Gregoire’s case for medical pot cuts into feds’ tangled legal web
by John Stang
Credit: Photo: Flickr user dankdepot
Carol Hadle calls her tiny pot pipe “my little bullet.” All sorts of pain take turns attacking her.
Hatpin-like pricks. Mild heat flowing through her body. Electric-like shocks. Really bad. No so bad. No real pattern. Exhausting.
Sometimes her limbs act and feel like spaghetti. Her hands constantly tremble. She cannot hold a thin pen, instead using fat ones to produce clumsy childlike writing. The Tacoma woman suffers from Charcot-Marie-Tooth Disease — a slowly progressive genetic neurological disorder. The nerves carrying signals between her muscles and her brain and spinal cord work haphazardly. Her body’s internal messages of pain and touch are messed up.
“I would do anything for relief,” said Hadle, who had to quit her housekeeping job because of the pain and shakiness.
She takes vicodin and methadone. And marijuana helps. A lot. “I’d like to be able to go down to my pharmacy and pick it up,” Hadle said.
The medical relief experienced by Hadle, 44 years old, and many other patients has put Washington Gov. Chris Gregoire, a former state attorney general, and Rhode Island Gov. Lincoln Chafee in the forefront of states’ efforts to push the federal government to reform its handling of marijuana under drug laws. They are seeking changes in the federal rules that make it impossible for doctors and pharmacists to treat marijuana as a prescription drug.
Physicians and pharmacists are blocked from using marijuana as a drug by the fact that marijuana is classified by federal agencies as a Schedule I drug, and not a Schedule II drug, as Gregoire and Chafee seek.
Schedule I means a drug has no current accepted medical use in the United States. Schedule I drugs include marijuana; heroin; GHB, the infamous date-rape drug; and LSD. The bottom line is that doctors cannot prescribe these drugs to be picked up at pharmacies.
Schedule II means there is a current accepted medical use, but the drug has a high potential for abuse, including possibly severe psychological or physical dependencies. Schedule II drugs include morphine, methadone, fentanyl, methamphetamine, hydrocodone, cocaine, and even PCP. The bottom line is that doctor are legally allowed use or prescribe these drugs.
That sets up a conflict between the federal government and 16 states that have passed laws to allow medical marijuana in limited amounts. Federal law trumps state law, if the feds are in the mood to enforce it. That conflict led Gregoire to veto most of a medical marijuana bill earlier last year, citing the danger of state employees being arrested by the feds.
“The laws are confusing,” said Dr. Gregory Carter, a Centralia physician and a University of Washington Medical School faculty member who has extensively studied medical marijuana. “Patients are confused. Physicians are very confused.”
In November, Gregoire and Chafee sent a letter to President Barack Obama, Congress, the federal Drug Enforcement Agency and the federal Food and Drug Administration ito request that medical marijuana be reclassified as a Schedule II drug — the first time that state governors have made this request. Since then, Vermont, Colorado, Hawaii, and Connecticut have voiced their support.
Because the request came from governors, the feds are legally obligated to reply. However, there is no limit to the time that the Feds can wait before replying other than a “reasonable” period, said Jason McGill, Gregoire’s executive policy adviser for health care.
The federal Drug Enforcement Agency (DEA) makes the actual decision about a drug, but relies on U.S. Food and Drug Administration (FDA) to make recommendations on the scientific and medical matters, including the schedule classifications. The DEA referred questions to the FDA. The FDA has evaluated a number of petitions over the past several years for the DEA on reclassifying marijuana from Schedule I to Schedule, and recommended Schedule I each time, said FDA spokeswoman Shelly Burgess.
“Schedule I substances have a high potential for abuse, no accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision,” Burgess wrote in an email about the feds’ reasons for keeping marijuana as a Schedule I drug.
The legal history of marijuana in the United States is very convoluted and confusing.
Many states had varying laws to restrict or outlaw marijuana in the early 20th century. Congress passed a marijuana tax law in 1937 that generally made marijuana illegal nationally, unless a grower got a permit and paid a tax — an act pushed by the pulp paper industry wanting to restrict the use of hemp for paper. In the 1950s, Congress ordered mandatory imprisonment for possession. In 1969, the U.S. Supreme Court ruled that the 1937 law was unconstitutional because anyone paying such a tax would also be self-incriminating because of other anti-marijuana laws. Congress responded the following year with a law that that made marijuana illegal in all circumstances, but removed the mandatory penalties.
So what is Washington’s and Rhode Island’s case to reclassify marijuana as a Schedule II drug?
Gregoire adviser McGill, Dr. Carter, and substance abuse researcher Mitchell Earleywine, an associate professor of psychology at the State University of New York at Albany, outlined the states’ medical arguments in a long report accompanying Gregoire’s and Chaffee’s letter.
- Schedule I Marijuana is less dangerous and deadly than many Schedule II drugs, which can be prescribed. A Chinese mummy dating back to roughly 2500 B.C. was found with traces of ancient cannabis in its tomb.
“In its 4,000 years of documented use, there is no report of death from overdose with cannabis. In contrast, as little as two grams (1/14 of an ounce) of dried opium poppy sap can be a lethal dose in humans,” Carter and five other researchers wrote in the September 2009 issue of the Journal of Opioid Management. Morphine, fentanyl, and hydrocodone are opioids, along with several other drugs including natural opiates extracted from opium poppies.
“I’ve prescribed oxycodone. I’ve prescribed morphine derivatives. By God, morphine is way more addictive than cannabis,” Carter said in an interview.
Chaffee’s and Gregoire’s November request cited a National Academy of Sciences Institute of Medicine report that said: “Marijuana is not, to be sure, a completely benign substance. It is a powerful drug that affects the body and mind in a variety of ways. However, except for the damages caused by smoking, its adverse effects resemble those of many approved medications.”
