New disclosure requirements could have some unintended consequences
Misinterpreted data is ethical concern
If a patient finds out her doctor prescribed a medication manufactured by a drug company he happens to have a lucrative consulting contract with, will she view this as an indication that he's prominent in his field — or that he has "sold out" to the industry?
It likely depends on how the relationship is disclosed by the patient's physician, says Eric G. Campbell, PhD, professor of medicine at Harvard Medical School and director of research at Mongan Institute for Health Policy, both in Boston, MA.
Physicians will soon find themselves having many more discussions about financial relationships with patients, he predicts. "We are going to continue to see more and more disclosure of relationships between physicians and companies. The days of hiding these things are over," says Campbell. "What used to be a well-hidden secret in medicine will now be on the web for all the world to see."
The major effect of the Physician Payment Sunshine Act, part of the Patient Protection and Affordable Care Act, which requires manufacturers to submit a list of physicians and teaching hospitals who received any transfer of value of $10 or more, will be to "divert immense resources from research and development into regulatory compliance," predicts Thomas P. Stossel, MD, American Cancer Society Professor of Medicine at Harvard Medical School and director of the Translational Medicine Unit and Center for Medical Innovation at Brigham & Women's Hospital, both in Boston.
"This effect will be most harmful to smaller companies on the cutting edge of innovation," says Stossel. "The obsession with particular financial conflicts is an artifact of instigators who make a career out of 'corruption hunting.' They almost never find it, defined as physicians committing harmful acts."
Here are some ethical concerns regarding public disclosures to be required by the Physician Payment Sunshine Law:
• Physicians might be unnecessarily disqualified from educational meetings and advisory committees because disclosures are misinterpreted.
"This concern has been raised as a reason why so many positions on FDA [Food & Drug Administration] advisory committees are unfilled, even though there are studies which suggest that voting is not necessarily biased by having general relationships with the pharmaceutical industry," says Richard Payne, MD, Esther Colliflower Professor of Medicine and Divinity at Duke University in Durham, NC.
A 2011 study looked at 463 retracted publications and found that commercial sponsorship was not linked to an increased risk for withdrawal of manuscripts due to fraud or plagiarism.1 A 2006 study found that excluding FDA advisory committee members who had conflicts would not have altered the overall vote in any meeting that was studied.2
"If there is no evidence of corrupt behavior, then what are we really after here? It's the appearance of corruption," says Lance K. Stell, PhD, FACFE, Thatcher Professor of Philosophy and director of the Medical Humanities Program at Davidson (NC) College and clinical professor of medicine at Carolinas Medical Center in Charlotte, NC.
"We have 25 years of a rising chorus of claims that doctors dealing with industry are corrupt," says Stell. "A lot of it is based on survey research and people's perceptions. But when you look at the data, there is not much there."
Michael A. Weber, MD, professor of medicine at the State University of New York Downstate College of Medicine in Brooklyn, NY, argues that the term "conflict of interest" itself is misleading, since it implies the benefits of an activity must be offset by some sort of negative outcome.
"'Multiplicity' of interests or 'alignment' of interests seem more appropriate where the intention is that all those involved will benefit in some way," says Weber.
• Physicians might be deterred from participating in legitimate research and educational activities.
The implementation rules for the database called for under the Sunshine Act have been delayed several times due to concerns about the possible negative effects of the reporting requirements, notes Stell.
"There are serious concerns that research will be deterred, legitimate continuing medical education will be undermined, and that people will avoid activities that will put them on the Sunshine list," he says. Campbell says physicians should avoid certain kinds of medical education events that are primarily focused on marketing of pharmaceuticals, and that this is particularly important for academic physicians.
"Doctors should not be part-time drug salesmen," he says. "The mission of academic health centers is to provide patient care and educate the next generation. I'm not aware of a single one that has selling drugs as part of their mission."
• The institution might benefit from the relationships as well by getting a share of the income generated by the activities and an increased flow of fee-paying patients.
Thus, the need for ethical conduct must be shared equally by the physician and the hospital, argues Campbell.
"In the end, the only protection for patients, either in the hospital or in an office setting, is the professional integrity of those providing the care," he says. "This should be covered by the well-established ethical precepts of medical practice that have been in place for many years."
• Disclosures might discourage innovative activities that could result in better, but potentially more expensive therapies.
"It's understandable that agencies wish to keep a lid on spending," says Campbell. "But the Sunshine Act is clearly intended to serve a financial agenda, rather than a clinical or humanitarian one."
The law will discourage many physicians from collaborating with industry, according to Stossel. "Little or no evidence supports that conflict-of-interest management has accomplished anything else except eating up time and financial resources," he says. "To the extent that institutions embrace it, it is for avoidance of any publicity."
Role of bioethics
Disclosure is only one small part of the management process of conflict of interest, argues Payne. "We need to better prepare and educate patients about what to do with the advice, and to not fall into the trap of necessarily being more trusting of the doctor simply because they have disclosed," he says.
It is the responsibility of institutions and organizations to build processes that can monitor and check these matters, says Payne.
There are no data on how well academic health centers actively enforce the rules they have regarding relationships with industry, says Campbell, and these might not be consistently enforced.
"The perception has always been that if you are a superstar in the field and found to have inappropriate or unreported relationships, that by and large, not much is going to happen to you," he says. "You might get a slap on the wrist, but that's not the case with junior faculty."
The public needs to be educated that some relationships exist essentially to market drugs, while others are necessary in terms of medical education, Campbell says. "Not all of them are good and should be allowed to continue, and not all are bad and ought to be stopped," he says.
Physicians practicing in rural areas might rely on drug representatives to keep their knowledge up to date, Campbell acknowledges, "but I would argue from an ethical perspective, that if teaching hospitals and medical schools are unable to appropriately educate their medical students, residents, and physicians without drug company help, they should get out of the business."
Bioethicists should be the group that leads the debate about what kinds of relationships are appropriate and which are not, suggests Campbell.
"Too often, debates about this are very polarized, with pro-industry and anti-industry people," he says. "The role of the ethics community could be to hammer home the idea that these relationships are not universally bad and they are not universally good. They have risks and benefits."
References
- Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: A systematic, controlled, retrospective study. Current Medical Research and Opinion 2011;27(6):1175-1182.
- Lurie P, Almeida C, Stine N, et al. Financial conflict of interest disclosure and voting patterns at Food and Drug Administration drug advisory committee meetings. Journal of the American Medical Association 2006;295:1921-1928.
Sources
- Eric G. Campbell, PhD, Professor of Medicine/Harvard Medical School/Director of Research, Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA. Phone: (617) 726-5213. E-mail: [email protected].
- Lance K. Stell, PhD, FACFE, Thatcher Professor of Philosophy/Director, Medical Humanities Program, Davidson (NC) College. Phone: (704) 894-2482. E-mail: [email protected].
- Richard Payne, MD, Esther Colliflower Professor of Medicine and Divinity, Duke University, Durham, NC. Phone: (919) 660-3572. E-mail: [email protected].
- Thomas P. Stossel, MD, American Cancer Society Professor of Medicine, Harvard Medical School/Senior Physician, Hematology Division, Brigham & Women's Hospital, Boston, MA. Phone: (617) 355-9001. E-mail: [email protected].
- Michael A. Weber, MD, Professor of Medicine, State University of New York Downstate College of Medicine, Brooklyn, NY. Phone: (212) 584-9191. E-mail: [email protected].
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