Thursday, June 25, 2009

Salmon's Excellent Insights on Yesterday's FDA Transparency Webcast

I knew Salmon would wander by, to grace us with some cogent commentary and analysis -- on the above topic -- and in the comment box, here, he just did:

. . . .Most of the comments as they came from outside the agency were fairly consistent and limited. I didn't pay attention to the non-drug portions so I'll stay focused on comments related to drugs especially as this blog focuses on SP.

Many comments related to difficulties with FOIA, the methods used to redact documents (white out and then scan into pdf image files so they can't be searched). Not including reviews consistently in Drugs@fda. Also not releasing reviews of supplemental indications that have not been approved due to lack of efficacy or safety because companies still promote these uses off-label. One ex-FDA reviewer pointed out the FDAAA 2007 requires release of the action package but not IND reviews which may be pertinent but even so with the very first one under this law there was inappropriate redaction of drug metabolism information and >90% or market withdrawals are due to drug metabolite toxicities. One mother of a boy who died didn't understand why numbers of patients taking a drug should be redacted as it's needed to assess adverse event rates.

Industry comments were pretty much as expected. Don't release stuff because they're trade secret or commercial secret. There were several comments debating the extent of redaction.

However several people indicated that this could be overcome by simply not releasing information until either approval, nonapproval, or prior to an advisory committee and not during the review process.

There were also a number of people who said FDA needs to release all the raw data because analysis by FDA reviewers or analysis of avandia data that came out under discovery showed very different safety risks than admitted to by companies or the FDA.

One ex-FDA reviewer recommended that all new molecular entities have advisory committee meetings in spite of their problems. Dr. Sharfstein probed this and it was suggested that when FDA reviewers can't speak and all the questions are answered by industry or FDA senior people, a different picture may emerge. However when reviewers who know the data are allowed to speak, the committee members can get more nuanced and detailed answers which they can probe and in that reviewer's experience this in one case he was involved in changed the likely Advisory Committee "yes" vote to a "no" vote by the Committee.

Another unique comment by this ex-reviewer was the need to change the FDAAA of 2007 and the Good Review Management Practices/Good Review Practices (GRMPs or GRPs), because they were allowing insider trading.

Off line this ex-reviewer was passing out statements because he had originally been scheduled to speak and when FDA saw his comments he was removed (based on the claim that they were off topic). I have the package which includes the scope of the topics to be discussed and the rules for the meeting and they certainly seem within topic to me, embarassing to FDA yes, but still within the scope.

One of the draft statements is particulary interesting for this blog as it refers to possible insider trading and knowledge of internal FDA information regarding asenapine and possibly the sale of Schering-Plough to Merck. . . .

-- Salmon

Excellent, Salmon! To your last point, I can arrange to collect anything that was made public at an open, federal governmental agency meeting. Whether I'll run it, here, may be another matter. I do try to confine my material to public documents, officially released. Let me get back to you on this, in the comments.

Thank you so very much!


1 comment:

Anonymous said...

I'm not sure how useful it will be to your blog. It's a very general statement and doesn't even have as much detail as the timelines I've put forward here in the past based on public information and speculation. (I can't find the specific post and link right now.)

It does make me wonder though if this has anything to do with the warning Frank Torti (the acting FDA Commish until Hamburg took over) gave to FDA staff right before he left about not to releasing internal e-mails and taking back the FDA.

As to the rest of the package I think it's pretty explosive stuff. It was distributed with the e-mail removing the ex-reviewer from a panel and a strongly worded complaint to Sen Grassley and Rep Stupak and others. The prohibited comments are so explosive that I really hope that someone big runs with it and digs deeper.