Deafening Silence

Dan Klein harps on a too-rarely-asked question:

Counterparts to the FDA function in other countries. The FDA could adopt a standing policy that drugs permitted in Europe, Canada, Japan, Australia, etc. automatically become permitted in the US. Why doesn’t the FDA adopt such a policy? Is it because a drug that is safe and effective in Australia, Canada, or France may not be safe and effective in the United States?

Alex Tabarrok, in the office next door, says he often harps on this and has never heard a reasonable counter-argument.  I’m especially fascinated by situations like this, where a devastating argument against a status quo policy is met by complete silence and disinterest.  Why don’t intellectuals feel any need to respond to such arguments?  How can we make such silences more audible to more people?

Kids often analogously complain  "But Billy’s parents let him do X."  And they should add, "What makes you think you know better than Billy’s parents?"  Are we similarly just overconfident in the judgment of "our" regulators? 

Alex also harps on another tough question:

What can we learn about the need for efficacy requirements from the pervasive experience of off-label medicine, which has no FDA efficacy certification? The thrust of Tabarrok’s argument is that off-label seems to work quite well and so why not drop efficacy requirements entirely?

Alex tells me the two best counter arguments are that off-label uses are often similar to on-label uses, and that drug firms have low incentives to run tests near the end of a drug’s patent lifetime.  But then why not approve only similar on-label uses and approve all uses of unpatentable drugs (that have passed safety tests)? 

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  • Abigail

    It could be a legal problem. The foreign provider has no duty of care to the US Government. This does not prevent the WHO licencing drugs: but the best solution for a rich country may be different from the best solution for a poor country.

    What if a drug is safe in Australia, but not France, Germany, the UK and Zimbabwe?

    Taking medicine is a risk. US citizens want US protection from that risk. How can they trust Britain and France? Perhaps Britain and France are willing to take risks which for the US should be unacceptable.

  • http://profile.typekey.com/chronophasiac/ Mike

    From the Wikipedia article on Thalidomide:

    “Thalidomide was developed by German pharmaceutical company Grünenthal in Stolberg (Rhineland) near Aachen. It was sold from 1957 to 1961 in almost 50 countries under at least 40 names, including Distaval, Talimol, Nibrol, Sedimide, Quietoplex, Contergan, Neurosedyn, and Softenon. Thalidomide was chiefly sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep. Before its release, inadequate tests were performed to assess the drug’s safety, with catastrophic results for the children of women who had taken thalidomide during their pregnancies.

    From 1956 to 1962, approximately 10,000 children in Africa and Europe were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy.

    The impact in the United States was minimized when Frances Oldham Kelsey refused FDA-approval for an application from Richardson Merrell to market it saying it needed more study. Richardson Merrell gave the tablets to doctors with the understanding that it was still under investigation. Only 17 children in the U.S. were born with the defects.”

  • http://www.scottaaronson.com Scott Aaronson

    Someone with a different view might ask: why shouldn’t all drugs banned in Europe, Japan, and Australia also be banned in the US, and why isn’t anyone asking that question? In both cases, “politics” and “drug company money” suggest themselves as possible answers…

  • Cyrus

    A weakness in the off-label analogy is that (unless the off-label use involves significant changes in dosing, route, etc…) negative side effects of the off label use are likely to be about the same as those determined for on-label use. Even if we haven’t gone through the regulatory hurdles of showing that the off-label use works, we have gone through the hurdles of showing that it’s safe-ish.

  • Aron

    Isn’t it quite likely that approval (and evidence and arguments made) in cases for foreign FDA-equivalents is accepted as strong evidence for drug review decisions here? I’m not seeing the problem with an extra layer of review added here so long as it makes logical use of all information, which can include the judgements of others.

  • http://blog.greenideas.com botogol

    Why not print the details on the label and let the consumer decide

    Approved in UK, France, Germany, USA and Japan
    Banned in Zimbabwe, Iran, North Korea and Poland
    Undecided in Canada.

    Clearly you’d take this one … right?

  • http://zbooks.blogspot.com Zubon

    Cyrus, the efficacy question is separate from the safety question. It is not an analogy. The argument is for abandoning FDA efficacy testing and testing only for safety.

