Society has clearly benefited from the partnership between the pharmaceutical and medical device industries. For more than 100 years there has been an unwritten understanding that industry, working in a market economy, would develop those treatments that physicians and their patients require, while the government would supervise the approval process, as well as regulate the marketing and manufacturing of drugs and devices.
However, through the years, questions have been raised about potential conflicts of interest related to relationships between physicians and industry that could bias prescribing patterns, which would adversely affect health care costs. Therefore, as part of the Patient Protection and Affordable Care Act passed by Congress in 2010, a section was added (Physicians Payments Sunshine Act) that requires manufacturers of drugs, devices, and biological or medical supplies to report certain payments or transfer of value, to physicians, other health care workers, and teaching hospitals. Reports have to be made about consulting fees, honoraria, gifts, entertainment, food, travel, and research and speaker payments for continuing medical education.
The regulations regarding the Sunshine Act went into effect in April 2013. In August 2013 data collection began, with reports being made to the Centers for Medicare & Medicaid Services, and in September 2014, the data were released publicly.
Previously, certain states and professional organizations have tried to address the physician–industry relationship by developing codes of ethics and regulations about public reporting of monies paid to physicians. Ultimately, this led to the current federal regulations mandated in the Sunshine Act. I am supportive of a mechanism that can serve to inform society about potential conflicts of interest between industry and physicians by public disclosure. However, whether or not patients will be influenced by the information reported, and whether health care costs will be contained still needs to be seen over time.
However, the data reported to the public still need to be accurate, and then interpreted properly. In this issue of The American Journal of Medicine, Alhamoud and his colleagues6 report on a discrepancy they found between reports made by authors of clinical guidelines and pharmaceutical companies about past payments made. Most probably, this discrepancy was caused by the methodology of reporting. However, this type of problem should be resolved by the Sunshine Act, as long as data are accurately reported by industry concerning what payments are actually made and for what. Also, monies paid through a research grant are different from lunches provided by industry to physicians and their staff, and the public needs to be made aware of this difference.
I have been involved in clinical research for over 40 years working in a medical school/hospital setting, and have been the recipient of many federal and industrial grants for patient studies, which were conducted on almost all of the new cardiovascular drugs introduced since 1972. The funds received for these studies were turned over to the medical school, and were not a direct part of my salary. Today, it might be interpreted, erroneously, through data reported by industry, that as a principal investigator I somehow was benefitting personally, and in my practice, prescribing certain treatments because of it.
Disclosure is an important part of the government–industry–patient–physician partnership, a relationship that has allowed the US to be the leader in new drug and device development for the world. However, the data reported to the public by the government need to be accurate. I predict that will occur, as the regulations included in the Sunshine Act are tested, and then modified over time.
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-William H. Frishman, MD, MACP
This article originally appeared in the January 2016 issue of The American Journal of Medicine.
