Tag: fda

FDA Stayed Silent As Internal Reports About Potential Tylenol Risks Piled Up

The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the Daily Caller News Foundation reveal.

FDA rank-and-file scientists repeatedly recommended the agency release information about Tylenol in pregnancy across three scientific reviews conducted in 2016, 2019, 2022 and two memos, one from the FDA’s maternal health division in 2016 and one from the FDA’s urological health division in 2017.

The scientific literature posits many plausible drivers of autism, the most well-established of which are genetic, and the FDA drug safety experts acknowledged that the research linking the condition to Tylenol is far from ironclad.

Still, as alarm bells rang within FDA headquarters and the boardrooms of Tylenol’s manufacturers, pregnant women heard nothing from either the government or the manufacturers about the potential risks until the September announcement by President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr.

FDA leadership declined to update its webpage about over-the-counter painkillers in pregnancy, repeatedly falling back on language first issued in January 2015. But that statement simply acknowledged that “FDA is aware of concerns” about Tylenol and attention deficit hyperactivity disorder (ADHD), citing just one scientific paper.

At the urging of Trump and Kennedy, FDA finally released a nuanced statement in September cautioning pregnant women about Tylenol while acknowledging that aspirin, ibuprofen and high fevers all pose their own risks. That move was first recommended by an FDA drug safety expert nine years earlier.

The DCNF obtained the FDA documents from the law firm Keller Postman LLC, which brought a class action lawsuit against Tylenol maker Kenvue, a legally independent spinoff of Johnson & Johnson. The personal injury law firm, which often brings class action lawsuits, obtained the documents from FDA via the Freedom of Information Act.

Tylenol, a brand name for acetaminophen, first received FDA approval in 1955 before modern drug laws tightened clinical trial requirements in 1962.

Some experts argue that neurological damage occurs due to a toxic byproduct of acetaminophen called NAPQI. Babies and children with autism may struggle to metabolize the drug, resulting in higher levels of NAPQI, which kills cells.

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Pfizer Left COVID-19 Vaccine Data Out Of Submissions To FDA, Documents Show

Data on how parts of a Pfizer-BioNTech COVID-19 vaccine spread in the bodies of mice were withheld from regulatory submissions to the U.S. Food and Drug Administration, according to a new comparison of those submissions and similar documents sent to Japanese regulators.

Byram Bridle, who has a PhD in immunology and is an associate professor of immunology and virology at the University of Guelph in Canada, authored the comparison. It was dated Aug. 13 and released on Oct. 4 by Dr. Robert Malone, a vaccine adviser to the U.S. government.

“The findings of this report raise serious questions about the integrity of the health regulatory process during the declared COVID-19 pandemic,” Bridle said in his conclusions.

During a September meeting, under questioning by Malone, a Pfizer representative said that its studies of the spread of vaccine elements, known as biodistribution, were done in consultation with the FDA.

“Pfizer does not have a further comment other than we did our work in close consultation with the FDA on all our of biodistribution studies that were approved for our licensed product,” the representative said.

As Zachary Stieber details below, Malone told The Epoch Times that the images in the submissions appear to have been manipulated “to hide the fact that the biodistribution was much broader than the initial narrative that was promoted, which is that it stays at the site of injection and draining lymph nodes.”

He added: “That was clearly a lie, and it was a lie that we now know was supported by editing data that were presented to the FDA. And, according to what the Pfizer representative stated, that editing of data was done in cooperation and consultation between Pfizer and the FDA. That is completely unacceptable.”

Pfizer, BioNTech, and the FDA did not respond to requests for comment.

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Self-Monitoring Blood Glucose Meters Recalled Due to Potentially Defective Displays: FDA

Florida-based Trividia Health Inc. is recalling a limited number of blood glucose meters because of potentially defective liquid-crystal displays that could affect product performance, the company said in an Oct. 7 statement published by the Food and Drug Administration.

The recall applies to Trividia’s True Metrix self-monitoring glucose meters that are co-branded under the Good Neighbor Pharmacy brand. The affected items belong to lot number KD0746, printed on the side of the product box. They were manufactured on Sept. 4 and sold between Sept. 8 and 16 across the United States.

“It is possible that the LCD display for the affected products may show partial or missing numerical segments or characters or show ghosting (fading) of numerical segments or characters,” the company said. “As a result, it is possible that users could misinterpret a test result or experience a delay in obtaining test results. For users with low glucose (hypoglycemia), this could result in a delay in treatment or therapy decisions.”

According to Trividia, it has so far not received any reports of people suffering injuries as a result of using the recalled products.

The company said it was sending notifications to customers, including pharmacies, to inform them of the issue.

