Tidbits on Drug Policy

Another two cents thrown in

What does it take to prove medicinal value?

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According to the statute, the substances listed in Schedule I (Title 21, Volume 9, Section 1308.11 of the Code of Federal Regulations) have “no currently accepted medical use in treatment in the United States.” 21 USC Sec. 812.

What exactly constitutes “accepted medical use in treatment in the United State” under the statute can be argued; however many people have already concluded that a bunch of substances that are currently placed in Schedule I actually do have medicinal value. There are not many people in this country who are not aware about the raging debate about medicinal properties of marijuana, and it is an open secret that plenty of oncologists across the country have been recommending it to their patients as treatment for nausea and vomiting resulting from chemotherapy. Indeed, that would likely satisfy Judge Young’s “significant minority of physicians” test in determining what constitutes “accepted medical use.” In The Matter Of MARIJUANA RESCHEDULING PETITION, US DoJ DEA, Docket No. 86-22 (overruled by the DEA Adminstrator).

But, I got distracted here.

There are actually other Schedule I substances that appear to have medicinal properties. One of them is psilocybin, an active ingredient in magic mushrooms and LSD that appears to help cluster headache sufferers. Fred Reed wrote an article about psilocybin being used as a treatment for cluster headaches, obviously by cluster headache sufferers themselves. The reason why it caught my attention is because way back in college, a friend of mine actually suffered from cluster headaches and cured himself with a low doze of “shrooms.” From what I know about cluster headaches, the condition is so painful that sufferers have been known to literally bang their heads against walls. A low dose of magic mushrooms or LSD (a dose that is not sufficient to induce hallucinogenic effects) is claimed to be effective in aborting the cluster headache episode that’s in progress and extending remission periods. In his article, Fred Reed asks:

“When a seriously painful medical condition is cured by an illegal substance, the cure being substantiated by premier researchers at as good a medical institution as exists, what do we do?”

Source: Washington Times: When the Law Can Be Painful

Well, here’s what is generally done:

“Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.

The DEA also may begin an investigation of a drug at any time based upon information received from law enforcement laboratories, state and local law enforcement and regulatory agencies, or other sources of information.

Once the DEA has collected the necessary data, the DEA Administrator, by authority of the Attorney General, requests from HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control. This request is sent to the Assistant Secretary of Health of HHS. Then, HHS solicits information from the Commissioner of the Food and Drug Administration and evaluations and recommendations from the National Institute on Drug Abuse and, on occasion, from the scientific and medical community at large. The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be placed.

The medical and scientific evaluations are binding to the DEA with respect to scientific and medical matters. The recommendation on scheduling is binding only to the extent that if HHS recommends that the substance not be controlled, the DEA may not control the substance. (Italics Added).”

Source: Wikipedia: Controlled Substances Act

For example, a recently-approved study aiming to evaluate the efficacy of MDMA (Ecstasy) in treatment of post-traumatic stress disorder first had to get the FDA approval, then had to get approved by an Institutional Review Board (IRB) (because it involves research with human subjects) and, finally, had to obtain DEA approval, since it involves a Schedule I substance. If the study actually confirms therapeutic value of MDMA, would that mean that Ecstasy will be moved from Shedule I? I am not sure, but one article that I found suggests that it will:

“If Ecstasy proves to be an effective and safe treatment for post-traumatic stress disorder, therapists can sign legal prescriptions for the drug.”

Source: Wired: DEA Accedes to Ecstasy Test

Getting back to psilocybin, shrooms, LSD and cluster headaches, the good news is that a study of psilocybin and LSD in people with episodic cluster headaches is currently being developed. The bad news is that it will probably take years to clear all bureaucratic hurdles.

Generally, I believe that many substances currently listed in Schedule I have medicinal properties – albeit unknown to medical science in its current state. The dangers (or the perceived dangers) of these substances got them into Schedule I in the first place. It would be nice if the reports of possible medical benefits of these substances actually induced FDA, DEA and HHS to assume a more proactive stance in investigating these benefits. After all, the medical science would certainly benefit from having another tool added to to its arsenal of treatments.

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