Reading view

There are new articles available, click to refresh the page.

Without evidence, RFK Jr.’s vaccine panel tosses hep B vaccine recommendation

By: Beth Mole

Federal vaccine advisors hand-selected by anti-vaccine Health Secretary Robert F. Kennedy Jr. have voted to eliminate a recommendation that all babies be vaccinated against hepatitis B on the day of birth. The decision was made with no evidence of harm from that dose and no evidence of any benefit from the delay.

Public health experts, medical experts, and even some members of the panel decried the vote, which studies and historical data indicate will lead to more infections in babies that, in turn, will lead to more cases of chronic liver disease, liver cancer, and premature death.

“I will just say we have heard ‘do no harm’ is a moral imperative. We are doing harm by changing this [recommendation],” Cody Meissner, a pediatrician and voting member of the Advisory Committee on Immunization Practices (ACIP), said as he voted against the change.

Read full article

Comments

© Getty | Tim Clayton

CDC vaccine panel realizes again it has no idea what it’s doing, delays big vote

By: Beth Mole

The panel of federal vaccine advisors hand-selected by anti-vaccine Health Secretary Robert F. Kennedy Jr. has once again punted on whether to strip recommendations for hepatitis B vaccinations for newborns—a move it tried to make in September before realizing it didn’t know what it was doing. The decision to delay the vote today came abruptly this afternoon when the panel realized it still does not understand the topic or what it was voting on.

Prior to today’s 6–3 vote to delay a decision, there was a swirl of confusion over the wording of what a new recommendation would be. Panel members had gotten three different versions of the proposed recommendation in the 72 hours prior to the meeting, one panelist said. And the meeting’s data presentations this morning offered no clarity on the subject—they were delivered entirely by anti-vaccine activists who have no subject matter expertise and who made a dizzying amount of false and absurd claims.

“Completely inappropriate”

Overall, the meeting was disorganized and farcical. Kennedy’s panel has abandoned the evidence-based framework for setting vaccine policy in favor of airing unvetted presentations with misrepresentations, conspiracy theories, and cherry-picked studies. At times, there were tense exchanges, chaos, confusion, and misunderstandings.

Read full article

Comments

© Getty | Elijah Nouvelage

12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid

By: Beth Mole

On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a scathing rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they framed as a “threat” to the FDA’s work and a danger to Americans’ health.

In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.

Read full article

Comments

© Getty | Joe Raedle

More FDA drama: Top drug regulator calls it quits after 3 weeks

By: Beth Mole

The top drug regulator at the Food and Drug Administration, Richard Pazdur, has decided to retire from the agency just three weeks after taking the leading position, according to multiple media outlets.

Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for an agency that has been mired in turmoil during the second Trump administration. He took over the role of leading the FDA’s Center for Drug Evaluation and Research on November 11, after the previous leader, George Tidmarsh, left the agency amid an investigation and a lawsuit regarding allegations that he used his position to exact petty revenge on a former business partner. In light of the scandal, one venture capital investor called the agency a “clown show.” Drug industry groups, meanwhile, called the FDA erratic and unpredictable.

Pazdur’s selection was seen as a positive sign by agency insiders, drug industry representatives, and patient advocacy groups, according to reporting by The Washington Post.

Read full article

Comments

© Getty | Congressional Quarterly

Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease

By: Beth Mole

When the federal vaccine committee hand-picked by anti-vaccine Health Secretary Robert F. Kennedy Jr. meets again this week, it will have yet another new chairperson to lead its ongoing work of dismantling the evidence-based vaccine recommendations set by the Centers for Disease Control and Prevention.

On Monday, the Department of Health and Human Services announced that the chairperson who has been in place since June—when Kennedy fired all 17 expert advisors on the committee and replaced them with questionably qualified allies—is moving to a senior role in the department. Biostatistician Martin Kulldorff will now be the chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS said. As such, he’s stepping down from the vaccine committee, the Advisory Committee on Immunization Practices (ACIP).

Kulldorff gained prominence amid the COVID-19 pandemic, criticizing public health responses to the crisis, particularly lockdowns and COVID-19 vaccines. He was a co-author of the Great Barrington Declaration that advocated for letting the deadly virus spread unchecked through the population, which was called unethical by health experts.

Read full article

Comments

© Getty | Elijah Nouvelage

Four-inch worm hatches in woman’s forehead, wriggles to her eyelid

By: Beth Mole

If you need some motivation to keep from eating too much this Thanksgiving, here it is: Doctors in Romania pulled an 11 cm (4.3 inch) living, writhing round worm from a woman’s left eyelid.

According to a report in the New England Journal of Medicine, the worm likely hatched from a hard lump in her right temple, which the woman recalled first spotting a month beforehand. She also noticed that the nodule had vanished just a day before the worm apparently made a squiggly run for her eye.

