By Kelly Hearn,
Posted on June 9, 2006, Printed on June 9, 2006
A newly surfaced report alleges that in 1996, drug monolith Pfizer gave an unproven drug to Nigerian children and infants suffering from meningitis -- without the authorization of the Nigerian government. Completed five years ago and coming to light in a May 7 Washington Post investigation, the confidential report, written by a panel of Nigerian health experts, concluded that administering the drug Trovan to 100 patients suffering a deadly strain of meningitis was "an illegal trial of an unregistered drug." The drug was ultimately shown to be ineffective. A lawsuit against Pfizer claims some of the children in the trial died and others suffered brain damage.
The report surfaces as more and more clinical research relocates to the Global South in order to escape burdensome regulation schemes in the United States and Western Europe. AlterNet has obtained an early look at a book to be published later this year -- The Body Hunters: How the Drug Industry Tests Its Products On the World's Poorest Patients (New Press), by investigative journalist Sonia Shah -- that raises the curtain on a trend that's harming patients and health care systems while eroding the developing world's trust in conventional medicine.
Researchers needing patients and freer working conditions have for years found a honey pot in the world's slums and shantytowns. The fact that poor, desperate patients are willing to try anything, means companies like GlaxoSmithKline, Merck and Wyeth currently conduct 30 percent to 50 percent of their experiments outside Western Europe and the United States, and plan to boost foreign trials by 67 percent this year, according to USA Today. Their urgency is understandable; Shah's book notes that to get a single drug to market, drug companies are forced "to convince more than 4,000 patients to undergo 141 medical procedures each in more than 65 separate trials."
Clinical investigators and the companies backing them argue that overseas trials get drugs to a lucky few and lead to faster cures for us all. But Shah, the author of Crude: The Story of Oil, deftly takes that Big Pharma myth to task, tracing how drug trial exports ruin third-world health care systems, steer attention away from public health needs like clean water and sanitation, and ignore the health safety of subjects.
From the history of placebo controls to a modern map of how loophole-prone laws in the 1980s paved Big Pharma's easy way, Shah shows that "the main business of clinical research is not enhancing or saving lives but acquiring stuff: data" -- making it an industry instead of a social service, as it would have the world believe. As an industry, she argues, they should be denied the regulatory winks and nods reserved for a public health entity.
Hearn: What struck you as the worst case of excess or neglect you found while researching this book?
Shah: It was probably the trial I covered in Zambia [involving a drug to combat cryptosporidium, a diarrhea-causing infection]. It was stark, children dying, little kids dying. But from what I can tell if these kids had received antiretroviral therapy they could have survived. But they were put into a trial for a drug that never benefited them or their families or siblings because the drug was so completely targeted for other populations, almost a luxury drug for fighting an infection that in Western children means a day of diarrhea. It is so mild in kids who are healthy that lots of people don't even notice it.
So for such a minor condition they tested the drug on people who were so, so sick. And in the end, 12 kids died.
Kelly Hearn: You write that by the late 1990s, pharmaceutical companies had grown frustrated with the pace of academic hospitals and research centers, and changed the contracting focus to "contract research organizations," private companies that promise to get drug trials done quickly. What role do these companies play in the scheme of drug trials, and to what degree are they responsible for the growth in overseas trials?
Sonia Shah: There are two things, a push and a pull, that force trials overseas. The push is a patient recruitment bottleneck. Most trials don't meet recruitment deadlines, whether it's because Americans aren't interested or their profiles are wrong. Often the right kind of patients don't exist in enough quantity in the U.S., or if they do they drop out of trials.
The big pull is the contract research organizations (CROs). If anyone is a body hunter, it's the CRO industry, an industry that has largely escaped public notice, perhaps because of the weird, vague sounding moniker, CRO. Public Citizen called them, more accurately, "human experiment corporations." They are, though, just a business, and are not any more venal than other actors involved.
