[ataggart]

Counterfactuals are hard, but I wonder if anyone has studied whether or not the FDA is actually a net saver of lives. It seems to me that every time the FDA approves a new drug that will save X lives a year, it has necessarily cost X lives every year that the drug was delayed in the mandatory approval pipeline.

If FDA approval was optional (perhaps requiring a big "NOT FDA APPROVED" label), would the number of people who die from taking unapproved drugs (and who otherwise would have lived) be more than the number who die from being denied a drug (and who otherwise would have lived)?

As I write this, it reminds me a bit of the IP issue, and whether the patent system really is a net benefit or not.

[ramanujan]

You might be interested in these studies. The second link is to a discussion of Andy Grove's editorial in Science calling for the FDA to only certify safety (rather than safety + efficacy + comparative effectiveness). But it's the third that gets at your question:

http://www.cato.org/pubs/regulation/regv27n2/v27n2-8.pdf

http://marginalrevolution.com/marginalrevolution/2011/10/and...

http://fdareview.org/harm.shtml

  The delay and large reduction in the total number of new 
  drugs has had terrible consequences. It is difficult to 
  estimate how many lives the post-1962 FDA controls have 
  cost, but the number is likely to be substantial; 
  Gieringer (1985) estimates the loss of life from delay 
  alone to be in the hundreds of thousands (not to mention 
  millions of patients who endured unnecessary morbidity). ... 

  If the U.S. system resulted in appreciably safer drugs, we 
  would expect to see far fewer postmarket safety 
  withdrawals in the United States than in other countries. 
  Bakke et al. (1995) compared safety withdrawals in the 
  United States with those in Great Britain and Spain, each 
  of which approved more drugs than the United States during 
  the same time period. Yet, approximately 3 percent of all 
  drug approvals were withdrawn for safety reasons in the 
  United States, approximately 3 percent in Spain, and 
  approximately 4 percent in Great Britain. There is no 
  evidence that the U.S. drug lag brings greater safety.

Ultimately this boils down to a classification problem. There will be type I and type II errors associated with any kind of centralized approval process. And when studied in its totality, there is quite a bit of evidence that the type II errors are predominating: good drugs being slowed or denied.

The only way to prove this definitively is a side-by-side experiment with a new jurisdiction in which patients and entrepreneurs alike are free to choose and the FDA has no power.

[Gormo]

> Counterfactuals are hard, but I wonder if anyone has studied whether or not the FDA is actually a net saver of lives.

When did utilitarianism become an acceptable justification for usurping the right of individuals to make their own risk-reward tradeoffs?

[ataggart]

Arguing from principle likely won't get you very far with people arguing from assumed utility.

[Gormo]

I'm not arguing from principle as much as I'm pointing out that the utility value is itself subjective with respect to each individual; I'm criticizing the socio-political doctrine of utilitarianism which pursues the "greatest good for the greatest number" in accordance with a single, generalized definition of "good" applied to all, irrespective of the divergent preferences of each.

Treating individuals' health as something to be optimized with respect to a putative macro-level abstraction of society as opposed to treating individuals' health as something to be optimized with respect to each individual's particular happiness is the problem here.

The post I replied to was also an implicit argument from principle, in treating the net-lives-saved measurement, with respect to the aggregate population, as the overriding decision criterion. It's just that this is a bad principle in that it gives "saving" the life of someone living in misery due to an uncurable but not terminal disease the same moral weight as curing someone of a terminal disease, and gives the potential death of someone consciously willing to risk death in an attempt to alleviate suffering the same moral weight as the potential death of someone denied access to a treatment they were willing to try and which might have saved their lives.

[gus_massa]

Even with careful studies, there have been some awful messes. One famous example is Thalidomide: http://en.wikipedia.org/wiki/Thalidomide (If you are not impressionable you can use Google images.)

Some drugs investigations are discontinued because they cause complications or deaths in the small test groups. Another important number is how many additional dead could have been if everyone could take unapproved treatments.

And most people would sign whatever the doctor tells them to sign, for example a "NOT FDA APPROVED"-waiver. People thrust whoever has a white coat and promises a cure. There has been problems with peopled enrolled in official experimental drug test, that didn't understand the details, but had signed just another "usual" form handled by the doctors.

[dmm]

Thalidomide was extremely effective in treating morning sickness, it was just dangerous to fetuses.

Why does the Thalidomide tragedy justify the FDA testing for _effectiveness_?

[gus_massa]

Sorry, I couldn't remember something more relevant, like a pill for the heart that reduces the blood pressure but after some years it produces more strokes. But if no one test the new proposed drugs for effectiveness and side effects, then there would be more death and complications.

[wissler]

It's impossible to compute the number of treatments that weren't even invented because the inventor saw the FDA barrier as too much trouble for him to manage.

The real question is the unpopular one: by what right does the FDA insert itself between doctor and patient, between drug manufacturer and doctor?

Ah, dogma. It's killing us.