On Oct. 16, the U.S. Court of Appeals for the D.C. Circuit, the federal appeals court that usually handles cases involving government regulations, will hear oral arguments onAmericans for Safe Access v. DEA. It will be the first time in almost 20 years that federal courts have considered the science of medical marijuana, says ASA spokesperson Kris Hermes.
Specifically, ASA, a California-based patient-advocacy group, is trying to get the Drug Enforcement Administration to move marijuana out of Schedule I, the Controlled Substances Act of 1970s category for drugs with “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and no “accepted level of safety for use under medical supervision.” Heroin, LSD, and PCP are also in Schedule I. Cocaine, methamphetamine and OxyContin are in Schedule II, legal for medical use but strongly restricted.
Two previous attempts to get the DEA to reschedule marijuana failed, but advocates believe there is enough new evidence to convince the courts. “There’s simply more science now,” says ASA chief counsel Joseph D. Elford. Since 2000, says Igor Grant of the University of California at San Diego’s Center for Medicinal Cannabis Research, the center has done six studies that showed “efficacy for marijuana over a placebo” in relieving pain caused by peripheral neuropathy (nerve damage).
This current attempt began in 2002, when a coalition of medical-marijuana and legalization advocates filed a petition with the DEA. It contended that cannabis “has an accepted medical use in the United States, is safe for use under medical supervision, has an abuse potential lower than Schedule I or II drugs, and has a dependence liability that is also lower than Schedule I or II drugs.” It requested that marijuana be moved to Schedule III (Vicodin, acetaminophen with codeine), Schedule IV (Valium, Xanax), or Schedule V (codeine cough syrup).
“Based on evidence currently available, the Schedule I classification is not tenable,” Grant wrote in the 2012 issue of the Open Neurology Journal. “It is not accurate that cannabis has no medical value, or that information on safety is lacking. It is true cannabis has some abuse potential, but its profile more closely resembles drugs in Schedule III.”
The DEA rejected the petition in June 2011. Administrator Michelle Leonhart declared that marijuana had no accepted medical use, because no form of it has been approved by the Food and Drug Administration. The Department of Health and Human Services had previously concurred that it had a high potential for abuse, because an estimated more than 14 million people get high illegally at least once a month.
“They only responded to the petition after we filed a lawsuit alleging unreasonable delay,” says Elford. “Delay, delay, and then delay some more. The government doesn’t want to take on whether marijuana has medical use.”
The DEA refused to comment on the lawsuit. It referred calls to the Justice Department, which did not return phone calls.
The DEA has consistently refused to reclassify marijuana. It did move Marinol, synthetic THC capsules, from Schedule II to Schedule III in 1999. It insists that is a viable alternative for anyone who claims they need medical marijuana. (Marinol’s manufacturer was then advertising it to AIDS patients with the slogan “This is your appetite… This is your appetite on Marinol.”) Most medical-marijuana users, however, prefer real cannabis, because smoking it or inhaling vaporized THC provides much faster relief than taking capsules orally, and as with eating marijuana, oral doses are much harder to control.
“It’s just not as effective,” says William Brent, a 52-year-old California man who is a plaintiff in the ASA suit. Brent, who suffers from seizures, depression and chronic pain cause by bone abnormalities, has sought relief from prescription painkillers, muscle relaxers, antiseizure, antianxiety, and antinausea drugs—but says “cannabis is the one that works best for me.”
Donald Abrams, director of clinical programs at San Francisco General Hospital—where he worked in the nation’s first AIDS clinic—finds it “a bit ironic” that cannabis is in Schedule I, completely illegal, when its main active ingredient is in Schedule III.
The DEA rejected two previous petitions to reclassify cannabis. The National Organization for the Reform of Marijuana Laws first challenged the Schedule I classification in 1972, on the grounds that marijuana had valid medical use. The Alliance for Cannabis Therapeutics, a medical-marijuana group founded by pioneering patient Robert Randall, joined later.
It took years of litigation to get the DEA to consider that petition. When it did, in 1988, DEA administrative law judge Francis Young recommended the change, writing, in a quote often cited by medical-cannabis advocates, that marijuana was “the safest therapeutically active subject known to man.” The DEA rejected his recommendation, and in 1994 the D.C. Circuit upheld that decision.
In 1995, cannabis-policy researcher Jon Gettman and High Times magazine filed another petition, arguing that marijuana did not belong in Schedule I because it did not have a high potential for abuse. The DEA rejected it in 2001, and a federal appeals court ruled a year later that Gettman and High Times did not have legal standing to contest that decision.
This time will be different, advocates say. Scientific knowledge of marijuana has advanced dramatically in the past 20 years. The brain’s naturally occurring cannabinoids were first identified in 1992.
