[THS] US Government Institution Acknowledges Medicinal Uses of Cannabis

[The Harder Stuff in news and commentary]

http://cms.herbalgram.org/heg/volume8/05May/NCI_CannabisPage.html?t=1304368249

HerbalEGram: Volume 8, Number 5, May 2011
US Government Institution Acknowledges Medicinal Uses of Cannabis

On March 17, 2011, the National Cancer Institute (NCI) added information to its
website on the medicinal uses of cannabis (Cannabis sativa) in cancer
treatment—marking the first time a US government agency has acknowledged the
herb’s therapeutic benefits.1*

Many organizations, media outlets, and individuals around the country are referring
to this development as a groundbreaking event. “It adds to the growing scientific
consensus around the medical efficacy of cannabis and firmly establishes the plant as
a [complementary and alternative medicine] treatment alternative,” said Kris Hermes,
media specialist for Americans for Safe Access (ASA), an organization promoting safe
and legal access to cannabis for medicine and research (e-mail, April 11, 2011).
“And, it further contradicts the federal government's position, and that of the
Department of Health and Human Services (HHS)—which oversees [the National
Institutes of Health] and NCI—in particular, that cannabis ‘has no currently accepted
medical use in treatment in the United States.’”

The review summary, titled “Cannabis and Cannabinoids,” is located on NCI’s website
under the main section “Cancer Topics,” and under subsequent subsections
“Complementary and Alternative Medicine,” “Pharmacologic and Biologic
Treatments,” and, lastly, “Complex Natural Products.” It includes a general overview
of research supporting cannabis’s use in cancer treatment, as well as its mechanisms
of action. Additionally, it includes sections on cannabis’s and cannabinoids’ history;
laboratory, animal, and preclinical studies; human clinical studies; and overall level of
evidence. The review features strong language, such as “Cannabis has been used for
medicinal purposes for thousands of years prior to its current status as an illegal
substance,”2 and, “The potential benefits of medicinal Cannabis for people living with
cancer include antiemetic effects, appetite stimulation, pain relief, and improved
sleep.”3

“Overall, I'm impressed favorably with the breadth, scope, and details of the
summary,” said Dennis McKenna, PhD, a senior lecturer and research associate at
the University of Minnesota’s Center for Spirituality & Healing. Dr. McKenna is an
ethnobotanist who has extensive research expertise on psychoactive medicinal plants.
“Considering this is the NCI, and that the [US Food and Drug Administration]’s official
position is that cannabis has no medical use, this is a remarkably honest and
objective assessment.”


Impact on Cannabis’ Schedule I Status

Despite the relatively quiet manner in which NCI implemented its new cannabis page,
the addition has spurred much discussion over its impact on the movement to have
cannabis rescheduled. Cannabis is currently listed by the US Drug Enforcement
Agency (DEA) as a Schedule I drug, a classification that prohibits cannabis use for
anything other than research. Cannabis shares this status with drugs like heroin and
LSD. According to the Controlled Substances Act, Schedule I drugs meet 3 criteria:
(1): having a high potential for abuse; (2) having no currently accepted medical use
in treatment in the United States; and (3) having a lack of accepted safety for use of
the drug or other substance under medical supervision.4 Some say that NCI’s
addition of information on cannabis’s medicinal uses in cancer treatment to its
website further challenges the validity of this Schedule I status, particularly in regards
to the second criterion.5

The rescheduling movement aims to have cannabis downgraded to a Schedule III or
lower classification. Schedule III drugs are considered to have a less significant
potential for abuse than Schedule I and II drugs, as well as a currently accepted
medical use in treatment in the United States.4 They are available through
prescriptions, are permitted to have 5 refills in 6 months, and may be ordered orally.6
Dronabinol (brand name Marinol®), a synthetic drug containing
tetrahydrocannabinols (THC), is currently a Schedule III drug. A federal petition to
reschedule cannabis, which was filed in 2002 by the multi-organizational Coalition for
Rescheduling Cannabis, has gone unanswered by the US government for almost 10
years.7

