AwesomeCapital

Monday, September 2, 2024

Hamas taunts slain hostages’ kin with video of captives before death, promises ‘last messages’

Hamas on Monday taunted kin of the six hostages found slain in a Gaza tunnel by releasing haunting new footage of the victims — and warning that the gut-wrenching clips were only a teaser to their “last messages.”

The hostages, looking gaunt and exhausted, identify themselves for the camera before the footage transitions to still frames — including one threatening to release the captives’ full statements in a matter of hours, according to the terrorist propaganda video posted on Telegram.

“Hours & We will release their last statements,” the video text said in Hebrew, English and Arabic.

It is not clear when the footage was taken — but the hostages are believed to have been fatally shot at close range multiple times two to three days before their bodies were found Saturday.

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The dead hostages have been identified as US-Israeli Hersh Goldberg-Polin, 23, Eden Yerushalmi, 24, Ori Danino, 25, Alex Lobanov, 32, Carmel Gat, 40, and Almog Sarusi, 27.

Autopsies indicated that the group endured nearly 11 months in captivity before they were killed.

Hamas previously released similar videos of Oct. 7 hostages — footage that the Israeli government has denounced as a form of psychological warfare.

Israeli media outlets do not carry the traumatizing video clips.

Past Hamas videos included a brief message from Goldberg-Polin. It was released in April.

In the video, Goldberg-Polin identified himself as Israeli and said he had been held captive for “nearly 200 days,” which suggested that the video was taken shortly before it was released.

The dual American-Israeli citizen was missing part of his left arm, which was blown off by a Hamas grenade when the Palestinian terror group descended on the Nova music festival in southern Negev during the Oct. 7 massacre in Israel.

Goldberg-Polin saw his friend Aner Shapira murdered by the attackers before he and a handful of other injured survivors were carted off to the Gaza Strip in the back of a pickup truck, horrifying footage of the abduction showed.

His body and those of the five other slain hostages found Saturday were released to their families over the weekend.

Relatives of Goldberg-Polin were joined by thousands of mourners at his funeral service in Jerusalem on Monday.

His mother, Rachel Goldberg, begged her murdered son for forgiveness for not being able to bring him home alive.

“If there was something we could have done to save you, and we didn’t think of it, I beg your forgiveness. We tried so very hard, so deeply and desperately. I’m sorry,” she said during the ceremony.

Goldberg and Hersh’s father, Jon Polin, traveled the world over the past 11 months rallying support for their son and the other hostages.

‘’It’s totally unacceptable that it’s six months, and we’re not yet seeing any real traction on getting our loved ones home,” Polin said at the time.

“All of us — our political leaders, across Israel, across the US, Hamas, Egypt, Qatar — we’re all failing [the hostages].”

https://nypost.com/2024/09/02/world-news/hamas-taunts-dead-hostages-families-with-videos-of-last-messages/

FDA Rejects MDMA-AT for PTSD, but Lykos, Others, Vow to Push on

The US Food and Drug Administration's (FDA) decision not to approve midomafetamine-assisted therapy (MDMA-AT) for posttraumatic stress disorder (PTSD) puts the therapy's near-term future in doubt, but officials say the rejection may not knock it out of contention as an eventual therapeutic tool for a variety of conditions.

As reported by Medscape Medical News, earlier this month the agency declined to approve the drug with currently available study data and requested that the company conduct an additional phase 3 trial. The agency's action had potentially devastating consequences for MDMA-AT's sponsor, Lykos Therapeutics, and was a huge disappointment for researchers, clinicians, and patients who were optimistic that it would be a new option for a condition that affects 13-17 million Americans.

For now, no other company is poised to imminently seek FDA approval for MDMA.

Despite the setback, research into MDMA that combines different psychotherapeutic approaches continues. Currently, there are seven US studies actively recruiting participants, and another 13 are registered with an eye toward starting recruitment, as reported on ClinicalTrials.gov.

The lack of FDA approval "actually increases the opportunity now for us to do trials," said Michael Ostacher, MD, professor of psychiatry and behavioral sciences at Stanford Medicine in Stanford, California. Researchers won't have to be sponsored by Lykos to get access to MDMA, he said.

"There's a lot of energy and interest in doing these studies," he told Medscape Medical News, adding that philanthropic organizations and the Veterans Administration (VA) are contributing funds to support such studies.

