Developing country cannot afford products being tested

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Reference no: EM132154890

International drug companies have targeted India as a friendly environment for clinical drug trials. After guidelines for conducting trials were eased in 2005, participation soared from nearly zero to 150,000 participants in 2012.192 The trials infused $300 million into India in 2010. Conducting the trials in India reportedly saves the drug companies nearly 40% of the total cost of developing the drug because “health-care professionals are cheaper and liability is not very high.”

Indian participants in drug trials have been called “guinea pigs.” Critics charge that the procedures used in obtaining their consent to enroll in the trials are inadequate and may be, in certain instances, unethical as well. Specifically, critics claim that the trials involve children, the mentally ill, and the illiterate, who use “thumb impressions” to sign consent forms. The forms (which can be as long as thirty pages) have allegedly been condensed to one page and include “difficult words.”

The drug trials are conducted by Indian subsidiaries of major pharmaceutical companies, including Pfizer, Merck, GlaxoSmithKline, and Novartis. The FDA is aware of some of the issues with the trials and has requested certain information from the hospitals involved. Because proper procedures were not followed in one Pfizer study, Pfizer canceled the trial and subsequently created educational information, utilizing Indian languages, to be distributed to staff and patients.

1. Is the conduct of these international drug companies ethical?

2. Should it matter whether consumers in a developing country cannot afford the products being tested?

Reference no: EM132154890

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