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Sunday, April 29, 2012

Why Asians Should Ignore the Cholesterol Sham, and Why Healthy People Should Not Take Statins- Colpo

Why Asians Should Ignore the Cholesterol Sham, and Why Healthy People Should Not Take Statins

  Saturday, April 28th, 2012

Folks, before I get rolling, I would just like to dedicate this first instalment of many more cholesterol updates to come to my good buddies Pee Pee and Don Matesz and all those other dopey buggers who make a pastime of accusing me of being a cherry-picker. Today, I’m going to share with you studies you’ve probably never heard of, because they just happen to flatly contradict the mainstream assertion that low cholesterol is healthy and hence are quietly shoved aside by purveyors of this belief due to their embarrassing nature. As we know, one of the favourite strategies humans have for dealing with evidence that contradicts their cherished dogmas is to simply ignore it.

In the twisted worldview of Don, Pee Pee and their ilk, by presenting the studies that you likely never would have heard of due to their embarrassing nature, it is people like me – not them – that are cherry-picking.

Yeah, no worries.

Come and Get ‘Em!
Folks, who wants some cherries? I’ve got a basket full here, and you’re all welcome to grab a handful. They might not be highly-hyped, front page, AHA- or Big Pharma-press-release cherries, but they are definitely sweet, tasty, and certified peer-reviewed delicacies. Enjoy!

Low Cholesterol is Accompanied by Increased Mortality from Stroke, Heart Disease, and Cancer: The Jichi Study
The Asians we are told, are shining examples of the cholesterol theory. They eat a low-fat diet, which gives them wonderfully low cholesterol levels, which in turn not only protects them from heart disease but endows them with the longest average life expectancy on Earth.
Sounds great, doesn’t it?

Too bad it’s complete nonsense.

Being the cherry-picker I am, I discussed the evidence, so often ignored by others, in The Great Cholesterol Con that low cholesterol is strongly associated with increased mortality in Japan.
Yeah, shame on me for pointing out to our Japanese brethren that this whole cholesterol-lowering thing is just another overhyped Western wank, one with the potential to harm instead of hurt their health.

Funnily enough, I don’t feel any shame at all. Au contraire, I believe reporting the facts is a noble thing to do, even if it upsets every last dogmatic sod who can’t get his head around the fact he has fallen hook, line and sinker for a load of unscientific rot.

Which is why, dear readers, I bring you the results from The Jichi Medical School Cohort Study, which involved 12,334 healthy Japanese adults aged 40 to 69 years who underwent a mass screening examination (1992-2005), including total cholesterol measurement. Information regarding cause of death was obtained from death certificates, and the average follow-up period was 11.9 years. In total, 635 men and 423 women died during the study period.

The subjects were divided into 4 groups according to total cholesterol level (<4.14mmol/L; 4.14mmol/L to <5.17 mmol/L; 5.17 mmol/L to <6.20 mmol/L, and; >6.21 mmol/L).
Before I report the results, it should be pointed out that the lowest quartile of cholesterol (<4.14mmol/L) , in both male and female participants, was marked by a higher number of current cigarette smokers.

So did multivariate analyses, which many misguided Western researchers seem to think grants epidemiology the same accuracy as RCT data, and which in this instance included adjustment for smoking, age, systolic blood pressure, HDL, drinking, and body mass index confirm the wonderful life-saving benefits of having low cholesterol?

Nope.

The safest cholesterol range in the study was 4.14–6.20 mmol/L in men, and 4.14mmol/L – >6.21 mmol/L in women. As the researchers stated:

“We noted a clear relationship between low cholesterol and increased mortality. Okamura et al reported that occult liver diseases are associated with mortality; however, in the present study, the relationship between low cholesterol and increased mortality was unchanged in analyses that excluded deaths due to liver disease. Our results suggest that hemorrhagic stroke and heart failure excluding myocardial infarction,contribute to the relationship between low cholesterol and high mortality.”

You can check out the full text of the study here:

Nago N, et al. Low Cholesterol is Associated With Mortality From Stroke, Heart Disease, and Cancer: The Jichi Medical School Cohort Study. Journal of Epidemiology, 2011; 21 (1): 67-74.
Yeah, I know, shame on me for allowing you to view the paper yourself…I need to do what folks like Don and Pee Pee do and make sweeping claims and libelous accusations, then refuse to back them up with even a single paper!

