Tag: fda

Babies put at risk, even killed, in ‘reputable’ studies over the years

Public health officials and other medical professionals have helped untold millions over the years. But the hard truth is that some have hurt many.

This was a difficult lesson I learned many times when I was assigned to investigate FDA, CDC, NIH and pharmaceutical industry scandals at CBS News.

One of the most heartbreaking early stories I investigated in 2000 was the death of a baby who was given an experimental heartburn drug called Propulsid as part of a study. His death had been ruled a mysterious SIDS (Sudden Infant Death Syndrome) death.

Little Gage Stevens’ parents didn’t know that the drug he took, Propulsid, had been linked to dozens of deaths, including at least one other baby, before Gage even got his first dose. Shortly after Gage died, Propulsid was pulled from the market — linked to more than 300 deaths.

Read the death certificate on Gage.

My investigation revealed that the study consent form falsely stated Propulsid, made by Johnson and Johnson, was “approved by the FDA” for children. In fact, the Food and Drug Administration had repeatedly rejected it for pediatric use.

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FDA Says Ivermectin Doesn’t Work Against COVID-19 But Points To Studies That Show It Does

The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does not work against COVID-19 but links to studies that show it does, an Epoch Times review has found.

The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.”

But half of the studies to which the FDA points support using ivermectin against COVID-19, according to the review.

The papers cut against the drug agency’s repeated exhortations for people not to take ivermectin for COVID-19. In Twitter posts, public statements, and emails, FDA officials have repeatedly warned against ivermectin. Some of those statements triggered a lawsuit from doctors who say the agency’s role is to approve drugs, not to issue recommendations. The suit was dismissed this week.

Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and co-authored a meta-analysis that concluded the drug is effective against the illness, told The Epoch Times that the government’s position on ivermectin “is one of the most glaring examples of the corruption of modern evidence based medicine.”

“There’s one message they want everyone to understand. And that message is that ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s theirs. That’s their perverted and distorted interpretation of the data.”

The FDA’s media office did not respond to a request for comment.

Dr. Janet Woodcock, a top official at the agency who was its commissioner from January 2021 to February 2022, told The Epoch Times via email that “ivermectin has been shown to be ineffective against COVID in large randomized trials.”

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FDA approves unpopular bivalent Covid shot for BABIES and ‘encourages parents to get their child vaccinated before the holidays’

US health officials today approved Pfizer and Moderna‘s bivalent Covid vaccines for babies, in a move bound to draw criticism.

The Food and Drug Administration (FDA) has green-lit plans for the updated shots to be given as part of a three-dose course for children aged six months to four years.

Agency officials said they ‘encourage parents and caregivers’ to get their child vaccinated ‘especially as we head into the holidays and winter months’.

It comes after a study found the bivalent vaccines are significantly weaker against a rising Covid variant expected to become dominant in the US in months.

Pre-school-aged children were already allowed to receive three extra-small doses of Pfizer’s original Covid vaccine, instead of the standard two-dose regimen for adults.

The move will see them given the Omicron-specific booster – made by either Pfizer of Moderna – as their third and final shot.

Officials recommend the children to receive the bivalent shot from the same brand they received their first two vaccine shots from.

So a child who receive the Pfizer vaccine for their first two doses should get the Pfizer bivalent shot as well. 

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FDA social media posts on COVID under legal, medical scrutiny for misleading claims

The FDA’s Twitter habits are getting scrutiny in court and from medical professionals as the feds seesaw between walking back their once-confident COVID-19 assertions and making sweeping new claims without providing evidence.

Having long ago conceded that COVID vaccines can’t stop viral transmission and that assertions to the contrary by President Biden among others were based on “hope” rather than science, the feds are now downplaying the influence of their social media to escape liability for allegedly violating statutory limits by interfering in medical judgments.

At the same time, over the past two months, FDA Commissioner Robert Califf has gone on a spree of evidence-free tweets about bivalent boosters and oral antivirals, such as Pfizer’s rebound infection-prone Paxlovid, prompting exasperation from leading doctors.

The FDA’s “social media statements … are what bother me the most,” U.S. District Judge Jeffrey Brown said in a hearing this month on the government’s motion to dismiss a lawsuit by three doctors who claim the agency’s false portrayals of ivermectin have harmed their ability to treat patients and threatened their licenses.

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FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation

The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment.

The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

In a separate page, the FDA said: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.

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FDA Announces LAB GROWN MEAT That Was Served at COP27 Climate Conference Is ‘SAFE TO EAT’: ‘The World Is Experiencing A Food Revolution’

The US Food and Drug Administration has approved lab-grown meat, a product grown from animal cells, for human consumption for the first time.

The FDA announced Wednesday that laboratory-grown chicken developed by Upside Food, is “safe to eat,” clearing the way for the California-based company that creates cell-cultured chickens to begin selling its products.

To manufacture its meat, Upside Foods harvests cells from live animals, chicken tissue, and uses the cells to grow meat in stainless-steel tanks known as bioreactors.

The agency issued a statement Wednesday announcing it evaluated Upside Food’s production and cultured cell material and has “no further questions” about the safety of its cultivated chicken filet.

“The world is experiencing a food revolution,” stated FDA Commissioner Robert M. Califf. “Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock poultry, and seafood in the production of food with these products expected to be ready for the US market in the near future.”

