Robert Crayhon (RC): Dr. John Abramson is the author of the book Overdosed America, someone with a great deal of clinical practice who's also spent many years researching the whole cholesterol story. Dr. Abramson, welcome.

Dr. John Abramson (JA): Robert, it's a pleasure to be with you.

RC: Dr. Abramson, this is something that happens across America thousands of times per day: a 50-ish man or woman gets their cholesterol level checked at their annual exam. Their doctor discusses the results and says that their total and their LDL cholesterol levels are just a bit too high and they should eat a healthy diet and decrease their saturated fats and get their blood test redone in three months. They do that, and the levels are still high, and they're put on a drug, and told they don't have to be so careful about exercise and diet now. What do you think of this approach to preventing heart disease?

JA: Well, that's exactly right, Robert. That's how the scenario goes. I think that there are many things that are wrong with this approach. The most important thing that's wrong with it is that it doesn't address the real causes of heart disease, and if the real goal of our interactions with the medical system is to decrease our risk of heart disease, then this is a very bad way to do it.

Where to begin. First of all, there is not a single randomized control trial that shows that cholesterol-lowering statin drugs are beneficial for women of any age or men over 65 who do not already have heart disease or diabetes. It's never been shown, and the guidelines that claim to be evidence-based simply aren't evidence-based. In fact, the 2001 National Cholesterol Education Program guidelines that made recommendations – for women who didn't have heart disease, but were at moderately elevated risk, to be put on statins – admits this at the end. The guidelines say that clinical evidence for these recommendations is generally lacking, and the recommendations made for women are based on extrapolation of the data from men. Similarly, for people over age 65, there's no evidence. So, no evidence exists that it's beneficial for large groups of people.

Now, the key to the scenario that you presented, given that there's clinical evidence lacking for primary prevention for women and people over 65, is that the doctor is giving his or her patient the wrong message, because when the doctor says, "come back in three months and if your cholesterol hasn't budged, we'll put you on a statin, and you won't have to worry about your diet and exercise," that's exactly the wrong message. Diet is far more important than cholesterol level, and exercise is not only more important than cholesterol level, but being unfit is a greater risk for heart disease than the entire Framingham composite risk score. So if somebody's cholesterol level doesn't budge, to put them on a statin and say don't worry about diet and exercise is absurd based on the real scientific evidence. Doctors don't get that. I lecture all over the country, and doctors don't understand that they're making an enormous mistake when they say exactly what you laid out in the scenario, Robert.

RC: So we're talking about the #1 killer of Americans.

JA: Well, let's be careful. We're told that it's the #1 killer, and you should know your numbers, but for women, for example, who are below the age of 75, cancer takes 78% more lives than heart disease. So that #1 killer campaign is a little bit of a fear-mongering effort.

RC: Nonetheless, a major health problem, and what I was going to say is, it's being mismanaged.

JA: Right, it's being mismanaged. Let me tell you to go back to the scenario. The Lyon Diet Heart Study is probably one of the most important studies that's been done to prevent recurrent heart disease. What the study did is this: it took patients in Lyon, France who had had heart attacks and randomized them into two groups. This is the way the statin studies are done. But instead of putting one group on a statin and the other on a placebo, what the Lyon Diet Heart Study did was assign one group to receive counseling about eating a Mediterranean-style diet and the other group simply received counseling on eating a prudent post-heart attack diet. You come back about three or four years later, and you see that the group that was randomized – this was a randomized trial – the group that was randomly assigned to be counseled to eat a Mediterranean-style diet had two-and-a-half to three times less risk of recurrent heart disease and death than the group that was randomized to eat the conventional diet. Well, you say, that's very good, and obviously the diet had an effect on their cholesterol, but the key point here is that the diet had no effect on their cholesterol. The group that was assigned to eat the Mediterranean-style diet had exactly the same cholesterol level as the group that was eating the standard post-heart attack diet. So the bottom line here is that eating a Mediterranean-style diet is two-and-a-half to three times more effective than a statin in preventing recurrent cardiac events and death in people who already have heart disease, and it is not mediated by cholesterol levels whatsoever.

