DOWNLOAD MP3: Kevin George ��� Call Me When You���re Sober

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.

Download the all-new Microsoft News app to receive up-to-the minute news from the world’s best sources – available now on iOS and Android

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.)

A millionaire couple is threatening to create a magic mushroom monopoly© Getty A millionaire couple is threatening to create a magic mushroom monopoly

 “You build this tower in a rush…and before you know it, it’s on fire and we can’t put it out.” 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. “You build this tower in a rush…and before you know it, it’s on fire and we can’t put it out,” says one academic, who requested anonymity for fear of retribution from Compass. 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 millionaire couple is threatening to create a magic mushroom monopoly© Getty A millionaire couple is threatening to create a magic mushroom monopoly 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 and closed in compliance with all laws in the UK and the US.” And Compass disputes allegations that its business practices are designed to dominate the psychedelics industry. “We do not control or seek to control the psilocybin market,” the company said in the statement, arguing that its intellectual property practices “enables us to develop a sustainable business model that will help us make psilocybin therapy available to as many patients as possible.” Some in the field agree that Compass is simply ruffling features in a field that’s not accustomed to for-profit corporations. “There’s a bit of professional envy, jealousy, whatever you want to call it, related to somebody starting a for-profit corporation,” says David Nichols, professor of pharmacology at Purdue University, and chairman of the Heffter Research Institute, a nonprofit organization focused on promoting psychedelic research.

There is no dispute that the depression medications market—valued at $14.51 billion worldwide in 2014 and predicted to grow to $16.80 billion by 2020—holds the potential of lucrative returns for investors. A company that both gains regulatory approval in North America and Europe for medical use of lab-synthesized version of psilocybin and controls the necessary intellectual property could have the power to determine both the costs of and treatment methods for medical-grade synthetic magic mushrooms.

The story of Compass is a story of what happens when business concerns, driven by the clinical potential of a naturally occurring substance, enter a field unaccustomed to them. The study of psychedelics has long existed on the fringes of medical science. Now that it’s on the verge of legitimacy, one company’s alleged maneuvering to seize any gain is sparking deep feelings of betrayal, and serious questions about the practices that it’s using to get there.

A charitable beginning

  “Tapestry faced lingering questions about..whether they facilitated greater ‘coziness’ between regulators and the regulated.” Before Goldsmith started Compass, he was involved in work that made him especially well-suited to wrangling with regulatory agencies for the medicinal approval of a formerly illegal drug. In 2002, he founded a company called Tapestry Networks, which creates “leadership networks” in government, financial services, and health care. Drug developers made up a major client group, and paid Tapestry Networks to arrange meetings with medical regulators, including the FDA and European Medicines Agency (EMA), with the goal of accelerating drug approvals, according to Goldsmith’s bio for a 2016 conference. An April 2014 Harvard Business School case study on the company notes that “Tapestry faced lingering questions about the…legitimacy [of all meetings the company set up] and whether they facilitated greater ‘coziness’ between regulators and the regulated.” Goldsmith stepped down as chairman of the company in order to run Compass. Neither he nor Tapestry Networks responded to requests for comment about the legitimacy of Tapestry Networks’ meetings.

Saint Petersburg, Russia© Getty Saint Petersburg, Russia

Malievskaia, meanwhile, grew up in Russia, where she got a medical degree from St. Petersburg Medical Academy, according to her Compass bio. She later moved to New York, where she received a master’s degree in public health from New York University Medical School in 2000. The health care website Vitals lists her as a doctor specializing in internal medicine and practicing in New York.

Otherwise, not much is known about Goldsmith and Malievskaia’s personal histories, or how they met, say multiple people who worked with them.

When Goldsmith and Malievskaia first started meeting with psilocybin academics and going to conferences about psychedelics in 2013, they talked about using psilocybin to treat end-of-life anxiety for terminally ill patients, rather than depression. In June 2015, they set up C.O.M.P.A.S.S. (“Center Of Mental health Pathways And Support for Self-directed care”), a charity organization based in California, focused on this cause.

 The charity owned intellectual property during this time, which Goldsmith and Malievskaia later transferred to personal ownership. While C.O.M.P.A.S.S. operated as a charity, Goldsmith and Malievskaia turned to numerous high-profile psilocybin researchers and psychologists for guidance. The couple asked many of these prominent figures to serve as informal advisors for their nonprofit, and learned from these experts’ years of research while gaining legitimacy from their association with them. According to C.O.M.P.A.S.S.’s 990 tax forms1, the charity owned intellectual property during this time, which Goldsmith and Malievskaia later transferred to personal ownership. Compass did not respond to a request for comment about the nature of this intellectual property.

