Saturday, May 21, 2005

Is the adversary model the answer?

In his post of Wed 18 May, Roy Poses commented on the PLoS article by former BMJ editor Richard Smith opining that medical journals have been co-opted into Big Pharma's marketing system. Coincidentally, the BMJ reports that the CEO of Merck has resigned, in a move widely seen as a response to the increasingly damaging disclosures about Merck's marketing of Vioxx (though Merck of course denies any connection).

Merck's campaign for marketing Vioxx was clearly a campaign of deliberate deception, with intensive training of detail reps in specific techniques for misleading physicians about the benefits and concealing the risks of the drug. Should we be surprised? No, not really. Consider what is at stake for any drug company marketing a new agent. Hundreds of millions of dollars have gone into its development. Even though the company itself probably hasn't paid for much if any of the actual basic science or discovery, the development of someone else's discovery to marketability costs a bloody fortune. There's no predicting whether it'll be a big seller, a market mediocrity, or a fiasco that proves dangerous but only after all the costs are incurred.

When big money is at stake, people will lie. It's human nature. Are they "bad people"? No, they're people. As the Milgrom experiment and others showed, and WWII gruesomely illustrated, the majority of people can convince themselves that literally anything - no matter how abhorent - is OK. We vastly underestimate in our usual thinking how readily people will believe what's in their interest to believe. Not just a few "bad apples", but the majority of normal people. Further, those few who are squeamish about fibbin' a bit in marketing the product are selected out at low rungs on the corporate ladder in Big Pharma. The upshot is that we just plain have to assume that Big Pharma will lie. Not because they're evil, but because they're humans in a system where extremely strong incentives exist to do so.

So what do we do? Well, we could propose that drug development be placed in the hands of neutral foundations or some similar arrangment that divorces self-interest from the product. Personally, I doubt that will work well though. The nice thing about self-interest is that it really motivates people. Only self-interest will reliably make the majority of people really work hard. Folks just naturally coast a bit if they don't have skin in the game. (You don't need to point to the economic failure of communism to illustrate that point; just check out any organization that has no competitors. Go down to the Secretary of State's office to get your driver's license paperwork, for example.)

So it's time we formally and clearly recognized that doctors and their patients vs. Big Pharma is an adversary relationship. Like prosecutors and defense attorneys, we need each other and society needs us both, but like any good defense attorney we're nuts to trust anything the prosecutor says. (The metaphor is apt, sadly, as the shocking number of falsely convicted men freed from death row or life imprisonment over the last decade demonstrates.) If we want to do the best for our patients, we need to behave adversarially toward Big Pharma. Don't socialize; assume an ulterior motive; if given a paper "proving benefit" look for how it might have been fudged or find out how many negative papers are being kept out of view; never believe industry-funded clinical trials; assume risks are being downplayed and benefits overplayed.

An adversary relationship will put a real crimp in the incomes of quite a few physicians who are used to taking drug money. It'll also raise some serious financing issues for CME, but it's time those came out on the table anyway. Patients deserve much more aggressive protection of their interests than our profession's cozy relationship with Big Pharma has provided. Time to un-cozy.


james gaulte said...

Thank you for an excellent posting.Recently,I blogged about how we need to include "skepticism teaching" to medical students particularly as regards drug company funded trials and the other ploys described by Dr. Smith.

Roy M. Poses MD said...

Interesting ideas, but I wonder whether adversary here may be a bit extreme. All physicians do need to be skeptical of claims made by people and organizations who may prove to be self-interested. A quick perusal of this blog will show that physicians should be very skeptical of big pharma and its leaders, but also of the leaders of practically every other type of large health care organization: big hospitals and health care systems; big managed care and insurance; big device manufacturers; big IT vendors; big government agencies; etc., etc. etc.
Furthermore, we need some watchdogs who will keep an eye on these organizations, big ones, with loud growls and sharp teeth. Physicians are probably best qualified to become such watchdogs, but should work primarily in partnership with patients, the ones most affected by organizational mismanagement and skullduggery.

Bernard Carroll said...

One tool available to us physicians is the ethics codes of our professional associations. For instance, individual members of most associations can be censured and expelled for criminal conduct, that need not be related to our clinical practice. By the same logic, corporations that are the subjects of adverse court rulings, regulatory fines and settlements need to learn that there are consequences for such behavior vis a vis their access to professional medical organizations. And we are the ones who should deliver this lesson.

For instance, many corporations enjoy the status of "Supporting Corporations" and are prominently listed, along with company descriptions (blurbs) in the Directory of Members of American College of Neuropsychopharmacology (ACNP). These corporations have recognized liaison staff who also are listed in the Directory of Members. They enjoy access the the annual meeting of ACNP, where many deals are struck with academic members. Likewise, the American Psychiatric Association sponsors a huge exhibit hall at its annual meeting, with lavish, high-tech booths operated by the corporations. The corporations also host CME symposia at the APA annual meeting through "unrestricted educational grants", while having every confidence that all the featured speakers are "on message."

ACNP and APA have every right and, I would say, the duty to terminate or suspend the access of corporations that receive criminal judgements or adverse regulatory judgements. And I would not restrict the focus to the professional society's speciality. In other words, ACNP and APA should not restrict their focus to just the corporations' ethical behavior vis a vis neuropsychopharmacologic or psychopharmacologic products. That would send a powerful message.