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Yesterday β€” 31 May 2024Main stream

FDA’s review of MDMA for PTSD highlights study bias and safety concerns

By: Beth Mole
31 May 2024 at 19:46
MDMA is now in the FDA's hands.

Enlarge / MDMA is now in the FDA's hands. (credit: Getty | PYMCA/Avalon)

The safety and efficacy data on the use of MDMA (aka ecstasy) for post-traumatic stress disorder therapy is "challenging to interpret," the Food and Drug Administration said in a briefing document posted Friday. The agency noted significant flaws in the design of the underlying clinical trials as well as safety concerns for the drug, particularly cardiovascular harms.

On Tuesday, June 4, the FDA will convene an advisory committee that will review the evidence and vote on MDMA's efficacy and whether its benefits outweigh its risks. The FDA does not have to follow the committee's recommendations, but it often does. If the FDA subsequently approves MDMA as part of treatment for PTSD, it would mark a significant shift in the federal government's stance on MDMA, as well as psychedelics, generally. Currently, the US Drug Enforcement Administration considers MDMA a Schedule I drug, defined as one with "no currently accepted medical use and a high potential for abuse." It would also offer a new treatment option for patients with PTSD, a disabling psychiatric condition with few treatment options currently.

As Ars has reported previously, the submission of MDMA for approval is based on two clinical trials. The first trial, published in Nature Medicine in 2021, involved 90 participants with moderate PTSD and found that MDMA-assisted psychotherapy significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given psychotherapy along with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

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Before yesterdayMain stream

The Deliberation

By: mittens
30 May 2024 at 08:15
After days of testimony and a marathon closing argument from the prosecution, the jury for the Trump hush-money trial begins its second day of deliberations. They have requested a replay of not only some of the crucial testimony, but at least a portion of the hour-long instructions Justice Merchan provided. The specific crime Trump is charged with turns out to be fairly complex, and Lawfare has an explainer.

Google sends DOJ unexpected check in attempt to avoid monopoly jury trial

21 May 2024 at 17:54
Google sends DOJ unexpected check in attempt to avoid monopoly jury trial

Enlarge (credit: picture alliance / Contributor | picture alliance)

Last week, Google sent a cashier's check to the US government that it claimed in a court filing covers "every dollar the United States could conceivably hope to recover" in damages during the Google adtech monopoly trial scheduled to start this September.

According to Google, sending the check moots the government's sole claim for damages, which in turn foils the government's plan to seek a jury trial under its damages claim. While Google disputes liability for any of the government's claims, the payment serves to "prevent the tail from wagging the dog," the court filing said.

It's unclear just how big the check was. The court filing redacted key figures to protect Google's trade secrets. But Google claimed that testimony from US experts "shrank" the damages estimate "considerably" from initial estimates between $100 million and $300 million, suggesting that the current damages estimate is "substantially less" than what the US has paid so far in expert fees to reach those estimates.

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New Yorker on Lucy Letby: Did She Do It?

16 May 2024 at 13:13
The New Yorker takes on the dubious evidence that led to Letby's conviction and the bizarre UK media restrictions that governed coverage of the case. [CW: infanticide] Rachel Aviv's article paints a picture of a neonatal intensive care unit undergoing the same catastrophic deterioration as the rest of the National Health Serviceβ€”a topic the magazine has covered recentlyβ€”and how an especially competent and determined nurse might just end up at the scene of several patients' deaths because she was called in to help on virtually all difficult cases.

The case against her gathered force on the basis of a single diagram shared by the police, which circulated widely in the media. On the vertical axis were twenty-four "suspicious events," which included the deaths of the seven newborns and seventeen other instances of babies suddenly deteriorating. On the horizontal axis were the names of thirty-eight nurses who had worked on the unit during that time, with X's next to each suspicious event that occurred when they were on shift. Letby was the only nurse with an uninterrupted line of X's below her name. She was the "one common denominator," the "constant malevolent presence when things took a turn for the worse," one of the prosecutors, Nick Johnson, told the jury in his opening statement. "If you look at the table overall the picture is, we suggest, self-evidently obvious. It's a process of elimination." But the chart didn't account for any other factors influencing the mortality rate on the unit. Letby had become the country's most reviled womanβ€”"the unexpected face of evil," as the British magazine Prospect put itβ€”largely because of that unbroken line. It gave an impression of mathematical clarity and coherence, distracting from another possibility: that there had never been any crimes at all. Vanity Fair recently published a piece coming from a more pro-guilt perspective, but retracted that article due to the same strange British press laws that somehow prevent any coverage which might doubt the efficacy of the court system or the quality of the prosecution but didn't prevent wall-to-wall coverage alleging Letby's guilt before and during the trial (the best I could do was a Google Drive link to scans of the article; if we can find a better version, I'd ask the mods to add it in here). Especially strange from the New Yorker piece were Letby's attorneys' decisions not to put the NHS on trialβ€”Letby's most obvious trial defenseβ€”and instead to insist, along with the prosecution, that the service was getting along fine. Likewise, not to present a single defense medical expert after months of prosecution medical testimony that was...assailable: The prosecution's pathologist, Andreas Marnerides, who worked at St. Thomas' Hospital in London, wrote that the child had died of natural causes, most likely of pneumonia. "I have not identified any suspicious findings," he concluded. But, three years later, Marnerides testified that, after reading more reports from the courts' experts, he thought that the baby had died "with pneumonia," not "from pneumonia." The likely cause of death, he said, was administration of air into his stomach through a nasogastric tube. When Evans testified, he said the same thing. "What's the evidence?" Myers asked him. "Baby collapsed, died," Evans responded. "A baby may collapse for any number of reasons," Myers said. "What's the evidence that supports your assertion made today that it's because of air going down the NGT?" "The baby collapsed and died." "Do you rely upon one image of that?" Myers asked, referring to X-rays. "This baby collapsed and died." "What evidence is there that you can point to?" Evans replied that he'd ruled out all natural causes, so the only other viable explanation would be another method of murder, like air injected into one of the baby's veins. "A baby collapsing and where resuscitation was unsuccessfulβ€”you know, that's consistent with my interpretation of what happened," he said. When so many of us now work in deteriorating systems, doing two or three times our share of work while other people's lives or livelihoods depend how well we do it, it is especially terrifying, if the New Yorker's take is to be believed, to see a single individual scapegoated and sentenced to life imprisonment for the failures of the system she worked in. Or, if Vanity Fair (and, if Twitter replies are any indication, most of the British public) has the right of it, some justice may have been done.

He only visited the Playboy Mansion to support their journalism

15 May 2024 at 10:09
Perhaps Donald John Trump will have only one criminal trial this year. The prosecution's case in his state trial for using hush money to pay off a porn star to illegally influence his election is finishing with ex-fixer Michael Cohen testifying.

Also: A history of Donald Trump and his associations with the Playboy empire including his soft-porn film. A photo of Donald Trump, his wife, his daughter, Karen McDougal, and three other Playboy bunnies at the Playboy Mansion. He only attended Epstein parties for the scintillating conversation with underaged women.
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