(Lack of ) Quality of nutritional supplements

In my last post, I blogged about how we must not confuse marketing with truth. They are often two different things.

A patient I saw today was absolutely convinced that his fish oil was the best available in the world: purer, uncontaminated by mercury or pesticides--"not like that other crap on the shelves." I asked him how he knew this. "They say so," he proudly declared.

Do you recognize this? He fell for the marketing. While there may be some truth in the manufacturer's claims, you can't believe it from the mouth of the manufacturer. True judgements about quality and purity have to come from an independent source like Consumer Reports, Consumer Lab, or the FDA.

But the FDA doesn't regulate the quality and purity of nutritional supplements. On the positive side, this has allowed supplement manufacturers to keep costs down, not having to navigate arcane and complex regulatory restrictions.

On the negative side, a fair number of supplement manufacturers get away with 1) producing supplements that fail to contain the stated amounts of ingredients, occasionally containing none of the essential ingredient(s), 2) contain contaminants like lead, and 3) make extravagant and often unfounded claims like "superior", "more effective", and "purer". (DHEA, for instance, is a particular landmine of poor quality. I recently suggested that a patient take DHEA; despite consistently taking 50 mg of a specific brand for several months, the blood level of DHEA-S didn't budge one bit--there was likely little or none in the capsule.)

The Fanatic Cook at http://fanaticcook.blogspot.com has posted some very insightful discussions on this issue and the proposed FDA regulations of supplements. They're worth perusing.

I really wish regulation weren't necessary and that the industry could have policed itself. But it clearly has failed and perhaps federal oversight is not such a bad thing, as long as the FDA regulations restrict themselves to oversight over quality and purity and not to efficacy. It's the efficacy regulation that could hogtie innovation in supplement development.

Marketing and truth are not the same

I often remind people: Don't confuse marketing with the truth.

Today, I spent a total of probably an hour and a half dissuading patients that some crazed piece of marketing trying to sell them something was not the same as truth.

I spent approximately 40 minutes alone with a woman who was absolutely convinced that:

--Nattokinase would cure her of all heart disease. It does not. Despite the promising health benefits of natto and vitamin K2 supplementation, nattokinase is a scam with no basis in science nor logic.

--Niacin destroys your liver and homeopathic remedies are superior. Quite simply, homeopathy = quackery. No rational thinking scientist endorses the utter nonsense practiced in this strange and outrageous set of practices that requires you to suspend all reason.

--Sufficient vitamin D is obtainable through a "potent" multivitamin. I know of no multivitamin preparation that even begins to provide the dose of vitamin D that is actually required by adults, nor is it absorbed since these D preparations are powder based.

--Fish oil will poison you with mercury. Accordingly, one brand of fish oil claims to be the only safe form. Those of you following these posts, or the reports of the USDA and FDA, as well as the reports of Consumer Reports and Consumer Lab (www.consumerlab.com) know that, unlike fish itself, there is no mercury in fish oil capsules.

--All coronary atherosclerotic heart disease is caused by heavy metal poisoning. Thus chelation with EDTA represents a cure for heart disease.


People are inundated with marketing that promise extravagant cures, remove need for any medication, make you smarter, sexier, thinner, and on and on.

If you see a TV ad for Ford that says they make the best cars in the U.S., do you immediately run out and put a For Sale sign on your GM car and buy a Ford? No, of course not. You recognize the ad for what it is: marketing. It may be true, but a TV commercial is not enough to convince you.

Then why would an ad promising extraordinary cures for cancer or heart disease convince you that this is true? It should not. Marketing ads should only serve to alert you to the possibility of value or benefit, but should never-- never--stand alone as proof. Take marketing for what it is: marketing of a product or service, not a scientific report, not a factual report, not news.

Marketing is advertising. Period.

More on erectile dysfunction

Several facts on erectile dysfunction and coronary plaque:


If you have erectile dysfunction, there's at least a 50% chance you also have coronary plaque.

If you have coronary plaque by a CT heart scan, there's a 50% chance you have erectile dysfunction.

