The Laws You Never Heard Of that Will Help to Fight the Opioid Epidemic

When a politician is in his or her final few month in office (because either they lost their re-election or simply decided not to or can’t run), they call this the “lame duck” period. President Obama’s last few months in office were anything but “lame”.

On December 14, 2016, in a rare move of bipartisanship, Obama signed into law the massive 21st Century Cures Act. This law provides a boost in funding for NIH (which includes $1.8 billion for the cancer moonshot initiative), changes to the drug approval process through the FDA, and ambitious mental health reform. This huge bill has the stated purpose of “To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.”

I’m willing to bet many people were totally unaware of this legislation that could help millions. There are some parts that are controversial and, as with any large piece of legislation, some provision that benefit this interest or that have been worked in (the changes to drug approval at the FDA will likely benefit Big Pharma). I’m not a health policy expert so I’m not about to go through and discuss line-by-line the winners and losers in this law (if you want a more in depth discussion: NPR, Washington Post, and PBS have all written articles on the law).

There’s one piece of the law that I am particularly thrilled about: $1 billion over 2 years for treatment for opioid addiction. That’s rights billion, with a “B”. The money is to be distributed to states in the form of block grants (block grants are in essence a large allocation of federal money to be used for a specific purpose given to states but the details of how that money is used is decided by the states themselves).

This is an unprecedented amount of funding earmarked exclusively to fight the opioid epidemic that is still raging in the US. The funding is to be used for expanding and increasing accessibility to treatment, such as life saving medication-assisted treatments such as methadone and buprenorphine. The federal money will also be used to train healthcare professionals to better care for people dealing with addiction, and a comparatively smaller amount for conducting research on how best to fight the epidemic, and other provisions.

I’ve written about methadone and buprenorphine and their effectiveness ad nauseam on this site and I am personally and thrilled to see a massive federal effort to increase access to these vital tools in the fight against the opioid crisis

The Cures Act comes on the heels of another promising piece of legislation, the Comprehensive Addiction and Recovery Act (CARA), signed into law by President Obama on July 13, 2016. This law includes provisions to expand the availability of naloxone–the medication used to save people from the effects of opioid overdose–to first responders, improve prescription drug monitoring programs, make it easier for healthcare providers to administer, dispense, or prescribe medication-assisted treatments, and other provisions.

The combination of these two pieces of legislation is a promising and much needed initial federal response.

However, this huge boost in funds for treatment in the Cures Act is only for 2-years. President Trump’s budget for FY18 would add $500 million for opioid addiction but most analysts think this is just a sneaky way of making it seem as if he’s supporting addiction treatment when the money has already been written in as part of the Cures Act. Further, his cuts to the Department of Health and Human Services (which contains the NIH and other agencies that administer the Cures and CARA laws) would make it difficult to launch any type of  effective response to the crisis.

Regardless of how things shake out, Trump’s massive cuts for everything that’s not the Department of Defense will likely hurt the fight against the opioid epidemic too. The real question is by how much?

 

The Science of Sexual Orientation

(from psychologicalscience.org)
(from psychologicalscience.org)

Happy New Year!

I figure I’ll kick things off with something a little different than my usual science of addiction posts.

My new job deals with supporting LGBT rights in the developing world and there’s a lot of work be done! In fact, as of June 2016, 77 countries or territories criminalize homosexuality and 13 countries or territories penalize homosexual behavior by death. But why is this? Why is someone who is attracted to and has sex with someone of the same sex so controversial in so much of the world? Well..I’m not about to begin to answer that question because I’ll be writing all week (hint, hint: religion is a huge factor).

Instead, I’ll present some of the key findings from a relatively new (April 2016) review article about the science of sexual orientation by JM Bailey and colleagues in the journal Psychological Science in the Public Interest. This is by far one of the most comprehensive and most even handed review articles written on the subject. The authors take an extremely academic approach because let’s face, the science surrounding sexual orientation has been used and abused by both pro- and anti- gay rights folks. (note: this article does not really discuss with transgenderism or gender identity issues)

This article is too long to go into all the details so instead I’m just going to present the main highlights that I prepared for a research report a few months back. Enjoy!

Download the article here. It’s Open Access!

jm-bailey-et-al-2016

Brief Summary:

Political controversies pertaining to the acceptance of non-heterosexual (lesbian, gay, bisexual) orientation often overlap with controversies surrounding the science of sexual orientation. In an attempt to clarify the erroneous use of scientific information from both sides of the debate, this article 1) provides a comprehensive review of the current science of sexual orientation, and 2) considers the relevance of scientific findings to political discussions on sexual orientation.

Top Takeaways from the Review:

  • The scientific evidence strongly supports non-social versus social causes of sexual orientation.
  • The science of sexual orientation is often poorly used in political debates but scientific evidence can be relevant to specific, limited number of issues that may have political consequences.
(wikimedia.org)
(wikimedia.org)

The scientific evidence strongly supports non-social versus social causes of sexual orientation (nature vs nurture).

Prevalence of non-heterosexual orientation (analysis of 9 large studies): 5% of U.S. adults.

Summary of the major, scientifically well-founded findings supporting non-social causes:

  • Gender non-conformity during childhood (before the onset of sexual attraction) strongly correlates with non-heterosexuality as an adult.
  • Occurrence of same-sex behavior has been documented in hundreds of species and regular occurrence of such behavior in a few species (mostly primates, sheep).
  • Reported differences in the structure of a specific brain region (SDN-POA) between heterosexual and homosexual men.
  • Hormone-induced changes in the SDN-POA during development in animal studies and subsequent altered adult sexual behavior (the organizational hypothesis).
  • Reports of males reared as females but who exhibit heterosexual attractions as adults.
  • Twin studies suggest only moderate genetic/heritable influence on sexual orientation.
  • Several reports identify a region on the X chromosome associated with homosexuality.
  • The most consistent finding is that homosexual men tend to have a greater number of biological older brothers than heterosexual men. (fraternal-birth-order effect)

The science of sexual orientation is often poorly used in political debates, but scientific evidence can be relevant to a specific, limited number of issues that may have political consequences.

