A cash cow based on bad science

There has been no more profitable class of drugs than the cholesterol-lowering statins. Their success is based on a very simple premise: High cholesterol levels mean certain cardiovascular death. While there has always been questioning of the cholesterol story at the fringes of academic research (1), now the cries are rising within the highest reaches of the academic research community that something is just not right.

Since no one wants to die, you would think that measurement of mortality would be the primary clinical end-point for any clinical trial of a statin drug. There is no question that for people who have already had a heart attack, taking a statin prolongs their life by reducing all-cause mortality. But what about the people who have never had a heart attack but have high cholesterol levels? There the answer is much more open.

One recent article has studied all the published studies with some 65,000 patients who had high cholesterol but no evidence of heart disease to see the effect that statin drugs have on their mortality (2). The answer was virtually none. In fact, in all the statin trials published since 2005, there has been a striking lack of benefits in populations that simply had high cholesterol levels but no evidence of any cardiovascular disease (3). This is true except for one trial that was funded by a drug company that makes a new powerful, statin and run by the individual who has the patent for measuring C-reactive protein as a marker for cardiovascular risk (3).

Here was a new premise: People who had normal levels of cholesterol and no heart disease but high levels of C-reactive protein also need even more powerful statins. The fact that C-reactive protein is an unreliable marker in cardiovascular patients because it changes so quickly was conveniently ignored (4). Nonetheless a successful trial would generate more sales for the drug company and more testing of C-reactive protein for everyone going to see a physician.

So when a careful analysis of this “highly-successful” trial was published this year, it was found that there were no benefits in reducing cardiovascular mortality between the active and placebo groups (3). As the cholesterol story appears to have a growing number of flaws in it, I predict it will become more commonplace to have drug companies and medical researchers continue to use sleight-of-hand statistical dodges to make it appear their “wonder” drugs are actually doing wonderful things, like reducing death from heart disease in those who have no evidence of heart disease.

Maybe it’s time to return to a better working hypothesis of what really drives heart disease—inflammation and to use anti-inflammatory diets to prevent the occurrence of cardiovascular disease (5,6).

References

1. Ravnshov U. The Cholesterol Myths. New Trends Publishing. Warsaw, IN (2002)
2. Ray KK, Seshasai SRK, Erqou, S, Sever P, Jukema JW, Ford I, and Sattar N. “Statins and all-cause mortality in high-risk primary prevention.” Arch Intern Med 170: 1-024-1031 (2010)
3. De Lorgeril M, Salen P, Abramson J, Dodin S, Hamazaki T, Kotucki W, Okuyama H, Pavy B, and Rabaeus M. “Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy.” Arch Intern Med 170 1032-1036 (2010)
4. Bogaty P, Brophy JM, Boyer L, Simard S, Joseph L, Bertrand F, and Dagenais GR. “Fluctuating inflammatory markers in patients with stable ischemic heart disease. Arch Intern Med 165: 221-226 (2005)

5. Sears B. “The Zone.” Regan Books. New York, NY (1995)
6. Sears B. “The Anti-Inflammation Zone.” Regan Books. New York, NY (2005)

Nothing contained in this blog is intend to be instructional for medial diagnosis or treatment. If you have a medical concern or issue, please consult your personal physician immediately.

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About Dr. Barry Sears

Dr. Barry Sears is a leading authority on the impact of the diet on hormonal response, genetic expression, and inflammation. A former research scientist at the Boston University School of Medicine and the Massachusetts Institute of Technology, Dr. Sears has dedicated his research efforts over the past 30 years to the study of lipids. He has published more than 30 scientific articles and holds 13 U.S. patents in the areas of intravenous drug delivery systems and hormonal regulation for the treatment of cardiovascular disease. He has also written 13 books, including the New York Times #1 best-seller "The Zone". These books have sold more than 5 million copies in the U.S. and have been translated into 22 different languages.

40 thoughts on “A cash cow based on bad science

  1. I agree that we doctors have to manage the metabolic diseases with the concept of silent inflammation which you’ve introduced in your book of “The Anti-Inflammation Zone” yet.

