Tuesday, July 11, 2006

Widespread Conflicts of Interest at Stanford: Defining Deviance Down?

The San Joses Mercury News just published a major series of investigative reports about conflicts of interest at the Stanford University School of Medicine, written by Paul Jacobs. In three articles published Sunday (How Profits, Research Mix at Stanford; Federal Rules Often Go Unenforced; and How We Did This Series), Jacobs describes the scope of conflicts of interest at the Medical School.

First, for an overview:
• The school's 700-plus faculty members last year disclosed 299 potential conflicts of interest related to their research, according to figures provided by Stanford.

• Potential conflicts occur throughout the school's ranks. More than a third of the school's administrators, department heads and other leaders -- at least 26 out of 67 reviewed by the Mercury News -- have reported outside financial interests related to their research within the last four years. These are scientists who are role models for junior faculty members and graduate students.
• Perhaps most important, seven of the 10 members of the school's conflicts of interest committee, which is responsible for enforcing the rules, have financial relationships with medical companies. Unlike a comparable committee at the University of California-San Francisco, Stanford's panel includes no outside volunteers.

And here are some telling anecdotes:

One researcher has founded six companies, most based on research that came out of his own lab. He is a managing partner of a venture capital firm focused on medical research and sits on the boards of several other companies. His role at the venture company was approved by the dean several years ago because he has no day-to-day management responsibilities. The researcher is a member of the school's conflict of interest committee.

One senior associate dean started a biotech company based on her federally sponsored lab work.

And the physician who until January chaired the department of gynecology and obstetrics is a longtime director of Wyeth, which manufactures controversial hormone replacement therapy for women -- therapy she defended in 2002 when potentially serious health risks were emerging.

Note that this information was not easy to obtain. Jacobs wrote:

To get information for this series, the Mercury News:

• Obtained correspondence between the university and the National Institutes of Health for the past five years under the federal Freedom of Information Act.

• Searched medical journals, most of which require authors to disclose any conflicts when they publish an article, and disclosures accompanying speeches given at medical conferences.

• Reviewed corporate news releases and other documents filed with the Securities and Exchange Commission, which frequently list information about faculty members who are company founders, directors or scientific advisers.
Stanford's main response to conflicts of interest is to require disclosure, and if necessary, management.

Stanford medical school has a 10-member conflict of interest committee, created in 2001 to oversee how substantial conflicts that exceed certain thresholds are handled. All faculty members are required to disclose their financial relationships at least once a year. Those reports go to the school's conflicts manager, who determines which cases must go to the committee.

The committee does its work in secret.
Stanford admininstrators defended the University's approach to conflicts of interest. For example,

'I'm not really sure where this wild West idea came from,' said Dr. Harry B. Greenberg, a senior associate dean for research. 'Very early on, Stanford has been associated with a lot of entrepreneurial activity and people may have equated the ability to carry out entrepreneurial activity with lack of oversight and regulation. I really don't think that has been the case.'

[However,] Greenberg holds stock options in and is a consultant to MedImmune, which makes an influenza vaccine he is studying under a federal grant.

However, despite rules requiring prompt reporting of substantial conflicts, Stanford failed to report six grants to NIH until after the Mercury News asked NIH and Stanford earlier this year for documentation of conflicts. Med school spokesman Costello said the failure was an administrative error and that all the scientists followed Stanford's disclosure rules.

One of those six grants involves Greenberg, a senior associate dean for research and chairman of the school's conflict of interest committee.

Greenberg is an expert on vaccines. In late 2000, he took a two-year leave from Stanford to become vice president of research at Aviron, now MedImmune Vaccines, where he helped develop the Mountain View company's nasal flu vaccine, FluMist. While there, he made the case for FDA approval of FluMist to the agency's vaccine advisory committee, which he had chaired just nine months before.

Today, Greenberg remains a paid member of MedImmune's scientific advisory board and holds stock options issued while he was employed by Aviron. He said the options are ``still underwater,'' meaning that exercising them would cost him more than the stock is currently worth. ``I had a great time at Aviron, but becoming filthy rich was not part of it, unfortunately,'' he said.

He is also one of three Stanford scientists now working on a federal grant to compare MedImmune's FluMist vaccine and Fluzone, a more traditional, injectable vaccine from Aventis Pasteur. Both vaccines have been approved by the FDA and are commercially available.

The principal investigator on the NIH-funded grant, which was worth $3.1 million last year, is Dr. Ann Arvin, the Stanford-wide associate dean for research -- a position with responsibility for faculty conflict of interest issues across the university.

For the past several years, she, like Greenberg, has been a paid member of MedImmune's scientific advisory board and holds stock options in the company.

The husband of a third researcher, Dr. Elizabeth Mellins, was vice president for clinical research at MedImmune Vaccines and helped bring FluMist to market. Mellins says she has no direct involvement in the clinical trial.
I will let the reader be the judge of how convincing Greenberg's defense of how Standford handles conflicts of interest is. Some are skeptical, though.

'There is a focus on procedural solutions and this magical belief that disclosure is the answer as opposed to dealing with the fact that many of these things should not be allowed,' said Barbara A. Koenig, a bioethics researcher at the Mayo Clinic and former executive director of Stanford's Center for Biomedical Ethics.

Tufts University Professor Sheldon Krimsky, author of 'Science in the Private Interest,' argues that fields such as law have stricter conflict policies than universities. A judge, for instance, isn't allowed to have any financial relationship with a party that might benefit from a ruling.

But is disclosure enough? Being on a corporate board of directors, for example, carries a legal responsibility that can clash with the interests of students and patients, said Dr. Roy Poses, who runs the non-profit Foundation for Integrity and Responsibility in Medicine. [That's you - ed. I know.]

'I am quite surprised that there seem to be many leaders in academic medicine, who also simultaneously have clear responsibilities to protect the interests of corporations and stockholders,' he said.
As the man said, read the whole thing.

My comments, in addition to the one above, are that this is yet another demonstration about how pervasive conflicts of interest have become in health care in general, and in academic medicine in particular. While conflicts have become so pervasive, individuals with conflicts may seem to blithely disregard any possible downside to such relationships. Thus, this seems to be an example of defining down deviance.

In my humble opinion, however, such pervasive conflicts threaten the core mission of academic medicine. If substantial numbers of faculty and administrators have major financial entanglements with outside organizations whose goals are to sell products or services (or to promote ideologies or belief systems, for that matter), how can one trust the medical school or academic medical center to provide unbiased, disinterested teaching, research, and patient care?

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