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Talking Back to Prozac
What Doctor Won't Tell You About Today's Most Controversial Drug
By Peter R. Breggin, Ginger Ross Breggin OPEN ROAD INTEGRATED MEDIA
Copyright © 1994 Peter R. Breggin, M.D., and Ginger Ross Breggin
All rights reserved.
ISBN: 978-1-4976-1748-3
CHAPTER 1
Should We Listen to Prozac?
Nearly everyone knows someone who is taking Prozac. In urban centers, where Prozac has achieved fadlike status, most people can name several friends or coworkers who are taking the medication. Among teenagers in our suburban hometown, Prozac is also a familiar drug. The youngsters tend to know many friends who are on it.
One of my patients recently told me, "Nearly everyone in my office is on it." She was experiencing peer pressure to take a prescription medication. Convinced of its safety, some people casually share their pills with friends who seem depressed.
As a recent New York Times headline announced, "With Millions Taking Prozac, A Legal Drug Culture Arises." Columnists are joking about putting it in the drinking water.
Prozac is becoming America's drug.
A Brief History of Prozac ... Or, the Making of a Miracle Drug
Currently the most widely prescribed and controversial psychiatric drug, Prozac began its life in the research laboratories of Eli Lilly & Company. A Lilly researcher named D. T. Wong published the first article about the drug in 1974. In 1975 it was given the official chemical name fluoxetine and later the company selected the trade name Prozac.
In February 1977, Dista Products Company, a division of Eli Lilly & Company, submitted a new drug application to the Food and Drug Administration (FDA) for Prozac. This initiated the lengthy approval process through the government agency. By April 1981 the FDA gave permission for Phase III, the controlled clinical trials, to begin. The trials were organized, supervised, funded, and evaluated by Lilly (chapter 3 provides a more complete discussion of these trials). They lasted through the end of 1982. In the ensuing several years, Eli Lilly and the FDA evaluated the studies and collected other information relevant to drug approval.
In October 1985, the FDA gave initial approval to Prozac. Their final approval letter was sent to Lilly in late December 1987, and Lilly began marketing the drug in January 1988. From discovery to marketing, Prozac's gestation lasted more than a dozen years. The FDA approval process lasted more than a decade. But within only a few months of its introduction for consumer use, Prozac was well on its way to fame (and fortune).
By 1989, annual sales for the drug had reached $350 million—more than the total amount previously spent annually by Americans on all antidepressants combined. At that point, Prozac already represented more than one-tenth of Lilly's $4.18 billion in annual sales. Despite growing controversy about Prozac-related murder and suicide, sales of the drug in 1990 doubled over those of the previous year. At that time Lilly reported that 650,000 prescriptions were being written each month.
On March 26, 1990, Newsweek put a huge Prozac capsule on its cover with a subhead announcing, "A Breakthrough Drug for Depression." The story, by reporter Geoffrey Cowley, displayed the photo of a smiling woman, captioned, "I'm nowhere near perfect, but it's a big, big improvement." Seemingly without embarrassment, Newsweek reported how another woman exclaimed, "I call myself Ms. Prozac." The magazine anticipated that "these breakthrough drugs may change the lives of millions." It's no coincidence that in 1991 and 1992, Prozac gave Lilly a nearly $1 billion share of the $8 billion antidepressant market.
In 1993, Prozac gained an even higher profile with the publication of psychiatrist Peter Kramer's Listening to Prozac. Kramer described some Prozac users as feeling "better than ever" or "more like my true self." Listening to Prozac spent twenty-one weeks on the New York Times bestseller list.
Prozac's 1993 annual sales reached nearly $1.2 billion. This figure represents an increasing proportion of the company's total revenues, which rose to $6 billion in that year. Toward the end of 1993, it was estimated that 6 million Americans and an additional 4 million people worldwide had taken the antidepressant, with no end in sight to the mounting numbers.
Prozac is now the most frequently prescribed psychiatric drug. Physicians, mostly non-psychiatrists, are now writing almost one million prescriptions a month for the drug, which retails in most areas for approximately $63 for a one-month, one-a-day, supply of 20 mg. capsules. The recent FDA approval of Prozac for the treatment of obsessive-compulsive disorder and for bulimia will probably lead to another escalation in sales.
