Fri October 12, 2012
Feds To Debate Marijuana As Medicine
Originally published on Fri October 12, 2012 11:45 am
IRA FLATOW, HOST:
Next Tuesday, marijuana will have its day in court because the United States Court of Appeals is set to hear arguments about the drug's therapeutic and medicinal effects. But some doctors, like one of my next guests, disagrees with the government's ban on medical use of marijuana, pointing to the drug's ability to suppress nausea, stimulate the appetite, relieve pain, improve sleep, even fight cancer cells, in test tubes at least.
Is the science on cannabis compelling enough to convince federal officials? And have we done the rigorous science on marijuana that's required of all drugs to get it to your pharmacy? Dr. Donald Abrams is chief of oncology at San Francisco General Hospital. He's also a professor of medicine at the University of California in San Francisco. He joins us by phone. Welcome to SCIENCE FRIDAY, Dr. Abrams.
DR. DONALD ABRAMS: Thank you, good to be here.
FLATOW: You're welcome. Dr. Bertha Madras is professor of psychology - psychobiology, I'm sorry, in the Department of Psychiatry at Harvard Med School in Southborough, Massachusetts. She joins us by phone. Welcome to SCIENCE FRIDAY.
DR. BERTHA MADRAS: Thank you, good afternoon.
FLATOW: Good afternoon to you. Dr. Abrams, do you think it's time? Do you think the evidence is there that the federal government should OK cannabis for general use?
ABRAMS: Well, I mean, let's take a step back. Cannabis was on the formulary of the United States until 1942, when it was removed. So cannabis, which has been a medicine for thousands of years in other parts of the world, was available in this country, again, until '42, when it was taken off our pharmacopoeia. So yes, I think that the Institute of Medicine in their last report in 1999 suggested that cannabis and cannabinoids, their active components, have use in treatment of nausea, vomiting, pain and loss of appetite.
And as a cancer doctor, I see patients every day, people who are benefiting from the use of cannabis. The problem is the government does not allow cannabis to be studied as a therapeutic agent because the only legal source is the National Institute on Drug Abuse, and they have a congressional mandate only to study substances' abuse, as substances of abuse. So that's a bit of a catch-22.
FLATOW: Dr. Madras, would you agree with that?
MADRAS: Frankly I disagree, and here are my reasons why. Number one is, yes, marijuana was removed from the pharmacopeia in the late 1930s, in fact, but because it was found that the safety and efficacy issues did not reach the bar that was necessary for drug approval.
The fact that Dr. Abrams claims that we cannot study cannabis in scientific studies is disingenuous because the Center for Medicinal Cannabis Research, of which he's a part of, in California, has conducted and has received millions of dollars from the California Legislature to study smoked marijuana as a medicine.
And as of today, I have looked at their site. They have precisely four published manuscripts on the medicinal uses of cannabis for which the Proposition 15 approved marijuana and a number of other publications that bear no relationship to these clinical trials.
So the clinical trials can go on. The marijuana is available for them. Cannabinoids are being studied and synthesized at horrendously large rates by medicinal chemists, and yet...
FLATOW: I have to interrupt you. We'll get back to you, Dr. Madras. We have to take a break. Stay with us. Also Dr. Abrams, we'll be right back after this break. I'm Ira Flatow, this is SCIENCE FRIDAY from NPR.
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FLATOW: This is SCIENCE FRIDAY. I'm Ira Flatow. We're talking this hour about legalization of cannabis and the use of cannabis, otherwise marijuana, in research studies. When I interrupted Dr. Bertha Madras, she was talking about the fact that there were lots of studies in California and plenty of samples of cannabis to get if you needed to study it. Dr. Abrams, how do you answer that?
ABRAMS: Yeah, so the Center for Medicinal Cannabis Research was set up in California for that reason, to fund studies to look at the potential effectiveness of cannabis. And I did two, one that demonstrated in patients with HIV infection and painful nerve damage, cannabis was better than placebo in relieving their pain.
And I also did a study funded actually by NIDA because it was a safety study to show that it was safe for patients on chronic opiates to add cannabis to their regimen. It did not change the level of opiates in their bloodstream, and if anything, it may have improved their pain relief.
FLATOW: So you think there's enough evidence, then, that the courts should approve it?
ABRAMS: Well, no, you know, again, evidence, that's what I'm saying. It's difficult to do clinical trials looking at cannabis as a therapy because of the catch-22 that NIDA, you know, is preferentially supplying their cannabis to studies that look at its danger.
