What the Sunshine Act Means for Health Care Transparency
Part of the Afordable Care Act was designed to allow anyone to look up which doctors are getting how much from which companies.
Curious whether a prescription or medical device your doctor is recommending comes from a manufacturer who has been paying your doctor? Good news, then: The federal government has finally developed a plan for how the Physician Payments Sunshine Act will work. The Sunshine Act, made federal law as part of the Affordable Care Act in 2010, was designed to allow anyone -- patients, doctors, journal editors -- to look up which doctors are getting how much from which companies.
Three weeks ago, in an open letter expressing frustration over lack of movement on the Sunshine Act, the former editor-in-chief of the New England Journal of Medicine, Marcia Angell, and four colleagues reminded the White House that financial relationships with drug and device makers are well known to influence physicians' treatment choices and to drive up healthcare costs. Angell and her colleagues called on the Obama administration to "implement the Act without any further delay so that it can begin, as soon as possible, to rein in the undue and harmful influence of money on medicine."
Why would a doctor resist having payments made public? I put that question to Ben Goldacre, physician and author, most recently, of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. Goldacre responded, "I think they're often embarrassed. That in itself is enough to tell you that this is something that needs to be in the open." In fact, Goldacre observed, "academic research has repeatedly shown that doctors who receive money from industry have biased views about which treatment works best."
Goldacre cited the diabetes drug Avandia as a good example of how obscured financial ties can harm patients. Avandia, Goldacre noted, "is now estimated to have caused tens of thousands of heart attacks in the U.S. alone. Concerns had been raised for many years, and the academic literature was divided," meaning that the average doctor might reasonably have been confused from the medical literature as to what to think about the drug. In 2010, a careful analysis of the medical literature showed that, in Goldacre's words, "academics and doctors who said heart attacks weren't a problem were over three times more likely to have received money from the pharmaceutical [industry], and from GSK [the manufacturer] in particular."
Indeed, Howard Brody, a physician and ethicist at the University of Texas Medical Branch-Galveston and author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, suggested in an email interview that "the real goal of Sunshine legislation is to attack the total amount of influence that the pharmaceutical and device industries exercise over medical research," and thus over practice that is based on that research.
Brody argued, "It is hard for a conscientious physician today to learn the truth about which drugs work and how safe they are, even if that physician only reads medical journals and does not ever talk with drug sale reps," sent to their offices by drug makers, "since so many of the articles published in reputable journals have distortions introduced by commercial sponsorship." The problem gets compounded, he said, when practicing physicians are pressured "to adhere to clinical practice guidelines for treating common conditions, and the physicians who sit on those guideline panels often have serious financial conflicts of interest with industry."
Although transparency about financial ties does not "cure" influence, it at least helps us understand it. There may, of course, be legitimate reasons for a physician to be paid by a pharmaceutical company -- for example, for conducting a study -- but watchdogs like Angell, Goldacre, and Brody see no reason why such relationships should be obscured.
While we've been waiting for the Sunshine Act to take effect, piecemeal efforts by non-profit institutions have already resulted in some windows of transparency. The public interest journalism group Pro-Publica has been providing a "Dollars for Doctors" portal that allows users to search payments to individual physicians. Some medical schools have also taken to requiring their faculty to disclose financial ties; for example, my medical school openly publishes who pays each of us -- although not how much. The "Unbranded Doctor" campaign of the National Physicians Alliance has organized a pool of physicians who, in Brody's words, "have taken a principled stance against commercial influence distorting medical practice."
In theory, the Sunshine Act should make it much easier for everyone -- patients, journal editors, physicians, and those assessing guidelines -- to look up payments and gifts to physicians. That said, we can expect pharmaceutical and device makers to quickly invent new survival strategies.
Indeed, it appears from experts' reads of the newly released rules that the feds have cordoned off a whole financial area in which no sun will shine: Comparing the draft rules to those released this past week, Larry Husten of Forbes noticed that the finalized rules allow companies to pay physicians as speakers for Continuing Medical Education (CME) events, "as long as the companies don't select the speakers or directly pay them." But many physicians get ideas about what drugs and devices to use -- or not use -- at such CME events.
On this, Brody observed, "the new regulations apparently support the fiction that so long as the money is properly laundered, the drug company exerts no real influence over the nature of the CME program." But "the simple fact is that drug companies fund CME program support out of their marketing budgets." He added, "They spend the money that way because they expect a payoff in increased prescriptions for their product."
Brody's reading is backed by Ed Silverman, editor of Pharmalot, a website that tracks the pharmaceutical industry. When I asked Silverman about the CME exemption, he replied, "CME providers exist to facilitate the messages propagated by manufacturers." He added, "By deciding disclosure is not warranted, the administration is allowing a form of laundering to be sanctioned."