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MEDICINE AND HEALTH

Doctor Crashes FDA Meeting And Shares the Whistleblower Story They Ignored By Debra Heine

https://amgreatness.com/2022/04/08/doctor-crashes-fda-meeting-and-shares-the-whistleblower-story-they-ignored/

A doctor “crashed” a Food and Drug Administration’s meeting with outside vaccine experts earlier this week, to share a whistleblower’s story about the data integrity issues that plagued one of Pfizer’s clinical trials.

In September of 2020, a researcher from an organization testing Pfizer’s vaccine at several sites in Texas, emailed a complaint to the FDA, informing the agency of the company’s dangerously shoddy research practices. The FDA took no action on her email, and Pfizer continues to use the company.

Last week, the FDA authorized a second round of booster shots for people 50 and older and for those with certain immunocompromising conditions.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in an open session on April 6 to discuss “considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.”

Dr. Peter Doshi, an assistant professor of pharmaceutical health services at the University of Maryland, and an associate editor at The British Medical Journal (BMJ), took the opportunity to tell the whistleblower, Brook Jackson’s, story.

In the fall of 2020, Jackson was the regional director for the Ventavia Research Group, the company that was conducting Pfizer’s pivotal phase III trial in Texas. She told the BMJ last November that she witnessed researchers falsifying data, unblinding trial participants, and employing inadequately trained vaccinators. She also said researchers were slow to follow up on adverse events.

Jackson has submitted her evidence to a federal court.

During an interview with the Blaze’s Daniel Horowitz in February, the whistleblower said Pfizer’s clinical trials were so riddled with fraud and abuse of the scientific process there was zero credibility left.

The CDC finds a depression epidemic among teens — that it created By Sam Munson

https://nypost.com/2022/04/05/the-cdc-created-a-depression-epidemic-in-our-teenagers/

The Irish poet W.B. Yeats wrote of sailing to an imagined Byzantium because his was “no country for old men.” The pandemic has proven that the United States is no country for the young.

A new Centers for Disease Control study reveals how badly teens have suffered from COVID policies — that the CDC itself pushed.

Many of us have lamented the terrible damage done to younger children by school closures and mask mandates — years of learning loss that may never be made up. Now we learn that the isolation and anxiety that accompanied school shutdowns have taken a heavy toll on adolescents.

The CDC found that more than a third of US high-school students reported poor mental health during the pandemic. Nearly half — 44% — said they felt sad or hopeless. A horrifying near-20% said they had seriously considered suicide in the previous 12 months.

The lifeline for those who made it through unscathed? Per the CDC data, it’s an obvious one: a feeling of “school connectedness.”

Teens who felt connected to both adults and their school buddies were far less likely to experience those feelings of sadness or despair: 35% vs 53%.On suicidal thoughts, the numbers are even starker, with 14% who felt connected having such thoughts vs. 26% of those who didn’t. And when it comes to actual suicide attempts, 6% of those who felt connected made the attempt vs. 12% of those who didn’t.

France’s Academy of Medicine Urges ‘Great Medical Caution’ in Blocking Puberty

https://www.nationalreview.com/corner/frances-academy-of-medicine-urges-great-medical-caution-in-blocking-puberty/

The Biden administration acts as if “the science” supports “gender affirming care” — i.e., puberty blocking, hormone administration, and even mastectomies and genital surgeries — as clearly the best approaches to treating children and adolescents diagnosed with gender dysphoria.

But that isn’t true. The brakes are being put on this approach in the U.K., Sweden, and Finland. And now, France’s National Academy of Medicine is holding up a big “SLOW DOWN!” sign on joining the transgender moral panic. Specifically, it warns that these interventions might not be warranted and have potentially significant deleterious potentialities. Moreover, there has been a worrying explosive increase in the number of cases. From the translated press release:

While this condition has long been recognized, a sharp increase in demand for medical interventions has been observed first in North America, then in Northern Europe, and, more recently, in France, particularly among children and adolescents. A recent study of a number of high schools in Pittsburgh revealed a prevalence that is clearly higher than previously estimated in the United States: 10% of students declared themselves to be transgender or non-binary or were unsure of their gender. In 2003, the Royal Children’s Hospital in Melbourne diagnosed only one child with gender dysphoria, whereas today it treats nearly 200.

