Covid-19 News

Quote from THHuxleynew

I agree, the equation changes if you have already caught COVID.

It does indeed. If you have already had COVID that is an even stronger reason to get vaccinated. It may prevent long-haul symptoms, which sometimes appear months after the patient recovers from the initial bout of the disease. It also strengthens immunity.

If you were hospitalized with COVID, and you refuse a vaccination, you are playing Russian Roulette. 10% of patients who were hospitalized die within months of being discharged and going home.

One in 10 Covid patients die within months of leaving hospital, study reveals

More than half of Covid patients suffered complications in hospital, with young people worst affected

www.independent.co.uk

Quote from THHuxleynew

I think that anyone who goes against the advice of their local medical professionals needs strong reasons.

80% of local doctors blindly follow the herd = money = pharma mafia. So you need first to find an independent one.

Quote from THHuxleynew

I think to be not believing advice from health authorities in any country with competent authorities is a strong statement - doing this in the direction of less vaccine makes you an anti-vaxxer, or one of the many influenced by anti-vaxxers. Specifically, the regulatory authorities take risks very very seriously and only recommend vaccines when risks of vaccine are, in their judgement, less than risks of not taking the vaccine.

The so called medical experts you claim are FM/R/XXX/B governments select buddies that are willful supporters of Big Pharma and corrupt down to the bone marrow.

No real medical experts are present in any western gremium that gives public advice. I suggest that you follow them. I will not even listen to them or just to have some fun!

Quote from THHuxleynew

I'd say the mRNA vaccines look less risky (no blood clots)

This is plain vanilla FUD: These vaccines produce a similar amount of blood cloths, just the technical term is a bit different. Like blood disorder - is much worse than clots as more or less not treatable only for the heparin like version a treatment has been found so far.

Quote from THHuxleynew

Contrary to what W says above, tweaking a vaccine for new variants is commonly done, e.g. with Flu. It can be done over 6 months and does not take 10 years.

You know simply nothing. A flu vaccine is a cocktail of about 10 known and fully tested vaccines. Nothing new at all.

Your posts are a source of potential live damage to people that will believe experimental = "mostly untested" vaccines are save. So what you say is basically criminal.

Quote from Shane D.

This South African doctor says Ivermectin is useless, and dangerous:

Quote from Shane D.

His colleague says just the opposite:

Where does that leave the laymen? When experts disagree, we just don't know what to think. I don't, anyway.

When there is a consensus about a controversy, where one side has more experts who seem to be informed, I assume that side is right. Needless to say, that is a dangerous assumption, as we have seen in cold fusion and various other subjects. But what can I do? I can't be an expert in every subject. People such as QANON believers nowadays say "do your own research." That's dangerous! Most of us are incapable of doing any research. Most people don't know where to begin doing real research. I never say that. I say, "do your homework." Meaning, read what the experts have to say and try to understand it if you can, but try to be honest with yourself if it is over your head. Avoid the Dunning Kruger effect.

Quote from Fm1

Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses

https://casereports.bmj.com/content/14/7/e243829

Abstract

A 61-year-old man presented to the ENT emergency clinic with a history of unilateral facial nerve palsy occurring shortly after each dose of the Pfizer-BioNTech COVID-19 vaccine. The first episode developed 5 hours after administration of the first dose and the second 2 days after administration of the second dose. Investigations at initial presentation to the emergency department were unremarkable, and the patient was diagnosed with Bell’s palsy on both occasions. We describe the first case of Bell’s palsy occurring after each dose of any UK-approved COVID-19 vaccine. Single episodes of unilateral facial nerve palsies have been reported in clinical trials and in subsequent case reports. There has been no evidence, however, of an episode after each dose. We also describe the earliest onset of symptoms from timing of administration of the vaccine, further suggesting the Bell’s palsy was associated with the vaccine.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

http://dx.doi.org/10.1136/bcr-2021-243829

Discussion

Bell’s palsy is defined as a rapid unilateral facial paresis or paralysis of unknown cause.13 Although the aetiology is unclear, the pathogenic mechanism is believed to be related to facial nerve inflammation and oedema caused by a virus. Most patients show some recovery without intervention in 2–3 weeks and the majority of cases resolve within 3–4 months. Risk factors include diabetes, obesity, hypertension, pregnancy, pre-eclampsia and upper respiratory disease.13 Although most cases spontaneously recover with time, the symptoms can cause significant temporary disability for patients, affecting their facial expression and ability to eat and drink. Long-term facial weakness can lead to significant morbidity along with high rates of anxiety and depression.14

Bell’s palsy has previously been linked with influenza vaccinations. In 2004 the inactivated intranasal influenza vaccine was shown to significantly increase the risk of Bell’s palsy and was discontinued.15 Increased incidence of Bell’s palsy has also been described with administration of other multiple influenza and meningococcal vaccines, although a causal link has not been established.16

A possible mechanism of action could involve reactivation of the dormant virus within the CNS causing facial nerve inflammation or oedema after administration of the vaccine. A proposed mechanism of idiopathic facial nerve palsy suggests reactivation of latent herpes virus in a similar mechanism to Ramsey Hunt syndrome and the reactivation of the varicella zoster virus.17 Autopsies have also confirmed that COVID-19 viral RNA is present in the CNS.18 However, we are unable to account for the rapid onset of the facial nerve palsy.

