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and medical interests collide
Members of the academic and medical technology communities met at Stanford during the summer to grapple with the thorny questions that arise when monetary and medical interests collide. The session was sponsored by Stanford Medical Device Network, the California Healthcare Institute and the School of Medicine.
Four panelists - including Eugene Bauer, outgoing vice president of Stanford University Medical Center; Thomas Fogarty, professor of vascular surgery; Joseph Martin, dean of Harvard Medical School; and Alan Milstein, attorney with the firm of Sherman, Silverstein, Kohl, Rose & Podolosky - discussed the hypothetical case of a talented physician who holds equity in a company marketing a potentially life-saving medical device that he designed. In the scenario, the researcher's university also holds equity in the company and both will profit if a newly initiated multicenter clinical trial leads to FDA approval of the device. Is it appropriate for the doctor to implant the device in the trial's first patient? And should he and his institution oversee the nationwide trial? Or is it unrealistic and foolish to couple potential financial gain with such responsibility and autonomy?
Panelists agreed that the patient's health should be the highest priority in such situations. But they didn't always agree on how to ensure that the patient receives the best available treatment.
For example, Bauer suggested that for reasons of patient safety, the equity-holding doctor should perform the first procedure and then attempt to export his knowledge and skills to other physicians his department who don't hold equity.
Should the doctor be the trial's principal investigator? Bauer said yes, but Martin - who agreed the doctor should perform the initial procedures - said the PI should be a faculty member from another department. Fogarty said that no third person should interfere with the relationship between the doctor and the patient, and he emphasized that physicians naturally hold the welfare of their patients sacred.
