How FDA Failures Contributed to the Opioid Crisis

Andrew Kolodny, MD

AMA J Ethics. 2020;22(8):E743-750. 

doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Introduction

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

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Oversight Recommendations

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage initiation of long-term opioids.

To finally end the opioid crisis, the FDA must enforce the Food, Drug, and Cosmetic Act, and it must act on recommendations from the NAS for an overhaul of its opioid approval and removal policies. The broad indication on opioid labels must be narrowed, and an explicit warning against long-term use and high-dose prescribing should be added. The label should reinforce, rather than contradict, guidance from the CDC, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and other public health agencies that are calling for more cautious prescribing.

The information is here.

What We’re Not Talking about When We Talk about Addiction

Hanna Pickard

The Hastings Center

Originally posted 28 Aug 20

Abstract

The landscape of addiction is dominated by two rival models: a moral model and a model that characterizes addiction as a neurobiological disease of compulsion. Against both, I offer a scientifically and clinically informed alternative. Addiction is a highly heterogeneous condition that is ill-characterized as involving compulsive use. On the whole, drug consumption in addiction remains goal directed: people take drugs because drugs have tremendous value. This view has potential implications for the claim that addiction is, in all cases, a brain disease. But more importantly, it has implications for clinical and policy interventions. To help someone overcome addiction, you need to understand and address why they persist in using drugs despite negative consequences. If they are not compelled, then the explanation must advert to the value of drugs for them as an individual. What blocks us from acknowledging this reality is not science but fear: that it will ignite moralism about drugs and condemnation of drug users. The solution is not to cleave to the concept of compulsion but to fight moralism directly.

The article is here.

Addiction, Identity, Morality

Earp, B.D., Skorburg, J.A. Everett, J. & Savulescu, J.
(2019) AJOB Empirical Bioethics, 10:2, 136-153.
DOI: 10.1080/23294515.2019.1590480

Background: Recent literature on addiction and judgments about the characteristics of agents has focused on the implications of adopting a “brain disease” versus “moral weakness” model of addiction. Typically, such judgments have to do with what capacities an agent has (e.g., the ability to abstain from substance use). Much less work, however, has been conducted on the relationship between addiction and judgments about an agent’s identity, including whether or to what extent an individual is seen as the same person after becoming addicted.

Methods: We conducted a series of vignette-based experiments (total N = 3,620) to assess lay attitudes concerning addiction and identity persistence, systematically manipulating key characteristics of agents and their drug of addiction.

Conclusions: In Study 1, we found that U.S. participants judged an agent who became addicted to drugs as being closer to “a completely different person” than “completely the same person” as the agent who existed prior to the addiction. In Studies 2–6, we investigated the intuitive basis for this result, finding that lay judgments of altered identity as a consequence of drug use and addiction are driven primarily by perceived negative changes in the moral character of drug users, who are seen as having deviated from their good true selves.

The research is here.

The Sacklers were drug dealers who put money over morality.

Chris McGreal
The Guardian
Originally published September 17, 2019

If only we could feel Purdue Pharma’s pain.

The directors and owners of the company that did so much to create America’s opioid epidemic are professing distress and bewilderment at the rejection of what they claim are its good faith efforts to help the victims.

Even as Purdue announced plans late Sunday night to file for bankruptcy, its top officials were making unctuous claims that their concern was to combat an epidemic that has claimed more than 400,000 lives. Anyone who stood in the way was depriving suffering Americans of the help they need, they claimed.

Members of the Sackler family who own Purdue have offered to turn over the company to a trust which would funnel future earnings to treatment and other measures to deal with the tragedy. They would also sell Mundipharma, a British-based sister company, and hand over the payment. The Sacklers even said they would give up a part of the huge profits of OxyContin, which made the family multibillionaires.

Some of the state attorneys general and cities suing Purdue have accepted the deal as the best prospect for getting anything out of the company and said the bankruptcy filing was part of the arrangement.

Other attorneys general rejected the move, claiming it was an attempt by Purdue’s owners and executives to hang on to the bulk of the profits of drug dealing and buy their way out of individual accountability. Some of those states are also suing the Sacklers directly.

The info is here.

