Firework Safety

One more thing, before I head out. We should probably heed these warnings from the Danish regarding firework safety for New Years.

-Wes

h/t: Instapundit.

Happy New Year!

Here's wishing all of my readers and fellow bloggers a wonderful and safe New Year! I'll be taking a few days traveling to see friends next week, so the blogging will be a bit sporadic. It'll be good to re-charge the blog-brain a bit.

Thanks to all of you for your kind words and support this year. My family and I really appreciate it.

So here's my cyber-toast that goes out to all of you:

"May you live as long as you want to...
... and want to as long as you live!"

To 2008! * glasses clink *

-Wes

Hospital Billing Juggernaut

The New York Times does a good job describing the billing morass that is inpatient care today:

Despite agitated discussions with the billing company to find out what we owed (“We don’t know, we just send you the bills”), and the hospital (“Everything is being processed by your insurance company”) and our insurer (“We are still waiting for the final bills from the hospital”), it took seven months before we got a final bill.

More and more hospitals use outside billing agencies. Every visit or procedure has a different account number (have you ever tried paying these bills with Quicken?) Even if you see the same doctor in follow-up, that visit has a new account number. This is because every bill that goes to Medicare must be independently tracked, so if it is denied, it can be "scrubbed" and resubmitted. This assures the hospital receives its money quickly, but makes it nearly impossible for the patient to know how much has and has not been paid for each their healthcare encounters and procedures. The problems are compounded further by the realization that many doctors are independent contactors working within the hospital's walls with their own bills. It's no wonder patients are confused.

It's an absolute mess.

But with all of the electronics and billing programs and collections agencies out there, somehow we just can't seem to find a solution for the patient. Amazing. Google can compile 3.8 million references to "Hospital bill" in 0.19 seconds, but we still can't get a single hospital bill consolidated in under seven months. Crazy.

I would say that the first hospital that fixes this mess with a patient-centric solution should become America's Top Hospital for 2008. (US News, are you listening?)

But, as we know, it's all just more financial obfuscation and rationing. All in the name of Big Business, so the patient is left to flounder.

Sad, really.

-Wes

Printing Your Own Heart Patch?

I'm not sure how I missed this, but I thought it was pretty cool: printing heart cells in a gel so they self-assemble to create beating heart muscle.

A Missouri professor took several types of chicken heart cells and 3D printed them into large sheets with cell-friendly gel. The cells took over from there, sorting themselves into working order. Then they began beating, just as a heart would.

While it's not ready (at all) for clinical application, it seems there might be a use for this technology supplying working heart cells for pharmaceutical testing.

-Wes

New Heart Failure Monitors on the Horizon

This week, two implantable hemodynamic monitors were revealed that permit continuous real-time pressure measurement of either pulmonary artery or left atrial pressures. It is hoped that the knowledge of this information will improve outpatient management of patients with chronic congestive heart failure.

The first such device reported in Circulation, manufactured by St. Jude Medical, measures the left atrial pressure directly through a transseptal transducer implanted from the leg area. This small pressure sensor is attached to the intraatrial septum (the wall between the two upper chambers of the heart) and is connected to a pacemaker-like device implanted under the skin of the lower abdomen. This device then radios its signal to a hand-held device (that looks remarkably like an old Palm Pilot organizer) that corrects for changes in barometric pressure and displays the pressure recordings. It’s measurements correlated well with Swan Ganz catheter pressure recordings of estimated left atrial pressure.

The second device reported in the Journal of the American College of Cardiology, uses a novel catheter-delivered pressure sensor that is chronically implanted in the pulmonary artery (the same site that harbors the Swan Ganz catheter when it is installed) called the CardioMEMS Heart Failure Sensor (CardioMEMS Inc., Atlanta, Georgia). This device consists of a 3-dimensional coil and a pressure-sensitive capacitor encased within a hermetically sealed, fused silica capsule completely covered in medical-grade silicone. Two wired nitinol (nickle-titanium alloy) loops prevent sensor distal migration in to the pulmonary artery branches. Alterations in the pressure inside of the artery alters the baseline resonant frequency emitted by the device and then, using an external antenna that powers the internal device using electromagnetic coupling non-invasively (i.e., it has no power requirements), the signal is transmitted outside of the body and transduced into a waveform. The external device similarly calibrates for external barometric pressure changes. This device, too, had excellent correlation to Swan Ganz pressure recordings.

Each are fascinating devices, especially for a biomedical engineering geek like myself.

But the most important question to be asked, especially as these devices break through the development hurdles, is will they improve the care we provide patients?

Recent experience with a similar device, the Chronicle implantable hemodynamic monitor (Medtronic, Inc.), failed to gain support from the FDA because the device did not demonstrate an improvement in patient outcomes when their heart failure management was guided by the device’s pressure recordings. It was difficult for physicians to determine from continuous recordings when the threshold for changing therapy was required. Will these newer devices reach a similar fate? Time will tell.

But one thing is certain: if these devices do not affect heart failure management outcomes, there will not be a market for them. This is not to say that our care of heart failure patients might not be enriched in a subgroup of difficult-to-manage patients using these devices: say, those with severe renal insufficiency. But the stakes are high for these companies to determine which patients’ lives might be benefited from their use and to design an appropriate prospective, randomized clinical study to prove the point. Perhaps Dr. Silver said it best in his editorial in JACC:

"...there really are 2 additional "overriding" questions from which we should not be dissuaded. We are always excited to welcome new technology to our diagnostic and potentially therapeutic armamentarium; we need, however, to be aware that such devices herald in a new era where serial recording of the patient in a 'compensated,' 'decompensated,' and every state in between may now be available. We need to sort out how and when to retrieve these signals, how to incorporate them into daily clinical routines and disease management strategies, and how to use information technology to help us decide what signals are the actionable early warning signs of a patient with a forthcoming clinical event. The devices without a suitable infrastructure will overwhelm the doctors and nurses monitoring these devices, and any potential benefit will be obscured by the burden of the data load."

-Wes

References:

Ritzema J, et al. "Direct Left Atrial Pressure Monitoring in Ambulatory Heart Failure Patients Initial Experience With a New Permanent Implantable Device." Circulation 2007;116:2952-2959.

Verdejo HE, et al. "Comparison of a Radiofrequency-Based Wireless Pressure Sensor to Swan-Ganz Catheter and Echocardiography for Ambulatory Assessment of Pulmonary Artery Pressure in Heart Failure." J Am Coll Cardiol, 2007; 50:2375-2382.

Silver MA. "New Approaches to Hemodynamic Measurement: Cool Devices But a Shaky Infrastructure" J Am Coll Cardiol, 2007; 50:2383-2384. (Subscription required)

Politics and Insurance

Want a summary of which candidate's doing what on health care? Here's the simplest summation I've seen in a while.

What's clear: third party insurance interests are uniformly preserved, irrespective of party or candidate.

Real healthcare reform's going to take a bit longer, I guess.

-Wes

CSI - Chicago

He sat at the dinner table, and looked up slowly.

“You know, this time of year, I can’t believe all of the problems I see. Suicides, domestic violence… it starts just after Thanksgiving and continues through New Years.”

The others at the table kept munching on dinner, not really knowing where this was coming from. After all, he was a cop and family member. It was supposed to be a nice Christmas get-together. But we could tell he was bothered by something.

“I mean, there was this mother and daughter. They lived in one of those Habitat-for-Humanity homes. Not a lot of money. People had just brought them a bunch of bags of food. The bags were on the counter in the kitchen. They were good people, trying to make ends meet.”

The feast continued. People slowly took notice, not knowing what to say.

“We got a call. All it said was that a young girl called in a panic saying her mother wasn’t breathing. I was the first one there. I went in the bathroom. I had to shove the door open since she had fallen against it. Her hair dryer was still on. Water was on the floor. My partner got to the bathroom just a second later with the AED, then the ambulance crew arrived with all of their stuff and really worked on her. I spoke with the 12-year old daughter. She seemed to have it together. Such a nice girl. She explained everything so well. They tried like crazy. There was no clue why this young 44-year old woman would end up dead like that. It was such a shame. You think it might have been her heart? I bet she was dead for a while, I mean, her color had settled, you know? Do you think we could have gotten her back?”

