DEA Issues ‘Final Order’ Rejecting Private Production Of Cannabis For FDA-Approved Research

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The United States Drug Enforcement Administration (DEA) has issued its final order rejecting a ruling from the agency’s own Administrative Law Judge finding that it would be ‘in the public interest’ to grant the University of Massachusetts a license to grow marijuana for federally regulated research.

The rejection preserves the monopoly held by National Institute on Drug Abuse (NIDA) on the supply of marijuana for Food and Drug Administration (FDA)-regulated research. In 2010, a spokesperson for the agency told the New York Times, “We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

In 2007, after extensive hearings, DEA Judge Mary Ellen Bittner opined in favor of allowing a researcher at the University of Massachusetts at Amherst legal permission to cultivate marijuana for use in FDA-approved clinical trials.

She determined: “I conclude that granting Respondent’s application would not be inconsistent with the Single Convention, that there would be minimal risk of diversion of marijuana resulting from Respondent’s registration, that there is currently an inadequate supply of marijuana available for research purposes, that competition in the provision of marijuana for such purposes is inadequate, and that Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances. I therefore find that Respondent’s registration to cultivate marijuana would be in the public interest.”

DEA director Michele Leonhart initially set aside Judge Bittner’s ruling in 2009.

The agency’s ruling may be appealed in the First Circuit US Court of Appeals.

In July, the DEA denied a nine-year-old petition seeking to initiate hearings regarding the federal classification of cannabis as a schedule I controlled substance, stating in part, “[T]here are no adequate and well-controlled studies proving efficacy.”

Israeli Government Officially Recognizes The Therapeutic Value Of Cannabis — Pot Production And Distribution To Begin January 2012

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The Israeli government this week formally acknowledged the therapeutic utility of cannabis and announced newly amended guidelines governing the state-sponsored production and distribution of medical cannabis to Israeli patients.

A prepared statement posted Monday on the website of office of the Israeli Prime Minister states: “The Cabinet today approved arrangements and supervision regarding the supply of cannabis for medical and research uses. This is in recognition that the medical use of cannabis is necessary in certain cases. The Health Ministry will – in coordination with the Israel Police and the Israel Anti-Drug Authority – oversee the foregoing and will also be responsible for supplies from imports and local cultivation.”

According to Israeli news reports, approximately 6,000 Israeli patients are supplied with locally grown cannabis as part of a limited government program. This week’s announcement indicates that government officials intend to expand the program to more patients and centralize the drug’s cultivation. “[T]here are predictions that doctor and patient satisfaction is so high that the number could reach 40,000 in 2016,” The Jerusalem Post reported.

The Israeli Ministry of Health is expected to oversee the production of marijuana in January 2012.

Similar government-sponsored medical marijuana programs are also active in Canada and the Netherlands.

By contrast, in July the United States Drug Enforcement Administration (DEA) formally denied a nine-year-old petition calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance, stating in the July 8, 2011 edition of the Federal Register that cannabis has “a high potential for abuse; … no currently accepted medical use in treatment in the United States; … [and] lacks accepted safety for use under medical supervision.”

Latest White House Drug Strategy Report Affirms Our Government Has Virtually No Interest In Actually Studying Marijuana

The White House yesterday, with little fanfare, issued its annual (and long overdue) 2011 National Drug Control Strategy report.

As usual, the White House’s official justification for the ongoing multigenerational drug war was light on facts and heavy on rhetoric, particularly as it pertained to the federal government’s fixation with criminalizing cannabis. Here are just a few examples (all of which are excerpted from a section of the report, entitled ironically enough, ‘The Facts About Marijuana‘) of your government on pot.

“[C]onfusing messages being conveyed by the entertainment industry, media, proponents of ‘medical’ marijuana, and political campaigns to legalize all marijuana use perpetuate the false notion that marijuana use is harmless and aim to establish commercial access to the drug. This significantly diminishes efforts to keep our young people drug free and hampers the struggle of those recovering from addiction.”

“Marijuana and other illicit drugs are addictive and unsafe. … The science, though still evolving in terms of long-term consequences, is clear: marijuana use is harmful. Independent from the so called ‘gateway effect’ — marijuana on its own is associated with addiction, respiratory and mental illness, poor motor performance, and cognitive impairment, among other negative effects.”

“The Administration steadfastly opposes drug legalization. Legalization runs counter to a public health approach to drug control because it would increase the availability of drugs, reduce their price, undermine prevention activities, hinder recovery support efforts, and pose a significant health and safety risk to all Americans, especially our youth.”

You get the idea.

Of course, none of these allegations represent anything new for this (or previous) administrations, and NORML has responded in detail to most of the Drug Czar’s claims previously. I did, however, take notice of this particular paragraph in the report, which appears under the title ‘Medical’ Marijuana.’

