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Psychiatry's Diagnostic Manual Under Drug Industry Influence Print E-mail
Thursday, 20 April 2006

The undisclosed financial relationships between drug manufacturers and psychiatry's leading "authorities" who determine what constitutes a “mental disorder” have been exposed.

The DSM is psychiatry’s official authoritative diagnostic manual published by the American Psychiatric Association. The significant findings of Lisa Cosgrove and Sheldon Krimsky (the two lead authors), confirm that the psychiatrists who formulate psychiatry’s diagnostic “bible”—which has ballooned from a list of 107 mental health disorders in 1952, to 365 in 1994, DSM-IV—have been caught with their hands in the cookie jar.  To borrow the title of a book by Dr. Jerome Kassirer), psychiatry’s most influential leaders are "On the Take."  

"One hundred percent of the members of the panels on “Mood Disorders” and “Schizophrenia and other Psychotic Disorders” had financial ties to drug companies."

From the tepid report on page 20 of the New York Times, one would never guess the magnitude of the financial stakes involved:

"These are the categories of mental illness where most of the drugs are prescribed. Antidepressants were the 4th and leading class of drugs in 2004 with annual global sales totaling $20.3 billion. And antipsychotics, the 5th leading class, annual sales total  $14.1 billion--and are projected to increase to  $18.2 billion by 2007."

Those sales bear a direct relationship to the way the DSM is “crafted”:
Commenting from the UK, Dr. David Healy, a foremost expert in psychopharmacology, who has been highly critical of industry’s influence on the treatment of patients, notes that the conditions that do not respond to the preferred drugs were dropped from the DSM:

“In the case of schizophrenia for instance in a recent edition of the DSM the panel got rid of the hebephrenia subtype - the interesting thing about
this is that hebephrenia responds poorly to antipsychotics.  Getting rid of it leads clinicians to think all forms of schizophrenia are likely to
respond to antipsychotics when this is not the case.

In the case of mood disorders, previous panels have got rid of melancholia or endogenous depression in favor of major depressive disorder, and the
interest here is that older pre-SSRI antidepressants are much better at treating these severe forms of depression than SSRIs are.“

The Chicago Tribune reports that other critics also recognize the threat to the integrity of science:  “The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry," said Dr. Irwin Savodnik, an assistant clinical professor of psychiatry at the University of California.

Of note, the methodology used by authors understates the panelists' financial remunerations from drug companies because they limited those ties to DIRECT payments.
"Panel members were screened for any financial affiliations they had with the drug industry between the years 1989 (the DSM-IV was published in 1994) through 2004. By using multiple screening techniques to gather published or Internet data on financial affiliations, we were able to avoid a methodology that relied solely on self-reporting (e.g., surveying panel members).  Financial associations of interest for this study include: honoraria, equity holdings in a drug company; principal in a startup company, member of a scientific advisory board or speakers bureau of a drug company; expert witness for a company in litigation; patent or copyright holder; consultancy; gifts from drug companies including travel, grants, contracts, and research materials. We use the term ‘financial interest’ in describing the relationship between panel members and the pharmaceutical industry rather than the term ‘conflict of interest’ (COI) because the latter term implies an interpretation of the interest. Thus, we choose not to define COI. Rather, we identify categories of financial interest and reserve judgment on whether they represent a real, perceived, or potential COI."
[See: Financial Ties between DSM-IV Panel Members and the Pharmaceutical Industry, in Psychotherapy & Psychometrics, 2006, 75:154-160 ]

"The leading categories of financial interest held by panel members were Research funding (42%), Consultancies (22%) and Speaker’s Bureau (16%).”

The study did not include money, such as honoraria, paid through universities that received grants from drug companies for professional conferences, symposia, grand rounds, and other university-sponsored / industry funded "educational" activities. Taxpayers have a right to know if tax exempt universities funnel pharmaceutical company money to academics. Whether funds are paid directly to academics, or through the university, the money compromises the integrity of science, the integrity of professional judgment.

