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Republicans Run from Voucher Label

What’s in a name? Everything, it would appear, when it comes to describing Rep. Paul Ryan’s plan to privatize Medicare, which the Republican-controlled House of Representatives backed in its budget resolution late last month. The plan would subsidize seniors’ purchase of private insurance plans instead of enrolling in traditional government-financed Medicare, although that would be preserved as an option. The government would finance a portion of the purchase.

Architects of the plan call it “premium support.” Opponents call it a voucher, which they say will over time lag behind medical inflation and force seniors to pay an ever-growing share of their health care bills.

Ten Republicans joined every Democrat in voting against the resolution, which passed 228-191. The Republican apostates abandoned their majority colleagues largely because they were afraid of being tarred with the voucher label during this fall’s re-election campaign.

And it was that label that Republicans on the House Ways and Means health subcommittee repeatedly attacked during Friday’s hearing on the Republican plan, which has not yet been introduced as legislation. Its details have not yet been scrutinized by health care experts or, more significantly, the Congressional Budget Office. “Premium support is not a voucher,” Ryan, R-Wis., said at the hearing.

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Is Your Doctor Lying To You?

The doctor-patient relationship, like any good relationship, is built on trust. After all, the patient is naturally at the mercy of their physician in most cases, because the physician is the expert. Sure, the patient should have the ultimate say in their care, but the information they are basing their decisions on typically comes from the physician, and they must trust that what they are being told is the truth. Unfortunately, a recent study by Lisa Iezzoni and colleagues finds that doctors aren’t always so honest with their patients.

In a survey of a representative sample of physicians, more than a third of doctors fail to completely agree with the statement “Physicians should disclose all significant medical errors to affected patients.” Nearly one-in-five fail to completely agree with the statement “Physicians should never tell a patient something that is not true.” That’s right, more than 17% of doctors felt that there were times when it was okay to lie to patients.

As for their actual behavior, 11% of physicians reported rarely, sometimes, or often (in contrast to never) telling a patient something that was not true, and 55% reported rarely, sometimes, or often describing a patient’s prognosis in a more positive manner than warranted. Admittedly, the latter case could be perceived as compassionate rather than dishonest depending on the circumstances.

What are we, as patients, to make of these findings? Well, on the one hand, the truth could be even worse than the results suggest because of “social acceptability bias.” In other words, doctors know that admitting to being dishonest isn’t the “right” answer to give, so they may ironically be dishonest about reporting their dishonesty. At the same time, the framing of the results may actually be misleading. By taking four responses (never, rarely, sometimes, and often) and grouping them into two categories (never vs. not never), important information is obscured. If most of the doctors who admit to lying are in the “rarely” category, perhaps that’s not so bad. If, on the other hand, most of them reported lying “often” that’s a little scary. Unfortunately, the way the data are presented, it isn’t clear which is the case. I think it would have been better to put two responses in each category so that “never” and “rarely” were combined and compared to “sometimes” and “often.”

My sense is that doctors, like all people, sometimes lie–perhaps more often by omission rather than commission–but that we should not be too worried about the results of this survey. Don’t assume your doctor is lying to you or that they are always being honest. That’s what second opinions are for.

D. Brad Wright is postdoctoral fellow at Brown University and  holds a PhD in health policy and management from the University of North Carolina.  He has worked as the Assistant Director of Health Policy for the Association of Clinicians for the Underserved. You can follow him at his blog Wright on Health where this post first appeared.

Will High Court Tamper with Cost-Cutting Reforms?

Spending on health care is slowing down – a much-needed development since the nation’s long-term deficit problem is largely tied to projections that spending on Medicare and Medicaid will remain out of control.

But slowdowns have happened before, and there’s no guarantee that this one will last. The Supreme Court in the next few weeks could rule the entire health care reform law unconstitutional, which would be a blow to cost-control efforts since at least some of the recent slowdown is being attributed to delivery system changes sparked by the law.

During the mid-1990s, in the wake of the Clinton administration’s failed health care reform effort, an insurance industry that perceived it had a public mandate to take radical steps to hold down costs switched millions of Americans into health maintenance organizations. They succeeded in holding down costs for a while, but the effort collapsed when patients rebelled against the industry’s ham-handed tactics in denying needed care.

