[e-farmacos] FDA: aprueba ensayo con ectasy

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados amigos,

La FDA ha autorizado un estudio piloto con ecstasy (MDMA, metildioximetanfetamina) droga ilegal de uso recreacional) en pacientes
terminales de cancer. Su poder alucinogeno permitira un mejor manejo de los
pacientes de cancer gravemente enfermos.

La informacion esta disponible en:
http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2004/12/27/national1740EST0596.DTL
 
Un abrazo,
 
Mariano Madurga

SAN FRANCISCO CHRONICLE:
Study to gauge use of Ecstasy drug by terminal cancer patients. LOLITA C. BALDOR, Associated Press Writer

Monday, December 27, 2004

The illegal club drug Ecstasy can trigger euphoria among the dance club set,
but can it ease the debilitating anxiety that cancer patients feel as they
face their final days? 

The Food and Drug Administration has approved a pilot study looking at
whether the recreational hallucinogen can help terminally ill patients
lessen their fears, quell thoughts of suicide and make it easier for them to
deal with loved ones. 

"End of life issues are very important and are getting more and more
attention, and yet there are very few options for patients who are facing
death," Dr. John Halpern, the Harvard research psychiatrist in charge of the
study, said Monday. 

The small, four-month study is expected to begin early next spring. It will
test the drug's effects on 12 cancer patients from the Lahey Clinic Medical
Center in the Boston area. The research is being sponsored by the
Multidisciplinary Association for Psychedelic Studies, a nonprofit group
that plans to raise $250,000 to fund it. 

MAPS, on its web site, touted the study's approval, saying "the longest day
of winter has passed, and maybe so has the decades-long era of resistance to
psychedelic research." 

The FDA would not comment, but this will be the second FDA-approved study
using Ecstasy this year. South Carolina researchers are studying the effects
of Ecstasy on 20 patients suffering from post traumatic stress disorder. 

Ecstasy, known scientifically as MDMA for methylenedioxymethamphetamine, is
a chemical cousin of methamphetamine and typically induces feelings of
euphoria, increased energy and sexual arousal. But it also suppresses
appetite, thirst and the need to sleep, and in high doses can sharply
increase body temperature, leading to kidney and heart failure, and death. 

It peaked in 2001 as a trendy recreational drug used by youth at gatherings
called "raves" and dance clubs. 

Halpern, who has done other research on the effects of hallucinogenic drugs,
said that some, when used properly, can have medical benefits. He said that
unlike LSD, Ecstasy is "ego-friendly," and unlike some pain medications it
does not oversedate people and make them foggy and unsteady. 

Instead, he said, it can reduce stress and increase empathy. There are
anecdotal reports, he said, of people dying of cancer who take Ecstasy and
they are able to talk to their family and friends about death and other
subjects they couldn't broach before. 

"I'm hoping that we can find something that can be of use for people in
their remaining days of life," he said. If there are no significant
problems, he said broader studies would follow this one. 

In addition to FDA approval, the study has also received review board
authorization from the Lahey Clinic and Harvard Medical School's psychiatric
facility, McLean Hospital. Halpern is awaiting a license from the federal
Drug Enforcement Administration. 

It's been more than 40 years since Harvard has been the site of psychedelic
drug research -- including the infamous LSD studies of Timothy Leary in 1963
and the Good Friday Experiment in 1965, done by Leary's student Walter
Pahnke, studying the effects of psilocybin mushrooms on religious people. 

But "this is not about trying to create some sensationalistic storm,"
Halpern said. "This is about trying to help these patients in a meaningful
way."