Epidemiologist Neil Ferguson, who created the highly-cited Imperial College London coronavirus model, which has been cited by organizations like The New York Times and has been instrumental in governmental policy decision-making, offered a massively downgraded projection of the potential deathtoll on Wednesday. (See link for article)
___________________
**Comment**
A few key quotes:
Ferguson’s change of tune comes days after Oxford epidemiologist Sunetra Gupta criticized the professor’s model.
“I am surprised that there has been such unqualified acceptance of the Imperial model,” Gupta said, according to the Financial Times.
The important issue Gupta’s team raises is that COVID-19 was spreading much earlier than suspected and concludes that as many as half of the people in the United Kingdom have already been infected by COVID-19.
Which brings up the probability of this happening in the U.S. as well.
My entire family, as well as many neighbors and friends feel we’ve already had COVID-19 earlier this year and live to tell the tale.
But, like The Wall Street Journal’s writers point out, it is quite possible that “A universal quarantine may not be worth the costs it imposes on the economy, community and individual mental and physical health” and that statisticians should be called upon to “evaluate the empirical basis of the current lockdowns.”
Cuomo admits his decision to quarantine everyone at once was ‘not the best strategy’ and that he is ‘working on’ release of coronavirus antibody test that will allow people to go back to work
Dr. Birx Admits Initial Death Estimates Too Extreme
In a nutshell, she admits that the CDC STILL does not have an accurate test as well as the fact that the models used were faulty and don’t reveal what’s happening in reality (South Korea, Italy, Spain).
Germany is not suffering from a raging infection outbreak because they have been conducting accurate testing since the onset of their first infection. The World Health Organization (WHO) offered the US CDC the test from Germany – and yet CDC made the deadly decision to develop their own test.
The German test was ready and available on January 17th 2020 – including published details of the protocol.
The test had also already been validated for specificity to SARS-2-CoV – using human samples – meaning it would not accidentally give false positives for other respiratory viruses – and also meaning that it would not give a false positive from human genes in the human samples.
Weiler, points out how the CDC has a history of insisting upon their own testing so they can corner the market, putting them in direct competition with the private sector. He rightly points out what all of us in Lymeland have been screaming about:
It isn’t ethical to be in charge of public health AND own licenses to products.
Agency scientists should not be allowed use US taxpayer’s funds to develop “their own” test. CDC, and HHS, in fact, should not own anything.” James Lyons-Weiler
Those suffering with tick-borne illness have had to work about the faulty testing issue for over 40 years. Doctors to this day are sending people home with a false sense of security after they test negative on the only approved CDC 2-tiered tests available. For decades the CDC has vilified small CLIA-approved labs doing more specialized testing for Lyme disease. On their website a while back they actually had the nerve to call these tests “home-brewed,” always casting a negative light on ANY test other than their’s.
I pray this COVID-19 testing fiasco shines a light on a very real problem – the CDC is a captured agency.
THE TRUTH ABOUT HYDROXYCHLOROQUINE (Plaquenil) IN THE TREATMENT OF COVID-19
By Dr. Alain Mass
Since the intervention of the President of the USA, Donald Trump announcing that the FDA approved Hydroxychloroquine in the treatment of COVID-19, the news spread that a treatment was now available. However, on the same day, the FDA denied having given the approval for this drug. We are now facing questions and requests from patients for this medication that medical professionals cannot give without going astray from the current standard of care established by the FDA. More concerning is the consequences on the epidemic and on lives to refrain the prescription of Hydroxychloroquine. Is Hydroxychloroqine really a treatment for COVID-19? Is there any alternative treatment? Is Hydroxychloroquine really dangerous to the point to limit or to delay its use until studies confirm the validity of its use in the treatment of COVID?
Didier Raoult, M.D. is a Professor in Infectious Diseases in Marseille, France. He is ranked as the first world expert in communicable diseases by the online resource, http://www.expertscape.com. He is the leader in France in the research on COVID-19. He is also an expert in Plaquenil since he has worked for the past 10 years on Plaquenil to treat other diseases. He is currently the European voice who promotes the use of Hydroxychloroquine against the position of the FDA. As a French native, I was able to follow the interviews that the Professor Didier Raoult gave and because lives may be saved today with the use of Hydroxychloroquine I feel an ethical duty to share the expert advice that supports the use of Hydroxychloroquine (Plaquenil).
