Search the KHIT Blog

Tuesday, September 18, 2018

Hashtag #health2con

Hate to have to miss the Conference this year, but you can easily follow near- real time twitter updates here:

THE Health IT event of the year.

More to come...

Thursday, September 13, 2018


"This volume presents a comprehensive overview of the science and application of the Exposome through seventeen chapters from leaders in the field. At just over ten years since the term was coined by Christopher Wild in 2005, this is the first, field-defining volume to offer a holistic picture of the important and growing field of Exposomics. 

The term “Exposome” describes the sum of all exposures (not only chemical) that an individual can receive over a lifetime from both exogenous sources (environmental contaminants, food, lifestyle, drugs, air, etc.) and endogenous sources (metabolism, oxidative stress, lipid peroxidation, chemicals synthesized by the microbiome, etc.). The first section of this book contains chapters that discuss how the Exposome is defined and how the concept fits into the fields of public health and epidemiology. The second section provides an overview of techniques and methods to measure the human Exposome. The third section contains methods and applications for measuring the Exposome through external exposures. Section four provides an overview on statistical and computational techniques- including big data analysis - for characterizing the Exposome. Section five presents a global collection of case studies."
 A.K.A. (or closely related to) "epigenomics?" How about "HGT?" (Horizontal Gene Transfer). Where does that fit? Related to "the Upstream?" 

And, again how will all of this fit into the exam room / bedside patient encounter in the "productivity treadmill" front-line world?

 Got onto this topic via STATnews:

From the moment of conception onward, genes control our development and health. But they don’t do it alone. The exposome — all the internal and external chemical exposures we experience during the course our lives — influences, for better or worse, the genes and proteins they code for. A better understanding of the exposome, a concept still in its infancy, will help identify how nongenetic factors influence biological reactions and possibly the development of chronic diseases...

AGAIN: SEPT 16TH - 18TH, 2018

THE Health IT event of the year.
Be there. I will hate to miss this. Applied for my usual press pass. Never heard back, but, it's likely moot, given my post-op convalescence (which is proceeding apace, thought the daily conference schlep might be a bit much for me at this point).

More to come...

Tuesday, September 11, 2018

My cardiac surgeon

I had my first follow-up office visit today in the wake of my SAVR px. All signs looking good. I asked Dr. Veeragandham whether he would mind my citing him here on the blog. I didn't want to presume. He gave me the green light.

I owe my life to this man and his team at John Muir Cardiovasular Institute (inclusive of the support teams staffing the ICI and PCU).

As I was in pre-op on the 23rd, someone remarked, "oh, you got the A Team."

No exaggeration. Not one whit. Back in June when I had my hernia px, my anesthesiologist said of Dr. V., without hesitation, "if I needed to have something done, he'd be my guy."

I asked Dr. V. about "pumphead." He replied convincingly to not worry about it. I joked "how would I even know? I stay confused as it is."

He also told me I'd be OK to drive again in another week (I'm in no hurry).

You gonna need cardiac surgery? You simply can't do any better, IMO. Both in terms of technical skills and effusive beneficent humanity.
I just filled out my Press-Gainey. Gave 'em all high marks.
Some prior posts alluding to my SAVR anticipation and experience here.

SHORTLY: SEPT 16TH - 18TH, 2018
THE Health IT event of the year.
Worth every penny.

apropos of the Conference and "innovation," a book I just finished.

Nicely done. More ASAP

More to come...

Sunday, September 9, 2018

SAVR px progress

Prior to surgery I could max out the spirometer repeatedly with ease. Then, post-op, in the ICU and PCU (Progressive Care Unit), I could barely move it.

I'm now back to pinning it at 2,500 ml multiple times in a row here at home. Doin' OK. Vitals are stable (resting pulse is rather high, though), I'm out walking about 1/3rd mile at a time. Way less pain than I'd expected. Lost about 16 lbs. Fine with that. Two f/ups this week, my surgeon and cardiologist. Should be interesting.

One of my new reads:

Science Magazine book reviews are gonna bankrupt me, LOL...

THE Health IT event of the year.
Be there.



Can't say enough good about this production.

More to come...

Tuesday, September 4, 2018

Coming soon, the 2018 Health 2.0 Annual Conference

Indu and Matthew, 2017 Conference
In my email inbox today.
Hello there!

