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Tag: kakistocracy

Inside the Collapse of the F.D.A.

The reckoning that Robert Califf spent years warning about began, as so many things seem to these days, on social media. It was October 2024. His tenure as commissioner of the Food and Drug Administration was winding down, and he was starting to imagine a happy retirement surrounded by grandchildren when he noticed Robert F. Kennedy Jr. taking aim at his agency, and the 19,000 or so people who worked there, on X.

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you. 1. Preserve your records, and 2. Pack your bags.”

It was a confused, almost comically pompous declaration, Califf recalls thinking, and it ought to have been the least of his concerns. Kennedy had not yet been tapped to serve as anything, let alone the highest health official in the land. Still, it struck a nerve. More and more, people seemed to clamor for things that were unproven, to question things that were and to express not only mistrust but outright hostility toward the doctors, scientists and civil servants trying to separate one from the other. That hostility was being nourished by exactly the kind of mis- and disinformation Kennedy was espousing. It was easy to paint the F.D.A. as a supervillain (an aggressive suppressor of sunlight, vitamins and exercise, to borrow Kennedy’s language), in part because the truth was so much more complex.

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Medical Societies Sue Kennedy and H.H.S. Over Vaccine Advice

Six leading medical organizations filed a lawsuit on Monday against Robert F. Kennedy Jr., the health secretary, and the federal Department of Health and Human Services, charging that recent decisions limiting access to vaccines were unscientific and harmful to the public.

The suit, filed in federal court in western Massachusetts, seeks to restore Covid vaccines to the list of recommended immunizations for healthy children and pregnant women.

Mr. Kennedy has been on a “decades-long mission” to undermine vaccines and to portray them as more dangerous than the illnesses they are designed to prevent, said Richard H. Hughes IV, a lawyer who teaches vaccine law at George Washington University and is leading the effort.

“The secretary’s intentions are clear,” Mr. Hughes said: “He aims to destroy vaccines.”

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Destroying 50 years of women’s health samples is like ‘burning the Library of Congress’

For decades, researchers have been collecting samples from hundreds of thousands of women and tracking their health. The work has deepened our basic understanding of human health, but now the entire project is in danger.

When nurses Patricia Chubb, 70, and her mother, Charlotte Mae Rohrbaugh, 98, joined the fledgling Harvard University-led Nurses’ Health Study in 1976, they had no idea it would last for nearly 50 years.

“It’s probably the longest, if not one of the longest, prospective health care studies for women that’s ever been done,” said Chubb, who lives in Pennsylvania. “They picked nurses to do the study because they know how to answer health questions correctly and can draw their own blood and the like — it’s very cost-effective.”

Study data gathered through the years from some 280,000 nurses in the United States has contributed enormously to improving how we live. The work has informed dietary recommendations, including national dietary guidelines led to hormonal therapies for breast cancer prevention and treatment; and contributed to research about how nutrients, inflammatory markers and heavy metals influence disease development.

Yet all of that priceless data may soon be discarded due to President Donald Trump’s ongoing feud with Harvard over what Trump claims is a failure to protect Jewish students during campus protests.

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We will not stay silent on vaccines, say leaders of five major U.S. medical associations

The authors are the presidents of American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American College of Obstetricians and Gynecologists, and the Infectious Diseases Society of America.

Let us introduce ourselves. We are the doctors you trust with your health and the health of your family across every stage of life, from the first checkups in infancy and childhood, to health care during pregnancy and adulthood, through management of chronic illness and aging. We are family physicians, pediatricians, internal medicine physicians, OB-GYNs, and infectious disease experts. Our commitment is not to politics, but to the absolute well-being of our patients and populations, and to providing them with best evidence-based health care.

We have an urgent, united message: Immunizations work, they are very effective and safe, and they save lives. Vaccines are among the most rigorously studied and effective tools in public health. Through widespread immunization, we have eradicated debilitating and fatal diseases that once caused serious illness, hospitalization, and death for millions of people.

But today, that legacy is at serious risk.

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Viewpoint: CDC’s upcoming vaccine advisory meeting set up to sow distrust in vaccines

This week’s meeting of the Advisory Committee on Immunization Practices (ACIP) is likely to mark its end—for now—as a vaccine advisory body.

Regardless of which party controlled the White House and who served as secretary of the Department of Health and Human Services (HHS), ACIP—a federal advisory committee of the US Centers for Disease Control and Prevention (CDC)—held meetings that included presentations of vetted, evidence-based data and used a structured framework for moving from scientific evidence to vaccine recommendations.

