Appeals court blocks Biden student debt plan as Supreme Court battle brews

 A federal appeals court on Friday blocked President Biden’s new student debt relief plan, teeing up a potential expansion of the legal fight already brewing at the Supreme Court. 

The 8th U.S. Circuit Court of Appeals ruling extends the brief pause it ordered last month. The court’s updated decision prevents the administration from moving ahead with its Saving on a Valuable Education (SAVE) plan until the court resolves the lawsuit, which could take months. 

The 3-0 ruling called the plan a “vast assertion of newfound power” and said the Biden administration fell far short of showing clear authorization from Congress.  

“The new SAVE plan … is an order of magnitude broader than anything that has come before,” the court wrote in its unsigned, 10-page opinion. 

The panel, all appointed by Republican presidents, also rejected the administration’s attempted workaround after a district judge invalidated portions of the plan at a previous stage of the case. 

Seven Republican state attorneys general sued over the SAVE plan, which was introduced last year after the Supreme Court struck down the president’s universal student debt relief program. 

The new income-driven repayment plan had two phases. The first phase occurred last fall, raising the income protected from payments from 150 percent above the federal poverty guidelines to 225 percent and waiving accrued unpaid interest outside the calculated payments. 

The second part was set to occur in July, when undergraduate student loan repayments were to be dropped from 10 percent of discretionary income to 5 percent and other loan forgiveness options became available to certain groups.

The new ruling adds to the state of confusion borrowers have been in due to the various rulings about the SAVE plan, with potential déjà vu heading their way as the Supreme Court is asked to get involved.  

In a separate challenge, three Republican state attorneys general have filed an emergency request urging the high court to temporarily block the second half of the plan — and agree to take up the challenge on the merits during the court’s next term. 

Friday’s ruling could lead the Justice Department to file an emergency appeal at the Supreme Court, too, or similarly urge the court to hear the case in full, now. 

https://thehill.com/homenews/education/4821278-biden-student-loan-relief-debt-forgiveness-save-plan-supreme-court/

Cartel Drones Fly With Explosives Near Southern Border

 Vice President Kamala Harris' role as President Biden's "border czar" has sparked the worst border crisis in American history, a fact well known by now. However, a new report highlights a concerning new threat stream: drug cartels on the southern border are increasingly weaponizing drones with explosives, similar to what's being seen on modern battlefields in Eastern Europe and the Middle East. All of this is happening under VP Harris' watch. 

Here's the report from the New York Post: 

Cartel drones packed with explosives are flying just south of Arizona's border with Mexico, The Post has learned, alarming Senate defense hawks who are pushing for legislation to counter novel aerial incursions into the US.

Members of Los Salazar, a cell of the notorious Sinaloa Cartel in Mexico, are using drones "to drop explosives" on Los Pelones, an independent rival cartel, as part of ongoing conflict in Sonoyta, Mexico, according to an internal bulletin circulated by the US Border Patrol's Yuma Sector Intelligence Unit on Tuesday.

The US Border Patrol's internal bulletin noted the following:

The Yuma Sector Intelligence Unit recently received information that members of Los Salazar are utilizing drones to drop explosives on members of Los Pelones in an ongoing confrontation south of Sonoyta, MX. Other confrontations between these two organizations have occurred along the border, south of Wellton Stations area of operations, in recent months.

Souce: NYPost

Separately, US Northern Command's top general, Air Force Gen. Gregory M. Guillot, told the Senate Armed Services Committee in a hearing in mid-March that more than 1,000 incursions of drones occur along the southern border each month.

Guillot warned lawmakers on Capitol Hill that the incursions present a "growing" defense threat to the homeland. 

Since the Biden-Harris Administration assumed office, there have been more than 8 million illegal aliens encountered entering the country through the southwest border and over 1.6 million 'gotaways.' 

Biden-Harris' border crisis is an absolute mess, which has contributed to murders, sexual assaults, and serious bodily injuries committed against numerous Americans by illegal aliens. 

Earlier this week, an interim staff report from the House Judiciary Committee and Subcommittee on Immigration Integrity, Security, and Enforcement, revealed nearly 100 illegal aliens on the FBI terror watchlist were released into the US after being arrested by Border Patrol. 

Most Americans care about two things before the elections: 1) inflation and 2) the border. 

