Prescription drugs
kill some 200,000 Americans every year. Will that number
go up, now that most clinical trials are conducted
overseas—on sick Russians, homeless Poles, and
slum-dwelling Chinese—in places where regulation is
virtually nonexistent, the F.D.A. doesn’t reach, and
“mistakes” can end up in pauper’s graves? The authors
investigate the globalization of the pharmaceutical
industry, and the U.S. Government’s failure to rein in a
lethal profit machine. Photo illustration by Chris
Mueller. January 2011
Three
"markets" you've never heard of
More and more clinical trials for new drugs are being
outsourced overseas and conducted by companies for hire.
Is oversight even possible?
You wouldn’t think
the cities had much in common. Iaşi, with a population
of 320,000, lies in the Moldavian region of Romania.
Mégrine is a town of 24,000 in northern Tunisia, on the
Mediterranean Sea. Tartu, Estonia, with a population of
100,000, is the oldest city in the Baltic States; it is
sometimes called “the Athens on the Emajõgi.” Shenyang,
in northeastern China, is a major industrial center and
transportation hub with a population of 7.2 million.
These
places are not on anyone’s Top 10 list of travel
destinations. But the advance scouts of the
pharmaceutical industry have visited all of them, and
scores of similar cities and towns, large and small, in
far-flung corners of the planet. They have gone there to
find people willing to undergo clinical trials for new
drugs, and thereby help persuade the U.S. Food and Drug
Administration to declare the drugs safe and effective
for Americans. It’s the next big step in globalization,
and there’s good reason to wish that it weren’t.
A
2000% increase
Once upon a time, the drugs Americans took to treat
chronic diseases, clear up infections, improve their
state of mind, and enhance their sexual vitality were
tested primarily either in the United States (the vast
majority of cases) or in Europe. No longer. As recently
as 1990, according to the inspector general of the
Department of Health and Human Services, a mere 271
trials were being conducted in foreign countries of
drugs intended for American use. By 2008, the number had
risen to 6,485—an increase of more than 2,000 percent. A
database being compiled by the National Institutes of
Health has identified 58,788 such trials in 173
countries outside the United States since 2000. In 2008
alone, according to the inspector general’s report, 80
percent of the applications submitted to the F.D.A. for
new drugs contained data from foreign clinical trials.
Increasingly, companies are doing 100 percent of their
testing offshore. The inspector general found that the
20 largest U.S.-based pharmaceutical companies now
conducted “one-third of their clinical trials
exclusively at foreign sites.” All of this is taking
place when more drugs than ever—some 2,900 different
drugs for some 4,600 different conditions—are undergoing
clinical testing and vying to come to market.
The
lure of overseas drug testing
Some medical researchers question whether the results of
clinical trials conducted in certain other countries are
relevant to Americans in the first place. They point out
that people in impoverished parts of the world, for a
variety of reasons, may metabolize drugs differently
from the way Americans do. They note that the prevailing
diseases in other countries, such as malaria and
tuberculosis, can skew the outcome of clinical trials.
But from the point of view of the drug companies, it’s
easy to see why moving clinical trials overseas is so
appealing. For one thing, it’s cheaper to run trials in
places where the local population survives on only a few
dollars a day. It’s also easier to recruit patients, who
often believe they are being treated for a disease
rather than, as may be the case, just getting a placebo
as part of an experiment.
Finding "drug naive" patients
And it’s easier to find what the industry calls
“drug-naïve” patients: people who are not being treated
for any disease and are not currently taking any drugs,
and indeed may never have taken any—the sort of people
who will almost certainly yield better test results.
(For some subjects overseas, participation in a clinical
trial may be their first significant exposure to a
doctor.) Regulations in many foreign countries are also
less stringent, if there are any regulations at all. The
risk of litigation is negligible, in some places
nonexistent. Ethical concerns are a figure of speech.
Finally—a significant plus for the drug companies—the
F.D.A. does so little monitoring that the companies can
pretty much do and say what they want.
[Donald Barlett (born
July 17, 1936) is an American investigative journalist
and author. With collaborator James Steele, he has won
two Pulitzer Prizes, two National Magazine Awards and
five George Polk Awards. The duo are frequently referred
to as Barlett and Steele.]
