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Ethical issues involved in drugs

 

While the IOM did not target the Avandia trial in particular, FDA Commissioner Margaret Hamburg asked the independent, nonprofit medical group to weigh in with at least an initial finding on general ethical issues involving the safety of studying the risks of drugs already in use.

The FDA called in 2007 for the TIDE study, which aims to enroll 16,000 patients and end in 2015, although some critics say it could take longer.

Analyses of other data since then have convinced some researchers that Avandias risks are greater than those of Actos and have repeatedly called for the trial to be halted.

Glaxo has defended its drug, saying data overall shows it does not increase the risk of heart attack, stroke or death.

Ref and Read more: http://www.researchhealthcare.com/fda/glaxo-is-conducting-a-randomized.html

 

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