The Book of Woe: The DSM and the Unmaking of Psychiatry

by Gary Greenberg

  • • •

  Skeptics eventually raised questions about Biederman’s success. In 2006, Gardiner Harris reported27 on the front page of The New York Times that young children on drug cocktails—and often on government disability for their officially diagnosed Bipolar Disorder—were sometimes no better off than they had been before treatment, that their families were now torn apart not by their behavior but by the problems created by the drugs, that the kids were gaining weight and becoming suicidal. Most disturbing, Harris wrote, there was precious little scientific knowledge about this subject. This, coupled with stories such as that of Rebecca Riley28—a four-year-old girl who was diagnosed at age two and a half with Bipolar Disorder and prescribed a combination of an antipsychotic, an anticonvulsant, and an antihypertensive, and whose parents were arrested when she died after they gave her an overdose of the drugs—led to a disturbing conclusion: that no matter their intentions, doctors were conducting an experiment on children.

  In 2007, Charles Grassley, a Republican senator from Iowa, convened a series of hearings on the relationship between doctors and the pharmaceutical industry. “In psychiatry29,” The New York Times reported in 2008, “Mr. Grassley has found an orchard of low-hanging fruit.” Psychiatrists were the lowest-paid specialists in the country, with a median pay of just under $200,000—an income that you and I might find quite acceptable, but which paled next to the $464,420 earned by the average radiologist, and which, the Times insinuated, made the $750 to $3,500 speaking gigs offered by drug companies that much more attractive and the unseemliness of the business that much easier to gloss over. In Minnesota, psychiatrists who had taken $5,000 or more from antipsychotic manufacturers had written three times more antipsychotic prescriptions than unfunded doctors, and Vermont psychiatrists were receiving more drug company money than any other specialists in the state—an average of $56,944 each. A Cincinnati doctor reported $180,000 in income from AstraZeneca (makers of the antipsychotic Seroquel) over two years—bad enough, but, as Grassley discovered when he subpoenaed Astra’s records, the doctor had actually received $238,000, the unreported part funneled to her through a corporation the doctor had set up to hide the income.

  But this was all small beer compared with what Grassley found when he investigated Joseph Biederman30. Biederman and an associate had acknowledged a couple hundred thousand dollars in drug company income between 2000 and 2007, but Grassley, with the benefit of subpoena power, reckoned that it was more like $1.6 million, and that another associate had raked in at least another million. Much of this money was for the research that Biederman used to prove that BD existed in kids and that antipsychotics were the best treatment, but the Grassley committee found something out about that, too. Those studies not only were small and inconclusive—as research conducted by just one group of doctors tends to be—but also had one main patron: Johnson & Johnson, whose Janssen Pharmaceuticals makes risperidone (Risperdal), one of the antipsychotics often prescribed for bipolar kids.

  This shouldn’t have been a big surprise. The Johnson & Johnson Center for the Study of Pediatric Psychopathology was one of the affiliations Biederman listed among his credentials. But if Grassley had only discovered gambling in Casablanca, he had also revealed just how unsavory that business was and how much it favored the house. Biederman’s pitch to Johnson & Johnson for funding his center was that it would “move forward the commercial goals31” of the company, and when he succeeded at that, he sold his patrons a research project on the promise that it “will support the safety and effectiveness of risperidone32 in this age group”—something a scientist shouldn’t say out loud, even if he thinks it’s true, and something he definitely shouldn’t write in an e-mail that an ambitious senator might get hold of.

  On the other hand, most scientists wouldn’t testify in a sworn deposition as Biederman did in this exchange, which followed his testimony33 that he was a full professor at Harvard:

  Lawyer: What’s after that?

  Biederman: God.

  Lawyer: Did you say God?

  Biederman: Yeah.

  Divine or not, Biederman didn’t always get what he wanted. The company turned down his request for $280,000 to fund a study, and it balked at paying him $3,000 for a talk at a medical school. But, as a marketing executive pointed out in a plea on Biederman’s behalf, it wasn’t such a good idea to poke the bipolar bear. “I have never seen someone so angry34,” he e-mailed his superiors, describing Biederman’s reaction to being denied the research grant. “Since that time, our business became non-existant [sic] in his area of control.” Should Johnson & Johnson not cough up the three grand, the hapless marketer warned, “I am truly afraid of the consequences.” There were, after all, plenty of other makers of equally unproven antipsychotics ready to cozy up to this key opinion leader. (Biederman, who denied any quid pro quo in his arrangement with Johnson & Johnson, was sanctioned in 2011 for having “violated certain requirements35” of the university’s policies. The university forbade him to engage in industry-sponsored activities for one year, required him to get approval for outside work for the two years immediately following the ban, and imposed a “delay of consideration for promotion or advancement.” It did not say how long his elevation to God would have to wait.)