With our flagship Fall Conference just three weeks away, we’re getting very excited to see you there! Health 2.0 is where accountability reigns and truth gets a platform. Our community of health care rabble rousers continues to raise the bar and create a global movement of innovation. With our signature candor, we promise to highlight the big ideas and untangle the tough questions. This year we’ll be asking each other and all of you…
1. Matthew: Is this the year the bubble bursts? 
Indu: Maybe it’s not a bubble.  Maybe this is exactly the level of investment we need to get to the change and real value creation we need.  I’m bullish.

Matthew : Maybe to change a $3.5 trillion industry, it’s not enough….yet. Could use a few more IPOs though….
2. Indu: Is blockchain BS?
Matthew: Well my bitcoin is down 50% since I boasted to you how rich I was in January! But Deloitte says 75% of health care execs say their understanding of blockchain is “excellent,” 39% say it’s in their top 5 priorities but only 11% say they are deploying blockchain somewhere in their enterprise. I actually think that’s quite high!
3. Indu: Is everyone just giving value-based care lip-service? A survey by the American Medical Group Association in 2015 showed that payments from commercial payers were still heavily Fee for Service, 78%. And another 2016 survey showed that only 43% of physicians’ compensation is tied to quality or value!
Matthew: Well I did a survey on this very topic in 1997 at the height of the managed care revolution--only about 10% was NOT fee for service then. So we have seen some change.
Indu: Not enough.
4. Indu: Will Blue Button 2.0 move the needle forward?  
Matthew: Still not sure what was wrong with Blue Button 1.0! But nearly 1,000 developers are using the CMS sandbox and insurers are participating in the CARIN Alliance. As Stephen Stills sang, "there’s something happening here…”
5. Indu: Is Seema Verma correct that the end of the fax machine is near?
Matthew: Not per my last experience with my kid’s pediatrician...but I’m hopeful. She did say 2020.
6. Matthew: Is Amazon’s health care takeover our golden ticket?  
Indu: Depends on what you mean by “our?”  I don’t think Amazon is going to kill the digital health tech market, if anything I think it enriches the market with new supply chains and a new standard for customer experience and competition. I do think it stands to hurt health systems.  But health systems have had lots of lead time to respond and consolidation in that sector hasn’t helped cost structures or outcomes.  So what else could they be doing? Come to the conference and find out ;)

Matthew: I agree with all that, but you did say “digital health”. Grrr.
7. Matthew: Will free medical school actually alleviate the global physician shortage and encourage the right kind of physician experience?
Indu: No, but it’s a start. We have to humanize the experience of training and practicing so clinicians don’t burn out.
Matthew: Like you did?
Indu: If I hadn’t left medicine, we wouldn’t be working together!
Matthew : So I’m responsible for humanizing you? Or hasn't that happened yet?
8. Matthew: Is the Opioid epidemic a data problem or a social one?
Indu: Yes. But seriously, we have an incredible segment on this on the Unacceptables. Basically complex problems require ecosystem solutions and technology can be the connective tissue here.
 9. Matthew: How are the dinosaurs of old school care delivery adapting to tech disruptors?
Indu: They’re turning into birds!
10. Indu: Is digital health dead?
Matthew: The term digital health is the zombie I can’t quite kill!
We’re not new, and it takes a lot to impress us. Now in our 12th season, with a close eye on trends and a heavy hand in curation we’ve set the stage for another class of investments, partnerships, and launches to bring you into 2019 and beyond.
Join us this September 16-18 in Santa Clara. As a friend of ours, feel free to use the code VIP for $200 off! We can’t wait to see you there.

Indu Subaiya & Matthew Holt


THE Health IT event of the year.
I will miss you all this year. My post-op recovery is going along pretty well, but I doubt I'll be up to attending.

More to come...

Wednesday, August 29, 2018

SAVR px post-op discharge week

I'm home. Discharged at 2 pm yesterday. Thanks to everyone for your kind words of concern and support.

Well, that was indeed interesting. Lots to think about and recount as I gather my thoughts. Stay tuned.

For now, Major Props to my surgical team and all of the Muir Concord Cardiovascular center staff.


THE Health IT event of the year.
I don't guess I'll be attending this year (I've covered the past six). I applied for the press pass, but never got a response, but, as a practical matter I doubt I'd be physically up to it. Hate to miss it.


RIP Senator John McCain.

Whatever you thought of his politics (and I was mostly not a fan), he served courageously, and suffered mightily for our country.


My offending aortic valve. Quite frankly, I'm lucky to be alive. There was probably heart valve failure or a stroke in my not-to-distant future.

I'm having a lot to continue to adjust to at home this week (a lot of it related to fastidious antiseptic hygiene measures). I'm out walking every day. Reading a lot. Tire easily. Vitals are stable.

