Last updated on: 5/30/2008 | Author: ProCon.org

Who Are the Patients Receiving Medical Marijuana through the Federal Government’s Compassionate IND Program?

General Reference (not clearly pro or con)

Eight known* Compassionate Investigational New Drug (IND) patients, four of whom are still living as of Apr. 18, 2014:

Name of Patient
(in alphabetical order)
Diagnosis Date Entered
IND Program
Marijuana Dosage Per Month
(One cured ounce is about 40 cigarettes)
Status
(as of Apr. 18, 2014)
1. Douglass, Barbara Multiple Sclerosis Aug. 30, 1991 Nine cured oz (360 joints) Active program participant
2. Jenks, Barbra AIDS Feb. 19, 1991
(1st shipment)
Unknown Passed away Mar. 28, 1992
3. Jenks, Kenny AIDS Feb. 19, 1991 (1st shipment) Unknown Passed away July 19, 1993
4. McMahon, George Nail Patella Syndrome Mar. 16, 1990 Eight cured oz (320 joints) Active program participant
5. Millet, Corrine Glaucoma Nov. 16, 1990 Four cured oz (160 joints) Passed away Dec. 2007
6. Musikka, Elvy Glaucoma Oct. 17, 1988 Eight cured oz (320 joints) Active program participant
7. Randall, Robert Glaucoma Nov. 1976 Unknown Passed away June 2, 2001
8. Rosenfeld, Irvin Multiple Congenital Cartilaginous Exostoses Nov. 20, 1982 Nine cured oz (360 joints) Active program participant

*There were also two anonymous patients in the program whose names were witheld by request. These two patients are thought to have passed away based on evidence presented below, although their status cannot be confirmed due to their anonymity.

[Editor’s note: ProCon.org contacted the National Institute on Drug Abuse (NIDA) – the government organization that has supplied marijuana for the Compassionate Use IND program since it began on May 10, 1978 – several times in Mar. and Apr. 2008 to verify the status and number of patients in the program. On May 10, 2008 we received an email from NIDA Press Chief Dorie Hightower stating:

“NIDA is not in charge of this program in any way. All we do is ship mj [marijuana] to appropriately registered physicians on behalf of their patients. We have no way of knowing how many are actively receiving mj.”

ProCon.org called or emailed the US Food and Drug Administration (FDA) – the government organization that approves all IND programs – on May 12, 13, 14, 21, 28 and 29, 2008. We received an email from FDA spokeswoman Rita Chappelle on May 21, 2008 informing us they would not answer our requests for information and instructing us to call their consumer line, which we did. Katherine Chew returned our message and further declined to provide any information about the FDA’s involvement in this program. A follow up email from ProCon.org to the FDA ombudsman and drug information email address was answered on June 3, 2008 by FDA spokeswoman Crystal Rice:

“I regret that you’ve been faced with some difficulties in communicating with and receiving information from our agency. However, I must reiterate the statement made by one of my colleagues that any investigational new drug application information is proprietary and must come from the sponsor.

In regard to ‘medical’ marijuana, in general, here is our most recent agency statement: Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine.”

Read more about this federal program in our question: “What is the US government’s Compassionate Investigational New Drug (IND) program for medical marijuana?”

See videos of some of the patients on our YouTube playlist “Medical Marijuana: IND Patients.”] - Liliana Bachs, MD

The government marijuana distributed to federal IND patients
Photos by ProCon.org

The Marijuana Policy Project (MPP) wrote in a May 6, 2008 press release titled “Federal Medical Marijuana Program Marks 30th Anniversary on May 10”:

“The federal medical marijuana program — referred to as a Compassionate Investigational New Drug (IND) program — resulted from a lawsuit filed by glaucoma patient Robert Randall, who successfully showed that his use of marijuana was a medical necessity.

The program slowly grew for over a dozen years. In the wake of a flood of new applications from patients battling AIDS — who found that marijuana boosted their appetites and relieved the nausea often caused by anti-HIV drugs — the George H.W. Bush administration closed it to new applicants in March 1992, but continued supplying federal marijuana to those already receiving it. Four of those patients survive today.”

May 6, 2008 - Marijuana Policy Project (MPP)

The National Institute on Drug Abuse (NIDA) stated the following in a Jan. 1998 report titled “Provision of Marijuana and Other Compounds for Scientific Research – Recommendations of the National Institute on Drug Abuse National Advisory Council,” available on the NIDA website:

“The National Institute of Drug Abuse (NIDA) administers a contract with the University of Mississippi to grow cannabis for research purposes and is the only legal source for cannabis [marijuana] in the United States.

