4 ms·

> Have you not heard of the FDA? Upton Sinclair? I'm not going to get into the rest, but it's always worth mentioning that Upton Sinclair's book was a work of

by glenra 14y ago

> Have you not heard of the FDA? Upton Sinclair? I'm not going to get into the rest, but it's always worth mentioning that Upton Sinclair's book was a work of fiction. Most of the more disgusting and dangerous scenarios in the book were stuff that he invented to make the book more exciting and make it work better as propaganda. In short, he took dramatic license. And the FDA has quite likely killed more people than it has saved, and the USDA is essentially a way to subsidize the meatpacking industry by socializing some costs the industry would otherwise have to pay for itself. The net effect of such organizations on safety trends is, at the least, debatable. In the economic literature you often find that the rate of improvement decreases when a new regulatory institution starts managing some metric.

hackinthebochs 14y ago
>And the FDA has quite likely killed more people than it has saved, My immediate reaction is to say you're full of shit. But I'll hold off judgment and see if you can offer any shred of an argument that justifies this statement (not even asking for proof here).
- glenra 14y ago
  >> And the FDA has quite likely killed more people than it has saved, > My immediate reaction is to say you're full of shit. But I'll hold off judgment and see if you can offer any shred of an argument that justifies this statement (not even asking for proof here). The result of the FDA's post-1962 efforts has been to dramatically slow the rate of introduction of new drugs with essentially no effect on the average quality level of the drugs that do get introduced. Some new drugs still get through, but less than half as many per unit time and the FDA approval process delays the use of those drugs and makes them vastly more expensive to develop. These extra delays and higher costs are estimated to have caused, at a minimum, hundreds of thousands of preventable deaths. Good drugs save lives. Good drug information saves lives. The FDA often finds itself in the business of postponing the use of good drugs and preventing the dissemination of valid drug information. It has a powerful institutional bias towards inaction, but failing to approve good drugs in a timely manner kills people with at least as much certainly as does letting bad ones through. The notion that the modern FDA on net hurts us more than it helps is a pretty common belief among those economists who have studied the matter. I'd start with this general overview of the issues: http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsa... And then browse this site - lots of good stuff there: http://www.fdareview.org/ http://www.fdareview.org/ Bryan Caplan summarizes the general state of opinion as: "The public thinks the FDA is great. Regular economists think it's pretty good. And economists who specialize in the FDA think it's pretty bad." (source: http://econlog.econlib.org/archives/2005/04/fda_public_econ.html http://econlog.econlib.org/archives/2005/04/fda_public_econ.... )
  - hackinthebochs 14y ago
    Well, you certainly passed my low bar for rationale. I still can't agree though. Any argument based on statistics is going to be strongly biased against the FDA's current procedure. It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. Furthermore, a simple utilitarian argument about the net lives saved is not how most people would comprehend the situation. The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have. Being biased towards conservatism is appropriate at the scale of approving drugs and advertisement towards an entire country. Most people do not have the knowledge (even considering the internet) to appropriately evaluate a drug. I would wager that even doctors are not equipped to make this sort of safety evaluation for their patients. This is exactly the sort of thing that scientists taking a conservative approach should be doing.
    - glenra 14y ago
      Read the links I gave. I wasn't expecting you to be convinced just by what I wrote above. Before 1962, the FDA was tasked to verify safety but NOT to verify efficacy. Everything you just wrote only argues for that - for keeping drugs off the market that "kill someone" when they take it. It does NOT argue for keeping drugs off the market that we know are safe but can't yet conclusively prove work "better than a placebo" or "better than the standard treatment" in a study. After 1962, the FDA was tasked with determining efficacy. That is the part where the main problem lies. It turns out that proving that a drug probably doesn't kill people is MUCH easier than proving that a drug "works" at a level better than some metric. To prove a drug is safe, we have models and processes to calculate the LD50 and verify that people who take it at expected dose levels don't get sick. But to prove it's effective is hard. Hard enough that, in practice, insisting on it it kills hundreds of thousands of people. As one popular example, when the FDA approved beta blockers for use in preventing heart attacks, the FDA's own press release claimed that the newly approved drugs would save 10,000 lives per year, based on the results seen in Europe where the drugs had been in use for the prior decade. Economists look at that and notice that seems to suggest keeping that one class of drug OFF the market in the US after it had been approved in Europe killed on the order of 100,000 people all told. That is a very large death count. The worst death count we've ever seen due to drugs that "slipped through the cracks" prior to 1962 is a few orders of magnitude smaller than that. > The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have. That is true, but in this case the "intuition that most people have" is WRONG. By any rational standard, killing a hundred people by preventing them from getting their medicine is MUCH WORSE than killing one person by letting him get his medicine...even if we know who the people affected are in the latter case and not the former. That is approximately the sort of tradeoff we're looking at. > It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. It is difficult, but probably not impossible. One might look at the death rates attributed to medicinal prescription drugs under various regulatory regimes. In the US, you can compare drugs approved pre-1962 versus post-1962 - if the FDA's extra testing in the modern era were really valuable, there should be a bend in that curve in the correct direction (hint: there isn't). One can also compare with other countries that changed their regulatory regimes to be stricter or looser. Sure, you can't get an exact number of deaths, but you can make a plausible estimate. And this calculation WAY favors the FDA approach, due to the "what is seen and what is not seen" factor - people who die from taking a drug show up in newspaper headlines blaming the drug whereas people who die from NOT taking a drug do not show up in newspaper headlines blaming the FDA. :-) BTW, one simple huge improvement would be to just say that any drug approved for use by some other country's regulatory apparatus could be used here too with a mere "not yet approved by the FDA" warning label.