The question of whether sexual orientation is a “choice” is logically and semantically confusing and cannot be scientifically proven. It should not be included in political discussions.

Examples of scientifically reasonable questions include:

  • Is sexual orientation determined by non-social (genetic/hormonal/etc.) or social causes? (nature vs nurture)
  • Is sexual orientation primarily determined by genetics or environment?

Specific cases in which scientific evidence can be used to inform political decisions:

  • The belief that homosexual people recruit others to homosexuality (recruitment hypothesis). This type of belief was espoused by by President Museveni of Uganda in 2014 and was used to justify Uganda’s notorious anti-homosexuality bill (since repealed).
    • No studies exist that provide any type of evidence in support of this hypothesis.
  • Proponents of conversion/reparative “therapies” argue that sexual orientation can be changed through conditioning and reinforcement.  Gov. and VP-elect Mike Pence  allegedly supported these types of bogus “therapies” in Indiana.
    • Studies reporting successful “conversion” suffer from methodological errors such as selection bias and/or unreliable self-report data and are therefore scientifically unfounded.
    • No evidence exists that a person’s sexual orientation can be changed at will.

 

The British Medical Journal (BMJ) Calls for an End to the “War on Drugs”

war-on-drugs-no

A recent editorial in the British Medial Journal (the BMJ) has called for an end to the “War on Drugs”, which costs about $100 Billion/year and has failed to prevent both drug use and drug proliferation.

The article points out how the “War on Drugs”, the term used to collectively describe the laws penalizing drug use, has had a wide-range of negative effects. For example, the US has the highest incarceration rate in the world and about half of those arrests are due to drug-related arrests.

The health effects have been drastic as well. Stigma against opioid replacement therapies like methadone has resulted in increased deaths due to opioid overdose in countries that limit access. Stigma and discrimination against addicts, as well of fear of punishment for for usage, often leads away from health care services to unsafe drug-use practices that can spread HIV and Hepatitis C, and other unintended poor-health outcomes.

Importantly, the editors call for rational, evidence-based, drug-specific approach to regulation and strong involvement of  the scientific and medical communities. Obviously, the risks of something like marijuana are much lower than for heroin but how will drug policy reflect this? Research is required to support any efforts in order to identify the best practices and strategies.

The editors point out that a recent article in the Lancet “concluded that governments should decriminalise minor drug offences, strengthen health and social sector approaches, move cautiously towards regulated drug markets where possible, and scientifically evaluate the outcomes to build pragmatic and rational policy.”

Above all, a change in drug policy must benefit human health and there will be no “one size fits all” approach. The road ahead is difficult but one thing is certain, the road that led us here is a dead end. The “War on Drugs” has failed; the call now is to develop a national and international drug policy that won’t.

The Consequences of Childhood Abuse Last Until Adulthood: What are the Implications for Society?

(© Derek Simon 2015)
(© Derek Simon 2015)

One of the great questions in the addiction field is why do some people become full-blown addicts while other people can use drugs occasionally without progressing to anything more serious? One part the answer definitely has to do with the drug itself. For example, heroin causes a more intensely pleasurable high than cocaine and people that try heroin are more likely to become addicted to it than cocaine. But that’s not the whole story.

I’ve written previously about how a negative, stressful environment can have long-lasting negative impacts on the development of a child’s brain (also known as early-life stress of ELS). ELS such as childhood abuse (physical or sexual) and neglect can increase the risk for a whole host of problems as an adult such as depression, bipolar disorder, PTSD, and of course drug and alcohol abuse. There’s even a risk for more physical ailments like obesity, migraines, cardiovascular disease, diabetes, and more.

Childhood abuse/neglect = psychological and physical problems as an adult.

Attitudes towards childhood development have certainly changed! Child coal miners ca. 1911 (wikipedia.org).
Attitudes towards childhood development have certainly changed! Child coal miners ca. 1911 (wikipedia.org).

This idea doesn’t sound too controversial but believe it or not, the idea that a bad or stressful situation as a child would do anything to you as an adult was laughed away as not possible. It’s only within the last decade or so that a wealth of research has supported this idea that ELS can physically change the brain and that these changes can last through the abused child’s entire life.

This recent review paper (published in the journal Neuron) is an excellent, albeit technical, summary of dozens research papers done on this subject and the underlying biology behind their findings.

Paradise lost childhood abuse review 2016 title

I especially love the quotes the author included at the beginning of the article:

Paradise lost childhood abuse review 2016 quotes

And even more recently, yet another research paper has come out that highlights how important childhood is for the development of the brain and how a stressful childhood environment can impact the function of a person as an adult.

Childhood abuse paper 2016

This most recent report, published in the journal Neuropscyhopharmacology concludes that early childhood abuse affects male and females differently. That is to say that the physical changes that occur in the brain are distinct for men and women who were abused as children.

Studies like this one are done by examining the brains of adults who were abused as kids and then comparing the activity or structure of different parts of the brain to the brains of adults who were not abused. The general technique of examining the structure or activity of the brain in a living human being is called neuroimaging and includes a range of techniques such as MRI, PET, fMRI, and others. (I’ve written about some of these techniques before. In fact, the development of better methods to image the brain is a huge are of research in the neuroscience field).

However, this study did not examine behavioral differences in the subjects, but as I said above, a great number of many other studies have looked at the psychological consequences of ELS. But this paper is really primarily interested in the gender differences in the brains of adults that have been abused as kids.

*Note: the following discussion is entirely my own and is not mentioned or alluded to by the author’s of this study at all.

