There's a new age dawning in the mental health industry, says Pamela Hadfield, cofounder of Eastra Health, the world's first biotech company with psychedelics and women's wellness at its core.

Recreational drugs like ketamine, psilocybin and MDMA, once believed to be everything from ethically dubious to downright dangerous, are getting a second look from health practitioners and from the FDA—and the findings are shocking, that is to everyone except for longtime proponents of psychedelic therapy.

"Psychedelics are possibly one of the biggest healthcare disruptors of our generation," says Hadfield.

One study showed that MDMA-assisted therapy can virtually "cure" PTSD (i.e., wipe out its diagnostic symptoms) in 70 percent of patients, even those who were unsuccessful with traditional SSRI treatment. Another found that people with severe depressive disorder experienced significant, lasting improvement in their symptoms after just two weeks of treatment with ketamine.

Shaking up healthcare is something Hadfield knows more than a little about. Eight years ago she cofounded HelloMD, a health-tech platform centered on cannabis where visitors could obtain medical marijuana cards and source advice and information on products and treatments.

While many have found relief through cannabis, Hadfield has noticed a troubling trend over the years: Women are suffering disproportionately, and cannabis alone is often not enough.

"People started to ask me really detailed questions about psychedelics," she remembers. "It wasn't just in California, it was Suzy from Iowa asking 'how do I deal with my mental health challenges if cannabis isn't helping? Can I access MDMA? Can I access psilocybin?' It got me thinking, how can psychedelics help women?"

In June, Hadfield officially announced the launch of Eastra Health, the first psychedelic company focused specifically on women's health challenges including menopause and PMS.

"Women have been underserved and often ignored within the healthcare space," she explains. "When we look at the drugs on the market...they've been designed for men. The medical establishment has viewed women as difficult [from a clinical trials perspective] because of their hormonal cycle." Eastra—a company named for the Germanic goddess of fertility, dawn and light—will place women at its heart, from research and development to clinical trials and treatment.

There's little in Hadfield's early career that predicted her rise as a pioneer of alternative cannabis and psychedelic healthcare. More than two decades ago, she came to the Bay Area from Boston as a young art school graduate on a cross-country road trip. It was supposed to be a vacation, but Hadfield never left. Soon after, she began as a product designer at Netscape and went on to work with other Fortune 500 companies, startups, and creative agencies.

Eventually Hadfield returned to the East Coast to get an MFA in installation sculpture in New York, but California wasn't done with her yet. "I showed in museums and galleries there for a while but chose to come back to the Bay Area for the lifestyle," she says. Hadfield started a family, having three girls in four years, and caught the startup bug that led her to HelloMD.

One variety of psychedelic mushroom from the Psilocybe genus.(Courtesy of Creative Commons)

As in the early days of cannabis legalization, with Eastra, Hadfield is once again entering an uncharted frontier of the healthcare industry with a wild west mentality and a whole lot of money at play. A recent study indicated that the psychedelics industry will skyrocket in value from an estimated $2 billion dollars in 2019 to nearly $7 billion in 2026—which is an awful lot considering these drugs still remain illegal in the most of the United States.

Several companies—including Canadian-based Cybin Inc, the American Silo Pharma, and the U.K. operation Compass Pathways—have gone public in the last year and dozens of others are vying to establish themselves in an increasingly competitive field flush with investor cash. Hadfield claims that Eastra has already experienced one copycat attempt.

But even beyond the potential profits psychedelic healthcare could provide, there's good reason for the biotech frenzy: Drugs like psilocybin, MDMA, and ketamine are a desperately needed medical breakthrough in the field of mental health.

"When it comes to mental health, I would say psychiatry is floundering right now," says Erica Zelfand, an Oregon-licensed physician specializing in integrative mental health and psychedelic healing. "We've done an abysmal job of controlling the mental health epidemic, not just with women but especially with women."

In its current state, psychiatry fails miserably at addressing mental health issues in a holistic way. But psychedelics, says Zelfand, don't just treat the exterior symptoms of a problem, they treat all of our emotional, spiritual, and psychiatric needs simultaneously.

Despite the buzz around them, the use of psychedelics still faces some resistance in the U.S. While a handful of progressive places like Oakland and Oregon have decriminalized psilocybin and some other drugs, they are few and far between. The FDA is increasingly moving towards their approval, however. They've already authorized clinical trials to examine the therapeutic potential of MDMA and, two months ago, the agency gave some therapists the go-ahead to administer and study the drug in patients—a move, incidentally, that Canadian regulators made months ago. In 2019, the agency approved its first ketamine-based antidepressant.

Eastra is nearing completion of its seed round funding and Dr. Emeline Maillet, a top pharmacologist and neuroscientist in psychedelics, has just signed on as the company's chief scientific officer. Research and development comes next, a process for which they'll be using both AI and independent biotech partners for drug and molecule discovery versus running a dedicated lab of their own. Hadfield estimates this first attempt will take just three to five years.

"We are looking at an accelerated roadmap to get a mainstream psychedelic-derived drug to market," she says. Discovery will be followed with clinical trials with women in Europe and the United States.

Eastra will focus on accessible micro-dose medications—daily pills that are sub-hallucinogenic but that still provide many of the same psychedelic benefits. "The hope is that they move into being adopted by the pharmaceutical industry," explains Hadfield. "We want to go through well-established channels and typical prescribing models."

For the millions of women who get little to no relief from traditional medications like SSRIs and birth control pills for issues related to PMS and menopause, Hadfield thinks that women will naturally turn to psychedelic-derived medicines. Some who take medications developed by Eastra may not even be aware they were derived from drugs like psychedelic molecules, and that's just fine. All that matters is that "Suzy from Iowa" has access to medication which helps to solve her health challenge, says Hadfield.

"Women's biology is different, so the reality is [that] we need different treatments," she says. "We believe we've just seen the tip of the iceberg when it comes to what psychedelics may be able to address from a healthcare perspective."

// For more information, visit eastrahealth.com.