DEA Rejects Bid to Reclassify Marijuana: Insists It Has No Accepted Medical Use

There are lots of newspapers reporting that today the DEA denied a petition to reclassify Marijuana from a Schedule I controlled substance (like Heroin)to a lesser schedule. I wish they had taken the time (or figured out how) to access the actual ruling. Nor did the DEA or DOJ put out a news release that I could find.

Here it is, published in today's Federal Register. (Text version here, a faster loading pdf version here.) On the finding that marijuana has no accepted medical use: [More...]

Marijuana has no currently accepted medical use in treatment in the United States: The FDA has not yet approved an NDA for marijuana. The opportunity for scientists to conduct clinical research with marijuana exists under the HHS policy supporting clinical research with botanical marijuana.

While there are INDs for marijuana active at the FDA, marijuana does not have a currently accepted medical use for treatment in the United States, nor does it have an accepted medical use with severe restrictions. A drug has a ‘‘currently accepted medical use’’ if all of the following five elements have been satisfied:

a. The drug’s chemistry is known and reproducible;
b. There are adequate safety studies;
c. There are adequate and well-controlled studies proving efficacy;
d. The drug is accepted by qualified experts; and
e. The scientific evidence is widely available.

[Alliance for Cannabis Therapeutics v. DEA,
15 F.3d 1131, 1135 (D.C. Cir. 1994)]

Although the structures of many cannabinoids found in marijuana have been characterized, a complete scientific analysis of all the chemical components found in marijuana has not been conducted.

A material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts. At this time, it is clear that there is not a consensus of medical opinion concerning medical applications of marijuana.

Finally, the scientific evidence regarding the safety or efficacy of marijuana is typically available only in summarized form, such as in a paper published in the medical literature, rather than in a raw data format. As such, there is no opportunity for adequate scientific scrutiny of whether the data demonstrate safety or efficacy.

....a material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts, even under conditions where its use is severely restricted. To date, research on the medical use of marijuana has not progressed to the point that marijuana can be considered to have a ‘‘currently accepted medical use’’ or a ‘‘currently accepted medical use with severe restrictions.’’

They won't even concede its safe if taken under medical supervision:

If marijuana is to be investigated more widely for medical use, information and data regarding the chemistry, manufacturing, and specifications of marijuana must be developed. Therefore, HHS concludes that, even under medical supervision, marijuana has not been shown at present to have an acceptable level of safety.

So marijuana will remain a Schedule I controlled substance, which means the feds continue to maintain:

A. The drug or other substance has a high potential for abuse.
B. The drug or other substance has no currently accepted medical use in treatment in the United States.
C. There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Update: What about the statements of medical marijuana users attesting to the relief from pain they experience? They don't count.

Scientists call [stories by marijuana users who claim to have been helped by the drug] anecdotes. They do not accept them as reliable proofs. The FDA’s regulations, for example, provide that in deciding whether a new drug is a safe and effective medicine, ‘‘isolated case reports will not be considered.’’ 21 CFR 314.126(e).

Why do scientists consider stories from patients and their doctors to be unreliable? First, sick people are not objective scientific observers, especially when it comes to their own health. [. . .] Second, most of the stories come from people who took marijuana at the same time they took prescription drugs for their symptoms. [. . .] Third, any mind-altering drug that produces euphoria can make a sick person think he feels better. [. . .] Fourth, long-time abusers of marijuana are not immune to illness.

The good news, according to Americans for Safe Access, is now that the DEA has acted to reject the petition, the matter can finally go to a federal court for determination. The timing shows no help can be expected from the Obama Administration:

Notably, the petition denial was sent to legal counsel in the pending lawsuit on June 30th, one day after the Justice Department issued a memorandum to U.S. Attorneys upholding federal threats of criminal prosecution against local and state officials for attempting to pass and implement their own medical marijuana laws. "The federal government is making no bones about its aggressive policy to undermine medical marijuana," said ASA Executive Director Steph Sherer, "And we're prepared to take the Obama Administration to court over it."
And of course there's big pharma dollars involved:
The denial also comes the same week as the International Cannabinoid Research Society (ICRS) is holding its 21st annual symposium in St. Charles, Illinois, just outside of Chicago. The symposium is sponsored in part by an array of pharmaceutical companies, the U.S. National Institute on Drug Abuse (NIDA), and ElSohly Laboratories, Inc., the federal government's only licensed source of research-grade cannabis (marijuana) used in therapeutic studies. Currently, several pharmaceutical companies are asking the government to reschedule organically produced THC, the primary compound found in the marijuana plant, so they can sell a generic version of Marinol®, which is now made synthetically.