“In the United States, the Drug Enforcement Administration (DEA) has approved 109 researchers to perform bona fide research with marijuana, marijuana extracts, and marijuana derivatives such as cannabidiol and cannabinol. Studies include evaluation of abuse potential, physical/psychological effects, adverse effects, therapeutic potential, and detection. Fourteen researchers are approved to conduct research with smoked marijuana on human subjects.”

Only in an environment of absolute criminal prohibition can the administration imply, with a straight face, that allowing a grand total of 14 legally permitted scientists to study a substance consumed by tens of millions of Americans for therapeutic and/or recreational purposes is somehow to be construed as ‘progress.’ That total doesn’t even legally allow for one scientist per medical marijuana state to actively assess how cannabis is impacting that state’s patient population.

Moreover, this acknowledgment comes from the very same administration that on Friday flat out rejected the notion of even allowing hearings on the question of marijuana’s schedule I classification because, in their opinion, “there are no adequate and well-controlled studies proving efficacy.” Of course, with only a dozen or so scientists in the whole county even permitted to interact with pot and humans can there be any wonder why such studies aren’t more prevalent?

(By the way, remember the results last year of the series of FDA-approved ‘gold standard’ clinical trials assessing the safety and efficacy of inhaled cannabis in severely ill patients? Apparently neither does the DEA. Nor are they aware of these ‘well-controlled’ studies of medical cannabis. Or these.)

Interestingly, according to the DEA’s 2010 white paper on cannabis (no longer online), last year there were a total of 18 scientists licensed by the government to work with marijuana in a clinical setting. Perhaps next year there will only be ten. If the DEA and NIDA have there way perhaps by 2013 there will be zero.

As for the other 95 US scientists legally authorized by the federal government to assess the efficacy of ‘marijuana extracts and marijuana derivatives’ in animals, most of them were here last week — at the annual meeting of the International Cannabinoid Research Society. But even these ‘chosen few’ acknowledge that their work has next to no influence on the very administration that authorizes it.

Marijuana Researchers Meet At Pheasant Run
Researchers from around the world studying the effects of marijuana and exploring possible medical uses meet each year to compare notes and share their findings

About 250 scientists from around the world have gathered this weekend at Pheasant Run Resort sitting through seminars titled “Endocannabinoid Signaling in Periimplantation Biology,” and “Cannabinoids and HIV Pathogenicity,” to name a few, for the 21st Annual Symposium of the International Cannabinoid Research Society.

ICRS members meet once a year to compare notes on research studying how cannabinoids, compounds from the cannabis plant (more commonly known as marijuana) or from the brain called endocannabinoids, affect the body and how it functions.

While most attendees are scientists, many are graduate students or training scientists as well as physicians interested in learning how these chemicals might be useful in treating human disease.

“We are all around the world working on our own projects,” said Cecilia Hillard, ICRS executive director, professor of pharmacology and director of the Neuroscience Research Center at the Medical College of Wisconsin.

“That’s why it’s so wonderful for us to get together once a year so we can really share things that we learn,” she said.

For example, she said someone may be studying how bone is formed, and she is studying how the brain works.

“I learn a lot by learning how the bone is formed, and they learn about how neurons work,” Hillard said. “It’s really a lot of what we call a ‘cross-fertilization’ of ideas.”

While the society is not political, Hillard says the type of research that is done on the controversial topic of medical and personal use of marijuana is nonetheless important.

“We’re carrying out scientific investigations trying to understand what these molecules do,” Hillard said. “What we try to contribute to the debate is the reality.”

She said scientific investigation is done in a very neutral way, trying to understand what these molecules do.

“The mass appeal is, ‘is there a good use for this in the treatment of human disease?’” Hillard said. “Most of us really have a passion for looking at these molecules because there is a lot of potential for treatment of human disease.”

The findings of this research are published in scientific journals so that the information is available to anyone. She said sometimes “you have no idea the impact your work is having.” Hillard said part of the mission of the ICRS is to educate the public.

“I wish the politicians would (look at the data) but I don’t think they do,” she said.

Federal Government Reaffirms ‘Flat Earth’ Position Regarding Medical Cannabis

Earlier today, United States DEA Administrator Michele Leonhart reaffirmed in the Federal Register the administration’s ‘flat Earth’ position regarding the medical properties of cannabis.

Responding to a nine-year-old petition to reclassify marijuana under federal law filed by a coalition of advocacy groups, including NORML and California NORML, Leonhart stated, “[T]here is no substantial evidence that marijuana should be removed from schedule I.”

A summary of Ms. Leonhart’s ‘reasoning’ is below. (Read the DEA’s full response here.)

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Chapter II [Docket No. DEA–352N]

Denial of Petition To Initiate Proceedings
To Reschedule Marijuana

AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION:

Denial of petition to initiate proceedings to reschedule marijuana.

