For this month's Readers' Review: “Euphoria,” by Lily King, a novel inspired by events in the life of revolutionary anthropologist Margaret Mead.
Twice as many Americans will be eligible for cholesterol-lowering statin drugs based on new guidelines from two leading cardiovascular associations. Recommendations from the American Heart Association and the American College of Cardiology mark the biggest shift in heart disease prevention in nearly three decades. Statin use in a broader population has been controversial. Some doctors point to their great cholesterol-lowering benefits and their potential to reduce the risk of certain cancers. Others worry about exposing more patients to statins’ side effects, including an increased risk of diabetes and muscle pain. Diane and her guests discuss controversial new cholesterol treatment guidelines.
- Dr. Steven Nissen chairman of Cardiovascular Medicine at the Cleveland Clinic.
- Dr. Allen Taylor chief of cardiology for the MedStar Heart Institute at MedStar Washington Hospital Center and MedStar Georgetown University Hospital. He also formerly served on the American College of Cardiology Board of Governors.
- Dr. Donald Lloyd-Jones senior associate dean and chair of the Department of Preventive Medicine at Northwestern University Feinberg School of Medicine. He was a member of the American College of Cardiology/American Heart Association task force that produced new treatment guidelines for cholesterol.
- Dr. Sumi Sexton president of Premier Primary Care Physicians in Arlington, Virginia. She is also assistant professor of family medicine at the Georgetown University School of Medicine and an associate editor for the journal "American Family Physician."
MS. DIANE REHMThanks for joining us. I'm Diane Rehm. Heart disease is the nation's leading killer of men and women. As a result, millions of Americans take cholesterol-lowering statin drugs to stave off heart attacks. New and controversial recommendations from two of the nation's leading heart organizations mean that millions more could begin taking statin drugs. Joining me in the studio to talk about guidelines and what they could mean for patients, doctors, and drug companies, Dr. Allen Taylor of the MedStar Heart Institute here in Washington, D.C.
MS. DIANE REHMDr. Steven Nissen of the Cleveland Clinic joins us by phone from Princeton, N.J. And before we begin our conversation with our two doctors, we're joined by another, Dr. Donald Lloyd-Jones. He's chair of the Department of Preventive Medicine at Northwestern University School of Medicine. He's one of 20 experts on a committee that wrote the new cholesterol treatment guidelines. Welcome to you, Dr. Lloyd-Jones.
DR. DONALD LLOYD-JONESThank you very much. Pleasure to be with you.
REHMThank you. Tell us briefly about the guidelines, the new suggested guidelines, and why the changes.
LLOYD-JONESWell, so the guidelines were a result of really a four to five-year process in which a panel of experts was convened to really dig into the data on the effectiveness of statin and other medications in order to lower the risk for heart attacks and strokes. And so, as part of that process, we identified four groups that clearly benefit from taking statins in order to reduce risk, not just to reduce cholesterol, but in fact, importantly, to reduce risk for heart attacks and strokes.
LLOYD-JONESThose four groups turned out to be people who already have cardiovascular disease, so they've already a heart attack or a stroke, people whose LDL or bad cholesterol level is higher than 190 milligrams per deciliter, which really indicates a genetic form of high cholesterol, which puts people at quite high risk, even at younger ages. The third group is people with diabetes who are older than age 40 where we know, because diabetes travels with many other risk factors, the risks for heart attacks and strokes are high and the benefits from statin therapy are well demonstrated.
LLOYD-JONESAnd finally, a fourth group who are people who don't have any of the first three conditions, but, because of their particular profile, their combination of blood pressure, perhaps diabetes, smoking status, cholesterol levels, age, sex and race, that combination we can use to predict their risk. And if that 10-year risk is higher than 7.5 percent, we found ample data to suggest that that's a group that will achieve benefit from being on a statin medication and a group that should have minimal side effects, you know, so the net clinical benefit should be very real for those groups.
REHMSo how many fewer heart attacks would you expect from these recommendations?
LLOYD-JONESSure. So, you know, if we can implement these recommendations, we know that being on the adequate and maximally-tolerated dose of a statin medication will reduce risks for heart attacks and strokes between 20 and 30 percent. So if we can broadly implement these recommendations among those four groups that are at highest risk, we could potentially, you know, reduce the 1.2 million heart attacks that happen in this country per year by perhaps as much as 20 to 30 percent, if they were fully implemented.
