The Playground

    10 Republican Congresspersons Send Demand Letter to FDA Commissioner: Release all COVID-19 Vaccine & Therapy Data Now


    10 Republican Congresspersons Send Demand Letter to FDA Commissioner: Release all COVID-19 Vaccine & Therapy Data Now
    www.trialsitenews.com


    A group of elected officials has sent a letter to the head of the U.S. Food and Drug Administration (FDA) to release all of the data the agency has in its possession on the COVID-19 approved products. Florida Republican Representative Bill Posey from Florida’s 8th Congressional district teamed with nine other congresspersons to demand access to key information.


    Writing Commissioner Robert Califf the elected officials first establish “Americans continued to evaluate the benefits and risks associated with these vaccines and therapeutics in the midst of the changing dynamics of the pandemic. Nothing is more important to physicians, parents, patients, public health officials, and elected officials than having access to as much information as possible when evaluating immediate and long-term responses to the pandemic.”


    Arguing that American society is so dependent on these FDA-regulated products the congresspersons argue that far more broad access is instrumental now and hence the letter. Upping the tone, the elected officials declare the FDA”s behavior “appalling” in withholding key COVID-19 vaccine and therapeutic data behind the agency’s firewall for over 18 months.


    Posey and colleagues demand “immediate release of all safety and efficacy data in its possession for EUA COVID-19 products which have now been approved by the FDA.” Moreover, the congresspersons are concerned that the FDA “allowed vaccine mandates while the products were under EUA and the data remained unavailable to the public.”


    Posey and colleagues remind the FDA that the vaccine manufacturers enjoy universal liability projection under the PREP Act while tens of billions of public money were spent on these companies. They emphasize that the FDA if it desires to maintain its “gold standard” brand ought to immediately support public access as transparency is fundamental to good science and any mandated drugs or vaccines.


    Who signed this letter?

    The following individuals signed the letter:


    Representative


    Congressional District


    Bill Posey


    8th District, Florida


    Vicky Hartzler


    4th District Missouri


    Mo Brooks


    5th District Alabama


    Madison Cawthorn


    11th District North Carolina


    Clay Higgins


    3rd District Louisiana


    Louie Gohmert


    1st District Texas


    Thomas Massie


    4th District Kentucky


    Ralph Norman


    5th District South Carolina


    Mary E. Miller


    15th District Illinois


    Thomas P. Tiffany


    7th District Wisconsin



    Interestingly, all of the signatories are Republican evidencing a severe partisan divide over concerns about the COVID-19 authorized products. This is a switch as typically in the past liberals from the Democratic Party paid more attention to such matters while Republicans were considered friendlier to big business

    Quote from Roseland67

    It’s like Linus waiting for the Great Pumpkin to rise out of the pumpkin patch on Halloween.

    No matter how many years they wait, the Great Pumpkin never comes.

    Sam, he ain’t coming, ever.

    Or Pinocchio waiting for his gold coins buried in the "miracle crop field" growing

    External Content www.youtube.com
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

    Sometimes on Rossilivecat there do appear almost empty posts from the magician like today:

    Quote

    2022-04-17 12:03 Andrea Rossi

    a

    Parallel to that we can see this on JONP:

    Same time, but switched to a well known sock puppet.

    My guess is that he (accidently?) posts some kind of draft and then fills in what the puppet has to say. The rossilivecat script grabs the draft and replaces it the next time it visits the blog.

    We all know that he cheats, but this might be real evidence.

    fourth booster for BigPharma $

    External Content www.youtube.com
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

    Covid-19: 'Small number' of Omicron XE cases in Northern Ireland
    There are 1,179 confirmed cases in the UK, with fewer than five in NI, the Public Health Agency says.
    www.bbc.co.uk


    A small number of cases of a new variant of the Omicron strain of Covid-19 have been discovered in Northern Ireland, according to the Public Health Agency (PHA).

    The new form of the virus, known as Omicron XE, is a recombinant of the Omicron BA.1 and BA.2 variants.

    The PHA said that 1,179 cases of XE have been confirmed in the UK so far.

    But, to date, fewer than five cases of the variant have been detected in Northern Ireland.

