Wednesday, December 27, 2006

As The Sun Sets on 2006

As the sun sets on 2006, I hope all my faithful readers and fellow bloggers have a wonderful New Year.

I'll be away for a bit on a much-needed vacation so posts may not be as frequent. Internet access there is limited, I'm told. ;)

Happy New Year!

-Wes

Photo credit.

Motion-powered Pacemaker?

Borrowing a page from Rolex watches and hybrid cars, a new pacemaker is under development that uses the patient's own movement to power its output.

I pity the medical student that has to stand by the patient's side and jiggle the device under the patient's skin during a prolonged intensive care stay.

-Wes

Photo credit.

Tuesday, December 26, 2006

Advanced Medicine for the Advancing Aged


While performing a pacemaker implantation today, I asked for DeBakey forceps (seen above) today – forceps named after an iconic figure in cardiothoracic surgery, Dr. Michael E. DeBakey who underwent an operation at the tender age of 97 that he devised to correct a dissecting aortic aneurism. Although the article that appeared yesterday in the New York Times (and again today in the Chicago Tribune) seemed somewhat apologetic regarding the number of resources used, it nonetheless was a reminder of the incredible capabilities of our health care system when it works the way it should. Gratefully for his family, colleagues and friends, Dr. DeBakey made it through the ordeal in what can only be considered a miracle of modern medicine. Certainly the hard work by all of those involved in his care should not go unacknowledged.

But the bigger story beneath this story is a more subliminal and troubling one: just because care can be delivered, should it be delivered to someone at such an advanced age, in such an abysmal condition with such low probability of surviving to discharge? Circumstances in hind-sight would suggest they should. But in the best of circumstances, a healthy 97-year old male in the United States has about a 2.8 to 3.0 year actuarial survival. Now take a ninety-seven year-old with a Stanford Class A, Debakey subclass II, dissecting ascending aortic aneurism which is leaking into the pericardium who is unconcious and near death - well this individual has a much, much lower probability of surviving the surgery, let alone surviving to discharge. And after the surgery, rehabilitating a ninety-seven year-old is an expensive and arduous undertaking. As a doctor practicing in Chicago, I have to ask myself honestly an important question: would I have proceeded along the same course in a patient with a clear “do not resuscitate” order on his chart that demonstrated such a reluctance to proceed with surgery in the first place?

At this time of shrinking resources in health care, physicians are increasingly pressured to ponder such decisions. These decisions are never made lightly. There was a lot of emotion tied to Dr. Debakey’s illness – he mentored many of the colleagues involved in his care. The irony of the affliction was not lost on those caring for him either. They wrestled with the decision to perform surgery, and only when the wife barged into the meeting room, did they decide to proceed.

But Methodist Heart is also a public “non-profit” charitable organization. Money from the institution went to Mr. BeBakey’s care and will likely be itemized under “charitable care” when their income tax Form 990 is filed for 2006. The organization has authority to authorize funds for such care. But with the growing number of uninsured, ever-increasing costs of providing such health and rehabilitative care coupled with the aging of the population, especially the numbers of patients over 90 years of age, who will decide if John Q. Public gets a full court press or more conservative therapy? When such precedents are set, can we continue to turn our cheek to other younger patients with better chances of long-term survival and similarly difficult-to-manage illnesses? Will this level of aggressive care now become the de facto standard of care for all of our patient’s over 90 years of age? Should it? Certainly there were others in Houston with similar concerns.

Hopefully, there not be hard and fast rules guiding us in these circumstances. But while I commend the spectacular care that Dr. DeBakey received, I do so with some trepidation regarding the solvency of our health care system: especially as it pertains to our younger patients in the years ahead.

-Wes

Grand Rounds End-of-the-Year Round-Up

Medical Bloggers' Grand Rounds Volume 3.14 is hosted today by its creator, Nick Genes, MD over at Blogborygmi. Happy reading!

-Wes

Sunday, December 24, 2006

Lest We Forget

This message was sent to me today and warrants viewing, lest we forget. (Flash player is required)

-Wes

Christmas Carols for the DSM-IV

On a much lighter note, check out the Christmas Carols for the DSM-IV over at Respectful Insolence - too funny.

-Wes

Christmas Reality

Why is it that when a holiday comes about, there always seems to be come new strain of virus that decides to take up residence in my respiratory tract and multiply vociferously? I feel like a Petri dish for viral contagion, with my nose running, post-nasal drip, and low-grade fever. And my looks are egregious, as if Santa had tapped me on the shoulder and said, “You’re on for guiding the sleigh tonight.” And while these looks might engender some vote of sympathy by some, I can assure you that my wife, host to a hundred hungry mouths this holiday weekend, thinks otherwise.

But tonight, these problems seem trivial. Tonight, while driving back from my in-laws’ house, I realized that not everyone thinks Christmas is such a great time. For many, this is the toughest of seasons. For me, the realization came from not one thing, really, but a series of stories and events that transpired recently – all part of the human condition – all moving.

For one family, it was the challenge of recalling the loss of their teenage son years before the day after Christmas – dying of a well-known and under-appreciated disease for its lethal potential: asthma. Christmas holds a different meaning to this mother each year. Each year at Christmas, she reflects on her trip to the morgue to identify her son. She recalls the tender words from her father who accompanied her on that trip. He mentioned to her that might that even the horrors of the war he had experienced years before were easier for him to cope with than that trip to the morgue. It seemed to her at the time that this man, her father, was the only one who understood the incredible sense of loss that day. He got it. So this Christmas she will see her father again to re-live his words and support. I hope and pray she finds comfort once again.

For another family, it is the irreversible and irreparable course of cancer that brings their family together tonight to share what will likely be their father’s last Christmas. It was just several days ago that I learned of the daughter’s attempt to remove a portion of the tumor from her father’s face after doctors said there was little that could be done. Afterward, her father asked, “did you get all of it?” To which she had to reply, “No, Dad, I didn’t.” But she tried to do what she could out of love and caring for her father. Who could blame her? Heart-wrenching. But through this, she came to grips with the situation – its inevitability and all – and has gained an amazing amount of emotional fortitude. Tonight she is the one organizing the dinner, she is the one at his side to help her father and mother. Guiding, caring, loving. She will never regret this path she has chosen to help her parents through. I hope this season brings her some comfort during these trying times.

And finally, I learned of a fall of my own father that resulted in a large gash to his face and multiple stitches. It was a simple event – he was just trying to let out his dog early this morning – but too weak to open the sliding door of his living room adequately, the dog burst into the house through an all-too-small opening, sending my father face-first into a table beside the door. “We didn’t want to bother you,” I was told. And I realized that this battle goes on daily – the challenges of walking, bathing, showering, eating – all have become difficult. Bit by bit, challenge by challenge, life continues. Life is hard. It is what it is. But many, many people do not have the privilege to get old and see their children, to share a meal, a song, another Christmas together. I look forward to seeing him this Christmas, too, stitches and all.

So for all of the others out there with similar difficult and trying times this holiday season, take heart. You are not alone. Many, many others are making it through, bit by bit, hour by hour, day by day. I hope that the peace of God be with each of you this holiday season. Enjoy where you can, and where it’s tough, reflect, and savor it all – for it is all in God’s grand plan.

“… And so, I offer you this simple phrase,
To kids, from one to ninety-two,
Although it’s been said, many times, many ways,
Merry Christmas to you.”

-Wes

Thursday, December 21, 2006

The Dawn of the Food Narcs

As food bans spread rapidly across the country in the interest of public health, one is left wondering how they will be monitored. With the multiplicity of difficult public health issues before us, it seems that governments nationwide have found a new way to deflect more pressing issues by implementing food bans – and there is a willing cadre of starry-eyed idealists standing by to assist. The dawn of the Food Narcs is upon us.

Some of you might not be aware that Chicago has banned foie gras from our local eating establishments by an ordinance passed by the ever-public-minded Chicago City Council. Since this is difficult to enforce, the overstretched city is relying upon – guess who: concerned citizens. And, indeed, nine restaurants have been warned because people dining at adjoining tables, in their psychologic delicacy, have filed complaints with the city. These offending restaurants, “believed” to have served fois gras, according to the Chicago Tribune, were sent warning letters from the Chicago Department of Public Health after receiving a citizen complaint. A visit by the Department of Public Health occurs after a second citizen complaint, and visits that turn up evidence of the banished dish can result in fines of $250-$500.

While multiple large companies have moved to ban trans fats from their recipes, will other smaller companies risk litigation by not following suit? Certainly the Big Boys will be under careful scrutiny by the legal community because they have deep pockets. But what of the little guy? Who will be overseeing the corner hotdog stand to assure they’re serving trans fat free bagels? Now we know who: fellow community-minded citizens. Isn’t it reassuring to know that if you cannot control yourself, or are victimized by making politically incorrect choices, others will be there to save you from your own behavior?

