folder Filed in Policy
To De-schedule or Reschedule Marijuana
Anthony Denicola

At Stony Brook University, Dale Deutsch, a professor of cell biology, keeps his marijuana in a locked refrigerator within a locked room. This has more to do with the strict federal regulations in place for researchers working with marijuana for medical purposes than fear of theft by college stoners. Deutsch says it took nearly a year of frustrating paperwork and formal requests to the Drug Enforcement Agency to acquire the 100 milligrams of marijuana – the size of an average pill capsule – that sits securely in his lab.

Deutsch’s work focuses on cannabinoids – the active chemical compounds in marijuana – and their interactions with cannabinoid receptors in cells.

Deutsch left Stony Brook for a year’s sabbatical in San Francisco in September, and soon after arrival he walked into a marijuana dispensary – as a researcher, not a customer – and was greeted by a galaxy of marijuana infused products. One thing he noticed was an edible product whose potency was listed as 500 mg of tetrahydracannabinol (THC) and 6 mg of cannabidiol (CBD), the principal cannabinoids in marijuana that researchers like Deutsch are studying.

The edible, sold to anyone with a recommendation from a California doctor, had a THC concentration five times that of what he keeps under lock and key in his lab in New York.

“It is ridiculous,” Deutsch said. “I only have 100 milligrams in my lab but in California they are selling 500 milligrams in a cookie.”

As ridiculous as it may seem, for cannabis researchers the frustrations involved with acquiring research marijuana are nothing new. The first clinical research trial for marijuana in the United States, in 1997, was the culmination of a five-year bureaucratic obstacle course, in which the biggest hurdle was the question of where research marijuana was going to come from. The DEA and National Institute of Health (NIH) finally approved the proposal with the stipulation that the researchers used marijuana supplied by the National Institute on Drug Abuse (NIDA). This marked the first non-abuse study for which the federal government provided marijuana.

Though 23 states have legalized medical marijuana and four have legalized recreational use, the divide between federal policy and scientific evidence remains.

Now, nearly 20 years later, though 23 states have legalized medical marijuana and four have legalized recreational use, the divide between federal policy and scientific evidence remains a chasm and a woeful gap in knowledge.

Despite the move toward liberalization by states, marijuana remains a Schedule 1 drug under the Controlled Substances Act of 1970—a category that defines it as having “no currently accepted medical use.” That distinction – or scheduling – has been blamed for a myriad of problems facing both the medical and recreational branches of the budding marijuana industry.

Because of IRS tax codes that do not allow businesses whose product is a schedule I drug to use banking services, dispensaries in Colorado, Oregon, Alaska and Washington have been forced into running dangerous, all-cash operations. They also have to pay taxes on their gross revenue – before expenses – unlike every other business in this country that pays taxes on their net profits.

Another problem is the tremendous burden on the criminal justice system, which, according to FBI records, dealt with 700,993 arrests for marijuana in 2014 – about one every 45 seconds. 88.4 percent of those were for possession alone.

But while these issues have garnered much of the media and political attention, the federal government’s shackling of medical marijuana research may be the bigger problem. This gap in knowledge has created an environment that allows pseudoscience, blind advocacy and political rhetoric to run free while patients suffer, scientists fume and doctors scratch their heads.

While many physicians might be intrigued by marijuana’s medical potential, a shortage of research causes most to remain unconvinced. But ask a researcher for more studies and you will probably get an earful about federal regulations that make acquiring research materials – legally – an arduous, frustrating and ultimately prohibitive process.

New York became the latest state to enact medical marijuana legislation with the passing of the Compassionate Care Act in 2014, albeit with a much stricter model than the other 22 states.

This gap in knowledge has created an environment that allows pseudoscience, blind advocacy and political rhetoric to run free while patients suffer, scientists fume and doctors scratch their heads.

In spite of the strict rules, which were designed to create a more medically viable model, federal scheduling is still putting a damper on expectations leading up to the January opening of dispensaries.

“My biggest concern since January of this year has been that we don’t have any doctors,” said Sen. Diane Savino (D-NY), a sponsor of the Compassionate Care Act. “If you don’t have any doctors then you don’t have any patients, then you don’t have any customers. So what if we grow medical marijuana and nobody comes?”