    Coming to a Tennessee Pharmacy Soon for COVID-19 & No Need for Prescription: Ivermectin


    Coming to a Tennessee Pharmacy Soon for COVID-19 & No Need for Prescription: Ivermectin
    www.trialsitenews.com


    On April 8 TS News reported that the Tennessee House and Senate voted overwhelmingly in support of making ivermectin available at the state’s pharmacies as a treatment for COVID-19 despite the opposition to the drug’s use for COVID-19 at the U.S. Food and Drug Administration (FDA) and general medical establishment (e.g. academic medical centers, licensing bodies, public health agencies). Now mainstream local media such as News4’s Tracy Kornet and Marius Payton introduce a report by Tosin Fakile discussing the reality that the drug should be available soon without a prescription via standing order.




    The Senate and House gave the final approval so how will it all work?

    While more steps are involved to make the drug available according to pharmacist Hetal Patel, the Tennessee Board of Pharmacy will make it accessible like Naloxone, a standing order protocol given the legislation has been passed.


    For example, in the State of Tennessee Naloxone, an overdose medication (Narcan) can be purchased online without a prescription and delivered by mail to Tennessee residents.


    According to Patel, a pharmacist “will need to counsel the patient.”


    Patel understands the move by the state legislature: “in one way it's good as I would rather have someone come and talk to me about their medication then just going buy and like a coop store where they have no idea what dose to take.”


    Yet, Dr. Parul Goyal, Assistant Professor of Medicine at Vanderbilt Health shared with the local media that the most recent study reveals that the data involving ivermectin's effectiveness at treating COVID-19 is unclear or inconclusive and thus they cannot say for sure ivermectin helps to treat COVID-19.


    Vanderbilt happens to be part of the Duke University, National Institutes of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-sponsored ACTIV-6 study investigating the use of ivermectin as a treatment for at least mild COVID-19.


    Goyal suggests taking the drug off-label can be dangerous without oversight due to side effects such as eczema, swollen lymph glands, diarrhea, etc. Since the data from the ACTIV-6 trial is still pending Goyal went on the record for local news that until there is scientific data evidence against COVID-19 she is “hesitant for anyone to take it without proper supervision.”


    Doctors and pharmacists are also reminded on this newscast that the state’s population has access to other approved treatments for COVID-19.


    Ivermectin proponents, often a small subset of critical access front-line physicians, have embraced ivermectin observing marked efficacy in their practices. A case series called ICON was conducted at Broward Health but as it wasn’t randomized the data isn’t considered the strongest evidence. 82 ivermectin studies have been conducted in humans during the pandemic, most of them showing positive results. However, the majority of these studies occurred in low-and middle-income countries such as Bangladesh and India, and known ivermectin critics such as epidemiologist Gideon Meyerowitz-Katz question the ethics of the underlying studies.


    On the other hand, TrialSite has chronicled many dozens of studies interviewing dozens of doctors and researchers who report positive findings. With a generally well-known safety profile if prescribed by a pharmacist that could be considered proper oversight alleviating the concerns of Dr. Goyal for example.


    The bill passed overwhelmingly in the senate and will offer pharmacists protection from civil liability and other legal or licensing board attacks if they provide the drug. The FDA has gone on the attack against the drug by writing letters to umbrella physician licensing and pharmacy board association warning them to police their members at the state level for espousing misinformation or prescribing drugs like ivermectin against COVID-19.


    A growing movement across America, and beyond, calls for medical choice and the push back of what civil libertarians consider overreach by national governments over the affairs of the patient and their physician or in this case pharmacist.


    See House Bill 2506 enacted by the General Assembly of the State of Tennessee making the off-label drug available for COVID-19.


    In Tennessee, a bill can be signed by the Governor, in this case, a Republican, Bill Lee, or vetoes or conversely allow it to become law without his signature. In veto scenarios, they can be overridden by a majority vote of the membership to which each body is entitled under the state Constitution. The press has been silent as to the status. TrialSite emailed Saturday the House Sponsor Susan Lynn. This media will update this article with any responses


    External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

    The Detroit Free Press and the Documenting COVID-19 project first reported on the mink cases in April 2021, after discovering details about them in Freedom of Information Act requests, and National Geographic confirmed last month that four cases with the same genetic mutations had been linked together.


    4 Michiganders with COVID-19 strain unique to mink were likely 1st U.S. spillover cases

    4 Michiganders with COVID-19 strain unique to mink were likely 1st U.S. spillover cases
    amp.freep.com



    Finding needed data proves elusive unless you file a freedom of information request. So much for transparency!

    So much for the CDC protecting these communities!

    Quote from Fm1

    Coming to a Tennessee Pharmacy Soon for COVID-19 & No Need for Prescription: Ivermectin

    Have to chuckle that the NBC video news clip kept showing packs of ivermectin horse paste on shelves, as if that's going to be in Tennessee pharmacies soon. The medical and media establishments will fight ivermectin as long as they can.

