Free drug trials are advertised on radio and television and in the newspapers. Upon telephoning the investigator, a potential participant in one of these trials would undergo a ten-minute screening interview on the phone, during which the new drug, the nature of the study, and the possibility of being assigned to a placebo would be explained, along with the rights of patients who volunteer, including the right to discontinue the drug at any time. If the screening interview looks promising, the patient is asked to come in for a more detailed psychiatric interview. Thereafter, a medical exam, including an EKG, is performed to see if the patient is truly eligible. If the patient meets the criteria, he or she is asked to sign a one or two-page informed consent document about the study.

Clinical drug studies generally fall into three categories. In phase I studies, patients in the hospital are treated with drugs in their earliest state of clinical development to determine dosages and safety. In phase II studies, both hospitalized patients and outpatients are given low, medium, or high doses to check for efficacy, tolerance, and side effects. In phase III studies, investigators usually compare the new drug to a placebo and to one or two other standard drugs that have been marketed for several years. Large numbers of outpatients in eight to ten centers throughout the country participate thereafter in a six-to eight-week trial. Most new drug studies go through these final phases of development prior to I approval by the PDA for marketing. In phase IV, drug studies take place after marketing in order 10 investigate the medication’s potential usefulness with diseases other than the initial illness for which the FDA gave its approval. The people who participate in these antidepressant trials may include treatment-resistant patients who have tried other antidepressants, including tricyclics, MAOIs and SSRIs, all without success. For them a new drug trial is the court of last appeal. The lack of cost to the participants and the extraordinary attention they receive from highly qualified doctors and nurses are major factors in the patient’s motivation to participate.

*110\22\4*

In the more than forty years since the discovery and later the widespread use of lithium for manic depression, scientific and clinical case studies have been accumulating rapidly, showing a high rate of severe mood disorders and suicides among artists, composers, sculptors, and writers. Researchers at the University of Kentucky Medical Center reviewed the lives of over a thousand accomplished people in a variety of fields, including Henri Matisse, Aldous Huxley, and Albert Einstein. 17% of the actors and 13% of the poets were manic-depressives—but only about 1% of the scientists. Other studies have found mat manic depression and major depression are as much as ten to thirty times more frequent among noted artists than among the population as a whole.

A study matching thirty members of the Iowa Writers Workshop with thirty nonwriters revealed that 80% of the writers—but only 30% of the non-writers—reported at least one episode of depression’ or manic depression (30% of the writers but only 6% of the controls, were alcoholic). In addition, the parents and siblings of the writers were significantly more creative and more prone to highs and lows than the relatives of the nonwriters. For instance, 20% of the writers’ brothers and sisters, but only 3% of the siblings of the control population, had a mood disorder; 14% of the writers’ siblings had experienced major depression, versus 3% of the control siblings.

This data strongly suggests a genetic link between mania, depression, and artistic creativity.

*90\22\4*

The attack against Prozac was launched in November 1989 by the Church of Scientology, a group characterized by die Wall Street Journal as “a quasi-religious/business/paramilitary organization” and defined by Funk and Wagnall’s 1984 New Comprehensive International Dictionary as “a religious and psychotherapeutic cult purporting to solve personal problems, cure mental and physical disorders, and increase intelligence.” Founded by L. Ron Hubbard, a science fiction writer who died in 1986, Scientology considers its doctrines to be, as the subtitle of Hubbard’s book Dianetics explains, “the modern science of mental health.” After that book’s publication in 1950, mental health professionals spoke out against Scientology. Perhaps in retaliation. Scientologists have long counted psychiatrists, psychiatric medications, and pharmaceutical companies among their many enemies. Prozac, a spokesman alleged, was a “killer drug.”

Leading the Scientology attack against Prozac is the Citizens Commission on Human Rights (CCHR), a group which was founded by Scientology in 1969 and which had in the past attacked the amphetaminelike drug Ritalin (widely used for helping hyperactive children achieve a normal attention span.) Once the CCHR set its sights on Prozac, it lobbied against it, sent out mass mailings, and, in October 1990, filed a citizen’s petition with the Food and Drug Administration requesting the withdrawal of Prozac from the market—only a few months after the FDA reaffirmed Prozac’s safety and efficacy as an antidepressant.

As ammunition, the CCHR made extensive use of an article published in February 1990 in the American Journal of Psychiatry by several Boston psychiatrists. The report stated that after two to seven weeks on Prozac, six out of 172 high-risk mental patients who had not been responsive to other drugs became preoccupied with violent, obsessive suicidal thoughts, and that two of them tried (without success) to kill themselves.

Nothing about this was in the least extraordinary to psychiatrists who are familiar with and treat depression. Depressed people are often suicidal: it’s a symptom of the disease. About 15% of patients with diagnosed depression eventually commit suicide; about 80% of all patients who commit suicide or make a serious attempt to do so are depressed. At the time and now, most leading psychopharmacologists in the United States felt that it was not a surprise that a few of the deeply depressed patients in the Boston study were suicidal. In addition, four of the six were taking other medications (in one case, five other medications). It was also noted that, although none of these patients seemed suicidal when they began taking Prozac, five of the six had had suicidal thoughts in the past.

