Quote:
Originally Posted by Mahler9th
"...government transparency."
In my experience, transparency or lack thereof might be considered differently from the likely fact that even amongst experts, there can be disagreement.
I remember attending the FDA advisory panel hearing for a new type of medical equipment for which I had US commercialization responsibility when I was 27. Quite a while ago.
We had spent $$$ on the trials, worked with top doctors and teaching hospitals, et cetera. Lots of highly-paid consultants. Our company was a big European player.
The same day the panel heard the presentation from a Costa Mesa-based US start up that I think was already publicly traded-- slightly different technology. Second tier docs, poor data, some deaths, et cetera.
The panel advised FDA to grant their PMA but not ours. I remember the speculators running to the pay phones 'cause the market was still open.
|
Well, the FDA approved that Alzheimer drug so ...
Quote:
|
Our scientific, healthcare and regulatory system includes opportunities for disagreement, et cetera. I think that is good.
|
The scientific disagreements, absolutely. As you hinted somewhat if I read it correctly, the behind the scenes promotion lobbying activities and the money involved can skew the outcome. Even apart from that, when it comes to overall public healthcare, it's oftentimes a subjective decision. In the Bell's palsy case however, someone in the FDA got the math wrong as far as I can tell.