Hospitals and Nursing Homes in Milton’s Path Prepare for the Storm

Healthcare facilities across the west coast of Florida, from clinics to nursing homes, are temporarily shutting their doors and evacuating patients in preparation for Hurricane Milton’s potentially devastating landfall.Mandatory evacuation orders in Pinellas County, which includes Clearwater and St. Petersburg, affect about 6,600 patients at six hospitals, 25 nursing homes and 44 assisted living facilities, according to the order. Scores of medical clinics and dialysis centers across the region have also closed, including dozens of outpatient facilities operated by the BayCare, a health care network.The region’s only Level 1 trauma center, Tampa General Hospital, has deployed a temporary flood barricade that officials hope will stave off the storm surge. Most of the hospitals in the region that are still open have suspended elective operations or have stopped accepting new patients.University of Florida Health, which operates about a dozen hospitals across the state, had enough food, water and fuel to keep its facilities operating for 96 hours, according to Peyton Wesner, a spokesman.Mary Mayhew, president of the Florida Hospital Association, said many facilities have improved their emergency preparedness in recent years by creating backup water supplies, acquiring generators and purchasing satellite telephones in case cell service is disrupted. Most hospitals have moved key infrastructure to higher floors.But Ms. Mayhew said there was only so much to be done in the face of a storm as powerful as Milton. “In the last few years, hospitals in Florida have had to frequently deal with these types of emergencies, but there is undoubtedly a heightened sense of concern given the magnitude of this storm and where it is likely they hit,” she said.During Hurricane Ian in 2022, Lee Health, a hospital network south of Tampa, was forced to bring in 10 water tankers when municipal water service was disrupted, which prompted evacuations at two of its hospitals. Though no water entered the hospital itself, flooding damaged or destroyed 400 cars in the hospital’s parking lot.“With every storm, we learn things, and we certainly learned about the dangers of storm surge,” said Dr. Larry Antonucci, the system’s president, noting that hospital employees have been asked to consider being dropped off at the facilities by someone else, or using ride share services. “We’re confident we can get through this.”Officials at Tampa General, which is surrounded by water on three sides, are hoping its temporary flood wall will keep the storm surge at bay, just as it did during Helene two weeks ago.The fence, manufactured by a Norwegian company, can withstand up to 15 feet of water, officials said. In one small dose of relief, hospital workers did not have to reinstall the fence to prepare for Milton: They simply never took it down.

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The Global Threat of Antibiotic Resistance

International health experts have begun to shift their focus to try to provide access to basic drugs in countries where preventable deaths from infections occur too frequently.An impoverished family in Africa is unable to afford a 50-cent course of antibiotics to save the life of a child with a simple bacterial infection. Is such a tragedy best described as a case of antimicrobial resistance, the slow-motion health emergency caused by the misuse of lifesaving antibiotics?For more than a decade, antimicrobial resistance has been framed as a problem of excess. The willy-nilly consumption of antibiotics, scientists said, have rendered the drugs less effective, leading to the unnecessary death of millions, many of them poor.But as global health officials gathered at the United Nations on Thursday to discuss the challenges posed by antimicrobial resistance, many have been promoting a more expansive understanding of the problem. It’s one based on preventing treatable infections through improved sanitation, higher vaccination rates and increased access to anti-infective drugs in lower-income countries.“Millions of people around the world have never even taken an antibiotic because they can’t afford them,” said Dr. Ramanan Laxminarayan, an economist and epidemiologist who has been promoting this new approach to antimicrobial resistance, much of it detailed in a recent series of journal articles in The Lancet. “We’re trying to move away from the issue of resistance, which is hard for the public to understand, and more to entitlement, which is that everyone should have access to an effective antibiotic.”Threading that needle — promoting greater access to antibiotics in some places while seeking to limit their use in others — won’t be easy.In the eight years since the U.N. held its first high-level meeting on antimicrobial resistance, the world has become increasingly familiar with the threats posed by untreatable infections.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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Three MDMA Studies Are Retracted by Scientific Journal