Ordinary people associate addiction with loss of free will

A. J. Vonasch, C. J. Clark, S. Laub, K. D. Vohs, & R. F. Baumeister
Addictive Behaviors Reports
Volume 5, June 2017, Pages 56-66

Introduction
It is widely believed that addiction entails a loss of free will, even though this point is controversial among scholars. There is arguably a downside to this belief, in that addicts who believe they lack the free will to quit an addiction might therefore fail to quit an addiction.

Methods
A correlational study tested the relationship between belief in free will and addiction. Follow-up studies tested steps of a potential mechanism: 1) people think drugs undermine free will 2) people believe addiction undermines free will more when doing so serves the self 3) disbelief in free will leads people to perceive various temptations as more addictive.

Results
People with lower belief in free will were more likely to have a history of addiction to alcohol and other drugs, and also less likely to have successfully quit alcohol. People believe that drugs undermine free will, and they use this belief to self-servingly attribute less free will to their bad actions than to good ones. Low belief in free will also increases perceptions that things are addictive.

Conclusions
Addiction is widely seen as loss of free will. The belief can be used in self-serving ways that may undermine people's efforts to quit.

The research is here.

Do psychotropic drugs enhance, or diminish, human agency?

Rami Gabriel
aeon.co
Originally posted September 3, 2018

Here is an excerpt:

Psychological medications such as Xanax, Ritalin and aspirin help to modify undesirable behaviours, thought patterns and the perception of pain. They purport to treat the underlying chemical cause rather than the social, interpersonal or psychodynamic causes of pathology. Self-knowledge gained by introspection and dialogue are no longer our primary means for modifying psychological states. By prescribing such medication, physicians are implicitly admitting that cognitive and behavioural training is insufficient and impractical, and that ‘the brain’, of which nonspecialists have little explicit understanding, is in fact the level where errors occur. Indeed, drugs are reliable and effective because they implement the findings of neuroscience and supplement (or in many cases substitute for) our humanist discourse about self-development and agency. In using such drugs, we become transhuman hybrid beings who build tools into the regulatory plant of the body.

Recreational drugs, on the other hand, are essentially hedonic tools that allow for stress-release and the diminishment of inhibition and sense of responsibility. Avenues of escape are reached through derangement of thought and perception; many find pleasure in this transcendence of quotidian experience and transgression of social norms. There is also a Dionysian, or spiritual, purpose to recreational inebriation, which can enable revelations that enhance intimacy and the emotional need for existential reflection. Here drugs act as portals into spiritual rituals and otherwise restricted metaphysical spaces. The practice of imbibing a sacred substance is as old as ascetic and mindfulness practices but, in our times, drugs are overwhelmingly the most commonly used tool for tending to this element of the human condition.

The info is here.

Don't Blame PPC, Blame Poor Ethics

Kyle Infante
Forbes.com
Originally posted on February 2, 2018

Here is an excerpt:

To sum up the entire debacle in a nutshell: Marketing entities would create referral ads and websites to bid on highly sought after addiction keywords, drive traffic to their call centers and send people to facilities-based purely on profit. There was no clinical or medical prescreening being conducted, no thought put into placing that individual with the appropriate level of care. Suffering addicts and alcoholics were being misled by strategic digital marketing tactics and pushed to the highest bidder. Often, these high bidders had a slew of ethical issues. This drove the cost per click for each ad through the roof, and soon enough only the Goliaths could compete on PPC (pay per click). Unless you had the money to hire an advertising agency or had an in-house marketer with extensive digital experience, there was no way to survive.

Recently, Google stepped in and placed restrictions on these ads to curb the gross abuse of the market. In September 2017, Google began to limit the kinds of ads facilities could create and just this year placed a temporary ban on all recovery ads to audit the entire industry.

The article is here.

Drug Companies’ Liability for the Opioid Epidemic

Rebecca L. Haffajee and Michelle M. Mello
N Engl J Med 2017; 377:2301-2305
December 14, 2017
DOI: 10.1056/NEJMp1710756

Here is an excerpt:

Opioid products, they alleged, were defectively designed because companies failed to include safety mechanisms, such as an antagonist agent or tamper-resistant formulation. Manufacturers also purportedly failed to adequately warn about addiction risks on drug packaging and in promotional activities. Some claims alleged that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives.

