Saturday, October 4, 2008

Senator Grassley, Psychiatric Ethics, and Conflict of Interest

Senator Charles Grassley, ranking Republican on the Senate Finance Committee, is on the warpath about conflict of interest in psychiatry.

More power to him. My profession and the public should thank him and his staff.

Senator Grassley and his committee have pursued conflict of interest inquiries for many academic leaders in psychiatry - most recently Dr. Charles Nemeroff, who, until he stepped down this week, was chair of psychiatry at Emory.

In each case the issue is essentially the same: (1) the psychiatrist in question was paid substantial sums by drug companies; (2) the psychiatrist in question wrote, spoke and did research about the company's products; and (3) the psychiatrist's disclosures of the financial arrangements were incomplete at best and, possibly, deliberately inaccurate.

The basic response has been, essentially - "my judgment has not been corrupted, trust me."

This isn't adequate, and neither is disclosure.

For contrast, take an area of psychiatric ethics about which the American Psychiatric Association is unambiguous - "sexual activity with a current or former patient is unethical." Why is this the case?

The most common rationale is that the patient will be harmed. This is probably true almost all the time. But there are well known examples of decades long happy marriages between psychiatrists and former patients. Why don't these examples undermine the absolute ethical prohibition?

The reasons are (1) trust and (2) the ancient roots of the medical profession in religious healing. When we're ill we turn to members of the health professions. As professionals they "profess" basic commitments, most notably, that they will always seek our well-being and will not exploit us. Even if there have been some happy marriages between psychiatrists and former patients, any ambiguity about the attitudes and values on something as basic as having sex with their patients will diminish overall trust in a profession we count on when we're in some of life's toughest moments. Medicine won't work if patients have to wonder if the physical exam is leading to diagnosis and treatment or to sex.

Just so with the revelations about Dr. Nemeroff. Even if his research papers are scientifically impeccable and his clinical recommendations have been unbiased, the revelation that he earned $2.8 million from drug company consultation between 2000 - 2007 (and failed to report at least $1.2 million) undermines the trust the profession needs.

Medicine needs to reformulate the way it manages conflicts of interest. Disclosure is necessary, but it's not sufficient, even if it is done well. (And from Senator Grassley's inquiry we know just how poorly it's actually done.) The expectations will be more complex to articulate than "no sex with current or former patients," but we need better behavioral guidelines as to what is acceptable and what isn't.

(If you want more on this topic, see articles in the New York Times and Wall Street Journal, and Senator Grassley's October 2 letter to Emory. And, see previous posts here and here.)

2 comments:

Myron Pulier said...

Jim Sabin has provided an excellent perspective... but the suggestion that "we need better behavioral guidelines as to what is acceptable and what isn't" leaves something important out.

Search for a solution to the conflict of interest problem should not be limited to judging or restricting the actions of the "conflicted" person. Rules demanding less conflict (such as a cap on an individual's compensation from pharmaceutical companies), greater transparency (more-open disclosure), and fiercer sanctions (enforced standards for manuscript rejection, public reprimand, etc.) might help, but won't suffice.

So-called conflicts of interest are not simply bad; their harmfulness is a matter of degree, and the conflicts can bring advantages to society: for example, big phama sometimes funds a research breakthrough that far outweighs the impact on patients of having biased the researchers. This implies that we need a method for quantifying the actual harm. Conflict of interest in scientific research is often not realistically avoidable... this is different that having sex with a patient, which can reasonably be unequivocally condemned for reasons Jim Sabin has nicely explained.

Part of the question is how best to mitigate (not only how to throttle) conflicts of interest. Frank disclosure is a start, but how can the audience use the disclosure? What will a clinician do with this information? What is a patient to make of it? How can everyone's processing of the disclosure be enhanced to promote clinical outcome and economic efficiency... and other bottom-line results?

Such questions deal with the systems level of the issue and involves a larger perspective than mere focus on "behavioral guidelines" for researchers and teachers.

Jim Sabin said...

Hello Myron -

Thank you for these thoughtful comments!

I agree that conflicts of interest are (a) hard to avoid and (b) "not simply bad." Pharmaceutical company profit motive can lead to breakthrough new products or, at the other extreme, to bribing physicians to use their drugs. Because of the numerous scandals involving suppression of research data and misleading publications, trust in Pharma has gone way down. This leads to knee jerk suspicion of any and all Physician/Pharma links.

I believe that history will conclude that the last 10 - 15 years have reflected the weaknesses of deregulation and excessive greed. We may well swing the pendulum too far in the other direction.

The point of my comparison to patient-doctor sex was that even if the act is not harmful to the individual patient, it harms the profession through diminished trust. Likewise, even if Dr. Nemeroff's work has been entirely unbiased, the way he has handled his financial links to Pharma and his faulty disclosure harm the profession in a similar manner.

I also agree with your conclusion -we need to focus at system level interventions as well as our behavior as individual physicians.

Best

Jim