Adequate and Well-Controlled Studies Proving Medical Efficacy of Cannabis Exist but Are Ignored by Marijuana Schedulers

”There are too many lives at stake, not to mention scientific integrity and a burgeoning field of medical discovery requiring much freer access to the marijuana plant.”

From Huffington Post
By Sunil Aggarwal, M.D., Ph.D. and Amanda Reiman, Ph.D., M.S.W.

After a 40-year battle over the placement of marijuana in Schedule I, the U.S. Court of Appeals, DC Circuit, ruled in January on the most recent petition to reschedule marijuana in the case of AMERICANS FOR SAFE ACCESS (ASA) v. DRUG ENFORCEMENT ADMINISTRATION (DEA). The court ruled that the DEA had not acted arbitrarily and capriciously when it denied ASA’s petition filed 9 years earlier to remove marijuana from Schedule I. Schedule I drugs have “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use under medical supervision” — a classification that holds marijuana more dangerous than cocaine, morphine, or methamphetamine, all listed in Schedule II with accepted medical uses. The court ruled that the research needed to move marijuana out of Schedule I does not exist. We respectfully beg to differ.

The DEA’s argument, stated in a 2006 report from the US Department of Health and Human Services (HHS), is that there are no “adequate and well-controlled studies” proving marijuana’s efficacy. Though they noted a number of U.S.-based small-to-medium sized randomized, double-blind, placebo-controlled studies of inhaled marijuana for severe pain, spasticity, and wasting syndromes, all showing valid medical benefits, they felt these were not big enough. What DEA wants to see are akin to Phase III clinical trials — large studies, involving hundreds of subjects, comparing marijuana to placebo in a double-blind, randomized fashion for a specific indication — exactly what the Food and Drug Administration (FDA) wants when evaluating interstate drug marketing applications. Here’s the rub: those kinds of studies have been done and are published in the peer-reviewed scientific literature and yet neither the DEA, nor the HHS, nor the Court took notice. Large, multicenter, randomized, double-blind, placebo-controlled studies involving hundreds of patients in America and abroad that are in some cases a year in duration have been published in U.S. National Library of Medicine indexed journals showing that marijuana, orally administered in extract form, can treat intractable pain in cancer and improve mobility and symptom control in multiple sclerosis. What is arbitrary and capricious is federal agencies have chosen to ignore these studies because they have been done mainly in the private pharmaceutical drug development sector where marijuana-infused products are produced, tested, and sometimes strategically renamed. This hide and seek game has resulted in rigorous research having little to no bearing on public scientific understanding of the medical use of marijuana.

In the case of GW Pharma Ltd (GWP) of Wiltshire, England, it is a mouth spray directly extracted with liquid carbon dioxide from the flowers of two strains of marijuana plants grown in UK-licensed company greenhouses from a worldwide marijuana seed collection that resided in the Netherlands until the late 1990s. In the case of the non-profit Institute of Clinical Research (IKR) of Berlin, Germany, it is a capsulated alcohol extract made from marijuana flowers grown in Switzerland and extracted in Germany. Marijuana extracts have been produced for millennia for consumption, and the public has an overriding interest and right to know that these marijuana studies exist and that their results should logically have bearing on how we as a society understand, utilize, value, and ultimately classify marijuana.

dscn2960”What is arbitrary and capricious is that federal agencies have chosen to ignore these studies.”

So why do the feds not include marijuana resin extract studies when weighing marijuana’s evidence base? Sometimes it is as simple as a name game. Congress’s definition of marijuana — unchanged since 1937 — has always included any compound, extract, or manufactured mixture containing a detectable amount of marijuana resin. If marijuana resin has been extracted and dissolved into a solvent or otherwise concentrated, that new substance is still called marijuana, hash, or hash oil, and this form of marijuana often carries stricter penalties, such as the life sentence penalty recently adopted by Oklahoma in 2011 for first-offense hash production. Millions have been punished under this full definition of marijuana via their possession or distribution of marijuana-infused edibles such as brownies or hash oil. Marijuana medicines made by GWP and IKR are concentrated forms of the marijuana plant with marijuana resin as a base. GWP’s lead product, imported for U.S. trials under DEA license, was named “nabiximols” (Sativex®) and not marijuana by the United States Adopted Names Council, a body composed of organized medicine and pharmacy with FDA backing. In IKR’s case, the company chose the name Cannador® for their marijuana extract seemingly without any regulatory oversight.

Cannabis, marijuana’s proper name, is a commonwealth medicinal plant belonging to no government or private entity. Licensed producers of marijuana extracts in the private sector have a rare and coveted wide latitude of scientific freedom to explore and discover, in a rigorous way, many of the medicinal benefits inherent to cannabis. Does the government have the right to ignore rigorous peer-reviewed published evidence about marijuana’s medical utility accumulated in the pharmaceutical sector which enjoys privileged access to marijuana for research and development? Does private industry have the right to demand, as GWP once did, that marijuana not be rescheduled based in part on their collected data, which they recently achieved in the UK, presumably to protect company market share and pricing by avoiding competition from future marijuana producers who would be empowered by a rational reclassification of marijuana in federal law? Cannabis should not be cordoned off for the sake of private patents, monopolies, or FDA drug marketing applications.

