Thousands of people with a severe dust mite allergy could benefit from a “life changing” new daily treatment.

During the hearing to consider his nomination to lead the Department of Health and Human Services, Robert F. Kennedy Jr. spoke at length about issues in health and medicine, including the cause of chronic illnesses, Covid-19 and ultraprocessed foods.Here is a running list of key health claims, fact-checked by our reporters.Chronic DiseaseMr. Kennedy’s opening statement focused on rising chronic health conditions, saying there was a crisis in children’s health in the United States. Many experts agree — though they disagree about the causes.Forty percent of children have a chronic health condition, and the figure is higher for adolescents when obesity is included.Roughly one in 36 children is diagnosed with an autism spectrum disorder, according to data from the Centers for Disease Control and Prevention. One in four has an allergy or eczema, and rates of Type 2 diabetes have been rising in those 19 and under every year.And while Type 2 diabetes rates are rising, they are still low: According to the American Diabetes Association, it occurs in 0.35 percent of Americans under the age of 20.Who Covid-19 AffectsSenator Michael Bennet of Colorado pressed Mr. Kennedy on a statement Mr. Kennedy made in 2023 in which he suggested that the coronavirus targeted and spared certain ethnic groups.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Based on an ARIC cohort analysis, supine hypertension may be more predictive of cardiovascular events than seated hypertension. (JAMA Cardiology)
Blood pressure (BP) readings in public, noisy environments were still fairly accurate. (Annals of Internal Medicine)
One lot of Provepharm’s phenylephrine hydrochloride is under voluntary recall by the manufacturer due to “visible black particulate matter,” according to an FDA alert.
Racial minorities and people on Medicaid were still taking baby aspirin in 2021-2023 despite guideline warnings. (JAMA)
For patients with stable chest pain, management guided by coronary CT angiography was still associated with a sustained reduction in coronary heart disease death or myocardial infarction 10 years into the SCOT-HEART trial. (The Lancet)
Taken from the same blood sample, high-sensitivity cardiac troponin I had a slightly higher diagnostic accuracy for heart attacks, while high-sensitivity cardiac troponin T had higher prognostic accuracy for all-cause and cardiovascular death. (Journal of the American College of Cardiology)
Left atrial appendage (LAA) closure appeared promising for people with atrial fibrillation on hemodialysis, based on an international registry. (JACC: Clinical Electrophysiology)
Imperative Care announced FDA 510(k) clearance of the Zoom stroke thrombectomy system, including its large-bore .088″ catheter.
It’s not just cigarettes: Users of cigars, pipes, and smokeless tobacco displayed subclinical markers of inflammation and atherosclerosis in a cross-sectional study. (Circulation)
Central adiposity, or a high waist-to-height ratio, was prevalent in almost every patient with heart failure with preserved ejection fraction in the PARAGON-HF trial. (European Heart Journal)
The Society of Thoracic Surgeons Intermacs Risk Model was unveiled as a tool to predict 90-day mortality risk from durable left ventricular assist device implantation. (Annals of Thoracic Surgery)
Modeling showed the best performing clinical decision rule regarding when to terminate resuscitation efforts for in-hospital cardiac arrest: when the patient had an unwitnessed, unmonitored cardiac arrest, an initial rhythm of asystole, and resuscitation duration of at least 10 minutes. (JAMA Internal Medicine)
Traditional risk factors were unable to predict exercise-related sudden cardiac death in those with hypertrophic cardiomyopathy. (Heart)
And in young people who died from sudden cardiac death due to coronary artery disease, there was no evidence that screening for carotid or aortic plaque would have flagged the event. (European Journal of Preventive Cardiology)
Among toddlers with congenital heart disease, those who received cardiac inpatient neurodevelopmental interventions wound up having reduced delirium and higher cognitive scores, one hospital found. (JAMA Network Open)
The anti-PCKS9 adnectin drug lerodalcibep failed to meet noninferiority criteria against evolocumab (Repatha) for reducing LDL cholesterol in a homozygous familial hypercholesterolemia population. (Lancet Diabetes & Endocrinology)

Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Please enable JavaScript to view the comments powered by Disqus.

