The Cost of Safety

At a time where the nation is struggling with a debt crisis driven in large part by the cost of our health care entitlement programs Medicare and Medicaid, the press reports of larger hospitals with fewer beds continue:

A southwestern Indiana hospital expects to start work in the coming months on a $100 million construction project to replace much of its existing facility that has parts dating back more than a century.

The master plan for the project approved by Good Samaritan Hospital's board includes a new 120-bed, five-story inpatient tower.

The completed project will see the hospital's capacity drop by 67 beds to 165, but Good Samaritan President Rob McLin said it will allow for growth in areas such as oncology, orthopedics and cardiology care.

You can never be too safe. Infection control requires single rooms with big screen TVs that have internet and personalized meals. Really it does.

No matter what the cost, it's safety, safety, safety. Entire institutes full of safety experts have sprung up the help hospitals make sure they keep the message coming and to fufill the lofty goal of never having a readmission. Hopsitals pay these institutions hefty sums to make sure they comply with mandated safety classes for all of their employees. In fact, these lessons is so important that they even give their directors millions of dollars of safety-inspired compensation packages to make sure their family members have a lifetime of safe health care after they retire.

And then there's that not-so-little issue of medical equipment expiration dates. Imagine if one of those foam headrests in the operating room were to expire! "You can't use those any more, doctor, they're expired!"

So we throw them away and order more.

In every hospital across our land this happens. Tons and tons and tons of medical waste because of expiration dates for things that, practically, shouldn't have expiration dates. But because we have regulations regarding how long things can sit on shelves in hospitals, we label them with expiration dates. "Order more, please." After all, if the Joint Commission finds expired headrests, hospitals might lose their accreditation. Our medical supply industry, full of middlemen like group purchase organizations that exist to get a better deal on bulk orders (really), is only too happy to comply.

My point here is not to speak badly of the need for safety in hospitals, rather a need to gain some equipoise on the subject. It is true that we've done a pretty good job improving surgical infection rates in America with things like pre-procedure antibiotics, antibacterial drapes, and good technique. But I wonder what's more expensive for our system in the long run, hand washing with soap and water or foam alcohol dispensers that have cannisters that have to be refilled and repurchased time and time again. what about all those plastic gowns we wear because a nasal swab shows traces of the genetic makeup of a single methicillin-resistant bacillus in a patient's nose? Or might all that plastic we purchase ultimately become more expensive to our health care system and environment in the long run?

These are not convenient questions to ask. But, given our concerns about the costs of health care and its affect on our economy, it seems to me that doctors AND patients had better start looking for (and demanding) ways to save money with the little things we do every day that might not be viewed as perfectly safe but rather, perfectly acceptable.

-Wes

Rebuttal: The NEJM's Justification of Medical "Mystery Shoppers"

The proposed examination of access to primary care according to insurance status in nine representative states was largely derailed by physicians and other critics concerned about the potential for government invasion of physicians' privacy. They argued that less controversial survey methods would suffice or that additional studies of the well-known primary care shortage are a waste of public resources. I think these arguments are misguided.

- Karin Rhodes, MD NEJM, July 27, 2011 (10.1056/NEJMp1107779)

Fair enough, Dr. Rhodes. You certainly are entitled to your opinion.

But before I take on my rebuttal to your piece, let's both be clear on a separate issue: what is most misguided about your perspective piece in the New England Journal of Medicine was that comments were not allowed. If they were, the "physicians and other critics" could explain their aversion to these tactics.

So, let me be the first to state my position.

Covert, subversive tactics in research in an attempt to avoid bias carries the risk of introducing additional forms of bias. For instance, when a phone call is made to a doctor's office for a new patient appointment and the problem sufficienctly urgent that other real live patients are rescheduled to accommodate a mystery patient's needs, how, exactly are the affects and costs to the established patients compensated? How will those data be "counted" in your statistics when your one new patient's access if offset by the loss of two follow-up patient's access. Who will explain to those affected by these tactics why they were rescheduled? Will you?

You claim that "the study was intended to generate valid national estimates of primary care capacity before the anticipated expansion of private and public insurance to as many as 38 million currently uninsured Americans."

First, recall the problems with that "38 million" number. Wasn't that number "47 million uninsured not too long ago?" Right off the bat, we see how numbers can be spun in policy circles, Dr. Rhodes. Which leads to the most important question that remains unanswered regarding a study that uses these covert tactics: how will the data be used? Will the data (which most certainly are going to "discover" problems with access) be used to justify mandates to shorten office visits from 7.5 minutes per patient to 7 minutes per patient to improve access? Or might doctors be directed to see more patients that are not insured? Seriously. What policy directives can we expect from these data?

