Help Wanted: Human Guinea Pigs

by Betsy Model, The Internationalist

http://www.alternet.org/, May 9, 2007

If you've ever wondered why we so rarely hear of drug trials going awry in the United States, it is because we "offshore" the drug trials to developing nations who can't afford to say no.

If you've ever wondered why we so rarely hear of drug trials going awry in the United States, Sonia Shah, author of The Body Hunters: Testing New Drugs on the World's Poorest Patients (The New Press, 2006), has the unattractive answer: we "offshore" the drug trials to developing nations and to those who simply can't afford to say "anywhere but here."

Betsy Model: You've said that multi-national pharmaceutical companies are exporting their clinical trials to countries like Asia and Africa not just for cost savings and the ultimate profitability of the new drug, but because ethical oversight is minimal and it's easier to find large quantities of willing test participants. Why is that?

Sonia Shah: Recruiting subjects for drug trials has become the number one bottleneck in drug development in Western countries. The more proven drugs we have available to us, it seems, the less willing we are to play test subject for experimental ones. In countries where sick, untreated patients are abundant, the opposite is true. So recruitment into trials is rapid, and drug companies save money and beat their rivals to market. It's good business.

Are you suggesting that there is a "something is better than nothing" mentality when it comes to testing potentially harmful or fatal drugs or drug regimens on the poor in third world countries?

Yes. Many people in the clinical trials industry argue that "Look, these people are not getting any care at all. At least we're experimenting there so that some of them can get something. It's better than nothing. It's not like people in Malawi are developing their own pharmaceutical industry...they still need the predominantly Western, multi-national drug industry to make medicines for them. They're lucky they're getting this little crumb we're giving them."

So, the rationalization or reading on the practice is that "everyone benefits?"

That's definitely a common argument within the clinical trials world. It's a self-interested misreading because nobody can guarantee that an individual subject will benefit in an experimental trial. There's uncertainty there -- that's why it's an experiment.

If you send a crappy job somewhere in a third world country, even if it's a terrible job and the pay is only a dollar a day, you know in the normal course of things that anyone who goes to work there is going to make their dollar each day. They're going to get that benefit, however slim it is. That's not true in a clinical trial. You can say that overall, only 5 percent of patients are going to have XYZ side-effects but for that one individual person you can't say for sure that they will benefit. They're not going to get that equivalent of one dollar a day. They might get nothing, they might get injured for life. They might be part of a control group and only get placebos.

So, if someone dying from HIV/AIDS, for example, is getting placebos, how can we argue that that one individual somehow benefits during a drug trial?

Many researchers believe -- and even Robert Temple, medical director of the FDA, has said -- that even the people in placebo groups fare better in a trial because outside the trial they're not getting medicines or any kind of health care at all because they're too poor. At least in a trial, they'll have a clinician meeting with them, and will get care for whatever ailments they might have that are secondary to the trial. It's a crumb, which is better than nothing.

"The Constant Gardener," the 2005 movie based on John Le Carré's best-selling novel, depicted the pharmaceutical companies and the clinicians who were administering the tests in developing nations as being quite unwilling to speak on the record as to the safety of trials. In fact, in a forward to your book, Le Carré referred to your book as an "act of courage." Did you ever feel intimidated when asking people to talk to you?

No, on the contrary. The book and the movie needed that drama to sustain the plot -- which I understand completely -- but the idea that the clinicians involved in these trials are deeply ashamed (or) that they consider what they're doing wrong or exploitive isn't really true. The people on the ground doing these trials have been put into a situation where even though it might perhaps be an unethical trial, they're doing the right thing for their patients at the time.

Were there any surprises in how your research and book have been received by the American public?

The response I wasn't prepared for was people asking me "What's the big deal? We send our dirty, toxic sweat-shop work to factories in China and Asia and Latin America and twelve year-old girls work there and we're okay with that, right? That's globalization. How is this any different? If people need medicine and this is their only way to get it, what's the big deal?"

It's ironic, because all our ethical principles assume otherwise. The first principle for an ethical trial is that trial subjects give informed and voluntary consent. They shouldn't feel forced into it. There's no such standard for a sweatshop job.

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