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If you ever thought that taking part in drug trials seemed an easy route to modest riches, the preliminary experiments on human beings involving compound TGN1412 should have disabused you of that notion. This was the drug, made by TeGenero and trialed by the drug-testing firm Paraxel, that left six healthy men seriously ill, two of them close to death.
Although it was a public relations disaster for both companies, public
enthusiasm for trials has long been dwindling, and not just among the
healthy, who are first in the experimental firing line (before being used to
make sick people better, scientists must ensure that potential therapies do
not make healthy people sick). Even the ill are reluctant to entrust what
little health they have to pharmaceutical companies. One study found that 71
per cent of cancer patients deemed eligible for clinical trials decline the
opportunity.
That contrasts with a growing preference by the drug firms for larger trials,
which tend to show up rare side-effects earlier. Bigger trials are seen as a
way of preventing another Vioxx — an arthritis drug that was found, after
licensing, to cause heart attacks and stroke. Forbes.com reports that
compensating affected patients could cost the makers, Merck, $38 billion
(£24.4 billion).
And so Big Pharma has begun outsourcing its trials to India, a move that,
according to bioethicists, could create a “new imperialism”. India has huge
numbers of sick people glad to test drugs in return for minimal, if any,
recompense. The patients rarely mind — to them, experimental healthcare is
better than none at all — and they rarely complain. India also has a
homegrown supply of highly educated, English-speaking doctors, who cost a
fraction of their Western counterparts.
AstraZeneca has opened a drug-testing facility in Bangalore; Pfizer has done
the same in Bombay. At the moment one in a hundred global clinical trials is
conducted in India, but Oxygen Healthcare, a British consultancy, estimates
that in five years’ time that figure will have risen to one in ten.
This makes financial sense but others are clearly worried that poor,
illiterate patients are being exploited. There is certainly doubt over
whether they are giving informed consent. The Indian Journal of Medical
Ethics reports that patients are often unable to distinguish between
trials that might benefit them and those that won’t. Another study pointed
out that, of the country’s 14,000 general hospitals, fewer than 200 are
equipped to carry out drug trials adequately.
Indian patients are often used to test medicines that, once marketed, they
will not be able to afford.
The editors of the American Journal of Bioethics say in their blog that
“pharma trials in India should be the focus of a huge amount of attention in
the world of research ethics”. Even more forthright was a recent opinion
piece in The Scientist. “If Gandhi were alive today, he would lead
protesters to the doors of a clinical research trials facility, where the
oppression of the Indian poor dwarfs that of the 1930s.” This is a reference
to Gandhi’s march against the British salt tax, which made it illegal to
obtain salt from anyone other than the British Government, even though it
could be collected along the coast. Gandhi and his supporters marched 240
miles from western India to coastal Gujarat, gathering the mineral on the
way. The march ended in a bloody confrontation at a salt factory.
The Indian Government now stands accused of colluding in this new oppression.
In 2004 it stipulated that drugs tested in India should first be proved safe
in their country of origin; in 2005 the law was revoked.
This issue deserves close inspection but we should beware a knee-jerk cry of
“exploitation”. The most rational thing to do is to look at the equation of
exploitation: does the drug company benefit unfairly from its interaction
with the patient? If so, then perhaps The Scientist is justified in
asking: “How long before the people of the nation of Gandhi rise up to
reject a new imperialism?”
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