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A Times Editorial

As risk from drugs grows, FDA sleeps

Americans may have thought they knew what the final testing stages of a new prescription drug looked like. White-lab-coated doctors and technicians informing drug trial participants of their rights followed by careful monitoring and objective analysis of results. While this may be true for human drug testing in the United States and other developed countries, St. Petersburg Times staff writer Kris Hundley found that for poor and powerless test subjects in India those basic standards are often ignored, threatening not just their health but also that of Americans. The situation is the result of nothing less than an abdication by the U.S. Food and Drug Administration.

Indian test subjects sign up for drug trials because they have little access to modern medicine and because the pay is so big relative to the pittance they earn. Drug companies use the data drawn from such trials in India when they seek approval from the FDA for new pharmaceuticals. But Hundley's reporting showed the trials included shoddy research methods, underreporting of adverse side effects and ethics committees compromised by financial incentives. That translates into corrupted data and the potential for dangerous or ineffective drugs to end up on America's pharmacy shelves.

For example, Hundley interviewed Maheshbhai Macwana, who said he had participated in a half-dozen studies, selling his body over and over again for experiments out of financial desperation. But there are no effective systems in place to ensure that he is not overlapping the experiments and affecting the data.

It should be remembered that the U.S. pharmaceutical industry used the pretense of protecting American consumers when Congress was debating whether to allow brand-name prescription drugs to be reimported from Canada. Big Pharma issued hysterical warnings about how perilous it would be for Americans to buy drugs from abroad — how the drugs could be contaminated or counterfeited by Canadian pharmacists. Of course, the industry's true concern was how reimportation would impact its profits, since Americans have been able to buy drugs across our northern border at discounts of as much as 30 to 50 percent.

Now these same companies are lining up to do drug trials in some of the world's poorest places where, as Hundley reports, "every layer of oversight is compromised by cash." It is an approach that ensures quicker clinical trials at cheaper prices — without regard for the compromised safety.

Where is the FDA in all this? Sleeping and understaffed. Out of the hundreds of drug trial sites in India, the FDA has inspected eight in the last three years. Mike Leavitt, secretary of the Department of Health and Human Services, says there are plans to open two FDA offices in India soon. But at this point it appears that the Western pharmaceutical companies are essentially left to police themselves.

President-elect Barack Obama's administration will need to find a way to patch this gaping hole in our nation's health and safety. And if the FDA doesn't quickly ramp up its capacity to properly audit drug trials in developing countries, then effective limits need to be placed on them.

Outsourcing a consumer help line to India is one thing. It's quite another to outsource the process of testing prescription drugs to a country where two-thirds of its 1.2-billion people live on less than $2 a day and corruption is endemic. Without a truly independent monitor, there is no confidence that test results aren't being skewed. And there is every chance that the health of American patients will be jeopardized. It may take years before we know how broken the system truly is and the extent of the damage caused.

As risk from drugs grows, FDA sleeps 12/16/08 [Last modified: Thursday, December 18, 2008 4:39pm]
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