Specialty and Chronic Care–Re-Imagined

It’s not news that technology-enabled innovations are major drivers in the transformation of care delivery. Cutting-edge solutions are re-organizing provider workflows and delivering real-time data analytics to improve outcomes, lower costs and empower both acute and chronic care patients to be their own best advocates. What’s new is the emergence of tech-enabled services that are taking aim at specific parts of chronic disease and specialty care.
At this year’s Health 2.0 11th Annual Fall Conference, we will provide a lively and in-depth exploration of these new market entrants in the realms of diabetes and oncology. The Evolution of Care Delivery Panel will include Livongo, Canary Health, Omada Health, Virta Health, MySugr, Integra Connect and Flatiron Health, all very well funded and all doing things very differently than the status quo.
How far will these new technologies change the organization of care delivery, and what are the impacts for patients, clinicians, providers, payers, pharma and vendors? Register here for the Annual Fall Conference  to find out!

P.S. Get a sneak peek of the key topics and discussion points of the panel session during the upcoming The New World of Specialty Care Webinar on Wednesday, August 15Register here for the free webinar.

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Cucumber Melon Ginger Punch (Large Batch)

Looking for a large-batch cocktail recipe? Make this delicious Cucumber Melon Ginger Punch recipe made with fresh honeydew, cucumber, organic vodka, and ginger beer! One of the best parts about my job is supporting local. So many of Fit Foodie Finds’ clients are based here in Minneapolis/St. Paul and it just makes me so happy to…

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Cucumber Melon Ginger Punch (Large Batch) syndicated from http://ift.tt/2liIz0K

Doctors Do Know Best. Exhibit A: The Charlie Gard Case.

For American conservatives, Britain’s NHS is an antiquated Orwellian dystopia. For Brits, even those who don’t love the NHS, American conservatives are better suited to spaghetti westerns, such as Fistful of Dollars, than reality.

The twain is unlikely to meet after the recent press surrounding Charlie Gard the infant, now deceased, with a rare, fatal mitochondrial disorder in which mitochondrial DNA is depleted – mitochondrial depletion disorder (MDD). In this condition, the cells lose their power supply and tissues, notably in the brain, die progressively and rapidly.

The courts forbade Charlie’s parents from taking him for a last dash of hope to the United States. This confirmed for many conservatives the perils of a government-run healthcare system, where the state decides who lives and who dies through Death Panels.

Ted and Mike, whose healthcare reform might affect many curable little Charlies, were moved by the plight of an incurable Charlie. No European will understand the science behind their sentiment – if you care so much about a sick incurable baby, why don’t you care about sick, cure.

Brits will never get the importance conservatives place on individual choice, even if that choice is forlorn, and of the lure of medical heroism. Conservatives seldom acknowledge that modern medicine reaches its limitations too quickly for Death Panels to be effective. Charlie was given a grim prognosis by doctors at the Great Ormond Street Hospital (GOSH), arguably the finest hospital for sick children in the world.able babies, they’d ask.

GOSH might not have the endowments of its American counterparts. It is an orthodox British hospital with creaking staircases, the sort where I trained, where doctors have incredible clinical acumen, paranormal common sense, and dabble freely in paternalism. Doctors know best and are not ashamed to say so. When doctors at GOSH say death is imminent, Death Panelists are rendered unemployed, unless there’s a miracle to slay. For Charlie, that miracle was a New York neurologist offering an untested therapy.

The reaction to Charlie’s plight is as instructive as the reaction to the reaction to his plight. It’s as if everyone took the Rorschach test simultaneously.

Charlie’s plight was felt by the Pope. The Pontiff is a busy chap and can’t possibly Tweet in support of every dying child in GOSH. But once the media portrayed his suffering, everyone jumped on the bandwagon. The Pope was joined by Ted Cruz, Donald Trump, Theresa May, Nigel Farage and even the notoriously unsentimental Jeremy Corbyn. This is the power of the identifiable victim.