REHMSo how many more people would you expect to be taking these drugs based on your recommendations?
LLOYD-JONESYeah, I think that's a great question. It has certainly attracted a lot of attention from the media with some really wildly inappropriate estimates. So in the documents, we outline that under the old guidelines that we published 12 years ago, the thresholds for treatment were set much higher, and we have a lot of new data that suggests those thresholds, you know, were inappropriately high for the current situation. So under the old guidelines, about 15 percent of adults were recommended to take a statin medication for reducing risk.
LLOYD-JONESUnder the new guidelines, about 30 percent or so of adults would be eligible for statin therapy. But here's where I think people get a little confused. A number of those patients are probably already on statins so, you know, while it sounds like a potential doubling of the eligible population and it is, many of those patients are probably already being treated. What I think is important about the new guidelines is, because we really focus on those benefit groups, we're going to be treating people much smarter and more appropriately so we will over-treat fewer people and under-treat fewer people.
REHMTell me about industry input into your recommendations.
LLOYD-JONESWell, I think it's a very important question, and our panels were put together initially by the National Heart, Lung and Blood Institute. And we were specifically vetted for relationships with industry and for any potential conflicts of interest that we might have. No one who works for industry was ever a part of the panels.
LLOYD-JONESSome of the clinicians and scientists who were part of the panels -- but I emphasize less than half of us had some sort of relationship with industry, and anybody who had a relationship had to disclose it every time we discussed anything and was not allowed to vote on our final recommendations. So we really were quite transparent about that and, I think, minimized any potential influence from industry in the process.
REHMSo I gather there were 20 experts on the committee that wrote these new guidelines?
LLOYD-JONESWell, it depends on -- in fact, I think this is another source of confusion in the media. There were four new guidelines published the other day. Only one of them was on cholesterol. The other three were just as important and aren't getting the attention they deserve, but they were about lifestyle means for reducing cardiovascular risk, ways to manage overweight and obesity and how we should appropriately understand cardiovascular risk.
LLOYD-JONESSo, you know, if you look across all those panels, there were 40-some individual experts that were engaged. And again, far fewer than half of them had any type of relationship with industry.
REHMHalf of them had any type of...
LLOYD-JONESFewer than half had any type.
REHMWell, but what you're saying is that half of those experts did have a relationship with industry.
LLOYD-JONESFewer than half had a relationship with industry. They had...
LLOYD-JONES...to disclose it, and, you know, they weren't allowed to vote on the recommendations. So I think I get it. I totally get it. You know, there's a real concern and an appropriate concern that industry shouldn't be driving our deliberations. But, you know, the kind of people that were in those rooms are not sheep. I can assure you of that.
REHMWhat is this going to mean for the industry with this kind of broad recommendation?
LLOYD-JONESWell, I think with regard to the statin recommendation, if it does result in more people receiving statins -- and let me emphasize, you know, the guidelines panels. We're not going to be mailing out prescriptions to patients to take statins. We're there to provide guidance to clinicians so that they can have more informed discussions with their patients. Patients can make a decision that they feel comfortable with.
REHMOkay. And before I let you go, I'd like to ask you about side effects of statins because I think many people are concerned about that.
LLOYD-JONESWell, they are, and, you know, I think there's been a lot of attention placed on statin side effects. We had the opportunity to review safety data on literally hundreds of thousands of patients who've taken statins in clinical trials, and we found really no excess risks for major complications, such as cancer, excess deaths, anything that, you know, would be life-altering.
LLOYD-JONESThere are very small rates of a little bit of liver inflammation, which goes right away with dose reduction or just a washout period. There are, you know, probably a significant amount of patients who may experience some muscle discomfort that usually, again, resolves either with dose reduction or change to a different statin.
LLOYD-JONESAnd there is a small but real excess risk of diabetes, but we don't create new diabetics out of whole cloth. Those are people who were well on the way to diabetes. And a recent, very good paper showed that the date of diagnosis of diabetes was moved forward about six weeks by someone being put on a statin, and it's only about one in 100 patients who might have that accelerated diagnosis of diabetes. But we probably prevent five heart attacks and strokes in those people at the same time.