My medical economist and writer pal JD Kleinke has warned me about the risk of "pump brain." Yeah, bro', I saw that in my Dad after his heart surgery in 1996.

Among my frustrations is that I will not be able to play my guitar for another 6-8 weeks (sternum pressure). Grrrr...
On a terribly sad note, I got a call from my close Seattle friend "Joey T's" cell yesterday. It was his wife Kathy, calling to say he'd died the other day from brain mets stemming from his bladder cancer. He'd been doing better of late, but things took a rapid turn south. Joey and I had talked at length about his cancer repeatedly. I knew he'd been struggling. Nonetheless he showed up unannounced at Danielle's Memorial. That is a friend.
Very sad.

SAVR the experience. 

Up at 3:45 a.m., after a difficult, anxious, short night's sleep. No foods of liquids allowed. Ugh. Off to Concord, arriving at the Cardiovascular Institute at 5:23. Preregistered, straight up to “Short Stay” on the 2nd floor to begin pre-op prep. First (after vitals and a bunch of Consent signatures), neck-to-ankles full-frontal body shave (“OMG! I’m a Foster Farms Thighs & Breasts Valu-Pack!), then blood draws and chest x-rays. IV insertions next (both arms), and EKG telemetry hookups follow forthwith.

Quick discussions ensue informing my wife and sister as to where to go to wait and what to expect in the way of surgery progress notifications. The anesthesiologist comes by to introduce herself and chat reassuringly. My cardiac surgeon stops by to warmly greet and further encourage me. Cardiac staffers would subsequently remark, on multiple occasions, “boy, did you ever get the A-Team!”

All good to hear. My anxiety is pretty minimal, all things considered, but it would not be true to claim there wasn’t any. I guess I’ll wake up. Or not.

More prep — lost of stuff going on all around me in tandem — and then it’s off to the OR.

They sidle my gurney up aside the operating table, which has a large stainless steel hump on it. I’m instructed to slide over on to it, with my upper-mid back positioned over the hump. It’s uncomfortable…

That’s the last thing I remember until waking up several hours later in Cardiac ICU (it seemed like mere minutes). Eventually the intubation is removed, I and have episodic bouts of harsh coughing. Right away they push me to begin using the spirometer. Pre-op I’d been pinning it at 2,500, no sweat. Now I can barely get it to move.

In short order I start intractable bouts of rather harsh, persistent hiccups from my irritated windpipe, some of which last 2-3 hours at a time through Saturday. Nothing works to abate it. They finally resort to two sequential IM doses of thorazine, which knock me out.

I will never EVER do thorazine again. You can just forget it. The most vivid adverse side effect was my mouth feeling like the surface of planet Mercury. Bone dry. By Saturday evening I was totally exhausted.

But, that aside, rehab progress began right away. Sitting up, doing minor PT extremities’ exercises, then standing, then a walk down the hall using a walker.

By Saturday I’m moved from ICU down to the PCU (Progressive Care Unit). I quickly regain my “sea legs” and start stably lapping the PCU floor around the nurses’ stations, doing 4-6 laps at a time rather than the expected one or so.

Struggle to eat. Hospital food, man, particularly for us cardiac pts. Like eating cardboard. Ugh. I struggle to down some chow that I know I need.

By Monday, the tentative talk is that I might be able to go home Tuesday (thought my surgeon equivocates a bit). Those damned hiccups have cost me at least one additional post-op inpt day.

On Tuesday, though, the consensus on Rounds (my surgeon, my cardiologist, and his on-call practice colleague) is that yeah, I’m good to go.

More reams of paperwork, and then a protracted hurry-up-and-wait interval.

Finally, at 1:50 pm, an aide with the requisite wheelchair comes for me. Loaded into the car curbside, I have to sit in a back seat (airbag risk).

Homeward bound. Pretty happy camper at this point.

I can’t say enough good about my entire care team.

Some thoughts about my workflow observations shortly (yeah, I can't help it, I'm always watching and counting). Stay tuned.

More to come...

Monday, August 20, 2018

SAVR px week

Thursday morning I'm getting my severely stenotic aortic valve replaced (via the "old-fashioned" open-heart SAVR px, same one my late Dad had 22 years ago at age 80). I am out of time. I've pushed the envelope all the way, owing mostly to Danielle's illness. See "My 'Check Engine' light." So, I'll probably be off line for a bit. Friday is likely to be a crappy day in the cardiac ICU. I'm told to expect 4-8 days in the hospital, depending on my post-op progress.

Interesting: During my pre-op visit last Thursday, among the many tests they ran on me was a nasal swab for "Staph au."

