It seems that no amount of data-driven information can get policymakers to reconsider the hysteria-driven pain prescription policies they continue to put in place.
I can understand lay politicians and members of the press misconstruing addiction and dependency, but there is no excuse when doctors make that error. Yet National Public Radio reports that surgeons in 18 Upstate New York hospitals have agreed on an initiative to limit the amount of pain medicine they will prescribe to postoperative patients discharged from the hospital. The reporter says that researchers “now know” that patients prescribed opioids for postoperative pain “can become addicted” and that “the new prescription guidelines can prevent this particular gateway to abuse.”
But what does the research show? One recent study published in the BMJ of more than 568,000 “opioid naïve” postsurgical patients followed for 8 years found a total “misuse” rate of 0.6 percent. (“Misuse” includes a range of non-prescribed drug use, from self-medicating with leftover pills to treat an ankle sprain on one extreme to addiction on the other.) Broken down further, the researchers found the misuse rate was 0.15 percent in patients given just one prescription postoperatively and was 0.29 percent in patients who got a second prescription as a refill.
Multiple highly-respected Cochrane systematic analyses, the most rigorous reviews in the medical science literature, found the addiction rate in chronic noncancer pain patients on long-term opioid therapy to be around 1 percent.
Addiction and dependency/tolerance are two separate entities, but policymakers and many in the media equate the two. But the doctors in Upstate New York should know better. Physical dependence refers to the physiological adaptation to the drug such that abrupt cessation or tapering off too rapidly can precipitate a withdrawal syndrome, which in some cases can be life-threatening. Tolerance is an aspect of physiological adaptation, in which increasing dose of a medication become necessary to achieve the desired effect. Once a patient is properly tapered off of the drug on which they have become physically dependent, they do not feel a craving or compulsion to return to the drug. Dependence and tolerance are seen with numerous types of drugs, from anti-depressants and anti-epileptics to beta-blockers (used to treat hypertension and other cardiovascular conditions).
Addiction, on the other hand, is defined by the American Society of Addiction Medicine as a “chronic disease of brain reward, motivation, memory and related circuitry…characterized by the inability to consistently abstain, impairment in behavioral control, craving” that continues despite resulting destruction of relationships, economic conditions, and health. Addiction has a biopsychosocial basis with a genetic predisposition and involves neurotransmitters and interactions within reward centers of the brain. Some experts believe addiction is a learning disorder in which behavioral patterns are automatized as mechanisms for coping with stress or trauma. A major feature of addiction is compulsiveness. This compulsiveness is why alcoholics or other drug addicts will return to their substance of abuse even after they have been “detoxed” and despite the fact that they know it will further damage their lives.
Writing in the New England Journal of Medicine in 2016, Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse explained, “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.”
In February of this year, I co‐authored a paper in the Journal of Pain Research explaining why there is no correlation between the amount of opioids prescribed and the incidence of non‐medical use or prescription pain‐reliever use disorder. That same month my colleague Jeffrey Miron and co‐authors revealed similar findings in this Cato Institute Policy Analysis.
Now researchers in Germany have provided more evidence to pour cold water on the idea of any relationship between the volume of opioid prescribing and the incidence of opioid use disorder. Publishing in the German Medical Association’s international science journal, they found that “the number of persons addicted to opioids in Germany has hardly changed over the past 20 years,” with an average of 3.1 persons per 1000 inhabitants across Germany. This compares to data from the U.S. National Survey on Drug Use And Health showing no significant change in “pain reliever use disorder” in persons aged 12 and above from 2002–2014.
Germany ranks second only to the U.S. in opioid prescription volume. Canada and Australia rank third and sixth respectively. An international group of investigators recently compared the opioid prescription volume per capita of Canada, Australia, Germany, and the U.S., from 1980–2015 using data provided by the International Narcotics Control Board and the World Health Organization. In the U.S., opioid volume (measured as morphine milligram equivalents per capita) began to increase in the late 1980s, accelerated in the mid‐90s, and then surged in the early part of this century, peaked in 2012 and then began to taper. In Germany the increase in prescribing began slightly later than in the U.S.—in the mid‐90s. But, as in the U.S., it surged in the early 2000s, peaked in 2012, and then began to recede. (The prescribing patterns followed similar trend lines in Australia and Canada but had not shown any evidence of peaking by 2015.)
A big takeaway is that, just as there is no correlation between prescription volume and opioid use disorder in the U.S., so too there is no correlation between prescription volume and addiction in Germany. But another point of comparison must not go unnoticed: the U.S. leads the developed world in per capita opioid‐related overdose deaths, while Germany’s overdose rate is among the lowest in the developed world.
