A Modest Proposal (Thanks to Jonathan Swift—1667-1745)
YALE, 1981— I was walking down the hall with William Collins, MD, chairman and Cushing professor of neurosurgery, talking about the Pain Clinic. He told me about a case of a man in his mid-30s suffering from intermittently moderate to severe rectal spasms, which had failed to respond to multiple therapies for more than a decade. To prevent exacerbations, the patient sat on his hand 10 hours per day, massaging his anus until he passed out, leaving him socially isolated with suicidal thoughts. Dr. Collins’ team was seriously considering performing a prefrontal lobotomy to “distance” the patient from his pain.
Fast forward to the present. In today’s climate, in which Physicians for Responsible Opioid Prescribing (PROP) has petitioned the FDA to revise opioid labeling,1 this non-cancer pain patient would not qualify for >90 days of opioid therapy at >100 mg morphine equivalent per day. It would somehow be OK to receive such therapy, however, if he were dying of rectal cancer. If the patient was lucky, he would die within 90 days and we would not have to worry about him becoming an addict (even though he had never shown addictive behavior through all his other therapies and the calculated risk of him becoming addicted is 0.27%).2
Legislating Prescribing Practices
I must admit my first reaction when I read about the PROP petition was to be incredulous. I couldn’t believe that pain management doctors were doing this—cutting off their own legs with regulation. [Editor’s Note: PROP argues that they are not prohibiting prescribing of opioids beyond 90 days or interfering in any way with clinical decision-making, but rather trying to limit pharmaceutical companies’ claims of long-term efficacy of opioid therapy in chronic non-cancer pain.3] Most of my practice consists of non-cancer pain patients who fail on the recommended course of therapy. I had treated patients for years (decades) successfully with opioids at doses even higher than the PROP guidelines allowed. By going to the FDA, PROP was making no practice distinction between pain specialists and primary care doctors; we were to take over their failures, but had no flexibility under PROP’s guidelines.
I foresaw a future similar to that adopted by Blue Cross Blue Shield (BCBS) of Massachusetts in July 2012 in which a doctor could only prescribe a 30-day supply of short-acting opioids, with any further treatment requiring prior authorization4 by an anonymous panel of people who don’t have my training, experience, and personal responsibility to my patient. [Editor’s Note: The BCBS policy does not apply to cancer patients or the terminally ill patient.]
Medicare and private insurance company panels would use the FDA package insert statements as a de facto standard of care, even though the FDA does not have the authority to regulate the practice of medicine and does not limit medical practitioners in this way. (It recognizes that medical practice discovers new uses for drugs that were not initially considered or tested by their developers.) Even the treasurer of PROP, Steve Gelfand, MD, in discussing these issues, described the roughly 10% of end-stage arthritis patients in his own rheumatology practice “who did well on low doses of opioids.”5,6 He would not be able to treat his own patients under the recommendations his organization has petitioned to the FDA. In aggregate, millions of such patients would not receive effective pain treatment, a situation I consider unethical if not frank malpractice. (It is estimated that 16 million Americans suffer from osteoarthritis while 2.1 million Americans have rheumatoid arthritis.7)
Our colleagues make their recommendations with good intentions. They are concerned about public health issues of rising overdose deaths and diversion to abusers and addicts coincident with the increased prescribing by doctors of opioids for non-cancer pain. These grave statistics were highlighted in two reports. The Centers for Disease Control and Prevention reported that in 2008, 14,800 Americans died from prescription painkiller overdoses, more than the total of accidental deaths caused by cocaine and heroin combined.8 In 2010, an estimated 5.1 million people used prescription pain relievers for nonmedical reasons during the previous year, according to a survey by the federal Substance Abuse and Mental Health Services Administration. More than half of those surveyed said they got the prescription pain relievers for free from friends or family members.9
One argument of PROP is that there is no evidence chronic opioid therapy helps to treat chronic pain. However, most studies do show approximately 20% to 30% improvement in global pain scores with current therapies using opioids as mainstay. A recent Cochrane Library review of clinical practices, chosen across all 52 Cochrane Collaborative Review Groups and based on randomized controlled trials (the “gold standard” of evidence-based medicine), found only 45.3% of interventions likely to be beneficial.” Ninety-eight percent of those recommended further studies before they could be considered actually established.10 By these criteria, we should all just pack up and go home.
As a psychopharmacologist, medical historian, and addiction medicine specialist, I have reviewed thousands of years of psychoactive drug use in multiple cultures. Insects, mammals, birds, and humans all show a proclivity to use substances to modify their thinking and behavior.11 Attempts to limit use of opioids by legislation in larger urban cultures have never succeeded in eliminating an established drug habit from a culture. Their use naturally waxes and wanes in a negative feedback oscillation as experienced users lose their curiosity and remember their adverse experiences, only to be replaced by a new group of curious naïve potential users. Prohibition drives drugs to become more potent (easily smuggled), adulterated (dangerous cheap substitutions), more expensive (driving criminal enterprises and profits), and converts users to incarcerated criminals. Controlling the supply—the so-called “War on Drugs”—is obviously lost; it must become a therapeutic, demand-side endeavor to us all. (Yet the World Health Organization reports that in countries where evidence-based addiction treatment is available, only 1 in 5 patients get such treatment.12)
Arbitrary limitations on the supply of prescribed opioids at the government level will force us back to the old prohibition before pain management was established as a specialty, stigmatizing the drugs and driving the millions of chronically pained American citizens, with and without cancer, back to buying drugs on the streets to relieve their agony. Resources need to be directed to make education and drug treatments more available for addicts, probably in multispecialty clinics prepared to handle all the complexities of pain treatment as well. Doctors are easy targets with their reputations and licenses on the line, as they were after World War I, when the US government passed an act making it illegal to give prescriptions to maintain opium addicts (we would call most of them arthritic grandmothers).13 Limiting our pain management resources and judgment can’t make teenagers stop taking drugs at parties.