F or several decades, researchers have sought to determine whether marijuana has legitimate medical uses, and narcotics control agencies have discouraged them from finding out. Now a new round of federally funded research may provide some answers-or will it? The latest skirmish between scientists and police comes on the heels of two popular referenda, in California and Arizona, legalizing the medical use of marijuana. But since it remains a federal crime to grow, sell, or prescribe cannabis, the referenda have created only a legal morass.
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Barry McCaffrey, director of the White House Office of National Drug Control Policy, derided the propositions as "hoax referendums," and insisted that voters had been "duped" by deceitful ad campaigns whose real intent was to legalize drugs. Attorney General Janet Reno announced that prescribing or recommending marijuana was still a violation of federal law, and that any doctors who did so could be prosecuted and lose their license to prescribe all drugs regulated by the Drug Enforcement Administration (DEA).
However, the medical use of marijuana has been gaining respectability. Several states have research programs of their own and some governors, including Republican William Weld of Massachusetts, openly endorse medical legalization. The editor of the prestigious New England Journal of Medicine, Jerome Kassirer, lambasted the Clinton administration in an editorial entitled "Federal Foolishness and Marijuana" that received national attention. "To prohibit physicians from alleviating suffering by prescribing marijuana for seriously ill patients," Kassirer wrote, "is misguided, heavy-handed, and inhumane."
In January, Director McCaffrey, finding himself knee-deep in a debate in which he was little qualified to participate, tried to defuse criticism with an announcement that the Institute of Medicine (IOM) would be given $1 million to conduct an 18-month review of the current literature on marijuana. Later that month Harold Varmus, director of the National Institutes of Health (NIH), announced that the NIH would convene a workshop on the medical utility of marijuana. "We have no rationale for not looking into it," Dr. Varmus said in a phone interview.
But the IOM conducted a similar study back in 1982 and issued a report entitled "Marijuana and Health," concluding that "Marijuana and its derivatives or analogues might be useful in the treatment of glaucoma, of nausea and vomiting brought on by cancer chemotherapy, and of asthma. . . ." A review of the existing literature, as Kassirer pointed out, will likely be inconclusive because no definitive study has been done. The new IOM review, Kassirer said in an interview, "was a political maneuver designed to move the debate off center stage-it probably could be done in 18 days."
In February, the NIH held its workshop, organized by the National Institute on Drug Abuse (NIDA), and workshop participants initially promised to submit their recommendations for further research to Varmus by the end of March. But as this article goes to press in mid-June, three months have passed and the recommendations have yet to be submitted.
E ver since the 1930s and the era of "Reefer Madness," when marijuana acquired both a countercultural stigma and allure, the federal government has resisted attempts to legalize marijuana for medical purposes-both by inhibiting research and by restricting access to the drug. The government has been fearful of sending the message that if marijuana is medically useful, it also can be used safely as a recreational drug. The scientific issue is unresolved, but nonetheless closed.
The medical marijuana movement emerged with the rise of recreational marijuana use in the 1960s. Marijuana had long been known to promote appetite, and a few studies in the first half of the twentieth century showed that it aided in alleviating nausea. Many chemotherapy patients found that smoking marijuana not only relieved their nausea and vomiting better than any of the legally available medications, but also enhanced appetite and relieved anxiety. For many, the relief from smoking pot was so strikingly better than from the use of Compazine, the anti-nauseant of choice, that word quickly spread among patients and doctors and then on to legislators.
In a 1980 congressional hearing titled "Health Consequences of Marijuana Abuse: Recent Findings and the Therapeutic Uses of Marijuana and the Use of Heroin to Reduce Pain," two prominent oncologists-Steven Sallan, then clinical director of pediatric oncology at the Sidney Farber Cancer Institute, and Solomon Garb, president of the medical staff at the AMC Cancer Research Center in Lakewood, Colorado-and others attested to the medical utility of both smokable marijuana and its primary active ingredient, delta-9-THC. They also testified to the difficulties in obtaining the drugs to conduct research: While anyone could buy marijuana on the street on any given day, Garb had to wait seven months for his research supply and knew others who had waited up to two years.