President Trump said he would take health agencies in a new direction on the campaign trail and has chosen some controversial nominees to help him achieve his goal, including Robert F. Kennedy Jr., Trump’s pick for HHS secretary.
However, it remains unclear how much could actually change if Kennedy were to be confirmed. To answer that question, MedPage Today spoke with legal experts, former CMS and White House officials, and others who worked alongside health agencies to gauge the potential for substantial reforms across HHS and its sub-agencies.
Can Kennedy Terminate Employees at FDA, Other Agencies?
In October, Kennedy posted on X that “FDA’s war on public health is about to end.” He criticized the agency’s “aggressive suppression” of a number of unproven therapies, including ivermectin and hydroxychloroquine, and warned, “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.”
If confirmed as HHS secretary, would Kennedy have the authority to overhaul the FDA and clear out “entire departments,” as he said he planned to do? Lawrence Gostin, JD, a professor at Georgetown Law School in Washington, D.C., said Kennedy has “extensive power” to reorganize the federal workforce, but it isn’t unlimited.
He may get some help from Trump, who issued an executive order to reclassify certain federal employee positions in a way that would make it easier to fire them at will, Gostin said. This order seeks to restore a 2020 executive order, which Biden rescinded in January 2021.
Public servants do have civil service and whistleblower protections, Gostin noted. “They can complain publicly about malevolent intentions,” and would likely have a “valid legal challenge” if they sued that could at least delay the reclassification process.
In April, the Office of Personnel Management under President Biden issued a final rule to prohibit this type of reclassification. If the president was to “follow the letter of the law,” he would need to revoke the prior rule, which includes issuing a notice, holding a hearing, and having “good reasons” for that revocation that could withstand court challenges, Gostin said. “I think [Trump] may succeed, ultimately, if he perseveres,” but he also might drop these efforts if enough civil servants retire or quit on their own.
Steven Balla, PhD, an associate professor of political science at George Washington University in Washington, D.C., told MedPage Today, “I’m convinced that a lot of this is rhetoric that’s designed to demoralize and shrink the federal workforce through ‘voluntary’ resignations.”
Gostin said that the only “real check” on Trump’s authority relates to centers or divisions having statutory functions — meaning their funding or authorities come directly from Congress. In those cases, Trump and Kennedy would need Congress’s help to undo or eliminate those functions. “But if it’s simply a matter of reorganizing how an agency is constituted, [Kennedy] has quite extensive power to do that, and that’s alarming,” he added.
Ashish Jha, MD, dean of the Brown University School of Public Health in Providence, Rhode Island, and former White House COVID-19 Response Coordinator under Biden, agreed with Gostin. “He can definitely reorganize … but it’s going to be hard to shut entire agencies down,” he said.
Tom Scully, JD, who served as CMS administrator under President George W. Bush, noted that it wouldn’t hurt to trim down at least one of the agencies a bit. “I went through the [CMS org chart] and there are offices I never heard of when I was there 20 years ago,” he told MedPage Today.
Scully, who sees himself as a “pretty moderate Republican,” said if he was in government now he would probably eliminate 25% of the offices he saw on the org chart.
On the other hand, the Trump administration’s effort to require all federal employees to go to their offices 5 days a week could have unintended consequences as it potentially forces a lot of early retirements, he added.
“Some people will say, ‘Great.’ I would say, ‘It depends,'” said Scully, who is now a principal at Federal Health Policy Strategies, a Washington consulting firm. “If you lose the good people, you’re in trouble.”
Can Kennedy Pause Research on Infectious Diseases, Direct Half of NIH Funding to Holistic Health?
At an anti-vaccine conference in 2023, Kennedy, who was still running as an independent candidate for president, said he would tell NIH scientists, “Thank you for [your] public service. We’re going to give infectious disease a break for about 8 years.” Later, in a September 2024 editorial for the Wall Street Journal, in which he endorsed Trump for president, Kennedy suggested that half of the NIH’s budget should be directed to “preventative, alternative, and holistic approaches to health.”
Gostin said, as HHS secretary, Kennedy will have “certain flexibility” to allocate where research dollars are spent, but at NIH in particular, Congress funds certain centers and programs. So, “without congressional action to readjust those financial flows, he’s going to have relatively limited ability to make the kind of radical changes that he wants to see,” he noted.
