For some, the diagnosis comes out
of the blue. For others, it arrives after a long
battle. Either way, the news that death is just a
few months away poses a daunting challenge for both
doctor and patient.
Drugs can ease pain and reduce
anxiety, but what about the more profound issues
that come with impending death? The wish to resolve
lingering conflicts with family members. The longing
to know, before it's too late, what it means to
love, or what it meant to live. There is no medicine
to address such dis-ease.
Or is there?
This month, in a little-noted
administrative decision, the Food and Drug
Administration gave the green light to a Harvard
proposal to test the benefits of the illegal street
drug known as "ecstasy" in patients diagnosed with
severe anxiety related to advanced cancer.
The drug, also known as
3,4-methylenedioxymethamphetamine, or MDMA, has been
referred to by psychiatrists as an "empathogen," a
drug especially good at putting people in touch with
their emotions. Some believe it could help patients
come to terms with the biggest emotional challenge
of all: the end of life.
The FDA's approval puts the study
on track to become the first test of a psychedelic
substance since 1963 at Harvard, where drug guru
Timothy Leary lost his teaching privileges after
using students in experiments with LSD and other
hallucinogens.
It also marks a milestone for a
small but increasingly effective movement favoring a
more open-minded attitude toward the therapeutic
potential of psychedelic drugs, virtually all of
which have been criminalized and disparaged for
decades as medically useless.
Already, MDMA is being tested for
its ability to reduce symptoms of post-traumatic
stress disorder. And two U.S. studies are looking at
the usefulness of psilocybin -- the active
ingredient in "magic mushrooms" -- in terminally ill
cancer patients and in people with
obsessive-compulsive disorder.
In the coming year, advocates also
hope to submit to the FDA an application to test
psilocybin and LSD as treatments for a debilitating
syndrome known as cluster headaches.
That would be a fitting birthday
present for Albert Hofmann, the chemist who
discovered both compounds while working for the
Swiss drug company Sandoz and who turns 99 in
January, said Rick Doblin, president of the
Multidisciplinary Association for Psychedelic
Studies. The Sarasota-based nonprofit has organized
and funded much of the new research.
Hofmann, who has expressed support
for clinical studies such as the one being planned
at Harvard, has referred to LSD as his "problem
child" -- a reference to his belief that despite its
widespread abuse, the mind-altering drug has the
potential to help some people.
Although they vary in their
chemical structures and specific effects, many
psychedelic drugs work on the parts of the brain
that regulate serotonin -- the same brain chemical
that is the target of many FDA-approved
antidepressants. That does not indicate that the
drugs are necessarily safe; indeed, they all carry
some medical and psychiatric risk.
Yet even scientists who have been
vocal about those risks have expressed at least
guarded support for the idea that, in the company of
a therapist and with proper medical monitoring,
moderate doses might benefit some people.
"When taken under adverse
circumstances by ill-prepared individuals, there are
substantial psychological risks," said Charles Grob,
a psychiatrist at Harbor-UCLA Medical Center in Los
Angeles. "But when taken in the context of carefully
structured and approved research protocols and
facilitated by individuals with expertise, adverse
effects can be contained to a minimum."
Grob is leading an FDA-approved
study in which terminally ill cancer patients are
being given psilocybin to see whether it can help
them sort through emotional and spiritual issues. He
said the patients take a "modest" dose of synthetic
psilocybin, equivalent to two or three illicit
mushrooms. They spend the next six hours or so in a
comfortable setting with a psychiatrist -- talking,
thinking and sometimes listening to music with
headphones.
"So far they have had very
impressive results in terms of amelioration of
anxiety, improvement of mood, improved rapport with
close family and friends and, interestingly,
significant and lasting reductions in pain," Grob
said of the first few patients to enroll. "These are
extraordinary compounds that seem to have an uncanny
ability to reliably induce spiritual or religious
experiences when taken in the right conditions."
Promising results have also been
reported at the University of Arizona from a
10-person study of psilocybin for
obsessive-compulsive disorder, which locks people
into repetitive thoughts and actions. And
Charleston, S.C., psychiatrist Michael Mithoefer has
seen no complications in any of the five patients
who have enrolled in his 20-person study of MDMA for
victims of violence struggling with post-traumatic
stress disorder.
