Big Pharma Gets Green Light

Big Pharma Marijuana Cannabis Now

Guess who benefits when Uncle Sam opens the research weed supply chain?

Cannabis is still highly dangerous and has no place in modern medicine, according to the U.S. government – who still wants a bigger and better supply of the troubled stuff on hand anyway, just in case.

And Uncle Sam wants you – yes, you – to try and grow some research-grade cannabis for your country. But good luck with that. It won’t be easy.

This past summer, after several unexplained delays, fueling unfounded rumors that the Obama Administration would legalize marijuana of its own volition, the Drug Enforcement Administration announced on Aug. 12 that it would not be removing marijuana from Schedule I of the Controlled Substances Act.

Despite a growing body of knowledge in other countries and a majority of American states with some kind of medical marijuana program, the decision to leave marijuana in the Schedule I designation means pot is still officially as dangerous as heroin and LSD. Cocaine and methamphetamine (both Schedule II) are officially safer and more beneficial.

The reasons why, given by Acting DEA Administrator Chuck Rosenberg, is a continuation of the circular logic that’s fueled the U.S. war on weed for more than four decades. And the DEA’s own language now seems to suggest that Big Pharma – not the cannabis industry – will have the inside track to a better supply.

“There is growing public interest in exploring the possibility that marijuana or its chemical constituents may be used as potential treatments for certain medical conditions,” Rosenberg wrote in a letter published in the Federal Register on Aug. 12. “One of the ways DEA can help to facilitate research involving marijuana is to take steps to increase the lawful supply of marijuana available to researchers.”

Research Monopoly Ends

Currently, there is a single government-approved marijuana supplier: the University of Mississippi. Holding this monopoly for nearly 50 years, access to its supply is extremely limited, granted only to funded researchers receiving several onerous layers of bureacratic approval.

According to NIDA, just eight shipments of government bud went out to researchers in 2015, with another eight shipments in 2016 as of late August.

But this federal marijuana supply chain is set to expand. The DEA now says it will consider applications from commercial enterprises as well as from research universities – which thrilled some researchers.

“It’s a complete and total end of the NIDA monopoly,” said Dr. Sue Sisley, whose DEA and NIDA-approved study into whether smoked cannabis helps combat veterans with PTSD is scheduled to begin this fall.

“This new policy permits commercial growing operations to be approved with the purpose of producing a product that can be used in research and also for potential commercial sales,” she said. “The federal monopoly on the production of marijuana for federally-regulated research, in existence since 1968, is now over.”

Despite this, a DEA spokesperson contacted by Cannabis Now said no applications had yet been received by the end of August.

 Photo Gracie Malley for Cannabis Now

Government-Grade Ganja

Ole Miss grows a single strain, its terpene content unknown, available in either bulk at $2,497 a kilogram or $14 per joint in one of 13 strengths – low, medium, high, or very high THC or cannabidiol (CBD); placebo, or a combination.

And “very high” THC and CBD caps out in at 13 percent THC, meaning researchers are forced to give human subjects less than half as strong as cannabis from recreational stores or dispensaries.

This is the marijuana still being supplied every month – mailed out in half-pound tins of prerolls to the surviving patients in the Compassionate Investigational New Drug Program. Started in the 1970s, after a glaucoma sufferer named Robert Randall sued the government and accepted a settlement of free government-supplied weed for life, enrollment in that program capped at 30 people, of whom four are still alive. One, Irvin Rosenfeld has been receiving nine ounces monthly since 1982 for a rare bone disorder; Elvy Musikka, who suffers from glaucoma, began receiving eight ounces monthly in 1988. The program closed to new patients in 1992.

While this weed has kept Rosenfeld and Musikka alive and healthy, researchers have long complained that the hard-to-get supply is also insufficient. Today, there’s an increase in demand for research into extractions high in cannabidiol (CBD) and low in THC – research clamored for even by longstanding drug warriors like U.S. Sen. Dianne Feinstein. High-CBD, low-THC oil has been approved by state governments even in reliably red Republican parts of the country that still have punitive anti-marijuana laws on their books.

“DEA fully supports research [of extracts],” Rosenberg insisted in the Aug. 12 letter. “DEA has concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally authorized marijuana growers.”

But there’s a catch – several of them, really.

Not So Fast

The DEA does not specifiy the number of new applicants allowed or how much they’ll be able to grow. The organization does state suppliers will be “limited” in order to avoid diversion of government-grade weed to the black market. It also outlines that while experienced suppliers will be considered, violations of the Controlled Substances Act, for, say, growing marijuana, may count against them.

The DEA’s language surrounding those who will be accepted for the program highlights an advantage for pharmaceutical companies over cannabis growers striving to work within the system.
“Should… a marijuana-derived drug [be] shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States – independent of the NIDA contract process.”

Meanwhile, other obstacles remain. In the early 2000s, University of Massachusetts professor Lyle Craker received initial approval to grow research cannabis, but never got the chance. His application was personally rejected by then-DEA Administrator Michele Leonhart in 2005. Craker says he plans to apply for federal government approval – but first, he needs the permission of his state government, which has yet to offer a response.

And even if the government adds supply, there’s no guarantee research will be funded or approved.

Research hit a peak – 17 applications in a five-year period after the California Legislature used $9 million to create a medical cannabis research institute in 1999.

Once the state stopped funding the research, the studies stopped.

Sisley’s research is also state-funded, with $2 million from the Colorado Department of Public Health. It’s very unclear if more money will be forthcoming from other sources.
Still, “You’ll agree the handwriting is on the wall…  this product needs to be studied,” Craker says. “We need to be able to supply various strains to medical professionals. We need to test and see if these strains are different than others, we need to look at the terpenoids, not just the stuff that makes you high.”

