Drugmaker Eli Lilly yesterday launched a public relations campaign to counteract allegations made in the British Medical Journal that it had covered up documents linking its Prozac (fluoxetine) antidepressant with suicide attempts and violence [[04/01/05c]].
In answer to allegations published in the BMJ in late 2004 that the US Food and Drug Administration is to review classified documents that disappeared during a controversial lawsuit on the issue 10 years ago, Lilly has now posted a detailed explanation of those papers on its website. It has also published an open letter to patients in leading US newspapers to state its case and respond to “inaccurate statements circulating in the news media.”
The BMJ, quoting the FDA’s Dr. Richard Kapit, maintained that the papers were not presented in a 1994 trial between Lilly and victims of a 1989 massacre in Kentucky that left eight people dead and 12 injured. The gunman was taking Prozac and later committed suicide.
Sidney Taurel, Lilly’s chief executive, said: “It is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators.” The company also said that adverse event data reported by the BMJ – which led to media reports suggesting that Prozac is 12 times more likely to cause suicide than older antidepressants – are a prime example of misusing statistical information without providing scientific context and are not supported by clinical trial data. It also claims that the data were initially presented in 1991 to an FDA advisory committee, which voted unanimously in support of Prozac’s safety.
Lilly said that the BMJ’s actions had “needlessly spread fear among patients who take Prozac”, and repeated its call for the BMJ to make the documents in question available to the media and other interested parties.
Prozac was once Lilly’s biggest-selling drug, but has slipped down the rankings now that it is subject to generic competition. Lilly recently launched a new antidepressant, Cymbalta (duloxetine hydrochloride), which is expected to be a major growth driver for the US company [[05/01/05b]].
