Lilly claims that Prozac is a safe drug

Eli Lilly and Company announced its plans to correct inaccurate statements circulating in the news media based on a collection of random papers anonymously sent to the British Medical Journal (BMJ).

The British Medical Journal (BMJ) published an article in its Jan. 1, 2005, issue stating that the FDA has agreed to review confidential Lilly documents that suggest a link between Prozac and suicide attempts and violence. The journal alleged that the documents, given to the BMJ from an anonymous source, went missing during the case of Joseph Wesbecker in 1994. (Related article: Prozac recall expected after emergence of disturbing evidence)

The journal provided 52 pages of documents to Rep. Maurice Hinchey (D-NY), who forwarded them to Lilly on Tuesday, Jan. 4. On Wednesday, Jan. 5, Rep. Hinchey sent a letter to Dr. Lester Crawford, acting commissioner of the FDA, calling for an investigation into this matter. After reviewing the documents, Lilly issued a response on Jan. 4 stating that they reveal no new clinical or scientific information. Lilly emphasized that the information has already been shared with the FDA, published in medical journals or used at various legal trials for more than a decade. (Related article: Lilly denies anything new in Prozac documents)

Lilly has reviewed the documents, which are a collection of various single pages and groupings in no particular order, and created an extensive annotation. Due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to release the 52 pages of documents.

"While it is important that we correct false assertions about how Lilly manages its data, it is even more important to set the record straight for patients who rely on our medicines for their daily well-being," said Sidney Taurel, chairman, president and chief executive officer. "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," said Taurel.

In Lilly's open letter to the public, Taurel states: "At Lilly, we're concerned that the BMJ story, and misleading reports about it in other media, have needlessly spread fear among patients who take Prozac. But the best thing that we can do is to seize this as an opportunity to improve everyone's access to information about Prozac - one of the most widely studied therapies in the entire history of medicine."

The article published by the BMJ and subsequent articles from various media contain false allegations regarding disclosure about important Prozac safety information as well as misleading and scientifically invalid conclusions about Prozac data.

"Lilly has always been forthcoming with safety data. This particular information has been shared with regulators and publicly discussed by experts, with conclusions supporting Prozac's safety," said Alan Breier, M.D., vice president and chief medical officer, Eli Lilly and Company. "We are confident that there is more known about Prozac after two decades of rigorous study than any other comparable medication," he added.

Erroneous conclusions drawn from tables comprised of spontaneous adverse event data (a reporting system for a particular drug comprised of adverse events occurring in people taking the drug) in the documents obtained by BMJ are at the heart of the data misrepresentations and reflect the fundamental problem of the BMJ reporting on statistical information without providing scientific context. Specifically, the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants is patently false and not supported by clinical trial data.

"A worrisome outcome from these inaccurate reports would be for patients who are stable on medication to stop treatment unnecessarily, which has the potential of undoing clinical progress and setting back patients in their illness," said Doctor Breier.

Among the documents provided to BMJ are charts created by a hired expert for plaintiffs' attorneys, whose own admission in legal testimony concluded that the data contained in these charts do not show that Prozac causes suicidality or violence. These very data were initially presented by the FDA to evaluate the safety of Prozac in 1991 to an advisory committee comprised of external experts. The FDA advisory committee voted unanimously in support of Prozac's safety.

Spontaneous adverse event reports have been the subject of significant research in the scientific community, and it is widely agreed that only controlled clinical trials can achieve valid comparisons between medications. Drawing conclusions about causality from spontaneous adverse event reports is invalid, given several important limitations. The limitations include the nature of voluntary reporting, variables such as other drugs a patient may be taking and duplicate reporting of the same adverse event from more than one source (e.g., pharmaceutical company, patient, physician, and pharmacist). Reports on suicide attempts and suicidal ideation, in particular, are problematic because each case represents an individual with varying degrees of illness, treatment and support, making it difficult to understand the nature of the event.
Prozac has helped to significantly improve millions of lives and it has been prescribed for more than 54 million people worldwide.

To demonstrate Lilly's transparency, the company is in the process of talking to all parties - the FDA, Congressman Hinchey, and the BMJ, in an effort to resolve the situation. Lilly is committed at the highest level to ensuring that all parties, and most importantly, our customers, are satisfied with those answers. Additionally, Lilly is calling on the BMJ to make the full documents available to media and other interested parties. Lilly obtained the documents from the office of Congressman Maurice Hinchey (D-NY).

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Source: Eli Lilly