These suits faced formidable barriers that persist today. As with other prescription drugs, persuading a jury that an opioid is defectively designed if the Food and Drug Administration approved it is challenging. Furthermore, in most states, a drug manufacturer’s duty to warn about risks is limited to issuing an adequate warning to prescribers, who are responsible for communicating with patients. Finally, juries may resist laying legal responsibility at the manufacturer’s feet when the prescriber’s decisions and the patient’s behavior contributed to the harm. Some individuals do not take opioids as prescribed or purchase them illegally. Companies may argue that such conduct precludes holding manufacturers liable, or at least should reduce damages awards.

One procedural strategy adopted in opioid litigation that can help overcome defenses based on users’ conduct is the class action suit, brought by a large group of similarly situated individuals. In such suits, the causal relationship between the companies’ business practices and the harm is assessed at the group level, with the focus on statistical associations between product use and injury. The use of class actions was instrumental in overcoming tobacco companies’ defenses based on smokers’ conduct. But early attempts to bring class actions against opioid manufacturers encountered procedural barriers. Because of different factual circumstances surrounding individuals’ opioid use and clinical conditions, judges often deemed proposed class members to lack sufficiently common claims.

The article is here.

Did I just feed an addiction? Or ease a man’s pain? Welcome to modern medicine’s moral cage fight

Jay Baruch
STAT News
Originally published October 23, 2017

Here are two excerpts:

Will the opioid pills Sonny is asking for treat his pain, feed an addiction, or both? Will prescribing it fulfill my moral responsibility to alleviate his distress, contribute to the supply chain in the illicit pill economy, or both? Prescribing guidelines from the Centers for Disease Control and Prevention and recommendations from medical specialties and local hospitals are well-intentioned and necessary. But they do little to address the central anxiety that makes this decision a source of distress for physicians like me. It’s hard to evaluate pain without making some judgment about the patient and the patient’s story.

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A good story shortcuts analytical thinking. It can work its charms without our knowledge and sometimes against our better judgment. Once an emotional connection is made and the listener becomes invested in the story, the believability of the story matters less. In fact, the more extreme the story, the greater its capacity to enthrall the listener or reader.

Stories can elicit empathy and influence behavior in part by stimulating the release of the neurotransmitter oxytocin, which has ties to generosity, trustworthiness, and mother-infant bonding. I’m intrigued by the possibility that clinicians’ vulnerability to deceit is often grounded in the empathy they are reported to be lacking.

The article is here.

Would We Even Know Moral Bioenhancement If We Saw It?

Wiseman H.
Camb Q Healthc Ethics. 2017;26(3):398-410.

Abstract

The term "moral bioenhancement" conceals a diverse plurality encompassing much potential, some elements of which are desirable, some of which are disturbing, and some of which are simply bland. This article invites readers to take a better differentiated approach to discriminating between elements of the debate rather than talking of moral bioenhancement "per se," or coming to any global value judgments about the idea as an abstract whole (no such whole exists). Readers are then invited to consider the benefits and distortions that come from the usual dichotomies framing the various debates, concluding with an additional distinction for further clarifying this discourse qua explicit/implicit moral bioenhancement.

The article is here, behind a paywall.

Email the author directly for a personal copy.

Google Sets Limits on Addiction Treatment Ads, Citing Safety

Michael Corkery
The New York Times
Originally published September 14, 2017

As drug addiction soars in the United States, a booming business of rehab centers has sprung up to treat the problem. And when drug addicts and their families search for help, they often turn to Google.

But prosecutors and health advocates have warned that many online searches are leading addicts to click on ads for rehab centers that are unfit to help them or, in some cases, endangering their lives.

This week, Google acknowledged the problem — and started restricting ads that come up when someone searches for addiction treatment on its site. “We found a number of misleading experiences among rehabilitation treatment centers that led to our decision,” Google spokeswoman Elisa Greene said in a statement on Thursday.

Google has taken similar steps to restrict advertisements only a few times before. Last year it limited ads for payday lenders, and in the past it created a verification system for locksmiths to prevent fraud.

