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U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide

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U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide

Federal regulators have suspended research on human subjects at the Columbia-affiliated New York State Psychiatric Institute, one of the country’s oldest research centers, as they investigate safety protocols across the institute after the suicide of a research participant.

A spokesperson for the U.S. Department of Health and Human Services, Kate Migliaccio-Grabill, confirmed on Wednesday that the agency’s Office of Human Research Protections was investigating the psychiatric institute “and has restricted its ability to conduct H.H.S.-supported human subject research.”

About two weeks before the federal order, on June 12, the institute had “voluntarily paused all studies that included ongoing interactions with human subjects,” according to Carla Cantor, the institute’s director of communications. The decision affected 417 studies, of which 198 have continuing participation. Of those, 124 receive federal funding.

It is unusual for the U.S. regulatory office to suspend research, and this suggests that investigators are concerned that potential violations of safety protocols occurred more broadly within the institute. Almost 500 studies, with combined budgets totaling $86 million, are underway at the institute, according to its website.

The inquiry followed the death by suicide of a person enrolled in a study led by Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University who was testing a drug for Parkinson’s disease, levodopa, as a treatment for depression and reduced mobility in older people.

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Dr. Rutherford resigned his position at the institute on June 1 and is no longer a faculty member of Columbia’s psychiatry department, Ms. Cantor said. Dr. Rutherford did not respond to requests for comment left at his home and office.

Asked about the reported suicide, Ms. Cantor would not confirm that a death had occurred during a clinical trial, saying the institute could not provide any information about study participants because of health privacy laws.

The institute’s “top priority is the health and safety of individuals engaged in our award-winning research problems,” Ms. Cantor said in a statement.

She said the institute “worked to assist federal agencies in their audit and has subsequently restructured and strengthened its research compliance and monitoring programs across the institution.”

The institute, which is operated by the state Office of Mental Health, is seeking federal approval for a new research safety plan so that federally funded studies can resume, she said. It is also conducting a safety review of human research studies not funded by the federal government, which is expected to be complete next month.

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After the initial audit of the Rutherford laboratory, the National Institutes of Health requested an external audit of all federally funded research, she said.

A spokeswoman for the N.I.H., Amanda Fine, said the agency was working closely with the Office of Human Research Protections, which is investigating the matter. N.I.H. cannot discuss matters under review, she said.

The subject’s suicide was reported earlier in Spectrum, a news site focusing on autism research. But the U.S. agency’s decision to order a widespread halt to other studies had not been disclosed before now.

The trial of levodopa for late-life depression, which began in 2018 and received $736,579 in funding from the National Institute of Mental Health, aimed to recruit 90 adults over the age of 60 who suffered from mild to moderate depression and a slowed gait.

The team ended up with just 51, of whom 20 dropped out or were found ineligible, according to records provided to federal oversight agencies. The 31 who remained were assigned to one of two groups, one taking levodopa and one taking a placebo.

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On the website clinicaltrials.gov, under the heading “serious adverse events,” researchers reported that the individual who died by suicide had been assigned to the placebo arm of the study.

Dr. Rutherford and his co-authors published several articles based on the trial, reporting that levodopa, which increases dopamine concentrations, led to improvement in mobility, processing and depressive symptoms in the study population.

Dr. Bret R. Rutherford, who was an associate professor of psychiatry at Columbia University until he resigned in June.

The promising results were flagged in a commentary in The New England Journal of Medicine, which said that clinicians “might consider levodopa” for patients whose cognition or mobility did not respond to standard depression treatments.

It is not clear when the suicide occurred, but records show that the study was temporarily suspended by the National Institute of Mental Health in January 2022 and terminated in May 2023. This year, three scientific journals ran retractions identifying methodological errors in studies from Dr. Rutherford’s laboratory.

One of them pointed to a specific flaw: Eight subjects had only recently stopped taking an antidepressant, rather than waiting 28 days to “wash out,” as required by the study’s protocol. The average number of days those patients had been off medication was 10; one subject had been off medication only for a day.

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A member of Columbia’s faculty since 2010, Dr. Rutherford was a prolific researcher, having received 32 grants totaling more than $15.5 million from N.I.M.H. since 2010.

Subjects in the study were paid $15 in cash for weekly visits and an additional $400 for undergoing M.R.I. and PET scans.

Emily Roberts, a former research assistant in Dr. Rutherford’s laboratory and a co-author on one of his papers, told Spectrum that recruiting for the study had been challenging and that some criteria had been relaxed to increase enrollment.

Ms. Roberts, who managed the clinical trial in its first year, said the experience left her disillusioned and contributed to her decision to leave the field. “I was disappointed at the rigor of the research there,” she said. Ms. Roberts verified her comments to Spectrum, but she would not publicly comment further on the matter.

Some studies of psychiatric drugs require participants to “wash out” — to go off the medications they are taking and allow them to clear their system, so that scientists can test the effectiveness of a new one.

