Covid 19: NEJM and former CDC director launch stinging attacks on US response
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3925 (Published 08 October 2020) Cite this as: BMJ 2020;371:m3925Linked Opinion
Politics and public health in America—taking a stand for what is right
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Dear Editor,
I was glad to see Janet Menage's rapid response asking "What does this mean?" because I, too, want to know what the CDC meant by:
"Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/μL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen”.(1)
As Public Policy Director of a nonprofit with a mission to restore scientific integrity to public health policy, I have stayed on the sidelines of the debate about whether or not SARS-COV-2 virus actually exists, choosing instead to focus on educating about existing inexpensive treatment protocols that are being marginalized. No matter what the cause, people the world over are being hospitalized and dying, and the first step in eradicating fear is to provide hope. Knowledgeable practitioners have been using nutrient and oxidative therapies, as well as non-patentable drugs, to successfully address viral infections for decades and longer, and those same methodologies work even if the exact viral cause of the symptoms is unknown. They are working for those who "test positive" for COVID-19. (2)
But the world has been devastated by the unprecedented response to a "novel virus" with severe shut downs and restrictions, and in some places, such as my home state, there is no end in sight to the measures, despite the existence of effective treatments, the fact that more than 99% of individuals are not at risk of severe infection outcome, and the peak in fatalities was over months ago. We are told to continue distancing, masking, and waiting for vaccines, which are unlikely to provide a safe or effective solution, based on the history of coronavirus vaccine development and the results emerging from clinical trials.
We all deserve to know the truth about this virus and what PCR test results really mean.
(1) https://www.fda.gov/media/134922/download
(2) https://healthyimmunitynow.org
Competing interests: No competing interests
Dear Editor,
Holding an opinion against the manner of functioning of a central health organisation whom people trust and turning indignant at the 'state of affairs' are two different responses, measured or not.
Further, whether a medical journal of repute should take a political stand is a vexatious issue that may set a precedent for times that surely will last long. Whether the health situation is so compulsively desperate that all medical journalistic ethics can take a backseat is bound to be debated.
Last, whether the enlightened readership of a prestigious journal do at all require such a call can be contentious--a remarkable day-happening in the history of medical journalism.
Prof Murar E Yeolekar, Mumbai.
Competing interests: No competing interests
Dear Editor
“The best decisions are based on the best science”, the article quotes.
However, the CDC states on page 39 of its 13th July 2020 document entitled,’ CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel For Emergency Use Only Instructions for Use’ (1) :
“Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/μL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen”.
What does this mean? And is it the “best science”?
Competing interests: No competing interests
Re: Covid 19: NEJM and former CDC director launch stinging attacks on US response
Dear Editor,
Responding to Bernadette Pajer and Janet Menage.
Clarifying the statement provided by FDA in the SARS CoV2 PCR method document.
"Since no quantified virus isolates of the 2019-nCoV are currently available, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/μL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen”
One essential step in method characterization is to determine the limit of detection (LoD). As this requires a quantitative readout from the assay, one needs to use a precisely quantified reference substance as calibrant, ie it needs to be known in the reference that the SARS CoV2 RNA genome is exactly present at a concentration of X copies/µl.
This statement simply means that this exactly quantified isolate is not availabe, but the isolate are available. The exactly quantified reference substance is available in the form of in-vitro transcribed RNA. This was used for the quantitative studies to establish the LoD.
This statement does NOT mean that no isolates are available. The CDC distributes currently 19 different SARS CoV2 isolates.
A very simple analogy:
apples = SARS CoV2 isolates
Do you have apples available?
Yes
Do you have buckets of exactly 50 apples available?
No
But you do have apples in store?
Yes, we do and we sell them in buckets, but some buckets contain as little as 40 apples and some may contain up to 60 apples.
Competing interests: No competing interests