He looked at me.

I felt obligated to respond. “It takes only about four minutes without blood to the brain… How long did it take you to get there?"

"Oh, longer than that."

"Do you think she might have been electrocuted? I mean, when I’m in the EP lab trying to induce ventricular fibrillation and every technique fails, I just get out a trusty old 9-volt battery. You know that tingly feeling you experience when you touch those electrodes to your tongue? Well, if that same current is passed inside the heart with a wire, well, nothing fibrillates a heart better. It doesn’t take much current. So, if the floor was wet and her hair dryer was poorly grounded, enough current could have passed through her heart, you know. And people collapse suddenly with no warning when that occurs. Did they test the hair dryer for a current leak?”

"Dad, geeeezzz. Do we have to hear that stuff about 9-volt batteries again?" My kids wanted to discuss anything else, you see.

“No! I’m gonna ask the guys to do that when I get back. I bet you’re right. The guys unplugged that hair-dryer right when they arrived. It was still running when they got there and all…”

He sat quietly, but seemed relieved to have a plausible explanation to his case.

“You gonna be okay?” I asked.

“Yeah, yeah. It goes with the territory. But I never like this time of year. It's never fun, ya know?"

He paused for a moment.

"Now, who's got the gravy?...”

-Wes

Aging on Video

Imagine taking a photograph of yourself very day for eight years, then assembling them all in a single video.

Wonder what it would look like?

Check it out at Kidney Notes.

-Wes

The Ultimate Efficiency

I am constantly amazed at the dizzying heights hospital and insurance bureaucrats will take physicians, all in the name of profit.

In the old days, I could ask my patients questions, take a thorough history and physical, and order tests that made sense to the problem(s) at hand. In short, I could use my brain and patients benefited.

Now, I get paid based on performance. Document the E&M parameters, fill in the necessary blanks, or else. Paint-by-numbers, I called it. Pay for performance became the new Medicare standard creating a heretofore unprecedented bureaucratic morass in 2007. Entire practice patterns were shifted and protocols implemented to maximize Medicare reimbursements for hospitals and physician practices, even if it deleteriously affected the doctor-patient visit. Just ask the questions, dammit, to make sure you get paid the maximum amount and to make sure we look good on hospital rankings!

But that, my friends and colleagues, is not enough. Bureaucrats demand more. Much, much more.

Now, my fellow physicians, we must concern ourselves with efficiency!

And yes, we must create more measures of our efficiency! After all, how else will our "customers" be able to compare us and our "efficiency index?" These business interests (one who also holds an associate editor position at the New England Journal of Medicine in which the discussed editorial aired) hold the precious financial assets, so they will demand it! They want "performance" and "efficiency," all rolled up into one! And if we don't determine our own efficiency measures, well, you can be sure that those lovely "customers" who require our physician services will develop the measures for us! After all, they demand complete and utter efficiency at all times: efficient money collection, efficient returns on their investment, and, in the case of the insurance industry, efficient denial patterns for reimbursements. Efficient, efficient, efficient.

But in the end, isn't the ultimate efficiency less bureaucracy?

-Wes

Reference:
Arnold Milstein, M.D., M.P.H., and Thomas H. Lee, M.D. "Comparing Physicians on Efficiency." N Engl J Med 357:2649-2652.

VT Ablation and the Ankle Swelling Index

I read with interest this week's lead article in the New England Journal of Medicine that evaluated whether prophylactic catheter ablation of ventricular tissue would reduce the incidence of later implantable cardioverter-defibrillator (ICD) shocks called "SMASH-VT:" Substrate Mapping and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia.

"Substrate modification," for those unfamiliar, is a term used by electrophysiologists to change the underlying milleu of the heart to prevent arrhythmias. This is performed by using a three-dimentional mapping system (Biosense-Webster's Carto system was used in this study exclusively) to define where small-amplitude (i.e, less than 1.5 mV in amplitude and implicitely thought to be abnormal) electrogram signals were detected within the heart. These areas were labeled as "scar" within the interior of the heart. By ablating, or burning, areas within the scar, it is hoped to disrupt the potentially life-threatening reentrant circuits that cause the abnormal heart rhythms that cause ICDs to fire. Many ablation lesions are used to create the "lines" that disrupt these circuits.

But the process of determining where to ablate in these cases is laborious and time-consuming. First, not all ablation was performed in sinus rhythm, as the pseudonym of the trial would suggest. The authors did try to induce ventricular tachycardia in the patients, and even tried to have rapid arrhythmias slowed with a class Ic antiarrhythmic to define the predominant clinical ventricular arrhythmia to target. Adding to the complexity of the studies performed, fully 74 percent of the patients underwent both a transseptal (crossing a catheter from the right to the left atrium to access the left ventricle) and simultaneous retrograde aortic approach (reaching the left ventricle by passing the ablation catheter up the femoral artery backward through the aortic valve and into the left ventricle).

It is an impressive tour d' force to perform these procedures. All in the name of reducing ICD shocks in the patient with an indwelling ICD and a history of ventricular tachycardia. Electrophysiologists reading this study know this.

So I found it interesting that I could not estimate my own Ankle Swelling Index (ASI) accurately from this study. That's the index of how large my ankles will become after standing at the patient's bedside to perform this procedure. A one-hour procedure gives an Ankle Swelling Index of 1, a two-hour procedure gives an ASI of 2, and so on. You see the reason I could not estimate this accurately is because no ablation times or radiation exposure times were mentioned in this study. Why? Were they excessive?

Instead, I must estimate. So given the complexity of the ablation procedure described in this study, I estimate the procedure times for each of each of these patients to exceed four hours each: an ASI greater than 4. And I would not be surprised if several indexes were over 5.

Man. That's huge.

It's huge because, like it or not, to ever apply prophylactic ventricular ablation to prevent ICD shocks in a patient who has already received (or will receive) an ICD, the time spent for both the patient and the doctor has to be worth the risks involved in long procedures. The complexities of this ablation approach, while shown to be feasible and safe (at least in this small group of carefully-selected patients), it was by no means without risk (three of the ablation patients had some complications). Further, not reporting the time required to implement this approach has serious implications for recommending the type of anesthesia and estimating whether these patients with limited ventricular function can lie recumbent long enough to undergo the procedure.

So while there appears to be a role for substrate-based catheter ablation to prevent ICD shocks, careful evaluation for the Ankle Swelling Index as well as the risks inherent to the ablation approach used in this sick patient population should be considered carefully before applying this approach to every patient receiving an ICD for the indiction of ventricular tachycardia or ventricular fibrillation.

-Wes

References:

Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. "Prophylactic Catheter Ablation for the Prevention of Defibrillator Therapy." N Engl J Med Dec 27, 2007: 357(26): 2657-2665.

Editorial: Estes NAM. "Ablation after ICD Implantation — Bridging the Gap between Promise and Practice." N Engl J Med Dec 27, 2007; 357(26): 2717-2719.

Ectopia Cordis

Shanghaiist.com provides a rare glimpse by video of what appears to be a case of thoracoabdominal ectopia cordis (the heart covered only with a thin layer of skin) in a young girl from China.

-Wes

Consumer Healthcare 2008

In case haven't heard, I was just e-mailed this exciting opportunity to purchase Consumer Healthcare 2008, which contains a whole host of exciting marketing strategy opportunities to manipulate the patient, er, healthcare consumer, for the low, low price of just 308.00 euros ($446.63 US dollars):

Consumer Healthcare 2008 is designed for hospital marketing executives and strategic planners. It includes insight into consumers health-related behaviors and characteristics, how they obtain health information, their decisionmaking relating to seeking treatment and selecting a provider, and the influence of marketing on the choices they make.

Using the behavioral analysis and segmentation guidelines in Consumer Healthcare 2008, hospitals can fine-tune marketing, better focus on specific patient demographics, address patient expectations, and, ultimately, improve patient satisfaction.

Not to mention, their bottom line.

Imagine, you can read about the Cancer "Market" outlook or the US Diet "Market" outlook with all of their profit potentials for 2008!

