Sometimes It Takes a Crisis

 

Sometimes it takes a crisis to make a problem obvious. In this case, the COVID-19 testing debacle has made it clear that we have a serious problem with regulatory agencies. Specifically, we’ve allowed those agencies to think that they are in charge of the area that they regulate.

For those who missed it, the New York Times had a very illuminating article last week about the reasons why the US has seen significant delays in testing for the COVID-19 virus. The short version is that the CDC and FDA were the cause of the problem. Existing regulations prevented tests from being developed outside of CDC-approved research labs and without FDA approvals. Regulators refused to allow any exceptions to these regulations, even when it was clear that community transmission of the virus was occurring and we needed to drastically increase the scale of our testing. By the time that the exceptions were finally allowed, the CDC developed test had been shown to be deficient and precious weeks had been lost in the battle against the virus.

The CDC and FDA regulations were created with the best of intentions, and one can argue that under normal circumstances they were not only beneficial but necessary. That the only problem was the failure of the bureaucrats to concede ground in their ongoing turf wars and waive requirements in the face of an emergency. One can argue that, but one would be wrong. Even if it were true that the current regulations work fine in ordinary times and only become overly burdensome in an emergency (it’s not), the delay that inevitably occurs when there is an emergency is reason enough to change the model. We should use the same rules both in and out of emergencies. However beneficial the FDA and CDC (and every other regulatory agency) might be, and however pure their intentions, they base their regulations on the presumption that they are in control of the area they regulate. We need to change that.

Regulatory agencies often require that everyone involved in an activity obtain their approval before proceeding. In this case, labs couldn’t do COVID-19 testing until they proved to the FDA that their test was valid. But that’s exactly backward of how it should work. The burden shouldn’t be on the labs to prove to the FDA that their tests work, the burden should be on the FDA to prove that a lab’s tests don’t work. Labs are free to start testing as soon as they can roll out a valid test. The FDA can then focus their efforts on preventing frauds and charlatans from taking advantage of the crisis instead of wasting time on checking over (and therefore delaying) perfectly good tests.

This is the paradigm that should be used across all regulatory agencies. The government doesn’t rule over every area it regulates. Agencies aren’t the ultimate authority. All they should do is make sure everyone is playing by the same rules. I can already hear the good government types screaming about anarchy and the wild west. That’s not what I’m advocating. Let the agencies establish some minimum standards that have to be met and consequences for fraud. But the burden still has to be on the agencies to prove that the standards aren’t met. Everyone is free to participate in a market, and the agencies can prosecute those who fail to meet minimum standards.

We have surrendered too much of our freedom to the government. The ongoing crisis should show us the dangers of that and guide us in restoring our liberty. This is not some hypothetical scenario or libertarian fantasy about the damage of over-regulation. This is the real world and real people are going to die because the CDC and FDA regulations prevented us from clearly seeing the dangers of this virus. Too many people, both in and out of government, doubted the severity of the situation and refused to take action until it was too late to save those lives. We need to act now to reform our bureaucracy and return control of our lives to where it belongs – in our own hands.

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  1. cirby Inactive
    cirby
    @cirby

    A month ago, the narrative was “Trump is getting in the way of the CDC, he should get out of the way.”

    Now, the narrative is “Trump should have overridden the CDC.”

     

    • #1
  2. Ralphie Inactive
    Ralphie
    @Ralphie

    It is amazing when there is a crisis, the government that reconizes they get in the way is the most level headed. In hurricanes, citizens that step up voluntarily are critical to recovery. We are generous and caring people. Clarence Thomas gave Hillsdale’s address a few years ago, and it was a main focus. He related how neighbors helped get a crop in, and that that spirit needs to be encouraged today.

    • #2
  3. Dr. Bastiat Member
    Dr. Bastiat
    @drbastiat

    Absolutely true.