It used to be infinitesimal! More:

Whatever the mechanisms involved in adolescents — excessive engagement with social media, greater social acceptability, or influence by those in one’s social circle — this epidemic-like phenomenon manifests itself in the emergence of cases or even clusters of cases in the adolescents’ immediate surroundings. This primarily social problem is due, in part, to the questioning of an overly dichotomous view of gender identity by some young people.

Woke Medicine’s Got a Tricky Operation Coming Up: Grafting ‘Systemic Racism’ Onto Hard Science By John Murawski

https://www.realclearinvestigations.com/articles/2022/04/05/woke_medicines_got_a_tricky_operation_coming_up_grafting_systemic_racism_onto_hard_science_824726.html

Just a few years ago, concepts such as “white supremacy,” “systemic racism,” and “structural intersectionality” were not the standard fare of prestigious medical journals. These are now the guiding ideas in a February special issue of “Health Affairs” that focuses on medicine and race.

Featuring nearly two dozen articles with titles such as “Racism Runs Through It” and “Sick and Tired of Being Excluded,” as well as a poem called “Identity,” the Washington, D.C.-based, peer-reviewed journal analyzes racial health disparities not through biology, behavior, or culture, but through the lens of  “whiteness,” along with concepts such as power, systems of oppression, state-sanctioned violence, and critical race praxis – a sampling of terms that come up in the February issue.

Health Affairs, dubbed by a Washington Post columnist as “the bible of health policy,” represents something much more ambitious than woke virtue signaling. Its February issue reflects the effort of newly empowered “anti-racist” scholars to transform concepts that are still considered speculative and controversial – and some say unprovable – into scientific fact. This growing effort to document, measure, and quantify racism is being advanced by other high-profile publications, including The New England Journal of Medicine, The Journal of the American Medical Association, and Scientific American, which last year ran articles entitled “Modern Mathematics Confronts Its White, Patriarchal Past” and “Denial of Evolution Is a Form of White Supremacy.”

But this scientific aspiration faces major challenges. Science demands verification, testability, and replicability, whereas race is a social construct that can be difficult to separate from factors like class or culture, and explaining the data often remains dependent on academic theories about systemic racism. The articles in Health Affairs indicate that elevating the concept of systemic racism from moral certitude to scientific fact will require developing new tools and methods – and even more theories – in the face of skepticism and resistance from dissenters who view this direction in research as unscientific and ideological.

THE CDC MASSIVELY VIOLATES ITS PLEDGE TO AMERICANS. WHY TRUST IT NOW?

https://issuesinsights.com/2022/04/05/the-cdc-massively-violates-its-pledge-to-americans-why-should-anyone-trust-it-now/

(Since Big Tech is likely to try to censor this article, we encourage our readers to share it widely with friends by email, on personal websites, blogs, or however else you share information these days.)

One of the five items on the CDC’s “Pledge to the American People” is that it will “base all public health decisions on the highest quality scientific data that is derived openly and objectively.” Can anyone honestly say that it has lived up to this promise during the COVID outbreak?

Three recent events should make it abundantly clear that the answer is no.  

First, the CDC has been caught hiding vast amounts of scientific data regarding COVID. The New York Times, of all places, reported in late February that “For more than a year, the Centers for Disease Control and Prevention has collected data on hospitalizations for COVID-19 in the United States and broken it down by age, race and vaccination status. But it has not made most of the information public.” Why? Because the data, especially data on the efficacy of vaccines, “might be misinterpreted.”