If you have symptomatic coronary disease (chest pains, breathlessness, prior heart attack), there's a 90% chance you also have erectile dysfunction.


Coronary disease is characterized by a dysfunctional state of the "endothelium", or inner lining of the coronary arteries. Erectile dysfunction is characterized by dysfunction of the endothelium of the penile circulation. Same phenomenon, different territories. (There are other differences, of course, but the two conditions share this fundamental phenomenon.)


If you have any doubts about the physiologic effects of the supplement, l-arginine, just give it a try if you have erectile dysfunction. The erection enhancing effects alone should convince you that a genuine artery-dilating effect is exerted by this very powerful nutritional supplement.

If l-arginine fails by itself to restore full erectile capacity, there are additional strategies, both nutritional and medical, that you can consider.

Our newest Track Your Plaque Special Report on erectile dysfunction is coming out any day now.

High LDL cholesterol--only

As a sequel to my last post, just how often can we blame an isolated high LDL cholesterol as the cause of coronary plaque and a heart scan score?

In other words, how often does someone prove to have only LDL cholesterol as the cause of a heart scan score . . . and nothing else? No low HDL, small LDL, lipoprotein(a), a post-prandial (after-eating) intermediate-density lipoprotein, inflammatory responses, phospholipase A2, high triglycerides, vitamin D deficiency, etc.

Rarely. In fact, I can truly count the number of people who have only LDL cholesterol as their sole cause of coronary atherosclerotic plaque on one hand. It is really an infrequent situation.

Far more commonly, people have 5, 6, 7 or more reasons for coronary plaque.

Thus, the idea that a statin drug to reduce LDL will cure heart disease is completely folly. It does happen--but rarely. I think I've seen it happen twice. Much more commonly, a program that addresses all the causes of coronary plaque yields far superior benefits.

In my view, an effort to identify all the causes is relatively easy, makes far better sense, and provides you much greater assurance that you will succeed in conquering heart disease and removing its evil influence from your life.

Heart disease = statin deficiency

Judging from the conversations I hear from colleagues, what I hear from the media, and drug company advertising, you'd think that heart disease has one cause--a deficiency of statin drugs.

As their thinking goes, if you have coronary disease, you need a statin drug (Lipitor, Zocor, Crestor, pravachol, etc.). If you have progressive coronary disease, you need more statin drug. If you have a heart attack while on a statin drug, you need even more statin drug.

Some "experts" have even proposed that we do away with LDL cholesterol and we just give everybody a statin drug at high doses.

Does this make any sense to you?

Doesn't it make better sense that if someone has progressive heart disease or heart attack while on a statin drug, then target the other causes largely unaffected by a statin drug? Perhaps if LDL cholesterol remains high on the statin drug, then a higher dose is justified. But more often than not, it's not a high LDL on statin drugs that responsible, it's other causes. And there's many of them: low HDL, VLDL, IDL, Lp(a), deficiency of omega-3 fatty acids, inflammatory processes, vitamin D deficiency, among others. (An important exception to this is when the conventional calculated LDL substantially underestimates true LDL as measured by LDL particle number by NMR, apoprotein B, or 'direct' LDL.)

Imagine someone has pneumonia. After 2 weeks of antibiotics, they are only partly better. The solution: a higher dose of the same antibiotic--but never question if it was the right antibiotic in the first place. That's what is going on in heart disease.

The doctors have been brainwashed into believing this $22 billion dollar per year bit of propaganda. The drug companies actively try to recruit the public into believing the same. Don't fall for it.

The statin drugs do indeed have a role. But they are not the complete answer. More of the same when disease progresses makes no sense at all.

Fish oil and mercury

I often get questions about the mercury content in fish oil. I've even had patients come to the office saying their primary care doctor told them to stop fish oil to avoid mercury poisoning.