  2. Honestly, I don’t think the average American has a realistic shot at living a healthy, active life unless they are blessed with a tremendous set of genes. It’s amazing how much public information portrayed as good science just plain isn’t.

    Thanks for all you do Dr. Sears.

    • Good genes are a gift, but the knowledge how change the expression of bad ones (like the ones I have for early cardiovascular mortality) is priceless. Unfortunately, it takes time to change that expression with diet. With everyone looking for a quick fix, drugs become an easy out. Unfortunately, the data often doesn’t support the hope. This is definitely the case with statins for people with no sign of existing cardiovascular disease.

  3. Hello Dr Sears,

    My question is that of what will be our needed ability to decipher fraudulent claims of research vs legitimate claims with solid evidence?

    So that we can recognize, sleight of the hand statistical dodginess practiced by the unscrupulous.

    • It is not easy. The best way is to understand the absolute differences between the active and placebo group, not the relative risk ratio. This is often found in the Need To Treat (NTT) data. This is the number of people of needed to be treated with a drug to get a positive outcome. You would be shocked by the high numbers of NTT for most drugs. This is because drugs have side-effects. On the other hand, food has no side-effects. This means the NTT is much lower if they are compliant with a diet.

  4. I am cardiology PA-C / I have high LDL numbers averaging 160 to 175 other lipids great .
    My day to day job functions allows me to see people having cardiac events in individuals with either high lipids or normal levels. I have myself been influenced by info that I read in articles and journals , and by my job ( seeing people having mi’s /stents and bypass)- to the point where I wanted to put myself on a statin ! I have nother risks other than a elevated LDL – fit and eat healthy . sometimes it’s hard to make a decision about this ?
    do I or don’t I start a statin – still not sure how I plan to play this one?

    • For a start look, at the TG/HDL ratio. If if less than 1, then the LDL particles you have are non-atherogenic fluffy LDL particles. Following the anti inflammatory diet will reduce the TG/HDL ratio. If you need further reinforcement check out your AA/EPA ratio in the isolated plasma phospholipids. If if it between 1.5 and 3, then your risk for a myocardial event is very low. Taking adequate levels of fish oil will make it easy to obtain that ratio. Finally check out your levels of oxidized LDL particles. These are vastly more predicative than LDL cholesterol levels. The best way to lower oxidized LDL is to consume large amounts of polyphenols. This means consuming a lot of vegetables and fruits.

  5. While we’re on the subject of “something is just not right”, what’s up with cholesterol lowering drugs that advise you not to take fish oil with the drug? My mother-in-law told me last week that she was going to start taking fish oil but had to stop the drug in order to do it. Also, last month, my mother told me that she couldn’t eat grapefruit with some medication, and it turns out that grapefruit was a natural remedy for her ailment.

    • The data is very clear that taking fish oil improves the cardiovascular benefits of statins. This was demonstrated in the JELIS study with some 18,000 Japanese patients who were all taking statins. To these subjects, half were given high dose fish oil and the other half given olive oil. At the end of 3 1/2 years those on the statins and fish oils had 20% fewer cardiovascular events that those did not have the supplemental fish oil. The fish oil was synergistic with the statins. I am sure that the drug reps didn’t mention this to mother-in-law’s physician.

  6. As a cardiologist in practise for close to 30 years, I have seen firsthand the evolution of statin therapy and management of cholesterol levels. I remember when the medical community would tell you that a cholesterol of 300 was normal. Things have changed. I would like to think for the better. But it is so easy for a physician to start a statin based only on cholesterol levels without looking at the entire picture. It is not as simple as giving a drug based on a blood test. Nor should it be. I wish more patients were savvy enough and motivated enough to follow the simple principles of The Zone, as I do.

  7. I am a 58 year old male, 6’2″ large frame.

    Triglycerides from a recent blood test = 121, HDL 37, and LDL 85. I am on simvastatin 20 mg and 2000 mg Omega 3 fish oil. My tri’s have come down quite a bit over the past couple years due to fish oil (I think). I have just started to use the Zone diet (about 1.5 months) and have started to lose weight, down to 241 from 252. I am also on lasix – 20 mg, glyburide – 3 mg for mild type 2 diabetes, and bystolic – 10 mg for hyper tension.
    I have set a goal to lose 30 -35 pounds and get into a regular exercise routine with the objective of getting off all med’s by end of the year. My question is this: is my goal for this year realistic, can I affect my profile enough to get off all of these medications?