Then I ran across this in a book I just started:
...the global medical challenge of antibiotic-resistant bacteria, a quiet crisis destined to become noisier. Dangerous bugs such as MRSA (methicillin-resistant Staphylococcus aureus, which kills more than eleven thousand people annually in the United States and many more thousands around the world) can abruptly acquire whole kits of drug-resistance genes, from entirely different kinds of bacteria, by horizontal gene transfer. That’s why the problem of multiple-drug-resistant superbugs—unkillable bacteria—has spread around the world so quickly. By such revelations, both practical and profound, we’re suddenly challenged to adjust our basic understandings of who we humans are, what has gone into the making of us, and how the living world works.

Quammen, David. The Tangled Tree: A Radical New History of Life (Kindle Locations 65-71). Simon & Schuster. Kindle Edition.

My assays were negative. The pre-op nurse had told me that the general environmental staph contamination prevalence was now at about 30% (meaning, were you to touch anything randomly while out in public, you'd have ~30% chance of coming in contact with the staph bug).

More on David Quammen's book here, from Science Friday. Looks like a great read. "HGT?" (Horizontal Gene Transfer). Great. Add one more complex phenomenon to the "Omics" pile for medical science and practice to have to weed through.



Yeah. I've talked to a bunch of my friends who've been through Open Heart px's. Comforting.


From Science Based Medicine:
Bouffant caps versus skull caps in the operating room: A no holds barred cage match
Over the last few years, AORN and the American College of Surgeons have been battling it out over AORN’s 2014 guideline that has increasingly led to the banning of the surgical skull cap in the operating room in favor of the bouffant cap. Lacking from this kerfuffle has been much in the way of evidence to support AORN’s guideline, but unfortunately that didn’t stop the ACS from appealing mainly to tradition and emotion in objecting to it...
I guess I'll be looking.



THE Health IT event of the year.

More to come...

Thursday, August 16, 2018

Pancreatic cancer claims another one

Rest in peace, Aretha Franklin

Died at home, in hospice care. We know it all too well. She and our Danielle shared similar risk factors.

Only 76. Very, very sad. Our hearts go out to her family. This old washed-up guitar player knew her music so well.

More to come...

Monday, August 6, 2018

EBM and the SOAP process

Interesting inexpensive resource ("EBM," Evidence-Based Medicine -- as opposed to "Eminence-Based Medicine"):

This short book provides the skills and tools to empower the reader to make better sense of clinical evidence. Present-day journal articles reflect ever-increasing complexity in research design, methods and analyses, and this welcome addition to the field will help readers to get the most from such papers.

With a little practice the book will indeed make it easier to understand the evidence related to healthcare interventions; it provides a clear and accessible account across the whole subject area. The authors avoid unnecessary jargon and have designed the book to be flexible in its use – it can be read from cover to cover or dipped into for specific topics.

Clinical Evidence Made Easy is helpfully structured into two main sections. The first provides the reader with the necessary skills underpinning evidence-based practice, the second gives invaluable tools for appraising different types of articles together with practical examples of their use. Moreover, the configuration within the sections makes for easy reading: common headings are used across chapters so that the reader quickly becomes familiar with the structure and the way ideas are presented.

This is a great book for busy clinicians who want to learn how to deliver evidence-based practice and have at their fingertips the tools to make sense of the burgeoning research literature. Indeed, it will also be valuable for those engaged in research, to aid the planning and delivery of their own projects.

This book is designed for healthcare professionals who need to know how to understand and appraise the clinical evidence that they come across every day.

We do not assume that you have any prior knowledge of research methodology, statistical analysis or how papers are written. However basic your knowledge, you will find that everything is clearly explained.

We have designed a clinical evidence appraisal tool for each of the main types of research method. These can be found in the second section of the book, ‘Clinical evidence at work’, and you can use them to help you evaluate research papers and other clinical literature, so that you can decide whether they should change your practice…

Harris, Michael; Harris, Michael; Taylor, Gordon; Taylor, Gordon; Jackson, Daniel; Jackson, Daniel. Clinical Evidence Made Easy. Scion Publishing. Kindle Edition. 
I am liking it. Fairly comprehensive topical coverage.

