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.

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  1. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    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?

    • #1
  2. Nicegrizzly Inactive
    Nicegrizzly
    @Nicegrizzly

    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. 

    • #2
  3. RushBabe49 Thatcher
    RushBabe49
    @RushBabe49

    I would love to participate in the vaccine trial taking place at the U of Washington.  But trial participants must be between the ages of 25 and 54.  I am 70, which puts me in the highest-risk group for the disease.

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

    RushBabe49 (View Comment):

    I would love to participate in the vaccine trial taking place at the U of Washington. But trial participants must be between the ages of 25 and 54. I am 70, which puts me in the highest-risk group for the disease.

    First I’ve heard about a human trial anywhere. I’m very glad it’s at least happening.

    Any link or more information?

    • #4
  5. The Reticulator Member
    The Reticulator
    @TheReticulator

    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.

    • #5
  6. Nicegrizzly Inactive
    Nicegrizzly
    @Nicegrizzly

    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.

    • #6
  7. The Reticulator Member
    The Reticulator
    @TheReticulator

    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? 

    • #7
  8. J Climacus Member
    J Climacus
    @JClimacus

    iWe:

    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.

    Death by bureaucracy. If this thing really gets out of hand, there might be enough public pressure to expedite the process. At least I hope. It’s one thing if the occasional person dies because he can’t get access to an experimental cancer treatment. That’s not broad enough to generate significant political pressure. But if people across the country are seeing their parents and grandparents succumb to this disease, a groundswell of public sentiment might force a change.

     

    • #8
  9. Stad Coolidge
    Stad
    @Stad

    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?

    I thought the Trump administration relaxed the rules on this . . .

    • #9
  10. Stad Coolidge
    Stad
    @Stad

    RushBabe49 (View Comment):

    I would love to participate in the vaccine trial taking place at the U of Washington. But trial participants must be between the ages of 25 and 54. I am 70, which puts me in the highest-risk group for the disease.

    Wait a minute . . . aren’t we always told the higher risk population need vaccines the most?

    • #10
  11. Saint Augustine Member
    Saint Augustine
    @SaintAugustine

    Stad (View Comment):

    RushBabe49 (View Comment):

    I would love to participate in the vaccine trial taking place at the U of Washington. But trial participants must be between the ages of 25 and 54. I am 70, which puts me in the highest-risk group for the disease.

    Wait a minute . . . aren’t we always told the higher risk population need vaccines the most?

    After they’re approved.  Approval has high standards for testing.  There are good reasons to have rules like this.

    But it’s possible to have too many rules, too few exceptions, etc.  Particularly when, as iWe lays out very well, the rule is meant to protect the person testing the medical treatment and the rule ends up preventing him from what might save his life.  A right to try when you’re at death’s door is a good thing.

    • #11
  12. Kozak Member
    Kozak
    @Kozak

    So a vaccine was developed for SARS.  Similar virus. to Covid 19.   Test animals developed good antibody levels.

    However when re exposed to the virus, the test animals developed a hyper immune response with cytokine storm.

    Lots of them died.  Thats one of the reasons no SARS vaccine after 15 years.

    Developing a vaccine is not easy.

    • #12
  13. Stad Coolidge
    Stad
    @Stad

    Saint Augustine (View Comment):
    After they’re approved. Approval has high standards for testing. There are good reasons to have rules like this.

    Ah, you’re right.  Still, if this is truly a crisis as the MSM says it is, shouldn’t the rules be relaxed in this case?

    • #13
  14. iWe Coolidge
    iWe
    @iWe

    Stad (View Comment):

    Saint Augustine (View Comment):
    After they’re approved. Approval has high standards for testing. There are good reasons to have rules like this.

    Ah, you’re right. Still, if this is truly a crisis as the MSM says it is, shouldn’t the rules be relaxed in this case?

    Rules should all be eliminated if people are willing to take the risks on their own heads.

    • #14
  15. The Reticulator Member
    The Reticulator
    @TheReticulator

    Kozak (View Comment):

    So a vaccine was developed for SARS. Similar virus. to Covid 19. Test animals developed good antibody levels.

    However when re exposed to the virus, the test animals developed a hyper immune response with cytokine storm.

    Lots of them died. Thats one of the reasons no SARS vaccine after 15 years.

    Developing a vaccine is not easy.

    Interesting. I’m curious about what animals are used for testing virus vaccines like this?  Does it have anything to do with the animal populations that originated some of the viruses that came to infect humans?

    • #15
  16. The Reticulator Member
    The Reticulator
    @TheReticulator

    iWe (View Comment):

    Stad (View Comment):

    Saint Augustine (View Comment):
    After they’re approved. Approval has high standards for testing. There are good reasons to have rules like this.

    Ah, you’re right. Still, if this is truly a crisis as the MSM says it is, shouldn’t the rules be relaxed in this case?

    Rules should all be eliminated if people are willing to take the risks on their own heads.

    In general I agree, but let’s put this to a further test. Should parents be allowed to take the risk with their children?  What about legal guardians? 

