Three Cheers for Regulation

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54 Responses

  1. Avatar Murali says:

    There are some things I’m less libertarian about. Drug and patient safety is one of them.Report

    • Avatar Dave in reply to Murali says:

      @murali

      I’m not sure why cheering for regulation in cases of safety makes someone less libertarian, but then again, I’ve never been one for dogma.

      Hell, part of me would like to see weight loss supplements pulled from the market if not marketed with more stringent disclosure requirements.Report

      • Avatar Saul Degraw in reply to Dave says:

        @dave

        The way I’ve heard it from true believers in little to no regulation is that but for the FDA, the market would be filled with all sorts of wonderful medicines that could cure basically everything. The tone is utopian and conspiratorial.Report

        • Avatar LeeEsq in reply to Saul Degraw says:

          Some of them are like this. Others take a more nuanced tone and argue that regulation keeps as many good drugs off the market as bad drugs and raises the price of all drugs. Considering the amount of snake oil passing as medicine and adulterated food on the market before the FDA came into existence, this is clearly a place where regulation is needed.Report

          • Avatar Damon in reply to LeeEsq says:

            @leeesq @saul-degraw

            “Others take a more nuanced tone and argue that regulation keeps as many good drugs off the market as bad drugs and raises the price of all drugs.”

            And let’s not forget that “the number of lives saved” by regulation meme always fails to mention the other side-the number of people that have already died because of bureaucratic inefficiency / process / refusal to accept other western countries testing of drugs, that has kept those drugs out of the hands of Americans.Report

            • Avatar Oscar Gordon in reply to Damon says:

              To be fair, Europe had approved Thalidomide ahead of the US.

              Now the FDA could evaluate other countries drug approval process, and if they are sufficient, offer a streamlined approval process so a company is not repeating effort in multiple markets with just a different set of ‘i’s dotted & ‘t’s crossed.Report

              • Avatar Damon in reply to Oscar Gordon says:

                Indeed. But they can’t seem to do that can they? Bureaucratic road block or something else?Report

              • Avatar Oscar Gordon in reply to Damon says:

                Iron LawReport

              • Avatar Mo in reply to Damon says:

                Some of it is featherbedding to make sure they have jobs and some of it is just being unique for the sake of being unique. Is there any good reason why a car that is street legal in Germany isn’t street legal in Texas? Is there a good reason why a practicing doctor or dentist in New York can’t start practicing immediately in California?Report

              • Avatar LeeEsq in reply to Mo says:

                Car sizes do not necessarily always correspond with road widths. Many American cars would be too big for a lot of Japanese roads and highways and would not fit in the lanes.Report

              • Avatar Kazzy in reply to Damon says:

                Perhaps we need multiple approval tracks…

                A drug that stops late stage cancer in its track has a very different risk/reward calculus than a drug that helps with seasonal allergies.

                At the risk of mansplaining, a drug aimed at morning sickness seems to have a relatively low ceiling for reward and a relatively high ceiling for risk. We should be fairly cautious with such drugs. To @damon ‘s point, I doubt anyone died because they didn’t have this drug available to them.

                But that’s not true for all drugs and therefore treating all drugs identically feels wrong.Report

      • Avatar Mike Schilling in reply to Dave says:

        That’s because you guys aren’t real libertarians like Milton Friedman and John Stossel.Report

      • Avatar Murali in reply to Dave says:

        In principle, these regulations are on the paternalistic end of the spectrum. I’m part of a bioethics project where I analyse different accounts of autonomy in clinical and research settings. Some of these things which would seem like easy places to compromise one’s libertarianism turn out to have surprisingly strong arguments against regulation (or for that matter medical licensing)Report

    • Avatar Morat20 in reply to Murali says:

      Oh, I wouldn’t say that. The Pure Food and Drug Act and the FDA is not the no-brainer you seem to think it is among libertarians.

