Are Smokers Slackers?

At least one study thinks so.

The research team analysed nationally representative registry data on sickness absence among more than 14,000 workers in Sweden between 1988 and 1991.

Of the sample included in the study, 45 percent had never smoked.

Of the remainder, 29 percent were current smokers and 26 percent former smokers.

Non-smokers took the fewest days off sick; smokers took the most.

Across the whole sample, the average number of days taken as sick leave was 25.

But smokers took almost 11 extra days off sick compared with their non-smoking colleagues, equal to 43 percent of all sick leave taken every year among the sample, say the authors.

There was little difference in the number of additional days taken as sick leave between male and female workers.

-Wes

Source reference from British Medical Journal's Tobacco Control.

Implications of Zelnorm's Withdrawl

Zelnorm (tegaserod maleate), a serotonin 5-HT4 receptor partial agonist indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation, was pulled today from the market by Novartis on the recommendation of the FDA. It had previously been reported to have rare instances of ischemic bowel associated with the drug's use and now appears to have rare, but significant, problems with ischemic cardiovascular disease after a retrospective review of 29 studies of the drug.

(CBS News) Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

This drug follows closely the pulling of Pergolide yesterday two months after reports in the New England Journal of Medicine demonstrated the problems with this drug causing valvular regurgitation (leakage). It seems we'll be seeing more and more drugs pulled after the Vioxx fiasco and closer scruitiny by the media and Congress. But the incidence of problems (0.012%) vs (0.0014%) is mighty small, especially when one considers that acetominophen (Tylenol®) liver toxicity approaches a 4% incidence in emergency rooms in the US and England. Will Tylenol® be next?

These withdrawls suggest that even retrospective meta-analyses of outcomes that demonstrate almost no side effects will be the expected norm for drug safety in the post-market drug survellance era we have entered. Certainly, the potential for litigation is significant if side effects and potential complications are not disclosed. However, while patient safety is always paramount, the risk/benefit ratio of any drug should be considered when it is prescribed and there may be circumstances when certain drugs with higher side effects are in the patient's best interest.

So now I'm confused. How do we compare the incidence rate of side effects of drugs we prescribe? Are some drugs held to a double standard? What drug safety level should doctors tolerate?

-Wes

via KevinMD.

UNICEF's Virtual Smokescreen

This week’s Lancet had a short spot of Teen Second Life – virtual on-line world restricted to 13-17 year olds that allows them to “build” a virtual environment and interact with other teens on-line.

I don’t like these games because I think their motivation for existence is not altruistic, but financial.

You see, these games are all structured about the same way. They all hook kids by telling them they can join and get a “basic” membership to the on-line world for free. Later, as they get hooked on the game, then only allow them to go further in the game by purchasing a “premium” membership. And to be successful socially in these worlds, the coolest kids own stuff that must be purchased.

And here’s my beef. Teens know that their parents don’t like them to be sitting at a computer all day. So in order to be successful at these on-line virtual worlds with their on-line peers, most kids have to stretch a very important line with their parents: they must use their parent’s credit card to purchase the “premium” package to gain access to new "powers" or (in the case of Teen Send Life) "land" – often without their knowledge. You see, when you can’t see the cash, it’s virtual, too.

I know this from personal experience. Kids are savvy and know how easy it is to enter the data on the front and back of a credit card to purchase whatever they want on-line. They know it’s not permitted to use their parent’s credit card, but their virtual world can become more important to them than their real-world relationship with their parents. And once the charge is made once, it shows up month after month on the parent’s credit card as a recurrent charge. Breaking this addiction can be difficult, to say the least.

So to find out that UNICEF is using Teen Second Life to promote their ’World Fit for Children’ festival as part of their ‘Global Kids Digital Media Initiative,’ raised concerns, to say the least:

In December, 2006, Global Kids, a non-profit organisation (sic) based in New York, teamed up with the United Nations Children's Fund (UNICEF) to put together a World Fit for Children Festival in Teen Second Life's virtual world. The teenage participants attended workshops about UNICEF and then constructed virtual buildings that could, in theory at least, help alleviate poverty, poor education, or HIV/AIDS. The winning team of teenagers from Finland was awarded $200 for their building—an African school where children could learn safely. UNICEF believes that more than 1000 teenagers visited their virtual festival.

But there were interesting findings, like kids that can fly, or have a playboy logo as their “flag,” (see their video) or smoke behind a virtual bike sheds. If this the way we want to promote real-life solutions for real life-and-death issues like HIV and AIDS? What does the message does the Playboy flag send in this regard – that AIDS is just a big joke?

I take real issue with the Lancet author James Butcher’s assessment of the virtual world to teach real-world values:

Parents will have concerns about this virtual world, but the benefits in terms of creativity and socialisation (sic) surely outweigh the risks. The only real concern should be whether parents can keep up with teens reared in our digital world.

No Mr. Butcher, we can keep up. It’s the fraud engendered by these sites and the mixed messages they portray that has me concerned, especially when Global Kids and UNICEF uses these venues to promote their agenda.

-Wes

References: James Butcher, "Smoking Behind Virtual Bike Sheds," The Lancet, Volume 369, Issue 9567 , 31 March 2007-6 April 2007, Page 1074.

Global Kids/Unicef Festival Promotional Video on YouTube

Global Kids Digital Media Initiative Website.

Stem Cell Therapies for Weakened Hearts

Now that the American College of Cardiology meeting has come to a close, a number of interesting reports have surfaced that promise to attack the weakened heart using stem cells. Even stem cells on stents are being evaluated.

While the results are exciting, careful evaluation of the very preliminary data is warranted. For instance, echo measurements demonstrating improvements of "1 mm" more of systolic contraction in 23 patients can hardly be classified as significant, since the resolution of reproducible measurement exceeds this amount. Also, the data suggest a trend (though again, not significant), of other possible issues with immune disorders or infections. Nonetheless, what was encouraging was that the authors found that their data did not demonstrate a worstened outcome in any patient so far.

Perhaps the best review of the current state of the art in this area has appeared recently in the New England Journal of Medicine. This report sheds light on the difficulties demonstrating long-term improvement in patients to date. Additionally, delivery of cells to their target has also been complicated:

Some of the complications of delivering cells or drugs locally to the heart are the inherent motion of the organ, the compatibility of the device with the treatment being injected, and the distribution of the therapy within the tissue. Other potential routes of cardiac delivery include intracoronary injection, adventitial delivery, epicardial injection, and pericardial injection.

The development of methods for delivering stem cell therapies to the heart is not straightforward. There are many complications and contradictions. Animal studies show that the success of a delivery method is different for a healthy heart than it is for a diseased heart.

There may be an additional mechanism where cells can find their way into the heart, which is not available for a normal heart, said Dr. Palasis. Many delivery devices in development for cardiac cell therapy are actually angioplasty catheters, and these devices come with their own complications.

If angioplasty catheters are going to be used for cell therapies, its important to look at potential for catheter materials to affect viability of cells. Guidewire lumens could be covered with lubricants. The FDA is aware of the compatibility issues. Both acute cell delivery and cell engraftment depend on the delivery method used.

And while early results of the more recent works may suggest a benefit to these therapies, they certainly have a long way to go before they can be applied to the populace at large. Perhaps the best advise came from the NEJM article:

Recent randomized studies of cell therapy for heart disease represent a milestone in this rapidly developing field while serving as a cogent reminder that many important clinical and fundamental questions have yet to be addressed. We should guard against both premature declarations of victory and premature abandonment of a promising therapeutic strategy. The ultimate success of this strategy is likely to depend on continued and effective coordination of rigorous basic and clinical investigations.

-Wes

The College Visitation Game

Well, we made it out to Boston, MA today to look at colleges. Got here early, dropped off our bags at our hotel, and took the “T” (Boston’s subway) to Cambridge, and visited "Haaavaaad." Tomorrow Boston University and then Boston College. Maybe Tufts. Maybe not. Parents are just along for the ride, after all.

Beautiful campus in a fun city, Harvard is a ridiculously competitive school in which to gain entry (duh!), and costs a mere $46K a year. But they were proud to say they are “need-blind” during the admissions process. In other words, don’t worry about how much it costs, just get perfect scores, perfect grades, and perform effortlessly with 50,000 extracurricular activities, and we’ll consider you for one of our 2050 spots each year – of some 23,000 applicants.

