Tag: Opioids

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.

The Beginning of the End for Cannabis Prohibition?

The Boston Globe reports Colorado Senator Cory Gardner is crafting a bill that would prevent the federal government from interfering with states that have voted to legalize cannabis for recreational or medicinal purposes. The Senator is busy recruiting several co-sponsors for the bill, and he has received assurances from President Trump that he would sign such a bill into law.

This would be a step in the right direction and would alleviate concerns in many states that the Department of Justice, under new guidance from Attorney General Sessions, might enforce federal marijuana prohibition.

Unfortunately, as long as the Drug Enforcement Administration continues to classify cannabis as a Schedule 1 drug, quality clinical research on the potential medical applications of cannabis will remain significantly inhibited. By definition, a Schedule 1 drug has “no currently accepted medical treatment use.” Recent studies have shown that chronic pain patients have been able to reduce their opioid dosage and consumption by adding cannabis to their pain management regimen. A study of Medicare Part D patients from the University of Georgia published in JAMA earlier this month demonstrated this effect in states where medicinal marijuana has been legal. Another study published the same week from the University of Kentucky showed this effect was even greater in states where marijuana is legal for recreational use. And another recent study from the Minnesota Department of Health earlier this year found 63 percent of patients taking medical marijuana for their chronic pain were able to reduce or eliminate their opioid use within 6 months.

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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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From “Opioid Epidemic” to “Stimulant Epidemic”

Speaking at the National Rx Abuse and Heroin Summit in Atlanta, John Eadie, coordinator for the National Threat Initiative, warned, “We’re now facing a very significant stimulant epidemic.” Abuse of prescription stimulants such as Adderal and Ritalin (used to treat Attention Deficit Disorders) as well as illicit stimulants, like cocaine and methamphetamine, are surging. “No one is paying attention to this,” Eadie said, because the focus has been on opioids.

Law enforcement has seized 15 kilograms of stimulants for every kilogram of heroin it has seized during the last 5 years. The Centers for Disease Control and Prevention reports that psychostimulant overdose deaths rose 30 percent in the past year. There is evidence to suggest stimulant abuse is now outpacing opioid abuse. And the Drug Enforcement Administration reports that cocaine use and availability are at their highest level in a decade.

I wrote here about the resurgence of methamphetamine abuse once meth labs, especially in Mexico, found a substitute for Sudafed after the federal and state governments made it more difficult to obtain. And Oregon health authorities reported overdose deaths from heroin dropped in 2016 to 107 while overdose deaths from methamphetamine rose to 141.

There are lessons to be learned from this news if anyone chooses to learn them. The obvious one is that the “War on Drugs,” America’s longest war, is unwinnable. This lesson was apparently not learned when the nation experimented with alcohol prohibition in the early 20thcentury. When a market exists for willing buyers and sellers, prohibition just drives that market underground. Waging a war on drugs is like playing a game of “Whac-a-mole.”

But the other lesson relates to current opioid policy. Policymakers seem stuck in what should, by now, be an obviously false narrative: that the opioid overdose crisis is a product of doctors prescribing opioids to their patients. And even after considerable reductions in the prescribing and manufacturing of opioids for patients has shifted non-medical users over to heroin and fentanyl—now the dominant causes of opioid deaths—policymakers can’t disabuse themselves of this false narrative. They continue to double down on restricting prescriptions of opioids and make many patients suffer in the process. 

The opioid overdose crisis has always primarily been the result of non-medical users seeking opioids in the illicit market—where the dose, purity, and even the actual identity of a substance can never be known with confidence. 

The resurgence of stimulant abuse and overdose should not be viewed in isolation. It should be integrated with the opioid issue. Both should be viewed in the broader context of substance abuse in the presence of drug prohibition. Sociocultural and psychosocial factors may ultimately explain why the use and abuse of mind altering drugs is on the rise across much of the developed world

As long as policymakers continue using supply-side interventions, hoping to win an unwinnable war, the problem will continue to grow.

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Why Doesn’t the Surgeon General Seek FDA Reclassification of Naloxone to OTC?

The Surgeon General issued an “Advisory on Naloxone and Opioid Overdose” today, drawing attention to the effectiveness of the opioid overdose antidote naloxone. The drug, approved for use since 1971, is an effective remedy that can be safely administered by lay personnel who receive basic instructions. The Advisory cites research demonstrating that community-based overdose education and naloxone distribution reduces overdose deaths, and points out that first responders in most states and communities are now equipped with the drug.

Because naloxone is available only by prescription, most states have developed workarounds to make it more available to patients and, in some cases, third parties who have proximity to medical and non-medical opioid users. This way, witnesses to an overdose can be capable of rescuing the victim. This usually involves a state authorizing pharmacists to prescribe the drug or, in many cases, the state health director, acting as the state’s physician, issuing a “standing order” to pharmacists to distribute it.

The Advisory lists a number of conditions and situations that might place a person at risk of opioid overdose and encourages such people, or people who know them, to avail themselves of naloxone. It supports efforts at wider distribution at the community level.

