I have some awesome and very passionate followers who ask great questions. I’ve had exchanges with a few about my statin and inflammation post, and I wanted to share them with everyone in an easy to follow format. Here is my original post, and three comment exchanges that I think are very educational. Each commenter made great points and I tried to explain my side the best I can. I hope everyone finds them interesting. If you have not read the original post, I hope you will now! Question or comment? Send it to me!
I tweeted a link to a study today about the use of Statin cholesterol drugs in essentially any patient over the age of 50, and how routine use in these patients significantly lowered their risk for a significant cardiovascular event (heart attack or stroke). Now before you just dismiss this as another example of how big pharma is trying to take over the world, let me tell you why you need to pay attention to this study.
First of all it’s big…like 175,000 people big. In the world of clinical studies, that’s a very impressive number. The more patients take part in a clinical trial the more powerful it is in general. This study took 175K people and showed that even in patients with a very LOW risk for heart disease, statin drugs improved their risk of events significantly. Is this surprising? Not at all!
Several years ago the so called JUPITER trial looked at the ability of statin drugs to lower what is called highly sensitive CRP (hsCRP). Studies have shown a very nice correlation between hsCRP levels and short term risk of heart attack. Levels below 1 are good, between 2-3 are moderate risk, and between 4-10 are high risk for badness. This trial took 18,000 patients with low LDL (bad cholesterol) and no cardiac risk factors and put them on statins vs. placebo. The results were so beneficial for the statin group that the study was called off early to allow the placebo group the chance to take a statin. The marker used to track benefit was a consistent drop in hsCRP in the statin group.
So what does that mean? CRP is what we call a marker of inflammation. A regular CRP measures levels of inflammation throughout the entire body, while hsCRP was developed specifically to look at inflammation in the cardiovascular system. So if we can lower the hsCRP it means that we are lowering the inflammation in the cardiovascular system (easiest way to look at it). In turn, if statins lower hsCRP, then they must have anti-inflammatory activity right?
That is absolutely right. It has always been known that statin drugs have a kind of two tiered mechanism of action. The significant improvement we see in cardiovascular risk seen in patient’s taking statins is too great to be coming only from a simple drop in the patient’s cholesterol. Statins go into the inflamed walls of diseased arteries and block inflammation. They are what we call “Plaque Stabilizers.” Heart attacks and strokes occur when an artery wall is inflamed and swollen with inflammatory markers and cholesterol. A plaque can be “stable” when it is relatively dense, or “unstable” when it is fluffy and chock full of inflammation and fat. One little irritation in the cap of an unstable plaque leads to a lighting fast inflammatory response and acute blockage of the artery with a clot. Anything downstream does not get oxygen; if its heart tissue you get a heart attack, if it’s brain you get a stroke. So statins without doubt lower your risk of heart attack by lowering your cholesterol, as well as lowering the inflammation in your arterial walls. This is essentially fact.
Another action statins have on the inflammatory cascade of heart disease is that they counteract the known inflammatory effects of Omega-6 fatty acids. In our world where the fat pendulum has swung almost completely to the Omega-6 (over Omega-3) side of the aisle, there is no surprise that statins help so much. Again, this is essentially fact.
The mistake that was made many years ago was in believing that statins purely lowered heart disease risk by lowering blood cholesterol levels. Linear thinking led to the belief that lowering dietary cholesterol and fat MUST in turn lower heart disease risk as well. Good idea, just not the right idea! Statins REALLY work through their anti-inflammatory properties to lower cardiovascular risk, but we didn’t figure that out till later! Easy mistake to make, but now that we know the rest of the story, we need to go back and correct our thinking. Unfortunately that is proving more difficult than many of us would like.
One other thing to discuss is side effects of these medicines. I am completely amazed at the generalized fear and misrepresentation of the side effects of statin drugs. They have clear and known potential risks, particularly concerning the liver and with generalized muscle weakness. That being said, I can say in my clinical experience these drugs are generally very well tolerated and safe. I have been prescribing statins for near 11 years in both training and private practice, and I know of one definitive case of rhabodomyolosis (life threatening muscle breakdown) and only a handful of cases involving significant (but fully reversible) liver inflammation from the drugs. Are statins for everyone? No. Are they the most dangerous drugs in the world that should be pulled off the market? Absolutely not. They are safe, and they work.