  • http://hanson.gmu.edu Robin Hanson

    Scott, the problem is that three signals, approve, disapprove, no opinion, are usually mapped onto two choices, allow or not allow, so we have to pay attention to the default. If the default is to not allow, non-allowance combines both disapproval and no-opinion. So if we set our rule not to allow anything not allowed by two other nations, we’d be not allowing things just because that other nation didn’t have an opinion.

    Cyrus, Zubon is right, we are talking about efficacy not safety here.

    Abigail, the issue is what our laws should be.

  • http://drchip.wordpress.com/ retired urologist

    off-label uses are often similar to on-label uses, and that drug firms have low incentives to run tests near the end of a drug’s patent lifetime

    Synthetic prostaglandin E1 was developed by Upjohn (Prostin-VR) in the early ’80’s as an orphan drug for augmenting the treatment of certain congenital heart abnormalities in newborns. The maximum potential US market was about 1500 babies annually. Coincidentally, British physiologist Giles Brindley in 1983 demonstrated the efficacy of injectable penile pharmacotherapy. When it was later discovered that the mechanism of initiating erections was nitric oxide donation, Prostin-VR was the near-ideal injectable drug. The potential US market was about 40 million men (this was before Viagra). I used it both for testing and for treatment in my patients, at a cost of less than 30 cents per microgram. Upjohn responded by cutting off all sales of Prostin-VR except to hospitals, remarketing the drug under the name “Caverject”, and raising the price to about $1.50 per microgram. The cost of a typical dose for my patients went from $6 to $30 for the exact same medication. Prostin-VR’s patent had long expired, but they were able to renew it under the new name. Draw you own conclusions.

  • Lara Foster

    This matter seems simple to solve. The FDA wants control over setting its own standards for efficacy and safety, so if it ‘automatically’ approves drugs based on what other countries do, it will be abandoning this control. Now, if the standards of proof for efficacy and safety are the same or higher in other countries, then the US should not need to repeat these trials. What seems wisest to me is for the FDA to set up a review-board for clinical trials conducted outside of the US to determine whether or not the research and conclusions deriving therefrom are sound, and if they are, to forgo expensive and time-consuming clinical trials in the US.

    Now, retired uroligist brings up a good point, which is that the US drug companies might NOT want for foreign drugs to be quickly accepted in the US, since they will cut into their profit margins. His story about prostin-VR is remarkably similar to that of the drug Dimebon, which has been used in Russia as a crappy antihistamine since the 1980s. Recently, clinical trials in Russia have shown Dimebon to dramatically reduce the progression of Alzheimer’s disease, much more than any existing therepy. So what happened? The US drug company Medivation bought the rights to the drug, repatented it, and are now undergoing clinical trials in the US. Now a drug that used to cost 10 cents in Russia is going to be sold on a US market for god-knows how much by a company that didn’t even need to underwrite the cost of developing it. Where is the public outrage there?

  • http://jewishatheist.blogspot.com JewishAtheist

    I thought it was obvious. Less competition for domestic pharmaceutical companies.

  • http://www.hopeanon.typepad.com Hopefully Anonymous

    Robin and Zubon, is it rational to separate out efficacy testing from safety tasting? Rationally, doesn’t the value of the drug hinge on the efficacy/safety ratio?

  • http://pancrit.org Chris Hibbert

    “But Billy’s parents let him do X. What makes you think you know better than Billy’s parents?”

    “Billy’s parents have different values than we do.”

    “Billy’s taller than you. When you’re as tall as Billy, we will probably let you do X, too.”

    “Billy’s more responsible than you. When you’re as mature as Billy, we will probably let you do X, too.”

    “Billy’s parents are being irresponsible. If they didn’t have to work so much, they might be able to do a better job raising him.”

    “You’re not Billy, and we’re not Billy’s parents. The answer is still no.”

    I’m not sure this is such a great analogy. Parents always have a reason, and with their kids, it doesn’t have to be a good one. Regulators ought to have a good reason and it shouldn’t rely on their greater responsibility or our lower status.

    I think the argument for reviewing the data is strong, and the argument for following decisions made in countries with solid decision-making processes is almost as strong. A conceivable process is to create a bureaucracy responsible for reviewing other countries’ processes and standards. They’d then have an incentive to at least occasionally say ‘yes’. And each ‘yes’ would clear a lot more approved drugs at a much lower cost than any other decision I can think of.

  • http://shagbark.livejournal.com Phil Goetz

    Wow, I hardly know where to begin with this one.

