Accidental poetry of our bioethics discussions

Yeah, but think about all the unnamed street junkies

that have died 

under bridges

never found.

 

Yeah, all of these questions

–these questions on access to healthcare

and treatment–

are certainly paramount.

But just from the abstract theoretical level

I would say

there isn’t a meaningful difference

between

somebody who’s well off

and

someone who is snorting coke fourteen times a day.


Medical device history right before our eyes

A constant refrain in my classes is the fact that much of the history we are living through goes unwritten. That though it is important and significant and causal and the thing to which we will one day refer, the actual happenings of history often go unremarked upon. And I think there’s something to be said about that.

Anyway, such an event is set to occur. Titled. Rethinking the Way FDA Regulates Digital Health Devices: FDA’s Software Precertification Program, a session hosted by the U.S. Food and Drug Administration (the “FDA”) at the annual MedTech Conference will be the place where much of the dialogue about what a modern day regulatory environment should/will/might be to achieve any number of interests represented or spoken to in that room. “In the room where it happens” in today’s parlance.

“The interactive session will discuss how the FDA is looking at new and more efficient ways to regulate software-based medical technologies,” we are told in an invitation to join the session. Fundamental aspects of the agency’s interpretation of the Digital Health Innovation Action Plan and its implementation of the 21st Century Cures Act – you know, important, significant, and causal aspects of medical legislation that need to be done in this country to modernize our healthcare system as it makes increasing use of small-unit, wide-scale, computationally efficiency, electronically based systems that are coming to describe who and what we are with ever greater precision, accuracy, detail, and tedium? you know, that thing your president does not care the least whit about and for which we have seen a precarious rise in “big tech” partnerships that either signal a bright new horizon in regulatory affairs or something suggesting similar partnerships as seen in “big pharma’s” hey-day, you know that thing that will decide how a lot of this stuff ends up happening? – will all be discussed.

And just in case you think I’m spouting on about nothing at all, keep in mind that both Tony Blair and George W. Bush will attend and speak at this same conference. Just in case the Prime Minister of the United Kingdom from 1997 to 2007 and the 43rd President of the United States were just somehow flukes at an otherwise no-name conference, also in attendance?: Chairman and CEO of Johnson & Johnson, another Chairmen for another medical products and services company serving the healthcare industry, a Partner at a high-profile law firm, a Chairwoman of a medical device company which was recently granted FDA Marketing Clearance, and the Directory of the Center for Devices and Radiological Health at that very same U.S. Food and Drug Administration. With over a dozen of the world’s multibillion dollar biomedical corporations sponsoring the event, I imagine a few of the people in a few of those rooms are going to be exchanging words of profound later significance. Could we but crane our necks back enough to take it all in, we might be able to pinpoint the sentence upon which the future hangs. 

And it’s about to happen.

Should you wish to attend, are in the area, have some coin to spend on such things (a Standard Non-Manufacturer for Non-Members costing $2,495, you “Academic/Non-Profit/Government” types can get away with $1,495, and perhaps knowing a good whale when they see them, the organizers have decided to let Venture Capitalists, Private Equity, and Angel Investors in at the bargain, low-down price of $1,395), you can do so at the link found here.

Much will be decided. How much will be written?


The Unaffiliated

One can’t help but see the significant change in the religiously unaffiliated (36.6 million to 55.8 million, 52% increase) as something significant we are going through as a nation. The implications extend in particular to our domain around the edges of end-of-life care and beginning-of-life delineations. There’s a few things in between (generally sex and gender related, go figure), a few oblique (interesting thoughts on cannibalism and the power of true resolve) and a generally striving towards truth, consequences, and the American way, but this changing (and somewhat predictably) changing landscape of religion cannot help but influence large swaths of medical care, medical legislation, and – ultimately – religious medical practices. I post the figure below from the Pew Research Center only to note a truth of the world and ask no one in particular how the medical profession is responding to this cultural shift (and impending waves coming to two key life cycles with distinct realms of medical care (e.g., OB/GYN, geriatrics, etc.) to best address the needs of patients. 

Changing U.S. Religious Landscape


I insert as post script here, after a few days thinking the following. And you get to wondering, how many fear that next horizon? The day when the religiously apathetic are the dominant religious group in America. It’s never happened before. It’s about to happen as the scales are liable to keep tilting as they are. Having seen much of the response to this point, I wonder what will happen around 2020, when some scales tilt for good.


Science popularization these days

I miss the upliftingness of science. The soaring eloquence, the phrases on a thread. Facts interlaced and examined, studied. Everything now is so fast, so fleeting, so “gone tomorrow.” Wherefore art thou, Sagan? Your successor’s practicing his tight five on Late Night. Why can’t we talk about things that matter, we – all who matter – have all invariably asked to no one in particular. I want to talk about the real things, the things affecting people. Who doesn’t? What doesn’t? It’s all so much. So much nothing.


Rule 5, Section 4, Article 3, Item 7

As no doubt countless people who visit this website know, the last three sentences of the 2018 National Football League Rulebook Rule 5, Section 4, Article 3, Item 7 read as follows:

Kicking shoes must not be modified (including using a shoelace wrapped around toe and/or bottom of the shoe), and any shoe that is worn by a player with an artificial limb on his kicking leg must have a kicking surface that conforms to that of a normal kicking shoe. Punters and placekickers may omit the shoe from the kicking foot in preparation for and during kicking plays. Punters and placekickers may wear any combination of the tri-colored shoes provided that the colors are consistent with those selected by the team and with the policy listed above.

No doubt those same countless readers saw that I emphasized a phrase in there that just sticks in my craw every time I set out to read the 2018 National Football League Rulebook. “a kicking surface that conforms to that of a normal kicking shoe” I don’t even like to give the punctuation, let alone dare capitalize the first letter of a phrase like that. It says, in minimally uncertain terms, that Football as a sport is to be played by the National Football League with feet in the arena conforming to a strict set of geometries.