Also, given the number of Republicans in Congress with a vested interest in research on childhood cancers, heart disease, diabetes, and even infectious diseases, it would be “very, very difficult,” although “not impossible” to change that, he added.
Can Kennedy Reverse Vaccine Approvals, Overhaul Vaccine Advisory Committees?
FDA approvals are granted at the center director level, which is not currently a political appointment, but the HHS secretary does make the final decision, Gostin said.
Paul Offit, MD, a former member of the Advisory Committee on Immunization Practices (ACIP) at CDC and a current member of the FDA’s Vaccines and Related Biological Products Advisory Committee, noted that if the FDA’s vaccine advisory committee recommends a vaccine be licensed and the FDA agrees, the HHS secretary could disagree. “He can say, ‘I think this vaccine hasn’t been tested well enough,'” or even that existing vaccines have not been tested enough.
Kennedy has previously made such arguments. In 2021, he lobbied the FDA to revoke the authorization of the COVID vaccines, even while thousands of people were dying weekly from the virus. In recent months, however, Kennedy has appeared to moderate his stance, telling Republican senators that he won’t take away vaccines and that he just wants to make safety and efficacy data more readily available.
But Offit noted that Kennedy still believes vaccines cause autism despite “abundant evidence” that they do not. “When he says … ‘I just care about vaccine safety,’ what he really means is he wants to see studies done to confirm his immutable, fixed, science-resistant beliefs,” he said.
Donald Berwick, MD, president emeritus of the nonprofit Institute for Healthcare Improvement in Boston and a former CMS administrator under President Obama, noted that to change vaccination policies reflected in CDC regulations, an HHS secretary would have to follow the rule-making process and provide a 30- or 60-day comment period under the Administrative Procedure Act.
“You can always ignore the law, but when you’re a public official … you’ve taken an oath, and violating that oath has consequences,” Berwick said, adding that there needs to be enforcement of those consequences.
Jha noted that as HHS secretary, Kennedy would yield “soft power” over the heads of other agencies, including CMS, FDA, NIH, and CDC. “They’re not going to want to make decisions that are going to upset him,” he said.
Gostin argued that making vaccine bans the “holy grail” of an anti-vaccine agenda is flawed, given the many ways Kennedy, as HHS secretary, could potentially undermine trust in immunizations. Although he has the power to reverse an approval, Kennedy might hesitate to do so given the “enormous” backlash he could face, and likely would instead undermine vaccines in other ways — such as by appointing vaccine skeptics to advisory committees such as ACIP, he said.
Balla pointed out that there are stipulations in the Federal Advisory Committee Act (FACA) that govern how these committees are constituted and operate. When there’s an opening, usually a call is issued in the Federal Register and an open application process follows. Balla also noted that a share of seats are reserved for certain stakeholders to ensure committees are balanced.
In the “bad old days” before FACA, Balla said, committees would hold non-public meetings and be stacked with certain types of stakeholders. The balance and solicitation requirements seek to prevent that. “So, that makes it harder to, just by fiat, change the composition of the advisory committee,” he noted.
Still, as Gostin pointed out, the CDC director makes nominations for the advisory committees, and appointments are ultimately determined by the HHS secretary. And Kennedy, by leveraging anti-vaccine allies on these committees, could ensure that even approved vaccines would not receive coverage under the Affordable Care Act.
“Even more insidiously,” he added, “he could cherry-pick data, [and] use misleading health communications to foment doubt and distrust in certain vaccines,” and “a number of red states” would likely change their school immunization requirements as a result.
Additional Checks and Balances
Other forces could limit Kennedy’s plans, but for Offit, Congress is unlikely to be one of them. “The mere fact that they might confirm him tells you that you should worry about them ever pushing back” on his actions, he said.
Kennedy’s confirmation hearing with the Senate Finance Committee is scheduled for Wednesday, and he has a hearing with the Senate Committee on Health, Education, Labor, and Pensions on Thursday.
For Jha, one check on Kennedy’s power is the sheer number of rules that government officials have to follow. “It’s hard to make reform inside government … You can do window dressing, but substantive reform is very, very hard, and I don’t know that [Kennedy has] got the team or the capability or the patience to do it,” he said. Plus, if he’s not careful, lawsuits will inevitably follow, he added.
“The truth is that I think the biggest bulwark against really egregious behavior is likely to come from the courts,” Jha said. “I think at least for the next 2 years … if anybody is doing anything, it’s going to be the courts.”

Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow

Disclosures

Please enable JavaScript to view the comments powered by Disqus.

Allan-Blitz is a pediatrician and adult medicine specialist. Klausner is a professor of population and public health sciences.

Sexually transmitted infections (STIs) have a major impact on the heath of people every day — from diseases like AIDS and syphilis to drug-resistant gonorrhea and herpes. But few know that chlamydia, one of the most common STIs, is a major cause of infertility when left untreated. Too many people are unaware of the long-term complications of chlamydia and how a simple test and cheap treatment can save fertility.
Few schools provide in-depth education about STIs. These infections remain highly stigmatized in most communities and are rarely talked about — even by healthcare professionals. Aside from ob/gyns and other sexual health experts, there is a serious lack of knowledge in this area. The ongoing silence and lack of awareness pose barriers to testing and treatment.
We urgently need new federal and state efforts to reduce stigma and provide STI testing and treatment to prevent infertility. Infertility prevention can improve the health of all women and families.
The Impact of Undetected and Untreated Chlamydia
In 2023 there were 1.6 million reported cases of chlamydia in the U.S., and likely twice that many went undetected and unreported. One in 10 women with chlamydia will develop long-term infection of the reproductive organs (pelvic inflammatory disease), often without any symptoms. Over time, chronic infection will rob women of their fertility. It is estimated that for every 150 untreated chlamydial infections in the U.S., there will be at least one case of permanent sterility.
Infertility can be a very difficult issue for people who want to have children. Infertility is a common cause of anxiety and depression, and can also contribute to relationship stress and divorce. Infertility is also very difficult and expensive to treat. The costs of infertility treatment are borne by everyone — families, employers, and taxpayers. Cases of infertility caused by chlamydia cost about $135 million in medical expenses every year.
Testing and Treating Chlamydia
Chlamydia, however, is easily detectable through testing and can be treated with a single course of antibiotics. What makes treatment challenging is that most women with chlamydia do not know they have it. In 70-75% of cases, the infection in women has no symptoms, which is why it’s known as the “silent STI.” The only way to know if you or your patient has chlamydia is through testing. The CDC recommends that all sexually active women get tested every year until the age of 25. Women 25 and older should get tested if they have new sex partners or a partner with an STI. Even with those recommendations, however, only about half of women who should get tested, get tested regularly.
We need a unified program to increase awareness about chlamydia and infertility among policy makers, medical providers, and young women. While insurance companies generally reimburse for STI testing, we need to make testing and treatment easier for women to access.
Newer FDA-approved tests allow women to collect swabs for testing in their own home and mail the swabs to nearby testing laboratories. Meanwhile, the CDC is working on a cheap, 15-minute test that people could buy in a store, or doctors could use in their office, without the need to involve a testing lab. Very accurate, more expensive, 30-minute chlamydia tests do exist, but many doctors don’t use these tests because most insurers don’t reimburse enough to cover the cost of testing; instead doctor’s offices use standard testing, which can take 1-to-2 days or more for results.
For 20 years, from 1993 to 2013, Congress supported the National Infertility Prevention Project. That program paid states and organizations to test for and treat chlamydia as well as other STIs, specifically in women. A similar program today could help millions of American women and restore the health and fertility of our nation.
Research shows that public funding for STI prevention works. For every 1% increase in federal funding for prevention, rates of chlamydia decrease by 0.17%. In 2023, the CDC received only about $110 million for STI prevention, or approximately 35 cents per U.S. resident. Doubling current federal funding might prevent over 2,200 cases of infertility caused by chlamydia in a single year, and only use a very small amount of the overall federal budget. That means hundreds or thousands more women would be able to have children, and more families would avoid the challenges and stigma of infertility.
Given the importance that we all place on healthy pregnancies and families, addressing preventable infertility must become a well-funded national priority.
Lao-Tzu Allan-Blitz, MD, MPH, is a pediatrician and adult medicine specialist at Brigham and Women’s Hospital and Harvard Medical School in Boston. Jeffrey D. Klausner, MD, MPH, is a professor of population and public health sciences at the University of Southern California Keck School of Medicine in Los Angeles, and a former CDC medical officer.

Disclosures
Klausner has received consulting fees from Visby Medical, a producer of a point-of-care STI test for women, and bioMerieux, a maker of infectious disease tests.

Please enable JavaScript to view the comments powered by Disqus.

