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Wednesday, April 16, 2025

Multiplication, Biden-Style: School Bias Cases Doubled

 by James Varney via RealClearInvestigations,

While limiting strings-attached grants and curbing federal regulation, President Trump’s efforts to dismantle the Department of Education also take aim at a key tool bureaucrats use to oversee schools in all 50 states: civil rights investigations.

Probes handled by the department’s Office for Civil Rights (OCR) against public schools, colleges and universities roughly doubled during the Biden administration, topping 20,000 last year. Investigations by hundreds of OCR lawyers and staff members – and responses to them by untold numbers of school officials and administrators – touched on everything from allegations of sexual violence and disability accommodations to website compatibility. 

Defenders of the office say it has been an invaluable protector of civil rights for America’s nearly 70 million students. They say eliminating or even downsizing the office, which has already begun, would kneecap thousands of ongoing investigations while abolishing a prime instrument of justice. 

This reckless action strips students of vital resources and tears down statutorily mandated functions that are essential to addressing racial and economic inequality in education,” the ACLU declared last month. Trump, it said, has put “millions of students’ education and civil rights at risk.”

Advocates for handicapped students, who until recent years accounted for half of all complaints, are concerned they might get short shrift in the Trump administration and have gone to court to block cuts. “We have many members who file complaints, and it has left many of them in limbo, or distraught, thinking there will be no accountability,” said Selene A. Almazan, legal director of the Council of Parent Attorneys and Advocates, plaintiffs in a suit filed March 14. 

But backers of Trump’s effort to eliminate the Department of Education counter that the Office for Civil Rights is a symbol of how the federal government has expanded its reach into what they describe as chiefly local matters. They say its investigative arm has been designed to make it as easy as possible for the department to maximize its influence and oversight through investigations. 

A complainant does not need a personal connection to a school. Indeed, petitioners don’t even have to live in the same state, and legal standing is not a factor. They do not even need to identify themselves. They are not required to try to resolve their problems at the local level before notifying the feds – though many do. Consequently, the office’s operations sometimes function as a nationwide anonymous sounding board rather than a source of last resort, a place where anyone can make a federal case out of any slight, real or perceived.

Although OCR probes include many serious allegations, the system’s structure means the number of cases can be inflated through duplication, serial filers and ambitious bureaucrats.

The numbers aren’t really what they first appear,” said Teresa R. Manning, policy director at the National Association of Scholars, a conservative counterweight in higher education to the liberal American Association of University Professors. “A lot of this was by design. If they didn’t have complaints, they wouldn’t have jobs, so a lot of federal bureaucrats and campus officers want any grievance to become a federal case.”

The numbers themselves are unclear. Neither the Department of Education nor its Office for Civil Rights responded to multiple requests for comment, and a listed phone number is no longer manned daily; voice messages left there were not returned. But it appears the administration has laid off some 240 people in the OCR, shuttering at least six of its 12 regional offices. Currently, eight of 22 “key staff” positions there are vacant, according to its website.

When Trump and Secretary of Education Linda McMahon first announced layoffs in February, reports mentioned 12,000 active investigations listed on the OCR database, which was last updated on Jan. 14. Last month, Sen. Bernie Sanders announced his own report on the office, claiming 6,800 cases would be shortchanged by the layoffs. 

But no matter which total is used, the claim that U.S. schools are teeming with incidents of overt racism or sexism, or bias against handicapped students, is misleading, according to experts familiar with the OCR and its work. 

In theory, every complaint is reviewed to determine if it constitutes discrimination on the basis of race (“Title VI”), sex (“Title IX”), or disability. If so, the Office for Civil Rights can open an investigation, or its attorneys can allege that there are “systemic” violations and trigger much broader investigations.

Such initiatives were highlighted in a glossy report the office released on Jan. 16, four days before Trump’s inauguration. The office appears to have published six such “special reports” since 2016, with half of those during Biden’s term. Two of them – the first and another in 2021 – dealt with alleged “racial disparities” or “equity” in school discipline.

