[afro-nets] India against foreign clinical trials?

[Jawad Asghar <jawad@alumni.washington.edu>]

Will India rise up against the oppression of foreign clinical
trials?
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Salt in the Wound

http://www.the-scientist.com/article/display/23296/

In March 1930, Mohandas Gandhi set out from his ashram in west-
ern India on a 387-km trek to the sea. Twenty-five days later
the tens of thousands who joined that march watched as he
stooped, raised a handful of salty mud, and declared the end of
British imperialism in India. The march culminated as Gandhi led
nonviolent protesters to the doors of the salt factory in
Dharasana, where they attempted to push their way into the fa-
cility without weapons or raised fists. On that hot day hundreds
were beaten, a spectacle that would make its way into newspapers
worldwide and change the face of India forever.

If Gandhi were alive today, he would lead protesters to the
doors of a clinical research trials facility, where the oppres-
sion of the Indian poor dwarfs that of the 1930s. Why? Not be-
cause Gandhi was a Luddite, a man who held meetings while spin-
ning thread. And not because many of the excellent research in-
stitutions that have led India into its embrace of multinational
bioengineering and medical research bear his family name.

No, the problem for Gandhi would be the outsourced clinical tri-
als that have enrolled tens of thousands of Indians in a $1 bil-
lion business aimed not at the improvement of Indians' health or
technology, but at providing deep discounts to pharmaceutical
companies in other nations.

It is a perfect storm: The number of open slots in clinical tri-
als around the world increases, the number of Americans willing
to enroll in such trials lags (as few as 1.7% of patients with
cancer), and the cost of clinical trials in India is half that
in the United States. It is no surprise that American and Euro-
pean pharmaceutical companies are fanning out across the second
most populous nation in the world.

Physicians in India report that a largely illiterate subject
population, entirely unclear about risks and benefits, asks only
one question: Doctor, should I enroll? At least one study in the
Indian Journal of Medical Ethics reported that many Indian re-
search subjects are utterly unprepared to distinguish between
trials likely to provide benefit and those that will not (see
www.issuesinmedicalethics.org/141cv013.html). According to a
2005 report in New England Journal of Medicine, fewer than 200
of the 14,000 general hospitals in India are capable of conduct-
ing clinical trials adequately.

Why do Indians, most of whom are poor, flock to clinical trials?
One reason is that most of the nation is served by small and
ill-equipped hospitals. The "chambers of commerce" for clinical
trials in India point to the advantages of this fact: Indian pa-
tients are often untreated, reducing the number of confounding
factors in study of medications. And a tiny payment, by US stan-
dards, to an Indian enrollee in a clinical trial could amount to
three months' wages or more. Incentive payments to physicians
for enrolling research subjects are also amplified greatly by
the exchange rate.

The government attempted in 2004 to rein in unsafe international
clinical trials by insisting that drugs tested in India must
first be proven safe in their country of origin. But that law
was eliminated in 2005, followed closely by an avalanche of new
trials. Concerns about trials that are designed to demonstrate
nominally important data, are poorly designed, or are just plain
unsafe abound. Some trials are conducted on humans without prior
animal studies having been performed. In one unapproved clinical
trial for example, 435 women were given an anticancer drug to
treat fertility, but did not know the drug was not cleared for
this use.

The same imperialism that supported the salt factories of
Dharasana in 1930 today manifests itself in Mumbai, Sevagram,
and around India, where clinical trials too offensive for Ameri-
can research subjects are proffered to a billion residents of
the nation Gandhi fought so hard to emancipate. How long before
the people of the nation of Gandhi rise up to reject a new impe-
rialism?

Glenn McGee is the director of the Alden March Bioethics Insti-
tute at Albany Medical College, where he holds the John A.
Balint Endowed Chair in Medical Ethics.

mailto:gmcgee@the-scientist.com

-- 
Rana Jawad Asghar MD. MPH.
Coordinator South Asian Public Health Forum
mailto:jawad@alumni.washington.edu
http://www.DrJawad.com
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