According to Marijuanadoctors.com, a website that connects patients to doctors who will certify them for medical marijuana, Savino’s concerns are well founded. They conducted a survey earlier this year of 500 NY area doctors to gauge interest in NY’s medical marijuana program but only found one doctor who admitted he was interested.

That is not to say there is only one marijuana-friendly doctor in all of New York, but it is an indication of just how few physicians have been involved up to this point.

Also, as a presidential election year approaches, candidates have begun weighing in on marijuana reform, putting cannabis back in the political limelight.

Both Democratic front-runners, Hillary Clinton and Bernie Sanders, support removing marijuana from the list of schedule I drugs, but with one key distinction. Clinton has voiced support for rescheduling marijuana to a schedule II drug to ease restrictions on research.

“I do support the use of medical marijuana,” she said during the first Democratic debate in October. “And I think even there we need to do a lot more research so that we know exactly how we’re going to help people for whom medical marijuana provides relief.”

Sanders has come out in favor of de-scheduling marijuana and removing it from the Controlled Substances Act entirely, calling the current state of the criminal justice system “absurd.”

Most Republicans support the current scheduling. But a few like Donald Trump, Ted Cruz and Rand Paul have come out in support of states regulating their own marijuana laws without interference from the federal government.

Regardless of whether or not you agree that recreational use for adults should be legal across the country, there is one big question – among others- looming for Congress and the next administration: Should federal marijuana laws be changed to ease restrictions on research and allow for the further development of medical marijuana?

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Federal Scheduling and Research

University campuses – typically bastions of science and research – have largely been absent from the world of medical cannabis. One reason for this, according to a 2013 report published in Nature, is that universities may worry how donors, parents or trustees may react to research programs that promote benefits of a schedule I drug.

Deutsch doesn’t miss the irony. “In order for me to have cannabis here in the lab at Stony Brook, I need the FDA, the DEA – both the federal and the state – to sign off on it,” Deutsch said. “They have all these people controlling our research substances while people are smoking it outside the building.”

The first to actually get marijuana into a research building was Dr. Donald Abrams, an oncologist at the University of California San Francisco Medical Center, and the principal investigator for the first ever clinical trial involving smoked marijuana in the United States in 1997.

“They have all these people controlling our research substances while people are smoking it outside the building.”

Abrams wanted to study the effectiveness of marinol – a synthetic cannabinoid approved by the FDA in 1992 – compared with smoked marijuana in treating HIV-related “wasting,” a condition characterized by significant, rapid weight loss.

Results showed a favorable outcome for smoked marijuana compared to Marinol in his patients, but the obstacles he faced before the study even began would have been prohibitive had he not been determined.
“When politically sensitive research proposals include sound science they can prevail if investigators are willing to persist,” Abrams said in a review of the arduous process published in 1998 in the Journal of Psychoactive Medicine.

And persist they must. Any researcher seeking approval for research with marijuana must go through a multi-agency review process that includes licenses and approvals from the DEA, FDA, NIDA and the states themselves. Researchers must undergo the FDA’s Investigational New Drug (IND) application. Plus, if they want federal funding from the Nation Institutes of Health (NIH), they must also undergo a three-step NIH review. After that, a DEA registration for possessing the substance for research must then be obtained. So far, all of these bureaucratic hoops apply to any schedule I drug.

What makes marijuana different from other schedule I drugs is the difficulty involved in acquiring it. Those wanting to work with marijuana must submit their proposal and a request for research substances to NIDA, which must approve the supply they need.

For marijuana researchers, the drugs they need are at the University of Mississippi, where NIDA has a contract to produce marijuana for all federally approved studies. This is the sole facility licensed by the DEA to produce research cannabis and until 2015, were only permitted to produce 20kg (44lbs) annually, regardless of the quality of the plant.

Quality is important because research materials must meet certain standards depending on the study. As a result, scientists may be forced to wait years for research materials if the available cannabis does not meet their specifications.

As an indication of how difficult it is to acquire NIDA-issued marijuana; since 1990 there have only been 27 clinical trials involving the actual cannabis plant. That is just barely over one study per year for the last 25 years.

Since 1990 there have only been 27 clinical trials involving the actual cannabis plant. That is just barely over one study per year for the last 25 years.

According to a Brookings Institute report published in October “both the DEA-mandated NIDA monopoly on research marijuana and DEA registration represent hurdles to marijuana research that are not present for Schedule II drugs—or even other Schedule I drugs.”