Understanding clinical evidence
1. The importance of clinical evidence
2. Asking the right questions
3. Looking for evidence
4. Choosing and reading a paper
5. Recognizing bias
6. Statistics that describe
7. Statistics that predict
8. Randomized controlled trials
9. Cohort studies

10. Case–control studies
11. Research on diagnostic tests
12. Qualitative research
13. Research that summarizes other research
14. Clinical guidelines
15. Health economic evidence
16. Evidence from pharmaceutical companies
17. Applying the evidence in real life

Clinical evidence at work

18. Asking the right questions
19. Choosing the right statistical test
20. Randomized controlled trials
21. Cohort studies
22. Case–control studies
23. Research on diagnostic tests
24. Qualitative research
25. Research that summarizes other research
26. Clinical guidelines
27. Health economic evidence
28. Evidence from pharmaceutical companies
29. Putting it all together…

* They fail to fully make clear whether "external clinical evidence" refers only to that of clinical literature, and does not include patient exam and testing data. I have to assume that eval of exam room/bedside data comes under "clinical expertise."

More broadly. "evidence" is information (typically comprising lexical/discoursive and more structured alphanumeric "data") that makes a true conclusion more likely (or, more rarely, constitutes dispositive "proof").
A "fallacy" is any assertion purporting to contain "evidence" but in fact does not. Fallacies are legion, both structural/formal, and "informal/rhetorical." Also worth noting here are the numerous "cognitive biases" that chronically afflict our ability to "reason" accurately. I have long been a student of this stuff, and spent a number of fun years teaching post-secondary "Critical Thinking."


Subjective - Objective - Assessment - Plan

Simple example here.
NOTE: My former Sup in the Meaningful Use program, Keith Parker, argued that "SOAP" should properly be "SOAPe" ("e" for Evaluation). Scroll down in this post. He's right.

A cute, brief YouTube SOAP note video:


"CHEIF COMPLAINT"? Lordy. Nonetheless...

A couple more of my graphic riffs on the process.

"SOAP Note" on the wiki.

I've noted the point many times that there's a lot going on in the exam room, usually with insufficient time for deeply deliberative assessment given the still-dominant economic regime of the "Productivity Treadmill."


Search the text for "SOAP." Nothing. Search the text for "Bayes" and "Bayesian." Nothing.
(Nothing either for "exam," "differential," "rule out," "digital," "EMR," "EHR," "electronic.")
"P Value?"

23 hits. to wit,
The P value

The P value gives the probability of an observed difference having happened by chance.

P = 0.5 means that the probability of a difference having happened by chance is 0.5 in 1, or 50%.

P = 0.05 means that the probability of the difference having happened by chance is 0.05 in 1, or 5%. This is the level when we traditionally consider the difference to be sufficient to reject the null hypothesis.

The lower the P value, the lower the likelihood that the difference occurred by chance and therefore the stronger the evidence for rejecting the null hypothesis and concluding that the intervention really does have a different effect. As the P value that is normally used for this is 0.05, when P < 0.05 we can conclude that the null hypothesis is false…
[op cit, pg 38]
Yeah. That's the way they continue to teach it. Way simplistic. First a "p value" is a probability estimate, one that will also yield a variability distribution in the wake of repeated trials. Second, it assumes a perfectly Gaussian distribution (bell curve). See a 1996 ASQ newsletter column of mine, "Probability from 'C' to 'G'." (pdf)

I worked in credit risk modeling and management for five years (large pdf link). We never took p-values and distributional assumptions at face value. The name of the game was (and is) stress-tested expected value computations. We made successive record profits every year I was there. (Wrote about that time in my life here.)
In fairness, the authors do make one brief cite concerning a statistical test useful for "skewed data." But, just one simple example.

I've not read the book closely yet, but I have skimmed the chapters, and I do like what I find therein. Every chapter closes with a "Putting it all together" closing paragraph or two. It's really about assessing the "external clinical evidence" originating beyond the exam room or patient bedside.

I am a regular at SBM, the "Science Based Medicine" blog. You might like the search results there for "Evidence-Based Medicine."
There is a bit of pedantic nit-picking out there as to whether EBM differs materially from SBM. I don't think so. From the SBM site:
"Good science is the best and only way to determine which treatments and products are truly safe and effective. That idea is already formalized in a movement known as evidence-based medicine (EBM). EBM is a vital and positive influence on the practice of medicine, but it has limitations and problems in practice: it often overemphasizes the value of evidence from clinical trials alone, with some unintended consequences, such as taxpayer dollars spent on “more research” of questionable value. The idea of SBM is not to compete with EBM, but a call to enhance it with a broader view: to answer the question “what works?” we must give more importance to our cumulative scientific knowledge from all relevant disciplines."

Again, "Evidence" -- "that which makes a true conclusion more likely." It behooves us keep in mind that evidence itself spans a distribution, e.g.: "nil - weak - indeterminate - likely - dispositive." Gets even hairier when you add in "conjuncts" i.e., "given this and that, and that over there..." (just for starters).

