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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Factory farming, human health, and the new WHO Director General

By Nir Eyal

Last week, over 200 experts called on the next Director General of the World Health Organization to prioritize factory farming in an open letter. Announced in articles in the New York Times and The Lancet, the letter argues that factory farming is a major barrier to better global health. The letter does not make this argument on animal rights grounds – although this argument is certainly strong – but instead focuses on factory farming’s contribution to antibiotic resistance, climate change, and the rise of chronic diseases. These three issues formed the core of the last Director General’s agenda, although limited attention was paid to factory farming, which the authors argue, “connects the dots among them.”

One of the authors is Scott Weathers, a Global Health and Population MSc student at the Harvard T.H. Chan SPH. The other is Sophie Hermans, a doctoral student from Cambridge U. Their letter received overwhelming response. On twitter, their announcement of the letter was the #1 trending tweet on all relevant hashtags for the recent World Health Assembly.

Congratulations, Scott and Sophie!

(I am among the letter signatories.)

Jelly Beans, Booze, and B-Vitamins

By Seán Finan

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy product. Candy companies that tried to add vitamins their products to market them as “healthier” have already been targeted by the FDA. But take a quick glance at the shelves of any convenience store: the “healthy”, vitamin enriched snacks and drinks are so full of sugars, flavors and sweeteners that it would take a doctorate in metaphysics, rather than medicine, to distinguish them from the candy and soda. So, maybe the FDA’s stance on adding a spoonful of sugar to help the medicine go down has relaxed. With that in mind, here’s a little thought experiment. I’d like to bring a proposal back from the eighties: that inexpensive alcoholic beverages be fortified with allithiamine, a fat-soluble analogue of Vitamin B1.[1] Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.

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Playing the Long Game: Epigenetics and Public Health

By Seán Finan

Good investing takes time, foresight and patience. You have to thoughtfully spend now for a big return in ten years. But when it comes to investments in public health, everybody wants to make a quick and easy buck. I’ve written before about the need for more emphasis on preventive care over “heroic medicine”: it costs less, it’s easier to administer and it leads to better outcomes. But fully realizing the potential of preventive care and public health initiatives takes more than vaccines and check-ups. The government could invest in an unlimited buffet of hospital examinations and laboratory tests for all, but if people can only afford food that leaves them obese and diabetic or if they live in neighborhoods where crack dens and meth labs outnumber the schools, the investment is not going to pay off. Addressing the social determinants of health has incredible potential to improve outcomes on a population level.

Efforts are already being made. The government aims for “Health in All Policies” by promoting holistic education programs for poor youths and funding better food in stores in neglected communities. Other initiatives focus on fighting food insecurity among families or homelessness among pre and post natal mothers. The topic was covered well in this article from the Kaiser Family Foundation. They break the social determinants of health into the broad categories of social, economic and environmental factors. Things like economic stability, neighborhood and physical environment, education, food and social context play a massively underappreciated role in health outcomes. The article contains a graphic on the impact of different factors on the risk of premature death. Apparently, healthcare has the smallest impact at 10%. Individual behaviors carry the biggest single impact at 40%. The social and environmental factors that the article focuses on contribute 20%. The last factor was genetics, at 30%. As I was reading, I remembered seeing this article on epigenetics and it struck me that the separation of genetics from behavior and environmental factors might be a little artificial.

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Making a Moral Case for Regulation

Valerie Braithwaite’s chapter in the ANU’s Press’s new Regulatory Theory: Foundations and Applications provides a general introduction to looking at regulation through a social lens.  If regulation is so great, she asks, why do so many people approach it with fear and loathing?

I won’t rehearse her argument here, but instead skip to some key points about how we who appreciate the social good provided by regulation can best make that case. One of ten suggestions she concludes with was particularly resonant to me: “Engage with dissent on moral grounds. Is it right morally to steer the flow of events in the way proposed?”

