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Ex-FDA Adviser: Agency Ignoring Requirement to Disclose COVID-Shot Risks

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A former adviser to the FDA commissioner who continues to serve in an oversight role says the agency is ignoring its requirement to disclose clear safety and efficacy problems with the COVID-19 vaccines.

David Gortler wrote in a column Friday for the Federalist that, for example, the FDA, Centers for Disease Control, Pfizer and Moderna have known from the beginning about myocarditis and pericarditis risks from the mRNA vaccines.

And there are many other adverse events reported in the tracking system run by the FDA and the CDC, the Vaccine Adverse Event Reporting System, or VAERS.

Yet no formal warnings have been made to Americans, such as labeling and letters to warn physicians, pharmacists, or the American public.

“Why? One reasonable explanation is because it would counter the narrative that endless vaccines and boosters is your patriotic duty,” Gortler wrote. (Read more from “Ex-FDA Adviser: Agency Ignoring Requirement to Disclose COVID-Shot Risks” HERE)

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Hidden Camera: FDA Exec Says Biden Will Require Annual COVID Shots

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A U.S. Food and Drug Administration executive disclosed in a conversation captured on hidden camera by a Project Veritas journalist that President Biden plans to require Americans to get an annual COVID-19 shot, which will be a “fountain of revenue” for the drug companies.

Christopher Cole said Biden “wants to inoculate as many people as possible.”

“You’ll have to get an annual shot,” he said. “I mean, it hasn’t been formally announced yet ‘cause they don’t want to, like, rile everyone up.”

Cole, captured on camera at a restaurant, acknowledged the financial “incentive for Pfizer and the drug companies to promote additional vaccinations.”

“It’ll be recurring fountain of revenue. It might not be that much initially, but it’ll be recurring — if they can — if they can get every person required at an annual vaccine, that is a recurring return of money going into their company,” he said. (Read more from “Hidden Camera: FDA Exec Says Biden Will Require Annual COVID Shots” HERE)

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State Moves to Make Ivermectin Available to Consumers

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The U.S. Food and Drug Administration has posted pages of detailed information online about “Why you should not use ivermectin to treat or prevent COVID-19.” . . .

That’s even though Dr. Theresa Lawrie, a U.K. medical doctor and research analyst who founded the British Ivermectin Recommendation Development initiative (BiRD International) suggested it has significant benefits against contracting, or dying from, COVID-19.

Now, a report confirms officials in one state are trying to make it easier for consumers to obtain, even though the FDA stands by its dire warnings.

The report said lawmakers in New Hampshire are working on legislation that would give consumers access to the treatment through ordinary procedures at a pharmacy.

House Bill 1022 would allow pharmacists to dispense the drug by means of standing orders, the report said. (Read more from “State Moves to Make Ivermectin Available to Consumers” HERE)

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Fauci Pushing to Get COVID Vaccines Approved for Children Under 5

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Despite the federal government data and the acknowledgment of health officials that healthy children are statistically at zero risk of serious illness or death from COVID-19, that the vaccines don’t prevent infection or transmission of the virus, and that the current omicron variant presents with mild symptoms, White House coronavirus adviser Dr. Anthony Fauci said he hopes the Food and Drug Administration will approve Pfizer and BioNTech’s vaccine for children under 5 years old in the next month.

Further, Fauci said three vaccine doses likely will be needed, because Pfizer found in its clinical trials in children ages 2 to 4 that two shots did not induce an adequate immune response.

In stark contrast, the World Health Organization’s chief scientist said this week that healthy children and adolescents don’t need COVID-19 vaccine booster doses.

“There is no evidence right now that healthy children or healthy adolescents need boosters. No evidence at all,” said Soumya Swaminathan at a news briefing Tuesday. . .

Fauci said in an interview Wednesday with Blue Star Families that he hopes the FDA will grant approval “within the next month or so and not much later than that, but I can’t guarantee that.” (Read more from “Fauci Pushing to Get COVID Vaccines Approved for Children Under 5” HERE)

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FDA Lifts In-Person Restrictions on Abortion Pill

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The Food and Drug Administration (FDA) eased restrictions Thursday on at-home drug-induced abortions by allowing women and girls to end their pregnancies via mail-order pills without having to see an abortion provider in person.

Earlier this year, the FDA had already eased restrictions on the requirement of in-person assessment for drug-induced abortion due to the coronavirus pandemic. The abortion industry and its allies quickly readied tele-abortion services to be utilized on a permanent basis.

In April 2020, Planned Parenthood CEO Alexis McGill Johnson referred to telemedicine abortion as the “silver lining” of the coronavirus pandemic.

Johnson told Democracy Now’s Amy Goodman the fact that many states had attempted to include elective abortions among other procedures that should be temporarily banned to preserve scarce medical equipment for healthcare workers treating coronavirus patients was “unconscionable.” (Read more from “FDA Lifts In-Person Restrictions on Abortion Pill” HERE)

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OUTRAGEOUS: FDA Forces a Popular Baby Monitor off the Market — But Not Because It’s Unsafe

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In yet another instance of the federal government’s war on parents, the Food and Drug Administration is cracking down on a popular baby monitoring device called the Owlet Smart Sock. While the agency’s concerns have nothing to do with the product’s safety, Owlet Baby Care has been forced to pull its device off the market.

