We’re Launching a New Organization to Accelerate the Development of Safe and Effective Prescription Psychedelic Medicines. Here’s Why. 

By Jon Kostas

This November, voters resoundingly rejected several initiatives to expand state-led psychedelics legalization and decriminalization efforts. Safe, effective, and professionally administered psychedelic medicines have transformative potential to help treat patients with generalized anxiety disorder, major depressive disorder, post-traumatic stress disorder (PTSD), substance abuse disorders, and many other adverse health conditions. But the election results demonstrate that if we really want to expand patient access to these treatments, we must remain committed to the medical model and keep working to secure FDA approval for psychedelic medicines. 

I can speak to the transformative impact of prescription psychedelics, because they saved my life from a decade-long addiction to alcohol. In 2015, I was fortunate enough to participate in a year-long clinical trial at NYU Langone Health that studied the efficacy of psilocybin in treating alcoholism. I entered the study as a treatment-resistant alcoholic who was extremely uncomfortable with, and afraid of, using hallucinogens. One year later, I exited the study completely cured from my disease – and I’ve remained sober, from alcohol and from psilocybin, since completing the clinical trial nearly 10 years ago.  

A growing body of rigorous, peer-reviewed research and high-quality clinical studies show that psychedelic medicines have the ability to address the unmet needs of people across the country who experience a wide range of physical and mental health challenges. But frankly, many policymakers, regulators, and other key stakeholders in the health care community are in the dark about psychedelics, entactogens, and empathogens – and the associated medical conditions that each compound might be able to treat. They’re also unaware of the tremendous promise these treatments can provide for Americans experiencing PTSD – including veterans, first responders and domestic abuse, and sexual assault survivors – and for patients diagnosed with depression, anxiety, or substance use disorders, and many others in need of care. 

That’s why we’re working to increase the development and accessibility of these groundbreaking and potentially life-saving treatments to patients across the country by launching the Association for Prescription Psychedelics (APP). We’ll serve as a trusted and recognized voice on psychedelic medicines and highlight how government-sponsored research, public-private partnerships, patient-centric treatment, and health care infrastructure investments can support this innovative and emerging discipline. 

By helping advance responsible legislative and regulatory policies that drive innovation, increase funding for research, and enhance access and coverage for prescription psychedelic medicine, we can help patients in desperate need of efficacious treatment options and scores more who’ve been locked out of mental health care in the United States. Prescription psychedelics have the potential to modernize treatments and pharmaceutical interventions for a wide range of mental health conditions that haven’t been updated in decades, and in some cases, fall short of fully addressing patients’ evolving needs and complex conditions. 

As we work to give patients more options through medical psychedelics, we’ll also aim to foster better collaboration between industry, academia, health care professionals, and policymakers to help successfully integrate FDA-approved prescription psychedelics into our health care system. Improving relationships between these groups can accelerate ethical standards in research, manufacturing, access, and administration of prescription psychedelic medicine to ensure patient safety and well-being. It can also help improve the quality and delivery of care for the American people. 

Most importantly, we must put patients at the core of our efforts. Guided by scientific advisors who belong to prominent academic and research institutions across the country, we’ll champion patient-centered medical treatment guidelines and rigorous standards that not only adhere to robust research and evidence-based clinical practices, but also prioritize the needs and experiences of patients. Critically, we’ll ensure that FDA-approved prescription psychedelics are provided by accredited and experienced health care providers. 

As our nation continues to grapple with an unprecedented mental health crisis, we must expand the availability of proven tools and interventions. It’s time to embark on a new era of mental health treatment – one that supplies real, impactful, and life-changing outcomes for patients with debilitating conditions. Prescription psychedelics have that potential. Now we need to deliver. 

Jon Kostas serves as the executive director of the Association for Prescription Psychedelics and Chief Executive Officer of Apollo Pact. He was the first study participant to complete a randomized controlled trial studying the potential of psilocybin-assisted therapy (PAT) for alcohol use disorder at New York University. Jon credits PAT with curing his treatment-resistant alcoholism and saving his life.