If the past decade had an emblematic moment for clinical research, it was probably November 12, 2005, the day when Bloomberg Markets published its cover story, “Big Pharma’s Shameful Secret.” In that issue, Bloomberg reporters laid out the story of SFBC International, a contract research organization in Miami that was paying undocumented immigrants to test the safety of new drugs in a seedy motel. The SFBC owners had converted the lobby into a large waiting area with plastic chairs, and they were housing their research subjects six to a room. The medical director of the research site was unlicensed to practice medicine; the Institutional Review Board that approved many of the studies was owned by the wife of the company vice-president; and the converted motel, which had been cited for fire and safety violations, was eventually demolished. Nonetheless, SFBC had become an astonishingly successful enterprise. Just a few years before the Bloomberg Markets report, Forbes had named SFBC one of the most admired small businesses in America. Virtually every major pharmaceutical company had tested drugs with the company. In fact, with 675 beds, the converted motel was the largest research facility in North America.
Thirty years ago, when drug companies needed to test new drugs in humans, they usually went to university medical centers. Universities gave drug companies prestige, technical expertise, and most importantly, a deep well of human subjects. Starting in the early 90s, however, the landscape began to shift. Clinical trials started getting larger and more complex. Drug companies needed more research subjects, and it needed to recruit them into trials faster. So companies began taking their business to private companies like SFBC. In 1994, two out of three trials were done in universities; by 2004, three out of four were being done in private testing sites. Today, virtually every aspect of a drug study can be outsourced to a specialized, for-profit company: management, subject recruitment, publication, even ethics approval. Most people look at photos of the SFBC trial mill and think, “This is a research facility?” But university medical centers look at those photos and think, “This is our competition.”
These days, if universities want to compete for clinical trials, they have 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 IRB’s. 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.
In Jill Fisher’s recent book about clinical trials,Medical Research for Hire, a medical researcher explains, “I do not do original research. I do contract research.” Contract researchers, unlike traditional academic researchers, do not typically design studies. 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.
If there is such little intellectual work involved in contract research, why are universities so eager to be involved? One reason springs from the central theological dogma of academic medicine, which affirms the supreme value of all medical research. This faith in the value of research 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.
But the more important reason is money. In medical schools, faculty members are often expected to generate their own salaries, either by seeing patients or getting grants and contracts. 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.
This system has not been good for human subjects, but it has not been good for academic physicians either. According to a recent study of over 5,000 faculty members at U.S. medical schools, 51 percent of respondents said that “the administration is only interested in me for the revenue I generate.” Thirty-one percent said that their institution discourages altruism; 27 percent said that it does not reward clinical excellence; and over half said that it does not value teaching. Nearly half of respondents were considering leaving their current jobs; almost a third were considering leaving academic medicine altogether. Asked if their values lined up with the medical schools where they worked, over half said no. And just in case you are wondering why these physicians are not standing outside the building with picket signs, protesting the injustice of the system, the survey offers another clue. Thirty percent of respondents agreed with the statement, “I am reluctant to express my opinion for fear of negative consequences.”
Of course, this survey does does not exactly match up with the happy propaganda disseminated by the media-relations offices at most medical schools. Instead, it offers a picture of alienated, demoralized physicians, unhappy in their jobs, pressed to work according to values that repel them in order to prop up an institution that views them primarily as instruments to generate profit. In this environment, contract research makes perfect sense. It may not require much intellectual work, but it pays the bills and keeps the authorities happy. And if medical schools don’t really value intellectual work anyway, that may well be enough.
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
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Thanks for this Dr. Elliot. I think it’s important for us to understand the “business model” we are up against. I wonder if there are well known pockets of excellence when it comes to original research? Research with integrity?
Thank you for writing this; unbelievable and ‘their bad’ for SFBC!!! Big Pharma just keeps getting uglier and uglier, greedier and greedier….. big business in America unfortunately!