Some have wondered whether our preoccupation with stories such as Charlie’s diverts our moral and financial resources from tackling deaths from malaria in Africa – i.e. we don’t care about deaths from malaria because we care too much about one dying infant. In this classic utilitarian fallacy, the utilitarian treats moral sentiments as a zero-sum game with opportunity costs. The truth, as Adam Smith pointed out in Theory of Moral Sentiments, is that we’ll always be more perturbed by events proximate to us, the identifiable victim, than random people who don’t appear on our Twitter timeline. If Charlie hadn’t surfaced in our news channels, we still wouldn’t be fretting about deaths from malaria in far off countries we’ve never heard about.

Charlie’s case showed the limitations of not just modern medicine but modern medical ethics.

When all hopes seemed lost, Charlie’s parents did what many do today – they consulted Dr. Google, who didn’t disappoint. Their search revealed a New York neurologist – Dr. Michio Hirano, a researcher and an expert in mitochondrial disorders.

When hope resurfaced so did the controversy. The first point of controversy was that the nucleoside therapy Dr. Hirano was offering was not scientific – i.e. there was no proven benefit of the nucleoside in the specific variant (RRM2B) of Charlie’s MDD – it hadn’t even been tested on animals with that variant. GOSH, the High Court and the terribly unoriginal European Court, used the absence of proven efficacy in their justification for stopping the parents from taking the child to the US.

“Not scientific”, a compelling statement as no one can argue with science, needs parsing. It is possible for a treatment for a rare disease to have promising results in a small trial in the US, but still not be available in the NHS either because the National Institute of Clinical Excellence (NICE) hasn’t gotten around to approving it or is waiting for more evidence. This wasn’t the case with Charlie’s disorder, but my point is what may be unscientific today may truly be unscientific or may simply be waiting for NICE to schedule a conference call.

Charlie would have been the first patient with the RRM2B variant to have received the nucleoside therapy. Though we don’t know for certain, it is highly unlikely Charlie would have responded favorably. Had he responded favorably, the treatment’s efficacy would be certain. This is because Charlie’s condition had a 100 % fatality and anything that’d have saved him, gotten him off the ventilator and breathing spontaneously, and restored his motor function, would either be a parachute or a prophet – you don’t need a double blind, placebo-controlled, randomized controlled trial to test the efficacy of a drug for a condition which is imminently and uniformly fatal.

The neurologist was accused of having financially conflict of interest in nucleoside therapy, which he has strongly denied.

This familiar moral dilemma, which brings science closer to morality than necessary, begs legitimate questions. Was the doctor genuinely motivated by a desire to help or by making more money? Was there truly therapeutic equipoise or was he selling snake oil?

Science being morally neutral means that the neurologist’s motivation for helping was moot. The therapy either worked or didn’t. And if it worked no one would care if the doctor is Satan. If it didn’t work it scant mattered if he were the Pontiff. His financial conflict of interest is relevant only because it indicates whether equipoise – i.e. that the therapy may work –  is justified.

To emphasize, we must believe that science, i.e. proven treatment benefits, is morally neutral –  because it would be silly not to – I mean it’d be like saying a treatment would work better if the prescribing doctor were more pious.

But, seemingly, equipoise is not morally neutral. What we’re saying is that the uncertainty, and I repeat the uncertainty, that a treatment may work depends, to some extent, on the motivations of who is calling the experiment. This is understandable because medicine is replete with stories of sellers of snake oil. But there’s a large coastline of plausibility far removed from snake oil.

Dr. Hirano wasn’t selling snake oil. He was selling a plausible but untested treatment to desperate parents. The nucleoside therapy had modest efficacy in a variant of Charlie’s disorder (TK 2). But had never been tested in the RR2MB mutation, which Charlie had. It was unscientific because it was unproven – it wasn’t implausible – it certainly wasn’t snake oil.

Ironically, precision medicine exposed the unscientific nature of the nucleoside therapy. Imagine if you couldn’t sequence. You wouldn’t know that MDD had variants – that is you wouldn’t know whether Charlie’s MDD was the TK2 or the RR2MB variant, it’d all be the same. Would the nucleoside therapy, which had worked in a handful of patients with the TK2 variant, still have been unscientific? This is not a dig against precision medicine. I’m merely asking for less dogmatism in what we call unscientific, given that the line is so thin between groups in which therapies work and don’t work.

