Ethics vs economics: the cost of outsourcing clinical trials to developing countries

Ethics vs economics: the cost of outsourcing clinical trials to developing countries

Pharmaceutical drugs are increasingly being manufactured in China and India to reduce their production cost. How long before clinical trials are likewise relocated?

"As the demand grows for newer and better drugs for an expanding range of conditions, so too does the need for clinical testing. Health as a commodity repositions ethics within an economic framework, and human experimentation is no exception. Profits, rather than people, become the prime consideration.

Just as many global companies have moved their manufacturing and call centres offshore, the cheapest way to conduct clinical trials is to outsource them to the developing world.

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ACRO is the representative body of the powerful and rapidly growing industry in subcontracted medical research, which allows the pharma industry to turn out cheaper drugs more quickly. Contract research organisations (CROs) are now regarded as a major feature of privatised science. In 2010 they generated US$21.69 billion in revenue, and are expected to generate US$32.73 billion in 2015.

One of the advantages of using CROs is their knowledge of local conditions and networks which facilitates access to clinics, researchers, doctors and the most “willing” cohort of participants. However, local knowledge also involves an understanding of conditions best suited to business rather than the well-being of the subjects.

It is in some ways illogical – though morally justifiable – to demand that businesses such as CROs and the pharma industry prioritise the welfare of human subjects. Answerable to their shareholders, the task of these businesses is to maximise profits.

Unfortunately regulatory bodies, designed to protect the vulnerable, often fall short of their remit. In 2004, the US clinical trials regulator, the Food and Drug Administration (FDA), abandoned its adherence to the principles of the Helsinki Declaration (the professional code for research ethics) in favour of the less stringent Good Clinical Practice guidelines."

Full article from Paddy Rawlinson, Associate Professor of Criminology at University of Western Sydney:

theconversation.com/ethics-...

Interesting topic for someone with that academic background!

Something to sit and think about...

Neil

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