In the 1980s, another period when health care costs were growing faster than the economy as a whole, Medicare switched hospitals to a new payment system known as “diagnostic related groups.” Instead of getting paid a fee for every service or product, hospitals received a set payment for an entire procedure – an appendectomy, for instance, or a heart transplant.

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Connected Health Predictive Analytics: A Long Road Ahead

We’re spending a lot of time at the Center for Connected Health (CCH) these days thinking about and experimenting with algorithms.  It’s part of our general interest in micro-segmenting the population and creating unique, engaging health messaging for each individual that will keep them on the path to better health.  Healthrageous is working fast and furious on this as well.  Of course, we’re not the only ones.  A number of other labs and firms are on the same journey.  The vision is compelling.

However, today when you get health related messages from your insurer or another source, they are typically public health focused.  Stop smoking!  Get your mammogram! Get your flu shot!  These three messages illustrate the challenge. I’ve been the recipient of all of them recently.  I’ve never smoked, clearly do not need a mammogram and was vaccinated for influenza in early October.

I always thought our friends on the consumer web side were doing better.  The first time you experience Amazon’s or Netflix’s recommendation engines, they tend to raise eyebrows.  Over time, the experience is less salient.  And let’s face it, it’s got to be easier to guess which type of movie I might want to watch or a book that might interest me than to predict what a really engaging health-related message might be.

At CCH we’re in the middle of an interesting trial funded by the McKesson Foundation, where we collect three types of data (a measure of readiness to change, ongoing activity data and location data) and use an algorithm to generate motivational messages based on these variables.  It’s ongoing now, so I don’t know how it will turn out, but we’re excited about the possibilities. Still, it’s only three variables and only one (activity level) is continuous. My instinct is that we have a long journey ahead of us.

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WSJ to Biotech: “You’re All Going To Die.” Thanks – Now Let’s Keep Fighting.

Friday’s WSJ features a brutally – I mean brutally — frank article about the dismal state of biotech financing.  There are few revelations (certainly not for those readers of this column who I know follow the space closely), and unfortunately, few patches of sunlight.   This clip from Play It Again, Sam pretty much captures the tone.

The crisis in financing is having a chilling effect on biomedical innovation.  As discussed in my last column, the main problem in our industry is that the sheer cost of drug development has become almost prohibitively expensive, effectively pricing almost everyone but the largest companies out of the market.

While my Forbes colleague Matt Herper suggests this could represent a disruptive opportunity for ultra-lean start-ups, I don’t think this is true in practice.  For a start-up or small company, figuring out how to run trials in an extremely capital-efficient way isn’t a competitive advantage, it’s table stakes – it’s what gives you a shot on goal, or maybe two.  Given the intrinsically high likelihood of failure, long-term survival requires the ability to advance a portfolio of products through clinical development, something that typically only fairly large companies can afford to do.

The broader challenge is how can you achieve disruptive innovation in a highly-regulated industry?

One approach is to avoid regulation – this is one of the reasons so many digital health companies are pursuing consumer health – they hope to avoid the regulatory morass that has so dampened progress in the medical products industry.  As I’ve noted before, it will be interesting to see how this works out – I’ve see a lot of cutsie apps out there, but not much that seems likely to deliver measurable improvements in patient health (i.e. improvements that would be meet the sort of standards both demanded by drug regulators and expected by physicians).

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The Road Not Taken: The Unrecognized Harm of Excessive Regulation

The difficulty of creating new and better medicines has been the subject of extensive – at times excessive – soul searching, a process that’s intensified as high-profile patents expire, along with their associated revenue streams, traditionally relied upon to support future R&D.  As a result, both biopharma companies and patients awaiting new treatments find themselves struggling for viable solutions.

Predictably, industry (where I obviously reside) attributes excessive regulation, regulators say “don’t blame us,” and considered reporters and observers typically try to split the difference – maybe everyone is a little bit at fault.

The problem with this resolution is that it’s a cop-out; while there is clearly a measure of shared responsibility, it’s willful blindness not to recognize the extent to which a deliberate and very conscious regulatory policy is putting a damper on what has traditionally been the world’s most vibrant drug development ecosystem.

It’s not that other factors (such as the complexity of science) aren’t important – in fact, it’s precisely because developing new drugs is challenging, so inherently difficult, that’s it’s crucial to do everything within our control to work together and create an environment, an ecosystem, that stimulates and enables meaningful innovation.

