Tag: 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. 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.

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.

While Politicians Cut Opioid Prescriptions, Fentanyl—With Help From the “Dark Web” and the USPS— Becomes the Number One Killer

A May 22 story in Bloomberg News describes with painstaking detail the underground pipeline through which the powerful synthetic opioid fentanyl floods the US market. According to the Drug Enforcement Administration, while the Mexican cartel plays a role by using its well-established heroin and methamphetamine distribution networks, most of the fentanyl comes in to the US from China. 

The raw materials to make the synthetic opioids are cheap and they can be manufactured rather quickly in small laboratories. The laboratories are constantly creating new variations so as to skirt restrictions the Chinese government places on existing fentanyl analogs. Online distributors throughout China sell these products, making their transactions over the “dark web,” often paid with cryptocurrency, and frequently ship the products to the US via the US Postal Service or United Parcel Service. 

Many dealers purchase and use pill presses to make counterfeit OxyContin or Vicodin pills and trick non-medical users into thinking they are buying the real thing. That’s how Prince died. He preferred to abuse Vicodin (hydrocodone). Records show he never got prescriptions from doctors. He died from ingesting counterfeit Vicodin pills he obtained on the black market that turned out to be fentanyl.

The DEA reports this is the way most fentanyl makes its way to the street. As we doctors know, most pharmaceutical-grade fentanyl made for medical use does not get diverted on to the streets. In fact, the forms usually prescribed to outpatients—skin patches, lozenges, buccal films—are not very suitable for non-medical use.

The Centers for Disease Control and Prevention reports that fentanyl was responsible for 26,000 overdose deaths in 2017. But already in 2016 fentanyl accounted for more than 20,000 of the roughly 64,000 total overdose deaths (which include cocaine, methamphetamine, and benzodiazepines). Heroin came in second with more than 15,000. In fact, for a few years now, fentanyl and heroin have accounted for the majority of overdose deaths. And a great majority of those deaths had multiple other drugs on board. In New York City in 2016, three-quarters of overdose deaths were from fentanyl and heroin, and 97 percent of overdoses had multiple other drugs on board—46 percent of the time it was cocaine.

Fentanyl overdoses in the US have been rising at a rate of 88 percent per year since 2013. Heroin overdoses have been increasing at a rate of 19 percent per year since 2014 after climbing 33 percent per year from 2010-2014. Meanwhile, overdose deaths from prescription-type opioids have been increasing at a stable rate of 3 percent per year since 2009.

The National Survey on Drug Use and Health reports non-medical use of prescription opioids peaked in 2012, and total prescription opioid use in 2014 was lower than in 2012. And the survey repeatedly reports less than 25 percent of non-medical users see a doctor in order to get a prescription. Three-quarters obtain their drugs through a friend or family member or a drug dealer.

Meanwhile, while all this is going on, policymakers in Washington and in state capitals seem intent on getting the opioid prescription rate down further. State-based prescription drug monitoring programs have succeeded in reducing the prescription of high-dose opioids by over 41 percent since 2010, the peak year of opioid prescribing. And opioid production quotas, set by the DEA, were reduced 25 percent last year and another 20 percent this year, generating acute shortages of injectables in hospitals across the nation that is harming patients.

With all the evidence that the majority of non-medical users are not patients—with all the evidence that prescription rates have come down while overdose rates keep going up—with all the evidence of fentanyl and heroin flooding the black market and causing those deaths, it is time for policymakers to disabuse themselves of the false narrative to which they’ve been stubbornly clinging. This narrative blames the overdose problem on doctors prescribing pain relievers to their patients. The overdose problem has always been primarily caused by non-medical users accessing drugs in the dangerous black market created by drug prohibition. And our current restrictive policy is only driving up the death rate by pushing these users to more dangerous drugs while making patients suffer in the process.

What’s the definition of insanity?

Is FDA Commissioner Realizing That America’s War on Opioids Has Become a War on Patients?

In a May 14 blog post, Food and Drug Commissioner Scott Gottlieb expressed concern about the effect the nation’s restrictive policy towards the manufacture and prescription of opioids is having on patients with chronic pain conditions. This is one of the first signs that someone in the administration has taken note of the unintended consequences of this misguided policy—a policy that is based upon the false narrative that the overdose crisis is primarily the result of doctors prescribing opioids to patients in pain.

In response to a wide range of public input solicited by the FDA beginning in September 2017, Commissioner Gottlieb stated:

We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life.

Pointing out that, “In some medical circumstances, opioids are the only drugs that work for some patients,” Dr. Gottlieb announced that a public meeting will be held on July 9 on “Patient-Focused Drug Development for Chronic Pain,” and invited pain patients to offer their perspectives.

