Weed control

[palmspringsbum]

Weed control

Research on the medicinal benefits of marijuana may depend on good gardening--and some say Uncle Sam, the country's only legal grower of the cannabis plant, isn't much of a green thumb

The Boston Globe
By Jessica Winter | May 28, 2006


<img src=bin/netherlands_medical_greenhouse.bmp align=right title="A greenhouse in the Netherlands, where the cannabis grown for medicinal use is far more potent than that grown legally in the US.">LYLE CRAKER HAS a number of plants on his mind. An agronomist and professor in the Department of Plant, Soil & Insect Sciences at the University of Massachusetts, Amherst, he's currently analyzing the active ingredients in black cohosh, which is used to alleviate symptoms of menopause. He is also studying goldenseal, a native American plant that shows promise as a treatment for some skin irritations, and exploring the possibility that certain Chinese medicinal plants could be cultivated in Massachusetts for research purposes.

There is another medicinal plant that Craker would like to grow and study, but in this instance, his prospects will be determined in a courtroom. Since 2001, Craker has been seeking a license from the Drug Enforcement Administration to establish a medical-marijuana growth facility at UMass-Amherst. It would be the second such facility in the US; at present, the National Institute on Drug Abuse, a federal agency, produces the only legal supply of cannabis in the country at the University of Mississippi.

The DEA lists cannabis as a Schedule I drug, meaning that it has a high potential for abuse and no accepted medical uses. However, marijuana is unique on the Schedule I roster-which also includes cocaine, LSD, and MDMA (Ecstasy)-as the only substance that is not available from multiple independent producers for clinical research purposes.

``There are two issues here: quality and access," says Rick Doblin, the Belmont-based founder and president of the nonprofit <a href=http://www.maps.org/ title="MAPS WebSite" target=_blank>Multidisciplinary Association for Psychedelic Studies</a> (MAPS), which is sponsoring Craker's suit against the DEA. The government holds that its Mississippi operation obviates the need for a second crop. Craker and MAPS counter that NIDA cultivates a product of poor quality and does not make it readily available to qualified researchers, and point to NIDA's previous refusals to supply cannabis to two scientists with FDA-approved protocols as grounds for establishing an independent facility.

On April 20, the Food and Drug Administration released a controversial statement declaring that marijuana ``has no currently accepted medical use in treatment in the United States." The outcome of Craker's case-especially if it reaches federal court, as is likely-could realign the terms of the national debate over medical marijuana. For now, the suit, which has the expressed support of Senators Edward Kenedy and John Kerry, as well as 38 members of the House of Representatives, is in the hands of DEA Administrative Law Judge Mary Ellen Bittner, who's expected to make her recommendation to the agency on the application sometime this summer. Final briefs were filed on May 8.

There is abundant anecdotal evidence and personal testimony to support myriad uses of cannabis to treat symptoms of cancer, AIDS, multiple sclerosis, and other ailments. As the FDA reiterated in its statement, however, scant clinical evidence exists to back these claims-or, for that matter, to contradict them. Paradoxically, the controls on official research of cannabis in America undermine both the medical-marijuana movement's efforts to prove the drug's benefits and the government's assertions of its dangers. Strangely enough, the case for pharmaceutical cannabis may, in the end, come down to good gardening-and may depend on whether the government is willing to give up its monopoly on marijuana.

<center>. . .</center>

Cannabis sativa was once widely recommended by American physicians as a mild sedative, much as the popular herbal treatments valerian and camomile are used today. By 1937, however, the drug had been effectively outlawed by the Marihuana Tax Act. The Federal Bureau of Narcotics had aggressively pursued this ban with Congress, and cited marijuana's perceived popularity as a smoked narcotic among Mexican farm laborers, hysterical tabloid reports on its deranging effects, and results from tests on canine subjects.

Punishments for pot-related offenses remained light into the 1980s, and President Carter favored decriminalization. It wasn't until the War on Drugs gathered momentum midway through the Reagan administration that penalties became fearsome enough to drive marijuana growers indoors-which, it turned out, was the best possible place for a cannabis plant to thrive. In ``The Botany of Desire: A Plant's Eye View of the World" (2001), author Michael Pollan has an epiphany while visiting a ``grow room" run by an acquaintance. ``[I]t dawned on me," he writes, ``that this was what the best gardeners of my generation had been doing all these years: They had been underground, perfecting cannabis."

From the standpoint of both the scientist and the connoisseur, perfect cannabis can be achieved with unseeded, genetically identical female plants. The original crop is harvested from seeds, and subsequent generations are bred from cuttings. Characterized by the ``buds" from which marijuana derives one of its many slang names, these virgin female plants carry high levels of molecules unique to the cannabis plant, called cannabinoids. The two most well-understood cannabinoids are THC and CBD, which many physicians and patients believe can alleviate nausea, stimulate appetite, ease pain and anxiety, and lessen the muscle stiffness and spasms associated with MS.

In the UK, the GW Pharmaceuticals company has a government license to grow cannabis under highly regulated conditions. At a secret location in southern England, in greenhouses that are computer-controlled for temperature, humidity, and light, the GW research team has compiled a veritable library of plant strains, with precisely determined ratios of cannabinoid content.