I think about this stuff all the time. But what spurred this post in particular was this cool Atlantic article:

Yeah. Which returns me to this book I've been studying. Cited it earlier.

Below, another one I need to report on. Goes to the EBM thing.

Beyond those, a number of additional recent books inform my thinking (many of which I've cited on the blog before):
The Enigma of Reason
The Knowledge Illusion
The Distracted Mind
The Secret Life of the Mind
Touching a Nerve
World Without Mind
How to Think
Big Mind
The Book of Why
Snowball in a Blizzard
How Doctors Think
Thinking, Fast and Slow
Moral Tribes
More Harm Than Good
Changing minds
Levers of Influence
How to Change Your Mind
Being Wrong
There are more, but this will do for now on the topics relating to cognition. My long-time abiding interest goes to improving diagnostic (and px/tx) reasoning via understanding and explicating the salient aspects of rational clinical cognition. Inextricably intertwined with this is an understanding of the relevant aspects of Health IT. To the extent that the latter impedes the former (poor UX), well (as many complain), it contributes to adversity.


18 days 'til my heart surgery. Keep singing "woke up this mornin'..." 18 more times.


apropos of continuing to wake up, saw a post about this book over at THCB.

Amazon link here. Looks interesting. I am reminded of Ann Neumann's book The Good Death.


Interesting. Stay Tuned. Source, a WIRED article.

More to come...

Wednesday, August 1, 2018

My "Check Engine" light

My mental dashboard "Check Engine" light has been blaring "on" continuously since early 2017. Or, to use another apt metaphor, I've been on

for about 19 months. SAVR px

After spending most of 2015 dealing with prostate cancer (successfully, it would thus far seem), by 2016 I was back on my Trek racing bike and back in the gym, lifting weights and holding my own at full-court pickup hoops with guys half to a quarter my age (I was 70 at the time). Mr. No-Hops, a Legend in His own Mind. He of the 6-inch Vertical, who moves in geologic time. He of the Wax Museum D...

GDaddy and the Grandson at City Sport, 2016
Dr. Daniel Kraft (cited here recently) is a fan of the "dashboard" metaphor when it comes to health monitoring apps. See a brief video featuring him, "A Virtual Dashboard of our Health." 

Cool guy. He's in a ton of videos over on YouTube.

My "Check Engine" light thing is more mundane. I don't think there are any "apps" for my evolved condition.

In January 2017 our beloved 15 yr old rescue dog Jaco was diagnosed with a large terminal tumor in his abdomen. We'd had him since we found him on a freeway ramp in Las Vegas in 2003. He was the sweetest.

The vet gave him a month or two. In late February, after monitoring him closely day-by-day, hour-by-hour, I finally had to have him put down.

Earlier in February, on the 7th, My dear old Seattle area friend of 44 years (and former bandmate, world-class drummer) Kurt Kolstad succumbed after a 12-year battle with Mantle Cell Lymphoma. Several years earlier his wife died from COPD. Too much, man, too much.

Then, on March 29th, 2017, "the dx from hell" arrived. My younger daughter was found to have Stage IV metastatic pancreatic cancer. She would live until April 27th, 2018 after a year of chemo regimens followed by 6 weeks of home hospice care here at our house.

During this time, I'd gotten a new Primary at Muir. During my first exam he told he he detected a heart murmur. He quickly looked in my chart and found my 2015 cardiac echo px (done while I was in the hospital for sepsis after my prostate biopsy). The echo result had been deemed "subclinical," but my new doc referred me to a cardiologist for closer review and follow-up.

A treadmill EKG study and series of echoes ensued ("active surveillance"), and my aortic valve condition continued to decline significantly. My dx now is "severe aortic stenosis," and I'm now scheduled for a SAVR valve replacement px in late August (ineligible for a "TAVR" but I'd decided against it anyway). I had a coronary angiogram done earlier this year, negative for blockages -- "you have the arteries of an 18 yr old" (that's gotta be my decades of gym rat hoops).

The constipating stress of Danielle's illness also surely played a role in my getting a large inguinal hernia. It got worse and worse, but cardiology refused to greenlight me for abdominal surgery, citing anesthesia risk, given my heart problem. Gotta fix the valve first. Eventually they relented, with the stipulation that I have a cardiac anesthesiologist present at the hernia scope job. Done.

That could not have gone better.

Now it's time for the Big Show. My recent chest CT confirms no aorta problem or other proximate issues, just a seriously bad valve.

