health

as-shutdown-ends,-dubious-cdc-panel-gets-back-to-dismantling-vaccine-schedule

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

Nevertheless, Kennedy’s ACIP members planned to push the first dose back a month. A vote was prepared to recommend not giving a birth dose unless there was “individual based decision-making.” While at first the panel seemed poised to vote in favor of the change, the plan collapsed with basic questioning.

Voting ACIP member Joseph Hibbeln, a psychiatrist, noted: “I’m unclear if we’ve been presented with any safety or data comparing before one month to after one month,” he said. They had not.

“And,” Hibbeln continued, “I’m wondering why one month was selected as our time point and if there are data to help to inform us if there’s greater risk of adverse effects before one month or after one month at all.”

There is no data suggesting that such a move would be more or less safe.

The discussion quickly spiraled from there with an eventual vote of 11-1 to table voting on the vaccine recommendation. According to the Federal Register notice, ACIP will try to take up the topic again. They could revive the vote or attack some other aspect of vaccine recommendations.

Pediatricians fight back

Health experts have blasted Kennedy’s lineup and their attacks on childhood vaccines, including the hepatitis B vaccination schedule. The current schedule “remains the best protection against serious health problems like liver disease and cancer,” the American Academy of Pediatrics emphasized to Ars.

With ACIP’s standing tarnished under Kennedy, AAP has put forth its own evidence-based vaccine schedule for pediatricians to trust. They’ve also been a prominent opponent among medical organizations to Kennedy’s efforts. For instance, in a revised federal lawsuit, the AAP along with other medical organizations is seeking to overturn all decisions made by Kennedy’s ACIP and replace the entire panel with actual experts.

Kennedy’s appointees “lack the credentials and experience required of their role,” and all their votes should be declared “null and void,” the organization said.

AAP President Susan Kressly said that pediatricians are already seeing the effects of having an anti-vaccine activist as the US health secretary, namely “fear, decreased vaccine confidence, and barriers for families to access vaccines.”

“The nation’s children are already paying the price in avoidable illnesses and hospitalizations,” Kressly said. “We urge federal leaders to restore the science-based deliberative process that has made the United States a global leader in public health. Urgent action is needed.”

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

this-flu-season-looks-grim-as-h3n2-emerges-with-mutations

This flu season looks grim as H3N2 emerges with mutations

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 outsized 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.

The UK’s flu season progress. Credit: UKHSA

Jim Mackey, who became chief executive of NHS England in April, is bracing for influenza’s wrath. “There’s no doubt this winter will be one of the toughest our staff have ever faced,” Mackey told The BMJ. “Since stepping into this role, the thought of a long, drawn-out flu season has kept me awake at night. And, unfortunately, it looks like that fear is becoming reality.”

Almost all of the UK cases so far this year have been from influenza A strains, with H3N2 accounting for the lion’s share, according to the UK Health Security Agency. The two circulating influenza A strains are the new H3N2 strain and an H1N1 strain, with an influenza B strain circulating at very low rates. In the latest UK data, H3N2 was behind over 90 percent of cases that had their influenza virus type analyzed.

“Of the two seasonal influenza A viruses, the current dominant circulating virus (A/H3N2) tends to cause more severe illness than A/H1N1, particularly in older adults,” Antonia Ho, an infectious diseases expert at the University of Glasgow, said in a statement. And the early start of the flu season only makes things worse, since not as many people are vaccinated early on, Ho added. “From previous experience, influenza waves that start early tend to affect a larger number of people in the population.”

This flu season looks grim as H3N2 emerges with mutations Read More »

canada-fought-measles-and-measles-won;-virus-now-endemic-after-1998-elimination

Canada fought measles and measles won; virus now endemic after 1998 elimination

“This loss represents a setback, of course, but it is also reversible,” Jarbas Barbosa, director of PAHO, said in a press briefing Monday.

Call to action

Barbosa was optimistic that Canada could regain its elimination status. He highlighted that such setbacks have happened before. “In 2018 and 2019, Venezuela and Brazil temporarily lost their elimination status following large outbreaks,” Barbosa noted. “Thanks to coordinated action by governments, civil society, and regional cooperation, those outbreaks were contained, and the Region of the Americas regained its measles-free status in 2024.”

On Monday, the Public Health Agency of Canada released a statement confirming that it received notification from PAHO that it had lost its measles elimination status, while reporting that it is already getting to work on earning it back. “PHAC is collaborating with the PAHO and working with federal, provincial, territorial, and community partners to implement coordinated actions—focused on improving vaccination coverage, strengthening data sharing, enabling better overall surveillance efforts, and providing evidence-based guidance,” the agency said.

However, Canada isn’t the only country facing an uphill battle against measles—the most infectious virus known to humankind. Outbreaks and sustained spread are also active in the US and Mexico. To date, the US has documented at least 1,618 measles cases since the start of the year, while Mexico has tallied at least 5,185. Bolivia, Brazil, Paraguay, and Belize also have ongoing outbreaks, PAHO reported.

As of November 7, PAHO has collected reports of 12,593 confirmed measles cases from 10 countries, but approximately 95 percent of them are in Canada, Mexico, and the US. That total is a 30-fold increase compared to 2024, PAHO notes, and the rise has led to at least 28 deaths: 23 in Mexico, three in the United States, and two in Canada.

The PAHO used Canada’s loss as a call to action not just in the northern country, but the rest of the region. “Every case we prevent, every outbreak we stop saves lives, protects families, and makes communities healthier,” Barbosa said. “Today, rather than lamenting the loss of a regional status, we call on all countries to redouble their efforts to strengthen vaccination rates, surveillance, and timely response to suspected cases—reaching every corner of the Americas. As a Region, we have eliminated measles twice. We can do it a third time.”

