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Chronic Cannabis Use in the Compassionate Investigational New Drug Program

An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis
Russo, E., Mathre, ML., Byrne, A., Velin, R., Bach, P., Sanchez-Ramos, J., and Kirlin, KA.

Copyright 2002 by the Haworth Press: Journal of Cannabis Therapeutics, Vol. 2(1) 2002

Presented: The Second National Clinical Conference on Cannabis Therapeutics: Analgesia and Other Indications- May 3, 2002

Summary by Jay R. Cavanaugh, Ph.D.

Complete paper available online at: http://www.maps.org/mmj/russo2002.pdf

Most Americans are unaware that the United States Government has had a "compassionate use" Investigational New Drug (IND) program that has provided medical cannabis to patients for nearly 30 years. Only a handful of patients were ever approved to use NIDAís University of Mississippi grown marijuana. The government cracked open the door to medical cannabis and some 15-35 patients stepped through before the door was slammed shut. Seven of these patients are still surviving and receiving their monthly allocations of medical cannabis.

Dr. Ethan Russo and co-authors express their astonishment that virtually no research has ever been conducted or published on IND program participants. Although a small sample size, these patients represent virtually the first "official" cannabis patients. They have been provided with a mediocre but consistent supply of cannabis for chronic and serious medical conditions for a period of time ranging from 11 to 27 years in the study group.

The authors approached eight surviving IND patients. One patient, the pioneer Robert Randall, died before the study was initiated. Three others chose to remain private. The four remaining patients provided informed consent and underwent an exhaustive medical review.

The two major questions that the study dealt with are:

  1. How well has cannabis worked for the conditions prescribed?
  2. What are the nature and severity of any adverse effects of long term cannabis use?

In order to answer these questions, the authors had a variety of examinations conducted with the four study participants including:

  • MRI scan of the brain
  • Pulmonary function tests (Spirometry)
  • EEG
  • Chest X-ray (two patients)
  • Endocrine assays
  • Immunological assays
  • P300 testing (EEG Memory test) (three patients)
  • Complete battery of neuropsychological tests
  • Neurological examination
  • Records review
  • Complete history

The diagnostic procedures employed were aimed at evaluating previous claims in the literature relating to alleged adverse effects including impaired immune response, abnormal hormone levels, brain damage, memory loss, etc.

The patientís indications for adjunctive therapy with medical cannabis ranged from glaucoma to MS to Congenital Cartilaginous Exostoses to Nail-Patella Syndrome. The patients used multiple prescribed medications for their conditions along with their cannabis. The patients used approximately 7-9 grams/day of cannabis that was rated at 2.5-4.0% THC. Of major interest to AAMC and others is how this dose so closely matches that of patients in a soon to be published study of clinic patients in California. The California patients utilized 1-2 grams/day but their consistently supplied single strain is assayed at approximately 21% THC and is provided without seeds, stems, or leaf in a much fresher state than the NIDA cannabis.

Results:

Neuropsychological- "Overall, once more, no significant attributable neuropsychological sequelae are noted due to chronic cannabis usage."

Neuroimaging- "Current MRI studies on Patients A-C with a General Electric Sigma LX MR 1.5 Tesla magnet system reveal no clear abnormalities". Patient D presented MRI with the typical lesions of MS with some possible improvement over the course of cannabis therapy.

Neurophysiology- "In essence, no EEG pathology of an attributable nature seems apparent in the study group on the basis of cannabis usage."

Pulmonary- "In our patients A-C, no ultimate chest radiographic changes of significance were noted. Observed pulmonary function values in this cohort reveal no clear trends except a slight downward trend in FEV and FEV/FVC ratios." The researchers also looked at the role of low-grade NIDA cannabis as a potentially contributing factor to the modest changes in FEV and FEV/FVC. The study made a major point of addressing what the researchers called the problems with low grade, harsh medicine from NIDA.

Immunology- "All patients had CD4 counts within normal limits".

Endocrine- "None of the Patients A-D, displayed any abnormal values in any endocrine measure".

Hematological- "In our studies, Patient B, a concomitant tobacco smoker, displayed a mild degree of polycythemia and slightly elevated WBC. No other hematological changes of any type were evident in the other three patients."

Conclusions and Recommendations from paper:

CONCLUSIONS AND RECOMMENDATIONS

1. Cannabis smoking, even of a crude, low-grade product, provides effective symptomatic relief of pain, muscle spasms, and intraocular pressure elevations in selected patients failing other modes of treatment.

2. These clinical cannabis patients are able to reduce or eliminate other prescription medicines and their accompanying side effects.

3. Clinical cannabis provides an improved quality of life in these patients.

4. The side effect profile of NIDA cannabis in chronic usage suggests some mild pulmonary risk.

5. No malignant deterioration has been observed.

6. No consistent or attributable neuropsychological or neurological deterioration has been observed.

7. No endocrine, hematological or immunological sequelae have been observed.
Russo et al. 51

8. Improvements in a clinical cannabis program would include a ready and consistent supply of sterilized, potent, organically grown unfertilized female flowering top material, thoroughly cleaned of extraneous inert fibrous matter.

9. It is the authorsí opinion that the Compassionate IND program should be reopened and extended to other patients in need of clinical cannabis.

10. Failing that, local, state and federal laws might be amended to provide regulated and monitored clinical cannabis to suitable candidates"

The bottom line of looking at patients with long term histories of serious illness and use of medical cannabis is that virtually all of the patients gained significant benefit while experiencing insignificant adverse effects other than mild lung irritation due to the poor quality of their government medication.

I was able to meet and speak with three of the four patients in this study. All are now ambulatory and functional. All are bright, attentive, and function at a high level. Dr. Russo and his co-authors have done a thorough job of documenting the experience and results of these patients with what many patients described as their "life-saving" medicine.



     
   

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