Regulatory Focus™ > News Articles > NBC Investigation 'Raises Questions About Lax Regulatory Oversight'

NBC Investigation 'Raises Questions About Lax Regulatory Oversight'

Posted 05 March 2012 | By Alexander Gaffney, RAC 

An investigation by Dateline NBC has found that clinical trial compensation in India is often driving economically disadvantaged patients to enroll in the trials regardless of the risks to their own safety.

According to the Indian government, more than 1,500 Indians have died as a result of clinical trial participation since 2008. This number is likely far lower than the actual number, as "official documentation of the deaths is frequently incomplete or non-existent," says Dateline.

"Unlike the Western countries where there is an audit of each death during [a] clinical trial, we don't have a system like that at all," said Dr. Chandra Gulhati, an editor at the medical journal Monthly Index of Medical Specialties.

In a country where the average wage can be just 50 cents a day, the chance to make up to $400 dollars for a single trial can be a powerful incentive.

Dateline's investigation "raises questions about lax regulatory oversight in these studies, the integrity of some of the companies contracted to run them and the reliability of the data they produce."

Their investigation put forth a study plan to two contract research organizations (CROs) in India using a thinly-veiled study plan for Vioxx-a drug once approved in the US, but now withdrawn for safety concerns.

The CROs positive response to the proposed study put forth by Dateline-a sensational read-raised concerns from the US Food and Drug Administration's (FDA) former Commissioner, Dr. David Kessler.

"No contract research organization should undertake any clinical trial without being sure that the risks are acceptable in light of the benefits," said Kessler.  "And in light of what was known, that conduct is just totally unacceptable." 

Read more:

NBC - 'People keep falling sick': How poor Indians are recruited for clinical drug trials

NBC - In India, oversight lacking in outsourced drug trials

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