But they are not done yet. Hospitals, pharmacies and physicians can acquire what is called a “Dispensing and Instructing License” – or practitioner’s license – for schedule II –V drugs. It allows a hospital or private practice to conduct clinical trials with these drugs so long as it is in their medical scope and stays in their facility. This license is not available for marijuana because it is a schedule I drug, and therefore has no “accepted medical use.”

The list of Schedule I drugs reads like a who’s who of the most illicit celebrity substances, including LSD, heroin and ecstasy. But there used to be more.

Since 1970, five drugs have been rescheduled from a schedule I to a schedule II or III substance. Of those five, four are opiates and the fifth is Marinol, a synthetic form of dronobinol, a cannabinoid that is predominantly used as an appetite stimulant for cancer and AIDS patients. Among the opiates are two derivative forms of fentanyl, a powerful analgesic, and etorphine, a drug that is used for the immobilization of exotic animals and can be 1,000 to- 3,000 times more potent than morphine.

But how exactly does a drug get rescheduled or de-scheduled?
There are two ways to go about it. The first is simple; Congress can amend the Controlled Substances act and either re-schedule marijuana to a schedule II or III substance, or remove it entirely.

The other way, according to the Brookings Report, is administrative and is a much longer process.

First, an “interested party” files a petition with the attorney general. The attorney general then reviews it and forwards to the Secretary of Health and Human Services (HHS) with a request for scientific and medical evaluation.

During this evaluation – typically delegated to the FDA – the available scientific evidence is reviewed to determine the efficacy of the drug as well as the potential for abuse or harm to public safety.

Since 1972, there have been four attempts to reschedule marijuana or de-schedule it entirely. They all failed.

These findings, including recommendations for scheduling, are then submitted to the attorney general who conducts another independent review – typically delegated to the DEA – of the evidence. From there the drug will either go unscheduled, or the attorney general will initiate proceedings to create rules to schedule it accordingly.

There have been four attempts to reschedule marijuana or de-schedule it entirely. They have all been denied, including one petition—the first, filed in 1972 by by the National Organization for the Reform of Marijuana Laws (NORML)–that took 22 years to be denied.

Three subsequent petitions have all failed, most recently in 2011.

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Federal Scheduling and States

In 1996, California became the first state to legalize medical cannabis with the passing of proposition 215. Today there are 23 states with 23 different medical marijuana programs whose rules and restrictions can vary widely, with some states imposing much stricter regulations than others.

For instance, California’s Proposition 215 allows patients to possess up to 8oz of actual plant material at a time and has 13 specific qualifying medical conditions, plus the vague qualifier of, “Any other chronic or persistent medical symptom that substantially limits the ability of the person to conduct one or more major life activities or, if not alleviated, may cause serious harm to the patient’s safety or physical or mental health.”

New York’s Compassionate Care Act occupies the other end of the spectrum. It has 10 specific qualifying conditions and in the place of Prop 215’s open- ended qualifier is, “The Department of Health commissioner has the discretion to add or delete conditions and must decide whether to add Alzheimer’s, muscular dystrophy, dystonia, PTSD, and rheumatoid arthritis within 18 months of the law becoming effective.”

State Sen. Savino, who sponsored the Compassionate Care Act, says there is a good reason the CCA is so restrictive: California.

“California was the first and is the worst. It has been the wild west for 20 years, and they are only now trying to implement state-wide regulations,” Savino said, referring to recent legislative efforts to standardize medical marijuana laws across the state.

“It was their laissez-faire attitude to the implementation of [medical] marijuana that has led us here.”

Savino is talking about the ease with which residents (and even non-residents) of California can acquire a doctor’s “recommendation” to buy cannabis.

A recommendation is not the same as a prescription. FDA-approved pharmaceuticals are regulated by the DEA and cannabis is not an FDA approved drug. A prescription pad is actually a DEA form. As such, any “prescription” for cannabis would be illegal. It is the same in every state and will remain that way until the FDA approves marijuana or any of its derivatives as a pharmaceutical drug. (Marinol, while a derivative of marijuana, is a synthetic cannabinoid called dronobinal and is FDA approved, which is why it can legally be prescribed).

