Will the United States maintain its position as a world leader in medical technology?

A CLOSER LOOK AT CONFLICT: ONE WAY NOT TO GO

AAMC’s ‘rebuttable presumption’ policy does not serve patients

The Association of American Medical Colleges (AAMC) is a group of academic institutions that helps to define policy for the conduct of research in academic medicine. A few years ago an AAMC task force came out with a policy for the oversight of financial interests in clinical research, which states the following: “Institutional policies should establish the rebuttable presumption that an individual who holds a significant financial interest in research involving human subjects may not conduct such research.”²

This “rebuttable presumption” policy, which establishes the premise of guilt until innocence can be proven, is decidedly un-American. Although patient harm or other abuses can occur when a physician performs clinical research using devices, procedures, or drugs in which he has a financial stake, such abuses are quite rare in my experience. This AAMC policy is not in the best interest of patients because it insists that innovators recuse themselves from research that involves the very technology in which they are the ones who are most expert and knowledgeable. As a result, patients who are candidates for a new procedure or a procedure that uses a new device will not be able to undergo the operation at the hands of the most capable person but must be sent to another surgeon. This is the case even if the patients are referred to the innovator by their own personal physician and even if another independent surgeon agrees that the proposed procedure makes sense.

The only party whose interest is served by this ridiculous policy is the institution, as the goal is to prevent potential adverse publicity. In this, too, the policy is misguided, since bad publicity for an institution can come from cases involving new procedures and old procedures alike.

Conflicts must be accepted and managed

The AAMC has come out with a related policy maintaining that conflicts of interest among researchers are to be avoided at all costs. I take that to mean that researchers are supposed to just die, since conflicts of interest are inherent in our existence and represent a critical element in all relationships. It is true that most routine daily conflicts are not serious, but to deny conflicts when they exist serves no useful purpose. We have conflicts and we have to learn how to manage them, consistent with protecting the interests of individuals. In the case of physicians, these individuals are our patients.

THE NECESSARY WORK OF DEFYING CONSENSUS

Much of what is done in health care—developing rules and regulations; issuing recommendations, standards, and guidelines; working to increase compliance—is aimed at creating order and consensus. While a certain degree of order and consensus is necessary, of course, these are not the factors needed to spur improvements and advances. Improvement requires people who are willing to challenge, who will defy consensus and tell us what we are doing that is not so good.

This is the natural tendency of the inventor and the innovator—to go against the grain, to go outside the standard of care and do something that is new, that is not in compliance, and that may or may not be accepted. This is why, in my view, it takes more courage than brains to be an innovator. No one likes to be ridiculed or to be told that they are not in compliance and are perhaps endangering patients’ lives. Of course, inventors and innovators often do not help themselves in this regard, as they tend to be odd ducks by nature and do not always express themselves well. Still, their function of defying consensus is necessary to virtually all medical progress.

A WAKE-UP CALL FOR INNOVATION IN AMERICA

I will conclude by returning to my broad topic of whether the United States will maintain its preeminence in medical technology. As I said at the outset, I cannot answer that question in the affirmative, largely because of the breakdown in cooperation and collaboration among practitioners, academia, and industry for the reasons I have outlined above.

The signs of our waning preeminence cannot be missed. The manufacturing of medical technologies is going offshore, with significant economic implications. More importantly, clinical studies are now increasingly moving offshore. I was recently involved in 9 months of offshore clinical studies to collect the necessary data to submit a device for US approval, because the studies were prohibited from being performed in the United States. Despite this prohibition, it is these offshore studies that reveal any deficiencies in the technologies being assessed and that allow those deficiencies to be corrected for the benefit of US patients. And US patients themselves are increasingly going offshore for medical care—either to obtain medications or to undergo procedures that involve a device that cannot be used in the United States.

As a result of the above developments, significant investment is going offshore, taking with it a great deal of interest in innovation. Meanwhile, that interest in innovation is decreasing in the United States because it is being deterred, delayed, and encumbered by overregulation. This practice is not in the best interest of our economy and certainly not in the best interest of patients in this country, and not enough people are aware of this considerable problem.

I will be happy to take questions from the audience.