Buprenorphine and Naloxone Legislative Restrictions: A Compromise Towards Harm Reduction

Limiting access to MAT can result in patient harm. Improving access using a bridge therapy model may help save lives.

There were approximately 64,000 deaths from opioid overdose in 2016, including deaths from both prescription and illicit drugs. The incidence of opioid overdose has continued to escalate despite a number of efforts. Increasing treatment beds, limiting opioid prescriptions, distribution of naloxone and other efforts have not demonstrated a significant impact on non-medical opioid use or on opioid-related deaths.

The continuing rise in opioid overdose and overdose death has resulted in the declaration by the current executive administration of the opioid epidemic as a “Public Health Emergency”.

Medication assisted treatment (MAT) with agents such as methadone or buprenorphine/naloxone has been demonstrated to be one of the more effective measures in the reduction in high-risk opioid use among individuals with substance abuse disorder. Specifically, treatment with buprenorphine/naloxone has demonstrated efficacy in harm reduction with the advantage of a reduced potential for abuse, a safer therapeutic profile than alternatives, and it can be safely prescribed in the outpatient setting. Use of this therapeutic however, is currently restricted to only certain licensed providers in certain clinical settings, limiting access to this important life-saving intervention.

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The Need for Institutional, Individual and Community Based Responses to the Opioid Crisis

By John Alexander Short

Panelists discussed responses to the opioid crisis during a recent webinar.

Dr. Monica Bharel, the Commissioner of the Massachusetts Department of Health, recently hosted a webinar panel to discuss the many consequences of the modern opioid epidemic on families.

Hosted jointly by the Association of State and Territorial Health Officials (ASTHO) and The Forum at the Harvard T.H. Chan School of Public Health, the event also included Dr. Stephen Patrick, Dr. Karen Remley, and Dr. Michael Warren who joined Bharel for a talk titled “State Health Leadership: Understanding & Responding to the Lifelong Effects of Opioid Exposure for Infants, Children & Families.”

The discussion offered insight into the complex nature of addiction and the need to understand the disease to craft effective solutions.

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What is in America’s Medicine Cabinet? Everything.

By Stephen P. Wood

pills

Prescriptions should never be the first option for healtcare providers. (mpcaphotos/Flickr)

There were 240 million opioid prescriptions in the U.S. in 2016, a number that accounts for about 30 percent of the world’s opioid prescriptions, and is enough for one opioid prescription for every adult American.

Experts believe the overprescribing of opioids is at least somewhat responsible for the current opioid crisis. This led to a national discussion around prescribing stewardship, as well as the development of policy and regulation with regard to opioid prescribing. Included among this have been limits on the duration of therapy, partial fills, and requirements that providers access their state’s prescription monitoring program before prescribing. These policies have had some success and there has been a decline in the number of opioid prescriptions in the last several years.

This should be good news, but unfortunately, opioids aren’t the only thing filling America’s medicine cabinets. Looking again at 2016, there were more than 190,000 kilos of amphetamines, drugs like Adderall and Ritalin, produced for consumption in the United States. The estimates are that about 16 million adults and more than 3.5 million children are taking these stimulants.

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NIMBYism continues to factor into supervised injection site policies

supervised injection site

Insite, in Vancouver, Canada, is a supervised injection facility. (Screengrab via HCLU/Vimeo)

By Daniel Goldberg

As a major tool in harm reduction policy connected to opioid and substance misuse, more than 30 states have implemented syringe exchange programs, or SEPs.

Surmounting or, in many cases, bypassing the considerable legal and political obstacles has proved a challenge for states, whether they succeeded in enacting SEPs or not. While, given the opioid crisis, SEPs are more important than ever, they do have limitations.

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Prescription Monitoring Programs: HIPAA, Cybersecurity and Privacy

By Stephen P. Wood

Privacy, especially as it relates to healthcare and protecting sensitive medical information, is an important issue. The Health Insurance Portability and Accountability Act, better know as HIPAA, is a legislative action that helps to safeguard personal medical information. This protection is afforded to individuals by the Privacy Rule, which dictates who can access an individual’s medical records, and the Security Rule, which ensures that electronic medical records are protected.

Access to someone’s healthcare records by a medical provider typically requires a direct health care-related relationship with the patient in question. For example, if you have a regular doctor, that doctor can access your medical records. Similarly, if you call your doctor’s office off-hours, the covering doctor, whom may have no prior relationship with you, may similarly access these records. The same holds true if you go to the emergency department or see a specialist. No provider should be accessing protected information however, without a medical need.

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What is the Role of the Judiciary in Tackling the Opioid Epidemic?

By Ryan J. Duplechin

The Judicial Panel on Multidistrict Litigation has centralized suits in the Northern District of Ohio.

As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.

In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.

“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”

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Hepatitis C Virus Infection: Another Consequence of the Opioid Epidemic

By Stephen P. Wood

And increase in diagnosis of the hepatitis C virus increase goes hand in hand with the opioid epidemic. (Zerbor/Thinkstock)

The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration.

