By Henry I. Miller, M.S., M.D. and Josh Bloom, Ph.D.
The ongoing battle to control opioid addiction has not gone well. Many of the government’s efforts have been medically and scientifically flawed and unproductive. Some have even been counterproductive. Public policy is in disarray.
A Feb. 1 article in the Journal of the American Medical Association concluded, “Under current conditions, the opioid overdose crisis is expected to worsen — with the annual number of opioid overdose deaths projected to reach nearly 82,000 by 2025, resulting in approximately 700,000 deaths from 2016 to 2025.” But here’s the rub: In their system dynamics model, preventing prescription opioid misuse alone would have only a modest effect — a few percent — on lowering opioid overdose deaths in the near future.
In spite of abundant commentary that suggests otherwise, the crux of the problem is not physician-prescribed opioids, but illegal supplies smuggled from abroad. Nevertheless, the federal and state governments are focusing on prescriptions. It reminds us of the old joke about the drunk who’s hunting for his lost keys under the lamppost, not because he thinks they’re there, but because that’s where the light is good.
It should come as no surprise that with bureaucrats and politicians making policy on the basis of flawed assumptions, the outcomes are poor. And patients are paying the price.
Bureaucrats are now dictating not only acceptable prescribing practices of opioid painkillers, but also how much can be manufactured. This power grab is both unprecedented and disturbing, and patients who need these pain medications, which are unrivaled for efficacy, are suffering.
One example of wrong-headed policy was President Trump’s asking then-Attorney General Jeff Sessions to sue opioid manufacturers, and another was a rule issued last July that gives the Drug Enforcement Administration unprecedented authority to set annual opioid production limits: “If DEA believes that a particular opioid or a particular company’s opioids are being diverted for misuse, this allows DEA to reduce the amount that can be produced in a given year.” In August, the feds did, in fact, propose cutting manufacturing 2019 quotas for six commonly abused prescription opioids by an average of 10 percent.
Enter the law of unintended consequences. Opioids, including fentanyl, morphine, and hydromorphone, some of our most important and potent analgesics, which are commonly used in patients with advanced cancer and for pain control after surgery, are now in shortage, according to the Food and Drug Administration. All of these drugs had their manufacturing quotas reduced by the feds.
Thus, the feds’ actions have succeeded not in ameliorating the scourge of opioid abuse and overdoses, which results from drugs made in China and elsewhere abroad smuggled across our borders, but in unnecessarily causing several other problems. These include a shortage of critical drugs produced by legitimate manufacturers and expanding the market and boosting the street price for illegal, dangerous imports.
Common misconceptions about the nature, extent, and causes of opioid addiction have led to this wrong-headed government interference. For example, President Trump has said, “People go to the hospital for a period of a week and they come out and they’re drug addicts,” but that is a myth.
True addiction in pain patients is rare. Many scholarly reviews have concluded that the addiction rate is less than one percent even in patients who have required long-term opioid medication for severe pain due to injury or illness. The current death toll from opioid use is largely the result of abuse, not medical use, of these drugs. And yet, as of last October, 33 states had instituted laws that restrict opioid prescribing in some way.
For example, Florida has a three-day limit on prescribed opioids, with the possibility of a seven-day supply if strict conditions are met. Massachusetts limits first-time patients to a seven-day supply and forbids a second prescription until the first expires. And nationwide, millions of pain patients, even those who were functioning well with long-term opioid therapy, are being forcibly tapered or having their medicines stopped outright, regardless of their wishes or those of their physicians.
This is bad public policy and bad medicine. After surgery, for example, we know that post-operative pain varies widely from patient to patient, so a standardized, one-size-fits-all dose of an analgesic is inappropriate and will also fail those afflicted with other kinds of pain, both acute and chronic. The principles of pharmacology tell us why.
The effect of a drug on an individual is directly related to body weight, and also to the efficiency of drug metabolism. The rate of metabolism of opioids can vary as much as 30-fold from one individual to the next because of genetic differences in the enzymes found in the liver and in bacteria in the gut that are responsible for the degradation of the drugs. This means a given dose of an opioid could be dangerously high for one person while too low to be effective for another.
If the science is bad, the legal precedents are worse. In the mad rush to address a complex problem with simplistic thinking, there has been an insidious but largely ignored trend toward state governments and federal agencies, in effect, writing prescriptions. In a country so respectful of individuals’ rights, how could we surrender the sanctity of the patient-physician relationship without a whimper.
The decadeslong war on drugs, which has never succeeded in controlling abuse or addiction, has now mistakenly declared American drug companies and doctors to be the enemy. In the name of addressing a crisis, we are focusing on the wrong targets and sacrificing freedoms in a new, dangerous way. That’s a prescription for disaster.