However, there are several hurdles to overcome.

Price will probably be one.

In preliminary trials, involving 165 people in the early stages of the disease, the Swiss-designed drug triggered the removal of amyloid from the brain.

So does THC, by the by.

In preliminary trials, involving 165 people in the early stages of the disease, the Swiss-designed drug triggered the removal of amyloid from the brain.

So does THC, by the by.

DEA, Docket DEA-427, Denial to Petition To Initiate Proceedings To Reschedle Marijuana, Fed. Reg. Vol. 81, No. 156 (12 August 2016) page 53776

Cardiovascular and Autonomic Effects

Single smoked or oral doses of delta⁹-THC produce tachycardia and may increase blood pressure (Capriotti et al., 1988; Benowitz and Jones, 1975). Some evidence associates the tachycardia produced by delta⁹-THC with excitation of the sympathetic and depression of the parasympathetic nervous systems (Malinowska et al., 2012). During chronic marijuana ingestion, a tolerance to tachycardia develops (Malinowska et al., 2012).

However, prolonged delta⁹-THC ingestion produces bradycardia and hypotension (Benowitz and Jones, 1975). Plant-derived cannabinoids and endocannabinoids elicit hypotension and bradycardia via activation of peripherally-located CB1 receptors (Wagner et al., 1998). Specifically, the mechanism of this effect is through presynaptic CB1 receptor-mediated inhibition of norepinephrine release from peripheral sympathetic nerve terminals, with possible additional direct vasodilation via activation of vascular cannabinoid receptors (Pacher et al., 2006). In humans, tolerance can develop to orthostatic hypotension (Jones, 2002; Sidney, 2002) possibly related to plasma volume expansion, but tolerance does not develop to the supine hypotensive effects (Benowitz and Jones, 1975). Additionally, electrocardiographic changes are minimal, even after large cumulative doses of delta⁹-THC are administered. (Benowitz and Jones, 1975).

Marijuana smoking by individuals, particularly those with some degree of coronary artery or cerebrovascular disease, poses risks such as increased cardiac work, catecholamines and carboxyhemoglobin, myocardial infarction, and postural hypotension (Benowitz and Jones, 1981; Hollister, 1988; Mittleman et al., 2001; Malinowska et al., 2012).

Cardiovascular and Autonomic Effects

Single smoked or oral doses of delta9-THC produce tachycardia and may increase blood pressure (Capriotti et al., 1988; Benowitz and Jones, 1975). Some evidence associates the tachycardia produced by delta9-THC with excitation of the sympathetic and depression of the parasympathetic nervous systems (Malinowska et al., 2012). During chronic marijuana ingestion, a tolerance to tachycardia develops (Malinowska et al., 2012).

However, prolonged delta9-THC ingestion produces bradycardia and hypotension (Benowitz and Jones, 1975). Plant-derived cannabinoids and endocannabinoids elicit hypotension and bradycardia via activation of peripherally-located CB1 receptors (Wagner et al., 1998). Specifically, the mechanism of this effect is through presynaptic CB1 receptor-mediated inhibition of norepinephrine release from peripheral sympathetic nerve terminals, with possible additional direct vasodilation via activation of vascular cannabinoid receptors (Pacher et al., 2006). In humans, tolerance can develop to orthostatic hypotension (Jones, 2002; Sidney, 2002) possibly related to plasma volume expansion, but tolerance does not develop to the supine hypotensive effects (Benowitz and Jones, 1975). Additionally, electrocardiographic changes are minimal, even after large cumulative doses of delta9-THC are administered. (Benowitz and Jones, 1975).

Marijuana smoking by individuals, particularly those with some degree of coronary artery or cerebrovascular disease, poses risks such as increased cardiac work, catecholamines and carboxyhemoglobin, myocardial infarction, and postural hypotension (Benowitz and Jones, 1981; Hollister, 1988; Mittleman et al., 2001; Malinowska et al., 2012).

