Help Wanted: Human Guinea Pigs
by Betsy Model, The Internationalist
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
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