In the U.S., federal agencies have set-up onerous roadblocks that limit researchers’ abilities to access marijuana — the very impetus for private marijuana research to get started overseas, licensed by friendlier governments. A DEA judge actually ruled that the U.S. marijuana supply monopoly was not in the public interest in 2007, but this decision has been ignored. Many major medical societies want marijuana rescheduled or are urging a scheduling review be undertaken, including the American Medical Association, the American College of Physicians, and the Massachusetts Medical Society, publishers of the New England Journal of Medicine. In fact, there has been ongoing resistance to marijuana’s placement in Schedule I ever since Congress first attempted it in 1970. When drafting the law, Congress sought input from Dr. Roger Egeberg, Assistant Secretary of Health at HHS and former personal physician to General MacArthur. He testified that “our recommendation is that marihuana be retained within schedule I at least until the completion of certain studies now underway to resolve the issue”, referring to the comprehensive “National Commission on Marihuana and Drug Abuse” study being undertaken at that time. His recommendations were echoed in a Congressional Committee report which stated “the recommendations of this Commission” would be “of aid” in determining “the appropriate location of marihuana within the schedules of the bill.” When the Commission reported in 1972 that the public threat of marijuana had been greatly exaggerated and recommended that its classification be lowered so that it was no longer on par with heroin, no one took responsibility and marijuana was left in Schedule I. Immediately afterwards, citizens filed the first of several petitions to reschedule marijuana. After 16 years, the first petition was favorably viewed by a DEA judge who concluded after an extensive, two-year evidentiary hearing, that “marijuana, in its natural form, is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within a supervised routine of medical care.” He ruled that marijuana be rescheduled to Schedule II, with painkillers and anesthetics, and that to not do so would be “unreasonable, arbitrary, and capricious.” His decision was overruled by the politically appointed DEA head who said that data were inadequate.

Forty years later, the ASA v. DEA case, now on appeal, is the latest major legal challenge to marijuana’s schedule I status, and new rescheduling bills have been filed in Congress. We cannot let the federal government play fast-and-loose with science on marijuana research any longer–cannabis in all forms must be down-scheduled and de-scheduled. The public health justice imperative to stop curtailment of scientific inquiry and free medical professionals to explore alternative treatments like marijuana with patients is paramount. There are too many lives at stake, not to mention scientific integrity and a burgeoning field of medical discovery requiring much freer access to the marijuana plant.
Sunil Aggarwal, M.D., Ph.D. and Amanda Reiman, Ph.D., M.S.W.

Dr. Aggarwal is a board member of Americans for Safe Access Foundation and a resident physician at a large academic medical center in New York City. Dr. Reiman is a California policy manager for the Drug Policy Alliance and a Lecturer in the School of Social Welfare at the University of California, Berkeley.


Comment from the HuffPost article by Carol Olsen

ASA’s petitions for rehearing and for rehearing en banc were denied by the U.S. Court of Appeals yesterday, so it looks like ASA will be heading to the U.S. Supreme Court with this case. What bewilders me is that you have 18 states that have accepted the medical use of marijuana in treatment of various conditions, and yet the federal government classifies marijuana as a substance with no accepted medical use in treatment in the United States. Where are the state attorney generals to protect the will of the people who voted for this? Why aren’t they filing supporting amicus curiae briefs? Why aren’t the people in those states demanding state representation in this federal rescheduling case?

Comment from Poet Peter

An excellent analysis of the widespread fraud and deception on medicinal cannabis promoted by the US and UK governments. The scandalous and dishonest re-scheduling of Sativex here amounts to corruption by our most senior government ministers and civil servants and will shortly be challenged in the High Court.

See here for the full story of how the UK government has allowed GW Pharma to operate under an unlawful licence for 10 years, is promoting an unlawful monopoly and, most important of all, is maintaining a cruel and harmful policy damaging those who need cannabis as medicine.

10 thoughts on “Adequate and Well-Controlled Studies Proving Medical Efficacy of Cannabis Exist but Are Ignored by Marijuana Schedulers

  1. I hate to call this a conspiracy, but how else can it be explained? I’ll say it again, it’s all about the money. We need to take control of our government once again. It’s become a huge self serving monopolistic corporation.

    Liked by 2 people

  2. Who benefits from the illegal status of this plant? Pharmaceutical companies, textile manufacturers, gangs/cartels/black markets, political parties that receive funding from any of the aforementioned, the list goes on.

    Who is protected by the illegal status of this plant? NOBODY!

    It’s time for the world to wake up.

