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Comments on ethical and practical issues regarding commercial support of continuing medical education

Consumers Union Comments on Ethical and Practical Issues Regarding
Commercial Support of Continuing Medical Education

February 23, 2009
Consumers Union has been asked to “share reflections” on key questions regarding commercial support of physician continuing medical education with the Council on Ethical and Judicial Affairs and Council on Medical Education of the American Medical Association. We appreciate the chance to comment.
Physicians have a unique responsibility to patients as professionals that includes not only clinical responsibilities but fiduciary responsibilities. Professional codes of behavior repeatedly emphasize the commitment of physicians to put patient interests before their own. Healthcare has become a complex process for patients as government has stepped back from market regulation and industry has developed sophisticated techniques for presenting information favorable to its products to doctors and patients.
The American healthcare system is not performing well. Significant numbers of Americans have become impoverished by the cost of healthcare. Hundreds of thousands of Americans have been harmed, and some have died, because of preventable adverse effects and errors by the healthcare industry. The need for physicians to step up to their fiduciary responsibilities related to cost and safety has never been more critical. Physicians who have financial relationships with industry introduce an inevitable and unavoidable bias into the patient relationship that increases costs and may create safety concerns.
Financial relationships with industry undermine the ability of physicians to present themselves as capable fiduciaries to patients. Industry efforts to influence physicians through financial relationships are frequent, coordinated, diverse and effective. Billions of dollars are spent by pharmaceutical and device manufacturers to influence physicians. Despite many physicians’ claim that such efforts do not influence them, the evidence is strong to the contrary. Surveys of physicians repeatedly show that they do not think financial relationships influence them but they do think financial relationships influence other physicians. Surveys of consumers, including our own Consumers Union surveys, indicate patients have very strong concerns about these financial relationships and believe only the most trivial of gifts are acceptable. Our surveys specifically indicate patients are concerned about financial relationships around activities involved in continuing medical education—paying doctors to give talks, paying doctors to attend talks, paying any expenses related to conferences.
The good news for physicians is that patients continue to have high levels of trust in their individual clinical skills. The same is not true for the pharmaceutical industry. Our surveys and others suggest that physicians are at risk for losing the trust of patients when it comes to cost and safety. When physicians have significant financial relationships with industry, they put themselves at risk. When a mistake or adverse event occurs, and a physician involved has a financial relationship with a drug or device company involved in the concern, it is only natural to question the basis of the physician’s decision process.
Our specific reflections to the Councils regarding these issues are as follows:
1. Reflections regarding ethically preferable practices with respective to commercial funding of CME.
The only ethically preferable practice with respect to commercial funding for CME is prohibition of such funding.
2. Reflections on ethically permissible practices, including strategies for managing or mitigating potential conflict of interest or bias.
There are no ethically permissible strategies that can successfully manage or mitigate commercial funding in CME short of prohibition. If an organization is unwilling to prohibit commercial funding and accepts the compromised ethical position this creates, we believe that all the details of the financial relationship must be fully disclosed, including the specific value, nature and duration of the financial relationship. The practitioners in the audience must be made aware of the relationship and warned to disclose to patients that advice they provide to patients as a result of this CME has been compromised by this bias.
3. Reflections on ethically permissible practices in situations involved in uniquely qualified but unavoidably conflicted parties.
Accepting financial relationships as “unavoidable” is not applicable to commercial funding. Industry information sources (individuals or studies) that are considered “uniquely qualified but unavoidably conflicted” can be included in CME but must be identified, their bias clearly articulated and appropriate information provided to balance the biased information presented. If information is not presented that balances industry information the audience will need to be informed of this imbalance and any efforts of the industry to suppress other information.
4. When is conflicted expertise essential in CME? How can we tell when it is no longer needed?
CME should include all information that meets reasonable evidence standards. Often industry information is so obviously biased it does not meet those standards and neither time nor attention to it in CME is deserved. When industry information meets at least a minimal standard it may be presented but care must be taken to inform the audience of possible bias and balancing information must be presented. It should be presented by a source/individual free of industry financial relationships.
5. What unique challenges do you as a stakeholder face regarding CME?
The pharmaceutical and device industries have substantial economic resources. Any exceptions to prohibition of industry financial involvement in CME will likely be exploited by the industry. The drug and device industries have hundreds of thousands of employees involved in marketing and information efforts. These employees often have substantial group and individual incentives to sell products. We believe current voluntary codes of behavior do not cover many important areas and are often violated.
6. How can we ensure that medicine sets the agenda for CME overall so that it meets the needs of patients and physicians rather than the interests of commercial supporters?
If the AMA desires to “ensure that medicine sets the agenda for CME” we believe the only credible option is to prohibit all industry financial involvement in CME. Physicians have been major beneficiaries of the financial success of the healthcare industry. Current technology enables CME to be provided in multiple ways that are credible, efficient and free of conflict of interest. It is time for medicine to take care of its own without the constant influence of industry and manipulation of the profession.
It is very important to consumers that doctors be well informed and current. We believe there are many sources of information that will accomplish that for doctors without industry financing. The work the Councils are doing is critically important to transforming this very crucial part of American medicine.
Thank you for the opportunity to share these comments.
James A. Guest
President & CEO,
Consumers Union
Yonkers, New York