Drug companies take their trials overseas
Just as automakers and apparel manufacturers have fled the stringent labor and environmental laws of developed countries to set up shop in the developing world, pharmaceutical companies have streamed across borders in pursuit of warm bodies for the testing of new experimental drugs.
Drug giant GlaxoSmithKline has predicted that by next year more than half of its trials will be conducted overseas, a mark already hit by some of its competitors. In 2004 the U.S. Food and Drug Administration (FDA) estimated that drug companies angling for government approval of their products were launching more than 1,600 new foreign trials every year.
The most popular destinations are the broken, impoverished countries of Eastern Europe and Latin America. In Latin America, says Pfizer's Julio Camps, 'you can have fast recruitment . . . at a very reasonable cost.' Populations of patients no longer available in rich countries-those willing to swallow placebos and those who have never been treated for their illnesses-abound.
Pfizer's trial of the osteoporosis drug lasofoxifene, for example, required experimental subjects to be 'treatment-naive,' that is, never treated for the condition. Argentina was 'the number one recruiting site,' Camps said, calling the country's ability to provide willing guinea pigs 'amazing.'
Unlike human subjects in the United States and Western Europe, who frequently drop out of sometimes unpleasant clinical trials, Latin America's 'patient retention rates are nearly 10 percent better' than elsewhere in the world, according to the clinical-research trade publisher CenterWatch. And they do it for free: It seems that the provision of medicine, even experimental medicine, is sufficient.
The industry's new experimental bodies from poor countries rarely enjoy the benefits of the research they participate in. Sometimes the new drugs are unlicensed in their countries or priced out of reach. More often, however, the drugs are irrelevant to the health priorities of their communities to begin with. Overall, 90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world's diseases.
The tests also can violate the ethical standards that protect subjects in rich countries.
A case in point was a proposed 2001 trial for a drug aimed at treating premature babies with respiratory distress syndrome. Biotech drug company Discovery Laboratories, unable to find experimental subjects in the United States, planned to test its new drug through a placebo-controlled experiment in a poor hospital in Latin America. The company would give 325 deathly ill premature infants placebos instead of life-saving medicines widely available in the United States and Europe.
In the United States, where the FDA already had approved four similar drugs, such a trial would have been ethically and practically impossible. The drugs, after all, reduce mortality in lung-impaired infants by 34 percent. The company feared the new drug would prove no more effective than those of its competitors, and thus wanted to test it against a placebo. It wasn't that Discovery's drug would be much better; it would simply be easier to manufacture, and therefore cheaper.
The FDA discussed the proposed trial in a session titled 'Use of Placebo-Controls in Life Threatening Diseases: Is the Developing World the Answer?' The proposed subjects of the trial were poor and lacked access to the lifesaving medicines, the FDA reasoned, so the trial would pass muster-despite the 17 preventable deaths that Discovery estimated would result.
In that case, pressure from the watchdog group Public Citizen forced the company to redesign the trial. But generally, ethics violations pass unnoticed. 'For the most part,' acknowledged Gustavo Kaltwasser, who monitors trials in Latin America for the Olympia, Washington-based oversight body the Western Institutional Review Board, 'medical ethics committees [in the region] are not aware of . . . FDA regulations and ignore even their own country's regulations. They don't know it's in their power to suspend or terminate research or ask for more protection for subjects.'
John Climax, whose Dublin-based company, Icon, helps drug companies set up trials in Latin America, summed it up: 'You walk into a hospital in Latin America and immediately see this horrible place. . . . But from a clinical trial point of view, you can find patients and the doctors are excellent.' A gold mine for drug companies perhaps, but the export of clinical trials overseas is often an added burden on the sick and poor of the developing world.
Sonia Shah is the author of the new book The Body Hunters: Testing New Drugs on the World's Poorest Patients (New Press, 2006). Reprinted from NACLA Report on the Americas (March/April 2006). Subscriptions: $36/yr. (6 issues) from Box 77, Hopewell, PA 16650; www.nacla.org.
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