But if you earn over $80,000-$100,000 per year, well, suddenly Harvard seems to have 20/20 vision. They see the doctors and the doctors’ kids coming: after all, they can PAY! But, hey, they said, “everything’s included.”

I think they meant tuition, room, and board. Spending money and travel costs to and from home – well, those you get to pick up, too. * Sigh * Now don’t get me wrong in case a few Harvard grads out there are foaming at the mouth – I really have nothing against Harvard, per se, but rather this Spring Break Right of Passage that all of us “good parents” must endure on behalf of our children who want to attend any competitive school.

My son sat through the orientation process and realized they did not cover information on his area of interest: performance music. (Yes, I know, he feels he must avoid medicine like the plague – but then again he REALLY loves classical music and is passionate about it, so what can I do? Ah, but I digress – back to the college visit gig…) He later stopped and asked about their program, and found out there were just 4 student positions here at Harvard for students in this field here. He seems to feel he'd like a new more kids with a similar interest in music, and he also realized that his grades, well, he thinks they might not be competitive after all... But it WAS fun to visit…

After attending these orientation dog and pony shows at several schools this week (and also previously with my older son) I have learned that they’re all pretty much the same. Here’s what they say: “We have a great student body, very diverse, of course, and all are well-rounded student scholars with zillions of interests – all are in the top 10% of high school students, all have average ACT scores of 31-35, all have an average GPA of 4.0, and our school gets about 22,000-28,000 applicants for about 500-4000 spots (depending on the size of the school).” I think the "Common Ap" (the one common electronic application that kids can forward to tons of schools at once) makes it possible for all of these schools to share the same statistics...

Zzzzzzzzzzz. Worthless cr*p, really. I mean, why does EVERY school insist that they are the only ones getting the top 10% of high school students? I’m looking for the one school that says: “yes, folks, we actually accepted someone with a 3.2 grade point average!” Now THAT would be something NEW and INTERESTING!

Anyway, here are my thoughts about this college visitation rat race: if I were to do it all over again, I would likely apply first, then visit campuses.

First of all, my son and I would pick a big, medium and small school that interested him and visit just those to get a feel for what a school of each size is like. We might also pick one public and one private school in the bunch, just to see the difference. And that’s it. Then apply. After acceptance, we'd use the college trip to decide where to go – the city, the size, the people, living arrangements, etc. will be much more pertinent to your child than listening to all of the hype during the pre-application campus visits.

Harkening back to my college admission days, I don’t remember it being like this. In fact I’m sure that with the caliber of kids today and the requirements to gain admission to top undergraduate and graduate colleges today, I’m not sure I would have made the cut. It’s mighty tough out there.

But what I did see today (and several of the preceding days), was the wonderful idealism of so many young minds eager to enter medicine or another health care field: each of them wide-eyed and bushy-tailed and eager to make the commitment to learn their art. Despite all of the changes in our field today, medicine is still held in high esteem by incoming students.

And suddenly I realized that each of them was striving to take my place someday.

And you know what? It instilled in me a sense of calm that it will all be OK when they do. After all, with that kind of boundless enthusiasm and brains, I would look forward to being their patient.

-Wes

More Marketing Idiocy

Big Pharma woos cardiologists. First pens and lunches, now w/arcade rides.

Sheesh.

-Wes

Ranolazine: An Antiarrhythmic?

In an earlier post, I expressed my concerns over the potential safety of a new anti-anginal drug made by CV Therapeutics, ranolazine (trade name, "Ranexa®"), due to its propensity to prolong QT interval, especially in patients with hepatic dysfunction. The post generated contentious debate over my assessment, to say the least.

To address safety concerns also raised by the FDA and in an attempt to broaden the indications for ranolazine, CV Therapeutics performed a study to test the efficacy of ranolazine in patients with acute coronary syndrome to reduce cardiovascular death or recurrent ischemia. The study was titled the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes: TIMI-36) trial, and its initial results were released before the ACC meeting on 7 February 2007 because it failed to meet its primary endpoint:

MERLIN: Main efficacy results

End point	Placebo (n=3281)	Ranolazine (n=3279)	HR	p
CV death/recurrent ischemia*	23.5	21.8	0.92	0.11
CV death/MI	10.5	10.4	0.99	0.87
Recurrent ischemia	16.1	13.9	0.87	0.030

*primary end point
Safety results showed no difference between the two groups in death from any cause or sudden cardiovascular death. In addition, there was a reduction in clinically significant arrhythmia on Holter monitoring.

What was not known (until today) was the results of the safety data with this trial, especially as it relates to the potential for proarrhythmia:

MERLIN: Main safety results

End point	Placebo (n=3273)	Ranolazine (n=3268)	HR	p
Death—any cause (number of patients)	175	172	0.99	0.91
Sudden cardiac death (number of patients)	65	56	0.87	0.43
Symptomatic documented arrhythmia (number of patients)	102	99	0.97	0.84
Clinically significant arrhythmia on Holter* (% of patients)	83.1	73.1	0.89	<0.001

*ventricular tachycardia greater than 3 beats, supraventricular tachycardia >120 bpm, new atrial fibrillation, brady less than 45 bpm, complete heart block or pause greater than 2.5 s

The reduction in arrhythmic events was surprising and warrants further evaluation - how many of these were supraventricular versus ventricular arrhythmias? Could ranolazine act in a similar mechanism to amiodarone (another effective anti-arrhythmic that prolongs QT interval) as an anti-arrhythmic medication? The data, as presented, are incomplete but offer an unexpected finding that should provide a niche for this drug in the use of patients with chronic stable refractory angina. While the company's special protocol assessment agreement with the U.S. Food and Drug Administration (FDA) could support expansion of the existing Ranexa® (ranolazine extended-release tablets) indication to include first line angina, the MERLIN trial did not address the use of this drug in heart failure patients. As such caution should be exercised applying these findings more generally to patients with the potential for hepatic dysfunction from any cause, including congestive heart failure.

-Wes

Ever Wonder What Your Doctor Hears in Your Heart?

Now you can listen.

-Wes

From Dr R S MacWalter, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland.

14-Year Olds Take on Big Pharma

I always knew that kids today are getting smarter and smarter, especially in science, but this takes the cake:

(WSJ) Global pharmaceuticals company GlaxoSmithKline PLC faces a court case Tuesday on charges of misleading advertising after two 14-year-olds from New Zealand found its popular black-currant drink Ribena contained almost no vitamin C. High-school students Anna Devathasan and Jenny Suo tested the drink against advertising claims that "the black currants in Ribena have four times the vitamin C of oranges" in 2004. Instead, the two found the syrup-based drink contained almost no trace of vitamin C.

I guess these chemists won't be looking for a job with Glaxo, will they?...

-Wes

No Stent? It'll Take COURAGE.

“Ms. Jones, you know that chest discomfort you get after you pick up your mail and walk up the driveway back to your home?”

“Yes?”

“Well I’ve got good new and bad news.”

“What’s that?”

“First the bad news: your angiogram demonstrated you’ve got 80% blockages in two of your three arteries on your angiogram today.”

“What’s the good news?”

“Well, according to this important trial today I heard about at the American College of Cardiology Meeting, we’ve just got to put you on five medications, and ask you to take it easy for a while, and you’re likely to do fine.”

“But what about those 80% blockages, doctor? Isn’t that pretty close to 100%? And if it gets to 100%, what happens?”

“Well, I suppose you could have a heart attack. But this study I read about today suggested the same thing might happen if you get a stent, too.”

“But doctor, aren’t you going to DO ANYTHING about my blockages?”

“Yes, Ms. Jones, I’m going to put you on all of these pills – they’re good for your heart.”

“But I don’t like taking pills, doc. Isn’t there anything you can do?”

“This is what I’d recommend right now, Ms. Jones.”

“But all of my friends have gotten a stent, and they seem pretty happy.”

“ I understand, Ms. Jones, but our thinking about this is changing rapidly…”

“What would you have done yesterday?”

“Honestly?”

“Yes doctor, honestly.”

“Probably given you the stents.”

“I think I’ll get a second opinion.”

“I understand, Ms. Jones. Don’t forget to get those prescriptions I wrote for you.”


* * *


Potential implications from today’s COURAGE trial?

• Potential lost interventional cardiology revenue, but many more visits for non-invasive cardiologists to assess adequacy of medical therapy and more stress test/nuclear imaging tests over time.