The upshot is Sativex, a liquid extract of equal parts THC and CBD that is sprayed under the tongue to treat neuropathic pain. Britain permits the use of Sativex in MS patients, and the drug has been approved for marketing in Canada. Cannabinoids also have a presence on the US market, in the recently approved Cesamet, a synthetic cannabinoid, and in Marinol, a THC extract in pill form that the FDA approved back in 1985. But Marinol contains no CBD, and ingested THC is metabolized differently from smoked marijuana-the palliative effects take much longer to kick in, and the psychoactive effects are far stronger.

Craker's intentions for a Massachusetts site are similar to the GW template: an indoor facility housing female clones, with strains made to order for researchers according to exact cannabinoid content. In contrast to the methods practiced by GW and by America's outlaw gardeners, however, NIDA grows the majority of its marijuana outdoors, under conditions that result in unwanted pollination and, according to some users, a harsh product. The Institute harvested its most recent marijuana crop in Mississippi in 2002, and stockpiled the supply in vaults and freezers. Cannabinoid content of NIDA pot is highly variable, and a THC potency of 6 to 8 percent is about as high as researchers can hope for. By contrast, Canada distributes medical marijuana to patients at 12.5 percent, and medical marijuana in the Netherlands ranges from 13 to 18 percent potency.

``I've spoken to patients who have used [NIDA marijuana], and they've said it's everything from worthless to other descriptions I should not use," Craker says. ``The patient has to smoke one cigarette after the other to get any effective relief from pain." Ethan Russo, a neurologist and now a senior medical adviser to GW Pharmaceuticals, conducted patient studies with NIDA marijuana and reported, ``A close inspection of the contents of NIDA-supplied cannabis cigarettes reveals them to be a crude mixture of leaf with abundant stem and seed components.. . .The resultant smoke is thick, acrid, and pervasive."

Then again, it's not in NIDA's job description-or even, perhaps, in NIDA's interests-to grow a world-class marijuana crop. The institute's director, Nora Volkow, has stressed that it's ``not NIDA's mission to study the medicinal use of marijuana or to advocate for the establishment of facilities to support this research." Since NIDA's stated mission ``is to lead the Nation in bringing the power of science to bear on drug abuse and addiction," federally supported marijuana research will logically tilt toward the potential harms, not benefits, of cannabis.

Under these circumstances, evidence in support of medical marijuana tends to materialize as a byproduct, not a primary goal, of official research. For example, Donald Tashkin of UCLA intended to demonstrate via a NIDA-supported study that marijuana smoke increases the risk of lung and upper-airways cancer. But the findings of the study, announced this past week, indicate that heavy marijuana smokers actually show lower cancer rates than tobacco smokers, indirectly supporting claims by medical-marijuana proponents for the tumor-inhibiting properties of cannabinoids.

<center>. . .</center>

At the moment, federal law prohibits pot cultivation even in those states (11 at last count) that have passed medical-marijuana referenda. In 1996, Californians voted in favor of the Compassionate Use Act, also known as Proposition 215, which permitted the use and cultivation of marijuana by qualified patients. According to the act, patients with a referral from a physician can obtain medical marijuana from one of some 200 dispensaries or ``buyers' clubs," which procure their high-grade stock from tucked-away farms and discreet greenhouses. Despite the ever present threat of a crackdown from the federal government, these companies are thriving-some clubs even offer their employees healthcare benefits and 401(k) plans-and have created a market for medical marijuana.

``For evidence in support of the healthy competition fostered by a marketplace economy, you need only to look at the quality of marijuana available in California," says Mark Blumenthal, who directs the nonprofit American Botanical Council of Austin, Texas. ``Pluralism and economic competition are good for the consumer. We generally don't allow and empower monopolies in our culture-it's contrary to the tenets of our economic system."

The invocation of a government monopoly on marijuana helps to explain the strange bedfellows on the pro-cannabis side of this issue. The conservative historian Richard Brookhiser and the late Reagan aide Lyn Nofziger both spoke out in favor of medical marijuana, and supporters of Craker's suit against the DEA include not only several nurses' associations and the United Methodist Church but Grover Norquist, president of Americans for Tax Reform and a staunch defender of small government and an unfettered free market.

``The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors," Norquist wrote in his letter of support. ``This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."

Given Norquist's many successes on the lobbying circuit, perhaps all medical marijuana needs is a new pitch man.

<font siez=-1><i>Jessica Winter is a freelance journalist in New York. She writes for The Village Voice, the Guardian (UK), Time Out London, and other publications. </i></font>



© Copyright 2006 The New York Times Company

[budman]

Weed Watch

Orrin Hatch, Drug Law Reformer?

BY JORDAN SMITH
The Austin Chronicle
August 4, 2006


<table class=posttable align=right width=150><tr><td class=postcell><img class=postimg src=bin/hatch_orin.jpg title="Orin Hatch"></td></tr></table>Amid criticism suggesting that he's either a hypocrite or just plain off his rocker, Utah Sen. Orrin Hatch is "standing firm" in his decision to help R&B producer Dallas Austin shake a cocaine possession beef in the United Arab Emirates, reports The Salt Lake Tribune. Austin reportedly traveled to Dubai in May to attend a birthday bash for model Naomi Campbell and was popped by police for carrying just over a gram of coke – a charge that could've netted Austin more than a decade in a UAE prison. The producer pleaded guilty and spent two months in jail before he was finally sprung, with a little help from Hatch, last month. The Tribune reports that Hatch made several calls to the UAE consul in Washington, D.C., at the request of attorney and former Hatch staffer Nancy Taylor, whose law firm has represented both Austin – a Grammy-winning producer who has worked with Michael Jackson and Madonna, among others – and Hatch, who fancies himself a singer-songwriter (Hatch has released nine albums with song titles such as "Jesus' Love Is Like a River," "My God Is Love," and the ever-snappy "Heal Our Land: A Prayer for Our Country").

