Anatomy of an Epidemic (43 page)

The first account of a U.S. trial of fluoxetine appeared in the
Journal of Clinical Psychiatry
in 1984. This novel agent, wrote James Bremner, from Northwest Psychopharmacology Research in Washington, “provides effective antidepressant activity with fewer and less troublesome side effects than imipramine…. None of the adverse events reported by fluoxetine patients were considered to be drug related.” Fluoxetine, he added, “proved more effective than the tricyclic antidepressant.”
²⁰
Next, John Feigner, from the University of California at San Diego, reported that fluoxetine was at least equal in efficacy to imipramine (and probably superior to the tri-cyclic) and that “no serious side effects were observed” in his twenty-two fluoxetine patients during a five-week study.
²¹
A theme had been sounded—a very safe and improved antidepressant had been developed—and Eli Lilly’s investigators stuck to it in the years that followed. “Fluoxetine was better tolerated than imipramine,” California psychiatrist Jay Cohn reported in 1985.
²²
“This drug,” said Eli Lilly’s Joachim Wernicke, in another article in the
Journal of Clinical Psychiatry
, “has very few serious side effects.”
²³
Finally, in the 1985 report on its large phase III trial, Eli Lilly announced that “fluoxetine produced greater improvement than placebo on all major efficacy parameters.”
²⁴

While these reports did tell of a new drug that was superior to the old class of antidepressants, this still was not a narrative of a
“breakthrough” medication. There was no sense of
why
this drug worked better, but as FDA approval for fluoxetine neared, a new “fact” began to appear in the scientific reports. In a 1987 article in the
British Journal of Psychiatry
, Sidney Levine wrote that “studies have shown that [serotonin] deficiency plays an important role in the psychobiology of depressive illness.”
²⁵
While this was not what had actually been found—Levine had apparently missed the 1984 NIMH report that “elevations or decrements in the functioning of serotonergic systems per se are not likely to be associated with depression”—this article set the stage for fluoxetine to be touted as a drug that fixed a chemical imbalance. Two years later, University of Louisville psychiatrists surveyed the fluoxetine literature in order to provide “prescribing guidelines for the newest antidepressant,” and they wrote that “depressed patients have lower than normal concentrations of [serotonin metabolites] in their cerebrospinal fluid.” A delusional belief was now spreading through the medical literature, and perhaps not surprisingly, the Kentucky psychiatrists concluded that fluoxetine, which theoretically raised serotonin levels, was “an ideal drug for the treatment of depression.”
²⁶

This trail of reports in medical journals provided Eli Lilly with the sound bites it needed to advertise its drug to doctors. The company flooded medical journals with ads that featured good-looking people who radiated happiness, the ads touting Prozac as equal in efficacy to imipramine, and better tolerated. Science had proven that psychiatry had a new and much improved pill for depression, which appeared to correct a chemical imbalance in the brain.

The story that had been told in psychiatric journals was certain to resonate with the public. However, at this point, the market for antidepressants was still moderate in size. When Prozac was approved, Wall Street analysts predicted that it could generate $135 to $400 million in annual sales for Eli Lilly. But the drug companies, the APA, and the leaders of the NIMH were keen on expanding the market for antidepressants, and the NIMH’s DART “public awareness” campaign turned out to be the perfect vehicle for doing so.

After the NIMH announced its plans for DART in 1986, it had studied the public’s beliefs about depression. A survey revealed that only 12 percent of American adults would take a pill to treat it. Seventy-eight percent said they “would live with it until it passed,” confident they could handle it on their own. This was an attitude consistent with what the NIMH had preached only fifteen years earlier, when Dean Schuyler, head of the depressive section, had told the public that most depressive episodes “will run their course and terminate with virtually complete recovery without specific intervention.” There was epidemiological wisdom in the public’s belief that depression would pass, but the NIMH—once Shervert Frazier and other biological psychiatrists took the helm—was intent on delivering a different message.

