This is a very important memo from Howard Laitin to me in which he states his belief that
working together you and I can help get Israel to open its economy and society
Howard Laitin Torrance : California : United States
Harvard, Ph.D.(Economics; Public Health). National Defense University Graduate Program; U.S. Army Command and General Staff College; Career Officer Course; Lt. Col. USA (Retired).
Chief Scientist, Hughes Aircraft Company & Raytheon Corporation (Retired). Adjunct Professor of Engineering, USC. Clinical Associate Professor of Public Health, UCLA. Registered Professional Engineer (California).
Consultant/Advisor: Center for Strategic and International Studies; Hudson Institute; Institute for Defense Analyses; Rand Corporation; Government Accountability Office; Office of Management and Budget; Department of Defense; Department of Health and Human Services; Department of Transportation; US Treasury. Army Science Board; National Highway and Traffic Safety Administration; National Science Foundation. US Customs Service.; US Public Health Service.
Chairman Environmental Quality Programs: Governor Ronald Reagan, Governor Jerry Brown.
Ted,…. MEMO #1
it is imperative that Israel reopen its economy and reopen it’s society. Israel should adopt as its operating philosophy : 1. “we are going to open everything 100% as rapidly as possible. 2. We will work jointly with every organization and every establishment to develop the individualized plan that is economically and operationally feasible for them [and provides low risk to the public].
And I believe that working together you and I can help accomplish this objective.I strongly urge that the approach of air circulation enhancement plus simple, inexpensive, rapid reading test capabilities plus the immediate utilization and widespread administration of inexpensive, safe medications such as Ivermectin or hydroxychloroquine be utilized as a key to rapidly reopening society and restoring a robust economy.
I Will try to feed you appropriate information.
First is transmission
The last time the United States encountered an equivalent pandemic life continued at a exhilarating pace and, in spite of the pandemic, Woodstock and other mass gathering festivals were held (and celebrated for years as the demonstration of American exuberance).
There are certain keys that are well-known. Outdoor transmission is very unlikely. A comprehensive tracking study found that only one case in the 7000 that were studied was the result of an outdoor transmission. Contact with contaminated surfaces has also been ruled out as a significant vector. Remaining possible sources of infection include a cloud of droplets floating in the air; and an aerosol cloud floating in the air. Both of these are dissipated outdoors by slight wind currents and indoors by air scrubbers and other well-known ventilation and air cleaning procedures.. Thus, for indoor locations the secret is air scrubbing, and movement, etc. In other words make the indoors as close to the outdoors as possible. The technology for doing this is well understood and inexpensive.
Most studies indicate that most infections are the result of close, sustained [5 to 10 minutes] contact with an infected person who is at the stage where he/ she is shedding the virus. These people, whether they have obvious signs of infection or do not have obvious signs of infection, will test positive on numerous rapid tests that are nearly immediately available.
Then, one must find cooperative sectors in which to institute the programs. Hospitality which is a major producer in Israel seems to me to be a good candidate. Certain schools and possibly certain units of the IDF might be also considered
Lets do a scenario for hospitality. All passengers and the crew take a medication prophylactically. Then before boarding theirflight they are screened with a simple test utilizing saliva. These tests should cost under five dollars each and produce results in a few minutes and not requirie any submission to a laboratory, Then, on arrival in Israel they are again screened upon deplaning. This test would also betest to be used would also be a simple screening test, but a different one. Then during their stay in Israel they would maintain their prophylactic medication routine. All personnel at hotels, guides, etc would also be a on the same prophylactic routine.
There are two well-established medications both of which have a long history of safe usage. Both my son and my son-in-law recommend hydroxychloroquine. My son-in-law a who deals with confirmed Coved-19 patients has had 56 confirmed cases and has had 100% success. No hospitalizations. No deaths
NOW BACKGROUND MATERIALS FOR YOUR READING
1. TESTING
A. Israeli Hospital Trials Super-Quick Saliva Test for COVID-19 by Reuters and Algemeiner Staff
A newly-developed saliva test aims to determine in less than a second whether or not you are infected with the novel coronavirus, Israel‘s largest medical center said on Thursday.
Patients rinse their mouth with a saline wash and spit into a vial. This is then examined by a small spectral device that, in simple terms, shines light on the specimen and analyses the reaction to see if it is consistent with COVID-19.
With machine learning it gets more accurate over time.
Eli Schwartz of the Center for Geographic Medicine and Tropical Diseases at Sheba Medical Center, who is leading the trial, said it was easier to use than PCR swabs commonly used to detect COVID-19.
“So far we have very promising results in this new method which will be much more convenient and much cheaper,” he said.
