Quantcast
Environmental News for a Healthier Planet and Life

Help Support EcoWatch

FDA Grants 'Breakthrough Therapy' Status to Psychoactive Psilocybin Mushrooms, Says Startup

Popular
FDA Grants 'Breakthrough Therapy' Status to Psychoactive Psilocybin Mushrooms, Says Startup
OllyPlu / iStock / Getty Images

By Dan Nosowitz

Various parts of the cannabis plant have already received full FDA approval; a drug consisting of cannabidiol, better known as CBD, has already been approved to treat two rare forms of epilepsy. Researchers have been pushing for years for relaxed legal status to study the possible medicinal benefits of hallucinogenic drugs, and now the FDA has given psilocybin—magic mushrooms—a conditional form of research approval, according to Compass Pathways, the company granted that approval.


Allowing researchers to study the effects of otherwise banned substances is tricky; the DEA's legal definition of schedule 1 drugs requires that they have "no accepted medical use." That's an immediate barrier to study, and also throws the drug into question if an "accepted medical use" is discovered. Can the drug even be a schedule 1 drug in that case? The DEA has generally refused to remove substances from the list, regardless of research, though CBD—which is not psychoactive at all—was recently rescheduled.

Anyway! Psilocybin has been casually used both recreationally and medicinally for decades, and international studies have indicated that controlled, somewhat low-level doses of psilocybin can be useful in treating depression. Earlier this month, researchers at Johns Hopkins wrote an analysis of existing studies, recommending that psilocybin be re-classified to enable more thorough study.

Compass Pathways says they have received designation as a Breakthrough Therapy treatment. That's the official name (rather than a hype-filled description) for an FDA program designed to expedite the approval process for drugs that have proved promising in treating serious conditions. As part of that designation, Compass Pathways will be able to conduct the largest North American clinical trial of psilocybin ever done: 216 patients with treatment-resistant depression.

From an agricultural perspective, growing psilocybin mushrooms is not particularly difficult, and guides abound online. But these mushrooms are not legally grown at any reasonable scale, and it's proved insanely expensive to buy approved psilocybin extract. This Quartz piece reveals that it can take up to a year for researchers to actually get their needed material, and that the price per gram can reach 13 times the street value. Compass Pathways actually grows their own and provides it at no charge to other researchers, because it can be so hard to get.

But this preliminary FDA approval, though very far from anything like decriminalization, might edge that door open a bit more for researchers who want to find out if psilocybin actually can help people.

Reposted with permission from our media associate Modern Farmer.

Colette Pichon Battle, attorney, founder, and executive director of the Gulf Coast Center for Law & Policy. Colette Pichon Battle

By Karen L. Smith-Janssen

Colette Pichon Battle gave a December 2019 TEDWomen Talk on the stark realities of climate change displacement, and people took notice. The video racked up a million views in about two weeks. The attorney, founder, and executive director of the Gulf Coast Center for Law & Policy (GCCLP) advocates for climate justice in communities of color. Confronted with evidence showing how her own South Louisiana coastal home of Bayou Liberty will be lost to flooding in coming years, the 2019 Obama Fellow dedicates herself to helping others still reeling from the impacts of Katrina face the heavy toll that climate change has taken—and will take—on their lives and homelands. Her work focuses on strengthening multiracial coalitions, advocating for federal, state, and local disaster mitigation measures, and redirecting resources toward Black communities across the Gulf South.

Read More Show Less

EcoWatch Daily Newsletter

A palm tree plantation in Malaysia. Yann Arthus-Bertrand / Getty Images Plus

Between 2000 and 2013, Earth lost an area of undisturbed ecosystems roughly the size of Mexico.

Read More Show Less

Trending

A home burns during the Bobcat Fire in Juniper Hills, California on September 18, 2020. Kyle Grillot / AFP/ Getty Images

By Stuart Braun

"These are not just wildfires, they are climate fires," Jay Inslee, Governor of Washington State, said as he stood amid the charred remains of the town of Malden west of Seattle earlier this month. "This is not an act of God," he added. "This has happened because we have changed the climate of the state of Washington in dramatic ways."

Read More Show Less
A new report from Oxfam found that the wealthiest one percent of the world produced a carbon footprint that was more than double that of the bottom 50 percent of the world. PickPik

A new report from Oxfam found that the wealthiest one percent of the world produced a carbon footprint that was more than double that of the bottom 50 percent of the world, The Guardian reported. The study examined 25 years of carbon dioxide emissions and wealth inequality from 1990 to 2015.

Read More Show Less
The label of one of the recalled thyroid medications. FDA

If you are taking medication for an underactive thyroid, check your prescription.

Read More Show Less

Support Ecowatch