For more than half a century, the US government has maintained a hard line on marijuana, denying that the plant has any medical value at all. But in the period since 1996, during which voters in several states have approved the medical use of marijuana and the Institute of Medicine has hailed the therapeutic effects of THC (one of the cannabinoids found in the natural plant), the Feds have scrambled to revise their position. Now, the drug warriors' line goes something like this: Who needs pot, an illegal substance that burns up your lungs, when you can take Marinol, a little white pill that contains synthetic THC?
The government threw its weight behind Marinol this past July, when the Drug Enforcement Administration moved the drug into Schedule III, lifting its dangerous stigma and making it easier for doctors to prescribe. While drug czar Barry McCaffrey insisted the move was based on "pure science," a review of the players involved suggests that the rise of Marinol is more the result of politics and profiteering. Indeed, one of the studies cited by the DEA as proof of Marinol's low abuse potential was funded in part by the drug's manufacturers.
Marinol is sold in the United States by Roxane Laboratories, based in Columbus, Ohio, and Unimed Pharmaceuticals, based in Chicago. It was introduced to the market in 1985 and subsequently approved by the FDA for the treatment of nausea and appetite loss--the same symptoms that lead cancer and AIDS patients to smoke marijuana. But the pill is not always effective for patients, some of whom complain that its therapeutic effects come on too slowly and that the Marinol "high" makes it impossible to function. As a result, only about one in ten patients prefers Marinol to smoking pot, according to a worker at a California "cannabis club," which distributes marijuana to sick people. In California, many doctors prescribe both Marinol and marijuana at the same time, to make sure the patient's needs are covered.
Chuck Thomas of the Marijuana Policy Project in Washington, DC, supports access to both marijuana and Marinol. When patients ask him for advice, he says, "I tell them to first ask your doctor about Marinol, because if Marinol works for you, then you don't have to worry about going to jail." Meanwhile, the US government and drug manufacturers seem intent on blocking the availability of marijuana, denying patients that alternative.
Roxane and Unimed have been assiduously promoting Marinol to AIDS and HIV patients by making the drug available for free to those who can demonstrate financial need. And in January 1999, Roxane began running an ad for Marinol in about twenty consumer and medical journals, including Poz and The Advocate. The ad shows two images: a muffin with a bite taken out of it ("This Is Your Appetite") and an empty muffin wrapper ("This Is Your Appetite on Marinol"). No one can miss the reference to the Partnership for a Drug-Free America's famous fried-egg ad or the pointed tagline "Ask your doctor about Marinol." As the ad is careful to point out, patients may experience some side effects (such as "a feeling of being 'high'") and should avoid "hazardous" activities, such as driving, until they get used to the drug. And one more thing, the ad copy implies in a backhanded way: While studies have shown that Marinol is an effective appetite stimulant, it has yet to be conclusively proved that the drug reduces nausea for cancer patients or results in weight gain for people with AIDS.
Ironically, given the manufacturer's competition with medical marijuana, Roxane has seen a "significant increase" in prescriptions of Marinol in the states that recently passed pro-marijuana initiatives, according to associate product manager David Querry. (The roster now includes Alaska, Arizona, California, Colorado, Nevada, Oregon and Washington.) As a result of the new laws, more patients ask for marijuana--but doctors have responded by prescribing Marinol first.
Standard practice dictates that doctors prescribe all conventional medications before offering an experimental drug as a treatment of last resort. But Roxane presents Marinol as a solution, not an option, for physicians who are "torn" when patients ask for marijuana. "What do they do?" asks Querry. "Honor the patients' wishes and recommend a medication that doesn't have identified medical studies to prove its safety and efficacy--or fall back on an FDA-approved product with fourteen years of history on the market?"
Only time will tell whether Marinol can capture the medical-marijuana market. But Roxane isn't taking any chances. Since 1996, when Californians first endorsed medical marijuana, the company has been waging a high-powered PR campaign. According to Querry, the company retained Hill & Knowlton "to educate the physicians and the public and the legislatures" about Marinol, because the drug is often mischaracterized by advocates of medical marijuana. Roxane describes this activity as public education, not lobbying.
The company also sought out respectable doctors who would tour states where marijuana initiatives were being launched. The lineup it settled on included Dr. Gary Cohan, an HIV specialist who helps run the Pacific Oaks Medical Group in Beverly Hills; Dr. David Smith, an HIV specialist who founded the Haight-Ashbury Free Clinics in San Francisco; and Dr. Lonnie Bristow, a San Pablo-based internist. In September 1997 Drs. Cohan, Smith and Bristow met with the editorial board of the Tacoma, Washington, News Tribune to sing the praises of Marinol. Their arguments were repeated in a long opinion piece by the News Tribune's chief editorial writer, who noted, "Roxane was footing the bills for the trip, but the physicians in question cannot be dismissed as mere shills."
By the spring of 1998, Dr. Cohan had become ubiquitous on the marijuana policy circuit. Within about a year, he testified in a federal court case involving marijuana in California, spoke at a "Marijuana Education Summit" in Florida and represented Roxane's interests at a legislative hearing on marijuana in Colorado, along with Drs. Bristow and Smith. Meanwhile, Dr. Smith was doing his part on the research front, thanks to a grant from Roxane's partner, Unimed Pharmaceuticals, to the Haight-Ashbury Free Clinics. In June 1998 Roxane announced the results of a nine-month study conducted by Smith that found "no evidence" that Marinol had ever been abused or sold as a street drug. A year later, when the DEA moved Marinol to Schedule III, the agency cited Smith's study but did not disclose that the study was partly funded by the very company that would profit from the rescheduling and that has helped the government keep marijuana on the blacklist.
Like Dr. Smith, Dr. Cohan has continued to represent Roxane's interests without fanfare. In March, after the Institute of Medicine announced that THC has a distinct therapeutic value, Cohan appeared on CNBC's Rivera Live as an authority on HIV. He dismissed the idea of "allowing people to smoke a crude plant material to get a medicine of unknown dose with lots of contaminants"--but did not disclose his financial ties to Roxane.
A Roxane spokesperson, asked about the doctors' apparent conflict of interest, said that doctors like Cohan and Smith get many speaking invitations and that the company occasionally picks up the expenses. But, he said, the American Medical Association does not require doctors to disclose any affiliation with industry, except in the context of continuing medical education. Asked about the Smith study, he pointed out that drug manufacturers typically pay for clinical trials and that paying for a study does not mean a company can influence the conclusions.
A DEA spokeswoman said the agency based its decision to reschedule Marinol on many factors, of which the Smith study was just one. If only the government would give the same credence to the voluminous evidence that marijuana is good medicine, too.