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
"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.