NEW @ THCB PRESS: Surviving Workplace Wellness. Spring 2014. Al Lewis and Vik Khanna. e-book edition. # INNOVATION: PCORI APP Challenge

As we anticipate a new year characterized by unprecedented interest in healthcare innovation, pay particular attention to the following three emerging tensions in the space.

Tension 1: Preventive Health vs Excessive Medicalization

A core tenet of medicine is that it’s better to prevent a disease (or at least catch it early) than to treat it after it has firmly taken hold.   This is the rationale for both our interest in screening exams (such as mammography) as well as the focus on risk factor reduction (e.g. treating high blood pressure and high cholesterol to prevent heart attacks).

The problem, however, is that intervention itself carries a risk, which is sometimes well-characterized (e.g. in the case of a low-dose aspirin for some patients with a history of heart disease) but more often incompletely understood.

As both Eric Topol and Nassim Taleb have argued, there’s a powerful tendency to underestimate the risk associated with interventions.  Topol, for example, has highlighted the potential risk of using statins to treat patients who have never had heart disease (i.e. primary prevention), a danger he worries may exceed the “relatively small benefit that can be derived.”  (Other cardiologists disagree – see this piece by colleague Matt Herper).

In his new book Antifragile, Taleb focuses extensively on iatrogenics, arguing “we should not take risks with near-healthy people” though he adds “we should take a lot, a lot more, with those deemed in danger.”

Both Topol and Taleb are right that we tend to underestimate iatrogenicity in general, and often fail to factor in the small but real possibility of potential harm.

At the same time, I also worry about external experts deciding categorically what sort of risk is or isn’t “worth it” for an individual patient – a particular problem in oncology, where it now seems  fashionable to declare the possibility of a few more months of life a marginal or insignificant benefit.

Even less dramatically, a treatment benefit that some might view as trivial (for hemorrhoids, say) might be life-altering for others.  For these sufferers, a theoretical risk that some (like Taleb) find prohibitive might be worth the likelihood of symptom relief.  Ideally, this decision would ultimately belong to patients, not experts asserting to act on patients’ behalf.

Tension 2: Relentless Standardization of Medicine

Every day, I feel like I’m witnessing two parallel, completely different narratives about the current and future state of medicine.  One view – which might be termed the “Cheesecake Factory” perspective – is that medicine is currently practiced in an absurdly capricious fashion; medical care is wildly and unjustifiably variable.  Instead, medicine should be standardized like other business processes, so each patient will receive the best known care for their particular condition, rather than be subject to the whims and caprices of the treating physician.

The other story I hear is that in the evolving standardization of medicine – as physician visits become more focused on EMR data entry and adherence to mandated algorithms — something vital is being lost.  From this point of view, the advice of the efficiency experts and technologists is seen as dangerously reductive, representing a naïve caricature of medicine, where patients report symptoms, receive a diagnosis, and are assigned a treatment.  The reality, say many physicians (see here, for example), is so much messier – symptoms are often vague, reasons for the visit are often complex, there is no clearly-defined “best practice,” and the problem to be solved is often so much more nuanced that “what’s wrong with my car.”

Cheesecake Factory advocates stress they aren’t seeking to remove the nuance from medicine, and instead wish only to standardize what is already known, collect data and determine best practices so that physicians can focus on the interpersonal interaction while knowing they are treating patients in context of all available data.  It’s a compelling vision.

Yet it’s hard not to worry that if medicine goes in the direction of the Cheesecake Factory, where care is administered on the cheap by customer-service technologists plugging data into an algorithm, then an ancient and noble profession will face extinction because of an inability (some might say a haughty unwillingness) to adequately contemplate and communicate its essential value proposition.

I am overwhelmed by a feeling of tragic sadness as I see the pervasive sense of dissatisfaction that has settled over medicine, leaving so many honorable, brilliant, well-intentioned doctors in a near-state of shock, asking whether this could possibly be the profession they had dreamt of all their lives, and worked so hard to enter.

On optimistic days, I am hopeful that the process improvements and advances in digital health will inspire, not dishearten, inquisitive physicians, who perhaps will appreciate the opportunity to more fully leverage information and deliver a higher level of care.

