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Deadly Medicine: FDA Fails to Regulate Rapidly Growing Industry of Overseas Drug Testing

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Pharmaceutical companies are increasingly conducting clinical trials for new drugs outside the U.S., usually in countries where regulations are less stringent and trials are much cheaper, often leading to deadly results. 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—many taking places in areas with poor and illiterate test subjects. Journalist Jim Steele joins to talk about his special investigation just published in Vanity Fair. [includes rush transcript]

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This is a rush transcript. Copy may not be in its final form.

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.

AMY GOODMAN: Jim, can you explain how you arrived at the number 200,000 people die a year from prescription medicine?

JAMES STEELE: Yes. There’s a nonprofit organization based in Pennsylvania called the Institute of Safe Medication Practices, and they have documented the figure of — I think it’s 19,500 individuals die roughly each — I think this was in 2008, 2009 — from prescription drugs. Any number of other studies have indicated this is a vastly understated number. That’s no reflection on the institute; they do very good work. But everybody agrees that that number is woefully below what the real number is. Most of the estimates have put the figure around 10 percent. We actually looked into this issue in great detail when we wrote a book on the American healthcare system several years ago. And most people who look at this in any depth have concluded that the reported figures represent about 10 percent of the actual total deaths. So we concluded, therefore, that you’re talking about 200,000 people dying pretty much yearly from prescription drugs. I mean, that’s more than die from diabetes and a whole range of other illnesses that affect people out there. So, it’s one of those unknown, really undisclosed and unpublicized killers that are the consequences of many prescription drugs.

JUAN GONZALEZ: One of the drugs you write about is Celebrex, which at one point I think —


JUAN GONZALEZ: — was bringing in about $3.4 billion a year in revenue to — was it Pfizer? And yet, you — could you talk about the problems that you uncovered, and then, in large part, the drug is barely used now?

JAMES STEELE: It is an anti-inflammatory drug used largely for people with arthritis. And when many side effects began to occur with many people, what was interesting to us is how slow the FDA was to react to this. The European Union began pulling it off the shelves over there. Even the Saudi Arabian drug agency pulled — I’m sorry, that’s another drug. But the European Union was one of the most instrumental in pulling the drug. Lawsuits began to be filed there and in this country. The FDA was very, very slow to react to that.

And now, of course, this drug is not really much of a factor at all. But it’s typical of how sometimes the rest of the world is much more attuned to this issue than we are. And that’s largely because the FDA is just so much in basically the grip of the pharmaceutical industry. I mean, one of the things that we didn’t even actually deal with in great detail in the story is, people think about the influence and they think about lobbying in this country. The lobbying isn’t Congress. In the case of the pharmaceutical industry, it’s heavily the FDA and Congress. And the numbers are absolutely staggering. It’s over 200 million a year that the industry shells out to lobby the agency and the Congress to make sure this system stays intact.

AMY GOODMAN: Can you give some examples of the drugs tested and where they were tested? You take a real global perspective on this.

JAMES STEELE: One of the ones that you mentioned at the beginning, Synflorix, was a drug to treat pneumonia and ear infections in children. This was treated — the clinical trial there was in a northern province in Arizona, where many of the parents were illiterate, where many of the children signed up at — the parents had no idea. They thought their children were actually being treated for the disease; they did not realize that it was an actual clinical trial. In fact, one of the local officials there was later found to be — who was conducting this, was later found to be, I think, the brother of one of the ministers of a particular state. That’s one area.

The former Soviet republics — Kazakhstan, for one, has been a real popular area. Many provinces in primitive areas. Rural areas in Romania have also been a real popular area. Rural sections of China, a couple provinces there have been real focal points of this. Extremely populated parts of India — New Delhi, for example, that I believe was also the test you mentioned earlier, that was also an area where folks have been subject to these tests. And what’s interesting to us is how these things are increasingly spreading out. In places like China and India, the appeal in those countries is — frankly, it’s jobs. If you’re a doctor in one of those places, the money you may make from signing up people to take these tests may will exceed your annual income from the rest of your practice, so that it’s a tremendous economic incentive in these countries to engage in these tests and to profit from them.

JUAN GONZALEZ: Jim, were you able to delve into how the choices of these places and the decisions to begin trials works out internally within these companies? Do they have brokers or people that out there scouting communities that they can utilize? Or are they giving bonuses to their various middle-level managers to find places where they can do these trials? How does it work?

JAMES STEELE: That’s a great question. And we did not get as deep into that as we wanted. But I’ll tell you what we did find. One of the greatest changes in the whole clinical trials field, both in this country and abroad, is the emergence of these — what we call a clinical trials industry. It’s the privatization of this process. It’s been another step in the whole movement toward sort of free market medicine, where they put the profit motive into this part of it.

In the past, so many of these clinical trials, both here and the few that were abroad, were conducted by, very often, academic institutions, medical schools, that conducted these. Increasingly in the last 10 to 15 years, you’ve seen the emergence of this whole new industry, profit-making companies that take the jobs from the pharmaceutical companies, and they say, "We will set up a clinical trial for you in India or China or some place in Africa or Kazakhstan, a rural area of Romania. We will find the people. We will find the doctor who will conduct these tests. We will pay them. You pay us in return." Then they render those results back to the pharmaceutical company. Now, we did not find immediate, direct evidence of this, but you don’t have to be a rocket scientist here to figure out that if you’re in the privatization business, you’re in the clinical trials business, you certainly want to deliver as favorable results as possible to the company, based on those trials you’ve conducted, or else, I suspect, you’re not going to get any new jobs in those places in the future. So, the whole emergence of this has put the profit motive into this segment of healthcare and medicine, and it’s really not healthy, because what you really need is an issue of science here, not people — not hedge funds, not private investors — trying to make a buck on this process.

AMY GOODMAN: I just want to — a quick correction. I think you said "Arizona" when you meant to say "Argentina," the testing of Synflorix.

JAMES STEELE: Argentina. Thank you very much. You’re absolutely right.

AMY GOODMAN: But finally, we’re going to be going on to Sid Wolfe of Health Research Group, who also has just released a report today. But the remarkable figure that you have that — what is the number of — in 2008, the FDA visited only 45 of 6,485 locations where foreign drug trials were being conducted? Forty-five of close to 6,500.

JAMES STEELE: Seven-tenths of one percent of the total foreign trials. I mean, this — so even if there were the regulations, even the little bit they do doesn’t go very far. And, of course, this is going to become a greater and greater problem, because we don’t fund government in any of its phases in this country, in many cases. And they have not funded the FDA in this particular area.

The other thing involved here is when these — in foreign trials and in foreign manufacturing of drugs, the U.S. inspectors need to get the approval of these foreign governments when they go into these places. And you can imagine what happens there. If somebody is tipped off, if you know somebody is coming, what kind of a normal inspection do you get there? So — and Joe Stephens mentioned this earlier — the U.S. is losing control of this process, and in many cases, there’s not a whole lot they can do on this. But at the bare minimum, they at least need to have a registry, they at least need to know where these are, and they at least need to step up the inspections that they can do. But right now there’s absolutely no will, no recognition of what a severe and really dangerous problem this is.

AMY GOODMAN: Jim Steele, I want to thank you for being with us, Pulitzer Prize-winning journalist, wrote with Don Barlett the latest piece in Vanity Fair called "Deadly Medicine." When we come back, we continue on this issue of drugs with Dr. Sid Wolfe. Stay with us.

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