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Treating Statistical Markers of Disease Is Not the Same as Treating Disease Itself

This trial treatment with niacin offers disturbing results in the fight to prevent strokes and heart attacks.

by
Theodore Dalrymple

Bio

August 5, 2014 - 8:00 am
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What stands to reason is not always borne out by facts, for reality is often refractory to human wishes. There was a good illustration of this unfortunate principle in a recent edition of the New England Journal of Medicine.

It has long been known that low concentrations of high-density lipoproteins (HDL) and high concentrations of low-density lipoproteins (LDL) are associated, in a more or less linear fashion, with cardiovascular disease such as strokes and heart attacks. It would seem to stand to reason, therefore, that raising the HDL and lowering the LDL would lead to fewer cardiovascular “events,” as strokes and heart attacks are called.

One way to achieve this wished-for biochemical change is to treat patients at risk of such events with niacin, a B vitamin, in addition to the statins that they are already taking. The largest placebo-controlled trial of niacin ever undertaken, with 25,673 patients who had already had a stroke or heart attack, has shown that the addition of niacin, though it does indeed increase HDL and decrease LDL, has no effect on the rate of heart attack or stroke. Worse still, it gave rise to serious side effects, such as worsening of diabetes and unpleasant gastrointestinal, musculoskeletal and dermatological effects. One of the most unexpected findings of the trial was the excess of infections in people treated by niacin. If anything, the overall death rate in the niacin-treated group was higher than that in the placebo control group, though the difference was not statistically significant (which is not quite the same thing as saying that it was not real). The patients were followed up, on average, for nearly four years and at no time was treatment with niacin superior to that with placebo. 

All Comments   (14)
All Comments   (14)
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Anyone on statins increases their risk for side-effects. Therefore, niacin, which may be fine for someone 'not' on statins, may become problematic in high doses due to metabolic interaction with another drug, i.e., statins. :-)
11 weeks ago
11 weeks ago Link To Comment
I have taken high dose slo-niacin for about 8 years along with fish oil. My triglycerides were very high and have come down because of this. I also had a skin rash for most of my life which also went away. With recent concerns about fish oil and niacin I have scaled back on both. My skin rash is coming back and I don't know about the trigs until I have a blood test. "Ask your doctor." LOL.
11 weeks ago
11 weeks ago Link To Comment
Everyone wants free stuff. It's normal. I get a gated tomography every few years, and I pay out-of-pocket. So what does it tell me? Whether or not to be scared and whether or not I may need to change my lifestyle, and whether or not I need to see a doctor. Stents and CABGs only make you feel better; they don't extend your life. So they say. Things change every year.

Niacin does a lot of other good things beside affect cholesterol. And it can also inflame your liver. And statins can cause liver problems, too. And statins don't even work to fix cholesterol numbers -- but they do sooooo many other good things that you really should take them, and so they're mandatory in Great Britain (so to speak).

I do take vitamins (mostly Vit-C and L-lysine), and they've helped my numbers, but then again I quit a doctor because he insisted that I had to have the numbers HE said I should have. I refused Lipitor and he typed into my record that I was non-compliant. I brought my numbers down on my own without the Lipitor he gave me. (And I think he himself in on niacin.)

There are very few things that actually work. And fewer still that always work. And fewer still that don't have risks. And if I really had the answer and told you if you, oh, go on a macrobiotic diet, don't drink and don't have sex and chew each bite 600 times and you'd live to be a hundred, how many of you would do it for the rest of your life. None of you.

Life is hard, and then you die; and after that the judgment. Thank God Jesus can forgive our sins, and help us in this life. This is the key to well-being today and forever.
11 weeks ago
11 weeks ago Link To Comment
Medical studies can be broken down into two broad catagories, disease oriented studies and POEMs. Disease oridented studies evaluate suregate endpoints and presume that changes in the clinical outcomes will mirror the changes in the markers. This is the case with cholesterol, hscrp, etc. POEMs are 'Patient Oriented Evidence that Matters'. Rather than tracking hscrp levels and reporting that as an endpoint of the study, POEMs will look at the effect of an intervention on indicees such as death, MI, renal failure, stroke etc. Sometimes there is a partial coorelation with an endpoint such as cholesterol towards heart disease, but too much concentration on that can detract someone from interventions that have been shown to reduce disease (vigorous exercise).
12 weeks ago
12 weeks ago Link To Comment
I've been thinking about "markers" lately. Dad had a bypass operation. Another family member died suddenly, and relatively young, of a massive heart attack. And I ain't feelin' that great myself...