Must be the cherry-picker in me…

Low Cholesterol is Associated with Increased Mortality from CVD in Korean adults.
Maybe the Koreans can save the cholesterol cartel’s Asian thesis, no?
No.

A total of 12,740 Korean adults aged 40 to 69 who underwent a mass screening examination were followed up from 1993 to 2008. Groups with the lowest cholesterol (< 160 mg/dL) as well as the highest (>= 240 mg/dL) were associated with higher CVD mortality in analysis adjusting for age, sex, smoking and drinking status, body mass index, level of blood pressure, triglyceride and HDL.

The researchers noted:

“Based on the results of this study, caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk in Korean adults.”

Aw c’mon guys, the nice folks from Big Pharma won’t like that, will they? Don’t you know that the Asian market, especially China, represents a huge and largely untapped reservoir of profit, but by showing the kind of independent and critical thinking sadly lacking in most of your Western colleagues you’re ruining the party?

Tsk tsk.

Again, dear readers, if you’d like to read the paper yourself, feel free to do so here:

Bae JM, et al. Low cholesterol is associated with mortality from cardiovascular diseases: a dynamic cohort study in Korean adults. J Korean Med Sci. 2012 Jan; 27 (1): 58-63.

Statins are Largely a Waste of Time
As for statins, they’re not just a wank for Asians, they’re a load of cobblers for Westerners too.
The Journal of the American Medical Association recently published a “for” and “against” installment posing the following hypothetical question:

“Should a 55-year-old man who is otherwise well, with systolic blood pressure of 110 mm Hg, total cholesterol of 250 mg/dL, and no family history of premature CHD be treated with a statin?”

To answer this question, JAMA enlisted Blaha, Nasir and Blumenthal from The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease for the “yes” case, and Redberg and Katz from the Division of Cardiology, Department of Medicine, University of California, San Francisco (Dr Redberg) and Department of Health Services, County of Los Angeles (Dr Katz) for the “no” case (Drs Redberg and Katz are also Editor and Deputy Editor, respectively, over at the Archives of Internal Medicine).

To support their “yes” case, the Hopkins crew begin by citing a bunch of cholesterol guidelines that were formulated by panel members sponsored by manufacturers of statins. Yep, I’m sure we can rely on those for accurate, unbiased guidance when tooling around with someone’s health!

They then cite the WOSCOPS and AFCAPS/TexCAPS trials and report the former lowered heart attack and CHD mortality by 31%, while the latter reduced heart attacks by 40%.
Um, fellas … isn’t there something you’re forgetting to tell us about those studies?

Like the fact that the 27% reduction in CHD mortality in AFCAPS/TexCAPS did not reach statistical significance? And that there was no reduction whatsoever in overall mortality?

And the fact that the 27% reduction in CHD mortality in WOSCOPS also did not reach statistical significance?

Instead of reporting these facts about actual death rates, the researchers only reported (read: cherry-picked) outcomes that managed to reach statistical significance and ignored those that didn’t.
Recommending a toxic drug to healthy individuals free of CHD using such dubious interpretation of these largely unsuccessful studies is, to my way of thinking, BoLLOCKS.

The Hopkins team then trot out the absolute farce that was JUPITER, this time including a total mortality reduction of 20% reported in that trial. For me to outline all the discrepancies in this trial – that was conveniently cut short as the mortality trajectories of the treatment and control groups began to menacingly converge – would be a whole other article. Luckily, someone else has already saved me the time and posted a pearler of a critique right here:

http://junkfoodscience.blogspot.com.au/2008/11/when-news-sounds-too-good-statins-new.html

After reading that, I’m sure most everyone apart from Pee Pee, Matesz and the JUPITER researchers themselves will agree that citing JUPITER in support of anything other than the all-too-frequent shadiness of Big Pharma-sponsored research is POPPYCoCK and HogWASH.

The Hopkins team then go onto cite some more theoretical figures, then argue that statins are safe, claiming only 5% of patients experience muscle pains.

Incorrect. The reality is that such complaints are dramatically underreported, thanks to doctors’ refusal to believe the ‘wonder drug’ statin they prescribed could ever do anything negative to their patient. And in those who do acknowledge the cause of the muscle pain, filing an official complaint is a time-consuming affair for which they receive no compensation and may even be subject to interrogation about the circumstances that led to the filing of the report.

