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     Volume 4 Issue 64 | September 23, 2005 |

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The Body Hunters

Marcia Angell

(Continued from last week)

The rapid movement of drug studies to third-world countries began in 1980, when the US Food and Drug Administration (FDA), in considering applications to approve new drugs, first agreed to accept foreign trials as evidence of safety and effectiveness. Before a company can sell a drug in the US (or market an old drug for a new use), it must get approval from the FDA, which means it must demonstrate in clinical trials that the drug is reasonably safe and effective. Nearly every large drug company, wherever it is located, wants to get into the US market, because that is the major source of profit for pharmaceuticals.

Probably close to half of all clinical trials are now conducted in the third world, although there is no way to know for sure. The reasons are clear. It is cheaper and in many respects easier and faster to do them there. A huge new industry has arisen that conducts third-world research for drug companies (like le Carré's fictional research firm, ThreeBees). These companies, called contract research organisations, or CROs, hire local doctors to find people who will take part in clinical trials, and while the payments to the doctors per patient are lower than in first-world studies, by local standards they are munificent. Doctors can multiply their income tenfold or more. Patients, too, are readily enticed by small amounts of money and promises of free care. In fact, as in le Carré's story, enrolling in a trial may be the only way they can get any care at all.

This system makes a mockery of the notion of informed consent--the requirement that subjects be given full information about the nature of the research and have the right to refuse to participate, without penalty or consequences for their usual health care. That requirement is enforced in the US and other well-to-do countries, and partly for that reason, drug companies are having a hard time getting enough volunteers for the growing number of clinical trials. Not so in the third world, where authoritarian regimes and corrupt local government officials and health authorities are eager to be paid off by first-world organisations and to have good relations with them. They "encourage" entire villages or provinces to enroll in research programmes, while local doctors enrich themselves by providing human subjects.

Perhaps the most important reason for conducting human research in Africa and other poor regions outside the US is that it is a way of circumventing FDA regulations. In the US, drug companies are required to file "investigational new drug applications" (INDs) with the FDA before they begin human testing of a drug they hope to get approved. The applications give detailed descriptions of the proposed research, including plans for obtaining informed consent and for monitoring the progress of the study. Companies must also provide evidence that ethics committees (called institutional review boards, or IRBs) have been set up to review each clinical trial. These committees are supposed to ensure that risks to human subjects are, in the words of the applicable federal regulations, "reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result," and further, that all risks are "minimised." The FDA can deny approval of the IND or request changes in the proposed research. It may also conduct on-site inspections of the trials.

The requirements for foreign research are much looser. In fact, the FDA may not even know about such trials until after they are completed, when the company applies for final approval of a new drug. Only then when there is no longer an opportunity to verify the information does the company have to describe the way in which the research was conducted, or say whether there was ethics committee approval and informed consent. Furthermore, the FDA rarely conducts on-site inspections abroad. While it conducts very few in the US, there is always the possibility that it will decide to do so. For research done in the third world, the agency simply takes the word of the sponsors of the research.

When research does not require FDA approval, there may be no oversight at all. Companies can conduct preliminary studies of drugs in poor countries before formal testing even begins. Quite literally, the participants in their studies are used as guinea pigs, subjects of research that really should be done on experimental animals. That was the case in le Carré's fictional account. Although some research in the US and other wealthy countries also escapes formal oversight, there are generally more restrictions on what researchers can get away with.

This article was first published in the New York Review of Books.

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