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New Interventions Needed to Halt the Growth of “Superbugs”

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By Brad Spellberg, MD

How do you tell the family members of a critically ill patient that their loved one is going to die because there are no antibiotics left to treat the patient’s infection?  In the 21st century, doctors are not supposed to have to say things like this to patients or their families.

Ever since the discovery of penicillin in 1940, patients have expected a pill or an intravenous injection to cure their infections. But our hubris as a society with respect to antibiotics has been exposed by the rise of antibiotic-resistant “superbugs.”

The Centers for Disease Control and Prevention (CDC) recently issued a new study, entitled “Antibiotic resistance threats in the United States, 2013,” reporting that at least 2 million people become infected with bacteria that are highly resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. These estimates are highly conservative.  Many more people die from other conditions that were complicated by an antibiotic-resistant infection.

Meantime, we have ever-decreasing new weapons to wage the war against such infections because the availability of new antibiotics is down by more than 90% since 1983.

Interventions are needed to encourage investment in new antibiotics, to prevent the infections in the first place, to slow the spread of resistance and to discover new ways to attack microbes without driving resistance.

A major reason for the “market failure” of antibiotics is that they are taken for short periods of time, so they have a lower return on investment than drugs that are taken for years (such as cholesterol-lowering drugs).  The Food and Drug Administration can help reverse the market failure by adopting new regulatory approaches to encourage development of critically needed new antibiotics.

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Seriously? Are We Really Going to Re-Legislate Healthcare Reform?

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By Christopher Robertson

A minority of the Members of Congress are threatening to cause the United States government to default on its debts, unless the majority members agree to repeal or defund the Affordable Care Act, which Congress passed just a few years ago.  There will presumably be some sort of negotiated solution.  I worry that the negotiation range is being defined in a skewed way, between one pole and a moderate status quo, which is already the result of a prior negotiation.  Seems like we have a one-way ratchet here.

My thought:  perhaps the negotiations should go both ways, so that the end-result is more balanced.  What if the Democrats made symmetric threats to cause default, unless:

  • Medicare is expanded to cover all the poor who do not qualify for Medicaid (filling the gap the Supreme Court created in its “coercion” opinion),
  • The Federal government creates a public health insurance option, to compete along with the corporate insurers (which was killed in final negotiations to pass the ACA),
  • The Federal government gets explicit authority to provide insurance subsidies in the health insurance exchanges it sets up for states that have refused, oh and, as a kicker,
  • Ronald Reagan International Airport (DCA) is re-named Jimmy Carter International Airport.

Ok, that last one is silly, but it might make for a fun bargaining chip, since it symbolizes the strategic game that is now being played, as we re-legislate settled questions.  Positional bargaining is not pretty or enlightened, but if these chips can be traded, we might end up in the fallback position of keeping the Affordable Care Act as the negotiated compromise that it already is.  Of course, the ACA is also the default rule, which has a nice double meaning in this context.

Christopher Robertson, JD, PhD is a visiting professor at Harvard Law School,  an associate professor at the James E. Rogers College of Law, University of Arizona, and a research associate with the Edmond J. Safra Center for Ethics at Harvard Law School. He blogs at  the Petrie-Flom Center’s Bill of Health, where this post originally appeared.

Repealing Laws By Defunding Them

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By Robert Reich

Sunday morning on ABC’s “This Week,” Newt Gingrich and I debated whether House Republicans in should be able to repeal a law — in this case, the Affordable Care Act — by de-funding it. Here’s the essence:

GINGRICH: Under our constitutional system, going all the way back to Magna Carta in 1215, the people’s house is allowed to say to the king we ain’t giving you money.

REICH: Sorry, under our constitutional system you’re not allowed to risk the entire system of government to get your way.

Had we had more time I would have explained to the former Speaker something he surely already knows: The Affordable Care Act was duly enacted by a majority of both houses of Congress, signed into law by the President, and even upheld by the Supreme Court.

The Constitution of the United States does not allow a majority of the House of Representatives to repeal the law of the land by de-funding it (and threatening to close the entire government, or default on the nation’s full faith and credit, if the Senate and the President don’t come around).

If that were permissible, no law on the books would be safe. A majority of the House could get rid of unemployment insurance, federal aid to education, Social Security, Medicare, or any other law they didn’t like merely by deciding not to fund them.

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Commentology: Where Do Apps Go When They Die?

