Tag: Opioids

Addiction Abuse

Hardly a day goes by without a report in the press about some new addiction. There are warnings about addiction to coffee. Popular psychology publications talk of “extreme sports addiction.” Some news reports even alert us to the perils of chocolate addiction. One gets the impression that life is awash in threats of addiction. People tend to equate the word “addiction” with “abuse.” Ironically, “addiction” is a subject of abuse.

The American Society of Addiction Medicine defines addiction as a “chronic disease of brain reward, motivation, memory and related circuitry…characterized by the inability to consistently abstain, impairment in behavioral control, craving” that continues despite resulting destruction of relationships, economic conditions, and health. A major feature is compulsiveness. Addiction has a biopsychosocial basis with a genetic predisposition and involves neurotransmitters and interactions within reward centers of the brain. This compusliveness is why alcoholics or other drug addicts will return to their substance of abuse even after they have been “detoxed” and despite the fact that they know it will further damage their lives. 

Addiction is not the same as dependence. Yet politicians and many in the media use the two words interchangeably. Physical dependence represents an adaptation to the drug such that abrupt cessation or tapering off too rapidly can precipitate a withdrawal syndrome, which in some cases can be life-threatening. Physical dependence is seen with many categories of drugs besides drugs commonly abused. It is seen for example with many antidepressants, such as fluoxetine (Prozac) and sertraline (Zoloft), and with beta blockers like atenolol and propranolol, used to treat a variety of conditions including hypertension and migraines. Once a patient is properly tapered off of the drug on which they have become physically dependent, they do not feel a craving or compulsion to return to the drug.

Some also confuse tolerance with addiction. Similar to dependency, tolerance is another example of physical adaptation. Tolerance refers to the decrease in one or more effects a drug has on a person after repeated exposure, requiring increases in the dose.

Science journalist Maia Szalavitz, writing in the Columbia Journalism Review, ably details how journalists perpetuate this lack of understanding and fuel misguided opioid policies.

Many in the media share responsibility for the mistaken belief that prescription opioids rapidly and readily addict patients—despite the fact that Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse point out addiction is very uncommon, “even among those with preexisting vulnerabilities.” Cochrane systematic studies in 2010 and 2012 of chronic pain patients found addiction rates in the 1 percent range, and a report on over 568,000 patients in the Aetna database who were prescribed opioids for acute postoperative pain between 2008 and 2016 found a total “misuse” rate of 0.6 percent. 

Equating dependency with addiction caused lawmakers to impose opioid prescription limits that are not evidence-based, and is making patients suffer needlessly after being tapered too abruptly or cut off entirely from their pain medicine. Many, in desperation, seek relief in the black market where they get exposed to heroin and fentanyl. Some resort to suicide. There have been enough reports of suicides that the US Senate is poised to vote on opioid legislation that “would require HHS and the Department of Justice to conduct a study on the effect that federal and state opioid prescribing limits have had on patients — and specifically whether such limits are associated with higher suicide rate.” And complaints about the lack of evidence behind present prescribing policy led Food and Drug Administration Commissioner Scott Gottlieb to announce plans last month for the FDA to develop its own set of evidence-based guidelines.

Now there is talk in media and political circles about the threats of “social media addiction.” But there is not enough evidence to conclude that spending extreme amounts of time on the internet and with social media is an addictive disorder. One of the leading researchers on the subject stresses that most reports on the phenomenon are anecdotal and peer-reviewed scientific research is scarce. A recent Pew study found the majority of social media users would not find it difficult to give it up. The American Psychiatric Association does not consider social media addiction or “internet addiction” a disorder and does not include it in its Diagnostic and Statistical Manual of Mental Disorders (DSM), considering it an area that requires further research.

This doesn’t stop pundits from warning us about the dangers of social media addiction. Some warnings might be politically motivated. Recent reports suggest Congress might soon get into the act. If that happens, it can threaten freedom of speech and freedom of the press. It can also generate biliions of dollars in government spending on social media addiction treatment.

Before people see more of their rights infringed or are otherwise harmed by unintended consequences, it would do us all a great deal of good to be more accurate and precise in our terminology. It would also help if lawmakers learned more about the matters on which they create policy.

The Law of Unintended Consequences Strikes Again

Late last week UPI news ran a report by E.J. Mundell with the headline, “Government efforts to curb opioid prescriptions might have backfired.” It cites two separate studies published online in JAMA Surgery on August 22 that examined two different restrictive opioid policies that fell victim to the Law of Unintended Consequences.

The first study, by researchers at the University of Michigan, evaluated the impact of the Drug Enforcement Administration’s 2014 rescheduling of hydrocodone (Vicodin) from Schedule III to Schedule II. Prescriptions for Schedule III narcotics may be phoned or faxed in by providers, but Schedule II narcotics require the patient to see the prescriber in person in order to obtain a prescription. The DEA’s goal was to reduce the number of Vicodin pills, popular with non-medical users, available for diversion to the black market.