The center said in an initial clinical trial involving hundreds of patients, the new artificial intelligence-based device identified evidence of the virus in the body at a 95% success rate.
Amos Panet, an expert in molecular virology at Jerusalem’s Hebrew University, said he would like to see more data and comparisons with existing tests before making a final judgment.
The amount of virus present in saliva increases as patients get sicker, he said, and a big challenge is to detect in “people who are borderline.”
“It will be a game changer only if we see validation of this technology against the current technology,” he said.
Sheba, located just outside Tel Aviv, has partnered with the device’s developer, Israeli firm Newsight Imaging, to bring the system to market.
The company said they are in the process of getting regulatory approval. Each test costs less than 25 cents and it expects the device will eventually cost less than $200
B. Israeli Scientist Creates 1-minute Corona Breathalyzer Test<
I have no way of knowing whether this Covid-19 breatht analyzing test, when perfected, will perform as touted in this video. But what I can say is that speaker is correct he refers to “physics” based tests being easier to standardize and apply to large numbers of people.
if anything even remotely like this test is developed, the use of the test coupled with other measures such as air scrubbers makes the opening of businesses and the opening of the schools without masks, without social distancing, etc eminently feasible.
Israel should adopt as its operating philosophy : 1. “we are going to open everything 100% as rapidly as possible. 2. We will work jointly with every organization and every establishment to develop the individualized plan that is economically and operationally feasible for them [and provides low risk to the public].
|
C FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing<
|
FDA NEWS RELEASE …. For Immediate Release: 8-20-20<
>
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.<
>
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.
Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.
This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection. While FDA has seen variable performance in tests using saliva, Yale School of Public Health submitted data with its EUA request from which the FDA determined that Yale’s test meets the criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19 infection.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
Related Information
******
D.. From Dr.Michael Mina: [These are a series of tweets Dr. Mina which I attempted to capture and put in sequence.. any failure is that of the editor not having sufficient skill to satisfactorily accomplish this objective.]
Terrific news that SalivaDirect gained @US_FDA approval today! A major step forward for lab based #COVID19 diagnostics.
SalivaDirect is a wonderful and hugely needed addition to the arsenal of laboratory based diagnostics. It will improve capacity to test in other CLIA labs too! It is however not a rapid test that’s going to be done at home with an answer in minutes. These are different. I’ll explain why this is good for DIAGNOSTICS but also why this is not widescale RAPID testing. Both are needed. Saliva use does not equal rapid testing.
If a test needs a lab, it will necessarily not be rapid and will hit limits in volume. Only a certain number of tests fit through a doorway each day and onto a robot. With the right technology, a lab based test can get to very high numbers…But it will necessarily not return a result in minutes (must travel to the lab) and the lab will hit its limits in terms of volume.So rapid tests are a whole different idea. It is distributed testing – with results back in minutes, on the spot. There are different kinds of tests.
Some rapid tests are true diagnostics – they need some healthcare involvement, including doctors prescription of some sort, and are going to hit high levels of sensitivity because they are for medical diagnostics.
The tests with diagnostic labels will usually be more $$ too because they can be reimbursed by insurance (at least in US).
There is another kind of rapid test, which we have been calling for. These are first and foremost for public health – and can be done at home…
Non diagnostic rapid tests might use saliva or will use frontal nose swabs. They will hopefully not have a full diagnostic claim because they will serve to indicate if someone may be transmitting virus, but will not be used by a doctor to diagnose. These are different.
For more info on those kinds of rapidtests, you can check out http://rapidtests.org (
[*******@SaadOmer3. Thanksfor reminding. By removing RNA extraction, SalivaDirect test can be made considerably cheaper than most lab based qPCR tests today. Likely <$5 vs $15-$50 in materials, making qPCR more accessible in low and middle income countries.]
First – why is this important for diagnostics?
First First though… what do I mean by diagnostics?
Diagnostics are what doctors use to know why someone is sick. They are a specific kind of test. Vs. a surveillance or public health test that indicates something.
A diagnostic that a doctor orders must be very good to do what it is meant to do – determine if someone is sick for a specific reason. So it needs to be high sensitivity and high specificity, there’s little wiggle room. This is different than a public health indicator test.
I won’t harp further on diagnostics. Why is the SalivaDirect a good step forward for DIAGNOSTICS?
Two main barriers have gotten in the way of diagnostics in this pandemic: Swabs/tubes/media for sample and importantly, RNA extraction kits that prepare the RNA for PCR test
The SalivaDirect uses saliva – abrogating need for a swab/tube/media. Simply spit in a plastic tube without any other buffer or diluent needed. Simple as that – but then it MUST GO TO A LAB (more later)
So removal of the need for a swab and transport media removes a crucial step that has plagued numerous testing efforts. While swabs haven’t really been too limiting lately, the choice between a deep nasopharyngeal swab and a more convenient front of nose swab is a tradeoff.
the deep nasopharyngeal swabs are difficult to perform – require a healthcare provider to do it, and are uncomfortable. The anterior nare (front nose) swabs are easier to self-perform, don’t hurt, but don’t catch as much virus as the deep nasopharyngeal swabs.
