Expanded access, or compassionate use, is a program in The United States, that began in the late 1970’s. It began with a provision of investigational medicine to certain patients. In 1987, a formal program was established in response to HIV/AIDS patients requesting access to drugs in development. Under Expanded Access, people with serious or life-threatening conditions, could be granted use of an investigational drug, or medical device.
The first legal Medical Cannabis patient to be registered in The United States since 1937, was Robert C. Randall. At 24, he was diagnosed with advanced glaucoma, a condition of increased pressure within the eyeball, which results in gradual loss of sight. Glaucoma is treatable, not curable. Robert C Randall noticed in his illegal Cannabis smoking, that his symptoms of glaucoma were improving. The pharmaceutical drugs he had taken for his condition, had serious adverse effects, while doing nothing to improve the problem. His MD said he’d be blind by the age of 30. The best medicine for Robert, was one that he could be incarcerated for.
In 1975, Robert and his wife Alice O’Leary Randall, were arrested for growing 4 Cannabis plants on their deck in Washington DC. They were growing their own medicine to treat Robert’s Glaucoma. At the time of arrest, Robert and Alice thought they were the only ones who knew that Cannabis may be an effective treatment for Glaucoma. They soon discovered that The US Government was also aware. Several years earlier, it was reported to Congress, but not the public.
Robert and Alice Randall fought their charges, and won with a medical necessity defense. Necessity is a defense asserted by a criminal or civil defendant that he or she had no choice but to break the law. The necessity defense has long been recognized as Common Law and has also been made part of most states’ statutory law. Although no federal statute acknowledges the defense, the Supreme Court has recognized it as part of the common law.
–Legal definition of Necessity defense
The case, United States v. Randall, was the first successful articulation of the medical necessity defense in the history of common law, and indeed, the first case to extend the necessity defense to the crimes of possession or cultivation of Cannabis.
One of the earliest expanded access programs in the US was a compassionate use IND, which allowed a limited number of people to use medical Cannabis. The Cannabis was grown at the University of Mississippi and administered by the National Institute of Drug Abuse. After The Randall’s trial, Robert won a lawsuit (Randall v. U.S), that he brought against the FDA, the Drug Enforcement Administration, the National Institute on Drug Abuse, the Department of Justice, and the Department of Health, Education & Welfare.
The settlement from that lawsuit, became the legal basis for the FDA’s compassionate IND program. The program only allowed people, with certain medical conditions, known to be alleviated with cannabis, like Glaucoma, to participate. In the late 1980’s, the program expanded to include AIDS patients. 15 people received Cannabis from the US Federal Government at the program’s peak.
A total of 43 people were approved for the program, but 28 of those people never received Cannabis, despite having their doctors complete the necessary paperwork. In 1992, the FDA’s compassionate IND program stopped accepting new people, due to public health authorities concluding there was no scientific value to it, as well George H.W. Bush administration’s policies. Currently there are 3 remaining people who still receive Cannabis from the government under this program. They are George McMahon, Irving Rosenfeld, and Elvy Musikka.
Former President, George H.W. Bush’s administration followed the precedents set by the cannabis policy of the Reagan administration, including prosecution of the War on Drugs. Bush appointed William Bennett director of the Office of National Drug Control Policy, who said in reference to cannabis, “Why in God’s name foster the use of a drug that makes you stupid?”
In 1999, the Bush administration began Operation Green Merchant, a nationwide investigation, and operation targeting businesses advertising specialized horticultural equipment that was supposedly used to grow cannabis. This program traced lists of customers who had bought such materials, and raided their homes.
In 1990, the Bush administration began another anti-Cannabis program which called for states to further punish drug offenses, including cannabis use, with a six month driver’s license suspension. States were threatened with federal highway funds being withheld if they did not comply by 1995.
It was nicknamed: ‘Smoke a joint, lose your license.’ Upon closure of the Compassionate Use IND, Director James O. Mason stated: “If it is perceived that the Public Health Service is going around giving marijuana to folks, there would be a perception that this stuff can’t be so bad.
Expanded access or compassionate use programs still exist in the United States. and even in Europe. In the US as of 2018, people could try to obtain unapproved drugs or medical devices that were in development. but under specific conditions. So why is there not a program for medical Cannabis anymore? On a federal basis, schedule 1, along with the FDA’s rules give the pharmaceutical companies favor.
The 2018 specific conditions are:
The person wanting the drug or device and a licensed physician are both willing to participate.
The person’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition.
That the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition.
The FDA determines that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance;
The FDA determines that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
The sponsor (generally the company developing the investigational product for commercial use) or the clinical investigator (or the patient’s physician in the case of a single patient expanded access request) submits a clinical protocol (a document that describes the treatment plan for the patient) that is consistent with FDA’s statute and applicable regulations for INDs or investigational device exemption applications (IDEs), describing the use of the investigational product; and
The person is unable to obtain the investigational drug or device under another IND application (for drugs), IDE application (for devices), or to participate in a clinical trials
41 states have passed right-to-try laws, as of February 2019, that permit manufacturers to provide experimental medicines to terminally ill people without US FDA authorization. It seems that both State and Federal governments have given Big Pharma exclusivity on Expanded Access or Compassionate Use programs.
Hopefully someone, in some state, (or even Europe) is looking for a loophole in their state’s right-to-try law, and will legally get another Medical Cannabis Compassionate Use program going. With Cannabis having a 10,000 year documented use history, and 0 deaths, it’s absurd that sovereign human beings must be forced through legalities to accept the less safe option of pharmaceuticals, that have a wide range of adverse effects, and claim 1 life every 19 minutes.
Written by Kerry Cannon exclusively for cannabisactivismnow.com