The Playground

  • Open Letter to the FDA from Top Doctors & Scientists—Current COVID-19 Vaccine Performance Data Not Sufficient



    A former chief scientist with the U.S. Food and Drug Administration (FDA) as well as prominent physician-investigators from University of Pennsylvania Perelman School of Medicine, Memorial Sloan Kettering Cancer Center, Mayo Clinic, and dozens of other top academic medical centers recently wrote an open letter to both Dr. Robert Califf, MD and Peter Marks, MD, Ph.D. of the FDA urging them to pressure vaccine developers such as Pfizer and Moderna to do a better job understanding vaccine efficacy in the form of T-cell response during clinical trials plus antibody response. After all, this is vital information for health authorities and the medical establishment to better assess not only vaccine efficacy but importantly, guide options regarding ongoing protection against COVID-19—for variants now and into the future. The COVID-19 vaccines’ durability has raised growing questions among physicians and medical researchers while TrialSite has been chronicling challenges with vaccine performance since the summer of 2021 when the Delta variant of concern exposed vulnerabilities with the vaccines.


    While recognizing the “remarkable advances” made by the COVID-19 vaccines, the prominent group of doctors and medical researchers remind the FDA’s two top leaders just how much we don’t know about vaccine-induced immune response to SARS-CoV-2, the virus behind COVID-19.


    Although the FDA formally approved the Pfizer vaccine (Comirnaty) while still, only the BN162b2 version of the product under emergency use authorization (EUA) is in use in America, TrialSite suggested over the last couple of years evidence for politicization of the pandemic which may have compromised the FDA and CDC, something possibly verified in a bombshell General Accounting Office (GAO) report all but ignored by mainstream media. See TrialSite’s accounting of that report in “Bombshell: U.S. General Accounting Office Finds Evidence of Political Interference Occurring at CDC & FDA During COVID-19.”


    With vaccine mandates forcing tens of thousands—if not hundreds of thousands of people including first responders and health care professionals out of hir jobs (those that for whatever reason opted to not receive the vaccine) a fundamental premise underlying such extreme measures was that not only was the vaccine of the highest quality and durability but that it would control transmission. While the COVID-19 vaccines have demonstrated that at least for a duration they protect against severe infection and death, with Omicron came a high breakthrough infection rate and corresponding transmissibility. Now mainstream media via the Washington Post recognized growing breakthrough mortality among the elderly and immunocompromised.


    But evidence of durability challenges materialized by last summer with the Delta variant of concern. TrialSite covered multiple studies evidencing growing challenges including waning effectiveness in the face of an ever-mutating pathogen.


    Prominent participants in the medical establishment are waking up to the need for more comprehensive performance data as evidenced in this recent letter as the authors declared at the opening of the correspondence:


    “To date, we lack a clear-cut correlate of protection for h SARS-CoV-2 vaccines and the assessment of the adaptive immune response to SARS-CoV-2 infection and vaccination has largely focused on antibodies (Abs), with much less emphasis on the T-cell response despite a likely role in protection from severe disease.

  • But just in February, the DailyMail reported that COVID-19 vaccine injury claims were approaching 110 million pounds with up to 920 vaccine injury compensation applications. So just in two months, those claims have risen by another 280 severe injuries or death claims. The DailyMail is British-owned and is the highest circulated news in the UK.

    God help us if folks in the US view the Daily Mail as the main vehicle of unbiassed news coverage in the UK!


    Daily Mail
    QUESTIONABLE SOURCE A questionable source exhibits one or more of the following: extreme bias, consistent promotion of propaganda/conspiracies, poor or no
    mediabiasfactcheck.com


    The Independent is better, but still not great:

    The Independent UK
    LEFT-CENTER BIAS These media sources have a slight to moderate liberal bias.  They often publish factual information that utilizes loaded words (wording
    mediabiasfactcheck.com


    However you might want to try, for more factual reporting in the UK, the Times:

    The Times UK and The Sunday Times
    RIGHT-CENTER BIAS These media sources are slightly to moderately conservative in bias. They often publish factual information that utilizes loaded words
    mediabiasfactcheck.com


    which comes out best of all the major UK broadsheets for factual reporting.


    THH

  • THH is not to be outdone by the ambitions of the new Ministry of Truth in the US.

    Thank goodness we are about to be saved from mis and dis information.


    Then there is the matter of that pesky Eudravigilance database, which reports the following for the EU (and which also incorporates UK data I think).



