University of Minnesota bioethics professor and journalist Dr. Carl Elliott (“White Coat, Black Hat: Adventures on the Dark Side of Medicine”) has begun a weekly online column for The Chronicle of Higher Education, one of the most interesting magazines being published these days.
His first contribution, which appeared Wednesday, takes on a dark topic that many academic researchers in university medical centers are unwilling to discuss, at least publically: how, in their increasingly desperate need to compete with private companies for Big Pharma clinical-trial money, many of them have had to give up much of their academic independence and become, essentially, contract researchers.
“Contract researchers, unlike traditional academic researchers, do not typically design studies,” explains Elliott. “They do not analyze the results of trials, or interpret them, or help write them up for publication. In fact, they make little if any intellectual contribution to the studies. They simply recruit subjects and oversee their medical status in the trial, which may well be conducted at dozens of different locations. Like drones responding to the queen bee, the contract researcher just follows instructions issued from central command.”
Thirty years ago, drug companies relied almost exclusively on universities to test their new drugs in humans. The universities “gave drug companies prestige, technical expertise, and most importantly, a deep well of human subjects,” notes Elliott.
On the company’s terms
But those days are gone. “These days,” writes Elliott, “if universities want to compete for clinical trials, they have [to] do it on terms set by market forces. Their faculty members have to be better recruiters than private trial sites. Their Institutional Review Boards have to give ethical approval to trials faster than for-profit IRBs. They have to conduct their trials faster and cheaper than their counterparts in the private sector, or else the drug companies will simply take their business somewhere else. Ten years ago that might have meant a converted motel in Miami or a strip mall outside Philadelphia. These days it is just as likely to be a clinic in Warsaw, Manila, or Bhopal.”
Why are universities so willing to be part of this? One reason, says Elliott, is their enduring faith in medical research — a faith, Elliott points out, that “has been undeterred by a spectacular string of fraud scandals involving drugs such as Vioxx, Bextra, Seroquel, Zyprexa, Avandia, Paxil, and Neurontin, many of which implicated academic medical researchers and caused the needless deaths and injuries of unwitting human subjects.”
The role of money
But money is the real driving factor being academia’s willingness to become contract researchers, Elliott says.
“In medical schools, faculty members are often expected to generate their own salaries, either by seeing patients or getting grants and contracts,” he writes. “Likewise, academic departments are often expected to be financially self-sufficient, with as little support as possible from central administration. ‘Eat what you kill’ is the phrase used, without irony, by medical school deans and department heads. And if you are not killing it with NIH grants, you probably need to be killing it with AstraZeneca or Pfizer.”
The academic chase for BigPharma money has consequences for consumers, of course. The fewer truly independent researchers we have, the less we can trust what our medical studies tell us about various drugs and other medical treatments.
You can read Elliott’s inaugural column on the Chronicle of Higher Education web site.