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The EBM Wars: When Evidence has a Price – The ECMO Trials (Part 2)

By ANISH KOKA

The year was 1965, the place was Boston Children’s and a surgery resident named Robert Bartlett took his turn at the bedside of a just born baby unable to breathe.  This particular baby couldn’t breathe because of a hole in the diaphragm that had allowed the intestines to travel up into the thoracic cage, and prevent normal development of the lungs.  In 1965, Robert Bartlett was engaged in the cutting edge treatment of the time – squeeze a bag that forced oxygenated air into tiny lungs and hope there was enough functioning lung tissue to participate in gas exchange to allow the body to get the oxygen it needed.  Bartlett persisted in ‘bagging’ the child for 2 days.  As was frequently the case, the treatments proved futile and the baby died.

The strange part of the syndrome that had come to be known as congenital diaphragmatic hernia was that repairing the defect and putting the intestines back where they belonged was not necessarily curative.  The clues to what was happening lay in autopsy studies that demonstrated arrested maturation of lung tissue in both compressed and uncompressed lung.  Some systemic process beyond simple compression of one lung must be operative.  It turns out that these little babies were blue because their bodies were shunting blood away from the immature lungs through vascular connections that normally close off after birth.  Add abnormally high pressures in the lungs and you have a perfect physiologic storm that was not compatible with life.

Pondering the problem, Bartlett wondered if there was a way to artificially do what the lungs were supposed to do – oxygenate.  Twelve years later in 1977, while most pediatric intensive care units were still figuring out how to ventilate babies, a team lead by Bartlett was using jerry rigged chest tube catheters to bypass the lungs of babies failing the standard treatments of the day.  In a series of reports that followed, Bartlett described the technique his team used in babies that heretofore had a mortality rate of 90%.  A home made catheter was placed in the internal jugular vein and pumped across an artificial membrane that oxygenated blood before it was returned via a catheter to the carotid artery.  The usual hiccups ensued.  The animal models didn’t adequately model the challenges of placing babies on what has come to be known as ECMO (Extra Corporeal Membrane Oxygenation).

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Patient 1 developed a severely low platelet count, hemorrhaged into the brain and died. Patient 2 survived but was on a ventilator for 7 weeks.  Patient 3 developed progressive pulmonary hypertension and died.  Patient 4 died because of misplacement of one of the ECMO catheters.

The team improved, and mortality in this moribund population improved to 20%.  The pediatric journals of the day refused to publish the data because they felt ECMO for neonates was irresponsible.  Once published, the neonatology community came out in force against ECMO, and some penned editorials implying the children only became supremely ill because Bartlett’s team was incompetent.  The team persisted, as is anyone that is driven by the desperate need of patients.  None of this should be surprising.  The constant battle between skeptics and proponents is a recurring theme known to anyone with even a limited understanding of  medical history.  But this is where the story goes off the rails.Continue reading…

The EBM Wars: Manufacturing Equipoise (Part 1)

By ANISH KOKA

The phone rings.  It’s not supposed to be ringing.  It’s 2 am.   The voice on the other line is from an apologetic surgery resident.

Resident: There is this patient..

Me: Yes, go ahead. Please.

Resident: He’s tachycardic.

Me: How fast?

Resident: 160 ?

Me: What’s the blood pressure?

Resident: 130/90

Me: Rhythm?

Resident: An SVT I think.. I gave adenosine.  Nothing happened

Me: Audibly groaning.  I’ll be in..

Forty five minutes later I’m at the bedside of a decidedly ill appearing man.

I want to be triumphant that his heart rate is only 145, and a quick glance at the telemetry monitor above his bed uncovers juicy p waves in a cadence that suggests this is no primary electrical arrhythmia.

Something is very wrong somewhere – the heart in this case is an innocent bystander being whipped into a frenzy to compensate for something.

At the moment the whip is a norepinephrine infusion being used to keep his blood pressure up.

I ask the nurse if the amount of norepinephrine infusing has been stable.  She replies that his dose has been slowly escalating.

Eureka! I think – the heart rate response in this case is being driven by the norepinephrine – a powerful adrenaline that acts on beta receptors and alpha receptors within the body that increase heart rate and constrict the blood vessels to raise blood pressure.  Fix the cause of the low blood pressure, come down on the norepinephrine, and perhaps the heart rate would be better.

But it turns out this particular post surgical patient doesn’t have a medical cause of low blood pressure I can find.  I cycle through cardiac ultrasounds, blood gases, steroid and volume challenges, and try inching down on the norepinephrine.