    To give the above numbers some connection to real human experience, one could check out any number of websites such as https://www.realnotrare.com

  • @maybe Brook trout

    That's what all this was about back in the day, wave tubes into open cavity's with fuel as balls within the case. long way to go..

    Well, you may have the apparatus on your kitchen counter. It's called a microwave oven. But what is supposed to be the result. I imagine microwaves can excite various resonances in materials, but so might much lower frequencies.


    You like to play with this stuff. Go read Joseph Papp's patent and try duplicate his engine. You might succeed. He had all sorts of stuff in that engine. Even thorium.

  • @THHuxelynew


    You miss the point of my posts. I'm not interested in the plethora of theories circulating here about nuclear reactions but rather experimental results concerning interactions between alpha particles and singly ionized helium 4 atoms I mention SLAC because it is the gold standard for studying such interactions. That is the first step to lenr from the alpha chain. What is the half life of the alpha particle - singly ionized He4 pair? The valence electron should moderate the interaction giving it more stability and longer life.

  • long COVID solved


    Coronavirus found in patients’ stool 7 months after infection

    Long COVID: Viral infection may persist in gut for up to 7 months
    New research sheds more light on long COVID, as it finds virus fragments in patients’ stool 7 months after coronavirus infection.
    www.medicalnewstoday.com


    A study has found fragments of RNA from SARS-CoV-2 in patients’ stools up to 7 months after their COVID-19 diagnosis.

    The presence of viral RNA in the samples correlated with gastrointestinal symptoms, such as abdominal pain, nausea, and vomiting as well as runny nose, headache, and body aches.

    This study was unable to provide direct evidence of active viral infection, but other lines of evidence suggest that it may occur.

    Future research will investigate possible links between ongoing viral infection and the community of microorganisms that live in the gut, or “gut microbiota.”


    Anemia and iron deficiency in gastrointestinal and liver conditions


    Anemia and iron deficiency in gastrointestinal and liver conditions
    Anemia and iron deficiency in gastrointestinal and liver conditions
    www.wjgnet.com


    Abstract

    Iron deficiency anemia (IDA) is associated with a number of pathological gastrointestinal conditions other than inflammatory bowel disease, and also with liver disorders. Different factors such as chronic bleeding, malabsorption and inflammation may contribute to IDA. Although patients with symptoms of anemia are frequently referred to gastroenterologists, the approach to diagnosis and selection of treatment as well as follow-up measures is not standardized and suboptimal. Iron deficiency, even without anemia, can substantially impact physical and cognitive function and reduce quality of life. Therefore, regular iron status assessment and awareness of the clinical consequences of impaired iron status are critical. While the range of options for treatment of IDA is increasing due to the availability of effective and well-tolerated parenteral iron preparations, a comprehensive overview of IDA and its therapy in patients with gastrointestinal conditions is currently lacking. Furthermore, definitions and assessment of iron status lack harmonization and there is a paucity of expert guidelines on this topic. This review summarizes current thinking concerning IDA as a common co-morbidity in specific gastrointestinal and liver disorders, and thus encourages a more unified treatment approach to anemia and iron deficiency, while offering gastroenterologists guidance on treatment options for IDA in everyday clinical practice.


    Key Words: Iron deficiency anemia, Gastrointestinal bleeding, Nonsteroidal anti-inflammatory drugs, Gastritis, Infection, Bariatric surgery, Celiac disease, Gastrointestinal neoplasm, Chronic hepatitis, Non-alcoholic fatty liver disease


    Core tip: Iron deficiency anemia (IDA) frequently originates in the gastrointestinal (GI) tract and is a common cause of patient referral to gastroenterologists. Guidelines for the management of IDA in GI conditions are lacking. Symptoms such as fatigue and impaired exercise capacity should prompt a diagnostic work-up for anemia (hemoglobin), iron status (transferrin saturation, ferritin) and inflammation (C-reactive protein). Treatment of IDA should aim to restore normal hemoglobin levels, red cell indices and iron status. Intravenous administration is the preferred iron treatment in patients with chronic GI bleeding, patients being unresponsive or intolerant to oral iron and patients requiring rapid hemoglobin correction

  • @maybe Brook trout

    Well, you may have the apparatus on your kitchen counter. It's called a microwave oven. But what is supposed to be the result. I imagine microwaves can excite various resonances in materials, but so might much lower frequencies.