Well, if the gubmint sez it, it must be so.

Because bureaucrats are never wrong.

Well, if the gubmint sez it, it must be so.

Because bureaucrats are never wrong.

Actually, is is extensively footnoted to scientific studies.

So THC has negative side effects - does aducanumab have none? Ought we ban all medicines with negative side effects?

One of those side effects being myocardial infarction.

Aducanumab is in the clinical trial stage.

Test marijuana, submit your results, and get approved.

For marijuana, note that "[c]urrently, no published studies conducted with marijuana meet the criteria of an adequate and well-congroled efficacy study." FR 53780.

Fed. Reg. 53780, August 12, 2016

The PubMed search yielded a total of 566 abstracts of scientific articles. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. Of the studies identified through the search of the references and the 566 abstracts from the PubMed search, only 11 studies met all the criteria for selection (Abrams et al., 2007; Corey-Bloom et al., 2012; Crawford and Merritt, 1979; Ellis et al., 2009; Haney et al., 2005; Haney et al., 2007; Merritt et al., 1980; Tashkin et al., 1974; Ware et al., 2010; Wilsey et al., 2008; Wilsey et al., 2013). These 11 studies were published between 1974 and 2013. Ten of these studies were conducted in the United States and one study was conducted in Canada. The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma. All studies used adult subjects.

The 11 identified studies were individually evaluated to determine if they successfully meet accepted scientific standards. Specifically, they were evaluated on study design including subject selection criteria, sample size, blinding techniques, dosing paradigms, outcome measures, and the statistical analysis of the results. The analysis relied on published studies, thus information available about protocols, procedures, and results were limited to documents published and widely available in the public domain. The review found that all 11 studies that examined effects of inhaled marijuana do not currently prove efficacy of marijuana in any therapeutic indication based on a number of limitations in their study design; however, they may be considered proof of concept studies. Proof of concept studies provide preliminary evidence on a proposed hypothesis involving a drug’s effect. For drugs under development, the effect often relates to a short-term clinical outcome being investigated. Proof of concept studies often serve as the link between preclinical studies and dose ranging clinical studies. Thus, proof of concept studies generally are not sufficient to prove efficacy of a drug because they provide only preliminary information about the effects of a drug.

Test marijuana, submit your results, and get approved.

I say, leave medical decisions to doctors in consultation with patients.

I say, leave medical decisions to doctors in consultation with patients.

I say, that's not what the law says. If you dislike the law, work to change the law.

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

If you dislike the law, work to change the law.

Will I have your support?

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

Doctors have misprescribed opiate painkillers - shall we ban those too?

Doctors have misprescribed opiate painkillers - shall we ban those too?

It'll be interesting to see how nolu sham answers that...

If you dislike the law, work to change the law.

Will I have your support?

I will support your efforts to meet the legal requirements. The only lawful possession is for federally authorized research. Other than that, marijuana (including so-called medical marijuana) is illegal in any quantity in all 52 federal jurisdictions, which includes all 50 states.

If you can get the federal law changed, I will acknowledge your achievement if I live that long. Citizen proposals that become state laws have no legal effect if they conflict with federal law.

A big opponent may be the alcohol lobby and the tax man. Think of what legal pot would do to alcohol sales and taxes.

If you can change the law, and make marijuana legal like alcohol, be prepared for what happened to alcohol when prohibition ended. No one will be allowed to grow and sell to individuals or retailers. All sales will go to licensed distributors. That was how government weeded (extra credit for word play) out mobsters from legitimate businesses. A very significant federal marijuana tax will be reinstated. The tax only stopped when marijuana was declared illegal. There is no taxing of a substance that is illegal to possess.

The relatively small pot farms will be inundated with regulations, making pot cultivation expensive. They will need paper shufflers and accountants. The costs of doing business will force them to succumb to big farming. Give it time and you will have Monsanto pot. Plan on government taxing at a rate to maintain revenue.

