The Lilly Suicides

The Witness

In the final days of the 20th century, a North Wales psychiatrist named David Healy conducted a curious study, and with more than a curious result. Twenty volunteers with no history of psychiatric problems were recruited, half of whom were given the drug Zoloft, an antidepressant from the Prozac family of drugs known as the SSRIs, or "selective serotonin reuptake inhibitors." The other half were given an antidepressant that, unlike Zoloft and Prozac, does not selectively target the brain chemical serotonin. Each group took their respective drug for two weeks and then, shortly thereafter, switched to the other.

Healy had designed his "healthy volunteer study" to compare the psychological experience of being on a serotonin antidepressant versus a non-serotonin antidepressant, but before he knew it, two of his volunteers became dangerously agitated and suicidal. Both were taking the SSRI drug. The adverse reactions couldn't easily be blamed on psychological instability -- these were healthy volunteers. And the rate of 10 percent made it clear that such results were not so rare as to be incidental.

Healy was surprised at the effect, but he would not stay surprised. Some months later, when serving as an expert witness in a civil action against Zoloft's manufacturer, Pfizer, Healy obtained access to the company archives. There he discovered an unpublished study from the 1980s in which healthy female volunteers were given either Zoloft or a placebo. The study was canceled four days later, after all those taking Zoloft began complaining of agitation and apprehension. Healy's case was not so bad; in fact, some of his volunteers rated Zoloft positively. Of the two who did not, one was a 30-year-old woman who, within two weeks of starting the drug, became obsessed with the idea that she should throw herself in front of a car. "It was as if there was nothing out there apart from the car which she was going to throw herself under," Healy reported. "She didn't think of her partner or child."

The Zoloft case was not Healy's first involvement in a civil action against an SSRI manufacturer. Earlier, he had been involved in a wrongful death suit against Eli Lilly, the maker of the much celebrated SSRI drug Prozac. An internationally renowned psychiatrist as well as a historian of psychiatric medicine, Healy's recruitment onto the plaintiffs' side was a small but significant victory. Prior to his involvement as an expert witness, Healy had already raised a number of questions about the SSRIs, including the possibility that they might produce agitation and other problems with an unusual frequency, sometimes leading to suicide. Healy was also ideal because he's not a radical or an outsider; he has done research and consulting for various drug companies, and has himself prescribed SSRIs and other psychiatric drugs. In fact, he had been consulted on several SSRI suicide cases in which he had concluded that the SSRIs were not at fault.

This view changed, however, with the case of William Forsyth.

The Victims

William Forsyth met and married his wife June in 1955. After two years of military service in West Germany, Bill and June moved to Los Angeles, where Bill had grown up. After arriving, Bill started a rental car business, and the couple had two kids, Susan and Bill Jr. The business and other investments continued to grow, and in 1986 the Forsyths cashed in. Four years later, Bill and June retired to Maui, the Hawaiian island that their son called home. Bill was 61 at the time. June was 54.

Despite the romance of a new life, the transition was difficult for Bill Forsyth. Personal difficulties led to marital difficulties. Marriage counseling seemed to help, though, and by the next year there was a general sense that Bill was on the mend. Three years after the move to Hawaii, however, with Bill still feeling unsettled, a local psychiatrist prescribed Prozac. The psychiatrist, who had been seeing Bill since the previous year, did not believe Bill to be either seriously depressed or suicidal.

After his first day on the drug, Bill was feeling as you might expect if you've read Peter Kramer's "Listening to Prozac" -- he was "better than well." The next day, however, he felt horrible, and for the first time put himself under hospital care. Ten days later, Bill felt well enough to leave the hospital, but was still taking Prozac. Everyone seemed to agree that he was doing better, and the family scheduled a boat trip for the next day. When his parents failed to show up that afternoon, Bill Jr. went to their home, where he found both his parents lying dead in a pool of blood. Eleven days after starting on Prozac, Bill Forsyth had taken a serrated knife from the kitchen and stabbed his wife 15 times. He had then taken the knife, fixed it to a chair, and impaled himself on it.

