We meet every client right where they are at on their spiritual journey, even if they have no spiritual journey at all.
Whenever the topic of faith comes up, there are almost always variations of opinions and strong viewpoints.
Let’s look at dispelling five of the most common myths about faith-based addiction treatment programs.
Myth #1: Patients Are Not Interested in Faith Programming
Dr. David Rosmarin is a psychology professor at Harvard and the Director of Mental Health and Spirituality at McLean hospital, ranked number one in psychiatric hospitals for adults in the county by Healio Psychiatry. Dr. Rosmarin was a guest on my Faith in Recovery radio show in June 2018. What’s interesting is that of the top ten psychiatric hospitals throughout the country, McLean hospital is the only one that has a spirituality program. McLean conducted a study on the significance of spirituality as it relates to mental illness.
In a study on the significance of spirituality as it relates to mental illness, 58.2% of patients coming into McLean’s psychiatric unit requested to have spirituality/faith programming as part of their treatment. According to an article McLean published on April 25, 2013, “Our work suggests that people with a moderate to high level of belief in a higher power do significantly better in short-term psychiatric treatment. The study concludes belief in God is associated with improved outcomes in psychiatric treatment.”
This brings us to the obvious question! Why is McLean hospital the only one of the major psychiatric hospitals who offers faith programming? I believe it has much to do with the increased politically correct environment. People are afraid to offend anyone, in particular regarding the topics of religion and mental illness. People may feel as if they are walking around on egg shells, which results in overlooking programs that are proven to be effective. Let’s not put political correctness over the many people afflicted with mental illness or substance use dependency who are in desperate need of help.
Myth #2: Faith Programs Are Judgmental and Condemning
As a Chaplain in our Faith in Recovery program, the three things I hear the most are: “Why does God allow suffering?” “How do I know what God’s will is for my life?” And the last one is a statement: “I stopped going to church because I was forced to go when I was young and all I felt when going was guilt, shame and judgement, so I stopped going.”
According to the 2017 Lifeway research survey, “66% of Americans between 23 to 30 years old stopped attending church on a regular basis after turning 18.” It’s a sad commentary on the Church, especially since it’s supposed to be a place of healing and acceptance. I experienced the same thing growing up and as soon as I was old enough to stop going, I did just that.
Not all churches have a judgmental environment. There are some incredible churches out there, but the damage has been done and it’s difficult to turn the perception around. What is disturbing is the fact that the teachings of Christ and all that He did were the exact opposite of guilt, shame and judgement. Apparently somewhere during the past two thousand years some churches didn’t get the memo.
A faith-based program in a treatment setting at its core must be non-judgmental. The majority of our patients are coming in with tremendous guilt and shame. The last thing they need is to have more of that directed their way. In fact, one of our groups is called “Overcoming Guilt & Shame.” When coming into treatment for substance use dependency or mental health disorders, patients need to be treated with respect, and they need to know that God loves them. He wants to forgive them and has a plan for their lives. It must be emphasized that they have value and a purpose and most importantly God values them. When people truly begin to realize these things, the light begins to open their eyes and the seeds of hope emerge. It’s an incredible sight to witness and I am blessed to have a front row seat on a daily basis.
Myth #3: I Won’t Fit In, I’m Not Very Religious
I think this is similar to any topic that we do not feel we are well-versed in or do not know much about. In general, we tend to shy away from the things we are unfamiliar with or which we associate with a bad experience. Not fitting in is simply not the case. We meet every client right where they are at on their spiritual journey, even if they have no spiritual journey at all. We have patients who grew up in the Church and fell away, those who never stepped foot in a church, devout atheists, agnostics, Jewish, Muslim, Buddhist, and those coming out of the occult. All are welcome and treated the same.
Often times in 12-step treatment, the default setting is “I already heard this.” This contrasts with the faith programming most patients have never heard. This is all new information to them, which gives us a fighting chance to keep their attention. More importantly, our patients begin to face their fears. They realize they are much stronger than they think they are.
Myth #4: They Will Force Me to Convert
One of the things we hear in our faith program is: “I liked it because beliefs were not forced on me.” As one of our former patients, Richard, said in his testimonial video, “One of my biggest things is there’s a connection with God, but I don’t want Him shoved down my throat all day long… it’s so far from that, but it’s so connected it’s amazing.” I believe the reason so many feel this way relates back to what we discussed earlier: They were forced into attending church. We all know when forced into something–especially in our adolescence–we tend to rebel against it.
The reality is God gave us the gift of free will. He never forces us to do anything, so why should we force Faith on someone? All we can do is plant the seeds and water them. God is the one who transforms people’s hearts. We do not have the capacity to change someone’s heart.
Myth #5: We Will Not Be Allowed to Share Our Views
This point actually came from a group in our Faith in Recovery program after I asked for their feedback on myths about faith programming. A few patients stated that one of the concerns they had prior to coming into the program was that they would be talked down to and their opinions would not be heard. After experiencing the group, the consensus was that it was the opposite of this concern; that they were actually encouraged to share their thoughts and perspectives on their faith and to always ask questions.
When patients feel that they are not being heard, they tend to shut down completely. This is the exact opposite of what we are trying to have them accomplish in treatment. Transparency and being completely open is an essential part of getting better. Most patients have been suppressing things for far too long so the last thing we want them to do is shut down.
It’s not surprising that people have this preconceived notion of faith programming as they may be associating it with the years of sitting in the pews being preached to with little opportunity to ask questions. We focus on who our patients are becoming, not on who they were in active addiction. What I witness on a daily basis is patients encouraging one another, praying for each other and providing a listening ear to someone who is struggling.
If those who are in treatment are given the opportunity to speak, you will be surprised at the profound and insightful things they have to say.
War, disasters, trafficking and immigration are tearing millions of children from their parents all around the world. A psychologist explores how to help them recover.
Q&A with Developmental Psychologist Hirokazu Yoshikawa
The US immigration policy that has separated more than 5,400 children from their parents had spurred psychologists and pediatricians to warn that the young people face risks ranging from psychological distress and academic problems to long-lasting emotional damage. But this represents just a tiny part of a growing global crisis of parent-child separation.
Throughout the world, wars, natural disasters, institutionalization, child-trafficking, and historic rates of domestic and international migration are splitting up millions of families. For the children involved, the harm of separation is well-documented.
Hirokazu Yoshikawa, a developmental psychologist at New York University who codirects NYU’s Global TIES for Children, recently looked into research on the impacts of parent-child separation and the efficacy of programs meant to help heal the damage. Writing in the debut issue of the Annual Review of Developmental Psychology, he and colleagues Anne Bentley Waddoups and Kendra Strouf call for an increase in mental health training for teachers, medical doctors or other frontline service providers who can help fill the gap left by the lack of mental health providers available to cope with the many millions of children affected.
Knowable Magazine recently spoke with Yoshikawa about the crisis and what can be done about it. This conversation has been edited for length and clarity.
Are there any good estimates of the number of children throughout the world who’ve been separated from their parents?
Exact numbers are hard to pin down, especially because several of the categories involved — like child soldiers and child-trafficking — aren’t well reported. What we know for sure is that the number of people around the world being displaced from their homes is at a historically high level. In 2018, some 70.8 million individuals were forcibly displaced due to armed conflicts, wars and disasters. That’s a record, and given that these phenomena often result in family separations and that more than half of these individuals were children under the age of 18, it suggests that historic numbers of children have been separated from their parents.
Why have such family separations become more common?
Many factors are driving it, but climate change is playing an increasing role in displacement and armed conflict all over the world. Climate change reduces access to dwindling resources and contributes to natural disasters, like floods, droughts, crop failures and famine. All of this increases conflicts, drives migration and breaks up families. This is not a blip in history; it’s a trend we will have to live with for generations to come.
What’s most important to know about the damage that comes from children being separated from their parents?
There are thousands of studies on the power of disruptions of children’s early attachments to their parents to cause longstanding problems. We’re talking about cognitive, social-emotional and other mental health impacts.
The developmental study of the mechanisms that may explain why these separations are so harmful goes back to before World War II, with the work of psychoanalysts and scholars such as Anna Freud, John Bowlby and Mary Ainsworth. In 1943, Anna Freud and Dorothy Burlingame studied children who’d been evacuated from London and learned that in many cases being separated from their mothers was more traumatic for them than having been exposed to air raids. When families left London but stayed together, the children behaved more or less normally. But when children were separated from their mothers, they showed signs of severe trauma, such as wetting the bed and crying for long periods of time.
Later on, Bowlby and Ainsworth published their more well-known studies of how infants form attachments with their mothers, and how sensitive and responsive parenting is key to forming secure attachments both with parents and later on with others. Researchers have found that this process can be disrupted in prolonged separations — say of more than a week — before the age of 5.
More recently — for example, in the ongoing and high-profile studies of Romanian children who were raised in abysmally low-quality orphanages — researchers have shown how children in institutional care have suffered from poorer learning and social and emotional behavior due to the lack of intellectual and emotional stimulation and the opportunity to engage in relationships with caregivers.
How seriously children are affected can depend on factors such as whether the separation was voluntary or not, how long it lasts and what kind of care exists in its wake. Permanent loss of parents can create some of the most severe consequences, while long periods of parent-child separation, even if followed by reunification, can seriously disrupt a child’s emotional health. Children are generally more vulnerable to long-term harm to their social-emotional development in early childhood, up to five or six years, but no period of development is immune.
One major problem we see is that most children who are separated from their parents have already experienced some other trauma along the way, which then makes the separation even harder. When parents are present, they can often help buffer the impact of extreme adversity from bad experiences.
What did you learn that most surprised you as you reviewed the scientific literature?
The sheer range of outcomes was surprising to me — beyond learning and achievement and mental health outcomes, they include very basic human functions like impaired memory, auditory processing and planning. They also include a range of physiological outcomes related to stress that are themselves related to long-term disease and mortality. So parent-child separation as it is currently experienced can shorten lives and increase the chances of physical disease.
