FDA’s Public Participation Program: Forcing the Public to Review Discredited Studies

Months ago, CRE concluded that:

 1.  Out of all the studies cited by the FDA regarding the health effects of menthol that the only end points of any potential significance dealt with smoking initiation/ cessation.

2.  The initiation/cessation studies identified by FDA could not be used by the FDA because they failed to meet the standards of the Data Quality Act.

 3.  As a result of CRE’s numerous statements that the aforementioned studies  were not DQA compliant, that the FDA would award a grant to an outside Federal Contractor not to do a new study but to perform a review of the literature that would be policy based not science based—meaning to identify any component of any existing study, however trivial,  that could be used as propaganda by select numbers of TPSAC who had had already decided that the FDA should ban menthol.

4,   The contractor which would be chosen by the FDA  would be  RTI International.

5.   RTI International would direct Dr. Hersey to perform the “study”.

 It was for these  reasons  that CRE chose, out of the dozens of studies identified by the FDA, for its first review a study conducted by Dr. Hersey   and published its results on April 29, 2010 and May 7, 2010.

 CRE also requested the comments from Dr. Hersey on   May 17, 2010

 CRE had no response from either RTI International  or Dr. Hersey.

This inaction on the part of RTI  International  and Dr. Hersey resulted in CRE filing a Data Quality petition with the FDA, which included a finding that Dr. Hersey’s study was not Data Quality compliant.

 Yesterday, some six months later, on November 18, the FDA announced that RTI International/Dr Hersey was selected to manage  an analysis of a number of previous studies concerning smoking initiation/cessation to be conducted by a number of  institutions.

 Compliance with the President’s Open Government Initiative requires FDA not to outspend the public but instead provide the public with definitive answers when the public  responds to its requests for information.

 Consequently  in lieu of providing RTI International   with additional funds to develop talking points for select members of TPSAC,  FDA should provide RTI International with funds to respond to the detailed analyses  submitted by the public.  The studies should be released to the public by FDA,  not RTI,  to ensure that the said studies are compliant with the Data Quality Act.

CRE’s work to date has not been in vain  because we are pleased with the serious attention the FDA is giving to the aforementioned DQA petition filed by CRE and so noted in correspondence from the FDA to CRE.

Leave a Reply

Please Answer: *