How Lilly Gilded Prozac's Profile

Early Warnings

David Healy, a noted British psychiatrist and author of Let Them Eat Prozac, has taken aim at Prozac and its competitors alike.

"I happen to believe that Prozac and other SSRIs can lead to suicide," Healy said at a 2000 university conference that would go on to spark a huge controversy. "These drugs may have been responsible for one death for every day that Prozac has been on the market in North America. In all likelihood, many of you will not agree with me on this -- [but] you haven't seen the information that I have seen."

Eli Lilly was quick to defend its own drug.

"While reasonable physicians may differ in their opinions of the safety and effectiveness of a given medication -- or even a class of medications -- the fact is that Prozac has been approved for use by medical regulatory agencies in 120 countries worldwide," the company told TheStreet.com. "Additionally, Prozac has been credited by millions of patients and their families with improving their lives. These facts speak to the overall safety of the product."

But clinical trial data, normally unavailable to the general public, has come to light, exposing serious problems with the drugs. In one drug trial, documents obtained by CNN show, some 3.7% of Prozac users attempted to commit suicide. The same study shows that less than 1% of participants on non-SSRI depressants engaged in the same behavior.

Trials of Zoloft have raised questions about the effectiveness of SSRIs as well. In a 1991 letter prior to the drug's approval, the Food and Drug Administration noted that two separate studies had shown Zoloft to be no more effective than placebo. The agency admitted that the evidence supporting Zoloft was "not as consistent or robust as one might prefer it to be." But it went on to say that such facts were "insufficient to undermine" approval of the drug.

Still, Pfizer itself was apparently worried.

"Pfizer's depression program has in fact demonstrated a roughly 50% failure to demonstrate efficacy in clinical trials, a great number of which remain unpublished," Healy wrote in a letter last summer to the FDA. "So poor were the results from the early trials that they raised concerns that this drug might not get through the regulatory authorities."

Not only did Zoloft often prove ineffective, Healy said, but the drug -- like other SSRIs -- seemed to heighten suicide risks as well. On multiple occasions, he said, clinical investigators linked Zoloft to suicidal tendencies.

"The evidence that Zoloft works is, in many respects, less strong than the evidence it causes suicidal behaviors," Healy concluded.

Pfizer didn't answer questions about the drug for this story.

To be sure, Healy has taken plenty of heat for his views. Most notably, he lost out on a prestigious job at the University of Toronto shortly after his controversial presentation in 2000. The university, which operates a big mental health center funded in part by the maker of Prozac, abruptly withdrew its offer to Healy because it no longer felt his approach was "compatible with the goals for development of the academic and clinical resource" at the school. Even now, Healy told the FDA, at least one public relations firm working for an SSRI maker specifically lists him as a "problem to be managed."