Plaquenil has been used for the past 70 years as a drug to treat and to prevent malaria. Plaquenil’s safety has been proven, having been used by millions of people during this period. Its safety profile is well-known, which is not the case of newer drugs that may be safe in the early studies, but often turn out to be dangerous over time.
If, two months ago, you would have to go to Africa, Asia or any endemic zone of malaria the same doctor who, today, refuses to give you Plaquenil, based on the FDA instructions, would have given you Plaquenil for weeks or months without any hesitancy and probably even without looking up the potential side effects. Malaria may kill and the prevention of a potential lethal disease has justified for the past 70 years this practice that nobody never discussed. Suddenly, in 2020, Plaquenil became a dangerous drug when there is a threat of crisis in Plaquenil supply. Is Malaria much worse than COVID-19? Is the risk of being bitten by a mosquito in a hotel much higher than catching COVID-19 in your local supermarket full of sick individuals or by touching door knobs where the virus can stay 9 days?
Three studies have been published recently by Chinese doctors showing the efficacy of Plaquenil on COVID-19. One study reported by the Pr. Didier Raoult, showed the eradication of coronavirus in 75% of patients with hydroxychloroquine alone and when combined with Azithromycin an eradication in 95% of cases. Pr. Raoult published a few days ago his own study showing similar results. Pr. Raoult thinks that Chinese doctors are reliable. They were the first to face this epidemic, have the largest experience in COVID-19 patients and have already published more than 20 studies.
The usual rule in Medicine requires protocols, well conducted double-blind randomized studies, studies at large scale to officially promote a medication. Dr. Hahn, director of the FDA states:
“We must ensure these products are effective: otherwise we risk treating patients with a product that might not work when they could have pursued other more appropriate treatments”.
The problem is that we do not have yet these “more appropriate treatments” and people in ICU cannot wait.
Today, there is no other FDA approved drug to fight against COVID-19. Today, while people may be between life and death, when some do not know how fast and severely they will deteriorate, Plaquenil, which is FDA approved for the treatment and prevention of malaria and for some inflammatory diseases, is still not approved for the treatment of COVID. The FDA ensures the safety and the good use of medications and physicians who today refuse to give Plaquenil, strictly, follow the FDA instructions in your best interest. Is it really so?
The history of Medicine can also teach us lessons. One oral antidiabetic medication (Metformin) was introduced in Europe in 1950 and in the USA in 1995. It took 45 years for the FDA to authorize what turned out to be the basic treatment of diabetes. The first oral anti-diabetes medication was introduced in the USA in 1984. It took 14 years for the FDA to allow american citizens to have tablets instead of insulin shots. It took 12 years for Alexander Fleming to convince his peers that penicillin was not a quackery resulting in the death of hundreds that was avoidable. How many victims from COVID-19 will it take until pragmatic therapeutic approaches are taken? The concept of the patient’s best interest has to be reconsidered in times of crisis. Yes, well-conducted studies are necessary and should guide our medical practice. Sometimes, however, when it is urgent, the risk/benefit ratio may be the only guide.
The common Plaquenil side effects may include nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in your ears, mood changes, nervousness, irritability, skin rash, itching, or hair loss. As to the serious side effects, their frequency according to the medical website Medscape is not well defined. Plaquenil may also cause severe eye damage but only when taken for a long term. This concern is certainly not relevant to a 5 day treatment. Plaquenil may have an effect on the heart visible on an electrocardiogram (EKG) (prolongation of the QT interval) as does Zithromax. The concern is the risk of cardiac arrhythmia. The risk is even greater when Plaquenil is combined with other drugs that also prolong the QT interval on EKG. A study in 2018 concluded that more studies are needed to evaluate the clinical significance of this EKG abnormality. Pr. Didier Raoult who has used Plaquenil for the past 10 years in his clinical practice and research writes that the combination of Hydroxychloroquine (Plaquenil) with Azithromycin (Zithromax) was a concern but has not yet been shown to cause EKG problems. An EKG is advisable before starting Plaquenil. Any prolongation of the QT interval requires the approval of a cardiologist to use Plaquenil. In his interview on 03/23/20, the Pr. Raoult speaks of an hypothetical but possible risk of arrhythmia that is more relevant to patients who present with multiple diseases or in the ICU setting.
Drug interaction: Plaquenil may interact with acetaminophen, cancer medications, tuberculosis medications, birth control pills or hormone replacement therapy, arthritis medications, ACE inhibitors, antibiotics, antifungals, cholesterol medications, HIV/AIDS medications, NSAIDs (non-steroidal anti-inflammatory drugs), or seizure medications.
Side effects must always be correlated with their frequency, and with the risk/benefit ratio. Any medication may have serious side effects. Pr. Raoult, expert in the use of Plaquenil in his interview on 03/23/20 seems to be very annoyed by the warning about side effects and goes up to stating that it is purposely done like to “frighten people with ghosts”. Again, He insists on the fact that several millions of individuals took Hydroxychloroquine over the past 70 years. He does not hesitate to say that the fear of side effects due to Hydroxychloroquine and Azithromycin (Zithromax) does not make sense.
The risks of COVID-19 in a selected population at risk are serious and potentially lethal. In people at high risk of dying from COVID-19, the risk/benefit ratio favors the use of Plaquenil. Pr. Raoult, in his interview on 03/23/20 states that when there is respiratory insufficiency the virus is almost not or no longer detectable. When patients start having severe respiratory insufficiency, when patients are admitted in ICU, it is just too late to initiate Plaquenil. The virus is already gone. It is the remaining inflammation (cytokine storm) that is a life threat. According to the Pr. Raoult Hydroxychloroquine should be initiated when COVID-19 becomes moderate or when patients start getting worse. Plaquenil should be used when the virus is multiplying not when it is almost or totally gone.
Focusing on serious side effects without considering their relative frequency of occurrence and without taking into consideration the immediate life-threatening status and the absence of other alternative therapy causes an unrealistic and unjustified threat and fear on a medication that has the ability to save lives.
I understand that the authorization to use Plaquenil in the treatment of COVID-19 may lead to unjustified use of this drug where the risk/benefit ratio would not favor the drug, a shortage of this medication and the impossibility to give to those who really need it, for COVID-19 or for other indications. Providers should determine based on their clinical judgment and ethics what to do. However, today people are in ICU, others will have to be admitted in ICUs. These people cannot wait for studies to be completed.
Alain Mass, M.D.
Board Certified in Family Practice
contact@massfunctionalmd.com
Coronavirus and Plaquenil in the medical literature
A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data
ByJOHN P.A. IOANNIDIS
MARCH 17, 2020
A nurse holds swabs and a test tube to test people for Covid-19 at a drive-through station set up in the parking lot of the Beaumont Hospital in Royal Oak, Mich.PAUL SANCYA/AP
The current coronavirus disease, Covid-19, has been called a once-in-a-century pandemic. But it may also be a once-in-a-century evidence fiasco.At a time when everyone needs better information, from disease modelers and governments to people quarantined or just social distancing, we lack reliable evidence on how many people have been infected with SARS-CoV-2 or who continue to become infected. (Article in link)__________________
**Comment**
Key quotes:
The data collected so far on how many people are infected and how the epidemic is evolving are utterly unreliable.
Reported case fatality rates, like the official 3.4% rate from the World Health Organization, cause horror — and are meaningless.
A population-wide case fatality rate of 0.05% is lower than seasonal influenza. If that is the true rate, locking down the world with potentially tremendous social and financial consequences may be totally irrational. It’s like an elephant being attacked by a house cat.
A positive test for coronavirus does not mean necessarily that this virus is always primarily responsible for a patient’s demise.
The following article is a “Must Read” as it points out what the Lyme community knows all too well: The CDC can not be trusted. History shows it has severe conflicts of interests by owning licenses and patents that directly interfere with testing and diagnosis of numerous diseases – including COVID-19 & Lyme.
CDC’s Deadly Testing Fiasco: Centralization of Public Health Authority a Threat to National Security
James Lyons-Weiler
Editor In Chief at Science, Public Health Policy, and the Law
This is a companian article to augment the first of six Unbreaking Science episodes dedicated to insuring that those who are responsible for the failures of a rapid and effective response to the COVID-19 outbreak are held responsible. The article and the episode are complimentary – that is they overlap in content, but each has some unique information not found in the other. I recommend the video first, followed by a read of the article.
