[johncarpinelli]

We need the FDA to regulate drugs and medical devices. There's too much potential for quackery. I don't think removing the FDA is going to find a cure for diabetes. It's a fundamental research problem at this stage. Stem cells are showing some potential as a future cure. See the article below.

http://www.medicalnewstoday.com/articles/252759.php

We need more funding for medical research. PhDs should not be low-paid labor. Too many smart people drop out of research careers due to the low salaries. We should be paying medical researchers similar incomes to engineers at Silicon Valley tech firms.

California taxes are funding one of the biggest research efforts into stem cells. So the big tech firms are contributing to the effort through their taxes.

http://www.cirm.ca.gov/

[ramanujan]

Let's go point by point.

1) Regarding diabetes and the FDA:

  I don't think removing the FDA is going to find a cure for 
  diabetes.

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...

  Early in 1921, Banting took his idea to Professor John 
  Macleod at the University of Toronto, who was a leading 
  figure in the study of diabetes in Canada. Macleod didn't 
  think much of Banting's theories. Despite this, Banting 
  managed to convince him that his idea was worth trying.

  In January 1922 in Toronto, Canada, a 14-year-old boy, 
  Leonard Thompson, was chosen as the first person with 
  diabetes to receive insulin. The test was a success. 
  Leonard, who before the insulin shots was near death, 
  rapidly regained his strength and appetite. The team now 
  expanded their testing to other volunteer diabetics, who 
  reacted just as positively as Leonard to the insulin 
  extract.

  The news of the successful treatment of diabetes with 
  insulin rapidly spread outside of Toronto, and in 1923 the 
  Nobel Committee decided to award Banting and Macleod the 
  Nobel Prize in Physiology or Medicine.
  

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:

  We need the FDA to regulate drugs and medical devices.   
  There's too much potential for quackery. 

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...

  The extreme skepticism of my colleagues led me to believe   
  that I might never be funded to perform the crucial trial 
  of antibiotics...  I realized then that the medical 
  understanding of ulcer disease was akin to a religion. No 
  amount of logical reasoning could budge what people knew in 
  their hearts to be true. Ulcers were caused by stress, bad 
  diet, smoking, alcohol and susceptible genes. A bacterial 
  cause was preposterous.

3) Regarding researcher income:

  We should be paying medical researchers similar incomes to 
  engineers at Silicon Valley tech firms.

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:

  California taxes are funding one of the biggest research 
  efforts into 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...

  Last September, Nature predicted a stem cell showdown in 
  Texas, between the FDA and a company providing unproven 
  stem cell treatments, and that seems to be happening. In a 
  severe “warning letter” posted on the agency’s website this 
  week (but dated September 24, 2012), the FDA told 
  Sugarland, Texas-based Celltex Therapeutics Corporation 
  that its stem cell products fall under FDA regulation and 
  need to be approved before use in patients.

  The letter is a challenge to new regulations that the Texas 
  Medical Board put in place in April, which had made FDA 
  approval an option, not a requirement. Those regulations 
  state that doctors injecting stem cells into patients need 
  FDA approval or the approval of a local institutional 
  review board (IRB). The warning letter makes clear that the 
  FDA expects its approval to be mandatory—effectively 
  replacing the “or” with an “and”.

http://gizmodo.com/5881492/according-to-the-fda-your-stem-ce...

  In recent court filings, the Food and Drug Administration 
  has asserted that stem cells—you know, the ones our bodies 
  produce naturally—are in fact drugs and subject to its 
  regulatory oversight. So does that make me a controlled 
  substance? The bizarre controversy revolves around the 
  FDA's attempt to regulate the Centeno-Schultz Clinic in 
  Colorado that performs a nonsurgical stem-cell therapy 
  called Regenexx-C.

5) At the end of the day

  We need the FDA

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.

[jthol]

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.

[failrate]

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.

[freddealmeida]

I think you would be rather surprised what those standard really are. Far lower than you would expect.

[jthol]

I am aware of those standards. I'm also aware of how much worse it was before we had them.

[illuminate]

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.