Canada fought measles and measles won; virus now endemic after 1998 elimination Read More »

james-watson,-who-helped-unravel-dna’s-double-helix,-has-died

James Watson, who helped unravel DNA’s double-helix, has died

James Dewey Watson, who helped reveal DNA’s double-helix structure, kicked off the Human Genome Project, and became infamous for his racist, sexist, and otherwise offensive statements, has died. He was 97.

His death was confirmed to The New York Times by his son Duncan, who said Watson died on Thursday in a hospice in East Northport, New York, on Long Island. He had previously been hospitalized with an infection. Cold Spring Harbor Laboratory also confirmed his passing.

Watson was born in Chicago in 1928 and attained scientific fame in 1953 at 25 years old for solving the molecular structure of DNA—the genetic blueprints for life—with his colleague Francis Crick at England’s Cavendish laboratory. Their discovery heavily relied on the work of chemist and crystallographer Rosalind Franklin at King’s College in London, whose X-ray images of DNA provided critical clues to the molecule’s twisted-ladderlike architecture. One image in particular from Franklin’s lab, Photo 51, made Watson and Crick’s discovery possible. But, she was not fully credited for her contribution. The image was given to Watson and Crick without Franklin’s knowledge or consent by Maurice Wilkins, a biophysicist and colleague of Franklin.

Watson, Crick, and Wilkins were awarded the Nobel Prize in Physiology or Medicine in 1962 for the discovery of DNA’s structure. By that time, Franklin had died (she died in 1958 at the age of 37 from ovarian cancer), and Nobels are not given posthumously. But Watson and Crick’s treatment of Franklin and her research has generated lasting scorn within the scientific community. Throughout his career and in his memoir, Watson disparaged Franklin’s intelligence and appearance.

James Watson, who helped unravel DNA’s double-helix, has died Read More »

questions-swirl-after-trump’s-glp-1-pricing-deal-announcement

Questions swirl after Trump’s GLP-1 pricing deal announcement

While some may stand to gain access to the drugs under these categories, another factor in assessing the deal’s impact is that millions are expected to lose federal health coverage under the Trump administration’s “One Big Beautiful Bill Act.”

Unmatched prices

In addition to the deals for federal programs, the administration also announced new direct-to-consumer prices. Currently, people with a prescription can buy the most popular drugs, Wegovy and Zepbound, directly from Novo Nordisk and Eli Lilly, respectively, for $499 each. Under the new deal, Wegovy will be available for $350, as will Ozempic. And Zepbound will be available at “an average” of $346. While the prices are lower, the out-of-pocket costs are still likely to be more than most people would pay if they went through an insurance plan, and paying outside their insurance policies means that the payments won’t be counted toward out-of-pocket maximums and other tallies. Generally, experts expect that direct-to-consumer sales won’t play a significant role in lowering overall drug costs.

It remains unclear if Trump’s deal will have any effect on GLP-1 prices for those on commercial insurance plans.

Trump hailed the deals, calling them “most favored-nation pricing.” But even with the lower prices for some, Americans are still paying more than foreign counterparts. As Sen. Bernie Sanders (I-Vt.) noted last year, while Novo Nordisk set Ozempic’s list price at nearly $1,000 in the US and the new deal is as low as $245, the drug costs just $155 in Canada, $122 in Italy, $71 in France, and $59 in Germany. Wegovy, similarly, is $186 in Denmark, $137 in Germany, and $92 in the United Kingdom. Eli Lilly’s Mounjaro is $94 in Japan.

A study published last year in JAMA Network Open led by researchers at Yale University estimated that the manufacturing cost for this class of drugs is under $5 for a month’s supply.

The announcement also said that future GLP-1 drugs in pill form (rather than injections) from the two companies will be priced at $150. That price will be for federal programs and direct-to-consumer sales. While such pills are nearing the market, none are currently available or approved by the Food and Drug Administration. Given that they are not yet for sale, the cost savings from this deal are unknown.

Questions swirl after Trump’s GLP-1 pricing deal announcement Read More »

“it’s-only-a-matter-of-time-before-people-die”:-trump-cuts-hit-food-inspections

“It’s only a matter of time before people die”: Trump cuts hit food inspections


American inspections of foreign food facilities hit historic lows this year.

Credit: Biswa1992/iStock via Getty Images

American inspections of foreign food facilities—which produce everything from crawfish to cookies for the US market—have plummeted to historic lows this year, a ProPublica analysis of federal data shows, even as inspections reveal alarming conditions at some manufacturers.

About two dozen current and former Food and Drug Administration officials blame the pullback on deep staffing cuts under the Trump administration. The stark reduction marks a dramatic shift in oversight at a time when the United States has never been more dependent on foreign food, which accounts for the vast majority of the nation’s seafood and more than half its fresh fruit.

The stakes are high: Foreign products have been increasingly linked to outbreaks of foodborne illness. In recent years, FDA investigators have uncovered disturbing lapses in facilities producing food bound for American supermarkets. In Indonesia, cookie factory workers hauled dough in soiled buckets. In China, seafood processors slid crawfish along cracked, stained conveyor belts. Investigators have reported crawling insects, dripping pipes, and fake testing data purporting to show food products were pathogen free.

In 2011, Congress—concerned about the different standards of overseas food operations—gave the FDA new authority to hold foreign food producers to the same safety standards as domestic ones. Although the agency’s small team remained unable to visit every overseas facility, inspections rose sharply after the mandate—sometimes doubling or tripling previous rates.

Now, the US is on track to have the fewest inspections on record since 2011, except during the global pandemic.

Inspections began to decline early in the administration, after 65 percent of the staff in the FDA divisions responsible for coordinating travel and budgets left or were fired in the name of government efficiency.