Hatch told reporters that his decision to intercede in the case was based on his "long-standing angst" with mandatory-minimum sentencing laws, which prescribe variously draconian prison terms for a host of crimes – many of them drug-related – without offering judges much leeway to reduce the terms based on a case's individual or mitigating circumstances. Taylor told the daily that she decided to ask for Hatch's help because he is "a very humanitarian person," but in a press statement, her law firm later downplayed Hatch's influence, writing that UAE officials stated that such a release is not uncommon when "the only victim [of the alleged crime] is the accused."

Nonetheless, Hatch took a beating from critics who said he was either setting a bad example by helping an admitted drug user or is a hypocrite for not using his influence to help thousands of similarly situated Americans who face similarly disproportionate man-min sentences in U.S. courts. "I go to court with those very same people every day, and the judges tell me Congress says we have to put you in prison, even for small amounts of drugs," Utah defense attorney Ron Yengich told the Tribune. "I wish that Senator Hatch and the Congress of the United States would understand this guy [Austin] isn't the exception, he is the rule."

<hr>
In other news, marijuana law reform advocates are anxiously awaiting a ruling from a Drug Enforcement Administration administrative law judge on whether the National Institute on Drug Abuse will be allowed to maintain a monopoly on growing and distributing pot for use in clinical research. The question has been hanging out there since 2004, when the DEA rejected an application – after sitting on it for more than three years – from the University of Massachusetts at Amherst that sought permission to grow pot for Food and Drug Administration-approved research. Granting such a request, the DEA opined, simply wouldn't "be consistent with the public interest."

The Multidisciplinary Association for Psychedelic Studies – a nonprofit research outfit that assists scientists with pot-related research – and U. Mass' Medicinal Plant Program Director Lyle Craker cried foul, challenging the DEA's decision. In testimony last year before Administrative Law Judge Mary Ellen Bittner, they argued that a U. Mass pot-production facility is in the public interest because it would encourage production of a better crop of test pot – researchers have increasingly complained about the poor quality of NIDA's stash, which reportedly makes accurate clinical testing difficult – and would "promote technological and scientific advancement in the field of medicine," reports the National Organization for the Reform of Marijuana Laws. "The DEA's refusal to permit me to grow marijuana for research necessarily prevents an accurate assessment of this plant's potential medical properties," Craker testified.

Unfortunately for researchers, even if Bittner rules in their favor, federal law would allow DEA head Karen Tandy to ignore the decision in the same manner that the DEA has, essentially, ignored research requests.

<hr>
Send drug war tips to jsmith@austinchronicle.com

[palmspringsbum]

Prof Gets Boost in Bid to Grow Marijuana

By KEVIN FREKING
The Washington Post
Monday, February 12, 2007; 10:18 PM


WASHINGTON -- Concluding that there is an inadequate supply of marijuana for medical research, an administrative law judge has recommended to the Drug Enforcement Administration that it grant a Massachusetts professor's application to grow the drug in bulk.

The judge's ruling is nonbinding. But officials at the American Civil Liberties Union hope that the recommendation to grant the application of Professor Lyle Craker will eventually lead to more research into the use of marijuana for medicinal purposes.

In June 2001, Craker submitted an application as a marijuana manufacturer to the DEA. However, the federal government limits the growing of marijuana available for clinical research to one source, the University of Mississippi.

Federal officials said that Craker's university, the University of Massachusetts Amherst, is free to compete for the next contract to produce research-grade marijuana for the United States. But there was no basis to add another producer.

The company that wants to fund Craker's facility for growing marijuana countered that researchers are not getting the quantity or the quality of marijuana needed to conduct research that is approved by the Food and Drug Administration.

The DEA contacted researchers and determined otherwise, so hearings were held in August and December of 2006 as Craker pursued the case. He got help from the ACLU along the way.

The administrative law judge, Mary Ellen Bittner, concluded Monday that granting Craker's application would be in the public interest. Among the reasons she cited were inadequate competition and an inadequate supply of marijuana for research purposes.

Steve Robertson, a spokesman for DEA, said Monday night the agency is reviewing Bittner's decision and would have no immediate comment. The DEA administrator, Karen Tandy, retains final authority to decide on the application.

"I hope that Administrator Tandy abides by the decision and grants me the opportunity to do my job unimpeded by drug war politics," Craker said in a statement distributed by the ACLU.

[palmspringsbum]

Judge backs professor's bid to grow marijuana

<span class=postbigbold>UMass could host nation's second lab</span>

By David Abel, Globe Staff | February 13, 2007
The Boston Globe

An administrative law judge recommended yesterday that a professor at the University of Massachusetts at Amherst be allowed to grow marijuana for research purposes, possibly making the state host to the nation's second laboratory authorized to grow the drug.

Professor Lyle Craker, a horticulturist who specializes in medicinal plants, has won support from both Senators Edward M. Kennedy and John F. Kerry in his effort to grow marijuana for research.

