Tag: United States

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Tiny HHS office tasked with protecting research participants’ safety is running on fumes

In 2021, the federal office charged with ensuring that the vast research enterprise bankrolled by the Department of Health and Human Services keeps study participants safe, received a report of a death by suicide involving a person enrolled in a study testing a treatment for depression and reduced mobility. 

Once the Office of Human Research Protections started looking into the death at the New York State Psychiatric Institute, it found problems that spread far beyond that one study, including failures in how the institute’s ethics board reviews proposed research. “We saw, holy smokes, this whole institution has issues,” said Lisa Buchanan, then director of the OHRP’s compliance division. The investigation became all-consuming. “It was probably 60-70% of our time,” she said.

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Open Letter: In Support of Mandatory Nucleic Acid Synthesis Screening and Recordkeeping

An open letter, In Support of Mandatory Nucleic Acid Synthesis Screening and Recordkeeping, published late on the evening of June 3, 2026, and signed by life sciences researchers, technologists, national security experts and former White House officials, is calling for mandatory screening of synthetic nucleic acids. This effort is significant because it highlights that screening is a rare point of consensus for a wide coalition of science and technology experts and is widely seen as both pro-AI and pro-safety.

From the CEOs of the major labs to AI skeptics and safety organizations to luminaries in the life sciences, public health, and national security, there is wide agreement that we need stronger screening guardrails. The letter calls on US lawmakers to codify mandatory nucleic acid synthesis screening, including recordkeeping, in order to combat the development of biological weapons at the scale of AI. The open letter reads as follows:

As life sciences researchers, builders of AI and biotechnology, and experts with a wide range of views on how to approach AI policy, we call on legislators to make screening of orders for synthetic nucleic acids—and the equipment needed to make them—mandatory. 
The ability to order synthetic DNA online has accelerated vaccine development, powered basic research, and made it possible for small teams to access capabilities that used to be confined to major institutions. Since the publication of protocols to reconstruct viruses from strands of DNA more than two decades ago, it has also been recognized as a point in the biotechnology supply chain where a bad actor could cause outsized harm. Recognizing the vulnerability, synthesis companies formed the International Gene Synthesis Consortium in 2009 to develop and implement voluntary safeguards against misuse.

While the issue is not new, the pace of progress in artificial intelligence is. AI systems now outperform PhD-level virologists on questions about highly technical laboratory procedures in their own domains of expertise. The evidence about what this means for present-day biosecurity threats is genuinely mixed, but the trend is hard to dispute. AI systems are improving rapidly, and alongside incredible benefits to science and medicine, there is a real possibility that the knowledge barriers which have historically prevented bad actors from obtaining biological weapons will meaningfully erode.

Support for screening does not depend on any particular view of AI; the biosecurity case has been recognized by scientists and governments for decades. Screening is also one of the best understood and least disruptive biosecurity measures available. It asks providers of synthesized DNA and manufacturers of synthesis machines to check synthesis requests for sequences of concern and to verify customer legitimacy before shipping orders. Providers should also record synthesis orders and sequence data to support legitimate biosecurity investigations, so that any threat that might evade initial screening can be traced back to its source — including when individual sequences would not raise concern in isolation. Awareness of traceability itself deters misuse.

Many of the largest and most responsible providers in the industry already screen and record orders voluntarily because it is well understood that they have an important role to play in maintaining public trust in and mitigating potential misuse of this important technology.

For these reasons, the undersigned support mandatory nucleic acid synthesis screening, including recordkeeping, in the United States.

Given the pace at which the underlying technology is changing, we believe the need is urgent. Congress should act this session, and we applaud the legislative efforts currently underway. To ensure a consistent national standard rather than a patchwork of conflicting laws, states should also consider implementing requirements based on existing federal and industry guidelines.

This is a rare moment of agreement across stakeholders that are often at odds. We hope policymakers will meet it with decisive action.

Sincerely,

You can find the full list of signatories and the letter here. I am a media consultant working with the two organizations that are the primary organizers of the letter: the Institute for Progress (IFP) and the Foundation for American Innovation (FAI). The best email contact regarding the open letter is letter@screendna.org.

Carrie Hutcheson is senior director of the Glen Echo Group in Washington, DC.  

 

The post Open Letter: In Support of Mandatory Nucleic Acid Synthesis Screening and Recordkeeping appeared first on GEN – Genetic Engineering and Biotechnology News.