For Harris and Obama's Democrat party, there's no escaping that disastrous border issue.

https://www.zerohedge.com/political/biden-harris-mess-cartel-drones-fly-explosives-near-southern-border

Not Your Father’s DNC

 Being academics or ex-academics, we have quite a few friends who were there in Chicago in 1968, protesting the war in Vietnam in front of the Democratic National Convention. We’ve heard stories of Jerry Rubin, the famed Yippie mischief-maker, attempting to nominate a pig (“Pigasus”) as president, and of the Beat poet Allen Ginsberg leading a mass march amid chants of “peace now.” Though we don’t share our friends’ political convictions, we are enamored of such stories of youthful activism and conviction—of dedicated men and women taking risks to rescue their country from what they believed was a disastrous course of action.

Don’t expect these inspiring scenes to repeat later this month, when the 2024 DNC reconvenes in Chicago. This time, the protesters huddled outside are not going to be Clean for Gene—the catchy slogan coined by antiwar candidate Eugene McCarthy’s supporters—but rather tainted by affiliations with terror groups. To understand why, consider events of last month in Washington, D.C.

When Israeli prime minister Benjamin Netanyahu arrived in town to deliver a special speech to both houses of Congress, a throng of activists sprung to action. First, they promised to conduct a “citizen’s arrest” of the Israeli leader; security, thankfully, foiled their attempts, but about 200 of the protesters were nevertheless arrested in Cannon Rotunda. Outside Union Station, rioters defaced a replica of the Liberty Bell with the slogan “F--- Israel,” and ominously sprayed “Hamas is Coming” on a nearby monument to Christopher Columbus, before wreaking havoc on the train station itself. And if any of these actions were too subtle, a few raised the Palestinian flag on a nearby flagpole, while burning an effigy with the American flag wrapped around it. Inside the Watergate Hotel, which housed Netanyahu and his delegation, protesters released a swarm of maggots and other insects and constantly set off the fire alarms, “to ensure,” they said, “that there will be no rest” for Netanyahu before his address.

It’s a far cry from the playful antics of Pigasus and his pals, and it raises an urgent question: Who were these violent, motivated, and well-organized hooligans?

Asra Nomani, a Muslim American journalist who had worked with Daniel Pearl for the Wall Street Journal and writes frequently about the perils of Islamism, covered some of these protests, and observed that many of those arrested were bused into town by an organization called American Muslims for Palestine (AMP).

The group, currently under investigation by Virginia attorney general Jason Miyares for allegedly funneling funds to Hamas, is no stranger to controversy. It was founded in 2005, and, according to one recent lawsuit, employs more than half a dozen former associates of now-defunct organizations—including the Holy Land Foundation for Relief and Development and the Islamic Association for Palestine (IAP)—that had been disbanded after members were convicted for materially supporting Hamas.

The lawsuit against AMP was brought by Stanley and Joyce Boim, whose 17-year-old son, David, was murdered by Hamas outside Jerusalem in 1996. Seeking justice, the Boims sued a host of American nonprofits that they argued were merely fronts for Hamas and were awarded $156 million in damages in 2004. Rather than pay up, however, the groups in question closed down. A trove of documents based on evidence from the case, presented last year before the House Ways and Means Committee, shows the extraordinary overlap between said groups and AMP. For example, Rafeeq Jaber, the IAP’s former president, prepared the tax documents needed to launch AMP, while IAP’s former secretary general, Abdelbaset Hamayel, appeared on these documents as the person “who possesses the organization’s books and records.” AMP’s founder, Hatem Bazian, also collaborated with IAP and was a popular speaker at their events. In 2017, the Boims filed a new lawsuit claiming, in the presiding judge’s words, that “these new defendants are alter egos of the now-defunct nonprofit organizations and therefore liable for the remainder of the $156 million judgement.”

Bazian is also the founder of Students for Justice in Palestine, a group suspended by several universities for its members’ anti-Israeli and anti-Jewish activities.

Another outfit, National Students for Justice in Palestine, is being sued by victims of Hamas’s deadly October 7 attack for serving “as collaborators and propagandists” for the terror group. NSJP is sponsored by an organization called the Westchester Peace Action Committee Foundation (WESPAC), which also sponsors a group called the Palestinian Youth Movement, whose members are behind several of last month’s violent protests in D.C.