(1) Marijuana has a high potential for abuse. The DHHS 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. According to established case law, marijuana has no ‘‘currently accepted medical use’’ because: 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. 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.

Coalition advocates will be appealing Leonhart’s decision in federal court.

NORML had previously filed a similar rescheduling petition with the DEA in 1972, but was not granted a federal hearing on the issue until 1986. In 1988, DEA Administrative Law Judge Francis Young ruled that marijuana did not meet the legal criteria of a Schedule I prohibited drug and should be reclassified. Then-DEA Administrator John Lawn rejected Young’s determination, a decision the D.C. Court of Appeals eventually affirmed in 1994.

A subsequent petition was filed by former NORML Director Jon Gettman in 1995, but was rejected by the DEA in 2001.

NORML will have additional information on this story in next week’s NORML media advisory.

Whack and Stack: 2010 Marijuana Cultivation Eradication In America

[Editor's note: Call it a terrible waste of police time, an unnecessary risk to law enforcement personnels' lives, a loud and destructive invasion of one's curtilage, the proverbial taxpayer-funded pursuit of a needle in a haystack, an unintended government-provided price support for an illegal and untaxed commercial market, or a bizarre police ruse where a valuable agricultural product---industrial hemp; which is even subsidized by the European Union to cultivate as an industrial fiber crop---is paraded out in front of unknowing (or not...) media who dutifully snap photos, capture video and write about any one law enforcement project involved in regional domestic cannabis eradication as being 'successful'.

Call it what ever you choose, but it is that time of year again to see where and in what quantities the DEA claims it whacks and stacks outdoor and indoor cannabis eradicated within America's borders, even though, as noted below, the DEA stopped honestly reporting the ratio of World War II-era feral hemp eradicated to actual cultivated cannabis plants (for recreational or medical uses) in 2006.]

by Matthew Donigian, NORML legal intern, University of Illinois — College of Law

In the most recent DEA Domestic Cannabis Eradication/Suppression Program Statistical Report, the DEA indicated that over 10 million marijuana plants throughout the United States were destroyed by the agency. According to this report, most of the eradicated plants were found in California, followed by West Virginia, Tennessee, Kentucky, and Washington State. The states with the least eradicated plants were Rhode Island, North Dakota, South Dakota, Wyoming, and Delaware.

The report also detailed the number of eradicated plants that were being cultivated indoors. The states with the highest number of eradicated indoor plants were California, Florida, Washington, Michigan, and Ohio. California is the obvious leader here, since its highly successful medical marijuana market has been the primary target of DEA operations. However, proponents of merciless penalties for cultivation of marijuana in Florida may be surprised to see the state in the number two spot, ahead of both Michigan and Washington State, two of the largest medical marijuana jurisdictions.  It seems that the policy touted by supporters as the silver bullet to large-scale marijuana production in the state has failed.

This should not come as a surprise to those familiar with the rhetoric supporting the failed War on Drugs. For the past 40 years, the federal government has promised decreased crime, overdose deaths, and addiction rates as a result of the punitive and prohibitive approach of the war and drugs, but has failed to deliver these results. In 2009, Florida drastically increased its penalties for cultivation of marijuana, which punish the cultivation of 25 or more marijuana plants with up to 15 years of imprisonment. Much like federal marijuana prohibition, increasing penalties in Florida in order to decrease cultivation has been an abject failure. In the most recent DEA eradication report, Florida ranked second in eradicated indoor marijuana plants, with 51,366 plants eradicated in 2010, only 1265 fewer plants than were eradicated per year from 1998-2008 (on average).  In addition there were nearly 500 more arrests associated with marijuana eradication in 2010 than there were on average between the years of 1998-2008.

In addition, since 2006, the report excludes statistics on the number of “ditchweed” or non-cultivated feral marijuana plants, eradicated each year. According to the DEA, eradication of ditchweed is still taking place but the agency refrains from reporting the number of eradicated plants, making it difficult to estimate the resources spent on this practice. The federal government seems to have misinterpreted criticism that the practice was a waste of resources; critics were not upset with the governments reporting of “ditchweed”, but rather the practice of seeking out and burning non-smokeable and non-cultivated cannabis plants. The last published eradication data for “ditchweed” indicated that over 200 million or 98 percent of all plants eradicated were feral marijuana. The current practice of non-reporting provides the American people with little information on where DEA resources are being utilized, and effectively hides the amount of money spent on an unintelligible practice.  

Increasing penalties against marijuana crimes and eradicating marijuana plants does nothing to prevent the use of marijuana. Since the war on drugs began the potency of marijuana has increased, as has the amount of marijuana grown. Similarly, the war on drugs has not even been effective at reducing teenage use. According to the National Institute on Drug abuse 41.7% of 12th graders had tried marijuana in 1995. By 2008 this number rose to 42.6%.

Marijuana prohibition has clearly failed. Hiding eradication statistics and putting responsible people in jail will not change that.