Democracy Now: Deadly Medicine!

Deadly Medicine: FDA Fails to Regulate Rapidly Growing Industry of Overseas Drug Testing
July 31, 2012

JUAN GONZALEZ: To talk more about overseas drug testing, we’re joined by investigative reporter James Steele. He’s the co-author of a new article in Vanity Fair titled “Deadly Medicine.” The piece explores how pharmaceutical companies are increasingly conducting these clinical trials for new drugs outside the United States, usually in countries where regulations are less stringent and trials are much cheaper.

Twenty years ago, only 271 trials of drugs intended for use by Americans were conducted overseas. By 2008, the number had risen to nearly 6,500, an increase of more than 2,000 percent. Thousands of trials are taking place in countries with large numbers of poor, often illiterate, people who in some cases sign consent forms with a thumb print or scratch an “X.”

AMY GOODMAN: In some cases, the outsourcing of drug tests has been deadly. In Argentina, seven babies died while enrolled in clinical trials for GlaxoSmithKline. In New Delhi, India, 49 babies died at the All India Institute of Medical Sciences while taking part in clinical trials over a 30-month period.

Joining us in Philadelphia is investigative journalist Jim Steele. He wrote the article with his partner Don Barlett.

Welcome to Democracy Now!, Jim Steele. Welcome back. You have won virtually every major national journalism award, including two Pulitzer Prizes, two National Magazine Awards. The latest piece in Vanity Fair is called “Deadly Medicine.” Explain exactly the scope of your investigation, the companies involved, the countries where experiments are done, and what it has to do with the U.S.

JAMES STEELE: Well, first of all, it’s very good to be back with you both, and especially this program today. And Joe Stephens actually just hit the nail on the head when he said at the heart of this issue is that the U.S. loses control, the U.S. government loses control, in these foreign trials.

I think what surprised us the most about this whole story is that — there have always been some foreign clinical trials. That, on its face, is not new. What astonished us was the speed with which this has happened. The statistics that Juan quoted there at the beginning come from an inspector general’s report just released this last year. But the speed of this has actually accelerated very much in the last five to 10 years. It’s not just western Europe; it’s parts of the former Soviet Republic, it’s places in Africa, developing nations in Asia. But the two countries that are going to be at the heart of this more and more in the future are going to be China and India, which have both made this a priority. The Indians have revamped their laws to encourage the development of the clinical trial industry over there. China has made such a priority on teaching English that they’re going to be a big factor in this. You now have more people speaking English in China than in India, which I think was one of the things that surprised us about this whole story.

So, more and more of these are going to be moving abroad, as you mentioned earlier. Part of it is expense. And the irony of this is that at the same time it’s cheaper for the companies to go abroad, not just from the cost over there and the fact that there’s very little regulation, but it also is much more expensive for the U.S. to even attempt to have any oversight over there. Simply the cost of doing that kind of work abroad is much greater, even if there were the instinct and the desire to do that.

JUAN GONZALEZ: Well, Jim Steele, one of the things I noted in your article is that when you began talking about the FDA database of these clinical trials, that it’s wholly inadequate and is not even really tracking all the trials that are occurring, so that that would seem to indicate that some of these pharmaceutical firms could choose to hide the bad results of their clinical trials and only report the good ones.

JAMES STEELE: Absolutely. That struck us as much as any one fact in our investigation, that here you have a situation that when they start one of these trials somewhere, they don’t have to report that to the FDA. In fact, they can conduct it for years and not report it to the FDA. And then at some point they may decide, because the results are so bad or because there have been adverse events — adverse events, in many cases, means people have died, in drug company lingo — when that happens, none of this is reported to the FDA. The only time the FDA becomes involved is when they actually make — a drug company makes an actual formal application to get a new drug sanctioned.

But if you think about what research is about — trial and error, knowledge, things of that sort that researchers in so many other fields rely on the work of others, especially in this field, where people’s lives are at stake, where experiments may have gone awry — other companies should need to know that as well as the FDA, but that’s not even reported in this. The amazing thing about this to us is that not only are there no regulations really requiring them to report those trials, but even if there were, FDA has so few resources and so little will, it wouldn’t even be able to do any kind of effective monitoring of that.

So you have a situation here that’s totally chaotic. I mean, the FDA’s record of overseeing clinical trials in this country has not always been very good. But by these trials increasingly moving to places beyond the scope of the agency, where there’s no knowledge, where there’s nothing reported, now the agency is losing what little oversight and control it has. And the ramifications for the future, in terms of future drugs coming down the track, we think, are just potentially horrendous. (Read Full Texts)

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