From The Vault: THE BATTLE FOR MEDICAL MARIJUANA (1994)

Original publication: February 1994.

Thank you for reading this post, don't forget to subscribe!

THE BATTLE FOR MEDICAL MARIJUANA

PETER GORMAN

Medical marijuana is legally available to only nine people nationwide. The Compassionate Investigational New Drug (IND) program which supplies government marijuana to those nine is jointly administered by the Department of Health & Human Services (HHS), the National Institute of Drug Abuse (NIDA) and the Public Health Service (PHS)—which shut down expansion of the program two years ago, claiming that it sent a “bad signal” to the American public. But with the arrival of the Clinton team in Washington, more tolerant winds may be blowing through the corridors of power. Following an order from Secretary of Health Donna Shalala to review the Compassionate IND, rumors have been dying that the program will be opened to new applicants any day.

If the Administration does decide to reopen the program, it faces a road riddled with political and bureaucratic land mines. Keeping it shut is similarly unacceptable: people are going blind from glaucoma and suffering needlessly from the “wasting syndrome” associated with AIDS, muscular disorders, and side effects from cancer chemotherapy. Which way will the Administration turn? Difficult to say. But the story of the creation and closure of the Compassionate IND program must be looked at to grasp what is at stake.

But in the fall of 1973, Randall, a former marijuana user who hadn’t smoked since his diagnosis, smoked two joints someone had given him before going to bed one night. “When I got done,” he says, “I looked at a streetlight outside my window and noticed there were no tri-colored halos like I usually saw when the pressure in my eyes built up.” After six months of experimentation, he’d incorporated marijuana into his medical care—without telling his doctor. For the first time his disease began to come under control.

Randall began growing his own marijuana to insure a supply, and was arrested in August 1975. Shortly after his arrest he discovered that both NIDA and the Food and Drug Administration (FDA) not only had information on the use of marijuana in the treatment of glaucoma, but that NIDA grew marijuana for research on a farm at the University of Mississippi at Hattiesburg.

In December 1975, Randall underwent a 13-day controlled experiment at UCLA under the direction of Dr. Robert Hepler, to test the efficacy of marijuana in glaucoma therapy. The study concluded that left on conventional therapy, Randall would either go blind or be forced into risky surgery.

The conclusions of a second set of tests, conducted at the Wilmer Eye Institute at Johns Hopkins University in March 1976—during which he was given the highest doses of the most effective drugs used in glaucoma therapy, but no marijuana— were that Randall was a candidate for immediate surgery.

Following that test, and using the conclusions of both, in May 1976, Randall petitioned the Drug Enforcement Administration (DEA) for immediate access to medical marijuana. In November 1976, NIDA, the FDA, and the DEA jointly agreed to provide it through Dr. John Merritt at Howard University in Washington. The same test conclusions were later used in court as a “defense of medical necessity” in Randall’s criminal case. All charges against him were dismissed on November 24, 1976.

The federal government continued to supply Randall with medical marijuana until January 1978—when his supply was abruptly cut off following his refusal to stop speaking publicly about his medication. Randall launched a suit to reacquire legal medical marijuana in May. The Federal government agreed to an out-of-court settlement, and the Compassionate IND program was born.

This established a precedent by which patients, through their doctors, could be provided access to a drug prior to its approval for marketing. Randall has been receiving 300 marijuana cigarettes per month ever since as part of his medical therapy, and with the exception of the short period in early 1978 when his supply was interrupted, his glaucoma has remained stable. Though his sight is limited, he has not gone blind.

Kenny and Barbra Jenks of Panama City, FL, made a similar discovery concerning the efficacy of marijuana after contracting AIDS through a tainted blood transfusion. Kenny, a hemophiliac, found he was ill when his wife Barbra came down with pneumocystis, a form of pneumonia often found in AIDS patients, in December 1988. Both tested positive for AIDS and began AZT therapy.

One month from the time she entered the hospital, Barbra had lost 40 pounds, one-third of her body weight. Kenny didn’t begin to lose weight until the AZT therapy began, but by the end of that same month he had lost 10 pounds.

“It was impossible to eat,” he explained shortly before his death from the disease in July 1993. “And when we did, the nausea brought on by the AZT could last several hours.”

Doctors at the Bay Medical Center in Florida prescribed six medications for the nausea, but none worked. “Then we started going to an AIDS support group in Bay County, where someone told us he used pot and it took his nausea away,” said Kenny.

Though the Jenkses were nonsmokers—Kenny’d tried it a few times during high school, Barbra never had—they felt they had nothing to lose. Barbra, who has also since died, once said that the first time Kenny smoked, “he went into the refrigerator and ate everything in sight. That’s when I decided to try it as well.” During the following year she regained 35 pounds. Kenny described marijuana as effective enough to stop nausea even in the middle of a bout. “Just a few puffs and the nausea goes away.”