You justify the use of this deceptive practice saying "the use of masking and concealed allocation, widely endorsed for randomized, double-blind clinical trials, lends confidence to the interpretation of results." And yet in the circumstance of randomized, controlled trials, patients must sign informed consent to take part in such a study before they are randomized. Hardly a "mystery" process. Should patients and doctors of prospective clinics not be afforded the same respect who might be asked to take part in your study?

You also seem to feel that a sampling 18% of states (9 of 50) is adequate to formulate conclusions. I find this concerning. National policy development should have representation from all states affected, not a minority. To suggest that the concerns of states with relatively high congestion mirror those with more rural populations is certain to bias policy decisions going forward and, more likely than not, exclude the perspective of less populous states.

So these are just a few of my concerns. There are others. Please note that none of them even begin to address the privacy issues raised by "others." But given the flaws I've outlined, paired with the obvious shortage of physicians that we will encounter in 2014 when the full brunt of the Patient Protection and Affordable Care Act kicks in (not to mention our limited research funding these days), this study certainly does appear to squander our limited public resources. Must we spend our resources to become Masters of the Obvious?

No doubt others would like to share their views, so unlike the New England Journal of Medicine, I'll leave my comments open.

-Wes

Why the US Debt Reduction Talks Remain Stalled

... because one of the principle negotiators smokes and the other one quit.

-Wes

Don't Just Do Something, Stand There!

It's the hardest thing in the world for a doctor to do.

After all, doctors are do-ers. That is how they have managed to achieve their degrees: hard work, discipline, perseverence. Who else would be willing to memorize all those organic chemistry equations long enough to vomit them back on paper? Who else would tolerate long nights and weekends on a constant basis? But they do it because it's the right thing to do. They do it because someone has to. People don't get sick nine to five. They get sick at 2 am. And so, by it's very nature over the years, medical education becomes a sort of natural selection: only the strong survive.

Historically, doctors endure the system because they know that there are rewards for this hard work personally, professionally, socially, and financially. So throughout their training, doctors learn to perfect the art of doing. That's what people come to expect. Oh my God, doctor, he's choking: do something! He's turning blue: do something! But he fainted, doctor! Do something!

One of the best parts of medical school is learning the answers to these mysteries of medicine and how to fix them. In the past, this gave doctors a aura of deity: they could be trusted to fix just about any ailment that befell man. It was awesome. With time, a sense of invincibility and omnipotence set in.

And like flies to a flame, we bought it. Lock. Stock. Barrel.

In fact, our entire Greater Medical Complex has grown to support and promote the mystique. Doctors are the omnipotent, the all powerful, the experts, the purveyors of a great Center of Excellence, the Great and Powerful Oz's centered in the Crystal City. We have read the great CheckList Manifesto and installed the Electronic Medical Record. We believe! How much does that cost? Who cares! Just DO SOMETHING!

So imagine when a doctor says that doing nothing is the right thing to do. Man, what a Debbie Downer. There is no checkbox for nothing.

Everyone gets upset.

The patient is confused. The administration gets upset. And yes, even the doctor gets upset. But the doctor gets upset for reasons that most don't think of. The doctor gets upset because there is little incentive to do nothing. That's how he's paid. He must do something or people might sue him. It's not okay to do nothing in medicine any longer. Just like it's not okay to stop working at Walmart. We must stay busy little beavers. That's the way it is.

See Jane run. Work, Dick, work! No tickey, no laundry.

That's because doing nothing doesn't pay the bills and ancillary staff, or turn on the lights, or pay the cleaning crew, or groundskeepers. Doing nothing isn't acceptable when millions more need health care.

So imagine this scenario: a patient presents to you after a sudden self-limited, but nonetheless significant stroke. A million-dollar workup shows nothing after a week in the hospital with a normal EKG, ultrasounds, CT scans and full cardiovascular workup except an abnormal MRI that looks for all the world like a blood vessel was plugged in her brain for a period of time. She mentioned to the doctors, though, that she was told she once had atrial fibrillation so she's placed on anticoagulants and discharged. Several weeks later, she walks blissfully into her primary care doctor's office feeling fine but is noted to have an irregular pulse and EKG confirms atrial fibrillation which she didn't feel at all.

Quick doctor! Do something!

