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Saturday, June 3, 2023

Pentagon bans drag shows on military bases

 A day before the Pentagon celebrated the June 1 start of Pride Month, top defense leaders were quietly enforcing a militarywide ban on drag performances.

The move became public after Defense Secretary Lloyd Austin and Joint Chiefs of Staff Chairman Gen. Mark Milley stepped in to stop a drag show at Nellis Air Force Base, Nev., which had been scheduled for Thursday.

In enforcing the ban, which stems from a long-standing Defense Department policy that has not always been applied, critics say the Pentagon appears to have acquiesced to GOP pressure in recent months to cancel those performances at military installations. 

Republican lawmakers, in hearings and letters to the Defense Department, have raged over drag shows and diversity programs, which they claim hurt recruiting efforts and compromise warfighting.

LGBTQ rights groups have slammed the apparent shift from the Pentagon, noting the U.S. has a long history of supporting drag shows going back to at least World War I.

Kelley Robinson, president of the Human Rights Campaign, said Austin has been “unwavering” in supporting LGBTQ groups, but by banning drag shows, he “chose to side with the politics of fear and discrimination peddled by extreme members of Congress.”

The GOP has beamed with approval over the news this week and appears emboldened to press the issue further. 

Rep. Mike Johnson (R-La.) said he was “glad the Pentagon has made clear this shouldn’t be allowed.”

“China is building hypersonic missiles while the U.S. Secretary of Defense is being forced to explain why there are drag shows on our military bases,” Johnson said in a statement. “The fact that these events were scheduled once again calls into question the priorities of our military’s leadership.”

The enforcement first came to light after NBC News reported on the drag show cancellation at Nellis Air Force Base. The Air Force pointed to recent congressional testimony from Austin in explaining the scrapped plans — the defense chief said drag events are “not something that the department funds.”

Citing a policy on standards of conduct and ethics regulation, Pentagon deputy press secretary Sabrina Singh said this week “certain criteria” must be met for nongovernment individuals and organizations using Defense Department facilities and equipment.

“Hosting these types of events in federally funded facilities is inconsistent with regulations regarding the use of DoD resources,” she said in a statement regarding the Nellis Air Force Base drag show cancellation. 

“We are proud to serve alongside any and every young American who takes the oath that puts their life on the line in defense of our country. Service members and their families are often involved in a host of special interest activities related to their personal hobbies, beliefs, and backgrounds.”

A White House official referred questions about the policy to the Pentagon.

Robinson of the Human Rights Campaign noted the Pentagon’s move comes as LGBTQ Americans are facing growing threats and fears of violence. 

“For decades, our community has fought for our right to exist without shame or exception, yet the Secretary’s decision to ban an event that has happened in prior years reinforces false tropes about LGBTQ+ culture,” Robinson said in a statement

“At a time when we are under attack, the Pentagon is ceding to extremist forces focused on taking away our rights —leaders responsible for national defense ought to do better. 

The event’s cancellation appears to be the first time senior Defense officials have enforced the policy, as Nellis AFB hosted a Pride Month drag show in June 2021.

Yeoman 2nd Class Joshua Kelley, a former Navy digital ambassador, performed in drag under the name “Harpy Daniels” while serving on the aircraft carrier USS Ronald Reagan from 2016 to 2018. Kelley also received intense backlash from the GOP for appearing as a drag queen.

Other drag shows and drag-themed events have also taken place on military installations across the country in previous years.

When asked why the ban has now been applied, the Pentagon did not respond.

The action seems to stand in contrast to Austin’s official statement to mark the start of Pride Month, released Thursday, in which he said he believes “that the story of America should be one of widening freedom, not deepening discrimination” and vowed to ensure LGBT individuals could continue to serve.

“This Pride Month, we honor the service, commitment, and sacrifice of the LGBTQ+ Service members and personnel who volunteer to defend our country,” Austin states. “Their proud service adds to America’s strength.”

Some GOP lawmakers still aren’t satisfied with the ban on drag shows on military bases.

Rep. Mark Alford (R-Mo.), a frequent critic of diversity, equity and inclusion programs at the Pentagon, said the “decision to end drag shows on military bases is a positive first step” but added he would “not stop until all wokeness is weeded out of our military.”

“Why were they happening in the first place?” Alford said in a statement. “Earlier this year, Secretary Austin came before the House Armed Services Committee and told us that drag shows were not taking place on U.S. military installations. Clearly, that was not true.”

Rep. Matt Gaetz (R-Fla.) also hailed the decision, calling it a “huge victory.”

“Drag shows should not be taking place on military installations with taxpayer dollars PERIOD!” he tweeted.

Gaetz had questioned Austin and Milley about “drag queen story hours” on U.S. military installations in the U.S. and in Germany during a March House Armed Services Committee hearing. 

Milley responded to the questioning that he was not aware of the events and wanted to “take a look at those, because I don’t agree with those.”

Austin replied that the event is “not something that the department funds.”

The comments from the nation’s top defense officials were scooped up by the GOP and conservative media.

