Heroin

For Those Who Are Serious About Increasing Access to MAT for Opioid Use Disorder…

The synthetic opioid methadone, developed in Germany in the 1930s for the treatment of severe pain, has been employed for the Medication Assisted Treatment (MAT) of heroin addiction and opioid use disorder since the 1960s. In the US, methadone clinics are tightly regulated by the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration. 

Patients receiving methadone to treat their addiction must ingest it under the observation and supervision of clinic staff, who keep it in a lock box. Eventually, patients are permitted to take a few doses home with them for use over the weekend, and only after a lengthy course are some patients allowed to take home doses for themselves for “maintenance” purposes.

Individual states add additional layers of regulation. West Virginia has had a statewide moratorium on new methadone clinics since 2007. Georgia, Indiana, Louisiana, Mississippi, and Wyoming have onerous restrictions and caps on their growth. Ohio recently lifted its moratorium on privately-owned methadone clinics. 

All of this makes it very difficult for health care practitioners who wish to treat patients with substance abuse disorder to do so using methadone. Despite these obstacles, the DEA reports it approved 254 new methadone clinics between 2014 and 2018 in response to the opioid overdose crisis. But the demand for methadone clinics far exceeds the supply. And it is unrealistic to expect people seeking treatment who live in rural areas or in states where methadone clinics are few and far between to drive long distances to and from the nearest clinic to take their daily dose. 

Contrast this with MAT using buprenorphine (Suboxone). This partial opioid agonist was approved by the Food and Drug Administration for MAT in 2002 and was combined with the overdose antidote naloxone into its abuse-deterrent formulation, Suboxone, in 2010. Under the Drug Addiction and Treatment Act (DATA) passed in 2000, doctors were permitted to prescribe buprenorphine on an ambulatory basis after taking an 8-hour course and meeting other requirements administered by SAMHSA. There are strict limits on the number of patients a practitioner may treat, and nurse practitioners and physician assistants need to obtain a waiver in order to prescribe Suboxone.  Congress passed the SUPPORT for Patients and Communities Act last October, raising the quota on the number of patients a doctor can treat while expanding the role of nurse practitioners and physician assistants. These regulations still deter many practitioners from providing MAT to their patients. SAMHSA reports that as of this date only 8 percent of practitioners have sought certification for buprenorphine treatment. Yet as onerous as these regulations may be, they are not nearly as onerous as those that govern methadone treatment.

Add Hepatitis C to the List of Unintended Consequences of Abuse-Deterrent Opioids

One year ago Cato published my policy analysis, “Abuse-Deterrent Opioids and the Law of Unintended Consequences,” which provided strong evidence that reformulating opioids, so that they could not be crushed for snorting or dissolved for injecting by nonmedical users, only served to drive nonmedical users to more dangerous, readily available, and cheaper heroin provided by the efficient black market. 

Latest Numbers From Massachusetts Provide More Evidence That Prohibition Is The True Killer

The Massachusetts Department of Public Health reported today on the opioid-related overdose rate in the commonwealth for 2017. The good news is the overdose death rate decreased by 8 percent from 2016 to 2017. 

But a closer look at the numbers reveals that overdoses from prescription opioids were found in around 20 percent of “opioid deaths with specific drugs present.” (See figure 4, page 3 of the report.)

Today’s Drug Abusers Did Not Derive From Yesterday’s Patients

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.

Prohibition Is the Obvious Cause of Opioid Crisis as CDC Releases Preliminary Casualty Numbers for 2017

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.

Civilian Casualties Continue to Mount in Governments’ War on Opioids

I have written here and here about how patients have become the civilian casualties of the misguided policies addressing the opioid (now predominantly fentanyl and heroin) crisis. The policies have dramatically reduced opioid prescribing by health care practitioners and have pressured them into rapidly tapering or cutting off their chronic pain patients from the opioids that have allowed them to function. More and more reports appear in the press about patients becoming desperate because their doctors, often fearing they may lose their livelihoods if they are seen as “outliers” by surveillance agencies, under-treat their pain or abruptly cut them off of their pain treatment regimen.

story in the July 23, Louisville (KY) Courier Journal illustrates the harm this is causing in Kentucky. “Doctors say the federal raids on medical clinics lead to unintended consequences — patients thrust into painful withdrawals and left vulnerable to suicide or dangerous street drugs,” states the article.  Dr. Wayne Tuckerson, President of the Greater Louisville Medical Society, said, “[When investigators] go in with a sledgehammer and shut down a practice without consulting community physicians, suddenly we have patients thrown loose.” He went on to say, “Docs are very much afraid when it comes to writing pain medications…We don’t want patients to become addicted. And we don’t want to have our licenses — and therefore our livelihoods — at stake.” And if pharmacists in the area learn of a police raid or investigation of a medical practice—regardless of the outcome of that investigation—many of them refuse to fill legal prescriptions presented by patients of those practitioners.

