Science
A California panel is holding up studies on psychedelics. Some researchers want it gone
At the Pacific Neuroscience Institute in Santa Monica, scientists are eager to explore whether a psychedelic chemical found in a toad could help people whose depression has not eased with typical treatments. Patients regularly call or send emails about joining clinical trials to test that and other compounds, but the research center is turning them away.
“We have to tell them we don’t have any studies enrolling right now,” said Dr. Keith Heinzerling, director of the institute’s TRIP Center, which focuses on treatment and research on psychedelics. “We’ve been put on hold by the state.”
Across the state, dozens of such studies are in limbo thanks to a little-known government panel that monitors research on federally restricted drugs and addiction treatment.
The holdup, tied to a state law requiring government meetings to be held in public, has dragged on since the fall and galvanized some scientists to push for the panel to be dissolved.
Lawmakers in Sacramento established the Research Advisory Panel of California more than half a century ago to vet studies involving cannabis, hallucinogens and treatments for “abuse of controlled substances,” according to the state’s health and safety code.
The panel, which includes representatives of state agencies and universities, has the power to reject studies if they are poorly conceived, would produce little of scientific value, or would expose Californians who sign on as research subjects to excessive risk. It also monitors ongoing research and can revoke its approval if studies veer from what it approved.
Getting the panel’s blessing is a crucial hurdle for researchers working in the state to find better ways to treat drug addiction, a crisis leading to more than 100,000 overdose deaths across the country each year. The panel also has oversight over research in the burgeoning field of psychedelics, which is developing potential treatments for depression, substance use disorder and other conditions.
The panel typically meets every other month, but gatherings scheduled for October and December were canceled with little explanation. Scientists waiting for the go-ahead to launch their studies say they’ve received no information about when meetings will resume.
Among those frustrated by the standstill is David, a 50-year-old grappling with post-traumatic stress disorder. The Los Angeles resident, who asked not to be identified by his full name to protect his medical privacy, reached out to the Pacific Neuroscience Institute to ask about upcoming clinical trials.
“I’ve been in search of a treatment that will alleviate symptoms of PTSD for a long time,” David said. Some existing treatments “have worked pretty well, but there are still times where there’s challenges and episodes that can be pretty destabilizing,” including prolonged bouts of insomnia.
The potential of a psychedelic compound like psilocybin is appealing, but since he’s in recovery for alcohol use, David wants to try it only if it’s administered by medical professionals in a therapeutic environment. The Santa Monica center told him their next possible trial was being held up indefinitely.
“It just seems like the gears of bureaucracy conspire against meaningful solutions,” he said.
At UC San Francisco, Dr. Josh Woolley said two of his planned studies on psilocybin are on indefinite hold. One of them is for young adults with anorexia, a disorder that can significantly ramp up the risk of death if left untreated. Now “we don’t know when it will be approved,” said Woolley, director of the Translational Psychedelic Research Program at UCSF.
The holdup has also interrupted plans for Dr. Charles Grob, a psychiatrist doing research with the Lundquist Institute at Harbor-UCLA Medical Center to examine whether psilocybin could help patients suffering from existential anxiety and demoralization near the end of life.
“Just when things are ready to take off with more research, the field is frozen,” Grob said.
Just when things are ready to take off with more research, the field is frozen.
— Dr. Charles Grob, a psychiatrist with the Lundquist Institute at Harbor-UCLA Medical Center
Several current or former members of the panel declined to comment or did not respond to messages. Dr. Tanveer Khan, the panel’s executive officer, referred questions to the California attorney general’s office.
In a statement, the office said the panel was created to ensure that research involving addiction or certain controlled substances is tracked by the state and proceeds safely in line with “best medical practices and California law.” It attributed the interruption in its meetings to concerns about how a state law requiring public meetings might apply to the panel, but declined to clarify whether those concerns were prompted by recent changes to the Bagley-Keene Open Meetings Act or a new interpretation of existing rules.
Before it stopped meeting altogether, the Research Advisory Panel routinely convened behind closed doors. Scientists argued that meeting in public would be a nonstarter with funders who wanted to protect their intellectual property.
“Realistically, the pharmaceutical companies are not going to allow their stuff to be reviewed in public, unless there’s a very well-thought-out process that protects their interests,” Heinzerling said.