A review of the current literature produced two formal case reports of unilateral facial nerve palsy occurring after receiving the Pfizer-BioNTech COVID-19 vaccine. In Los Angeles, a 57-year-old woman developed a severe Bell’s palsy 36 hours after administration of her second dose of vaccine.19 The dose was given 19 days after the first dose. The patient had a left-sided facial palsy and improved with an antiviral and steroid. Of note, the patient had a history of three previous episodes of Bell’s palsy which had affected her on both sides. Similarly, a unilateral facial nerve palsy was reported in a healthy Italian 37-year-old man, occurring 5 days after his first dose of vaccine. The patient had no significant past medical history or previous Bell’s palsy and made some improvement with high-dose steroids.20

We describe the first case of two discrete contralateral facial nerve palsies to be reported in the literature following both doses of the Pfizer-BioNTech vaccination. This case also describes the earliest onset of symptoms after administration of the vaccine compared with the two aforementioned cases and those within the clinical trials. The occurrence of the episodes immediately after each vaccine dose strongly suggests that the Bell’s palsy was attributed to the Pfizer-BioNTech vaccine, although a causal relationship cannot be established.

Learning points

Given the rapid roll out of the COVID-19 vaccine, it is essential that clinicians are vigilant and report adverse effects in a timely manner.

Our case is the first reported incidence of two discrete contralateral episodes of Bell’s palsy shortly after receiving his first and second doses of the Pfizer-BioNTech COVID-19 vaccine.

The current data from clinical trials do not wholly comment on relevant medical history or previous cases of Bell’s palsy in those who suffered side effects.

Healthcare professionals should continue to report and share these findings in order to further investigate the potential of a causal relationship and the pathophysiology underlying Bell’s palsy. A longitudinal cohort study could be used for further analysis of these cases.

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Bell's palsy is scary.

It can be caused by many things so has quite a high natural rate: 150 - 300 per 1,000,000 per year.

There is not much doubt that it can be caused by both COVID and the vaccine.

These statistics are particularly easy to fudge - and this can be done both ways - by anti-vaxxers or by people seeking to minimise apparent risks. While anti-vaxx papers (historical average) tend to do this much more egregiously than normal research papers, undoubtedly both can happen. There are lies, damned lies, and statistics.

I'm going to go through the data and how it is analysed in great detail below so you can see this and decide for yourself.

Direct comparison in a matched study shows the COVID rate to be 6.8X larger than the vaccination rate.

This is looking at a window 8 weeks after the vaccination (or the COVID).

I am slightly suspicious of this figure. They say they matched cases (the right thing to do). If they did this properly this result holds, and properly shows a rather high rate of BP from COVID. Even though BP is a side effect of vaccination, if vaccination reduces the severity of COVID, or the chances of catching it gain, that 6.8X figure means you should go for the lower vaccination risk. Also, if it is supposed that mRNA vaccines have a higher risk than others, we would want to consider which vaccine was administered. This was the US so I'd expect quite a lot of mRNA vaccine. But mainly I would need to see all the details of the matching, which matter. i am not surprised by this result - COVID does the sorts of things (it is a virus - it mucks up the auto-immune system) that can cause BP.

Now let us look at the data from the Pfizer and Moderna trials. The official view is "no evidence here for a causal link". Here is a lancet publishes anti-vax PR slanted analysis:

Media reports have stated that the incidence of Bell's palsy among participants of the Pfizer-BioNTech and Moderna vaccine trials is comparable to that observed in the general population. The FDA briefing on the Pfizer-BioNTech trial stated “observed frequency of reported Bell's palsy in the vaccine group is consistent with the expected background rate in the general population”, although this statement was removed from the subsequent FDA briefing on the Moderna trial. However, this reporting is based on a misconception, driven by a subtle distinction between rates and proportions, that has persisted in the lay media. The estimated incidence rate of Bell's palsy in the general population ranges from 15 to 30 cases per 100 000 person-years. Since the 40 000 vaccine arm participants were followed for a median of 2 months, the combined safety population receiving vaccine across the two trials represents roughly 6700 person-years of observation time for an expected incidence of Bell's palsy of one to two cases, in line with the single observed case in the combined placebo arms. Therefore, the observed incidence of Bell's palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population. This finding signals a potential safety phenomenon and suggests inaccurate reporting of basic epidemiological context to the public.

Note the anti-vax signature; alarming figures of danger followed by an insinuation that we have been misinformed by the regulator.

I am happy to engage with the correct figures. I deplore the insinuation. On the question of "do mRNA vaccines cause Bell's palsy" the answer is probably yes. Just as "does COVID cause bell's palsy" the answer is certainly yes.