Quartz spoke with four researchers who advised C.O.M.P.A.S.S. from 2014 to 2017 (when they were told they were aiding a charity organization) at Goldsmith and Malievskaia’s request, but now have serious questions about the couple’s business practices. All four voiced concerns that, if Goldsmith and Malievskaia rush to develop the drug while keeping costs low, it could unnecessarily heighten risks for patients. And that, if the company does put shareholder interests above patient wellbeing, the drug could end up more expensive for patients than it needs to be.

These academics also described behavioral patterns that undermined their trust in the couple. They detailed how Goldsmith and Malievskaia lavished them with attention—invitations to their home, expensive dinners, and all-expenses-paid trips to the Isle of Man, a self-governing British Isles island in the Irish Sea—only to go abruptly quiet once they’d seemingly gathered the information they needed. Quartz has seen documents that support these allegations. Compass, Goldsmith, and Malievskaia did not respond to requests for comment about these trips.

 “It felt seductive. It was very flattering, but there was something odd about it.” The trips to the Isle of Man were pitched to these experts as a chance to visit the hospice where C.O.M.P.A.S.S. planned to set up trials of a psilocybin-treatment program for end-of-life anxiety. Goldsmith and Malievskaia paid for their guests’ flights, accommodation at the luxury Claremont Hotel, and meals, in order to raise interest in the venture, according to these experts and documents seen by Quartz. The researchers who spoke with Quartz say they were happy to volunteer their time and work to C.O.M.P.A.S.S., without a formal contract or payment, because they believed they were working with a charity for a worthwhile cause. A few say they found it odd to be flown to the Isle of Man and put up in such luxury, especially without a formal working relationship, but believed being there would help garner acceptance for the work from health officials and politicians on the island.

A millionaire couple is threatening to create a magic mushroom monopoly© Getty A millionaire couple is threatening to create a magic mushroom monopoly

“It felt seductive. It was very flattering, but there was something odd about it,” says one of the psilocybin researchers, who requested anonymity out of concern for potential professional repercussions for speaking about Compass.

Those who visited describe the hospice as luxurious, with state-of-the-art technology, huge private rooms, and extensive gardens. But several visitors say the place appeared to be empty, with hardly any patients. (The hospice today acknowledges doing research on psilocybin years ago, but declined to go into specifics.)

Goldsmith and Malievskaia also introduced their guests to politicians on the island, and emphasized their own political clout. “We’ve gotten a regulatory and legislative approval for all schedule 1 drugs for research on the island,” Malievskaia wrote in an April 2015 email sent to psilocybin researcher Katherine MacLean (and later viewed by Quartz), who was advising the couple.2 “John Shimmin got promoted again and now heads the Cabinet Office.” Shimmin did not respond to requests for comments. There have been no allegations that there was anything illegal about these politicians’ dealings with Goldsmith and Malievskaia.

MacLean—who’d conducted clinical trials on psilocybin at Johns Hopkins University from 2012 to 2014 and became director of the Psychedelic Education and Continuing Care Program in New York in 2015—was drawn both personally and professionally to the Isle of Man project. “[Goldsmith and Malievskaia] befriended me and created a lot of trust and a very strong bond in the beginning,” she says. MacLean’s sister had recently died of cancer, and so she felt deeply personally invested in Goldsmith and Malievskaia’s plans for the Isle of Man hospice. “They really played to my personal interests in psychedelics for end-of-life care because my sister had died,” she says. MacLean stayed with the couple in their home, spoke to them frequently, and introduced them to others in the field. She also created a C.O.M.P.A.S.S. research protocol that was based off her earlier work at John Hopkins.

In January 2016, MacLean discovered that what she believed to have been a close relationship with Goldsmith and Malievskaia was over as suddenly as it had begun. MacLean emailed the couple to ask if she could mention her discussions with C.O.M.P.A.S.S. in her upcoming Tedx Talk, and Malievskaia replied that she could not. “We have a solid communication plan that is updated regularly and shared with all our partners,” Malievskaia added. “The project has changed significantly since our exploratory discussions last summer.” The subtext was clear: MacLean was no longer on board. She followed up by email to double check, asking: “As far as I understand it, and please correct me if I’m wrong, I’m no longer connected with you and your projects in any way.” Malievskaia confirmed it. MacLean was out. Compass did not respond to requests for comment about this exchange.