REHMYou've spoken about implementing these recommended guidelines. What does that take?
LLOYD-JONESWell, I think it takes very important discussions among the clinical care community, particularly engaging our primary care colleagues. I think that it takes -- and these are specifically designed to hopefully be able to import quite directly into electronic health records so that the information that doctors and patients needs should be immediately available to them at the time of a visit so they can have an informed conversation.
LLOYD-JONESAnd then it takes, you know, I think, a good discussion about the benefits and the potential risks of taking a statin and understanding that in the context of the patient's risk for heart attack and stroke in the next 10 years and over their remaining lifespan.
REHMOne confusion I feel I might have, were I a physician, is measuring the risk of the potential for heart attack were I to prescribe statins knowing the risks that they involve. It sounds like a pretty complicated calculation.
LLOYD-JONESPretty straightforward, actually. We've provided, to date, on the website -- there's an Excel spreadsheet, and it literally takes about 20 seconds because all the numbers you need to plug in are things that you're measuring anyway to calculate the risk percentage. We are developing an interactive website, an app for people to use, and also the document details how to program this into an electronic health record.
REHMDr. Donald Lloyd-Jones, chair of the Department of Preventive Medicine at Northwestern University. He's one of 20 experts who wrote the new cholesterol treatment guidelines. Thank you, Dr. Lloyd-Jones. Short break, right back.
REHMAnd joining us now here in the studio, Dr. Allen Taylor, chief of cardiology for the MedStar Heart Institute at MedStar Washington Hospital Center and MedStar Georgetown University. On the line with us from Princeton, N.J. is Dr. Steven Nissen. He's chairman of cardiovascular medicine at the Cleveland Clinic. Dr. Nissen, what is your view of the new guidelines?
DR. STEVEN NISSENWell, first of all, I think the committee worked very hard and did come up with guidelines that are based largely on solid scientific evidence. But that doesn't mean that they won't be controversial. And I see the controversy emerging in perhaps three areas. One is we've been telling patients for decades, know your numbers. And we based our treatment on getting people to target levels for the bad cholesterol LDL. For most people, we said, get your values below 100, for some higher risk people below 70.
DR. STEVEN NISSENThese new guidelines come along, and they all of a sudden tell the medical community and patients, don't worry about the numbers anymore. Just take a fixed dose of a statin and either a moderate dose or a high dose, and then don't worry about your target level. There's a chance that that will produce some significant confusion, and we'll have a lot of explaining to do to our patients about why we suddenly have abandoned the numbers. So that's certainly one controversy.
DR. STEVEN NISSENSecond controversy is, what should the threshold for treatment be? The committee came up with a threshold of 7.5 percent. In the past, the clear threshold in the older guidelines was 20 percent. That's the 10-year risk of developing heart disease. It does add a lot of people to the roles of those who we're recommending treatment when you go from that 20 percent figure to 7.5. Is that 7.5 percent figure right, or is it not right?
DR. STEVEN NISSENAnd the final controversy is the risk calculator. Now the new risk calculator is not one we have seen before, and it has not been published. So we haven't had a chance to vet it by testing it in different populations to see how well it works. And I've certainly been getting calls from people, some in the media, who have put hypothetical patients into the new risk calculator and gotten some fairly odd results. And so there may be some controversy around whether an unpublished risk calculator was the right way to go in these new guidelines.
REHMWe actually spoke with a doctor at Brigham and Women's Hospital in Boston who said to us that the prediction model does not match the actual population.
NISSENI think there will be some significant criticism of the risk equations. The bigger concern is whether the risk calculator actually overestimates risk. Now, what they were trying to do is make a gender and race specific risk calculator. But I think it might have been preferable to have tested that more thoroughly before using it in these new guidelines.
NISSENAnd so the criticisms I think, you know, are valid. That doesn't mean the guidelines are not solid. And it certainly doesn't mean that we're wrong in saying we ought to be treating more patients. But where we draw the line and how we get there is an area that will require some additional thought.
REHMAll right. And now turning to you, Dr. Nissen, (sic) what do you think of these -- I'm sorry, Dr. Taylor, what do you think of these new issues regarding LDL and statins?
