The battle for natural hormones

The battle for preservation of availability of compounded natural hormones goes on.

It started with pharmaceutical manufacturer, Wyeth, who petitioned the FDA to disallow the mixing of pharmaceuticals, especially natural human hormones, by specially trained pharmacists at what are called "compounding pharmacies." These are pharmacies that have special equipment and where trained pharmacists can mix up specific preparations for dispensing. These are available by prescription.

For instance, I have been prescribing natural human testosterone and progesterone for nearly 10 years. I have found service to be excellent, with lots of learning materials provided to patients by the pharmacy. The pharmacists I've spoken to have been courteous and knowledgeable. Compounded hormones are also shockingly less expensive. While a testosterone patch from a pharmaceutical company costs around $4.00 per day, the same quantity of testosterone cream formulated by a compouding pharmacy costs around $0.50 per day--87.5% less.

Wyeth hides behind a smoke screen of concern over quality. But the price differences tells the entire story: they want to eliminate the inexpensive competition and hold us all hostage to the far more expensive, often inferior products that they produce. They'd sooner force a woman to use horse-derived Premarin than to allow her access to human estrogens and progesterone.

To me, this is an outrageous affront to our freedom of choice, both as consumers as well as a physician. If you feel as strongly as I do about opposing the unfair and bullying ways of Wyeth Pharmaceuticals and the FDA, the P2C2 association of compounding pharmacists makes writing a letter to your Senator easy by going to

http://iacprx.convio.net/site/PageServer?pagename=P2C2

Just enter your info and personalize the comments, and the e-mails will be generated for you.

Lipitor and memory

At first, I was skeptical. A book from a nutty author and physician named Duane Graveline kept on coming up in conversations with patients. His book, Lipitor: Thief of Memory , details his personal experience with dramatic changes in memory and thought while taking Lipitor.



Now this is a drug that I've seen used thousands of times. But I've now seen about a dozen people who have had distinct struggles with memory and clarity of thinking while taking Lipitor. Most took doses of 40 mg per day or more, though an occasional person takes as little as 10 mg. The association seems to be undeniable, since it improves after two weeks off the drug, recurs when resumed. Just today, I saw two people where this effect may be an issue.

Curiously, I've not seen it with any other statin agent. Unfortunately, uncovering any scientific data on the issue is a hopeless quest. Either it's very uncommon or, worse, the data has been suppressed.

Any way, I believe that Dr. Graveline was right: Lipitor, in a small number of people, does indeed seem to exert real detrimental effects on the mind.

If you take Lipitor, should you stop it in fear of long-term effects on your mental capacity? I think it's premature to toss the drug out based on this relatively uncommon relationship. This particular effect is likely to be idiosyncratic, i.e., peculiar to an occasional person but does not seem to apply to the majority, probably by some quirk of metabolism or penetrability of the barrier between the blood and nervous system tissue.

If, however, you feel that your thinking and memory have deteriorated on the drug, please speak to your doctor.

EKG's and heart disease


How helpful are EKG's for detecting hidden heart disease?

I pose this question because several patients asked this question just this week. It's also a frequent point of confusion and misperception.

Your EKG is nothing more than an expression of the surface electrical activity emitted by heart muscle activity. Multiple (12) leads are attached to the body simply to provide various "views" of this electical activity. EKG, or sometimes "ECG", is short for "electrocardiogram".

What modifies this surface electrical activity? Anything that modifies the electrical activity within the heart itself, or interferes with the detection of the activity. An old heart attack modifies the patterns of electrical conduction in the heart and that can change your EKG. An ongoing heart heart attack likewise. High blood pressure commonly creates changes in the EKG, as does lung disease. A bellyache can change your EKG, as can a stroke. (These non-heart-related phenomena probably are often due to changes in autonomic, or "automatic," nervous system activity.) The heart generates electrical activity in a predictable sequence that generates the heart beat, or "rhythm". EKG's are useful for monitoring heart rhythm, also.

Does having plaque in your coronary arteries have any effect on the EKG? None whatsoever, unless plaque rupture caused heart attack or is about to cause heart attack. So, you can have a horrendous CT heart scan score of, say, 3000, yet maintain a perfectly normal EKG, as long as the heart muscle is normal.

