Medical benefits of marijuana: government hearings produce surprises

by mabone | September 23, 2008 at 12:35 pm

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First, it was smoking marijuana to reduce the nausea caused by anticancer drugs. Then, people began to discover symptom-alleviating benefits for other common conditions like chronic pain, glaucoma, and the spasticity caused by spinal cord injuries. Despite more than two decades' worth of renewed interest, personal testimony, court challenges, and recovered research to support marijuana's therapeutic efficacy, the drug continues to be viewed with great suspicion by officialdom. The illegal status of marijuana, which comes from the hemp plan cannabis sativa, makes criminal of the many American who find it provides relief not available from prescription drugs.

The therapeutic benefits of marijuana and the roadblocks to legalizing it use under medical supervision were the focus of a series of hearings conducted by the U.S. Drug Enforcement Administration. The DEA is an agency of the Department of Justice, which enforces Federal drug laws. The public hearings were part of a review ordered by the U.S. Court of Appeals after a long series of court challenges, dating back to 1972, to the government prohibition of marijuana. Over 60 witnesses, including medical experts and lay-people reporting their own experiences, testified before DEA Administrative Law Judge Francis Young between August, 1986 and September, 1988.

In a newly published book entitled Muscle Spasm, Pain & Marijuana Therapy (Washington, D.C.: Galen Press), editor R.C. Randall presents "only those portions of the court record that led Judge Francis Young to rule that marijuana has an important role to play in anti-spasmodic and pain treatments." The testimonies, albeit a one-sided selection, summarized in this book provide a powerful argument for legal access to marijuana and its use under the supervision of a physician.

One learns from the testimonies selected for this new book that many people suffering serious chronic conditions like multiple sclerosis and paralysis found relief from smoking marijuana. Many reported that they discovered the therapeutic effects accidentally while smoking marijuana for recreational reasons. Irvin Rosenfeld of North Lauderdale, Florida, who has suffered since childhood from a rare bone disease, reported an enchanced quality of pain relief and a drastic decrease in dependence upon more powerful drugs such as Dilaudid and Demerol. Thirty-nine year old Lynn Hastings of Coeur d'Alene, Idaho testified that marijuana provided substantial relief from the pain of rheumatoid arthritis, from which she has suffered most of her life. All said the benefits were superior to and far less toxic than steroids, antispastics, pain-killing narcotics, and other drugs commonly prescribed for their conditions. Several witnesses reported knowing of widespread marijuana usage among multiple sclerosis, spinal-cord injured, and cancer patients, often with the discreet approval of their physicians.

Muscle spasticity is an common problem for people with damage to the central nervous system either from diseases like cerebral palsy and multiple sclerosis or from the trauma of war wounds, falls, or car accidents. Such people, particularly those who are paraor quadriplegics, frequently suffer spontaneous muscle spasms powerful enough to throw them from their chairs. Loss of bladder control and insomnia are common. While the few prescription drugs available for the control of spasm are accepted by the medical profession as safe, they can in fact be very dangerous, reported neurologist Denis Petro, M.D. He said that people using Dantrium, or dantrolene sodium, run a very real risk of developing symptomatic hepatitis (fatal and nonfatal) and the drug's side effects commonly include weakness, fatigue, gastrointestinal bleeding, anorexia, seizure, depression, and mental confusion. Knowing this, explained Dr. Petro, doctors usually prescribe tranquilizers, muscle relaxants, mood elevators, and sedatives. These substitute drugs do not directly reduce spasticity, he said, but they weaken muscle tone making spasms less noticeable.

Dr. Petro, a former FDA medical officer, said that he became aware of the therapeutic benefits of smoking marijuana while in private practice treating people who suffered spasticity. After listening to patient after patient reporting relief and even improved bladder control, he became intrigued enought to research the topic. "Unlike many modern chemicals that have only been used in medicine for short periods of time, marijuana has a history of use in medicine that stretches back at least 5,000 years." Most important, Dr. Petro found marijuana's use in the treatment of spasticity is repeatedly mentioned by different writers living in different times and different cultures. Furthermore, there was an "immense body of medical literature developed during the late-19th and early 20th centuries on the medicinal uses of cannabis."

