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US policymakers should embrace psychedelic medicine

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US policymakers should embrace psychedelic medicine

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The writer is founding partner of capital fund JourneyOne Ventures based in Los Angeles

The US Food and Drug Administration’s rejection of MDMA-assisted therapy is yet another setback in the global mental health epidemic.

MDMA, commonly known as ecstasy, works by suppressing the fear response, allowing patients who suffer from PTSD to observe and reprocess painful memories. Phase 3 clinical trial data from Lykos Therapeutics, the public benefit corporation that filed the MDMA New Drug Application with the FDA, showed that 71 per cent of participants no longer qualified for a PTSD diagnosis after taking the drug, while 87 per cent had clinically meaningful improvements.

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This is an improvement compared to antidepressants, which on average have a 20-30 per cent complete remission rate and 60 per cent response rate.

MDMA primarily increases the release of serotonin and norepinephrine. Serotonin is crucial for regulating mood, sleep, pain, appetite and other functions, and the increased release of serotonin contributes to MDMA’s mood-elevating effects. It also affects the norepinephrine system, which contributes to emotional excitement, euphoric feelings and cognitive impairment.

The FDA faces many challenges when evaluating psychoactive drugs. It is concerned about abuse of these drugs and has criticised Lykos data. But better mental healthcare treatment is required. Six out of every 100 people in the US will suffer from PTSD at some point in their lives. Yet there have been no new prescription medicines since two antidepressants, Zoloft and Paxil, were approved for this use by the FDA 25 years ago.

MDMA was developed in 1912 by a Merck chemist. It is one of a number of historical healing practices resurfacing as empirical research supports their efficacy.

Egyptian medical papyrus dating back to around 1550BC suggests cannabis may have been used then to treat inflammation, for example. There is also archaeological evidence of psychedelic medicine use in both Central America and Europe.

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Some 40 per cent of the drugs used in western medicine are already derived from plants that have been in use for centuries, including the top 20 best selling prescription drugs in the US today.

We should continue to look backwards in order to move forwards. The current approach towards healthcare is not working. We are not well as a society and the cost is high. Mental illness costs the US economy $282bn a year, according to a study published this year by the National Bureau of Research.

The US is in the grip of a mental health epidemic.

Patients are ready to try alternatives. Last year, a University of Michigan survey found that 80 per cent of adult patients aged 50-80 would be open to stopping one or more of their long-term medications if a doctor said it was possible.

The problem is that once people are on these drugs, withdrawal can be severe. Frontier wellness companies like Outro have developed “hyperbolic tapering”, a process to help people get off of antidepressants with minimal withdrawal while reducing the risk of relapse. Their objective is to create a world where people are empowered to think about their mental illness as recovery, not a life sentence.

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Such innovations require reimagining wellness beyond the status quo. So does psychedelic medicine.

For now, the millions of Americans with PTSD and the patients who aren’t responsive to existing treatments have to bear the burden of waiting for new treatment to be approved.

But this is not a one-off project. The FDA has a pipeline of around 95 psychedelic drugs currently in pre-clinical to phase 3 studies. It makes you wonder what other ground breaking wellness modalities are stuck in regulatory limbo?

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Trump takes on Harris over economic policy at campaign rally

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Trump takes on Harris over economic policy at campaign rally

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Former President Donald Trump held a rally in North Carolina Wednesday in which his economy-focused speech often veered into personal attacks against Kamala Harris. Meanwhile, past comments made by Republican vice presidential candidate JD Vance about women is drawing new scrutiny. NBC’s Garrett Haake reports for TODAY.

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Half Their Land Burned in a Decade: The California Counties Constantly on Fire

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Half Their Land Burned in a Decade: The California Counties Constantly on Fire

The Park fire started in late July outside Chico, Calif., and in just 10 days exploded to become the fourth largest in the state’s history.

A map shows the perimeter of the Park fire as of Aug. 12, 2024. It stretches across Butte County and Tehama County in Northern California.

Three years before, the Dixie fire grew so large that it became the first fire to leap over the Sierra Nevada mountains.

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A map shows the perimeter of the Dixie fire in 2021. It covers much of northern Plumas County, to the northeast of Butte County.