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This practice is specific to psychiatric research, and it creates a tension about what is best for patients, said Jeffrey Kahn, the director of the Berman Institute of Bioethics at Johns Hopkins University.

“There isn’t another category of drug trial where you ask someone to go off something they are on,” he said. “It’s a violation of a standard of care. You can’t tell someone, ‘Stop taking your chemotherapy so we can compare it to a new chemotherapy.’”

It is rare for regulators to halt research across an institution.

In 2015, the University of Minnesota suspended enrollment in psychiatric drug trials after a critical report by state auditors on the 2004 suicide of a patient who faced commitment to a state institution when he was enrolled in an industry-sponsored clinical trial of Seroquel, an antipsychotic drug.

In 2001, the Office for Human Research Protections ordered Johns Hopkins University to suspend almost all its federally financed medical research involving human subjects after the death of a volunteer who had inhaled an unapproved asthma drug.

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In 2000, the federal agency temporarily suspended all medical research involving human subjects at the University of Oklahoma after an investigation showed that patients had been injected with a vaccine that had been made by unqualified laboratory workers.

If you are having thoughts of suicide, call the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK) or go to SpeakingOfSuicide.com/resources for a list of additional resources.


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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

A cluster of workers at Ventura County berry farms have been diagnosed with a rare disease often transmitted through sick animals’ urine, according to a public health advisory distributed to local doctors by county health officials Tuesday.

The bacterial infection, leptospirosis, has resulted in severe symptoms for some workers, including meningitis, an inflammation of the brain lining and spinal cord. Symptoms for mild cases included headaches and fevers.

The disease, which can be fatal, rarely spreads from human to human, according to the U.S. Centers for Disease Control and Prevention.

Ventura County Public Health has not given an official case count but said it had not identified any cases outside of the agriculture sector. The county’s agriculture commissioner was aware of 18 cases, the Ventura County Star reported.

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The health department said it was first contacted by a local physician in October, who reported an unusual trend in symptoms among hospital patients.

After launching an investigation, the department identified leptospirosis as a probable cause of the illness and found most patients worked on caneberry farms that utilize hoop houses — greenhouse structures to shelter the crops.

As the investigation to identify any additional cases and the exact sources of exposure continues, Ventura County Public Health has asked healthcare providers to consider a leptospirosis diagnosis for sick agricultural workers, particularly berry harvesters.

Rodents are a common source and transmitter of disease, though other mammals — including livestock, cats and dogs — can transmit it as well.

The disease is spread through bodily fluids, such as urine, and is often contracted through cuts and abrasions that contact contaminated water and soil, where the bacteria can survive for months.

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Humans can also contract the illness through contaminated food; however, the county health agency has found no known health risks to the general public, including through the contact or consumption of caneberries such as raspberries and blackberries.

Symptom onset typically occurs between two and 30 days after exposure, and symptoms can last for months if untreated, according to the CDC.

The illness often begins with mild symptoms, with fevers, chills, vomiting and headaches. Some cases can then enter a second, more severe phase that can result in kidney or liver failure.

Ventura County Public Health recommends agriculture and berry harvesters regularly rinse any cuts with soap and water and cover them with bandages. They also recommend wearing waterproof clothing and protection while working outdoors, including gloves and long-sleeve shirts and pants.

While there is no evidence of spread to the larger community, according to the department, residents should wash hands frequently and work to control rodents around their property if possible.

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Pet owners can consult a veterinarian about leptospirosis vaccinations and should keep pets away from ponds, lakes and other natural bodies of water.

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Political stress: Can you stay engaged without sacrificing your mental health?

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Political stress: Can you stay engaged without sacrificing your mental health?

It’s been two weeks since Donald Trump won the presidential election, but Stacey Lamirand’s brain hasn’t stopped churning.

“I still think about the election all the time,” said the 60-year-old Bay Area resident, who wanted a Kamala Harris victory so badly that she flew to Pennsylvania and knocked on voters’ doors in the final days of the campaign. “I honestly don’t know what to do about that.”

Neither do the psychologists and political scientists who have been tracking the country’s slide toward toxic levels of partisanship.

Fully 69% of U.S. adults found the presidential election a significant source of stress in their lives, the American Psychological Assn. said in its latest Stress in America report.

The distress was present across the political spectrum, with 80% of Republicans, 79% of Democrats and 73% of independents surveyed saying they were stressed about the country’s future.

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That’s unhealthy for the body politic — and for voters themselves. Stress can cause muscle tension, headaches, sleep problems and loss of appetite. Chronic stress can inflict more serious damage to the immune system and make people more vulnerable to heart attacks, strokes, diabetes, infertility, clinical anxiety, depression and other ailments.

In most circumstances, the sound medical advice is to disengage from the source of stress, therapists said. But when stress is coming from politics, that prescription pits the health of the individual against the health of the nation.