This work—and the many studies that preceded it—has important implications because as a society, we have to realize that part of our personality/intelligence/character/etc. is determined by our genetics while the other part totally depends on the environment we are born into. I don’t want to extrapolate too much but the idea that childhood abuse can increase the risk of psychological problems as an adult also supports the broader notion that a great deal of a person’s success is determined by entirely random circumstances.

The_ACE_Pyramid
The Adverse Consequences Pyramid perfectly illustrates how ELS/abuse/neglect (the bottom of the pyramid) leads to much greater problems in later life. (wikimedia.org).

The science shows that a child born into a household rife with abuse will have more chance of suffering from a psychological problem (such as addiction) as an adult than someone who was born into a more stable life. The psychological problem could hurt that person’s ability to study in school or to hold down a job. And the tragic irony, of course, is that no child gets to choose the conditions under which they are born. A child, born completely without a choice of any kind over whether or not he or she will be abused, can still suffer the consequences of it (and blame for it) as an adult.

As a society, we often always blame a person’s failures as brought on by his or her own personal failings, but what if a person’s childhood plays an important role in why that person might have failed? How, as a society, do we incorporate this information into the idea of ourselves as having complete control over our minds and our destinies, when we very clearly do not? As an adult, how much of a person’s personality is really “their own problem” when research like this clearly show that ELS impacts a person well after the abuse has ended?

If the environment a child is born into has a tangible, physical effect on how the brain functions as an adult, than this problem is more than a social or an economic one: this is a matter of public health. Studies that support findings such as these provide empirical significance for public policy and public services for child care such as universal pre-K, increased availability of daycare, health insurance/medical access for children, increased and equitable funding for all public schools regardless of the economic situation of the district that school happens to be located in, etc.

One of our goals as a society (if indeed we believe ourselves to be a functioning society…the success of Donald Trump’s candidacy raises some serious doubts…but I digress) is the improvement of the lives of ALL of our citizens and securing the prosperity of the society for future generations. Reducing childhood poverty and abuse quite literally could help secure the future generations themselves and improve the ability of any child to grow up to become a successful and productive adult.

Public programs are essential because the unfortunate reality for many people born into poverty is that they must work all the time at low paying jobs in order to simply survive and may not be able to give their children all the advantages of a wealthier family. And this is where government and public policy step in, to correct the imbalances and unfairness inherent to the randomness of life and level the playing field for all peoples. Of course, the specific programs and policies to reduce childhood poverty and abuse would need to be evaluated empirically themselves to guarantee an important improvement in development of the brain and health of the child when he/she grows up.

And this is the real power of neuroscience and basic scientific research papers like this one. Research into how our brains operate in real-life situations reveal a side of our minds and our personalities that we never may have considered before and the huge implications this can have for society. The brain is a complex machine and just like other machines it can be broken.

Of course, we shouldn’t extrapolate too much and say that, for example, a drug addict who was abused as a child is not responsible for anything they’ve ever done in between. But is important to recognize all the mitigating factors at play in a person’s success and simply dismiss someone’s problems as “their own personal responsibility.” As a neuroscientist, I might argue that that phrase and the issues behind it are way more nuanced than the how certain politicians like to use it.

Special endnote Due to some recent shifts in my career, Dr. Simon Says Science will be expanding the content that I write about. Addiction and neuroscience will still be prominently featured but I plan to delve into a variety of other topics that I find interesting and sharing opinions that I think are important. I hope you will enjoy the changes! Thanks very much!

 

What is naloxone? Should it be available over the counter?

Naloxone_(1)

New blog post for addictionblog on naloxone, an antidote for opioid overdoses.

Read my post at addictionblog here!

 

 

The CDC Fights Back Against the Opioid Epidemic

2000px-US_CDC_logo.svg

The CDC has released important information on dealing with the prescription opioid pain medication and heroin epidemic. Opioids are a class of drugs that include pain medications such as morphine, oxycodone, hydrocodone, methadone, fentanyl and others and the illegal drug heroin. I’ve spoken a great deal about this problem in various other posts (see here here here and especially here and here). Just to summarize some of most disturbing trends: the US is experiencing a surge in deaths due to overdose on opioids (overdoses/year due to opioids are now greater than fatalities from car crashes), virtually all demographics (age groups, income levels, gender, race) are affected, and many people addicted to opioid pain pills transition to heroin and as such, a huge increase in heroin abuse is also occurring; teenagers and adolescents are especially hard hit. The CDC’s report, released on Friday, March 18 provides a thorough review of the clinical evidence around prescription opioid pain medications and makes 12 recommendations to help control the over-prescription of these powerful drugs in attempt to reduce the amount of overdose deaths and addiction.

Read the full report.

I finally got around to reading the whole thing and am happy to summarize its main analyses and findings. While the report is intended for primary health care providers and clinicians, the report’s findings are important for anyone suffering from short or long-term pain and the risks vs benefits posed by opioids.

But before I dive into the meat of the report, I wanted to clarify an important issue about addiction to prescription opioids. A false narrative exists that those suffering from addiction are “drug seekers” and it is this group of people that is duping doctors in prescribing them too many opioids while good patients that take opioids as directed are not over dosing or becoming addicted. It’s important to remember that opioids are so powerful anyone that takes them runs the risk of overdosing or becoming addicted after repeated use. Most people suffering from addiction and overdoses during the current prescription opioid epidemic are people that used opioids medically and not for recreation. This is true for youths prescribed opioids for a high-school sports injury, and older patients prescribed opioids for chronic back pain, and many other “regular” people. The CDC released this report to help fight back against the over-prescription of opioids and the severe risks that accompany their use. Doctors and patients alike need to be aware of the risks vs benefits of opioids if they decide to use them for pain therapy.

Hydrocodone (wikimedia.org)
Hydrocodone (wikimedia.org)

The CDC’s report had three primary goals:

  1. Identify relevant clinical questions related to prescribing of opioid pain medications.
  2. Evaluate the clinical and contextual evidence that addresses these questions
  3. Prepare recommendations based on the evidence.

