Tuesday, October 26, 2010

Why did Carcenogenic expert change his mind to attend Adcom in last minute?

This is an article from BIOWORLD

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=56203

FDA spokeswoman Ayse Yeaton told BioWorld Today that the agency sent nine hard copy letters and 89 e-mails to members of the public last week in response to inquiries and accusations about the lorcaserin panel.

Some of the FDA's outside advisers admitted during the September meeting that they were perplexed by the carcinogenicity data and lacked the expertise to weigh the decision before them.

Indeed, the 15-member panel consisted mostly of diabetes experts, with a few cardiologists and statisticians thrown in, along with a patient representative and a nonvoting pharmaceutical industry consultant.

FDA spokeswoman Karen Riley told BioWorld Today in September that "We did have an expert on rodent carcinogenicity slated to attend the meeting, but he changed his mind late in the process." Nonetheless, the FDA argued that a team of "FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies."



[Verso] Read the last paragraph, they had an expert slated and he changed his mind in the last minute, why? doesn't that smell?

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