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US drug regulators reject ecstasy as mental health treatment

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US drug regulators reject ecstasy as mental health treatment

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US medicines regulators have rejected a bid to get schedule-1 drug MDMA, better known as the party drug ecstasy, approved as a treatment for post-traumatic stress disorder, marking a significant setback for the nascent psychedelics sector.

The US Food and Drug Administration issued Lykos Therapeutics, the biotech behind the treatment, with a notice known as a “complete response letter” asking the company to carry out costly fresh phase-three trials because of concerns over the way the original studies had been conducted.

Lykos said in a statement on Friday that the agency’s concerns “echo” those raised by a panel of outside experts convened by the regulator in June. The FDA advisory committee voted overwhelmingly against approving the treatment which combined MDMA with therapy, citing concerns over the way Lykos’s clinical trials had been designed.

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The FDA said “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication”.

Carrying out fresh late-stage trials is likely to cost Lykos tens of millions of dollars, forcing it to raise more money from investors or putting its decades-long efforts to get MDMA approved as a PTSD treatment in peril. Lykos is the for-profit offshoot of a psychedelic advocacy group dating back to the 1980s.

The FDA advisory committee in June pointed to struggles with ensuring that trial participants did not know they were on the drug to avoid results bias, undermining Lykos’s claim that the study had been “double-blinded”. The panel voted nine to two that the data did not prove MDMA-assisted therapy was an effective PTSD treatment, and voted 10 to one that the treatment’s benefits did not outweigh the risks.

Possible cardiovascular risks associated with MDMA, as well as concerns about the study being corrupted by psychedelic advocacy by some of the therapists, were highlighted by the FDA panel, as well as failure to collect data on long-term abuse issues caused by the drug.

“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Amy Emerson, Lykos’s chief executive.

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About 13mn Americans, or around 3.5 per cent of US adults, suffer from PTSD, according to official statistics. PTSD sufferers, many of who are military veterans, have benefited from scant new treatments in recent years.

Lykos questioned the conduct of the FDA panel “including the limited number of subject matter experts on the panel and the nature of the discussion, which at times veered beyond the scientific content in the briefing documents” in its statement released on Friday.

The company said that it planned to request a meeting with the FDA to ask it to reconsider its decision and to seek recommendations from the agency about the best way to go about resubmitting data. Lykos previously carried out two phase-three trials into the effectiveness of MDMA as a PTSD treatment.

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Two Rivals in Michigan’s Crucial Senate Contest Say They Were Both Swatted

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Two Rivals in Michigan’s Crucial Senate Contest Say They Were Both Swatted

The two leading contenders for Michigan’s open Senate seat disclosed that they had been targeted in separate “swatting” incidents in a span of less than 24 hours, just days after winning primaries in a crucial contest that could determine which party controls the chamber.

The first incident, involving Representative Elissa Slotkin, a Democrat, happened on Thursday night at her home in Oakland County, north of Detroit. The second one occurred on Friday at an address that had been listed on public records under the name of Mike Rogers, the Republican candidate and former House member, in neighboring Livingston County.

Politicians on both sides of the political aisle have increasingly been the target of swatting in recent years. The hoaxes — when false threats are deliberately made to law enforcement to draw a heavily armed response to a person’s home — have added to a climate of intimidation and the harassment of public officials.

Ms. Slotkin was not home at the time of the incident, according to a spokeswoman for her office, Lynsey Mukomel, who said in a statement that Michigan State Police troopers went to the residence after a false threat was emailed to a local official. She did not elaborate on the nature of the false threat. Michigan State Police confirmed they responded.

“Michigan State Police checked the property and confirmed no one was in danger,” Ms. Mukomel said, adding that U.S. Capitol Police would investigate the incident.

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Mr. Rogers, a former longtime House member who was endorsed by former President Donald J. Trump, experienced a similar incident around 12:30 p.m. Eastern time on Friday, said Chris Gustafson, a spokesman for his campaign.

