Questions and Answers from Rick Doblin, Ph.D. about the UMass Amherst Project in Response to Jacob Sullum's Reason Article

1. Since the Dutch now sell cannabis in the pharmacy; can you acquire that cannabis for your research instead of NIDA.

Good question! Chemic Labs, which is conducting the vaporizer research for MAPS and CaNORML, has already submitted an application to DEA to import 10 grams from the Dutch Ministry of Health. This is, as you realized, another way of trying to break the NIDA monopoly. However, we'd still be dependent on price and availability to the Dutch. They have so many different varieties available that there is excellent choice of different cannabinoid contents, so that isn't a significant limitation. Still, it would be more politically powerful to force DEA to grant a license to a domestic producer. For now, the short-term battle to break the NIDA monopoly will focus on the request from Chemic to import those 10 grams. So far, we're negotiating with the Senior Drug Policy Advisor to the Secretary of HHS, who says he will make a recommendation to HHS about our request to purchase 10 grams from NIDA, and also to Dept. of Justice about the importation request. It's looking promising as far as a positive recommendation, but what the DEA will do is still unclear.

2. Is the NIDA roadblock a basis for a lawsuit since it only applies to cannabis?

Yes, that's one reason for the lawsuit, that NIDA has a monopoly only on marijuana and is treating marijuana research differently than all other drugs. But the DEA will say that marijuana is treated differently than all other drugs (except coca and opium) in the International treaties. In the case of coca and opium, there are no domestic suppliers but the production still isn't monopolized by NIDA and is able to be imported without NIDA having to approve research protocols.

Steve Fox, Director of Government Relations, Marijuana Policy Project, notes that "the DEA-enforced monopoly is not just wrong, it is illegal. This is what the Code of Federal Regulations provides:

21 C.F.R. 1301.33(b) - "In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion *solely because* a smaller number is capable of producing an adequate and uninterrupted supply."
In other words, the laws governing the licensing of manufacturers of schedule I drugs specifically address the possibility of monopolies and are written so that monopolies do not exist.

We are planning to assist MAPS by sending a letter to the DEA, pointing out their illegal actions. Assuming that fails to produce a desired response, we will be very interested in assisting with any legal actions."

3. Wouldn't hashish be at least as medically effective as cannabis bud and perhaps not have as many unwanted burned particulate matter?

Yes, but most patients who want to grow their own medicine would have a difficult time producing hash from their plants. The key issue is whether the added safety of hashish in reduced particulate matter is so important that research with the bud should be abandoned. Flipping this around, is the added risk of bud over hash clinically important to patients who smoke high-potency bud? Probably not. Our approach to risk-reduction is to work on the development of the vaporizer, which heats but doesn't burn marijuana. Vaporized marijuana has a better safety profile than hash, which still gets burned which is what produces a large number of different undesirable combustion products. Of course, we could move to vaporizing hash, which would have reduced particulate matter as compared to vaporized bud. But the safety advantages aren't likely to be clinically significant and we would then move away from the idea of patients being able, if they choose, to relatively easily produce their medicine.

In future clinical trials, our goal is to test one group that smokes high-potency bud and another that vaporizers the same amount of the bud, then compare safety and efficacy. FDA would clearly prefer to approve vaporizer marijuana over burned marijuana, but we should have data from both conditions so we could demonstrate whether there really is a clinically significant difference in the risks of smoked v. vaporized. If not, we should argue for the approval of smoked marijuana and give patients the option of using the vaporizer if that is their preference.

4. I know that the burning of the cannabis bud produces many different chemical properties and it is in fact the burning which creates said properties but the pure cannabis resin (hashish) should be a more effective medicine.

Hash would be physically safer, to some degree, but I don't think it is likely to be more effective. Also, with the higher cannabinoid content of hash, some patients might be more likely to get higher than they wanted, though this is something that would probably only happen once or twice until these patients figured out how to calibrate their doses.

I one day hope to be able to support your MAPS group with some financial aid.

Thanks! Low income/student membership is just $20 and we're on a membership drive :)

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