Psychedelic Medicine: The Legal Disconnect Grows

• Laws concerning psychedelic drugs in most jurisdictions are both perverse and fraudulent
• Lack of access to psychedelic medicine is resulting in ~8 million preventable deaths per year
• Our drug laws are literally killing people as ivory-tower governments look the other way

Psychedelic drugs are (safe) Miracle Drugs that can apparently revolutionize the treatment of mental health disorders for the roughly two billion people globally with a treatable mental health disorder.

Psychedelic drugs are illegal narcotics that have no accepted medical use and present a high potential for abuse.

One of those statements is a fact. One of those statements is the law.

Absolutely contradictory.

In fact, yet another formal clinical trial testing the efficacy of a psychedelic drug-based therapy is wrapping up. This one is a Phase II clinical trial sponsored by NYU Langone Health, evaluating the efficacy of a psilocybin-based therapy to treat alcohol use disorder.

It will likely be several months before the trial’s results are published. However, if the trial is able to duplicate the results of a 2015 study from the University of New Mexico, we can expect some promising numbers.

In that study:
 
Yes, significant treatment gains that were largely retained after 9 months with no adverse treatment “events” certainly warrants further clinical study.

Psychedelic drugs are revolutionary medicines for substance abuse/addiction

Globally, an estimated 107 million people are afflicted with alcohol use disorder. Existing treatment programs have mixed success in addressing the symptoms of this form of substance abuse (and others), but offer no cures. The addiction itself is untreated.

In contrast, psychedelic medicine is all about delivering actual cures for mental health disorders such as substance abuse/addiction, not just medicinal or therapeutic crutches.

Positive results in treating alcohol use disorder should come as no surprise to those familiar with medicinal applications for psilocybin. A 2014 clinical study by Johns Hopkins University using psilocybin-based therapy to treat nicotine addiction reported that 80% of participants were still fully abstinent 6 months later.

That efficacy rate is more than double that of the best existing “smoking cessation” product on the market today.

Researchers have been slower in exploring the potential of psilocybin as a treatment for opioid abuse disorder. However, a 2017 study found that “preliminary” research indicates that substances like psilocybin and LSD “are potentially effective and durable substance misuse interventions.”

In fact, even the illicit use of these “psychedelic drugs is associated with decreased risk of opioid abuse and dependence.” Psychedelics such as psilocybin and LSD appear to have inherent anti-addiction properties.

A growing body of research is indicating that ibogaine, another psychedelic, can be potentially even more effective in treating opioid abuse. However, ibogaine-based therapy presents somewhat greater safety/tolerance concerns.

In the United States alone, over 90,000 people died from drug overdoses in 2020 (most related to opioids). That’s a 30% year-over-year increase in what has already been identified as an addiction crisis – a crisis that conventional medicine has been impotent in treating.

Legalizing psychedelic medicine to treat addiction has the potential to save a lot of lives in a short period of time.

Psychedelic drugs are revolutionary medicines for depression

Psychedelic drugs (such as psilocybin) are also revolutionary medicinal therapies for the treatment of depression. This applies to different categories of depression, such as Treatment-Resistant Depression (TRD) and Major Depressive Disorder.

Compass Pathways (US:CMPS) is currently wrapping up a Phase IIb clinical trial using psilocybin-based therapy to treat TRD. The FDA has granted Breakthrough Therapy Designation to expedite this research – for two reasons.
 

1. Previous psilocybin-based research for TRD has already shown enormous potential
2. Conventional medicine has again been impotent in providing relief for sufferers

A 2016 study on a psilocybin-based therapy for TRD reported that 66% of patients were in remission after their first psilocybin therapy session.

Cybin Inc. (US:CYBN / CAN:CYBN) is preparing to launch a Phase IIa clinical trial using a psilocybin-based therapy to treat MDD.

Psychedelic drugs are also demonstrating efficacy in treating depression among different categories of depression patients: cancer-related depression, concussion-related depression, end-of-life related depression, etc. Health Canada has already been granting special “exemptions” to allow psilocybin-based therapy to treat the depression of terminal patients.

In contrast, 50% of Americans being treated for depression with conventional “first-line drugs” reported no benefit. Of those who did obtain some benefit, roughly 1/3rd of that is merely a placebo effect.

