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Sun Jan 8, 2012, 08:58 PM

Dr. Lester Grinspoon: On The Pharmaceuticalization of Marijuana

Dr. Grinspoon, a medical doctor and professor of psychology at Harvard, has long been on the front lines fighting the propaganda war against cannabis. His initial response to cannabis, as a professor who saw so many students using marijuana in the 60s, was to study it to show them the harm. Instead, he became a courageous spokesperson for the use of cannabis in both medical and personal life. He has real world experience with the use of cannabis medicine through his son's chemo treatment for leukemia.

The following article was published in the International Journal of Drug Policy, 12 (5-6) (2001) pp. 377 - 383.

http://www.rxmarijuana.com/Pharmaceuticalization.htm

Abstract: Given the very limited toxicity of marijuana and the growing appreciation of its therapeutic value, it will undoubtedly find increasing application as a medicine in the coming years. But there is uncertainty about the forms in which it will be made available. Governments are hesitant to approve it because of concern about its use for nonmedical purposes and the difficulties of distributing as a medicine a substance that is already easily available. An alternative is the development of commercial cannabis pharmaceuticals that can be regulated and controlled. But pharmaceutical firms will be reluctant to invest the necessary money if they believe they cannot compete successfully with marijuana. Some of these products may have advantages over whole smoked or ingested marijuana, but most will not, and they will all be quite expensive. Ultimately, we can anticipate two medical distribution networks, a legal one for cannabinoid pharmaceuticals and an illegal one for street or homegrown marijuana


Under public pressure to acknowledge the medical potential of marijuana, the then director of the Office of National Drug Policy, Barry McCaffrey, authorized a review by the Institute of Medicine of the National Academy of Science which was published in March of 1997 (Joy et al. 1999). The report acknowledged the medical value of marijuana, but begrudgingly. One of the report's most important shortcomings was its failure to put into perspective the vast anecdotal evidence of marijuana's striking medicinal versatility and limited toxicity. The report states that smoking marijuana is too dangerous a form of delivery, but this conclusion is based on an exaggerated evaluation of the toxicity of the smoke. The IOM would have patients who find cannabis helpful when taken through the respiratory system wait for years until a means of delivering smoke-free cannabinoids is developed. But there are already prototype vaporizers which take advantage of the fact that cannabinoids vaporize at a temperature below the ignition point of dried cannabis plant material. The report's Recommendation Six would allow patients with what it calls "debilitating symptoms (such as intractable pain or vomiting)" to use smoked marijuana for only six months, and then only after all other approved medicines have failed and the treatment is carefully monitored with "an oversight strategy comparable to an institutional review board process." (Joy et al. 1999: 7-8). This makes legal use of medicinal cannabis practically impossible. The authors of the report are treating marijuana as if it were a drug like thalidomide, with well-established serious toxicity (phocomelia) and limited clinical usefulness (leprosy). This is inappropriate and unworkable for a drug with limited toxicity, unusual clinical versatility, and easy availability. At least the IOM Report confirms that even government officials no longer doubt that cannabis has medical uses. Inevitably, cannabinoids will be allowed to compete with other medicines in the treatment of a variety of symptoms and conditions; the only uncertainty involves the form in which they will be delivered.


Dr. Grinspoon goes on to note that he assumed, after studying cannabis for decades, that all that is necessary to make it possible to allow U.S. citizens to utilize this "useful and benign" (according to the DEA's own judge, Francis Young) plant-based medicine would be to have the DEA reschedule marijuana. Now, he says, this assumption was wrong.


Today, transferring marijuana to Schedule II (high potential for abuse, limited medical use) would not be enough to make it available as a prescription drug. Such drugs must undergo rigorous, expensive, and time-consuming tests before they are approved by the Food and Drug Administration (FDA). This system is designed to regulate the commercial distribution of drug company products and protect the public against false or misleading claims about their efficacy and safety. The drug is generally a single synthetic chemical that a pharmaceutical company has developed and patented. The company submits an application to the FDA and tests it first for safety in animals and then for clinical safety and efficacy. The company must present evidence from double-blind controlled studies showing that the drug is more effective than a placebo and as effective as available drugs. The cost of this evaluation exceeds 200 million dollars per drug. Case reports, expert opinion, and clinical experience are not considered sufficient.


It is unlikely that whole smoked marijuana should or will ever be developed as an officially recognized medicine via this route. The extensive government-supported effort of the last three decades to establish a sufficient level of toxicity to support prohibition has instead provided a record of marijuana's safety that is more compelling than that of many, if not most, approved medicines, while thousands of years of medical use have demonstrated its value. The modern FDA protocol is not the only way to establish a risk-benefit estimate for a drug with such a long history. To impose this protocol on cannabis would be like making the same demand of aspirin, which was accepted as a medicine more than 60 years before the advent of the double-blind controlled study. Many years of experience have shown us that aspirin has many uses and limited toxicity. Even if we thought that this experience was insufficient to establish its credentials by modern standards, it would not be possible to marshal it through the FDA approval process. The patent has long since expired, and with it the enormous economic incentive to underwrite the cost of this modern seal of approval. The plant cannabis too cannot be patented, so the only source of funding for a "start-from-scratch" approval would be the government, which is, to put it mildly, unlikely to be helpful. Other reasons for doubting that marijuana would ever be officially approved are today's anti-smoking climate and, most important, the widespread use of cannabis for purposes disapproved by the government.


It appears, then, that in the United States two powerful forces are colliding over the issue of medicinal cannabis. On the one hand, there is a growing interest in and acceptance of the medicinal importance of cannabis, and there is every reason to believe that this development will continue to gain momentum. As it does so it increasingly confronts the proscription against any use of marijuana. At the same time, there does not appear to be widespread interest in moving from an absolute prohibition against cannabis to a regulatory system which would allow for the responsible use of this drug. The federal government, until recently has denied any medical utility to cannabis, and it appears to be vehemently opposed to any relaxation of the prohibition.


We see this issue is being played out in the U.S. at this time with the issue of Sativex's planned entry into the U.S. drug market compared to the federal govt's continued insistence that marijuana has no medical value.

The only way to undo the harm of the drug war is for the federal government to decriminalize cannabis entirely and remove it from the drug schedules.

We have massive civil disobedience at this time as millions ignore the propaganda of the drug warriors, just as we saw during alcohol prohibition.

The refusal to accept the medical value of whole-plant cannabis will continue to burden Americans with prescription drug prices that are beyond the reach of many, while criminalizing their actions to mitigate the effects of chemo, epilepsy, migraines, HIV drugs, CP, MS, rheumatoid arthritis and alzheimers via affordable practices.

And so, America continues a class and drug war on its people, no matter which political party is in office. I thought we were better than that. Apparently not.

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