This takes me to the desperation of Charlie’s parents. I can’t even begin to imagine what they were going through. I recall how I reacted at the very slight possibility that my older son, when he was three weeks old, had pyloric stenosis. My frontal lobe stopped working. Were I Charlie’s parents, I’d have fought tooth and nail and eked every possibility. I’d have done exactly what they did.

Parents of children who have terminal illnesses have nothing to lose, so they pursue any hope, no matter how hopeless the hope is. Some ethicists find this sentiment repugnant. You can see why the ethicist’s ire is drawn. Picture this – desperate parents willing to do anything, offered false hope by a doctor who knows that their condition is hopeless, who knows the treatment is unproven, and who is merely taking advantage of their predicament, like a parasite. Won’t you be disgusted by that doctor?

Let’s reframe this. A doctor offers hope to desperate parents who have nothing to lose except hope itself. The doctor believes that denying hope, no matter how hopeless, will be crueler than giving hope. Incidentally, Lord Krishna, one of the many Gods of Hindus, said that a lie which makes someone feel better is better than a thousand truths which make a person feel worse.

Are you still disgusted with the doctor prescribing hope? I’d say “repugnance” is a rather strong sentiment in this ethical gray zone, where the answer depends on how the situation is framed. To believe medical ethics is as absolute as Newton’s Third Law of Motion betrays an alarming level of judgment.

Charlie would have been the first to receive the nucleoside therapy for his condition. In any trial of medical treatment, there is always an index patient – the first to receive the unproven therapy. This is an inviolable fact, whether the unproven therapy later proves itself or not.

Would we be offended if Charlie was the first to receive the unproven treatment as part of a research trial with a hypothesis where the researcher purposefully set out to collect data and specified the outcomes in advance?

It was unethical to experiment unproven therapy with Charlie. Paradoxically, it was also unethical to give Charlie unproven treatment because it wasn’t an experiment.

What then in modern era is the difference between a neurologist responding to desperate parents by giving unproven therapy and a neurologist responding to desperate parents by giving unproven therapy as part of a trial? It’s easy seeing that both scenarios are experimental. But there is a difference. The latter comes with regulatory oversight, the former doesn’t. So, a major gripe here is the absence of regulatory oversight.

This wouldn’t have been the first-time unproven therapy has been offered to sick children with fatal conditions short circuiting a trial. Take the case of surgery for complex congenital heart diseases such as Hypoplastic Left Heart Syndrome. The first time a surgeon operated on a neonate with this condition, the treatment was unproven and, therefore, unscientific. The treatment was offered to desperate parents who believed they had nothing to lose. Indeed, the operative morbidity and mortality for early cardiac surgery for congenital heart disease was so high that whatever short life span these babies had was curtailed by the surgery – i.e. surgery made matters worse. Then the heart surgeons learnt from their errors, improved their technique and patients lived longer. Today, patients with complex congenital heart disease are old enough to worry about cancer and dementia.

Again, the ethics of offering an unproven treatment to a sick child of desperate parents is trickier than first appears. While it may make us balk, the first few recipients of unproven therapy can be made worse, even if the therapy later does net good. I’m not terribly fond of utilitarian reasoning – greatest good to the greatest number – but utilitarianism makes its way through multiple avenues. One argument, which I’m partial to, is that if you relax the access to therapies which haven’t been adequately scientifically vetted for rare diseases with no cures, drug developers will have little incentive to produce genuine cures. This is a compelling and highly plausible conjecture, but it is utilitarian at its core – i.e. we believe that easy access for a few could lead to net harms for many.

Some have defended the action of GOSH by saying it is not about costs, only effectiveness. This is understandable – no one wants to muddy the issue by talking about costs – but disingenuous. Of course, costs are important when the taxpayer is footing the bill. Charlie was ventilated. He’d have to be shifted by air ambulance and accompanied by trained personnel. Medical resources aren’t free even in the NHS. And given that the effectiveness of the nucleoside therapy is nearly zero, the cost-effectiveness would be nearly infinite.

