No one was arguing that point. The FDA does good things. The FDA does bad things. The question is whether the FDA is more helpful than harmful.
I for one am happy that the FDA inspects my food and medicine and holds them to a standard of safety. On the other hand they do make some medical devices and advances overly expensive to make and create a barrier to entry into the market.
Sure, I am also happy that there is some regulatory body at all, but without consistent testing criteria and regulatory standards, it simply cannot be as effective.
I worked with a programmer who had designed a watch that had an array of sensors in it with a wireless device to relay the info to your computer automatically. It would have been great for marathoners or people with heart conditions. He wouldn't even start the process of getting it approved, because he was too intimidated by the FDA. That doesn't necessarily mean he was right, but the chilling effect is clear.
Re:Why the Fuck?
by freddealmeida on Monday January 21, 2013 @02:02AM
(#5090328)
I think you would be rather surprised what those standard really are. Far lower than you would expect.
I am aware of those standards. I'm also aware of how much worse it was before we had them.
Re:Why the Fuck?
by illuminate on Monday January 21, 2013 @10:41AM
(#5091905)
Exactly, the solution is to fix those standards, not remove them. That's why I tend to not take Libertarian "certification bodies for safety, not 'regulation'" ideas seriously.
1) Regarding diabetes and the FDA:
Well, before the FDA as such even existed, Banting and Best came up with the idea for insulin supplementation in 1921. A patient was treated by 1922. They won the Nobel Prize by 1923. Today's FDA would have made their methods completely impossible and they would have been criminally prosecuted.http://www.nobelprize.org/educational/medicine/insulin/disco...
Point: the FDA need not exist to make progress against diabetes. That is, federal regulation is not a necessary condition.2) Regarding type I vs. type II errors:
So that is the key question: is the goal to allow rapid technological progress or is the goal to prevent quackery? You can of course eliminate all quackery by rejecting all new devices (high false negative rate), and many major innovations sound like quackery at the beginning. Here's another Nobel Laureate, Barry Marshall.http://www.nobelprize.org/nobel_prizes/medicine/laureates/20...
3) Regarding researcher income: The thing is that the entire higher education establishment is about to crash hard with the student loan bubble. I think an alternative paradigm is to reduce the equipment costs associated with starting a bio lab, via diybio.org, biocurious.org, openpcr.org, and the like. This goes in hand with broadly reducing capital costs (regulatory + equipment). In so doing it will become easier to do biotech startups with a Valley culture, and the salaries will follow.4) Concerning stem cells:
Nothing against CIRM, they're fantastic. But the FDA is forcing the resulting stem cell startups overseas.http://blogs.nature.com/news/2012/10/texas-stem-cell-provide...
http://gizmodo.com/5881492/according-to-the-fda-your-stem-ce... 5) At the end of the day You might want to look at the FDA Alumni Association (http://fdaaa.org) or the membership list of the Alliance for a Stronger FDA (http://strengthenfda.org/members/).Why is it in Roche's interest to lobby for a stronger FDA? Because FDA alumni are hired by large manufacturers to lobby the FDA and increase barriers to entry for startups. When you get into the details of how regulations are actually enforced, it is all about relationships/politics/press coverage and has very little to do with technical merit.
I could go on in this vein...among other things, you might be interested in the fraction of pre-1938 drugs and pre-1976 devices that are routinely prescribed from an ostensible age of quackery.
However, the fundamental idea is not really to convince people who want the FDA that it should continue to exist, but to get a critical mass of people who don't want the FDA to create a place where it does not have power. Then you and those who agree with you can reside in the US, where the FDA has sole authority. And we can opt-out of the FDA, as both patients and entrepreneurs.
This is going to require thinking outside the confines of the United States and US politics, but the payoff will be nothing short of a revolution in the pace of biomedical innovation.