Almost as soon as Dr. Charles Grob secured approval to study the effects of psilocybin on Stage IV cancer patients, he faced another challenge, one nearly as formidable: recruiting 12 participants. Unlike so many other experiments in radical cancer treatment, Grobs does not offer a cure; he merely hopes to find that psilocybin, the most potent of the many compounds in psychedelic mushrooms, ameliorates a dying persons fear of death. The study targets patients relegated to palliative treatment, people with metastatic cancer for whom there is no reasonable hope for remission. It is a segment of the population, says the National Cancer Policy Board of the Institute of Medicine which put out a call in 2001 for novel approaches to palliative treatment largely ignored by medical science.
In this case, however, it has not been ignored by the Food and Drug Administration (FDA), which holds Grobs study to the same stringent requirements it applies to any study of any new drug. Participants in the study must have cancer of sufficient severity, but they must also be free of most other medical problems: high blood pressure, anemia, heart disease or liver dysfunction, brain tumors or metastases to the brain, kidney disease. In other words, says Grobs research nurse, Marycie Hagerty, Were basically looking for healthy dying people.
Psilocybin is relatively safe significantly safer, in fact, than the drug Grob had initially sought to use for the study, MDMA (otherwise known as Ecstasy); according to most research, youd have to ingest your own body weight in magic mushrooms to poison yourself. But its still a Schedule I drug, regarded by the federal authorities as having a high potential for abuse and no medical application. I had to get the FDA, the DEA, the IRB, the California Research Advisory Panel and our research committee here [at Harbor-UCLA] onboard, says Grob, who heads up the child-psychiatry division at Harbor-UCLA Medical Center. Along the way, the criteria we had written initially got modified and tightened. For instance, where Grob and Hagerty had specified a systolic blood-pressure reading of 160 or lower, after a great deal of discussion with the research committee here, we lowered it to 140. Were going to lose people with that.
According to Dr. Charles Schuster, a former director of the National Institute of Drug Abuse, now head of Wayne State Universitys Substance Abuse Clinical Research Division, the federal government sometimes objects to such studies out of concern not only for the patients but for the overall mood of the country. If psilocybin is shown to have some medical value, he says, that might weaken the governments argument against it as a drug of abuse. I understand their concerns and share them, but if psilocybin or MDMA or any of these agents were to prove to have a unique therapeutic value for something we cant treat well currently, ethically we have a responsibility to pursue them. (Cocaine, he notes, is used in hundreds of thousands of nasal surgeries every year.)
Grob hopes to find that, in addition to reducing psychological distress associated with impending death, psilocybin is the rare substance that can safely reduce a cancer sufferers need for pain medication not because it blunts pain, as morphine does, but because it changes ones perception of pain. He abandoned MDMA for mostly political reasons, after now-debunked research by George Ricaurte of Johns Hopkins University claimed one-time use of the drug could cause permanent brain damage. But he thinks psilocybin is better, anyway: I was concerned about the possibility of cardiac arrhythmia associated with MDMA, he says. And psilocybin might open up a deeper spiritual dimension for some people.
In 1962, a physician and minister named Walter Pahnke conducted a double-blind study with 20 Protestant divinity students, who were administered capsules containing either 30 mg of psilocybin or a placebo just before Good Friday services at Bostons Marsh Chapel. Among them was the Rev. Mike Young, now a minister at the First Unitarian Church of Honolulu, who later reported having entered a mystical state in which he lost his fear of death. As he understands it now, the drug works because human beings define their identities by this illusory thing called ego, which is constructed of memory and experience and determines who we think we are. In a controlled setting under the influence of psilocybin, you transcend that ego. And to the person who no longer identifies with that who am I, the loss of that self is no longer as threatening as it was before. The psilocybin trip was, Young recalls, a pretty profound experience.
The 12 subjects ultimately recruited for Grobs study will be alternately administered psilocybin or a placebo in two separate sessions. The initial dose for the pilot study which is primarily to establish the safety and efficacy of the drug in advance of a broader study sometime in the future is 0.2 milligrams per kilogram of synthetic, single-alkaloid psilocybin, the approved dose, says Grob. (A powerful mushroom experience would deliver about 0.3 milligrams of psilocybin per kilogram of body weight.) After each session, volunteers will be asked to evaluate their experience. Some of it may be unpleasant. Hallucinogens uncover the truth, Grob says. Sometimes the only way to get to the other side is to work through some of the darkness. Theyre going to have their hands held the whole time.
Psilocybin has been tested in a clinical context before, most recently by Dr. Francisco Moreno at the University of Arizona, who is studying its effects on the symptoms of obsessive-compulsive disorder, and Franz X. Vollenweider, who completed a dose-effect study last spring, establishing the drugs minimal risk to human health or psychological well-being. In the early 1960s, Stanislav Grof used another hallucinogen, DPT, along with LSD, to study existential anxiety in end-stage cancer patients; he found that the people he studied developed better attitudes about death, improved their relationships with family members and asked for less pain medication in the weeks and months following the experiment.
None of this figured into the Harbor-UCLA's Institutional Review Board assessment of Grobs study, however when it sent back the first draft of its official patient-consent form, it read, Benefits to Patient: None. Both Grob and Hagerty protested that there were indeed benefits, but theyre hard to measure in medical terms. They also realize that the volunteer response might be small because most people with cancer arent looking for a better way to die. Theyre looking for hope that theyll live.
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Hagerty recalls a woman who responded shortly after she and Grob first sent out the call for recruits. She was in her early 30s and had lung cancer. She had a little baby at home, and she was just desperate for anything that would help her live longer. She didnt know what psilocybin was, and I explained some of it to her and sent her to the Web site [www.canceranxiety study.org] so she could read about it. Of course, I never heard back from her.
Another man called to refer his wife, who had already been assigned to palliative care but couldnt quite accept that she was dying. He told us, Shes not even thinking about death, says Hagerty. Shell admit that shes Stage IV, but she doesnt think shes terminal. We heard that and changed the language, because how do you define terminal? Its so variable, so negative. Medical science says to the terminal patient, Go off and take care of yourself; have a nice death. But a lot of people can live with Stage IV cancer for years.
Hagerty says that there has been no shortage of interest in the study, just not necessarily from appropriate candidates. Were getting a lot of calls from people asking if we need any normal controls. Meaning theyd be happy to take the psilocybin they just dont happen to have cancer.
After two and a half months of putting out the call on e-mail lists and Web sites, Grob and Hagerty finally think they may have one participant: a man in New Mexico in the last stages of metastasized rectal cancer. Its taken forever to get his lab work, says Grob, because once his doctor had determined he couldnt be cured, his insurance wouldnt pay for new ones. Finally, his insurance provider complied, and hes just cleared a preliminary interview with George Greer of the Heffter Institute, the studys primary funder. His red-blood-cell count was right on the border, says Grob. But I got an okay from the people who run the research unit that it was good enough. Hed prefer that participants dont have to travel, but at this point I cant be picky. Im too anxious to get this study up and running.