Tag: Opioids

Why Is the OECD Trying to Connect Labor Market Conditions and Opioids?

story in today’s Wall Street Journal discusses the latest report from the Organization for Economic Cooperation and Development on ”prime age” (25-54) labor-force participation rates among its 35 member countries through the last quarter of 2017. While the US rate has improved, it remains below the average OECD rate, lagging behind such developed countries as Japan and the UK. What’s puzzling is why the authors of the report decided to weigh in on the opioid overdose issue.

Noting that per capita opioid prescriptions in the US are “significantly higher” than in other OECD countries, the report finds that participation rates for all adults (not limited to prime age) vary from state to state. The rate was lowest in West Virginia at 53 percent, and highest in North Dakota at 71 percent. It mentioned that opioid prescription rates are “generally higher” in those states with lower labor participation rates, leading it to declare that the use of opioid drugs “appears to be connected” to labor market conditions.

The number of opioid prescriptions has been dropping steadily in the US since it peaked in 2010. In fact, high-dose opioid prescriptions are down over 41 percent. An April 2018 report from the American Medical Association trumpeted a 22 percent decrease in opioid prescriptions between 2013 and 2017. 

The false narrative dominating the media and driving opioid policy blames opioid abuse and overdoses on doctors addicting their patients to pain pills. The near quadrupling of the sales of prescription opioids between 1999 and 2014 is often used to help make the case. 

Yet correlation does not imply causation. The AMA made note of this in its April report on the dramatic drop in prescriptions when it stated:

It is notable that every state has experienced a decrease, but this is tempered by the fact that deaths related to heroin and illicit fentanyl are increasing at a staggering rate, and deaths related to prescription opioids also continue to rise. These statistics again prove that simply decreasing prescription opioid supplies will not end the epidemic.

Data from the Centers for Disease Control and Prevention show that overdoses—especially from fentanyl and heroin—continue to soar as prescription rates decline on the state level as well. 

The principle that correlation does not imply causation also applies to the observations in the OECD report.

The OECD report mentions that the overall labor-force participation rate tends to be lower in states where disability rates are higher. And West Virginia is a leader among states with respect to the percentage of its population on Social Security Disability benefits at 3.9 percent. It therefore points to a “possible connection between drug use and disability,” adding “addiction ultimately impairs participation.” It is certainly reasonable to expect that patients disabled by chronic severe pain conditions will be prescribed opioids. But there is no evidence that opioid use increases disability rates. In fact, Cochrane systematic studies in 2010 and 2012 found an addiction rate of approximately 1 percent in chronic non-cancer pain patients on long-term opioids. And many chronic pain patients are gainfully employed but have to stop working when they are cut-off from their opioids and their pain becomes debilitating. 

As I have written here and here, the overdose crisis was never about doctors and patients. It has always been primarily the result of non-medical users accessing drugs in the dangerous black market that results from drug prohibition.

Because correlation does not imply causation the OECD report carefully avoids drawing conclusions by using phrases like “appears to be connected” and “generally higher.” But its allusion to a connection between opioid prescribing and the labor participation rate is intellectually irresponsible and seems a gratuitous attempt to patronize the opioid policy establishment.

The AMA Gets it Right by Defending Evidence-Based Medicine and Patient, Physician Autonomy

Gun control advocates like to accuse legislators of being “afraid of the NRA,” implying that reason and principle have nothing to do with their legislative decisions. In the same way, Jackie Kucinich, in a column in The Daily Beast, suggests that the failure of Congress to pass CARA 2.0 (Comprehensive Addiction and Recovery Act) is due primarily to the lobbying clout of the American Medical Association, pointing to its status as the “seventh highest lobbying spender in 2017.”  

The article quotes opioid reform advocate Gary Mendell as saying “the AMA will resist anything that regulates healthcare”—an interesting opinion about an organization that supported passage of the Affordable Care Act, one of the deepest regulatory intrusions into American health care in half a century. Over the years, the AMA’s seeming reluctance to mount a principled defense of patient autonomy and freedom of choice in healthcare—perhaps fearing it may jeopardize the cartel it lobbied so hard to establish over the past century and a half—has led to an exodus of many disillusioned members. It is estimated that less than 17 percent of the country’s doctors belong to the special interest group today.

But on this one, the AMA gets it right. It opposes the “one-size-fits-all” imposition of the 2016 opioid prescribing guidelines issued by the Centers for Disease Control and Prevention; guidelines that many noted addiction medicine specialists have criticized as not-evidence based. The AMA maintains the CDC expressly meant for its guidelines to be suggestive “rather than prescriptive.” Other scholars have pointed out that the CDC’s suggestions were based upon “Type 4 evidence,” defined as evidence in which “one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.”  The AMA emphasizes the guideline’s statement, “Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning and life context.”