I’m also certain that if medicine does continue to become as excessively standardized and depersonalized as many fear, this will create important disruptive opportunities for entrepreneurial physicians with a different – call it old-fashioned – vision of the value of a more substantial doctor-patient relationship.

Tension 3: Industrialization of Drug Discovery

The most significant problem facing the biopharma industry today is that large biopharmas  depend upon products they have little idea how to reliably discover.  It’s a strange concept, when you think about it – and a huge challenge for the industry, since most of what large companies do very well – industrialize processes, produce products at scale – just don’t map all that well to the skills and capabilities required for discovering new drugs.

It’s not a new problem, of course, but one big pharma R&D execs continue to struggle with – and paeans to open innovation aside, it’s not clear they’ve landed upon any sort of viable solution.

Instead, large biopharma companies continue to emphasize the importance of “line-of-sight” thinking, the idea of discovering compounds with a precisely determined commercial profile in mind.

The concept of designing-to-specification makes a lot of sense in many businesses, but it’s not clear to me it works especially well for drug discovery, where the combined uncertainties of scientific discovery and a commercial landscape that can evolve significantly in the decade or more it can take to move from scientific idea to approved drug, create profound challenges for meaningful strategic planning.

Yet, large biopharma’s deep-seated need for centralized planning arguably leads to precisely the sort of false precision Taleb and I discussed in 2008, and the fragilizing strategic planning fallacy he critiques at length here and elsewhere.

Ideally, large biopharmas would be schooled by small agile upstarts, who might be willing to pursue a greater range of approaches, and consider a wider range of potential indications.

Yet, I’m not sure this is really happening – instead, big pharmas (really, the blue chip management consultants they employ) are defining the priorities, and the rest of the ecosystem is dutifully trying to respond.

Why? The answer, perhaps somewhat ironically, is that in part because of all the critiques and concerns about Big Pharma, drug development has become so intensively regulated, and so astronomically expensive, that large biopharma companies are almost the only players who can afford most full-on clinical development efforts (see this provocative discussion by Avik Roy).

The challenge, going forward, is whether progressive regulatory reform (including greater use of digital health technologies – see this encouraging example) can reverse the current trend and make drug development faster and cheaper, or will the process instead become only more burdensome, slow and expensive.  If this happens, the stodgy, fragile, central planning of research by large biopharmas will remain dominant – in spite of their strategy, not because of it.

Unless or until agile competitors can figure out a significantly faster and cheaper way to develop drugs (the successful application of a personalized medicine strategy remains attractive but largely elusive), it’s difficult to envision the current innovation climate improving very much – bad news for innovators, and worse news for patients.

David Shaywitz is co-founder of the Center for Assessment Technology and Continuous Health (CATCH) in Boston.  He is a strategist at a biopharmaceutical company in South San Francisco. You can follow him at his personal website. This post originally appeared in Forbes.

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18 Responses for “Through a Scanner Darkly: Three Health Care Trends for 2013”

  1. Whatsen Williams says:

    Humans are not cheesecakes. Now say “cheese”!

    Care must be individualized to unique features of the patient being treated.

    Computerization of care is detrimental. It is so detrimental that the HHS has issued a Christmas confessional that the HIT devices it has been promoting are not safe and must besurveiiled.

    Problem is that itsplan will not accomplish much…merely lip service.

    • BobbyG says:

      “Computerization of care is detrimental”

      Perhaps given the current deployment priorities and architectures.

      See the Weeds’ “Medicine in Denial.”

  2. Nick says:

    Hey, found this interesting website that predicts the top health care trends for the coming year. Discuss them across the anonymous community on Social Number. http://bit.ly/SdsthC

  3. legacyflyer says:

    Whatsen,

    Can you provide a link to the “HHS confessional”

  4. rbaer says:

    Dr. Shaywitz wrote (in a post he linked to from the above OP):
    “This (efforts to reduce overtetament in the terminally ill/dying) may make perfect sense in the classroom, but in the real world, it’s hard to escape the thought that these sorts of lofty efforts intended do good for People in the Future are more likely to harm the care of individual people in the present, and erode the very dignity of life that health policy at its core, should seek to defend.”

    Funny. From my own hospital experience, I get exactly the opposite impression: real suffering from overtreated (i.e. intubated, resuscitated), and usually unconscious or barely conscious dying patients, while there are some religiously or philospohically arguing individuals making lofty remarks about the sanctity of life.