When she went to an ophthalmologist the next day, doctors immediately noted the “mobile lesion” on her eyelid, which was in the suspicious shape of a bunched-up worm just under her skin with a little redness and swelling.

Read full article

Comments

RFK Jr.’s new CDC deputy director prefers “natural immunity” over vaccines

By: Beth Mole

Under ardent anti-vaccine Health Secretary Robert F. Kennedy Jr., the Centers for Disease Control and Prevention has named Louisiana Surgeon General Ralph Abraham as its new principal deputy director—a choice that was immediately called “dangerous” and “irresponsible,” yet not as bad as it could have been, by experts.

Physician Jeremy Faust revealed the appointment in his newsletter Inside Medicine yesterday, which was subsequently confirmed by journalists. Faust noted that a CDC source told him, “I heard way worse names floated,” and although Abraham’s views are “probably pretty terrible,” he at least has had relevant experience running a public health system, unlike other current leaders of the agency.

But Abraham hasn’t exactly been running a health system the way most public health experts would recommend. Under Abraham’s leadership, the Louisiana health department waited months to inform residents about a deadly whooping cough (pertussis) outbreak. He also has a clear record of anti-vaccine views. Earlier this year, he told a Louisiana news outlet he doesn’t recommend COVID-19 vaccines because “I prefer natural immunity.” In February, he ordered the health department to stop promoting mass vaccinations, including flu shots, and barred staff from running seasonal vaccine campaigns.

Read full article

Comments

© Getty | Bill Clark/CQ Roll Call

There may not be a safe off-ramp for some taking GLP-1 drugs, study suggests

By: Beth Mole

The popularity of GLP-1 weight-loss medications continues to soar—and their uptake is helping to push down obesity rates on a national scale—but a safe, evidence-based way off the drugs isn’t yet in clear view.

An analysis published this week in JAMA Internal Medicine found that most participants in a clinical trial who were assigned to stop taking tirzepatide (Zepbound from Eli Lilly) not only regained significant amounts of the weight they had lost on the drug, but they also saw their cardiovascular and metabolic improvements slip away. Their blood pressure went back up, as did their cholesterol, hemoglobin A1c (used to assess glucose control levels), and fasting insulin.

In an accompanying editorial, two medical experts at the University of Pittsburgh, Elizabeth Oczypok and Timothy Anderson, suggest that this new class of drugs should be rebranded from “weight loss” drugs to “weight management” drugs, which people may need to take indefinitely.

Read full article

Comments

© Getty | helby Knowles

Why you don’t want to get tuberculosis on your penis

By: Beth Mole

A man in Ireland earned the unpleasant distinction of developing an exceedingly rare infection on his penis—one that has a puzzling origin, but may be connected to his work with dead animals.

According to an article published in ASM Case Reports on Thursday, the 57-year-old man went to a hospital in Dublin after his penis became red, swollen, and painful over the course of a week. He also had a fever. Doctors promptly admitted him to the hospital and noted that he had received a kidney transplant 15 years prior. As such, he was on immunosuppressive drugs, which keep his body from rejecting the organ, but could also allow infections to run amok.

Initial blood work found hints of an infection, and the doctors initially suspected a bacterial skin infection (cellulitis) had taken hold in his nether region. So, they put him on some standard antibiotics for that. But his penis only got worse, redder, and more swollen. This prompted consultation with infectious disease doctors.

Read full article

Comments

© Getty | NIH/NIAID

Infant botulism outbreak doubles; ByHeart confirms bacteria in formula

By: Beth Mole

ByHeart announced on Thursday that its own testing identified the bacterium that causes botulism in its baby formula, which is linked to an ongoing infant botulism outbreak that has doubled since last week.

As of November 19, there have been 31 cases across 15 states—up from 15 cases in 12 states reported last week. All 31 cases so far have been hospitalized. No deaths have been reported.

The outbreak was announced on November 8, and ByHeart was, at first, unusually aggressive in deflecting blame for linked illnesses.

Read full article

Comments

© ByHeart

RFK Jr.’s loathesome edits: CDC website now falsely links vaccines and autism

By: Beth Mole

With ardent anti-vaccine activist Robert F. Kennedy Jr. as the country’s top health official, a federal webpage that previously laid out the ample evidence refuting the misinformation that vaccines cause autism was abruptly replaced Wednesday with an anti-vaccine screed that promotes the false link.

It’s a move that is sure to be celebrated by Kennedy’s fringe anti-vaccine followers, but will only sow more distrust, fear, and confusion among the public, further erode the country’s crumbling vaccination rates, and ultimately lead to more disease, suffering, and deaths from vaccine-preventable infections, particularly among children and the most vulnerable.

