The dreaded small LDL particle

Brian is a 59-year old landscape architect whose starting CT heart scan score was 276.

Brian's food choices at the start were deplorable: a pound of sausage per week, sometimes more; butter on anything and everything; up to two pounds of cheese per week; hot dogs; etc. His lipoproteins were accordingly just as miserable: low HDL, high triglycerides, excessive (postprandial, or after-eating) IDL. Small LDL was a particularly stand-out pattern, with 95% of all LDL particles in the small category.

Brian made a dramatic turnaround in lifestyle and corrected all of his patterns--except for small LDL. After one year, small LDL still occupied 95% of all LDL particles, even though the quantity of LDL had been reduced. In order to help convince Brian that correction of his small LDL was going to be necessary to achieve control oover coronary plaque, I suggested that he undergo another heart scan. His score: 435, or a 57% increase.

Each day that passes, I gain more and more respect for small LDL as a cause for coronary plaque growth. Conventional thought among lipid experts is that small LDL should no longer be a factor if total LDL (e.g., LDL particle number) is reduced. But our experience suggests otherwise: when small LDL persists, we tend to see continued, sometimes frightening, plaque growth.

I therefore asked Brian to intensify his efforts: additional weight loss off his somewhat prominent abdomen (since visceral fat increases small LDL), further reduce wheat products and processed carbohydrates, increase niacin (to 1500 mg per day), and use more raw almonds and oat bran.

Don't let small LDL get the best of you. It is a nasty, sometimes persistent abnormality that has impressive effects on plaque growth.
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Response from Nature Made

Response from Nature Made

Here's the response from Nature Made when I emailed them about my concern that there appears to be no vitamin D in their vitamin D gelcaps.

It is the usually CYA corporate-speak that says nothing. The grammatical errors make it clear that this was a "canned" response.



Date: April 9, 2010
From: Marissa Reyes, Consumer Affairs Department
Subject: Reference #346236

Dear William Davis, MD:

We recently received your e-mail regarding Nature Made products. We regret to
hear that the quality standards of our company. [?]

Our company is called Pharmavite, and we manufacture Nature Made nutritional
supplements. We have been in business since 1971. We are committed to quality
control, and have very high quality standards. Our Quality Control personnel
sample and test all raw materials as they enter our plant, and again assay the
finished product, before final packaging.

Dietary Supplements are regulated under the FDA through DSHEA (Dietary
Supplement Health & Education Act of 1994). The United States Pharmacopoeia
(USP) establishes standards for the composition of drugs and nutritional
supplements. This voluntary non governmental organization was set up in 1820
and has officially been recognized by federal law since 1906. Standards
established by USP for products are legally enforceable by the FDA. At
Pharmavite we participate in the USP Dietary Supplement Verification Program
(DSVP). Many of our products have earned the DSVP seal and additional products
are currently being evaluated. Our DSVP certified products will have the DSVP
seal on the product label.

Our Nature Made Vitamin D 400 IU tablets have been reviewed by the USP and bears
the DSVP symbol on the label. Although the USP has not reviewed all of the
Nature Made Vitamin D supplements, all of our products go through the same
rigorous quality testing at Pharmavite. The products which have earned the seal
help us to demonstrate the high quality of our products.

We would like to look into the product(s) your patients have been using. If you
could provide the UPC and lot numbers of the product(s), we will be happy to
review our records. In addition, if you would like us to test the product(s)
that you currently have, we will be pleased to send a prepaid postage mailer so
you may return the product(s) to us so that our Quality Control Department can
examine it. Please let us know if you would like us to send you the prepaid
postage mailer.

We thank you for contacting us and hope that you will continue to use and enjoy
Nature Made products with complete confidence.