Then why bother with these iffy tests? They are indeed useful to diagnose the cause of active symptoms. For instance, go to the ER with chest pain and an EKG could show changes suggesting that the chest pain is a heart attack. EKG's are also useful for future comparison. Any change in EKG can suggest certain things, like new heart rhythm disturbances unrelated to coronary plaque.

Think of your EKG as just like buying a used car. Say I'm trying to sell you my 1999 Buick Century. It looks pretty good from the outside and I tell you that it has 70,000 miles and runs well. You ask to open the hood, look in the interior and take it out for a drive. I tell you no, you can't do that.

Would you buy the car? Of course you wouldn't. You were permitted only a very superficial examination of the car. You have no idea what's going on inside. Just because the paint job looks brand new doesn't mean the engine and transmission are good.

The same with your EKG: It's a superficial look at one aspect of this used car called your heart. If the EKG is normal, that's good, just like a good exterior on the Buick. But you cannot assume that the heart is otherwise normal.

View the EKG as a simple, superficial test that can only provide minimal reassurance, no matter how often you have it done.

A new Track Your Plaque record

Neal, a 40-year old school principal, and his young wife were terrified on learning of his CT heart scan score of 339, a concerningly high score for any age, particularly age 40.

To make matters worse, all of Neal's plaque was located in the critical left mainstem coronary artery, the shared stem of two of the three coronary arteries. A heart attack in this location is instantly fatal.

So, it was especially gratifying that Neal has set the Track Your Plaque record for largest magnitude of plaque reversal: 51% in his first year.

Studies that show a reduction in heart attack make the news. They talk about 1, 2, up to 6% regression, all achieved with high doses of statin drugs. Yet we are seeing huge, extraordinary quantities of heart disease reversal that haven't yet made headlines, amounts that far exceed those featured in the news. We should be encouraged by experiences like Neal's.

Watch for the upcoming Track Your Plaque newsletter for more details on Neal's story--how he came to the program, how he accomplished this huge effect, and why his experience was such a success. If you haven't yet subscribed, go to the www.cureality.com homepage and click on the upper right hand corner.

The Plavix Scam

Periodically, I'll see a flurry of TV ads for Plavix. It comes with a polished computer-animated cartoon that shows how platelets clump and form a blood clot, causing heart attack.

Imagine there's a pile of oil-soaked rags in a corner of your garage. I come by and tell you to get a good fire extinguisher to keep next to the rag pile in case they spontaneously ignite.

Does that make sense to you?

Wouldn't it be better to get rid of the oily rags and forget about the fire extinguisher?

Plavix is the fire extinguisher. The oil rags are your coronary plaque. The solution is to gain control over plaque behavior. Unfortunately, the TV ads (intentionally, I suspect) give the impression that blood clots just form out of the blue for no reason. Of course that's not true. It requires active, growing, inflamed atheroslcerotic plaque that ruptures, uncovering the "angry" and platelet-adhering material underneath the thin covering or endothelial lining.

Urging everybody to take Plavix is absurd. The TV ads urge many people who have no business taking the drug to take it. There are, without a doubt, groups of people who are better off taking Plavix and aspirin: people who are in the midst of heart attack, people who have unstable plaque, people with recent stents or bypass. Perhaps people at high risk for plaque rupture, e.g., extensive coronary plaque that has continued to grow.

These tactics are consistent with the experiences I've had with the sales representatives from the company (when I used to actually talk to sales reps; my office is now barred from them). The reps very aggressively would urge me to consider having everyone take Plavix. No kidding.


For us, i.e., for people who just have a heart scan score but interested in engaging in a powerful program of prevention and reversal, Plavix rarely provides any advantage. The answer is, just like our oily rag analogy, control the plaque, not put out the fire.

Lipoprotein(a) and small LDL

You won't find a lot of scientific validation for this, but it is my firm impression that small LDL, by some crazy means, has the capacity to "turn on" or "turn off" lipoprotein(a), Lp(a).

Recall that Lp(a) is a specific genetic trait, passed to us (if you have it) by mother or father. It falsely elevates LDL cholesterol and escalates heart disease risk more than just about any other known abnormality.