This looks like a more proactive OCR following the age-old practice of boosting the cases on its books and then insisting it needs more funding, said Jim Blew, a co-founder of the Defense of Freedom Institute and a former assistant secretary of education in Trump’s first term.

Skepticism is legitimate, because by declaring something is ‘systemic,’ then rather than resolve that one issue they can turn it into a federal case,” Blew said. “And if you’re going to interpret the discrimination on much different and broader levels than ever before, that’s going to increase the number of complaints, too.” 

RealClearInvestigations found that, despite claims that cuts to OCR will impede “prompt” action or justice for filers, the office did not always handle complaints promptly. Among the 12,000 ongoing investigations listed in the OCR database – half of which involved disability complaints – RCI found active investigations into alleged incidents that occurred in 2016 or 2017, long after any students at the schools in question would have departed. Many alleged incidents also triggered more than one investigation, meaning the “thousands” are fewer than they first appear.

The investigations can take years. Alabama A&M University, for example, is under investigation for “sexual violence” that allegedly occurred on Aug. 24, 2016. The university did not respond to requests for comments on this alleged incident or general compliance with OCR.

Similarly, on Aug. 2, 2017, an alleged incident in Mississippi’s Greene County School District sparked two investigations, one for racial harassment and another for “retaliation” that remain active, according to OCR’s website.

Also, totals were swollen by one unnamed individual. For example, in 2022 when OCR received 9,948 complaints of Title IX violations, nearly three out of four – 7,339 – came from this person. That same individual slipped a bit the following year, accounting for only 69% of the 5,590 complaints. RCI asked several people familiar with Office of Civil Rights work who this person might be, but none said they knew.

The number of complaints skyrocketed during the Biden administration, doubling the average that had held for more than a decade, records show. Last April, Biden regulators sought a radical expansion of Title IX sex discrimination protection to cover things like “gender identity.” That attempt was later blocked by the courts.  

Through President Obama’s two terms and Trump’s first term, the office received just under 10,000 complaints annually. In 2022, however, that figure shot up to a record 18,804 and did not stop climbing. It jumped 18% in 2023 before topping 20,000 complaints for the first time in 2024, according to OCR.

It’s not exactly clear what accounted for the big increases, according to experts. But the usual breakdown of classification of complaints changed. Instead of disability complaints comprising more than half of the total OCR received, 42% of those filed in 2023 concerned sexual discrimination, while disability complaints fell to a bit more than a third, according to the office’s figures.

Office for Civil Rights attorneys can launch investigations, or encourage schools to do so, via the well-known “Dear Colleague” letter that alerts administrators to how regulators plan to interpret federal laws. It was just such a “Dear Colleague” letter in 2011 from Catherine Lhamon, who headed the Office for Civil Rights under Obama and Biden, that urged schools to use the lowest possible level of evidence in sexual harassment or assault cases, to make it easier for people to request a remedy to perceived injustice.

If you’re going to interpret the discrimination in much different and broader terms than ever before then you’re going to increase complaints,” Blew said. “It should be obvious there are certain interests that care about padding their Office of Civil Rights numbers.”

'Administrative Bloat'

In the face of rising Office for Civil Rights investigations, letters and complaints, schools have been forced to add more layers of administrators and attorneys. Those offices also grew during Biden’s term, when an emphasis on “diversity, equity and inclusion” departments and offices swelled higher education payrolls.

“It has led to administrative bloat, too, as tuition goes to deanlets and bureaucrats,” Manning said. “They often partner together with other entities on campus, and you have many bureaucrats who feed complaints.” 

In its January report, OCR reported that it had received 71,385 complaints during Biden’s term and had resolved 56,383 of them. But the backlog of complaints has grown, and in the 13 years covered by the report it was only during Trump’s first term that the office reported resolving more complaints than it received. At least one person who has filed numerous complaints with the OCR suspects that some of the backlog results from an unwillingness to tackle cases that do not fit progressive orthodoxy.

