New Senate Bill Would Give Terminally Ill the ‘Right to Try’ Psychedelic Therapies

U.S. Senators Cory Booker (D-N.J.) and Rand Paul (R-Ky.) have introduced a bill designed to give terminally ill patients access to certain controlled substances.

If enacted, the bill would clarify that patients receiving end-of-life care could access Schedule 1 controlled substances that have undergone a Phase 1 clinical trial, including MDMA and psilocybin. Reps. Earl Blumenauer (D-Ore.) and Nancy Mace (R-S.C.) will introduce a similar bill in the U.S. House of Representatives.

“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” Booker said in a statement. “Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies.”

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The legislation, dubbed the Right to Try Clarification Act, seeks to elucidate the applicability of existing law as it relates to patients receiving end-of-life care. A number of states have “Right to Try” laws on their books, and a federal law was instituted in 2018.

In a nutshell, these laws allow dying patients to try some treatments and drugs that have been through clinical trials but at not yet been approved by the U.S. Food and Drug Administration (FDA).

Following completed Phase 1 and 2 clinical trials, the FDA has already designated MDMA and psilocybin as “breakthrough therapies” that are safe and effective and demonstrate improvement.

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Once considered a radical idea on the fringes of medical practice, recognition and exploration of the clinical uses of psychedelics is gaining ground.

Psychedelics show promise in reducing anxiety and depression among terminally ill patients and fostering greater acceptance of mortality, according to a 2019 literature review in the journal Current Oncology.

Also, Johns Hopkins Medicine in 2019 established a Center for Psychedelic and Consciousness Research backed by $17 million in grants.

These therapies have also become big business, thanks largely to outpourings of venture capital and private equity dollars. Clinical psychedelics may become a $6.85 billion industry by 2027, Forbes reported last July.

“As a physician, I know how important Right to Try is for patients facing a life-threatening condition.” Paul said in a statement. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”

Support for Right to Try laws is not universal.

Some in the medical and academic fields have raised concerns these laws do not actually benefit patients, often because physicians are not required to prescribe them, insurance companies are not required to pay for them, and manufacturers are not required to provide them, according to a New England Journal of Medicine (NEJM) report.

Some also argue that the lack of available data on the effects of these substances on patients with specific conditions prevent patients from making informed decisions.

“Right-to-try laws, which have also been adopted in Michigan and Arizona, will have limited effect. They do not compel manufacturers and insurers to supply and pay for experimental therapies,” the NEJM report indicated. “They also cannot prevent the federal government from rescinding Drug Enforcement Administration registration of physicians who prescribe experimental drugs independent of the FDA.”

Opponents of these laws have also contended that these laws represent an effort to circumvent regulatory processes by legislators who seek to reduce federal health care oversight.

Some point out that event terminally ill patients can suffer harm as a result of untested treatments, and that Right to Try rules limit the actions those people can take to receive restitution, according to Dr. David Gorski, professor of surgery and oncology at Wayne State University.

“Basically, right-to-try laws are a solution looking for a problem or, as I like to call them, placebo legislation, Gorski wrote in a Science-Based Medicine article. “They make lawmakers feel good, but they do nothing concrete to help actual patients. It’s also important to remember that the real purpose of right-to-try laws is not to help patients, but to neuter the FDA’s ability to regulate certain drugs.”

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