• Increased drug company revenues, especially manufacturers of statin drugs.


• Possibly lower investment in 64-slice CT scans knowing that medication therapy is the preferred first-line of therapy in patients with asymptomatic coronary disease.

But what should be remembered before the doomsday predictions for the stent makers take hold, doctors will have a difficult time always recommending stents for the above reasons – especially when 35,539 patients who were assessed for eligibility in the trial, 32,468 were excluded for a variety of reasons. Remember, patients with severe ventricular dysfunction, clinical instability, or very early ST-segment depression or hypotension on stress testing were excluded from the trial. Certainly in a carefully selected patient population, these results are important, but there are still plenty of patients out there hwo will continue to need the services of an interventional cardiologist.

Will bypass be similarly affected by reduced referrals? Very likely.

What is certain: a seismic tremor was felt in the cardiology community today…

-Wes

References: New England Journal of Medicine COURAGE Trial

NEJM Accompanying Editorial

Decisions, Decisions

There are many times as a physician that we must decide on activities that supercede our professional responsibilities. I recently had to make such a decision, albeit minor: should I attend the American College of Cardiology (ACC) meeting in New Orleans, LA or take the time to travel to visit colleges with my son?

Needless to say, this decision was relatively easy.

Unfortunately, it leaves me a bit stale on the front of the latest and greatest in news coming from the ACC Annual Scientific Sessions in New Orleans. I elected to stay behind on call last weekend, since I am traveling today. But I am encouraged that I can keep up with some of the major late-breaking clinical trials on-line since many of them will be simultaneously published as they are presented. At least this way it gives us non-attenders a chance to peruse the data more carefully and formulate our own conclusions and insights. While there are some who have argued this "fast-track" of review might not subject studies to adequate scruitiny for publication, I still appreciate the opportunity to review the data presented at my own, less frenetic pace on-line. With the dissemination of information in this way, the larger populace of the internet-surfers can now chime in on the studies by way of blogs and commentary, such as the recently-added interactive "Journal Club to Go" on the webpage of the Journal of the American College of Cardiology's website.

So bear with me as I shuttle from place to place this week - today I'm in Ann Arbor, MI. After all, there are important decisions being made...

-Wes

The Malignancy of Heart Failure

With the release of the results of the EVEREST trial at the American College of Cardiology Meeting in New Orleans and simultaneous publication in the Journal of the American Medical Association, a surprising revelation occurred to cardiologists who treat heart failure: fluid loss means little to overall survival.

For those unfamiliar with the EVEREST trial, it tested the effectiveness of a vasopressin inhibitor, tolvaptan, at reducing fluid retention in heart failure as a means to improve cardiovascular mortality. Vasopressin’s (also called “anti-diuretic hormone”) action in the kidney is to retain free water in the distal collecting tubules of the nephron in the kidney. It is alcohol’s inhibition of vasopressin that causes a brisk diuresis that contributes to the post-drinking hang-over and dehydration. Ah, enough about my college days…

Anyway, the drug tolvaptan also inhibits vasopressin, and permits excretion of increased free water (as evidenced by the sustained volume loss and elevation of serum salt (sodium) levels in this study). Unfortunately, these beneficial effects had no effect on all-cause or cardiovascular mortality after two years of follow-up in the trial.

What struck me was the high incidence of cardiovascular mortality in this heart failure patient population (NYHA Class III and IV): an incidence of about 20% - even in spite of aggressive therapy with beta blockers (70.2% of patients), angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors (84.2%), and diuretics (96.8%).

It seems we have a long way to go to improve mortality in this population.

Which then begs the question: in light of the improvements in mortality in severe heart failure documented in the MIRACLE, COMPANION, CARE-HF and SCD-HeFT trials, why is there no mention of device-based heart failure therapies in this trial? Were these devices implanted in these patients? If so, in whom?

Perhaps if these device therapies were deployed earlier in the course of treatment in this severe heart failure population, we could better impact this abysmal mortality rate.

-Wes

Stent Shrinkage

I heard a new term related to coronary stents today: "shrinkage." Unlike the manly "shrinkage" of the Seinfeld show, it seems new polymer stents can also suffer from "shrinkage:"

(TheHeart.org) Dr Patrick Serruys (Thoraxcenter, Rotterdam, the Netherlands) presented results of the ABSORB trial during a late-breaking session at the American College of Cardiology 2007 Scientific Sessions today. In the trial, 26 patients received the new stent—which, it is hoped, will completely dissolve after 12 to 18 months—and there was no evidence of stent thrombosis after six months, together with a low rate (3.3%) of ischemia-driven major adverse cardiac events (MACE).

But late loss and restenosis were greater with the bioabsorbable stent than with current drug-eluting stents, and Serruys said the 15% shrinkage seen with the new stent may be to blame for these findings. He is hoping that the modification of the stent design—due to be completed by the end of the summer—will solve this problem. "This may be the beginning of a new era. I'm convinced of it," he commented.

However, chair of the late-breaking press conference, Dr Spencer King (Emory University School of Medicine, Atlanta, GA), was more circumspect: "Our early experience with polymer stents was terrible in experiments in pigs. This trial is in only 30 patients, with short follow-up. However, on the plus side, we didn't see any inflammation. Time will tell."

My guess? Shrinkage has already killed this current generation of bioabsorbable stent, but a second-generation polymer stent is already in the works...

-Wes

Traveling Salesmen

With the advent of the Electronic Medical Record, physicians have become the traveling salesmen for hospital systems.

In earlier days, it mattered that you were near your records, so you could consult them to review critical information from earlier treatments and review response to therapies of your patient. Now, with the advent of the Electronic Medical Record, it matters little where a physician is located – he can instantaneously review his patient’s medical record, xrays, EKG’s and a host of other tests anywhere there is internet access. Bills are submitted for reimbursement before patients leave the operating room. Information moves at the speed of light.

Hospital systems, in the era of declining reimbursement per patient visit, realize that growth requires expansion: increase the numbers of patients seen in your system to offset the decline in reimbursement. Initially hospitals responded by increasing office hours to the more convenient nights and weekends – marketing their efforts as “responding to the patient’s needs.” Certainly, this effort was welcomed by many of the busy patient professionals with insurance. It was a win-win for many patients and hospitals alike. Doctors, too, could see the increased revenue by working more “patient centric” hours – but at a price to their own family lives.

Now that virtually every daylight hour is covered by clinics feeding hospital systems, a new tactic emerges to continue growth – expand geographically. For now, doctors can work at multiple geographically separate facilities and have access to all of the information they need. In fact, many are encouraged to open new clinics farther and farther from the Mother Ship in an effort to reach the health care system’s tentacles into ever-expanding regions. The consequence? Doctors cannot be in two places at once.

When a patient at Location A has a problem after a procedure or treatment and the treating doctor is at Location B, the treating doctor must rely on a colleague to manage the issue until he can return. Doctors, then, become interchangeable to the patient. And while the professional aspects of what we do remain important (as do our professional identities), the sad reality is that we are becoming interchangeable commodities in the health care system.

-Wes

Procedural Darwinism

New procedures in medicine do not always stay – they must survive.

I have been interested to see Procedural Darwinism at work in my daily practice. Charles Darwin introduced his theory of natural selection of species to the scientific community at the turn of the 20th century. But his work, I have found, is not limited to all creatures great and small – it is related to medical procedures as well. You see, some procedures that heath care professionals perform provide good value to the medical community and the doctors themselves, while other procedures are too time-consuming and too economically under-reimbursed to survive in the ever-frenetic pace of medicine today.

Take the stethoscope, for instance. It is rapidly succumbing to Procedural Darwinism. If it weren’t for the stethoscopes ability to hear breath sounds, it would have been extinct long ago. The echocardiogram is far superior to “hear” heart sounds, and adds procedural survival protection by providing additional size, structure, and functional information regarding the heart with little pain or toxicity to the patient. The echo also reimburses well. The echo will clearly and directly survive Procedural Darwinism.

Although it may be on the “Endangered Procedures” list because it reimburses nothing to the physician, the stethoscope still clings to Procedural Life by providing important value to the physician in a different venue: there is no faster way to detect the early onset of congestive heart failure or pneumonia. Stethoscopes survive, then, by providing indirect economic value to the physician (by making him improve outcomes and therefore referrals). Therefore, by indirect economics, the stethoscope is likely to survive Procedural Darwinism.

