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Husch Blackwell Authors Amicus Brief in Ninth Circuit’s Psilocybin Rescheduling Dispute

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Husch Blackwell prepared and filed an amicus curiae brief on behalf of nearly 30 end-of-life and palliative care clinicians, urging the U.S. Court of Appeals for the Ninth Circuit to compel the U.S. Drug Enforcement Agency (DEA) to initiate proceedings that could lead to a rescheduling of psilocybin for use in the end-of-life clinical setting.

The amici support the position of Seattle-based physician Sunil Aggarwal, who has been embroiled in long-running litigation with the DEA over the use of psilocybin. Following administrative law procedure, Dr. Aggarwal had asked the DEA to render an opinion on the use of psilocybin—currently a Schedule I drug—for palliative-care patients in light of the federal Right to Try (RTT) Act, passed in 2018, that allows certain patients access to investigational drugs outside of clinical trials. The Food & Drug Administration (FDA) defines Schedule I drugs as those “with no currently accepted medical use and a high potential for abuse.”

In the initial suit, the DEA refused to allow the use of psilocybin under RTT or otherwise condone its use outside of clinical trials, despite the fact that psilocybin has twice been designated by the FDA as a breakthrough therapy, arguably making it eligible for use under RTT laws.

Dr. Aggarwal’s initial efforts ended without a ruling on the merits of the case itself. The Ninth Circuit determined in January 2022 that it lacked jurisdiction to review the matter because the DEA had not yet issued a final agency decision. This ruling touched off a series of back-and-forth administrative law procedures that resulted in Dr. Aggarwal filing a citizen petition directed at the rescheduling of psilocybin itself, rather than the DEA’s regulatory posture toward psilocybin in light of the RTT Act. Dr. Aggarwal’s rescheduling petition was summarily rejected by the DEA in September 2022, leading to the current Ninth Circuit appeal.

In addition to the clinician signatories on the Husch Blackwell-authored brief, there are multiple groups supporting Dr. Aggarwal’s appeal, including medical researchers, professors of law, state legislators, and veterans’ affairs advocates. Additionally, policy institutes spanning the political spectrum, including the Goldwater Institute and the Cato Institute, have endorsed Dr. Aggarwal’s position in a bipartisan show of support.

Dr. Aggarwal and the Advanced Integrative Medical Science Institute—of which Dr. Aggarwal is a co-director—is represented by Shane Pennington of Vicente Sederberg LLP, Matthew C. Zorn of Yetter Coleman LLP, Kathryn L. Tucker of the National Psychedelics Association, and James F. Williams, Thomas J. Tobin, Andrew J. Kline, and Holly Martinez of Perkins Coie LLP.

“We are so grateful to see so many prominent hospice and palliative care clinicians support Petitioners in this important case,” said Tucker. “These clinicians know the suffering their patients endure with unrelieved anxiety and depression and are eager to add psilocybin-assisted therapy to the palliative care toolbox as soon as possible, because it brings immediate, substantial and sustained relief.”

“This case is, appropriately, centered on issues of administrative law, but the amici want to remind the court that there is so much more at stake,” said Husch Blackwell partner Karen Luong. “This is about basic human dignity, recognition of the medicinal use of psilocybin, and the right of dying patients to access valuable therapies that might help them in their last days. The DEA’s action has muzzled the most important voices in this fight—the doctors on the front lines and the patients themselves. We are honored to help these voices be heard.”

The Husch Blackwell team included Luong, Kimberly Chew, Natasha Sumner and Danny Solomon.



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Alert: We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

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Dear Interested Parties:

 

We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

 

This week, we wanted to share some logistical information about the application process.

 

We encourage you to submit your application online, and there will be instructions on how to submit applications on the Natural Medicine Division website.

However, based on stakeholder feedback, we will be opening up limited appointment slots for in-person assistance at our Lakewood office starting on Friday, Jan. 10, 2025. At this time, Fridays will be the only day that we will be offering in-person natural medicine licensing application assistance. We will be open from 9 a.m. to noon and 1 p.m. to 4 p.m. for in-person Friday appointments.

We are finalizing the applications and will be sharing those prior to our application process coming online. You can always check out our Public Resources folder to find information and compliance tools.

As always, please reach out to us at [email protected].us if you have any questions.

 

Stay tuned!

The Natural Medicine Division



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Mexican “Shamen” on The Run After Actress Dies In Frog Ceremony

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An actress in Mexico tragically lost her life after she ingested Amazonian frog venom as a part of a cleansing ritual while at a spiritual retreat. She experienced severe diarrhoea after taking part in the ceremony and was rushed to a hospital, but the doctors failed to save her life.

A shaman at the spiritual retreat where the actress took the Amazonian frog venom that caused her death has fled.
A shaman at the spiritual retreat where the actress took the Amazonian frog venom that caused her death has fled.

The 33-year-old actress Marcela Alcázar Rodríguez took part in the traditional South American Kambo ritual, which involves drinking water, getting burns on the body, and ingesting frog venom to cleanse the body of toxins, reported the Mirror. However, this ritual is known to have deadly consequences.

How is the Kambo ritual performed?

The participants in the ritual are made to drink more than a litre of water. Small burns are then created on their skin, following which frog mucus is applied on the wounds.

The mucus, which contains venom, increases blood pressure and induces vomiting, reported the outlet. It also causes diarrhoea in some cases. Other symptoms involve fainting, dizziness, swollen lips and face. Usually, the symptoms last for nearly half an hour. However, extended exposure of the venom to the blood stream can cause seizures and also death.

What happened to Marcela Alcázar Rodríguez?

Soon after beginning the ritual, Rodríguez reportedly started throwing up and eventually suffered from severe diarrhoea – these symptoms are often considered the body’s “healing” reactions during the cleansing process. Initially, she refused help but gave in when her friend visited her.

According to the Metro, a shaman at the retreat in Mayocoyani, Durango, told her she couldn’t leave. However, after her condition worsened, the person fled. Reportedly, police are now searching for the shaman.

Tribute to the actress

In a social media post, Durango Film Guild paid tribute to the actress after her untimely demise. They remembered her as “a young woman who worked in various short films, series and movies filmed in Durango.”

The guild added, “She leaves a void in the hearts of the people who knew her working in what she loved: cinema.”

 

https://www.hindustantimes.com/trending/actress-dies-after-taking-amazonian-frog-venom-during-cleansing-ritual-at-spiritual-retreat-101733371832107.html?ck_subscriber_id=1050193520



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Dutch police find gnome made of MDMA during drug bust

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Officers in the southern Netherlands have found a garden gnome weighing nearly 2kg (4lb) and made of the drug MDMA.

“Drugs appear in many shapes and sizes, but every now and then we come across special things,” Dongemond Police said in a translated social media post.

The gnome was found among suspected narcotics during a large drug search.

“In itself a strange place to keep your garden gnome,” the force said. “That’s why we decided to test [it] for narcotics”.

“The gnome himself was visibly startled,” police said, referring to the gnome having its hands covering its mouth.

It is not known which area the gnome was recovered in, but the Dongemond Police covers the municipalities of Oosterhout, Geertruidenberg, Drimmelen and Altena.

MDMA – which is an illegal substance in the Netherlands – is a synthetic party drug also known as ecstasy.

As of 2019, the Netherlands was among the world’s leading producers of MDMA.



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