Dr. Fauci Announces Retirement In Hopes Of Avoiding Accountability For His Lies
Americans know Fauci as a fraud who has done irreparable harm to our people and our nation. Will he be held accountable?Americans know Fauci as a fraud who has done irreparable harm to our people and our nation. Will he be held accountable?FDA and Florida clash over federal restriction of monoclonal antibody treatments
On Monday, the Food and Drug Administration removed two monoclonal antibody therapies from the list of approved COVID-19 treatments, subsequently forcing treatment sites to close despite these locations being pivotol to Florida's COVID-19 response.
The FDA made this announcement Monday in a press release stating that the bamlanivimab-etesevimab cocktail and the REGEN-COV treatments were to be removed from the list of emergency use authorizations.
It continued by saying that these treatments should only be used “when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments” because “data show these treatments are highly unlikely to be active against the omicron variant.” The FDA did not elaborate or provide the data.
The FDA argued against the preventive treatments, stating that “treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
The Washington Post reported that Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research and author of Monday’s press release, said that these monoclonal antibody treatments are “highly unlikely to be active against the omicron variant” and that “these treatments are not authorized to be used at this time.”
The FDA press release states that “these [monoclonal antibody] treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”
However, the press release did not mention that the Omicron variant can circumvent COVID immunity gained through vaccination.
In an interview with the French outlet Le Monde, Ugur Sahin, the CEO of BioNTech, the co-developer of the Pfizer vaccine, confirmed this by saying, “We must be aware that even triple-vaccinated are likely to transmit the disease. ... It is obvious we are far from 95% effectiveness that we obtained against the initial virus.”
The FDA’s decision will force monoclonal antibody treatment facilities around the country to close their doors to those seeking treatment for COVID-19 other than the mRNA vaccine.
In Florida, monoclonal antibodies proved to be a vital lifeline in the state’s approach to combatting COVID-19. Officials from the state of Florida condemned the FDA’s decision, claiming it was made without any warning and determined through analyzing clinical data not made available to the public.
After @HHSGov avoided communication with @HealthyFla regarding statewide allocations, without any warning, @US_FDA suspended the use of multiple MABs treatments. Such decisions should be made based on clinical data - which the FDA has not provided.pic.twitter.com/zpWl7ZGODQ— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1643065270
The Florida Department of Health issued a statement countering the FDA. In it, the state’s Department of Health lamented being forced to shut down state-run monoclonal antibody treatment sites, stating, “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical data.”
As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below.pic.twitter.com/RGeWTPwxCs— Florida Dept. of Health (@Florida Dept. of Health) 1643080563
Watch: Dana White spars with reporter over COVID treatments, defends Joe Rogan
The fights at the UFC Vegas 46 event had ended, but there were more clashes in the post-fight press conference on Saturday night. Dana White verbally sparred with a reporter who questioned the COVID-19 treatments that the UFC president took after contracting the respiratory disease.
During the post-fight press conference, White was questioned about his friend and UFC employee Joe Rogan. A reporter asked White about the group of 270 scientists, medical professionals, professors, and science communicators who signed an open letter demanding that Spotify adopt a policy on COVID-19 misinformation because they insisted that Rogan has a "concerning history of broadcasting misinformation, particularly regarding the COVID-19 pandemic."
White was not familiar with the open letter attempting to have Spotify censor Rogan over podcasts about COVID-19. White transitioned to COVID-19 treatments by saying, "Ever since I came out and said what I did, it's almost impossible now to get monoclonal antibodies."
The fully vaccinated White contracted COVID-19 during the Thanksgiving holiday, but was "feeling like a million bucks" in less than 24 hours after receiving COVID-19 treatments recommended by Rogan.
“I get up, 9 o’clock Monday morning, and I get tested. He said get monoclonal antibodies in you as soon as possible, so I did," White told sports podcast host Jim Rome on Dec. 1. "By noon, I had the monoclonal antibodies in me. Then he told me to do a NAD drip. I did that right after."
White added that he had a dose of ivermectin and a vitamin drip.
During Saturday's press conference, White alleged, "They're making it so you can't get them. Medicine that absolutely works — they're keeping from us."
The UFC president claimed, "I don't want to get too political and start getting into all this sh**, but ivermectin and monoclonal antibodies have been around for a long time. Now all of a sudden you can't dig them up to save your life; the doctors won't give them to you."
White said that he "made one phone call" and was able to get monoclonal antibody treatment.
"And that's not some f***ing rich famous guy sh**," White added. "Like anybody could've called...Everybody could've got it back then."
He then claimed, "You can't get those things to save your life now, literally."
In late December, the federal government halted the distribution of two of the three monoclonal antibody treatments, claiming they were ineffective against the Omicron variant. According to the FDA, only the monoclonal antibody treatment called "sotrovimab" by GlaxoSmithKline and Vir Biotechnology is effective against Omicron. However, it is in short supply.
White called the lack of COVID-19 therapeutics "disgusting" and "one of the craziest things that I've ever witnessed in my life."
"And we're not talking about experimental drugs or things," White continued. "This stuff's been around. Ivermectin, the guy won a Nobel Peace Prize."