Meanwhile, something that didn’t surprise me because I’m immersed in this literature all the time, but will probably surprise your readers, is that there are now about 8 million children in the world living in institutional care. This is a problem that reflects the lack of robust foster care and capacity of governments to facilitate placement with relatives, who will generally give more stable care than strangers. As we state in our review, even in otherwise good-quality institutional care, children suffer due to the high turnover of caregivers.
What relevance does your work have for US policies that have led to many parents and children being separated at the border?
US officials should know that there’s a global consensus, expressed in the UN Convention on the Rights of Children, on how to respond to children’s needs in this context. Primarily that means avoiding separating children from parents whenever possible and, when it must happen, keeping it as short as possible. An overwhelming amount of research, going back to Bowlby, supports these guidelines.
Unfortunately, we don’t have a lot of research findings on children separated from their parents while awaiting detention. And it doesn’t make it any easier that the Department of Homeland Security has had so much trouble keeping track of the kids involved.
Yet there are hints of the kind of negative effects you might expect to see if you look at the research on children whose parents have been detained without warning, for example in large workplace raids to arrest undocumented workers. In these cases, researchers have found that children have missed school and suffered behavior problems and depressive symptoms.
This brings up the fact that, in the United States, we’re talking about many more than 5,000 children being separated from parents. While the separations at the Mexican border have gotten a lot of media attention, millions of other children across our country are affected by the relatively recent harsher, sweeping policies resulting in more detentions and deportations of immigrants already living in the US. This has created a climate in which the threat of family separation is omnipresent.
We’re particularly concerned that many children separated from their parents stop going to school, perhaps from lack of supervision or from the need to support themselves or family members. The humanitarian sector tends to focus on basic needs and that’s understandable — they want to save lives. But from a developmental perspective, we have to focus on whether children thrive, not just survive.
Unaccompanied children who are trying to migrate are an increasing part of this global problem. What kind of special risks do they face?
It’s true that there has been a significant increase in recent years in unaccompanied minors trying to migrate internationally. At the US border, this increase has been happening since the 1990s, due to both economic crises and increases in urban violence in Mexico and in Central American countries. But the trend is now accelerating. From 2015 to 2016, there were five times as many children estimated to be migrating alone than from 2010 to 2011. In 2017, more than 90 percent of undocumented children arriving in Italy were unaccompanied.
Compared with refugee children who flee with their families, unaccompanied children are at greater risk for trauma and mental illness. One study of refugee children attending a clinic in the Netherlands found that the unaccompanied children were significantly more likely than those traveling with their families to have been victim to four or more traumatic events in their lives, including during their travels. They also had a higher rate of depressive symptoms and even of psychosis than refugee children living with their families.
What are some of the best ways that governments and nonprofit organizations can help these children?
Whatever can be done to avoid the separation from parents in the first place and to avoid detention and institutionalization of children whenever possible is in the children’s best interests. (That’s the guidance from the Global Compact for Refugees, Article 9 of the Convention on the Rights of the Child, and other global rights documents.) After that, it’s a matter of limiting the time away from parents or other caring adults as much as possible. The earlier and younger that children leave institutional care for stable foster care or adoption, the better it is for them.
You can see this in some of the follow-ups of the study of children in Romanian orphanages. Children who left the orphanages for foster care by 15 months of age had trouble speaking and understanding in early childhood, but not later. Children placed before 30 months showed growth in learning and memory so as to be indistinguishable from other children by age 16. So recovery from early institutionalization is possible, but it may take longer if a child spent more time in the orphanage.
What kinds of programs for children, if any, can help lessen the impacts of being separated from their parents?
In general, programs that help equip children for their daily lives can be useful. That includes education in decision-making, problem-solving, communication and stress management.
Teachers and doctors can play a major role, at minimum by identifying children who need mental health services and directing them to programs. The fact is we’ll never have enough mental health providers, so it makes sense to train members of the education and basic health systems that are already in place.
In the review, we describe a few of these efforts. One that stood out for us took place in two schools in London where children on average aged 12 to 13 had been separated from one or both parents due to war or migration. They came from Kosovo, Sierra Leone, Turkey, Afghanistan and Somalia. Teachers identified children who needed services, and who then spent one hour a week for six weeks with a clinical psychology trainee doing cognitive behavioral therapy. The treatment helped reduce PTSD symptoms, and the children’s teachers later reported that the children were behaving better in the classroom.
Granted, this was a very small study with no longer-term follow-up, so you can’t draw very strong conclusions, but it hints that even such a short-term intervention can be helpful in addressing children’s traumas. Studies have shown that even as few as 12 sessions of counseling from people trained in cognitive behavioral principles can help many people.
Do we have any idea of how many kids are being helped by these sorts of interventions? Are we still mostly talking about small experiments?
We’re not anywhere close to meeting the need for services. Unfortunately, health systems worldwide continue to overlook all kinds of mental health needs, particularly in low-income countries, even as depression and other mental illnesses take an economic toll, leading to reduced lifespans and reduced economic activity. The economic costs of mental health problems are huge, yet this may be one of the most underinvested areas in terms of health care.
The largest program you describe is in China, which isn’t that surprising, given how many internal immigrants China has.
Yes, there are potentially tens of millions of Chinese children and youth whose parents travel to cities to work and leave them behind, in the care of grandparents or other relatives. Between one-third and 40 percent of children in rural areas of China are in this situation. And there’s a lot of research documenting that these children are doing less well than children who are being raised by parents.
We describe one community-based program involving 213 rural villages with nearly 1,200 left-behind children. For three years, each village designated a space for after-school activities for the youth and hired a full-time employee to provide welfare services. The findings suggest the approach helped reduce disparities between the left-behind and non-left-behind groups.
What if anything gives you hope that this situation may improve?
The outcry over the US policies has increased awareness about a very vulnerable population of children. That could be a silver lining of the crisis. These parent-child separations are going on not only at the border, but also all over the country. The hope is that the attention will increase support for organizations, such as the national Protecting Immigrant Families Coalition, that are working to make a difference.
When it comes to children throughout the world who’ve been separated from their parents, we need a lot more people to be aware and concerned so as to provide the attention, stimulation and care that can help them recover.
Editor’s note: This article was updated on January 24, 2020, to clarify that in addition to teachers and medical doctors, Dr. Yoshikawa and his colleagues also recommend mental health training for all frontline service providers.
Despite what we know about how overdoses can kill, there is scant literature regarding chronic health outcomes for people who have survived multiple overdoses.
Drug overdoses are a leading cause of preventable deaths in the United States. We know the dangers of overdoses; generally, they can kill. Opioids make up a large percentage of these deaths. In 2016, opioids made up 69 percent of drug overdose deaths. For people ages 25 to 64, drug overdoses cause more deaths than car accidents. Overdoses caused by opioids can be reversed if quickly countered with naloxone, an opioid antagonist.
In states like Massachusetts, opioid overdose deaths are on the decrease, but overdose emergency calls are on the rise. More people are surviving, but only 3 out of 10 people are receiving medical treatment for substance use disorder. What is happening to the other 70 percent of individuals?
Non-Opioid Overdoses
It is technically possible to overdose on nearly any recreational or medicinal drug available.
Cocaine overdose can involve seizures, heart attacks, strokes, and/or stop a person’s breathing. Amphetamine overdose can lead to seizures, cardiac arrest, and/or a huge spike in body temperature. Psychologically, high doses of stimulants can cause severe psychosis. MDMA overdoses have some similarities to stimulant overdoses, including increased body temperature, kidney failure, and hypertension. Alcohol overdoses most often occur when a person engages in binge drinking which can lead to breathing problems and interfere with cardiac functioning.
The Mechanics of an Overdose
Heart problems and oxygen deprivation are two common symptoms of an overdose that we see in many drug-related deaths. But what happens to the brain during an overdose? Are there lasting effects? Can an overdose cause permanent brain damage?
The body is being poisoned during an overdose, and it’s usually not obvious to the person who ingested the substance. Someone who has just taken a lethal amount of opioids is unlikely to recognize what’s happening, although others may. As described by Maggie Ethridge for Vice, signs include “extreme drowsiness, cold hands, cloudy thinking, nausea and/or vomiting, and especially slowed breathing (fewer than ten breaths per minute).”
Once ingested or injected, an opioid makes a beeline through your heart and into your lungs. While in the lungs, your blood gets a dose of oxygen and that “now opioid-rich blood is pushed out to the rest of the body, where it plugs into the system of opioid receptors all over your body.” As the opioids enter the brain, they cause the neurotransmitter dopamine (the feel-good chemical) to overflow. That’s where the feeling of euphoria comes from. After repeated use, reaching that blissful state becomes harder, requiring increasingly larger doses of the same drug.
If you’ve overdosed, the next thing that will happen is that your brain’s basic systems that control breathing will be affected and your breathing will slow before stopping entirely. Circulatory functioning is next to be affected; your heart rate will slow as the opioid dampens neurological signaling in the brain. As your oxygen levels reduce, your heart begins having irregular rhythms and this can lead to a cardiac arrest.
Opioids are a depressant, decreasing heart rate and breathing. Overdosing on opioids essentially causes the central nervous system to go into such a depressed state that the body forgets to breathe. Without enough oxygen (hypoxia), the brain can become severely damaged. The longer someone goes without oxygen, the worse the damage can be.
Certain parts of the brain are more sensitive to the immediate effects of oxygen deprivation. The frontal lobe is particularly at risk of damage when experiencing anoxia (zero oxygen reaching the brain), resulting in problems with executive functioning. Executive functioning refers to a set of mental skills in the areas of working memory, inhibitory control, and cognitive flexibility. If a person experiencing an overdose has a seizure, this can cause further damage to the brain.
Toxic Brain Injury
Substance use disorders and brain injuries go hand in hand. An estimated 25 percent of people who enter brain injury rehabilitation have had problems with drug use and half of people entering substance use treatment have experienced a brain injury. Each of these conditions makes the other worse.
Toxic brain injury is a term that has been coined to encapsulate the type of injuries that occur after an opioid overdose. It is also referenced under the category of acquired brain injuries, which include instances of brain damage that occur after someone is born but are not connected to degenerative or congenital diseases.
