Monday, November 21, 2011

The Gaps in Medical Marijuana Knowledge

COMMENT
Taking into account that this is an interview with a researcher searching for money to continue his work, the gist of this article is: “There is no safe supply. To me, this should be supplied in pharmacies under a doctor’s prescription and carefully controlled like codeine or morphine or anything else that’s a substance that could be addictive.”
Marijuana has been around for centuries and, in fact, wasn’t illegal in this country until the 1930s. Isn’t it extraordinary that, with all this history it still hasn’t been scientifically evaluated to the satisfaction of the medical community? Does this ring an alarm bell in your mind about the medical efficacy of the drug?
Pot advocates pushed through an initiative and convinced the public it would treat people terminally ill who had exhausted alternatives to pain relief. Slowly, a for-profit industry took shape, probing the loopholes in the law. Meanwhile, the drug was becoming much, much more powerful than the junk most Americans, including the writer, had a few experiences with as youngsters.
Then, thanks largely to an interpretation of the initiative by then-Attorney General Jerry Brown, it became a runaway, uncontrolled industry making billions in profits and selling to anyone who convinces one of the many medical whores writing “recommendation” letters, that he has a sore back or “anxiety”. If you stand in front of the typical marijuana store (I refuse to call them “collectives” or “cooperatives”), you see a parade of healthy looking men under 35 getting their “medication”. The going rate, by the way, is 200 bucks an ounce.
It’s a total farce, and I applaud the Federal authorities for taking action after the lilly-livered local politicians punted. Someday, we may see marijuana as a drug prescribed for specific problems. For now, I’m going to relieve my pain with gin.

OFF THE WIRE
University of California, San Diego psychiatry professor Dr. Igor Grant is director of the state-funded Center for Medicinal Cannabis Research.