I've been putting this off during Danielle's illness, and now until after my Grandson's August 10th wedding in Las Vegas, where he lives. Had it not been for these circumstances, I'd have had the SAVR px months ago. I feel like I've pushed the envelope all the way out.

Sometimes I feel like the stress of all of this has taken at least 5 years off my remaining life. I am so ready to be over all this. It's likely that I will have to miss the Health 2.0 Conference this year. I may not be cleared to drive by then. (Candidly, I'm not sure that my conference coverage M.O. is all that distinct any more, now that everyone is carrying smartphones with great optics for real- and near-real time WiFi internet sharing.)

If I don't see you there, have a great time.


THE Health IT event of the year.

More to come...

Saturday, July 28, 2018

BioMed Sector: the Bleeding Edge

My wife alerted me to this.

"What you don't know, can hurt you. From the Academy Award® nominated filmmakers Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground) comes a groundbreaking investigation into the crimes of Big Medical. America has the most technologically advanced health care system in the world, yet medical interventions have become the third leading cause of death, and the overwhelming majority of high-risk implanted devices never require a single clinical trial."
Film Review: ‘The Bleeding Edge’
Kirby Dick's disturbingly powerful exposé of the medical-device industry nails a corporatized America that has stopped taking care of its citizens.

If you watch enough passionate muckraking social-justice documentaries, or simply listen to the news every day, you may feel like you’ve lost the capacity to be shocked. But “The Bleeding Edge,” Kirby Dick’s disturbingly powerful and important documentary about the medical-device industry, contains a line near the end that truly shocked me, because it defines, with a word (in fact, three little letters), what’s happened to America.

The movie is about an industry that now generates revenues of $300 billion a year by producing and marketing the highly sophisticated utensils and apparatuses that get implanted into people’s bodies. (Over the last decade, 70 million Americans have been outfitted with internal medical devices.) It’s also about the scandalous and clandestine inhumanity of those companies. There are, of course, many devices that save lives and vastly uplift people’s daily welfare: pacemakers, hip replacements, cornea transplants.

The film doesn’t deny any of this; it never paints its indictment with a broad brush. But it focuses on a handful of devices that have caused toxic levels of harm to the trusting victims who’ve used them, and the scandal — which is ongoing — is that the devices were never properly tested. In essence, the corporations put them out there and said, “What the hell, let’s give this a try!” The people who used the devices became human guinea pigs (just like the women who took thalidomide in the late 1950s), and when they began to develop symptoms of harm, they had no idea what was happening to them. Even when they started to figure out the source of their symptoms, there was little or no recourse and (in many cases) no way to reverse the damage…
Interesting. About a month hence I will be the SAVR px recipient of a biomedical device, a prosthetic bovine aortic valve.

I recently finished watching the moving HBO documentary on the late Robin Williams ("Come inside my mind"). I'd not been aware that he'd had a SAVR:

What a terrible loss.

I never got to meet him. That would have been so cool. We have a mutual connection.

We have NetFlix here, will have to pull up The Bleeding Edge and watch it. Stay tuned.


We pulled The Bleeding Edge up on NetFlix and watched it in its entirety in rapt attention. It is a must-see.

Compelling. Infuriating.

Again, a must-see documentary. Below, from the website:
The Facts in The Bleeding Edge

The medical device industry has responded to the malfeasance exposed in our investigative documentary The Bleeding Edge.

Here are the facts:

The facts set forth in The Bleeding Edge are accurate and have been rigorously vetted by extensive research and multiple experts.

Bayer claims the portrayal of its harmful birth control device Essure in The Bleeding Edge “lacks scientific support” and is “inaccurate and misleading.” These claims are false.

The truth is that Essure was approved under an “expedited review” without randomized, nonblinded studies or a comparator group. These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime. Some of the patient forms in the Essure studies were altered to reflect a more positive outcome than what was reported by the patient. Conceptus, the original manufacturer of Essure purchased by Bayer, hid more than 32,000 adverse events regarding Essure from the FDA.

Bayer’s attacks on three of the experts in The Bleeding Edge are without substance. There are no conflicts of interest regarding any of the experts in our film.

Dr. Diana Zuckerman is president of the non-profit National Center for Health Research (NCRH.) As an expert witness discussing her survey of Essure patients, she requested that the plaintiff’s attorney pay $375 to the NCRH. This represents no conflict because she says nothing about Essure in the film. Dr. Zuckerman has been quoted in the New York Times, the Washington Post and other media describing the need for well-designed, long-term research on Essure.