The study looked at 21,955 post-surgical patients across 75 hospitals in Michigan between 2012 and 2015 and found that the number of hydrocodone pills prescribed after the 2014 schedule change increased by an average of seven 5mg tablets. The total Oral Morphine Equivalent of prescribed hydrocodone did not change significantly after the DEA made hydrocodone Schedule II. However, the refill rate decreased after the change. The study’s abstract concluded, “Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery.”

As a practicing general surgeon, my initial reaction to this study was: “Tell me something I don’t know.” Prior to the 2014 schedule change, I would often start off prescribing a small amount of hydrocodone to some of my post-op patients (depending upon the procedure and the patient’s medical history) with the knowledge that I can phone in a refill for those patients who were still in need of it for their pain after the initial supply ran out. Once it was rescheduled, I changed my prescribing habits. Not wanting any of my patients to run out after hours, over a weekend, or on a holiday—when the office is closed and their only recourse would be to go to an emergency room or urgent care center to get a prescription refill—I increased the amount I prescribe (based on my best estimate of the maximum amount of days any individual patient might need hydrocodone) to reduce the chances of them needing a refill. This results in some patients having leftover Vicodin pills in their medicine cabinet. On the other hand, fewer of those patients need refills.

Not surprisingly, many of my clinical peers have done the same thing. It’s not a surprise because most physicians place the interests of their patients ahead of the interests of regulators and bureaucrats. So the adjustment made in postoperative hydrocodone prescribing was basically a “no brainer.” 

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.

There Is More Than One Way to “Spin” a Stat

I recently wrote about how ideology and confirmation bias has infiltrated research into the opioid overdose issue. I spoke about how researchers can “spin” their findings to comport with the prevailing narrative and improve the likelihood of getting published in peer-reviewed journals.

An example occurred yesterday, when the University of Michigan’s Institute for Healthcare Policy and Innovation announced, with the headline “Unwise opioids for wisdom teeth: Study shows link to long-term use in teens and young adults,” the publication of a research letter in JAMA that day by a team of its researchers.

The study of over 70,000 dental patients, ranging from 13 to 30 years in age, who had wisdom teeth extracted between 2009 and 2015 found, 

In all, 1.3 percent of 56,686 wisdom tooth patients who filled their opioid prescription between 2009 and 2015 went on to persistent opioid use, defined as two or more prescriptions filled in the next year written by any provider for any reason. That’s compared with 0.5 percent of the 14,256 wisdom tooth patients who didn’t fill a prescription.” 

Set aside the fact this study shows prolonged use is very low. Is there something inherently bad about refilling opioid prescriptions and staying on opioids longer than the average person if one is not addicted? Since we know that opioids have very few harmful effects on organs compared to alcohol, acetaminophen, or NSAIDs (with prolonged use), and since the addiction and misuse rate is somewhere around 1 percent, why are the authors so upset if some people stay on the drug longer than others. The lead author calls this a “long term ill effect.” Really?

Meanwhile, on the same day, another research letter was also published in JAMA by researchers at Brigham and Women’s Hospital in Boston that looked at 1.3 million patients who received 22 types of surgical procedures between the years 2004 and 2015. The study found a 30-day post-discharge overdose rate of 10.3 per 100,000 patients (0.01 percent), dropping to 3.2 overdoses per 100,000 patients (0.0032 percent) for those 61 to 90 days post-discharge. The authors found overdoses within 30 days post-discharge were very low in patients who were “opioid naïve”—2.8 per 100,000 patients (0.0028 percent)—as opposed to patients who were receiving opioids prior to surgery. In patients who were chronically receiving high-dose opioids prior to the operation (defined by the authors as greater than the equivalent of 100mg of morphine per day) that rate jumped to 142.5 per 100,000 patients (0.14 percent).

The authors stated in their concluding discussion:

This study demonstrated that opioid overdose after surgical discharge was rare. Patients were at risk of experiencing an overdose after leaving the hospital, especially in the first month. Furthermore, patients using high quantities of opioids preoperatively were at a heightened risk compared with those not receiving high-dose opioid therapy prior to the operation.”

The big takeaway from this study is that overdose rates in patients discharged on opioids postoperatively are extremely low—even in those who had been chronically receiving high-dose opioids preoperatively. But the authors of the study spent most of the time discussing the fact that overdoses can and do occur in patients discharged from surgery on opioids and occur more frequently in patients who had been on opioids preoperatively.

Give credit to the medical news service MedPage Today for providing dispassionate, no-spin coverage to both studies by covering them together in a story on August 7 entitled: “Post-Surgery Overdoses Are Rare—but higher odds of persistent use seen following some procedures.”