If people cannot be responsible for behaving correctly, then perhaps the only alternative is for other citizens to monitor them. Maybe they can be sent to food reconditioning camps – Chairman Mao anyone?

-Wes

Wednesday, December 20, 2006

A Christmas Card to UnitedHealth

Dear UnitedHealth,

Here's wishing you a very Merry Christmas and Happy Hannukah. May the spirit of Christmas remain in your heart as your profits soar.

Your guiding principles remain a true wonder in this season of frugality in health care. Your incredible ability to forecast another stellar year of profits (14%) amid growing health care costs to employers and patients is stunning. We, your shareholders, are breathing a big sigh of relief, especially amid all of the current buzz regarding the ethical practices (*cough*) that have been transpired with all of the options backdating and accounting oversights this year.
UnitedHealth forecast 2007 net income in a range of $4.7 billion to $4.75 billion on revenue of about $79.5 billion. The company also backed its 2006 profit target, pegged in a range of $4.14 billion to $4.16 billion. These forecasts, UnitedHealth said, are based on expectations for "gains from increasing market share and strong operating margins" across its business units. In addition, the company targeted operating cash flow at about $6 billion to $6.2 billion next year.
We know that doctors really appreciate your "margins" of health care coverage each time their patients open their "Explanation of Benefits" letters and have to pay progressively larger portions of their health care bill on top of their premiums to feed our beast. Thank you.

As the challenges to health care grow, we are thrilled to offer you wishes for a "very prosperous New Year" next year (*cough *). Now that Medicare has agreed to have doctors kick in 1.5% of their earnings to provide best practices data for you to reap higher profits, you should be perfectly situated to have an even better year in 2008. Keep up the good work.

Oh, please tell your Chief Executive Stephen Hemsley to stop calling those little oversights "embarrassing." I mean, your actions speak louder than words. Ho ho ho!

Have a wonderful holiday season!

- Johnny Shareholder

Tuesday, December 19, 2006

Monday, December 18, 2006

Puzzle Whiz Dies of Sudden Death

Michael Mepham who wrote most of the crossword, word scrambles, sudokus for the past 25 yrs... died of sudden death last week in England. Gamers everywhere are mourning his death. More details can be found on his sudoku forum here.

Hat tip: David Najman, MD

Who's The Man?

It seems that Time Magazine has decided you (and everyone who accesses or provides content for the Internet) are, indeed, their Man of the Year.
“For seizing the reins of the global media, for founding and framing the new digital democracy, for working for nothing and beating the pros at their own game, Time's Person of the Year for 2006 is you,'' staff writer Lev Grossman wrote in the cover story.
Perhaps the blogging community is receiving this award from Time Magazine with measured tone because of something we bloggers already know. Just as the Internet has equalized the playing field in the media, we might consider a different hero next year.

I would suggest that the Luddites, those contemporary opponents of technological change, take the prize next year. Like Thoreau, they are the ones who keep things in perspective. After all, they are the ones who serve as a balance to the fulcrum of a world going chaotic. The electronic leash has its own downside: the seeming urgency of dispatches from the Blackberry, the hours spent in virtual community rather than family. We might just find that the technophobes hold the balance for a world that thinks it is more substantive than it really is.

-Wes

Sunday, December 17, 2006

Another Chistmas Meme-ory

Thanks(?) to Rob over at Musings of a Distractible Mind for his tag regarding this Christmas meme which has been circulating a while... It's fun to play along...

1. Hot Chocolate or Egg Nog?
Well, the nod goes to the Nog, at least in limited amounts – it reminds me of the season. And I have this thing about dying from something I understand

2. Does Santa wrap presents or just sit them under the tree?
Huh? Wrapped, of course! Special ‘North Pole’ wrap.

3. Colored lights on tree/house or white?
Honestly, I had always done white on the house, but his year I noticed just too many houses that way, and went to the multi-colored variety and love it! I climbed thirty feet up a ladder in a death-defying exhibition of idiocy that provided wonderful entertainment for the neighbors – I noticed them watching me like they were waiting for the big car crash at a NASCAR race… but I survived. (Maybe next year I’ll hire someone to do this…) The tree has been and always will be multi-colored.

4. Do you hang mistletoe?
No. I’m over that. I mean, when you have a Cadillac in the garage, why go after a Ford?

5. When do you put your decorations up?
We never put them up before 1 December. Thanksgiving is important in our house.

6. What is your favorite holiday dish?
I make a mean Buche de Noel.

7. Favorite Holiday memory?
Santa always had a unique way to expose the last present. A small card on the tree attached to an ornament would have a limerick to take you to the next limerick, then the next limerick, then another, until 5 or 6 poems later, the final resting place of the present would be exposed. Or other times there would be a long string attached that would wind around the entire house! The anticipation was incredible!

8. When and how did you learn the truth about Santa?
What truth? Santa still comes every year, one way or another…

9. Do you open a gift on Christmas Eve?
Only one is permitted, after we attend church.

10. How do you decorate your Christmas Tree?
Carefully, except for this year when we experienced Christmas Tree Syncope.

11. Snow! Love it or Dread it?
Love it! I mean, what’s better than a White Christmas?

12. Can you ice skate?
Sure, but my ankles usually pay a price.

13. Do you remember your favorite gift?
I remembered it every year, until the next year, when another magic gift arrived.

14. What’s the most important thing?
Family and our faith in God.

15. What is your favorite Holiday Dessert?
See number 6.

16. What is your favorite holiday tradition?
Each Christmas Eve, luminary are lit in our neighborhood up and down blocks and blocks just after dusk. The drive to church sends chills down your spine.

17. What tops your tree?
An angel that my daughter places there after she climbs on my shoulders.

18. Which do you prefer giving or receiving?
My mother always said, and I agree, “The gift of giving is with the giver.”

19. What is your favorite Christmas Song?
Oh Holy Night.

20. Candy canes, Yuck or Yum?
Yum, baby, yum. I can only do one small one a day at most, though.

Now, whom to tag?

Dr. K at That Mirror Belongs to Frank,

Dr Couz at Tales from the Emergency Room and Beyond, and

OB/Gyn Kenobi.

-Wes

Saturday, December 16, 2006

Waistlines with Helplines

A recommendation by European metabolic researchers to place obesity helpline numbers on clothes for fat people appeared yesterday and caught my attention in part due to the concerns of obesity in England, but mainly due the discriminatory nature of the labels. To me, it is yet another example of government and academics overreaching into the private lives of our patients. Unfortunately, with the world-wide distribution of these stories, it is frightening to think that other government officials might think this is a good idea. With this logic, why stop with labels for the obese? Why not place labels appear on the flies of trousers or the thongs sold at Victoria's Secret that say, "Promiscuity is a high risk behavior and could kill you." Or why not put a warning label inside baseball jerseys that says "Excessive beer consumption can be hazardous to your health?" And staying completely mundane, when was the last time you read your pant or shirt label anyway?

Will such labels change eating behaviors? Doubtful.

I have never met an obese individual who didn't know they were obese. Many of them have very real reasons they are obese, including psychosocial issues that are far more resistant to intervention that any warning label will correct. Some of these people are unhappy, others are indifferent, others eat for nurturance, for others it is a compulsion. Others are just exasperated at their inability to gain control over their situation. Whatever the root cause, the psychodynamics of obesity are too complicated to be solved with garment labels. Do we really think government intervention with "labels" will solve these deep seated and very personal issues? On the contrary, these labels might reinforce the very negative perceptions they intend to help, catalyzing the compulsion still further.

Personal responsibility and real medical and social interventions are needed to battle the obesity epidemic. Socioeconomic stressors also play a significant role. Only improved awareness, education, increased physical education and support programs paired with regular physician follow-up will help guide people to lifestyle modifications that will insure a safe, long-term solution to this problem. There is no quick fix.

Significant challenges lie ahead for governments and healthcare providers dealing with the obese. For starters, few individuals see mild or even moderate obesity as a health issue - after all, most of us chubby soles feel fine. We (doctors and educators) have done a poor job educating the population regarding what's good and what's bad: mixed messages abound. We make deamons of trans fats, saturated fats, high-sugar content foods, creams, Oreo cookies, and on, and on, and on, while placing soda machines in our schools and feeding high carbohydrate junk at lunchtime in schools. Exercise, although touted, is seldom granted time to perform in workplaces fixated on productivity. The relentless buzz regarding low-carbohydrate diets, sugar-free diets, and others becomes background noise: blah, blah, blah. They've heard it all, and nothing works for them.

But there are success stories. Some people really do lose weight. Some really do lose their diabetes, hypertension, and chronically painful joints. But most of these successes are due to active intervention by family members, caregivers, and a healthy dose of self-realization of one's situation. Pants labels just aren't in the mix here. Only when each of us takes responsibility, doctors and patients alike, will there be success in this war on fat.

