5 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 m

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. Regulators at the FDA are capricious and malign, and there are countless stories of petty revenge via increased demands for data and enormous imposed costs in time and money. This is the way things always go in the late stages of centralized, powerful bureaucracy with a side order of regulatory capture. The only good thing I can find to say about the bureaucrats at the FDA is that they respond to regional regulatory arbitrage - to medical tourism - by loosening their grip and letting things through. Or at least they do when said treatments are so widely available elsewhere in the world that the risk of looking bad by continuing to block them in the US is worse than the risk of looking bad because one of the outcomes of a normal, low error rate in medicine gets picked up by the press. Look at simple stem cell transplants, now available in the US these last couple of years, for a good example of this in practice.

djur 12y ago
I appreciate people not being crippled or killed by poisonous patent medicines, myself. Or by untested procedures, or harmful implants and cosmetic surgeries, etc. It would be better if the FDA had more power over largely fraudulent markets like homeopathy, naturopathy, herbal medicine, etc. But for the time being those scams are largely unrestricted.
- yuhong 12y ago
  But do it carefully. Has probiotics ever harmed anyone for example?
  - akiselev 12y ago
    It's not regulated so we haven't studied it enough but yes, it's called probiotic sepsis [1]. [1] http://ajcn.nutrition.org/content/83/6/1256.long http://ajcn.nutrition.org/content/83/6/1256.long
akiselev 12y ago
>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 12y 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 12y 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.
specialist 12y ago
I'm intensely grateful for the FDA. I'm alive because of experimental treatments (bone marrow transplant), monitored by the FDA and others. At the time, patients with my profile had 90% mortality. I will tell you firsthand, and watching my hospital friends die, that in most cases, the cure is at least as bad as the disease. Which is why doctors, who would know best, often choose to go out with grace (no heroic measures). And yet science marches on. Today BMTs are routine and in some cases are practically outpatient treatments. The development and approval of new drugs and therapies are exactly as fast as they should be. Want something faster, then work towards it. In other words: less talk, more walk.
vwinsyee 12y ago
The FDA has more than likely directly prevented hundreds of millions deaths worldwide. It's literally one of very few safeguards you can rely on to know that you're not eating poison. Amusingly, the top comment on a front page HN post [1] right now concerns one of the first court cases [2] that gave FDA some real power. Before this case, companies could sell a poison like emetic tartar and market it as a hangover drug. Selling stuff like this still happens today in countries without an FDA equivalent. [3] It even happens in countries with a drug regulatory body, but one that's weak. [4] As with all regulation, there's a balance between benefit/risk. As you point out, there is a financial and time burden of regulation. But with warts and all, the work that the FDA has done and currently does far outweighs these burdens. > The only good thing I can find to say about the bureaucrats at the FDA is that they respond to regional regulatory arbitrage - to medical tourism - by loosening their grip and letting things through. Or at least they do when said treatments are so widely available elsewhere in the world that the risk of looking bad by continuing to block them in the US is worse than the risk of looking bad because one of the outcomes of a normal, low error rate in medicine gets picked up by the press. Look at simple stem cell transplants, now available in the US these last couple of years, for a good example of this in practice. I'm not quite sure how to respond to this rant. But I'll point out findings from a 2012 NEJM study comparing the FDA to the EU's EMA and Canada's Health Canada: [5] "RESULTS: There were 510 applications for novel therapeutic agents approved from 2001 through 2010 — 225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States." [1] https://news.ycombinator.com/item?id=7758508 https://news.ycombinator.com/item?id=7758508 [2] https://en.wikipedia.org/wiki/United_States_v._11_1/4_Dozen_Packages_of_Articles_Labeled_in_Part_Mrs._Moffat%E2%80%99s_Shoo-Fly_Powders_for_Drunkenness https://en.wikipedia.org/wiki/United_States_v._11_1/4_Dozen_... [3] http://ijp-online.com/article.asp?issn=0253-7613;year=2007;volume=39;issue=4;spage=206;epage=207;aulast=Khan http://ijp-online.com/article.asp?issn=0253-7613;year=2007;v... [4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1151014/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1151014/ [5] http://www.nejm.org/doi/full/10.1056/NEJMsa1200223 http://www.nejm.org/doi/full/10.1056/NEJMsa1200223