So, what am I saying? Does everyone need to be on a statin? Well, if we don’t change our dietary ways as a society the answer may be yes! In my humble opinion there is a better way of course! Say for example we significantly curtail wheat in our diet, as well as any other similar proteins that can cause generalized inflammation in our bodies. This should in theory lower our overall CRP levels, and likely our hsCRP levels as well. In addition, what if we concentrated on changing the fatty acid profile of our foods to shift the Omega-3:Omega-6 ratio back to the side of Omega-3s. This would be like turning back the hands of time in our food supply to a time when corn, soy, and wheat did not dominate our agriculture. We know (fact) that Omega-3 fatty acids are not atherogenic so we would easily lower our cardiovascular risks as a whole. With these two actions as a society we would accomplish the same thing as giving everyone a statin. Amazing huh?
The problem is that these changes would be very hard to bring around. It is easy for us to sit on our Paleo high-horses and state the obvious, but it will be a real battle. A fundamental change in the way we raise our protein in America and around the world will be a daunting task. Finding ways to affordably feed the world’s population without a dependence on extremely cheap wheat based products will take years of work. It is not easy, but I feel it must be done.
I hope this helps you think twice next time you see a headline about the benefits of a drug. Before you spout off some diatribe about the evils of big pharma, look closely at what it’s all about. Are statins overused?…according to this study they should be used more! And, we likely WILL use them more. That being said Statins work, they are safe, and most interestingly they teach us a great deal about inflammation, heart disease, and why our beloved Paleo lifestyle works.
I hope this all made sense to everyone. If you have any questions leave a comment or feel free to tweet me at @PaleolithicMD.
In the end…it’s ALL about inflammation!
-E
Number 1:
Steve: Great article, wasn’t fully aware of the Omega 6 issues. I am just curious which satin your prescribe because the Jupiter trial only used Crestor and because of the great findings the study was ended TWO Years early. When the Jupiter trial was presented at the ACC meeting, Crestor received a standing ovation because of the findings.
Me: In general I see a statin as a statin. But, some have better data in some areas than others. Ultimately it is almost completely about Insurance Coverage. Many insurance companies require what the call a “step-edit”, or failure of a generic statin before I could even consider Crestor. It is a good drug though, and is used often. I bet a similar study with another statin may yield similar results; probably a class effect to some extent.
Number 2:
Tami: Interesting. I think you are the only paleo advocate I’ve ever read in favor of statins. My father, my uncle (on my dad’s side), another uncle on my mom’s side, a neighbor, and a friend were all on statins and all had the horrible side effects. Extreme muscle pain, loss of memory, fatigue. My dad was also on blood thinners for 15 years and never had trouble regulating them, until he was put on a statin. After that he was unable to keep his blood at the correct levels.
Isn’t the listed percentage of people that have these side effects something like 5-10%? My question is, if statins’ side effects are so rare, why did ALL of these people in my small circle of family and friends have such severe reactions? Coincidence? Does that just mean that 90% of the other people I know that are on statins (unbeknownst to me) have no side effects but just never say anything? Also, the people I listed above are not the only people I know that have had these problems, the ones I listed are just the people I can name off right away.
I’m not trying to be argumentative, I really do want to understand. Both of my grandfathers, my dad, all four of his siblings, and three aunts and uncles on my mothers side have had heart surgery and/or heart attacks, so that is a fate I very much want to avoid. Obviously, I believe eating paleo/Whole30 style is the best thing I can do for myself, or I wouldn’t be reading your blog. Sorry for the long comment, but what you said just raised some questions I’ve had in the back of my mind for a while.
Me: No problem at all on the long comment, I really welcome the dialog here on the blog. Also, I’m sorry to hear that so many in your circle have suffered from the problems that they have. Let me explain where I am pro statin, and where I am not. I hope it can help you understand my point of view better.
If you have a known history of coronary artery disease, diabetes, significantly elevated cholesterol, or a combination of other cardiac risk factors such as a strong family history, smoking, or obesity you need to consider a statin to control your cholesterol. Or at least put it this way; in my patient’s I will give them a choice. They can either follow a VERY strict Paleo diet and we closely monitor the cholesterol for improvement, or they continue with their eating lifestyle and take a statin. It is very common for people to refuse to change their diets to the extent they need to in order to avoid cholesterol medication. It is also medical malpractice in high risk patients not to recommend they go on a statin if they will not change their numbers with diet. Regardless of what many may want to believe, the science is fairly strong that statins save lives in these individuals. I would agree with your 5% stat on common side effects such as muscle aches, but I have honestly only had one patient that I felt may have been affected by statins when it came to their memory. I am not at all saying it is not possible, but my experience and the experience of my 8 partners do not see that as a common issue. Lets say you take a 65 year old male with well controlled but treated high blood pressure, a history of diabetes and obesity who has a total cholesterol of 250, HDL of 35, LDL of 140, and Triglycerides of 160. Using a well established heart disease risk calculator his 10 year risk of having a heart attack are >30% and their calculated “heart age is >80. Take that same gentleman and aggressively lower the total cholesterol to below 160, and raise their HDL to 50, and the 10 year risk of heart attack drops to 21.6%, and his heart age drops to 72. That means in 10 years you can save one life by changing their cholesterol profile. These are real numbers, so people have a choice. I do not care how they lower their cholesterol, but they need to. The reality most choose statins over dietary change, and therefore I use them accordingly.