However, marijuana remained a Schedule I drug-a substance with potential for abuse and no medical uses. Despite a number of petitions to move marijuana to Schedule II, the DEA refused even to hold a public hearing on the issue. So while the federal government resisted, states took the initiative. By the late 1980s, 34 states had passed some form of medical marijuana legislation. Several states organized marijuana research programs so they could legitimately obtain synthetic THC-and in a few cases, marijuana-from the federal government, for suffering patients. Results from studies, though not rigorously scientific, conducted in New Mexico, Tennessee, New York, and elsewhere, found that smokable marijuana and THC outperformed the best available prescription drugs, reporting success rates close to 90 percent; anecdotal evidence suggested that smoked marijuana was more effective than Marinol, the synthetic THC pill.
Finally, in 1985 the coalition of doctors, patients, and marijuana activists persuaded the Department of Health and Human Services to move Marinol to Schedule II, making it legally available by prescription to patients. Soon after, the DEA announced that public hearings on the rescheduling of marijuana itself would finally be held. Those hearings lasted two years and culminated in the recommendation of DEA Administrative Law Judge Francis L. Young in 1988, who wrote that
it is unrealistic and unreasonable to require unanimity of opinion on the question confronting us. For the reasons there indicated, acceptance [of marijuana having a medical use] by a significant minority of doctors is all that can reasonably be required. This record makes it abundantly clear that such acceptance exists in the United States. . . . One must reasonably conclude that there is accepted safety for use of marijuana under medical supervision.
But the DEA administrator did not act on this recommendation and marijuana remained in Schedule I.
The pro-legalization National Organization for the Reform of Marijuana Laws (NORML) petitioned the DEA to reschedule marijuana for review again in 1992. Denying this petition, DEA Administrator Robert Bonner wrote in the Federal Register, "Our nation's top cancer experts reject marijuana for medical use." To support his claim, he cited the testimony of David S. Ettinger, a professor of medicine at Johns Hopkins University School of Medicine and "nationally respected cancer expert," who said: "There is no indication that marijuana is effective in treating nausea and vomiting resulting from radiation treatment or other causes. No legitimate studies have been conducted which make such conclusions."
Bonner thus concluded, "Not one nationally recognized cancer expert could be found to testify on marijuana's behalf." But in a recent phone interview, Ettinger said he had changed his position. He now believes that in cases of intractable nausea "smoking marijuana is reasonable" and that there are "patients for whom therapies don't work and in that situation anything is worth trying." He also said a study should be conducted comparing the efficacy of smoked marijuana to Marinol.
F rom the late 1980s up to the present, the federal government has appeared content to close the book on the medical marijuana question, inhibiting any attempts at further research of its medical utility, and limiting research to marijuana's negative effects. In 1994 Dr. Donald Abrams, a California AIDS specialist, submitted a research proposal to compare smokable marijuana and Marinol because, he said, "we have 1,100 AIDS patients in the Bay Area using marijuana [on their own]." Abrams's draft proposal did not pass peer review, but the FDA helped Abrams develop a revised proposal, which was approved by several California research committees and submitted in August 1994. After a delay of nine months, Abrams received a letter from Dr. Alan Leshner, director of the NIDA, turning down the proposal and leaving no room for further negotiation over revisions. "As an AIDS investigator who has worked closely with the National Institutes of Health and the U.S. Food and Drug Administration for the past 14 years of this epidemic, I must tell you that dealing with your institute has been the worst experience of my career!" Abrams replied.
Polls show broad support for medicalization. An ABC/Discovery Channel nationwide poll conducted in May found that 69 percent of respondents favored permitting doctors to prescribe marijuana. Now, after several years of relative quiet, states and local organizations are again pursuing the issue of medical marijuana. The California Medical Association recently backed a bill in May that would provide $6 million for researching the medical benefits of marijuana, and Americans for Medical Rights is gearing up to get medical marijuana ballots placed in a half dozen states for 1998. In addition to the California and Arizona referenda, the state governments of Massachusetts and Washington are creating programs to distribute marijuana to qualifying patients, though of course these programs are contingent on federal approval. In a sense, these could be test cases, signaling whether federal health officials will keep an open mind about the potential medical benefits of cannabis.
