FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD + More About MAPS

A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD).

The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.

FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD

H/T: The Most Revolutionary Act

The MAPS Public Benefit Corporation is subsidiary of Multidisciplinary Association for Psychedelic Studies. MAPS was founded by Rick Doblin.*

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Voices: J. D. Vance wouldn’t know what to say to a real Appalachian like me. Ohio deserves better

I sometimes joke that J.D. Vance is my evil twin. Born a year and a half before me, Vance and I are both the grandchildren of Appalachian out-migrants. He is the first in his family to obtain a university degree, and so am I. He grew up about 30 miles from where I grew up in the decaying Rust Belt cities between Dayton and Cincinnati. Jackson, from where his grandmother hailed and from whence J.D. claims his Appalachian identity, is 45 miles from my grandmother’s home town — and where I spent much of my childhood and graduated high school — in Hyden.

Voices: J. D. Vance wouldn’t know what to say to a real Appalachian like me. Ohio deserves better

Related:

J.D. Vance’s First Attempt to Renew Ohio Crumbled Quickly

Video via More Perfect Union

14-Year-Old Speaks Out After Being Denied Medication Because She’s Childbearing Age

Over the weekend, a local news outlet in Tucson, Arizona, reported that a 14-year-old girl had been denied her medication, methotrexate, for her debilitating arthritis and osteoporosis, because methotrexate can possibly induce a miscarriage and the girl is of childbearing age. This comes just after Arizona’s pre-Civil War, total abortion ban took effect at the end of last month.

14-Year-Old Speaks Out After Being Denied Medication Because She’s Childbearing Age

Slava Slush Fund: despite economic crisis, Congress readies $12 billion more for Ukraine + More

U.S. has now allocated over $80 billion to Kiev.

Sure, financial markets and national currencies are imploding worldwide, but the military industrial regime needs to keep churning, and that means pumping more money into the Slava Slush Fund.

Slava Slush Fund: despite economic crisis, Congress readies $12 billion more for Ukraine

Related:

There’s no debating it: Biden will get billions in new Ukraine aid

“Oversight of Ukraine aid is sorely needed,” Julia Gledhill, a defense analyst for the Project on Government Oversight (POGO), tells Responsible Statecraft. “The State and Defense departments are handling billions of dollars in Ukraine funding, but neither have permanent inspectors general in place to investigate and prevent abuse of funds.”

Senate advances spending bill for Ukraine with $12 Billion

After the Senate invoked cloture for the legislative vehicle to carry out the CR, it will now be up for a full vote by the Senate. The House will next vote on it, likely on Friday.

Report: US Preparing $1.1 Billion Arms Package for Ukraine

The weapons package will likely include HIMARS rocket systems, HIMARS ammunition, counter-drone systems, radar systems, training, and technical support.

The arms package is expected to be provided to Kyiv using the Ukraine Security Assistance Initiative (USAI) as opposed to sending the arms directly from US military stockpiles. The USAI allows the Biden administration to purchase military equipment for Ukraine from the US arms industry.

[2017] Why vaccine manufacturers are exempt from liability

In 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA), creating a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related lawsuits and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too difficult and cost prohibitive.

Why vaccine manufacturers are exempt from liability

Prescription Drug Price Reforms Won’t Happen for Years

Prescription Drug Price Reforms Won’t Happen for Years

The two biggest benefits for seniors in the IRA are the Medicare negotiation of certain high-cost prescription drugs, and the $2,000 out-of-pocket cap. But while price negotiations technically start next year, no consumer will see the benefit until the new prices begin in 2026, and even then on only 10 drugs (another 15 are added in 2027 and 2028, rising to 20 by 2029 and subsequent years).

The $2,000 out-of-pocket cap, which is across the board for all seniors, not just on certain drugs, is even worse. That cap doesn’t go into effect until 2025, although out-of-pocket costs get capped at $4,000 in 2024. If there is kind of an explanation for delays in setting up Medicare drug price negotiation, for the out-of-pocket cap there is not. You literally tally up patient out-of-pocket costs, which are fully transparent, until they hit $2,000, and then stop them. Why does this take more than two years to pull off? Medicare itself, the entire program, took only a year to implement.

Other parts of the bill do come online more quickly. The insulin price cap of $35 a month for Medicare recipients starts in 2023, as does free vaccine coverage in Medicare and the rebates on Medicare drugs with price increases above inflation. But the inflation rebate is benchmarked to 2021 prices, locking in those high costs, and just would mute price growth. The real benefits here are Medicare negotiations that lower drug prices, and the cap on all prescription drug costs for seniors. Those are delayed.

It is absolutely insane for a political party to boast that it lowered prices for seniors when the price reductions are years and years down the road. That kind of de facto bait and switch leads to distrust and anger. You’d have thought Democrats would have learned this lesson in the Affordable Care Act, whose major benefits didn’t kick in for four years after passage, a time lag that helped lead to two midterm wipeouts. But here we are again, as Democratic officials tout a drug price reform that isn’t visible to anyone.

That’s not necessarily Democrats’ fault (although they could have ignored the parliamentarian, of course). What is their fault is the failure to immediately make evident the benefits of the policy. Democrats have had a tendency to break faith with their base, to make promises and fail to deliver. Here’s a policy they’ve been promising for nearly two decades, they pass the policy, and they’re going to spend years explaining how the implementation is just around the corner. It comes off as double-talk and toxifies a political brand. And in this case, it was unnecessary.

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Medicare officials say costly Alzheimer’s drug to blame for large monthly jump in premium

Medicare officials say costly Alzheimer’s drug to blame for large monthly jump in premium

The increase guarantees that health care will gobble up a big chunk of the recently announced Social Security cost-of-living allowance, a boost that had worked out to $92 a month for the average retired worker, intended to help cover rising prices for gas and food that are pinching seniors.

Related:

Biogen probes death of Aduhelm user after brain swelling

Cost and controversy are limiting use of new Alzheimer’s drug

How an Unproven Alzheimer’s Drug Got Approved

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

“Safety in a world of user fees” is of paramount concern, concluded Lexchin. That was was back in 2017. Four years on, we are in the biggest health crisis of our lifetimes and the tasks performed by medicines regulators are more important than ever. New experimental vaccines and therapeutic treatments are rolling off the line in record time. But they’re also being authorised in record time — in some cases despite scant evidence of benefits (e.g., Remdesivir). And they’re earning record profits for their manufacturers. At the same time, promising repurposed off-patent medicines that do not offer lucrative financial returns are largely being ignored or are even being demonised by our medicines regulators.