-Wes

Friday, December 15, 2006

Medical Error Gets Stiff Reception

Funny. It seems it didn't take long for this medical error to 'raise' the attention of some smokers in Scotland.

I just wonder who complained?

-Wes

Thursday, December 14, 2006

You Are Christmas

To all the caregivers
Who make Christmas happen
Even when their hearts are heavy
Moments of rest too few…

You are Christmas.

To all the suffering
Who rise to the occasion
With a smile or a simple gift
Or permission for others
To celebrate without them…

You are Christmas.

To all the doctors and nurses and hospice workers
Whose own trees go undecorated and gifts go unsent
Because it seems every year
The hospitals are full at holiday time…

You are Christmas.

To all the parents
Who recapture the innocence of the season
For the sake of their children
With a song, a story, a silly ritual…

You are Christmas.

It was never about the strong, the shiny, the rich,
The loud,
It was always about the humble, the faithful, the courageous,
The quiet, hopeful ones.

- Diane and Wes

Wednesday, December 13, 2006

The Dark Side of Pay for Performance

The pay-for-performance nerds are in a tailspin.

Yesterday’s JAMA article, co-authored by Drs. Rachael Werner and Eric Bradlow, compared the World’s Best Hospitals (top “75th percentile”) to Johnny Q Public hospital (bottom 25th) and found that, gee, people die at about the same rate at hospitals in the US. Amazing. But what was beautiful about this study, was the data mining of the data came from The Centers for Medicare and Medicaid Services (CMS)’s own Hospital Compare website. Hospital performance measures that were supposed to ferret out the good boys from the bad boys were found to be crummy measures and only predicted small differences in hospital risk-adjusted mortality rates.

But to the quality nerds that want to use such statistics to form pay incentives for physicians and hospitals, this presents a dilemma. What do you do when everyone does a good job? Or, as the quality nerds would like to say, what do you do everyone in the United States is performing in the same mediocre fashion?

Why, it’s easy! Make more measures! The quality nerds responded:
… Michael Rapp, director of CMS's quality measurement and health assessment group, said the researchers most likely would have found bigger differences between hospitals if they'd examined all 22 quality measures used on Hospital Compare. Finding only slight differences when using a few measures is not surprising, Rapp said.
Whoa there, Mr. Rapp. If I have a heart condition and want to find out about the World’s Best Hospital caring for heart disease, why do I need 21 or more other measures? But I know how you will clarify it for me:
Still, Rapp said he agrees that more quality measures are needed to evaluate hospitals. "CMS is actively working to expand quality measures used on Hospital Compare," Rapp said.
Please, Mr. Rapp, give me more data do I can be even more confused. Give our patients more measure to make this “clear.” If the public can’t figure out Medicare Part D, how the heck are they going to decipher the 22 measures you already have, or 100, 200, or even 1000 measures? Is this how we're going to give “power to the people?”

While carefully-controlled drug trials have demonstrated the effectiveness of aspirin or a beta-blocker therapies at reducing mortality after a heart attack, to suggest that measuring compliance with a medical regimen will translate to improved patient mortality outcomes after heart attack in the uncontrolled real world is a leap. Patients are not homogenously selected like they are for such trials. Every patient is unique and every patient’s problem list different. Medicine is complicated, not cookbook.

When a good researcher stops and wonders why his experiment failed, he gains valuable information to steer him in the right direction to test his next hypothesis. CMS does not seem capable of this. Rather, their answer is to develop still more convoluted “measures” rather than focusing on other, more urgent matters that might save the health care system.

I would suggest that CMS cut costs by focusing stricter guidelines for insurers dealing with Medicare patients by restricting overpaid insurance CEO’s and board members and require liability reform nationwide for any state desiring Medicare or Medicaid funds, rather than leaving the insurance, regulatory and legal interests to cripple our health care system further and price our patients out of the health care market.

You see, measuring performance measures by its very nature has a more sinister side, especially if one gets the evaluation measure wrong. Tacitly stated, measuring “performance” differentials implies one must also measure ”non-performance.” And you might as well call it “incompetence.” Doctors, hospital administrators, and people in general don’t like being called, or even considered, incompetent - especially by a governmental body that demonstrates its own inability to get the measure(s) right.

-Wes

Tuesday, December 12, 2006

Christmas Tree Syncope

This time of year can be a frustrating one for doctors and their families. Oh, heck, it can be frustrating for just about anyone, I guess. But I have found an unusual incidence of problems with decorating my house this year. It’s like negative Karma, a decidedly un-Christian experience, has descended upon our household.

Why, for instance, does the garland I draped with little white lights and saved carefully in an airtight container from last year, decide to have only one half of the lights on the garland strand light? Why is that? And have you ever tried to fix one of those “half strands” of extinguished lights? You go over and grab one of the extra little bulbs attached to the string of lights and find the one bulb that isn’t stained with red (those red ones make that God-forsaken blinking). Now, you try to play hide-n-go seek with 75 other bulbs on the strand to find the one that is out in hopes of resuscitating the strand. It ain’t gonna happen. Trust me, I’ve tried. So why do they include those stupid little bulbs, anyway?

My wife suggested the miniscule fuse also attached to the end of another string of lights might fix another strand. Have you ever tried to place the fuse inside the plug? Usually you need a set of forceps and a loop microscope to identify the old fuse and extract it. Damn thing looks like one of the inner ear bones, but I digress. Anyway, you put that fuse in the plug and well, it still doesn’t work. Don’t ask me why. Finally, after saying enough expletives to fill a dictionary, I gave up. I went to Walgreens tonight to just buy some new strands.

And of course, Walgreens is all out of the little white lights. Oh, I could have all red, all blue, all green, or all multicolored, but the little white ones? They’re all out. They’re hanging on everyone else’s trees and bushes.

But three other stops later at other stores, I found a few short white strands, brought them home, and plugged them in and all fared well. One problem conquered.

But another was about to develop.

Last weekend I was on call. I hate call. But it’s a necessary evil.

But my wife hates my call weekend worse than I do, especially this time of year. There’s so much to accomplish that the last thing she needs is her husband off “saving lives” while she saves the family. This weekend was especially difficult, so she decided to act unilaterally and get the Christmas tree without me. She thought she would surprise me.

So when I came home later that evening, there is was, leaning a bit, but adorned with all of the beautiful multicolored lights and special garland. She and my daughter were so proud. They had managed to place it in an old tree stand next to our front window. Very festive, indeed, and a wonderful gift for me to see it up without having to wrestle with that sucker this year! Wonderful!

So the whole family decorated the tree with our heirloom ornaments and remembrances. It was all such a Norman Rockwell painting. Christmas music rang through the air, it was cool outside, the fire was going in the fireplace, and you could here the family decompressing:

Oh the weather outside is frightful
But the fire is so delightful
And since we've no place to go
Let It Snow! Let It Snow! Let It Snow!


After we had finished, we each went to our ways, and I decided to sit and check my e-mail. Little did I know our tree had fallen ill.

There was no warning. No time to react. Yep. Fallen ill. It couldn’t, wouldn’t, shouldn’t be, but was: Christmas tree syncope right there in our living room. The entire behemoth came crashing down, with 30-40 ornaments smashed to smithereens. Countless others rolling across the floor. Sadly, my son’s special ornament pulverized into little red and silver shards.

My wife and I looked at each other. No words were spoken, but the tacit message I could hear was, “If you say one word after I put up with all this crap today, you better not say a (*$%)( thing.” An hour later we found ourselves positioned, smily-faced at yet another Christmas cocktail party.

Ho, ho, ho.

Well, I’m off to pen one of those rosy, Pollyanna, “My Family is so Perfect,” Christmas letters…

-Wes

New CPR Guidelines - Better?

Boy, I'm not sure I agree with the new recommendations put forth today by the American Heart Association regarding more manual compressions before delivering a defibrillation during Cardiopulmonary Resuscitation (CPR):
The old guidelines called for repeated shocks along with a pulse check before administering CPR. The new way endorses a single shock followed by two minutes of CPR, the Heart Association said.
In the EP lab where we witness cardiac arrest and all of its excitement first-hand, there is NO QUESTION that early defibrillation works. I have had times where one shock is not enough to resuscitate a patient in our lab setting. If I stopped to first perform CPR before shocking one of my patients during witnessed cardiac arrest, I am sure we would have a higher complication rate in our laboratory. Many of our patients have ischemic coronary disease, and when the heart fibrillates, no effective blood flow is pumped from the heart, cuasing it to be more susceptible to ventricular fibrillation, not less.

I suppose in patients who have collapsed for a while, there might be logic in the AHA's recommendations - circulate a bit of oxygenated blood to the heart first, then try shocking. But certainly in witnessed cardiac arrest, I'm going to shock them more than once every time.