So the evidence, you know, clinically the evidence is there, and I do disagree that the reason that it was removed from the pharmacopeia, the American Medical Association in 1937, after the introduction of the Cannabis Tax Act, was - stood alone in saying that there is no evidence that cannabis is dangerous and that this act would impede the ability to research it for its effectiveness.
And then it was removed from the pharmacopeia and subjected to Schedule 1, and, you know, the main target in this country's failed war on drugs.
FLATOW: So you think there are not enough resources to conduct the clinical studies that would be needed?
ABRAMS: Well, not many people want to study cannabis. It's sort of a difficult thing in your career because, you know, I think the more - science is not driving the train, that's what I'll say. I mean, the more evidence that people accumulate - we now have three studies demonstrating cannabis' utility in peripheral neuropathy, which is a very challenging medical condition to treat.
Oftentimes people are put on opiates, and then their life is one string of opiates after another. Better - cannabis, this is a flower we're talking about it. It's a flower. It's not a dangerous substance like the opiates that I prescribe and others prescribe for patients living with cancer and pain.
FLATOW: Dr. Madras, would you acknowledge that cannabis and cannabinoids have some therapeutic effects like Dr. Abrams mentioned?
MADRAS: I acknowledge that cannabinoids may have some therapeutic effects. I disagree with Dr. Abrams vehemently on the thought that one's hands are tied in doing the science. Once again, the Centers for Medicinal Cannabis...
ABRAMS: Oh don't repeat yourself on that, that's silly.
MADRAS: Had all money available to do with - and they have...
ABRAMS: Three million dollars a year for three years.
MADRAS: But let me please finish. They had to cancel five studies because they could not recruit enough patients. One of the criteria for recruiting patients is that they had to be experienced marijuana users. How many elderly cancer patients in this day and age are experienced marijuana users? They also were not allowed to drive because there was fear of liability in case they got into a car accident because they were under the influence.
So there were - so what Dr. Abrams should say is that there was money, there was cannabis available for the studies. Why did five of the major studies that they had proposed at the onset of this program, why were they canceled?
FLATOW: Dr. Abrams, any answer?
ABRAMS: Well, I mean, you know, again, all of my studies were done in the in-patient clinical research center so we could observe the patients and make sure they weren't diverting this Schedule 1 substance. And cancer patients, I don't think, are that enthusiastic about spending, you know, some of the remaining days of their lives in the hospital doing a research study.
Plus there was always a concern that the cannabis that NIDA provides is not particularly potent and that because we live in California, where we've had cannabis available as a medicine for patients since 1996, if patients really wanted to use it, they could.
And as a cancer doctor, ma'am, many patients in my age group, who grew up in the '60s and '70s, with cancer are cannabis-experienced people. So that is not a problem. The problem is the closing of the dispensaries now by the federal government in California, when we voted for it in 1996, is not allowing my elderly patients access to their medicine.
MADRAS: And NIDA provides marijuana cigarettes at 3.5 and seven percent THC. Do you think that you need more than that, especially considering one of the studies that came out of the CMCR that said that at seven percent the side effects were quite above the boundary of acceptable side effects, meaning psychoactive dizziness, confusion and so on?
So my feeling is that the doses that are available for this research are in fact available, but once you get into seven percent or six percent cannabis, you do have side effects that have to be reported in clinical trials, far beyond that boundary of what are...
ABRAMS: Yeah. Again, I hate to disagree with you, but the cannabis available in dispensaries averages from 10 to 15 percent, and legal cannabis in The Netherlands is 14 percent that you get from the pharmacy. So three and seven percent is not a huge amount, and I think patients need to self-titrate.
It's very different from other medicines, you know, where you tell the patient try it and see what works for you. You know, if it...
MADRAS: But that's not how the FDA works.
ABRAMS: Well, of course not. This is not...
MADRAS: The FDA requires and insists that one does a window of therapeutic efficacy compared with a window of a side effect profile that may render a drug unacceptable in the market. And if you do a full-dose response curve, you will find that past a certain percentage of THC, a person is quite incompetent.
ABRAMS: Well, that's absolutely correct, same with alcohol. You know, I mean, I personally believe that this is a flower, and it should be regulated like tobacco or alcohol. And, you know, trying to get FDA approval for a medicine that's been a medicine for thousands of years and was on the U.S. pharmacopeia until 1942, when it was removed by an act of Congress submitted by a racist - you know, what are we doing in this country? This is a flower. We're spending $4 billion a year on the war on drugs and incarcerating 180,000 Americans.
