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A person wearing a disposable face mask with the words “justice for immigrants” written it. Kevin Dietsch/Getty Images

  <figcaption>An immigration activist participates in a rally near the White House on October 7.</figcaption>

He backed Democrats’ latest but so far unsuccessful attempt to include a pathway to citizenship for certain categories of immigrants — including Dreamers who came to the US as children, TPS recipients, farmworkers, and essential workers — in a budget reconciliation bill. His administration also recently published a proposed regulation seeking to codify protections for Dreamers who have been allowed to live and work in the US under the Deferred Action for Childhood Arrivals program, which is meant to guard against ongoing legal challenges.

Biden has also attempted to expand legal aid resources for immigrants and limit the reach of immigration enforcement inside the US. The administration recently launched an initiative to provide unaccompanied children facing deportation with a government-funded lawyer in eight cities across the US, and has also sought to narrow the categories of undocumented immigrants who should be prioritized for arrest, issuing new US ICE guidance meant to focus resources on those who pose public safety threats. And on Tuesday, the administration ended mass worksite raids, which the Trump administration used to arrest hundreds of undocumented immigrants at once.

Such policies, Psaki said during a September 20 briefing, show that Biden remains “absolutely committed” to “putting in place long-overdue measures to fix our immigration system — to make it more moral, humane, and workable.”

But his actions on the border have told a different story: a push to improve the lives of only certain immigrants who are already integrated into American society, while keeping others out of sight and out of mind — even if that means embracing policies designed by the Trump administration.

Of course, not everyone is pleased that these startups could make psychedelics more mainstream. Some think these companies are capitalizing on a medical pathway for psychedelics that could ultimately exclude recreational users and make psychedelics more expensive and inaccessible. Others believe that psychedelics are being marketed as a cure-all that current research doesn’t support.

“Our experience with so-called pain clinics peddling untold amounts of opioids should be a cautionary tale,” Kevin Sabet, a former White House drug policy adviser who opposed legalizing cannabis, told Recode. “The psychedelics fad has reached a fever pitch far above and beyond what science tells us. We cannot forget the harmful potential and opportunity for manipulation by massive corporate interests.”

Nevertheless, it seems clear that the movement to make psychedelic therapy an accepted mental health treatment is gaining momentum.

A psychedelics renaissance could be coming

The origins of the government’s apprehensive approach to psychedelic-based mental health treatment stretch back decades. In the 1950s and ’60s, the federal government invested heavily into researching drugs like LSD and psilocybin. But after the Controlled Substances Act of 1972, federal funding into the possible benefits of psychedelics quickly evaporated.

That stance may be changing. In September, researchers at Johns Hopkins University received funding from the National Institute on Drug Abuse to investigate whether psilocybin could help people quit cigarettes. it appears to be the first federally funded direct study in decades of the mental health benefits of a traditional psychedelic drug. At the same time, the DEA, which keeps tight caps on how much psychedelics are available to US researchers, recently proposed increasing the nationwide availability of psilocybin from 30 grams to 1,500 grams.

Packets of ketamine in a 
tray. Cole Burston/AFP via Getty Images
Ketamine can be taken in the form of a lozenge, an IV, a nasal spray, or an intramuscular shot.

There is also a growing number of efforts to make psychedelics more widely available not only to researchers but also to patients. In the last few years, Denver, Oakland, and Washington, DC, have decriminalized psilocybin, and in 2023, supervised psilocybin-based therapy will become legal in Oregon. Meanwhile, a psilocybin regimen for depression is in phase 2 trials, and an MDMA-assisted treatment for people with severe PTSD is currently in phase 3 clinical trials. The FDA has also already approved a Johnson & Johnson drug called Spravato, a nasal spray that’s derived from ketamine, to treat depression.

In anticipation of looser regulations, there’s a burgeoning psychedelic health care industry made up of companies that want to offer psychedelic treatments or develop new drugs based on psychedelic compounds. In addition to Field Trip, there are 31 publicly traded firms focused on psychedelics, and at least 18 more that are still private, according to the psychedelics industry tracker Psilocybin Alpha. Inspired by promising but limited research showing that psychedelics can help treat not only treatment-resistant depression but also addiction and end-of-life anxiety, venture capitalists, including Peter Thiel, have poured hundreds of millions of dollars into these companies.

