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.

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DED