The testimony at that hearing appears to have marked a shift in the enforcement of ethics and standards of conduct policies for drag shows on military installations.

An Air Force official confirmed to The Hill that “consistent with Secretary Austin’s congressional testimony, the Air Force will not host drag events at its installations or facilities.”

“Commanders have been directed to either cancel or relocate these events to an off-base location.”

The March hearing was followed by a House Republican letter to Austin in May, led by Alford, demanding he “put an end to any drag shows and any ‘drag queen influencers’ performing in our military” and instead focus on “patriotism” and pride in “American greatness.”

“We’re at a time where America’s youth has very little desire to serve and protect our nation,” the House Republicans wrote at the time. “The Navy’s decision to use drag queens as a recruitment tool is outrageous and a disgrace to those who have previously served.”

Defense officials were also facing pressure from the Senate side. 

Sen. Steven Daines (R-Mont.) last month introduced legislation to ban Pentagon funding for drag shows on military bases.

Daines had expressed outrage at previous drag show events in Virginia and Nevada as well as a 2021 event in his home state that reportedly included a drag queen story hour for children.

The Pentagon’s retreat from the culture wars this Pride Month also appeared to extend to social media. 

The Navy’s official Instagram and Twitter accounts removed Thursday posts celebrating the start of Pride Month.

The Instagram post depicted a fighter jet with the LGBTQ+ flag colors in its wake, but by Friday morning, the image was gone. 

In a statement to The Hill, a Navy spokesperson acknowledged the original posts but would not say why or when they were removed.   

“The US Navy posted graphics in support of the start of Pride month to honor the service, commitment, and sacrifice of the LGBTQ+ Service members and personnel who volunteer to defend our country,” they said in a statement. 

The Modern Military Association of America, the nation’s largest organization of LGBTQ+ service members, military spouses, veterans and their families, said in a statement to The Hill they were “deeply troubled” by the drag ban and were “determining next steps regarding communications with the Pentagon and Biden administration about this issue.”

The group pointed out that drag performances have long been a part of military history, including during WWII, when all-male theater performances were produced with soldiers dressing in drag to impersonate women. 

The group said it was “concerned that censorship of LGBTQ-friendly events sends the message to LGBTQ+ members of the armed forces that wearing their preferred clothing or acting in a manner different from the gender assigned to them at birth is unacceptable.”

It noted that nearly 80,000 lesbian, gay and bisexual people were currently in active service, along with another 15,000 transgender people. 

“Ensuring our ranks reflect the diversity of the American people is essential to morale and cohesion,” it added. 

https://thehill.com/policy/defense/4032443-pentagon-bans-drag-shows-on-military-bases-after-gop-pressure/

Can the Shingles Vaccine Prevent Dementia?

 A new paper provides good evidence that the shingles vaccine can prevent dementia, which strongly suggests that some forms of dementia are caused by the varicella zoster virus (VZV), the virus that on initial infection causes chickenpox. The data come from Wales where the herpes zoster vaccine (Zostavax) first became available on September 1 2013 and was rolled out by age. At that time, however, it was decided that the vaccine would only be available to people born on or after September 2 1933. In other words, the vaccine was not made available to 80 year olds but it was made available to 79 year and 364-day olds. (I gather the reasoning was that the benefits of the vaccine decline with age and an arbitrary cut point was chosen.)

The cutoff date for vaccine eligibility means that people born within a week of one another have very different vaccine uptakes. Indeed, the authors show that only 0.01% of patients who were just one week too old to be eligible were vaccinated compared to 47.2% among those who were just one week younger. The two groups of otherwise similar individuals who were born around September 2 1933 are then tracked for up to seven years, 2013-2020. The individuals who were just “young” enough to be vaccinated are less likely to get shingles compared to the individuals who were slightly too old to be vaccinated (as one would expect if the vaccine is doing it’s job). But, the authors also show that the individuals who were just young enough to be vaccinated are less likely to get dementia compared to the individuals who were slightly too old to be vaccinated, especially among women. A number of robustness tests finds no other sharp discontinuities in treatments or outcomes around the Sept 2, 1933 cut point.

The following graph summarizes. The top left panel shows that the cutoff led to big differences in vaccine uptake, the top right panel shows that there was a smaller but sharp decline in dementia in the vaccinated group. The bottom panel shows that was no discontinuity in a variety of other factors.

Read the whole thing.

