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Waiting to inhale: hemp for health?

November, 1997

SAN FRANCISCO -- Since Proposition 215 legalized marijuana as medicine in California, as many as 1,200 people have flocked daily to just one of the seven buyers' clubs in the Bay Area. There, they can purchase pot to "treat" conditions from headaches to AIDS. Yet the question remains: Does basic scientific evidence support the use of hemp for better health?

GIVEN THAT one in three adults has smoked pot at some point, that marijuana is this state's biggest cash crop, and that hundreds of thousands of Californians are smoking it to relieve a variety of ills, one would expect plenty of data to be available on marijuana as medicine. Yet while anecdotal testimonials suggest pot should take its rightful, though perhaps limited, place in the American pharmacopia, the rigorous long-term studies that modern science demands before a drug can be declared safe and effective have yet to be done.

The reason, say marijuana's proponents, has nothing to do with science and everything to do with politics. The government has continually blocked researchers' efforts to obtain the high-grade marijuana necessary for a study to qualify as good science, they say.

The U.S. Food and Drug Administration will only recognize a study as good medicine if the marijuana comes from one source: a federally funded pot farm in Mississippi. The catch: access to the crop is controlled by the National Institute on Drug Abuse, which reviews all cannabis study proposals. And NIDA, critics say, has traditionally resisted sharing its stash with scientists whose results might clash with its own agenda -- the war on drugs. Until now.

San Francisco AIDS specialist Dr. Donald Abrams has been trying to unravel marijuana's mysteries since 1992, when he proposed a pilot trial to determine if marijuana helps to increase appetite in HIV-positive patients -- give them the "munchies," as it were -- thereby warding off the debilitating weight loss associated with the AIDS wasting syndrome. "But our proposal was turned down time and again," he says.

So scorching were the repeated rejections that he was taken by surprise when last month, he was finally granted approval for the first federally sponsored study of the medical effects of marijuana in AIDS patients.

Proponents of pot say it helps AIDS patients keep eating; relieves nausea and vomiting in patients undergoing chemotherapy; alleviates the chronic pain of conditions including headaches, arthritis and degenerative nerve disease; reduces spasticity in multiple sclerosis patients; and lowers the increased intraocular pressure associated with glaucoma. Were the anecdotal reports about the benefits of cannabis finally too numerous to ignore?

Not exactly, says Abrams of the University of California, San Francisco. "It was a rather unique coming together of science and politics" that got his study approved, he says.

First, Prop. 215 was passed, granting medical pot rights to patients with "any illness, for which marijuana provides relief," and opening up dialogues between doctors and their patients.

But ironically, many believe that bluster in response to Prop. 215 by Clinton Administration drug czar Barry McCaffrey may be the most directly responsible for the new commitment to research.

On Dec. 30, less than two months after Prop. 215 was passed -- sending, according to McCaffrey, the "wrong message to children" -- the drug czar stepped over a line. During a televised press conference, McCaffrey told the nation that Californian doctors who "recommend or prescribe Schedule I controlled substances" such as marijuana are subject not only to criminal prosecution, but also to losing their licenses, their prescribing privileges, and their eligibility to receive Medicare and Medicaid fees.

Doctors did not take the unprecedented threat lightly. There was an uproar in the medical community; articles in the New England Journal of Medicine called such federal policies "misguided, heavy-handed and inhumane," Abrams recalls. And physicians began calling for further research. Even those like Dr. Avram Goldstein, who says he doesn't buy into "the conspiracy theory" that the government was trying to impede research, agree.

"McCaffrey made a serious mistake," says Goldstein, professor emeritus of pharmacology at Stanford University in Palo Alto and a member of the National Institutes of Health panel that reviewed all the available data on marijuana as medicine earlier this year. Buyers' clubs offer not only a choice of different grades of pot, but also a variety of marijuana baked goods.

The California Medical Association, which had opposed Prop. 215, also joined forces against McCaffrey's threats, says Dr. Jane Marmor, a cancer specialist and chair of the CMA's technical advisory committee on medical marijuana. A lawsuit was brought against the federal government and "the doctors won," she says. The upshot: "Physicians may speak freely and discuss with their patients any procedure, treatment, substance or device that may affect a person's health."

