Saturday, September 29, 2007

Natale Out at Cleveland Clinic

Troubling news on the atrial fibrillation ablation front from the Cleveland Clinic today:
One of the Cleveland Clinic's high-ranking cardiologists and a pioneer in the treatment of a specific electrical heart problem has been let go.

Dr. Andrea Natale has been medical director for the Clinic's two-year-old Center for Atrial Fibrillation, a top moneymaker for the hospital system. Atrial fibrillation is an irregular heartbeat that is the leading cause of stroke.

Clinic spokeswoman Eileen Sheil said the Clinic decided Friday not to renew his appointment, which expires Sunday. She declined to say why the Clinic is allowing Natale's contract to lapse, calling it a personnel matter, which is private.
But later in the article, the authors opine:
In the past, he has done procedures outside of Ohio without the Clinic's permission, hospital sources said.
But is this a reason to let someone go? Doubtful. Surely something else was afoot here, but just as surely, I doubt we'll discover what it was.

-Wes

Addendum:
2 Oct 2007 - Natale responds on his website.
More from Cleveland's The Plain Dealer.

A New Hazard of CT Scanning

Being forgotten:
A cancer patient says she was left alone in a CT scanner for hours after a technician apparently forget about her, and she finally crawled out of the device, only to find herself locked in the closed clinic.
Has CT scanning become so routine that we forget that there are people involved?

-Wes

Cubs Clinch

It doesn't happen often here in Chicago, but baby, you're lookin' at one happy town.

Go Cubs!

-Wes

Photo Credit: Chicago Tribune

Addendum: The Tribune's videos of the Cub's history is worth a look.

Friday, September 28, 2007

The Next Huge Challenge

The next time you're in a large amphitheater with quite a few folks, try asking this unsolicited yet provocative request:

"Raise your hand if you are going to die."

Usually about one third of the people raise their hand, but the remainder sheepishly acknowledge that they really didn't want to think about it and hesitate.

But as we all know, we all will die. And before death comes aging late in life. One senior at my father's assisted living facility commented: "Getting old ain't for sissies."

But many of our population are living longer than ever.

It's great to that we're keeping older folks alive longer, isn't it?

Well, maybe.

Our next big challenge will be caring for the chronic health needs of the over-85 crowd. In England, they have noticed a record number of centenarians:
Dr Lorna Layward, from Help the Aged, said: "It's hard to know whether these extra years are providing extra years of good health.

"Hopefully, with better medical provision, these extra years can be happy and healthy."

Emma Soames, the editor of Saga Magazine, said: "The government has got to get its act together, because the care services in this country are really not fit for purpose at the moment.

"We have a whole generation in their 50s and 60s who are looking after elderly relatives."

Gordon Lishman, director general of Age Concern, said: "Demographic change presents a number of opportunities and challenges to public services and public spending.

"For example, most people living in care homes are over the age of 85. As the number of people over the age of 90 increases, so will the need for care home spaces.

"All too often we are failing to respond adequately to the changing demographic challenge facing the UK."
The US is in a similar predicament. I have been struck by the increasing number of 90 and 100-year olds I find on the hospital wards on the weekends. Which leads to the next important question.

With the current market pressures, will we have enough doctors to tend to these seniors? The yearly threats to shrink physician Medicare reimbursements by the Centers for Medicare & Medicaid Services (a.k.a. CMS) as they continue to follow Congressional guidelines intended to slow the rise of health-care costs leaves many a physician with little incentive to continue with the current rat race. After all, after expenses, some have estimated the average annual primary care physician earns about $80,000 per year - less take-home pay than many nurse practitioners.

To amplify staffing concerns, physician recruitment and retention has recently become a global issue. An Indian colleague of mine has commented that many foreign medical physicians who immigrated to the US to find profitable jobs are now moving back to their home countries. Why? Because technology in even remote towns has met or exceeded that of the US and the economics of their health care systems are far more lucrative for them. This, then, leaves many US hospitals and training programs woefully understaffed for many primary care specialties like internal medicine or family medicine. While some would counter that internal medicine training programs should increase the number of trainees, program directors are keenly aware that training extra doctors diminishes the collective bargaining power of current physicians as they struggle to thwart ongoing salary concessions mandated by Congress.

So what to do?

First, it goes without saying that Congress should avoid further Medicare cuts for physician reimbursement - after all, who will take care of them if they approve these cuts? But the outcome of negotiations is never certain. So we wait on the sidelines.

Secondly, civic and community leaders should look at their strategic plans and consider options to facilitate aging-at-home initiatives. What are communities providing in terms of transporation, home meals, distaster preparedness, and even financial planning assistance? Adequacy of assisted living facilities, nursing home facilites and staffing requirements should be carefully considered now as our seniors continue to age.

Finally, economic incentives for physicians to enter these much-needed fields of gerontology and internal medicine would go a long way to securing the health of all of our aging senior population.

-Wes

Image credit.

The $20-million-dollar Heart?

That's what Sotheby's wants for this 9-foot heart.

And to think we can't get enough money to purchase defibrillators for our first-responders.

-Wes

With Cigarettes: Men Suck

My job is secure.

I was awestruck by a Center for Disease Control (CDC) report yesterday that demonstrated that, on average, one of five people over the age of 18 still smoke.

More importantly, the prevalence (at least in Illinois) is even higher for younger adults ages 18-35: one in four. And we're not talking about just casual smokers who later quit. No, we're talking about people who have already smoked over 100 cigarettes in their lifetime and say they currently smoke every day or some days. If true, these data are remarkably concerning and mean that we've got a lot to learn about how to implement public health policy on a grass roots level. It also speaks to how little the recent $200 billion tobacco settlement did for protecting our youth.

But then came the next remarkable statistic from this data that missed the headlines: men sucked more (on cigarettes, that is).

Without exception, the prevelence of men smoking exceeded that of women in every state. Why was this? Does testosterone combined with nictotine have a differential addictive effect? Or are we just more gullible to the influence of advertisers? Or is it because men don't seek health care as often as women and hence aren't reminded as often about the adverse effects of smoking? Who knows, maybe this is the reason guys have a consistently shorter longevity than gals.

Or is it because men are less educated than women? Fewer and fewer men are entering college now, relative to women. The educational system in America, with its unchecked growth in costs (especially in colleges) stays clear of this issue because it's not politically correct. And college admissions officers have admitted that acceptance standards are lower for men than women. But even from pre-college days, an increasing population of male children are failing to excel in grade school and high school relative to women. It's as though the old ways of teaching with bland coarse curriculae and drum-beat learning exercises has failed in comparison to the draws of action-packed video games (like the record-breaking Halo 3) that suck time from the active pursuit of learning and fail to engage our young men and boys. Many a child (mine included) have fettered away ridiculous amounts of time on these games to find themselves coming up short on tomorrow's exam.

This is not to blame the video game industry for the demise of male education in America. The problem is much more deep-seated than that. Attracting male educators to serve as role models to our education system is rarely discussed, but the need is keen, especially in early childhood education. Reworking our curriculae to stay in touch with the ever-rapid expansion of information and information delivery while "un-plugging" our families from the incessant influx of media influences might help too.

Certainly, I am not a specialist in education, but an educator and a guy who thinks about health. And there is a clear connection between the quality (and quantity) of education and the influence of public health initiatives - like smoking cessation - and we we'll never fix one problem without fixing them both.

-Wes

Wednesday, September 26, 2007

Pseudosmoking

Just when you think you've seen it all, comes "digital smoking."

What new schemes to take your money will they think of next?

-Wes

Improving Heart Health in Chicago

Heh.

-Wes

Sermo Questioned

Although others have commented before on Sermo and the AMA, Medgadget and Enoch Choi raise some must-read concerns to the discussion of this online "physicians-only" forum.

Given the push for doctors' life histories to be made available to the public, it seems doctor imposters might also include people from the pharmaeutical and medical device industries.

Yuck.

-Wes

11:35 AM CST - Update (h/t KevinMD): Medgadget's Open Letter to Sermo's CEO.