- glenra 14y ago
  Here's a much more specific response (from http://www.fdareview.org/harm.shtml http://www.fdareview.org/harm.shtml): Gieringer (1985) used data on drug disasters in countries with less-stringent drug regulations than the United States to create a ballpark estimate of the number of lives saved by the extra scrutiny induced by FDA requirements. He then computed a similar ballpark figure for the number of lives lost owing to drug delay: [T]he benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. . . . Given the uncertainties of the data, these results must be interpreted with caution, although it seems clear that the costs of regulation are substantial when compared to benefits. (196) In short, that paper estimates the FDA has killed more than twice as many people as it has saved. The reference: "Gieringer, D. H. 1984. Consumer Choice and FDA Drug Regulation. Ph.D. diss., Department of Engineering-Economic Systems, Stanford University." Here's another really good (and SHORT) general overview article that should address a lot of your concerns, "Economists Against the FDA" by Daniel B. Klein: http://www.scu.edu/civilsocietyinstitute/articles/upload/EconagainstFDA.pdf http://www.scu.edu/civilsocietyinstitute/articles/upload/Eco... When I said that delaying good drugs and good drug information kills, by drug information I meant stuff like this (from the Klein article): Today men with risk of heart trouble know to take half an aspirin a day. By 1988 it was well established that aspirin greatly reduces the risk of myocardial occlusion. But for years the FDA forbade aspirin makers from advertising that fact (the FDA still significantly restricts advertising about it). The FDA surely killed tens, and quite possibly hundreds, of thousands of Americans by this restriction alone."
  - hackinthebochs 14y ago
    Sorry, I didn't see this post earlier. The paper you link to makes some good arguments about the approval process. While I absolutely can't agree that the legal system can effectively screen out dangerous drugs without an oversight agency like the FDA, I can agree that the approval process for drugs to treat acute deadly diseases should be expedited in proportion to the severity of the condition it treats. The problem I see with these arguments is that they're using the worst case scenarios to argue abolishing the agency altogether. Aside from cases of life-saving drugs, the FDA also works to keep drugs and devices to treat non life-threatening or cosmetic cases from being harmful or deadly. An argument that beta-blocker drugs should have been approved faster is not an argument that your typical diet drug should have been. If we can draw a distinction between these cases, I'm more receptive to the arguments you're making. As far as aspirin for heart attacks goes, I can see the logic in not allowing a drug company to advertise its use for this purpose. Were doctors made aware of this use and were they trained to offer it as medication in appropriate cases? If so, then I think the system worked as it should. If not then there should be a system in place that disseminates such information to doctors and other medical professionals. But allowing drug companies to advertise directly is a massive can of worms. I don't think it should be allowed at all, let alone for "unproven" uses. People are not knowledgeable or responsible enough to evaluate the use of a drug based on uncertain information.
ahoyhere 14y ago
I have read a lot about Upton Sinclair but never heard the criticism that his novel was unrealistic. References? On the other hand, the inspectors assigned by President Roosevelt at the time… > Learning about the visit, owners had their workers thoroughly clean the factories prior to the inspection, but [Labor Commissioner Charles P. Neill and social worker James Bronson Reynolds] were still revolted by the conditions. Their oral report to Roosevelt supported much of what Sinclair portrayed in the novel... And Teddy Roosevelt apparently hated Sinclair, so somehow I trust his employees finding more than I trust you, random hackernewser. >... excepting the claim of workers falling into rendering vats… And as for that last bit, is it made up? Surely considering how many workers have accidentally been killed in other "crazy" accidents involving falling-into-stuff (e.g. ammonia/effluent holding tanks), which have been documented, it's not far fetched to believe that in an abusive, unsafe, and unsanitary environment, at least one person has died that way. So, I'm left with only one conclusion: You're making stuff up.
- glenra 14y ago
  > I have read a lot about Upton Sinclair but never heard the criticism that his novel was unrealistic. References? Try this summary: http://www.fee.org/the_freeman/detail/of-meat-and-myth http://www.fee.org/the_freeman/detail/of-meat-and-myth A few paragraphs relevant to what you just wrote: historians with an ideological axe to grind against the market usually ignore an authoritative 1906 report of the Department of Agriculture’s Bureau of Animal Husbandry. Its investigators provided a point-by-point refutation of the worst of Sinclair’s allegations, some of which they labeled as “willful and deliberate misrepresentations of fact,” “atrocious exaggeration,” and “not at all characteristic.” Instead, some of these same historians dwell on the Neill-Reynolds Report of the same year because it at least tentatively supported Sinclair. It turns out that neither Neill nor Reynolds had any experience in the meat-packing business and spent a grand total of two and a half weeks in the spring of 1906 investigating and preparing what turned out to be a carelessly written report with predetermined conclusions. Gabriel Kolko, a socialist but nonetheless a historian with a respect for facts, dismisses Sinclair as a propagandist and assails Neill and Reynolds as “two inexperienced Washington bureaucrats who freely admitted they knew nothing” of the meat-packing process. Their own subsequent testimony revealed that they had gone to Chicago with the intention of finding fault with industry practices so as to get a new inspection law passed. According to the popular myth, there were no government inspectors before Congress acted in response to The Jungle, and the greedy meat packers fought federal inspection all the way. The truth is that not only did government inspection exist, but meat packers themselves supported it and were in the forefront of the effort to extend it so as to ensnare their smaller, unregulated competitors. Oh, and the fact that to you "it's not far fetched to believe" something does not constitute evidence for it. :-)

