Monday, August 8, 2011

MS Society: Support National MS Clinical Cannabis Trial

219 Woodside Ave.
Trenton, NJ 08618

August 8, 2011

National Multiple Sclerosis Society
733 Third Avenue
New York, NY 10017-3288

Dear Sir:

The National MS Society, in an Expert Opinion Paper published in 2008, acknowledged "that cannabinoids have potential...for the management of MS symptoms such as pain and spasticity" and that "there are sufficient data available to suggest that cannabinoids may have neuroprotective effects."* In 2011 the Society revised the Executive Summary of this paper. The older Executive Summary went on to say, “The Society cannot at this time recommend that medical marijuana be made widely available to people with MS for symptom management” partly because of "existing legal barriers to its use." This language no longer appears in the updated Executive Summary.

The Coalition for Medical Marijuana New Jersey (CMMNJ) is glad to see this change. CMMNJ called on the Society, in a letter dated 8/13/08, to “better serve its members by joining numerous other organizations that are calling for the legalization of medical marijuana.” CMMNJ noted that this suggestion was consistent with the actions of a number of states that have rescinded their laws prohibiting use of marijuana where medically indicated.

While the Society stopped short of endorsing medical marijuana, it dropped the statement of its opposition to widespread availability of medical marijuana for MS patients. CMMNJ urges the Society to take a more active role in advocating for large scale clinical trials of medical marijuana, so that the limits of marijuana’s therapeutic utility in symptom management and neuroprotection can be determined.

Yet the Society continues to insist that, "Studies to date do not demonstrate a clear benefit (of cannabis) compared to existing symptomatic therapies." CMMNJ wonders what other symptomatic therapy is also neuroprotective, i.e., what other therapy besides cannabis can “reduce neuronal damage and thereby…limit disease progression” as the Society’s Expert Opinion paper suggests? The Society might also wish to consider the following benefits of marijuana therapy: Marijuana can be grown at home for pennies, it is easy for patients to self-titrate, and no fatal overdoses have ever been associated with its use. These are surely clear benefits of cannabis/marijuana compared to existing therapies.

Nor should cannabinoids have to demonstrate that they are clearly superior to other therapies. No other drug is held to that standard. Cannabinoids should only have to demonstrate that they are effective and safe.

The Society is also concerned that "issues of side effects, systemic effects, and long-term effects (of cannabis) are not yet clear." Apparently, these issues are no clearer to the Society in 2011 than they were in 2008, because the language is exactly the same. CMMNJ believes that the Society is wrong when it says that the effects of marijuana are not clear. Marijuana has been in common usage in American society since the 1960’s. Millions of Americans have used and continue to use marijuana, both episodically and continuously, for over forty years. The effects are quite well known—they are mostly benign, rarely harmful, and often decidedly therapeutic. The “fears” about marijuana that the Society cites in its Expert Opinion Paper (marijuana’s possible long-term effects on cognition, motor skills, cancer, etc.) are unfounded and have been repudiated by decades of popular use, as well as scientific studies, both in America and world-wide.

Moreover, even if these fears were valid, they would have to be taken in the context of the patient population that the Society represents—patients stricken with a dreaded, incurable disease that produces pain and muscle spasms for which, the Society acknowledges, “standard therapies often provide inadequate relief.”

MS patients themselves should be the only ones who decide if the risks of engaging in clinical trials of marijuana therapy outweigh the benefits.

Over 20 years ago, on Sept. 6, 1988, Administrative Law Judge Francis L. Young, after studying the issue for two years, ruled favorably on the issue of medical marijuana. Judge Young said: "The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record."**

The Administrator of the DEA overturned Judge Young’s ruling and the DEA continues to this day to obstruct access to and research on medical marijuana.***

The Society’s Expert Opinion Paper contains a list of 14 “problems” that are associated with clinical studies of cannabis usage in MS. It is cruel of the Society to continue to insist that the “perfect” clinical research trial be designed before moving forward. In the three years between the original publication of this paper and its update, not a single new clinical trial has been noted. Apparently, not a single one of the objections raised by the Society has been addressed. This is unspeakably irresponsible, especially when given the predictable outcome of MS that is unmitigated by any neuroprotective therapy.

CMMNJ is calling on the Society to advocate for immediate access to a large scale clinical trial--a National MS Clinical Cannabis Trial. CMMNJ suggests that the federal government reopen and expand its Investigational New Drug (IND) trial of marijuana to include every patient in America with a diagnosis of MS. Every MS patient should have access to a continuous supply of marijuana, as long as these patients and their physicians agree to participate in this trial. The trial would be entirely voluntary, of course. If MS patients do not want to participate, they don’t have to. If MS patients do want to participate, however, have the federal government make marijuana continuously available to them in an amount determined to control their symptoms. Have their physician note side effects and adverse effects, clinical improvements and program withdrawals.

Have the trial computerized from the start so that periodic patient evaluations are easily entered by the clinician, and the national data seamlessly compiled. In two years there will be abundant results from this large scale clinical trial. CMMNJ predicts that evidence from this trial will be so compelling that the trial will not only be continued but expanded to include other neurological conditions as well.

The federal government--with the encouragement of the Society--must begin to facilitate large scale clinical trials, not continue to obstruct them. It is time to determine the limits of marijuana’s therapeutic potential, especially in terms of its neuroprotective capacity. CMMNJ urges the Society to strongly advocate for immediate access to a National MS Clinical Cannabis Trial. MS patients are suffering and dying now. They need and deserve this option. MS patients throughout the country would be very grateful for the opportunity to participate in this clinical trial. Thank you for your anticipated cooperation.

Sincerely yours,

Ken Wolski, RN, MPA
Executive Director, Coalition for Medical Marijuana New Jersey, Inc.

The Coalition for Medical Marijuana New Jersey, Inc. (CMMNJ) is a non-profit organization whose mission is to educate the public about the benefits of medical marijuana (cannabinoids).




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