University of New Mexico
The use of medical marijuana for millions of patients suffering from a
wide range of health conditions and the subsequent therapeutic benefits
has long been documented. Twenty-three states, the District of
Columbia, Puerto Rico, and Guam, have determined that Cannabis sativa
(a.k.a. marijuana) can benefit patients suffering from a wide range of
conditions, including cancer, epilepsy, chronic pain, and post-traumatic
stress disorder.
So given all the health benefits for people experiencing debilitating
health issues, why does the federal government continue to stifle
valid, externally valid scientific research on Cannabis sativa?
In a recent paper published in Science, researchers at The University
of New Mexico including Associate Professor Jacob Vigil in the
Department of Psychology and Assistant Professor Sarah Stith in the
Department of Economics, concluded that the federal government continues
to make it extremely difficult to conduct any meaningful research on
the risks and benefits of medicinal use of Cannabis sativa.
"Millions of patients have been granted the authorization to use
medical Cannabis and Cannabis-based products by their respective state
Health Departments and four states have begun taxing and regulating
Cannabis sold for 'recreational' purposes," said Vigil and Stith.
"However, the federal government continues to categorize Cannabis sativa
as a Schedule I drug under the Controlled Substances Act, a more
restrictive categorization than that used for cocaine, methamphetamine
and PCP."
The definition of a Schedule I drug includes a "high potential for
abuse," and "no currently accepted medical use," implying "a lack of
accepted safety use of the drug or other substance under medical
supervision, according to Vigil and Stith.
National Institute on Drug Abuse control
The National Institute on Drug Abuse (NIDA) controls the supply of
Cannabis sativa to researchers. The active agent in Cannabis,
Tetrahydrocannabinol or THC, has potency levels in the products that
NIDA supplies that fall far below those of medical Cannabis sativa
regularly sold and used in the U.S., significantly limiting the external
validity of most clinical research designed to study the effects of
Cannabis sativa on health, both positive and negative.
"This has created a truly unique and an unnecessary paradox in modern
medicine, in which physicians are authorizing treatments to patients,
and patients are regularly using medication without a scientific basis
of knowledge on patient outcomes, forced rather to rely only on
scientifically invalid or anecdotal information," Vigil and Stith said.
Apart from following internal human subject protection procedures,
such as Institutional Review Board (IRB) approval, a scientist designing
a clinical trial on the effects of Cannabis sativa using human subjects
must conduct several independent and lengthy procedures that include
filing for an Investigational New Drug (IND) with the Food and Drug
Administration (FDA), registering the study and obtaining approval from
the Drug Enforcement Agency (DEA), and purchasing the Cannabis sativa to
be used in the study through NIDA.
"An IND requires a level of specificity that may be difficult to
achieve with a plant product or even undesirable when one takes into
account the variation of natural phenotypes and the range of products
used by patients, Vigil and Stith said. "In the case of new drug
development with the intent to commercialize, such oversight may be
prudent, but it is unclear why a study on, for example, the effects of
smoked Cannabis sativa on driving impairment would also require an IND
after receiving approval by a qualified Institutional Review Board."
DEA approval
After filing for and receiving IND approval from the FDA, the
scientist must also register the study and receive approval from the
DEA, an organization tasked with the conflicting interest of "enforcing
controlled substances laws and regulations," which currently prohibit
possession or distribution of Cannabis sativa, obvious components of any
clinical investigation.
The only exception is for Cannabis sativa
purchased through NIDA. In other words, all Cannabis sativa used for
research purposes must be purchased through NIDA, despite the fact that
NIDA's stated mission is to bring "the power of science to bear on drug
abuse and addiction." No mention is made of research related to
therapeutic benefits or the potential for non-addictive recreational
use.
Despite
petitions from other universities, the NIDA Cannabis sativa supply is
grown exclusively at the University of Mississippi since the passage of
the Controlled Substances Act in 1970. It is not uncommon for
researchers to invest several years navigating this system only to
receive a rejection from one of the controlling federal entities, and
typically the DEA, which carries a notorious record of stalling,
impeding, or otherwise obstructing sound medical Cannabis research,
according to the U.S. Drug Policy Alliance (Drug Policy Alliance,
accessed January, 2016).
Potency issues
Another issue with what little research the U.S. government has
approved is the limited potency of the Cannabis sativa products
available through the University of Mississippi. Reliance on this single
source completely restricts researchers from conducting clinical trials
using products that match the potency levels of products used in vivo,
i.e., studies that would enable scientists to assess the therapeutic
benefits and negative side effects of the medicinal Cannabis sativa
actually used by tens of millions of people in the U.S.
The highest level of THC currently available through NIDA is 12.4
percent (National Institute on Drug Abuse, accessed January 2016). As of
December, 2015, out of all the currently funded NIH grants with the
term 'Marijuana' (n = 51) or 'Cannabis' (n = 50) in the Project title,
nearly every study addressed Cannabis use as a problem behavior, and
only two studies measured the (analgesic) effects of Cannabis sativa in
real time, each using products with potency levels between 3.5 percent
and 7 percent THC.
In contrast, a study presented by the owner of a
state-certified Cannabis sativa testing laboratory at the 249th National
Meeting and Exposition of the American Chemical Society found that the
Cannabis sativa sold in Colorado averaged 18.7 percent THC levels with
some strains registering as high as 35 percent THC.
In addition to dosing directly with the plant product, a variety of
concentrates have been developed for vaporizing or ingesting edibles,
both arguably healthier options than smoking. In New Mexico, the
Department of Health has presently capped the THC potency levels in such
products at 70 percent (a level that was widely protested as to low by
visibly ill patients that attended a recent public medical advisory
board hearing).
"Clearly, results from studies using Cannabis sativa obtained from
the University of Mississippi offer little to no insight into the
effects actually experienced by medical marijuana patients in terms of
both therapeutic benefits and negative side effects, if any," Vigil and
Stith said.
What physicians think
A recent poll conducted by the New England Journal of Medicine showed
the vast majority of physicians in the U.S. believe that medical
Cannabis is a safe and effective pharmacological agent for certain
mental and physical health conditions (Adler & Colbert, 2013).
"With increasing morbidity rates associated with prescribed narcotic
abuse (particularly among non-Hispanic Whites) there is a legitimate
place for Cannabis sativa as an alternative and perhaps primary
therapeutic option for patients with a broad range and severity of
negative health symptoms," Vigil and Stith said.
The substitutability of Cannabis sativa for alcohol might also reduce
the exorbitant number of deaths and costs associated with alcohol abuse
and drunk driving.
"Unfortunately, both the costs and benefits of medicinal use of
Cannabis sativa remain essentially unknown, and because the federal
government effectively bans clinical research on Cannabis sativa,
citizens, including many severely ill individuals, may suffer and die
unnecessarily from both the unknown risks and the unknown benefits of
consuming Cannabis sativa," Vigil and Stith added.
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