Revolution Bankrupsy

If one wants to see the connection between money and healthcare, one only needs to look so far as Revolution.com. Founded by Steve Case (of AOL fame), it hosts a cadre of services including Revolution Health, Revolution Living and an even a financial arm with a new credit card provider, Revolution Money.

Revolution Health is basically a front for RediClinic that offers basic health services in a retail setting, and ExtendBenefits and ConnectYourCare, which provide “coverage-related products and services” (aka, insurance policies) to people and businesses. Revolution Living includes luxury resorts and wooing spas called Miraval – I guess to help with your “wellness.”

But imagine a credit card with 35.5% interest. This might be your interest rate if your credit history isn’t so great and you decide to sign up for Steve’s virtual credit card called Revolution Money. Revolution Money is exciting to merchants because it lowers their transaction fees to as low as 0.5% compared to the 1.5-8% charge of the more traditional charge cards. It is also exciting because your name and account number are not contained on the card making it, as they say, “more secure.” It seems you just make up a PIN number, show them your entire financial and personal information (including driver's license) and voila' – you’re in the money!

But in an almost identical mirror to the insurance industry, Revolution Money has shifted the costs to the consumer through exorbitantly high interest rates tied to the consumer’s credit rating and payment history. Interest rates can vary between 7.99 to 29.50% - but fail to miss two consecutive minimum payments or be late on payments four times in a year, see those interest rates balloon to between 13.99% and 35.50%. And imagine trying to reconcile an evaporating charge from your checking account when it’s not even tied to an identifiable account number. Does this sound anything like the beginnings of the current subprime mortgage financial crisis to anyone else besides me?

It is ironic that we see his money product line so closely tied to his health product - what better way to pay for your health care costs? Talk about "empowering the healthcare consumer!" Pay, baby, pay!

Unfortunately, credit card debt sinks many young financial savings plans before they can get started and the thought of this card being used for high medical costs is scary indeed, especially for our most “at-risk” population financially and medically. But what’s scariest of all?

It’ll probably sell like hotcakes.

-Wes

Tuesday, September 25, 2007

Mark Your Calendar

30 September 2007:

Journée mondiale du coeur
Wereld-Hartdag
Welt Herztag
La Giornata Mondiale del Cuore
Światowy Dzień Serca
Dia Mundial do Coração
Mеждународный день сердца
Día Mundial del Corazón
World Heart Day

-Wes

Christmas in September

This morning, I walked downstairs and every light in the house was on at 6:00AM. Standing proudly at the foot of the stairs was my son in this shirt, beaming brightly, "Dad, it was AWESOME. The graphics were soooo cool. And I beat it in four hours! Dude, a ten hour game in four hours!

What can I say? Microsoft's Halo 3 was a hit and sure made for some animated conversation with my son at a time when I almost never see him awake.

-Wes

Oh, and the shirt? We put up the design on our Cicada Store website.

Grand Rounds is Up

Medical blogger's 4th year of blogging Grand Rounds kicks off its fourth year at Kevin MD.

-Wes

Monday, September 24, 2007

Illness vs. Wellness

What is "wellness?"

I could not find a reference to the word "wellness" before 1995. (It is interesting that this correlates to the time when managed care took hold in medicine.) Could this word have been born of pure marketing fluff? It is described as a noun on Dictionary.com. We used to speak of one's "well-being," or "fitness" maybe, but not "wellness." After all, we don't say "I have wellness," do we?

I hear everyone using this word now, but I'm not sure any of us really knows what it means. Most people tell me it's the opposite of "illness," but is it really? Wikipedia suggests it's "a balance of mind, body and spirit" which implies one can be very ill and still have wellness. Others have noted that it's really a pet food.

If one looks closely at how "wellness" is used by some insurers, we see a very different definition (and I suspect motive) for the word. Could it be that insurers have concocted these programs to save their skins in the eyes of the gullible consumers by providing a "feel good" aire to themselves while reaping ridiculous profits and making our patients pay increasingly more of their own health care costs? After all, insurers should be about insuring illness, not providing healthcare in "wellness" clinics.

Take for instance, the wellness initiatives from UnitedHealth. We find that "wellness" means they want to store your health information online through an online database called a "Personal Health Manager". Any shread of evidence this promotes "wellness (whatever that is)?" Nope. Or how about well "wellness" endeavors of a "Healthy Pregnancy Program." Are insurers making housecalls in these programs? Or just calling the house? Where are their performance measures? I mean, doctors have to supply our performance measures to insurers - why can't we see the effects of the insurers' "wellness" measures? Could it be that "wellness" is intangible (and therefore non-existent)?

Public health initiatives like smoking cessation is also commonly promoted in "wellness" clinics. To be fair, smoking bans appear to have had a huge impact on the health of societies worldwide. But while insurers offer some tips on smoking cessation to many of their members, their efforts fall flat compared to the efforts of grass-roots organizations enacting legislation. And now, nicotine blood levels are being used to discriminate between insurance rates for smokers and non-smokers. Where's the "wellness" love here?

And then comes “health screenings” by "wellness" initiatives. Mammograms. Glucose and cholesterol levels. Colonoscopies. But do these really prevent disease, or provide “early detection” of disease for the insurer? You see, early detection helps insurers know who’s going to be “naughty and nice” regarding costs to their system - it's another way to weed out "high risk" members of your insured population under the guise of "wellness." What happens when insurers find you have coronary disease or hyperlipidemia? Your premiums rise. In the case of mammograms and colonoscopies, early detection with these tests certainly can save lives – but importantly, it does nothing to prevent disease. Many of these maladies are genetically predetermined. The public dissembling by insurers when they encourage people to “live a healthy lifestyle” is ludicrous. People still socialize, people still drink, people still drive, people still age, people are fallible, and yes, despite such smoke-screens, people get sick, and people still need someone to provide insurance when they're ill, not when they have "wellness."

But when studies and procedures are needed for people who are sick, it has almost become the norm for insurers to deny payment to doctors for at least some services required for their management. The sad fact is insurers' denials have become so commonplace, that now a new layer of bureaucracy has come to our collections industry - companies to help doctors collect the claims that are denied by insurers. Making doctors and hospitals jump through administrative hoops has become the de facto standard of care in the healthcare industry today. One only needs to look to the much ballyhooed IPO of AthenaHealth this week – a company who initial stock price shot up 97% on Wall Street on its first day - and a company who develops web-based software to facilitate physician collections. It reminds me of the $435 hammers that the military was purchasing years ago. Too much bureaucracy, too much overhead. Unfortunately, when doctors don't receive payment from insurers, guess who gets billed? The patient.

That really promotes patients' psychological well-being (not "wellness") doesn't it?

I'd suggest from now on, that the noun "Wellness" be left to the dogs.

-Wes

Health Discrimination is Here

"Sorry, Mrs. Smith, while we appreciate your excellent attendance and work ethic here at Clarian Health, it's come to our attention that you're fat, so we want you to submit to a blood test to measure your cholesterol. If you refuse, you're fired. If your cholesterol is high, you're going to pay more for our insurance."

"What's that you say? Drawing your blood without your permission is assault? I think you're mistaken, Mr. Smith. Our company policy requires this test be taken because we're a hospital group and we know what's best for you."

"You have what? What are you talking about Mrs. Smith? We don't see Cushings Syndrome or diabetes on our exclusion list. You're just fat, young lady, and we know that fat people are high risk for our insurer so suck it up."

"You want us to speak to whom? The ACLU? Who are they? Oh, you mean those guys. We're really not worried, Mrs. Smith about them, honey. You see Mrs. Smith, those guys need insurance and I hear they're all fat, too."

-Wes

Saturday, September 22, 2007

What the Future Holds With Government-Run Healthcare

Just look to Canada:
Tumilty said some of his own patients due to receive hip or knee replacements have been waiting more than 12 months for the surgery.

"They're suffering in pain for over a year," he said. "Their quality of life is diminished considerably and that's just not good enough," he said.

Tumilty said voters — and politicians — should be aware that turnover of physicians is already a serious issue.

About 25 per cent of physicians have indicated retirement plans for the next five to 10 years, he said.
Sounds great, eh?