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The developers of  the app Pain Care, the winner of the Robert Wood Johnson Foundation’s Project Health Design challenge two years ago,  have this to say about THCB contributing writer Dr. Leslie Kernisan’s recent post wondering why the winning entries of development challenges have a habit of  disappearing and never being heard from again:

We are the app developer. We are also disappointed with the outcome of the app. But I think we also learned valuable lessons here.

One of the challenges small business facing is the need to rapid prototype and test the market, and then move on to another idea when the previous idea fails to gain traction. That is especially true with grant funded projects — they need to “make money” after the grant ends in order to justify continued development effort.

Pain Care was developed in the early days of mHealth, and it was indeed very physician focused — the reason is that we believe we must engage physicians to look at the data. We still hold that belief. It is a learning process for us. We put in our own money to develop the app, and fortunately, won the developer challenge.

We made the app public after the challenge to “test the market” — so to speak. But, as you know, essentially *none* of the pure app-based “patient journal” has turned out to be a success (let alone a financial success). Our app is no exception. It is enormously costly keep the app updated for all those iPhone, iPad, iOS released every year, as well as thousands of Android devices released since then.

So, the app becomes one of those “outdated” apps in the app store, and I think it is quite obvious to users as well. However, I think the app did contribute significantly to the “science” of mHealth. We now understand much more what works and what not in “patient engagement”. Many other “pain management” apps have since emerged, and many have done a better job than ours. I think that was what RWJF wanted when they challenged developers back then. :)

Today, we do things a lot differently. We no longer release research grant-funded apps to the public. Instead, we run clinical studies to test them in much smaller / controlled groups. We do not attempt to tackle vague “big problems” like general pain management any more — instead, we are much more focused on managing specific diseases that include pain. We are also moving beyond “pure software” and “simple reminders” to engage people in multiple modalities.

All of these would not be possible without the generous award RWJF gave us in picking Pain Care as the winner of one of the first developer challenges.

Moving Beyond the Sick Care Model

By Lori Houston

How does a corporate behemoth heavily invested in the transaction-based health care system of today make the shift to engaging with its 20 million+ customers about their health in new and deeper ways? Humana’s new CEO Bruce Broussard sees technology as key to successfully meeting this challenge.

The company does a good part of its $39 million annual business in one of the health system’s status quo areas: providing medical benefit plans to employer groups.

In his October 1st keynote at the Seventh Annual Health 2.0 2013 Fall Conference, Broussard will share some thoughts from the executive suite about the role Humana envisions for itself as part of health care’s future. Health 2.0 co-founder Matthew Holt recently chatted with Broussard about Humana’s plans.

Matthew Holt: Humana has been looking to get involved in the new changes in health care as a whole. I know you’ve been surveying the role of new information technologies and tools in recent months.

What kinds of things are you seeing? What has most surprised you about the possibilities?

Bruce Broussard: The informational tools that are coming out are pretty powerful. I’d categorize them as allowing individuals and companies like Humana to educate and motivate individuals, and to gain easier access to providers and to more timely treatments.

When we look at the new tools coming out, I think these are going to greatly improve health care in multiple ways.

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Top Twelve Reasons to be at Health 2.0 Next Week

By Matthew Holt

And now, for your crassly commercial consideration, I am emerging from my bunker/email queue and relentless rehearsing of 150+ demos to tell you the Top Twelve reasons why you need to join over 1,600 others at the 7th Annual Health 2.0 Fall Conference which starts with pre-conferences on Sunday 29th and kicks off officially on Monday 30th September:

Twelve Teams creating new on-body laboratory grade sensors competing for $2.25 million in prizes in the Nokia Sensing XCHALLENGE

Eleven Pre-conference sessions including International Health 2.0, a design workshop from Mad*Pow on behavior change, Patients 2.0, Doctors 2.0, Employers 2.0 and more!

Ten New Companies introducing their brand new products to the market in Launch!

Nine Developer Challenge Competitions with winners & new challenge announcements on stage!

Eight Start-Ups Competing in the DC to VC start-up showcase from Morgenthaler Ventures with 8 VCs as team captains

Seven Sponsored Deep Dive Sessions from leaders Janssen,  United Healthcare, Cigna, Airstrip, Health Dialog, NaviNet &  The Iron Yard (featuring 10 startups from the South)!

Six Demos showing the latest tools for and about health consumers on our panel called Big Data: Tools & Applications for Individuals

Five Networking Parties for attendees, sponsors, and exhibitors!