Two types of evidence were used in preparation of the report: direct clinical evidence and indirect evidence that supports various aspects of the clinical evidence (contextual evidence). Studies included in the analysis ranged from high quality randomized control studies (the gold standard for evaluating clinical effectiveness) to more observational studies (not strong, direct evidence but useful information nonetheless).

The report identified five central questions regarding the concerns over opioids:

  1. Is there evidence of effectiveness of opioid therapy in long-term treatment of chronic pain?
  2. What are the risks of opioids?
  3. What differences in effectiveness between different dosing strategies (immediate release versus long-acting/extended release)?
  4. How effective are the existing systems for predicting the risks of opioids (overdose, addiction, abuse or misuse) and assessing those risks in patients?
  5. What is the effect of prescribing opioids for acute pain on long-term use?

Based on a close examination of the clinical evidence from a number of published studies, the CDC found the following answer to these questions.

  1. There is no evidence supporting the benefits of opioids at managing chronic pain. Opioids are only useful for acute (less than 3 days) pain and for cancer pain or end-or-life pain treatment.
  2. Opioids have numerous risks such as abuse and addiction, overdose, fractures due to falling in some older patients, car crashes due to impairments, and other problems. The longer opioids are used the greater these risks.
  3. There is no difference in effectiveness between immediate release opioids and long-acting or extended release formulation. The evidence suggests the risk for overdose is greater with long-acting and extended-release opioids.
  4. No currently available monitoring methods or systems are capable of completely predicting or identifying risk for overdose, dependence, abuse, or addiction but severak methods may be effective at helping to evaluate these risk factors.
  5. The use of opioids for treating acute pain increases the likelihood that they will be sued long-term (most likely because of tolerance and dependence).
Oxycodone (wikimedia.org)
Oxycodone (wikimedia.org)

The CDC also examined what they called contextual evidence or studies that didn’t directly answer the primary clinical questions but still provided valuable, if indirect, information about treatment of pain with/without opioids.

  • Non-medication based therapies like physical therapy, exercise therapy, psychological therapies, etc. can be effective at treating chronic pain for a number of conditions.
  • Non-opioid pain medications such as acetaminophen, NSAIDs, Cox-2 inhibitors, anti-convulsants, and anti-depressants (in some instances) were also effective in treating chronic pain for various conditions and have fewer dangers than opioids.
  • Long-acting opioids increase the risk for overdose and addiction. Higher doses of opioids also increase the risk for overdose.
  • Co-prescription of opioids with benzodiazepines greatly increases the risk of overdoses.
  • Many doctors are unsure of how to talk to their patients about opioids and their benefits vs risks and most patients don’t know what opioids even are.
  • The opioid epidemic costs billions of dollars in medical and associated costs. Its estimated  costs due to treatment of overdose alone is $20.4 billion.

Many other findings and important pieces are information were reported but too many to list here.

Based on all results of the analysis the CDC came up with 12 recommendations in three broad categories. I’ll briefly discuss each recommendation.

Category 1: Determining when to initiate or continue opioids for chronic pain.

  • Recommendation 1: Non-pharmacologic (medication-based) therapy and non-opioid pharmacologic therapy are preferred for chronic pain.
    • The risks of overdose and addiction from long-term use of opioids is very high and benefits for actually treating pain are very low for most people. Therefore, other safer and more-effective treatments should be use first. The discussion of the risks vs benefits needs to be made clear by the patient’s doctor.
  • Recommendation 2: Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function
    • Opioids should be used for the shortest amount of time possible but if used for a long-term treatment, at the lowest effective dose.
    • If a patient suffers from an overdose or seems as if dependence or addiction is developing, a patient may need to be tapered off of opioids.
  • Recommendation 3: Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy.
    • The risks are high for the use of opioids and it is necessary for doctors to keep their patients informed about these risks.
    • Doctors should be “be explicit and realistic about expected benefits from opioids, explaining that while opioids can reduce pain during short-term use, there is no good evidence that opioids improve pain or function with long-term use, and that complete relief of pain is unlikely.”

Category 2: Opioid selection, dosage, duration, follow-up, and discontinuation.

  • Recommendation 4: When starting opioid therapy, clinicians should prescribe immediate-release opioids instead of extended-release or long-acting opioids.
    • There appears to be no difference in effectiveness at treating pain between the different types of opioids but the long-acting opioids come with a greater risk for overdose and dependence.
    • Long-acting opioids should be reserved for cancer pain or end-of-life pain.
    • It’s important to note that “abuse-deterrent” does not mean that there is no risk for abuse, dependence, or addiction. These types of formulations are generally to prevent intravenous use (shooting up with a needle) but most problems with opioids occur as a result of normal, oral use.
  • Recommendation 5: When opioids are started, clinicians should prescribe the lowest effective dosage.
    • The higher the dose the greater the risk. A low dose may be sufficient to control the pain without risk for overdose or the development of dependence.
    • Opioids are often most effective in the short-term and may not need to be continued after 3 days.
    • If dosage needs to be increased, changes in pain and function in the patient should be re-evaluated afterwards to determine if a benefit has occurred.
    • Patients currently on high-dose long-term opioids for chronic pain may want to consider tapering down their dosage.
      • Tapering opioids can be challenging can take a long-time due to the physical and psychological dependence. Tapering should be done slowly to and the best course of dosage should be determined specifically for the patient.
    • Recommendation 6: Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed.
      • Evidence suggests that using an opioid for acute pain can start a patient down a path of long-term use. This should attempted to be avoided by using a low dose if opioid is selected to treat acute pain.
      • Acute pain can often be effectively managed without opioids with non-medication-based therapies (like exercise, water aerobics, physical therapy, etc.) or non-opioid medications (like acetaminophen or NSAIDs).
    • Recommendation 7: Clinicians should evaluate benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation.
      • Opioids are most effective for the first three days and possible up to a week. If long-term therapy is decided upon, treatment should regularly be reassessed and reevaluated (at least every 3 months for long-term therapy).