Manufacturers of fish oil also make claims that this product or that ("super-concentrated", "pharmaceutical grade", "purified", etc.) is purer or less contaminated than competitors' products. The manufacturers of the "drug" Omacor, or prescription fish oil, have added to the confusion by suggesting that their product is the most pure of all, since it is the most concentrated of any fish oil preparation (900 mg EPA+DHA per capsule). They claim that "OMACOR is naturally derived through a unique, patented process that creates a highly concentrated, highly purified prescription medicine. By prescribing OMACOR® (omega-3-acid ethyl esters), a prescription omega-3, your doctor is giving you a concentrated and reliable omega-3. Each OMACOR capsule contains 90% omega-3 acids (84% EPA/DHA*). Nonprescription omega-3 dietary supplements typically contain only 13%-63% EPA/DHA."

How much truth is there in these concerns?

Let's go to the data published by the USDA, FDA, and several independent studies. Let's add to that the independent (and therefore presumably unbiased) analyses provided by Consumer Reports and Consumer Labs (www.consumerlab.com). How much mercury has been found in fish oil supplements?

None.

This is different from the mercury content of whole fish that you eat. Predatory fish that are at the top of the food chain and consume other fish and thereby concentrate organic methyl mercury, the toxic form of mercury. Thus, shark, swordfish, and King mackerel are higher in mercury than sardines, herring, and salmon.

The mercury content of fish oil capsules have little to do with the method of processing and much more with the animal source of oil. Fish oil is generally obtained from sardines, salmon, and cod, all low in mercury. Fish oil capsules are not prepared from swordfish or shark.

Thus, concerns about mercury from fish oil--regardless of brand--are generally unfounded, according to the best information we have. Eating whole fish--now that's another story for another time. But you and I can take our fish oil to reduce triglycerides, VLDL, IDL, small LDL, and heart attack risk without worrying about mercury.

How much omega-3s are enough?

The basic dose we advocate for the Track Your Plaque program is 1200 mg per day of EPA + DHA, the essential omega-3 fatty acids.

1200 mg EPA+DHA is generally obtainable by taking 4 capsules of 1000 mg of fish oil, since the majority of preparations contain 180 mg EPA and 120 mg DHA per capsule.

But how will you know if a higher dose wouldn't be even better?

The principal parameter to look at is triglycerides. If triglycerides remain above 60 mg/dl, we usually consider increasing fish oil.

Another measure that's very important is intermediate-density lipoprotein, or IDL, also called "remnant lipoproteins" on a VAP panel. Persistence of any IDL or remnant lipoproteins is reason to consider more fish oil. Most commonly, if there is some persistence of either, we increase fish oil to 6000 mg per day of a standard preparation, or 1800 mg/day of EPA+DHA.

The only time we see persistence of IDL or remnant lipoproteins with this higher dose is when triglycerides are really high. If starting triglycerides are, for instance, 500 mg/dl, then even this higher dose may be insufficient. This is when more highly concentrated preparations of fish oil may be necessary, occasionally even the prescription form, Omacor. (We currently use Omacor only when high doses of EPA+DHA are required, most because of its outrageous cost. Two capsules per day costs around $120 per month; three capsules per day to provide 1800 mg/day of EPA+DHA costs $180 per month. I think this is outrageous and so we use it only when absolutely necessary.)

You might even argue that a higher dose of 1800 mg EPA+DHA, or 6000 mg of a standard capsule, might be preferable for more assured reduction of heart attack risk--even when triglycerides and IDL are perfectly under control. I wouldn't argue with you. But you won't observe any measurable feedback that tells you that a heightened effect is being obtained. I take that dose myself, in fact, despite the fact that elimination of wheat products and weight loss was sufficient to drop my triglycerides to the target level. I figure it's a small additional effort for added peace of mind.

Repentance for past sins

If you are new to the Track Your Plaque program and would like to jump start your effort, or if you are struggling with losing weight and excess weight is a part of the situation that created your CT heart scan score, then don't forget about fasting.

Fasting is the cessation of eating. However, recall from the Track Your Plaque Special Report, Fasting: Fast Track to Control Plaque at http://www.cureality.com/library/fl_04-012fasting.asp, there are many variations on fasting that permit some intake of healthy foods. (Thus, they are not, in the strict sense, "fasting". Accurate or no, there are variations that may be more palatable or do-able in the real world by real people.)