    For starters, how much sense does it make that I am not allowed to take Vioxx, the only medicine that was able to reduce my chronic, continual, intense pain a few years ago, because it kills .03% of people who take it (but much less chance of killing me, since I am at low risk for heart problems); yet I can buy cigarettes over the counter, which have an 80% chance of killing me? Yes, you read that right. Here are the figures:

    Deaths the FDA thinks Vioxx may have contributed to from 1999 to 2003: 27,785
    Vioxx prescriptions in that period: 92,800,000
    Deaths from smoking per year in the US: 440,000
    Total deaths in 2005 in the US: 2,448,017 (CDC)
    Fraction caused by smoking: .180
    Fraction of people in the US who smoke: 44.5/300 = .148
    Fraction of deaths of smokers caused by smoking: .148 / .180 = .82

    More importantly to me, what about personalized medicine?
    Research institutes around the world are working to learn how to predict how a drug will affect a patient based on their genome. But what is the point of developing drugs that are safe and effective for people with particular gene alleles or SNPs, when they need to be proven safe and effective for all people in order to be approved by the FDA? The FDA’s regulatory policy makes genetic medicine impossible.

    A study out last week, in which they sequenced genomes from human cancer cells, found that on average, 80 different genes are mutated in any given breast cancer. The researchers think (based on a lot of statistical assumptions) that only 12 of these are causal. What this means is that, if you have a “type” of cancer, and someone has done a trial of a drug on 100,000 patients with that “type” of cancer, the odds that anyone in the trial had the same genetic disease that you do are low. This means that efficacy must be predicted based on protein-folding simulations for your particular mutations, and on statistical models. The FDA is a very long way away from allowing someone to take a drug because a computer model said it would probably work.

  • http://shagbark.livejournal.com Phil Goetz

    What especially galls me is that people continually whine about the high cost of drugs in the US, yet never connect the high cost of drugs with the high cost of getting drugs approved. I have had this discussion many times with intelligent, educated Americans; and I have never gotten one to admit either that lowering the cost of approval might be a good idea, or that they are willing to pay current-level drug prices for current levels of drug safety.

  • http://shagbark.livejournal.com Phil Goetz

    Correction: Because smoking is declining, probably more than 15% of the elderly, who are doing most of the dying, smoke.

    This paper: http://content.nejm.org/cgi/content/full/337/24/1705
    studied only the elderly, and indicates that cigarettes have only a 50% chance of killing you.

  • Doug S.

    I suspect that smoking is still legal largely because alcohol prohibition caused a hell of a lot of problems back in the 1920s and we aren’t eager to repeat the experience.

    (Even though we pretty much are, but that’s another story.)

    I am not allowed to take Vioxx, the only medicine that was able to reduce my chronic, continual, intense pain a few years ago, because it kills .03% of people who take it (but much less chance of killing me, since I am at low risk for heart problems)

    I’m sorry to hear that… have Celebrex (celecoxib) and Bextra (valdecoxib), two other drugs with similar mechanisms of action, failed for you?

  • http://occludedsun.wordpress.com Caledonian

    You might as well ask why taking the judgement of others on faith is less useful than performing the testing and questioning yourself.

    Either you already know the answer and simply haven’t thought enough about the question to realize it… or you don’t know the answer at all, in which case we’re unlikely to be able to explain it to you.

  • Cyan

    Caledonian,

    Taking the judgment of others on “faith” (or rather, belief in their competence grounded in evidence) may actually be more useful (i.e., have higher expected utility) than performing the testing and questioning oneself. Robin’s observation isn’t anywhere near as trivial as you seem to think.

  • http://occludedsun.wordpress.com Caledonian

    The problem, Cyan, is that when such strategies have been attempted in real life, it usually ends up as groupthink: everyone presumes the competence of everyone else, parrots what everyone else says, and the result is nothing but an echo chamber.

    In order to keep inquiry healthy, someone has to be willing not to rely on past behavior, but to actually go out and form justified conclusions themselves, to become primary sources rather than secondary or tertiary.

  • Cyan

    Caledonian,

    Yes, sometimes that happens. But most of the time, I do in fact trust my mechanic to fix my car.

  • http://shagbark.livejournal.com Phil Goetz

    Well-put, Cyan!

  • Lord

    Perhaps the silence is deafening due to deafness. Mike nailed it.

  • Lord

    As far as Vioxx goes, the risk increases with dosage and with time so even if you don’t have heart problems now, you will develop them over time.

