Analysis of 94 OHRP Letters of Determination, July 1, 2000 to January 31, 2001 Research Compliance Note. Thomas Dalglish, JD, PhD * The views expressed in the ‘Research Compliance Note’ below are the personal opinions of the author, do not reflect any official position of the University of Washington, and…
Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs Thu, 18 Nov 2004 The Associated Press reports that at a Congressional hearing today, Dr. David Graham a drug safety expert at the FDA told the Senate Finance Committee that the public is “virtually defenseless” if another medication such as Vioxx…
Forbes: Judgment Day for the FDA, Pfizer Wed, 9 Feb 2005 On Feb. 16-18 COX-2 Inhibitor Safety Issues will be the focus of an FDA Advisory Committee and (simultaneously) the European Medicines Agency (EMA). The entire drug industry will be watching with bated breath. Which causal explanation will be offered…
Cong Hinchey PRESS CONFERENCE Re: Drug Co. Influence on FDA Sat, 10 Jul 2004 New York Congressman Maurice Hinchey (House Appropriations Committee) is holding a press conference on Tuesday, July 13, 2004, at 10:30 AM to address issues of concern about undue influence by drug manufacturers on FDA policy and…
MEMORANDUM Date: June 10, 2002 From: THE ALLIANCE FOR HUMAN RESEARCH PROTECTION Re: Opposition to AB 2328 To: Members of the California Health and Human Services Committee and Staff: Senator Deborah Ortiz (Chair), Mr. John Miller Senator Ray Haynes (Vice Chair), Ms. Debbie Rogers Senator Jim Battin, Ms. Katie Tinney…
Paxil induced suicides in US quantified_Glaxo Faces criminal action in UK over “suicide” pills_Times Mon, 7 Jun Law enforcement is finally catching up with drug companies who, for years, concealed evidence of a drug-related suicide risk for some children and adults who take an antidepressant. The law requires the companies…
’91 Merck Memo Warned of Mercury in Baby Vaccines – LAT Tue, 8 Feb 2005 The Los Angeles Times reports that a 1991 internal Merck memo obtained from a whistleblower by James Moody, a Washington lawyer who works with parent groups on vaccine safety issues, provides the “first hard evidence…
Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT Mon, 26 Jul 2004 The New York Times reports that the Bush administration is actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers. The administration argues that “if a local judge…
Letter from David Healy, MD to Peter J. Pitts Executive Summary of suicidal evidence not addressed by FDA In the light of Traci Johnson’s death on February 7th 2004, will FDA obtain Pfizer’s entire folder on the 1982 Hindmarch study in which healthy volunteers were given Zoloft, and make a…
“Black Hole” of medical research–Negative Results Don’t get Published – JAMA, WSJ Sat, 5 Jun 2004 “No one likes bad news. But in science, there is an ethical imperative to publish research, even if the findings aren’t what the researcher had hoped for.” The New York Times, which tends to…
FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks Mon, 29 Aug 2005 Related link: FDA Amicus Curiae–Kallas–claims FDA infallibility pre-empts state safety laws (warning: large 1.6 MB file) A federal judge in Utah has asked the FDA to explain its position as it relates…
GlaxoSmithKline CEO: “We had to absorb a number of hits” Mon, 16 Feb 2004 Antidepressant drug safety issues are beginning to have a financial impact. Dow Jones reports: “GlaxoSmithKline PLC said its net income fell 6% in the fourth quarter, hurt by previously announced legal costs related to its anti-inflammatory…