The VA provided a statement to Medscape Medical News saying that it "intends to gather rigorous scientific evidence on the potential efficacy and safety of psychedelic compounds when used in conjunction with psychotherapy." It also noted that "these studies will be conducted under stringent safety protocols and will mark the first time since the 1960's that VA is funding research on such compounds."

Rachel Yehuda, PhD, director of the Center for Psychedelic Therapy Research at Icahn School of Medicine at Mount Sinai in New York City, told Medscape Medical News that the FDA rejection "raises questions about how to keep the work going."

Without the FDA's imprimatur, MDMA remains a schedule 1 drug, which means it has no valid medical use.

"It's a lot more complicated and expensive to work with a scheduled compound than to work with a compound that has been approved," Yehuda said.

Also, without Lykos or another drug company sponsor, investigators have to find an acceptable MDMA source on their own, said Yehuda, who was an investigator on a study in which Lykos provided MDMA and funding but was not involved in study design, data collection, analysis, or manuscript preparation.

Lykos in Disarray

Within a week of the FDA's decision, Lykos announced it was cutting its staff by 75% and that Rick Doblin, PhD, the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS) that gave rise to Lykos, had resigned from the Lykos board.

A frequently controversial figure, Doblin has been attempting to legitimize MDMA as a therapy since the mid-1980s. He formed a public benefit corporation (PBC) in 2014 with an eye toward FDA approval. The PBC fully separated from MAPS in 2024 and became Lykos.

Although the FDA has left the door open to approval, Lykos has not released the agency's complete response letter, so it's not clear exactly what the FDA is seeking. In a statement, the company said it believes the issues "can be addressed with existing data, post-approval requirements, or through reference to the scientific literature."

Lykos told Medscape Medical News in an email that it is working on "securing the meeting with the FDA" and that it "will work with the agency to determine what needs to be done to fulfill their requests."

Soon after the FDA decision, Lykos was hit with another blow. The journal Psychopharmacology retracted an article that pooled six Lykos phase 2 studies, claiming the paper's authors knew about unethical conduct before submission but did not inform the publisher.

Lykos said the issues could have been addressed through a correction and that it has filed a complaint with the Committee on Publication Ethics. It also noted that the misconduct at issue was reported to the FDA and Health Canada.

"However, we did not disclose the violations to the journal itself, an additional step we should have taken and regret not doing," the company said. It added that the efficacy data in the paper were not part of the FDA submission.

Author Allison A. Feduccia, PhD, cofounder of Psychedelic Support, agreed with the retraction but disagreed with the wording. In a post on LinkedIn, she said she and other authors were not informed about the misconduct until years after the study's submission.

Four authors — including Doblin — disagreed with the retraction.

Doblin said in a statement that he'd resigned from Lykos to escape the restrictions that came with being a fiduciary. "Now I can advocate and speak freely," he said, adding that he could also return to his activist roots.

He predicted that Lykos would eventually gain FDA approval. But if Lykos can't convince the agency, it have the necessary data already in hand; "potential FDA approval is now at least 2 years away, possibly more," Doblin said in his statement.

Research Continues

Lykos is not the only company hoping to commercialize MDMA. Toronto-based Awakn Life Sciences Corp. has an MDMA preclinical development program for addiction. In addition, some companies are offering MDMA therapy through clinics, such as Numinus, in Utah, and Sunstone Therapies, in Rockville, Maryland.

But Lykos was the closest to bringing a product to market. The company is still a sponsor of four MDMA-related clinical trials, three of which appear to be on hold. One study at the VA San Diego Healthcare System, San Diego, that is actively recruiting is an open-label trial to assess MDMA-AT in combination with brief Cognitive-Behavioral Conjoint Therapy for PTSD.

Those studies are among 13 US trials listed in ClinicalTrials.gov that have not yet begun recruiting and seven that are actively recruiting.

Among them is a study of MDMA plus exposure therapy, funded by and conducted at Emory University in Atlanta. One of the Emory principal investigators, Barbara Rothbaum, MD, has also been named to a Lykos' panel that would help ensure oversight of MDMA-AT post-FDA approval.

Ostacher is an investigator in a study planned at VA Palo Alto Health Care System, Palo Alto, California, that will compare MDMA-AT with cognitive processing therapy in veterans with severe PTSD. He said it will be open-label in an effort to minimize expectation bias and issues with blinding — both problems that tripped up the Lykos application. Although placebo-controlled trials are the gold standard, it's not ideal when "the purpose of the drug is for it to change how you see the world and yourself," Ostacher said.