-Wes

Why Doctors Should Sue Their Patients

“Maybe doctors could get the Democrats to like them if they started suing their patients.”
-Ann Coulter


Imagine the possibilities:

A patient gets sick at 2AM, and a call to the physician's home deprives him of much-needed sleep, causing him to have a car accident as he drives to the hospital – clearly the patient should get sick during regular business hours.

A physician spills hot coffee on himself and suffers second-degree burns as he tries to stay awake treating the ill patient – clearly it was the patient’s fault.

A patient develops renal insufficiency while taking either an ACE inhibitor or an angiotensin receptor blocker (ARB), thereby destroying the physician’s perfect record of providing appropriate therapy for left ventricular systolic dysfunction thereby negatively affecting his PQRI Measurement Score - leading to lost revenues.

A doctor inserts an emergency intravenous catheter into a car crash victim and the woman dies. Because the doctor was one of a number of physicians named in a medical malpractice suit alleging that he should have "appreciate[d] the signs and symptoms of hypovolemic shock and internal bleeding" and that he should have "surgically repair[ed] the bleeding" be must now list the filing anytime he applies for medical liability insurance for the rest of his career - how much damage is that?
* * *

If this seems repugnant to you, consider how adverse the climate is for doctors facing these exposures every day. Even for the best doctors and the best hospitals, aspects of healthcare are an inherently unpredictable, uncontrollable enterprise.

If it seems absurd to insert the legal profession into defending doctors, perhaps it is equally absurd to invite the legal profession into any aspect of the doctor-patient relationship.

-Wes

h/t: KevinMD.

Art and Medicine

"Adenosine"

Perhaps my favorite drug in medicine, Adenosine, lasts only seconds in the bloodstream to correct many supraventricular tachycardias. Now, the art piece by the same name by Damien Hirst is on sale at Sotheby's for a cool $3,609,828 - $5,013,650.

Stare at the work for a while to see if it behaves the same way.

-Wes

Image credit: Wall Street Journal.

Blogger Pushes Design for Diabetics

Please join me in offering congratulations to fellow-blogger and diabetic Amy Tenderich (author of the blog Diabetes Mine) for her piece in Business Week that outlines her efforts at improving glucose monitoring device design:
But large medical-device makers aren't the only companies paying attention to the market. Adaptive Path, a San Francisco user-experience design strategy consultancy best known for its Web-design work for companies including Intel (INTC), Crayola, and Wells Fargo (WFC), recently created a concept for a diabetes device called Charmr, which looks like a necklace charm. The concept was inspired by an open letter written by diabetic Amy Tenderich (author of the site Diabetes Mine) to Apple Chief Executive Steve Jobs.

"Most of these [diabetes] devices are clunky, make weird alarm sounds, are more or less hard to use, and burn quickly through batteries," wrote Tenderich. "In other words: their design doesn't hold a candle to the iPod." She called for Jobs to sponsor medical-device design contests, to enlist Apple design head Jonathan Ive to remake the contest winners into feasible products, and to fund an Apple medical design school. To date, Tenderich says Jobs has not responded to her letter.

Worthy Concept
After reading Tenderich's post, a group from Adaptive Path decided to respond; they applied their experience at designing user interfaces to creating a concept for a diabetes-management tool that might have the consumer appeal of an iPod. Their goal was not only to challenge themselves as designers but also to work on a humanitarian product to which they could apply their knowledge of user-centric interface design. "The language of the Web and the digital are moving into the physical," says Dan Saffer, an interaction designer at Adaptive Path who worked on the Charmr project. Saffer and his colleagues wanted to see if they could apply Web-style navigation elements and intuitive graphics to a medical device.

So this past summer the team spent nine weeks designing a two-part device consisting of a wearable pump and a controller that can be plugged into a flash drive to upload a diabetic's health data and transmit it to a caregiver. While Charmr exists only as computer renderings and in a faux-promotional video that's circulating on the Web, the idea, Saffer says, was to prompt other designers, consumer-electronics companies, and medical-device manufacturers to develop more user-friendly diabetes-tool designs.
Well done, Amy.

-Wes

Friday, September 21, 2007

A Master of EKG Education Dies

On August 31, 2007, world-renowned cardiologist Dr. Henry "Barney" Marriott passed away. Marriott, 90, was best remembered for contributions to the field of ECG interpretation. I remember watching as hoards of people strained to watch the master at work, interpreting the mechanisms of arrhythmias by the findings on EKG and remarkable intuition.

He will be sorely missed.

According to theHeart.org:
The Marriott Heart Foundation is planning a memorial service in Chicago at the ACC to celebrate his life, and any photos, books, memorabilia, or letters that can be shared at this event can be passed along to Dr. Jonni Cooper-Marriott at jcooper17@tampabay.rr.com.
I'd encourage anyone with memorabilia to contribute.

-Wes

Lost in Transition

Mrs. Jones was an older woman, distinguished, bright, forthright, but burdened by an intermittent rapid heart rhythm. When I saw her, she was careful to inquire about the risks, benefits, and alternatives to catheter ablation versus medical therapy for her arrhythmia. She was reluctant to proceed with the more invasive therapy, but didn’t really like the prospect of life-long drug therapy either. She sought a second opinion, and returned, deciding that the risk of the procedure outweighed the prospect of drugs, and she liked the prospect of having her procedure closer to home.

The day of her procedure was like any other. Her intravenous line had already been installed as she presented to the cath lab holding area. We reviewed the potential risks and benefits again with her husband at her side again. We covered everything. Bleeding, infection, damage to the heart and blood vessels, need for a repeat procedure due to a small risk of recurrence, etc. She was prepped with EKG stickers, defibrillator pads and antiseptic solution, and kissed her husband as we wheeled her into the laboratory.

Once inside, soft music could be heard from the corner of the lab. In the center of the room was a padded narrow table upon which she was asked to climb. She laid back and the remaining monitoring devices were connected and the procedure table brought nearby. She was quiet, but looked incredibly anxious.

“Why don’t we give her a little Vitamin V?”

Vitamin V: our code word for Versed (midazolam), a wonderful, short-acting benzodiazepine that helps reduce anxiety and typically has a mild amnestic effect, helping to make the memory of the procedure less vivid. And so the nurse complied:

“1 and 25,” she said.

“1 and 25, aye,” echoed the technician in the control room as the drug times and dosages were entered in the procedure log. (Translation: Versed 1 milligram and Fentanyl, 25 micrograms.) Gradually, I saw the drugs take hold and he slept comfortably as I proceeded to perform her catheter ablation. All went smoothly and it was time to prepare the lab for the next case.

“We’re all done, Ms. Jones!”

“Really? That wasn’t so bad. Thank you.” And she dozed off again and we carried her out to the recovery area. Another one for the books, I thought. And I heard nothing further. She left for home.

Two weeks later she returned with her husband to my office for a follow-up check.

“How do you feel, Mrs. Jones?”

“I feel great, Dr. Fisher. I used to have those arrhythmias nearly every day, and since that procedure, I haven’t had any. It’s wonderful.”

Sweeter words were never heard by an electrophysiologist. It’s what makes this job so great...

... at least until her husband told me what happened after she left the hospital.

“You know, a funny thing happened the day of my procedure,” he said.

“What was that?” I asked.

“Well, everything seemed to be fine. She had lunch before she left, and as we headed home, she asked if we could stop and buy some groceries. Now being a good husband, I figured, why not? So off we went to the local grocery store we went on our way home. She went down every aisle and loaded up two shopping carts of groceries. We spent over $400! I’ve never spent that much for groceries.”

“Really?”

“So we drive home and she and I unloaded the car – all thirty bags of groceries and piled them high on the kitchen counter. She said she was tired, so I offered to put away the frozen things, and she headed upstairs to nap. I decided to rest for a while on the couch, too, before putting away the rest of the ‘em.”

“Yes?”

“Well, I didn’t think about it much until two hours later she returned downstairs and went in the kitchen. Shortly thereafter, she woke me on the couch and asked, ‘Who bought all of the groceries?’ Damn doc, could that have been those medications?”

I smiled hesitantly. It seems I’d missed one potential complication of the procedure: the powerful amnestic effect of midazolam.

