As the legalization of healing psychedelic medicine progresses on the federal and state levels, the commodification has benefits along with several drawbacks.

Part of the tradeoff is that new synthetic drugs can be much more expensive and often deliver more targeted effects. However, classical psychedelics can be more holistic or intense. But they are not as respected or lucrative.

New research into psychedelic medicine is promising news to those with mental health conditions who can benefit in the coming years. 

But the question is who will have access? Will these naturally inexpensive, formerly illegal compounds be sold back to those who need them at prices only feasible for the wealthy?

This is occurring with magic mushrooms or psilocybin, DMT, along with Molly, Ecstasy, or MDMA.

Psychedelic Research Issues

The expenses of psychedelic research partially come from balancing regulations for Schedule I substances with complex research. The process demands strict compliance with the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) in every aspect. That includes participant selection, handling, project design, and ongoing informed consent.

To conduct clinical trials on Schedule I psychedelics, preclinical data must demonstrate that the product is reasonably safe before human trials begin. Companies must file an Investigational New Drug (IND) application with the FDA and a DEA Form 222, and get approved on both. The FDA recently released a legal psychedelic drug guide to help navigate the process.

The IND application needs at least 30 days of data, and must wait 30 days after filing. It is free. But applying for the drug to be approved after trials seems to be extremely costly. The DEA form 222 is free as well and also does not seem to take long. 

Having enough data to prove it is safe can vary in time, depending on the proof and whether it already exists from previous research. 

Some of the expenses come from balancing the regulations with the research. The process has to be done carefully to comply with regulations and the needed steps in research. 

The FDA drug research process is long. It includes multiple phases of trials, which might take years.

Big Pharma Giant Eli Lilly Acquiring Psychedelic Maker AtaiBeckley

The largest global pharmaceutical company, Eli Lilly, recently made a deal to acquire AtaiBeckley for $2.8 billion. 

This might accelerate research with Eli Lilly’s much larger resources. It is a step in how psychedelics are now being both seen and absorbed into the pharmaceutical space. 

Atai was the third psychedelic biotech to go public on the US stock market since it is traded on the Nasdaq. They followed the synthetic psilocybin biotech company Compass Pathways and what is now Definium Therapeutics. 

Palantir and PayPal cofounder Peter Thiel had backed Atai with an almost 70% stake in the company. 

The company’s leading product, BPL-003, is a synthetic 5-MeO-DMT that is inhaled through the nose. It is designed for rapid and durable treatment of Treatment-Resistant Depression (TRD). 

Their VLS-01 N-Dimethyltryptamine (DMT) film strip is being studied for TRD as well. Their EMP-01 R-MDMA capsule is in clinical trials for social anxiety disorder.

Legal Oregon Psilocybin Affordability Issues

An example of the great cost associated with healing via psychedelics can be seen in Oregon. 

In 2020, Oregon voters approved Measure 109 to establish a regulatory framework for legal psilocybin care. By 2023, they had opened their first psilocybin service centers where people can be treated. They have since treated and helped an estimated 22,000 clients. 

A psilocybin treatment session can already cost between $850 and $3,000. So it is skewing the clientele toward wealthier individuals. Between rent, plant medicine, therapeutic guides, and increasing fees, the industry is struggling. 

The program is funded by fees and is not integrated into hospitals or the general healthcare system. 

In June, the Oregon Health Authority proposed steep fee increases to sustain the program, including doubling the licensing fees for psilocybin manufacturing and service centers to $20,000. 

The Oregon Capital Chronicle reported that “the proposed changes would also eliminate reduced fees for nonprofits, veterans, and low-income people.” 

It’s a similar pattern to medical cannabis, which can naturally be grown by anyone. But in New Jersey, doing so is a felony. Instead, it is often sold to patients who need it at high prices. 

Synthetic Psilocybin Concerns in New Jersey

The shift toward synthetic versions of psychedelics was seen in recent New Jersey legislation as well. 

The developing NJ Psilocybin Behavioral Health Access and Therapy Pilot Program is supposed to allow for psilocybin trials in New Jersey. However, the NJ Psychedelic Therapy Association has raised concerns over the program’s insistence that only synthetic psilocybin be used. 

The benefit is that it will allow the active chemical to be researched alone. But the entourage effect allows patients to heal more from shrooms with natural chemicals.

Synthetic versions of shrooms, such as those made by COMP360, the most likely candidate for running the program, may be far more expensive for research and patients.

Natural Versus Synthetic Psychedelic Drugs

Natural healing substances like psilocybin have been used for centuries. In addition, clinical research into the healing abilities of psychedelics has been conducted since the 1950s.

Natural and synthetic psychedelics that can heal already exist. The success already taking place in Oregon with psilocybin could act as a model. But patient healing isn’t always as lucrative as pharmaceutical stocks in companies that can charge a premium price.

As long as profits decide where research and funding go, vital holistic aspects of ancient healing processes may be lost to advancing quarterly earnings and patentable drugs. 

Balancing Healing, Research, and Safety

Some companies actively heal patients. But natural psychedelics remain federally illegal and unfunded. So now new psychedelic-based synthetics that can be patented and sold for higher profits are being invested in by the billions. 

Research into new healing modalities is important for providing patients with the best options for care, and neuroplasticity can help to heal mental health conditions if guided correctly. 

However, whether they can all replicate the same depth of transformative and long-term positive psychological changes that a properly integrated psychedelic experience can have remains to be seen. 

As psychedelic medicine gains mainstream recognition, continued research into the most effective healing modalities is essential to support those who need care. However, patient accessibility and safety must be prioritized over profits or politics to follow the best interests of all patients.