Compassionate IND (Investigational New Drug program)
The Compassionate Investigational New Drug program, or Compassionate IND, is a United States Federal Government-run Investigational New Drug program 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 only four surviving patients who were administered into the program.
Medicinal cannabis farmed by the University of Mississippi for the government. [Since 1968, the school operates the only legal marijuana farm and production facility in the United States. The National Institute on Drug Abuse (NIDA) contracts to the university the production of cannabis for the use in approved research studies on the plant as well as for distribution to the seven surviving medical cannabis patients grandfathered into the Compassionate Investigational New Drug program (established in 1978 and canceled in 1991).]
The origins of the Compassionate Investigational New Drug Study program began in 1976 after Robert 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. 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.
Compassionate IND today
The remaining patients in the Compassionate IND program were grandfathered in. As of 2006, there were only seven surviving patients (two remain anonymous). What follows is a table listing the last five patients who are not anonymous, and details of their cases.
|Name of Patient||Diagnosis||Date Entered
|Years in Program
(as of 4/21/10)
|Douglass, Barbara||Multiple sclerosis||Aug. 30, 1991||9 ounces||19||Still Receives Med MJ|
|McMahon, George||Nail-patella syndrome||March 16, 1990||8 ounces||20||Still Receives Med MJ|
|Millet, Corrine||Glaucoma||Nov.16, 1990||4 ounces||17||Deceased (12/07)|
|Musikka, Elvy||Glaucoma||Oct. 17, 1988||8 ounces||22||Still Receives Med MJ|
|Rosenfeld, Irvin||Rare bone disorder||Nov. 20, 1982||9 ounces||28||Still Receives Med MJ|
* One cured ounce can equate to about 40 joints (marijuana cigarettes).
George McMahon wrote a book (with author/filmmaker Christopher Largen) called “Prescription Pot” in 2003. Since 1997 he has been on a national tour, speaking of his experience as a recipient of medical marijuana. McMahon uses marijuana to relieve pain, spasms and nausea related to repeated surgical and pharmaceutical maltreatment and Nail Patella Syndrome, a rare genetic condition that can cause minor to major skeletal deformities, kidney diseases, misshapen nails, and can make one more prone to glaucoma and scoliosis. He had been hospitalized several times due to side effects of other drugs he was prescribed and he found marijuana made him as comfortable as possible without the side effects of strong prescribed medications. Prior to being accepted to the federal cannabis program in 1990, McMahon had lived through 19 major surgeries, been declared clinically dead five times and was taking 17 different pharmaceutical substances daily, including 400 morphine tablets each month. Since 1990, McMahon has smoked 10 cannabis cigarettes daily. During this time he has had no surgeries or hospitalizations and he no longer uses any pharmaceutical drugs except cannabis.
Irvin Rosenfeld, who joined the program in 1983, is the most public of the remaining patients and has been using legal federal marijuana for the longest amount of time. He has been featured in numerous print articles and on the Penn & Teller: Bullshit! cable television series. Rosenfeld has had the disease Multiple Congenital Cartilaginous Exostosessince childhood. It is a painful disorder which causes bone tumors to form at the joints, stretching the surrounding tendons and veins, making movement almost impossible. Rosenfeld has had 30 tumors removed in six operations. He still has 200 tumors, some too small to remove, yet in the 30 years he has been smoking marijuana, he says, he has not had a new tumor. Irvin Rosenfeld is a successful stockbroker working and living in South Florida. He is also the author of My Medicine, a 2010 book detailing his lifetime history of medical issues, his use of cannabis to manage them, and his interactions with the legal and medical authorities.
You can find more information about him and what he does here: http://irvinrosenfeld.com
- ^ Mark Mathew Braunstein (2010). The Sixth National Clinical Conference on Cannabis Therapeutics: A Report on the 2010 Conference. Treating Yourself. “He is one of only four remaining patients whose cannabis is still provided by the federal government under its now disbanded Investigational New Drug (IND) program.”
- ^ Werner, Clinton A. (March 4, 2001). “Medical Marijuana and the AIDS Crisis“. J Cannabis Ther. (3/4): 17-33.
- ^ Irvin Rosenfeld (2010). My Medicine. Open Archive Press. ISBN 978-0-9636380-9-0. “How I Convinced the U.S. Government To Provide My Marijuana and Helped Launch a National Movement”
- Patients Out of Time, a 501(c)(3) organization whose leadership is comprised partly by the medical patients in the IND program
- George McMahon’s website
- 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