-Wes

Photo credit.

On Gucci and Gouging

If there was any chance at real health care reform, it was going to start with restricting direct-to-consumer (DTC) advertising from the pharmaceutical industry. The thought that Congress had any real modicum of desire to really change the health care climate today went up in smoke yesterday when the FDA's budget, paid in large part by pharmaceutical interests, was approved by "consumer safety-conscious" congressmen and congresswomen. We need such advertising for pharmaceutical companies, they argued, to assure effective monitoring of DTC ads to assure patient safety!

Huh?

Hey guys and gals, if we didn't have the ads in the first place, they wouldn't have to be monitored, would they?

But there were just too many powerful interests protecting their turf. One quip from the Wall Street Journal's Health Blog really hit home:
But it wasn't Big Pharma that carried the day on the revision; it was the Gucci-loafered lobbyists for media and advertising firms.
Real health care reform doesn't stand a fricking chance as long as our elected officials (and this includes every one of our comb-over presidential candidates) don't take their job seriously and start to vote on behalf of America's best interest, instead of their own.

-Wes

Thursday, September 20, 2007

The Problem with Health Policy Initiatives

A. The Old Days
A patient walks into the emergency room, complaining of a weak arm and hand for four days.

A careful history is taken to determine the distribution, timing, precipitating and palliating factors, and severity of the weakness. The patient notes that buttoning clothes and picking up objects with their left hand has become increasingly difficult. A carefully performed physical examination discloses mild swelling and tenderness of the metacarpophalangeal joints, hyperreflexia of the biceps and brachioradialis muscles on the left arm. Pin prick, temperature sensation, and propioception are reduced in the digits of the left hand. Pronator drift is noted of the left hand. Flexion and extension of the biceps muscle on the left is reduced. A disorder of the central nervous system is suspected, a careful conversation is had with the patient to explain the symptoms and diagnostic process. A CT scan is ordered and later documents a 3 cm radiolucent mass in the right motor cortex. Doctor returns to patient and explains the findings. A neurosurgery consultation is requested. Total time: 2.5 hours.

B. The New Days
A patient walks into the emergency room, complaining of a weak arm and hand for four days.

A CT is ordered and patient is wheeled to scanner. CT documents a 3 cm radiolucent mass in the right motor cortex. Doctor sees findings, calls neurosurgeon. Doctor and neurosurgeon enter room to discuss CT findings with patient. Total time: 25 minutes.

Two tactics, same outcome. Process B ten times as efficient as A. Therefore, process B must be better than A, right?

It depends on which side of the health care debate you're on.

-Wes

Wednesday, September 19, 2007

Say It Ain't So

... the death of the stethoscope? Somehow placing recordings of heart and breath sounds from an MP3 player/recorder in the medical record seems a bit extreme, but hey, such a device could probably do it. The real question is, would anyone stop and listen? With ever-growing pressure to improve "productivity," I doubt it.

But the best part? I'd stop looking like a doctor and look like this guy.

I'm sure that look would engender total confidence in my clinical skills by my patients.

Then again, maybe not.

-Wes

Leapfrog's Best Hospitals


Although I'm not a real fan of rating systems for hospitals, it seems congrats are in order for Evanston Hospital for their inclusion as one of the Leapfrog Group's 41 best hospitals in the US:
The 2007 Top Hospitals list is based on 1,285 hospitals that responded to the Leapfrog Hospital Quality and Safety Survey as of August 31. Top Hospitals fully meet Leapfrog’s standard for ICU Physician Staffing (IPS) and the Safe Practices Score (SPS) and either of the following: (1) Two or more of the eight Evidence Based Hospital Referral (EBHR) areas; or, (2) Computerized Physician Order Entry plus one of the eight EBHR areas. Thirty–three hospitals meet these criteria. Top Children’s Hospitals fully meet the standard for IPS, SPS and the EBHR Neonatal ICU standard for high-risk and complicated newborns. Eight children’s hospitals meet these criteria.
I may whine, rant, and complain from time to time, but all told, the admin folks do a pretty good job here.

-Wes

Reference: The Leapfrog Group's methodology.

Tuesday, September 18, 2007

Letting the World Know About Me

I just completed the mandatory online physician database required by the Illinois Department of Financial and Professional Regulation. Haven't heard about this? Well here's a few of their recent frequently asked questions and answers:
1. Who is required to complete a Profile?
Amendments to the Illinois Medical Practice Act require all physicians and chiropractors licensed in Illinois to complete a Profile as part of a public information database maintained by the Department of Financial and Professional Regulation.
2. What if I don’t complete the Profile?
Your participation is mandatory and therefore failure to review, verify and complete your profile could result in fines or other disciplinary action being taken against your license. Additionally, licensees will not be allowed to renew their license in until he/she has completed the profile.
3. Who will able to see the Profile data I enter?
Beginning in 2008, all Profiles may be viewed and printed by the public using a Profile Search link which will be accessible from the Department of Financial and Professional Regulation website.
4. What profile information is required?
Primary office location(s), Hospital Affiliations (if you have any), Medicare acceptance, Medicaid acceptance, Illinois AllKids participation, current Board Certifications, Medical School and Post Graduate Education. All other required profile information, such as full name, license origination date, license status and disciplinary data are retrieved from the DFPR Licensing system and cannot be modified in the Profile.
Now I'm happy to provide the information for licensure to our state, but the general public? Lord knows there have been several instances of physician imposters described in the press, and armed with enough information for the public, one wonders if other instances will arise. And armed with this information, what assurances for my personal and financial security will the state of Illinois supply in return? Will they pay for an Equifax acount to protect my credit report to solicitous attempts at stealing my identity?

Scary times are ahead in 2008 as government intervenes more and more on the practice of medicine.

-Wes

Grand Rounds at the Stop and Blog



Medical blogging's Grand Rounds is hosted by Six Until Me this week. Feel free to shop 'til you drop.

-Wes

Monday, September 17, 2007

Psychiatrists Beware: Vitamin H Causes Torsades

It's official: the FDA reported that Johnson and Johnson made labeling changes for haloperidol (Haldol®, aka "Vitamin H") regarding its propensity to prolong the QT interval. Haldol's addition is not surprizing given the many other psychotropic drugs already on the list of drugs that can prolong QT interval and cause Torsades de Pointes ventricular arrhythmia (a potentially lethal form of heart arrhythmia).

Haloperidol, however, is considered indispensable for treating psychiatric emergency situations and is enrolled in the World Health Organization List of Essential Medicines. This labeling change should be noted by physicians treating the elderly, since this drug is often administered to aggitated seniors in the hospital or nursing home and might have synergistic effects with many other commonly prescribed antibiotics, antacids, and pain medications that also prolong QT interval.

-Wes

Reference: QTDrugs.org - University of Arizona's College of Pharmacy database of QT interval prolonging medications.

No More White Coat Syndrome

Here's one way to cure White Coat Syndrome: rid the doctors of their white coats.

It seems the recommendations is an infectious disease-related one since those long sleeves are thought to carry cooties germs.

But what these researchers failed to control for was likely this pioneering 'research' by some remarkably desperate soles from the Soap and Detergent Association:
Researchers staked out restrooms at different types of venues in four U.S. cities: Chicago's Shedd Aquarium and the Museum of Science and Industry, Atlanta's Turner Field, New York's Grand Central Station and Penn Station and San Francisco's Ferry Terminal Farmer's Market.

Men's hygiene was worst at Atlanta's Turner Field, where just 57 percent of men were observed washing their hands after using the toilet at the baseball venue. But 95 percent of women there washed their hands, the highest percentage observed in the study.

Chicago was the city with the cleanest hands overall. New York was the second-cleanest, Atlanta came in third, and then San Francisco.
Can you believe this stuff? I mean, I'm so PROUD of gool ol' Chicago! We're all such clean Leave-It-To-Beaver types! Do you think the White Coat Researchers tested their germ-carrying claims in different cities? I mean, we have solid clad 'research' supporting the superior cleanliness of Chicagoans who visit public restrooms, don't we?