Use of saliva is a nice intermediate. It seems to catch potentially more virus than a self-collected anterior nasal swab but it’s up for debate still how well it does against a nasopharyngeal swab. Either way, it doesn’t require a swab/media, can be self collected, and works.
So to sum up point 1, SalivaDirect is an improvement by removing the need for a swab/tube and removed need for a healthcare worker performed nasophayrngeal swab – although self-collected frontal nose swabs have also already been approved.
Now on to why it is good for the lab
A major hurdle in lab diagnostics for COVID19 has been a step in the qPCR process called RNA extraction. The RNA extraction kits were one of the first lab items in March to become limiting. Never did the world expect the number of RNA extraction kits that would be needed…
The RNA extraction process not only has proven to be a bottleneck in terms of supplies, but also adds an extra step in the laboratory that is almost as, or more burdensome as the qPCR test itself… so removal of it would be welcomed…
The RNA extraction process not only has proven to be a bottleneck in terms of supplies, but also adds an extra step in the laboratory that is almost as, or more burdensome as the qPCR test itself… so removal of it would be welcomed…
To stop major outbreaks – we either need major behavioral change – seems unlikely – need to shutdown the economy again, vaccines (all of which problematic), or we need the federal government to approve and then mass produce simple at home #dailyquicktests
****
2. MEDICATIONS
A. Hydroxychloroquine
1. From HARVEY A. RISCH, MD, PHD , PROFESSOR OF EPIDEMIOLOGY, YALE SCHOOL OF PUBLIC HEALTH ….”The Key to Defeating COVID-19 Already Exists[ hydroxychloroquine]. We Need to Start Using It “
As professor of epidemiology at Yale School of Public Health, I have authored over 300 peer-reviewed publications and currently hold senior positions on the editorial boards of several leading journals. I am usually accustomed to advocating for positions within the mainstream of medicine, so have been flummoxed to find that, in the midst of a crisis, I am fighting for a treatment that the data fully support but which, for reasons having nothing to do with a correct understanding of the science, has been pushed to the sidelines.
As a result, tens of thousands of patients with COVID-19 are dying unnecessarily. Fortunately, the situation can be reversed easily and quickly.I am referring, of course, to the medication hydroxychloroquine. When this inexpensive oral medication is given very early in the course of illness, before the virus has had time to multiply beyond control, it has shown to be highly effective, especially when given in combination with the antibiotics azithromycin or doxycycline and the nutritional supplement zinc.
On May 27, I published an article in the American Journal of Epidemiology (AJE) entitled, “Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.” That article, published in the world’s leading epidemiology journal, analyzed five studies, demonstrating clear-cut and significant benefits to treated patients, plus other very large studies that showed the medication safety
2. Hydroxy Hysteria Reaching a Fever Pitch [Exerpts]
By Brian C. Joondeph, M.D. American Thinker 7-31-20 Ever since President Trump mentioned hydroxy as a possible therapeutic, the media have castigated it as worse than rat poison. They’ve criticized any use of it in a constant barrage of fear, telling everyone that this 60-year-old drug would kill anyone who dared tak 8-e it.
When Trump mentioned he was taking hydroxychloroquine as a preventative, Fox News’ Neil Cavuto told his audience, “I cannot stress enough. This will kill you.” Tell that to those Americans taking hydroxy to the tune of five million prescriptions written each year.
Hydroxy was FDA-approved in 1955 and is taken for lupus and rheumatoid arthritis. FDA approval means the approved drug is both efficacious and safe. All of a sudden, after 60 years, the FDA decided hydroxy is no longer safe because of, “serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure.” If it is so unsafe, why did the FDA not rescind its 60-year-old approval?
It is worth noting that diseases treated by hydroxy for the past half century can cause these problems as well. As can COVID, which if severe, can also cause death. So, the FDA deems it safe to treat those sick with lupus and autoimmune diseases with hydroxy but not those sick or hospitalized with COVID.Several days ago, a group of physicians called “America’s Frontline Doctors held a press conference in front of the U.S. Supreme Court building discussing the coronavirus and hydroxychloroquine. One physician in particular, Dr Stella Immanuel, gave an impassioned shout-out for hydroxy:
I’m here because I have personally treated over 350 patients with COVID. Patients that have diabetes, patients that have high blood pressure, patients that have asthma, old people … I think my oldest patient is 92 … 87-year old. And the result has been the same. I put them on hydroxychloroquine, I put them on zinc, I put them on Zithromax, and they’re all well.