But some new procedures may not survive Procedural Darwinism. One such procedure is T-wave alternans testing for the evaluation of patient considered to be at risk for sudden death. For those not familiar with this test – it is like a treadmill test, but much more time-consuming to perform. It uses special (and relatively expensive) electrodes configured in a non-familiar way (to people who do these test for a living), and detects information that cannot be seen by the naked eye (therefore it’s hard to believe/understand/verify by those who do treadmills for a living). It also requires remarkable fortitude to assure reliable data are collected (have to hold the heart rate in a narrow range for a pre-specified amount of time). Worse still, the economics of reimbursement are poor: the “special” electrodes cost $74 a set while the entire inpatient reimbursement is under $150 for a test that takes at least 45-60 minutes per patient to perform in the inpatient setting. While the costs in the outpatient setting are a bit more favorable ($300 reimbursement), there are Medicare coding rules that are complicated to perfect, and therefore – at least in Illinois - difficult to assure collection of any reimbursement in the first place. This procedure, as it stands now, is destined for Procedural Extinction unless something changes.

St. Jude’s recent resuscitation of Cambridge Heart (the maker of the only approved T-wave alternans machine to date) flies against the forces of Procedural Darwinism. St Jude feels they have an answer to counteract their declining defibrillator sales: that the indirect value of T-wave alternans testing in terms of increased referrals for defibrillator implants will justify the hours spent performing the test (and revenues/time lost). If internists are to perform the test, unless they receive a kickback for such a referral to cardiac electrophysiologists, there will be little economic reason to perform this test due to its difficult procedural requirements in terms of time and reimbursement.

T-wave alternans testing will only survive if environmental conditions change: that is, a mandate by Medicare to require the testing for people with weak heart muscles and no prior arrhythmia or heart failure. Even then, the application of this test, when other better reimbursing tests exist (like EP testing), keeps this test likely for extinction.

-Wes

On Cheney's Painful Leg

Vice President Dick Cheney required a reevaluation of his leg because it was sore yesterday:

After consulting with his doctors, Cheney was asked to return to George Washington University Hospital for repeat ultrasound imaging of the clot in that leg, said spokeswoman Megan McGinn.

"The ultrasound revealed no extension or complication of the clot," she said. "His blood-thinning medication was found to be therapeutic. These results are expected and reassuring."

Pain after the acute development of a DVT is usually caused by thrombophlebitis - an inflammation of the veins. This is usually improved after treatment with anticoagulants and analgesics. The time-course of Mr. Cheney's current discomfort might herald something more insidious and problematic: post-phlebitic syndrome.

Post phlebitic syndrome is thought to be cause by disruption of the venous valves from a pre-existing blood clot. These venous valves help shuttle blood back toward the heart. When the venous valves are damaged (as from the development of a clot), elevations in pressure within the venous system of the leg causing venous hypertension (from eMedicine.com):

Two major mechanisms in the body prevent venous hypertension. First, bicuspid valves in the veins prevent backflow and venous pooling. DVTs commonly occur at these valves, causing irreversible damage to the valve. Second, during normal ambulation, calf muscles decrease venous pressures by approximately 70% in the lower extremities. With rest, pressures return to normal in approximately 30 seconds. In diseased veins, ambulation decreases venous pressures by only 20%. When ambulation is stopped, pressure in the vein lumen increases slowly, returning to normal over a period of minutes.

Venous hypertension in diseased veins is thought to cause CVI (chronic venous insufficiency) by the following sequence of events. Increased venous pressure transcends the venules to the capillaries, impeding flow. Low-flow states within the capillaries cause leukocyte trapping. Trapped leukocytes release proteolytic enzymes and oxygen free radicals, which damage capillary basement membranes. Plasma proteins, such as fibrinogen, leak into the surrounding tissues, forming a fibrin cuff. Interstitial fibrin and resultant edema decrease oxygen delivery to the tissues, resulting in local hypoxia. Inflammation and tissue loss result.

Looks like Dick might need to lay low a while and wear those compression stockings. Otherwise, he could risk the serious complications of venous disease like a venous stasis ulcer.

-Wes

Telephone Triage

He had been becoming increasingly short of breath over the past three days. He could now only sit upright, leaning forward. Words came quickly.

“Honey!”

“Yes, dear?”

“Call…*gasp* the…*gasp* doctor…”

‘Yes, dear. Right away.”

Let’s see … 1 - 8 - 4 - 7 ..."

“Hello, you have reached the office of Drs. X, Y, and Z… We apologize we cannot come to the phone right now, but all of our secretaries or receptionists are busy helping another customer. If you feel this is a real emergency, hang-up and dial 911…”

No emergency now, she thought, he just needs to talk to his doctor.

"If you’re calling between the hours of 12:00 and 1:00, our office will be closed for lunch…"

“Honey? *gasp*”

“Yes, dear?”

“Any *gasp* answer?”

“Not yet, dear…”

... "If you’d like to get the location to our offices, press '1', if you’d like to make an appointment, press '2'…"

“Honey! *gasp*”

“Yes, dear?”

“What’s *gasp* goin’ *gasp* on?”

"Just a minute, Harry!"

"...If you’d like to call regarding a prescription or prescription refill, press '5', if you’d like to inquire about our new office hours in Eastville, press '6', in Westville, press '7'…"

*Gurgle* *Gurgle* *Cough* *Wheeze*

“… or, if you’d like to leave a message, we’ll call you back later… or, if, you’d like, press “0” to speak with our receptionist. Press '*' to hear this selection again…"

A loud thud is heard in the background.

“Which office does Dr. Y usually see you, Harry?...”

. . .

“Harry? Harry?”

Hospitals Building for the Woo-Factor

Welcome to the Hotel California
Such a lovely place (Such a lovely place)
Such a lovely face
Plenty of room at the Hotel California
Any time of year (Any time of year)
You can find it here.

“Hotel California”, The Eagles

This morning, Laura Landro of the Wall Street Journal mentioned that hospitals are creating a “healing environment” through huge construction costs that is cloaked in an effort to improve outcomes based on “evidence-based design:”

Amid a $200 billion construction boom to replace or rebuild aging and outdated hospitals over the next decade, health-care architects and designers are creating a new blueprint for a "healing environment," based on a growing body of evidence showing that the quality of a hospital's patient rooms, corridors and public spaces directly influences both the health outcomes of patients and the stress levels and efficiency of hospital staff. In addition to private patient rooms and "social spaces" for family members, new designs include decentralized nursing stations to reduce staff chatter, acoustical tiles and carpet to reduce equipment noise, special filtration systems to improve air quality and neutralize odors, and access to gardens and natural light to reduce stress and combat depression that can be exacerbated by noisy, chaotic and harshly lit hospitals.

Just as doctors practice medicine based on evidence of effective treatments, hospitals are turning to "evidence-based design," as studies show "the built environment has an important impact on outcomes in health care," says Debra Levin, president of the nonprofit Center for Health Design, a leading research group that is working with about 40 hospitals on a program known as the Pebble Project to document examples of health-care facilities whose design has made a difference in the quality of care and improved financial performance.

While there are certainly benefits to private rooms in hospitals by reducing the spread of “super-bugs” in hospitals between patients, we really can’t forget the real reason hospitals are spending money now – the woo-factor.

For it is the woo, not “evidence-based” design, with its attractive architecture, pleasant lighting, etc., that patients demand – and hospitals, after all, are entering a period of unprecedented competition between centers to attract well-to-do patients with money (and insurance). In this era of declining revenue, and increasingly savvy patients who can check out “hospital quality” on-line - it’s build or die.

-Wes

Colonic Beauty

My GI colleagues are excited.

As if to harken back to the 18th century uses of smell and decorum, Procter & Gamble is launching a new ad campaign modeled after cosmetic lines for the fiber laxative Metamucil to give you "drop-dead gorgeous guts" called “Beautify Your Insides.”

"Primp, Coif, Gussy Up... your insides with Metamucil!" the ad goes. "It's 100% psyllium-infused." (Minor correction: it's just 100% psyllium - the only infusing here is advertizing manipulation, but I digress).

Procter & Gamble feels this feat of fancy flourishing of flatulence and feces will find favor with the females.

But the ad campaign confuses colonic beautification with the beneficial cholesterol-lowering effects of psyllium on the heart.

