COMMENTARY

What Lurks in the Shadows of the Sunshine Act?

Henry R. Black, MD

Disclosures

February 09, 2012

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Hi. I'm Dr. Henry Black. I am a Clinical Professor of Internal Medicine at the New York University School of Medicine, a member of the Center for the Prevention of Cardiovascular Disease, and Immediate Past President of the American Society of Hypertension.

Although I agree with many of the things in the Affordable Care Act, one of the things that I think is a real issue is the Sunshine Act. This was added in 2010 and is now going to be a federal mandate. What it means is that everything a device maker or a drug company provides to doctors -- everything from a pen to a pizza to a Post-it, as well as research grants and travel to important meetings to present data -- is now going to be disclosed.

Disclosure itself shouldn't be a problem. I wish Charles Barkley would disclose how much he is getting from Weight Watchers, or Paula Deen would disclose how much she is getting from a company that makes insulin while she is creating recipes that seem to make people more likely to get diabetes, but that is not required right now. We don't know how much Tom Hanks or Brad Pitt get for their movies unless they want to tell us, and it doesn't bother us. What has happened right now is that everything we as physicians get is now going to be disclosed, and has to be disclosed by federal law. This has been the custom, and there are about a dozen drug companies that are already doing this. The questions are, who benefits, who is harmed, and what are the data that the amounts that are transferred to doctors or doctors' practices hurt anybody or hurt outcomes?

There was a study in 2005 that implied that even a small amount, such as a pen, a Post-it, or a pizza, would influence how doctors prescribed. That study has never been validated or repeated, and I think it is unconscionable and an abomination to think that I would prescribe something different for a patient because I had a pen that said whatever it said. I want to give the patient what is best for that patient, and I don't think that that amount of support or that amount of what has been considered bribery is going to make any difference.

The important thing about disclosure is that it used to protect us from people thinking that we were conflicted. Conflict of interest is now a very important thing. Guideline committees have to write guidelines about [drugs or devices from companies] with whom they have no relationship whatsoever. How can somebody who doesn't practice invasive cardiology not have a relationship, to some degree, with the companies that make the devices they use? And how would anybody who doesn't do so have any sense of what is important and what is useful?

This is a key issue right now. The federal Sunshine Act is only going to disclose these things, but the interpretation of those disclosures is important. I have no problem disclosing what I get. In every other facet of business that I know of, the people who get the most are considered the best. Look at the actors or the celebrities or the sports figures. We don't criticize somebody for being successful in their chosen occupation, but somehow, doctors who are considered successful because of the support they get from industry seem to be a problem.

The Sunshine Act is also very important in another way that is a problem. What you get for a research grant on an important product or device is lumped together with what you get in the form of pens, pizzas, and Post-its. It is all put together, but there is a very big difference between an industry-sponsored grant, where you are investigating an important product, and a consultation with a company to see whether what they are doing is right or having a lunch at a particular meeting. Yet, those are all lumped together.

The Bayh-Dole Act that was passed in 1980 was the result of something that began in 1945, when Vannevar Bush, who was President Roosevelt's science advisor, noticed that very few of the devices and patents given to universities ever got commercialized because they were licensed by the government and there was no patent protection. By 1980, it became law that universities had to partner with someone who could commercialize the device. This has made an enormous difference. Think back to what we had to use in cardiovascular medicine in 1964, before Medicare -- how many drugs and devices have been invented, patented, and marketed since then and are saving lives and increasing lifespan.

The Sunshine Act has the real potential of reducing that innovation -- something that we think we need to do, and something the President has said that we need to do. Medical research is very important, and anything we do to constrain it, even psychologically, is a mistake. The Sunshine Act, in my view, is an abomination. Thank you.

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