An important and informed opinion from CMPI Chairman, Dr. Michael Weber.
THE PHYSICIANS SUNSHINE ACT: MORE DARKNESS THAN LIGHT
The New Year brings in its wake the Physicians Sunshine Act and its requirement that pharmaceutical and device companies document all their payments to doctors, medical practices and teaching hospitals so that, starting in 2013, these costs can be listed by the Center for Medicare and Medicaid Services on a public website. This action will result in unintended (but not unforeseeable) consequences on 21st century medical progress.
The Sunshine rules are unclear and complicated – a bad combination. Not only will direct compensation to doctors be reported, but also all other costs of industry-supported physician-related research, consulting and education.
Why this drastic and invasive step? Follow the money. Sunshine supporters hope that physicians, seeing their compensation made public, will curtail their interactions with industry -- thus limiting the development and use of “expensive” new products.
Understandably, government and private health insurers want to keep costs stable. And, with prescription co-pays being patients’ most visible expense, they might find this action appealing -- for a while – until they see how innovation and new treatments are seriously delayed.
Collaborations between physicians and industry are fundamental to advancing medicine. Academic physicians have the experience to identify unmet clinical needs, advise on potential new treatments, design and conduct innovative research and, through publications and teaching, bring key information to colleagues and patients. Without in any way diminishing the governmental and non-profit agencies that support research, it is the partnership between physicians and industry that has created many, if not most, of the major medical breakthroughs that have reduced the rates of death and other serious outcomes in recent years – as any literature search of major medical journals will quickly confirm.
Conducting clinical research has become so rigorous and sophisticated that those of us who serve as consultants and investigators to industry recognize it as a major commitment or even a primary career path. In addition, as studies are completed, physician researchers add to their professional commitment by becoming the teachers of this new information.
Critics of these collaborations see compensation of physicians as evidence of undue influence on medical practice. But doctors, like all professionals, should be paid fairly for their time and work. In reality, industry is now so conscious of not appearing to overpay doctors that they employ stringent “fair value” scales to set fees for research, consulting and teaching activities. The truth is that physicians who are busy with these activities are not as well rewarded as their fellow specialists in full-time clinical practice. Adding to this remunerative divergence is that a key part of research, writing articles for publication, takes weeks of work -- often unpaid so as to avoid any suggestion of bias.
The Sunshine Act will create troubling misconceptions for and about physicians. Payments reported for physicians by industry will likely include funding they didn’t personally receive nor will they take into account costs incurred by these physicians in paying their own staff and covering overhead expenses. Doctors involved in industry-supported research and education may easily get discouraged and frustrated explaining these complexities to an audience already biased and sated by sensationalistic media reports of physicians “on the take.”
And yet the Sunshine Act, paradoxically, could have a positive effect. Despite the near impossibility of reliably interpreting all the reported data, this information might well serve as a yardstick of cooperative achievement --identifying those physicians at the forefront of medical innovation.
Weber, a former president of the American Society of Hypertension is Editor-In-Chief of the Journal of Clinical Hypertension, professor of medicine at SUNY Downstate College of Medicine, Chairman of the Center for Medicine in the Public Interest, and a member of the Association of Clinical Researchers and Educators.
