FDA Approves
"Investigational New Drug" Application For Cannabis In Migraine Treatment.
The Narks Say We Need Research, But Now NIDA Will Stall for A Few Years.
(Marijuananews note: Dr. Russo’s research
is obviously worthwhile, but it has long been know that medical marijuana helps some
people with migraine headaches. Consequently, the most revealing thing that we may learn
from his efforts is how far the DEAland government will go to delay alleviating the
suffering of its victims, a.k.a. citizens.
Notice the absurd games that they are playing. Dr. Russo is to be admired for his
persistence.)FOR IMMEDIATE RELEASE
CONTACT: ETHAN RUSSO, MD
PRINCIPAL INVESTIGATOR
(406) 327-3372
ptm5739@montana.com
USA FOOD AND DRUG ADMINISTRATION APPROVES INVESTIGATIONAL NEW DRUG APPLICATION FOR
CANNABIS IN MIGRAINE TREATMENT
October 1, 1999
After almost three years of effort, the FDA has just granted approval to Ethan Russo,
MD, a neurologist in Missoula, Montana, to study the effects of smoked cannabis
(marijuana) as compared to oral dronabinol (Marinol®) and injected sumatriptan
(Imitrex®- the current "gold standard") in the acute treatment of migraine.
See
Government Health
Officials Deny Marijuana and Pain Study, Again -- NORML Press Release
The study will enroll 40 patients with severe migraine, and employ a double-blind,
double-dummy crossover design: neither the patients nor examiners will know whether they
are employing real cannabis or herb devoid of THC (tetrahydrocannabinol, the principal
psychoactive component), true dronabinol (synthetic THC) or placebo capsules.
Dr. Russo explains, "Cannabis has been employed for a
variety of medical indications for at least 4000 years, and there is evidence for its
effective use in migraine for 1500 years or more. It was a mainstream treatment for
migraine in Europe and the USA for a century between 1842 and 1942. It is time to test it
with modern clinical research techniques."
This is only the second clinical study of cannabis, an illegal Schedule I drug, to be
approved in the USA in the last 15 years. Dr. Donald Abrams of the University of
California is currently studying the effects of marijuana on HIV patients taking
protease-inhibitor drugs, and whether immunosuppressive effects occur with the
combination.
See
Two Year
Million Dollar Study Of How Marijuana Affects AIDS Patients Finally Begun After Five Year
Delay
Barriers to Russo's study remain. The headache trial was rejected
without review by the FDA in two previous attempts, due to a lack of a legal source of
cannabis. Russo said, "The National Institute on Drug Abuse (NIDA) holds a monopoly
on the domestic supply. They have previously required that any study employing cannabis
must obtain approval and funding through a National Institute of Health grant."
Russo's study was rejected by NIH in 1997 and 1998. Recently NIDA changed their policy,
and will now sell marijuana to researchers whose studies have gained FDA approval, but not
before they pass an additional internal Public Health Service review.
See
HHS Announcement On
New Medical Marijuana Research Rules
Shows It Is The Same Old Game.
Russo notes, "NIDA has added a new hoop through which cannabis
researchers must jump. For any other substance, even cocaine or heroin, approval of an
Investigative New Drug application by FDA allows the researcher to proceed directly to
clinical trials. NIDA has thrown up a new and unnecessary barrier to this research. Their
review panel has not been selected or seated, and there are no guarantees that members
will have any expertise in migraine treatment. NIDA has not even set the price of their
own marijuana, which is very low grade compared to the material provided by the Cannabis
Clubs in California to medical marijuana patients. Should changes be demanded by NIDA in
the protocol, we will need to start over and file a new IND application with FDA. There
will be additional unnecessary delays. In the meantime we can not properly raise funding
for the study."
Because of stringent security requirements, expensive medications and blood testing,
the Cannabis in Acute Migraine Treatment Protocol has a projected cost of $250,000.
"Good science does not come cheaply," Russo said. "Because of the steadfast
opposition of NIDA to any suggestion that cannabis has true medical utility, we are in the
position of needing to raise all expenses for the project from private sources.
This experiment is important because some 23 million Americans suffer migraine, and its
burden has an economic cost of up to $17 billion annually. At least
30% of migraineurs report ineffectiveness of modern drug treatment, while some 80% of
modern cannabis smokers who have tried it for their headaches report good relief. It is
time to test it properly.
The Institute of Medicine Report recommended that the federal government expedite
medical marijuana research, but it is apparent that NIDA remains an obstacle to its
accomplishment."
Should the current problems with NIDA continue, Dr. Russo has considered a foreign
source of supply, "The British government is fully supporting current cannabis
research. Dr. Geoffrey Guy is already recruiting multiple sclerosis patients for clinical
trials. His material is true medical grade cannabis, three to four times as potent as the
best that NIDA says that it can supply. We should be embarrassed that the USA has failed
the tests at every turn: NIDA marijuana is third rate, and yet, they still won't allow our
patients and researchers to utilize it."
See
"Feds to provide
pot for medical studies, but it’s all bunkweed." -- Cannabis Culture Reports
Dr. Guy has stated his willingness to assist Dr. Russo's project, "Subject to
obtaining appropriate clearances from the FDA for its Drug Master File and DEA [Drug
Enforcement Administration] for importation, GW Pharmaceuticals has offered to provide the
materials for this programme."
Supported