The white matter of the brain can sustain damage from repeated oxygen deprivation. The consequences of toxic brain injury increase if someone experiences multiple non-fatal opioid overdoses. Despite what we know about how overdoses can kill, there is scant literature regarding chronic health outcomes for people who have survived multiple overdoses. What research does exist focuses on brain injuries due to hypoxia/anoxia.
From what we do know, certain areas of the brain are most likely to be harmed and can “lead to the development of severe disability.” These areas affect neurological processes; short-term memory loss, disorientation, even acute amnesia have been observed. Survivors may develop physical problems such as loss of control over bodily functions, lack of coordination, nerve damage and subsequent reduction in the ability to use a certain limb or body part, or even paralysis. Less severe but still serious symptoms include slower reaction times, motor skill disturbances, memory problems, and overall “diminished physical functioning.”
Medical Treatment
Only 3 out of 10 people who overdose on opioids and survive seek medical treatment for addiction. For every reported overdose death, there “may be five nonfatal overdoses, many of which go unreported.”
This isn’t to say that anyone who has ever survived an overdose has brain damage, but rather that more research and advocacy needs to focus on surviving overdoses and how to best move forward with healing and increasing rates of recovery.
NASHIA (National Association of State Head Injury Association) recommends that substance use disorder treatment services should be available and accessible for people who have sustained a brain injury. They also recommend that medical providers regularly screen patients for a history of brain injury and to ensure that people can receive treatment for any cognitive, behavioral, and/or physical disabilities due to a brain injury.
Reducing overdoses is a critical aspect of preventing these kinds of chronic injuries. Once a person has one overdose, they’re more likely to have another, and that likelihood increases with each overdose. When available and implemented, harm reduction principles work to reduce this likelihood and improve outcomes. There is no one-size-fits-all approach to recovery from substance use disorder that will work for everyone. Harm reduction strategies like widespread use of naloxone improve the long-term health effects of an overdose.
Even some of the newest, most expensive brand-name medicines have been plagued by quality and safety concerns during production, a Kaiser Health News analysis shows.
After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished.
“I voted ‘yes’ because, quite simply, this is a game changer,” National Institutes of Health hepatologist Dr. Marc Ghany said of Sovaldi, Gilead Science’s new pill designed to cure most cases of hepatitis C within 12 weeks.
Dr. Lawrence Friedman, a professor at Harvard Medical School, called it his “favorite vote” as an FDA reviewer, according to the transcript.
What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against approval.
They issued a scathing 15-item disciplinary report after finding multiple violations at Gilead’s main U.S. drug testing laboratory, down the road from its headquarters in Foster City, Calif. Their findings criticized aspects of the quality control process from start to finish: Samples were improperly stored and catalogued; failures were not adequately reviewed; and results were vulnerable to tampering that could hide problems.
Gilead Foster City doesn’t manufacture drugs. Its job is to test samples from drug batches to ensure the pills don’t crumble or contain mold, glass or bacteria, or have too little of an active antiviral ingredient.
Recent news reports have focused public attention on poor quality control and contamination in the manufacturing of cheap generic drugs, particularly those made overseas. But even some of the newest, most expensive brand-name medicines have been plagued by quality and safety concerns during production, a Kaiser Health News analysis shows.
More disturbing, even when FDA inspectors flagged the potential danger and raised red flags internally, those problems were resolved with the agency in secret ― without a follow-up inspection ― and the drugs were approved for sale.
Erin Fox, who purchases medicines for University of Utah Health hospitals, said she was shocked to hear from KHN about manufacturing problems uncovered by authorities at the facilities that make brand-name products. “Either you’re following the rules or you’re not following the rules,” Fox said. “Maybe it’s just as bad for branded drugs.”
The pressure to get innovative drugs like Sovaldi into use is considerable, both because they offer new treatments for desperate patients and because the medicines are highly profitable.
Against that backdrop, the FDA has repeatedly found a way to approve brand-name drugs despite safety concerns at manufacturing facilities that had prompted inspectors to push to reject those drugs’ approval, an ongoing KHN investigation shows. This happened in 2018 with drugs for cancer, migraines, HIV and a rare disease, and 10 other times in recent years, federal records show. In such cases, how these issues were discussed, negotiated and ultimately resolved is not public record.
For example, inspectors found that facilities making immunotherapies and migraine treatments didn’t follow up when drug products showed evidence of bacteria, glass or other contaminants. At a Chinese plant making the new HIV drug Trogarzo, employees dismissed “black residue” found to be “non-dissolvable metal oxides,” assuming it “did not pose a significant risk,” federal records show.
Without a follow-up inspection to confirm drugmakers corrected the problems inspectors found, these medicines eventually were approved for sale, and at list prices as high as $189,000 a month for an average patient, according to health data firm Connecture. The cancer drug Lutathera was initially rejected over manufacturing problems at three plants but was approved a year later without a fresh inspection and was priced at $57,000 per vial.
John Avellanet, a consultant on FDA compliance, said data integrity problems, like those at Gilead’s lab in Foster City, should have sparked further investigation, because they raise the possibility of “deeper issues.”
Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said an inspector’s recommendation to withhold approval can be “dealt with” without a follow-up. Woodcock said the agency can’t comment on specifics, and companies are reluctant to discuss them because the details of the resolution are protected as a corporate trade secret.
“That doesn’t mean that there’s anything wrong with the drug,” Woodcock said.
Dinesh Thakur, a former drug-quality employee turned whistleblower, called the secrecy a “red flag.” A follow-up inspection is critical, he said: “I’ve seen many times paper commitments are made but never followed through.”
What worries Fox is that a faulty drug could get through and nobody would know.
“In general, very few people suspect that their medicine is the problem or their medicine is not working,” Fox said. “Unless you see black shavings or something horrible in the product itself, the drug is almost the last thing that would be suspect.”
The Market Beckons
If the FDA finds problems at preapproval inspections for generics, the agency is likely to deny approval and delay the drug’s launch until the next year’s review cycle, according to industry and agency experts.
In fact, just 12% of generics were approved the first time their sponsors submitted applications from 2015 through 2017.
The calculus appears different for heralded new therapies like Sovaldi. In 2018, 95% of novel drugs ― the newest of the new ― were approved on the first try, the FDA said.
Woodcock said the agency has “the same standards for all drugs,” but she emphasized that many of the manufacturing issues “are somewhat subjective.”
For new brand-name drugs, she said, the FDA “will work very closely with the company to … bring the manufacturing up to snuff.”
The manufacturer submits written responses and commits to resolve quality concerns, but the details are kept confidential.
An estimated 2.4 million Americans have hepatitis C and, before Sovaldi, treatment came with miserable side effects and a strong chance it wouldn’t work. Sovaldi promised up to a 90% cure rate, though it came with an eye-popping $84,000 price tag for a 12-week course, putting it out of reach for most patients and health care systems.
But corporate pressure to get such therapies into the marketplace is also considerable.
Pharmaceutical firms pay hefty fees for FDA review and lobby the agency to speed products to market. For Gilead, time lost is money.
“If approval of sofosbuvir were delayed, our anticipated revenues and our stock price would be adversely affected,” Gilead wrote in an SEC document filed Oct. 31, 2013, using the generic name for Sovaldi.
Since its debut in 2013, Sovaldi has been widely criticized for its price but recognized as a medical breakthrough. Gilead has never recalled it.
However, hundreds of patients who have taken the drug have voluntarily reported cancer or other complications to the FDA’s “adverse event” reporting database, including concerns that the treatment doesn’t always work. One in 5 Sovaldi patients and health care professionals who reported serious problems to federal regulators said the drug didn’t cure the patients’ hepatitis C.
“The FDA approved these products after a rigorous inspection process, and we are confident in the quality/compliance of these products,” Gilead spokeswoman Sonia Choi said.
Problems at Foster City
Gilead’s Foster City facility has been cited for an array of problems over the years. In 2012, FDA inspectors said the facility had failed to properly review how the HIV drugs Truvada and Atripla became contaminated with “blue glass” particles; some of that tainted batch was distributed. The company “made no attempt to recover” the contaminated drugs, according to FDA inspection records.
Gilead had just filed its application for Sovaldi’s approval when FDA inspectors arrived at Foster City for an unrelated inspection in April 2013. Inspectors slapped the facility with nine violations in what’s called a 483 document and said that the reliability of the site’s methods for testing things like purity were unproven and that its records were incomplete and disorganized, according to FDA inspection documents.
As a result, the FDA initially rejected two HIV drugs, Vitekta and Tybost. Gilead had to resubmit those applications, and it would take 18 months before the FDA approved them in late 2014.
On Sept. 19, 2013, FDA officials met to discuss Sovaldi with Woodcock, agency records show. Meeting minutes show inspectors recommended hitting Gilead Foster City with a formal warning letter based on the April inspection. (A warning letter is a disciplinary action from the FDA that typically includes a threat to withhold new approvals or place a foreign facility on import alert and refuse to accept its products for sale in the U.S.)
At the same meeting, FDA inspectors said their recommendation to approve Sovaldi would be “based on” removing an unnamed drug ingredient manufacturer from the application and “a determination that Gilead Foster City has an acceptable cGMP [current good manufacturing practices] status.”
Records show the FDA didn’t issue a warning letter or otherwise delay the approval process when Foster City failed its inspection.
Instead, the Sovaldi preapproval inspection started four days later and lasted two weeks. At the end, inspectors issued Foster City another 483, this time with 15 violations, formally outlining problems and requiring a written plan to fix them. Inspectors said they couldn’t recommend Sovaldi’s approval.
FDA officials gave Gilead two options during an Oct. 29 teleconference: Remove Foster City, a “major testing site” for Sovaldi, from the application, and use a third-party contractor instead; or use Foster City but hire another firm to monitor the site and sign off on its testing work.
Gilead was optimistic. “Based on recent communications with the FDA, we do not expect these [inspection] observations to delay approval of sofosbuvir,” the company said in its Oct. 31 SEC filing.