Dr. Julio Novoa is an experienced OB-GYN who surgically removes Essure from women who have been harmed by the device. For Bayer to suggest that he has “a financial interest in recommending the removal of the product” because he is being paid for doing his job is both cynical and false. Madris Tomes, a former public health analyst for the FDA, provides FDA public data and trends of adverse event reports to clients. Tomes has provided data expertise to the Essure Problems Facebook group pro bono.

On July 20, one week before The Bleeding Edge was released on Netflix, Bayer announced it would stop selling Essure after 2018.

In response to the film, Johnson & Johnson stated “providing safe and effective products is always our top priority.” This is contradicted by the fact that they released cobalt metal-on-metal hips as well as pelvic mesh despite knowing that there were significant safety risks with both.

Court records show that in 1995 a scientist from DePuy, whose parent company is J&J, warned about the dangers of their cobalt metal hip. After it was put on the market, surgeons, researchers and health officials repeatedly informed J&J that their hip device was harming patients, but it wasn’t until 2010 that J&J finally recalled the product, after it harmed tens of thousands of people.

Additionally, court records show that J&J also knew their pelvic mesh would injure women, but J&J chose to put the device on the market anyway. There are now tens of thousands of lawsuits filed against them by women harmed by mesh.

In response to the film, the FDA stated, “Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice.” This is far too late. To protect Americans, the FDA must establish that a device is safe before it is put on the market.
The FDA claims that it has taken “many steps” in recent years regarding Essure, but the FDA never took the most important step: recalling this flawed and dangerous device from the market in the U.S., especially after it had been taken off the market in the rest of the world.
The FDA, Bayer, Johnson & Johnson all declined to be interviewed for the film.

From The Union of Concerned Scientists:
Drug and Medical Device Companies Have Outsized Influence on FDA
$700 million in lobbying buys significant access

As Congress decides the influence that pharmaceutical, biotech and medical device companies should have over the Food and Drug Administration (FDA), industry spends big.

Data compiled by the Center for Responsive Politics and commissioned by the Union of Concerned Scientists show that between 2009 and 2011, prescription drug, biotechnology and medical device companies spent more than $700 million lobbying Congress and the Obama administration.

That’s a lot of money. By comparison, the insurance industry spent $480 million in the same period. Drug companies alone spent more than $487 million on lobbying during the three-year period; biotechnology and medical device companies spent $126 million and $86 million, respectively.

Over the same period, elected officials on a House subcommittee and a Senate committee with oversight over FDA received nearly $6.3 million in campaign contributions from these industries. Donations went to both Republicans and Democrats.

Explore the major findings from our investigation and see all of the data we relied upon…
In a recent book review post, "Overcharged: paying for health care," we looked at U.S. exorbitant cost issues. Here's an excerpt from the book:
“How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy?” We offer three reasons. First, doctors had a theory suggesting that the filters should work. Second, once the practice of using filters gained a following, doctors simply “assumed that there was strong evidence for their use.” Why else would so many doctors have put so many filters in so many patients? Third, Medicare, Medicaid, and other payers covered the procedures. In hospital settings, Medicare paid $3,300 for filter insertion, $2,600 for filter repositioning, and $2,600 for filter removal. When these procedures were performed in a doctor’s office, the fees were $2,800, $1,800, and $1,750, respectively. Treatment patterns got well ahead of the science. When the science finally caught up, there was a large financial incentive not to reverse course.

AUCs and other professional guidelines are pointless unless they limit practitioners’ discretion and prevent them from recommending aggressive treatments too often. The tendency to overprescribe reflects a confluence of factors: physicians’ strong desire to help, their belief in the efficacy of their tools, and, of course, the strong financial incentive to perform procedures. As Dr. Redberg put it when discussing the epidemic of overstenting, “It’s like asking a barber if you need a haircut. To an interventional cardiologist, stents are good for almost everyone.”

Charles Silver & David A. Hyman. Overcharged: Why Americans Pay Too Much for Health Care (Kindle Locations 2340-2351). CATO Institute.
Interesting. BTW, searching "FDA" in the book netted 87 hits, nearly all of the textual references using the acronym critical.


THE Health IT event of the year.

Saw news that Alan Alda has gone public with his having Parkinson's. He remains unfazed, and continues with great work (that I have to sheepishly admit to not having been aware of).

"The Alan Alda Center for Communicating Science empowers scientists and health professionals to communicate complex topics in clear, vivid, and engaging ways; leading to improved understanding by the public, media, patients, elected officials, and others outside of their own discipline..."
I registered. This is important stuff.

More in a forthcoming post. For now, relatedly, see my prior post "A case for interdisciplinary science."

More to come...