    • If you can lose 30-35 pounds of fat, this will make a remarkable change in your blood parameters. However, fat loss is a slow process. You can anticipate to lose about 1 pound of fat per week on the anti inflammatory diet. In an ideal world, you could be off your medications after the loss of this excess body fat. A more realistic outcome would be a dramatic reduction in the amount of medications that you are currently taking.

  8. I have not had much success with taking fish oil to help lower cholesterol levels, even with the Zone fish oil; however I seem to have had much success with krill oil. Can you give some insight into this?
    Thanks for this blog. Great information.

    • Omega-3 fatty acids will have little effect on cholesterol levels. However, the LDL particles usually become larger and thus less atherogenic. The benefits of the krill may not be due to the omega-3 fatty acids as it much lower than OmegaRx, however it does contain the carotenoid known as astaxanthin that also can act as a weak anti-oxidant. I could not find any research literature on the cholesterol-lowering effects of astaxanthin.

  9. Drug companies need money, and are willing to stretch the stats beyond credibility. Think about it, if you could make a drug for fifty cents and sell it to a wholesaler for fifty dollars and deliver it to an end user for one hundred bucks, well, that’s like having a license to print money.

    My wife works in a nursing facility, and sees residents who take as many as twenty different drugs a day. Their poor livers have to be exhausted. I am aware of one instance where a cranky resident refused to take any more drugs.

    Guess what? He got to feeling much better!

  10. Thanks for bringing this to light. After five months on statins my 77 year old mother needed a pacemaker because her heart suddenly and without warning stopped three times. We also saw a decline in her cognitive function. I had previously told her doctor I saw no need for statins because she has had high cholesterol her entire life but her triglycerides are in the 70′s (a more important indicator of heart attack risk for women) and she has never had a heart attack or health problem. Aside from dementia she was in perfect health. The doctor continued to insist she be on statins and her husband relented. While she was in the hospital I suggested to the cardiologist that he report this as a potential adverse reaction and was told that the statins had nothing to do with it. I persisted and told him that the UCSD Statin Study Group headed by Beatrice Golomb, M.D., PhD, has reported that no studies have demonstrated that statins confer benefits exceeding risk in the elderly, and that impaired cognitive function and heart arrhythmias have been associated with statins lowering of cholesterol. The cardiologist was brusk and it seemed clear he had no intention of following up on the research I directed him to or reporting this adverse event. I have listed the UCSD website above for those interested in reading further or reporting adverse outcomes.

    • It is obvious that you had done your homework on statins and the physician had not done his. I would suggest this would be a good time to seek another physician. That’s what you would do if an such response from a lawyer or an accountant.

  11. I heard that the cholesterol level of 200 was derived by a group that had 2 factions, one wanted a level of 250, the other 150, and they couldn’t agree, so they met in the middle at 200. Is this true? What is the actual science behind the level of 200? Or is there any science?

  12. Has anyone looked into Red Yeast rice? It is a natural statin and reduces LDLs and increases HDLs. It works with well with Fish Oil.

  13. All cholesterol standards are relatively arbitrary. High cholesterol used to be 300 mg/dl. 200 mg/dl is another round number that is easily communicated. Unfortunately the Framingham study has indicated that after age 47, cholesterol levels are no longer related to mortality from heart disease. In reality it is not cholesterol that is dangerous, but oxidized cholesterol that is problem. This has been known since the 1970s. Unfortunately, it is hard to test for oxidized cholesterol and it makes a more difficult story to communicate. The cholesterol story has always been a weak one that is growing weaker by each year. Once the patents expire on statins, I think you will see a lot more adverse comments coming out about the real role of cholesterol in heart disease, which a disease of cellular inflammation.

