How misplaced zeal might kill significant medical innovation
Medical companies often solicit opinions and assistance from physicians when developing products. Who better to ask? It's not surprising that surgeons provide valuable insight for designing new tools, hospital equipment, and pharmaceuticals. And because companies ask busy physicians to take time away from successful practices, it's not unusual for doctors to accept payment for their effort. And therein lies the rub.
The ethical dilemmas in this collaboration comes when physicians do not disclose to patients, firms, and schools that the devices or procedures they might recommend came from their own involvement, and that they were paid for helping develop them. In this suspicious world, little minds jump to the worst conclusion: The doctors are up to something.
The topic of disclosure (payments) and collaboration came up at the last AdvaMed conference. The ensuing discussion showed the subject has many shades of gray, and then some. For instance, panelist and CIMIT founder John Parrish remarked that the issue is charged and complicated.
Stanford University cardiologist Paul Yock told of how a local newspaper raised clouds of suspicion after running stories on the proliferation of ties between medical companies and Stanford that enriched the school's bank accounts. Revelations of physician payments made doctors' motives appear suspicious. This led to an identity crisis at the institution, says Yock, which had prided itself on its many innovations and felt it was above such a fray.
To alleviate perceived conflicts of interest, members of Congress, ethics panels, and medical-company advocate groups such as AdvaMed promote the Physician Payment Sunshine Act of 2008. If passed, it will require full disclosures of financial transactions between industry and physicians.
That sounds quite reasonable. Ziyad Hijazi, an AdvaMed panelist and cardiologist at Rush University Medical Center, Chicago, says doctors there must report payments of over $10,000. The disclosures have not hampered research. Most patients who are asked to participate in studies consent because they are interested in good outcomes, he says, and tend not to ask about financial details.
What's more, funding is limited, especially at universities and hospitals. Hijazi says such facilities lack the money to fund his research. And doctors who apply for NIH grants might discover that the agency is not interested in their research. The recent financial crisis will only exacerbate things. That leaves many research physicians with nowhere to turn but industry.
This ethics issue gets stickier when the latest research collides with desperate needs. Hijazi tells of a 16-year-old with a history of cardiac problems. After two open-heart surgeries, the teenager needed yet another to replace a failing valve. A third such surgery was not a good idea. Alternatives were death, or a more recently developed valve that could be inserted in a minimally invasive manner. Hijazi discovered the valve while collaborating with a heart-valve company, but the valve lacked FDA approval. Hijazi says he initiated the approval steps but the go-ahead only came after four months of hard negotiations with the FDA and recommendations from an independent panel of cardiac surgeons at the Cleveland Clinic. That was in 2005. Since then, Hijazi says, the boy has graduated from high school and is living a normal life. So who profited most from this collaboration?
All five panelists agree that disclosure of payments is a good idea. But beware of how easy it is to cast doubt on the motives of a professional. If there is an ethical issue in these cases, it always relates to decisions regarding how to best treat the patient.
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© 2012 Penton Media Inc.
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