      I’ve met more than my fair share who feel that, indeed, the free market would sort that out so much better than petty government bureaucrats and burdensome regulation that plagues the system now.Report

      • Avatar LeeEsq in reply to Morat20 says:

        I like how they keep dodging or attempting to dodge the fact that the market was flooded with snake oil and adulterated food when it was not regulated. Bakers would add chalk to their bread to make it whiter and butchers used to have all sorts of techniques for making rotten or bad meat look fresh. People couldn’t trust the market to provide unadulterated food because nearly every food supplier found it in his interest to cheat for anybody who wasn’t rich. Most medicine really was nothing more than dolled up alcohol.Report

      • Avatar Oscar Gordon in reply to Morat20 says:

        I’m sure there are efficiencies to be had in the FDA drug approval process, but overall it’s a necessary framework. Medicine/Bio-Chem is exceedingly complex and the information gap between layperson & expert is just too vast a gulf to bridge, with the potential harms too great.

        About the only major change I would make to the scheme as it stands is to better open the experimental options for patients who have exhausted all other options. I know it’s not a simple thing, & not all drug companies want to offer experimental drugs to desperate people, but the FDA should not stand firmly in the way.Report

        • Avatar DavidTC in reply to Oscar Gordon says:

          I’m sure there are efficiencies to be had in the FDA drug approval process, but overall it’s a necessary framework. Medicine/Bio-Chem is exceedingly complex and the information gap between layperson & expert is just too vast a gulf to bridge, with the potential harms too great.

          Yes. I think it’s telling that most of the people we see complaining about the FDA’s drug approval process are obvious scam artists, and the people who *do* have to deal with it, aka, the drug companies, don’t seem to have much of a problem with it, or at least not with the process in general.

          That said, as science turn scrutiny on medicine, it is turning out there’s a *lot* wrong with how drug trials are currently conducted, and how medical research works. A lot of trials are unreplicable, and despite medicine claiming otherwise, we’re just *guessing* with a lot of stuff. But that’s not really the FDA’s fault, nor can they really fix it…medicine itself is going to have to get its act together.

          About the only major change I would make to the scheme as it stands is to better open the experimental options for patients who have exhausted all other options. I know it’s not a simple thing, & not all drug companies want to offer experimental drugs to desperate people, but the FDA should not stand firmly in the way.

          Amen. Not just for the sick people, but because it’s invaluable for actually testing the drugs.

          I’d go a step farther and argue that a lot of the stuff that the FDA has rejected for one reason or another should be available for patients without options. Not the stuff that doesn’t work, obviously, but if there’s some drug that would be a miracle drug except it causes liver failure in 1/4th of the people who take it, obviously it shouldn’t be prescribed to the general public, but there’s no harm in some guy going to die in a few weeks taking it.Report

          • Avatar Oscar Gordon in reply to DavidTC says:

            or at least not with the process in general

            Exactly. I’m sure there are things that could be done better, and we would hope the FDA would maintain an active interest in identifying such things and implementing them (although I suspect the Iron Law gets into the way of that more often than not).

            The issues with studies & reproducibility is an issue, but it’s not one I have seen any good ideas about.

            but because it’s invaluable for actually testing the drugs.

            Yes & no. Sometimes it’s helpful, sometimes it’s too much of an uncontrolled / uncontrollable to offer much in the way of useful data.

            shouldn’t be prescribed to the general public, but there’s no harm in some guy going to die in a few weeks taking it.

            Here the only problem is that in most cases, the cost/effort required to make the drug will far exceed what a drug maker is willing to put forward for one-off cases. I recently read that a drug was approved to be made via 3D-printing. If it was possible to “print” a drug such that it could be done affordably on a small scale, but the demand was so low that creating a manufacturing line for it was not worth the cost, I could see boutique drug makers popping-up to fill that gap. Then the only issue is one of IP (GSK might have a moderately dangerous miracle drug, but they would need an incentive to license or release the IP so a boutique maker could actually make it).Report

          • Avatar DensityDuck in reply to DavidTC says:

            “I think it’s telling that most of the people we see complaining about the FDA’s drug approval process are obvious scam artists, and the people who *do* have to deal with it, aka, the drug companies, don’t seem to have much of a problem with it, or at least not with the process in general.”

