Day: June 4, 2024

washington — Federal health advisers voted Tuesday against a first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD, handing a potentially major setback to advocates who had hoped to win a landmark federal approval and bring the banned drugs into the medical mainstream. 

The panel of advisers to the Food and Drug Administration sided 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder. They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse. 

“It seems like there are so many problems with the data — each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have about how effective the treatment is,” said Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs. 

The FDA is not required to follow the group’s advice and is expected to make its final decision by August, but the negative opinion could strengthen FDA’s rationale for rejecting the treatment. 

The vote followed hours of pointed questions and criticisms about the research submitted on MDMA — sometimes called ecstasy or molly. Panelists pointed to flawed studies that could have skewed the results, missing follow-up data on patient outcomes, and a lack of diversity among participants. The vast majority of patients studied were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results. 

“The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the group’s patient representative. 

The FDA advisers also drew attention to allegations of misconduct in the trials that have recently surfaced in news stories and a report by the nonprofit Institute for Clinical and Economic Review, which evaluates experimental drug treatments. The incidents include a 2018 report of apparent sexual misconduct by a therapist interacting with a patient. 

Lykos Therapeutics, the company behind the study, said it previously reported the incident to the FDA and regulators in Canada, where the therapist is based. Lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the studies. The group was founded in 1986 to promote the benefits of MDMA and other mind-altering substances. 

MDMA is the first in a series of psychedelics — including LSD and psilocybin — that are expected to come before the FDA in the next few years. The panel’s negative ruling could further derail financial investments in the fledgling industry, which has mainly been funded by a small number of wealthy backers. 

MDMA’s main effect is triggering feelings of intimacy, connection and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories. 

But the panel struggled with the reliability of those results, given the difficulties of objectively testing psychedelic drugs. 

Because MDMA causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. That’s the opposite of the approach generally required for high-quality drug research, in which bias is minimized by “blinding” patients and researchers to whether they received the drug under investigation. 

“I’m not convinced at all that this drug is effective based on the data I saw,” said Dr. Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel. 

Panelists also noted the difficulty of knowing how much of patients’ improvement came from MDMA versus simply undergoing the extensive therapy, which totaled more than 80 hours for many patients. Results were further marred by other complicating factors, including a large number of patients who had previously used MDMA or other psychedelics drugs recreationally. 
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The U.S. military says large groups of drones and ground robots can be managed by a single person without added stress to the operator. In this week’s episode of LogOn, VOA’s Julie Taboh reports the technologies may be beneficial for civilian uses, too. Videographer and video editor: Adam Greenbaum
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Washington — Many Americans still aren’t sold on going electric for their next car purchase. High prices and a lack of easy-to-find charging stations are major sticking points, a new poll shows.  

About 4 in 10 U.S. adults say they would be at least somewhat likely to buy an EV the next time they buy a car, according to the poll by The Associated Press-NORC Center for Public Affairs Research and the Energy Policy Institute at the University of Chicago, while 46% say they are not too likely or not at all likely to purchase one.  

The poll results, which echo an AP-NORC poll from last year, show that President Joe Biden’s election-year plan to dramatically raise EV sales is running into resistance from American drivers. Only 13% of U.S. adults say they or someone in their household owns or leases a gas-hybrid car, and just 9% own or lease an electric vehicle.  

Caleb Jud of Cincinnati said he’s considering an EV, but may end up with a plug-in hybrid — if he goes electric. While Cincinnati winters aren’t extremely cold, “the thought of getting stuck in the driveway with an EV that won’t run is worrisome, and I know it wouldn’t be an issue with a plug-in hybrid,″ he said. Freezing temperatures can slow chemical reactions in EV batteries, depleting power and reducing driving range.

A new rule from the Environmental Protection Agency requires that about 56% of all new vehicle sales be electric by 2032, along with at least 13% plug-in hybrids or other partially electric cars. Auto companies are investing billions in factories and battery technology in an effort to speed up the switch to EVs to cut pollution, fight climate change — and meet the deadline.  

EVs are a key part of Biden’s climate agenda. Republicans led by presumptive nominee Donald Trump are turning it into a campaign issue.  

Younger people are more open to eventually purchasing an EV than older adults. More than half of those under 45 say they are at least “somewhat” likely to consider an EV purchase. About 32% of those over 45 are somewhat likely to buy an EV, the poll shows.  

But only 21% of U.S. adults say they are “very” or “extremely” likely to buy an EV for their next car, according to the poll, and 21% call it somewhat likely. Worries about cost are widespread, as are other practical concerns.  

Range anxiety – the idea that EVs cannot go far enough on a single charge and may leave a driver stranded — continues to be a major reason why many Americans do not purchase electric vehicles.  

About half of U.S. adults cite worries about range as a major reason not to buy an EV. About 4 in 10 say a major strike against EVs is that they take too long to charge or they don’t know of any public charging stations nearby.  

Concern about range is leading some to consider gas-engine hybrids, which allow driving even when the battery runs out. Jud, a 33-year-old operations specialist and political independent, said a hybrid “is more than enough for my about-town shopping, dropping my son off at school” and other uses.  

With EV prices declining, cost would not be a factor, Jud said — a minority view among those polled. Nearly 6 in 10 adults cite cost as a major reason why they would not purchase an EV.  

Price is a bigger concern among older adults.  

The average price for a new EV was $52,314 in February, according to Kelley Blue Book. That’s down by 12.8% from a year earlier, but still higher than the average price for all new vehicles of $47,244, the report said.

Jose Valdez of San Antonio owns three EVs, including a new Mustang Mach-E. With a tax credit and other incentives, the sleek new car cost about $49,000, Valdez said. He thinks it’s well worth the money.  

“People think they cost an arm and a leg, but once they experience (driving) an EV, they’ll have a different mindset,” said Valdez, a retired state maintenance worker. 

The 45-year-old Republican said he does not believe in climate change. “I care more about saving green” dollars, he said, adding that he loves the EV’s quiet ride and the fact he doesn’t have to pay for gas or maintenance. EVs have fewer parts than gas-powered cars and generally cost less to maintain. Valdez installed his home charger himself for less than $700 and uses it for all three family cars, the Mustang and two older Ford hybrids.

With a recently purchased converter, he can also charge at a nearby Tesla supercharger station, Valdez said.  

About half of those who say they live in rural areas cite lack of charging infrastructure as a major factor in not buying an EV, compared with 4 in 10 of those living in urban communities.  

Daphne Boyd, of Ocala, Florida, has no interest in owning an EV. There are few public chargers near her rural home “and EVs don’t make any environmental sense,″ she said, citing precious metals that must be mined to make batteries, including in some countries that rely on child labor or other unsafe conditions. She also worries that heavy EV batteries increase wear-and-tear on tires and make the cars less efficient. Experts say extra battery weight can wear on tires but say proper maintenance and careful driving can extend tire life.  

Boyd, a 54-year-old Republican and self-described farm wife, said EVs may eventually make economic and environmental sense, but “they’re not where they need to be” to convince her to buy one now or in the immediate future.

Ruth Mitchell, a novelist from Eureka Springs, Arkansas, loves her EV. “It’s wonderful — quiet, great pickup, cheap to drive. I rave about it on Facebook,″ she said.

Mitchell, a 70-year-old Democrat, charges her Chevy Volt hybrid at home but says there are several public chargers near her house. She’s not looking for a new car, Mitchell said, but when she does it will be electric: “I won’t drive anything else.”
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