What's that you say? There might be a little snag in the Soap and Detergent Association's claims - that they might not be so "clean" in their reporting after all?
The researchers could not account for why people appear to be washing their hands less in public bathrooms. And they admitted that because the research was done in different venues, it was not scientifically valid.
Oh shucks. It looks like JCAHO will soon be asking us to follow the Brits' advice and lose those white coats after all.

Well at least my patients won't be able to blame me for their high blood pressure now.

-Wes

Reinventing Guidelines

Dr. Robert M. Centor over at DB's Medical Rants makes some great suggestions how to improve medical guidelines. I suspect he read the 158-page guidelines on the management of patients with unstable angina and non-ST-segment elevation myocardial infarction released this year by the American College of Cardiology and American Heart Association. It was so long that they even had to publish a separate "shorter" 76-page "Executive Summary" publication to summarize them.

At the current rate of guideline growth, I suspect we'll need to store them here.

-Wes

Friday, September 14, 2007

Long-term EKG Monitor

Are you one of those people who passes out infrequently, and really wants to know why?

At present, the "state-of-the-art" monitoring of undiagnosed arrhythmias is provided by Medtronic's Reveal Plus monitor (seen at right). This device can hold up to 42 minutes of heart rhythm in its memory, and triggers its storage when the heart rhythm exceeds certain high or low boundaries.

As technology marches on though, the ability to monitor a patient's heart rhythm will soon get even longer. Now researchers in England are testing the Transoma's "Sleuth," a device housed in a pacemaker-like can that transmits 48 hours of continuous heart rhythms from a basestation connected to the internet:
The Sleuth acts as an aerial and sends a recording of the heart beat to a mobile phone sized activator.

The activator clips onto the belt during the day and plugs into the phone at night.

Recordings are sent over the internet to a company in New Jersey, in the USA, which analyses the information and sends the results back to consultants in Eastbourne.
Although a niche device, the company hopes use continuous telemetry to monitor ST segment abnormalities as a measure of heart ischemia and is also developing a surgically-implanted continuous left ventricular pressure monitor.

-Wes

References: Transoma's press release.

Thursday, September 13, 2007

Sensitivity Training

We interrupt your schedule to bring you the latest Sensitivity Training...

I had quite a few cases today, but was reminded of an important aspect to any procedure that is performed in our laboratory: the proper way to give a local anesthetic.

Now the casual observer might think this is a minor issue - unless they're the one receiving the anesthetic.

Local anesthetics have revolutionized modern medicine: it is remarkable that I can implant a permanent pacemaker or an automatic defibrillator, or perform a catheter ablation procedure with the patient being awake, alert, and oriented throughout the procedure if necessary.

But the initial injection of the local anesthetic requires reassurance to the patient that they can get through the initial shock caused by the sting of the administration of the anesthetic, especially when working in the femoral triangle (near the groin area on the front of the leg where the hip joint bends).

What is said by the physician should be classified as "Green Light," "Yellow Light," or "Red Light" warnings (By the way, I have heard each of these used, so listen carefully):

GREEN LIGHT
"Mrs. Smith, I'm going to numb up your skin where we'll be working now. You're going to feel a little pinch and burn down here as the anesthetic goes in and then you'll be numb." (No over-dramatization, just the facts).

YELLOW LIGHT
"Mrs. Smith, I'm going to numb up your skin where we'll be working now. It will feel a little bit like a bee sting." (I never thought bee stings were a mild discomfort. Hence, this might make the person unduly anxious).

RED LIGHT
"Mrs. Smith, I'm going to numb up your skin where we'll be working now. You're going to feel a little prick down here." (Wrong. Just wrong.)

Now, back to your regularly scheduled procedure...

-Wes

Wednesday, September 12, 2007

St. Jude and J&J?

Oh boy, the rumor mill's a churnin'.

-Wes

Endangered Species


A Regular Sphygmomanometer (Blood Pressure Cuff)
Have you notice how manual blood pressure cuffs are becoming extinct on hospital wards? I'm adding them to my "endangered species" list. It seems fewer and fewer people use these on the inpatient wards anymore. Instead, hospitals seem to be gravitating toward wall-mounted or cart-mounted electronic versions that can take your temperature and pulse oximetry, too, like the one to the right.
These electronic versions do not require the use of - dare I say it - a stethoscope and ears. (I've already commented on the quality of stethoscopes has suffered with the advent of the little plastic stethoscopes, so with these new-fangled gizmos, we don't even need those!).

One reason hospital administrators have migrated away from these manual BP cuffs is because they have lots of complicated detachable parts - the rubber bulb cracks and loses air, the tubing similarly fractures, and the calibration of the BP meter itself was difficult to maintain from the heavy use these devices see. But the new devices have even more issues, it's just that now we have to call a specialist to fix them. But, hey, at least they look cool.

The mobility of these old-fashioned, untethered devices had several advantages over their technogeek counterparts: (1) they permitted measurement of blood pressures in different patient positions - supine, sitting, and standing (recall that we call these orthostatic blood pressures) - since they are less resistant to motion artifact and (2) the manual version can recognize a drop in blood pressure faster than you can say "Holy Sh**!" Many a poor patient has hit the deck while the techoversion keeps inflating the cuff higher and higher in its attempts to find a hypotensive patient's blood pressure.

Recently, I have been struck by the number of patients I have seen with loss of consciousness (syncope). Most are men over 70, and most of them on a ton of medications - and all episodes of syncope seem to generate a consultation for the cardiac electrophysiologist (my kids appreciate this - really they do).

But one of the more common drugs I see elderly men on are medications for prostatic hypertrophy - in particular, terazosin hydrochloride (Hytrin®) or tamsulosin hydrochloride (Flomax®). These medications are prescribed for benign prostatic hypertrophy (BPH) to improve urine flow, especially at night.

But they also can drop blood pressure.

And nothing will make you hit the deck faster that a full bladder, warm body (after being in bed), rapidly standing, and being on too much Hytrin - blammo - down like a ton of bricks. Quick, call the electrophysiologist for a pacemaker!

For some reason (and I suspect its the abandonment of the manual BP cuff), few people check orthostatic blood pressures anymore, and so a simple diagnosis (and treatment) is missed.

But then again, I guess I shouldn't complain.

-Wes

Tuesday, September 11, 2007

Lest We Forget

9/11/2001: A remarkable video.

-Wes

h/t Instapundit.

The AHA and Medical Fear Mongering

If you have a pacemaker or implantable cardiac defibrillator, slipping an iPod into your shirt pocket, or walking past anti-theft equipment at the mall, could make your device go haywire - true or false?
This is the second question of a quiz (available online) from the August 2007 Heart Insight magazine, an official publication of the American Heart Association (AHA) published quarterly by Wolters Kluwer Health, a division if Lippincott Willliams & Wilkins publishers. It is a slick, glossy publication and was being offered for free to our patients:


So today, a patient left this for me on my desk:



It is the "answer" to the above question that appeared in their journal, circled by a patient with the question penciled beside it, "Is this true?"

Now on the surface, such a quiz seems innocent enough. After all, it's meant to inform. But look what it has done to one of my patients. THe patient is asking, Could this happen to me?" This person is concerned. Scared. Fearful.

This how our own AHA wants to get their message across, I guess.

But when one really looks at the information provided in the answer to the question, we find the real answer in amongst the confusing array of sound bites:
"Researchers found that MP3 players such as Apple's iPod, interfered with pacemaker function in half of the 83 patients who participated in the study; none of them experienced symptoms."
So there you have it. None of them experienced symptoms and, by the way, none of the patient's devices went "haywire."

Not one.

The supporting study (actually a case report) pertaining to the first part of this answer appeared in the peer-reviewed journal Heart Journal in June 2007. This case study studied the interference of an iPod held within two inches of pacemakers. It found very minor, non-lethal interference (usually undersensing of the patient's intrinsic heart rhythm) in most cases. No patient was harmed. In fact, no patient was tested with the device in their shirt pocket. From the article:
In our patient, oversensing did not result in pacemaker inhibition or noise reversion; it was evidenced only by pacemaker interrogation that showed high atrial or ventricular rates on rate histograms. This may lead the physician to conclude that the patient had experienced atrial fibrillation (Figure 4) or ventricular tachycardia (Figure 2) and result in unnecessary antiarrhythmic drug therapy or electrophysiologic investigations. These high rates also may be misinterpreted as suggesting loose set screws or intermittent lead fracture and may lead to unnecessary interventions. Interference caused by iPods appears to be reproducible from day to day, but whether repeated applications have a cumulative effect on rate histograms is not known.

