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With New Alzheimer’s Drug, Biden FDA Is Not Following the Science

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. . .That is why the recently released results of an investigation by two House of Representatives committees into the Food and Drug Administration’s approval of Aduhelm, a drug to treat Alzheimer’s disease, are perplexing. It found that despite significant uncertainty about whether the expensive drug worked to slow or reverse patients’ symptoms, the FDA’s process for approving it was “rife with irregularities.” It concluded that the agency’s actions “raise serious concerns about FDA’s lapses in protocol.”

The report illustrates that the FDA is having problems threading the needle between Type I and Type II errors. As a longtime veteran of the agency and the author of a favorably received book about it, I can bring some insight into the issue. Here’s the bottom line: The FDA is not following the science.

I spent 15 years as the FDA’s “biotechnology czar” at a time when many of the biopharmaceutical companies were small startups needing guidance as they negotiated the regulatory maze. However, the agency’s recent involvement with biotechnology company Biogen, the manufacturer of Aduhelm, went far beyond “guidance” and was highly unusual in many ways.

At the FDA’s urging, the drug was resurrected three months after the company had canceled clinical trials because the drug appeared not to work. Subsequent developments over the next year were marked by at least 115 meetings, calls, and email exchanges between the company and the FDA, according to the report from the Oversight and Reform and Energy and Commerce committees.

Regulators assumed a major role in rebooting the company’s narrative and the effort to get the drug approved, even though there were substantial reservations about the effectiveness of the drug among several factions within the FDA, especially its statisticians, and even within Biogen. (Read more from “With New Alzheimer’s Drug, Biden FDA Is Not Following the Science” HERE)

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FDA Authorizes Bivalent COVID-19 Boosters for Children Under Age 5

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On Thursday, the U.S. Food and Drug Administration announced that it expanded emergency use authorization for the bivalent COVID-19 booster for children between the ages of six months to 5 years old.

Now, children who have received the primary two-dose COVID-19 vaccine from Pfizer or Moderna could be eligible for the third shot (via CNBC):

The eligibility rules vary depending on whether children received Moderna’s or Pfizer’s original vaccines as their primary series.

Here are the eligibility criteria:

Children 6 months through 5 years old who received Moderna’s two-dose primary series are now eligible for an omicron booster two months after their second shot.

(Read more from “FDA Authorizes Bivalent COVID-19 Boosters for Children Under Age 5” HERE)

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FDA Approves Most Expensive Drug in the World

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The Food and Drug Administration (FDA) approved a $3.5 million drug treatment Tuesday, the most expensive drug in the world.

Hemgenix, manufactured by CSL Behring, is the first gene therapy that treats adults with hemophilia B, a genetic bleeding disorder resulting in insufficient levels of a protein called Factor IX that is needed to stop bleeding. Those with severe hemophilia B are required to have regular infusions, but the new multi-million dollar gene therapy is a single-dose IV infusion, carrying a gene for blood clotting Factor IX.

“Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Around one in 40,000 people, mostly men, have the bleeding disorder. Those with hemophilia B can experience heavy or prolonged bleeding after injuries, surgeries, and dental procedures. Some with the hemophilia B even bleed for no apparent reason, and the disease can cause bleeding into joints, muscles, internal organs, and the brain. (Read more from “FDA Approves Most Expensive Drug in the World” HERE)

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

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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. (Read more from “FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation” HERE)

Photo credit: Flickr

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‘Pregnancy Is Not an Illness’: Doctors Sue FDA Over Approval of ‘Dangerous’ Abortion Pill

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Four national medical associations and four doctors are suing the Federal Drug Administration (FDA) for “illegally” approving abortion drugs that they claim harm women, according to a federal lawsuit filed Friday.

The groups, represented by Alliance Defending Freedom, are claiming that, “the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.”

The lawsuit alleges that the FDA had to designate pregnancy as an “illness” and the abortion drugs as providing a “meaningful therapeutic benefit” in order to get them approved so rapidly.

“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they end a baby’s life and they pose serious and life-threatening complications to the mother,” ADF Senior Counsel Julie Marie Blake said in a press release. (Read more from “‘Pregnancy Is Not an Illness’: Doctors Sue FDA Over Approval of ‘Dangerous’ Abortion Pill” HERE)

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New COVID-19 Boosters To Be Authorized Without Human Trials Completed

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New variant-specific COVID-19 vaccine booster doses are set to be authorized by the Food and Drug Administration (FDA) before human testing is complete.

FDA Commissioner Robert Califf tweeted last week that the agency will not hold a meeting of its expert vaccine advisers to discuss the new boosters and that it will rely on existing clinical trial data and real-world results in its determination about Emergency Use Authorizations (EUAs) for Omicron-targeting booster shots. The Centers for Disease Control and Prevention (CDC) based its fall booster rollout plan on the assumption that the new vaccines would receive EUAs by Sept. 1. . .