My personal favorite method to fast is to use a low-sugar, low-fat soy milk such as Light Silk, available at most major grocery stores. This high-protein, low-fat, low-sugar soy milk takes the edge off hunger and provides a minimal quantity of calories. A minimum of 72 hours is required for substantial results. (My one reservation about this brand of soy milk is that the Fanatic Cook claims that the manufacturer, Dean Foods, is a factory farm operation that abuses livestock--a discussion for another day.)

Fasting yields more than weight loss. It refreshes your appreciation for food. It reawakens you to the amount and quality of food you've been putting in your body. Fasting also allows you to recognize just how bad you might feel from the diet you were eating.

You also emerge from a fast with a reduced appetite and a renewed sense of appreciation for food. It makes the discipline of healthy eating a lot easier when you break your fast.

I tell people that fasting is not punishment. It is a form of enlightenment, of re-experiencing food and life. Fasting allows you to "catch up" on all the indiscretions you've been guilty of over the years.

It also provides enormous advantage in gaining control over coronary plaque.

A fanatic for Fanatic Cook

If you haven't already done so, I'd urge you to peruse the wonderfully insightful, sophisticated, and biting commentary provided by the Fanatic Cook Blog at http://fanaticcook.blogspot.com.

She (I assume it's a she) has been discussing the proposed Safe Food Act recently, an effort to address all the dangers in foods that have come to attention lately, like melamine in pet food and E. coli in bagged spinach. Her most recent post is:

Nebraska Farm Bureau Thinks Food Safety Act Bad Idea, the latest in a series of posts exploring this issue.

I'd like to know who the Fanatic Cook is, or "Bix" as she calls herself. (I assume it's a "she" but I don't really know that for a fact.) I've corresponded with her and she prefers to remain anonymous for unspecified reasons. I'd like to know who this person is both for a more secure sense of credibility, as well as I'd simply like to know who can write so intelligently and why. I suspect that she's a professional nutrition scientist or something along those lines, since the level of insight into many scientific issues is quite impressive. Her Blogs will make great material for a book, if compiled and organized. Watch out for this one.

Erectile dysfunction and coronary plaque

Erectile dysfunction (ED), previously known as "impotence," and coronary atherosclerotic plaque go hand in hand.

A recent study in men with advanced coronary disease showed that 93% experienced ED. The participants in the Track Your Plaque program, for the most part, do not have advanced coronary atherosclerosis, but have an earlier form detected by a CT heart scan.

What proportion of men with asymptomatic coronary plaque as measured by a CT heart scan have ED? Around 50%. In other words, it's not a rare occurrence.

The conversation about ED (and even its renaming from impotence) really gained momentum with the development of ED-drugs like Viagra and Cialis. The drugs are reasonably effective and safe. However, you will hear little about all the strategies that can either precede your need for these drugs and/or enhance your response to these drugs if the response is partial. That part of the conversation, of course, doesn't yield loads of drug company revenues.

One of the most helpful and specific nutritional supplements available that can partially restore the nitric oxide-deficiency of ED is l-arginine. L-arginine is the body's source of nitric oxide (NO), the master dilator (relaxing agent) for all arteries of the body. NO dilates penile arteries, it dilates coronary arteries. Lack of NO disables the penile capacity for erection and encourages growth of coronary atherosclerotic plaque. Track Your Plaque Members are already familiar with l-arginine as a facilitator of coronary plaque regression.

We will detail the supplements that you can use safely in your Track Your Plaque program to both enhance erectile function if you suffer ED, as well as impact positively on coronary health, in an upcoming and detailed Special Report on the www.cureality.com website.
The costs of doing drug business?

The costs of doing drug business?

Here's a telling situation.

Liz had been on prescription niacin, Niaspan, 1500 mg per day (3 x 500 mg tablets) for several years to treat her severe small LDL pattern and familial hypertriglyceridemia (triglycerides 500-1000 mg/dl). Because her health insurance had been paying for the "drug," she insisted on taking the prescription form.

