Sunday, June 7, 2009

More on Conflicts of Interest, Devices, and the Value of Innovation

I recently had some e-correspondence with a gentleman who is a vice president of a medical device company. He sent me a published paper of his on medical innovation, and an apparently unpublished commentary on conflict of interest (COI). He seems to be concerned that recent attempts to rein in COI such as the IOM report are overshooting the mark and endangering the future of innovation and discovery through burdensome regulations.

I responded to him at some length and being a lazy sort of individual, reasoned that maybe I could make the response double as a blog posting. I think the general tone of his comments can be discerned from my responses to them and a couple of key quotes contained below, so I'll not reprint any of his original remarks.

It seems clear from the list of recommendations at the end of your manuscript on COI that we agree on a good deal. I also agree with you and always say this when asked to speak on COI, that the device and pharmaceutical industries require different approaches when it comes to the presence of sales reps in the hospital. Devices, for their proper use, need a hands-on demonstration and the ability for hands-on adjustment and modification, that is not true for a pill or capsule. Therefore the trained engineer/device sales rep must assume in role in the hospital, including presence in patient care areas, that would be quite unnecessary and in my view highly improper for a drug rep.

The sentence that struck me as being most in agreement with my own views was, “Second, industry gifts that have no reasonable bearing on innovation, education or the practical elements of commercialization should disappear.”

Where then do we disagree? It would seem that our disagreement resides mostly in the way we define and assess COI. You say correctly that the mere presence of COI should not be presumed to equate to actual misconduct. I interpret this position to be the same as arguing that if we discover that a judge who is deciding a lawsuit between Company A and Company B owns $50,000 worth of stock in Company B, we should not accuse that judge of misconduct. Rather, we need concrete evidence that he ruled differently in the case than he would have, had he owned no stock. It is always possible that a judge of integrity, who owns that much stock, would simply put that consideration out of his mind and rule exactly the same as he would have if he had no financial stake. Absent concrete evidence of misconduct, we should not impugn the judge’s integrity by making any accusations.

Of course, this is not how we actually behave. We expect that a judge who owns stock in one company would recuse himself from the case. Failure to recuse would be seen as a clear instance of judicial misconduct. Why? As I attempt to explain in the chapter in my book, Hooked, on ethical fundamentals, I follow Ed Erde in seeing COI as essentially bound up with the idea of trust in a social role. A person who has a COI is a person who has allowed himself to be placed in a situation where thoughtful observers would worry that he’d be tempted to neglect the interests that he is duty-bound to protect, in favor of some personal interest of his own. This situation renders him less trustworthy in the eyes of those observers. A profession that depends greatly on public trust to be able to carry out its function—such as the judiciary, or medicine—has to be very worried about COI due to the potential for loss of trust.

The serious dangers of loss of public trust in medicine were especially brought home to me recently in discussions with a colleague here in pediatrics who is an expert on childhood immunization, and who is very worried about the potential for major outbreaks of infectious disease due to the large number of unimmunized children in some communities. This is directly attributable to the rise of celebrity “experts” and associated websites, proclaiming the dangers of vaccines for kids and the lack of any need to have one’s children immunized. These celebrities proclaim that you should trust what they say and not trust what your kid’s doctor says. Enough people today believe them so that we have a genuine danger to the public health. So I think we have reason to view trust in medicine as a precious public commodity, and dangers to that trust are matters of serious import.

Now, how do we proceed when we realize that two things are true?
1. Physicians and industry, working together, are needed for future innovations in health care that will greatly benefit future patients.
2. COI is a serious matter and we must do whatever we can to reduce or eliminate it.

What I see industry mostly trying to do today is to stress truth #1 and to try to fudge truth #2. The truly responsible course of action by contrast would be to accept truth #2 and then ask, how would financial arrangements be altered between physicians and industry so as to maintain as much as possible of the essential features of truth #1. At least some of your recommendations strike me as positive moves in that latter direction. That is, physicians should be paid exactly what it costs to perform whatever actions actually produce the innovation, and should not have any financial entanglements with the company beyond that. Physicians should take the attitude that engaging with industry is an opportunity to serve the public health and not an opportunity to strike it rich. That may sound incredibly idealistic, but I agree with the IOM that the stakes are too high if we fail to act. What is scary about Sen. Grassley is not that he is exposing greedy, irresponsible docs. It is that doing so on his part is like shooting fish in a barrel—he has such a wide choice of easy targets that he hardly knows whom to expose first.

A small point—I think an economics purist (of which I am certainly not one) would object to anyone who extols both the free market and the patent system. A patent is a state-granted monopoly and hence by definition an interference with the free market—a justified interference if it results in the social good of increased invention and innovation. Bu it ain’t the free market.

I later had some responses from this correspondent, and have myself responded back. I will send him a copy of this post to see if he wishes to have his comments made public, either with name identified or anonymously.

1 comment:

Dan said...

Conflicts of interests are not judged subjectively. They either exist, or they do not. It's a situation in which the regard for one duty leads to disregard of another, potentially or actually.

Essentially, in medicine, this is gifting, or the intent of gifting, and will likely affect the reliability of the receiver while providing benefit to the gifter. Reciprocity and quid pro quo have been established once this occurs. Gifting is also known as bribing.

As such, the receiver is now conflicted, compromised, and their best judgment is now clouded. Clinical research conducted and manipulated by pharmaceutical companies are examples of conflicts of interests.

Falsifying clinical research that is entirely premeditated by such criminals, as well as not sharing if not destroying negative data that may reflect their product is in fact a panacea screams conflicts of interests.

Why does this progressively occur, this bastardization of the scientific method?

Guidelines, if they exist, are intentionally ignored, as the manipulators have bought an atmosphere of profitable autonomy.

The revolving door between say congress and the DOJ with huge law firms that represent criminals and wrongdoers shouts tacitly “we are the poster children for conflicts of interest”, by allowing such autonomy to exist.

There has been a marriage made in hell. As a result, the health of others is not restored or harmed.

And no one stops this atrophy from happening- this toxic and anaphylactic death that is happening to our medical innovation, or lack of it existing at all.

Dan Abshear