Gilead chose to replace the Foster City plant with a contract testing site, federal records show. By December, Sovaldi was approved for distribution, and the company soon announced its $1,000-per-pill price tag.
Not Just Generics
Recent media reports, and the ongoing recall of the widely used blood pressure medicine valsartan, have led consumers ― and members of Congress ― to question whether generics are manufactured safely. Valsartan pills made in China and India were found to contain cancer-causing impurities.
Branded-drug quality, in large part, has been spared from congressional scrutiny. But many factories ― overseas and in the U.S. ― make branded and generic drugs.
In January 2018, FDA inspectors hit a Korean manufacturing plant that makes Ajovy, a migraine drug, with a warning letter. With the problems still unresolved in April, an agency reviewer recommended withholding approval. When they returned in July, inspectors wanted to give the plant the worst possible classification: “Official Actions Indicated.” Among other problems, inspectors found that glass vials sometimes broke during the manufacturing process and that the facility lacked protocols to prevent the particles from getting into drug products. The FDA’s Office of Manufacturing Quality eventually downgraded the inspection to just “Voluntary Actions Indicated.”
The drug was approved in September 2018 and priced at $690 a month. FDA records indicate no further disciplinary action was taken. Teva, the maker of Ajovy, did not respond to requests for comment.
Similarly, when FDA inspectors visited a contract manufacturing facility in Indiana used to make Revcovi, which treats an autoimmune disease, they noted that a redacted drug lot had failed a sterility test because the vials tested positive for a bacterium called Delftia acidovorans, which can be detrimental even in people with healthy immune systems, studies show. But the drug-filling machine stayed in use after the contaminant was discovered, the FDA determined. Inspectors recommended withholding approval.
The drug was approved in October 2018 even after another inspection turned up problems, with a list price of $95,000 to $189,000 per month for an average patient, according to health care data firm Connecture.
Revcovi’s manufacturer, Leadiant Biosciences, said through an outside public relations firm that its contract manufacturer’s written responses to the FDA observations were considered “adequate” by two FDA offices, adding, “We do not have any more information to share with you at this time as pharmaceutical manufacturing processes are confidential.”
Problems with drugs can take years to discover ― and then only after patients are injured. So, many health researchers say, more caution is warranted.
“They’re doing so few of these [FDA] inspections pre-market,” said Diana Zuckerman, president of the nonprofit National Center for Health Research. “The least they can do is listen to the ones they’re doing.”
This story was originally published at Kaiser Health News on November 5, 2019
Rehab? Safe injection sites? Sue Big Pharma? Find out how each of the Democratic presidential candidates plan to address and treat opioid use disorder, and which of these approaches are supported by evidence.
In the lead-up to the 2020 elections, the Journalist’s Resource team is combing through the Democratic presidential candidates’ platforms and reporting what the research says about their policy proposals. We want to encourage deep coverage of these proposals — and to do our part to help deter horse race journalism, which research suggests can lead to inaccurate reporting and an uninformed electorate. Our criteria for the proposals we’re covering is simple: We’re focusing on proposals that have a reasonable chance of becoming policy, and for us that means at least 3 of the 5 top-polling candidates say they intend to tackle the issue. Here we look at candidates’ proposals to address the opioid epidemic. Candidates are divided in their approaches; while nearly all favor increasing funding for and access to treatment for opioid use disorder, fewer candidates support harm reduction policy interventions, such as safe injection sites and needle exchanges. A few candidates incorporate broader criminal justice-level changes or physician-level interventions into their policy proposals.
Candidates favoring increased funding for and access to treatment
Access to treatment: Medication-assisted treatment is an evidence-based treatment for opioid use disorder; it has been shown to reduce the risk of overdose death for people who use opioids. Methadone, buprenorphine and naltrexone are types of medication-assisted therapy for opioid use disorder. These medications reduce symptoms of craving and withdrawal. A systematic review and meta-analysis of medication-assisted treatment find that people receiving such treatment were less likely to die of an overdose or other causes than their peers with opioid use disorder who did not receive medication-assisted treatment.
Harm reduction: Harm reduction initiatives attempt to reduce the risks associated with using drugs. Such initiatives include needle exchange programs, widespread distribution of the opioid overdose antidote naloxone and supervised injection facilities. Supervised injection facilities, also known as safe injection sites or supervised consumption facilities, are not legal in the U.S. They exist legally in other countries, such as Canada and Australia, however.
Several studies have demonstrated a positive link between safe injection site use and entry into treatment. Safe injection sites also provide benefits to people who use drugs in the form of sterilized equipment and supervision to mitigate the dangers of overdose.
Over a dozen studies have linked needle exchanges with lower rates of hepatitis C and HIV infection among people who inject drugs.
A systematic review of research on take-home naloxone programs, which provide people at risk of opioid overdose with kits including the antidote, concludes that “there is overwhelming support of take-home naloxone programs being effective in preventing fatal opioid overdoses.”
The pharmaceutical industry: Big Pharma’s role in marketing opioids spurred physicians to prescribe more opioids, research shows. This, in turn, fueled the opioid epidemic the country faces today. Policies targeted toward Big Pharma include proposals to hold industry players liable for their role in the opioid epidemic with criminal penalties and fines.
Decriminalization: The rationale behind decriminalization of the personal use of narcotics is that criminal penalties essentially criminalize substance use disorder. Proponents of decriminalization argue that such drug use should, instead, be met with evidence-based treatment. There is not much research on the effects of decriminalization because it’s rare. However, in 2001, Portugal decriminalized personal acquisition, possession and use of illicit drugs. Research indicates that drug-related deaths have fallen since the southwestern European country decriminalized illicit drugs.
Physician-level interventions: These interventions target prescriber behavior. Examples include physician education programs, guidelines or restrictions on the quantity of opioids physicians can prescribe, and prescription monitoring programs that allow physicians to view patients’ prescription history to avoid overprescribing or illegitimate prescribing. While education and prescribing policies have curtailed prescribing habits, prescription monitoring programs have been less successful, studies indicate.
Key context
In late 2017, the U.S. Department of Health and Human Services declared the nation’s opioid crisis a “public health emergency.” The problem has been building for over a decade, spurred by sharp increases in prescriptions for opioids, commonly used to treat both short-term and chronic pain.
About 233.7 million opioid prescriptions were filled each year, on average, from 2006 to 2017, according to a March 2019 study in JAMA Network Open that looks at opioid prescriptions filled in retail pharmacies across the U.S.
As opioid use and misuse has increased, deaths linked to the drugs have increased. In 2017, opioids were involved in 47,600 drug overdose deaths, accounting for nearly 70% of all overdose deaths nationwide that year.
Recent research
Access to treatment:
A review of randomized controlled trials comparing medication-assisted treatment of opioid use disorder to placebo or no medication finds that medication-assisted treatment “at least doubles rates of opioid-abstinence outcomes.”
A study of 151,983 adults in England treated for opioid dependence between 2005 and 2009 finds that the risk of fatal drug overdose more than doubled for individuals who received only psychotherapy compared with those who received medication-assisted treatment.
Harm Reduction:
Two reviews — one published in Drug and Alcohol Dependence in 2014, and one published in Current HIV/AIDS Reports in 2017 — indicate that supervised consumption facilities promote help people access treatment. The more recent review looks at 47 studies published between 2003 and 2017 on supervised drug consumption facilities. The authors find a handful of studies that demonstrate a positive link between safe injection site use and starting treatment.
One of these studies compared enrollment in detoxification programs among those who used Vancouver’s supervised injection facility the year before and after it opened in 2003. Researchers find the facility’s opening was linked to a 30% increase in detox program use, which, in turn, was linked to pursuing long-term treatment and injecting at the facility less often. A later study of the injection facility focused on use of detox services located at the facility. It finds that 11.2% (147 people) used these services at least once over the two years studied. The authors conclude that supervised injection facilities might serve as a “point of access to detoxification services.”
A 2006 study of 871 people who injected drugs finds no substantial increase in rates of relapse among former users before and after the Vancouver site opened. However, the researchers also find no substantial decrease in the rate of stopping drug use among current users before and after the site opened. Another study of 1,065 people at this facility published in 2007 finds that only one individual performed his or her first injection at the site.
Though supervised injection sites are illegal in the U.S., one opened underground in 2014. Researchers interviewed those who used the underground site during its first two years of operation and their findings were published in 2017 in the American Journal of Preventive Medicine. The site’s users were asked the same set of questions about their use patterns every time they injected drugs at the site. The authors conclude that the site offered several benefits, including safe disposal of equipment, unrushed injections and immediate medical response to overdoses. The authors add that if the site were sanctioned, it might be able to offer additional benefits, including health care and other services.
Big Pharma:
Research suggests that physicians targeted with marketing from pharmaceutical companies prescribe opioids at higher rates than doctors not exposed to their marketing.
Several studies use data from the Centers for Medicare and Medicaid Services’ Open Payments database, which tracks payments made by drug and medical device companies to physicians. That information is used to analyze how relationships between physicians and drug companies are linked to prescriptions written.
These studies define opioid-related payments as cash payments — for example, speaking fees associated with promoting a drug — and payments-in-kind — free meals pharmaceutical representatives provide to doctors’ offices, for instance. These studies find that physicians who receive opioid-related payments tend to prescribe more opioids.
A study in PLoS One from December 2018 looks at physicians who received opioid-related payments, some in 2014 and some in 2015, compared with doctors who never received such payments. The authors find that physicians who received opioid-related payments had a larger increase in the number of daily doses of opioids dispensed, as well as in total opioid expenditures, prescribing pricier opioids per dose.
Another study looking at the same data offers further detail. The study, published in Addiction in June 2019, focuses on 865,347 physicians across the country who filled prescriptions for Medicare patients from 2014 to 2016. “Prescribers who received opioid-specific payments prescribed 8,784 opioid daily doses per year more than their peers who did not receive any such payments,” the authors write.