In 2020, the North Complex fires, sparked by lightning in Plumas National Forest, destroyed more than 2,300 structures and killed more than a dozen people.

A map shows the perimeter of the North Complex fires in 2020.

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And in 2018, the Camp fire razed the town of Paradise and killed 85 people, becoming the state’s deadliest fire to date.

A map shows the perimeter of Camp fire in 2018, which spread mostly in Butte County.

These four historic California fires burned in Butte County, which, along with neighboring counties near the foothills of the Sierras, has in the past decade seen much of its land engulfed in flames.

A map shows perimeters of all wildfires since 2014.

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Since 2014, fires have burned through nearly forty percent of Butte County, according to a New York Times analysis of wildfire perimeters. An even larger share has burned in two neighboring counties, Plumas and Tehama, and in counties farther to the west, including in the heart of wine country.

Sources: National Interagency Fire Center and Cal Fire.

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Note: A fire’s perimeter is defined as its entire outer edge or boundary, but that does not necessarily mean that the entire area within the perimeter was completely burned. Counties are shown with their relative sizes.

By The New York Times

Fires, of course, don’t know or stick to county lines. But calculating the share of counties affected by wildfires can provide insight into the growing wildfire risk statewide and across the American West.

The area that burned in Butte and Plumas Counties is more than four times as large as the area that had burned in the previous decade, the Times analysis shows, and the area burned in Tehama is more than five times as large. Over the past decade, most California counties have seen double the area burned compared with the area burned in the previous decade.

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It’s not necessarily the case that more large fires are burning now than in previous decades, but the ones that do ignite are charring through much more land, according to Tirtha Banerjee, a professor and wildfire researcher at the University of California, Irvine. “What that says to me is that fires are getting more intense and more severe, and behaving in more unexpected ways,” he said.

A warming climate has fueled bigger and hotter wildfires, with increasingly intense spells of heat and drought turning forests into tinderboxes. The fire season arrives earlier in the year and lasts longer.

In California, decades of fire suppression policies have exacerbated the issue, leaving behind overgrown thickets of vegetation. Much of the area in the Park fire’s path, for example, hadn’t been burned for decades or longer, said Taylor Nilsson, the director of Butte County’s Fire Safe Council. That allowed large amounts of dense vegetation to accumulate, providing ample fuel for the fire.

Climate change and forest management are not the only risk factors. There is inevitably a bit of luck involved: High wind speeds can enable fires to spread farther and more rapidly.

All fires also require a spark in order to ignite. The movement of people into fire-prone areas near forests, grasslands and shrublands has bent that element of luck, making it more likely that a fire will spark.

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While lightning caused several recent wildfires of historic proportions, human activity is the source for a vast majority of ignitions in the U.S. Of the 20 largest wildfires in California, seven were caused directly by people, and three by damaged power lines.

20 Largest Fires in California History

People were responsible for many of the state’s largest wildfires.

Fire Year Acres Official cause Counties
1 August Complex 2020 1,032,648 Lightning Mendocino, Humboldt, Trinity, Tehama, Glenn, Lake and Colusa
2 Dixie 2021 963,309 Power lines Butte, Plumas, Lassen, Shasta and Tehama
5 S.C.U. Lightning Complex 2020 396,625 Lightning Stanislaus, Santa Clara, Alameda, Contra Costa and San Joaquin
6 Creek 2020 379,895 Undetermined Fresno and Madera
8 North Complex 2020 318,935 Lightning Butte, Plumas and Yuba
9 Thomas 2017 281,893 Power lines Ventura and Santa Barbara

Source: Cal Fire

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Note: Data accessed on Aug. 12, 2024. The Park fire is still active, and its acreage count is not final. Acres burned for the Rush fire includes areas in California and Nevada.

California’s wildfire history is punctuated by both “good” and “bad” fire seasons, but the overall size of burned areas has trended upward. In recent decades, quieter fire seasons have been followed by explosive and destructive ones. Often, a small number of extraordinarily large fires account for much of the area burned in a year.

Acres Burned by Wildfires in California

Source: Cal Fire

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Note: Data accessed on Aug. 12, 2024.