Mark Perry, a professor emeritus at the University of Michigan, who specializes in complaints challenging race- and gender-based scholarships, fellowships and other programs, said OCR has opened 423 investigations into his complaints since he started filing them in 2019. 

I currently have nearly 300 complaints backlogged at OCR, some going back to 2019 and 2020 that have either never made it through the evaluation stage to being opened for investigation and others opened for investigation back in 2019, 2020, and 2021, etc. that have never been resolved,” he said. “Now it's possible I'm being targeted and slow-walked for being a repeat filer for complaints alleging discrimination against men and whites.”

Perry based that belief, in part, on a handwritten letter he received from an OCR employee in its Chicago branch in September 2023 in response to a Chronicle of Higher Education article about Perry’s filings. “OCR has no impetus, sadly, to advance your cases, total failure in HQ,” the letter said. “Your cases just sit with no activity.”

The delays are especially odd, in Perry’s opinion, given that he is a professional who accompanies his complaints with printed evidence of the specific grant or program he thinks should be curtailed or made available to all students. “My complaints are simple; they should only take a couple of months,” he told RCI.

Another more recent, consistent filer is the Equal Protection Project, launched by conservative Cornell Law School Professor William Jacobson, who runs the Legal Insurrection website. In 2025, the project has averaged an OCR complaint a week, and has filed 70 complaints since it began in February 2023.

Like Perry's, the project’s focus is on clear violations of the plain language of statues, Jacobson said. On April 1, the project filed a complaint against the Pennsylvania College of Technology, an affiliate of Pennsylvania State University, for 12 scholarships that allegedly “discriminate on the basis of race, color, national origin, and/or sex in violation of Title VI and Title IX, respectively.”

For now, it’s unclear what will happen to the thousands of investigations on the office’s books, or to future complaints like disability grievances filed by Almazan’s group. The laws require a direct interference with a student’s education to validate a complaint, a distinction drawn more by the courts than administrators and bureaucrats who give themselves wide latitude to pursue their own enforcement goals, experts said.

“Biden and the Democrats tend to tinker with the language, creating ‘subjective’ offenses that are a moving target and raise due-process concerns,” Manning said. “The courts have tried to rein it in.”

Even as it appears intent on limiting the Education Department's reach, the Trump administration has also signaled that it will not completely surrender the use of federal power to influence local schools. It has vowed  to root out antisemitism on college campuses, biological men competing against women in sports, and diversity, equity and inclusion programs the administration says violate the clear letter of discrimination laws.

On April 7, McMahon announced a special investigative office, staffed by the Education and Justice departments, to enforce “Title IX to protect female students and athletes.”

https://www.zerohedge.com/political/multiplication-biden-style-school-bias-cases-doubled

'CDC Advisors Weigh Switch to Risk-Based COVID Vaccination'

 The CDC's vaccine advisors are considering options that would narrow the recommendations for the fall COVID vaccine to only include groups at higher risk for severe illness.

The news came at a Tuesday meeting of the Advisory Committee on Immunization Practices (ACIP), the first of a 2-day session that was originally scheduled for February but abruptly postponedopens in a new tab or window by HHS.

Seasonal COVID shots are currently recommended for everyone 6 months and older, but CDC's Lakshmi Panagiotakopoulos, MD, MPH, presented findings from a recent poll of the ACIP COVID-19 Work Groupopens in a new tab or window showing that 76% of its members supported a non-universal (risk-based) recommendation for the 2025-2026 respiratory virus season.

"I guess I am surprised we're considering a risk-based recommendation," said ACIP member Denise Jamieson, MD, MPH, of the University of Iowa's medical school.

She worried it will be harder to implement, and may cause more headaches for patients who want to get shots and have them covered by insurance.

According to estimates, 74% of U.S. adults have at least one condition placing them at higher risk for severe illness, whether that be age, a chronic illness, or an immune-compromising condition.

In the April 3 poll on non-universal policy options, 84% of the work group members supported COVID vaccine recommendations for specific conditions and exposures, 84% supported a universal recommendation for certain age groups (e.g., those 65 and up), and 89% said they supported having the vaccines available for anyone wanting protection.