Compass acknowledged that it had instances of poor communication. “In our drive to get things done, we may have unintentionally alienated some people by not communicating clearly enough about our transition, which we do regret,” the company said in a statement to Quartz.

Switching to a for-profit corporation

Throughout 2016, the four experts who’d been collaborating with C.O.M.P.A.S.S. noticed communication had suddenly ceased. “You’d get a flurry of communication when they wanted something, then it would stop and everyone wondered what happened,” says one of the researchers. While working as a nonprofit, Goldsmith and Malievskaia expressed a keen interest in collaboration and data sharing, values that aligned with those of most other psilocybin researchers. At the Interdisciplinary Conference on Psychedelic Research in Amsterdam in June 2016, Goldsmith emphasized his belief in a collaborative approach. “We need open science,” he said. “And that means that we really need to be sharing data, so that the rising tide lifts all boats. This is not something that I think we can withhold.”

Yet, that very month, without telling the four experts who had been advising them, Goldsmith and Malievskaia created the for-profit company, Compass Pathways, based in London.

The timing raises questions about when Goldsmith and Malievskaia knew that they were planning to switch to a for-profit model, and whether they failed to disclose this to their collaborators while continuing to get valuable information from them under the guise that they were running a charity. Though Malievskaia and Goldsmith created their for-profit company in June 2016, Quartz has seen an article Malievskaia wrote for the upcoming winter 2018 edition of MAPS Bulletin, in which she states that she and Goldsmith only decided to start the for-profit in February 2017.

There are also questions about whether C.O.M.P.A.S.S. functioned as a legitimate charity. According to the organization’s form 990 US tax filings from 2015 to 2017, Goldsmith and Malievskaia poured $554,953 of their own money into the tax-exempt charitable structure, spending $75,729 on travel, $17,535 on accommodation, and $146,351 on promotion.

 Law professors say the tax documents…warrant explanation from Compass or else investigation from the California attorney general.  At the same time, they were using the charity organization to make the connections and build awareness of “C.O.M.P.A.S.S.” that they would later use for their for-profit venture “Compass Pathways.” It is illegal in the US to use a charity to advance personal or for-profit interests, according to two law professors who reviewed the documents for Quartz. The 990 tax forms are not detailed enough to conclusively show any abuse occurred, but both law professors say the tax documents certainly show signs of behavior that is questionable for a nonprofit, and warrant explanation from Compass or else investigation from the California attorney general. These experts say it is especially concerning that C.O.M.P.A.S.S. continued to spend the charity’s money after Malievskaia and Goldsmith had established their for-profit venture, raising doubts about whether the costs were truly in the interests of the charity, rather than the for-profit business. “The travel costs makes you wonder who was doing the travelling, what level of accommodation did they have?” says Lloyd Hitoshi Mayer, an expert in nonprofit tax law and professor of law at the University of Notre Dame. Compass did not respond to specific questions about their spending.

Further, Brian Frye, a law professor at the University of Kentucky with a focus on nonprofit organizations, says it would be “improper”—not illegal, but unethical and “certainly not in the spirit of the charity”—to persuade scientists to help advance a charitable cause, only for the owners to then use this knowledge to further their for-profit ends. “They’re basically getting assistance from people under false pretenses,” he says. Compass, Goldsmith, and Malievskaia did not respond to requests for comment on this point.

The 990s also suggest that C.O.M.P.A.S.S. used its nonprofit status to obtain intellectual property that would later become Goldsmith and Malievskaia’s. In 2015, C.O.M.P.A.S.S. claimed $217,671 worth of “intangible assets” on its tax forms.

a screenshot of text: Compass Pathways 2015 and 2016 990s© Provided by Atlantic Media, Inc. Compass Pathways 2015 and 2016 990s

In its 2016 taxes, C.O.M.P.A.S.S. stated that it held no assets, but then in 2017, the organization reported transferring $142,252 worth of intellectual property to the private ownership of Goldsmith and Malievskaia.

a screenshot of text: Compass Pathways 2017 990© Provided by Atlantic Media, Inc. Compass Pathways 2017 990

The documents don’t say what this IP was or from where it was obtained, and Compass, Malievskaia, and Goldsmith all did not respond to questions about it.

