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ASRA Pushes for Medical Cannabis Rescheduling

November 1, 2016
The American Society of Regional Anesthesia and Pain Medicine (ASRA) is calling for the rescheduling of cannabis to a Schedule II classification, citing the need for more clinical research into the substance's possible medical benefits.

Interviews with Samer Narouze, MD, PhD, and W. David Bradford, PhD

While lawmakers in Washington continue to uphold the federal government’s Schedule 1 status for cannabis, practitioners are now lending their own voices to the debate.

The American Society of Regional Anesthesia and Pain Medicine (ASRA) recently released a public statement strongly encouraging the federal government to reschedule cannabis to a Schedule II classification.1

By rescheduling medical cannabis, researchers could expand clinical trials to verify the limited data that currently exists.A Schedule II classification would allow researchers more easily to study cannabis in clinical trials, expanding literature into the agent’s possible medical benefits.

While sparse, existing literature does suggest medical cannabis could be a valuable therapeutic option for patients suffering from a variety of pain conditions, including multiple sclerosis (MS),2-4 cancer pain,5 chronic neuropathic pain,6-7 and rheumatic diseases.8-9

However, clinicians are in need of more professional consensus about medical marijuana’s indications, and the general lack of clinical evidence into its long-term effects, drug interactions, and toxicity has prevented doctors from making informed clinical decisions with their patients, particularly in the 25 current states (including Washington DC) that have medical marijuana laws on the books.

“It’s extremely, extremely difficult to conduct any clinical research on this subject to re-validate the conclusions from the available literature,” Samer Narouze, MD, PhD, a clinical professor of anesthesiology and neurological surgery at Ohio University and Ohio State University (OSU), told Practical Pain Management. “Rescheduling would allow FDA supervision, and it would allow the regulatory actions of the FDA, and this will definitely enforce safety.”

Medical Cannabis: A Federal Stalemate

According to Dr. Narouze, who serves on the board of directors for the ASRA, existing research makes it difficult for federal lawmakers to uphold the notion that cannabis holds "no currently accepted medical use," according to the language contained in the Controlled Substances Act. Still, current Schedule 1 classification of cannabis has prevented substantial cannabis research from being conducted in the US.

It’s become a catch-22 for clinicians: medical cannabis has no federally-approved indications, yet remains an approachable topic of serious clinical research. And while the federal Drug Enforcement Agency (DEA) recently announced plans to end restrictions on marijuana supplies to researchers and companies, the ASRA now has come out as one of the first professional organizations to publicly petition for a rescheduling of cannabis for the purpose of medical research and development.

Medical cannabis "is not under the microscope of the FDA because we currently use it in individual states that allow it,” said Dr. Narouze. As long as half the states in the country permit the sale of medical cannabis products, doctors have virtually no way to vet the quality and safety of the cannabis products their patients may use to treat their chronic pain symptoms.

“Dosage is a major concern for clinicians. If you cannot control the dosage, you cannot control the compounds,” he noted. The lack of regulation makes it difficult for clinicians to know how potent a medical marijuana product is and what other substances may be inside the product not mentioned by the product’s packaging or seller, Dr. Narouze explained.

Marijuana: A Timely Clinical Topic for Discussion

Such concerns have become prevalent for the ASRA member base, which includes about 5,000 active practitioners, many of whom are practicing anesthesiologists and interventional pain specialists. It’s a cross section of professionals that could bring a notable clinical perspective to this contentious subject, Dr. Narouze explained, especially during a period in US history where deaths due to prescription opioid overdose have dramatically risen.

[Editor's Note: the majority of opioid overdose deaths occur in people abusing prescription medications, not among chronic pain patients who properly use their medications.]

In Dr. Narouze’s own home state of Ohio, over 3,000 people died from opioid-related deaths—more than the rate of car accidents. “And this is a preventable cause of death,” Dr. Narouze added. Given the National Institutes of Health’s (NIH) new initiative to curb this public health crisis, it should be 1 of their main priorities to enable the research and development of medical cannabis products, especially smoke-free preparations, to be explored as analgesic alternative to opioid medications for the US population, said Dr. Narouze.

