New York Review of Books – From the July 14, 2011 issue
by Marcia Angell

United Artists/Photofest Lan Fendors, Louise Fletcher, and Jack Nicholson in One Flew Over the Cuckoo's Nest, 1975
In my article in the last issue, I focused mainly on the recent books by psychologist Irving Kirsch and journalist Robert Whitaker, and what they tell us about the epidemic of mental illness and the drugs used to treat it.1 Here I discuss the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM)—often referred to as the bible of psychiatry, and now heading for its fifth edition—and its extraordinary influence within American society. I also examine Unhinged, the recent book by Daniel Carlat, a psychiatrist, who provides a disillusioned insider’s view of the psychiatric profession. And I discuss the widespread use of psychoactive drugs in children, and the baleful influence of the pharmaceutical industry on the practice of psychiatry.
One of the leaders of modern psychiatry, Leon Eisenberg, a professor at Johns Hopkins and then Harvard Medical School, who was among the first to study the effects of stimulants on attention deficit disorder in children, wrote that American psychiatry in the late twentieth century moved from a state of “brainlessness” to one of “mindlessness.”2 By that he meant that before psychoactive drugs (drugs that affect the mental state) were introduced, the profession had little interest in neurotransmitters or any other aspect of the physical brain. Instead, it subscribed to the Freudian view that mental illness had its roots in unconscious conflicts, usually originating in childhood, that affected the mind as though it were separate from the brain.
But with the introduction of psychoactive drugs in the 1950s, and sharply accelerating in the 1980s, the focus shifted to the brain. Psychiatrists began to refer to themselves as psychopharmacologists, and they had less and less interest in exploring the life stories of their patients. Their main concern was to eliminate or reduce symptoms by treating sufferers with drugs that would alter brain function. An early advocate of this biological model of mental illness, Eisenberg in his later years became an outspoken critic of what he saw as the indiscriminate use of psychoactive drugs, driven largely by the machinations of the pharmaceutical industry.
When psychoactive drugs were first introduced, there was a brief period of optimism in the psychiatric profession, but by the 1970s, optimism gave way to a sense of threat. Serious side effects of the drugs were becoming apparent, and an antipsychiatry movement had taken root, as exemplified by the writings of Thomas Szasz and the movie One Flew Over the Cuckoo’s Nest. There was also growing competition for patients from psychologists and social workers. In addition, psychiatrists were plagued by internal divisions: some embraced the new biological model, some still clung to the Freudian model, and a few saw mental illness as an essentially sane response to an insane world. Moreover, within the larger medical profession, psychiatrists were regarded as something like poor relations; even with their new drugs, they were seen as less scientific than other specialists, and their income was generally lower.
In the late 1970s, the psychiatric profession struck back—hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.
These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”
When Spitzer’s DSM-III was published in 1980, it contained 265 diagnoses (up from 182 in the previous edition), and it came into nearly universal use, not only by psychiatrists, but by insurance companies, hospitals, courts, prisons, schools, researchers, government agencies, and the rest of the medical profession. Its main goal was to bring consistency (usually referred to as “reliability”) to psychiatric diagnosis, that is, to ensure that psychiatrists who saw the same patient would agree on the diagnosis. To do that, each diagnosis was defined by a list of symptoms, with numerical thresholds. For example, having at least five of nine particular symptoms got you a full-fledged diagnosis of a major depressive episode within the broad category of “mood disorders.” But there was another goal—to justify the use of psychoactive drugs. The president of the APA last year, Carol Bernstein, in effect acknowledged that. “It became necessary in the 1970s,” she wrote, “to facilitate diagnostic agreement among clinicians, scientists, and regulatory authorities given the need to match patients with newly emerging pharmacologic treatments.”3
The DSM-III was almost certainly more “reliable” than the earlier versions, but reliability is not the same thing as validity. Reliability, as I have noted, is used to mean consistency; validity refers to correctness or soundness. If nearly all physicians agreed that freckles were a sign of cancer, the diagnosis would be “reliable,” but not valid. The problem with the DSM is that in all of its editions, it has simply reflected the opinions of its writers, and in the case of the DSM-III mainly of Spitzer himself, who has been justly called one of the most influential psychiatrists of the twentieth century.4 In his words, he “picked everybody that [he] was comfortable with” to serve with him on the fifteen-member task force, and there were complaints that he called too few meetings and generally ran the process in a haphazard but high-handed manner. Spitzer said in a 1989 interview, “I could just get my way by sweet talking and whatnot.” In a 1984 article entitled “The Disadvantages of DSM-III Outweigh Its Advantages,” George Vaillant, a professor of psychiatry at Harvard Medical School, wrote that the DSM-III represented “a bold series of choices based on guess, taste, prejudice, and hope,” which seems to be a fair description.
