Anatomy of an Epidemic (45 page)

The atypical revolution was on. Risperdal apparently restored sanity by balancing
multiple
neurotransmitters in the brain, and it seemed to cause
no
side effects of any note. In 1996, Eli Lilly brought Zyprexa (olanzapine) to market, and the public story of the wonders of atypicals got ramped up another notch.

As had become customary, Eli Lilly employed trials that were “biased by design” against haloperidol, the FDA concluded. As a result, its large phase III trial, which wasn’t placebo controlled, provided “little useful efficacy data.” As for olanzapine’s safety profile, twenty patients treated with the drug during the trials died, 22 percent suffered a “serious” adverse event (higher than in the haloperidol patients), and two-thirds failed to complete the studies. Olanzapine, the data suggested, made patients sleepy and fat, and caused such problems as Parkinsonian symptoms, akathisia, dystonia, hypotension, constipation, tachycardia, diabetes, seizures, leaking breasts, impotence, liver abnormalities, and white blood cell disorders. Furthermore, warned the FDA’s Paul Leber, since olanzapine blocked receptors for many types of neurotransmitters, “no one should be surprised if, upon marketing, events of all kinds and severity not previously identified are reported in association with olanzapine’s use.”
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That was the story told by the trial data. The story that Eli Lilly wanted to appear in the medical journals and newspapers was that Zyprexa was better than Janssen’s Risperdal, and so that’s the story that its hired guns told. Psychiatrists from academic medical schools announced that olanzapine worked in a more “comprehensive” manner than either risperidone or haloperidol. It was a well-tolerated agent that led to global improvement—it reduced positive symptoms, caused fewer motor side effects than other antipsychotics, and improved negative symptoms and cognitive function.
⁶⁵
This second atypical was better than the first, and the
Wall Street Journal
ran with that angle. Zyprexa, it announced, “has substantial advantages” over other current therapies. “The real world,” explained John Zajecka, from Rush Medical College, “is finding that Zyprexa has fewer extrapyramidal side effects than Risperdal.”
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Zyprexa is “a potential breakthrough of tremendous magnitude,” Stanford University psychiatrist Alan Schatzberg told the
New York Times
.
⁶⁷

The only question now seemed to be whether Zyprexa was truly better than Risperdal, and after AstraZeneca brought a third atypical to market, Seroquel, the media settled on the notion that collectively the new atypicals were a dramatic improvement over the older drugs. They were,
Parade
told its readers, “far safer and more effective in treating negative symptoms, such as difficulty in reasoning and speaking in an organized way.”
⁶⁸
The newer drugs, the
Chicago Tribune
announced, “are safer and more effective than older ones. They help people go to work.”
⁶⁹
Wrote the
Los Angeles Times
, “It used to be that schizophrenics were given no hope of improving. But now, thanks to new drugs and commitment, they’re moving back into society like never before.”
⁷⁰
NAMI chimed in, too, publishing a book titled
Breakthroughs in Antipsychotic Medications
, which helpfully explained that these new drugs “do a better job of balancing all of the brain chemicals, including dopamine and serotonin.”
⁷¹
On and on it went, and finally NAMI’s executive director, Laurie Flynn, told the press that the promised land had at last been reached: “These new drugs truly are a breakthrough. They mean we should finally be able to keep people out of the hospital, and it means that the long-term disability of schizophrenia can come to an end.”
⁷²

That was the sequence of storytelling that led to the explosive rise in the use of psychiatric drugs in the United States. First, American
psychiatrists touted Prozac as a wonder drug, next they hailed Xanax as a safe and effective therapy for panic disorder, and finally they informed the public that atypical antipsychotics were “breakthrough” medications for schizophrenia. In this way, they rejuvenated the market for psychiatric medications, even though the clinical studies of the new drugs had not told of any therapeutic advance.

