3 ms·

>The FDA has probably caused more deaths in the past half century than all of the rest of the American state put together, wars and all, by slowing progress in

>The FDA has probably caused more deaths in the past half century than all of the rest of the American state put together, wars and all, by slowing progress in medicine, making all sorts of avenues for research and development unprofitable, and making medicine that does exist far more expensive. As long as we're throwing around bullshit: false hope and pseudoscience has caused more unnecessary death at the hands of tricksters and con men in the past two thousand years than all wars humans have fought or ever will fight. Having worked in biotech I was never a fan of some (or many) of the FDA's policies but I found this insulting. You have no clue how hard it is to develop any medicine that doesn't harm the first few patients you give it to, let alone one that actually reaches the market to help thousands or millions. You have no clue what it is like to be the only gatekeeper between a $900 billion industry working on some of the hardest scientific problems of our time and 300 million people. Almost all of whom want their cake, to eat it now, and for the calories to magically disappear from their gastrointestinal tract. The FDA is not a product of pharmaceutical companies, it is a product of a political system made of voters like you who decide their policies based on Libertarian pamphlets, Fox News, and Reddit. A political system that allows pharmaceutical companies to selectively withhold data, that has gutted the basic scientific research institutions that allows pharma to finance billion dollar ventures, and that mercilessly punishes any mistake that it itself is supposed to catch. You get what you vote for.

temphn 13y ago
The FDA is not elected, or even indirectly elected. They are career bureaucrats with career tenure who cannot be fired. How would you even know that they are doing a good job? Last I looked, Americans have terrible health care relative to other countries; the FDA has no responsibilit for that?
- HarryHirsch 13y ago
  Access to healthcare is firmly in the bailiwick of Congress. Hell, the rest of the First World has similar authorities that determine what drug gets to market, their criteria are similar, and their healthcare metrics aren't nearly as awful as the United States. And for the "career bureaucrats", if you want a modicum of stability you need them, you can't have elections or change the rules every other year - what you need is institutional memory and predictability.
- akiselev 13y ago
  You must be kidding, right? The for the last 20-30 years the head of the FDA has been a very volatile position covered with public scandals and the agency has an insane turn over rate due to the structure, workload, and public pressure [1]. Actually it looks like the developed countries with more, better treated bureaucrats are doing far better. [1] http://www.washingtonpost.com/r/2010-2019/WashingtonPost/2012/11/19/National-Politics/Graphics/PEW_FDA_Public_19112012.pdf http://www.washingtonpost.com/r/2010-2019/WashingtonPost/201...
exratione 13y ago
This was written by people who are much closer to your viewpoints on economic freedom than mine. They are very mild and conservative in their estimations of cost in lives. I suggest you read it: http://fdareview.org/harm.shtml 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). When we look back to the pre-1962 period, do we find anything like this tragedy? The historical record—decades of a relatively free market up to 1962—shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level. The Elixir Sulfanilamide tragedy, in which 107 people died, was the worst of those decades. Every life lost is important, but the grisly comparison is necessary. The number of victims of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.
- HarryHirsch 13y ago
  The pharmaceutical industry was doing extremely well until the 1990s - that's 35 years of success despite the FDA. Now what it is that caused the pharma crisis that started in 2003 I do not know. Is it the fact that the easy fruits have all been picked, there is nothing left to be discovered because everything at market already does a good job at a much better price point than any new drug? Or is it the fact that Pharma doesn't produce on a timescale that Wall Street likes, or both? Hell, Facebook is valued like Pfizer, but Facebook gives faster returns on capital. Your argument is completely at odds with observable facts.
  - webmaven 13y ago
    Consider that direct-to-consumer marketing of pharmaceuticals was allowed in the US in 1997. Is it so surprising that the new drug pipeline started drying up a few years later? Currently, marketing budgets dwarf R&D budgets at the large pharma companies, so I don't expect the situation to improve any time soon.
- 13y ago
yuhong 13y ago
To be honest, I doubt drugs make sense for all diseases. Autism may not have one single cure for example.

temphn 13y ago

The FDA is not elected, or even indirectly elected. They are career bureaucrats with career tenure who cannot be fired. How would you even know that they are doing a good job? Last I looked, Americans have terrible health care relative to other countries; the FDA has no responsibilit for that?

HarryHirsch 13y ago
Access to healthcare is firmly in the bailiwick of Congress. Hell, the rest of the First World has similar authorities that determine what drug gets to market, their criteria are similar, and their healthcare metrics aren't nearly as awful as the United States. And for the "career bureaucrats", if you want a modicum of stability you need them, you can't have elections or change the rules every other year - what you need is institutional memory and predictability.
akiselev 13y ago
You must be kidding, right? The for the last 20-30 years the head of the FDA has been a very volatile position covered with public scandals and the agency has an insane turn over rate due to the structure, workload, and public pressure [1]. Actually it looks like the developed countries with more, better treated bureaucrats are doing far better. [1] http://www.washingtonpost.com/r/2010-2019/WashingtonPost/2012/11/19/National-Politics/Graphics/PEW_FDA_Public_19112012.pdf http://www.washingtonpost.com/r/2010-2019/WashingtonPost/201...

exratione 13y ago

This was written by people who are much closer to your viewpoints on economic freedom than mine. They are very mild and conservative in their estimations of cost in lives. I suggest you read it: http://fdareview.org/harm.shtml 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). When we look back to the pre-1962 period, do we find anything like this tragedy? The historical record—decades of a relatively free market up to 1962—shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level. The Elixir Sulfanilamide tragedy, in which 107 people died, was the worst of those decades. Every life lost is important, but the grisly comparison is necessary. The number of victims of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.

HarryHirsch 13y ago
The pharmaceutical industry was doing extremely well until the 1990s - that's 35 years of success despite the FDA. Now what it is that caused the pharma crisis that started in 2003 I do not know. Is it the fact that the easy fruits have all been picked, there is nothing left to be discovered because everything at market already does a good job at a much better price point than any new drug? Or is it the fact that Pharma doesn't produce on a timescale that Wall Street likes, or both? Hell, Facebook is valued like Pfizer, but Facebook gives faster returns on capital. Your argument is completely at odds with observable facts.
- webmaven 13y ago
  Consider that direct-to-consumer marketing of pharmaceuticals was allowed in the US in 1997. Is it so surprising that the new drug pipeline started drying up a few years later? Currently, marketing budgets dwarf R&D budgets at the large pharma companies, so I don't expect the situation to improve any time soon.
13y ago

yuhong 13y ago

To be honest, I doubt drugs make sense for all diseases. Autism may not have one single cure for example.