Germany’s overdose rate has been essentially unchanged for most of this century. Opioids were considered responsible for just under 800 overdose deaths in 2016, compared to more than 42,000 deaths in the U.S. that year. Also unlike the U.S., Germany has embraced harm reduction strategies for the treatment of substance use disorder and non‐medical drug use for decades. These strategies include Safe Injection Facilities, needle exchange programs, Medication Assisted Treatment and Heroin Assisted Treatment, and distribution of test strips and naloxone.
U.S. and state policymakers remain obsessed over curtailing the prescription of opioids to patients in pain while the overdose rate continues to climb and patients suffer needlessly. To reduce overdoses, U.S. policy must shift from a war on drugs to a war on drug‐related deaths. This means following Germany’s example and making harm reduction the central goal.
We learned last week that the 2017 drug overdose numbers reported by the US Centers for Disease Control and Prevention clearly show most opioid-related deaths are due to illicit fentanyl and heroin, while deaths due to prescription opioids have stabilized, continuing a steady trend for the past several years. I’ve encouraged using the term “Fentanyl Crisis” rather than “Opioid Crisis” to describe the situation, because it more accurately points to its cause—nonmedical users accessing drugs in the dangerous black market fueled by drug prohibition—hoping this will redirect attention and lead to reforms that are more likely to succeed. But the media and policymakers remain unshakably committed to the idea that the overdose crisis is the product of greedy pharmaceutical companies manipulating gullible and poorly-trained doctors into over-prescribing opioids for patients in pain and ensnaring them in the nightmare of addiction.
As a result, most of the focus has been on pressing health care practitioners to decrease their prescribing, imposing guidelines and ceilings on daily dosages that may be prescribed, and creating surveillance boards to enforce these parameters. These guidelines are not evidence-based, as Food and Drug Administration Commissioner Scott Gottlieb seems to realize, and have led to the abrupt tapering of chronic pain patients off of their medication, making many suffer desperately. An open letter by distinguished pain management experts appeared last week in the journal Pain Medicine criticizing current policies for lacking a basis in scientific evidence and generating a “large-scale humanitarian issue.”
Current policy has brought high-dose prescriptions down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year. Yet overdose deaths continue to mount year after year, up another 9.6 percent in 2017.
One might expect the obvious prevalence of heroin and illicit fentanyl among overdose deaths would make policymakers reconsider the relationship between opioid prescribing, nonmedical use, and overdose deaths. The data certainly support viewing the overdose crisis as an unintended consequence of drug prohibition: nonmedical users preferred to use diverted prescription opioids and, as supplies became tougher to come by in recent years, the efficient black market responded by filling the void with cheaper and more dangerous heroin and fentanyl.
The National Center for Health Statistics (NCHS) just issued Data Brief Number 329, entitled “Drug Overdose Deaths in the United States, 1999–2017.” Drug overdose deaths reached a new record high, exceeding 70,000 deaths in 2017, a 9.6 percent increase over 2016. That figure includes all drug overdoses, including those due to cocaine, methamphetamines, and benzodiazepines. The actual breakdown according to drug category will be reported in mid‐December. However, estimates are opioid‐related deaths will account for roughly 49,000 of the total overdose deaths.
The big takeaways, quoting the report:
- The rate of drug overdose deaths involving synthetic opioids other than methadone, which include drugs such as fentanyl, fentanyl analogs, and tramadol, increased from 0.3 per 100,000 in 1999 to 1.0 in 2013, 1.8 in 2014, 3.1 in 2015, 6.2 in 2016, and 9.0 in 2017.The rate increased on average by 8% per year from 1999 through 2013 and by 71% per year from 2013 through 2017.
‑The rate of drug overdose deaths involving heroin increased from 0.7 in 1999 to 1.0 in 2008 to 4.9 in 2016. The rate in 2017 was the same as in 2016 (4.9).
‑The rate of drug overdose deaths involving natural and semisynthetic opioids, which include drugs such as oxycodone and hydrocodone, increased from 1.0 in 1999 to 4.4 in 2016. The rate in 2017 was the same as in 2016 (4.4).
‑The rate of drug overdose deaths involving methadone increased from 0.3 in 1999 to 1.8 in 2006, then declined to 1.0 in 2016. The rate in 2017 was the same as in 2016 (1.0).
Despite the fact that overdose deaths from prescription opioids—and even heroin—have stabilized, the overdose rate continues to climb due to the surge in fentanyl deaths.
This has happened despite policies in place aimed at curtailing doctors from prescribing opioids to their patients in pain. Prescription surveillance boards and government‐mandated prescribing limits have pushed prescribing down dramatically. High‐dose prescriptions were down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year.