Category 3: Assessing risks and addressing harms of opioid use.

  • Recommendation 8: Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone.
    • Specific risk factors for the specific condition that patient is using opioids for should be considered when developing the treatment plan.
    • Naloxone blocks the effects of opioids and can immediately revive someone that has experienced an overdose. Naloxone should be offered to patients if a patient is using opioids at high-dose for long-term therapy or previously suffered an overdose.
  • Recommendation 9: Clinicians should review the patient’s history of controlled substance prescription using state prescription drug monitoring program (PDMP) data to determine whether a patient is receive opioid dosages or dangerous combinations that put him or her at risk for overdose.
    • PDMPs are state-run databases that collect information on controlled prescription drugs dispensed by pharmacies and in some states, physicians too.
    • While the clinical evidence was unclear if PDMPs were accurate at predicting overdose or addiction, the contextual evidence supported that “most fatal overdoses were associated with patients receiving opioids from multiple prescribers and/or with patients receiving high total daily opioid dosage.”
    • PDMP should be consulted before beginning opioid therapy and during the course of treatment if used for long-term therapy and this data should be discussed with the patient.
    • However, PDMP data must be used cautiously as some patients are turned away from treatment that would otherwise have benefited.
  • Recommendation 10: (not a general recommendation but to be considered on a patient-by-patient basis) When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
    • Urine drug tests can reveal information about potential risks due to combinations with other drugs not reported by the patient (e.g. benzodiazepines, heroin).
    • Urine testing should become standard practice and should be done prior to starting opioids for chronic therapy.
    • Clinicians should make it clear that testing is intended for patient safety and is not intended to deprive the patient of therapy unnecessarily.
  • Recommendation 11: Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
    • Strong evidence suggests that many overdoses occurred in patients prescribed both benzodiazepines and opioids. The two should never be prescribed together if at all possible.
  • Recommendation 12: Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid abuse disorder (addiction).
    • Many patients using opioids for chronic pain now may have become physically and psychologically addicted to them and should be offered treatment (estimated at 3-26% of patients using opioids for chronic pain therapy).
    • Methadone and buprenorphine are proven, safe, and effective-treatments that retain patients in treatment and that satisfy an opioid addict’s cravings, prevent relapse to abusing opioids/heroin, and allow the patient to live a normal life (read my blog post on methadone).
    • Behavioral therapy/individual counseling in combination with medication-based treatment may improve positive benefits of treatment even further.
    • However, access to these medications can be extremely limited in some communities due to availability (methadone is restricted to clinics and clinicians need certification in order to prescribe buprenorphine) or cost (treatment often is not covered by insurance).
    • Urine testing or PDMP data may help to reveal if a patient has become addicted and if so, treatment should be arranged.

In Summary, the main takeaways from the report are:

  • Opioids are associated with many risks such as overdose, abuse, dependence, addiction, and others (e.g. fractures from falling or car-crashes due to impairment).
  • No evidence exists that opioids are effective for treatment of chronic pain (with the exception of cancer and end-of-life pain).
  • Opioids are most effective for short term (3-7 days) and in immediate-release formulations.
  • Non-medication based therapies and non-opioid medications are preferred for treatment of chronic pain.
  • Doctors need to clearly explain the risks vs benefits of opioid therapy with their patients.
  • If decided as the best course of action for a particular patient, opioid therapy needs to be repeated re-evaluated to make sure it is still working to alleviate pain.
  • The prescription drug monitoring programs are useful tools that should be consulted prior to beginning therapy in order to help determine a patient’s history with opioids and risk for abuse or overdose.
  • Naloxone should be made available to patients using opioids for long-term therapy in order to prevent possible overdoses.
  • Access to medication-based treatments (methadone or buprenorphine) for dependent individuals should be provided.

Concluding Thoughts

In 1995 Purdue pharmaceuticals released OxyContin (oxycodone, one of the most common prescription opioid pain medications) and launched an enormous push for doctors to use opioids as the primary treatment for chronic pain. The enormous surge in in prescriptions of oxycodone (500% increase from 1999-2011) followed this marketing campaign. One of the most disturbing aspects revealed by the CDC’s report is that despite this surge in prescriptions, there is a complete lack of data on the effectiveness of opioids for long-term chronic pain therapy.

To be fair though, “Big Pharma” is not the sole culprit in this crisis. One argument is that pharma was responding to the need of clinicians for an increased demand by patients for management of chronic pain. It is very disturbing though that the push for the use of opioids for long-term management was initiated without any supporting evidence. This is another example of how medicine must be guided by evidence-based principles and not on personal beliefs and values or medical tradition and culture.

It’s important to remember that some patients do tolerate opioids well and these patients may find them beneficial at treating their chronic pain condition. The guidelines do stress frequent reevaluation of the benefits vs risks of opioids and for some patients benefits will outweigh the risks.

Finally, the CDC’s guidelines are not legally binding. These are recommendations and not laws or regulations. This means no doctors are not legally required to comply with any of the CDC’s recommendations. Hopefully some or all of these recommendations will be formalized into formal laws and regulations because many of them are extremely important in regulating these powerful and potentially dangerous drugs.

(Also check out the Diane Rehm Show’s hour-long discussion of the report. As usual, the show offers a high quality analysis and discussion from a panel of experts.)

Top Scientific Leaders on Addiction Call for its Treatment as a Medical Disease

(© Alan Cleaver flickr https://www.flickr.com/photos/alancleaver/4104954991)
(© Alan Cleaver flickr https://www.flickr.com/photos/alancleaver/4104954991)

A new review article published in the prestigious New England Journal of Medicine highlights the importance of treatment of addiction as a medical disease and calls for a change in public health policy towards addiction. Written by several leaders in the addiction field including Nora Volkow, MD, the director of NIDA, and George Koob, PhD, the director of NIAAA, the article does a superb job at outlining the underlying biology of addiction and clearly explains why addiction is a disease of the brain that needs to be treated medically.

