Thursday, December 1, 2011

The Cornerstone of American Drug Policy

The Cornerstone of American Drug Policy

The cornerstone of American drug policy is the Controlled Substances Act of 1970, and the cornerstone of that act is the scheduling scheme.  That act divides controlled substances into five categories, or schedules.  Drugs in Schedule I, which include marijuana, heroin, LSD, peyote, and MDMA among others, may not be manufactured, distributed, or possessed by anyone. The definition of Schedule I drugs is therefore the cornerstone of the scheduling process.

To be classified in Schedule I, a drug must have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and cannot be used safely under medical supervision.  None of these three primitives are defined in the act and have not been clarified by the courts.  But the problematic element is the second.  What is “currently accepted medical use in treatment in the United States”?

Two meanings of this phrase are possible.  The first is to treat the language as requiring the DEA to look into the actual medical efficacy of the drug as shown by medical science.  This meaning has been followed by the Drug Enforcement Agency in proceedings to reschedule marijuana and MDMA since 1972. The courts have never examined this definition, all but one of the appeals on marijuana having been decided on procedural grounds.  Even in original NORML case, the court never reached the substantive issues.

The second possible meaning is that the issue is strictly one of demographics.  Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients.  In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.

An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law.  That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.

That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice.  The government began prosecuting doctors who furnished morphine or heroin   for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.

The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”.  In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA.  However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient.  So far the DEA has not presented the issue to another circuit.

Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the1930s.  The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.

Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner.  A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.

That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved.  The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses.  Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA.  The most recent case, Gonzales v. Oregon (2005), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.

A determination of "efficacy" seems very close to determining medical utility - since efficacy seems to imply "effective in treating a disease" "relieving symptoms" "boosting health functions" etc. What is the difference?

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug.  The statutory language itself reinforces this interpretation.  The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations.  Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases.  In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”.  The Court of Appeals (Grinspoon, First Circuit,1987)  rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument.  Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs.  But for that classification, their medical use would probably be common today.  Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems.  This information would be probative in a rescheduling action.  If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.

Since the passage of the CSA medical use of marijuana has blossomed even while forbidden.  Thousands of refereed medical papers have been published,  its effectiveness. Sixteen jurisdictions have enacted medical marijuana laws, and well over a million patients now regularly use medical marijuana under those laws.  The undercover illegal use by patients in other states could easily double that total.

Marijuana has now met the statutory requirements that necessitate its removal from the absolute prohibition of Schedule I.  It has been shown to be qualified as a drug available for a doctor’s prescription just like OxyCotin, cocaine, and methamphetamine. All that is necessary is for the DEA to apply the law as written.

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