Then Yahoo reporter Kevin Iole interjected, "Are you a doctor?"
White replied, "No, but I took them, and they both worked for me, so why shouldn't I be able to take them again? Or other people?"
White roared back, "You want to know what's scary? I bet I can get some f***ing pain pills quicker than I can get monoclonal antibodies. Not maybe; that's a fact. They f***ing hand out pain pills like they're Tic Tacs. Pain pills kill you. Fact. And I’m not a doctor, but that’s a fact."
Content Warning: Strong language:
UFC President Dana White is asked about 200+ Doctors demanding Spotify censor Joe Rogan.pic.twitter.com/hNrJ6UVHmK— The Post Millennial (@The Post Millennial) 1642356215
Horowitz: Why is West Virginia’s governor touting the shot that failed him and not the monoclonal antibodies?
It has become a new ritual, in which every politician or celebrity who gets COVID proceeds to tout the vaccine’s success in preventing a worse outcome – without any evidence that the vaccine played a role. Now we have politicians getting COVID bad, and they still credit the vaccines that failed rather than the treatments that succeed. Then they tell their constituents to double down on failure without sharing the secret of their success. Why is there a double standard between their own treatment and that of the rest of the public?
On Tuesday, West Virginia Gov. Jim Justice tested positive for COVID after his office described him as “extremely unwell” and suffering “moderate” COVID symptoms. Moderate COVID is more serious than mild COVID. This is not what we would expect from a vaccine with a modicum of efficacy after Justice bragged about getting three shots (and is now asking for fourth doses). Justice then relied upon the monoclonal antibodies for treatment, and his office put out an update on Thursday saying he feels “100% better” after “the antibodies really kicked in.”
One would expect the next sentence of the governor’s statement to be something along the following lines: “We now see that even with three shots, one can get very sick from this virus, so clearly we cannot rely on the vaccines to work. On the other hand, the monoclonal antibodies seem to be a lifesaver. As such, we will now place all our funding, emphasis, and public health notices into the promotion of the monoclonals and not the shots. After all, those with the shots need the monoclonals, but those with the monoclonals clearly don’t need the shots.”
Instead, Justice’s chief of staff, Brian Abraham, had the following message for the public: “The thing that he really wants to stress is that if he hadn’t had the vaccinations he thinks this would have been a far different outcome.”
The vaccine can never lose! If someone gets the virus mildly, it’s automatically because of the vaccine, but if they get it worse, well … it still would have been worse without it, never mind the monoclonal antibodies.
This is similar to what happened with Maryland Governor Larry Hogan next door. He got COVID after having received three vaccines, then relied on the monoclonal antibodies for personal treatment. Two days later, the Maryland Department of Health suspended the monoclonals, claiming they don’t work, and proceeded to shame people into getting more boosters. But if the monoclonals don’t work with real live antibodies, then most certainly the shots no longer work! Yet the vaccines are so effective that they work even when they don’t work.
This is becoming like a full-fledged idolatry, or perhaps a two-tiered health system in which they promote what doesn’t work for the plebes while availing themselves of the monoclonal antibodies. Although the politicians never disclose what other treatment they received, it’s safe to say they don’t face the same obstacles with doctors and pharmacies as the general public.
What is so sad is that even before the virus dramatically changed, there was never any real evidence that the shots stimulated robust immunity for those who needed it the most. Only 4% of the Pfizer trial participants were over the age of 75, even though they compose more than 50% of COVID deaths. Likewise, just 21% of the Pfizer participants had at least one comorbidity. Whereas a recent NIH/CDC study on “breakthrough” COVID deaths shows that 77.8% of those who died after having been vaccinated had at least four comorbidities. Shouldn’t the most important thing for those people be the promotion of the monoclonals and other treatments, not placing more spike protein in their bodies, which clearly doesn’t even stimulate much of an immune response?
A study published last year in the Journal of Infectious Diseases found that vaccination stimulated a “significantly lower proportion” of spike-specific T cells in organ transplant patients than natural infection. Yet, rather than exhibiting compassion and focusing on treatment for the severely immunocompromised, officials are denying people transplants if they fail to now get a third shot of what failed to protect them the first time.
Biden's FDA prioritizes race in administering life-saving COVID therapeutics; 'Latinx ethnicity' a higher priority in Utah than those with congestive heart failure
For Americans suffering from COVID-19 and seeking life-saving treatment, they may find themselves put on a waitlist depending on their skin color. The Food and Drug Administration, as well as multiple states, will prioritize race and ethnicity in determining who receives hard-to-get COVID-19 therapeutics. In some cases, even those with dangerous health conditions could be passed over for someone who is "non-white."
GlaxoSmithKline's sotrovimab is reportedly the only monoclonal antibody treatment that is effective against the Omicron variant — however, it is in very short supply.
The FDA's "fact sheet" for sotrovimab presents health care providers with a guidance on the emergency use authorization of the treatment. There is a "patient selection" section that outlines who should receive the sotrovimab treatment, especially since it is in limited availability at this time. The fact sheet lists "medical conditions or other factors may place adults and pediatric patients at higher risk for progression to severe COVID-19." Some of the conditions on the list include being aged 65 or older, obesity, chronic kidney disease, diabetes, and cardiovascular disease.