Charlie’s parents had raised funds to help with the costs. This evokes a familiar sentiment in the NHS – should they be allowed to pursue treatment simply because they can afford it? The NHS prides itself, rightly so, on equity – no one is denied proven treatment because of inability to pay. But it’s hard seeing how equity is disrupted if someone decides to pay for futile treatment. Furthermore, Britain has a parallel private system in which proven treatment is accelerated for those who can pay. The Brits, when they want, seem perfectly capable of tolerating inequity.

The crux of the matter was the tension between the welfare of the child and the wishes of the parents. When I was a junior doctor working in an emergency department in London, we were counselled not to bow to the demands of parents and prescribe antibiotics for febrile children. Doctors, even junior doctors, knew best.

The trickier situation is when parents refuse treatment for their sick child. Doctors have the law on their side here and you can understand why. If parents of a child with meningococcal septicemia are conscientious objectors of synthetic therapy and decide that antibiotics for meningitis aren’t indicated, their wishes can’t supersede medical necessity. That is if parents clash with doctors, the doctors will prevail, and the child will receive life-saving antibiotics against the wishes of the parents, and rightly so. Let me state this in no uncertain terms – the courts agree that doctors know best.

Neither medical paternalism, nor the fight against it, is absolute. Doctors do know best, but “best” is a spectrum. For example, the courts can’t force a child to be vaccinated against the wishes of the parents. Few would dispute that vaccinations are beneficial to both the individual and society. But the courts distinguish between a proximate harm and a probabilistic harm to the child.

Would subjecting Charlie to unproven therapy worsen his welfare? Arguably, yes – there’s a fate worse than death, and being on a ventilator prolonging death senselessly is a form of suffering, no less because it can’t be articulated. Does this come under the antibiotics – meningitis domain (proximate harm) or the vaccination domain (probabilistic harm)? I’d be inclined to put it towards the former, unless I was Charlie’s parents. But you can see that this, too, is in the ethical gray zone.

There’s no doubt that the doctors in GOSH made a good clinical call. But every now and then the medical profession encounters an outlier and responding to an outlier needs more than clinical acumen.

The matter reached the European Court – an institution which excels itself at irrelevance by saying nothing new. It’s hard not concluding that a drama was made of a crisis in a tricky realm where each actor wanted to stamp their absolutism. Would it really have been the world’s greatest travesty if Charlie had been taken to the US to receive an unproven therapy? Could GOSH have handled the matter more prudently? Was a legal injunction really necessary? Could the NHS have avoided been morally scolded by Ted Cruz?

Of note, when Dr. Hirano examined Charlie at GOSH he concluded that the brain damage could not be reversed. Perhaps if the doctors at GOSH had incorporated Dr. Hirano as part of their multidisciplinary team at the outset, thus respecting the parent’s preferences, the legal drama could have been avoided. NHS hospitals have something to learn from their American counterparts.

For conservatives, the Charlie Gard story affirms that the NHS is a tyrannical apparatus which conspires to rob people of their fundamental human rights and that Brits submit meekly to medical paternalism. In this tragic story, no one has been more naively absolutist than the conservatives. Calling the NHS “tyrannical” when it saves many poor kids without bankrupting their parents is absurd. This noble institution could, however, do with better PR, because it has come across as inflexible and dogmatic instead of compassionate and scientific. For both the National Health Service and the Great Ormond Street Hospital, this is a huge travesty.

Saurabh Jha is a contributing editor to THCB.

 

 

 

 

 

 

Doctors Do Know Best. Exhibit A: The Charlie Gard Case. published first on http://ift.tt/2rKD0bD


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Single-Payer is the American Way

As is customary for every administration in recent history, the Trump administration chose to impale itself on the national spear known as health care in America. The consequences so far are precisely as I expected, but one intriguing phenomenon is surprisingly beginning to emerge. People are starting to talk about single-payer. People who are not avowed socialists, people who benefit handsomely from the health care status quo seem to feel a need to address this four hundred pound gorilla, sitting patiently in a corner of our health care situation room. Why?