Four Cutting-Edge Revolutionary Demos on the Frontier of Health 2.0 panel including Syapse, BrainControl and from the labs of Adam Gazzaley at UCSF and Louis-Philippe Morency at USC.

Three Female Health 2.0 Rising Stars: Akhila Satish, CyberDoctor; Hind Hobeika, InstaBeat; Julia Winn, BetterFit Technologies.

Two Engaging Keynotes by movers and shakers –Bruce Broussard, CEO of Humana, and Gavin Newsom, Lt. Governor of California.

One Revolutionary Health Technology Conference you don’t want to miss!

And honestly we could have done a top 100! You can find out more and sign up here! And, to quote a recently late Silicon Valley legend, it will be insanely great.

State Insurance Exchange Blind Spots: Unknown Risks and Unintended Consequences

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By Seth Kneller

October 1st marks the first ever public exchange open enrollment season.  This means some of the speculation around consumer awareness and understanding, enrollment/uptake, premiums, and payer participation (not to mention the technical readiness of the exchanges) will finally subside and give way to a clearer picture of the PPACA’s initial success in mandating individual health coverage.

Despite this approaching level of clarity, however, several very significant “blind-spots” will continue to persist, principally for the health insurance carriers that choose to participate by offering PPACA compliant plans in the exchange.

This is due to the law’s guaranteed issue mandate prohibiting health carriers from denying coverage based on preexisting conditions.  As a result, the traditional enrollment process which consists of a comprehensive assessment of each applicant’s health status and risk cast against the backdrop of time-tested underwriting guidelines is completely thrown out.

What takes its place is an extremely limited data set (i.e., the member’s age, tobacco/smoking status, geographic region, and family size) from which carriers can determine pre-approved premiums and variability therein.  To use an analogy, health insurance companies no longer have a “bouncer at the door” turning people away, or a sign reading No shirt, No shoes, No service at the entrance.

In other words, everyone, regardless of their risk profile, must now be welcomed in with open arms and with very limited risk-adjusted rates.

This wouldn’t necessarily be a problem if the enrolling population comprised a well understood risk pool representing a true cross-section of the population.  The reality, however, is that a predominantly unknown and potentially unhealthy population will flood the individual health insurance marketplace in a two weeks just as most states quickly phase out their high-risk pre-existing condition pools and shift them into the exchanges.

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The Summer of Wellness’s Discontent

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By Al Lewis & Vik Khanna

The series of unflattering articles published in Health Affairs early this year – the first unfavorable press wellness had ever received in a top tier policy journal — turned out to be a harbinger of what became the wellness industry’s summer of discontent.  Perhaps in error, the Journal of Occupational and Environmental Medicine (JOEM) also drifted into the sea of credibility on wellness early in 2013 by publishing a meta-analysis of the industry’s claims of economic success.

The analysis, by researchers at Tufts, destroys the industry mythology of respectability by noting that out of over 2,000 papers published in the world’s medical literature, only 10 (0.5%) are worth discussing and that discussion leads essentially nowhere.  Not surprisingly, like our essays here and in Health Affairs, the Tufts work has been universally ignored by the wellness true believers.

Starting with those articles, and especially over the last four months, those true believers have lost control of the dialog — starting right here with THCB, which gets credit as the first major regular source of objective news not generated by the wellness industry’s propaganda apparatus.

June brought the RAND report, our Wall Street Journal op-ed, and Cracking Health Costs.  Unlike Health Affairs, some HR administrators have actually read those publications.  These developments left them asking uncomfortable questions of an industry that hitherto had filtered the information that its customers received through the JOEM and the Journal of Health Promotion, the industry’s de facto house organs that between them in thirty years have published fewer articles concluding wellness doesn’t work (just that single meta-analysis mentioned above) than Health Affairs has in 2013 alone.

But it wasn’t until July that the wheels fell off the wellness bus, due to four self-inflicted wounds that did more to diminish the industry’s carefully cultivated albeit totally undeserved patina than anything we could have written.    Atoning for its brief foray into accuracy, JOEM published an article showing $20-million in savings for British Petroleum’s (BP) wellness program, 100 times what the vendor, Staywell, claims on its own website to be possible.

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Why Can’t We Do Better Than This?

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By Harlan Krumholz, MD

Is there a patient who goes through a hospitalization who does not have stories to tell about the obstacles, errors and indignities that they endured? I just wonder sometimes.