Investigators suddenly had to book their own flights and hotels, obtain diplomatic passports and visas, and coordinate with foreign authorities, former and current FDA staffers told ProPublica. After workers tasked with processing expenses were laid off, investigators waited as a backlog of unfulfilled reimbursements climbed to more than $1 million, a former staffer said. (Investigators are responsible for paying off their own credit cards.) Senior investigators close to retirement also took the opportunity to get out.

Played out on a large scale, this combination of firings and voluntary departures has left the agency scrambling to make up for the loss of 1 out of every 5 of its workers responsible for ensuring the safety of America’s food and drugs.

Susan Mayne, the former director of the FDA’s Center for Food Safety and Applied Nutrition and an adjunct professor at Yale School of Public Health, expressed alarm at the drop in foreign inspections.

“It’s very concerning that we are seeing these kinds of reductions,” said Mayne, who emphasized the administration’s cuts have hamstrung an agency that has long struggled to retain investigators who conduct both foreign and domestic inspections. In an attempt to maintain its numbers, the agency had been working on initiatives to elevate pay and adopt specialized training for investigators. “The plans that were in place to address staffing have now been undermined.”

The gutting of the workforce coincides with other actions the administration has taken that are poking holes in the nation’s food safety net. In March, the FDA announced it was delaying compliance with a rule to speed up the identification and removal of harmful products in the food system, to give more time for companies to follow the rules. The next month, it suspended a quality control program that ensured consistency and accuracy across its 170 pathogen and contaminant labs as a result of staffing cuts.

Then in July, the administration quietly scaled back the Foodborne Diseases Active Surveillance Network, also known as FoodNet, shrinking its surveillance to just two pathogens: salmonella and a common type of E. coli. The program—a partnership between the FDA, the Centers for Disease Control and Prevention, the Department of Agriculture, and state health departments—was responsible for the critical monitoring of eight foodborne illnesses, including infections caused by the deadly bacteria Listeria. In response to the change, a CDC spokesperson previously claimed that the program’s surveillance had been duplicative.

The administration did not respond to ProPublica’s questions about these actions.

“There are going to be things that fall through the cracks, and these things aren’t negligible,” said a current FDA investigations official who spoke on the condition of anonymity, fearing reprisal. The same was true of other current and former agency staffers; those who still had jobs risked losing them, while former employees worried about their chances of being rehired or the security of their severance or retirement packages.

The Department of Health and Human Services refused to respond to any of ProPublica’s questions about the decrease in foreign food inspections, citing the government shutdown. “Responding to ProPublica is not considered a mission-critical activity,” said Emily Hilliard, the department’s press secretary. The FDA and the White House also did not respond to requests for comment.

“Basic regulatory oversight functions have been decimated,” said Brian Ronholm, the director of food policy at Consumer Reports. “There’s an enhanced risk of more outbreaks.”

An agency already struggling

The FDA has long been one of the main protectors of the American food supply. The federal agency oversees about 80 percent of what people eat, including fruits, vegetables, processed goods, dairy products and infant formula, and most seafood and eggs. It regulates more than 220,000 farms, food plants, and distributors, inspecting facilities, testing for pathogens, tracing outbreaks, and issuing recalls.

Only 40 percent of the facilities that the FDA regulates are within the nation’s borders. While the agency examines some products at ports of entry, those reviews are often cursory; workers cannot manually inspect every import or uncover whether a foreign plant properly cleans its equipment, conducts adequate salmonella testing, or has a rat infestation. In-person facility inspections are necessary for that kind of insight.

For example, in 2023, an FDA investigator inspected a Chinese manufacturer of soy protein powder, a common additive in shakes and other beverages. While the company had previously imported its products into the United States without scrutiny, the investigator’s thorough visit found numerous violations, according to an agency report obtained through a federal records request.

Live insects crawled through the facility’s production workshop, while dead ones lay on the floor. Condensation from rust-covered pipes dripped into a water tank waiting to be mixed with raw ingredients. Just outside the plant, the investigator found processing waste and stagnant water coated with a green biofilm, attracting a swarm of bugs too numerous to count.

When the investigator reviewed the firm’s bacteria testing records, which purportedly verified the products were free of salmonella and E. coli, he discovered the company was providing fake data to “satisfy the customer specifications,” according to his inspection report.

Company officials also tried to obstruct his inspection, blocking him from entering a packaging room when he tried to photograph the pest infestation. After the three-day review, the federal agent censured the company, Pingdingshan Tianjing Plant Albumen Co. Ltd., which promised to take corrective actions. The company did not respond to ProPublica’s emailed questions.

If investigators find a foreign food facility is unable to comply with American safety requirements or refuses to permit the FDA to inspect its establishment, the agency can block its products from entering the country.

These crucial foreign inspections are neither easy nor cheap. They typically last longer than domestic ones and cost nearly $40,000 a visit, and they can require months of logistical planning, special visas, and diplomatic approval from the host country.

In part because of these challenges, there was a time when the FDA conducted only a few hundred foreign inspections annually.

Then Congress passed the Food Safety Modernization Act of 2011, which set firm targets for the agency: It needed to conduct more than 19,000 foreign food inspections annually by 2016 and increase the number of food field staff to no fewer than 5,000 workers.

The FDA has never fulfilled this congressional mandate. Even before the second Trump administration, the agency was inspecting less than 10 percent of its target each year.

Dr. Stephen Ostroff, a former acting commissioner of the FDA who also served as the deputy commissioner for foods and veterinary medicine, said that the agency’s foreign food inspections have long been hindered by a lack of resources.

“It’s not because the agency isn’t interested in doing more overseas inspections—they are,” said Ostroff, who retired from the agency in 2019. “They simply don’t have the resources to be able to meaningfully do large numbers of overseas inspections.”