Sincerely,
Marissa Reyes
Consumer Affairs Coordinator
Pharmavite, LLC
MR:346236-10



Patients who come to the office do not provide me with the bottles nor lot numbers. In past, when I've gone to the trouble of doing this (with other companies, not Nature Made), it has come to nothing helpful. The information gets passed on to the company and we hear nothing and never learn if there was a problem, or receive some more corporate-speak letter saying everything was fine. This is obviously a liability-avoidance tactic: Admitting that something was wrong would open them up to legal risk. So, frankly, I can't be bothered.

So we are left with the unsatisfying experience of relying on street-level experiences.

For now, my advice: Avoid Nature Made vitamin D. Too many people have had blood tests demonstrating that they are not obtaining any vitamin D.

By the way, the Nature Made brand of fish oil is among the very few problem brands of fish oil we've encountered. Fish oil should be only mildly fish in smell and generally should not cause stomach upset and excessive belching if properly purified. Nature Made is excessively fishy when you smell it, suggesting oxidation. We've had repeated (dozens) of patients who have experienced difficulties with this brand. Rather than dealing with the frustrating gobbledy-gook of this company, just avoid their products.

Comments (31) -

  • Tony

    4/10/2010 1:40:39 PM |

    I've been using the NatureMade fish oil because it's frequently 2-for-1 at Rite Aid. My VAP cholesterol test was excellent while on the product, but I suppose that doesn't ensure that the product is doing anything. Thanks for the info.

  • Anonymous

    4/10/2010 3:06:53 PM |

    Fresh fish does not smell like fish. Only when the fish tissue starts to decompose does it start to smell like "fish".

  • Impudent_Observer

    4/10/2010 3:31:05 PM |

    First of all, Doc, thanks for taking the time to do this blog. It's great to have such an expert "in the trenches" practitioner helping ordinary people like me make much better decisions on keeping my heart going!
    Specifically on this post, when you write these companies, I'd suggest writing a letter and sending it by post right to the CEO.
    I've found that usually gets a better, more personalized response to my concerns.

  • gindie

    4/10/2010 3:44:38 PM |

    What is a person with very low Vitamin D levels, but prone to kidney stones, to do?

  • whatsonthemenu

    4/10/2010 4:34:04 PM |

    I wonder if that letter was generated by a worker at an overseas customer service center who, as you suggested, just opened a file and inserted text.  How many hits does your blog get?

  • Anonymous

    4/10/2010 5:36:51 PM |

    I've wondered if the USP seal on vitamins actually means anything -- apparently, it doesn't count for much.

    I have had a company actually admit to a problem with their supplements once (Jarrow), where their Ubiquinol gelcaps were leaking (found goo at the bottom of my bottle). They admitted the capsules were faulty and they planned to change the manufacturer of their gels, and even sent me a replacement bottle. So... some companies will actually admit to problems and take care of them, but that is still probably the minority.

  • Gary Wu

    4/10/2010 5:45:05 PM |

    Hi Dr. Davis,

    Have your patients had any experience with CostCo's 2000 IU vitamin D3 gelcaps?

  • Painlord2k

    4/10/2010 5:55:53 PM |

    In Italy, Vit D3 drugs are available over the counter at pharmacy. They are ultra cheap. I go for an injection every 2 months as 5 vial cost less than five €.
    What prevent US consumers from going to a pharmacy and buy registered drugs instead of supplements?
    Quality control for drug companies is surely a bit harsher than for supplement companies.
    Then, regulation can be different.

  • Nancy

    4/10/2010 8:11:24 PM |

    good to know, I used to buy Nature Made all the time... now I am wondering if the "gummy bear" vitamins and vitamin D I give my kids actually are vitamins.  What if they are just candy.  How can you tell for sure?

  • Dr. William Davis

    4/11/2010 1:04:57 AM |

    Impudent--

    Great idea.

    Perhaps I will send future emails and say that there are thousands of people reading this blog who will await their response!

  • Dr. William Davis

    4/11/2010 1:05:51 AM |

    Gary--

    Because we have only one Costco (i.e., only one store), we have had too few people buying this product to say with any confidence.

    It never hurts to have your blood level checked.

  • rhc

    4/11/2010 1:40:53 AM |

    You might consider me 'weird' but  I actually like to chew my fish oil capsules - I like the taste of the oil and the capsule itself. This has an added important benefit: I can taste if it's fresh BEFORE I swallow. I must say I've never had a rancid one yet. Presently am using Spring Valley from Walmart. I often do the same with my liquid vit D3 caps as well.

    Dr. Davis, thank you so much for all the info you put out for us.

  • Anonymous

    4/11/2010 1:54:25 AM |

    I am a fan of your blog, but honestly this is a very low standard of "proof" that you are using. If you feel strongly about it why not get a certificate of analysis done yourself?

  • Daniel Schroeder

    4/11/2010 4:00:08 AM |

    I'm a psych NP. My patient took 7000iu Naturemade tabs with no effect on blood level after 2 months. Have heard tabs don't absorb, so have stearing people away from them. Thanks for the info on their softgels.

  • Dr. William Davis

    4/11/2010 1:05:50 PM |

    If I had to get a "certifcate of analysis" performed for every supplement I questioned, we'd go bankrupt just on the testing.

    I'll be interested to see what organizations like Consumer Lab, who test a broad range of supplements, come up with.

  • TedHutchinson

    4/11/2010 7:41:25 PM |

    I subscribe to Consumerlabs.

    When they tested vitamin D3  (1/18/10) they only tested up to 1000iu/d capsules/tablet/liquid and also some combination products.

    I'm sure readers here are all aware  1000iu/daily can, at best, only raise 25(OH)D 10ng/ml = 25nmol/l.
    Most readers require significantly more than that to reach >50ng/ml+ ensuring their body has an emergency stored reserve supply of Vitamin D3.

    People who are overweight or suffer diabetes, Celiac or any other inflammatory condition will generally require even more than 1000iu/daily/D3 per 25lbs weight.

    The LEF report Startling Findings About Vitamin D Levels in Life Extension® Members By William Faloon shows IN PRACTICE 5000iu/daily/D3 averages only just above 42ng/ml so if we are trying to achieve a level that does more that just meet our daily requirements but also enables the body to store Vitamin D for emergencies, then we require MORE THAN just 5000iu daily/vitamin D3.

    At latitude 52 with a BMI just under 25 I take 5000iu/daily + regular short full body prone uvb/winter/sun/summer exposure
    My 25(OH)D stays @ 64ng/ml.

    I am not convinced Consumerlabs testing of tablet formulations of 400iu or even up to 1000iu has any relevance to correcting vitamin D insufficiency.

  • Douglas Jones

    4/11/2010 11:10:00 PM |

    Dr. Davis

    My name is Douglas Jones, I am with in Corporate Communications at Pharmavite the makers of Nature Made Vitamins.  We take your comments very seriously and need the information that Marissa asked for in her e mail.

    All of our products are tested fully before they are shipped to our customers.

    Please feel free to contact me directly at djones@pharmavite.net

    Thank you

  • Dr. William Davis

    4/12/2010 11:34:16 AM |

    Thank you, Mr. Jones.

    Because I identify these cases one by one over months, I don't have my patients bring in their bottles.

    I have to say that I am also impressed that I got beyond the girl in the cubicle on this one.

    In future, I will ask patients to bring the bottles in. If I know this leads somewhere, then it's worth the extra effort.

    However, I remain confident that there is a problem.

  • Heather Brandt

    4/13/2010 10:10:58 PM |

    Do you recommend multivitamins and/ or Vitamin D brands?

    I am 34 years old and at an ideal body weight but had moderately low HDL when blood work was done...Just following your blog and trying to figure out ways to raise my HDL and to help prevent heart disease (My mother is in her 50s and has been on statins for bad cholesterol, a path I don't want to follow).

    heatherlbrandt(at) verizon (dot) net

  • Anonymous

    5/18/2010 10:34:01 AM |

    I had been using NatureMade fish oils for years and no belchback. I got a batch that both my wife and I had bad belching with fish taste. Called the company and they said I had been using the enteric coated. I bought some of the enteric and they don't belch back, they also are not what we had been taking. Looks like I will be switching to a different company too.

  • dining tables

    7/6/2010 3:44:11 AM |

    My friends have been using NatureMade fish oil for over a year now. She told me that it is very effective. I think I am guess I will giving it a try.

  • Trem papers

    8/16/2010 10:25:23 AM |

    Hi, nice post. I have been thinking about this topic,so thanks for sharing. I will likely be coming back to your blog. Keep up the good work
    termpapers99@gmail.com

  • dlrose123

    10/19/2010 2:03:49 AM |

    In Nature Made's defense, I've been using 2,000 Vitamin D from Nature Made for the past 6 months, and my Vitamin D levels have risen about 20 points.  I've been very happy with the result, so I just started using their fish oil. I'm sitting here with a brand new bottle of their fish oil enteric coating 1200 mg pills, and smell no odor at all.  This doesn't mean other people haven't had different experiences, but it might be very dependent on your individual body chemistry, and I would suggest doing blood tests every 6 months to determine if the Vit. D you are taking is working for you.  And no, I do not work for Nature Made, and have no connections to them Smile

  • auto insurance quotes

    3/9/2011 1:13:12 AM |

    I just have to say that letter show what they think of customers and how they have made made their mind to deal with any complaints. They did not even bother to get a competent person who could write a letter. Forget that. They did not even bother to prepare a template response.

  • Anonymous

    3/17/2011 5:35:13 PM |

    There is interesting research on omega 3 bioavailability.

    After mixed results with various fish oil capsules resulting in low-tide burps or flatus, i moved to Coromega.  Wonderful product.

    Re Costco 2,000 iu oil capsules, i've raised my serum levels to 88 ng/ml with them.

    However, given the wide range of factors that affect D uptake/utilization, titrating to standard is the only useful methodology. Blind dosing, especially at very low serum levels, might not raise serum levels at all.

  • Anonymous

    3/17/2011 7:03:36 PM |

    Omega-3 structure may affect bioavailability: Study

    By Nathan Gray, 14-Jan-2011

    Related topics: Research

    The type of omega-3 we take may have a distinct affect on how much is actually absorbed, according to new research.


    The study, published in the European Journal of Lipid Science and Technology, suggests that omega-3 concentrates – such as triacylglycerides – have much better bioavailability than purified fish oild

    The team of Spanish researchers said that the study contributes to knowledge on the intestinal lipolysis of omega-3 sources, which can be found in many commercial forms, from purified fish oil to concentrates of free fatty acids and ethyl esters.

    They said that despite differences regarding their intestinal metabolism, there is lack of information about the specific composition of the absorbable fraction from omega-3-TAG or omega-3-EE concentrates.

    “This comparative study showed that the in vitro bioaccesibility of omega-3-polyunsaturated fatty acid (PUFA) seems to be better as omega-3-TAG concentrates than purified fish oils,” said the researchers, led by Dr. Diana Martin from the Universidad Autónoma de Madrid, Spain.

    Fish oil

    Consumption of fatty acids from the omega-3 family – particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – have been advised due to their beneficial role as anti-thrombotic, anti-inflamatory, and hypolipidemic fatty acids.

    The authors noted, however, that in many populations consumption of fish is quite low and does not achieve levels adequate for reaching the minimal intake level of EPA and DHA. They added that because of this, an easy way of increasing omega-3-polyunsaturated fatty acids (PUFA) intake is by the fish oils supplements oils.

    They said that recent studies have produced contradictory evidence for the in vitro metabolism of fish oils and omega-3-concentrates,

    The new study compared the in vitro bioaccesibility of omega-3-oils from different sources. The researchers tested salmon oil, tuna oil, enriched-omega-3 oil as triacylglycerols (omega-3-TAG), and enriched-omega-3 oil as ethyl ester (omega-3-EE).

    Study details

    Dr Martin and colleagues reported the rate of hydrolysis of omega-3-TAG concentrates was continuous throughout the time of reaction, whereas the digestion of salmon oil and tuna oil was initially faster but stopped after 10 min.

    They added that poor hydrolysis took place for the enriched-omega-3 oil as omega-3-EE.

    The breakdown of omega-3-TAG oil, salmon oil, and tuna oil mainly consisted of free fatty acids (FFAs) and monoacylglycerides, whereas the breakdown from digested omega-3-EE oil consisted of free fatty acids and undigested ethyl esters.

    “This comparative study showed that the in vitro intestinal digestion of omega-3 (EPA and DHA) sources as fish oil, triacylglycerides, or ethyl ester concentrates was different,” said Martin and colleagues.

    “The highest degree of hydrolysis and inclusion of lipid products … was found for the omega-3-TAG oil, but compared to fish oils long times of digestion were required,” they added.

    Source: European Journal of Lipid Science and Technology
    Volume 112, Issue 12, pages 1315–1322, doi: 10.1002/ejlt.201000329
    “Intestinal digestion of fish oils and ω-3 concentrates under in vitro conditions”
    Authors: D. Martin, J.A. Nieto-Fuentes, F.J. Señoráns, G. Reglero, C. Soler-Rivas

  • Anonymous

    3/17/2011 7:04:21 PM |

    http://www.adajournal.org/article/S0002-8223(09)00293-4/abstract

  • Anonymous

    3/17/2011 7:15:55 PM |

    Re vitamin D uptake & utilization, diet (taking D with a meal doubles uptake), existing D levels (see Holick re substrate starvation), D form (D2 v D3), exposure, lifestyle, age (over 50 produce less in skin), obesity (excess bf sequesters D), co-factors (affect utilization), genes, bathing (bathing strips oils off skin), etc. affect D serum levels.

    http://www.scribd.com/doc/38595990/D2-D3

    http://www.scribd.com/doc/37319962/Vieth-Vit-D

    http://www.scribd.com/doc/36940698/D-Test-and-Treat

    http://www.scribd.com/doc/45004628/D-review

    http://www.scribd.com/doc/49369766/Garland-021811

    "Vitamin D has co-factors that the body needs in order to utilize vitamin D properly. They are:
    magnesium
    zinc
    vitamin K2
    boron
    a tiny amount of vitamin A
    Magnesium is the most important of these co-factors. In fact, it is common for rising vitamin D levels to exacerbate an underlying magnesium deficiency. If one is having problems supplementing with vitamin D, a magnesium deficiency could be the reason why."

  • K.N.O.W. (Kids Need Our Wisdom)

    3/27/2011 9:30:17 AM |

    Dr. I came across your site while looking for someone who was having the same problem w/ their Vitamin D levels and not finding a solution.  In fact, the brand you mentioned has done nothing for me in any of the vitamin area!  However I did come across a vitamin that has taken care of my Vit D problem and other problems.  Honestly I think the brand I am taking is the ONLY brand that is actually helping people.  Everyone I know who gets on them has had great results!  Rob Dillon - rdillon4@cox.net

  • Study in UK

    4/14/2011 7:54:42 AM |

    Incidentally, I like the way you have structured your site, it is super and very easy to follow. I have bookmarked you and will be back regularly. Thank you

  • gareth

    9/7/2011 10:13:45 PM |

    i too have suffered from kidney stones. i did a 24 hour urine test and my calcium urine level was 3 times normal. shock horror all round.
    i began to take 5000iu of vitamin d3 daily and in a few weeks my calcium urine level was normal, my urologist was amazed that this had happened but i did not tell him why because english doctors do not believe in supplements and he would have had a hissy fit!!.
    since then, no more stones!

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