Saturday, July 24, 2021

A Plea to Add EARLY Treatment to the Arsenal to Combat COVID-19.

 Copyright 2021 Robert Clark


Did WHO wipe from its web site a positive ivermectin report for safety?


 It was discussed on some online forums that WHO on it’s web site lauded ivermectin for its safety and effectiveness for treating parasitic disease:


Mass treatment with ivermectin: an underutilized public health strategy

https://web.archive.org/web/20141022190240/https://www.who.int/bulletin/volumes/82/8/editorial30804html/en/


 However, when I went to the link on the WHO site recently, that page is no longer there. Note the link I gave above is the one from the archive.org site, a site that archives previous web pages.


 The original link on the WHO site was:

https://www.who.int/bulletin/volumes/82/8/editorial30804html/en/


 If you go to that link now though you’ll get an error message that WHO has been revamping its site since 2020 and some pages have been moved. However, I used the search function on the WHO site and that page no longer turns up.


 So WHO acknowledges IVM’s safety for wide spread use. Then for a global epidemic it makes no logical sense to not allow its use under a doctors care, at least under an emergency use authorization.


 Here’s a stunning fact when you think about it: 


For COVID, IF your case is going to require hospitalization it will happen on average within 7 days of symptoms appearing.

Then IF a proposed medication really is successful for EARLY treatment of COVID-19, we will have evidence of that within days, indicated by the reduction of hospitalizations.


 To me that is a stunning fact, if any of these proposed medications really is effective for EARLY treatment, then if they had been used wide-spread for EARLY treatment in the U.S. or other countries we would have known within days that they had indeed been successful. We would not have had to suffer through the pandemic for 18 months. It’s extent could have been radically cut within just days.


 This shows why the single-minded focus of relying on RCT’s is severely misguided in the midst of a pandemic. RCT’s take 3 months or more to complete. That’s too long during a pandemic undergoing exponential growth.


 WHO and other public health agencies are not considering this fact in their risk-benefit analysis, especially for repurposed drugs with well-known side-effect profiles: the risk is small but the benefits are profoundly important and could be confirmed within just days.


 Here’s another way of seeing this: suppose we just now instituted a national treatment guideline that EVERYONE be giving IVM or some other proposed drug for EARLY treatment on first signs of symptoms. And suppose then within days we saw a drop in hospitalizations by 80%, i.e., by 1/5th, across the board, for every city and state, and for every race and socio-economic group we saw this drop.


Then proponents of RCT’s would still say it wasn’t real because it wasn’t conducted under the guise of an RCT.


 Note this is not just idle speculation. What we have seen in India may be an indication of such a rapid drop in cases and fatalities when IVM is put in wide spread use. 


COVID-19 CASES PLUMMET IN INDIA AS THEY DISTRIBUTE IVERMECTIN AND HYDROXYCHLOROQUINE

https://www.bitchute.com/video/j5X8oRUYbyHu/


 Note now the Indian variant that was spreading rapidly then IS the delta variant predominant in the UK, Israel and building now in the U.S.


 There was skepticism expressed by some that the effect in India could not be due to IVM because the drop occurred so rapidly after IVM being put in wide-spread use.


 But that’s the ENTIRE point of the matter: since IF for a particular case COVID is to progress to the hospitalization stage, it will happen within days. Then if a medication can greatly cut this risk by EARLY treatment, its effectiveness will also be seen within just days.


 Note too that such medications in their antiviral role if they really are effective as EARLY treatments quite likely will also be effective for prophylaxis. And that has indeed been seen to be the case for IVM. See for example this interview with a doctor actually treating patients with IVM in India:


Choosing and using ivermectin for covid-19 in India.

https://medicalupdateonline.com/2021/05/choosing-and-using-ivermectin-for-covid-19-in-india/


 So imagine such a drug also being used wide-scale in a country for prophylaxis, and it cutting transmission also by, say, 80%, i.e., by 1/5th.


 Then both these effects together prophylaxis and treatment will cut hospitalizations and fatalities by a factor of 1/25. This is now getting into the range of what vaccines can do, cutting severe cases and fatalities by double digits.


 Since the effect can be seen so rapidly, to test it this doesn’t have to be put in effect across an entire country. Just put it in effect in some city of some size, for both treatment and prophylaxis.


 I said WHO had earlier acknowledged ivermectins safety for mass treatment. But part of the reason it won’t grant its use for COVID treatment is the claim that not enough evidence supports its effectiveness. I have made this challenge to people I’ve corresponded with to perform their own judgement on this issue. The PubMed site has a listing of peer-reviewed published papers. Searching on there turns up literally dozens of published reports positive on ivermectins effectiveness:


https://pubmed.ncbi.nlm.nih.gov/?term=%28%28Ivermectin+COVID-19%29%29+AND+LitCTREATMENT%5Bfilter%5D&size=200


 As of now there are 210 reports listed under this search. That’s quite a lot of papers to review. So I’ve challenged anyone to pick any 10 at random. Here’s a random number generator page: random.org. Set the max range of numbers to pick from at 210. Use the generator 10 times to come up with 10 numbers at random from 1 to 210 and select those papers to review. Count now how many papers are positive, negative, and neutral. You’ll find the reports are overwhelmingly positive for ivermectins usefulness.


 It is simply unreasonable to suppose all those reports are finding positive effects just by coincidence.