Here is the federal lawsuit filed in May in the DC Circuit Court of Appeals to force the DEA to rule on the petition to reclassify. The issue:

Whether the DEA's delay of nearly nine years in providing a substantive response to petitioners' marijuana rescheduling petition-and almost five years after receiving a 41-page memorandum from HHS stating its scientific evaluation and recommendations constitutes unlawful withholding or unreasonable delay of agency action, thereby warranting relief under Section 706(1) of the Administrative Procedure Act and the All Writs Act, 28 U.S.C. § 1651(a).

The original petition is here, and the Americans for Safe Access backgrounder is here.

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  • Display: Sort:
    The FDA (5.00 / 0) (#8)
    by NYShooter on Sat Jul 09, 2011 at 12:02:33 AM EST
    displays the same veracity towards drugs as Moody's does towards securities. They "like" what their paymasters tell them to like. The minute our "reefer madness" President appointed Holder for A.G. our privatized prison system when nuts hi-fiving each other and got busy slipping a few extra dead Presidents into their monthly "contributions" to Congress and the White House.

    Way to go Obama, prick that boil, let all the pus ooze on out. You're on a roll now, S.S., Medicare, Privacy, Wars.....how could we forget a little doobie?

    As with everything else, Congrees will exempt itself from any penalties for tokin a little bone.

    Quick, ban all medicine! (5.00 / 0) (#9)
    by giantslor on Sat Jul 09, 2011 at 02:23:17 AM EST
    "Third, any mind-altering drug that produces euphoria can make a sick person think he feels better."

    Oh no, pot makes people feel better! It must be banned! But wait, aspirin makes people feel better, too. Better ban it just to be sure!

    And what's this about how it "can make a sick person think he feels better"? THINK he feels better? There is no THINKING you feel better. Either you feel better or you don't. Feeling better is a product of the mind. The point is to trick the mind into a feeling of wellness, which is the point of all pain medication.

    A sidenote: Alcohol is a great pain medication. I'm talking physical pain. For me it works better than just about anything. Just don't overdo it or you'll be in a world of hurt the next morning.

    this has nothing to do (5.00 / 1) (#13)
    by cpinva on Sat Jul 09, 2011 at 10:50:48 AM EST
    with safety and efficacy, and everything to do with the benjamins. an entire legal industry has grown up and greatly expanded, based solely on pot being illegal. 1,000's of jobs & billions of revenue/budget dollars, from the judiciary to the penal system, are wholely dependent on keeping it illegal. were pot to be made legal, 50% of all jobs directly/indirectly connected to law enforcement, the judiciary and the penal system would disappear overnite, as they are wholely predicated on the continuing arrest/prosecution/incarceration of pot users/sellers, etc.

    unlike heroin, cocain and similar drugs, pot requires little to no specialized knowledge to produce/process/distribute; any idiot can grow it anywhere in the world, and just pick the buds and leaves off when ready. in the case of those incarcerated for drug violations, the drug in question is pot, for 50% (or more) of them. since drug violaters constitute the majority of those arrested/incarcerated, it requires no math genius to see the disasterous financial effects legalizing pot would have on a host of people.

    the leaders of the international drug cartels and the members of law enforcement share a common goal, to not ever allow pot to be legalized, it would be disasterous for both groups. frankly, i'm surprised the mexican/SA drug cartels and the DEA haven't jointly hired a lobbying firm in DC, to represent their mutual interests to congress.

    Scott over at Grits nails it (5.00 / 0) (#14)
    by Rojas on Sat Jul 09, 2011 at 12:07:40 PM EST
    Drug War has grown "too big to fail"
    By these data, locking up drug users and sellers is a massive market in and of itself that's at least as or more economically significant than illicit drug sales. That $113 billion figure is roughly the same as Bank of America's  2010 gross revenue ($111 billion according to their annual report), for example. If Bank of America is "too big to fail," then so too is the Drug War.

    not "too big to fail", (5.00 / 1) (#17)
    by cpinva on Sat Jul 09, 2011 at 01:47:05 PM EST
    but rather, "too big a part of our economy to get rid of".

    shutting down the "war on drugs" would have as devastating (if not more so) an effect on our finances, as the sub-prime mortgage meltdown had. worse, all we'd have to show for it would be a bunch of empty prisons (possible future condos?), and not even foreclosed houses that might, someday (hopefully before they rot to pieces) be re-sold.


