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Encyclopedia > Compassionate Investigational New Drug program

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. The Food and Drug Administrations Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. ... Cover of a NIDA educational booklet. ... A catalog page offering Cannabis sativa extract. ... The University of Mississippi (also known as Ole Miss) is a public, coeducational research university located near Oxford, Mississippi. ...

Contents


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: The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States. ... Since 1973, the DEA has enforced the drug laws in the United States. ... Cover of a NIDA educational booklet. ... Justice Department redirects here. ... The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ...

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 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 lead 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. Pro bono is a phrase derived from Latin meaning for the good. The complete phrase is pro bono publico, for the public good. It is used to designate legal or other professional work undertaken voluntarily and without payment, as a public service. ...


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. Human immunodeficiency virus, commonly known by the initialism HIV, formerly known as HTLV-III and lymphadenopathy-associated virus, is a retrovirus that primarily infects vital components of the human immune system such as CD4+ T cells, macrophages and dendritic cells. ... Acquired immunodeficiency syndrome, or acquired immune deficiency syndrome (or acronym AIDS or Aids), is a collection of symptoms and infections resulting from the specific damage to the immune system caused by infection with the human immunodeficiency virus (HIV). ... George Herbert Walker Bush, GCB, (born June 12, 1924) was the 41st President of the United States (1989–1993). ...


Compassionate IND today

The remaining patients in the Compassionate IND program were grandfathered in because it could entail public and embarrassing court cases for the federal government if they were to deny the patients medicine after allowing it for many years. AIDS patients who were part of the program died (prior to improvments in new AIDS life-sustaining drugs) and Randall also passed away. There are only seven surviving paitents in the program today (two remain anonymous). Irvin Rosenfeld, who joined the program in 1983, is the most public of the remaining patients and is the oldest living legal federal marijuana patient. 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. Exostosis is the formation of new bone on a the surface of a bone. ... A joint is a nicely rolled marijuana cigarette. ...


See also

A catalog page offering Cannabis sativa extract. ... Operation Mallorca, U.S. Drug Enforcement Administration, 2005 [1] The War on Drugs is an initiative undertaken in the United States to carry out an all-out offensive (as President Nixon described it) against the prohibited use of certain legally controlled drugs. ...

References


 
 

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