FDA-Approved Artificial Blood Vessel Stirs Concerns

The F.D.A. approved an artificial vessel to restore blood flow in patients, despite its own scientists flagging questionable study results and potentially fatal ruptures of the product.When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show.Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in an article in JAMA Surgery.At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.When a patient’s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.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.

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‘Chaos and Confusion’ at the N.I.H., the Crown Jewel of American Science

Senior scientists at the National Institutes of Health fear that research on conditions like obesity, heart disease and cancer will be undermined by President Trump’s policies.A week after Donald J. Trump was inaugurated, a senior scientist at the National Institutes of Health was preparing to give an invited talk at a scientific meeting when an urgent call came in from an administrative assistant.There is a total communications ban, the scientist was told, and you cannot give the speech.As soon as the scientist got back to the office, another ban went into effect — one that prohibited researchers from submitting papers to journals for publication.Seven senior investigators working in different parts of the National Institutes of Health described rules put in place on orders from the Department of Government Efficiency that risk hampering and undermining American medical science. All spoke on the condition of anonymity because they feared for their jobs for speaking publicly.One said that DOGE had begun a reign of “chaos and confusion.” The scientists warned that it had the potential to seriously weaken the N.I.H. — the crown jewel of American science, with a vast network of thousands of researchers in 27 centers dedicated to treating disease, improving health and funding medical research.Rules change seemingly from day to day.Can scientists order necessary supplies to do their research? Yes. No. Maybe.Can they travel? A 30-day ban was put in place on Feb. 26. What happens next? No one knows.“It really is quite chilling,” one of the scientists said. “They are controlling information, causing chaos, disrupting everyone, keeping us off-balance.”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.

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Kennedy Instructs Anti-Vaccine Group to Remove Fake C.D.C. Page

Children’s Health Defense, founded by the health secretary, had published online a vaccine-safety page that looked like the agency’s but that suggested links to autism.Robert F. Kennedy Jr., the nation’s health secretary, on Saturday instructed leaders of the nonprofit he founded to take down a web page that mimicked the design of the Centers for Disease Control and Prevention’s site but laid out a case that vaccines cause autism.The page had been published on a site apparently registered to the nonprofit, the anti-vaccine group Children’s Health Defense. Mr. Kennedy’s action came after The New York Times inquired about the page and after news of it ricocheted across social media.The page was taken offline Saturday evening. “Secretary Kennedy has instructed the Office of the General Counsel to send a formal demand to Children’s Health Defense requesting the removal of their website,” the Health and Human Services Department said in a statement.“At H.H.S. we are dedicated to restoring our agencies to their tradition of upholding gold-standard, evidence-based science,” the statement said.It was not clear why the anti-vaccine group might have published a page mimicking the C.D.C.’s. The organization did not respond to requests for comment, and Mr. Kennedy has said he severed ties with it when he began his presidential campaign in 2023.The fake vaccine safety page was practically indistinguishable from the one available on the C.D.C.’s own site. The layout, typefaces and logos were the same, perhaps in violation of federal copyright law.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.

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Kitty Dukakis, Wife of 1988 Presidential Nominee, Dies at 88

Married to Gov. Michael Dukakis of Massachusetts, she became a proponent of electroshock therapy after unsuccessful treatments for alcoholism and depression.Kitty Dukakis, an activist first lady and humanitarian, who overcame alcoholism and depression with the help of electroconvulsive therapy, then became a proponent of the treatment with her husband, Michael S. Dukakis, the former Massachusetts governor and the 1988 Democratic presidential nominee, died on Friday night at her home in Brookline, Mass. She was 88. Her son, John, told the news media that the cause was complications of dementia.Mrs. Dukakis was a longtime activist on behalf of underdogs and people who struggled. Among the subjects most important to her was continuing education on the Holocaust. She was appointed by President Jimmy Carter in 1978 to the first President’s Commission on the Holocaust, which sought to create a national memorial and museum; when that panel was replaced a decade later by the United States Holocaust Memorial Council, she was appointed to the council by President George H.W. Bush.“Perhaps in the entire history of civilization, the Holocaust was the most important object lesson in man’s inhumanity to man,” she told the National Governors Association in 1983.Few political wives have been as forthright as Mrs. Dukakis in sharing the intimate details of their struggles with addiction and depression. She wrote two books that revealed in painful detail her early dependence on diet pills, how alcoholism later took over her life and how she turned, at age 64, to electroshock therapy to treat the crippling depression that she said had long been masked by her drinking.Her successful electroshock treatment led her and her husband to publicly advocate for the effectiveness of the procedure, and even to hold support groups at their home.But for most of her time in the spotlight, she carefully concealed her drinking and her depression.She worked as a modern dance teacher and immersed herself in numerous causes as her husband pursued his political career. Passionately committed to helping the underdog, she devoted herself to projects involving the homeless, refugees, AIDS and the Holocaust.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.

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Inside the Turmoil at the V.A. Mental Health System Under Trump

Late in February, as the Trump administration ramped up its quest to transform the federal government, a psychiatrist who treats veterans was directed to her new workstation — and was incredulous.She was required, under a new return-to-office policy, to conduct virtual psychotherapy with her patients from one of 13 cubicles in a large open office space, the kind of setup used for call centers. Other staff might overhear the sessions, or appear on the patient’s screen as they passed on their way to the bathroom and break room.The psychiatrist was stunned. Her patients suffered from disorders like schizophrenia and bipolar disorder. Treating them from her home office, it had taken many months to earn their trust. This new arrangement, she said, violated a core ethical tenet of mental health care: the guarantee of privacy.When the doctor asked how she was expected to safeguard patient privacy, a supervisor suggested she purchase privacy screens and a white noise machine. “I’m ready to walk away if it comes to it,” she wrote to her manager, in a text message shared with The New York Times. “I get it,” the manager replied. “Many of us are ready to walk away.”Scenes like this have been unfolding in Veterans Affairs facilities across the country in recent weeks, as therapy and other mental health services have been thrown into turmoil amid the dramatic changes ordered by President Trump and pushed by Elon Musk’s Department of Government Efficiency.Among the most consequential orders is the requirement that thousands of mental health providers, including many who were hired for fully remote positions, now work full time from federal office space. This is a jarring policy reversal for the V.A., which pioneered the practice of virtual health care two decades ago as a way to reach isolated veterans, long before the pandemic made telehealth the preferred mode of treatment for many Americans.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.

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