RC: And yet statins are being pushed constantly.

JA: They're being pushed constantly. I presented at a conference about three weeks ago, Robert, down in Florida. It was an excellent conference, and I presented for an hour about how I saw the scientific evidence. And then two local docs who were cholesterol and heart disease experts rebutted me, rebutted the position that I was presenting on the statins. It took a little while to understand what they were saying, but the doctor who was the local cholesterol expert was making this argument: he looked at my data, and he said, okay, it doesn't appear that there is evidence from clinical trials that statins are effective for women or people over 65 who don't yet have heart disease. But when we do more sophisticated studies like intravascular ultrasounds or 250-slice CAT scans of the heart, we see that almost everybody has evidence of atherosclerosis, even at a very young age, and therefore nobody's really primary-prevention, and therefore everybody should be on statins. I finally understand what I think is the pro-statin argument. But there's an enormous logical flaw in that. There's a logical dishonesty in it, because the clinical trials that have been done have defined primary-prevention patients as those who do not have a clinical history of cardiovascular disease. And what we find when we define the group of patients like that is that statins have not been shown to have a benefit for women or people over 65. So, the scientists who are claiming to rely upon evidence-based medicine somehow turn away from evidence-based medicine and go to conjecture and what they believe ought to be true rather than sticking to the results of the studies. And the vast majority of these studies have been designed by the drug companies themselves. It's not like there's some public interest group that's anti-drug that has manipulated the studies against the drug companies' interest. It's exactly the opposite.

RC: You know, all this reminds me of a Peanuts cartoon I saw years ago where Lucy's looking down at the ground and she says, "Look at this butterfly, Linus. It's so beautiful. How did it get here all the way from Brazil?" And Linus looks down and he says, "That's not a butterfly, that's a potato chip." And she looks down and goes, "Wow! How do you think this potato chip got here all the way from Brazil?" And there's this sort of slight-of-hand where the very central argument collapses but yet we're still sold the same product.
Let's go back to the diet discussion you had. One of my favorite books about the history of both the health food movement and the awareness of nutrition is called The Food Factor, which describes how, during World War II in England, people didn't have margarine, and they didn't have white sugar, white flour. They couldn't afford them. They had whole grains, and they had butter, and the heart disease rates plummeted in England. You'd think they would have learned from that, but they didn't, and after the war, slowly all these refined foods came back. We have all this data that there's a much less expensive way to treat heart disease than statins, which are expensive: the Lyon Heart Study. And then we have the World Health Organization coming out with a study showing that half the people with heart attacks have a normal cholesterol level. So there's all this false information, not just in the statin story but also even in the cholesterol level story, and we've got a natural solution, but nobody wants it. Why? Does it come down to money?

JA: The bottom line is, yes, it does. And it's not a matter of cost. It's not that the statins are too expensive a way to do it. It's that the statins aren't an effective way to do it. That's the problem. If it were just money, I would say spend your money however you want to spend your money. We're a fairly wealthy country, we can do it. That's not the problem. The problem is that people think they're spending their money wisely, and doctors think that they're practicing good medicine, and we're not getting the outcomes we want.

This is how bad it is, Robert. There was an article in the New England Journal of Medicine a couple of months ago extolling our victory over heart disease, showing that the death rate from coronary heart disease has gone down by 50% in the United States since 1980, and much of that has to do with reducing risk factors like lowering cholesterol. That's in the New England Journal of Medicine, and that's what's going to be taken as the gospel. And the study covered data from 1980 to 2000. The truth is that, in 2000, Americans were twice as likely as Europeans to be taking a statin at a given level of risk of heart disease – twice as likely to be taking a statin and three times as likely to be getting a surgical or invasive procedure to open up a blocked artery. So we're getting twice as many statins and three times as many procedures to open up blocked arteries.