A change in insurance, however, meant that the Niaspan was no longer covered. Her pharmacy wanted to charge $227 per month.

Liz came to the office in tears, worried that she was going to have to choke up $227 per month. I reminded her that, as I had told her several years ago, she could easily replace the Niaspan with over-the-counter Sloniacin or Enduracin. Both release niacin over approximately 6 hours, just like Niaspan.

Here are the prices I've seen with Sloniacin, 100 tablets of 500 mg:

Walgreens: $15.99
Walmart: $12.99
Costco: $8.99

So the most expensive source, Walgreens, would cost Liz just under $15.99 per month to take 1500 mg per day.

$15.99 versus $227.00 per month for preparations that are highly similar. Hmmmmmm.

I wonder what the $211.01 extra per month goes towards? Admittedly, Abbott Labs, the current company selling Niaspan (after Abbott acquired Kos), has invested in a few clinical trials, such as ARBITER-HALTS6. But does supporting research justify this much difference, a difference that amounts to $2532 over a year? If just 100,000 patients are prescribed Niaspan at this dose (a typical dose), this generates $253 million.

Is the cost of developing and marketing a supplement-turned-drug that great? Is this justifiable? Is it any wonder that our health insurance premiums continue to balloon?

I use Sloniacin and Enduracin almost exclusively.

Comments (28) -

  • Brent

    1/5/2011 11:12:42 PM |

    Is Sloniacin safe to use without a doctors supervision?  (I have low LDL, but it is almost all "B" particles. Triglycerides are pretty close to target range.)  What dose do you usually start patients out at?

  • Anonymous

    1/6/2011 12:01:03 AM |

    Could someone please explain how Abbot and Glaxo Smith Kline obtained patents for Niaspan and Lovaza? And why doctors prescribe these when essentially the same things are available over the counter?

  • Tx CHL Instructor

    1/6/2011 12:27:43 AM |

    I wrote up an article on my blog illustrating my experience with the healthcare industry back when I was trying to earn a living as an insurance peddler. See http://chl-tx.com/2009/09/how-to-get-the-best-deal-on-health-care/

  • Basil

    1/6/2011 12:56:24 AM |

    I hate how the drug companies cry about how much they spend on research.  Most research is funded by government grants with the bill footed by the taxpayer.  Then they make us pay for it again when we purchase the drugs.  What a scam.

  • terrence

    1/6/2011 1:01:59 AM |

    I paid a lot less than $5 for 100 tabs of house brand Niacin at Safeway(aka Vons, Randalls).

    I took 1,500 mg for several months. I got a warm flush for 15 to 20 minutes that was bad at all. My LDL went way down after a few months, and HDL went up a bit.

    Cheap is good, if it works.

  • terrence

    1/6/2011 1:14:30 AM |

    Typos, typos, typos...

    I paid a lot less than $5 for 100 tabs of [500 mg] house brand Niacin at Safeway(aka Vons, Randalls).

    I took 1,500 mg [a day] for several months. I got a warm flush for 15 to 20 minutes that was [NOT] bad at all. My LDL went way down after a few months, and HDL went up a bit.

    Cheap is good, if it works.

  • Travis Culp

    1/6/2011 1:52:42 AM |

    At least she didn't insist on the name-brand like that Lovaza guy.

  • Anonymous

    1/6/2011 2:59:53 AM |

    Be careful with switching.

    Be careful with liver effects.

    http://cholesterol.emedtv.com/niacin/types-of-niacin-p2.html

  • Anonymous

    1/6/2011 3:17:22 AM |

    I was trying niacin supplements, and I started out with 500 mg each morning, which initially caused uncomfortable flushing. The flush got less uncomfortable over the next few weeks, and then I added another 500 mg at bedtime. The flush came back, but gradually got less uncomfortable over the next week, and then BAM!!! I suddenly started getting the worst headaches I have ever had. A couple of ibuprofen would make the headache bearable, and I did not immediately associate the headaches with the niacin, since the onset of the headaches was several days after I upped the dose to a gram a day. The headaches persisted, and after the 3rd day of those horrible headaches, I decided it had to be something I changed recently, and the niacin was the only thing that made sense.

