Tagged Washington

New Legal Push Aims to Speed Magic Mushrooms to Dying Patients

Back in March, just as anxiety over COVID-19 began spreading across the U.S., Erinn Baldeschwiler of La Conner, Washington, found herself facing her own private dread.

Just 48 and the mother of two teenagers, Baldeschwiler was diagnosed with stage 4 metastatic breast cancer after discovering a small lump on her chest, no bigger than a pea. Within weeks, it was the size of a golf ball, angry and red. Doctors gave her two years to live.

“It’s heartbreaking,” she said. “Frankly, I was terrified.”

But instead of retreating into her illness, Baldeschwiler is pouring energy into a new effort to help dying patients gain legal access to psilocybin — the mind-altering compound found in so-called magic mushrooms — to ease their psychic pain.

“I have personally struggled with depression, anxiety, anger,” Baldeschwiler said. “This therapy is designed to really dive in and release these negative fears and shadows.”

Dr. Sunil Aggarwal, a Seattle palliative care physician, and Kathryn Tucker, a lawyer who advocates on behalf of terminally ill patients and chairs a psychedelic practice group at Emerge Law Group, are championing a novel strategy that would make psilocybin available using state and federal “right-to-try” laws that allow terminally ill patients access to investigational drugs.

They contend that psilocybin — whether found in psychedelic mushrooms or synthetic copies — meets the criteria for use laid out by more than 40 states and the 2017 Right to Try Act approved by the Trump administration.

“Can you look at the statute and see by its terms that it applies to psilocybin?” Tucker said. “I think the answer is yes.”

Still, the pair admit they’re pushing a legal theory still untested in the courts. “This is untrodden ground,” Aggarwal said.

This month, Aggarwal, who works at the Advanced Integrative Medical Science Institute, known as AIMS, took the first step toward federal authorization of the substance in Washington state and perhaps across the nation. He submitted an application to manufacture psilocybin to the state’s Pharmacy Quality Assurance Commission, which would allow him to grow psilocybin mushrooms from spores at his clinic and administer them for therapeutic use.

Commission members haven’t yet reviewed the application, but Gordon MacCracken, an agency spokesperson, said there “would be a path” for possible license and use — if the application meets the requirements of state regulators and the federal Drug Enforcement Administration.

Currently, psilocybin use is illegal under federal law, classified as a Schedule 1 drug under the U.S. Controlled Substances Act, which applies to chemicals and substances with no accepted medical use and a high potential for abuse, such as heroin and LSD.

Recently, however, several U.S. cities and states have voted to decriminalize possession of small amounts of psilocybin. This month, Oregon became the first state to legalize psilocybin for regulated use in treating intractable mental health problems. The first patients will have access beginning in January 2023.

It’s part of a wider movement to rekindle acceptance of psilocybin, which was among psychedelic drugs vilified — and ultimately banned — after the legendary counterculture excesses of the 1960s and 1970s.

“I think a lot of those demons, those fears, have been metabolized in the 50 years since then,” Aggarwal said. “Not completely, but we’ve moved it along so that it’s safe to try again.”

He points to a growing body of evidence that finds that psilocybin can have significant and lasting effects on psychological distress. The Johns Hopkins Center for Psychedelic and Consciousness Research, launched this year, has published dozens of peer-reviewed studies based on two decades of research. They include studies confirming that psilocybin helped patients grappling with major depressive disorder, thoughts of suicide and the emotional repercussions of a cancer diagnosis.

Psilocybin therapy appears to work by chemically altering brain function in a way that temporarily affects a person’s ego, or sense of self. In essence, it plays on the out-of-body experiences made famous in portrayals of America’s psychedelic ’60s.

By getting out of their heads — and separating from all the fear and emotion surrounding death — people experience “being” as something distinct from their physical forms. That leads to a fundamental shift in perspective, said Dr. Ira Byock, a palliative care specialist and medical officer for the Institute for Human Caring at Providence St. Joseph Health.

“What psychedelics do is foster a frame shift from feeling helpless and hopeless and that life is not worth living to seeing that we are connected to other people and we are connected to a universe that has inherent connection,” he said.

“Along with that shift in perspective, there is very commonly a notable dissolution of the fear of dying, of nonexistence and of loss, and that’s just remarkable.”

The key is to offer the drugs under controlled conditions, in a quiet room supervised by a trained guide, Byock said. “It turned out they are exceedingly safe when used in a carefully screened, carefully guided situation with trained therapists,” he said. “Almost the opposite is true when used in an unprepared, unscreened population.”

Baldeschwiler is one of many cancer patients eager to undergo psilocybin therapy to help quell the psychic pain that can accompany a terminal illness. Advocates say the therapy appears to work by temporarily altering brain function in a way that affects a person’s sense of self, helping them separate from the fear and emotion surrounding death.(Dan DeLong for KHN )

Baldeschwiler is one of several AIMS cancer patients eager to undergo psilocybin therapy. Another is Michal Bloom, 64, of Seattle, who was diagnosed in 2017 with stage 3 ovarian cancer. The anxiety of living with the terminal disease is overwhelming, she said.