U.S. public health officials have been told to stop working with the World Health Organization (WHO), effective immediately.
A CDC official, John Nkengasong, MSc, PhD, sent a memo to senior leaders at the agency on Sunday night telling them that all staff who work with the WHO must immediately stop their collaborations and “await further guidance.”
Experts said the sudden stoppage was a surprise and would set back work on investigating and trying to stop outbreaks of Marburg virus and mpox in Africa, as well as brewing global threats. It also comes as health authorities around the world are monitoring bird flu outbreaks among U.S. livestock.
The Associated Press viewed a copy of Nkengasong’s memo, which said the stop-work policy applied to “all CDC staff engaging with WHO through technical working groups, coordinating centers, advisory boards, cooperative agreements, or other means — in person or virtual.” It also says CDC staff are not allowed to visit WHO offices.
President Trump last week issued an executive order to begin the process of withdrawing the U.S. from WHO, but that did not take immediate effect. Leaving WHO requires the approval of Congress and that the U.S. meets its financial obligations for the current fiscal year. The U.S. also must provide a 1-year notice.
His administration also told federal health agencies to stop most communications with the public through at least the end of the month.
“Stopping communications and meetings with WHO is a big problem,” said Jeffrey Klausner, MD, MPH, a University of Southern California public health expert who collaborates with WHO on work against sexually transmitted infections.
“People thought there would be a slow withdrawal. This has really caught everyone with their pants down,” said Klausner, who said he learned of it from someone at CDC.
“Talking to WHO is a two-way street,” he added, noting that the two agencies benefit from each other’s expertise. The collaboration allows the U.S. to learn about new tests, new treatments, and emerging outbreaks — information “which can help us protect Americans abroad and at home,” Klausner said.
The CDC details nearly 30 people to WHO and sends many millions of dollars to it through cooperative agreements. The U.S. agency also has some of the world’s leading experts in infectious diseases and public health threats, and the two agencies’ staffers are in daily contact about health dangers and how to stop them.
The collaboration halt isn’t the only global health effect of Trump’s executive orders. Last week, the president froze spending on another critical program, PEPFAR, or the President’s Emergency Plan for AIDS Relief.
The anti-HIV program is credited with saving 25 million lives, including those of 5.5 million children, since it was started by Republican President George W. Bush. It was included in a Trump administration freeze on foreign aid spending slated to last at least 3 months.
PEPFAR provides HIV medication to more than 20 million people “and stopping its funding essentially stops their HIV treatment,” International AIDS Society President Beatriz Grinsztejn, MD, PhD, said in a statement. “If that happens, people are going to die and HIV will resurge.”
A U.S. health official confirmed that the CDC was stopping its work with WHO. The person was not authorized to talk about the memo and spoke on condition of anonymity.
A WHO spokesperson referred questions about the withdrawal to U.S. officials.
Officials at HHS didn’t immediately respond to an emailed request for comment. And CDC officials didn’t respond to the AP’s request to speak with Nkengasong about the memo.

Please enable JavaScript to view the comments powered by Disqus.

Note that some links may require registration or subscription.
The White House budget office ordered a pause to all grants and loans disbursed by the federal government. (Washington Post)
The acting NIH director told scientists that clinical trials could continue, despite a pause in communications about their work. (NBC News)
Senior officials at U.S. Agency for International Development, including leaders overseeing global health aid, were put on paid leave in response to what an official characterized as resistance to President Donald Trump’s policy. (New York Times)
Have the Trump administration’s changes at federal health agencies affected you? Contact MedPage Today here to tell your story.
Here’s what Robert F. Kennedy Jr., Trump’s pick to lead HHS, might face in his nomination hearings this week. (KFF Health News)
The Wall Street Journal’s editorial board came out in opposition to Kennedy. (The Hill)
Kennedy said he’s open to seizing drug patents in a closed-door meeting with Senate Finance Committee staffers. (Politico)
Heart disease remains a leading cause of death, fueled by increases in risk factors like obesity and high blood pressure. (Circulation)
The shortage of immediate-release mixed amphetamine salts (Adderall) to treat attention-deficit hyperactivity disorder may have prompted a scramble towards alternative stimulants for kids. (American Academy of Pediatrics)
Trump said he would consider rejoining the World Health Organization, but said that they “would have to clean it up.” (Reuters)
China says it’s “extremely unlikely” that the COVID-19 pandemic was caused by a lab leak, as the CIA recently said. (The Hill)
While a bird flu pandemic in humans is not inevitable, recent developments seem worrisome. (New York Times)
The first U.S. outbreak of H5N9, a strain of bird flu rarer than H5N1, was reported on a California duck farm. (Reuters)
An infectious disease expert warned that windblown bird poop may transit the virus. (CBS News)
In South Carolina, bird flu is being blamed for soaring eggs prices of $9 a dozen. (The Post and Courier)
Acting HHS head Dorothy Fink, MD, said the agency will review government programs to ensure taxpayer dollars aren’t being used for elective abortions.
Trump signed executive orders to reinstate military service members who were dismissed for not getting vaccinated and eliminate “gender radicalism” in the military. (ABC News)
A cancer patient had her arm suddenly amputated. Her open-casket funeral for the arm went viral. (USA Today)

Please enable JavaScript to view the comments powered by Disqus.