“It looks fishy,” says Fyre. “Charitable organizations are supposed to be operated to the benefit of the charity, and the assets dedicated to charitable purposes.” Legally, when a charity is dissolved, its remaining assets must be distributed to other charities. Judging by C.O.M.P.A.S.S.’s 990s, both law professors say it looked as though Goldsmith and Malievskaia took their charity’s assets for their own, non-charitable uses. Compass did not respond to requests for comment on this point.

 “It looks fishy.”  Compass did not address multiple requests for comment about specific allegations in this article, including questions about their charity’s intangible assets and spending. “The nonprofit COMPASS was funded solely by George Goldsmith and Ekaterina Malievskaia. Nobody else provided any funds, and the nonprofit was created, run, and closed in compliance with all laws in the UK and the US. We take our ethical and legal responsibilities very seriously, and refute any allegations to the contrary.”

Compass told Quartz that the company transitioned to a for-profit model, “because we believe the latter is the best vehicle for developing psilocybin therapy on a large scale, for patients in need, in a sustainable manner.”

In a March 2016 email to several C.O.M.P.A.S.S. advisors, obtained by Quartz, Malievskaia announced that she and Goldsmith had decided that the Isle of Man trial “would not provide a meaningful contribution to justify the expense, more importantly, it would not lead to the regulatory approval in the EU.” She added that C.O.M.P.A.S.S. had begun looking into psilocybin palliative care research at multiple sites across Europe.

Malievskaia and Goldsmith formed their for-profit corporation, Compass Pathways, three months later. But several of Goldsmith and Malievskaia’s early collaborators say they first heard of the company and its new focus on depression from a September 2017 Financial Times article. In the following months, the couple told numerous publications that they became interested in psilocybin as a treatment for depression after their son became severely depressed in 2013 and benefited from psilocybin therapy delivered by an “underground guide” in the Netherlands. “Ekaterina has always emphasised that the COMPASS story is not about her son, but is the story of access to innovation, particularly for those who cannot afford it,” said Compass in a statement to Quartz.

In December 2017, Compass Pathways issued a press release naming Thiel as one of its major investors, along with Novogratz’s New York-based firm Galaxy Investment Partners, which focuses primarily on blockchain and cryptocurrency technologies, and German serial entrepreneur Christian Angermayer. In 2018, Angermayer formed a startup called Atai Life Sciences, which now owns 25% of Compass. In October, Angermeyer told Business Insider that Atai’s mission is to create a “virgin market” for psilocybin studies, specifically as a treatment to fight aging and extend life. (Angermayer, Thiel, and Novogratz did not respond to requests for comment.)

All of this was surprising to many of those who’d advised Goldsmith and Malievskaia on their nonprofit charitable venture. “I thought I had potentially contributed to something that was not at all my understanding of what they had intended from the beginning,” says MacLean.

Magic mushrooms medicine© Getty Magic mushrooms medicine

Using pharma tactics to secure medical magic mushrooms

To research psilocybin as a medication for depression, Compass needed to get hold of the drug, and a lot of it. The psychedelic compound occurs naturally in 180 species of fungi, but not in a form pure enough to meet the standards of government drug-research regulators. It’s expensive and difficult to synthesize the drug to the FDA’s “good manufacturing practice” (GMP) standards, and chemists need a special license to work with the illegal substance.

In 2017, Malievskaia and Goldsmith contracted Onyx Scientific, a UK-based company that provides drug-development services to biotech and pharmaceutical firms, to create the GMP psilocybin they needed to conduct a clinical trial. A representative for Onyx Scientific said the company had no comment.

When Quartz first spoke to Compass, for an article published in March 2018 about how academics acquire psychedelic drugs, Malievskaia said the company went through this extremely expensive process without realizing there would be demand for the drug from academics and other research centers. “We didn’t do it with the goal of selling it and making a quick buck on it,” she said at the time. “We conduct our own trials, but thinking about patient experience and patient outcomes rather than selling a drug.”

Yet Compass has taken steps that seem to prioritize its own financial benefit. Though the company provides the drug to independent researchers, it does so only on the condition that it can control the published results and any potential patents that come out of the work. Quartz has obtained three separate contracts that Compass sent to two independent academic researchers, all of which stipulate that Compass can block the publication of research. In the wording of two of the contracts, Compass can block the public discussion of any study results or the publication of any academic papers if it determines that would interfere with “interests of secrecy or commercial interests” of the company. The contracts also make clear that Compass alone will financially benefit:

“If the research results in an invention or substance or know-how that is commercially useful, Research Institution hereby grants COMPASS an exclusive, royalty-free, perpetual, worldwide, transferable and self-licensable right to use such invention for commercial and research purposes.”