NIDA also supplies cannabis to seven patients under single patient so-called ‘compassionate use’ Investigational New Drug Applications (IND). In 1978, as part of a lawsuit settlement by the Department of Health and Human Services, NIDA began supplying cannabis to patients whose physicians applied for and received such an USID from the FDA. In 1992 the Secretary [of Health and Human Services] terminated this practice, but decided that NIDA should continue to supply those patients who were receiving cannabis at the time.

NIDA has overseen the farm since the institute’s inception in 1974. NIDA’s predecessor, National Institutes of Mental Health, founded a drug supply program in 1968 to provide researchers with the compounds necessary to conduct biomedical research and cannabis was among the first substances to be made available. They ‘provide a contamination-free source of cannabis material with consistent and predictable potency’ (as per NIDA, 1-98) for biomedical research.

The University of Mississippi has the option to grow either 1.5 or 6.5 acres of cannabis per year or to not grow any, depending on demand.

Generally (as of January 1998) 1.5 acres are grown in alternate years which can typically produce 50,000-60,000 cigarettes per year of three grades of potencies [strength 1: 3-4% THC; strength 2: 1.8-2.2% THC; strength 3: placebo, as close to 0% THC as possible]. Virtually all of the nearly 65,000 cigarettes produced between 1994-1996 were for single patients.

As of March 1997 there were 278,100 cigarettes in stock which are maintained in frozen storage for up to five years.”

Jan. 1998 - National Institute on Drug Abuse (NIDA)

Karen O’Keefe, JD, Assistant Director of State Policies at the Marijuana Policy Project, wrote in a Feb. 8, 2008 email to ProCon.org:

“[T]here are now only four surviving patients in the federal IND program… The patients are:

Barbara Douglass, who has MS;
George McMahon, who has Nail Patella Syndrome;
Elvy Musikka, who has Glaucoma;
Irvin Rosenfeld, who has Multiple Congenital Cartilaginous Exostoses.

In May of 2006, my coworker contacted NIDA and was told five patients were surviving at that time. We knew them to be the above four and Corrine Millet. Corrine passed away in December.”

Feb. 8, 2008 - Karen O'Keefe, JD

The US Food and Drug Administration (FDA) stated the following in an article dated Feb. 12, 2002 on its website:

“Access to unapproved drugs can occur through many legal mechanisms, including enrolling in clinical trials, a special exception or compassionate exemption, an emergency Investigational New Drug (IND), and a Treatment IND.

If the eligibility criteria in a study protocol are not suitable for a particular patient, it may still be possible to be treated according to the study protocol as a special exception (sometimes called compassionate exemption).

Treating a patient as an exception is at the discretion of the investigator and sponsor, and usually requires filing extra paperwork, including sending a request to the FDA.”

Feb. 12, 2002 - US Food and Drug Administration (FDA)

The Marijuana Policy Project’s 2002 “Medical Marijuana Briefing Paper” stated:

“In 1975, Robert Randall, who suffered from glaucoma, was arrested for cultivating his own marijuana. He won his case by using the “medical necessity defense,”, forcing the government to find a way to provide him with his medicine. As a result, the Investigational New Drug (IND) compassionate access program was established, enabling some patients to receive marijuana from the government.

In 1992, in response to a flood of new applications from AIDS patients, members of the Bush administration closed the program to all new applicants. On December 1, 1999, the U.S. Department of Health and Human Services updated its medical marijuana policy, restating that the IND program would not be reopened. Consequently, the IND program remains in operation only for the seven surviving previously approved patients.”

2002 - Marijuana Policy Project (MPP)

Al Byrne, Secretary-Treasurer and co-founder of Patients Out of Time [POT], wrote in an Apr. 1, 2008 email to ProCon.org:

“[T]he federal IND for cannabis is now at the four patient level… The four are those studied in the ‘Missoula Study’ of 2001. All are active with POT [Patients Out of Time]. The medical cannabis provided, is not of medical grade and is grown at the University of Mississippi.”