We performed testing by applying the iPod approximately 2 inches above the pacemaker. This may appear to be somewhat artificial but is, in fact, quite realistic because iPod devices often are carried on an armband or in a shirt pocket during use. If the iPod is placed in an ipsilateral shirt pocket, it certainly may be close enough to cause interference. Furthermore, electromagnetic signals emitted by handheld devices probably are of low power, and the strength of the signal falls dramatically over distance. However, because iPod devices may be carried close to the pacemaker, there may be a potential for clinically significant interference.
Also, the article did not study ANYTHING about the interference of electronic surveillance systems in malls with pacemakers or defibrillators. But rather than be true to their readers (our patients), it seems the AHA had to add the bit more fear-factor by citing rare case studies (see references 1 and 2 below) where patients had to go to ER's for "malfunctions of the heart devices," even though other studies, while acknowledging that interference can occur, actually demonstrated the safety of patients walking through electronic surveillance systems with defibrillators. Once again, no devices went "haywire" but rather responded appropriately to the noise detected by the device.

So why does our own American Heart Association, in its new "official" publication, condone such fear mongering of our patients, even when their own website claims minimal risk to patients in these settings. What benefit does this serve? Is this medical marketing tactic in our patients' best interest? Shouldn't the AHA provide more journalistic oversight than appears on the Today Show?

Or is the sensationalist content more important to their egos?

-Wes

References:
(1)Peter A. Santucci, M.D., Janet Haw, R.N., Richard G. Trohman, M.D., and Sergio L. Pinski, M.D. Interference with an Implantable Defibrillator by an Electronic Antitheft-Surveillance Device New Engl J Med 1998; 339:1371-1374.

(2) Interactions between Cardiac Pacemakers and Antishoplifting Security Systems. New Engl J Med Nov 5, 1998: 339: 1394-1395.

(3) Harthorne, J. W., Barach, P., Baum, E., Santucci, P. A., Pinski, S. L., Trohman, R. G., McIvor, M. E., Sridhar, S. (1999). Implantable Defibrillators, Pacemakers, and Electronic Antitheft Devices. New Engl J Med 340: 1117-1119. A rebuttal to the first two case reports above.

(4) William J. Groh, MD; Scott A. Boschee, BS; Erica D. Engelstein, MD; William M. Miles, MD; M. Erick Burton, MD; Peter R. Foster, MD; Barry J. Crevey, MD; Douglas P. Zipes, MD Interactions Between Electronic Article Surveillance Systems and Implantable Cardioverter-Defibrillators Circulation 1999; 100: 387-392.

(5) Mehul B. Patel, MD, Jay P. Thaker, Sujeeth Punnam, MD, Krit Jongnarangsin, MD. Pacemaker interference with an iPod. Heart Rhythm Volume 4, Issue 6: 781-784 (June 2007).

Monday, September 10, 2007

Buyer Beware

Although I've said it before, now comes data to back me up: lots of defibrillators are being implanted by non-trained personnel:
Data from the National ICD Registry, published in the medical journal HeartRhythm this month, showed that 15 percent of the 3,249 doctors tracked in the registry who implanted defibrillators last year lacked formal training in the procedure. These physicians accounted for 6 percent of all implants included in the registry in 2006.
Although the implant itself is not much more difficult than a conventional pacemaker implant, the real issue is this: (1) will the unskilled doctor be capable of handling unusual circumstances and (2) are the doctors implanting these devices skilled at their follow-up and revision?

The implant of the device typically takes one to two hours of the patient's life to perform, but the follow-up of this device is required is for the rest of the patient's life. I suspect many of the implanting physicians without credentials are often from geographically remote centers without an electrophysiologist nearby. But the real issue in implantation is having enough experience to know when a particular implant approach (such as subpectoral) might be in the patient's best interest by avoiding the later complication of erosion and infection of the device. And there is no substitute for having the skills to manage the patient's device proactively to avoid later complications.

So it's buyer beware out there: find out what your doctor knows and what training he has before you commit to any surgery, especially defibrillator implantation.

-Wes

Sunday, September 09, 2007

Cardiologist Gone Wild

Imagine a cardiologist striking a patient during a catheterization procedure.

Impossible?

Well, apparently not.

And given the 54 comments so far, many have plenty to say about it.

Now I have no clue what transpired during the procedure described. Certainly witnesses were disturbed enough to report the doctor. After all, striking a patient is never appropriate. But it would not be a far stretch to see how the means of forceful restraint might be perceived as abuse, since the patient is usually in no condition to cooperate at such times. Occasionally, patients respond paradoxically to the sedative medications we administer during procedures and become combative and some even try to leave the table in the middle of their procedure. I have experienced patients becoming markedly agitated during pacemaker implants and have had to quickly call on my technicians and nurses to hold a patient so they would not contaminate the sterile surgical field. Often, we have had to physically restrain patients while calling for our anesthesia colleagues to safely sedate (and if necessary, paralyze them) with more powerful drugs to assure patient safety.

Now add to that scenario full anticoagulation and a wire structure in their coronary artery and one can see how tense such moments can become.

And where to most patients have the most strength?

Their legs.

And where do interventional cardiologists usually work?

From the patient's leg(s).

So when the two individuals do not cooperate during a procedure, it can be very intense, indeed.

I guess I'd let this one play out in the courts, since this is assuredly where this situation will end up. It's just a shame for all involved.

-Wes

h/t: Kevin, MD.

Hospital Chaplains

A nice article by Barbara Mahany appears this morning in the Chicago Tribune on the role of one hospital unsung hero: the hospital chaplain:
"There are so many metaphors with children and nighttime. We give them a night light. We give them milk and cookies, security blankets, bedtime prayers. Those things are amplified when a child is in a hospital, taken away from everything they know. It's a great entry point for the spirituality of a child, creating a place of security amid all the unknown"
-Wes

Saturday, September 08, 2007

Eating American Pie

After our EMR (electronic medical record) died today, I wrote a little jingle, with apologies to Don McLean:

Computer-based Pie

A long, long time ago...
I can still remember
How those paper charts had made me smile.
And I knew if I had my chance
That I could make those patients dance
And, maybe, they’d be happy for a while.

But yesterday made me shiver
When the computer failed to deliver.
Bad news on the doorstep;
We couldn’t take one more step.

I can remember that I cried
When nurses orders just up and fried,
But something touched me deep inside
The day the Computer died.

(Chorus)
So bye-bye, miss Computer-based pie.
Drove my patient near the levee,
But the levee was dry.
And them good old docs were drinkin’ whiskey and rye
Singin’, "this’ll be the day that they die.
"this’ll be the day that they die."

Could you find a progress note,
Or an order sheet for the nursing bloaks,
Or a way to float this boat?
Documentation no longer shows,
And billing ceases, you pay the toll,
So can you teach me how to chart real slow?

Well, I know that you’re in deep kimshee
`cause I saw you writin’ along with me.
We both kicked off our shoes.
Man, I dig these paper-based blues.

I was one happy old-time doc
With pink tri-fold orders and a pickup truck,
But I knew the young ones were out of luck
The day the computer died.

(Chorus)


-Wes

Friday, September 07, 2007

Why People Should Consider Using Their Name for Blogging

In case something like this occurs.

-Wes

Unitedhealth Gets Off Easy

I was going to comment on the ridiculously small sum ($20 million) UnitedHealth will have to pay the 36 states as part of a settlement to resolve problems with the insurer's claims-paying systems. Fortunately, Dr. Rich Fogaros over at The Covert Rationing Blog nails it on the head:
First, the insurance companies themselves are the only entities that fully understand their labyrinthine reimbursement schemes; they control the process. In this light it is telling that UnitedHealth Group and the regulators have been “negotiating” the “improved” reimbursement procedures for at least a couple of years. In a culture swimming in seamless electronic processing systems, the puzzle of simplifying claims processing should have been solvable in a couple of weeks.