One major obstacle has been a lack of financial support. “Congressional appropriators have never provided the funding that FDA has determined it would need to do those foreign inspections,” said Mayne, who retired from the agency in 2023. Before the food safety act passed, the Congressional Budget Office estimated that the agency would need about $1.4 billion over five years to comply with the new requirements, which included the expansion of field staff and foreign inspections. But lawmakers approved only a fraction of that amount.

As of last year, the agency had about 430 employees conducting both foreign and domestic food inspections, with only 20 investigators dedicated solely to international assignments.

With such limitations, the agency’s inspections have often been reactive instead of proactive. In 2023, for example, FDA investigators did not descend on a Mexican strawberry farm until about 20 people had been hospitalized with hepatitis A, a highly contagious infection that causes liver inflammation and, in some cases, liver failure and death.

Hepatitis A is spread through the consumption of small or even microscopic bits of feces. Farm workers can shed the virus when picking fruit, or it can be transmitted through contaminated water.

At the Mexican berry farm, federal investigators found significant safety violations, including sanitation facilities with hand-washing water that was dirty, gray, and leaking throughout the growing area; one toilet offered no ability to wash one’s hands. The FDA censured the company, citing 11 violations of American food safety regulations. According to public data, the agency did not reinspect the farm to ensure it had made corrections even as its products kept entering the United States.

In January, less than two weeks before the second Trump administration came in, a report by the Government Accountability Office rebuked the FDA for consistently falling short of its foreign food inspection targets. The oversight office, recognizing the vital importance of the FDA’s food safety mission, urged Congress to direct the agency to assess how many foreign inspections are needed to keep the country’s food supply safe.

The FDA said in response that, in 2025, it would increase staffing levels and prioritize the training and development of investigators.

Then Donald Trump was inaugurated.

Reversing a decade of gains

During the first few weeks of the new Trump administration, foreign inspections carried on as usual. But the sudden hemorrhaging of FDA workers through firings, retirements, and buyouts quickly foiled the agency’s plans to ramp up staff and inspections.

While the administration had vowed that food safety inspectors would be spared, it began to cut critical investigative support staff in March, a move that would eventually incapacitate foreign inspections, current and former FDA staffers told ProPublica.

As the agency lost support staff, their responsibilities shifted to investigators, who were quickly overwhelmed by the new burdens. Passports, visas, and travel were all delayed.

“Support staff are not just there to bide time—they have a meaningful role,” said Sandra Eskin, who served as a top USDA food safety official in the Biden administration and is now the CEO of advocacy group Stop Foodborne Illness. “It’s like a game of Jenga: If you pull out one from the middle or the bottom, the whole tower collapses.”

In recent years, the agency has typically been able to conduct about 110 foreign food inspections each month, but in March, the number of inspections dropped almost in half compared with the monthly average in the previous two years.

As specialists who handled reimbursements were also fired, some investigators waited months for repayment, which made them reluctant to take on other foreign assignments, former and current staffers said.

The cuts and growing work burden quickly collapsed morale across the investigative division, leading many senior investigative officials with decades of experience to retire.

“We already had a significant percentage of our workforce that was eligible for retirement,” said a current FDA employee in the investigations division, “so reading the writing on the wall, they decided to exit.” These departures also interrupted the development of new investigators, as some of the senior staff members who left had been tasked with training new hires, a process that can take up to two years.

“There’s been such a brain drain,” said food safety expert Jennifer McEntire, founder of consulting firm Food Safety Strategy, “when inspectors do go out and are observing things, there’s no phone-a-friend.”

Instead of addressing the shortfall, in May, FDA Commissioner Dr. Marty Makary announced that the agency would expand the number of unannounced foreign inspections, in which investigators show up at facilities without alerting them first. Given the limited staff and resources, several current and former staffers told ProPublica that the prospect of conducting unannounced visits was impractical and even “comical.”

“A foreign unannounced trip is like an accelerated coordination process,” said a current FDA investigations official. “If you’re going to increase the number and not increase the staff, we don’t know how to make some of that stuff work.”

By the end of July, the number of foreign food inspections conducted by the agency was nearly 30 percent lower compared with similar periods in the previous two years. The administration refused to provide ProPublica with up-to-date inspection numbers, so we relied on data from the FDA’s public inspection dashboard to conduct this analysis.

Foreign inspections are not the only tool for overseeing food from abroad. The agency has developed partnerships with counterparts in other countries to ensure comparable oversight and required importers to verify that their foreign suppliers are following American standards. However, former and current agency staffers said that these initiatives also have been impacted by the administration’s cuts and recent departures.

While the administration’s cuts were ostensibly ordered to maximize efficiency and productivity, they have had an opposite effect, several former and current FDA employees said, reversing years of progress.

“The goal is to accomplish as much and more with less resources,” said a former high-level FDA investigations official. “Less inspections translate to less regulatory oversight, and that, from a public health perspective, never benefits the public.”

Scott Faber, senior vice president for government affairs at the nonprofit advocacy organization Environmental Working Group, said the fallout is simple:

“When you take a wrecking ball to the federal government, you are going to wind up undermining important government functions that keep all of us safe, especially our food,” he said. “It’s only a matter of time before people die.”

How we calculated foreign food inspections

To understand how inspections of foreign food facilities have changed, we used a publicly available dashboard where the FDA publishes the results of those inspections. This database also includes inspections for manufacturers of drugs, medical devices, cosmetics, tobacco, biologics, and veterinary products.

Beginning in May, we downloaded the entire database weekly and tracked the number of newly added foreign food facility inspections.