Why was this knowledge lost? Some noted that it occurred within the same time period as the rise of the pharmaceutical industry. But the end to the medical availability of cannabis and the decline in the level of research came with the passage of the Marijuana Tax Act of 1937, reported psychiatrist Tod H. Mikuriya, M.D. He said that from then on the prohibitionistic rhetoric of the era began to taint the medical literature with emphasis on toxicity.

His view was confirmed by Lester Grinspoon, M.D., associate professor of psychiatry at Harvard Medical School, who said that the Marijuana Tax Act was introduced under the influence of a growing concern about the use of marijuana as an intoxicant, especially among African- and Mexican-Americans in the South and Southwest. "The law passed after a strong campaign by the Federal Bureau of Narcotics, despite a lack of empirical evidence on the harmfulness of marijuana."

Dr. Grinspoon, author of Marijuana Reconsidered (Cambridge, MA: Harvard University Press, 1971), responded to statements made at the hearings by government experts. "Claims that there have been no long-term studies concerning the chronic effects of cannabis use are inaccurate. There have been several long-term studies. These studies all involved long-term heavy use of marijuana (daily use over a number of years) and found no evidence of serious adverse, physical, or psychological effects." Many witnesses, including those from the DEA, acknowledged that marijuana has never caused a death, either from chronic use or overdose.

In 1967, while a consulting researcher for the National Institute for Mental Health (NIMH), Dr. Mikuriya said he set up the first legitimate research program for the study of marijuana (using modern methods of research). He did so after an extensive review of all the medical literature available on marijuana, including the results of previous government research that had never been released.

Honest Research Inhibited

During his brief stint at the NIMH, Dr. Mikuriya reported a firsthand view of the government's bias in the way it approached the assessment of marijuana. Instead of taking a neutral stance one might expect of scientists, the government seemed bent on justifying its prohibition of marijuana as a medicine. He said that this attitude inhibited honest research and was the principle reason for his departure from the NIMH.

Dr. Petro also spoke of his difficulties trying to conduct marijuana research--after leaving the FDA to return to private practice. Without providing an explanation, the FDA refused permission to study people smoking marijuana. Instead, the study participants had to be given a synthetic substitute--in the form of a pill--of marijuana's most psychoactive component, delta-9-tetrahydrocannabinol (THC). Nine people with spasticity related to multiple sclerosis were randomly given either THC or a placebo (an inactive substance) for a study that took place at the Pennsylvania State University College of Medicine. Neither the investigators nor the participants knew who was receiving placebo.

The findings from this pilot study were not strong enough to warrant additional research, according to Dr. Petro. Significant reductions of spasticity were found in those taking THC as compared with those on the placebo. The results were published in the Journal of Clinical Pharmacology and in Psychosomatics. Unfortunately, the participants who had been smoking marijuana before the study reported that improvements from THC were not as great as those experienced by smoking marijuana.

"...the government's preference for synthetic or single compound drugs, as opposed to natural marijuana, is more based on prejudice than any other rationale. Inhaling natural marijuana is in some ways preferable as the patient is better able to control the dose through self-adjustment... A pill is a fixed dose while a cigarette can be varied to suit he needs of the patient. The inhaled dose is also preferable because the gastrointestinal tract is not involved," said Dr. Mikuriya.