Second, remember that the Wonkonians themselves, in the guise of Medicare and Medicaid, are also deeply engaged in purposefully mysterious reimbursement schemes. One suspects that there’s a limit to how far they’ll push the insurers toward transparency and simplicity, lest the expectation for similar processes is turned back on them.

Third, when was the last time any regulators have ever been able to simplify anything?
And when one figures that $6 million of that payout will go to New York alone (for their time and effort, I guess) and divides up the rest evenly among 35 states, we see that the other states get paid, on average, a little over $570,000 each.

Now compare that the top 25 CEO pay amounts (salary, bonus, exercised options and vested stock grants) for 2005 (the year the original suit was filed). We see that all twenty-five received over $35 million EACH in a single year.

Sorry, but when UnitedHealthcare CEO Kenneth Burdick says: “This new, forward-thinking approach focuses the regulatory process for the states and our company on a practical set of uniform performance standards, while providing clearer and more meaningful means of assessing how well we are serving customers.”

We get, it Ken. Crystal.

You won.

Guess we can look for those premiums to rise again next year to cover the cost of these "uniform performance standards," eh?

-Wes

Thursday, September 06, 2007

Coreg on the Cheap

Big news from the FDA today for our heart failure patients:
The U.S. Food and Drug Administration today approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

"The agency's Office of Generic Drugs ensures that generic drugs are safe and effective through a rigorous scientific and regulatory process," said Gary J. Buehler, director, FDA's Office of Generic Drugs. "Generic drugs, which use the same active ingredients as brand-name drugs and work the same way, offer alternatives to Americans in choosing their prescription drugs."

Carvedilol tablets in four strengths (3.125 milligrams, 6.25 milligrams, 12.5 milligrams and 25 milligrams) are manufactured by multiple generic drug companies. The following company’s applications were approved today: Actavis Elizabeth LLC; Apotex Inc.; Aurobindo Pharma Limited; Caraco Pharmaceutical Laboratories Limited; Dr. Reddy’s Laboratories; Glenmark Pharmaceuticals Limited; Lupin Limited; Mylan Pharmaceuticals Inc.; Ranbaxy Laboratories Ltd.; Sandoz Inc.; Taro Pharmaceutical Industries Ltd.; TEVA Pharmaceuticals USA; Watson Laboratories Inc.; and Zydus Pharmaceuticals USA Inc.
Generic cardedilol is likely to be MUCH cheaper than the once-a-day Coreg CR, or conventional Coreg tablets. No word yet when it will appear at your local Walgreens, Wal-Mart or CostCo.

-Wes

Why I Have the Best Job in the World

I was laughing as I read the Independent Urologist's post (especially the comments) on why his job is better than a professional tennis player's job. I don't think I can ever compete with the jokes a urologist, gynecologist or proctologist must encounter during their day-to-day interactions with patients, but I just can't imagine any job cooler than mine. Here's why:
  1. Our technology is “way cooler” than the iPhone or the new iPod touch – imagine waving a wire around in someone’s heart to generate a 3-D reproduction of their anatomy! (see figure) Cool.

  2. Where else can someone place a few wires in someone’s heart under a local anesthetic and permanently cure a patient of their lifelong arrhythmia in as little as an hour and have them walk home four hours later?

  3. My services are still in demand and appear to be growing.

  4. Pacemakers. Probably the single best invention to improve one’s quality of life. One minute the person is lying head-down in Trendelenberg position with a blue face and anxious look with a heart rate of 20 – and with the placement of a wire in their heart, watch them turn pink, smile, and joke about their earlier predicament – amazing.

    Almost more amazing is the ability of placing a third pacemaker wire to the far side of someone's severely weakened heart to help improve its function and their quality of life. Awesome.

  5. Defibrillators. Despite the media negativism recently, these devices are miraculous engineering marvels that can monitor fast and slow rhythms 24/7/365 and treat them, if needed, with a life-saving shock. I will never forget a young woman I saw years ago – a young mother (age 34) with two kids and a loving husband who was diagnosed with a cardiomyopathy (very weak heart muscle) but felt absolutely fine. She had lost a brother at age 30 of sudden death. She was initially very resistant to having a defibrillator placed, but finally agreed to the procedure after several weeks of consideration and second opinions. Her implant was uncomplicated.

    One year later, while walking with her girls on a late summer evening, without warning, she collapsed and woke to see her two girls asking her why she fell. She wasn’t sure. So she came into our office. We checked her device and found she had a sudden episode of ventricular fibrillation and was resuscitated by her device. She remains alive today.
Yeah, baby, this job’s the best.

-Wes

Dronedarone - A Safer Amiodarone?

Today, the New England Journal of Medicine reports on the safety and efficacy of dronedarone (Sanofi-Adventis (SNY) from the identically-designed EURIDIS and ADONIS (American-Australian-African trial with DronedarONe In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm) trials. Dronedarone was effective at reducing the time to recurrent atrial fibrillation compared to placebo.

From this press release:
The ADONIS study showed that the median time from randomization to a first adjudicated AF/AFL recurrence was 2.7-fold longer in the dronedarone group than in the placebo group. Dronedarone significantly decreased the risk of a first recurrence of AF/AFL within the 12-month study period by 27.5% compared to placebo (log-rank test p=0.0017).

Most initial AF/AFL recurrences were symptomatic in both groups of patients. Overall incidence of adverse events was comparable in the two groups (73% in the placebo arm and 80% in the dronedarone group, (p = ns)) and dronedarone also displayed good cardiac tolerability, with no cases of torsades de pointes.
This trial was so reaffirmed earlier reporting of the trials from 2004 regardings to the long-term efficacy of the drug. As in the earlier 2004 reporting, this trial still demonstrated a disappointing recurrence rate of atrial fibrillation in the treatment group:
At 1 year of follow-up, the risk for AF recurrence in the European arm of the study was 67% with dronedarone, compared with 77% with placebo; in the non-European arm, the risk for AF recurrence was 61% with dronedarone, compared with 73% with placebo.
It was important to note the following about the use of dronedarone in patients with congestive heart failure (from the NEJM article):
A previous study, the Antiarrhythmic Trial with Dronedarone in Moderate to Severe Congestive Heart Failure Evaluating Morbidity Decrease (ANDROMEDA), was discontinued early because an interim safety analysis suggested a potential increase in the risk of death with dronedarone therapy. The discontinued trial involved patients with moderate-to-severe congestive heart failure and ventricular dysfunction, and thus investigated a different (and higher-risk) population than the patients we studied. In our trials, the rates of death from any cause and sudden death in the dronedarone group did not differ significantly from those in the placebo group. Nonetheless, the experience with the ANDROMEDA trial indicates that dronedarone may be associated with an increased risk of death in patients with advanced congestive heart failure and that the drug should not be used in such patients until appropriate data are gathered.
This is an important distinction between dronedarone and its cousin amiodarone (which can be used in these higher risk patients). Still, given the limited number of effective medicines available for treatment of atrial fibrillation these days, the drug may still fill an important niche.

-Wes

References:

Bramah N. Singh, M.D., D.Sc., Stuart J. Connolly, M.D., Harry J.G.M. Crijns, M.D., Denis Roy, M.D., Peter R. Kowey, M.D., Alessandro Capucci, M.D., Ph.D., David Radzik, M.D., Etienne M. Aliot, M.D., Stefan H. Hohnloser, M.D., for the EURIDIS and ADONIS Investigators. "Dronedarone for Maintenance of Sinus Rhythm in Atrial Fibrillation or Flutter" New Engl J Med, September 6, 2007, 357 (10):987-999.

Medscape (free registration required).

Wednesday, September 05, 2007

Robotic Marketing

Imagine buying a Mercedes Benz luxury car to take a trip. You save your hard-earned cash and spend handsomely for the car because of its human engineering, reputation and admire its comfort during a test drive. You drive it from the dealer and find the car’s the rage as it sits in your driveway. You gloat over its finish and detailing. You’re the envy of the neighborhood.