    • #3
  4. MarciN Member
    MarciN
    @MarciN

    I think this crisis will push us through and into a new infectious disease prevention system. We’ve been lucky with Ebola and Zika and H1N1 so far. Even though they strained our existing systems, we succeeding in keeping them at bay, but just barely.

    We need to launch a coordinated, informed, well-thought-out global attack on infectious diseases.

    Any thinking person looking at the infectious disease controls that resulted in the creation of the Ellis Island facility has been looking at this century’s unlimited casual tourist, business, and student travel around the world with some fear and trepidation. It was only a matter of time.

    We need new disease detection systems and procedures across the board. This crisis will be the impetus to find them to make the world safe for travel. We can and we will succeed.

    [continued in comment 5]

    • #4
  5. MarciN Member
    MarciN
    @MarciN
    • #5
  6. James Gawron Inactive
    James Gawron
    @JamesGawron

    Nick H: The burden shouldn’t be on the labs to prove to the FDA that their tests work, the burden should be on the FDA to prove that a lab’s tests don’t work.

    Nick,

    As much as I agree that bureaucracy is killing us, I think this statement is wrong. I think what’s really going wrong in this society is what cirby said:

    A month ago, the narrative was “Trump is getting in the way of the CDC, he should get out of the way.”

    Now, the narrative is “Trump should have overridden the CDC.”

    The news media from the local ones all the way up the most sophisticated is hyper-politicized. They are so interested in “producing” the political effect that they want, actually being objective in reporting the news has turned into a joke. If there wasn’t so much static from the near-psychotic news media, I think the common-sense need to fast track would have come forward at CDC. However, the media would rather peddle disaster and who to blame for it than getting with the program and find the solution to the problem.

    Also, let’s not forget that while this thing was brewing one of the two major political parties chose to plunge us into the spastic merry-go-round of a phony impeachment. The Administration and much of the country was forced to concentrate on this idiot political circus instead of what was happening in China. With this level of irresponsibility in the media and half of the government, it’s little wonder that CDC starts to act like it’s regulations are all that matters and everyone else is crazy when so many commentators are crazy.

    Regards,

    Jim

     

    • #6
  7. Nick H Coolidge
    Nick H
    @NickH

    James Gawron (View Comment):
    As much as I agree that bureaucracy is killing us, I think this statement is wrong. I think what’s really going wrong in this society is what cirby said

    I don’t see any contradiction between what cirby said and what I wrote. Both can be true simultaneously that the media is behaving irresponsibly and that regulators shouldn’t be regulating as if they are the ultimate authority in their area. Both are also going to be extremely difficult problems to solve, but we would benefit greatly from doing so.

    • #7
  8. Jerry Giordano (Arizona Patrio… Member
    Jerry Giordano (Arizona Patrio…
    @ArizonaPatriot

    I do not agree with the OP.

    The CDC error in making and distributing WuFlu test kits could have occurred in a private lab.  It was very bad that it occurred in the only lab making the test.  But if this task had been out-sourced to 10 or 20 private labs, with no requirement of pre-approval, we would not have known which tests were reliable, and which were not.

    As I understand the CDC error, the problem was false positives.  This is bad, but not as bad as a flawed test that would result in false negatives.

    I do think that some heads should roll at CDC, figuratively speaking of course, among those responsible for the test kit error.  I rather doubt that this will happen, but I am more optimistic about it than I would be with any other President.

    • #8
  9. James Gawron Inactive
    James Gawron
    @JamesGawron

    Nick H (View Comment):

    James Gawron (View Comment):
    As much as I agree that bureaucracy is killing us, I think this statement is wrong. I think what’s really going wrong in this society is what cirby said

    I don’t see any contradiction between what cirby said and what I wrote. Both can be true simultaneously that the media is behaving irresponsibly and that regulators shouldn’t be regulating as if they are the ultimate authority in their area. Both are also going to be extremely difficult problems to solve, but we would benefit greatly from doing so.

