Primacea Blog

Primacea's founders describe the problems and pathways for physicians to manage their industry relationships under the bright lights of the Sunshine Act in a March 2013 Endovascular Today cover story.

"From inventing a new device to providing expertise on how it might be improved or best used, physicians interact with industry in a variety of ways, often receiving paid compensation for their time and work or being provided with meals or travel expenses. While ordinarily understood to be of value by many within the field, public and political scrutiny has increased in recent years, and legislation now dictates that all financial ties be disclosed publicly, online."

The interview describes the background of the Sunshine Act, how it grew to 76,000 words of regulations, and the reporting responsibilities around financial exchanges between industry and physicians.

It emphasizes the need for physicians to take responsibility for their own compliance. Every payment that physicians receive, directly or indirectly, will be reported on a publicly searchable website. Unless a physician has the tools to accurately record and track these relationships, he or she could find that they are ill-prepared in the event that questions arise about the work they do. Industry and hospitals will spend hundreds of millions of dollars annually to comply with the Act. Unfortunately, none of these expenditures will necessarily protect a physician.

According to a study published in the Archives of Internal Medicine, only 14% of physicians provided consulting services to industry in 2009, down from 28% in 2004. The study speculates as to potential causes of the decline: press coverage of physician-industry relationships, changing medical school and hospital policies, increased public reporting of consulting relationships, and/or reduced spending by pharmaceutical and medical device companies.

Two years ago, The New York Times told the stories of leading academic scientists, including a cardiologist, a psychologist and an oncologist, who decided to no longer accept paid engagements with industry. One physician explained his decision as "responding to societal pressure." He noted that he is less willing to collaborate on treatments now that receives no pay for spending weekends on advisory boards, and he concluded "I resent the fact that I had to make this decision."

Several physicians told Primacea of similar feelings: all missed contributing their ideas and experiences to the process of advancing medicine. So why did they reduce or stop consulting? Overwhelmed by changing laws and rules, many concluded that continuing industry engagement wasn't worth the risk to their careers and reputations. Others feared being the next subject of an investigation or newspaper article. One even declined to accept royalties legitimately earned on a breakthrough invention.

Concerned physicians acknowledge that a number of physicians were improperly retained and compensated at times in the past. To the extent that the reduction in physician consulting is due to industry eliminating such inappropriate hiring, these recent changes are positive. However, to the extent that these changes primarily reduce productive physician-industry interactions, more appropriate regulations need to be developed.

Conversations with leading physicians lead me to conclude that the vast majority of the decline in physician-industry interaction can be traced to two concerns: public suspicion about physician motives in working with industry and personal fear about conforming to complex and changing legal, regulatory and institutional requirements. More research is required to better understand this issue from the perspective of physicians.

We must reverse the decline in collaborations between physicians and medical companies. Three things must happen so that physicians may continue their critical role in advancing patient care (as has been acknowledged by physician and industry leaders and is nearly universally accepted). First, the value of such collaborations must be more broadly appreciated. Second, a consensus must be formed as to what constitutes appropriate interactions. Third, processes for certifying ethical collaborations must be instituted.

A landmark study of medical journal disclosures found that authors failed to report half of their financial relationships with industry. Conducted at Columbia University's Center on Medicine as a Profession and published in the Archives of Internal Medicine, the study compared disclosures in journal articles with physician payment data from five orthopedic device companies:

Our findings indicate that current journal disclosure policies do not yield complete or consistent information regarding industry payments. More than half of the articles in our sample failed to acknowledge an authors' relationship to a company. In no article could readers know how substantial the company payment to an author was. More stringent journal policies were not associated with greater transparency. Although prominent authorship position and article-payment relatedness were associated with increased disclosure, nondisclosure rates remained high: even when the recipient of company funds was the first, sole, or senior author, only 54% of the articles mentioned the company tie. Similarly, even among articles directly or indirectly related to payments, the disclosure rate was only 50%.

Omissions, misinterpretations and errors in compliance reporting by a number of physicians have led to protracted investigations and a negative impact on public trust. Now that an increasing number of drug and device companies are disclosing payments to physicians—and with the Physician Payment Sunshine reporting provisions of the new healthcare law taking effect March 31, 2013—comparing physician disclosures and industry disclosures will be much easier.

It is easy to predict many more such comparisons.

The availability of industry disclosures of physician payments leads the study authors to conclude that there is "an unprecedented opportunity for the medical profession to move to a system of full, verifiable transparency."

It occurred to us that other medical organizations might also take advantage of company disclosure data. Academic medical centers might use company-supplied data to supplement faculty's conflict of interest statements. Pharmacy and therapeutics committees, as well as other purchasing bodies, might use these data in reviewing members' disclosures. So too, professional medical associations might also refer to company data to examine disclosures by officers, directors, and members who help develop educational activities or formulate clinical guidelines. Finally, governmental bodies might compare these data with the disclosure statements of advisory committee members, study group members, and intramural and extramural researchers.

Physicians are required to provide conflict of interest disclosures to universities, hospitals, journals and medical associations; many of these disclosures have unique formats and requirements.

Get ready for audits to accompany physician disclosures. Physicians now have two choices: (i) Proactively work to develop a disclosure system that more accurately describes their relationships with industry or (ii) do nothing and live with the very negative consequences that arise from flunking.