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A Dark Cloud Still Lingers Over Sunshine Act

April 3, 2015
By

George Orwell, the inventor of the Ministry of Truth, could not have coined a more biting and sarcastic title than the Sunshine Act.

With the advance of the Affordable Care Act the Physician Payments Sunshine Act (now known as Open Payments) could certainly create a dark cloud over every physician who accepted any funding, even a cup of coffee, from Big Pharma or medical device companies; the sun would no longer shine over doctors who made thousands of dollars by giving talks for $2,000 a night in some expensive local restaurant, in front of physicians who ingested both the propaganda as well as a fine meal. Of course, everyone would be able to continue business as usual, but now every penny would be recorded in a database accessible to anyone who wanted to review it.

It’s no secret in the medical community that some physicians write prescriptions for very pricey medications, often because they also receive very expensive meals and even additional remuneration. Take a look at the physicians who are top prescribers of drugs like Bystolic, Ranexa, or Crestor and you’ll find that many also took money from the companies Forrest Laboratories, Gilead, and AstraZeneca.

The Sunshine Act perhaps should have been called the Transparency Act as all it truly does is let the public know who their doctor works for or accepts gifts from.  Want to know why your doctor gave you a drug like Bystolic for blood pressure control — a drug that may cost you as much as $1,200 a year — while the latest Joint National Committee (JNC 8) guidelines tells your doctor to use a better drug that would likely cost under $48 a year?  You may be surprised that he received some form of remuneration from its manufacturer — Forrest Laboratories. Again, this is what the Sunshine Act helps us understand.

But the Sunshine act also reports the most trivial of gifts; like a cup of coffee, I did not request, and yet appeared, without invitation, on my desk a few months ago.  It was brought there, apparently, by a person who worked for Zoll, a manufacturer trying to convince every cardiologist that many of their patients should receive a defibrillator vest… even if there’s no randomized trial yet to show whether it helps the patient or not.  The cost of the vest — around $10,000 for a three month rental — would make the designers of Gucci or Versace flinch.

But to get back to the Sunshine Act, if you go to the Center for Medicare and Medicaid Services (CMS) database and check out my data you will find that I accepted roughly four dollars from Zoll, even if I never asked for that cup of coffee and I asked the Zoll rep to leave my office and never return.

The de facto managers of our healthcare system, the physicians who sit on the panels, who make the rules, and who also make a lot of money, seemed to be in favor of the Sunshine act, and some, no doubt, because the act had one very important exception: Continuing Medical Education talks and seminars.

In 2013, Dr. Steven Nissen, an outspoken critic of our healthcare system and chairman of the Department of Cardiovascular Medicine, at the Cleveland Clinic, and an early champion of eliminating possible conflicts of interest due to physician payments from industry[*], wrote this in a publication of the American College of Cardiology: “No patient should worry that we have placed our relationship with drug or device makers ahead of the needs of our patient’s. Accordingly, the best approach to the Sunshine Act is to ‘just say no’ to invitations to give marketing talks on behalf of industry. Certified CME activities are exempt from disclosure, so we can still educate our colleagues through this less problematic mechanism.  We should embrace the Sunshine Act, not fear it.“

Dr. Nissen’s embrace of the Sunshine Act and its omission of some CME courses, even when they are sponsored by big Industry, troubles me.  While I agree with Dr. Nissen on many issues, and I applaud much of what he says about the Sunshine Act, I cannot condone the exemption of  CME payments to physicians who also take money from the medical industry. IF we are worried about industry influencing physicians to use their product shouldn’t we be more concerned about the funding of a respected “top doctor” who can influence thousands of physicians at an industry-funded online conference, than a single practicing physician that accepts a cup of coffee from a pharmaceutical rep?  Is Doctor Nissen suggesting that the most powerful physicians are inherently honest while the average practitioner is not?

To make it clear, not just anyone can create a CME course. According to the American Medical Association, “In order to certify educational activities an organization must be an accredited CME provider. Organizations may be accredited by either the Accreditation Council for Continuing Medical Education (ACCME) or a recognized state medical society. Activities certified for AMA PRA credit must meet both the AMA’s and the accreditor’s requirements.”

I’ve taken part in many CME activities, some not sponsored by industry, others partially or fully funded by Pharma. And it is often quite clear to me that in general, speakers who accept some form of remuneration from industry present a very biased view. At the beginning of each lecture, they are required to disclose through a quick flash of a slide, whom they have taken money from.