His main focus is the effect of AIDS on the brain, but University of California, San Diego psychiatry professor Dr. Igor Grant rarely gets calls from the media about that topic. Instead, he hears from reporters who want to know about pot and pain.
Grant is director of the state-funded Center for Medicinal Cannabis Research, which has spent 11 years and $8.7 million studying the use of marijuana to treat pain. It's produced five studies suggesting that pot indeed has value as a painkiller and as a treatment for symptoms of multiple sclerosis; two more studies are due next year. A total of about 300 patients have taken part.
But now, the money is running out. As of next year, the center will exist in name only unless someone steps in to provide funding.
It's not the end of the road for Grant, a Canadian native who will continue other kinds of research. But he says we'll still have huge gaps in knowledge about marijuana because of the overwhelming challenges facing those who might dare to study it. At the moment, no other researchers in the country appear to be studying medical marijuana.
But the battle over medical marijuana continues. In California, prosecutors are targeting dispensaries in San Diego and elsewhere, while the largest physician group in the state just came out in favor of pot's legalization and regulation.
In an interview, Grant talked about what we've learned about marijuana's powers, how it stacks up against existing medications and why research into pot is going down the tubes.
Why study marijuana when there are so many medications to handle the conditions it's said to treat, like nerve pain, anxiety and cancer-related nausea?
Why do we need another antibiotic, another sleeping pill or antidepressant? The answer is, in part, because not everybody responds favorably to the drugs we have available.
The reason isn't that pot is wonderful. It's that if it works, it's an alternative for some patients who aren't benefiting from traditional treatments.
Neuropathic pain is a good example. It's chronic pain that involves pain and burning, especially in the hands and feet. It's a hypersensitivity that people with AIDS, diabetes and other diseases have, and it can be really uncomfortable and disabling.
We do have medicines for neuropathic pain, but they're only partially effective. Some people get a good result, while others get no result or a partial result. And some people can't tolerate particular medications.
It's always nice to have something else that you can offer a person.
Do you have trouble getting marijuana?
No, because all of our work was reviewed by the federal government, and they are the only legal supplier of marijuana. They actually have a farm at the University of Mississippi that produces marijuana for research purposes, and there are even a few patients that are part of an old program who can still get marijuana from the federal government.
The general way the studies are done is through placebo control. (These are studies that randomly assign patients to receive marijuana or a placebo.) They can fabricate a dummy marijuana: it has the hemp in it, but not the active ingredient, so it smells and tastes the same, makes people cough just as much and so forth, but doesn't have the psychoactive effects.
What kind of effect does marijuana have on pain compared to other painkillers?
Marijuana fits in the middle in terms of neuropathic pain. It is probably not as good as certain antidepressants, but it is just as good as some of these antiepileptic drugs, and it may be better than a few others.
It's probably about as effective as existing medications: it isn't that much better or that much worse. It's an alternative.
When you finish everything next year, what do you think the message of your research will be?
I'm quite surprised at the findings. As a skeptic, I thought we'd do this research and get six of one, half a dozen of the other — we'll have some studies that say yes and some that say no.
In fact, every single study has been positive, which is a surprise to me. Now, they're not large in scope, so you could always criticize them. But they suggest to me that there's something to this.
To the idea of marijuana as medicine?
Absolutely.
Will it ever be possible for marijuana to treat pain but not make people high?
In the case of pain, it's actually difficult to disentangle the pain relief from the emotional components of pain. An argument could be made that if you're a person with terminal cancer, maybe it's OK to blunt your mood or change your mood in a certain direction.
The anti-anxiety and anti-pain effect work together to produce a positive action. On the other hand, if you have pain and you're a truck driver, you certainly don't want to be driving stoned.
The studies must raise questions about whether patients realize they have the real marijuana because it has a big effect on them.
You can blind the participants to some degree, but not perfectly. If you give a potent enough dose of the real marijuana, they'll know what hit them.
That's true of pretty much any drug that has an effect on the brain. If you were doing a trial of a tranquilizer like Valium, people will know they're on something.
There's really no way to blind that, unless you give them something else that makes them feel high, but what's the point of that?
Do some patients in your studies feel an effect on their pain from the fake marijuana?
A good number of people, about a third or more, think they're getting the active drug when they're getting the placebo.
As a group, the placebo do not do as well. We've shown that there is a positive effect of marijuana, on neuropathic pain particularly, that's over and above the placebo effect.
What happens next year when the final studies come out? Are you done?
Pretty much. We go out of business in terms of funding any more research. We still exist, so if funding comes along in the future, we can do more work.
But at the moment, we have no expectations, considering the economics of the state. I don't see where the funding would come from at this point.
What do you think of the way the debate over medical marijuana shops has played out?
It's really unfortunate on many levels. To me, it reflects a real dysfunction, a huge tension in our society about substances of abuse and recreational drug use.
With marijuana, what has happened is that because the subject is so polarized, people are so worried about drug abuse and cartels. What's been lost in the shuffle is the patient and the fact that this may be something useful.
What about the supply of marijuana for patients?
There's no safe supply. To me, this should be supplied in pharmacies under a doctor's prescription and carefully controlled like codeine or morphine or anything else that's a substance that could be addictive. But that's not the situation.
I worry about patients who are recommended marijuana: Do they know what they're getting, the quality, the potency? Are there adulterants? It's not a good situation.
There's a sense that you could go to one of these doctors, say you have a hangnail, and get a medical marijuana card. I've never seen anyone actually prove that doctors are allowing just about anybody to get a card, but there's that perception. What do you think of that?
I don't know what the facts are, but I do know that if this was regulated like a legitimate medicine, you'd have a lot better control of it.
We do know that even medicines that are well-regulated are abused. But it arguably is the case is that we have a better sense of the control of the substances than something that is outside the system.
Medications must go through three phases of research in humans before the FDA approves them for use by the general public. Has marijuana even gotten to Phase I?
Our trials were sort of Phase II-ish trials. What you need now is Phase III trials, and I would say there's enough preliminary evidence. What we do not know is how different populations will react.
For example, we haven't studied old people, people like me. The effects could be different. We haven't studied other kinds of complications, like heart disease, and we haven't had a really great balance of ethnic composition. People in some racial groups may metabolize the drug differently or respond differently.
This is what you find out in Phase III trials when you have larger groups. You can also see what the side effects are.
But I don't foresee this kind of research anytime soon. There would have to be a change in federal policy.
What does the public misunderstand about medical marijuana?
There is this conflation of concerns about abuse and control of drugs of abuse and the medical aspect. There's been a failure to separate it.
Apparently, the head of the Office of National Drug Control Policy said, well, one reason we are not treating marijuana any differently before is that there's no evidence that it's medically useful; the FDA hasn't approved it, the National Institutes of Health haven't opined on it, or something like that.
That ignores the body of evidence that's emerging. There's also a circularity there: if you effectively don't permit the research to happen, you can't have an opinion that it works.
It's not the case that the federal government has stopped the research. But by having marijuana it in Schedule I — basically dangerous drugs that are useless — it makes it extremely difficult to do the studies.
Here, we have the benefit of a state-funded center to help researchers navigate the very complicated regulatory framework, which involves going to the National Institutes of Health, Health and Human Services, Food and Drug Administration, Drug Enforcement Administration, not only in Washington but locally. They come and say, "Where do you store marijuana? Is your safe bolted to the concrete floor?"
Who in their right mind, other than in a state-funded center like ours, is going to say they're going to research medical marijuana when there's all this controversy and they'll be tarred with "Dr. Pot" or something like that?
If you ask somebody on the federal level, "Are you blocking research?," they'd say no: legitimate people can do research. But the practicalities are very, very complicated. Until we can get past that, until it can be researched like other medicines, fairly easily, we aren't going to get any more innovation.
Please contact Randy Dotinga directly at randydotinga@gmail.com and follow him on Twitter: twitter.com/rdotinga.