Dr. McKenna said he thinks the NCI review will probably, and “unfortunately,” have
very little impact on the scheduling of cannabis. “These decisions are made by
politicians, who as a rule are not scientists or clinicians and are quite happy to ignore
scientific evidence when it's inconvenient,” he said, noting mounting scientific
concerns about climate change as an example. “Only when this information becomes
widespread enough in the public domain, and is understood by sufficient numbers of
people, who then demand changes in the scheduling, will this information make a
difference. What will or may also make a difference is when a politician, or a close
relative of one, receives significant benefits from cannabis as an adjunct treatment in
cancer therapy. Then, and only then, will you see a change.”


NCI’s Reaction

Addressing its role in the cannabis scheduling debate, NCI added information to the
cannabis page, after its initial posting, stating that PDQ, which authored the review,
“is editorially independent of the National NCI.”8 NCI wrote, “The summary on
Cannabis and cannabinoids does not represent a policy statement of NCI or NIH. The
summary statement represents an independent review of the literature; that review is
not influenced by NCI or any other federal agency.”

PDQ, or Physician Data Query, serves as NCI’s cancer database of information on
cancer topics, international cancer clinical trials, a directory of cancer physicians, and
cancer term and drug dictionaries.9 Several PDQ editorial boards regularly review
new cancer-related research and information in consideration for adding to NCI’s
website. The Complementary and Alternative Medicine (CAM) editorial board of PDQ,
which authored the NCI cannabis page, includes representatives of the cancer
patient community and a variety of CAM and oncology experts.

“PDQ Editorial Boards summaries do not generate official NCI recommendations or
establish official NCI stances on any issue,” said Jeffrey White, MD, the editor-in-chief
of the PDQ CAM board. “Each PDQ Board is responsible for identifying the summary
topics, writing, revising, and updating the summaries for which it is responsible. The
NCI only establishes and financially and administratively supports the PDQ Editorial
Boards. Therefore the posting of the PDQ Summary on Cannabis and Cannabinoids
does not signal any official NCI opinion on this topic” (e-mail, April 29, 2011).

However, possibly compromising NCI’s statement on the unquestionable, clear
separation between NCI and PDQ, Dr. White also serves as NCI’s director of the
Office of Cancer Complementary and Alternative Medicine.

“Saying that NCI didn't say this, [that] PDQ said it, is a bit disingenuous,” said Dr.
McKenna. “[NCI] contracted the study and paid for it. It went through several levels
of peer review by qualified experts; they put it on their website. That's a sign that
they believe the information is accurate, at least enough to put [it] out to clinicians
and others.”

In trying to illustrate further why the new cannabis review does not signify a federal
agency recognizing an accepted medical use of cannabis, Dr. White pointed out,
“The summary states, ‘At present, there is insufficient evidence to recommend
inhaling [smoked] Cannabis as a treatment for cancer-related symptoms or cancer
treatment–related side effects outside the context of well-designed clinical trials.’
Thus, the PDQ Editorial Board has not made a statement endorsing the use of
cannabis in the management of cancer patients.”

(For a discussion on the US government’s alleged suppression of clinical cannabis
research, please see this article published in HerbalGram issue 85.)

Due to media and governmental attention, NCI changed some sections of the review
about 2 weeks after its initial posting. In a note explaining these changes, NCI wrote:
“Reviewers for the summary on the PDQ CAM Editorial Board
 decided to change
the wording, in order to clarify the meaning that the Board originally intended to
convey and to correct several possible misinterpretations.”8

The changes, most of which can be considered relatively minor, consisted of
clarifying that cannabis is not approved by the FDA for any medicinal use; that
physicians appear to prescribe cannabis mostly for symptom management (in order
to avoid the impression that it recommends the prescribing of cannabis by
physicians); deleting mention of cannabis’s potential anti-tumor properties from the
general information section; and clarifying that “even abrupt cessation of
cannabinoid intake is not associated with rapid declines in plasma concentrations that
would precipitate severe or abrupt withdrawal symptoms or drug cravings.”7

According to Dr. White, these changes were decided upon after the institute’s Office
of Communications noticed that various media outlets were “focusing on and
misinterpreting” the following sentence: “In the practice of integrative oncology, the
health care provider may recommend medicinal Cannabis not only for symptom
management but also for its possible direct antitumor effect.”