- Dronobinol — usually sold under the market name of Marinol — is a type of marijuana pill used to combat nausea in chemotherapy patients and anorexia in AIDS patients. In fact, dronobinol is 100 percent THC, which is the chemical in marijuana that affects the brain, resulting in possible changes in perception, mood, and behavior. The feds reclassified dronobinol from Schedule I to Schedule II in 1986, and from Schedule II to Schedule III in 1999 because its extra brain-boggling oomph is unpleasant enough to discourage abuse.
Proponents of reclassifying medical marijuana argue that it is illogical to have the Marinol as a prescribable Schedule III drug while all other forms of marijuana are federally illegal to use medically.
- Marijuana fails to meet federal requirements to be listed as a Schedule I drug: a high potential for abuse when compared to Schedule II drugs, plus a lack of acceptable medcial use.
The state’s report argued that marijuana fits the federal requirements for acceptable medical use because its chemistry is known and easily reproduced, plus there have been sufficient studies vouching for its safety and effective use in medicine. The FDA disagrees. Carter, Earleywine, and McGill also noted that at least 105 clinical trials worldwide have been conducted in the past couple decades with almost all showing positive medical results — with the caveat that trials with positive results are more likely to be published than ones with negative conclusions. “The available medical research indicates that cannabis is highly effective in treating a number of problems commonly encountered in medicine,” Carter, Earleywine and McGill wrote.
- In 2009, the American Medical Association said marijuana should removed from the Schedule I list. Two other medical and research associations, the American College of Physicians in 2008 and the Institute of Medicine in 2003, made similar recommendations.
The 2009 Journal of Opioid Management article noted that roughly 7,000 doctors nationwide authorized marijuana for about 400,000 patients. In 1998 in Washington, the estimate was that 1,000 to 2,000 doctors authorized marijuana for about 25,000 patients.
An authorization from a doctor is different from a prescription. A prescription covers exact amounts and a schedule of taking the medicine. An authorization is essentially a recommendation for a patient to use marijuana, leaving up to that individual to find his or her own source. An authorization legally protects a doctor who is advising a patient to seek marijuana some somewhere. “Interestingly, there is no specification as to how often the patient needs to be seen or exactly how long the authorization is good,” Carter, Earleywine and McGill wrote. Carter later said that not much training is available for physicians to be intimately familiar with marijuana as a prescription drug, saying that shortfall needs to be tackled.
Meanwhile, Carter, Earleywine and McGill have suggested that Washington use pharmacies to distribute marijuana via prescriptions, although numerous details would have to be nailed down.
Gregoire’s and Chaffee’s letter contended that advances in DNA analyses can better pinpoint the best mixes of the beneficial biochemicals within strains of marijuana, which could translate into pharmacists becoming able to tailor the right mixes of cannabinoids to individual patients.
“We know some things,” Carter wrote in an email. “But more research would help determine the best medical strains (i.e., some strains with low THC and high CBD/CBN could give pain relief without making you high).” CBD is a marijuana ingredient that relieves convulsions, anxiety, and nausea as well as slowing the growth of some cancer cells. CBN helps marijuana’s soothing effects move through cells.
Carter added some strains are known to work as pain relief — without making someone high — in small amounts. But more research is needed, he said. Carter and McGill said the FDA can supervise that research and manufacturing, making pharmaceutical marijuana a more precise type of medicine than what is grown in coops.
That’s an extra safeguard that pain-sufferer Hadle sees as a benefit of moving marijuana into the prescription drug system .
The governors’ letter said: “This paradigm would allow safe access to a medicine with proven efficacy and acceptable safety, in a manner that does not endanger the patient and allows for reasonable government oversight. It is important to note that medical cannabis can be vaporized, not smoked. Additionally cannabis can be ingested orally, or applied topically as a liniment.”
Vaporization and ingestion offer additional options for medical marijuana patients, although Hadle said she doesn’t like either of them.
Marijuana smoke is hotter (burning at 392 degrees Fahrenheit) than the increasingly popular vaporization of marijuana at a minimum of 285 degrees and most effectively at 338 degrees. Also, lung-damaging tar is present in marijuana smoke.
Most box-like vaporizers are slightly bigger than palm-sized and can be found in many pipe shops for — wink, wink — “tobacco use only,” along with bongs and other smoking paraphernalia not normally associated with tobacco. Secondary smoke and contact highs are not an issue with vaporizers.
The effects of ingesting medical marijuana within food can last six to seven hours, while the effects of smoking pot usually last three to four hours.
But Hadle prefers smoking over vaporization and eating. To Hadle, vapor does not deliver the pain-killing oomph that smokes does, although she has not tried the more expensive vaporizers in the $200 range yet. And eating marijuana — in brownies for example — doesn’t appeal to Hadle. All she can taste is a dry, straw-like, medicin flavor with a bad aftertaste, nothing that resembles chocolate or food.
However, Hadle’s biggest concern is what goes into her body, which goes to the heart of the benefits of treating marijuana as a prescription drug. She is skittish about going to a marijuana dispensary because of concerns about quality control and dosages.
She grows her own eight plants at home: 12 hours under a heat lamp in a spare room and 12 hours in a dark closet per day. Hadle has a microscope to check her leaves for mold spores. “That’s why I grow my own because the quality control is there,” Hadle said. She experimented until she found a marijuana strain that worked for her.
But Hadle likes the pharmacy model with its quality control, precision, and the abilty to use health insurance to pay for medical marijuana. Whether she makes that step forward depends on the willingness of federal leaders to make the leap in thinking increasingly sought by the states.