Why I Defend FDA Commissioner Stephen Hahn

Edit: Dr. Fauci’s remarks in KHN interview.

(CBS) COVID-19 vaccine will be made available “on the basis of science and data,” FDA commissioner says.

Suspicion says Hahn is under pressure to approve a vaccine before completion of Phase 3 trials. I have been writing articles about caution with new vaccines. This is about the other side of the coin.

Clinical trials are supposed to safeguard reason with the power of statistics. In the minds of the public, and possibly you, they are a complete replacement for something they have no understanding of. This is natural. It’s also a kind of intellectual poison.  There is no replacement for intellect, except to rely entirely on expert judgment, which you might fear is caving to political pressure.

In a court of law, expert witnesses for the prosecution and defense compete for the minds of the jury. We think this works better than the alternatives. It could work better here.

If you are interested in Hahn’s decision making process, how he thinks, you have to go beyond trials-phase 1,2,3. Plans, procedures, and  statistics cannot replace human reason.   Human intelligence connotes adaptation to circumstances as they evolve. You have to understand Hahn’s intelligence, which requires a little more about vaccines than the media provide.

With apologies to Reuters, look at Scientists see downsides to top COVID-19 vaccines from Russia, China. Quoting,

Researchers have experimented with Ad5-based vaccines against a variety of infections for decades, but none are widely used. They employ harmless viruses as “vectors” to ferry genes from the target virus – in this case the novel coronavirus – into human cells, prompting an immune response to fight the actual virus.

This sounds informative, but it leaves out a crucial safety question, discussed in Why I Would Not Take the Russian or Oxford – AstraZeneca Vaccines – Part 2. Quoting the nut of it,

After a while, we’re ready to harvest the culture medium for the virus we want, the Kamikaze, purifying it of the helper virus. We don’t want the helper virus in our vaccine, because it  does not contain the code for the spike protein, and it can replicate…

Very small quantities of live, helper, adenovirus are present in the finished vaccine product.  Supporters of these vaccines make these claims:…

Don’t trust me. Read the abstract of (PubMed) Evidence of frequent recombination among human adenoviruses. With elisions so you can see the point:

Genome stability is a prerequisite for the production and use of adenoviruses for therapy of genetic diseases and cancer….Our results suggest that recombination among circulating adenoviruses is very frequent and plays an important role in shaping the phylogenetic relationships of adenovirus genomes.

This line of reasoning now presents:

  • For adenoviruses to be used, they must be stable.
  • Adenoviruses frequently recombine. Hence they are not stable.
  • Adenoviruses must not be used.

This is similar to unsafe. Maybe this makes you uncomfortable; you’d like to disengage. It’s not your specialty, you don’t know anything about it, so you’d rather rely on experts, who you don’t trust either. But you can’t disengage, because you are a juror in the court of public opinion.  With or without you, there will be a verdict, You may as well help it be a good one.

So how do you use the above? It’s  an argument, not a fact. You can show it around to prospective “experts”. And like a juror, you might see something in a face, a tone, or a gesture that inclines you to doubt. Or you might find their reasons  unconvincing.

A while back, I’m embarrassed to say, I cited the Thorotrast debacle as preventable by thorough clinical trials. It is actually exactly the opposite. It’s an example of a disaster that could have been prevented only by human reason, because the cancers produced by Thorotrast take 20+ years to develop.

The only way the Thorotrast disaster could have been prevented is by recognition, in radioactivity introduced into the body, of similarity to unsafe. In this phrase, we stumble on what a court would call professional expertise. An expert should have the ability to recognize  two basic similarities:

  • Similarity to unsafe. “It looks dangerous.”
  • Similarity to safe. “It looks safe to me.”

Similar to unsafe should require extensive, prolonged, exacting investigation in every avenue of potential hazard. Novelty enhances this similarity. Familiarity, or precedence of use, reduces it.

Some novelties remain similar to unsafe, because the current state of knowledge does not resolve the difference. (PubMed) Evidence of frequent recombination among human adenoviruses offers no more foundation than quicksand.

Similar to safe requires another faculty embedded in professional expertise, using what we call good judgment to abbreviate investigation. Influenza strains mutate yearly. But vaccines manufactured by established processes do not repeat clinical trials. They are accepted as similar to safe.

By now, you should have one  takeaway: Vaccine safety is not served by a mechanical process, 1,2,3.  That process is a theme with variations, working in concert with expertise, which unlike the scientific method, still resists bottling.

What are Commissioner Hahn’s choices? The nearest term options are controversial ones, to approve a vaccine that has completed:

  • Phase 2 or 3, but highly novel, with a similarity to unsafe.
  • Phase 2,  but less novel, with less or no similarity to unsafe, with high immunogenicity.
  • Phase 2 or 3, which appears inherently safe, but less immunogenic, and hard to store and transport.

Hahn knows that within 6 months of the above, more and probably superior options, free of traces of live virus, will have completed phase 3. During the wait, people will die.

Dr. Fauci has another criteria. (Kaiser Health News) There’s a legitimate way to end coronavirus vaccine trials early, Fauci says. Quoting,

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,'” Fauci said.

Yet  numbers do not replace  judgment and ethics.  A vaccine could reduce fatalities, with unapparent change in average severity. What of  the risk that the trace helper virus of an adenovirus vaccine does something horrible long after clinical trials? Are ethics served by immediate need or unknown risk?

With a little effort, and a little help from the media, you can think along with Hahn. And maybe, when he makes a decision, you won’t have to cry “foul!” The jury is still out, and you’re on it.

Will the media step up? These are tough times for the inquiring mind.







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