Depressed people sometimes do desperate things. Yet these were senseless acts that were simply unimaginable to those who knew Bill Forsyth. For his two grown children, the only possible explanation was the drug. They decided to sue.

The Forsyth case was not the first wrongful death suit to be brought against Eli Lilly. By the fall of 1994, a year after the Forsyth murder-suicide, there were already 160 cases filed against Lilly, linking Prozac to homicides, suicides, and other violence. Many of these cases were dismissed; others ended with cash settlements. But Lilly had not lost a Prozac case, and was determined to keep it that way. By the mid-1990s, Prozac sales were worth $2 billion per year, or about a third of all Lilly's income.

In March 1999, with Susan and Bill Jr. refusing to settle, the Forsyth case finally made it to trial in United States District Court in Honolulu. "I know that with all their power and money I don't have much of a chance," said Susan at the time, "but I feel like I have to try." With David Healy serving as an expert witness, the Forsyths' lawyers went on to argue that the Prozac family of drugs can produce a kind of psychological hijacking -- a bizarre and nightmarish syndrome marked by suicidal thoughts, extreme agitation, emotional blunting, and a craving for death. They also argued that the company knew of these risks and, instead of warning doctors to look out for them, worked vigilantly to sweep them under the rug.

The Evidence

Though Prozac is one of the world's best-known commodities, its most terrifying potential side effect, "akathisia," remains virtually unknown. Akathisia has been described as a unique form of inner torture that, prior to the development of psychiatric drugs, probably never existed. Knowledge of the side effect, however, has been around for a while. In 1978, 10 years before "fluoxetine" would be brought to the U.S. market and become the bestseller known as Prozac, initial clinical trails had already warned of akathisia and other problems. Minutes from Lilly's Prozac project team in that year noted, "Some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off [the] drug ... There have been a fairly large number of reports of adverse reactions."

As the Forsyth case and others would go on to show, Lilly's internal records revealed considerable awareness within the company. A letter sent to it from the British Committee on Safety of Medicines in 1984 reads: "During the treatment with [Prozac] 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation." Similar concern was expressed by German authorities in 1985, where Prozac is sold as "Fluctin," and with required warnings of possible akathisia and suicide. A Lilly document dated from March of that year even quantifies the problem, suggesting a rate of suicide for Prozac 5.6 times higher than for the antidepressants that were popular before the rise of the SSRIs -- the tricyclics. "The benefits vs. risks considerations for fluoxetine [Prozac] currently does not fall clearly in favor of the benefits," the document concludes. By 1986, clinical-trial studies comparing Prozac with other antidepressants showed a rate of 12.5 suicides per 1,000 users compared to only 3.8 per 1,000 on older, non-SSRI antidepressants, and 2.5 per 1,000 on placebos.

After Prozac's entry into the market in 1988, reports quickly surfaced to confirm that the beast Lilly saw in the laboratory had now, without warning, been unleashed upon the public. In 1990, a report appeared in the American Journal of Psychiatry on the "Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment." Two Harvard psychiatrists and a registered nurse described cases in which patients developed serious preoccupations with suicide soon after being given Prozac. "We were especially surprised to witness the emergence of intense, obsessive, and violent suicidal thoughts in these patients," they commented. "It was also remarkable how violent these thoughts were. Two patients fantasized, for the first time, about killing themselves with a gun, and one patient actually placed a loaded gun to her head. One patient needed to be physically restrained to prevent self-mutilation."

Two years later, in July 1992, another article appeared, this time in the Archives of General Psychiatry. Again, the article had two senior researchers among its authors, one of whom was a leading expert on akathisia. The psychiatrists stressed in the report that, prior to going on Prozac, none of their patients had a history of significant suicidal behavior. "All described their distress [while on Prozac] as an intense and novel somatic-emotional state; all reported an urge to pace that paralleled the intensity of the distress; all experienced suicidal thoughts at the peak of their restless agitation; and all experienced a remission of their agitation, restlessness, pacing urge, and suicidality after the fluoxetine [Prozac] was discontinued."

