Skepticism about science and medicine

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Posts Tagged ‘Lipitor’

STATINS are VERY BAD for you, especially FOR YOUR MUSCLES

Posted by Henry Bauer on 2013/03/29

There is no convincing evidence that what is currently regarded as “high cholesterol” is harmful; rather, cholesterol is actually good for you  at levels (200-260) that current practices seek to lower.

Lip service is paid by official agencies and by drug advertisements to using diet and exercise as the first way to lower cholesterol. In practice, innumerable people are taking statins to that end.
That end can be quite literal, because statins can kill you. Bayer’s statin, Baycol, did kill at least 800 people before it was very belatedly withdrawn from the market:
“Bayer had their statin (cerivastatin, Baycol) approved in June 1997. Within 4 months, Bayer knew that it could cause rhabdomyolysis — muscle wasting and death. But this risk was not noted in the drug’s package insert for another year-and-a-half, and the drug was withdrawn only in August 2001 . . . after some hundreds of acknowledged deaths” and perhaps 100,000 or even more actual deaths.

All statins do much the same sort of thing. Drugs are called statins because they do that sort of thing. All statins have the same type of “side” effects, albeit not to the same degree; and of course dosage also matters.
I am perpetually astonished that anyone would take these drugs after learning about their “side” effects. For instance, one of the daddies of them all, Lipitor, “can cause serious side effects. These side effects have happened only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or LIPITOR is stopped [emphases added]”.

Note how this official Lipitor website tries to downplay the risks while guarding against law suits by revealing the essential facts. The admission that the side effects can be serious — “fatal” would however be more accurate — is followed by something like a lie about numbers of people affected, and the doubtfully true insinuation that the side effects can be reversed, and the nice-sounding but meaningless and misleading notion that one’s doctor can “monitor” for them.

The term “side” effect is in itself altogether misleading. Chemicals do what they do irrespective of what we might want them to do or not to do. “Side” effects are just as real as the desired effect. Drugs are supposed to be approved only if they are safe as well as effective, in other words that the “side” effects are not dangerous enough as to outweigh their possible benefits. Lowering cholesterol has not been shown to be of benefit. Therefore any undesirable “side” effects are too many and too much.

But let’s continue with Lipitor’s listing of its “side” effects.
“These serious side effects include:
Muscle problems. . . . weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a rare muscle problem [emphasis added]”.
Yet “In clinical studies, patients reported the following common side effects . . . . Muscle and joint pain” [emphasis added] and right at the very bottom of the page, “Common side effects are diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests” [emphases added].
In other words, Lipitor doing unpleasant things to muscles is anything but rare.

The CYA* rationale for the manner in which the manufacturer describes Lipitor’s “side” effects is illustrated also by
Call your doctor right away if:
You have muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual”.
How on earth is one to judge whether there’s no good reason? How many of us would not feel embarrassed to “ask our doctor” because we feel weaker and more tired than we might like? With a fever, of course one expects to feel weak and tired. And what does “right away” even mean in this context? Do you feel weaker or more tired “than usual” all of a sudden?
Anyway, it’s one thing to call our doctor “right away”, but getting through is a different matter. The clinic where my (excellent, cautious, exceptionally reasonable and forthcoming) doctor works has one of those robotic phone-answering systems whose first words are, “If this is an emergency, call the hospital”.

Muscle problems are not “side” effects of statins, they are direct effects of statins.
When official statements describe statins as well tolerated, what they mean is that the typical weakness induced by statins can be lived with by many people for varying lengths of time.
But since “high” or “bad” cholesterol is not harmful, why deliberately induce any muscle pain or weakness at all?

The claimed benefits from using statins and lowering cholesterol are based on clinical trials paid for by the manufacturers of statins. Those clinical trials are not be trusted, for a large number of reasons, including that they need be no longer than 6 months and that only two successful trials need be submitted to the Food and Drug Administration — no matter how many unsuccessful trials there had also been!
A comprehensive critique explaining why not to rely on clinical trials in general has been given by Ben Goldacre (MD and Guardian columnist) in Bad Pharma.  Perhaps the most direct proof that these trials are typically biased is that almost every trial concludes that the drug made by the particular sponsor of the trial is not only safe and effective but also better than its competitors. It’s rather like that fictional place (Lake Wobegon) where all the children are above average: All prescription drugs are superior to all the others, if you were to believe the clinical trials.

Even then, those typically biased clinical trials have not shown appreciable benefit for statins. A review of data on 5 common statins showed that they produced an average reduction of mortality risk of only 0.27% per year (Joel Kaufmann, Malignant Medical Myths, pp. 88-90). The risk of non-fatal heart attacks was reduced by only 0.037%, whereas Bufferin reduced that risk by 0.11%, three times better (Kaufmann p. 93).
Those numbers are reductions in absolute risk of all-cause mortality, which is the most meaningful for human patients. It’s not much good to reduce one’s risk of heart disease by, say 50%, if the drug we take increases our risk of death by an equivalent amount; death would come just as soon without treatment, just more expensively. But drug companies invariably report reductions in relative risk, not absolute risk. So trials with pravastatin claim a risk reduction of 22% (relative, compared to controls) when the absolute reduction is only 0.2 – 0.5% (Kaufmann, p. 89).
The very small risk reduction by statins is nowadays ascribed by many researchers to an anti-inflammatory action rather than lowering of cholesterol; but anti-inflammatory action weaker than that of Bufferin, which is cheaper and much safer.

A very general axiom nowadays should be: If you really need to take a drug, take the one that has been on the market for the longest time and has been used by the largest number of people. The newer a drug is, the more likely that it will be withdrawn soon after having been first approved (Dogmatism  in Science and Medicine, Table 5, p. 240 and associated text).

Not only have trials shown that statins are of negligible benefit, the risk of damaging “side” effects is greater at higher doses, another illustration that the “side” effects are just as direct and immediate as the desired effect. Less obviously, “side” effects are also greater when certain other drugs are being taken at the same time; a significant factor since so many people are taking so many prescription and other drugs.

This blog is already long enough. A later posting will explain why the “side” effects invariably accompany the cholesterol-lowering, and how the drug companies have deliberately avoided telling statin users of things to do to lessen the impact of the common “side” effects.


*   CYA = Avoid being sued, also known as “cover your arse”

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