Like Randall, they began to grow it to provide themselves with a supply, and like Randall, they too were arrested. The Jenkses pleaded innocent on the grounds of medical necessity—but their defense was barred by the judge. They were convicted of marijuana possession, cultivation, and possession of drug paraphernalia. Judge Clinton E. Foster, recognizing their bind, sentenced them to one year’s probation and 500 hours of community service, “to be served loving and caring for each other.”

In June 1990, their doctor applied for Compassionate IND access to marijuana, and eight months later, on February 22, 1991, the Jenkses received their first shipment of legal marijuana. Later that same year the Florida Court of Appeals overturned their conviction. The reversal was upheld in Florida Supreme Court, establishing the defense of medical necessity in that state.

To Robert Randall, marijuana is a medicine, not a recreational drug. Randall says emphatically that he would be blind without it, and several studies confirm this. Kenny Jenks used to say that Barbra would not have made it through the first spring following her pneumocystis without it, and credited it with prolonging his life as well.

They are not alone. Across the country marijuana is being illegally used by thousands of afflicted people who claim it is not only safer but more effective than prescriptive medicine in treating the symptoms of numerous disorders.

Chris Woiderski of Tampa, FL is a paraplegic who uses marijuana to control his muscle spasms—which “can be as simple as one of my feet tapping, or I can have them to where I’ll be sitting and I’ll suddenly go rigid as a board.” Paralyzed from the chest down by a shooting accident in 1989, Woiderski began to experience severe muscle spasms shortly afterward. To combat the spasms, he was placed on Baclofen, Valium and Darvon, and within 10 months of the accident was taking 480 prescriptive pills per month.

But the therapy provided Woiderski little relief, and the medications’ side effects were intolerable. He was in a continual drugged state which left him incapacitated. He suffered weight loss, insomnia, severe headaches and developed a problem with his left kidney that now requires surgery.

But while undergoing treatment at the Tampa VA hospital, several paralyzed vets told Woiderski they used marijuana to control their muscle spasms. “I’d smoked occasionally, but never since the accident,” he says, “and I was skeptical. So I investigated at the local university’s medical library and found several papers dealing with marijuana’s success with spasms. So I tried it.”

He discovered that half a joint in the morning before his first transfer from bed to the wheelchair controls his spasms for about six hours. Another half a joint during the afternoon controls them for the remainder of the day, and a whole joint before bed “lets me sleep without being tossed around all night.”

Since then, Woiderski has stopped all prescriptive medication, returned to college, and helped organize Paralyzed Americans for Legal Medical Marijuana (PALM).

On November 16, 1990, Woiderski’s neurologist—who wishes to remain anonymous—applied for Compassionate IND access to marijuana. He was approved on February 16, 1991, but has never received a shipment. HHS started to phase out the Compassionate IND program in June 1991, suspending all shipments to 28 recent approvals. On March 4, 1992, the program was officially shut down for all but those 13 persons who were already receiving the government pot. The only official comment made at the time of the program’s suspension came from PHS Director Dr. James Mason. “If it’s 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,” Mason told the Washington Post on June 22, 1991. “It gives a bad signal.”

Others in the Bush administration disagreed. Shortly before Mason made his comments, Herbert D. Kleber, the deputy national drug control policy director at the Drug Czar’s office, was “touting the program on national television as a ‘compassionate’ option that was available to seriously ill patients,” according to the Washington Post report. On January 31, 1992, the Los Angeles Times reported that Ingrid Kolb, acting deputy director of the Office of Demand Reduction, another post under the Drug Czardom, “said that dozens of patients who would have been eligible for the drug ‘are suffering from great pain— many are dying.’” She recommended that marijuana be given immediately to patients approved for it.

The decision to shut down the Compassionate IND program has placed thousands of medical marijuana users in the position of having to either continue to secure their marijuana illegally or forego the therapy altogether. “I resent being criminalized because the medicine I use for an incurable disease has arbitrarily been made illegal,” says Connie Tillman, an award-winning public-access cable talk-show host, the mother of two and a multiple sclerosis sufferer who says marijuana markedly decreases her muscle spasms. Others, like Fred Cole, agree. Cole, a fishing guide from Washington state, uses marijuana for back spasms resulting from a logging injury and has spent time in jail for growing marijuana for personal medicinal use.

Before the IND program was shut down, the government had implicitly acknowledged marijuana’s utility in treatment of glaucoma, chemotherapy nausea, chronic pain, the AIDS wasting syndrome and spasm disorders. But studies and anecdotal evidence also suggest it is beneficial in treating arthritis, anorexia, head injuries, epilepsy, migraines, PMS, sickle cell anemia, and stress disorders.