There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact of the epidemic, but this is only the tip of the iceberg. Hepatitis C is another epidemic that goes increasingly hand-in-hand with the opioid crisis, and is likely to take a long-term toll on American lives as well. Intravenous drug use accounts for approximately 80 percent of new cases of hepatitis C virus (HCV) infection in the United States, and without intervention these numbers could continue to climb. Continue reading

As opioid overdose numbers rise, so does the cost of naloxone 

naloxone overdose reversal kit

Photo via bcgovphotos/Flickr

By Stephen P. Wood

Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.

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Taking a Humanitarian Approach to the Opioid Epidemic

By Stephen P. Wood 

The opioid epidemic has been declared a public health emergency, allowing for access to public health funding, in an effort to raise awareness and deploy public health initiatives. This declaration was in response to the growing numbers of overdoses and overdose deaths in the United States.

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Insurers are making it harder for me to treat my opioid-addicted patients

By Brian Barnett, via the Washington Post

Brian Barnett is an addiction psychiatry fellow at Massachusetts General Hospital/McLean Hospital and Harvard Medical School. On February 28, 2018, he was participated in the panel discussion Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred” at Harvard Law School. 

I’m an addiction specialist, and my voice-mail inbox is always nearly full. Some messages are from desperate individuals looking for outpatient treatment or help finding a detoxification program. Others are from patients needing a letter confirming their treatment for a child-custody dispute or care providers informing me that my patients have been hospitalized.

It’s hard to know what to expect, but invariably one type of message awaits: voice mails from pharmacies informing me that a patient’s insurance provider will not approve payment for the medication to treat their opioid addiction unless I obtain prior authorization from the insurer.  Continue reading

Facebook Should ‘First Do No Harm’ When Collecting Health Data

By Mason Marks

Following the Cambridge Analytica scandal, it was reported that Facebook planned to partner with medical organizations to obtain health records on thousands of users. The plans were put on hold when news of the scandal broke. But Facebook doesn’t need medical records to derive health data from its users. It can use artificial intelligence tools, such as machine learning, to infer sensitive medical information from its users’ behavior. I call this process mining for emergent medical data (EMD), and companies use it to sort consumers into health-related categories and serve them targeted advertisements. I will explain how mining for EMD is analogous to the process of medical diagnosis performed by physicians, and companies that engage in this activity may be practicing medicine without a license.

Last week, Facebook CEO Mark Zuckerberg testified before Congress about his company’s data collection practices. Many lawmakers that questioned him understood that Facebook collects consumer data and uses it to drive targeted ads. However, few Members of Congress seemed to understand that the value of data often lies not in the information itself, but in the inferences that can be drawn from it. There are numerous examples that illustrate how health information is inferred from the behavior of social media users: Last year Facebook announced its reliance on artificial intelligence to predict which users are at high risk for suicide; a leaked document revealed that Facebook identified teens feeling “anxious” and “hopeless;” and data scientists used Facebook messages and “likes” to predict whether users had substance use disorders. In 2016, researchers analyzed Instagram posts to predict whether users were depressed. In each of these examples, user data was analyzed to sort people into health-related categories.

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TOMORROW! Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred

Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred
February 28, 2018 5:15 PM – 7:15 PM
Wasserstein Hall, Room 1023
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Is addiction a disease? And does it matter for the criminal law? The Massachusetts Supreme Judicial Court now faces these questions in the potentially landmark case, Commonwealth vs. Julie Eldred. The Court must decide if it is constitutional for the criminal justice system to require addicted offenders to remain drug free. Is this requirement like asking a patient in cancer remission not to get cancer again? Or is it simply requiring someone to make better decisions? As the country faces an opioid epidemic, the case has drawn national attention.

Join us at Harvard Law School for a conversation with key legal and scientific experts involved in the case. Confirmed participants include: defense attorney Lisa Newman-Polk, and psychologist Dr. Gene Heyman, scientific expert in support of the Commonwealth.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Learn more about the event here!

NEW EVENT! Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred

Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred
February 28, 2018 5:15 PM – 7:15 PM
Wasserstein Hall, Room 1023
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Is addiction a disease? And does it matter for the criminal law? The Massachusetts Supreme Judicial Court now faces these questions in the potentially landmark case, Commonwealth vs. Julie Eldred. The Court must decide if it is constitutional for the criminal justice system to require addicted offenders to remain drug free. Is this requirement like asking a patient in cancer remission not to get cancer again? Or is it simply requiring someone to make better decisions? As the country faces an opioid epidemic, the case has drawn national attention.

Join us at Harvard Law School for a conversation with key legal and scientific experts involved in the case. Confirmed participants include: defense attorney Lisa Newman-Polk, and psychologist Dr. Gene Heyman, scientific expert in support of the Commonwealth.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Learn more about the event here!

The Opioid Crisis Requires Evidence-Based Solutions, Part III: How the President’s Commission on Combating Drug Addiction Dismissed Harm Reduction Strategies

By Mason Marks

Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated 91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).

In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Continue reading

The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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