DR. ALLEN TAYLORWell, the guidelines really aren't that much different than the prior ones, if you look at really who we're treating. We're treating patients at the greatest risk, those with known heart disease, those with extreme levels of cholesterol elevation and diabetics. And that's not a change. And the change really exists, as Dr. Nissen pointed out, in this idea that we're potentially broadening the numbers of patients eligible for treatment. But that's something which was already coming and physicians have already been doing. It's this idea of lowering the threshold for risk.
DR. ALLEN TAYLORSome of the things that the new risk calculator's done -- and I agree with Steve's comments to large extent -- is that it not just lowers the threshold, but includes stroke as an endpoint. And patients fear stroke. And that's something which statins do prevent. So including stroke is very rational. It includes broader ranges of ethnic minorities that, in the prior risk calculators -- I mean, risk calculators are not a new concept here.
DR. ALLEN TAYLORRisk calculators were used in the old guidelines. It broadens out the ethnic minorities which were not well represented and actually were poorly represented in the prior risk calculators. So we've always used a risk calculator. This attempts to make a risk calculator better, but it will be and already is an imperfect tool. So the risk calculator is, I think, the biggest change perhaps.
DR. ALLEN TAYLORAnd then it's getting rid of, as Dr. Nissen said, this idea of knowing numbers and treating to targets. And that's a rational decision if you look at the way the trials that inform this guideline have been conducted. It is -- you have a certain criteria, and, based on that, you get a drug. And you get a drug at a certain dose. It's the drug or the dose that's been shown to work, not the efficacy for cholesterol reduction that you achieve. So it's a very rational guidelines based on trials.
REHMInteresting that you call it a very rational recommendation. This morning in the New York Times, John Abramson and Rita Redberg -- she is the editor and chief of the JAMA, the Journal of the American Medical Association -- wrote, this announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it's a consequence of simply expanding the definition of who should take the drugs, a decision that will benefit the pharmaceutical industry more than anyone else. How do you respond to that, Dr. Taylor?
TAYLORYeah, I'm interested in what Steve thinks about this, too. Maybe -- you know, there's 12 percent of Americans believe in Bigfoot. And I'll tell you that you can get -- many people have different beliefs on this, but that -- those comments express, I think, a very minority opinion. If you ask practicing clinicians, they believe in the benefits of statins. They're well evidenced by good clinical trials.
TAYLORThey do offer meaningful protection from heart disease. They have substantially powerful efficacy in terms of the treatment effects, in terms of preventing events. They are relatively free -- they're some of our safest medicines we have of adverse effects, so much so that -- as you know, there's been comments that these should be over the counter, these cholesterol medicines, these statins.
REHMDo you believe they should be over the counter?
TAYLORA separate discussion, but I think that they're safe -- they rival the safety of Tylenol, for example. And I don't hear people saying that we should take Tylenol off the CVS store counters.
TAYLORAnd lastly -- yeah...
TAYLORAnd then lastly, they do point out in that editorial -- in that op-ed that the idea that we shouldn't give away nondrug mechanisms, idea of lifestyle changes. And the guidelines are very clear that lifestyle mechanisms remain primary, right along with drug treatment. So I think that their position I would regard as a minority of opinion in this question.
REHMNow, this is interesting, Dr. Nissen. John Abramson who is a lecturer at Harvard Medical School, he's the author of "Overdosed America: The Broken Promise of American Medicine." And, as I said, we also have the cardiologist Rita Redberg who is the editor of JAMA internal medicine. They go on to say statins are effective with people -- for people with known heart disease.
REHMBut for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only failed to reduce the risk of death but also fail even to reduce the risk of serious illness. The article written by one of us shows on the same date the new guidelines rely on 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke without any overall reduction in death or serious illness. How do you see that, Dr. Nissen?
NISSENWell, let me weigh in here. And first of all -- and I think it's very important that your listeners understand this -- there are lots of people that have written popular books. Writing a book does not make you an expert. And, you know, I don't agree with a lot of Dr. Abramson's views.
REHMHow about Rita Redberg?