I do not personally care if you smoke so much pot that Willie Nelson gets high off your secondary smoke. That would not extend to driving stoned on a public road, or running about with gun while seriously impaired.

As for getting approval of marijuana for medical use, the first major hurdle to get over is:

i. the drug’s chemistry must be known and reproducible

"The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement."

See Fed. Reg. 81-156, 12 Aug 2016 at 53779.

As for doctors, they have already proven that they will prescribe marijuana for patients they have either not fully evaluated, or whom they have not met at all.

Doctors have misprescribed opiate painkillers - shall we ban those too?

We should take the licenses of those doctors and put them in prison. They have committed crimes and created drug addicts.

Usually, they at least see the patient. Pot scrips have been written for patients never seen, much less evaluated. The substance is illegal, the scrip is illegal, the doctor is committing a criminal act, and the patient may wind up prosecuted for unlawful possession.

Many doctors have misprescribed antibiotics for the common cold. About all they accomplish is to facilitate growing superbugs. It should be stopped, but it is not an argument for or against marijuana.

"Will I have your support?"

If you can get the federal law changed, I will acknowledge your achievement if I live that long.

Not what I asked. Will you answer the question I asked?

"Doctors have misprescribed opiate painkillers - shall we ban those too?"

We should take the licenses of those doctors and put them in prison. They have committed crimes and created drug addicts.

Again, not what I asked. Will you answer the question I asked?

it is not an argument for or against marijuana.

I never said nor implied it was; but if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug.

how nolu sham answers that

He didn't ... while trying to look like he did.

Will I have your support?

I will support your efforts to meet the legal requirements.

That's was your answer. If you want to select something from another paragraph down, that is your choice.

if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug.

Medicines are legal, marijuana is not. Misprescribing legal opiate painkillers does nothing to make marijuana legal. Your bullshit is just bullshit.

If you dislike the law, work to change the law.

"Will I have your support?"

I will support your efforts to meet the legal requirements.

Still not what I asked.

"if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug."

Medicines are legal

According to your argument, since they're misprescribed they shouldn't be.

Misprescribing legal opiate painkillers does nothing to make marijuana legal.

I never said nor implied it did. Your bullshit is just bullshit.

"Doctors have misprescribed opiate painkillers - shall we ban those too?" ---- if misprescribing antibiotics or opiate painkillers is not an argument for banning those drugs, then misprescribing marijuana is not an argument for banning that drug. -- C.F.

nolu sham --- Medicines are legal, marijuana is not. Misprescribing legal opiate painkillers does nothing to make marijuana legal.

Incredibly silly circular reasoning.

--- This clown pretends to be a legal expert, posting page after page of court opinions, yet he reasons like a grade school dropout. -- Pitiful display.

So does THC, by the by.

It cannot be privatized. Look up rent seeking.

"So does THC, by the by."

It cannot be privatized. Look up rent seeking.

Oh, I know very well why rent-seeking Big Pharma is against medical marijuana.

This clown pretends to be a legal expert, posting page after page of court opinions, yet he reasons like a grade school dropout.

That's nolu spam/sham in a nutshell. Though maybe not so much "dropout" as "dropped on his head."

Your pretended concern about medical marijuana is as believeable as the stories being spun by your heroine, Hillary.

As for getting approval of marijuana for medical use, the first major hurdle to get over is:

i. the drug’s chemistry must be known and reproducible

"The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement."

See Fed. Reg. 81-156, 12 Aug 2016 at 53779.

I see how fast you have run from that. Of course, another hurdle will be the delivery system.

We do not ban drugs that have met all the requirements to be legally prescribed because a doctor misbehaves.

We do not authorize the dispensing of illegal drugs that have not met the requirements to be legally prescribed because you want to get high.

When you make an effort to create medical marijuana, you may be taken seriously. In the meantime, you might as well drop the bullshit and admit you are using the term medical marijuana just to further your cause of recreational marijuana. You want a legal high. Good luck with that.