So she is sent to me to do something. I look, listen, poke, prod, review, then review some more. The patient is asymptomatic, has rate-controlled atrial fibrillation, is on an appropriate anticoagulant and medical therapy, yet there they sit, expectantly.

It would be easy to do something. If fact, it's hard not to. After all, they're not a 100 years old. They lead productive lives. We are trained to help. We are paid to do stuff. To order. There simply is no tangible incentive to do otherwise.

And yet, sometimes, despite the powers that be, the best thing to do is nothing. Just stand there. Take the medicine. Breath deep. Move on. No need for more studies or repeat studies. No need for catheter ablation or additional medications to control the rhythm. Really.

But you'd better be damn good at explaining why, lest the legal world come back to bite you where it hurts. So minutes upon un-billable minutes are spent explaining the options and the reasons why, all for a small "thank you for taking the time." They seem grateful leaving, but you wonder, are they? Or will they seek the answer they want to hear somewhere else?

I wonder.

Truth be known, in our system is is always easier and more lucrative to do something, but the best doctors I know are the ones who are willing when it's appropriate to place their necks on the line to say enough is enough.

-Wes

Our Polite New World of Rationing

To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”

- David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.

To win an expensive technology on behalf of patients these days, there will have be "harmony" between doctors and their professional organizations and government regulators. If not, patients lose.

At issue is a transformative technology - another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.

Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.

But that's about where the harmony ends.

The new valve is expensive and so is the procedure to implant it. Although rumor, the valve itself might cost $20,000 US. Medicare (the insurer of the elderly) pays only 80% of the costs, typically, and has an arcane coding system that pays more for the code for aortic valve "replacement" than it does for aortic valve "insertion." (For goodness sakes, doctors, stop calling it TAVI and stick with TAVR, okay?!?) Will hospitals and insurers be able to afford a run on these devices? And what about Medicare that's already struggling with a huge unfunded liability?

And then there's the whole issue that doctors can't be trusted to do what's right for their patients anymore. They are uniformly greedy, at least in the eyes of the media and the regulators. They care about themselves more than their patients and thanks to a few unscrupulous doctors (and the fee-for-service system in which they work) ample evidence exists to contribute to this perception handsomely. Marcus Welby, MD: rest in peace.

But doctors still hold sway with their patients. For regulators, this is the biggest problem. Doctors, you see, get to stare directly into the eyes of the patients (and their families) as they discuss their principle problem: their narrowed aortic valve. We have to explain the options for treatment available: (1) doing nothing (and what will happen), (2) having open heart surgery (and what will happen), or (3) inserting replacing their valve in a minimally-invasive fashion (and what will happen).

Guess which option the patient is most likely to choose?

The fear with this new technology unleashed on the public, of course, is that the implant rate will reach a fever pitch as hospitals, ever hungry for the latest technology to tout, splash their cardiologists faces over billboards and national TV promoting TAVI TAVR. Doctors, too, driven by productivity quotas, are eager to increase their caseload so they can send their kids to college. The discord with the desires of government regulators is obvious.

But if you really want to see all hell break loose, splash the images of a frail minority patient that was denied the option to receive a percutaneous valve on the basis of their age that turns to the media to expose their story.

Katie bar the door.

So we must be polite. We must demonstrate harmony. We must have databases. We must have panels of doctors and regulators and professional bodies assembled that sing Kum-By-Yah by their campfire is a great display of good will and uniform conviction to diffuse responsibility.

After all, rationing's a bitch.

-Wes

Grand Rounds is Up

Over at Medical Lessons with some nice pictures, too!

-Wes

They Can Build It, But Will They Come?

There's an interesting bet being played out across America right now, one that I'm really not sure how it will play out. It is that of continued consolidation and construction in the hospital industry.

Just at a time when the economy is in the doldrums, unemployment is at a steady nine percent or more, and people are paying more for their health care than ever before, we see large hospital systems growing and building at an unprecedented pace. Like squirrels hoarding their nuts for the winter in a panic before the icy winds of winter descend, big hospital systems are building, building, building.

Winter, of course, comes in 2014 for the hospital industry. That's when, according to our recently passed health care bill, the Patient Protection and Affordable Care Act, kicks in with its employer mandate. As it stands now, in 2014 all large employers with over 50 employees will have to purchase health insurance for their employees, or pay a $2000-per-employee fine.

It doesn't take many Betz cells to know what will happen when employers who presently pay $8000-$9000 per employee for health care benefits suddenly get the opportunity to pay a $2000-per-employee "fine." Do the math: for an employer with 3000 employees, they pay about $65.5 million for the health care benefits they're currently providing compared to a $6 million dollar "fine." Seems like a nearly 10-fold savings to me! Now THAT, ladies in gentleman, is one heck of a beneficial fine!

