Compassionate Investigational New Drug program


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The Compassionate Investigational New Drug program, or Compassionate IND, is the Investigational New Drug program allowing a limited number of patients to use National Institute on Drug Abuse-provided medical marijuana grown at the University of Mississippi. Closed to new entrants, there are only seven surviving patients who were grandfathered into the program.

Origin

The Compassionate Investigational New Drug Study program began in 1978 after a lawsuit was brought against the Food and Drug Administration, Drug Enforcement Administration, National Institute on Drug Abuse, Department of Justice, and the Department of Health, Education & Welfare by Robert Randall (Randall v. U.S). In 1976, 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 defendants 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 May, 1976 petition 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 aforementioned 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. However, because of 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 1991. At its peak, the program had thirty active patients.

Compassionate IND today

The remaining patients in the Compassionate IND program were grandfathered in. There are only seven surviving patients in the program today (two remain anonymous). What follows is a table with details of the five surviving patients who are not anonymous, and details of the case as known relating to each patient.
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  • George McMahon

    George McMahon wrote a book called "Prescription Pot" in 2004. Since 1997 he has been on a national tour, speaking of his experience as a recipient of medical marijuana. McMahon uses marijuana to relieve the pain of his disease. He had been hospitalised several times due to side effects of other drugs that he was prescribed, and found that marijuana made him as comfortable as possible without the side effects of strong prescribed medications.

    Elvy Musikka

    Elvy Musikka was born with congenital cataracts and developed glaucoma in her thirties. Surgery caused her to lose vision in her right eye. She takes marijuana to lessen the pressure on her left eye and improve her vision.

    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 cable television series. Rosenfeld has the disease Multiple Congenital Cartilaginous Exostoses, 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, but in the 30 years he has been smoking marijuana, he says, he has not had a new tumor. Irvin Rosenfeld is a successful stock broker.


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