            Uh, what?

            The priority review process does not exist because of complaints by obvious scam artists and snake-oil merchants. In fact, it was put together precisely because drug companies had problems with the review process–to the point where they didn’t even want to start it, because finishing it would cost more than they’d make from the drug they got.

            “a lot of the stuff that the FDA has rejected for one reason or another should be available for patients without options. ”

            See, that’s the thing–if you think that FDA rejection shouldn’t result in denial, then why should there be an FDA “approve/reject” activity? Why shouldn’t the FDA just define minimum standards of toxicity and quality, and then let consumers make their own decisions? To steal someone else’s line, if someone wants to sell snake oil then the FDA’s only input should be to ensure that the bottles do indeed contain oil squeezed from snakes and that all possible side effects of drinking snake oil are listed on the package.Report

            • Avatar DensityDuck in reply to DensityDuck says:

              Incidentally, that latter bit is getting closer every day.Report

            • Avatar Oscar Gordon in reply to DensityDuck says:

              I’d be more open to that last bit if we didn’t have knuckleheads like the Food Babe out there claiming everything is a poison, etc, & not getting rhetorically beaten like a cheap pinata by anyone & everyone with a scintilla of sense.Report

              • Avatar Stillwater in reply to Oscar Gordon says:

                Food Babe out there claiming everything is a poison, etc, & not getting rhetorically beaten like a cheap pinata by anyone & everyone with a scintilla of sense.

                Who is she? Does she have a TV show or does she write? Maybe documentaries? What’s her viewership? How many people are influenced by her? Stipulate a threshold baseline we can agree on and I’m in. I’ll start pounding on her mercilessly.

                I’m only sorta joking, actually. I mean, I’ve never heard of her so I have a hard time believing she’s setting our Cultcha on a radically different trajectory than it’s everalways been on.

                I’m certainly open to learning more.Report

              • Avatar Oscar Gordon in reply to Stillwater says:

                Apologies for linking to Gawker

                Likewise the likes of Mercola, or any other number of outfits that confusing dosing & compounding with toxins & poisons, or anti-vacc people, etc. ad nauseum.Report

              • Avatar greginak in reply to Oscar Gordon says:

                It may be Gawker but that was a great piece on the food chick. The Gawkerverse has some very good nuggets mixed in with all their other crap.Report

              • Avatar Stillwater in reply to Oscar Gordon says:

                Hmmm. So the writer of the linked article busts her on the claim that there is no safe level of ingesting chemicals by citing that water is a chemical? (Really? A smart guy did this? (Which reminds me of my theory of people who identify as “smart guys”. I’ll have to tell you about it sometime.))

                And then he says – if I’m remembering it right – that ingesting high quantities of sugar doesn’t negatively effect an individual’s biochem. (Did I read that right? It’s a chemical afterall, so….)

                I don’t know, Oscar. There’s a lot of bullshit libertarians say that I let slide. I don’t know why I ought to single out the Food Babe for receiving The Wrath of (My) Common Sensicality. I only have so much to spare after I take my fair share.Report

              • Avatar Oscar Gordon in reply to Stillwater says:

                @stillwater

                Are you just grousing because the author’s snark is off-putting, or do you honestly want me to expand on things? And I’m not being curt, I just don’t want to write out a long explanation that isn’t really wanted or needed.Report

              • Avatar Stillwater in reply to Oscar Gordon says:

                No, I don’t want you to expand on things. I found the “smart guy” tone of the writer you linked to more insulting and damaging to my common sense than anything he referred to the food babe doing.

                I mean, I now know she banned 6000 commenters from her Facebook page but why should a give a rat’s ass about any of that.

