Regulations Kill

 

There are now several vaccines ready to be tested. But thanks to protocols in place with regulators around the world, everyone says nothing can be released for many months, perhaps a year or more. We need, “experts,” say, to first be sure of the side effects and efficacy and all the risk factors. I can tell you the risk factor for an experimental vaccine: death. But death with hope. Coronavirus for an 80+-year-old offers no such hope.

This is, writ large, precisely the problem with regulation. People should be allowed to take their own risks; even (and especially) the risk of the unknown. If I was older and facing a decent chance of death from this virus, I would cheerfully roll the dice and take an experimental vaccine. Just as I believe that people should be free to make their own decisions in every walk of life.

Government regulations kill. The U.S. government should allow people to sign away their legal rights and take a Corona vaccine (or any other drug or treatment) if they choose to do so. Trump could use this crisis as an opportunity to massively expand freedom for all Americans, saving many lives worldwide in the process.

Published in General
This post was promoted to the Main Feed by a Ricochet Editor at the recommendation of Ricochet members. Like this post? Want to comment? Join Ricochet’s community of conservatives and be part of the conversation. Join Ricochet for Free.

There are 42 comments.

Become a member to join the conversation. Or sign in if you're already a member.
  1. iWe Coolidge
    iWe
    @iWe

    John Stanley (View Comment):
    The hyper immune response caused fluid in the lungs, which cause pneumonia to so easily take hold?

    Which is why immunosuppressants are being trialed for Corona treatment. The Chinese are recommending them.

    But unless you are politically connected, it is quite unlikely that your doctor will prescribe even if you are likely to die without some treatment.

    • #31
  2. iWe Coolidge
    iWe
    @iWe

    The Reticulator (View Comment):

    iWe (View Comment):

    The Reticulator (View Comment):
    But you made a sweeping general statement about rules and regulations in general, so I thought you might be interested in discussing the larger state of affairs than this specific coronavirus disease.

    I would be, generally. But it is a distracting minefield in light of the current crisis.

    Then might I suggest changing the title to something more specific?

    And lose that special click-bait spice? Where’s the fun in that?

    • #32
  3. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Douglas Pratt (View Comment):

    Agreed, but tort reform is part of the picture. No company is going to speedily release a drug if they immediately get sued for it.

    Amen.

    • #33
  4. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Ontheleftcoast (View Comment):

    Saint Augustine (View Comment):

    iWe: This is, writ large, precisely the problem with regulation. People should be allowed to take their own risks – even (and especially) the risk of the unknown.

    Excellent.

    Didn’t we recently have some sort of “right to try” legislation? Does that help any here?

    Right to try is for therapeutics, not vaccines.

    Good to know!

    So what we need here is an extension of Right To Try into new territory.

    • #34
  5. Ontheleftcoast Inactive
    Ontheleftcoast
    @Ontheleftcoast

    Ontheleftcoast (View Comment):

    The Reticulator (View Comment):

    Nicegrizzly (View Comment):

    The Reticulator (View Comment):

    Nicegrizzly (View Comment):
    But I thought they don’t do any safety testing of vaccines?? Or so insist the anti-vaxxers.

    Really? First I ever heard of that one.

    Oh yes, it’s one of their common tropes.

    Hmmm. I probably haven’t paid as much attention as most people, but I thought there were some complaints about the combinations or conditions that weren’t tested, but not that there was no safety testing at all. So what do they think the FDA is doing when it holds up the sale and distribution of vaccines?

    Also that vaccine safety testing detects short term adverse effects but not slow developing ones.

    Repeated injection of foreign proteins is one way to induce autoimmunity in genetically susceptible and possibly non-susceptible animals. Many vaccines include adjuvants designed to augment the immune response to whatever the target organism of the vaccine is. For about two years before the onset of my autoimmune disease, I received weekly aluminum containing bee antigen. 

    Did this cause my illness? We’ll never know. Is there some critical frequency above which it’s more likely that foreign protein injections are more likely to trigger autoimmunity?

    Is a vaccination schedule at which injections containing 16 various foreign proteins – sometimes 8 at the same visit – plus adjuvants are given at birth, 1, 2, 4, 6, 9, 12, and 15 months likely to induce autoimmune disorders? There are at least 80 known autoimmune diseases and many more suspected of being autoimmune. Try sorting out causation for a long list like that. But wait, there’s more.

    A good rule of thumb is that in any disease involving chronic inflammation – which is all chronic diseases – autoimmunity will be a complicating factor.

     

    • #35
  6. Jerry Giordano (Arizona Patrio… Member
    Jerry Giordano (Arizona Patrio…
    @ArizonaPatriot

    Panic seems to lead to unclear thinking.

    Sure, regulations can kill.  Lack of regulation can kill, too.  Kozak’s #12 pointed out the dangers of vaccines (using SARS as an example).