-Wes

Medical Blogging Grand Rounds is Up

... over at Anxiety, Addiction, and Depression Treatments blog.
... it was six months and over 400 posts ago that we last hosted Grand Rounds. It's surprising how much has changed in that time, but also how much has stayed the same. We had a number of submissions from bloggers we featured last time around, along with a number of new faces. It seemed too that the quality of blogging has only continued to rise. Maybe it's simply a factor of writers becoming more comfortable with the medium. Or maybe it's a function of medical bloggers pushing each other to excel. Whatever it is, one thing is for sure: we the readers are the ones who truly benefit.
Enjoy!

-Wes

Monday, December 11, 2006

Another Biodegradable Stent Debuts

And just when the cardiovascular surgeons thought they might wrestle back the coronary revascularization business, a new completely bioabsorbable coronary stent released its first early clinical results today. This stent is produced by Bioabsorbable Vascular Solutions, Inc. (BVS), a Guidant (now Boston Scientific spun off to Abbott Vascular during the earlier Guidant acquisition by Boston Scientific):
The new BVS stent is made of a polymer that dissolves into lactic acid over two to three years. Lactic acid is a naturally occurring substance in the body, produced after exercise. It breaks down into carbon dioxide and water, and is absorbed by the body.
Unlike earlier bioabsorbable coatings over a bare metal stent, like the earlier Biomatrix stent, no bare metal exists in this stent. Of note, the stent also contains everolimus, and elutes this drug over an estimated 120 days. These patients are part of the ABSORB clinical trial enrolling up to 60 patients in Belgium, Australia, Denmark, France, the Netherlands, New Zealand, and Poland. While the initial results seem promising, there are a few caveats worth mentioning:
  • These stents have no long-term track record and have not yet begun trials in the US, to my knowledge, but the international experience will form a basis to begin the first US trials, if successful.

  • The stents will have an initial inflammatory reaction after implantation since the polymer is a foreign body. As such it is still subject to restenosis, though the everolimus should help reduce this inflammatory response.

  • It should have better imaging in MRI scans and CT scans since the polymer will not cause the reflectance artifact like metal stents.

  • While the absorbable nature of the stent is intriguing, the mechanism of late-stent thrombosis is unknown, so long-term studies on anti-platelet agents will still be needed, especially since the stent is drug-eluting for only 120 days of its 2-3 year existence in the coronary artery. It's just too early to claim that these new stents will reduce in-stent late thrombosis risk yet.
Nonetheless, it is refreshing to see some new news on the coronary stent front that might make the debate between bare- and drug-eluting metal stents a mute one.

-Wes

Sunday, December 10, 2006

Doctor Medicare Payments Preserved - With a Catch


At the last minute, like the Grinch Who Stole Christmas and later repented, Congress's proposed 5% Medicare payment cuts were spared, in part due to a strong push by physician advocacy groups. To be reported in tomorrow's Wall Street Journal (subscription):
Congress agreed to erase a scheduled reduction in payments to physicians, but it made a 1.5% bonus payment available only to physicians who report to Medicare how they perform on certain specified barometers of health-care quality. Initially, the payments will be based on whether the physician reports the data, but the system lays the groundwork for higher payments to better-performing physicians.

Among the information Medicare officials will collect: whether doctors provide aspirin and beta blockers to patients having heart attacks, and whether elderly patients are screened for their risk of falls. These practices are considered indicators of good patient care.

Hospitals, too, will have greater responsibility for reporting quality-of-care data. While most hospitals already have been doing quality reporting on inpatient care, the new legislation requires them to do so for outpatient services to receive the full payment scheduled under law for those services. Congress added an additional wrinkle to the program in the latest legislation, requiring the Department of Health and Human Services to consider ways that the hospital data could be made available to the public.
The implication of this bribery for reporting is significant, since it establishes a measly 1.5% premium on "Pay for Performance" - hardly a robust incentive. For instance, for a 20-minute outpatient follow-up visit that averages a $54 dollar Medicare reimbursement, Medicare is willing to pay an additional $0.81 for us to submit data about the drugs we give the patient. Since the payment isn't enough to offset the cost in man-hours to supply the data, will the data be complete or accurate?

And I hope they realize that not ALL patients with heart disease can take aspirin (due to allergies) or beta blockers (like patients with severe lung disease) after a heart attack. Will we be paid to "perform" when we fail to treat patients with these drugs in such circumstances?

Unlikely.

-Wes

Lawyers' Feeding Frenzy

An now the real reason the trans fat ban exists in New York.

Lawyers, it seems, have struck gold:
"Fat may well be the next tobacco, and trans fat is likely to be one of the most promising targets, because it's so dangerous and totally unnecessary, and because there are so many legal theories under which it can attacked," says law professor John Banzhaf who helped lead the movement to sue cigarette manufacturers, and started the anti-obesity litigation movement.
For lawyers it seems, it's not about health, it's about the money: over $24.5 million and counting ... look for more of them to join the feeding frenzy.

-Wes

Friday, December 08, 2006

Off Label Stents Equals One Year Aspirin and Plavix

From MedPageToday:
The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.
This is a reasonable recommendation based on the paucity of data that exists to date. Look for new package inserts and for cardiologists contining their current treatments. Once formal recommendations are issued, some big trials like the SYNTAX trial, which compares stent therapy to cardiac bypass surgery for three-vessel and left main coronary disease, might need to change their consent forms and duration of clopidogrel (Plavix) therapy in the stent-treated arm.

For patients with drug-eluting stents, be sure to check with your doctor if additional Plavix and aspirin therapy are warranted in your case. Here is the FDA's "on-label" use for Boston Scientific's TAXUS stent (pdf file):
The TAXUS Express 2 Paclitaxel-Etuting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions < 28mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter.
And for Cordis' Cypher stent (pdf file):
The CYPHER® Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.
Your doctor can help you sort this out and most patients will be just fine, but some may need slightly longer anti-platelet therapy with aspirin and clopidogrel (Plavix).

-Wes

So Much For the Trans Fat Ban



One Arizona restaurant's answer to New York's trans fat ban.

This should serve as a dose of reality as to the ban's effectiveness nationwide.

-Wes

FDA Panel Adds Little to Stent Discussion – So Far

The big expensive panel convened to decipher the risks of drug-eluting versus bare metal stents, has so far done little to clarify issues regarding management of patients with drug eluting stents for cardiologists. So far, the meeting seems more like a PR meeting to reassure the public that industry-sponsored experts are confident in the safety of stents.

Cardiologists already know this. In days of old before drug-eluting stents, cardiothoracic surgeons were still pretty busy helping to manage patients who would return with re-narrowing (re-stenosis) of their bare metal stents after cardiologists could do little to intervene. But now, cardiothoracic surgeons are busy finding other things to do, like atrial fibrillation ablations, since multi-vessel angioplasty and stenting has become commonplace due to the effectiveness of drug-eluting stents. Cardiologists have pushed the indications beyond treatment of simple vessel narrowings, tackling branch-vessel narrowings that are much more complicated. In fact, the FDA estimates that 60% of these devices are used outside manufacturers’ labeling.

What cardiologists want to know (and other doctors who manage these patients) are management issues: in what situations should a patient NOT receive a drug-eluting stent? Should these stents be used in off-label complicated branch-vessels in an off-label, side-by-side fashion known to be higher risk for clotting? How long do patients need clopidogrel (Plavix)? What do we do with patients who require surgery and have drug-eluting stents to minimize their risk of in-stent thrombosis?

Instead we were treated yesterday to a feel-good session on the safely of stents by cardiologists who receive (either personally or for their institution) significant funds from the stent manufacturers.

While it is good to allay the concerns of the millions of people out there with drug-eluting stents, I hope we get to hear more “meat” today about management and follow-up of our patients, or at least, about plans to organize prospective trials to address some of these questions.

-Wes

Thursday, December 07, 2006

When Insurers Rate Doctors

Beginning in January 2007, Blue Cross Blue Shield of Texas will post online indicators for Texas physicians regarding "guideline performance" and "affordability" called "BlueCompare":
BlueCompare is a program developed by Blue Cross and Blue Shield of Texas to enable more informed health care decisions by consumers.
Oh, but don't worry:
This information is provided to assist you in selecting a health care provider. It is not intended to be a recommendation. (emphasis mine - wait, are you "assisting" or "recommending?") Your selection is a personal choice, and you should not base your decision solely on Affordability or Evidence Based Medicine (EBM) Indicators.
Not a recommendation? Oh, pleeeeze! What else do you call it? A suggestion?

Worst of all Blue Cross offers no mechanism to determine if their "EBM's" are accurate, nor are they verifiable. Where do these data come from? Most insurer personnel I know don't have a CLUE about medicine. Yesterday, I spent over an hour on the phone trying to get a test paid for by XYZ insurer because the screening personnel didn't know the difference between a vein and an artery. Bozos all.