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Experimental Adjuvant Could Strengthen Mucosal Immunity with Injectable Polio Vaccines

The injectable form of the polio vaccine has proven effective at preventing illness but it does not block the transmission of the virus as well as the oral version of the vaccine. That is because the virus is usually transmitted through contaminated food or water and is first exposed to the GI tract, where the oral vaccine induces a mucosal immune response. To date, several countries no longer use the oral vaccine because there is a small risk of infection. It is also possible for people who receive the injected polio vaccine to spread the virus even though they are asymptomatic. 

Now according to data from an Massachusetts Institute of Technology-led study, it may be possible to modify the injectable vaccine so that it can also promote a mucosal immune response. This way, the vaccine could support polio eradication efforts without the risks of the oral polio vaccine. Details are published in a new Science Advances paper titled “Am80-Lipid nanoparticles serve as an enteric mucosal adjuvant 3 following parenteral immunization with inactivated polio vaccine.”

In comments that shed some light on the thinking behind the work, Ana Jaklenec, PhD, a principal investigator in MIT’s Koch Institute for Integrative Cancer Research, stated that while “people who are vaccinated with the injectable vaccine are not getting sick” they may be helping spread the highly contagious virus. “Mucosal immunity could help lower that shedding and ideally eliminate it,” she said. 

Her team’s version of the vaccine comprises an injectable, inactivated polio vaccine delivered with a nanoparticle-based adjuvant that helps steer immune cells to the mucosal lining of the intestine. Digging into the details, Jaklenec and her team worked with a group at Harvard Medical School who have shown previously that using a derivative of vitamin A as a vaccine adjuvant can help stimulate immune cells to go into the GI tract. 

Though the adjuvant, known as Am80, generates a strong response, one challenge is that it needs to be injected for several days in a row, which is not feasible for most vaccine campaigns. To eliminate the need for repeated vaccinations, the scientists used a lipid nanoparticle (LNP) as a delivery vehicle that releases the adjuvant slowly over several days.

Armed with the updated vaccine, the scientists moved on to testing it in rats. For their tests, the scientists injected the standard inactivated polio vaccine along with a separate injection of Am80 encapsulated in LNPs. They also delivered boosters to the rats at four and eight weeks. 

Following injection, LNPs accumulate in the lymph nodes where they interact with B and T cells that are also exposed to the polio vaccine. The interaction stimulates the cells to produce two surface proteins that direct them to the GI tract. Additionally, the B cells produce IgA antibodies, which protect body surfaces from infection by coating the mucosal membranes. Lastly the rats produce IgG antibodies in the bloodstream, which are similar to the antibodies produced in response to the standard injected polio vaccine. 

Overall, in the rats, they found that administering the vaccine and adjuvant produced a two-fold increase in the type of antibodies needed for mucosal immunity compared to the inactivated vaccine alone. Essentially, “by adding Am80 to lipid nanoparticle as an adjuvant, we are combining the safety of IPV with an adjuvant that can produce the mucosal immunity that normally you can only get with OPV,” said Behnaz Eshaghi, PhD, a postdoctoral student at MIT and lead author of the paper. 

For their next steps, the scientists plan to test the improved vaccine in other large animal models where they will inject the vaccine and adjuvant mixed together. More broadly, Am80 and similar adjuvants could help scientists design improved vaccines for other pathogens that infect the GI tract or for diseases that infect the lungs or reproductive tract. 

The post Experimental Adjuvant Could Strengthen Mucosal Immunity with Injectable Polio Vaccines appeared first on GEN – Genetic Engineering and Biotechnology News.

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Mapping the neuroimaging landscape of inflammatory bowel disease: a bibliometric analysis and systematic scoping review

