Friday, March 26, 2010

Thomas R. Insel, MD - Psychiatrists' Relationships With Pharmaceutical Companies

http://www.thatnaturalstore.com/information/cartoons/cartoons2/big_pharma_600.jpg

In this recent JAMA article, Dr. Insel takes a look at the issue of psychiatrists and the pharmaceutical companies essentially being in bed together (and the FDA has really failed to supervise this reality, thus the cartoon) - and the resulting loss of respect from the public. Seroquel is one of many examples where Big Pharma pushes a drug they know is harmful, even getting it approved for kids. The MDs are complicit in this.

[Furious Seasons is the best blog on the Web for keeping up with Big Pharma's collusion with psychiatry to promote harmful drugs.]

I agree with Dr. Insel that there is a problem. But it's much bigger than whether or not psychiatrists are being paid by the pharmaceutical companies to study and promote their products. The REAL problem in my mind is that psychiatry is moving toward a complete medical/disease model of mental illness, which totally negates the large and real influence of culture, experience, and other factors that cannot be treated with a drug.

I also realize that this brings into question how we conceive of the mind. Is mind a by-product of electro-neural function in the brain, or is it an emergent property of body-brain, experience, culture, environment, and temporal factors?

How we answer this question will finally shape, at least in part, how we treat mental illness. For those who work in the trenches as counselors, the biopsychosocial model has already move into the mainstream. I wish this were true in psychiatry as well.
Psychiatrists' Relationships With Pharmaceutical Companies

Part of the Problem or Part of the Solution?

Thomas R. Insel, MD

JAMA. 2010;303(12):1192-1193.

Psychiatrists have rarely enjoyed a surplus of public trust. During the past 3 years, public trust in psychiatry has been further undermined with accusations that several leading academic psychiatrists failed to disclose financial conflicts of interest. Sen Charles Grassley (R, Iowa), ranking member of the Finance Committee, has thus far accused 7 psychiatrists of failing to disclose income from pharmaceutical companies. As public trust in the pharmaceutical industry has plummeted, the close connection between leading psychiatrists and the pharmaceutical industry, once a sign of progress for the profession, is now cited as evidence of corrupt influence.1

The investigations spawned by these allegations already have had major effects, including restrictions on outside income, removal of investigators from National Institutes of Health (NIH) grants, and the resignation of the chair of a prestigious psychiatry department. Conflict of interest policies at many US universities have been enhanced to provide more rigorous requirements for disclosure. The National Institute of Mental Health (NIMH), which funded some of the accused individuals, has initiated an internal review system to detect potential problems with the management of financial conflicts of interest and has implemented changes to minimize possible bias in its funded studies. More broadly, the NIH is substantively revising its regulations on financial conflict of interest, which were originally adopted in 1995. The proposed new regulations are slated to be available for public comment in early spring 2010. But one of the largest effects of this scandal has been to raise a difficult and still unanswered question about the integrity of psychiatrists. Is the financial conflict of interest problem worse for psychiatrists or are psychiatrists just an easy target? A review of evidence is in order.

First, are psychiatrists in clinical practice receiving more industry money than other specialists? Although several states now require public disclosure of all pharmaceutical industry payments to physicians, only in Vermont are the results currently available in a form that permits comparisons across specialties. In Vermont, psychiatrists received more money from pharmaceutical companies than all other medical specialists.2 Complementing state disclosures, several pharmaceutical companies are volunteering to post payments to physicians. For instance, Eli Lilly lists 25 faculty (speakers, consultants, etc) receiving more than $50 000 in the first 3 quarters of 2009.3 Of these top 25 faculty, 17 were psychiatrists. Lilly's major investment in psychotropic medications may skew this sample relative to other pharmaceutical companies. For example, comparable data from Merck, which markets drugs for diabetes and cancer, show overrepresentation of payments to endocrinologists and oncologists, with no payments to psychiatrists.4 Not surprisingly, companies are paying the specialists most likely to promote or prescribe their products.

These data from state and company registries largely reflect payments to practicing physicians. As a second question, what about academic thought leaders and researchers who may influence practice through publications and lectures? In a recent study of all medical school department chairs, 60% reported receiving personal income from industry, most often as a consultant or member of a scientific advisory board. In the clinical departments, 80% of faculty reported a departmental relationship with industry, most often for support of continuing medical education.5 There is no published evidence that departments of psychiatry or chairs of these departments receive more or less industry funding than their colleagues in other specialties.

Third, are academic psychiatrists disclosing more financial interests in publications? Relative to other professional journals, the major psychiatric journals appear to have comparable standards for disclosing financial interests.6 Based on a review of 397 published reports of clinical trials in 4 psychiatric journals, Perlis et al7 found that 60% had industry funding and 47% had at least 1 author reporting a financial relationship. The prevalence of industry funding in general medical journals has been reported to range from 40% to 66%, with author industry support reported between 34% and 43%, slightly lower than reported in psychiatry journals. Importantly, Perlis et al7 noted that articles with reported industry support were nearly 5 times more likely to report positive results.