  Robert Clark

Monday, June 21, 2021

SSME based SSTO’s. UPDATED, 6/28/2021 - Extension to the Delta IV Heavy

 Copyright 2021 Robert Clark


 The SSME makes possible *practical* SSTO’s, that is, with significant payloads. Need to use known lightweight materials, such as carbon fiber. As discussed in the blog post,


DARPA's Spaceplane: an X-33 version, Page 2

https://exoscientist.blogspot.com/2018/06/darpas-spaceplane-x-33-version-page-2.html 


some ultra high strength metals would also work:



 The standard aluminum the Delta IV used for its propellant tanks had about a 25 to 1 propellant to tank mass ratio. At 200 ton propellant mass, this gives a tank mass of 8 tons. So using light weight materials we can get this down to 4 tons.


 To estimate payload possible we need the required delta-v to low Earth orbit(LEO). Various estimates are given for this depending on altitude and orbital inclination. I’ll use the estimate give in this report of 9,000 m/s:


Towards Reusable Launchers - A Widening Perspective.

https://www.esa.int/esapub/bulletin/bullet87/pfeffe87.htm


 The Delta IV launch vehicle used the low cost, RS-68, an engine designed for low cost, but only at mid level performance. But for an SSTO you need both high performance engines and weight optimized structures. So we’ll replace the RS-68 with two SSME’s. The two SSME’s will have about the same mass as the RS-68 with slightly more thrust. But most importantly they have a much better vacuum Isp at 452.3 s compared to 412 s.


 The dry mass of the Delta IV first stage is about 26 tons. By light weighting the tank, we cut 4 tons from the tank mass to bring the dry mass to 22 tons. Then we can get a payload of 8 tons to orbit. By the rocket equation:


452.3*9.81ln(1 + 200/(22 + 8.2)) = 9,012 m/s.


 The Delta-IV TSTO, with no side boosters, has about the same payload to LEO using a Centaur upper stage:


https://en.m.wikipedia.org/wiki/Delta_IV#RS-68A_booster_engine_upgrade


The higher Isp of the SSME’s explains why the SSTO can match the performance of the TSTO to LEO.


 It is true that most launches now are for satellites actually to go to GEO, geosynchronous orbit. For this you can use the current Centaur upper stage. But firstly the use of the Centaur would allow higher payload to LEO than the current TSTO. The Centaur has about a 21 ton propellant load and 2 ton dry mass for a 23 ton gross mass with an Isp of 462 s. Then the TSTO could now get 21 tons to LEO:

452.3*9.81ln(1 + 200/(22 + 23 + 21.5)) + 462*9.81ln(1 + 21/(2 + 21.5)) = 9,050 m/s. 


 This is well above the 8 tons or so of the current TSTO version and is close to the payload of the Falcon 9 full thrust version.


 This TSTO does get more than the SSTO, but in point of fact you don’t need the maximal payload for most launches, so why use the upper stage if it is unneeded? 


 The additional delta-v required to GEO is about 3,800 m/s. Then a total of 12,800 m/s would be required to get the payload to GEO. This TSTO version could get 6 tons to GEO:


452.3*9.81ln(1 + 200/(22 + 23 + 6)) + 462*9.81ln(1 + 21/(2 + 6)) = 12,900 m/s. 


 This is multiple times higher than the current version:


http://spacelaunchreport.com/delta4.html#config


However, the SSME’s are expensive engines. To get the full usefulness of an SSTO you really need reusability. In point of fact by using lightweight thermal protection and landing legs, and lightweight wings or propellant storage for final approach, the additional mass for reusability can be less than 10% of the landed mass. So the SSTO would still get significant mass to LEO.


 Reusables do get their most usefulness at high launch rates. Then to serve various markets we would also want a smaller vehicle than this SSTO. We could get this by cutting down the tank size and using a single SSME: 


 We’ll cut down the propellant size to 150 tons, 3/4ths the usual size, and again we’ll use light-weighting on the tank of the Delta IV first stage. Subtracting off the 8 tons for the standard tank the dry mass is 18 tons. The tank mass at 3/4ths size would be 6 tons. But we’re lightweighting it so it’ll be 3 tons. That brings the dry mass to 21 tons.


 But the SSME at 3.2 tons is also a lighter engine than the RS-68, at 6.6 tons. So we’ll subtract off an additional 3.4 tons from the dry mass to bring it to 17.6 tons. There will be additional reductions in the dry mass due to smaller thrust structure for the lower thrust of the single SSME, and smaller insulation and wiring for the smaller vehicle, but not as large as the other reductions. 

 So for the first estimate take the dry mass as 17.6 tons. Then we can get 5 tons to LEO with this smaller SSTO:


452.3*9.81ln(1 + 150/(17.6 + 5)) = 9,020 m/s.


 Since less than 10% would be needed for reusability we can still get ca. 3 tons to LEO as a reusable SSTO.


  


   Robert Clark


UPDATED, 6/28/2021.

 The advantage of using high performance engines and lightweight tanks is not just for getting a SSTO. As mentioned above using this, the two-stage-to-orbit(TSTO) Delta IV can double its LEO payload to ca. 20 tons to match that of the Falcon 9 Full Thrust. Its payload capacity to the lucrative GEO satellite market would also match that of the Falcon 9 FT.


 ULA could then be competitive with SpaceX for the largest current market for commercial launches. Note that ULA could also match SpaceX in it's partially reusable approach of returning only the first stage. ULA head Tory Bruno has said the SpaceX approach of boosting back the first stage to the launch site requires too much fuel, and loses too much payload.