And then you find out the trip is a transatlantic one, and you should have bought a boat instead.

Such is the lure of technology in medicine. It seems all too often the development, manufacturing, and marketing of devices, especially high-tech robotics, has exceeded our understanding of the mechanisms and etiologies of the very diseases we hope to treat. And it is sexy.

But others have argued that such technology does nothing but contribute to hospitals' technical arms race.

Such is the case of atrial fibrillation ablation.

I am struggling with the decision of obtaining a device to perform robotic-assisted catheter ablation of atrial fibrillation. There are several devices now on the market. One is a mechanical robotic sheath system from Hansen Medical that purports to "extend my reach" to locations within the left atrium better and with more precision, and the other a system from Stereotaxis that uses a powerful magnetic field to provide "a softer touch to the treatment of heart disease."

Both systems have their pros and cons. Both are expensive.

But despite huge leaps in our understanding of atrial fibrillation and its mechanisms, the more I understand the arrhythmia, the more I have come to believe that we still don’t understand the mechanisms at play in the individual patient. For instance, why do some patients with normal-sized hearts get atrial fibrillation while others do not? Why do some patients with huge left atria from mitral stenosis sometimes never manifest the arrhythmia, while others are debilitated by it? What are the long-term mortality data with ablation compared to drug therapy? With the complications of the procedure (which admittedly are rare in skilled hands), are these still less than the complications of anticoagulation or drug therapy? What really is the role of neurologic (ganglionic) inputs to the heart at supporting atrial fibrillation versus fibrous remodeling or pulmonary disease?

And while these robotics are ingenious instruments, can they really replicate the remarkable tactile feedback of the human hand and assure the safety of these uncharted waters? Will they respond as quickly to visual and tactile clues afforded by our senses at the patient's bedside? And where should we ablate? Do we really need such complicated and expensive machinery before more basic questions are answered?

Certainly the FDA has approved these devices as safe. But this does not guarentee improvements in ablation efficacy. These early approvals to little to reassure those of us in the day-to-day clinical grind of these devices' cost effectiveness. For instance, despite all of the testing in human volunteers of the magnetically-driven system by Stereotaxis, I was left to wonder how this system was approved with its propensity to developing large char formation compared to more conventional approaches. Was this not seen in earlier trials? Didn't this affect the movement of their catheter as it welded to the left atrial surface? Wasn't this considered important? How much additional time did correcting these problems add to the procedure?

Perhaps in the end it won’t matter. Perhaps the ablation lesion sets during atrial fibrillation ablation procedures will be so defined so accurately through brute force trial-and-error that we will simply push a button and, like a car wash, a catheter will be dragged through a pre-defined course that’s the same for everyone and everyone's atrial fibrillation will be magically cured. As if everyone's atrium was the same size and shape.

But then again, maybe before buying our "Mercedes," we should first look to see if we need a boat instead.

-Wes

Caregivers

* bleep bleep bleep bleep bleep *

I felt a cold chill run through my veins as a wave of sweat exuded from my pores. My head had just hit the pillow an hour ago, and my rem cycle, which had come rapidly, was interrupted once again. I fumbled for the pager and sat at the edge of the bed. I pushed the button, but couldn’t read a thing – it seems the illuminating light on the pager had bit the bullet long ago. Damn.

So I shuffled in to the room next door and switched on the desk lamp. My eyes withdrew at the glare and my eyelids felt a bit like sandpaper as my eyes drew into focus:

x5816

The ICU. *sigh* Wish it had been someone else.

I called.

“Dr Fisher?”

“Yep,” said briefly, so as to conserve energy.

“How do I get a defibrillator turned off on a patient who’s expectant?”

I thought for a moment. I realized I could try to talk the resident through this, but it would be a hassle, and calling a device company rep to do this seemed inappropriate, so I succumbed.

“Can it wait until the morning?”

“I don’t think so.”

“Okay, I’ll be right in.”

The drive in was refreshing, and served to helped resuscitate my brainstem. It was a clear, warm night. I went straight to the cath lab and grabbed the programmer for the defibrillator and arrived in the ICU. There, staring up to the ceiling with his mouth open was a frail man who had clearly fought valiantly his last battle. He seemed comfortable, breathing rapidly, but certainly unaware of his surroundings. He was much skinnier than I had remembered him from six years prior, for I had placed his device. I called to him, but there was no response. He was busy transitioning from this world.

So I programmed off the tachycardia detections of his device and returned to the nurse’s desk to record my actions on the patient’s medical record. Soft music hung softly at the desk above the drone-like din of the nearby monitors. The resident was fascinated by the technologic wonders of the technology at my fingertips as I explained the principles of the device programmer. The old man’s nurse approached.

“Thanks for coming in.”

“Thanks for calling,” I said.

I looked on the desk and there were two huge jars of peanut butter, an open bag of miniature Hershey’s dark chocolate bars, and a bag of miniature pretzels.

“Dinner?” I asked.

“No, just a snack, but they provide real energy at times like this. Try it. Just put some peanut butter on the chocolate bar, and then add a pretzel. Help yourself. You’ll feel better. I’m going to go in there to stay with him.”

I tried the chocolate and peanut butter but passed on the pretzel. It was a taste sensation like no other at two in the morning. Nurturing. And as I typed my note I couldn’t help but think about that nurse: an expert at care from all angles. I peered in the room and saw her holding his hand. There she was, someone who quietly cared about a dying, feeble man who was moving from this world to the next and who didn’t want him to be alone.

I suspect such scenes are repeated countless times in ICU’s around the world but you never hear about them.

Until now.

-Wes

Monday, September 03, 2007

Boston Scientific’s Legal Paperwork Payoff

It’s enough to make you sick. The Attorney Generals from 35 states, seizing on the vulnerable, sue Boston Scientific because they smell blood, pay themselves instead of patients, and feel virtous.

They claim it’s because Boston Scientific didn’t tell their state’s constituents about defective defibrillators. Well, duh. A few doctors brought the story to the New York Times in 2005. Guidant had to fess up. And they had to pay at least $195 million for their sins.

But that wasn’t enough. Especially when your legal department is in need of much-needed cash. And lawyers know a bleeding cash cow when they see it. It seems Illinois was one such money-grubbing state:
As part of the settlement, Illinois Attorney General Lisa Madigan said Boston Scientific subsidiary Guidant Corp. has agreed to put in place safety programs and do first-ever public reporting of problems in the devices Guidant manufacturers.

The settlement would resolve a lawsuit Madigan filed Thursday in Sangamon County Circuit Court. She has asked Circuit Judge Patrick Londrigan to approve a proposed consent decree.
Fact: such a reporting system already exists. Additional monies are not required for this.

But it’s interesting to see where Illinois’ share of the $16.75 million payout by Boston Scientific will go:
The $605,000 for Illinois will reimburse the attorney general's office for costs associated with the investigation, said Debbie Hagan, chief of Madigan's consumer-protection division.
You don’t say? Not to the patients?
But Hagan said the settlement is most important because it establishes public reporting of defects and other safety measures - including an independent patient-safety advisory board - affecting one of the world's largest makers of implanted defibrillators.

"This is what we think is going to move the market along," she said. "We have brought physicians and the public into watching this process."
But Missouri’s press release tells the real story: that of the $16.75 million paid out to 35 states, only $1 million will go toward helping a few patients with reimbursement costs beyond the already-negotiated $2500 reimbursement amount:
Under the settlement with the Attorneys General, the warranty program will be extended for an additional six months, and the states will use up to $1 million from Guidant to reimburse warranty participants for expenses beyond $2,500.
So in reality, $15.75 million of Boston Scientific’s payout is for the lawyers’ time for their paperwork to submit the suit – a “pay us or we’ll sue even more” settlement, I guess. And the patients and the public get little in return above what has already been established. Given how little is returned to the patients affected, our legal system should be embarrassed instead of gloating about their achievements in press releases.

But at least our patients can expect higher prices for future defibrillator models to offset these predatory suits.

It seems Illinois’ Ms. Hagan and our Attorneys General are helping themselves and the legal market much more than their constituents or our health care system.

-Wes

Image credit.