Jamie Loehr, MD, of Cayuga Family Medicine in Itasca, New York, said he is happy the committee is considering a risk-based recommendation but also worried about feasibility and the message it would send.

"COVID is still a fairly dangerous disease and very, very common," he said. "We are not talking about 10 cases of mpox. We are talking about thousands of hospitalizations and deaths."

Data presented by CDC officials at the meeting showed the waning severity of the coronavirus pandemic. For example, COVID-19 dropped from the third leading cause of death among U.S. adults in 2021 to the 12th spot in 2023. And hospitalization rates fell from a peak of about 500 per 100,000 population in 2020-2021 and 2021-2022 down to about 60 per 100,000 in the 2024-2025 season.

From October 2024 to March 2025, children and adolescents comprised about 4% of COVID-related hospitalizations, with the highest rates among those younger than 6 months of age. More than half (59%) of those hospitalized had at least one underlying medical condition.

ACIP member Charlotte Moser, MD, of Children's Hospital of Philadelphia, said she favors the idea of a risk-based approach to COVID-19 vaccination. "I'm glad we're exploring that, [but] we need to keep the youngest of children on our radar because they represent a large group that's susceptible to the virus every year," she said. "If we can vaccinate those kids, we may be able to decrease the under 1-year-old hospitalization rate, and we may also protect them against long COVID."

Only 23% of adults and 13% of children received the 2024-2025 COVID shot, according to CDC dataopens in a new tab or window.

Among adults, vaccine effectiveness (VE) estimates for 2024-2025opens in a new tab or window ranged from 30% to 33% against COVID-associated emergency department visits or urgent care encounters. VE against associated hospitalizations among immunocompetent adults age 65 and older ranged from 42% to 48%, while the rate for their immunocompromised counterparts was 40%.

"VE should be interpreted as the added benefit of 2024-2025 COVID-19 vaccination in a population with high levels of infection-induced immunity, vaccine-induced immunity, or both," said Ruth Link-Gelles, PhD, MPH, of the CDC.

A vote on risk-based recommendations could come at the next committee meeting, scheduled for June.

ACIP members on Tuesday also heard details about the recently approvedopens in a new tab or window FluMist for self- or caregiver administration, expected to be available for the 2025-2026 influenza season. A vote on the vaccine was originally scheduled for the February meeting but removed from the April agenda.

Following a recent studyopens in a new tab or window suggesting the latest flu shot was associated with a higher rate of infections among healthcare workers, CDC officials presented dataopens in a new tab or window showing that the 2024-2025 vaccine had a VE in children ranging from 32% to 60% in outpatient settings and 63% to 78% in inpatient settings.

In comparison, VE among adults was slightly lower, at 36% to 54% in outpatient settings and 41% to 55% in inpatient settings.

"These estimates show that influenza vaccine reduced the risk for medically attended influenza outpatient visits and hospitalizations among children and adolescents and adults across 23 U.S. states," said CDC's Aaron Frutos, PhD, MPH.

https://www.medpagetoday.com/meetingcoverage/acip/115147

< 1 in 5 Medicare Enrollees Received Medication to Treat Their Opioid Use Disorder

 

Why OIG Did This Review

  • Combatting the overdose crisis continues to be a National priority.
  • As a payor, CMS plays an important role in ensuring that Medicare enrollees have access to medications and services for the treatment of opioid use disorder and to opioid overdose-reversal drugs.
  • This report provides data to help CMS and other decision makers target efforts to further combat the overdose crisis.

