By Heather Feather
Published October 24, 2001
The Sacramento, California, "Bee"

Recently we were reminded that pricey prescriptions for gramps and granny are not the gravest offense some drug companies are guilty of when Eli Lilly announced it was halting development of a new and improved version of Prozac, its top selling drug.

The patent for the new formulation -- which cost Lilly $90 million -- claimed it would reduce "the usual adverse effects" of the original Prozac, including "nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts, self mutilation, manic behavior." Yet almost from the time it was introduced in 1988, Lilly has been maniacally denying claims that Prozac produces violent or suicidal reactions. Could the recent startling reversal have anything to do with the fact that Prozac's extremely profitable patent -- which brought Lilly $2.6 billion last year -- was set to expire in 2004? What's more, just this August, a federal appeals court shortened Lilly's exclusive patent by three years, allowing generic versions of the mega-drug to hit the shelves next summer.

The damning admissions in the enhanced Prozac's patent will be the center of a federal lawsuit scheduled to go to trial in Hawaii next summer. This will be the latest round in a legal battle initiated by the children of a man who, while on Prozac, fatally stabbed his wife and then himself (in other words, "suicidal thoughts, self mutilation, and manic behavior"). During the first trial, Lilly's lawyers and witnesses repeatedly claimed that violent or suicidal acts are not a side effect of Prozac. In fact, the president of Lilly's neuroscience product group, Dr. Gary Tollefson, testified under oath: "There is absolutely no medically sound evidence of an association between ... Prozac and the induction of suicidal ideation or violence."

Clearly impressed with such expert testimony, the jury found the drug company not liable for the murder-suicide. The latest suit charges that "a fraud was committed on the court" when Lilly failed to disclose the potentially explosive data contained in the patent, which it had purchased three months before the first trial began. "It is incredible," said Karen Barth, one of the attorneys suing Lilly, "that on the one hand, Lilly vehemently argues to a federal judge and [*] jury that Prozac does not cause suicide and/or violence ... while on the other, pays $90 million for a patent ... which clearly acknowledges Prozac's propensity to increase the risk of suicide and violent behavior."

If there was no problem with Prozac, then why spend all that money to fix it? Lilly has faced over 200 Prozac lawsuits and has yet to lose a case -- opting to secretly settle the majority of them. The paitent disclosures could be the smoking gun that changes all that. "The new patent can be compared to the tobacco papers," argues Dr. Joseph Glenmullen, a Harvard Medical School professor and author of "Prozac Backlash." "It's a pharmaceutical company document that acknowledges this dangerous side effect, which has been downplayed by Eli Lilly and other pharmaceutical companies for a decade."

And the damning evidence against Lilly continues to mount. Last spring, an investigation by the "Boston Globe" found that, according to the drug company's own figures, "One in 100 previously nonsuicidal patients who took the drug in early clinical trials developed a severe form of anxiety ... causing them to attempt or commit suicide during the studies." And a recent study by brain chemistry expert Dr. David Healy of the University of Whales estimated that roughly "50,000 people have committed suicide on Prozac," people who wouldn't have had they not been on the drug. In the final debate, Gore criticized the pharmaceutical companies for "spending more on advertising and promotion" than on "research and development."

He's right about that: In 1999, each of the five biggest drug companies spent more than double on sales and marketing than on R&D. The most egregious aspect of the ads is the creation of an artificial demand for drugs with side effects far more severe than the ailments they claim to treat. The latest targets of Eli Lilly's admeisters are women suffering from "mood swings, irritability and bloating" brought on by their monthly periods. The company's solution: a new drug called Sarafem, which comes in pretty little pink-and-lavender pills. The company's come-on: a marketing campaign urging consumers to be "More like the Woman you are." The company's secret: Sarafem isn't really a new drug at all, only Prozac with a makeover. But even more disturbing than the thought of millions of already cranky PMS sufferers being pushed over the edge by this re-packaged Prozac is the trend it exemplifies: the turning of all of life's little unpleasantnesses into clinical conditions that require drugs purporting to get us back to our original perfect selves.

As Dr. Peter Kramer, author of "Listening to Prozac," puts it: "The implication is that the premenstrual self is inauthentic, that irritability is incompatible with the female gender. And that the truest state is the medicated one." Maybe Al Gore got it all wrong on health care. Instead of fighting to make prescription drugs cheaper for people, maybe the fight should be to price certain drugs out of their reach -- in an effort to save their lives.