There have been near constant allegations of inappropriate industry influence on prescriber prescribing habits. Inappropriate promotion has already resulted in multibillion dollar fines. To further address these habits on influence, the Open Payments Database (resulting from the Sunshine Act) was put into place. The Sunshine Act requires companies to disclose any transfers of value made to physicians. However, certain payments made to CME (Continuing Medical Education) companies are exempt from such disclosures. This has upset individuals and organizations who assert that such payments represent an unchallenged influence on prescribing habits.
Is Anyone Really Serious About It?
At first blush, it seems as though the education of physicians by unbiased third parties is a win-win for physicians and patients alike. However, detractors claim that CMEs in general and the Accreditation Council for Continuing Medical Education (ACCME) in particular obscures the influence of life science company funding.
Daniel Carlat, associate clinical professor of psychiatry at Tufts School of Medicine, believes that “companies spend money on textbooks and continuing education in order to promote their products. To pretend otherwise is naïve.”
Dr. Carlat’s view is echoed by Dr. Adriane Fugh-Berman and Alycia Hogenmiller who direct PharmedOut, a Georgetown University Medical Center project that “encourages rational prescribing.” Of note, Dr. Fugh-Berman is also a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices. Dr. Fugh-Berman and Ms. Hogenmiller believe that CMEs are methods used to “[position] invented diseases prior to product launch, [convince] physicians of ‘unmet needs,’ [expand] populations eligible for treatment (pre-diabetes, pre-hypertension), [exaggerate] adverse effects of competing therapies, [minimize] concerns about targeted drugs and [identify] emerging (i.e. unproven or disproven) uses of drugs.”
This divisive topic has made for strange bedfellows since Dr. Carlat, Dr. Fugh-Berman and Alycia Hogenmiller were joined by UNITE HERE. UNITE HERE represents 70,000 individuals in North America who work in the hotel, gaming, food service, manufacturing, textile, distribution, laundry, transportation, and airport industries. UNITE HERE has filed a petition calling on ACCME to change the rules and eliminate pharmaceutical industry funding from CME events.
What Do Detractors Actually Want?
Dr. Fugh-Berman and Alycia Hogenmiller, while calling for an outright ban of industry funding of CME, additionally assert that ACCME should:
- include in-kind funding as income, and disclose commercial support;
- disclose the proportion of advertising and exhibits funded by industry; include industry-funded exhibits and advertising income as commercial support;
- disclose the proportion of individual CME providers’ activities that receive commercial support;
- disclose the titles and sponsors of individual CME activities and
- disclose the conflicts of interest of individual presenters.
Ban of Life Science Funding: Best for Patients?
The outright ban of funding CMEs by life science companies will be in the best interests of patients if (1) It is reasonable for physicians to be more willing to attend CMEs paid for by life science companies, and (2) Physicians can make better clinical decisions as a result of a lack of funding by life science companies, or (3) The potential of a biased view is a detraction from life science company sponsored CMEs.
Is Physician Attendance Reasonable?
Contrary to popular belief, physicians are not making money hand over fist. Physicians have some of the highest IQs on the planet. However, according to CBS News, despite taking 11 to 14 years of higher education, the average newly minted physician has $166,750 in medical school debt and doesn’t earn a full-time salary until ten years after the typical college graduate starts making money. Additionally, physician average salaries are declining, with nearly one-third of doctors (28 percent) seeing a cut in pay last year. According to Medscape, 22% of physicians are still paying school loans until they are 50 years old. CBS News has dubbed the decision to become a physician a “$1 million mistake.” It is then not unreasonable for them to undertake cost-cutting measures in order to maintain their license to the extent possible. To educate themselves via CMEs, which are already provided by unbiased third parties with strict policies to ensure independence in CME activities, seems like a reasonable step to take.
Could Physicians Make Better Clinical Decisions?
The PhRMA Code on Interactions with Healthcare Professionals, the Sunshine Act and other well meaning laws have significantly reduced the number of interactions life science sales professionals have with clinicians in general and physicians in particular. This would typically have been judged as a good result. However, a study by Temple University indicates that this is not as accurate as one may believe. Specifically, doctors who didn’t interact with drug reps were about four times less likely to respond to either positive (new drug available) or negative (safety issues, lack of efficacy) information than doctors who allowed some access to pharmaceutical representatives. If physician-sales representative interaction, which has a purely commercial function, results in potentially worse clinical decisions, it is unlikely that education seminars provided by physicians not paid by life science companies would cause clinicians in general and physicians in particular to make potentially worse clinical decisions. With that being said, it is simply untrue that physicians could make better clinical decisions as a result of the lack of funding by life science companies.
Potential of a Biased View
For the sake of argument, assuming that the funding of CMEs by life science companies represents a biased viewpoint that corrupts feeble-minded physicians into prescribing whatever a specific life science company deems appropriate, the Supreme Court has repeatedly held, as early as 1927, that it is insufficient to merely allege the risk of lies to suppress such speech. In fact, as per the Supreme Court, it is better to expose such lies through discussing the “falsehood and fallacies.” Accordingly, the Court held that “the remedy to be applied is more speech, not enforced silence.” So, even if it were true that there is the potential of a biased view of a drug or disease from CMEs, this would be cause to require more, not less, CME credits from physicians. Accordingly, the potential of a biased view is not a detraction from life science company sponsored CMEs.
Since it is reasonable for physicians to be more willing to attend CMEs paid for by life science companies, true that physicians wouldn’t necessarily make better clinical decisions as a result of lack of funding by life science companies, and evident that the mere potential of a biased view is not a detraction from life science company sponsored CMEs, the outright ban of funding CMEs by life science companies will not be in the best interests of patients.
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