Many will say, wait!, you said lowering the cholesterol isn’t how statins really work! You are right, I think that the statins ability to lower risk in these patients, although certainly in part due to lowering cholesterol (particularly newer generation statins that appear to shift the overall LDL size from the more dangerous small size to the less worrisome large, fluffy size), is mainly from the anti-inflammatory action they have. I discussed in the post how the Paleo diet should lower inflammation, shift LDL particle size to larger particles, and thus lower cardiac risk as studies indicate.
The side effects are real, but death from a heart attack or stroke are more real to most of these patients. They are not going to change their diet, so any suggestion that statins go away purely on “principle” is hard for me to accept. I cannot judge my patients if they choose not to make the dietary changes I have made in my life. It is essentially down to either face a very high risk of heart attack, change your diet, or have muscle aches with the statin.
What we need is clear clinical data showing that Paleo works, and that it changes people’s cholesterol profiles in the ways we know will help reduce their cardiovascular disease. Hopefully as a community we can move those things forward in the years to come.
Again, individual cases are very real to those who experience them, and all that I can speak to is MY experience with these drugs. Although I practice and preach Paleo as much as I can, I have patients to take care of. There are many who feel changing to a Paleo lifestyle is simply impossible. Although this is my optimum choice for them, there always has to be a plan B, and for cholesterol at this point it is statins. I believe it is imperative to seek change as a physician moving people towards a new vision of nutrition in America looking more realistically at the role of fat and carbohydrates in our diets. That said, I also believe in science, and the science sometimes calls for the use of drugs to prevent disease. It is science after all that we use to defend the Paleo beliefs that we hold so dearly. I really hope this helps even a little bit with your questions. I care deeply for my patients, and I really hate that you have had these experiences.
Tami: Thank you very much for taking the time to answer my questions.
“Or at least put it this way; in my patient’s I will give them a choice. They can either follow a VERY strict Paleo diet and we closely monitor the cholesterol for improvement, or they continue with their eating lifestyle and take a statin.”
That clarifies it quite well for me. I understand completely how hard it must be for you to talk people into changing their diets. I have tried talking to family members who have health problems into just changing what they eat a little bit and they don’t want to listen at all. I guess they have to want to help themselves before they will listen to anyone or anything, even a doctor. If you would rather take a pill than work to make your life better, then I guess you get what you get.
The side effects my friends and family experienced with statins were much more severe than muscle aches. My dad had muscle pain so severe he couldn’t work (he was a cattle rancher), and started to get disoriented and confused (dementia type symptoms.) As soon as he quit statins the symptoms stopped.
My neighbor also had dementia type symptoms so severe that his family thought he was getting Alzheimer’s. He stopped the statins and the symptoms went away. I guess I have a bit of a bias against statins because I saw firsthand how they suffered, and it made me a bit angry every time I would hear of another person I knew having problems with them.
Thank you again for your time. I just found your site yesterday through Whole9, and I am enjoying it very much.
Me: I really am glad you are enjoying the site, and I again am sorry you have experienced such terrible side effects through those that you know. One particular patient comes to mind that had some dementia issues and the family was concerned it could be the statin. Quite honestly at that time I had not heard of statins causing many memory problems, but after researching it for them I found there have been some cases reported. We stopped the stain and saw minimal improvement, but the patient’s dementia progressed quite rapidly. The family actually requested an autopsy as they were given the option to do so for a dementia study at our state university. His brain ended up showing typical findings of severe Alzheimer’s dementia. So, I don’t think it was the statin. My guess is that a statin could affect a patient’s liver, cause muscle breakdown, and through that affect cognitive function. All these changes should be completely reversible if the statin is removed in time…That’s just a theory of course. Clearly your story shows statins can cause real issues. Again, I’m thankful I have not seen side effects to this degree in my patients. The debate will go on!