My question is, why do we have to rely on statistics when a couple of tests would tell us for sure? I want to know what's going on with my heart. My cholesterol numbers only tell me what, statistically, might be going on with my heart. They don't tell me the actual state of my coronary arteries.

Here's some statistics: I'm over fifty, I'm overweight, I have high blood pressure, my dad has heart problems, his dad had heart problems. I say screw the cholesterol tests. How about a yearly echocardiogram? How about some x-rays or CAT scans w. contrast agents? How about ANYTHING other than guessing?

Why are my colon and my prostate considered fair game while my heart is evidently off limits? They'll yell at me if I wait until I can't pee or I'm pooping blood. "You should have gotten tested!" But if I die of a heart attack, nobody asks why I foolishly delayed having a cardiact cath until it was too late. The subject never came up. It didn't seem to be an option. I was supposed to eat better, get some exercise, and leave the rest to Mother Nature.

I get tired of doctors speculating about what's going on inside my body, as if the body were still a great mystery. They might as well be examining the color of my urine for all they REALLY know about me.

I'm not a patient - I'm a statistic.
12 weeks ago
12 weeks ago Link To Comment
So don't speculate, get actual pictures and 3d images of your heart and coronary vessels, along with your upper lungs. Year before last I went to my local imaging lab and arranged to have a coronary CTA done with a 128 slice machine after taking my primary care physician into giving me a prescription. The imaging is sharp enough for diagnostic purposes and it's not very expensive, compared to a heart attack. I paid $750 and later found out my insurance would have covered it at $530. I have the images, the videos, and the radiologists report that indicates I have the same two spots with about a 30% occlusion (not enough to even bother to have treated) that I had 10 years previously when I had an actual cathertization and angiogram due to chest pains (turned out to be GIRD).

Honestly, you can find out exactly the state of your heart and coronary arteries with just a doctors prescription and a 10 minute session in an MRI machine. If they find occlusions find a cardiologist and be proactive. If they don't then don't worry about heart disease regardless of what the useless "risk factors" tell you. Of course you could still drop dead of a stroke, and the good news if you show all clear is your next highest chance of mortality is cancer, so yippee :)
11 weeks ago
11 weeks ago Link To Comment
Won't the Obamacare standard annual freebie exam cover an echo or stress echo, I haven't checked yet. My cheapjack Blue Shield policy does. And if your plan doesn't, you can negotiate a price and pay for it yourself, y'know.

But the newer science is pointing at inflammation markers (!) as more likely to be accurate, CRP and stuff.
12 weeks ago
12 weeks ago Link To Comment
I have heard about, but it has been a while. I had to look up the acronym, which can be tedious if an acronym stand for several dozen things.

CRP C-reactive protein

https://en.wikipedia.org/wiki/C-reactive_protein
11 weeks ago
11 weeks ago Link To Comment
I'm reading a lot of articles along these lines -- that we're treating a lot of markers that don't appear to be causes of disease after all.
This seems to be especially true of heart disease. Almost everything we've been told about lifestyle contributors to heart disease risk has been rendered doubtful by later rounds of study. Obesity, lipid levels, diet -- all have weaker associations than we've been told and efforts to manipulate them seem to have no effect.
Age and heredity seem to be the only predictors with much reliability and we can't do anything about them. And they aren't that strong; my parents lived to 71 and 79 and never had coronary vessel symptoms. Dad died of an infection in a heart valve but that's very different.
12 weeks ago
12 weeks ago Link To Comment
It reminds me of a tongue in cheek article about the great health experienced by sky divers. The conclusion was that everyone should take up sky diving in order to be healthy.
12 weeks ago
12 weeks ago Link To Comment
Interesting results and solid science, thanks.

The difference between evidence and causation is always slippery, the good thing about evidence is that you can see it and evaluate it while causation may be out of sight - until better science reveals it as new evidence. The good thing about causation is that it point to real reasons, although even a perfect causal model may have a dozen interacting factors that are very hard to manage.
12 weeks ago
12 weeks ago Link To Comment
"The difference between evidence and causation is always slippery"

Yes, and rarely understood and practiced by most in the so-called scientific community, of which medical practitioners increasingly seem to be a fringe element.

The amount of rank speculation and supposition that is passed off as settled science is staggering.


12 weeks ago
12 weeks ago Link To Comment
Took a Design of Experiments class. Professor was telling us of all the educated engineers who build their models of of systems with multiple factors and they investigate one factor at a time and hold all other variables constant.

It is extremely wasteful of money and because interactions is not considered at the end of it all there will be much gnashing of teeth.
11 weeks ago
11 weeks ago Link To Comment
That's only the first step, but it must be done before doing the interactions.
11 weeks ago
11 weeks ago Link To Comment
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