A person reported that a man was holding a woman at gunpoint at the property in Livingston County connected with Mr. Rogers, according to Mr. Gustafson, who said that Mr. Rogers currently does not live there but that other members of his family do.

Shanon Banner, a Michigan State Police spokeswoman, said that a sergeant had responded to a report about a domestic situation at a residence in Livingston County on Friday and determined that it was false. She was not immediately able to confirm whether it was the same property.

Mr. Gustafson, in a statement, said that it was the second time that Mr. Rogers had been targeted in a swatting incident. The first was in 2013, when he was a member of Congress.

“This kind of violence cannot be tolerated, and it is our hope that those responsible will be quickly prosecuted and held accountable,” Mr. Gustafson said.

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The rivals are running for a seat that is being vacated by Senator Debbie Stabenow, Michigan’s senior senator and a Democrat, who announced last year that she would not seek a fifth term. Democrats control the Senate by a thin 51-49 seat majority.

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Elon Musk is bringing lawsuits to Texas. A judge with Tesla stock keeps hearing them

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Elon Musk is bringing lawsuits to Texas. A judge with Tesla stock keeps hearing them

U.S. Federal Judge Reed O’Connor has been a longtime active member of the Federalist Society. In 2018, he spoke on a panel at the annual Texas Chapters Conference.

The Federalist Society/Screenshot by NPR


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The Federalist Society/Screenshot by NPR

Billionaire Elon Musk seems to have found a new favorite federal judge: Reed O’Connor in Fort Worth, Texas.

Musk’s social media company X has filed two major lawsuits against groups he sees as antagonists, and O’Connor is presiding over both of them, even though none of the parties is based in Texas.

So far, O’Connor has delivered stunningly pro-Musk decisions, which have gained widespread attention.

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What has garnered less attention: O’Connor’s investment in Tesla, between “$15,001 and $50,000” of Tesla stock, according to his most recent publicly available financial disclosure filing.

That investment has fueled questions over O’Connor’s fairness as a judge, since the outcome of the suits filed by Musk’s X could impact his business empire.

“It is absolutely reasonable to question his impartiality in a case where the party and interest is a principal in a company the judge owns stock in,” said James Sample, a professor who specializes in judicial ethics at Hofstra University’s law school.

Others have questioned whether Musk’s legal team intentionally aimed to take their cases to O’Connor’s court — something known as “forum shopping” — in hopes of a sympathetic outcome.

The practice is controversial, but not illegal. Federal rules dictating where a lawsuit can be filed are broad, said Jennifer Ahearn, senior counsel for the Brennan Center’s Judiciary Program.

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“They’re taking advantage of those openings in a way that is not common,” Ahearn said. “A reason why you don’t see that more is because you often don’t find both judges willing to accept these kinds of situations and parties willing to accept the wrath of the judges for doing that.”

But this judge, according to Ahearn, appears to be the opposite: willing to take on cases in his Texas district that would not ordinarily land there.

O’Connor, a member of the influential conservative legal group the Federalist Society, was appointed by former President George W. Bush in 2007. He has developed a reputation for handing down legal victories to Republicans, notably ruling against the Affordable Care Act and striking down federal gun regulations.

Now, O’Connor has taken on two cases from another conservative, who happens to be the richest person in the world who is using O’Connor’s court to attack perceived enemies.

O’Connor did not return multiple requests for comment. Musk did not, either.

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Musk’s suit is draining Media Matters of cash

O’Connor is now in charge of two of Musk’s most high-profile legal crusades.

One of the cases, filed this week by Musk’s X, claims a consortium of advertisers that yanked ads from the platform illegally conspired against the social media site.

The repercussions of the case were almost instantaneous.

Fearing that the lawsuit would drain its finances, the World Federation of Advertisers said on Friday it would dissolve its brand safety initiative, known as the Global Alliance for Responsible Media.

Brands Unilever, Mars, CVS and Orsted are also named as defendants.