Policies aimed at curbing prescribing are based on the false narrative that the overdose crisis is primarily the result of greedy drug makers manipulating gullible doctors into overtreating patients in pain and hooking them on drugs. But as I have written in the past, , the overdose crisis has always been primarily the result of non‐medical users accessing drugs in the dangerous black market that results from prohibition. As the supply of prescription opioids diverted to the underground gets harder to come by, the efficient black market fills the void with other, more dangerous drugs. Lately, the synthetic opioid fentanyl has emerged as the number one killer.
In a New York Times report on the matter today, Josh Katz and Margot Sanger‐Katz hint that policymakers are aiming at the wrong target by stating, “Recent federal public policy responses to the opioid epidemic have focused on opioid prescriptions. But several public health researchers say that the rise of fentanyls requires different tools. Opioid prescriptions have been falling, even as the death rates from overdoses are rising.”
Prescription opioids are not the cause of the overdose death crisis. Neither is fentanyl, despite the fact that it is now the primary driver of the rising death rate. The ultimate cause of the drug overdose crisis is prohibition. US policymakers should drop the false narrative and face reality, like Portuguese health authorities did 17 years ago.
Portugal, in 2001, recognized that prohibition was driving the death rate. At the time it had the highest overdose rate in Western Europe. It decriminalized all drugs and redirected efforts towards treatment and harm reduction. Portugal saw its population of heroin addicts drop 75 percent, and now has the lowest overdose rate in Europe. It has been so successful that Norway is about to take the same route.
At a minimum, policymakers in the U.S. should turn to harm reduction. They should expand syringe exchange and supervised injection facilities, lighten the regulatory burden on health care practitioners wishing to treat addicts with medication‐assisted treatments such as methadoneand buprenorphine, and reschedule the overdose antidote naloxone to a truly over‐the‐counter drug.
Unless this happens, we should expect more discouraging news from the NCHS in the years ahead.
Speaking last week at a National Opioid Summit in Washington, DC, Attorney General Jeff Sessions reported opioid prescriptions fell another 12 percent during the first eight months of 2018, saying ‘We now have the lowest opioid prescription rates in 18 years.” Some of this was no doubt the result of the chilling effect that prescription surveillance boards have had on the prescribing patterns of physicians. For example, Sessions announced the Trump administration has charged 226 doctors and 221 medical personnel with “opioid‐related crimes,” and this has not gone unnoticed by health care practitioners.
Sessions also pledged to meet the goal of a 44 percent overall reduction in the production of opioids permitted by the Drug Enforcement Administration. The DEA, which sets quotas on the production of opioids by US manufacturers, began the process with a 25 percent reduction in 2016 and another 20 percent reduction in 2017. This has led to shortages of injectable opioids in many hospitals, affecting the delivery and quality of care.
Meanwhile, the DEA reported in a Joint Intelligence Report that overdoses in Pennsylvania continued to rise, with 5,456 fatal overdoses in 2017, a 65 percent increase over 2015. Only 20 percent of those overdoses involved prescription opioids, with most deaths involving multiple drugs in combination—usually fentanyl, heroin and cocaine, as well as counterfeit prescription opioids (usually made of illicit fentanyl and heroin pressed into pills). The report stated heroin and fentanyl were found in 97 percent of Pennsylvania’s counties.
Prescription opioids were also responsible for just 20 percent of the fatal overdoses in Massachusetts in 2015, where researchers at Boston University reported last week in the American Journal of Public Health that Opioid Use Disorder among people over age 11 grew to 4.6 percent of the population that year.
The Massachusetts Department of Public Health reports a modest tapering in the fatal overdose rate, from 2,154 in 2016 to 2,069 in 2017, and estimates up to 1,053 have occurred in the first 6 months of 2018. During the first quarter of 2018, 90 percent of those deaths involved fentanyl, 43 percent involved cocaine, 34 percent involved heroin, and 20 percent involved prescription opioids. Fentanyl is responsible for sustaining the death rate in Massachusetts at near‐record levels.
What jumps out of these numbers is the fact that efforts to get doctors to curtail their treatment of pain have not meaningfully reduced the overdose rate. They have just caused non‐medical users of opioids to migrate over to more dangerous heroin and fentanyl. Fentanyl and heroin—not prescription opioids—are now the principal drugs behind the gruesome mortality statistics.
Addressing the overdose crisis by focusing on doctors treating patients aims at the wrong target. And patients are suffering—often desperately— in the process. The cause has been drug prohibition from the get‐go. If policymakers can’t muster the courage to admit and address that fact, then they should at least put the lion’s share of reform efforts into mitigating the harmful unintended consequences of prohibition. I wrote about this here.
Late last week UPI news ran a report by E.J. Mundell with the headline, “Government efforts to curb opioid prescriptions might have backfired.” It cites two separate studies published online in JAMA Surgery on August 22 that examined two different restrictive opioid policies that fell victim to the Law of Unintended Consequences.
