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SPECIAL COVID-19 Update: Clarification on Vaccine Update – The Process of the Science is Faulty

By Dr. Arthur Lavin

Glossary

  • Virus– a type of germ that consists solely of a bit of genetic material (DNA or RNA) wrapped in a protein coat.  The coat gets the genes into the target cell where the genes force the cell to make zillions of new viruses, and on it goes.
  • Coronavirus– a species name of a number of different viruses.  Called corona because its protein coat is studded with spike shapes that form a crown, halo, or corona of spikes
  • SARS-CoV-2– the specific name of the new coronavirus
  • COVID-19-the name of the illness that the new coronavirus is causing
  • Endemic– an illness always present in a region.  One could say strep throat is endemic in the US
  • Epidemic– a sudden burst of an illness that comes and goes over a limited time
  • Pandemic– an epidemic that bursts across the world not just one region
  • Spreadability– how contagious is the disease, how many people will end up infected
  • Severity– what harm does the disease cause, in terms of  how sick you get and how many it will kill
  • Mask- a mask is a loose-fitting cloth or textile that covers the mouth and nose loosely.  A surgical mask is a mask used in surgery
  • Respirator-  for the purposes of the COVID-19 pandemic and other respiratory illnesses, a respirator is a mask that fits very snugly or tightly to the user’s face.  An N95 mask is a respirator.
  • Personal Protective Equipment (PPE)- PPE are any item that covers any part of the body with the design and intent of keeping viruses in the environment from infecting the wearer of the PPE. PPE’s include all masks (which includes respirators), face shields, eye shields, gloves, gowns.
  • Ventilator- a ventilator is a machine that can force a person unable to breathe to inhale and exhale and control both effectively.  They are sometimes called respirators, but during this pandemic the word respirator is now reserved for reference to a tightly fit mask.
  • Live Virus Swab– this is the swab which attempts to swipe live virus from one’s nose or throat to see if you are currently infected.
  • Antibody Test- (aka serology test) this is the blood test which looks for antibody to the SARS-CoV-2 virus to see if you have been infected in the past.

 

Clarification on Recent Reports on Vaccine and  Medication Development

We have all been very pleased to receive even hints that lab work might yield a drug, or even better, a vaccine, to end this pandemic, and the sooner the better.

Readers of Real Answers have read about early reports, of a vaccine by Moderna, and of the drug Remdesivir.

Recent observations on both studies justify issuing this clarification on the scientific process, and how both early reports violate the integrity of that process.   Finding a medication or a vaccine for a new germ is a very, very hard process. Candidate vaccines and drugs often hint at success, only to be found out to be very weak, ineffective, or harmful.  So the process of figuring out if Medication X or Vaccine Y really will stop the pandemic and really will be safe it difficult.   Tests have to demonstrate real effect and real safety.

Skipping steps, acting on hope, usually ends in disappointment and too often, disaster.

Keep in mind that science is really very good at proving a claim is not true, not that a claim is true.  That flies in the face of how we usually think of science.  After all, don’t we get an X-ray to find out if a bone is broken,and the science tells us what is true- the bone is broken or it isn’t?   Yes.  But those X-rays are right most of the time only because when that technique was being developed, hundreds of approaches to getting these images were tried and proven to not work, yielding the path that works very well.

How Can You Prove a New Therapy Does NOT Work?

Again, proving something does not work is the power of science, we find what does by exhausting attempts to show a new idea’s failings, left with the conclusion it works.

So, how do we prove a new therapy does NOT work?

Two major ways:

  1. Test it on large numbers of people to see the pattern of its impacts.
  2. Make sure people who did not do the study read it and find how the study design is misleading.

Over, and over, and over again, in good science, we see items that looked good fail when tried many times and when other people look carefully for mistakes.  These approaches have been found to make the difference between finding a real remedy and not.

The Vaccine Spark of Hope

Just this week we were all thrilled to hear reports of 8 people who got vaccinated whose blood stopped the SARS-CoV-2 virus from reproducing.  It really does open the door to thinking, maybe this new technology, the new world of this RNA vaccine, could stop a virus, could end this pandemic.  It is exciting.

But today, reports are emerging that force us to hold back hope for time, to pause on judgement.

The problem is that companies doing research are announcing very preliminary leads to all of us, the public, with lots of fanfare, before doing the necessary work to give us confidence the hope will remain tomorrow.  In this case Moderna, the company, announced that 8 people’s blood stopped the virus in the lab from copying itself.   It has not done lots of tests (failed point 1), and it has not asked other scientists to poke holes in their work (failed point 2).  Is it at all relevant that Moderna’s value went up billions managing its announcements this way?

Here is a good take on this problem: https://www.statnews.com/2020/05/19/vaccine-experts-say-moderna-didnt-produce-data-critical-to-assessing-covid-19-vaccine/

The Medication Spark of Hope

Sadly, and perhaps very interestingly, the same problems are emerging from the study on the promising drug Remdesivir.

Remember an earlier post presenting what we know about this study?  It showed only modest benefit, a few days less in the hospital, a very slight decreased mortality rate.  Again, the impact was quite small, and again, the real impact was that a door opened, here was one drug that seemed to slow the virus, maybe that means there will be others that will do better.

But it turns out that this company also failed both steps of science, which demands that all is done to find out if a claim is false.

This study was announced to the public nearly 3 weeks ago.  Even today, the details of the study have not been released for review by others, and the numbers studies were small.

And, why is it that another study of Remdesivir done around the same time showing no benefit got little attention.

Here is another take on the vaccine and medication story:https://www.washingtonpost.com/opinions/2020/05/19/rush-share-good-news-covid-19-drugs-is-undermining-science/

BOTTOM LINES

  1. It is exciting to hear good news, especially about a deadly pandemic.
  2. It is wonderful to have hope sparked, to as they say, open the doors, even just a bit, to possibilities.
  3. But. Only good science will deliver a vaccine and/or a medication that works.  That is the ONLY path that led to other vaccines and medications that work.  Tireless attention to detail, testing the results in vast numbers of trials, and making sure other people see the very details of your work to find mistakes.   Do this and hopes can be translated into realities that you can bet your life on.  Do not do this and hopes remains just that, left with nothing to have a life rely on.
  4. Today it must be observed that the groups that did the very preliminary work on the RNA vaccine for this virus and the Remdesivir medication skipped the steps necessary before coming to the public to tell us a step forward has been reliably taken.  
  5.  So sadly, the hope this has all raised really needs to be put on hold.  Further, we must all ask all companies, all research groups, from dabbling in PR and Marketing, and stick to good hard science.

Here is to real progress being made.  I still hope it will come, I do not see it in place yet.

To your health,
Dr. Arthur Lavin

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