But just before 1 January 2014, Americans would have had to pick their OWN untested insurance plan from one of those offered by an insurer or the US government. These plans will carry certain prerequisites for coverage mandated by someone really smart on such matters in Washington DC, so be sure to read the fine print. If history is any guide, the govenment will want to make sure people have some "skin in the game" with their health care costs, so a larger portion of people's personal income will go toward paying for that insurance, whether it's constitutional or not to do so. That, you see, is the Grand Plan.

But will people come at the same pace to our great health care empires of the future?

No one knows.

But there sure are lots of things being done to make sure they do. Like "free" preventative health care screenings or free "Welcome to Medicare" physicals touted by policy makers as the new way to save money in health care.

Seems logical to me. (Not really.)

What policy pundits in the health care space don't get is that people don't want to think about being sick. They don't think much about their health care needs at all. They prefer Nascar. This is just human nature. We pay plastic surgeons to stay young. We pay health food stores huge sums of money to eat healthy foods. We exercise until we're blue in the face to keep our weight off. And for goodness sakes, we wear lots of facial products. (For the record, it is good to exercise and eat correctly to improve longevity, but let's be real: this simply delays the inevitable). My point is that people, given their own druthers, would prefer to spend their money on just about anything else besides health care.

And there will sit our Great Empirical Palaces to health care taking care of those who really have no choice but to succumb to the forces of nature: the Expensive Ones. The hospital systems that are located in affluent areas will get cold hard cash above and beyond the mandated insurance coverages to do so and likely survive. Those that cater to the indigent and less fortunate will either have to fold, or become like Cook County hospital in Chicago: a bureaucratically run institution with two separate boards trying to out-manuever the other in a political cat-and-mouse game of who gets to tell the taxpayers of Illinois what they're on the hook for and a shining example of fiscally-strapped public health care if there ever was one.

Which, of course, is what our large non-profit hospital systems are banking on: when the rubber meets the road, you'll want your health care like you want your facial products: nothing but first class for you.

But will people be able to afford such care?

They might not have a choice since the alternative health care option to this conundrum, the independent physician, is rapidly shrinking away in favor of the Grand Plan.

But the big question behind it all, of course, is this:

In the end, when we have no choice, will we really be able to afford all this product?

-Wes

How To Teach Facebook to an Eighty-Five Year Old

I got off the phone yesterday with my 85-year old mother following her fifth Facebook training exercise. Only now can I say I feel she might find this interesting after all.

The need for my mother to get on Facebook came from a clear realization of the suffocating effects of being homebound following a fractured ankle. (I wrote about this some time ago.) I was not sure how this would go. But thanks to the tireless efforts of her care team (including my sister and brother), after 9 months she can now bear "20%" weight on her ankle. Sadly, this still means she remains homebound more often than not and is stuck watching the mind-numbing boob-tube in a geri-chair for way too many hours. She found the monotony discouraging and so many others in a similar circumstance, she grew depressed and despondent regarding her condition. And having some of her kids over 1000 miles away didn't help things.

So, in a burst of social media enthusiasm, I had an idea: maybe Facebook could offer her a chance to see the outside world and to re-connect with her long lost friends and family. Easy enough, right?

Wrong.

Getting someone who's depressed, concerned and cautious about their health to ambulate to, turn on, and "engage" with a computer for any length of time is not easy. For those of us relative youngsters, this is a snap. But for the older generation: if you want to succeed having them use this medium, I've found you have to stick to it. Here's some of the obstacles I encountered:

Physical and Cognitive Challenges

For many elderly, computers are uncomfortable distractions that require fine motor skills that should be used elsewhere. Simple things like getting to the darn thing, sitting, then moving a mouse, clicking, typing are challenging enough. Add the difficulties seeing the screen to the mix and it really gets interesting. Next, asking a computer Luddite to type a URL in the address line of Internet Explorer to go to Facebook? Patience becomes your middle word.

But if you persevere and carefully guide them across these hurdles, another hurdle quickly arrives: "What was my password again?" Cognition moves slower at eighty-five. So make sure they have a note pad and pen nearby to jot a few "reminders" down. Also, if you want to have any chance at all at teaching someone how to use Facebook from a thousand miles away via phone, use the "speaker" function on the phone to communicate: they simply can't type on a keyboard and talk to you on the phone at the same time any other way.