The finding that these problems emerge soon after an SSRI drug is taken, and then disappear soon after the drug is withdrawn, provides compelling evidence that the problem is often the drug and not, as the makers of SSRIs have insisted, the depression. Anthony Rothschild and Carol Locke, also of Harvard Medical School, reported three such cases in the Journal of Clinical Psychiatry in 1991. All three individuals had previously attempted suicide while being treated with Prozac -- in fact, each had jumped from great heights and had managed to survive. In turn, all three had been put back on Prozac, only to complain of the same strange desire to kill themselves.

"I tried to kill myself because of these anxiety symptoms. It was not so much the depression," said one of the individuals, a 25-year-old woman. Another, a 47-year-old man, complained that "this is exactly what happened the last time I was on [Prozac], and I feel like jumping off a cliff again." Reflecting on these cases, the Harvard researchers stressed that patients need to know that such overwhelming symptoms are the side effects of medication, and are treatable. "Our patients had concluded their illness had taken such a dramatic turn for the worse that life was no longer worth living."

The Accused

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 U.S. Food and Drug Administration asking questions, Lilly was pressed to show that their drug was safe. The result was published on Sept. 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 5 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 its drug was safe, the FDA's Psychopharmacological Drugs Advisory Committee gave the drug a clean 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 Oct. 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.

The Reckoning

Michael Grinfeld summed up Lilly's legal situation well, and prophetically, writing in California Lawyer magazine in 1998: "Lilly may eventually face a court judgment in a Prozac case, but it has succeeded beyond all expectations in postponing that day." Indeed it has. On April 2, 1999, despite David Healy's testimony and the surfacing of the Lilly papers, the jury in the Forsyth trial found in favor of Eli Lilly. In the eyes of the jury, Prozac did not cause Bill Forsyth to kill his wife and then himself.

While Lilly has continued to survive all legal challenges to date, not all plaintiffs' cases involving the SSRIs have ended in defeat. In May 2001, Australian David Hawkins was freed from prison after a supreme court judge said it was "overwhelmingly probable" that Hawkins would not have killed his wife or attempted suicide had he not been using Zoloft. In another 2001 case, a Wyoming court found against GlaxoSmithKline, maker of the SSRI Paxil. The jury found that Paxil can cause some individuals to commit suicide and homicide, and had done exactly that in the case of 60-year-old Donald Schell. After complaining of anxiety, stress, and possible depression, Schell had been prescribed Paxil by his family doctor. Two days later, Schell shot to death his wife, his daughter, his infant granddaughter, and then himself. David Hawkins, too, had committed homicide after his first two days of SSRI treatment.

Stories like these litter the communities of North America and Europe, most of them concealed behind the confusion and secrecy that so often mark sudden family tragedies. By the spring of 1999, 2,000 suicides by Prozac users had been reported to the Food and Drug Administration, at least a quarter of which appeared to be linked to agitation and akathisia. According to the FDA's own estimate, only about 1 percent of serious side effects are ever reported on its "adverse event system." This means that, as David Healy has concluded, as many as 50,000 akathisia-related suicides had taken place by 1999. The total estimate for all SSRIs would of course be much larger.

In the face of such statistics, and with the loss of their exclusive patent on fluoxetine, Lilly announced in December 2001 that it planned to bring another antidepressant to market late in 2002. Not surprisingly, the new drug, duloxetine, does not selectively target serotonin. The SSRIs, once hailed as a revolution in the treatment of depression, are now in the process of being phased out. Oddly, this is making way for pharmaceuticals that act in essentially the same way as the drugs that the SSRIs originally replaced. Given this backward trend, one is left to wonder whether all the death and misery linked to the SSRIs might have been for naught. If so, a final conclusion seems unavoidable: that next to Big Tobacco and the marketing of cigarettes, the selling of the SSRIs is perhaps the deadliest marketing scandal of the 20th century.

Richard DeGrandpre is the author of "Ritalin Nation" (1999) and "Digitopia" (2001), and is currently writing a history of drugs in the 20th century. "The Lilly Suicides" first appeared in Adbusters (May/June, 2002). For the full report on "The Lilly Suicides," log on to Prozac Spotlight.

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