Bioequivalence and Bioavailability Forum

Dear colleagues,

just read an interesting article (Shivrath's Monthly News letter, December 2009, p.3-4), which I want to share with you:

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CLINICAL IRONY: DRUG TRIALS FUNDING HOOCH DOSE

December 22nd, 2009

Ahmedabad: That life-saving drug you are taking may have a bizarre link with deadly hooch: scores of young men in Sanand are voluntarily taking part in clinical trials of new medicines just to finance their hooch dose.

Mayank Chavda (not his real name), who is in his 30s, has often had new drugs tested on him. Chavda is a hooch addict and a resident of Makhiyav village in Sanand; he says clinical research organisations (CROs) pay well for taking part in trials.

Indeed, sources in the know ofthe testing processes said that volunteers are paid at least Rs10,000* per trial session, which typically lasts around four days. Generally, people are subjected to screening before being brought on board as volunteers. There are 10 CROs in Ahmedabad, and their total bed capacity is 1000.

"I have visited all the drug-testing centres across the state," Chavda said. "One gets paid only after completing an entire session." He said drug companies pay for the volunteers' accommodation. "They also reimburse travel expenses," he said. "Besides, you are paid for each session, and that is easy money."

The movement between a hooch den and a trial lab is most evident in areas in and around Sanand. For many unemployed youth, clinical trials are the means to basic sustenance. Harish Chauhan (name changed), who runs a CD shop near Sanand said drug testing had almost become a cottage industry for the youths in the area. "Many of my friends have visited these centres," Chauhan said.

"The trials allow young unemployed people to contribute to their household income. But some use the money to support their hooch habit."

Chauhan told DNA that he himself had been through a number of tests. "I have tried various drugs on myself, including tablets for headaches and obesity problems," he said. "I stopped doing it a year back after I became financially secure."

As for the dangers, such as side-effects, Chauhan said people were wholly aware of the risks.

"It is a voluntary act and nobody forces people to test the drugs. So nobody can be blamed for the trend," Chauhan said.

The former president of Ahmedabad Medical Association, Dr Mukesh Shah, said that there was nothing unethical about drug testing. He said, "The intention of some of the volunteers is flawed. The problem is that some illiterate people agree to test drugs when they run out of money."

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(Original emphases; Hooch aka Moonshine)
* 10,000 INR = 150 € = 215 $ as of today