Conflicts of interest: psychiatry’s diagnostic manual DSM-III_DSM-IV

This is part II relating to a study by Drs. Lisa Cosgrove (U of Mass) and Sheldon Krimsky (Tuffts) who provide empirical evidence documenting a major breech of professional ethics.
The American Psychiatric Association’s DSM-IV “expert” panelists, whose judgement alone–absent empirical evidence–determines how mental disorders are defined, diagnosed, and treated, are shown to have financial ties to drug manufacturers.

Dr. Krimsky points out that psychiatry fails to meet basic standards of professional objectivity: "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."

The Washington Post reports that APA president Dr. Steven Sharfstein expressed concern last year about the profession: "As a profession, we have allowed the biopsychosocial model to become the bio-bio-bio model.”  He then said, "If we are seen as mere pill pushers and employees of the pharmaceutical industry, our credibility as a profession is compromised."

To gain insight into how DSM workgroups have operated under the influence of drug manufacturers, check out the 1984 memoranda from Dr. Robert Spitzer, chairman of the APA Workgroup to revise DSM-III, laying plans for a workgroup meeting (October 4-5, 1984). Specifically, the documents reveal that diagnostic criteria linking panic disorder and agoraphobia were “created” jointly by the APA and Upjohn’s Psychopharmacology Division, to meet Upjohn Company specifications “for its [drug] study.”   Final disposition: "The consensus favored Upjohn…"   See: http://ahrp.org/COI/UpjohnDSM.ppt

Dr. Spitzer is quoted in Bloomberg News, stating: “If you’re an expert in schizophrenia, you’re almost certainly going to be asked to either consult or give a talk which is paid for. But what’s the conflict?”  Perhaps this demonstrates that drug manufacturers’ control over the DSM continues unabated since the 1980s.

The indignant, self-righteous protestations by psychiatry’s research leadership to the Cosgrove / Krimsky study, as reported by The Washington Post, Bloomberg News, and the NJ Star Journal, are about as convincing as those heard at a house of ill repute during a police raid.

Dr. Nancy Andreasen, who heads the schizophrenia DSM IV panel, called the new analysis "very flawed" “because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward.”

Dr. John Kane, another schizophrenia panelist said: "It shouldn’t be assumed there is a true conflict of interest. The panel’s conclusions were driven only by science.” "To me, a conflict of interest implies that someone’s judgment is going to be influenced by this relationship, and that is not necessarily the case. . . ."

Unfortunately, empirical evidence is something psychiatry sorely lacks as a profession: neither psychiatry’s 365 diagnoses nor the recommended treatments in the DSM are backed by scientific evidence.

The pharmaceutical industry is not known for its beneficence; nor do drug companies shell out money with “no strings” attached.  The financial largesse to psychiatry’s opinion leaders has proven to be an exceptionally profitable investment. If antidepressant and antipsychotic sales figures are any indication–$34 billion and $14 billion respectively—then the experts  on DSM–IV schizophrenia and mood disorder panels delivered.  Indeed, they have lent legitimacy to the unprecedented diagnosing of millions of American children with mental disorders  for which they are prescribed these highly toxic drugs off-label. Even toddlers are unsafe from being exposed to prescribed mind altering drugs.

The most vituperative response to the conflict of interest revelations comes from APA’s director of research, Dr. Darrel Regier, who said the study was "an attempt to develop probably some guilt by association with the pharmaceutical industry." He said he did not believe financial connections to companies influenced development of the manual.  He criticized the study as a “non-scientific paper in a very obscure journal,” and said the authors were part of a political campaign “to discredit the existence of mental disorders.”

The empirical evidence documented by Cosgrove and Krimsky may ultimately shake loose psychiatry’s stranglehold on the psychological-behavioral professions that have (until now) assumed that the diagnosis and treatment recommended in the DSM-IV were arrived at objectively.

*Part I, see:  http://www.ahrp.org/cms/content/view/143/27/

Contact: Vera Hassner Sharav
veracare@ahrp.org

http://www.sltrib.com/business/ci_3733253
BLOOMBERG NEWS
Psychiatric Manual’s Authors Have Financial Ties to Drugmakers
2006-04-20 15:29 (New York)
By Rob Waters

     April 20 (Bloomberg) — Most of the psychiatrists who helped write a standard manual that guides the diagnosis and treatment of mental disorders have financial ties to the pharmaceutical industry, a study found.

     The manual, published by the American Psychiatric Association since 1952, lists mental disorders, outlines how to diagnose them and includes diagnostic codes that help determine how patients are treated, what medications should be used and whether insurance companies will pay for services.

     Decisions on the manual’s contents are made by panels of psychiatric experts, most of whom have financial links to drugmakers, the study found. Nearly half got research funding, 22 percent were consultants and 15 percent were on a speakers’ bureau. The survey raises question about the experts’ ability to put the interests of patients ahead of drug companies who provide them with funds, the investigators said.