We do not ban drugs that have met all the requirements to be legally prescribed because a doctor misbehaves.

So the business about how some doctors misprescribe marijuana was a red herring on your part.

So the business about how some doctors misprescribe marijuana was a red herring on your part.

No. It was pointing out that your crying about medicine for sick people is a crock of shit and always has been. All of a sudden, everybody has a debilitating condition that calls for marijuana which you apparently believe has been proven to cure all maladies known to man.

There is no such thing as misprescribing marijuana. It is illegal to possess, in any qualtity, pursuant to federal law. It is a crime in all 52 federal jurisdictions, which includes all 50 states.

It is your incessant bullshit about medical and medicine that is the red herring. Marijuana has never met the standards for a prescription drug product. Marijuana is not medicine.

You will do just about anything to change the subject from the requirements for medicine approval.

You can always try addressing the first element required by established case law. Or not. You can always just continue to act on your supreme belief that you can baffle people with your bullshit.

In general, a drug may have a ‘‘currently accepted medical use’’ in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA’s application of the five-part test to determine whether a drug has a ‘‘currently accepted medical use.’’ The following describes the five elements that characterize ‘‘currently accepted medical use’’ for a drug:

i. the drug’s chemistry must be known and reproducible

‘‘The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.’’

81 FR 53779.

All of a sudden, everybody has a debilitating condition that calls for marijuana which you apparently believe has been proven to cure all maladies known to man.

Beat those straw men.

Beat those straw men.

You will do just about anything to change the subject from the requirements for medicine approval. Marijuana is illegal. It is not medicine.

You can always try addressing the first element required by established case law. Or not. You can always just continue to act on your supreme belief that you can baffle people with your bullshit.

In general, a drug may have a ‘‘currently accepted medical use’’ in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA’s application of the five-part test to determine whether a drug has a ‘‘currently accepted medical use.’’ The following describes the five elements that characterize ‘‘currently accepted medical use’’ for a drug:

i. the drug’s chemistry must be known and reproducible

‘‘The substance’s chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.’’

81 FR 53779.

That's one of five, and marijuana fails all five.

You will do just about anything to change the subject

Quoting your words is not changing the subject, fool.

DEA, 81 FR 53779-53781, August 12, 2016

Status of Research Into the Medical Uses for Marijuana

State-level public initiatives, including laws and referenda in support of the medical use of marijuana, have generated interest in the medical community and the need for high quality clinical investigation as well as comprehensive safety and effectiveness data. In order to address the need for high quality clinical investigations, the state of California established the Center for Medicinal Cannabis Research (CMCR, www.cmcr.ucsd.edu) in 2000 ''in response to scientific evidence for therapeutic possibilities of cannabis[9] and local legislative initiatives in favor of compassionate use'' (Grant, 2005). State legislation establishing the CMCR called for high quality medical research that would ''enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent,'' but stressed the project ''should not be construed as encouraging or sanctioning the social or recreational use of marijuana.'' The CMCR funded many of the published studies on marijuana's potential use for treating multiple sclerosis, neuropathic pain, appetite suppression and cachexia. However, aside from the data produced by CMCR, no state-level medical marijuana laws have produced scientific data on marijuana's safety and effectiveness.

FDA approves medical use of a drug following a submission and review of an NDA or BLA. The FDA has not approved any drug product containing marijuana for marketing. Even so, results of small clinical exploratory studies have been published in the current medical literature. Many studies describe human research with marijuana in the United States under FDA-regulated IND applications.