Not only did the DSM become the bible of psychiatry, but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions. That is an astonishing omission, because in all medical publications, whether journal articles or textbooks, statements of fact are supposed to be supported by citations of published scientific studies. (There are four separate “sourcebooks” for the current edition of the DSM that present the rationale for some decisions, along with references, but that is not the same thing as specific references.) It may be of much interest for a group of experts to get together and offer their opinions, but unless these opinions can be buttressed by evidence, they do not warrant the extraordinary deference shown to the DSM. The DSM-III was supplanted by the DSM-III-R in 1987, the DSM-IV in 1994, and the current version, the DSM-IV-TR (text revised) in 2000, which contains 365 diagnoses. “With each subsequent edition,” writes Daniel Carlat in his absorbing book, “the number of diagnostic categories multiplied, and the books became larger and more expensive. Each became a best seller for the APA, and DSM is now one of the major sources of income for the organization.” The DSM-IV sold over a million copies.
As psychiatry became a drug-intensive specialty, the pharmaceutical industry was quick to see the advantages of forming an alliance with the psychiatric profession. Drug companies began to lavish attention and largesse on psychiatrists, both individually and collectively, directly and indirectly. They showered gifts and free samples on practicing psychiatrists, hired them as consultants and speakers, bought them meals, helped pay for them to attend conferences, and supplied them with “educational” materials. When Minnesota and Vermont implemented “sunshine laws” that require drug companies to report all payments to doctors, psychiatrists were found to receive more money than physicians in any other specialty. The pharmaceutical industry also subsidizes meetings of the APA and other psychiatric conferences. About a fifth of APA funding now comes from drug companies.
Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.5
The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.
In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone,
Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.
And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:
In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.
Read the rest of the article here: http://www.nybooks.com/articles/archives/2011/jul/14/illusions-of-psychiatry/
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Why Drug Companies Are Shy About Sharing On Facebook
Tuesday, August 23rd, 2011NPR – August 22, 2011
by Nancy Shute
Drug firms fear that being "liked" on Facebook could get them in trouble with the FDA. iStock photo
People love how Facebooklets them comment on and share other people’s posts. But the idea of sharing on social media has got drug companies scared. When Facebook told drugmakers that they had to start allowing comments on their Facebook pages, some of those pages started disappearing.
“Take On Depression” suddenly disappeared. “ADHD Moms” vanished, too. So did “Epilepsy Advocate.” In the past, drug companies had been reluctant to create Facebook pages without a guarantee that they’d be closed to public comments — a unique accommodation on Facebook’s part. But that accommodation ended last week.
Diabetes blogger Amy Tenderichthinks it’s high time the drug companies quit walling themselves off. She’s the founder of Diabetest Mine, an independent site. She says: “The notion that they would be able to be able to put up these Facebook pages and then close them off to comments is ridiculous.”
On her site, people with diabetes comment a lot. They share information on what drugs they’re taking, give each other advices on dosages, and tell people which drugs are working for them, and which are causing side effects. For Tenderich and others, the whole point of social media like Facebook and Twitter is to comment on other people’s posts.
But drug companies have to play by different rules. The Food and Drug Administration requires that each a drug manufacturer mentions a prescription drug, they also have to list its risks and side effects. That’s called fair balance.
“You see some of those magazine ads that are three and four pages long and you wonder why they are?” asks Tony Jewell, who supervises drugmaker AstraZeneca’s social media efforts. “It’s because we’re communicating the full risks, benefits and appropriate use of the medicine. That’s a little bit harder to do in a social media channel like Facebook and Twitter.”
One big reason companies cite for killing Facebook pages is that they wouldn’t be able to adequately police comments with inaccurate information about prescription drugs.
“So they might say, ‘Lipitor’s great at whitening your teeth,’ which it’s not approved to do,” says Jonathan Richman. That’s his example of a potentially dicey comment. He’s a group director for the Possible Worldwide ad agency in Cincinnati, and he closely follows the drug industry’s social media efforts on his Dose of Digital blog. “The question becomes, What’s Pfizer’s liability? What action could the FDA take, based on somebody else posting that?”
So far, the FDA hasn’t come down on a single drug company for allowing public comments. The only action the agency has taken against use of social media was last year, when it warnedNovartis that a Facebook “share” widget for the leukemia drug Tasignaviolated fair balance.
But the FDA also hasn’t told the companies how to use social media and still follow the “fair balance” rule. In November 2009, the agency held public hearingson how pharma companies should use social media. But the FDA has yet to issue official guidance. Jewell says that because of that, his employer and other companies are erring on the side of caution.
Tenderich says patients would benefit from a rich interaction with drug makers. She sees more and more drug company employees interacting on her site, giving advice on behalf of their employers. That’s a huge benefit for patients, she says.
The pharmaceutical companies could benefit, too, she says, by learning what problems patients are having with drugs, and how to make them better.
“They could get so much fantastic, free, very high-value feedback,” she says.
http://www.npr.org/blogs/health/2011/08/22/139859210/why-drug-companies-are-shy-about-sharing-on-facebook?ps=sh_sthdl
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Tags: ADHD Moms, comments, Drug companies, drugmakers, Facebook, FDA, Take on Depression
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