Hearn: Like you, many journalists and health experts I have interviewed almost invariably say the FDA should require new drugs to outperform existing ones rather than simply work better than a placebo. Given your sense of the FDA's ruling culture, the growing public frustration with drug companies, Washington's current political climate, and so on, is there real hope of this happening in the next few years?
Shah: I think not. But the history of regulation goes in fits and starts based on scandals, horrible mistakes like thalidomide, and then regulations change rapidly. And we can't predict disasters, something that will come into the limelight and expose a controversy, something that can change headlines. The FDA is vulnerable to headlines, to politics.
Hearn: What are the most dangerous structural impacts overseas trials can have on developing countries' health systems?
Shah: The main thing is misallocation of resources. You're talking about such a scarcity in terms of clinics, nurses, doctors, facilities, medicine, tools and time. You have places where all this is in short supply and in that setting they have this fruit dangled in front of them -- we'll pay you so many hundreds per patient, we'll give you new technology, new MRI machines, etc.
But what this means is that doctors and nurses there are performing experiments for treatments for things like diabetes, arthritis, erectile dysfunction. These things are important in the West but these people have malaria, cholera, and other infections. In that sense, the industry sponsored trials are distorting health care.
Part of a larger trend, as is happening in places like India that have and want more foreign trials, is the rise of privatized, two-tiered health care where high-tech facilities and highly specialized physicians are available for the wealthy, but the poor just have basic service that they have to pay for. In India and in South Africa, they are building hospitals not for people who live there but for foreigners. Doing trial business is part of the trend toward creating two-tiered systems in these countries, a private one for the rich and nothing for the poor.
Hearn: You talk about the phrase "due to ethical concerns" appearing frequently in biomedical conversations. You note that it is almost "exclusively reserved for biomedical transgressions." Can you explain?
Shah: It's just that you never hear it outside these circles it seems. If you're talking about something unethical, you don't say, "It's not possible due to ethical concerns." You don't say, "It's not possible to gas people due to ethical concerns." You say, "Such and such happened, and it was wrong, immoral and illegal."
Hearn: Rep. Tom Lantos of California said after the Washington Post's coverage of the Nigerian report that he will offer a bill making U.S. researchers give federal regulators details of tests planned in developing countries. What do you think of that idea, and what are some of the necessary regulatory changes for reining in the transgressions you address in the book?
Shah: I think it's a baby step in right direction. But most important, there needs to be restraints and breaks in the exportation of drug trials. It's not possible to put in enough oversight to protect these subjects, at the present time. Restraint is necessary. I was giving a talk at the FDA, and the regulators wanted to know what they can do to make it better. What about a new rule that says there should be an ethics committee review in this country and the country taking the trial? That's already true for NIH trials.
That would be good, but we know from NIH trials that lots of things fall through cracks, and that just requiring the ethics review is not sufficient. Another thing you could do is require verification of informed consent and really make sure people understand what's happening, that they fill out forms or take quizzes to show they understand.
Hearn: You put hope into the rise of the nonprofit drug companies. What are some of the key ways they can help?
Shah: I don't think it's wrong to do trials in developing countries. It's about what kind of drugs that are being developed. Are the drugs a public health priority? Those who take on the burden of experimentation should enjoy the fruits of research rather than watching the benefits go only to a tiny percentage of white, overweight bald men.
Hearn: Having now written about two of the world's most powerful interests, Big Oil and Big Pharma, what common themes emerge?
Shah: What's interesting to me is they produce commodities that are public goods. Society needs energy and medicine, but we let private companies do it for us. And their goals are to enrich shareholders. We need these things, but we decide the responsibility for providing it should go to for-profit entities. This develops all kinds of distortions.
Kelly Hearn is a former UPI staff writer who divides his time between the United States and South America. A correspondent for the Christian Science Monitor, his work has appeared in The Nation, The American Prospect and other publications. He is a regular contributor to AlterNet.