Reports that Prozac might be unsafe at any dose had Lilly running scared. As early as 1990, one executive stated in an internal memo that, if Prozac is taken off the market, the company could "go down the tubes." With the US Food and Drug Administration asking questions, Lilly was pressed to show that their drug was safe. The result was published on September 21, 1991.
Authored by Lilly employees, the report claimed to represent all existing data comparing Prozac with either older antidepressants or placebos. In fact, the data had been hand-picked to favor the drug and the company. The analysis dealt with 3,065 patients, less than 12 percent of the total data from Prozac studies at the time. Among those whose data were left out was the very population most likely to become suicidal – the five or so percent of patients who dropped out of the clinical trials because they experienced unpleasant side effects after taking Prozac.
The Lilly study was rejected by the New England Journal of Medicine. Publication in the British Medical Journal was not as high profile, but it would have to do. And it did. With the study in hand, and with repeated assurances from Lilly that their drug was safe, the FDA's Psychopharmacological Drugs Advisory Committee gave the drug a clear bill of health in September 1991, concluding that there was "no credible evidence of a causal link between the use of antidepressant drugs, including Prozac, and suicidality or violent behavior." Prozac was saved.
It was not until trials like the Forsyth case that Lilly's internal documents would surface, revealing the depth of the deception. This included statements from the Prozac working group in 1978, acknowledging problems with akathisia and drug-induced psychosis. Also among the documents was evidence that the company had drafted (but later abandoned) a package insert for Prozac stating that, "Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy." And there was a memo dated October 2, 1990, which referenced an upcoming Prozac symposium. "The question is what to do with the 'big' numbers on suicidality," the memo states. "If the report numbers are shown next to those for nausea, they seem small."
The Lilly papers also contain a series of memos referencing a study by two Taiwanese doctors entitled "Suicidal attempts and fluoxetine (Prozac) treatment." In a 1992 memo, a Lilly employee reports, "Mission accomplished. Professor Lu will not present or publish his fluoxetine [Prozac] vs. maprotiline suicidality data." In a similar case, Lilly lawyers obtained a cease-and-desist order against Robert Bourguignon, a Belgian doctor who was soliciting his colleagues' impressions regarding Prozac side effects. Bourguignon eventually prevailed, and his survey, "Dangers of Fluoxetine," appeared in the Lancet in 1997.
Lilly's response to "Prozac suicide" court cases
was equally forceful. In the first case to go to trial, known as the Wesbecker
case, Lilly appeared to score a victory, only to have the judge, John Potter, declare
later that the case had been won under pretense. What Potter had learned was
that Lilly had settled the case during the trial, paying a huge sum in exchange
for the plaintiffs' keeping the settlement a secret. This sleight of hand
occurred immediately after Potter had decided to allow the plaintiffs' lawyers
to present evidence of past criminal behavior on the part of Eli Lilly. After
discovering the secret settlement, Potter fought to change the verdict, and
eventually succeeded in the Kentucky Supreme Court. The case had not been won,
but settled. This was, however, too little, too late. Lilly had achieved its
objective – to avoid losing even a single Prozac lawsuit.