Setting the record straight on COVID care

Re: “Take live and let live approach on COVID shots,” by Henry Whitley, Oct. 20: Vaccinations against COVID remain the most effective and safest approach to the COVID epidemic.  Masks have been proven effective in reducing the spread of the COVID virus and are not silly.

Hydroxychloroquine, early in the epidemic, was given emergency use authorization. It has been approved and licensed for use in malaria and autoimmune disorders such as rheumatoid arthritis and lupus. After multiple studies run by researchers at medical schools including Oxford University in England and clinics like the Mayo Clinic, it was found that hydroxychloroquine did not have clinical benefits over placebo in treatment or prevention of COVID. 

Also, there are significant side effects including prolonged QT interval on EKG and resultant ventricular tachycardia, eye problems, seizures, liver problems and death, so it is not safe or effective, and its EUA was revoked in June 2020.

Ivermectin was never given EUA. It is licensed for treatment of some parasitic infections. As any licensed product can be used by any physician for off-label purposes, it can be prescribed for COVID. FDA officials have stated the above, and that has been erroneously interpreted and reported as approval of ivermectin for COVID. That is misinformation. It is clearly not an endorsement by the FDA for its use in COVID, and it absolutely has not been approved or licensed. 

Adequately powered randomized, controlled studies performed by reliable researchers have failed to find clinical benefit of ivermectin for COVID patients regarding hospitalizations, deaths or progression of the illness. Ivermectin can cause low blood pressure, hallucinations, confusion, seizures, coma and other side effects. So. again, it is not effective or safe, and there is no flip-flop.  

EUA allows use of unapproved medical products or unapproved uses of products already approved for other purposes during public health emergencies when other approved treatments are not available. Patients must be given fact sheets regarding the product and the EUA. Unapproved medical products must meet the following criteria before receiving EUA:

1. Manufacturing data to assure quality and consistency must be provided.

2. Known and potential benefits must outweigh known and potential risks.

3. Interim or final analysis of a Phase 3 clinical efficacy and safety trial with thousands of randomized and controlled patients (after completion of Phase 1 and 2 studies) must be provided.

4. Ongoing analysis must continue until licensed or rejected.

5. Ongoing surveillance after licensure through the vaccine adverse event reporting system, vaccine safety database and other methods must be undertaken.

Aaron Siri, quoted in the letter above, is an attorney whose fame and fortune are based on his anti-vaccine cases and writings. The Salk polio vaccine that mothers in the 1950s considered a miracle and the original measles vaccine underwent pre-release placebo-controlled, blinded studies. At this time, with older vaccines being effective, to subject children to placebo in a blinded study would be immoral and unethical, so newer childhood vaccines have been compared to older products and not placebos in their clinical studies. 

Implications of shortcuts in research and of greed in this process are dishonest or at least disingenuous and prejudicial. COVID vaccines have been and continue to be subject to rigorous study. COVID vaccines have been approved and licensed based on their effectiveness and safety.

The World Health Organization, NIH and other respected groups recommend against use of ivermectin and hydroxychloroquine in COVID prevention or treatment.  They strongly recommend the vaccines.  Attorney Siri generally opposes vaccines, and many conspiracy sites discourage COVID vaccines and promote ivermectin and hydroxychloroquine. 

The Nobel Prize for Physiology and Medicine was awarded to Kariko and Weissman last month for discoveries that enabled the development of effective mRNA vaccines against COVID-19.  I would recommend that you follow the Nobel Committee, WHO, NIH and others and get vaccinated for COVID and avoid ivermectin and hydroxychloroquine.

People are entitled to their own opinions, but not their own facts.

Lawrence Krabill, M.D.

Wilson

Editor’s note: The Times waived its 350-word length limit to permit the writer a fuller response due to his expertise as a physician.