However, FDA approval of an NDA is not the only means through which a drug can have a currently accepted medical use in treatment in the United States. In general, a drug may have a ''currently accepted medical use'' in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA's application of the five-part test to determine whether a drug has a ''currently accepted medical use.'' The following describes the five elements that characterize ''currently accepted medical use'' for a drug[10]:

i. the drug's chemistry must be known and reproducible

''The substance's chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.''

ii. there must be adequate safety studies

''There must be adequate pharmacological and toxicological studies, done by all methods reasonably applicable, on the basis of which it could fairly and responsibly be concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder.''

iii. there must be adequate and well- controlled studies proving efficacy

''There must be adequate, well- controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, on the basis of which it could be fairly and responsibly concluded by such experts that the substance will have the intended effect in treating a specific, recognized disorder.''

iv. the drug must be accepted by qualified experts

''The drug has a New Drug Application (NDA) approved by the Food and Drug Administration, pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 355. Or, a consensus of the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus.'' and

v. the scientific evidence must be widely available

''In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available, in sufficient detail to permit experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder.''

Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.''

Firstly, the chemistry of marijuana, as defined in the petition, is not reproducible in terms of creating a standardized dose. The petition defines marijuana as including all Cannabis cultivated strains. Different marijuana samples derived from various cultivated strains may have very different chemical constituents including delta9-THC and other cannabinoids (Appendino et al., 2011). As a consequence, marijuana products from different strains will have different safety, biological, pharmacological, and toxicological profiles. Thus, when considering all Cannabis strains together, because of the varying chemical constituents, reproducing consistent standardized doses is not possible. Additionally, smoking marijuana currently has not been shown to allow delivery of consistent and reproducible doses. However, if a specific Cannabis strain is grown and processed under strictly controlled conditions, the plant chemistry may be kept consistent enough to produce reproducible and standardized doses.

As to the second and third criteria; there are neither adequate safety studies nor adequate and well-controlled studies proving marijuana's efficacy. To support the petitioners' assertion that marijuana has accepted medical use, the petitioners cite the American Medical Association's (AMA) 2009 report entitled ''Use of Cannabis for Medicinal Purposes.'' The petitioners claim the AMA report is evidence the AMA accepts marijuana's safety and efficacy. However, the 2009 AMA report clarifies that the report ''should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the same and current standards for a prescription drug product.[11]''

Currently, no published studies conducted with marijuana meet the criteria of an adequate and well-controlled efficacy study. The criteria for an adequate and well-controlled study for purposes of determining the safety and efficacy of a human drug are defined under the Code of Federal Regulations (CFR) in 21 CFR 314.126. In order to assess this element, FDA conducted a review of clinical studies published and available in the public domain before February, 2013. Studies were identified through a search of PubMed[12] for articles published from inception to February 2013, for randomized controlled trials using marijuana to assess marijuana's efficacy in any therapeutic indication. Additionally, the review included studies identified through a search of bibliographic references in relevant systematic reviews and identified studies presenting original research in any language. Selected studies needed to be placebo-controlled and double-blinded. Additionally, studies needed to encompass administered marijuana plant material. There was no requirement for any specific route of administration, nor any age limits on study subjects. Studies were excluded that used placebo marijuana supplemented by the addition of specific amounts of THC or other cannabinoids. Additionally, studies administering marijuana plant extracts were excluded.

The PubMed search yielded a total of 566 abstracts of scientific articles. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. Of the studies identified through the search of the references and the 566 abstracts from the PubMed search, only 11 studies met all the criteria for selection (Abrams et al., 2007; Corey-Bloom et al., 2012; Crawford and Merritt, 1979; Ellis et al., 2009; Haney et al., 2005; Haney et al., 2007; Merritt et al., 1980; Tashkin et al., 1974; Ware et al., 2010; Wilsey et al., 2008; Wilsey et al., 2013). These 11 studies were published between 1974 and 2013. Ten of these studies were conducted in the United States and one study was conducted in Canada. The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma. All studies used adult subjects.

