The Federal Cannabis Patients

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 that allows a limited number of patients to usemedical marijuana grown at the University of Mississippi. It is administered by the National Institute on Drug Abuse. Closed to new entrants, there are four surviving patients who were grandfathered into the program.[1]

The origins of the Compassionate Investigational New Drug Study program began after Robert Randall brought a lawsuit (Randall v. U.S)[2] 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,[2] had successfully used the Common Law doctrine of necessity to argue against charges of marijuana cultivation because it was deemed amedical 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.[3][4]

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.[2] 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, the program had thirty active patients. It 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.[5]

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.[6]

Remaining 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.[7]

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).

References:

  1. 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.
  2. 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.2006.02.001PMID 16540272.
  3. Jump up^ Lee, M. A. (2012). Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific. Simon and Schuster. ISBN 143912793X.
  4. Jump up^ The Criminal Law Reporter. 20. Bureau of National Affairs. Arlington, Va. 1976. p. 2300.
  5. Jump up^ AP (September 27, 2011). Associated Press News http://www.cbsnews.com/news/4-americans-get-medical-pot-from-the-feds/ |url= missing title (help).
  6. Jump up^ Werner, Clinton A. (March 4, 2001). “Medical Marijuana and the AIDS Crisis“. J Cannabis Ther. (3/4): 17-33.
  7. 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.

External links

Comments from Elvy Musikka, glaucoma patient and one of only eight people in the U.S. allowed to receive marijuana legally as medicine from the federal government. December 14, 1997 Hollywood, Florida

An Open Letter about Medical Marijuana

I’d like to begin by thanking so many wonderful people from all walks of life that I have met in this wonderful land of ours. Some of you were responsible for a great deal of research in the 1970’s and 1980’s. Through your efforts and with the help of patients and doctors you were able to convince 36 states of the necessity regarding marijuana as medicine. You also were able to give patients a beautiful legacy in DEA Judge Francis Young’s ruling in support of medical cannabis in 1988. As patients, we will forever be grateful to the people and all the efforts that were put into Proposition 200 and 215. The White House may still be in denial and the laws are still being challenged. But make no mistake – you ended the dark light of ignorance that lasted 60 years when you allowed to voters to speak their minds inside the voting booth.

The environmentalists have brought to our attention that we cannot live as healthy people on a sick planet. Each of these segments has contributed so much in putting together the puzzle so that the world is beginning to see the horrible spectrum that this prohibition has created. It’s tentacles strike woundingly at all the areas in our lives as patients. If you take your message on to other states, please remember that the laws that must be changed now have to be more than tokens. They have to be designed to alleviate the unnecessary horrendous suffering that is happening to millions of patients in the U.S. and the world. We must take responsibility in reminding our legislators and those practicing law enforcement that the Constitution of the U.S. is still the supreme law of this land and that all of them have taken an oath to uphold and protect this document for which so many have shed their precious blood.

In taking input from patients, you will quickly realize the intolerable situation that prevents our doctors and ourselves from communicating openly without fear of reprisals. Certainly the first amendment should apply to those who have dedicated and given up most of their youth studying so that they will know something about my body. We must at all times remember that bad laws constantly hurt good people. In the hope that we will continue to work together in order to achieve all these goals, I will close here by introducing some of you to Dr. James W. Woodward.

Dr. Woodward had worked in law policy in the U.S. since 1898, was the co-author of the Harrison Act, the first document to deal with drug illegality in our country. He was quite shocked to hear about a new drug called “marijuana” which supposedly had horrifying effects on its victims. Upon personally investigating the claims, he found not one shred of substance to the allegations. He was not allowed to testify and therefore found it necessary to write a letter which you can still find in law libraries today. In this letter, Dr. Woodward points out that if we were trying to outlaw cannabis, we shouldn’t be calling it “marijuana” (Mary Jane in Spanish). In spite of the fact that cannabis had been as widely used in the early part of this century as Tylenol is today, Dr. Woodward felt that there was still much research needed as he was convinced that this herb had many, many, more medical benefits. He stated that it’s prohibition would be a terrible disservice especially to the elderly and the children because of cannabis’ non-addictive properties. He closed the letter with genuine concern for what this prohibition would mean to the economy of the American farmer.

I support all of you. You are all desperately needed. We will all be 10 times more effective when we find the strength that can only be derived through unity.

Let’s keep learning from one another. Please keep the initiatives simple and to the point so that they can alleviate the suffering as soon as possible.

Sincerely and with love always,
Elvy Musikka