What OIG Found

  • Opioid overdoses among Medicare enrollees increased slightly in 2023 to 53,000.
  • With the buprenorphine waiver repealed, more providers ordered buprenorphine for Medicare enrollees in 2023 than in 2022.
  • Despite the increase in the number of providers ordering buprenorphine, fewer than one in five Medicare enrollees received any medication to treat their opioid use disorder.
  • Differences persist among enrollees receiving medication for their opioid use disorder, including by State; three States—Florida, Texas, and Nevada—had particularly low percentages of enrollees receiving medication.
  • More than 750,000 Medicare enrollees received opioid overdose-reversal drugs through Part D in 2023, a record high. Virtually all received naloxone.
  • However, with the most commonly dispensed form of naloxone now available over the counter, Medicare enrollees are losing Part D coverage of this form of naloxone, which could lead to higher out-of-pocket costs.

What OIG Concludes

These findings show a continued need for CMS to work to ensure access to both medications for opioid use disorder and opioid overdose-reversal drugs. OIG encourages CMS to implement recommendations we previously made related to these topics.

https://oig.hhs.gov/reports/all/2025/fewer-than-one-in-five-medicare-enrollees-received-medication-to-treat-their-opioid-use-disorder/

Modifiable risk factors for stroke, dementia and late-life depression

 

Jasper Senff1,2,3,4,5,
http://orcid.org/0000-0003-3204-0309Reinier Willem Pieter Tack1,2,3,4,5,
Akashleena Mallick1,2,3,4,
Leidys Gutierrez-Martinez1,2,3,4,
Jonathan Duskin1,2,3,4,
Tamara N Kimball1,2,3,4,6,
Benjamin Y Q Tan1,2,3,4,7,
Zeina N Chemali1,2,8,
Amy Newhouse1,9,
Christina Kourkoulis1,2,3,4,
Cyprien Rivier10,11,
Guido J Falcone10,11,
Kevin N Sheth10,11,
Ronald M Lazar12,
Sarah Ibrahim13,14,15,16,17,
Aleksandra Pikula14,15,16,17,
Rudolph E Tanzi1,
Gregory L Fricchione8,
Hens Bart Brouwers5,
Gabriel J E Rinkel5,
Nirupama Yechoor1,2,3,4,
Jonathan Rosand1,2,3,4,
Christopher D Anderson1,2,3,4,6,
Sanjula D Singh1,2,3,4

Abstract

Background At least 60% of stroke, 40% of dementia and 35% of late-life depression (LLD) are attributable to modifiable risk factors, with great overlap due to shared pathophysiology. This study aims to systematically identify overlapping risk factors for these diseases and calculate their relative impact on a composite outcome.

Methods A systematic literature review was performed in PubMed, Embase and PsycInfo, between January 2000 and September 2023. We included meta-analyses reporting effect sizes of modifiable risk factors on the incidence of stroke, dementia and/or LLD. The most relevant meta-analyses were selected, and disability-adjusted life year (DALY) weighted beta (β)-coefficients were calculated for a composite outcome. The Î²-coefficients were normalised to assess relative impact.

Results Our search yielded 182 meta-analyses meeting the inclusion criteria, of which 59 were selected to calculate DALY-weighted risk factors for a composite outcome. Identified risk factors included alcohol (normalised Î²-coefficient highest category: −34), blood pressure (130), body mass index (70), fasting plasma glucose (94), total cholesterol (22), leisure time cognitive activity (−91), depressive symptoms (57), diet (51), hearing loss (60), kidney function (101), pain (42), physical activity (−56), purpose in life (−50), sleep (76), smoking (91), social engagement (53) and stress (55).

Conclusions This study identified overlapping modifiable risk factors and calculated the relative impact of these factors on the risk of a composite outcome of stroke, dementia and LLD. These findings could guide preventative strategies and serve as an empirical foundation for future development of tools that can empower people to reduce their risk of these diseases.

https://jnnp.bmj.com/content/early/2025/03/21/jnnp-2024-334925

Cognitive Behavior Therapy for Mental Disorders in Adults

 Pim Cuijpers, PhD1,2,3Mathias Harrer, MSc1Clara Miguel, MSc1et al


doi:10.1001/jamapsychiatry.2025.0482


Key Points

Question  Is cognitive behavior therapy (CBT) associated with reductions in mental disorders in adults compared with controls?