By The New York Times

This year, the number of acres burned by wildfires has more than doubled from the previous year. Two years of wet winters in 2022 and 2023 likely contributed to vegetation growth and the buildup of fuel, said Alex Hall, the director of the Center for Climate Science at the University of California, Los Angeles. Intense heat in the weeks before the Park fire sparked — most days in July in Chico climbed over 100 degrees Fahrenheit — greatly accelerated the drying process.

There are still several months left in this year’s fire season. On Aug. 1, the National Interagency Fire Center, which helps to coordinate federal fire response, issued new warnings about fire risk for this season, saying that it expects much of California and the Western United States to be under significant threat through at least the end of September.

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UK economy expands 0.6% in second quarter

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UK economy expands 0.6% in second quarter

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The UK economy grew 0.6 per cent in the second quarter, in only a marginal slowdown from the robust growth of the previous three months, providing some good news for the new Labour government.

The quarter-on-quarter change in the GDP figure from the Office for National Statistics on Thursday compared with 0.7 per cent growth in the first three months of the year and was in line with economists’ expectations.

Monthly GDP growth was zero in June following a 0.4 per cent expansion in May, the ONS said. The figure was in line with analysts’ expectations.

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Hailey Low, economist at the National Institute of Economic and Social Research, said the GDP figures “signal that growth remains on course, building on Q1’s strong performance”.

But she added: Persistent challenges such as low productivity growth, strained public finances and inadequate infrastructures have acted as barriers to achieving sustained growth.”

Prime Minister Sir Keir Starmer has placed growth at the centre of his economic agenda, promising to “take the brakes off Britain”.

Responding to the GDP data, chancellor Rachel Reeves said the government was “under no illusion as to the scale of the challenge we have inherited after more than a decade of low economic growth”.

Reeves argues that unless she can boost Britain’s long-term growth rate, the country will be trapped in a “doom loop” of high taxes and poor public services.

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But Jeremy Hunt, former Conservative chancellor, said: “Today’s figures are yet further proof that Labour have inherited a growing and resilient economy.”

“The chancellor’s attempt to blame her economic inheritance on her decision to raise taxes — something she had always planned — will not wash with the public.”

Sterling nudged higher following the ONS release. The pound climbed 0.2 per cent against the US dollar to $1.285. 

The yield on the interest rate-sensitive two-year gilt rose 0.03 percentage points to 3.58 per cent.

Ashley Webb, economist at consultancy Capital Economics, noted that the 0.6 per cent figure was marginally lower than the 0.7 per cent forecast by the Bank of England.

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“At the margin, this may give the bank a bit of reassurance that the recent strength of activity won’t prevent further falls in services inflation,” he added.

Separate ONS data published on Wednesday showed services inflation, a crucial gauge of domestic price pressures in the eyes of interest rate-setters, fell more than expected to 5.2 per cent in July from 5.7 per cent in June.

The UK economy entered a technical recession at the end of last year after being hit by high inflation and borrowing costs. However, it returned to growth this year, helped by stronger household spending as price pressures and mortgage rates declined.

In August, the BoE upgraded its GDP growth forecast for this year to 1.25 per cent from just 0.5 per cent owing to stronger-than-expected activity in the first half of the year.

It expects quarterly GDP growth to fall back to 0.4 per cent and 0.2 per cent in the third and fourth quarters, respectively.

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Suren Thiru, economics director at the ICAEW professional body, said: “This current pace of economic growth is unlikely to be maintained in the second half of the year as weaker wage growth, high interest rates and persistent supply constraints limits output.”

Services grew 0.8 per cent in the three months to June, with widespread offsetting falls of 0.1 per cent in the production and construction sectors.

GDP per head, which matters for living standards, posted the second consecutive quarterly expansion, but it remains below the level of the same quarter last year following seven quarters of contraction.

In the second quarter, there were increases in gross capital formation, government consumption and household spending, partially offset by falls in net trade.

Bar chart of Contribution to GDP growth, % points showing UK growth was helped by increases in gross capital formation, government consumption and household spending

In June growth was flat, driven by a fall in services owing to a weak month for health, retailing and wholesaling. The health sector was affected by the junior doctors’ strike, while wet weather hit sales.

The UK’s GDP quarter-on-quarter figure for the three months to June compares with a 0.3 per cent expansion in the Eurozone and 0.7 per cent growth in the US.

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