Dr. Nicole Saphier, a physician at Memorial Sloan Kettering, tweeted in reaction to the news that: “The CDC’s response when questioned about their withholding of COVID data and lack of transparency is essentially ‘we don’t trust you to be able to understand the truth.’ The condescension is palpable.”

She added that “People who have blindly trusted the CDC the last 2 years are about to have their world turned upside down as the lack of transparency and manipulation of data become undeniably evident.”

So much for the CDC’s pledge to be “open and objective.” (This revelation also shows that the CDC has violated another of its pledges: to “treat all persons with dignity, honesty, and respect.”)

FDA Shuts Out Its Own Experts in Authorizing Another Vaccine Booster Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. By Marty Makary

https://www.wsj.com/articles/fda-shuts-out-its-own-experts-in-authorizing-another-booster-covid-vaccine-pandemic-science-11649016728?mod=opinion_lead_pos7

The Food and Drug Administration last week authorized Americans 50 and over to get a fourth Covid vaccine dose. Some of the FDA’s own experts disagree with the decision, but the agency simply ignored them. It will convene its advisory committee this Wednesday to discuss future vaccine needs. That’s like having lawyers present arguments to a judge who’s already issued a verdict.

Eric Rubin, editor in chief of the New England Journal of Medicine, sits on the advisory committee. He told CNN last month that he hadn’t seen enough data to determine whether anyone needs a fourth dose whose immune system isn’t seriously deficient.

Another committee member, Cody Meissner, agrees. Dr. Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, told me last week that the fourth dose is “an unanswered scientific question for people with a normal immune system.”

A third member of the committee, Paul Offit of the Children’s Hospital of Philadelphia, told the Atlantic that he advised his 20-something son to forgo the third shot, which the FDA recommends for everyone 12 and over.

At the crux of the broad opposition to second boosters is the recognition of B- and T-cells, which public-health officials have long ignored. They talk only about antibody levels, which tend to decline in the months after vaccination. B- and T-cells, activated by the primary vaccine series or an infection (and augmented by a single booster in older patients), are highly and durably effective at preventing serious illness from Covid. An additional vaccine dose induces a fleeting high in antibody levels, offering only mild and short-lived protection against infection.

Medical experts question feds’ evidence for second COVID booster, refusal to consult advisers CDC now has “civic duty to rigorously study the long-term effects of vaccine-induced myocarditis,” National Academy of Medicine member says By Greg Piper

https://justthenews.com/government/federal-agencies/medical-experts-question-fdas-evidence-second-covid-booster-refusal

he federal government’s enthusiasm for COVID-19 vaccine boosters is not matched by some of its outside advisers and other medical professionals, including the head of a leading medical journal who questions the evidence behind the decisions in the past several months.

The Food and Drug Administration on Tuesday authorized a fourth mRNA dose for ages 50 and older, expanding its availability beyond immunocompromised people, without input from its Vaccines and Related Biological Products Advisory Committee.

The Centers for Disease Control and Prevention followed hours later without consulting its Advisory Committee on Immunization Practices.

The FDA previously overruled VRBPAC in November by authorizing a third mRNA dose for ages 16 and older. The agency’s top two vaccine officials, Marion Gruber and Philip Krause, resigned earlier in the fall when the Biden administration promoted boosters for all adults before the agency could weigh in.

Johns Hopkins University medical professor Marty Makary, a member of the National Academy of Medicine, asked sarcastically whether “bypassing the typical voting process” of the VRBPAC was “following the science.”

Instead, the agency plans to convene its outside experts to “discuss” the FDA’s decision, which is like “a judge issuing a verdict and then having lawyers make their arguments,” Makary wrote in a tweet thread.

“There is zero clinical data that a 4th dose reduces hospitalization risk,” he said. “There isn’t even any evidence that a 3rd dose reduces hospitalization risk in young people.”

VRBPAC member Eric Rubin, editor in chief of The New England Journal of Medicine, told CNN he has only seen fourth-dose data “for participants followed for just a few weeks.” The committee needs to know how well it protects “highly vulnerable people against serious disease and death.”