We understand that following a thicket of tax shelters and straw groups isn’t the average person’s idea of fun. But the torrent of anti-Semitic incidents—and the stunning similarities between them—suggests that we’re looking at an orchestrated campaign designed to terrorize Americans, paid for and organized by groups repeatedly shown to be, at the very least, Hamas-adjacent. We saw, for example, coordinated demonstrations nationwide on July 4—in New York, Los Angeles, Chicago, Philadelphia, and elsewhere—each of which featured the same ritualistic burning of the Stars and Stripes that we saw in D.C. Add to that the July statement of Avril Haines, President Biden’s Director of National Intelligence, that the Iranian government—a chief Hamas supporter—is also funding and participating in at least some of these protests, and we’re looking at what, increasingly, seems less like another chapter in the rocky but revered history of American dissent and more like a major threat to national security. Soon, that threat will be unleashed on Chicago and the DNC.

Pro-Palestinian activists are already promising that the Windy City will be flooded with “tens of thousands” of protesters urging the Democratic nominee, Vice President Kamala Harris, to sanction the Jewish state. The march’s lead organizer, Hatem Abudayyeh—who refers to President Biden as “Genocide Joe” and to Harris as “Killer Kamala”—is similarly tied to questionable groups and individuals. In 2018, he was the keynote speaker at the SJP’s national conference at UCLA. He was also reportedly a prominent defender of Rasmea Odeh, a Popular Front for the Liberation of Palestine terrorist convicted by Israeli courts for killing two civilians in a 1969 Jerusalem supermarket bombing and later deported from the United States after being convicted of immigration fraud for failing to disclose her arrest and conviction. In 2009, Abudayyeh wrote an article applauding Hamas—designated as a terror group by the State Department in 1997—and other terrorist organizations for defeating what he described as an effort to “impose an acceptance of Israeli apartheid and occupation on the Palestinian people.” In a 2009 interview, he described Hamas as a “resistance organization” and said that “the real terrorists are the governments and military forces of the U.S. and Israel.”

It’s crucial that we keep all that in mind as we watch the scenes unfold in Chicago. It’s also crucial that we reflect on how different this convention is from its famed 1968 ancestor. Back then, most of the demonstrators were passionate about changing America for the better, which is why so many observers were moved by their cause. Now, the protesters are passionate about burning America to the ground, as they’ve made clear by violently denigrating its symbols and enthusiastically supporting a terror group that still holds eight Americans hostage in Gaza. Here’s hoping that most Americans, Democrat and Republican, reject these bigots and their wicked ideology.

Liel Leibovitz is editor at large for Tablet and a senior fellow at the Hudson Institute. Asaf Romirowsky is the executive director of Scholars for Peace in the Middle East  and the Association for the Study of the Middle East and Africa. 

https://www.city-journal.org/article/not-your-fathers-dnc

Walz’s ‘weird’ slur just shows how much of a wacko he is among the rest of the left

 Tim Walz wheeled out his “weird” slur against Republicans again this week when he was introduced to the nation as Kamala Harris’ VP candidate. 

He’s proud of the fact that his quip on MSNBC’s “Morning Joe” went viral a couple of weeks ago and helped earn him running-mate status. 

“These guys are creepy and, yes, just weird as hell,” Walz said of Donald Trump and JD Vance during his debut speech in Pennsylvania Tuesday. 

Talk about the pot calling the kettle black. 

Let’s see how weird the Democrats’ new leadership is: 

It’s weird that Walz mandated tampons in boys’ bathrooms in Minnesota schools. 

It’s weird for the party that promotes itself as the guardian of democracy to install its leaders without an election. 

It’s weird that Walz dawdled for three days while Minneapolis burned before calling in the National Guard during 2020’s BLM-antifa riots.

He abandoned the city’s Third Precinct police headquarters when it was overrun and set ablaze.

Walz explained his weird lack of action as a desire not to be “oppressive” to the rioters who had suffered “generations of pain” and “fundamental, institutional racism.” 

It’s weird that Walz’s wife kept the windows open “as long as I could” during the riots so she could “smell the burning tires” and savor the historic moment. 

It’s weird that Walz let his then-19-year-old daughter leak the National Guard’s deployment plans on Twitter so rioters knew they could keep destroying Minneapolis. 

It’s weird that Harris and Walz base their campaign on “freedom” yet he was the most authoritarian governor in the country during the pandemic, ruling by decree for 15 months, enforcing draconian shutdown orders, mask mandates and curfews. 

It’s weird that Walz tells Republicans to “mind your own damn business” when he created a COVID telephone “snitch line” so that people could inform on their neighbors who breached his draconian COVID restrictions. 

