Globalizing Clinical Research
The trial would have remained Pfizer's dirty little secret had the Washington Post not unearthed it in a late 2000 investigative series. The sensational, John le Carré-like story of coercive experimentation brought thousands of Nigerians into the streets, launching belated Nigerian and FDA inquiries. In a flurry of outrage, US Representatives Tom Lantos and Henry Hyde sponsored a patient-protection amendment to the Export Administration Act, which would make it more difficult for companies to export experimental medicines abroad.
But Pfizer stands by its study. On its website the company argues that given the impoverished, squalid conditions Pfizer found in Nigeria, patients ought to have deemed themselves lucky to get the cutting-edge medical care and upgraded local facilities that Pfizer's trial offered. "Overall medical care substantially improved due to the presence of this clinical trial," Pfizer says.
This specious argument, that "whatever we do is better than nothing," as Nigerian physician Alphonsus Obayuwana put it, underpins ongoing attempts to rationalize shoddy treatment of poor patients in developing countries. In January 2001, for instance, as part of a trial of a new drug, Discovery Laboratories planned to administer saltwater or air placebos to 325 deathly ill premature infants--arguing that in the poorly equipped Latin American hospitals where the trial would be conducted, patients couldn't afford effective drugs anyway. Discovery admitted to the FDA that its new surfactant drug, called Surfaxin, probably wouldn't improve upon any of the four surfactants the agency had approved since 1990, according to internal FDA documents procured by Public Citizen. But however marginal Surfaxin's contribution to patient care, the drug would be easier to manufacture, the company says. Since the FDA only requires that new drugs prove effective--not more effective than already approved drugs--Discovery planned to seek FDA approval by showing that Surfaxin was better than nothing. The problem of finding parents of dying infants desperate enough to risk being assigned to a placebo group could be overcome by exporting the trial to impoverished Latin American hospitals, "where other drugs in its class are approved, but not standard of care because of financial limitations or government rationing," FDA officials explained in an agency review of the study.
After Public Citizen stepped up pressure, the company redesigned the study without placebos in April 2001, but FDA medical policy associate director Dr. Robert Temple, who participated in an agency review of the study, defends the original study design. "At present nobody in the places where the study would have been done is getting surfactant," he told me. "If they did, the trial half of the people would get surfactant and better perinatal care, and the other half would get better perinatal care. It seems to me all the people in the trial would have been better off." Indeed, Public Citizen's Lurie says, Discovery intended to upgrade research sites to the standards of a Western intensive-care unit--"they just wouldn't squirt active drug down the tube."
The international health advocates one would expect to mount a noisy campaign against shoddy corporate trials have been surprisingly muted. There's a certain wariness about imposing impossible demands and idealistic ethical standards on companies that can easily take their business elsewhere. Doctors Without Borders, the WHO and other international health organizations have made increasing corporate research interest in the Third World a primary goal, making critiques of such trials secondary, at least for now. "It takes half a second to look at how much more burdened the developing world is with ill health and disability. What we need, if anything, is more health research in the developing world, not less," says Johns Hopkins bioethicist Ruth Faden. Plus, even when companies aim for rich Western consumers, testing new drugs on poor patients "brings benefits to the patients. They get special attention and potential therapy," adds HIV researcher Arthur Ammann, who has tried to convince drug companies to run more trials in developing countries.
Watchdogs like Public Citizen's Health Research Group vociferously decry unethical study designs but can do little to police study conduct, which both the FDA and the drug industry view as secret, "proprietary" information. Ethics documents issued by international associations such as the World Medical Association and the WHO/UNESCO's Council for International Organizations of Medical Sciences, as important as they are, are alarmingly toothless. Pharma companies themselves have attempted a voluntary "harmonization" of clinical research standards abroad to meet FDA standards but, not surprisingly, such efforts are frighteningly nascent in many developing countries.
In the end, such voluntary endeavors, while crucial, are hardly sufficient to protect the would-be guinea pigs of the world sacrificed on the altar of Big Pharma profit. The IRB reviews, FDA approvals and the like that protect patients at home need to be not only universal but mandatory. With any luck, the class-action suit against Pfizer will strengthen the argument for such protections--at least until the gap between Western elites glutted on the latest medicines and a world majority lacking access to simple antibiotics somehow begins to close.