Here is a comment on the above paper, also published in the Lancet.

Despite geographical and seasonal variations,^{3, 4} the generally agreed incidence of Bell's palsy is 15–30 cases each year per 100 000 population. Ozonoff and colleagues² rightly state that the predicted 12-month (annual) incidence of Bell's palsy inferred from mRNA vaccine trials is higher than that reported during the 2-month observation period of these studies. They concluded that the observed incidence of Bell's palsy in the mRNA vaccine arms was 3·5 to seven times higher than expected in the general population. However, safety data were collected for participants with a median follow-up of 2 months after the second dose; therefore, the data refer to an overall observation period of approximately 12 weeks from dose one. Given this, and considering Bell's palsy as the possible outcome of individual doses, the observed incidence in the mRNA vaccine trials would be roughly 1·5 to three times higher than in the general population (table).

They original (anti-vax slant) paper mis-stated the overall observation time in these trials, so when comparing trail counts with natural incidence they got a signal 2X larger than is actually correct, and as a result accuse the regulators of deceiving the public. Now, I am not going to say they did this on purpose. It is very easy to get these analyses wrong and obtain wrong results. this was a fairly obvious case, but easy to overlook. However, when the mistake is corrected, the "no clear evidence based on the trial data" conclusion is correct. There is however an indication from the relative trial data.

from the (no obvious PR) correction:

The numerical imbalance reported with mRNA vaccine trials was not seen in the Oxford-AstraZeneca and Johnson & Johnson phase 3 studies using more traditional virus-based technology. Examination of adverse event data from the Yellow Card scheme in the UK and from the EU EudraVigilance database might help clarify this matter. As of March 21, the Yellow Card-reported frequency of facial paralysis or paresis and facial nerve disorder after any dose was close to 23 per million with the Pfizer-BioNTech vaccine and 13 per million with the Oxford-AstraZeneca vaccine. Excluding reports of facial paralysis cross-listed with cerebrovascular accident, EudraVigilance data indicate a much higher frequency of facial paralysis after the Pfizer-BioNTech vaccine than after the Oxford-AstraZeneca vaccine (497 vs 56 cases or 13·6 vs 4·1 per million doses as of April 3). The risk of developing facial paralysis could be two to three times higher in individuals receiving mRNA vaccines than in those receiving traditional vaccines. These findings should be considered when selecting a vaccine for patients with a history of Bell's palsy.

Thus it seems likely the mRNA vaccines can cause Bell's palsy at a slightly higher than background rate.

From my POV the take-home here is as follows:

• It seems likely that mRNA vaccines do increase risk of Bell's palsy
• The vaccine trials were randomised, so reliable, but not large enough to settle this
• The real-world data needs to be followed up - but getting accurate risks information from this will not be easy!
• It seems likely - but not certain - that COVID induces a much higher rate of BP than the mRNA vaccines. The referenced study above has too little information to be sure it is helpful. Call it pro-vaxx propaganda if you like.

Why will it not be easy getting accurate risk information from the real-world data? Bell's palsy risk varies across demographics and with age. When comparing BP incidence from yellow card reporting with natural BP inclidence we muts match for this, since the people who are vaccinated are not at all a fair random sample of the population. They are skewed towards older age groups and in other ways. we need, in a retrospective study based on this data, accurate matching for any confounder (like age) that could affect the results. Based on initial data anyone with a history of BP is less likely to be given mRNA vaccine, which further could skew the results (I';m not sure by how much).

So - my point about this is that working out real risks is not simple, and misrepresenting real risks is easy. The thing I dislike is when a researcher as in the first lancet paper makes a mistake in their analysis and then is so pig-headed that they accuse others of being deceitful. To be fair both of these papers were published, and civilised enough. Mistakes can be corrected in a refutation as here. And the overall point - do mRNA vaccine increase risk of BP - is not fully answered, though it seems likely that they do, and further work is needed.

For those here who want to gauge their own personal risk I suggest the following:

(1) Use quantitative risks, comparing overall nasty thing risk, for you, of COVID and any specific vaccine. Although BP is scary, death is scarier. For me, long-term COVID brain fog is scarier than BP, although i accept that might not be so for everyone. But BP is juts one of very many nasty COVID side effects and (a few) nasty vaccine side effects, all of which you need to weight.

(2) All of these vaccine risks are at very low levels. You can check your network of 1000 friends and even for a risk the regulator would see as unnacceptable, no-one you know would likely suffer it.

(3) Anecdotal information does not help. "I and my friends did not get bad COVID". means nothing, when average risk of death is 0.5% (say) and risk of something nasty is maybe 3%.

(4) Anecdotal information does not help. "A patient of mine developed BP 1 day after being vaccinated". Assuming it is a causal link (which we cannot always, because it will happen by chance) it gives no information on the real risks.

(5) Interpreting individual findings for yourself is difficult. the statistics are not simple to analyse. internet sources can easily slant the analysis either way.

