Stop the Big Pharma Takeover of Psychedelic Medicine

Stand Together for our Communities

This petition calls on our lawmakers to reject the LYKOS Corporation's application for MDMA "exclusive authorization" for three reasons:

— Exploding Costs: The LYKOS Corporation stands to be given a near decade-long monopoly to charge $25,000 or more for a treatment that insurance will never cover. The example of Australia demonstrates that these cost barriers lead to a thriving illegal market.

— Safety Oversights in the Research: There is  evidence that following the use of MDMA (3,4-methylenedioxy-methamphetamine) people are at increased risk of suicide, severe depression, and other long-term side effects. Action by the FDA will result in headlines that mislead Americans about these risks and mislead many into believing that MDMA is legal in all context. This will have deadly consequences as Americans seek MDMA on the illegal market, which presents overdoses risks since it is often cut with fentanyl and methamphetamine.

— Political Blow Back: Given the importance of this presidential election year, rushing the FDA to take action would negatively impact public debate and perception around psychedelics. Evidence from Oregon indicates this will cause a public backlash against future, deliberate progress on psychedelic reform as people feel this step is happening too fast.

Why this Matters

Every hour in our country, we lose nine of our friends and loved ones to overdose. We must now stand together to ensure that MDMA (3,4-methylenedioxy-methamphetamine) is pushed on us and controlled by the same greedy interests that created this public health emergency for profit.

Psychedelic medicines may hold some potential to help veterans, first responders, and ordinary folks work through post-traumatic stress disorder (PTSD) and alleviate addiction. But now the newly-formed LYKOS Corporation, stands to receive nearly a decade-long monopoly on access to MDMA-assisted therapy through "exclusive authorization" through the FDA.

Unfortunately, we already know the results of giving this corporation total control over this medicine. In Australia, the price of "legalized" MDMA-assisted therapy now cost over $25,000.

An Affordability Nightmare for Patients

The majority of Americans are living paycheck to paycheck, and even upper middle-class families are struggling under the weight of inflation and growing debt. At the same time, the share of Americans succumbing to treatment-resistant depression, PTSD, and related addition issues is exploding.

Enter the LYKOS Corporation, a pharmaceutical company that raised over $100 million on the news that our Food and Drug Administration (FDA} may soon grant it a monopoly on legal access to MDMA. This is despite the substance being discovered over 100 years ago in Germany and occurring naturally in San Pedro cacti that grow across the Western United States.

And unlike many pharmaceuticals, insurance would not cover MDMA treatment. In fact, MDMA will face worse coverage issues than the psychedelic Ketamine that remains far too expensive for most to access while insurers refuse to cover it. Because most Americans change private insurance plans throughout their life time, there is no incentive for insurers to cover treatments that cost in the tens of thousands of dollars as they would prefer to just pay for less for palliative medications and standard therapy.

Of course, even if some insurers did cover the treatments slated to cost $25,000 or more, insurance itself does not make healthcare affordable. Three in ten Americans cannot afford their insurance deductible in an emergency, let alone for an experimental mental health treatment.

Investor Hype Overlooks Long-Term Risks of MDMA

While our organizations Bay Staters for Natural Medicine, New England Vets for Plant Medicine, and Parents for Plant Medicine have long advocated for greater acceptance of psychedelics as a tool for healing, we believe there are important side-effects to MDMA (3,4-methylenedioxy-N-methylamphetamine) that are being overlooked by the profit-driven company.

It is widely acknowledged that MDMA use can lead to severe bouts of depression after use, as users' brains are depleted of serotonin after being exposed to abnormally high levels during the experience.  To quote a study in the Journal of Psychoactive Drugs, "MDMA administration is followed by a period of neurochemical recovery, when low serotonin levels are often accompanied by lethargy and depression. Regular usage can also lead to serotonergic neurotoxicity, memory problems, and other psychobiological problems."

Any move by the FDA to approve LYKOS will cause the underground distribution of MDMA to explode in prevalence with uncertain health consequences. There is a critical shortage of therapists trained to administer MDMA in clinical settings and the price point of $25,000 (+) is out of reach for even upper middle class people in the United States. This means that headlines that "MDMA is legal" will generate cultural interest without any realistic infrastructure to get people this substance in a safe setting. Add to this the reality that MDMA is often cut with dangerous additives like fentanyl and methamphetamine and the consequences of that decision becomes a fatal one.

Nationwide Political Backlash

It is no secret that the United States is extremely polarized. The presidential election between President Biden, former President Trump, and Robert Kennedy will only intensify political tensions going into this summer. If the FDA gives the LYKOS Corporation this monopoly to "legalize" MDMA this August, it is likely to cause a nationwide panic that psychedelic policy is evolving too quickly at a time when Americans are increasingly retreating into partisan divides.

Oregon demonstrates this backlash effect. In 2020, a ballot question "legalized" psychedelic mushrooms for use at highly controlled service centers. Far from giving a boost to political perception of psychedelics, the legalization caused an incredible backlash as seven in ten Oregon counties went back and voted to ban psychedelic service centers. Much like the would-be scenario with the LYKOS Corporation, a treatment with psilocybin services in Oregon costs almost $3,500 or more.

Ultimately, these high prices mean that virtually no one would be closer to benefiting from psychedelics. Instead, it will simply become yet another political football to toss around in a highly-charged political atmosphere, potentially spelling doom for all of the local work decriminalizing natural psychedelics going on around the country.

Sponsored by