Social-Justice Activism Invades Medical School By George Leef

https://www.nationalreview.com/corner/social-justice-activism-invades-medical-school/

“These “social justice” moves won’t improve medical care; they will waste time and resources on ideological distractions.”

Almost none of the people who run educational institutions in America these days can resist the temptation to signal their virtue (and curry favor with various interest groups) by embracing “social justice,” “anti-racism,” and other leftist tropes. It was bad enough when it was happening in English departments, but now we find it in more worrisome places, such as medical schools.

The University of North Carolina’s medical school is one of them and in today’s Martin Center article, John Sailor examines the controversy.

After criticism of the school’s initial announcement of its new initiatives, it released an “Update” document. Sailor finds that document to be neither clarifying nor relieving. He writes, “Many of the recommendations flirt with violating academic freedom. They include ‘Revise Promotion and Tenure Guidelines to include a social justice domain required for promotion’ and ‘Directors of all phases will begin to examine and change content as needed to include anti-racist concepts as defined in the objectives.’”

Most Americans Are Moving On from Covid. Progressive Elites Aren’t By Nate Hochman

https://www.nationalreview.com/2022/03/most-americans-are-moving-on-from-covid-progressive-elites-arent/

Mandates and masks and fear are no longer normal — unless you read or write for the New York Times.

T he chaotic news cycle in Ukraine has overshadowed a significant development domestically — the drastic shift in public opinion on Covid-19 precautions. “Two years after the start of the pandemic, the nation is ready to move on,” Axios reported last week. “64% of survey respondents now favor federal, state and local governments lifting all COVID-19 restrictions, up 20 percentage points since early February.” (Although “three in four say they’d go back to masking if infections increase again where they live,” it noted.) On top of that, “84% say their state of emotional well-being is good, the highest shares for both since May 2020.” And “75% said the country is moving toward a time when COVID won’t interrupt daily life, up from 66% last month.”

Notably, it’s Democrats who are reporting the largest shift in views toward the pandemic. According to recent numbers from Morning Consult, “the share of adults who say COVID-19 is a severe health risk in their local community fell to an all-time low of 17%, driven by a roughly 20-point decrease among Democrats in recent weeks. Just under a quarter of Democrats now say COVID-19 is a severe local risk, compared with 12% of Republicans, a level that has also fallen since late January.” From January 14 to March 13, the share of American adults who see Covid as a “severe” health risk fell 17 points, from 34 to 17 percent. Among Republicans, that number fell 11 points, from 23 to 12 percent. But among Democrats over that time period, it fell 23 points, from 46 to 23.

In New York City, the leftist war on children continues under a new health tsar By Andrea Widburg

https://www.americanthinker.com/blog/2022/03/in_new_york_city_the_leftist_war_on_children_continues_under_a_new_health_tsar.html

If there are only two things that the last two years have taught us, they are (1) that young children do not get extremely sick or from COVID nor do they spread it, and (2) that cloth and paper masks are ineffectual against a virus. However, New York City’s new health commissioner, Ashwin Vasan, doesn’t let little things like facts get in the way. He’s doubled-down on keeping children five and under smothered in masks for the indefinite future, even as mandates for adults are finally going away. Because there is no health reason behind it, the only reason, a sinister one, can be to train both children and their parents to obey the government at all times.

The Daily Mail has the story:

New York City‘s new health commissioner sparked outrage after announcing that children aged five and under should wear face masks indefinitely, bucking the national trend of ditching masks and going in the face of vast evidence that kids are at little risk from Covid-19.

‘I think it’s indefinite at this point,’ Dr. Ashwin Vasan said Friday during a COVID-19 briefing in Queens. ‘People who have tried to predict what’s going to happen in the future in this pandemic have repeatedly found egg on their face, as they say, and I’m not going to do that here today.’

The woke commissioner, who lives in Brooklyn with his partner and three children, including a four-year-old son, argued he wanted to mask children because under fives are not vaccinated.