The FDA’s Far-Out Plan For Psychedelics
The U.S. Food and Drug Administration (FDA) appears set to approve the psychedelic drugs psilocybin and MDMA for the treatment of post-traumatic stress disorder (PTSD) and depression, within 24 months of May 2022.
And yet, this major news has been flying under the radar. Luckily, your correspondent monitors the movements of the federal bureaucracy, to mine these nuggets of data.
Read this excerpt of a letter sent by Miriam Delphin-Rittmon, a psychologist who is currently serving as the Assistant Secretary of Health and Human Services for Mental Health and Substance Use, to U.S. Rep. Madeleine Dean (D-PA):
For the first time, the Biden administration has clarified (in writing, no less) that regulators will approve psilocybin and MDMA within the next two years for breakthrough, unconventional therapies for PTSD and depression.
Psilocybin is the psychoactive ingredient in magic mushrooms; MDMA also is known as ecstasy.
The ramifications of the letter’s assertions are vast. When approval happens, we’ll see an acceleration of investment activity. The time to position your portfolio is ahead of the event, not afterwards.
The research firm Global Industry Analysts estimates that the psychedelic drugs market will reach a value of $6.3 billion in 2026, up from $3.2 billion in 2021, for a compound annual growth rate of 14.5% during the five-year forecast period.
According to Fact.MR, the demand for psychedelic drugs increased at a compound annual growth rate of 6.3% over the past five years.
The increasing number of suicides in the military is a worsening social problem; psilocybin, MDMA, and other psychedelic drugs (as well as marijuana) are showing clinical evidence of preventing self-harm among active duty personnel and veterans.
The federal Centers for Disease Control and Prevention estimates that more than 17 former U.S. service members kill themselves per day…you read that correctly, it’s per day. Traumas from U.S. quagmires abroad, in places such as Iraq and Afghanistan, have resisted conventional pharmaceutical and psychiatric treatment.
Psychedelics remained banned at the federal level in the U.S. However, as part of the booming psychedelic tourism industry, thousands of veterans have traveled to foreign countries such as Mexico and Costa Rica for successful treatments with these mind-bending substances.
After demonizing psychedelics for years as part of its failed War on Drugs, the federal government is changing its stance.
Notably, the Department of Veteran Affairs (VA) in June began administering psychedelic substances to patients as a part of clinical trials in search of new treatments for PTSD, depression, anxiety, addictions, and a host of other ailments that disproportionately affect veterans of recent wars. At least five trials are currently underway, deploying such substances as LSD, MDMA, and psilocybin.
Lawmakers are getting into the act as well. On July 26, a bipartisan bill was introduced in Congress, co-sponsored by Sens. Cory Booker, (D-NJ), and Rand Paul (R-KY), to compel the U.S. Drug Enforcement Agency (DEA) to stop barring terminally ill patients from trying federally banned drugs which have passed early clinical trials.
The right to try experimental therapies has been part of federal law since 2018, but the DEA currently prevents patients with late-stage cancer from being treated with psychedelics such as psilocybin and MDMA, which are banned as Schedule I controlled substances.
“Studies have shown that psilocybin produces substantial and sustained decreases in depression and anxiety among patients with life-threatening cancer,” Booker stated about his bill. “While typically terminally ill patients are allowed to access drugs that are in FDA clinical trials, they are barred from accessing Schedule I drugs, despite their therapeutic potential.”
The medical establishment in recent years has shown greater respect for psychedelics as a legitimate avenue for scientific research.
In September 2019, Johns Hopkins Medicine launched the Center for Psychedelic and Consciousness Research to study how compounds such as LSD and psilocybin can be used to treat mental health issues. Johns Hopkins is considered the gold standard in the medical field.
As I’ve just explained, new money-making opportunities are increasingly emerging in the realm of psychedelic drugs. But how can you separate the solid investment bets from the crap shoots? You need guidance.
That’s why I urge you to read my new book: The Wide World of Weed and Psychedelics. My book is your definitive guide for making money in the thriving cannabis and psychedelics industries. Click here to get your copy.
John Persinos is the editorial director of Investing Daily.