?Nation of guinea pigs?
There's a new outsourcing boom in South Asia with India becoming a global hub for drug trials, as reported recently.india Updated: Mar 05, 2006 20:22 IST
Its just not call centres anymore. According to the sci-tech magazine Wired, India is a nation of guinea pigs.
In its latest issue, the magazine has carried a report from the town of Sevagram in Central India where drug trials are being carried out.
The hospital is one of 28 in India recruiting stroke victims to try out German pharmaceutical company Boehringer Ingelheim’s latest stroke-prevention drug.
The drug regimen, known as Aggrenox, was apparently tested for its ability to forestall a second stroke. There magazine observed that the patients in Sevagram are very poor, so much so that the benefits of taking part in the study would amount to a health care windfall.
Among other things, Boehringer Ingelheim reportedly guaranteed participants two physicals during each of the three years that the trial would run. For each person enrolled, the hospital would receive Rs 30,000.
It is believed, by many in the pharmaceutical industry, that the solution to the slow pace of drug trials lies in outsourcing. Wired met up with Dr SP Kalantri, who heads the trial in Sevagram.
On being asked what treatment he gave to the stroke victim prior to the trial, he said, “Nothing. There's nothing we can do.”
Hemorrhagic strokes are reportedly untreatable -- drugs can't undo the damage. But Kalantri's lament was that patients are too poor to pay for medicine.
Because of this one alluring feature of a clinical trial is that patients are supplied with the test drug for free. And while the medication on offer isn't always said to be very useful, there's still the chance that it will do some good.
The drug trial experiment has three key stages- Phase I is when a compound is tested for safety on a handful of healthy people.
Phase II is conducted on a slightly larger group of mildly ill subjects while Phase III, the most extensive, involves thousands of subjects and takes up to seven years to complete. Phase III trials are the make-or-break point for new medicines and, because of their size, the hardest to fill with patients.
Wired reported that poorly-paid doctors can also find the financial rewards of a trial hard to resist -- particularly since pharma companies reward high enrollments with prizes like vacations to Hawaii and Europe.
"A lot of private hospital doctors have suddenly become ‘researchers,’" Kalantri reportedly states. "They will enroll almost anybody and recruit for almost any trial, whether or not it helps the patient."
And while the money earned from a trial in Sevagram goes to the hospital, elsewhere it may be paid to the doctor. "A lot", he is said to have observed, "goes into personal bank accounts."