And how often will these "website doctor thingamabobs" be updated? If I were a doctor in Texas (and no doubt this trend will spread), I would want to know the methodology and update frequency of this site. We doctors recognize that these indicators/suggestions/recommendations have NOTHING to do with the care provided by doctors (although they sure imply it), rather they only measure the documentation of the care provided.

But why should anyone care?

Because to not understand methodologies and verifiabity of this data subjects Blue Cross to potential charges of slander against doctors in whom data are misrepresented. And even worse, when a patient with chest pain goes across town in Houston to see a "more affordable" doctor and dies en route due to delayed therapy, there might just be hell to pay.

-Wes

Christmas Gifts

It’s been a busy period here, so the blogging has been a bit sparce recently, sorry.

I have been thinking about Christmas gifts for our staff this year. They’re the ones who spend countless hours getting charts ready and arranging the little logistics that make such a difference to the overall patient experience. I feel it’s important to acknowledge all of their efforts over the past year. But then I saw how Chicago’s Mayor Daley does his gift-giving a holiday time:
A memorandum sent out last month on city stationery asks department heads and senior staffers to give a "$35 voluntary donation (no checks please)" toward a gift for Mayor Richard Daley and his wife, Maggie.
Seems that’s how things get done here in Chicago.

The article goes on to say that past years they have bought a salt water aquarium and a piece of art from China for him. This year’s gift will reportedly be different.
When the Tribune asked what the present would be, mayoral spokeswoman Jodi Kawada revealed Wednesday that a $2300 charitable donation will be made in the Daley’s names. The money will go to After School Matters, a program overseen by Maggie Daley that offers activities for city teenagers.
Seems to me the names of all of the contributors should be mentioned, not the Daleys.

Does anyone else have clever ideas for Christmas gifts for staff?

-Wes

Tuesday, December 05, 2006

Grand Rounds 3.11

Almost forgot, medical bloggers' Grand Rounds is up at The Antidote: Counterspin for Health Care and Health News. Happy reading!

-Wes

On the Trans Fat Ban in NY

"Are we going to start to outlaw what everyone should eat in the city of Chicago? The City Council will be sitting in your kitchen to determine what you should eat on Sunday after church." - Mayor Richard Daley, Chicago
The recently announced and much anticipated ban of trans fats in New York restaurants reminds me of the fois gras ban here in Chicago earlier this year. No one was there to enforce it and it looked like special interests (animal rights activists) got to tie up Chicago legislature with something that meant little to the general population, while ignoring other more pressing public health and safety issues. It was repealed a little over a month after it was signed into law. Will this new trans fat ban spread across the country or will the ban eventually be repealed? Right now, it's tough to know.

Now please understand that I tow the party line: trans fats are bad for you. There, I said it. They raise low density lipoproteins (LDL) and lower high density lipoproteins (HDL or "good cholesterol"). And trans fats are ubiquitous fixtures in our culinary landscape, adding plenty of calories to our diet.

But how many of us really know what fats our foods are cooked in? How many people inquire about this in restaurants? How many know a "good oil" from a "bad oil" in their kitchen? Will it matter to our obesity epidemic? Do you realize those Girl Scout cookies you love each year are cooked in trans fat oils? Will you care when a doe-eyed little girl asks you to purchase her cookies? No, you will purchase them to help her. Will you care if she can't raise funds for her cause selling cookies door to door in New York due to a ban on trans fats? You bet.

But like seat belt requirements in cars, there are occassionally good ideas that come from governmental regulation and legislation. Certainly adding seat belts to cars, and later air bags, has saved countless lives. Perhaps trans fat bannings will lower coronary deaths, but unlike tallying deaths from car accidents, proving cause and effect of heart attacks as they relate to trans fat consumption will be nearly impossible to prove. Will doctors look over the recently deceased in the Emergency Room and say, "Damn, we lost him from a trans fat overdose!" I think not. Dietary intake is just one risk factor for premature coronary deaths.

And most people don't even know the difference between a trans fat and a mono- or polyunsaturated fat. Sorry, they don't. But fat of any kind burns at 9 calories per gram while carbohydrates and protein burn at 4 calories per gram. Eating too many calories (including fat) of any kind means you're still likely to get fat.

But food companies can now pander to the uninformed. Already there are "trans fat free" food labels on your store shelves ... even when food companies still have their foods loaded with TONS of other forms of fats and calories. Another fad is born.

Now I ask you, what has the New York Health Department accomplished, really?

-Wes

FDA and Stents: Bet on Aspirin and Plavix

There seems to be a lot of gnashing of teeth about what to recommend for people who have received drug-eluting stents. Should patients continue the anti-platelet (and hence, anti-clotting) drugs, aspirin and clopidogrel (Plavix) indefinitely? Or should these drugs be stopped sometime after one year?

A big, manufacturer-friendly, FDA “advisory panel” will convene on Thursday and Friday in Gaithersburg, Maryland to discuss this topic and review meta-analyses, anecdotal-isms and retrospective registries. No one will have any prospective, randomized data over many years comparing the risk of clot-formation in stents compared to the risk of bleeding from Plavix and aspirin.

It is important to remember that restenosis of bare metal (non- drug-eluting) stents due to the growth of scar-like tissue (called "neointimal hyperplasia") inside the bare stent was a real problem in patients before drug-eluting stents hit the market. Smaller diameter stents were most likely to develop this complication compared to larger diameter stents. But after drug-eluting stents burst into the market, this problem became much less prevalent. Cardiologists stopped seeing the "frequent fliers" for repeat stenting and no longer performed the more complicated brachytherapy (radiation) to prevent restenosis. Cardiologists aren't stupid: they liked this feature of drug eluting stents.

Unfortunately, over the course of time, it was eventually discovered that drug-eluting stents occassionally clot shortly after the Plavix medication was discontinued. This didn't happen all the time, mind you. It happened about 5 percent of the time. But unlike restenosis of bare metal stents that occurs slowly, the clotting seen after stopping Plavix in a drug-eluting stent is often an abrupt, sudden event leading to much larger heart muscle damage.

It became clear that taken together, Plavix and aspirin are important deterrents to the formation of blood clots in stents. But the long-term risks of life-long Plavix, especially it’s risk for developing later bleeding complications, are unknown. And Plavix is expensive. Many cannot afford the drug and Medicare doesn’t cover the drug unless individuals carry a supplemental drug benefit.

The problem now, in my view, is that there are lots and lots of drug-eluting stents in patients already out there. Stents, once deployed, can’t be removed. And we cannot abandon our patients. So the clot-preventing drugs aspirin and Plavix must be continued for at least a year, or better yet, indefinitely unless the risks of bleeding are excessive.

Also, it would not be surprising if the FDA recommended that larger-diameter stents be bare metal, since restenosis risk is lower in these larger-diameter stents. And look for the advisory panel, in the interest of "safety" to require new stents (and new competitors to the panel's companies they represent) to have to submit "more data," delaying approval of the other companies' stents.

Finally, I would not be surprised if the FDA recommends that a registry be developed to track complications (the FDA loves registries: just look at the recent defibrillator recall fiasco). This might permit a later development of data-based guidelines based on probabilities. One such decision support tool that uses retrospective data has recently been deployed in Kansas.

For the non-cardiologist, issues on how to handle non-cardiovascular surgery in patients on Plavix and aspirin still need to be better defined, but I doubt the panel can cover all of this territory in the short two days ahead.

For now, though, a lot of this will be “flying without instruments.” And the weather is still partly cloudy…

-Wes

Monday, December 04, 2006

Shameless Self-Promotion for a Good Cause

Now for a bit of shameless self-promotion.

My wife just published a podcast for our Medtees website which makes these goofy medical t-shirts that support lots of charities. You can link to the podcast, produced by PRWeb, on this page and see the shirt that I brought her after her thyroidectomy (such a nice husband, huh?).

Or, if you haven't checked out our ABC 7 News (Chicago) spot filmed earlier, you can view it here and listen to the stories from a few of our customers. (Yes, yours truly is in it, too).

Seriously, there are plenty of good causes that these shirts support, including the American Cancer Society, American Lung Association, Heart Rhythm Foundation, Juvenile Diabetes Research Foundation, the American Academy of Orthotics and Prosthetics Project Quantum Leap (for amputees), the Epilepsy Foundation, Crohn's and Colitis Foundation, CHADD (Children and Adults with Attention-Deficit/Hyperactivity Disorder), American Organ Transplantation Association, Arthritis Foundation, etc., etc. We're happy to say that over $1000 has been donated to these charities so far! JDRF has the highest donations, followed closely by the Heart Rhythm Foundation and American Cancer Society in a close race for second place.

International customers have included folks from Canada (eh?), the United Kingdom (the other side of the pond), Australia (Down Under), New Zealand (WAY Down Under), Puerto Rico (Que pasa?), Greece, Finland, the Netherlands, and Argentina so far. International shipping is pretty reasonable: about $7 US.