Findings  In this series of uniform meta-analyses of 375 trials comparing CBT and controls, CBT was associated with significant reductions in mental health problems, with small effect sizes for bipolar and psychotic disorders; large effect sizes for major depression, panic disorder, social anxiety disorder, generalized anxiety disorder, bulimia nervosa, binge eating disorder, and obsessive-compulsive disorder; and very large effect sizes for PTSD and specific phobia.

Meaning  The evidence supports CBT as a first-line treatment for many mental disorders, although the quality of the evidence is limited.

Abstract

Importance  Cognitive behavior therapy (CBT) is a first-line treatment for most mental disorders. However, no meta-analytic study has yet integrated the results of randomized clinical trials on CBT across different disorders, using uniform methodologies and providing a complete overview of the field.

Objective  To examine the effect sizes of CBT for 4 anxiety disorders, 2 eating disorders, major depression, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and psychotic and bipolar disorders on symptoms of the respective disorders using uniform methodologies for data extraction, risk of bias (RoB) assessment, and meta-analytic techniques.

Data Sources  Major bibliographical databases (PubMed, PsycINFO, and Embase for all disorders) were searched up to January 1, 2024, for each disorder separately. Data analysis was performed from August 2024 to January 2025.

Study Selection  Randomized clinical trials comparing CBT with inactive control conditions in adults with 1 of the mental disorders established through a clinical interview were included.

Data Extraction and Synthesis  Basic characteristics of patients, CBT, and studies were extracted. RoB was assessed with the Cochrane RoB tool 2. Meta-analyses were conducted using random-effects models.

Main Outcomes and Measures  The primary outcome was the standardized mean difference (Hedges g) indicating the difference between CBT and controls at posttreatment on symptoms of the respective disorders.

Results  A total of 375 trials (423 comparisons) between CBT and controls were included among 32 968 patients. The overall mean (SD) patient age was 43.4 (13.7) years, and the mean (SD) proportion of women was 0.68 (0.24). Effect sizes for CBT compared to all control conditions (g) were lower than 0.5 for bipolar and psychotic disorder; between 0.5 and 1.0 for panic, social anxiety, and generalized anxiety disorders, bulimia nervosa, binge eating disorders, depression, and OCD; and larger than 1.0 for PTSD and specific phobias (range of effect sizes: 0.31 for bipolar disorder to 1.27 for PTSD). Large effect sizes (g > 0.94) were observed in waitlist-controlled trials, a control condition mostly used in anxiety and eating disorders, PTSD, and OCD. Trials using care as usual showed more modest effect sizes (0.22-1.13). Study dropout rates within the CBT conditions ranged from 8% for specific phobia to 24% for PTSD.

Conclusions and Relevance  In this unified series of meta-analyses, CBT was probably effective in the treatment of mental disorders, including major depression, anxiety disorders, PTSD, OCD, and eating disorders, and possibly effective in psychotic and bipolar disorders. However, the effect sizes depended on the type of control condition.

https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2832696

After delay, Alzheimer's drug Leqembi gets green light in EU

 The European Commission has approved Eisai and Biogen's Leqembi for a subset of patients with early-stage Alzheimer's disease, setting it up to become the first amyloid-targeting drug to reach the EU market.

As expected, there are restrictions on the use of Leqembi (lecanemab), which has been cleared for patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease who have only one or no copy of the ApoE4 genetic variant.

The EMA's human medicines committee, the CHMP, recommended against the approval of Leqembi in July 2024 on the grounds that its modest efficacy was outweighed by potentially serious side effects. That decision came despite prior approvals for Leqembi in the US, China, and Japan, and ahead of a go-ahead in the UK.

Patients with only one or no copy of ApoE4 are less likely to experience so-called ARIA side effects, like brain swelling and bleeding, associated with amyloid-targeting drugs, than people with two ApoE4 copies.

The CHMP subsequently changed its view and backed approval with the restricted label, although, the process was held up by a fresh safety review that kicked off in January and has been formally brought to a close with the Commission's decision to approve Leqembi – more than two years after Eisai and Biogen first filed their application.