    So I omitted the niacin complete the next day. No headache. Ok, since I had taken 500mg for several weeks without getting headaches, I took 500mg the following day -- BAD HEADACHE. I divided the tablets using a pill-splitter to get a 250mg dose -- BAD HEADACHE. Nuts. I cut it out completely, no headache.

    I get about 50mg of niacin in a multi-B-vitamin tablet without headache, but I wonder if I have somehow sensitized myself to niacin, which would mean that I won't be able to get the cholesterol effects I was after.

    I'm also wondering if maybe there is some interaction between the niacin and some other vitamin or mineral (or food). I haven't taken any of the 500mg pills for over a week (no headaches at all during that time), and I may try 250mg tomorrow morning (and carry a dose of ibuprofen with me just in case). But I'm interested in seeing if anyone else has had a similar experience.

  • Anonymous

    1/6/2011 6:13:12 AM |

    Niacin can do wonders. In the distant past I used it to control and stop knee pain which had troubled me for several years. A true life saver given what NSAIDs were doing to the stomach.
    In time, it apparently caused the heart
    to start skipping beats. In rare persons, it may cause myopathy of the heart muscle; therefore, I stopped it.
    And when higher than 100 mgs per day
    are reintroduced the heart starts to
    skip beats again even years later.
    I am not saying don't use it but it can have side effects so be alert. There are
    alternatives to niacin if it doesn't fill the bill. For example pantethine and fenugreek seed for blood lipids and fish oil, boswellia, and MSM/DMSO2/dimethylsulfone for joint pain.


    Trig

  • Coach Rollie (FX)

    1/6/2011 6:54:28 AM |

    Is there a big difference between big drug companies and street drug dealers.  Hmm.

  • Anonymous

    1/6/2011 1:27:21 PM |

    Be careful of timed release niacin...can cause jaundice.

    I think consumers in the EU recently lost the right to use herbs/supplements (?)...coming to the US soon?

    Very important that we protect drug company profits...since main street is going down the tubes?  Wink

  • Dr. William Davis

    1/6/2011 3:34:14 PM |

    Brent--

    I believe that, ideally, any form of niacin is best taken under supervision.

    That said, it is sad to realize how few healthcare practitioners actually know or care about using niacin. The only reason there is some awareness is because of, of course, drug industry marketing of Niaspan.

  • Kent

    1/6/2011 6:04:20 PM |

    Thanks Doc,

    I am curious as to the release time you have given on Sloniacin. Is that release time you quoted from the manufacturer?  

    From what I gathered there were 3 types of Niacin, imediate release (IR), extended release (ER), and slow release (SR). With Niaspan and Enduracin being in the (ER)camp and Sloniacin being in the (SR) camp, being a bit harsher on the liver.

  • polacekt

    1/6/2011 7:09:04 PM |

    Kent,
    There is no clinical differentiation between SR and ER.

    Kos funded a dissolution study comparing Niaspan and 7 non-prescription niacin products labeled as SR or Timed-Release, including Endur-acin and Slo-Niacin. The results were graphed and compared, and Niaspan was the slowest, with Endur-acin virtually identical.  slo-niacin was a bit quicker.