The dashboard is continually updated, with data added after inspections are finalized. That typically occurs 45 to 90 days after the close of an inspection, though some reports may not be posted until the agency takes a final enforcement action. Through an analysis, we determined that few reports are added more than 90 days after an inspection date.

Our story therefore only includes inspections through July. In an accompanying chart, we show the more provisional data through September. We asked HHS for recent figures, but the department refused to share them.

We considered the possibility that the downtrend in foreign food inspections was solely due to a lag in inspections being added to the dashboard. To check this, we performed the same analysis on domestic inspections. This analysis showed that while the rate of foreign inspections had significantly decreased, domestic inspections have continued almost uninterrupted.

This story originally appeared on ProPublica.

Photo of ProPublica

“It’s only a matter of time before people die”: Trump cuts hit food inspections Read More »

83-year-old-man-married-50-years-nearly-stumps-doctors-with-surprise-sti

83-year-old man married 50 years nearly stumps doctors with surprise STI

In the end, his combination of rash, malaise, liver and kidney problems, facial paralysis, and swelling all fit with syphilis. However, syphilis that affects the liver is rare, occurring in less than 10 percent of cases, which made the diagnosis particularly difficult.

Doctors think the infection was likely in the second stage. In the first stage, people just develop a chancre at the site of the infection. The chancre develops usually around a month after an exposure, is painless, and resolves on its own. Then the second stage emerges with the bacterial infection going systemic, usually with rash, malaise, loss of appetite, joint pain, swelling, fevers, and sore throat—similar to the man’s symptoms. After that, the infection can become latent (third stage) before reemerging in the tertiary (late stage), which can manifest in various ways, including with the destruction of the heart, central nervous system, and organs.

While late-stage syphilis can show up years or even decades after an initial infection, the secondary stage doesn’t, the doctors note. “Secondary syphilis typically emerges within the first year after untreated primary infection and only rarely beyond 4 years,” they wrote in the report. It’s possible an immunosuppressing drug, like the steroid he took for his facial paralysis, could reactivate a latent infection, but once reactivated, it would be a late-stage infection, not a secondary one.

Although the man’s STI history decades ago led the doctors to the right diagnosis, it doesn’t explain the current infection. A “more recent, unreported exposure must be considered,” the doctors wrote, but, ultimately, the timing and source of the infection remain unknown.

With a treatment of antibiotics, the man made a full recovery. His doctors note that local health authorities would be contacted to track down and notify the man’s actual sexual partners. How things went with the man’s wife also remains unknown.

83-year-old man married 50 years nearly stumps doctors with surprise STI Read More »

fda-described-as-a-“clown-show”-amid-latest-scandal;-top-drug-regulator-is-out

FDA described as a “clown show” amid latest scandal; top drug regulator is out

In September, Tidmarsh went after Tang’s Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide “hard” clinical benefit and that the drugmaker had not performed necessary trials.

Such a post from the FDA’s top drugmaker turned heads. Aurinia claims its share price fell 20 percent in a matter of hours, dropping $350 million in market value.

“Embarrassing”

Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process—not an abbreviated one—and been assessed based on a validated surrogate endpoint that is known to predict clinical outcomes. Further, the drug has been approved for use in 36 other countries in addition to the US.

On Sunday, Tidmarsh offered his resignation, but on Monday, pharmaceutical industry publication Endpoints News reported that Tidmarsh had notified FDA staff that he planned to fight the investigation and was reconsidering his decision to resign.

If the allegations in Aurinia’s lawsuit are true, Tidmarsh’s behavior would be egregious for a federal regulator. But already, the claims and other scandals have outsiders concerned that the high-stakes “soap opera” is destroying the agency’s credibility, as Stat reported Tuesday.

“We are witnessing nothing less than a clown show at FDA right now,” one venture capital investor told the outlet. “For the sake of patients, we need a stable and consistent FDA!”

“What’s happening at the top of the FDA is embarrassing,” a portfolio manager at a large biotech fund added. “How am I supposed to convince people, other investors, that this sector is doing important work when the leaders of the FDA are acting this way?”

FDA described as a “clown show” amid latest scandal; top drug regulator is out Read More »

inside-the-marketplace-for-vaccine-medical-exemptions

Inside the marketplace for vaccine medical exemptions


Not everything was quite as it seemed

Frontline Health Advocates provides medical exemption notes—for a fee. What exactly are they selling?

Maybe a client hears about them in the comment section of the Facebook group “Medical Exemption Accepted,” or on the r/unvaccinated forum on Reddit. Maybe it’s through an interview posted on the video-sharing platform Rumble. Or maybe it’s the targeted advertisements on Google: “We do medical exemptions.”

Cassandra Clerkin, a mother in upstate New York, first got in touch with Frontline Health Advocates near the start of the 2024–2025 school year, after hearing they had doctors who would write exemptions from school immunization requirements. One of Clerkin’s children, she said, had suffered seizures after receiving a vaccine. The family didn’t want more shots. But New York has some of the country’s strictest school immunization policies.

Perhaps Frontline could help.

Vaccine mandates have a long history in the United States, but they’ve been subject to fresh public attention—and partisan dispute—since the start of the Covid-19 pandemic. Frontline Health Advocates seemingly emerged from pandemic-era battles with a model that, experts say, appears to be unique: It bills itself as a standalone organization that supplies people across the US with medical exemptions from vaccination requirements—for a fee of $495.

On forms obtained by Undark, Frontline’s listed addresses are a storage facility in Denison, Texas, and a package store in Sedona, Arizona. The group publishes little information online about its leadership or finances, but it has quietly developed a following.

There’s little question that Frontline exemptions sometimes work, and some parents report positive experiences with the organization. But there are real questions about whether its legal strategy would hold up in court—and whether clients are confused about what, precisely, they are receiving.