So don't be late! Get your copy today!

After all, there's still time to cut back on the number of healthcare providers like nurses and doctors to assure healthy profit margins in the upcoming year!

-Wes

The Pathophysiology of Insurance

I guess I must have missed something in medical school.

I studied biology and human physiology and microbiology and pharmacology and pathology.

I thought I learned a lot about how a heart attack happens. You know: the “vulnerable plaque,” the “lipid core,” “good cholesterol,” “bad cholesterol,” the “sudden thrombosis” that occurs to obstruct blood flow to a portion of the heart muscle. I realized there was still a lot we didn’t know about how to prevent heart attacks, but smoking cessation, diet and weight loss, beta blockers, “statin” drugs and the like all were integral to help prevent them.

What I never learned was that insurance, especially Medicare insurance, was likely the missing link in the prevention of heart attacks.

Who knew?

Imagine. Universal healthcare insurance has now been irrefutably associated with a reduction in heart attacks.

Thousands of people say so. After all, they completed surveys and are convinced, and I mean, convinced, that they are healthier because of insurance. After all, they’ve seen all the “wellness” ads on television. They’ve seen the smiling faces of those people that seem so happy taking Viagra and playing their guitars. They’ve seen the peaceful Lunesta butterfly flitting across the beds of some beautiful people resting comfortably knowing that fitful sleep is just a mere $142 per month away. They've seen the AARP-endorsed "SecureHorizons" advertisements with smiling seniors feeling so fortunate to have insurance (never mind that AARP receives over 60% of its fees by way of "royalties" from the insurance industry).

So fantastic is insurance at heart attack prevention that the researchers of this important trial never even had to consult a single health record to verify their claims. Not one. From the studies "limitations" section:

"Our study relied on self-reported health measures rather than data from medical records. Although our measure of adverse cardiovascular outcomes summarized related items selected for their face validity, this scale has not been formally evaluated as a measure of cardiovascular disease severity."

Case closed.

I mean, it’s compelling, eh?

And yet it makes more splashy press releases about reducing heart attacks, sponsored in part by the Commonwealth Fund, just in time for the important upcoming election.

Made even splashier when it comes from Brigham and Women's Hospital, Harvard Medical School, the Department of Health Care Policy, the National Bureau of Economic Research and the Department of Health Policy and Management, Harvard School of Public Health, all based in the state that already can’t figure out how to pay for their affordable "universal” insurance: Massachusetts.

And the same plan whose oversight board has approved cuts of 3% to 5% in reimbursements for to health-care providers caring for those in the subsidized plan to balance the budget shortfall.

But maybe these researchers are on to something.

I wonder what the future tax burdens and co-pays for the people of Massachusetts might do to their future incidence of heart attacks? Or what the incidence of heart attacks will be in the physicians from that state soon?

I bet I could find out.

I'll just ask 'em.

-Wes

Image credit.

Merry Christmas

For the greeters at the front door,

For the kitchen staff,

For the transporters and maintenance workers,

For the security staff,

For the volunteers who visited the hospital today, and who visit tomorrow,

For the medical students and residents who drew the short straw,

For the secretaries, librarians, and clerical staff,

For the laboratory and xray technicians,

For the chaplains and social workers and engineers and groundskeepers,

For the administrators and directors,

For the nurses who go the extra mile,

For the doctors who cover this night, and yes,

For the patients too sick to be able to be with their families tonight:

From our home to yours,

May the peace and joy of this holiday season brighten your day and give you comfort.

Merry Christmas to all!

-Wes

Remembering

It all started with "the call."

And then the surgery. You poor guy, you lost your toe. And although it was tough to get around, we secretly schemed to get you a scooter.

Later, you would wrestle with the challenges of considering dialysis.

Even when you were in the hospital, we had a chance to reminisce about earlier times. That was so great to stop, reflect, share. And I'll never forget that day I came in to see you in the hospital to find you had won the turkey bowling championship! Damn that was funny!

Later, I'd kick myself for not recognizing your heart failure. You became weaker and your hands told the story as you continued to wrestle with the decision for dialysis. You finally went through with it, but you never felt better. You stayed weak, immobile, dependent on others to get to dialysis. It made you crazy. We talked again, and I suggested another option: to stop. You agreed.

Now our whole philosophy shifted. From trying to cure you, to trying to care for you. We knew the outcome, but you were miserable.

I looked for things to ease your mind and let you escape, if for a bit, from the everyday world of illness: I played guitar for you. You smiled. Later I would write the story, tears in my eyes. God, it was hard.

Your condition grew more grave. Mom got concerned. I ran to the house to find you resting in your chair watching that stupid show, remember? You looked so exhausted then.

Some days later, things got to the point where you just wanted to die, but couldn't. We thought you might die that night. Mom read us a story from a clipping she had saved for all of these years, one heard by many. We found it hard to believe the dates in the story were so close. As though He had a plan all along. Amazing.

But the next morning you awoke and asked, "I'm not dead yet? Damn it!" We laughed nervously. You were so frustrated and your breathing was much more labored. Against the wishes of others, I called the priest. He arrived about 10 AM and you seemed glad to see him. You cordially said, "I think your timing's just about right." He played a soft song and said a prayer. Your eyes closed. Your hands became flaccid as I watched the subtle fasciculations beneath your skin. We never heard from you again.

Later that night, about 5 PM, you touched down, making your last landing here on earth. I watched your face turn white as you sat in your mechanical geri-chair, and knew you were at peace. At last. I was relieved.

That night I went home and tried to sleep. I remember stopping at a stop light as I drove home and easing my foot off the brake so the car would gently glide to a stop, rather than jerk. You taught me that. Tears welled up as I thought about that moment many years before when you were helping me learn how to drive.

Later that night it rained like crazy. You used to love thunderstorms. Loud claps of thunder rattled by bedroom, and I remembered smiling and thinking you were buzzing the tower one last time while rocking those wings to and fro, just to say goodbye. Sleep came easy.

Now I look at my living room. A tree stands proudly in the window, glowing with multi-colored lights that lend a warmth to the remainder of the room. The dog sleeps quietly on the couch. The kids are excited yet again and life moves forward much too fast.

In this brief moment of silence tonight I couldn't help but reflect on this past year. Although it was tough while we were in the trenches, I was glad we could spend that time together. I wouldn't have traded it for the world.

Merry Christmas, Dad.

-Wes

Faulty Marquis Defibrillator? Here's $35K

We now can estimate what one device failure costs device companies per patient: $35,645.04. And throw in $18.5 million to be distributed amongst the lawyers who worked so hard on behalf of the nearly 2,682 patients.

Medtronic has agreed to pay $114 million to settle the liability claims against it but states the settlement does not mean it admits liability or the validity of any defenses in the litigation.

Interesting.

This is probably an important little "oh-by-the-way" as the Supreme Court decides the issue of whether device manufacturers are liable at the state level after the feds (a la the FDA) have approved such a device.

The Marquis battery recall occurred when the process of such recalls was in its infancy: doctors, ever ready to "protect their patients" removed the devices because of concerns the device could short-out and fail abruptly, leaving their patients without backup pacing or the ability to shock their arrhythmias. After replacing many of the devices, it later became apparent that there might be a downside to this approach: a small but real number of patients experienced an infection from the follow-up surgical procedure. Devices, leads and all, then had to be removed. It was a mess. So a more cautious approach was later advised: have the patient check their device with a magnet to listen for an "all's clear" tone each day. It was a pain in the rump for the patient, but it avoided the risk of infection. Doctors got smarter. Call it a learning curve.

And so, with the more recent Sprint Fidelis recall, we saw a more conservative approach - watch and wait. It remains to be seen if this is the right approach, but given our earlier experience, it might be more prudent.

And maybe just accepting that such recalls will cost the device companies about $35K per patient to settle.

Let's see: 235,000 active Sprint Fiedelis patients x $35K?

About $8.4 billion.

On second thought...

-Wes

My Plan B

If things get too bad from the Medicare cuts, I think I just found my Plan B...

