STATINS FOR CHILDREN – THIS IS MADNESS

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http://www.redflagsweekly.com/kendrick/2003_dec03.html

 

 

December 3, 2003

 

STATINS FOR CHILDREN – THIS IS MADNESS

 

By RFD Columnist Malcolm Kendrick MbChB, MRCGP

 

(email - malcolm )

 

When someone sent me a copy of an article in the Washington Post, stating that

more and more doctors now think that children as young as four should be put on

statins, my fingers started to itch.

 

Here’s the offending headline:

 

‘Despite Controversy, Pressure Grows to Treat High Cholesterol in Children

After Studies Link Elevated Levels to Adult Heart Disease.’

By Elizabeth Agnvall

Special to The Washington Post

Tuesday, December 2, 2003

 

The first thing that I have to point out here is that, in primary prevention

trials, statins have never been found to reduce the risk of death. I don’t care

if they have been found to reduce the rate of heart disease. Does it really

matter if someone is saved from dying of heart disease, only to die of something

else?

 

By primary prevention trials, I mean trials in people who, whilst they may have

risk factors for heart disease, have not been found to have any clinical signs,

or symptoms related to heart disease.

 

Secondary prevention trials are different. These are done on people who have

already suffered a heart attack, or have angina, or some other clinical

manifestation of CHD. And it is true that in ‘secondary prevention’ trials,

statins have been found to reduce the rate of dying of heart attacks, and also

to reduce overall death rates. By a small, but significant, amount.

 

However, that is not relevant to this discussion. Because, by definition, all

children are in the primary prevention category. And this means that there is

not one scrap of evidence to suggest that statins will do them any good. The

best you might manage is to shift their cause of death from heart disease to

something else – usually cancer – about sixty years in the future.

 

How do I know this? Because the clinical trials tell me so.

 

If we look at five major primary prevention trials: PROSPER, ALLHAT, WOSCOPS,

ASCOT and AFCAPS. (Don’t worry about the acronyms, they are not important, they

are just supposed to make the trials memorable). We can pull them apart to look

at the figures.

 

By the way, if you want to check my figures visit The Therapeutics Initiative at

The University of British Columbia http://www.ti.ubc.ca/ and look for

Therapeutics newsletter number 48. Or, get the data from the trials themselves.

 

These five trials had, between them, over forty thousand patients enrolled. Most

of them lasted at least five years, and they have all been endlessly quoted in

the medical literature. In short they are big, important and influential.

 

So, what was the overall mortality rate in those given statins versus the

‘control’ population?

 

Morality in those on statins was 6.6%

Mortality in the control population was 6.9%

 

And what was the percentage of serious adverse events (SAEs)? A serious adverse

event is something like developing cancer, or having a non-fatal MI, or a

non-fatal stroke. So, pretty damned serious.

 

In fact, only two of trials reported this, as the majority of statins trials

keep quiet about SAEs.

 

Serious adverse events in the control population was 43.9%

Serious adverse events in those on statins was 44.2%

 

I suppose you may be thinking, my goodness, there was a 0.3% reduction in

overall mortality. It may be small, but it’s still there. True. However,

although these five trials are usually presented as purely primary prevention

trials, they all included a secondary prevention population, 18% on average.

This more than accounts for any difference in overall mortality.

 

Even if it doesn’t. I must point out that the difference is not large enough to

discount the possibility that this was merely a chance finding. These figures do

not get anywhere near statistical significance - the holy grail of clinical

trials.

 

In addition to this, the 0.3% reduction, if it really exists, took five years to

appear. Which means that, even if you take the best case scenario possible, and

ignore the fact that any difference is most likely due to chance, you would have

to a take a statin for fifty years to reduce your risk of dying by 3%. At the

same time, of course, you would have a 3% greater risk of suffering a serious

adverse event, such as a stroke, or developing cancer.

 

Does this really represent powerful enough evidence to warrant starting a

four-year-old child on statins, and keeping them on for the rest of their life?

 

I don’t think so. Especially not in the case of this Washington Post reporter.

For, in her article, she was using the example of a four-year-old girl. And what

do the statin trials tell us about the benefits of statins in primary prevention

in girls, or women? According to The Therapeutics Initiative group:

 

‘There were 10,990 women in the primary prevention trials (28% of the total).

Only coronary events were reported for women, but when these were pooled they

were not reduced by statin therapy. Thus the coronary benefit in primary

prevention trials appears to be limited to men.’

 

 

What the statin trials tell us about women is that, in primary prevention,

statins can’t even manage to prevent heart disease, let alone anything else!

 

Has the world gone completely mad? Are we really suggesting that we should start

a healthy four-year-old girl on a medicine, and continue this medicine for the

rest of her life? Something that could turn her into one of the ‘worried well’,

and even if it doesn’t, will most likely cause side-effects.

 

Can we really be contemplating this, when all of the evidence that exists points

to the fact that STATINS WILL DO HER ABSOLUTELY NO GOOD AT ALL!

 

Apparently, we are. ‘Anyone for tea?’ Asked the Mad Hatter.

 

READ ALL OF DR. MALCOLM KENDRICK’S RFD COLUMNS

 

 

 

 

 

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