In upstate New York, Clerkin said she spoke with a representative from Frontline by phone about the process. They made it sound, she said, like getting an exemption “would be pretty seamless.”

Soon after, she recalled, she received a call from a doctor named Andrew Zywiec. A week after the family issued a credit card payment of $495 to a chiropractic firm in California, the medical exemption arrived by email. “The duration of the restriction from receiving VACCINATIONS is PERMANENT,” the document stated, citing a range of health concerns, and warning that civil or criminal penalties could result if the school district ignored the request.

Clerkin submitted the document to the district.

Every state in the country has legal language on the books that seems to require certain immunizations before children can enroll in school—although in some places exemption policies are so lax that shots are effectively optional. The military also has vaccine requirements, as do some civilian workplaces, including many hospitals and nursing homes. Immigration proceedings, too, often require applicants to receive shots.

Some people may register personal objections to vaccination, or they may have medical conditions that could make receiving a shot dangerous. Workarounds exist. Most states, for example, allow parents to apply for religious or personal belief exemptions from school vaccine requirements by stating that they object to vaccination due to deeply held convictions. But those exemptions are sometimes denied, and in four states—California, Connecticut, Maine, and New York—they aren’t an option at all. (The policy in a fifth state, West Virginia, is currently in flux.)

In those states, the only way to attend school without a required shot is to receive a medical waiver. There are real reasons for some people to pursue them: They may be immunocompromised in a way that makes certain vaccines high-risk, or they may have had a bad reaction to a shot in the past. In some cases, families may earnestly believe their child cannot safely receive a vaccine, but have difficulty finding a physician who agrees, or who is willing to attest to that on an exemption.

Interest in medical exemptions tends to grow when laws tighten. In 2015, after a measles outbreak at Disneyland sickened hundreds of people, California lawmakers ended the state’s personal belief exemption. Almost immediately, the medical exemption rate more than doubled, according to a 2019 paper by a team of public health researchers. The law “created a black market for medical exemptions,” one unnamed health officer told the researchers. Parents, the officer added, would go online and “get medical exemptions from physicians who were not their child’s treating physician.”

The state cracked down, prosecuting some health care providers for allegedly providing improper medical exemptions, and tightening the rules for receiving a waiver. New York, which eliminated religious exemptions in 2019, has taken similar steps; the Department of Health maintains a public list of health care providers who have been banned or suspended from using immunization registries in the state, on a webpage titled “School Vaccination Fraud Awareness.”

In New York, advocates say, state policies have made it prohibitively difficult for some families to obtain medical exemptions, regardless of the reason. “My understanding is that up until this year, again, a lot of doctors weren’t willing to write these medical exemptions,” said Chad Davenport, an attorney outside Buffalo, New York, who often represents families seeking medical exemptions. (One of his clients recently won a key ruling in a federal court case against a Long Island school district that had denied medical exemptions from at least six health care providers.)

Enter Frontline Health Advocates. The organization, Davenport said, “kind of stepped in and provided families at least an option, or a potential path.”

Two researchers who have studied vaccination exemptions in the United States said the organization appears to have a unique model: While individual doctors have sometimes gained a reputation for supplying medical exemptions, neither expert had seen a full-fledged national organization offering those services.

“They’re very blatant,” said Dorit Reiss, a professor at UC Law San Francisco who studies vaccine law and policy.

The group’s founder and director is William Lionberger, a chiropractor who has been licensed to practice in California since 1981, and who once maintained a practice north of San Diego. According to public records, he has also served as a police officer in a town near Sedona. (Lionberger declined a request for an on-the-record interview, and the organization did not answer a list of questions from Undark.) Interviewers who have hosted Lionberger on their shows describe him as affiliated with America’s Frontline Doctors, a group that opposed Covid-19 vaccines and other public health measures while promoting unproven treatments like hydroxychloroquine.

Frontline Health Advocates’ webpage was first registered in March 2022, with a name echoing that of America’s Frontline Doctors. By April of that year, the website was inviting visitors to “Get your exemption now.” In a 2023 interview, Lionberger described having a “team of medical experts” who “work with all kinds of situations,” evaluating clients both for “regular vax injuries and regular vax exemptive conditions.”

He added: “People now don’t even want their kids to get anywhere near a regular vaccine.”

The group employs a pair of distinctive legal strategies. One of these is to form itself as something called a Private Ministerial Association. Online, some groups that help set up such private associations describe them as offering special First Amendment protections. A membership application document hosted on Frontline’s website describes the group as “a private, unincorporated ministry that operates as much as possible, outside the jurisdiction of government entities, agencies, officers, agents, contractors, and other representatives, as protected by law.”

Another strategy is to invoke federal disability law. In the 2023 interview, Lionberger boasted that they drew on “the most powerful thing that you can bring against discrimination”—specifically, federal protections. A promotional video posted on the Frontline website makes a similar claim, advertising waivers “supported by the protections under US federal laws.” Undark obtained three near-identical exemptions sent to New York families in 2024. In them, Frontline argues that the client’s need for a medical exemption is protected under the Americans with Disabilities Act, or ADA, which guarantees certain accommodations for people with disabilities and other medical needs.

In Frontline documents from 2024, the organization suggests that this federal protection supersedes state vaccination laws—offering a way around exemption policies across the country.

In New York, Clerkin had received a document combining medical language with legal details. The document bore the signatures of doctor Andrew Zywiec and an administrative law specialist and JD, Christine Pazzula, along with the seal of the United States Department of Justice.

Not everything was quite as it seemed. Frontline has no relationship with the Department of Justice. Pazzula, according to her LinkedIn profile, had received her legal degree from an unaccredited correspondence school in California, and her name does not appear in databases of attorneys admitted to the bar in New York, Texas, or Nevada, where her LinkedIn profile says she is based. (In a brief email to Undark, Pazzula said she no longer works for Frontline.)