Alex Tabarrok is Bartley J. Madden Chair in Economics at the Mercatus Center and a professor of economics at George Mason University. Along with Tyler Cowen, he is the co-author of the popular economics blog Marginal Revolution and co-founder of Marginal Revolution University. He is the author of numerous academic papers in the fields of law and economics, criminology, regulatory policy, voting theory and other areas in political economy. He is co-author with Tyler of Modern Principles of Economics, a widely used introductory textbook.

https://marginalrevolution.com/marginalrevolution/2023/05/does-the-shingles-vaccine-prevent-dementia-yes.html

Scientists Gave People Psychedelics—and Then Erased Their Memory

 IN A HOSPITAL room in Madison, Wisconsin, Dave lay on a bed, looking at the trim around the ceiling. An air vent caught his eye. The sheen of metallic grate turned into pointed swords, and his mind filled with thoughts of Japanese martial arts and sword fighting. A few bright colors emerged, in contrast to the sanitized neutrals of the medical setting, and he heard notes of instrumental music. That’s all he remembers after receiving psilocybin, the active ingredient in magic mushrooms—though his trip lasted hours. (Dave requested a pseudonym because he worried that public knowledge of him taking psychedelics could hurt him professionally.)

During the session, researchers asked what he was thinking and feeling, and he apparently had “a long conversation about those points, of which I have no recollection at all,” he said.

It’s not that his trip wasn’t memorable. Dave’s memories were intentionally erased, enough that he recalls “probably not even 10 percent” of the trip. He was also injected with midazolam, a sedative that can be used to produce amnesia. 

His experience—part of a pilot study involving eight people from the University of Wisconsin–Madison Transdisciplinary Center for Research in Psychoactive Substances—proved that it’s possible to combine these two drugs to give someone a close-to-normal mushroom trip, and then use the midazolam to wipe their memory. Why make someone trip, only to take away their memory of it?

Typically, when scientists try to isolate a drug’s effects, they do so with double-blind randomized clinical trials, or RCTs, in which participants (and their doctors) aren’t sure whether they received a drug or placebo. But “nobody’s going to confuse 200 micrograms of LSD for placebo,” said Balázs Szigeti, a postdoc at the Center for Psychedelic Research at Imperial College London. It can be painfully obvious whether someone has taken an active drug or not.

Psychedelic drugs have strong and unique effects, and, to complicate matters further, they are heavily influenced by context, such as a person’s mindset, environment, and beliefs. In other words, people's expectations about what happens on psychedelic drugs might play a role in what they experience. These problems have haunted the study of psychedelics since the first wave of research in the 1950s, and the Wisconsin study is a recent attempt to answer this enduring question: How much does a person’s subjective experience and expectation of a psychedelic trip, as opposed to only the drug’s chemical effects on the brain, influence the drug’s ability to alleviate conditions like depression, addiction, or post-traumatic stress disorder? Now that psychedelics are being noticed by federal regulators and the public, scientists are again asking: What’s the best way to study these compounds in order to truly understand their effects?

THE FIRST PERSON to use “blinding,” a crucial part of an RCT, was probably a psychiatrist named William Rivers. Blinding means that patients are randomly assigned into groups where some get an active drug and others get a placebo, and they’re supposed to be ignorant to which group they are in. This ensures that both patients and practitioners don’t introduce bias into the study and affect outcomes.

In 1906, Rivers gave himself either an alcoholic or non-alcoholic drink made by a colleague, with the flavor masked so he couldn’t tell which was which. Then he observed how the drinks affected how easily his muscles became tired, noting that previous work on the same topic may have overestimated the effects of alcohol, because people knew whether they were drinking. 

It’s now well established that skipping the blinding in studies can lead to an overestimation of a treatment’s effects. Yet blinding is not required for drug approval from the US Federal Drug Administration (FDA). And the unique nature of psychedelics means that true blinding might be close to impossible.

These challenges have even led Field Trip Health’s medical director, Ben Medrano, to claim that psychedelic treatments would “never be easily verifiable in a laboratory or a double-blind study.” (Field Trip recently had to file for creditor protection to restructure and sell assets to avoid bankruptcy, and closed several of its ketamine clinics.)

It’s an ironic position to take considering that psychedelic research has been vying for legitimacy for decades, and has just recently started to attain it. In the past 10 years, clinical trials on psychedelics have started to regularly appear in high-impact academic journals like The New England Journal of Medicine and Nature, and in 2021, the National Institute of Health announced the first government grant for psychedelic research in half a century. Now, psychedelics have been heralded as an “emerging new paradigm” in psychiatry. Drugs like psilocybin and MDMA are in Phase 3 trials, gathering data to submit to the FDA for approval.

To say that RCTs will inevitably falter in the face of psychedelics is like condemning a sprinter to stumble right out of the starting blocks. Yet, intentionally or not, Medrano was alluding to a very real problem: The way psychedelic RCTs have been conducted so far have not addressed the role of someone’s beliefs and predictions, alongside their knowledge of taking a psychedelic. 

None of the recent landmark psychedelic trials have officially reported blinding. In 2021, University of Auckland neuropharmacologist Suresh Muthukumaraswamy and colleagues looked at placebo-controlled RCTs of ketamine for the treatment of major depressive disorder and found that of 43 studies, none had measured what people expected to happen in the trial beforehand, or their “pretreatment expectancy.” Five measured blinding, but none of them used blinding measures or scales that already exist. Only one study said that they successfully maintained the blind.