Other research geographically links opioid marketing and opioid-related overdose mortality. The paper, published in JAMA Network Open in January 2019, analyzes county-level prescription opioid overdose deaths and county-level opioid marketing payments.
The authors find that deaths from prescription opioid overdoses increased with each standard deviation increase in opioid marketing as measured by dollars spent per capita, number of payments to physicians per capita and number of physicians receiving payments per capita. Standard deviation indicates the variation of a given value from the average. “Opioid prescribing rates also increased with marketing,” the authors write. They note that the higher prescription rate might be why overdose deaths increased.
Physician-level interventions:
An August 2018 study published in Science highlights the role physician education might play in addressing the nation’s opioid crisis. The intervention was simple: When a patient died of an opioid overdose, the county medical examiner sent the prescribing physicians a letter notifying them. The authors conducted a randomized trial of 861 physicians whose patients overdosed. The intervention group received the letter, which included a safe prescribing warning consisting of these recommendations:
Avoid prescriptions lasting for three consecutive months or longer and prescribe naloxone, an opioid overdose antidote.
The control group received no communication.
Physicians in the intervention group cut their opioid prescribing by 9.7% — as measured by milligram morphine equivalents in prescriptions filled — in the three months after the letter was sent. These physicians also started fewer patients on opioids and wrote fewer high-dose prescriptions than the control group.
Prescribing policies and guidelines also have successfully curbed physicians’ distribution of opioids.
In October 2017, the Michigan Opioid Prescribing Engagement Network released opioid prescribing guidelines for nine surgical procedures to clinicians participating in the Michigan Surgical Quality Collaborative, a statewide initiative to improve surgical care.
Researchers compared opioid prescribing before and after these guidelines were released, analyzing data from 11,716 patients across 43 hospitals collected from February 2017 to May 2018. They find that prescriptions declined, on average, from 26 pills to 18 pills per month after the guidelines were released.
Patients also took fewer of the pills they were prescribed. As measured by patient-reported survey data, opioid consumption following surgery dropped from 12 pills to nine, “possibly as a result of patients anchoring and adjusting their expectations for opioid use to smaller prescriptions,” explain the authors of the August 2019 New England Journal of Medicine study. Although patients received smaller prescriptions and used fewer pills after the guidelines were published, there were no substantial changes in the patients’ satisfaction and pain scores.
Similar to the study of Michigan’s opioid prescribing guidelines is a February 2018 study in the American Journal of Emergency Medicine that tracks the effects of an emergency department opioid prescribing policy. The policy resulted in declines in opioid prescriptions. Compared with the control emergency department, the two intervention hospitals had a more pronounced decline in opioid prescribing. The authors conclude that emergency department-based policies might help reduce opioid prescribing.
Prescription drug monitoring programs, which allow physicians to view patients’ prescription history to avoid overprescribing or prescribing opioids to people who don’t actually need them, have been shown to be less effective. A January 2018 study of national data published in Addictive Behaviors finds that there were not statistically significant differences in the likelihood that physicians would prescribe opioids for chronic pain when comparing states with prescription drug monitoring programs with those without.
Allison L. Pitt, Keith Humphreys and Margaret L. Brandeau. American Journal of Public Health, October 2019.
The gist: “Policies focused on services for addicted people improve population health without harming any groups. Policies that reduce the prescription opioid supply may increase heroin use and reduce quality of life in the short term, but in the long term could generate positive health benefits. A portfolio of interventions will be needed for eventual mitigation.”
Evan Wood, Mark W. Tyndall, Ruth Zhang, Jo-Anne Stoltz, Calvin Lai, Julio S.G. Montaner and Thomas Kerr. New England Journal of Medicine, June 2006.
The gist: A study of Vancouver’s supervised injection facility finds “an average of at least weekly use of the supervised injecting facility and any contact with the facility’s addictions counselor were both independently associated with more rapid entry into a detoxification program.”
Kora DeBeck, Thomas Kerr, Lorna Bird, Ruth Zhang, David Marsh, Mark Tyndall, Julio Montaner and Evan Wood. Drug and Alcohol Dependence, January 2011.
The gist: “These data indicate a potential role of SIF [supervised injecting facilities] in promoting increased uptake of addiction treatment and subsequent injection cessation.”
The gist: “Participants’ narratives indicate that attending InSite [Vancouver’s supervised injection facility] has had numerous positive effects in their lives, including changes in sharing behavior, improving health, establishing social support and saving their lives.”
Jo Kimber, Richard P. Mattick, John Kaldor, Ingrid Van Beek, Stuart Gilmour and Jake A. Rance. Drug and Alcohol Review, May 2009.
The gist: Researchers conducted 1.5-year study at a supervised injection site in Sydney. They find that 16% of clients at the site referred to treatment by health and social welfare professionals went on to receive it, leading the authors to conclude that the center “engaged injecting drug users successfully in drug treatment referral and this was associated with presentation for drug treatment assessment and other health and psychosocial services.”
M.-J.S. Milloy, Thomas Kerr, Ruth Zhang, Mark Tyndall, Julio Montaner and Evan Wood. Journal of Public Health, September 2012.
The gist: Many who use supervised injection facilities have the desire to access treatment. This study surveyed 889 people who were randomly selected to be surveyed at Vancouver’s supervised injection facility. “At each interview, ∼20 percent of respondents reported trying but being unable to access any type of drug or alcohol treatment in the previous 6 months,” the authors write. The main barrier to access, respondents said, was waiting lists for treatment.
Art Van Zee. American Journal of Public Health, February 2009.
The gist: In the first six years it was on the market, Purdue Pharma spent about six to 12 times more to promote OxyContin than it had to promote another long-lasting opioid. The paper describes various marketing strategies including promotional giveaways and Pharma-funded medical education programs.
Scott E. Hadland, Maxwell S. Krieger and Brandon D. L. Marshall. American Journal of Public Health, September 2017.
The gist: This study examines payments pharmaceutical companies make to physicians to market opioid products. The authors find that 375,266 opioid-related payments that weren’t related to research work were made to 68,177 physicians over the study period. The authors estimate that about 1 in 12 physicians in the U.S. received a payment from a pharmaceutical company to promote their opioid medications during the 29-month study period. The bulk of the money went toward speaking fees or honoraria, but the most common expense was food and beverages – 352,298 payments totaling $7,872,581.
Scott E. Hadland, Magdalena Cerdá, Yu Li, Maxwell S. Krieger and Brandon D. L. Marshall. JAMA Internal Medicine, June 2018.
The gist: “Whereas physicians receiving no opioid-related payments had fewer opioid claims in 2015 than in 2014, physicians receiving such payments had more opioid claims,” the authors write.
David W. Grant, Hollie A. Power, Linh N. Vuong, Colin W. McInnes, Katherine B. Santosa, Jennifer F. Waljee and Susan E. Mackinnon. Plastic and Reconstructive Surgery, July 2019.
The gist: Plastic surgery trainees were asked about their opioid prescribing education, factors contributing to their prescribing practices and what they would prescribe for eight different procedures. The authors find that, of the 162 respondents, 25% of U.S. plastic surgery trainees received opioid-prescriber education, compared with 53% of Canadian trainees. For all but one of the eight procedures, U.S. physicians prescribed significantly more morphine milligram equivalents than their Canadian counterparts.
This piece adheres to suggestions offered by the National Institute on Drug Abuse’s media guide, which recommends language that avoids the potentially stigmatizing term “addict” in the context of substance use. It states: “In the past, people who used drugs were called ‘addicts.’ Current appropriate terms are people who use drugs and drug users.”
*Dropped out of race since publication date.
This article first appeared on Journalist’s Resource on December 9, 2019 and is republished here under a Creative Commons license.
The U.S. presidential impeachment inquiry has added another layer of uncertainty to an already unstable situation that includes political polarization and the effects of climate change.
As a clinical psychologist in the Washington, D.C. area, I hear people report being stressed, anxious, worried, depressed and angry. Indeed, an American Psychological Association 2017 survey found that 63% of Americans were stressed by “the future of our nation,” and 57% by the “current political climate.”
Humans dislike uncertainty in most situations, but some deal with it better than others. Numerous studies link high intolerance of uncertainty to anxiety and anxiety disorders, obsessive-compulsive disorder, depression, PTSD and eating disorders.
While no one person can reduce the uncertainty of the current political situation, you can learn to decrease intolerance of uncertainty by implementing these scientifically sound strategies.
When unsure how to best proceed with a work assignment, you might either immediately seek help, over-research or procrastinate. As you prepare for the day, uncertainty about the weather or traffic is quickly short-circuited by checking a phone. Similarly, inquiries about family or friends’ whereabouts or emotions can be instantly gratified by texting or checking social media.
Tolerance for uncertainty is like a muscle that weakens if not used. So, work that muscle next time you face uncertainty.
Start gradually: Resist the urge to reflexively check your GPS the next time you are lost and aren’t pressured for time. Or go to a concert without Googling the band beforehand. Next, try to sit with the feelings of uncertainty for a while before you pepper your teenager with texts when he is running late. Over time, the discomfort will diminish.
2. Connect to a Bigger Purpose
Rita Levi-Montalcini was a promising young Jewish scientist when fascists came to power in Italy and she had to go into hiding. As World War II was raging, she set up a secret lab in her parents’ bedroom, studying cell growth. She would later say that the meaning that she derived from her work helped her to deal with the evil outside and with the ultimate uncertainty of whether she would be discovered.
Focusing on what can transcend finite human existence – whether it is religion, spirituality or dedication to a cause – can decrease uncertainty-driven worry and depression.
3. Don’t Underestimate Your Coping Ability
You might hate uncertainty because you fear how you would fare if things went badly. And you might distrust your ability to cope with the negative events that life throws your way.
It turns out that humans are generally resilient, even in the face of very stressful or traumatic events. If a feared outcome materializes, chances are you will deal with it better than you could now imagine. Remember that the next time uncertainty rears its head.
4. Bolster Resilience by Increasing Self-Care
You have probably heard it many times by now: Sleep well, exercise and prioritize social connections if you want to have a long and happy life.
