July 28, 2020

Building an ethical startup in psychedelic medicine: an open dialogue

Written by

Lucia Huang

By: Lucia Huang and Jimmy Qian

The field of psychedelics has seen an explosion of new organizations and interests.

At Osmind, we’re building the digital infrastructure that’s needed to maximize access to these and other innovative therapies that can help where traditional treatments have failed. Our team has all had their personal stories with mental health and psychedelic healing and are devoted to improving healthcare. We want to share our startup journey, including difficult decisions we’ve faced and mistakes we’ve made, so that we can all learn from each other.

We don’t pretend we are experts in any of this; rather, we want to contribute our story to this growing field.

Some decisions we’ve faced include:

•What type of legal entity we should be (e.g. for-profit vs non-profit, C-corporation vs Public Benefit Corporation)

•Our business model — who is our “customer”; incorporating diversity and inclusion early on into our hiring practices and team formation

•Who to raise money from?; and more.

Here, we outline steps and learnings we’ve found helpful for thinking through ethics as a startup that touches the field of psychedelic medicine.

Great things on the horizon for mental health!

Understanding the psychedelics field

While we at Osmind span treatment resistant mental health more broadly, we believe psychedelics play a central role in revolutionizing mental health treatments. Our team comes from the healthcare system (with backgrounds in medicine, neuroscience biotech, digital health), and we quickly realized we needed to educate ourselves on the historical, spiritual use of psychedelics. We didn’t realize how much we had to learn, especially from those who came before us.

We learned psychedelic use could include two main perspectives:

1) The emerging medical and scientific field (perhaps even subspecialty) within psychiatry and neuroscience — from the purely medical point of view, psychedelics are an emerging treatment whose basic science mechanisms of action are yet to be fully elucidated and whose clinical evidence base is still growing.

2)The use of psychedelics for healing across millennia in religious, cultural, and healing practices. These therapies have been around for much longer than the recent interest from biomedical researchers and drug development organizations.

We realized that while the above two points can be seen as different ends of the spectrum, it's challenging to be effective without acknowledging both.

For example, someone interested in developing psychedelics as an FDA-approved medication could learn about the history of psychedelics and its use across cultures. Someone who is interested in psychedelic advocacy and holistic practice could learn about how biomedical research becomes legal medicines through the regulatory process. By understanding both perspectives, we hope that organizations can make more conscious decisions and be more inclusive.

In particular, we've learned a lot (and still have much to learn!) from experienced members of the community who have spent decades building the advocacy, legal, scientific groundwork towards accessible healing.

As some of the leaders at the Auryn Project said to us, understand that members in psychedelic medicine can only “move at the speed of trust.” At first, we felt sad and hurt that our enthusiasm to move quickly to help people could be seen as brusque. But we came to understand that members of this community may rightfully be distrustful of newcomers because of the complex histories of psychedelics, its associated histories of oppression, and the possibility of monetizing psychedelic medicine.

We can educate ourselves (e.g. resources from MAPS, Chacruna, etc.) and recognize that more experienced members don’t have any obligation to mentor us. We hope that startups can continue to be nimble to promote mental health and reduce human suffering, but recognize we should move at the speed of trust.

Work with a variety of stakeholders

Psychedelic healing has been around for a long time and many people argue that psychedelics should therefore be legal for medical and/or recreational use. These advocates often assert that if broad legalization is not achieved, patient access to transformative treatments may be limited, especially for historically marginalized populations.

In contrast, others argue that research within conventional medical institutions is the optimal path forward to achieve support from the medical and academic communities and protect against political backlash or stigmatization. To cover the massive costs of running clinical trials and getting medications FDA approved, many organizations may seek to obtain intellectual property to recoup their financial investments.

We recommend that all companies in the psychedelic medicine space seek to work with a variety of diverse stakeholders. To tackle the world’s mental health crisis and maximize healing, we need all hands on deck. If we are divisive, we lower our collective impact. We hope that organizations from legalization advocacy nonprofits to academic labs to medical providers to governmental entities to pharmaceutical companies to research institutes can all work together.

All for-profit companies should be Public Benefit Corporations

It's important to consider how for-profit entities play an important role in psychedelic medicine and how they can be held accountable to behave ethically and promote social good.

Why for-profit?