Indeed, Massachusetts Senator Elizabeth Warren had pushed for the Centers for Disease Control and Prevention (CDC) to investigate the medical benefits of cannabis as a nonopioid alternative for pain management. The Senator’s statements were back in February, when the CDC had announced a resolution to draft a guideline for prescribing opioids for chronic pain conditions.

The CDC guidelines have since developed considerable contention and confusion within the medical community. One prevailing concern expressed by practitioners at this year’s annual PAINWeek conference was the fact the CDC neglected to provide any guideline at all on the use of medical cannabis products for chronic pain conditions, an oversight that has left many practitioners in the crossfire between public policy and patient care.

“The newly released CDC guidelines honestly were not clear at all about this issue,” which has led practitioners to interpret the guidelines differently, Dr. Narouze noted.

Some practitioners may feel that it is acceptable for patients to be using marijuana if they test positive for it, and those practitioners even may abstain from further testing them. In states where there are no medical marijuana laws, many doctors consider the drug an illicit substance, as well as a legal liability, and even may refuse further care to patients who test positive for the drug while on an opioid prescription.

According to Dr. Narouze, because of the apparent deficiencies in the CDC guidelines, doctors must anchor their clinical policy off of state laws and guidelines.

If patients are using marijuana to help relieve them from cancer-related pain or nausea, this would be an approved indication for medical cannabis. Doctors need to know why the patient is taking the marijuana. Recreational use should be considered illicit. For an approved indication, clinicians still need to be aware of any possible drug interactions if the patient is taking other medications along with the marijuana, Dr. Narouze said.

Federal Entitlement Data Suggests Chronic Pain Patients Prefer Cannabis

New research suggests the adoption of medical cannabis is having a fiscal effect on entitlement programs.10

According to data from all prescriptions that were filled by Medicare Part D beneficiaries from 2010 to 2013, states saw a noticeable decrease in the rate of prescriptions for drugs that medical cannabis could be considered an alternative for.

This led to a sizeable drop in Medicare Part D spending, where national overall reductions and enrollee spending were estimated to have dropped by $165.2 dollars in 2013.

“When cannabis is available medically, physicians prescribe fewer of the drugs that are in some sense clinical substitutes for marijuana. This is highly consistent with medical usage of cannabis and not at all what one would expect if marijuana had ‘no medically accepted uses,’” said W. David Bradford, PhD, an adjunct professor of economics and the Busbee Chair in Public Policy in the Department of Public Administration and Policy at the University of Georgia.

“The key to Schedule 1 status is that there is no medically acceptable uses. The medical societies’ endorsements fly directly in the face of that and are, in my view, prima facie evidence that Schedule 1 is inappropriate,” Dr. Brisbee told Practical Pain Management.

Indeed, some of the evidence suggests much of these savings to Medicare resulted from beneficiaries paying for marijuana out-of-pocket, and according to Dr. Brisbee, the savings appear to be even more profound for Medicaid. “I think it's fair to say that Medicare benefits (fiscally) from having medical marijuana be entirely out-of-pocket for patients,” said Dr. Brisbee.

It’s a phenomena Dr. Narouze has witnessed within his own practice. Patients with nerve pain often will drop their opioid prescription when given the ultimatum between marijuana and opioids.

If patients are looking for inebriation or are at high risk of addiction, they likely will opt to hold on to their opioid prescriptions. But if patients are desperate for pain relief, they seem readily willing to drop their opioid prescription and stick with cannabis, Dr. Narouze noted.

“It’s not because they are addicted to marijuana. I think it’s because it works.”

To read the full official position by the ASRA, click here.

Last updated on: November 2, 2016
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Legal Considerations of Medical Marijuana
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