“The DEA must be recognizing that to some extent that they are losing control.”

Just how much control the DEA will ultimately relinquish, however, remains to be seen.

Originally published in Issue 23 of Cannabis Now. LEARN MORE

Chris Roberts has written about medical cannabis, drug policy, and legalization ever since spending a few months in Humboldt County in 2009, with bylines for the San Francisco Chronicle, San Francisco Examiner, and SF Weekly. Follow him on Twitter and Instagram @cbloggy.

3 Comments

  1. M. Wolf Segal aka The Farmer in the Sky

    January 3, 2017 at 8:36 am

    The following are currently axiomatic:

    1) Cannabis is more therapeutically efficacious when its various chemical constituents are used as part of an ensemble rather than as isolated individual molecules.

    2) The relative levels of cannabinoids, terpenes, flavinoids and thiols present determines how a particular “vintage” of cannabis will affect a particular consumer (medical, social or spiritual.) The percentage, by dry weight of the dose’s mass which is comprised of these active ingredients frequently determines the strength of the dose’s effects. Together, these are what I refer to as Cannabis Chemical Ensembles. (CCEs)

    (With all due respect to Dr.s Mechoulam and Russo “ensemble effect” is a more apt description of what is going on than “entourage effect.”)

    3) There are literally hundreds of thousands of possible CCEs.

    4) There are thousands of medical conditions which CCEs might be helpful in treating.

    5) How a particular “vintage” of cannabis affects a particular patient is a result of the CCE in that vintage interacting with that individual patient’s biochemistry.

    6) Each patient has a different bio-chemistry. (see, “patient individuation”) and they frequently react differently to a given substance.

    7) Different Routes of Administration can alter how a given CCE affects a given patient.

    8) Allopathic medicine will never recognize the therapeutic use of CCEs as valid until we can produce quantifiable doses with repeatable effects.

    The reader might ask, “Where does all this leave those of us who want to explore cannabis’ full potential in medicine and elsewhere?”

    Sadly, the answer is that, at present, most of us are doing the equivalent of standing on the edge of the Grand Canyon on a pitch-black night firing a shotgun down into the canyon in the hope that when we climb down in the morning we will find something to cook for breakfast. More specifically, the majority of recommendations about the therapeutic use of cannabis currently being made are about what “Indica” or “Sativa” do. At a very slightly more advanced level we might hear a particular “strain” mentioned as being effective with a particular condition. These anecdotal reports get gathered into collections. These collections are a step in the right direction and have led to several specific strains being recommended for specific conditions and even a few being looked at for pre-clinical studies.

    However, relying on this approach at the current pace we won’t have a close to complete picture of which CCEs work best in treating what symptoms of which diseases and for which patients, in under 100 years, give or take a decade.

    Making these, already woefully inadequate, efforts at data collection even less meaningful is that there is no guarantee that what one grower is calling, for instance, “White Widow” is actually the same genetically as what another grower is calling “White Widow.” Even if it is, the end product still can be very different chemotypically if : a) the conditions the plant is grown under are different, b) it is harvested at a different stage of maturity or c) it is stored differently.

    What is the solution to this conundrum? Focused research.

    For research to be meaningful the data it’s based on must be valid. So one axiom for any proposed research is that uniform protocols and/or calibrated standards must be used in all testing. There is no legitimate reason, except the current legal status suffered by cannabis, that testing for potency and contaminants is being done by labs which are not ISO-certified. Many ISO certified labs have not been willing to do analytical testing on cannabis because of its status as a Schedule I Controlled Substance.

    It is in the best interests of both those who would seek to regulate cannabis (the FDA/DEA and various state agencies) and those who seek to research its potentials to have uniform, industry-wide testing standards. These standards need to be at least as high as those currently imposed on the nutriceutical/dietary supplement and pharmaceutical industries. To that end a research collaborative is being organized to determine which CCEs might merit further study in treating specific conditions or symptoms. We have begun reaching out to all industry organizations, government agencies concerned with regulating cannabis in the states which have enacted some form of quasi-legalization, currently functioning cannabis testing labs and researchers to facilitate the development and acceptance of uniform testing protocols.

    The particular area where the need for such a collaborative is strongest is gathering the information on which to base future studies of particular CCEs. The FDA/DEA is almost certainly going to impose regulations requiring testing to a stricter standard than most states are currently requiring. Those who don’t conform won’t be able to get the necessary permits to do legal cannabis research.

  2. Lawrence Goodwin

    January 2, 2017 at 8:48 am

    The compassionate souls at #illegallyhealed broke a story right before the November 8 election, titled “Federal Government Exposed: Marijuana Banking Conspiracy Revealed.” The allegations contained in the article, posted anonymously by a writer called 420TruthTeller, stem from the oft-cited patent #6,630,507, “Cannabinoids as Antioxidants and Neuroprotectants.” Upon further investigation, the writer found that the federal government has investment stakes in at least 400 different patents related to natural and synthetic “cannabinoids” used for medical purposes—in brazen collusion with giant U.S. banking, pharmaceutical and other companies named in said patents. Taxpayers funded much of the scientific research that led to the filing of those patents, while simultaneously funding the multi-billion dollar enforcement of federal Schedule I “marihuana” law in all 50 states. It’s solid evidence proving WHY federal law has not changed and who the Drug Enforcement Administration truly works for (hint: it’s not we the average citizens).

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