In California, any willing doctor can recommend cannabis to just about any patient. There are even apps that enable a user with a smartphone to get a marijuana recommendation from a physician on a video call and then home delivery from a dispensary.

Conversely, New York’s new law allows physicians to recommend marijuana only for conditions that fall under their immediate medical purview. For instance, only a pediatric neurologist can recommend cannabis to a child with severe epilepsy.

Since details of the CCA began to emerge a year ago, marijuana advocates and New York area doctors have raised concerns over the number of patients that will actually have access.

Someone who might benefit from medical marijuana may not have access to it because their specific diagnosis is not on the list covered in New York State.

“The list of diagnoses, and how sick the patients have to be to qualify for a recommendation makes it quite restrictive,” said Dr. Bernard Lee, associate chief medical officer at MJHS Hospice and Palliative care in Manhattan. “So you have this barrier, where someone who might benefit from medical marijuana may not have access to it because their specific diagnosis is not on the list covered in New York State.”

New York has also excluded smokable forms of cannabis from its program, becoming only the second state to do so. In other words, the actual marijuana flower will not be available to patients. Instead, patients visiting one of the 20 dispensaries across the state will find oil extracts that can be vaporized as well as cannabis-infused tinctures, balms and sprays.

Research like Abrams’ – that compared smoked marijuana to oral Marinol – makes a case for smoked marijuana as an effective treatment option. According to Abrams, patients preferred the fast action of inhaled cannabis and the ability to better control their own dose.

But Sen. Savino said Gov. Andrew Cuomo was adamantly against allowing people to smoke medicinal marijuana. And while she initially supported use of the whole plant in the bill, she said she realized the medicinal and societal merits of removing smoking from the equation.

“When you think about it, while smoking has always been the way people have used marijuana, it’s not the most healthy way to do it,” Savino said. “As a society we have spent billions of dollars… trying to reduce the incidence of smoking in the general public, and as a general health policy, it didn’t make sense to advocate for smoking.”

In a public policy announcement, The American Society of Addiction Medicine (ASAM) stated that it, “Rejects smoking as a means of drug delivery because it is not safe.”

According to another Abrams study that compared smoked and vaporized marijuana, the ASAM stance is not unwarranted. The study, published in 2005 in the journal, Clinical Pharmacology and Therapeutics, found that cannabinoid concentrations in the blood 30 minutes after administration were significantly higher in individuals who used vaporized marijuana, indicating a longer duration of action. Additionally, the carbon monoxide levels were significantly reduced with vaporized marijuana.

“Vaporization of marijuana was found to be a safe mode of delivery,” Abrams concluded. “Participants had a clear preference for vaporization over smoking as a delivery system for the marijuana used in this trial.”

According to the new program, medical cannabis products must also have a consistent cannabinoid profile that can be proven via independent laboratory testing. A consistent cannabinoid profile refers to uniformity throughout the product. For example, if a cannabis extract designed to help treat epilepsy has a CBD: THC ratio of 2:1 in one part of the product, it must be the same throughout and in future batches of that product.

In pursuing a more medically focused model for this new public health policy, the Compassionate Care Act includes a unique provision. There will be a trained pharmacist on site at all 20 dispensaries throughout the state. This, according to Savino, was done more for the doctors than the patients.

The government makes it very difficult to study cannabis as medicine, but you can study it as a substance of abuse... Of the 16 currently active NIDA funding opportunities, 15 focus on marijuana abuse.

“Doctors know that model so it was an effort to provide some degree of comfort to them that it wasn’t being dispensed by some guy with a weed t-shirt and long hair but by actual medical professionals,” Savino said.

Abrams, who has recommended marijuana to his own patients in San Fancisco described the situation he faces at home, “If I write a prescription for a patient with depression it says, ‘Zoloft or paxil… with the dose and the number that I want dispensed,’ and they take it to a pharmacy and that is what they get,” Abrams said. “If I write a recommendation for marijuana, the clerk at the dispensary asks if you want “Zoloft” or “Paxil” and how much and how strong and how many.

“That’s the way it is because the research hasn’t been done. The government makes it very difficult to study cannabis as medicine, but you can study it as a substance of abuse. So there is not a lot of data on which to base recommendations.”

Indeed, of the 16 currently active NIDA funding opportunities, 15 focus on marijuana abuse.

