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Another View: Talking Back to Prozac

Presents the views of the author, co-author with Ginger Breggin of 'Talking Back to Prozac,' on whether Prozac really improves depression. His investigation of FDA documents on its approval of Prozac; Prozac as a stimulant-like drug; The contention that Prozac remains unproven.

The Declaration of Independence affirms our right to the pursuit ofhappiness, but the Founding Fathers did not anticipate that laboratory-de-signed drugs such as Prozac would become the preferred path for so many. Prozac has become the most widely prescribed psychiatric drug in America.

Does it really improve depression? Long a skeptic about claims for new psychiatric wonder drugs, I decided to undertake a comprehensive analysis of the drug and its effects. Making extensive use of the Freedom of Information Act to obtain FDA documents pertaining to the approval of Prozac, what I found was more dismaying than my initial skepticism suggested. The full results are published in a new book, Talking Back to Prozac (St. Martin's) I co-wrote with Ginger Breggin.

Contrary to widespread public belief, the FDA does not conduct any of the studies used for drug approval; they are financed, constructed, and supervised by drug companies using doctors they hire. While it may take a decade for a drug to get through the FDA bureaucracy, the actual controlled scientific studies last--as in the case of Prozac--just four to six weeks. Anecdotal material is collected on longer-term patients, but for Prozac, only 63 patients were followed for more than two years before the drug's approval.

For starters, seriously suicidal patients and hospitalized patients were excluded. Of the included patients, many were allowed to take sedatives and minor tranquilizers to overcome Prozac's stimulant-like side effects, vastly compromising data interpretation.

After weeding out the most badly flawed studies, the FDA found only four that were adequate enough to consider. One of these showed that Prozac was no better than placebo. Three others supposedly showed Prozac to be somewhat superior to the sugar pill, but not as good as older antidepressants. However, due to adverse drug effects and lack of drug effectiveness, the dropout rates in most of these studies was very high.

While the gross number of patients receiving Prozac in all the trials was more than 5,000, the actual number finishing the trials used for approval was very small. When I counted the actual number of patients who completed the four- to six-week trials used for the approval of Prozac, it turned out to be a grand total of 286. It bears restating--only 286 patients finished the four- to six-week trials used to determine Prozac's efficacy.

Because of the high dropout rates and because Prozac was often no better than place-bo in many trials, many statistical maneuvers were required to make the studies look positive. In one of the key studies, involving six different sites around the country, results at five sites showed Prozac to have no benefit. One site--representing 25 percent of the patients who finished the trials--was discarded. Then the data from the remaining sites were pooled. This is such a scientifically unacceptable practice that the FDA prohibits drug companies from doing it in the studies used to support advertising claims. Yet the FDA allowed it in this case. Otherwise Prozac could not have been approved.

If Prozac was largely ineffective in the FDA studies, how and why has it become so popular? Controlled studies routinely show that placebo is highly effective in relieving depression. When a drug becomes a social fad, placebo can gain miraculous powers.

There is, however, another, more disquieting reason for Prozac's popularity. The FDA's own analysis--expunged from its published conclusions--originally determined that Prozac is a stimulant-like drug. Nearly all of Prozac's clearly established effects are indistinguishable from those of classic stimulants such as the amphetamines and cocaine: activation or energizing, nervousness, anxiety, agitation, insomnia, nightmares, sweating, anorexia, weight loss, and in the extreme, hypomania and mania. There is also evidence that Prozac can produce behavioral abnormalities consistent with stimulants including paranoia and violence, and crashing, with depression and suicidality.

Americans have always loved stimulants. During the 1960s, amphetamines were prescribed in even greater numbers than Prozac, and they were touted for the same disorders, including depression and fatigue. Cosmetic psychopharmacology, presented as a unique Prozac phenomenon, has a long history in association with stimulants. Sigmund Freud, as he became hooked on cocaine, wrote glowingly about how it transformed his personality entirely for the better without any negative side effects.

Prozac's seemingly good effects are probably based on a combination of placebo and stimulation, with no specific "antidepressant" effect. Being artifically jazzed up can be tempting for meeting the demands of our high-stress, high-production lifestyles.

Many people do not feel high or euphoric on Prozac, but react with a narrowing of their emotional spectrum. They lose touch with themselves and others, and may perceive this as a kind of relief. Commonly, Prozac--like other stimulants--acts as an "anti-empathy" agent. It disconnects a person from the rest of the world and from his or her own real-life issues.

Sometimes it dulls the perception of emotional despair. Other times it produces an artificial euphoria that can progress toward mania. At best, people who use Prozac may become "better adjusted" to circumstances that do not truly meet their needs or fulfill their ideals. Worse, an individual can develop drug-induced apathy or euphoria.

Since recorded time, humankind has suffered from depression. Many individuals can recall periods in their lives when they were depressed (try remembering adolescence, for instance). Usually through the personal evolution of one's life, the sadness passes. Sometimes therapy, a spiritual awakening, or life changes help restore or initiate a more enthusiastic, hopeful outlook. Depression--and its mirror image, enthusiastic involvement in life--are the result of a complex interrelationship of environmental, social, spiritual, psychological, and sometimes physical factors.

Despite the enthusiasm with which the psychiatric community has embraced the biological theory of depression, it remains unproven. No genetic factors have been proven in depression or in the severe mood swings of manic depression despite 200 years of claims. At times, depression is produced by a recognized hormonal flaw such as hypothyroidism, which should be treated medically.

The emotional factors in depression are well known. From chimpanzees in the wild to human children enduring institutional care, it has been shown that most higher animals respond to the loss of love, liberty, or hope with degrees of depression that can become life-threatening. When so many Americans feel depressed and hopeless, we are dealing with a social phenomenon. The very idea that drugs are the answer suggests a moral, psychological, or spiritual vacuum.

That the specific causes of depression in our own lives often seem mysterious to as is no surprise. At the root of depression is a feeling of helplessness in the face of life--a sense that nothing can be done to make life worth living. If the causes of despair were known to us, we might feel frightened, but not be as like lapse into hopelessness.

Depression tells us that something is the matter with our lives. It can be a signal for personal transformation. In therapy as well as in other approaches to life improvement, overcoming depression often means finding greater appreciation for oneself and all other aspects of life, plus increased determination to live in a more self-fulfilling and loving way.

Is Prozac a short-cut to happiness? There can be no quick fixes of the human spirit. With or without drugs happiness can not be directly sought It comes, if at all, as a bonus for living a principled, rational, and loving life. The frailty and elusiveness of happiness is a tragic reality. Even wisdom, ethics, and courage cannot guarantee it.

Golda Meir once said, "Those who do not know how to weep with their whole heart don't know how to laugh either." Today we view depression and all distress in a medicalized way, divorced from our personal histories and family background, our ongoing conflicts and circumstances, and the values of the society in which we live. Instead of doing the tough work of self-transformation, we blame biochemistry.

When mental health professionals point to spurious genetic and biochemical causes, they encourage psychological helplessness and discourage personal and social growth. Even if we feel "better adjusted; we have not faced what life is all about--finding our own ethical and spiritual path, the one that brings enthusiasm and hope to all we do.