The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place.Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. In declining to approve Lykos’s application, the agency cited concerns about missing data and problems with the way the company’s study was designed, according to a statement released by Lykos on Friday.The F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.The journal retraction was first reported by Stat, the health and medical news website.On Sunday, Lykos said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications.“The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said in the statement.The incident cited by Psychopharmacology has been well documented. In 2015, an unlicensed Canadian therapist who took part in the trial engaged in a sexual relationship with a participant after the conclusion of the trial’s dosing sessionsIn civil court documents, the patient, Meaghan Buisson, said she was sexually assaulted by the therapist, Richard Yensen, who at the time was working alongside his wife, a licensed therapist. Mr. Yensen has said the relationship was consensual and initiated by Ms. Buisson. Six months after the final session, she moved from Vancouver to Cortes Island, in British Columbia, where the couple lived, according to court documents. The relationship between patient and practitioner continued for more than a year, the documents said. Professional associations in both Canada and the United States prohibit sexual relationships between psychologists and patients for at least two years after their final session. The incident helped highlight some of the challenges associated with psychedelic medicine, which can render patients especially vulnerable during dosing sessions. For that reason, most clinical trials involving psychedelic compounds require the presence of two mental health professionals. (Lykos’s trials with MDMA require only one of the practitioners to be licensed.)The Multidisciplinary Association for Psychedelic Studies, or MAPS, is the nonprofit that carried out the research and later created Lykos to market its proprietary MDMA-assisted therapy. The association publicly acknowledged the incident in 2019, adding that it had been reported to the F.D.A. and to Canadian health authorities.The company acknowledged on Sunday that it had failed to notify Psychopharmacology about the violations, but it said that the oversight should have been addressed through a correction, not a retraction.

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F.D.A. Declines to Approve MDMA Therapy, Seeking More Study

The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy, according to the company seeking approval.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dashing the hopes of many Americans with intractable mental health conditions who are desperate for new treatments.According to Lykos Therapeutics, the company that had sought approval for the treatment, the agency said there was insufficient data to allow its use. The company said that the F.D.A is requesting an additional clinical trial, to continue to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.Had it been approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities.Outright approval by the F.D.A. would have been a watershed moment in the decades-long effort by researchers to demonstrate the healing potential of compounds like LSD and psilocybin, the psychoactive component of so-called magic mushrooms.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and rejected the company’s application. With regard to two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that its benefits did not outweigh the risks.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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Veterans and Lawmakers Lobby for Approval of MDMA Therapy

The F.D.A. is poised to rule on the therapeutic use of the club drug Ecstasy, a potential watershed moment in the nascent field of psychedelic medicine.More than a half century after federal regulators banned most psychedelic compounds, the Food and Drug Administration is nearing a decision on a novel treatment for post-traumatic stress disorder that pairs talk therapy with MDMA, the club drug commonly known as Ecstasy or Molly.The decision, which is expected in the coming days, has generated a groundswell of lobbying by veterans groups, researchers and members of Congress from both parties. Eighty lawmakers signed letters to the Biden administration this week, urging the F.D.A. to approve the application by the drug company Lykos Therapeutics.The campaign was prompted in part by an expert panel’s unanimous rejection in June of Lykos’s application, because of what participants said were flaws in the company’s clinical trials and insufficient data.“We have a mental health crisis and a suicide epidemic, with thousands of military veterans taking their own lives every year,” said Representative Jack Bergman, Republican of Michigan and a former Marine Corps general who helped organize the letter’s 60 backers in the House. “I would just ask the F.D.A. to consider the negative ramifications of them not taking action, which means more veterans will die needlessly.”The lobbying campaign, unusual for a prospective new drug, underscores the high stakes and intense emotions surrounding psychedelic medicine, a field that has been growing in recent years as the country’s top universities race one another to establish psychedelic research institutes.The passions — and the millions of dollars in private investment flooding the field — have been buoyed by a growing body of data suggesting that compounds like LSD, psilocybin mushrooms and MDMA can have significant therapeutic effects on hard-to-treat mental health conditions like depression, anxiety and obsessive compulsive disorder. The federally prohibited substances are listed as Schedule I drugs that have “no currently accepted medical use and a high potential for abuse.”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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This Is Literally Your Brain on Drugs

