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Title: A Doctor's Take on Pot
Source: Scientific American
URL Source: http://blogs.scientificamerican.com ... t-blog/a-doctor-s-take-on-pot/
Published: Aug 23, 2016
Author: Nathaniel P. Morris
Post Date: 2016-08-24 11:14:24 by Deckard
Keywords: None
Views: 8648
Comments: 42

We rarely worry about marijuana. So why is it still a Schedule I drug?

On August 11th, the Drug Enforcement Administration announced its decision to keep marijuana classified as a Schedule I drug. The federal government has historically referred to this category as the “most dangerous” group of substances, including drugs like heroin and bath salts.

As a resident physician specializing in mental health, I can't make much sense of this.

Every day, I talk to patients about substance abuse. Whether evaluating patients in clinic, in the emergency department, or on inpatient units, my colleagues and I screen patients for substance use. It's a vital component of any clinical interview, particularly in mental health care, and helps us understand patients' habits and their risks for medical complications.

During my medical training, I've learned which substances to worry about, and which ones matter less.

Alcohol is usually the first substance I ask about. Many people have seen drinking go wrong, be it a friend making a bad decision or a family member struggling with alcoholism. But clinicians see the worst of this on the front lines.

Intoxicated patients stream into emergency departments after crashing their cars, inhaling their own vomit, or falling into a coma. According to the National Institutes of Health, alcohol-related conditions contributed to more than 1.2 million emergency department visits in 2010. The Centers for Disease Control reports excess alcohol consumption causes roughly 88,000 deaths in the US each year.

And alcohol can be just as frightening when patients stop drinking. Heavy drinkers who don't consume as much as they usually do can go into alcohol withdrawal, ranging from mild tremors to terrifying seizures and death. I've spent much of my residency training so far learning how to treat and recognize complications from alcohol withdrawal.

It's not only alcohol that clinicians worry about. Cocaine can cause heart attacks, kidney failure, and complications during pregnancy like placental abruption. Methamphetamine can trigger an assortment of responses, from hyperthermia to violent agitation to cardiogenic shock. Opioids like morphine can plunge patients into respiratory failure and kill them. Intravenous drug use puts patients at risk for hepatitis, endocarditis, or even brain abscesses.

But, for most health care providers, marijuana is an afterthought.

We don't see cannabis overdoses. We don't order scans for cannabis-related brain abscesses. We don't treat cannabis-induced heart attacks. In medicine, marijuana use is often seen on par with tobacco or caffeine consumption—something we counsel patients about stopping or limiting, but nothing urgent to treat or immediately life-threatening.

The federal government's scheduling of marijuana bears little relationship to actual patient care. The notion that marijuana is more dangerous or prone to abuse than alcohol (not scheduled), cocaine (Schedule II), methamphetamine (Schedule II), or prescription opioids (Schedules II, III, and IV) doesn't reflect what we see in clinical medicine.

This isn't to say marijuana is harmless.

Indeed research suggests it may have deleterious effects on the developing brains of adolescents. Marijuana use has been linked to psychotic symptoms in some individuals. Synthetic marijuana has emerged as a new public health challenge and, in 2012, Congress added many of these toxic compounds as separate entities under the Schedule I category.

According to NPR, Chuck Rosenberg, acting head of the DEA, explained the decision to keep marijuana as a Schedule I drug was based more “on whether marijuana, as determined by the FDA, is a safe and effective medicine."

Regulations have prevented US researchers from answering this question over the last several decades. As written in a recent New  York Times editorial, "the government itself has made it impossible to do the kinds of trials and studies that could produce the evidence that would justify changing the drug's classification."

Yet, according to a 2015 systematic review, studies from around the world suggest cannabis and cannabinoid therapies may help patients in a number of ways. These include treating chronic pain, muscle spasms, debilitating side effects of chemotherapy like nausea, and weight loss from HIV infection. Dozens of US states have listened to such findings in recent years and passed legislation approving the use of medical marijuana.

Despite keeping marijuana as a Schedule I substance, the Obama administration has promised to expand national research into the drug. This is a welcome change, and we'll hopefully develop deeper insights into the risks and the benefits of cannabis use.

