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April 15, 2013

Is there any sound scientific reason for the dearth of marijuana research funding?

The question in the title of this post is prompted by this lengthy and informative new Bloomberg article, which is headlined "Marijuana Research Funding Cut as Support for Drug Grows."  Here are excerpts:

As more states embrace legalized marijuana, the drug’s growing medicinal use has highlighted a disturbing fact for doctors: scant research exists to support marijuana’s health benefits.

Smoked, eaten or brewed as a tea, marijuana has been used as a medication for centuries, including in the U.S., where Eli Lilly & Co. (LLY) sold it until 1915.  The drug was declared illegal in 1937, though its long history has provided ample anecdotal evidence of the plant’s potential medicinal use.  Still, modern scientific studies are lacking.

Subsequent research suggests marijuana may help stimulate appetite in chemotherapy and AIDS patients, help improve muscle spasms in multiple sclerosis patients, mitigate nerve pain in patients with HIV-related nerve damage and reduce depression and anxiety.

What’s more, the federal government is scaling back its research funding. U.S. spending has dropped 31 percent since 2007 when it peaked at $131 million, according to a National Institutes of Health research database.  Last year, 235 projects received $91 million of public funds, according to NIH data.

That’s left the medical community in a bind: current literature on the effects of medical cannabis is contradictory at best, providing little guidance for prescribing doctors.  “What’s happening in the states is not related to science at all,” said Beau Kilmer, co-director of RAND Corp.’s drug policy research center. Kilmer is also part of a group selected to advise the state of Washington on its legalization effort. “It’s difficult to get good information,” he said.

Two states, Washington and Colorado, have fully legalized the drug, 18 states allow its use for medical reasons and 17, including New York, have legislation pending to legalize it.

Donald Vereen, a former adviser to the last three directors of the National Institute on Drug Abuse, says that most doctors’ and policy makers’ knowledge on the subject stems from a 1999 report from the Institute of Medicine, an independent nonprofit that serves to provide information about health science for the government.  The group summed up its findings saying cannabis appeared to have benefits, though the drug’s role was unclear.

The IOM report recommended clinical trials of cannabinoid drugs for anxiety reduction, appetite stimulation, nausea reduction and pain relief. It also found that the brain develops tolerance to marijuana though the withdrawal symptoms are “mild compared to opiates and benzodiazapines.”... Vereen, for one, says marijuana’s effects on pain without the withdrawal symptoms associated with other medications are deserving of further study to develop better pain drugs.

Subsequent research suggests marijuana may help stimulate appetite in chemotherapy and AIDS patients, help improve muscle spasms in multiple sclerosis patients, mitigate nerve pain in those with HIV-related nerve damage and reduce depression and anxiety. It’s even been suggested that an active ingredient, THC, may prevent plaques in the brain associated with Alzheimer’s, according to a 2006 study by the Scripps Research Institute.

Still, fewer than 20 randomized controlled trials, the gold standard for clinical research, involving only about 300 patients have been conducted on smoked marijuana over the last 35 years, according to the American Medical Association, the U.S.’s largest doctor group....

Until more laws change, it will be difficult to study an illegal substance with the goal of turning it into a medication, researchers say. And since it’s illegal to grow, marijuana isn’t subjected to the rigorous quality control most medicines are, raising concerns patients may be at risk from contaminants, said Vereen.

Marijuana advocates point out inherent obstacles to conducting research: the National Institute on Drug Abuse controls all the cannabis used in approved trials, but the agency’s mandate is to study abuse of drugs, not health benefits. FDA Dilemma This creates dilemmas. The Food and Drug Administration, for instance, has approved a clinical trial studying whether marijuana can relieve symptoms of post-traumatic stress disorder. The trial, however, which is in the second of three stages of clinical testing, is blocked. NIDA, which controls the legal testing supply of the drug grown at a University of Mississippi farm, has refused to supply the researchers with marijuana.

