How much sunshine is just the right amount?

Screen Shot 2013-08-23 at 7.12.01 AMThis morning 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 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. (Think Multaq.)

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.

JMM

5 comments

  1. John,

    It is nice to see some sunshine placed on The Sunshine Act. I appreciate your reasoned approach and agree completely with your basic premises.

    I do wish to comment on your statements as they pertain to my world of ICDs. You state: “Overly broad guidelines for ICD implantation led to widespread irrational exuberance for ICDs.”

    As I see it, the guidelines were and remain appropriate. They grew out of the solid evidence base of SCD-HeFT and MADIT 2 trials. We can argue about technical issues of these trials and the overall cost effectiveness, but the premise that we can identify a high risk population and save lives with ICDs has not been disproven. The problem of “irrational exuberance” grew out of the fact that doctors chose to ignore the guidelines and place devices in the wrong patients. It’s pretty clear, too, that absent, shoddy, or coercive counseling led to uninformed implants. It was the doctors, not the data or guidelines, that was the problem.

    I was one of many in the EP community that opposed the policy to extend the implant certification to those without specialized EP training. This policy, however, was designed at its onset to sunset over a few years. It was felt that this would allow experience non-EP pacemaker implanters to begin to implant ICDs. In the future, new implanters would then come out of traditional training programs. The program was not “shut down,” it was designed to end gracefully.

    I have no doubt that perverse incentives have driven some ICD implants, just as they have in every other type of procedural based medicine. I do think, though, that EP device community has been a leader at setting down the evidence base clearly before promoting expensive procedures. That’s more than you can say about a lot of fields, such as interventional cardiology (and, dare I say it — Afib ablation??!!).

    Thanks,

    Jay
    @EJSMD

  2. Thoughts from a patient perspective
    There is much that can be said on this topic. I’ll try to keep it short. It won’t be. The first thing that popped out at me was the burrito statement in your blog:
    “Do we really want the industry responsible for innovative medical products blowing money on keeping spreadsheets of how many free burritos someone is getting?”
    Actually, buffet meals at a conference and anything less than $10 is excluded. There are many exclusions to the reporting, including discounts, samples, and educational materials:
    “•Certified and accredited CME.
    •Buffet meals, snacks, soft drinks, or coffee generally available to all participants of large-scale conference or similar large-scale events.
    •Product samples that are not intended to be sold and are intended for patient use.
    •Educational materials that directly benefit patients or are intended for patient use. CMS narrowly interpreted this exemption. Textbooks and reprints are not excluded under this provision.
    •The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
    •Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
    •A transfer of anything of value to a physician when the physician is a patient and not acting in his or her professional capacity as a physician.
    •Discounts (including rebates).
    •In-kind items used for the provision of charity care.
    •A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund.
    •In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan.
    •In the case of a physician who is a licensed non-medical professional, a transfer of anything of value to the physician if the transfer is payment solely for the non-medical professional services of such licensed non-medical professional. For example, payments to a physician who is licensed to practice law and who is retained by a manufacturer to provide legal advice would not be subject to reporting.
    •In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the physician with respect to a civil or criminal action or an administrative proceeding.
    •A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the manufacturer during the calendar year exceeds $100, subject to increase each year using the consumer price index.”
    http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page
    So, the low end stuff is really is not being reported. BTW, if I were a doctor, I would be insulted if someone thought I would be swayed by a burrito. Anything else SHOULD be reported from a patient perspective. And if the company is paying for and writing off anything else, I guess they can pay for and write off the cost of accounting required by the government.
    What DOES concern me is that people are already blogging about which doctors received payments from drug or device companies to make their argument that the particular drug/device is “bad” and that the doctor who was given something of value for their participation cannot be trusted. A good example is the battles on the afib forums concerning Coumadin/Warfarin and the new novel anticoagulants (namely Pradaxa). The criticism centers around who was paid by BI. I don’t agree with the villainization. Further, reaction from patients in the blogosphere is that they are irritated by prescription pads and pens that say Prozac and yet they are glad to take the free samples as prescription starters.
    Personally, I believe government is too involved in everything and that too many people today either don’t understand, don’t believe in, and/or don’t see the benefit of capitalism and free enterprise. On the other hand, I think the reporting is a good thing. But I’m keeping one eye on the medical companies and my “good eye” on the government.

  3. Dr. Mandrola,

    Good article, though I’m not completely sure that your medical society is immune to having to report physician payments. As a patient advocacy organization, grants from industry stipulate that we must report any payment to a physician to do anything, such as review materials or speak at a program. No one seems immune.

    Mellanie

  4. As a heart attack survivor who takes a fistful of meds every day, I have no clue which of my drugs have been prescribed for me based on flawed industry-biased research or tainted journal articles. And worse, neither do my doctors.

    This reality makes me cranky when docs start publicly bafflegabbing over the Sunshine Act. The simple reality is that this wouldn’t be happening had too many docs not been lining up at the industry trough for far too long. And even when politely asked to disclose financial conflicts of interests in the past, some have been curiously close-mouthed. For the sake of clarity, let’s just call this “lying”.

    My favourite example of this was a 2009 NEJM report following a U.S. Justice investigation into five companies who manufacture hip and knee implants. The companies agreed, in order to avoid facing legal action, to publicly disclose about $270 million worth of kickbacks they’d made to orthopedic surgeons. Researchers then asked the surgeons on the list if they’d ever received cash payments from these companies, and they compared the two lists.

    Well, it appears some orthopedic surgeons have trouble answering simple questions like: “Did you or did you not ever take cash from any of these five companies?” One third of the physicians questioned did not disclose their cash payments, even knowing that the payments had already been made public.

    Patients are justifiably alarmed over growing evidence of an overwhelming and pervasive trend toward this marketing-based medicine. Documented cases of fraud, unnecessary procedures, deadly drugs, recalled devices, retracted journal articles, and cardiologists sentenced to prison terms: where will it end, and why aren’t all decent doctors screaming blue murder over those who are complicit rather than shuffling their feet defensively over the Sunshine Act?

    Device and drug companies don’t spend billions in marketing (twice their R&D budgets) out of the goodness of their corporate hearts. They pay docs because it works to move the product. And no more industry-funded pizza lunch at echo conferences won’t stop the echo conferences from happening.

  5. Great article. Now if only politicians of both parties were held to the same standards as physicians….

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