by glenra 14y ago

hackinthebochs 14y ago

>And the FDA has quite likely killed more people than it has saved, My immediate reaction is to say you're full of shit. But I'll hold off judgment and see if you can offer any shred of an argument that justifies this statement (not even asking for proof here).

glenra 14y ago
>> And the FDA has quite likely killed more people than it has saved, > My immediate reaction is to say you're full of shit. But I'll hold off judgment and see if you can offer any shred of an argument that justifies this statement (not even asking for proof here). The result of the FDA's post-1962 efforts has been to dramatically slow the rate of introduction of new drugs with essentially no effect on the average quality level of the drugs that do get introduced. Some new drugs still get through, but less than half as many per unit time and the FDA approval process delays the use of those drugs and makes them vastly more expensive to develop. These extra delays and higher costs are estimated to have caused, at a minimum, hundreds of thousands of preventable deaths. Good drugs save lives. Good drug information saves lives. The FDA often finds itself in the business of postponing the use of good drugs and preventing the dissemination of valid drug information. It has a powerful institutional bias towards inaction, but failing to approve good drugs in a timely manner kills people with at least as much certainly as does letting bad ones through. The notion that the modern FDA on net hurts us more than it helps is a pretty common belief among those economists who have studied the matter. I'd start with this general overview of the issues: http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsa... And then browse this site - lots of good stuff there: http://www.fdareview.org/ http://www.fdareview.org/ Bryan Caplan summarizes the general state of opinion as: "The public thinks the FDA is great. Regular economists think it's pretty good. And economists who specialize in the FDA think it's pretty bad." (source: http://econlog.econlib.org/archives/2005/04/fda_public_econ.html http://econlog.econlib.org/archives/2005/04/fda_public_econ.... )
- hackinthebochs 14y ago
  Well, you certainly passed my low bar for rationale. I still can't agree though. Any argument based on statistics is going to be strongly biased against the FDA's current procedure. It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. Furthermore, a simple utilitarian argument about the net lives saved is not how most people would comprehend the situation. The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have. Being biased towards conservatism is appropriate at the scale of approving drugs and advertisement towards an entire country. Most people do not have the knowledge (even considering the internet) to appropriately evaluate a drug. I would wager that even doctors are not equipped to make this sort of safety evaluation for their patients. This is exactly the sort of thing that scientists taking a conservative approach should be doing.
  - glenra 14y ago
    Read the links I gave. I wasn't expecting you to be convinced just by what I wrote above. Before 1962, the FDA was tasked to verify safety but NOT to verify efficacy. Everything you just wrote only argues for that - for keeping drugs off the market that "kill someone" when they take it. It does NOT argue for keeping drugs off the market that we know are safe but can't yet conclusively prove work "better than a placebo" or "better than the standard treatment" in a study. After 1962, the FDA was tasked with determining efficacy. That is the part where the main problem lies. It turns out that proving that a drug probably doesn't kill people is MUCH easier than proving that a drug "works" at a level better than some metric. To prove a drug is safe, we have models and processes to calculate the LD50 and verify that people who take it at expected dose levels don't get sick. But to prove it's effective is hard. Hard enough that, in practice, insisting on it it kills hundreds of thousands of people. As one popular example, when the FDA approved beta blockers for use in preventing heart attacks, the FDA's own press release claimed that the newly approved drugs would save 10,000 lives per year, based on the results seen in Europe where the drugs had been in use for the prior decade. Economists look at that and notice that seems to suggest keeping that one class of drug OFF the market in the US after it had been approved in Europe killed on the order of 100,000 people all told. That is a very large death count. The worst death count we've ever seen due to drugs that "slipped through the cracks" prior to 1962 is a few orders of magnitude smaller than that. > The situation where a drug kills someone will be weighed much more gravely than the situation where a life-saving drug was kept from you because it couldn't be proven effective. So a net-lives-saved calculation simply doesn't capture the intuition that most people have. That is true, but