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Context of 'Early January 2004: FDA Official Bars Agency Scientist From Presenting Report on Potential Link Between Antidepressants and Suicide'

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Pfizer attorney Malcolm Wheeler calls FDA chief counsel Daniel E. Troy requesting that the agency intervene in a lawsuit filed against the company. The lawsuit alleges that Zoloft, an antidepressant drug manufactured by Pfizer, caused Victor Motus of California to kill himself on November 12, 1998. It also says that the drug company should have warned physicians that Zoloft might cause suicidal thoughts in some people. On September 3, the FDA files a brief stating that the agency’s scientists have found no evidence that antidepressants cause suicidal thoughts. Furthermore, the FDA argues, if Pfizer had warned doctors of such a link, it would have been a violation of the law because all warnings must first be vetted by the FDA. According to Troy, the agency has “absolute control over the label.” This position, notes one of the plaintiff attorneys in the Pfizer case, contradicts arguments that Troy made when he was practicing in the private sector. Before he had argued that the agency’s rulings were arbitrary and capricious. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Pfizer, Malcolm Wheeler

Timeline Tags: US Health Care

FDA medical officer Andrew D. Mosholder finds evidence that antidepressant drugs such as Paxil, Zoloft, and Effexor may increase the risk of suicidal thoughts in children. Agency officials praise his work but express a lack of confidence in the data. The FDA takes no action. [Washington Post, 9/24/2004]

Entity Tags: Andrew Mosholder, US Food and Drug Administration

Timeline Tags: US Health Care

Britain’s Department of Health advises doctors treating depressed children to prescribe only Prozac. Other antidepressants like Zoloft, Paxil, Luvox, Effexor, Celexa, and Lexapro should be avoided, it warns, because of a potential link between these drugs and suicidal and hostile behavior. [BBC, 12/10/2003; New York Times, 12/16/2003] The FDA takes no action in the US, and continues to sit on a study by one of its own scientists (see September 2003) that links the drugs to suicidal thoughts in children. [Washington Post, 9/24/2004]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

Russell Katz, director of the FDA’s division of neuropharmacological drug products, informs medical officer Andrew Mosholder that he will not be permitted to present his report on the suicidal side effects of Paxil, Zoloft, and certain other antidepressants. Mosholder—who believes the drugs may increase suicidal tendencies in children (see September 2003)—was scheduled to report his findings at an FDA advisory hearing on February 2. Katz reportedly tells Mosholder his report is biased. When the San Francisco Chronicle asks about this decision, Anne Trontell, deputy director of the agency’s Office of Drug Safety, says Mosholder can’t present the report because it has not yet been “finalized.” [San Francisco Chronicle, 2/1/2004]

Entity Tags: Anne Trontell, Russell Katz, Andrew Mosholder

Timeline Tags: US Health Care

FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. [Washington Post, 10/8/2004] When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” [US Congress, 11/18/2004 pdf file] In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

Entity Tags: John Jenkins, David Graham

Timeline Tags: US Health Care

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