In our opinion, both nonprofit and for-profit approaches are important to make psychedelic medicine possible. In the healthcare system, industry has long been the source of new medicines and innovation; the sheer expenses (on average close to a billion dollars) of having to sponsor basic research, clinical trials, submission to the FDA, and post-market monitoring to make new medicines a possibility require some sort of financial incentive.

Oncology is an example of how industry is important within biomedicine. In the last few decades, cancer treatment has seen tremendous progress, to the point where we are close to curing certain types of cancer. Despite large amounts of government funding available for cancer, much of this success has come out of industry. In addition, an ecosystem of healthcare IT startups has sprung up to support and advance this industry, from genomic sequencing to implement more targeted therapies, to gathering valuable real world evidence to accelerate further oncology development, to liquid biopsy tests that can detect cancer early. Going forward, as psychedelic medicine runs up against barriers with clinical development, regulatory approval, insurance companies, and care delivery, it will be important to have both nonprofit and for-profit entities working side by side.

The caveat

Corporations can do a lot of damage because their mandate is to maximize shareholder value. This is further complicated in psychedelics by the dynamic between medical innovation and the history and culture of psychedelics. We believe that for-profit companies can only maximize good in mental health and psychedelic medicine if they hold themselves accountable for ethical behavior.

Promoting ethical company behavior

We think all for-profit companies in psychedelic medicine should be a Public Benefit Corporation (PBC). (Here we refer to a Delaware PBC given the vast majority of U.S. companies are incorporated in Delaware. Confusingly, there are different terminologies in different states, such as in California where a “nonprofit” is technically called a “California Public Benefit Corporation”). The most-well known PBC in psychedelics is MAPS PBC, which is wholly-owned by the nonprofit MAPS.

Why PBC?

A PBC is a type of corporation that explicitly has public benefit as a charter purpose in addition to the usual goal of creating shareholder value. The certificate of incorporation of a PBC commits the company to spending some of its profits and resources to support a specific public benefit. For example, at Osmind we have chosen to “improve patient access to innovative treatments for mental health.”

Osmind as a case study

We've faced challenging decisions in building Osmind.

We've weighed sacrificing profit to further our public benefit. We know that we can always do better to be more transparent and conscientious; we still have a lot to learn as we continue to face tough decisions so we welcome any feedback or advice. We hope that some of the decisions outlined below may be helpful conversation starters for other companies as well.

Business model

  • We've pledged that we do not and will not charge patients for anything, ever.
  • We want to further psychedelic and other innovative mental health research without imposing barriers to organizations that are not inherently profit-driven. This is not something we were clear about in our nascency and we recommend other startups think through and clearly communicate their stance on this early on.
  • We're working with academic collaborators and non-profit research organizations, whom we do not charge for our technology (except small hosting and labor fees). We provide our platform to underserved populations gratis (please reach out if you would like to engage us on this). We made a conscious choice to sacrifice profits here to help advance science and improve care delivery in this space.
  • We make money from the services we offer to providers and for-profit life sciences organizations given we provide benefit to them and they have the means to afford our services.
  • If we raise funding in the future, we want to be inclusive of non-traditional investors and find ways for community members to participate and share in any upside such as crowdfunding.

Data sharing

  • We want to give patients the power to contribute to research in this space (e.g. their de-identified information, which cannot be traced back to them or their clinic). We've consciously implemented transparent data policies beyond what’s typical or required. Beyond our Terms of Service, we implement an opt-out policy for patients who use our software. We want to empower patients and be transparent about their contributions.
  • We want to help people get better and never have to deal with treatments that don’t work ever again. We provide patients benefits in exchange for their contributions to research. We're building tools to help return useful health information to them, connect them with clinical trials for innovative treatments, and more.

Public accountability and spreading the word

The more we talk about this, the more we as companies can be aware of the ethical considerations we face. We invite startups to discuss their approaches openly. In particular, the Auryn Project and Chacruna Institute have developed guidelines and commitments for organizations in the psychedelics field:

(Please let us know if we are missing any!)

We as a community have the potential to reduce human suffering. We can all work together — from startups to research institutes to life sciences organizations — to usher in a new era of mental health care in an ethical and just way.

We would like to thank and acknowledge Shirelle Noble of the Auryn Project and others for their kindness and generosity in reviewing drafts of this piece.

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