The finding that most of the money received by the DSM -IV panelists was for research, underscores the reason why most of psychiatry's reports about drug efficacy and safety have turned out to be dubious. See findings of the NIMH recent STAR and CATIE studies which overturn previous reports about the efficacy of antidepressants and  antipsychotics. [See: http://www.ahrp.org/cms/index.php?searchword=catie&option=com_search&Itemid=5

  Within a day or two we will examine the ‘head in the sand’ press reports that avoided questions challenging the professional legitimacy of psychiatry.
 
Contact: Vera Hassner Sharav
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http://www.chicagotribune.com/news/nationworld/chi-0604200194apr20,1,3690657.story?

Chicago Tribune
Top mental health guide questioned
By Judith Graham

Published April 20, 2006

Most of the experts who prepared the world's leading medical guide to mental illness had undisclosed financial relationships with drug companies that presented potential conflicts of interest, according to a new report published Thursday in the journal Psychotherapy and Psychosomatics.

The study is the first to document extensive monetary connections between drug companies, psychiatrists and other scientists responsible for the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

The DSM, as it's commonly called, defines all the mental illnesses recognized by psychiatry and outlines the criteria used to determine whether a person has one of these conditions. Medical professionals refer to it as the "bible of mental health" in the U.S. The current version, the DSM-IV, was published in 1994 and modified in 2000.

The manual is of enormous importance to pharmaceutical firms, as the Food and Drug Administration will not approve a drug to treat a mental illness unless the condition is in the DSM. Drug companies then can market approved medications to physicians and consumers.

"This is one of the most important medical documents we have in this country, yet the public doesn't have relevant information about the experts involved in developing and revising it," said Sheldon Krimsky, a Tufts University professor and co-author of the new paper. His study found that 56 percent of 170 panel members responsible for overseeing the DSM-IV had some type of financial tie to the drug industry--including getting research grants from drug companies (42 percent), serving as consultants (22 percent) and participating in speakers bureaus (16 percent). These relationships weren't revealed publicly.

The risk is that financial relationships might directly or indirectly bias panel members to make decisions favorable to the drug industry. Relationships formed after the DSM-IV's publication also can be problematic in that panel members could appear to be "cashing in" on their influence, Krimsky noted. The enormous growth in prescriptions for psychiatric drugs also raises concerns about the potential impact on consumers.

Dr. Darrel Regier, director of research at the American Psychiatric Association, said disclosure of potential conflicts of interest "wasn't the standard in the field" at the time the latest edition came out. "For the next revision," due in 2011, "we will have full disclosure," he said.

Of particular concern, Krimsky suggested, is his study's finding that 100 percent of the experts on DSM-IV panels overseeing mood disorders and schizophrenia / psychotic disorders were financially involved with the drug industry. These are the largest categories of psychiatric drugs in the world--2004 sales of $20.3 billion and $14.4 billion respectively.

"The more lucrative the drug market, the higher the percentage of experts with financial ties--that has to raise serious questions about these panels' objectivity," said David Rothman, professor of social medicine at Columbia University's College of Physicians and Surgeons.

"We have not had an opportunity to review the study, but it is important to note that the physicians and other health-care professionals who sat on expert medical advisory panels have impeccable integrity," said Ken Johnson, senior vice president for Pharmaceutical Research and Manufacturers of America.

Others think drug industry practices are challenging the integrity of science. "The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry," said Dr. Irwin Savodnik, an assistant clinical professor of psychiatry at the University of California, Los Angeles. According to his calculations, the original 1952 DSM manual contained 107 mental health disorders. By the fourth edition in 1994, the number had more than tripled to 365.