Read the full article here.

In fact, I also covered most of the points made in the article in my own post for Addiction Blog on “Why Addiction is a Brain Disease?”

However, when it comes to public health policy towards addiction, this is where the article fell short. While treatments for opioid addiction such as methadone and buprenorphine were briefly mentioned in the article, there was no call for a national effort to be made to increase access to these vital medications. The authors had a potential to increase awareness of the opioid epidemic and the treatments already on hand to fight it but failed to make a stronger case for this critical improvement.

Nevertheless, the article is well written and a great introduction to the neuroscience of addiction and why it is a disease of the brain.

Presidential Candidates Support an End to Addiction Stigma

(© Alan Cleaver flickr https://www.flickr.com/photos/alancleaver/4104954991)
(© Alan Cleaver flickr https://www.flickr.com/photos/alancleaver/4104954991)

Something remarkable is occurring in the way politicians are speaking about addiction (I’ve written about this previously). The discussion has shifted to focus on addiction as a disease and addicts as human beings requiring treatment, opposed to addicts as criminals requiring punishment or incarceration. Importantly, this shift away from the “war on drugs” rhetoric reaches across the political spectrum.

During the Democratic presidential debate held in December, Bernie Sanders called addiction “a disease and not a criminal activity” while Hilary Clinton and Martin O’Malley expressed similar sentiments.

New Hampshire, a state that has been particularly hard hit by the opioid epidemic sweeping the nation, recently held an Addiction Policy Forum at Southern New Hampshire University. Several GOP candidates attended the forum, including Jeb Bush, Chris Christie, Carly Fiorina, and John Kasich. The candidates spoke personally about addiction, humanized addicts, and referred to addiction as a disease. Particularly moving was Carly Fiorina’s tragic story regarding her step-daughter’s struggle with addiction.

Despite these encouraging remarks, no candidate at the forum issued a call to increase accessibility to medication-assisted treatment of addiction.

NPR’s report on the forum offers an important analysis that I had not previously considered. One reason why the attitude in addiction is changing may be that the current opioid epidemic effects affects nearly every strata of society, including every race, whereas other drug epidemics in the past (such as the crack cocaine epidemic of the 80s and 90s) primarily affected only minority communities. NPR reports that some people refer to this as “the gentrification of the drug crisis.”

Even GOP candidate John Kasich of Ohio said, “This disease knows no bounds, knows no income, knows no neighborhood, it’s everywhere. And sometimes I wonder how African-Americans must have felt when drugs were awash in their community and nobody watched. Now it’s in our communities, and now all of a sudden we’ve got forums, and God bless us, but think about the struggles that other people had.”

A more political spin on the recent trend posted on the Hill blog discusses the rise of the “recovery voter”, an increasingly vocal group of people that place addiction as their number one issue. Clearly the presidential candidates are responding to the call for increasing governmental action on addiction.

I am cautiously optimistic about these positive trends but will reserve judgment until either Democratic or Republican candidates outline specific policy details.

Personality-targeted Interventions Can Reduce Alcohol and Marijuana Use Among Adolescents

Cover-Photo-for-Conrod-post

Let me state the obvious: alcohol and marijuana are the two most widely used drugs of abuse in the United States. According to the annual National Survey on Drug Use and Health (NSDUH), (the most comprehensive survey of drug use and abuse in the United States conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA)) as of 2013, 86.8% of the population aged 18 or older have reported having consumed alcohol during their lifetime with over 16.6 million adults diagnosed with alcohol abuse disorder.

Of course, we all know the prevalence and extent of underage drinking, and the damage alcohol has on the developing brain has been heavily researched, not to mention all the significant secondary problems associated with alcohol abuse (car crashes, sexual assault on college campuses, falling off of balconies… ).

But here’s some numbers anyways: as of 2013, 8.7 million youths aged 12-20 reported past month alcohol use, a shockingly high number for an age group this is not legally allowed to drink alcohol…

Similarly, marijuana, which is still illegal in the vast majority of the US, is nearly as ubiquitous. According to the NSDUH 2013 survey, 19.8 million adults aged 18 or older reported past month marijuana use.

And with marijuana legalization in Colorado and Washington, a significant concern raised by many is that abuse of the drug among youths will dramatically increase even higher than it is now. The research supporting the damage marijuana can inflict on brain development is also significant.

But what if the risk of use of alcohol and marijuana by youths could be reduced? What if a teacher could be given the tools to not only identify certain risky personality traits in their students but also use that knowledge to help those at-risk students from trying and using drugs such as alcohol and marijuana? A series of studies coming out of the laboratory of Dr. Patricia A Conrod of King’s College London report having done exactly that.

SFN 2015 LogoI had the pleasure of seeing Dr. Conrod speak at the recent Society for Neuroscience Conference as part of a satellite meeting jointly organized by the National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA). Dr. Conrod presented a compelling story spanning over a decade of her and her colleague’s work, in which certain personality traits amongst high risk youths, can actually be used to predict drug abuse amongst those kids. Dr. Conrod argues that by identifying different risk factors in different adolescents, a specific behavioral intervention can be designed to help reduce alcohol drinking and marijuana use in these youths. And who is best to administer such an intervention? Teachers and counselors, of course: educators that spend a great deal of time interacting with students and are in the best position to help them.

The Teacher-Delivered Personality Targeted Interventions For Substance Misuse Trial, also known as the Adventure Trial, was conducted in London during 2008-2009 and the results were first published in 2010.

