White House Report Acknowledges Few Scientists Permitted To Assess Cannabis Use In Humans

Posted by Ninja Smoker at 9:02 am on July 22, 2011

http://www.theweedblog.com/white-house-report-acknowledges-few-scientists-permitted-to-assess-cannabis-use-in-humans/

Only fourteen researchers in the United States are legally permitted to conduct research assessing the effect of inhaled cannabis in human subjects, according to data included in the White House’s 2011 National Drug Control Strategy, released last week.

In a section of the report entitled ‘Medical Marijuana,’ the administration states, “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.” However, it later clarifies that of these 109 scientists, only fourteen “are approved to conduct research with smoked marijuana on human subjects.”

Among those scientists licensed to work with either cannabis or its constituents — primarily in animal models — most are involved in research to assess the drug’s “abuse potential, physical/psychological effects, [and] adverse effects,” the report stated.

In 2010, a spokesperson for the US National Institute on Drug Abuse (NIDA) — the federal agency that must approve any US clinical trial involving marijuana – told the New York Times: “[O]ur focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

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

Commenting on the report, NORML Deputy Director Paul Armentano said: “Only in an environment of absolute criminal prohibition would this or any administration purport to the public that it is acceptable to allow no more than fourteen researchers to clinically study a substance consumed by tens of millions of Americans for therapeutic or recreational purposes. This acknowledgement illustrates once again the administration’s supposed commitment to ‘scientific integrity’ does not apply to cannabis.”

For more information, please contact Allen St. Pierre, NORML Executive Director, at (202) 483-5500 or Paul Armentano, NORML Deputy Director at: paul@norml.org.

Top 10 Cannabis Studies The Government Wishes It Didn’t Fund

10) MARIJUANA USE HAS NO EFFECT ON MORTALITY:
A massive study of California HMO members funded by the National Institute on Drug Abuse (NIDA) found marijuana use caused no significant increase in mortality. Tobacco use was associated with increased risk of death. Sidney, S et al. Marijuana Use and Mortality. American Journal of Public Health. Vol. 87 No. 4, April 1997. p. 585-590. Sept. 2002.
9) HEAVY MARIJUANA USE AS A YOUNG ADULT WON’T RUIN YOUR LIFE:
Veterans Affairs scientists looked at whether heavy marijuana use as a young adult caused long-term problems later, studying identical twins in which one twin had been a heavy marijuana user for a year or longer but had stopped at least one month before the study, while the second twin had used marijuana no more than five times ever. Marijuana use had no significant impact on physical or mental health care utilization, health-related quality of life, or current socio-demographic characteristics. Eisen SE et al. Does Marijuana Use Have Residual Adverse Effects on Self-Reported Health Measures, Socio-Demographics or Quality of Life? A Monozygotic Co-Twin Control Study in Men. Addiction. Vol. 97 No. 9. p.1083-1086. Sept. 1997
8) THE “GATEWAY EFFECT” MAY BE A MIRAGE:
Marijuana is often called a “gateway drug” by supporters of prohibition, who point to statistical “associations” indicating that persons who use marijuana are more likely to eventually try hard drugs than those who never use marijuana – implying that marijuana use somehow causes hard drug use. But a model developed by RAND Corp. researcher Andrew Morral demonstrates that these associations can be explained “without requiring a gateway effect.” More likely, this federally funded study suggests, some people simply have an underlying propensity to try drugs, and start with what’s most readily available. Morral AR, McCaffrey D and Paddock S. Reassessing the Marijuana Gateway Effect. Addiction. December 2002. p. 1493-1504.

7) PROHIBITION DOESN’T WORK (PART I):
The White House had the National Research Council examine the data being gathered about drug use and the effects of U.S. drug policies. NRC concluded, “the nation possesses little information about the effectiveness of current drug policy, especially of drug law enforcement.” And what data exist show “little apparent relationship between severity of sanctions prescribed for drug use and prevalence or frequency of use.” In other words, there is no proof that prohibition – the cornerstone of U.S. drug policy for a century – reduces drug use. National Research Council. Informing America’s Policy on Illegal Drugs: What We Don’t Know Keeps Hurting Us. National Academy Press, 2001. p. 193.

6) PROHIBITION DOESN’T WORK (PART II):
(DOES PROHIBITION CAUSE THE “GATEWAY EFFECT”?): U.S. and Dutch researchers, supported in part by NIDA, compared marijuana users in San Francisco, where non-medical use remains illegal, to Amsterdam, where adults may possess and purchase small amounts of marijuana from regulated businesses. Looking at such parameters as frequency and quantity of use and age at onset of use, they found no differences except one: Lifetime use of hard drugs was significantly lower in Amsterdam, with its “tolerant” marijuana policies. For example, lifetime crack cocaine use was 4.5 times higher in San Francisco than Amsterdam. Reinarman, C, Cohen, PDA, and Kaal, HL. The Limited Relevance of Drug Policy: Cannabis in Amsterdam and San Francisco. American Journal of Public Health. Vol. 94, No. 5. May 2004. p. 836-842.

