On the ethics of clinical trials

Dr. Balasubramanian, in his Speaking of Science column in the Hindu, writes about the need to stick to Helsinki declaration and not follow FDA:

Take the case of the trial, in 2001, of a drug that acts against sudden lung collapse in children and thus saves lives. Initiated by the U.S. firm Discovery Labs, this wanted to try the drug on children in a Latin American country.

Rather than compare their drug with one of the several effective drugs already in use, the company wanted to give inactive placebos to 325 children in the control group.

The Food and Drug Administration (FDA) of the U.S., which clears such trials, warned them that this was unethical, since effective treatments were available in the U.S. and Europe (even if not in the Latin American country).

The company then had to change the protocol and gave the control group the alternative active treatment. This was in keeping with the Declaration of Helsinki.

Yet, with increasing pressures from companies and sponsors, FDA is starting to buckle.

It has announced that starting October 2008, it will shelve the Helsinki Declaration, and adopt a new standard called Good Clinical Practice (GCP).

This is a document prepared by drug regulators and drug companies from the US, European Union and Japan.

As the journal Nature notes in its 22 May 2008 issue: ‘Although GCP deals with subject protection, it is in essence a manual on how to conduct rigorous clinical trials, not a human rights document…. If FDA jettisons Helsinki, it risks sending a message that ethical considerations are expendable when research subjects live half a world away’.

Indian agencies such as the Drug Controller General of India, Indian Council of Medical Research (ICMR), and contract research organizations that conduct and oversee human trials, and also the institutional ethics committees should take note.

Overall, the Helsinki Declaration argues for ethical universalism. Let us not follow FDA and change our guidelines. After all, it cannot be that some humans are more equal than others.

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One Response to “On the ethics of clinical trials”

  1. kritika Says:

    You have very well stated that clinical research is now being taken up in India seriously. I must say that still there are not many institutions offering a course on such a sensitive topic. ICRI is one of the premier institutes of the country and aims at promoting clinical research in the country. With foreign recognition and good faculty, its future prospects seem to b very bright. A number of clinical research projects have been taken up by ICRI and hav produced medicines of great value. It should b seriously considered by all aspirants of research very seriously. To apply for the the college just click on the url..http://tinyurl.com/6ellwe

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