-Wes

Commitment

A wonderful piece by our own Dr. Russell Robertson appeared in our local paper yesterday, and it's definitely worth a read regarding helping our fellow man this and every holiday season:

There are many opportunities to tangentially serve in ways that may be legitimately helpful but ultimately brief and may leave the servant feeling better than the served.

While I would happily endorse any and all forms of contribution, I would more heartily endorse a sustained commitment and one that supports an existing organization with a strongly developed presence. The self-enforced requirement to re-visit distressed persons or locales is sure to keep one both aware of the plight of others and to maintain a healthy sense of the injustices to which so many of our fellow human beings are subject. This can be especially useful for adolescents so long as they are prepared for what they might experience and not put in harm's way.

This is one to think hard about...

-Wes

"My Doctor" Becomes "The Doctor"

Happy's going to be happy today.

My fellow blogger, Happy Hospitalist, who has added more to our understanding of the economics of our health care crisis than many others after his blog appeared this year, gets to toot his horn a bit more. After all, hospitalists had yet another retrospective, observational study released today in the mighty New England Journal of Medicine that justifies the subspecialty economically.

So it's official: hospitals like hospitalists. And hospitalists like hospitals. Yep, it's a "WIN-WIN" as Happy likes to say.

Now I don't have the time to go into all of the limitations of the study design as reported, but some of the fanciest statistics in the world were used to overcome the admitted limitations of the trial. This certainly didn't thwart the editors and peer reviewers in the Journal from publishing this work - after all there were lots and lots of data. (*Sigh*) But if were to naively accept the results of the study, the bottom line from the authors' analysis suggested that hospitalists save about $268 dollars (less than the cost of a single echocardiogram) and shave off about half a day of hospital time compared to what an general internist or family practitioner could muster without a change in hospital mortality.

Now, don't get me wrong, I think that hospitalists are here to stay. They offer lots of advantages to patients, being omni-present in the hospital and all. But there are some things that our embattled primary care physicians and patients will lose a bit more of because of this economic inevitability: their doctor-patient relationship. Patients no longer are cared for by "my doctor," but rather "the doctor."

And that doctor changes often.

You see, the hospitalist movement requires the "handoff" of the patient from the "primary care" physician to the hospitalist when they enter the hospital. And once in the hospital (what the authors failed to mention), is that at least weekly, and usually nightly, another hospitalist assumes that patient's care. A whole set of re-learning occurs. As though the patient is moving down an industrial assembly line with a different machine applying a few more welds to the final body part.

So patients are left to wonder who, exactly, is their doctor this week or this evening while in the hospital. Whom do they call to find out the results of a test? Whom do they call to discuss an upcoming therapy? Will their (outpatient) doctor have a say in the decisions of day to day care? (Sorry, not really.)

The economics for the field of primary care will also be affected. More and more primary care physicians find they can't compete economically with the salaries of hospitalists. After all, hospitalists have to pay little to no overhead, except their malpractice which is often subsidized by their hospital employer. Additionally, hospitalists' are often incentivised to minimize length of stay with additional bonuses too.

Which leads to the question, where does that extra money paid to hospitalists come from?

A primary care doctor in the outside world must rely on the old economics of the broken Medicare reimbursement system that feeds them mainly a declining "professional" fee for an outpatient office visit. They cannot refer to their own x-ray facility or lab facility due to the Stark II self-referral law that bans such practices. The hospitalists, however, enjoy a slight competetive edge with their income supplied by the omnipotent hospitals who can collect the much larger Medicare "technical" fees from the many procedures ordered by hospitalists and use these funds to support their slightly higher salaries. These incentives are effectively a legal loophole that skirts the well-known Stark II self-referral law. All perfectly legal: after all, they're just "employees" on salary receiving "productivity" bonuses.

So, the primary care doctors are losing a bit more control over their patients and a bit more revenue erosion relative to their hospitalist peers. Patients meanwhile are seeing slightly shorter hospital stays and a more attentive physician presence in the hospital, but are left not knowing who's managing their care.

It's a strange new world of medicine these days - all in the name of efficiency and economics.

-Wes

Rationing the Spin

The insurance industry wants to be sure everyone has insurance coverage:

“We are taking responsibility for ensuring that no one falls through the cracks,” said Karen Ignagni, the chief executive of the trade group, America’s Health Insurance Plans, which is based in Washington.

But here's what they're doing - rationing again:

While the group is proposing that the states cover the most costly individuals, private insurers would offer policies to everyone else. “We are providing essentially a coverage safety net,” she said.

Boloney.

Show me the money.

Show me what "coverage" you propose. What's the deductible? What's the limit on insurability? What, cat got your tongue?

It is far from certain whether any of the specific proposals will be enacted or states will finance the cost of broader coverage. But the industry’s position indicates a willingness to move toward a system in which everyone can find coverage.

Why does the New York Times report these PR pieces without reporting the real data? It gives people the wrong impression.

Insurance companies are financial companies bent on profit, not healthcare providers. Period. This "initiative" is a smokescreen for enrolling more paying customers while tacitly assuring the insurance industry's profits by covertly rationing care in the name of their purported "beneficence."

-Wes

Jalife to Join University of Michigan

Jose Jalife, MD, a skilled researcher in the basic science of the electrophysiology of atrial fibrillation, will be leaving his long-time home at the State University of New York (SUNY) for the University of Michigan, Ann Arbor. His basic science work (and research grants) will compliment the clinical work of Fred Morady, MD, who is already based there.

-Wes

Senate Votes to Delay Physician Medicare Cuts

The Senate approved a proposal for a brief reprieve to the proposed 10.1% physician fee cuts for 6 months. The bill moves to the House today.

It seems the Senators and Congressmen might recognize the political fallout they'll suffer if their constituency can't get their healthcare when they bask in unfettered care themselves.

-Wes

Med Schools Fail at the Business of Medicine

I have the pleasure each year of interviewing some of the brighest individuals applying to our categorical and transitional medicine residency programs. So far, I have asked each of 9 interview candidates to answer this question at the end of their interview:

"What do the numbers 99233 or 99244 mean to you?"

Without exception, each of them sat dazed.

Then I asked them, "What's the difference between an ICD-9 code and a CPT code?"

"It has something to do with billing," most said but not one knew the difference between the two.

Is this acceptable? Is it responsible to leave our medical students so woefully unprepared to enter the big wide world of medicine as it exists today?

Each of the students got an "A" for their efforts and idealism, but the programs from which they came received an "F" in teaching the business of medicine.

-Wes

Image reference.

CT Scan as Good as V/Q for Pulmonary Embolus

An important trial will appears in the Journal of the American Medical Association (JAMA) of a prospective randomized trial comparing CT pulmonary angiography (CTPA) to V/Q (ventillation/perfusion) scans to exclude pulmonary embolus. CT scans were not found to be inferior to V/Q scans at detecting pulmonary emboli and were actually found to be more sensitive at detecting emboli. The authors concluded that further research would be required to determine whether all pulmonary emboli detected by CTPA should be managed with anticoagulant therapy.

Given the speed and convenience of CT scanners coupled with avoidance of receiving "indeterminant" V/Q scan results, CT scans are likely to preempt V/Q scans in the diagnosis of pulmonary embolus in many patients (with the exception of patients with renal insufficiency in whom iodinated contrast agents might prove dangerous).

-Wes

Our Most Popular Shirt for 2007

Our pink "Cancer Picked the Wrong Diva" shirt was the most popular at Medtees.com this year. There's still two days left to receive this one (or any others) for friends or family in time for Christmas.

-Wes

Merry Christmas, Navy Style

For the holidays, it doesn't get much better than this:

Laura Montero, 14, fell ill aboard the Dawn Princess cruise ship off the coast of Baja California.

The Bahamian-registered ship sent out a distress call Friday that was answered by the USS Ronald Reagan, which was on training maneuvers about 500 miles away.

The nuclear carrier was the closest ship with a hospital facility, according to a news release from the Navy. It steamed overnight toward the cruise ship, which was about 250 miles northwest of Cabo San Lucas when the call went out.

