Testing Drugs on India's Poor

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http://www.truthout.org/issues_05/123005HA.shtml

 

Testing Drugs on India's Poor

By Scott Carney

Wired News

 

Tuesday 20 December 2005

 

India has been the focus of medical research since the time when

sunburned men with pith helmets and degrees from prestigious European

medical schools came to catalog tropical illnesses.

 

The days of the Raj are long gone, but multinational corporations

are riding high on the trend toward globalization by taking advantage

of India's educated work force and deep poverty to turn South Asia

into the world's largest clinical-testing petri dish.

 

The sudden influx of drug companies to India resembles the gold

rush frontier, according to Sean Philpott, managing editor of The

American Journal of Bioethics.

 

" Not only are research costs low, but there is a skilled work

force to conduct the trials, " he said. In the rush to reap profits,

Philpott cautions that drug companies may not be sensitive to how

poverty can undermine the spirit of informed consent. " Individuals who

participate in Indian clinical trials usually won't be educated.

Offering $100 may be undue enticement; they may not even realize that

they are being coerced, " he said.

 

For decades, pharmaceutical research in India didn't rely on

clinical testing. Scientists mostly reverse-engineered drugs already

developed in other countries. But in March, everything changed when

India submitted to pressure from the World Trade Organization to stop

the practice and implement rules that prohibit local companies from

creating generic versions of patented drugs.

 

Now, pharmaceutical companies can rest assured they won't lose

profits to a domestic market, and India is suddenly a profitable

location for performing the expensive tests required for Food and Drug

Administration clearance of any drug. Though it is still too soon to

tell how much the legislative change has boosted drug development,

observers say the number of studies conducted by multinational drug

companies has sharply increased since March.

 

Given the rising cost of drug research in the United States and

Europe, more and more drug companies are conducting clinical trials in

developing countries where government oversight is more lax and

research can be done for a fraction of the cost. According to a 2004

study by Rabo India Finance, a subsidiary of the Netherlands-based

Rabo Bank, clinical trials account for more than 40 percent of

drug-development costs. The study also found that performing the

studies in India can bring the price down by about 60 percent.

 

By 2010, total spending on outsourcing clinical trials to India

could top $2 billion, according to Ashish Singh, vice president of

Bain & Co., a consulting firm that reports on the health-care industry.

 

Regardless of where clinical trials are performed, the FDA

requires the same evidence showing that a drug is safe and effective

before it will approve any drug, according to a written comment from

Ken Johnson, senior vice president of The Pharmaceutical Research and

Manufacturers of America Foundation.

 

And it's the responsibility of the institutional review boards at

the medical institutions where the studies take place to " actively

pursue issues of informed consent, " according to another written

comment from Jeff Trewhitt, a spokesman for the pharmaceutical

industry trade group.

 

Nevertheless, even before the anti-generic rules were enacted,

companies performing clinical trials in India saw their share of

problems. In 2004, two India-based pharmaceutical companies, Shantha

Biotech in Hyderabad and Biocon in Bangalore, came under scrutiny for

conducting illegal clinical trials that led to eight deaths.

 

Shantha Biotech failed to obtain proper consent from patients

while testing a drug meant to treat heart attacks. Biocon tested a

genetically modified form of insulin without the proper approval from

the Drug Controller General of India or the Genetic Engineering

Approval Committee.

 

In another incident, Sun Pharmaceuticals convinced doctors to

prescribe Letrozole, a breast cancer drug, to more than 400 women as a

fertility treatment in a covert clinical trial - and used the results

to promote the drug for the unapproved use.

 

Shantha Biotech, Biocon and Sun Pharmaceuticals did not return

e-mails seeking comments for this story.

 

Pfizer and Eli Lilly have been conducting clinical trials in India

for many years, and Novo Nordisk and GlaxoSmithKline have also set up

trials in the last two years. The companies did not respond to

requests for comment.

 

Companies are attracted to India not only because of the huge

patient pool and skilled workers, but also because many potential

study volunteers are " treatment naïve, " meaning they have not been

exposed to the wide array of biomedical drugs that most Western

patients have, said Stefan Ecks, a lecturer in social anthropology at

the School of Social and Political Studies in Edinburgh who recently

published a paper on the marketing of antidepressants in India.

 

" Doctors are easier to recruit for trials because they don't have

to go through the same ethics procedures as their Western colleagues, "

Ecks said. " And patients ask fewer questions about what is going on. "

 

After the outcry against Shantha and Biocon, the Indian government

adopted stricter ethical guidelines for clinical research, but it's

too early to know whether companies are abiding by the new rules.

 

Also, critics say study volunteers may be taking risks without the

potential for reward. Since many pharmaceutical companies are

developing the drugs for markets in industrialized nations, it is

unlikely that India's poor will have access to most of the new medicine.

 

" Third World lives are worth much less than the European lives.

That is what colonialism was all about, " said Srirupa Prasad, a

visiting assistant professor of medical history and bioethics at the

University of Wisconsin-Madison.

 

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