Instead of being ranked as the best for coronary heart disease death rates among industrialized countries, we ranked 17th among industrialized countries. You might say we were just learning to use statins, and we were just starting to use these invasive procedures to open up arteries, so the fact that we were doing more of it means we may have ranked 17th, but we must have been getting better – except that we were getting worse results than nine out of ten industrialized countries. So we're taking twice as many statins, three times as many procedures to open up blocked arteries, and we ranked 17th, and we're losing ground to nine out of ten industrialized countries. It's nuts.

And you say, well, how can that be? And then you look at this beautiful work that the Centers for Disease Control has done, where they create maps of the United States, state by state, and the states that have a higher percentage of people with risk factors for heart disease are darker. You can see in maps from 1991, 1995, and 1999 that the United States just gets darker and darker and darker, and we're just moving in the wrong direction Why? It's Sutton's law. It's because cholesterol is where the money is. The money is not in helping American people to understand that an epidemiologically informed approach to reducing the risk of heart disease has to do with exercising and eating a healthy diet, not smoking, and controlling stress – that that's how to reduce the risk of heart disease.

The problem is, in our market-based society, where knowledge is largely generated and distributed because of its profit-generating potential, what happens is doctors discipline doctors, and intelligent public citizens are confused by what appears to be scientific evidence showing that statins are the best approach to reducing the burden of heart disease. It's almost impossible to get the truth out.

RC: One of the anomalies of all this is that you see a 350 lb. person walking down the street happy because, okay, they haven't lost weight, but they're on a statin, so all is well.

JA: Absolutely right, and we've heard about Avandia recently in the news. Avandia is a very expensive diabetes drug. It can cost up towards $200 a month to take this drug. The reason, the real primary reason why we treat diabetes, type 2 diabetes, is not so much that a high blood sugar causes its own problems, but that there are cardiovascular side effects that are devastating. So three-quarters of people with type 2 diabetes eventually die of cardiovascular disease. The reason why we treat people with diabetes is largely to prevent cardiovascular disease.

Now along comes a drug that costs upwards of $200 a month, and when you look at its manufacturer's own study, which was published in the Lancet last September, you see that the study claimed to have looked at a population of pre-diabetic patients - patients whose fasting blood sugars were between 110-125 – randomized them to get treated with Avandia or a placebo, and the article claimed that the Avandia was a good treatment, because among those taking Avandia, 60% fewer people developed diabetes, compared to those who took the placebo. But when you look at the article, you see that the people who took Avandia gained four-and-a-half pounds more than the people who took the placebo; that their risk of diabetes was not decreased by 60% -- the diagnosis was simply delayed by a year; and that the people who took Avandia developed 37% more serious heart disease than the people who took the placebo. That article was spun – that wasn't quite statistically significant – but that article was spun to doctors as evidence that they should put their pre-diabetics on Avandia, when, in fact, there was absolutely no evidence that it was beneficial to their health. In fact, the study showed that there was a 37% increase in the risk of heart disease.

Now, because the article is sponsored by the manufacturer, they get to spin the way they want to, and they make the study conclusions look like an advantage, when I think reasonable people would look at that data and, especially in conjunction with data that shows that lifestyle interventions are very effective at preventing diabetes, and say, wait a minute. We don't want to spend $7,000 on Avandia per patient over three years and increase the risk of heart disease by 37%. That's not what American medicine ought to be about. Unfortunately, Robert, that's where the profit is and that's directing what doctors believe to be true about the best way to treat their patients.

RC: Well let's look at where all the profit is. You've spoken about it. It's estimated that we spend $2 trillion dollars in America to buy the food that we don't need that makes us obese. We spend another $2 trillion taking care of the health problems caused by that overweight and obesity. And if you think about it, and it's almost too Machiavellian to believe, the failure of statins, by creating the need for more invasive procedures to rescue damaged arteries or at least postpone the ultimate death of the patient, is also another way to generate profit. So I'm not saying that there's a bunch of people sitting in a room going, "Great! We're so glad statins don't work." Clearly, it looks mostly like there's drug companies just pushing them on everyone, but the question is, what kind of a world do we live in when there are so many direct-to-consumer advertisements telling patients what products to solicit from their doctors? And I just want to add this, when you look at the bottom of these drug ads for cholesterol-lowering medications, the new drugs in particular, have fine print that says things like, "Oh, by the way, this drug does not prevent heart disease or heart disease-related deaths." Well, then, what's the point?

