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Feb. 19, 1997: Patricia Williamson, 60, of Beaumont, Texas, stabs and slashes herself more than 100 times with a stitch remover in the bathtub while her husband eats breakfast in their kitchen. On the advice of a psychiatrist, she had begun taking Prozac six days earlier to help her through a depression that had arisen just a few months before. Her husband, hearing strange noises in the bathroom, pried open the door and found his wife of 20 years semi-conscious in a pool of her own blood. She died the next day in the hospital. Lawyers for Eli Lilly, the pharmaceutical giant that makes Prozac, recently reached an out-of-court settlement in the case.
March 1996: Daryl Dempsay, 35, stabs his wife and two children at their home in Burlington, Kan., then shoots and kills himself with a .22-caliber rifle. His wife and children survive, and have charged in a recently filed suit against Pfizer that Dempsay’s violent outburst was caused by an adverse reaction to Zoloft, which he had been taking for several weeks.
What would cause these people to become so violent or suicidal? The surviving family members and their lawyers — along with some experts and anti-psychiatry activists — contend that this volatile behavior is an extreme manifestation of a rare side effect of the new antidepressants.
The side effect, called akathisia, creates a feeling of distress, agitation and restlessness that leaves people jittery and unable to sit still or to stop shaking their legs. “In its milder form,” wrote Pfizer scientist Roger Lane in a journal article published last year, “it is experienced as a vague feeling of apprehension, irritability, dysphoria, impatience or general unease.”
“Akathisia is like being tortured from within,” says Peter Breggin, a Maryland psychiatrist and prominent critic of Prozac and other psychiatric medications. “It’s like the screeching of chalk down a board, only it’s going down your spinal column.
“This agitation or akathisia drives a person into extreme states of irritability, anger, and frustration,” Breggin continues. “People can become more depressed and more despairing; their impulse control loosens and they do stupid things. So the violent impulses that an ordinary person would control come pouring out or even appear for the first time.”
In his article, Pfizer’s researcher Lane described the suicide risk of SSRIs — selective serotonin reuptake inhibitors, the class of drug to which Prozac and Zoloft belong — in this way: “It may be less of a question of patients experiencing … suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.”
Lane’s article focused specifically on akathisia and other similar side effects caused by SSRIs. Yet the word “akathisia” never appears in the package insert for Zoloft that is supposed to inform doctors about the risks and side effects of medication. And while akathisia is mentioned as a rare side-effect in the Prozac insert, both companies continue to publicly underplay the risks.
“This is an old story, it’s gone around and around,” says Jeff Newton, a spokesman for Eli Lilly. “But there’s ample evidence that Prozac is in no way linked to these kinds of violent behavior.” In fact, he added, Prozac reduces aggressive behavior and may lower the risk of suicide.
Pfizer representative Celeste Torello rejected the notion that Zoloft had any role in causing suicides or violence. “There’s no scientific or medical evidence that Zoloft causes violent or suicidal behavior,” she told Salon Health. “At this point, there have been over 90 million prescriptions written and there hasn’t been any evidence that it causes anything close to what Brynn Hartman did.” (When asked why Roger Lane, her own company’s scientist, discussed akathisia in his journal article but the company included no similar information in their package inserts, she declined to comment due to the pending lawsuit.)
To Andy Vickery, the lead attorney in the Hartman case and the other cases mentioned above, the failure of Pfizer and Eli Lilly to adequately warn doctors and patients about the possible risks constitutes gross negligence. “They withhold critical information from prescribing physicians, the public and the patients,” he says — information that would help doctors and patients recognize the symptoms of akathisia in time to do something about them.
Eli Lilly’s contention that Prozac is safe is bolstered by two jury verdicts in the company’s favor — one several years ago in a Louisville, Ky., case and the other earlier this year in Hawaii. In the Hawaii case, a jury cleared the drug maker in the death of a Hawaii man who killed himself and his wife 10 days after he began taking Prozac. (However, a motion for a new trial was heard on July 1, due to complaints by two jurors that they did not actually concur with the supposedly unanimous verdict. A ruling is expected shortly.)
“Litigation [against Lilly] has never worked,” Newton claims, though he acknowledges that Lilly has settled some lawsuits out of court. Newton claims the number is “very small” and they were made strictly as a business decision to avoid tying up company scientists and lawyers. Vickery says he settled nine Lilly cases last year alone, and has several more pending or waiting to be filed.
The idea that SSRIs can trigger suicidal or homicidal behavior is far from new. Indeed, the issue first exploded into public consciousness 10 years ago, when a former employee of a Louisville printing plant, Joseph Wesbecker, strolled into the plant with an AK-47 and started shooting. He killed eight people, wounded 12 and then turned the gun on himself.
Wesbecker had been taking Prozac for about a month, a fact seized upon by attorneys for the shooting victims and trumpeted on TV talk shows. Wesbecker’s sons did Larry King Live; one of the surviving victims went on the Donahue show for a program called “Prozac: the medication that makes you kill.” They claimed that Wesbecker had never been violent prior to taking Prozac.
But that claim was disputed by accounts in the local newspapers, which portrayed Wesbecker as a man with a deeply troubled past who had been hospitalized for mental disorders on three occasions, had made numerous suicide attempts and had reportedly told his wife a year before his rampage that he’d like to go to the plant “and shoot a bunch of people.”
About the time of the Louisville shooting, Harvard psychiatrists were finishing up an article for the American Journal of Psychiatry about six patients who “developed intense violent suicidal preoccupation” after taking Prozac for two to seven weeks. While three of the patients had attempted suicide in the past as a result of their depression, none were suicidal at the time they started on Prozac, the authors reported, and none had experienced suicidal urges on other psychiatric drugs. For all of them, their fixation with dying abated after they stopped taking the drug.
The article, coauthored by a leading expert on psychiatric drugs, sparked great interest and controversy within the psychiatric and pharmaceutical world. Other clinicians soon weighed in. A series of journal articles reported on cases in which patients on Prozac developed akathisia. When they stopped taking the medications, the researchers reported, the violent or suicidal urges abated.
Eli Lilly itself disputed the validity of case reports involving individual patients, criticizing them as inferior to the randomized clinical trials the firm had sponsored involving thousands of patients. Those studies, the company claimed, showed no evidence of suicidal impulses emerging among patients taking Prozac. Other researchers agreed with Eli Lilly, and submitted their own studies that found no increased suicide risk from Prozac.
In 1991, the FDA joined the fray, assembling a panel of experts to study the issue of Prozac and suicide and report back. The panel’s conclusion: There was no credible evidence linking the drug to acts of suicide or violence. Though critics complained that the panel had been stacked with paid consultants to Eli Lilly, its opinion — coupled with Eli Lilly’s success in dismissing or settling out of court scores of lawsuits — seemed to settle the issue and remove it from the public spotlight. Until now.