{"id":6941,"date":"2024-07-26T10:38:12","date_gmt":"2024-07-26T10:38:12","guid":{"rendered":"http:\/\/humanityandearth.com\/wp\/?p=6941"},"modified":"2024-09-12T11:14:35","modified_gmt":"2024-09-12T11:14:35","slug":"the-fdas-disastrous-war-against-sleep","status":"publish","type":"post","link":"http:\/\/humanityandearth.com\/wp\/?p=6941","title":{"rendered":"The FDA’s Disastrous War Against Sleep & adverse events of Covid-19"},"content":{"rendered":"\n
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Last month\u2019s tranche of documents showed that in late 2021 and early 2022, FDA and NIH officials privately expressed concerns about the growing rate of adverse events<\/a> related to the COVID-19<\/a> vaccines<\/a> \u2014 concerns that reached high-level FDA officials.<\/h4>\n\n\n\n

Despite public statements by government officials affirming the safety and efficacy of COVID-19 vaccines in early 2022, documents obtained by Children\u2019s Health Defense (CHD) reveal that, at that time, public health officials were increasingly concerned about vaccine-related adverse events.<\/p>\n\n\n\n

The 300 pages of documents<\/a> released on Aug. 22 contain private correspondence from 2021 and early 2022 between U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials, and emails from vaccine-injured individuals to NIH scientists.<\/p>\n\n\n\n

CHD requested the documents via a Freedom of Information Act (FOIA) request<\/a> in 2022. In April 2023, CHD sued the NIH<\/a> to obtain the records after the agency failed to respond. In an October 2023 settlement, the NIH agreed<\/a> to produce 7,500 pages<\/a> of documents at a rate of 300 pages per month.<\/p>\n\n\n\n

Last month\u2019s tranche of documents showed that in late 2021 and early 2022, FDA and NIH officials privately expressed concerns about the growing rate of adverse events<\/a> related to the COVID-19<\/a> vaccines<\/a> \u2014 concerns that reached high-level FDA officials.<\/p>\n\n\n\n

A Jan. 24, 2022, email (pages 239-240) to Dr. Janet Woodcock<\/a>, the FDA\u2019s principal deputy commissioner of food and drugs, and Peter Marks, M.D., Ph.D.<\/a>, director of the FDA\u2019s Center for Biologics Evaluation and Research, alerted them to the existence of \u201cscientific data\u201d regarding adverse events.<\/p>\n\n\n\n

The email, titled \u201cImpromptu Meetup\u201d and sent by an individual whose name is redacted, stated:<\/p>\n\n\n\n

\u201cWe are in [Washington] DC the remainder of today and tomorrow. Some of our epidemiologists happen to be in town as well and would like to have the opportunity to review with you the scientific data they have.<\/p>\n\n\n\n

\u201cAlso checking in to see what progress has been made with our researchers?\u201d<\/p>\n\n\n\n

In a reply later that day, Woodcock said, \u201cWe are evaluating the data and analyses that have been done on adverse events after vaccination, particularly neurologic AE\u2019s\u201d (adverse events).<\/p>\n\n\n\n

However, she added that the FDA was \u201cnot having in person meetings\u201d at that time but stated that \u201csomething could be set up for a discussion between the scientists but it would need to be scheduled to ensure the right people attend.\u201d She did not clarify who the \u201cright people\u201d would be.<\/p>\n\n\n\n

On the same day, Marks also responded to the email, stating that the FDA has \u201cconnected with\u201d NIH researcher Dr. Avindra Nath<\/a> \u2014 who was studying vaccine-related adverse events \u2014 and was \u201calso working through contacting other physicians as well.\u201d<\/p>\n\n\n\n

Marks added that he \u201csent a note to our pharmacovigilance group to see if they can free up time today or tomorrow\u201d but said that \u201csetting up a virtual meeting at some point in the near future when there is more time to plan participants and the agenda may make sense.\u201d<\/p>\n\n\n\n

There is no indication as to whether this meeting ultimately took place.<\/p>\n\n\n\n

The emails followed just months after another NIH scientist, Farinaz Safavi, M.D., Ph.D.<\/a>, of the NIH Division of Neuroimmunology and Neurovirology, appeared to acknowledge the potential dangers of COVID-19 boosters.<\/p>\n\n\n\n

In a Sept. 30, 2021, email (page 129), Safavi told a vaccine-injured individual, \u201cWe do not have any data to suggest for or against booster shot [sic] but the consensus among our team is not to take if patient develop [sic] significant neurological complications post vaccine.\u201d<\/p>\n\n\n\n

The individual emailed Safavi earlier that day asking whether it was advisable to receive the then-new COVID-19 booster, despite saying that \u201cnothing has really changed\u201d regarding their symptoms.\u201cI think my ears are still off, but I have gotten used to it.\u201d<\/p>\n\n\n\n

The injured person previously contacted Safavi earlier in 2021 complaining about injuries sustained following vaccination \u2014 describing in a March 26, 2021, email (page 136), \u201csevere paresthesias<\/a> in my face and scalp and tongue and chest band tightness,\u201d and \u201csevere muscle spasms in my scalp and jaw and even my gums and teeth hurt.\u201d<\/p>\n\n\n\n