Some say, it may have something to do with this fellow,

,

Tom Dempsey.

See, Tom Dempsey was a special kind of kicker. He is best known for a truly transcendental moment in sports history wherein he kicked a football 63 yards to put the New Orleans Saints up 2 over the Detroit Lions on November 8, 1970. This feat, just belting a football half way across the field through some small uprights, would not be matched until the Clinton administration nor topped (by “a single yard”) until the Obama administration. 

Well, it turns out that Tom Dempsey was we might call “special needs” with a certain kind of “special emphasis” in the words to mask the sting of “disability”. Tom Dempsey was born without toes (or fingers on one hand!). At the time of the field goal, the Later Stages of the Nixon Administration, this meant Tom Dempsey would wear whatever shoes were comfortable and available to him. At some point he settled on that snazzy little number seen in the photograph.

Some thought this conferred an unfair advantage. Seeking such that not one is gotten over on them, they wrote some changes specifically into the rulebook, starting in 1974, because of this guy. Some, like that quoted and emphasized above, stay with the game at least as late as the Later Stages of the Trump Administration.

A pretty tidy summary of the whole situation can be gleaned from the clip below. 

However, as a supporter of doing whatever you can with the body you got, it’s a shame – a shame – that some, out of fear or tired prejudice cannot simply leave possible what is possible. That choose to make a rule, one just as many like it, that say how the (male) body is to become spectacle…to the spectator footing the ESPN bills. That may not have been the best route by which to have this conversation (the question plaguing us even neonatally, “what are feet?” ), nor the most sensible (let alone sensitive) approach to have taken while there, but it’s a rule, in their rulebook, for their sport, so who am I to tell the good people of the National Football League how to conduct their business? Empires got rules and they got thousands of them.

So, indelibly stamped it is. The “normal kicking shoe” having been elsewhere defined. But here, perhaps just because I’m looking for it, perhaps just because I know where it comes from, perhaps just because I know where it can lead, I see that word “normal” and I can’t help but figure, there goes another.


Poor quality of health care was a major driver of excess mortality across conditions

That headline may not be a surprise to many, but it is a central finding of a study entitled “Mortality due to low-quality health systems in the universal health coverage era: a systematic analysis of amenable deaths in 137 countries” by Kruk et al. recently published in The Lancet. Other findings from said article include the estimation of “8.6 million excess death [] amenable to health care,” 5 million of which were due to “poor quality care” and 3.6 million due to “non-utilization of healthcare.” This is out of “19.3 million total deaths in 2016 in LMICs from the 61 specific causes and age groups considered in this study”. Furthermore, the authors estimate that “7.0 million deaths [were] preventable through public health intervention”. That is, in these 61 countries, approximately 15.6 million deaths, 80% of all deaths that year, were due to insufficiencies in healthcare and not because we don’t know how to provide such care.

This is progress of a sort. People dying of cardiovascular disease is something of a sign of a growing middle class, while the respiratory issues (including tuberculosis and chronic respiratory) indicate the direction of motion. That is, more and more people are dying because of “old people” diseases (cancer, sad as it is to say, a sign of a prospering nation), than of “third world” diseases (which also have outweighed significance in Figure 2 with their towering violet bars of “poor quality”).

But, it’s also 15 million people whose lives were cut short because what we know doesn’t always go to where we need it. And 600,000 others who you may have been comfortable with discarding in the approximation to make a point, but upon even the slightest moment’s reflection you realized that to forget that even these 600,000 deaths were entirely preventable based on medical care standards to which we in the “23 high-income reference countries with strong health systems” are accustomed. And but so 15.6 million people could have lived a little longer if we but spread what we know.

And put a little work into it.


Evidence-based recommendations for colleges and universities to consider and adapt to their particular circumstances, or: A tale of available resources

Did you know that the National Academies of Science, Engineering, and Medicine have a digital library platform from which you can get I-[word withheld upon tenure]-you-not thousands of books on a hundred interesting topics? Did you know, you can download and then read those books and understand their take home messages? Just any of them at all. I take at random, “Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine“. The Committee on the Impacts of Sexual Harassment in Academia and/or the Committee on Women in Science, Engineering, and Medicine Policy and Global Affairs offered “the following evidence-based recommendations as a road map for colleges and universities to their particular circumstances” to address “the conditions under which sexual harassment is likely to occur in science, engineering, and medicine programs and departments in academia”:

RECOMMENDATION 1: Create diverse, inclusive, and respectful environments.

RECOMMENDATION 2: Address the most common form of sexual harassment: gender harassment.

RECOMMENDATION 3: Move beyond legal compliance to address culture and climate.

RECOMMENDATION 4: Improve transparency and accountability.

RECOMMENDATION 5: Diffuse the hierarchical and dependent relationship between trainees and faculty.

RECOMMENDATION 6: Provide support for the target.

RECOMMENDATION 7: Strive for strong and diverse leadership.

RECOMMENDATION 8: Measure progress.

RECOMMENDATION 9: Incentivize change.

RECOMMENDATION 10: Encourage involvement of professional societies and other organizations.

RECOMMENDATION 11: Initiate legislative action.

RECOMMENDATION 12: Address the failures to meaningfully enforce Title VII’s prohibition on sex discrimination.

RECOMMENDATION 13: Increase federal agency action and collaboration.

RECOMMENDATION 14: Conduct necessary research.

RECOMMENDATION 15: Make the entire academic community responsible for reducing and preventing sexual harassment.

Just like that, simple. Pick up a book, read it, learn something new. Then do something with it.