IOM Issues A “Scolding, Stinging and Damning” Report Concerning Financial Conflicts of Interest in American Medicine
The Institute of Medicine has issued a “scolding,” “stinging,” and “damning” report about financial conflicts of interest in American medicine involving pharmaceutical, medical device, and biotechnology companies.
If enacted, the IOM recommendations will essentially sever the financial ties that bind American medicine–its practitioners, researchers, academic institutions, journals, professional association and so-called “advocacy groups” from industries that have derailed American medicine from its humanitarian public mission.
Dr. David Rothman, whose Institute on Medicine as a Profession at Columbia University (which is bankrolled by financier George Soros) is quoted saying:
“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable; conflicts of interest in medicine are no longer acceptable.”
Most important, the IOM report calls upon Congress to pass legislation that would require drug and device makers to publicly disclose all payments made to doctors–thereby lending important support for the Physician’s Payment Sunshine Act, sponsored by Senators Charles E. Grassley, and Herb Kohl who head the Senate Finance Committee that would do just that.
The IOM report acknowledges that:
“financial ties between medicine and industry may create conflicts of interest. Such conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine. Recent news stories have documented troubling interactions between industry and physicians, researchers, and medical institutions.”
Though not identified, many of those news stories laid bare gross and pervasive financial conflicts of interest by psychiatry’s leadership, its professional associations, diagnostic and therapeutic practice guidelines, and the academic institutions they are affiliated with–all have been shown to be tainted by industry’s tentacles. In no other field of medicine have doctors sworn to “do no harm” knowingly prescribed toxic drugs that carry warning labels about induce suicide, metabolic syndrome, diabetes, and cardiac death.
Recently, Gabriel Myers, a seven-year old boy committed suicide. The child was treated by a “board certified” child psychiatrist in Florida who prescribed four psychotropic drugs for the boy including: the antidepressant, Lexapro, the antipsychotic, Zyprexa, and Eli Lilly’s deadly combination Symbiax (Zyprexa and Prozac). These three drugs were not approved for use in children though they are recommended by the most influential industry-paid child psychiatrists–all carry Black Box warnings which the treating psychiatrist ignored.
Clearly, the IOM committee–including the deans of Emory University and Stanford University who served as external reviewers of the draft report, according to Dr. Bernard Carroll–now recognize that financial relationships with industry are extensive and self-regulation by academic institutions has failed to rein in the most serious conflicts of interest. Indeed, as Dr. Carroll notes on his blog, HealthCareRenewal, both of these deans were confronted with evidence uncovered by the Senate Finance Committee that their institutions’ prominent (now former) chairmen of psychiatry were shown to have multi-million dollar undisclosed financial interests that posed serious conflicts of interest undermining both human subject safety and the integrity of the research findings.
To combat the current state of confusion created by variable conflict of interest policies adopted by various academic institutions, journals and professional societies, the IOM committee recommends a real universal overhaul that would prohibit financial ties between industry and researchers conducting human research; end industry funding for continuing medical education programs (within two years); end industry payments physician practice guidelines:
“Congress should create a national reporting program that requires pharmaceutical, medical device, and biotechnology companies to make public all payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, and providers of continuing medical education. Public reporting will enhance accountability by allowing academic medical centers, medical journals, and others to verify disclosures made to them by faculty members, article authors, and others.”
Research: “as a general rule, that researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. The only exceptions should be if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research.”
Continuing medical education: “a broad-based consensus process to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence….”a new system of funding … should be developed that is free of industry influence.”
Community physicians: “should also follow the restrictions described previously regarding gifts, including meals, from companies; presentations or articles whose content is controlled by industry; meetings with sales representatives; and use of drug samples.”
Clinical practice guidelines: “influence physician practice, quality measures, and insurance coverage decisions. Given this influence, clinical practice guidelines need to be developed with greater transparency and accountability.
“The committee recommends that professional societies and other groups that develop practice guidelines not accept direct industry funding for guideline development and generally exclude individuals with conflicts of interest from the panels that draft the guidelines
“To reduce the risk for bias within the learning environment, academic medical centers and teaching hospitals should prohibit faculty from accepting gifts, making presentations that are controlled by industry, claiming authorship for ghost-written publications, and entering into consulting arrangements that are not governed by written contracts for expert services to be paid for at fair market value.”
The committee also recommends that: “the Department of Health and Human Services develop a research agenda to create a stronger evidence base for future conflict of interest policies. Such research should evaluate the impact of conflict of interest policies, including both desired outcomes and possible unwanted consequences.”
“Decisions about biomedical research, medical education, and patient care directly affect the public’s health. The public needs to be able to trust that physicians’ decisions are not inappropriately influenced by their financial relationships with industry.”
Although the IOM does not have the power to enforce its recommendations, the Institute usually carries great weight within the medical profession and health-care industry.
Sources: IOM. Conflict of Interest in Medical Research, Education, and Practice
REPORT BRIEF • APRIL 2009 http://www.iom.edu/Object.File/Master/65/981/COI report brief for web.pdf
See also, Peeling the onion: Is more conflict of interest disclosure getting us closer to the truth?
April 24, 2009 | Shelley Wood, The Heart.org WebMD:
Zenneia McLendon says
Hi, I’m writing from the National Academies. We are delighted to see that the report “Conflicts of Interest in Medical Research, Education and Practice” is continuing to garner such attention. We wanted to ensure that your readers have an opportunity to read this report, it is available to read online at http://bit.ly/NPHtx. We hope that by reading this report it will enhance the conversation.