The guidance also adds a stipulation:
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above.
The Centers for Disease Control and Prevention states that high-risk individuals include people over age 65 and those with underlying medical conditions.
The CDC also proclaims:
Long-standing systemic health and social inequities have put various groups of people at increased risk of getting sick and dying from COVID-19, including many people from certain racial and ethnic minority groups and people with disabilities.
Studies have shown people from racial and ethnic minority groups are also dying from COVID-19 at younger ages. People in minority groups are often younger when they develop chronic medical conditions and may be more likely to have more than one condition.
Some states have adopted the guidances from the FDA and CDC that prioritizes race or ethnicity when determining who receives the therapeutic.
Last month, Minnesota released the state's "Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic" guidance.
The FDA has acknowledged that in addition to certain underlying health conditions, race and ethnicity "may also place individual patients at high risk for progression to severe COVID-19.' FDA’s acknowledgment means that race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for mAbs. It is ethically appropriate to consider race and ethnicity in mAb eligibility decisions when data show elevated risk of poor COVID-19 outcomes for Black, Indigenous and other people of color (BIPOC populations), and that this risk cannot be adequately addressed by determining eligibility based on underlying health conditions (perhaps due to underdiagnosis of health conditions that elevate risk of poor COVID-19 outcomes in these populations).
The guidance adds, "At the present time, MDH has found that available data show this elevated risk."
In Utah, the state released its "Crisis Standards of Care Monoclonal Antibody Allocation Guidelines."
The guideline provides a risk score based on risk factors such as age and obesity and assigns a point value to each factor. Shockingly, being "Non-White race or Hispanic/Latinx ethnicity" holds a higher risk value than high-risk co-morbidities such as hypertension, coronary artery disease, cardiac arrhythmia, congestive heart failure, chronic kidney disease, chronic pulmonary disease, chronic liver disease, cerebrovascular disease, chronic neurologic disease, and those suffering from shortness of breath.
Earlier this month, TheBlaze reported on the New York state government's decision to prioritize non-white people to receive COVID-19 treatments because of "longstanding systemic health and social inequities."
When it comes to the distribution of monoclonal antibodies as well as the new oral antiviral pills — Pfizer's Paxlovid and Merck's molnupiravir — New York's Department of Health declares, "Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19."
Florida surgeon general says Biden admin is 'actively preventing' distribution of monoclonal antibody treatment amid Omicron surge
The Biden administration is "actively preventing the effective distribution of monoclonal antibody treatments" for treatment of COVID-19, according to Florida Surgeon General Dr. Joseph Ladapo.
In a letter addressed to Health and Human Services Secretary Xavier Becerra, Ladapo said the federal government's abrupt pause of monoclonal antibody treatment distribution is causing "another immediate and life-threatening shortage of treatment options to the State of Florida."
"The sudden suspension of multiple monoclonal antibody therapy treatments from distribution to Florida removes a health care provider's ability to decide the best treatment options for their patients in this state," Ladapo wrote.
"This shortsightedness is especially evident given that the federal government effectively prohibited states from purchasing these monoclonal antibodies and serving their populations directly," he continued. "Florida is a large, diverse state with one of the highest percentages of seniors in the U.S., and we must empower health care providers to make decisions that will save the lives of Americans everywhere without the dictates imposed by the federal government."
Ladapo concluded his letter by using President Joe Biden's own words against him, writing:
President Biden recently stated there is no federal solution to COVID-19, and solving this pandemic will happen at the state level. Therefore, as Surgeon General, I respectfully request that you allow states and healthcare practitioners to provide treatment options that best benefit the communities they know and serve.
Indeed, while speaking to governors on Monday, Biden said, "Look, there is no federal solution. This gets solved at a state level."
NEW: Florida Surgeon General says Biden Admin is "actively preventing" distribution of monoclonal antibodies by pausing shipments of Regeneron, in letter to HHS Sec. \n \nFeds paused Regeneron bc it may not work against Omicron. FL says it can still be used in existing Delta cases.pic.twitter.com/9mmw5SsuZJ— Jay O'Brien (@Jay O'Brien) 1640731733
Last week, the Biden administration ceased the distribution of COVID-19 antibody treatments from Eli Lilly and Regeneron Pharmaceuticals.
In a joint statement, the Food and Drug Administration and the Office of Assistant Secretary for Preparedness and Response explained the decision was needed because the Omicron variant "may be associated with resistance to monoclonal antibodies."
Some states, in fact, are already running out of their monoclonal antibody supply.
Texas announced Tuesday that its infusion centers have exhausted the state's supply. The statement noted "the federal government controls the distribution of monoclonal antibodies." Texas public health officials said that new oral antiviral drugs authorized by the FDA may be an alternative treatment, but noted the initial distribution of such drugs will be limited and that "the federal government will also control their distribution."
Although monoclonal antibodies have been denounced in lieu of vaccines, Forbes noted that monoclonal antibodies "have proven to be a valuable asset in the war against COVID-19."
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