Thursday, September 14, 2006
Guinea Pigs' Jobs Outsourced To India
Pharmaceutical companies are finding it more and more difficult to find
sufficient people to take part in Phase III clinical trials. Phase III is the
last step, and the longest, in bringing a new drug to market. One needs to have
a really large testing pool to weed out statistical anomalies. As such, it is
quite common for thousands, or even tens of thousands, of people to take part
in the testing.
In the Western World, depending on the illness or affliction, there are usually
few volunteers. Why? Patients are content to use existing treatments and
medication. Do you really want to try some unproven drug if the existing
treatment is 95% effective, just so that some pharma can verify it's claim of
96% efficacy? Of course not, so that's how
India enters
the picture.
Despite its burgeoning economy, India hasn't upgraded much of its
infrastructure. Access to good medical care (and prescription drugs) remains a
priviledge for those who can afford it. Doctors in India are being sold on the
idea of recruiting patients to take part in these drug trials. Apparently, the
Indians are ideal test subjects.
Many of these patients are also, in the delicate parlance of the
drug world, "treatment naive," meaning they've never taken any medication for
their illnesses. This is a perk for trial managers, because it lowers the risk
of unforeseen drug interactions and avoids the troublesome process of weaning
patients off one medication and onto another.
The patients get free (unproven) medication. The hospitals get x number of
dollars per test subject. The pharmaceutical companies get enough data points
for testing. A win-win-win scenario, right? Maybe. I guess it depends on if
they're taking Vioxx.
Bolding added by me.
Last year, the government took a more controversial step,
amending a long-standing law that limited the kind of trials that foreign
pharmaceutical companies could conduct. That law allowed companies to test drugs
on Indian patients only after the drugs had been proven safe in trials
conducted in the country of origin. In January, the government threw out that
constraint. India, the brilliant hub of outsourced labor, was positioning
itself in a newly lucrative role: guinea pig to the world.
Sounds scary to me, but that's capitalism in action. But it's not as if the big
health problems in India are heart disease, cancer, or osteoporosis. Those are
Western, middle-aged or older, ailments. Malaria and snake bites are much
bigger concerns.
I hate to say this, but just as it took the
Bhopal tragedy for
action to be undertaken against a neglectful chemical company, I think that it's
going to take a similar tragedy to occur in order to properly regulate drug
trials in India. The Indian government would be wise to ignore the money
streaming in and do something to protect its people before something
terrible happens.
\_/
DED
1 Comment:
- Mike said...
-
Wow. That's unbelievable. Good to see the caste system's gone in India.
- 9/15/2006 9:21 AM
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Name: DED
Location: United States
I'm a stay-at-home Dad who survived dotcom burnout and a
chemical engineering career that fizzled. While the kids are in school,
I'm free to write stories.
I'm a rational environmentalist, science and technology enthusiast, who leans
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