The most significant – and potentially, most correctable (which is why it’s especially frustrating – it’s explicitly of our own making) problem – is that regulators, as others have astutely observed, seem to have misapplied the “precautionary principle,” colloquially understood as “first, do no harm.”  The problem isn’t so much the sentiment as the way it’s reduced to practice.

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The Rule of Thirds

When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there — they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, “I’m gonna teach you one thing today.” And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore “I’m gonna teach you one thing today” promise. Well, today is one of those days: I’m gonna teach you one thing.

And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the “Zilberberg rule of thirds.” The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the “sweet spot” for intervention. So it is a fool’s errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.

Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.

In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:

1. Is the disease in question prevalent?

2. Is the economic impact of the disease known and substantial?

3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?

If the answer to any of the questions above is “no,” you really need to think carefully about the value proposition.

Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding “no.” So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.

And that is your one thing for today.

Marya Zilberberg, MD, MPH, is a physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is the Founder and President of EviMed Research Group, LLC, a consultancy specializing in epidemiology, health services and outcomes research. She is also a professor of Epidemiology at the University of Massachusetts, Amherst. Dr. Zilberberg blogs at Healthcare, etc.

Racing to Nowhere

I had dinner over the weekend with a close friend who is a breast cancer survivor (her word) and a former avid participant in the annual marathons sponsored by the Susan B. Komen Foundation. Her status as a former activist was new. “Is this what we were racing for?” she said. She is skeptical by nature, and the brouhaha over Komen’s back-and-forth over funding Planned Parenthood last week didn’t make her angry. It merely flipped the switch that changes skepticism into cynicism. To paraphrase the old Phil Ochs song, she ain’t a marchin’ anymore.

I try to avoid bringing my knowledge about medical issues into private discussions (I’m not a doctor, and I take that caveat seriously. But as readers of this blog know, I’ve written extensively about recent controversies in breast cancer research, including the dust-ups over the U.S. Preventive Services Task Force recommendation that women under 50 can eschew mammography, and the Food and Drug Administration’s decision to withdraw Avastin’s approval for breast cancer). Yet my friend asked me pointedly about what I thought about Komen and why they did what they did. She knew nothing about the organization she had been supporting for many years, and now wanted answers.

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I am seeing the world of medicine change before my eyes, and I wonder where we’re going.

Never before has there been more information at our disposal, yet more confusion. Like molecules being heated, the Brownian motion happening in medicine seems completely ineffectual for those of us on the front lines of care, geared more toward expensive facades than substance.

For the most part, doctors keep their heads down. Most of us are busy caring for patients, pushing to get home at least once each week before dinner. Most are humble servants to their patients, working tirelessly for their benefit. Sure, there are a few doctors participating in policy or medical associations, but it’s clear to the rank and file that their leadership has already cashed out from patient care and are no longer participants in what medicine has become today. Worse: they’re too few in number and too underfunded and occassionally displayed as hood ornaments to validate a central policy decision.

Then there’s call. No one likes call, but it must be covered. Doctors understand that medicine is 24/7/365 affair. But there’s more people now, more places, and yes, more call. The burden falls on the doctors, so the tremors resonate louder. No large ones, mind you. But they’re happening. Doctors are pleasantly, professionally, reaching critical mass.

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Fraudulent Cancer Research: An Exception or the Tip of the Iceberg

Yesterday, 60 Minutes reported on Dr. Anil Potti, researcher at Duke University.  Dr. Potti supposedly offered cancer patients improved cancer treatments.  These recommendations, however, were based on falsified data.

“Five years ago, Duke University announced it had found the holy grail of cancer research. They’d discovered how to match a patient’s tumor to the best chemotherapy drug. It was a breakthrough because every person’s DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke’s innovation.

In 2010, we learned that the new method was a failure. But what isn’t widely known, until tonight, is that the discovery wasn’t just a failure, it may end up being one of the biggest medical research frauds ever – one that deceived dying patients, the best medical journals and a great university.”

When the National Cancer Institute found they could not replicate Potti’s results, Duke suspended the enrollment of patients in the Potti study and asked outside review committee to analyze Dr. Potti’s discovery. After three months, however, the review committee concluded that Dr. Potti was right.

Why did no one find out earlier.  Were researchers blinded by money?

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