in this case the "intuition that most people have" is WRONG. By any rational standard, killing a hundred people by preventing them from getting their medicine is MUCH WORSE than killing one person by letting him get his medicine...even if we know who the people affected are in the latter case and not the former. That is approximately the sort of tradeoff we're looking at. > It is impossible to predict how many deaths were prevented from keeping dangerous drugs off the market, so it is impossible to make a meaningful comparison. It is difficult, but probably not impossible. One might look at the death rates attributed to medicinal prescription drugs under various regulatory regimes. In the US, you can compare drugs approved pre-1962 versus post-1962 - if the FDA's extra testing in the modern era were really valuable, there should be a bend in that curve in the correct direction (hint: there isn't). One can also compare with other countries that changed their regulatory regimes to be stricter or looser. Sure, you can't get an exact number of deaths, but you can make a plausible estimate. And this calculation WAY favors the FDA approach, due to the "what is seen and what is not seen" factor - people who die from taking a drug show up in newspaper headlines blaming the drug whereas people who die from NOT taking a drug do not show up in newspaper headlines blaming the FDA. :-) BTW, one simple huge improvement would be to just say that any drug approved for use by some other country's regulatory apparatus could be used here too with a mere "not yet approved by the FDA" warning label.
glenra 14y ago
Here's a much more specific response (from http://www.fdareview.org/harm.shtml http://www.fdareview.org/harm.shtml): Gieringer (1985) used data on drug disasters in countries with less-stringent drug regulations than the United States to create a ballpark estimate of the number of lives saved by the extra scrutiny induced by FDA requirements. He then computed a similar ballpark figure for the number of lives lost owing to drug delay: [T]he benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. . . . Given the uncertainties of the data, these results must be interpreted with caution, although it seems clear that the costs of regulation are substantial when compared to benefits. (196) In short, that paper estimates the FDA has killed more than twice as many people as it has saved. The reference: "Gieringer, D. H. 1984. Consumer Choice and FDA Drug Regulation. Ph.D. diss., Department of Engineering-Economic Systems, Stanford University." Here's another really good (and SHORT) general overview article that should address a lot of your concerns, "Economists Against the FDA" by Daniel B. Klein: http://www.scu.edu/civilsocietyinstitute/articles/upload/EconagainstFDA.pdf http://www.scu.edu/civilsocietyinstitute/articles/upload/Eco... When I said that delaying good drugs and good drug information kills, by drug information I meant stuff like this (from the Klein article): Today men with risk of heart trouble know to take half an aspirin a day. By 1988 it was well established that aspirin greatly reduces the risk of myocardial occlusion. But for years the FDA forbade aspirin makers from advertising that fact (the FDA still significantly restricts advertising about it). The FDA surely killed tens, and quite possibly hundreds, of thousands of Americans by this restriction alone."
- hackinthebochs 14y ago
  Sorry, I didn't see this post earlier. The paper you link to makes some good arguments about the approval process. While I absolutely can't agree that the legal system can effectively screen out dangerous drugs without an oversight agency like the FDA, I can agree that the approval process for drugs to treat acute deadly diseases should be expedited in proportion to the severity of the condition it treats. The problem I see with these arguments is that they're using the worst case scenarios to argue abolishing the agency altogether. Aside from cases of life-saving drugs, the FDA also works to keep drugs and devices to treat non life-threatening or cosmetic cases from being harmful or deadly. An argument that beta-blocker drugs should have been approved faster is not an argument that your typical diet drug should have been. If we can draw a distinction between these cases, I'm more receptive to the arguments you're making. As far as aspirin for heart attacks goes, I can see the logic in not allowing a drug company to advertise its use for this purpose. Were doctors made aware of this use and were they trained to offer it as medication in appropriate cases? If so, then I think the system worked as it should. If not then there should be a system in place that disseminates such information to doctors and other medical professionals. But allowing drug companies to advertise directly is a massive can of worms. I don't think it should be allowed at all, let alone for "unproven" uses. People are not knowledgeable or responsible enough to evaluate the use of a drug based on uncertain information.