“There are numerous peer-reviewed studies establishing that marijuana is effective in treating AIDS wasting syndrome, muscle spasticity, emesis, appetite loss, negative side effects of chemotherapy, and chronic pain… The government, however, simply ignores these well-controlled studies,” ASA’s appeal brief says. “It is only by failing to apply the appropriate standards and make the required comparisons that the federal government could conclude that marijuana is as harmful as heroin and PCP and even more harmful than methamphetamine, cocaine and opium.”
The federal government acknowledged the medical potential of cannabis in 1999, Abrams notes, in the Institute of Medicine’s “Marijuana and Medicine: Assessing the Science Base” report. That report said cannabis-based drugs held promise for treating pain, nausea from chemotherapy, and the “wasting syndrome” from AIDS and cancer, and that “there are patients with debilitating symptoms for whom smoked marijuana might provide relief.” It also said that marijuana had a very low addiction potential, comparable to that of caffeine, Abrams adds.
Because the petition was filed in 2002, however, the court may decide not to consider more recent research. This weakens the case, says Elford—but it also denies the DEA an excuse to delay its response by saying it has to evaluate that research.
The plaintiffs will also have to overcome the argument that smoking a drug is not legitimate medicine. The DEA and prohibitionists hammer this point, and many, if not most, doctors, don’t like the idea of sick people inhaling smoke. “We see little future in smoked marijuana as a medicine,” IOM principal investigator Dr. John A. Benson said in 1999, although the report conceded that it could help in extreme cases.
Some medicines are inhaled, Abrams responds, such as those for asthma, and vaporization, in which the cannabis is heated so that the THC can be inhaled without smoke, decreases the health risk. He also cites research by Donald Tashkin of the University of California at Los Angeles, who in a 2006 study found that even people who had smoked more than 20,000 joints in their lives did not have a higher rate of lung cancer. The main respiratory risk for heavy marijuana smokers Tashkin found was bronchitis.
“Is the risk-benefit ratio favorable? Every drug has problems,” says Grant. But the evidence, he adds, suggests that marijuana could be added to the “armamentarium” with “adequate safeguards.”
The DEA’s insistence that marijuana has no valid medical use because it has not been approved by the FDA would seem to imply that the only valid medicines are those produced by pharmaceutical companies. That contrasts sharply with the FDA’s virtually nonexistent regulation of herbal “dietary supplements” that are often sold with implied medical benefits.
“There is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products,” the FDA’s Web site states.
Under the Dietary Supplement Health and Education Act of 1994, it adds, the manufacturer is responsible for determining that its herbal products are safe and not falsely advertised. If it claims that an herb will prevent, treat, or cure an illness, then the product is classified as a drug and needs FDA approval.
Manufacturers can make thinly disguised claims, however, as long as the product’s label cautions that “this statement has not been evaluated by the FDA.” St. John’s wort, often taken as an herbal antidepressant, is advertised as promoting a “positive mood balance.” Black cohosh “helps to support menopause.” Walmart sells echinacea as an “immune health supplement… used for treating various health disorders like high blood pressure, boosting energy, preventing diseases and regulating vital body functions.”
The not-approved-by-the-FDA argument is “a bit of a straw man,” says Grant. The “single, well-characterized chemical” model for medicine, he explains, is a good one, but it’s not the only one. The FDA has approved extracts and tinctures of other herbs, and is now evaluating Sativex, a cannabis extract. For marijuana, he says, “we haven’t fully figured out what combination of cannabinoids” and which methods or administration are optimal.
The federal National Institute on Drug Abuse, the only legal source of cannabis for research, has also discouraged research on its medical uses, Abrams says. When he began investigating its use in treating AIDS in 1996, NIDA told him it would not fund research on the effectiveness of cannabis, only on its abuse. He sidestepped that restriction by doing a 21-day study of whether smoking marijuana three times a day interfered with protease inhibitors in AIDS patients—and found that it didn’t, and they had better appetites and more T cells.
Meanwhile, Michael Krawitz, another plaintiff in the suit, says that the best relief for his chronic pain is a combination of cannabis and opioid painkillers—but the current laws deny him that. Krawitz, a 49-year-old Air Force veteran, has had 13 surgeries, including having part of his intestines removed, since he was seriously injured in a car accident in 1984. But the Veterans Administration refused to prescribe him any more painkillers after he refused to take a drug test. And because he lives in Virginia, where medical marijuana is not legal under state law, he can’t get a doctor’s recommendation and has to buy it on the black market, where it’s expensive and not always available. The last time he went without cannabis, he says, he almost lost the sight in his right eye.
Moving cannabis to a less restrictive schedule would enable doctors to prescribe it, and also make doing research on it easier. If the D.C. Circuit directly orders the DEA to reschedule cannabis, says Elford, that would be the most favorable result. The court could also order the DEA to hold hearings on the petition, which is what happened in the 1980s. It could also uphold the DEA’s denial.
Whatever the outcome, says Elford, the loser will likely appeal to the Supreme Court.