    So sad, so sick, so true... (5.00 / 1) (#19)
    by kdog on Sat Jul 09, 2011 at 02:26:49 PM EST
    a prime example of throwing human beings in a meat grinder to serve an economy, instead of creating an economy to serve human beings.

    Not really (none / 0) (#38)
    by Rojas on Sun Jul 10, 2011 at 09:20:30 AM EST
    Just like our choice with the banks, the short term effect is re-distributive not stimulative. The long term effects are destructive not creative.

    So, we can't have single-payer because (5.00 / 1) (#30)
    by Anne on Sat Jul 09, 2011 at 04:30:19 PM EST
    it would put insurance companies out of business, we can't legalize pot because it would put court personnel, law enforcement personnel, prison employees, etc. out of work, we can't end wars because it would kill the defense contracting industry and our military would be bloated with people being paid to do nothing.

    Jesus, Mary and Joseph - what a complete failure of imagination and inspiration; not sure I have words to describe how pathetic that is.

    Someone please call the Whaaaaambulance...


    yep, (none / 0) (#31)
    by cpinva on Sat Jul 09, 2011 at 05:18:20 PM EST
    pretty much so.

    A total breakdown (none / 0) (#39)
    by Rojas on Sun Jul 10, 2011 at 09:40:56 AM EST
    of cognitive thought by the civil rights generation.

    I agree with their conclusion (none / 0) (#1)
    by andgarden on Fri Jul 08, 2011 at 10:15:18 PM EST
    But that doesn't mean I think it should be illegal.

    their conclusion is horsesh*t (5.00 / 1) (#2)
    by Dadler on Fri Jul 08, 2011 at 10:29:59 PM EST
    They don't know the longterm effects of the majority of drugs that are legally prescribed.  It is puritan hypocrisy, hiding behind lies about science (excuse me, but they know VERY well it works wonders with certain conditions, and they know why, it's mainly about this stuff called THC, but it's just that, and here's the real thing, listen closely...YOU CAN GROW IT YOURSELF AND NOT HAVE TO PAY A PHARMACEUTICAL COMPANY JACK SH*T.  Or a booze outfit.  That these clinics don't have to pay a bigger company crap is why this stuff is illegal.

    No.  Other.  Reason.

    That we give children serious psychotropic drugs by the truckload knowing NOTHING about the long term effects, well, count me as one who can call utter bullsh*t when I see it trying to hide behind science or public safety.

    This is more of the corruption of the government, plain and simple.  


    I find it hard to believe that you fail to understand this as the basic motivation here.  It is like denying our middle east wars are not about oil.

    Do you know how horrible alcohol is on the brain?  Do you know


    heh . . . (5.00 / 2) (#6)
    by nycstray on Fri Jul 08, 2011 at 11:10:32 PM EST
    They don't know the longterm effects of the majority of drugs that are legally prescribed.

    I just imagined a MJ commercial and the FDA list of possible side effects at the end was much shorter than the standard FDA pharma tag ;)

    I wonder what the effects are on your kidney's vs say Tylenol and that family of OTC drugs?

    With the direction they're taking this country, you would think they would prefer us all stoned.


    oops, exnay everything after Corruption. (none / 0) (#3)
    by Dadler on Fri Jul 08, 2011 at 10:31:07 PM EST
    In a hurry.



    Alcohol is not a drug that we pretend (none / 0) (#4)
    by andgarden on Fri Jul 08, 2011 at 10:40:37 PM EST
    has any use in treating disease. MJ is no more a "medicine" than tobacco. It has properties that can be, but that's beside the point. Neither a leaf nor a burning cigarette is an acceptable medicine. You can't guarantee purity, dosage, or safety. More to the point, there is no such thing as a safe cigarette, tobacco or otherwise.

    Do people eat tobacco? (5.00 / 1) (#7)
    by nycstray on Fri Jul 08, 2011 at 11:15:48 PM EST
    There are other ways to use MJ besides smoking it . . .