All of you doctors that are waiting for data, if six months down the line you actually found out that this data shows that this medication works, how about your patients that have died? You want a double-blinded study where people are dying? It’s unethical. So guys, we don’t need to die. There is a cure.
Not content with censorship, the media attacked the messenger, Dr. Immanuel, slamming her religious views and some supposed previous comments on alien DNA. Before CNN makes fun of alien DNA ,they should note that Dr. Immanuel holds a Texas medical license in good standing with no disciplinary or malpractice actions against her.
Some studies say hydroxy doesn’t work, like giving hydroxy to patients too sick to benefit, already on a ventilator, as in the VA study. Other studies found safety concerns and were published in prestigious medical journals like The Lancet and The New England Journal of Medicine, only to be discovered to be bogus and retracted. Still other studies, as from the Henry Ford Health System noted that hydroxy cut the death rate in half.
This chart from the Association of American Physicians and Surgeons shows a much lower case fatality rate in countries where hydroxy is allowed and encouraged rather than banned or discouraged.
Dr. Fauci says all the ‘valid’ scientific data shows hydroxychloroquine isn’t effective in treating coronavirus.” Perhaps he missed the Henry Ford study. Or conveniently forgot last March when asked if he would prescribe hydroxy he said, “Yeah, of course, particularly if people have no other option.” What other options are there? A ventilator? The morgue?
The science isn’t settled as science rarely is. Coffee caused cancer until it was found beneficial in prolonging life. Butter was a killer until it became healthy. In the big scheme of risk versus benefit, hydroxy, in the opinion of this physician, falls on the benefit side. Ultimately, it’s about choice, that of the patient and their doctor.
Why then all the hysteria about hydroxy? One reason is that President Trump touted it. That’s enough reason to be against it. Other potential treatments h
ANECDOTAL DATAave been suggested for COVID, including Remdesivir, statins, and antacids. These were promoted by prominent institutions including Columbia University and Massachusetts General Hospital, but none of them have panned out as a successful treatment. And all have side effects, some serious.
Were proponents castigated and cancelled? Were Fox News anchors telling viewers that statins will kill you? Would these potential but failed treatments have been maligned by the media if Trump had suggested them rather than simply ignoring them when they didn’t pan out?
Brian C. Joondeph, M.D., is a Denver-based physician and freelance writer.
3.ANECDOTAL DATA [from the field]
Concerning Hydroxychloroquine .Everyone that I deal with says the secret of success is early use… yet all the negative reports that I’ve seen are based on relatively late use
My oldest granddaughter and her entire team were on a prophylactic regime of Hydroxychloroquine during their assignment to Africa. No one suffered from any side effects.
a. Encino CA Harvard Medical School MD; board certified in internal medicine and other specialties; UCLA internship and residency and now on the clinical faculty of UCLA; clinic director; in private practice including infectious diseases for more than 30 years has successfully used Hydroxychloroquine with more than 56 patients. He likens its use to a fire extinguisher and says it is effective very early in the game when symptoms first appear before the virus really gets a toe hold. [“So far in my clinical experience, I can tell you that Hydroxychloroquine/
b. Phenix AZ Tufts medical school MD; board-certified in anesthesiology and pain management; clinic manager has successfully used Hydroxychloroquine on two shared patients. Also tells me that all of his associates prescribe Hydroxychloroquine and would use it in their own families.
c, Torrance CA a local physician prescribed it to both of his elderly parents [ mother late 80s, father early 90s] who tested positive for Covid-19 just before both were taken to the hospital in serious condition. Although the expectations were that one or both would die-both survived and are now both well on the road to recovery. ironically, the mother was selected for a medical test but received the placebo. Otherwise except for Hydroxychloroquine she had no other medication. The physician at the hospital claimed that Hydroxychloroquine was ineffective. The son , in a major article ,claimed otherwise. If the report was to be utilized by CDC they would take the hospital position and chalk it up that it was “ineffective.”
d. Coronavirus at Texas Nursing Home – Hydroxychloroquine Treatment Saves All But 1 Patient …..
The Resort at Texas nursing home had an outbreak of coronavirus that infected 56 residents and 33 staff members. “Two of our residents had symptoms and that’s when we tested everybody,” said nursing home Executive Director Jan Piveral. 56 residents and 33 staff members were COVID-19 positive. “Our Goal was to make sure we could shelter them in place so we don’t spread it to other people,” Armstrong said. “Then also at the same time treat them so they would get better.”Dr. Robin Armstrong immediately administered hydroxychloroquine to the residents and staff members along with Zpac and Zinc. Only one nursing home patient died since the doctor prescribed the hydroxychloroquine. 55 made it.<
>
Armstrong says he knew residents who ended up in the hospital had a higher mortality rate. “Our goal was to keep them here and treat them with the medications we had available,” he said.
