INDIA: Prime Destination for Unethical Clinical Trials

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INDIA: Prime Destination for Unethical Clinical Trials

By Keya Acharya

BANGALORE, Dec 14 (IPS) - Lack of regulation, accountability, low

costs of operation and wide availability of target participants are

reasons why multinational drug companies, researchers and

institutions are increasingly basing their clinical trials in India.

An estimated 40 percent of all clinical trials now take place in

Asia, Eastern Europe, central and south America. " There is no

compulsory registration system for clinical trials in these countries

and many do not follow European directives in their operations " , says

Dr. Sijtsma of the Netherlands-based WEMOS, an advocacy health

organisation tracking clinical trials in developing countries.

Sijtsma, who was in India for a bioethics conference, held earlier

this month at the Bangalore-based National Institute of Mental Health

Sciences, said there is a growing concern in India's medical and

civil society on the lax regulation and ethicality over clinical

trials conducted in this country.

In 2006, WEMOS and the Centre for Research on Multinational

Corporations prepared an overview of 22 known examples of unethical

clinical trials, eight of which were operating in India.

The Indian examples of illegal and unethical trials involved Sun

Pharmaceuticals and Novartis's Letrozole for inducing ovulation when

approved only for breast cancer, Novo Nordisk's for diabetes

treatment, Solvay Pharmaceuticals' for treating diarrhoea,

and 's for treating acute malaria, Pfizer's for cardiac

events, Otsuka's for arterial disease, Indian companies Shantha

Biotechnics and Biocon for diabetes and the Hopkins'

University's trials for treating oral cancer.

Other countries with documented illegal trials include Russia, Nepal,

Uganda, Peru, China, Nigeria, Argentina and even places like London

and New York involving well-known institutes like the U.S. National

Institute of Health, Walter Army Institute of Research, Centres

for Disease Control and several international pharmaceutical firms.

Dr. Bernard Lo from the University of California at San Francisco,

also here for the conference, said even more disturbing questions

arise in the field of stem cell research in its newest method called

Induced Pluripotent stem cell (iPs cells).

In this system, embryonic stem cells are not used, but virtually any

cell is taken to the laboratory, inserted with a human gene and grown

into human cells.

" This makes for laboratory manipulation of basic science research, no

consent is needed by anyone and the cells can be bought commercially,

giving rise to all sorts of ethical questions that need to keep pace

with the rapid research in this field, " said Lo.

" I am extremely concerned about the conduct of stem cell research in

India, " said Dr. Pushp Bhargava, a highly respected former director

of India's Centre for Molecular Biology at Hyderabad city. " We have

no idea where these cells are coming from, whether they have been

characterised,'' Bhargava told IPS.

" There is no method of validation or checking, " he complained.

WEMOS's Dr. Leontien Laterveer says a lack of transparency and

secrecy shrouding all clinical trials, whether in India or other

countries, makes it very difficult to obtain information about their

operations.

" We are appealing to Indian organisations looking at this issue to

come forward and collaborate with us, " say both Laterveer and

Sjitsma.

More importantly, there are insufficient checks by the European Union

in spite of the Helsinki Declaration on a code of ethics for clinical

trials, making it easy for drugs to enter the European market, add

the two.

" European pharmaceuticals are also not bothered about legal and

regulatory aspects,'' said Laterveer. `'They leave it to the

countries themselves.'' The Helsinki Declaration is currently under

review.

" We need the input of Southern experts to help process the review of

the Helsinki Declaration, " said Sjitsma.

Media exposés of exploitation in cases such as the U.S. Hopkins'

Hospital's collaboration with the Regional Cancer Treatment Centre in

Kerala, in 2000, forced the Indian Council of Medical Research (ICMR)

to inquire into the trials.

The results however are still not public and no action has been taken

against its then director, while the s Hopkins University barred

the principal investigator from heading future research with human

subjects.

In recent years, India has made some regulatory attempts, amending

its drugs and cosmetics act to require compliance by trial conductors

with a set of good clinical practices (GCP) guidelines along with the

ethics committee that the ICMR formulated.

But there is still no mandatory compensatory payment, or strong

penalty against the defaulting company.

" We need to pin down direct responsibility for monitoring with the

ethics committee and measures taken to permanently revoke the licence

of the defaulting company,'' says Adarsh Gangadhar, a lawyer attached

to the National Academy for Legal Studies and Research in Hyderabad.

Dr. Prathap Tharyan, head of psychiatry at the respected Christian

Medical College (CMC), Vellore, and South Asia coordinator of

Cochrane, a network of specialists working to improve evidence-based

healthcare, averred that `'deception, fraud and structural problems

in randomised clinical trials'' are rampant in India.

Tharyan has now helped set up an online Clinical Trials Registry

through ICMR. Its implementation, however, remains dependent on wider

awareness of the issues involved in India.

`'Ethics awareness in India is evolving and the law intervening, but

I find a deficiency in working out solutions for implementation,''

said Madhav Menon, one of India's leading legal experts.

The National Institute of AIDS Research (NIAR) at Pune is committed

to setting up community advisory bodies (CABs) with participation

from field workers, patients and others concerned to disseminate

awareness and information on the rights of participants in clinical

trials.

However, the entire concept of CABs is still evolving, with

insufficient information on rights or ethical principles and no

mechanism for redressal of grievances, NIAR's Dr. Sanjay Mehendale

told IPS.

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