But what happens when, instead of brushing people off and telling them their symptoms are just due to “getting old”, researchers carefully inspect patient data and make further enquiries? A study published in the October-November-December 2009 issue of Primary Care Cardiovascular Journal, indicates that statin-induced myopathy is far more common than previously claimed by drug companies and health officials. Researchers analyzed the patient records of one 8,000 patient practice and found only one recorded case of muscle symptoms in a patient taking statins. But after questioning 96 randomly selected statin-using patients from the practice, they identified 19 cases of potential muscle damage:

Sciberras D, et al. Is general practice the optimal setting for the recognition of statin-induced myotoxicity? Primary Care cardiovascular Journal, Oct-Nov-Dec, 2009; 2: 195-200.

As for the question of whether statins should be prescribed to women, Blaha et al cite a review by Kostis et al that claims statins also work in women – but ignore two other reviews that concluded statins do not:
  1. Walsh JM, Pignone M. Drug Treatment of Hyperlipidemia in Women. JAMA. 2004; 291 (18): 2243-2252.
  2. Petretta M, et al. Impact of gender in primary prevention of coronary heart disease with statin therapy: A meta-analysis. International Journal of Cardiology, 2010; 138 (1): 25-31.
So what do Redberg and Katz, who argue the “No” case, have to say in response to the selectively cited arguments of Blaha and co?

Instead of citing a small handful of incompletely reported trials, they report that:

“Data from a meta-analysis of 11 trials including 65 229 persons with 244 000 person years of follow-up in healthy but high-risk men and women showed no reduction in mortality associated with treatment with statins. A 2011 Cochrane review of treatment with statins among persons without documented coronary disease came to similar conclusions. The Cochrane review also observed that all but one of the clinical trials providing evidence on this issue were sponsored by the pharmaceutical industry. It is well established that industry-sponsored trials are more likely than non–industry-sponsored trials to report favorable results for drug treatment because of biased reporting, biased interpretation, or both of trial results.”

As for the commonly claimed low rate of side effects in statin users, they note:

“This underestimation of adverse events occurs because the trials excluded up to 30% of patients with many common comorbidities, such as those with a history of muscular pains, as well as renal or hepatic insufficiency. Many randomized trials also excluded patients who had adverse effects of treatment during an open label run-in period. For example, in the Treat to New Targets trial, after initial exclusions based on comorbidities, an additional 35% of eligible patients, or 16% of patients, were excluded during an 8-week, open-label, run-in phase because of adverse events, ischemic events, or participants’ lipid levels while taking the drug not meeting entry criteria. Additionally, the results of randomized trials of statin treatment likely underestimate common symptoms such as myalgia, fatigue, and other minor muscle complaints because these studies often only collect data on more quantifiable adverse effects such as rhabdomyolysis.

Numerous anecdotal reports as well as a small trial have suggested that statin therapy causes cognitive impairment, but this adverse outcome would not have been captured in randomized trials. The true extent of cognitive impairment associated with statins remains understudied. It is disappointing that more data are not available on important adverse events associated with statin treatment, despite millions of prescriptions and many years of use. This information could be easily collected in observational studies and from registries. One population-based cohort study in Great Britain of more than 2 million statin users found that statin use was associated with increased risks of moderate or serious liver dysfunction, acute renal failure, moderate or serious myopathy, and cataract. The risk of diabetes with statin use has been seen in randomized clinical trials such as JUPITER, which found a 3% risk of developing diabetes in the rosuvastatin group, significantly higher than in the placebo group. In observational data from the Women’s Health Initiative, there was an unadjusted 71% increased risk and 48% adjusted increased risk of diabetes in healthy women taking statins.”

Their conclusion?

“Based on all current evidence, a healthy man with elevated cholesterol will not live any longer if he takes statins. For every 100 patients with elevated cholesterol levels who take statins for 5 years, a myocardial infarction will be prevented in 1 or 2 patients. Preventing a heart attack is a meaningful outcome. However, by taking statins, 1 or more patients will develop diabetes and 20% or more will experience disabling symptoms, including muscle weakness, fatigue, and memory loss.”

Statins. They still suck.
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Read the complete article here.

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