The purpose of DART, the NIMH explained in 1988, was “to change public attitudes so that there is greater acceptance of depression as a disorder rather than a weakness.” The public needed to understand that it regularly went “underdiagnosed and under-treated,” and that it could “be a fatal disease” if left untreated. There were 31.4 million Americans who suffered from at least a mild form of depression, the NIMH said, and it was important that they get diagnosed. The public needed to be made aware that anti-depressants produced recovery rates of “70% to 80% in comparison with 20% to 40% for placebo.” The NIMH vowed to continue DART indefinitely in order to “inform” the public of these “facts.”
²⁷

The NIMH officially launched DART in May 1988, five months after Prozac landed on pharmacy shelves. The NIMH enlisted “labor, religious, educational groups” and businesses to help it spread its message, and of course pharmaceutical companies and NAMI had been on board from the start. The NIMH ran advertisements in the media, and Eli Lilly helped pay for the printing and distribution of 8 million DART brochures titled “Depression: What You Need to Know.” This pamphlet informed readers, among other things, of the particular merits of “serotonergic” drugs for the disease. “By making these materials on depressive illness available, accessible in physicians’ offices all over the country, important information is effectively reaching the public in settings which
encourage questions, discussion, treatment, or referral,” said NIMH director Lewis Judd.
²⁸

The remaking of the American mind was under way. This selling of depression, which was being done under the guise of a “public education” campaign, turned into one of the most effective marketing efforts ever devised. Newspapers picked up on this story, sales of Prozac began to soar, and then, on December 18, 1989, the green-and-white pill officially gained celebrity status when
New York
magazine put it on its cover.
BYE
,
BYE BLUES
, the headline screamed.
A NEW WONDER DRUG FOR DEPRESSION
. In the article, one “anonymous” user of Prozac said that on a scale of 1 to 100, he now felt “over 100.” Thanks to this new miracle pill, the magazine concluded, psychiatrists felt that their “profession has been buoyed.”
²⁹

Other such glowing stories quickly followed. On March 26, 1990,
Newsweek’
s cover featured the green-and-white capsule floating Nirvana-like over a beautiful landscape.
PROZAC: A BREAKTHROUGH DRUG FOR DEPRESSION
the magazine announced. Physicians were now writing 650,000 prescriptions for the pill each month, and “nearly everyone has something nice to say about the new treatment,”
Newsweek
said. Patients were loudly exclaiming, “I never felt better!”
³⁰
Three days later, Natalie Angier of the
New York Times
, who arguably was the nation’s most popular science writer, explained that antidepressants “work by restoring the balance of neurotransmitter activity in the brain, correcting an abnormal excess or inhibition of the electrochemical signals that control mood, thoughts, appetite, pain and other sensations.” This new drug, Dr. Francis Mondimore told Angier, “is not like alcohol or Valium. It’s like antibiotics.”
³¹
Television shows weighed in with a similar message, and on
60 Minutes
, Lesley Stahl told the inspiring story of a woman, Maria Romero, who, after a decade of horrible depression, had been reborn on Prozac. “Somebody, something left my body and another person came in,” Romero said. Stahl happily explained the biological cure that was at work: “Most doctors believe that chronic depression like Romero’s is caused by a chemical imbalance in the brain. To correct it, the doctor prescribed Prozac.”
³²

Fairly early on, there was a moment when this wonder-drug story threatened to fall apart. The problem, of course, was that fluoxetine did in fact stir suicidal and violent thoughts in some people, and during the summer of 1990, the issue of Prozac’s safety burst into the news. And it was then, at that critical moment, that Scientology proved so useful to Eli Lilly and the psychiatric establishment.

By 1990, so many people had suffered bad reactions to fluoxetine that a national Prozac Survivors Support Group had formed. Many harmed by the drug had taken their complaints to lawyers, and two lawsuits in particular grabbed the public’s attention. First, on July 18, newspapers reported that a Long Island woman, Rhoda Hala, was suing Eli Lilly because, after going on Prozac, she had slashed her wrists and “other parts of her body hundreds of times.”
³³
Two weeks later, newspapers reported on a lawsuit related to a mass murder committed by a crazed Kentucky man. Five weeks after starting the drug, Joseph Wesbecker walked into a Louisville printing plant where he had worked and opened fire with an AK-47 assault rifle, killing eight and wounding twelve. The Citizens Commission on Human Rights quickly issued a press release urging Congress to ban this “killer drug,” and that’s when Eli Lilly pounced. These lawsuits, Eli Lilly loudly announced, “are being drummed up by the Scientology group, which has a history of criticizing the use of psychiatric drugs.”
³⁴