But if marijuana is so effective in the symptomatic treatment of these ailments, why is it illegal as a medicine? And why was the IND program shut down?

Marijuana had been popular in a variety of tinctures until the Marijuana Tax Act of 1937 made prescriptive use of the plant obsolete. The 1937 Act was opposed by the American Medical Association’s lobbyist, Dr. William C. Woodward, but the medical industry ultimately acquiesced to the new order.

There were few protests when the 1970 Federal Controlled Substances Act placed marijuana in the Schedule I category, meaning it had no recognized medical value or applications, and could not be used even for experimental purposes.

Shortly after the Compassionate IND program was shut down, Rayford Kytle, a PHS spokesman, was quoted in the April 1, 1992 Journal of the National Cancer Institute as saying that the program was closed because the “National Institute of Health believes there are better and safer treatments than smoked marijuana for controlling chemotherapy-induced nausea, relieving eye pressure caused by glaucoma and stimulating the appetites of patients with HIV-wasting syndrome.” Kytle added that NIH scientists believe the presence of carcinogens in marijuana smoke poses a significant health hazard to AIDS and chemotherapy patients, whose immune systems are impaired. “There was concern that NIDA’s supply could not keep pace with the increasing demand,” said Kytle.

Both Kytle and PHS chief James Mason made it clear that dronabinol—a synthetic derivative of marijuana, marketed under the name Marinol—would continue to be available for chemotherapy-related nausea.

While there have been no reliable reports of marijuana smokers who do not also smoke cigarettes developing either emphysema or lung cancer, studies indicate that heavy cannabis smoking does produce some respiratory system damage. If an alternate method of delivery could be devised— aerosol spray or vaporization are frequently touted possibilities—that damage could be eliminated. But current US laws banning the production of drug paraphernalia prevent experimentation with these methods. And until new delivery systems are available, proponents feel the potential benefits of smoked marijuana outweigh the dangers. They point to more than 2,000 years of historical medicinal marijuana use worldwide with no long-term negative effects.

Many doctors agree. In a 1990 study conducted by researchers Richard Doblin and Dr. Mark Kleiman, a random, anonymous sampling of 2,430 cancer specialists from the American Society for Clinical Oncology showed 48 percent of the respondents answering that they would prescribe marijuana if it were available, and 44 percent admitted they had already recommended illegal marijuana use to at least one patient.

Kytle’s concern over marijuana’s effects on the immune system also appears unfounded. While early studies did indicate that exposure to large amounts of cannabinoids produced alterations in the immune function of lab animals and cells in vitro, no studies on humans confirmed any correlation between marijuana use and impairment of the immune function.

Kytle’s third reason for the program’s closure, concern that federal supply would not keep pace with increasing demand, might be a reason for producing a larger supply—but doesn’t warrant additional comment.

As for Marinol, it is a synthetic form of the primary active constituent of marijuana, delta-9-tetrahydracannabinol, or THC.

While some users find relief through this pill form of THC, many complain that it doesn’t work as well as marijuana, that it takes longer to begin working, and that they prefer the dosage control they have when smoking marijuana. The National Cancer Institute agreed in a 1992 factsheet titled Marijuana for Chemotherapy-Induced Nausea and Vomiting: “Research has shown that the active ingredient THC is more readily and quickly absorbed from marijuana smoke than from an oral preparation of the substance.”

Medical marijuana proponents maintain that those suffering diseases for which there are no acceptable medical alternatives should have their therapy in the hands of physicians rather than the DEA, which controls the Controlled Substances schedule.

Despite the Public Health Service’s refusal to restore the Compassionate IND program, there is increasing evidence of a change in the public’s view of marijuana as medicine. Proposition P, a medical marijuana measure, was put on the ballot in San Francisco in 1991. It passed with an overwhelming 80 percent of the vote. And in 1992, in considerably more conservative Santa Cruz County, a similar ballot initiative gained 77 percent of the vote. Since then, dozens of similar initiatives and propositions have been passed nationally. Additionally, 35 states have endorsed the use of medical marijuana—although none of them are actually distributing cannabis at this time because the federal agencies which control the supply will not provide it. During the early ’80s, state programs in California, Georgia, Michigan, New Mexico, New York and Tennessee provided nearly 800 patients medical marijuana supplied by the National Institute of Drug Abuse, but federal bureaucratic interference and expense led to their closing.

This change in the perception of marijuana as medicine is rooted in a decision by the DEA’s own Administrative Law Judge Francis L. Young, who ruled in the case of Alliance for Cannabis Therapeutics, et al, vs. US Drug Enforcement Administration, in the matter of Marijuana Medical Rescheduling Petition. In his September 1988 determination, Judge Young said: “One must reasonably conclude that there is accepted safety for use of marijuana under medical supervision. To conclude otherwise…would be unreasonable, arbitrary and capricious….”