In the meantime, our nation’s substance policies should be grounded in the realities of clinical practice.

In hospitals across the country, patients writhe in agony from alcohol withdrawal, turn violent from crystal meth, and struggle to breathe after overdosing on prescription opioids. These are the cases that keep health care providers on edge. These are the patients we follow closely. When our pagers go off, we hurry to the bedside, give medications, alert security or even begin resuscitation.

With marijuana? Not so much.

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#15. To: Deckard (#0)

On August 11th, the Drug Enforcement Administration announced its decision to keep marijuana classified as a Schedule I drug. The federal government has historically referred to this category as the “most dangerous” group of substances, including drugs like heroin and bath salts.

What DEA really announce: HHS, not DEA, evaluates for medical use. An international treaty requires maintaining marijuana as a scheduled drug. Congress established only one schedule, schedule I, for drugs of abuse with “no currently accepted medical use in treatment in the United States” and “lack of accepted safety for use under medical supervision.” 21 U.S.C. 812(b).

In accordance with the CSA scheduling provisions, after gathering the necessary data, DEA requested a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services (HHS). HHS concluded that marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision. Therefore, HHS recommended that marijuana remain in schedule I. The scientific and medical evaluation and scheduling recommendation that HHS submitted to DEA is attached hereto. Based on the HHS evaluation and all other relevant data, DEA has concluded that there is no substantial evidence that marijuana should be removed from schedule I. A document prepared by DEA addressing these materials in detail also is attached hereto. In short, marijuana continues to meet the criteria for schedule I control under the CSA because:

1) Marijuana has a high potential for abuse. The HHS evaluation and the additional data gathered by DEA show that marijuana has a high potential for abuse.

2) Marijuana has no currently accepted medical use in treatment in the United States. Based on the established five-part test for making such determination, marijuana has no ‘‘currently accepted medical use’’ because: As detailed in the HHS evaluation, the drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.

3) Marijuana lacks accepted safety for use under medical supervision. At present, there are no U.S. Food and Drug Administration (FDA)-approved marijuana products, nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication. The HHS evaluation states that marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.

The statutory mandate of 21 U.S.C. 812(b) is dispositive. Congress established only one schedule, schedule I, for drugs of abuse with “no currently accepted medical use in treatment in the United States” and “lack of accepted safety for use under medical supervision.” 21 U.S.C. 812(b).

Although the HHS evaluation and all other relevant data lead to the conclusion that marijuana must remain in schedule I, it should also be noted that, in view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II. This is explained in detail in the accompanying document titled "Preliminary Note Regarding Treaty Considerations."

Accordingly, and as set forth in detail in the accompanying HHS and DEA documents, there is no statutory basis under the CSA for DEA to grant your petition to initiate rulemaking proceedings to reschedule marijuana. Your petition is, therefore, hereby denied.

- - - - - - - - - - - - - - - - - - - -

Preliminary Note Regarding Treaty Considerations

As the Controlled Substances Act (CSA) recognizes, the United States is a party to the Single Convention on Narcotic Drugs, 1961 (referred to here as the Single Convention or the treaty). 21 U.S.C. 801(7). Parties to the Single Convention are obligated to maintain various control provisions related to the drugs that are covered by the treaty. Many of the provisions of the CSA were enacted by Congress for the specific purpose of ensuring U.S. compliance with the treaty. Among these is a scheduling provision, 21 U.S.C. 811(d)(1). Section 811(d)(1) provides that, where a drug is subject to control under the Single Convention, the DEA Administrator (by delegation from the Attorney General) must “issue an order controlling such drug under the schedule he deems most appropriate to carry out such [treaty] obligations, without regard to the findings required by [21 U.S.C. 811(a) or 812(b)] and without regard to the procedures prescribed by [21 U.S.C. 811(a) and (b)].”