    Quote from sam12

    Rossi says Battery charging best use for ECat-SKLep.

    Frank posts.


    https://e-catworld.com/2022/04…ep-is-charging-batteries/

    Yeah, and the funny thing is, he himself asked. :D


    Quote

    2022-04-18 08:37 Josephine

    Dear Dr Andrea Rossi,

    Based on the experiments you are making, which is the best and easiest use of the Ecat SKLep that you envision ?

    All the best,

    J.

    The sock puppet army added quite a few new names recently.


    2022-04-18 09:05 Kurt

    2022-04-18 08:37 Josephine

    2022-04-17 08:24 Ann

    2022-04-17 03:39 Michele

    2022-04-16 14:43 Yuri

    The US-headquartered pharmaceutical company Catalent has bought Vaccine Manufacturing and Innovation Centre (VMIC) that is under construction in Oxfordshire, UK. The government-supported facility was intended to be the country’s first non-profit vaccine producer. Catalent plans to invest £120 million to finish building the centre, which is expected to employ more than 400 people when it eventually opens.

    VMIC was founded in 2018 by the University of Oxford, Imperial College and the London School of Hygiene & Tropical Medicine, backed by £66 million from the UK government in addition to support from three industrial partners. Originally scheduled to open in 2022, the centre was to develop vaccines for global distribution and preparing the UK against future pandemics.

    In May 2020, the government announced a further £131 million investment to speed up construction of the site, aiming to bring it online by mid-2021 to help with the Covid-19 response. However, with numerous pharmaceutical companies now producing coronavirus vaccines on a massive scale, government sources believe that VMIC’s surge capacity is no longer required.

    ‘Our priority is to complete construction as soon as possible to be able to commence customer programs in 2022,’ said Catalent’s president for biotherapeutics Mike Riley in a statement. ‘We will then integrate its capabilities within our existing network of biologics facilities across Europe to offer a flexible range of manufacturing, technology and development solutions for the pipeline of thousands of development programmes currently underway.’

    Critics of the sale have accused the government of neglecting biological threats, noting that vaccine manufacturing capabilities should be at the heart of national security strategy. Writing in the British Medical Journal, a group of medical experts have described VMIC as ‘the jewel in the crown’ of the UK’s Covid-19 response. The decision to sell it off is ‘difficult to justify on strategic, public health, economic, or reputational grounds’, they argued.

    India Is Stalling the W.H.O.’s Efforts to Make Global Covid Death Toll Public
    The agency has calculated that 15 million people have died as a result of the pandemic, far more than earlier estimates, but has yet to release those numbers.
    www.nytimes.com


    India Is Stalling the W.H.O.’s Efforts to Make Global Covid Death Toll Public

    The agency has calculated that 15 million people have died as a result of the pandemic, far more than earlier estimates, but has yet to release those numbers.


    An ambitious effort by the World Health Organization to calculate the global death toll from the coronavirus pandemic has found that vastly more people died than previously believed — a total of about 15 million by the end of 2021, more than double the official total of six million reported by countries individually.


    But the release of the staggering estimate — the result of more than a year of research and analysis by experts around the world and the most comprehensive look at the lethality of the pandemic to date — has been delayed for months because of objections from India, which disputes the calculation of how many of its citizens died and has tried to keep it from becoming public.


    More than a third of the additional nine million deaths are estimated to have occurred in India, where the government of Prime Minister Narendra Modi has stood by its own count of about 520,000. The W.H.O. will show the country’s toll is at least four million, according to people familiar with the numbers who were not authorized to disclose them, which would give India the highest tally in the world, they said. The Times was unable to learn the estimates for other countries. . . .

    This is exaggerating at its highest WHO claims 4 million not 15 million. New York Times needs to check facts!!!


    India objects to WHO's methodology after report claims 4 million Covid deaths

    India objects to WHO's methodology after report claims 4 million Covid deaths
    The New York Times, in its article titled 'India Is Stalling WHO's Efforts to Make Global Covid Death Toll Public', claimed the WHO estimate will show that…
    www.hindustantimes.com


    India has objected to the methodology used by the World Health Organization (WHO) for estimating the deaths caused by coronavirus disease (Covid-19) in the country. The ministry of health and family welfare said in a statement that the same mathematical model cannot be used to calculate the Covid mortalities for a large country like India, geographically and population-wise, and for other countries with a smaller population.

