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Bill could end holdup for California research on psychedelics and addiction treatment

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Bill could end holdup for California research on psychedelics and addiction treatment

California lawmakers could soon clear a governmental logjam that has held up dozens of studies related to addiction treatment, psychedelics or other federally restricted drugs.

The holdup revolves around the Research Advisory Panel of California, established decades ago to vet studies involving cannabis, hallucinogens and treatments for “abuse of controlled substances.”

It has been a critical hurdle for California researchers exploring possible uses of psychedelics or seeking new ways to combat addiction. Scientists cannot move forward with such research projects without the panel’s blessing.

The panel had long met behind closed doors to make its decisions, but concerns arose last year that it was supposed to fall under the Bagley-Keene Act, a state law requiring open meetings. Holding those meetings in public, however, raised alarm about exposing trade secrets and other sensitive information.

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So the panel stopped meeting at all. It has not convened since August. Meetings ordinarily scheduled for every other month have been canceled since October.

The result has been a ballooning backlog: As of early May, there were 42 new studies and 28 amendments to existing projects awaiting approval, according to state officials.

Ziva Cooper, director of the UCLA Center for Cannabis and Cannabinoids, said she had submitted one study to the California panel over a year ago — one already approved by the National Institutes of Health, the Food and Drug Administration, and an institutional review board. That research will assess the health risks of cannabis for seniors and young adults ages 18 to 25, two groups whose cannabis use has been on the rise, she said. Cooper said the panel sought a small change: adjusting two words in a consent form for study participants. But because the panel has not been meeting, she has been unable to proceed.

The holdup has also snarled two other studies her UCLA center had submitted to the panel — one examining whether cannabis could be used as an alternative to opioids for pain relief, another on whether a psychedelic compound found in mushrooms, psilocybin, could help treat people struggling with cocaine addiction.

And Cooper said she hasn’t even bothered to submit three more studies, including research on the effects of high-potency cannabis. The holdup has left Cooper and other researchers fearing they could lose funding for planned studies or be forced to lay off staff.

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The idea of having to study something different because “in California I can’t do the research that I’m trained to do … is demoralizing,” Cooper said. It aggravates her “to not be able to answer the questions that are desperately needed right now” as the range of cannabis products on the market has grown.

The standstill “has broad implications, costing researchers money in expired grants and contingent grants, shortened patents on new drugs, lost wages for research personnel, lost talent, and lost costs of research drugs for human use that will expire before use,” according to an analysis prepared for a state committee.

That long hiatus could soon end: Under Assembly Bill 2841, the state panel would be able to hold closed sessions to discuss studies that involve trade secrets or other proprietary information. The bill, proposed by Assemblymember Marie Waldron (R-Valley Center), would go into effect immediately if signed by the governor.

“We are focused on reactivating the large amount of research studies that have been on hold for over a year now,” Waldron said in a statement. “This is the quick and urgent solution needed to address that problem.”

The bill is supported by the nonprofit Veterans Exploring Treatment Solutions, which supports research into the possible benefits of psychedelics for treating depression and other conditions among military veterans and helps them obtain such treatment abroad.

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“Psychedelic research has ground to halt in California — including numerous VA studies, “ said its director of public policy, Khurshid Khoja. If the Legislature does not act swiftly, the state will see “a rapid exodus of skilled researchers from California universities and research institutions to pursue their critically important work elsewhere — not to mention capital flight by funders who’ll deploy research dollars outside the state.”

“AB 2841 is an urgently needed response to address this crisis,” Khoja said.

To many researchers, however, AB 2841 does not go far enough. Dozens of scientists have called for the panel to be eliminated, arguing that even when it was meeting regularly, it was an unnecessary obstruction to research already being scrutinized by other government and institutional reviewers.

In a letter to Gov. Gavin Newsom, a coalition of researchers argued that undergoing the state review could delay a study by at least five months, resulting in more than $100,000 in “unnecessary staff expenditures” in that time. Because other states don’t have that hurdle, they argued, California researchers are losing out on competitive funding — and Californians miss chances to participate in local trials for emerging treatments.

UCLA psychologist and addiction researcher Steven Shoptaw called it “an unequal burden on addiction research” compared with other scientific studies.

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The California panel has been vetting not only studies that involve federally restricted drugs, but also those assessing any kind of medication to treat addiction, said Dr. Phillip Coffin, a UC San Francisco professor of medicine who has called to eliminate the panel.

“If I’m testing Prozac for depression, or Prozac for any other disease, I can do my research without waiting” for the committee, he said, but “If I’m testing Prozac for addiction, I have to wait.” By maintaining such barriers, Coffin argued, “we are seriously harming any chance California has of responding to the addiction crisis.”

Short of eliminating the panel, some have also argued for amending the law to exempt any researchers who have gotten federal approval to do such research.

Others have argued that the panel has a valuable role, even for studies that have undergone review by the FDA or other entities. An analysis of AB 2841 prepared for the Assembly Committee on Health said state data from the Department of Justice show that the Research Advisory Panel regularly catches issues with drug safety, consent forms missing important information about safety and privacy, and other potential problems.

The panel “has a record of providing an extra level of protection, which is important given the volume of controlled substance research that occurs in California,” the analysis said. In addition, the committee analysis said the panel is “the only one which ensures that studies conducted in California comply with state law.”

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Coffin disputed such arguments, saying that in his experience and that of many other researchers, its feedback had not “improved patient safety or remotely justified the extreme delays.”

If it is truly finding problems that have escaped other reviewers, he argued, “then all research — not just addiction treatment and controlled substances — should be forced to go through this panel.”

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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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