First of all, I think Harris raises one set of important questions. Unfortunately, the analysis is "old school", the idea that FDA has two cultures nonsense that came out of the clueless and conflicted IOM panel (full of folks who failed to disclosed their connections to trial attorneys, Soros, Chubb,)... And ironically he proves his point: you want safety and efficacy to be reviewed at the same time, especially as you develop tools to make drugs more targeted in terms of risk and benefit..
In the wake of Avandia, companies had better wake up and realize that if they do not get ahead of the curve, stop being defensive about drugs, pretend problems don't exist, stop asking questions because they are afraid of the answers, other people will ask and answer those questions anyway. These questions are going to come fast and furious and will not die down after PDUFA is passed and certainly not in a Democrat administration. So companies had better step up their investment in targeting which drugs work best in which people -- to make medicines safer and to respond to a growing movement to impose comparative effectiveness on Medicare.
But people are also interested in life saving medicines. Would Harris - or has Harris -- ever written about the FDA reviewer leaving because a drug that could extend life or help someone suffering from disease -- where was he on Provenge -- as if he or she were a lonely crusader?
Has he ever looked at the scientific evidence surrounding SSRIs or Ketek ), the drug Ketek replaced (in terms of it's side effect profile) or the impact running to Congress and the media has on public fears about drugs or the drug approval process. In other words, is such reporting responsible? We go back to the fact that fewer kids are using SSRIs and that has been associated with an increase in suicides.
Given that most, if not all, safety signals cannot be confirmed, except through biomarkers and post market surveillance or huge randomized trials, what is the consequence of what is Harris effort to carry water for the IOM-trial attorney wing of the drug safety movement..."no signal too small to scuttle a drug approval or require a randomized clinical trial to establish drug safety" . Everyone knows what this will mean to drug development: fewer drugs that -- because companies are forced to do one size fits all post market studies and can't do adaptive trials for approval -- will have fewer targeted drugs on the market. That means more targets for headline seeking pols and tort seeking trial attorneys. It creates a permanent state of fear at the FDA.
To my way of thinking, people like Johann-Lianng, Ross and Graham aren't leaving fast enough...Let them have their 15 minutes of fame griping to Gardiner. And let them be replaced with biologically-based reviewers who don't think it's a sin to work with industry to improve the risk benefit profile of medicines.
The question is, can the NY Times ever run a story on the FDA that covers the safety story from this angle?