The Boston Globe
May 7, 2000
By Leah R. Garnett, Globe Staff

Just as the 14-year patent on Prozac is about to expire and the drug's maker, Eli Lilly and Co., is preparing to launch a new version, a body of evidence has come to light revealing the antidepressant's dark side.

The company's internal documents, some dating to the mid-1980s, as well as government applications and patents, indicate that the pharmaceutical giant has known for years that its best-selling drug could cause suicidal reactions in a small but significant number of patients. The reports could become critical as Lilly seeks government approval for its new Prozac.

Among the findings:
- Internal documents show that in 1990, Lilly scientists were pressured by corporate executives to alter records on physician experiences with Prozac, changing mentions of suicide attempt to "overdose" and suicidal thoughts to "depression."

- Three years before Prozac received approval by the US Food and Drug Administration in late 1987, the German BGA, that country's FDA equivalent, had such serious reservations about Prozac's safety that it refused to approve the antidepressant based on Lilly's studies showing that previously nonsuicidal patients who took the drug had a fivefold higher rate of suicides and suicide attempts than those on older antidepressants, and a threefold higher rate than those taking placebos.

- Lilly's own figures, in reports made available to the Globe, indicate that 1 in 100 previously nonsuicidal patients who took the drug in early clinical trials developed a severe form of anxiety and agitation called akathisia, causing them to attempt or commit suicide during the studies.

- Though Lilly has steadfastly defended the drug's safety and downplayed studies linking Prozac to suicide, the patent for the new Prozac, R-fluoxetine, expected to be marketed by Lilly beginning in 2002, notes that the new version will not produce several existing side effects including "akathisia, suicidal thoughts, and self- mutilation," which the patent calls "one of its more significant side effects."

- A McLean Hospital researcher and associate professor at Harvard Medical School, Dr. Martin Teicher, whose early 1990s studies linked Prozac to akathisia and suicide, is a co-inventor of the new Prozac, which Lilly plans to market, along with Timothy J. Barberich, the CEO of Sepracor Inc., a Marlborough drug company, and James W. Young.

- A just-published book, "Prozac Backlash," by a Cambridge psychiatrist, Dr. Joseph Glenmullen, has drawn Lilly's ire for discussing Prozac's link to suicide, tics, withdrawal symptoms, and other side effects of Prozac and similar antidepressants.

Lilly officials continue to defend the drug's effectiveness, saying its track record is borne out by the fact it is still the most widely prescribed drug of its kind. In a written statement, Jeff Newton, a Lilly spokesman, said: "There is no credible evidence that establishes a causal link between Prozac and violent or suicidal behavior. There is, to the contrary, scientific evidence showing that Prozac and medicines like it actually protect against such behaviors."

Using figures on Prozac both from Lilly and independent research, however, Dr. David Healy, an expert on the brain's serotonin system and director of the North Wales Department of Psychological Medicine at the University of Wales, estimated that "probably 50,000 people have committed suicide on Prozac since its launch, over and above the number who would have done so if left untreated."

Healy, meanwhile, is conducting a new study that he says is the first of its kind, giving antidepressants to healthy people to study possible links to suicide. The results are expected to be published in June.

Prozac's success is certainly unquestioned. The introduction of the drug to the US market in the late 1980s changed the way Americans viewed their most intimate emotions and limitations. Billed as a wonder drug to combat depression by boosting levels of the brain chemical serotonin, Prozac and others like it were also said to remedy a host of human frailties from poor self-esteem and concentration to fear of rejection.

By the end of last year, more than 35 million people worldwide were using the drug, which provided Lilly with more than 25 percent of its $10 billion in 1999 revenue.

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