Are we about to reach a point where increased transparency and regulation become counterproductive to the best practice of medicine?

Transparency ensures best practice

Charles M. Zacks

A recently reinvigorated look at the ethics of industry-physician relationships has been driven by a confluence of factors — not only higher profile scrutiny by the government and the public, but also the shared long-term goals of both industry and medicine. Despite the obvious mutual potential for short-term gain, in the long run, physicians, medical industries and patients will benefit from maximal truthfulness and integrity in the research and development of quality products. In the interest of fostering that integrity, both physician and industry associations currently self-regulate to a substantial degree and also submit to reasonable external regulation to promote public trust. Transparency and regulation (both external and self-imposed) are means to keep public trust and will therefore contribute to the best practice of medicine.

Clearly, industry-physician relationships are intended to serve a legitimate purpose in advancing patient care technology. Industry benefits from physicians’ expertise to bring good products to market, and experts are entitled to recognition and reasonable compensation for their contributions. However, because most will acknowledge that the potential for bias in these arrangements exists despite the best intentions, public reporting about them is essential. Reasonably detailed public reporting gives a practitioner information from which they might independently evaluate the reliability and integrity of clinical reports, peer-reviewed publications, continuing education materials and presentations. Without this information, the practitioner is in the dark about whether clinical innovations are recommended as a consequence of completely objective and evidence-based inquiry or whether they potentially serve other undisclosed agendas.

Charles M. Zacks, MD, is chairman of the American Academy of Ophthalmology’s Ethics Committee and in practice at Maine Eye Center.

Disclosures may boost public knowledge, perception

Nicole Liffrig Molife

The proposed Physician Payments Sunshine Act, if enacted, will require pharmaceutical and medical device manufacturers to report to the government certain payments made to physicians. The reported information is to be made available to the public through an Internet Web site.

It is important that any disclosed information be made available in a readily accessible manner for patients to benefit in a meaningful way from the required disclosures. Patients are increasingly becoming active participants in their medical care and consumers of health care. Many patients research their medications and review published quality information about providers, such as Hospital Compare or Nursing Home maintained by the Centers for Medicare and Medicaid, before selecting a provider.

It remains to be seen whether patients will actually consider this conflict of interest and financial information when selecting a physician or agreeing to a particular treatment plan. The more likely outcome of the proposed Physicians Payments Sunshine Act and similar efforts to improve transparency is that they will help improve the public’s knowledge and perception of pharmaceutical and medical device industries’ financial relationships with physicians and conflicts of interest that may arise. The fact that the disclosures are being made, whether or not the patients actually review and consider the information, may go a long way.

Nicole Liffrig Molife, JD, is an attorney in the Washington. D.C.-based law firm Arnold & Porter LLP.