By the end of this first article and episode, the public will understand that
WHO Offered the US a Perfectly Good, Validated Test
CDC Refused, Wanting “Their Own”
This is Not the First Time CDC Wanted to Corner the Testing Market
HHS Whistleblower Chris Meekin Says CDC Lied to President Trump About the CDC’s Testing Abilities
Due to Capacity Alone, CDC is Incapable of Mounting an Effective Response to Outbreaks (Obvious National Security Issue)
Delay in Accurate Testing Could Help CDC – But It May Have Cost Us Everything
WHEN THE WORLD HEALTH ORGANIZATION offered the CDC a test – made by Germany – that had already been tested, one has to wonder who held the conversation within CDC leading to the disastrous conclusion that CDC should make “their own” test. One also has to wonder what factors went into play and which were considered. Most importantly, one has to wonder how much more time the US and its medical infrastructure would have had if patients were not released from the Princess Cruise ship and unknown numbers of other places if they had not tested negative due to CDC’s faulty test.
Whoever made those fateful decisions made them according to the status quo of the CDC – they prefer that which leads to massive amounts of positive revenue, regardless of the effect of that decision on safety.
The prevention paradigm at CDC displaced the rest of allopathy completely in the 1980s. David Lewis recalls this switch from controlling disease via contact tracing and use of treatments that prevent new infection (prevent tranmission) to the vaccination model – in which the vaccines were represented as preventing “new cases” via the prevention of symptoms following transmission. Most people think that vaccines prevent infection. They only do so if they reduce viremia – the growth of viruses – or bacterial growth – in someone who already has an infection. Vaccines can pass as “effective” if they suppress symptoms but fail to prevent infection.
Drugs that treat virus infections prevent the next infection by reducing viremia to the those where new infections are prevented. “Effective” when evaluating drugs is determined by testing for the presence of the virus – an assessment of the person who has been treated. “Effective” for a vaccine is defined as the presence of antibodies – and thus the assumption is that the next person will also be vaccinated, so if transmission still occurs, as is known in mumps, rubella, pertussis and most likely measles – the next person will not develop symptoms, even though the virus or bacterium might reach them from another vaccinated individual.
World Health Organization Offered CDC An Accurate Test: CDC Refused
Germany is not suffering from a raging infection outbreak because they have been conducting accurate testing since the onset of their first infection. The World Health Organization (WHO) offered the US CDC the test from Germany – and yet CDC made the deadly decision to develop their own test.
The German test was ready and available on January 17th 2020 – including published details of the protocol.
For those who know how, it is trivially easy to design primer probe sets that are both sensitive enough to amplify tiny amounts of nucleotide material in biological samples. It is also also trivially simple to make sure the primers selected are specific for the target sequences, and will not amplify off-target sequences, such as other viruses and human sequences.
The test had also already been validated for specificity to SARS-2-CoV – using human samples – meaning it would not accidentally give false positives for other respiratory viruses – and also meaning that it would not give a false positive from human genes in the human samples.
The CDC’s penchant for having “their own test” has been their MO in my experience for some time. During the 2014 Ebola Outbreak, as Director of the Ebola Rapid Assay Development Conortium (ERADC), I called CDC to inquire if they would test a protoype of a novel test technology that would wick saliva into a glass bottle – and the wick would change color in the presence of Ebola virus particles.
Sadly, I was turned down cold. Upon asking why, the reply was “We have our own.” (All of this is chronicled in detail in “Ebola:An Evolving Story”. I then had to suffer witness to lies from CDC on the genetics of the strain circulating in three countries in west Africa – lies from CDC’s then director Thomas Frieden, who testified to Congress that there were no mutations in “this virus” (meaning Ebola isolated from patients in Africa). In fact there were at least 396 mutations (difference) between Ebola 2014 and Ebola from Zaire in 2005. I also had suffer witness to lies from Dr. Stuart Nichol who, when I asked about Frieden’s stunningly incorrect claim, told a rather large group of scientists on a secret (Obama-era) White House phone call that my question was unfounded because Ebola 2015 was “99.9999%” identical to the Zaire 1995 Ebola strain. That lie is also chronicled in “Ebola: An Evolving Story”. The mutations – all 396 of them – amount to a significant difference between Ebola 2014 and Ebola 2005.
