Another deadly drug recalled – FDA asks Congress for Power to Dictate Warnings

Another deadly drug recalled – FDA asks Congress for Power to Dictate Warnings Tue, 1 Mar 2005 Public pressure has intensified as FDA’s failure to protect the public from unsafe – even lethal drugs. That failure included the failure to at least warn physicians and the public about severe adverse…

FDA Officials Tried to tone Down Report of 27,000 heart attacks on Vioxx – WSJ – WashPost

FDA Officials Tried to tone Down Report of 27,000 heart attacks on Vioxx – WSJ – WashPost Sun, 10 Oct 2004 The FDA attempted to block a senior medical officer from making his findings known about the lethal hazards of Vioxx: Senator Chuck Grassley stated: “Instead of acting as a…

FDA acknowledges failure to act as defibrillator malfunction increased

FDA acknowledges failure to act as defibrillator malfunction increased: 4,225 failed between 2000–2003 Sat, 17 Sep 2005 The Washington Post reports that the number of failed heart defibrillators is increasing: “William H. Maisel, the Harvard Medical School physician who conducted the FDA study, said the increase is significant and contrasts…

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…

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…

FDA Critics Slam Plan for Safety Reform – Nature

FDA Critics Slam Plan for Safety Reform – Nature Thu, 17 Feb 2005 This is smoke and mirrors and musical chairs. Vera Sharav Alliance for Human Research Protection, New York http://www.nature.com/news/2005/050214/full/050214-11.html Published online: 17 February 2005; | doi:10.1038/news050214-11 FDA critics slam plan for safety reform Emma Marris Calls grow for…

Lies & Broken Promises – Drug firm Websites Fail to Disclose Test Data

Lies & Broken Promises_Drug firm Websites Fail to Disclose Test Data Sun, 9 Jan 2005 One year after PhRMA’s publicized proclamation of its “commitment to transparency” The Boston Globe reviewed pharmaceutical company websites searching for disclosure of clinical trial data. The Globe found that this voluntary approach failed miserably: “Last…

At FDA, Changes In Name Only–Agency Puts Business interests Above Safety

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…