A STRONGLY CRITICAL PERSPECTIVE ON PROZAC, AND THE FDA’S APPROVAL OF ITS USE
Psychiatrist Peter Roger Breggin wrote in the introductory section of this 1994 book, “Most books about psychiatric drugs provide the kind of information that drug advocates and pharmaceutical companies want the public to have… This book is different. It provides information not readily available, even to most experts in the field. Much of it, in fact, has been systematically withheld from physicians and patients alike… Like many mental health professionals… Many biologically oriented psychiatrists argue that medication is the best or only approach to the problems they diagnose and treat… some psychologists support the pharmacological approach that we criticize, while many others do not… In seeking help from mental health professionals… it is best to inquire in advance about their views.”
He explains, “Prozac is now the most frequently prescribed psychiatric drug… competitors have begun to vie for a share in the market in this new class of drugs called SSRIs (selective serotonin reuptake inhibitors)… Once a drug is approved for marketing by the FDA, there are no government controls over what the physicians can prescribe it for. While Prozac was originally approved for depression… it and other SSRIs quickly began to be prescribed for a wide variety of ailments and difficulties, such as seasonal affective disorder (SAD), obesity… panic disorder… [and] behavioral and emotional problems in children and adolescents.” (Pg. 4)
He continues, “With the publication of Peter Kramer’s book [‘Listening to Prozac’], Prozac entered a new phase. It became a drug for enhancing the lives of people who otherwise consider themselves normal… The winter of 1993-1994 saw a new explosion of promotion and controversy surrounding Prozac… A series of extraordinarily laudatory TV news stories followed… At first, serious criticism and critics were absent from the pro-drug media hype for Prozac. But the daytime talk shows soon began to discover the existence of the darker undercurrent that had been missed… including large numbers of people who said that they … had ben emotionally damaged and even ruined or killed by the drug. By this time I had gained visibility as an outspoken critic of Prozac and other psychiatric drugs, and I found myself being invited onto so many talk shows, including Oprah, that I couldn’t schedule appearances on all of them.” (Pg. 4-5)
He observes, “The Prozac craze at first suggests a radical change in America’s thinking… It used to be that we suspected and even vilified drugs that ‘just made you feel good.’ The government outlawed them… does this enthusiasm for Prozac suggest problems with the drug that we haven’t yet faced? Gradually, the media and the public are becoming aware of the potentially dangerous implications in … this new drug. As a result of the avalanche of adverse publicity, including… reports of violence and suicide, the FDA felt compelled to hold hearings on Prozac in 1991.” (Pg. 7)
He reports, “While many patients and professionals seem to be listening to … its manufacturer, Eli Lilly, and to the medical-industrial complex that promotes medication—a hitherto underground movement of Prozac survivors is making an increasing public impact…. The members of the national Prozac Survivors Support Group include hundreds of former patients and their friends and families… [It] is wholly independent, receives no funding from anyone, and is not affiliated with crank groups or cults. It is run by volunteers.” (Pg. 11)
He suggests, “The moral and psychological dangers posed by Prozac are ultimately more threatening than its physical side effects… it has garnered a degree of media support never before encountered, as well as a best-selling book by Peter Kramer to fuel its popularity… Kramer argues that Prozac can transform personality for the better but largely dismisses the far more likely possibility that, like any psychoactive drug, it can transform it for the worse… In my conversations with Kramer and in his media appearances, he seems genuinely concerned that his book has helped to fuel the Prozac craze… On a talk show we appeared on together, he warned that there’s no way to anticipate Prozac’s potentially damaging effects on the developing brains of children and adolescents…” (Pg. 17-18)
He continues, “It’s time to address the real issues and questions about Prozac: *Did Prozac perform well or even adequately during the FDA trials, or was the FDA overeager to approve it?.. *Do people really function better on Prozac and, if so, what does that mean about their lives? *Can Prozac encourage or worsen someone’s tendency toward violence, depression, and suicide?... *… why did the [FDA] exonerate the drug at its 1991 hearing?... *Why is there an avalanche of lawsuits against Eli Lilly regarding Prozac? *What methods does Lilly use to push America to buy its pill?” (Pg. 18-19)
He points out, “Most people believe that when Prozac was approved for depression, it had been thoroughly tried on extremely depressed patients and had proven life-saving. In actuality, the Prozac studies as designed by Lilly excluded all patients with serious tendencies toward suicide. This deliberate exclusion was part of the formal protocol… of each study used for FDA approval… Advocates of the drug would wholly overlook this in their enthusiastic reviews, giving the false impression that Prozac is a potentially life-saving drug… No antidepressant has ever been shown to prevent suicide, and Eli Lilly apparently didn’t want to risk finding out whether Prozac would also fail to prevent suicide. Hospitalized psychiatric patients were also excluded from nearly all of the studies, including every one that was used to approve the drug.” (Pg. 44)
He explains, “According to the FDA approval process, it doesn’t matter how many times a drug FAILS to prove useful in its clinical tests. Innumerable scientific studies can show the drug to be ineffective, but as long as two or more show statistical superiority over placebo, the drug can win approval.” (Pg. 47)
He asserts, “the three protocols we have examined were the only ones that the FDA judged valid enough to use for demonstrating efficiency… These three badly flawed efforts, with many patients suffering adverse reactions, are the basis for the FDA allowing Prozac to be given to millions of Americans. A lot of fancy numbers-crunching was required to make Prozac look any better than a lowly sugar pill… These three protocols---with only 286 Prozac patients finishing the 4- to 6-week studies---were the best that Eli Lilly could come up with to prove the value of Prozac. We believe the FDA … should not have approved Prozac.” (Pg. 63-64)
He notes, “Lilly’s studies for FDA approval demonstrated that Prozac can cause psychosis, especially mania. Hypomania and mania are especially disastrous reactions because they can lead people to ruin their lives… The shortness of the trials greatly limits the percentage of patients who will become affected… There are numerous published reports and other confirmations that Prozac can produce a variety of other mental and behavioral abnormalities, from obsessions and compulsions to murder to suicide, but these have largely been rejected by both Eli Lilly and the FDA. Perhaps the most central and destructive effect of all… is a loss of empathy for oneself and others---a kind of withdrawal from human connectedness and caring.” (Pg. 103-104)
He summarizes, “Prozac can cause a range of psychological and neurological disorders that can lead to destructive actions. First, Prozac frequently causes agitation, panic, or anxiety. These emotional responses can make a person desperate enough to commit suicide or to perpetrate violence. Second, Prozac causes mania in a significant percentage of patients, and mania can lead to suicide and violence… Third, Prozac very commonly causes the neurological disorder ‘akathisia,’ which can drive people into violence toward themselves or others. These first three… are the most commonly associated syndromes with Prozac-induced violence and suicide, as well as other bizarre and destructive actions… Fourth, Prozac can cause depression… Fifth, Prozac can cause paranoia---an irrational fear and blaming of others---that can lead to violence… Sixth, Prozac can cause obsessive-compulsive thoughts and behavior, including preoccupations with death, murder, and suicide. Seventh, Prozac frequently causes insomnia…” (Pg. 176-177)
He concludes, “Biological psychiatry---with its genetic and biological theories, drugs, and electroshock---is itself a depressing philosophy. It is no wonder that so many patients go from one drug to another, only to end up hospitalized for yet more toxic doses of drugs and electroshock… depressed people need, above all else, the inspiration to start living once again, this time in new and better ways.” (Pg. 251)
This book will be ‘must reading’ for those who are critical of Prozac, and other such drugs.