Author: Ann Marie Marciarille

If you haven't read N.R. Kleinfeld's article tracking Geri Taylor's five years or so with an Alzheimer's diagnosis, you should. Interestingly, the lengthy article is a separate section unto itself in my print version of the Sunday New York Times today. Why is that? Strong stuff ahead, wouldn't want anyone to stumble on it? Can this be it — in a newspaper that does not hesitate to put a photograph of a dead person in its pages?  Whatever it means, I find it quite telling that the online version of the article tells you that an automatic book marker has been set, so that you may leave the article and resume where you left off. Perhaps this is common, perhaps I've never seen this before, perhaps this is a particularly useful feature for readers with cognitive impairments, or perhaps we all know that 10,000 or so words on a slow disturbing cognitive decline may require a few breaks for breathing room, nay gasping room.

The part of the article that struck me the hardest was how little was said about the astonishing financial cost of aging in place with Alzheimer's (to self, to mate, to caregivers). The Taylors have resources, both in terms of  financial capital ("In time, they would revise their wills, shielding some assets for their children") and social capital (children and step-children abound). Many Americans do not. And though Jim Taylor seems to be as honest and kind a companion in this twist of fate that might reasonably be asked for, there is no guarantee he will not age into the cognitively impaired club himself.  

Geri Taylor decided, to her great credit, to out herself after her Alzheimer's diagnosis, despite professional advice that she not stigmatize herself in that way — even to friends.  As she made her careful, thoughtful, deliberate rounds of self-disclosure, her shock at discovering some of her friends were on the same path as well merits a pause.  

 

 

Justice in Aging has a new report out on elders and homelessness.   You don't have to read too far to realize that what presents as a housing problem is at least as much a health care problem and an income support problem.  If a low income senior needs accessible housing  from the very lowest niche in the commercial housing market and has only SSI to spend (roughly 75 percent of the federal poverty level), they are in big trouble in many American cities.

Of course, so are many others.  Matthew Desmond's Evicted: Poverty and Profit in the American City makes it clear that single mothers with younger children are widely discriminated against in the private housing market while what little there is of residual public housing has become oriented toward elders and individuals with disabilities. And the competition for lowest rent housing is so fierce that the mere presence of children (representing hard wear and tear on the rental unit as well as possible  knowing eyes of government employees there to take stock of often sub-standard housing) is enough to force many families to disband or move from eviction to eviction — living as urban nomads with none of the attendant home and school stability children crave and need.

The irony that urban rental prices are astonishingly high in the poorest neighborhoods, mostly because they can be, means that rents are paid that might buy better housing and environment elsewhere. Evicted is a clear-eyed look a the winners and losers in a housing system uninterested in housing stability for the families involved. It is, after all, in the churn that money is made.  Many evictions and encounters with the law later, I can only wonder where these single mother heads of household will live in their own years as elders. 

Paul Kalanithi's memoir, When Breath Becomes Air, is at its best when it is not trying to be particularly profound.  And I think it is, paradoxically, more moving in its earlier parts — not that the story of Paul Kalanithi's diagnosis, treatment, and eventual death at 37 from lung cancer is told in a an entirely linear fashion, for it is not — perhaps because we get real flashes of what he must have been like as a doctor in these pages. Later, we learn oh-so-much-more about him as a patient.

I was particularly struck by Paul Kalanithi's matter-of-fact remembrance of his first medical visit for rapid weight loss and "ferocious" back pain.  Hoping to see a Stanford classmate, he ends up at this visit with a practice partner of his friend, someone who is a stranger to him.  Now we see the power balance start to shift. He is more deferential than he thought he would be to her price and scarce resource-sensitive decision to start with x-rays before considering the MRI he requests. "MRIs for back pain are expensive" he notes as an aside though, because he fears cancer, he is eager to escalate. 

Afterwards, he asks "Why was I so authoritative in a surgeon's coat but so meek in a patients' gown?" This question is all the more poignant in light of the fact that he, as a neurosurgeon, knew more about back pain than this unknown internist did.

Oh, if he had only lingered there. Was it the gown, so emblematic of the power differential? The lessened deference to another doctor when the encounter is between strangers? Was it his own sense that it was unwise to escalate too quickly and, if so, was it because he shared her concerns about price-sensitivity and resource allocation or his own anxiety about confirming his worst fears?

Ultimately, Paul Kalanithi receives his diagnosis and, as prognosis weakens, struggles with being patient and letting someone else (by now an oncologist) be doctor.

He went on to continue his neurosurgery practice for a while, after this first internist encounter and even later, and I have to wonder if it changed him as a provider, as it surely changed him as a person.