Possibly the best tool for coping with uncertainty is making sure that you have an active and meaningful social life. Loneliness fundamentally undermines a person’s sense of safety and makes it very hard to deal with the unpredictable nature of life.
In spite of civilization’s great progress, the fantasy of humankind’s absolute control over its environment and fate is still just that – a fantasy. So, I say to embrace the reality of uncertainty and enjoy the ride.
There are programs designed to help families but many of them advocate “tough love” and aren’t terribly effective.
About ten years ago, I got one of those letters. It was painful to read it but once I had a drink, my pain turned into indignation. I folded the letter multiple times till it ended up a tiny square, which I shoved into a shoebox where it lives till this day, next to old birthday cards and love notes from exes. I’m talking about my first Intervention Letter.
If you’ve never gotten one of these, then you were probably not destroying your family’s life successfully enough! I’m kidding, of course, and not everyone gets an Intervention Letter; some of us also get a serious talking-to; most of us get ultimatums and threats; and all of us get tears. This is what it’s like to have a family while high or drunk. Not fun. But it’s even less fun for the families—they are some of the most tortured, miserable, angry, confused people entangled in their misery by love.
It’s no wonder that resentment is ever-present, fuelling many misguided attempts to help circumvent addiction. Why misguided? Because those attempts rarely get anyone better. And a person going to a rehab to please their loved ones has less of a chance of staying clean than a person going on her own account. On top of it, the families are still often left without any solid tactics in place on how to keep their loved one sober, how to prevent relapses, and how not to fall back into the muck of co-dependency. There are programs designed to help families but many of them advocate “tough love” and aren’t terribly effective. So Intervention Letters and ultimatums are common.
Instead of Ultimatums and Threats, Compassion
Fortunately, there might be a better way—specifically the CRAFT way. According to one definition, “Community Reinforcement and Family Training (CRAFT) teaches family and friends effective strategies for helping their loved one to change and for feeling better themselves. CRAFT works to affect the loved one’s behavior by changing the way the family interacts with him or her.” At first look, CRAFT’s techniques might appear contra-intuitive as a lot of its teachings seem to advocate dismissing the addictive behavior—complaining, arguments and demands are discouraged. In fact, on the cover of the popular book on CRAFT, Get Your Loved One Sober, the tagline reads “Alternatives to Nagging, Pleading, and Threatening.” Instead of tough love, CRAFT advocates gentle love—and that approach seems to be working.
According to one trial by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), CRAFT was more effective than Al-Anon and Johnson Institute Intervention. CRAFT had a 64 percent success rate of getting the person with addiction into treatment compared to 30 percent for Johnston Institute and 10 percent for Al-Anon. Johnson Institute is a model that’s based on confrontation that is supposed to motivate the person with addiction to enter treatment. Al-Anon, similar to CRAFT, teaches detachment with love, but it is also a 12-step-based program which includes the sometimes-problematic concept of Higher Power and advocates a certain kind of passivity, which might not be conductive to strengthening the very fragile fabric of families dealing with active addiction.
In contrast, CRAFT focuses on attending to your own needs along with steering the problem user toward treatment, which often happens organically as the patterns of interaction change. CRAFT’s mission is to help reduce the loved one’s alcohol and drug use, whether or not the loved one has engaged in treatment yet. CRAFT discourages enabling, encourages problem solving, employs reward systems and aims to empower the beaten-down, frustrated family members. CRAFT doesn’t approve of breaking the family apart and its goal is to not only keep it all intact but also get everyone better.
A family member who’s part of CRAFT is taught to change her/ his reactions—from negative to positive—in response to the triggers from the person with addiction. For example, a husband coming home late after a night of drinking with his buddies again won’t get a lecture for being late for dinner, as he usually does in that situation, because the wife will have been instructed to take care of her own needs, and she will have eaten the dinner on her own.
Observing and Adapting
As part of CRAFT, the family members are asked to observe and monitor the addictive behavior of their loved one—this means noting what situations might cause the person to reach for another drink, what creates conflict, and observing any patterns in behavior. With time, as these patterns become obvious, the family member changes the approach—from aggressive to more passive and compassionate—and in that more loving way, upsets the predictable trajectory of maladaptive interactions with the addicted person. Instead of yelling at someone and accusing her of being a liar, the family member might say, “I know you haven’t been going to work all this time and I am hurt that you’re lying to me. Let’s talk about it in the morning after you sleep it off.” A calm, reasonable way of dealing with the situation will most likely elicit a reaction that’s not combative. Eventually those kinds of interactions will become a norm and change will occur.
It’s not exactly “kill them with kindness” but it’s a similar principle. When you expect Intervention Letters—like I did—and you’re stuck in a hamster wheel of constant conflict, getting something completely opposite might just shock you into action. Receiving praise for sticking to commitments—even something as small as coming home on time—or staying sober for a string of days, is more effective than having those subtle changes ignored or taken for granted. No, we don’t need to applaud every nice thing a person with addiction does but in the beginning, perhaps it makes sense to do so. People who are just starting to get sober are very much like babies—deregulated emotions, lack of impulse control—and praise goes a longer way than punishment does. Punishment tends to prolong trauma where praise leaves the person wanting to earn it again, which leads to repeating the desirable action.
A Better Alternative to Tough Love
My family has always taken the “tough love” route and my addiction did contribute to me eventually separating from my husband. I imagine if we were a part of CRAFT program, things could’ve gone differently. I lived through ultimatums and anger and once I was kicked out of my house. I’ve often felt alone and ashamed and angry with myself for disappointing everyone. I thought I was worthless and my loved ones’ attitude confirmed that. But I don’t think they knew any better. So many of us with addiction still live in an episode of Intervention; we have never been shown a kinder, better way.
“if there is a disjunct between what the neuroscience shows and what the behavior shows, you’ve got to believe the behavior.”
8.30.2019
On March 30, 1981, 25-year-old John W. Hinckley Jr. shot President Ronald Reagan and three other people. The following year, he went on trial for his crimes.
Defense attorneys argued that Hinckley was insane, and they pointed to a trove of evidence to back their claim. Their client had a history of behavioral problems. He was obsessed with the actress Jodie Foster, and devised a plan to assassinate a president to impress her. He hounded Jimmy Carter. Then he targeted Reagan.
In a controversial courtroom twist, Hinckley’s defense team also introduced scientific evidence: a computerized axial tomography (CAT) scan that suggested their client had a “shrunken,” or atrophied, brain. Initially, the judge didn’t want to allow it. The scan didn’t prove that Hinckley had schizophrenia, experts said — but this sort of brain atrophy was more common among schizophrenics than among the general population.
It helped convince the jury to find Hinckley not responsible by reason of insanity.
Nearly 40 years later, the neuroscience that influenced Hinckley’s trial has advanced by leaps and bounds — particularly because of improvements in magnetic resonance imaging (MRI) and the invention of functional magnetic resonance imaging (fMRI), which lets scientists look at blood flows and oxygenation in the brain without hurting it. Today neuroscientists can see what happens in the brain when a subject recognizes a loved one, experiences failure, or feels pain.
Despite this explosion in neuroscience knowledge, and notwithstanding Hinckley’s successful defense, “neurolaw” hasn’t had a tremendous impact on the courts — yet. But it is coming. Attorneys working civil cases introduce brain imaging ever more routinely to argue that a client has or has not been injured. Criminal attorneys, too, sometimes argue that a brain condition mitigates a client’s responsibility. Lawyers and judges are participating in continuing education programs to learn about brain anatomy and what MRIs and EEGs and all those other brain tests actually show.
Most of these lawyers and judges want to know such things as whether brain imaging could establish a defendant’s mental age, supply more dependable lie-detection tests or reveal conclusively when someone is experiencing pain and when they are malingering (which would help resolve personal injury cases). Neuroscience researchers aren’t there yet, but they are working hard to unearth correlations that might help — looking to see which parts of the brain engage in a host of situations.
Progress has been incremental but steady. Though neuroscience in the courts remains rare, “we’re seeing way more of it in the courts than we used to,” says Judge Morris B. Hoffman, of Colorado’s 2nd Judicial District Court. “And I think that’s going to continue.”
A Mounting Count of Cases
Criminal law has looked to the human mind and mental states since the seventeenth century, says legal scholar Deborah Denno of Fordham University School of Law. In earlier centuries, courts blamed aberrant behavior on “the devil” — and only later, starting in the early twentieth century, did they begin recognizing cognitive deficits and psychological diagnoses made through Freudian analysis and other approaches.
Neuroscience represents a tantalizing next step: evidence directly concerned with the physical state of the brain and its quantifiable functions.
There is no systematic count of all the cases, civil and criminal, in which neuroscientific evidence such as brain scans has been introduced. It’s almost certainly most common in civil cases, says Kent Kiehl, a neuroscientist at the University of New Mexico and a principal investigator at the nonprofit Mind Research Network, which focuses on applying neuroimaging to the study of mental illness. In civil proceedings, says Kiehl, who frequently consults with attorneys to help them understand neuroimaging science, MRIs are common if there’s a question of brain injury, and a significant judgment at stake.
In criminal courts, MRIs are most often used to assess brain injury or trauma in capital cases (eligible for the death penalty) “to ensure that there’s not something obviously neurologically wrong, which could alter the trajectory of the case,” Kiehl says. If a murder defendant’s brain scan reveals a tumor in the frontal lobe, for instance, or evidence of frontotemporal dementia, that could inject just enough doubt to make it hard for a court to arrive at a guilty verdict (as brain atrophy did during Hinckley’s trial). But these tests are expensive.
Some scholars have tried to quantify how often neuroscience has been used in criminal cases. A 2015 analysis by Denno identified 800 neuroscience-involved criminal cases over a 20-year period. It also found increases in the use of brain evidence year over year, as did a 2016 study by Nita Farahany, a legal scholar and ethicist at Duke University.
