The Physician Payment Sunshine Act, contained in the Affordable Care Act (ACA), requires pharmaceutical companies and other medical industries to report all direct payments or gifts over $10 that are made to physicians. It is set to take effect in January of 2012.
A recent article, posted by Doctors for America, noted that the Sunshine Provision, by allowing more transparency in physician payments, only offers a reporting system, and does not “in itself change the way physicians do business.”
The article noted that the Sunshine Provision is just “one more indication that both doctors and patients are coming to terms with the complex role that the health care industry plays in shaping medical practice.” The author recognized that “physicians have always had a complex relationship with the health care industries.”
Consequently, the author noted that, understanding this complex relationship “is an important step towards meaningful reform that will hopefully someday include availability of an excellent formulary of generic drugs to all patients, and medical education that is not so expensive that it in itself drives health costs.”
Although somewhat critical of the payments industry makes to physicians, the article recognized that, “the medical advances these companies provide are critical to what physicians do, and physicians need to stay informed of what’s happening.”
Despite recognizing the benefits industry provides, the author took concern with such payments and collaboration because “physicians as a group have been a little slow to admit their susceptibility to corporate marketing.” The author noted that physicians “overarching obligation is to their patients, and when their encounters with manufacturers of pharmaceuticals and medical devices involve receiving gifts, even small ones, communication turns into marketing turns into… conflict of interest.”
This argument is problematic because it assumes that all industry-physician collaboration is problematic and creates a conflict of interest. The author does not take into consideration the positive benefits that come from industry-physician collaboration such as clinical trials, drug treatments, medical education, and advances in many disease areas. Moreover, the author ignores the fact that most of the encounters physicians have with industry today are governed by institutional policies, PhRMA Code of Ethics, AdvaMed Code of Ethics, and many other legal guidance’s from HHS OIG, FDA, and the Department of Justice.
The author, a pediatrician, attempts to substantiate her article by noting that her specialty is not as “marketed” as others because pediatrician’s try to keep their patients off of products. She contrasts her experience with her husband’s, a neurologist, who recently attended a national neurology conference. The author claims that the conference her husband attended included “beautiful women in alluring evening gowns who shucked oysters for the attendees in front of an open bar, compliments of a big-name drug manufacturer.” She added that, “one night they all received free tickets to the Boston symphony from another industry sponsor.”
While provisions of food are generally permissible at such events, the PhRMA Code of Ethics explicitly prohibits gifts of entertainment, so it is unlikely this story is true if in fact this was a recent neurology conference.
The author continues her criticism of industry by claiming that “study after study” has shown that “being the recipient of a gift – even a small one – confers a sense of obligation.” She exacerbates this claim by stating that, “significant data has accumulated to show that gifts subtly shape the prescribing practices and clinical decisions of conscientious physicians in ways that they are completely unaware of. Even gifts as trivial as a pen with a logo or a bag of sandwiches for the medical staff were shown to alter prescribing behaviors.” She does not cite the sources of such data.
Besides being based in social science, the “studies” never measure any impact of such gifts on patient or clinical care. In other words, there has never been any research to show that physician-industry collaboration or payments have harmed patients. Furthermore, no doctor would risk their practice, family or profession over a pen or piece of pizza.
The author also complained about free samples, and claimed that, while the doctor may “be well-intentioned in passing them out, they often cost the patient much more in the long run when the actual prescription is filled.” She went on to assert that a free sample might not be the best choice of medication and that they may have simply been the most convenient to reach for. Accordingly, she maintained that, “free samples are a very effective marketing tool,” and ultimately, a conflict of interest.
However, the author clearly ignores the benefits of free samples and overstates their costs. First, prescription medicines make up only about 10 cents of every dollar spent on health care. Second, drug starters, or samples, provide greater choice and a faster start of treatment – at no cost. By removing free starters, doctors and patients lose yet another avenue for deciding the best treatment.
In fact, if free samples are removed, costs may increase because patients may be more likely to run out of medications or have adverse consequences to medications they were unable to try because samples were unavailable. Moreover, a recent study published in the Journal of the American Medical Association showed that drug therapy actually lowers the overall cost of health care and removing samples would thus reduce this benefit.
Finally, the author takes issue with industry grants used to fund medical conferences. She recognized that, “doctors want to, and in most states are required to, participate in many hours of expensive continuing education.” She noted that, “Industry grants help defray that cost” and “the industry has voluntarily taken measures to remove overt marketing influences from these settings.”
However, she claimed that “more nuanced strategies remain,” such as speakers at sponsored conferences (or “thought-shapers” as they are known in the industry) who offer presentations that, while factually accurate, weigh much more heavily towards treatment than diagnosis and prevention.”
This argument is problematic for a number of reasons. First, the author clearly ignores the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, which govern the use of industry supported education programs and prevent the kind of “nuanced strategies” the author claims to exist. Moreover, the author fails to ignore three very large studies conducted last year, which clearly showed little if any bias in commercially supported CME programs.
Like other industry critics, the author presupposes that any kind of industry funding automatically biases an educational program. This kind of reasoning is misguided and ignores the tremendous benefits of industry-sponsored education. Commercial support of medical education allows new data and information to be disseminated to practitioners in an interactive and timely manner. It means that new clinical data, research, and treatments make their way from the bench to the bedside quicker, saving lives and money.
Ultimately, as professional organizations continue to raise physician awareness on these matters, and doctors become more aware, active, and vocal in the way they manage these relationships, the public and physicians must be skeptical of articles such as this, which only portray the potential negative consequences of physician-industry collaboration.
Today, Americans are living longer, healthier, and happier lives. Americans with AIDS, cancer, diabetes, and heart disease are living longer and surviving, all because of the breakthroughs from industry and the collaboration companies have with physicians and academic medical centers.
The transparency the Sunshine Act will bring to these relationships will be important to ensure that public trust an integrity in our health care system and the life sciences industry is high, but it should not be used to stigmatize the hard work such companies perform to ensure that the next generation of Americans lives longer and healthier.