It’s weird that Walz defended censorship of COVID dissenters by telling MSNBC: “There’s no guarantee to free speech on misinformation or hate speech especially around our democracy.” 

It’s weird that Walz signed laws allowing teenagers to be sterilized and genitally mutilated without parental consent and called it “gender-affirming care.” 

It’s weird that Walz signed into law a new definition of “sexual orientation” that deleted an exemption against pedophilia. 

It’s weird that Walz has turned Minnesota into a “trans refuge” with a law that removes children from parents who don’t agree to their kids’ sex-change surgery and hormone treatment.

Even transgender Minnesota state Rep. Leigh Finke called the bill “beautifully weird.” 

It’s weird that Walz has turned Minnesota into an “abortion mecca” with no time limit up to the moment of birth and sometimes beyond, and no requirement that minors inform their parents. 

It’s weird that Walz is presented as the epitome of decency and “Minnesota nice” and yet the first time he spoke to the nation, he peddled a smutty sex joke about Vance and a couch cushion made up by the bottom feeders of internet trolling. 

It’s weird that Walz has visited China about 30 times, including spending his honeymoon there.

“No matter how long I live, I’ll never be treated that well again,” he said after his first visit in 1990.

“They gave me more gifts than I could bring home.” He should compare notes with the Bidens. 

It’s weird that Walz and his wife, Gwen, chose June 4 as their wedding date to commemorate the bloody anniversary of China’s brutal crackdown on democracy protesters in China’s Tiananmen Square.

“He wanted to have a date he’ll always remember,” said Gwen. 

It’s weird that Walz quit the National Guard when he was about to be deployed to Iraq, then told everyone he had gone to war. 

It’s weird that Walz said he wanted to provide ladders to illegal migrants so they could climb over Trump’s border wall. 

It’s weird that Waltz says, “One person’s socialism is another person’s neighborliness.” 

It’s weird that Harris and Walz claim they are defending “democracy” but he signed a law to give driver’s licenses to illegal aliens, the first step to voting ­illegally in elections. 

It’s weird that Walz criticizes Trump for his record on law and order when crime in Minneapolis has soared on his watch. 

It’s weird that he poses as a “folksy,” common-sense working man with “Midwestern dad vibes” who hunts and wears camo caps.

Yet he governs like a crazed, green-haired radical, with taxes among the highest in the country and residents fleeing the state as fast as they can. 

It’s weird that Walz is a teacher married to a teacher, the son of a teacher and claims education is a priority, yet on his watch, Minnesota students’ average reading and math scores have plummeted to below the national average, according to the National Assessment of Educational Progress. 

Despite record spending, for the first time majorities of K-12 students are not meeting grade-level standards, finds the Minnesota Center of the American Experiment.

Minnesota’s CNBC education ranking has dropped from fifth to 19th place in the country since he became ­governor. 

It’s weird that Harris has not done a single interview since being appointed the presumptive Democratic nominee for president more than two weeks ago. 

It’s weird that she laughs at her own jokes. 

In psychology, attributing your own flaws to others is called projection, and Walz and Harris have a bad case of weird.

New Hunter bombshells

One of the reasons Democratic kingmakers decided to bounce Joe Biden became evident in the latest bombshell court filings in first son Hunter’s upcoming tax trial, which refer for the first time to potential foreign lobbying violations. 

While prosecutors for special counsel David Weiss say the government “does not intend to reference allegations that the defendant violated FARA or improperly coordinated with the Obama administration,” they do say that Hunter was hired by a Romanian oligarch in an “attempt to influence US government agencies.” 

Further, they say the roughly $1 million that Hunter was paid by Romanian oligarch Gabriel Popoviciu during his father’s vice presidency was structured in a way that “concealed the true nature of the work he was performing” and to make sure it didn’t “cause political ramifications” for Joe. 

The filings indicate that if the trial goes ahead next month in California without Hunter taking a plea, it will implicate his father in the family influence-peddling business. 

The fallout from Hunter’s lucrative deals in Romania, Ukraine, China and beyond would have damaged his father’s re-election prospects if he were still the candidate. 

Regardless of what the president has said, there is no doubt he will pardon his son before he leaves office.

https://nypost.com/2024/08/07/opinion/tim-walzs-weird-slur-just-shows-how-much-of-a-wacko-he-is-among-the-rest-of-the-left/

KUDLOW: Worried about recession? Cut taxes, not interest rates

 At his press conference yesterday, former President Trump made it absolutely 100% clear that he was the candidate of tax cuts and Kamala Harris is the candidate of tax increases. 