This was the start of Eli Lilly’s campaign to save its blockbuster drug. “Lilly can go down the tubes if we lose Prozac,” wrote chief medical officer Leigh Thompson, in a harried 1990 memo.
³⁵
The company quickly honed a four-point message for the media: This was an issue being raised by Scientologists; extensive clinical trials had shown that Prozac was a safe drug; the suicidal and homicidal events were “in the disease, not the drug;” and “people who could be helped are being scared away from treatment, and that’s the real public menace.”
³⁶
The company ran media-training sessions for the academic psychiatrists it hired as consultants, getting them to practice their delivery of this message. “Frankly, I was unimpressed with
the performance of our outside professionals,” company vice-president Mitch Daniels complained to Thompson after one such practice session in April 1991. The company would “mandate” that the academic psychiatrists perform better “in their future training sessions,” he said.
³⁷

An article that appeared in the
Wall Street Journal
on April 19, 1991, showed that Eli Lilly’s training sessions had paid off. “Scientology,” the paper informed its readers, was a “quasi-religious/business/paramilitary organization” that was “waging war on psychiatry.” The group had attacked Prozac’s safety even though “doctors unaffiliated with Lilly” had found, during the clinical trials, that there was “a lower tendency toward suicidal thinking with Prozac than with other antidepressants, or with the starch capsules given to a control group.” It was, Leigh Thompson said, a “demoralizing revelation to watch twenty years of solid research by doctors and scientists shouted down in twenty-second sound bites by Scientologists and lawyers.” Indeed, the
Wall Street Journal
reported, Eli Lilly, in response to concerns about Prozac’s safety, had asked “suicide experts” to re-scrutinize the trial data, but they had “concluded that nothing in the clinical trials linked suicidal thinking—common in depression patients—to Prozac.” It was the disease, not the drug, and that was the tragedy, explained Jerrold Rosenbaum, a Harvard psychiatrist at Massachusetts General Hospital. “The public’s fear of Prozac as a result of this campaign has itself become a potentially serious public-health problem as people stay away from treatment.”
³⁸

Rosenbaum, naturally, was one of Eli Lilly’s “outside professionals.” As the
Boston Globe
later reported, he “sat on a marketing advisory panel for Lilly before Prozac was launched,” his relationship to Eli Lilly a “cozy” one.
³⁹
But the
Wall Street Journal
presented him as an independent expert, one of the nation’s top depression doctors, and so readers could only draw one conclusion: This was an issue conjured up by noxious Scientologists, rather than a legitimate concern. Other newspapers and magazines framed the issue in that way, with
Time
, in May of that year, publishing a scathing cover story on Scientology, calling it a “criminal organization” that attracted “psychopaths.”
⁴⁰

On September 20, 1991, the FDA did convene a hearing on whether Prozac elevated the risk of suicide, but the advisory panel, which was dominated by physicians with ties to pharmaceutical companies, showed little interest in seriously investigating this question. Although more than two dozen citizens testified on the harm that the drug could cause, the panel made sure that the scientific discussion was limited to presentations that supported Eli Lilly’s position that fluoxetine was perfectly safe. As the
Wall Street Journal
reported, the scientific data presented at the hearing proved that “fluoxetine doesn’t lead to increased suicide or suicidal thinking, and, in fact, show that the drug helps alleviate these conditions.” The entire controversy, one Lilly supporter told the
Journal
, was a “complete fiction” that had been “organized and funded by an anti-psychiatric group.”
⁴¹

At that moment, Eli Lilly and all of psychiatry had achieved a public relations victory of lasting importance. The wonder-drug aura around Prozac had been restored, and the public and the media had been conditioned to associate criticism of psychiatric drugs with Scientology. The debate over the merits of these drugs now seemed to feature the nation’s top scientists and doctors on one side and religious kooks on the other, and if that were so, the public could be certain where the truth lay. Other SSRIs came to market, sales of Prozac hit the $1 billion mark in 1992, and then, in 1993, Brown University psychiatrist Peter Kramer, in his book
Listening to Prozac
, pushed the wonder-drug story up a notch. Prozac, he wrote, was making some patients “better than well.” An era of “cosmetic psychopharmacology” was dawning, Kramer suggested, with psychiatry likely to have pills in the near future that could give normal people whatever personality they wanted. His book spent twenty-one weeks on the
New York Times
bestseller list, and soon
Newsweek
was warning readers that it was time for society to start grappling with the ethical questions raised by psychiatry’s new powers. “The same scientific insights into the brain that led to the development of Prozac are raising the prospect of nothing less than made-to-order, off-the-shelf personalities,”
Newsweek
explained in 1994. Will those who refuse to “give their brain a makeover,” the magazine asked, be left behind?