Replies to post #51487 on Biotech Values

[Nerf]

Well, Dew, your levelheaded responses often get the best of me. even if it's in "Nerf's face". But I have to say that I have mixed feelings about this. On the one hand the FDA isn't sitting here trying to orchestrate the takeover of the Pharm industry by one group of people, they're not this shadow organization with an interest/agenda...

Then again, if you try claiming total objectivism by the FDA, that it's only one seriously rigorous set of stringent rules. Well, then, can you seriously state that?

There are both rules, and personalities, of people involved. Seriously smart people, at that. There are histories, old employers, old coworkers and most of all power and money, involved. These dudes won't sit on that board forever, will they?

They leave and get VERY lucrative contracts for everything imaginable.

Does this set the stage for politics and subjectivism?

OK!

[walldiver]

I'm saying that Pazdur is obsessed with methodology at the expense of clinical efficacy and benefit. He held up the Avastin sBLA to make a methodological point. He could have made his point while deciding to hold up approval of a different, less effective treatment (he often does). Adding Avastin for frontline metastatic breast cancer is not one of the lesser efficaceous treatments. A hazard ratio of 0.50 in the primary endpoint (Avastin doubled median time to progression), a similar HR in the secondary endpoint of PFS (again, almost a double at the median), and an HR of 0.67 in interim overall survival aren't marginal results. He's playing with people's lives here, and he doesn't give a flying fu...squirrel.

If I were an armchair psychologist, I would say that he took the MD Anderson beat-down far too personally, and that a lot of his stubbornness on this issue is due to his ego compensating for having to accept the less prestigious position at the FDA. However, I'm not an armchair psychologist, so I would never say that ;-)

[rsox]

Bureaucratic management, as distinguished from profit management, is the method applied in the conduct of administrative affairs the result of which has no cash value on the market.
http://www.lewrockwell.com/lora/m.lora38.html
~ Ludwig von Mises

When it comes to our health, one would assume that the government is there to protect us through reasonable and sensible regulations. This is, however, far from the truth. The FDA in particular has been the cause of misery for those who have been unable to legally seek cures and treatment, the result of which ranges anywhere from health complications to death.