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FDA panel to evaluate psychedelic MDMA for treatment of PTSD for first time

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FDA panel to evaluate psychedelic MDMA for treatment of PTSD for first time
  • A panel of advisers to the U.S. Food and Drug Administration will meet to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder.
  • The meeting is the farthest that a drug based on MDMA has ever reached in the FDA regulatory process for approval, following decades of activism.
  • In clinical trials in over 190 patients, those who received doses of MDMA in addition to therapy showed a significant reduction in PTSD scores compared to placebo.

A panel of advisers to the U.S. Food and Drug Administration will meet on Tuesday to discuss a therapy based on the psychedelic drug MDMA for patients with post-traumatic stress disorder (PTSD).

The meeting by the agency’s independent experts is the farthest that a drug based on MDMA, commonly known as ecstasy or molly, has ever reached in the FDA regulatory process for approval.

It follows a decades-long push by advocates who say drugs like MDMA can treat mental health disorders and have therapeutic applications beyond their illicit use.

MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL

The treatment is a capsule form of MDMA made by the public-benefit corporation Lykos Therapeutics and is intended to be administered along with sessions of talk therapy by a licensed mental health provider.

In clinical trials in over 190 patients, those who received doses of MDMA in addition to therapy showed a significant reduction in PTSD scores compared to placebo.

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However, the FDA’s staff reviewers on Friday raised concerns that patients in the trials were aware of whether they were given MDMA or a placebo due to its psychedelic effects, clouding how well the drug worked.

The headquarters of the Food and Drug Administration is seen in White Oak, Maryland, on August 29, 2020. The FDA met on June 4, 2024, to discuss the potential use of MDMA in treating PTSD. (Reuters/Andrew Kelly/File Photo)

“I don’t think that is as much of a concern because even if it is an enhanced placebo effect, people are still getting better,” said David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics.

“But the bigger question is what is the risk to those individuals?”

PTSD affects 13 million Americans and is especially common among war veterans. There remains a large unmet need for new treatments for PTSD as existing drugs do not work on all patients.

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The Lykos treatment is one among several psychedelic drugs being tested in patients with hard-to-treat mental health conditions such as Compass Pathways’ drug, which uses the same component as magic mushrooms.

The FDA’s staff proposed restrictions around its use and monitoring in their briefing documents on Friday. The FDA also flagged a rise in blood pressure and pulse in the trials and cases of liver toxicity.

The approval could offer “a new avenue of treatment, but itself is not going to make a big dent”, due to costs and complexities associated with it, said Olson.

“It’s important because it would be the first in this class of molecules, but I don’t think it will be the last, it will be replaced by compounds that have superior properties to MDMA.”

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally


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Alison Hammond’s Weight Loss: How She Shed 150 Lbs | Woman’s World




















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One state leads country in human bird flu with nearly 40 confirmed cases

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One state leads country in human bird flu with nearly 40 confirmed cases

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health (SFDPH).

As of Dec. 23, there had been 36 confirmed human cases of bird flu in the state, according to the California Department of Public Health (CDPH).

This represents more than half of the human cases in the country.

LOUISIANA REPORTS FIRST BIRD FLU-RELATED HUMAN DEATH IN US

The latest pediatric patient, who lives in San Francisco, experienced fever and conjunctivitis (pink eye) as a result of the infection.

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The unnamed patient was not hospitalized and has fully recovered, according to the SFDPH.

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health. (iStock)

The child tested positive for bird flu at the SFDPH Public Health Laboratory. The U.S. Centers for Disease Control and Prevention (CDC) will perform additional tests to confirm the result.

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It is not yet known how the child was exposed to the virus and an investigation is ongoing.

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“I want to assure everyone in our city that the risk to the general public is low, and there is no current evidence that the virus can be transmitted between people,” said Dr. Grant Colfax, director of health, in the press release. 