In the Lipid Assessment Treatment Project which reviewed the effectiveness of all strategies of lipid-lowering in the general population, only 38% achieved their choleserol-lowering goal. Psyllium acheived target levels of cholesterol only 28% of the time versus 40% for statins (like simvastatin (Zocor), atorvastatin (Lipitor), and rosuvastatin (Crestor)). So while psyllium powder does lower cholesterol, its effects are modest and won't make your colon more beautiful. It is what it is.

I mean, really.

-Wes

64-Slice CT Predicts ER Outcome in Patients with Chest Pain

Today a single-center, prospective study from Israel was published that evaluated higher-resolution 64-slice multi-detector computed tomography (CT) scanning (MDCT) in patients with chest pain presenting to the Emergency Department. The study, published on-line in the journal Circulation, prospectively studied 58 patients with chest pain and no EKG or chemical evidence of cardiac injury that received MDCT scans to evaluate their coronary anatomy. 15 patients were classified as normal, 20 had mild, non-specific disease and 23 had significant coronary blockage (defined as greater than 50% occlusion) in at least one artery. The study demonstrated that MDCT had a 100% negative predictive value and 100% sensitivity (20/20) with a 92% specificity (32/38 patients) for a positive predictive value of 87% (20/23). Importantly, the study followed patients for 15 months after their ER discharge, and no deaths or heart attacks (myocardial infarctions) occurred in any of the 35 patients discharged from the Emergency Department after initial triage and MDCT. One patient had a late coronary intervention at 13 months after discharge of a distal circumflex coronary artery.

The study was limited by its relatively small size and its single-center experience. Additionally, patients with irregular heart rhythms (atrial fibrillation or frequent premature ventricular contractions) or rapid heart rate (>90 beats/min) were excluded.

Nonetheless, the potential for these scans to have a major impact on ER decision making, especially in patients with other equivocal risk factors and testing, is significant. Cost-effectiveness data are still needed, but the potential for limiting expensive cardiac admissions might be found to be cost-effective in the long run. It likely won’t be long before these scanners become standard equipment in Emergency Departments across the country – patients will demand it.

But there’s still one big barrier to implementation: we still have to secure insurance reimbursement for them… You can bet the Big Boys (like GE and Phillips) will be working on this...

-Wes

Confessions of a Prospective Juror

If you ever want to get out of a jury duty on a personal injury case, just tell ‘em you’re a doctor.

Being a neophyte to the judicial system, I found today’s brief experience interesting: just herd a bunch of bodies into a room, show them a quick video, and violá, you’re a juror!

Then you wait. I had drawn a '#6' from a big tin can as I entered and discovered I was with Group 6 of the juror pool. It didn’t take long until our group number was called with two other groups, forming one Big Group. “Well, at least I’ll see how this works,” I thought. We were soon headed off to a courtroom two-by-two and took our seats.

The case to review involved a rear end vehicular collision – your basic civil case – no blood-and-guts criminal case for me. (Thank goodness). We were cautioned that this was the real deal - no Judge Judy or Law and Order or any other drama - just the drama between two individuals with one trying to get compensated, handsomely, for a rear-end collision and another individual trying to send the other packing with nothing.

I realized from the outset I identified with the defendant. After all, a car accident happened, didn't it? But the plaintiff's lawyer was careful to never say that word... no, he was going to try to determine if there was negligence and malice on the part of the defendant. It's not okay to have an accident on the road. Everyone must be perfect - everyone must know the "Rules of the Road."

I swept the room. Both the plaintiff and defendant seemed like solid citizens. Both appeared to ambulate without difficulty (each had to retire to the restroom once). Both seemed to hate each other (glares were exchanged on more than one occassion). My diagnostic eye was in overdrive - I examined the plaintiff carefully accross the room: gait normal, uses both hands without difficulty, turns head without difficulty, leans forward to speak to her lawyer without screaming, no rubbing of the neck, posture appropriate. In retrospect, it's probably best to avoid the diagnostic endeavor, but it's hard - it's like a moth being drawn to the flame...

Needless to say, I was rejected before getting out of the starting block.

“It says here that you’re a physician?”

“Yes”

“What kind?”

“A cardiac electrophysiologist.”

Puzzled, the lawyer asks, “Is that like a cardiologist?”

“Yes, sir – an electrician for the heart if you will.”

“Have you ever treated patients for injuries after car accidents?”

“Yes, I used to be an emergency room physician for the United States Navy and treated many patients involved in car accidents.”

“Thank you, that will be all.”

Booooiiinnnggggg. Damn. Bounced out like a SuperBall on a hot, dry pavement. But it was still fun to see and participate in the process. I did get to sit through the jury selection process and observe. Soon the Lucky 14 were selected and we were dismissed. Here are a few of my revelations from my brief experience:

1) The accident involved occurred in 2002, and it’s now worked its way to a juried trial in 2007. Damn that’s a long time. I can’t imagine what the legal fees had been so far.

2) The verbal and communication skills coupled with the appearance of the lawyers matters greatly – at least to this prospective juror. The plaintiff’s lawyer remained seated during questioning of the jurors; the defense lawyer stood as he asked his questions – somehow, the defense attorney came off as more confident and secure.

3) Even where the jurors sat mattered, for reasons that were not clear to me.

4) Great lengths were made to assure the selection of jurors was truly random.

5) $17.20 is not enough pay per day for jurors.

6) In my non-scientific study, 14 initial jurors selected, ten (71%) had been in an auto accident some time in their life, and five (36%) had been involved in litigation for one of these accidents. Seems not everyone is perfect after all. Certainly, people have the right to sue their fellowman in our great country, and defendants have the right to due process. There will always be appropriate suits filed. But there still seems to lurk in the back of my head a feeling (especially when such potentially large sums are to be bestowed on the plaintiff while the defendant is happy to walk away with hefty legal fees), biases me to think that many try to take advantage of the system to make a buck. Lawyers, it seems, will never go out of business.

But the system as it is, worked. Although I did not get to stay for the trial, I pondered what I had been though. Somewhat reluctantly I reflected on the day and despite it all, I still feel damn proud of the judiciary here in the good ol' U.S. of A.

-Wes

Civic Duties

Off to fulfill my civic duty of Jury Duty today. Should be interesting...

Hopefully, I'll be back soon...

-Wes

A Hearty Donation

If you get a chance, stop by and congratulate Hsien-Hsien Lei, PhD on her one year anniversary of her blog A Hearty Life and read lots of pages for a good cause.

-Wes

I've Been Thinking...

Well, Dr. A. tagged me with the "Thinking Blog Award" - a meme that got me thinking... whom do I read that makes me stop, think, and appreciate their perspective and contributions to the medical blog-o-sphere? Well there are WAY too many to list here, but I thought I'd pick some of my favorites upon which to bestow this contagious and, er, 'cerebral' award. But there are a few, albeit simple, reguirements of this meme:

• Acknowledge the origin of this meme,


• If, and only if, you get tagged, write a post with links to 5 blogs that make you think,


• Optional: Proudly display the 'Thinking Blogger Award' with a link to the post that you wrote. A silver version of the award is available if gold doesn't fit the color scheme of your blog.

So here's my list:

The Blog That Ate Manhattan

Scalpel or Sword?

MedPundit

Angry Doctor

Emergiblog

Congratulations to all award winners! Now the onus is on you...

-Wes

The Biggest Loser

Before and After: Erik
Winner of last seasons' The Biggest Loser competition
Spring is in the air, and soon many of us will be heading for the great outdoors – especially the beach. But the winter months have taken their toll. Some might say “some settling of contents has occurred during shipment and handling…”

So to counteract the scourge of winter on our bodies, one of our doctors proposed we start our own Biggest Loser competition.

For those of you not familiar with The Biggest Loser, it has aired on NBC and showcases a number of individuals, all trying to lose the most weight. Like all reality TV shows, it’s definitely “made for TV” with plenty of anecdotes about dieting and exercise, but it’s become a phenomenon nonetheless.

So the members of our Electrophysiology section decided to have our own rendition of the same contest.

Last Monday, we all stepped on a scale and recorded our weight in scrubs only (no shoes). Each contestant will contribute $20 to the prize money. We have 15 people giving it their best shot over 12 weeks. At the end of that time, we'll record who’s the biggest loser in body weight based on a percentage of their starting weight. The winner will receive the money in the pot. We’ll also total up the total number of pounds lost as a group.