Persevere

Despite lots of effort to cross these physical and cognitive hurdles, I still found my mother never made it back to the computer after our first session. The hurdles proved too challenging for her to adopt Facebook after one try. Too little reward for too much effort, I guess. But the doctor in me just wouldn't give up, so we tried something different: we set up "Facebook tutorial sessions." I called her to arrange a time to sit before the computer and then called her to walk her through the process again. And again. And again. And again. Each time, a few more Betz cells were activated. Things that took two hours before, took 1 hour the next time, then thirty minutes, then fifteen. Slowly, it seemed, the burden and anxiety over the computer was lifting.

Get a Computer/Facebook Buddy

The other great realization was that having someone at their side helps them gain confidence, too. My sister played a pivotal role with my mother in this respect. She helped reinforce what she was doing and helped speed the tutorials along considerably. Bottom line: the medical philosophy of "see one, do one" proves equally effective when using Facebook, too.

So we'll see. I still haven't received a spontaneous message from my mother yet, but we'll keep trying. At least it gives her a chance to see and do something different. And, who knows?

Maybe she'll soon become an internet junkie, too.

-Wes

Unwriting

Rarely have I written so much, yet published so little on this blog.

Strange.

But I think this happens more as one matures as a writer in the internet space. There are many things to consider when you write here: your tone, a desire to avoid duplication of topics, and the need to provide variety while remaining authoritative (or at least interesting). But as this blog reaches further, a strange self-imposed tacit responsibilty has emerged for me: that of staying original.

Increasingly I find more and more people on the internet become "link experts." Links provide the catalyst for topics, I suppose. Maybe this helps us all sustain our tenure in this space. Twitter, in particular, facilitates snippets of commentary attached to a link allowing instant feedback gratification but does little to allow a lengthy discussion to emerge. These links are also exceptionally transient, since the basis of the "tweet" is often linked momentarily to another person's thought, idea, concept, or video. And then it's gone.

Blog writing is slightly more static, but as any blog writer knows, it is still the frequency of publication that drives reader traffic provided, of course, that the content warrants the readership. Certainly there are periods of time for "writer's block" where ideas fail to come to one's mind. But there are also times where a myriad of brilliant thoughts are penned in haste. There's a point to be made, a story to tell, for goodness sake, don't lose it!

What I'm learning as a blogger is that there are times when the author must step back from their words and reflect. Is this an appropriate story to tell? Is it told correctly? Are there enough references? Can I really say that? More often than not for whatever reason, the author is unhappy with what he's written. He looks again at his brilliance but must accept the obvious: the piece should be "unwritten" and never published. I must have an entire library of unwritten works that have never made it to the publish key. Were they a waste of time? Not really. I learn from these mistakes.

But I'm also learning that if these ideas and prose weren't okay then, they probably won't be okay in the future. But for us writers, hope springs eternal. It is very hard to surrender your "babies" to the delete key. Still, a healthy filter must take precedence.

So forgive my lack of blog posting this week.

But for the first time I can honestly say that I think that the blog-o-sphere is better because of my brillance at the unwritten unpublished word.

-Wes

Power By Induction?

From the University of Washington: The experimental setup has a large transmission coil, at the right, connected to the building's electricity. At the left is the receiving coil, and near it is a smaller coil connected to a commercial heart pump sitting in a jar of fluid.

Interesting concept: using inductive power to possibly power a left ventricular assist devices.

Hope it works some day.

-Wes

Suddenly, A Spike in Blog Traffic

Suddenly, my blog traffic spiked to a particular page on my blog which showed a Playboy bunny tattoo (a la Hugh Hefner) overlying an implantable cardiac defibrillator that I had implanted in the past (no, not on Hugh). I couldn't figure out why...

... until now.

Thanks for the traffic, Hugh!

-Wes

Who Will Come to Own the Independent Physician Advisory Board?

From Kaiser News Network:

Sen. Jay Rockefeller (D-WV), who's one of the new board's biggest backers, says now, the biggest winners are inevitably those with the most effective lobbyists. (emphasis mine)

"The Congress often doesn't know how to say no and the Congress has a practice of never saying no, and so costs go up," he said at a recent Finance Committee hearing.

Rather, says Rockefeller, it would be better not only to insulate Congress from all those lobbyists, but to get people with more expertise on deciding how medical providers should be paid. "You want to have the Gail Wilenskys...and the Bruce Vladecks," he said, referring to former heads of the agency that runs Medicare. "People who have broad health care policy experience making those decisions."

