Critical GAO Report Belies Safety of Anthrax Vaccine – Insight Mon, 18 Nov 2002 A highly critical 50-page report by the General Accounting Office (GAO) has put into question the safety of the Anthrax vaccine and the credibility of government officials who have withheld information about the vaccine’s serious health…
Research Protection: SCIENCE / Fed Paper Mon, 28 Oct 2002 SCIENCE magazine (below) reported about “the bumpy road” of Dr. Greg Koski’s tenure as director of the federal Office of Human Research Protections (OHRP), and how his resignation is being perceived by some. An article in The FEDERAL PAPER focused…
SSRI’s found to adversely affect newborns during first days of life Sat, 26 Jul 2003 Doctors prescribing antidepressant drugs (SSRIs) to pregnant women may be faced with liability claims, as these drugs are shown to adversely affect unborn and newborn babies’ central nervous system A new report in the Archives…
UK issues ban on second SSRI antidepressant for children Sun, 21 Sep 2003 The UK Observer reports (below) that although antidepressant drugs of the SSRI class have not been approved for children, last year doctors (who are unaware of the severe risks associated with SSRIs) wrote 170,000 prescriptions of antidepressants…
Trial Lawyers Are Taking Aim at the Drug Industry_NYT Sun, 18 May 2003 It appears that trial lawyers will produce the results that government oversight agencies–in particular, the FDA–have failed to do. Namely, to protect the public against an increasing number of unsafe drugs. The pharmaceutical industry whose efforts to…
Suicide in Psych Drug Trials: FDA Orwelian doublespeak – Insight Magazine Date: Mon, 14 Oct 2002 Insight Magazine’s interview with Dr. Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, shows that FDA was caught off guard when Dr. Arif Khan independently analyzed FDA’s data revealing that…
British Medical Journal: Something is rotten at the heart of FDA / Glaxo faces class action suit Sun, 5 Dec 2004 “Something is rotten at the heart of the FDA.” That’s the opening of an editorial in the British Medical Journal. [1] Indeed, there is something rotten at the heart…
FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Fri, 15 Oct 2004 We have won the first battle in a struggle for full disclose of serious adverse drug effects and disclosure of failed clinical trials. Prescribing physicians and the public have…
WSJ: Debate Over Antidepressants: FDA role in suppressing damaging data Tue, 25 May 2004 How were drug manufacturers able to conceal vital evidence of harmful antidepressant drug effects? The answer is becoming clearer by the day: federal regulators and the psychiatrists who tested these drugs in clinical trials are invested…
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…