  Grassley wasn’t stopping with Biederman36. He went after Charles Nemeroff, head of the department of psychiatry at Emory University and the beneficiary of more than $2.8 million in drug money over seven years, nearly half of which had gone unreported to the university—a violation of federal law. He revealed that Frederick Goodwin37, the psychiatrist who hosted The Infinite Mind, an NPR program, had taken money from drug companies on the same day he reported that mood stabilizers were safe and effective treatments for pediatric Bipolar Disorder. (Goodwin responded to Harris in a lengthy note on his website pointing out that he had never concealed his drug company ties and that in his talks to psychiatrists he had discussed lithium, a drug that has been “generic for decades38 and doesn’t make enough money to justify promotion by drug companies.”) And Harris reported that Stanford psychiatrist Alan Schatzberg owned nearly $5 million in stock39 in a drug development company—which might not have raised an eyebrow but for one thing: Schatzberg was slated to become the president of the American Psychiatric Association in May 2009.

  Grassley was beginning to set his sights on the guild to which all these doctors belonged. On July 10, 2008, Jay Scully, the APA’s CEO, received a letter from Grassley on United States Senate letterhead. The senator had read the stories in The New York Times, he wrote, and he was not amused.

  I have come to understand40 that money from the pharmaceutical industry can shape the practices of nonprofit organizations which purport to be independent in their viewpoints and actions. Specifically, it is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products.

  Grassley ordered the APA to disclose how much of its income was drug money. The answer turned out to be a lot—according to the Times, nearly one-third of the organization’s $62.5 million annual revenue41 in 2006. Some of it came from advertising, but much of it went to educational programs in which drug companies tutored doctors attending APA conferences in the fine points of prescribing their drugs. The problem wasn’t a few rogue psychiatrists who had somehow risen to the top of their field. It was woven deeply into the fabric of the profession. It would have been nearly impossible to justify prescribing antipsychotics sold by any manufacturer to four-year-olds without the BD diagnosis. And the diagnosis would have been impossible without a DSM that Biederman could exploit. As the Times had reported earlier42, the DSM was not immune to industry influence. The paper cited the report of a team led by psychologist Lisa Cosgrove43, which calculated that 56 percent of the doctors who made up the work groups that produced the DSM-IV had financial ties to Big Pharma. Every member of the groups recommending changes for mood disorders and psychotic disorder
s had received drug money; and, as Cosgrove pointed out, “Pharmaceutical companies have a vested interest44 in what mental disorders are included in the DSM.”

  Of course, the drug industry has a vested interest in disease in general, and it has not restricted its creativity to psychiatry. Restless legs syndrome45, for instance, a disease invented as an alternative indication for GlaxoSmithKline’s underperforming anti-Parkinson’s drug Requip, can’t be blamed on the DSM. But there is no other field quite so susceptible to diagnostic exuberance as psychiatry. While many diagnoses are made on clinical signs and symptoms rather than on lab tests or other external validators, only in psychiatry are all diagnoses made that way. Psychiatry may have been low-hanging fruit for Grassley, but it was even riper picking for the pharmaceutical industry.

  • • •

  “With every new revelation46, our credibility with patients has been damaged, and we have to protect that first and foremost,” former APA president Steven Sharfstein told The New York Times in the aftermath of the Grassley investigation. “The price we pay for these kinds of revelations is credibility,” E. Fuller Torrey, one of the country’s most influential psychiatrists, chimed in, “and we just can’t afford to lose any more of that in this field.” These doctors probably didn’t know just how closely they were echoing the lament of Thomas Salmon. It was as if nothing had changed in a century. And, indeed, in a crucial way nothing had.

  That may be part of the reason that the APA decided that it was time for a radical DSM revision, that even if the paradigm had not really shifted, they couldn’t afford to stick with the tried and untrue. Michael First attempted to stop them. He figured he had the juice to criticize the APA’s reformist ambitions and still be tapped to head up the new effort. “I thought they would need my skills, so I pushed,” he told me.

  But he soon realized he had miscalculated. “I stood my ground, but it was becoming more and more clear that I was getting iced out.” And in April 2006, when he heard that the APA had appointed University of Pittsburgh psychiatry professor David Kupfer as chair of the task force and Darrel Regier as the vice chair, he was not surprised.

  Even five years later I could still hear disappointment in his voice when he told me, after a long pause, about hearing the bad news. He sounded a little bitter as he recounted the DSM-5 leadership’s failure to respond to his offer to repeat his stint as text editor, and its refusal to take his ideas seriously, but no more than you might expect from a guy who has seen the opportunity to do what he was born to do snatched away by people who he thought had the wrong idea of how to go about it.

  In the meantime, the task force’s attempts to get the revision under way were hampered by the shadow of corruption that was passing over the profession. In The Truth About the Drug Companies, author and former editor of The New England Journal of Medicine Marcia Angell had drawn attention to the unsavory relationship between the industry and the profession. And with a series of articles in prominent journals, she made it clear that the problem was not a figment of sensationalist journalists’ imaginations.

  Many psychiatrists thought the case against them was overblown. They insisted that drug company money did not influence their prescribing habits or, when it came to the DSM, their deliberations about what would get into the book. They also pointed out that the $4 million or so the industry kicked down every year47 for the APA’s “educational programs” amounted to free money for the organization and its members, providing training that ultimately benefited their patients. But, said Scully, “my board thought that through48 and instructed me to phase out those programs,” deciding, he told me, that “public trust was more important than money.”