Water bead toys have the potential to cause not only intestinal obstruction in children who ingest them, but also neurotoxicity, a case study suggested.
A 13-month-old female who was previously healthy presented to the emergency department with vomiting, lethargy, and weight loss over several weeks along with insomnia and facial dermatitis, reported a group led by Ashley Haugen, of the nonprofit advocacy organization That Water Bead Lady and the mother of the patient.
During an exploratory laparotomy, a mass consisting of water beads was removed from the child’s distal small intestine, Haugen and colleagues noted in Pediatrics.
Following removal of the mass, the patient’s facial dermatitis resolved. However, her speech along with gross and fine motor, sensory, and neurological functions continued to worsen. A second surgical procedure removed multiple fragments of water bead material from the child’s large intestine.
“This is an essential area for pediatric medical awareness because the dangers of water beads extend beyond what is commonly understood,” Haugen told MedPage Today in an email. “While physical obstructions are often the focus, the potential chemical toxicity of water beads, including neurotoxic and systemic effects have been largely overlooked.”
These beads are made of polymerized acrylamide monomer, which can be toxic at high levels. And they can clump together into a gelatinous mass.
“In cases where beads remain in the body for prolonged periods, chemical exposure could exacerbate the injury even beyond the physical obstruction,” Haugen added. “The material may contain residual monomers, degrade over time, impact digestive tract function, or disrupt gut microbiota — factors that cannot be fully replicated in testing or reliably predicted. Our paper highlights the importance of clinicians recognizing the duality of risk — both physical and chemical — which is often overlooked and should be an integral part of the clinical evaluation process.”
Along with marketing to children generally as toys, water bead sales are also targeted to children with autism and sensory processing disorders as sensory-based therapies, noted Patrick Reeves, MD, and Eric Pasman, MD, both of the Uniformed Services University of the Health Sciences in Bethesda, Maryland, in a commentary accompanying the case study in Pediatrics
“Without [pending] consumer protections, pediatrics should counsel families, including those at high risk based on age or developmental status, on the dangers of water bead ingestion,” they wrote. “There must be continued advocacy with the [Consumer Product Safety Commission] to mitigate the dangers posed by water beads.”
Overall, reports of children swallowing water beads have risen in the last decade, according to a systematic review presented at the American Academy of Pediatrics’ annual meeting in Orlando in September. And members of the American Medical Association House of Delegates also have called attention to reported injuries from the products.
In the case study by Haugen and colleagues, the patient had a normal developmental trajectory prior to water bead ingestion, meeting standard milestones like walking and speaking, as well as normal hearing.
However, at age 17 months, 3 months after surgical removal of the water bead mass, the patient’s pediatrician and medical records indicated that she demonstrated the following: motor incoordination, tremor, myoclonus, muscle weakness (minimal use of right hand), extremity hypotonia, gait abnormality, expressive receptive language delay, sensory processing issues with temperature and resistance to items touching feet and hands, delayed problem solving, and abnormal hearing.
Meanwhile, the patient’s brain MRI and chromosomal microarray were normal, “ruling out structural and genetic etiology,” Haugen and colleagues reported. And her parents confirmed with the water bead retailer and manufacturer that the products were made of polyacrylamide.
Because the patient’s symptoms and clinical progression were consistent with acrylamide exposure, her developmental pediatrician made a presumptive diagnosis of encephalopathy associated with acrylamide toxicity.
At age 20 months (6 months after surgery), formal assessment indicated the patient’s gross motor age was 18 months, her fine motor age was 16 months, her receptive language age was 10 months, and expressive language age was 12 months. And at 22 months of chronological age, histopathology of the colon showed mild eosinophilic inflammation and lymphoid aggregates consistent with an immune response.
Starting at age 17 months, the patient received specialized skills training four times per month for more than 3 months, which was aimed at addressing lack of coordination and fine motor skill challenges. Starting at 22 months, the patient received speech therapy eight times per month. And the patient also was initiated on a low-dose regimen of the sodium channel blocker oxcarbazepine (Trileptal) to mitigate hyperexcitability of damaged nerves.
At around 6 years of age, the patient was recommended to start 20 to 30 minutes of speech therapy five times a week and to get special education services in a general education setting to address functional deficits. At 8 years of age, the patient had made significant progress and speech therapy dropped to twice a week.
Limitations of the case study included lack of free acrylamide monomer blood level measurement, which is typically available only in research contexts, Haugen and colleagues noted. And “significant delay” between surgical intervention and identification of exposure “further precluded the possibility of obtaining accurate measurements.”

Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

Disclosures
Haugen is president of the nonprofit advocacy organization That Water Bead Lady and mother of the patient described in the case study. Neither co-authors of the case study nor authors of the accompanying commentary reported any relevant conflicts of interest.

Primary Source
Pediatrics
Source Reference: Haugen A, et al “Intestinal obstruction and neurotoxicity associated with water bead ingestion” Pediatrics 2025; DOI: 10.1542/peds.2023-065575.