    Kos and Abbott have gone to great lengths to perpetuate the myth that the Niaspan dissolution is unique, that non-prescription products are longer acting, and therefore more hepatotoxic.  The reality is if you dose them once daily like Niapsan, you have the same kinetics and dynamics. Dosing twice daily makes them easier to tolerate, but means that one must be more careful in determining you max dose before liver enzyme elevation occurs - hence physician monitoring especially during the dose escalation period.  For many ER niacin users dosing twice daily, 1500mg is a total max daily dose.  With respect to results (dynamics) the twice daily regimen increases the LDL response, but lowers the HDL response somewhat as compared to ER once daily.
    So how you take it may also depend on your lipid goals and what else you are taking.  
    I can tell you first-hand, that the majority of the medical community is not aware of this published dissolution data, or the pharmacodynamic differences in dosing regimen.
    Any one who receives push-back from their physician should provide them with the article, "Dissolution Profiles of Extended Release Niacin...." American Journal of Health-System Pharmacy, 2006

  • Anonymous

    1/6/2011 10:46:53 PM |

    Good info. Does anyone know of a doctor in Sioux Falls, SD that is up to date on this and other treatments/tests that Dr. Davis discusses on this blog? My current GP doc has no idea on much of this.

  • polacekt

    1/6/2011 11:01:38 PM |

    your best bet is to find a certified lipidologist.  go to learnyourlipids.com and put your city and zip in.  it will tell you there are several near you.

  • Anonymous

    1/6/2011 11:14:26 PM |

    Here is a start to self education but it is best to Pubmed all of these issues; just enter Niacin and then start reading. Sometimes all you need is to read "conclusion." Very well organized. pubmed.org

    I read it for the fun of it. Is pubmed everything we need to make informed choices? Nope, not at all, but like I said, it is a good solid start.

    Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products.
    Poon IO, Chow DS, Liang D.

    College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX 77004, USA.

    Abstract
    PURPOSE: The dissolution profiles of nonprescription extended-release niacin and inositol niacinate products were studied using the prescription extended-release niacin, Niaspan, as a reference.

    METHODS: Seven nonprescription extended-release and 12 nonprescription inositol niacinate products were collected from community and online pharmacies in the United States. Extended-release Niaspan was used as a reference. Dissolution profiles were examined by the United States Pharmacopoeia dissolution test, using a paddle method. Release samples were removed every 30 minutes for up to 240 minutes. Niacin was quantified by high-performance liquid chromatography.

    RESULTS: Ten out of the 12 inositol niacinate products were capsules and 6 of the 7 extended-release formulations were tablets. During the initial 30-minute dissolution study of inositol niacinate products, free niacin was released to various degrees. One product achieved fast dissolution, with >30% cumulative release of niacin. The cumulative percentage of niacin released at 240 minutes of all inositol niacinate products was statistically different (p < 0.0001). The majority of these products reached a plateau of releasing niacin in one to two hours, which was maintained until the end of the study. Six out of the seven extended-release niacin products had extended-release profiles. Five products showed a statistically higher dissolution rate (p < 0.05) than that of Niaspan.

    CONCLUSION: Significant variations in dissolution profiles were noted among the 7 nonprescription extended-release and 12 nonprescription inositol niacinate products in vitro, and their dissolution rates were not comparable to that of the prescription extended-release niacin. Further studies are warranted to correlate such dissolution data with their in vivo efficacy.

  • Jason A.

    1/7/2011 3:22:52 AM |

    Alot I read online says to use IR niacin to avoid liver toxicity, which can occur with slow release. Any thoughts on the issue? Any brand recommendation for IR niacin? Thank you.

  • Samual

    1/7/2011 5:43:08 AM |

    Its a great Blog. Medical tourism, which is the practice of traveling from one place to another for medical care, is no longer limited to patients seeking conventional treatments and thus leads to Pancreatic cancer treatment India.

  • Anonymous

    1/7/2011 12:49:10 PM |

    I bought a bottle of 1,000 tabs of 500 mg IR Niacin, Rugby brand, for about $29, shipped. I'm at 2 a day with modest and very manageable flushing most of the time. I've only been at the full dose for about two months so I don't yet know the results but I'm due for preliminary bloodwork soon. IR niacin is supposed to be the least hepatotoxic and most effective for most lipid parameters (LDL excepted). It is certainly the cheapest.

    For those going this route, don't jump in with 500 mg a day right off. Get a bottle of 100 mg and work up slowly. I started with 50 mg and went up 50 mg every two weeks.

    If it turns out I need 1,500 a day and the flushing becomes unmanageable I might go to Slo-Niacin.

