This post was authored by Steven E. Nissen, MD, MACC, a past president of the ACC and chair of the Department of Cardiovascular Medicine at the Cleveland Clinic.

Collaboration between physicians and industry is essential for medical progress. We can only develop new therapies that benefit patients when we work together 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.

As a result of government lawsuits, some companies are required to disclosures payments to physicians. These disclosures are cataloged on the website Dollars for Docs by the journalism group Propublica. Such agreements now cover 15 companies representing a 47 percent market share within the pharmaceutical industry. The total payments reported on the 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.

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.

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.

Before March 31, 2014, companies must report payment data to the Center for Medicare Services (CMS). 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.

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. However, certified CME activities are exempt from disclosure.

We should embrace the Sunshine Act, not fear it!

*A version of this article also ran in the August issue of CardioSource WorldNews. Watch a recent ACC webinar to learn more about how the new law will impact physicians.

< Back to Listings