Tag: fda

Watchdog pushes for investigation of FDA official’s conflict of interest

A disturbing article in the New York Times reveals that while a senior Food and Drug Administration (FDA) official, Jeff Shuren, M.D., J.D., was in charge of regulating medical devices, his wife’s powerful Washington law firm was representing their manufacturers.

Despite ethics rules barring Shuren, the director of the FDA’s Center for Devices and Radiological Health, from working on matters involving clients of his wife’s law firm, he did not always fully recuse himself, according to the report. In July, Shuren announced that he was transferring to the FDA’s Office of the Commissioner, and will leave the agency later this year.

Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, calls on the Office of Inspector General at the Department of Health and Human Services (DHHS) to launch an investigation amid news of these allegations. He released the following statement:

“The revelations about Dr. Shuren, the former director of the FDA’s Center for Devices and Radiological Health, are very troubling. There are long-standing concerns that the FDA’s regulation of medical devices has been too friendly to industry under Shuren’s leadership and has not prioritized patient safety and the effectiveness of novel medical devices. The Office of Inspector General at DHHS should formally investigate the allegations in the New York Times article. And the FDA must appoint a new director of the Center for Devices and Radiological Health who has no conflicts of interest and prioritizes patients’ interests.”

Keep reading

EXPOSED: Biden’s FDA pushed dangerous puberty blockers on minors even though drugs “increased risk of depression and suicidality”

An email has come to light that exposes an even greater level of evil within the Biden regime than was previously believed.

The short of it is that the Food and Drug Administration (FDA) issued a recommendation that underage children take puberty blockers for LGBT transitions, even though the agency knew full well that the drugs “increased risk of depression and suicidality” in minors.

Officially, the Biden regime does not even try to hide its support for minors taking LGBT pharmaceuticals in order to “become themselves.” Their claim, though, is that these drugs are safe for children, which we now know to be untrue.

Not only is it untrue that puberty blockers are extremely dangerous for kids, but the FDA under Biden knew this when it issued its recommendation in support of them.

Shannon Sullivan, a “Clinical Team Leader” in the Division of General Endocrinology at the FDA, admitted this in a now-unearthed email, dated Jan. 25, 2022, to fellow FDA employee Theresa Kehoe.

Sullivan explained to Kehoe in the email that a safety review on the GnRH (gonadotropin-releasing hormone) agonist class of puberty blockers, which prevent the natural release of testosterone and estrogen in developing children, had been conducted in 2016 and 2017. The review found that this particular class of puberty-blocking drugs causes a host of serious health problems both in children and adults.

“The complaints were extensive and variable, and included fibromyalgia type symptoms, infertility, PCOS, and weight gain, among others,” Sullivan wrote about the long-term effects of GnRH agonists in adults with histories of this type of drug use.

Since the review Sullivan referenced focused primarily on suicidal ideation, depression, seizures and bone health, she would go on to reveal that the effects of puberty blockers in young children are even worse.

“We did find increased risk of depression and suicidality, as well as increased seizure risk and we issued SLCs to the entire class for these AEs (added to W&P in 2017).”

Just one paragraph later, Sullivan reiterated the fact that puberty blockers are profoundly dangerous for children, but proceeds to recommend them anyway.

“… there is definitely a need for these drugs to be approved for gender transition,” Sullivan wrote, adding that one of the many reasons for this is that puberty blockers “are typically not covered by insurance and are expensive out of pocket.”

In other words, Sullivan’s view seems to be that puberty blockers are admittedly dangerous but pre-pubescent children should definitely still get them with full approval from the FDA.

Keep reading

80 Bipartisan Lawmakers Push FDA To Seriously Consider Approving MDMA-Assisted Therapy

A bipartisan and bicameral coalition of congressional lawmakers is expressing urgency to the federal government as it looks into the possibility of authorizing MDMA-assisted therapy, particularly as it concerns veterans with severe mental health conditions.

A total of 80 members of Congress—including 19 senators and 61 representatives from the House—sent separate letters to the Biden administration and the head of the Food and Drug Administration (FDA) this past week, urging serious consideration of approving the psychedelic as a treatment option for post-traumatic stress disorder (PTSD).

MDMA is “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle,” the Senate letter says, noting that FDA has already designated it as a breakthrough therapy.

This comes about a month after an FDA advisory panel rejected an application to authorize MDMA-assisted therapy. Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval and also launched an art installation memorializing military veterans who die by suicide.

“FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments,” the new letter, led by Sens. Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ) and Rand Paul (R-KY), says. “The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence.”