 It’s “pretty stunning” for Compass to potentially block research that would interfere with “interests of secrecy or commercial interests.” These are severely restrictive contracts even by pharmaceutical industry standards, according to John Abramson, lecturer in health care policy at Harvard Medical School, and have the potential to distort the publicly available body of scientific knowledge. The available data back Abramson up: a 2005 survey of 107 medical school researchers found that more than 85% would not allow industry sponsors to revise manuscripts or decide whether results should be published.

Abramson says it’s “pretty stunning” for Compass to potentially block research that would interfere with “interests of secrecy or commercial interests.”

“The concerns are enormous,” added Abramson, who has consulted as an expert for plaintiffs in pharmaceutical litigation. “It challenges the validity of the entire body of knowledge that physicians rely on to make decisions in the best interests of their patients. It means that body of knowledge is not trustworthy.”

“We do retain rights over research work that uses our psilocybin,” said Compass in a statement to Quartz. “If research using our psilocybin results in something with this potential, we would be interested in taking this from the research lab through regulatory approval and into medical practice, ensuring and accelerating patient access. We also retain the right to defer publication of research until patent claims have been filed.”

In October 2017, Compass filed a UK patent request for the “preparation of psilocybin, different polymorphic forms, intermediates, formulations, and their use.” It’s not clear what exactly would be covered by the patent, since the UK’s intellectual property office does not publish full applications until 18 months after filing, and Compass would not share details.

In the US, UK, and most countries around the world, something can only be patented if it is a new discovery. Since countless academics and researchers have publicly discussed the chemical components of psilocybin, the compound itself cannot be patented. But Compass could patent a new manufacturing method, which would force others who want to synthesize psilocybin to find an alternative means of doing so. That, says Boston University health law professor Kevin Outterson, “could give you a very significant cost advantage,” which could be used to make it more difficult for others to enter the market.

This sort of patent is not unusual in the pharmaceutical sphere, but it is new to psychedelics. MAPS, which is currently conducting research into MDMA, the psychedelic drug commonly known as ecstasy or molly, has repeatedly emphasized that it does not file for patents. Rick Doblin, the head of MAPS, even hired a patent attorney to develop what he calls “an anti-patent strategy” to ensure that no company—not even MAPS—could patent therapeutic uses of MDMA. In a statement to Quartz, Compass Pathways said that “our patents will not restrict research in the field, or preclude others from creating different solutions for the synthesis and formulation of psilocybin.”

Finally, Compass has an exclusive contract with Onyx Scientific, one of the few laboratories in the world that has the capacity and approval to create GMP psilocybin. The contract prevents Onyx from working with Compass’ competitors, according to multiple sources and documentation obtained by Quartz. In July 2017, Usona Institute, a nonprofit medical research organization, tried to work with Onyx to produce psilocybin in order to study its potential as a depression treatment, but was told that it could not due to Onyx’s contract with Compass. According to multiple sources familiar with the matter and documentation obtained by Quartz, Compass told Usona it would only sell its psilocybin to those doing academic research, and wouldn’t sell to anyone who was doing clinical research to get psilocybin medically approved. Onyx, Usona, and Compass all did not respond to requests for comment on this point.

Though limiting potential competitors is a conventional business move, it shocked those who had advised Goldsmith and Malievskaia in the spirit of open science, and now realized the couple appeared to be blocking nonprofit research in turn. Compass’s alleged efforts to prevent Onyx from working with Usona have considerably slowed down Usona’s attempts to conduct its own trials with psilocybin. Though a handful of manufacturers have a license to work with psilocybin, a license is no guarantee of success. Usona has had major delays in trying to obtain the drug, according to multiple sources familiar with the matter. No one else has publicly stated that they’ve been able to synthesize the necessary quantities of the drug at GMP standards for Usona.

“Far from blocking USONA from psilocybin, we have previously offered to work with them, but they declined,” Compass told Quartz. Indeed, Goldsmith and Malievskaia did offer to work with Usona. But, according to multiple sources and documentation obtained by Quartz, Compass would not sell its drug to Usona—it would only license it, and for a higher price in sales to academic institutions. Compass did not respond to requests for comment on this point.