“I’m worried about people totally withdrawing from politics because it’s unpleasant,” said Aaron Weinschenk, a political scientist at the University of Wisconsin–Green Bay who studies political behavior and elections. “We don’t want them to do that. But we also don’t want them to feel sick.”

Modern life is full of stressors of all kinds: paying bills, pleasing difficult bosses, getting along with frenemies, caring for children or aging parents (or both).

The stress that stems from politics isn’t fundamentally different from other kinds of stress. What’s unique about it is the way it encompasses and enhances other sources of stress, said Brett Ford, a social psychologist at the University of Toronto who studies the link between emotions and political engagement.

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For instance, she said, elections have the potential to make everyday stressors like money and health concerns more difficult to manage as candidates debate policies that could raise the price of gas or cut off access to certain kinds of medical care.

Layered on top of that is the fact that political disagreements have morphed into moral conflicts that are perceived as pitting good against evil.

“When someone comes into power who is not on the same page as you morally, that can hit very deeply,” Ford said.

Partisanship and polarization have raised the stakes as well. Voters who feel a strong connection to a political party become more invested in its success. That can make a loss at the ballot box feel like a personal defeat, she said.

There’s also the fact that we have limited control over the outcome of an election. A patient with heart disease can improve their prognosis by taking medicine, changing their diet, getting more exercise or quitting smoking. But a person with political stress is largely at the mercy of others.

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“Politics is many forms of stress all rolled into one,” Ford said.

Weinschenk observed this firsthand the day after the election.

“I could feel it when I went into my classroom,” said the professor, whose research has found that people with political anxiety aren’t necessarily anxious in general. “I have a student who’s transgender and a couple of students who are gay. Their emotional state was so closed down.”

That’s almost to be expected in a place like Wisconsin, whose swing-state status caused residents to be bombarded with political messages. The more campaign ads a person is exposed to, the greater the risk of being diagnosed with anxiety, depression or another psychological ailment, according to a 2022 study in the journal PLOS One.

Political messages seem designed to keep voters “emotionally on edge,” said Vaile Wright, a licensed psychologist in Villa Park, Ill., and a member of the APA’s Stress in America team.

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“It encourages emotion to drive our decision-making behavior, as opposed to logic,” Wright said. “When we’re really emotionally stimulated, it makes it so much more challenging to have civil conversation. For politicians, I think that’s powerful, because emotions can be very easily manipulated.”

Making voters feel anxious is a tried-and-true way to grab their attention, said Christopher Ojeda, a political scientist at UC Merced who studies mental health and politics.

“Feelings of anxiety can be mobilizing, definitely,” he said. “That’s why politicians make fear appeals — they want people to get engaged.”

On the other hand, “feelings of depression are demobilizing and take you out of the political system,” said Ojeda, author of “The Sad Citizen: How Politics is Depressing and Why it Matters.”

“What [these feelings] can tell you is, ‘Things aren’t going the way I want them to. Maybe I need to step back,’” he said.

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Genessa Krasnow has been seeing a lot of that since the election.

The Seattle entrepreneur, who also campaigned for Harris, said it grates on her to see people laughing in restaurants “as if nothing had happened.” At a recent book club meeting, her fellow group members were willing to let her vent about politics for five minutes, but they weren’t interested in discussing ways they could counteract the incoming president.

“They’re in a state of disengagement,” said Krasnow, who is 56. She, meanwhile, is looking for new ways to reach young voters.

“I am exhausted. I am so sad,” she said. “But I don’t believe that disengaging is the answer.”

That’s the fundamental trade-off, Ojeda said, and there’s no one-size-fits-all solution.

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“Everyone has to make a decision about how much engagement they can tolerate without undermining their psychological well-being,” he said.

Lamirand took steps to protect her mental health by cutting social media ties with people whose values aren’t aligned with hers. But she will remain politically active and expects to volunteer for phone-banking duty soon.

“Doing something is the only thing that allows me to feel better,” Lamirand said. “It allows me to feel some level of control.”

Ideally, Ford said, people would not have to choose between being politically active and preserving their mental health. She is investigating ways to help people feel hopeful, inspired and compassionate about political challenges, since these emotions can motivate action without triggering stress and anxiety.

“We want to counteract this pattern where the more involved you are, the worse you are,” Ford said.

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The benefits would be felt across the political spectrum. In the APA survey, similar shares of Democrats, Republicans and independents agreed with statements like, “It causes me stress that politicians aren’t talking about the things that are most important to me,” and, “The political climate has caused strain between my family members and me.”

“Both sides are very invested in this country, and that is a good thing,” Wright said. “Antipathy and hopelessness really doesn’t serve us in the long run.”

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

President-elect Donald Trump joined Elon Musk in Texas and watched the launch from a nearby location on Tuesday. While the Starship’s giant booster stage was unable to repeat a “chopsticks” landing, the vehicle’s upper stage successfully splashed down in the Indian Ocean.

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