“There’s a lot of enthusiasm. And that makes sense because there are many people who have suffered for many years for whom this has brought relief,” Sharmin Ghaznavi, an associate director of Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics, told Recode. “But we have a lot that we need to learn, and we owe that to our patients.”

The government has been slow to support research into the potential benefits of psychedelics. That means philanthropies and private companies have funded almost all of the recent studies into the medical applications of drugs like MDMA and psilocybin. Many of those studies come with important caveats, including small sample sizes and unrepresentative patient pools. One 2018 analysis of 18 psychedelics studies found that 82 percent of the participants were white.

But even as research into psychedelics continues, companies are already developing everything from apps for guided trips and mushroom-facilitated retreats to psychedelic-assisted virtual reality experiences. After all, as with any big pharmaceutical breakthrough, the future of psychedelics could be extremely profitable.

How Field Trip plans to get ahead

Field Trip is well on its way to being a major player in the psychedelic health care industry. A centerpiece of Field Trip’s plan is the design of its clinics. The idea, the company says, is that psychedelics will need a brand new environment for medical care. Doctors’ offices are too sterile, and therapists’ offices don’t have the medical staff, time, or equipment to monitor patients. After all, trips on more intense psychedelic drugs require several hours and lots of supervision.

That’s why, at Field Trip’s New York location, there are serene rooms with reclining chairs and headphones for patients to use during their exploration sessions. Because ketamine can increase blood pressure, there are blood pressure monitors on-site, too. There are also rooms for post-trip reflection, where there are soft fur rugs, easels for drawing, and a gong. The space also includes a wall covered in live moss, a bubble-blowing machine, and several copies of Michael Pollan’s influential book about psychedelics, How to Change Your Mind.

“There’s lots of shoe companies out there, but Nike has a very prominent voice in that conversation,” Field Trip CEO Ronan Levy told Recode. “I want Field Trip to do that for psychedelics.”

    <img alt="The interior of a Field Trip clinic featuring floor cushions and a live moss wall." 
src=“https://cdn.vox-cdn.com/thumbor/LFlIl4xhOshIPOnYEBW2bouV9rA=/800x0/filters:no_upscale()/cdn.vox- cdn.com/uploads/chorus_asset/file/22922244/GettyImages_1230122272.jpg” /> Cole Burston/AFP via Getty Images
Field Trip hopes to open 75 clinics by 2024.

While the company had about $100 million on hand at the end of June, Field Trip is currently making less than $1 million on patient services, according to its most recent quarterly report. One of the biggest challenges for Field Trip is that most people don’t have several thousand dollars lying around to spend on ketamine therapy. But if the FDA were to approve a psychedelic drug for a mental health condition, insurance companies may start to cover more Field Trip treatments, bringing them a huge new customer base.

There are certain conditions, like a history of psychosis or a ketamine allergy, that rule out Field Trip’s offering for some patients. Levy says the safety of ketamine has been well established and that Field Trip hasn’t had any medical issues. But others believe there is a litany of open questions.

Jeffrey Lieberman, a Columbia psychiatry professor, says the enthusiasm about psychedelics is outpacing the science, and he worries that mishaps could lead to backlash and a return to restrictions. If MDMA is approved for PTSD, for example, companies could end up prescribing the drug for other conditions that it hasn’t been approved for. That practice, which is sometimes called off-label prescribing, is already in place for ketamine. Lieberman added that we don’t fully understand the long- term safety of ketamine. There is also evidence ketamine clinics throughout the US are overhyping the drug’s abilities and not properly screening patients, acccording to a 2018 investigation by STAT.

There are other objections. A significant number of people oppose even the monitored use of psychedelics, including the 44 percent of Oregon residents who voted against the state’s recent measure to legalize a supervised psilocybin therapy model much like Field Trip’s. There are also psychedelic advocates who believe that allowing companies like Field Trip to do business will end up medicalizing and driving up the cost of psychedelics, which they think should be freely available.

The companies and people hoping to make psychedelic-based mental health care mainstream say this trend is about far more than just the drugs themselves.

