Every time I hear the sound of my recorded voice, I am reminded why I write so much. I am still quite rough at the edges. Nevertheless, I've had the courage to do another podcast, this time with John Carey, senior correspondent at BusinessWeek.
Cholesterol and statins have been in the news a good deal lately. Last week, I wrote about the study release about Vytorin, calling into question whether or not it was effective in preventing heart attacks. The Forbes article headline was that "Study Shows Vytorin Has No Benefit" even though there are emerging studies that demonstrate or suggest other possibilities.
The January 28, 2008 cover story of BusinessWeek ran a story the title of which raises the question without having the same conviction as the Forbes article. It is by John Carey entitled "Do Cholesterol Drugs Do Any Good?"
It is a provocative article that does ask important questions. In it, John Carey explores the efficacy claims of cholesterol drugs when viewed through the lens of the "Number Needed to Treat" (NNT) - which means how many people actually have to take a drug before there is someone who sees a benefit.
The article suggests that the way we traditionally evaluate and promote efficacy may be by means of too blunt an instrument.
On the other hand, also this month, data was released to show that deaths from heart attacks and stroke have plummeted in this country - as well as studies that speculate whether there is a role for statins in cancer prevention. Coincident with that drop has been an uptake in the long-term use of statins among other things, such as improvements in treatment of heart attack and stroke patients.
Few public health messages have been pounded into consumers heads more than that which says lower cholesterol lowers your risk for heart attack. I invite you to listen to Mr. Carey as we discuss his article, the role of blockbuster drugs and what this might mean for the future.
And for communicators, whether you agree with the points raised in the article or not, the discussion raises new questions about how we talk about benefits and efficacy - questions that need to be answered. Will, for example, NNT capture the role of statins, if any, in the longer term statistics (from 1999-2005) that show a 25% drop in heart attack and stroke deaths? What should be included in the mix when we define benefit and when we define risk?
I had the opportunity, thanks to colleague Ben Finzel, to sit down with Mr. Carey and discuss just a few of the ramifications of these questions:
I also have high cholesterol, but being in the healthcare marketing industry I have good insight into the category. Let me be clear. No one who knows anything at all is seriously questioning the benefits of statins. They have been proven beyond a shadow of a doubt over and over. Period.
Zetia on the other hand is not a statin. And while its ability to further lower LDL when added to a statin is well-established, the benefit of this has never been proven. Hence ENHANCE.
What ENHANCE showed is that adding Zetia to Zocor may not offer additional protection (based on the crude measurement of plaque accumulation in the carotid artery). So Zocor alone may be just as good. The protective effect of Zocor is in no way being cast in to doubt by this or any other study.
The real issue with Vytorin is a classic case of practicing "assumptive medicine" by physicians. Since lowering LDL with statins is proven to reduce
cardiovascular risk, and lowering more with statins shows greater risk reduction, the assumption has always been that the act of lowering LDL is what's protective. Now we see that lowering with STATINS is protective. That's why we do the studies.
The risks of statin therapy are really small. Just have the liver monitoring done early on and then annually. The benefits are so proven. As much or more as any other class of chronic treatment in any category.
I recommend the South Beach Heart Program by Arthur Agoston, the author of the South Beach Diet. He's a leading cardiologist who specializes in preventative cardiology. If you read his book, you will take your statin, I promise.
Posted by: Theodore Whitby | February 14, 2008 at 10:18 AM