Compassionate Investigational New Drug program
The Compassionate Investigational New Drug program, or Compassionate IND, is a United States Federal Government-run Investigational New Drug program established in 1978 that allows a limited number of patients to use medical marijuana grown at the University of Mississippi. It is administered by the National Institute on Drug Abuse. Closed to new entrants, there are four known surviving patients who were grandfathered into the program.
The origins of the Compassionate Investigational New Drug Study program began after Robert C. Randall brought a lawsuit (Randall v. U.S) against the Food and Drug Administration, the Drug Enforcement Administration, the National Institute on Drug Abuse, the Department of Justice, and the Department of Health, Education & Welfare. Randall, afflicted with glaucoma, 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:
While blindness was shown by competent medical testimony to be the otherwise inevitable result of the defendant's disease, no adverse effects from the smoking of marijuana have been demonstrated...Medical evidence suggests that the medical prohibition is not well-founded.
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.
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. At its peak, fifteen patients received the drug. 43 people were approved for the program, however 28 of the patients whose doctors completed the necessary paperwork never received any cannabis, including Jacki Rickert who suffers from Ehlers-Danlos syndrome and Advanced Reflex Sympathetic Dystrophy. The program stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President George H.W. Bush administration's desire to "get tough on crime and drugs." As of 2011, four patients continue to receive cannabis from the government under the program.
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 2014, 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||Status
(as of 4/18/14)
|Douglass, Barbara||Multiple sclerosis||August 30, 1991||9 ounces||25||Still enrolled|
|McMahon, George||Nail-patella syndrome||March 16, 1990||8 ounces||27||Still enrolled|
|Millet, Corrine||Glaucoma||November 16, 1990||4 ounces||17||Deceased (December 2007)|
|Musikka, Elvy||Glaucoma||October 17, 1988||8 ounces||28||Still enrolled|
|Randall, Robert||Glaucoma||November, 1976||24||Deceased (June 2, 2001)|
|Rosenfeld, Irvin||Rare bone disorder||November 20, 1982||9 ounces||34||Still enrolled|
* One cured ounce can equate to about 40 joints (marijuana cigarettes).
- Goldman, Russell (November 24, 2009). "Man Sets Marijuana Record, Smokes 115,000 Joints Provided by Federal Government". ABC News. Retrieved December 3, 2013.
- Ben Amar M (2006). "Cannabinoids in medicine: a review of their therapeutic potential" (PDF). Journal of Ethnopharmacology (Review). 105 (1–2): 1–25. PMID 16540272. doi:10.1016/j.jep.2006.02.001.
- Lee, M. A. (2012). Smoke Signals: A Social History of Marijuana - Medical, Recreational and Scientific. Simon and Schuster. ISBN 143912793X.
- The Criminal Law Reporter. 20. Bureau of National Affairs. Arlington, Va. 1976. p. 2300.
- Rupnow, Chuck (August 9, 1997). "Painful journey: Woman aims to gain support for marijuana as medicine". Eau Claire Leader-Telegram.
- Lee, Martin A. (August 2012). "Smoke Signals: A Social History of Marijuana - Medical, Recreational and Scientific, p. 234". Simon & Schuster.
- AP (September 27, 2011). "4 Americans get medical pot from the feds". Associated Press News.
- Werner, Clinton A. (March 4, 2001). "Medical Marijuana and the AIDS Crisis". J Cannabis Ther. (3/4): 17-33.
- "Who are the patients receiving medical marijuana through the federal government's Compassionate IND program?". ProCon.org. April 18, 2014. Retrieved 21 December 2015.
- Patients Out of Time, a 501(c)(3) organization whose leadership is comprised partly by the medical patients in the IND program
- Archived copy of George McMahon's website from June 2008
- Elvy Musikka's article linked to on George McMahon's website
- A cannabisnews.com news article about the 7 surviving patients
- Stalemate Over Medicinal Use of Marijuana
- DrugWarRant.com article by Pete Guither