“The sentence was being interpreted as NCI’s official support for the use of cannabis
for the treatment of patients with cancer,” said Dr. White. “This is partly because
frequently PDQ summaries are misunderstood to be official NCI statements though
they are not. However, it was also clear that the intent of the sentence was being
misconstrued. It was in the general information section and was only intended to be
a factual statement about what is happening in medical practice, at least where
marijuana use can be legally recommended according to state or local law.  It was
never intended to be a statement about the appropriateness of such
recommendations.”

NCI also received a message from the National Institute on Drug Abuse (NIDA)
expressing some concerns with the same sentence. “The note from NIDA along with
the other media statements were shown to me and I discussed them with Dr. Donald
Abrams, who is the lead reviewer for the summary,” said Dr. White. “I recommended
changing the sentence to the current wording because I thought it was likely to be
the most accurate and supportable statement that could be made about why
cannabis was being recommended by healthcare practitioners. We agreed on this
wording and the changes were made.”


Possible Shortcomings of the Review

Though deleted from the general information section, data on cannabis’s anti-tumor
effects still exist in the review’s section titled “Laboratory/Animal/Preclinical
Studies.”10 This information covers several published studies on anti-tumor effects,
but it omits what some might consider evidence that is just as—if not
more—compelling. A 2006 study published in The Journal Of Pharmacology And
Experimental Therapeutics, for example, showed that cannabidiol (CBD) was the
“most potent inhibitor of cancer cell growth” in mice injected with human breast
carcinoma cells” (compared with cannabigerol, cannabichromene, cannabidiol acid
and THC acid).11

Additionally, in a 2006 study, Spanish researchers conducted a pilot phase I clinical
trial on 9 patients with recurrent glioblastoma multiforme. After being administered
THC, two patients experienced “inhibited tumor cell proliferation” and “decreased
tumor cell Ki67 immunostaining.”12 Furthermore, a January 2011 study in Molecular
Cancer Therapeutics—published 3 months before the NCI cannabis review was
posted—found that THC, CBD, and temozolomide exerted “strong antitumoral action”
in cultures of human glioma cells.13 Also of interest yet excluded by the NCI review,
an in vitro study conducted in 2010 by researchers in California reported that CBD
“inhibits human breast cancer cell proliferation and invasion,” and “significantly
reduces primary tumor mass as well as the size and number of lung metastatic foci in
two models of metastasis.”14


Inability to Maintain Position Against Science

According to Hermes of ASA, the medical cannabis access organization, the NCI
cannabis review does not necessarily indicate a broader shift by larger US
governmental entities, such as HHS. Instead, he said, it might signal a more general
inability of the federal government to maintain its long-held position against public
opinion and science.

“Certain agencies are reviewing their policies and changing them slightly enough to
give the impression of meaningful change,” he said, noting the US Department of
Veterans Affairs’ July 2010 decision to allow patients to use cannabis as prescribed by
outside physicians without risking denial of VA services and benefits.15 “These policy
changes are by no means comprehensive or adequate to solving this public health
issue at the federal level, but it indicates that pressure on the government is
working.”

Dr. McKenna also pointed out the problematic position of the US government. “The
fact that there are FDA approved medicines for treating symptoms associated with
cancer [like] nausea (e.g., Dronabinol) means that they must believe [cannabis], at
least in that form, has some evidence for therapeutic use; yet the official position is
that cannabis and cannabinoids have no medical uses. It's not a consistent position;
it does not make scientific sense.”