Yesterday, the FTC filed a complaint against Endo Pharmaceuticals and others for the use of pay-for-delay settlements to keep generic versions of certain drugs off the market.  Sometimes called reverse payment deals or pay-to-go-away settlements, these agreements resolve patent disputes by essentially paying the generic drug maker to not only stop litigating but to commit to a delay in bringing a generic entrant to market.  The "no-AG commitment" wrinkle, reported to be included in about half of all pay-for-delay deals, is when a potential generic entrant bargains for exclusivity when generic entry does occur (when the first generic entrant does not have to compete against any product other than generics placed in the market by the branded drug producer) — this time the exclusivity is guaranteed by the branded maker agreeing not to market a generic version of its own drug.  

The "no-AG commitment" agreements are interesting because, in tandem with a pay-for-delay settlement, they can be seen as designing a system of brokered exclusivity in the market on a sequential basis, without having to implicate the exchange of cash or compensation, often a trigger for antitrust scrutiny and concern.  It might be seen as a form of temporal market allocation, if you will, — "First you have a monopoly, then I'll have a monopoly, etc. We'll take turns!"

There is case law indicating that these kinds of deals may be considered reverse payments and anti-competitive. It will be interesting to see the FTC attempt to expand Actavis in this way.

But what really caught my eye was the name of the lead opioid restricted from generic competition in the market: Opana ER. The lidocaine patch Lidoderm is also involved. But the newly announced litigation on behalf of America's Opana ER consuming public should make us think hard about Opana ER's place in the opioid marketplace.  

Opana (Oxymorphone), of course, is twice as strong as OxyContin, with a powerful sedative effect.  One theory for Opana's wild rise in popularity for recreational drug use is to view it as a work around for hard-to-defeat reformulated OxyContin.  Popularly known as "stop signs" or "the O bomb" or "the new blues" — Opana abuse is the scourge of rural communities, surpassing meth in many places. Interestingly, a number of deaths previously ascribed to heroin abuse may actually be heroin and Opana abuse. We find this out, of course, only when detailed post-mortem blood work is done, with surprising results.  As an injectable drug – cooked to defeat the extended release coating and then injected — Opana abuse has also become a marker for the spread of HIV in some communities. One measure of the spread of the injectable drug abuse epidemic is the measure of new HIV cases. The development of new HIV cases apparently related to injectable drug abuse is staggering in places like Indiana.

Opana ER has its legitimate uses, of course, for round-the-clock treatment of moderate to severe pain. But I have to wonder how much of its current supply for prescription use ends up in pharmaceutical drug diversion and why so few are talking about that.

 

There's a great deal to be learned from the recent price hikes on Seconal Sodium (a/k/a Seconal) — some of it very difficult to think about.  The fact is that Seconal is widely prescribed for physician assisted suicide, at least in the states where this practice is legal and reported.  Seconal began life in the 1930's and quickly earned its reputation as a dangerous drug.  Over time, it came off of patent and interest in its production declined. Seconal is back in the news because of very recent price increases by the firm with current rights to sell Seconal. Valeant Pharmaceuticals holds these rights now.   

A lethal does of Seconal has reportedly gone from $200 in 2009 to about $3000 dollars today, so this is not exclusively a Valeant-driven run up in price.  In fact, Valeant is just the latest of a series of owners of the right to sell (but not, necessarily, to produce) Seconal, though Valeant's recent doubling of the retail price has caused significant comment.  Now, Valeant has its own troubles (as does Philidor Rx Services, a pharmacy until very recently closely association with Valeant).  It is a firm built on a seek the undervalued product, buy it low, raise the price, and then move on strategy. Mike Pearson, Valeant CEO until about a week ago, was historically unapologetic about this business model, saying: [If ]“products are sort of mispriced and there’s an opportunity, we will act appropriately in terms of doing what I assume our shareholders would like us to do.” 

There's the rub, particularly for a prescription drug widely used for physician assisted suicide. What does it mean for a sole source generic drug to be "sort of mispriced?'  Pharmaceutical pricing can be and is based on a dizzying array of models. Valeant's refreshingly and startlingly clear adoption of market based pricing has shocked some not ordinarily exposed to the vagaries of pharmaceutical pricing but has shocked few within prescription drug land.  This is the Valeant business model, after all, and Valeant has been the darling of Wall Street for some time for it.

Now, maybe it was genius to anticipate the spike in demand for Seconal once California's Physician-Assisted Suicide law was passed (though, through an interesting drafting provision, it will not take effect until  June 9,  2016). Or, was it hubris, given that the numbers of those actually using physician-assisted suicide where it is legal and where it is studied are not large, though  the trend line does show a steady increase?  Or, was it both?  Is what we are seeing a calculated gamble that California's new acceptance of physician-assisted suicide will spark a surge of both interest and use?  Will it tip any number of other states into legalizing the practice?