Maybe she thinks she's the new Walter Mondale, who campaigned on tax hikes and lost 49 states. After all, her running mate is a far-left progressive from Minnesota, just like Mondale.  

In view of the shaky stock market, rising unemployment and a softening economy, Mr. Trump's tax cut pledge — and his fight against Ms. Harris' tax hike plan — is going to become a super important issue in the last three months of the campaign.

FORMER PRESIDENT TRUMP: But they always say, we're going to give you a tax increase, but in all the years of studying politics, I've never seen people get elected by saying, we're going to give you a tax increase. | And I'm going to work it out that there's no tax on Social Security for seniors. I'm also doing no tax on tips.

There you have it. That sends a very strong message to voters, especially middle-class voters, who are increasingly worried about unemployment. For example, columnist Salena Zito writing in the New York Sun reminds us that middle America, after struggling with high prices, is now faced with rising unemployment.  

In fact, while overall unemployment has gone up from 3.4% to 4.3%, unemployment for those without college education has recently hit 4.6%. It's a double whammy: high prices and job losses.  

These are typical working folks, hard hats, oil and gas workers, people that toil every day with their hands. It's an unknown species for Wall Street and Silicon Valley, but it's the backbone of America, and Trump is talking directly to them when he says, "I'm going to cut your taxes and fatten your paychecks." 

TRUMP: Our tax cuts, which are the biggest in history, our tax cuts are coming due, as you know, very soon. If they don't renew them, it's the equivalent of having a four-times tax increase from what you have right now, and it'll destroy the economy.

Remember, typical families have taken a roughly 4% pay cut during the Biden-Harris years. In fact, in order to hammer home the Kamala-nomics tax hike threat, MAGA PAC is publishing a "Kamala Tax Calculator." 

Here's one example: A married person filing jointly, under 65, making $75,000 with two children, would lose $2,828 every year under a Kamala-nomics tax hike. That's real money. Now, as far as the softening economy, which may well be on the front-end of a recession, I believe a reduction in tax rates would be much more beneficial to the economy than emergency Fed rate cuts.  

If the Fed starts slamming down interest rates and pumping up the money supply, we're going to get another bout of inflation. The last thing we need is more Fed pump priming. Already the world is over-leveraged and over-borrowed.  

The Japanese yen "carry trade" has smashed stock markets. At home, the Magnificent 7 tech stocks are over-leveraged.  

The consumer has also taken on way too much debt, while payment delinquencies are rising. The economy doesn't lack for money and debt, it lacks for free enterprise incentives, but suppose Washington is truly worried about recession, then how about an emergency reduction in business and personal tax rates that would boost economic incentives, to generate more work effort and produce more goods, which would increase growth while curbing prices?  

Then layer on to that some "drill, baby, drill" to produce more oil and gas at lower energy prices. More growth, lower inflation.  

This is basically what Mr. Trump is talking about. Tax cuts spur growth and opportunity. Tax hikes bury us into recession. This is why Mr. Trump's tax cut message is so totally on target. 

https://www.foxbusiness.com/media/larry-kudlow-worried-about-recession-cut-taxes-not-interest-rates

Harris's Big Gift To Trump... If He Uses It

 by Victor Davis Hanson via X,

Harris’s selection of Walz at least reveals the left’s full-bore agenda, something that previously her handlers seemed at pains to hide: an overt doubling down on the Biden neo-socialist record that will require a far more vigorous stealth 90-day campaign to camouflage the hard-left record of both Harris and Walz.

Minnesota under Walz became merely a smaller version of Gavin Newsom’s California - shameless woke pandering, wars against fossil fuels, fiscal nihilism, thousands fleeing the state, high crime, high taxes, poor services, sanctuary city/pro-illegal alien activism, eroding downtowns of once majestic cities, loud-in-your-face, attack-dog denials of reality, a two-tier state legal system, tolerance of BLM/Antifa/Hamas street violence, and on and on.

So Walz is a force multiplier of Harris’s vulnerabilities.

His selection (was Harris terrified of leftwing threats from her base that a Shapiro pick would guarantee her 1968-like riots at her Chicago convention?) did not just reveal the now overt anti-Semitic, anti-Israel nature of the Democratic Party (Shapiro would have likely ensured Pennsylvania’s electoral votes). Her pick also reveals the confidence that the Left has in winning what will be the most flagrant, bait-and-switch 90-day campaign in presidential history.

