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Right to Try, Try, Try Again
The Right to Try Clarification Act
Today we’re following up on last week’s dispatch on the prospect of psilocybin access for patients with life-threatening conditions through the federal Right to Try (RTT) Act.
This week, Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced The Right to Try Clarification Act.
From the press release(emphasis added):
“Specifically, the Right to Try Clarification Act would remove any obstacle presented by the Controlled Substances Act with respect to Schedule I substances when they are used by doctors and patients in accordance with the federal Right to Try law…
If it is passed it would codify into law that Schedule I substances, such as MDMA and Psilocybin, which have passed Phase I FDA trials are permissible under the Federal Right to Try Act.”
Approval of this bill would be a significant inflection point in the psychedelics-as-therapeutics saga and could go in one of two ways.
On the one hand, it could be a watershed moment by enabling patients with life-threatening conditions a legal route to psychedelics like MDMA and psilocybin in the US and serve as a gradual onramp for the broader practice of Psychedelic Assisted Therapy (PAT).
However, it could also be a massive disappointment.
Since the law was introduced by then president Trump in 2018 drug sponsors have been reluctant to grant access to their investigational products through RTT requests, and very few have done so. Therefore, such legislation could create a legal route to access in theory but not practice.
Let’s take a look.
To recap the major points in the ongoing RTT saga:
RTT laws allow patients with life-threatening conditions that are not eligible for clinical trials to request access to investigational drugs that are in active development and have passed Phase I trials from the drug’s sponsor (as we’ll see, these criteria may prevent access even if RTT eventually permits schedule I substances)
Manufacturers are reluctant to fulfill RTT requests for Schedule I substances without explicit approval and guidance from the DEA, so patient’s requests go wanting.
A palliative care physician and several patients with terminal conditions are suing the DEA (AIMS vs. DEA) to obtain permission to use psilocybin to treat end-of-life anxiety.
The DEA has obfuscated and prolonged the court proceedings by refusing to provide a final answer and indicating that the decision to allow Schedule I substances is in the hands of Congress.
This week the plaintiffs in AIMS vs. DEA expected to escalate their case against the DEA and return to court if the agency hadn’t yet issued a final decision. As far as I know, the DEA has not responded, and the case will return to court.
However, as we noted last week:
“A third possibility, since it is a federal agency and is answerable to federal elected officials, is that someone in power recognizes the growing interest and demand for psychedelics as therapeutics and sees this as a prudent route for onboarding the emerging practice of Psychedelic Assisted Therapy.”
And this is precisely what has happened.
If passed, the Right to Try Clarification Act, introduced by Senators Booker and Paul, would make it clear to the DEA that schedule I substances are permissible under RTT.
So, now this is a battle on at least two fronts: Judicial and Legislative, and my non-expert, non-attorney sense is that the allowance of Schedule I substances under RTT is only a matter of time.
False Hopes, Political Baggage & Unchartered Territory
As I posited last week, the complexity of PAT and requisite infrastructure required (specially trained therapists, long treatment duration, intensive preparation and follow-up, a conducive clinical environment, specialty pharmacy capabilities, etc.) make RTT access a compelling gradual approach for onboarding PAT before broader adoption:
“Granting access to psychedelic access to terminally ill patients under the supervision of a physician is a no-brainer.
In addition to the legal merits of the case, it is a logical and gradual way to start building the infrastructure for care delivery in medical settings before the FDA approval of MDMA and psilocybin.
Even the most risk-averse stakeholders could get on board with this.”
However, this was an incomplete assessment and failed to consider that sponsors of eligible investigational products have been reluctant or incapable of fulfilling patients’ requests for access through RTT.
“The number of patients who have benefited from state or federal right-to-try laws can currently be measured in single digits, and it is exceedingly unlikely that the pathway Trump extolled will ever be widely used.”
He also framed the issue this way (emphasis added):
“The main challenge is the drug sponsors and companies rather than any regulatory agency. Companies and their boards may not want to get involved early on with compassionate use. Some companies are too small to manage requests. Some fear bad publicity if someone on compassionate use dies. Some expect payment for making a drug available. Right-to-Try laws do not address any of these issues.”