MADRAS: Well, you know, ephedrine from the ma huang plant...
ABRAMS: Oh, you could give me all the examples you want. I'm not in favor of cocaine, either.
MADRAS: Pardon? Most of our medications, at least 30 percent, are originally derived from plants.
MADRAS: The active ingredients were isolated, such as cocaine, such as digitalis, such as aspirin, such as morphine. They were isolated. They were studied in isolation in order to determine how fast they get into the brain, how fast they get into the blood...
ABRAMS: That's the Western pharmaceutically dominated paradigm, you know...
MADRAS: And also what the...
FLATOW: I'm going to jump in here. I'm going to jump in, and I'm going to ask...
ABRAMS: There are thousands of years of research where people use the whole plant as medicine.
FLATOW: Dr. Abrams, do you think it's possible to create studies that would satisfy the FDA requirements?
ABRAMS: I'm sorry, I do not. I continue to do this work, but I don't think that this is going to happen in my lifetime unless other people start looking at the ridiculousness of our current policies in this country. I'm sorry.
FLATOW: Ridiculous meaning what?
ABRAMS: Well, this is a flower. You know, I grew up in the '60s and '70s. I went to Brown University and Stanford University School of Medicine. Cannabis was my substance of choice, not alcohol. And I'm very happy with the person that I've become today, and I would be very different if alcohol was what I used for relaxation.
FLATOW: Dr. Madras, have you done studies on cannabis?
MADRAS: I have done a few limited studies on isolated cannabinoids, not in patients, in preclinical research. I have studied the literature extensively because I am very interested in the scientific issues, not as much the political issues.
FLATOW: Well, do you believe that the studies can be done...
ABRAMS: Science does not drive the politics here, though, that's for sure.
MADRAS: I believe...
FLATOW: Dr. Madras, do you believe that studies can be done that would satisfy the FDA?
MADRAS: I certainly do.
ABRAMS: Oh, my goodness.
MADRAS: I think that...
FLATOW: And who would do them?
MADRAS: Well, Sativex...
ABRAMS: Good question.
MADRAS: ...and I have no, you know, full disclosure, I have absolutely no outside funding from any sources.
FLATOW: So who should do this? Who should get the funding to do this?
MADRAS: So drug companies are - GW Pharmaceuticals in England, they've approved an inhaled form of...
ABRAMS: It's not inhaled, dear. It's sprayed under the tongue.
MADRAS: ...THC combined with cannabidiol, which does not have psychoactive effects but therapeutic effects and different types of formularies that can deliver a reasonable bolus of active...
FLATOW: Well, Great Britain...
MADRAS: ...ingredients to the brain would satisfy the FDA. At this point, the real issue is the relationship between psychoactive effects and therapeutic effects. The faster a drug gets into the brain, the more addictive it has - the more...
ABRAMS: No. Don't start with addictive.
MADRAS: ...addictive potential and the more its psychoactive effects. And this is the problem with a substance such as marijuana smoke. The other issue is: Do we want smoked marijuana as a delivery system for medications? It has between 60 and 80 cannabinoids in it of uneven quantities because every one produces different ratios...
MADRAS: ...of all of them.
FLATOW: I have to stop you from filibustering. Let me get another question in here. Dr. Abrams, for people who already have problems, health problems, what about the smoking issue? Isn't smoking a bad solution?
ABRAMS: Yeah. My friend and colleague Donald Tashkin at the University of California, Los Angeles has spent 40 years of his career doing studies for NIDA looking for the danger of inhaling cannabis and basically finds that chronic users may have a little bronchitis. Actually, it appears from his piece de resistance study of 1,365 patients with aerodigestive malignancies in Los Angeles that regular cannabis use decreased the risk of lung cancer. A recent study in young people followed for 20 years show that those who regularly use cannabis had better pulmonary function tests than those who didn't.
So there are other ways to deliver cannabis than smoking, and we've investigated a vaporizer, and vaporization is now widely used by patients here in California as a smokeless delivery system. But in my opinion, smoking is not that dangerous, either, and I'm sure that will get some disagreement from my colleague.
FLATOW: A lot of people think that it's the high that you get from smoking marijuana that is the therapeutic effect. Is that correct?
ABRAMS: I think that the cannabinoids - we have two receptors in our bodies, the CB1, which is in the brain, and the CB2, which is in the immune system. And the activation of these receptors causes chemical reactions in cells which have many different effects besides the psychoactivity. As my colleague said, another cannabinoid, cannabidiol is very potently analgesic and anti-inflammatory without being psychoactive. So the concern that there's 60 or 70 other cannabinoids in the plant is exactly something, I think, is a good thing.