All of it is to no avail.  I’m growing more and more convinced this problem is surgical in nature. Perhaps an infarcted piece of bowel?  All I know is that the man acts like he has no peripheral vascular tone.

An interesting thing happens shortly after.  The norepinephrine drip runs out.

As one nurse runs to get another bag from the pharmacy – a quick cascade of events unfolds.

The brisk upstroke from the arterial line that marks the pressure wave generated with every beat of the heart starts to dampen.  The color seems to visibly drain from the patients face, and he begins to complain that his vision is getting blurry.  His systolic blood pressure is 70 – an almost forty point drop within a minute of the norepinephrine running out.

Continue reading…

Health in 2 Point 00 Episode 32 — Takeover Edition

It’s a #Healthin2Point00 #Takeover edition — in which I get the boot and Jessica DaMassa invites Eugene Borukhovich who runs Bayer’s Digital Health Division and oversees the #Grants4Apps program to answer all he knows about ICEE Health (the conference they’re at), startups in Romania & biotech in China in just 2 minutes — Matthew Holt

Health for coins, not dollars ;) – The “not so serious” Mapping of Healthcare Cryptocurrencies

At this years’ SXSW it was all about blockchain and cryptocurrencies, but it was like that at HIMSS, JPM, CES, etc. as well. Since we wrote already about the first of the two buzzwords – blockchain as a trend in Healthcare, we decided to tackle the idea of cryptocurrencies in healthcare. First, we checked around the office and found out that several devs have been in a couple of Telegram chat rooms as they tried to buy “health coins” in a presale (ICO – initial Coin Offering; Pre-ICO).

Will you be buying your next health plan with ethereum? Or is the new health coin going to solve the problem of fragmented healthcare records?

Continue reading…

Health in 2 Point 00, Episode 31

Jessica DaMassa asks me about PlugandPlay’s health day, people talking to bots in health care, the rumors of Softbank dropping a wad of cash on Science37, and we can’t resist some Thernos cracks. This one also has pictures! Sadly the video somehow got corrupted so it’s not your eyes, we are looking like green martians! — Matthew Holt

Can Supportiv fill the mental health peer support gap?

As promised I’m going to be featuring more interesting companies I’m working with on THCB. Supportiv, which is launching today in beta (App store/Play) is a thoroughly modern answer to the problem of scaling peer support in mental health. It’s aimed in the space between the mediation apps like Headspace & Calm, and the online therapy services like AbleTo or Lantern. The target market is anyone feeling stress or wanting support in a quick and easy format–that’s basically everyone! Using the magic of NLP, those looking for support are steered into a chatroom where a trained moderator (usually a Masters student in psychology) making sure the experience is smooth. In its trials earlier this year of the 48,000 users, 96% reported improvement. The business model? It costs 15 cents a minute, or $4.50 for 30 mins (which is roughly the expected length of a session). There’s lots of science behind the idea that peer support works but to hear more Jessica DaMasssa interviewed the co-founders Pouria Mojabi & Helena Plater-Zyberk.

Announcing the Digital Health Marketplace Summer Matchmaking Event!

SPONSORED POST

The New York City Economic Development Corporation and Catalyst @ Health 2.0 are thrilled to announce another round of Digital Health Marketplace matchmaking coming up on August 23rd! Since 2013, the Digital Health Marketplace has connected digital health “Sellers” offering technology solutions to a diverse range of healthcare “Buyers” or institutions looking for tech-enabled solutions and partnerships. At the center of the Digital Health Marketplace is the successful curation of needs and solutions that lead to the development of commercialization and the rapid adoption of new health technologies. If you are an early stage startup looking for relevant pilot/commercial partners or a healthcare organization interested in adopting leading technologies, apply for your opportunity to be matched with relevant partners for one-on-one, in-person sales meetings.

For those interested in applying, submit the matchmaking application form by July 20th, 2018 at 11:59p ET. At that time, the Digital Health Marketplace team will match Buyers and Sellers based on expressed technology needs and relevant solutions. Selected participants will join us for a series of ~15 minute sales meetings at the NYC Genome Center on August 23rd, 2018. With the ultimate goal of a mutually beneficial partnership, the event is structured to bring the most relevant pairs together based on prioritized initiatives, with the goal of facilitating follow up discussions and potential long-term partnerships.

There is no shortage of digital health solutions in today’s healthcare climate and, as a Buyer, it is often challenging to find the time and resources to sift through them all. On the Seller side, it can be difficult to connect with prestigious institutions where your technology can be most impactful; the August Digital Health Marketplace Matchmaking session aims to address both obstacles in one convenient and exciting event! We’ve seen great success over the years as the Digital Health Marketplace matchmaking events have facilitated over 900 connections between health tech Buyers and Sellers to date.