In a more recent analysis from May, researchers looked at all the randomized trials of psychedelics in humans conducted from 1940 through May 2020, specifically focusing on blinding. While 94 percent of the studies claimed to be blinded, only 17 percent included any blinding assessments—and only eight of the 14 studies that included them actually used those measurements.

Meanwhile, in the studies of esketamine, a different chemical formulation of ketamine, the placebo was made to taste bitter to emulate the taste of esketamine. Still, no one checked to see whether the esketamine placebo had effectively tricked people; the data was nonetheless submitted to the FDA and approved for treatment-resistant depression, because even if the FDA requires a blinded placebo group, it does not require any confirmation that blinding was successful.

Because of this challenge in study design, all the effect sizes from psychedelic trials so far could be inflated to an unknown degree. People in nonactive drug arms of trials could be suffering harms—called the nocebo effect—from knowing that they’re not receiving an active treatment, thus making the active treatment look even better. “People’s expectations about treatments are really important and really powerful,” said Jacob Aday, an experimental psychologist at the University of California, San Francisco, who coauthored a paper on expectation and psychedelic trials last year. “There probably hasn’t been a true double-blind study actually conducted with psychedelics.” 

IN THE WORLD of psychedelics, this is a moment of déjà vu. The decline in LSD research in the 1960s, often blamed on public backlash to recreational use, might be better explained by the difficulty of studying psychedelics through typical study designs.

Before 1962, studies on LSD rarely had control groups, and focused on small groups of patients who knew they were taking a hallucinogenic drug. By 1970, the FDA had begun requiring that new drug applications submit RCT results. (These amendments were developed in response to the thalidomide tragedy, when a widely used drug led to severe birth defects in thousands of children.) Psychedelic researchers then faced the same challenge that scientists are dealing with now: How do you fit psychedelics into a study design that seems unable to contain it? 

Some studies that focused on correctly executing an RCT didn’t achieve positive results, like one double-blind study from 1969 on LSD treatment for alcoholism. All the patients expected to receive LSD, but some got a stimulant or tranquilizer as active placebos. The trial didn’t include any psychotherapy, and the LSD did no better than the control drugs. Historian Matthew Oram has argued that the general move to focus on clinical trial design came at the cost of focusing on the therapy that went alongside the drug treatment—leading to a lesser intervention effect.

Then, in 1970, US president Richard Nixon signed the Controlled Substances Act (CSA), prohibiting many psychedelics in the country, and research essentially came to a standstill. The issue of how to study psychedelics in a manner that could provide the right data for federal regulators remained unresolved.

EVERY MONTH, INTERDISCIPLINARY researchers get together on Zoom to worry about psychedelic trial design. The group, called Reimagining Psychedelic Trials, was started by Tehseen Noorani, an anthropologist at Durham University. 

“RCTS are supposedly what the regulators want, which I think is also a bit of a farce, because I’m not sure ‘the regulators’ are one thing and that they want something clear,” Noorani said. “Rather, we’re all trying to figure it out, which is why I think this is so ripe for a kind of evolution of methodology across the sector.”

I visited the working group in February, and we discussed how it might be possible to measure the effects of media consumption on the expectations of clinical trial participants—if the type and amount of psychedelic journalism a person reads has any association with outcomes (an issue I have vested interest in). I learned quickly that there are no easy solutions. 

As Noorani has written, expectations are all around us. It’s not just what we read, but the communities we live in and the cultural values we hold. We are immersed—like the fish parable that David Foster Wallace once opened a graduation speech with: An older fish says to two younger fish, “Morning, boys. How’s the water?” The two young fish swim on for a bit before one of them looks over at the other and goes, “What the hell is water?”

The anthropologist Anthony Wallace noticed in the 1950s that Euro-American subjects who took mescaline in the lab had very different experiences than Native Americans who ate peyote buttons as part of religious ceremonies. He suggested the concept of a “culture-controlled trial,” which would test the same drug and the same dose but in different social and cultural contexts. “There is always hidden machinery and circuitry that is going on, and we’re not describing it,” University of Auckland’s Muthukumaraswamy said. “And there are all these hidden interactions that, frankly, we’re brushing under the carpet.” 

These factors make the efficacy of a medical intervention “unstable over time and potentially at the whim of social zeitgeist.” Noorani is also credited with the term “the Pollan effect,” or the impact that Michael Pollan’s book How to Change Your Mind has had on public perception of psychedelics and, inadvertently, the expectations of clinical trial participants. Public perceptions of psychedelics weasel their way into trial results through placebo effects and people’s expectations, and those trial results then further impact public perceptions. 

There’s no agreement on the best way to find out whether the study participants or researchers can guess what group they’re in, or what their expectations are going into the study. But one way to start addressing this problem is simply to start checking. “Everybody pretends that if you have a placebo control group, that is sufficient to control for the placebo effect,” Imperial College London’s Szigeti said. “That’s not exactly true. You also need to show that blinding worked as intended, some empirical evidence.”

