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ABC cholesterol controversy: a sceptic’s guide

Nov 06, 2013
There is reason to question the over-prescribing of statins for high cholesterol, argues Justin Coleman..

There is reason to question the over-prescribing of statins for high cholesterol, argues Justin Coleman..

On the past two Thursdays, the ABC’s Catalyst program set off a chain reaction of protest from sections of the medical community, aghast that the non-medical media would question the accepted wisdom that dietary saturated fats kill people and statins – medication to lower cholesterol – save lives.

Professor Emily Banks, chair of the Advisory Committee on the Safety of Medicines, warned the ABC to pull the second program. Yet the show went on: as befits a catalyst, it remained unaffected by the reaction it had produced.

Australian Medical Association president Dr Steve Hambleton claimed the programs “gave extraordinary weight to an opinion that is a minority view,” while his predecessor Professor Kerryn Phelps put her weight behind the minority view, tweeting “Time for Australian therapeutic guidelines on cholesterol and statins to be revisited.”

Plenty of fat spitting from the frying pan in all directions – so what is a non-expert to make of it?

As a GP who has no intention of ever doing a PhD on sub-types of fat (for fear of brain supersaturation), in these situations I whip out my most discriminating organ: my sceptic’s eye.

The result? Surprisingly, the two Catalyst programs scored almost polar opposites on the sceptometer.

The first program starts with a fellow called Dr Jonny Bowden saying:

I think it’s a huge misconception that saturated fat and cholesterol are the demons in the diet, and it is 100% wrong.

At the phrase “100%”, my sceptometer already gives a twitch. Just who is this confident expert?

A quick search reveals that Jonny describes himself as the Rogue Nutritionist to promote his 14 diet books. His website contains 20 pages of online shopping for bottled pills for anti-aging, detox, liver clearing, immune support and brain power.

Next up, cardiologist Dr Stephen Sinatra: at least he should know a thing or two about cardiovascular risks. But it doesn’t bode well that the home page of his website serves as a shop front to sell his own personalised brand of vitamin pills. You can buy Dr Sinatra T-support or click through to “anti-aging bombshell” Longevity Plus, before spending $55 on an “energy booster to refuel your cellular engines”. Er, no thanks, my engines are fine.

The next expert is US diet-book author and infomercial developer Dr Michael Eades. His website suggests that your weight loss solution is Metabosol™ Ultimate Success Pack, full of Diet Aid natural ingredients. And he’ll sell it to you for just US$209.95. Have these guys never heard of broccoli?

During Catalyst, Dr Eades questions the motives of the multibillion dollar food industry fuelling our phobia of fat in the diet. “That’s not science. That’s marketing,” he explains. At last: a statement where I can unreservedly accept that he would be an expert.

Honestly, even at this early point, I give up. The sceptometer has blown a fuse.

The quality of the messengers has me doubting their counterintuitive message. For now, I’ll stick with the 2012 Cochrane Review that suggested a modest (14%) reduction in heart attacks when participants tried to lower their saturated fat intake, although no conclusion could be drawn on overall risk of death. Certainly no reason to change mainstream dietary advice.

With a heavy heart (probably the trans-fats) I awaited the second Catalyst on statins, but to my pleasant surprise, the first commentator is respected academic Professor Rita Redberg, who prefers editing JAMA Internal Medicine to selling vitamin cure-alls. I have long been a fan of her Less is More series, which applies the blowtorch of best-available evidence to common medical interventions which our profession probably over-uses.

It’s hard to quibble with anything in her opening gambit:

The marketing concentrates on the fact that you can lower your cholesterol as if that was the end in itself, which it is not. Cholesterol’s just a lab number. Who cares about lowering cholesterol unless it actually translates into a benefit to patients?

The crucial question, then, comes down to mortality data in randomised control trials (RCTs). As end points go, death is easily measured, and all my patients consider it suitably clinically relevant.

Says Redberg:

One or two people in a hundred will benefit from taking a statin. What people don’t understand is that means the other 98 will get no benefit at all. It’s not going to reduce their chance of dying.

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Despite the shocked reaction to the Catalyst episodes, the science behind the claim that we overprescribe statins — the world’s most profitable drug class ever — has been steadily building for years.

This may be a revelation for the general public. And for doctors who rely on pharmaceutical reps for a substantial portion of their medical education. However, we learnt this back in 2010 from a meta-analysis of 11 RCTs looking at the ability of medications to reduce the risk of death in people who were at high risk of heart attack (but who had no history of heart attacks).

Its conclusion was fairly unambiguous: it did not find evidence that cholesterol-lowering drugs reduced the risk of death in people at high risk of heart attack.

Is this enough to show statins simply “don’t work”? No. But it is more than enough to make one suspect we may have overstepped the mark with many of the 40 million people currently prescribed statins.

And the mark — the cut-off point recommended by expert panels — keeps shifting lower, encouraging more treatment. Catalyst pointed out that eight out of nine of the 2004 US guideline panel members had a direct conflict of interest after declaring financial ties to the companies that manufactured statins.

This “guideline” conflict is, if anything, worsening. According to a September 2013 BMJ report:

… widespread financial conflicts of interest among the authors and sponsors of clinical practice guidelines have turned many guidelines into marketing tools of industry. Financial conflicts are pervasive, under-reported, influential in marketing, and uncurbed over time.

Because of their popularity and the sheer enormity of the profits involved, statins provide one of the most concerning examples of this type of market engineering.

This second Catalyst episode goes on to mention publication bias, pharmaceutical sponsorship potentiating biased reporting of outcomes, withheld trial data (see the AllTrials campaign) and the distasteful phenomenon of Key Opinion Leaders. These are specialist doctors identified and sponsored by the pharmaceutical industry to educate other doctors about diseases for which there is a branded treatment.

So was Catalyst wrong to air a program which, as National Heart Foundation CEO Dr Lyn Roberts pointed out, might encourage some people to stop taking their statins without consulting their GP?

No; the more likely effect is that people will start raising the issue with their GP, which is a good thing.

Although I can understand the NHF’s concern after suffering through the snake-oil salesmen in the first program, I think the second chapter effectively introduced an important debate — and certainly everybody is now talking about it.

So in the end, I’m glad I sat down for the sequel, despite my overheated sceptometer warning against it.

I did have to watch the dial anxiously when Jonny the Rogue Nutritionist returned to plug his Coenzyme-Q10 pills. But then, I’d also watch the dial if I ever attended a GP educational session and discovered that the specialist talking was a Key Opinion Leader and his topic was statins.

Justin Coleman is Senior Lecturer in the School of Medicine at Griffith University.

This article was first published at The Conversation.

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