FDA Official Admits ‘Lapses’ on Vioxx – FDA Didn’t Heed Warnings on Dangers of MS Drug

FDA Official Admits ‘Lapses’ on Vioxx – FDA Didn’t Heed Warnings on Dangers of MS Drug Wed, 2 Mar 2005 As the Senate committee on Health, Education, Labor and Pensions prepares for the second day hearing about FDA’s performance, one hopes that the committee will follow up Tuesday’s hearing with…

Pfizer Acknowledges It Failed to Reveal Celebrex cardiac risk found in 1999 trial

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…

BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception

BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sun, 3 Oct 2004 BBC-Panorama is airing its third in a series of investigative reports about the betrayal of trust in psychiatry, drug manufacturers and government regulators. The first program, The Secret of Seroxat, aired October 13, 2002, revealed…

Credibility Crisis: Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA

Credibility Crisis:Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA Thu, 16 Dec 2004 A credibility crisis in medical research is smoldering: like the Enron accounting scandal, the prescription-drug debacle is a matter of systemic corruption, including gross and widespread failure by the regulatory process. Unlike…

At FDA, Graham is still the whistle-blower – USA Today

At FDA, Graham is still the whistle-blower – USA Today Thu, 17 Nov 2005 On Nov. 18, 2004, Dr. David Graham, FDA’s associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA’s “profound regulatory failure” to protect the public against lethal prescription…

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…

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FDA Smoke & Mirrors Musical Chairs

FDA Smoke & Mirrors Musical Chairs Wed, 16 Feb 2005 Amidst widespread public criticism of the FDA’s role as facilitators in the marketing of lethal drugs that killed thousands of people, the Administration made several announcements incorporating terminology (such as: “we’re in an era of openness” “transparency”). But politically correct…

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…

Paxil Protest at GSK US headquarters Sept. 26–Sept. 28

Paxil Protest at GSK US headquarters Sept. 26–Sept. 28 Sun, 18 Sep 2005 Families and victims who have suffered harm from SSRI antidepressants are heading for Philadelphia from the US and Canada for a “Paxil Protest.” Date: September 26 through Sept. 28. Place: GlaxoSmithKline US headquarters in Philadelphia The organizer of this event is…

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 Regulators Accused of Trying to Quash Testimony About Cardiac Risks of Painkillers – NYT

FDA Regulators Accused of Trying to Quash Testimony About Cardiac Risks of Painkillers – NYT Sat, 12 Feb 2005 A New York Times front page report announces that President Bush will veto any limits on the Medicare prescription drug giveaway. The administration is adamant about transfering $724 billion in taxpayer…