Indians turn world pharmaceutical guinea pigs.

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Indians turn cheap guinea pigs for foreign firmsThursday, 29 September , 2005,

09:31

By Jay Shankar in Bangalore

 

 

 

Lured by the money being offered by the dozens of global pharmaceutical firms

doing clinical trials in India, human guinea pig M Mahesh, is testing his sixth

drug -- this time helping in the search for a cure for asthma.

 

Dressed in chequered green hospital dress and wearing a badge bearing his

photograph and a number, Mahesh, a welder, has no inkling at all about the drugs

he has allowed doctors to introduce into his body over the past two years.

For now he has no regrets. " So far no drug has had an adverse impact on my

health. I will continue to do this for the money I get, " 27-year-old Mahesh

tells AFP, disclosing that for the lastest test he will be paid Rs 5,000 by the

research firm.

 

" It is the sixth time that I am testing a drug on myself, " he adds. " They

(officials of the firm) briefed me in local language about the side-effects of

the drug. "

Mahesh and and his friend Bala Kumar are among more than a dozen volunteers

staying at a " Subjects Housing " room at the Bangalore facility of Lotus Labs

Private Limited, a fully-owned subsidiary of Iceland-based Actavis, which is

engaged in clinical and drug research.

 

Thousands of volunteers like them are driving India's nascent clinical research

industry, which has attracted global pharmaceutical firms such as Aventis, Eli

Lilly, GlaxoSmithKline, Novo Nordisk, Novartis, Pfizer and Sandoz.

According to a report by consultants McKinsey and Co., the Indian clinical

research industry can earn revenues of $1.5 b by 2010, at which time the country

will need 50,000 professionals and about 300,000 " subjects " or patients.

 

Critics say the country's s huge illiterate population is in danger of being

misused by unethical firms to test suspect drugs. But industry officials say

each trial follows a strict code of ethics.

 

" The volunteers undergo health tests such as blood, urine, chest X-rays and

heart check-up. If they fail we do not enroll them for the test, " says Sandhya

Ravi, chief of clinical services of Lotus Labs.

" A detalied presentation on the side-effects of the drug are made to these

volunteers. Their consent is also taken, " she says. " Blood samples are collected

about 21 times during the testing, which varies from 36 hours to 72 hours. A

drug wash-out period of 90 days is strictly adhered to. So these volunteers

cannot enroll for testing for the next three months, " she said.

 

" Strict protocols for safety are followed and the trial is monitored by an

ethics committee comprising doctors, lawyers and even housewives, " Ravi says.

Under Indian laws, only testing of new and generic drugs, which have gone off

patent and are manufactured in the country are permitted, and on healthy

volunteers. All pre-clinical trials other than on rodents are banned.

 

But as soon as pre-clinical trials on animals are over in a foreign country and

the new drug has been tested on healthy volunteers in that nation, the drug can

be used in India for so-called second and third phase trials.

 

Clinical research organisations recruit volunteers through newspaper

advertisements or word-of-mouth. Industry officials say it costs upwards of one

billion dollars to make a new drug, with clinical trials accounting for almost

two-thirds of the cost.

 

In India the trials can cut costs by more than 55 per cent due to cheap and

skilled scientific manpower and availability of abundant volunteers.

 

 

 

source: http://sify.com/news/scienceandmedicine/fullstory.php?id=13951825

 

 

 

 

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