And yes, we're still soliciting ideas for new shirts. We do ask that the ideas be "kid friendly" (we like to keep our site at least PG-rated) since kids get diseases, too. But if your idea is used, we'll send you the shirt free. You can e-mail me your idea(s) at wes [at] medtees [dot] com. All contributors are acknowledged and get to decide where to direct the funds for their shirt (sorry, only legitimate 501-3c charitable organizations permitted).

So if you know someone that is sick, isolated, or frustrated with their condition, or someone who loves to poke fun at their condition to advocate for their disease, consider one of these shirts. Get them for you, your friends, or your neighbors and help support your favorite charity this holiday season.

Alright, I'll stop.

-Wes

Pacemaker, Defibrillators, and "Killer Magnets"

Bloggers learn to love and hate the media. On one hand they help disseminate information, but when it is done poorly, misinformation can be worse than the news they intend to spread. Such is the case when headlines read like 'Fridge Magents "Can be a killer."'

So what are they talking about? First of all, Johnny Everyman is not likely to be struck down by refrigerator magnets. What clever Swiss researchers (published in the December issue of Heart Rhythm) did is note that when the more powerful, readily-available magnets made from neodynium-iron-boron (NdFeB) magnets of sufficient size (0.8-1.0 cm) are placed within three centimeters of a pacemaker or defibrillator, it can effect a special magnetic switch inherent to all of these devices. Since some jewelry is being manufactured with these strong magnets (and I am aware of newer magnetic name tags that might be placed near the device), then the pacemaker or defibrillator might be affected.

So what happens?

Pacemakers and defibrillators contain a small "reed switch" that is sensitive to magnetic fields that allows patients and their doctors an opportunity to affect their device to perform specific functions outlined below.

In the case of pacemakers, the activated reed switch tells the pacemaker to pace, irrespective of the person's underlying rhythm, at a specific rate (determined by the manufacturer of the pacemaker). When the rate changes, this tells doctors how much voltage is left in the person's pacemaker, and uses the paced rate to act like a battery meter, telling doctors when the pacemaker battery voltage is getting low. It does NOT inhibit pacemaker output. (Oh, there will be some wise guy that says that pacing that does not synchronize with one's heart rhythm could land in the "vulnerable period" of the cardiac cycle and induce an abnormal rhythm (and yes, that can occur), but magnet checks are done tens of thousands of times a day in the US and I have never heard of someone dying from this with conventional pacemakers).

In the case of a defibrillator (that treats abnormally fast and slow heart rhythms), the reed switch acts slightly differently. Again, a magnet over the person's defibrillator does NOT inhibit pacing at all. In the case of a defibrillator, a magnet over the device that is powerful enough to trip its reed switch will suspend detection of rapid heart rhythms while the magnet is over the device. In the case of this article, this will only happen if a magnet is held within three centimeters of the device. That's only 1.5 inches, folks. In other words, one of these fridge magnets or pieces of jewelry would have to be held virtually right over the device to have any effect. Certainly, if the person had the unfortunate luck that a rapid heart rhythm occurs when a magnet of sufficient strength is over the device, then the device would not detect this rapid heart rhythm and it could be fatal. But the odds of that happening are very, very low. Remember, most of us don't attach refrigerator magnets to our chest. And the titanium can that makes up a pacemaker or defibrillator is not magnetic, so even if a person with a defibrillator tried to place a refrigerator magnet on their, it wouldn't stick. Carrying a refrigerator magnet in your hand is much farther than three centimeters from the device. So before you rush to replace all of your refrigerator magnets, take heart, you can still use them and will live to tell about it.

I think this study is interesting and warrants consideration for pacemaker and defibrillator patients, but a healthy dose of reality and awareness needs to temper the lethal hysteria generated by the investigator’s comments and the press’s eagerness to promulgate hysteria in the interest of improving readership.

-Wes

Sunday, December 03, 2006

Christmas Song Meme

Alright, Dr. A started it, and Dr. K tagged me tonight: pick your 5 favorite Christmas songs and get five other fellow-bloggers to do the same. As memes go, this one is easy and a great way to share the season with friends while reflecting on our youth and our own kid's excitement during the holiday season. My favorites:

5. "Grandma Just Got Run Over by a Reindeer" - kind of fits my sick sense of humor.

4. "It Came Upon a Midnight Clear"

3. "What Child is This?"

2. "Joy to the World."

And my alltime favorite, sung while the church lights are dimmed and the flame from a single candle is carried to everyone's else's candles at midnight on Christmas Eve:

1. "Silent Night"

And now, for my lucky five torch-bearers:

1. Moof (Payback's hell)

2. Dr. Couz

3. #1 Dinosaur

4. Rob at Musings of a Distractible Mind

5. Artemis

By the way, if you really want to surprise a checkout person while shopping in a crowded mall, just smile and say "Thanks. Merry Christmas!" They'll do a double-take.

Watch.

-Wes

Pfizer's Torcetrapib: Rest In Peace

What a blow. The Data Safety Monitoring Board evaluating torcetrapib, the HDL (or "good cholesterol")-raising drug, pulled the plug:
Citing patient safety, Pfizer said in a statement that it is terminating all clinical tests of torcetrapib and its plans to bring the drug to market. The company said it is asking doctors participating in studies of torcetrapib to tell patients to stop taking the drug immediately.
The reason was too many deaths in the torcetrapib plus Lipitor (atorvastatin calcium) arm of the trial, compared to Liptor alone.
The company said that 82 patients taking a combination of torcetrapib and Lipitor died, compared with only 51 deaths among those taking Lipitor alone. Pfizer said the study cast no doubt on the safety and effectiveness of Lipitor.
With such a large clinical trial, the excess deaths in the combination treatment arm of this trial could not go unnoticed.

As painful as it must have been, Pfizer did the right thing. They will feel the sting in their stock price over the short term, but in the long term, they saved many more lives with their bold decision and will survive to develop another blockbuster drug another day.

-Wes

Friday, December 01, 2006

Snow Day



"Dad, is it true it's a snow day?"

"Yep. They called us around 6 AM to tell us you don't have school today."

"Dude, we never get a snow day. I got two text messages telling me we had one this morning, but I didn't believe 'em."

Why is it I can never wake him up when it's a regular school day, but on a snow day, he bolts out of bed?

-Wes

UnitedHealth Shareholders Granted a Reprieve

From the Wall Street Journal this AM:
In an unusual move, a federal judge has temporarily barred ousted UnitedHealth Group Inc. Chief Executive William McGuire from exercising stock options or receiving any retirement pay or other exit benefits while an external, board-appointed committee establishes whether the health insurer has claims against him.

The order, which backs a joint motion by attorneys for several shareholder lawsuits and Dr. McGuire himself, puts on hold any agreement between UnitedHealth and its longtime chief executive over the terms of his departure until those legal questions have been answered. Dr. McGuire agreed to resign in October after an internal report concluded millions of stock options were likely backdated on his watch. He left the company yesterday with negotiations over his retirement package still unresolved.

The injunction is unusual in the annals of executive pay. U.S. District Judge James Rosenbaum of Minnesota handed it down late Wednesday partly at the request of attorneys representing a group of shareholder plaintiffs who have filed lawsuits against UnitedHealth. The complaints argue that the option backdating lined the pockets of Dr. McGuire and other top executives at the expense of the company. "If he were able to reap what we see as ill-begotten gains, we'd be asserting a claim without a remedy," said Karl Cambronne, lead attorney for the group.
No so fast, Dr. McGuire. Let's see what the external committee decides. It is also interesting to note:
Dr. McGuire also supported the plaintiffs' push for an injunction, and his attorneys even drafted the proposed court order, according to one person familiar with the situation said. The departing CEO believes the special litigation committee will vindicate him once "all the evidence is in," this individual said.
Let's see, according to one set of outside reviewers, some would put the odds of Dr. McGuire having timed all those option dates just right was about 200 million to 1? And we're not even talking about those other set of double-issued options, are we?

Good luck, Dr. McGuire.

You're gonna need it.

-Wes

Thursday, November 30, 2006

Code Blue

It had been a long day: a book chapter due, tons of consults, too little sleep, procedures. So when I had a minute to grab a little respite from the chaos while nature called, I took it. I sat on the throne to ponder the day. I needn’t go into gory details. But when I stood up, I heard a “plunck.”

“What the…?”

And I turned around and saw it. My pager. In the toilet.

Now one must make some serious decisions quickly in this situation.

Like, “do I get it or flush it?” Hmmm.

Oh, hell, I’m a doctor. So I grabbed it quickly.

Then rinsed it. And I washed and washed my hands, mind you. No Purell for me! Nope, I don’t trust that crummy residue it leaves on your hands. Lots and lots of soap and water. Then chlorhexidine just to be careful.

But then I realized I had not checked the patient.

“Pager, pager are you alright?”

No response.

“Quick, call 911!”

