ARTICLE IN BRIEF
Physicians and legal experts question whether the new sunshine law, which mandates that pharmaceutical companies publicly disclose their financial contributions to physicians and researchers, promotes enough transparency about potential conflicts of interest.
A new law requires pharmaceutical and medical device companies to publicly disclose payments made to doctors, whether it's money for research, continuing medical education (CME), or informational sessions.
Some doctors hoped the new law, which was included as part of the sweeping health reform legislation that passed in March, would allow patients to become more informed and the profession as a whole to be more transparent. But they said the bill was far from perfect because it excluded pharmacists, nurses, and nurse practitioners. And representatives from the pharmaceutical lobby worried that the information would be overwhelming and confusing.
Commonly known as the Physician Payment Sunshine Provision, the section also requires companies to release information made to physicians and academic medical centers about drug samples, meals, and travel.
“There is a lot of money spent on health care, and we need to trust the basic science that goes into it,” said Joseph Ross, MD, an assistant professor of medicine at Mount Sinai Medical Center who studies conflict of interest issues in the medical field.
“What I'm hoping with all this new legislation is that the practice of working together changes, and that it's less about marketing and sales and more about physicians working with industry to work and develop better products.”
THE PUBLIC DATABASE
Many states have had disclosure laws for several years, starting with Minnesota in 1993 and Vermont in 2001. Several states, including Massachusetts, Colorado, and Connecticut recently enacted similar laws. A recent study of Vermont's pharmaceutical disclosure law shows that companies have been particularly generous to four specialty groups, including psychiatry, endocrinology/diabetes/metabolism, internal medicine, and neurology.
The federal law requires companies to begin recording payments in 2012. A public database, coordinated by the US Department of Heath and Human Services, is expected to be online by September 2013.
Manufacturers are already posting information. Last summer, Eli Lilly began posting a “Faculty Registry Report” online that details its payments to doctors and educators as well as whether the payment was for patient education, heath care professional education, or consulting. Companies also submitted documents to Congress detailing drug sample practices, including 39 million samples worth about $356 million by Merck & Co., according to a Wall Street Journal report.
Michael A. Williams, MD, medical director of the Berman Brain & Spine Institute at Sinai Hospital of Baltimore, said disclosing the information will only reinforce that the relationships between physicians and industry be above board.
When Dr. Williams gives talks, he always makes a conflict of interest disclosure, including the companies he works with, and asks the audience to inform him if they feel there is any commercial bias in his presentation.
“People can debate whether the actual amount should be disclosed, and people can make the case that support of $100 is different from $100,000,” said Dr. Williams, who formerly served as the chair of the AAN Ethics, Law, and Humanities Committee. “That may or may not be true, but disclosure serves both the public and medicine well.”
Dr. Williams said that he remembers when doctors routinely went on junkets and accepted gifts, but that doctors, academic centers, and the pharmaceutical industry itself have backed off from those practices.
Marjorie Powell, senior assistant general council to the Pharmaceutical Research and Manufacturers of America, the lobbying arm of the pharmaceutical industry, said the industry initially supported the federal statute, but had concerns about the amount of information released. The federal version did not pre-empt state reports, and some states might collect different information than the federal database, which could result in multiple sites for information.
“I live in Maryland and my doctors have offices in Maryland, Virginia, and DC, and there could be different reports available depending on whether I'm looking at the DC information or national information for the same doctor,” Powell said.
She said pharmaceutical interest is only one of a number of influences on doctor prescribing practices, including what the insurance companies pay for and what their peers do. Disclosing the information could be burdensome for doctors, as they try to explain to patients what they do and why they do it.
In some cases, pharmaceutical companies work with doctors to improve products, she said, and if consulting payments are reported as gifts, it could be discouraging to physicians.
Timothy Jost, who teaches health law at the Washington & Lee University School of Law, worked on Conflict of Interest in Medical Research, Education, and Practice, the 2009 report from the Institute of Medicine. He said the federal database should improve relationships within the pharmaceutical industry and with patients.
“People will be able to search the database, so if your doctor says he wants to implant an artificial hip and recommends a specific one, you can see if he's getting payments from the manufacturer,” he said. “ I think these payments might taper off some if they are publically disclosed — doctors might not be as willing to take payments if they're disclosed.”
Part of the issue is simply letting the public know about the payments, he said. That way it would foster debate about the very existence of the relationship. The IOM study recommended that there be a complete end to gifts for doctors and medical students. They also called for a consensus process to develop a new system for financing CME free from industry influence.
Medical schools are already moving in that direction, as the University of Michigan Medical School decided in June not to take any money from drug or medical device companies to pay for CME.
The next step, said Dr. Ross, who is moving from Mount Sinai to Yale Medical School, would be to include nurses, pharmacists, and nurse practitioners in the database.
“Many nurse practitioners write prescriptions and they're the first line in less urban areas,” he said. “And pharmacists play a big role. They often sit on hospital boards for formulary decisions.”
INFORMATION FOR THE PUBLIC
Jost said the point is not to put physicians on the spot, but to provide information to the public. Dr. Williams added that it doesn't bother him when patients do ask him questions.
“Even when I give talks to patient advocacy groups for patients and families, I disclose my conflicts of interest, and most of them say ‘Well, that's OK,’” he said. “But some people ask ‘Does it make you blind to other treatments?' which means they understand the heart of the issue: Does a conflict of interest cause a physician consciously or unconsciously to make decisions they wouldn't make otherwise. The AAN Code of Professional Conduct concisely states, ‘Whenever a conflict of interest arises, the neurologist must attempt to resolve it in the best interest of the patient.’”
“In scientific publications and in teaching, the harm comes in not disclosing — it's not the conflict, but the ‘cover up,’” he said. “If physicians are honest and open about their conflicts of interest, then they put the tools into the hands of other people to decide if the conflict is significant.”