Healthy Skepticism Library item: 748
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Abboud , L .
Eli Lilly Goes On the Offensive To Defend Prozac
THE WALL STREET JOURNAL 2005 Jan 13
Full text:
Eli Lilly & Co. gave regulators detailed documents to rebut allegations made by a prominent British medical journal that it concealed data linking its antidepressant Prozac to increased risk of suicide.
Lilly produced and submitted to the Food and Drug Administration 16 pages of annotations and explanations for documents that the British Medical Journal used to make its allegations. In the annotations, the company charted out a chronology of its multiple submissions and communications with health regulators to make the case that it had been forthcoming about Prozac side effects. Lilly identified what the documents were, when they were written and by whom, and what was done with them, information that had been missing.
The BMJ said it couldn’t comment because it hadn’t seen Lilly’s response to the documents.
The flap began when the BMJ published an article Jan. 1 saying it had given the FDA copies of confidential Eli Lilly internal documents that showed the company long had known about troubling side effects and played down the risks. The BMJ also quoted an FDA reviewer who worked on the Prozac application as saying he wasn’t given the data.
The BMJ said it obtained the documents, which emerged from a product liability lawsuit in the 1980s, from an anonymous source. They later were made public by Rep. Maurice Hinchey (D., N.Y.), who is investigating the allegations.
Lilly said it hit back because the BMJ article was inaccurate and widely covered in the media. The company plans to publish an “open letter” to doctors and patients in national newspaper advertisements today to dispute the reports. “The BMJ published an inaccurate and misleading report on Prozac,” said Greg Brophy, Lilly’s director of U.S. regulatory affairs. “Lilly wants to set the record straight.”
The public battle between Lilly and the BMJ comes at a time when issues of drug safety and clinical trial disclosure are in the spotlight. The FDA has been criticized for being too lax in its oversight, and a top-selling arthritis drug was removed from the market because of links to cardiac problems. The FDA, after an intense public debate, also recently issued a warning that antidepressants sometimes can cause an increased risk of suicidal thinking and behavior in children with depression and other psychiatric disorders.
Lilly specifically disagreed with the BMJ’s central allegation that Lilly hid a 1988 internal memo that reported that Prozac caused 38% of patients in clinical trials to experience “activation,” a clinical term used to describe nervousness, agitation or insomnia, compared with 19% in the placebo group. Because “activation” can be a marker of increased risk of suicide, such data are central to whether the drug causes violent tendencies.
Lilly said the charge that it had concealed the information was wrong because it had published five articles in peer-reviewed medical journals on the issue of activation and Prozac, some of which showed up to 40% rates of activation.
“It’s absurd to say that we weren’t forthcoming on data on activation and agitation,” said Alan Breier, Lilly’s chief medical officer. “Every bit of data we’ve had on agitation that has any relevance whatsoever has been published.”
Lilly also singled out five pages of charts included in the documents used by the BMJ that were widely reported in the media as showing that Prozac caused suicidal thoughts and behaviors far more often than the older antidepressants in use at the time. Lilly said the slides actually were prepared by an FDA official and presented at a 1991 advisory-panel meeting held to evaluate Prozac’s possible link to increased risk of suicide. A FDA spokeswoman confirmed that the slides were made by someone at the FDA.