    You like to play with this stuff. Go read Joseph Papp's patent and try duplicate his engine. You might succeed. He had all sorts of stuff in that engine. Even thorium.

    I stole it off a church wall in Jerusalem as I thought I recognized it. build the model thinking it would put thought out.

    I'm just tinkering as something to do as I wait.

  • You obviously didn't read the latest on paxcrap

    I have read enough to know that many leading experts worldwide think that Paxlovid is effective and safe. Perhaps they are wrong, but I am sure they are not all engaged in a conspiracy. No doubt you know of some experts who disagree. That does not mean they are right.


    But you are changing the subject. You asked, indignantly, "why is the president telling doctors what to prescribe?" Answer: Because that is his job. The Federal government plays a huge role in healthcare, and in the development and certification of drugs. It has played this role for over a century. I am sure you know this. So why are you are asking this? You know darn well why he is telling doctors what to prescribe. You should know that he is not doing this to further a nefarious scheme, but because that is what Federal experts have recommended.

  • I was also building types of magnetrons from scratch from a 3D printer and sand castings at the time for resonances and frequencies.

    It was interesting.

    and moving the wave

    With a fuel ball feeding a cathode anode form under the magnetron above the fuel ball back feeding the system ect.

    electrolytes bla bla bla.

  • I have read enough to know that many leading experts worldwide think that Paxlovid is effective and safe. Perhaps they are wrong, but I am sure they are not all engaged in a conspiracy. No doubt you know of some experts who disagree. That does not mean they are right.


    But you are changing the subject. You asked, indignantly, "why is the president telling doctors what to prescribe?" Answer: Because that is his job. The Federal government plays a huge role in healthcare, and in the development and certification of drugs. It has played this role for over a century. I am sure you know this. So why are you are asking this? You know darn well why he is telling doctors what to prescribe. You should know that he is not doing this to further a nefarious scheme, but because that is what Federal experts have recommended.

    How do you know I was asking indignantly, as a matter of fact I was asking a simple question. The president is promoting a drug that just might increase the spread thru relapse. Seems pretty stupid to me but he listens to the so called experts who must of simply forgotten to tell old joe it might have a problem. I bet sales have gone up since old joe promotion, and we just bought 6 million more doses payed for by the American tax payers.


    Yes, Relapses After Paxlovid Happen — Now What

    Yes, Relapses After Paxlovid Happen -- Now What?
    Around two weeks ago, one of my long-term, very stable patients with HIV called me saying she’d just been diagnosed with COVID-19. Over 60 with hypertension,…
    blogs.jwatch.org


    Around two weeks ago, one of my long-term, very stable patients with HIV called me saying she’d just been diagnosed with COVID-19. Over 60 with hypertension, and overweight, she qualified for nirmatrelvir/r (Paxlovid) under the Emergency Use Authorization (EUA), and took it without problem.


    (Certain details changed for confidentiality.)


    In fact, she started to improve within 24 hours of the first dose. Complained a bit about the metallic taste, but was thrilled at this rapid recovery.


    She then contacted me again a week later, saying she’d relapsed. More nasal congestion, cough, and fatigue — not as bad as when the illness started, but unmistakably a relapse. Not only that, the home antigen test, which started out as a dark line at the outset, became a barely discernible line after the treatment, and now was clearly positive again.


    Her biggest concern was getting back out in the world without infecting someone. She really wasn’t that sick; she just wanted advice about when she could return to work and start socializing again.


    “Avoid close contact with others until that test clears,” I said. (Which it did a few days later, and she completely recovered.) But certainly the whole thing was a head-scratcher for both of us.


    Turns out these relapses do occur; this was just the first time I saw it. The investigators from Pfizer observed them in their clinical trial EPIC-HR, and reported it to the FDA. Take a look at this figure from their study, which was not included in the NEJM paper, but did appear in an FDA report:

  • pointing the opening up vs down.. something to think about if you have high moisture in the air.


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  • Mark - do you really believe this? No - of course you don't. Eudravigilance is the EU equivalent of VAERS.


    Remember the VAERS issues - settled ages ago when I linked proper analysis which blew out of the water the fake multipliers used by the antivaxxers (they were provably fake). Well, surprise, surprise, the EU has a similar system that allows every event that might be an adverse reaction to be reported.


    Basically, that means every serious illness which is not open and shut some obvious other cause. Heart disease - is it the vaccine, or just... heart disease. People with no cardiac history die of heart attacks all the time.