 Instead what ULA has proposed doing is returning the engine package only, catching it in midair on return by parachute. The rest of the first stage would be thrown away. This is a kludge, an inelegant solution just to get by. A kludge never provides a long lasting solution. The Space Shuttle was a kludge, which explains why it never reached its goal of fast and low cost reusability. However, by increasing the Delta IV's payload capacity in the described manner, ULA can also boost back to the launch site and match SpaceX in reusable payload capacity.


 The startling increase in payload would also apply to the Delta IV Heavy, with the addition of cross-feed fueling. This is where for a parallel staged vehicle the fuel for the central core is taking from the side boosters during the parallel burn portion of the flight. This allows the central core to be fully fueled when the side boosters are jettisoned.


55th International Astronautical Congress 2004 - Vancouver, Canada 

1 IAC-04-V.4.03 

DELTA IV LAUNCH VEHICLE GROWTH OPTIONS TO SUPPORT NASA’S SPACE EXPLORATION VISION

https://www.ulalaunch.com/docs/default-source/evolution/delta-iv-launch-vehicle-growth-options-to-support-nasas-space-exploration-vision.pdf

 We'll use the rocket equation to again estimate the payload possible for the Delta IV Heavy. Because of how cross-feed fueling works, the calculation works as if the it were a three stage vehicle with the fuel only being from the side-boosters during the "first stage":

452.3*9.81ln(1 + 400/(44 + 220 + 23 + 68)) + 452.3*9.81ln(1 + 200/(22 + 23 + 68)) +462*9.81ln(1 + 21/(2 + 68)) = 9,060 m/s.

 This payload of 68 tons nearly triples the payload of the current version of the Delta IV Heavy, and now matches the payload of the Falcon Heavy.


 This is still using the expensive SSME's however. But the point of the matter is this is doable for the current engine RS-68 used on the Delta IV as well if given altitude compensating nozzles.


 There are various means of adding altitude compensating nozzles to existing engines. They could be like the RL-10B with extendible nozzles, or flexible, expandable nozzles, or mechanically moving "petal" arrangements as with variable area nozzles on jet engines, or several other ways. 








 This last is interesting in that this method of achieving variable area nozzles has been in existence since the 70's. As a total WAG it might improve the performance for jets by, say, 10%. But for rockets using variable nozzles could improve performance by 100% or more and it still has not been used for rockets. 


 In such a way, a midlevel performance engine such as the RS-68 could be upgraded to achieve comparable performance of the high performance SSME's. I won't offer a calculation here using the rocket equation for this case. The reason is while such estimates frequently take the vacuum Isp for a fixed nozzle engine, this may or not be accurate for the case of an altitude compensating nozzle. On the one hand you can give the RS-68 a higher vacuum Isp than SSME, even at 470+ s, but the higher chamber pressure of the SSME, suggests it should have better performance at ground level than the RS-68 given alt.comp.  


 The calculation of the delta-v possible through altitude compensation is one that should be made by the launch companies.


Regular Manned Lunar Flights.

 The use of the higher performance engines gives us the capability of SSTO's with the Delta IV and also heavy lift with the Delta IV Heavy, with payload comparable to the first planned version of the SLS at ca. 70 tons. With this we have the possibility of routine manned flights to the Moon and beyond. Robert Zubrin has written a proposal for a low cost architecture for setting up a Moon base with regular flights to the Moon. Remarkable all it would need beyond the current capability is a reusable lunar lander.

 In the Zubrin proposal it would take only 3 flights of the Falcon Heavy and one flight of a manned Falcon 9 to set up the manned lunar base:


Op-ed | Moon Direct: How to build a moonbase in four years.

by Robert Zubrin — March 30, 2018

https://spacenews.com/op-ed-moon-direct-how-to-build-a-moonbase-in-four-years/


 But with the extra capabilities of the Delta IV Heavy, the three Falcon Heavy launches could be replaced by three launches of the Delta IV Heavy.


 Recall I said Zubrins plan only needed a lunar lander. ULA is planning the upper stage of its upcoming Vulcan lander, the Centaur V, to have in-space reusability. Then this upper stage could also be used as a reusable lunar lander. See discussion here:


Robust Lunar Exploration Using an Efficient Lunar

Lander Derived from Existing Upper Stages

AIAA 2009-6566

Bernard F. Kutter et al.

https://www.ulalaunch.com/docs/default-source/exploration/dual-thrust-axis-lander-(dtal)-2009.pdf



 In regards to adapting the Centaur V or a currently in use Centaur to a horizontal landing lunar lander, I advise the landing rockets be just pressure-fed thrusters fueled from the regular tanks of the hydrolox tanks of the Centaur.


Saturday, May 15, 2021

Possible effects of the COVID-19 vaccine on pregnancy and fertility. Part I.

 Copyright 2021 Robert Clark


I.)Maternal Fevers and birth defects.

 It is dismaying that the CDC has not been made clear the extent of the fevers that arise after the COVID vaccine shot. The CDC has put on its web site that fever can result after the shot but it has not emphasized the high prevalence: 15% to 30%, or perhaps as high as 50% for women is high prevalence.

 I think the CDC just putting that fevers can arise on its web site has not made this extent commonly known. Even if doctors or average citizens have heard the vaccine particularly the 2nd shot can cause a fever they would not be aware of its prevalence, or that the flu-like symptoms that arise can be so severe as to wipe you out, to the extent you can't go to work the next day.