Unfortunately, because of the stigma that has developed in association with opioid use, many opioid patients are reluctant to speak to the pharmacist and request a naloxone prescription. In some states, the naloxone will not be prescribed to third parties who know an opioid user. Also, numerous instances have been reported where pharmacists are reluctant to prescribe the antidote, believing they are “enabling” a drug abuser.

Recognizing this obstacle to naloxone distribution, Australia made it available over-the-counter in 2016, making it as easy to purchase as cold remedies or antacids. This way medical and nonmedical opioid users can discreetly make a purchase and check out at the cash register without having to answer any questions or face scrutiny from a pharmacist. The drug has been over-the-counter in Italy for over 20 years.

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People Who Have Never Experienced Back Pain Have No Business Making Opioid Policy

Economist Steven Horwitz writes in USA Today about President Trump’s proposal to reduce legal opioid prescriptions by one third. Such a drastic reduction would inevitably harm people like Horwitz, who relates his experience with excruciating back pain and how opioids were essential to relieving his agony and helping his body heal:

People who wish to drastically limit access to opioids need to know the reality of this kind of pain. Getting out of bed took 10 minutes or more because even one small wrong movement while getting to a sitting position would cause severe back spasms, making me shudder with pain. Walking around my house required balancing myself on walls and door frames.

The pain from sitting down and standing up from the toilet required that I use a chair to hold my weight like one would use a walker. I had visions of being found in the bathroom, stuck on the toilet or even unable to get up off of the floor. Every little twist and turn of my body risked those spasms and shuddering.

Eventually I realized my mistake and got a prescription for opioids. The quality of my life quickly and dramatically improved, as within two or three days, the pain was reduced substantially and my mobility and mood were significantly better. I could walk comfortably and hug my kids again.

It’s important to understand that this kind of debilitating pain not only causes unnecessary suffering, it prevents patients from healing. It takes every bit of energy you have to fight it, and your body has little to nothing left to use to heal. Some medical professionals call pain “the fifth vital sign” because of the way in which it matters for a patient’s health. Opioids enabled me to relax, to sleep and to heal.

I too am one of the people Trump’s policy might harm.

I suffer from episodic back pain. Everything Horwitz describes I have experienced. If anything, I would say he understates the agony. In my experience, the pain can be more like torture—as if someone were deliberately trying to inflict as much pain as possible, for the purpose of breaking me emotionally and leaving me trembling in fear of its return.

Like Horwitz, I did not want to treat my back pain with opioids. I had previously used them to recover from knee surgery and I disliked the experience so much that after my second knee surgery, I refused them. Like Horwitz, I feared addiction. So I tried stretching. I tried physical therapy. I tried non-prescription analgesics.

Nothing worked until I broke down—until the pain broke me—and I tried opioids. They worked. They eliminated my pain and, as Horwitz says, that allowed me to heal. My pain could come back at any time, and so I too could be one of the people Trump’s policy would leave to suffer in excruciating pain. 

People who have never experienced back pain have no business making opioid policy.

Multiple Distinguished Health Care Practitioners Speak Out Against Misguided Opioid Policy

On March 30, Sally Satel, a psychiatrist specializing in substance abuse at Yale University School of Medicine, co-authored an article with addiction medicine specialist Stefan Kertesz of the University of Alabama Birmingham School of Medicine condemning the plans of the Center for Medicare and Medicaid Services to place limits on the amount of opioids Medicare patients can receive. The agency will decide in April if it will limit the number of opioids it will cover to 90 morphine milligram equivalents (MME) per day. Any opioids beyond that amount will not be paid for by Medicare. One year earlier, Dr. Kertesz made similar condemnations in a column for The Hill. While 90 MME is considered a high dose, they point out that many patients with chronic severe pain have required such doses or higher for prolonged periods of time to control their pain. Promoting the rapid reduction of opioid doses in such people will return many to a life of anguish and desperation.

CMS’s plan to limit opioid prescriptions mimics similar limitations put into effect in more than half of the states and is not evidence-based. These restrictions are rooted in the false narrative that the opioid overdose problem is mostly the result of doctors over-prescribing opioids to patients in pain, even though it is primarily the result of non-medical opioid users accessing drugs in the illicit market. Policymakers are implementing these restrictions based upon a flawed interpretation of opioid prescribing guidelines published by the Centers for Disease Control and Prevention in 2016.

Drs. Satel and Kertesz point out that research has yet to show a distinct correlation between the overdose rate and the dosages on which patients are maintained, and that the data show a majority of overdoses involve multiple drugs. (2016 data from New York City show 97 percent involved multiple drugs, and 46 percent of the time one of them was cocaine.)

Not only are the Medicare opioid reduction proposals without scientific foundation, but they run counter to the recommendations of CMS in its 2016 guidelines. As Dr. Kertesz stated in 2017:

“In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.”

In an effort to dissuade the agency, Dr. Kertesz sent a letter to CMS in early March signed by 220 health professionals, including eight who had official roles in formulating the 2016 CDC guidelines. The letter called attention to the flaws in the proposal and to its great potential to cause unintentional harm. CMS will render its verdict as early as today.

Until policymakers cast off their misguided notions about the forces behind the overdose crisis, patients will suffer needlessly and overdose rates will continue to climb. 

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