A helicopter took off from the Reagan around 5 a.m. Saturday to close the final 175-mile gap between the ships. The crew arrived after a 45-minute flight and lowered a medic onto the cruise ship deck in a basket because there wasn't space to land, said Lt. Cmdr. Gregory Leland, the pilot.

Montero, who was on an antibiotic drip, was loaded into a litter basket, lifted into the helicopter and flown back to the Reagan for an appendectomy. Her mother stayed aboard the cruise ship.

A big "bravo zulu" for a job well done.

-Wes

07:50AM CST: A bit more on Laura and her mother, Trudy.

How to Avoid Christmas Tree Syncope

Down another 20 ornaments this year...

Never, ever, hang too many heavy ornaments on one side of the tree or, like what happened to us last year, you might experience Christmas Tree Syncope.

-Wes

Santa's Preventative Maintenance

Might we be going a bit too far?

"My first concern is whether he could be developing the metabolic syndrome because of his truncal obesity, but he's had a good long life. He might be one of these people who are fit and fat," Dr. Applegate said. "But I wonder whether he might have lung disease like emphysema or COPD.I would want to check his lung function to make sure that coal dust and coming down chimneys is not a problem for him."

What would you recommend for Santa? A colonoscopy? PSA? Lipid panel? CT Calcium Scoring? Stress echo? Framingham Risk Scores? Low fat diet? Aspirin every day? Smoking cessation program? Yoga? Reiki?

I'd say, give the guy a break. He's got a big day ahead of him.

-Wes

2007 Medical Weblog Awards

Nominations are up over at Medgadget, with some good nominees so far.

-Wes

The Concertos

"Why on earth do we try to do all this each year when we know it's going to be so crazy?"

"Honey, I really didn't think your son's holiday concert followed by a little dinner party would kill you."

"But I have to get there an hour before the concert just to find a seat, for goodness sake."

"Take the Tribune, get comfortable, and reserve me a seat. Now, go!"

So off I went. My sixth year in a row of the high school's annual holiday concert. But this high school has four thousand students, and forty-five thousand parents and grandparents and brothers and sisters and aunts and uncles that all have to arrive at least an hour before the concert to clammor for a seat. Holiday cheer goes out the window in such circumstances. Bah humbug.

My wife, bless her soul, having placed the finishing touches on the dinner preparations before attending, arrived five minutes before the concert and experienced the same shock and awe that I had when she saw the crowds.

But all was forgiven when the music started. It was quite a show.

At least until my beeper went off.

"Call the ICU STAT," it read. Two seconds later: "Code Blue, ICU."

I looked at my wife. Her eyes rolled as she whispered, "Go." I grabbed by coat and quietly slipped out of the concert hall and ran to the car, calling as I went.

"That lady's heart stopped again. No clue why. We had to use the external pacer to get her back."

"I'll be there in 10 minutes."

After setting new land speed records through a construction zone on the way to the hospital I arrived to find her attached to a ventillator, hair beautifully maintained, husband and teenage daughter at her side. A daughter not much younger than my son. Standing tall, unwaivering, but clearly concerned for her mother, trying to keep it together.

"It'll take me just a few minutes," I explained after reviewing the details of placing a temporary pacing wire. The nurses, meanwhile, had assembled the necessary instruments and drapes; a well-rehearsed concert they carry out many times each week.

As I worked, it became eerily silent, and I looked up to see her pupils dilate as she stared blankly toward the ceiling, her arm reflexly bending skyward with uncanny strength for the few muscles remaining on her bones. She was unresponsive and the monitor showed delightful P waves dancing across the screen, while the more important R waves were on holiday.

"Uh, mind turning on the temp pacing pads for a bit?" I asked, as calmly as possible. Her chest began to twitch as she slowly regained conciousness and I felt a pulse again, this time bounding vigorously due to the catecholamine surge that accompanies such moments.

The needle entered the vein on the first pass.

"It's okay, Mrs. Smith. We'll have that wire in place in no time." And like our own miniature concerto, with the soloist at the forefront of the stage and the nurses acting like the orchestra behind, the semifloating pacing wire advanced to the heart and started a new cadence that was all our own. R waves danced again on the screen. The audience roared.

Well, not really.

But it was our concert. My patient and me. However brief. Never heard, but appreciated.

Just like my son's concert.

-Wes

Physician Profiling

It's official. Doctors are being discriminated against.

We're being profiled.

By our own AMA.

Buffalo (NY) physician Nancy Nielsen of the AMA, worked with New York Attorney General Andrew Cuomo to develop the model to profile doctors.

But in a remarkable display of double-speak, we find:

"The AMA commends Independent Health for voluntarily joining the ongoing shift in the health insurance industry's stance on physician profiling," Nielsen said. "Although Independent Health does not profile physicians, its agreement with the Attorney General indicates that a primary commitment to quality improvement already exists within the company."

Wow.

So the AMA commends Independent Health for joining the physician profiling although Independent Health does not profile doctors.

And the AMA commends them for this behavior.

From the Wall Street Journal:

Over the next year, the rankings will become more transparent and thorough under agreements reached in recent months between several of the biggest health insurers and New York Attorney General Andrew Cuomo. Aetna, Cigna, UnitedHealthcare and WellPoint have said they'll apply the agreed-upon approach to their ratings nationwide.

The insurers have agreed to rate quality as well as cost and to use independently accepted criteria -- which might include, for example, measures from the not-for-profit National Committee for Quality Assurance -- instead of just claims data to rate physicians. They also will adjust for risk so that, for example, a doctor is not
penalized for handling more complex cases that may result in higher costs and more
deaths.

Additionally, doctors will be able to review the data and appeal the decisions.

Now I touched on this before, but since it now seems that the National Committee for Quality Assurance (NCQA) from Washington DC "might" be developing the ranking criteria, I thought I would see who will be doing this important task.

Here are some of the positions the NCQA needs filled right now (according to their website). I've included my comments about each one in italics:

Assistant Director
The Assistant Director (Focus on Health Promotions & Disease Management) will manage and coordinate measure and program development and implementation activities (e.g. MAP/ expert panel meetings), including establishing goals and strategies and generating new ideas.

In other words, this person has no idea what he's to do, but "wellness" strategies and removing sick people from the insurance rosters will help future rationing strategies for healthcare.

Assistant Vice President, Product Development
The Assistant Vice President will provide NCQA leadership in California with its large number of NCQA customers and significant managed care market; to do so by working with a variety of organizations to make NCQA evaluation tools relevant to them; and to identify business opportunities for NCQA and be responsible for carrying them out This involves establishing California relationships; understanding the environment in California, understanding NCQA products and capabilities and directing California-based and headquarters-based NCQA resources.

California doctors, you're screwed. It seems your managed care market is particularly perplexing since the "environment" is less than tasteful to "organizations" like insurers and government. Therefore, doctors will be really ranked there. Oh, and what "relationships" are they talking about that need to get "established," any way? Glad I work in Illinois.

Chief Information Officer
The Chief Information Officer (CIO) is responsible for providing data & technology vision, and strategic direction, for developing and implementing information technology (IT) initiatives and information products that support NCQA's mission. The major purpose for this role is to lead the creation of a significant data strategy, which will support performance measurement within the health care system.

You see, the data strategy still needs some work. And the data systems to update the voluminous quality data points aren't ready quite yet, so the updates to the ranking websites will not be in real-time. That will take the hire of ten more IT specialists to implement. Estimated date of completion: 2062.

Manager, Data Collections
The Data Collections Manager will oversee and manage HEDIS data submission operations and staffing (3+ staff positions), including non-survey HEDIS data and survey HEDIS data (CAHPS, HOS, etc.).

There are never enough people to measure the data. Never mind they have no idea what it all means. Rest assured the data, however, will be transparent as they'll publish it quickly.

Manager, Information Products
The Manager, Information Products will lead day-to-day management of Health Plan Report Card redesign project, including planning, analysis, testing, implementation, and training for immediate and longer term development phases.

Once they have the data, they plan to sell it as their "product," I guess.

Policy Analyst
The Policy Analyst will analyze questions, research content; prepare accurate written responses to questions for customers and for discussion at internal meetings and serve as an internal resource to organizations.

