Guidant Didn’t Disclose a Flaw in Defibrillator for 3 Years_NYT / FDA Wrong on Crestor Safety Tue, 24 May 2005 The New York Times reports that the maker a a heart defirillator knew for 3 years about a malfunction and failed to inform physicians about It because the company “had…
Advisory Committee tells FDA: strengthen warnings on SSRI drug labels now Wed, 4 Feb 2004 On February 2, more than 60 families and children from all across America testified at a public FDA advisory committee hearing describing (in 2 minutes) how their children suffered drug-induced harm after being prescribed an…
Unhealthy Ethics? The Price of NIH Credibility_ Editorials: WashPost / Los Angeles Times Mon, 11 Apr 2005 Compare and contrast two editorials that focus on the new conflict of interest rules that were adopted by Dr. Elias Zerhouni, director of the National Institutes of Health, to rein in the corrupting…
FDA Official Admits ‘Lapses’ on Vioxx – FDA Didn’t Heed Warnings on Dangers of MS Drug Wed, 2 Mar 2005 As the Senate committee on Health, Education, Labor and Pensions prepares for the second day hearing about FDA’s performance, one hopes that the committee will follow up Tuesday’s hearing with…
Time for a Drug Test Registry_Marcia Angell_Why NIH is Not Up to the Task Fri, 13 Aug 2004 The uncovering of concealed, unpublished evidence showing that children suffered harm in antidepressant drug trials, has led to a rude public awakening. Selective reporting of clinical trial data has become “standard practice”…
Psychiatry and Preschoolers Tue, 1 Jul 2003 There was a time that doctors followed the precautionary “do no harm” principle when prescribing drugs. But the practice of medicine has changed radically as physicians have increasingly become financially tied to the pharmaceutical industry. Among psychiatrists it is difficult to find one…
Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…
NIH AIDS Research Chief Rewrote Safety Report – AP Wed, 15 Dec 2004 John Solomon of The Associated Press continues his documented expose of the inner workings of the AIDS Division of theNational Institutes of Health (NIH). At the same time that the Los Angeles Times and Congfressional hearings focused…
FDA Approves Lilly’s Growth Hormone for Healthy Children Mon, 28 Jul 2003 The FDA has approved Eli Lilly’s injectable human growth hormone (hGH) therapy, Humatrope, for healthy children who are short but have no hormonal deficiency. Lilly claims that its trials in 300 healthy short children resulted in an increase…
Science & Ethics Hold Up EPA Nomination: pesticide experiment draws fire Fri, 08 Apr 2005 The Los Angeles Times reports that Senator Bill Nelson of Florida is equally outraged about the Environmental Protection Agency pesticide experiment that would expose 60 poor babies to pesticides to study how much harm they…
FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning Fri, 18 Mar 2005 It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report. The Los…
Two actions by the FDA last week demonstrate where the agency’s priority lies—and that priority is NOT to protect public safety, NOT to protect children’s safety. FDA’s priority—as demonstrated by its actions—is approval of new drugs or approval for expanded even dubious uses of patented drugs.
