole” of medical research–Negative Results Don’t get Published – JAMA, WSJ Sat, 5 Jun 2004 “No one likes bad news. But in science, there is an ethical imperative to publish research, even if the findings aren’t what the researcher had hoped for.” The New York Times, which tends to…
October 29, 2001 FYI Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in…
Debate: When Is it Ethical / Unethical to Use Placebo? – PLoS Wed, 12 Oct 2005 A debate in PLoS Medicine addresses the question: Should researchers test an experimental treatment against placebo to prove the superiority of the new treatment? The ethical standards for research adopted by the World Medical…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