JA: Well, actually, that was taken off in 2004, I think. I've been looking at that issue, that disclaimer, with the ASCOT study, which looked at 10,000 people with hypertension and three other risk factors for heart disease. The study put half on Lipitor and half on a placebo, and there was around a 36% decrease in the risk of heart disease in the people on the Lipitor, and the FDA allowed the makers of Lipitor, and I believe the other statin-makers, to take that disclaimer off. The problem with that study is that, first, it was stopped prematurely when there was this statistically significant reduction in cardiovascular disease but there was not a statistically significant reduction in overall mortality, which is the key factor, the key outcome. The second problem with that study is that there were 2,000 women in that study – 2,000 women who had hypertension and three other risk factors, half on Lipitor, half on a placebo – and the women who were put on the Lipitor developed ten percent more heart attacks than the women who were put on the placebo. The FDA allowed the drug companies to change the label, especially on Lipitor, to say that Lipitor does prevent heart attacks, based on the ASCOT study, when in fact there was no evidence, and, if anything, counter-evidence existed to show a benefit for women who have high blood pressure and at least three other risk factors.

RC: Let's talk about what does prevent heart disease: exercising, quitting smoking, following something along the lines of the Mediterranean diet. Things like that?

JA: Let's talk about exercise first. When doctors are following the guidelines that are endorsed by the National Institutes of Health, they look at people who have two or more risk factors for heart disease, and then they score their risk for developing heart disease over the next ten years, their probability for developing heart disease, according to the Framingham risk score. If your risk of developing heart disease over the next ten years is between 10-20%, then the guidelines create a threshold for when you should be on a statin; if your LDL level, your bad cholesterol level is above 130, you should certainly be on a statin if you are in that 10-20% risk group, and there was a revision that suggested you should be offered a statin if your LDL is above 100. Now, exercise, physical fitness, is not even included in that composite risk score that determines what your risk of developing a heart attack is over then next ten years, and we see from studies that unfitness – being physically unfit – explains twice as much of the risk of dying over the next ten years as does the Framingham risk score. And the Framingham risk score doesn't even have exercise in it. So doctors are basically being trained not to address the exercise issue when they put people on statins.

RC: What about diet?

JA: Diet is enormously important. We talked about the Lyon Diet Heart Study. That's a randomized controlled study. We've seen other randomized studies. We've seen the Nurses' Health Study that shows that nurses who eat fish once a week have a 31% reduction in their risk of heart disease. That's exactly as effective as a statin, eating fish once a week. Now that's an observational study, but it fits in with the pattern that we're seeing in the randomized controlled trials.

So, diet and exercise are extremely important. Quitting smoking is extremely important. Now, doctors are kind of fed this line that a) they're not good at counseling, and b) nobody listens to them when they do counseling. There was a beautiful study that looked at senior citizens who were admitted to the hospital with a heart attack and simply the suggestion while they were in the hospital that they quit smoking significantly decreased their risk of dying. But treating them with a statin doesn't significantly reduce their risk of dying. So, part of the distortion of our knowledge that happens because our knowledge is fundamentally serving commercial interest – part of it is to push statins and to push profit-seeking ways to improve health, and part of it works on the other side to discredit the effectiveness of the things that people can do to reclaim responsibility for their own health. And what we know, what the real truth is, is that two-thirds of our health is determined by how we live our lives and where we live our lives. In other words, we're responsible for most of our health. Certainly, medical science has wonderful benefits to offer some people who are sick, but playing catch-up is not nearly as effective as being responsible and taking preventive action to live a healthy lifestyle. But that gets dismissed because there's not much money in it.