BackgroundInflammatory bowel disease (IBD) is recognized as a prototypical disorder of brain-gut interaction. Although neuroimaging research in this field has advanced rapidly in recent years, the findings remain fragmented across multiple disciplines, and a systematic integration of the literature is lacking.ObjectiveThis study presents the first integrated bibliometric analysis and literature review to map the landscape and evolving trends of neuroimaging research in IBD over the past two decades and to identify the knowledge base and research frontiers.MethodsWe conducted a systematic search of the Web of Science Core Collection and Scopus databases for IBD-related neuroimaging literature published between January 2000 and January 2026. Following the PRISMA guidelines, two independent reviewers screened titles, abstracts, and full texts. A total of 175 articles met the inclusion criteria. Data were extracted on study characteristics, neuroimaging modalities, and clinical findings. For the synthesis, we employed a dual approach: (1) a bibliometric analysis using VOSviewer, Biblioshiny, and CiteSpace to map publication trends, collaboration networks, and research hotspots; and (2) a structured literature review across five predefined dimensions: technical modalities, brain region–symptom associations, subtype differences, mechanistic pathways, and clinical translation.ResultsThe systematic search and selection process identified 175 articles for final synthesis. The field has entered a phase of rapid expansion since 2021, with China and the United States as core contributing countries. Emerging frontiers include the “brain-gut axis” and the “default mode network.” The literature synthesis indicates that: (1) brain alterations are predominantly localized within an emotional and interoceptive network (anterior cingulate cortex, insula, and amygdala), with abnormalities generally associated with abdominal pain, anxiety, and depression; and (2) Crohn’s disease and ulcerative colitis appear to exhibit distinguishable neuroimaging phenotypes, though direct comparative studies remain limited.ConclusionThis study systematically clarifies the knowledge structure of the IBD neuroimaging field, demonstrates that the available neuroimaging evidence is consistent with the brain-gut axis as a central theoretical framework, and identifies subtype-specific neural characteristics. Future efforts should prioritize large-sample multicenter validation, longitudinal designs capable of testing mechanistic hypotheses, and multimodal data integration to transition the field from descriptive observations toward clinically meaningful applications,though substantial barriers—including small sample sizes, methodological heterogeneity, and lack of standardization—must first be overcome.
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How courts are coping with a flood of AI-generated lawsuits

Most days in her chambers, Judge Maritza Braswell, a federal magistrate judge in Colorado, sifts through stacks of documents written by people without a lawyer. Many of them can’t afford to hire a lawyer, and others have cases too weak or too small to interest one. She reads each one carefully, mindful of how daunting it is to walk into the courtroom alone. 

Lately, like many judges across the US, she has seen a noticeable uptick in such filings. According to a new study that examined 4.5 million federal civil cases from 2005 to 2026, the share of lawsuits brought by self-represented people increased from 11% in 2022 to 16.8% in 2025. Within those cases, the number of filings made more than doubled compared to before 2023. 

Judge Braswell puts that jump down to AI. 

“I do correlate that to AI in part because I see AI use,” she says. As a tech-savvy judge who uses AI to vet court documents, she’s learned to recognize how large language models write. She can tell based on the prose and at times, hallucinated cases and fabricated quotes. 

“I’m also actually seeing better-drafted pleadings,” she says. 

But while AI appears to be expanding access to justice, it doesn’t seem to be improving people’s chances of winning. Judges are also starting to question what kinds of rights and responsibilities large language models should bear as they step into lawyers’ shoes, such as whether a chatbot has a duty to provide good advice, as a human lawyer does. And a growing number of lawmakers across the US are starting to grapple with who should pay the price when chatbots dish out bad legal advice. 

AI supercharges lawsuits

To test whether AI was driving the increase in lawsuits filed by people without a lawyer, the authors of the study, Anand Shah at MIT and Joshua Levy at USC, ran 1,600 randomly sampled court documents through Pangram, a commercial AI-text detector. The share flagged as containing AI-generated writing rose from 1% in 2023 to 18% in 2026. 

To Judge Braswell, that’s not necessarily a cause for concern. While the surge of AI-assisted filings might be adding to their workloads, she and many other judges find the cases easier to rule on because AI is helping people without legal training better articulate their arguments. 

Court documents written by people without lawyers are notoriously hard to decipher. Some arrive as handwritten scrawls bordering on gibberish that judges take a while to decode. However cryptic, judges are required to read them charitably.

These days, Judge Braswell has been churning through motions drafted by AI faster than the ones written by the litigants. “I have to be really careful because some of them contain hallucinations and errors, but I can generally understand what they’re arguing better with AI assistance from them than without it,” she says.

The clearer filings let Judge Braswell hear them better. “If I understand an argument a little bit better, I’m probably going to be able to help a little bit more.”

Online communities are springing up to trade self-help guides on using AI to sue. In December 2024, a viral Reddit post walked immigration applicants through suing the United States Citizenship and Immigration Services over delayed review of their applications: draft a writ of mandamus with Microsoft Copilot, pay a lawyer $150 to polish it, and file in the expedient District of Vermont. Cases filed by people without lawyers in Vermont rose from about 45 a year before 2022 to more than 1,100 in 2024. 

Even so, people without lawyers are far more likely to lose their case than people with lawyers, and that’s not changing even with the addition of AI, the study found. 