So, the real Harris-Walz campaign messaging will be: 'In 2024 we have to lie and mislead you about who we are and what we did, so that in 2025 we can govern you in ways you will not like.’

What are the challenges for this weirdest of tickets?

Harris, in Biden-fashion, cannot finish a coherent thought. So again, like Biden in 2020, she will retreat and outsource her campaign to the media, while counting on outspending Trump 3-1, and radiating feigned moderation.

She is taking heat for neither yet meeting with a real journalist nor speaking impromptu. But in her defense, to do either might at any opportune moment collapse her stealth campaign, given that to listen to her for 60 seconds off script is to prefer her to remain silent and hidden. And she has confidence in absentia that a bankrupt media will praise her nonexistent elegance, fluency, and articulateness.

Walz will customarily serve as a designated hit man for Harris. But he is just as much a liability— a shoot-from-the-hip blowhard, while owning an even more embarrassing leftwing record than Harris. And he is even less discreet.

This week Walz introduced himself to the nation as a VP candidate by smearing J.D. Vance with the brazen “couch” lie. And then while foolishly beaming, he doubled-down on his crude slur (“See what I did there?”). So, he even outdid Harris who had recently called Trump a “predator”—just days before it was disclosed that her married husband earlier had once impregnated his own children’s young nanny and tutor and had never disclosed what followed from his predation.

Both will either ignore or lie about their joint opposition to fracking and pipelines; their disgraceful pro-BLM/Antifa advocacy during the lethal and destructive 2020 looting and rioting; their support for open borders and illegal immigration; their woke pandering; and their generic leftwing promotion of the usual high taxes, big government, poor services, and ‘who cares if they flee my state’ arrogance.

The Harris-Walz ticket will also collapse if, horribile dictu, the prior Biden-Harris appeasement of Iran, distancing from Israel, weakening of the military, and loss of deterrence in the next 90 days leads to theater-wide wars on the Ukrainian borderlands or in the Middle East and/or to a recession due to cumulative inflation, high interest, stagnant wages and anemic citizen employment, and unsustainable national debt service.

In sum, Trump is very much even in the race. He was given a rare gift by the shunning of Josh Shapiro as Harris’s running mate. That leftwing blunder could energize the Trump campaign—if again he sticks to warning the country of who these two are, what they have done, how they are hiding their real agendas, what they will do if elected, and how they differ from his own presidential record and future agenda.

Nothing else matters.

And that means Trump should ignore the now inert and evaporating Biden, refrain from attacking any Republican, stop all recriminations about 2020, avoid race and DEI ambushes, and prep hard and in detail for as many debates as he can obtain.

Trump should appear magnanimous and above the fray by compromising with Harris on the debates: one debate now by her rules on ABC, and one by his rules on Fox before early voting begins.

Rarely have the Democrats so foolishly gone hard left.

And when they did in 1972, 1980, and 1988, Republicans used to know how to use those gifts, expose them, and win landslides despite media and institutional bias.

They can do it again, but only if they are as adroit, united, and disciplined as their predecessors once were.

https://www.zerohedge.com/political/harriss-big-gift-trump-if-he-uses-it

In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

 The Food and Drug Administration has rejected a bid to get MDMA approved as a therapy aid for people with post-traumatic stress disorder, a decision that puts off a major milestone for the field of psychedelics.

The verdict Friday comes at a pivotal time for this area of research, which has, after decades of dismissal from top drug regulators and companies, recently gained momentum through the work of advocacy groups and powerful organizations like the Department of Veterans Affairs. A bipartisan group of 80 congressional members this month urged the Biden administration to approve the treatment developed by Lykos Therapeutics, a California-based biotechnology company.

Had the agency complied, MDMA would have become part of the first psychedelic-assisted therapy cleared in the U.S. It also would have created another treatment option for PTSD, which, according to VA estimates, affects around five out of every 100 adults in the country in any given year. These people are often prescribed cognitive behavioral therapy or so-called SSRI drugs to help with symptoms, but a large portion don’t respond.

According to Lykos, the FDA concluded that it couldn’t approve the therapy based on the data submitted, and requested the company run another Phase 3 trial to further study the safety and efficacy of MDMA. Lykos said it plans to ask for the agency to reconsider its decision.