When Armstrong began administering Hydroxychloroquine to it was controversial but appeared promising.“If we didn’t make the decision quickly then we could potentially lose 15 to 20% of the residents which was not an option,” said the Doctor. Armstrong’s approach was to begin administering Hydroxychloroquine a Zpac and Zinc just as soon as a resident first started showing symptoms.The patients were being monitored daily. “We did EKGs on each of these patients to make sure they didn’t have the cardiac side effects that everyone talks about,” Armstrong said. “None of our patients did.”Armstrong doesn’t call the Hydroxychloroquine a cure and is aware of all the recent reports that say the drug shouldn’t be used to treat COVID-19.But he points out only one of the nursing homes COVID-19 patients has died.“Everyone who got on treatment who started on treatment is actually doing really well,” he said.<
>
e. Information from Monroe, New York
Since 3/15/20, my team has seen approximately 1354 patients in Monroe, New York with either
test proven or clinically suspected coronavirus infection. The majority of the patients were
treated with only supportive care. The patients with shortness of breath or who are in the high
risk category were treated with the above regimen (approximately 405 patients at this point)..
Of this group and the information provided to me by affiliated medical teams, we have had two
deaths, six hospitalizations for pneumonia, and four intubations (all extubated now). In addition,
I have not heard of any negative side effects other than approximately 10% of patients with
temporary nausea and diarrhea.
In sum, my urgent recommendation is to initiate treatment in the outpatient setting as soon
as possible in accordance with the above. Based on my direct experience, it prevents acute
respiratory distress syndrome (ARDS), prevents the need for hospitalization and saves lives.
Conclusion: TREAT AS EARLY AND AS AGGRESSIVELY AS POSSIBLE IN THE OUTPATIENT SETTING
1- hydroxychloroquine 200mg twice a day for 5 days
2- azithromycin 500mg once a day for five days
3- zinc sulfate 220mg once a day for five days
f. .MORE THAN 2,304 PHYSICIANS WHO ARE CURRENTLY SUCCESSFULLY TREATING PATIENTS INFECTED WITH THE COVID-19 REPORTED THEIR “ANECDOTAL EVIDENCE” OF THEIR SUCCESS WITH THEIR PATIENTS UTILIZING HYDROXYCHLOROQUINE
An international survey conducted by Sermo, a global health care polling company, of 6,227 physicians in 30 countries found that 37% of those treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.
The survey also found that the most commonly prescribed treatments are analgesics (56%), azithromycin (41%) and hydroxychloroquine (33%).
Azithromycin, known by the brand name Zithromax or Z-Pak, was rated the second-most effective therapy at 32%, followed by “nothing,” analgesics (including acetaminophen), anti-HIV drugs and cough medicine.
Hydroxychloroquine, which is sold under the brand name Plaquenil, was prescribed mainly in the United States for the most severe cases, but not so in other countries.
“Outside the U.S., hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the U.S. it was most commonly used for high risk diagnosed patients,” the survey found.
The 30 nations surveyed included those in Europe, Asia, North America and South America, as well as Australia. No incentives were provided to participate in the poll, conducted March 25-27, according to Sermo.
Hydroxychloroquine usage was most widespread in Spain, where 72% of physicians surveyed said they had prescribed it, followed by Italy at 49%, and least popular in Japan, where 7% had used it to treat COVID-19.
The poll found 23% of U.S. medical professionals had prescribed the drug, which has been FDA-approved for malaria, lupus and rheumatoid arthritis.
Quoting Sermo CEO Peter Kirk [ which would be direct counter to Dr. Bright’s insistence that these medications be only provided to hospitalized patients] “Physicians should have more of a voice in how we deal with this pandemic and be able to quickly share information with one another and the world,” he said. “With censorship of the media and the medical community in some countries, along with biased and poorly designed studies, solutions to the pandemic are being delayed.”
4. Hydroxychloroquine…article from tablet magazine for your intensive review. This is a very long read but well worth your time and energy. It is the most comprehensive and most balanced review of the Hydroxychloroquine situation that I have encountered.
by Emily Benedek The Tablet 8-14-20
https://www.tabletmag.com/
Early in the coronavirus pandemic, a survey of the world’s frontline physicians showed hydroxychloroquine to be the drug they considered the most effective at treating COVID-19 patients. That was in early April, shortly after a French study showed it was safe and effective in lowering the virus count, at times in combination with azithromycin. Next we were told hydroxychloroquine was likely ineffective, and also dangerous, and that that French study was flawed and the scientist behind it worthy of mockery. More studies followed, with contradictory results, and then out came what was hailed by some as a definitive study of 96,000 patients showing the drug was most certainly dangerous and ineffective, and indeed that it killed 30% more people than those who didn’t take it. Within days, that study was retracted, with the editor of one of the two most respected medical journals in the Western world conceding it was “a monumental fraud.” And on it went.