My experience has been that the anti-vaxx papers on the internet contain obvious mistakes in analysis (that is the most charitable reading - there are other ways to describe it which in the worst cases seem much more likely). The mainstream papers do not contain as high an incidence of same mistakes - peer review helps with that. Even so each paper must be read within an overall context that may give different slants before you have good enough assurance to contradict the regulatory panel who will have reviewed the whole literature, and update advice in real time as new data comes in.

Quote from JedRothwell

Most people don't know where to begin doing real research. I never say that. I say, "do your homework." Meaning, read what the experts have to say and try to understand it if you can, but try to be honest with yourself if it is over your head. Avoid the Dunning Kruger effect.

I would add time also to let experts and fact checkers and fact fact checkers respond in a correct way. The maddening in all this is that folks usually make up their mind way too quickly and the hyperbole wins to often because of this.

We need a really well executed RCT here to solve the controversy. I do think it is safe, if treated correctly, and the problematic side effects with ivermectin is stemming from not having doctors prescribing and controlling the intake but in stead self medication and using ivermectin variants not done for humans.

Both these articles experts do not address why the most common sources of biases explaining what they see is not valid, So I don't find them being critical enough over their own arguments about their conclusion due to this. But it is a nice example of why medical science exists.

Re the indian study. Maybe this is linked before, but here is the paper paper

Look like they estimated from three sources

1. IFR and the fraction having antibodies 4 million

2. From a rather large panel (subsample) of India 4.9 million

3. extarpolation from civil registrations 3.4 million

I do not see any analyses or professional critique out there yet, but

at first look it looks like a quite solid conclusion as it is deduced form three

independent sources.

The plot re BP thickens.

In fact - those not statistically very significant early results look like a fluke - but even this is not certain. The real-world data from 300,000,000 vaccine doses could be skewed, for example with people at higher risk of BP advised not to get mRNA vaccines. Nevertheless, I think it is a pretty good better analysis and because of much larger numbers takes precedence over the trial data.

Association of Facial Paralysis With mRNA COVID-19 Vaccines

This disproportionality analysis uses the World Health Organization pharmacovigilance database to explore the potential safety signal of facial paralysis after…

jamanetwork.com

It is comparing risks across different vaccines - not saying vaccines have no risk of BP. But, for example, there seems generally more suspicion of mRNA vaccines than say influenza vaccine and that is clearly not warranted by these figures - in fact it is the other way round!

What I'd hope everyone here gets from this discussion is that these analyses of tiny risks are really difficult to interpret. If you base a vaccine or no vaccine decision - or even a which vaccine decision - on individual scare stories you will be essentially acting randomly. The regulators have the job of balancing all this stuff. They do not do it badly - and you can get added assurance by comparing regulatory decisions in different countries.

Quote from stefan

Re the indian study. Maybe this is linked before, but here is the paper paper

Look like they estimated from three sources

1. IFR and the fraction having antibodies 4 million

2. From a rather large panel (subsample) of India 4.9 million

3. extarpolation from civil registrations 3.4 million

I do not see any analyses or professional critique out there yet, but

at first look it looks like a quite solid conclusion as it is deduced form three

independent sources.

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Yes. all these figures can be questioned - they do a nice job of pointing out the issues and note that three different methods give broadly comparable results.

That also (mildly) validates the internationally accepted age-specific IFR from COVID.

Quote from Wyttenbach

80% of local doctors blindly follow the herd = money = pharma mafia. So you need first to find an independent one.

That is perhaps a bit contemptuous of doctors. Those in my family who have been doctors have not, I think done that. I guess that some do. There are rotten eggs in every barrel.

Don't forget

• 10% of doctors become obsessive about pet ideas (whether that is "vaccines are dangerous" or "homeopathy works" or "drugs do more harm that good". All of these ideas have some validity - but they can easily be overdone. (Homeopathy works in the sense that being able to talk to somone who behaves professionally and listens helps many patients, rather than as a physiologically effective treatment - water is not that).
• 50% or more of doctors have no or little scientific training and therefore will not be able to interpret the scientific literature for themselves

That is why we have medical regulators, etc - otherwise we would still be using leeches widely (OK - I know they have been used recently with some success, narrowly - but not for every condition under the sun).

Independent (in an obvious way) doctors are often just those with particular cranky ideas that go against what most informed people think. Those ones are usually, though not always, wrong. I think most doctors think, and as people do not blindly accept orthodoxy, nor blindly reject it.

Quote from Shane D.

His colleague says just the opposite:

Liver damage?... maybe they took remdesivir.or too much panadol

not enough info from the facebook post..

for sure the patients had Covid,,

"In this study, abnormal liver function was observed at a high frequency in patients with mild–moderate SARS-CoV-2 infection.

https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.12599

Quote from THHuxleynew

Yes. all these figures can be questioned - they do a nice job of pointing out the issues and note that three different methods give broadly comparable results.