But there's a problem. Both Wilensky and Vladeck – the former a Republican and the latter a Democrat — think the IPAB is a bad idea.

Wilensky, who oversaw Medicare for the first President Bush, says she's sympathetic to Congress's desire to insulate itself from the lobbying onslaught. But she worries that the board is limited to looking only at payments to health providers, which she says "could fundamentally alter the incentives involved in physicians and providers participating in Medicare."

In other words, it could end up driving Medicare payments so low that providers will simply leave the program, or else go bankrupt if they can't.

Vladeck, meanwhile, who headed Medicare under President Clinton, has a different problem with the board. He worries that eventually the lobbyists who are now so influential with members of Congress will become equally influential with the unelected members of the board.

"In the short term, it might theoretically work," he said. But the history with other independent regulatory agencies, like the Interstate Commerce Commission and the Civil Aeronautics Board is that over time "the regulated industries tend to capture them; and they tend to do more to protect the regulated industries than they do to protect consumers."

For the first time, we can finally put some potential names and backgrounds to individuals that might actually serve on the Independent Physician Advisory Board, according to those closest to the new Affordable Care Act.

As we can see, the individual names offered so far are people care removed from the front line of today's medical care and in many cases, are wed to the powerful interests that help control healthcare.

Bruce C. Vladeck is Senior Advisor to Nexera, Inc., a wholly owned consulting subsidiary of the Greater New York Hospital Association and worked as a Former Senior Health Policy Advisor/Co-Director, Academic Medical Centers, for the consulting firm Ernst & Young, LLP. He was a doctor long, long ago. Just not a physician. You see, according to one government source, "Vladeck received a bachelor's degree from Harvard University in 1970. He received a master's degree in 1972 and a Ph.D. in political science in 1973, both from the University of Michigan."

Gail Wilensky, Ph.D. works for project Hope developing and analyzing policies relating to health care and the economy; serves as a formal and informal advisor to government and the private sector, and writes and speaks about policies and politics of health care reform. She, too, is not a "physician."

These are names of the individuals that one of the principle proponents of the Independent Physician Advisory Board has offered as potential members of the Board: policy wonks.

Maybe this is another reason the Independent Physician Advisory Board is a bad idea: none of the members are likely to be physicians.

-Wes

Contingencies

* Bzzzzzaaaaapp *

Suddenly, the light went out. There was complete and utter darkness. Then, about 3 seconds later, the lights returned. My computer with its flat screen poised before me, remained dark. I hesitated a moment, then pushed the power button. Within a few more moments, the computer restarted. All seemed intact.

But what if it wasn't?

Today with our myriad of computer systems, electronic medical records, e-mail messages, paging systems, digital xray machines, blood chemistry analyzers, automated blood pressure cuffs, etc., etc., etc., what would happen if we had no power or functional electronic medical record, just for a week?

Could our health system function?

We have entered the era when our medical students and residents have never entered a written order and "flagged it." Our unit secretaries wouldn't have a clue how to take off an order from a "flagged" chart. How would we order a stat portable chest xray without a computer? And what about our written notes. Would they include the date and time in the lefthand column, or would that be forgotten in our hurry to write our manual progress notes? Would our digital phone systems work? How about our pagers? Doctors can no longer find manual blood pressure cuffs on our wards since hospitals have moved to automated blood pressure cuffs that upload their readings into the electronic medical record automatically. have our nurses and medical assistants lost the art of taking a manual blood pressure?

I wonder about our contingency plans. Hospitals say they have them, but do the personnel know how to function under this challenging constraint?

It is hard to say. I suspect most things would come to a standstill until power was restored. But there might be some things that would be benefitted. Length of stay times would be relaxed. So would performance measures. Even better than that, though...

..our written progress notes and consults would become a whole lot shorter.

Who knows?

Maybe a little power outage would force us all to evaluate what we're currently doing in medicine so we could do improve our efficiencies and skills until the power gets restored.

-Wes

Multaq's Off Again, On Again, Then Off Again Ride

Today was another tough day for Sanofi's dronedarone antiarrhythmic medication (marketed as Multaq®) after the prospective randomized PALLAS Trial was stopped early. The PALLAS Trial was a trial that studied the safety and efficacy of patients with chronic atrial fibrillation (as opposed to the already-approved patient population with intermittent (or paroxysmal) atrial fibrillation). It seems there was an increased number of "cardiovascular events" in the drug-treatment arm of the trial and was NOT related to problems with hepatic toxicity as previously reported earlier this year.