Szigeti developed a Correct Guess Rate Curve to assess the quality of blinding—how often people guess the treatment correctly. If there are two treatments to choose from and people are guessing randomly, the CGR should be around 50 percent. For classic antidepressants, it’s somewhere between 60 to 70 percent. For microdosing, it’s around 70 to 75 percent. “When it comes to macro-dosing, it’s probably around 95 percent,” Szigeti said.

But when Szigeti approached the mental health company Compass Pathways about helping them to include blind breaking and expectancy measures in their upcoming Phase 3 trials of psilocybin for treatment-resistant depression, they said no. “Costs for them would be basically zero, just a few questionnaires here and there,” Szigeti said. “I even emphasized that I would be happy to analyze it separately from the main trial, not to mess with their business.” They still turned him down.

ACTIVE PLACEBOS ARE one way to make a trial participant uncertain about what drug they’ve taken. It’s a substance with some kind of impact on the body or mind that could confuse a person into thinking they’ve taken a psychedelic, and lead them to have the same kinds of expectations without the effects of the drug being studied, since it’s another drug altogether. But they don't always guarantee that people won’t be able to guess what treatment group they’re in. 

A study from 1966 on LSD for alcoholism used a 60-milligram dose of ephedrine sulfate as an active placebo. In 19 of the 20 drug sessions, the therapists correctly guessed which drug the patients got. Famously, in the Good Friday Experiment, divinity school students took either psilocybin or niacin, a B vitamin with some physiological effects, like facial flushing. “Before long, it became clear which participants had been assigned to which condition, as those in the psilocybin group had intense subjective reactions and often spiritual experiences, whereas the niacin group ‘twiddled their thumbs’ while watching on,” Aday wrote.

Newer studies have tried harder to make their active placebos convincing. A study from 2021 made a fake version of ayahuasca using “a mixture of cocoa powder, unspecified vitamins, turmeric powder, quinoa, traces of coffee, and potato flour.” They fooled a few people, but the majority still correctly guessed which treatment arm they belonged to. 

At the end of Muthukumaraswamy and his colleague’s recent study on antidepressant responses to ketamine, which used an active placebo called remifentanil, 27 people were asked to guess which day they’d received ketamine. They guessed correctly 88 percent of the time. 

It’s also not just the study’s active placebo and design that matter, but also how the patients are told about the study and the information sheets they read before and after—all elements that are rarely reported and shared. “We just don’t see this published with their trials,” Muthukumaraswamy said. “It should be compulsory. We should be seeing what they tell the patients, because that is what shapes their expectancy.” 

Rotem Petranker, the director of the Canadian Centre for Psychedelic Science, agreed that these contextual factors are critical, including the therapeutic element. “That, to me, seems to be the most significant extra pharmacological factor,” he said. "And we basically know nothing about it."

IN THE END, the placebo-controlled trial just may not be the best fit for studying all aspects of psychedelics. There are other study design components, some that Muthukumaraswamy evaluated in his paper, that could work better. 

One way to reduce expectations would be to completely conceal the dose or treatment from study participants—giving them little information to form expectations around. Another could be to conduct a “deceptive trial” in which people are told there’s an active group, but in reality, everyone gets a placebo. Both designs raise ethical concerns about misleading patients. Reformatting a consent form to list all potential drug effects could also undermine expectation.

There’s also an option called “pragmatic clinical trial design,” which measures a treatment’s overall effectiveness rather than distinguish how or why it’s different from a placebo group. This design would accept that expectation and placebo are playing a role in how people feel, and would simply accept it so long as people’s depression scores decrease. 

In one example of a well-executed study design, Harriet De Wit and her team gave patients either MDMA or methamphetamine and had them report how pleasant touch felt. Participants were asked to guess which drug they got—and the people who believed they got MDMA but really got methamphetamine were used as the control group. “They [had] all the expectations baked in, but they actually didn’t get the drug,” says Boris Heifets, an anesthesiologist and neuroscientist at Stanford University. That group didn’t experience the same level of pleasantness to touch as those who got MDMA—suggesting that the effect on touch is specific to MDMA.

In a recent preprint study led by Heifets, people with moderate to severe depression were given either ketamine or a placebo during surgical anesthesia. The differences were not clinically significant between the groups—they all started feeling a lot better. Heifets and his colleagues are preparing to do a similar study with anesthesia and psilocybin, and the team at the University of Wisconsin–Madison will be probing the effects of psilocybin administered during deep sleep stages.

There are pros and cons to all of these models, and of course, the FDA still accepts only the RCT as data for approval. But experts say that other designs, even if not submitted to federal agencies, could help us learn more about psychedelics and how they work.

“I think placebo-controlled trials are definitely overrated, particularly in psychopharmacology,” said Nicolas Langlitz, an associate professor of anthropology at the New School for Social Research who leads a psychedelic humanities lab. “I don’t think there is a superior method to replace them, but if that’s the gold standard, then you should also have a silver standard and a bronze standard, and those should also provide interesting information.” 