ahoyhere 14y ago

I have read a lot about Upton Sinclair but never heard the criticism that his novel was unrealistic. References? On the other hand, the inspectors assigned by President Roosevelt at the time… > Learning about the visit, owners had their workers thoroughly clean the factories prior to the inspection, but [Labor Commissioner Charles P. Neill and social worker James Bronson Reynolds] were still revolted by the conditions. Their oral report to Roosevelt supported much of what Sinclair portrayed in the novel... And Teddy Roosevelt apparently hated Sinclair, so somehow I trust his employees finding more than I trust you, random hackernewser. >... excepting the claim of workers falling into rendering vats… And as for that last bit, is it made up? Surely considering how many workers have accidentally been killed in other "crazy" accidents involving falling-into-stuff (e.g. ammonia/effluent holding tanks), which have been documented, it's not far fetched to believe that in an abusive, unsafe, and unsanitary environment, at least one person has died that way. So, I'm left with only one conclusion: You're making stuff up.

glenra 14y ago
> I have read a lot about Upton Sinclair but never heard the criticism that his novel was unrealistic. References? Try this summary: http://www.fee.org/the_freeman/detail/of-meat-and-myth http://www.fee.org/the_freeman/detail/of-meat-and-myth A few paragraphs relevant to what you just wrote: historians with an ideological axe to grind against the market usually ignore an authoritative 1906 report of the Department of Agriculture’s Bureau of Animal Husbandry. Its investigators provided a point-by-point refutation of the worst of Sinclair’s allegations, some of which they labeled as “willful and deliberate misrepresentations of fact,” “atrocious exaggeration,” and “not at all characteristic.” Instead, some of these same historians dwell on the Neill-Reynolds Report of the same year because it at least tentatively supported Sinclair. It turns out that neither Neill nor Reynolds had any experience in the meat-packing business and spent a grand total of two and a half weeks in the spring of 1906 investigating and preparing what turned out to be a carelessly written report with predetermined conclusions. Gabriel Kolko, a socialist but nonetheless a historian with a respect for facts, dismisses Sinclair as a propagandist and assails Neill and Reynolds as “two inexperienced Washington bureaucrats who freely admitted they knew nothing” of the meat-packing process. Their own subsequent testimony revealed that they had gone to Chicago with the intention of finding fault with industry practices so as to get a new inspection law passed. According to the popular myth, there were no government inspectors before Congress acted in response to The Jungle, and the greedy meat packers fought federal inspection all the way. The truth is that not only did government inspection exist, but meat packers themselves supported it and were in the forefront of the effort to extend it so as to ensnare their smaller, unregulated competitors. Oh, and the fact that to you "it's not far fetched to believe" something does not constitute evidence for it. :-)