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Context of 'September 2003: FDA Scientist Finds Evidence of Link between Antidepressants and Suicidal Tendencies'

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Vice President Dan Quayle, chairman of the President’s Council on Competitiveness, and Louis Sullivan, secretary of health and human services, announce the FDA’s new policy on the regulation of genetically engineered foods. In the policy statement that is published three days later, the FDA will say it has determined that genetically modified (GM) foods are “substantially equivalent” to conventionally grown foods and therefore will not be subject to any special regulations. The agency justifies its position saying that assessments concerning the safety of food products should be based on the characteristics of the food product and not on the methods used to develop that product. [US Food and Drug Administration, 5/29/1992 pdf file] Specifically addressing the issue of labeling for GM foods, the May 29 statement will read: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. For this reason, the agency does not believe that the method of development of a new plant variety… would… usually be required to be disclosed in labeling for the food.” Labeling would only be required in special cases, the FDA says. For example, if a genetically engineered tomato contains a peanut protein that is a proven allergen, a label will be needed. [US Food and Drug Administration, 5/29/1992, pp. 22991 pdf file] In their statement to the press, Sullivan says that biotechnology promises to develop new food products “that are tastier, more varied, more wholesome, and that can be produced more efficiently.” Quayle’s council played a key role in expediting the development of the policy. [Food and Drug Administration, 5/26/1992] Quayle explains that the policy will ensure the competitiveness of US firms. “The reforms we announce today will speed up and simplify the process of bringing better agricultural products, developed through biotech, to consumers, food processors, and farmers,” he says. “We will ensure that biotech products will receive the same oversight as other products, instead of being hampered by unnecessary regulation.” [New York Times, 1/25/2001]

Entity Tags: Dan Quayle, Louis Sullivan, US Food and Drug Administration

Timeline Tags: Seeds

May 20, 1999: Vioxx Approved by FDA

The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. [US Food and Drug Administration, 2005]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

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

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