The Book of Woe: The DSM and the Unmaking of Psychiatry (11 page)

It was possible that the new diagnostic approach had uncovered a previously unknown epidemic. But as Duke University’s chief of child and adolescent psychiatry, John March, told
The New York Times
when the diagnostic increase was reported, “
The label may or may not reflect reality
¹⁹
.” No one questioned that there were many children whose explosiveness and irritability terrified their parents and defied treatment. But did they really have BD?

But March had it backward. The diagnostic label had been redesigned specifically to reflect reality, and reality had followed suit; those explosive children were now bipolar patients, and the sooner parents thought of them (and taught them to think of themselves) as afflicted with a chronic disease, the sooner they could get help. If Biederman had set out to become the Johnny Appleseed of an entirely new disorder—“scary impossible child disorder,” let’s say—rather than of a new version of an old illness, then the websites and self-help books and cover stories would be offering support for kids diagnosed with that disease, doctors would be arguing about whether or not it reflected reality, and parents would be wondering whether or not their kids warranted the SIC label.

But that’s not what Biederman did. Neither did he tinker with, say, ADHD or Oppositional-Defiant Disorder (ODD), or simply suggest that clinicians use a perfectly good DSM diagnosis—Disruptive Behavior Disorder, NOS (312.9) seems well suited—and be done with it. He wasn’t determined only to give these children a new diagnostic home. He also had a very specific idea about where they belonged, and if the evidence didn’t support his conviction, then he would change the rules by which the evidence was admitted.

It’s not clear why Biederman settled on Bipolar Disorder. But it’s easy enough to imagine the possible motives: to ensure that insurance companies would pay for the extensive treatment these kids needed, which a diagnosis of ADHD or ODD did not always justify, but BD does; to make his professional mark by changing one of psychiatry’s most venerable diagnoses; to confirm a hunch. But the label also reflected another reality: that, as Dr. Samuel tells Brandon,
there is “some medicine that could help
²⁰
you feel better.” Indeed, just as Biederman was starting to persuade his colleagues to be on the lookout for childhood mania, new treatments were coming to market to supplement the old standby, lithium. Drug makers were touting anticonvulsants such as Abbott Laboratories’ Depakote, and
rebranding
atypical antipsychotics
²¹
—Zyprexa, Seroquel, Abilify, and Risperdal—as
mood stabilizers
, the category to which lithium belonged and surely a less terrifying term.

These treatments were not without their problems. They are sedating—heavily so in the case of the antipsychotics—which means that it is hard to know if they were treating BD or just tranquilizing the children. They are also associated with
devastating side effects
²²
: cataracts, obesity, diabetes, tardive dyskinesia (a movement disorder characterized by tics and spasticity), which add up to a
twelve-to-twenty-year decrease in life expectancy
²³
for treated versus untreated patients. And even as the drug companies began to seek (and eventually receive) FDA approval to use the drugs as mood stabilizers and to rechristen them accordingly, they did not study their effectiveness (or their side effects) in children—largely because BD wasn’t thought to affect kids.

Biederman and others did run some
studies indicating that children’s symptoms improved
²⁴
in response to the mood stabilizers. But these were short-term trials, often eight weeks or less, and could not possibly explore the consequences for a developing brain of daily use of a powerful drug. Nor could the studies tease out the question of whether the results were due to the overall sedative effects of the drugs or to something specific to these patients. Neither did advocates of mood stabilizers for children talk very much about the obesity and resulting diabetes that were known side effects of the drugs. None of this ignorance put the brakes on the bipolar express, however. Diagnosis and treatment rates continued to soar—by 2003,
prevalence of BD among children
²⁵
had increased fortyfold over a decade and, hardly coincidentally, by 2005,
antipsychotic use in children and adolescents
²⁶
had grown by 73 percent in only four years. In 2007 alone, half a million children, twenty thousand of them under six years old, were prescribed drugs that a decade before would have been prescribed only in the most dire circumstances. Biederman’s diagnostic innovation was a runaway hit.

•   •   •

Skeptics eventually raised questions about Biederman’s success. In 2006,
Gardiner Harris reported
²⁷
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 Riley
²⁸
—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 psychiatry
²⁹
,”
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 Biederman
³⁰
. 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 goals
³¹
” 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 risperidone
³²
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 testimony
³³
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 angry
³⁴
,” 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 requirements
³⁵
” 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 Biederman
³⁶
. 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 Goodwin
³⁷
, 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 decades
³⁸
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 stock
³⁹
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 understand
⁴⁰
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 revenue
⁴¹
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 earlier
⁴²
, the DSM was not immune to industry influence. The paper cited
the report of a team led by psychologist Lisa Cosgrove
⁴³
, 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 disorders had received drug money; and, as Cosgrove pointed out, “
Pharmaceutical companies have a vested interest
⁴⁴
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 syndrome
⁴⁵
, 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.