Marijuana is now only legally grown at the University of Mississippi, but Craker has argued that the drug grown there is neither potent enough nor readily available to researchers.

In her opinion, which can be overruled by the US Drug Enforcement Administration, Judge Mary Ellen Bittner said Craker's bid to grow marijuana "would be in the public interest."

"There would be minimal risk of diversion of marijuana," she wrote. "There is currently an inadequate supply of marijuana available for research purposes . . . [and] competition in the provision of marijuana for such purposes is inadequate."

In a phone interview, Craker said he had not read the 87-page opinion. "I understand it's favorable, and that's good," he said.

Rick Doblin -- president of the Multidisciplinary Association for Psychedelic Studies, a drug research group based in Belmont that hopes to sponsor Craker's work -- called the decision "a major turning point."

"This is a major step to getting us to do the scientific research that the government has been blocking for the past 30 years," Doblin said. "If the government says no, the hypocrisy of their approach will help fuel efforts for state medical marijuana reforms."

Garrison Courtney, a DEA spokesman, declined to comment on the ruling. "We're still reviewing the opinion," he said. "We'll make a determination at a later point."

Craker first applied to the DEA for permission to grow marijuana in 2001. Kennedy and Kerry later wrote a letter to the DEA, saying that the Mississippi lab had an "unjustified monopoly."

In 2004, Craker and the Multidisciplinary Association for Psychedelic Studies sued the government in federal court, charging the DEA with unreasonable delays.

The DEA promptly rejected their bid. In 2005, Craker and the group sought the opinion from an administrative law judge.

If the DEA's administrator decides to reject Bittner's recommendation, Doblin said Craker and the group would file another lawsuit in federal court.

[palmspringsbum]

Posted on Tue, Feb. 13, 2007


Judge: Medical researchers need more pot

By Michael Doyle
McClatchy Newspapers


WASHINGTON - Medical researchers need more marijuana sources because government supplies aren't meeting scientific demand, a federal judge has ruled.

In an emphatic but nonbinding opinion, the Drug Enforcement Administration's own judge is recommending that a University of Massachusetts professor be allowed to grow a legal pot crop. The real winners could be those suffering from painful and wasting diseases, proponents believe.

"The existing supply of marijuana is not adequate," Administrative Law Judge Mary Ellen Bittner ruled.

The federal government's 12-acre marijuana plot at the University of Mississippi provides neither the quantity nor quality scientists need, researchers contend. While Bittner didn't embrace those criticisms, she agreed that the system for producing and distributing research marijuana is flawed.

"Competition in the manufacture of marijuana for research purposes is inadequate," Bittner determined.

Bittner further concluded that there is "minimal risk of diversion" from a new marijuana source. Making additional supplies available, she stated, "would be in the public interest."

The DEA isn't required to follow Bittner's 88-page opinion, and the Bush administration's anti-drug stance may make it unlikely that the grass-growing rules will loosen. Both sides can now file further information before DEA administrators make their ruling.

"We could still be months away from a final decision," DEA spokesman Garrison Courtney said Tuesday, adding that "obviously, we're going to take the judge's opinion into consideration."

Still, the ruling is resonating in labs and with civil libertarians.

"(The) ruling is an important step toward allowing medical marijuana patients to get their medicine from a pharmacy just like everyone else," said Allen Hopper, an attorney with the American Civil Liberties Union.

Based in the California seaside town of Santa Cruz, the ACLU's Drug Law Reform Project has been representing University of Massachusetts scientist Lyle Craker. Since 2001, Craker has been confronting numerous bureaucratic and legal obstacles in his request for permission to grow research-grade marijuana.

An agronomist with a doctorate from the University of Minnesota, Craker was asked to grow bulk marijuana by a small, five-member group called the Multidisciplinary Association for Psychedelic Studies. The psychedelic studies group wants to research such areas as developing vaporizers that can efficiently deliver pot smoke.

"This ruling is a victory for science, medicine and the public good," Craker said. "I hope that the DEA abides by the decision and grants me the opportunity to do my job unimpeded by drug war politics."

The latest research made public this week indicated that marijuana provided more pain relief for AIDS patients than prescription drugs did. The Bush administration quickly dismissed those findings as a "smokescreen," and it has remained hostile to Craker's research efforts.

During the trial, for instance, DEA attorneys secured an admission from Multidisciplinary Association for Psychedelic Studies head Richard Doblin that he has smoked marijuana regularly since 1971.

"Can you tell us the source of this marijuana?" DEA attorney Brian Bayly asked Doblin, before withdrawing the question under objections.

The DEA originally claimed that it lost Craker's research application. Then the agency said that his photocopied follow-up lacked a necessary original signature. After a year, Craker tried again. He then had to wait another year before the DEA started processing the application, in which he proposed to grow about 25 pounds of marijuana in the first year.

Craker sued after the agency rejected his application. That brought his case before Bittner.

She oversaw the trial, which featured witnesses such as former California legislator John Vasconcellos.

"People have a right to know more about what might help them in their suffering and pain or illness, whatever it might be," Vasconcellos testified, in words repeated by Bittner. "The more research, the better."

The University of Mississippi has monopolized government-grade marijuana since 1968. The university also contracts with North Carolina's Research Triangle Institute, which runs a machine that can roll up to 1,000 finished marijuana cigarettes in an hour.