5) OOPS, MARIJUANA MAY PREVENT CANCER (PART I):
Federal researchers implanted several types of cancer, including leukemia and lung cancers, in mice, then treated them with cannabinoids (unique, active components found in marijuana). THC and other cannabinoids shrank tumors and increased the mice’s lifespans. Munson, AE et al. Antineoplastic Activity of Cannabinoids. Journal of the National Cancer Institute. Sept. 1975. p. 597-602.

4) OOPS, MARIJUANA MAY PREVENT CANCER, (PART II):
In a 1994 study the government tried to suppress, federal researchers gave mice and rats massive doses of THC, looking for cancers or other signs of toxicity. The rodents given THC lived longer and had fewer cancers, “in a dose-dependent manner” (i.e. the more THC they got, the fewer tumors). NTP Technical Report On The Toxicology And Carcinogenesis Studies Of 1-Trans- Delta-9-Tetrahydrocannabinol, CAS No. 1972-08-3, In F344/N Rats And B6C3F Mice, Gavage Studies. See also, “Medical Marijuana: Unpublished Federal Study Found THC-Treated Rats Lived Longer, Had Less Cancer,” AIDS Treatment News no. 263, Jan. 17, 1997.

3) OOPS, MARIJUANA MAY PREVENT CANCER (PART III):
Researchers at the Kaiser-Permanente HMO, funded by NIDA, followed 65,000 patients for nearly a decade, comparing cancer rates among non-smokers, tobacco smokers, and marijuana smokers. Tobacco smokers had massively higher rates of lung cancer and other cancers. Marijuana smokers who didn’t also use tobacco had no increase in risk of tobacco-related cancers or of cancer risk overall. In fact their rates of lung and most other cancers were slightly lower than non-smokers, though the difference did not reach statistical significance. Sidney, S. et al. Marijuana Use and Cancer Incidence (California, United States). Cancer Causes and Control. Vol. 8. Sept. 1997, p. 722-728.

2) OOPS, MARIJUANA MAY PREVENT CANCER (PART IV):
Donald Tashkin, a UCLA researcher whose work is funded by NIDA, did a case-control study comparing 1,200 patients with lung, head and neck cancers to a matched group with no cancer. Even the heaviest marijuana smokers had no increased risk of cancer, and had somewhat lower cancer risk than non-smokers (tobacco smokers had a 20-fold increased lung cancer risk). Tashkin D. Marijuana Use and Lung Cancer: Results of a Case-Control Study. American Thoracic Society International Conference. May 23, 2006.

1) MARIJUANA DOES HAVE MEDICAL VALUE:
In response to passage of California’s medical marijuana law, the White House had the Institute of Medicine (IOM) review the data on marijuana’s medical benefits and risks. The IOM concluded, “Nausea, appetite loss, pain and anxiety are all afflictions of wasting, and all can be mitigated by marijuana.” While noting potential risks of smoking, the report added, “we acknowledge that there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting.” The government’s refusal to acknowledge this finding caused co-author John A. Benson to tell the New York Times that the government “loves to ignore our report … they would rather it never happened.” Joy, JE, Watson, SJ, and Benson, JA. Marijuana and Medicine: Assessing the Science Base. National Academy Press. 1999. p. 159. See also, Harris, G. FDA Dismisses Medical Benefit From Marijuana. New York Times. Apr.
21, 2006

Government Forced NCI To Censor Medical Cannabis Facts

Graphic: NORML Stash Blog

Fuck censorship.

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In March, the National Cancer Agency (NCI), a component agency of the National Institutes of Health, acknowledged the medicinal benefits of marijuana in its online treatment database. But the information only stayed up a few days, before it was scrubbed from the site.

Now, newly obtained documents reveal not only how NCI database contributors arrived at their March 17 summary of marijuana’s medical uses, but also the furious politicking that went into quickly scrubbing that summary of information regarding the potential tumor-fighting effects of cannabis, reports Kyle Daly at the Washington Independent.

Phil Mocek, a civil liberties activist with the Seattle-based Cannabis Defense Coalition, obtained the documents as a result of a Freedom Of Information Act (FOIA) request he filed in March after reading coverage of the NCI’s action. Mocek has made some of the hundreds of pages of at-times heated email exchanges and summary alterations available on MuckRock, a website devoted to FOIA requests and government documents.