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Copyright © 2006, Chicago Tribune
~~~~~~~~~~~~~~~~
 
THE NEW YORK TIMES
 April 20, 2006
Study Finds a Link of Drug Makers to Psychiatrists
By BENEDICT CAREY

More than half the psychiatrists who took part in developing a widely used diagnostic manual for mental disorders had financial ties to drug companies before or after the manual was published, public health researchers reported yesterday.

The researchers found that 95 — or 56 percent — of 170 experts who worked on the 1994 edition of the manual, called the Diagnostic and Statistical Manual, or D.S.M, had at least one monetary relationship with a drug maker in the years from 1989 to 2004. The most frequent tie involved money for research, according to the study, an analysis of financial records and conflict-of-interest statements.

The percentage was higher — 100 percent in some cases — for experts who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia, the study found. But the authors, from Tufts University and the University of Massachusetts, were not able to establish how many of the psychiatrists were receiving money from drug companies while the manual was being compiled.

Lisa Cosgrove, the study's lead author, who is a psychologist at the University of Massachusetts in Boston, said that although the study could not prove that the psychiatrists' ties influenced the manual's development, "what we're saying is it's outrageous that the manual doesn't have a disclosure policy."

But other experts scoffed at the idea that commercial interests had influenced either the language or content of the manual. "I can categorically say, and I was there every step of the way, that drug-company influence never entered into any of the discussions, whatsoever," said Dr. Michael First, a psychiatry professor at Columbia, who coordinated development of the current D.S.M.

Some 400,000 mental health workers, from psychiatrists to nurses, use the manual to diagnose disorders in patients, and health insurers use the manual to determine coverage.

In recent years, critics have said that the manual has become too expansive, including diagnoses, like social phobia, that they say appear tailor-made to create a market for antidepressants or other drugs.

The study investigated the financial ties by sifting through legal files, patent records, conflict-of-interest databases and journal articles, among other records.

Twenty-two percent of the experts received consulting income in the years from 1989 to 2004, the study found, and 16 percent served as members of a drug maker's speakers bureau. Such services are typically more lucrative than research support.

Copyright 2006 The New York Times Company



http://www.usatoday.com/printedition/news/20060420/a_conflicts20.art.htm
USA TODAY  Page 6A
Study: Medical manual's authors often tied to drugmakers
By Dan Vergano

A majority of the medical experts who created the “bible” for diagnosing mental illness have undisclosed financial links to drugmakers, says a study out today.

And some panels overseeing disorders that require treatment with prescription drugs, such as schizophrenia and “mood disorders,” were 100% filled with experts financially tied to the pharmaceutical industry, says the study published in the journal Psychotherapy and Psychosomatics.

The Diagnostic and Statistical Manual for Mental Disorders (DSM) is the American Psychiatric Association's diagnosis manual. It is also used as the basis for insurance payments for psychiatric treatments, including drugs.

“No blood tests exist for the disorders in the DSM. It relies on judgments from practitioners who rely on the manual,” says lead study author Lisa Cosgrove of the University of Massachusetts Boston.

The researchers looked for research funds, consultancies, patents and other gifts or grants received by members of the 18 separate DSM preparation panels from 1989 to 2004, both before and after their terms.

They found that among the 170 medical experts who created the two most recent editions of the manual, 56% had one or more financial ties to the pharmaceutical industry. In addition to the schizophrenia and mood disorder panels' links, more than 80% of panel members for “anxiety disorders,” “eating disorders,” “medication-induced movement disorders” and “premenstrual dysphonic disorder” had financial ties.

“Psychiatrists rely on the APA (American Psychiatric Association) to police its activities, and we take that responsibility very seriously,” association psychiatrist Darrel Regier says. The next edition, scheduled for release in 2011, will disclose all industry financial ties to panel members, he says, either in the manual or on a website.

“I don't think that's good enough. People don't poke around in the latest issue looking for conflict-of-interest statements,” says physician Peter Lurie of Public Citizen, a consumer advocacy group based in Washington, D.C. Ideally, the DSM would be created by experts without any financial links to drugmakers, he says.

The Pharmaceutical Manufacturers Association responded, in a statement by spokesman Ken Johnson, that the health care professionals on these panels “have impeccable integrity and base their decisions on independent judgments and research.”

This month, the journal PLOS Medicine accused the drug industry of “disease-mongering,” inventing diseases from everyday aggravations, such “restless legs syndrome,” and widening definitions to sweep up more patients.

Psychologist David Healy of the United Kingdom's Cardiff University notes that recent revisions to the DSM eliminated a subtype of schizophrenia that responded poorly to drugs. And “melancholia” was eliminated in favor of major depressive disorder, Healy says. “The upshot is that some patients are going to lose out,” he says.

Regier disputes the claims.

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