“The FDA’s decision to request another Phase 3 study is a major setback for the field,” said Jennifer Mitchell, a professor of neurology, psychiatry and behavioral sciences at the University of California, San Francisco, in Lykos’ statement.

The pharmaceutical industry has long been intrigued by the mind-altering effects of MDMA — also known as midomafetamine or the party drug ecstasy — and whether they may be useful in treating various mental health conditions. The thinking goes that MDMA makes patients more emotionally open and able to connect with their therapist during psychotherapy sessions, which research suggests leads to better outcomes.

For years, Lykos, formerly known as MAPS Public Benefit Corp., has tried to test that hypothesis through a series of clinical trials focused on PTSD. The two largest indicated that participants given MDMA along with psychotherapy experienced significant reductions in the severity of their symptoms.

“I don’t know of any other psychoactive substance that affects your experience of another person in quite the same way. It’s remarkable,” said Anya Bershad, an assistant professor of psychiatry at the University of California, Los Angeles, whose research focuses on how MDMA alters social behavior.

“Psychotherapy is a great tool across diagnoses, and if we can find a way to make it a little bit more effective, especially for patients where other treatments aren’t working as well,” that would be “really exciting,” Bershad added.

Since positive results are exceedingly rare in mental health drug trials, Lykos was confident its findings would be enough to secure approval.

FDA staff weren’t so convinced, however. In early June, the regulator convened a panel of experts in psychiatry, medicine and drug development, and asked them to assess the evidence Lykos had gathered. In that meeting, agency scientists expressed doubts about the strength of Lykos’ results and criticized some of the ways the company collected and analyzed data.

One sticking point in particular was that, because MDMA elicits unmistakable changes to cognition and the senses, most of the participants in Lykos’ studies were able to decipher if they had been given the drug or a placebo. Both FDA staff and agency advisers feared that this so-called functional unblinding may have swayed the results in an overly positive direction.

That issue isn’t specific to MDMA, though, and psychedelics developers and regulators have yet to agree on how to adequately address it in clinical trials.

“Functional unblinding is a problem for everybody. So if that’s the basis of rejection, then we might as well all go home,” said Gul Dölen, a psychology professor at the University of California, Berkeley, who has conducted studies on the effects of MDMA on the brain.

At the committee meeting, FDA staff also noted alleged ethics violations in the studies, including sexual misconduct and data suppression. Many of the experts shared those concerns, leading them to vote almost unanimously against the therapy.

“I’m not convinced at all that this drug is effective based on the data I saw,” Rajesh Narendran, a psychiatry professor at the University of Pittsburgh and the committee’s chair, said at the time.

The decisively negative vote may have nudged the FDA toward a rejection, because while the agency isn’t required to follow the recommendations of its advisers, it typically does.

Experts have debated to what extent the FDA’s decision will affect the broader psychedelics field. Some don’t expect much of an impact. Analysts at the investment firm Leerink Partners, for instance, viewed many of the issues raised during the advisory committee meeting as specific to MDMA-assisted therapy.

But given that Lykos’ application is the first of its kind to go before the FDA, others see the rejection as a landmark verdict.

“This is not just a niche application,” Dölen said. “This is going to set the tone.”

Dölen said she would worry if the FDA rejected the treatment because it didn’t want or know how to regulate the therapy component of Lykos’ application. During the advisory committee meeting, there were questions about the amount psychotherapy contributed to the results, and how the psychotherapy protocol would be standardized if the FDA granted approval.

Drug companies “will sell more medicine, more patented medicine, if it doesn’t have to be combined with therapy,” Dölen said. “And in my view, the protection that we need most in this space is making sure that the requirement of therapy is in place, because otherwise, I think these drugs are not going to be efficacious and potentially going to do harm.”

In its statement, Lykos acknowledged how the combination of MDMA and therapy “raises unique research questions,” but stood by its data, arguing the evidence is “sufficient” and “in line with the relevant FDA guidance.” The company also called out the advisory committee, both for its “limited number of subject matter experts” and the “nature of [their] discussion, which at times veered beyond the scientific content” presented.

The FDA’s request for another trial is “deeply disappointing,” according to Lykos’ CEO Amy Emerson, who added that such a trial would take several years to complete. The company claims it can answer many of the FDA’s outstanding questions with existing data, Emerson said.

“No matter what, we as researchers believe that we need more research in this area,” Bershad said.

https://www.biopharmadive.com/news/fda-mdma-therapy-rejection-psychedelics-lykos/723869/