 Most people would think it's just like the flu-vaccine. No, the flu-vaccine does not require hospitals to stagger their vaccination times for their staff to insure not too many people get knocked out on the same day.

 My guess is few doctors are aware the prevalence of fevers is as high as it is after the 2nd shot of the COVID vaccine. I certainly don't believe most OB-GYN's are aware of it. But that's where the problem comes in: maternal fevers in pregnancy are strongly associated with an increased chance of birth defects.

 I'm suggesting because of the potential danger of birth defects that can arise from these fevers when they occur in the pregnant mother, every time any health official comes on TV, every time any health agency puts out any update of any nature on COVID-19, every time any newspaper, TV news show, news web site, social media company says anything at all about COVID-19 or its vaccine, it should be accompanied by an advisory that pregnant mothers experiencing a fever after taking the vaccine should take it very seriously because of the potential of causing birth defects and so it should be reported both to their OB-GYN and to the CDC.

 In short, maternal fevers in the 1st trimester are linked to an increased chance of a very serious form of birth defect known as neural tube defect. These include spina bifida, anencephaly, and encephalocele.

 The naturally occurring fevers in the 1st trimester are at about 68%. But judging by the number of fevers seen in the COVID vaccine trials, there would be an additional ~15% vaccine caused fevers. So if you add the 15% COVID vaccine fevers to the number of natural fevers, the maternal fevers could be bumped up to the 21­­­‒23% range. And actually three separate sources put the number of fevers in pregnant woman after the 2nd shot of the vaccine as ~30%, which would mean the number of maternal fevers in the first trimester would shoot up to the 36­­­‒38% range, an increase by a factor of 6. I simply can not believe that knowing the strong association of maternal fevers to birth defects that most OB-GYN's would be at ease with maternal fevers shooting up this high.

 This article gives the number of fevers, albeit in their small sample size as 32%:

ORIGINAL RESEARCH: OBSTETRICS|ARTICLES IN PRESS
COVID-19 vaccine response in pregnant and lactating women: a cohort study
Kathryn J. Gray, MD PhD, Evan A. Bordt, PhD, Caroline Atyeo, BS, Michal A. Elovitz, MD, Galit Alter, PhD, Andrea G. Edlow, MD, MSc
Open Access Published:March 25, 2021 DOI:https://doi.org/10.1016/j.ajog.2021.03.023
COVID-19 vaccine response in pregnant and lactating women: a cohort study - American Journal of Obstetrics & Gynecology (ajog.org)

  

 This report also puts the number of fevers in pregnant women as ~30%:

COVID-19 vaccine safety update
Advisory Committee on Immunization Practices (ACIP)
March 1, 2021
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team



 And this recently published article also puts the number of fevers in pregnant women after the vaccine as ~35% after dose 2:

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
List of authors.
Tom T. Shimabukuro, M.D., et al.
April 21, 2021
DOI: 10.1056/NEJMoa2104983

 So according to this article after you add on the ‒ 8% naturally occurring fevers, the number or maternal fevers could balloon to the range of 41 ‒ 43% in the first trimester. According to this data, it's particularly bad for the Moderna vaccine at 46% fevers in pregnant women after the 2nd dose. This would mean adding the naturally occurring fevers, the number of maternal fevers for those getting the Moderna shot would balloon to 52 ‒ 54% range.

 The CDC makes it seem like the COVID shot is just like the flu-shot. No, after the flu-shot perhaps 1­­­‒2% of people will get fever. But with the COVID vaccine shot a radically larger proportion of people will get flu-like symptoms such as high fever after the 2nd shot that are so severe it will keep them off work for a day or so. In fact this is so common that some hospitals have to stagger the days their staff get the vaccine to insure not too many people call in sick the same day after their shot:

Second COVID Shot Packs the Big Punch
— First dose also worse for those with previous COVID, but "small price to pay" for protection
by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today February 11, 2021
https://www.medpagetoday.com/special-reports/exclusives/91157
(May need free registration.)

 But as the article notes this can even happen after the 1st shot if the person had COVID-19 before. Most distressingly, it might even be the case that if the person had an asymptomatic case, so they didn’t know they had it, they could still get these severe reactions after just the 1st shot.

 And in this video Dr. Kavita Patel being interviewed says the side effects for 1/3rd of the people after 2nd dose feels like they have the flu. She herself had to take off. While many people wouldn’t take off for say a cold, the flu is more debilitating and most people do take off work then:

 This discusses the Pfizer and Moderna COVID vaccines. But the Astrazeneca vaccine also results in a high number of flu-like symptoms:

“But it turns out the side effects were underestimated, and we found ourselves with almost a third of health workers in some departments presenting severe symptoms and having to go on sick leave.”
https://www.thelocal.fr/20210225/french-hospitals-pause-astrazeneca-vaccine-campaign-as-temporary-side-effects-leave-many-staff-needing-sick-leave/

 It should be noted though that for the Astrazeneca vaccine the greatest side effects occur after the first shot, not the second.

 But in addition to the CDC emphasizing the  high prevalence of the "flu" after the shot, it also needs to be emphasized the length of time for these severe flu-like symptoms of a day or so is just the average length of time. For some people, perhaps 1­­­‒2%, they will be wiped out by this “flu” with high fever for over a week, obviously, quite concerning for the elderly and pregnant mothers.

 The CDC has put it on their web site there is a chance of the fevers after the COVID-19 shot. Even still, most doctors are not aware of the extent of these fevers and certainly most average citizens don’t know it.

  But I’ll explain why it is extremely important that this be commonly known.