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The second lawsuit was filed in November by Musk’s X, claiming liberal watchdog group Media Matters released a deceptive report about major advertisers appearing alongside pro-Nazi posts. The suit cited contract violations and business disparagement, a legal term for derogatory statements that harm a company.

The cost of turning over vast numbers of documents in the case, a process known as discovery, has already cost the nonprofit of about 100 people millions of dollars and forced it to lay off about 14 staffers.

Lawyers for Media Matters wrote in an email to Musk’s legal team that the document production has so far been “expansive and intrusive,” comparing the effort to “harassment,” according to legal filings, which show Musk’s legal team requesting the personal bank records of rank-and-file employees.

Five months ago, lawyers for Media Matters asked O’Connor to rule on what is often the first major hurdle of a lawsuit: a motion to dismiss determining whether Musk’s suit has any merit or not.

O’Connor green-lit the discovery process, but he still has not ruled on the lawsuit’s merits.

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Allegations of “forum shopping” lodged at Musk

Like with the Media Matters case, neither X, which is listed in the suits as a Nevada corporation, nor any of the defendants are based in Texas.

But Musk’s legal team justified filing the Media Matters case in Texas by saying the nonprofit “routinely contacts” Texans asking them to subscribe to the group’s content and that, in the second case, the advertisers have a “substantial volume of business” in Texas.

Forum shopping accusations have recently come under scrutiny in the northern district of Texas, in part because the district is distinct.

In most parts of the country, lawsuits are randomly assigned to judges. But in northern Texas, judges take on suits based on which division of the district they are filed in. That can allow parties to almost cherry-pick a judge, according to Ahearn with the Brennan Center for Justice.

“It’s particularly extreme,” Ahearn said of forum shopping in northern Texas. “It has become a problem for the judiciary in a way that it hasn’t been in the past.”

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Something else that makes the cases in Texas unique is that laws that protect people and groups from meritless lawsuits do not apply in Texas’ federal courts, under a 2019 appeals court decision. That effectively means that if Musk loses the cases, he will not have to pay the defendants’ legal fees, as he would in many states.

Records say Judge O’Connor is a Tesla investor

Another issue has raised concern among legal ethics experts: O’Connor appears to be an investor in Tesla, another company owned by Musk.

It is unclear whether O’Connor has sold his investment of up to $50,000 in Tesla stock, because the judge’s disclosure form covering the 2023 calendar year is not publicly available. He has requested a filing extension, according to an official with the administrative office of U.S. courts who was not authorized to speak on the record.

In May, an NPR investigation found that disclosure forms for judges are often missing, or late, for various reasons. As a result, potential conflicts of interest, like stock holdings or even gifts of luxury travel, are hidden from public view.

Media Matters lawyers have seized on O’Connor’s disclosure, saying rulings on what evidence the judge allows in the case could impact Tesla’s stock price. They argue that testimony or documents revealing Musk’s decision-making process could be made public.

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“Such evidence has the potential to directly harm investor confidence in Musk — and thereby drive down Tesla’s share price. This is not speculation: History has shown that when Musk speaks, Tesla’s stock price responds,” Media Matters lawyer Andrew LeGrand wrote in a June filing.

Josh Blackman, an adjunct scholar at the right-leaning Cato Institute, had a different view, saying the case before O’Connor involves X, not Tesla.

“If the judge owned stock in X, if it were a public company, it’s an easy case,” Blackman said. “It’s a novel case because it requires a chain of inferences to get from X to Tesla.”

But judicial ethics scholar Sample insists the appearance of bias alone is enough to warrant O’Connor to step aside from the case.

He said: “Let another competent judge handle these cases without serious questions surrounding them.”

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Ukrainian drones assault Russian airfield as Kyiv pursues incursion

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Ukrainian drones assault Russian airfield as Kyiv pursues incursion

Moscow declared a state of emergency in two regions after a major Ukrainian drone strike caused large explosions at a military airfield and Kyiv pursued its most ambitious incursion into Russian territory in a decade of war.