“It turns out that mounting a lawsuit is a complex, multifaceted task. Not all of it is just drafting text,” says Joshua Levy, a doctoral student at University of Southern California, who co-authored the study. 

Chatbot-client privilege

Judge William Garfinkel, a federal magistrate judge in Connecticut, has served on the bench for three decades, pondering all sorts of questions about lawyers’ relationship with their clients. Lately, he has been wondering whether people’s conversations with chatbots dispensing legal advice should be privileged, the way that their conversations with lawyers are. 

“You can make a good argument that … conversations with large language models like Claude or ChatGPT or Grok should deserve some protection,” he says.

Courts are starting to grapple with this question. In February, a federal court in Michigan ruled that a self-represented person’s conversations with ChatGPT to prepare her case were work product—legal work that is shielded from the opposing side.

The decision came on the same day that a federal court in New York held that documents that a criminal defendant generated using Claude were not privileged attorney-client conversations or work product. The Court argued that Claude is not an attorney and that a user has no “reasonable expectation of confidentiality in his communication” with Claude because AI companies could disclose user data to third parties. 

In March, Judge Braswell also ruled that a self-represented person’s use of a chatbot should stay off limits. “It is true that AI systems like ChatGPT, Claude, Gemini, and others … collect user data for training and other purposes. But … that does not eliminate all expectations of privacy,” she wrote. Courts have since remained split on the issue.

Malpractice without a pulse

Some judges are also wondering whether a chatbot, like a lawyer, has a duty to provide good legal advice. Judge Allison Goddard, a federal magistrate judge in California, has noticed that people without lawyers often get the wrong advice from ChatGPT when trying to assess the value of their case during settlement negotiations. In one case, a plaintiff who slipped and fell in a store asked for $700,000 from the store, which was wildly more than the case was worth.

“Where are you getting the idea that you’re getting $700,000? Did you go to ChatGPT?” Judge Goddard asked. “Well…” the plaintiff mumbled. She then walked them through the law to explain why ChatGPT was wrong and suggested a lower amount. “It’s like Dr. Google went to law school,” she says.

Then there’s the question of who’s liable when a chatbot gives bad legal advice. In March, Nippon Life Insurance Company sued OpenAI alleging that ChatGPT practiced law without a license and helped a woman reopen a lawsuit that was already settled, flooding the court with frivolous filings. “ChatGPT is not an attorney,” the lawsuit said. 

In May, OpenAI asked the court to dismiss the case, arguing that ChatGPT does not practice law. “ChatGPT is not a person and neither has nor uses any degree of legal ​knowledge or skill,” OpenAI said in its filing. The case is still pending before the court.

States have started to weigh legislation that would hold AI companies liable when their chatbots offer bad legal advice. New York introduced a bill in March that would bar chatbots from impersonating lawyers, even if they notify ​users that they are interacting with chatbots. In Congress, a series of bills have been proposed to ban chatbots from posing as lawyers, doctors, and other licensed professionals. The bills have yet to gain traction.

For now, people will continue turning to AI to be their lawyer. For many of them, the rewards outweigh the risks. Not long ago, when Judge Braswell asked a self-represented litigant why they wanted a particular piece of evidence, they mumbled timidly. Now, they answer her questions confidently, having rehearsed with a chatbot. 

“This is a really tough system to navigate. With AI, though, it gets a little less complex,” she says.

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What happens at a longevity festival?

The longevity movement is often associated with people that have enough money for a thousand lifetimes — and want to live long enough to spend it all. When my STAT colleague Sarah Todd recently attended the longevity festival known as Vitalist Bay, however, she discovered that the movement isn’t all wealthy Silicon Valley tech bros. 

In this week’s STATus Report, I chat with Sarah about her trip to this California conference, the science of longevity, what the heck a “bodyoid” is, and more. 

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Opinion: Grail’s multi-cancer early detection trial was negative. But as an oncologist, I see more to this story

At least 12 of my colleagues boarded planes to the American Society of Clinical Oncology conference in Chicago last week to hear Charles Swanton of the Francis Crick Institute in London share results from the world’s first randomized trial on a multi-cancer early detection test.

The trial — a partnership between the U.K. National Health Service and Grail, which makes the Galleri MCED test — randomized 143,000 average English adults aged 50-77 to receive either usual care or MCED testing. The primary endpoint was reduction of stage 3 and 4 cancers across all cancer types.