“Taking a gram of mushrooms recreationally with your friends sitting around and giggling at YouTube music videos … it’s harmless,” Sanjay Singhal, a tech entrepreneur who directs the Nikean Foundation, a nonprofit that funds psychedelics research, told Recode. “But it’s completely different from taking five grams, knocking you out in the presence of a therapist for five hours while your brain processes whatever trauma, anxiety, emotional issues you might have.”

We’re bound to hear more about psychedelic therapy in the months to come. But even if psychedelics’ legal status remains the same, it’s clear to some patients that there’s a place for psychedelic therapy — even if it’s just the existing ketamine treatments — in our health care system. To Chewning, the veteran, these startups are addressing the demand for better mental health care and providing a new option for people who haven’t had success with traditional medications and therapy.

“I just look at what they’ve done for me personally, I look at what they have done for people I know,” he said. “We’re being put on a path toward a higher quality of life in the near future.”

The pharma giant said its new antiviral drug cut hospitalizations in half for at-risk Covid-19 patients.

The Food and Drug Administration may soon authorize the first pill to treat Covid-19 after the pharmaceutical giant Merck reported strong results from its antiviral drug molnupiravir earlier this month. On Monday, Merck filed for an emergency use authorization from the FDA, which would allow doctors to begin prescribing the drug. Based on the approval timeline for past Covid-19 drugs, the FDA could make a decision within days or weeks.

Clinical trials showed that the drug reduced the risk of hospitalization and death in at-risk patients by 50 percent, according to the company’s interim analysis.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, CEO and president of Merck, in a statement.

A new and effective Covid-19 treatment — if approved by health regulators — could be a versatile tool for doctors to treat Covid-19 patients and could ultimately save lives. While there are a number of treatments for Covid-19 on the market, many of them are expensive, difficult to administer, not widely available, or only marginally effective. Meanwhile, treatments that have little evidence behind them, like the antiparasitic drug ivermectin and the anti- malaria drug hydroxychloroquine, have gained traction in some circles.

Molnupiravir, originally developed to treat influenza, could solve many of these challenges. It’s administered as a twice-a-day pill for five days, compared to other Covid-19 treatments that require expensive intravenous transfusions, such as monoclonal antibodies and convalescent plasma. The antiviral drug remdesivir, currently the only drug with full Food and Drug Administration approval to treat Covid-19, also has to be delivered into the bloodstream.

A drug like molnupiravir (the name is a reference to Thor’s hammer, Mjölnir) could also help compensate for persistent gaps in Covid-19 vaccination coverage, both in the United States and abroad.

However, the results were announced in a company press release, which carries less scientific weight than a peer-reviewed paper or even a pre-print article that lays out the data for outside scientists to examine. Merck’s findings did come from a randomized phase 3 clinical trial of 775 adult Covid-19 patients. The participants had mild to moderate disease and were deemed to be at-risk but not hospitalized when the trial began in early August.

By day 29 of the trial, 7.3 percent of patients who received molnupiravir had died or were hospitalized, compared to 14.1 percent of patients who were in the placebo group (meaning they did not receive the drug). Merck says molnupiravir was also effective against coronavirus variants, including gamma, delta, and mu. The trial was halted, with the approval of regulators, once these results showed the drug’s effectiveness.

A group of independent experts saw the data and said “we’ve seen enough”

And stopped the trial because the drug was clearly working

That’s important verification

It also makes me far more optimistic about other similar therapies being studies for COVID will pan out

3/4

— Ashish K. Jha, MD, MPH (@ashishkjha) October 1, 2021

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” said Davis.

The federal government is already planning for its potential approval: It has committed to buying 1.7 million courses of molnupiravir treatments for $1.2 billion (about $700 per course), and production of the drug has already begun. Ridgeback Biotherapeutics and Merck expect to make 10 million courses of the drug by the end of the year.

It could still be weeks or months before most people will have access to the little brown pill. And even when it is available, there may still be holdouts resistant to getting treated for the disease.

How Merck’s new antiviral drug molnupiravir works

Viruses are tricky beasts to corner. They are passive parasites and can’t reproduce without hijacking the machinery of a host cell. That makes it really difficult to come up with a drug that can interfere with a virus’s life cycle without also causing collateral damage to healthy human cells. And because viruses mutate so quickly, an effective treatment can become less so over time.