                For my part, and take this for what it’s worth and criticize me profusely accordingly, I’m more concerned with countering the damage done by ambitious egocentric and incredibly ignorant “smart guys” than I am a person who has a readership catering to views those folks probably already hold.Report

            • Avatar greginak in reply to DensityDuck says:

              I for one have the ability to do many double blind controlled studies with a large N. It’s one of my nerdy hobbies. So if all the FDA did was monitor for toxicity it certainly wouldn’t affect me. Of course the various drug companies do them and should never be doubted.Report

        • Avatar Murali in reply to Oscar Gordon says:

          This is the thing I’m working on. I should be done by mid September. I’ll see if I can write up a post about this once I’ve got all the arguments in and I can decide which way to go with this.Report

  2. Avatar LWA says:

    The mere fact that people who are otherwise intelligent, feel comfortable speaking about “regulation” as a singular entity, with a single cause and effect is, to me, remarkable.

    It always reminds me of that scene in Amadeus where Jeffrey Jones as an ignorant noble, says the composition has “too many notes”, to which Mozart asks, “which notes, exactly?” and Jones replies with a dismissive wave of his hand, “Oh I don’t know, just take some out.”

    Because all notes, like all regulations, are interchangeable.

    I also can’t help but notice though, that when people voice opposition to “regulation” it is invariably selfserving.

    You will never hear a tech company propose eliminating copywrite regulations for example or a bank suggest we eliminate the county record of property maps and just let people work out amongst themselves where property divisions lie.

    Because in our political parlance, laws that define and protect property holders are not defined as “regulation”- only laws that protect the interest of nonproperty holders get that title.Report

  3. Avatar Kazzy says:

    Look, if babies want to be born without arms and legs, who are you to get in their way? Statist.

    Also, you’re being limbist, acting like having more limbs is better than having fewer limbs.

    I think that about covers it…Report

  4. Avatar Kolohe says:

    Do a hip hip hooray for the EPA next.Report

  5. Some of the discussion above about the implications of Mr. Kelsey’s wise decision not to permit Thalidomide in the US for whether regulation is a good or a bad thing places too high a stake on Mr. Kelsey’s decision. If for whatever reason he had been on the wrong side, and permitted the drug instead of opposing its entry to the US, then anti-regulation types would have taken that as evidence that regulation is bad, or doesn’t do what it supposedly does best.

    Other than the OP, I know nothing of Mr. Kelsey. But I certainly wouldn’t want to say anything against him. He apparently made the right call while under pressure to make the wrong (or at least a hasty) call.Report

  6. Avatar Brandon Berg says:

    Of course, this cuts both ways. If drugs save lives, then it’s undeniable that long approval processes kill. Maybe not on net, but that’s not a question that can be settled by appeal to that one time it worked out pretty well.

    In this particular case it was the right call, but it’s not at all obvious that automatically approving drugs approved for use in select foreign countries is a bad policy.Report

    • Avatar Stillwater in reply to Brandon Berg says:

      If drugs save lives, then it’s undeniable that long approval processes kill.

      Only if it’s demonstrated that those drugs actually save lives, yes?

      I’m not sure what it is with libertarians and the reliance on counterfactually-based, epistemically confused, historically-revisionist thinking, but it’s effing weird.Report

      • That’s not fair to Brandon’s point. Some drugs do save lives, but in order to find out if the drug on offer really does save lives (and has “acceptable” side effects), those particular drugs’ availability is delayed as the regulators go through the approval process. In the meantime, people whom those drugs could save don’t have access to them. The trick, as I see Brandon saying it, is not to abandon regulation altogether, but to try to make sure the process closes the gap between drug creation and drug availability while weeding out all the harmful ones. The process is always going to be imperfect, which is not by itself an argument against having a process, but a warning that there are tradeoffs.Report

    • Avatar Notme in reply to Brandon Berg says:

      Didnt we see that when aids activists were telling the fda they needed to fast track drugs lest more people die?Report

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