 To obstetricians a well-known contributing factor to a very serious birth-defect known as neural tube defect is fever during first trimester in the mother. In fact the chance of this occurring can be increased multiple times when the mother has a 1st trimester fever. These birth defects include spina bífida, anencephaly, and encephalocele. Spina bifida most people have heard of where the baby is born with the spinal cord partially protruding through the back. Anencephaly is not as well known by the public, but it's where the baby is born with only a partially formed brain. And encephalocele is where part of the brain extrudes through the back of the head, [1].

 But fevers can also cause other birth defects in the 1st trimester such as heart defects, cleft palate, and autism. And the increased chance of these with maternal fever extends also into the 2nd trimester, [2].

 With the controversy over a claimed connection between vaccines in children and autism, it should be required to inform women that the chance is increased for autism in the child if the mother contracts a fever due to the COVID vaccine, under the principle of informed consent.

 Quite concerning also is the chance of the baby suffering one of these birth defects grows larger in an additive fashion with multiple fevers, up to a factor of 2 times larger with 3 fevers, [3].

 And for the serious neural tube birth defects, the degree of the increased chance is no small number. We are used to hearing of some drug causing an increased chance of some adverse effect by, say, 20% or 30%, but with maternal fevers the chance of the baby having a neural tube birth defect increases by 300% higher, when the mothers are not on the protective folic acid.

 Given this you would think obstetricians would give a caution to be wary of the fevers for pregnant mothers after getting the vaccine shot.

 So why haven’t they? My opinion is it’s because the CDC has not emphasized the prevalence of fevers after the COVID-vaccine shot. They have given the impression the side-effects are just like the flu vaccine.

 The CDC has been aware of the increased chance of birth defects with maternal fevers for several years now:

Maternal Fever During Early Pregnancy May Be Linked to Birth Defects.
https://www.cdc.gov/ncbddd/birthdefects/features/kf-birthdefects-maternal-fever-during-pregnancy.html

 A food additive called folic acid can lower, though not eliminate, the size of the increased chance. The CDC puts out an advisory that all women of child bearing years whether or not they are pregnant or plan to become pregnant take the additive and has seen that it is also included as an additive in some foods.

 The reason why it is important that all women of child-bearing years take the protective folic acid is that frequently women can be pregnant and not know it, early on. Then the warning of the danger of the increased fevers due to the vaccine in the first trimester should be extended to all women in child-bearing years even those not knowingly pregnant.

 But a problem is most women still don’t take or get enough of the folic acid.

 Then most women will still have the increased chance of the birth defects with fevers, such as those that occur to a high percentage of times with the COVID-19 vaccine.

 Moreover, this increased chance of these devastating birth defects will be worse for black women. The reason is even fewer black women get the protective folic acid, only about 20%. Then when the increase in these birth defects is seen to be especially high in black women the CDC can claim all they want they didn't know, but the response in the black community will be that they were targeted.

 The NEJM article has been cited to support the safety of the vaccine for pregnant women. But it is important note most of the completed pregnancies were for women getting the vaccine in the third trimester. But the danger of maternal fevers to birth defects is for the first and second trimesters. So the NEJM article can not address this key question.

 Tests for neural tube defects by either genetic markers, amniocenteses, or ultrasound can be done at about the 15th to 20th week of pregnancy. Women who were vaccinated in their first trimester in December or early January would now be in the time period for these types of tests to be done. It is imperative that such tests be done on all such pregnant women to insure this very serious type of birth defect does not occur at increased incidence after COVID vaccination.

II.)Possible Effect of COVID Vaccine on Infertility.

 As part of the justification being given for the safety of the vaccine in pregnancy, the animal studies Pfizer and Moderna did on pregnant rats have often been cited. The vaccine manufacturers have claimed that there were no statistically significant increases in infertility or birth defects in their rat studies. However, it is important to note there were increases in both infertility and birth defects in the rats for both the Pfizer and Moderna studies. 

 The claims of Pfizer and Moderna that these increases were not statistically significant, and therefore not "real", points out a major problem with medical studies that statisticians have complained about repeatedly in recent years. A difference in the data not being at the level of "statistical significance" does NOT mean it is nothing more than a random blip in the data, so not real. It just as well could be a real effect but the number of cases in the study is not sufficient for it to rise to statistical significance. 

 The issue is discussed in this article in the journal Nature:

COMMENT  20 MARCH 2019
Scientists rise up against statistical significance.
Valentin Amrhein, Sander Greenland, Blake McShane and more than 800 signatories call for an end to hyped claims and the dismissal of possibly crucial effects.
Valentin Amrhein, Sander Greenland & Blake McShane.

"When was the last time you heard a seminar speaker claim there was ‘no difference’ between two groups because the difference was ‘statistically non-significant’?

If your experience matches ours, there’s a good chance that this happened at the last talk you attended. We hope that at least someone in the audience was perplexed if, as frequently happens, a plot or table showed that there actually was a difference.

How do statistics so often lead scientists to deny differences that those not educated in statistics can plainly see? {emphasis added} For several generations, researchers have been warned that a statistically non-significant result does not ‘prove’ the null hypothesis (the hypothesis that there is no difference between groups or no effect of a treatment on some measured outcome)1. Nor do statistically significant results ‘prove’ some other hypothesis. Such misconceptions have famously warped the literature with overstated claims and, less famously, led to claims of conflicts between studies where none exists.

We have some proposals to keep scientists from falling prey to these misconceptions.