Anecdotal or open-label data may be messy and dirty, but if we ignore it because it’s not a randomized placebo-controlled trial, Langlitz said, we could miss out. “I would really urge people to pluralize,” he said. “And to have more of a conversation about the epistemological costs and benefits of different approaches.”

Because expectations may be one of the key ingredients in psychedelic therapy, instead of doing away with them, we should learn about them and their role in order to better manipulate them.

In Heifets’ ketamine and anesthesia study, for instance, there was one woman who received the placebo while under anesthesia, remembered nothing, and felt a remarkable improvement—from just the expectation that she got ketamine. “I was taking six college classes while waiting for surgery,” she reported after. “I was able to take all six exams from the hospital bed, passed them all with As and Bs.”

“The main thing that I take away from it isn’t that ketamine doesn’t work,” Heifets said. “What it does mean is this incredible power of suggestion, expectation, planning, and thinking about the future, and ceding control to the care of others for a vulnerable period. Maybe it doesn’t matter whether you’re there for it or not.”

Dave was a little bummed that he doesn’t remember his trip. It was his first time taking psilocybin, and it vanished somewhere into the recesses of his midazolam-altered mind. After his forgotten trip, Dave didn’t notice any differences in his day-to-day life. There are plenty of caveats—Dave isn’t depressed, so his psilocybin experience may not have had much of a needle to move—but it’s still not clear what the most important part of a psychedelic experience is in regards to lasting change: the experience, the therapy, the biology, the expectation, or all of the above.

“None at all,” he said. “I could not tell you any difference it made.”

https://www.wired.com/story/psychedelics-study-design-research-rcts/

Complying, Not Defying: Twitter And The EU Censorship Code

 by 'Robert Kogon' via The Brownstone Institute,

So, word has it that Twitter has withdrawn from the EU’s Code of Practice on Disinformation, a fact that appears only to be known thanks to a couple of pissy tweets from EU officials. I cannot help but wonder if this is not finally Elon Musk’s response to the question I asked in my article here several weeks ago: namely, how can a self-styled “free-speech absolutist” be part of a “Permanent Task-Force on Disinformation” that is precisely a creation of the EU’s Code?

But does it matter? The answer is no. The withdrawal of Twitter’s signature from the Code is a highly theatrical, but essentially empty gesture, which will undoubtedly serve to shore up Musk’s free speech bad-boy bona fides, but has virtually no practical consequences. 

This is because: (1) as I have discussed in various articles (for instance, here and here), the effect of the EU’s Digital Services Act (DSA) is to render the hitherto ostensibly voluntary commitments undertaken in the Code obligatory for all so-called Very Large Online Platforms (VLOPs) and (2) as discussed here, the European Commission just designated a whole series of entities as VLOPs that were never signatories of the Code.

Twitter is thus in no different a position than Amazon, Apple and Wikipedia, none of which were ever signatories of the Code, but all of which will be expected by the EU to comply with its censorship requirements on the pain of ruinous fines. 

As EU officials like to put it, the DSA transformed the “code of practice” into a code of conduct: i.e. you had better do it or else.

Compliance is thus not a matter of a signature. The proof of the pudding is in the eating. And the fact of the matter is that Musk and Twitter are complying with the EU’s censorship requirements. Much of the programming that has gone into the Twitter algorithm is obviously designed for this very purpose.

What, for instance, are the below lines of code?

They are “safety labels” that have been included in the algorithm to restrict the visibility of alleged “misinformation.” Furthermore – leaving aside the handy “generic misinfo” catch-all – the general categories of “misinformation” used exactly mirror the main areas of concern targeted by the EU in its efforts to “regulate” online speech: “medical misinfo” in the context of the COVID-19 pandemic, “civic misinfo” in the context of issues of electoral integrity, and “crisis misinfo” in the context of the war in Ukraine.

Indeed, as Elon Musk and his lawyers certainly know, the final version of the DSA includes a “crisis response mechanism,” (Art. 36) which is clearly modeled on the European Commission’s initially ad hoc response to the Ukraine crisis and which requires platforms to take special measures to mitigate crisis-related “misinformation.” 

In its January submission to the EU (see reports archive here), in the section devoted precisely to its efforts to combat Ukraine-war-related “misinformation,” Twitter writes (pp. 70-71): 

“We … use a combination of technology and human review to proactively identify misleading information. More than 65% of violative content is surfaced by our automated systems, and the majority of remaining content we enforce on is surfaced through regular monitoring by our internal teams and our work with trusted partners.”

How is this not compliance? Or at least a very vigorous effort to achieve it? And the methodology outlined is presumably used to “enforce on” other types of “mis-“ or “disinformation” as well.

Finally, what is the below notice, which many Twitter users recently received informing them that they are not eligible to participate in Twitter Ads because their account as such has been labeled “organic misinformation?”

Why in the world would Twitter turn away advertising business? The answer is simple and straightforward: because none other than the EU’s Code of Practice on Disinformation requires it to do so in connection with the so-called “demonetization of disinformation.” 

Thus, section II(d-f) of the Code reads:

(d) The Signatories recognise the need to combat the dissemination of harmful Disinformation via advertising messages and services.