With the FDA's Dec. 17 approval of
the Harvard MDMA protocol -- and permission in hand
from ethics review boards at Harvard and the nearby
Lahey Clinic, where patients will be recruited --
the only remaining hurdle is getting a special
license from the Drug Enforcement Administration. A
dozen subjects with less than 12 months to live will
get either low or moderate doses of MDMA during two
sessions a few weeks apart, along with counseling
and a variety of psychological tests before and
after treatment.
The approach has its doubters.
"Even in antiquity, some groups
thought it was especially important to take whatever
their local psychedelic was -- including alcohol --
when confronting mortality, whether it's to see into
the hereafter, improve spiritual growth or just numb
yourself to the reality," said Joanne Lynn,
president of the Washington-based Americans for
Better Care of the Dying and director of RAND
Health, a science and policy research center. But
drugs can be disorienting, she said.
"It's sometimes poetic, sometimes
majestic, but often mundane work to wrap up one's
life," Lynn said. "I think it's unlikely there's a
pill that will make that go away."
John Halpern, associate director
of substance abuse research in the biological
psychiatry lab at Harvard's McLean Hospital, who
will lead the MDMA study there, agreed that it is
not for everyone. But creating a sense of connection
with something greater than oneself "may be helpful"
for many facing death, he said.
Halpern emphasized the differences
between his study and the freewheeling experiments
conducted by Leary in the 1960s.
"This is not about hippy dippy
Halpern trying to turn on the world. I'm not looking
at this as a magic bullet," he said. "But for a lot
of people, the anxiety about death is so tremendous
that there is no way to get their arms around the
problems that were ongoing in their family. This
could be a substantial contribution to the range of
palliative care strategies we're trying to develop
for people facing their death."
Laura Huxley, widow of the author
and metaphysical pioneer Aldous Huxley, said her
husband asked for -- and she provided -- a dose of
LSD as he lay dying in 1963. "He wanted to be
aware," the 93-year-old supporter of the new
research said last week. "It's a very important
moment."
Leary took a wide array of
psychedelics in the weeks leading up to his death
from cancer in 1996. Some suspect the drugs clouded
rather than sharpened his perceptions, but he died
with a positive attitude.
"It's kind of interesting really,"
he said of dying, talking to a friend in his final
days. "You should try it sometime."
Rush Limbaugh's
drug problem: (Washington Post) The tough love of
the criminal justice system is considered the
appropriate treatment for most addicts according to
our drug policy leadership. Does the policy apply to
everyone?
The Associated Press
Friday, October 10, 2003; 3:41 PM
http://www.washingtonpost.com/wp-dyn/articles/A8889-2003Oct10.html
NEW YORK -- Conservative
commentator Rush Limbaugh announced during his radio
program Friday that he is addicted to painkillers
and is checking into a rehab center to "break the
hold this highly addictive medication has on me."
"You know I have always tried to
be honest with you and open about my life," Limbaugh
said during a stunning admission aired nationwide.
"So I need to tell you today that part of what you
have heard and read is correct. I am addicted to
prescription pain medication."
"Immediately following this
broadcast, I am checking myself into a treatment
center for the next 30 days to once and for all
break the hold this highly addictive medication has
on me," he added.
Limbaugh gave up his job as an
ESPN sports analyst Oct. 1, three days after saying
on the sports network's "Sunday NFL Countdown" that
Philadelphia Eagles quarterback Donovan McNabb was
overrated because the media wanted to see a black
quarterback succeed.
The reports of possible drug abuse
surfaced at about the same time, first in the
National Enquirer. The tabloid had interviewed Wilma
Cline, who said she became Limbaugh's drug
connection after working as his maid. She said
Limbaugh had abused OxyContin and other painkillers.
Law enforcement sources who spoke
on condition of anonymity confirmed to The
Associated Press that Limbaugh was being
investigated by the Palm Beach County, Fla., state
attorney's office.
"At the present time, the
authorities are conducting an investigation, and I
have been asked to limit my public comments until
this investigation is complete," Limbaugh said
Friday.