RC: What percentage of statin use in this country do you think is actually warranted?

JA: The best study we have is on Canada. We can assume that, in Canada, the use is, if anything, more conservative than the United States, and we see data from, I think, 1996 in Canada that shows that 74% of statin use is for primary prevention, meaning for people who do not have heart disease or diabetes. Amongst that 74%, how many are women and how many are men over 65? It's going to be a goodly percentage, so I think what we're going to see is that somewhere around 30% or 40% of statin use simply is not justified by the scientific evidence. But that said, Robert, even if we look at very high-risk men who don't have cardiovascular disease already, such as the men in the WOSCOP Study (published in the New England Journal of Medicine in 1995), if you treat those very high-risk men with a statin, you reduce the risk of developing heart disease by 31% and the risk of dying by 22%. But in real terms, that translates into the following conclusion: if you treat 50 high-risk men for five years, one of them will benefit because they were taking a statin drug. So it's not a slam-dunk, even for the highest-risk men who don't have a history of cardiovascular disease or diabetes, that taking a statin is going to benefit. In fact, there are 49 out of 50 chances that it won't benefit you. When we tell those numbers to patients, many patients suddenly are willing to listen to the idea of improving diet and adding exercise and quitting smoking because they realize that statins aren't the cure-all that they're made out to be.

RC: So what is the solution for either the practitioner, a nutritionist, or a colleague of a practitioner who's prescribing statins right and left to patients they may have in common? Or the patients getting the statins? Show them a copy of your book or summon some of the Lyon Diet Study data? How do we begin to wake up the statin dispensers?

JA: Please show them a copy of my book or show them the article that I wrote that was published in the Lancet in January 2007, showing that there's no evidence for women or people over 65 to take statins for primary prevention. But I think there's a deeper problem here, Robert, and you've been bringing it up. I think there's what we call an epistemological problem. There's a problem with the way that our knowledge is produced and disseminated, so that we think that medical knowledge is produced and disseminated in order to improve our health, and it's really been privatized as the truth. Medical knowledge is produced and disseminated in order to maximize corporations' return on investment. And I think the first step in becoming medically literate, medically competent, and medically empowered is to understand that most of the knowledge that is put forth in the medical journals, in the guidelines, in doctors' continuing education classes, when the drug reps come and bring lunch, when patients hear drug ads on TV, when they hear public service advertisements from organizations – supposedly non-profit organizations that consumers have grown to trust over the years for their independent reviews, but that are, in actuality, really taking money from the drug companies and from doctors' professional societies, which also now have grown dependent on drug company money – when we hear medical information from all of these sources that we are taught to trust and really have no alternative but to trust, we have to understand that most of the information that's coming our way is coming our way because it's commercially beneficial to the producing organizations, the corporations, for that information to come our way.

What we need to do is become intelligently self-empowered. Step one is to understand that most of preventive medicine has to do with living your life in a healthy way. Absolutely get your blood pressure checked. And I'm not against the recommendations that say get your cholesterol checked every five years. There's no organization that says get your cholesterol checked more than every five years, and yet it's become a standard part of each year going by that we get our cholesterol checked. I'm not against intelligently using medical screening, and we do need to treat blood pressure – hopefully, by non-pharmacolgical means, but sometimes with drugs. We need to use medical science, but we also need to understand ultimately that most of what goes on with our health, most of how we're going to age and die, has to do with how we live our lives now. And it's that message of empowerment that I think is so important for the public and for doctors to understand.

Transcribed by Suzanne Copp, MS

Dr. John Abramson's book is Overdosed America: The Broken Promise of American Medicine (Harper Collins, 2004). Dr. Abramson is a clinical instructor at Harvard Medical School.

Robert Crayhon, MS, CN is a nutritionist, educator, and author of four books, with 20 years of clinical experience. Free downloads of three years of his "Nutritional Medicine Update" shows are available at www.CrayhonResearch.com