  • gwern

    Take into account other countries’ drug approvals?

    Madness – Why, why, that’d be like the Supreme Court considering foreign law in their decisions! Or having a decent respect for the opinions of mankind, or some such unAmerican foolishness.

  • Philip Boncer

    Zubin wrote: “Cyrus, the efficacy question is separate from the safety question. It is not an analogy. The argument is for abandoning FDA efficacy testing and testing only for safety.”

    The problem with this is that any drug is a cost/benefit calculation. The acceptable side effect profile and safety levels are very different for an effective drug for a life-threatening condition than for a minor ailment. No one would possibly call it worthwhile if a cold medicine affected you like chemotherapy does; yet for treating major cancer that’s an acceptable thing to endure if necessary.

    Lara Foster wrote: “The US drug company Medivation bought the rights to the drug, repatented it, and are now undergoing clinical trials in the US. Now a drug that used to cost 10 cents in Russia is going to be sold on a US market for god-knows how much by a company that didn’t even need to underwrite the cost of developing it. Where is the public outrage there?”

    Except that the *biggest* cost of developing a drug IS the clinical trials, *especially* for a long term disease like Alzheimers. So the U.S. drug company IS underwriting the cost of developing it for this application, and would not have any incentive to do so if it couldn’t then recoup that cost in the market.

    Chris Hibbert wrote: “I think the argument for reviewing the data is strong, and the argument for following decisions made in countries with solid decision-making processes is almost as strong. A conceivable process is to create a bureaucracy responsible for reviewing other countries’ processes and standards. They’d then have an incentive to at least occasionally say ‘yes’. And each ‘yes’ would clear a lot more approved drugs at a much lower cost than any other decision I can think of.”

    This makes sense. I think a big part of the lack of progress in this sort of useful harmonization is that the government simply isn’t very interested in being efficient or in reducing its own size and workload. Bureucracies become self-justifying and do not want to work themselves out of jobs.

    PhilB

  • http://peco.wordpress.com peco
  • http://occludedsun.wordpress.com Caledonian

    Yes, sometimes that happens. But most of the time, I do in fact trust my mechanic to fix my car.

    Your mechanic personally inspects your car to determine what the problem(s) with it might be. As an example of what you’re talking about, it’s not a very good one.

    No matter what authority you pick to make your decisions for you, you still have to pick an authority. How can that choice be given to an authority? The ultimate responsibility is still your own.

  • Jayson Virissimo

    “It could be a legal problem. The foreign provider has no duty of care to the US Government. This does not prevent the WHO licencing drugs: but the best solution for a rich country may be different from the best solution for a poor country.

    What if a drug is safe in Australia, but not France, Germany, the UK and Zimbabwe?

    Taking medicine is a risk. US citizens want US protection from that risk. How can they trust Britain and France? Perhaps Britain and France are willing to take risks which for the US should be unacceptable.” -abigail

    I am a U.S. citizen and I don’t want “protection” from the FDA. What I want is for them to stop using force to prevent me from taking drugs that will make me healthier as determined by my own judgment! Please stop “protecting” me. It hurts.

  • Cyan

    As an example of what you’re talking about, it’s not a very good one.

    It may not be a good example of what you’re talking about, but it’s an entirely reasonable example of what I’m talking about. Not “faith in authority” — trust grounded in evidence. Presumably the FDA is competent to assess whether other health agencies’ certification procedures are adequate.

  • Doug S.

    Isn’t there enough snake oil in the world already?

  • http://www.cawtech.freeserve.co.uk Alan Crowe

    Mike offers the example of Thalidomide. It is clearly on
    point, but is it part of the answer or part of the question?

    The decisions of drugs regulators produce both great
    benefits, as when they block drugs that turn out to be
    harmful, and do great harm, as when people die awaiting
    approval of an apparently life saving drug that does indeed
    fulfil its promise. The fundamental challenge for drugs
    regulation is to resist the temptation to win one or other
    Pyrrhic victory.

    You can win the battle to protect the public from harmful
    medicines by a blanket conservatism that pays too great a
    price in terms of beneficial drugs delayed. You can win the
    race for timely approval with a gung-ho approach that pays
    too great a price in terms of harmful drugs, rashly
    approved.

    A convincing argument that Americans are right to trust the
    FDA alone can only ever be a clumsy two-headed
    argument. One head points to successes at harm prevention,
    while the other head discusses the price paid in regulatory
    expense and delay and shows that it was not excessive.

