New post-statin drug doesn’t need proof it works

There has long been a surreal quality to cholesterol lowering drugs; prescriptions in the millions, earnings in the billions and yet a growing evidence that if you are taking them to prevent your first heart attack, unless you are one of the lucky ones – one in 1/300, 1/500, 1/700; the figures vary – they won’t benefit you at all.

So making a rational decision about whether to take them or not is tricky – either your nice GP wasn’t up to speed with the research or maverick doctors like Dr Malcolm Kendrick and Dr John Briffa had missed something vital – even though no one had been able to point out what it was.

But now the statin saga has taken a positively Alice in Wonderland twist which Dr Kendrick traces in his latest post on HealthInsightUK.org – the forum that is looking for sane solutions. Essentially what has happened is this. As Dr Kendrick described last week – Beware new Cholesterol drug coming  – a new and more powerful cholesterol lowing drug is in the pipeline that will be able to drive cholesterol right down in combination with a statin – it may well damage the liver though.

However hot on the heels of Dr Kendrick’s post, new guidelines were issues by the two of the big American heart charities saying that clinicians shouldn’t try to drive cholesterol right down below 2.5 mmol/L because, and I quote:  “there is simply no evidence from randomized, controlled clinical trials to support treatment to a specific target.”

Amazing, after a decade of pushing everyone to up their statin dose so as to get cholesterol as low as possible suddenly there’s just  the bland statement: actually there is no evidence at all for the advice. And not one U-turn but two ; Er statins don’t work by lowering cholesterol but because they reduce inflammation.

New drugs should show they cut risk

I know , for the true statin believer this volte-farce (sic) must come as a shock, although it is what Drs Kendrick and Briffa and others have been saying for years. Instead, say the new guidelines, clinicians should use the drugs to “treat risk” which means that you have to be able to show that the drugs are actually having a clinical benefit. Leaving aside the difficulty of doing that for what’s knows as “primary prevention” – when you haven’t had an attack – the big implication is that any new cholesterol drugs should be able to show that people actually live longer as a result of taking them.

Following publication of the new guidelines there was was a brief period of intense and worried speculation – did this mean that the new post statin drug was going to have to show not just that it lowered cholesterol – no longer the important thing – but that it actually made a difference to outcome? That could take years and it might not actually be possible.

But then the FDA, the American drug watchdog charged with protecting consumers, came to the rescue of a drug predicted to earn billions. It ruled that to get a license the new drug didn’t have to show it actually helped people live longer, only that it brought cholesterol right down, despite the new guidelines. The inescapable conclusion is that  a major plank of the medical campaign to cut the risk of heart disease is being designed in Wonderland.

And if you doubt it and say loyally that we know that lowering cholesterol cuts heart disease, consider the case of the cholesterol lowering drug Ezetimibe – written about here – that very effectively lowers cholesterol, has been available on the NHS for about a decade now, costs the NHS 70 million a year but has never been shown, not for lack of trying, to cut anyone’s chance of a heart attack.

Why has the sunshine drug been left in the shade?

And there is another new post on HeathInsightUK that raises a quite different set of worrying questions. It is about the quality of the evidence being used by the NHS to make decisions about who should be getting a supplement of Vitamin D and how much.

You may sometimes have wondered why it is that, despite growing evidence that having healthy levels of vitamin D is linked with a range of health benefits, it isn’t anywhere on the medical prevention radar? After all, if the NHS is happy to spend hundreds of millions on a drug that has never been shown to reduce the risk of a heart attack – and has no other benefit – why is it not possible to take a more proactive approach to vitamin D?

But now thanks to an investigation by Rufus Greenbaum, published today on HealthInsightUK.org. we now have a much clearer idea about why the official response has been so laggardly. The simple and appalling answer is that the government committee set up to advise on supplements and diet is just not up to speed on the new vitamin D data. It appears to know little about the new data and to be still stuck in a 50-year-old view of vitamin D as good for preventing kids developing the bone disease rickets and not much else.

Evidence based medicine doesn’t just mean establishing that one profitable treatment  does work; it also means not ignoring evidence something less commercial could be just as effective.