Keep reading

The BMGF and the FDA: working together on biodefense and population control

I had thought until now that all the bribes to FDA, CDC and NIH went to the FDA (and other) Foundations, but it seems the FDA found a way to take in the bribes directly, without any intermediaries who might interfere with how the monies are to be used…

Fits with what we learned about how FDA advises its revolving door employees that they can still influence FDA after they have taken their payoff jobs.

https://www.bmj.com/content/383/bmj.p2486

BTW, below is an incredible resource for looking at all the organizations funded by BMGF—there are so many interlocking relationships. It seems most of all of the grantees who get a lot of money also donate to the WHO, for example, and some donate back to each other. An incestuous mix.

Keep reading

How do you know the FDA is a captured agency?

How sweet—the FDA shows us a multiracial July 4 barbecue, warning us about the possibility of food poisoning when sharing food with friends. (I had to chop off the heads of the partiers so the page would fit on the screen, but believe me there was a red, white and blue theme.)

Of all the issues FDA has to deal with: food, drugs, medical devices, cosmetics, what do you think might be most important? What do you want to tell the public about?

Maybe drug shortages, or drug recalls? Drug side effects? Food recalls? Medical device problems? New drug approvals?

Nope.

First we get the kindergarten lessons, telling us the difference between hot foods and cold foods. Message: worry about your food.

Second, we hear about avian flu, though no one has ever caught avian flu from eating or drinking anything. Let no opportunity to scare people about avian flu get wasted! If you click on the page you get a bunch of fluff and this:

“Collectively, these studies provide strong assurances that the commercial milk supply is safe.”  So why even mention it?

Third, we are told to stop the spread of misinformation. Did you know that FDA has a Rumor Control service where you can be helped to snitch to social media companies about misinformation on their platforms? Isn’t this a First Amendment violation? Who knows, these day?

Keep reading

Biden’s FDA rushed COVID-19 vaccine approval for children despite experts’ appeals for more time to study negative effects

The Biden administration pressured medical professionals to rush approval of the COVID-19 vaccine for children before there was sufficient testing to ascertain its safety, experts have testified, and when top FDA vaccine experts asked for more time to study the side effects of the jabs in young adults and children, they were fired.

This is according to testimony before the House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust this week looking into the politicization of the FDA during the pandemic.

The subcommittee also released an interim staff report about the topic, “Politics, Private Interests, and the Biden Administration’s Deviation from Agency Regulations in the COVID-19 Pandemic,” which explained how the Biden administration pressured the FDA to work outside of its regulatory authority to cut corners and change procedures to push through authorization of the Pfizer jab and booster shots, which effectively enabled them to issue vaccine mandates even as concerns persisted about vaccine injury.

During the hearing, Chairman Thomas Massie (R-Kentucky) read testimony from the former director of the FDA’s vaccine office, Dr. Marion Gruber. She told the FDA’s top vaccine regulator, Dr. Peter Marks, that the vaccine needed to undergo more testing in younger people, especially males aged 12 to 17. However, Dr. Marks reportedly brushed off her concerns.

Massie recounted: “Right when they were getting the warnings that myocarditis and pericarditis are real and serious side effects to the vaccine, the top scientists at FDA had already agreed to compress the schedule as much as possible, right when they got the message that there were serious side effects.”

Keep reading

FDA advises departing staff how to influence the FDA “behind the scenes” after they’ve left

An investigation published in the BMJ on Monday reveals the “revolving door” between the US Food and Drug Administration and the pharmaceutical industry. FDA employees, including high-level officials, often leave the agency to work for pharmaceutical companies, potentially creating conflicts of interest and raising concerns about the influence of industry on regulatory decisions.

Also revealed by the BMJ investigation, from internal emails, is that staff departing the FDA are given guidance on how to lobby for industry without falling foul of US law which prohibits certain lobbying acts.

Emails obtained in response to a Freedom of Information Act request show how the FDA provides guidance to departing employees on how they can work “behind the scenes” for industry after leaving the agency and, despite restrictions on post-employment lobbying, they are still permitted to influence the agency.

The FDA’s ethics staff proactively informed these departing employees that although US law prohibits certain types of lobbying contact “they do not prohibit the former employee from other activities, including working ‘behind the scenes’.”

Keep reading

If Opiates Are Killing Americans, Why Won’t the FDA Let Us Try an Alternative?

For more than a decade, patients who’ve needed certain controlled medications have suffered from ill-advised, untenable policies the U.S. government has instituted, allegedly to mitigate the ever-surging numbers of drug overdose deaths. These policies have been a dismal failure on multiple fronts: Not only have deaths continued to surge, but the terrifying intrusion of the Drug Enforcement Administration (DEA) into the practice of medicine has had a chilling effect on patients and their physicians. 

As the DEA relentlessly tightens production quotas on medications for pain and ADHD, it has begun tracking every pill, making doctors increasingly reluctant to prescribe any controlled drugs and leaving many patients in a lurch. Perhaps worse, DEA production quotas have caused the back-order of multiple drugs—an increasingly common burden for patients, even those fortunate to have doctors willing to risk a DEA drug bust for simply doing their job.

