The story of Big League Chew starts in a bullpen, where two pitchers didn't like players' habit of chewing tobacco.
New guidelines out this week by the American Heart Association and the American College of Cardiology dramatically broaden the definition of patients at risk for heart attack and stroke, and recommend the use of statins for about 35 million new patients.
The guidelines change the way doctors will assess the risk of patients, and urge them to use statins to prevent disease in many more patients now perceived to be at risk for heart attack and stroke.
Dr. Steven Nissen, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, joins Here & Now’s Meghna Chakrabarti.
MEGHNA CHAKRABARTI, HOST:
It's HERE AND NOW. Cardiologists have long told Americans to get their LDL, or bad cholesterol, levels down as much as possible, and they've often described - or prescribed statins or cholesterol-lowering drugs to help. One in four Americans over 40 already take statins, but that number is about to get much, much larger because this week, the American College of Cardiology and the American Heart Association introduced new guidelines that could double the number of people who take statins.
It's the biggest shift in thinking about preventing heart attacks and strokes in 30 years. Dr. Steven Nissen joins us now to explain. He's chairman of cardiovascular medicine at the Cleveland Clinic. Dr. Nissen, welcome.
STEVEN NISSEN: Thank you very much. It's good to be here.
CHAKRABARTI: So we should say that you're not an official member of the panel that made these recommendations, but you are one of the nation's experts on cardiovascular medicine. So first of all, how significant do you think this shift is in how we think about statins and cardiovascular disease?
NISSEN: Well, it's huge. This is really the biggest change in the guidelines that we've seen certainly in any time that I can remember. I refer to it as a tectonic shift. And it's a shift not because merely that it involves treating more people, but the way we select those patients for treatment is different now.
We don't select them based so much on their cholesterol levels; we select them based upon their level of risk. And so it doesn't matter as much what the numbers are. It's about who to treat and who not to treat.
CHAKRABARTI: Well, let's talk about that a little bit more in detail to help people understand because everyone's pretty much familiar with, you know, getting their blood taken and seeing what that LDL number is, and then the doctor says well, you don't - you're above, what, 190, so we need to put you on statins. What do the new guidelines specifically look at if not that?
NISSEN: Well, they identify four groups. First of all, there are certain people that have a genetic disorder that leads to very high levels of LDL, or bad cholesterol. A level of greater than 190 is an indication for treatment regardless of other risk factors.
There are three other groups. If you have type 1 or type 2 diabetes, either the juvenile form or the adult form of diabetes, you should be taking a statin drug according to the new guidelines. And if you have known heart disease, heart or vascular disease, meaning, you know, you've had a heart attack, or you've had a stroke, or you've had an angioplasty or bypass surgery or disease in your carotid arteries in the neck, you should be on a statin.
The fourth group is the most controversial. There is a new risk calculator that the authors of the guidelines developed. You plug your data into that, your demographic data, your age and gender and race and some other numbers like your blood pressure. It calculates your risk over the next 10 years, and if you have greater than a seven and a half percent risk of having heart disease develop, then it's recommended that you take a statin. And again, that's pretty much regardless of what your levels of LDL cholesterol are.
CHAKRABARTI: OK, so I've been reading that Dr. Neil Stone(ph), who's the chief author of these new guidelines, he's saying that Americans' health overall is going to benefit from this more vigorous approach because, quote, statins treat risk, not only cholesterol. Is that what he's talking about? And if so, why is it so controversial, as you said?
NISSEN: Well, the controversy is more about where that border is between who you treat and who you don't treat. They set the threshold at seven and a half percent risk. Other people might have suggested setting it a little higher, at 10 percent. There will be some controversy over the calculator because no calculator is perfect.
And it is important for our listeners to understand that these are guidelines. They're not mandates. They're not absolutes, although they're very good recommendations. It's always a good idea to individualize care and to talk with your doctor about your individual situation.
Some people may not tolerate statins very well, and so we do have to think about these things. We can't just, you know, make this a knee-jerk response based upon the guidelines.
CHAKRABARTI: I'm seeing that, you know, a huge number of Americans already take statins, one in four Americans over the age of 40. If these guidelines are applied as rigorously as the panel hopes, we could see something, you know, around 70 million Americans being recommended to take this drug. And I'm also, I'm seeing that, you know, because of what you said, the risk calculator, that for example people that don't have high LDL or bad cholesterol levels but do have other risk factors like smoking or moderately elevated blood pressure, could qualify for being put on statins.
Do you think that these new guidelines have cast too wide a net?
NISSEN: I don't necessarily think so. We have good scientific evidence. There was a very large study known as HPS, the Heart Protection Study, that looked at statins in one group of patients versus placebo, a sugar pill, in the other. And it didn't seem to matter where the levels of LDL cholesterol started.
If you had high risk, and you got a statin drug, your risk went down, and it went down a lot, on the order of 25 to 35 percent for the things we really care about like heart attack, stroke and death.
Don't forget that cardiovascular disease is the leading cause of death in men and women in the United States and most developed countries. So it's about risk; it's not so much about the numbers anymore. The problem is we've been telling people for decades it's about the numbers, and now we're going to have to reeducate everybody, including primary care physicians, about who we think they ought to treat and who we think they shouldn't treat.
CHAKRABARTI: But I do wonder, though, there was a great motivation in hearing you doctor say you need to not just take these drugs but change your lifestyle, including exercise and what you eat, in order to get that LDL number down. And now that the number doesn't matter anymore, do you worry that the motivation that came along with that might be going away, or we might not be focusing enough on lifestyle factors, exercise, food?
NISSEN: Well, it's a great question, and let me be very clear. No pill is a substitute for a healthy lifestyle. Everybody should eat a healthy diet. We want our patients to exercise. We certainly want nobody to smoke. And if you have diabetes, we want you to have your diabetes, your blood sugar, treated.
So it is important that we not look at this as a pill to solve all problems. However, the reality is about modern American lifestyle is that too many of us are obese. About one-third of the population now in America is obese. And too many of us still smoke, perhaps about 20 percent of the population. We haven't been able to lower risk with lifestyle changes alone.
This is about what do we need to do on top of those lifestyle changes to reduce the risk of heart disease.
CHAKRABARTI: Well Dr. Nissen, in the last, you know, 40 seconds or so we have here, I do want to ask you about the fact that virtually all statins are available in generic form now, but the big brand name drugs, Lipitor, Crestor, they're still - you know, people are spending a lot of money on them, $21 billion as of 2010.
And I'm seeing that half the panel who crafted these new guidelines have financial ties to the pharma companies that make statins. But the head of the panel has said that no one with industry connections could vote on the recommendations. But in, you know, in the 15 seconds or so we have, do you have any concerns about that aspect of these new guidelines?
NISSEN: I'm okay with it. Let me just point out, by the way, that there's only one of the statins that's still branded. Lipitor went generic several years ago. We can get these drugs for most patients for as little as $10 for a three-month supply. So there isn't a profit motive anymore here, and I think that makes it a whole lot easier to accept the guidelines.
CHAKRABARTI: Dr. Steven Nissen is chairman of cardiovascular medicine at the Cleveland Clinic. Dr. Nissen, thank you so much.
NISSEN: My pleasure.
CHAKRABARTI: You're listening to HERE AND NOW. Transcript provided by NPR, Copyright NPR.