In this case, the restrictions will limit a popular marketing tool in the $35 billion addiction treatment business, affecting thousands of small-time operators.

The article is here.

Is Addiction a Brain Disease?

Kent C. Berridge
Neuroethics (2016). pp 1-5.
doi:10.1007/s12152-016-9286-3

Abstract

Where does normal brain or psychological function end, and pathology begin? The line can be hard to discern, making disease sometimes a tricky word. In addiction, normal ‘wanting’ processes become distorted and excessive, according to the incentive-sensitization theory. Excessive ‘wanting’ results from drug-induced neural sensitization changes in underlying brain mesolimbic systems of incentive. ‘Brain disease’ was never used by the theory, but neural sensitization changes are arguably extreme enough and problematic enough to be called pathological. This implies that ‘brain disease’ can be a legitimate description of addiction, though caveats are needed to acknowledge roles for choice and active agency by the addict. Finally, arguments over ‘brain disease’ should be put behind us. Our real challenge is to understand addiction and devise better ways to help. Arguments over descriptive words only distract from that challenge.

The article is here.

When regulators close a 'pill mill,' patients sometimes turn to heroin

By Rich Lord
Pittsburgh Post-Gazette
Originally published May 25, 2016

Here is an excerpt:

In late 2013, Maryland launched its prescription drug monitoring program, allowing — but not requiring — doctors to access a database to see the drug histories of their patients. Nearly every state has such a system, designed to thwart people who seek drugs from multiple doctors. Some state medical boards use the data to flag physicians whose prescribing goes out of bounds.

Maryland’s board, though, can’t tap into the data “without going through major legal hoops,” Dr. Singh said. Physician groups, he said, have opposed efforts to ease access, because they fear “over-policing.”

Maryland has not adopted official opioid prescribing guidelines, as some states have.

The article is here.

FDA Reconsiders Training Requirement for Painkillers

BY Matthew Perrone
AP HEALTH WRITER
Originally published April 29, 2016

The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents.

The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency.

A panel of FDA advisers meets next week to review risk-management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death.

The article is here.

If obesity is a moral failing, then our morals have failed.

By Anke Snoek
Aeon Magazine - Ideas
Originally published July 6, 2015

Here is an excerpt:

But there’s another reason to be cautious about calling obesity a moral failing. The lay vision is that obese people act on their desires rather than on their better judgment, but recent research of Nora Volkow shows some striking parallels between addiction and obesity. Evolutionarily, we are wired to find certain foods and activities – the ones that contribute more to our survival – more attractive than others. That’s why when we engage in positive social relationships, sex, or eat food with high fat, sugar or salt content, dopamine is released in the brain. Dopamine is often associated with pleasure. We get a pleasurable feeling when we eat good food, but dopamine also contributes to conditioned learning and so-called incentive sensitization. That is, we become sensitive to cues linked to rewarding behaviour or food which was important but scarce in the distant past.  In prehistoric times we learned which cues predict, for instance, where the best fruit trees grow.

The entire article is here.

Drug Addiction Seen as 'Moral Failing,' Survey Finds

By Robert Preidt
HealthDay Reporter
Originally posted on October 3, 2014

People with drug addiction are much more likely to face stigma than those with mental illness because they're seen as having a "moral failing," according to a new survey.

The poll of more than 700 people across the United States also found that the public is less likely to approve of insurance, housing and employment policies meant to help people with drug addiction.

The study results suggest that many people consider drug addiction a personal vice rather than a treatable medical condition, according to the Johns Hopkins Bloomberg School of Public Health researchers.

The entire article is here.

Is Neurolaw Conceptually Confused?

By Neil Levy
J Ethics. 2014 Jun 1;18(2):171-185.