“NIDA is under a mandate from Congress to find problems with marijuana,” said Bob Melamede, CEO of Cannabis Science Inc. (CBIS), a Colorado Springs, Colorado-based company that develops medicines derived from marijuana. “If you want to run a study to show it cures cancer, they will not provide you with marijuana,” he said. “What you cannot do are the clinical studies that are necessary.”

Attempts to expand licensed facilities beyond the University of Mississippi farm, have been denied, including a petition from University of Massachusetts agronomist Lyle Craker. The Drug Enforcement Administration denied that request in 2011, reversing a 2007 recommendation from its own administrative law judge, Mary Ellen Bittner.

NIDA also administered the most projects from 2003 to 2012, overseeing $713 million split among 1,837 research efforts. The bulk of the funding in the past decade was devoted to evaluating marijuana’s risks, potential negative impacts on the brain and developing prevention and treatment strategies, according to NIDA.

“There’s been a significant amount of study, but not clinical research,” said Brad Burge, a spokesman for the Multidisciplinary Association for Psychedelic Studies, a non-profit research and advocacy group. What’s lacking, says Burge, is “research intended to move marijuana, the plant, through the path to prescription approval by the FDA.”

For now, the research that does exist is often contradictory. A survey of 4,400 people found that those who consumed marijuana daily or at least once a week reported less depressed mood than non-users, according to a 2005 report in the journal Addictive Behaviors. A 2010, however, study in the American Journal of Drug and Alcohol Abuse of 14,000 found that anxiety and mood disorders were more common in those who smoked almost every day or daily....

Doctors’ attitudes are also shifting in favor of easing marijuana restrictions. The American Medical Association, the nation’s biggest doctor organization has called for a review of marijuana’s Schedule I status, a designation that declares it has no accepted medical use.

The American College of Physicians, the second-largest U.S. doctor organization with 133,000 members, also wants criminal penalties waived for doctors who prescribe marijuana and patients who smoke it. The drug could be useful to treat multiple sclerosis, nausea and pain, based on preliminary studies and pre-clinical lab work, the group said in a 2008 position paper calling for more research.

April 15, 2013 at 09:58 AM | Permalink

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Comments

There can never be a sound reason for willful ignorance.

Posted by: 8th Amendment | Apr 15, 2013 4:34:15 PM

8th:

When you can be sent to prison for the manufacture, distribution and admininistration of the clinical drug(s), and there is no guaranteed patentable drug or device to recoup the the costs of clinical trials, anyone who would study the drug and related compounds even in initial animal toxicological studies is insane.

Since the original source of the drug(s) is the government, its identity, strength, quality and purity are unknown and would need to be carefully characterized. In addition, the means of reproducible drug quantification and dosage administration would need to be explored and defined. Cigarettes and smoking are terrible methods for a reproducible and quantifiable drug delivery device and the most suitable means of drug administration are unclear.

Just the prep work for the new compound(s) (THC and/or related compounds) would take several years for any meaningful clinical studies to begin, i.e., minimum effective dose and maximum tolerated dose determinations in both animals and people.

I cannot see anyone who knows how to develop drugs taking a project like this with its risks (legal) and limited potential benefits (financial and patent). We may never know!

The problems mostly stem from the illegality of the drug(s) and studying them. Even with government approvals, they would come with caveats that I am sure would make rounding errors of insignificant numbers punishable by our legal system.

I hoped I bored you as much as Bill does.

Posted by: albeed | Apr 15, 2013 10:57:45 PM

"When you can be sent to prison for the manufacture, distribution and admininistration of the clinical drug(s).....I cannot see anyone who knows how to develop drugs taking a project like this with its risks (legal)"


Exactly, albeed. That's what puts the "willful" in willful ignorance.

As a country, through our laws, "we" have engaged in willful ignorance of any possible pharmaceutical benefits this plant could provide.

Prohibiting scientific research = CHOOSING to remain ignorant.

Posted by: 8thAmendment | Apr 16, 2013 1:55:06 PM

8th:

I agree with you. Willful ignorance is an epidemic sweeping this country. It is amazing how much of this comes from the bowels of our government.

Posted by: albeed | Apr 17, 2013 8:29:20 AM

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