Not only are lay people confused; professionals are. All that seems certain is that there is something disturbing going on in our science, and that if and when the “perfect study” were to ever come along, many won’t know what to believe.
We live in a culture that has uncritically accepted that every domain of life is political, and that even things we think are not political are so, that all human enterprises are merely power struggles, that even the idea of “truth” is a fantasy, and really a matter of imposing one’s view on others. For a while, some held out hope that science remained an exception to this. That scientists would not bring their personal political biases into their science, and they would not be mobbed if what they said was unwelcome to one faction or another. But the sordid 2020 drama of hydroxychloroquine—which saw scientists routinely attacked for critically evaluating evidence and coming to politically inconvenient conclusions—has, for many, killed those hopes.
Phase 1 of the pandemic saw the near collapse of the credible authority of much of our public health officialdom at the highest levels, led by the exposure of the corruption of the World Health Organization. The crisis was deepened by the numerous reversals on recommendations, which led to the growing belief that too many officials were interpreting, bending, or speaking about the science relevant to the pandemic in a politicized way. Phase 2 is equally dangerous, for it shows that politicization has started to penetrate the peer review process, and how studies are reported in scientific journals, and of course in the press.
Those who have their doubts about hydroxychloroquine rightly point out that the public is scared, and we are longing for a magical potion to rescue us. The history of plagues is rife with such potions and the charlatans who sold them were well documented in Daniel Defoe’s Journal of a Plague Year. A pandemic is not a remedy for the innate tendency toward wishful thinking.
What is unique about the hydroxychloroquine discussion is that it is a story of “unwishful thinking”—to coin a term for the perverse hope that some good outcome that most sane people would earnestly desire, will never come to pass. It’s about how, in the midst of a pandemic, thousands started earnestly hoping—before the science was really in—that a drug, one that might save lives at a comparatively low cost, would not actually do so. Reasonably good studies were depicted as sloppy work, fatally flawed. Many have excelled in making counterfeit bills that look real, but few have excelled at making real bills look counterfeit. As such, as we sort this out, we shall observe not only some “tricks” about how to make bad studies look like good ones, but also how to make good studies look like bad ones. And why should anyone facing a pandemic wish to discredit potentially lifesaving medications? Well, in fact, this ability can come in very handy in this midst of a plague, when many medications and vaccines are competing to Save the World—and for the billions of dollars that will go along with that.
So this story is twofold. It’s about the discussion that unfolded (and is still unfolding) around hydroxychloroquine, but if you’re here for a definitive answer to a narrow question about one specific drug (“does hydroxychloroquine work?”), you will be disappointed. Because what our tale is really concerned with is the perilous state of vulnerability of our scientific discourse, models, and institutions—which is arguably a much bigger, and more urgent problem, since there are other drugs that must be tested for safety and effectiveness (most complex illnesses like COVID-19 often require a group of medications) as well as vaccines, which would be slated to be given to billions of people. “This misbegotten episode regarding hydroxychloroquine will be studied by sociologists of medicine as a classic example of how extra-scientific factors overrode clear-cut medical evidence,” Yale professor of epidemiology Harvey A. Risch recently argued. Why not start studying it now?
This inquiry concerns a molecule that has had so many accusations directed against it that it now has more than a whiff of scandal. As such, it might be thought of as a miniature of those eponymous 18th-century novels of reputation named after a single protagonist, such as Tom Jones, or Moll Flanders, where the hero’s good name is besmirched early in life and they must spend the rest of the story hoping to retrieve it. These adventures are really every bit as much about the societies that surround the protagonist who, though no angel, has some redeeming features, and the writer has invented these imperfect, roguish heroes for the pleasure of seeing them abused and tormented chapter after chapter, often falsely accused. We are held in suspense, watching the hero’s rises and falls, waiting to see whether fair play wins out in the end—or whether he or she is a scoundrel after all, who has pulled the wool over our eyes. So they are also morality tales.
A morality tale must have a central character that can arouse some of our sympathy. When the lead character’s name is the unapproachable and unpronounceable “C18H26C1N3O,” we are off to a bad start. That it often goes by “hydroxychloroquine sulfate” doesn’t help. So, like those English men and women of a certain era with embarrassing names who hid them behind initials or contemporaries so well known to their audiences that all one needs are a few letters to recognize them—like FDR or OBL or DMX—we shall call our protagonist simply: HCQ.
