Tag: Heroin

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.

New Study from American Action Forum Adds to the Argument Against Present Supply-Side Opioid Policy

On April 11 the Washington Post cited a new study from the American Action Forum that reinforces arguments I have made here and here, that despite a dramatic reduction in the opioid prescription rate—a 41 percent reduction in high-dose opioid prescriptions since prescriptions peaked in 2010—the overdose rate continues to climb, as nonmedical users have simply migrated to more dangerous substitutes like fentanyl and heroin while the supply of diverted prescription opioids suitable for abuse continues to come down.

I have a minor quibble with the study’s finding that “the annual growth rate of prescription opioid-involved overdose fatalities significantly slowed from 13.4 percent before 2010 to just 4.8 percent after.” In fact, the Center for Disease Control and Prevention end-of-2017 Data Brief No. 294 reported:

The rate of drug overdose deaths involving natural and semisynthetic opioids, which include drugs such as oxycodone and hydrocodone, increased from 1.0 [per 100,000] in 1999 to 4.4 in 2016. The rated increased on average by 13% per year from 1999-2009 and by 3% per year from 2009-2016. (Emphasis added)

As an aside, it is worth mentioning that four researchers working in the CDC’s Division of Unintentional Injury Prevention reported in the April 2018 American Journal of Public Health that the CDC’s method for tracking opioid overdose deaths have over-estimated the number due to prescription opioids, calling the rate “significantly inflated.” Many overdose deaths actually due to fentanyl are folded into the “prescription opioid” numbers since, technically, fentanyl is a prescription drug even though it is rarely prescribed outside of the hospital in a form suitable for abuse. 

The AAF report understates the significant role that the abuse-deterrent reformulation of OxyContin and other opioids have played in driving nonmedical users to heroin and fentanyl. The researchers “suggest” abuse-deterrent formulations “could be a major factor driving the rise in heroin fatalities.” But evidence of the connection is much more powerful and convincing, as I presented in the Cato Policy Analysis “Abuse-Deterrent Opioids and the Law of Unintended Consequences” in February of this year.

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Making the Case, Once Again, That the Opioid Crisis Is a Product of Drug Prohibition, Not Doctors Prescribing to Patients

Martha Bebinger reports for National Public Radio station WBUR about the rise in fentanyl-laced cocaine. She cites numerous accounts of college students using cocaine to stay awake while studying for exams, or while attending campus parties, and then falling into a deep sleep after the initial cocaine rush. Some don’t wake up. Others get revived by the opioid overdose antidote naloxone.

Massachusetts state police recorded a nearly three-fold increase in seizures of cocaine laced with fentanyl over the past year. And the Drug Enforcement Administration lists Massachusetts among the top three states in the US for seizures of cocaine/fentanyl combinations. The DEA says the mixture is popularly used for “speedballing.” The original recipe used heroin mixed with cocaine in order to minimize the negative effects of the “come-down” after the rush of cocaine. Cocaine mixed with heroin is very unpredictable and dangerous. When it is mixed with fentanyl—five times the potency of heroin—it is even more dangerous.

There is a debate among law enforcement as to whether the cocaine is accidentally laced with fentanyl by sloppy underground drug manufacturers, or whether the mixture is intentional. There have been several reports of cocaine users who were unaware that the cocaine they were snorting or smoking contained fentanyl.

Connecticut state health statisticians keep track of opioid overdoses that included cocaine. While the majority of the time the overdose is from the classic “speedball” combination of heroin and cocaine, they have noted a 420 percent increase in fentanyl/cocaine in the last 3 years. However, Massachusetts does not register drug combinations when it records “opioid overdoses,” so it is unknown just what percentage of the 1,977 estimated opioid overdose deaths in Massachusetts last year were in combination with cocaine or other drugs. New York City keeps detailed statistics. In 2016, cocaine was found in 46 percent of the city’s opioid deaths, heroin and fentanyl were involved in 72 percent of opioid overdose deaths, and 97 percent of all opioid overdose deaths involved multiple drugs.

Meanwhile, President Trump and most state and local policymakers remain stuck on the misguided notion that the way to stem the overdose rate is to clamp down on the number and dose of opioids that doctors can prescribe to their patients in pain, and to curtail opioid production by the nation’s pharmaceutical manufacturers. And while patients are made to suffer needlessly as doctors, fearing a visit from a DEA agent, are cutting them off from relief, the overdose rate continues to climb.

The overdose crisis has always primarily been a product of drug prohibition—not of doctors treating patients.

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Hospitalized Patients Are Civilian Casualties in the Government’s War on Opioids

A recent story by Pauline Bartolone in the Los Angeles Times draws attention to some under-reported civilian casualties in the government’s war on opioids: hospitalized patients in severe pain, in need of painkillers. Hospitals across the country are facing shortages of injectable morphine, fentanyl, and Dilaudid (hydromorphone). As a result, trauma patients, post-surgical patients, and hospitalized cancer patients frequently go undertreated for excruciating pain.

Hospitals, including the ones in which I practice general surgery, are working hard to ameliorate the situation by asking medical staff to use prescription opioid pills such as oxycodone and OxyContin instead of injectables, when possible. But many patients are unable to take oral medication due to their acute illness or post-operative condition. In those cases, we are often asked to use injectable acetaminophen, muscle relaxants, or non-steroidal anti-inflammatory agents. But many times those drugs fail to give adequate relief to these patients—which is why they are not the first line of drugs we use.

The shortage is uneven across the country. Some hospitals are feeling the shortage worse than others. According to the American Society of Anesthesiologists, the shortage is so severe in some hospitals that elective surgeries—such as gallbladder and hernia operations—have been postponed.

Some hospitals have resorted to asking nursing staff to manually combine smaller-dose vials of morphine or other injectable opioids that remain in-stock as a replacement for the out-of-stock larger dose vials. Dose-equivalents of different IV opioids vary and are difficult to accurately calculate. This increases the risk of human error and places patients at risk for overdose, as was explained in a letter to the U.S. Drug Enforcement Administration by representatives of the American Hospital Association, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices. The letter asked the DEA to adjust its quota on the manufacture of opioids to help mitigate the shortage.

As part of the effort to address the opioid overdose crisis—which is really a fentanyl and heroin overdose crisis—the DEA, which sets national manufacturing quotas for opioids, ordered a 25 percent reduction in 2017 and another 20 percent reduction this year.

National shortages of drugs are not confined to injectable opioids. Over the years, various drugs in common use have gone on national “back-order” and health care practitioners have had to develop workarounds. The causes of these recurring shortages, not unique to the US, are complex and multifactorial.

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