Page 16 - Pharma eZine 140828

Can clinical trials in developing

countries ever be completey ethical?

By Nicole Neghaiwi, RepRisk Senior Analyst.

A sign in the corridor of the All India Insitute of
Medical Sciences - one of a growing number of

Indian hospitals that uses their paients to gather
data on experimental drugs - says much about the

challenges of conducing drug trials in emerging
economies:

Don’t spit.

Don’t feed the monkeys.

Don’t pay bribes.1

As soaring costs and strict regulaions become
more and more prohibiive in the Western world,

a growing number of pharmaceuical companies
are taking their trials to places like China, India,

Eastern Europe and Lain America. But criics argue
that the legal and ethical frameworks required

to level the playing ield between companies
and their subjects in these countries are not yet

in place. As Stephanie Kelly argues in an opinion

piece for the Washington Post in 2013: “For
people struggling to put food on the table and a
MSF
roof over their heads, ‘voluntary’ paricipaion in
clinical trials is a slippery slope.”2 Which begs the

quesion, can clinical trials in developing countries Clearly, the ethical hurdles facing pharmaceuical The quesion of informed consent is paricularly
“ever be truly ethical?
companies implemening major clinical trials sensiive in the case of placebo-controlled trials,

in developing or emerging countries are great. where paients may be denied access to potenially
Gaining regulatory and ethical approval to conduct life-saving treatments.

clinical trials in the developing world is oten much
Gaining regulatory and
easier than in the West - a major reason why these Finally, criics have expressed concerns that paients

ethical approval to
countries are so atracive in the irst place. But who paricipate in trials may not be given access

regulators have expressed concerns over the to post-trial medicines. Oten, treatments are not
conduct clinical trials in
risk of fraud and poor quality data; concerns made available in countries where trials take place

that are compounded by percepions of rampant unil long ater they are approved in the West.
the developing world is
corrupion and unenforceable laws.
Even ater approval, companies are not obligated

to make the drugs available to paients ater the
oten much easier thPerhaps even more troubling are allegaions that
an in trial period. For low-income paients, this could

”trial subjects do not beneit from clinical research mean that coninuing to beneit from a successful
the West - a major reason
as much as their Western counterparts. Human treatment is simply not inancially feasible.

rights acivists have accused pharmaceuical
companies of cuing corners when it comes to But despite these very real problems, most why these countries are so

protecing poor or vulnerable trial subjects from
researchers conducing drug trials in the developing atracive in the irst place.

world are not looking to exploit low standards of the negaive side efects of their drugs. This is
care and weak regulatory supervision. Emerging especially dangerous in countries where low

markets oten ofer well-trained doctors and sound literacy rates and a high respect for authority
medical infrastructure at a fracion of the costs 1. http://www.tampabay.com/news/business/the-latest-industry-being-outsourced- mean that paients may not be fully aware of
to-india-clinical-drug-trials/934677
available in the West.
2. http://www.theatlantic.com/health/archive/2013/02/testing-drugs-on-the- the risks involved in taking part in such studies.
developing-world/273329/

16 INSIGHT