Tuesday, June 8, 2021

Did The FDA Procedures Cost Thousands of Lives.

It's beginning to look as if what was called a racist Trumpian conspiracy theory that the pandemic virus was "made in China" rather than a natural occurrence is true after all. Even more disturbing is the idea that a panicky close-mouthed Chinese Communist Party clamped down on the true story and let their problem spread worldwide. For months, the U.S. and the WHO public health establishments reassured us that the man-made conjecture couldn't be true, an opinion echoed vigorously by the major media. To say otherwise was grounds for blackballing by the social networking fact finders. There's a strong taint of political ideology mixed up in this whole mess which allowed the devastation of 2020 to be worse than it could have been. But it's not all China's fault. A big part of death and economic destruction in our country may have been our own damn fault.

What do I mean by that? Well, from early January until early March of 2020, it was very unclear what was going on even though in retrospect the virus was spreading exponentially. We were getting mixed overly optimistic messages, not only from the politicians of both parties but also from the public health authorities right down to the man in charge, Dr. Fauci. What was missing during this period was testing, which would have allowed us to realize that most cases had either no or insignificant symptoms but could nevertheless spread the germ and were doing so at a rapid rate. What was the problem with testing? Labs all across the country had been able to come up with accurate tests within a couple of weeks after the genome was worked out in early January. But regulations prohibited their use of the tests without FDA approval. The CDC devised a test for the government which proved to be inaccurate and finally, after much arm twisting, the FDA gave emergency approval for outside testing which then ramped up dramatically through private, hospital and state labs. Through all this we missed out on 2 months of accurate information which. as it turns out could have been lifesaving.

Once we got the real picture it was way too late for the standard public health measures of case finding and contact tracing. It appears now, from comparing the outcomes of the disease in the various states, that lockdowns and arbitrary designations of essential and non-essential commerce for the most part caused more harm than good, and that mandated masking and social distancing have been of limited value. What is now clearly saving the day are the dramatically effective vaccines, finally released in December, once again with the FDA being pushed to expedite their approval process.

But hold on, that's not the whole story. The RNA vaccines of Pfizer and Moderna had been prepared, tested in humans and found to induce neutralizing antibodies with no obvious short term serious toxicity as of July 2020. But to get FDA approval the standard procedure was to require Phase 3 testing in larger numbers of healthy people and that's what was done over the subsequent 6 months. Mind you, however, that we were in the height of a rampant pandemic that was mostly benign but lethal for specific groups which had been identified. Could not the vaccines, which appeared to be effective and safe at least in the short term, have been tried not on healthy people, but on willing nursing home and other chronically ill patients for example, for whom the benefit to risk ratio would have been so dramatically favorable? I'm not the only one asking this question.

We've been told so often that our response to the problem should be to "follow the science". But science is not the same thing as authoritative pronouncements from government health agencies or even consensus of scientific experts and hidebound processes. The scientific method involves a hypothesis, a testing of the hypothesis and an analysis of the results. But the testing must be designed to be appropriate to the situation at hand and not simply the following of standardized procedures. And there must be free interchange of ideas with give and take from multiple sources. There is no such thing as "settled science".

In retrospect it appears as if in this pandemic our reliance on centralized control cost thousands of lives. Those who think we would have been better off to rely on the federal bureaucracies to run the show should reconsider.

 

 

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