Scientific integrity is the theme of the Greek tragedies that currently involve two of America’s most prestigious physicians. Both men worked for decades to reach the pinnacle of the medical profession; now both are brought low.
The first of the dramatis personae is 81 year-old Dr. Sidney Gilman, Chairman of Neurology at the University of Michigan for over a quarter of a century from 1977 to 2004. A former professor at Harvard and Columbia, and past president of the American Neurological Society, he authored hundreds of scientific papers, served on the editorial boards of key medical journals, and was a consultant to the FDA and several major pharmaceutical firms. Nearing the end of his chairmanship at Michigan, he was honored with the establishment of a neurology service at the university hospital and an annual lecture series, both named for him.
Recently Dr. Gilman found himself in a quite different role - key Government witness in federal court. In a huge Wall Street insider trading trial, he admitted providing confidential inside information about a new drug under development for Alzheimer’s disease to the hedge fund portfolio manager who is the defendant in the trial. The hedge fund company realized over a quarter-billion dollars from the information.
As chairman of the safety monitoring committee testing the Alzheimer’s drug, Dr. Gilman was scheduled to present the study results at a scientific conference in Chicago. Twelve days before the conference, he deliberately leaked the results to the portfolio manager. The resulting stock transaction, and the relationship between Dr. Gilman and the defendant, attracted the attention of the Securities and Exchange Commission. The SEC subsequently indicted the manager and filed a complaint against Dr. Gilman. In exchange for avoiding prosecution, Dr. Gilman agreed to cooperate with the SEC investigation, testify in the current trial, and pay nearly $250,000. The affair forced him to resign his position at Michigan.
Wayne State University law professor Peter Henning said the doctor may have been naïve when savvy, big money Wall Street investors befriended him. Henning told the Ann Arbor Observer, “I don’t believe he thought through the consequences of his actions, what a black mark they would leave on his career. I mean, this is going to be what’s in the first paragraph of his obituary… at one point he looked at the man in the mirror and convinced himself he wasn’t doing anything all that wrong.”
The second protagonist, in a separate case, is Dr. Charles Denham, a leader in the patient safety movement that has become the centerpiece of American medicine. Dr. Denham’s credentials are impeccable: he is a member of the President’s Circle of the National Academies of Science and Editor-in-Chief of The Journal of Patient Safety, and associated with the Harvard School of Public Health and Mayo Clinic College of Medicine. He has chaired the Safe Practices Program of the Leapfrog Group, a consortium of Fortune 500 companies with billions of dollars in healthcare purchasing power. The required reading periodical for all healthcare executives, Modern Healthcare, has named him one of America’s 50 Most Powerful Physician Executives several times.
His name also came up in the legal world recently. The Justice Department accused a healthcare company, CareFusion Corp., of paying Dr. Denham $11.6 million in kickbacks while he served as co-chair of a committee of the nonprofit National Quality Forum, which makes national practice recommendations on patient safety.
The Justice Department alleged the payments were meant to promote sales of a preoperative skin preparation and market it for unapproved uses, in violation of the federal False Claims Act. In a pubic statement a Justice Department spokesman said, “Corrupting the standard-setting process through kickbacks can affect the healthcare treatment choices that doctors and hospitals may make for patients.” Dr. Denham, facing no charges, admitted being paid the money but disagreed with the characterization of “kickback”. CareFusion has agreed to pay $40.1 million to resolve the allegations.
The medical community has been less than vigorous about policing these types of conflicts of interest. It strongly abjures trivial situations like pharmaceutical companies providing lunch for low-paid medical residents and students. Yet there is a remarkably laissez-faire attitude toward the potential bias of prominent physicians doing research for pharmaceutical firms or developing important nationwide medical guidelines, which may involve millions or even billions of dollars.
A top university research physician recently confided to me that it is fairly common for physicians involved in drug trials and clinical guideline development to have significant conflicts of interest. Yet the prevailing belief is that the value of their expertise outweighs any bias they might bring to their science. Furthermore, scrutiny by the medical profession is supposed to guarantee against outside agendas. Even politicians are held to a higher standard than that.
Every Greek tragedy has its Chorus. In these particular cases, it is the late physicist Richard Feynman, one of the great scientists of the 20th Century and an avatar of scientific integrity. Feynman, a Nobel Prize winner, was the man who demonstrated the cause of the space shuttle Challenger explosion in a simple experiment on national television, and was highly critical of the intellectual honesty of many involved in the project. He continually emphasized that scientific integrity is a principle of scientific thought that demands utmost honesty—in essence, leaning over backwards intellectually to be honest. The Gilman and Denham cases suggest that in today’s medical environment, this approach is in jeopardy.
Forty years ago, giving the Caltech commencement address, Feynmann made a timeless observation about scientific integrity, “The first principle is that you must not fool yourself—and you are the easiest person to fool. So you have to be very careful about that.”
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