Tag: addiction

Today’s Drug Abusers Did Not Derive From Yesterday’s Patients

We learned last week that the 2017 drug overdose numbers reported by the US Centers for Disease Control and Prevention clearly show most opioid-related deaths are due to illicit fentanyl and heroin, while deaths due to prescription opioids have stabilized, continuing a steady trend for the past several years. I’ve encouraged using the term “Fentanyl Crisis” rather than “Opioid Crisis” to describe the situation, because it more accurately points to its cause—nonmedical users accessing drugs in the dangerous black market fueled by drug prohibition—hoping this will redirect attention and lead to reforms that are more likely to succeed. But the media and policymakers remain unshakably committed to the idea that the overdose crisis is the product of greedy pharmaceutical companies manipulating gullible and poorly-trained doctors into over-prescribing opioids for patients in pain and ensnaring them in the nightmare of addiction.

As a result, most of the focus has been on pressing health care practitioners to decrease their prescribing, imposing guidelines and ceilings on daily dosages that may be prescribed, and creating surveillance boards to enforce these parameters. These guidelines are not evidence-based, as Food and Drug Administration Commissioner Scott Gottlieb seems to realize, and have led to the abrupt tapering of chronic pain patients off of their medication, making many suffer desperately. An open letter by distinguished pain management experts appeared last week in the journal Pain Medicine criticizing current policies for lacking a basis in scientific evidence and generating a “large-scale humanitarian issue.” 

Current policy has brought high-dose prescriptions down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year. Yet overdose deaths continue to mount year after year, up another 9.6 percent in 2017.

One might expect the obvious prevalence of heroin and illicit fentanyl among overdose deaths would make policymakers reconsider the relationship between opioid prescribing, nonmedical use, and overdose deaths. The data certainly support viewing the overdose crisis as an unintended consequence of drug prohibition: nonmedical users preferred to use diverted prescription opioids and, as supplies became tougher to come by in recent years, the efficient black market responded by filling the void with cheaper and more dangerous heroin and fentanyl.

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.

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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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.

 

No, Babies Are NOT Born Addicted to Opioids

“A crisis is a terrible thing to waste,” is a phrase coined by Stanford economist Paul Romer. Politicians are always in search of new crises to address—new fires to put out—with rapid and decisive action. In their passion to appear heroic to their constituents they often act in haste, not taking the time to develop a deep and nuanced understanding of the issue at hand, insensitive to the notion that their actions might actually exacerbate the crisis.

An example of that lack of understanding was made apparent in a press release by the office of House Majority Whip Steve Scalise (R-LA) on June 22 supporting legislation that packages together over 70 bills (H.R.6) aimed at addressing the opioid (now mostly heroin and fentanyl) overdose crisis. The bills mostly double down on the same feckless—often deleterious—policies that government is already using to address the crisis. The release stated, “Whip Scalise highlighted a Slidell, Louisiana family whose son was born addicted to opioids, a syndrome called NAS, as a result of his mother’s battle with addiction.” 

The press release quoted Representative Scalise:

I highlight Kemper, a young boy from my district in Slidell, Louisiana. He was born addicted to opioids because his mother, while she was pregnant, was addicted to opioids herself…this example highlights something the Centers for Disease Control has noted. That is once every 25 minutes in America a baby is born addicted to opioids. Once every 25 minutes. That’s how widespread it is, just for babies that are born.

Before crowing that the “House Takes Action to Combat the Opioid Crisis,” as the press release was titled, Representative Scalise should get his science right. No baby is ever born addicted to opioids. As medical science has known for years, there is a difference between addiction and physical dependence—on a molecular level. Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse pointed out in a 2016 article in the New England Journal of Medicine that addiction is a disease, and “genetic vulnerability accounts for at least 35 to 40% of the risk associated with addiction.” Addiction features compulsive drug use in spite of harmful, self-destructive consequences.

Physical dependence, on the other hand, is very different. As with many other classes of drugs, including antidepressants like Prozac or Lexapro, long-term use of opioids is associated with the development of a physical dependence on the drug. Abruptly stopping the drug can lead to severe withdrawal symptoms. A physically dependent patient needs the drug in order to function while avoiding withdrawal. Dependence is addressed by gradually reducing the dosage of the drug over a safe time frame. Once the dependence is overcome, such a patient will not have a compulsion to resume the drug.

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.

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.