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.
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…. That doesn’t mean that I don’t like and appreciate the science…. I try to understand the direction each pharmaceutical company goes when they’re using this compound in this indication, which is targeting blah blah blah, whatever it is.
Private-sector physicians are also quite comfortable serving as PIs on clinical trials outside their specialty training and expertise. A neurologist provided this explanation for why he’s served as a PI for studies on depression, weight loss and gastroesophageal reflux disease:
I do not do original research; I do contract research. I read the neurology literature; I do not read the psychiatry literature; I don’t read the obesity literature. You know, for certain things, I’m pretty smart. And in other things, I don’t even pretend that I’m smart about those. But I’m very good at running clinical trials, so in a sense… I’m a highly skilled practitioner of clinical trials who has an appreciation for the science, plus the scientific need, plus the fact that they rely on the data that we give them to be scientifically valid because there are lives at stake in that data. But I’m not a scientist.
Here’s what another physician had to say (rather gleefully) on this topic:
You know, we really don’t have a lot of leeway in the scientific department. I mean, if somebody says we have this really great drug that works for blood pressure, I have no idea how this damn thing works! But I’m still going to go down the hall and do physicals and check blood pressures and sign off adverse events. … I have no idea about science! Whether that’s good or bad or indifferent. That’s why we’re doing the research, and I figure someone’s putting several million dollars, or $20 million into doing this study, so they must believe in what they’re doing.
That attitude also affects the physicians’ perception of research ethics. The PIs interviewed in the PLoS Medicine study talked about “the importance of following the protocols and avoiding misconduct or fraud,” write Fisher and Kalbaugh. But the doctors were also surprisingly candid about some of the ethical temptations they face, particularly in regards to “massaging the data.” Here’s an example:
There’s all sorts of ways people will justify blurring lines of distinction, which may or may not be clear actually. Throwing away a lab value is way over the line, right? Does it have to be fudged when you’re doing a blood pressure study and this person is two points out of range on their fifth visit, and you’ve already put in a month of time on that person? I don’t know. Does that betray the spirit of what you’re trying to do? As opposed to ten points out of line, then they’re out. So I can see how individual people will sort of figure out where they’re comfortable on that.
And then there’s this disturbing quote from one of the physicians:
Obviously, there’s an ethical standard that the physicians will be following, but, of course, everyone knows there’s shades of pressure around your proper ethical behavior which may be trying to push or negotiate certain decisions that the physicians [are] making or certain opinions that they’re forming, to comply or go along better with others [at sponsoring companies] who are pressuring him or her [to enroll/retain participants].
This study has its limitations, as its authors point out. Only a small number of people were interviewed, for example, and they all worked in one geographical area. In addition, the interviews were conducted eight years ago, so it’s possible that private-sector physicians have altered their attitudes toward clinical research.
I somehow doubt it, though.
You can read the study in full on the PLoS website.