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STAT+: After hospitals, patients get a turn to bring AI into the doctor’s office

Patients are getting used to being recorded in the doctor’s office. More than a quarter of U.S. practices now use AI-based listening tools called ambient scribes, which capture visits in real time and draft clinical notes for clinicians to enter into patients’ medical records. 

But what happens when it’s the patient doing the recording?

Nearly every patient now has a recording device in their pocket, and commercial large language models have made it easier than ever for them to transcribe and interpret audio files. A growing number of consumer apps — with names like VisitRecall, Advoca Health, and AlignCare — are using AI to do just that, delivering summaries and action items for patients after the fact. One called Kin Health, with backing from the co-founder of GoodRx, announced a $9 million seed round in May. 

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CAR T-Cell Therapy Expands Access to Kidney Transplants 

CAR T-cell therapy has enabled two patients who had been waiting for years for a kidney transplantation to find a match. Published today in the New England Journal of Medicine, preliminary results from a Phase I clinical trial show that CAR T therapy can significantly increase the chances of a match for people whose immune system would otherwise reject over 99% of kidneys available for transplant. 

“This is the first demonstration that CAR T cells can be used not only to treat cancer, but also to help patients who previously had no opportunity to receive a compatible donor kidney,” said Ali Naji, MD, PhD, professor of surgery at the University of Pennsylvania and principal investigator of the study. “For patients who have spent years on the kidney transplant waiting list, this approach could be transformative.”

More than 91,000 people in the U.S. are currently waiting for a kidney transplant. Physicians assess each patient’s likelihood of finding a compatible donor using the calculated panel reactive antibody (cPRA) score, which measures how broadly the immune system is primed to attack foreign tissues. For instance, a cPRA score of 90% means the patient is expected to reject 90% of kidneys available for transplant, leaving only a small pool of potential matches available to them. 

The ongoing CTOT-46 clinical trial is recruiting kidney transplant candidates with a cPRA score of 99.5% or higher who have been waiting for a kidney transplant for at least one year. Although the study will continue until up to 20 highly sensitized candidates have been recruited, preliminary results from the first two patients enrolled show promise for this innovative approach. 

Both participants were treated with a dual CAR T therapy designed to remove the immune cells responsible for making antibodies that lead to organ rejection after a kidney transplant. The CAR T cells are engineered to target the CD19 and BCMA proteins, leading to the depletion of memory B cells and antibody-producing plasma cells, respectively. This strategy significantly reduced the levels of circulating antibodies produced by these cells, enabling both patients to receive kidneys from donors that would have previously been incompatible.

One of the patients had been diagnosed with focal glomerulosclerosis at age 14, leading to kidney failure at a young age. His cPRA score had reached nearly 100% after his immune system rejected a second kidney transplant, making a third transplantation next to impossible. After years of waiting for an extremely unlikely match, the CAR T cells lowered his antibody levels enough to find a match within months.

Importantly, the depletion of immune cells was temporary, and the population of B cells and plasma cells returned to normal levels over time. Neither of the patients has shown signs of organ rejection or antibody rebound months after transplantation. Additionally, no cases of severe cytokine release syndrome or neurotoxicity were reported—two common complications of CAR T-cell therapy.

“In this early trial, the CAR T-cell treatment was tolerated well, with no severe side effects, and the immune system began to recover as expected,” said Robert Montgomery, MD, PhD, chair of the department of surgery at NYU Grossman School of Medicine and director of the NYU Langone Transplant Institute. “This early success reflects what cell therapy can do for transplant medicine and opens up new options for patients that could save thousands more lives every year.”

The post CAR T-Cell Therapy Expands Access to Kidney Transplants  appeared first on Inside Precision Medicine.

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STAT+: HaloMD faces lawsuit alleging No Surprises Act middleman used ‘sham letter,’ misleading data

A fourth major health insurer is suing HaloMD over its use of the No Surprises Act’s arbitration process, arguing that the middleman deceived arbitrators by sending them a “sham letter” and misleading price data. 

Highmark Health, a Pennsylvania-based Blue Cross Blue Shield licensee with over 7 million members, claims in a complaint filed June 1 in U.S. District Court in Western Pennsylvania that HaloMD and one of its clients, a neuromonitoring provider called Bromedicon, submitted more than 450 ineligible disputes with the company and won more than $3.9 million. Like the three Blue Cross plans before it, Highmark wants those awards tossed and its money returned.

“Defendants’ scheme is not a good faith attempt to obtain fair reimbursement,” Highmark’s complaint says. “It is a deliberate effort to wrongfully extract inflated payments from Highmark.” 

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