In many CME courses that are ultimately funded by Big Pharma, an intermediary corporation like, for example, Rockpointe, works with the physicans and industry. On their web site Rockpointe claims they are “a science-based medical education company whose clinical specialists, educators, and producers are dedicated to the design and implementation of integrated, certified educational initiatives that are engaging and clinically relevant to health care professionals.“

But from my interviews with physicians who got paid for preparing a CME course and who worked with Rockpointe it appears that Rockpointe aids these doctors in preparing the course, with dollars given to Rockpointe from Big Pharma and that some of the doctors felt pressured by Rockpointe representatives to mention the drug manufactured by that pharmaceutical company.  What’s even more troubling is that doctors who prepared the CME course were paid by Rockpointe. It’s hard not to notice the similarities to a form of money laundering scheme, and the doctors were told they did not have to declare in their talk or on their resume that they ever accepted funds from that pharmaceutical company: Industry to Rockpointe to the doctor!

In July of 2014, the walls of the ivory tower, for the richest and most powerful physicians seemed to develop a few cracks: CMS proposed to remove the CME exemption completely. Now these elite doctors would also just have to “say no” when approached by the health industry with buckets of cash.

What’s good for the goose is good for the gander?  Of course not!  Immediately after CMS announced they would remove this exemption the major medical societies, headed by those rich and famous doctors, began to protest.  Each major society pressured CMS as well as their elected officials to immediately rescind this “horrible” change.

According to the American Medical Association, “On August 5, over 100 medical societies including the American Medical Association (AMA) wrote a letter to CMS.” It read in part:

Our organizations believe that this raises concerns as industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications, or through their physician-employees’ participation in CE [continuing education] activities (either as speakers/faculty or attendees). Our organizations are concerned that this would have a significant, chilling impact on CE, which runs contrary to the public interest.

On November 3, 2014, CMS released “a Final Rule redefining most CME payments as outside of the scope of the Sunshine Act’s reporting requirements.”

I like the idea of the Sunshine Act, although I find the name of it a bit Orwellian. The Sunshine act should try and prevent huge quantities of business dollars from manipulating physicians to over utilize and overprescribe devices and drugs.  But this act fails to do this by allowing the richest and most influential doctors to still secretly collect from their cash cow. That’s a conflict of interest. I believe it is imperative that payments to physicians taking part in CME courses be included in the Sunshine Act while trivial gifts, such as a donut or cup of coffee should remain exempt.

The marring of the Sunshine Act, I suspect by the greedy powerful elites in my profession, is a clear example of the lack of independent leadership in our healthcare system.

So for now if a pharmaceutical salesperson drops off a donut at my office it may be disclosed in the Open Payments (CMS Sunshine Act) database; however, the “top“ doctor who got paid $500,000 dollars for doing CME talks sponsored by Pharma will be exempt. This type of decision making and leadership reminds me of a failing democracy where the powerful and rich manipulate the rules to ensure they are exempt . Whether it’s tax exemptions for the ultra-rich or Sunshine Act exemptions for the rich and powerful physicians, it’s too often about greed and power and selfishness.

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[*] According to online sources Dr. Nissen donates all personal and business honoraria directly to charity.

 

About the author: Evan S. Levine, MD FACC, is Director of the Cardiovascular Center at Saint Joseph’s Hospital and a Clinical Assistant Professor of Medicine at Montefiore Medical Center – Albert Einstein College of Medicine. He is also the author of the book “What Your Doctor Won’t (or can’t) Tell You”. He lives in Connecticut with his wife and children.

 

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4 Responses to A Dark Cloud Still Lingers Over Sunshine Act

  1. heartdude on April 23, 2015 at 4:07 pm

    Thank you for your very appropriate responses.

    Regards,

    Evan S. Levine

  2. politicaljunkie on April 17, 2015 at 3:05 pm

    Wait until we get a Republican president. The cronyism will come back with a vengeance (if it ever really left) and the FDA will return to the mode of operation it was in under Reagan/Bush/Clinton/Bush. That is, corporate profits over human health and safety.

  3. Bill Weaton on April 5, 2015 at 11:42 pm

    Calvin Coolidge said “the business of the American people is business.” However big of an asshole you might think Coolidge was, he was right. But that is the bad news. Business dominates the US and it will get its way in most cases one way or another. The mountains of cash available to pharmaceutical corporations to make campaign donation will almost always guarantee that there is a loophole of some kind somewhere in every law.

  4. jamese on April 5, 2015 at 12:50 am

    A loophole for the powerful or rich? Sounds like America. The Sunshine Act is a step in the right direction – a big one. It’s yet another benefit of Obamacare that isn’t getting much recognition in the press. Yes, there is still a crack in the law that industry is using. Until the American people are honestly informed and stand up against this kind of corruption, it’ll be nearly impossible to get rid of all of it. John Oliver did a segment on pharmaceutical marketing and the sleazy techniques they use. It’s at: https://www.youtube.com/watch?v=YQZ2UeOTO3I.

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