  The board of trustees also decided to purge the DSM-5 of drug money. Task force and work group members would be able to hold no more than $50,000 in drug company stock and had to limit their earnings from the industry to $10,000 annually as long as they served. The trustees didn’t say how they had established those criteria for diagnosing corruption. Nor did they seem to have wondered whether this move was really the best solution to the Pharma infestation. After all, the corruption wasn’t so much financial as intellectual, the whole psychiatric-industrial consort dancing together to mutual satisfaction. The drug companies didn’t have to pay off psychiatrists to create particular diseases, not when whatever disorder found its way into the DSM could be exploited as an indication for a drug; who needs conspiracies when you have capitalism?

  For their part, psychiatrists didn’t have to be on the take to be eager to turn all the troubles their patients faced into nails for their chemical sledgehammers; they only had to want to give patients relief. And they surely didn’t have to be seduced into the medical model at lavish lunches, not when from their first days in medical school they had been, as Freud put it, “flirting with endocrinology and the autonomous nervous system.” But then again, while the trustees may have been more worried about public trust than money, they surely were still worried about money, which would continue to flow only so long as the public was convinced that psychiatrists were practicing real medicine.

  The trustees also underestimated the difficulty they would have in rounding up psychiatrists willing to take vows of relative poverty in order to spend years arguing over diagnostic criteria. Between those requirements and some others—that no university have more than two members on the same committee, for instance, and that efforts be made to recruit members from professions other than psychiatry and from outside the U.S.—it took nearly two years49 from the time Kupfer and Regier were named to the time the eighteen-member task force was assembled and appointed the 140 or so experts to the work group. So even as they announced their roster in May 2008, they had to know that their deadline—May 2012, which meant that they’d have to have a draft ready by the end of 2011—already loomed impossibly near.

  Michael First was not appointed to the task force. He was not placed on any of the work groups. He was not assigned to consult with the two work groups that requested him as an expert adviser. In 2007, the APA terminated the contract under which he had been the in-house DSM expert, representing the organization around the world. He was not alone in being left out in the cold. “All the people at the top50 of the previous DSMs were completely excluded,” he said. “There was some idea that the old forces would impede the paradigm shift, stand in the way of a new vision.”

  But the new forces were already losing confidence in that vision, or at least hedging their bets. Setting out the guidelines for making changes, the task force still asserted that “a new diagnostic paradigm must be developed51,” but it also cautioned that the DSM-5 would “not in itself represent a ‘paradigm shift.’” It vowed to maintain continuity with past editions, but it also promised that “unlike in DSM-IV, there will be no a priori constraints on the degree of change between DSM-IV and DSM-V.”

  The new book, it seemed, would be a departure, but then again, maybe it wouldn’t. The APA wasn’t going to constrain itself, nor would it commit itself to change. Instead, it would try to have it both ways.

  Chapter 6

  One of Allen Frances’s heroes is Cincinnatus, the Roman dictator who, drafted out of retirement to lead the army, slaughtered the enemy and promptly abdicated to return to his beloved farm. In Frances’s version of the story, by the time the DSM-5 effort got under way, he had lost interest in nosology.

  “I was bored stiff1 with the subject,” he told me. “I was pursuing another of my life’s goals—being a beach bum.”

  That was not the immediate purpose of his retirement from Duke in 1997, ten years earlier than he had planned. And it wasn’t boredom that drove him out. “Psychiatric classification2 may be the only boring topic in psychiatry,” he said. “Seeing patients and teaching never got boring,” and Duke offered plenty of opportunities to do that, as well as to travel the world giving talks, to conduct research, to add to his seventy-plus-page CV, to collect awards and fellowships, and,
if he’d been so inclined, to burnish his reputation as the most powerful psychiatrist in America. Rather, it was a personal matter: his wife Vera’s Parkinson’s disease was getting so bad that she needed his full-time care.

  According to the doctors, Vera wasn’t even supposed to be alive by then. She had been diagnosed in 1988 with brain cancer and given a year to live. “Perhaps not surprisingly, the diagnosis3 was unreliable and imprecise,” Frances said. “And the prognosis was simply wrong.”

  In the end it wasn’t the cancer that took her life. It was the treatment, which had caused her Parkinson’s. After it worsened in 1997, they moved, first back to New York, where he had spent the first twenty-five years of his career at Cornell and Columbia (where he worked with Bob Spitzer), and then to San Diego. When planning for the DSM-5 started in 1998, he was nursing Vera, sitting on the beach, reading history, and spending time with his grandchildren, who lived nearby. After Vera died in 2007, he remained uninvolved. But then in 2009 a colleague told him about a proposal for what Frances thought was an unreliable and imprecise diagnosis with a questionable prognosis and a dangerous treatment—so dangerous, in fact, that it got Allen Frances off the beach and into the fight of his professional life.