Urgent Access to Effective Treatments to End the Agony of Cluster Headaches

Cluster headache is one of the most excruciatingly painful conditions known to medicine, compared by those suffering to having a red-hot ice pick driven into the eye. It is also called "suicide headache" because some patients choose to end their lives to escape the pain. There is no known cure, and standard existing medical options are unable to consistently and reliably prevent or abort attacks. An estimated 143,000 American adults endure this unbearable pain every year.

Countless patients have reported previously unattainable relief using certain compounds of the indoleamine chemical family, which interact with serotonin receptors.^[1] Psilocybin, LSD, 5-MeO-DALT and BOL-148 (a non-hallucinogenic derivative of LSD) have been found to be effective in preventing attacks, and N,N-DMT has been found^[2] to abort attacks within seconds and also have some preventative effects, even at sub-hallucinogenic doses. These are not isolated anecdotes: hundreds of patients have reported these effects in published scientific surveys, some clinical trials support these claims, and limited use in clinical settings has also demonstrated the effectiveness. In patient support groups and in conferences organized by a major patient advocacy group, patients relate the successes they have had in ending their pain through the use of these substances.

Based on an analysis of all the evidence, we have no doubt at all that these substances have medical value in preventing the excruciating pain of cluster headache where other therapies have failed. Although caution must always be exercised, these compounds are generally regarded as safe substances with low toxicity.^[3]

None of these substances has yet been approved for the medical treatment of cluster headache. Conducting large-scale clinical trials is complicated by the difficulty to recruit patients with this relatively rare condition, and the lack of funding to study these non-proprietary compounds.

In the US, there are currently no broad compassionate use provisions for these compounds to treat cluster headache. While the FDA's Expanded Access Program and federal Right to Try Act technically exist, these pathways remain effectively closed for these treatments. The DEA's classification of these substances as Schedule I ("no currently accepted medical use") creates enormous legal barriers preventing physicians from prescribing them even in cases of extreme suffering. Meanwhile, countries like Switzerland have established compassionate use provisions allowing physicians to prescribe psilocybin and LSD to cluster headache patients, and Canada has begun authorizing individual cases under its Special Access Program.^[4]

Most patients who use these substances are forced to do so illegally, as many of these compounds remain classified as controlled psychedelics, either growing their own psilocybin-containing mushrooms or obtaining these substances from other sources. The legal situation exposes these patients to potential criminal charges^[5], prevents them from obtaining substances of known purity and dosage, and makes patients wary to treat their cluster headaches with these substances, or to share relevant information publicly. The result is that many Americans suffer excruciating pain that could otherwise be treated safely.

This situation demands the same urgency as providing anesthesia for major surgical procedures.

We call on the US government to institute the following measures:^[6]