     “When there are multiple financial associations of panel members to pharma companies, the risk is both the appearance of conflict of interest and the potential for those associations to influence decisions,” said researcher Lisa Cosgrove, an assistant professor of psychology at the University of Massachusetts in Boston, in a telephone interview yesterday.

     Cosgrove and Sheldon Krimsky, a researcher on science and ethics at Tufts University in Boston, checked databases and the financial disclosure notices authors append to scientific papers to screen links between drugmakers and 170 experts who worked on the most recent volume of the Diagnostic Statistical Manual, published in 1995.      The study is to be published tomorrow in the medical journal Psychotherapy and Psychosomatics.

                      `What’s the Conflict?’
     Robert Spitzer, a professor of psychiatry at Columbia University in New York who chaired the task force that created the 1980 edition of the manual, and acted as a consultant on subsequent volumes, said the financial links don’t necessarily open up ethical problems.

     “Of course these experts have a relationship” with drug companies, Spitzer said in a telephone interview today. “If you’re an expert in schizophrenia, you’re almost certainly going to be asked to either consult or give a talk which is paid for. But what’s the conflict?”

     Drug company funding of panel members “did not influence in any way” the decisions to create disorders or how to define them, he said. “Nobody says, `If we do this, it will make it easier for Pfizer to sell a drug,’ ” Spitzer said.

     Cosgrove said the subjective nature of psychiatric diagnosis — there are no blood or cholesterol tests for detecting depression — means that experts must rely on their own clinical judgment, which might be influenced by their financial ties.

                      `Non-Scientific Paper’
     Darrel Regier, director of the division of research for the American Psychiatric Association, which published the DSM, criticized the study as a “non-scientific paper in a very obscure journal,” and said the authors were part of a political campaign “to discredit the existence of mental disorders.”

     Regier said the next edition of the manual, to be published in 2011, will require all panel members to disclose their financial associations, a requirement increasingly imposed by medical journals. He said that was not the standard 15 years ago when the last edition was being prepared.

     Regier also complained the article used “guilt by association” to impugn panel members.“There’s an implication that there shouldn’t be any association between the writers and the pharmaceutical industry,” Regier said in a telephone interview today. “We think there should be. The best experts in the field are working at the intersection between academia and the industry. We want those people involved, and we want full disclosure of their financial interests.”

                      `Crisis of Confidence’
     Spitzer acknowledged that many academic psychiatrists double or triple their incomes with funding from the drug industry, undermining trust in the results of drug research. “There is a crisis of confidence in the reliability of drug trials because of the undue influence of the pharmaceutical industry,” he said.

     That crisis of confidence extends to psychiatrists in private practice who struggle to figure out what treatments are valid and which studies are credible, said Ross Andelman, chief psychiatrist for children’s mental health services in Contra Costa County, California.      The new findings “contribute to the erosion of trust among front-line clinicians in our academic colleagues,” Andelman said in a telephone interview yesterday.

To contact the reporter on this story:  Rob Waters in Washington at (1) (202) 624-1990 or  rwaters5@bloomberg.net.
To contact the editor responsible for this story:
Robert Simison at (1) (202)
~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.nj.com/search/index.ssf?/base/business-0/1145507870120320.xml?starledger?bpha&coll=1
Star-Ledger
Study links money with drug experts
Pharma funded speakers, consultants and research
Thursday, April 20, 2006
BY ED SILVERMAN

The doctors who recommended diagnostic standards for the nation’s leading psychiatric manual had numerous undisclosed financial ties to the pharmaceutical in dustry, which may have unfairly encouraged the use of prescription medicines to treat such widespread mental illnesses as depression and schizophrenia, according to a study to be released tomorrow.

The study found 56 percent of 170 doctors had financial links including research funding, consulting income or serving on a speaker’s bureau. The financial associations were obtained by reviewing patent holdings, speaking engagements and financial disclosures in medical journals between 1989 and 2004.

Financial ties were strongest among doctors who set criteria for diagnosing mood disorders and schizophrenia, which the study called a "cause for concern," be cause prescription drugs to treat these disorders are big sellers. In 2004, global sales of depression and schizophrenia pills totaled $34.4 billion, according to sales data cited by the authors.

"This is an important diagnostic tool, but there’s no transparency and that’s an issue because there’s a lot of subjectivity in determining treatment," said Sheldon Krimsky, a science-policy expert and profes sor at Tufts University and co-author of the study, which appears in the latest edition of the Psychotherapy and Psychosomatics medical journal.  "We can’t get into the minds of the people who are on the panels making these decisions," he continued. "But doctors and researchers need to know about potential bias. And the public should know about any relationships to an industry that wants to sell drugs."

The Diagnostic and Statistical Manual of Mental Disorders, which is often described as the psychiatrist’s bible, was last published in 1994 and given minor updates in 2000 by the American Psychiatric Association. A new version, which would be the fifth edition, is in the works.  The manual doesn’t contain specific recommendations for treat ing patients, but psychiatrists regularly refer to the diagnostic criteria for understanding mental disorders

The findings come amid grow ing controversy about the extent to which influential physicians and academics have undisclosed ties to drugmakers. The issue has engulfed experts who sit on Food and Drug Administration advisory panels or conduct industry-funded research that is published in widely read medical journals.

