P&G Osteoperosis Drug Trials Spark Major Academic Research Debate Re: Concealed Data Friday, November 25, 2005 Dr. Aubrey Blumsohn: “No self-respecting scientist could ever be expected to publish findings based on data to which they do not have complete and full access.” Sri David Weatherall, Professor Emeritus, Oxford: “People need…
Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…
Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children Wed, 17 Dec 2003 Medscape Medical News reports about passage of the Pediatric Research Equity Act (PREA) which replaces FDA’s Pediatric Rule. The Pediatric Rule was struck down by a Federal court in Oct. 2002 because…
Pharma Efforts to Bar Placebo Responders from Trials – WSJ Fri, 25 Jun 2004 A clinical trial report in The Lancet debunks the value of Aricept, a popular drug prescribed for Alzheimer’s patients. The findings of a three-year placebo controlled trial show that: “Although the patients taking the drug did…
What the FDA Isn’t Telling You – SLATE Date: Tue, 27 Sep 2005 Writing in SLATE, Jeanne Lenzer has uncovered evidence demonstrating FDA culpability in helping drug manufacturers conceal vital, life-saving information from the public. In this case, undisclosed suicides in clinical trials testing Eli Lilly’s drug, duloxetine (trade names:…
Cong Hearing Re: Disclosure Pediatric SSRI Trials Wed, 7 Jul 2004 A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse…
Concealed NIH Review Substantiates Fired Expert’s Concerns – AP Mon, 4 Jul 2005 The Associated Press reports that a 2004 internal report by the National Institutes of Health validates the allegations by Dr. Jonathan Fishbeing, the NIH ethics-safety expert who was fired for reporting unethical and scientifically flawed AIDS resesrch…
Risk Bearing Children February 27, 2001 Would you volunteer your child to be a "risk-bearing" subject in drug experiments? When Jonathan Swift published A Modest Proposal in 18th century Ireland, he offered a sure solution to the country’s hunger and economic ills: The poor could sell their year-old children as…
VA Drug Study Deaths under Criminal Investigation in NY_BNA Thu, 6 Feb 2003 Alexander Otto of the Bureau of National Affairs (BNA) has uncovered a criminal investigation at the VA Medical Center in Albany, NY following the deaths of 5 patients who were inappropriately enrolled in a cancer drug trial….
Fast growing business: Unethical clinical trials in India – Asia Times Tue, 27 Jul 2004 Asia Times reports: “India increasingly emerges as a preferred destination for outsourcing clinical trials – testing of new drugs on humans – the country may also be heading toward providing the greatest source of human…
IOM Committee Considers Prison Research Sun, 24 Jul 2005 Today¹s New York Times Magazine cover story, Planet of the Retired Chimpanzees By CHARLES SIEBERT, reports that chimpanzees who have served as subjects in biomedical research can look forward to being set free in one of 12 specially built chimp sanctuaries…
Concealed Drug Trial Results Mislead Doctors & Put Children’s Lives at Risk – NYT Thu, 22 Jul 2004 The inordinate influence that drug companies wield on government healthcare regulatory policies–through campaign contributions to elected officials and lucrative job offers to public officials–has seriously compromised children’s safety in numerous ways. An…