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Politics, Confirmation Bias, and Opioids

This post co-authored with Rafael Fonseca, MD, Chairman of the Department of Medicine, Mayo Clinic, Phoenix, AZ

Much has been written about how politics and ideology influence research funding, suppress research in certain areas, and lead to the cherry-picking and misrepresentation of evidence in support of a narrative or agenda. Science journalist John Tierney explored “The Real War on Science” in an excellent essay in City Journal in 2016. Reflecting on this phenomenon in 2011, Patrick J. Michaels stated:

The process is synergistic and self-fulfilling. Periodicals like Science are what academia uses to define the current truth. But the monolithic leftward inclination of the reviewing   community clearly permits one interpretation (even if not supported by the results) and not another. This type of blatant politicized science is becoming the norm in the environmental arena, and probably has infiltrated most every other discipline, too.

It certainly has infiltrated research into the emotionally charged opioid overdose problem afflicting the US and many other western nations. Policy decisions have been rooted in a narrative seemingly immune to the facts: that the problem is largely the result of greedy pharmaceutical companies manipulating careless and poorly-trained doctors into “hooking” patients on highly addictive opioids and condemning them to a nightmarish life of drug addiction.

Tierney writes of confirmation bias—the tendency of people to seek out and accept information that confirms their beliefs and prejudices. He bemoans the “groupthink” that allows confirmation bias to infiltrate the peer review process. He cites a well-known study that demonstrated reviewers were more likely to find problems with a study’s methodology if the findings were contrary to their prejudices yet overlook methodological shortcomings if the findings were confirmatory.

Sometimes investigators try to “spin” their findings to make them comport to the narrative and appear confirmatory, increasing the likelihood that their research gets published. 

Both of us are practicing physicians, and each of us recently experienced reminders that research into the opioid overdose issue is not exempt from politicization and confirmation bias. We would like to present two recent examples where this confirmation bias became self-evident. 

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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.

 

Methadone and Mixed Messages

As a physician licensed to prescribe narcotics, I am legally  permitted to prescribe the powerful opioid methadone (also known by the brand name Dolophine ) to my patients suffering from severe, intractable pain that hasn’t been adequately controlled by other, less powerful pain killers. Most patients I encounter who might fall into that category are likely to be terminal cancer patients. I’ve often wondered why I am approved to prescribe methadone to my patients as a treatment for pain, but I am not allowed to prescribe methadone to taper my patients off of a physical dependence they may have developed from long-term opioid use, so as to help them avoid the horrible acute withdrawal syndrome. I am also not permitted to prescribe methadone as a medication-assisted treatment for addiction. These last two uses of the drug require special licensing and permits and must comply with strict federal guidelines. 

The synthetic opioid methadone was invented in Germany in 1937. By the 1960s, methadone was found to be effective as medication-assisted treatment for heroin addiction, and by the 1970s methadone treatment centers were established throughout the US, providing specialized and highly structured care for patients suffering from Substance Abuse Disorder. The Narcotic Addict Treatment Act of 1974 codified the methadone clinic structure. Today, methadone clinics are strictly regulated by the Drug Enforcement Administration, the National Institute on Drug Abuse, the Substance and Mental Health Services Administration, and the Food and Drug Administration. These regulations establish guidelines for the establishment, structure, and operation of methadone clinics, in most cases requiring patients to obtain their methadone in person at one fixed site. After a period of time, some of these patients are allowed to take methadone home from the facility to self-administer while they remain closely monitored. This onerous regulatory system has led to an undersupply in methadone treatment facilities for patients in need. Furthermore, the need for patients to travel, often long distances, each day to the clinic to receive their daily dose has been an obstacle to their obtaining and complying with the treatment program.

Earlier this month addiction specialists from the Boston University School of Medicine and Public Health and the Massachusetts Department of Public Health argued in the New England Journal of Medicine that community physicians interested in the treatment of Substance Abuse Disorder should be allowed to prescribe methadone to their patients seeing them in their offices and clinics. Doctors have been allowed to prescribe the opioid buprenorphine for medication-assisted treatment of addiction for years, and in recent years nurse practitioners and physicians’ assistants have been able to obtain waivers that allow them to engage in medication-assisted treatment as well.

The authors noted that methadone has been legally prescribed by primary care providers to treat opioid addiction in other countries for many years— in Canada since 1963, in the UK since 1968, and in Australia since 1970, for example. They state, 

Methadone prescribing in primary care is standard practice and not controversial in these places because it benefits the patient, the care team, and the community and is viewed as a way of expanding the delivery of an effective medication to an at-risk population.

Policymakers serious about addressing the ever-increasing overdose rate from (mostly) heroin and fentanyl afflicting our population should take a serious look at reforming the antiquated regulations that hamstring the use of methadone to treat addiction.

 

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