(e) Relevant Signatories recognise the need to take granular and tailored action to address Disinformation risks linked to the distribution of online advertising. Actions will be applicable to all online advertising.

(f) Relevant Signatories recognise the importance of implementing policies and processes not to accept remuneration from Disinformation actors, or otherwise promote such accounts and websites.

So, in short, vis-à-vis the EU and its Code, Twitter is complying, not defying. Removing Twitter’s signature from the Code when its signature is no longer required on the Code anyway is not defiance. Among other things, not labeling content and/or users as “misinformation,” not restricting the visibility of content and/or users so labeled, and accepting advertising from whomever has the money to pay would be defiance.

But the EU’s response to such defiance would undoubtedly be something more than tweets. It would be the mobilization of the entire punitive arsenal contained in the DSA and, in particular, the threat or application of the DSA fines of 6 percent of the company’s global turnover.

It is not enough to (symbolically) withdraw from the Code of Practice to defy the EU. Defying the EU would require Twitter to withdraw from the EU altogether.

https://www.zerohedge.com/political/complying-not-defying-twitter-and-eu-censorship-code

Conservatives' Boycotts Wipe Billions From Target, Bud Light Valuations, More Brand Battles Loom

 by Naveen Athrappully via The Epoch Times (emphasis ours),

Major brands such as Bud Light and Target, among others, are facing immense backlash from supporting LGBTQ causes, with the market capitalization of the firms crashing by double digits in recent weeks.

Stores of Target were boycotted after the retail giant rolled out its Pride collection at the beginning of May, including some items targeted at children. Between May 1 and May 30, Target’s market capitalization fell from $72.52 billion to $61.78 billion—a decline of 14.80 percent. Bud Light became a target after partnering with transgender social media personality Dylan Mulvaney in a promotional campaign in April. Between April 3 and May 30, the market cap of Anheuser-Busch, which owns Bud Light, fell from $132.06 billion to $108.19 billion—a decrease of over 18 percent.

Target shares were trading at $130.93 as of 06:07 EDT, June 1, down 13.71 percent year to date and at a fresh 52-week low. It is the stock’s longest losing streak since November 2018. Shares of Anheuser-Busch Inbev SA were trading at €49.97, down 12.18 percent for the year.

In addition to Target and Bud Light, several other companies, including PetSmart, Chick-fil-A, and Walmart, are also now facing boycott calls due to their endorsement of the LGBTQ agenda.

A major factor enticing brands to increasingly promote transgender ideologies is an attempt to score points on environmental, social, and governance (ESG) standards used by several high-profile investors.

Target

Target rolled out its Pride collection at the beginning of the month, offering over 2,000 products, including clothing, books, home furnishings, and calendars, among others. Some of the items were targeted at children.

For example, books for kids aged 2–8 had titles like “Pride 1,2,3,” “Bye Bye, Binary,” and “I’m Not a Girl.” Target also suggested “The Pronoun Book” to kids aged 0–3. In home décor, Target offered mugs labeled “Gender Fluid.” It also offered transgender swimsuits for adults with a “tuck-friendly” feature.

The company’s actions attracted a lot of negative reactions online, eventually leading to a boycott call. The firm then decided to remove some of the controversial items.

Target’s 2022 ESG report shows that at least 51 percent of its suppliers are “owned, controlled, and operated by women, BIPOC, LGBTQIA+, veterans, or people with disabilities.” In addition, 59 percent of their Pride Month assortment was created by LGBT creators and brands.

Target has also donated $2.1 million to New York City-based Gay, Lesbian and Straight Education Network (GLSEN), an activist group that puts LGBTQ-themed books in K–12 school libraries and encourages teachers to discuss sex and gender with kids.

Bud Light

In April, Anheuser-Busch sent custon Bud Light beer cans to Mulvaney featuring the trans-activist’s face, a move that was criticized as pushing the transgender agenda. The can was created to celebrate a full year of Mulvaney transitioning to “girlhood.” In the ad, Mulvaney is shown promoting Bud Light drinks with the hashtag #budlightpartner.

As the promotional campaign went viral, criticism started to pour in. Mike Crispi, a podcast host and former Republican New Jersey primary candidate for Congress, called for a boycott. “Boycott Bud Light and NEVER DRINK IT AGAIN EVER,” he said in a tweet on April 3.

The campaign has been devastating for the company’s sales numbers.

Data by Bump Williams Consulting and Nielsen IQ reported by the New York Post showed that sales of Bud Light fell by 25.7 percent for the week ended May 20.

As for ESG policies, Anheuser-Busch’s 2022 ESG report (pdf) shows that the company has created employee resource group (ERG) toolkits focusing on “LGBTQ+, gender, and racial equity.”

PetSmart

Pet products retailer PetSmart faced backlash for its “You Are Loved” collection that was launched just days before the June Pride Month.

The collection featured rainbow-colored toys, clothes, and other items like aquarium ornaments and dog bandanas that had the words “pride vibes” emblazoned on them.

