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.
Conditional Love
Parents who conceive
biologically have to leave a baby’s sex up to nature. Adoptive
parents, however, sometimes get a choice, and when they do, some 80
percent of them pick girls, leaving long waits for boys who need
homes. According to Adoptive Families (March/April
2006), rationales vary: Families that already have boys frequently
want to adopt a girl, while families with girls tend to want to
keep the peace with another girl. Many adoption agencies won’t
accommodate a sex request and are uncomfortable placing a ‘second
choice’ child with a parent who has expressed a strong preference.
In the end, most parents who thought they had a preference don’t
know they’re putting boys at a disadvantage and don’t care what sex
the baby is once it reaches their doorstep. ‘There was a little boy
waiting for us,’ one parent told Adoptive Families, ‘and we loved
him so much. Having a girl seemed much less important than adopting
this child.’
