Globalizing Clinical Research
By the end of July a US district court will decide whether drug giant Pfizer should stand trial in the United States for presiding over a coercive, botched 1996 experiment on Nigerian children with meningitis. In a class-action suit filed last August, thirty Nigerian families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis and death as a result.
If allowed, the case will open a rare window on a business generally shrouded in FDA and Big Pharma secrecy: the global commerce in human experimentation. Over the past decade, the drug industry has quietly exported its clinical testing overseas, where oversight is slim and patients plentiful. According to a largely unnoticed Health and Human Services (HHS) report, the number of foreign investigators seeking FDA approvals increased sixteenfold between 1990 and 1999. The actual numbers are probably much higher--companies aren't required to alert the FDA before taking their research overseas, nor does the FDA track research by location after approving new drugs.
Globalizing clinical research solves the pharmaceutical paradox that while the average American brings home more than ten prescriptions a year, just one in 350 is willing to play guinea pig for new drug testing. An abundance of poor, undertreated and doctor-trusting patients in Eastern Europe, Latin America and Southeast Asia renders the quick, positive results corporate sponsors need to get new drugs approved fast. According to one review, a whopping 99 percent of controlled trials published in China bestowed positive results upon the treatment under investigation.
Although the HHS report found that the "FDA cannot assure the same level of human subject protections in foreign trials as domestic ones," industry officials say that companies have little interest in bending the rules. "Occasionally things go wrong," allows Pharmaceutical Research and Manufacturers of America official Caroline Loew. But generally speaking, she says, "companies that are investing $800 million in every single drug are not going to waste money on trials that don't meet [the FDA's] exacting standards." Loew says that companies test new drugs abroad so they can sell them to needy foreign patients.
Analysts disagree. "There may be a market" in some developing countries, says Tufts University's drug-development expert Kenneth Kaitin, "but they are really interested in the United States, Europe and Japan," which dominate more than 80 percent of the global drug market. Indeed, all this foreign experimentation can hardly be counted on to develop malaria vaccines or cure multidrug-resistant TB. "The diseases that are of most interest are mainly the degenerative diseases--arthritis, obesity, heart disease--the diseases of people in the developed world," says South African bioethicist Dr. Solomon Benatar.
Just 0.3 percent of the drug industry's much-touted R&D resulted in the handful of drugs approved for tropical diseases between 1975 and 1997, despite tens of thousands of industry-sponsored clinical trials conducted around the world every year. Currently, US companies are investigating treatments for oral cancer in China, lupus in Mexico and severe short stature in Eastern Europe, among other studies--not exactly a list of the world's most pressing public health problems.
Even if Americans were willing to participate in trials, they take so many medications that they make poor lab rats anyway, clinical researchers say. To prove a new drug safe and effective, "you want patients with no other disease states and no other treatments. Then you can say relatively clearly that whatever happens to those patients is from the drug," says MDS Pharma's Simon Yaxley, whose company sells what industry PR folks call "patient recruitment solutions" in Eastern Europe, South Africa, Latin America and China. In developing countries, many people, because they are poor and don't have access to clinicians and hospitals, aren't taking any medicines for their illnesses.
Not only do experiments on such patients yield clearer results, but recruitment is rapid. "Say you need 1,000 patients in your trial. If you tried Western Europe, it would take you a long time to find untreated patients," Yaxley says. In a developing country, "you might find those patients in half the time." After all, "the healthcare systems aren't as sophisticated," he adds, and "because of that, there is an increased interest in accessing drugs via clinical research, and therefore we can leverage that interest." Indeed, consumer health advocates say that clinical trials are the only way some poor patients can get any formal healthcare at all.