Patients with intermittent atrial fibrillation already on the drug are encouraged NOT to stop their drug, but rather "consult your treating physician if you have any questions."

But Multaq's path through the drug approval process has been a rocky one. First came the ANDROMEDA Study, a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms. In this study, patients given Multaq had a greater than two-fold increase in mortality. Needless to say the FDA was not too pleased, so the drug failed to gain approval for that indication.

So the drug company decided to try a less sick population and began the ATHENA Trial. The ATHENA trial was the largest anti-arrhythmic drug trial conducted in patients with non-permanent AF/AFL, involving 4,628 patients with a follow-up of 30 months. In this trial, Multaq, on top of standard cardiovascular therapy, significantly reduced cardiovascular hospitalization or death by 24 percent (p<0.001) when compared to placebo, meeting the study’s primary endpoint. So the FDA granted the drug approval for this indication, provided the patients were carefully screened for heart failure (a contraindication to begin therapy).

All seemed right with the world for Sanolfi, at least for a while. Doctors began using the drug but were generally disappointed in its efficacy despite its hype, being an amiodarone cogener and all. Still, plenty of pressure was applied to the writers of our quidelines to make sure this "highly studied" drug was first and foremost of recommended therapies in the latest atrial fibrillation treatment guidelines. In fact, Multaq® is currently available in 32 countries and is recommended as a first line treatment option in the majority of AF patients by BOTH the ESC and ACC/AHA.

Pretty impressive, given its earlier challenges getting approved.

But now we get the news about the PALLAS trial and we have to wonder: if its unsafe for older, sicker patients, why should it be okay for our younger ones?

We really don't know.

But our antennae certainly are at attention now regarding Multaq. I suspect many doctors will now think long and hard before leaping to dronedarone as their "first line" therapy despite the current recommendations of our "guidelines." More likely, this drug will be used when there are no other options (and there are those cases). Truth be told, most of our pharmachologic therapies to manage atrial fibrillation are problematic for many of our patients for one reason or another: either they have significant side effects or else they just don't work. This is largely why the more invasive atrial fibrillation ablation procedure has gained favor.

But ablation is not a cake-walk either.

That is why the current NIH-co-sponsored CABANA trial comparing catheter ablation to drug therapy as first line therapy remains so important to continue.

Then maybe, just maybe, we can learn which therapy really does benefit our patients best long-term.

-Wes

How to Have Fun Catching Psittacosis

While I don't advise this for everyone, catching a seagull at the beach is sure to provide summertime fun for the whole family:



Heh-

-Wes

Should US Government Research Grants Support Meta-Analyses?

It was another headline busting study this week: Pfizer Drug Tied to Heart Risks - a provocative title no doubt fed to the media from the publisher: the Canadian Medical Association Journal. The study was yet another meta-analysis that culled the world's literature in an attempt to determine if a trend could be found that might implicate Chantix as a causative agent for and increased incidence of heart disease in smokers.

On its surface, the study sounds authoratative, analyzing "14-double-blind randomized controlled trials involving 8216 participants" ranging in duration from "7 to 52 weeks."

Never mind that 57% (25) of adverse events were weighted from one study and that none of the 14 studies had odds ratios that did not cross the unity line.

Despite this, the lead author concluded:

Despite the limitations of our analysis, our findings have potential regulatory and clinical implications.

Sorry, this is not correct. There are no clinical implications of this trial. Like all metanalyses, meta-anaylses simply cannot determine cause and effect. (Note to main stream media: are you folks listening?!?)

That being said, there's another concern I have with studies like this: our deficit and how we're spending our precious research dollars.

This Chantix study's lead author, Sonal Singh, MD MPH, was supported by a grant from the National Center for Research Resources (NCRR), a component of the US National Institutes of Health (NIH) and the NIH Roadmap for Medical Research (grant number 1KL2RR025006-03). This study came from that grant.

But so did meta-analyses on thiazolidinediones and inhaled corticosteroids and their possible risks for leg fractures or heart attacks.

With this grant, here's all you need: pick a drug, any drug. Then go to a computer, do literature searches of other people's work on a particular drug and side effect, then try to find a relationship to something.

That's it. No original ideas. No original hypotheses to test. And all funded by the American taxpayer.

Is this the "roadmap" for medical research that we want for our public scientific dollars?

Certainly we want our researchers to have the freedom to chose an area of research that they feel is important, but when should we insist on some form of accountability for the quality and cost of that research?