Farahany’s latest count, detailed in an article about neurolaw she coauthored in the Annual Review of Criminology, found more than 2,800 recorded legal opinions between 2005 and 2015 where criminal defendants in the US had used neuroscience — everything from medical records to neuropsychological testing to brain scans — as part of their defense. About 20 percent of defendants who presented neuroscientific evidence got some favorable outcome, be it a more generous deadline to file paperwork, a new hearing or a reversal.
But even the best studies like these include only reported cases, which represent “a tiny, tiny fraction” of trials, says Owen Jones, a scholar of law and biological sciences at Vanderbilt University. (Jones also directs the MacArthur Foundation Research Network on Law and Neuroscience, which partners neuroscientists and legal scholars to do neurolaw research and help the legal system navigate the science.) Most cases, he says, result in plea agreements or settlements and never make it to trial, and there’s no feasible way to track how neuroscience is used in those instances.
The Science of States of Mind
Even as some lawyers are already introducing neuroscience into legal proceedings, researchers are trying to help the legal system separate the wheat from the chaff, through brain-scanning experiments and legal analysis. These help to identify where and how neuroscience can and can’t be helpful. The work is incremental, but is steadily marching ahead.
One MacArthur network team at Stanford, led by neuroscientist Anthony Wagner, has looked at ways to use machine learning (a form of artificial intelligence) to analyze fMRI scans to identify when someone is looking at photos they recognize as being from their own lives. Test subjects were placed in a scanner and shown a series of pictures, some collected from cameras they had been wearing around their own necks, others collected from cameras worn by others.
Tracking changes in oxygenation to follow patterns in blood flow — a proxy for where neurons are firing more frequently — the team’s machine-learning algorithms correctly identified whether subjects were viewing images from their own lives, or someone else’s, more than 90 percent of the time.
“It’s a proof of concept, at this stage, but in theory it’s a biomarker of recognition,” Jones says. “You could imagine that could have a lot of different legal implications” — such as one day helping to assess the accuracy and reliability of eyewitness memory.
Other researchers are using fMRI to try to identify differences in the brain between a knowing state of mind and a reckless state of mind, important legal concepts that can have powerful effects on the severity of criminal sentences.
To explore the question, Gideon Yaffe of the Yale Law School, neuroscientist Read Montague of Virginia Tech and colleagues used fMRI to brain-scan study participants as they considered whether to carry a suitcase through a checkpoint. All were told — with varying degrees of certainty — that the case might contain contraband. Those informed that there was 100 percent certainty that they were carrying contraband were deemed to be in a knowing state of mind; those given a lower level of certainty were classified as being in the law’s definition of a reckless state of mind. Using machine-learning algorithms to read fMRI scans, the scientists could reliably distinguish between the two states.
Neuroscientists also hope to better understand the biological correlates of recidivism — Kiehl, for instance, has analyzed thousands of fMRI and structural MRI scans of inmates in high-security prisons in the US in order to tell whether the brains of people who committed or were arrested for new crimes look different than the brains of people who weren’t. Getting a sense of an offender’s likelihood of committing a new crime in the future is crucial to successful rehabilitation of prisoners, he says.
Others are studying the concept of mental age. A team led by Yale and Weill Cornell Medical College neuroscientist B.J. Casey used fMRI to look at whether, in differing circumstances, young adults’ brains function more like minors’ brains or more like those of older adults — and discovered that it often depended on emotional state. Greater insight into the brain’s maturation process could have relevance for juvenile justice reform, neurolaw scholars say, and for how we treat young adults, who are in a transitional period.
The Jury Is Still Out
It remains to be seen if all this research will yield actionable results. In 2018, Hoffman, who has been a leader in neurolaw research, wrote a paper discussing potential breakthroughs and dividing them into three categories: near term, long term and “never happening.” He predicted that neuroscientists are likely to improve existing tools for chronic pain detection in the near future, and in the next 10 to 50 years he believes they’ll reliably be able to detect memories and lies, and to determine brain maturity.
But brain science will never gain a full understanding of addiction, he suggested, or lead courts to abandon notions of responsibility or free will (a prospect that gives many philosophers and legal scholars pause).
Many realize that no matter how good neuroscientists get at teasing out the links between brain biology and human behavior, applying neuroscientific evidence to the law will always be tricky. One concern is that brain studies ordered after the fact may not shed light on a defendant’s motivations and behavior at the time a crime was committed — which is what matters in court. Another concern is that studies of how an average brain works do not always provide reliable information on how a specific individual’s brain works.
“The most important question is whether the evidence is legally relevant. That is, does it help answer a precise legal question?” says Stephen J. Morse, a scholar of law and psychiatry at the University of Pennsylvania. He is in the camp who believe that neuroscience will never revolutionize the law, because “actions speak louder than images,” and that in a legal setting, “if there is a disjunct between what the neuroscience shows and what the behavior shows, you’ve got to believe the behavior.” He worries about the prospect of “neurohype,” and attorneys who overstate the scientific evidence.
Some say that neuroscience won’t change the fundamental problems the law concerns itself with — “the giant questions that we’ve been asking each other for 2,000 years,” as Hoffman puts it — questions about the nature of human responsibility, or the purpose of punishment.
But in day-to-day courtroom life, such big-picture, philosophical worries might not matter, Kiehl says.
“If there are two or three papers that support that the evidence has a sound scientific basis, published in good journals, by reputable academics, then lawyers are going to want to use it.”
10.1146/knowable-082919-1
Eryn Brown is a freelance writer and editor whose work has appeared in the Los Angeles Times, the New York Times, Nature, and other publications. Reach her at [email protected].
This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.
Traumatic events that military personnel experience, even among those who don’t serve directly on the front lines, can increase opioid misuse, according to the paper.
United States military service members who experience combat are more likely to misuse prescription painkillers than those who don’t engage in combat, according to a new working paper from the National Bureau of Economic Research.
Prescription painkiller misuse is 7 percentage points higher among service members whose units were deployed to combat zones and engaged with enemy fighters, compared with those deployed to combat zones whose units didn’t engage the enemy, the authors find.
“This study is the first to estimate the causal impact of combat deployments in the Global War on Terrorism on opioid abuse,” the authors write.
They also find that younger, enlisted personnel are at greater risk for misusing prescription painkillers after combat exposure. Service members in the authors’ sample come from similar socioeconomic backgrounds. This suggests the association is driven by what happens on the battlefield, not other factors like race, ethnicity and income levels that have been broadly linked to opioid misuse.
“Among military populations, combat is a very major reason for the opioid epidemic,” says Resul Cesur, an associate professor of healthcare economics at the University of Connecticut and one of the paper’s authors. “It’s not because of who these people are. It’s because of what they are being exposed to.”
The authors conservatively estimate that government health care costs top $1 billion per year to treat active-duty service members and veterans who misuse prescription painkillers.
While not all prescription painkillers are opioids, oxycodone, hydrocodone and other opioids are among those prescription painkillers generally most likely to be misused — compared with painkillers like nonsteroidal anti-inflammatory drugs, which typically aren’t thought to be addictive.
“For this reason, I think these [prescription painkiller data] are very good proxies for what we want to capture,” Cesur says.
Combat exposure is also associated with higher rates of heroin use, according to this paper. Looking at a different dataset, the authors find deployed service members who saw combat used heroin at a 1.4 percentage point higher rate than deployed service members who didn’t engage with enemy fighters. The authors identified the largest effects among service members in the Army, Marines and Navy, relative to service members in the Air Force. The government cost of treating active-duty service members and veterans who misuse heroin is nearly $500 million per year, the authors conservatively estimate.
Enlisted Personnel Bear the Brunt
The U.S. military has two distinct career tracks: enlisted personnel and commissioned officers. One of those tracks bears the brunt of the opioid crisis in the military, this research finds.
Enlisted personnel perform tasks. They usually receive specialized training, and their specialties can vary widely. Enlisted personnel may scout a battlefield, or service biomedical equipment, or care for government-owned animals or perform any number of other specialties. A four-year degree is not required to enlist.
Commissioned officers serve primarily as management. They handle operations and strategy and give orders to lower-ranked officers and enlisted personnel. Each branch of the military has slightly different paths toward becoming an officer, but most include having or obtaining a four-year college degree.
In addition to having more formal education, officers also typically earn more money than enlisted personnel.
Enlisted personnel account for nearly all of the association between combat exposure and painkiller misuse, the authors find. Of the nearly 2.8 million service members who have served overseas since 9/11, 86% were enlisted, according to a 2018 analysis by the RAND Corporation.
“We find the effects among officers are almost zero,” Cesur says. Younger enlisted service members, age 18 to 24, who saw combat are also more likely to have misused painkillers, the authors find.
Data Sources
The authors draw their findings from two surveys of military service members.
The first is the National Longitudinal Study of Adolescent and Adult Health, also called Add Health. This nationally representative survey originally interviewed about 20,000 adolescents in grades 7-12 during the 1994-1995 school year. Researchers asked about kids’ social and economic backgrounds, their performance in school and their psychological and physical well-being. They followed up with the original respondents during 2007-2008.
From Add Health, the authors analyzed a sample of 482 men aged 28 to 34 who reported actively serving in the military during the Iraq and Afghanistan wars in the early- and mid-2000s. Detailed socioeconomic information allowed the authors to study respondents who had similar upbringings. This sample led to the finding that prescription painkiller misuse was 7 percentage points higher among service members whose units were deployed to combat zones and engaged with enemy fighters.
The other, much larger sample was the 2008 Department of Defense Health and Related Behaviors Survey. This survey included nearly 30,000 active-duty service members aged 18 to 50. The authors’ sample included responses from 11,542 soldiers deployed overseas who provided information on recent prescription painkiller misuse. Respondents were also asked about other illicit drug use.
This sample led to the finding that heroin use is higher among service members who experience combat, and to the broader finding that enlisted personnel account for almost all of the link between combat exposure and painkiller misuse.
Men made up more than three-fourths of enlisted personnel who saw combat and responded to the DOD survey. Before 2013, women were not allowed to take up many frontline positions.
Injury, Easy Supply and Peers
The authors reason that soldiers might start using opioids for their original medical purpose: when warzone service members are injured, opioids can help manage their pain.