Abstract

In Minds, Brains, and Law, Michael Pardo and Dennis Patterson argue that current attempts to use neuroscience to inform the theory and practice of law founder because they are built on confused conceptual foundations. Proponents of neurolaw attribute to the brain or to its parts psychological properties that belong only to people; this mistake vitiates many of the claims they make. Once neurolaw is placed on a sounder conceptual footing, Pardo and Patterson claim, we will see that its more dramatic claims are false or meaningless, though it might be able to provide inductive evidence for particular less dramatic claims (that a defendant may be lying, or lacks control over their behavior, for instance). In response, I argue that the central conceptual confusions identified by Pardo and Patterson are not confusions at all. Though some of the claims made by its proponents are hasty and sometimes they are confused, there are no conceptual barriers to attributing psychological properties to brain states. Neuroscience can play a role in producing evidence that is more reliable than subjective report or behavior; it therefore holds out the possibility of dramatically altering our self-conception as agents and thereby the law.

The entire article is here.

How A Big Drug Company Inadvertently Got Americans Hooked On Heroin

By Jillian Berman
The Huffington Post
Originally posted February 24, 2014

Here is an excerpt:

In recent years, more prescription drug abusers have started turning to heroin for a cheaper high as the price of pills skyrockets on the black market, Bunt said. Two factors have contributed to the cost increase: opioid addiction boosting demand and doctors becoming more cautious about prescribing opioids, decreasing supply, Bunt said.

Another reason for the price increase: The Drug War, according to a January 2012 report from Radley Balko. Government crackdowns have made it difficult for even reputable doctors to prescribe pain pills. To fill the void, doctors and others looking to make a buck off the prescription pills created so-called "pill mills" -- offices that prescribe pain medication in high volume and often serve people addicted to the drugs.

The entire article is here.

Perception of Addiction and Its Effects on One's Moral Responsibility

By Justin Caouette
AJOB Neuroscience
Volume 4, Issue 3, 2013

Addressing concerns about framing addiction as disease, authors (Hammer et. al 2013) argue that we should refrain from doing so as such a categorization may unfairly stigmatize the addict.  They suggest that an analysis of disease metaphors bolsters their view, and the utility that could be had by labeling addiction as disease is outweighed by the potential disutility in doing so. Tolend support to their view they appeal to intuitions about the common folk‟s analysis of diseased individuals. Their claim is that a common understanding of disease unfairly depicts addicts as “wretches” or “sinners”.   They use this as evidence in favor of rejecting the addiction -as-disease model. We argue that the author‟s metaphoric framing of how common folks often view diseased individuals is misguided for a number of reasons. We focus on three points of contention.

The entire piece is here.

Viewpoint: We Need to Rethink Rehab

By David Sheff
Time
Originally published April 3, 2013

Here are some excerpts:

I’ve already written about my experience with Nic, but for my new book, Clean, I wanted to understand why so many suffer and die. So I undertook an investigation of the treatment system that so often fails. I learned that no one actually knows how often treatment works, but an oft-quoted number of those who abstain from using for a year after rehab is 30%. Even that figure is probably high. “The therapeutic community claims a 30% success rate, but they only count people who complete the program,” according to Joseph A. Califano Jr., the founder of the National Center on Addiction and Substance Abuse and former U.S. Secretary of Health, Education, and Welfare. “Seventy to eighty percent drop out in three to six months.” Over the course of my research, I did hear one statistic that I trusted. Father John Hardin, chair of board of trustees at St Anthony’s, a social services foundation with an addiction recovery program in San Francisco, told me, “Success for us is that a person hasn’t died.”

The treatment system fails because it’s rooted in an entrenched but inaccurate view that addicts are morally bereft and weak. If they weren’t, the belief goes, they’d stop using when drugs begin to negatively impact their lives. Most treatment centers in America are based on an archaic philosophy that’s rooted in the Twelve-Step model of recovery. Twelve-Step programs have saved countless lives, but they don’t work for a majority of people who try them. It’s not a fault in the program itself. Its founder, Bill Wilson, wrote, “These are but suggestions.” But many rehabs require them. This is particularly problematic for teenagers and young adults, the very people most susceptible to addiction. Twelve-Step programs require people to accept their powerlessness and turn their lives over to God or another higher power. Many adolescents question religion and in general teenagers aren’t going to turn their lives over to anyone.

In many of these Twelve-Step-based programs, patients are berated and yelled at if they don’t “surrender” and practice the steps. They’re warned — in some cases, threatened — that if they don’t they’ll relapse and die. It can become a self-fulfilling prophecy.

The entire story is here.