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Doctor sues DEA to treat terminally ill patients with psilocybin

Doctor sues DEA to treat terminally ill patients with psilocybin

Dr. Sunil Aggarwal and the clinic he co-founded, Advanced Integrative Medical Science Institute, or AIMS is suing the Drug Enforcement Administration (DEA) for refusing to let him treat terminally ill patients with psilocybin. Dr. Aggarwal wanted to treat patients at the end of their lives under Washington state’s “Right-to-Try” law to use unapproved, investigational drugs for therapeutic use.

The doctor claimed in his court brief that he had asked the DEA numerous times to allow him to treat the patients, but was refused each time without a response. Psilocybin is a Schedule I drug under the Controlled Substances Act. One of the main descriptors of this class is that the drug has no medicinal qualities. However, the court brief states that psilocybin has twice obtained “breakthrough therapy status” from the Food and Drug Administration (“FDA”) and is in stage III clinical trials.

“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT, it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent,” the brief said. The doctor holds a DEA license to prescribe schedule II–V drugs.

The brief notes that Dr. Aggarwal first argued that he should be allowed to use the drug because of the RTT laws without a special permit, and was denied. He then asked the DEA to let him use it with a special waiver and highlighted other instances where the DEA has granted waivers. He was still denied despite citing other examples of DEA waivers like therapeutic use of cannabis for children. The doctor believes the DEA must provide a reasoned explanation for how that decision comports with the CSA and the agency’s precedent.

Terminally ill patients
Dr. Aggarwal treats patients with advanced-stage cancer, including some suffering from severe and debilitating anxiety and depression that do not respond to FDA-approved therapies. Based on his professional experience and assessment of his patients, Dr. Aggarwal discussed the possibility of psilocybin therapy, including the risks and rewards, with select patients. He said these patients indicated a desire to try psilocybin treatment and gave informed consent.

Kathryn L. Tucker of the National Psychedelics Association, one of the attorneys representing Aggarwal and AIMS, told Law360 on Friday that the protracted legal wrangling caused by the DEA’s denials had obstructed dying patients’ access to a drug that their doctors believed would give them relief from anxiety and depression.

“Right to Try is intended to allow dying patients access to promising investigational drugs recognizing they do not have time to wait for the slow process of new drug approval to wend to completion,” Tucker said.

Long battle
The doctor has been fighting with the DEA for a couple of years over his desire to try psilocybin with dying patients. However, according to the brief, the DEA in 2022 did state that offering the drug to terminally ill patients wouldn’t be consistent with public health and safety.

The doctor also claims in his brief that the DEA instead wanted him to register as a researcher in order to obtain the drugs for his patients. Dr. Aggarwal says this would force him to create a study protocol and submit it to the FDA for approval, which goes against the RTT law.

Law360 also noted that in a related case, a Ninth Circuit panel in October ordered the DEA to clarify why it believes psilocybin should remain a Schedule I substance after the agency cursorily rejected Aggarwal’s petition to move psilocybin to Schedule II — the tier for drugs that have a currently accepted medical use with severe restrictions.

1796000-1796517-aims brief 2.08.24

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