Medical marijuana is legal in 20 states and the District of Columbia, with pending legislation to legalize the drug for medical purposes in 4 others.[1] Although still illegal in 30 states, millions of patients are undoubtably using marijuana for medicinal purposes in these jurisdictions.

Much has been written about politics trumping science with respect to rescheduling marijuana from a Schedule I drug,[2-5] as its medical benefits become progressively more accepted by the mainstream medical community as well as the general public.[6] The Veterans Administration, which is becoming a leader in pain care in the United States, has even approved of its physicians authorizing medical marijuana in states in which it is legal.

Earlier this year, Kondrad and Reid[8]published a large-scale survey-based study of family physicians’ attitudes toward medical marijuana in Colorado — a state in which medical marijuana has been legal since 2000. The results of their investigation were both startling and disturbing. They found that only 19% of respondents believed that physicians should recommend medical marijuana to their patients. However, they also found that 80% of respondents believed that education about medical marijuana should be incorporated into medical school curricula, 82% believed that such education should be included in family practice residency training, and 92% agreed that continuing medical education on medical marijuana should be made available to them. Opposition to recommending medical marijuana as a result of concerns about legal liability or licensure was reported by 23% of respondents, whereas only 13% cited a lack of medical evidence as their reason for opposition. These figures indicate that science is clearly not the primary issue of concern.

These intriguing data tell us that a lack of education is the primary cause of physicians’ discomfort in recommending medical marijuana. Schatman recently addressed the ethical imperative for physicians to consider medical marijuana as a part of their pain management armamentaria. This is particularly important, given the lack of an evidence base for chronic opioid therapy and physicians’ reluctance to prescribe opioids in this era of fear of legal and regulatory sanction.

Why So Reluctant?

In clinical practice, physicians have been found to refuse to authorize medical marijuana out of concern that doing so will place their controlled substances licenses in jeopardy. Although 20 states have “legalized” medical marijuana, it remains a violation of the federal Controlled Substances Act, and the reality of the license to prescribe controlled substances being issued by the US Department of Justice’s Drug Enforcement Administration (DEA) clearly has served, for many physicians, as a deterrent to the authorization of medical marijuana.[10] Physicians who treat patients with chronic pain rely on their abilities to prescribe controlled substances, and fear of losing the privilege to do so has resulted in an unfortunate reluctance to authorize what can be an extremely effective and relatively safe alternative to opioid analgesics.[9]

An unintended consequence of this fear has been naturopathic doctors (NDs) developing “doc-in-the-box” medical marijuana authorization practices in states in which NDs are permitted to authorize medical marijuana. These practices are often cash-only entities; this is particularly troubling in such states as Washington, in which health insurers are required to compensate NDs. Given the financial incentives, these naturopathic providers have loose and easy criteria for authorization of medical marijuana, because they have no controlled substance registrations to lose.[11]

The result is that many recreational users are obtaining legal access to high-tetrahydrocannabinol (THC) “medical marijuana” at a relatively low price from dispensaries. However, a small number of allopathic and osteopathic physicians have overcome their fears of legal and regulatory sanction and have brazenly developed specialized practices consisting primarily of medical marijuana authorization, without expertise in the treatment of the conditions for which they are authorizing its use.

Under the proposed label changes, opioids would no longer be indicated for moderate noncancer pain. The petition notes that moderate to severe pain is the FDA-approved indication for nearly all instant-release opioids as well as extended-release versions when 24/7 pain relief is needed for a long stretch of time. Such “overly broad indications” imply that the FDA has established that long-term use of opioids is safe and effective, the petition states. “An increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses.”

In addition, the maximum daily dose would be the equivalent of 100 mg of morphine, and the maximum duration for continuous daily use would be 90 days under the proposed label changes. Both limits would apply to noncancer pain.

One of the petitioners, Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing, told Medscape Medical News that the label changes would not prevent physicians from prescribing opioids at doses and durations that they deem appropriate for patients on a case-by-case basis. However, the changes would limit claims that drug companies can make about their products.

“Right now, drug companies are promoting long-term opioids as proven safe and effective for chronic pain,” he said. “They’ll promote [them] for lower back pain, fibromyalgia, osteoarthritis, whatever they want…because the current label is like a blank check.”

“By prohibiting the aggressive marketing, we can reduce the overprescribing,” said Dr. Kolodny. Physicians who understand that opioids are not necessarily safe and effective long term may resort to other treatments such as behavior modification, physical therapy, and weight loss, he added.

Other physicians signing the petition include

• Roger Chou, MD, Associate Professor of Medicine, Oregon Health & Science University
• Edward Covington, MD, Director, Neurological Center for Pain, Cleveland Clinic
• Stuart Gitlow, MD, MPH, Acting President, American Society of Addiction Medicine
• Elinore McCance-Katz, MD, PhD, Professor, Department of Psychiatry, University of California–San Francisco
• Nirav Shah, MD, MPH, Commissioner, New York State Department of Health
• Sidney Wolfe, MD, Director, Health Research Group at Public Citizen

Label Change Called Necessary for Effective REMS

The petition to revise the label of opioid analgesics comes on the heels of a new FDA initiative to help turn the tide of the prescription painkiller epidemic, which is causing more fatal overdoses than cocaine and heroin combined, according to the US Centers for Disease Control and Prevention. Earlier this month, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids prescribed for moderate to severe chronic pain. More than 20 opioid manufacturers must make available to prescribers continuing education programs on the proper use of these drugs. This education will be funded through grants from manufacturers to continuing medical education providers, who will develop the training based on a blueprint for content provided by the FDA and will deliver the training.

Dr. Kolodny told Medscape Medical News that the REMS for opioids “isn’t going to help and could potentially make things worse.”

Without the label change sought by his coalition, he said, the REMS curriculum would still leave doctors “with the false impression that long-term opioid therapy was proven safe and effective.”

One company that would be affected by the envisioned label change is Purdue Pharma, the maker of controlled-release oxycodone (OxyContin), which is indicated for moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. When asked to comment on the petition to the FDA, Purdue Pharma issued a statement saying, “[The] FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate.

“We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges,” the company added.

Ensure Opioid Availability for Legitimate Need, Cautions Pain Expert

One pain expert interviewed by Medscape Medical News sounded a cautionary note about the petition submitted to the FDA about revising opioid labels.

“I share the concern of this group,” said Charles Argoff, MD, a professor in the neurology department at Albany Medical College and director of the Comprehensive Pain Program at Albany Medical Center in New York. “However, we need to establish prospectively whether this approach accomplishes what this petition suggests it would. This group has yet to prove that the recommendations in the petition are appropriate recommendations.”

Any changes to opioid labeling must be anchored “in the highest-quality medical evidence,” said Dr. Argoff, a member of the editorial advisory board for Medscape Neurology. Otherwise, patients could suffer harm.

“We have a prescription drug abuse crisis…that we must combat,” he said. “But [the petition] does not address the millions and millions of people who have been appropriately prescribed this medication, who have been appropriately monitored, and who have lived a more functional life as a consequence. We need to ensure the availability of these drugs for patients who can benefit from them and establish concrete approaches to limiting the abuses and misuses.”

Dr. Argoff has spoken out in the past on the problem of “allowing physicians with insufficient training to prescribe medications that can kill people.” He reiterated that concern in his remarks on the opioid-labeling petition.

“To demonize the drug is ignoring the responsibility of the prescriber,” he said. (Robert Lowes)