This ambitious study recruited 2,643 students (between 13 and 14 years old) from 21 secondary schools in London (20 of the 21 schools were state-funded schools). Importantly, this study was a cluster-randomized control trial, which means the schools were randomly assigned to two groups: one group received the intervention while the other did not. The researchers identified four personality traits in high-risk (HR) youths that increase the risk of engaging in substance abuse. The four traits are:

  1. Anxiety sensitivity,
  2. Hopelessness
  3. Impulsivity
  4. Sensation seeking.

A specific intervention based on cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) was developed to target each of these personality traits. Teacher, mentors, counselors, and educational specialists in each school that were recruited for the study were trained in the specific interventions. In general, CBT is an approach used in psychotherapy to change negative or harmful thoughts or the patient’s relationship to these thoughts, which in turn can change the patient’s behavior. CBT has been effective in a treating a number of mental disorders such anxiety, personality disorders, and depression. MET is an approach used to augment a patient’s motivation in achieving a goal and has mostly been employed in treating alcohol abuse.

The CBT and MET interventions in this study were designed to target one of the four personality traits (for example, anxiety reduction) and were administered in two 90-minute group sessions. The specific lesson plans for these interventions were not reported in the studies but included workbooks and such activities as goal-setting exercises and CBT therapies to help students to dissect their own personal experiences through identifying and dealing with negative/harmful thoughts and how those thoughts can result in negative behaviors. Interestingly, alcohol and drug use were only a minor focus of the interventions.

The success of the interventions was determined through self-reporting. The student’s completed the Reckless Behavior Questionnaire (RBQ), which is based on a six-point scale (“never” to “daily or almost daily”) to report substance use. Obviously due to the sensitive nature of these questionnaires and need for honesty by the students, measures were taken to ensure accuracy in the self-reporting, such as strong emphasis on the anonymity and confidentiality of the reports and inclusion of several “sham” items designed to gauge accuracy of reporting over time. Surveys were completed every 6-months for 24-months (two years) which is a sufficient time frame to assess the effect of the interventions.

Most importantly, schools were blinded to which group they were placed in and teachers and students not involved in the study were not aware of the trial occurring at the school. The students involved were unaware of the real purpose and scope of the study. These factors are important to consider because it held eliminate secondary effects and helps support the direct efficacy of the interventions themselves.

The results were impressive: reduced frequency and quantity of drinking occurred in the high-risk students that received the intervention compared to the control students that did not. While HR students were overall more likely to report drinking than low-risk (LR) students, the HR students saw a significant effect of the personality-targeted interventions on drinking behavior.

Conrod et al.2013 abstract

A study of this size is incredibly complex and the statistics involved are equally complex. The author’s analyzed the data in a number of ways and published the results in several papers. A recent study modeled the data over time (the 24-months in which the surveys were collected) and used these models to predict the odds that the students would engage in risky drinking behavior. The authors reported a 29% reduction in odds of frequency of drinking by HR students receiving the interventions and a 43% reduction in odds of binge drinking  when compared to HR students not receiving the interventions.

Interestingly, the authors report a mild herd-effect in the LR students. Meaning that they believe the intervention slowed the onset of drinking in the LR students possibly due to the interactions between the HR student’s receiving the interventions and LR students. However, additional studies will need to be done in order to confirm this result.

Recall that the Reckless Behavior Questionnaire (RBQ) was utilized in this study to quantify drug-taking behavior. While the study was specifically designed to measure effects on alcohol, the RBQ also included questions about marijuana. So the authors reanalyzed their data and specifically looked at effects of the interventions on marijuana use.

Mahu et al. 2015

The found that the sensation seeking personality sub-type of HR students that received an intervention had a 75% reduction in marijuana use compared to the sensation seeking HR students that did not receive the intervention. However, unlike the findings found on alcohol use, the study was not able to detect any effect on marijuana use for the HR students in general. Nevertheless, the data suggest that the teacher/counselor administered interventions are effective at reduce marijuana use as well.

While you may be unconvinced by the modest reduction in drinking and marijuana frequency reported in these studies and may be skeptical of the long-term effect on drug use in these kids, keep in mind that the teachers and counselors that administered these interventions received only 2 or 3 days of training and the interventions themselves were very brief, only two 90-minute sessions. What I find remarkable is that such a brief, targeted program can have ANY effects at all. And most importantly, the effects well outlasted the course of the interventions for the full two-years of the follow-up interviews.

These targeted interventions have four main advantages:

  1. Administered in a real-world setting by teachers and counselors
  2. Brief (only two 90-minute group sessions)
  3. Cheap (the cost of training and materials for the group sessions)
  4. Effective!

The scope of this intervention needs to be tested on a much larger cohort of students in a larger variety of neighborhoods but it is extremely promising nonetheless. Also, it would be interesting to breakdown these data by race, socioeconomic status, and gender, all of which may impact the effectiveness of the treatments and was not considered in this analysis. Finally, how would you implement these interventions on a wide scale? I eagerly look forward to additional work on these topics.

Thanks for reading 🙂

See these other articles in Time and on King’s College for less detailed discussions of these studies.

Also see these related studies from Conrod’s group:

Castellanos-Ryan N, Conrod PJ, Vester JBK, Strain E,, Galanter M, Conrod PJ. Personality and substance misuse: evidence for a four-factor model of vulnerability. In: Vester JBK, Strain E, Galanter M, Conrod PJ, eds. Drug Abuse and Addiction in Medical Illness. Vols 1 and 2. New York, NY: Humana/Spring Press; 2012.

Conrod PJ, Pihl RO, Stewart SH, Dongier M. Validation of a system of classifying female substance abusers on the basis of personality and motivational risk factors for substance abuse. Psychol Addict Behav. 2000;14(3):243-256.

Conrod PJ, Stewart SH, Comeau N, Maclean AM. Efficacy of cognitive behavioral interventions targeting personality risk factors for youth alcohol misuse. J Clin Child Adolesc Psychol. 2006;35(4):550-563.

