Psychedelic Momentum
We’re in the very early stages of the role of psychedelics in treating severe mental illness. There’s essentially no coverage formally outside of a nasal spray called Spravato for treatment resistant depression but two recent developments could mean changes are coming over the next 3 years:
The federal government’s new policy seeking to accelerate psychedelic research, particularly the timing of review should phase 3 clinical trial results show positive outcomes
Pharmaceutical companies are beginning to look at acquiring businesses, as Eli Lilly has done in acquiring AtaiBeckley, a business developing psychedelic treatments
Most of us see Jenny from Forest Gump when we hear about psychedelics - her tragic reliance on them amidst the Vietnam war opposition, in part dealing with an abusive childhood, all in sharp contrast to Forest’s straight down the fairway rule following life.
The two developments are promising but they do not validate that the medicines work. They merely confirm government wants development to move more quickly in getting safe treatments to market, and that the pharmaceutical industry sees major business opportunity.
Talking with psychiatrists, hospitals, frontline crisis center staff and those in social services across the US, there’s very clearly a need for better treatment and solutions for PTSD, severe mental illness and major depression. But there are barriers around psychedelics as they come up the checks and balances of clinical trials:
Evidence remains low about their overall efficacy and perhaps moreso safety, such that policymakers and insurers still consider them ineffective—even dangerous
Medical societies, physicians, employers and insurers charged with paying for these would like more trained clinicians and controlled settings; this request sounds familiar to the calls for having clinicians better trained in handling suicide
Tapering is a common part of the drug treatment protocol in behavioral health care but tapering psychedelics is not so simple given withdrawal symptoms, suicidality risk.
Plus, several researchers told us it’s difficult to do blinded trials because the person who gets the treatment will know they’re on the actual medicine given the likely response, and so too may the therapist.
Psychiatrists who are helping the nation’s largest insurers to design medical coverage policy are just waiting. “We need to know what we’re approving. Is it a drug and psychotherapy, a clinical service with monitoring.”
Some are worried if the clinical trial safety oversight could be reproduced by clinics. And, if the answer is yes, what is the cost of that oversight and incremental benefit. Saying that, if there is a way to have these medicines integrated for the right population, these treatments could open the door for better quality of life without the need for hospitalization or institutionalization.
The FDA has not approved a treatment called MDMA that is designed to help address PTSD. A spokesman said the agency had questions about safety.