The treatment database on NCI’s website is called the Physician Data Query (PDQ). The PDQ entry on cannabis and cannabinoids is maintained by the Complementary and Alternative Medicine (CAM) Editorial Board. The lead reviewer on the marijuana summary statement is CAM board member Donald Abrams, director of integrative oncology at the University of California-San Francisco cancer center.

Abrams advocates the use of cannabis in cancer treatment, and his wish to accurately portray its medical applications becomes clear early in the documents.

On March 24, just a week after the finished summary had gone online, Susan Weiss — chief of the Office of Science Policy and Communications within the National Institutes on Drug Abuse (NIDA) — sent NCI officials an email saying her agency had just become aware of the summary. Weiss told them the NIDA wanted the summary changed to acknowledge that the FDA hasn’t approved marijuana; to take away any implication that it was recommending prescribing marijuana; to highlight the supposed “addiction potential” of marijuana; and to link to the NIDA’s own page on the supposed “adverse effects of marijuana.”

The NCI balked at the last two requests: ”I am unaware of any convincing evidence indicating that marijuana is addictive,” communications officer Rick Manrow of the the NCI reasonably said.

But the agency agreed the first two requests were fair. The CAM board grappled for days with how to cooperate with the NIDA without compromising its independence or editorial integrity. Meanwhile, yet more federal agencies offered their two cents’ worth.

“[A press officer with the FDA] contacted me this morning because he has been getting calls from FDA staff, as well as at least one high-profile reporter, asking about NCI’s ‘endorsement of medical marijuana.’ I provided him with the background I had,” wrote Brooke Hardison, NCI media relations analyst. “He needs to provide information for staff at the FDA, and they are trying to figure out how to respond to this issue. I suggested that it might be good for him to have a conversation with those more closely involved in this issue.”

Meanwhile, national attention to the story continued to grow, and NIDA, notoriously anti-pot, was worried about this whole “marijuana treats cancer” thing.

On learning that Ethan Nadelmann, founder and executive director of the Drug Policy Alliance had tweeted about the summary, the NIDA’s Weiss wrote to NCI, “We will be contacting our colleagues at ONDCP [Office of National Drug Control Policy] just to give them a heads up about it.”

Weiss also wrote to her NIDA colleagues, saying “We think that ONDCP needs to be informed.”

The ONDCP, of course, is the office of the Drug Czar. Current czar Gil Kerlikowske, as with all drug czars, is bound by law to oppose marijuana legalization for any purpose, even to save cancer patients.

In any event, the NCI caved to the NIDA’s demands by removing any implied support for prescribing marijuana — noting that the FDA hasn’t approved cannabis as as prescription drug — and, much to the consternation of lead reviewer Abrams, removing a reference to marijuana’s anti-tumor properties.

“You know, the epidemiological data from Kaiser and Tashkin do possibly support an anti-tumor effect in humans,” Abrams wrote. “After reflecting for a few hours, I am not happy that NIDA has been able to impose their agenda on us. The text was vetted by the whole Board. I would ask that we [involve] the whole Editorial Board in the discussion before being bulldogged.

“I am considering resigning from the Board if we allow politics to trump science!” Abrams wrote.

All the relevant CAM board members eventually agreed to the version that went up on March 29 and 30. That last day was when Phil Mocek submitted his FOIA request and is thus the last day that appears in the records given to him.

It is interesting to note that, toward the end of the correspondence record, NCI and NIDA officials were discussing the latter agency providing further information on the supposed “adverse effects of marijuana” so that the CAM Board could “take it into consideration” during its May 6 meeting. Several NCI and CAM members said any “convincing evidence” could result in larger changes to the entry.

NIDA prepared a list of anti-marijuana talking points, including the claim that nine percent of cannabis users “become addicted to the drug” and a completely undocumented claim that marijuana use leads to permanent cognitive impairment, in the hopes of causing just such changes in the NCI’s entry.

But, the Independent reports, May 6 came and went without any additional changes being made to the database.

One can only imagine the kinds of behind-the-scenes wrangling that continues as we speak.

Graphic: NORML Stash Blog

“NCI apparently got a talking to from someone” ~ Radical Russ Belville, NORML. Turns out Radical Russ was right, and NIDA was doing the talking.

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Weed Control

http://www.boston.com/news/globe/ideas/articles/2006/05/28/weed_control/?page=full

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

A greenhouse in the Netherlands, where the cannabis grown for medicinal use is far more potent than that grown legally in the US. (The New York Times Photo)

By Jessica Winter  |  May 28, 2006

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 Multidisciplinary Association for Psychedelic Studies (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.

. . .

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.

. . .

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.

Jessica Winter is a freelance journalist in New York. She writes for The Village Voice, the Guardian (UK), Time Out London, and other publications.

© Copyright 2006 Globe Newspaper Company.