Pervasive problem

Let’s be clear about what must stop: we should never conclude there is ‘no difference’ or ‘no association’ just because a P value is larger than a threshold such as 0.05 or, equivalently, because a confidence interval includes zero. Neither should we conclude that two studies conflict because one had a statistically significant result and the other did not. These errors waste research efforts and misinform policy decisions."

https://www.nature.com/articles/d41586-019-00857-9

 In other words, for an observed large difference in the data, the difference should not be simply dismissed and regarded as not real just because it is not at the statistically significant level. The correct conclusion should be to do larger studies to determine if it is a real effect or not.

 A discussion of the Moderna rat study on the vaccines effect on fertility  appears on p. 50 to 51 of this report:

Assessment report
COVID-19 Vaccine Moderna.

https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf

 Moderna noted in the rat study that fertility dropped from 93.2% for the controls to 84.1% for the vaccinated rats. That means infertility doubled for the vaccinated rats, from 6.8% for the controls to 15.9% for the vaccinated.

 Moderna asserts this is within the normal range but no statistical significance values are provided so we can judge that.

 Other odd statements in this passage: Moderna’s researchers noted that the vaccinated pregnant rats wound up with limited use of their hind legs, but Moderna did not consider that to be an adverse event. That the vaccinated pregnant rats loss the use of their hind legs obviously should be concerning. Moreover, the fact it was the hind legs effected suggests also it’s related to the pregnancy.

 Then beyond that, Moderna noted that babies from the vaccinated rats had an INCREASE in skeletal birth defects. The Moderna researchers assert this is not an adverse event because it’s a common birth defect in rats. But how much was it increased? By 10%? Was it doubled, was it tripled? We’re not given that information. And again, even if the difference is not statistically significant, it is possible that these increased numbers of birth defects are real effects and that can only be determined by looking at larger studies.

 The Pfizer study on vaccinated pregnant rats is discussed here:

Assessment
Comirnaty

  The Pfizer researchers claim there were no observed difference in "fertility index" but the observed doubling in pre-implantation loss does amount to an increase in the pregnancy loss in the rats, i.e., an increase in infertility.

 The researchers assert it is within the normal range, i.e., not statistically significant, but again whether this is a real effect or not can only be determined by doing the study with a larger sample size.

 The phrasing in this passage also leads me to believe there was an increase in birth defects which the Pfizer researchers also say is not statistically significance. But again the validity of this claim can only be ascertained on a larger sample size.

 Note, even though both Moderna and Pfizer researchers assert no statistically significant difference in infertility, the size of the increase in both studies being doubled argues very strongly this is not coincidental, i.e., that it is a real effect.

 Because of the importance of this issue, these studies on vaccinated rats need to be published so they can be subjected to independent review, that is, by those not paid by the vaccine manufacturers, even if just a preprint on Medrxiv.com. 

 Other independent researchers need to confirm their validity. One key thing to check is to see if in future reproductive cycles, if the infertile rats had continue difficulty completing a pregnancy. If so, that would be alarming, since that would suggest the difference could be permanent. 

 The UK public health agency and WHO do not advise pregnant women in general to get the vaccine unless they are at high risk of getting COVID because of the lack of information either for or against its safety for pregnant women.

 But in the U.S., the CDC advises pregnant women consult with their doctor before getting the vaccine. Then both must be fully informed, including being made aware of the results of these studies.

 Even if it shown though the rat differences in infertility are real, that still would not mean that has to be the case in humans.

 For humans, fertility is usually determined over a year. However, the importance of answering this question about an effect on fertility is so great I suggest doing studies on the shorter time scale of 5 months since the vaccines have been released. Has there been a change in the number of pregnancies among those couples wanting to get pregnant when one or both members of the couple have been vaccinated?

 III. Could the vaccine induce auto-immune response within the placenta?

 Some scientists have argued that there is sufficient similarity of the spike protein to the syncytin proteins in the placenta that there could be cross-reactivity against the natural syncytins by the immune system in combating the COVID spike protein.

 This won't happen with B-cells which are very discriminating in the proteins they attack. However, T-cells are not nearly as discriminating. Still, E. Nirenberg argues against this possibility on the grounds the amino acid sequence where the synctins coincide with the COVID spike protein is too short:

Dec 3 
Written By Edward Nirenberg
Are COVID-19 Vaccines Going To Cause Infertility?

 However, to Nirenbergs credit he does mention in an addendum there is a known scenario where a similarly short amino acids sequence caused cross-reaction of rheumatic fever T-cells against normal heart muscle proteins.

 In an upcoming Part II, I'll discuss the evidence for and against the possibility the COVID vaccine could cause cross-reactivity with the synctin proteins of the placenta.


  Robert Clark


REFERENCES.

