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July 20, 2022

Health Experts Quit Over “Bad Science”

The National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) are facing staffing shortages due to “bad science.”

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” an unnamed senior FDA official told Common Sense. “People are getting bad advice and we can’t say anything.”

An unnamed NIH scientist told the outlet: “They have no leadership right now. Suddenly, there’s an enormous number of jobs opening up at the highest level positions.”

The publication noted that the people they spoke with agreed to be quoted anonymously, for fear of professional repercussions.

“I used to be proud to tell people I work at the CDC. Now I’m embarrassed,” a scientist at the CDC said.

What’s causing the embarrassment? According to Dr. Marty Makary, a top public-health expert at Johns Hopkins University, “In short, bad science.”

Makary continued:

“The longer answer: that 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.”

Last month, Dr. Rochelle Walensky, CDC director, said that everyone six months or older should receive the mRNA covid vaccines.

But some health experts are alarmed by the recommendation.

“The public has no idea how bad this data really is. It would not pass muster for any other authorization,” a high-level FDA official said.

Makary said the data submitted by Pfizer and Moderna to receive emergency approval for their COVID-19 vaccines was lacking. Pfizer’s trial included under 1,000 children and didn’t show any efficacy against infection, he said. Moderna’s trial included roughly 6,000 children and reported a 4% reduction in infection.

“It seems criminal that we put out the recommendation to give mRNA covid vaccines to babies without good data. We really don’t know what the risks are yet. So why push it so hard?” a CDC physician said.

“A more honest announcement would have been: ‘We approved the vax for babies & toddlers based on very little data. While we believe its safe in this population, the study sample size was too low to make a [conclusion] about safety. Note that studies were done in kids without natural immunity,” Makary told DailyMail.com.

February 17, 2022

Senate Confirms Biden’s Controversial Pick

The Senate narrowly confirmed President Joe Biden’s pick to head the Food and Drug Administration amid political controversies that threatened to derail his confirmation.

A vote of 50-46 confirmed Dr. Robert Califf, a cardiologist and prominent medical researcher, as the FDA’s leader, a position he briefly held during the Obama administration.

Several Republicans crossed party lines to support Califf’s confirmation, including Sens. Mitt Romney (UT), Mitch McConnell (KY), and Richard Burr (N.C.).

“He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life with the approval of tests, vaccines and therapeutics that are bringing the pandemic to an end,” Burr said of Califf.

“He’s the leader we need today, but also for the future.”

Conversely, several Democrats opposed Califf’s appointment, citing his ties to Big Pharma and handling of the opioid crisis under former President Barack Obama.

“What started as an OxyContin prescription for back pain became full-blown dependence on heroin for countless Americans,” said Sen. Ed Markey (D-MA), who voted against the confirmation.

“The FDA continued to approve powerful new opioids either over the express objections of its own advisory committees or without convening an advisory committee at all. The FDA became the country’s biggest pill pusher [and] Big Pharma made billions in profits,” he continued.

“We cannot forget how we reached this epidemic in the first place, or we are doomed to repeat it for those families.”

“Those failures started at Big Pharma and were aided and abetted by the Food and Drug Administration,” Markey concluded.

Moderate Democrat Sen. Joe Manchin (W.VA.) was one of Califf’s most outspoken detractors, railing against the pharmaceutical industry for its role in the opioid crisis.

“We have insight into how he will lead the agency. [During] Dr. Califf’s previous tenure, drug-related overdoses went up. Five years later, they’re up again, and this time at record numbers,” Manchin said ahead of the vote.

“In fact, despite his pledge to overhaul the FDA policy, during his tenure and immediately following it, the FDA approved five new opiates for the market, and at the same time, they removed only one.”


Source:

Senate confirms Biden’s FDA pick despite political divisions

December 24, 2021

Buyer Beware: Packaged Salads Recalled in 19 States

Fresh Express has recalled products from 19 states while the Food and Drug Administration (FDA) investigates a deadly outbreak related to the packaged salads that killed at least one person.

