September 01, 2009

By: DANIEL CARLAT

Regulation is harmful.

Start with the following three facts: First, diseases kill people. Treatments, including medications, help to manage and cure diseases.

Second, physicians working with industry have developed and made available the vast majority of current treatments. This working relationship includes research and development, physician education, and joint monitoring for postmarketing safety. There is tremendous value in this working relationship for science, the practice of medicine, and for patients.

And third, participation in research and development, and education of peers on this research, is part of the legal, moral, and ethical work product of physicians. Payment for the work we do is not a “conflict” of interest. Rather, it represents a commonality of interests that is an integral part of the profession of medicine (Endocr. Pract. 2009;15:289). There is improvement in patient care, advancement of science, and benefit to medicine from these professional activities.

Given these facts, one must question the wisdom of disrupting the physician-industry working relationship. Those who claim that physicians working with industry are immoral, unethical, or corrupt create harm to patients and to medicine. They will cost society not just the public's trust, but also the human costs of hindering research and development and disrupting the expedient implementation of newer, safer, better treatments. Ultimately, untreated disease will incur a higher financial cost to the health care system.

Opponents of the physician-industry working relationship want better patient care. We all do. Let's agree that disclosure of working relationships is important—let's also agree not to call it a “conflict.” Finally, let's agree that “gracious professionalism,” which fundamentally says you will behave as if your grandmother were watching, should be the standard for any debate.

All clinical research and development must be physician led. There is no alternative. Physicians also should take the lead in the development of education. Those who carry on the research should be the ones to pass on the knowledge to their peers. They are the most expert by both necessity and experience, and thus must not be excluded from CME-accredited programs, with proper disclosure. “Teaching” that there is bias in industry-funded education lacks balance. It creates another bias: that medical education without access to all sources of information (or the ability to acquire the skill to discern good from bad data) is complete medical education.

Physicians should be proud of the value that comes to science, the profession of medicine, and patient care from the constructive partnership between physicians and industry.

Regulation is necessary.

Recently, I attended the charter meeting of the Association of Clinical Researchers and Educators (ACRE), a new organization that is founded on the belief that physician-industry interactions have become overregulated.

I disagreed with many of the presenters, but on one point I was in absolute agreement. Interaction between industry and physicians is a good thing. In fact, it is crucial for scientific progress.

Pharmaceutical and device companies depend on doctors for advice on how to design research. They need us to enroll patients in clinical trials to test new treatments. They need us to help them devise new instruments and procedures. We, in turn, depend on industry to develop and market the treatments we and our patients need. I don't want to prescribe blindly. I want to know the right dose, the side effects, how the drug is metabolized, and more. I depend on the manufacturer to tell me these things. I read their package inserts, I read their ads, and I talk to their reps. These are all completely legitimate interactions. Sure, it's marketing, but I know that going in. Companies make products and have every right to educate us about how to use them.

But suppose I want to find out whether Drug A is better than Drug B. Would I go to Company A for this kind of advice? Of course not—in fact, this is the last place I would go. This is because Company A has a financial interest in convincing me that Drug A is the best.

Likewise, I would not go to a physician paid to promote Drug A for this advice. I would go to a source without that conflict of interest. This is not because I believe that doctors who take industry marketing money are bad or unethical. It is because I know about human nature. When you have a financial incentive to paint the truth a certain way, it is highly likely that you will respond to that incentive. As a former drug company speaker myself, I know how true this is.

We need to regulate physician industry relationships, but we need to do this smartly. Severing all ties would be disastrous. Let's allow industry-funded research, as long as companies agree to publish all their findings, even when negative. Doctors who work with industry in this way often have great expertise, and we don't want to lose that. Such experts should be free to provide education to their colleagues in venues that do not involve industry funding.

What we need to regulate are the marketing relationships. There's no benefit to medical science or to patients when doctors accept payments to drive up sales of a company's product. In fact, the opposite is true. The spectacle of doctors being paid thousands of dollars to become glorified drug reps undermines the trust of society and our patients.

And without that trust, we have nothing to offer them at all.

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