We’ll see what happens… one of our techs looks like he’s got a good start…

Think about this for your workplace. It might be the best thing you ever did as a team and for your health…

-Wes

Boston Scientific Plagued by Another Defibrillator Advisory

Just what Boston Scientific (BSX) didn't need was another advisory about their defibrillators: this one regarding prolonged charge times on the Vitality and Assure defibrillator (ICD) lines and the Contak Renewal biventricular cardiac resynchronization defibrillators (CRT-D) during their middle of life indicators.

This advisory occurred in Europe. The text of the advisory reads as follows:

The MHRA has received 31 reports of early explants from four of the above device models (1870, 1871, 1872, A135) during the middle-of-life (MOL) phase. Replacement has been due to observation of premature elective replacement / end of life indicators (ERI/EOL), caused by long capacitor charge times. The MHRA has also become aware of confusion about ERI/EOL indicators throughout implant duration.

Incident reports have included devices displaying:

• extended charge times where no replacement / end of life indicators have been observed
• ERI where charge times have extended beyond 26 seconds giving rise to potentially inappropriate therapy delay for some patients
• EOL indicators with charge times in excess of 30 seconds without ERI being observed in the first instance.

Boston Scientific ICDs / CRTDs are designed to regularly monitor both battery voltage and capacitor charge time, and flag ERI when specified limits are exceeded. Charge time ERI is flagged whenever two charges (capacitor reform or therapeutic shock) occur within a 24hr period in which both exceed the specified limit. Increase in charge time (due to a rise in battery impedance) is an expected behaviour of ICDs that have lithium-silver-vanadium-oxide batteries. However, early batteries used in some of the above models have a tendency to exhibit a more exaggerated increase in battery impedance during the MOL phase, due to a battery manufacturing anomaly.
Boston Scientific has confirmed that the above models have been programmed with temporarily extended ERI charge time limits during the MOL (middle of life) phase (compared to unaffected models). This is to prevent premature tripping of ERI due to the battery impedance characteristic. In January 2007, Boston Scientific issued a product update about this issue via their website. The company issued a more detailed and informative product update about this problem in March 2007. The MHRA is issuing this Medical Device Alert to ensure that all UK clinicians who implant these devices, or manage patients already implanted with these devices, are aware of Boston Scientific’s communication and can therefore consider the clinical implications of long charge times that may be inappropriate for some patients.

Action:
• Be aware of:
- extended capacitor charge times during device MOL phase, as documented in the most recent Boston Scientific product update (see the MHRA’s website for March 2007 issue)
- the higher prevalence of long charge times in earlier manufactured devices (see Appendix 2 below)
- the potential for earlier manufactured devices to pass from ERI to EOL in less than three months.
• At the next scheduled follow-up, review capacitor charge time history and evaluate the appropriateness of charge time according to patient condition and device dependency, giving priority to those who have not been followed up within the last three months (see Appendix 1 below).
• Consider the risks (infection etc) and benefits of elective device replacement where capacitor charge time is judged to be inappropriate for an individual patient.
• Consider scheduling future patient follow-ups at three monthly intervals – where the device is around MOL, to increase the likelihood of detecting longer charge times, early ERI and/or EOL as appropriate.
• Consider programming the ‘Beep When ERI is Reached’ feature to ‘ON’ (default) for all affected patients.
• Remind patients to contact their follow-up centre immediately if they hear beeping from their device and/or experience arrhythmias/resumption of symptoms that remain uncorrected by the device.
• Consult the Boston Scientific website for future related product updates.
• Report all instances of device failure to the MHRA and Boston Scientific.
• Report explants to the National Pacing and ICD Database.

For non-medicos: check with your doctor if you have one of the above ICD models. Fortunately, no deaths or significant injury have occurred with this advisory.

-Wes

March Madness

March Madness is not about basketball.

March Madness is what you get when you learn that Pfizer will pay it's vice chairman Karen Katen $76.8 million to step aside when she leaves the company and you find it is considered chump change compared to the nearly $200 million that Pfizer's Chief Executive Henry "Hank" McKinnell got when he decided to step aside.

But this commentator to the above blog put this all in perspective:

What’s worse: Katen’s millions for running what was considered by many as the greatest Rx company in history OR paying drug reps $75,000+ a year to leave their house after 10am grab 10 quick signatures (never selling a thing!), spending $400 on lunch every day, then going home at 3pm. Get a clue! The whole industry is screwed up.

-Wes

CPR: Bag the Breathing?

The ABC's of cardiopulmonary resusitation (CPR) might get scrambled: instead of "airway-breathing-circulation" as the cornerstone of CPR, maybe we should think "compression, compression, compression" and bag the breathing:

Ken Nagao of Surugadai Nihon University Hospital in Tokyo and colleagues compared how well more than 4,000 adults fared after receiving traditional CPR, the chest-compressions only approach, or no CPR at all until paramedics arrived.

Patients who received only chest compressions had less brain damage than those who got compressions and breaths, the team reported in Saturday's issue of the medical journal The Lancet. Not surprisingly, patients who had no CPR had the poorest outcomes.

The researchers suspect breaths may be detrimental if there is only one person performing CPR, because the mouth-to-mouth breathing takes precious time away from chest compressions that bring blood to the heart and brain.

-Wes

Reference: Cardiopulmonary resuscitation by bystanders with chest compression only (SOS-KANTO): an observational study. The Lancet 2007; 369:920-926. DOI:10.1016/S0140-6736(07)60451-6

In Cardiac Arrest, Higher Defibrillation Energies Are Better

Take any drug, give more of it, then usually you’ll see a bigger physiologic response. Most of us in medical school knew this as a dose-response curve.

As a cardiac electrophysiologist, I have always been interested (but never had the patience to test) why the American Heart Association’s guidelines were always suggesting “start low and work your way up” with defibrillation (shock) energies when a patient has the life-threatening heart rhythm disturbance, ventricular fibrillation. During ventricular fibrillation, the heart is only barely quivering and generates no effective cardiac output or blood pressure. Time is of the essence when correcting this arrhythmia to improve patient survival: without cardiopulmonary resuscitation (CPR) during ventricular fibrillation, irreversible brain injury can begin in just four to five minutes.

So it was refreshing to see the results of the effectiveness of out-of-hospital defibrillation with two different energy regimens tested side-by-side by Canadian researchers in this month’s Circulation. They compared fixed lower (150J-150J-150J) defibrillation versus higher escalating doses of defibrillation (200J-300J-360J) in 221 patients requiring more than one shock with a biphasic defibrillator during out-of-hospital cardiac arrest. Their results were predictable: higher energies work better. Much better. 25% vs. 37% better (p<0.035).

The dose-response curve held true: improved success was seen when higher defibrillation energies were applied.

Now the question becomes, why not just start delivering shocks at the maximum output of the defibrillators during cardiac arrest? If a 10% improvement was seen with escalating doses of defibrillation, could additional success be identified using a fixed maximum defibrillation energy? In animals, it has been demonstrated that ventricular fibrillation in the setting of acute ischemia (lack of blood flow to the heart) requires higher energies to achieve successful defibrillation than non-ischemic ventricular fibrillation.

I guess we’ll have to wait for another study for my answer. But for now, dial up those defibrillators when shocking ventricular fibrillation.

-Wes

Seasons of Dough

Seasons of Dough
(With apologies to the Cast of Rent)
(Play Midi in background)
Based on a true story.

Five hundred twenty-five thousand six hundred dollars
Five hundred twenty-five thousand doses they fear
Five hundred twenty-five thousand six hundred dollars
How do they profit,
profit all year?

You bill them, quite nicely, in Euros, and Lira,
In Yen and Pounds Sterling, for drugs in their I. V.
Five hundred twenty-five thousand six hundred dollars,
how do you measure the cost of a life?
Give me a break!
Give me a break!
When will it end?
Leave ‘em some dough
Be a good Joe.

Five hundred twenty-five thousand six hundred dollars
Five hundred twenty-five thousand bills if you can
Five hundred twenty-five thousand six hundred dollars
How can you measure the cost of a woman or man?
In truths that she learned, or in times that she cried
In bridges big pharma*, burned for their pride.

Its time now to sing out, though the story never ends
Profits are one thing, but the costs are too high
Remember the sole
Remember the sole
It’s taking a toll
Leave ‘em some dough
Be a good Joe.