Hinting at his dissatisfaction with the 2016 one-size-fits-all opioid prescription guidelines published by the Centers for Disease Control and Prevention that have greatly influenced state and federal opioid policymakers, he signaled that the FDA is considering proposing its own set of guidelines. Unlike the CDC guidelines, which are not evidence-based and were never intended to be prescriptive, Gottlieb stated:

In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines.

Opioid prescriptions peaked in 2010, and high-dose opioid prescriptions are down more than 41 percent since then. Yet the overdose rate continues to climb year after year, with fentanyl and heroin being the major culprits while overdoses from prescription type opioids have stabilized and have even slightly receded. The overdose problem was never really primarily caused by doctors treating patients in pain. It has always been principally due to nonmedical users accessing opioids in the illegal market. And as prescription opioids have become less accessible to them, they are migrating over to more dangerous drugs. The present policy towards the problem is making patients suffer while, at the same time, driving up the death rate. 

This is the first indication that a significant member of the Administration might be coming to that realization.

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. Another study last October by a Purdue University researcher found that while PDMPs drove down the prescription rate of oxycodone, they significantly drove up the rate of heroin use.

Yesterday the Annals of Internal Medicine published a systematic research review by Columbia University epidemiologist David Fink and others that drew the same conclusion. The authors stated, “Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs.” They added, “implementation of PDMPs may have unintended negative outcomes—namely, increased rates of heroin-related overdose.”

Meanwhile, all 50 states have implemented PDMPs and state and federal policymakers seem focused on beefing them up. This is driven by the mistaken belief that the opioid overdose rate is primarily the result of doctors over-prescribing opioids to patients. As I have written numerous times, the overdose crisis is primarily a product of drug prohibition, as non-medical users access drugs in the dangerous black market. PDMPs might be responsible for the dramatic drop in the opioid prescription rate these last 8 years (the rate peaked in 2010), but as the prescription rate has dropped the overdose rate has increased—while fentanyl and heroin are now causing these overdoses the majority of the time.

How much more evidence will it take before policymakers finally realize their approach is not evidence-based but is contributing significantly to the overdose crisis?

New York Times Succumbs to The False Narrative Driving Opioid Policy-and Deaths

In an April 21 editorial, the New York Times succumbs to the false narrative reverberating in the media echo chamber that blames the opioid overdose crisis on doctors overprescribing opioids to their patients in pain. Even worse, the Times perpetuates a significant component of that narrative: the myth that such overprescribing can essentially be traced to nothing more than a single letter to the editor by researchers at Boston University in the New England Journal of Medicine in 1980 touting the low addictive potential of opioids when prescribed in the medical setting. 

In fact, numerous studies before and after that now “infamous” letter continue to demonstrate the low addictive potential of medically prescribed opioids. For example, 2010 and 2012 Cochrane systematic analyses show chronic non-cancer pain patients on opioids have a roughly 1 percent addiction rate, and a January 2018 study by researchers at Harvard and Johns Hopkins of more than 568,000 “opioid naïve” patients over 8 years who were given opioids for acute postoperative pain showed a total “misuse” rate of 0.6 percent. In a 2016 New England Journal of Medicine article, Dr. Nora Volkow, the Director of the National Institute on Drug Abuse, stated, “Addiction occurs in only a small percentage of patients exposed to opioids—even those with preexisting vulnerabilities.” Furthermore, researchers at the University of North Carolina followed 2.2 million North Carolina residents prescribed opioids in 2015 and found an overdose rate of just 0.022 percent—and 61 percent of those overdoses involved multiple other drugs.

The Times then offers the same restrictive strategy—only more so— that is doomed to fail because it is based upon a false premise. The editors even suggest that opioids should be restricted to terminal cancer patients. Look at where this approach has gotten us thus far.

The prescription of opioids to patients peaked in 2010, with high-dose prescriptions down 41 percent since that time. A report last week from IQVIA showed opioid prescriptions dropped 10 percent in the last year, and high-dose prescriptions dropped 16 percent. The Drug Enforcement Administration ordered a 25 percent reduction in opioid production in 2017 and another 20 percent reduction this year. And since 2010, OxyContin has only been available in an abuse-deterrent form and many other opioids are likewise being reformulated. 

Yet the overdose rate continues to climb, and the majority of overdoses are due to fentanyl and heroin while the overdose rate from prescription opioids has stabilized or even slightly receded. The great majority of overdoses involve multiple drugs. In New York City in 2016, 75 percent of overdoses were from heroin or fentanyl and 97 percent of overdoses involved multiple drugs—46 percent of the time it was cocaine.

The opioid overdose crisis has always been primarily a manifestation of nonmedical users accessing drugs in a dangerous black market caused by drug prohibition. 

Policymakers must disabuse themselves of the false narrative they continue to embrace. It is the driving force behind a policy that has returned us to the “opioiphobia” of the Nixon era. It is making patients needlessly suffer and increasing the death rate by driving nonmedical users to more dangerous and deadly alternatives.