Why would he refuse? Surely, he knew about the published variants. Why would they lie? Because they had a PCR test they wanted to bring to market for airport screening. “Their” test, I was told by Nichols – who was the individual who refused to test our prototype – was designed to be used on blood drawn from patients. I pointed out to him how unsafe drawing blood in an airport during an Ebola outbreak might be.
This time, with SARS-CoV-2, there was no need for a new test. The Germans had one. CDC cost us precious time by insisting that they develop “their own”.
How many clinical tests does CDC hold patents on? (UBS Info request)
The value of accurate tests at the beginning of an outbreak cannot be underestimated. It aids in identifying cases- then clusters. After the “boom”, however, the utility of testing is severely diminished to triage for quarantine, and when that becomes pointless, triage for interventions – access to increasingly rare medical care, including access to hospital beds.
The data from China tell us that about 80% of cases are mild – meaning 20% are serious.14% of patients will have serious ilness, and 6% will require intensive care. In the US, we have about 920,000 hospital beds check, of which we have only 740,000 community beds, and around 68,000 intensive care beds (American Hospital Association). A Johns Hopkins report has projected that we could need as many at least 1,000,000 general hospital beds, perhaps as many as 9.6 million if the outbreak is severe – and at least 200,000 intensive care beds, as many as 2.9 million if the outbreak is severe. They projected that the US may need at least 740,000 ventilators.
With the caveat that projections are dependent on what we do now, we clearly also don’t have enough ventilators. As SARS-CoV-2 infections spread across the US, predictions of a severe shortfall of ventilators for intensive care units throughout the country have caught every state off guard. According to the Johns Hopkins University, U.S. hospitals have a total of 160,000 ventilators — 62,000 full-featured ventilators, and 98,000 more basic ones that can be used in an emergency. The national stockpile is estimated to be an additional 20,000. Projections of the number of needed ventilators range up to 740,000. At $5,000 per ventilator, the estimated cost of 740,000 ventilators is $3.7 Billion.
PCR test kits like CDC’s use “primer probe sets” – segment of nucleotide sequences that match the pathogen’s sequence in carefully selected regions that make the probes specific to the pathogen. They are used in a reaction to make millions of copies of one or more target sequences.
I analyzed CDC’s primer probe sets to see if I could help identify the problem – or problems with their test. On 2/27/2020, I sent CDC the details of my analysis. Of the twelve pairs of primer probe sets, 1/4 of them had matches to human protein-coding genes. This means they could fail to amplify the viral target sequences. I also sent this information to the FDA. The problem is that reagents could be used up amplifying human genes – causing FALSE NEGATIVES.
My review took an afternoon. The FDA gave the CDC an Emergency Use Authorization to start distributing the test. The problem was that someone told the world that ONLY the CDC’s test would be considered valid- and that any competing tests would also have to receive an EUA. On Feb 29, FDA relented and allowed local labs to develop their own tests.
CDC had let it out that they wanted their test to also test for SARS and MERS – a far more complex test than the WHO test from Germany. This reveals a move to get a corner on the market and beat out competitors and making the test unnecessarily complex. Those considerations do not amount to much until we remember that if CDC has used Germany’s more accurate and readily available test, we would have stretched the time to the beginning of the curve – allowing all parts of society to figure out how to help bring an end to the pandemic. Instead, we are in the exponential part of the curve with cases rising steeply – an experience that was utterly unnecessary.
The CDC wanted to re-invent the wheel. We will see in this series that there is a common theme – US scientists pretending that we “need to better understand this virus” before we know how to react. In what could otherwise be a shining moment, US public health infastructure and the US medical enterprise is providing example after example of being unable – or unwilling – to perform lateral learning. We know everything we need to know to understand how we should react from China – now verified by the experience by Italy – and by comparison the outstanding successes in Singapore and Hong Kong, and to a lesser degree South Korea, who have experienced linear increases in the number of cases due to extensive testing and quarantine of people who have been in contact with those who test positive.