In a statement, the Commission said that the assessment "concluded that the benefits of this medicine outweighed the risks in a particular population of patients with such disease and as long as risk minimisation measures are applied."

Eisai and Biogen said that Leqembi has become the first therapy that addresses an underlying disease mechanism in Alzheimer's, in contrast to previously approved drugs that boost neurotransmitters in the brain and temporarily prop up its functioning.

A rival amyloid therapy from Eli Lilly – Kisunla (donanemab) – was rejected by the CHMP in March, even though the company proposed restricting its label to include only people with no ApoE4 gene copies. That decision has now gone to appeal.

According to Eisai's chief executive, Haruo Naito, the company is "working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for lecanemab as soon as possible."

The Japanese drugmaker is taking the lead on Leqembi's development and regulatory submissions globally, with both companies co-promoting Leqembi across Europe other than Nordic countries, where it will be co-promoted by Eisai and BioArctic.

The EU approval comes after Eisai and Biogen were given approval for a new once-monthly intravenous maintenance dose of Leqembi in the US, after a biweekly IV initial induction course, that would reduce the number of visits needed to an infusion clinic.

The two companies are also hoping to get the go-ahead later this year for a new subcutaneous autoinjector formulation that could be administered at home.

Sales growth for the drug has proven to be sluggish, although, Eisai has predicted it will cross the $1 billion threshold in fiscal 2027, which ends in March 2028.

https://pharmaphorum.com/news/after-delay-alzheimers-drug-leqembi-gets-green-light-eu

J&J expecting $400m hit from tariffs in 2025

 Johnson & Johnson has said it expects to see a $400 million financial hit from President Trump's tariffs, which will be felt mainly in its medtech division, but acknowledged there is still a lot of uncertainty about their impact.

On its first-quarter results call, J&J executives said the company expects to exceed its revenue guidance for full-year 2025 and meet its earnings forecast, taking into account the tariff programmes that have been put in place at the moment.

Chief financial officer Joe Walk said: "I don't want to be cavalier about that. It's obvious the programme has been phased in as a partial year, and then you have mostly this being captured as cost of goods. It's going to sit on the balance sheet in inventory and be relieved to the [profit and loss] in future periods."

Its $400 million estimate includes the impact of retaliatory levies on products entering China, as well as rates on aluminium and steel, but excludes possible tariffs on imports of pharmaceuticals that are currently exempted, but now being considered by the US government.

Chief executive Joaquin Duato warned that those tariffs – if implemented – could raise the risk of some medicines becoming unavailable, noting: "There's a reason […] why pharmaceutical tariffs are zero. It's because tariffs can create disruptions in the supply chain, leading to shortages."

Trump is adamant that the policy is directed at ramping up the domestic production of pharmaceuticals and reducing the US' reliance on supplies from overseas and – while J&J has agreed to invest more than $55 billion in the US to help achieve that goal – Duato has reservations about the strategy.

"If what you want is to build manufacturing capacity in the US, both in medtech and in pharmaceuticals, the most effective answer is not tariffs, but tax policy," he told analysts on the call.

Later, he added: "I think it's also important that companies in healthcare partner with the administration to look to mitigate some of the vulnerabilities that exist today in our […] supply chain so as to avoid any continuity of supply effect."

J&J said first-quarter revenues came in at $21.9 billion, up 2.4% on the same period of 2024, which was a little above analyst expectations. It is expecting full-year revenues of $91.6 to $92.4 billion, a slight increase on its earlier projections.

Among its forecasts for the year are a $700 million contribution from recently acquired schizophrenia therapy Caplyta (lumateperone), a strong increase in sales of depression drug Spravato (esketamine) to between $3 billion and $3.5 billion, and turnover of its lung cancer combination Rybrevant (amivantamab) and Lazcluze (lazertinib) to come in at least double earlier projections of $1.8 billion.

https://pharmaphorum.com/news/jj-expecting-400m-hit-tariffs-2025