The two institutions did not discuss particular terms. Though it’s technically possible that Compass could choose to share any financial benefits, sources working in psychedelic drug development say a licensing agreement would typically be used to ensure that, should Usona conduct any research that contributed to government approval of psilocybin, Compass alone would profit. Several psilocybin academics and psychologists, who were not party to Compass’s exclusivity contract, cited the deal as a sign that it could potentially try to control the global supply of legal psilocybin. And they’re concerned that the pending UK patent could allow Compass to tighten its grip.

In a statement to Quartz, Compass says its exclusive manufacturing contract with Onyx “is the best way to ensure that we maintain a good supply of the highest quality product in a way that is sustainable for, and accessible to, patients,” and helped it “develop a sustainable business model that will help us make psilocybin therapy available to as many patients as possible.”

Magic Mushroom© Getty Magic Mushroom

A prickly response to criticism

Four psilocybin experts who advised Goldsmith and Malievskaia on Compass’s current trial say their questions about the company’s focus on shareholder interests and its level of therapist training were met with hostility.

In June 2017, Goldsmith and Malievskaia organized a two-day retreat for around 30 psilocybin experts at Tyringham Hall, a 25-bedroom mansion just outside of London, built by the renowned architect John Soane. At the time, Goldsmith and Malievskaia did not yet have permission for their multi-site trial across Europe and the US, but they were confident that they would get it, and wanted to discuss plans for the study, according to experts they invited. On the second day of the conference, several of the guest experts say they raised concerns about training so many psilocybin therapists so fast. They also were worried about Compass’s plan to use therapists who had no personal experience taking psilocybin, which Doblin and other psilocybin experts confirmed is a crucial training feature in existing psychedelic studies. Compass did not respond to requests for comment about the value of therapists’ experience with psilocybin.

“It’s such a weird experience and if [patients] realize that the therapist hasn’t gone through it themself, how can they trust them in saying that, ‘everything will be fine?’” says one researcher who attended the Tyringham Hall meetings. This researcher compared a therapist with no experience of psilocybin conducting psychedelic therapy to a scuba-diving instructor who’s never been scuba diving and is “on the phone talking with the people under the water who are learning it.”

 “We’ve worked so hard to make this happen. If they f**k up, the whole community will suffer.” Indeed, Doblin and other psilocybin experts say it’s standard practice in all psychedelics research (which includes psilocybin, MDMA, and LSD), for therapists to have experience with the drug they’ve given to patients. Doblin explains that psilocybin therapy can be a terrifying experience. Patients experience the death of their ego, often fear that they’re dying, and confront disturbing features of themselves and reality. A therapist that has not experienced this themselves could well be frightened by the patient’s experience, says Doblin. Plus, it’s hugely valuable for patients to know that therapists have experienced similar and survived.

Many people raised these concerns at the Tyringham Hall conference. Two attendees Quartz spoke with say they were further worried that Compass was not receptive to hearing about these issues. “We’ve worked so hard to make this happen. If they f**k up, the whole community will suffer,” says one of those experts. Compass did not respond to questions about the conference.

Other psilocybin researchers who did not attend the Tyringham Hall conference, but worked with Goldsmith and Malievskaia in different contexts, echoed the fear that the couple are resistant to criticism. MAPS and Compass use some of the same therapists in their trials and have informally agreed to share information and support each other’s work. But three MAPS employees told Quartz that they worry MAPS’ association with Compass could undermine MAPS’s public-service approach to drug development.3 So many MAPS employees were concerned about Compass’s for-profit approach to drug development and how it could affect patients that, in August 2018, Doblin invited Goldsmith to a MAPS board meeting to address some of these worries.

At the meeting, Natalie Lyla Ginsberg, director of policy and advocacy for MAPS, asked, “Can you tell us what Compass is doing to differentiate yourself from other pharmaceutical companies who put shareholders before patients?” Ginsberg says she carefully worded the question specifically to avoid upsetting Goldsmith, and was astonished when he started crying in response. “How can you ask me that?” Goldsmith said, according to several people who were present. “Do you know my track record? It speaks for itself.”

Doblin says he understands Goldsmith’s frustration at attempting to prove something that could only be born out with complete certainty by future corporate behavior. But several MAPS employees say they felt Goldsmith avoided answering the question, and responded in a way that shut down further conversation. “I understand it’s a difficult question, but I think people in pharmaceutical delivery especially have a special duty to deeply consider the implications of being forced to maximize profit for shareholders,” says Ginsberg. Compass did not respond to questions about the MAPS board meeting.