    Nick,

    Trump’s the guy to do this. He will cut through the cr*p. The other side is so full of cr*p that they’ll only make it worse.

    Regards,

    Jim

    • #9
  10. Roderic Coolidge
    Roderic
    @rhfabian

    I’m in general all in favor of deregulation, but doing away with prior approval comes with some risk.

    A lot of the basis of the FDA’s legitimacy comes from the case of thalidomide babies, horribly deformed children born without appendages that resulted from mothers using thalidomide to treat the nausea of pregnancy in Europe and Canada. Ten thousand deformed babies were born.   A single FDA bureaucrat-physician, Frances Oldham, stood in the way of approval of thalidomide in the US demanding that more testing of the drug be done and thereby avoided that for American children.

    By the same token, a test for COVID-19 that has a lot of false negatives could be a total disaster if it is released on the market in a big way and the FDA is relegated to playing catch up. 

    • #10
  11. James Gawron Inactive
    James Gawron
    @JamesGawron

    Roderic (View Comment):

    I’m in general all in favor of deregulation, but doing away with prior approval comes with some risk.

    A lot of the basis of the FDA’s legitimacy comes from the case of thalidomide babies, horribly deformed children born without appendages that resulted from mothers using thalidomide to treat the nausea of pregnancy in Europe and Canada. Ten thousand deformed babies were born. A single FDA bureaucrat-physician, Frances Oldham, stood in the way of approval of thalidomide in the US demanding that more testing of the drug be done and thereby avoided that for American children.

    By the same token, a test for COVID-19 that has a lot of false negatives could be a total disaster if it is released on the market in a big way and the FDA is relegated to playing catch up.

    Roderic,

    BTW, almost all the quick & cheap screening tests coming out will be generating lots of false positives. This is normal for an inexpensive easy to administer screening test. What is also normal is not to alarm any of the people who test positive but to tell them their test was inconclusive and to come in for another test but to self-quarantine just in case. Then they will be given the full lab test which has complete specificity (no false positives or negatives). The test is much more expensive and requires a lot more expertise but you’ve already ruled out a huge number of cases and narrowed it down to just these likely suspects.

    I am very afraid that in the current corona panic mode that we are in, the false positives from the screening tests will get reported as infections.

    Regards,

    Jim

    • #11
  12. Nick H Coolidge
    Nick H
    @NickH

    Roderic (View Comment):

    I’m in general all in favor of deregulation, but doing away with prior approval comes with some risk.

    A lot of the basis of the FDA’s legitimacy comes from the case of thalidomide babies, horribly deformed children born without appendages that resulted from mothers using thalidomide to treat the nausea of pregnancy in Europe and Canada. Ten thousand deformed babies were born. A single FDA bureaucrat-physician, Frances Oldham, stood in the way of approval of thalidomide in the US demanding that more testing of the drug be done and thereby avoided that for American children.

    By the same token, a test for COVID-19 that has a lot of false negatives could be a total disaster if it is released on the market in a big way and the FDA is relegated to playing catch up.

    Prior approval of medication is very different from the prior approval regulations for testing described in the article. We can all agree that the FDA should have enough authority to prevent another thalidomide. But if it takes on too much authority it inhibits the development of new medications to an unreasonable degree. The challenge is finding how much authority is enough, and then limiting it to that. 

    As for the tests, it would indeed be a disaster if such a test were released in a big way, and it was the only test available. One problem with having the government as the only gatekeeper for the tests is that it inhibits competition. The best way to mitigate the effects of bad tests is to have more than one test available. Better to let a bad test get out on the market with other tests available to replace it than have a bad test make it past the gatekeeper when there are no other tests available (which is exactly what happened).

    • #12
  13. Jon1979 Inactive
    Jon1979
    @Jon1979

    It’s the safety-vs.-freedom issue, where government is on the side of enacting rules to keep people ‘safe’. Under non-emergency situations, reports of some negative condition that is the result of the freedom to produce things is spotlighted, and the inevitable reaction is that if something when wrong, let’s give government the power to regulate it so it doesn’t happen again.