New industries have to start somewhere and for critics of the Compassionate Care Act, Savino says regulations come with the territory.

“Every industry is regulated,” Savino said, “so the concern that they’re too regulated… that’s what people say about everything; too many taxes and too many rules. But this is a special industry because of the fact that it is illegal by the federal government’s position, so you have to have a tighter model to protect doctors, patients and investors.”

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Educating Doctors

“General education for physicians is in short supply and we need it,” said Dr. Lee. “When we went to medical school, there was nothing about medical cannabis. I don’t know of any residency programs today that are training docs to use this, so it’s just not out there.”

This, according to Savino and critics alike, is a big problem. The laws are in place to protect patients and doctors, but if not enough doctors get certified to recommend marijuana, there won’t be enough patients to make a medical marijuana business profitable. A doctor’s patient is a dispensary’s customer, but without customers there is no incentive for businesses to take on the financial risk of opening dispensaries in the first place.

At the first ever Cannabis Business Summit in New York City, Lee was the only doctor present and he paid to be there. Savino believes this minimal level of doctor involvement in the legislative process is both a symptom of federal scheduling and a cause of some of the problems facing the implementation of the Compassionate Care Act.

“Even though it never happens in any other state, the biggest questions we are getting from them [doctors] is, ‘am I going to get arrested’ or ‘am I going to get sued for malpractice (because it is federally illegal),’ without realizing that other doctors in other states have been practicing medical marijuana programs and not one has been arrested or sued… They should have been more present in this discussion.”

Dr. Glenn Babus, a pain management specialist at Regional Radiology in Staten Island says there is a reason for their absence.

And again, it comes down to education, or a lack thereof.

“Physicians? Are you kidding me? Primary care doctors are going to have no clue and are not going to give two shits about medical marijuana,” said Babus. “For me, because I do pain management, I have used Marinol for years, but when doctors hear marijuana, it freaks them out. We are bad at teaching residents this stuff.”

Indeed, there is not one residency program in the United States that offers any medical marijuana education. The same goes for medical schools, which have yet to add medical marijuana to any of their curriculum. Again, federal scheduling is to blame.

Physicians in New York can get certified to recommend medical cannabis if they complete a Continuing Medical Education (CME) course. It is a 4-hour course, costing $250, that will cover the endocannabinoid system – a group of cannabinoid receptors and neurotransmitters located in the brain and throughout the nervous system – and cannabinoids. It will also provide pharmacological information like administration and dosing, drug metabolism, drug interactions and side effects.

“I think education is a good thing, and a physician should know something about medical marijuana before they can certify a patient, but the CME is not yet available,” said Lee. “It is now October 20th, and medical marijuana is rolling out in January, which is right around the corner, but that CME is not yet available.”

The CME actually became available later that same day, but it still leaves doctors a little over two months to set aside the time to take it. Lee believes this will lead to fewer certified doctors come Jan. 1st.

“For a physician who wants to recommend medical marijuana, they have to be quite motivated. Physicians are responsible for their own CMEs and have to do X amount a year to maintain their hospital privileges and that sort of thing. But it’s not the easiest thing to get a doc to set aside 4 hours of their time and pay for a CME course, so that’s another barrier. In general, there is a lot of stigma around medical marijuana and physicians need appropriate education about the benefits and the right patient types that can benefit. I assume that is what the CME will teach, but if [physicians] are already opposed to the idea based on social stigma, or they believe the patients are just drug seekers who are not getting a medical benefit, then they have no incentive to take the course.”

While the timing of the CME might leave something to be desired, Lee, Babus and other doctors in New York might consider themselves lucky to have one at all. Surprisingly – or unsurprisingly if you ask Sen. Savino – New York is one of only two states that require a CME for a doctor’s marijuana certification (Massachusetts is the other and it is half as long). That means 21 out of 23 states that have allowed medical marijuana have no formal medical education that is required for a recommending physician.

But requiring a CME to prescribe a drug is against the norm in itself. Most education about medications comes from the pharmaceutical companies that develop and sell them .

“Usually you don’t have to take a CME to prescribe a drug,” said Abrams. “But I think it answers the question of how to get physicians knowledgeable and aware so they can learn how to better use it in their patients. I think it’s not a bad idea.”