In 1986, Dr. Petro filed yet another request with the FDA, this time to study cannabis in other than its synthetic form. Though he had once served as an FDA reviewer of applications for new drugs, Dr. Petro said this request was never acknowledged. He agreed with several government witnesses who stated that marijuana could never receive the required New Drug Application (NDA) approval from the FDA, "...not because marijuana is unsafe or ineffective. Indeed, the reasons marijuana cannot become an NDA-approved drug have nothing to do with science or medicine." Though there is more than enough evidence to demonstrate its safety and efficacy, Dr. Petro observed that marijuana falls though a crack in the existing regulatory scheme. The FDA's system is not designed to scientifically assess the therapeutic utility of medicinal substances, according to Dr. Petro, but to regulate the commercial marketing of drug products and to protect the public from false or misleading claims about safety and efficacy. "The combination of intensive bureaucratic oversight and fears of being labeled a 'pot doc' act as very powerful disincentives to researchers. This is particularly true in a world where there are many other drugs to study which are not so encumbered," observed John Morgan, M.D., professor of medicine and director of pharmacology at CCNY Medical School, which is part of the City University of New York.

When the hearings ended in 1988, the DEA Administrative Law Judge ruled in favor of those who wanted marijuana's classification under the Controlled Substances Act to be changed from Schedule I to Schedule II. (According to the book's glossary, Schedules I and II have basically the same definition with the exception that Schedule I drugs have "no accepted medical value in the U.S.") The new classification allows marijuana to be used under medical supervision. Concluded Judge Young: "There are those who, in all sincerity, argue that the transfer of marijuana to Schedule II will 'send a signal' that marijuana is 'OK' generally for recreational use. This argument is specious... The fear of sending such a signal cannot be permitted to override the legitimate need, amply demonstrated in this record, of countless sufferers for the relief marijuana can provide when prescribed by a physician in a legitimate case."

In a recent telephone interview, R.C. Randall, editor of Muscle Spasm, Pain & Marijuana Therapy, provided an update on what has happened since the hearings ended. "The DEA then waited 15 months and in December 1989, the DEA rejected Judge Young's decision and refused to implement his recommendations." He said that his organization, the Alliance for Cannabis Therapeutics (ACT --see page 6), was forced to go to the U.S. Court of Appeals and sue the DEA for failing to abide by the Judge's verdict. The Court took the case, and in mid-April ordered the DEA to reconsider its decision, and this is where things stand at present, according to Randall.

In the meantime, Randall said that ACT continues to help people apply to the FDA for permission to smoke marijuana through the agency's Compassionate Use Program. The process involves filling out numerous forms and, once filed, can take anywhere from two to 12 months, explained Randall. (The service costs $80--donations are accepted.) He added that he became the first person to gain legal access to marijuana in 1976, when a court ruled that his use of marijuana for glaucoma was a "medical necessity." The person who receives permission under the Compassionate Use Program is given a prescription for pre-rolled marijuana cigarettes, which is filled at a government-designated pharmacy at no cost. Randall explained that because the government has classified marijuana as "experimental," people cannot be charged for the drug.

ACT recently received funding for a special project for people with AIDS who are applying to the Compassionate Use Program. The project was formed in response to a tremendous demand from people with AIDS who have found smoking marijuana to be helpful in alleviating nausea, anorexia, and pain. Another similar special project aimed at paralyzed people was launched this month. Those who cannot afford the $80 to apply for legal access to marijuana may have their costs covered by these two projects.

MORE INFORMATION

--Read Muscle Spasm, Pain & Marijuana Therapy, edited by R.C. Randall. This 237-page paperback, published this month by Galen Press, contains the testimonies of those arguing at the DEA hearings in favor of the therapeutic use of marijuana. Research is cited throughout. Send a check for $16.95 (includes postage and handling) to Galen Press, P.O. Box 53318, Temple Heights Station, Washington, D.C. 20009 (202) 462-3080. Phone orders can be made with VISA or MasterCard.

--Contact the Alliance for Cannabis Therapeutics, P.O. Box 21210, Kalorama Station, Washington, D.C. 20009 (202) 483-8595. It is described as a "loose confederation" of patients, their relatives and physicians, medical researchers, lawyers, policy makers, and legislators. ACT will provide updates on the status of medical access to marijuana, help people apply to the FDA's Compassionate Use Program, and send out information packets on major disease categories. Staff members work without pay and the legal services are provided pro bono by the Washington, D.C. firm Steptoe and Johnson.