The ill and disabled suffer the most. Virtually all patients who have diseases or chronic pain conditions will say that the emergency department is the single worst place to go for relief from severe pain. Doctors and hospitals are often more concerned about law enforcement looking over their shoulders than patient care. Patients desperate for pain relief often turn to street drugs, where they fall victim to counterfeit pills that contain fentanyl (or worse) instead of a legal opioid. 

By contrast, doctors in Australia, Canada, the United Kingdom, and throughout Europe have been using a fixed-dose, inhaled general anesthesia medicine that effectively reduces acute pain—a medication denied to Americans by a seemingly indifferent Food and Drug Administration (FDA). 

Doctors commonly used methoxyflurane (Penthrane) as a general anesthetic in the 1960s and 1970s. But, because it had toxic effects on the liver and kidneys, anesthesiologists gradually stopped using it and turned to safer anesthetics. In 2005, the FDA removed methoxyflurane from the market.

However, an Australian company, Medical Developments International, has been marketing a lower-dose, self-administered, single-use nasal inhaler version of methoxyflurane for 30 years. Its brand name is Penthrox, though many people refer to it as the “green whistle,” because of the package it comes in. People living in Europe have had access to the green whistle since 2015, and Canadian patients have had it since 2018. 

In 2020, a randomized controlled clinical trial in the U.K. demonstrated that the drug saved an average of 71 minutes in providing pain relief to accident and emergency department patients. Likewise, a 2020 Australian trial found that a methoxyflurane inhaler “was associated with clinically significant lower pain scores compared to standard therapy.” While it may cause drowsiness in some people, methoxyflurane at this low dose has few adverse effects, such as liver and kidney toxicity, and there are no reported cases of addiction or abuse. 

In 2022, the FDA finally lifted its “clinical hold” on methoxyflurane nasal inhalers and has allowed its manufacturer to resume FDA-supervised clinical trials. Unfortunately, this is an unnecessary waste of time.

Keep reading

FDA is a front organisation: There are no technicians in the buildings, no equipment and no sample testing occurs

Katherine Watt has been corresponding with a reader who is researching the history of US public health and regulatory agencies.  Records before 1973 are difficult to locate.  However, what has become clear is that the origins of these agencies are not what they make them out to be.

Why are they lying about their origins?  Because, Watt says, “they have maintained a bunch of empty office buildings that serve only as mailing addresses … There are no technicians in the buildings, there’s no equipment and no sample testing occurs.”

Katherine Watt is a mom, Catholic, and paralegal from Pennsylvania, USA. On her Substack page ‘Bailiwick News’ she documents how, since at least World War II, US Congress has been waging war on the people by passing legislation which makes it easier and easier for them to be destroyed – legally – by the pharmaceutical industry.

One of Watt’s Substack readers is researching the pre-1972 statutory and regulatory history of some of the USA’s public health agencies, including the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”).

The reason why 1972 is relevant is that in that year the regulation of biological products transferred from the NIH Division of Biologics Standards to the FDA Bureau of Biologics.  “In 1973, FDA published a consolidated set of biological product manufacturing non-regulations in the Federal Register,” Watt explained.

“Administrative rule-making by FDA since 1973 is relatively easy to locate,” she said.  However, “administrative rule-making by NIH prior to 1973 is more difficult to locate.”

Keep reading

1 In 3 Kids Have Elevated Levels Of Lead In Blood, As FDA Investigates Lead-Tainted Fruit Pouches

Many parents turn to fruit pouches whenever their children ask for a quick snack. These travel-friendly, resealable snacks are made from fruit purees designed to take the edge off your child’s hunger in a pinch.

They come in eye-catching and attractive packaging and are sweetened to suit kids’ flavor preferences.

But fruit pouches aren’t as great as they seem to be. Aside from being an inferior substitute for real fruits and fresh fruit juices, these seemingly harmless snacks can mess up your child’s health, as they are found to be contaminated with extremely high levels of lead.

FDA recalls three brands of fruit pouches due to lead contamination

In October 2023, the FDA warned parents and guardians to avoid buying WanaBana apple cinnamon fruit puree pouches, after it was discovered that the snacks contained high levels of lead.

According to the FDA:

“Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.

“Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is important to lifelong good health.”

Healthy Holistic Living reported that at least seven cases of severe lead poisoning linked to these fruit pouches were identified in more than five states, including Arizona, Louisiana, Maryland, Missouri and North Carolina.

WanaBana then voluntarily recalled their fruit puree pouches, which were sold in grocery chains like Dollar Tree as well as online retailers like Amazon.

Following these findings, the FDA also issued a recall for two more brands of fruit pouches — Schnucks cinnamon-flavored applesauce pouches and variety pack, and Weis cinnamon applesauce pouches.

Keep reading