Veteran FDA observer Blunter is back with more accusations about the FDA’s unwillingness to let the public know what it knows.
When I last blogged about the utter incompetence and disarray in the FDA establishment, I emphasized the "transparency" and "culture" there. If any further proof is needed, look at the Public Citizen FOIA complaint for information on parecoxib. (Copy of the complaint is with the FDAWebView article, 1/25) (Ed’s Note: It isn’t available elsewhere on the web but I have seen a copy of it). Here we have the HHS Secretary Nominee saying the White House is looking at new candidates for the FDA Commissioner post, with the issue of Vioxx and similar drugs raising the question of "what did you know and when did you know it," amid the spectacle of supposed protectors of our health groping for their hindsides and unable to find it with both hands.
You will recall, I stated in my previous post:
For sure, more funding which would be effectively applied will be needed but unlikely to do much good so long as the current management and culture is allowed to continue.
Presently, outsiders who want or need information on FDA decisions, and the like, are channeled through a Freedom of Information process which takes two years or more just to get around to the request, and then some more time and redactions to get the info out, if indeed any is released. It has been long-standing, recognized management incompetence, worse in the Center for Drug Regulation than anywhere else (probably in the whole government). There is no transparency in what FDA is acting on, or ability for any one to compare in real time other similar data, by scientists or others, who may have data of their own or seek to learn from the existing records FDA has passed upon. And when it comes to other than medical and scientific data, the likelihood of getting anything at all to look at several years down the road is even more remote.
And there has been no effort in the last near decade to do anything about it, like introduce management or data submission processes to make the system workable. Human clinical data and drug experience (appropriately clad to protect patient privacy) is a public resource, not a trade secret, for example. But youd never know it at FDA.
Last October, the Health Research Group of Public Citizen sought out relevant materials which FDA used to deny approvability of a COX-2 like drug, parecoxib (sold under the brand name Dynastat in Europe). A safe assumption is that Sidney Wolfe wasn’t seeking to compete with Pfizer and was seeking to initiate a public risk/benefit debate.
Not only did FDA fail to grant access to the data in its possession, redacted or not, but has not yet responded to the request at all. This is the old "stonewall" response–not "yes", not "no"–typical of FDA. May be the data that lead to the turndown of parecoxib would have substantiated the position of Whistleblower Graham on Vioxx, et al.
The vision is of the FDA topside huddled together, planning their next move for their own agenda—the world and naysayers be damned.
Need we have further proof of the bankruptcy the policies and abilities of those presently holding FDA positions of control. Lets wish Sid Wolfe swift success in the courtroom.