Tami: I re-checked on the symptoms my neighbor had and I was wrong, he didn’t have dementia symptoms, it was Parkinson’s-like symptoms. He had severe shaking and tremors, and they ceased after he stopped taking statins. For what it’s worth, I asked some family members today, and my dad and my uncle were on Lipitor. I think the aforementioned neighbor and my other uncle were also on Lipitor, but I’m not 100% sure about that.
Number 3:
John: Your opinion of the usefulness of statins in patients with known histories of CV disease, family history, obesity, or highly elevated cholesterol makes sense.
But what is your opinion of the common practice of GP’s prescribing statins to folks with only mildly elevated cholesterol that could be easily controlled with simple dietary/lifestyle changes but are never offered as an option? In my experience, that has become common practice. Many relatives and friends have been prescribed statins in a ‘knee-jerk’ fashion for only mildly elevated total cholesterol, with no distinction made between LDL/VLDL/HDL, etc.
Furthermore, if it is mainly the anti-inflammatory properties of statins that deliver the benefits, why do the great majority of docs use ONLY cholesterol numbers as their marker in making a determination- without considering CRP and other inflammation markers? There are several quality cohort studies, as I’m sure you are aware, that call into question the entire cholesterol/heart disease hypothesis altogether.
Would like your take on these issues, which cause me to believe that although statins can be beneficial in the cases you describe, it is being wildly overprescribed and for the wrong reasons to folks with no cardiac disease or family history. Thanks for your excellent site!
Me: John, thanks for writing in! First off, the fact is that most insurance companies do not routinely cover hsCRP, VAP Cholesterol, or other more specialized markers. When patients are faced with a higher cost for these tests they often balk. I’m currently paddling through these waters for a prospective study I’m working on with the Hartwig’s from Whole 9 Life on diabetes and the Paleo diet. Insurance companies just don’t want to pay…and it’s annoying to say the least 😉
I’m also not sure that physicians are necessarily having a “knee-jerk” reaction in prescribing statins…it’s a programmed reaction. The age at which we are seeing patients exhibit heart disease or strokes is going down steadily. It’s not uncommon at all to admit a 40 year old with a heart attack. In addition the American Heart Association and similar organizations continue to drop down the recommended treatment goals for cholesterol due to these changes in the epidemiology of heart disease. They are doing this due to the belief that lowering cholesterol will lower heart disease…which is of course only partly true (a small part at that). So, I do believe most doctors are prescribing statins more in a real effort to help. They are following the recommendations of the organizations that are supposed to know what they are doing. Many also likely fear potential malpractice claims if something happens to the wrong person and a lawyer wants to argue the physician wasn’t “aggressive” enough. Blame is the name of the game in America right now. I know of a physician who had a 43 year old “healthy” male (but a smoker) die of a heart attack and he was sued by the family for not more aggressively lowering his blood pressure and cholesterol. The man’s numbers were not terrible, but attempt was made to blame someone other than the smoking patient. People on the outside will never fully understand the pressure physicians feel to not get sued. This is a side of “over-prescribing” that is greatly under appreciated.
Solving this will have to be led from a higher level than primary care doctors. The paradigm will have to shift higher up to allow more physicians to feel comfortable to prescribe against the current status quo.
You also talk about “simple” diet and lifestyle changes. Don’t get me wrong, I COMPLETELY agree that these lifestyle changes are easily achievable, but most patients roll their eyes. Of patients I discuss a paleo lifestyle with, more than half essentially laugh me off and say its “impossible”. I’m sure many physicians who may want to approach things differently are just tired of getting laughed at, and just write the script. I’ll admit there are some patients even I won’t introduce Paleo to…I’d be wasting my time. I do all I can to get people to change, even follow Paleo myself, but it doesn’t always do much good.
I don’t want to come across as just defending the status quo, but I want this site to be about melding together Paleo and modern day medicine. To that end, I want everyone to better understand why physicians do what they do. Most physicians want to help their patients at all cost. They believe, and are being TAUGHT at this time that frequent prescription of statins is a means to that end. Our goal as a Paleo community has to be to push forward real science to challenge the status quo, and bring down total philosophy change from the top. This will free many physicians to approach common chronic medical conditions differently.
Statins are over prescribed, but the Paleo lifestyle is also underutilized…even by patients who know what it is and are given the chance to benefit from it. Is has to be a two way street. Doctors need to change, and patients have to be willing to listen! Hope this makes some sense. We are both on the same side, we just have to all figure out how to reach our common goals.
PaleoHikerMD 