- 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, Grob's 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 person's
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 ñ which put out
a call in 2001 for "novel" approaches to palliative treatment
ñ largely ignored by medical science.
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- In this case, however, it has not been ignored by the
Food and Drug Administration (FDA), which holds Grob's 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 Grob's research nurse, Marycie Hagerty,
"We're basically looking for healthy dying people."
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- Psilocybin is relatively safe ñ 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, you'd
have to ingest your own body weight in "magic mushrooms" to poison
yourself. But it's 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. We're going to lose people with that."
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- According to Dr. Charles Schuster, a former director
of the National Institute of Drug Abuse, now head of Wayne State University's
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 government's
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 can't 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.)
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- 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 sufferer's need for pain medication ñ
not because it blunts pain, as morphine does, but because it "changes
one's 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."
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- 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 Boston's 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."
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- The 12 subjects ultimately recruited for Grob's study
will be alternately administered psilocybin or a placebo in two separate
sessions. The initial dose for the pilot study ñ which is primarily
to establish the safety and efficacy of the drug in advance of a broader
study sometime in the future ñ 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.
They're going to have their hands held the whole time."
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- 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 drug's 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.
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- None of this figured into the Harbor-UCLA's Institutional
Review Board assessment of Grob's study, however ñ 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 they're hard to measure in medical terms. They also
realize that the volunteer response might be small because most people
with cancer aren't looking for a better way to die. They're looking for
hope that they'll 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 didn't 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."
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- Another man called to refer his wife, who had already
been assigned to palliative care but couldn't quite accept that she was
dying. "He told us, 'She's not even thinking about death,'" says
Hagerty. "'She'll admit that she's Stage IV, but she doesn't think
she's terminal.' We heard that and changed the language, because how do
you define 'terminal'? It's 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."
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- Hagerty says that there has been no shortage of interest
in the study, just not necessarily from appropriate candidates. "We're
getting a lot of calls from people asking if we need any 'normal controls.'
Meaning they'd be happy to take the psilocybin ñ they just don't
happen to have cancer."
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- 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. "It's taken forever to get his lab work," says
Grob, "because once his doctor had determined he couldn't be cured,
his insurance wouldn't pay for new ones." Finally, his insurance provider
complied, and he's just cleared a preliminary interview with George Greer
of the Heffter Institute, the study's 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."
He'd prefer that participants don't have to travel, "but at this point
I can't be picky. I'm too anxious to get this study up and running."
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