A frequent hint that Lp(a) might be present is a comment I hear often from patients: "My doctor said statin cholesterol drugs don't work for me. I tried them all and my cholesterol won't go down." Or, the result was substantially less than expected. That's because, when Lp(a) is lurking in your cholesterol value, it is unaffected by the statins.

It's been my in-the-trenches observation that, the more fully expressed the small LDL pattern becomes, the worse the Lp(a) behaves. In other words, if small LDL is suppressed effectively, Lp(a) doesn't seem to carry the same dangers as in someone who has plenty of small LDL. I don't know why this is. (I expect that the answer will come from someone like Dr. Marcovina at Stanford, who is at the forefront of Lp(a) structural research. Lp(a) is a complex molecule with several components. How and why it interacts with other particles remains a mystery.)

There are a little bit of data to confirm this. The Quebec Cardiovascular Study has presented some data to this effect, that the combination of small LDL particles and Lp(a) are a particularly lethal combination. We are trying to correlate our data from a CT heart score perspective to discern any statistical relationships.

This raises a very important therapeutic issue if you have Lp(a): the worst thing you can do if you have Lp(a) is become overweight. Excess abdominal fat is a huge trigger to create small LDL particles. Even though being overweight itself has no effect on the measured level of Lp(a), it activates small LDL which, in turn, throws gasoline on the Lp(a) fire.

If you have Lp(a), stay skinny.

Optimal medical therapy

I was re-reading some of the details behind the recently announced COURAGE Trial comparing angioplasty/stent in 1100 people compared to "optimal" medical therapy in another 1100. You'll recall that no difference was found.

In particular, over approximately 5 years, 20% of participants in each group died, experienced heart attacks, or strokes. Of those treated with "timal" medical therapy, 32% ended up getting a procedure like stents or bypass anyway due to deteriorating symptoms.

What is "optimal" medical therapy? I bring this up again because the study investigators in COURAGE, as well as in similar trials, say this with a straight face. Optimal medical therapy means aspirin and/or Plavix (the anti-platelet, aspirin-like blood thinner); "aggressive" statin drug therapy to reduce LDL cholesterol to 60-85 mg/dl; and "anti-ischemic" therapy (that reduces angina and the phenomena of poor coronary blood flow) using nitroglycerin preparations, beta blockers, and other drugs.

I do give credit to the investigators for having the courage to perform this trial in a world hell bent on doing procedures and still reporting the neutral outcome. But the notion of "optimal" medical therapy begs for comment.

Indeed, this is regarded as optimal by most practitioners. Some would even argue excessive, based on the low LDL target achieved. Would you be satisfied with a 20% likelihood of heart attack, stroke, or death or 5 years, a 1 in 5 roll of the dice? I would not. Recall that we aim for near-total elimination of risk.

What could have been further "optimized"? Plenty. For instance:

--What is the real LDL, not the fabricated, calculated LDL? The two can be commonly 100 mg/dl different.

--How about raising HDL to 60 mgd/?

--What about reducing the proportion of small LDL particles? After all, small LDL is the number one cause of heart disease in the U.S., not high LDL.

--What is Lp(a)? If you treat LDL with a statin drug, Lp(a) is unaffected and continues to trigger huge plaque growth. You will fail if this is not identified and corrected.

--What is vitamin D3? One of the most powerful facilitators of plaque reversal I know of.

--What are triglycerides? Triglycerides create hidden particles in the blood like intermediate-density lipoprotein, potent triggers for coronary plaque growth. Speaking of intermediate-density lipoprotein, that's another very important pattern to identify, the after-eating persistence of dietary fats.

--Why aren't they taking fish oil? With a 28% reduction in heart attack and 45% reduction in sudden death from heart attack, this alone would have halved the number of "events" in the "optimal" medical treatment group.

Of course, there's more. But the idea that aspirin, statins, and anti-ischemic therapy is somehow optimal is silly and sad at the same time. But that's the bias. The COURAGE Trial does represent a step forward, a step away from the "stent everyone and everything" mentality that motivates my colleagues, aided and abetted by their co-conspirators, the hospitals. But you and I know better. "Optimal" medical therapy, in truth, can mean a far better approach that can dramatically reduce, perhaps eliminate, risks for events like heart attack. The conventional "optimal" medical therapy will suffice only if you're content with a 20% likelihood of heart attack, death or stroke, or a 32% likelihood of an urgent procedure in your future.

