Tag: fda

Not Even the FDA Trusts the FDA To Regulate Food Safety

Last week, the Food and Drug Administration (FDA) announced the agency has sought an external review of its approach to food safety. The surprising announcement, issued by FDA commissioner Dr. Robert Califf, says the review will look primarily at work carried out by the FDA’s Office of Food Response and Policy (OFPR) and Center for Food Safety and Applied Nutrition (CFSAN).

In his announcement, Califf stresses that America’s food supply is safe. But he also notes issues with the agency’s food-safety inspection regime and says “the increasing diversity and complexity of the nation’s food systems and supply chain” have raised fundamental “questions about the structure, function, funding[,] and leadership” of the FDA.

As Politico, The New York Times, and others have reported, the external FDA review comes as the agency is hammered for its role in an ongoing shortage of baby formula. But suggestions that this review is all (or even largely) about baby food are likely off base. Consider that Califf’s announcement didn’t mention baby formula. What’s more, the it’s-the-baby-formula crowd suffers from recency bias. In fact, there’s no shortage of non-formula reasons why the FDA’s food-safety oversight is in critics’ crosshairs.

Last year, for example, the FDA celebrated the ten-year anniversary of the Food Safety Modernization Act (FSMA), which the agency and many of the law’s supporters have touted as the most extensive, impactful, and important overhaul of the FDA’s food-safety authority in more than 75 years. It’s not. As I noted in a column marking FSMA’s first (and hopefully last) decade, CDC estimates of the number of annual cases of foodborne illness in America have remained unchanged in the wake of FSMA’s passage and implementation.

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‘Like a Horror Movie’: Top Scientists Alarmed and Embarrassed by Agencies’ Failure to Follow Science on COVID

Top doctors and scientists at the leading U.S. public health agencies are “frustrated, exasperated and alarmed” about the direction of the agencies they work for, according to the authors of a Substack post published last week.

They’re also embarrassed — about “bad science.” And many are leaving.

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” said one senior official with the U.S. Food and Drug Administration (FDA). “People are getting bad advice and we can’t say anything.”

The comment was one of many culled from calls and text messages between officials and the article’s co-authors, Marty Makary M.D., M.P.H., and Tracy Beth Høeg M.D., Ph.D.

Makary and Høeg said the officials who spoke to them agreed to be quoted — but only anonymously, for fear of professional repercussions.

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are plagued with “low morale” and “high turnover,” officials told Makary and Høeg.

“At the NIH, doctors and scientists complain to us about low morale and lower staffing: The NIH’s Vaccine Research Center has had many of its senior scientists leave over the last year, including the director, deputy director and chief medical officer,” they wrote.

And it’s no better at the CDC, they said:

“The CDC has experienced a similar exodus. ‘There’s been a large amount of turnover. Morale is low,’ one high-level official at the CDC told us. ‘Things have become so political, so what are we there for?’ Another CDC scientist told us: ‘I used to be proud to tell people I work at the CDC. Now I’m embarrassed.’”

Officials complained the heads of their agencies “are using weak or flawed data to make critically important public health decisions, that such decisions are being driven by what’s politically palatable to people in Washington or to the Biden administration and that they have a myopic focus on one virus instead of overall health.”

One CDC scientist told Makary and Høeg about the shame and frustration within the agency over what happened to U.S. children during the pandemic.

The scientist said:

“CDC failed to balance the risks of COVID with other risks that come from closing schools. Learning loss, mental health exacerbations were obvious early on and those worsened as the guidance insisted on keeping schools virtual. CDC guidance worsened racial equity for generations to come. It failed this generation of children.”

The CDC also ignored natural immunity, according to some officials who declined to be named. “The vast majority of children have already had COVID, but this has made no difference in the blanket mandates for childhood vaccines.”

By mandating “vaccines and boosters for young healthy people, with no strong supporting data, these agencies are only further eroding public trust,” they added.

“I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement,’” one official told Makary and Høeg.

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FDA-Approved Brain Computer Interface Company “Synchron” Implants First Brain Device in US Patient

New York-based Synchron, the startup behind an FDA ‘breakthrough neuroprosthesis device,’ successfully implanted its first brain device in a patient in the US earlier this month, Bloomberg first reported.

According to the news outlet, a doctor at Mount Sinai West Medical Center in New York inserted a “1.5-inch-long implant consisting of wires and electrodes into a blood vessel in the brain of an ALS patient” on July 6.

In August 2020, Synchron becomes the first brain-computer interface (BCI) company to receive the FDA’s approval to conduct an investigational device exemption (IDE) clinical trial of a permanently implanted device.

NIH awarded Synchron $10 million to begin a US trial of a brain implant that allows users to manage digital apps using only their thoughts, as reported by Fierce Biotech.

“Our neuroprosthetics are designed to help people get their lives back by restoring lost functions,” Synchron wrote on its website.

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FDA will not require clinical trial data to authorize redesigned COVID boosters -official

The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.

Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emergency use authorization submissions before the fall.

Preclinical data from animal studies and safety data could also be available, he said.

The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 sublineages.

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Biden ‘Nanny State’ Comes For The Smokers

One day after the Biden administration said it would develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes, a new report via WSJ said the Food and Drug Administration (FDA) is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market.