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State of the Research

“The peer review panel seemed to have missed the point,” Abrams said after the federal government rejected his second research proposal back in 1996. “The reason the substance was being studied was because it was being so widely used [by patients] in the community.”

That was the same year Californians voted to legalize medical marijuana, which the federal government responded to by threatening any physician with an interest in medical cannabis with punishments that included rescinding their license to prescribe drugs or stop them from receiving compensation from insurers.

There are an estimated 1,137,069 legal marijuana patients across the United States.

Today, after 22 more states legalized medical cannabis, “widely used in the community,” translates to an estimated 1,137,069 legal marijuana patients across the United States, according to ProCon.org, a non-profit organization that provides online resources for research.

So with over a million people in the United States looking to marijuana as a treatment option, more scientists are identifying medical cannabis as an important avenue of research.

“I thought that medical marijuana research would be addressing an important problem,” Deutsch said.

His research has focused on Cannabidiol (CBD) and its interaction with human cells in an effort to understand why CBD has the effects that it does.

CBD gained major media attention in 2012 with the dramatic success story of Charlotte Figi, a 5-year old girl with severe epilepsy whose condition improved after receiving a cannabis oil extract with a high CBD content.

The question for scientists then became, but how? The answer is marijuana, but not the kind you find in dispensaries.

All mammals, not just human beings, have an endocannabinoid system.

According to Deutsch, it acts like a system of brakes that prevent nerves from firing too much via a neurotransmitter called anandamide, a kind of “natural marijuana in the brain used for signaling.”

Anandamide is a retrograde transmitter, meaning it goes backwards, from post-synaptic cell to pre-synaptic cell, and responds when cells are firing too quickly by turning off other neurotransmitters like glutamate.

Anandamide is then transported through the cell by fatty acid-binding proteins (FABP) that carry it to fatty acid amine hydrolase (FAAH), an enzyme that breaks it down, ceasing its function.

According to Deutsch, by inhibiting FABP and FAAH, we can make anandamide work more, and that is where CBD comes in.

“FABP is like a clamshell,” Deutsch said. “So when CBD molecules go inside and fill up the clamshell… they prevent other things from going in it.

“It seems to help children with epilepsy in certain types of genetically defined conditions called dravats syndrome. People don’t really know how it works exactly, but we think it makes this brake system work better by preventing anandamide from being broken down and making your natural endocannabinoid levels go up. So we think possibly… that CBD binds and inhibits the FABP transporters. That is our proposal and maybe how CBD works in children.”

This is an important finding because it goes beyond the base claim that CBD is helpful in treating seizure disorders and provides a pharmacokinetic explanation for its mechanism of action in human cells.

One reason why CBD has moved to the forefront of medical marijuana research is that unlike THC, CBD does not have any psychoactive effects. In other words, it doesn’t get patients high, which according to Lee, is one of the goals of medical cannabis research.

“By decreasing the THC and increasing CBD or other components, people won’t get as high,” Lee said. “Having less or no psychogenic effect is the goal, while being able to provide good medical relief.”
One company, the UK-based, GW Pharmaceuticals, has taken CBD a step further with the introduction of its new epilepsy medication, Epidiolex.

Epidiolex is not FDA approved, but GW is the first pharmaceutical company to conduct FDA approved, phase III clinical trials on a cannabinoid-derived drug in the United States (Marinol uses a synthetic cannabinoid, whereas Epidiolex uses CBD that has been extracted from actual marijuana plants).

Georgia Regents University is among the facilities conducting research with Epidiolex in the United States. On Dec. 30th 2014, researchers administered the first dose of Epidiolex to a child with severe seizure disorder. Since then, 50 children have received epidiolex as part of the open-label study, and recruitment has begun for a double-blind, placebo controlled trial that will begin in March 2016.

But how have those first 50 children fared?

“We have seen improvements in patients in the number of seizures a day,” said Nancy Starnes, Nurse Clinician and study coordinator at GRU. “We have also seen behavioral improvements, so overall, very favorable results.”

Epilepsy is not the only condition being battle-tested with CBD. According to the National Cancer Institute, CBD has significant analgesic and anti-inflammatory properties and has been used to treat these symptoms associated with cancer and HIV.

Opiates like morphine have long been staples of pain management, but research suggests cannabis, used alone or in conjunction with opiates, might be a safer and more effective treatment for certain types of chronic pain.