1.)Birth Defects Res. 2018 Mar 1; 110(4): 342–351.
Published online 2017 Nov 2. doi: 10.1002/bdr2.1147
Maternal report of fever from cold or flu during early pregnancy and the risk for noncardiac birth defects, National Birth Defects Prevention Study, 1997–2011
Dorothy Kim Waller,1 Syed Shahrukh Hashmi,2 Adrienne T. Hoyt,3 Hao T. Duong,4 Sarah C. Tinker,5 Michael Shayne Gallaway,6 Richard S. Olney,7 Richard H. Finnell,8 Jacqueline Tauber Hecht,2 Mark A. Canfield,3 and the National Birth Defects Prevention Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831519/

2.)Mol Psychiatry. 2018; 23(3): 759–766.
Published online 2017 Jun 13. doi: 10.1038/mp.2017.119
Prenatal fever and autism risk
M Hornig,1,2,* M A Bresnahan,2,3 X Che,1 A F Schultz,1 J E Ukaigwe,1 M L Eddy,1 D Hirtz,4 N Gunnes,5 K K Lie,5 P Magnus,5 S Mjaaland,5 T Reichborn-Kjennerud,5,6 S Schjølberg,5 A-S Øyen,5,7 B Levin,8 E S Susser,2,3 C Stoltenberg,5,9 and W I Lipkin1,2,10
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822459/

3.)Autism Res. 2017 Nov; 10(11): 1878–1890.
Published online 2017 Aug 11. doi: 10.1002/aur.1841
Prenatal exposure to fever is associated with Autism Spectrum Disorder in the Boston Birth Cohort
Martha Brucato,1,2,3 Christine Ladd-Acosta,1,3,* Mengying Li,4 Deanna Caruso,4 Xiumei Hong,4 Jamie Kaczaniuk,3 Elizabeth A. Stuart,5 M. Daniele Fallin,3,5,6 and Xiaobin Wang4,6
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5685874/

Monday, April 5, 2021

Asian countries routinely give anti-COVID antivirals EARLY. They have 1/100th the fatalities of the West. That’s not a coincidence.

 Copyright 2021 Robert Clark



In these articles once again nowhere did they even ask the question what treatments are they using in these countries with the radically reduced fatality rates. These are doctors investigating this remember, doctors whose job is to treat people, and they never ask the question how do you treat your sick.


 The national treatment protocols for COVID of giving antivirals EARLY for some of the Asian countries go all the way back to last year to March. It’s stunning when you think about it but if the question had been asked of them of what treatment strategies do you use, the researchers would have gotten the answer over and over again, “We use antivirals EARLY”, “We use antivirals EARLY”, “We use antivirals EARLY”, “We use antivirals EARLY”. It would then have been apparent that EARLY treatment with antivirals is important for bringing the virus under control.


 This study also concludes countries using anti-malarials are much better at keeping the epidemic under control:


National Consumption of Antimalarial Drugs and COVID-19 Deaths Dynamics : an Ecological Study.
“COVID-19 (Coronavirus Disease-2019) is an international public health problem with a high rate of severe clinical cases. Several treatments are currently being tested worldwide. This paper focuses on anti-malarial drugs such as chloroquine or hydroxychloroquine, which have been currently reviewed by a systematic study as a good potential candidate and that has been reported as the most used treatment by a recent survey of physicians. We compare the dynamics of COVID-19 death rates in countries using anti-malaria drugs as a treatment from the start of the epidemic versus countries that do not, the day of the 3rd death and the following 10 days. We show that the first group have a much slower dynamic in death rates that the second group.”


 Some national treatment protocols in Asian countries advising EARLY treatment with antivirals:


In China:


Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition)

Page Views 浏览量: 145539 Updated 发布时间:2020-03-16 12:00:32


http://kjfy.meetingchina.org/msite/news/show/cn/3337.html


And:


Health 17:30, 26-May-2020

COVID-19 treatment: Antivirals, anti-inflammatory drugs, blood thinner and mechanical ventilation

Updated 22:28, 26-May-2020

Antiviral treatment 
Ranko Škrbić, dean of the Department of Pharmacology at University of Banja Luka, asked about the most effective antiviral therapy that has been used in the Chinese hospital against the coronavirus. 
Hou Xinguo, Deputy Director of Endocrinology Department at Qilu Hospital, said that several antiviral drugs including alpha-interferon, ribavirin and abidol have been recommended in the COVID-19 diagnosis and treatment guideline issued by China's health authorities. But based on their clinical experience, the antivirals could be useful on patients only at the early stage of infection, as they did not have significant effects on severely ill patients. 
He added that according to the guideline, no more than two antiviral drugs should be used in combination.
 

https://news.cgtn.com/news/2020-05-26/COVID-19-Frontline-Chinese-doctors-share-treatment-experience-QNHrqxKtNe/index.html


And:


Published online 2020 Oct 8. doi: 10.1080/20016689.2020.1818446

PMCID: PMC7580738

PMID: 33133431

Chinese guidelines related to novel coronavirus pneumonia

Tingting Qiu, Shuyao Liang, Monique Dabbous, Yitong Wang, Ru Han, and Mondher Toumi

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580738/


In South Korea:


