Contributed by William Angelos| 02 January, 2005 01:19 GMT
Clinical trials show Prozac can cause behavioral disturbances, one of the documents reports. The FDA recently issued a warning that antidepressants can cause stimulatory side effects, including agitation, panic attacks and aggressiveness.
Suspicions over potentially lethal behavioral side effects of the antidepressant drug Prozac (fluoxetine) have been inflamed by a dramatic chain of invents: The BMJ (British Medical Journal) says it received confidential documents linking Prozac to suicidal and violent behavior from an anonymous source, and that it has turned them over to the U.S. Food and Drug Administration (FDA) for review.The papers, which reportedly went missing in a 10-year old murder trial, are said to implicate Prozac maker
Eli Lilly as having known about the possible dangerous side effects since the 1980s. The company reportedly sought to minimize the negative impact on drug prescriptions that the revelation of such information likely would have caused.
Lilly Made Secret Settlement
The documents reportedly disappeared during the case of Joseph Wesbecker in 1994, who killed eight people at his workplace in 1989, while taking fluoxetine. He then shot and killed himself.
In 1994, some of the relatives of the victims brought a civil suit against Eli Lilly, alleging that the company had known about the side effects of fluoxetine for years (including the fact that it might increase violence). The company won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid.
One of the documents, dated November 1988, reports that in clinical trials fluoxetine can cause behavioral disturbances. The FDA recently issued a warning that antidepressants can cause stimulatory side effects, such as agitation, panic attacks, insomnia and aggressiveness.
Documents Provide 'Missing Link'
These documents provide "the missing link" between the recent FDA advice and what Lilly scientists knew 16 years ago, says Harvard psychiatrist Dr. Joseph Glenmullen.
The FDA clinical reviewer who approved fluoxetine, Dr. Richard Kalpit, said he was not given the Lilly data. "These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it," Dr. Kalpit said.
"This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs," said Congressman Maurice Hinchey, "so that patients and their doctors -- not the drug companies -- decide whether the benefits of taking a certain medicine outweigh the risks." Hinchey (D-New York) currently is reviewing the documents to determine whether Lilly withheld data from the public and the FDA.
Lilly Responds
Lilly is defending Prozac, saying that it "has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine and has been prescribed for more than 50 million people worldwide. The safety and efficiency of Prozac is well studied, well documented, and well established."
The company says that to its knowledge, there has never been any allegation of missing documents from the Wesbecker trial and that it has always been its objective to publicly disclose data about both the safety and efficacy of fluoxetine.
Lilly says it has made several requests to the BMJ to obtain copies of the documents but has not received them.
Lilly notes in a statement that "contrary to what is stated in the BMJ article, it is well established scientifically that fluoxetine does not act in the same manner as cocaine."
Click here to view the BMJ's full paper. |
Home 
Public Health & Safety 