The company announced in a press release that products from its factory in Streamwood, Illinois, are potentially contaminated with the bacteria Listeria monocytogenes. The Michigan Department of Agriculture conducted a random sample and found one packaged salad containing the bacteria.

Recalls were made in the following states: Connecticut, Illinois, Kentucky, Maryland, Maine, Indiana, Rhode Island, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Wisconsin, North Dakota, Minnesota, Michigan, Iowa, and Massachusetts.

According to FDA, the recalled products include all use-by-date fresh salad packages with the product codes of Z324 through Z350.

The FDA announced a probe into a “multistate outbreak” linked to the Fresh Express products.

According to FDA Deputy Commissioner for Food Policy and Response Frank Yiannas, ten people infected with the outbreak strain have been reported from eight states while one person has died.

“We will continue to work with our partners and with Fresh Express to determine the source of this outbreak,” Yiannas said. “We remain committed to transparency and providing updates as we learn more during our continuing traceback investigation.”


Source:

Fresh Express Announces Recall of Fresh Salad Products Due to Potential Health Risk

December 19, 2021

FDA Permanently Allows Abortion Pills By Mail [Video]

The Food and Drug Administration (FDA) decided that Americans can permanently receive abortion pills by mail, lifting a restriction that required individuals to get the pills in person from a physician.

The move comes amid the likelihood that the Supreme Court will overturn Roe v. Wade, a 1973 decision that made abortions legal in the U.S.

Abortion pills enable patients to undergo a medical abortion at their homes up through 10 weeks of pregnancy. Patients first take mifepristone, which stops the pregnancy from continuing, and then up to 48 hours later, they take misoprostol, which causes uterine contractions.

However, 19 states have already banned telemedicine visits for abortions. Five states, including Missouri, Arkansas, and Louisiana, have outright bans on using telemedicine for abortion pills, while the other 14 — which includes Texas, Mississippi, and Alabama — require patients to visit a physician in person. 

Planned Parenthood put out a statement on the FDA’s announcement, calling the decision a “victory for public health and equity.”

“We’ve seen very clearly in the past two years that the logistical hurdle of unnecessary travel to health centers during a dangerous pandemic only creates more barriers to care, especially for people of color and people with low incomes,” said Alexis McGill Johnson, the president and CEO of Planned Parenthood. “Abortion is time-sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion.”

“With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”


Source:

FDA says abortion pills can be sent by mail

September 19, 2021

FDA overwhelmingly rejects Pfizer booster for anyone 16 and up

An advisory panel for the Food and Drug Administration resoundingly voted against giving Pfizer-BioNtech’s COVID-19 booster shots to those 16 and up. The panel agreed to distribute them only to people aged 65 and those at high risk of severe illness.

Members overwhelmingly voted against the recommendation for everyone 16 and older, citing concerns about the lack of evidence showing boosters are safe and effective for young people.

“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit.

The recommendation only applies to those who received the Pfizer vaccine and does not impact those who received Moderna or Johnson & Johnson.

Source:

FDA advisory group rejects Covid boosters for most, limits to high-risk groups

September 14, 2021

Resigning FDA advisers say COVID-19 boosters unnecessary for most

An international group of scientists says that current evidence doesn’t indicate a general need for COVID-19 vaccine booster shots. The group includes two senior Food and Drug Administration (FDA) officials who are reportedly resigning from their positions over a disagreement with the Biden administration on COVID-19 boosters.

The researchers published their findings in The Lancet on Monday, arguing that the data is too insufficient to implement a widespread booster protocol.

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” the authors wrote. “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

Among the researchers are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause. Gruber will step down in October, and Krause will follow suit in November.

Source:

COVID-19 vaccine boosters unnecessary for most, say FDA advisers reportedly resigning over issue

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