    Over time, that leads to a tightening down of what’s allowed similar to the analogy about the frog in the slowly-heating up pot of water. You don’t notice the changes, or the lack of ability to do things that were permissible before, because the changes are done gradually. It’s only when a sudden crisis hits that the freedom to quickly react runs into all the safety regulations government has put in, and angers enough of the public who want something done now.

    You see that often with infrastructure reconstruction in the wake of a catastrophe. Rule put in for safety concerns which have also serve to slow down the construction or development of new things to a glacial pace are accepted by enough of the public in normal times. But when a crisis hits, the politicians are faced with the option of sticking by their government regulations and risk blow-back at the ballot box, or toss the rules out at least temporarily in order to have the freedom react as fast as possible. The latter always wins out, but because enough people don’t continue to pressure their pols, the glacial status quo returns, and safety again trumps freedom once the crisis is over.

    • #13
  14. Columbo Inactive
    Columbo
    @Columbo

    When the CDC/FDA is run like the DMV, we’re SOL.

    • #14
  15. I Walton Member
    I Walton
    @IWalton

    The central governments is  the biggest problem.   Big state governments  the next and so on until we get to individuals who are quite capable of solving their own problems, or work them out with others who suffer the other side of the problem,  or occasionally not.   That’s why clear law is essential and why bureaucratic pretended law is a real and growing problem.  Governments use minor and not so minor problems to expand bureaucratic law that essentially removes control from individuals.  Governments can gather and spread information, they don’t create it, those sources are nearly infinite and they enjoy nearly infinite economies of scale.  It’s  good to have general protocols, not quite laws rather useful rules responsible people can follow locally, and even  occasionally laws that cover larger populations and political entities.    We’ve been taught that governments are primary problem solvers.  It should be obvious they are not.   What’s going on with this new disease isn’t anybodies fault, but it should be teaching us something about how not to manage matters, why concentrated power isn’t good except for war at least if someone else’s government starts it.  Maybe that’s why big government types like to call things the war against what ever.  It isn’t and when it is it should be obvious.   We’ve been lectured  so much over the last century about how important government is, we’ve come to believe it.  (Two world wars when it actually is helped that along.) Good clear simple law and an ability to enforce it is essential but  it’s nonsense to think governments can run matters, that bureaucrats are essential and that they can institute the laws we need. The more complex and giant an economy and society the less useful centralized governance can be, but we’ve come to believe just the opposite.   

    • #15
  16. MichaelKennedy Inactive
    MichaelKennedy
    @MichaelKennedy

    I agree that the FDA has been obsessed with the Thalidomide case.  It has inhibited much development of new drugs, one of which may be remdesivir, the drug that may cure the advanced cases of COVID 19. The CDC has been obsessed with a bunch of PC topics like bullying,  guns and obesity.  There is a joke from Dilbert that engineers love to solve problems and, if there are no problems available, they will create them.  The CDC botched the Anthrax crisis in 2001 and  never solved it.  They have been too political since well before that failure.

    NASA is another government bureaucracy that has grown immobile. For similar reasons.

    • #16
  17. Columbo Inactive
    Columbo
    @Columbo

    MichaelKennedy (View Comment):

    I agree that the FDA has been obsessed with the Thalidomide case. It has inhibited much development of new drugs, one of which may be remdesivir, the drug that may cure the advanced cases of COVID 19. The CDC has been obsessed with a bunch of PC topics like bullying, guns and obesity. There is a joke from Dilbert that engineers love to solve problems and, if there are no problems available, they will create them. The CDC botched the Anthrax crisis in 2001 and never solved it. They have been too political since well before that failure.

    NASA is another government bureaucracy that has grown immobile. For similar reasons.

    Thank you 0bama.

    • #17
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