  14. I’m an Orthopedic Surgeon and it amazes me the amount of patients I see that are on statins and OTC fish oils. I give them my spiel on Zone Fish Oils and Thorne Red Yeast Rice as often as possible. Dr. Sears, are you working on a Zone Red Yeast Rice concoction with CoQ10?
    Also, I’m due for some blood tests this year, 48 y/o-no meds save low dose ASA, fish oils, and the rice- and wanted to measure my own isolated plasma phosholipids, and oxidized LDL particles, along with the other standards. How do I tell the lab that I want to test for these #’s? Small town hospital BTW. Keep up the great work!!

    Brian

      • Dr Sears, How would I go about contacting the CLIA diagnostic laboratory to have this blood work done?

        Also, I have another issue aside from statin use. I have been in and out of the hospital since 12/18/10 with respiratory issues. Diagnosed with severe bronchitis, aI had my first asthma attack and it was traumatic for me. I am emotionally troubled still because I am still wheezing on expiration. I am using albuterol and was prescribed the other inhaler called…I can’t think of the name now but begins with an A- I read the side effects and one of them directly says it can cause death. I have not touched this. I just found out there is a family hx of asthma but to just have one so impromptu! What do you suggest since this is an inflammatory disease? I am 56.5 years and emotionally feellike I’m bottoming out!

        • The laboratory is the Inflammatory Markers Laboratory. You can call my assistant at 781-639-1214 to get some information on the labs and the testing.

          It definitely sounds as if you systemic inflammation problems. Your number one step should be following an anti-inflammatory diet.

  15. I posted a comment yesterday that included the above link to the UCSD statin study. I received a message that the post was awaiting moderator review, but when I linked back on today I am not sure it went through. Please let me know if I need to repost. Thanks!

  16. Thank you for bringing this matter to light. I would like to share my concerns related to statin medication and the acceleration of dementia and a life threatening heart arrhythmia that developed suddenly and without warning in my 77 year old mother. She has a history of high cholesterol with low triglycerides (70-80 range) and has never experienced a heart attack or stroke. Aside from mild dementia two years ago she is in perfect health. Her blood pressure is good, weight is low to normal, and she walks two to three miles a day. We noticed last summer that her dementia was progressing at an alarming rate. What I did not know was that her physician prescribed statins in June. I was further alarmed when I came across research related to cognitive impairment and statin use, and although her dementia was diagnosed well before the introduction of statins I felt that the acceleration may be related. Another important consideration is that her cholesterol responded rapidly with a nearly 100 point total drop in 4-5 months. After five months on statins she was admitted to the ER because she lost consciousness at home. While in the ER she coded three times but the episodes were brief and tests revealed no brain damage. There was also no heart attack or stroke. When I asked the cardiologist why she suddenly developed an arrhythmia and if this could be related to the statins I was told it was unrelated. And while he may be correct, it concerned me that neither he nor her primary care physician were aware of the UCSD research or concerned enough to make further inquiries. The issues I raised were valid and conducted by a well qualified and respected UCSD research physician, Beatrice Golomb, ND, PhD. Since we live in San Diego and the university research is widely available it seems local clinicians would avail themselves to this vital resource.

    With regard to the use of statins and cognitive impairment, I can’t help but wonder if statins may cross the blood brain barrier disproportionally in women since women appear to be more at risk of this noted side-effect.. With regard to my Mom, the rapid decline in total cholesterol and the acceleration of dementia seemed to warrant further investigation.

    I think it is vitally important to make the public aware of statins side-effects and that physicians be required to report adverse outcomes so that the dots can be better connected. Further studies that look at the correlation between arrhythmia, statin medication, and total cholesterol in the elderly are also sorely needed.

    • Your earlier post did get through. Here is my answer again.

      “It is obvious that you had done your homework on statins and the physician had not done his. I would suggest this would be a good time to seek another physician. That’s what you would do if an such response from a lawyer or an accountant.”

  17. Dr Sears,

    I read your first book many years ago and realized that your knowledge would keep me healthy and alive for many years. I have a copy of every book you have written. Every now and then I cheat, but for the most part, I follow the Zone thinking with all of my food intake. I am now 74 years old and feeling great!! I recently saw a gerontologist who told me that I should live beyond 90 years old, based in my history and current health.