NISSENDr. Redberg is a very thoughtful person whom I know very well. However, I do disagree with her about this. And let me make something absolutely clear. This -- the pharmaceutical industry is not going to be enriched by these guidelines.
NISSENAnd let me...
REHMI don't understand that.
NISSENLet me tell you why. All but one of the statin drugs are now generically available. And, in fact, they're made by multiple companies around the world. You can go to a large pharmacy in a big box store. And one of the most commonly used statins is available, a three-month supply for $10 -- $4 a month or $10 for a three-month supply. So this is not about pharmaceutical industry profits. Now, look, everybody knows that I have been critical at times of the pharmaceutical industry, but we should not throw the baby out with the bathwater.
NISSENWe have a class of drugs that has been responsible for a major reduction in death, stroke and heart attack. These drugs work in a wide variety of patients. They have been tested in hundreds of thousands of patients in clinical trials, and they work. I am willing to argue the point about where you draw the line. Where should the threshold be between those people we treat and those people we don't treat?
NISSENBut whether or not the drugs are actually effective in people that have not yet developed heart disease, there is no scientific controversy whatsoever. It's only a question of where you draw the line. Now, let me ask you this. Let's say it takes 100 people on these drugs to prevent one heart attack or stroke. It makes a lot of different if you're the one person who has the heart attack or the stroke.
NISSENAnd so if you talk to a patient who's had a stroke, they will tell you their life is not often ever the same again. And so I am unwilling here to say we shouldn't treat those people because we have to treat a fair number of people to prevent one event. It is wrong thinking. I don't agree, but I do agree that we need to look closely at these guidelines and make certain they're exactly right.
NISSENOne more point.
REHMExcuse me one second here, just to remind you are listening to "The Diane Rehm Show." Go right ahead, Dr. Nissen.
NISSENMy final point is that these are guidelines, not mandates. Good medicine requires physicians to have a conversation with their patients. Talk to them about the benefits and (word?) therapies. Lay it out for them and make the decision together.
NISSENSometimes we make a decision that we will try lifestyle modifications first. And in certain people, that's not the wrong decision. And some people are reluctant to take medications. We understand that, and we work with them to try to make the best decision for them. So we're not telling everybody to be treated, yeah.
REHMAll right. And I want to interrupt you there because joining us from her office in Arlington, Va. is Dr. Sumi Sexton. She's president of Premier Primary Care Physicians in Arlington, Va. Thanks for joining us, Dr. Sexton.
DR. SUMI SEXTONHi.
REHMWill you tell me how you think these guidelines might affect your general practice?
SEXTONSure. In some ways it could be a little bit easier, and, as it was mentioned already, there's a lot of similarities to the prior guidelines in terms of treating high-risk individuals, really high LDLs, diabetics and patients who already have heart disease. But my concern is in those patients who we'll be using the risk calculator for. First, it's going to increase -- potentially increase the number of patients that I'll be treating with statins. But also I'm concerned mainly about the time that it will take.
SEXTONI understand it's a quick calculator and apps will soon be developed and it may be integrated with EMR systems. But there are so many things I need to counsel my patients about on a daily basis. So if I'm increasing by 50 percent the amount of patients that I now need to speak further about this, it's going to take more time. And, of course, it's very, very important. My primary goal is to reduce heart attack and stroke.
SEXTONBut at the same time, it's going to require a lot of discussion on the pros and cons of statins. I have a very highly educated patient population who's frequently reading. And they are in that minority who do question pharmaceutical companies. So I need to take the time to really go through that with them and discuss if this is really the right medication for them and go over all of the side effects.
REHMWhen you talk about the pros and cons, Dr. Sexton, what do you mean specifically?
SEXTONI mean, of course, the big pros are cardiovascular -- you know, preventing big events. That's the big things.
SEXTONBut in my practice, I've actually already started using global risk calculators, but I've used it primarily -- and of course we've mentioned the -- a difference in the percent -- I've been targeting 20 percent risk of heart disease or heart attack or stroke. But now the number's lower. But previously when I used that...
REHMTo 7.5 percent.
SEXTON...to 7.5 which is a huge difference. But previously when I used that, I used that to show the patient, hey, look, if you don't lose weight, if you don't exercise, if we don't make some major dietary changes here, I'm going to put you on more drugs. Is that what you really want? And that -- you know, as even the new guidelines state, the number one priority is lifestyle changes for sure. But I think with the time constraints that doctors are already facing, it's just going to be that much easier to write a prescription.
