Newspaper article

Private-Sector Physicians Run Clinical Trials Mostly for the Money, Study Finds

Newspaper article

Private-Sector Physicians Run Clinical Trials Mostly for the Money, Study Finds

Article excerpt

A study published this month in PLoS Medicine offers more troubling insight into how big money, rather than scientific inquiry, is driving and shaping much of our current medical research.

This time, researchers examined the motives of the ever- increasing number of private-sector physicians -- ones not affiliated with academic institutions -- who serve as principal investigators, or PIs, for clinical trials funded by the pharmaceutical industry.

Those motives are important. For how -- and where -- drug trials are conducted in the United States has undergone a major shift during the past two decades. In the 1980s, most clinical trials took place at universities and other academic institutions. By 2005, more than 70 percent of U.S. clinical trials were being done by nonacademic physicians. In fact, the number of private-sector physicians involved in these studies climbed from 4,000 in 1990 to a staggering 20,250 in 2010.

In other words, much of what we're told about the drugs and other medical treatments we receive is determined by the studies these physicians oversee.

To find out the implications of this trend, the authors of the PLoS Medicine study, Vanderbilt University bioethicist Jill A. Fisher and University of North Carolina at Chapel Hill doctoral student Corey A. Kalbaugh, conducted interviews and at-work observations of 63 physicians and other research staff at 25 private- sector research organizations in the southwestern United States.

Not surprisingly, they found that money was the primary reason private-sector physicians become contract researchers. (This group of physicians said they earned up to $300,000 a year for their work as PIs.) But the study also found that physicians view their role in the clinical trials as having more to do with business than with science. As a result, the physicians have also adopted industry's approach to research ethics.

"What was striking in our research was that more traditional views of ethics, especially the investigator's responsibility to trial participants, were not explicitly evident," write Fisher and Kalbaugh.

Candid comments

Some of the details of this study's findings -- particularly certain quotations from the doctors and others who were interviewed - - are, well, jaw-dropping.

Here, for example, is an industry representative's explanation for why it's so easy to recruit private-sector physicians to be PIs:

Doctors want to do the research because it's profitable. They don't want to spend the time to do it, and right now, the way the industry's set up, they can do that. They can hire a nurse and a couple coordinators to essentially run 98% of the study for them, make them a lot of money, and they do minimal work.

"Indeed," add Fisher and Kalbaugh, "several study coordinators in our sample joked about how clinical research helped physicians improve their golf games. Our observations confirm that at the majority of the 25 sites at which we conducted our research, the PIs were frequently absent from the clinic."

The study also found that few of these physician-PIs analyzed the data collected in their trials -- or even participated in writing the final study.

More interested in business aspects than science

That physicians look upon these clinical trials primarily as a lucrative business venture is also apparent in how they choose to earn their annual continuing medical education requirements. Fisher and Kalbaugh found that physicians who contract out as PIs often attend business-related rather than scientific panels at professional conferences. Here's what one of the physicians told them:

I go religiously to the [annual specialty meeting] strictly for business development purposes. …

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