At FDA, Changes In Name Only–Agency Puts Business interests Above Safety Fri, 30 Sep 2005 The sudden resignation of FDA Commissioner, Lester Crawford, after just two months in office, has prompted a bipartisan Senate investigation and requests both by the Senate committee HELP and by congressman Maurice Hinchey (NY) and…
Ct. Attorney General Files Petition with FDA Seeking Warning on Drug – NYT Sat, 7 May 2005 Connecticut’s Attorney General, Richard Blumenthal, is to be commended for filing a citizen’s petition that essentially asks the FDA to do its job of protecting the public by issuing warnings about the potentially…
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
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…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children Being proactive is generally a good idea. But in the absence of a definitive outbreak it is difficult to justify exposing pediatric patients to potential risks such as neurologic complications which may not show up for years….
27 April 2004 Background Information Representative, U.S. The Honorable Mr. Joe Barton, United States House of Representatives. Washington DC. Representative, U.S. The Honorable Mr. James Greenwood, United States House of Representatives, Washington DC. Number of US Citizens at Risk to SSRIs This letter is to advise you that there is…
September 3, 2002 Columbine shooting victim sues Solvay Pharmaceuticals – Insight Magazine FYI Insight Magazine reporter, Kelly Patricia O’Meara, reports in (below) that 19- year old Mark Taylor, a victim of the shooting spree at Columbine high school in 1999, spent nearly two months in the hospital plus 3 years…
Wed, 04 May 2005 Researchers Tested AIDS Drugs on Children, Associated Press On March 10, 2004, The Alliance for Human Research Protection filed a complaint with the FDA and the federal Office of Human Research Protection about a series of AIDS drug experiments conducted on New York City children in…
Pfizer Acknowledges It Failed to Reveal Celebrex cardiac risk found in 1999 trial Tue, 1 Feb 2005 The New York Times reports: “Responding to the Vioxx withdrawal [Sept. 30, 2004], Pfizer said in October that no completed study had ever shown any increased heart risks related to Celebrex. Then, in…
Tamiflu Cited in 2 Teen Deaths – Global Plan for Influenza Action – Lancet Monday, November 14, 2005 Japanese newspapers report that two teenage boys – one 14 the other 17 – died after taking one dose of the antiviral drug, Tamiflu, the drug being stockpiled in the event that…
Major Drug Effectiveness Review Found “Little Evidence” that ADHD drugs are safe or effective Tue, 13 Sep 2005 On paper, drug manufacturers MUST demonstrate with scientific evidence that a drug is safe and effective–if they want to gain to gain FDA approval. The burden of proof is on the manufacturer….
Pfizer CEO earned $16 milion-72% Increase / V-P Tells Congress How to Save $37.8 billion in cost of drugs Thu, 10 Mar 2005 In his February 16 testimony before the Senate Committee on Health, Education, Labor and Pensions, Dr. Peter Rost, Pfizer V-P for Marketing, said: “Every day Americans die…
