The Outsourcing of Health

The outsourcing of drug trials-

Many of today’s trials still take place in developed countries, such as

Britain, Italy, and Japan. But thousands are taking place in countries with

large concentrations of poor, often illiterate people, who in some cases

sign consent forms with a thumbprint, or scratch an “X.” Bangladesh has been

home to 76 clinical trials. There have been clinical trials in Malawi (61),

the Russian Federation (1,513), Romania (876), Thailand (786), Ukraine

(589), Kazakhstan (15), Peru (494), Iran (292), Turkey (716), and Uganda

(132). Throw a dart at a world map and you are unlikely to hit a spot that

has escaped the attention of those who scout out locations for the

pharmaceutical industry.

The two destinations that one day will eclipse all the others, including

Europe and the United States, are China (with 1,861 trials) and India (with

1,457)."

It does no good to anyone, of course-

"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.

With possibly terrible, lethal consequences-

One big factor in the shift of clinical trials to foreign countries is a

loophole in F.D.A. regulations: if studies in the United States suggest that

a drug has no benefit, trials from abroad can often be used in their stead

to secure F.D.A. approval. There’s even a term for countries that have shown

themselves to be especially amenable when drug companies need positive data

fast: they’re called “rescue countries.” Rescue countries came to the aid of

Ketek, the first of a new generation of widely heralded antibiotics to treat

respiratory-tract infections. Ketek was developed in the 1990s by Aventis

Pharmaceuticals, now Sanofi-Aventis. In 2004—on April Fools’ Day, as it

happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s

decision was based heavily on the results of studies in Hungary, Morocco,

Tunisia, and Turkey.

Read more of this great article at Vanity Fair