-Wes

* Per-patient Costs of IV Cancer Drugs:
Avastin (Genentech): $46,600
Vectibix (Amgen): $36,000
Erbitux (ImClone & Bristol): $40,000
Lucentis (Genentech): $48,000
Revlimid (Celgene): $67,000
Sutent (Pfizer): $46,500

(Source: WSJ 3/15/07)

Smoking Ban Makes Coffee Stands Get Steamy

An unexpected result of Washington state's smoking ban: Starbucks gets some steamy competition:

When the (Washington) state's smoking ban went into effect last year, many bar, casino and convenience-store owners sought to make up for expected losses by renting part of their parking lots to espresso stands, said Lori Bowden, owner of the Cowgirls Espresso stands.

The advent of "sexpresso" is harder to track. Business and baristas debate over who pioneered the edgy outfits, but they agree that by sweetening the product, with a smile and maybe a shot of hazelnut syrup, they've reached out to customers who've never set foot in a Starbucks.

Drive-throughs are a growing part of Starbucks' business, too, with more than 1,500 drive-through locations throughout the United States. But a representative of the company said it has no plans to sex up the dress code, as it wouldn't fit the company's brand.

At places such as Cowgirls, the barista is the brand.

"If I'm going to pay $4 for a cup of coffee" said one male customer, "I'm not going to get served by a guy."

Who would have thought...

-Wes

New AHA Guidelines for Screening Athletes Excludes EKG

The new recommendations for screening of athletes for competitive sports was issued by the American Heart Association and endorsed by the Americal College of Cardiology yesterday in the journal Circulation and includes careful evaluation of personal symptoms of the patient, family history, and physical examination findings. The recommendations significantly differ from the European Society of Cardiology (ESC) and the International Olympic Committee (IOC) by excluding the requirement of an electrocardiogram (EKG).

Although the Switzerland-based IOC and the ESC have advocated that all young competitive athletes be screened routinely with a 12-lead ECG (in addition to history-taking and physical examination), the updated 2007 AHA guidelines do not make this recommendation. No federal or state laws currently mandate that American physicians adopt the ESC16 and IOC guidelines. American law permits US medical organizations and physicians to assess independently the relevant variables (including the current infeasibility of routinely performing ECGs on populations of asymptomatic US athletes) and to make their own recommendations about the appropriate nature and scope of cardiovascular screening. Thus, a US physician’s decision to follow the updated AHA recommendations rather than those of the ESC and IOC does not itself constitute medical malpractice.

Part of the reason for exclusion of the EKG from screening is logistics.

For the AHA to officially adopt (or even condone) the ESC screening recommendation for routine ECGs without a reasonable expectation that such a program could be implemented in the near future could have a paradoxic, chilling effect on US preparticipation screening. Practitioners involved with screening would be potentially compromised by being unable to comply with the proposed screening strategy incorporating an ECG. Therefore, it is possible that the willingness of qualified US physicians to participate in screening would be reduced if the ESC/IOC recommendations were mandated.

Part of the reason for the exlusion of the EKG is cost:

Given the theoretical cost of a mass cardiovascular screening program of $2 billion per year, the dollar amount attached to detecting each athlete with the suspected relevant cardiac diseases would be $330 000. Assuming that (more than) 10% of these 9000 athletes with cardiac disease (1800) would harbor evidence of increased risk for sudden death, then the cost of preventing each theoretical death would be $3.4 million. We recognize that some may not regard these estimated costs per athlete as excessive for detecting potentially lethal cardiovascular disease in young people; however, the fundamental issue defined by these calculations concerns the practicality and feasibility of establishing a continuous annual national program for many years at a cost of approximately $2 billion per year.

They conclude as follows:

Indeed, on humanitarian medical grounds, the AHA supports any public health initiative with the potential to identify adverse cardiac abnormalities. On the other hand, because the panel cannot ignore the many epidemiological, social, economic, and other issues that impact this screening proposal, it must view the European model in realistic terms from a US perspective. Therefore, for a number of reasons, it is difficult to consider the European-Italian strategy as potentially applicable to preparticipation screening in the United States.

So, although the EKG is out, practitioners must not forget to take a thorough personal and family history, listen for murmurs, check the blood pressure from the arm, check for femoral pulses in the legs (to exclude coarctation of the aorta), and note physical characteristics of Marfan's Syndrome.

-Wes

Simvastatin Costs Vary Widely

Click chart to enlarge
This chart appeared in the Wall Street Journal this AM and discloses the remarkable variation in price on some generic drugs between pharmaceutical outlets. I was particularly struck by the cost variations of generic simvastatin (Zocor) between pharmacies.

But this quote was of particular interest:

Chain drugstores argue that their business model is different from a company like Costco or Sam's Club. CVS, Rite Aid and Walgreen Co. all say that about two-thirds of their revenues come from prescription drugs.

"We don't sell snow tires," says Mike DeAngelis, a spokesman for CVS/pharmacy. "The core of our business is the pharmacy."

Now that the word has gotten out and people run to Costco and Sam's Club, CVS might want to rethink the snow tire angle.

-Wes

P.S.: Another helpful site for drug price comparisons: Destinationrx.com.

So You Want to Keep Being a Millionaire?...

Regis wisely decides to have his bypass.

-Wes

Hospital Ad Wars: Data Mining for Bragging Rights

As hosptial outcome data become increasingly available, will patients be able to sort out which hospital system can boast they're "the best?"

-Wes

Warning: Milk Might Be Harmful to Children

How would you like that headline on your dairy case? Or instead of "Got Milk?" on posters, they end up reading "Got Trans Fat?" No doubt the trans fat ban enthusiasts would love to extend the ban to include all things dairy and beef, if they could. The insistence by law that all bakeries in New York must ban butter due to its high trans fat content is having an interesting ripple effect with the public - maybe there's too much government intervention here at controlling people's diet. Maybe there's little data to support the claims that people, not lab rats, will have a lower incidence of heart disease with the implementation of a trans fat ban.

Imagine if the New York City government were to ban the Adkin's diet because it contains too much trans fat? Would we want that, too? I would find that intervention too excessive, alright, especially given the recent study that the Adkin's diet with its highest protein and fats (yes, trans fats, too) was the most effective at promoting weight loss and lowering blood pressure amongst four popular diets tested head-to-head over a 12-month period. Interestingly, other studies in 2002 have demonstrated that the Adkin's diet was also more effective at lowering serum cholesterol that the American Heart Association's recommended diet as well.

But how does one explain this? How could a diet high in fats and protein possibly promote weight loss?

It's simple: because weight loss is not dependent on the fat content of our food. Rather, it is most associated with the presence of the anabolic hormone insulin. Insulin is a major determinant of the sensation of hunger and converting carbohydrates to fat. Adkins knew this. He promoted it for years. But many wouldn't listen. His theory flew in the face of the various dietary groups promoting quick, ready-to-eat, nutritious breakfasts with lots of vitamins and nutrients (and carbohydrates). Remember Carnation "Instant Breakfast?" Stirred with milk, you had the fast and furious super-sweet breakfast that gave you the energy and nutrients to conquer the day! And enough carbohydrates (24 grams even in their no added sugar variety) to stimulate the additional secretion of insulin to stimulate hunger after the bolus of carbohydrates was resorbed so you'd want to eat more and pack on the pounds!

Obesity and weight gain are directly correlated to the development of hypertension, diabetes, and the "metabolic syndrome," and as such, are significant contributors to the development of cardiovascular disease. Certainly genetics play a role, too. But whether the trans fat ban will have any effect on the improvement in the obesity epidemic by promoting increased carbohydrate consumption in America remains doubtful.

-Wes

Time to Surrender

Think you've had a big day? Check out this poor guy...



-Wes

FDA to Review Off-Label Use of Biliary Stents

Showing an ever-growing presence in the post-market medical device arena, it now appears that the FDA is going after biliary stent manufacturers to review “off-label” use of these devices to prop open larger blood vessels.

Tiny bile-duct scaffolds, known formally as biliary stents, are supposed to prop open the tubes that carry digestive fluids to the intestines, as opposed to blood-pumping arteries, which are the province of stents approved for vascular uses, including drug-coated coronary stents used near the heart.

But since biliary stents are available in much larger sizes than their vascular cousins, doctors commonly use them to prop open large arteries, such as those leading to the legs and kidneys. "Our go-to stent for disease in the legs are biliary stents," said Dr. Gary L. Schaer, the director of the cardiac-catheterization laboratory at Rush Hospital in Chicago. A September 2006 article by an FDA scientist also concluded that "virtually all" kidney-artery operations used stents not approved for that purpose.

