Dying Americans Have the Right to Psilocybin Therapy Now!


Sign Our Petition to the Administrator of the Drug Enforcement Administration!

Dear Anne Melissa Milgram,

I am writing to you, the Administrator of the Drug Enforcement Administration (DEA), to voice concern about your agency obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws. Research demonstrates that psilocybin provides immediate, substantial, and sustained relief from debilitating anxiety and depression in individuals with terminal illnesses. I strongly believe that people in my community suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment.

Individuals with advanced cancer that are also suffering from treatment-resistant anxiety and/or depression have been found to experience significant reductions in both anxiety and depression, and improvements in mood, following a single guided session of psilocybin-assisted therapy, with no safety concerns or clinically significant adverse effects. Of note, researchers have also found that the benefits from such a treatment are sustained, with patients experiencing increases in measures of quality of life, life meaning, death acceptance, and optimism six months after treatment. I am excited by this research and the implications it has for members of my community suffering terminal illness.

Recognizing that people with terminal conditions do not have the luxury of time to await the slow approval process for new drugs, in 2018 federal lawmakers enacted the Right to Try Act, echoing 41 similar State legislative enactments, to ensure that these individuals have access to drugs in investigational stages. RTT statues allow for terminally ill individuals to access drugs still in investigational stages. Psilocybin qualifies as an investigational drug under the terms outlined in applicable state and federal statutes. Notwithstanding, suffering dying individuals seeking treatment with psilocybin are being prohibited from receiving such a treatment because of the DEA’s refusal to accommodate RTT. This has led the Advanced Integrative Medical Science Institute (AIMS), an outpatient oncology clinic and research institute that has been denied access to psilocybin for therapeutic use with terminally ill individuals, to file suit against the DEA (AIMS, et al v. USDEA). This case can and ought to be quickly settled in a manner which addresses DEA’s legitimate concerns about ensuring adequate security to prevent diversion, while enabling dying cancer patients such as those in the AIMS case access to psilocybin, as intended by RTT laws. Urgent action is needed to ensure that people currently suffering terminal illness can elect treatment involving psilocybin.

I therefore urge you to take quick action to ensure that the DEA follows duly enacted RTT law and accommodates people in my community with terminal illnesses in receiving psilocybin for therapeutic use. I appreciate your attention to this urgent matter.

%%your signature%%

87 signatures = 9% of goal
0
1,000

Share this with your friends:

   


On May 9, 2022, we demonstrated for nearly 4 hours outside of the DEA HQ, which resulted in 17 arrests for trespassing. We are planning future demonstrations, so please sign up below to get involved!

For those unable to join us in person, here’s the livestream:

Click here to watch the live stream on Facebook


This 5 minute film was produced by reconsider:

Click here to watch “Right to Try Psilocybin: Demonstration at DEA HQ (May 9, 2022)” on Vimeo


This 4 minute film was produced by Susan Rockefeller:

Click here to watch “DEA: Stop Blocking Terminally Ill Patients From Legally Accessing Psilocyin Therapy” on Facebook


PRESS:


Share this graphic on your social media channels!

Please sign up below to get involved in our efforts!


This Call to Action was published on April 13:

Join us for a

National Mobilization and Call for Civil Disobedience on Behalf of Terminally Ill and Others Facing Life-Threatening Conditions

May 9th @ Noon

DEA HQ
700 Army Navy Dr., Arlington, VA 22202

DEA GET OUT OF THE WAY!

Psilocybin therapy has shown incredible promise alleviating the debilitating existential distress many terminally ill Americans face in their last days, sabotaging their quality of life and time with family and friends. FDA has granted “breakthrough status” to psilocybin therapy for depression, in light of safety and promising signs of efficacy in stage 2 FDA trials, especially for end of life patents. Congress passed the national Right to Try Act in 2018 to allow Americans with life-threatening conditions to access promising medicines that have passed phase I trials, without having to wait for completion of the new drug approval process.. However DEA is blocking access to psilocybin therapy, even as Canada is now allowing north of the border.  Kathryn Tucker, lead litigator in the Right to Try litigation seeking to overcome DEA obstruction and provide access for dying patients sums it up:

“To absolutely prohibit access, when state and federal law are intended to allow access, that is impermissible. …These dying patients could have immediate, substantial, and sustained relief from debilitating anxiety and depression. That’s what all the studies show.. Why anyone would obstruct access to that kind of relief for a dying patient is impossible to comprehend.”

At noon on May 9th, 2022, patients, veterans, and other advocates will gather with family and friends in front of DEA headquarters, to protest and engage in civil disobedience, blocking DEA entrances to demand the agency stop its obstruction of duly enacted state and federal laws, and open access to this healing therapy for end-of-life suffering.


Please donate to cover travel costs of end of life advocates as well as family and friends of the terminally ill who want to protest!


