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. Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.
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.
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?”
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! Continue reading
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. Continue reading
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. Wells, The 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.
Antimicrobial 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”?
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.
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. Continue reading
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:
- 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.”
- 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.
By Brad Segal
The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.
To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).
One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Continue reading
By Brad Segal
I just watched the movie Concussion (2015) as an assignment for one of my bioethics courses. The movie is about a physician, Dr. Bennet Omalu, as he unravels the association between playing in NFL and an acquired neurodegenerative disease, a condition he calls, “chronic traumatic encephalopathy” (CTE). At one point Dr. Omalu tries to convince a prominent researcher that, despite suffering head traumas similar to those of football players, animals like the woodpecker have the means of avoiding CTE;
“The woodpecker’s tongue comes out the back of the mouth through the nostril and goes around the top of its head. Basically, it’s one big safety belt for the brain.” (source)
The tongue shoots out through the nostril? As a medical student, I found this trivial aside absolutely fascinating. But when I tried to learn more I quickly realized–to my dismay–that most experts would balk at this characterization. Woodpeckers don’t develop CTE for a variety of reasons, including; (1) smaller mass means less force from deceleration; (2) no head rotation during each peck as to decrease angular forces, and; (3) their skulls have a physiologic protective cushion. I won’t delve further into the weeds about where exactly the movie’s assertions depart from reality, but to put it generously, this crucial argument totally misrepresents the science.
The problem with all of this is that it’s tempting to watch Concussion and feel better informed about the controversies surrounding professional football and CTE. To be honest, I was mesmerized watching familiar events brought to life on screen, and it all seemed credible as it used the actual names of people involved. Movie reviews by Rolling Stone even suggest that it should be mandatory for football fans, and The New York Times remarks on how it, “sells a complex issue.” Sure, everyone knows Concussion is “for entertainment purposes only,” but can’t stories that are true also be entertaining? However, the seemingly-trivial inaccuracy about woodpeckers was a potent reminder that this film is not a documentary. Concussion should be viewed as it is–a major Hollywood blockbuster starring Will Smith and Alec Baldwin.
Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.
First, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading
by Zachary Shapiro
Psychological research on “affective forecasting,” studying individuals’ ability to predict their future emotional states, consistently shows that people are terrible at predicting their ability to adapt to future adversity. This finding has particular significance for medical decision-making, as so many serious health decisions hinge on quality-of-life judgments, generally made by an individual balancing risks and benefits they perceive of a future state that is likely to result from a given therapeutic regime.
Much of the research on affective forecasting has focused on high-stakes events, restricting study participation to those likely to find the study event particularly significant, such as tenure-track faculty, registered voters, or sports enthusiasts. Despite a growing body of research on forecasting biases in the medical domain, little work has previously systematically considered such biases in clinical genetics. However, as the prevalence of genetic testing has increased, scholars have noticed forecasting deficiencies with increasing regularity.
While evidence suggests that those who receive genetic testing, whether they are non-carriers or carriers of specific genes, differ in terms of short-term general psychological distress, their long-term distress levels do not differ significantly. Results of research into the affective reactions of patients undergoing predictive genetic testing suggest that, in general, psychological outcomes are not as negative as one may expect.
I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.
On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.
Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.
Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].
Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.
The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.
Here is what FDA said with my analysis in bold:
In April, a kidney donation from an unrelated living donor was put on hold in South Portland, Maine. The reason was unusual: the generosity of the community. In response to an online fundraising for the donor, 768 people contributed over $49,000—well beyond what can reasonably be called “compensation.” The hospital thus had to ask the question: Is the donation procedure in conflict with the law now that the donor stands to profit from it? After initial media coverage, there was no further news about this case. On Monday, however, it was announced on the fundraising page that the transplant is back on track and due to happen in two weeks. Does that mean that we now have a loophole in the ban against commercialization of organs?
The case is unprecedented. There are and have been other online fundraisers to compensate donors. But this is the first time that the unpredictable powers of the internet kicked in (remember the guy who raised $55,000 to make a potato salad?). The law prohibits any monetary payments to organ donors. The situation poses two questions: What should be done in this particular case, and how should fundraising for organ donors be regulated going forward?
It appears that the first question was somehow resolved even though we don’t know how: Did the hospital decide it was not a problem after all, or did the donor agree with the hospital’s reported initial suggestion of donating the “excess” money to some other organization? In either case, what follows remains problematic.
How bad is the obesity epidemic among kids in America?
Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.
And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”
The freedom to develop cardiovascular disease?
School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]
Read the full article here.
By Kelsey Berry
This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:
The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.
The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.
by Vadim Shteyler
Efforts to improve health care quality under the ACA have been directed towards expanding EHR use and health IT, improving care delivery by promoting care coordination and population health, and laying incentives for providers to meet quality measures. The 33 ACO quality measures include 8 measures to evaluate preventive care, 12 measures to address goals of managing 4 common diseases, and 7 to assess patient satisfaction. Though quality improvements have not been consistently shown, studies have found modest Medicare spending reductions. In fiscal year 2013, CMS began reducing health care reimbursement rates to hospitals with excessive 30-day readmission rates, as generalized by their readmission rates for heart attacks, heart failure, and pneumonias. These were extended to include readmission rates for hip and knee surgeries in fiscal year 2015. And, as readmissions were estimated to account for $17.5 billion of Medicare costs in 2012 (in part attributable to insufficient discharge services, access to outpatient care, and follow-up), efforts to curb them are expected to continue.
The ACO quality measures have been criticized for being too process oriented (as opposed to outcomes oriented). And, undoubtedly, so few quality measures can’t encapsulate all of health care. Noted shortcomings of readmission rates as a valid indicator of quality include that they do not differentiate between planned and unplanned readmissions and they don’t adequately control for different case-mixes between hospitals. As psychiatric illness is often poorly recorded in medical records, it is a major confounder that may impact different hospitals differently. In this blog post, I add the speculative concerns of a medical student from limited experiences on the wards. Continue reading
From Harvard Catalyst:
March 23: Symposium
9:00 AM – 5:00 PM
Joseph B. Martin Conference Center
Harvard Medical School
Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.
Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading
by Vadim Shteyler
As a medical student on the wards, physicians often recounted stories of horrifying acts of paternalism from the days of their training. Though paternalism is far from abolished, the progress we have made as a profession has become a source of some pride. On the wards, autonomy has become exalted as a sacred right and invoking paternalism can end most debates. Though autonomy is a complicated and frequently debated concept, most agree that the cultural shift is a step in the right direction. And though perhaps we should be proud of our steps towards protecting the way patients receive information in clinic, we should be more aware of other sources of patient information as well.
Of course, it may not come as a surprise that a lot of the medical information available to patients is less than accurate. With the Internet, ubiquitous misinformation about anything should be expected. However, when we think about the sources of that misinformation we often think about random websites found during quick Google searches, Wikipedia, sensationalized media coverage, and pharmaceutical advertisements (the later will be discussed further below). A few recent studies are bringing attention to more surprising culprits: Hospitals and Academic Institutions. Continue reading