The typical process for granting an EUA to a new vaccine involves a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA’s group of outside experts that examines research and evidence pertaining to the vaccine’s safety and efficacy. The panel votes on whether to grant the EUA, and under what circumstances to grant it, and passes that recommendation onto the FDA commissioner for a final ruling. (Read more from “New COVID-19 Boosters to Be Authorized Without Human Trials Completed” HERE)

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Pfizer Asks FDA to Clear COVID Shots for Babies

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Children statistically have virtually no chance of death or serious illness from COVID-19, but, in any case, the experimental vaccines rushed to market under emergency use authorization have proven to be ineffective against the current SARS-CoV-2 variants while posing the risk of severe harm or death in proportions far higher than any vaccine in history.

Children also, according to studies, are at low risk of spreading COVID-19. Further, the CDC recently reported higher COVID-19 case rates have been recorded among fully vaccinated children than unvaccinated in the age group 5-11 since February 2022. And the U.K.’s Office for National Statistics found children are up to 52 times more likely to die following the COVID-19 injection than children who have not received it.

Nevertheless, Pfizer has submitted a request to the FDA – which tried to hide Pfizer’s clinical trial data for 75 years – to grant emergency use authorization to administer its COVID-19 vaccine to children from six months to 5 years of age.

The pharmaceutical giant declared in May that a three-shot regimen of its Pfizer-BioNTech vaccine was 80.3% effective in preventing COVID infections among children under 5, based on early results of its trial for that cohort. (Read more from “Pfizer Asks FDA to Clear COVID Shots for Babies” HERE)

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Strawberries Linked to Hepatitis A Outbreak

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The Food and Drug Administration, along with the Centers for Disease Control and Prevention and other agencies, are investigating an outbreak of hepatitis A that could be linked to fresh, organic strawberries sold in the United States and Canada.

Consumers should not eat strawberries from the brands FreshKampo or HEB that were sold between March 5, 2022, and April 25, 2022, the FDA said in an announcement. Health officials also warned that retailers and restaurants should not use or sell the berries.

The strawberries in question are no longer in stores. However, some buyers may have stored or frozen them for later consumption, which the FDA warns against.

The berries were sold at Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe’s, Walmart, Weis Markets, and WinCo Foods, among others. (Read more from “Strawberries Linked to Hepatitis A Outbreak” HERE)

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Shock Claim: Tester Says He ‘Pushed FDA Commissioner Months Ago’ on Baby Formula; FDA Has Known About Formula Shortage Since February

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By Breitbart. On Friday’s broadcast of CNN’s “New Day,” Sen. Jon Tester (D-MT) said that he pressed the head of the Food and Drug Administration “months ago” on the baby formula issue and stated that right now the White House is “taking appropriate steps” to fix the issue and is “taking it seriously and I think they’re moving forward in the right direction.”

Co-host John Berman asked, “What are you hearing from Montanans about baby formula?”

Tester answered, “Big concern. And we need to do everything we can do to right this ship. It’s — literally is a life and death situation in many cases.” (Read more from “Shock Claim: Tester Says He ‘Pushed FDA Commissioner Months Ago’ on Baby Formula” HERE)

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Rep. Stefanik Blasts Biden Administration for Formula Shortage, Says FDA has Known About Threat Since February

By Breitbart. The Biden Administration has been aware of the threat of a national baby formula shortage for “months,” House Republican Conference Chair Elise Stefanik (R-NY) told Breitbart News – on the same day President Biden claimed only “mind readers” could have anticipated the crisis.

Asked Friday about whether his administration could have taken steps sooner to avoid the current supply crunch of baby formula, Biden replied, “If we’d been better mind-readers I guess we could have.” . . .

But Rep. Stefanik told Breitbart News in a wide-ranging interview on Friday that Biden has been “asleep at the switch,” and that the FDA has known about a pending baby formula shortage for over three months – at least since she reached out to warn them of it in February.

“They’ve known this has been an issue for months. I sounded the alarm and reached out to the FDA in February of this year, after the recall of the Sturgis, Michigan, [Abott Nutrition] manufacturing facility, and we got no substantive response from the FDA. There was absolutely no plan from this administration about how to address that supply chain issue, which has now created even more of a crisis,” Stefanik said. (Read more from “Rep. Stefanik Blasts Biden Administration for Formula Shortage, Says FDA has Known About Threat Since February” HERE)

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FDA, Biden ‘Dropped the Ball’ on Baby Formula Crisis, Experts Say

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The FDA “dropped the ball’’ on the country’s baby-formula crisis — shutting down a crucial plant on top of product recalls and then not warning parents of the ramifications, experts told The Post on Friday.

Desperate moms and dads have been trawling stores across the country in search of baby formula ever since mega-manufacturer Abbott issued a safety recall in February for products made at its plant in Sturgis, Mich., over contamination concerns.

The Food and Drug Administration later closed the plant after federal inspectors found Abbott failed to maintain sanitary conditions and procedures there — sparking a cascade of crippling effects on the supply chain.

“Somebody, whether it be Abbott or the FDA, should have realized, ‘We’re stopping production at one of a handful of plants that produces baby formula and what are the repercussions,’ ’’ said William Marler, a lawyer specializing in food-safety cases, to The Post.

“That’s where the FDA and Abbott dropped the ball. … They could have recalled the product without shutting the facility. They do recalls all the time without shutting the facility down.” (Read more from “FDA, Biden ‘Dropped the Ball’ on Baby Formula Crisis, Experts Say” HERE)

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