Based on what we have learned about the new committee members appointed by the secretary, the meeting agenda and presenters, however, the purpose of the meeting appears to be an opportunity to deemphasize vaccine benefits—many of which are largely invisible to the public and taken for granted—and emphasize the potential risks of vaccines.

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The U.S. is cutting billions from science. Canadian researchers say it’s time to step up

Scientists in Canada are scrambling. Over the past few months, the U.S. government has cut billions of dollars in funding from scientific research as part of sweeping cost-cutting measures.

“It’s really shocking. It’s really like this big cloud over science,” Kate Moran, CEO of Ocean Networks Canada, told Quirks & Quarks. Ocean Networks Canada participates in a project called the Argo system, an international program that collects information from on and under the ocean using a fleet of robotic instruments that drift with the ocean currents.

But that program, which is led by researchers in the U.S., could be at risk.

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‘I Think He Is About to Destroy Vaccines in This Country’

I think we are on the verge of losing vaccines for this country, from this country. And the reason is that Robert F. Kennedy Jr. will hold up a paper, in the next four or five months, that says it’s aluminum in vaccines that are causing a whole swath of problems, including autism. I think he is about to destroy vaccines in this country. I do.

— Paul Offit
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RFK Jr. names new members of CDC’s vaccine advisory panel

WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday unveiled the names of the eight new members who will sit on the panel of experts that advises the Centers for Disease Control and Prevention on vaccine policy, and said they would review the current vaccine schedule, as well as evaluate new shots.

The new members include several well-known critics of vaccines.

“The slate includes highly credentialed scientists, leading public-health experts, and some of America’s most accomplished physicians,” Kennedy wrote in a post on X.

The appointment comes just days after Kennedy dismissed every member of the committee, calling for a “clean slate” with new members. The committee is scheduled to hold a meeting later this month.

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Kennedy dismisses entire US CDC vaccine panel, replacing all 17 members

WASHINGTON, June 9 (Reuters) – Health Secretary Robert F. Kennedy Jr. has fired all members sitting on a U.S. Centers for Disease Control and Prevention panel of vaccine experts and is reconstituting the committee, his department said on Monday.

Kennedy removed all 17 members of the Advisory Committee on Immunization Practices, the Department of Health and Human Services said in a statement, and is in the process of considering new members to replace them.

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NIH scientists publish declaration criticizing Trump’s deep cuts in public health research

WASHINGTON (AP) — In his confirmation hearings to lead the National Institutes of Health, Jay Bhattacharya pledged his openness to views that might conflict with his own. “Dissent,” he said, ”is the very essence of science.”

That commitment is being put to the test.

On Monday, scores of scientists at the agency sent their Trump-appointed leader a letter titled the Bethesda Declaration, challenging “policies that undermine the NIH mission, waste public resources, and harm the health of Americans and people across the globe.”

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Exclusive: CDC expert resigns from COVID vaccines advisory role, sources say

Pediatric infectious disease expert Dr. Lakshmi Panagiotakopoulos of the U.S. CDC resigned on Tuesday as co-leader of a working group that advises outside experts on COVID-19 vaccines and is leaving the agency, two sources familiar with the move told Reuters.

Panagiotakopoulos said in an email to work group colleagues that her decision to step down was based on the belief she is “no longer able to help the most vulnerable members” of the U.S. population.

In her role at the Centers for Disease Control and Prevention’s working group of the Advisory Committee on Immunization Practices, she co-led the gathering of information on topics for presentation.

Her resignation comes one week after Health Secretary Robert F. Kennedy Jr., a long-time vaccine skeptic who oversees the CDC, the Food and Drug Administration and the National Institutes of Health, said the COVID vaccine for healthy children and healthy pregnant women had been removed from the CDC’s recommended immunization schedule.

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RFK Jr.’s stance on Covid vaccines for pregnant women is profoundly unethical

Health and Human Services Secretary Robert Kennedy’s proposal to end the government’s existing Covid vaccine recommendation for healthy pregnant women, if enacted, will be a major setback to decades’ worth of efforts to advance the health of pregnant people and their babies.

It also profoundly unethical.

Pregnant people are consistently left behind in biomedical R&D in ways that are deeply harmful to the health of both mother and child. In the decade before the Covid pandemic, consensus reports emerged denouncing this pregnancy evidence gap and providing road maps for how to ethically generate evidence during pregnancy within the confines of existing research regulations. I co-led one of these efforts, the PREVENT project, initiated in response to the Zika epidemic and completed in fall 2019. PREVENT specifically focused on how to ethically include pregnant women in the development and deployment of new vaccines for emerging pandemic threats.