    Have you looked at the background death rate expected from the 440 million EU population and worked out how many deaths or serious events you would expect? No - of course not - the antivaxxers do not do this, because it proves uncomfortable to their case. If you take 3 vaccine doses and a 4 weeks window after each one you expect to have 12 weeks/80 years * 440 million = 440*0.2/80 million ~ 1 million deaths that could be vaccine-related because of temporal coincidence. Just because people die. Of course only a few of those get reported - the problems is that many more get reported for a new vaccine than for a very old well understood vaccine.


    VAERs, and its EU equivalent - are uniquely inaccurate ways to measure the level of adverse reactions, because they depend on the reporting level which can be either over or under the real level of adverse events. For new vaccines - it will be higher. Interestingly in the US high VAERS spike are correlated with legal cases involving vaccines...


    Whether somone reports a probably not related death to VAERS, or eudravigilance, is uniquely sensitive to how they feel about vaccine safety and of course the rate will be higher for any less well established vaccine.


    Which is as it should be.


    Unfortunately the antivaxxers - I use this term advisedly as a deep insult, and am happy to apply it to those here who deliberately pay no attention to repeated clear explanations (from me and many others) of why these antivaxxers memes are disinformation - abuse this data and get believed by those emotionally wired to doubt mainstream science - or indeed mainstream anything.








    Fact Check-EudraVigilance does not say COVID-19 vaccines have killed tens of thousands of people
    Social media users have claimed a European database of suspected adverse drug reactions has revealed tens of thousands of people have died as a result of…
    www.reuters.com


    Social media users have claimed a European database of suspected adverse drug reactions has revealed tens of thousands of people have died as a result of COVID-19 vaccines. However, this is a misrepresentation of what the database is and what it shows.

    Hundreds of people have engaged with memes online that claim to show results of a report on the Eudravigilance database, which covers the European Economic Area (EEA) – and is the European equivalent of Britain’s Yellow Card scheme.

    One meme, posted to Facebook on Oct. 27, claims Eudravigilance shows COVID-19 vaccines caused 2.5 million “injuries”, more than 27,000 of which were fatal (here).

    Another from Nov. 1 claimed COVID-19 vaccine injuries had risen to 2.6 million, while deaths climbed above 28,000 (here). A third from Nov. 11 said injuries rose another 100,000, while deaths topped 29,000 (here).

    Many of these claims come from Health Impact News, a website that describes itself as publishing stories “the mainstream media seldom covers”. It regularly posts pieces that criticise COVID-19 vaccines, along with claims that figures provided by the EudraVigilance database are confirmed adverse reactions to the shots (here).

    Reuters presented the claims to the European Medicines Agency (EMA), which said: “The data circulating in many articles and social media posts are incorrect.”

    Medicines regulatory authorities and pharmaceutical companies across the EEA are required to submit reports of suspected adverse reactions to Eudravigilance from their respective member states (here).

    The database emphasizes that each report describes an effect that happened either “following administration of, or treatment with, a medicine”. This is not confirmation of a causal link between the two (here and here).

    “The collection of all reports of suspected adverse drug reactions is one of the pillars of the EU safety monitoring system,” the EMA told Reuters by email. “Spontaneous reporting serves as a tool to detect unusual or unexpected issues related to the use of a vaccine which may require further investigation and risk assessment.

    “Reports of suspected adverse drug reactions (ADRs) alone are rarely sufficient to prove that a certain suspected reaction has been caused by a specific medicine, i.e. a COVID-19 vaccine. EMA’s detailed assessments take into account all available data from all sources (clinical trials, medical literature, observational studies, etc.) to draw a robust conclusion on the safety of the vaccine.

    “For most medicines and vaccines, the vast majority of suspected side effects are not eventually confirmed as side effects. For cases with fatal outcome, it is difficult to state with certainty the real cause of death even if all data, including autopsy results, are available. Please note that it is not EMA’s role to adjudicate the cause of death.”


    If I spend little time on this thread it is because only maybe 5 people other than me contribute here on the topic of vaccines, and most of them are died in the wool antivaxxers. Whether uninterested in science, unable to process anything anyone else argues, and therefore uniquely likely to go down rabbit holes, or just very easily deceived, it makes little difference. They will not benefit from clear logical explanations, however clear or compelling.


    So it is an exercise in futility to attempt to address falsehoods - much as I have a very strong motivation to do that.


    THH

  • How do you know I was asking indignantly, as a matter of fact I was asking a simple question. The president is promoting a drug that just might increase the spread thru relapse. Seems pretty stupid to me

    That is true of all antibacterial and antiviral drugs.