Though the recent website addition by NCI offers a glimmer of hope for medicinal
marijuana patients, researchers, and advocates, the administration of President
Obama is not acting as many had hoped. ASA recently gave Obama a “failing grade
for his record on marijuana,” citing, among other examples, federal “SWAT-style”
raids on medical marijuana dispensaries despite announcing that the administration
would decrease focus of federal enforcement in states that have legalized medical
marijuana.16 Steph Sherer, executive director of ASA, said in a press release, "It is
not acceptable to hold millions of sick Americans hostage to a political double
standard. It's time for the Obama Administration to recognize the science, act with
integrity, and reschedule marijuana.”7


*Both the Institute of Medicine (IOM) and a panel of experts convened by the US
National Institutes of Health (NIH) have previously recognized that cannabis can be
medicinally beneficial to some patients.17 But the IOM is “an independent, nonprofit
organization that works outside of government to provide unbiased and authoritative
advice to decision makers and the public.”18 Additionally, NIH expert panels are
independent bodies and usually consist of both governmental and non-governmental
scientists who are called upon to make recommendations to policy makers. Neither of
these entities are official bodies of the federal government.


—Lindsay Stafford


References

1. Daly K. Federal agency proclaims medical use for marijuana. The American
Independent News Network. March 24, 2011. Available at:
www.americanindependent.com/175499/federal-agency-proclaims-medical-use-for-
marijuana. Accessed April 10, 2011.

2. Cannabis and Cannabinoids (PDQ): Overview. National Cancer Institute website.
Available at:
www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page1. Accessed
April 17, 2011.

3. Cannabis and Cannabinoids (PDQ®): General Information. National Cancer
Institute website. Available at:
www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page2.
Accessed April 26, 2011.

4. US Drug Enforcement Administration. The Controlled Substances Act. January 22,
2002. Available at: www.justice.gov/dea/pubs/csa/823.htm#f.

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http://washingtonindependent.com/106943/federal-agency-proclaims-medical-use-
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6. Commonly Abused Drugs. National Institute of Drug Abuse website. Available at:
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7. Federal agency recognizes marijuana's medical benefit for people living with
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Available at: www.safeaccessnow.org/article.php?id=6338.

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April 26, 2011.

9. PDQ®. National Cancer Institute website. Available at:
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April 26, 2011.

11. Ligresti A, Moriello AS, Starowicz K, Matias I, Pisanti S, et al. Antitumor activity of
plant cannabinoids with emphasis on the effect of cannabidiol on human breast
carcinoma. The Journal Of Pharmacology And Experimental Therapeutics. 2006.
318(3);1375-1387.

12. Guzmán M, Duarte MJ, Blázquez C, Ravina J, Rosa MC, et al. A pilot clinical study
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Journal of Cancer. 2006:95;197–203.

13. Torres S, LorenteM, Rodríguez-Fornes F, Hernandez-Tiedra S, Salazar M, et al.
Combined preclinical therapy of cannabinoids and temozolomide against glioma. Mol
Cancer Ther; 10(1) January 2011

14. McAllister SD, Murase R, Christian RT, Lau D, Zielinski AJ, et al. Pathways
mediating the effects of cannabidiol on the reduction of breast cancer cell
proliferation, invasion, and metastasis. Breast Cancer Res Treat. DOI
10.1007/s10549-010-1177-4.

15. Yen H. Medicinal marijuana in VA clinics OK’d in states where it’s legal. Huffington
Post: Politics. July 15, 2010. Available at:
www.huffingtonpost.com/2010/07/27/medical-marijuana-in-va-c_n_660449.html.
Accessed April 17, 2011.

16. Medical Marijuana Report Card Gives Obama Failing Grade for Broken Promises &
Half-Measures [press release]. San Francisco, CA: Americans for Safe Access; April
21, 2011. Available at: www.safeaccessnow.org/article.php?id=6371. Accessed April
27, 2011.

17. Stafford L. The state of clinical cannabis research in the United States.
HerbalGram. 2010;85:64-68. Available at:
http://cms.herbalgram.org/herbalgram/issue85/article3485.html.

18. About the IOM. Institute of Medicine website. Available at: www.iom.edu/About-
IOM.aspx. Accessed April 10, 2011.