Scientists, FDA at odds over benefits of marijuana

Biology professor Robert Melamede is almost manic as he preaches the virtues of medical marijuana. He spews scientific jargon as he discusses the “thousands” of studies that prove it’s one of the greatest drugs in modern medicine.”In my mind, it’s the first thing you should use, not the last,” he says. “We’ve had it backwards.”

On the other side is the U.S. Food and Drug Administration, which declared in 2006 that “no sound scientific studies supported medical use of marijuana treatment in the United States.”

In those two extremes lies the problem. At a time when more than a dozen states have legalized marijuana for medicinal use and at least two others are considering it, just how useful marijuana is as medicine remains largely a mystery. Major clinical research into the drug has been stymied by politics and controversy. And the known facts about marijuana are often laced with spin and emotion from the two sides that Melamede and the FDA represent.

Physicians and scientists familiar with marijuana’s medicinal uses generally agree that the drug has at least some benefits for some patients. In 1999, the Institute of Medicine, home to some of the world’s top scientists, acknowledged the drug’s potential and called for more research into it. The American Medical Association has taken a similar position.

But measured responses to marijuana are often lost amid the emotions of advocacy or condemnation.

Cannabis cheered

Melamede, who teaches at the University of Colorado at Colorado Springs, can quote studies on marijuana like a preacher quotes the Bible. He is both a scholar and a patient on the state’s registry, and he says the drug has the potential to benefit almost everyone: stroke patients, cancer patients, the mentally ill and possibly even soldiers exposed to chemical warfare.

“For people with strokes, the first thing they should be doing is toking up a joint,” says Melamede, who uses marijuana to treat chronic back pain. And he notes one claim in which marijuana reversed some of the effects of Sarin, a deadly nerve gas, in mice. His latest hypothesis: Eating cannabis could help fight avian and swine flu.

He and other supporters point to patients who have benefited from medical marijuana – including Frank Blakely, who at 60 suffers from cerebral palsy. He also has a degenerative nervous disorder, one working kidney and a pacemaker to correct a slow heartbeat, and he lost his right leg below the knee to antibiotic-resistant bacteria.

“The doctors have given me absolutely no hope of things doing anything but getting worse,” says Blakely, a retired software developer. Marijuana, he says, has helped him reduce his reliance on morphine and oxycodone.

“It doesn’t completely replace the oxycodone or the morphine, but for me it replaces about 75 percent … The part of me that is in pain, it helps divorce me from those parts, whereas the narcotics overwhelm the pain but they overwhelm me in the process. With the number of medicines I take, everything is contraindicated, and it’s good to have a medicine without side effects.”

Searching for science

But animal studies, anecdotes and the bulk of existing research don’t measure up to the standards of clinical trials, which drive drug approvals and treatments. For pharmaceuticals, mice may be the beginning, but the end is usually a set of extensive human trials with rigorous controls and procedures to ensure other factors don’t taint results. In many instances, what proves true for lab rats doesn’t pan out for humans.

“There’s research. But it’s crappy research,” says Dr. Randall J. Bjork, a Colorado Springs neurologist who is one of more than 600 Colorado doctors who will certify patients to use medical marijuana. “It would be nice to see something definitive printed up in the New England Journal of Medicine or Annals of Neurology.”

He said his marijuana-using patients do seem more able to manage their conditions than do many other patients. He sees them just once a year, when it’s time to re-certify them for the registry. And he’s intrigued by reports from other doctors, such as a Prague physician who claimed two-thirds of his Parkinson’s disease patients have improved on marijuana.

Yet Bjork remains skeptical of the effectiveness of a drug that has yet to be tested in large-scale, well-organized studies. For now, he considers marijuana a low-tier treatment and has never suggested marijuana to a patient who wasn’t already inquiring about it.

Pot and pain

Dr. Igor Grant would disagree that all research into medicinal marijuana is shoddy. He runs the University of California at San Diego’s Center for Medicinal Cannabis Research, established after California became the first state to legalize marijuana for medicinal use in 1996.

Four controlled human studies at Grant’s center, led by different researchers at different campuses, found marijuana was effective in treating certain types of pain. Three of them explored the use of marijuana to relieve neuropathy, a type of pain associated with a number of conditions, in AIDS patients. The fourth evaluated pain relief for healthy volunteers who agreed to have pain induced under the skin.

“I would say that, in general, the size of the statistical effect was about what we see with the other treatments,” he says. He sees the potential for marijuana to be developed into a whole class of medications.

Even so, he acknowledges that clinical research is in its infancy.

