October 19, 2012
Law, Policy Thwart Research on Marijuana
By: Chelsea Conaboy
The Boston Globe
Massachusetts voters prepare to vote on whether to allow medical marijuana for people suffering from PTSD, chronic pain, HIV/AIDS, leukemia, and other illnesses, while a lack of adequately controlled scientific studies is fueling disagreements between patients and policymakers over its safety and effectiveness. Meanwhile, the National Institute on Drug Abuse continues to block MAPS’ planned, FDA-approved study of marijuana for symptoms of PTSD in U.S. veterans.
Originally appearing here.
Massachusetts voters in 2½ weeks will consider becoming the 17th state to legalize the use of marijuana for medical purposes. But there is little research showing whether the drug has therapeutic benefits.
That says more about the difficulty of studying an illegal substance than it does about the inherent medical value of the plant.
Opponents of the proposal say medical practice should be defined by rigorous study and drugs vetted by the US Food and Drug Administration, not by popular opinion. Advocates say federal drug policy has thwarted that process. They point to abundant anecdotes and a collection of small studies that found marijuana to be effective in alleviating pain and muscle stiffness in people with chronic conditions.
Ethan Ruby has no doubt that marijuana is medicine. The 37-year-old, who grew up in Southeastern Massachusetts, was struck by a drunk driver in a Manhattan crosswalk 12 years ago. He has no feeling below his chest except for persistent pain in his legs.
To cope, Ruby relies on a small dose of marijuana, sometimes several times a day. The drug distracts him from the pain long enough to focus on his business pursuits or to spend good-quality time with his wife and two children, he said. It allowed him to cut his use of prescription narcotic painkillers from daily to occasional.
For some doctors in the state, though, such examples are not enough.
“For any other drug, there has got to be testing,” said Dr. Joseph Gravel, chief medical officer of the Greater Lawrence Family Health Center and president of the Massachusetts Academy of Family Physicians
The Massachusetts Medical Society opposes the referendum, but sent a letter to the US Drug Enforcement Administration this month urging that marijuana be reclassified to make it easier to research.
Use of a ballot question to determine medical practice is worrisome, Gravel said, as is promotion of a drug that is typically smoked. He and others said the more responsible path would be to develop drugs derived from components of marijuana, the way morphine is derived from opium.
One drug already on the market, Marinol, uses synthetic tetrahydrocannabinol, or THC, to treat nausea in people undergoing chemotherapy. But doctors interviewed for this report said its effect is limited, and researchers suspect that marijuana components interact for greater effects than THC alone.
Individual doctors and patient advocacy groups, including the AIDS Action Committee of Massachusetts and the state chapter of the Leukemia and Lymphoma Society, have endorsed the ballot question, saying marijuana can help patients and is available now.
There is ample anecdotal evidence to support the idea, said Dr. Eric Ruby, Ethan’s father and a Taunton pediatrician who has become a vocal advocate for the Massachusetts proposal.
“We haven’t done the studies because [the drug is] illegal,” he said. “Because it’s illegal, we can’t do the studies. That’s not scientific. That’s circular.”
To study marijuana, researchers must be licensed by the US Drug Enforcement Administration and get access to marijuana grown at the University of Mississippi, which contracts with the National Institute on Drug Abuse to produce the only federally sanctioned supply. That process can prove onerous, if not impossible, acting as a deterrent for those who might want to study marijuana’s benefits, some researchers said.
In 2000, the University of California created the Center for Medicinal Cannabis Research, with $9 million from the state. The state’s blessing and the university’s reputation helped to secure federal approvals, said Dr. Igor Grant, the center’s director, who is based in San Diego. In the past decade, he and colleagues have completed the most comprehensive research to date of the effects of marijuana in patients, including studies that were randomized and double-blind, gold standards in research.
Four studies found the drug to be useful in treating pain. Three were in patients with HIV who had pain resulting from damage to their nervous system. Another study found that marijuana reduced muscle stiffness in patients with multiple sclerosis. But the studies were small, each involving dozens of patients rather than the hundreds or thousands needed to advance the drug toward federal approval.
“What’s surprised us, actually, was the consistency of the evidence,” Grant said.
The next step would be to pursue large trials and to compare smoked and vaporized marijuana with approved drugs. But Grant’s center has reached the end of its funding, with no more promised from the state.
Proponents of medical marijuana have donated money for research to the Multidisciplinary Association for Psychedelic Studies, a nonprofit focused largely on medical use of ecstasy and marijuana. But executive director Rick Doblin of Cambridge said he and colleagues have repeatedly been denied access to the marijuana grown at the University of Mississippi.
The group’s latest application, to study the effects of marijuana in a small group of veterans with posttraumatic stress disorder, was turned down by a federal Health and Human Services review panel that evaluates privately funded studies of marijuana. The panel determined in September 2011 that the study design was not scientifically sound, a conclusion that Doblin disputes.
Researchers should not have “to go to the agency whose mission is [promoting] what’s wrong with illegal drugs — which is [the National Institute on Drug Abuse] — to find out what’s right with marijuana,” he said.
Lyle Craker, a professor of horticulture at the University of Massachusetts specializing in medicinal plants, has worked with Doblin since 2001 to establish a second production facility where he could grow marijuana in the controlled setting that research requires.
The Drug Enforcement Administration denied Craker’s application for a facility license in 2009. Craker is appealing the decision in federal court.
Steven Gust, special assistant to the director of the National Institute on Drug Abuse, said there has been little demand from researchers to use the Mississippi supply.
“The fact of the matter is that there is no blocking of research of potential medical benefits of marijuana,” he said.
While he expects pharmaceutical companies to develop medications related to marijuana, Gust said the smoked drug has little chance of gaining approval from federal regulators.
Eric McCoy of Boston said he needs the drug now, and the Massachusetts ballot question will make it easier for him to get it. The 59-year-old began using marijuana about 17 years ago, shortly after he was diagnosed with multiple sclerosis. Like Ruby, McCoy uses a vaporizer that heats the plant, rather than burning it, and is meant to limit the inhalation of toxins.
He uses a scooter to get around outside his condominium. But McCoy said marijuana alleviates stiffness in his arms and legs, allowing him to navigate his home using handrails and live on his own.
“It allows me to take care of myself,” McCoy said. “I get up and do what I have to do to live life everyday.”
Grant said patients should have access to the drug while pharmaceutical companies work to develop better medications.
“There’s some evidence that marijuana might help,” he said. “Why deny that to the patient?”
Worried about what being caught with the drug would mean for his professional life and his family, Ruby recently moved from New York, where marijuana is illegal, to Colorado, where voters approved medical use 12 years ago.
Now, he is planning to create an organic marijuana distribution center to cater to patients like himself who are educated about the drug and have genuine needs. He said he believes it is only a matter of time before all states have legalized medical marijuana.
“We’re begging for it to be regulated and taxed,” he said.
Grant said the patchwork of state laws approved so far concerns him. He worries that storefront marijuana distribution is poorly controlled. He would rather see a federal plan that regulates the supply and potency of the drug, he said. That requires more research and a change in federal drug law, which now considers marijuana to have “no currently accepted medical use.”
“There’s no question it can have harmful potential,” Grant said. “But it’s not useless.”
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