An official of the APA dismissed the study as "innuendo."  "It’s not a scientific paper," said Darrel Regier, the APA’s research director, who noted the organization instituted a financial disclosure policy about six years ago and so was unaware who had financial ties when the doctors met in 1994 to set diagnostic standards.

"But they’re making an implication that by being a member of the 1994 panel, they enhanced their expertise and then used this in order to get lucrative contracts. There’s no indication they did so. And they say that. They’re just hyping the percentage of those who had some financial ties to the pharmaceutical industry."

The authors conceded it was unclear when all of the financial ties existed and that conclusions couldn’t be drawn on the impact those may have had on a doctor’s behavior. Nonetheless, they insisted "ethical concerns" remain, regardless of the amount of money involved or the timing of the financial tie.  "A financial relationship held during or just before participation as an expert panel member might influence or be perceived to influence the outcome," the authors wrote.

Lisa Cosgrove, a co-author and psychology professor at the University of Massachusetts in Boston, added that drugmakers have a "vested interest" in which mental disorders are included in the manual. As an example, she cited newly classified illnesses such as social anxiety disorder or premenstrual dysphoric disorder, a form of premenstrual syndrome.
One industry critic said the study was disturbing.

"This is extremely serious," said Vera Sharav of the Alliance for Human Research Protection, a consumer-advocacy group that has chastised drugmakers for not disclosing clinical-trial data or conflicts of interest. "It overturns the integrity of the diagnostic manual. They’ve lost all credibility."

Ed Silverman may be reached at esilverman@starledger.com or (973) 392-1542.
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<http://www.washingtonpost.com/wp-dyn/content/article/2006/04/19/AR2006041902560_pf.html>  
Washington Post
Experts Defining Mental Disorders Are Linked to Drug Firms
By Shankar Vedantam
April 20, 2006; A07

Every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses, a new analysis has found.

Of the 170 experts in all who contributed to the manual that defines disorders from personality problems to drug addiction, more than half had such ties, including 100 percent of the experts who served on work groups on mood disorders and psychotic disorders. The analysis did not reveal the extent of their relationships with industry or whether those ties preceded or followed their work on the manual.

"I don’t think the public is aware of how egregious the financial ties are in the field of psychiatry," said Lisa Cosgrove, a clinical psychologist at the University of Massachusetts in Boston, who is publishing her analysis today in the peer-reviewed journal Psychotherapy and Psychosomatics. The analysis comes at a time of growing debate over the rising use of medication as the primary or sole treatment for many psychiatric disorders, a trend driven in part by definitions of mental disorders in the psychiatric manual.

Cosgrove said she began her research after discovering that five of six panel members studying whether certain premenstrual problems are a psychiatric disorder had ties to Eli Lilly & Co., which was seeking to market its drug Prozac to treat those symptoms. The process of defining such disorders is far from scientific, Cosgrove added: "You would be dismayed at how political the process can be."

The American Psychiatric Association, which publishes the guidelines in its bible of disorders, the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual — due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world.

Darrel Regier, director of the association’s division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts.

Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc. "It shouldn’t be assumed there is a true conflict of interest," said Kane, who said his panel’s conclusions were driven only by science. "To me, a conflict of interest implies that someone’s judgment is going to be influenced by this relationship, and that is not necessarily the case. . . ."

The DSM defines disorders in terms of constellations of symptoms. While neuroscience and genetics are revealing biological aspects to many disorders, there has been unease that psychiatry is ignoring social, psychological and cultural factors in its pursuit of biological explanations and treatments.  

"As a profession, we have allowed the biopsychosocial model to become the bio-bio-bio model," Steven Sharfstein, president of the American Psychiatric Association, said in an essay last year to his colleagues. He later added, "If we are seen as mere pill pushers and employees of the pharmaceutical industry, our credibility as a profession is compromised."

He stressed that the association has strict guidelines to police the role of the pharmaceutical industry but said the profession as a whole needs to do a better job monitoring ethical conflicts. Sharfstein added yesterday that the presence of experts with ties to companies on the manual’s expert panels is understandable, given that many of the top experts in the field are involved in drug research.

"I am not surprised that the key people who participate have these kinds of relationships," he said. "They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship — but there should be full disclosure."

At least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward.

Two out of five researchers on her team had had substantial ties to industry, she said. Andreasen said she would have to check her tax statements to know whether she received money from companies at the time she worked on the panel, but said, "What I do know is that I do almost nothing with drug companies. . . . My area of research is neuroimaging, not psychopharmacology."

The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said.
Krimsky, the author of the book "Science in the Private Interest," added that although more transparency is welcome, the psychiatric association should staff its panels with disinterested experts.

"When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions," he said.

© 2006 The Washington Post Company

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