  5. Curly Harrison, MD says:

    Yes, doctors treat one disease with another, oft w iatrogenesis.

    I must admit that the greatest propensities to iatrogenesis that I have seen in the past five years emanate from the CPOE and EMR devices.

    Funny that the HHS is now making a feeble attempt to address the safety of HIT. This comes after years of warnings from the likes of the Health Care Renewal Blog w Scot Silverstein, MD.

  6. bev M.D. says:

    I am impatient wtih statements like ‘computerization of care is detrimental.” Give me a break. With the amount of data contained in health care, nothing but computerization is able to handle it. As a med student in the ’70′s my job was to track down the old chart; now no one even bothers looking for it, they just ask the patient/family for the old history and accept whatever they are told, or keep re-treating the patient in the ER for the same set of symptoms without realizing this is the 8th time it has happened (as happens to my elderly mother). Keeping track of medications is completely unacceptable. All that has created more harm over the years than the current, admittedly grossly inadequate, first generation attempts to ‘computerize’. Instead of complaining about it, agitate to make it better, because it’s not going away.

    As for standardization, I fear the cheesecake analogy by Dr. Gawande was a most unfortunate one as it was widely misunderstood. There is no question that process needs to be standardized, both treatment process and diagnostic process. It is the variation in these processes that leads to so many cracks which patients fall through. No one intends to tell docs how to think – as long as they DO think.

    If I sound like an old geezer, I feel like one, but I can attest that the general quality of medicine has fallen during my career, and I believe it is due to chaotic processes and burial under mountains of data as medical knowledge and technology has surpassed our ability to handle it. Let’s try some solutions instead of just wishing for things not to change. They have to change.

  7. legacyflyer says:

    It is a GIGO problem.

    As a Radiologist, I depend on referring docs (and their designees) to provide me with the reason for the exam.

    You would think that an EMR and/or computerized systems would improve what I receive. I has not.

    Here are some examples of clinical information that I receive:
    “Pain”
    “R/O Pain”
    “Doctors orders”

    This problem has not improved over the 25+ years I have been in practice.

    EMRs and other computerized systems allow for the facilitated transmission of worthless information. In essence, we have made it easier to “spam” ourselves.

  8. Whatsen Williams says:

    Dear Bev,

    The “mountains of data” are now screens of legible gibberish. More errors caused by the CPOE and EHR libraries of chaotically presented gibberish than by paper charts and the scourge of “bad handwriting”.

    Striking, for me, an absent chart was extraordinarily rare, and never caused a death, whereas innumerable deaths have occurred that I see from bad HIT.

  9. Whatsen Williams says:

    Dear Bobby,

    Your demand statement leaks your naïveté and your anxiety about learning that the HHS has confessed in its safety tomb that it was wrong to promote devices that are experimental.

    • BobbyG says:

      You make an assertion like that, back it up (you can’t; I know). By the way, troll, I posted about the HHS thing on my REC blog as soon as it hit the wire. So much for my “naïveté” and “anxiety.”

      I want to see the police blotter on these “innumerable” HIT caused deaths.

      A veritable EMR Holocaust, I tell ya. Just wait ’til the MedMal lawyers find out.

  10. Quant says:

    Taleb is an excuse for avoiding careful statistical work, apparently.

    • BobbyG says:

      Not sure, but then, I’ve not yet read his new book (I’ve read his others, and most of his papers). Could he be ossifying into the Michael Crichton of contemporary philosophy?

  11. integrity says:

    BobbyG is such a man, dumping on Whatsen who makes innumerable valid points.

    My I ask, if HIT is so great, why is the HHS confessing to its experiment gone bad?

    • BobbyG says:

      But, we don’t know who he is (just like you), nor do we have the coroners’ reports on the “innumerable” HIT-cause deaths he alleges.

      “why is the HHS confessing to its experiment gone bad?”

      Try to spin it any way you wish.

      Belittle me, fine, go right ahead. Helps avoid the point.

  12. frye shoes says:

    Your demand statement leaks your naïveté and your anxiety about learning that the HHS has confessed in its safety tomb that it was wrong to promote devices that are experimental.

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