Marijuana, Medicine & the FDA

Jettisoning Science, Objectivity and Logic in Favor of Morally Bankrupt Politics

Bruce Mirken

On April 20, the FDA jumped into the medical marijuana controversy with a statement that was puzzling on many levels and should leave all Americans concerned about the politicization of the agency we depend on to protect our health.The document proclaimed that "no sound scientific studies" support medical use of marijuana and condemned state medical marijuana laws as an effort "to bypass the FDA drug-approval process". The FDA was wrong on both counts. The statement, a one-page press release accompanied by no references or documentation, was an odd beast. It cited neither new scientific data nor any new analysis of old data.

The FDA did not, as it often does when addressing difficult issues, convene an advisory committee of independent experts. Indeed, the document appeared to be nothing but a rehash of the government’s long-standing position. It also conveniently ignored 5,000 years of accumulated evidence of marijuana’s medical benefit. Rather than describe that evidence my self as spokesman for the organization that led the campaigns for America’s three newest medical marijuana laws, I might not be seen as an unbiased observerlet’s consider what impartial experts have found. DEA Hearing In response to a petition asking for marijuana to be moved from Schedule I of the federal Controlled Substances Act, which bars physician prescriptions, to a schedule that would allow it to be legally prescribed, Drug Enforcement Administration Administrative Law Judge Francis L. Young conducted extensive hearings in 1987 and 1988so extensive that the transcripts fill 15 volumes. Young found "uncontroverted" evidence that marijuana relieves nausea and vomiting caused by cancer chemotherapy and is an accepted treatment for these conditions. He also found strong evidence for marijuana’s benefit and acceptance as a treatment for multiple sclerosis, concluding, "The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people and doing so with safety under medical supervision. It would be unreasonable, arbitrary, and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record".

Judge Young’s decision was overruled by political appointees at the DEA, who kept marijuana in Schedule I. Eventually, an appeals court ruled that federal law allowed the DEA to ignore Young’s findings.In 1995, the American Public Health Association (APHA) adopted a policy resolution on medical marijuana, citing nearly two dozen studies reporting marijuana’s safety and efficacy against pain, nausea, vomiting, seizures, and other symptoms. The APHA urged the government "to expeditiously" make marijuana available to patients through the Compassionate Investigational New Drug program that the first Bush administration had closed to new applicants in 1991, declaring, "Greater harm is caused by the legal consequences of [marijuana’s] prohibition than possible risks of medicinal use".

Like Young, the APHA went out of its way to discuss marijuana’s remarkable safety record, noting, "Marijuana has an extremely wide acute margin of safety for use under medical supervision and cannot cause lethal reactions". In contrast, acetaminophen, the active ingredient in Tylenol, causes about 500 U.S. deaths from acute liver failure each year.Institute of Medicine ReportA year later, California passed the first effective state medical marijuana law, Proposition 215, despite opposition from the Clinton administration. Clinton’s drug czar, Gen. Barry McCaffrey, asked the Institute of Medicine (IOM) to review the existing scientific data on marijuana’s therapeutic uses. Its report, "Marijuana and Medicine: Assessing the Science Base", issued in early 1999, is available at books.nap.edu/html/marimed.Federal officials have alternated between two strategies for dealing with the IOM report. Sometimes, as in the recent FDA statement, they simply act as if it never happened. At other times, they quote out-of-context snippets that seem to support the government’s position that whole marijuana has no place in medicine, even though isolated or synthesized versions of marijuana’s active components, called cannabinoids, might while ignoring passages that contradict official policy. The IOM did indeed state that "smoked marijuana is a crude delivery system that also delivers harmful substances", and thus, "there is little future in smoked marijuana as a medically approved medication". To solve this problem, the report urged "development of a nonsmoked, rapid-onset delivery system for cannabinoid drugs".

Nevertheless, the report noted extensive documentation of therapeutic benefits from marijuana. "Nausea, appetite loss, pain, and anxiety are all afflictions of wasting and all can be mitigated by marijuana. Scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation". And while urging development of marijuana-derived pharmaceuticals, the IOM added pointedly, "Patients who are currently suffering from debilitating conditions, unrelieved by legally available drugs and who might find relief with smoked marijuana, will find little comfort in the promise of a better drug 10 years from now".Delivery SystemThe sort of nonsmoked, rapid-onset delivery system the IOM called for exists today. Vaporizers take advantage of the fact that cannabinoids vaporize at a temperature below the temperature at which the plant material starts to burn. By heating marijuana to the proper temperature, a vaporizer allows inhalation of the cannabinoids, providing the rapid onset of action and easy dose titration that patients prefer without the hazardous combustion products contained in smoke.

A study of one such product, the Volcano, published in the June 2006 Journal of Pharmaceutical Sciences, concludes with language startlingly parallel to the IOM’s "What is currently needed for optimal use of medicinal cannabinoids is a feasible, nonsmoked, rapid-onset delivery system. With the Volcano, a safe and effective cannabinoid delivery system appears to be available to patients".Multiple independent analyses (many more than can be listed here) have found that marijuana has medicinal value, and the biggest objection to its use, the pulmonary risks of smoking, has been eliminated by technology. What about the FDA’s other objection, that state medical marijuana laws somehow undercut the drug-approval process?It is, in a word, nonsense. The FDA tries to bolster its case by characterizing these laws as "making smoked marijuana available for a variety of medical conditions", but they do no such thing. State medical marijuana laws do not authorize marketing, distribution, or sales of marijuana. They simply exempt patients who meet certain conditions (usually a physician recommendation and/or diagnosis with a qualifying condition) from arrest and punishment under state laws that otherwise forbid marijuana possession or cultivation.

Indeed, the lack of a legal means for patients to obtain medical marijuana has been a source of controversy in some states, such as Rhode Island.Does the FDA not understand the difference between licensing a drug for marketing and simply choosing not to arrest individuals who possess it under certain conditions? Does the agency believe that arrest and jail is an appropriate way to deal with a patient’s choice to self-treat with an herbal product not approved as a medicine by the FDA? Do they now want to start jailing the millions of Americans who use ginseng, St. John’s wort, and other herbal products? Of course not. The FDA has jettisoned science, objectivity, and logic to help politicians prop up a morally and scientifically bankrupt policy. And that should make every American very, very nervous.