Anthony Fauci Admits Testing is “Not Working”
Dr. Anthony Fauci of the NIAID told a Congressional Committee: “Let’s admit it: the test is not working”.
Fauci told CBS News on Face the Nation:
“What we can say is that now that we have the private sector involved, we’re going to see an entirely different scene than we’ve seen the weeks previously, for sure.”
The US turning to the private sector sends a major signal: no trust in the CDC regarding testing accuracy and capacity.
On 3/17/2020, he told Hugh Hewitt that, in his opinion, it’s no one’s fault – it just “happened”. Just happened? That’s what a kid says when he knocks over and breaks the cookie jar trying to steal a cookie.
•HH: Now my last technical question has to do with the CDC and the testing breakdown. Was that because of regulatory capture? Was that because the CDC always prefers its own work? Was that simply because we were not, we’ve never, I think what the President was saying yesterday is while we’ve confronted Ebola and H1N1, we’ve never confronted as fast a moving virus as this one before that is so elusive to diagnose. What happened on the testing development?
•AF: You know, it was a complicated series of multiple things that conflated that just, you know, went the wrong way. One of them was a technical glitch that slowed things down in the beginning. Nobody’s fault. There wasn’t any bad guys there. It just happened. And then when we realized, when the CDC realized, and the FDA said both the system itself as it was set up, which serves certain circumstances very well, was not well-suited to the kind of broad testing that we needed the private sector to get involved in. The regulatory constraints, which under certain circumstances are helpful and protective of the American people were not suited to the emergence of this particular outbreak. So there was a confluence of a bunch of things. I believe now that the CDC and the FDA and the Department, that we’ve got it right now, because we’re handing much of it over to the private sector to heavy hitter companies that do this for a living. And I think what you’re going to be seeing looking forward is a major, major improvement in the availability of testing.
• HH: Was the glitch or anything about the production of the test President Trump’s fault? Or actually, let me put it more broadly, would every president have run into the same problem?
•AF: Oh, absolutely. This has nothing to do with anybody’s fault, certainly not the President’s fault.
In testimony to a Congressional Committee, Fauci told the US that the system was never designed to handle something like this – to which one Congressional representative replied “Well, that’s disturbing”.
On 3/19/2020, Fauci told Mark Zuckerberg in a rare interview on Facebook that the CDC had failed. He also said we should involve the private sector – the ones who can mass-produce the tests for clinical use. Showing an unbelievable lack of remorse or regret, Fauci told Zuckerberg that it (involving the private sector) was a
“good lesson to learn for ‘next time’”
Some time a go, I called for locally developed testing ahead of this fiasco. It is my considered opinion that CDC should not be involved “next time” – or at least those involved in the initial consideration of the offer from WHO for an accurate test should not be involved the “next time”.
The fact that the large medical facilities are making their own tests means the CDC’s test will be largely if not completely irrelevant THIS TIME – and if they are allowed to enforce their “all testing is to be validated by CDC”, well, we’re just a nation of dupes.The medical community has now developed nearly zero faith in CDC’s clinical testing abilities, and this is a reputation that is truly well-earned.
CDC’s deadly mistake is directly responsible for the death and permnent lung damage to come across the US. It is also a major factor in the economic downturn in which the stock market lost 20% of its value – a whollop that make be one of many to come.
Rosen Interview of HHS Whistleblower Chris Meekin
CDC not only completely botched the testing, which is absolutely essential in anyone’s opinion for resource allocation, contact tracing, and dispensing medicines: CDC also lied to the President.
“[A] former senior federal health official nominated to his post by President Trump, alleges that the delays in testing occurred because leaders at the Centers for Disease Control“lied” to the president, and to Health and Human Services Secretary Alex Azar, about the center’s ability to produce the kits.”
From my conversations with members of the task force, both inside and outside the administration,” Meekins told Sinclair in an exclusive interview, “The U.S. government, from Secretary Azar to the president relied on the Centers for Disease Control to produce a test; they failed….CDC said they would handle it….What we have found out is that these leaders at the CDC lied to both the HHS secretary and, by extension, the president. And as a result the nation got weeks behind.”
