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Pew: Marijuana Science Still Half-Baked

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"Right now, the science doesn't support" re-scheduling marijuana.

Mark Pew

Mark Pew

That is the new final answer from the FDA, DEA and NIDA as announced on Aug. 11.

Twitter blew up.

There were quite a few articles written that provided context (and I've underlined keywords that provide an insight into the author's potential bias).

"U.S. affirms its prohibition on medical marijuana," from the Washington Post: "The government refused again Thursday to allow the use of marijuana for medical purposes, reaffirming its conclusion that the drug’s therapeutic value has not been proved scientifically and defying a growing clamor to legalize it for the treatment of a variety of conditions."

"DEA decision keeps major restrictions in place on marijuana research," from STAT: "Federal drug enforcement authorities announced Thursday that they would continue defining marijuana as a drug with a high potential for abuse and no accepted medical value, a decision that keeps in place significant restrictions on biomedical research."

Gupta: "DEA's missed opportunity on medical marijuana," on CNN.com: "Will this decision make it significantly easier for scientists to study the medical benefits of marijuana? The answer sadly is: unlikely. And this is a missed opportunity that could further delay potential therapies to countless people."

"DEA Rejects Attempt to Loosen Federal Restrictions on Marijuana," by NPR: "Drug Enforcement Administration chief Chuck Rosenberg says the decision is rooted in science. Rosenberg gave 'enormous weight' to conclusions by the Food and Drug Administration that marijuana has 'no currently accepted medical use in treatment in the United States,' and by some measures, it remains highly vulnerable to abuse as the most commonly used illicit drug across the nation.' (I couldn't find any bias as it just reported the news; what a novel concept.)

As I had blogged about on April 8 ("A Federal Decision on Marijuana"), the DEA had told Congress they would make a decision on rescheduling by July. So while a little delayed, they ultimately have made that decision.

The Federal Register was updated Friday (the letter was sent on July 19) with the DEA's separate response to the petitions of Ms. Raimondo and Mr. Inslee (as filed originally by then-Rhode Island Gov. Lincoln D. Chafee and Washington Gov. Christine O. Gregoire on Nov. 30, 2011), and Mr. Krumm (a New Mexico resident, on Dec. 17, 2009) to reschedule marijuana. The content is essentially the same in both letters.

Included is a bevy of supplementary information like treaty considerations (the United Nations' Single Convention on Narcotic Drugs of 1961); pharmacological effects; CNS effects; abuse; studies on some of the "qualifying conditions" set up by states (neuropathic pain, appetite stimulation in HIV, spasticity in multiple sclerosis, asthma, glaucoma); "design challenges for future studies;" and eight factors that helped contribute to the decision. If you really want to know why this decision was made, I suggest you read it.

The 2011 petition suggested three reasons why marijuana should be rescheduled:

  • Cannabis has accepted medical use in the United States.
  • Cannabis is safe for use under medical supervision.
  • Cannabis for medical purposes has a relatively low potential for abuse, especially in comparison with other Schedule II drugs.

And here is the DEA's answer:

"In accordance with the CSA rescheduling provisions, after gathering the necessary data, the DEA requested a scientific and medical evaluation, and scheduling recommendation from the Department of Health and Human Services (HHS). The 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, the HHS recommended that marijuana remain in Schedule I."

In other words, the HHS completely disagreed with the petitioner's assertions.

I thought this was a telling comment attributed to DEA chief Rosenberg: "... while individual researchers may have shown that marijuana or its extracts are helpful for certain conditions, the FDA has the most comprehensive view of the state of scientific research on the drug."

My observation from speaking/writing about this subject since 2013 is that opinions about the medicinal use of cannabis have tended to be highly personal. People know somebody who has received benefit from its use. Studies didn't necessarily matter because in their personal experience, it helped.

But the glass is not half empty.

At the same time, the DEA also announced an expansion of the number of places that grow marijuana for research purposes beyond the current monopoly of the University of Mississippi. This is how the DEA stated it:

"This change illustrates DEA’s commitment to working together with the [Food and Drug Administration] and [National Institute on Drug Abuse] to facilitate research concerning marijuana and its components. DEA currently has 350 individuals registered to conduct research on marijuana and its components. Notably, DEA has approved every application for registration submitted by researchers seeking to use NIDA-supplied marijuana to conduct research that [Health and Human Services] determined to be scientifically meritorious."

That surely is a good thing. If the FDA and NIDA believe the science doesn't prove yet that cannabis is medicinal, then more studies are needed. And one of the ways to produce more (and better) studies is to increase availability.

A blog post by the Brookings Institute's John Hudak (with whom I was a co-panelist in D.C. last month on this subject) is a must read on what this monopoly loosening means. And, interestingly, the fact that re-scheduling wouldn't actually legalize marijuana but only make the statement that it has "medical value."

So is the DEA's decision based on politics or science? The answer to that question is an opinion. What is not an opinion is the gap between the way most states and the federal government see marijuana is not changing any time soon. So keep your seat belts on.

Mark Pew is a senior vice president for workers' compensation medical cost containment provider Prium. This post was republished from Pew's Rx Professor blog on LinkedIn.

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David Pilcher Aug 25, 2016 a 8:08 pm PDT

The DEA has a vested interest in prohibition, as does the criminal justice system, big pharma and law enforcement. The DEA exists for the sole purpose of waging the failed "War on Drugs". Hardly an objective source. "More studies are needed" is bureaucratic code for stalling the march toward legalization because it feeds their machine. It's time to recognize the known therapeutic benefits of an affordable, plant based substance and it's many uses. The fact that Pfizer won't have a patent or the DEA may become obsolete shouldn't be considerations (but maybe they should). Legalize it, release all of the imprisoned non-violent marijuana offenders, expunge their records and restore their rights. It's time.

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