Niacin, postprandial patterns

For a detailed report on the very important postprandial (after eating) patterns that contribute hugely to heart disease risk, read my recent article in Life Extension Magazine, available (no cost) at:

Uncovering a Hidden Source of Cardiovascular Disease Risk
at http://www.lef.org/magazine/mag2007/mar2007_report_heart_01.htm


For a report on using niacin to reduce risk of heart disease, see another report in the same issue of Life Extension:

Ask the Doctor: Using Niacin to Improve Cardiovascular Health
at
http://www.lef.org/magazine/mag2007/mar2007_atd_01.htm.

Also, keep your eyes open for a lengthy report focused exclusively on the Track Your Plaque program in an upcoming issue of Life Extension. I'll provide links in this Blog when it comes out.

What's better than fish oil?

One of the recent questions on our Track Your Plaque Forum related to what to do about a triglyceride level of 101 mg/dl while on fish oil.

Recall that, contary to conventional thinking like that articulated in the ATP-III cholesterol treatment guidelines, we aim to reduce triglycerides to 60 mg/dl or less. This is important to suppress the formation of abnormal triglyceride-containing lipoprotein particles, especially small LDL, reduced HDL, lack of healthy large HDL, VLDL. ATP-III advises a level of 150 mg/dl or less. Unfortunately, triglyceride levels this high guarantee appearance of all these undesirable particles and an increasing heart scan score.

What's better than 4000 mg of fish oil for its 1200 mg of EPA and DHA (omega-3 fatty acids)? More fish oil. In other words, the 4000 mg fish oil providing 1200 mg EPA + DHA is our minimum. A simple increase to 6000 mg to provide 1800 mg EPA + DHA is usually all that is necessary to reduce triglycerides and put a halt to the cascade of abnormal lipoprotein particles that trigger plaque growth. Occasionally, a somewhat higher dose may be required. Doses are best divided into two, with meals (e.g., three capsules twice a day).

Another important issue: An over-reliance on wheat products can also increase triglycerides. This includes any flour product like breads (regardless of whether it's white, whole wheat, or whole grain--they all raise triglycerides), pretzels, bagels, breakfast cereals, and pasta. A dramatic reduction in wheat-containing products will reduce triglycerides substantially, help you reduce your abdominal fat, reduce blood pressure, raise HDL and reduce small LDL, clear your mind, provide more energy, avoid afternoon "fogginess" . . . Huge benefits.

Valve disease and vitamin D

There are two common forms of heart valve disease: aortic valve stenosis (stiffness) and insufficiency (leakiness), and mitral anular calcification.

Both valve issues are regarded as evidence of senescence, or aging--the older you are, the more likely you will have one or both. Both conditions involve progressive calcium deposition and, to some degree, cholesterol deposition. They might be regarded as phenomena of "wear and tear" just like hip arthritis.

There are no known therapies to stall or stop the development of mitral anular calcification. However, several attempts have been made over the years to identify treatments that can slow or stop the progression of aortic valve disease, which is becoming increasingly common and is addressed by surgical valve replacement when severe. The most recent trials have examined whether high-dose Lipitor (80 mg) has any effect (it did not) and high dose Crestor (40 mg), which slowed but did not stop the deterioration of stiff valves.

It's been my suspicion that vitamins D and K2 may play a crucial factor in valve health. After all, vitamin D is the master controller of calcium deposition. Preliminary data also suggest that people who are intentionally made vitamin K deficient with the drug, Coumadin, develop twice the calcium deposition on aortic valves that non-Coumadin takers develop.

I saw a patient Friday, Marianne. In addition to a moderate heart scan score of 379 at age 71, Marianne had a leaky (insufficient) aortic valve. By an echocardiogram 18 months ago, the valve was moderately leaky. I put Marianne on vitamin D, 4000 units, to raise her blood level to 50 ng/ml.

Last week, I asked Marianne to have another echocardiogram. This time, no leakiness whatsoever--none. I have never seen this happen before. Although Marianne is only one example and we don't want to extrapolate too far from the experience of one person, it's hard not to attribute this phenomenal response to vitamin D supplementation.

I wonder what would have happened if we had added vitamin K2, as well?

Anyway, just another potential wonderful effect of vitamin D restoration.
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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