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). Read More

Emergent Medical Data

By Mason Marks

In this brief essay, I describe a new type of medical information that is not protected by existing privacy laws. I call it Emergent Medical Data (EMD) because at first glance, it has no relationship to your health. Companies can derive EMD from your seemingly benign Facebook posts, a list of videos you watched on YouTube, a credit card purchase, or the contents of your e-mail. A person reading the raw data would be unaware that it conveys any health information. Machine learning algorithms must first massage the data before its health-related properties emerge.

Unlike medical information obtained by healthcare providers, which is protected by the Health Information Portability and Accountability Act (HIPAA), EMD receives little to no legal protection. A common rationale for maintaining health data privacy is that it promotes full transparency between patients and physicians. HIPAA assures patients that the sensitive conversations they have with their doctors will remain confidential. The penalties for breaching confidentiality can be steep. In 2016, the Department of Health and Human Services recorded over $20 million in fines resulting from HIPAA violations. When companies mine for EMD, they are not bound by HIPAA or subject to these penalties.

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Introducing New Blogger Mason Marks 

Mason Marks is joining Bill of Health as a regular contributor.

Mason is a Visiting Fellow at Yale Law School’s Information Society Project. His research focuses on the application of artificial intelligence to clinical decision making in healthcare. He is particularly interested in the regulation of machine learning and obstacles to its adoption by the medical community. His secondary interests include data privacy and the regulation of emerging technologies such as 3D-bioprinting, surgical robotics, and genome editing.

Mason received his J.D. from Vanderbilt Law School. He is a member of the California Bar and practices intellectual property law in the San Francisco Bay Area. He has represented clients in the biotechnology, pharmaceutical, and medical device industries. Prior to law school, he received his M.D. from Tufts University and his B.A. in biology from Amherst College.

Representative Publications:  Read More