The study aims to see whether MDMA-AT is better than "a much shorter, less onerous, but quite evidence-based psychotherapy for PTSD," he said.

The FDA's decision is not the end of the road, said Ostacher. "Even though I think this makes for an obvious delay, I don't think that it's a permanent one," he said.

Yehuda also said she is not ready to give up.

"We don't plan on stopping — we plan on finding a way," she said.

"In our experience, this is a very powerful approach that helps a lot of people that haven't found help using other approaches, and when it's in the hands of really trusted, experienced, ethical clinicians in a trusted environment, this could be a real game changer for people who have not been able to find belief by traditional methods," she said.

Ostacher reported no relevant financial relationships. Yahuda is the principal investigator on clinical trials for the Center for Psychedelic Psychotherapy and Trauma Research that are sponsored by the Multidisciplinary Association for Psychedelic Studies and COMPASS Pathways.

https://www.medscape.com/viewarticle/fda-rejects-mdma-ptsd-lykos-others-vow-push-2024a1000fvl

David Stockman On The Mother Of All Housing Bubbles

by David Stockman via InternationalMan.com,

America’s bubblicious economy will soon hit another milestone of sorts—-the $50 trillion mark with respect to the market value of owner-occupied residential real estate. At the present moment, this figure (purple line) stands at $46 trillion (Q1 2024), which is nearly 2X its pre-crisis level of $24 trillion in Q4 2006. It’s also 8X its level when Greenspan took the helm at the Fed ($5.6 trillion) after Q2 1987 and a staggering 51X the $900 billion value of all owner-occupied homes when Tricky Dick did the dirty deed at Camp David in August 1971.

Needless to say, neither household incomes nor the overall US economy have grown at anything near those magnitudes. For instance, nominal GDP is up by 24X or less than half the gain in housing values since Q2 1971. As a consequence, the value of owner-occupied housing relative to GDP has climbed steadily higher over the last 50 years:

Market-Value of Owner-Occupied Housing As % of GDP Since 1971:

Q2 1971: 79%.
Q2 1987: 117%.
Q4 2006: 172%.
Q1 2024: 175%.

Market Value of Owner-Occupied Real Estate And % Of GDP, 1970 to 2024

Here’s the thing. The US economy was downright healthy in 1971. During the 18 years between 1953 and 1971 real median family income rose from $38,400 to $62,700 or by a robust 2.8% per annum. So the fact that residential housing represented only 79% of GDP at that point was not indicative of some grave deficiency or structural malfunction in the US economy.

Indeed, when you note that real median family income rose by only 0.8% per annum during the most recent 18 year period, or by just 29% of the 1953-1971 rate, you might well conclude that it would have been wise to leave well enough alone. Not only was the main street economy prospering mightily, but it was being accomplished with honest interest rates owing to Fed policy that was constrained by the Breton Woods gold exchange standard and also by the sound money philosophy that prevailed in the Eccles Building during the William McChesney Martin era.

As shown below, the 10-year UST benchmark rate during that period exceeded the CPI inflation rate by more than 200 basis points most of the time, save for brief periods of recession. Yet the US economy thrived, real living standards rose steadily and the residential housing market literally boomed.

Inflation-Adjusted Yield On 10-Year UST, 1953 to 1971

The subsequent period between 1971 and 1987, of course, was racked first by the double digit inflation of the 1970s and then the brutally high nominal interest rates that issued from the Volcker Cure during the first half of the 1980s. But by 1986 consumer inflation was back to just below 2% and heading lower, thereby paving the way for interest rates to normalize to a low inflation economy.

But the new Fed chairman, Alan Greenspan, had other ideas. Namely, the notion that “disinflation” as opposed to no inflation was good enough for government work; and also that the Fed could actually improve upon the jobs and income performance of the main street economy via what he labeled the “wealth effects” doctrine. That is, if the Fed kept Wall Street percolating happily and the stock indices rising robustly, the increased wealth among households would kindle capitalist animal spirits, thereby fueling enhanced spending, investment, growth, jobs and incomes.

