Compass Pathways wants to be Big Pharma for psychedelic therapy — Quartz

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Compass Pathways wants to make psilocybin psychedelic therapy legal TURN ON, TUNE IN, DROP DOLLARS A millionaire couple is threatening to create a magic mushroom monopoly By Olivia Goldhill November 8, 2018 Almost 50 years since US president Richard Nixon declared psychedelic mushrooms illegal and “of no medical use,” mounting scientific evidence suggests he was wrong. A small, controversial company is now leading the effort to turn magic mushrooms into a pharmaceutical product, and is stirring up intense criticism from psychedelic experts who believe it’s trying to dominate the market. Scientific studies of psilocybin, the psychedelic compound in magic mushrooms, have been on the outskirts of serious medicine for decades. But a recent series of small studies has sparked a “psychedelic renaissance”: It seems the same psychedelic trips and loss of ego that made magic mushrooms a feature of ritual spiritual ceremonies for millenia also make them a promising treatment method for mental-health conditions such as addiction and post-traumatic stress disorder. These findings have laid the groundwork for larger, international studies that have the potential to lead to legal medicinal use of the drug. Compass Pathways has set itself up to be the first legal provider of psilocybin, having recently launched a massive clinical study across Europe and North America to test the drug as a treatment for depression. Last month, Compass’s psilocybin received “breakthrough therapy designation” from the US Food and Drug Administration (FDA) meaning the study will be hastened through the drug-development process. That puts Compass well ahead of other institutions working in this field—and a recently filed patent application could help the company stay ahead. Prior to founding Compass, George Goldsmith and Ekaterina Malievskaia, a married couple, did not have experience in psilocybin research or working in the pharmaceutical industry. They’ve made headway thanks to tens of millions in dollars from investors including Silicon Valley libertarian Peter Thiel and former Wall Street-executive-turned-cryptocurrency-investor Mike Novogratz, along with the expertise and guidance of many long-standing psilocybin researchers. (Neither Thiel nor Novogratz responded to requests for comment.) But many of those psilocybin experts now regret having helped the couple. Quartz spoke with 9 psilocybin experts who advised Goldsmith and Malievskaia, but today express concerns about the company’s motives and aims. These experts worked with Compass in different professional capacities: some had individual contracts, some were invited to attend Compass-hosted conferences or trips, and others worked (and some still do) for psychedelic research organizations that collaborate with Compass. All 9 raised questions about Compass’s intentions and professionalism, and worried that the company’s rush to bring the drug to market would create risks for patients. Six had opportunities to work further with Compass but turned them down as a result of their concerns. These experts are further troubled by the company’s business structure: Having first registered as a charity, Goldsmith and Malievskaia set up a for-profit corporation working towards the same ends just one year later, and closed their non-profit less than two years after that. And all 9 of these critics charge that Compass Pathways has relied on conventional pharmaceutical-industry tactics that could help them dominate the field, including blocking potential rivals’ ability to purchase drugs, filing an application for a manufacturing patent, and requiring contracts that give Compass power over academics’ research and are restrictive even by pharmaceutical-industry standards. A Compass company spokesperson says both Malievskaia and Goldsmith were unavailable to talk concerning the allegations in this article. The company did not respond to multiple requests for comment about specific incidents and allegations, though did provide two written statements in which Compass disputed all of the critics’ charges. “The allegations you have heard are simply false,” said a spokesperson in one of the statements, which charged (without providing specifics) that the critics that spoke to Quartz were misinformed or “malicious[ly] bias[ed].” “Patient well-being and safety are at the core of everything we do and every decision we take,” said Malievskaia in the other statement. “Nothing is more important to us. We are setting the highest standards in our clinical trial. Our treatment protocol and training programme has been designed by a group of the world’s leading experts in psilocybin therapy. It is consistent with the highest patient safety standards and has been reviewed and approved by regulators including the FDA.” Compass says its move from a nonprofit to a for-profit model was driven by its desire to develop psilocybin therapy at scale in a “sustainable manner,” and that the original non-profit “was created, run ...