With Prevention, The Sky's the Limit

Jupiter (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), Astra-Zeneca's tour de force cholesterol-treatment trial, was released at the American Heart Association's national meeting yesterday and simultaneously published online yesterday. It's the talk of the town.

Especially in Boston.

That's where the study's lead investigator and the Brigham and Women's Hospital that holds patents on the c-reactive protein tests used to screen the 89,000-plus people for the 17,800 people enrolled in the trial are from. They're lovin' life right now.

Imagine inventing a test can be applied as a "screening test" on about 30 billion million people to find the 6 billionmillion or so people annually who would be benefitted by the prevention measure. Imagine making $1250 per year per person on the sale of your statin. Imagine that twenty five such individuals will have to be treated for five years with the statin to prevent one cardiovascular event.

Imagine.

This is not to say that the results of the trial are not impressive. To demonstrate a near 50 percent reduction in cardiovascular events in a carefully selected low-risk population for cardiovascular events is impressive. Really.

But at what price comes such preventative measures to our health care system?

If we assume that a 20-mg daily rosuvastatin (Crestor) tablet costs $107 per month to treat the average patient, and that twenty five patients have to be treated for five years to prevent one cardiovascular complication (and this does not include the annual liver function tests, the cholesterol tests, the C-reactive protein checks, etc), we begin to focus on an inevitable realization: that prevention is a remarkably expensive way to deal with our exploding health care costs.

For instance, if we assume that 25 people would have to be treated with Crestor for five years to prevent one cardiovacular event (as the study suggests), we can estimate the following back-of-the-envelope costs:

• Lipid level evaluation ($150 per test x 5 years) = $750
• C-reactive protein level $20 per year x 5 years = $100
• Annual liver function tests: $250 per test per year x 5 years = $1250
• Annual Crestor costs ($107 per month x 12 months per year x 5 years) = $6420
• Number of people needing to be treated over 5 years to prevent one cardiovascular event: 25
• TOTAL DOLLARS TO SAVE ONE CARDIOVASCULAR EVENT: $213,000

Applying these costs to the population that is thought to be at "risk" (some 6 to 10 billion million people), if every person were given this therapy, the cost to our health care system would implement this single prevention measure would amount to a whopping $51.12 trillion billion dollars over five years.*

Hey, if I owned stock in Astra Zeneca, I'd be "all in," too. But my simple calculations lead me to wonder if such prevention measures are the way to fix our current health care cost crisis.

I don't think so.

-Wes

*$213,000 per 25 people treated = $8,520 dollars per person treated over 5 years.
6 billion million people treated for five years x $8,520 dollars per person = $51,120,000,000.

Addendum 13:25 CST - Calculation corrections made. Thanks to Yoni and anony 12:18 who pointed out my error.

Marketing Accurate Empathy

Meanwhile, back in the AstraZeneca marketing department:

"Hey, Joe, I got an AWESOME idea! We've got a few hundred thousand extra bucks lying around, right? Let's get some trucks! I mean, we could drive 'em around and burn some diesel, and pull right up to hospitals all over the frickin' country, man!"

"Dude, why didn't I think of that? Like, that's so frickin' coooool!"

"Yeah, man, like, we can say things abut heart failure, like:

"It’s the number one reason why people over age 65 are admitted to hospitals. For that reason alone, it’s important to raise awareness of Congestive Heart Failure and help healthcare professionals recognize and understand its symptoms."

"Man, we'd sound so, so, I mean, authoritative, man! And sooo, since doctors have no clue how to diagnose heart failure and since they need to be using more of our drugs like Zestril, Toprol XL, and Atacand, like, DUDE, it'll be frickin' awesome to suffocate them with a pneumatic vest connected to a Mac computer and make 'em beg for our drugs! Then they'd HAVE to use 'em! And once we let 'em tour the driver's front cabin, they'll want to even drive the frickin' truck!" (* giggling loudly *)

"Dude, like, how big a truck's that gonna take for one simulator, man?"

"Like, I dunno, but hey, man, they got these cool expandable sides. Here's an idea that I thought would work, so I had 'em make a prototype..."

"No waaaayyyyy...."

"Waaayyyy!!!! Here, look:"



"Oh, Dude, you're so awesome. Can't wait to see those marketing numbers soar! It's gonna be soooo phat!"

