Executive Order Boosting Access to Psychedelic Drugs for the Treatment of “Serious” Mental Illness Has Major Risks

Executive Order Driven Off‑Label Behavioral Health: Nothing to Measure, Now Reaching for Street Drugs

Republished with permission from AbleChild. 

Last week, President Trump announced, with great fanfare, through Executive Order (EO), that there would be increased federal participation in boosting access to current illegal psychedelic drugs for the treatment of “serious” mental illness. Everyone in the room thought it was a great idea, a miracle, but nobody that day, or since, has asked important questions that need to be answered, least of which is what the use of psychedelic drugs would do to children? We’ll get to that.

In the meantime, the push under the President’s EO is to slash the review time of these currently illegal chemical substances and, if safe and effective as “treatment,” get the drugs to those Americans in need as quickly as possible. The President couldn’t have a more enthusiastic partner than Health and Human Services Secretary Robert F. Kennedy, Jr., who has openly talked about his use of LSD and has long supported and been an outspoken advocate of increased research into psychedelic drugs as treatment for mental illness.

In fact, just days after the President announced his EO, Kennedy had already announced the first set of research teams and allotted funding up to $139 million to “spur new effective therapies for behavioral health.” The HHS Secretary’s new Evidence-Based Validation & Innovation for Rapid Therapeutics (EVIDENT) is “building the measurement science that can finally show what’s happening inside the body when someone is under treatment.”

That would certainly be a miracle but, of course, one cannot help but wonder how “the measurement science” will work when the psychiatric industry still is unable to identify any measurable abnormality that is any psychiatric diagnosis. No one in science has yet to pinpoint where in the brain the drugs would be targeted to “treat” the disorder. Currently the approved drugs will change behavior but certainly are not considered targeted “treatment.”

For example, President Trump mentioned the nation’s veterans who are suffering from Post Traumatic Stress Disorder (PTSD) as a group in need of better treatment. There is no doubt that many veterans have returned from combat with great mental injuries. No one doubts that the battle they have seen has inflicted horrific emotional scars but, contrary to what many believe, there is no measurable abnormality in the brain that is the PTSD diagnosis that can be identified and “treated” with drugs.

In fact, the pharmaceutical companies that produce the drugs that reportedly “treat” PTSD have no idea how the prescribed drugs “work” in the brain as “treatment” for any psychiatric disorder. Traumatic Brain Injury (TBI) (a physical brain injury), on the other hand, is a medical diagnosis and is “treated” by a neurologist, not a psychiatrist.

This isn’t new information. In fact, when Secretary Kennedy says that his new initiative, EVIDENT, is all about finding out how the new “treatments” are working, what is happening during treatment and who will respond to what treatment, there is no mention of identifying something to treat that can be measured.

For decades science has sought a measurable abnormality that is a mental illness and the National Institute of Mental Health (NIMH) has spent a fortune in taxpayer funds – more than $2 billion – trying to find any biomarkers that is any mental disorder. To date, those efforts have yielded zero mental disorder abnormalities that can be identified.

Further, one cannot help but wonder who decides what is “serious” mental illness? The President’s EO accelerates “Medical Treatments for Serious Mental Illness.” So, what constitutes “serious” mental illness compared to every day run of the mill mental illness?

Additionally, assuming researchers can overcome the enormous hurdle of having no identified abnormality to treat and given that hundreds of millions of dollars will be thrown at this initiative, one cannot help but wonder how a double-blind clinical trial would work with psychedelic compounds?

After all, let’s consider that MDMA “ecstasy” alters perception, Ibogaine creates vivid imagery and altered perception, Psilocybin or magic mushrooms cause distorted sights and sounds and LSD produces heightened sensitivity, panic, confusion and a wide range of mental states. The point of conducting double-blind studies is so that neither the participants nor the researchers know which “treatment” participants are receiving until the clinical trial is over, resulting in far less bias. Based on the immediate mind-altering effects of the above drugs it would appear that the participants would surely know they were given the drug and not a placebo (sugar pill).

And, equally important, one also might want to know how researchers will “measure with science” the success or failure of “treatment” without an actual physical abnormality to observe? Without that physical abnormality to measure, what is different or “new” about this initiative?

Finally, AbleChild is concerned about what effects these psychedelic drugs would have on children. Too many of the current mind-altering drugs are prescribed to children that have not been approved by the Food and Drug Administration (FDA) for use in children. It’s called off-label prescribing. A doctor may decide that a drug may help a child and although the drug has not been approved for children, the doctor can legally prescribe it – “off-label.”

It is interesting to point out, as a side note, that many of the veterans who may benefit from the possible approval of the psychedelics have been taking cocktails of psychiatric drugs that were not approved for use together. In other words, the pharmaceutical companies do not conduct joint clinical trials of each of the drugs together. The numerous drug cocktails prescribed have never undergone rigorous clinical trials to determine efficacy or safety.

Nevertheless, there clearly are many hurdles that must be overcome before these would-be miracle psychedelic drugs are approved as “treatment.” Currently, with no understanding by the pharmaceutical companies or the FDA, children also are prescribed cocktails of psychiatric drugs and in ever-increasing numbers.

Given the abuse of drug prescribing to children that the HHS Secretary is well aware of,  AbleChild would insist, up front, that protective federal policy assurances must be made before any possible approval of the psychedelics by the FDA.

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