WSJ cites people familiar with the matter who said the FDA decision could come as soon as today. 

“The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” WSJ notes. 

Juul has spent the last several years attempting to regain the trust of the FDA and the public. The company limited marketing and stopped selling fruity flavors in 2019 — since then, sales have tumbled. 

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Bombshell Oxford Study: Less than 6% of “Approved” Medical Drugs Are Backed by “High-Quality Evidence” to Support Their Benefits – “Harms” are Significantly Underreported Across the Board

According to a newly released study by the University of Oxford, a jaw-dropping 94% of recently approved medications are not supported by high-quality evidence that demonstrates their benefits. What’s more, just like with the experimental Covid-19 ‘vaccines,’ side effects and adverse reactions to these drugs are being severely underreported across the board.

When looking at medical drugs that have been approved since 2008 under the Cochrane reviews – a “leading” international journal and database that is endorsed by over 100 organizations worldwide, including the US Food and Drug Administration (FDA) -researchers determined that just 87 of the 1,567 medications (6%) had clinical data that met the “high-quality” standard.

From the Oxford study:

“Of 1567 eligible interventions, 87 (5.6%) had high quality evidence on first-listed primary outcomes, positive, statistically significant results and were rated by review authors as beneficial.”

Unbelievably, the majority of these drugs could not even pass the ‘moderate-quality’ review, with over 50% failing to meet the reduced threshold. And yet, consumers have access to these drugs, which are causing unknown and underreported side effects – something that should amount to medical malpractice at the very least. That is – if we lived in a sane, well-functioning society.

One of the study’s authors, Dr. Jeremy Howick, certainly thinks so. Writing about the findings, Dr. Howick deemed the issue worrisome and stressed that, with this happening, ‘informed choice’ about medical treatments is essentially impossible.

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FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine

Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19.

In the company’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, a type of heart inflammation also associated with mRNA vaccines, detected within 20 days post-vaccination. One patient in the trial reported myocarditis after receiving a placebo.

“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,” FDA staff wrote in briefing documents that were released on Friday.

They continued: “Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine. However, interpretation of these passive surveillance data is not straightforward, and further evaluation is needed to inform the risk of myocarditis and pericarditis associated with this vaccine, and their outcomes, as additional data emerge over time.”

The agency said it has asked Novavax to flag the risk of myocarditis and pericarditis, another type of inflammation of the heart, as an identified risk in its documentation. Data from Novavax’s trial was acquired before the Omicron and Delta variants spread across the world.

“Based on the efficacy estimate in the clinical trial of this vaccine,” the FDA staff wrote, “it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease.”

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FDA Says CRISPR Gene-Edited Cattle Safe for Human Consumption

The U.S. Food and Drug Administration (FDA) has determined that short-haired cattle produced through CRISPR gene-editing technology are safe for human consumption. The cattle, known as PRLR-SLICK, were the first to receive an FDA “low-risk determination for enforcement discretion” after the agency determined the intentional genomic alteration (IGA) of the two genome-edited cattle does not raise any safety concerns.

Produced by Acciligen with climate change in mind, the cows have a genetic trait that gives them a short, sleek coat which is said to help the animals cope with hot weather more effectively. The FDA’s low-risk determination means the agency does not expect Acciligen, a “precision breeding” company, to seek regulatory approval before marketing products from the cattle.

The FDA spent years reviewing the two other genetically altered animals approved for human consumption—a faster-growing salmon and a pig the agency determined was safe for consumption by people with meat allergies. However, the review process for the CRISPR beef cattle took less than a year because the FDA noted the gene-editing results in the same slick-hair trait seen in cattle that are found in conventional agriculture. Talking about the Mar. 7, 2022 approval, Steven Solomon, director of the FDA Center for Veterinary Medicine, said:

“We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs (intentional genomic alterations) to more efficiently reach the marketplace.”

Looking closer at Acceligen, the company website says that most of its workers have backgrounds in the farm industry. The company explains that “precision breeding” is different from conventional breeding or genetically modified organisms (GMO) in that it allows a “highly desired trait” that may typically take years to show up to be expressed in “just one breeding cycle.”  

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FDA Chief Claims “Misinformation” is Leading Cause of Death in the United States

During an appearance on CNN, FDA chief Dr. Robert Califf asserted that the leading cause of death in the United States is online “misinformation.”

Yes, really.

Califf spoke about his remarks during an interview with CNN’s Pamela Brown, which were originally made at a health conference in Texas last month when he said online misinformation was “now our leading cause of death.”

After admitting that there was “no way to quantify this,” before mentioning heart disease and cancer (actual killers), Califf went on to bolster the claim anyway.

Claiming that there has been “an erosion of life expectancy,” Califf went on to say that Americans were living an average of 5 years shorter than people in other high income countries.

Califf said that anti-virals and vaccinations meant “almost no one in this country should be dying from COVID,” before going on to explain that there was also a “reduction in life expectancy from common diseases like heart disease.”

“But somehow … the reliable, truthful messages are not getting across,” he said, adding, “And it’s being washed down by a lot of misinformation, which is leading people to make bad choices that are unfortunate for their health.”

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