When health care providers read and interpret these guidelines, they understand them to be informational, nonbinding, and inconclusive. But that’s not how politicians “do science.”

There is no evidence that prescription limits reduce overdose deaths. In fact, as the prescription rate has dropped dramatically since its peak in 2010, overdose rates are in turn rising

Kucinich seems to agree with the politicians who interpret the CDC guidelines as implying that a more than 3-day supply of prescription opioids is a major force behind addiction. But that is not a precise and critical reading of the guidelines. In fact, as Dr. Nora Volkow, Director of the National Institute on Drug Abuse pointed out in a 2016 New England Journal of Medicine article, “Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities.” Cochrane systematic studies in 2010 and 2012 show a roughly 1 percent incidence of addiction in chronic non-cancer pain patients, and a January 2018 study of 568,000 “opioid naïve” patients given prescriptions for acute post-surgical pain found a “total misuse” rate of 0.6 percent. 

The AMA is actually a little late to the party. Numerous other specialists in the management of pain and addiction have criticized for months the tendency of politicians to codify the recommendations of the CDC. Even the Food and Drug Administration Commissioner, Scott Gottlieb, has expressed concerns. Announcing plans to hold a public meeting on July 9 on “Patient-Focused Drug Development for Chronic Pain,” Dr. Gottlieb set forth “the goal of providing standards that could inform the development of evidence based guidelines.”  

The article quotes Sen. Joe Manchin (D-WV) accusing his colleagues of being “too scared to take on the AMA.” My hope is that they may be finally responding to evidence and accounts from health care practitioners and patients who have spent months appealing to reason over dogma.

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.

 

 

 

Attorney General Sessions Proposes An Even More Destructive Opioid Policy

Speaking to a group of law enforcement officials in Raleigh, NC yesterday, Attorney General Jeff Sessions announced proposed rule changes to the way the Drug Enforcement Administration sets quotas on the manufacturing of opioids. The DEA now presumes to be able to divine the likelihood a particular type of prescription opioid will be diverted to the illegal market when setting production quotas. 

The Attorney General said, “Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make.”

The DEA ordered a 25 percent reduction in opioid production in 2017 and another 20 percent reduction for 2018. The tight quotas on opioid production contributed to the acute shortage of injectable opioids being felt in hospitals across the nation. It is not only making patients suffer needlessly but places them at increased risk for adverse drug reactions or overdose. Just the other day, after pleas from numerous medical professional associations, with the shortage reaching crisis levels, the DEA announced it will begin to relax this year’s quotas. But it may take months before things improve. 

The damage to hospitalized patients is an unintended consequence of central planning and should come as no surprise. DEA administrators had the fatal conceit of believing they could determine just how many opioids should be produced for what they call the “legitimate” pain control needs of the nation’s patients. Yet even after the DEA recognized that the quotas caused harm, with these new proposed regulations they are determined to get back up in the saddle and ride that horse again.

Despite the reduction in opioid supply and a 41 percent reduction in the prescription of high-dose opioids by health care practitioners since 2010—the year prescribing peaked—the overdose rate continues to soar, having increased 20 percent from 2015 to 2016. According to the National Survey on Drug Use and Health, nonmedical use of prescription opioids peaked in 2012, and total prescription opioid use in 2014 was less than in 2012. The evidence is that nonmedical users migrate to cheaper and easier to obtain heroin and fentanyl when diverted prescription opioids become less available. The overdose rate from fentanyl has increased at a clip of 88 percent per year since 2013, and the overdose rate from heroin increased 19 percent per year for the past 2 years after increasing at a rate of 33 percent per year from 2010-2014. Meanwhile, the overdose rate increase for prescription opioids has been unchanged at 3 percent per year since 2009.

The Attorney General and the DEA administrators seem unable to learn from their mistakes. They continue to view the opioid overdose crisis as a product of the number of pills produced or prescribed. They have been wrong about this from the get-go. It has always been the result of nonmedical users accessing drugs in a black market fueled by drug prohibition. The underground market responds quickly. It provides nonmedical users with cheaper and more dangerous and deadly drugs in response to prescription opioid restrictions. 

Not content with the damage they have already caused, regulators appear ready to double down on the supply-side approach to the overdose crisis. This means America’s hospitals can look forward to more and possibly greater shortages of vitally needed opioids, while first responders swell their emergency rooms with ever growing numbers of heroin and fentanyl overdoses.

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