Ethics for sale.

Health and medicine explained.
Dec. 13 2005 1:01 PM

Ethics for Sale

For-profit ethical review, coming to a clinical trial near you.

If you missed the movie The Constant Gardener and need your fix of moral outrage, you don't have to go to Africa to find it. Just look instead at the December cover story in Bloomberg Markets about America's largest clinical testing center. Managed by a company called SFBC International, according to Bloomberg, the 675-bed Miami testing center has been recruiting undocumented Latino immigrants desperate for money, housing them in a converted Holiday Inn, and paying them to take untested drugs in studies overseen by an unlicensed medical director whose degree comes from an offshore medical school in the Caribbean.           

So far, the plot is depressingly familiar. Drug companies spend $14 billion a year testing new drugs. The products need to be tested for safety on healthy people, and the healthy people most willing to ingest them are usually those with plenty of time and little money. Nearly 10 years ago, the Wall Street Journal reported that Eli Lilly and Company was recruiting homeless alcoholics to take part in drug trials in Indianapolis. In 2003, a previously healthy college student named Traci Johnson committed suicide in Lilly labs after being paid to take a new version of an antidepressant. Now Bloomberg is reportingthat three years ago, Garry Polsgrove, a homeless Vietnam veteran, checked into the Fabre Research Clinic, a for-profit testing center in Houston. Polsgrove was in good health when he entered the study and started taking clozapine, an antipsychotic drug, in order to get some cash and a place to sleep. Twenty-two days later he was dead of myocarditis.  

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The new wrinkle in the Bloomberg story is that many of the questionable practices it reports unfolded under the nose of the for-profit organizations that researchers increasingly hire to conduct ethics reviews. In the United States, the primary means of protecting research subjects are ethics committees known as institutional review boards. IRBs originated in the 1970s in the wake of various medical research scandals like the Tuskegee Syphilis Study that left black men untreated for syphilis between 1932 and 1972, and a notorious study at the Willowbrook State School for the Retarded in New York, in which researchers intentionally infected mentally disabled children with hepatitis A. The idea was that to protect the welfare of research subjects, all studies would be reviewed in advance by an ethics committee independent of the researchers conducting the study, whose scientific zeal might lead them to shortchange safety. Traditionally, IRBs have been volunteer committees made up of scientists and clinicians working in the hospitals and medical schools where the studies they review are being carried out. 

Today, however, the ethics review of more than half of all new drug submissions to the Food and Drug Administration is handled by a single for-profit IRB, Western Institutional Review Board in Olympia, Wash. (according to Western's owner, Angela Bowen, as quoted in Bloomberg). At the SFBC clinic in Miami, some of the ethics review was done by a for-profit IRB owned by the wife of an SFBC vice president. At the Fabre Research Clinic in Houston where Garry Polsgrove died, the ethics review was conducted by a for-profit IRB run by Louis Fabre, the clinic owner. (The Fabre clinic and its IRB have since shut down.) If you find yourself down on your luck and are tempted to volunteer for an industry-sponsored drug study, chances are that you will be entrusting your safety to a private board that is operating with very limited government oversight, and that is being paid by the drug company whose drugs you are taking.

How did we get here? When IRBs were established a generation ago, medical research was conducted mainly by individual investigators working in medical schools who were funded by the federal government and who had little financial stake in their studies. These days, medical research is a massive, multinational corporate enterprise. Rather than contracting with academic researchers to test new drugs, the pharmaceutical industry has found it cheaper and more efficient to conduct studies in physicians' offices, industry laboratories, and private testing sites like SFBC's in Miami. As recently as 1994, 63 percent of clinical trials were taking place in academic settings. Ten years later, that figure had shrunk to 26 percent. Along with private-sector clinical research has come private IRBs, which market themselves by promising fast and industry-friendly service.

The demand for private IRBs isn't hard to understand. In today's research environment, academic IRBs often are overmatched. They're often slow and inefficient, and they are staffed by volunteers who would usually rather be somewhere else. Nor are academic IRBs free from conflicts of interest. Their members are frequently asked to review studies being conducted by their friends and colleagues. And a recent survey of academic IRB members found that nearly half had served as consultants to the drug industry.

But the private IRBs have a direct financial interest in keeping their drug-company clients happy. If one for-profit IRB rejects a study as unethical, the pharmaceutical company sponsoring the study can simply send it somewhere else. Free-marketeers argue that there's a countervailing pressure that should make drug companies welcome strict policing from the IRBs—the possibility that a strict ethics review on the front end could head off a lawsuit on the back end. But in reality, the incentives don't pan out that way. Lawsuits, while on the rise, are still relatively rare. For the companies bankrolling the clinical trials, litigation is a quite-manageable cost of doing business.

Surprisingly, for-profit IRBs have drawn little criticism from bioethicists. Instead, some university and government scientists are increasing their influence. A few universities, such as Johns Hopkins, have begun using for-profit IRBs to review their research. Ezekiel Emanuel, the chief of bioethics at the National Institutes of Health, spoke enthusiastically about for-profit IRBs in general and Western IRB in particular during a presentation about research review that he made to the President's Council on Bioethics a few years ago. "I think there are a lot of reasons that make Western and a few of the others very good," Emanuel said. "One is certainly leadership and dedication to doing the right thing, and believing that by doing the right thing, you'll be successful, and in their case profitable." Yet according to Bloomberg's December cover story, Western IRB gave ethical approval to studies in Los Angeles and Georgia that later turned out to be fraudulent. The researchers involved reportedly wound up in prison for lying to the FDA and putting the lives of subjects in danger. Western IRB has also been sued for approving a placebo-controlled study of a Genentech drug called Raptiva. In that study, Bill Hamlet, a patient in North Carolina ill with psoriatic arthritis, claims that he was taken off his regular medications, which had been effective, and given a placebo instead. When Hamlet withdrew from the study six months later, he says his body was covered with bleeding scabs and he was bedridden from his psoriatic arthritis. The lawsuit was settled out of court.

IRBs were never intended to be formal regulatory bodies. They were supposed to provide a kind of professional self-regulation, in which scientists were advised by their colleagues. "I will begin by noting that IRBs are not policing bodies, watchdogs, or auditing agents," Robert Levine of Yale University, the former editor of the journal IRB, said when he testified before Congress in 1998. "IRBs were established to work collaboratively with investigators." That mission might have made sense 30 years ago. Today, however, the prevalence of private-sector drug research and the push to commercialize every facet of medical research makes the original model hopelessly outdated. Research subjects need a watchdog to protect them, and not one that is owned by the pharmaceutical industry. If IRBs cannot do the job, then we need to replace them with something that can.

Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota and author of White Coat, Black Hat: Adventures on the Dark Side of Medicine.

Trudo Lemmens is a law professor at the University of Toronto and co-editor of the forthcoming book Law and Ethics of Medical Research: Regulation, Conflict of Interest, and Liability.

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