Hmm. Which "organizations" exactly will this person serve as a resource to? Doesn't sound like they're a resource to patients. Could it be the insurance agencies? CMS?

Policy Analyst (HEDIS)
The Policy Analyst (HEDIS) prepares standard written responses to customers through the Policy Clarification Support system. This person serves as an internal resource to organization.

Everyone needs, wants, and understands a "Policy Clarification Support" system that explains what all the verbiage means and supports other organizations like the insurance industry.

Policy Manager
The Policy Manager will serve as product and content experts for assigned accreditation and certification products. This person will provide direct support and clarification on complex questions regarding Standards and Guidelines and associated HEDIS measures.

So much policy, so little time. A "Manager" is certainly needed here, especially for all those "Standards and Guidelines!"

Senior Health Care Analyst
The Senior Health Care Analyst will establish goals and strategy; manage and coordinate measure development process in assigned areas, including prioritization of measures and issues, assessment of measures, and development of specifications; develop pilot testing strategy and implementation of measures.

What are these guys goals and strategy? I thought they were ranking doctors. How hard can this be? I mean "prioritization of measures and issues?" You mean, not all measures are created equal? How are the measures "prioritized," by coin toss?

Senior Health Care Analyst (Focus on RRU & CMS)
The Senior Health Care Analyst will establish goals and strategy; manage and coordinate measure development process in assigned areas, including prioritization of measures and issues, assessment of measures, and development of specifications; develop pilot testing strategy and implementation of measures.

Just like the last guy, only more, since he reports to our Government.

VP, Product Development
The Vice President is responsible for leading the product Development Department in execution of opportunities or organization growth, while keeping NCQA in the forefront of the quality movement in health care. He/she will have primary responsibility for evolving NCQA evaluation products to advance our mission.

In other words, the sales of the quality assurance "Product" will assure the maintenance of the NCQA's remarkable budget and bureaucracy.

Incredible display, eh? So many people hell-bent on physician profiling and "transparency."

All supported by the AMA in concert with the insurance industry.

But in the end, Even the AMA's own believe we'd be better off ignoring the rankings and listening to friends and nurses:

But "at the end of the day most of us rely on friends, family and word of mouth" to choose a doctor, says Alwyn Cassil, a spokeswoman for the Center for Studying Health System Change, a research group in Washington. She recommends asking a trusted pediatrician, internist or family physician for a referral to a specialist. If you don't have a doctor, ask friends and family for recommendations.

Hospital nurses also are a great resource. "They know who is nice, and they know who is good," says Dr. Nielsen of the AMA.

Funny how the nurses never seemed to mention Dr. Nielsen.

-Wes

Regulating Away Healthcare

It's become a sisyphean nightmare.

Endless reguirements for documentation to get paid, defending one's actions so the patient will get paid, justifying one's actions so the hospital will get paid, while covering your ass so you won't get sued. All while trying to take care of patients.

We are left to wonder, where has healthcare gone?

The answer is simple: it's gone the way of the bureaucrats.

It's gone the way of quality assurance.

It's gone the way of intolerance to error.

It's gone the way of patient satisfaction surveys.

It's gone the way of sterility, MRSA screens, hand sanitizers and no white coats.

It's gone the way of efficiency and cost-effectiveness: to electronic medical records that use voluminous electronic plagiarism to get the maximum Medicare allotment of money for the least possible work while doing nothing to improve the actual management of a patient. (Being a slave to the inpatient world, I don't know how I'd survive without this now).

And now, it's going the way of guidelines on top of guidelines. You see it wasn't enough to have guidelines for management of acute coronary syndrome, or non-Q wave myocardial infarction, or management of heart failure. Now we will soon have guidelines directing us to which coronary stent we should use. Mandated by the very FDA who is paid by the device companies to review their products. The same FDA that will charge $43,190 to review a single direct-to-consumer ad, plus a one-time operating reserve fee of $82,780, because they have to pay 27 additional staff members to assist with those reviews.

Bureaucracy on top of bureaucracy.

All done to feed more bureaucracy, not to really effect healthcare delivery.

It's no wonder the healthcare industry is the second most regulated industry behind the nuclear power industry.

I searched for AHA (American Heart Association) Scientific Statements and found 16,442 such statements on everything from heart attacks in the elderly, to dietary recommendations, heart attack care, arrhythmias, evaluations of athletes, and much more. It is an impressive array of statements and recommendations. But these "statements" and guidelines have become so commonplace, that their usefulness has waned.

Except to lawyers who say, "See, I told you so. Now you have to pay!"

Or regulators who say, "You idiot! I told you not to do that!"

And insurance companies bent on denials: "See, we don't pay for that under those circumstances."

Fortunately, I know plenty of doctors who listen to and speak with their patients. They've stopped seeing people in 7 minutes. They see them in 15-, or 30-, or 60-minute appointments. They don't miss things because they take their time, are thorough and follow-up with the referring physician or family. They work patiently, yet efficiently and never say no to a consult. Even on the same day. And their practices are thriving.

No voice recording on the phone. Real people who respond to your needs.

No bureaucracy.

They're entrepreneurial. Risk takers. Organized.

And they don't take insurance. Ever. But they'll help you get reimbursed, if you so choose.

This is the wave of the future, and slowly, gradually, things will change.

For the better.

Now I just have to figure out what us specialists will have to do to survive...

-Wes

Image credit.

More on Medtronic's Sprint Fidelis Lead

... recall appears in the New York Times today.

The issue regarding replacing these leads in pacemaker-dependent patients is raised in the article. This is a tough decision. It is clear that some are recommending extraction of leads in this case and at first blush, this might be appropriate. But the risk of introducing an infection anytime a pocket is opened remains. This risk is about 1%, even in experienced centers. Is the risk of replacement worth this? We have little data to know at this time. Unfortunately, we do not know if the incidence of lead fracture stays constant, increases, or decreases with time. This is important information and will only come as additional follow-up of these leads is forthcoming. If the risk of fracture is greatest in the first few months after implant, and then tapers off, perhaps NOT replacing a more chronic lead will become the more advisable approach. If it increases with time, then extraction might be worth the risk.

What is certain right now, is that none of us has the right answer - so patients should have a thorough discussion with their doctors about all of the pros and cons about lead extraction. Believe me, lead extraction is not always as easy as the Spectranetics company (with their video that accompanies the NYT article) would suggest.

-Wes

Newer Long-Term Cardiac Monitors

Today, Medtronic announced FDA approval of two implantable event recorders called the Reveal DX and Reveal XT, extentions of the earlier Reveal Plus implantable loop recorders (pictured). The Reveal DX continuously monitors the heart rhythm for up to three years, an extention of the Reveal Plus's approximately 14-month longevity, and adds additional heart rate monitoring zones classified as ventricular tachycardia or fast ventricular tachycardia zones. Information is "interrogated" via a specialized, proprietary Medtronic programmer. When patients have symptoms, they can use a hand-held device held over the Reveal implant site to "lock in" the event in the device's memory. (Other earlier-generation devices are discussed in a previous post).

The Reveal XT, monitors for atrial fibrillation episodes, too, but will not be first to market (unfortunately).

Each of the Reveal family of devices requires a minor surgical procedure for implantation that is typically performed as an outpatient procedure under local anesthesia. They have historically cost about $4000-6,000 each.

Medtronic's Reveal platform faces competition from Cardionet, a later-stage, non-invasive cardiac monitoring system dedicated to the detection of syncope and arrhythmic burden that requires no surgery.

With Cardionet, a special monitoring lead system sends the patient's heart rhythm via a bluetooth connection to a dedicated cellphone worn on the patient's waistband that transmits the patient's heart rhythm via cellphone to a central monitoring station (video available here). With the Cardionet system, patient's heart rhythms are monitored 24/7 and using physician-specified criteria, doctors are notified if a dangerous arrhythmia occurs without the need for patient notification. Each arrhythmia as well as heart rate and variability trends are upload to a web-based database system that can easily be evaluated by the physician on any standard computer using a secure internet connection.