Nonetheless, because serotonin, the neurotransmitter Prozac specifically affects, may be linked with aggression, there was reason for concern. It was speculated that in a few instances, Prozac might “tip the balance in the wrong direction, toward violence and aggression.”

When the article came to the attention of the CCHR, they took the figures, which were based on a small group of nonresponsive mental patients, and extrapolated them to the entire population. Using the article’s statistics, they asserted not only that “up to 140,000 people in the United States have become violent and suicidal by Prozac” but also that Prozac could easily promote killing sprees, a prediction they backed up with one unique story of mass murderer Joseph Wesbecker. In 1989, Wesbecker attacked his co-workers at the Standard Gravure printing plant in Louisville, Kentucky. Using an AK-47 assault rifle, be killed eight, wounded twelve, and then shot himself.

Why did he do this? Speaking on the “Phil Donahue Show,” Dennis Clarke, president of the CCHR, announced that he did it because he was taking Prozac. Before that, Clarke said, Wesbecker “had no history of violence.”

However, as the Wall Street Journal revealed in April 1991, this was completely untrue. Wesbecker had made twelve previous suicide attempts, had often talked of killing his employers, and had accumulated a collection of guns, with which he regularly practiced shooting—all before he started taking Prozac.

The attack on Prozac was well under way when, on May 6, 1991, Time magazine ran a cover story entitled “Scientology: The Cult of Creed.” The

Church of Scientology struck back with a $3 million ad campaign in USA Today that suggested that Time had attempted to forward Hitler and included an attack against Eli Lilly, the manufacturer of Prozac.

The result of all this? Sales of Prozac, by then a full 25 percent of the antidepressant market slipped to 21 percent. In a dozen cases around the nation, defense attorneys argued that their clients were not responsible for their actions because they had been taking Prozac. Even more disturbing to me and other psychiatrists, many patients decided on their own to discontinue the drug, with the predictable result that their depression worsened and in some cases their suicidal thoughts became more intense. Worst of all, some patients needed to be hospitalized as a result of going off their medication.

In July 1991, the FDA rejected the CCHR petitions, once again reaffirming the safety of Prozac. Two months later, the FDA Advisory Committee and an independent scientific advisory committee unanimously announced that Prozac and other antidepressants do not cause suicide or violent behavior, in fact, Prozac seemed to protect against violent behavior, and large clinical trials indicate that patients taking Prozac are actually less suicidal than those taking a placebo or other antidepressant drugs.

Nonetheless, the CCHR and a handful of attorneys have continued this campaign against Prozac, twisting the scientific data, misrepresenting the clinical experience, and discouraging patients from taking a drug that has been accepted in more than sixty-three countries around the world as a safe and effective way to treat depression. The anti-Prozac campaign has been thoroughly discredited by the FDA, the American Psychiatric Association, and all leading medical authorities. Unfortunately, the ultimate victims of the disinformation campaign are the patients, their families, and the medical profession.

*70\22\4*

Depressed people are sometimes told to “buck up”, snap out of it, quit whining, or get their act together. But it doesn’t work that way. Major depression is a physiological condition, many varieties of which have been shown to be genetically inherited. It is characterized by disturbances of appetite, sex, sleep, and mood, all of which appear to have their primary location in an area of the brain called the hypothalamus, which acts as a control center for these physiological functions and needs and is influenced by other biochemical processes in die brain and the body. Major depression is not just a psychological reaction to some real or imaginary loss; it is biological with psychological components and effects. The sole use of Prozac (and other antidepressants) depends in part on the patient’s physical health.

Is it safe to take Prozac and other medications at the same time? The more medications a person is taking, the greater the chance for potential problems. Drugs interact. So whenever a second medication is in the body, it should mean extra caution on the part of the physician and patient. Potential drug interactions should always be researched by the treating physician.

Has Prozac had any effect on male or female reproduction or fertility? Limited studies have shown no effect on reproductive functioning or fertility in bow sexes. Men are able to take Prozac throughout their reproductive life without any harmful effects on sperm count.

Does Prozac damage the brain? No brain damage whatsoever has been detected in animal or human studies, even after Prozac has been given in doses many times higher than that which is normally considered safe.

*48\22\4*

Because studies have not correlated a specific blood level of Prozac with therapeutic results, blood tests are not routinely taken. This is in direct contrast to some other antidepressants. For instance, with at least four tricyclic antidepressants (imipramine, desipramine, nortriptyline, and amitriptyline), blood levels may be routinely taken by some psychiatrists, including myself, because certain levels are needed to achieve a therapeutic window effect, and hence the blood test serves as a guide to the psychiatrist as to the dosage required.

With Prozac, on the other hand, the appropriate dosage, for the most part, corresponds simply to weight and age. Patients of average age and weight (for men that is 150 pounds, mean age 35; for women that is 120 pounds, mean age 35) need approximately 20 mg of Prozac a day, with the very young and very old taking smaller doses. But the average dose is not necessarily the correct one for a given individual. Ultimately, the way a patient feels is the most important determinant of the final dosage, along with the patient’s specific metabolism and genetic factors.

*29\22\4*