Politics & Policy

What the Doctor Ordered

"Bench to bedside" saves.

Is your physician under the influence? He or she is indeed, according to the Association of American Medical Colleges.

The new Report of the AAMC Task Force on Industry Funding of Medical Education has called for a ban on “gifts,” such as pens and mugs with company logos, handed out to doctors by drug companies promoting their products.

#ad#“Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception . . . of being ‘bought’ or ‘bribed’ by industry,” says the report.

In proposing a gift ban, the AAMC is accelerating a trend already well underway. For several years, the American Medical Student Association has held annual PharmFree Days. In 2004, it celebrated the occasion by dumping thousands of branded paraphernalia outside Pfizer headquarters. Last month, politicians weighed in; the Massachusetts state senate passed unprecedented legislation that would impose a fine of up to $5,000 on physicians accepting so much as a mouse pad from a drug company.

If these reactions to cheap plastic pens seem overwrought, it’s because token gifts are the tangible symbol of industry presence within academia. The legitimacy of that presence has become a subject of much soul-searching among physicians. Do various financial relationships between doctors and the pharmaceutical industry — promotional marketing, paid speaking and consulting, and research funding — compromise patient care, bias medical research, and diminish the integrity of the profession?

These questions deserve serious consideration, especially given the prominence of conflict-of-interest allegations in the news. Recall recent headlines about lung-cancer researchers from the Cornell Weill Medical Center who appeared to conceal their funding from a tobacco company along with other commercial ties. A few weeks later the spotlight was on physician-scientist “authors” whose published papers on the pain medication Vioxx were reportedly written by its manufacturer.

Unfortunately, on many medical-center campuses, the verdict is already in: physicians who engage in any financial relationship with industry are not to be trusted.

“It is not worth it to be under suspicion,” the chief of cardiovascular medicine at Harvard’s Brigham and Women’s Hospital told the Times’s Gina Kolata recently. Shaken after being attacked for having consulted with makers of pharmaceuticals and medical devices, he no longer accepts payment.

David A. Shaywitz, an endocrinologist, has commented on the “witch hunt” atmosphere in medicine today. “I’ve seen young, talented faculty members counseled — sometimes aggressively — out of going to work for the pharmaceutical industry,” he told me. “They are being told they are selling out to the ‘the dark side.’ ” Shaywitz spent over a decade training as a physician-scientist at Harvard and MIT before going to work for Merck (and later becoming a management consultant).

It is one thing to scrupulously avoid the taint of company tschotckes. It is quite another to turn around and denounce the professional aspirations of young scientists while smearing academic-industry collaborations. Such blanket condemnation of all associations with the companies that invent and produce countless life-saving healthcare products will surely have real costs to society. These partnerships are vital to medical progress.

#page#A key example is drug development. It starts with university scientists who develop and then patent novel molecules and other inventions. They license those patents to private companies for “translation” into actual therapies. These vibrant collaborations have produced dozens of life-saving therapies including the vaccine for hepatitis B, beta interferon for multiple sclerosis, and Herceptin for breast cancer.

This classic “bench to bedside” process would be impossible without industry’s help because the process is so hugely expensive. Nor would it be possible without the participation of scientists like Dr. Shaywitz.

Many of the best scientific minds have thrived because of their work with industry. A 2007 analysis by two UCLA economists found that academic scientists who sell their ideas or start firms to build upon their discoveries tend to be top people and their firms tend to lead in innovation. And those top people are the ones whose expertise private companies and government agencies need to tap. The problem is that efforts to manage conflict of interest — an admittedly sprawling term that includes everything from the appearance of impropriety to subtle pressure to act in the favor of a company to overt manipulation of research — curtails access to expertise.

Consider the Food and Drug Administration (FDA). By law, outside scientists cannot serve on FDA advisory committees without first being granted a waiver if they have financial interests in particular matters being considered. These can be stock in the company that makes the drug under consideration (and its competitors) or paid consulting to the drug maker. Waivers go to those whose strength of expertise is judged to outweigh potential conflicts of interest.

These members tend to be the best in their field. According to a study commissioned by the FDA last year, advisors receiving waivers had a significantly higher overall expertise than those not needing waivers. Waivers are a reasonable approach to maintaining the integrity of the advisory process, but last year Congress limited the FDA’s ability to grant them. By 2012, the agency must reduce the number of waivers it grants by 25 percent. Over the years, some lawmakers have urged revoking waiver privileges altogether in order to eliminate any contact with people who have any industry involvement.

Thankfully, the AAMC report is respectful of the needs of advisory bodies and the importance of industry collaborations. But at the same time, its proposed gift-ban risks inflaming the suspicion that doctors are too readily swayed.

We can live without free pens and mouse pads. The real threat to medicine and the public interest is suppression of freedom of university-based researchers to interact with their scientific colleagues in the pharmaceutical industry. That might make anti-industry purists feel better — at least until they look for the next breakthrough drug only to find that it doesn’t exist.

 – Sally Satel is a physician and resident scholar at the American Enterprise Institute.

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