    The tale that I’ve been told in relation to thalidomide and
    the FDA is that their success ushered in an era of excessive
    caution. The standard example is the class of drugs known as
    beta-blockers, which are aimed at reducing heart attack
    risks. These drugs were unavailable in the U.S. from 1967 to
    1976 as a result of FDA policies. It is estimated that this
    delay cost 10,000 lives per year, or a total of 100,000
    needless deaths. (Sam Kazman, “Deadly Overcaution: FDA’s
    Drug Approval Process,” Journal of Regulation and Social
    Costs, Vol. 1, No. 1 (September 1990)). Well, maybe. Its not
    my field and I’ve not actually read the paper I cite.

    I want to focus on my question “Is Mike’s citing of
    Thalidomide part of the answer or part of the question?”

    Hanson prods hard by asking “I’m especially fascinated by
    situations like this, where a devastating argument against a
    status quo policy is met by complete silence and
    disinterest. Why don’t intellectuals feel any need to
    respond to such arguments?” This sharp goading does at last
    get a response: it’s thalidomide, stupid!

    So I sit at my computer, spectating this debate, and I can
    see that the response just doesn’t work. The situation is
    all too obviously one that calls for a trade-off, and yet
    the response is one-sided. It is a cost-benefit analysis
    without the costs. The deformed babies shut down the
    argument and the middle-aged men dying of heart attacks die
    out of public view, mourned only by family and friends.

    In conclusion, I think that Mike’s response is part of the
    question not part of the answer. Hanson notes the strange
    silence. It is simply an aspect of this silence that if you
    keep prodding you get an answer that cannot work because it
    has the wrong logical form.

  • http://zbooks.blogspot.com Zubon

    Hopefully Anonymous and Philip Boncer,

    It makes a great deal of sense to test both at once. As you say, the value of the drug depends on the benefit-cost analysis. I would want both pieces of information before deciding to use it myself.

    The standards I hold for my own use are different from the standards I hold for making something illegal. I do not drink alcohol; I do not like the benefit-cost trade-off there; I do not believe the safety testing on alcohol would be so negative as to drive it off the market. Reference Vioxx above: Phil Goetz thinks it would be an acceptable trade-off for him, but the FDA has decided that no one gets to make that decision.

    Again, two separate questions: should you use x? Should everyone be legally barred from using x?

  • http://occludedsun.wordpress.com Caledonian

    A lot of bureaucrats were involved in the decisions regarding what the US drug policies should be.

    Why does Robin Hanson think his judgement is better than those bureaucrats’?

    The argument from majjority consensus cuts both ways.

  • http://occludedsun.wordpress.com Caledonian

    Presumably the FDA is competent to assess whether other health agencies’ certification procedures are adequate.

    Granting that presumption for the sake of argument: The FDA does not take those health agencies’ certification procedures into account when making its decisions.

    If you grant the FDA is capable of making a good judgment on that matter, why argue in favor of the idea that the judgment it *has made* is bad? Shouldn’t you accept the decision they’ve come to, on the basis of trust based on evidence?

  • http://zbooks.blogspot.com Zubon

    Caledonian, is there reason to believe that the FDA has the authority to consider other health agencies’ certification procedures? I do not know the relevant legislation, but I would not be surprised to find that Congress has eliminated that option.

    That would address the second point, if the FDA is not allowed to exert its judgment on that question. On the first point, it would pass the recursive buck to, “Why does Robin Hanson think his judgment is better than those Congressmen?” But that seems like a dead question, given how likely anyone on the internet is to defer to the legislature’s judgment.

  • Sean C.

    I have friends who work in the Canadian equivalent of the FDA. They actually run their inspections differently from the FDA, on purpose, to cover off things that the FDA might miss.

  • Phil Boncer

    Zubon wrote: “The standards I hold for my own use are different from the standards I hold for making something illegal. I do not drink alcohol; I do not like the benefit-cost trade-off there; I do not believe the safety testing on alcohol would be so negative as to drive it off the market. Reference Vioxx above: Phil Goetz thinks it would be an acceptable trade-off for him, but the FDA has decided that no one gets to make that decision.

    Again, two separate questions: should you use x? Should everyone be legally barred from using x?”

    I agree with you. My argument there was about someone’s proposal to test only for safety.