HCQ was first synthesized in 1946, but came from a distinguished European line. Its esteemed forebear, “quinine,” made from cinchona bark, had been used to treat malaria since at least the 1600s. In the 1700s, the Scottish physician and chemist William Cullen, an important Enlightenment figure, friend of David Hume, and physician to both Hume and the Scottish king, published his theory of how quinine cured malaria. Another physician, Cullen’s near contemporary, Samuel Hahnemann, translated Cullen’s medical text, and decided to try some quinine himself, and found it gave him malaria-type symptoms. This so intrigued him, that it launched him on a new theory of his own—that diseases can sometimes be cured by substances that, if given to healthy individuals, give symptoms that are similar to the disease, but if given to people with the disease, they for some reason get better, such that “like cures like.” Thereby, homeopathy was born, an approach that continues to be widely used in Europe and is considered a sign of insanity by many Western physicians—mature skeptics who prefer to champion effective and safe medications, like opioids.
For 300 years, quinine, which is not rare—it is in tonic water, for instance—was the only known remedy for malaria, albeit an imperfect one. In 1934, German chemists at Bayer synthesized chloroquine in the lab, and during World War II, that drug was widely used by American forces, and found more effective than quinine, for both preventing the disease, and for its treatment. Chloroquine was used widely until the 1960s, when malaria—Plasmodium falciparum—cleverly had become resistant to it. But malaria couldn’t resist HCQ, which is nothing but chloroquine with a slight modification of its chemical structure, an added hydroxyl group. HCQ was approved for use in 1955, and found to be both more effective and less toxic than chloroquine, especially when taken for longer periods. As time passed, both chloroquine and HCQ were found to be helpful in treating autoimmune diseases like lupus and rheumatoid arthritis.
Early in the pandemic, in February and March, I was in Italy, where the death rate from corona (as it was then called) was astronomical, especially in the elderly and in frontline medical workers who had sustained contact with it (in what turned out to be infected hospitals), so I paid a lot of attention to what the Italian physicians and nurses and respiratory techs were doing for patients, and to protect themselves. Stories emerged that often they, and the Chinese frontline physicians and health care workers, were treating corona patients with HCQ, hoping it would help, and similarly hoping that by taking it prophylactically, it would stop them from getting sick. But why?
While the Chinese Communist Party and government were engaged early in the pandemic in a well-documented deception of the naive West—withholding information about the virus, and even banning their physicians from publishing research on the corona outbreak—behind the scenes many brave Chinese physicians were nonetheless communicating with Western colleagues. Wuhan was the epicenter, and the Chinese physicians at the People’s Hospital of Wuhan University told their Western counterparts that they got the idea of using HCQ because none of the 178 patients they had admitted for COVID-19 had lupus—a surprise, since lupus is an immune disease, and some thought it might have made these patients especially vulnerable. They wondered why this might be, and whether HCQ, which these patients had been taking for this preexisting condition, might in some way be protecting them against COVID-19.
Even in an age smitten by the idea that “Big Data Is Our Savior,” many of medicine’s greatest discoveries begin with precisely these kinds of chance observations, made by perspicacious frontline physicians looking at patients, and not from data sets or models, which can often be so abstract, that they generate only exalted nonsense. The question was: Could one extrapolate from these few patients—who might have been protected so far—to others?
A study in 10 Chinese hospitals was initiated, beginning as early as January 2020. When they found that 100 Chinese patients did better on chloroquine than controls, a conference was held on the subject on Feb. 15, in China. The preliminary results were published as a letter to an English-language journal, claiming they found the drug was effective against COVID-19-associated pneumonia. Chloroquine was included in the guidelines for the treatment of COVID-19 issued by the National Health Commission of the People’s Republic of China. By Feb. 23, seven Chinese studies of chloroquine or HCQ and COVID-19 had been added to the Chinese Clinical Trial Registry.
There was another reason studies were necessary. HCQ, though less toxic than chloroquine, can be dangerous in overdose, and for some people causes fatal heart arrhythmias, and it can cause retinal problems and blindness with long-term use (after 10 years of daily use, in 1% of patients), hearing loss, and even psychosis. Luckily, having been around so long, physicians had come to understand it very well, knew its dangers, how to screen for the approximately 1% of people who were vulnerable to these side effects, and also what drugs it interacted with that might trigger problems (such as antidepressants). And so, despite all of that, it had been considered safe enough—if patients were properly screened and monitored by physicians or trained health care providers, and it was taken in the right amounts for the proper period of time—to be used throughout the world. They were still careful: COVID patients were poorly understood and being administered many new combinations of medications; rather than just giving HCQ and hoping for the best, scientists began carefully documenting their observations.
