The Federal Compassionate Investigational New Drug Study program began after Robert Randall brought a lawsuit (Randall v. U.S) against the Food and Drug Administration, theDrug Enforcement Administration, the National Institute on Drug Abuse, the Department of Justice, and the Department of Health, Education & Welfare. Randall, afflicted withglaucoma, had successfully used the Common Law doctrine of necessity to argue against charges of marijuana cultivation because it was deemed a medical necessity (U.S. v. Randall).
On November 24, 1976, federal Judge James Washington ruled:
The criminal charges against Randall were dropped, and following a petition (May 1976) filed by Randall, federal agencies began providing him with FDA-approved access to government supplies of medical marijuana, becoming the first American to receive marijuana for the treatment of a medical disorder.
Randall went public with his victory and shortly after the government tried to prevent his legal access to marijuana. This led to the 1978 lawsuit where Randall was represented pro bono publico by law firm Steptoe & Johnson. Twenty-four hours after filing the suit, the federal agencies requested an out-of-court settlement which resulted in Randall gaining prescriptive access to marijuana through a federal pharmacy near his home.
Bush administration closed the program
The settlement in Randall v. U.S. became the legal basis for the FDA’s Compassionate IND program. Initially only available to patients afflicted by marijuana-responsive disorders and orphan drugs, the concept was expanded to include HIV-positive patients in the mid-1980s.
Due to the growing number of AIDS patients throughout the late 1980s and the resulting numbers of patients who joined the Compassionate IND program, the George H. W. Bush administration closed the program down in 1992. At its peak, the program had thirty active patients.
Clinton A. Werner, author of “Medical Marijuana and the AIDS Crisis“, says that the closure of the government program during the height of the AIDS epidemic led directly to the formation of the medical cannabis movement in the United States, a movement which initially sought to provide cannabis for treating anorexia and wasting syndrome in AIDS patients.
The remaining patients in the Compassionate IND program were grandfathered in. As of 2012, there were only four surviving patients (two patients who entered the program anonymously are believed to have died). What follows is a table listing the last six patients who are not anonymous, and details of their cases.
|Name of Patient||Diagnosis||Date entered
|Years in program
(as of 7/19/12)
|Douglass, Barbara||Multiple sclerosis||August 30, 1991||9 ounces||20||Still enrolled|
|McMahon, George||Nail-patella syndrome||March 16, 1990||8 ounces||22||Still enrolled|
|Millet, Corrine||Glaucoma||November 16, 1990||4 ounces||17||Deceased (December 2007)|
|Musikka, Elvy||Glaucoma||October 17, 1988||8 ounces||23||Still enrolled|
|Randall, Robert||Glaucoma||November, 1976||24||Deceased (June 2, 2001)|
|Rosenfeld, Irvin||Rare bone disorder||November 20, 1982||9 ounces||29||Still enrolled|
* One cured ounce can equate to about 40 joints (marijuana cigarettes).
- Jump up^ Goldman, Russell (November 24, 2009). “Man Sets Marijuana Record, Smokes 115,000 Joints Provided by Federal Government”. ABC News. Retrieved December 3, 2013.
- ^ Jump up to:a b c Ben Amar M (2006). “Cannabinoids in medicine: a review of their therapeutic potential” (PDF). Journal of Ethnopharmacology (Review) 105 (1–2): 1–25. doi:10.1016/j.jep.2006.02.001. PMID 16540272.
- Jump up^ Lee, M. A. (2012). Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific. Simon and Schuster. ISBN 143912793X.
- Jump up^ The Criminal Law Reporter. 20. Bureau of National Affairs. Arlington, Va. 1976. p. 2300.
- Jump up^ Werner, Clinton A. (March 4, 2001). “Medical Marijuana and the AIDS Crisis“. J Cannabis Ther. (3/4): 17-33.
- Jump up^ “Who are the patients receiving medical marijuana through the federal government’s Compassionate IND program?”. ProCon.org. July 19, 2012. Retrieved 19 November 2012.