Short Timeline Revealing DEA’s Delay and Obstruction

January 2021: Physician and Patients request for access to psilocybin presented to DEA
February 2021: DEA denies any access for therapeutic use
March 2021: Federal court challenge to DEA position filed on behalf of physician and patients. Case is knowns as AIMS et al v DEA, filed in the Ninth Circuit Court of Appeals.
April-August 2021: Legal briefs filed with court, including a multitude of Friend of the Court briefs by those supporting Petitioners:
• Eight States and DC
• Cato and Goldwater Institutes
• The ACLU
• End of Life Advocates, leading researchers, leading palliative care experts
September 2021: Oral argument heard by the Ninth Circuit
January 18, 2022: a bipartisan delegation of Members of Congress submit letter to DEA urging access and compliance with RTT laws
January 31, 2022: Ninth Circuit issues opinion finding DEA action not “final” for purposes to enable judicial review.
February 2, 2022: Petitioners submit a Petition to Reschedule Psilocybin from Schedule I to Schedule II
February 10, 2022: Petitioners submit a Request for Waiver to enable access to psilocybin pursuant to state and federal RTT laws, seeking an agency action sufficiently “final” to enable judicial review. DEA has yet to even formally acknowledge receipt, and clearly intends to do everything in their power to continue to deny and delay.
March 31, 2022: Petitioners submit a Freedom of Information Act request to DEA, demanding information on it handling of the Request for Waiver and Petition to Reschedule.
April 13, 2022: Letter mailed to DEA asking why it takes so long to accept a petition for rescheduling
May 9, 2022: Activists gather outside the DEA HQ to STOP THE DEA DELAY!


FOR IMMEDIATE RELEASE
Monday, May 9, 2022

CONTACT: Adam Eidinger
Press@RightToTryPsilocybin.com | 202-744-2671

Terminally Ill Cancer Patient and Supporters of the Right to Try Act to Shut Down Drug Enforcement Administration Headquarters

The DEA Is Preventing Terminally-Ill Patients Their Legal Right to Try Psilocybin by Invoking the Controlled Substances Act

ARLINGTON, VA — On Monday, May, 9, at 12:00pm ET, supporters of U.S. citizens’ right to try psilocybin will hold a rally and engage in nonviolent civil disobedience at the Drug Enforcement Administration (DEA) headquarters. Passed by Congress and signed by President Trump in 2018, the Right to Try Act affords citizens with life-threatening conditions the right to use experimental drugs as long as the drug has completed Phase 1 clinical trials and remains under investigation. Laboratory-produced psilocybin, the psychoactive chemical commonly found in psilocybe mushrooms, has completed Phase 1 and Phase 2 trials, remains under investigation, and has been designated as a “breakthrough therapy” by the Federal Drug Administration. Psilocybin has been shown to bring ‘Immediate, substantial and sustained’ relief from anxiety and depression in dying patients. Unfortunately, the DEA has prevented terminally-ill patients from receiving the drug for nearly two years by incorrectly citing the Controlled Substances Act and psilocybin’s status as a Schedule I drug.

“My cancer is progressing and I am running out of time to access this promising medicine. It is not just the DEA’s refusal to grant access, but the fact that they have yet to confirm receipt and/or respond to our waiver request from early February is inhumane, unjust, and downright shameful. This agency is not above the law, and in this instance a law that was passed with overwhelming unilateral support from our legislators.” says Erinn Baldeschwiler, a mother of two teenagers, who was diagnosed with Stage 4 metastatic breast cancer in 2020.

Ms. Baldeschwiler’s doctor, Dr. Sunil Aggarwal, a Seattle palliative care physician and co-director of the Advanced Integrative Medical Science Institute, sought permission from the DEA to obtain psilocybin for his patients. As a Schedule I substance, this requires the DEA to sign off on his request, which it has refused to do. This began a legal battle that is still ongoing.

“We have patiently explored every avenue with DEA to gain its approval for terminally ill patients to access psilocybin for relief of debilitating anxiety and depression. Access is intended by duly enacted state and federal Right to Try (RTT) laws. Yet the DEA has engaged in delay and obstruction. This is unacceptable. My clients are running out of time. There is urgent need for the DEA to accommodate RTT and enable access. This demonstration shines the bright light of public concern and outrage on this agency’s conduct. Not one more day ought to go by without the DEA creating a path to access.” says Kathryn Tucker, Special Counsel with the Emerge Law Group and the Lead Counsel in the legal battle for the doctors and patients.

As their lawsuit has moved through the courts numerous members of Congress and Attorneys General have reached out to the DEA and submitted amicus briefs (See Timeline below). All appeals have fallen on deaf ears and have given reason for advocates to come to the DEA Headquarters to demand action.

“Psilocybin therapy has the power to help patients in the final months of their life, to break through fear and anxiety, and enjoy their family and loved ones” says David Bronner, the Cosmic Engagement Officer of Dr. Bronner’s, the nation’s leading organic and fair trade soap company, which has supported efforts to ease restrictions on psilocybin. “DEA is way out of line denying Americans access to this kind of relief in their last days.” Bronner will be speaking at the rally and engaging in nonviolent civil disobedience in support of the patients.

# # #