[CDC Telebriefing: CDC Update on Novel Coronavirus, 2/12/2020]
Dr. Nancy Messonnier: Thank you for joining us. Today, I would like to provide a few updates on important developments over the last few days. First, I want to extend my condolences to the family of the American who died in China over the weekend. As far as we know, this is the first American to die from this new coronavirus. Though more than a thousand people in China have died. My sympathy and my thanks go to the people of China, for those who have lost loved ones and those who are on the front lines battling this virus. In China, they are taking aggressive measures just as we are in the United States. Since we briefed you last, there has been one new confirmed novel coronavirus infection detected in the United States. The new confirmed infection is an individual who returned from Wuhan and was quarantined at Marine Corps Air Station Miramar. This individual was on one of the last Department of State flights out of Wuhan, the epicenter of the outbreak in China.
Given the spread of the virus in Wuhan, it is not surprising to see a positive case among people who recently returned from there. That is in fact the reason they are being quarantined. Currently the person has mild illness but is hospitalized. This brings the total number of confirmed positives in the United States to 13. I want to clarify some of the reports that have been circulating about this case. Last Thursday when one of the planes from Wuhan landed at Miramar, a few people were sick and transported to local hospitals for further evaluation. These people were placed in isolation and samples were taken for testing. When running laboratory diagnostics for any disease, anywhere in the world, the ability to match the individual to the specimen is key, and is part of the normal procedures put in place to ensure that that matching is done correctly. But in this situation with this patient, it didn’t work correctly, and the patient was misidentified initially as negative. The issue was identified within 24 hours. The CDC tested the sample, the positive result was conveyed quickly to the local public health and CDC teams. The mishap was unfortunate, but we have corrected this from happening again in the future by adding additional quality control. And it’s really important to emphasize that during this time appropriate infection control precautions were taken around everyone, including around this patient who, again, is doing well.
Now I’d also like to update you on our diagnostic test kits. As you know, this is a dynamic, rapidly evolving situation, and our response continues to be based on the latest science. We continue to be flexible to meet the public health challenges that the virus presents, and clearly a success is the CDC rapid development of a diagnostic and rapid deployments to the states, which was clearly important to try to bring the testing closer to patients to avoid delays that have been inherent in sending samples to CDC. When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories. Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct. During a response like this, we know things may not always go as smoothly as we would like. We have multiple levels of quality control to detect issues just like this one. We’re looking into all of these issues to understand what went wrong, and to prevent these same things from happening in the future.
Before I take questions, I want to give you a couple more updates. Since the airport screening began in mid-January, CDC and its partners have screened more than 30,000 passengers from China. With the temporary restrictions on travel, we are seeing fewer and fewer travelers from China, especially from Hubei province. Passengers are being funneled through 11 airports, most of these people are coming from parts of mainland China outside of Hubei, show no symptoms and have not been assessed as high risk. Those who passed the screening continue on to their final destination where they self-monitor their health for 14 days in cooperation with their state and local health departments. We’re asking these people to limit their activities and stay home during that 14-day period. Our goal is to be as least restrictive as possible while ensuring the safety and health of all Americans. Since starting our travel restrictions and funneling through airports, we have not detected any cases among returning travelers from China.
Most of the U.S. cases were found before the travel restrictions were put in place among travelers who returned from Wuhan and later sought medical care for their illnesses. These cases were picked up by astute clinicians and reported to CDC. We are continually reassessing our recommendations around quarantine and self-monitoring and will continue to work with state and local public health departments to refine and improve this process. Most of the diseases in China, however, we can and should be prepared for this new virus to gain a foothold in the U.S. The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States but at some point, we are likely to see community spread in the U.S. Or other countries and this will trigger a change in our response strategy. This will require the effort of all levels of Government, the public health system and our communities as we face these challenges together. We are focusing now on preparing in other areas, including development of guidance for our health care practitioners, and planning for increased demand on our health care system. One important aspect of this is taking steps to make sure there are enough supplies and appropriate guidance to prevent the spread of the disease, especially among health care personnel caring for patients.
Only later did CDC attribute failure of the test to a flaw in “one of its components”. We still don’t know what component, or the nature of the flaw, or, for that matter, that it is correct. As of today, 3/23/2020, the CDC website reports that it is still testing its kit.