REHMSo you are primarily concerned about using this risk calculator and convincing your patients who may be in that 7.5 percent range that they need statins. I wonder, Dr. Sexton, can you stay on with us? We've got to take a short break here.
REHMThank you. And when we come back, we'll take calls, emails. I look forward to speaking with you.
REHMAnd welcome back. We have a number of callers on the line, many, many emails. First, from Robin, in Dallas: "What is the percentage of patients who suffer heart attack or stroke who are already on statins?" Dr. Nissen?
NISSENWell, statins in the populations who benefit lower the risk by anywhere from around 20 to 35 percent. That means that we're failing to protect the other two-thirds of patients. And so there are many people that do have heart attacks or strokes while on statins. Unfortunately, they didn't get the benefits that we'd hoped from the drug. We're focusing now on the group that does get the benefit, but we need new therapies, more therapies to target lowering the risk in those people that have not benefitted from statins.
TAYLORI totally agree. It's a multi-faceted problem. It's not just cholesterol. It's blood pressure. It's your body weight. It's diabetes.
TAYLORAnd so to pay attention to one risk factor, you have to pay attention to them all. But statins are the single most effective drug and probably the safest drug we have to lower heart disease risk. And don't forget that heart disease kills more Americans than any other single disease.
REHMAnd here's another question, Dr. Sexton, "Aren't we too willing in this country to medicate?" This from Sharon in Michigan. "Wouldn't a good exercise plan do as much or more without any risk of side effects or cost, to reduce people's risk of heart attacks? How were the producers of statins involved in the studies? Did this study begin about the same time the patent for Lipitor expired?"
SEXTONOkay. Well, I'm assuming that question is directed toward me. I can't answer all of those questions, but I will say I do feel we are quick to medicate. I'm not talking about just statins. I'm talking about antibiotics. I'm talking about everything. And one of the reasons is, you know, it's a fast-paced society. I see patients every 15 minutes.
SEXTONAnd there's more incentive for me to quickly see a patient and write prescription than spend the time counseling and working on a great exercise plan. An exercise plan and diet plan is awesome. That's critical, critical to caring for patients. And I try to integrate that regularly into my practice.
SEXTONSometimes is that enough for patients? No. Absolutely there are going to be high-risk patients that need to be on statin drugs because I don't want them to have a heart attack or stroke. But I also think that across healthcare we need to look at what the incentives are and how we can actually spend the time on overall risk reduction, not just using medications.
REHMAll right. Let's go to Ken, in King George, Va. You're on the air.
KENHi. I think you mentioned one of the things this measurement of the number of people that needed to be treated before you see a result. And I think the doctor said that at least 100 people needed to be treated before one person is saved. In addition to that, in this one clinical study they said 136 people needed to be treated, two people would get a heart attack and it would only save one of them. Now, your doctor that was on there just mentioned that. So that's covered. And she mentioned a number of good things that it is too easy for the doctors to prescribe this and it's a shame.
KENBut my other question is how much money is our country spending on statins and how many people are getting saved? I heard an estimate that it's several hundred million dollars per person. And it sounds like we're spending a lot of money on a medicine that isn't very effective.
REHMAll right, sir. Thanks for your call. Dr. Nissen?
NISSENWell, those figures are not right. And, again, I want to reemphasize that one of the advantages we have now that we didn't have with the last set of guidelines, is that we have drugs that are largely generic. These are very inexpensive drugs. It does not cost, you know, millions of dollars to save one life. We have driven down the risk of heart attack and stroke dramatically over the last 25 years.
NISSENMany of us believe that statins have played a key role in that reduction and risk. They were expensive previously. They're not expensive now. The cost is not the issue here. The question is making sure that benefits exceed risks. And the clear thing we need to do with our patients is explain the risks, explain the benefits and let them make an educated decision about whether the choice to take statins is right for them.
REHMAll right. And here's an email from Rick, who said, "Would you please ask your guests to cite one single study that indicates the efficacy of statins in primary prevention? Just one study." Dr. Taylor?