During this period, Malievskaia also complained to Doblin that some of his MAPS employees had “liked” Facebook posts that were critical of Compass. In Doblin’s view, Malievskaia is new to both her position and the kind of criticism she’s been getting since taking on the role. “I think it’s legitimate to want to know why are people criticizing them,” he says. But MAPS employees say they felt uncomfortable that Compass was monitoring their social media activity and reporting back to their boss.

Compass, Goldsmith, and Malievskaia did not respond to requests for comment on any of these three incidents, or to questions about their attitude to criticism generally.

People talking in circle at support group© Getty People talking in circle at support group

The rush to train therapists

As with any drug—especially those being tested as a potential cure for depression—psilocybin comes with risks. “It’s one thing to try out a new business model. It’s another to use a really vulnerable population of people who are at risk for suicide and test out your model that you have no experience with,” says MacLean.

Compass’s trial on depression involves 216 patients in 12 to 15 sites across Europe and North America. Psilocybin sessions started this summer in the UK and the Netherlands, and other research sites will be added in the coming months. Investors have a lot riding on it being successful: Compass told Business Insider it has raised $38 million in funding.

To date, there has been only one small study on psilocybin therapy as a treatment for depression, which included 19 patients and no control group. It’s a huge leap from the existing research to Compass’s trial.

 “I’ve also seen near catastrophes happen without any way of predicting them.” Using psilocybin as a medical treatment is not the same as taking the drug recreationally. In a clinical setting where the drug is used to help those with mental illnesses, it is an intense, experimental form of treatment that can have extreme consequences. “I’ve seen synthetic psilocybin work really well in a laboratory setting with an excellent clinical team with a lot of experience,” says MacLean. “And I’ve also seen near catastrophes happen without any way of predicting them.”

Several psilocybin experts say that, based on the existing research, they were worried about Compass’s attempts to roll out the treatment to so many patients. These experts further noted Compass’s study protocol includes a number of aspects that appear reflect a desire to reduce costs, including shorter-than-standard therapist training. According to the experts Quartz spoke with, companies running clinical trials typically face pressure to keep costs low so that, if the FDA were to approve the treatment under study, insurance providers would be willing to cover it in that approved form. Several of these experts told Quartz that they were concerned that Compass’s trial was designed to be fast, large, and inexpensive, and that it could create risky situations for patients.

“I think they’re going too quick, they’re overly ambitious,” says one psilocybin researcher. “When people go off the rails with this treatment, it can be quite dramatic and problematic.”

Bill Richards, a psychologist who co-founded the psychedelic research program at Johns Hopkins and is working with Compass to help train its 40 therapists, worked on 2016 study on psilocybin to treat anxiety and depression in those with life-threatening cancer, in which one patient killed himself midway through the study. Though the FDA and university review board declared the suicide was not related to the study, Richards is well aware of the risks of psychedelic research.

A millionaire couple is threatening to create a magic mushroom monopoly© Getty A millionaire couple is threatening to create a magic mushroom monopoly

“It’s called the ‘disappointment reaction,’” he says, when patients expecting to benefit massively from psilocybin are devastated not to be immediately cured. Richards says there’s further risk as participants in the Compass study must be weaned off any antidepressants they’re taking beforehand, as they increase the likelihood of negative reactions to psilocybin. “That’s why we have informed consent and we do it as carefully as we can, hoping the benefit will be greater than the risks,” he says. According to Compass’s website, participants must be referred by their doctor or psychiatrist.

Those who advocate for the use of medicinal psilocybin say it should be used in conjunction with therapy, under a therapists’ supervision—not ingested by the patient at home by themself. Patients must first meet their therapists, and have several sober sessions with them to build trust. They then have an appointment where they ingest the psilocybin (in Compass’s trial, they’re given the drug in capsule form), and trip for around six to nine hours while in a therapist’s office, under their guidance. There’s no major physical danger (indeed, studies have found magic mushrooms are perhaps the safest of the common recreational drugs), but the experience can be psychologically disturbing. The patients then return to see their therapists following the psychedelic experience, to discuss the trip and how they’re feeling.

Richards says the therapists working on Compass’s trial get a weekend of in-person training. There are “lectures and demonstrations and roleplay and discussion,” Richards says. “They have access to a library of videos and written information. They’re introduced to the work by assisting an experienced therapist. And then they receive supervision and feedback as they develop their expertise.”