    And actually, many leaves have health benefits. I'm sure some careful cultivation could be (is) employed to address purity safety etc.


    no doubt there's at least one idiot (none / 0) (#12)
    by cpinva on Sat Jul 09, 2011 at 10:34:53 AM EST
    out there that's tried! :)

    Yes, in Sweden (none / 0) (#37)
    by Nemi on Sun Jul 10, 2011 at 06:32:45 AM EST
    they seem to - kind of. ;)

    re : (none / 0) (#15)
    by ding7777 on Sat Jul 09, 2011 at 01:11:43 PM EST
    Alcohol is not a drug that we pretend has any use in treating disease.

    moderate consumption of alcohol is used for many positive health benefits


    If you wanted it approved as a drug per se (none / 0) (#16)
    by andgarden on Sat Jul 09, 2011 at 01:34:49 PM EST
    You would need to be more specific and do controlled studies. I would expect alcohol to be much more easily approved than anything you have to burn to get a dose.

    Why do we need "approval"? (5.00 / 1) (#18)
    by kdog on Sat Jul 09, 2011 at 02:24:48 PM EST
    Hard to argue with results...results are all that really matters, to the person who is sick at least.

    I never understood why we can't just state the facts, slap it on the label, and let people make up their own mind if a medicine or remedy is right for them and what ails them.

    Its like we got it backwards, telling the sick what works when it is the sick that should be tellin' us.  I've mentioned the brain cancer patient acquaintance of mine, who is the DEA or FDA to tell him it ain't medicine?  Not only cruel and inhumane, but insanely arrogant, as if a propaganda outfit like the DEA has a monopoly on truth.  The proof is in the easing of a patient's suffering, or their healing...and the case is closed after a few millenia of cannabis as medicine...the sh*t works.


    Because we recognize science (none / 0) (#20)
    by andgarden on Sat Jul 09, 2011 at 02:31:06 PM EST
    and that there are professionals who can demonstrate what works and what does not.

    I think you ought to generally be able to use what you want, but if something's going to be approved as a drug, it needs to be studied with rigor.


    It has been studied... (none / 0) (#21)
    by kdog on Sat Jul 09, 2011 at 02:52:53 PM EST
    and when the results don't jive with total prohibition, the study is buried.  I think the science is sound, the "no medicinal use" is the junk science, imo.

    If the quick delivery of smoking is the issue, only "approve" use of vaporizing or eating...concerns alleviated.  Dosage shouldn't be a big concern, considering overdose is impossible. I generally think the best play is to just legalize and regulate and let people do their thing, where I think we agree.  Approval is secondary to getting chains off people for unapproved, if effective, use.  Useful idiots refusing to call it medicine won't bother me if the chains are off and everybody who wants it can get it without risking arrest, medicinally or recreationally.

    A lot of the controversy stems from the fact it is such a popular recreational drug long associated with subversize elements...jazz musicians, hippies, rappers. If nobody used for fun it would be a medicine today, and widely accepted, imo.


    It is total BS. (5.00 / 1) (#23)
    by MileHi Hawkeye on Sat Jul 09, 2011 at 03:58:16 PM EST
    People who have never been really ill or suffer painful chronic conditions don't have any clue what they're talking about.  "Professionals" can't demonstrate shite.  Nobody else can say what kind of pain relief someone else experiences. You can't measure or quantify what someone else feels or the treatment of a nebulous concept like pain-heck, I can't even do it for myself.  That's why this "on a scale of 1 to 10, what would you rate your pain" thing is such a joke.  The only thing that matters that it goes away.

    It's not only pain relief either--I'll give one other example, nausea.  What good is swallowing an anti-nausea pill when you can't keep it down long enough to do any good?  Who wants to be jabbed with a needle and filled full of powerful synthetic drugs that have a long list of other side-effects?  On the other hand, a puff or two and you can actually tolerate food, liquids and/or oral meds.  We've known MJ is an effective anti-nausea treatment for a long, long time.  You don't need a professional to demonstrate that.


    Exactly... (5.00 / 1) (#25)
    by kdog on Sat Jul 09, 2011 at 04:04:08 PM EST
    to hell with criteria, people are suffering while labcoats and those that fund them diddle.

    Your word and the word of any patient is the be all, end all.  On the advice of physicians doesn't hurt either, if it really were not a medicine I don't think we'd see doctors advising their patients of its wonders, legally under state law, or with a wink and a nod in the less enlightened states like NY.


    Laws should be made (5.00 / 1) (#26)
    by MileHi Hawkeye on Sat Jul 09, 2011 at 04:09:35 PM EST
    to serve (wo)mankind, not the other way around.  Unfortunately, that's exactly what some are advocating.  

