Shouldn't all medicines used in the U.S. be approved by the Food and Drug Administration?

Gaining FDA approval for a drug is a very long and costly process. As a result, many products on the market which are widely used for health purposes are not approved by the FDA for those uses. Many of these products are also safe and effective, even though they lack FDA approval.

For instance, many people take fish oil supplements to lower their cholesterol, or take calcium and vitamin D supplements for bone strength. These are not specifically approved by the FDA, but studies have shown them to be both safe and effective. Additionally, physicians often prescribe medications for uses other than their original FDA-approved uses (off-label prescribing).

It's also worth noting that FDA approval is no guarantee of safety.  FDA-approved Vioxx is estimated to have caused between 26,000 and 55,000 needless deaths before it was pulled from the shelves.  By contrast, there are no recorded deaths from marijuana overdose in human history.

Although the FDA has refused to study marijuana, many scientific studies have shown it to be safe and effective. For example, a randomized, double-blind, placebo-controlled clinical trial of smoked cannabis was published in the Journal of Pain in June, 2008. Patients with painful nerve injuries who smoked precisely controlled doses of marijuana experienced relief from pain which was significantly better than those who were given the placebo. The marijuana in this study was well tolerated and had minimal psychoactive effects.

Despite studies that demonstrate clear medical benefits to some patients from using marijuana, political barriers will likely continue to preclude it from being evaluated by the FDA. 

What are the specific medicinal uses of marijuana?

Patients use marijuana for a variety of painful and debilitating conditions. It has analgesic (pain relieving) effects. It can reduce muscle spasticity; it can also diminish nausea and vomiting and increase appetite. Some of the most common general conditions for which patients use marijuana are as follows: neuropathic pain (pain from a nerve injury), glaucoma, muscle-wasting illnesses, painful muscle spasms, multiple sclerosis, fibromyalgia, and nausea/vomiting caused by illnesses or cancer chemotherapy.

If New Hampshire's medical marijuana patients are not routinely arrested for marijuana possession, why is this reform necessary?

The stigma of being labeled a "lawbreaker" may appeal to rebellious youth, but it tends to have the opposite effect on seriously ill patients.  Consider the example of Concord resident Barbara Filleul, who was given an ounce of marijuana by a friend while enduring chemotherapy, but chose to endure severe side-effects rather than use it. 

Seriously ill patients have been arrested and incarcerated in other states, and they are threatened with possible arrest and incarceration in New Hampshire, simply for trying to relieve their symptoms.  So it isn't just about who goes to jail and who doesn't; for these patients, it's about having safe access to marijuana that is not produced or sold in the black market.  If a doctor determines that marijuana is the best treatment for a patient, that patient must be able to obtain and use marijuana which is of adequate and consistent quality, and the stigma of illegality associated with marijuana's legitimate medical uses must be removed. 

Don't federal laws make it difficult for a state to protect medical marijuana patients?

Since shortly after the World Trade Center attack, the U.S. Drug Enforcement Administration (DEA) has selectively conducted raids on medical marijuana dispensaries and grow operations in California, where medical marijuana has been legal since 1996.  During his campaign, President-elect Barack Obama indicated on several occasions that raids in states which recognize medical marijuana would not continue in an Obama administration.

Even under President Bush, who vigorously opposes medical marijuana, DEA interference has not been a significant problem in states with tightly crafted medical marijuana laws (such as our neighbor states Vermont and Maine), . Since 99% of marijuana arrests nationwide are made by state and local law enforcement, the bill being proposed in New Hampshire would provide seriously ill patients with a strong degree of protection against arrest and criminal prosecution.

What does it mean when people say marijuana is a Schedule I controlled substance?

In 1970, the Controlled Substances Act (CSA) was passed into federal law.  This act consolidated previous federal drug laws under one legislative umbrella and shifted responsibility for drug enforcement from the Treasury Department to the Department of Justice.  A new federal agency, the Drug Enforcement Administration (DEA), was created under the Department of Justice to enforce the CSA. 

The CSA also established five schedules for substances based on their demonstrated safety and abuse potential.  A drug is supposed to be placed in the highest schedule, Schedule I, if it meets the following criteria:

(A) The drug or other substance has high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Schedule I drugs cannot be prescribed by doctors, and they cannot be produced or studied by researchers without DEA permission.

The Schedule I list includes heroin, marijuana, LSD, MDMA, psilocybin (mushrooms), peyote, and mescaline.  Many are surprised to learn that cocaine, opium, morphine, and oxycodone are Schedule II, and anabolic steroids are listed in Schedule III.  Alcohol and tobacco were exempted from the scheduling system altogether.

If marijuana doesn't belong in Schedule I, why hasn't its status been changed?

Marijuana's inclusion in Schedule I was at first considered temporary, pending an expected report from President Richard Nixon's National Commission on Marijuana and Drug Abuse (a.k.a. the Shafer Commission -- Nixon had chosen Raymond P. Shafer, a former Republican governor from Pennsylvania, to serve as chairman).  However, the Commission's 1972 report, titled "Marijuana: a Signal of Misunderstanding," acknowledged marijuana's safety relative to other drugs and recommended decriminalization.  Obviously, the Nixon administration did not implement the report's surprising recommendations.

Since 1972, several petitions to reschedule marijuana have been "considered" by the DEA.  In 1986, the DEA finally held public hearings on the issue of marijuana rescheduling.  After two years of hearings, DEA Chief Administrative Law Judge Francis L. Young ruled in 1988 that the scheduling standards established in CSA "permit and require the transfer of marijuana from Schedule I to Schedule II."  He added: "Marijuana, in its natural form, is one of the safest therapeutically active substances known. It would be unreasonable, arbitrary, and capricious for the DEA to continue to stand between those sufferers and the benefits of the substance."

Unfortunately, Young was overruled by DEA administrator John Lawn.  In 1994, the D.C. Court of Appeals affirmed Lawn's authority to overrule Judge Young's decision.  Disgusted after nearly 25 years of DEA stonewalling, seriously ill patients and their advocates decided to focus their efforts at the state level, and since 1996, 13 states have passed laws protecting seriously ill patients from arrest.

Marijuana must someday be rescheduled at the federal level, but seriously ill patients who benefit from marijuana can't afford to wait for a federal reform which more than once has seemed to be just around the corner.  State medical marijuana laws do not create perfect policy, but they are the best a state can do for its citizens in light of this continued antagonism from the federal government. 

To be clear, the law proposed in NH does not affect marijuana's schedule.  It simply exempts seriously ill patients from penalties, provided that they receive a doctor's recommendation for marijuana and proceed in compliance with the law's tightly-crafted restrictions.

Isn't a synthetic alternative to marijuana already available?

This is similar to the question Mitt Romney asked Clayton Holton, referring to the FDA-approved pill Marinol, a drug designed to replicate marijuana's medicinal benefits.  "It makes me sick; it makes me throw up," Clayton explained.

Some patients do find relief with Marinol, which contains Delta-9 Tetrahydrocannabinol (THC) that has been synthesized in a lab.  However, many do not, and the drug is very expensive.  THC is only one active compound in marijuana, and scientists are only beginning to learn about the complex relationships between THC and other cannabinoids.

Even if an effective marijuana pill can one day be developed, smoked or vaporized marijuana will still be essential medicine for patients suffering from extreme nausea.  For many, including cancer patients undergoing chemotherapy, there can be no substitute for the rapid onset of relief provided by inhalation; pills are useless unless the patient is able to keep them down.