Another parent who received a Frontline exemption in 2024 would later testify under oath that she believed Zywiec to be a physician licensed in the state of New York, but state records show that nobody named Zywiec has ever held a medical license in the state.

Multiple online testimonials about Frontline mention Zywiec. A review of public records suggests a turbulent history. Zywiec served in the Army and graduated from medical school in 2019, according to a CV. In 2020, he began a pediatrics residency at The Brooklyn Hospital Center, but the relationship soured: He ultimately sued the hospital, alleging an unsafe work environment, and filed an employment complaint that, among other concerns, said he had been “coerced into taking the so-called Covid-19 vaccine.” In court documents associated with the lawsuit, a hospital official described an employee who was “spotty and difficult.” In 2021, Zywiec’s co-residents had written a letter to their superiors alleging that he had made offensive remarks to colleagues and treated nurses poorly, also writing that he “would delay care to patients because he wanted to participate in procedures unrelated to his patients because they interested him.”

Zywiec maintains an online medical practice, where he describes himself as “an international medical doctor and board-certified indigenous medicine provider” and offers a range of services, including a $150, 30-minute, “Medical Excuse/Note” consultation that yields a “legitimate medical excuse tailored to your situation.” On X, where he has amassed a following in the tens of thousands, Zywiec regularly shares content about the dangers of vaccines.

The promotional video on Frontline’s website describes the exemptions as “signed by state-licensed physicians with full credentials.” Zywiec’s name does not appear in a national database of licensed physicians maintained by the Federation of State Medical Boards. (In a brief email, Zywiec referred interview requests to Frontline. He did not answer a list of questions from Undark, and Frontline did not respond to a question about Zywiec’s license status.)

The exemption that Zywiec had signed for Clerkin was denied. In a letter, the school district explained that New York law requires exemptions to be signed by a physician licensed in the state. Clerkin said that she was aware Zywiec was not licensed in New York, but Frontline seemed confident in their approach, and she thought it might work. That did not pan out, she said. “I feel like they talk this big thing,” Clerkin said. But, she added, “if you know that you can’t help these children, and you’re just preying on these mothers who will do anything for their children, that is evil.”

Some Frontline exemptions do get through, at least in New York. “I can certainly tell you that there have been some people, even this year, who have been able to get their Frontline Health waivers accepted,” Davenport told Undark. But, he said, courts have not tested the argument that an exemption invoking federal law will trump the state’s requirement that the exemption comes from a New York-licensed physician. He does not recommend Frontline to clients. “I basically tell them, although Frontline may technically be correct, it’s not a good legal position for you to be in,” Davenport said. “And so I always advise them to try to get a New York state waiver signed by a New York state doctor and then submit that, because that puts you in the best legal position.”

In a video on its website, Frontline warns potential clients that exemptions may be denied, noting that the group “cannot guarantee that an unknown person you are engaging with is going to abide by federal laws.” But Rita Palma, a health freedom activist on Long Island who has worked with many families seeking medical exemptions, told Undark that she thinks parents are still confused about the limitations of the waivers. “What I’m getting from parents is that Frontline Health Advocates say that federal law overrides state law,” she said. Whether or not that’s true in the case of vaccine exemptions remains unclear.

The $495 fee—extra for expedited service—is a steep price for some families. “They’ve made a nice killing in New York,” Palma said. “I hate to put it like that, but they’ve definitely gotten a lot of parents to pay them to get exemptions.”

It’s difficult to know how many waivers Frontline has sold. In online forums, people describe successes with schools. “I got lifetime medical exemptions for my children,” one parent wrote in a Facebook group in April, noting that she was not affiliated with Frontline. The group is “replete with lawyers to respond to any pushback from schools,” she added.

One mother in Connecticut told Undark that she had contacted Frontline in 2024, when her son needed a flu shot to stay in daycare. “I was looking around for a way to get an exemption,” she said. (The mother spoke on condition of anonymity, citing a professional need for privacy.) After a phone call with a licensed pediatrician in Texas, she received an exemption. The daycare, she said, accepted it. “It was a pretty smooth experience, overall,” she said.

“I was aware that it was a gamble,” the mother said; Frontline had told her the exemption might not be accepted. “But then they kind of were like, well, you know, technically, if they don’t accept it, it’s illegal because it’s protected by ADA and all that kind of thing,” she said.

The group has attracted attention from some public health officials. In Los Angeles County, a public health department website is topped by a large red banner warning that Frontline exemptions don’t work in California. In October 2024, in Connecticut, minutes from a meeting of the state’s School Nurse Advisory Council described Frontline as providing what the council believed to be “fraudulent” exemptions to families. A spokesperson for Connecticut Public Health, Brittany Schaefer, told Undark in late September that Frontline is the subject of “an active investigation.”

Undark asked three legal experts to review a copy of an exemption issued to a family in New York in September 2024 and obtained via court records. “It seems to be a fill-in-the-blank type of form,” said Barbara Hoffman, an expert in disability law at Rutgers Law School. The waiver, Hoffman believes, overstates the penalties generally levied for ADA infractions. School districts, employers, or others who received this form, she speculated, might feel like “it’s not worth the effort to reject this.”

“This looks like an official document,” she added, highlighting the seal of the Department of Justice and references to potential civil penalties. “It’s designed to intimidate somebody who doesn’t really know better, or just doesn’t want to risk any potential litigation.”

Could invoking the ADA really override state-level vaccine requirements? Reiss, the UC Law San Francisco expert, was skeptical, noting that state law has generally held in similar cases. “My expectation,” she wrote in an email, “is that that won’t hold.”