    And people buy into... (none / 0) (#28)
    by kdog on Sat Jul 09, 2011 at 04:17:56 PM EST
    this subervience to a man-made thing like law or criteria, thats what really baffles.  Intelligent people of sound free minds...conditioning is a helluva drug, whats the classification on that dope?

    Kdog, I have to say (5.00 / 1) (#33)
    by Zorba on Sat Jul 09, 2011 at 08:37:14 PM EST
    that I am in tears while I type this.  My beloved brother died of HIV-AIDS.  He was one of the early ones, in the 1980's.  Nothing gave him relief from the ravages of that terrible disease except.....guess what, marijuana.  Even towards the end, when his appetite waned and he felt absolutely rotten, his partner told me that the only thing that would make my brother feel better, and eat a little something, was marijuana, even when his long-time partner had to blow the marijuana smoke into my brother's lungs because my brother was too weak to light up himself.  Yes, it was illegal.  And, yes, I don't really give a royal sh!t- I would have done the same if he had been living with me at the time.  

    Then change the regulations (none / 0) (#27)
    by andgarden on Sat Jul 09, 2011 at 04:17:00 PM EST
    so that smoked MJ can be approved based on that. Don't just complain about how the FDA supposedly doesn't know anything.

    To reiterate: I'm not saying that buying or using MJ ought to be illegal. It should be. But that doesn't mean that it is therefore approvable as a drug.


    Better people than me... (none / 0) (#29)
    by kdog on Sat Jul 09, 2011 at 04:20:54 PM EST
    put in long hours trying...but its a crooked system...money and power talks, truth walks...even obvious truth like mj helps a lot of sick people.

    Based on the FDA's criteria (none / 0) (#22)
    by andgarden on Sat Jul 09, 2011 at 03:55:42 PM EST
    for the meaning of "no medicinal use," I think they came to the right conclusion.

    Fair enough... (none / 0) (#24)
    by kdog on Sat Jul 09, 2011 at 04:00:23 PM EST
    I think the criteria is flawed, not the plant.

    So explain to me (none / 0) (#35)
    by MileHi Hawkeye on Sat Jul 09, 2011 at 10:51:49 PM EST
    why if MJ (specifically THC) has no medical use as you assert, why has the synthetic form of it (marinol) been approved by the FDA and is used for treatment of nausea and chronic wasting syndrome among other conditions?

    The National freaking Cancer Institute states:

    Cannabis has been used for medicinal purposes for thousands of years.

    Putting aside their ignorance in asserting MJ must for some reason only be smoked, even the DEA recognizes that THC has medical value.


    MJ does not equal Marinol (none / 0) (#36)
    by andgarden on Sun Jul 10, 2011 at 12:51:49 AM EST
    if it did, no one would want "medical" MJ. Right?

    Legalize and regulate it, yes (none / 0) (#32)
    by Peter G on Sat Jul 09, 2011 at 07:42:52 PM EST
    But Andgarden makes good point. Not everything that you might consume to make you feel better when you're sick is "medicine."  Think of herbal tea, and chicken soup.  To say that something hasn't been clinically proven to meet the scientific definition of a therapeutic drug is not by any means to say it should be a crime to grow/make, sell, possess or use it.  Apples and oranges. It may be that THC does have medicinal properties; there seems to be a lot of anecdotal evidence to suggest that is so.  And it's also true that DEA has been making it as hard as possible for competent, independent scientists to prove by real studies whether that's so.  Be that as it may, it apparently hasn't been proven. In terms of public health and safety (and of protection of the sick and elderly from fraud), it's better that we have a FDA that enforces real standards on new drugs than that we don't.

    new drug? (5.00 / 3) (#34)
    by womanwarrior on Sat Jul 09, 2011 at 09:57:47 PM EST
    There is nothing new about marijuana.  And nothing new about tobacco and alcohol.  Really, marijuana should not be treated like it's mdma.  It is wrong scientifically to keep it a schedule 1 drug.  

    In reviewing the original CSA, I learned (none / 0) (#5)
    by oculus on Fri Jul 08, 2011 at 10:55:46 PM EST
    marijuana for personal use was not supported for Schedule I by its drafter, who lost this battle.  And that Congress, has subsequently, on occasion, added substances to the schedules w/o DEA or FDA support.