TAYLORSure. AFCAPS/TexCAPS, goes back 20 years. Individuals with pretty much average cholesterol who received a now-generic drug and had substantial, you know, over 30 percent reductions in cardiovascular event risk. So I agree with Dr. Nissen. The drugs are effective, and, furthermore, they're cost effective.
TAYLORThe panel writing the guideline set the threshold of risk, 7.5 percent, at a level at which there is cost effectiveness, that is there's enough events prevented to make it worthwhile to treat those patients. That's a carefully selected number, not picked out of the air. Lower-risk patients are not recommended for treatment because there the benefits don't necessarily outweigh the risks.
REHMBut that's where Dr. Sexton comes in, in terms of trying to calculate whether her patient is at lower or higher risk.
SEXTONSure. And at the risk of providing an opposing opinion here, in terms of cost, I am a big fan of generic drugs and I appreciate that many of the statins are generic right now. But I don't think we can overlook that there might be some new statin drugs coming up, less side-effect profiles, other things, new creating things.
SEXTONI mean, of course, I don't want my patients to have heart attacks or strokes, but, in the end, we've also brought to the light an important thing. But we're creating a pathway for more drugs, to be honest. So right now it's cost effective. But if you are short on time and you're carelessly providing prescriptions, that's not exactly the best route to go either.
REHMDr. Taylor, I'm sure you understand, as a practicing physician, the brief amount of time you have with patients. How will you make these calculations?
TAYLORYeah, the calculators are not new. And there is time involved in doing it. You know, we are already doing it with simple risk factor counting. That is you're over 40, you have two risk factors, but the difference now is the thresholds for initiating treatment are gone. And so I think moving forward, one of the feedback to the guideline panel could be to find other ways to simplistically identify patients, so the patients know themselves they benefit. It's very difficult for a patient to reach into these risk calculators and know that they benefit, whereas in the past guidelines they were far simpler.
TAYLORSo I think that that's maybe a refinement we could look for because the risk calculators -- they've been out there. And I'll be honest. They're not widely used. And that's a fear here, that they won't be widely used. And if that's the tool to identify who benefits, we have a problem.
REHMAll right. Let's go to the Rob in Ann Arbor, Mich. Rob, you're on the air.
ROBYes. There was one doctor earlier who was talking about that people who are skeptical of the efficacy of these drugs are compared to people who believe in Bigfoot, which I thought was extremely patronizing. And then he never has used -- and none of the doctors that are supportive of this, have used anything other than adjectives to describe effectiveness of these drugs.
ROBThey've said they're dramatic and substantial, and then the only percentage that you really could find is when he said one in a hundred, which is 10 percent, which is less than placebo. And no one's talking about nutrition other than the doctor from Washington, D.C., the woman doctor. So I want to know why the push is on, let's get more people on these drugs, when the only thing they've described is adjectives, as to their effectiveness.
TAYLORSo the point is, is that these are the most effective and well-studied class of medicines we have in cardiovascular medicine. And so if there's anything you can believe it, it's this. Now, you may choose not to believe in it, and that's fine, but realize you're throwing out decades of evidence from well-conducted studies. And that to me, I think, is difficult to do, at least for me.
TAYLORI would say that the efficiency of treatment -- this number of 1 in a 100 that keeps coming up, is solely based on the risk of a patient. And that number, that efficiency number, could be as low as 20 or 30. One in 20 or 30 patients are prevented from having an event, if their risk is substantially high. It all depends on the initial risk of the patient. And so you really can't pick one number, one in 100.
REHMDr. Nissen, do you want to add?
NISSENI do. The best study we have is known as the Cholesterol Treatment Trialists' Collaboration, published in The Lancet, a very prestigious journal, that took a look at all of the studies of statins, involving 190,000 patients. And what you see, if you read that article, is anywhere from a 20 to a 35 percent reduction in the risk of heart attack, stroke, and death.
NISSENThis is not an abstract. It's not an adjective. It's a real number. We know that these drugs do work. I understand all of the skepticism from the public and the concerns about influence of pharmaceutical industry, but we must not throw the baby out with the bath water. For those of us that treat patients with heart attacks and strokes, these are devastating events. We're not preventing a skin irritation here. We're preventing the leading cause of death in developed countries. And we have to understand the importance of preventing this disease.
