Investigational Compassionate New Drug program
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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 grandfathered into the program.
2 Compassionate IND today
2.1 George McMahon
2.2 Elvy Musikka
2.3 Irvin Rosenfeld
3 See also
5 External links
Medicinal cannabis farmed by the University of Mississippi for the government
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 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
IND Program Marijuana dosage
Per Month* Years in program
(through 7/19/12) Status
(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).
George McMahon 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. Elvy Musikka Elvy Musikka was born with congenital cataracts and developed glaucoma in her eyes. Surgery caused her to lose vision in her right eye. She takes marijuana to lessen the pressure on her left eye.
Elvy has spent much of her life spreading the word about the medicinal value of cannabis. She regularly attends events put on by NORML, DPA, and other drug policy reform groups. She’s been known to break into song—often on the subject of the benefits of cannabis.
Irvin Rosenfeld 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 Exostoses since 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. See also
War on Drugs
^ Mark Mathew Braunstein (2010). The Sixth National Clinical Conference on Cannabis Therapeutics: A Report on the 2010 Conference (Issue 23, 2010). 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.
^ “Who are the patients receiving medical marijuana through the federal government’s Compassionate IND program?”. ProCon.org. July 19, 2012. Retrieved 19 November 2012.
^ 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
Categories: Medicinal use of cannabisCannabis in the United States