How To Deter Pharma Conflict Of Interests: Have FDA, CMS Grade Cost-Effectiveness

JAMA editorial suggests ways to reduce conflicts of interest in industry marketing; study shows restricting pharmaceutical detailing at academic medical centers led to 1.67% mean absolute reduction in market share of detailed drugs.

An editorial in the Journal of the American Medical Association proposes that FDA and the Centers for Medicare and Medicaid Services could help avoid conflicts of interest inherent in pharmaceutical detailing by educating physicians about the cost-effectiveness of drugs.

If CMS or FDA "were given the authority to evaluate and grade cost-effectiveness, those agencies could advise physicians about therapeutic equivalence and the highest-value options within each drug class. Online resources could be made available to physicians that would allow them to compare the quality of evidence, incremental benefits, and cost of drugs within common treatment categories," write Colette DeJong and Adams Dudley of the University of California at San Francisco.

They note that the Department of Veterans Affairs' Pharmacy Benefits Management Service and the UK's National Institute for Health and Care Excellence currently make similar determinations about drugs.

Their editorial is included in JAMA's May 2 issue, which is devoted to conflicts of interest in the pharmaceutical industry and medical community. It accompanies a study that found restricting pharmaceutical sales visits at academic medical centers was associated with a modest reduction in prescribing of detailed drugs across six of eight drug classes.

The study, led by Ian Larkin of the University of California, Los Angeles and funded in part by the National Institute of Mental Health, analyzed 16.1 million prescriptions written between January 2006 and June 2012 by 2,126 attending physicians at 19 academic medical centers and a matched control group of 24,593 physicians. During this period, the centers instituted policies that restricted detailing by pharmaceutical representatives.

The authors found that enactment of these policies was associated with a 1.67% decrease in the market share of detailed drugs and a 0.84% increase in the market share of nondetailed drugs. They report that both estimates were statistically significant in the full sample, but were only statistically significant for nine of the 19 individual academic medical centers.

They note that the study has several limitations, including its observational design, which precludes proving causal relationships. They say some academic medical centers likely underwent other changes around the time they enacted detailing policies. However, the authors say the study had several strengths, including its difference-in-differences design, that suggest the most likely explanation for the associations was that the policies influenced prescribing behavior.

48% Of US Physicians Received Industry Payments In 2015

The JAMA package also includes a study of industry-related payments to physicians in 2015 based on data from CMS' Open Payments database. The authors, led by Kathryn Tringale, of the University of California, San Diego School of Medicine, found that 48% of all US physicians (449,864 of 933,295) were reported to have received $2.4bn in industry payments. The sum includes approximately $1.8bn for general payments, $544m for ownership interests, and $75m for research payments.

They also found that surgeons were more likely to receive payments, and higher value payments, than those in primary care specialties and that men within each specialty had higher odds of receiving general payments than women. Men were also more likely than women to have been reported to receive royalty or license payments across all specialties. The authors point out that women hold fewer patents than men and women who obtain patents are less likely than men to have commercialized or licensed them.

In a viewpoint article, Robert Steinbrook, of Yale School of Medicine, notes that the 2015 physician payments included $235m in food and beverages, which was approximately 12% of general payments.

He cites a 2016 study by DeJong, et al., published in JAMA Internal Medicine that found that just a single industry-sponsored meal was associated with an increase in the rate of prescribing the brand-name drug that was being promoted.

"Physicians have to ask why they are accepting this industry largesse," Steinbrook says. "Each year, $235 million would pay for considerable needed care for patients who cannot afford it or essential clinical research. Instead of dining on meals from industry, physicians should be advocating for drug and device manufacturers to spend less on promoting their products and more on independent bona fide research on safety, effectiveness, and affordability."

In another viewpoint piece, Bernard Lo, of the Greenwall Foundation, and Deborah Grady, of UC San Francisco, note that five physicians received the largest total payments in the Open Payments database from August 2013 through 2015, with each receiving more than $28m. The physicians were inventors, owners, and officials of companies that were purchased by the company reporting the payment.

Lo and Grady say there is currently no data to say at what point large payments clearly imply an unacceptable likelihood of bias or undue influence. They also comment that the type of payment matters as much as the amount, asserting that payments should be encouraged for inventions leading to treatment, for developing effective new therapies, and for valid research.

Company Investigators May Not Get Author Credit

The JAMA issue includes a total of 23 viewpoint articles and three editorials addressing conflict of interest broadly and among specific groups. In an editorial on conflict of interest and medical journals, JAMA Executive Editor Phil Fontanarosa and Editor in Chief Howard Bauchner describe the journal's conflict of interest policies and issues regarding research reports.

They note that in discussions with investigators at biopharmaceutical companies, it is clear that in some cases, they are involved in the design and conduct of randomized clinical trials. "Some of these investigators have expressed concern that they may be excluded as authors or have been encouraged to add academic authors to ensure that their study would be fairly assessed in the review process," they write. "This is disturbing and unfair."

The editors also say that over the past few years, it has become clear that a number of governmental agencies are providing greater oversight for manuscripts that are either prepared by their employees or funded with resources from those agencies. "In some cases, even though this review process may be part of the legislative mandate of the agencies, this level of oversight of research manuscripts raises concerns," they write.

They say it is not clear how often manuscripts have been delayed or changed because of these reviews. "However, all authors should be afforded the protection and academic freedom to publish the results of studies regardless of the interest of the funder, whether a governmental agency, foundation, or for-profit company," they state.