Fourth, do financial payments to academic leaders influence clinical practice guidelines? Cosgrove et al,8 reviewing the 20 work group members who authored the American Psychiatric Association guidelines for the treatment of schizophrenia, bipolar disorder, and major depressive disorder, reported that 90% had financial ties to industry (72% as consultants). None were disclosed. A review of 192 authors of 44 clinical practice guidelines for multiple common adult diseases found 87% with some form of industry involvement, and in only 2 cases were disclosures included.9

Because industry support to academic departments, individual scientists, and academic leaders in these various surveys appears to be widespread, it is difficult to conclude that academic psychiatrists receive more or disclose less than their colleagues in other areas of medicine. But what is clear is that current pharmaceutical industry investment in academic psychiatry is prevalent.

As a final question, setting aside the relative magnitude of disclosed or undisclosed financial relationships, is psychiatric practice biased by industry? Certainly psychiatric treatments have become largely pharmacological. Antidepressants and antipsychotics represent 2 of the top 5 classes of medications sold in the United States, with combined sales in excess of $25 billion in 2008.10 Although several large-scale studies have demonstrated equivalent effectiveness of older, off-patent (generic) antipsychotics and antidepressants, more expensive, patented compounds continue to hold the majority of the market share. But aside from the evident success of marketing of specific medications, what is perhaps most worrisome is the relative neglect of effective nonpharmacological interventions such as cognitive-behavioral therapy for mood and anxiety disorders or powerful psychosocial interventions for schizophrenia. Numerous studies have demonstrated the effectiveness of such interventions, and their use has been recommended in the practice guidelines mentioned above, yet they are woefully underused and frequently not reimbursed.

The bias in prescribing practices and the conspicuous tilt toward pharmacological interventions are not unique to psychiatry. But this in no way diminishes the severity of the problem in psychiatry. The focus on financial conflicts of interest in psychiatry is an opportunity to take the lead in setting new standards for interactions between all medical disciplines and industry. Academic leaders, professional societies, and patient advocacy groups could turn the tables of public trust by developing a culture of transparency for psychiatry's collaborations with industry, including the clear separation of academic-clinical missions from industry marketing.

There is no denying the need for academic and industry scientists to collaborate. Indeed, the public health imperative for scientific collaboration is formidable. Families struggling with schizophrenia, bipolar disorder, and other psychiatric illnesses are seeking a new generation of treatments. Current medications are not good enough. Public trust will ultimately depend on finding better treatments, but this goal can only be reached if psychiatry finds a way for academic investigators to interact with industry without real or perceived financial conflicts of interest. New NIH regulations will increase clarity and rigorous NIMH oversight can ensure better management, but academic leaders and their professional societies will need to transform what has become a culture of influence. The greatest threat to an era of improved public health stemming from the productive and ethically sound relationship among academia, industry, and practice is a defiant embrace of the status quo, in which psychiatrists are seen as a leading source of the problem rather than as leaders in finding the solution for financial conflicts of interest.


AUTHOR INFORMATION


Corresponding Author: Thomas R. Insel, MD, National Institute of Mental Health, 6001 Executive Blvd, Room 8235, Bethesda, MD 20892 (tinsel@mail.nih.gov).

Financial Disclosures: None reported.

Author Affiliation: National Institute of Mental Health, Bethesda, Maryland.


REFERENCES


1. Freedman R, Lewis DA, Michels R; et al. Conflict of interest—an issue for every psychiatrist. Am J Psychiatry. 2009;166(3):274. FREE FULL TEXT
2. Vermont Office of the Attorney General. Pharmaceutical Marketing Disclosures July 1, 2007-June 30, 2008: Report of Vermont Attorney General William H. Sorrell. April 2009. http://www.atg.state.vt.us/assets/files/2008%20Pharmaceutical%20Marketing%20Disclosures%20Report.pdf. Accessed February 19, 2010.
3. Sandburg B. Lilly outside "faculty" is headed by 22 physicians receiving $50 000 or more. BioPharma Today. October 29, 2009. http://www.biopharmatoday.com/2009/10/lilly-outside-faculty-is-headed-by-22-physicians-receiving-50000-or-more.html. Accessed February 4, 2010.
4. Merck. Disclosure of Payments to US Speakers for Promotional (Non-CME) Medical Education Activities Conducted in 3Q 2009. http://www.merck.com/corporate-responsibility/docs/business-ethics-transparency/3Q09-Transparency-Report.pdf. Accessed February 4, 2010.
5. Campbell EG, Weissman JS, Ehringhaus S; et al. Institutional academic industry relationships. JAMA. 2007;298(15):1779-1786. FREE FULL TEXT
6. Blum JA, Freeman K, Dart RC, Cooper RJ. Requirements and definitions in conflict of interest policies of medical journals. JAMA. 2009;302(20):2230-2234. FREE FULL TEXT
7. Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry. 2005;162(10):1957-1960. FREE FULL TEXT
8. Cosgrove L, Bursztajn HJ, Krimsky S, Anaya M, Walker J. Conflicts of interest and disclosure in the American Psychiatric Association's Clinical Practice Guidelines. Psychother Psychosom. 2009;78(4):228-232. FULL TEXT | WEB OF SCIENCE | PUBMED
9. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002;287(5):612-617. FREE FULL TEXT
10. IMS Health. Top line industry data: 2008 US sales and prescription information. http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=85f4a56216a10210VgnVCM100000ed152ca2RCRD&cpsextcurrchannel=1. Accessed February 4, 2010.


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