Compassionate Investigational New Drug program
Encyclopedia
The Compassionate Investigational New Drug program, or Compassionate IND, is a United States Federal Government-ran 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.
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:
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.
* One cured ounce can equate to about 40 joints (marijuana cigarettes).
) 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.
since childhood. It is a painful disorder which causes bone tumors to form at the joint
s, 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.
Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines before a marketing application for the drug has been approved...
program that allows a limited number of patients to use medical marijuana
Medical cannabis
Medical cannabis refers to the use of parts of the herb cannabis as a physician-recommended form of medicine or herbal therapy, or to synthetic forms of specific cannabinoids such as THC as a physician-recommended form of medicine...
grown at the University of Mississippi
University of Mississippi
The University of Mississippi, also known as Ole Miss, is a public, coeducational research university located in Oxford, Mississippi. Founded in 1844, the school is composed of the main campus in Oxford, four branch campuses located in Booneville, Grenada, Tupelo, and Southaven as well as the...
. It is administered by the National Institute on Drug Abuse
National Institute on Drug Abuse
The National Institute on Drug Abuse is a United States federal-government research institute whose mission is to "lead the Nation in bringing the power of science to bear on drug abuse and addiction."-History:...
. Closed to new entrants, there are only four surviving patients who were grandfathered into the program.
Origin
Robert Randall (advocate)
Robert Randall was an advocate for medical marijuana and the founder of Alliance for Cannabis Therapeutics. He was also the first legal medical marijuana smoker in the United States. He documented his accounts in his book, co-written with wife Alice O'Leary: Marijuana Rx: The Patients Fight for...
brought a lawsuit (Randall v. U.S) against the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, the Drug Enforcement Administration
Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
, the National Institute on Drug Abuse
National Institute on Drug Abuse
The National Institute on Drug Abuse is a United States federal-government research institute whose mission is to "lead the Nation in bringing the power of science to bear on drug abuse and addiction."-History:...
, the Department of Justice
United States Department of Justice
The United States Department of Justice , is the United States federal executive department responsible for the enforcement of the law and administration of justice, equivalent to the justice or interior ministries of other countries.The Department is led by the Attorney General, who is nominated...
, and the Department of Health, Education & Welfare
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
. Randall, afflicted with glaucoma
Glaucoma
Glaucoma is an eye disorder in which the optic nerve suffers damage, permanently damaging vision in the affected eye and progressing to complete blindness if untreated. It is often, but not always, associated with increased pressure of the fluid in the eye...
, had successfully used the Common Law doctrine of necessity to argue against charges of marijuana cultivation because it was deemed a medical necessity
Medical necessity
Medical necessity is a United States legal doctrine, related to activities which may be justified as reasonable, necessary, and/or appropriate, based on evidence-based clinical standards of care. Other countries may have medical doctrines or legal rules covering broadly similar grounds...
(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
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
-positive patients in the mid-1980s. Due to the growing number of AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
patients throughout the late 1980s and the resulting numbers of patients who joined the Compassionate IND program, the George H. W. Bush
George H. W. Bush
George Herbert Walker Bush is an American politician who served as the 41st President of the United States . He had previously served as the 43rd Vice President of the United States , a congressman, an ambassador, and Director of Central Intelligence.Bush was born in Milton, Massachusetts, to...
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 IND Program |
Marijuana Dosage Per Month* |
Years in Program (through 12/31/10) |
Status (as of 4/21/10) |
| Douglass, Barbara | Multiple sclerosis Multiple sclerosis Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms... |
Aug. 30, 1991 | 9 ounces | 19 | Still Receives Med MJ |
| McMahon, George | Nail-patella syndrome Nail-patella syndrome Nail–patella syndrome is a genetic disorder that results in small, poorly developed nails and kneecaps, but can also affect many other areas of the body, such as the elbows, chest, and hips. The name "nail-patella" can be very misleading because the syndrome often affects many other areas of the... |
March 16, 1990 | 8 ounces | 20 | Still Receives Med MJ |
| Millet, Corrine | Glaucoma Glaucoma Glaucoma is an eye disorder in which the optic nerve suffers damage, permanently damaging vision in the affected eye and progressing to complete blindness if untreated. It is often, but not always, associated with increased pressure of the fluid in the eye... |
Nov.16, 1990 | 4 ounces | 17 | Deceased (12/07) |
| Musikka, Elvy | Glaucoma Glaucoma Glaucoma is an eye disorder in which the optic nerve suffers damage, permanently damaging vision in the affected eye and progressing to complete blindness if untreated. It is often, but not always, associated with increased pressure of the fluid in the eye... |
Oct. 17, 1988 | 8 ounces | 22 | Still Receives Med MJ |
| Rosenfeld, Irvin | Rare bone disorder Exostosis An exostosis is the formation of new bone on the surface of a bone. Exostoses can cause chronic pain ranging from mild to debilitatingly severe, depending on where they are located and what shape they are.... |
Nov. 20, 1982 | 9 ounces | 28 | Still Receives Med MJ |
George McMahon
George McMahon wrote a book (with author/filmmaker Christopher LargenChristopher Largen
Christopher Largen is a U.S. award-winning journalist, novelist, social satirist, actor, public speaker and filmmaker, known for his iconoclastic writings on health and public policy, and his efforts to reduce child abuse...
) 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.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 ExostosesExostosis
An exostosis is the formation of new bone on the surface of a bone. Exostoses can cause chronic pain ranging from mild to debilitatingly severe, depending on where they are located and what shape they are....
since childhood. It is a painful disorder which causes bone tumors to form at the joint
Joint
A joint is the location at which two or more bones make contact. They are constructed to allow movement and provide mechanical support, and are classified structurally and functionally.-Classification:...
s, 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.
External links
- 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