Prozac's newly arrived competitors have begun to vie for a share of the market in this new class of drugs called SSRIs (selective serotonin reuptake inhibitors). Zoloft, whose chemical name is sertraline, is a product of Roerig, a division of Pfizer, Incorporated. Approved by the FDA in December 1991, it reached annual sales of $195 million in 1992. Industry analysts predict it will achieve the $800 million mark by 1997. Paxil, or paroxetine, manufactured and distributed by SmithKline Beecham, was the next SSRI to receive FDA approval. Pfizer and SmithKline Beecham are both even larger than Lilly, each with annual revenues exceeding $7 billion. These three giants are Fortune 500 companies and have the capacity to exert considerable influence upon the medical and psychiatric professions; state and federal governments, including both houses of Congress; print and electronic media; the public; and, as we shall see, even the court system.
Two other Prozac-like SSRIs are coming into the marketplace. Luvox (fluvoxamine) has recently been approved by the FDA for obsessive-compulsive disorder and is already in use in Canada and elsewhere as an antidepressant. Serzone (nefaza-done) is undergoing FDA approval for depression.
Once a drug is approved for marketing by the FDA, there are no government controls over what the physician can prescribe it for. While Prozac was originally approved for depression—and only recently for obsessive-compulsive disorder—it and the other SSRIs quickly began to be prescribed for a wide variety of ailments and difficulties, such as seasonal affective disorder (SAD) or "winter blues," obesity, anorexia, bulimia, phobia, anxiety and panic disorder, chronic fatigue syndrome, premenstrual syndrome (PMS), postpartum depression, drug and alcohol addiction, migraine headaches, arthritis, body dysmorphic disorder (BBD), and, finally, behavioral and emotional problems in children and adolescents.
With the publication of Peter Kramer's book, Prozac entered a new phase. It became a drug for enhancing the lives of people who otherwise consider themselves normal. Super qualities that users and addicts typically attribute to illicit or recreational drugs, from alcohol to cocaine, began to be attributed to Prozac.
The winter of 1993-1994 saw a new explosion of promotion and controversy surrounding Prozac as well as Zoloft and Paxil. Riding on the success of Listening to Prozac, on February 7, 1994, Newsweek published yet another major story on the pill by Geoffrey Cowley. Emblazoned on the cover was "Beyond Prozac," and the cover copy captured the nation's new preoccupation— Prozac for personality enhancement:
SHY?
FORGETFUL?
ANXIOUS?
FEARFUL?
OBSESSED?
HOW SCIENCE
WILL LET YOU
CHANGE YOUR
PERSONALITY
WITH A PILL
A series of extraordinarily laudatory TV news stories followed. One of them, billed as an expose, trooped a series of grinning Prozac consumers across the screen. As the only criticism, the show's analyst wondered if there wasn't something inherently immoral about a drug that was so wonderful. Another show raised the question of unfairness. Because of their increased alertness and drive, weren't Prozac users getting an unfair advantage in the business world? Would everyone feel compelled to take it just to keep up with the competition?
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 by the TV news camera, including large numbers of people who said that they or their family members had been 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. Meanwhile, the usual flurries of print media inquiries had turned into an avalanche at our nonprofit research and educational institute, the Center for the Study of Psychiatry.
The Prozac controversy reached ludicrous heights in early 1994 when psychologist James D. Goodwin gained national recognition as the "Pied Piper of Prozac," amid charges brought against him by his state psychology board that claimed he was diagnosing patients too quickly and was too often recommending Prozac. Since starting his practice of clinical psychology in the Apple Capital of the World, the small town of Wenatchee, Washington, Goodwin has referred 700 to 800 patients to physicians for the prescription of Prozac.
When Peter Kramer and I appeared on Oprah Winfrey's television talk show on March 7, 1994, Goodwin was seen from Wenatchee via satellite with a roomful of adoring Prozac patients. Goodwin presented a twelve-year-old girl who seemed to recite prepared statements as to how the drug had saved her. Other of his patients came to Chicago to be on the show and joined a large group of Prozac users, many of whom seemed both euphoric and hostile. It struck me, and I suggested on Oprah, that Goodwin was leading what's tantamount to a Prozac cult.
In a March 3, 1994, Associated Press release, writer Aviva Brandt began her story by noting that Goodwin had been "accused of urging the antidepressant drug too forcefully on patients and without adequate evaluation of their condition." She then continued, in obvious dismay, "It took him 15 minutes to suggest I try Prozac to relieve what he called a 'mild form of depression.'"
Goodwin states that he himself has been taking Prozac for years. Some people taking Prozac, as we shall document, develop social insensitivity, lack of judgment, and self-destructive, grandiose claims and actions.
Recently Eli Lilly began to show concern about the growing tendency to advocate Prozac as a personality enhancer. In a full-page ad in the March 18, 1994, Psychiatric News, the official newspaper of the American Psychiatric Association, the drug company decried "trivializing a serious illness" in the media. The ad asserted, "Much of this attention has trivialized the very serious nature of the disease Prozac was specifically developed to treat—clinical depression."