Apr. 1, 2008 - Al Byrne

Ethan Russo, MD, Senior Medical Advisor at the Cannabinoid Research Institute, wrote in his Jan. 2002 article “Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis,” (PDF 376KB) published in The Journal of Cannabis Therapeutics:

“The Missoula Chronic Clinical Cannabis Use Study was proposed to investigate the therapeutic benefits and adverse effects of prolonged use of ‘medical marijuana’ in a cohort of seriously ill patients approved through the Compassionate Investigational New Drug (IND) program of the Food and Drug Administration (FDA) for legal use of cannabis obtained from the National Institute on Drug Abuse (NIDA)… The aim [of this study] was to examine the overall health status of 8 surviving patients in the program. Four patients were able to take part, while three wished to remain anonymous, and one was too ill to participate. Unfortunately, that person, Robert Randall, succumbed to his condition during the course of the study. Thus, 7 surviving patients in the USA remain in the Compassionate IND program…

By 1991, 34 patients were enrolled in the program according to Randall (Randall and O’Leary 1998), while other sources cite the number as only 15. Facing an onslaught of new applications, the Public Health Service (PHS) in the Bush administration closed the program to new patients in March 1992…

The identities of 6 of 8 of the original Compassionate IND program subjects were known to Patients Out of Time.”

Jan. 2002 - Chronic Cannabis Use in the Compassionate IND Program Ethan Russo, MD

Robert C. Randall, a glaucoma patient who, in 1978, became the first individual granted the legal right to regularly use marijuana medically, in 1999 co-wrote with his wife Alice O’Leary the following description of the halting of the Compassionate Investigational New Drug (IND) Program for medical marijuana:

“[I]n the early 1990s when FDA [U.S. Food and Drug Administration] was compelled to expand the nation’s Compassionate IND program for medical marijuana to include HIV+ people and Americans afflicted by neurologic disorders like paralysis, multiple sclerosis, and muscular dystrophy…. federal drug agencies were whipsawed by these accelerating demands for care.

DEA [U.S. Drug Enforcement Administration] steadfastly maintained marijuana has no medical value even as FDA authorized marijuana’s compassionate medical use for the treatment of an expanding number of life- and sense-threatening diseases. By April 1991, this profound contradiction in federal policy brought the medical prohibition into crisis….

In March 1992, War on Drugs hardliners in the bureaucracy won. Bush killed FDA’s Compassionate IND program for medical marijuana. FDA dumped hundreds of Compassionate IND applications into the trash and scores of patients were arbitrarily denied promised access to medical care. Only a handful of patients — those already receiving medical marijuana — were spared.”

1999 - Robert C. Randall

George McMahon, a patient in the Compassionate IND program for medical marijuana, wrote in his 2003 book Prescription Pot (cowritten with Christopher Largen):

“I am the 5th person who has won the battle to use an illegal drug for my medical problems…I won my battle enabling me to use the illegal drug for my medical problems. I am one of only 34 known medically ill individuals who have been approved to use marijuana legally in the U.S…

Prior to getting my first legal supply of marijuana on March 17, 1990, I used marijuana illegally for more than 20 years to help cope with the pain from an illness which wasn’t diagnosed until a few years ago…

After numerous tests, evaluation and piles of legal papers, I received my first shipment of marijuana from the government’s National Institute for Drug Abuse in March of 1990. I receive 300 cigarettes per month at no cost. According to printed material provided, the cost to the government for the marijuana provided the patients is very small. I go to a designated pharmacy and through two sets of locked doors to receive my supply of marijuana, which is then stored in a locked safe, which is closer to my home…

I feel lucky to be a legal patient. I don’t feel guilty about my status, but I can’t take for granted what so many other patients need and lack. Nevertheless, my health depends on a steady supply of medicine…The elevated mood associated with cannabis definitely affected my health in a positive manner. I was more engaged with life. I took walks and rode my bike, things I never considered doing before in my depressed state, even if I had been physically capable. I ate regular meals and I slept better at night. All of these individual factos contributed to a better overall sense of well-being.”

2003 - George McMahon Christopher Largen

Elvy Musikka, a patient in the Compassionate IND program for medical marijuana, wrote in a Jan. 13, 1997 letter to then-President Bill Clinton:

“I am patient no. 3 of 8 who today currently receives medical marijuana through the federal government of the United States…

By the fall of 1990, there were five legal recipients…

By 1991, I am aware of at least 50 patients who through extensive medical records, reputable doctors, and sometimes through courts — such as in my case — were able to convince all three drug-related agencies, FDA, DEA, and NIDA, that for us, marijuana isn’t just medicine, it is the most efficient, reliable and safest part of our treatment and sometimes it is our only treatment. In the summer of 1991, the program was frozen. No new patients were given access to medical marijuana and the program was officially closed by the spring of 1992.

Unfortunately, 36 of those patients never did receive the promised marijuana from the government.”

Jan. 13, 1997 - Elvy Musikka