REHMAll right. Dr. Sexton, do you want to weigh in?
SEXTONYes. I completely agree with what was just said, but I also think what at least my patients I know would want is more money diverted towards other ways, rather than -- of course, primary prevention we've already discussed, instead of secondary prevention, what other things, besides pharmaceuticals, can we do effectively? And what resources can we put toward both patients benefitting and their physicians benefitting in treating those, whether it's more time…
REHMHere's an email from Peter in New York, who says, "I had my first heart attack 18 years ago. I had high cholesterol. My parents died from heart disease. I've been taking Lipitor ever since. I modified my diet, quit smoking, exercise regularly. My HDL and LDL levels are well within desired range. I've had four more heart attacks since. Perhaps a better diet and exercise at an early age will have a greater impact. A pill won't fix 50-plus years of bad behavior." And you're listening to "The Diane Rehm Show." Would you agree, Dr. Taylor?
TAYLORYeah, the drugs are effective, but they don't mitigate all risks. And a perfect lifestyle doesn't mitigate all risks. There are many factors that aren't even known yet that contribute to heart disease. And that's the discovery phase. These guidelines discuss very narrowly the trial evidence supporting broader treatment with these very, very effective drugs. I would say these guidelines, in fact -- to tack onto what Dr. Nissen was saying -- actually make it harder for new drugs to emerge into guidelines. For instance, this idea of not treating to targets, makes it harder to add on existing drugs…
TAYLOR…in an evidence based way. And new drugs are going to have to have a high bar of evidence to come into the clinical marketplace.
REHMLet's go to Joe in Washington, D.C. You're on the air.
JOEYes. Hello. I'm concerned in this discussion that very recent research between 2009 and 2012 that I've been reading about revealed that statins are correlated with problems with both diabetes and the brain. Cholesterol in the brain is very beneficial element in terms of allowing serotonin flow and that kind of thing. In terms of diabetes, there was an American Medical Association study in the Archives of Internal Medicine 2012, showing 48 percent increased risk of diabetes among women taking statin medications. Thereafter…
REHMYou're going to have to be very quick, Joe.
JOEOkay. I'll be real quick. (unintelligible) has also found that the drops in cholesterol in the brain cause possible increased tendency towards Alzheimer's.
REHMAll right. I'll stop you right there. Dr. Sexton, can you comment?
SEXTONSure. Of course, we have to discuss the risks and benefits, but the thing with the diabetes is that, unfortunately, many of the patients that have high cholesterol and high blood pressure are also on the pathway for diabetes. So it's hard to discern, did the statin really do it? Did it just present itself earlier? Or, you know, all of these people need reductions, I mean, they need to have lifestyle reductions to prevent that. So I can't say it's just the statin drug.
REHMWhat about possible connection to Alzheimer's and dementia?
SEXTONSure. And I would defer to the cardiologist in terms of all the studies on that, but to me it's more important about how a patient is feeling and their actual lifestyle in terms of their quality of life. So if somebody tells me I've been on this drug and I feel horrible and I'm having trouble thinking and whatnot, then I say let's stop it for a month. Let's see how you're doing. Of course, we look at all their risk factors. And then we stop and see if things improve because quality of life is important.
REHMAll right. Dr. Taylor?
TAYLORI think it's been difficult through the studies to actually define if there's really a risk for cognitive decline. It's been carefully looked at. In fact, trials have been conducted to think that statins would actually prevent cognitive decline. Those studies simply showed no effect. So I think that there's no effect. And if actually, the reductions in stroke could be -- from stroke as another cause for dementia could be beneficial.
REHMAll right. I'm afraid we're going to have to leave it at that. Dr. Allen Taylor, he's chief of cardiology for the MedStar Heart Institute at the Washington Hospital Center and Georgetown University Hospital. Dr. Steven Nissen is chair of cardiovascular medicine at the Cleveland Clinic. And Dr. Sumi Sexton is president of Premier Primary Care Physicians in Arlington, Va. I'm sure this discussion on statins is going to continue. I thank you all for being with us. And thanks to our audience for listening and participating. I'm Diane Rehm.
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