Hereâ€™s the first paragraph:
The FDA seems to be under fire from all sides these days, with everyone from drug industry pooh bahs to would-be watchdogs nipping at its heels. The agency, some charge, is going slow on approvals due to a risk-averse culture deepened through the experience of Vioxx and other product safety crises. Resignations are up, morale is down and the put-upon bureaucrats are laying low, the story goes. Others complain that reviewers are subject to political and corporate pressure through PDUFA and a nefarious web of relationships.
And hereâ€™s a link to the complete article:
Hereâ€™s what I had to say about the David Grahmatization of the whistleblower culture:
Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not â€œweep and whine and try to get decisions made that are based on politics rather than on science.â€ Whistleblowers, he acknowledges, at least deserve â€œgrudging respectâ€ for letting it be known who they are, â€œbut what is truly damaging are the silent leakersâ€ who try to force political pressure on FDA decisions. â€œThe motive may be either to get drugs approved or not approvedâ€”it cuts both ways.â€
As Jimmy Durante said, â€œIâ€™m surrounded by assassins.â€