That also (mildly) validates the internationally accepted age-specific IFR from COVID.

Thanks, what i'm after is the independence of the calculations. I would preferable had the different calculations entirely independently done (blindly). What to look for when it comes to the power of this as evidence is that they did not tweaked the other two calculations out of the result of one. (We had an accident in one of our nuclear facilities, that thank goodness was stopped, but here the culpit was that many on paper independent safety systems was indeed not independent due reasons found in the link here after, The Forsmark incident

Quote from stefan

I do not see any analyses or professional critique out there yet, but

at first look it looks like a quite solid conclusion as it is deduced form three

independent sources.

It will probably never be possible to estimate the death toll in India with any degree of precision. But that does not mean it cannot be estimated at all. This paper shows there are multiple approaches to making estimates, and they agree to within an order of magnitude. That is better than nothing.

One of the methods the authors used was to estimate the death toll is by looking at excess deaths; that is, deaths in 2020 compared to other recent years. This has been applied to the U.S. and other countries. It indicates that more people probably died from COVID than the official statistics indicate, especially during the first months of the pandemic when testing was inadequate. That is not surprising. It was not difficult for doctors to recognize a COVID case, or to confirm that the main cause of a death was COVID, so there were not many false positive death certificates. Whereas many people died at home or died without ever being tested, so the cause of death was not listed as COVID (a false negative).

Just looking at excess deaths alone, without other data, you cannot know with precision how many excess deaths were caused by COVID, and how many were caused by other things. COVID may play an indirect role, for example by increasing drug overdoses, or diseases not treated because the hospitals were overwhelmed by COVID cases. You can make a reasonable estimate by comparing various sources, as the authors of this study have done. You can also tighten up the statistics as more data comes in. For example, we now know that ~93,000 people died of drug overdoses in the U.S., a record high. So we can subtract that from the excess deaths. You subtract other known sources of deaths in 2020 from the excess death figures, and you are left with approximately how many people probably died from COVID, or a combination of COVID and other causes. The CDC estimates that ~66% of excess deaths last year were from COVID:

Excess Deaths Associated with COVID-19, by Age and ...

This report describes the estimated excess deaths reported in the United States from late January through October 3, 2020, with 66% excess deaths attributed to…

www.cdc.gov

Epidemiology is a grim business.

Quote from RobertBryant

Liver damage...

I don't have time to watch all fake video's. The last story was about a woman that claimed to take tons of Ivermectin nobody could legally get except a horse farm...

If you drink 6..7 litter water in a row then you kill yourself... Sounds simple! No receipt needed!

Quote from JedRothwell

Just looking at excess deaths alone, without other data, you cannot know with precision how many excess deaths were caused by COVID, and how many were caused by other things.

For USA it looks really bad. Live expectancy plummeted almost by two years!! Here(Switzerland) nothing is seen except about 1000 excess deaths for a period of 2 months just among people age > 65.

So every country is different. Meager,sick India versus over-fat USA could be the same for different reasons.

But we should look at how these countries solve the crisis. Now USA already has about 4x the CoV-19 cases of India. India is at about 40'000 cases in average/day for 1350 mio people USA 38'000 for 333 mio. India is also claimed to have 67% antibodies now. In India mainly two states fail that contribute more than 50% of the cases. In USA Florida is the same problem but IFR is below 1%. But what is the influence of the vaccines?? IFR =1% since January!

I tend to argue that public data is vastly incomplete as Inida shows with close to 70% anti bodies now. Nobody wants to know the exact figure here, since we now know that people with antibodies no longer need vaccines...

Quote from JedRothwell

It will probably never be possible to estimate the death toll in India with any degree of precision. But that does not mean it cannot be estimated at all. This paper shows there are multiple approaches to making estimates, and they agree to within an order of magnitude. That is better than nothing.

One of the methods the authors used was to estimate the death toll is by looking at excess deaths; that is, deaths in 2020 compared to other recent years. This has been applied to the U.S. and other countries. It indicates that more people probably died from COVID than the official statistics indicate, especially during the first months of the pandemic when testing was inadequate. That is not surprising. It was not difficult for doctors to recognize a COVID case, or to confirm that the main cause of a death was COVID, so there were not many false positive death certificates. Whereas many people died at home or died without ever being tested, so the cause of death was not listed as COVID (a false negative).

Just looking at excess deaths alone, without other data, you cannot know with precision how many excess deaths were caused by COVID, and how many were caused by other things. COVID may play an indirect role, for example by increasing drug overdoses, or diseases not treated because the hospitals were overwhelmed by COVID cases. You can make a reasonable estimate by comparing various sources, as the authors of this study have done. You can also tighten up the statistics as more data comes in. For example, we now know that ~93,000 people died of drug overdoses in the U.S., a record high. So we can subtract that from the excess deaths. You subtract other known sources of deaths in 2020 from the excess death figures, and you are left with approximately how many people probably died from COVID, or a combination of COVID and other causes. The CDC estimates that ~66% of excess deaths last year were from COVID:

https://www.cdc.gov/mmwr/volumes/69/wr/mm6942e2.htm

Epidemiology is a grim business.