Marijuana is a drug listed in the Single Convention. The Single Convention uses the term “cannabis” to refer to marijuana. [1] Thus, the DEA Administrator is obligated under section 811(d) to control marijuana in the schedule that he deems most appropriate to carry out the U.S. obligations under the Single Convention. It has been established in prior marijuana rescheduling proceedings that placement of marijuana in either schedule I or schedule II of the CSA is “necessary as well as sufficient to satisfy our international obligations” under the Single Convention. NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977). As the United States Court of Appeals for the D.C. Circuit has stated, “several requirements imposed by the Single Convention would not be met if cannabis and cannabis resin were placed in CSA schedule III, IV, or V.” [2] Id. Therefore, in accordance with section 811(d)(1), DEA must place marijuana in either schedule I or schedule II. Because schedules I and II are the only possible schedules in which marijuana may be placed, for purposes of evaluating this scheduling petition, it is essential to understand the differences between the criteria for placement of a substance in schedule I and those for placement in schedule II. These criteria are set forth in 21 U.S.C. 812(b)(1) and (b)(2), respectively. As indicated therein, substances in both schedule I and schedule II share the characteristic of “a high potential for abuse.” Where the distinction lies is that schedule I drugs have “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use of the drug . . . under medical supervision,” while schedule II drugs do have “a currently accepted medical use in treatment in the United States.” [3]

Accordingly, in view of section 811(d)(1), this scheduling petition turns on whether marijuana has a currently accepted medical use in treatment in the United States. If it does not, DEA must, pursuant to section 811(d), deny the petition and keep marijuana in schedule I.

As indicated, where section 811(d)(1) applies to a drug that is the subject of a rescheduling petition, the DEA Administrator must issue an order controlling the drug under the schedule he deems most appropriate to carry out United States obligations under the Single Convention, without regard to the findings required by sections 811(a) or 812(b) and without regard to the procedures prescribed by sections 811(a) and (b). Thus, since the only determinative issue in evaluating the present scheduling petition is whether marijuana has a currently accepted medical use in treatment in the United States, DEA need not consider the findings of sections 811(a) or 812(b) that have no bearing on that determination, and DEA likewise need not follow the procedures prescribed by sections 811(a) and (b) with respect to such irrelevant findings. Specifically, DEA need not evaluate the relative abuse potential of marijuana or the relative extent to which abuse of marijuana may lead to physical or psychological dependence.

As explained below, the medical and scientific evaluation and scheduling recommendation issued by the Secretary of Health and Human Services concludes that marijuana has no currently accepted medical use in treatment in the United States, and the DEA Administrator likewise so concludes. For the reasons just indicated, no further analysis beyond this consideration is required. Nonetheless, because of the widespread public interest in understanding all the facts relating to the harms associated with marijuana, DEA is publishing here the entire medical and scientific analysis and scheduling evaluation issued by the Secretary, as well as DEA's additional analysis.

__________

[1] Under the Single Convention, “'cannabis plant' means any plant of the genus Cannabis.” Article 1(c). The Single Convention defines “cannabis” to include “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated.” Article 1(b). This definition of “cannabis” under the Single Convention is slightly less inclusive than the CSA definition of “marihuana,” which includes all parts of the cannabis plant except for the mature stalks, sterilized seeds, oil from the seeds, and certain derivatives thereof. See 21 U.S.C. § 802(16). Cannabis and cannabis resin are included in the list of drugs in Schedule I and Schedule IV of the Single Convention. In contrast to the CSA, the drugs listed in Schedule IV of the Single Convention are also listed in Schedule I of the Single Convention and are subject to the same controls as Schedule I drugs as well as additional controls. Article 2, par. 5

[2] The Court further stated: “For example, [article 31 paragraph 4 of the Single Convention] requires import and export permits that would not be obtained if the substances were placed in CSA schedules III through V. In addition, the quota and [recordkeeping] requirements of Articles 19 through 21 of the Single Convention would be satisfied only by placing the substances in CSA schedule I or II.” Id. n. 71 (internal citations omitted).

[3] As DEA has stated in evaluating prior marijuana rescheduling petitions, “Congress established only one schedule, schedule I, for drugs of abuse with 'no currently accepted medical use in treatment in the United States' and 'lack of accepted safety for use . . . under medical supervision.' 21 USC 812(b).” 76 FR 40552 (2011); 66 FR 20038 (2001).

nolu chan  posted on  2016-08-24   16:56:33 ET  Reply   Untrace   Trace   Private Reply  


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