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Cancelling funding for mRNA vaccine is both risky and foolish

With Donald Trump’s second administration, disruptive news seems to arise on a daily basis. Most concerning for clinicians and health scientists in Canada and around the world was Trump’s appointment of anti-vaccination zealot Robert Kennedy Jr. to the enormously influential position of Secretary of Health and Human Services. Kennedy’s ideological dismantling of the U.S.’s vaunted health research apparatus has been at speeds surprising even to his most ardent critics.

But his recent decision to cancel a nearly $600-million contract with vaccine manufacturer Moderna might be among his most shortsighted and destructive moves, with ripple effects globally.

The contract with the mRNA pioneer, signed under the Joe Biden administration, was meant to fund the development, testing and licensing of vaccines targeting particular flu strains, including the strain responsible for the dreaded avian flu, H5N1. Many scientists fear that H5N1 could become the next world-stopping infectious disease pandemic.

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‘Make America Healthy Again’ report updated to remove nonexistent studies

The White House downplayed questions about its flagship report on children’s health, but edited the document Thursday after authors listed in the paper confirmed it cited studies that do not exist.

The highly anticipated “Make America Healthy Again” (MAHA) report was released on May 22 by Health Secretary Robert F. Kennedy Jr. and the presidential commission tasked with assessing drivers of childhood chronic disease.

But authors and publishers of at least four studies listed in the original document told AFP they or their organizations were credited with papers they did not write — or that never existed.

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Loss Of MRNA, Bird Flu Vaccines Threatens Our Biosecurity

The Department of Health and Human Services announced Thursday that it’s canceling a $760 million contract with Moderna for a bird flu vaccine, saying that further development “was not scientifically or ethically justifiable.” The cancellation comes after Moderna received positive interim data from a trial testing the safety and immunogenicity of its H5N1 bird flu vaccine candidate. The fact that the Biden administration had approved the contract with Moderna did not help.

This administration’s distrust of mRNA vaccines has been apparent. In February, Rep. Adam Schiff stated that HHS Secretary Robert F. Kennedy Jr., “promoted the lie that mRNA vaccines alter human DNA.” Kennedy has previously called mRNA COVID-19 vaccinations dangerous. Further, at least seven states have proposed GOP-sponsored legislation banning or limiting mRNA vaccines and fueling mistrust in vaccines.

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Doctors fear ‘devastating consequences’ for pregnant people after RFK Jr order on Covid-19 boosters

Kennedy’s unilateral decision to change the CDC’s recommended immunization schedule for Covid-19 vaccines demonstrates once again why he is completely unqualified to be the HHS secretary.

In Congressional testimony on May 14, Kennedy said, ‘I don’t think people should be taking medical advice from me.’ Yet two weeks later he is making arbitrary public health decisions, defying norms, and with no accountability.

— Dr Robert Steinbrook, research director at consumer rights group Public Citizen
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RFK Jr says no COVID vaccines for healthy children, pregnant women

Today Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. made another sweeping change to the US vaccine landscape, saying the Centers for Disease Control and Prevention (CDC) has removed its recommendation of the COVID-19 vaccine for healthy children and pregnant women.

“I couldn’t be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant woman has been removed from the CDC recommended immunization schedule,” Kennedy said in a video message, flanked by Martin Makary, MD, MPH, commissioner of the Food and Drug Administration, and Jay Bhattacharya, MD, PhD, director of the National Institutes of Health.

The move comes just 1 week after the FDA announced—via an opinion piece in the New England Journal of Medicine—that the vaccine would now be offered only to adults 65 years and older or those with underlying conditions that made them vulnerable to severe COVID-19.

Today’s video message is short and direct but is already causing confusion, as pregnancy itself is considered a risk factor for severe COVID-19.

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The FDA’s misguided new Covid vaccine policy repeats past mistakes

The Food and Drug Administration is rewriting America’s Covid vaccine playbook — and not for the better. Its new guidance would trade the clarity and reach of our current vaccination strategy for a confusing age-based and risk-based framework that simply doesn’t fit the realities of Americans’ health. As a primary care physician who has spent years on the front lines of pandemic response, I see this as a step backward that ignores both the lessons of our past and the needs of our most vulnerable patients.

The FDA’s proposed framework eerily mirrors the segmentation we attempted in fall 2021 with Covid boosters. When boosters initially rolled out in September 2021, the FDA authorized them only for specific groups: adults 65 and older, those 18-64 with high-risk conditions, and those with occupational exposure risks.

The approach failed. As someone who had to explain these complex eligibility requirements to confused patients, I can attest to the chaos it created. This limited approach created tremendous confusion among health care providers and patients alike. Pharmacies and clinics struggled to verify eligibility, people misunderstood their risk category and, ultimately, many high-risk individuals who genuinely needed boosters never received them.

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