BIRD FLU PATIENT HAD VIRUS MUTATIONS, SPARKING CONCERN ABOUT HUMAN SPREAD

“We will continue to investigate this presumptive case, and I am urging all San Franciscans to avoid direct contact with sick or dead birds, especially wild birds and poultry. Also, please avoid unpasteurized dairy products.” 

Samuel Scarpino, director of AI and life sciences and professor of health sciences at Northeastern University in Boston, is calling for “decisive action” to protect individuals who may be in contact with infected livestock and also to alert the public about the risks associated with wild birds and infected backyard flocks. 

Chick bird flu test

An infectious diseases expert called for “decisive action” to alert the public about the risks associated with wild birds and infected backyard flocks.  (iStock)

“While I agree that the risk to the broader public remains low, we continue to see signs of escalating risk associated with this outbreak,” he told Fox News Digital.

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Experts have warned that the possibility of mutations in the virus could enable person-to-person transmission.

     

“While the H5N1 virus is currently thought to only transmit from animals to humans, multiple mutations that can enhance human-to-human transmission have been observed in the severely sick American,” Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, told Fox News Digital.

Split image of cows and bird flu vial

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture. (iStock)

“This highlights the requirement for vigilance and preparation in the event that additional mutations create a human-transmissible pandemic strain.”

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture (CDFA).

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In the last 30 days alone, the virus has been confirmed in 84 dairy farms in the state.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

“In the beginning, everyone thought they were going to find this one breakthrough pain drug that would replace opioids,” Gereau said. Increasingly, though, it’s looking like chronic pain, like cancer, could end up having a range of genetic and cellular drivers that vary both by condition and by the particular makeup of the person experiencing it. “What we’re learning is that pain is not just one thing,” Gereau added. “It’s a thousand different things, all called ‘pain.’”

For patients, too, the landscape of chronic pain is wildly varied. Some people endure a miserable year of low-back pain, only to have it vanish for no clear reason. Others aren’t so lucky. A friend of a friend spent five years with extreme pain in his arm and face after roughhousing with his son. He had to stop working, couldn’t drive, couldn’t even ride in a car without a neck brace. His doctors prescribed endless medications: the maximum dose of gabapentin, plus duloxetine and others. At one point, he admitted himself to a psychiatric ward, because his pain was so bad that he’d become suicidal. There, he met other people who also became suicidal after years of living with terrible pain day in and day out.

The thing that makes chronic pain so awful is that it’s chronic: a grinding distress that never ends. For those with extreme pain, that’s easy to understand. But even less severe cases can be miserable. A pain rating of 3 or 4 out of 10 sounds mild, but having it almost all the time is grueling — and limiting. Unlike a broken arm, which gets better, or tendinitis, which hurts mostly in response to overuse, chronic pain makes your whole world shrink. It’s harder to work, and to exercise, and even to do the many smaller things that make life rewarding and rich.

It’s also lonely. When my arms first went crazy, I could barely function. But even after the worst had passed, I saw friends rarely; I still couldn’t drive more than a few minutes, or sit comfortably in a chair, and I felt guilty inviting people over when there wasn’t anything to do. As Christin Veasley, director and co-founder of the Chronic Pain Research Alliance, puts it: “With acute pain, medications, if you take them, they get you over a hump, and you go on your way. What people don’t realize is that when you have chronic pain, even if you’re also taking meds, you rarely feel like you were before. At best, they can reduce your pain, but usually don’t eliminate it.”

A cruel Catch-22 around chronic pain is that it often leads to anxiety and depression, both of which can make pain worse. That’s partly because focusing on a thing can reinforce it, but also because emotional states have physical effects. Both anxiety and depression are known to increase inflammation, which can also worsen pain. As a result, pain management often includes cognitive behavioral therapy, meditation practice or other coping skills. But while those tools are vital, it’s notoriously hard to reprogram our reactions. Our minds and bodies have evolved both to anticipate pain and to remember it, making it hard not to worry. And because chronic pain is so uncomfortable and isolating, it’s also depressing.

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