Ethics and disclosure rules: Regulating human behavior?

Issue: March 2006

Douglas W. Jackson [photo] --- Douglas W. Jackson, Chief Medical Editor

The medical meetings we attend and the medical journals we read have become more zealous in identifying and eliminating perceived financial interests in the content they present. They, along with some governmental agencies, the Accreditation Council for Continuing Medical Education and many of our professional organizations are trying hard to maintain public trust. These information providers and overseers want to ensure that the audience gets only fair and balanced scientific information not tilted by commercial interests.

I became more aware of how far this effort has progressed when planning our recent annual Orthopedics Today New York weekend course, all arranged in accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support. I had to show, in writing, that all the planners, teachers and authors involved in developing the CME content disclosed to the accredited provider their “relevant financial relationships.” Those were defined as whether “he or she (or spouse/partner) has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the CME activity content over which the individual has control. These relevant financial relationships must be disclosed to the activity audience.”

Industry’s role

This effort to completely eliminate any conflict of financial interest comes at a time when more than half of current orthopedic research receives industry funding. The fact is, the data generated from this clinically oriented research are often of more interest to the clinician attending courses and reading medical journals then investigations at the molecular level (usually receiving a greater percentage of federal funding). Federal and industry funds flow not only directly to investigators but also make up a very important source of support for their labs, staff and institutions.

Even the National Institutes of Health (NIH), funded heavily by our government, has recently appeared in the news regarding regulations now being imposed on some of the world’s top medical scientists. NIH Director Elias Zerhouni announced the new ethics rules in response to Congress’ and watchdog groups’ concerns over perceived conflicts of interest related to “lucrative outside activities.” These rules are designed to prevent NIH employees from consulting with, or owning stock in, pharmaceutical and biotechnology companies. One NIH scientist, quoted in the Wall Street Journal, told of having to sell his shares in General Electric (GE) because it has a medical imaging division.

Smarter rules?

This, to me, carries the idea of “conflicts” to the extreme. Owning shares of GE is similar to owning a mutual fund. The diversity and huge size of GE’s holdings make it difficult to see how one individual scientist-stockholder could have any influence on price changes. Some aspects of the new rules aggravate outstanding researchers and teachers who sought out NIH for its environment of intellectual freedom and prefer to live by their own personal ethical standards. Certainly, these new rules have much broader implications then the GE stock example suggests, and have evolved in reaction to specific abuses. But the GE example illustrates just how overreaching some aspects of imposed ethics and rules can become.

The recent problems with the cases (Vioxx) that were excluded from the data published in a leading medical journal got widespread media coverage, highlighting this area of commercial conflict. Many now call for more regulation and rules for human behavior. Protecting us has now become part of our learning and education environment. Just look at its impact. At the American Academy of Orthopaedic Surgeons annual meeting this month in Chicago, watch for all the disclosures about receiving something of value from some entity related, directly or indirectly, to a given presentation. These include disclosures related to research funds received by the investigator or their institution, for non-income support, royalties, stock and stock options, or for consultation or employee relationships. For many speakers discussing new technologies, such listings will stretch much longer then academic or scientific qualifications.

Personal discretion counts

Do we need it all? Does it help us tell the difference between “a huckster,” someone selling something, and someone giving their in-depth unbiased experience and research?

It has always bothered me when someone vigorously imposes his or her ethics and rules of behavior on me.

Money isn’t everything

“Monetary conflicts” are the most easily monitored, yet often pose no more of a potential problem in influencing and manipulating the investigator's data than their ego, personal promotion designs, self-aggrandizement and other non-monetary reasons (eg, employment promotions). We need look no further than the recently, widely publicized example of such problems in Korea in the field of stem cell research to make the point.

The potential for overregulation of intellectual freedom, and for holding all entrepreneurial effort suspect, concerns me. I prefer more often than not to hear from faculty with perceived conflicts in which they are disclosed, and then have them explain their thinking and experience in depth.

We want to be careful not to eliminate the “doers” from our educational forums. You have heard it often said, “those who can, do, and those who cannot, teach.” There is a corollary: “Those who are doing it and making it happen are often the best teachers.”