Posts Tagged Daily Caller

Is the DEA legalizing THC?

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United States Assistant Secretary for Health

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By Mike Riggs – The Daily Caller

In November of last year, the Drug Enforcement Administration (DEA) proposed a seemingly subtle change to its policy on marijuana. Citing recommendations from the assistant secretary for Health at the Department of Health and Human Services, the agency outlined its plan to reschedule pills containing organic dronabinol from schedule I to schedule III.

Dronabinol is short for tetrahydrocannabinol and long for THC. It’s more commonly known as the thing in marijuana that gets you high.

“This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules,” reads the DEA’s proposed rule. “This would have the effect of transferring the FDA-approved versions of such generic Marinol [a synthetic THC drug] products from schedule I to schedule III.”

Paul Armentano of the National Organization for Reform of Marijuana Laws reads the proposal as a way of legalizing marijuana so just Big Pharma can make money from it.

“DEA is taking a shortcut by saying, well, we can reschedule organic THC because it mimics an existing drug on the market,” Armentano said. “Which is ironic given that they are saying the organic substance is derivative of the synthetic substance that is actually based on the organic substance.”

A spokesperson from the DEA told The Daily Caller that the rescheduling of pills containing organic dronabinol is not equivalent to legalizing THC. “Please note that DEA is not ‘rescheduling … organic THC,’” wrote the DEA’s Rusty Payne in an e-mail.

“THC, natural or synthetic, remains a schedule I controlled substance. Under the proposed rule, in those instances in the future where FDA might approve a generic version of Marinol, that version of the drug will be in the same schedule as the brand name version of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant.”

In other words, THC in plant form or as an extract, will still be illegal. What won’t be illegal is if a pharmaceutical company buys THC from a government-licensed provider, puts it in a pill, receives the DEA’s stamp of approval, and sells it a price that will likely be far higher than the price of marijuana.

Armentano said such circular reasoning is a product of decades of hostility towards marijuana research.

“This is the insane rationale necessary for banning medical marijuana,” he said. “Take away the prohibition and the political elements, and you would never have the stretching of logic necessary to pass organic THC but only if it mimics Marinol.”

Payne protested the comparison. “Marinol is not the same thing as marijuana; nor is any generic version of Marinol that might be approved by the FDA in the future. Marijuana (the cannabis plant) contains approximately 500 different chemicals; and dronabinol (the form of THC found in Marinol) is just one of those numerous chemicals in the plant.”

The DEA’s proposed rule says that the agency will only entertain abbreviated new drug applications, the process by which most generics are approved when the patent expires on a branded drug. That means requiring an organic dronabinol drug to mimic Marinol may actually help get an organic pill on the market in record time.

Payne declined to say when the rules would pass. ”There is no timetable for the publication of the final rule. As with all proposed rules, DEA is required by law to give careful consideration to the public comments in deciding whether to finalize the rule.”

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What Do You Know? The Drug Czar Is Lying Again

Medical marijuana usa

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Earlier this week Drug Czar Gil Kerlikowske sat down for a face-to-face interview with The Daily Caller’s Mike Riggs. (Riggs is the Daily Caller reporter who yesterday broke the story regarding the DEA’s plans to reschedule plant-derived THC while keeping the actual plant illegal.)

Riggs asked the Czar some tough questions, including this one specific to medical cannabis: “You’ve said before that you don’t see medical benefits to smoked marijuana and also that the jury is still out on medical marijuana. What sort of scientific consensus does the ONDCP require? How many studies have to come out arguing for medical benefits? What do you need to see?”

The Czar’s reply? “[Y]ou know there are over 100 groups doing marijuana research, and they’re getting their marijuana from the University of Mississippi. There are several things in clinical trials right now. So we’ll just have to wait for those.”

To which I reply ‘Bulls–t!’

As I write today on Alternet.org, a review of the U.S. National Institutes of Health website clinicaltrials.gov shows that there are presently only six FDA-approved trials taking place anywhere in the world involving subjects’ use of actual cannabis. Of these, two are completed, one is assessing the plant’s pharmacokinetics, and one is assessing pot’s alleged harms.

Memo to the Drug Czar: That leaves a grand total of — not “over 100″ — but rather just two ongoing clinical trials to assess the medical efficacy of cannabis. You sir, are a liar (but then again, I suppose we all knew that already).

Pot May Be Instrumental in Combating Cancer, MS and Other Diseases But the Gov’t Refuses to Fund the Necessary Research

via Alternet

[excerpt] A review of the U.S. National Institutes of Health website clinicaltrials.gov shows that NIDA’s kibosh on medical marijuana trials continues unabated. Though a search of ongoing FDA-approved clinical trials using the keyword ‘cannabinoids’ (the active components in marijuana) yields 65 worldwide hits, only six involve subjects’ use of actual cannabis. (The others involve the use of synthetic cannabinoid agonists like dronabinol or nabilone, the commercially marketed marijuana extract Sativex, or the cannabinoid receptor blocking agent Rimonabant.)

Of the six, two of the studies are already completed: ‘Opioid and Cannabinoid Pharmacokinetic Interactions‘ and ‘Vaporization as a Smokeless Cannabis Delivery System,’ both of which were spearheaded by researchers (primarily Dr. Donald Abrams) at the University of California at San Francisco.

The four remaining studies are still in the ‘recruitment’ phase. Of these, only two pertain to the potential medical use of cannabis: ‘Cannabis for Spasticity of Multiple Sclerosis,’ which is taking place at the University of California at Davis and is likely the final clinical trial associated with the soon-to-be-defunct/defunded California Center for Medicinal Cannabis Research, and ‘Cannabis for Inflammatory Bowel Disease,’ led by researchers at the Meir Medical Center in Israel.

Of the remaining studies, one focuses on the detection of cannabinoids and their metabolites on drug screens, while the other, entitled ‘Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks,’ seeks to establish pot-related harms — hypothesizing that subjects “demonstrate poorer decision-making abilities and increased risk-taking behaviors” after smoking marijuana.

You can read the full interview with Drug Czar Kerlikowske here.

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