On the Centers for Disease Control and Prevention’s website titled “Autism and Vaccines,” the previous top “key point” accurately reported that: “Studies have shown that there is no link between receiving vaccines and developing autism spectrum disorder (ASD).”

Read full article

Comments

© Getty | Win McNamee

CDC data confirms US is 2 months away from losing measles elimination status

By: Beth Mole

Federal health officials have linked two massive US measles outbreaks, confirming that the country is about two months away from losing its measles elimination status, according to a report by The New York Times.

The Times obtained a recording of a call during which officials from the Centers for Disease Control and Prevention confirmed to state health departments that the ongoing measles outbreak at the border of Arizona and Utah is a continuation of the explosive outbreak in West Texas that began in mid- to late-January. That is, the two massive outbreaks are being caused by the same subtype of measles virus.

This is a significant link that hasn’t previously been reported despite persistent questions from journalists and concerns from health experts, particularly in light of Canada losing its elimination status last week. The loss of an elimination status means that measles will once again be considered endemic to the US, an embarrassing public health backslide for a vaccine-preventable disease.

Read full article

Comments

© Getty | Jan Sonnenmair

Trump admin axed 383 active clinical trials, dumping over 74K participants

By: Beth Mole

When the Trump administration brutally cut federal funding for biomedical research earlier this year, at least 383 clinical trials that were already in progress were abruptly canceled, cutting off over 74,000 trial participants from their experimental treatments, monitoring, or follow-ups, according to a study published today in JAMA Internal Medicine.

The study, led by researchers at Harvard, fills a knowledge gap of how the Trump administration’s research funding cuts affected clinical trials specifically. It makes clear not just the wastefulness and inefficiency of the cuts but also the deep ethical violations, JAMA Internal Medicine editors wrote in an accompanying editor’s note.

In March, the National Institutes of Health, under the control of the Trump administration, announced that it would cancel $1.8 billion in grant funding that wasn’t aligned with the administration’s priorities. The Harvard researchers, led by health care policy expert Anupam Jena, used an NIH database and a federal accountability tracking tool to find grants supporting clinical trials that were active as of February 28 but had been terminated by August 15.

Read full article

Comments

© Getty | Francis Chung

Judge smacks down Texas AG’s request to immediately block Tylenol ads

By: Beth Mole

A Texas Judge has rejected a request from Texas Attorney General Ken Paxton to issue a temporary order barring Tylenol’s maker, Kenvue, from claiming amid litigation that the pain and fever medication is safe for pregnant women and children, according to court documents.

In records filed Friday, District Judge LeAnn Rafferty, in Panola County, also rejected Paxton’s unusual request to block Kenvue from distributing $400 million in dividends to shareholders later this month.

The denials are early losses for Paxton in a politically charged case that hinges on the unproven claim that Tylenol causes autism and other disorders—a claim first introduced by President Trump and his anti-vaccine health secretary, Robert F. Kennedy Jr.

Read full article

Comments

© Getty | RONALDO SCHEMIDT

As shutdown ends, dubious CDC panel gets back to dismantling vaccine schedule

By: Beth Mole

With the government reopening, the dubious panel of vaccine advisors selected by anti-vaccine Health Secretary Robert F. Kennedy is wasting no time getting back to dismantling the federal childhood vaccine schedule.

A meeting that was scheduled for October but put on hold during the shutdown has already been rescheduled for December 4 and 5. A Federal Register notice Thursday said that the meeting will “include discussions on vaccine safety, the childhood and adolescent immunization schedule, and hepatitis B vaccines.” The announcement was light on information beyond that but indicated that there would be a vote on hepatitis B vaccines.

The panel—the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention—is typically composed of preeminent, extensively vetted vaccine experts. But, in June, Kennedy summarily fired all 17 experts on the panel and installed 12 new members, almost all of whom are questionably qualified and espouse anti-vaccine views.

Read full article

Comments

© Getty | Elijah Nouvelage

This flu season looks grim as H3N2 emerges with mutations

By: Beth Mole

Health officials in the United Kingdom are warning that this year’s flu season for the Northern Hemisphere is looking like it will be particularly rough—and the US is not prepared.

The bleak outlook is driven by a new strain of H3N2, which emerged over the summer (at the end of the Southern Hemisphere’s season) sporting several mutations. Those changes are not enough to spark the direst of circumstances—a deadly pandemic—but they could help the virus dodge immune responses, resulting in an outsize number of severe illnesses that could put a significant strain on hospitals and clinics.

In the UK, the virus has taken off. The region’s flu season has started around five weeks earlier than normal and is making a swift ascent.

Read full article

Comments

© Getty | BSIP

❌