It is worth noting that the value of a prescription for a potentially life-ending dose of Seconal is not in its use but, for the overwhelming majority of those seeking these prescriptions, in its potential as a back up plan.  Seen from this perspective, Valeant's profits are extracted as the price of a health care system where so many can imagine a medical fate worse than death.

Whichever trend line develops, Valeant would have needed to make their money fast as significant increase in demand might well entice a generic manufacturer into the market.  So, some growth but not wild growth might allow for maximum profit until it became time to abandon the drug and move on to the new cool thing.

But Valeant may have miscalculated the visceral public reaction on this one. Even though California law allows insurers to decide whether or not to cover the physician-assisted suicide drugs at will, a majority appear poised to do so. Medi-Cal will also cover these prescriptions. So, it will be a relatively small number of Californians exposed fully to these remarkable drug price increases unless, of course, steep price increases would lead to the placement of the drug on the top (high copay) tier of prescription drug coverage. Time will tell.

Veterinary Nembutol is, of course, much more modestly priced.

 

 

 

It got kind of confusing for a while there with all the interchangeable monikers WalMart kept using for their relatively new small format stores: Express Stores, Neighborhood Markets, and not Super Centers. Here's what you really need to know: WalMart's much vaunted distribution and pricing genius stumbled and eventually failed in the small format stores it created for rural communities where the Dollar Store was king.  Oh, and re-naming the Express Stores, Neighborhood Markets did absolutely nothing to halt the debacle.  What ever you call them, WalMart stores with considerably less than 30,000 square feet had difficulty interoperating with WalMart's  Supercenter-focused acquisition and distribution systems.  Ever nimble, WalMart is closing its Express Stores, and some of its Neighborhood Markets with  almost of the closing facilities found in rural communities where retail choice may never have been large to begin with. 

What's all this got to do with a parallel story of small hospital closures also spreading across rural mid-America and the South? Some parts of the story will sound familiar: in acute care, scale matters as well. The very smallest most isolated rural hospitals are often propped up with Critical Access funds, however, so here the stories begin to diverge.  The mid-sized rural hospitals were supposed to find new lifeblood in an infusion of ACA expansion Medicaid dollars. With the now optional Medicaid expansion, that isn't happening everywhere. So, vulnerable rural mid-size hospitals are beginning to close, often under staggering unreimbursed care debt.  Many of these hospitals were troubled before the Medicaid expansion was optionalized, however, for the same reason those Express Store WalMarts struggled.  There is a price attached to the increased push for standardization in medicine and the rewards are to the technologically nimble, whether it is quality and performance data that must be quickly and efficiently gathered or hospital equipment and procedural expertise that must be accumulated.

I have been wanting to map WalMart closures on rural hospital closures in some kind of amazing "scale matters" and so does Medicaid expansion map. I just need to figure out how to map this onto this.  Of course, these two parallel tales may serve to undermine the happy narrative that rural hospital closures will be off-set by an increased number of  WalMart in-store care clinics in low income rural communities.  

Olympus Corp. of the Americas (OCA) controls roughly three-quarters of the $23.8 billion North American endoscope market.  An endoscope is a medical device with a light at the end used to look inside a body cavity or organ. Now, maybe I should say that again: OCA controls roughly three-quarters of the $23.8 billion North American endoscope market. And, yet, OCA apparently still found it necessary to build or maintain market share in the North American endoscope market by paying physicians and hospitals kickbacks in the form of consulting payments, foreign travel, lavish meals, high dollar grants, and free endoscopes between 2006 and 2011. Endoscopes are lucrative, $600 million in kickback induced sales during this period producing $230 million in profit in the U.S. alone. 

The scale of the recently announced three year deferred prosecution agreement (DPA) between Olympus and DOJ is remarkable in itself but what really caught my eye was the claim that it was OCA's failure to develop appropriate compliance programs (training, staffing, appointing an experienced professional compliance officer) until well into the offense period that singled it out. And so because it was, at least in part, an organizational wrong, a corporate integrity agreement is part of the solution requiring, among other things, that OCA adopt an executive recoupment program requiring that executives engaging in misconduct forfeit up to three years of performance pay.  All of this begs the question of why only three years of performance pay? And why were no medical centers or doctors named in the complaint — a complaint replete with remarkable accounts of lavish overseas travel producing OCA product zealots with apparent success in influencing selection and sales of endoscopes at prominent large medical centers?

It has not been a good year for OCA endoscopes, particularly with regard to those used for colonoscopies. The problems with designing and manufacturing a scope that will not serve as a disease transmitter are now well known to OCA.  But I can't help but wonder about the intersection of these two trajectories.  Is there any evidence that, as disease and infection transmission data built up on scope problems apparently related to OCA scopes (as well as, to a different degree, other brands) that individual practitioners or medical centers were reluctant to either engage in searching root cause analysis or to discontinue use of the OCA scopes pending root cause analysis because, in whole of in part,  of the extremely lucrative compensated referral arrangements or kickback agreements in place?

