The Sunshine Act: A chilling effect on medical education?

Recently, I awoke to a picture of myself in the Wall Street Journal. I was asked to comment on the effects of the coming Sunshine Act. Respected health care journalist Peter Loftus found me through social media channels.

What follows are some thoughts about how the Sunshine Act might play out.

Every Thursday during my cardiac fellowship training, at noontime, the entire department gathered for an hour-long conference on echocardiography. Unknown images were shown and trainees took turns getting grilled. Faculty commented from the back of the classroom. There was, shall we say, a spirited tone to the learning.

To this day, 16 years removed from that conference, many of the lessons (and images) remain burned into my memory. There’s something about knowing you are on the hot seat that helps forge long-term memory. Echo conferences at Indiana University were perhaps the most consistently useful hour of my entire medical training.

There was something else at these conferences. There was always an industry sales rep peddling their new drug or device. They brought lunch and gave out logoed pens. But it wasn’t exactly free. The cost was exposure to industry and its bias.

Physician interactions with medical industry have gone on since the advent of modern medicine. All branches of medicine and surgery benefit from innovative developments in pharmaceuticals and devices. I can continue as an electrophysiologist because of an orthopedic device in my shoulder. Expensive high-tech medical devices are central to the practice of heart rhythm medicine. I can ablate atrial fibrillation (AF) in less than two hours now because of medical device innovation. A defibrillator kept a family friend with us for an additional seven years. These devices and important medicines (like antibiotics, clot-busting drugs, anticoagulants, chemotherapy and oodles more) were developed and studied in collaboration with physician scientists. This is necessary and good. You want this.

Humans, however, will always behave like humans. We call this human nature. Inherent in any physician-industry relationship is the possibility of conflict of interest. Financial conflicts can influence scientific investigation, especially in promoting a favorable clinical trial design. Money may bias medical education. Thought leaders who work with industry may be less likely to be critical of a company’s drug or device.

Another problem with industry-physician relationship comes in the formation of practice guidelines. This is really important. The advent of protocol-based medicine, stricter adherence to evidence-based medicine, and quality reporting has heightened the importance of guidelines. In Cardiology for instance, many established treatments call for the use of expensive drugs or devices. Guideline writers therefore have enormous influence of the use of these products.

Take the example of the rollout of prophylactic ICDs about a decade ago. Overly broad guidelines were one of the factors that fostered irrational exuberance for ICDs. Implants were placed in elderly, sick and frail patients. So great was the predicted impact of these devices, medical societies even sanctioned the training of non-electrophysiologists to meet the coming need. (That policy has been reversed.) But I ask you: did industry dollars contribute to such irrational exuberance?

So we have good and bad. We need clinicians to collaborate with medical industry. This will lead to innovative technology that will better mankind. But on the other hand, human nature means conflict of interest will always factor in.

One way to deal with this quandary is with increased transparency. US Supreme Court Justice, Louis Brandeis said, “Sunlight was known to be the best disinfectant.”

The Sunshine Act is a new law aimed at increasing transparency in the way doctors interact with industry. It requires medical device makers and pharmaceutical companies to collect and then report all transfer of value to physicians. This ranges from a sandwich and coffee all the way up to million dollar royalties. The information will eventually become available on a publicly reported website. It will be very detailed. My AF talk this year in Cincinnati and social media talk at Heart Rhythm Society will show up. I didn’t work for free on these.

Patients will know about their doctors’ conflicts. Doctors will know about the conflicts of scientific leaders — an important factor in evaluating medical research. Both patients and doctors may better understand the conflicts of guideline writers. All caregivers will grow more thoughtful about industry interactions. This sort of sunlight is good.

But there are potential downsides of the Sunshine Act.

Doctors are a conservative lot. Concern over perception will surely decrease physicians’ interactions with industry, both the useful and not so useful ones.

Do we really want the industry responsible for innovative medical products blowing money on keeping spreadsheets of how many free burritos someone is getting?

The effect on physician education might suffer. Though the Ben Goldacre’s of the world rightly emphasize bias when industry entwines itself with medical education, I can attest to have learned a lot from industry-sponsored programs — like the echo conferences a decade ago.

And this too. One thing that happens when industry sponsors a learning session is that doctors come to it. They talk; they share cases; they come together face-to-face. Such interactions are critical. Will the disappearance of sponsored sessions decrease the amount of face-to-face learning? Yes it will. Maybe social media can fill the face time void. And maybe not. A chilling effect on physician education should not be minimized.

There is one exception to the Sunshine Act that deserves emphasis. If industry gives money to a medical society as an unrestricted grant, the society can then use the money to pay speakers without disclosure. As long as the money is not ear-marked, no disclosure is required. Influence leaders, therefore, can continue to be paid for influencing. If the ultimate goal of the Sunshine Act is to improve transparency or perhaps even decrease utilization of expensive medical care, this loophole seems an important one.

And the final irony. Deep down, I believe that less is more in medical care. Changing the culture of American medicine from one that disrupts so much to one that disrupts a little less will ultimately improve societal health. Alas, the problem is that it’s all so nuanced. The Sunshine Act may help sharpen some lines, but in the care of other humans, the lines will always remain blurry.

John Mandrola is a cardiologist who blogs at Dr John M.

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  • ninguem

    You’re a handsome devil, John.

  • guest

    not sure why everyone is picking on this article. It’s informative to me that the Sunshine Act which is a waste of time has loopholes so in essence it is yet another waste of taxpayer dollars.

  • bill10526

    The benefits of a new drugs or devices can not be realized until they are used. We have to balance lack of benefits against inappropriate use. With the excessive regulations by the FDA and the post market vigilance, going after hamburgers is absurd.

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