The 11 identified studies were individually evaluated to determine if they successfully meet accepted scientific standards. Specifically, they were evaluated on study design including subject selection criteria, sample size, blinding techniques, dosing paradigms, outcome measures, and the statistical analysis of the results. The analysis relied on published studies, thus information available about protocols, procedures, and results were limited to documents published and widely available in the public domain. The review found that all 11 studies that examined effects of inhaled marijuana do not currently prove efficacy of marijuana in any therapeutic indication based on a number of limitations in their study design; however, they may be considered proof of concept studies. Proof of concept studies provide preliminary evidence on a proposed hypothesis involving a drug's effect. For drugs under development, the effect often relates to a short-term clinical outcome being investigated. Proof of concept studies often serve as the link between preclinical studies and dose ranging clinical studies. Thus, proof of concept studies generally are not sufficient to prove efficacy of a drug because they provide only preliminary information about the effects of a drug.

In addition to the lack of published adequate and well-controlled efficacy studies proving efficacy, the criteria for adequate safety studies has also not been met. Importantly, in its discussion of the five-part test used to determine whether a drug has a ''currently accepted medical use,'' DEA said, ''No drug can be considered safe in the abstract. Safety has meaning only when judged against the intended use of the drug, its known effectiveness, its known and potential risks, the severity of the illness to be treated, and the availability of alternative remedies'' (57 FR 10504). When determining whether a drug product is safe and effective for any indication, FDA performs an extensive risk-benefit analysis to determine whether the risks posed by the drug product's side effects are outweighed by the drug product's potential benefits for a particular indication. Thus, contrary to the petitioner's assertion that marijuana has accepted safety, in the absence of an accepted therapeutic indication which can be weighed against marijuana's risks, marijuana does not satisfy the element for having adequate safety studies such that experts may conclude that it is safe for treating a specific, recognized disorder.

The fourth of the five elements for determining ''currently accepted medical use'' requires that the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus. Medical practitioners who are not experts in evaluating drugs are not qualified to determine whether a drug is generally recognized as safe and effective or meets NDA requirements (57 FR 10499-10505).

There is no evidence that there is a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder. As discussed above, there are not adequate scientific studies that show marijuana is safe and effective in treating a specific, recognized disorder. In addition, there is no evidence that a consensus of qualified experts have accepted the safety and effectiveness of marijuana for use in treating a specific, recognized disorder. Although medical practitioners are not qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, we also note that the AMA's report, entitled ''Use of Cannabis for Medicinal Purposes,'' does not accept that marijuana currently has accepted medical use. Furthermore, based on the above definition of a ''qualified expert'', who is an individual qualified by scientific training and experience to evaluate the safety and effectiveness of a drug, state-level medical marijuana laws do not provide evidence of a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder.

As to the fifth part of the test, which requires that information concerning the chemistry, pharmacology, toxicology, and effectiveness of marijuana to be reported in sufficient detail, the scientific evidence regarding all of these aspects is not available in sufficient detail to allow adequate scientific scrutiny. Specifically, the scientific evidence regarding marijuana's chemistry in terms of a specific Cannabis strain that could produce standardized and reproducible doses is not currently available.

Alternately, a drug can be considered to have a ''currently accepted medical use with severe restrictions'' (21 U.S.C. 812(b)(2)(B)), as allowed under the stipulations for a Schedule II drug. Yet, as stated above, currently marijuana does not have any accepted medical use, even under conditions where its use is severely restricted.

In conclusion, to date, research on marijuana's medical use has not progressed to the point where marijuana is considered to have a ''currently accepted medical use'' or a ''currently accepted medical use with severe restrictions.''

- - - - - - - - - -

[9] In this quotation the term cannabis is interchangeable with marijuana.

[10] 57 FR I 0499, 10504–06 (March 26, 1992).

[11] In this quotation the term cannabis is used interchangeably for marijuana.

[12] The following search strategy was used, ‘‘(cannabis OR marijuana) AND (therapeutic use OR therapy) AND (RCT OR randomized controlled trial OR ‘‘systematic review’’ OR clinical trial OR clinical trials) NOT (‘‘marijuana abuse’’[Mesh] OR addictive behavior OR substance related disorders).’’