Terrible efficacy. As a result, U.S. depression sufferers frequently remain in treatment for many years (if not permanently), often becoming addicted to these minimally effective antidepressants along the way.

They seek a cure for one mental health disorder but end up with two. Consequently, two out of three Americans exhibiting symptoms of depression don’t even seek treatment.

“Treatment-resistant depression” is just a medical euphemism for failure. Simple bacterial infections were “treatment resistant” before the introduction of penicillin and other antibiotics, the first Miracle Drugs.

Depression in the United States is largely untreated. But depression is also a killer – a major killer.

Globally, there are an estimated 800,000 deaths by suicide each year. In the United States, a “suicide epidemic” is now in its eighth year – and continues to worsen. Today, one American commits suicide (on average) about every 10 minutes.

Legalizing psychedelic medicines to treat depression has the potential to save a lot of lives in a short period of time.

Psychedelic drugs are revolutionary medicines for PTSD

Post-Traumatic Stress Disorder (PTSD) is a particularly debilitating (and deadly) mental health disorder. It’s also an epidemic -- among past and present U.S. military personnel -- afflicting 10s of thousands of veterans who have seen combat duty in the U.S. military.

It’s another largely untreated mental health crisis. Approximately two out of three veterans attempting to get their PTSD treated by the Department of Veterans Affairs report no benefit from their therapy.

The failure of the U.S. government to “support the troops” through providing even adequate mental health therapy is having devastating consequences.

An average of 22 U.S. veterans commit suicide each day. And once again, we already know that psychedelic medicines could be saving many (most?) of these lives.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of completing a Phase III clinical trial using MDMA-assisted therapy to treat PTSD.

Results released to date have been nothing short of outstanding. Approximately 90% of participants reported some benefit with 67% “no longer qualifying” for a diagnosis of PTSD. Cured.

Preliminary research also indicates that psilocybin-based therapy could be very effective as an additional treatment for PTSD. Mydecine Innovations Group (CAN:MYCO / US:MYCOF) is preparing to launch a Phase IIa clinical trial here.

Legalizing psychedelic medicines to treat PTSD has the potential to save a lot of lives in a short period of time.

Legally, in the United States psychedelic drugs have “no currently accepted medical use”

No currently accepted medical use.

That is the part of the definition of a Schedule 1 narcotic. It is the official stance of the United States federal government toward all of these psychedelic drugs (except ketamine).

Why are these extremely potent medicines still in clinical trials rather than already saving lives and reversing a worldwide Mental Health Crisis that now totals two billion treatable mental health disorders?

Because they are all still officially illegal, in the United States and most of the world’s other medically-backward regimes. All part of a 50-year “War on Drugs” that has now been universally proclaimed as a colossal failure – by almost everyone except its perpetrators.

Is curing mental health disorders not “an accepted medical use”? Is saving lives not “an accepted medical use”?

Perhaps the members of Congress have never heard of Johns Hopkins University or the other reputable medical institutions that are regularly demonstrating “accepted medical uses” for these psychedelic drugs? Most people do know the name “Johns Hopkins”.

Perhaps the members of Congress have never heard of the U.S. (federal) Food and Drug Administration? The FDA is now regularly granting permission for new psychedelic drug clinical trials at Phase II or later.

A Phase II clinical trial is not to test if the psychedelic drug in question has “an accepted medical use”. It’s to test how effective a particular, known medical use actually is. Proof of concept.

U.S. federal laws on psychedelic drugs (as well as the laws of most other nations) are not merely “wrong” with respect to psychedelic drugs. They are perverse.

The opposite of reality. A legal fraud, in every respect.

Large numbers of people are needlessly dying in the United States (and all around the world) every day because governments won’t reform their fraudulent drug laws. This is despite widespread urging (all the way up to the United Nations) to begin immediately decriminalizing these substances.

Schedule 1 drugs are also deemed to have “a high potential for abuse”. Really?

Most psychedelic drugs are both non-toxic and non-addictive. No one dies. No one gets ‘hooked’. Where is this so-called “high potential for abuse”?

In contrast, both alcohol and nicotine are highly addictive and very toxic. Vast numbers addicted to both. Neither has any accepted medical use.