RTT’s Political Baggage
Besides the logistical challenges and risk that keeps sponsors from fulfilling RTT, the law has some political baggage, aside from Trump.
RTT was initially conceived of and introduced by the Goldwater Institute, a libertarian think tank. Opponents of the law point to the libertarian origins of RTT as a vehicle for undermining the FDA’s authority to regulate access to new treatments.
This theme is even present in the joint press release from Booker and Paul (emphasis added):
“In other words, in limited conditions involving life-threatening illness and for drugs that have been proven to be safe, the federal Right to Try law removes the FDA out of doctor-patient decisions and reverts regulation back to the states. Under the terms of the federal Right to Try law, states remain free to permit or prohibit Right to Try use under their own laws.”
Given this pretense, drug sponsors’ reluctance to be perceived by the FDA as potentially subversive is entirely reasonable.
So, suppose this clarification act is passed, or the courts rule in favor of the plaintiffs against the DEA. In that case, it could put sponsors like MAPS, Usona and Compass Pathways, and others in an awkward position.
I sense many of us paying close attention to psychedelics have become numb to the magnitude of the situation—the prospect of regulatory approval of mind-manifesting, God-revealing, illicit substances that have been heavily stigmatized for 50 years.
The novelty is unparalleled if you step back and consider it, and it is helpful to occasionally remember this is unchartered territory.
For this reason, the sponsors, like MAPS, Usona, Compass, etc., to which RTT patients would make requests might be understandably squeamish about fulfilling these requests.
They are already on the frontier where there is plenty of risk as it is; why would they add more by participating in a program founded to undermine the FDA—the very agency they ultimately need to approve their projects?
In other words, if psilocybin, MDMA, and other psychedelic compounds are made available through RTT, legal access may still be unattainable.
Right now, it is very convenient for the DEA to be the enemy—a large, faceless, bureaucratic institution—but if, all of a sudden, the burden of access shifts from the DEA to sponsors, I sense it would also unfortunately redirect activists’ demand for action in challenging ways.
Psychedelics: Institutional Plastogens?
I am reluctant to extend the plasticity metaphor too far but I can’t help but speculate that the scientific, cultural, and political phenomenon of psychedelics, combined with the dire need for effective treatments amidst a growing mental health crisis might be sufficient enough to make the regulatory environment more malleable.
I wonder if intelligently applied lobbying, advocacy, and policy might open the door for a new era in the Right to Try saga, making it a viable vehicle that is not threatening to drug sponsors.
I tend to believe this is possible.
I don’t even want to touch this one, so in true “don’t read the paper, read the Tweets” style here’s a selection of responses to a relevant paper that receive much attention this week: The serotonin theory of depression: a systematic umbrella review of the evidence.
The final sentences of the Abstract:
“The main areas of serotonin research provide no consistent evidence of there being an association between serotonin and depression, and no support for the hypothesis that depression is caused by lowered serotonin activity or concentrations. Some evidence was consistent with the possibility that long-term antidepressant use reduces serotonin concentration.”
Further Reading & Developments
“Kabir Nath brings decades of experience in the health care industry to his new role, most recently serving as Senior Managing Director of global pharmaceuticals at Otsuka Pharmaceutical Co., Ltd. and previously as President and CEO of Otsuka’s North America Pharmaceutical Business, where he led the development of pharmaceutical products and digital solutions addressing complex mental health needs. Prior to Otsuka, Kabir held various leadership positions at Bristol Myers Squibb, a global biopharmaceutical company focused on innovative medicines for patients with serious diseases.”
Michael Pollan Appears on The Late Show with Stephen Colbert
Financial Times: Mind-altering adventures are becoming a huge – and unregulated – business. Which ones should you take?
“Life-changing. It’s one of the great soundbite promises of the wellness world. The pursuit of sleeker, longer-living, generally better versions of ourselves has begotten a global industry that was recently valued by McKinsey at $1.5tn.”
Thanks for reading! Have a great weekend!