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Interestingly If you look at excess death as the combined effect of social adaptation to the pandemic and the pandemic itself lead to the following excess figures, excess comparison, you see England and USA at 10-12% and Sweden at 1.5%. That's an order of magnitude difference. But the official covid figures indicates basically the same order of magnitude.

University of Iowa Led Observational Study Reveals Remdesivir Can Lengthen Hospital Stay & Not Contribute to Survival

University of Iowa Led Observational Study Reveals Remdesivir Can Lengthen Hospital Stay & Not Contribute to Survival

University of Iowa Carver College of Medicine led a multi-site study finding that the only formally approved drug by the U.S. Food and Drug Administration

trialsitenews.com

University of Iowa Carver College of Medicine led a multi-site study finding that the only formally approved drug by the U.S. Food and Drug Administration (FDA) actually led to lengthier hospitalization duration, or was associated with such an observation. That is, the hospitalized patients infected with SARS-CoV-2, the virus behind COVID-19, were actually ready for discharge yet the hospital had to keep them until their 5 and 10-day remdesivir course was completed! Of course, all the while, the drug’s producer benefits (another utilized dose regimen) as well as the hospitals assuming they are compensated for the time. Led by Michael Ohl, MD, MSPH, associate professor of internal medicine with University of Iowa Health Care and a practicing doctor at Iowa City Veterans Affairs Health Care System, these findings raise some interesting questions. Again, the World Health Organization (WHO) has declared based on the results of the Solidarity study that remdesivir provides absolutely no benefit and, in fact, in much of the world, remdesivir isn’t administered for COVID-19. That’s very different in places like American where a biased stew of elements and factors play out to the background of billions accumulated by remdesivir’s maker, Gilead.

Despite the fact that the WHO has recommended against remdesivir for a long time now and some safety profile questions, remdesivir is probably the most administered COVID-19 drug in America. For all those that don’t remember, Gilead benefited from what appeared to be white-glove treatment from a pivotal Phase 3 clinical trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), and its director Dr. Anthony Fauci.

During the pivotal trial at the early onset of the pandemic, Fauci allowed for the changing of clinical trial endpoints, which helped ensure a good look at the drug. That worked—the FDA issued an emergency use authorization (EUA) in May and, later in October, it was formally approved. The WHO Solidarity findings came a few months later. TrialSite suggests that to Fauci and NIAID’s defense, there was enormous pressure at that time to produce some results to help fight a horrific, surging pandemic. But of course, this platform has systematically covered the seeming bias inherent in current research and development agencies and institutes, favoring expensive novel therapies over the potential for low-cost, generic yet potentially pragmatic early-onset care approaches.

Based on myriad encounters reviewing numerous studies, TrialSite suggests these findings indicate health systems, hospital administrators, and physicians need to consider remdesivir more carefully, exactly when and when it will not add to the patient’s benefit while reducing hospitalization.

The Study

The study was conducted at 123 Veterans Health Administration hospitals from the period of May 1 2020 to October 8, 2020.

In this study, the team, which included not only investigators from the University of Iowa but also the VA Bedford Health Care System, University of Massachusetts, Lowell, as well as VA Puget Sound Health Care System and University of Washington, Seattle, tracked 2,344 hospitalized adults with SARS-CoV-2 in 123 hospitals, demonstrating that remdesivir actually served to increase hospitalization duration length. However, the drug’s impact didn’t improve 30-day survival.

The study authors concluded that A) for a particular cohort in the study, the study drug didn’t associate with survival, however, did associate with lengthier hospitalization duration, and B) results suggest that routine remdesivir usage may be associated with lengthier hospital bed utilization but not improvements in patient survival.

Study Limitations

This study, like all, has some limitations. In this case, it’s an observational study, which is weighted less heavily than randomized controlled trials. Secondly, the observations only apply to 49.5% of the patients in the total group for whom the investigators could match to controls. These particular patients had a lower propensity for remdesivir treatment and less severe illness as compared to others, reports the authors. Finally, due to study data limitations, the authors couldn’t break down the subjects into more granular categories, thus showcasing which “subgroups of patients who may have been more likely to benefit from remdesivir treatment and from precisely emulating clinical trials.”

Lead Research/Investigator

Michael E. Ohl, MD, MSPH, University of Iowa, Carver College of Medicine, Iowa City Veterans Affairs (VA) Health Care System

Call to Action: See the study here.

Quote from Wyttenbach

You know simply nothing. A flu vaccine is a cocktail of about 10 known and fully tested vaccines. Nothing new at all.

Your posts are a source of potential live damage to people that will believe experimental = "mostly untested" vaccines are save. So what you say is basically criminal.