The government-grown pot is too "harsh" and filled with stems and seeds, researchers testified.

"The material was of such poor quality, we did not deem it to be representative of medical cannabis," researcher Dr. Ethan Russo said.

[palmspringsbum]

DEA Judge Supports Medical Marijuana Research


The North County Gazette
February 13, 2007

WASHINGTON - The American Civil Liberties Union applauded a ruling issued by a U.S. Drug Enforcement Administration judge that recommends ending the federal government's 65- year monopoly on the supply of marijuana available for Food and Drug Administration-approved medical research.

The ACLU represents University of Massachusetts-Amherst Professor Lyle Craker, who petitioned the Drug Enforcement Administration (DEA) for a license to grow research-grade marijuana for use in privately-funded studies that aim to develop the plant into a legal, prescription medicine. The DEA judge ruled that it is in the public interest to end the federal National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana that can be used in Food and Drug Administration (FDA)-approved research.

"For too long the DEA has inappropriately inserted politics into a regulatory process that should be left to the FDA and medical science," said Allen Hopper, an attorney with the ACLU Drug Law Reform Project. "We are pleased that the judge has recommended an end to the federal government's blockade of medical marijuana research."

The DEA must now either accept or reject the court's recommendation, and scientists, doctors and medical marijuana patients nationwide joined the ACLU in urging the agency to comply with the court's finding and halt federal obstruction of medical marijuana research.

"This ruling is a victory for science, medicine and the public good," said Professor Craker. "I hope that the DEA abides by the decision and allows the work to go forward unimpeded by drug war politics." The ruling issued Monday, Feb. 12 by U.S. Department of Justice-appointed Administrative Law Judge Mary Ellen Bittner marks a major step forward in the six year struggle by Professor Craker to gain a DEA license to grow research-grade marijuana for use by other scientists in privately funded, government-approved studies.

Following nine days of hearings, testimony and evidence from both sides, including from researchers who reported that the government denied their requests for marijuana for use in FDA-approved research protocols, Judge Bittner concluded, "that there is currently an inadequate supply of marijuana available for research purposes…" and that, "Respondent's registration to cultivate marijuana would be in the public interest."

Thirty-eight members of Congress and a broad range of scientific and medical organizations have joined Professor Craker in challenging the federal government's policy of blocking administrative channels and obstructing research that could lead to the development of marijuana as a prescription medicine. These organizations include the Lymphoma Foundation of America, the National Association for Public Health Policy, the Multiple Sclerosis Foundation, as well as several state medical and nurses' associations.

Marijuana is the only Schedule I drug that DEA has prohibited from being produced by private laboratories for scientific research. Other controlled substances, including LSD, MDMA (also known as "Ecstasy"), heroin and cocaine, are available to researchers from DEA-licensed private laboratories, such as the one Professor Craker plans to establish.

In contrast, NIDA has remained scientists' sole source of marijuana, despite criticism over the agency's refusal to make marijuana available for all FDA-approved research into the plant's potential medical value. The ACLU and others point out that such research conflicts with NIDA's mission to study the harmful effects of drugs of abuse. In addition, researchers report that marijuana available through NIDA is of low quality and variety and is not optimized to meet FDA standards for prescription drug development.

Professor Craker's proposed facility to grow high-quality medical marijuana for research purposes will be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit pharmaceutical company with plans to develop marijuana into a fully legal, prescription medication.

"For decades, we've been told by the politicians that marijuana has no proven medical value while scientists have been denied the ability to prove otherwise," said Rick Doblin, Ph.D., president and founder of MAPS. "Hopefully, today's decision marks a shift towards science, not politics, guiding medicine in America." Despite federal prohibition, 12 states have enacted legislation protecting patients who use medical marijuana with a physician's recommendation from prosecution under state law, and national polls consistently find that roughly 75 percent of Americans support the use of medical marijuana.

"Today's ruling is an important step toward allowing medical marijuana patients to get their medicine from a pharmacy just like everyone else," added the ACLU's Hopper. "That would clear up the controversies surrounding state medical marijuana laws."

The ACLU is co-counsel in the case, In the Matter of Lyle Craker, with Julie Carpenter at the Washington D.C. law firm Jenner & Block, LLP and is assisted by Steptoe & Johnson, LLP.

Judge Bittner's ruling in support of Professor Craker's petition is available at: www.aclu.org/drugpolicy/medmarijuana/28 ... 70212.html

Complete background on the case, including client profiles, hearing transcripts, a full selection of legal documents, and letters of support from lawmakers and scientists can be found at: www.aclu.org/drugpolicy/medicalmarijuan ... index.html 2-13-07

[palmspringsbum]

DEA rejects UMass request to grow medical marijuana


By Bina Venkataraman, Globe Correspondent
The Boston Globe, January 12, 2009

The US Drug Enforcement Administration has rejected the bid of a UMass Amherst researcher who wants to create the second laboratory in the nation authorized to grow marijuana for medical research.

The ruling released today came nearly two years after a federal administrative law judge recommended that Lyle Craker, a horticultural professor who specializes in medicinal plants, be allowed to grow marijuana for medical research. The DEA decision, which is a final rule not subject to public comment, called the current supply of marijuana for research "adequate and uninterrupted,” and said that a second laboratory would not be in the public interest.

