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 the border in pursuit of warm bodies for the testing of new experimental drugs.
By 2006, GlaxoSmithKline, Wyeth and other drug giants predict that half or more of their trials will be conducted overseas. In 2004, the U.S. Food and Drug Administration (FDA) estimated that drug companies angling for FDA approval of their new products were launching over 1,600 new trials overseas every year.
The most popular destinations are not Western Europe and Japan, but rather the broken, impoverished countries of Eastern Europe and Latin America. In Latin American countries, 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’ve never been treated for their illnesses—abound in the developing world.
Pfizer’s trial of the osteoporosis drug lasofoxifene, for example, required the experimental subject to be “treatment-naïve,” that is, never treated for their conditions. 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% better” than elsewhere in the world, reported clinical-research trade publication CenterWatch. And they do it on the cheap, too. “In this region,” adds CenterWatch, “subjects are not compensated for their participation.” The provision of free medicine, it seems, even experimental, is sufficient.
What’s more, 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% of the global medical research budget takes aim at illnesses that cause just 10% of the world’s disease burden. The tests can also 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 (RDS). 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—Bolivia, Ecuador, Mexico and Peru were mentioned as potential sites. In the experiment, the company would give 325 deathly ill premature infants placebos (salt water or air) instead of life-saving medicines widely available in the United States and Europe. In the United States, where the FDA had already approved four other similar drugs, called surfactants, such a trial would have been ethically and practically impossible. The drugs, after all, reduce mortality in lung-impaired infants by 34%. Since the company feared their new drug would prove no more effective than those of its competitors, they wanted to test it against a placebo. It wasn’t that Discovery’s drug would be much better, but that 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 would follow. In that case, pressure from watchdog group Public Citizen forced the company to redesign the trial. But generally, in cases such as these, ethics violations pass unnoticed. “For the most part,” admitted Gustavo Kaltwasser, who monitors trials in Latin America for a Seattle-based oversight committee, “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.”
According to Argentina’s National Ombudsman office, 17 trials of cancer drugs conducted between 1998 and 2002 failed to secure official authorization or informed consent from subjects. “Informed consent does not get on well with our culture,” explained one oncologist, who spoke to a Reuters reporter on condition of anonymity. “The lack of official control makes our country attractive to do experimental research without observing the human rights of patients,” added Manuel Limeres, the head of Argentina’s clinical-trials regulatory agency.
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. It doesn’t look clean. It looks inundated by patients and there aren’t a lot of places to sit. The building may look unimpressive, and the standard of medical care may seem different than in the West.
“But from a clinical trial point of view, you can find patients and the doctors are excellent.” A goldmine 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.
About the Author
Sonia Shah’s new book The Body Hunters: Testing New Drugs on the World’s Poorest Patients is forthcoming from The New Press in July. 2006.