At least in scientific circles, the “wonder drug” glow around the second-generation psychotropics has long since disappeared. As we learned earlier, the SSRIs were reported in 2008 to provide a meaningful clinical benefit only to severely depressed patients. Xanax is now understood to be much more addictive than Valium, with various investigators determining that two-thirds of people who take it for any length of time have trouble getting off it.
⁷³
As for the top-selling atypicals, the hyping of these drugs is now viewed as one of the more embarrassing episodes in psychiatry’s history, as one government-funded study after another failed to find that they were any better than the first-generation antipsychotics. In 2005, the NIMH’s “CATIE Trial” determined that there were “no significant differences” between the atypicals and their predecessors, and even more troubling, in this study neither the new drugs nor the old ones could really be said to work. Seventy-four percent of the 1,432 patients were unable to stay on the medications, mostly because of their “inefficacy or intolerable side effects.”
⁷⁴
A study by the U.S. Department of Veterans Affairs came to a similar conclusion about the relative merits of atypicals and the older drugs, and then, in 2007, British psychiatrists reported that schizophrenia patients, if anything, had a better “quality of life” on the old drugs than on the new ones.
⁷⁵
All of this led two prominent psychiatrists to write in the
Lancet
that the story of the atypicals as breakthrough medications could now be “regarded as invention only,” a tale concocted “by the drug industry for marketing purposes and only now being exposed.” Yet, they wondered, “how is it that for nearly two decades we have, as some have put it, ‘been beguiled’ into thinking they were superior?”
⁷⁶

History, as readers of this book can attest, reveals the answer to that question. The seed for the atypicals story was planted in the
early 1980s, when the APA embraced “biological psychiatry” as a story that could be successfully marketed to the public. This was also a story that the field, as a whole, desperately wanted to believe in, and soon Nancy Andreasen and others were telling of a revolution that was under way, with mental illnesses finally giving up their biological secrets, even though nobody could precisely explain what those secrets were. That story gained steam, prepping the public to believe that therapeutic advances were on the way, and as pharmaceutical companies brought new medications to market, they hired the top psychiatrists in the country to tell of how these new wondrous drugs “balanced” brain chemistry. And it was that co-opting of academic medicine that gave the story its credibility. This was a story told by
Harvard Medical School
psychiatrist Jerrold Rosenbaum, by former
NIMH director
Gerald Klerman, and by
Stanford University
psychiatrist Alan Schatzberg.

Of course we, as a society, believed it.

As we have seen, American psychiatry has told the public a false story over the past thirty years. The field promoted the idea that its drugs fix chemical imbalances in the brain when they do no such thing, and it grossly exaggerated the merits of the second-generation psycho tropics. In order to keep that tale of scientific progress afloat (and to protect its own belief in that tale), it has needed to squelch talk about the harm that the drugs can cause.

Psychiatry’s policing of its own ranks began in earnest in the late 1970s, when Loren Mosher was ousted from the NIMH for having run his Soteria experiment. The next prominent psychiatrist to end up on psychiatry’s hit list was Peter Breggin. Although he is known today for his “antipsychiatry” writings, he, too, had once been on the fast track at the NIMH. After finishing his residency at a Harvard Medical School hospital, Breggin went to the NIMH in 1966 to work on developing community mental health centers. “I was still the young hotshot guy,” he recalled, in an interview. “I thought
I would be the youngest professor of psychiatry in the history of Harvard Medical School. That was the trajectory I was on.”
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However, he saw that the future belonged to biological psychiatry, as opposed to the social psychiatry that interested him, and he left the NIMH to go into private practice. Soon he began writing about the hazards of electroshock and psychiatric drugs, which, he argued, “worked” by disabling the brain. After a number of heated battles with the APA’s leaders, Breggin appeared in 1987 on Oprah Winfrey’s television show, where he spoke about tardive dyskinesia and how that dysfunction was evidence that neuroleptics damaged the brain. His comments so infuriated the APA that it sent a transcript of the show to NAMI, which in turn filed a complaint with the Maryland State Commission on Medical Discipline, asking that it take away Breggin’s medical license on the grounds that his statements had caused schizophrenia patients to stop taking their medications (and thus caused harm). Although the commission decided not to take any action, it did conduct an inquiry (rather than summarily dismissing NAMI’s complaint), and the message to everyone in the field was, once again, quite clear.