Conrod PJ, Castellanos-Ryan N, Strang J. Brief, personality-targeted coping skills interventions and survival as a non-drug user over a 2-year period during adolescence. Arch Gen Psychiatry. 2010;67(1):85-93.

O’Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J AmAcad Child Adol Psychiatry. 2010;49(9):954-963.

Promising Shifts in Policy Towards Addiction Prevention and Treament

Spilled prescription medication --- Image by © Mark Weiss/Corbis
Spilled prescription medication — Image by © Mark Weiss/Corbis

 

Normally a search for drug addiction in Google news pulls up a similar thread of articles: arrests of dealers and addicts, big drug busts, a crime committed by a user or dealer, somebodies mug shot. Basically, the news tends to cover only the drug enforcement and criminal aspects of the drug addiction problem. This is unsurprising since for the past few decades the lens in which we view addicts and addiction has been smeared by the “War on Drugs”, which views drug users as criminals and deviants and seeks to punish rather than treat. However, with advances in medical technology, advances in neuroscience, cognitive psychology, and a host of related fields, we understand addiction at the neurochemical and physiological level better than we ever have before. A shift in attitude that acknowledges addiction as a medical disease that needs to be treated as such (well established in the scientific community) is finally making its way into public consciousness, and most importantly, public policy.

SFN 2015 LogoI was recently at the 2015 Society for Neuroscience Conference, an enormous gathering of neuroscientist from around the world, held Oct 17-21 in Chicago. The conference hosts an overwhelming number of lectures, symposia, and workshops for scientists to share the latest developments in research in Alzheimer’s, Parkinson’s, stroke, learning and memory, brain development, addiction, and many others neuroscience sub-disciplines. Several special lectures on neuroscience related-topics are also held and I had the pleasure of attending one of these special lectures given by the Honorable Jed S. Rakoff, Senior US District Judge for the Southern District of New York and founding member of the MacArthur Foundation Project on Law and Neuroscience, which researches issues on the intersection of law and neuroscience. Judge Rakoff spoke on how new advances in neuroscience research such as improved neuroimaging technologies and greater understanding into human cognition and decision-making, is changing how the law treats defendants. Significantly, Judge Rakoff spoke frequently about addiction, and he acknowledges what many do, that those arrested for non-violent offenses should be treated, not brutalized. However, he explained that many judge’s hands are tied when it comes to sentencing due to laws in place that set mandatory minimums for drug offenders. Judge Rakoff believes these mandatory minimum laws should be eliminated if progress is to be made toward providing treatment, rather than prison sentences, for drug addicts. It was refreshing to hear this come from such a distinguished judge and I hope it is a bellwether for changes in our legal system.

Of course, laws cannot changes without lawmakers to change them. But we may be seeing the beginning of shift in drug addiction policy for the first time in years.

The epidemic of addiction to prescription opioids and heroin has been making news for months now. I’ve blogged about this epidemic in several posts. One covering a review article describing the epidemic, another sharing an excellent article in the Huffington Post about the epidemic and available treatments for opioid addiction, and most recently, an important report released by the Centers for Disease Control that names opioid addiction as one of the counties top public health crises. Following this latter groundbreaking report by the CDC, policy-makers are finally starting to wake up to the problem.

In a speech in on October 21 in Charleston, West Virginia, one of the areas in the country worst hit by the opioid problem, President Obama held an hour-long public forum in which he promised $133 million dollars to combating the prescription opioid and heroin problem. The President gave about a 15-minute introduction to the event, which entailed some of the most refreshing comments about addiction to ever come from a US President.

Watch the full speech here:

President Obama began by citing shocking statistics stated in the CDC report concerning the surge in deaths due to prescription opioids, “More Americans now die from drug overdoses than from motor vehicle crashes…The majority involve legal prescription drugs.” He went on to talk about heroin as an extension of prescription opioid abuse, “4 out of 5 heroin users start with prescription opioids”.

Of special significance was the shift in language he used to describe addiction and addicts, which contrasts strongly with the “War on Drugs” rhetoric of the previous administration. Obama said, “This is an illness and we have to treat is as such. We have to change our mindset”, which is something that scientists have been arguing for years but is just now being acknowledged by a US President.

Progress towards treating addiction cannot be made unless the biological and medical realities of the illness are understood and addicts are treated as patients rather than criminals. Indeed, stigma towards addicts is one of the biggest hurdles towards reforming public health policy and attitudes towards addiction and President Obama admitted this, “We can’t fight this epidemic without eliminating stigma.”

Some progress has been made under Obama’s watch and he and Health and Human Services Secretary Sylvia Burwell outlined several addiction reforms. One important change already in place is a stipulation of the Affordable Care Act that requires insurance to cover treatment for substance abuse disorders. Secretary Burwell outlined three points at the forum in West Virgina for an “evidence-based strategy” towards addiction prevention and treatment:

  • Point 1: Changing prescribing practices. This is necessary to stem the over prescription of opioids and the dependence to the drugs that develops in some patients as result.
  • Point 2: Expand medication-assisted treatment programs and to make sure patients can have access to treatment and behavioral counseling that can help them.
  • Point 3: Increased access to naloxone. Naloxone counteracts the effects of opioids and should be a standard medication on hand for any first responder that deals with overdoses.

The details about implementing these strategies were not provided though.

However, Obama’s speech may be coming too late, as Dr. Andrew Kolodny, founder of the Phoenix House Treatment facilities in New York, believes. As reported in New York Times, Dr. Kolodyn is disappointed with Obama’s progress and thinks he has waited too long to take action and says that opioid epidemic problem has gotten considerably worse over under Obama’s watch.

I am anxious to see what changes may occur within the last year of Obama’s presidency in respect to the opioid epidemic. However, if more permanent changes are not made in the law, a conservative Republican president could easily over turn any changes made and revert to a failed Reagan-era “War on Drugs” approach.