“It’s as if someone came up to you, put a gun to the back of your head, whispered, ‘I have a gun to your head and I’ll have a gun to your head for the rest of your life. I may pull the trigger, I may not,’” she said. “How do you live like that?”

Research shows that a single six-hour session of psilocybin therapy may be enough to quell that fear, Aggarwal said. “I’m really interested in a right-to-try approach because it’s really what we need for patients right now,” he said.

Under the state and federal laws, to be eligible for “right-to-try” status, a treatment must have completed a phase 1 clinical trial approved by the federal Food and Drug Administration, be part of active clinical trials and in ongoing development or production.

So far, psilocybin ticks all those boxes, Tucker said.

The FDA has granted “breakthrough therapy” status to psilocybin for use in U.S. clinical trials conducted by Compass Pathways, a psychedelic research group in Britain, and by the Usona Institute, a nonprofit medical research group in Wisconsin. More than three dozen trials are recruiting participants or completed, federal records show.

But access to the drug remains a hurdle. Though psychedelic mushrooms grow wild in the Pacific Northwest and underground sources of the drug are available, finding a legal supply is nearly impossible.

Tucker and Aggarwal asked Usona last summer for a supply of the synthetic psilocybin its researchers produce for clinical trials, but so far have received nothing. Penny Patterson, a Usona spokesperson, said there’s been no “definitive resolution” and that conversations are continuing.

The firm’s reluctance may reflect a larger unease with employing right-to-try laws to speed use of psilocybin, said Dr. Anthony Back, a palliative care physician at the University of Washington.

Back supports the use of psilocybin for cancer patients and has even tried the drug to better understand the experience. But he said using psilocybin outside of formal clinical trials might endanger Usona’s ability to get traditional FDA approval. Adverse events may occur that will have to be reported to the FDA, an agency already watching the research closely.

“I can see why they’re hesitant, to be honest,” Back said. “I think right-to-try is an uphill battle.”

Still, Tucker and other advocates say it’s a battle worth fighting. End of Life Washington, a group focused on helping terminally ill patients use the state’s Death With Dignity Act, recently published a policy that supports psilocybin therapy as a form of palliative care. Other treatments for anxiety and depression, such as medication and counseling, may simply not be practical or effective at that point, said Judith Gordon, a psychologist and member of the group’s board of directors.

“When people are dying, they don’t have the time or the energy to do a lot of psychotherapy,” she said.

Baldeschwiler agrees. With perhaps less than two years to live, she wants access to any tool that can ease her pain. Immunotherapy has helped with the physical symptoms, dramatically shrinking the size of the tumor on her chest. Harder to treat has been the gnawing anxiety that she won’t see her 16-year-old daughter, Shea McGinnis, and 13-year-old son, Gibson McGinnis, become adults.

“They are beautiful children, good spirits,” she said. “To know I might not be around for them sucks. It’s really hard.”

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Trump’s Lame-Duck Status Leaves Governors to Wing It on COVID

Not long after the world learned that President Donald Trump had lost his reelection bid, states began issuing a new round of crackdowns and emergency declarations against the surging coronavirus.

Taking action this time were Republican governors who had resisted doing so during the spring and summer. Now they face an increasingly out-of-control virus and fading hope that help will come from a lame-duck president who seems consumed with challenging the election results.

President-elect Joe Biden has promised a more unified national effort once he takes office on Jan. 20, and pressure is building on Congress to pass a new financial relief package. But with record hospitalizations and new cases, many governors have decided they can’t afford to wait.

“I don’t know any governor who’s sitting there waiting for the knight to come in on the horse,” said Lanhee Chen, a fellow at the Hoover Institution and a former senior health official in President George W. Bush’s administration. “There’s no way for these guys to just sit and wait. The virus and the crisis is getting worse hour by hour, day by day.”

As new measures trickle out across states, public health policy experts worry many don’t go far enough. For those states attempting to impose meaningful restrictions, their success depends on cooperation from a population with pandemic fatigue. And people may be reluctant to curtail their holiday gatherings.

Residents of many conservative states don’t acknowledge the depth of the health problem, especially given Trump and some of his allies have stressed the crisis is being overplayed and will end quickly.

The bottom line is that many people just aren’t sufficiently scared of the virus to do what must be done to stop the spread, said Rodney Whitlock, a health policy consultant and former adviser to Sen. Chuck Grassley (R-Iowa).

“You’re dealing with folks there who definitely put liberty over everything else because they’re not afraid enough,” Whitlock said. “Even in the face of cases, even in the face of people around them getting it. They’re just not afraid.”

Among the first governors to act was outgoing Utah Gov. Gary Herbert. The day after The Associated Press called the presidential election for Biden on Nov. 7, the Republican announced Utah’s first-ever statewide mask mandate and clamped down on social gatherings and other activities until Nov. 23.