    • #16
  17. iWe Coolidge
    iWe
    @iWe

    The Reticulator (View Comment):

    Rules should all be eliminated if people are willing to take the risks on their own heads.

    In general I agree, but let’s put this to a further test. Should parents be allowed to take the risk with their children? What about legal guardians? 

    Fortunately for Corona, this is not an issue – kids are fine. But for those of us caring for older parents who might not be able to make these decisions already – why not? After all, we allow medical decision-makers to pick DNR, sometimes even assisted suicide. Why not allow freedom to try to live?

    • #17
  18. The Reticulator Member
    The Reticulator
    @TheReticulator

    iWe (View Comment):

    The Reticulator (View Comment):

    Rules should all be eliminated if people are willing to take the risks on their own heads.

    In general I agree, but let’s put this to a further test. Should parents be allowed to take the risk with their children? What about legal guardians?

    Fortunately for Corona, this is not an issue – kids are fine. But for those of us caring for older parents who might not be able to make these decisions already – why not? After all, we allow medical decision-makers to pick DNR, sometimes even assisted suicide. Why not allow freedom to try to live?

    Yes, in this case it’s not an issue. 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.

    • #18
  19. Unsk Member
    Unsk
    @Unsk

    First the FDA and CDC hindered the release of test kits; now apparently there is a shortage of reagents to do the actual testing. These agencies have become worse than worthless; they are threat to the general welfare and emergency powers need to be put in place to oversee their every move. 

    I am not so worried about vaccines. Vaccines in the near future won’t be of a great help and it is doubtful that a vaccine would work against a disease that mutates as fast as the  Covel-19.

    That said treatment options need to be ramped up muy pronto and we cannot  let the FDA and CDC get in the way again. People’s lives are at stake.  I happen to think many more people than are currently thought in the US have already been exposed and that the vast majority have been able to deal with it. However  those with lung issues may be at serious risk; there is a  fibrous  condition  in the lungs that is associated with the disease and it may  be a serious long term health hazard that can’t so far be cured and that be make recovery much more difficult. 

    I also think  we need to be building separate specialized hospital facilities before our  health care facilities are overwhelmed. 

    • #19
  20. iWe Coolidge
    iWe
    @iWe

    As I posted in the Member Feed:

    Recent information from China suggested that drugs for Rheumatoid Arthritis worked a treat on the virus. People on death’s door got up and walked away a few days later. China’s willing to experiment on people. The theory was that the primary danger isn’t the virus, but the response. [Supporting data here. and here. and here.]

    But our regulations get in the way. Off-label use for existing drugs should be the fastest and easiest thing to do, since doctors already do it regularly.

    • #20
  21. Douglas Pratt Coolidge
    Douglas Pratt
    @DouglasPratt

    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.

    • #21
  22. Ontheleftcoast Inactive
    Ontheleftcoast
    @Ontheleftcoast

    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.

    • #22
  23. Ontheleftcoast Inactive
    Ontheleftcoast
    @Ontheleftcoast

    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.

    • #23
  24. Ontheleftcoast Inactive
    Ontheleftcoast
    @Ontheleftcoast

    iWe (View Comment):

    Stad (View Comment):

    Saint Augustine (View Comment):
    After they’re approved. Approval has high standards for testing. There are good reasons to have rules like this.

    Ah, you’re right. Still, if this is truly a crisis as the MSM says it is, shouldn’t the rules be relaxed in this case?

    Rules should all be eliminated if people are willing to take the risks on their own heads.

    Does “taking the risk” include “accepting the costs of future care if taking the risk results in adverse but not lethal effects?”

    • #24
  25. JamesSalerno Inactive
    JamesSalerno
    @JamesSalerno

    Milton Friedman always made a great argument about this. We already have tort laws in place in the event that a product is harmful. The amount of lives saved by a drug after it is regulated does not make up for the amount of lives lost by holding back the drug in bureaucratic red tape.

    • #25
  26. Aaron Miller Inactive
    Aaron Miller
    @AaronMiller

    I’m against all consumer protection regulations except as advisory standards, ala Consumer Reports and the Better Business Bureau. But I wonder what public health protections are necessary to prevent medical experimentation from leaking contagious diseases.

    • #26
  27. iWe Coolidge
    iWe
    @iWe

    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.

    • #27
  28. iWe Coolidge
    iWe
    @iWe

    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.

    That is why people and their heirs needs to be able to sign away their legal rights in order to take that risk.

    • #28
  29. The Reticulator Member
    The Reticulator
    @TheReticulator

    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?  

    • #29
  30. John Stanley Coolidge
    John Stanley
    @JohnStanley

    Kozak (View Comment):

    So a vaccine was developed for SARS. Similar virus. to Covid 19. Test animals developed good antibody levels.

    However when re exposed to the virus, the test animals developed a hyper immune response with cytokine storm.

    Lots of them died. Thats one of the reasons no SARS vaccine after 15 years.

    Developing a vaccine is not easy.

    Is that not the same chain reaction that made the “Spanish Flu” of 1918-1919 so deadly?   The hyper immune response caused fluid in the lungs, which cause pneumonia to so easily take hold?

    • #30
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