RAISING THE HURDLE
In the past, the DEA argued that marijuana had no accepted medical use. Now the government has altered that argument subtly, raising the hurdle for a revision in its policy. Director McCaffrey, in testimony December 2, 1996, before the Senate Judiciary Committee, stated, "There is no scientifically sound evidence that smoked marijuana is medically superior to currently available therapies [emphasis added]."
There are, in fact, some new anti-nausea treatments that may provide relief comparable or superior to marijuana. For example, new anti-emetic drugs such as Ondansetron and Kytril (trade names), are administered to patients intravenously, and work well. But they are difficult to administer and are astronomically expensive. In tablet form, for outpatient chemotherapy, Kytril retails for around $86 for a daily two-milligram dose. Legal marijuana would cost just a few cents a dose. Moreover, it is not FDA policy to disallow one treatment simply because another, more expensive or elaborate one is available. Dr. Robert Temple, associate director for medical policy in the Center for Drug Evaluation and Research at the FDA, who also attended the NIH workshop, told the New York Times, "FDA approval does not require that any [new] drug be better than, or even as good as, an existing drug." Such an action would be equivalent to the FDA denying approval to, say, Pepcid, because Tagamet is a sufficient acid-blocking drug.
Other Schedule I drugs have been rescheduled because they provided relatively minor increased flexibility or improvement in treatment. LAAM (L-alpha-acetylmethodol), a drug now used with or in place of methadone to treat heroin addicts, was recently moved from Schedule I to II because it can be taken every other day compared to the required daily prescription of methadone. This allows recovering addicts to use the day in the middle for counseling.
M any AIDS patients suffer from AIDS wasting syndrome, during which they are so sick they cannot eat. Chemo-therapy and radiation-treatment patients often suffer from extreme nausea and vomiting. All of these patients might be candidates for marijuana therapy, to promote appetite and relieve nausea and vomiting. Many patients smoke marijuana that they obtain illegally because they can control the dosage: The palliative effects occur about 45 minutes faster and the psychoactive effects go away more quickly than when the patients take Marinol. Ironically, the government approved Marinol in part because it seemed less "recreational" than smoked marijuana. But clinically, the psychoactive effects of Marinol characteristically last nearly eight hours, while those of a comparable dose of smoked marijuana generally last between two and four.
Moreover, for patients suffering from extreme nausea and vomiting, the Marinol pill is not practical because they may not be able to retain it. In the 1980 congressional hearing on marijuana, Dr. Steven Sallan testified to the benefits of smoking as a venue for ingesting anti-nausea medication:
There is no question in my mind that the oral route for an anti-emetic, a pill, is the absolute worst route for the patient who has a lot of anticipatory nausea and vomiting. . . . The smoke route is in some ways ideal. Certainly when we want a drug to be absolutely sure, general anesthesia, we put it on the face, they breathe it across their lungs, it's in their bloodstream immediately.
Dr. Lester Grinspoon, author of Marihuana: The Forbidden Medicine, says it may be possible to inhale only the therapeutically effective chemicals of marijuana and leave the tar and carcinogens behind. He attests that marijuana can be heated to a certain point at which the cannabinoids (the pharmacologically effective chemicals) are released, but the plant will not actually burn. "In the future, [patients] will be inhaling the vapors of marijuana," Grinspoon said, if the government allows the technology to be developed. In an April interview in the online magazine Salon, Dr. William Beaver, professor of pharmacology at Georgetown and chair of the NIH workshop, mentioned the possibility of developing such a delivery system. Currently, however, paraphernalia laws forbid the production or the sale of marijuana vaporizers.
A TROJAN HORSE FOR LEGALIZATION?
Is medical marijuana just a stalking horse? It's true that pro-legalization organizations such as NORML play an active role in the med ical marijuana movement. Philanthropist George Soros and his Drug Policy Foundation, advocates of general decriminalization, have financially backed medical marijuana initiatives. A February 17 article in the New Republic, "The Return of Pot" by Hanna Rosin, also characterized the raison d'être of the medical marijuana movement as general legalization. "The truth about the marijuana movement is . . . blindingly obvious after a day in [Dennis] Peron's club. The movement is . . . primarily about legalization," Rosin wrote. While the movement "may feature billboards of the infirm . . . in the offices of its activists you are more likely to find a different poster, a stoner classic: The Declaration of Independence and the Constitution Were Written on Hemp Paper."