    Methinks thou dost protest too much. And involving politics just prevents anyone from the US acting in other than a partisan way on this question. Leave off it.

  • long COVID solved


    A study has found fragments of RNA from SARS-CoV-2 in patients’ stools up to 7 months after their COVID-19 diagnosis.

    The presence of viral RNA in the samples correlated with gastrointestinal symptoms, such as abdominal pain, nausea, and vomiting as well as runny nose, headache, and body aches.

    This study was unable to provide direct evidence of active viral infection, but other lines of evidence suggest that it may occur.

    This data is certainly interesting - but one thing the last two years has taught anyone of sense who has been paying attention is that initial indications do not always pan out, and one study does not a summer make.


    Anyway, in this case, if covid remains alive somewhere in the body for 7 months the solution here must go with understanding how that is happening.


    And it is a big if, as the text above says.

  • Now for something different...


    All of life’s nucleic acids could have extraterrestrial origins


    All five nucleobases of RNA and DNA have been discovered in meteorites for the first time. These chemicals are essential ingredients for life on Earth and several purines and also two pyrimidines – thymine and cytosine – not previously detected in meteorites were found.


    The findings come from an analysis of three carbonaceous meteorites, known to be rich in organic molecules. The discovery ‘provides additional support for the theory that the delivery of these compounds to Earth by meteorites may have played a role in the emergence of genetic functions for early life’, according to astrobiologist Daniel Glavin at Nasa, which provided one of the meteorites.


    All of life’s nucleic acids could have extraterrestrial origins
    All five nucleobases of RNA and DNA found in three meteorites
    www.chemistryworld.com

  • Turns out these relapses do occur; this was just the first time I saw it. The investigators from Pfizer observed them in their clinical trial EPIC-HR, and reported it to the FDA. Take a look at this figure from their study, which was not included in the NEJM paper, but did appear in an FDA report:

    This only says one thing. The drug does not work. Or a bit more optimistic might work sometimes. But it is the same with seat belts. These also sometimes strangle drivers to death but far more often they save its live...

  • Long haulers battling hair loss due to COVID; North Texas doctors working on treatments


    https://www.wfaa.com/amp/article/news/health/coronavirus/you-saw-it-coming-out-north-texas-woman-deals-with-hair-loss-while-battling-long-covid-meets-with-doctors-for-solution/287-3aa5cf0f-c65e-4d3f-8130-6a289c9dafe7


    Long haulers battling hair loss due to COVID; North Texas doctors working on treatments

    A month after her COVID diagnosis, 43-year-old Adriana Cesar noticed clumps of hair falling out.

    Author: Sonia Azad

    Published: 4:52 PM CDT May 2, 2022

    Updated: 4:52 PM CDT May 2, 2022

    DALLAS — According to the Centers for Disease Control and Prevention (CDC), more than half of Americans have been infected by coronavirus.


    Long-term side effects are wide-ranging and, in some cases, devastating.


    One common complaint from long haulers is hair loss.


    "I didn't lose taste or smell, it just really affected my body," said Adriana Cesar, who tested positive for COVID at the beginning of 2022.


    Vitamin D Deficiency and Hair Loss: Everything You Need to Know

    https://www.webmd.com/connect-…nd-hair-loss#:~:text=Here's%20how%20being%20low%20on,including%20low%20vitamin%20D%20levels.


    Can Vitamin D Deficiency Cause Hair Loss?

    Vitamin D is metabolized in the skin by keratinocytes. These are skin cells that process keratin, a protein in hair, nails, and skin. When the body doesn’t have enough vitamin D, keratinocytes in hair follicles have trouble regulating hair growth and shedding.


    “There is a link between vitamin D deficiency and alopecia, and it is often one of the common causes of thinning hair or hair loss in men or women,” Arielle Levitan, MD, an internal medicine physician in Chicago, tells WebMD Connect to Care.


    A 2017 review in the International Journal of Molecular Sciences found that low vitamin D levels have been linked to:


    Telogen effluvium, or excess hair shedding

    Alopecia areata, an autoimmune disorder where hair falls out in clumps

    Female pattern hair loss

    A 2019 study in the Indian Dermatology Online Journal found vitamin D deficiencies could worsen hair loss over time. And a 2016 study from the International Journal of Trichology found that among younger people with hair loss, women showed greater vitamin D deficiency.

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