    I was told that I was pre-diabetic when I was in my mid 40s. I made a decision that I would not get diabetes. I studied diets that were prescribed for diabetics by other countries, China and India and America. I had blood sugar drops constantly for over a year, but they finally stopped after I totally deleted sugar, artificial sweeteners, starchy vegetables and white flour from my diet.

    I usually eat 6 small meals a day. I learned about 7 proteins,9 carbs,3 fats from you. My life was changed. My health continued to improve. The local TV station interviewed me and I gave you all of the credit. You showed me a simple way to look at food. Every now and then, I cheat, the most part I am always in the Zone.

    I am so happy that you were called to serve this purpose in life. You have saved many lives by looking outside of the box. I’ve always wanted to thank you….so thank you!

    Jeanette Wallen

  18. Well as a practicing PA-C, it is very difficult to get patients to make any changes to their diet. We are also liable for their care. I think statins are prescribed more because we do not want to be sued .
    I have seen good results from the few patients who have tried the Zone diet though. I recommend it often.

    • What is often overlooked by the medical establishment is that insulin stimulates the enzyme (HMG-CoA reductase) that increases cholesterol production in the liver. This is the same enzyme that statins inhibit. It makes far more sense to elevated cholesterol by lowering insulin by the anti inflammatory diet as opposed to giving statins. Furthermore, cholesterol was never the problem with heart disease. Increased inflammation is the reason. This is why aspirin is still the best drug for reducing a heart attack. It doesn’t lower cholesterol, but it does a good job of lowering inflammation. If there was any problem with cholesterol, it was with oxidized cholesterol. This is best measured by the levels of oxidized LDL particles. This clinical test is far more predictive of future heart disease than is total LDL cholesterol. The best way to reduce oxidized cholesterol and oxidized LDL particles is to consume high levels of polyphenols.

  19. Hi Dr. Sears,

    I’ve been a Zoner for years. I’m convinced!

    What I am concerned about is whether some protein powders have oxidized cholesterol in them. Many protein powders are made out whey protein concentrates (which is derived from milk) and include moderate amounts of cholesterol. My fear is that this cholesterol in the protein powder has been oxidized. Is it safe to assume that any protein powder that has cholesterol in it (from the milk derived whey) would be oxidized cholesterol?

    Thanks much,
    Gene

  20. Dear Dr.Sears,
    I am in zone for more than four years and it made great improvement in my life, so I am very grateful to you and I highly appreciate your work. But I need your advice. I have a friend who had an heart attack three years ago. There was a clot that stopped blood through her veins. After that I tried to put her on the zone diet (not so strict) and I made her take Omega3RX together with a drug therapy (with statins among other drugs). First period I was a bit afraid because she was taking varfarines to prevent making new clots, and doctors didn’t like idea of taking omega3 together with it. Reading your books and articles I found that there should be no risk and she continued. Very soon her doctor stopped with varfarines because exams show she don’t need them any more. Her blood tests were OK, she feels well. After almost two years she wanted to quit with statins being afraid of some side effects, so she increased Omega3 (Enerzone Omega3Rx, we are from Croatia) to 5g of daily intake of EPA/DHA. She made a blood test few days ago, her cholesterol is above limit, her triglycerides are very low, HDL good, TG/HDL far less then 0.5 and LDL above limit (but I think those are fluffy particles). In our country I tried to find lab to make SIP test, but nobody knows anything about it.
    My friend feels no problems with hearth, she is in good shape, walks, drives bike, skies in winter, swims in summer…
    But still, I am concerned is it OK to give up statins in her situation, because you stated that statins are not good only for people who didn’t have heart attack. But what in her case? Is there any danger if she is not taking statins?
    Dear Dr.Sears, thank you in advance for your advice and help.
    Marija

    • That’s a decision best made by her physician. Hopefully she can share the information in my blogs with her physician. But the proof is often in the physical results (low TG/HDL ratio, etc). For your friend they seem remarkable.

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