My contention that a new tweaked vaccine can be made, tested, agreed in 6 months, as long as similar to old ones:

The virus must first be adapted for use in manufacturing vaccine. To make the vaccine virus less dangerous and better able to grow in hen’s eggs (the production method used by most manufacturers), the virus is mixed with a standard laboratory virus strain and the two are allowed to grow together. After a while, a hybrid is formed which contains the inner components of the laboratory strain, and the outer components of the pandemic strain. It takes roughly three weeks to prepare the hybrid virus.

So this is 6 months from isolating a new virus! And it is not mix and matching old vaccines.

W - I'd believe your assertions more if whenever I checked them they proved correct. I was ready to admit error on this, since indeed yearly Flu vaccines are normally mixes from existing strains.

The full process, in a best case scenario, can be completed in five to six months. Then the first final pandemic vaccine lot would be available for distribution and use.

Since we are trading insults: you are the one claiming you are correct and regulators throughout the free world, as well as the vast majority of scientists throughout the free world, are wrong. You are counselling people not to get vaccines for COVID. If any believe you, and act on that belief, they are at much greater risk of getting COVID. The decision is obviously a risk balance: vaccine vs COVID.

Were I in your position it would make me very nervous. I am never that confident of being correct when others argue differently with coherent arguments.

Are the ‘Unvaccinated’ the Reason the Pandemic Isn’t Ending? Some Healthy Skepticism in Response to Recent POTUS Claims

Are the ‘Unvaccinated’ the Reason the Pandemic Isn’t Ending? Some Healthy Skepticism in Response to Recent POTUS Claims

Recently, Laura Ingraham had Yale University epidemiologist Dr. Harvey Risch, a contributor to TrialSite News, as well as researcher and author Alex

trialsitenews.com

Recently, Laura Ingraham had Yale University epidemiologist Dr. Harvey Risch, a contributor to TrialSite News, as well as researcher and author Alex Berenson on her show to discuss taking an honest look at the trends behind breakthrough COVID-19 cases, or fully-vaccinated individuals who become infected with COVID-19, and also the growing call for more lockdowns and the use of masks. Is it true that the unvaccinated, and not a confluence of factors from the Delta variant to breakthrough infections to the social determinants of health and more, are the reason the pandemic is persisting?

POTUS and various individuals associated with the White House recently declared on national media that the unvaccinated were to blame for the pandemic, but is this provocative claim based on established data? It’s not clear if it is. For example, data coming out of the UK and Israel suggests that individuals who are fully vaccinated are susceptible to infection. TrialSite discussed the Israeli data, which shows that breakthrough infections in one of the world’s most vaccinated countries represent a growing challenge.

Breakthrough cases of COVID-19 in individuals who are fully vaccinated are happening, so why is Biden declaring this a pandemic of only the unvaccinated? It doesn’t make sense if you look at the number of new cases in the UK and Israel who are fully vaccinated while considering that along with an increasing case rate. Breakthrough cases are also being hospitalized. As of July 20, 40% of hospitalized COVID-19 patients in the UK are fully vaccinated, while 60% are unvaccinated. In Israel, of the 143 people hospitalized, 58% are fully vaccinated and 39% are unvaccinated. In July, 20 people in Israel died from COVID-19, more than double the death rate in June, and 15 of them were fully vaccinated.

Just yesterday, CNBC reported people in the US have still died or been hospitalized from COVID-19, despite being fully vaccinated. CNBC also reported that 76% of hospitalizations from breakthrough cases occur in individuals over 65. Is this due to the potency of the Delta variant, waning immunity from the vaccine, or underlying health conditions?

TrialSite also reported that Delta-driven COVID-19 cases are increasing in some of the most vaccinated states in America, especially amongst the poor and minority groups. The Delta variant is more infectious than the original viral strain, but it’s not clear yet if it’s more dangerous.

Alex Berenson, a researcher and author, responded to Ingraham that the Biden administration is outright lying, based on data out of Israel and the UK. He pointed out that there is a massive number of cases in both countries, including breakthrough infections. Claiming that serious cases and deaths are only associated with unvaccinated people isn’t the case in the UK or Israel. The vaccines are protective, Berenson acknowledged, but emphasized that the vaccine clinical trials weren’t powered to assess durability, meaning we don’t know the length or strength of vaccine-induced immunity. The clinical trials also included few elderly people, who may be at the greatest risk for breakthrough cases.

Berenson shared that, for some reason, “POTUS is punishing people like me and trying to get Twitter to de-platform people like me and attack people like you” referring to Ingraham, which the author denounced as “just wrong.”

TrialSite suggests POTUS isn’t lying but rather has bought into a unifying, totalistic narrative that may not represent a truly accurate understanding of what’s truly unfolding now. The pandemic, novel vaccines, a lack of early care options—at least formally authorized by health authorities—along with politicization from all sides, makes the overall situation ever more tense and volatile. Certainly, the right answer, however, is not to just point the finger at a large group of people and declare they are the only problem. That more than likely will have an oppositional consequence, one that will unleash further divide, we unfortunately anticipate. What’s needed is more unity, more acceptance of diverse concerns, and more transparency into risks of the current vaccination program across the board. With transparency comes trust and engagement.