“If you have an affected Product, the Trividia Health Customer Care Department will help with return and replacement information,” it said.

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Former FDA Vaccine Chief Peter Marks Joins Pharmaceutical Company

Dr. Peter Marks, who formerly led the Food and Drug Administration’s oversight of vaccines, has joined the pharmaceutical firm Eli Lilly, the company told The Epoch Times on Oct. 7.

“Lilly continually evaluates breakthrough science which could benefit patients. Peter’s expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas,” a spokesperson for the company told The Epoch Times via email.

Marks is the senior vice president of molecule discovery for Lilly, and the head of its infectious disease unit.

Lilly does not currently make any vaccines for the U.S. market.

Marks, who has a medical degree and a graduate degree in cell and molecular biology, was director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, for years before resigning in April. Marks cited disagreements with Health Secretary Robert F. Kennedy Jr.

Marks sped up the first COVID-19 vaccine approval because he wanted to enable vaccine mandates and have more people vaccinated, according to internal documents, prompting two other FDA vaccine officials to resign. Marks has said the officials were not moving fast enough in light of the pandemic situation.

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After Massive Shrimp Recalls, the FDA Finds Radioactive Contamination in Spices Too

Federal regulators have detected possible radioactive contamination in a second food product sent to the U.S. from Indonesia, even as recalls of potentially tainted shrimp continue to grow. The discovery adds to questions about the source of the unusual problem.

U.S. Food and Drug Administration officials last week blocked import of all spices from PT Natural Java Spice of Indonesia after federal inspectors detected cesium 137 in a shipment of cloves sent to California.

That follows the import alert imposed in August on the company PT Bahari Makmuri Sejati, or BMS foods, which sends millions of pounds of shrimp to the U.S. each year.

Here’s what you need to know about potential cesium 137 contamination:

What is cesium 137?

Cesium 137 is a radioactive isotope created as a byproduct of nuclear reactions, including nuclear bombs, testing, reactor operations and accidents. It’s widespread around the world, with trace amounts found in the environment, including soil, food and air.

What have U.S. officials found?

U.S. Customs and Border Protection officials detected cesium 137 in shipping containers of shrimp sent by PT Bahari Makmur Sejati to several U.S. ports. CBP officials flagged the potential contamination to the FDA, which tested samples of the shrimp and detected cesium 137 in one sample of breaded shrimp.

The company has sent about 84 million pounds (38 million kilograms) of shrimp to U.S. ports this year, according to data from Import Genius, a trade data analysis company. It supplies about 6% of foreign shrimp imported in the U.S.

This month, FDA officials detected cesium 137 in one sample of cloves exported by PT Natural Java Spice, which sends spices to the U.S. and other countries. Records show the company sent about 440,000 pounds ( 200,000 kilograms) of cloves to the U.S. this year.

What are the health risks?

No food that triggered alerts or tested positive has been released for sale in the U.S., FDA officials emphasized.

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FDA Considering Independent Evaluation for DNA Contamination in COVID-19 Vaccines

The Food and Drug Administration is mulling over conducting its own evaluation of the levels of DNA in COVID-19 vaccines, an FDA official has disclosed.

“I’ll say that that is something that’s being discussed,” Dr. Tracy Hoeg, a senior adviser to the FDA’s commissioner, told members of the Centers for Disease Control and Prevention’s vaccine advisory panel on Sept. 19.

Before the panel’s members unanimously recommended during the meeting that the CDC roll back COVID-19 vaccine recommendations, a number expressed concerns about growing evidence of higher-than-allowed levels of DNA in the vaccines, the spreadofthevaccinebeyond the injection site, and the long-term persistence of messenger ribonucleic acid (mRNA)—a key part of the Pfizer-BioNTech and Moderna shots.

The CDC has described mRNA as the entity teaching cells how to make copies of the spike protein to enable protection when the real virus, with its own spike protein, attacks the body. “After the mRNA delivers the instructions, your cells break it down and get rid of it,” a CDC graphic states.

Retsef Levi, chair of the advisory panel’s COVID-19 immunization workgroup, showed the graphic during the meeting.

“We have a range of things on the mRNA platforms that really suggests that it doesn’t work as intended,” Levi said, citing issues such as the spread of spike protein and mRNA into various parts of the body and “DNA contamination.”

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FDA Warns Companies Against False and Misleading Drug Ads

Federal regulators sent dozens of letters to companies in September warning them that their advertisements for drugs are misleading and could lead to repercussions unless fixed.

The Food and Drug Administration on Sept. 16 released 65 letters it sent on Sept. 9 to companies, including Eli Lilly and Novo Nordisk. President Donald Trump signed a memorandum that day directing officials to enforce existing rules surrounding direct-to-consumer advertising for drugs.