The company’s offerings for dogs include a Pride dog bikini. For cats, rainbow-colored collars and tents are on offer. PetSmart provides “Pride wings” costumes and “Pride vibes” tank tops for reptiles.

Similar to Target, PetSmart also carries a partnership with GLSEN, having made contributions totaling $600,000—with $200,000 made this year alone.

Chick-Fil-A

Fast-food chain Chick-fil-A came under recent scrutiny after the firm was discovered to have hired a vice president of “diversity, equity, [and] inclusion,” or DEI.

“We have a problem,” Joey Mannarino, a conservative host highlighting Chick-fil-A’s prior announcement, wrote on Twitter on May 30. “Chick-fil-A just hired a VP of Diversity, Equity and Inclusion. This is bad. Very bad. I don’t want to have to boycott. Are we going to have to boycott?”

“Chick-fil-A isn’t the Lord’s Chicken anymore … it’s the Woke Chicken … Funding ties also to BlackRock and Vanguard in addition to hiring for DEI to up their ESG scores,” Morgonn McMichael, a contributor at Turning Point USA, said in a June 1 tweet.

Chick-fil-A used to support organizations perceived as anti-LGBTQ. But in 2019, the company changed its stance and said that it would extend support to other charities. As part of the restructure, Chick-fil-A stopped donating to the Salvation Army and the Fellowship of Christian Athletes (FCA).

Walmart

After Target, Walmart is another retailer under scrutiny for its LGBT support. The company’s July 2022 ESG report states that it conducts an “inclusive sourcing” program for LGBTQ groups. “For our U.S. businesses, we sourced more than $13.3 billion in goods and services from approximately 2,600 diverse suppliers.”

Walmart received a full 100 points on The Human Rights Campaign’s Corporate Equality Index (CEI). In order to obtain a perfect CEI score, an organization has to donate to LGBTQ causes as well as refuse to donate to non-religious organizations that oppose such causes. The organization must also support gender transitioning.

In 2021, Walmart donated $500,000 to PFLAG, the largest organization in the United States that advocates for LGBTQ causes.

Walmart is also offering Pride products. A controversial product being offered by the company is a “breathable” chest binder aimed at “trans, lesbian, and tomboys.” The binder, offered online, features pictures of a young girl modeling the product.

GLSEN

GLSEN, the organization to which Target and PetSmart made donations, has a “Rainbow Library” program under which the nonprofit has sent more than 46,000 “LGBTQ+ affirming K-12 books” to over 4,600 schools across the nation. GLSEN also encourages teachers to incorporate gender and sex discussions in topics like mathematics.

Among the list of books that GLSEN wants elementary school students to read is “When Aidan Became a Brother,” which is a story about a couple who “fixed the parts of life that didn’t fit anymore” after their daughter told them she “felt more like a boy.”

https://www.zerohedge.com/political/conservatives-boycotts-wipe-billions-target-and-bud-light-valuations-more-brand-battles

ASCO: Bayer Vitrakvi Long-Term Efficacy and Safety Profile in NTRK Gene Fusion Cancer, Across Solid Tumors

  • Post-hoc subgroup analyses of adult patients (n=180) with TRK fusion cancer across 24 different tumor types, including patients with central nervous system (CNS) metastases (n=22), were presented. All efficacy assessments were by IRC.1
  • Long-term follow-up of subgroup analyses of patients with advanced TRK fusion lung cancer (n=30), including those with CNS metastases (n=12), were also presented.2
  • Additionally, separate subset analyses of three clinical trials evaluating patients with NTRK gene fusion thyroid cancer (n=30) were presented.3 

Neurocrine: INGREZZA® (valbenazine) Capsules Data on Tardive Dyskinesia Improvement

  Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a meta-analysis of three long-term studies evaluating INGREZZA® (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas.

The analysis of the three studies (KINECT 3, KINECT 4, and J-KINECT) demonstrated that treatment with once-daily INGREZZA (40 mg or 80 mg) resulted in substantial and sustained TD improvement through week 48 as measured by the Abnormal Involuntary Movement Scale (AIMS) total score, with no meaningful differences between study completers taking antipsychotics at baseline (AP+) and those who were not (AP-).

Upon withdrawal of INGREZZA, both subgroups experienced a return toward baseline severity of TD symptoms, demonstrating the potentially persistent nature of TD, even in patients no longer taking antipsychotic therapy. Researchers concluded that continuous treatment with INGREZZA to manage TD may be warranted irrespective if they were on concurrent antipsychotic therapy.

"TD may persist even after patients are no longer taking antipsychotic therapy," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "These data from three long-term studies reinforce the continuing value of INGREZZA in TD management, regardless of antipsychotic status."

https://www.biospace.com/article/releases/neurocrine-biosciences-presents-ingrezza-valbenazine-capsules-data-on-tardive-dyskinesia-improvement-regardless-of-baseline-antipsychotic-use-at-2023-psych-congress-elevate/