Just how soon might psychedelic-assisted psychotherapy be available aboveground, to the many people who stand to benefit from it? Before the F.D.A. approves a new medicine, the drug must survive testing for safety and efficacy in a three-stage sequence of trials, each of them involving a larger sample and more rigorous methods. When researchers recently brought to the F.D.A. the results of Phase 2 clinical trials of cancer patients who were given psilocybin and MDMA, they were stunned by the positive response of the regulators. Regulators told them they could move forward to Phase 3 with MDMA, the last step before F.D.A. approval. The F.D.A. is still considering when psilocybin trials can move into Phase 3. The agency wouldn’t comment on drugs in the approval process, but a researcher who attended one of these meetings told me the regulators seemed untroubled by the illicit status of the drugs in question or by the unique challenges of controlling studies of psychedelics. These meetings took place before a Trump-appointed F.D.A. commissioner was sworn in; it remains to be seen how the Justice Department under Jeff Sessions would respond to F.D.A. approval of psychedelics. The researchers felt heartened by the F.D.A.’s response. The message the scientists took away from the meeting was that they should raise their sights and not limit themselves to treating cancer patients, but rather test the drugs on the much larger population of patients suffering from major depression.
Thus encouraged, the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit that has been working for federal approval of psychedelics since 1986, will begin Phase 3 trials of MDMA-assisted psychotherapy this summer for the treatment of post-traumatic stress disorder, involving more than 200 volunteers at 16 sites in the United States, Canada and Israel. Later this year, pending F.D.A. approval, two Phase 3 trials of psilocybin — one for the treatment of major depression and the other for “psychospiritual distress” in cancer patients — are expected to get underway at Hopkins, N.Y.U. and a half-dozen other sites around the country.
Phase 3 trials, which typically involve hundreds of subjects at dozens of sites, can cost tens of millions of dollars — a cost ordinarily borne by the big pharmaceutical companies that stand to profit from approval. But Big Pharma has not demonstrated significant interest in psychedelics, and it’s not hard to see why: Psychedelic therapy is a rather square peg to fit into the round hole of psychopharmacology as we now know it. Patents on the molecules in question — LSD, psilocybin and MDMA — have long since expired (psilocybin comes from a common mushroom); the drugs, if approved, don’t need to be taken more than a few times; and as the C.I.I.S. program recognizes, psychedelic-assisted psychotherapy is a novel hybrid of pharmacology and talk therapy, making it uncharted territory for a pharmaceutical industry organized around the selling of pills.
But the obstacle of funding Phase 3 trials appears to have been recently surmounted. The Psychedelic Science Funders Collaborative (P.S.F.C.), a new Bay Area-based consortium of philanthropists including the hippie-soap entrepreneur David Bronner, the author and tech investor Timothy Ferriss and other donors both in and out of the tech community, has helped raise more than $63 million in charitable contributions, an amount that could be sufficient to complete the trials. The two main beneficiaries of these funds will be MAPS and Usona Institute, a nonprofit medical-research organization that is sponsoring forthcoming psilocybin trials. Rebekah Mercer, the Trump funder behind Cambridge Analytica and Breitbart, is also a donor to MAPS.
There is at least one corporation betting that psychedelic therapy will soon become a business. Founded in London by George Goldsmith, a health care industry consultant, and Ekaterina Malievskaia, a physician, Compass Pathways aims to become the world’s first psychedelic pharmaceutical company. (The couple, who are married, were inspired to expand access to psilocybin after Malievskaia’s college-age son was successfully treated by an underground guide with the drug for a debilitating case of depression.) Compass aims to be much more than a drug company, however. The company is developing a complete treatment package — consisting of a training program for therapists; protocols for orchestrating the entire experience; and the medicine itself — that it hopes to sell to health care institutions and national health services, first in Europe and then in the United States.
Its initial therapeutic target is treatment-resistant depression (patients who have failed to respond to at least two previous treatments); after an advisory process with the European Medicines Agency (the E.U.’s drug-regulating body), it has decided to conduct trials in eight to 10 sites across Europe. It is also in discussions with the F.D.A. to organize trials here. According to Goldsmith, Compass has already raised $13 million from investors in the United States and Europe, many of them from the tech community (Peter Thiel is an investor) but also institutional investors in the health care sector.
Phase 3 trials will take at least three years, but access to psychedelic therapy could come sooner than that. Under “expanded access” or “compassionate use” programs, patients who stand to benefit from therapies still deemed experimental can gain access to them before trials are complete. In the case of MDMA, this could happen as soon as 2020. [Continue reading…]