Since 1968, a federally approved laboratory at the University of Mississippi’s School of Pharmacy has grown nearly a hundred varieties of marijuana plants. Access to the plants has been limited to researchers who gain federal permits, and plants from the lab’s farm have been used for clinical studies across the country to test marijuana for treating glaucoma, pain, nausea, and other illnesses.

But some researchers complain that access to the laboratory's supply is thwarted by a contract the lab holds with the National Institute on Drug Abuse, which must approve permits issued by the Food and Drug Administration or the DEA in a process that can take months to complete. Other drugs listed by the DEA as "Schedule 1," such as heroin and ecstasy, do not require this additional approval for researchers to access them.

Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies, a Belmont-based drug research group that wants to fund Craker’s marijuana cultivation and sponsored the lawsuit that spurred the administrative law judge’s recommendation in 2007, calls the Mississippi lab a "monopoly."

Doblin said that his group will now either file another lawsuit or appeal to the incoming Obama administration to reverse the decision. "We’re not giving up," he said.

Craker, who first applied for the DEA permit in 2001, said he was disappointed that the agency appears to want to limit medicinal marijuana research. "We’ve seen a big upsurge in the use of medicinal plants to treat illnesses," he said.

DEA spokesman Garrison Courtney said the agency had no additional comment on the decision other than what was written in the ruling.

[palmspringsbum]

The DEA says no (again) to medical marijuana. Now what?

<span class=postbigbold>High on Obama?</span>

By MIKE MILIARD | January 14, 2009 | The Phoenix

Rick Doblin, president of Belmont-based Multidisciplinary Association for Psychedelic Studies (MAPS), can't believe how long it's dragged on. Since 2001, Dr. Lyle Craker, a UMass professor of plant and soil sciences, has sought, with MAPS's help, to be licensed by the Drug Enforcement Administration (DEA) to grow a crop of research-grade marijuana with an eye toward Food and Drug Administration–approved studies into its efficacy as a prescribable medicine. (See "The Right to Grow," August 26, 2005.)

In 2004, the DEA rejected Craker's petition to grow plants that could be studied in place of the poor-quality and parsimoniously distributed federal crop maintained by the National Institute on Drug Abuse (NIDA). The following year, Craker, along with MAPS and the American Civil Liberties Union's Drug Law Reform Project, challenged that decision with extensive testimony before an administrative-law judge who eventually ruled, in a formal but non-binding 2007 recommendation, that Craker should be allowed to proceed.

Now, two years later, as the Bush administration sputters to its end, the DEA has taken a parting shot against science, rejecting that opinion and refusing Craker's license.

If the decision is galling, it's not at all surprising. In fact, says MAPS president Rick Doblin, one news-wire service told him they viewed this as a non-story "because we already know the DEA is against medical marijuana."

But, of course, just days from now, we'll have a new sheriff in town. What then?

"That's what we don't know," says Doblin. Clearly. "The Bush administration decided that they would make it a lot harder for the Obama administration and the DEA [to change course] under whatever new leadership they get."

And while Doblin is heartened by the leftward tack an Obama administration will surely represent on most issues, he's much more circumspect when it comes to drug policy.

For one thing, Obama's purported first choice to lead the Office of National Drug Control Policy (ONDCP) was less than inspiring. James Ramstad — a former GOP congressman who's voted against medical marijuana and needle-exchange programs — provoked such an outcry from progressives that his appointment appears to have been scotched. (On Monday, Bush appointed ONDCP Acting Director Patrick Ward to serve as the so-called Drug Czar until Obama makes his pick.)

So, even as heartening state-level legislative efforts continue apace, Doblin says he's taking a "wait-and-see approach" when it comes to federal policy.

But despite Obama's welcome signals that he intends to depoliticize his administration's approach to science, such a commitment may, at least in the early going, be hamstrung by a lack of political will. Doblin says one of Obama's science advisors, asked about medical marijuana, told him: "Good luck, but this isn't something that we're necessarily gonna take up."

[palmspringsbum]

Weekend Edition
January 16-18, 2009

DEA Nixes Challenge to Ole Miss Monopoly
<span class=postbigbold>Growing Pot for Research</span>

By FRED GARDNER

Guns blazing as they head for the exit, the Bush gang has blasted the hopes of Lyle Craker, a UMass Amherst botany professor who applied in June, 2001 for a DEA license to grow marijuana for FDA-approved medical research. On Jan. 12 Craker got a formal letter of denial from DEA Administrator Michele Leonhartt. Mahmoud ElSohly of the University of Mississippi remains America's only legal grower, as far as the feds are concerned.

Some of the destructive regulations promulgated by Bush in recent months may be reversible, but the DEA's rejection of Craker appears to be final. Lawyers are exploring the appeal options, according to Rick Doblin, who organized legal and political support for Craker. Doblin didn’t sound optimistic on the phone Jan. 13.

Prof. Craker has already won an appeal —but it didn't count, as we shall explain. His application had been rejected by the DEA in December, 2004, following a three-and-a-half year "evaluation process." With pro-bono help from DC lawyers and the ACLU, he appealed. An extensive hearing was conducted by Administrative Law Judge Mary Ellen Bittner at DEA headquarters in Arlington. Team Craker argued that "the current system does not provide an adequate and uninterrupted supply of marijuana for legitimate purposes," and "creating an alternative to the current NIDA-controlled monopoly would promote the advancement of science and research by adding competition without increasing the risk of diversion."