The Owlet Smart Sock is a high-tech baby monitoring device that allows parents to track their baby’s sleep patterns, heart rate, and oxygen levels. Through a washable “sock” that easily wraps around the baby’s foot and connects to a wireless base, it alerts parents should their baby’s heart rate or oxygen levels get too high or too low. Parents can also monitor oxygen levels and sleep trends through Owlet’s free iOS and Android app.

That is, parents could do these things, prior to the FDA using its regulatory powers to ban parents from being able to purchase the high-tech baby monitoring device. In a warning letter dated Oct. 5, the FDA alleged Owlet was marketing its Smart Sock in violation of the Federal Food, Drug, and Cosmetic Act.

The agency claims the sock is a medical device that requires premarket approval to sell in the United States because it is “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” Until Owlet obtains proper approval, the FDA ordered the company to stop selling the product or face “seizure, injunction, and civil money penalties.” (Read more from “The FDA Forces a Popular Baby Monitor off the Market — But Not Because It’s Unsafe” HERE)

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Scientists Say Groundbreaking New Gel Treatment Reverses Paralysis in Mice as Researchers Prepare to Request FDA Approval for Human Trials (VIDEO)

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Researchers say that a brand-new treatment has cured mice of paralysis after just four weeks of treatment, according to a release from Northwestern Now.

Citing scientific findings — which were published in journal Science on Thursday — researchers at Northwestern University stated that new injectable gel therapy is allowing previously paralyzed mice to walk again.

Scientists say that the groundbreaking gel, which is said to use synthetic nanofibers in order to mimic the natural environment around the spinal cord, is able to communicate with organic cells to promote regeneration.

A press release from Northwestern Now states, “Researchers found that intensifying the motion of molecules within the nanofibers led to greatly improved repair after injury.”

“Cell receptors are in constant motion, so rapidly moving ‘dancing molecules’ can more effectively hit these moving targets,” the release continued. “In an animal study, the therapy successfully regenerated axons of the cord’s neurons, reduced scar tissue, promoted myelin growth, triggered blood vessel formation, and helped motor neurons survive.”

(Read more from “Scientists Say Groundbreaking New Gel Treatment Reverses Paralysis in Mice as Researchers Prepare to Request FDA Approval for Human Trials” HERE)

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Former FDA Commissioner: Pfizer Pill Means Pandemic’s End ‘in Sight’ (VIDEO)

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Appearing Friday on CNBC’s Squawk Box, former FDA commissioner Dr. Scott Gottlieb stated that the end of the coronavirus pandemic in the U.S. is “in sight” after Pfizer announced that its experimental antiviral pill slashed risk of hospitalization or death from the illness by 90 percent in a trial.

(Read more from “Former FDA Commissioner: Pfizer Pill Means Pandemic’s End ‘in Sight’ (VIDEO)” HERE)

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FDA Panel Recommends Children Receive COVID Vaccine

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A key Food and Drug Administration advisory committee on Tuesday recommended a lower dose of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5 to 11, a critical step in getting some 28 million more kids in the U.S. protected against the virus as the delta variant spreads.

The endorsement by the agency’s Vaccines and Related Biological Products Advisory Committee will now be considered by the FDA, which could issue a final decision within days. The vote was nearly unanimous, with 17 members backing it and one abstention.

The agency doesn’t always follow the advice of its independent committee, but it often does. Next week, a Centers for Disease Control and Prevention vaccine advisory group is expected to make its own recommendation. If it issues an endorsement and CDC Director Dr. Rochelle Walensky signs off, shots for young kids could begin immediately.

The Biden administration said it plans to distribute the doses as soon as it’s authorized by the FDA and CDC, which is expected to come early next month. The administration said it’s procured enough vaccine to inoculate all 28 million 5- to 11-year-olds in the U.S., and will distribute it in smaller dosing and with smaller needles to make it easier for pediatricians and pharmacists to administer to kids. (Read more from “FDA Panel Recommends Children Receive COVID Vaccine” HERE)

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Leaked Contracts: Pfizer Shifted Risk to Government, Maximized Profits

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Pfizer, the first vaccine maker to receive FDA approval for a COVID shot, has used its power to “shift risk and maximize profits,” according to a consumer advocacy group that obtained secret government contracts.

Public Citizen found that only five of the 73 deals Pfizer has made worldwide for its COVID-19 vaccine have been formally published by governments, and they have “significant redactions,” DailyMail.com reported.

“The contracts offer a rare glimpse into the power one pharmaceutical corporation has gained to silence governments, throttle supply, shift risk and maximize profits in the worst public health crisis in a century,” Public Citizen alleges in its report.

The Manhattan-based pharmaceutical company “consistently place Pfizer’s interests before public health imperatives.”

Public Citizen accuses Pfizer of including secret language blocking donations of its own doses, opposing an intellectual property waiver that could have allowed for the sharing of technology, having ‘unilateral authority for other decisions’ and more. (Read more from “Leaked Contracts: Pfizer Shifted Risk to Government, Maximized Profits” HERE)

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