  • Anonymous

    1/8/2011 6:32:59 AM |

    Dr. Davis, can you please explain how the money for insurance premiums goes to drug companies?

  • polacekt

    1/8/2011 6:53:17 AM |

    Anonymous, Why are you anonymous?

  • Stargazey

    1/8/2011 3:21:48 PM |

    Is the cost of developing and marketing a supplement-turned-drug that great?

    Yes. Have you ever performed a drug trial? The paperwork is mind-boggling. It costs millions to create a protocol, get it approved, recruit sites, recruit patients, monitor sites, collect data, follow up adverse reactions, compile the data and resolve queries about how the data was entered.

    And if the FDA has significant objections or questions about what you've done, you get to do another trial to resolve those issues.

    All of that has to happen before the first ad goes on paper. I'm not saying the FDA's procedure is wrong, but it costs mega-millions to do it.

  • Anonymous

    1/8/2011 11:43:20 PM |

    Great post, Dr. Davis.  My doctor strongly advised me to take Niaspan to lower my triglyceride levels which were 240.  I asked her about Slo Niacin because it was so much less expensive, and she recommended against it b/c it's not regulated and you don't know how much of the medicine you are really getting in OTC form.  So I took the Niaspan and 6300 mg fish oil for 3 months and it did lower my triglycerides to 112.  I also cut out bread and most other bad carbs - pizza, potatoes, sweets other than dark chocolate.

  • Anonymous

    1/9/2011 8:00:56 AM |

    There's a kernel of truth to the concern that OTC/supplement products are not as well regulated as pharmaceuticals, but it's a concern that's WAY overblown by the medical profession and the drug companies who train most of them these days.

    For one thing, the pharm drugs are not as well regulated as many assume. There's not an FDA inspector running or overseeing tests on every batch that goes in a bottle. Plenty of problems come to light still despite staggering fines levied by the FDA.

    Second, the supplement industry is no longer run by hippies stuffing capsules in a garage in Northern California. It is a big-money industry with plenty of good chemists and equipment and manufacturing standards both voluntary and regulatory. It can take a bit of research, but there are plenty of good products out there. For many things like Niacin, the OTC versions are available from generic drug producers with very long track records of quality.

    Lastly, for most applications like lipids, the proof is in the numbers. If we're talking about digoxin, yes, it makes a huge difference if delivery isn't controlled down to the microgram. With niacin, honestly, what difference does it make if you get 520 mg one day and 485 the next? None. If the product is fairly tight, you'll get consistent results with your lipid numbers.

  • Simply Natural FX

    1/10/2011 11:42:29 AM |

    I was taught that for the best results you take the full spectrum of vitamin B's, never separate them. If you take only one you create an imbalance that causes problems with the levels of the remaining B's.
    My question is why the obsession with lipids, target ranges and having good numbers? The only true test is in how you are doing. Why the extra strain, is this to be healthy or avoid getting sick? There is a difference. What is the true goal here?
    The whole cholesterol thing was never a proven problem, but an assumption that has been used to make billions of dollars trying to get the levels down, with no evidence that doing so is in any way helpful, but the means to lowering the count has proven harmful. I see worrying about reaching certain levels, as unneeded stress, which is bad in and of itself.
    If it's toxic to take too much, why strive for higher levels when getting the flush is a sign you've got enough in your system already?
    Cost aside, getting the right kind of vitamin is more important, the natural vs the artificial, the best absorption rate.

    Life is balance, the body strives for it, knows how to get it, just needs the materials to do it best for you.

  • Anonymous

    1/27/2011 1:22:28 AM |

    It's an absolute shame that the FDA is going after Sloniacin for speaking the truth.
    http://bit.ly/eebWnM

    Sloniacin has to remove all references to cholesterol, lipids, statins etc. from their website, brochures and product label. Sloniacin has already shut down their website.

    I don't need this product, but I feel for the folks on fixed incomes who won't know about this cheap alternative to Niaspan.

    I want to scream.

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