Thinking quickly, I removed the battery cover and extracted the battery. I shook it dry. Still no response.

Then I couldn’t remember – is it 15 button pushes to two hard breaths or 5 button pushes to 1 hard breath? Feeling that hypoxia and drowning were the most likely cause of sudden death, I chose the latter. Do I push the buttons half an inch or a quarter of an inch? Oh hell, I don't know. How old was she? I should have probably used epinephrine, atropine, or isoproterenol, but felt this might be one patient where a “quick code” might be in everyone’s best interest. After all, I had had her for about 6 years, and someone had her before me. It was time.

So I called the code. Time of death: 07:12 AM.

But as an electrophysiologist, I decided that water might have induced electronic hypothermia, so I gave one more thing a try...

... I slowly rewarmed the patient by placing her above an incandescent bulb while saying her last rights. "Rest easy," I said and borrowed another pager.

Later that night, I returned to the patient to check on her. I replaced the battery, inspected for a pulse and “viola',” tones chirped from her underbelly! A successful resuscitation at last!


Damn.

-Wes

Wednesday, November 29, 2006

The New Shareware?

Wow. Intel, Wal-Mart, and British Petroleum are joining hands (subscription required) in a "Kum Ba Ya" moment to try to develop an Electronic Medical Record (EMR) for their employees, housed on their own data warehouse creating the ultimate in shareware.

Hospitals, doctors, insurers, and the employers will have unfettered access to those records, but "they will belong to the employee." *Sigh*

But perhaps this data-sharing could be a good thing: fewer repeated tests, better continuity of care, a central repository of information where a consistent standard of information can be located. And yes, a wonderful place to see which doctors and hospitals are "performing" and which are not: who to pay, and who not to pay.

Employers are fed up with rising health costs and are rustling up their sleeves to do something about it. This, folks, is gonna happen.

The biggest issue now facing us: health care policy has to keep up with the advances in the EMRs being developed, or once your data is out there in the electronic ethos, it's out there for the millenium, just like, as the article says, "a Paris Hilton sex video."

-Wes

Tuesday, November 28, 2006

FDA and Pharma: Bed Partners?

After my Plaquequest post yesterday, I looked into the partnership arrangement between the FDA and BG Medicine a bit more today and found this statement from the FDA's own press release:
The agency ... concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development.
BG Medicine's press release was a bit more detailed:
25 Oct 2005: BG Medicine, a Massachusetts-based biotechnology research company, today announced the submission of a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's National Center for Toxicological Research (NCTR), to jointly conduct a liver toxicity study designed to overcome one of the primary obstacles to the efficient development of safe and effective drugs. The study, Liver Toxicology Biomarker Study (LTBS), aims to discover biomarkers of human hepatotoxicity in the standard test used by pharmaceutical manufacturers in the initial stages of drug development.

Liver toxicity is the most common biological reason for drug failure in the development of new pharmaceuticals, affecting one in six drugs in development. The toxicity tests currently in use by drug companies have been unchanged for at least 40 years and often fail to identify human liver toxicity issues. Consequently, liver toxicity is often detected for the first time when drugs are in phase 2 of clinical testing after tens of millions of dollars or more have been spent on a drug.

On March 16, 2004 the FDA released a report, "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," describing the "urgent need to modernize the medical product development process -- the Critical Path -- to make product development more predictable and less costly." The proposed project addresses the liver toxicity issue highlighted in the Critical Path document as one of the obvious and priority areas for innovation.

The CRADA process is a standard procedure for studies the FDA undertakes in collaboration with private companies. The liver toxicity study has been designed by BG Medicine and the FDA with input from a number of pharmaceutical companies. The study will be funded by and conducted in collaboration with pharmaceutical manufacturers. (Emphasis mine)

The research project leverages NCTR's and BGM's systems biology platforms for functional genomics, proteomics, metabolomics and computational analysis.

The LTBS will be conducted at the FDA's NCTR laboratory in Jefferson, Arkansas and at BG Medicine in Waltham, Massachusetts. The study is open to participation by all pharmaceutical manufacturers. Participating companies will receive a paid-up perpetual license to any biomarkers discovered and access to all project data.
Now I'm not sure what I think about this. The FDA is supposed to assure the safety of pharmaceuticals to the public. While the bureaucratic quagmire called the FDA certainly needs to streamline their approval of drugs, are they able to maintain their objectivity regarding drug evaluations when they've become "best buddies" with the pharmaceutical industry by using Big Pharma's funds and facilities like this?

I wonder.

Sure makes those pens and lunches from drug reps seem like chump change, doesn't it?

Anybody else want to weigh in on this?

-Wes

Played for Performance

Pay for Performance: To think our government, legislators, and insurance yahoos want to implement this for Medicare payments to physicians and hospitals. Look what it has come to in England.

Yuck.

-Wes

The Ice Palace

Where corporate insensitivity and death meet: the Ice Palace.

Well said. Thanks Dr. Sepkowitz.

-Wes

Monday, November 27, 2006

Plaquequest

Today the hunt for the vulnerable plaque will begin in earnest. It's not a new adventure, but one I like to think of a "Plaquequest."

"Vulnerable plaque" is the plaque within an artery that can suddenly "rupture" and stimulate the rapid formation of clot within a coronary artery, compromising blood flow to a portion of heart muscle, and leading to a heart attack. Cardiologists have long recognized that tightly narrowed arteries are not necessarily the ones that suddenly occlude during a heart attack; sometimes only modestly narrowed arteries become abruptly occluded. This has lead to a search for ways to identify which plaques are vulnerable to rupture before rupture occurs, potentially saving lives and heart muscle.

A consortium of researchers are assembling to attempt to identify vulnerable plaque. To the tune of $30 million. It is a huge undertaking, but the pot of gold at the end of the rainbow is just too tempting for industry to ignore. It is not surprizing that Merck and Astra Zeneca, two large pharmaceutical companies have joined the hunt. But BG Medical? Who are they? Described as a new "start-up company" in the New York Times, it's really a consortium of pharmaceutical and imaging industry interests including Astra Zeneca, Boehringer Ingelheim, Biorosettex, GlaxoSmithKline, Philips, Mitsubishi Pharma Corporation, the "Global Alliance for TB Drug Development" (what has tuberculosis got to do with this? I wonder if their membership is happy about this investment, but I digress) and...

..the FDA.

Really? The Food and Drug Administration is now a "Partner" with BG Medical? Maybe so. At least they're listed on BG Medical's "Innovative Paths to a Trusted Partner" page on their website. Certainly, there have been concerns regarding conflicts of interest with the FDA's "Special Government Employees" that advise the FDA having conflicts of interests with the pharmaceutical industry and what needs to be disclosed to the public. But to this doctor, the FDA itself has a responsibility to the public at large to maintain objectivity in its oversight of new drugs during the approval process. Certainly this partnership of the FDA itself with BG Medical violates the public's trust.

Oh, but we needn't stop here.

Look who else is "partnering" in Plaquequest: Humana, a manager of health care insurance plans.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope the profiles that emerge from the study will, in hindsight, show patterns pointing directly to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create new therapeutic products.
I'm not sure of their motivation here, but I wonder how much revenue and "best practices data" they receive for supplying the patients for this trial. Hmmm. It seems only Humana patients will be participating in this "research." Why?

Plaquequest is a noble goal indeed. Going after arteries already blocked is a $6 billion stent market. $20 billion more are spent for statin drugs for primary and secondary prevention of coronary disease presently. It seems clear that the drug and device industry wants to know if they can boldly grow this market so cardiologists can place stents in asymptomatic arteries cloaked under the "vulnerability" guise. Interesting, but will this work?

Lets say this research succeeds at Plaquequest. How do we apply this finding to John Q. Public? Do we then place a stent there knowing it could thrombose as a result of the stent being there? Or should we place everyone on a statin drug as we've already been recommended for anyone with significant hyperlipidemia. Doctors haven't historically been so good at even this simple recommendation. And imaging to screen for vulnerable plaque is expensive: who is going to pay for massive screening tests? (Take a guess) So what have we gained?

It's hard to know. Maybe some new drugs or insights to the mechanism of acute coronary syndromes will be discovered, leading to new research paths for these great companies. But I hope Plaquequest is more than a means for Humana to get more best practice and cost analysis data while doctors get to feel good that the pharmaceutical and medical imaging industry has "given back" to research centers, and maybe the FDA.

-Wes

Sunday, November 26, 2006

Infectious Disease: Bad Place for Malpractice Law

It's amazing how fast plantiff's lawyers will dump their clients seeking compensation for acquiring MRSA infections in Kentucky once real data regarding infection rates (and the difficulties with their interpretation) become available.

-Wes

Friday, November 24, 2006

James Bond: Saved by A Defibrillator


Tonight I learned that my field, cardiac electrophysiology, has finally reached prime time. If you haven’t had the chance, catch Casino Royale, one of the better James Bond flicks to hit the screen. Lots of action, a slightly more believable plot (can that happen?) and plenty of eye candy for all.

