How To End the Ties That Bind

What? No tchotzkes?

A panel of prominent physicians has called for ending many practices that give the drug and medical device industries inordinate influence over the nation's 400 teaching hospitals and 125 academic medical centers.

In an article in today's Journal of the American Medical Association, a group associated with the George Soros-funded Institute on Medicine as a Profession at Columbia University (IOMP) proposed prohibiting drug companies from giving small gifts or paying for the meals, travel or continuing medical education of teaching docs. They also recommended ending the distribution of free drug samples in favor of giving vouchers to hospitals.

The group didn't stop there. They also called for hospital formulary committees to eliminate from their ranks any physicians with ties to drug manufacturers. Those committees play a key role in medical decision making by determining the best drugs to use in various medical situations.

While they didn't call for a ban on faculty participating in outside consulting or receiving speaking honoraria and industry research contracts, the IOMP group did say each contract should be tied to a specific deliverable (i.e., no "no strings attached" grants). "To better ensure independence, scientific integrity and full transparency, consulting agreements and unconditional grants should be posted on a publicly available Internet site, ideally at the academic institution," the group wrote.

The IOMP proposal, if voluntarily enacted by the nation's medical schools, would set a new standard for policing conflicts of interest and would go a long way to purging industry influence from academic life. But I see several problems with the proposal.

First, by focusing on the nation's academic medical centers, they ignore the fact that most of the drug and device industries' marketing practices are aimed at the nation's nearly one million practicing physicians, not the elite in the nation's medical schools. The last time I visited my doctor, drug paraphenalia -- the pens, pads, cups and calendars, not to mention free samples -- were everywhere. What about her?

It's true the teaching docs set the standard and provide the "thought leaders" in many medical specialties. But there is a large and growing continuing medical education industry (an adjunct of the advertising and public relations industries really) that is no longer beholden to the academy for its expertise. Their influence will only grow if this proposal is limited to academic medical centers.

Moreover, the practice of medicine is heavily influenced by clinical practice guidelines written by professional associations or patient advocacy groups like the American Society of Clinical Oncologists or the American Heart Association. This is where the rubber of industry influence meets the road of medical practice. Indeed, more and more insurance companies and even Medicare are moving toward rewarding physicians and hospitals for sticking to the guidelines as part of "pay for performance" schemes.

While many academicians sit on these guideline writing committees and most groups have strong conflict-of-interest disclosure requirements, industry exerts extraordinary influence over the guidelines either through direct funding of these groups or ongoing relationships with members of the guideline-writing committees. This proposal does nothing to liberate the writing of clinical practice guidelines from industry influence.

Finally, their proposal would place restrictions on industry-funded clinical trials at academic medical centers. If I read the proposal correctly, they would eliminate individual grants to researchers for specific projects in favor of only allowing industry grants for general support of research. Presumably, this would leave the individual investigators free to design their own trials with their eyes set on determining what is best for the practice of medicine, not what is best for marketing a specific drug.

Over the past 30 years, the ratio of industry support for clinical trials has jumped from 30 percent of all research to nearly 70 percent. It accounts for a majority of the 15-20 percent of industry funds spent on research and development and a substantial fraction of the 25-30 percent of industry funds spent on marketing (these latter trials are sometimes called "seeding" trials; the industry lines up hundreds of doctors across the country to prescribe their latest drug even though it has already been approved by the Food and Drug Administration; it's a way of getting them to use the drug in their regular practice).

If this proposal is limited to academic medical centers, a large part of the clinical trial spending conducted there will simply gravitate to the private sector. The private contract research organizations like Parexel and Quintiles, which are already growing by leaps and bounds, will get another huge shot in the arm. More trials will simply move off-shore.

These reforms need to go much deeper. The IOMP should have included the parent organization of the journal where their article appeared -- the American Medical Association -- in their list of organizations that should adopt the reforms. They also should have included the Accreditation Council for Continuing Medical Education, the voluntary group that certifies which CME providers meet its standards for continuing medical education credits (which are required for maintaining physican licenses in virtually every state). And they should have spoken out about industry influence over patient advocacy groups like the American Cancer Society and the American Heart Association, which include many industry-affiliated physicians in prominent positions.

Finally, they should have expanded their horizon to include the federal government -- specifically, the Food and Drug Administration and the Centerfor Medicare and Medicaid Services. Conflicts of interest need to be ended on the outside advisory committees for the gatekeeping agencies that approve new drugs and devices and that determine what drugs and devices will be reimbursed.

After all, conflicts of interest are all about the money. So in looking for places to apply the new standards, they should remember Willie Sutton's maxim: go where the money is.

Posted by gooznews at January 25, 2006 06:07 AM