 Several psilocybin experts Quartz spoke with say two days is not enough in-person training time. Several psilocybin experts Quartz spoke with say two days is not enough in-person training time. Though training videos may contain useful information, they don’t allow for in-person evaluation of therapists, which experts say are essential. Many potential therapists don’t pass these evaluations: “You find out if someone’s mentally healthy enough to be a mental health professional and the attrition rate is really high,” says one expert familiar with psychedelic therapist training.

Compass has not published the details of its therapy training, but the program as described by Richards is considerably shorter than the training required by MAPS for therapists working on its research into MDMA as a treatment for PTSD. (Compass did not respond to questions about its therapist training.) The MAPS program, which is published online, involves at least eight days (60 hours) of in-person training and includes a 14-hour online course, at-home assignments, a second period of either video-conference or in-person assessment (depending on need), and, finally, evaluation, and clinical supervision.

MAPS therapists are also invited to experience MDMA as subjects in a five-day, FDA-approved study on the psychological effects of MDMA-based therapy. Doblin says this is not required, but strongly encouraged, and “nearly all” the therapists choose to participate. In addition, he says he would be extremely reluctant to hire any a therapist without personal experience of psychedelics for the study and isn’t aware of any therapists who took part in the MDMA study who didn’t have personal experience of the drug.

To date, there has been only one small study on psilocybin therapy as a treatment for depression, which included 19 patients and no control group. It’s a huge leap from the existing research to Compass’s trial.© Getty To date, there has been only one small study on psilocybin therapy as a treatment for depression, which included 19 patients and no control group. It’s a huge leap from the existing research to Compass’s trial.

 “We avoid the question of ‘have you taken a psychedelic and if so, when and where?’” Compass set up a psilocybin trial for healthy volunteers hoping that some therapists could participate, but Richards says that many were not able to. The therapists are told to respond to questions about whether they’ve taken the drug by saying that “all therapists have experience in altered states of consciousness.” Such altered states could include a “runner’s high, natural childbirth, meditation,” says Richards. “We avoid the question of ‘have you taken a psychedelic and if so, when and where?’”

In an email, Richards wrote that the trial includes “sufficient preparatory and integrative time…to ensure safety and a high probability of benefit.” On the phone, Richards added that, “You define the basic package as economically as possible,” but that, if a therapist felt they had not established enough trust with a patient, they had the option to add further therapy sessions. “You want safety and efficacy, but you want to do that as reasonably as possible,” he says.

As to concerns about the length of Compass’s therapists’ training, Richards notes that every project has its own unique demands. “No sponsor or PI [Principal Investigator] will permit employees to be therapists who lack minimal skills and the spiritual perspectives that seem to be beneficial,” he wrote in an email.

“Patient well-being and safety is at the core of everything we do and every decision we take,” said Compass in a statement. “Nothing is more important to us. We are setting the highest standards in our clinical trial, and our training has been carried out by a number of the world’s leading experts in psilocybin therapy.”

A divide in the psychedelic community

Compass’s alleged tactics are fairly standard for the pharmaceutical industry, but unusual for the psychedelic world. Some see no problem with Compass’s business practices. Nichols, of Purdue University and the Heffter Research Institute, chalks up the criticism of Compass to resentment. “There are other groups that believed that this field should be completely not for profit and they don’t believe that anybody should start a firm that makes any money off of this treatment,” he says. Nicholas added that he doubts any nonprofit approach could meet the needs of the millions of people with conditions that could be treated by psilocybin. Doblin also says there’s considerable oversight into Compass’s trials, and that the company is working with Richards to train therapists effectively. “I don’t think they’re cavalier about it,” he says.

Still, concerns within the psychedelic community are strong enough that Bob Jesse, founder of the Council on Spiritual Practices and a Usona board member, created a “Statement on Open Science and Open Praxis with Psilocybin, MDMA, and Similar Substances,” in December 2017. “From generations of practitioners and researchers before us, we have received knowledge about these substances, their risks, and ways to use them constructively,” reads the statement. “In turn, we accept the call to use that knowledge for the common good and to share freely whatever related knowledge we may discover or develop.”

It has been signed by 104 individual scientists, scholars, and practitioners, 21 research and service organizations, including MAPS, Heffter, Usona, and 12 psychedelic societies and integration circles. Compass has not signed.

Source : https://www.msn.com/en-sg/news/techandscience/a-millionaire-couple-is-threatening-to-create-a-magic-mushroom-monopoly/ar-BBPyZNW?li=BBr8OIS

A millionaire couple is threatening to create a magic mushroom monopoly
[LIMITED STOCK!] Related eBay Products