The DEA called ElSohly, who spent December 13 and 14, 2005, defending his monopoly. His testimony was revealing. Much of his work for the government involves testing the potency of thousands of marijuana samples seized by law enforcement agencies throughout the country. On his own time, presumably, he has patented a THC-extract suppository, which a corporation called Insys is trying to market. (Can they think of a better slogan than “Up yours, America?”) El Sohly also has a contract with Mallinckrodt, a giant chemical company that plans to market a THC-extract pill as an alternative to Marinol (which is synthetic THC in prescribable pill form).

ElSohly testified that the marijuana he grows for NIDA meets all the needs of U.S. researchers. His most recent crop, grown in the summer of 2002, averaged about 7% THC. It was stored in drums lined with plastic in refrigerated vaults. Upon getting word from NIDA that a researcher’s request had been granted, ElSohly sends a batch to the Research Triangle Institute in North Carolina to be machine-rolled into cigarettes.

ElSohly testified that marijuana higher than 8% THC would gum up the rolling machines. Moreover, he said, administrators from the University of California's Center for Medicinal Cannabis Research had advised him that patients in clinical trials could not tolerate marijuana with THC content above 8%. That's a dubious claim. In any case, one puff of an 8% THC cigarette provides the same amount as two puffs a of 4%-THC cig. Clinical trial protocols can be adjusted accordingly.

One of the recipients of ElSohly's NIDAwanna is Irvin Rosenfeld, a Ft. Lauderdale stockbroker whose rare bone disorder qualified him for the "Investigational New Drug Program" launched by the feds in the Carter era (and closed to new patients by Poppy Bush when AIDS patients began applying en masse at the start of the '90s). "I had a strong personal interest in ElSohly's testimony," writes Rosenfeld in a forthcoming memoir. "If the quality of government-issued medicine improved, I could smoke less, and the mild side effects would be even milder.

“An aspect of medical marijuana use that the Drug Czar and other Prohibitionists won't acknowledge is: the higher the concentration of THC and other active ingredients, the smaller the amount required by the patient. If the main adverse effect is damage to lung tissue —as Ethan Russo and other researchers have found— then the less a patient has to smoke, the better. Nevertheless, the government regularly issues warnings that 'today's pot is much stronger than pot in the 1970s...' as if that made it more dangerous instead of more efficient!"

One of ElSohly's self-serving contentions was that all marijuana studies should be conducted with material similar in potency to the national average. "What makes sense," he said, "is to look at the national data for potency, for what's out there on the street, and… mimic what's out there and to do research with those kinds of materials."

That approach would be reasonable if the focus of research was harm, not medical benefit; and indeed, almost all the marijuana research NIDA has sponsored over the years has been aimed at finding adverse effects. For those studies, using marijuana comparable to what most Americans are smoking might make sense. But for research aimed at finding beneficial effects, scientists should be provided with the highest-grade strains, not the national average.

Judge Bittner was not impressed by ElSohly's arguments. On Feb.12, 2007, she issued her opinion, which concluded that competition among producers would be in the public interest. DEA lawyers had argued that the existing arrangement involved competition because Craker (and others) could submit a bid against ElSohly every five years when the NIDA contract came up for renewal. Bittner observed, "The NIDA contract requires the contractor to analyze samples of marijuana supplied by law enforcement agencies, a separate activity from cultivating marijuana for research purposes, and a requirement a qualified cultivator may not be able to fulfill."

So Craker won his appeal… but when the name of the game is Administrative Law, nobody wins except the government agency. The judge doesn't decide how the agency must act, her opinion is merely a recommendation that the agency chief can accept, reject, or modify. DEA Administrator Leonhartt and her predecessor, Karen Tandy, sat on ALJ Bittner's opinion for 23 months, and then shot it down, along with the hopes of many drug policy reformers. The record contained letters of support for Craker from Massachusetts Senators John Kerry and Ted Kennedy and 45 members of Congress. "As each day got closer to January 20," Doblin said ruefully, "I couldn't help thinking they might punt it over to the Obama Administration."

Granting a license to a second grower of marijuana for federally approved research seems like the kind of small step away from prohibition that the Obama Administration might be willing to make.
As this goes off to CounterPunch Jan. 15 —the day the DEA decision re Craker was published in the Federal Register— Rick Doblin reports that the lawyers see a ray of hope: “DEA makes a big deal in their final ruling that rejection of the FDA-approved protocols of Donald Abrams and Ethan Russo took place before the current HHS Guidelines were issued. DEA claims that since no rejections have taken place after the guidelines were in force, there is no evidence that it is difficult or impossible for an FDA-approved researcher to obtain marijuana from NIDA. The HHS 1999 Guidelines were issued May 21, 1999. Russo’s protocol was approved by FDA in September 1999 and rejected by NIDA/HHS in December 1999, with the written rejection received in February 2000. We may submit this as new evidence."

<span class=postbold>A Note on the Coverage</span>

A brief story about the DEA turning down Craker ran in the Boston Globe Jan. 13. It made no reference to the political significance of the timing. Reporter Bina Venkataraman portrayed the whole process and outcome as quite rational: "The DEA decision called the current supply of marijuana for research 'adequate and uninterrupted' and said a second laboratory would not be in the public interest. Since 1968, a federally approved laboratory at the University of Mississippi's School of Pharmacy has grown nearly a hundred varieties of marijuana plants... The plants have been used for clinical studies across the country."