djur 12y ago

I appreciate people not being crippled or killed by poisonous patent medicines, myself. Or by untested procedures, or harmful implants and cosmetic surgeries, etc. It would be better if the FDA had more power over largely fraudulent markets like homeopathy, naturopathy, herbal medicine, etc. But for the time being those scams are largely unrestricted.

yuhong 12y ago
But do it carefully. Has probiotics ever harmed anyone for example?
- akiselev 12y ago
  It's not regulated so we haven't studied it enough but yes, it's called probiotic sepsis [1]. [1] http://ajcn.nutrition.org/content/83/6/1256.long http://ajcn.nutrition.org/content/83/6/1256.long

akiselev 12y ago

>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 12y 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 12y 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.

specialist 12y ago

I'm intensely grateful for the FDA. I'm alive because of experimental treatments (bone marrow transplant), monitored by the FDA and others. At the time, patients with my profile had 90% mortality. I will tell you firsthand, and watching my hospital friends die, that in most cases, the cure is at least as bad as the disease. Which is why doctors, who would know best, often choose to go out with grace (no heroic measures). And yet science marches on. Today BMTs are routine and in some cases are practically outpatient treatments. The development and approval of new drugs and therapies are exactly as fast as they should be. Want something faster, then work towards it. In other words: less talk, more walk.

vwinsyee 12y ago

The FDA has more than likely directly prevented hundreds of millions deaths worldwide. It's literally one of very few safeguards you can rely on to know that you're not eating poison. Amusingly, the top comment on a front page HN post [1] right now concerns one of the first court cases [2] that gave FDA some real power. Before this case, companies could sell a poison like emetic tartar and market it as a hangover drug. Selling stuff like this still happens today in countries without an FDA equivalent. [3] It even happens in countries with a drug regulatory body, but one that's weak. [4] As with all regulation, there's a balance between benefit/risk. As you point out, there is a financial and time burden of regulation. But with warts and all, the work that the FDA has done and currently does far outweighs these burdens. > The only good thing I can find to say about the bureaucrats at the FDA is that they respond to regional regulatory arbitrage - to medical tourism - by loosening their grip and letting things through. Or at least they do when said treatments are so widely available elsewhere in the world that the risk of looking bad by continuing to block them in the US is worse than the risk of looking bad because one of the outcomes of a normal, low error rate in medicine gets picked up by the press. Look at simple stem cell transplants, now available in the US these last couple of years, for a good example of this in practice. I'm not quite sure how to respond to this rant. But I'll point out findings from a 2012 NEJM study comparing the FDA to the EU's EMA and Canada's Health Canada: [5] "RESULTS: There were 510 applications for novel therapeutic agents approved from 2001 through 2010 — 225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States." [1] https://news.ycombinator.com/item?id=7758508 https://news.ycombinator.com/item?id=7758508 [2] https://en.wikipedia.org/wiki/United_States_v._11_1/4_Dozen_Packages_of_Articles_Labeled_in_Part_Mrs._Moffat%E2%80%99s_Shoo-Fly_Powders_for_Drunkenness https://en.wikipedia.org/wiki/United_States_v._11_1/4_Dozen_... [3] http://ijp-online.com/article.asp?issn=0253-7613;year=2007;volume=39;issue=4;spage=206;epage=207;aulast=Khan http://ijp-online.com/article.asp?issn=0253-7613;year=2007;v... [4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1151014/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1151014/ [5] http://www.nejm.org/doi/full/10.1056/NEJMsa1200223 http://www.nejm.org/doi/full/10.1056/NEJMsa1200223