The first study, by researchers at the University of Michigan, evaluated the impact of the Drug Enforcement Administration’s 2014 rescheduling of hydrocodone (Vicodin) from Schedule III to Schedule II. Prescriptions for Schedule III narcotics may be phoned or faxed in by providers, but Schedule II narcotics require the patient to see the prescriber in person in order to obtain a prescription. The DEA’s goal was to reduce the number of Vicodin pills, popular with non-medical users, available for diversion to the black market.
The study looked at 21,955 post-surgical patients across 75 hospitals in Michigan between 2012 and 2015 and found that the number of hydrocodone pills prescribed after the 2014 schedule change increased by an average of seven 5mg tablets. The total Oral Morphine Equivalent of prescribed hydrocodone did not change significantly after the DEA made hydrocodone Schedule II. However, the refill rate decreased after the change. The study’s abstract concluded, “Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery.”
As a practicing general surgeon, my initial reaction to this study was: “Tell me something I don’t know.” Prior to the 2014 schedule change, I would often start off prescribing a small amount of hydrocodone to some of my post-op patients (depending upon the procedure and the patient’s medical history) with the knowledge that I can phone in a refill for those patients who were still in need of it for their pain after the initial supply ran out. Once it was rescheduled, I changed my prescribing habits. Not wanting any of my patients to run out after hours, over a weekend, or on a holiday—when the office is closed and their only recourse would be to go to an emergency room or urgent care center to get a prescription refill—I increased the amount I prescribe (based on my best estimate of the maximum amount of days any individual patient might need hydrocodone) to reduce the chances of them needing a refill. This results in some patients having leftover Vicodin pills in their medicine cabinet. On the other hand, fewer of those patients need refills.
Not surprisingly, many of my clinical peers have done the same thing. It’s not a surprise because most physicians place the interests of their patients ahead of the interests of regulators and bureaucrats. So the adjustment made in postoperative hydrocodone prescribing was basically a “no brainer.”
Earlier this month the Centers for Disease Control and Prevention released preliminary estimates of the opioid overdose rate for 2017. The total overdose rate rose to approximately 72,000, up from a total overdose rate of 63,600 in 2016, an increase of roughly 10 percent. The total overdose rate includes deaths from numerous drugs in addition to opioids, such as cocaine, methamphetamine, and benzodiazepines. The opioid‐related overdose rate increased as well, from a little over 42,000 in 2016 to over 49,000 in 2017. This increase occurred despite a 4 percent drop in heroin overdoses and a 2 percent drop in overdoses due to prescription opioids. A 37 percent increase in illicit fentanyl‐related overdoses explains the jump in the death rate.
All of this is happening while the prescribing of high‐dose opioids continues to decrease dramatically—over 41 percent between 2010 and 2015, with a recent report showing a further decrease of 16 percent during the year 2017.
This is more evidence, if any more was needed, that the opioid overdose problem is the result of non‐medical users accessing drugs in the black market that results from drug prohibition. Whether these users’ drug of choice is OxyContin or heroin, the majority have obtained their drugs through the black market, not from a doctor. A 2007 study by Carise, et al in the American Journal of Psychiatry looked at over 27,000 OxyContin addicts entering rehab between the years 2001 and 2004 and found that 78 percent never obtained a prescription from a doctor but got the drugs through a friend, family member, or a dealer. 86 percent said they took the drug to “get high” or get a “buzz.” 78 percent also had a prior history of treatment for substance abuse disorder. And the National Survey on Drug Use and Health has repeatedly found roughly three‐quarters of non‐medical users get their drugs from dealers, family, or friends as opposed to a doctor.
Media and policymakers can’t disabuse themselves of the false narrative that the opioid problem is the product of doctors hooking their patients on opioids when they treat their pain, despite the large number of studies showing–and the Director of the National Institute on Drug Abuse stating—that opioids used in the medical setting have a very low addiction rate. Therefore, most opioid policy has focused on decreasing the number of pills prescribed. Reducing the number of pills also aims at making less available for “diversion” into the black market. This is making many patients suffer from undertreatment of their pain and causes some, in desperation, to turn to the black market or to suicide.
Since 2010, opioid policy has also promoted the development of abuse‐deterrent formulations of opioids—opioids that cannot be crushed and snorted or dissolved and injected. As a just‐released Cato Research Brief as well as my Policy Analysis from earlier this year have shown, rendering prescription opioids unsuitable for abuse has only served to make non‐medical users migrate over to more dangerous heroin, which is increasingly laced with illicit fentanyl.
This is how things always work with prohibition. Fighting a war on drugs is like playing a game of “Whac‐a‐mole.” The war is never‐ending and the deaths keep mounting.
The so‐called “opioid crisis” has morphed into a “fentanyl and heroin crisis.” But it has been an unintended consequence of prohibition from the get go.