In letters to Eli Lilly, FDA officials said that advertisements for weight loss products, including one that originally appeared in a special held by Oprah Winfrey, did not present people with accurate information about possible side effects.

The ad that aired during the Oprah special “creates a misleading impression regarding the safety of Zepbound and Mounjaro, which are drugs with multiple serious, potentially life threatening risks,” officials with the FDA’s Center for Drug Evaluation and Research said in one of the letters. They said that people who seek medical treatment for obesity or Type 2 diabetes “should receive truthful and non-misleading information.”

An Eli Lilly spokesperson told The Epoch Times in an email: “FDA’s correspondence to Lilly addresses three interviews conducted by independent media outlets. These interviews were not advertisements, and Lilly had no editorial control over them.

“We remain committed to providing patients with accurate, reliable information that empowers them to make informed healthcare decisions in partnership with their physicians.”

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FDA targets Hims & Hers, posts more than 100 letters to drugmakers

The Trump administration is cracking down on pharmaceutical advertising and they are specifically targeting telehealth companies that promote unofficial versions of weight loss medications.

More than 100 letters were posted by the Food and Drug Administration to drugmakers and online prescribing companies. Hims & Hers built a multibillion-dollar business around weight loss interventions. The letters warned the companies, including Hims & Hers, to remove “false and misleading ” promotional statements and advertising from their website.

Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.

Hims said Tuesday that it “looks forward to engaging with the FDA.”

“Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the company said in a statement.

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Trump FDA to Present Data Linking COVID Jabs to Child Deaths at Upcoming CDC Meeting

The Food and Drug Administration (FDA) will present data linking COVID-19 vaccines to the deaths of dozens of children.

According to several media reports, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Thursday and Friday to review and recommend several vaccines, including this fall’s updated Covid shots.

The FDA is basing its claim on data from the Vaccine Adverse Event Reporting System (VAERS), a public database run jointly by the FDA and CDC.

The reports come after FDA Commissioner Marty Makary told CNN last week that the agency is investigating reports of healthy children dying after receiving Covid vaccines.

“We’ve been looking into the VAERS database of self-reports that there have been children that have died from the Covid vaccine,” Makary said.

“We’re going to release a report in the coming few weeks and we’re going to let people know. We’re doing an intense investigation.”

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FDA Chief Says No Solid Evidence Supporting Hepatitis B Vaccine At Birth

The head of the Food and Drug Administration said on Sept. 8 that there is no strong evidence supporting the administration of a hepatitis B vaccine to infants.

“I personally don’t believe that the evidence is solid to say the Hep B shot needs to be given at birth,” Dr. Marty Makary, the FDA commissioner, said during an appearance on Fox News.

“It’s totally different from polio and measles, and some of these other shots that are tried and true and have been around for a long time.”

The FDA, which is part of the Department of Health and Human Services, has cleared hepatitis B vaccines to be administered at birth. The Centers for Disease Control and Prevention recommends that all infants receive a hepatitis B vaccine on the day they are born.

A debate among some doctors regarding the recommendation has been taking place in light of the CDC vaccine advisory panel’s scheduled discussion on the hepatitis B vaccination at its upcoming meeting.

“I predict that what they’re going to do is try to change the birth dose of hepatitis B vaccine so that kids don’t get it when they’re born,” Dr. Demetre Daskalakis, who recently resigned from the CDC, said during an appearance on ABC.

The panel makes recommendations on vaccines. The recommendations are usually adopted by the CDC.

Hepatitis B is a liver infection that can lead to liver failure and death, although some of those infected never experience symptoms. Hepatitis B is contracted through contact with the bodily fluids of an infected person. Babies who are born to infected women can also contract it.

The CDC first recommended the hepatitis B vaccine in 1982, the year after it was cleared, for people deemed to be at high risk, such as drug users, pregnant women, and infants born to mothers who had hepatitis B.

By 1992, the recommendation for infants shifted to the first day of life and was broadened to all newborns because of “the difficulty of vaccinating high-risk adults,” according to the CDC.

Three doses of the vaccine are on the CDC’s childhood immunization schedule, and nearly every state requires hepatitis B vaccination to attend school and/or childcare facilities.

The stated goal of the vaccination campaign was to eliminate transmission of hepatitis B, which has not happened.

“We’re giving about 11 million doses of hepatitis B a year, and pretty much all of them are for kids who we know don’t need it,” since their mothers have been screened, Dr. Monique Yohanan, a senior fellow at Independent Women’s Forum, told The Epoch Times in a recent interview.

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