    Imperfect messengers? An analysis of vaccine confidence among primary care physicians


    Imperfect messengers? An analysis of vaccine confidence among primary care physicians
    Growing narratives emphasize using primary care physicians as leaders in efforts to promote COVID-19 vaccination among the vaccine hesitant. Criticall…
    www.sciencedirect.com


    Highlights

    •

    10.1% of primary care physicians (PCPs) do not agree vaccines are safe.


    •

    9.3% of PCPs do not agree that vaccines are effective.


    •

    8.3% of PCPs do not agree that vaccines are important.


    •

    Physician confidence in COVID-19 vaccines varies across vaccines.


    •

    A troubling proportion of PCPs lack high levels of vaccine confidence.



    Abstract

    Background

    Growing narratives emphasize using primary care physicians as leaders in efforts to promote COVID-19 vaccination among the vaccine hesitant. Critically however, little is known about vaccine confidence among primary care physicians themselves. The objective of this study was to assess both physician confidence that in general, vaccines are safe, effective, and important, as well as physician confidence in each COVID-19 vaccine in the United States.


    Methods

    We rely on data from a national survey of primary care physicians conducted from May 14-May 25, 2021. We assess the influence of demographic, social, and political factors on physician beliefs that in general, vaccines are safe, effective, and important, as well as physician confidence in the safety of the Moderna, Pfizer, and Johnson & Johnson COVID-19 vaccines.


    Results

    10.1% of primary care physicians do not agree that, in general, vaccines are safe, 9.3% do not agree they are effective, and 8.3% do not agree they are important. While 68.7% of physicians were ‘very confident’ in the safety of the Moderna vaccine and 72.7% were ‘very confident’ in the safety of the Pfizer vaccine, only 32.1% of physicians were ‘very confident’ in the safety of the Johnson & Johnson COVID-19 vaccine.


    Conclusion

    A troubling proportion of primary care physicians lack high levels of vaccine confidence. These physicians may not be well positioned to actively promote COVID-19 vaccination even as political and media narratives push physicians to lead this effort. Interventions aimed at improving vaccine confidence among some physicians may be needed so that all physicians can fulfill needed roles as trusted vaccine communicators.

    Quote from JedRothwell

    The W.H.O. will show the country’s toll is at least four

    Of course they will count in all the people that did starve to death due to lock down. Also the ones that no longer could get live saving drugs. This is how the free masons work. Create a narrative that fits their wishes.


    Fact is: India did the best of all western countries. The Omicron wave peek was 1/20 of the western figures. And best:: Thanks to Ivermectin++ Omicron is history since more than 2 weeks...


    But this story will not help sell fake vaccines.

    Quote from Fm1

    This is exaggerating at its highest WHO claims 4 million not 15 million. New York Times needs to check facts!!!

    They have the facts right. There are different totals within different parts of the WHO. They compile totals reported by health ministries. That comes to 6.2 million (the numbers shown at worldmeters and Johns Hopkins). The WHO also has a Technical Advisory Group, which estimates 15 million. Quote:


    To try to take the true measure of the pandemic’s impact, the W.H.O. assembled a collection of specialists including demographers, public health experts, statisticians and data scientists. The Technical Advisory Group, as it is known, has been collaborating across countries to try to piece together the most complete accounting of the pandemic dead.


    The thing is, some national health ministries report reliable numbers. I am sure the ones in the UK, the U.S., Canada or Japan are accurate. But others severely underestimate the totals, either deliberately, or because they simply cannot get the data. I am sure the Indian ministry is wrong. All the experts in India say that. As noted here previously, for some districts, they reported no deaths at all for any reason, for months. As the Times noted, for some sub-Saharan African countries, they do not even collect the data. It is all guesswork.


    Calculating excess deaths globally is a complex task. Some countries have closely tracked mortality data and supplied it promptly to the W.H.O. Others have supplied only partial data, and the agency has had to use modeling to round out the picture. And then there is a large number of countries, including nearly all of those in sub-Saharan Africa, that do not collect death data and for which the statisticians have had to rely entirely on modeling.

Subscribe to our newsletter

It's sent once a month, you can unsubscribe at anytime!

View archive of previous newsletters

* indicates required

Your email address will be used to send you email newsletters only. See our Privacy Policy for more information.

Our Partners

Supporting researchers for over 20 years
Want to Advertise or Sponsor LENR Forum?
CLICK HERE to contact us.