Last week Oregon regulators announced plans for a “forced taper” of chronic pain patients in its Medicaid system. This contradicts and is much more draconian than the recommendations of the 2016 guidelines issued by the Centers for Disease Control and Prevention, which in turn have been criticized as not evidence-based. The Oregon Health Evidence Review Commission announced: 

 

The changes include a forced taper for all chronic pain patients on opioids (within a year), no exceptions. Opioids will be replaced with alternative treatments (cognitive behavior therapy (CBT), acupuncture, mindfulness, pain acceptance, aqua therapy, chiropractic adjustments, and treatment with non-opioid medications, such as NSAIDS, Acetaminophen).

 

This proposal has sparked an outcry from patients and patient advocacy groups in Oregon. While this policy proposal only applies to Medicaid patients, they fear it will soon become the standard adopted by all third-party payers in the state.

University of Alabama Medical School Associate Professor Stefan Kertesz, an addiction medicine specialist at the Birmingham VA Medical Center, tweeted in reaction to this proposal:

 

I cannot imagine a more violent rejection of the CDC Guideline on Prescribing Opioids of 2016 than the plan current before Oregon Medicaid : forced taper to 0 mg of all opioid receiving pain patients.

 

FDA Commissioner Gottlieb’s Sunday “Tweetorial” Is Both Encouraging and Frustrating

A fair reading of Food and Drug Administration Commissioner Scott Gottlieb’s “Sunday Tweetorial” on the opioid overdose crisis leaves one simultaneously encouraged and frustrated. 

First the encouraging news. The Commissioner admits that the so-called epidemic of opioid overdoses has “evolved” from one “mostly involving [diverted] prescription drugs to one that’s increasingly fueled by illicit substances being purchased online or off the street.” Most encouraging was this passage:

Even as lawful prescribing of opioids is declining, we’re seeing large increases in deaths from accidental drug overdoses as people turn to dangerous street drugs like heroin and synthetic opioids like fentanyl. Illegal online pharmacies, drug dealers and other bad actors are increasingly using the Internet to further their illicit distribution of opioids, where their risk of detection and the likelihood of repercussions are seen by criminals as significantly reduced.

As I have written here and here, the overdose crisis has always been primarily caused by non-medical users accessing drugs in a dangerous black market fueled by drug prohibition. As government interventions have made it more expensive and difficult to obtain diverted prescription opioids for non-medical use, the black market responds efficiently by filling the void with heroin, illicit fentanyl (there is a difference) and fentanyl analogs. So policies aimed at curtailing doctors’ prescriptions of opioids to patients only serve to drive up deaths from these more dangerous substitutes, while causing patients to suffer needlessly, sometimes desperately, in pain. Gottlieb validates my argument in his “tweetorial,” providing data from the Centers for Disease Control and Prevention and the Drug Enforcement Administration.

Now for the frustrating news. Gottlieb next reminds us, “No controlled substances, including opioids, can be lawfully sold or offered to be sold online. There is no gray area here.” He provides evidence of rampant illegal internet marketing of prescription opioids, with 95 percent of internet pharmacy websites selling opioids without a prescription, often conducting transactions with cryptocurrencies, and shipping these orders “virtually anywhere in the US.” This is also the way illicit fentanyl is flooding the market.

New Research Reinforces Earlier Studies Suggesting PDMPs Are Adding to Opioid Overdose Rate

study published last year by researchers at the University of Pennsylvania and Pennsylvania State University found that state Prescription Drug Monitoring Programs (PDMPs), a popular method used to drive down the opioid prescription rate, do not drive down opioid overdose death rates, but might have the unintended consequence of adding to them, by driving users to the underground market where dangerous drugs like fentanyl and heroin await them.

Subscribe to RSS - Heroin