But the marketing dream soon turned into a PR nightmare as patients began to complain of unpleasant side-effects such as nausea, sexual dysfunction, insomnia and gastrointestinal bleeding. Worse, Prozac some-times caused violent, irrational behaviour. In one infamous case, a middle-aged factory worker became homicidal while taking Prozac, killing five people and wounding 12 others at his workplace.
In another example of horrific behaviour as a result of taking this drug, a female patient attacked her mother by biting her so viciously that she managed to rip away 20 chunks of her mother’s flesh. Eli Lilly was ordered to pay substantial damages.
After SmithKline Beecham (now GlaxoSmithKline or GSK) weighed in with their own SSRI, Seroxat (paroxetine), similar side-effects were seen with their drug, too. Even doctors began to express some concerns. “Physicians are seeing long-term side-effects from SSRIs far in excess of what was expected from the clinical trial data,” Dr Norman Sussman, a psychiatrist at New York University Medical Hospital, told the press in 1998 (Clin Psychiatr News, 1998; 26: 1).
Within a few years, Seroxat was following Prozac into the courts. In June 2001, GSK was ordered to pay $6.4m to the family of Donald Schell, who, after just two days on Seroxat, killed his wife, daughter, grand-daughter, and finally himself. Although GSK tried to claim that the drug wasn’t to blame, the British expert witness Dr David Healy, of Bangor University in North Wales, told the court he had uncovered early Smith-Kline Beecham documents which acknowledged that serious symptoms of agitation could occur after taking the drug for just a few days.
Dr Healy, now a professor of psychiatry at the North Wales Department of Psychological Medicine, has recently been in the news again, after publishing an article in the scientific literature accusing drug companies and their official regulators of dirty tricks (BMJ, 2006; 333: 92–5).
The target of his concern was the fact that the drugs cause some people to commit suicide: indeed, these highly sophisticated drugs apparently can precipitate the fatal behaviour that psychiatrists spend their lives trying to prevent.
The first warnings of this effect were sounded as early as 1991, when researchers looked at the placebo-controlled clinical evidence for fluoxetine, and discovered a spike of suicides (BMJ, 1991; 303: 685–92).
Drug companies glossed over such findings, and even complained that placebo-controlled trials were unethical, as SSRIs were self-evidently both effective and safe. However, as Professor Healy revealed in his British Medical Journal article, he “obtained access” to some of the original drug-company data, which gave the lie to their official PR line. He was able to confirm that, in the evidence presented to the licensing authorities, “every antidepressant licensed since 1987 [showed] an excess of suicides”.
The companies, he said, had “obscured” the suicide evidence by fudging the data, a practice euphemistically referred to as ‘recoding’.
When Healy challenged Pfizer (which makes sertraline, marketed as Zoloft) and GSK with his bombshell discovery, they didn’t deny that recoding had occurred, but noted that “the FDA [Food and Drug Administration, the US’ ‘watchdog’ regulatory body] has neither criticised these data or the report as inappropriate, nor required additional analyses”.