Gov't recommends use of antiviral drugs for COVID-19 treatment

Published on Feb 13, 2020

'고령중증에 에이즈치료제 권장'…코로나19 치료원칙 나왔다

South Korea has unveiled a set of treatment guidelines for COVID-19.
It consists of administering an anti-HIV medication twice a day.
This is the nation's first treatment protocol for those who show severe symptoms.
Kim Jae-hee has our top story.
Infectious disease experts in South Korea have agreed to the use of antiviral drugs in the treatment of severe coronavirus cases, senior patients, and those with underlying diseases.
On the other hand, it was concluded that young patients, or those with mild symptoms, seemed to have improved after 10 days and without any antiviral treatment.
"Young and healthy people have mostly shown improvement without any special treatment. But older patients or those with underlying diseases are in need of the medication from an early stage."
Expert says differences in treatment depending on a patient's age is actually quite normal.
"Most viral infections tend to heal even without any treatment... thanks to our body's immune system. But old age in itself can raise risks,... and many senior patients have underlying diseases, so it's recommended that they undergo antiviral treatment."
The government's guidelines recommend Kaletra, an anti-retroviral medication used to treat AIDS for a duration of 7 to 10 days.
Chloroquine or Hydroxychloroquine, a medication used to prevent and treat Malaria can be used as an alternative.
But experts says, while the government's announcement may sound promising, it might not make much of a difference to current treatment metThere won't be a significant difference in the treatment methods. It's an antiviral drug that we are already using, and its effectiveness has not been fully proven. It's still just a recommendation."
But the expert is optimistic, saying that the recurrence rate of the novel coronavirus is low.
"It seems unlikely that a recovered patient will catch the virus again. In fact, there are very few reports of patients being re-infected when they've recovered from other coronavirus diseases such as SARS and MERS."
He added that all seven of the patients who have made full recoveries in South Korea had no serious underlying diseases, and are unlikely to be re-infected.

Kim Jae-hee, Arirang News.

#Wuhan #coronavirus #drugs 

Gov't recommends use of antiviral drugs for COVID-19 treatment




In Taiwan:


Interim Guidelines for Clinical Management of SARS-CoV-2 Infection 

(5th edition) 

Translation Editor-in-Chief Prof. Wang-Huei Sheng, M.D. PhD et al.

Affiliation Department of Medicine, National Taiwan University 

Ministry of Health and Welfare 

Taiwan Centers for Disease Control 

March 26th, 2020 


https://www.cdc.gov.tw/En/File/Get/_Dv_q75ZjLcNeRvlnrPgUg


In Hong Kong:


News > Medscape Medical News

Triple Antiviral Combo May Speed COVID-19 Recovery

Neil Osterweil

May 11, 2020

https://www.medscape.com/viewarticle/930336

(May need free registration.)


And:


South China Morning Post

Hong Kong public hospitals to revise Covid-19 treatment guidelines, highlight effective drugs behind low mortality rates.

Victor Ting

27 August 2020·3-min read

Hong Kong’s public hospitals will revise clinical treatment guidelines for Covid-19 patients to better highlight the effectiveness of an antiviral drug that has helped achieve one of the lowest coronavirus death rates in the world.
Dr Owen Tsang Tak-yin, medical director of the Hospital Authority’s infectious disease centre at Princess Margaret Hospital, made the revelation at a media briefing on Thursday as the city’s third wave of infections showed signs of easing, with health officials reporting 21 new cases, taking the local tally to 4,755, with 81 related deaths.
“The third wave has been very rapid and fierce,” Tsang said. “But despite that, we have one of the lowest mortality rates worldwide, at about 1.6 per cent.”
One factor that helped suppress the death rate was effective treatment, which centred on a cocktail therapy involving antiviral drug Interferon; Kaletra, a drug originally used for HIV/Aids, and Ribavirin, which was also used for hepatitis C, according to Tsang.
The treatment guidelines, which were last updated in June, would be revised “very soon”, Tsang said, and would highlight Interferon as the major medication for Covid-19, combined with Ribavirin. But Kaletra may lead to some side effects and has proved to be unsuitable for some patients, causing liver problems in such cases.
Another antiviral drug, Remdesivir, was found to be most effective among patients in severe condition requiring oxygen support, but less effective in those who are critically ill and requiring intubation, while Hydroxychloroquine and Chloroquine have been ruled out as overseas research have shown their ineffectiveness.

https://sg.news.yahoo.com/hong-kong-public-hospitals-revise-142129309.html


 It’s notable that Hong Kong decided against HCQ following Western studies. But those studies did not test it for EARLY treatment which is essential for antivirals. But no matter. COVID-19 is a virus easy to treat. Multiple antivirals are effective treating if given EARLY.


In Thailand:


Am J Trop Med Hyg. 2020 Jul; 103(1): 48–54.

Published online 2020 May 18. doi: 10.4269/ajtmh.20-0442

PMCID: PMC7356442

PMID: 32431287

Critical Care Management of Patients with COVID-19: Early Experience in Thailand

Ranistha Ratanarat,1,* Chaisith Sivakorn,2 Tanuwong Viarasilpa,1 and Marcus J. Schultz3,4,5

Antiviral treatment before ICU admission.
Thailand has set national guidelines for antiviral treatment. Patients with mild symptoms receive chloroquine or hydroxychloroquine plus a boosted protease inhibitor, lopinavir or darunavir plus ritonavir. Favipiravir is not recommended in mild cases because of its limited availability.8
Favipiravir is an antiviral RNA polymerase inhibitor for which most preclinical data are derived from its influenza and Ebola activity.16 It is given to all patients with proven COVID-19 who have symptoms or signs consistent with pneumonia, or when there is hypoxemia (SpO2 < 95% on room air).8

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356442/


In Singapore:


Interim Treatment Guidelines for COVID-19 (Version 1.0, dated 2 April 2020) 

ABSTRACT Background In December 2019, pneumonia cases caused by a novel coronavirus occurred in Wuhan, Hubei Province. As of 11th February 2020, the World Health Organisation has officially named the disease “COVID-19”. In addition, virologists in the coronavirus study group have officially announced the name of the virus to be “SARS-CoV-2”. This guideline provides evidence-based recommendations on the therapeutic management of patients with COVID-19 in Singapore. 

https://www.ncid.sg/Health-Professionals/Diseases-and-Conditions/Documents/Treatment%20Guidelines%20for%20COVID-19%20%282%20Apr%202020%29%20-final.pdf



  Robert Clark

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