Calling all NYC health tech Buyers! Calling health tech Sellers around the world! Submit your matchmaking application! Again, the deadline to apply to the Matchmaking Event is July 20th, 2018 at 11:59p ET. The Matchmaking Event will be taking place at the New York Genome Center on August 23rd, 2018 8:30a-12:30p. If you have any questions about the matchmaking process, please email ch********@********on.com. We hope to see you in August!

Health in 2 Point 00, Episode 30

Jessica DaMassa asks me about Jonathan Bush’s exit and the future of Athenahealth, celebrity suicide and the future of mental health apps, and who Amazon/Buffet/Chase should choose to be their CEOMatthew Holt

Apple, Cerner, Microsoft, and Salesforce

… all rumored to be in the mix to acquire athenahealth.

Nope.

Why not?

a) Apple doesn’t do “verticals.” It’s that easy. Apple sells products that anyone could buy. A teacher, a doctor, my mom. Sure – they have sold high-end workstations that video editors can use, but so could a hobbyist filmmaker. Likelihood of Apple buying athenahealth? ~ .01%

b) Cerner? Nah. While (yes) they have an aging client-server ambulatory EHR that needs to be replaced by a multi-tenant SaaS product (like the one athenahealth cas built), they have too much on their plate right now with DoD and VA and the (incomplete) integration of Siemens customers. Likelihood of Cerner buying athenahealth?  ~ 1%

c) Microsoft. Like Apple, it’s uncommon for MSFT to go “vertical.” They have tried it. (Who remembers the Health Solutions Group?) But the tension between a strong product-focused company that meets the needs of many market segments, and a company that deeply understands the business problems of health (and health care) is too great. The driving force of MSFT, like Apple, is to sell infrastructure to care delivery organizations. Owning a product that competes with their key channel partners would alienate the partners – driving them to AMZN, GOOG and APPL. Likelihood of Microsoft buying athenahealth?  ~ 2%

d) Salesforce. I’d love to see this. But it’s still unlikely. athenahealth has built a product, and they (now) have defined a path to pivot the product into a platform. This is the right thing to do. Salesforce “gets” platform better than everyone (aside from, perhaps, Amazon). But Salesforce has struggled with health care. They’ve declared times in recent years that they are “in” to really disrupt health care, and with the evolution of Health Cloud, and their acquisition of MuleSoft, they have clearly made some investments here, but the EHR is not the “ERP of healthcare” as they think it is. (Salesforce’s success in other markets has been that they dovetail with – rather than replace – the ERP systems to create value and improve efficiencies.) The way that Salesforce interacts with the market is unfamiliar (and uncomfortable) to most care delivery organizations. So if Salesforce “gets” platform, and athenahealth wants to be a platform when it matures, could these two combine? It’s the most likely of the three, but I still see the cultures of the two companies (I know them both well) as very different, and not quite compatible. Likelihood of Salesforce buying athenahealth?  ~ 10%

e) IBM. yup. I forgot that one. Many recent acquisitions. This would fit. I don’t think it would work very well, but it could happen. ~6%

Others?Continue reading…

The verdict is in: All three of CMS’s “medical home” demonstrations have failed

Between September of 2016 and last month, CMS released “final evaluations” of all three of its “medical home” demonstrations. All three demos failed.

This spells bad news not just for the “patient-centered medical home” (PCMH) project, but for MACRA. The PCMH, along with the ACO and the bundled payment (BP), is one of the three main “alternative payment models” (APMs) within which doctors are supposed to be able to find shelter from the financial penalties inflicted by the MIPS (Merit-based Incentive Payment System) program which was recently declared to be unworkable by the Medicare Payment Advisory Commission. Medicare ACOs and virtually all Medicare BP programs are also failing. Thus, we may conclude what some predicted a long time ago – that neither arm of MACRA (the toxic MIPS program and the byzantine APM program) will work.

In this post I describe each of CMS’s three PCMH demos, review the findings of the final evaluations of the three demos, and then explore the reasons why all three demos failed. I’ll conclude that the most fundamental reason is that the PCMH is so poorly defined no one, including the doctors inside the PCMHs, knows what it’s supposed to do. That’s not to say that the hopes and dreams of PCMH proponents were never clear. They have always been clear. PCMH proponents have said over and over the PCMH is supposed to lower costs and improve care. But a clear expression of hopes and dreams is not the same thing as a clear description of what it is you’re dreaming about.Continue reading…

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