The reality is that the medical legalization coalition includes pot-heads, scientists, oncologists, patients, and social reformers. Bill Zimmerman, who coordinated California's pro-legalization Proposition 215, says, "Some people supporting medical marijuana initiatives are without question using it as an attempt to legalize marijuana. Other people are supporting marijuana policy changes out of a genuine concern for patients. It's a free country." And while Rosin paints a pretty bleak picture of the California marijuana scene-scrawny pot junkies with grimy teeth using excuses of migraine headaches to legitimately obtain their fix-she leaves out biographies of activists like conservative notable William F. Buckley, Jr., who found marijuana's medical illegality absurd when his sister preferred it to standard drugs in alleviating the negative affects of her chemotherapy. Ironically, it is marijuana's medical illegality that perpetuates the very cannabis clubs Rosin finds contemptible. Such clubs would largely disappear if marijuana were available by prescription.
One curious footnote to this controversy is that the federal government is currently dispensing smokable marijuana-to eight individuals. The Food and Drug Administration began the Single Patient Investigational New Drug Program (commonly know as compassionate IND) in the mid-1970s. Settling out of court in the case Randall v. U.S., the federal government determined it would provide Robert Randall, who suffered from glaucoma, smokable marijuana legally. Fourteen people in all were admitted to the compassionate IND program before its suspension in 1990 and its closure in 1992. The FDA ended the program due to a deluge of applications-again, the government was worried about the public perception of liberally dispensing the drug. Nonetheless, eight people, beneficiaries of a grandfather clause, continue to receive federal marijuana to this day.
T he strongest argument against prescribed marijuana remains the concern that it would remove whatever stigma marijuana retains and thus proliferate recreational usage. Joseph Califano, president of the National Center on Addiction and Substance Abuse (CASA), wrote in a Washington Post op-ed attacking medical legalization:
Our children are at stake here. . . . A state has an enormous interest in protecting children from proposals likely to make drugs such as marijuana, heroin and LSD more acceptable and accessible.
But would making marijuana prescribable do either? The list of dangerous and addictive drugs currently prescribable by physicians is enormous and all of them are tightly controlled by the DEA. Although opiates have been abused for centuries, drugs such as codeine, morphine, and dilaudid are carefully regulated, widely prescribed, and relieve the suffering of millions. The use of cocaine has declined drastically from 5.7 million people in 1985 to 1.4 million in 1994, and the drug is a prescribable Schedule II controlled substance.
At the 1980 congressional hearing, North Carolina Congressman Stephen Neal, the chairman of the task force, responded to similar fears expressed by the NIDA spokesperson in the following testimony:
I have two teenage children. . . . They are at the prime age for exposure to these drugs. . . . It seems to me, watching them and watching what our government has done over the years, that we have spread a good deal of misinformation . . . and that people, and young people in particular respond very positively to accurate information. . . . I really think that my own kids can understand the difference between a use of a drug for a particular illness and its recreational use. . . . It just doesn't seem reasonable to me we would have to sacrifice the potential for some good use of these drugs . . . it doesn't seem consistent. Not only that, but I think kids will see right through it.
However, for President Clinton and many other elected officials, the question is not so simple.
H aving spent decades branding marijuana a killer weed, the government is caught in its own rhetoric. This administration, like previous ones, is fearful that if it softens on the issue of the medical use of marijuana, it risks being labeled soft on drugs. When President Clinton began cutting the drug war budget during his first term, he was soon confronted with harsh criticism from the right-William Bennett wrote in a 1995 congressional testimony, "The Clinton Administration suffers from moral torpor on this issue"-and with claims of increased marijuana use among teens. These factors led Clinton to announce the largest drug war budget ever for 1996. Again in 1997, the United States has appropriated $16 billion for the drug war budget.
It remains to be seen whether the federal government will have the courage to allow scientists to resolve the issue of marijuana's medical use in the face of pot's long-standing cultural stigma. But the government will not depress recreational marijuana use or make progress in the war on hard drugs by denouncing referenda, threatening prosecution of doctors, and blocking legitimate medical research. It will only make it more difficult for severely ill people to relieve their suffering.
