Wednesday, July 27, 2011

Contract Research Organisations: CROs turn into human trafficking racket for drug trials

Syed Akbar
Hyderabad, July 23: Clinical research in the city has turned into a sort of human trafficking racket with Contract Research Organisations (CROs), which conduct drug trials on behalf of pharmaceutical companies, vying with one another in boasting of "large base of volunteers" ranging from 3,000 to
45,000 and offering "special population" for research.
The city has a little over 50 CROs and their combined "volunteers" registration is estimated at five lakh, mostly from socially and economically weaker sections. The CROs also take pride in their "control access" systems and ability to undertake studies for special population like the elderly, the obese, surgically sterile women, post-menopausal women, healthy women with child-bearing potential, and people suffering from defects in reproductive system. This in other words means practically every section of population, both healthy and suffering from diseases are readily available for quick research.
Some of them claim that they can keep the "volunteers" in their laboratories for as long as 28 days with strong checks on their movement. Some others offer trials on patient population too ranging from diabetics to those suffering from cancers. Interestingly, one CRO boasts of "readily available" diabetics as it has contacts with a leading hospital.
A website of a CRO claims that recently when a biotechnology company from the US needed 400 diabetics for a study, it began by heading to a nearby hospital specialising in diabetes, where a dozen new patients arrive every day and more than 40,000 are in its records.
"Our huge database of more than 27,000 volunteers which include 80 female volunteers and our ability to undertake studies for special population and unconventional molecules sets us apart from the competition," says a city-based CRO to its prospective clientele around the world.
Senior scientist Dr K Babu Rao said it's unethical to recruit volunteers on permanent basis and maintain a database of special population for quick enrolment whenever a pharmaceutical company comes up with a demand for exclusive research. "How can a CRO recruit volunteers in advance? It is ethically wrong and the drug administration should conduct raids on unscrupulous CROs and seize the database of volunteers for effective follow-up in case something goes wrong," he pointed out.
Another CRO proudly declares that it has a "volunteer mobilisation team" for clinical trials. "Vigilant screening and volunteer assessment methodology have created an extensive database of 47000 plus volunteers for studies," it says. Yet another CRO speaks of its volunteer database of  20000, that include healthy male and female, and post-menopausal women volunteers. 
"With an extremely large female volunteer database of about 500 we currently conduct a large number of female studies. Our large female volunteer database with our unique facility design enables us to conduct
mixed gender studies," says another CRO.
With the CROs resorting to unethical practices, the Indian Council of Medical Research has suggested compulsory registration of volunteers with the district authorities. "We will consider the proposal of compulsory registration of volunteers so that there's constant vigilance and if something goes wrong the volunteers can be traced," said ICMR director-general Dr VM Katoch.
Most of the CROs do not report adverse reactions to the Clinical Trials Registry of India and this makes the tracking of volunteers difficult. The government has acted only when volunteers lodged complaint with the police.
Hyderabad has been attracting multinational clinical trials as, phase I trials are about 50 per cent cheaper than western equivalents, while Phase II and Phase III are 60 per cent less expensive in the city.

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