This article was originally published on Undark. Read the original article.

http://arstechnica.com/

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Trump’s swift demolition of East Wing may have launched asbestos plumes

No response

On Thursday, Sen. Edward Markey (D-Mass.) sent a letter to ACECO, asking if it followed federal health and safety standards to mitigate risks of asbestos. “ACECO’s work falls squarely within a network of federal regulations governing demolition, hazardous-material handling, and worker protection,” the senator wrote.

In a separate letter Thursday, Sens. Sheldon Whitehouse (D-R.I.), Martin Heinrich (D-N.M.), and Gary Peters (D-Mich.) sought “lawful transparency” on the demolition, including the asbestos abatement plan.

In DC, asbestos abatement processes can only be done by a licensed contractor, who is required to notify the Department of Energy and Environment 10 days in advance of such work, then post notices of asbestos abatement around the area of work three days beforehand.

But reporting by the Post found that ACECO is not licensed to abate asbestos in DC. “Our understanding is that as of August 18, 2022, Aceco LLC is no longer engaged in asbestos abatement services,” a DC Department of Licensing and Consumer Protection spokesperson told The Post. “The company’s asbestos abatement license in the District of Columbia was voluntarily canceled by the owner on that date.”

ACECO has not responded to questions from media and, amid the White House work, has taken down its website for the most part, only providing a page that says it’s under construction.

ADAO’s Reinstein told the Post that the White House has not responded to the organization’s letter. “I learned 20 years ago when I cofounded ADAO, no response is a response,” she told the Post.

As Ars Technica has reported, Trump has a startlingly supportive stance on the use of asbestos. In his 1997 book The Art of the Comeback, Trump wrote that asbestos is “100% safe, once applied.” He blamed the mob for its reputation as a carcinogen, writing: “I believe that the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal.”

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measles-outbreak-investigation-in-utah-blocked-by-patient-who-refuses-to-talk

Measles outbreak investigation in Utah blocked by patient who refuses to talk

A measles investigation amid a large, ongoing outbreak at the Arizona-Utah border has hit a roadblock as the first probable case identified in the Salt Lake City area refuses to work with health officials, the local health department reported this week.

There have been over 150 cases collectively across the two states, mostly in northwestern Mohave County, Arizona, and the southwest health district of Utah, in the past two months. Both areas have abysmally low vaccination rates: In Mohave County, only 78.4 percent of kindergartners in the 2024–2025 school year were vaccinated against measles, according to state records. In the southwest district of Utah, only 80.7 percent of kindergartners in the 2024–2025 school year had records of measles vaccination. Public health experts say vaccination coverage of 95 percent is necessary to keep the disease from spreading in a community.

While the outbreak has largely exploded along the border, cases are also creeping to the north, toward Salt Lake County, which encompasses the city. Utah County, which sits just south of Salt Lake County, has identified eight cases, including a new case reported today.

Uncooperative case

Salt Lake County likely has a new one, too—the first for the county this year—as well as possible exposures. But, they can’t confirm it.

County health officials said that a health care provider in the area contacted them late on Monday to tell them about a patient who very likely has measles. The officials then spent a day reaching out to the person, who refused to answer questions or cooperate in any way. That included refusing to share location information so that other people could be notified that they were potentially exposed to one of the most infectious viruses known.

“The patient has declined to be tested, or to fully participate in our disease investigation, so we will not be able to technically confirm the illness or properly do contact tracing to warn anyone with whom the patient may have had contact,” Dorothy Adams, executive director of Salt Lake County Health Department, said in a statement. “But based on the specific symptoms reported by the healthcare provider and the limited conversation our investigators have had with the patient, this is very likely a case of measles in someone living in Salt Lake County.”

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calley-means-is-out-of-the-white-house;-casey-means-misses-senate-hearing

Calley Means is out of the White House; Casey Means misses Senate hearing

In a statement Thursday, government watchdog Public Citizen cheered the news of his departure.

“The Trump Administration has wildly abused the Special Government Employee designation to shoehorn powerful people into official jobs in a way that allowed them to evade financial transparency and anti-corruption restraints,” Public Citizen Democracy Advocate Jon Golinger said. “The clock ran out on Mr. Means, and we’re glad he finally resigned.”

“Charlatan”

Casey has a background in actual medicine, with a degree from Stanford Medical School, but she dropped out of her residency, holds no active medical license or board certification, and has gone all in on “functional” medicine, which is an ill-defined form of alternative medicine. She co-founded a company called Levels, which promotes intensive health tracking, including continuous blood glucose monitoring for people who don’t have prediabetes or diabetes. (Another Levels co-founder is Sam Corcos, now the chief information officer for the Department of the Treasury, who, as The New Yorker reported, led the effort to dismantle the Internal Revenue Service on behalf of Elon Musk’s Department of Government Efficiency.)

Casey and Calley Means made a name for themselves among the MAHA crowd with their 2024 book Good Energy: The Surprising Connection Between Metabolism and Limitless Health. The book encourages health-conscious readers to avoid processed foods, seed oils, fragrances, a variety of home care products, fluoride, unfiltered water, bananas (when eaten alone), receipt paper, and birth control pills. It includes a chapter titled “Trust Yourself, Not Your Doctor.”

Health experts have sharply criticized her nomination to the role of surgeon general. The health network Defend Public Health released a statement Thursday urging lawmakers to reject her “quackery.”

“The US Surgeon General is the leading US government voice on public health issues,” said DPH member and physician Oni Blackstock, an HIV expert and former assistant commissioner at the New York City Department of Health and Mental Hygiene. “That person must be someone Americans can trust to give credible advice based on solid science and real data, not a charlatan who specializes in selling expensive, unproven tests and treatments.”

Calley Means is out of the White House; Casey Means misses Senate hearing Read More »