    I think that all drugs should be legal, and that the FDA should be more like, say, UL — it would certify drugs so that people and doctors can have more confidence in them, but no one should be legally prohibited from choosing what to put in his own body.

    PhilB

  • egl

    “Reference Vioxx above: Phil Goetz thinks it would be an acceptable trade-off for him, but the FDA has decided that no one gets to make that decision.” Merck made that decision. One can speculate about what the FDA might have done, but in this case the manufacturer acted first.

  • http://profile.typekey.com/bayesian/ Peter McCluskey

    Robin, you made a comment here indicating that you think drugs are less valuable than most of us think.
    I’m wondering whether that view can be reconciled with your interest here in more access to drugs and the view Eliezer mentioned:

    According to this source, the FDA’s longer approval process prevents 5,000 casualties per year by screening off medications found to be harmful, and causes at least 20,000-120,000 casualties per year

    Are the benefits of new drugs low, but still positive enough to be an exception to your general rule that the marginal benefit of medical spending is zero? Or is the benefit of new drugs unrelated to how much is spent on medicine?

  • http://zbooks.blogpost.com Zubon

    Merck made that decision. One can speculate about what the FDA might have done, but in this case the manufacturer acted first.

    You are absolutely right and I am wrong. Wikipedia also tells me that an FDA advisory committe voted 17-15 that Vioxx should be brought back because the benefits outweighed the costs. Updated.

    I will avoid the tort reform debate on why the costs to Merck outweighed the benefits to Merck.

  • http://occludedsun.wordpress.com Caledonian

    I have friends who work in the Canadian equivalent of the FDA. They actually run their inspections differently from the FDA, on purpose, to cover off things that the FDA might miss.

    So they think they’re smarter than the FDA, eh?

    Damn straight. Good for them.

  • http://hanson.gmu.edu Robin Hanson

    Peter, while drug spending has better support in the literature for giving health benefits than overall spending, yes my relative skepticism about drug benefits makes me see less at stake in drug regulation. But something is at stake, and it is a nice clear example of paternalism to help us understand paternalism more generally.

  • Jor

    There is a pretty simple answer to this — America is clearly the leader in bio-medicine. The NIH is the largest biomedical funding research agency in the world. The FDA most likely has much more qualified people making these decisions than its counter parts. The FDA also recently has come under scrutiny for some conflicts of interest. I’m not sure why I would expect drug regulatory industries in smaller countries to be more instituationally sound. In an ideal world, one supreme drug-regulatory agency would make the decision for everyone — but we live on Earth.

    This type of “multiple review” inefficiency is in lots of systems. Peer Review. Job Interviews, etc. It’s just not financially important enough to whine about.

  • Jor

    BTW, other COX II inhibitors are still on the market. Vioxx was not the only one. Merck fudged the safety data on it, in their submission to the FDA. That might be part of the reason they decided to withdraw it themselves.

  • Douglas Knight

    Here is a scenario for separate drug regulations that actually operates in the real world, but by no mean a large part of why things are organized as they are. Drug effects can vary racially and Japan’s regulatory apparatus uses its control of the market to force studies of Japanese samples, especially in the case of “me-too” drugs. (By “scenario,” I mean merely what happens; I make no claims about market failure.)

  • Cyan

    If you grant the FDA is capable of making a good judgment on that matter, why argue in favor of the idea that the judgment it *has made* is bad? Shouldn’t you accept the decision they’ve come to, on the basis of trust based on evidence?

    You and I have been arguing past each other. I took as a premise that the FDA requires duplication (at great expense) of previous findings in other countries, but that the findings are typically in agreement. You seem to be talking about the case where the findings are in disagreement, which I assumed to be rare on account of stability of the causal mechanism. Hmm.

  • Douglas Knight

    duplication (at great expense) of previous findings in other countries

    A lot of people on this thread seem to believe that, but it’s not true: they use the same studies.

  • EGL

    Since approvals are made by national agencies, nationally aggregated incentive determines willingness to fund the (expensive) review process. The U.S. is often the largest market in sales and patients and places high valuations on life and thus has the highest aggregated incentive to fund “correct” decisions. Under a policy that the FDA would accept approval in certain other countries, drug companies would have a strong incentive to find the review agency with the least ability to stage a critical review. It probably won’t be the U.S FDA.

    So yes, I might know better than Billy’s parents if I have more time and money to spend investigating.

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