The unexpected offensive, which raged into a fourth day on Friday, is the largest attack by Kyiv’s forces on Russian soil, not only since President Vladimir Putin launched his full-scale invasion of Ukraine in 2022, but at least since the Kremlin’s covert invasion of Crimea and the Donbas 10 years ago.

The assault aims to divert Russia’s troops from the east, expose its weaknesses and strengthen Kyiv’s position in future negotiations with Moscow, said an adviser to the government, after months of Russian gains on the more than 1,000km-long front of the grinding war within Ukraine.

A state of emergency was declared in the Russian regions of Kursk and Lipetsk, where Ukrainian forces were engaged in fierce fighting on Friday.

Friday’s drone assault added a complicated new dimension to the incursion, which dwarfs several previous cross-border raids conducted by anti-Moscow Russian volunteer fighters and a far-right militia operating under the command of Ukraine’s military intelligence directorate.

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Some military analysts have questioned the timing of the Kursk operation and the redeployment of some of its elite units at a time when Ukraine’s army is already struggling to defend the frontline in the Donetsk region.

Elements of at least four Ukrainian mechanised and airborne brigades have taken part in the operation so far. In videos verified by the Financial Times and military analysts, they have been seen using US Stryker and German Marder fighting vehicles provided to Kyiv as part of military assistance packages worth billions of dollars.

US and German officials said the armoured vehicles inside Russia had not violated the conditions of their use, despite previous objections by Washington and other western governments to such weaponry being used within Russia over concerns that Moscow might escalate the war.

Gas prices in Russia rose sharply. Kursk contains a crucial transit corridor for gas supply to Europe.

As Kyiv pressed on with its incursion, Russia responded with an attack on a busy supermarket and post office in the eastern Ukrainian city of Kostyantynivka on Friday, which killed at least 12 civilians and injured 44 more, said President Volodymyr Zelenskyy and local authorities.

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The aftermath of a Russian attack on a supermarket in Kostyantynivka, Ukraine, in which at least 12 civilians were killed © Andriy Yermak/Head of the Office of the President of Ukraine

Officials published videos showing black smoke billowing from a destroyed store and first responders working to save shoppers trapped under debris. Another video showed badly wounded people sprawled on the pavement.

The overnight drone attack on Russia was carried out by Ukraine’s security service, the SBU, with the military and special forces early on Friday, a Ukrainian official with knowledge of operations inside Russia told the Financial Times.

The official said the Lipetsk air base — about 300km from the international border and just east of the latest fighting — was targeted “to destroy Russian aviation logistics so that the enemy does not have the opportunity to bomb Ukrainian cities with anti-aircraft missiles”.

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Several warehouses filled with ammunition were detonated, the official said. Videos published on social media and geolocated by the Financial Times showed huge explosions reaching into the night sky.

The Ukrainian official claimed that up to 700 glide bombs stored in the warehouses were damaged or destroyed. Several dozen fighter jets, including Su-34, Su-35 and MiG-31 aircraft, along with military helicopters, were also at the air base, said the general staff of Ukraine’s army.

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“Most of the planes stationed at the military airfield . . . did not have time to take off,” the Ukrainian official claimed. 

The FT could not immediately verify whether the bombs and aircraft had been damaged or destroyed. Russian military bloggers reported that no aircraft were damaged.

Videos shared on Russian Telegram channels showed lines of civilian vehicles stretching several kilometres fleeing east from the Lipetsk and Kursk regions.

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The Ukrainian official said the Lipetsk attack was a follow-up to a Monday assault on the Morozovsk military base in Russia’s Rostov region that had destroyed anti-aircraft missiles and jet fighters. 

Ukraine’s general staff said its forces had also attacked Russian anti-aircraft missile divisions in the occupied territory of eastern Donetsk.

Those attacks came as Ukrainian forces pressed forward with their assault in the neighbouring Kursk region, where the Kremlin has lost control of roughly 350 sq km of territory, according to calculations by the FT and military analysts. 

