FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Avonex Warning

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…

Analysis of S. 1873 – The Biodefense and Pandemic Vaccineand Drug Development Act of 2005 – Effrem

Analysis of S. 1873 – The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 Karen R. Effrem, MD Alliance for Human Research Protection Board of Directors www.ahrp.org INTRODUCTION: This bill seriously endangers, if not completely undermines, the democratic process and the rule of law. It will absolutely destroy…

FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT

FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…

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NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ

NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ Sun, 27 Jun 2004 Under fire from Congress with evidence of NIH staff engaging in secret outside contracts and consultancies, NIH Director, Dr. Elias Zerhouni, turned a corner. He acknowledged the problem at a hearing (June 22) of…

Will NIH Ban on Consulting Deals with Drug Firms Set an Ethical Example? LAT / NYT

Will NIH Ban on Consulting Deals with Drug Firms Set an Ethical Example? LAT / NYT Wed, 2 Feb 2005 The Los Angeles Times, whose investigative reports about conflicts of interest at the National Institutes of Health, shook the foundations of NIH by prying open the vaults that contained secret…

Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report

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…

NIH Chief Calls for Ethics Summit to address Conflicts of Interest in Medical Research – LA Times

NIH Chief Calls for Ethics Summit to address Conflicts of Interest in Medical Research – LA Times Mon, 14 Feb 2005 AHRP applauds Dr. Elias Zerhouni, director of the National Institutes of Health, for stepping up to the plate as a leader of an agency that will award about $21…

Public Servant or Private Marketer? NIH Seeks Inquiry of Alzheimer’s researcher conflicts of interest

NIH: Public Servant or Private Marketer? NIH Seeks Outside Inquiry of Alzheimer’s researcher conflicts of interest – LAT Mon, 31 Jan 2005 A year after the Los Angeles Times published its first an in-depth investigative report documenting in detail evidence of major conflicts of interest by top scientists at the…

Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT

Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT Sun, 14 Mar 2004 Former Director of the National Institutes of Health, Harold Varmus, MD, appeared before a blue ribbon panel convened by his former agency, ostensibly to shed light on conflict of interest at…

Hemophiliacs File Suit Against Bayer for selling Tainted Blood product

Hemophiliacs File Suit Against Bayer for selling Tainted Blood product Tue, 3 Jun 2003 The Los Angeles Times reports that two weeks after The New York Times reported that Bayer documents reveal that the company sold tainted blood-clotting medicine for hemophiliacs that carried a high risk of transmitting AIDS to…

FDA Suspends ADHD Drug Safety Study-Approves Risperdal for Autistic Children Without Public Hearing

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.