By Steven E. Nissen, MD

Close collaboration between physicians and industry is essential for medical progress. We can only develop new therapies that benefit patients when we work together with pharmaceutical and medical device companies to advance the science of medicine. However, physician-industry relationships do not always benefit society. Often, there exists a blurry line between activities that promote public welfare and commercial considerations.

Realizing the marketing value of peer-to-peer interactions, 2 decades ago industry began paying increasingly large sums to physicians to promote drugs and medical devices. These payments created divided loyalties, resulting in an inherent conflict between the physician's duty to his or her patients and their obligations to serve a financial benefactor. Unfortunately, most of these payments were never publicly disclosed.

A Call for Transparency and Integrity

The magnitude of payments to physicians and their impact on our profession has been extraordinary and seem to be increasing. A series of high-profile federal prosecutions have led to court settlements resulting in fines totaling billions of dollars. Most of these out-of-court settlements include "corporate integrity agreements" requiring companies to disclose individual payments to physicians.

These legally-mandated public disclosures are cataloged by the public interest journalism group Propublica on a website aptly named "Dollars for Docs."¹ Such agreements now cover 15 companies representing a 47% market share within the pharmaceutical industry. The total payments reported on the Propublica website have now reached a staggering $2.1 billion. Some individual physicians receive enormous sums of money for marketing drugs, including 22 physicians who have earned more than $500,000 each during the past few years.²

During the last decade, increasing public attention has focused on the complex and pervasive financial relationships between physicians and industry. Direct monetary payments from pharmaceutical and device companies to physicians for promotional speaking have received the most scrutiny, because lawmakers and regulators believe that such payments are most likely to influence prescribing practices.

There is ample reason for concern. Available evidence suggests that the financial relationships between industry and physicians strongly influence physician behavior. A joint project sponsored by National Public Radio and Propublica analyzed Medicare prescribing data and found financial ties between the top prescribers of brand-name products and drug-makers.³ Amazingly, 17 of the top 20 prescribers of the expensive branded ß-blocker, nebivolol, received money from the drugmaker, Forest Laboratories. A single physician wrote more than 2,500 prescriptions for nebivolol in 2010.

Academic excellence and integrity do not seem to be criteria for selection as a promotional speaker. In Georgia, an appeals court upheld a hospital's decision to remove a physician from its staff.⁴ The anesthesiologist admitted giving young female patients rectal and vaginal examinations without documenting why. During a recent year, this physician was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June 2010.

Shining a Light on Physician-Industry Relationships

In the face of these kinds of abuses, Congress finally acted, passing the Physician Payments Sunshine Act as part of the Affordable Care Act of 2009 (signed into law on March 23, 2010). Physicians should be aware of the key timelines and milestones related to implementation of the Sunshine Act. Beginning August 1, 2013, manufacturers of drugs, medical devices, and biological agents must collect and track monetary payments and items of value of $10 or more provided to physicians and teaching hospitals. Some types of payments are exempt. These exemptions are carefully described on a website maintained by the American Medical Association.⁵

Before March 31, 2014, companies must report payment data to the Center for Medicare Services (CMS). Sometime in early 2014 physicians will be invited to sign up to receive notice of the disclosures submitted under their name. Current rules will allow these physicians access to their own data sometime between April and August 2014 (for 45 days only) so that they can challenge inaccurate information. Then, on September 30, 2014, all of the data will be publicly disclosed via a CMS website.

Will the Sunshine Act completely eliminate the perverse effect of industry payments on our profession? Of course not. Disclosure alone does not guarantee integrity, but it is an essential first step. In recent years, medical journals and CME providers have required conflict of interest disclosures, resulting in improved awareness of the potential effects of such payments on objectivity. Patients deserve the same consideration. It is important for physicians to be aware that some patients will undoubtedly scrutinize our disclosures on the CMS website. If we choose an expensive branded product over a generic drug or implant a pricey medical device, patients may be concerned whether our financial involvement unduly influenced our medical decisions.

No patient should worry that we have placed our relationship with drug or device makers ahead the needs of our patient's needs. Accordingly, the best approach to the Sunshine Act is to "just say no" to invitations to give marketing talks on behalf of industry. Certified CME activities are exempt from disclosure, so we can still educate our colleagues through this less problematic mechanism. We should embrace the Sunshine Act, not fear it. The legendary Supreme Court Justice Louis Brandie said it best, noting "sunlight is the best disinfectant."

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References

1. "How Industry Dollars Reach Your Doctors." http://projects.propublica.org/docdollars/
2. "Dollars for Docs: The Top Earners." http://www.propublica.org/article/dollars-for-docs-the-top-earners
3. "Top Medicare Prescribers Rake In Speaking Fees From Drugmakers." http://www.propublica.org/article/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers
4. "Docs on Pharma Payroll Have Blemished Records, Limited Credentials." http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records
5. Resources for Physician Financial Transparency Reports (Sunshine Act). https://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page

Steven E. Nissen, MD, is chair of the Department of Cardiovascular Medicine at the Cleveland Clinic and co-author of Heart411: The Only Guide to Heart Health You'll Ever Need.

Keywords: Physicians, Drug Industry, Sunlight, Marketing, Awareness, Hospitals, Teaching

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