The all too public spectacle of a Republican party at war with itself over repealing and replacing Obamacare is teaching us one certain thing. There are no good solutions to health care within the acceptable realm of incremental, compromise driven, modern American solutions to everything, solutions that have been crippling the country and its people since the mid-seventies, which is when America lost its mojo. To fix health care, we have to go back to times when America was truly great, times when the wealthy Roosevelts of New York lived in the White House, times when graduating from Harvard or Yale were not cookie cutter prerequisites to becoming President, times when the President of the United States conducted meetings while sitting on the toilet with the door open and nobody cared. Rings a bell?

Single-payer health care is one such bold solution. Listening to the back and forth banter on social media, one may be tempted to disagree. We don’t have enough money for single-payer. Both Vermont and California tried and quit because of astronomic costs. Hundreds of thousands of people working for insurance companies will become unemployed. Hospitals will close. Entire towns will be wiped out. Doctors will become lazy inefficient government employees and you’ll have to wait months before seeing a doctor. And of course, there will be formal and informal death panels. Did I miss anything? I’m pretty sure I did, so let’s enumerate.

Single-payer is going to bankrupt the nation

We have $3 Trillion in our health care pot right now. We have 325 million Americans, men women and children of all ages. First grade arithmetic says we have almost $10,000 per year to spend on each American, the vast majority of whom is either young or healthy or both. For comparison, Medicare spends on average around $12,000 per year for the oldest and sickest population. Last year a platinum plan for a 21 year old cost less than $5,000 per year and this includes the built in waste of private health insurance. So please, tell me again how we can’t afford to pay for everybody’s health care needs at a Medicare actuarial level, which is slightly less than commercial platinum.

And no, we need not increase taxes either. You keep paying what you’re paying. Your employer keeps paying what it is paying. The government keeps paying what it’s paying. But instead of dispersing all that cash to all sorts of corporate entities standing in line with their golden little soup bowls ready to catch the last drop, we put it all together in one big beautiful barrel, and pay for care directly to those who provide care – one pool, one budget, and one accounting system for all. This is a national endeavor. It is irrelevant that Vermont failed and California bungled the whole thing. Do you think California and Vermont could afford to provide for their own armies, air force and navies? I didn’t think so.

Single-payer will cause millions to lose their jobs

Hundreds of thousands of people work for commercial insurers. Claims need to be processed, money needs to be collected and paid out, books need to be kept, customers and service providers need to be supported, computers have to be maintained, audits need to be performed, contracts need t be managed, lots and lots of labor and lots and lots of decently paying jobs. Do you have any idea how Medicare administration works? Or are you under the impression that Medicare runs itself with no human labor? Have you ever heard of Noridian or Cahaba? No? Then I respectfully suggest that you should refrain from opining about the horrors of single-payer.

Medicare is run by private administrative contractors called MACs, each assigned to specific geographical regions and specific portions of Medicare services. In addition to the MACs there are slews of functional contractors that specialize in one or more types of supporting services to the MACs. These are private entities no different from Boeing, Lockheed Martin, Hewlett-Packard, Booz Allen Hamilton, GE and many more. They employ thousands of people and if Medicare becomes our single-payer, there will be more MACs, more functional contractors, and hundreds of thousands more private employees.

That said, it stands to reason that consolidation from many payers to one, will introduce some efficiencies and the total number of available jobs will be reduced, so here is a solution to this potential problem. Currently all insurers including Medicare and Medicaid are offshoring claim processing and in the case of private insurers other functions, including clinical, as well. Change the regulations and bring those jobs back home where they belong in the first place, and offer them to those who will lose their commercial insurance jobs. This administration is especially well positioned to effect such changes to CMS regulations.

Single-payer will take away our freedom

What if Sam’s Club only carried General Mills cereal and Costco only carried Kellogg’s?  What if you had a Costco membership but stopped by another store to pick up some Cheerios and were charged ten times as much as Sam’s Cub sells it for? No it’s not exactly the same, but you get the idea. Would you consider this to be freedom of choice? Or would you rather have one big huge market where all brands sell their products directly to you competing against each other? The latter is how single-payer could work. Freedom to shop for an insurance plan is freedom to shop for your preferred rationing scheme and ultimately your own flavor of death panel.