Psychiatrists justify using antidepressants on the grounds that depression is a biochemical disorder. Perhaps Lilly feared that the medical aura surrounding the drug was being discredited by overly enthusiastic advocates. The company may also have feared that people would begin to take seriously the comparison I was making in the media between Prozac and classical stimulants, such as amphetamines and cocaine.
Is Wenatchee, Washington, merely an exaggerated microcosm of America's enthusiastic acceptance of Prozac? Is Brave New World a real possibility? What is the tradeoff, mentally and morally, when a person seems to feel better on any drug and on Prozac in particular? What does Prozac do to the capacity for empathy and love? To self-reflection? What does it mean to be "euphoric," and are there gradations of euphoria too subtle for most doctors and patients to recognize? How does drug euphoria differ from genuine happiness?
The Prozac craze at first suggests a radical change in America's thinking and even in public policy. It used to be that we suspected and even vilified drugs that "just made you feel good." The government outlawed them. And 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 potentially dangerous implications in the popularity of this new drug. As a result of the avalanche of adverse publicity, including medical and media reports of violence and suicide, the FDA felt compelled to hold hearings on Prozac in 1991.
Dozens of Prozac survivors, their families, and friends, traveled from across the country to give five-minute accounts of their painful and sometimes deadly encounters with the drug. Nancy Veasey, a registered nurse in Philadelphia, testified to the FDA committee:
In September of 1990 an article appeared in the Philadelphia Enquirer. As a result of that, the Prozac Survivors Group in the Philadelphia area was launched.... I met and talked with by phone 15 people directly and indirectly affected by the drug, not a very impressive group, but what is impressive is that out of the 15 there are five deaths recorded in my notes. These are the facts.
A 36-year-old mother of two, while on Prozac, attempted suicide by impulsively ingesting a toxic dose of medication.
A 42-year-old man watched helplessly as his 36-year-old wife casually, with no warning, picked up a knife and cut both her wrists while on Prozac.
A 50-year-old man with some memory impairment struggles today to express the devastating and long-lasting effect of this drug.
A 49-year-old man, while on Prozac, blacked out while driving and was involved in a car accident.
A 71-year-old man shot himself seven days after being prescribed Prozac, one week before his daughter's wedding.
A 58-year-old man, while on Prozac, developed violent behavior directed toward his sister, his primary caretaker. He was hospitalized. He has since died.
The mother of a 40-year-old Harvard physician found her daughter dead. On the nightstand was a bottle labeled Prozac. The coroner's report showed excessive amounts of Prozac in the blood. Just three months ago, upon receiving her daughter's effects, her grief-stricken husband died. Needless to say, this is one woman who is literally immobilized by grief, as I am sure many others here today are.
In June of this year a woman found her husband dead by hanging in the basement of their home one week after Prozac was prescribed for him. There were no signs or warning signals. He simply got up, as he did frequently at night, and went downstairs and hung himself. His son cannot go down there to this day.
In an interview with Ginger Breggin, Nancy explained that Prozac had adversely affected a family member, leading her to seek contact with other survivors of Prozac, and ultimately to become a leader in the reform movement.
Prozac's horizon is full of storm warnings —including many tragedies that have already struck. In addition to the more dramatic cases of murder and suicide attributed to Prozac that have made the news, Eli Lilly declared in its 1992 annual report to the Securities and Exchange Commission that in "approximately 170 actions, plaintiffs seek to recover damages as a result of the ingestion of Prozac." It adds, "in the opinion of the company, such actions will not ultimately result in any liability that would have a material adverse effect on its consolidated financial position."
A 1990 report by Natalie Angier in the New York Times confirms that most of the suits against Lilly are related to violent behavior and thoughts, suicidal obsessions and acts, and self-mutilation. That most of the suits against Lilly involve allegations of violent or self-destructive behavior is further confirmed by my discussions and consultations with attorneys and clients who have brought suits or are initiating new ones against the drug company.
The suits against Lilly entail product liability in which the company is charged with failing to test the drug properly and failing to give proper warning of its adverse side effects, as well as negligence in regard to making, marketing, or promoting Prozac. The allegations often hinge on the drug company's promotional materials, specifically whether or not they sufficiently warn doctors, patients, and the public about drug-induced mental aberrations, including violence against self and others. As of now, to our knowledge none of these suits have come to trial.
(Continues...)
Excerpted from Talking Back to Prozac by Peter R. Breggin, Ginger Ross Breggin. Copyright © 1994 Peter R. Breggin, M.D., and Ginger Ross Breggin. Excerpted by permission of OPEN ROAD INTEGRATED MEDIA.
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