    I’m not specifically experienced in pharmaceutical product liability lawsuits, though I have quite a bit of experience in products liability in general.

    So, iWe, are you proposing that (panicked elderly) people sign some iron-clad waiver for an experimental Wuhan Flu vaccine that might kill them?  For a vaccine to be effective, as I understand it, it must be administered before infection — and no such vaccine is available, and no one knows the risk of infection at this time, and no one knows the fatality rate of the disease.  All of these things must be known, in order to make a rational cost-benefit decision regarding whether to take a vaccine (which might kill you, or be ineffective).

    But you want to leave the decision on whether to take a thus-far hypothetical vaccine — as none has been developed, as far as I know — to individual, panicked senior citizens, who have none of the relevant information?

    From a litigation standpoint, this could be a bonanza for guys like me.  I’m pretty good at trying to litigate through a release.  There are many arguments for setting aside a release, such as failure to disclose the cost-benefit analysis (which no one has the information to perform, at present).  It’s even better when the potential defendant is a pharmaceutical company, which is bound to have much more information than the typical panicked senior citizen.

    Even the pharmaceutical companies generally like the drug approval process — pace, Milton Friedman — because after-the-fact tort litigation presents an enormous risk.  The preemption rules applicable to pharmaceuticals are complicated, but FDA approval provides some level of protection against subsequent litigation risk.

    I do not find the situation to be simple at all.

    • #36
  7. iWe Coolidge
    iWe
    @iWe

    Jerry Giordano (Arizona Patrio… (View Comment):

    Panic seems to lead to unclear thinking.

    I am thinking clearly. I am not panicking.

    Sure, regulations can kill. Lack of regulation can kill, too. Kozak’s #12 pointed out the dangers of vaccines (using SARS as an example).

    Sure. Just as owning a gun leads to more accidental deaths.

    I’m not specifically experienced in pharmaceutical product liability lawsuits, though I have quite a bit of experience in products liability in general.

    So, iWe, are you proposing that (panicked elderly) people sign some iron-clad waiver for an experimental Wuhan Flu vaccine that might kill them?

    People should have the right to decide for themselves what they want to do. That is at the heart of freedom. Yes, mistakes will be made. But there is a reason surgery generally only advanced in time of war: when people have nothing to lose, risks can be taken.

    For a vaccine to be effective, as I understand it, it must be administered before infection — and no such vaccine is available, and no one knows the risk of infection at this time, and no one knows the fatality rate of the disease. All of these things must be known, in order to make a rational cost-benefit decision regarding whether to take a vaccine (which might kill you, or be ineffective).

    NOBODY has perfect information to be sure of any outcome. And even if the odds are 1% or 99%, nobody knows in advance whether they are the majority or the 1%. You do NOT need perfect knowledge to make a rational decision. None of have perfect knowledge. We make decisions all the time, and they are not necessarily bad ones.

    But you want to leave the decision on whether to take a thus-far hypothetical vaccine — as none has been developed, as far as I know — to individual, panicked senior citizens, who have none of the relevant information?

    Nobody does. Note that I am not merely talking of vaccines, but also of drugs (and several have been promising so far). But why deny people the right to try, especially if they are clearly high risk or otherwise nearly-certain to die from the illness???

    From a litigation standpoint, this could be a bonanza for guys like me. I’m pretty good at trying to litigate through a release. There are many arguments for setting aside a release, such as failure to disclose the cost-benefit analysis (which no one has the information to perform, at present). It’s even better when the potential defendant is a pharmaceutical company, which is bound to have much more information than the typical panicked senior citizen.

    A blanket immunity would require fresh legislation and a change in the law.

    Even the pharmaceutical companies generally like the drug approval process — pace, Milton Friedman — because after-the-fact tort litigation presents an enormous risk.

    Sure. Because Pharma companies are about themselves. But as a prospective patient, I care about my health – and more than any researcher or doctor or lawyer or regulator can. I should have the freedom to choose.

    The preemption rules applicable to pharmaceuticals are complicated, but FDA approval provides some level of protection against subsequent litigation risk.

    Yes. But the FDA process kills many people denied medicine. On balance, it is a huge loser.

    I do not find the situation to be simple at all.

    I do. Freedom matters to me. We grant it in so many other ways. Why deny it for advanced medicine?

     

    • #37
  8. Jerry Giordano (Arizona Patrio… Member
    Jerry Giordano (Arizona Patrio…
    @ArizonaPatriot

    iWe, good response.  I do not take such a libertarian approach myself.  Are you advocating this for all medical issues, or just for the WuFlu?

    To answer your last question — “Why deny [freedom] for advanced medicine?” — I think that there is a serious danger.  Charlatans can easily prey on the infirm.