A small new study shows reactions in the brain in people who were given psilocybin in a controlled setting.If you had to come up with a groovy visualization of the human brain on psychedelic drugs, it might look something like this.Sara Moser/Washington University School of MedicineThe image, as it happens, comes from dozens of brain scans produced by researchers at Washington University School of Medicine in St. Louis who gave psilocybin, the compound in “magic mushrooms,” to participants in a study before sending them into a functional M.R.I. scanner.The kaleidoscopic whirl of colors they recorded is essentially a heat map of brain changes, with the red, orange and yellow hues reflecting a significant departure from normal activity patterns. The blues and greens reflect normal brain activity that occurs in the so-called functional networks, the neural communication pathways that connect different regions of the brain.The scans, published Wednesday in the journal Nature, offer a rare glimpse into the wild neural storm associated with mind-altering drugs. Researchers say they could provide a potential road map for understanding how psychedelic compounds like psilocybin, LSD and MDMA can lead to lasting relief from depression, anxiety and other mental health disorders.“Psilocybin, in contrast to any other drug we’ve tested, has this massive effect on the whole brain that was pretty unexpected,” said Dr. Nico Dosenbach, a professor of neurology at Washington University and a senior author of the study. “It was quite shocking when we saw the effect size.”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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FDA Panel Rejects Use of MDMA for Treatment of PTSD

An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using an illegal drug commonly known as Ecstasy.Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. Many questions focused on the fact that study participants were by and large able to correctly guess whether they had been given MDMA, also known by the names of Ecstasy or molly. The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks.Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.Many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being.“I absolutely agree that we need new and better treatments for PTSD,” said Paul Holtzheimer, deputy director for research at the National Center for PTSD, a panelist who voted no on the question of whether the benefits of MDMA-therapy outweigh the risks.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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FDA Panel Weights MDMA Therapy for PTSD

An independent group of experts is meeting Tuesday to consider whether to allow use of this illegal drug, also known as Ecstasy, to treat PTSD. The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.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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FDA Approves Antibiotic to Treat Urinary Infections

Pivmecillinam, which has been used in Europe for decades, will become available next year to women 18 and older.The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs.The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older.It is the first time in two decades that the F.D.A. has approved a new antibiotic for U.T.I.s, which annually affect 30 million Americans. U.T.I.s are responsible for the single-greatest use of antibiotics outside a hospital setting.“Uncomplicated U.T.I.s are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” Dr. Peter Kim, director of the Division of Anti-Infectives at the F.D.A.’s Center for Drug Evaluation and Research, said in a statement. “The F.D.A. is committed to fostering new antibiotic availability when they prove to be safe and effective.”Utility Therapeutics, the U.S. company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking F.D.A. approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a hospital setting.Health practitioners said they were elated to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing medications less effective as pathogens mutate in ways that allow them to survive a course of antibiotics.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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Eyeglasses Improve Income as Well as Sight, Study Shows

A study found that when farsighted workers in Bangladesh were given free reading glasses, they earned 33 percent more than those who had not.If you’re 50 or older and reading this article, chances are you are wearing a pair of inexpensive reading glasses to correct your presbyopia, or farsightedness, the age-related decline in vision that makes it progressively more difficult to see fine print and tiny objects.Eventually, everyone gets the condition.But for nearly a billion people in the developing world, reading glasses are a luxury that many cannot afford. According to the World Health Organization, the lack of access to corrective eyewear inhibits learning among young students, increases the likelihood of traffic accidents and forces millions of middle-age factory workers and farmers to leave the work force too early.Uncorrected presbyopia, not surprisingly, makes it harder for breadwinners to support their families. That’s the conclusion of a new study which found that garment workers, artisans and tailors in Bangladesh who were provided with free reading glasses experienced a 33 percent increase in income compared to those who were not given glasses.The study, published on Wednesday in the journal PLOS One, included more than 800 adults in rural Bangladesh, many of whom work in jobs that require intense attention to detail. Half of the participants — a mix of tea pickers, weavers and seamstresses between 35 and 65 — were randomly chosen to receive a free pair of reading glasses. The others were not given glasses.Researchers followed up eight months later and found that the group with glasses had experienced a significant bump in income, receiving an average monthly income of $47.10, compared to $35.30 for the participants who did not have glasses.The study subjects were evenly divided between male and female, and slightly more than a third were literate.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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