Convalescent Plasma Treatment May Lead to the Political October Surprise

By  //  August 23, 2020

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Everybody is predicting an “October Suprise” that will have an impact on the election.  Maybe it will be planned.  Maybe it will just happen because that is just the way that the pieces will fall into place.  (Anadolu Agency image)

Everybody is predicting an “October Suprise” that will have an impact on the election.  Maybe it will be planned.  Maybe it will just happen because that is just the way that the pieces will fall into place. 

I think that the “October Suprise” is going to be related to the Convalescent Plasma Treatment that Trump authorized on August 23, 2020, at this news conference.

(My opinion) — I think that the approval of the Convalescent Plasma Treatment is the tip of the iceberg of a ripple effect of a bunch events that is going to end with the long-awaited double-blind clinical trial of the hydroxychloroquine + zinc + antibiotics that will finally prove without a doubt in anybody’s mind that the hydroxychloroquine + zinc + antibiotics treatment works when administered within the first 5 days of COVID-19 symptoms appearing.

I know what you are thinking … I have been playing too much progressive jackpot, but hear me out.  Let me explain my thinking.

What is Convalescent Plasma?

Convalescent plasma (from Wikipedia):

“Antiserum is a human or nonhuman blood serum containing monoclonal or polyclonal antibodies that are used to spread passive immunity to many diseases via blood donation.”

To put it in layman’s terms, doctors take blood from patients who have already recovered from COVID-19, extract out the antibodies, and those antibodies are then used to heal a person who is currently sick with COVID-19.

The red cross has been accepting donations from recovered COVID-19 patients since March 27, 2019 (since March 25 in NYC). 

In China, people were donating blood from as early as February 19, 2020.  So this is not something that “just happened”.  It is research that has been going on all over the world since the beginning stages of the COVID-19 pandemic.

Does HIPPA permit a covered health care provider to use protected health information (PHI) to identify and contact patients who have recovered from COVID-19 to provide them with information about donating blood and plasma that could help other COVID-19 patients?

Yes (short answer) — if you want the long answer you can read the official document from the Health and Human Services website titled “Guidance on HIPAA and Contacting Former COVID-19 Patients about Blood and Plasma Donation”.

When did the use of Blood Plasma to treat patients begin?

The first therapies for the treatment of diphtheria and tetanus began in the mid-1890s.  But they did not use a human serum at that time.  Instead of they used the blood plasma from horses since those animals were large enough to produce enough antibodies to protect humans.  Also, diseases from horses cannot be transferred to humans.

But COVID-19 plasma is coming from human donors, not horses, so don’t worry that your favorite racehorse is being abused (calm down animal rights activists, although humans are technically animals — but I digress).

What is the history of the COVID-19 Convalescent Plasma program?

Before August 23, 2020, when the FDA approved this procedure, the Mayo Clinic ran admission (and central record keeping) to the convalescent plasma program from the website uscovidplasma.org.  Since the FDA approved this procedure, this website is now shut down. It is still up for view, but not for doctors or patients to enroll in the program.

“While the program was never intended to be a randomized clinical trial, in the course of our work, Mayo Clinic and our collaborators observed potential signals of efficacy, among a diverse population and chose to share those data.  Our program hope is that the safety findings and possible efficacy signals could inform the body of knowledge about the use of convalescent plasma to modify the course of COVID-19.  We are facilitating additional collaborative trials and scientific study of convalescent plasma.  The program enabled possibly the largest study ever on the safety of convalescent plasma as a therapeutic option.  The EAP was highly successful in enrolling racial and ethnic minority participants, and women, groups historically underrepresented in clinical trials.”

This endeavor started with just 10 institutions that self-organized to research the use of convalescent plasma during the COVID-19 pandemic.

The project was funded with federal funds from the Biomedical Advancement Research and Development Authority”, as well as other government-funded organizations.  (Funded by our tax dollars.)

What was different about the Convalescent Plasma approach to FDA approval vs the hydroxychloroquine + zinc approach to approval from the FDA?

The main difference between the Convalescent Plasma approach to obtaining FDA approval over the hydroxychloroquine approach of obtaining FDA approval was the use of a central database to store all of the required records.