“I think the interesting thing is that Loren [Mosher] and I took on scientifically the two sides of the issue,” Breggin said. “Loren took on the issue that there is a better treatment than drugs for schizophrenia. I took on the treatments—the drugs, electroshock, and psychosurgery. And what this showed is that it didn’t matter which end you wanted to take, they were willing to destroy your career. That is the lesson.”

The career setback that Irish psychiatrist David Healy experienced was, in some ways, reminiscent of Mosher’s fall from grace. During the 1990s, he earned a reputation as one of the field’s leading historians, his writings focusing on the psychopharmacology era. He had served as secretary of the British Association for Psychopharmacology, and in early 2000, he accepted an offer from the University of Toronto’s Centre for Addiction and Mental Health to head up its mood and anxiety program. Up until that moment, he was very much part of the psychiatric establishment, just as Mosher had been. However, for several years he had been interested in the question of whether SSRIs could stir suicide, and he had recently
completed a “healthy volunteers” study. Two of the twenty volunteers had become suicidal after they were exposed to an SSRI, which clearly showed that the drug could cause such thoughts. Not long after he accepted the Toronto job, he presented his results at a meeting of the British Association for Psychopharmacology. There, one of the most prominent figures in American psychiatry warned him to knock it off. “He told me that my career would be destroyed if I kept on showing results like the ones I’d just shown, that I had no right to bring out hazards of the pills like these,” Healy said.
⁷⁸

In November of 2000, only a few months before he was scheduled to start his new job at the University of Toronto, Healy gave a talk on the history of psychopharmacology at a colloquium organized by the school. In his presentation, Healy spoke about problems that had arisen with neuroleptics since their introduction in the 1950s, briefly reviewed the data showing that Prozac and other SSRIs elevated the risk of suicide, and then observed in passing that outcomes for affective disorders are worse today than they were a century ago. This, he observed, shouldn’t be happening if “our drugs really worked.”
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Although the audience subsequently rated his talk as the colloquium’s best for content, by the time Healy arrived back in Wales, the University of Toronto had rescinded the job offer. “While you are held in high regard as a scholar of the history of modern psychiatry, we do not feel your approach is compatible with the goals for development of the academic and clinical resources that we have,” wrote the Centre’s head psychiatrist, David Goldbloom, in an e-mail.
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Once more, others in the field could draw only one lesson. “The message is that it is a bad idea to speak out, and that the idea that treatments might not work or might not be best managed by being entrusted to doctors is beyond the pale,” Healy said in an interview.
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Numerous others can attest to the fact that it is a “bad idea” to speak out. Nadine Lambert, a psychologist at the University of California at Berkeley, conducted a long-term study of children treated with Ritalin and found that, as young adults, they had elevated rates of cocaine abuse and cigarette smoking. After she reported her results at a 1998 NIH conference, the National Institute on Drug
Abuse stopped funding her work. In 2000, when Joseph Glenmullen, a clinical instructor in psychiatry at Harvard Medical School, authored
Prozac Backlash
, which detailed the many problems associated with the use of SSRIs, Eli Lilly mounted a campaign to discredit him. A public-relations firm gathered critical comments from several prominent psychiatrists, who derided Glenmullen as a “nobody” in the field, and then it mailed these “reviews” to various newspapers. “It’s a dishonest book, it’s manipulative, it’s mischievous,” said Harvard Medical School psychiatrist Jerrold Rosenbaum, even though he was a colleague of Glenmullen’s. The press release naturally did not mention that Rosenbaum was an Eli Lilly consultant.
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Next up on the chopping block: Gretchen LeFever, a psychologist at East Virginia Medical School. After she published research showing that an overly high number of children in Virginia schools were being diagnosed with ADHD, an anonymous “whistle-blower” charged her with scientific misconduct. Her federal research funds were cut off and her computers were seized, and while she was subsequently cleared of any misconduct, her career had still been derailed.