BY KRISTA CONGER

Dr. Foremost is a talented physician who holds equity in a company marketing a potentially life-saving medical device that he designed. Dr. Foremost'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 Dr. Foremost 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?

Although the situation described above is hypothetical, it mirrors the types of cases popping up with increasing frequency at medical centers around the country. On the evening of July 23, members of the aca-demic and medical technology communities met to grapple with the thorny questions that arise when monetary and medical interests collide. Physicians, academic leaders and government agencies are currently struggling to develop guidelines that acknowledge the potential for conflicts of interest without stifling fertile collaborations between academia and biotechnology.

Four panelists -- including Eugene Bauer, MD, vice president of Stanford University Medical Center; Thomas Fogarty, MD, professor of vascular surgery; Joseph Martin, MD, dean of Harvard Medical School; and Alan Milstein, JD, attorney with the firm of Sherman, Silverstein, Kohl, Rose & Podolosky -- discussed the case. Greg Koski, MD, PhD, director of the Office of Human Research Protection also spoke on the evolving role of government inpatient protection.

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.

"The patient's welfare is the fundamental question,"said Bauer. "It's critical to take into account the technical skills of the person performing the procedure."For this reason, Bauer said, Dr. Foremost -- who is intimately familiar with the device -- should be the one to implant it into the first human patients. After the initial implants, however, Dr. Foremost should attempt to export his knowledge and skills to other physicians in his department who don't have equity in the company, he said.

Bauer added that he believed it would be acceptable for Dr. Foremost to be the principal investigator for a national clinical trial, with appropriate oversight.

Martin agreed that Dr. Foremost should do the initial procedures, but thought the principal investigator should be a faculty member outside of Dr. Foremost's department and that Dr. Foremost should not participate in the design of the trial. Eventually, Martin said, it might be appropriate for the control of the trial to be transferred to another institution.

Fogarty said that no third person should interfere with the relationship between the doctor and the patient, and emphasized that physicians naturally hold the welfare of their patients sacred. He disagreed with Martin's assessment that Dr. Foremost should not be involved in trial design, arguing that Dr. Foremost's previous experience with the device would be invaluable in determining selection criteria for study participants.

Milstein argued that no decision could be made about the appropriateness of Dr. Foremost's participation until the extent of financial involvement and the structure of the clinical trial were fully disclosed.

"Not every financial interest is a conflict of interest,"he said. "It is a conflict of interest when the doctor is making decisions based in part on his own financial interests."

Audience members were also asked to vote on the most appropriate way for the university to handle Dr. Foremost's -- and its own -- potential conflict of interest. Sixty-four votes, 34 of which were cast by medical school faculty or staff members, were tabulated during the seminar. Of the respondents, 37 felt Dr. Foremost should implant the device into the first patient, while 15 said one of Dr. Foremost's colleagues at the same institution should perform the procedure, and that it was permissible for Dr. Foremost to observe and advise, but not physically participate. The remaining 12 respondents felt that either a colleague should perform the procedure alone or that the surgery should be performed by different doctors at a separate institution.

On the question of who should serve as principal investigator for the trial, 29 respondents felt an independent, nonequity-holding colleague of Dr. Foremost's would be the most appropriate person,subject to an oversight committee consisting of uninvolved faculty members to assess scientific merit and conduct. Seventeen thought Dr. Foremost should be the principal investigator, subject to the same oversight committee. Fifteen believed that no one at Dr. Foremost's university should hold the position, and three respondents felt Dr. Foremost's colleague would be a good choice even without an oversight committee.

Most respondents felt the best overall mechanism to address conflicts of interest for faculty members and industry would be a special university committee that includes outside representation.

The forum, which was held in the auditorium of Lucile Packard Children's Hospital, was sponsored by Stanford Medical Device Network, the California Healthcare Institute and the School of Medicine. It was paired with an invitation-only summit on the same topic that took place July 22-23. The summit was co-sponsored by the medical school and the Medical Technology Leadership Forum, a national group that conducts research and education in health policy issues.

The case history of Dr. Foremost was written by Aaron Kaplan, MD, a cardiologist from the Veterans Affairs Palo Alto Health Care System. David Gollaher, PhD, president and CEO of the California Healthcare Institute, moderated the panel. Mildred Cho, PhD, senior research scholar for Stanford's Center for Biomedical Ethics and a specialist in conflict-of-interest management, helped organize the event.