In our clinical experience, the Cardionet system has detected asystole (no heart rhythm) while the patient was "sleeping" but noted to be "shaking in bed" by their spouse. The biggest problem for cardiologists prescribing these devices are the late nite calls: I was recently contacted at 2:30 AM for a four-beat run of ventricular tachycardia that terminated spontaneously after having just fallen asleep 30 minutes earlier from another (unrelated) call. Fortunately, I was able to reset the criteria for notifying the physician after speaking with the monitoring technician.

Cardionet's limitation is that it can only be used for up to 21 consecutive days. Each day of monitoring is billed separately to insurance carriers as needed. So if the dysrhythmia occurs infrequently (i.e., more than every three weeks) then longer-term monitoring, like Medtronic's Reveal platform, should be employed.

-Wes

Havin' a Ball With Cholesterol

There's lots of news today on lipid-lowering drugs:

First, Merck is asking the FDA for the third time to permit lovastatin (Mevacor), the first HMG-CoA reductase inhibitor (or "statin"), to be sold over the counter. It seems twice is not enough. It's like telling a child "no" but they keep coming back, "Really, Daddy?" No! "Pretty please, daddy?" Not only no, but hell no!

So Merck is saying "pretty please?" and feels patients can understand a package insert like the one they use in Spain that says:

"Due to the inclusion of butylhydroxyanisol as excipient this may produce irritation of eyes, skin and mucous membranes."

Do they really think Americans will read this stuff? Ask yourself, do men read assembly instructions for a new kitchen appliance or ask for directions when lost? Of course not! Why would we read some stupid package insert from an over-the-counter medication? Does anyone read an acetaminophen (Tylenol) package insert? "Marge, just give me those damn pills!"

But seriously, the drug interactions with lovastatin alone are significant. Lovastatin is metabolized in the liver, and interacts with anticoagulants and antiarrhythmic drugs like Amiodarone, and can cause some rip-roaring myositis (inflammation of the muscles) in patients who might be taking other cholesterol-lowering medications like niacin or fibrates.

And heck, with simvastatin (formerly Zocor) available for $4 for 30 pills at Walmart by prescription and is likely cheaper, do Americans really need this?

Worse still, doctors have enough problems tracking prescribed medications on their patients. Will we really know what medications a patient is taking when all of these other medications want to be circulated over the counter?

Speaking of Zocor...

What's up with Merck and Schering-Plough withholding their results of the ENHANCE trial that compares, head to head, the combination drug Vytorin (simvastatin + ezetimibe) to simvastatin or placebo? This morning the WSJ Health Blog reports that the US House of Representatives Energy and Commerce Committee and Subcommittee on Oversight and Investigations is concerned "with the delay in releasing the results of the study, the timing of the ENHANCE trial registration (on ClinicalTrials.gov), and the apparent manipulation of trial data." (Letter here).

Since when has our Congress cared so much about scientific endeavors such as this? I mean, this is one of tons of other cholesterol trials out there. Are they really interested in the delay or could there be another political motive? Could it be because Michigan Democrat Bart Stupak was left off Schering-Plough's political donation list when Rep. John Dingell got $5000 or because Merck left Michigan off its contribution list entirely in 2006? Is Congress now suddenly interested if drug companies might be massaging their data just to get the results they want? Or have the Democratic House members been raising these questions because they just shorted Merck and Schering-Plough's stock?

I guess we'll have to wait for the March ACC meeting to find out.

-Wes

Addendum 13 Dec 2007 19:50 CST: Three strikes, they're out. The FDA rejects Merck's bid.

Entitlement

Click to enlarge.

I heard about this ad from the California Nurses Association they purchased. They use Dick Cheney as a centerpiece for what's wrong with the Medicare system today. The ad begins "The patient’s history and prognosis were grim: four heart attacks, quadruple bypass surgery, angioplasty, an implanted defibrillator and now an emergency procedure to treat an irregular heartbeat."

It seems our California nurses feel that patients (especially Vice Presidential patients) can predict their heart attacks occur and determine their care when it is rendered. They assume that if this happened to anyone else, "they'd be dead."

Nothing could be further from the truth.

But it does not make for sensationalist ads. Instead, they want House Resolution 676 supported by our presidential candidates, arguing for "Medicare for all" as the answer to our healthcare crisis. As if it were free. No holes barred. Pay for everything. Nothing but the best. Expand our governmental bureaucracy to included every man, woman, and child, with complete medical, dental, vision, and long-term care. Hell, throw in a Rolls Royce for your driveway, too!

As if it's all free. You can have ANYTHING! Yee-hah! We're ENTITLED! Just like the Vice President!

Don't look at how we got where we are. Nope. Just more of the same, ONLY BIGGER!

Frickin' brilliant.

-Wes

Memorabilia

"Kb" left an interesting question about her husband on an earlier post:

"hubby had a heart transplant earlier this year and wants his ICD device back to keep. (editors note: I assumed he wanted it back when his device was due to be changed due to a low battery condition.) I can't understand this. Do you know why someone would want that back??? It's like keeping your tonsils in jar."

To which I answered:

There are lots of reasons why people would want to keep their defibrillator, just as people want to keep souvenirs.

For many, having an ICD requires courage and trust. Once in a while, someone's life is saved by one. Many, many patients grow attached to their device since, for a while, it was part of "them."
And then there's the curiosity part: what does it look like? is it heavy? , etc. (Most patients don't see it before it's implanted).

And don't forget that it costs a pretty penny, too.

So for lots of reasons, many folks want to have their device after it's explanted. I would suggest he return it, (so the company can do their quality assurance), but then ask that it be returned to him. (They'll usually do this).

After all, he paid for it (likely via insurance).

But there was one other thing I forgot to mention as to why it's good to send off those defibrillators to the manufacturers: Sometime's there's residual battery life on them, so the manufacturer disconnects the capacitors and renders them incapable of inadvertantly shocking you as you try to stick a fork in the high voltage terminal of the device "just to see what would happen."

Not that I have ever heard of anyone doing this, mind you.

-Wes

Post Number 1001

I looked at my blog postings and realized that, today, this post is number 1001 since I started this gig over 2 years ago.

I'm not sure if that's a good thing or bad thing... but a day of rest might be in order.

-Wes

What Kind of Doc Are You?

Aggravated Doc Surg with the cartoon characteristics.

-Wes

The Pacemaker Turns 50

On the creation of the first cardiac pacemaker:

If the power went out, back in the 1940s and 1950s, the loss of electricity could be profound. And that's just what happened one day, back in 1957. A huge power outage hit Minnesota and Wisconsin, and a giant electrical pacemaker quit working. It had been keeping a young child alive. That little boy died.

In exasperation, the child's doctor said to Bakken, can't you come up with something that doesn't require electricity to help keep these kids alive?

Bakken got to work. He found a diagram of a metronome, something that keeps the beat in music, and he turned it into the world's first, battery-powered pacemaker. He tried it on a dog and it worked. Within days, doctors put that same device on another child. Bakken just happened to run into that little boy at the hospital. He says that moment changed his life.

Too bad medical innovation can't occur that quickly any longer.

-Wes

The Ultimate Double Bubble

This is the CXR of my toughest single chamber pacemaker cases, ever. (Used with patient permission).

It demonstrates massive right and left atrial enlargement from severe, longstanding mitral and tricuspid insufficiency. It also nicely demonstrates the "double-bubble" sign, with the right atrium outlined but the pacemaker lead descending down the margin of the right atrium from the superior vena cava, and the left atrial free wall nearly touching her right chest wall.

The patient was nearly 96 years old and collapsed while in her bathroom, striking her head and causing an asymptomatic subarachnoid hemorrhage while on coumadin for long-standing atrial fibrillation. She was found to have a regular junctional escape rhythm at 35-40 and was on no rate-slowing medications. Her lead dislodged six times during the case as it was forcefully ejected from the right ventricle. Fortunately, this morning she was doing well with great pacing thresholds.

Massive left atrial enlargement was also described by Ortner in the setting of mitral stenosis where the left atrium was so large that it compressed the recurrent laryngeal nerve as it passed beneath the tracheal bifurcation, giving rise to Ortner's Syndrome.

