ARE STATINS A PUBLIC HEALTH HAZARD?

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Mar 31, 2012, 12:02:27 AM3/31/12

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ARE STATINS A PUBLIC HEALTH HAZARD?

By Dwight Lundell MD (In his 25 years as cardiac surgeon Dr. Lundell did over 5,000 cardiac coronary by-pass procedures before becoming disenchanted with cholesterol causality and our 30 billion dollar statin industry. He is free now to speak his mind.)

The recent addition of warnings to the statin labels by the FDA has stirred a debate about the risks of statins and the possible benefits of statin therapy. Eric Topol, a former statin proponent has had the courage to examine the new data and has made the calculation that with 20 million people taking statins and one in 200 having the onset of new diabetes statins causes 100,000 new cases of diabetes.

100,000 new cases of diabetes is certainly a public health hazard.

Dr. Topol states,”We’re overdosing on cholesterol-lowering statins, and the consequence could be a sharp increase in the incidence of Type 2 diabetes.”

Asked why he changed his mind he says:

“Statins have been available since the 1980s but their risk of inducing diabetes did not surface for nearly 20 years. When all the data available from multiple studies was pooled in 2010 for more than 91,000 patients randomly assigned to be treated with a statin or a sugar pill (placebo), the risk of developing diabetes with any statin was one in every 255 patients treated. But this figure is misleading since it includes weaker statins like Pravachol and Mevacor — which were introduced earlier and do not carry any clear-cut risk. It is only with the more potent statins — Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) — particularly at higher doses, that the risk of diabetes shows up. The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes.

The statin defenders came out with guns blazing!

Cedars-Sinai cardiologist Sanjay Kaul argued that, “The overall benefits of statins trump these safety concerns.” Steven Nissen of the Cleveland Clinic argued, “The diabetes is a very small uptick in blood sugar that makes a few more people cross the threshold we call diabetes. The reductions in morbidity and mortality are the same in those who get diabetes as those who don’t. It’s very difficult to say it should change our assessment of risk and benefit.”

Dr. Kaul stated:

“I think while Topol’s estimate for statin-induced diabetes might not be off target, he fails to consider the treatment benefit in these patients. For example, it is reassuring to note that within JUPITER, 80% of all incident diabetes occurred among those who had elevated fasting glucose (>100 mg/dL) at study entry, a subgroup that also experienced a statistically significant 34% reduction in the trial’s primary endpoint of heart attack and stroke. So the patients who develop diabetes (1 in 200) are more likely to have elevated fasting blood sugar at baseline, and these patients are also likely to benefit from statins (2 in 100). It is hard to conceive how genomics can differentiate the two.”

Dr. Topol responds:

“Dr. Kaul’s comments are off-target! Using the 34% reduction of events as justification is frankly deceptive, since it amounts to 2 per 100 patients and indeed I duly noted this treatment benefit in my NYT op-ed. The diabetes risk does not just show up in JUPITER, it is consistent in every trial of high potency statins. Beyond that, in the randomized trials of intensive vs. moderate statin dosing the induction of diabetes was even more than 1 in 100 patients. In fact it was 1 in 50 in the TNT trial of high dose Lipitor! Here we are talking about an excess compared with a statin control group, which is all the more worrisome. I presented the most conservative numbers possible, rounding the statin-induced diabetes to 1 in 200.”

Not a good thing for the public health and certainly not good for the individual affected with a new serious chronic illness, counters Dwight Lundell, author of this article. If there were a major suppression of heart attacks or strokes or deaths, that might be justified. But in patients who have never had heart disease and are taking statins to lower their risk (so-called primary prevention), the reduction of heart attacks and other major events is only 2 per 100. And we don’t know who the 2 per 100 patients are who benefit or the one per 200 who will get diabetes! Moreover, the margin of benefit to risk is quite narrow.

To me the whole thing is silly, with no benefit for the majority of patients taking statins, and no real evidence that lowering cholesterol lowers the risk of heart attack. To recommend stains is just wrong and ignorant.

No one has offered a plausible explanation as to why statins might cause diabetes; therefore the whole debate is off target.

Could it be that the recommended high carb diet which is part of the official religion of current cardiology is the cause of the diabetes and the statins have nothing to do with it?

I must remind these folks that correlation is not causation, so please try to be a little less histrionic and a little more scientific.

Diabetes is a disease of carbohydrate intolerance and yet we recommend a high carbohydrate diet both for heart disease and diabetes, all diabetics have heart disease. Will someone explain why this is a good idea?

So maybe it is the American College of Cardiology that is the public health hazard.

Dwight Lundell, MD
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Duane Graveline MD MPH
4414 Cormorant Lane
Merritt Island, FL, 32953
www.spacedoc.com

NOTE: Shared with permission from Dr Duane Graveline
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