Secondary Source
Pediatrics
Source Reference: Reeves PT, Pasman EA “Risks of water bead ingestion” Pediatrics 2025; DOI: 10.1542/peds.2024-069447.

Please enable JavaScript to view the comments powered by Disqus.

A biomarker signature using brain activity measurements predicted pain sensitivity.The signature combined sensorimotor peak alpha frequency and corticomotor excitability.The study involved 150 people who received nerve injections to test prolonged pain.

A novel biomarker signature that assessed cortical activity predicted individual pain sensitivity, the PREDICT validation study showed.
The signature consisted of two measures: sensorimotor peak alpha frequency (PAF) and corticomotor excitability (CME). In the training set, it correctly classified study participants with high or low pain sensitivity with an area under the curve (AUC) of 1.00.
In the test set, the signature had an AUC of 0.88 (95% CI 0.78-0.99), reported David Seminowicz, PhD, of the University of Western Ontario in London, Canada, and co-authors in JAMA Neurology.
Results were reproduced across a range of parameters. The PAF and CME biomarkers showed good to excellent test-retest reliability.
“The combination of biomarker accuracy, reproducibility, reliability, and pain model validity suggests high potential for clinical translation, particularly in predicting the transition from acute to chronic pain,” Seminowicz and colleagues wrote.
PAF is the dominant sensorimotor cortical oscillation in the 8-12 Hz (alpha) range. CME is the efficacy of relaying signals from the primary motor cortex to peripheral muscles. Previous work showed that slower PAF before pain onset and reduced CME during prolonged pain were associated with more pain, while faster PAF and increased CME were associated with less pain.
“Given that individuals who experience higher pain in the early stages of a prolonged pain episode (e.g., postsurgery) are more likely to develop chronic pain in the future, slow PAF before an anticipated prolonged pain episode and/or CME depression during the acute stages of pain could be predictors for the transition to chronic pain,” the researchers noted.
Identifying objective biomarkers to track pain severity has been dubbed “the holy grail” of pain neuroscience, observed Prasad Shirvalkar, MD, PhD, of the University of California San Francisco, and Christopher Rozell, PhD, of the Georgia Institute of Technology in Atlanta, in an accompanying editorial.
“While pain is among the most fundamental, ubiquitous, and adaptive experiences that can befall an organism, there is still a murky understanding of how pain is generated in the nervous system,” they noted. The consensus on mechanisms underlying chronic pain — pain that persists for more than 3 months, which affects 21% of U.S. adults — is even less clear.
The PAF and CME signature “will likely have broad applicability across many medical fields,” Shirvalkar and Rozell said. “If successfully translated into clinical practice, biomarkers that predict a transition to chronic pain would have a tremendous impact for the treatment of millions of individuals.”
Advances in pain biomarkers also need to incorporate advances in global neuroethics guidance and address ethical concerns about pain treatment, the editorialists pointed out. “We must take care to ensure that quantitative measures do not supplant lived experience reports, introduce distrust in the physician-patient relationship, set unrealistic patient expectations, or exacerbate existing inequalities in pain treatment across this vulnerable population,” they wrote.
The PREDICT validation study included 150 people (100 in the training set, and 50 in the test set) who were given an injection of nerve growth factor into the right masseter muscle on day 0 and day 2 to induce prolonged jaw pain that lasted up to 4 weeks.
Participants were healthy adults recruited in Australia with a mean age of 25. They had no history of chronic pain or a neurological or psychiatric condition, and 84 participants (56%) were men.
The research aimed to determine whether individuals could be accurately classified as having high or low pain sensitivity based on baseline PAF and CME readings. The researchers used electroencephalography to assess PAF and transcranial magnetic stimulation with resulting evoked potentials to assess CME on day 0, day 2, and day 5.
The primary outcomes were jaw pain on chewing and yawning. Pain sensitivity was assessed twice daily from day 1 through day 30 through self-reported pain scores.
Seminowicz and colleagues used five machine learning models on the training set. Of these, the winning classifier was logistic regression. Including sex and pain catastrophizing as covariates did not improve model performance.
The study assessed healthy participants using an experimental pain model; results may not apply to other people or other circumstances, the researchers acknowledged.

Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow

Disclosures
This project was funded by the National Institutes of Health (NIH).Seminowicz and one co-author reported having a patent issued for peak alpha frequency through the University of Maryland in Baltimore. No other disclosures were reported.Shirvalkar reported relationships with the NIH, Medtronic, QuantalX, and a patent pending for closed-loop deep brain stimulation for chronic pain. Rozell reported personal fees from Motif Neurotech and a patent pending for a system to identify transitions in brain states for depression.