With the hydroxychloroquine approach, you had a doctor here and a doctor there stating what they observed with patients when they used hydroxychloroquine, and in many cases, this record-keeping was done AFTER the doctor had already treated the patient.  The result was a hodgepodge of record-keeping that in many cases was missing critical information.

With the Convalescent Plasma approach, because doctors pre-registered on the database and received preapproval to sign up patients in the study (and obtain the needed Convalescent Plasma), the record-keeping started before the doctor even saw the first patient.  The Mayo Clinic, which was running the study, had forms on the website that doctors were required to fill out.  (Yes, I am sure that proper medical privacy procedures were followed.  I am saying the general term “website”.) 

This insured that all of the data was submitted to the FDA included all of the information that the FDA was expecting to see.

From what I can see, this is the main difference between the two in terms of record keeping.  If the hydroxychloroquine + zinc + antibiotics treatment ran a central database for the record-keeping, the records would be a lot more organized, and the approval process would have less complications.  (This is assuming that is the reason for the problem and not politics.)

Why hasn’t a double-blind clinical trial been run for hydroxychloroquine?

The only reason I can think of why a double-blind clinical trial has not been run for the hydroxychloroquine treatment is that either people strongly believe that the hydroxychloroquine + zinc + antibiotics treatment will work or they strongly believe that the drug + zinc will not work. 

There are very few people that are in the middle.  Plus, with the media scare (politics at its worst), a lot of people are not just afraid that the hydroxychloroquine + zinc + antibiotics treatment will not work (not do anything), but it will kill them.

If the Convalescent Plasma treatment works, it will provide safety for the double-blind clinical trial of the hydroxychloroquine + zinc + antibiotics treatment option. 

This will help encourage people who believe in the drug to participate in the study knowing that if they are given the placebo, they are not going to die from non-treatment.

Can a double-blind clinical trial be done for both options in the same study?

I am going to answer the non-professional answer of “Yes”.  

Note: I am not a doctor, but I did work in a computer programmer support role for the Varicella vaccine.  So I have more than a layman’s understanding of the topic, but I am not a doctor.

Here is how I can see the clinical trial is set up.  Every patient is given both a blood transfusion and the drugs.

• Group 1: Gets Convalescent Plasma, and placebo drugs and vitamins.

• Group 2: Gets standard blood with no antibodies, and hydroxychloroquine + zinc

Both double-blind clinical trials are done. 

These are the 4 options that one would expect.

Results for both groups are the same as what we see with untreated patients. (both treatments do not work)

Group 1 has a higher recovery rate than group 2 and untreated patients. (Convalescent plasma treatment works, but hydroxychloroquine + zinc does not work)

Group 2 has a higher recovery rate than group 1 and untreated patients. (hydroxychloroquine plus zinc works, but Convalescent plasma treatment does not work)

Group 1 and Group 2 have a higher recovery rate than untreated patients (both the hydroxychloroquine plus zinc option works and the convalescent plasma treatment works)

Summary

The hydroxychloroquine plus zinc treatment is intended to treat patients who show symptoms with the first 5 days.  Convalescent plasma treatment can handle much sicker patients.  

On the other hand, the hydroxychloroquine + zinc treatment can be done in an outpatient setting in a doctor’s office or outpatient hospital clinic and it is a lot cheaper.  The convalescent plasma treatment is a lot more expensive and requires a patient to be in the hospital until they recover.  5 days in a hospital costs $60,000.  The hydroxychloroquine + zinc treatment costs $30.  That is a huge financial difference. 

So even if it turns out that both treatments work, in reality, the hydroxychloroquine + zinc treatment will be used for patients who are in the early stages of COVID-19 (within the first 5 days after showing symptoms), while the convalescent plasma treatment will be reserved for patients who are farther along in the COVID-19 disease or hydroxychloroquine + zinc + antibiotics treatment is not working or the hydroxychloroquine + zinc + antibiotics treatment is not the right choice for a given patient.

In any case, I foresee the hydroxychloroquine + zinc treatment following in the footsteps of the convalescent plasma with the creation of a central database for record-keeping from various doctors. 

I also foresee both clinical trials being done at the same time so that barriers that currently exist with a clinical trial for both treatments can be overcome.  Patients and doctors do not have to be afraid that if a patient does not get the treatment they will get sicker and die. 

This will help more people to volunteer to participate in both of these clinical trials.

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