A Catch-22

The kind of gold-standard research that Bjork and Grant seek isn’t likely to come soon.

Researchers face regulatory hurdles in obtaining or growing pot, not to mention a lack of funding.

When asked why more people are not doing research like his, Grant jokes: “I’d like you to do a study on a completely useless and dangerous drug.”

Bjork suspects some scholars might be afraid to wade into the controversy.

Melamede is convinced clinical trials would only confirm what early studies have shown, and he’s started a company to raise money to support such research.

“The real tragedy is that nobody does the real science on it,” he says. (source)



Study: Heavy Marijuana Use Doesn’t Damage Brain

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Analysis of Studies Finds Little Effect From Long-Term Use

By Sid Kirchheimer WebMD Medical News

July 1, 2003 — Long-term and even daily marijuana use doesn’t appear to cause permanent brain damage, adding to evidence that it can be a safe and effective treatment for a wide range of diseases, say researchers.

The researchers found only a “very small” impairment in memory and learning among long-term marijuana users. Otherwise, scores on thinking tests were similar to those who don’t smoke marijuana, according to a new analysis of 15 previous studies.

In those studies, some 700 regular marijuana users were compared with 484 non-users on various aspects of brain function — including reaction time, language and motor skills, reasoning ability, memory, and the ability to learn new information.

Surprising Finding

“We were somewhat surprised by our finding, especially since there’s been a controversy for some years on whether long-term cannabis use causes brain damage,” says lead researcher and psychiatrist Igor Grant, MD.

“I suppose we expected to see some differences in people who were heavy users, but in fact the differences were very minimal.”

The marijuana users in those 15 studies — which lasted between three months to more than 13 years — had smoked marijuana several times a week or month or daily. Still, researchers say impairments were less than what is typically found from using alcohol or other drugs.

“All study participants were adults,” says Grant, professor of psychiatry and director of the Center for Medicinal Cannabis Research Center at the University of California, San Diego School of Medicine.

“However, there might be a different set of circumstances to a 12-year-old whose nervous system is still developing.”

Grant’s analysis, published in the July issue of the Journal of the International Neuropsychological Society, comes as many states consider laws allowing marijuana to be used to treat certain medical conditions. Earlier this year, Maryland became the 10th state to allow marijuana use to relieve pain and other symptoms of AIDS, multiple sclerosis, cancer, glaucoma, and other conditions — joining Alaska, Arizona, California, Colorado, Hawaii, Maine, Nevada, Oregon, and Washington.

Medicinal marijuana is available by prescription in the Netherlands and a new marijuana drug is expected to be released in Great Britain later this year. In the U.S. and elsewhere, Marinol, a drug that is a synthetic form of marijuana and contains its active ingredient, THC, is available by prescription to treat loss of appetite associated with weight loss in AIDS patients.

Grant says he did the analysis to help determine long-term toxicity from long-term and frequent marijuana use. His center is currently conducting 11 studies to determine its safety and efficacy in treating several diseases.

“This finding enables us to see a marginal level of safety, if those studies prove that cannabis can be effective,” Grant tells WebMD. “If we barely find this effect in long-term heavy users, then we are unlikely to see deleterious side effects in individuals who receive cannabis for a short time in a medical setting, which would be safer than what is practiced by street users.”

Grant’s findings come as no surprise to Tod Mikuriya, MD, former director of non-classified marijuana research for the National Institute of Mental Health Center for Narcotics and Drug Abuse Studies and author of The Marijuana Medical Handbook: A Guide to Therapeutic Use. He is currently president of the California Cannabis Medical Group, which has treated some 20,000 patients with medicinal marijuana and Marinol.

‘Highly Effective Medicine’

“I just re-published a paper of the first survey for marijuana toxicity done in 1863 by the British government in India that was the most exhaustive medical study of its time in regards to possible difficulties and toxicity of cannabis. And it reached the same conclusion as Grant,” Mikuriya tells WebMD.

“This is merely confirming what was known over 100 years ago, as well as what was learned by various government findings doing similar research — marijuana is not toxic, but it is a highly effective medicine.”

In fact, marijuana was available as a medicinal treatment in the U.S. until the 1930s.

Lester Grinspoon, MD, a retired Harvard Medical School psychiatrist who studied medicinal marijuana use since the 1960s and wrote two books on the topic, says that while Grant’s finding provides more evidence on its safety, “it’s nothing that those of us who have been studying this haven’t known for a very long time.

“Marijuana is a remarkably safe and non-toxic drug that can effectively treat about 30 different conditions,” he tells WebMD. “I predict it will become the aspirin of the 21st century, as more people recognize this.”