“The FDA’s goal is to support innovation in food technologies while always maintaining as our first priority the safety of the foods available to US consumers,” he added.

Upside Foods founder and CEO Uma Valeti heralded the FDA’s approval.

“I’ve been looking forward to this day for a long time. UPSIDE has received our “No Question Letter” from the FDA. They’ve accepted our conclusion that cultivated chicken is safe to eat, meaning UPSIDE is one step closer to being on tables,” Valeti tweeted.

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FDA Withholds Autopsy Results of Those Who Died After COVID Shots

The U.S. Food and Drug Administration (FDA) has refused a Freedom of Information Act (FOIA) request to release the autopsy results of people whose deaths were reported to the Vaccine Adverse Event Reporting System (VAERS) after receiving a COVID-19 shot. The FOIA request was submitted by The Epoch Times newspaper.1

“VAERS is a centralized vaccine reaction reporting system that was among the safety provisions secured by parents of DPT (diphtheria-pertussis-tetanus) vaccine injured children in the National Childhood Vaccine Injury Act (NCVIA) of 1986,” explains Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC). It is jointly operated by the FDA and U.S. Centers for Disease Control and Prevention (CDC).2 3

According to The Epoch Times, the FDA declined to release any autopsy reports of VAERS deaths, even redacted copies, citing FOIA section (8) (A) which allows federal agencies to withhold information from the public if an agency “reasonably foresees that disclosure would harm an interest protected by an exemption,” with the exemption being “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

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Smoking gun? FDA refusing to provide key covid “vaccine” safety analyses, suggesting massive coverup

Government regulators at the U.S. Food and Drug Administration (FDA) say they will not release any of the agency’s Covid-19 “vaccine” safety analyses for independent review because their findings are allegedly part of internal discussions that are protected by law.

Back in July, The Epoch Times submitted a request to the FDA for all analyses performed using a special method called Empirical Bayesian data mining. This method involves comparing adverse events recorded after injection with a Fauci Flu shot to adverse events recorded after injection with some other non-covid vaccine.

Whatever data these analyses produced was used by the FDA to foist Chinese Virus shots on everyone, including infants and toddlers. (Related: Check out our earlier coverage about the FDA’s suspicious secrecy to learn more.)

The operational procedures laid out by the agency and its partner in January 2021 and February 2022 stipulate that the FDA is to perform data mining “at least biweekly,” if not more often than that, to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” That data was to come from the official Vaccine Adverse Event Reporting System (VAERS).

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FDA to Authorize New COVID Booster for Omicron – But No Human Trials, Only Mice

The ‘Emergency Use Authorization’ canard seems to be the key tool which Big Pharma and Big Government use to run their confidence trick on a largely unsuspecting public. More fast-tracked ‘testing’ means more mass experimentation on the general population.

When it comes to the vaccine business, the hundreds of millions spent by industry lobbyists continues to pay massive dividends. Despite the fact that there is no discernible COVID-19 ‘pandemic’ anywhere, operatives embedded in corrupt institutions like the FDA are continuing to push the false premise that the world in stuck in a perpetual state of emergency, thereby justifying any and every half-baked measure and legal loophole – all designed to push products which are either being subsidized or directly purchased by government. That’s why business is still booming.

So let the ‘game of variants’ begin again.

It’s the same oil script being trotted out by the usual suspects…

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FDA Can’t Stop Harassing Distillers Who Made Hand Sanitizer During the Pandemic

One year ago, when distiller Aaron Bergh of Calwise Spirits in Paso Robles, California, donated the last of the hand sanitizer he had produced to address shortages during the early days of the COVID pandemic, he assumed that this unexpected detour in the life of his small business was behind him. Then, in June, he received an unexpected letter from the Food and Drug Administration (FDA) informing him that a sample of his sanitizer taken in December 2020 exceeded temporary limits of two impurities and demanding extensive records of his production and distribution.

Bergh isn’t the only one. Rebecca Harris, president of the American Craft Spirits Association, says that at least 11 distillers in nine states have received similar letters from the FDA. At primary issue is acetaldehyde, a chemical that occurs naturally in fruits and dairy products, as well as in beer, wine, and spirits. The FDA sets limits on its presence in hand sanitizer at 50 parts per million (ppm). The sample from Bergh’s distillery tested at 160 ppm and 167 ppm of acetaldehyde and acetal, respectively.

There are valid reasons to limit levels of acetaldehyde in hand sanitizer. The chemical is a potential irritant and is considered a known carcinogen. Yet, it’s also one that most of us consume on a regular basis due to its natural occurrence in many foods and drinks; it’s also produced in our bodies whenever we have an alcoholic beverage as part of the process of breaking down ethanol. If you’ve enjoyed a banana or a beer recently, you’ve consumed acetaldehyde. As with any potentially toxic substance, the risks vary with the level and route of exposure.

The new round of letters from the FDA raises two questions. The first is whether the levels of acetaldehyde in sanitizer produced by distillers rises to levels where they pose a real risk to users. The second is, if there is a genuine risk, why has the agency waited more than 18 months after taking samples to begin acting on the test results, long after the sanitizer was distributed to health care workers and consumers?

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