A family relative was hospitalized this week with a stroke at a hospital a few hours from me –and his experience left me demoralized about medicine.

Joe (not his real name) is an 82 year old grandfather, father, husband and one of a kind. He has a scraggly beard and ponytail. He possesses an artistic spirit, but is punctual to a fault – always early, never late. He has an integrity that is rare these days, which led to a loyal following in business and life. And yes, he is devoted to his family.

On Tuesday, he developed some difficulty with his balance. His wife of over 60 years was worried and brought him to the doctor.  That is when the issues began.

Issue #1. His doctor fit him into her schedule and recognized the possibility of the early signs of stroke and sent him for an MR imaging study of his brain. And she also gave him an aspirin, which he promptly took. The problem is that the MR study revealed a small bleed in his brain – and the last thing you want to give someone bleeding in his brain is an aspirin because it can cause more bleeding.

Issue #2. At one of the nation’s most reputable New England hospitals he was evaluated in the Emergency Department and admitted to the hospital. He is brought upstairs to the stroke ward fairly late and he is exhausted. Even later he is told that he must have a CT scan of the brain.

He is stable. His symptoms are not changed. Nevertheless, someone orders a CT scan. There was no discussion about whether he should have the scan with Joe’s family; they were told he needed to have one. After the scan, his family is told that the scan will not be read until the morning when the radiologist arrives. They push and are told that the technician looks at the scan and would let someone know if it looked abnormal.

They push a little more and ask that they speak to someone who is managing his case. A resident arrives and tells them that there is nothing alarming. The family asks if it will be compared with the scan from earlier in the day  (as that was the reason they took the scan 6 hours later) and are told that scan hasn’t been uploaded yet, even though it was with Joe’s records when he was in the Emergency Department.

They ask the resident to retrieve it from the emergency room and make the comparison. Finally they are told that the Radiologist in the ER reviewed it – but when they ask who reviewed it, they are not told a name.

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A Physician Faces Disciplinary Action For Seeing Patients on Skype — Early Guidelines For Patient Video Visits

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By Joseph Kvedar, MD

The medical board of the state of Oklahoma recently sanctioned a physician for using Skype to conduct patient visits.  A number of other factors add color to the board’s action, including that the physician was prescribing controlled substances as a result of these visits and that one of his patients died.  This situation brings up several challenges of telehealth — that is, using technology to care for patients when doctor and patient are not face-to-face.

• Legal/regulatory: On the legal side, physicians are bound by medical regulations set by each state.  It appears that the use of Skype is not permitted for patient care in Oklahoma.

• Privacy/security: Skype says its technology is encrypted, which means that you should not be able to eavesdrop on a Skype call.  That would seem to protect patient privacy.  At Partners HealthCare, we ask patients to sign consent before participating in a ‘virtual video’ visit.  Because this is a new way of providing care, we feel it’s best to inform our patients of the very small risk that their video-based call could be intercepted.  I don’t know if the Oklahoma physician was using informed consent or not.

But the most interesting aspects of this case involve the question of quality of care.  Can a Skype call substitute for an in-person visit?  Under what circumstances?

Video virtual visits are a new mode of care delivery.  Whenever anything new comes up in medicine, it is subject to rigorous analysis before entering mainstream care.  That same rigor applies to video virtual visits.  Although some studies suggest virtual visits can be useful, the evidence is not yet overwhelming.  I can’t say with 100% certainty how virtual visits will best be used, but based on several pilot programs under way at Partners, I have a hunch or two.

We have believed for some time that this technology should be limited to follow up visits, where the patient and physician already have a well-established relationship.  Technologies such as Skype and Facetime allow for a robust conversation, but most doctors’ visits require much more than just conversation.  For example, any time a physical exam is required, this technology will not work well.  That’s why one of our first pilot studies was to implement video technology for mental health follow up visits (as did the doctor in Oklahoma).

Our early results are promising.  It seems that virtual video visits for mental health offer both the provider and the patient important benefits.  For many mental health patients, it can be stressful to travel to the doctor’s office.  When a patient is being evaluated for a medication adjustment, for example, they are not at their best.  The convenience of having a follow-up visit from their own home can be a big lift for these patients.  On the other hand, doctors often feel that the home environment is particularly relevant in sorting out mental health problems.  A virtual visit allows them to, in effect, conduct a virtual house call.

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