The mother of two was diagnosed with stage 4 breast cancer in March 2020 and knew she wanted to seek treatment for more than the cancer itself. The emotional anguish that comes with a terminal diagnosis was something she wanted addressed. She began looking at various therapies that could help her make sense of everything and find peace.
A doctor from the AIMS Institute suggested that she could benefit from therapy with the main psychoactive ingredient in magic mushrooms. Baldeschwiler had only taken mushrooms recreationally a couple times in her early 20s, but she was interested in the therapeutic use of the drug.
There was a problem. The treatment of depression and anxiety in patients with life-threatening cancer has been shown to work, but it has not been approved by the FDA for any purpose. It is a Schedule I substance in the United States.
The Right to Try Act allows people with life threatening illnesses to try drugs that have made it past phase 1 clinical trials. Right to Try has been enacted at the state level in 41 states.
A number of cancer patients have used Right to Try to access drugs. She is one of the first cancer patients to try to use the law for treatment with a Schedule I drug. Aggarwal had to get permission from the Drug Enforcement Administration to administer the drug.
There is nothing in state or federal law that excludes scheduled drugs from the Right to Try Act, so it should have been easy for the Drug Enforcement Administration to grant permission to give the drug to a cancer patient. It turned out to be something else.
After first reaching out to the Drug Enforcement Administration, Baldeschwiler is stuck in a frustrating holding pattern. The lawsuit was dismissed due to a technicality. The agency hasn't yet made a final decision that will allow Baldeschwiler and Bloom to access therapy.
The administrator of the Drug Enforcement Agency didn't respond to interview requests. In an e-mail to Scientific American, the spokesman for the Drug Enforcement Administration said they would decline the opportunity.
Knowing there are substances out there that can help but that they are being taken off the table by some third-party agency is the most frustrating part of the experience.
All but the most determined investigators were prevented from conducting research on the medical use of Schedule I drugs because of political vilification for the past forty years. In the past few years, there has been a huge increase in support for the drug. Studies show that banned substances can be safely administered and have medical value, including for difficult-to-treat conditions such as severe post-traumatic stress disorder.
According to some researchers, mind- altering drugs have a long history of easing the death process. The ancient practice of using these medicines to help with major life transitions is still being practiced today.
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In the early 1960s, Eric Kast, an assistant professor of medicine and psychiatry at the Chicago Medical School, tested the effects of lysergic acid diethylamide on cancer patients. Patients were able to take the drug for up to two weeks after using it.
There was a side effect that seemed to offer some relief from the distress of terminal illness. In 1964, he wrote, "These patients displayed a peculiar disregard for the gravity of their situation, and talked freely about their impending death with an affect considered inappropriate in our western civilization, but most beneficial to their own psychic states."
In the 70s, studies on mysticism were stopped. More than 200 cancer patients received treatment with the drug. The time before a person's death was said to have been transformed by it. The psychological suffering was mitigated.
Around a decade ago, scientists were able to return to this promising line of investigation after a long time. They began working their way through clinical trials to find a cure for a variety of conditions. Safety in humans is the first phase of a clinical trial, followed by test safety and efficacy. A double-blind Phase I study was published in 2011. The 2016 study involved 51 cancer patients. The studies found that the benefits lasted weeks or even months after a single active treatment session.
According to Johnson, the sense of unfairness, punishment, helplessness and uncertainty is particularly extreme with cancer. A lot of people are helped by it.
Johnson is not aware of any studies currently being conducted using psychedelics to treat cancer distress. The need is there. Johnson has lost count of the number of patients and family members who have reached out to him in the hopes of finding a cure for their condition. He says it is in the hundreds of calls with cancer. I think it is heartbreaking.
She used ketamine therapy to get psychological relief from her diagnosis. Both she and the therapist agreed that she could benefit from a more potent treatment. There was still distress that needed to be addressed. There was more that we could offer her.
With the help of Tucker and Aggarwal, they were able to navigate the legal aspects of the therapy. Tucker contacted the Drug Enforcement Administration in January 2021. She says that it became apparent that the Drug Enforcement Agency didn't know how to use Right to Try laws.
Tucker says that the request was denied by the Drug Enforcement Administration. The administration has no authority to waive any of the requirements of theControlled Substances Act according to the letter written by Thomas Prevoznik. Prevoznik didn't reply to interview requests.
The Right to Try Act is an amendment to the 1938 Federal Food, Drug and Cosmetic Act, however, and the 1970 Controlled Substances Act has a provision clarifying that nothing in its text supersedes the FDCA. According to Tucker, legal analysis would conclude that the Right to Try Act should not be impeded by the Drug Enforcement Administration.
The lawsuit was filed in the US Court of Appeals for the Ninth Circuit. She says that the decision outlined in the two-page letter sent to Tucker was not enough to allow for judicial review. The suit was thrown out by a three judge panel.
There was a final decision to be made by the Drug Enforcement Agency in January 2022. Delay is the name of the game for the Drug Enforcement Agency. Patients with terminal illnesses don't have the time for the Drug Enforcement Agency to stand there and do nothing.
She reached out to Senator Murray of Washington State to ask for her assistance. One of the 17 people arrested for refusing to leave the headquarters of the Drug Enforcement Administration was a demonstrator.
A possible religious exemption is one of the options that Aggarwal is looking into as the delays continue. Underground psilocybin-assisted therapy is still illegal for those who have the funds. Baldeschwiler wouldn't say if she's been able to access the therapy or if she's planning on doing so.
It could benefit other people with life threatening illnesses or conditions who wish to seek relief through therapy with drugs currently being investigated in clinical trials.
She believes in the importance of giving patients the right to make their own healthcare decisions and will continue to pursue her rights under the law. When cancer takes over your body, you have no choice but to choose. It's my way of being of service.
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