Mike Edmondson, a spokesman for
the Palm Beach County state attorney's office, said
Friday his office could neither confirm nor deny
that an investigation was under way. Limbaugh's
attorney, Roy Black, did not return a message
seeking comment.
Limbaugh said he started taking
painkillers "some years ago" after a doctor
prescribed them following a spinal surgery. His back
pain stemming from the surgery persisted, so
Limbaugh said he started taking pills and became
hooked.
"Over the past several years I
have tried to break my dependence on pain pills and,
in fact, twice checked myself into medical
facilities in an attempt to do so. I have recently
agreed with my physician about the next steps."
fter
one of the most expensive and ribald advertising
blitzes in drug industry history, Levitra, the new
impotence treatment, has in less than a month
captured half of Viagra's market share among new
prescriptions.
The secret of Levitra's
extraordinary success is an unapologetic push for
recreational use.
Janice Lipsky, a spokeswoman for
Pfizer, which makes Viagra, said that Levitra
had benefited from "false claims and public
relations in which they inaccurately state that
Levitra works faster and is better, neither of which
is true."
GlaxoSmithKline
and
Bayer, the co-marketers of Levitra, boldly admit
that they are focusing on men who may have
successful sexual relationships but who simply want
to improve the quality or duration of their
erections.
Federal drug regulators only
started allowing widespread consumer drug
advertising in 1997, and for years the drug industry
— worried that its newfound right could be taken
away if it was seen to be abused — mostly ran
high-minded ads that sought to educate consumers
about serious diseases.
Pfizer's initial ad campaign for
Viagra, for instance, used Bob Dole as its pitchman
and educated the public about a serious condition
called erectile dysfunction, a phrase that was meant
to be a euphemism for impotence. Pfizer insisted at
the time that it was not trying to encourage
recreational use among otherwise healthy men.
Levitra's campaign has no such
high-minded purpose. The company's ads feature a
young man whose attempt to throw a football through
a tire bounces off the side. After Levitra is
mentioned, he shoots the ball through the tire again
and again and is joined by his attractive wife.
Executives at GlaxoSmithKline and Bayer are
unapologetic about their attempt to corral healthy
men into trying the drug.
Simply achieving penetration and
ejaculation — the main goals Pfizer initially set
for Viagra — are not the goals set by Levitra's
sellers. Sexual satisfaction is. "We've done a lot
of research on trying to understand what men want,"
said Nancy Bryan, vice president for marketing at
Bayer. "And what they want is to improve the quality
of their erections, to get one that's hard enough
and lasts long enough for a satisfying sexual
experience."
Data collected by ImpactRx, a
pharmaceutical promotion research company based in
Mt. Laurel, N.J., found that Levitra had captured 50
percent of the share of new prescriptions in the
erectile dysfunction market by Tuesday. New
prescriptions represent only a fraction of total
sales because they do not include refills of
existing prescriptions. The data also show that
sales representatives from GlaxoSmithKline and Bayer
are talking to doctors about Levitra 50 percent more
than sales representatives from Pfizer are speaking
about Viagra.
Ms. Lipsky said the ImpactRx data
was "grossly inconsistent with the audit data that
we use, which shows that Viagra still dominates the
category." With 11,000 sales representatives, Pfizer
generally dominates marketing among physicians in
almost every category of drugs that is important to
the company. But GlaxoSmithKline has 8,000 sales
representatives itself, and Bayer has 3,000 more.
Levitra is the most important drug introduction for
either company in years.
"We're committed to being very
competitive," Ms. Bryan said.
Tony Butler, an analyst for
Lehman Brothers, said he thought that Levitra's
fast start would soon begin to fade. Many men who
have tried Viagra have been disappointed, Mr. Butler
noted. Others have been waiting to use an impotence
drug and, with a new entrant, have decided now is
the time, he said. Levitra is capitalizing on both
sets of men.
But Levitra offers few benefits
over Viagra, Mr. Butler said, so many of those
trying Levitra may return to Viagra or will again
cease using either drug, he said. "It's way too
early to make a decision as to whether Levitra will
be preferred over Viagra," he added.
Just months away is another
competitor, Cialis from Eli Lilly, which is under
final review by the Food and Drug Administration.
Cialis is effective for 36 hours while Viagra and
Levitra work for four to five hours.
