|Marijuana & The Migraine - Research|
Posted by FoM on October 02, 1999 at 11:52:19 PT|
For Immediate Release
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.
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.
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."
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.
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.
" 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."
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."
Tax-deductible donations to Dr. Russo's research can be made via:
2105 Robinson Avenue
or on the MAPS secure server.
For more information, contact: