Don't lament no OTC mevacor

After Merck's third go at FDA approval for over-the-counter (OTC) status for its statin cholesterol drug, Mevacor (lovastatin), the FDA advisory board suggested that its request be denied. They expressed concern that too many people would not understand how the drugs would be used and that misuse would be common.

Similar sentiments were echoed by Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen; the American Medical Association (though the AMA always fights anything that threatens to erode physician control over health); and the de facto spokesman for cardiologists, Dr. Steven Nissen of the Cleveland Clinic.

Although I am a supporter for tools and legislation that yield greater self-empowerment in health care to the public, there is no need to lament the failed OTC status for Mevacor. For one, Merck had no plans to reduce the price on its OTC preparation. For many people, this would have meant an increase in cost, since health insurers would surely not cover a non-prescription agent.

Second, OTC status sends the implicit message that cholesterol is the most common cause of heart disease; it is not. (Small LDL particles are the number one cause, a pattern only partially addressed by any statin drug and a pattern largely responsible for the failure of statin drugs to "cure" heart disease despite pharmaceutical manufacturer's attempts to increase doses to take up any slack in effect.)

Thirdly, you can achieve the same effect--no, a superior effect--by incorporating several simple strategies into your life. These strategies are superior to Mevacor because they do more than just reduce LDL cholesterol. You can achieve similar LDL-reducing effect to Mevacor, 20 mg, just by adding:

--2 tablespoons oat bran or ground flaxseed per day (choose flaxseed if you have sugar problems or small LDL; flaxseed contains no digestible sugars, only protein and fiber)
--Raw almonds or walnuts--at least a handful, though more is fine and will not make you fat. (It's nuts like party mixes, mixed nuts roasted in unhealthy oils, and honey-roasted nuts that make us fat, not raw.)
--Soy protein sources--probably the weakest effect of all foods listed, but a contributor that can be obtained in a variety of forms, such as tofu, soy protein powders, and soy milk.
--Other foods that reduce LDL include pectin sources (e.g., citrus rind), flavonoids (e.g., green tea); stanol esters found in butter substitute Benecol (recall that sterol-containing products like Take Control and the flood of new products on the market like HeartWise orange juice might have potential for allowing sterol esters to enter the blood, so I do NOT recommend them); and, of course, niacin.

Many of these strategies also reduce small LDL, raise HDL, reduce triglycerides, and reduce blood sugar, effects that go beyond that achieved with Mevacor. Of course, a combination strategy is not as easy as popping one pill a day, it's better for you.

I will certainly not shed any tears for Merck and its relentless efforts to gain a stronger foothold in the "transform conditions into diseases" marketing strategy, the same strategy that classifies shyness, toe fungus, and sadness into medical conditions necessitating medication. While I do generally support efforts to increase public access to strategies that increase their health care power, this one was not necessarily all good.

Members of Track Your Plaque can read the complete report, Unique nutritional strategies to Reduce cholesterol naturally on the Track Your Plaque website.



Copyright 2007 William Davis, MD

Comments (4) -

  • Anonymous

    12/18/2007 10:30:00 PM |

    Dr. do psyllium husks also reduce small ldl ?

  • Dr. Davis

    12/19/2007 3:46:00 AM |

    Not specifically. They reduce total LDL of all sizes.

  • Anonymous

    12/19/2007 10:21:00 PM |

    Ok I'm sorry but I'm confused. Does ground flax seed help get rid of small ldl or is it just like psyllium husks and reduces all ldl?

  • Dr. Davis

    12/20/2007 4:55:00 AM |

    Mostly total.

    There may be a slight preference for small LDL, but documentation is rather skimpy.

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How far wrong can cholesterol be?

How far wrong can cholesterol be?

Conventional thinking is that high LDL cholesterol causes heart disease. In this line of thinking, reducing cholesterol by cutting fat and taking statin drugs thereby reduces or eliminates risk for heart disease.

Here's an (extreme) example of just how far wrong this simpleminded way of thinking can take you. At age 63, Michael had been told for the last 20 years that he was in great health, including "perfect" cholesterol values of LDL 73 mg/dl, HDL 61 mg/dl, triglycerides 102 mg/dl, total cholesterol 144 mg/dl. "Your [total] cholesterol is way below 200. You're in great shape!" his doctor told him.

Being skeptical because of the heart disease in his family, had a CT heart scan. His coronary calcium score: 4390. Needless to say, this is high . . . extremely high.

Extremely high coronary calcium scores like this carry high likelihood of death and heart attack, as high as 15-20% per year. So Michael was on borrowed time. It was damn lucky he hadn't yet experienced any cardiovascular events.

That's when Michael found our Track Your Plaque program that showed him how to 1) identify the causes of the extensive coronary atherosclerosis signified by his high calcium score, then 2) correct the causes.

The solutions, Michael learned, are relatively simple:

--Omega-3 fatty acid supplementation at a dose sufficient to yield substantial reductions in heart attack.
--"Normalization" of vitamin D blood levels (We aim for a 25-hydroxy vitamin D level of 60-70 ng/ml)
--Iodine supplementation and thyroid normalization
--A diet in which all wheat products are eliminated--whole wheat, white, it makes no difference--followed by carbohydrate restriction.
--Identification and correction of all hidden causes of coronary plaque such as small LDL particles and lipoprotein(a)

Yes, indeed: The information and online tools for health can handily exceed the limited "wisdom" dispensed by John Q. Primary Care doctor.

Comments (32) -

  • Jan

    8/17/2011 6:36:25 PM |

    Time to stop bashing primary care docs, doc. Online sites are full of B.S.
    Show me the evidence that testing with CAC improves outcomes (Sure it predicts risks, not the same as actually preventing disease, especially in those at lower risk of CAD.)

  • Might-o'chondri-AL

    8/17/2011 8:11:19 PM |

    Hi Jan,
    Since you accept plaque showing up as being a cardio-vascular risk factor then if Doc reports he has treated some patients whose measurement of plaque has diminished using his protocol would you also accept the proposition that those patients have reduced one of their cardio-vascular risk factors?
    If Doc has patient records showing diminished plaque and therefore one less risk might that not be considered preventative due to his patient following his protocol ?
    As for those individuals with hypothetically lower risk of CAD (ex: the 63 year old low cholesterol example Doc gave) are they not going to undergo changes as they age ?  
    A primary care physician is valuable and yet older westerners are increasingly engaging specialists for good reasons.  Doc has a self-professed specialty tracking plaque  that he wants to impart; sure, his blogging tone may not always be mellow.

  • Jan

    8/18/2011 2:52:13 AM |

    Dear Might,
    Your comment is akin to those who report the association of statin use with lowered risk of MI. A correlation does not prove causation until valid  scientific research confirms.
    How do we know treating CAC lowers risk of MI until a study proves this? Docs have been wild to accept the association of statin use lowering cholesterol components as the mechanism of effectiveness for prevention of MI, ignoring studies in which dietary measures that did the same were ineffective. Just pointing out the need for caution in going so far as to treat a test without evidence that the intervention is working on the test findings (rather than something else).
    Perhaps there are studies that are underway or perhaps the evidence, er association, is just considered too strong, (Bradford-Hill criteria) to ethically justify a trial. My concern is for individuals who score in the lower range of abnormal. At what cost do we label and treat those?

  • joel oosterlinck M.D.

    8/18/2011 9:21:42 AM |

    just remembret the lyon heart study, by  Renaud & de Lorgeril demonstrating the efficacy  of mediterranean diet in lowering the risk of recurrent MI in French patients. although cholesterol levels were higher with diet than with statins. Dietary measures seem there to demonstrate  efficacy

  • Dr. William Davis

    8/18/2011 12:15:43 PM |

    Not only is it NOT time to stop bashing primary care docs, but it's time to begin accepting that their role is outdated. In fact, an average nurse practitioner or physician's assistant can do an equal, if not better, job than most primary care physicians. How health care is dispensed is going to undergo dramatic transformation, just as the business of travel agents and real estate have been transformed by rapid information exchange.

    In our program, we see virtually NO heart attacks. Not a randomized clinical trial, but watching heart attacks drop from a weekly event to almost never is good enough for me to not accept the status quo and continue to work along a path that, from every indication, works exceptionally well.

  • JC

    8/18/2011 12:49:19 PM |

    If high crab diets are considered unhealthy then why do some cultures like the rural Chinese live long healthy lives on nearly 100% crabs,mostly rice and vegetables?

  • majkinetor

    8/18/2011 2:16:50 PM |

    Isn't the best thing for calcium on wrong places vitamin K2 ?
    In my country doctors even prescribe it for calcification issues.
    Dose is around 100mcg/day for 6-12 mo.

  • Marlene

    8/18/2011 4:06:07 PM |

    Read Gary Taubes' "Good Calories, Bad Calories" to find several instances of other cultures eating the typicial high carb food yet seemingly stay within the healthy range.

  • Jan

    8/18/2011 4:22:12 PM |

    Trust my care (or a family members care) to a NP or PA who does not have the capability of complex medical decision making - no thanks. NP's actually are complimentary to physicians with different skill sets. So glad to know your level of knowledge about them. PA's are nothing but junior medical students with enormous salaries. Working 9 to 5 - oh, yeah!

    I'm certain your referral network of primary care docs would be interested in your belief system.

  • Joe

    8/18/2011 4:49:51 PM |

    Dr. Davis:
    I don't know if you've seen this new video yet, but I think you'll want to.
    http://www.youtube.com/watch?v=3vr-c8GeT34&feature=player_embedded
    If you do watch it, I have a question. This doctor thinks sugar (by itself) plays a huge role in causing plaque to rupture and cause heart attacks, etc. If after watching the video you agree with him, would you please tell me how (biologically) it does this?
    Thanks!

    Joe

  • Might-o'chondri-AL

    8/18/2011 8:51:08 PM |

    Hi Jan,
    True correlation does not necessarily equate to causation. As for statins, it seems that statins act to lessen inflammatory processes; and it is this dynamic, rather than numerically lowering cholesterol, that is a crucial way that statins correlate with reduced risk. Which, to me,  seems to further support Doc's contention here in this posting that  low cholesterol levels doesn't  tell one if they have abnormal plaque (ex: patient above with "exceedingly high" score) .

    I will accept Doc's data, as given ,that very high plaque is a 15-20% risk factor since many other published sources cite even carotid plaque as a risk factor . As far as who to test for what, and when, I am not qualified to make recommendations. I do know that time can remodel some cellular dynamics and the aging cardio-vascular system is vulnerable to alterations.  Doc's got my attention because no one at all in my paternal male ancestral line lived past their late 50's due to heart problems and I am 60; while my 61 year old brother already was hospitalized from transient ischemic attack  .

  • Might-o'chondri-AL

    8/18/2011 9:33:17 PM |

    Mediterranean diet's efficacy for heart health is probably due to the % of poly-amines per calorie consumed and of course isn't in keeping with Doc Davis' detestation of modern wheat (among other protocols). As we age our poly-amine levels decrease and Mediterranean diet supplies lots of poly-amines.

    Poly-amines ( molecules inelegantly named spermine, spermadine and putrescine) are all anti-inflammatory, especially spermine; in our body we synthesize poly-amines from arginine. Mediterranean diet's high poly-amine levels spares the amount of arginine our body uses in synthesizing poly-amines; and thus we can more readily produce the vaso-dilator signalling molecule NO (nitric oxide) from body's arginine. NO is valuable to keep oxygenated blood reaching the heart muscle cells; NO keeps vessels from constricting dangerously.

    Poly-amines lower inflammation and in the context of age associated problems the less low grade inflammation the better.  Inflammation leads to defectively functioning cells and molecular processes; with time the  over stimulation of immunological responses (both innate and adaptive immunity) leaves the body burdened with unknown clones of T cells (both memory and effector types). Eventually the build up of  T cell clones limits new variants and what occurs is more macrophages circulating; once an over abundant macrophage stage reins the body is essentially always in low grade inflammation , and prone to various age associated pathology (including cardio-vascular).

  • Dr. Johns

    8/19/2011 12:25:40 AM |

    @jan....
    A vast majority of primary care doctors are extremely limited in their abilities to treat/advise patients for CVD risks. They don't understand nutrition, effects of supplements upon serum biomarkers, nor effective diagnostic testing for heart disease.
    CAC is a much better biomarker for who is at greater risk of CVD than serum markers:
    http://www.eurekalert.org/pub_releases/2011-08/jhmi-sfc081611.php

    I seriously doubt even 1:100 primary care docs see studies like the aforementioned one.
    And I seriously doubt the one doc would understand it....
    Dr. John

  • Gene K

    8/19/2011 1:48:19 AM |

    An interpretation of the same study for a broader audience just appeared at http://www.webmd.com/heart-disease/news/20110818/is-calcium-test-the-best-way-to-check-for-heart-risk.

  • Thomas White

    8/19/2011 2:09:49 AM |

    I'd accept a bashing of physicians in general.   But to single out primary care physicians - overwhelmed with paperwork and patients with multiple problems, and vastly underpaid and underappreciated, and continually put down by "Partialists" - Really ? Cardiologists are superior? Really ?

    Forget my support and admiration henceforth.

  • Might-o'chondri-AL

    8/19/2011 5:43:43 AM |

    CRP (C-reactive protein), an inflammation marker surrogate, does not directly correlate with whether there is coronary artery calcium (CAC), or the degree of CAC severity. CRP is also subject to variables of race and age, so it loses some potential as a predictive marker. Yet looking at CAC along with CRP is considered useful for complex insight into a patients pathology.

    Analysis of the Multi-Ethnic Study  of Atherosclerosis (MESA) involving 6,800 men & women seems to indicate that inflammatory markers (ex: CRP) relate to the physiology of pathological processes other than CAC laid down; possibly because plaque undergoes morphological changes over time. The CRP level is proposed, by some, to relate more to the stability of plaque from rupturing and the incidence of blood clotting in a thrombosis.

    The inflammatory marker of Interleukin-6 (IL-6) anti-bodies seems to be better than CRP and fibrinogen for correlating an individual's trend toward CAC. Thus the cytokine IL-6 is a better indicator of sub-clinical atherosclerosis; Doc likes to cut to the chase, eyeball the plaque and track it with current technology ( that is not available worldwide).

  • David

    8/19/2011 6:16:33 AM |

    Is it typical for someone with such low ldl and high hdl to have such a high CAC score? Had he previously had a higher LDL and then been placed on a statin?

  • TT

    8/19/2011 12:36:37 PM |

    The energy expenditure of the rural Chinese is very high.  They don't drive, they walk, or ride bicycles.  They don't sit in office from 9am to 5pm, they work hard in the rice field from 5am to 9pm.  They can eat anything without gaining weight.
    For the urban Chinese, it is a different story.  They have the same life sytle as ours, and they are getting heavier every year.  More and more people become diabetic, even young kids.

  • Dr. William Davis

    8/19/2011 1:51:32 PM |

    K2 is indeed a fascinating nutrient. There are extensive discussions about it on the Track Your Plaque website.

  • Dr. William Davis

    8/19/2011 1:53:33 PM |

    Thanks, Joe. I watched the entire thing and was impressed with Dr. Diamond's grasp of the issues.

    I'm going to post this on the main page because I think his overview was extremely effective.

  • Dr. William Davis

    8/19/2011 1:55:24 PM |

    Sorry you see it that way. This was a comment directed at the system of primary care in general.

    I reread the post and I didn't see the name "Dr. Thomas White" mentioned anywhere. If you choose to feel slighted in some way, that's your choice.

  • Kent

    8/19/2011 3:20:32 PM |

    Jan, I would certainly trust my care (or a family members care) to a NP or PA who looks outside just the pharma driven medical journals which primarily support a diagnose & drug philosophy.  And I'll take an NP or PA who actually uses some common sence rather than being a puppet given to the pushy drug rep.

    I live in a family of MD's, and they have made it clear as to their terribly limited training and knowledge they gain from med school on the level of building and supporting the body from within.  Example, I have an Aunt that is currently suffering from stage 4 cancer. Due to the chemo treatment that she's instructed to not spend time in the Sun. Her Dr. has not even checked her for vitamin D levels. This is not the exception, but the norm when it comes to common sence treatment, pathetic.

  • Joe

    8/19/2011 6:56:14 PM |

    Okay, Dr. Davis.  I'll be looking for it. When you do, please take a moment and explain how you think that sugar might be responsible for plaque rupture.
    Thanks again!

    Joe

  • steve

    8/19/2011 7:06:59 PM |

    Sugar is just one part of the equation.  As Dr. Davis has covered on this website, small LDL is also a villian and needs to be minimized as much as possible.

  • Might-o'chondri-AL

    8/19/2011 8:05:24 PM |

    Hi Joe,
    Thanx for the video ... maybe the following answers you.

    Regarding sugar: see 59:33 into presentation, where diagram shows "sugar" blurb  - lecturer is using compact word sugar to represent how glucose's glycation end products alter the artery and make the artery vulnerable. It is not a molecule of sugar acting all by itself; lecturer explains slide when talks of how glycation is a problem (another of  Doc Davis'  peeves).

    Follow up at 1:01 into presentation: see diagram's top left  where the various adverse influences on artery  are specified as "modified lipoprotein", "hemodynamic insult" (includes, but is not limited to blood sugar's  glycation end products affect on artery), "reactive oxygen species" (ROS) and "infectious agents".

  • Thomas White

    8/20/2011 12:22:15 PM |

    Thank you for all your hard work and dedication to your web site and education.

    I apologize for cluttering up the discussion with a personal statement.

    TRW

  • Joe

    8/20/2011 4:13:56 PM |

    Thank you, Might. I guess I'm going to have to do some research on glycation before I can fully understand what you're saying above.

    I didn't even notice the PowerPoint Presentation that was included with Dr. Diamond's video presentation.  Sigh.

    Thanks again!

    Joe

  • Jim

    8/20/2011 7:55:03 PM |

    AMEN! Right on target.

  • Louis

    8/23/2011 2:05:01 PM |

    I don't know if you're aware of the differences between calculated test that most doctors use and NMR that Dr. Davis uses. When your diet consists of mostly carbohydrates leading to chronic high blood sugar level, it tends to raise your SMALL DENSE LDL level but calculated cannot measure it accurately. It often greatly underestimate it.  Dr. Davis has covered it many times. Dig through his website for it.

  • Louis

    8/23/2011 2:16:27 PM |

    Optimal vitamin D level helps lower IL-6. It can be a big problem with black people as they tend to have the lowest vitamin D level of any races. Dr. Cannell mentioned that in his new book called Athlete's Edge Faster Quicker Stronger with vitamin D with the hope that the word about vitamin D would spread out faster if more and more professional athletes started using it to gain some advantage over opponents much like what East Germany and formerly USSR used to do in 1960 and 1970s at the Olympic games and other world events.

  • live-healthcare

    8/27/2011 4:31:48 AM |

    Yes Joe i have seen the video you linked. That's right i also think the same.

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