Alexei Smirnov, the Kursk region’s acting governor, said the situation remained “difficult”. He said his government had declared a state of emergency, was still evacuating residents and was assisting those displaced.

Officials from the Russian emergencies ministry assist residents of the Kursk region, who were evacuated following an incursion of Ukrainian troops
Officials from the Russian emergencies ministry assist residents of the Kursk region, who were evacuated following the incursion by Ukrainian troops © Russian Emergencies Ministry/REUTERS

Pentagon deputy press secretary Sabrina Singh told reporters in Washington on Thursday that Ukraine was “taking action to protect themselves” and that the Biden administration did not see the incursion as escalatory.

Video and photo evidence suggested that Ukraine’s army has moved as deep as 35km into Russia from the international border, down a highway heading north-west. 

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A video circulating on social media that the FT geolocated to a highway in Rylsk showed a destroyed column of Russian military vehicles transporting soldiers that stretched for hundreds of metres. The bodies of several troops are seen in the gruesome video.

A person with knowledge of the operation shared a video with the FT purporting to show a first-person-view (FPV) camera-equipped drone armed with an explosive as it crashed into the tail rotor of a Russian military helicopter.

The person said the SBU was behind the strike — the second Ukrainian FPV drone attack on a Russian helicopter this week. The person said both helicopters crashed as a result of the strikes, but the FT was unable to independently corroborate the claims.

On Friday afternoon, Russian state media aired footage of large convoys of military trucks transporting heavy weaponry towards the fight in Kursk.

Zelenskyy has not explicitly commented on the incursion, but thanked Ukrainian troops on Friday for “destroying the Russian occupiers, holding the frontline, and ensuring that Ukraine remains on the world map”.

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“We are doing our best to provide our warriors with as many opportunities as possible to end this war as soon as possible with a just and lasting peace,” he said.

Andriy Zagorodnyuk, a former Ukrainian defence minister who advises the government, told the FT that Kyiv had planned the operation long in advance.

Zagorodnyuk said its aims included diverting Russian troops fighting elsewhere in Ukraine, as well as bringing the war home to Russians and discouraging them from supporting the war effort.

It also aimed to expose Russia’s weaknesses, including that it was incapable of protecting its own border, and to try to seize the initiative on the battlefield a year after an unsuccessful counteroffensive, and following months of Russian gains.

An image released by the Russian defence ministry showing a Russian air force Su-34 bomber dropping a glide bomb on Ukrainian positions in the Sumy region
An image released by the Russian defence ministry showing a Russian air force Su-34 bomber dropping a glide bomb on Ukrainian positions in the Sumy region © Russian Defense Ministry/AP

⁠Zagorodnyuk said the Ukrainian military was proving its ability to conduct “new tactics of combined arms operation” taught by western military trainers.

He said the aim was not to capture and hold Russian territory “for long”. “We don’t need Russian land,” he said. “We want them to fail on ours.”

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Konrad Muzyka, a military analyst at Rochan Consulting, a Poland-based security group, said the Ukrainian operation could help its position in the war if it forced Russia to divert resources from eastern Donetsk and allowed Kyiv to maintain a presence in Russia’s Kursk region.

That presence might offer a better negotiating position in future, he said.

“If Ukrainian troops, however, are pushed back from the Russian territory without any tangible results with high losses and if Russians continue moving towards Pokrovsk [in Donetsk],” he said, then Ukraine’s top military leadership would be seen as having lost a huge gamble.

“There is no middle ground here. The operation is daring,” he said.

Ukraine separately claimed on Friday to have landed on the Kinburn Spit, a long strip of land jutting into the Black Sea that has been occupied by Russia since March 2022.

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Video footage posted by Ukraine’s military intelligence showed troops landing by jet ski. “The Kinburn spit will be free, like all other temporarily occupied territories of Ukraine,” read an official post on Telegram. 

Additional reporting by Max Seddon in Riga, Anastasia Stognei in Tbilisi and Isobel Koshiw in Kyiv

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