Saturday, October 16, 2010

Did Dr. David Orloff an Ex FDA division director; influence FDA in drafting review docs on Qnexa and Lorqess?

Is Dr. David Orloff an Ex FDA division director who oversaw the review of drugs to treat metabolic and endocrine disorders the reason why FDA did not chew VVUS(Qnexa).


This is a conspiracy theory but draw your own conclusions.

http://www.biospace.com/news_story.aspx?NewsEntityId=156217

http://seekingalpha.com/article/125309-four-weighty-reasons-to-invest-in-vivus

A potential diabetes indication has the potential to become a first-line therapy, taking advantage of an apparent shift in thinking at FDA in favor of treating diabetes by treating obesity. (VVUS’s obesity clinical trials are being led by Dr. David Orloff, former director of the FDA’s Division of Metabolic and Endocrine Drug Products


David Orloff, an FDA division director who oversees the review of drugs to treat metabolic and endocrine disorders, has announced plans to leave the agency and join Medpace, a contract research firm based in Cincinnati that runs clinical trials, the New York Timesreports. Orloff, who will be the third ranking agency official to leave since this summer, spent 11 years at FDA, including five years as a division director. Orloff was in charge of the agency's review of Bristol-Myers Squibb'sdiabetes drug Pargluva. An FDA advisory committee recommended Pargluva for approval in September. In October, FDA said the drug would be approved only with additional trial data. Two days later, the Journal of the American Medical Association"published a blistering critique" of the drug's cardiovascular risks, according to the Times. After additional discussions with FDA, BMS said it would be several years before the drug could be approved. Orloff said of the JAMA editorial, "We learned nothing new from the ... article. We were aware of all those issues." Orloff said his decision to leave the agency was not related to any concerns with the agency but rather an interest in a new opportunity. Orloff said he would continue to work at FDA for another month. Susan Wood, FDA's top women's health official, resigned in August, and FDA Administrator Lester Crawford resigned in September (Saul, New York Times, 12/7). 

http://www.washingtonpost.com/wp-dyn/content/article/2005/10/20/AR2005102001145.html

At the Sept. 9 hearing, David Orloff, the director of the FDA's Division of Metabolic and Endocrine Drugs, set the tone by saying the evidence that the drug may pose a risk was "based on very small numbers of events in individual studies and on small numbers overall."

3 comments:

  1. Thanks. Big pharma seems to be winning more consistently than the small guys... and it is clear that the preference is not attributed to greater scientific expertise, but to questionable relationships.

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  2. no way in the world this becomes a first line diabetes therapy. Xenical is more efficacious against metabolic syndrome serum markers, and Roche has never succeeded in getting this indication for Xenical. Why would a less efficacious drug succeed where Xenical has failed?

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  3. I'm not seeing the relevance. Spell out the conspiracy in more detail for me.

    ReplyDelete