Venkataraman made Rick Doblin out to be a bit of a spinmeister: "Doblin... calls the Mississippi lab a monopoly." When one company controls all the business, it is a monopoly. She falsely summarized and minimized criticisms of ElSohly's operation: "Some researchers complain that access to the laboratory's supply is thwarted by a contract it holds with the National Institute on Drug Abuse, which must approve permits issued by the Food and Drug Administration or the DEA in a process that can take months to complete." Months? The right word would have been "years" or "a lifetime.” And would-be researchers have many complaints in addition to the length of the approval process.

By some strange coincidence —or was it the Ol’ Miss p.r. machine, or NIDA's?— the New York Times ran a flattering interview with ElSohly on Dec. 23, shortly before the DEA announced it was upholding his monopoly. No mention was made of Craker’s application or ElSohly’s opposition to it. I emailed the interviewer, Claudia Dreifus, to ask at whose initiative the piece was written, but didn't hear back. I met Claudia in New York in 1970. She had just published an article about A.J. Weberman, who used to go through Bob Dylan's garbage cans on MacDougal Street. One time Dylan, who had a family and his own privacy to protect, caught Weberman and dealt with him appropriately. Weberman shared his happy recollection of the encounter with Claudia: "All I could think of was 'Bob Dylan is beating the shit out of me.'"

Here she is, all these years later, a professor at Columbia University and a regular in the New York Times Science section, lobbing softballs to Mahmoud ElSohly. Comments in italics are by your correspondent.

<span class=postbold>Dreifus: What exactly does the Marijuana Project do?</span>

ElSohly: At this laboratory, which began in 1968, we often investigate marijuana's chemistry. We also have a farm where we grow cannabis for federally approved researchers. Our material is employed in clinical studies around the country, to see if the active ingredient in this plant is useful for pain, nausea, glaucoma, for AIDS patients and so on.

The image is of a panoply of clinical trials being conducted in the U.S. —a key point The DEA Administrator made in rejecting Craker’s application.

Dreifus: One of the basic principles of agronomy is to start with good seeds. Where do your seeds come from?

ElSohly. That's a very good question.

Patronizing. He realizes she's not a science whiz.

Most of the illicit material in the 1960s came from Mexico. So, in collaboration with the D.E.A. and the Mexican government, we acquired those seeds. Later, we acquired others from Colombia, Thailand, Jamaica, India, Pakistan and places in the Middle East. That permitted us to study chemical and botanical differences. By 1976, we were growing about 96 different varieties.

Interestingly, that led us to see that there was only one species of cannabis. It had always been thought that there were many. But you could see that the chemistry of this plant is the same qualitatively no matter where it comes from.

He’s claiming undue credit. The one-species theory dates back to Linnaeus The modern paper usually cited in this regard is: Small, Beckstead and Chan. 1975. The evolution of cannabinoid phenotypes in Cannabis. Economic Botany 29:219-232. All three authors were based in Canada, grew their own plants and ran their own analytic lab tests.

What makes each different is the relative proportion of the different chemicals in there, which doesn't make a different species. It's really the same species, but different varieties of it. The different types of varieties hybridize very easily.

Dreifus: Does this mean that one could make genetically modified cannabis?

ElSohly: Yes. Absolutely. That actually has been the trend over the years in the cultivation in the illicit market, and also in the legal market, where we are doing genetic selection, where we select specific materials that have the genes that produce higher levels of THC or some of the other ingredients.

Apparently she means to invoke Monsanto-style Frankenfood genetic modification and he's talking about Mendelian genetics and selective breeding.

Dreifus: So out there in rural Northern California, have they been improving their crops with modern genetics?

ElSohly: They have been doing genetic selection for years. You can see the potency keeps going up. In the 1970s, the seized marijuana had probably 1 percent or less of the active ingredient. Now, it's about 8 percent, on the average.

Some enlightened California dispensary operators have begun using an analytic test lab to determine cannabinoid levels and to check for the presence of mold. According to Steve DeAngelo of Oakland's Harborside Dispensary, "The cannabis that an experienced user would consider ordinary, we're finding, is in the 10%-THC range. Cannabis considered strong would be 20%-THC or higher."

Dreifus: How did you come to your unusual specialty?

ElSohly: The honest truth is

Don't you always tell it like it is, Dr. ElSohly?

that it began out of necessity. In 1975, while I was in my last year of graduate school in natural products chemistry at the University of Pittsburgh, the Lord provided me with twin daughters...

Didn't Mrs. E. have anything to do with it?

Sorry to sound catty. I’ve met ElSohly’s family, his offspring seemed well-adjusted and gorgeous. But his defense of his monopoly has been unseemly, to put it mildly, and the role of the corporate media in upholding marijuana prohibition is reprehensible. Their basic trick is to cover the subject sporadically, assigning reporters who have to make a fast, superficial study of the subject and can barely understand, let alone convey, the connections between legal, political, and scientific developments... Note how assertions made by ElSohly to Claudia D. wound up in the reporting of Bina V... The Times owns the Globe. Maybe they’re applying economies of scale, saving money on facts.

<small>Fred Gardner can be reached at plebesite.com</small>