Some industry sources estimate that as much as 90% of biliary stents are sold to catheterization laboratories and used off-label in arteries. On-label sales of biliary stents amounted to about $38 million last year, according to Millennium Research Group. Those numbers don't include off-label use in arteries.

Government intervention for patient safety is critically important, especially when the use of drugs or devices shows significant harm to patients. But government intervention in health care also may threaten the very way medicine is practiced today.

In the case of biliary stents, doctors devised a creative solution to a difficult clinical conundrum (resolving blockage in a large artery when no FDA-approved tool exists) that has helped many patients avoid significant complications from major surgery. When these doctors compared the results of a minimally-invasive approach to the difficulties their patients had with major open surgical procedures like infection/wound healing, etc, they were hooked. The biliary stent companies responded to the demand in kind.

The situation is analogous to the early days of catheter ablation. As an electrophysiologist, I can vividly recall the conundrum the FDA was placed in when catheter ablation burst onto the scene of cardiac arrhythmia management. Doctors recognized then that significant risks existed with open heart surgery for surgical arrhythmia management and felt (correctly) that the morbidity and mortality of off-label catheters for catheter ablation was safer for their patients.

But now, if the FDA restricts the sale of these stents to patients when no properly-labeled alternative exists on the market, will physicians be forced to change their practice and take a giant leap backward in patient care management in the interest of proper FDA labeling practices?

And why stop with stent manufacturers? Is the FDA going to extend their reach still further? What about off-label drug use?

Physicians have a long history of off-label drug use. Take the drug amiodarone, for instance. Amiodarone is the most commonly prescribed (and effective) antiarrhythmic medication prescribed for atrial fibrillation, an irregular heart rhythm of the upper heart chambers, but is not approved for this indication. Could the FDA force manufacturers to go back to the drawing board before sales for such drugs are permitted for "off-label" indications?

This would set an ominous new precedent for physicians and their patients. It would also set an ominous new precedent for the medical device and pharmaceutical industry. Worse still, it would set a new precedent for the legal industry to proceed to litigate every off-label complication that occurs to a patient - be it drug or device.

-Wes

Nary a Hair Anywhere

Hilarious and a bit scary. Not hairy. Just scary.

Philips takes body grooming to a whole new level. Be sure to have the sound on and make sure you check out the accompanying music video by clicking "Menu."

(I'm still laughing...)

A Heart Nailed

Unlike Steve Irwin, who removed a sting ray's barb from his chest and died, this teen presented to the ER with a nail to his chest and wisely did not remove it. Some cool spiral CT images and video of the teen are included in the link.

Moral of the story: if it penetrates the chest, leave it in place pending surgical removal.

-Wes

Mixed Messages

What happens when the American Heart Association pairs with Rite-Aide drug stores.

-Wes

via PRWatch.

McDonald's New Sandwich a Whopper

With the introduction of the “Angus Third” sandwich from McDonald's in California, beef-lovers will rejoice but the trans fat food Nazi’s will swoon. My children, on the other hand, will appreciate McDonald's donating to their college fund. After all, we’ll give America more calories (720-860 per sandwich) to support the obesity epidemic and provide America with another delicious source of saturated and trans fats.

It give's a new meaning to Where's the Beef?

Oh, well. Just have it your way.

Thanks, McDonald's.

-Wes

PS: Oh, who’s going to tell New York City that beef contains trans fats??? Think they'll be able to sell the Angus Third there?

16:45 8 Mar 2007 Addendum: Why not go all out, like these guys do.

Door-to-Balloon Time - Perfecting the Data

Nothing sells papers like bad news.

And no one wants to have bad news shared with the world, especially when you’re a hospital and especially when people can compare your hospital to other hospitals.

So yesterday, this article from the New York Times was brought to my attention. It is a “response” from hospitals found to have the “worst” heart attack care as measured by door-to-balloon times by the government’s "Hospital Compare" database. You see, the New York Times wanted to sell papers, so the New York Times reviewed the database and published the data in the papers, and lots of the “worst” hospitals were offered a chance to “respond” to the article and give their excuse why their data were less than perfect compared to other hospitals. Here's one such response:

John Easton, spokesman, University of Chicago Medical Center: "As an academic medical center on the South Side of Chicago serving a large indigent population, we faced several uncommon hurdles in minimizing the time it takes to assess patients in the emergency room, move them quickly to the catheterization laboratory and initiate definitive care. These include a disproportionate number of patients with co-morbid conditions — such as stroke, respiratory failure requiring intubation, or cardiac arrest requiring resuscitation — which require immediate treatment prior to transfer to the cath lab. We also see uncommonly frequent patient refusal to undergo angiography immediately. In recognition of the impact of such cases, Medicare recently developed systems that allow hospitals like ours to document and exclude these outlier cases. Despite these hurdles, our door-to balloon times have vastly improved in the last year thanks to an aggressive systems approach. Our average time for the last 10 cases in the database (up to December 2006) was 94.4 minutes. From July 1, 2006, until now, 80 percent of patients had a door-to-balloon time of less than 90 minutes, and 100 percent were treated within 120 minutes."

Now all cardiologists understand the importance of opening an artery in the throws of an acute heart attack. Time is muscle. There is no question that hospitals need to make it a priority to open arteries as quickly as possible. In fact, this was felt to be so important that the American College of Cardiology initiated their “Door-to-Balloon - D2B” as a measure to assure excellent care. And the department of Health and Human Services added the criteria of door-to-balloon time to their database to assure that hospitals are providing exceptional heart attack care and provide incentives to hospital in terms of higher Medicare reimbursements to reward “quality.” Fair enough.

But when hospitals get embarrassed publicly once the data are actually used, they are forced to improve their data. So the natural consequence of these disclosures is that hospitals must change something quickly to assure they aren't on the CMS's blacklist. So the question becomes, is patient care at these centers improving or are the data collection and reporting improving by becoming more selective?

Here’s how I see this. Data using all patients' door-to-balloon times were initially entered into the government’s database in a differential fashion between centers. Some centers entered all of their patients that presented with heart attacks, others use highly "selective" criteria about whom to include in the reporting. These data are then exposed to the world in the New York Times. Hospitals are embarrassed and devise ways to improve their data using “aggressive systems approaches” to look good. Data become meaningless. Hospitals (and states) can use meaningless data to promote how great they are. Medicare decides to pay these hospitals because they have corrected the way they collect the data to make the data look good.

Everyone wins.

Except the patient. You see to avoid embarrasment and to ensure reimbursement from Medicare, all data will eventually skew toward “perfection” in the interest of marketing and payment forces.

So, how could hospitals possibly do this? Well, you get better at collecting data. You see, your “aggressive systems approach” looks carefully at the ACC guidelines and notes there are these helpful “exclusions” so the data collection teams can “exclude” reporting on patients that did not receive an angioplasty in 120 minutes because:

• Traffic was bad and prevented the angioplasty team from getting to the hospital in time
• Patient initially refused the procedure
• Angioplasty held due to concerns about possible aortic dissection
• Patient wanted to wait for family or clergy to arrive.
Patient had to be defibrillated several times before transfer to the lab
• Patient arrived in full cardiac arrest

You employ people to make sure that they find as many exclusions as possible to assure the data look good. Oh, and if your EKG doesn’t show ST segment elevation, then you don’t have to include those either - like posterior infarctions that rarely demonstrate ST segment elevation. But hey, it’s all about the quality of the data, isn’t it?

-Wes

How the Rich Get Richer

From the Wall Street Journal this am:

In its SEC filing yesterday, UnitedHealth stated that it had "used incorrect measurement dates and made other errors...in accounting for stock option grants." The company said it had found incorrect dates for grants involving roughly 80 million shares given to top company officers, about 260 million shares granted to senior and middle management and another 50 million shares tied to hiring or promoting other employees.

Based on UnitedHealth's historical accounting method -- in effect until the start of 2006 -- the resulting changes in stock-based compensation lowered earnings by a total $1.13 billion.

Amazing. Unitedhealth pays $1.13 billion to get out of its options mess, and its stock goes up three percent. In a company valued at $71.54 billion, that represents an increase in valuation of $2.15 billion.

They're getting off cheap and making money at it.

-Wes