A 2012 study led by Abrams concluded that, “vaporized cannabis augments analgesia [pain relief] in individuals with chronic pain.”

Similar to the endocannabinoid system, there is an endogenous opiate system with receptors specifically for opiates. But one major difference is that opiate receptors are closely tied with respiratory regulation while cannabinoid receptors are not. What makes opiate overdoses so dangerous is that they can cause respiratory depression—sometimes enough to cause an overdoser to stop breathing entirely.

Providing broader access to medical marijuana may have the potential benefit of reducing abuse of highly addictive painkillers.

Cannabinoids do not carry the same risk, and may even help reduce the incidence of opiate overdose. According to a 2014 study by the National Bureau of Economic Research (NBER), communities with medical cannabis dispensaries reported 15 to 30 percent fewer instances of opiate abusers and overdoses admitted to hospitals. The findings suggest, “Providing broader access to medical marijuana may have the potential benefit of reducing abuse of highly addictive painkillers.”

Babus, who has been prescribing opiates and Marinol for decades, believes that study is accurate but ultimately irrelevant when it comes to finding the best treatment option for an individual patient.

“If I think marijuana has a better chance than a narcotic to work for one of my patients, I will use it,” Babus said. “I’m not against it, but I’m also not blinded by it as the best new thing. You have to use your brain. ”

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Willful Ignorance: Guilt on both sides

Asking a marijuana advocate about the current regulations will probably elicit a strong emotional response replete with derision for the federal scheduling.

“The federal government has always been, in my opinion, willfully ignorant of the value of marijuana,” Savino said.

But ask DEA chief, Chuck Rosenberg, about medical cannabis and you will find he takes it less seriously. In early November, during a Q&A with reporters, he said, “What really bothers me is the notion that marijuana is also medicinal – because it’s not. We can have an intellectually honest debate about whether we should legalize something that is bad and dangerous, but don’t call it medicine – that is a joke.”

“What really bothers me is the notion that marijuana is also medicinal – because it’s not... Don’t call it medicine – that is a joke.” Chuck Rosenberg, Acting Administrator, DEA.

Advocates and patients responded by starting a petition for his resignation, which has since garnered over 100,000 signatures. And when you look at the credible science that is available, it might be hard not to agree with the Senator, or sign the petition yourself.

For example, a 2008, placebo-controlled study published in the journal Neuropsychopharmacology found that, “cannabis was associated with a sizeable (46%) and significantly greater (vs 18% for placebo) proportion of patients who achieved what is generally considered clinically meaningful pain relief,” and, “This study’s findings are consistent with and extend other recent research supporting the short-term efficacy of cannabis for neuropathic pain.”

It is studies like these, which seem to provide the appropriate science required to promote policy change, that have sparked the fire of advocate indignation.

But are advocates also guilty of “willful ignorance” themselves?

Of all the medical conditions that marijuana is purported to treat, none have received the social media attention that cancer has. Every day it seems there is a new article or blog post popping up on Facebook or Twitter pointing to a study or anecdotal case that indicates marijuana can cure cancer.

In one of the most commonly cited studies, Dr. Manuel Guzman, professor of biochemistry and molecular biology at Madrid Complutense University, injected concentrated cannabis oil into the brains of mice with cancer. He observed apoptosis – cell death – in some of the cancer cells. Yet Guzman himself says the current state of cannabis and cancer research is poor at best.

“Although it is possible – and of course desirable – that cannabis preparations have exerted some antineoplastic [anti-tumor] activity in some particular cancer patients, the current anecdotal evidence reported on this issue is pretty poor, and, unfortunately, remains far from supporting that cannabinoids are efficacious anticancer drugs for large patient populations,” Guzman wrote in a review of current research for Cannabis-Med.org.

But you won’t see that statement quoted in any of the hundreds of articles or advocate blogs that claim cannabis cures cancer.

Abrams, who has worked with Guzman, is even more skeptical.

“I have been an oncologist in San Fransisco for 35 years and most of my patients have used cannabis,” Abrams said. “If cannabis cured cancer, I’d have a lot more survivors. Now, you could say, ‘he’s talking about inhaled cannabis and we are talking about highly concentrated oils,’ but at this point in time, that’s pretty much snake oil in my opinion until I see some data.”