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2/22: Michael Sandel & author Yuval Harari discuss new book Homo Deus

Register for this event

Harvard Book Store and welcomes the bestselling author of Sapiens Yuval Noah Harari for a discussion of his latest book, Homo Deus: A Brief History of Tomorrow. Harari will be joined in conversation by Harvard’s Michael Sandel, author of Justice: What’s the Right Thing to Do? and What Money Can’t Buy: The Moral Limits of Markets.

This event is open to the public, but tickets are required. Tickets are available online only via the Harvard Book Store. Ticket price of $34.75 includes a copy of the book. Purchase tickets now! Read More

Chimeras with benefits? Transplants from bioengineered human/pig donors

By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Read More

Losing the Arms Race: Health Policy and Anti-Microbial Resistance

By Seán Finan

And scattered about it, some in their overturned war-machines, some in the now rigid handling-machines, and a dozen of them stark and silent and laid in a row, were the Martians–dead!–slain by the putrefactive and disease bacteria against which their systems were unprepared; slain as the red weed was being slain; slain, after all man’s devices had failed…

H.G. WellsThe War of the Worlds  

The WHO World Antibiotic Awareness Week ran from 15-22 November. It coincided with similar European and American initiatives. So, in the interests of raising awareness, I thought I would highlight a few figures.

Photo by Rocky Mountain Laboratories, NIAID, NIHAntimicrobial resistance currently causes an estimated 70,000 deaths annually. If current practices continue, the death toll is expected to hit to ten million per year by 2050. That works out at about one death every three seconds.

The threat isn’t limited to increased mortality. Anti-microbial resistance could cast medical practice back to turn-of-the-century standards. Turn of the 20th century, that is. Without antibiotics, the chance of infection turns chemotherapy and invasive surgeries into mortal gambles. During these procedures, the body’s immune system is subject to massive exposure and needs antibiotic support. Even ordinary nicks and scratches can lead to fatal infections without effective antibiotics.

So what is antimicrobial resistance? How does it come about? What can we do to combat it and prevent the “antibiotic apocalypse”?

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Organs and Overdoses (Part II): ‘Higher risk’ donors

By Brad Segal

In my last post I characterized how overdoses from the surging opioid epidemic have become the fastest-growing cause of mortality among organ donors. In this update, I raise one potential consequence with ethical and policy implications: so-called donor-derived infections. To be clear, I focus primarily on organ recipients as deaths from drug overdose, and drug addiction more broadly, should be prevented regardless of any implications for transplantation. With this in mind, consider how the population of injection drug users shoulders a heavy burden of HIV, hepatitis B (HBV) and hepatitis C (HCV) (Table 1). First I will focus on screening guidelines, and then will move on to transplantation of organs known to carry an infection. table-1

Screening guidelines can help reduce the incidence of donor-derived infections, but the lab tests recommended in any policy must balance two potential concerns. First, lab tests have a rate of false negative results. Transplants of these organs will accidentally increase donor-derived infections. The policy question, then, is whether or not transplanting organs donated by individuals with higher risk of recent disease exposure will expose an unacceptable proportion of recipients to infection. This unintentional harm could undermine a duty of non-maleficence to organ recipients. Further complicating a potential screening policy is that the basic lab tests for HIV, HBV, and HCV detect the presence of human antibodies, which work well among a low-risk population, but antibodies might not appear in the blood until weeks after infection (Table 2).Recent infections are better detected by nucleic acid amplification (NAT) testing.To mitigate risk of infection,then, transplant screening policies should require a heightened level of surveillance among donors with a history of illicit drug use. Read More

Loneliness as epidemic

By Wendy S. Salkin

Just a few weeks ago, The New York Times ran an article confirming that, indeed, we are facing an epidemic of loneliness. There is “mounting evidence” that links loneliness to illness, as well as “functional and cognitive decline.” What’s more, loneliness turns out to be a better predictor of early death than obesity.

Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)

The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:

  1. Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
  2. The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.

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