The Drug Enforcement Administration (DEA) may soon have to defend itself in federal court again after denying access to psilocybin to Washington State physician Sunil Aggarwal of the Advanced Integrative Medical Science (AIMS). Aggarwal had requested the substance on behalf of his terminally ill patients under the “Right-to-Try” (RTT) laws.
More than a year has passed since Aggarwal requested permission from the DEA to administer psilocybin to treat the severe depression and anxiety plaguing his cancer patients. The abrupt denial has since led to a court challenge, with plaintiffs citing the fact that the agency is not following true RTT protocols. The extended timeline already presents a significant problem in and of itself, considering what we know about the psychological makeup of terminally ill patients. The other issue lies with the specifics of the RTT laws, which we will elaborate upon below.
Succinctly broken down by the US Food and Drug Administration (FDA), “the Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.” The FDA goes on to classify “eligible patients” as individuals who have been diagnosed with a life-threatening condition or disease. To our knowledge, this is exactly what cancer is. It also goes on to stipulate that these specific individuals should have exhausted all other traditional options and that their use of investigational drugs must be certified by a doctor in good standing with their licensing board. We see no reason why a Washington State physician of AIMS does not present the ideal candidate here.
It ends by saying that the patients in question should provide written formal consent for their doctor’s approval to get the ball rolling. Aggarwal has followed all the necessary steps and instead of facing administrative red tape, he is now faced with bureaucratic red tape. The latter should not even be a concern, considering the fact that the FDA has so clearly outlined the terms of the RTT Act. At face value, this appears to be a clearcut win for the terminally ill patients who requested the use of psilocybin to provide a temporary reprieve from their pain and suffering. However, a year has already passed, and the court date has yet to be set.
Let Them Use Psilocybin
As far back as January, bipartisan members of Congress have gotten involved in gaining access to the use of psilocybin for terminally ill patients. Rep. Earl Blumenauer (D-OR) has been of the most vocal among them, seeking to gain legal access without fear of federal prosecution. Having started a Dear Colleague letter that gained significant momentum and garnered support from both sides of the aisle, it was summarily shot down by the DEA, which resulted in the lawsuit being filed.
The coalition of lawmakers who signed the letter reportedly stated that the DEA is “obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.” This accusation appears accurate, given the extent of the RTT Act as outlined by the very body responsible for these decisions, the FDA. This then brings into question the perceived authority the DEA thinks it possesses to deny access from a respected source for legitimate reasons.
At this point, we can rest assured knowing that Aggarwal will win the fight on behalf of the patients in his care. However, there are numerous factors to consider. Having already waited a year to receive a response, how much longer will this be dragged out until he is given access? Once granted access, will it be on specific terms and would he have to reapply at some point? What about other physicians in a similar position? Has Aggarwal set a precedent that will make their application process smoother or will this just be another way for the DEA to obstruct the goal they are trying to achieve? The decision-makers at the DEA may learn something from the Hippocratic Oath all doctors must take; “first, do no harm.” Only then will we be able to find a clear way forward.
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