Notwithstanding Greenspan’s mumbling and opaque messaging, what he was doing actually amounted to monetary humbug as old as the hills. He launched an era in which real interest rates were pushed steadily and artificially lower to the zero bound and below on the theory that rates well below what would otherwise prevail under honest supply and demand conditions on the free market would elicit an enhanced level of economic growth and prosperity.

It never happened on a sustained basis, of course, because below market interest rates only cause an accumulation of above normal debt levels in the public and private sectors alike—along with widespread economic distortions and malinvestment on main street, unsustainable leveraged speculation on Wall Street and, at best, the swapping of more economic activity today for reduced activity and higher debt service tomorrow.

In any event, the inflation-adjusted benchmark US Treasury rate marched virtually downhill for the next three decades, ending deep in negative territory by the early 2020s. The ill-effects were widespread throughout the economy and in this instance turbo-charged by the deep tax preferences for home mortgages. So the inflow of cheap debt into the residential housing market was massive and sustained.

There is no mystery as to why: Economic law says that when you subsidize something heavily, you get more of it. And the implicit Fed subsidies depicted in the graph below were heavy indeed.

Inflation-Adjusted Yield On the 10-Year UST, 1987 to 2024

Needless to say, economic law had its way with the residential mortgage market. Big time. Household mortgage debt (black line) had stood at $325 billion or just 50% of household wage and salary income (purple line) back in 1971. But by the peak of the subprime borrowing spree in 2008-2009, mortgage debt had risen by 33X to nearly $11 trillion.

Consequently, the mortgage debt burden soared to 170% of household wage and salary income before abating modestly during the period since 2009. But the point is, the Fed’s severe interest rate repression during that period caused a financial arms race in the residential housing market—with ever more debt pushing housing prices ever higher.

In short, it wasn’t the free market or even steadily rising, albeit more slowly growing, GDP that caused residential housing values to go from 79% of GDP in 1971 to 175% of GDP at present. Instead, it was a sustained, fiat credit fueled tidal wave of housing price inflation—a financial torrent that bestowed large windfalls on earlier period buyers (i.e. Baby Boomers) while progressively squeezing later comers and income and credit-challenged households out of the so-called American Dream of home ownership.

Indeed, the housing inflation tsunami was by no means an equal opportunity benefactor. One study based on the Fed’s periodic survey of consumer finances, in fact, showed that between 2010 and 2020 upper income households, defined as those having an average income of $180,000, saw their collective housing investments rise from $4.5 trillion to $10.3 trillion. That was a 130% gain in just one decade!

By contrast, the housing investment value held by lower income households, defined as having an average income of $29,000, rose from $4.46 trillion to, well, $4.79 trillion. That’s a piddling gain of just 3.5%, which amounted to a double digit lost when you account for the 19% plus rise in the CPI during the same 10-year period.

Household Mortgage Debt and Mortgage % of Wage and Salary Income, 1971 to 2009

To be sure, the Fed heads were not explicitly trying to redistribute wealth to the top of the economic ladder, although that’s most surely what happened. Instead, the whole theory of interest rate repression was that it would stoke a higher level of spending and investment than would otherwise occur, and especially so in the residential housing sector.

Needless to say, no cigar on that front. Residential housing completions per capita and residential housing investment as a % of GDP have been heading relentlessly southward every since Nixon rug-pulled the dollar’s anchor to gold and unleashed the Federal Reserve to foist monetary central planning on the main street economy.

As depicted by the black line, for instance, residential housing investment as a percent of GDP dropped from 5.7% in 1972 to just 3.9% in 2023. The only deviation from this steady downward trend was in 2003-2006, which is to say the very interval during which Bernanke’s first experiment with 1% money fueled the subprime mortgage and house price inflation disaster.

In fact, the chart below paired with the first one above with respect to nearly $50 trillion value of homeowner occupied real estate tells you all you need to know about the folly of Keynesian central banking. To wit, artificially cheap money does not stimulate higher levels of real output and income over time; it merely causes existing assets to be bid-up and inflated in the secondary markets.

Per Capita Private Housing Units Completed and Residential Investment % of GDP, 1972 to 2023

In turn, the systematic and relentless inflation of existing assets confers windfall gains and losses on the public in an entirely capricious manner but with the perverse effect of redistributing wealth to the top of the economic ladder. The Fed’s entire financial repression model is therefore not only pointless and ineffective—it’s profoundly iniquitous, too.

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https://www.zerohedge.com/markets/david-stockman-mother-all-housing-bubbles