By March, there was evidence from China, published in Nature, that showed HCQ blocked not only malaria but also the COVID-19 virus in a test tube. The study showed that HCQ was effective at inhibiting COVID infections when the scientists put cells (stand-ins for our own) in culture, in a petri dish, then added the COVID-19 virus, and watched what happened. Compelling photos showed how the drug inhibited the development of COVID-19 infections in the cells, making it a potent “antiviral.” It also decreased inflammation, which wasn’t that big of a surprise since this property was the reason HCQ was used to treat autoimmune diseases like lupus and rheumatoid arthritis, where the body’s inflammatory processes get out of control and attack its own cells. It was already clear by March that COVID-19 causes a wild autoimmune response in patients—the “cytokine storm”—which was often what killed them. But HCQ blocked cytokines, and moreover, it didn’t damage the cells in the process.
The lab scientists writing in Nature concluded that HCQ had three things going for it: It seemed safe for the cells (at least in the short term), was a promising antiviral against SARS-CoV-2 virus, and an anti-inflammatory compound that had potential for treating these patients. (It was soon learned that COVID-19 causes thrombosis or clots, which lead to stroke, and that HCQ also helped prevent these.)
Then on March 9, there was another Chinese study, published in Clinical Infectious Disease, which showed that HCQ was more effective in inhibiting the COVID virus in the test tube than chloroquine.
Did this mean the drug would cure COVID?
No, and the study wasn’t designed to demonstrate that. These tests done in the labs were what are called “proof of concept” studies: Preliminary studies designed to see if the “concept” that HCQ is an antiviral has any merit. To prove the drug could cure COVID would require studies in human beings, which followed patients for significant periods until they were better, or died, or left with aftereffects of the infection. Especially influential in much of the world in the early days (if not the U.S., which often, focuses, it seems, mostly on studies from the Anglosphere) were studies commissioned by the French government and led by the microbiologist, physician, and professor of infectious disease and virology, Didier Raoult, from l’Institut hospitalo-universitaire (IHU), which he directs in Marseille, and which had assembled one of the largest datasets in Europe.
Raoult is the most highly cited microbiologist in Europe, recognized for having identified 468 novel species of bacteria, most in humans, and for his team having discovered the largest virus ever documented at the time (so large it had been mistaken for an intracellular bacterium). He has boldly asserted that viruses—which had been classified as nonliving—are alive. He has published over 2,000 papers, many of them through the IHU, with him as a contributing or lead author. He has been given major awards, the French Legion d’honneur, and perhaps the most important one for a microbiologist, having a bacteria genus, “Raoutella,” named in his honor.
Raoult is a fascinating, eccentric, theatrical figure. He couldn’t be more colorful—a maverick who delights in opposing conventional thinking, his peers, and followership in science. He has hair to his shoulders, a long, pointed beard, and looks like a medieval knight in a lab coat. He loves a fight. At 68 years of age, he rides a Harley to work. He still treats patients. He sees himself as more like a philosopher or anthropologist than
[Message clipped] View entire message
Attachments area<
Preview YouTube video An Introduction to COVID-19 Tests
<
>
An Introduction to COVID-19 Tests
Preview YouTube video Why Lupus Patients May Hold The Key To Whether Hydroxychloroquine Could Work – Part 2
<
>
Why Lupus Patients May Hold The Key To Whether Hydroxychloroquine Could Work – Part 2
This is from today’s Globes on the economic consequences of Israel’s lockdown:
“Israel’s economy contracted at 28.7% in Q2
The Covid-19 crisis has caused the worst quarterly fall in GDP since the establishment of the State, the Central Bureau of Statistics has reported.
Guy Ben Simon
Benjamin Netanyahu and Israel Katz
Israel’s GDP contracted by 28.7%, on an annualized basis, in the second quarter of 2020, according to the initial estimate of the Central Bureau of Statistics, following a 6.8% contraction in the first quarter due to the Covid-19 crisis. The second quarter figure is the worst quarterly fall in GDP since the establishment of the State in 1948.
After seasonal adjustments, the Central Bureau of Statistics estimates that the Israeli economy has regressed to the same level as the fourth quarter of 2016. The dire statistics are due to the draconian restrictions introduced by the government in efforts to halt the spread of the coronavirus.
In the first half of 2020, the Israeli economy shrank by 10.1% on an annualized basis after growing 3.4% in the second half of 2019.
Per capita private consumption fell by 44.2% in the second quarter of 2020 and business output fell by 33.4%.”
Great ideas except for forcing prophylactic medicine on people for weeks. There may be drug interactions, unexpected side efects, etc.