    Liked by 3 people

  3. People die every single Day due to Cannabis Prohibition.Dying because of to many opioids, Painkillers being used. People are withhold from their ability to have decent lifequality. Medicine that may have the possibility to Cure Cancer and many other diseases have been delayed for Decades. Those whole lies about Cannabis are either 99% Stupid or have economic interests in Prohibition. 7 Billion $ reason why Medicalindustri doen’t want Canabis to replace Painkilllers. And probably 100 Billion $ reason not to make other Medicines for those more than 20 diseases where Cannabis have been proven to help. Oilcompanies. Petrol and Gazoline can be made from Cannabis. Steel, cars can be made form Cannabis. 25.000 Products can be made from Cannabis. Nixon was a Crook. We know that. But why shall we still suffer from the Crookiest thing he ever done? It is not just an US thing its a matter of life or dead for the whole world. Free Cannabis, Kill the Crook Laws. Love KeldKrist

    Liked by 1 person

  4. Clinical drug trial in France sends 6 to hospital in ‘serious accident’
    Rare for volunteers to fall seriously ill when testing new [marijuana synthetic] drug
    The Associated Press Posted: Jan 15, 2016 9:44 AM ET Last Updated: Jan 15, 2016 10:29 PM ET
    Six people are in serious condition at CHU de Rennes hospital, in Rennes, France, after taking part in an early-stage clinical medical trial for an unnamed European laboratory.
    Six people are in serious condition at CHU de Rennes hospital, in Rennes, France, after taking part in an early-stage clinical medical trial for an unnamed European laboratory. (Stephane Mahe/Reuters)
    The long road to drug approval

    One man is brain dead and three others are facing possible permanent brain damage after volunteering to take part in a drug test in western France, the French Health Ministry said Friday.

    The prosecutor’s office has opened an investigation into what French Health Minister Marisol Touraine called “an accident of exceptional gravity” at the private Biotrial clinical lab in Rennes.

    The drug trial, which was testing a new painkiller compound, involved 90 healthy volunteers who were given the experimental drug in varying doses beginning on Jan. 7, she told reporters Friday at a news conference in Rennes.

    Six male volunteers between 28 and 49 years old have since been hospitalized, including one man now classified as brain dead, she said.

    “A serious accident took place,” the minister said earlier in a statement.

    The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said in addition to the brain-dead volunteer, three others could have “irreversible” brain damage. A fifth man is suffering from neurological problems and a sixth volunteer is being kept in the hospital but is in a less critical condition, he said.

    Edan said there’s no known treatment for the experimental drug that Biotrial was testing. The drug was based on a natural brain compound similar to the active ingredient in marijuana.

    Touraine said the medication was not based on cannabis. Earlier Friday, a report from Reuters cited a person familiar with the situation as saying the drug was a cannabis-based painkiller.

    The brain has a system of enzymes and molecules that respond to both plant-based cannabis compounds and ones we produce naturally.

    “The aim with this synthetic approach is to mimic a cannabis-like effect, not by administering a cannabis drug, but by blocking a naturally occurring enzyme,” said Dr. Mark Ware of Montreal’s McGill University Health Centre, who researches the medical use of cannabis.

    “My initial reading of this means it shouldn’t interfere with work on the plant cannabis or plant cannibinoids. It does raise important questions about the role of that specific enzyme, and why blocking it has this devastating result, if this is what was responsible. The scientific community will be watching this story very closely.”

    Touraine urged calm, saying that no drug currently on the market was implicated in the failed trial. She said the drug was produced by the Portuguese pharmaceutical company Bial.

    On a statement on its website, Bial called the drug an experimental molecule in the field of pain. The company said the new drug had already been administered to 108 people without any moderate or serious adverse reactions.

    All the other 83 volunteers are being contacted, Touraine said.

    It’s rare for volunteers to fall seriously ill when testing new drugs. Researchers generally start with the lowest possible dose for humans after extensive drug tests in animals. The French ministry statement said those who had fallen ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers.

    There was ‘an accident of exceptional gravity’ at the private Biotrial clinical lab in Rennes, France, the health minister says. (Damien Meyer/AFP/Getty )

    Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities.” In France, adults volunteering for Biotrial tests can earn between 100 euros and 4,500 euros ($110 US to $4,922 US).

    There have been very few instances worldwide of trials going wrong, said pharmacy and medicine professor Jack Uetrecht of the University of Toronto.

    “I would say it’s probably safer to be part of a phase 1 trial than to take a prescribed drug,” Uetrecht said, because they start with a low dose and monitor so carefully.

    Uetrecht recalls only two disasters in thousands of phase 1 clinical trials.

    Decades ago, a hepatitis B drug caused liver failure, a delayed response that wasn’t picked up in pre-clinical studies on typical animal models.

    The other was in 2006 in Britain.

    Six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system. That prompted a review of procedures and resulted in the U.K. regulatory agency imposing new testing standards.

    Regulations for clinical trials are largely the same in Europe and Canada, Uetrecht said.​

    With files from CBC’s Vik Adhopia, Amina Zafar and Reuters


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