Globally, over 7 million people die each year from nicotine and alcohol abuse. That’s what real “Schedule 1” drugs look like.

The deadly and addictive poisons are legal. The medicines that could protect people from these deadly/addictive poisons are illegal. More legal perversion.

Ignorance is curable, stupidity is terminal

Ignorance is simply a state of not knowing.

It is an easily treatable condition. Except instead of medicine, the “treatment” is education. Curing ignorance through no longer being ignorant.

Stupidity, conversely, is a terminal condition.

Stupidity is the conscious choice to wallow in one’s ignorance. It is a refusal to learn. A “closed” mind.

Congress has recently and literally illustrated its own stupidity toward psychedelic drugs – with an exclamation point.

A proposed recent amendment that would merely allow the federal government to study psychedelic medicine was voted down 331-91.

Out of 422 Congressional members, 331 voted to continue to wallow in their own ignorance.

Voting to merely study psychedelic drugs doesn’t commit the federal government to legalize psychedelics any more than studying accounting forces one to become an accountant.

People study accounting to put them in a better position to evaluate that occupation. Studying psychedelics would put the federal government in a much better position to evaluate the potential of psychedelic medicine.

Instead, by a wide majority, Congress chose stupidity.

Stupidity is terminal. It’s killing one American every 10 minutes via suicide. It’s killing one American every five minutes via drug overdose.

Every day, Congressional stupidity is killing 22 of the veterans who risked their lives to serve their country.

Every year, Congressional stupidity is killing ~500,000 Americans due to long-term nicotine addiction.

That’s quite a body-count simply because Congress is choosing to remain ignorant regarding the potential of psychedelic medicine to save American lives.

Too old to govern?

Rightly or wrongly, a common stereotype is that many older people get ‘stupid’. The perception is that people reach a certain age and their mind (literally) closes. They become incapable of learning.

You can’t teach an old dog new tricks.

Is age the root cause of Congressional stupidity toward the potential of psychedelic medicine? Today, the average age of Congress is 59. The median age is 60 (half of Congress is 60 or older).

Psychedelic medicine has the clear potential to reverse a Mental Health Crisis that (on multiple fronts) is ravaging all demographics of U.S. society and leading to one death roughly every 3 minutes from suicides and drug overdoses alone.

What does the U.S. government have to lose from merely studying this potential? Is Congress simply (collectively) too old to provide responsible government for Americans?

Term limits are a common feature of most political systems. As our societies steadily age, is it time for us to seek age limits for our political representatives?

Just because someone isn’t likely to die while in office doesn’t mean they are fit to govern. The light bulb may be on, but that doesn’t mean that there is anyone at home.

Bipartisan stupidity

If it’s not the age of House and Senate members that is preventing the U.S. federal government from engaging in critically-needed drug reform, is it the age of its political parties?

The failure to do anything at all about a U.S. suicide epidemic that is rapidly worsening and is now in its eighth year is a bipartisan effort. Democrats and Republicans alike have chosen to remain ignorant about this crisis.

The failure to anything at all about a U.S. PTSD epidemic that is killing 22 veterans per day is a bipartisan effort.

The failure to do anything at all about a U.S. drug overdose epidemic that is rapidly worsening and killing one American every 5 minutes is a bipartisan effort.

Perhaps it is the U.S.’s two main political parties that have simply gotten too old to learn?

Power corrupts. Absolute power corrupts absolutely.

In the U.S.’s two-party political system (with its “checks and balances”), neither of these parties has ever been fully removed from power in nearly 250 years.

That’s a long time for political parties to be going rancid with corruption.

You can’t teach an old dog new tricks.

The problem is that with multiple crises confronting Americans today, including several different mental health crises, the United States is in desperate need of some “new tricks” – starting with access to psychedelic medicine.

Psychedelic drugs and the emerging psychedelic drug industry are a fantastic long-term commercial/investment opportunity. But psychedelic medicine is more than that.

It is the focal point of a healthcare Revolution in treating mental health. With 2 billion treatable – but generally untreated -- mental health disorders in the world today and 8 million preventable deaths per year, it is our #1 healthcare priority.

The legal disconnect with psychedelic medicine must end. It’s time for the law to follow the science regarding psychedelic drugs instead of blocking it.