Primary Source
JAMA Neurology
Source Reference: Chowdhury NS, et al “Predicting individual pain sensitivity using a novel cortical biomarker signature” JAMA Neurol 2025; DOI: 10.1001/jamaneurol.2024.4857.

Secondary Source
JAMA Neurology
Source Reference: Shirvalkar P, Rozell CJ “Brain biomarkers for pain sensitivity” JAMA Neurol 2025; DOI: 10.1001/jamaneurol.2024.4743.

Please enable JavaScript to view the comments powered by Disqus.

LOS ANGELES — Clinicians working in advanced heart failure vented their frustrations about the shrinking number of device therapies left from round after round of FDA recalls. Could a changed regulatory climate under the Trump administration bring about more treatment options?
The question came up during an audience Q&A session at the Society of Thoracic Surgeons (STS) annual meeting. While panelists were generally hesitant to make predictions about politics, Richard Lee, MD, JD, MBA, of Augusta University Medical Center in Georgia, laid out how things could go two ways in the years ahead.
One is a push to move device development faster along in industry, with a higher tolerance for defects. On the other hand, the reduced government support for research funding, evident already, would suggest no economic support for medical device makers.
“I personally think it’s going to be both,” said Lee. “I could be wrong.”
A renewed appetite for innovation would bring some relief to the field of advanced heart failure in particular, which is now down to just one durable left ventricular assist device (LVAD) on the market, the HeartMate III. In 2021, the competing HeartWare ventricular assist device had been pulled for pump stop events, plus excess neurological events and mortality when compared with LVADs.
A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device design (31.4%), process control (16.1%), or component design or selection (7.3%).
At STS, physicians shared how they were navigating the various FDA recalls and the medicolegal implications of using devices under these recalls.
Courtney Maxey-Jones, MD, of CNY Medical Services in Baldwinsville, New York, recounted her experiences seeing device after device taken out of commission for various reasons when she could have still used them to save patient lives. In one instance, her hospital administrators had locked up all the Cardiohelp systems that were subject to a class I recall due to stiff hand cranks impeding an emergency drive.
Those were decisions made by “people who didn’t have to look at the patients that no longer had [the device] as an option,” Maxey-Jones lamented. “In order to be able to continue to provide high-level care to, frankly, the sickest of the sick patients, I’m not choosing a new prescription med. I’m deciding if I can give you mechanical circulatory support so that you don’t die in front of me.”
“If we’re going to continue to be the best advocates for our patients, we need to continue to insist on and invest in a diverse portfolio of mechanical support devices, which we can then match to our individual patient needs,” stressed Leora Yarboro, MD, of UVA Health in Charlottesville, Virginia.
“When something’s removed and not replaced with something that is also going to do the same thing for your patients, you really hope that you’re going to have some therapies for them. It’s our job … to make sure that patients who are supported with the device continue to be followed and supported as well, even if the device itself is no longer being manufactured,” she said.
So which devices are still okay to be used in clinical practice?
“Maybe we’re going to be sued for it, but I think it’s still reasonable to provide the best effort that you can … to save people’s lives with the tools that we have available,” said Yarboro.
“All technology has limitations, and it’s our shared responsibility to identify and report findings through our registry data … In this way, we can continue to be the best advocates for our patients, and remember that the goal behind reporting is not to have these life-saving devices be removed from the market, rather to ensure that the technology continues to evolve and to allow for informed decision-making by all,” she said.
Lee, a practicing lawyer, provided some reassuring data about the legalities of using medical devices under recall. In searching the national database, and consulting with lawyers who work with personal injury law, he could only identify two cases where a physician was named for failure to incorporate an action after receiving a recall notice — both got dismissed. “Right now, this is virgin territory,” he said.
What is more legally worrying is off-label use of drugs and devices, which he said he now avoids as much as he can.
Good communication with the patient and the patient’s family is key, according to Lee.
For example, the Impella 5.5 with SmartAssist is technically under class I recall and affected products are advised to be avoided unless no other product is available. As for Impella-assisted high-risk surgery, “I love it, and this is not an endorsement … I’m not going to stop doing it,” said Lee.
“I am not. I’m going to increase doing it, but now I’m going to tell every single patient ‘I’m doing this, they’re doing education for it, and you will have a risk … You can get a clot in the thing and it goes up to your head,'” he added.
If the patients say “no,” then he will back off on the procedure, he said.

Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures
Lee is a partner at Hochman and Lee, LLC.Maxey-Jones had no disclosures.Yarboro disclosed a prior speaker/honoraria relationship with Arthrex.

Please enable JavaScript to view the comments powered by Disqus.