The data Abrams wants to see has nothing to do with mice, rats or cell cultures in Petri dishes, otherwise called in-vitro studies. Placebo controlled, in-vivo – Latin for, “In the living”— studies are the gold standard of science and drug development, but Abrams doesn’t see those studies happening any time soon, nor does he think they are necessary.

This is where Guzman disagrees, writing, “There are still many unanswered questions around the potential for using cannabinoids as anticancer drugs, and it is necessary and desirable that exhaustive clinical studies are conducted to determine how cannabinoids can be used, other than for their palliative effects, to treat cancer patients.”

The most promising cancer-cannabinoid research points to the efficacy of cannabinoids used in conjunction with traditional chemotherapy agents. According to a 2011 study, also involving Guzman, researchers observed that the combination “remarkably reduces the growth of [tumors]. Altogether, our findings support that the combined administration of TMZ [chemotherapy agent] and cannabinoids could be therapeutically exploited for the management of glioblastoma [brain tumors].”

The NIDA itself has admitted this is a more likely route of cannabinoid cancer treatment. According to their website, “Marijuana extracts may help kill certain cancer cells and reduce the size of others…. Research in mice showed that treatment with purified extracts of THC and CBD, when used with radiation, increased the cancer-killing effects of the radiation.”

Even though Abrams is skeptical, this finding is much more in line with his patient experience.

“Most of my patients who are very vocal about cannabis oils curing their cancers seem to forget that they also had chemotherapy,” Abrams said.

That could be the result of selective memory or it may be willful ignorance. Either way, advocates who make grand claims based on weak evidence might ask themselves if the dissemination of false or misleading information is any less harmful than the federal authorities dismissing good research as a “joke.”

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So what would rescheduling or de-scheduling actually do for this country?

A common misconception is that rescheduling marijuana to a Schedule II substance would immediately cause sweeping policy changes across the country.

When the DEA reschedules a drug, the Uniform Act requires the states to reschedule the drug accordingly. In most cases states adhere to federal regulations, but states can object to the scheduling and opt for more stringent regulations, however not more lax.

A common misconception is that rescheduling marijuana to a Schedule II substance would immediately cause sweeping policy changes across the country.

According to the Brookings report, rescheduling would not signify the drug as “safe” or make any subjective judgment about the dangers of taking it, but it would make research more accessible to interested parties.

If cannabis is changed to a schedule II substance, doctors could then apply for a practitioner’s license to conduct clinical trials with their patients. This is an important avenue of research because it provides doctors the opportunity to experiment with highly individualized treatment regimens and observe those patients over a longer period.

According to Abrams, this is the kind of research that’s needed.

“The evidence has to come from the people who are on the front lines and working with patients who say, ‘Oh, this works best for my nausea,’ but that is highly personalized medicine. It is not one size fits all.”
De-scheduling marijuana entirely, in addition to clipping the leash that has held researchers back for all these years, would also address many of the social ramifications of marijuana prohibition and scheduling.

While states could still regulate marijuana as they see fit, people incarcerated on simple marijuana possession might see reduced sentences. Prisons themselves would see less non-violent offenders walk through their doors in the first place since marijuana accounts for over 80 percent of drug arrests in this country.

Marijuana businesses in Colorado and across the country would finally gain access to banking services and tax breaks that every other business in the country is entitled to.

And while Abrams has voiced support for de-scheduling marijuana entirely and regulating it like alcohol, he has concerns over how that might impact the standard of medical cannabis.

“My concern for outright legalization is whether or not my patients who are using cannabis will be able to get the same high quality product that has detailed pharmacological information about what it is and what’s in it,” said Abrams. “Because people who are only interested in recreational [marijuana] might not be as interested in knowing some of the finer details and I would like those standards to be upheld.”

For doctors, researchers and patients, the answer is clear: more research is needed. Whether that involves rescheduling or de-scheduling cannabis entirely is an issue for the bureaucrats in Washington D.C. to decide.

As a society, Abrams believes it is a matter of changing how we think about marijuana in the first place.

“Cannabis has been medicine for 3000 years – a lot longer than it hasn’t been a medicine – which is about 74 years,” Abrams said. “But doctors have been trained in these last 74 years when cannabis has been prohibited, so now if people want to get modern and learn about cannabis, you need to think about cannabis as medicine.”