-Wes

Addendum: It should be noted that at the time of the above publication, the authors of the above study noted the FDA's announcement of the addition of a warning to the product label for Chantix (varenicline) from the same single 700-patient randomized controlled trial that the authors weighted 57% of their opinion upon, yet the FDA admitted that "the trial was not designed to have statistical power to detect differences between the arms on the safety endpoints."

Disclaimer: I have no financial conflicts of interest to report regarding Chantix or its manufacturer.

European EP Societies Reach Détente

After two years of lengthy discussions, it looks like the Heart Rhythm Society (based in the U.S.) will have a consolidated European competitor counterpart by 2014:

European Heart Rhythm Society-Europace and Cardiostim, Europe's leading congresses in "electrophysiology" and the treatment of heart rhythm disorders (such as atrial fibrillation) have formed a strategic alliance to ensure the development from year to year of a homogeneous congress programme devised under the direction of a common scientific committee.

Historically, the two congresses have alternated the hosting responsibilities for their annual EP meetings: Europace on the odd years and Cardiostim on the even years.

Doctors are glad these colleges will now "provide a scientific continuum from one event to the next."

That's how science works, right? No major breakthroughs to report and doctors (and the public) appropriately shielded from reports of major device complications.

Nice.

I'm glad that the European EP congresses will finally provide a fine-tuned marketing scientific continuum.

-Wes

The Other Side of July

The fourth of July weekend for many Americans means fireworks, family, picnics and barbecues, corn-on-the-cob, and apple pie as we celebrate the anniversary of our country's independence. While many are packing up their bags to head off for a long weekend vacation, former medical students are being filled with anticipation as they begin the craft they've so carefully prepared for: treating real live patients in a real live hospital. How exciting! How terrifying! Like a great action film full of tons of plot shifts and chase scenes - it's an exciting ride. So much so that those of us "older" doctors love to reflect on this time of our careers, even offering tips to the new folks on how to succeed.

But for all the pomp and circumstance of the moment, first year residents are still sheltered and spoon-fed within our academic medical model thanks to work-hour restrictions, training requirements for surgical or medical specialization, and reguirements for licensure and certification of training programs. Slowly and gradually, we see the careful guidance of our newly-minted doctors through training as they are sculpted into tomorrow's American Doctors. Each step is carefully choreographed. Each step funded either by the student themselves or from government subsidies.

But there is another side to July.

While one group of doctors are going into training, another is going out. Doctors stop paying into the education system and start taking: it's the side where doctors' years of delayed gratification suddenly turn into months or years of delayed realization about the job market.

Most used to think it post-training employment was pretty simple: continue as a teacher or researcher of medicine in a familiar academic role or enter a risker (but potentially more lucrative) world of private practice medicine.

But the private practice model is much less certain now.

For young specialty doctors who find a job, they are thrilled. But hospital positions for specialists are less plentiful now as former independent practices are increasingly consolidated by large hospital systems that place their newly-joined specialists on productivity quotas. Who wants to hire when the current market specialists are at larger and larger risk of making less money? Hospitals are the new employers now, not private groups. The market forces have suddenly shifted so hospitalist positions are plentiful and specialty positions less so.

And large education debts for these new doctors are coming due. Those not so lucky to find a local job are realizing they will have to find a job and find it fast. They ask themselves "How will I pay my bills?," "Will I have to move?", "If so, where?"

So their job search net is cast further than they ever imagined. They meet new doctors in new places over dinners promising the world. As a result, decisions are made and contracts signed without a clue about the local patient referral and practice politics in play. You see that information can't be found in a contract. Still, our new doctors are happy to have landed a job even though it's nowhere near the location they had imagined. They try to get situated. Try to make a home. It'll be perfect, really.

For these happy doctors I have one more piece of advice. Please, trust me on this:

Rent, don't buy.

Because it's not that you're a bad guy or gal, it's just that there's a good chance you'll soon be moving again.

-Wes

EKG Du Jour #22: A Cool Case of Fibrillation

... sadly, the EKG is not mine, but rather was published in this week's edition of Circulation:

Click image to enlarge

The story is this: an asymptomatic gentleman with an left ventricular assist device and implanted St. Jude biventricular implantable cardiac defibrilaltor had an episode of syncope and presented to the ER with this EKG.

Some interesting points are made in the discussion section of this case report published in Circulation (sorry, subscription required).

Definitely worth a read (and the link contains the answer).

-Wes

Reference: Zalkind D, Aleong R, Sauer W, Nguyen DT. 'Unusual Fibrillation in the Emergency Department After Fall." Circulation 2011;123;e641-e642.