At the same time that the political air was clearing for more cannabis research, scientific events were moving ahead, with a prestigious NIH panel also recommending more clinical studies. The panel of nine experts reviewed some 100 studies on marijuana, both in the smokable form and in the tablets, Marinol, that are already approved by the FDA. Made by Roxane Pharmaceuticals, Marinol is synthetic THC, the active ingredient in marijuana. As for THC itself, the panel agreed that there was very strong evidence that the chemical has some medicinal use: It is more effective than a placebo in stimulating appetite, for example. But is THC taken by mouth as effective as smoking a joint?

Natural marijuana pills made from dried pot and olive oil offer patients at a San Francsico buyers' club an alternative to Marinol or smoking. No, the panel concluded. "The route of inhalation is more effective and works more quickly," Goldstein says. "And the effects are more controllable because the patients can adjust the dose more easily."

Patients complain they become "zonked" when they take Marinol pills, Abrams says. Because the pills must be absorbed through the digestive system, they are slower to take effect and slower to wear off than the smokable product.

And of course, chemotherapy patients suffering from severe nausea can't keep tablets down, he adds. Nevertheless, the panel of experts was not prepared to recommend that patients start smoking marijuana, which contains not only THC, but as many as 400 other, little-understood compounds. "You have to be concerned about contaminants, about long-term toxic effects," Goldstein says. (At the same time, he noted, such concerns may be minimal if the patient is already dying.)

The panel came up with an alternative to smoking: a marijuana inhaler, similar to those used to deliver asthma drugs. Absorption, and all its benefits, would be the same as when the drug is smoked. No drug company has yet developed an official toking device, though Goldstein says that development is only a matter of time.

Given that Abrams is to conduct the first federally approved marijuana study, where did the researchers get the pot for the 100 studies that the NIH panel reviewed? Most of the studies used THC, not marijuana itself, Goldstein says. The grade of pot used in smoking studies was questionable, and many were performed on animals.

And, of course, there were anecdotal reports from patients. He recalls one glaucoma patient who said at a public session that she had smoked three to five joints a day for 17 years and both she and her doctor thought it helped her eye condition. "It's hard to tell if it did," he says. "People like to think they're being helped, even by sugar pills."

But some doctors who treat AIDS and cancer patients are sure. In her practice, oncologist Marmor sees cancer patients in all stages of illness. "One elderly patient with metastatic prostate cancer told me he had smoked, that it took the pain away," she says. "I have patients for whom it helps pain and nausea, others who say it makes the nausea that accompanies chemotherapy worse."

Marmor, speaking for both herself and the CMA, echoes the call for more research. And if the studies show marijuana is effective even for just a limited number of patients, it should be legalized for prescription use, she says. "Cocaine is a medication with few medical uses and plenty of room for abuse, but it's legal for me to prescribe that."

Abrams is gearing up to start his research -- inspired, in part, by his AIDS patients' positive experiences -- in January. In the trial, 63 HIV-positive volunteers will be divided into three groups for the 25-day study period: one group will smoke joints rolled from NIDA-supplied pot with 4 percent THC three times a day; one group will take Marinol three times a day; and one group will be given placebo pills.

At this stage, the study is designed only to determine whether marijuana is safe when taken in combination with the protease inhibitors that have become a standard part of the drug cocktails given to many HIV-positive patients. "Both marijuana and protease inhibitors are degraded by the liver, so there's the risk of drug-drug interactions," he says. "Marijuana could allow protease levels to get too high, or too low. Either way, there are dangers." While the study will also look at weight gain and appetite, a longer, larger clinical trial to measure marijuana's effectiveness will not begin until its safety is proven, Abrams says.

Though its results may still be a year away, the San Francisco doctor says he's "delighted" to have a green light for the study. "If there is a product in nature that provides medical benefit, that might be a better way [than to manipulate the product] into a little gelatin capsule," he says. "Maybe that's why it's there. In Western medicine, we don't appreciate that much."