COMMENTARY

Shedding Light on the Sunshine Act

Frank J. Veith, MD

Disclosures

September 20, 2012

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Hi. I'm Frank Veith, Professor of Vascular Surgery at New York University and the Cleveland Clinic. Today I am going to talk to you about the Sunshine Act -- what's wrong with it and how it can be fixed.

ObamaCare and the Affordable Care Act have the laudable goal of extending healthcare insurance coverage and reducing overall healthcare costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many that are yet unrecognized, that will have detrimental effects on our national economy, multiple parts of the healthcare industry, and most medical practitioners. One of the most onerous aspects of the Affordable Care Act is the Sunshine provision, which is intended to bring transparency to any and all financial relationships between industry and physicians.

The Sunshine Act mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after 2013, published in detail on the Internet. These disclosures must include pens, thumb drives, and meals as well as grants for research, travel to present data at meetings, and consultant fees for proctoring cases in which new devices are used by physicians who are unfamiliar with them.

On the face of it, governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care that is unnecessary or harmful to patients and that the government and taxpayers are largely paying the bill. Moreover, there have been a few flagrant abuses of the industry/doctor financial relationship in which conflicts of interest have risen to the level of gross commercialization, with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by scientific evidence.

Therefore, the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one. Don't be fooled. The specifics of the Sunshine Act are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal. It is also reasonable that physicians be compensated fairly for the time spent away from their practice when providing consultant services, participating in educational activities, or conducting industry-sponsored research, some of which produce valid and important scientific data that are unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such a meritorious activity together with excessive financial awards for unjustified promotional activity, as the Sunshine Act will do, is totally unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services, just as are all other professionals in every other profession. In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious recordkeeping and documentation of miniscule details. This plus the implication of taint will discourage relationships between industry and physicians, which will have many detrimental effects on medical education and, more importantly, on US medical innovation.

The latter is already lagging far behind other parts of the developed world because of stringent Food and Drug Administration requirements. All of these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the US public at large.

There are 2 possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of the reporting requirement with several modifications. The requirement of reporting small and trivial items like pens, thumb drives, and meals should be eliminated. Reporting of only substantial sums in excess of $10,000 should be required. This would markedly decrease the administrative burden of the Sunshine reporting. Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum but be qualified by the time involved and the type of service rendered. Just because a physician received a large payment does not mean that it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, and time commitment are rewarded financially, and this should be the case for the industry/doctor relationship as well.

A second solution to fix the Sunshine Act and make it fair is to apply all of its provisions to members of Congress and all other elected and nonelected employees of our federal government. After all, just like medical practitioners and those in the healthcare industry, our federal officials' and employees' actions affect the well-being of our society, and all of these individuals in government are paid by taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest. Thus, the Sunshine Act should be fixed. More importantly, the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests. If these 2 corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Thank you.

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