    In an interesting bit of family history, my dad helped stop a cancer quack in the late 1970s or early 1980s.  My dad was an oncologist, and there was a European doctor who was claiming to have a miracle cure, which didn’t work, and was making a great deal of money from desperate cancer patients.  At one point, my dad even wore a wire to gather evidence.

    The quack was named Milan Brych.  There’s actually a Wikipedia entry for him (here), and a movie was made about it (IMDB here), which I have not seen.  He was convicted of multiple crimes (appellate case here).  He was of Czech origin; was kicked out of New Zealand for quackery; then relocated to the Cook Islands.  There’s reportedly a graveyard of his victims in the Cook Islands, nicknamed the “Brych-yard.”  He then moved to the US, was convicted in the early 1980s, and left the country.

    I can’t recall if my dad actually testified in the case.  He died in 2012, so I can’t ask him.  In a somewhat annoying development, it appears that Brych is still alive, though he was older than my dad.

    I haven’t thought about this incident for decades, until prompted by our comments.  It appears that the movie (discussion here) was focused on his time in NZ.  Here’s part of the article:

    On one level this was the story of just another snake-oil salesman. But it offered useful insight into the conditions that allow people to throw reason to the winds. A patient talked about Brych’s “excellent psychological approach. Call it his bedside manner.” To those without hope in an era when cancer treatment was dire, to be treated with dignity by a charlatan was better than nothing. Doctors in training should watch this as a cautionary tale. Brych eventually fled to the Cook Islands, where a cemetery filled with his desperate followers. Yet, to this day, some still believe. The daughter of one of Brych’s patients declared that, if she was in the same position and he was available, she would still put her faith in Brych. Cancerman may be flawed as drama, but as an anatomy of denial, it’s required viewing.

    This is one example about the dangers of an unregulated approach to medicine, and it applies to a number of fields.

    As Thomas Sowell is fond of saying, there are no solutions, only trade-offs.

    • #38
  9. Randy Weivoda Moderator
    Randy Weivoda
    @RandyWeivoda

    Nicegrizzly (View Comment):

    But I thought they don’t do any safety testing of vaccines?? Or so insist the anti-vaxxers.

    I wonder if your above mentioned quandary will cause any cognitive dissonance in this crowd. It should.

    Nicegrizzly!  It’s so nice to have you back!

    • #39
  10. iWe Coolidge
    iWe
    @iWe

    Jerry Giordano (Arizona Patrio… (View Comment):

    iWe, good response. I do not take such a libertarian approach myself. Are you advocating this for all medical issues, or just for the WuFlu?

    All. People should have freedom. And with that comes responsibility for our decisions.

    To answer your last question — “Why deny [freedom] for advanced medicine?” — I think that there is a serious danger. Charlatans can easily prey on the infirm.

    They can. And they do. Now they do it through all the herbal and naturopathic and countless other quackeries. 

    I’d rather encourage certifications by competing “oversight” organizations – customers can decide to rely on one set of experts or another. The FDA would be one of these. The certifications would help inform the customer as to validity, safety, etc. There is no single arbiter, and a competing marketplace of them would serve the public much better.

    This is one example about the dangers of an unregulated approach to medicine, and it applies to a number of fields.

    And charlatans exist in all fields. But independent labs/testers/certs/reviewers can (and do) form a BS-check in other fields. They should be allowed to offer that commercial service in medicine.

     

    As Thomas Sowell is fond of saying, there are no solutions, only trade-offs.

    No argument with this! But right now, the government is the sole gatekeeper. That is not a recipe for innovation and high quality results in any other field. Why do we assume it is good in medicine?

    • #40
  11. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Jerry Giordano (Arizona Patrio… (View Comment):

    To answer your last question — “Why deny [freedom] for advanced medicine?” — I think that there is a serious danger. Charlatans can easily prey on the infirm.

    Where there is charlatanry or fraud, there is not in fact a free choice.

    Regulations to prevent fraud are not, as our friends on the left fancy us to believe, inconsistent with free markets. They protect free markets.

    Your debate with iWe on how much knowledge is necessary for a rational, free medical decision–and on related matters–is super cool. I’m not sure I can find any further opinions on it.

    • #41
  12. Nicegrizzly Inactive
    Nicegrizzly
    @Nicegrizzly

    Randy Weivoda (View Comment):

    Nicegrizzly (View Comment):

    But I thought they don’t do any safety testing of vaccines?? Or so insist the anti-vaxxers.

    I wonder if your above mentioned quandary will cause any cognitive dissonance in this crowd. It should.

    Nicegrizzly! It’s so nice to have you back!

    Hey, thanks!! As a public health nurse, this stuff is my jam. 

    • #42
Become a member to join the conversation. Or sign in if you're already a member.