Ah, just another day at the office...

-Wes

Opening a Can of Worms

The Wall Street Journal reported this morning that a doctor was fired for a financial conflict of interest at the Cleveland Clinic, and now that doctor has countersued (subscription required):

Dr. Yadav was dismissed for allegedly not complying with the clinic's conflict of interest policies. His lawsuit, filed yesterday in Ohio state court, says he was being scapegoated.

* * *
His suit alleges the clinic has been "indifferent" to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos "Toby" Cosgrove, according to the complaint.

The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring.

The clinic confirmed Dr. Cosgrove and the hospital share royalties, but declined to answer questions about what patients are told and how much the institution and Dr. Cosgrove earn from sales of the ring. The clinic said the royalty payments were proper.

Many major medical centers have such arrangements, I'm sure. Senior physicians at top institutions got there because they were either incredibly busy and productive clinically, or they had remarkable revenue streams from research - a la, intellectual property rights.

Now, research can be performed overtly, or it can be performed covertly. Overtly is okay in the eyes of the law, provided it is appropriately vetted by an institutional review board and patients sign informed consent. Covertly performed research without the patient's knowledge is illegal, obviously. But if the use of certain clincally-approved devices occurs that directly compensates physicians without the patient's knowledge to the exclusion of all other similar technologies or without the patient's knowledge, does that mean that there's a significant financial conflict of interest? Perhaps. Especially if exclusive hospital purchasing contracts exist with a particular medical device vendor.

This suit has just opened a can of worms - for doctors and hospitals - and stands to change the terrain of hospital-based purchasing agreements and royalty payment disclosures.

Maybe that's a good thing.

-Wes

0.5 percent

...that's what Mr. William McGuire's fine to the SEC was for his stock option backdating scandal relative to the estimated value of those stock options (estimated to be worth $1.4 billion dollars).

Poor Mr. Mcguire. He also had to "forfeit" (mind you, he never was "paid" anything, but rather had an "option," potentially, to cash in on the money) $620 million back to Unitedhealth's board in an agreement not to be sued by their shareholders.

And he gets to "exercise" (i.e., get paid) $800 million because he was such a nice guy as to give up 43.7% of his potential haul.

PLUS, he spends no time in jail.

I hope this isn't too tough on him. I mean, after all, he was such a nice guy to so many peoples' portfolios.

But patients ultimately paid the price for this mess, you know: through denied claims and by having to change doctors as health care "plans" were reorganized to assure Unitedhealth's profits as they gobbled up competitors through shrewd business practices that obfuscated and delayed payments to physicians and their patients.

This, my friends, is the real healthcare crisis story in a nutshell. Sugar-coating healthcare as "wellness" in hopes of stealing from the poor to feed the rich, all in the name of profitting investors.

Now in the time of our election, we must look for change, but there's one small problem:

Traditionally, the financial sector — banks, insurance companies, and the real estate industry — has been the largest source of funds for presidential and congressional races, followed by lawyers and lobbyists and then ideological and single-issue groups, according to the Center for Responsive Politics.

So do we think things will change substantially?

Of course not.

After all, the government is still gloating over their 0.5 percent fine to Mr. Mcguire.

-Wes

0800 AM CST Addendum: My original post claimed it was 0.000005% earlier this AM - I had not had my coffee yet. The correct percentage amount was calculated as: $7,000,000 / $1,400,000,000 x 100% = 0.5% for Mr. Mcguire's fine paid to the SEC. I regret my earlier miscalculation.

Privacy vs. Security

"Trust me, I know what's good for you."

When I hear those words, trust is the last thing that comes to mind. I think of wiley deception, one-uppance, playing me for a fool.

So what do you think, when a press release announces "Hitrust" - the Health Information Trust Alliance, an industry consortium comprised by huge business interests in the healthcare arena who have singularly and consistently desired to obfuscate transparency of healthcare costs: CVS Caremark, Highmark Inc., Hospital Corporation of America, Humana, Johnson & Johnson, Philips Healthcare, and Pitney Bowes? Do you think "security" when these companies collectively employ thousands and thousands of people who have access to your health information?

In a dazzling display of bureaucracy, we learned yesterday of this consortium's desire to "Build Greater Trust in the Electronic Flow of Information Through the Healthcare System" and spend tons of your money doing it.

Thanks. We need this. I feel so much better now, knowing that my health care information is "flowing" around cyberspace at the speed of light "securely" to insurers who want to deny my claims for healthcare. I feel so much better that a direct mail provider (Pitney Bowes) can target my "needs" more accurately and send my "mailstream" to even more prying eyes with profit motives to their shareholders in the name of "efficiency." I feel so good that hospitals can now more securely apply even more bill-padding to my hospital bill with even less transparency than before. And I particularly am happy that "privacy" will be separated from "security," as though these providers have relinguished their responsibility to my privacy in such a publically disseminated manner:

"Although 'privacy' and 'security' are often used interchangeably, they are distinct, but interrelated, concepts," said Kimberly Gray, Chief Privacy Officer, Highmark Inc. "Health information privacy in the U.S. today focuses on keeping personal information confidential, and privacy policy is generally overseen by government and regulatory bodies. Security, on the other hand, is the means and mechanisms to protect privacy and must be capable of quickly adapting to changes in the technology and industry landscape and is best left to the private sector. HITRUST is singularly focused on the latter."

You see? Privacy is not their responsibility.

So go ahead: trust me.

(Yeah, right.)

-Wes

Coffee and Heart Attacks

Now this is important news.

-Wes

"It's Deplorable"

More criticism of the Cypher stent ad campaign appears in the New York Times.

Such an initiative is so pernicious and wasteful (can you say, "expensive?") at a time when doctors and patients are being squeezed by corporate interests over healthcare delivery that I hope this ad becomes a battle cry to steer patient's away from their device.

Why do you think Medtronic quietly buried their direct-to-consumer ad campaign? (Hint: It wasn't just because of lead recalls. Referring doctors, seeing the avaricious nature of such a campaign, revolted as well.)

-Wes

Adrenalin Rush

What happens to your heart rate when you skydive? It's pretty impressive:

I purchased a heart rate monitor and tested it out on a very intense skydive. a RAFT DIVE. You can see my heart rate skyrocket during freefall.

Now you can see what my heart rate did when during the ~24 minute ride in the plane up. It was pretty consistent at about 130 bmp which is still pretty freakin high. Look at it shoot waaaay up during our 1 minute freefall. 240 bpm???

Yep.

But then again, I wonder if he has SVT?

-Wes

Supreme Court to Hear Medical Device Case Today

In a case that is sure to have broad implications for the medical device industry, Medtronic will stand before the Supreme Court today to argue that the federal device approval process absolves them of product liability when cases are presented through state law claims after one of their devices is used off-label. Specifically:

Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.

The lawsuit, Riegel v. Medtronic, was brought by the Donna Riegel, whose husband, Charles, was injured in 1996 when a Medtronic Evergreen balloon angioplasty catheter burst after being over-inflated and left Mr. Riegel injured and disabled. He later died of brain cancer:

(CNNMoney.com) The Riegels sued Medtronic in 2002, but lost in a New York federal district court and then on appeal. The two courts, siding with Medtronic, ruled that a 1976 amendment to the federal Food, Drug and Cosmetic Act protects medical device makers from being sued.

"The defendant says you can't sue us in state or federal court because it's pre-empted by the federal amendment from 1976," said Wayne P. Smith, a lawyer for Riegel. "It's a very devastating defense."

***
Medtronic spokesman Robert Clark said his company will ask the Supreme Court to uphold the appeals court decision ruling against Riegel. Clark said that doctor malpractice, not device malfunction, caused the catheter to rupture because it was inflated beyond its FDA-approved limits.

"The product did not malfunction," said Clark. "The physician used the product in a manner that was outside its label and its intention. In this case, it was expanded beyond the labeled indication."

This case has important implications that extend beyond just the device industry. With the FDA now being asked to regulate everything from food products, over-the-counter advertising, drugs, and medical devices, a ruling in Medtronic's favor might become a large legal defense barrier for all sorts of manufacturers.

-Wes