“All of us need to work together and see if there’s a better way,” Herbert said in a news conference.

Republican and Democratic governors alike followed with measures of their own in Colorado, Iowa, Michigan, Nebraska, New York, Ohio, Oregon, Pennsylvania, Washington and other states. Strategies included partial lockdowns, limits on crowds, canceling in-person classes for schools and reducing hours and capacity for bars and restaurants.

Health policy experts largely agree that the virus’s spread, not the end of the election, is what’s driving these changes — though the end of the campaign season does take political pressure off governors inclined to issue COVID-preventive policies.

“It’s much easier to act when you don’t have attention on you than when you do, but I would hope that the action is taking place regardless of what the political circumstances are,” Chen said.

No state has yet resorted to the sort of full lockdowns enacted in the spring, which resulted in mass business closures and layoffs and sent the economy crashing.

Christopher Adolph, an associate professor at the University of Washington, and his team with the university’s COVID-19 State Policy Project have been studying states’ responses to the pandemic. Some states have made a show of taking action, without much substance behind it, he said. For example, Alaska Gov. Mike Dunleavy, a Republican, declared an emergency on Nov. 12 — but only recommended, not ordered, that people wear masks and maintain social distance.

Other governors first took small steps only to follow up with tighter restrictions. In Iowa, for example, Republican Gov. Kim Reynolds, who opposed mask mandates during the presidential campaign, initially announced that all people over age 2 would be required to wear masks at gatherings of certain sizes. On Nov. 16, she issued a simpler but stricter three-week statewide mask mandate.

North Dakota Gov. Doug Burgum, a Republican, also ordered mandatory face coverings for the first time. Hospitals there have been reporting they have more patients than capacity, and the state has been leading the country in new per capita COVID cases.

At the very least, each state should make it clear that people must not gather indoors, Adolph said. Restaurants, bars, gymnasiums and large indoor events should be closed, he said, and gatherings inside people’s homes should not happen.

“We’re not seeing enough clear, broadly communicated, well-stated, unambiguous policies,” Adolph said.

An exception is Herbert, one of two governors who will leave office in January. The two-term Utah governor will turn over the reins to his current lieutenant governor, Spencer Cox, who has been a part of the state’s response to the pandemic since the beginning. Both Republicans have promised a smooth, seamless transition between administrations.

The nation’s other lame-duck governor is Montana’s Steve Bullock, a Democrat. But unlike Herbert, the term-limited Bullock will be replaced by a governor from a different party. Republican U.S. Rep. Greg Gianforte defeated Bullock’s lieutenant governor, Mike Cooney, in the Nov. 3 election. And Bullock lost his bid for the U.S. Senate.

Bullock said in a Nov. 12 news conference that he would not take additional COVID-intervention measures without a federal aid package to blunt the economic fallout. Five days later, he reversed himself to expand a previous mask requirement and limit capacity and hours in bars, restaurants and other entertainment venues.

Gianforte has not directly answered whether he would continue Bullock’s restrictions. When asked, the governor-elect has spoken instead of personal responsibility and reopening the economy while protecting the most vulnerable people. In July, he referenced the unfounded hope that the virus would be slowed by the U.S. reaching “herd immunity” by the end of the year.

Another obstacle is that a district judge essentially ruled Bullock’s mask mandate unenforceable. State health department lawyers had asked District Judge Dan Wilson to enforce the mandate against five businesses accused of flouting the measure.

“The businesses and the owners have been put on the front line of implementing a state policy that has more exceptions than directives and would be about as effective in bailing water from the leaky boat of our present health circumstances as would a colander,” the judge said in denying the request.

That leaves Bullock with the task of managing a crisis in his final weeks of office with local officials already looking past him to a new administration.

In Flathead County, where the five businesses were sued for violating the mask mandate, local leaders were already chafing from what they saw as Bullock’s heavy hand.

“He has angered a lot of people in Flathead County,” County Commissioner Randy Brodehl, a Republican, said of Bullock. “He didn’t come here, he didn’t talk to us.”

Bullock’s troubles show that even if governors take measures to stem the spread of COVID-19, they may still have a difficult time persuading people to go along with them. That’s particularly an issue in the Upper Midwest and the Rocky Mountains, libertarian-leaning COVID hot spots where the medical infrastructure is already strained.

Some Trump supporters have followed the president’s lead in downplaying the virus and others are fatigued after months of isolation and precautions, said Whitlock.

In rural and conservative areas, people protest that COVID measures come at the expense of their personal freedom and their ability to earn a living, and some feel as though they’re being talked down to by mask advocates and public health officials, Whitlock said.

It’s going to take smart and consistent messaging to change attitudes — but that means more than Biden telling people to wear masks once he takes office, Whitlock added.

“Everybody has to own it,” he said. “You have to scream at the top of your lungs at the protests, at the celebrations, at the football games, at the concerts. It has to be, ‘Stop it!’”

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