As a student of traditional Chinese medicine, a medicine that's been practiced for 5,000 years, they frequently use the whole plant instead of following the Western pharmaceutically industry-dominated paradigm of isolating the active component, make it into a pill that people swallow and charging large amounts of money. So I think that the cannabinoids, as well as the other components of the plant - terpenoids and flavonoids - all have the potential for medical benefits.
FLATOW: All right. Let me remind everybody that this is SCIENCE FRIDAY from NPR. Let me ask you, Dr. Madras, one more time, do you think there are studies that can be done in the United States that would convince the FDA, and who would do them?
MADRAS: I think there are studies. I think we have to, A, alter the delivery system to remove smoke. Marijuana smoke has ammonia up to 20 times greater than tobacco smoke. It has hydrogen cyanide and nitric oxide and some aromatic amines that are three to five times higher in marijuana than tobacco smoke. And there are many other problems associated with marijuana smoke. So what are the criteria? One should change the method of delivery...
FLATOW: Who will do...
MADRAS: ...and also - let me just finish...
FLATOW: Who will do the study? Ma'am. Ma'am, who will do the study?
MADRAS: ...change the method of delivery as well as study and...
FLATOW: Dr. Madras, who will...
MADRAS: ...focus on single cannabinoids.
FLATOW: Dr. Madras, who will do these studies?
MADRAS: Well, there are pharmaceutical companies that are quite interested in...
FLATOW: Have they - will they...
ABRAMS: It's a flower. Nobody can patent a flower.
FLATOW: Will they...
ABRAMS: Nobody can patent a flower. They're not going to make any money.
FLATOW: Who's going to...
MADRAS: They can patent methods of delivery. They can patent single isolated cannabinoids. They can patent...
ABRAMS: And they've done that. We have that on the market.
MADRAS: They can patent...
ABRAMS: That's called dronabinol and nabilone. Those are available for patients. I'll tell you, as a cancer doctor, I'm...
MADRAS: Yes. Generic drugs are very, very lucrative for companies such as Teva Pharmaceuticals. They can be made as generics as well.
FLATOW: Who will? Can is a large population. Who is doing it and will do it and pay for it?
ABRAMS: Can I - there's no answer to that, so I can just say as a cancer doctor now for 30 years in a state where we have tolerance to the use of cannabis as medicine, that a day doesn't go by when I don't see a cancer patient who has nausea, loss of appetite, pain, depression and insomnia. And I could recommend one medicine to that patient and instead of writing prescriptions for five or six different pharmaceuticals that may interact with each other or with the patient's chemotherapy. And this is a medicine that my cancer patients can grow if they want to.
I ask all of my patients: What brings you joy? And the percentage of people living and, in fact, dying with cancer who tell me gardening brings them joy is not insubstantial because bringing life out of the ground is a pleasure. And if this life that people bring out of the ground is also their medicine, why don't we let them have it? The number of patients who come to me saying they were given narcotics and at - they're at the end of life and they can't communicate with their family, and then they wean themselves off of their opiates with cannabis so that they could have a more pleasurable interaction in their final days of life. Why do we deny people this medicine?
MADRAS: Well, why is it that the recommendations currently are that serotonin 5-HT3 antagonists are much better at preventing chemotherapy-induced nausea than marijuana?
ABRAMS: Yeah, I'm not saying - it's not a question about ranking, but I think...
MADRAS: Why is that there are so many alternatives now to smoking marijuana, sending the wrong message to kids...
ABRAMS: I hope you never have to repeat chemotherapy.
MADRAS: ...than what you're claiming? I'm afraid...
ABRAMS: Right. But what about Melissa Etheridge? She's the one that went public, saying she could not have tolerated her chemotherapy for her breast cancer if she didn't use cannabis. We have many medicines, but if they don't work and cannabis does, why deprive people of their medicine?
FLATOW: All right. I have to stop it right there. Dr. Bertha Madras, professor of psychobiology at the Department of Psychiatry at Harvard. Dr. Donald Abrams, chief of oncology, San Francisco General Hospital. Thank you both for taking time to be with us.
FLATOW: We're going to take a break. After the break, tracking the ozone hole. It's not just over Antarctic anymore. Stay with us. I'm Ira Flatow. This is SCIENCE FRIDAY from NPR. Transcript provided by NPR, Copyright NPR.