But best of all, I got to watch James (Daniel Craig) try to defibrillate himself! It happens after James Bond is poisoned by as tainted martini with “digoxin” at the poker table. He then develops blurred vision and moderate disorientation, and quickly excuses himself from the poker table. He then staggered to grab a shaker of salt and a glass, and proceeded to the bathroom, where he quickly induced vomiting. He then staggered to his Aston Martin Vanquish and opened the glove compartment…. and there it was: an automatic external defibrillator! Yep, smaller and more compact than commercially-available models, but a defibrillator nonetheless.

It turns out that a small chip implanted in James’ arm told his compatriots back at his headquarters that he was also suffering from “ventricular tachycardia.” He was then told to slap the defibrillator pads to his chest. They first elected to give him an antidote for the digoxin, but it was ineffective, so they proceeded to radio James and instructed him to defibrillate himself. James tries on multiple occasions to deliver the shock unsuccessfully, only to discover one of the connection pins to the defibrillator pads had become unplugged. He loses consciousness before he can replace the pin and collapses in the front seat of his car. Fortunately, his new-found love interest, Vesper Lynd (french actress Eva “OMG” Green), found James, plugged in the pin and proceed to cardiovert poor James back to life. As is true with Hollywood, he awakens unscathed and returns to the poker table, only to tell his arch rival Le Chiffre, “That last hand nearly killed me.”

Classic Bond. Great entertainment. Just a bit unreal, but then again, who wants reality when you can have "Bond,…

… James Bond."

-Wes

Device-based Hypertension Therapy?

All of us have had our blood pressure taken when we visit the doctor's office. Many of us have been told by a doctor that our blood pressure is too high and that we should "watch" it. Few of us, however, leave the doctor's office understanding how serious a health problem high blood pressure is or that it can lead to heart disease, stroke and kidney failure.

It is not that high blood pressure is especially difficult to control. Today's doctors can prescribe a wide range of good, affordable drugs that will lower your blood pressure and help you live a longer, healthier life. The problem is many of them simply don't. Some estimates have suggested that only 30-47% of patients with hypertension receive adequate therapy.

But occasionally, even with lots of medications and careful follow-up, there are a few patients in whom controlling blood pressure can be particularly difficult. For these patients there might be another option soon.

A new pacemaker-like device recently debuted at the American Heart Association meeting in Chicago this year to treat severe, drug–refractory hypertension. Made by CVRx, this device functions by stimulating the carotid bulb at the bifurcation (branch point) of the internal and external carotid arteries to activate the baroreceptor reflex.

The baroreceptor reflex is a normal reflex that the body uses to quickly provide more or less blood pressure to the brain with changes in posture. Elevation in blood pressures causes mechanical stretch of receptors (“baroreceptors”) in the carotid sinus. When stretched, these cells fire electrical impulses faster to stimulate centers in the brain that are responsible for deactivating sympathetic stimuli while activating the parasympathetic (or heart rate slowing and vasodilating portion of the body’s blood-pressure-regulating system to lower blood pressure. By stimulating these baroreceptors, researchers hope to use the body’s own baroreceptor reflex to drive blood pressure lower. The report of piloted patients appeared promising enough for the Food and Drug Administration to grant an Investigational Device Exemption (IDE) to expand the evaluation of the device to a larger cohort of patients.


Figure from the CVRx website


Early European results were reported for 12 patients at the European Society of Hypertension meeting in June 2006. In this study, after three months of active therapy, systolic blood pressure was reduced by an average of 24 mmHg (189 mmHg vs. 165 mmHg). In the preliminary US trial presented at the AHA meeting, three months of active therapy reduced systolic blood pressure by an average of 22 mmHg (180 mmHg vs. 158 mmHg) and diastolic blood pressure by an average of 18 mmHg (105 mmHg vs. 87 mmHg), using office cuff measurements. While data are preliminary at present, this device might become promising.

But there are some significant hurdles for the company to clear before the device can become reality.

First, because hypertension is painless and causes no symptoms until end-organ damage occurs, treating patients with an implantable device will be a hard sell for physicians. Furthermore, many patients with hypertension are simply left untreated by their physicians, or receive inadequate medical therapy. Confounding social and psychological problems, like alcoholism and medication non-compliance, further complicate therapy of hypertension. To think that such cases of hypertension warrant therapy with an implantable device is misguided.

Vanity, as well, will be difficult to overcome. From my experience with pacemakers, patients do not like their scar and associated discomfort occasionally experienced from pacemaker implantation beneath the collar bone (clavicle). Fortunately a shirt can usually cover the scar. But will patients want scars on both side of their neck with this device?

Safety issues also need to be addressed more completely. If the device is too effective in an individual patient and drop their blood pressure precipitously, how will it be inhibited? No sensor exists in the device to sense its effects on a persons’ blood pressure – certainly this is not a minor issue. Further, the baroreflex can cause profound slowing of the heart rate, or even asystole (no heart rate). No mechanism for pacing the heart (or a means of sensing the patient’s heart rate) exists in the device’s current design should a slow heart rhythm occur.

Finally, I hope that patients with renovascular hypertension are sufficiently screened before enrolling in a study using this device. Blocked arteries leading to the kidneys can result in profound medically-refractory blood pressure elevations and should be excluded before implanting this device.

In summary, the concept is interesting, but significant refinements are required before this device reaches the broader public. For now, treating hypertension early and often with conventional medical therapy and careful counselling is much more likely to be cost-effective at stemming hypertension’s end-organ complications.

-Wes

Thursday, November 23, 2006

The Quiet Before the Storm



Thanks to the readers of this blog and my fellow bloggers who have made this past year so much fun.

-Wes

Wednesday, November 22, 2006

From My Wife for Thanksgiving

From my wife, for whom I am infinitely thankful:

At the beginning of the holiday season, our extended family is about to sit at the Thanksgiving table. This time, at an assisted living facility, where other hands will be cooking the meal, in a room rented for the family to gather. As I look around the table tomorrow, my blessing will be realizing how rare it is that we are able to have so many loved ones in one place at one time – if just for an imperfect, fractious moment. Young, some home from college, some zooming through puberty. Old, some on the brink of hospice, some befuddled and tired, but still here. There will be sports jerseys and size 14 shoes, cheeks sprinkled with acne, gorgeous young girls with straightened hair, others bending over a wheelchair, and middle-agers. Many of us have traveled across several states to be here. What a rare moment, before the great wheel of life turns again.

We have met for years exactly like this (but in someone’s home), but this year I seem to understand the fleetingness of our time with each other. The young adults will move on, and so will the old. Some at the table have thus far led a blessed life – untouched by any misfortune. Others, including some of the young ones, have struggled with life-threatening illnesses and chronic disease, crippling depression and stunning failures. We join in all our imperfection, our silliness and preoccupation, our greatness and growing wisdom. If we are lucky, we sit at the Thanksgiving table able to give true thanks, albeit for a life that we barely understand. I hope you can too.

-Diane

Thanksgiving

As relatives arrive and meals are prepared for the traditional Thanksgiving observance here in the United States, it is useful to reflect back to the original observance credited to a gathering of Pilgrims and the Wampanoag Native Americans. Theirs was a celebration of post-harvest fortunes in 1621. The celebration occurred because of an unusually abundant harvest that year. Other years had not been so fortunate, since the number of Native Americans exceeded the number of surviving English at that point – a point often forgotten in the remembrance of this day.

Life was difficult then. Disease was common. Life expectancy to a child born in 1621, was a mere 35 years: nowhere near what we enjoy now. And while each of us should reflect and give thanks for our friends, family, and material goods we have today, perhaps the greatest gift that we can give thanks for is our longevity and the additional time we have to live our lives together.

It is remarkable to remember that penicillin wasn’t discovered by Alexander Fleming until 1928 and has ushered in the remarkable antibiotic era we enjoy today. That is only 78 years ago: about one man’s lifetime today. But in 1928, penicillin was cleared so quickly by the kidneys that it was often recaptured and purified from a patient’s urine due to short supply of the drug. Gratefully, probenecid was later developed to slow penicillin’s excretion in the kidneys. And more developments soon followed. Development after rapid development. The number of antibiotics available today is staggering.

Eric Zorn, a syndicated columnist from the Chicago Tribune today, put it this way:
At my age 600 years ago, even if I were Eric I of England, I’d likely be reposing in a splendid crypt. As it is, I’m perfectly healthy and taking the kids to see their grandmother in Pittsburgh, entertaining them in the mini-van with a tiny electronic slab that holds 1,500 songs, eight podcasts and two unabridged books on tape.
Yes, he’s solidly, and remarkably, in “mid-life” with plenty of years still ahead.

So as you sit down for a holiday meal, stop, think, reflect, and give thanks…

… for life.

-Wes