Vaccine injury victims felt \u2018very betrayed\u2019<\/strong><\/p>\n\n\n\n

But while some people injured by the vaccines received replies and advice from NIH scientists, the latest documents showed that many others received no such replies. Some sent desperate emails to NIH scientists asking for help or an update.<\/p>\n\n\n\n

For instance, in a Jan. 14, 2022, email (pages 234-235) to Nath, a vaccine-injured person praised Nath for his previous work helping the vaccine-injured, but then noted that he and other NIH scientists subsequently abandoned them. The email stated, in part:<\/p>\n\n\n\n

\u201cDr. Safavi left a vaccine injured chat last September, something strange was going on. The active engagement from the spring and summer was replaced with distance and vague responses, then nothing. But then some people get telehealth visits, and vague responses \u2026 and others are told \u2018there is no research\u2019 and that\u2019s it for them.<\/p>\n\n\n\n

\u201cI am sure you would understand now why the hundreds+ who were turned down for any assistance are now extremely upset after waiting for so long \u2026 many feel very betrayed. They have been waiting and waiting, all while suffering every single day. \u2026 The conversation isn\u2019t happening. They are dying.\u201d<\/p>\n\n\n\n

Marks and other FDA officials appear to have met with vaccine-injured individuals a few months prior, according to an Aug. 18, 2021, email sent to Nath (page 283). In that email, the vaccine-injured person wrote:<\/p>\n\n\n\n

\u201cOur \u2018injured\u2019 MDs and I are meeting with peter marks and paul Richards [sic] at the FDA Monday morning. I have discussed this with Janet Woodcock and Paul for the last few weeks.<\/p>\n\n\n\n

\u201cHopeful they will be willing to help us \u2018nobodies\u2019 in our quest to get medical help for people, or any sort of acknowledgement so people are able to begin dialogue with their home physicians.\u201d<\/p>\n\n\n\n

Some victims said Marks blew off scheduled meetings with them.<\/p>\n\n\n\n

Dr. Danice Hertz<\/a>, a retired gastroenterologist from California injured by the Pfizer-BioNTech COVID-19 shot she received in December 2020, previously told The Defender<\/a> that she and a group of vaccine-injured individuals secured a Zoom meeting with Marks in early 2021 \u2014 which he then skipped.<\/p>\n\n\n\n

Previously released documents from CHD\u2019s lawsuit against the NIH contained emails showing that Marks and Woodcock were aware of reports<\/a> about COVID-19 vaccine injuries in early 2021, including emails from injured people throughout 2021 and 2022 seeking help regarding their injuries.<\/p>\n\n\n\n

Previously released documents also revealed that Dr. Anthony Fauci<\/a> received such emails during the same period<\/a>.<\/p>\n\n\n\n

Other documents indicate that, as early as January 2022, NIH researchers were aware of at least 850 peer-reviewed case reports<\/a> and\/or research articles about COVID-19 vaccine reactions.<\/p>\n\n\n\n

In one email (name and agency redacted), NIH researchers were told the federal government was \u201csaddled\u201d with the \u201cmess\u201d of dealing with those injured by the COVID-19 vaccines, due to the liability shield<\/a> enjoyed by vaccine manufacturers<\/a>.<\/p>\n\n\n\n

Marks, FDA still publicly claim COVID shots are safe and effective<\/strong><\/p>\n\n\n\n

Marks continues to promote the COVID-19 vaccines as safe and effective<\/a> and downplay the extent and severity of vaccine-related adverse events.<\/p>\n\n\n\n

Last month, he advised the public to get newly updated formulations<\/a> of the COVID-19 shots, stating the new vaccines \u201cmeet the agency<\/a>\u2019s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.\u201d He said vaccination \u201ccontinues to be the cornerstone of COVID-19 prevention.\u201d<\/p>\n\n\n\n

In a subsequent interview with NPR<\/a> though, Marks hedged on the question of how effective the new vaccines are.<\/p>\n\n\n\n

\u201cThe vaccine is not intended to be perfect,\u201d Marks said. \u201cIt\u2019s not going to absolutely prevent COVID-19. \u2026 But if we can prevent people from getting serious cases that end them up in emergency rooms, hospitals or worse \u2014 dead \u2014 that\u2019s what we\u2019re trying to do with these vaccines.\u201d<\/p>\n\n\n\n

During congressional testimony<\/a> in February, Marks said, \u201cThere was a signal for myocarditis or pericarditis only after the primary vaccination series with the Pfizer mRNA vaccine in those 12 to 17 years of age, and that now that signal is not being seen more recently.\u201d<\/p>\n\n\n\n

Marks also claimed that numerous false reports are submitted to the Vaccine Adverse Event Reporting System (VAERS<\/a>), though other experts have disputed<\/a> this assertion.<\/p>\n\n\n\n

However, Marks also acknowledged that the FDA was overwhelmed with adverse event reports after the COVID-19 vaccines became available, stating that \u201cthe avalanche of reports was tremendous<\/a>.\u201d<\/p>\n\n\n\n


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Analysis by A Midwestern Doctor<\/a><\/p>\n\n\n\n

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