Inquiring minds would like to know. 

I have been participating, as a subject matter expert, in a little bit of the brainstorming and project-generating phases of a Code for KC health care oriented effort designed to generate one or two volunteer coding projects that will be initiated in June, completed by the end of the year, and hope to benefit a health care improvement stakeholder in its work.  

What an amazing experience it has been to listen to the pitches, participate in brainstorms, and marvel over the sorry state of much health care (meaning both clinical health and public health) data. I find the premise that those with the tech skills need to collaborate with those with the subject matter skills in order to produce a project and a deliverable that will actually be useful and be used by an entity that promotes health compelling.  I have learned about some amazing projects in the greater Kansas City area, often operating on a shoe-string budget, designed to improve health care access and health in astonishingly creative ways.

I cannot forget some of what I have heard discussed: Might Serious Mental Illness (SMI) screening kiosks work for homeless or transient populations?  Are organized churches in the African-American community good sites for congregate health education on nutrition and self-care for those with Type II Diabetes or pre-Type II Diabetes?  How can low income individuals learn about and learn to use community-based access to health care transportation resources?  Can we use diagnostic "hot spot" mapping to learn more about the social determinants of health — say, for example, the relationship between Emergency Department pediatric asthma attack visits and the prevalence of sub-standard housing?

Many jurisdictions, state,county, municipal, and even neighborhood, keep far more data than is commonly available in Kansas City on disease incidence and diagnosis.  The way I see it, the real grand challenge for Code for KC: Health Care Projects is to explain why we have so little health care data, why it is so poorly organized, and how we hope to improve anything if we measure so little?

Code for KC's Health Interest Group meets Monday evenings at the Sprint Accelerator,from 6-8PM, if you are also haunted by these questions.

I suppose it was inevitable that as the Downton Abbey series slowed after six seasons, more script time would be spent documenting the social changes swirling around the Crawley Family.  Inevitably, an inter-generational power struggle story over leadership of the local cottage hospital as it struggled with modernization caught my eye.  It isn't every day that you see a hospital merger story featured in popular culture.

What was at stake was the difficult decision of the local cottage hospital on whether to continue as a small independent charitably funded entity or to join forces with the larger government funded hospital, embracing a more distant (literally and figuratively) form of health care for the village as a tradeoff for access to more modern equipment and services.  Interestingly, this sub-plot has been seen as a commentary on American health care reform when, oddly enough, it is a reasonably accurate rendition of Britain's own struggles over hospital identity and health care reform in the early 20th century.

The cottage hospital movement arose in the 19th century as an alternative to large impersonal poor farm and work house-derived acute care facilities for the poor and indigent. Small, intimate,  and geographically proximate to the community: the cottage hospital movement symbolized an agricultural laborer or working person's acute care alternative to the large county hospital.   In Britain, these were known as voluntary hospitals and they comprised a significant percentage of acute care facilities at the turn of the last century.   By the early 20th century, we are witnessing the rise of the government hospital in the series as in history as we chart the decline of the landed gentry who funded voluntary hospitals. The rest, as they say, is history.

The interesting thing is that the cottage hospital movement also took hold, on a smaller scale, in some parts of the United States. Though more often called community hospitals in the United States (meaning hospitals that are independent, free-standing of hospital chains, and not part of academic medical centers), small cottage hospitals were not uncommon in rural areas until well into the 20th century. Cottage hospitals, or community hospitals, in the United States struggle with the same issues: the advantages of community based care traded off against the limited resources available to bring the most modern services and innovations to the local level.

Where does it end in Downton Abbey?  In the Season Six Finale, we see Lady Grantham masterfully chairing a community town hall meeting where she managed to, simultaneously, re-assure the local populace that no providers would be lost in the transition to government hospital  and clinic care while emphasizing the noblesse oblige redolent of the voluntary hospital would  also not be lost by any diminishment of Lady Grantham's interest in the soon to be merged-into-one government hospital entity.  But it may be the Dowager Countess, her tart tongued mother-in-law deposed from her power on the local hospital board, who saw it most clearly when she noted that government professionals as administrators would soon have little use for Lady Grantham — she was presiding at her own demise. 

Now, Lady Grantham is American by birth, possessed of an incurable optimism and  a healthy dollop of can-do philosophy.  But even she must have sensed the sagacity of Dowager Countess's  prediction of her own obsolescence. 

Come one, come all!  And, if you can't attend in person, I'd love to know your best question for Brad on this topic. Thanks.