"Dude, can I ride your coattails when you become our next CEO?"

"Heh, yeah man.... Hey, you doin' NASCAR this weekend?"

Meanwhile, back in the heart failure patient's kitchen, the USA Today arrives:

Drug companies are quietly pushing through price hikes of 100% — or even more than 1,000% — for a very small but growing number of prescription drugs, helping to drive up costs for insurers, patients and government programs.

"Whoa, DUDE! Somebody's gotta pay for the truck..."

-Wes

h/t: Medgadget.

Current Data on Risk Stratification for Sudden Cardiac Death

Some interesting results of an industry-sponsored expert conference on risk stratification of sudden death appeared in this month's American Heart Journal. The experts reviewed left ventricular ejection fraction (LVEF), New York Heart Association Class, the presence of nonsustained ventricular tachycardia, microwave T wave alternans, measures of cardiac autonomic modilation (like heart rate variability), QT interval variability, signal averaged EKG, electrophysiology study, genetic testing, imaging studies and serum markers (like brain naturetic peptide or c-reactive protein).

Their take? Only ejection fraction seems worthy for risk stratification so far.

Here's what they said about ejection fraction:

The LVEF has been recognized as a predictor of all-cause mortality in patients with coronary artery disease (CAD) for >30 years. One early study by the Multicenter Postinfarction Research Group showed in 866 post–myocardial infarction (MI) patients that the strongest predictor of 1-year cardiac mortality was the LVEF. This finding has withstood the test of time. In the VALIANT (trial), a randomized comparison of captopril, valsartan, and their combination in post-MI patients (n = 14 609) with left ventricular dysfunction, CHF, or both, LVEF was a strong predictor of SCD or cardiac arrest. The risk of SCD or cardiac arrest increased by 21% for every 5% decrease in LVEF.

Left ventricular ejection fraction is also a strong predictor of all-cause mortality in patients with nonischemic cardiomyopathy. The MACAS (trial) was a prospective cohort study of 343 patients with nonischemic cardiomyopathy and an LVEF ≤45% who were followed for a mean of 52 months. Left ventricular ejection fraction was the only significant predictor of major arrhythmic events with a relative risk (RR) of 2.3 per 10% decrease in LVEF (95% CI 1.5-3.3, P < .0001) in patients with sinus rhythm and 4.5 per 10% decrease in LVEF (95% CI 1.5-13.2, P = .0008) in patients with atrial fibrillation.

Participants at the meeting were as follows:

Participants from the Academia: Sana M Al-Khatib, MD, MHS (co-Director), J Thomas Bigger, MD, Alfred Buxton, MD, Robert M Califf, MD, Anne Curtis, MD, Jeptha Curtis, MD, Bernard J. Gersh, MB, ChB, DPhil, Michael R. Gold, MD, PhD, Jeff Goldberger, MD, Stephen C. Hammill, MD, Jeff Healey, MD, MS, Mark Hlatky, MD, Stefan Hohnloser, MD, Raymond J Kim, MD, Kerry Lee, PhD, Daniel Mark, MD, MPH, L. Brent Mitchell, MD, Eric Prystowsky, MD, Gillian Sanders, PhD (co-Director), and Wojciech Zareba, MD, PhD

Participants from the Centers for Medicare and Medicaid Services: Steve Phurrough, MD, MPA

Participants from the US Food and Drug Administration: Norman Stockbridge, MD, PhD, Robert Temple, MD, Bram Zuckerman, MD

Participant from the National Institutes of Health: Robin Boineau, MD, Michael Domanski, MD

Participant from Agency for Healthcare Research and Quality: Elise Berliner, PhD

Participant from the Heart Rhythm Society staff: Joel Harder

Participants from Industry: Mark Carlson, MD, Eric Fain, MD, Ali Haghighi-Mood, PhD, Steve Ketchum, PhD, Steve McQuillan MS, Marcus Mianulli MA, Philip Sager, MD, Dan Schaber, PharmD, Robert Shalwitz, MD, Joseph Smith, MD, PhD, Michael A Stein, MD, David Steinhaus, MD

Coordinating Staff: Marelle Molbert and Cass Finley from the Duke Clinical Research Institute.

The conference was funded by AstraZeneca, Bayer, Boston Scientific, Cambridge Heart Inc, Medtronic, Reliant Pharmaceuticals, St Jude Medical.

-Wes