So 92000 dies here per year, excess death of 1.5% of that for 1.5 years

lead to 2000 deaths. WTF, we have 14500 covid dead now. So is there something fishy

here.

I found the cludge, the excess death was the second half of 2020 figures, it is way higher for the period, for 2020 it is 7000 excess death, last year, this year we have a negative excess death so that in all for 1,5 years I suspect an excess death of 5000-6000 here and decreasing.

Quote from Fm1

University of Iowa Led Observational Study Reveals Remdesivir Can Lengthen Hospital Stay & Not Contribute to Survival

https://trialsitenews.com/univ…t-contribute-to-survival/

University of Iowa Carver College of Medicine led a multi-site study finding that the only formally approved drug by the U.S. Food and Drug Administration (FDA) actually led to lengthier hospitalization duration, or was associated with such an observation. That is, the hospitalized patients infected with SARS-CoV-2, the virus behind COVID-19, were actually ready for discharge yet the hospital had to keep them until their 5 and 10-day remdesivir course was completed! Of course, all the while, the drug’s producer benefits (another utilized dose regimen) as well as the hospitals assuming they are compensated for the time. Led by Michael Ohl, MD, MSPH, associate professor of internal medicine with University of Iowa Health Care and a practicing doctor at Iowa City Veterans Affairs Health Care System, these findings raise some interesting questions. Again, the World Health Organization (WHO) has declared based on the results of the Solidarity study that remdesivir provides absolutely no benefit and, in fact, in much of the world, remdesivir isn’t administered for COVID-19. That’s very different in places like American where a biased stew of elements and factors play out to the background of billions accumulated by remdesivir’s maker, Gilead.

Despite the fact that the WHO has recommended against remdesivir for a long time now and some safety profile questions, remdesivir is probably the most administered COVID-19 drug in America. For all those that don’t remember, Gilead benefited from what appeared to be white-glove treatment from a pivotal Phase 3 clinical trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), and its director Dr. Anthony Fauci.

During the pivotal trial at the early onset of the pandemic, Fauci allowed for the changing of clinical trial endpoints, which helped ensure a good look at the drug. That worked—the FDA issued an emergency use authorization (EUA) in May and, later in October, it was formally approved. The WHO Solidarity findings came a few months later. TrialSite suggests that to Fauci and NIAID’s defense, there was enormous pressure at that time to produce some results to help fight a horrific, surging pandemic. But of course, this platform has systematically covered the seeming bias inherent in current research and development agencies and institutes, favoring expensive novel therapies over the potential for low-cost, generic yet potentially pragmatic early-onset care approaches.

Based on myriad encounters reviewing numerous studies, TrialSite suggests these findings indicate health systems, hospital administrators, and physicians need to consider remdesivir more carefully, exactly when and when it will not add to the patient’s benefit while reducing hospitalization.

The Study

The study was conducted at 123 Veterans Health Administration hospitals from the period of May 1 2020 to October 8, 2020.

In this study, the team, which included not only investigators from the University of Iowa but also the VA Bedford Health Care System, University of Massachusetts, Lowell, as well as VA Puget Sound Health Care System and University of Washington, Seattle, tracked 2,344 hospitalized adults with SARS-CoV-2 in 123 hospitals, demonstrating that remdesivir actually served to increase hospitalization duration length. However, the drug’s impact didn’t improve 30-day survival.

The study authors concluded that A) for a particular cohort in the study, the study drug didn’t associate with survival, however, did associate with lengthier hospitalization duration, and B) results suggest that routine remdesivir usage may be associated with lengthier hospital bed utilization but not improvements in patient survival.

Study Limitations

This study, like all, has some limitations. In this case, it’s an observational study, which is weighted less heavily than randomized controlled trials. Secondly, the observations only apply to 49.5% of the patients in the total group for whom the investigators could match to controls. These particular patients had a lower propensity for remdesivir treatment and less severe illness as compared to others, reports the authors. Finally, due to study data limitations, the authors couldn’t break down the subjects into more granular categories, thus showcasing which “subgroups of patients who may have been more likely to benefit from remdesivir treatment and from precisely emulating clinical trials.”

Lead Research/Investigator

Michael E. Ohl, MD, MSPH, University of Iowa, Carver College of Medicine, Iowa City Veterans Affairs (VA) Health Care System

Call to Action: See the study here.

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For once I agree with TrialSite that remdesivir does not seem good - and never seemed more than a hope. This one observational study does not add much to the weight of evidence though.

I disagree with the particularly unpleasant linkage of Fauci with bias. It is just nasty PR, with no evidence. I don't even agree the original US decision was biased. At the time it was worth trying. Remember also on remdesivir's side was its known activity as an anti-viral at feasible concentrations. Being expensive, just like being cheap, does not exclude a drug form consideration.

And note TrialSite's inconsistency. It does not apply the same skepticism to its pet favourite drugs.