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Life Extension Magazine

LE Magazine April 1997

What's Wrong With Prozac

By Saul Kent

We had to listen to Prozac-now we get to talk back. Dr. Peter R. Breggin and Ginger Ross Breggin expose the hidden truth about the approval of Prozac in their book Talking Back to Prozac. "Talking Back" exposes the hidden dangers of one of the most popular drugs of all time. The Breggins paint a picture of a drug that skated through an FDA which offered little resistance to the manufacturer's wishes. Peter R. Breggin is a psychiatrist-formerly a consultant with the National Institute of Mental Health-who is a long-time critic of drug-based psychiatry. Ginger Ross Breggin is a writer and Director of Research and Education at the Center for the Study of Psychiatry.

image One of the most startling accusations the Breggins level is that Prozac is a chemical cousin of amphetamine and cocaine-drugs which also inhibit serotonin reuptake. It is those properties, the Breggins believe, that make Prozac dangerous. And dangerous it is. Ordinary people have done things such as getting out of bed in the middle of the night and hanging themselves after taking it. There are numerous reports of "speed"-like behavior and aggression. People have reported having nightmares where people are coming at them with knives, or they are going to kill others or themselves. One woman, put on the drug for weight loss, ended up trying to shoot herself in front of her children. (Her husband got the gun away from her). According to the Breggins, this type of behavior is consistent with what people sometimes do on cocaine or "speed". Is Prozac legalized "speed"? The Breggins make a good case.

The Truth About FDA Approval Of Prozac

"Prozac madness" might be dismissed as an infrequent and unfortunate side effect of an otherwise beneficial drug if it were not for the fact that the drug has never been proven to do what it is supposed to do. A meticulous dissection of FDA documents reveals that there is no proof that Prozac works better than tricyclic antidepressants - or that it works at all.

According to the Breggins, the 11,000 patients that Eli Lilly claims took part in clinical trials shrink to about 300 when the 5,000+ who got placebo instead of drug are deducted, along with the drop-outs. Further deducting the studies the FDA threw out because of fraud, ineptitude, and mixing other drugs with Prozac, the actual number of patients who completed clinical trials is minuscule. One of the main studies the FDA used in approving Prozac is based on data from only 11 patients! And it was conducted by a doctor who has been accused of fraud in other trials.

The Breggins show that, of the 14 clinical trials, 11 were either seriously flawed in design or failed to show that Prozac worked, and that the remaining 3 trials (which the FDA relied upon) were all weak and unpersuasive. None of the studies lasted for more than 6 weeks, and patients frequently rated Prozac as no better than placebo. There are millions of people taking this drug, trusting that clinical trials proved its safety, its efficacy, and long-term benefit, yet there is apparently no such data.

"Talking Back" contains numerous examples of the fraud that went on during the approval of, and subsequent marketing of, Prozac. When pressed by Peter Breggin to explain why he would state in a book that Prozac caused a 70% improvement in depression (when in fact it didn't exist), psychiatrist Ronald R. Fieve explained that it was his own personal feeling that there was a 70% improvement. When queried how the 1/3rd of the group that dropped out of the study fitted into the 70% improvement, Fieve explained that the 70% figure didn't include those folks. Fieve was paid by Eli Lilly to conduct clinical trials, and subsequently wrote a consumer handbook on Prozac.

Another investigator, J.P. Feighner, submitted at least one study that drew this comment from an FDA Director of Scientific Investigation: the study he submitted "had several departures from Food an Drug Administration regulations or commonly accepted drug investigational practices." He was admonished to follow the inclusion and exclusion criteria of the studies. The Breggins point out that none of the patients who participated in the Prozac studies were suffering from severe depression. While, some of this type of thing might occur in a large study, what the Breggins show is that juggling the data, and "cookin' the books" was the norm for the Prozac studies.

What is particularly unnerving is that data continues to be hidden from public view. The FDA's spontaneous reporting system is supposed to keep track of adverse events caused by approved drugs. That way, the FDA can monitor the drug for potential adverse effects that didn't show up in clinical trials. According to the Breggins, this is not being adequately done with Prozac. Certain adverse reactions, such as suicidal ideation, don't "fit" in the reporting system's computer, so they are simply left out. It's impossible to know what the incidence of side effects for Prozac truly are. One can only conclude that the real clinical trials for Prozac are being done on the American public-without its knowledge.

One of the most chilling aspects of the book is the possibility that Prozac may cause a type of social withdrawal and emotional flatness reminiscent of the worst sex offenders/murderers. Whether this type of personality change is common, or the Breggins have simply taken a few cases and exaggerated is notclear, but one thing is certain: Talking Back to Prozac is a must-read for anyone contemplating, or presently undergoing, Prozac therapy.