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Doctor Continues Challenging the DEA for RTT for Psilocybin Access

Terminal patients have been allowed to try experimental drugs for years under Right To Try laws. Psilocybin, however, has remained inaccessible despite tons of evidence supporting its benefits, and Dr. Sunil Aggarwal has had enough.

The Right To Try

Right to Try (RTT) is one option for patients with life-threatening diseases or conditions who have exhausted all approved treatment options and are unable to participate in a clinical trial to gain access to drugs not approved by the FDA. This provision allows patients and their doctors to work with a company developing a drug or biologic to request access without involving the FDA. Currently, 41 US states have RTT provisions. Former President Donald J. Trump even signed the ‘Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act’ in 2018, making RTT laws federal.

 

Right to Try (RTT) is one option for patients

 

Magic Mushrooms And The Right To Try

RTT laws allow patients to access drugs that have completed phase 1 clinical testing – unfortunately, because many therapeutic drugs like cannabis and psilocybin are Schedule I substances, researchers have been largely unable to move forward with research.

Several patients have tried to access psychedelics under RTT laws but have been prevented at almost every turn. Erinn Baldeschwiler, a terminal breast cancer patient from North Bend, WA, has been pleading with the Drug Enforcement Administration to allow her access to psilocybin to help alleviate her depression and anxiety. According to the agency’s response, Right to Try does not allow for an exemption to the Controlled Substances Act, which restricts access to certain drugs. An appeal was filed by Baldeschwiler and her supporters, but it was denied. The Ninth Circuit Court ruled that the DEA’s response was “guidance,” not a ruling. The court also pointed out that Congress has not made an exception to the Controlled Substances Act to allow for the legal use of psilocybin.

Dr. Sunil Aggarwal’s Fight For Shrooms

Dr. Sunil Aggarwal, a palliative care specialist, has also been putting pressure on the DEA. Aggarwal is fighting for his patients’ legal access to psilocybin, as well as the rescheduling of the drug and the implementation of federal Right To Try (RTT) laws.

The clinician, backed by Senators Cory Booker (D-NJ) and Rand Paul (R-KY), plus Representatives Earl Blumenauer (D-OR) and Nancy Mace (R-SC), insists that RTT laws allow seriously ill people to receive medical treatment with investigational drugs no matter their scheduling.

The DEA rejected Dr. Aggarwal’s petition last month, stating that psilocybin is a Schedule I drug. They also implied that those behind the appeal were motivated by commercial interests. Coming from a US Federal Agency, this is extremely ironic.

Dr. Aggarwal and his attorneys have responded by filing a new challenge to the rescheduling petition denial in the United States Court of Appeals for the Ninth Circuit, with opening briefs due on January 9 (petitioners) and February 7 (respondents) next year.

 

Dr. Sunil Aggarwal’s Fight Shrooms

 

Does The DEA Know What They’re Doing?

Clearly, the answer to this is no. Anyone who thinks weed is more dangerous than bath salts is smoking something, and the DEA is making no effort to reschedule anything. Another thing the DEA doesn’t understand is that psilocybin has actually already passed Phase 1 clinical trials – in fact, Compass Pathways is gearing up for Phase 3. According to the literal FDA, anything that’s completed a Phase 1 trial is acceptable under RTT, so the DEA is blatantly standing in the way of healthcare.

 


 

It’s common belief that government agencies are run by idiots, but it’s seriously impressive how dedicated they are to denying terminal patients some sort of respite. It is our responsibility to do everything we can to make terminally ill patients as comfortable as possible for as long as possible, and allowing them access to experimental drugs is part of that. Plus, if you’re dying, why can’t you do a few drugs?

RTT laws already exist. Doctors are on board, patients are ready, and researchers are working hard. All that’s left is for the DEA to play catch up and get with the times.

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