200,000 people dying yearly from prescription drugs
Pharmaceutical companies are increasingly conducting 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.”
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.
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.
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, 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 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. 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.
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.
Celebrex brought about $3.4 billion a year in revenue to Pfize. 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. 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.
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 Argentina, 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, 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.
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 hedge funds, not private investors—trying to make a buck on this process.
In 2008, the FDA visited only 45 of 6,485 locations where foreign drug trials were being conducted
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.
Discussion with Jim Steele.
Jim Steele, two times Pulitzer Prize, two National Magazine Award winner journalist. His latest piece in Vanity Fair is called “Deadly Medicine.”