The forward-looking statements by Messonier on the importance of CDC in fighting outbreaks is overblown and not substantiated by evidence of their performance. The CDC’s webpage on the SARS outbreak boasts that they were essential during the outbreak and provided extensive testing. They did the same in the H1N1 outbreak.
They insisted that they be the only source of a test for Ebola- and tried also to corner the market on testing for Lyme disease.
Due to CDC’s self-centeredness and its gross incompetence, the US lags far – FAR behind other countries in testing.
Testing reduces the rate of spread as well as mortality because people who test positive can receive better care. Testing done at home would allow people to return to work. Our entire infrastructure for testing – with CDC at the center, validating results – wastes precious time and resources. And CDC’s test itself is not validated. PCR is the wrong tool – it takes too much time and requires validation by an agency incapable of producing a valid test.
There is even a test that can be conducted on-site for a COVID-19 diagnosis in 15 minutes by Biomedomics; it is thoroughly described in the Unbreaking Science companion video. (Not a Paid Endorsement). It could readily be used – it was used by China and other countries who have better control of COVID-19 rates.
The test requires a drop of blood – like a sugar test – and give results in 15 minutes.
It is simple to interpret, and people who test negative 1.5 weeks with three tests could send photos of their test to their doctors.
In spite of how trivially easy it is to create an accurate PCR test, it appears that CDC has forgotten how to do so. It is ludicrous to send CDC specimens so they can validate tests now that they have proven incompetent at developing a useful COVID-19 test. Local research hospitals have far more talent and creativity in diagnostic testing – as do commerical entities. They tend to test and validate their assays with science, like the Germans did. They had their test ready – and validated – January 16, 2020.
Many more details on the fiasco and CDC’s illegitimate and stalling responses are available in this powerpoint presentation (See link at the beginning of article for powerpoint)
Other questions remain: Does raw incompetence compute in this space? There can be no other plausible explanation. Or can there? Is there another reason? Would an errant test benefit CDC? Did someone put another flaw into the test intentionally? What possible reason – or reasons- could exist that CDC would want SARS-CoV-2 to take a foothold in the US? Either way, centralizing public health responsibility has proven to be a seroius threat to public health and to national security.
All of the discussion on the flaws in CDC’s test – which dominates the coverage by the press – eclipses the real flaw: that CDC had, in it hands, the information on primers and protocols for a test that was validated.
The culture of CDC primacy – making itself appear more relevant than it really is – and placing itself at the center of society for all issues on Public Health – have already cost us far too much. These delays were utterly unnecessary and preventable.
Those at the CDC who decided, for the rest of us, that the validated test from Germany was useless should be held accountable and forced to resign. There simply is no excuse for – and now clearly no need for centralization of public health “authority”. CDC does not know everything; it does not represent cutting edge understanding of key public health information. They have put the US population’s health at risk, at great cost (Read: IPAK Statement on CDC Diagnostics).
The CDC does not even produce reliable and useful information on influenza infection and death rates – an infection we have been diagnosing and tracking for over 100 years – by overestimating death by two orders of magnitude to to convince the public to accept the basically useless influenza vaccines.
Which brings us to another topic worth exploring in the near future: What possible reasons could lead allopathy to so suddenly become anti-antiviral? During the H1N1 outbreak, CDC repositioned 25% of the nation’s antivirals to fight the virus.
CDC is a regulatory agency, part of HHS, which is part of the Executive Branch of the US Government. The US Government should not – but does – have technology that it licenses (see technology available from CDC here) – including many in diagnostics for pathogens. That arrangement places it in competition with the private sector – and agency scientists should not be allowed use US taxpayer’s funds to develop “their own” test.CDC, and HHS, in fact, should not own anything: regardless, they do obviously own and license diagnostic kits, competing (unfairly) wih the private sector.
So what reason could there be for CDC to intentionally fail at testing? Fail at swift adoption of antivirals and therapeutics that are working for other nations? Who benefits from an unchecked outbreak? There is one reason that causes many I know to reevaluate the entire CDC testing fiasco: the COVID-19 vaccine – and, more importantly, its mandate. We’ll review that issue in Episode 2 of “Ending the Pandemic”.
Madison Area Lyme Support Group 