by John M. Curtis
(310) 204-8700

Copyright March 21, 2004
All Rights Reserved.

hen Eli Lilly & Co. introduced Prozac in 1988, it was supposed to revolutionize the biochemical treatment of depression. By 1990, the Church of Scientology filed suit against the drug maker, petitioning the Food and Drug Administration to take Prozac off the market, claiming it caused suicidal and violent behavior. Mounting anecdotal reports, denied by the manufacturer, linked Prozac to violence and suicide, complex behaviors difficult to blame on any one cause. Prozac was the world's first Selective Serotonin Reuptake Inhibitor [SSRI], the first medical breakthrough in treating biochemical depression in 30 years. Boosting serotonin was supposed to correct the biochemical imbalance responsible for endogenous depression, a condition caused by faulty genetics and impaired biochemistry. Fourteen-years after the FDA dismissed Scientology's claims, the FDA is finally ready to post warning labels.

      In Feb. 2004, an FDA advisory committee finally examined the link between SSRIs and suicidal and violent behavior. Several high-profile incidents prompted the FDA to take a closer look, especially for adolescents where the suicide rate exceeds other age groups. In a more recent incident, high school basketball star Corey Baasdsgaard, without any history of erratic behavior, held his English class at gun point, after receiving Paxil and Effexor, both SSRIs. After spending 14 months in juvenile hall, Baasdsgaard's father concluded that antidepressants caused his son's erratic behavior—something vehemently rejected by drug makers. Harvard psychiatrist Dr. Joseph Glenmullen, an expert on SSRIs, believed antidepressants added to Baasdsgaard's actions. “What is very, very clear is that people do become hostile on the drugs,” said Dr. David Healy, director of North Wales Dept. of Psychological Medicine.

      Adverse reactions from prescription drugs typically involve changes in various organ systems as measured by standard blood tests. Yet no blood test—or, for that matter, any other exam—measures suicidal or violent behavior, giving drug makers the perfect alibi to deny claims. When diabetic patients taking Warner-Lambert's Rezulin developed liver failure, it took three long years before the FDA yanked it off the market. Intense lobbying from drug companies and bureaucratic red tape currently prevents the FDA from making sound decisions. Warning labels aren't always enough drive the risks home to physicians and patients. Fourteen years after Scientology warned the public and petitioned the FDA, SSRIs are routinely prescribed to adults, adolescents and children. After a slew of reports about violence and suicide, the FDA finally considers posting warning labels.

      Warning labels won't stop primary care physicians from pulling out the Merck Manual and playing psychiatrist. Today's emphasis biochemistry leaves many patients treated with popular drugs, like Prozac or Paxil, when problems could be easily addressed with counseling or behavior therapy. While it's tempting to whip out prescription pads, common problems, including depression and anxiety, respond well to non-medical treatments. Antidepressants can worsen otherwise manageable problems by unnecessarily tinkering with patients' biochemistry. Primary care doctors don't have the experience treating depression, often upping dosages when symptoms don't improve. Before Corey Baadsgaard went ballistic, his personal doctor upped his dose of Effexor—another SSRI—from 40 mg to 300 mg, nearly an 800% increase. Overdosing depressed patients carry certain risks.

      Despite mounting anecdotal reports, drug makers find clever ways to deny any connection between SSRI use and destructive behavior. Dr. Alastair Benbow, Europe's medical director for GlaxoSmithKline—the maker of Paxil—denied “any clear evidence that Paxil is linked with suicide, violence or aggression—and certainly not homicide.” “Suicide and violence are well-recognized outcomes of depression itself,” said Benbow, ignoring growing evidence and refusing to consider risks of SSRIs. Even if the evidence isn't “clear,” it doesn't mean it should be ignored. Yet research by GlaxoSmithKline found that Paxil increased hostility in children 6.3% to 9.2%, compared with only 1% in the placebo group—that's an average 500% to 800% increase in aggression directly attributable to the drug. Wyeth Pharmaceuticals already reported clinical trials with children where Effexor increased hostility and suicidal tendencies.

      Far from a fluke, popular SSRIs are indeed linked to suicide and violence. It's been 14 years since the Church of Scientology exposed the dangers of Prozac, the world's first SSRI. Eli Lilly's relentless campaign to discredit the Church of Scientology resulted in the FDA ignoring legitimate concerns prescribing SSRIs to adolescents, the group with the least inhibitions and most prone toward erratic behavior. Out-of-court settlements with powerful confidentiality agreements have kept drugs like Prozac and Paxil out of the headlines. “It's an example par excellence of the behind-the-scenes maneuvering that the companies have done repeatedly to obscure the side effects from public view,” said Harvard's Glenmullen, concerned that warning labels wouldn't be enough to prevent potentially lethal incidents. Before the FDA turns eye, they should take a serious second look at SSRIs.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

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