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British Medical Journal Retracts Part of Its Prozac Story

Says Eli Lilly documents were not missing for 10 years

THURSDAY, Jan. 27, 2005 (HealthDayNews) -- The British Medical Journal has apologized to Eli Lilly & Co. for claiming in a Jan. 1 report that Lilly documents outlining a heightened risk of suicide use among Prozac users were missing for a decade.

The Associated Press quotes the journal's statement: "The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologize to Eli Lilly for this statement, which we now retract, but which we published in good faith."

The original BMJ report said editors had given U.S. regulators internal company documents it had received from an anonymous source, indicating Lilly officials were aware in the 1980s that the antidepressant could have potentially troubling side effects, and that those documents vanished during a 1994 lawsuit against Lilly. But AP reported that, on Jan. 4, 2005, Eli Lilly officials maintained the company had given those records to the U.S. Food and Drug Administration (FDA) more than a decade ago, and the documents had not gone missing during the court case.

After further investigation, the journal said it had determined that Lilly had indeed disclosed the documents during the lawsuit, according to the AP. However, the journal added that whether the FDA had been given the documents is still being investigated.

In a statement, Lilly Chairman and CEO Sidney Taurel, said the retraction was an "important step in gaining closure on this unfortunate event. It is Lilly's policy to be honest in our dealings with the public, the media, regulatory bodies and our customers."

The journal said the documents had formed part of a 1994 lawsuit against Eli Lilly on behalf of victims of a workplace shooting in Louisville, Ky. Joseph Wesbecker, the gunman who killed eight people and himself in 1989, had been prescribed Prozac a month before the shootings. Lilly won the case, but later disclosed it had settled with the plaintiffs during the trial.

The editor of the BMJ stressed that the apology was limited to the issue of whether the documents were missing from the court case, according to the AP.

"Whether or not Eli Lilly made all of the information available to the FDA at the appropriate times is a question for the FDA to answer. That is why we sent the documents to the FDA, and we await their response," said acting editor Kamran Abbasi.

HealthDay News reported on Dec. 30, 2004, that confidential company documents obtained by the BMJ suggested that drug giant Lilly was aware that Prozac was linked to troubling side effects as far back as 1988, the same year the drug was introduced to the U.S. market.

The discovery, reported in the Jan. 1 2005 issue of the BMJ, adds to the growing body of bad news for pharmaceutical companies. The papers have been turned over to the U.S. Food and Drug Administration.

Amid the pile of internal reviews and memos, according to the journal, is a document dated November 1988 that reports Prozac (fluoxetine) had caused behavioral problems, including agitation and panic attacks, in clinical trials.

The issue of disclosure is a loaded one. The FDA announced in October 2004 that antidepressants such as Prozac would now have to carry a "black box" warning that health-care providers should be on the lookout for, among other things, increased agitation, panic attacks, and aggression among users of the drugs.

This latest report also fuels the ongoing debate over which clinical studies should come to the attention of federal regulators and which ones should never the see the light of day.

Morry Smulevitz, manager of global product communications at Eli Lilly, said his company was committed making certain the public understood both the benefits and risks of its products.

"Certainly Lilly is committed to public disclosure of all clinical trial data so health-care providers and patients can make informed treatment decisions," he said. "Prozac has been prescribed for over 50 million people worldwide. It is one of the most studied drugs in the history of medicine, and its safety and efficacy is well-studied and well-documented and well-established."

Smulevitz said he had requested the documents from Jeanne Lenzer, a Kingston, N.Y.-based medical investigative journalist who received them and then sent them on to the BMJ and the FDA. But, he said, the request was not met.

Dr. Richard Kapit, the FDA reviewer who originally approved fluoxetine in 1987, told the BMJ that he had never been given the Lilly data.

"If we have good evidence that we were misled and that data was withheld, then I would change my mind [about the safety of fluoxetine]," he said in a statement. "I do agree now that these stimulatory side effects, especially in regard to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug."

The internal company document that stood out to Lenzer, she said, was one that discussed the finding that 38 percent of people have a stimulation effect, such as panic attacks and agitation, and that 19 percent of those could be attributed to the drug.

According to Lenzer, the document stated "one in five [patients] could be expected to experience this activation. And, later in the document, they talk about how to do damage control, how to get the doctors not to worry about this. Maybe the information actually got out and got buried. It's like a little flicker of a flame. Obviously they didn't get this out to a wide circulation. They didn't get it out to the people who needed to know. They didn't get it to the FDA safety officer who reviewed it."

Dr. Peter Breggin, a medical expert in the Wesbecker case, has said the activation effects could be higher than 38 percent.

More information

The U.S. Food and Drug Administration has more on antidepressant use in children.

SOURCES: Jan. 27, 2005, Associated Press report; Jeanne Lenzer, freelance journalist, Kingston, N.Y.; Morry Smulevitz, manager of global product communications, Eli Lilly & Co., Indianapolis, Ind.; U.S. Food and Drug Administration; Jan. 1, 2005, British Medical Journal
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