Tuesday, June 15, 2010

[ZESTCaste] Dalits used as guinea pigs for drug trials in Khammam

http://epaper.timesofindia.com/Daily/skins/TOINEW/navigator.asp?Daily=TOIH&showST=true&login=default&pub=TOI&AW=1276577330656

Dalits used as guinea pigs for drug trials in Khammam

G Arun Kumar | TNN

Hyderabad: Khammam district has turned into a 'pharma lab' with Dalits
being used as guinea pigs by drug companies to test their medicines,
thereby endangering their lives. While the SC/ST community and tribals
are lured with money ranging from Rs 8,000 to Rs 10,000,
agents/brokers act as facilitators for the pharma companies.
  Recent clinical
trials by a Hyderabad-based research agency in the tribal areas of
Khammam have turned out to be dubious since the participants in the
study were not well informed about the consequences of the drugs
administered to them. Consequently, a majority of them have complained
of severe body pains, giddiness and other side effects. The affected
people hail from seven villages in Charla and 20 in Bhadrachalam
mandals.
  Highly-placed sources told TOI that over 300 people were tested for
drug reaction. Drugs such as 'Amlodipine Besylate' (to control
hypertension) and 'Atorvostatin' (to fight cholesterol) were
administered to more than 100 people belonging to SC/ST communities in
Charla mandal with the help of volunteers of the research agency.
  The experiments were being carried out in Danvaipet, Ambedkarnagar,
Vijay Colony, Meduvai Colony, Kothapalli areas since six months,
reportedly without the knowledge of the district health authorities.
"They haven't approached us before conducting the clinical trials. How
can they administer trial medicines on human beings without our
permission?" DM&HO Vishnu Mohan fumed.
  As per norms, a researcher who wants to
conduct clinical trials on humans has to obtain permission from the
Drugs Controller General of India (DCGI) and also register with
Clinical Trials Registry-India (CTRI) at National Institute of Medical
Statistics, which is controlled by the Indian Council of Medical
Research.
  The agency, which proposes the clinical trials, has to follow
certain international ethical guidelines and one among them is the
'informed consent.' "But these companies keep them in the dark about
the possible side-effects," Charla PHC doctor Anjaneyulu said.
As per the written agreement between the firm and the individual, the
person would be compensated if he/she (who is ready for the trial)
falls sick during the experiment.
"A majority of the respondents are illiterate people who cannot
understand the consequences of the trials as 'explained' in the
consent form," reasoned CPM district leader Narsa Reddy. Very recently
one Podila Kumaraswamy of Vijay Colony in Charla mandal fell ill after
he developed vomitings and complained of palpitation.
"Several blood samples were collected from Kumaraswamy within 24 hours
as the researchers tried to figure out at what time the drug reached
blood. It is inhuman as the person must have had a traumatic time,"
said the DM&HO.
District collector N Nageswara Rao has ordered an inquiry into the episode.


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