Compare that to bacteria, which contain all the biological hardware they need to make copies of themselves. Their machinery is different enough from human cells that the class of drugs known as antibiotics can kill off many bacteria with minimal damage to humans.

Molnupiravir works a lot like the antiviral drug remdesivir (-vir is a suffix commonly used for antiviral drugs). The SARS-CoV-2 virus, which causes Covid-19, makes copies of itself by encoding instructions on RNA, which is made up of “base” molecules identified by the letters A, C, U, and G. While remdesivir imitates A (adenosine), molnupiravir can mimic U (uracil) or C (cytosine).

When the virus incorporates remdesivir into its RNA, the drug causes its reproductive cycle to stall. Molnupiravir works a little differently, causing genetic mutations that hamper the virus.

Crucially, these drugs can fool the virus, but they don’t fool human cells, so they have a targeted effect and for the most part leave the human cells alone.

Merck didn’t note any specific side effects from molnupiravir in its press release and said the rate of complications was similar between the placebo group and the treatment group in the clinical trial. Unspecified side effects occurred in 35 percent of molnupiravir recipients but occurred in 40 percent of the placebo group.

Molnupiravir faced some of controversy in earlier stages of development. Several researchers previously raised concerns that molnupiravir’s mechanism could lead to some unanticipated problems. Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, alleged in a whistleblower complaint last year that his agency was pressured into funding the manufacture of the drug (then known as EIDD-2801) before they received adequate safety data. The FDA tends to pay close attention to safety concerns as it evaluates drugs for emergency use.

3/5 one concern that it introduces virus mutations or potential mutagenic probably means it won’t be recommended in pregnancy. I seem to remember my good colleague @RickABright had a concern about this drug when he was at BARDA so maybe he can comment. Also important to remember

— Prof Peter Hotez MD PhD (@PeterHotez) October 1, 2021

Molnupiravir fills in a crucial gap in the response to Covid-19

While the US has multiple highly effective vaccines that help our immune systems fight Covid-19, the vaccination rate has slowed and many holdouts remain. At the same time, many other countries still don’t have access to enough vaccines. The unvaccinated continue to make up the majority of hospitalizations and deaths, with fatalities currently around 2,000 per day in the US alone.

Treatments for Covid-19, therefore, remain a vital component of the response to the pandemic. But developing new drugs to treat an illness is expensive and time-consuming, which is why researchers have been eager to find off-the-shelf therapies that have already been deemed safe to use against other ailments. Some have proven fruitful, like the corticosteroid dexamethasone. Scientists have also seen promise in the antidepressant drug fluvoxamine as a therapy.

New drugs like molnupiravir require more testing and review, but they offer the possibility of a stronger, more targeted approach. A drug like molnupiravir could be especially useful because it is administered in the early stages of the disease. Since it’s just a pill, it may spare the patient a trip to a clinic for a transfusion for treatments like monoclonal antibodies. That reduces the chances of an infected patient transmitting the virus to medical staff, and it averts potential complications associated with transfusions.

And while $700 for a course of molnupiravir isn’t exactly cheap, a transfusion setup alone can cost $1,000, and that’s on top of the cost of the drugs delivered intravenously. A course of monoclonal antibodies can cost $2,100, while remdesivir can cost $3,100.

Pills are also much easier to store and transport than transfused drugs, so they can reach more remote areas with fewer resources.

That’s why some of the biggest effects of molnupiravir could occur in other countries, particularly in places where Covid-19 vaccines have yet to gain much of a foothold. Merck said it is setting up tiered pricing for molnupiravir, meaning that it could cost less in other countries, and is licensing its production to five generic drug manufacturers in India to build up its supplies.

Treatments do help people get better — but it’s important to remember that vaccination remains the most effective tactic for controlling the pandemic. Vaccination can prevent sickness in the first place, and even the most expensive vaccines are dirt cheap compared to most therapies for the disease. The initial two doses of the Pfizer/BioNTech vaccine and the Moderna vaccine cost about $50.

Other measures beyond drugs remain critical too. Wearing masks, social distancing, and testing for Covid-19 are still effective, and the arrival of an effective drug won’t be a reason to let our guard down. The existing pillars of pandemic response will remain crucial to keeping this deadly disease in check.

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