Post-traumatic stress disorder also explains a big chunk of the relationship between combat exposure and painkiller abuse, Resul says. Traumatic events that military personnel experience, even among those who don’t serve directly on the front lines, can increase opioid misuse, according to the paper. In the authors’ DOD survey sample, 10% of active-duty deployed service members had PTSD.
Another reason for opioid misuse among military personnel who saw combat could be that cheap, high-quality opioids were available in the very places service members were deployed in the 2000s. Opium poppy cultivation in Afghanistan grew steadily in the years after 9/11, according to data from the United Nations Office on Drugs and Crime.
“Opium production in Iraq was much rarer than in Afghanistan, but production in Iraq began to grow in the aftermath of Operation Iraqi Freedom,” the authors write. “Production appears to have accelerated during the period just before and during the so-called ‘surge’ of U.S. Armed Forces to Iraq in 2007-2008.”
There may also be peer effects at play.
“People go to combat zones and then see their colleague is using opioids because he is stressed,” Cesur says. “So that may be another pattern. Humans are social creatures and we copy from each other.”
Veterans at Risk
Programs aimed at reducing painkiller prescriptions to soldiers and veterans appear, so far, to be working.
Opioid prescriptions from Department of Veterans Affairs doctors fell more than 40% from 2012 to 2017, according to the authors. This coincides with the VA’s Opioid Safety Initiative, which began in 2013 and aims to educate healthcare providers on the benefits and risks of prescribing opioids.
The authors note that, “the reduction in opioid prescriptions to curb abuse may have the unintended consequence of reduced pain abatement for opioid users who do not suffer from addiction,” and that “sudden negative shocks to prescription painkillers could induce veterans to more dangerous, and perhaps deadly, forms of opioid use such as heroin or fentanyl if these drugs are substitutes.”
Despite fewer painkiller prescriptions, the opioid overdose death epidemic among veterans is still very real — and appears to be getting worse. After troop surges in Afghanistan and Iraq in the late 2000s, opioid use disorders among veterans rose 55%, according to data the authors cite from the VA.
Veterans broadly are twice as likely to die from accidental drug overdoses, according to one widelyandrecently cited study analyzing data from 2005 and published in 2011 in the journal Medical Care.
More recent research in the American Journal of Preventive Medicine bolsters the premise that veterans remain particularly vulnerable to addiction. The rate of opioid overdose deaths among veterans in 2016 increased 65% from 2010, according to that paper — even as the percentage of veterans who received prescriptions for opioids in the three months before their deaths fell from 54% in 2010 to 26% in 2016.
The authors of the new NBER paper cite evidence suggesting that medical marijuana could be an effective substitute for opioids in treating chronic pain. Medical marijuana may not play a straightforward role in easing the broader opioid epidemic, however. Research in the Proceedings of the National Academy of Sciences from just a few months ago found — contrary to prior research — that opioid overdose death rates increased by nearly a quarter in states with legal medical marijuana.
Even taking benzodiazepines in adherence to a prescribing physician’s instructions can lead to dependence.
May 30, 2019 This tip sheet, originally published in 2018, has been updated to include more recent statistics and additional information.
Benzodiazepines, a class of anti-anxiety drugs, are commonly-prescribed medications with the potential for abuse, addiction and overdose. Sound familiar? The parallels to the opioid epidemic are apparent; some physicians have taken to calling it “our other prescription drug problem” as they warn of potential dangers.
“People don’t appreciate that benzodiazepines are addictive and that people abuse them,” said Dr. Anna Lembke, a psychiatry professor at Stanford Medical School. In a phone call with Journalist’s Resource, she said that, just as with alcohol, benzodiazepines can be taken to achieve a state of intoxication.
Lembke is the program director for the Stanford University Addiction Medicine Fellowship and chief of the Stanford Addiction Medicine Dual Diagnosis Clinic. She has published research in JAMA Psychiatry, Molecular Psychiatry, the Journal of Substance Abuse Treatment, Addiction and other journals. In 2016 she published Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop, a book on the prescription drug epidemic. Journalist’s Resource spoke with Lembke to learn more about the drugs and factors that have spurred current prescribing trends.
For context, a few recent studies put numbers to these trends: A new study that focuses on Sweden finds that benzodiazepines and benzodiazepine-related drug prescriptions increased 22 percent from 2006 to 2013 among individuals aged 24 and younger.
A study published in 2016 in the American Journal of Public Health finds that from 1996 to 2013, the number of adults in the United States filling a prescription for benzodiazepines increased 67 percent, from 8.1 million to 13.5 million. The death rate for overdoses involving benzodiazepines also increased in this time period, from 0.58 per 100,000 adults to 3.07.
What Are Benzodiazepines?
Benzodiazepines are a class of drugs with sedative and anti-anxiety effects. A few of the most commonly prescribed benzodiazepines include diazepam (brand name: Valium), alprazolam (brand name: Xanax; street names: bars, xannies), clonazepam (brand name: Klonopin) and lorazepam (brand name: Ativan). These drugs differ with respect to how long they take to start working and how long they last, but all have similar effects, since they work by the same mechanism.
How Do They Work?
Benzodiazepines bind to gamma-aminobutyric acid (GABA) receptors in the brain. GABA is an inhibitory neurotransmitter; in other words, it inhibits brain activity. Turning the power down in the brain feels like sleepiness and calm.
What Are They Prescribed For?
They can be prescribed for a number of concerns, including anxiety, insomnia and seizures.
How Can They Be Dangerous?
Benzodiazepines are accompanied by a number of side effects, including tolerance (reduced sensitivity) for the drug, cognitive impairment, anterograde amnesia (the inability to remember events that occurred after taking the drug), increased risk of Alzheimer’s disease, increased risk of falls (particularly among the elderly, who, according to a study in JAMA Psychiatry, comprise the age group in the U.S. most likely to use the drugs, and use them over the long term), and, most notably, dependence, abuse and overdose. Benzodiazepines are similar to opioids, cannabinoids, and the club drug gamma-hydroxybutyrate (GHB) insofar as the same neural mechanism underlies their addictiveness, according to research published in Nature.
Even taking benzodiazepines in adherence to a prescribing physician’s instructions can lead to dependence. Withdrawal symptoms are likely among patients who have taken benzodiazepines continuously for longer than a few weeks, according to a study published in Australian Prescriber.
For people who are looking to discontinue their use of benzodiazepines, Lembke noted that withdrawal could be potentially life threatening. “You can have full-blown seizures and die just from the withdrawal,” she said.
“The way that they’re prescribed and continued is contrary to the evidence in the medical literature,” Lembke said. She noted that the evidence indicates benzodiazepines are effective and useful only in the short term, and typically at low doses. “There’s no evidence that benzodiazepines taken long term work for anxiety,” she said. “Nonetheless, it is common practice to prescribe and continue those prescriptions for months to years to decades. Somehow there’s a disconnect between the evidence and what the practice is.”
Given These Risks, Why Are Prescriptions on the Rise?
“No one knows for sure,” Lembke said. She did, however, offer a few possible explanations.
She mentioned changes over the past three decades in the way healthcare is delivered.
As more physicians have shifted from private practice into integrated health care centers, they might feel pressure to adhere to standard protocols or perform procedures and prescribe pills like benzodiazepines, because “that’s what pays.”
She added that the way medicine is currently practiced separates patients into parts: “Patients have a different doctor for every body part … The right hand doesn’t know what the left hand is prescribing.”
Frequent changes in insurance coverage, or churn, means that individuals bounce from one coverage source (and care provider) to another. This eliminates the possibility of a sustained, caring and trusting relationship that might allow for more efficacious, long-term health interventions, Lembke added.
Other changes to the health care system have also occurred: “In many ways, doctors are like waiters and patients are customers,” Lembke explained, adding that some doctors feel the need to respond to patients’ requests and provide short-term relief or “customer satisfaction.”
A cultural shift might be at work here, too, “Patients expect it,” Lembke said. “We now think pain in any form is dangerous … We’ve also got a whole generation of individuals raised on Prozac, Adderall, Xanax thinking there isn’t anything wrong with using chemicals to change the way you feel.”
Benzodiazepines and Opioids
As Lembke pointed out, rising pharmaceutical use isn’t limited to benzodiazepines. And as the United States grapples with widespread opioid use, research points to a dangerous link between these drugs and benzodiazepines.
A study of over 300,000 patients receiving opioid prescriptions between 2001 and 2013 finds that by 2013, 17 percent also received benzodiazepine prescriptions — up from 9 percent in 2001.
Moreover, a study that looked at U.S. veterans who received opioid prescriptions finds that those who received benzodiazepines as well experienced increased risk of drug overdose death; the risk increased along with the dose. Another study finds that the overdose death rate among patients receiving opioids and benzodiazepines was 10 times higher than among those receiving opioids alone.
According to statistics from the National Institute of Drug Abuse (NIDA), from 1999 to 2017, there was a 10-fold increase in the number of overdose deaths involving benzodiazepines in the United States — a rise from 1,135 in 1999 to 11,537 in 2017. Most of the increase has been driven by the use of benzodiazepines in combination with opioids (since 2014, the number of overdose deaths involving benzodiazepines but not any opioids has held steady). As opioids contribute increasingly to benzodiazepine overdose deaths, benzodiazepines too are increasingly present in opioid overdose deaths — the powerful combination of drugs is present in over 30 percent of opioid overdoses, NIDA reports.
Benzodiazepine abuse on its own can lead to overdose and death, but overdose deaths typically occur in combination with other substances — generally other central nervous system depressants, which, like benzodiazepines, can lead to the life-threatening effect of slowed or stopped breathing.
Probe Big Pharma’s role in prescription trends and look at socioeconomic variations in benzodiazepine prescriptions (e.g., Medicaid prescribing rates).
Journalist’s Resource also has explainers on other drugs, including fentanyl and meth.
This photo, property of the United States Department of Justice, was obtained from Wikimedia Commonsand used under a Creative Commons license.