Traditional Medicare allows you to choose your doctor and your hospital and it pays for all medically necessary services. No commercial plan can say the same unless it’s one of those platinum things nobody can afford. Traditional Medicare can do that because it sets the prices for all health care providers, instead of negotiating with a few preferred vendors. Medicare can take these liberties because it’s big enough and because it’s a Federal program. But Medicare doesn’t pay for everything. That’s why most seniors purchase supplemental plans if they can afford them, and if they are poor enough, Medicaid kicks in as the secondary payer. Being the safety net for the fixed price single-payer should be the sole function of a new and federally administered Medicaid.

Single-payer will destroy our health care

I think American medicine is the best in the whole world. Not because it’s expensive and not due to the corrupt ways in which it’s being financed, but in spite of these things. Finding a better way to pay our medical bills has nothing to do with the quality of American medicine. The concern here is that once Medicare becomes the only game in town, it will unilaterally cut its fee schedules and all hospitals will go bankrupt, all doctors will be driven into homelessness, no new drugs will be developed and we’re all going to die. On the other hand, the Federal government is the sole purchaser of aircraft carriers, stealth bombers, and weaponry of all types. How cheap are those items?  How powerless and decrepit is that industry?

Precisely because of the lessons learned from the mighty military industrial complex, single-payer reform will have to change three things in the structure of our current so-called health care system. First, all hospital consolidation and acquisition of physician practices will need to be rolled back. Second, petty regulations, vindictive carrots and sticks strategies and crude attempts at social engineering by clueless bureaucrats, will have to be dismantled brick by brick. Third, physicians will need to form a union of independent small contractors to negotiate fees and terms alongside the already powerful hospital associations. I have been a longtime proponent of a physicians’ union, even in our current system, to serve as check and balance to corporate greed and government arrogance. A single-payer system cannot and will not succeed without unionized independent physicians.

Single-payer is not the American way

We have been conditioned by large corporations to think that what they do to us is the nature of free-markets, and thus the only way to achieve prosperity for all. I would submit (for the millionth time) that what Apple is doing to the world has nothing to do with Adam Smith’s free markets. The actors in classic free markets must be approximately equal. When sellers are so big that they need artificially intelligent tools to even notice the existence of buyers, there is no free market. When the price of products sold exceeds the lifetime incomes of most buyers, there is no free market. When no one can muster enough moral turpitude to publicly say that if you’re poor, your babies should die, there is no free market. There is no free market and there can be no free market in health care.

There can however be competition. Perhaps not in sparsely populated areas, and perhaps not for highly complex procedures, but there can be competition for most health care services in most places. The uniform single-payer price should be set so that innovative hospitals and entrepreneurial physicians can thrive by charging less and those holding themselves in higher than usual esteem, or those who choose to provide luxury, are free to charge more. If all sellers are small enough, and if the standard single-payer price is fairly negotiated, we will have a real market, because people will shop to save money (in a rewards system like credit cards have) and some will shop for status and vanity.

Will there be a role for private insurance?  There could be, but private insurance should not be allowed to cover any services covered by the single-payer because that would take us back to where we are today. Let private insurance cover stuff nobody needs, but wealthy people like to flaunt, like fresh baked brioche for breakfast after having a baby, or executive physicals in palatial settings, and let those things become frightfully expensive, as these types of things usually are in a free market.

Single-payer will create a new set of losers. Health care executives making tens of millions of dollars every year for no particular reason will be losers. Perhaps they can find new careers at Boeing or Lockheed Martin seeing how their expertise is easily transferable. Health insurance stocks will tank and improperly managed pension funds will also lose bigly. People running for elections will see a major cash cow go dry after the initial struggle is over and done with. There will be powerful losers and it won’t be easy.

But Obamacare has its losers too. Hard working, taxpaying middle class citizens were the designated losers of Obamacare. Some by commission and most by omission, because Obamacare made no attempt to solve the health care problems facing the vast majority of workers with employer sponsored health insurance. That bomb keeps ticking away at a steady pace. The newly empowered Republican Party has nothing to offer either, and I can’t blame them. There is nothing more we can do here. We tried everything else, and now it’s time to do the right thing. It’s the American way.

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