Statins For Children- This Is Madness

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Obviously greed and self-vested interests at their worst...

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Misty L. Trepke

http://www..com

 

STATINS FOR CHILDREN – THIS IS MADNESS

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

December 3, 2003

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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