On the question of whether the marijuana plant, as opposed to synthetics such as Marinol, should be used, Judge Young said: “The cannabis plant considered as a whole has a currently accepted medical use in treatment in the United States…and it may lawfully be transferred from Schedule I to Schedule II.” The rescheduling would have legalized medical marijuana. But the DEA, under the direction of John C. Lawn, refused to act on Judge Young’s decision.

One of the consequences of the DEA’s refusal to reschedule marijuana was that many physicians who accept marijuana’s therapeutic value began to publicly call for the right to prescribe it. On March 17, 1992, the 450-member House of Delegates of the California Medical Association voted to adopt a resolution sponsored by Berkeley psychiatrist Dr. Todd Mikuriya which, while opposing the recreational use of marijuana, stated that “the therapeutic use of cannabinoids…may be appropriate for certain conditions.” More recently, the House of Delegates for the American Medical Student Association, at their 1993 Miami conference, unanimously endorsed marijuana’s rescheduling. And this past August 26, California became the fourth state to pass a resolution urging the White House and Congress to make marijuana prescriptively available.

These changes in public awareness of medical marijuana have been reflected in court decisions as well. In October 1993, a jury acquitted 39-year-old AIDS sufferer Sam Skipper of two counts of felony marijuana cultivation despite his admission that the more than 20 plants found in his California home were his. It was the first such acquittal in US history.

Additionally, the courts have recently taken a more lenient view of caregivers—those who provide marijuana to seriously ill patients. “Brownie” Mary Rathbun, a 70-year-old from San Francisco, was arrested in July 1992 when she was caught folding two pounds of marijuana into her brownie mix for free distribution to AIDS sufferers. She faced a five-year sentence on felony charges. But all charges against her were dismissed when the local district attorney refused to prosecute. And when Oregon caregiver Sharon Place, arrested in May 1990 for growing 64 plants for free distribution to cancer, MS, and AIDS patients, was convicted of manufacture and possession of marijuana, she faced 18 months—but the judge gave her only two years’ probation and 80 hours of community service.

Whether any of these developments will hasten a rescheduling of marijuana to allow for its prescriptive use is unknown. But there is considerable optimism among medical-marijuana advocates that the election of Bill Clinton will bring a change in federal policy. Clinton’s appointment of Dr. Joycelyn Elders—who favors medical marijuana use under certain conditions—as surgeon general is a hopeful signal. Secretary of Health Donna Shalala’s order to the PHS to look into the Compassionate IND program also bodes well.

But if the decision is made to reopen the program, both Clinton and Shalala will not only have to face political heat from those who applauded the closure of the program. They’ll also have to contend with the bureaucratic question of how to provide medical marijuana to new applicants. This is a problem the PHS never had to contend with, as Compassionate IND access to marijuana was never given to more than 15 people at one time. But with awareness of marijuana’s benefits spreading rapidly through the AIDS, cancer, MS, and paraplegic communities, it is conceivable that tens, and perhaps hundreds, of thousands of people will ask their doctors to apply for the program. Providing the amount of marijuana necessary to meet those needs would require a major effort.

One short-term solution to the problem would be to have the DEA provide confiscated marijuana to the PHS for distribution, after it has been heated to eliminate potentially harmful bacteria or mold. For the long run, the government could simply plant enough to supply citizens needs until licensed private marijuana farms could be established. An alternate to those solutions would be to allow those who need medical marijuana to grow their own, or designate someone to grow it for them.

All of those solutions are political minefields: providing confiscated cannabis raises the question of quality control, since the cannabis would vary widely in potency. Using confiscated marijuana would also lead to the moral quandary of a government encouraging illegal marijuana production to ensure an adequate supply for medicine while imprisoning those who would be the suppliers. And it will be difficult to convince diehard opponents of medical marijuana to back government planting of thousands of acres of cannabis. Licensing private marijuana farms would also bring political heat. And allowing people to grow their own for medical purposes would terrify the police agencies.

But the bureaucratic concerns involved in making marijuana medically available to those who are suffering are only a distraction from the real issue. The question is not how we will solve the problem, but whether the administration is willing to make the effort to solve it. And if so, when?

It remains to be seen in which direction the administration will turn.

“IF IT’S PERCEIVED THAT THE PUBLIC HEALTH SERVICE IS GOING AROUND GIVING MARIJUANA TO PEOPLE, THERE WOULD BE A PERCEPTION THAT THIS STUFF CAN’T BE SO BAD.” —JAMES MASON, DIR. PUBLIC HEALTH SERVICE, JUNE 22, 1991

The post From The Vault: THE BATTLE FOR MEDICAL MARIJUANA (1994) first appeared on High Times.