The backlog of studies awaiting review and approval has ballooned since the panel last met in August. By December, 33 new proposals were on ice, as were 13 amendments to existing research projects, according to the attorney general’s office.
The attorney general’s office said it was working with lawmakers and the governor’s office on a legislative solution to resolve the problem but declined to give specifics.
The impasse, first reported in the newsletter Psychedelic Alpha, has deepened longtime frustrations among scientists who argue that even when the panel is meeting normally, it is an outdated and unnecessary entity that slows down vital research.
Dozens of researchers in a newly formed consortium are now calling for the panel to be eliminated. They argue that studies involving controlled substances and addiction treatment are vetted by other oversight boards and that the California panel often rehashes issues that were already decided by other regulators.
Psychologist Steven Shoptaw, director of the Center for Behavioral and Addiction Medicine at UCLA, said there was a time when such experiments were conducted on people in jails and other settings who could not freely consent. But the rigorous scrutiny from institutional review boards, the Food and Drug Administration, the National Institutes of Health and others now makes the California panel obsolete, he said.
“I’ve never understood why this was not dismantled decades ago,” said Shoptaw, who has studied possible treatments for people who use methamphetamine.
Stanford University clinical psychologist Keith Humphreys said he was asked to join the panel years ago by then-Gov. Jerry Brown, but he declined “because I could see no purpose to it.”
“I just thought, ‘We have an FDA. We have an NIH. Why is the state doing this?’” Humphreys said.
We have an FDA. We have an NIH. Why is the state doing this?
— Stanford clinical psychologist Keith Humphreys
Even without hiccups, undergoing the state review can delay a study for upward of five months, researchers complained. That means wasting $100,000 or more on “unnecessary staff expenditures” during that time, they argued in a letter sent Thursday to Gov. Gavin Newsom and other decision makers.
Such delays can also shut Californians out of multi-state trials of emerging treatments, scientists argue. The lag time now looms larger as medication studies are expected to be run more quickly — within as little as a year instead of five, they said.
“If you’re competing against other states where they don’t have this delay, the industry is going other places,” said Woolley of UC San Francisco.
Dr. Phillip Coffin, director of the Center on Substance Use and Health at the San Francisco Department of Public Health, wanted to join a federally funded study on whether ketamine could help people struggling with methamphetamine addiction. But he said his site and others in California were excluded because of the panel’s delays.
Losing out on the ketamine study and other research opportunities means that “I won’t be able to hire or I will have to let go of staff,” Coffin said.
Compass Pathways, a London biotech firm developing psilocybin treatments, decided not to establish a new “centre of excellence” in San Diego. In an email sent in 2019 to a San Diego researcher, company co-founder George Goldsmith cited the “incredibly slow” state panel as a reason. (A Compass representative reached this week said the company’s clinical trials for depression treatments underway in California had not encountered any delays.)
Many researchers are frustrated that the panel has been reviewing trials for addiction treatment even if they involve ordinary medications. For instance, the panel vetted a study Coffin undertook on mirtazapine — an FDA-approved antidepressant — as a treatment for people who use meth.
In 2022, the panel reviewed 52 new applications plus two submitted the previous year, according to its most recent available annual report. Among those 54 applications, three were either not approved or withdrawn. The reasons weren’t given in the report.
By the end of that year, the panel was monitoring 132 ongoing research projects, including studies on whether cannabis use affects antiretroviral therapy and how psilocybin helps people suffering from phantom limb pain.
Michiel van Elk, who studies altered states of consciousness at Leiden University in the Netherlands, said he wasn’t familiar with the California panel, but could understand the need for a specialized review board because assessing research procedures for psychedelics poses some unique challenges.
“It is really difficult to evaluate the risks of the drug itself, because it always interacts with the mind-set of the person and also with the setting in which it’s administered,” Van Elk said. In general, “our current system is not set up for dealing with those type of challenges.”
Not all researchers who interact with the panel are joining the calls to eliminate it. Grob said going through the panel is “extra work, but it’s been positive,” praising its members as astute and helpful.
“California has this extra layer of regulatory oversight, but the problem is not the committee itself,” he said. “It’s that the committee is unable to do its job.”
Science
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.
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.
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.
Pet owners can consult a veterinarian about leptospirosis vaccinations and should keep pets away from ponds, lakes and other natural bodies of water.
Science
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.
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.
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.
“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.
“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.
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.
“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.
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.”
Science
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