Tag Archives: British Medical Journal

So much for scientific debate

I thank Ted Hutchinson for pointing me at this article in the Irish Independent. It appeared on the 5th of October, and I reprint it in full, here.

A LEADING vascular surgeon, whose research review concluded cholesterol-lowering medicines may do more harm than good for many otherwise healthy people, has been gagged by the Health Service Executive.

Sherif Sultan, a senior medic at University College Hospital, Galway, reviewed a range of studies of statins and found a lack of evidence to show they should be given as a means of prevention to healthy people with high cholesterol but no heart disease.

Mr Sultan and his surgeon colleague Niamh Hynes said lifestyle changes to reduce cholesterol were better because this allowed people to avoid the risk of statins’ side effects.

However, in a statement last night, Dr Pat Nash, a cardiologist and the group clinical director in University College Hospital said the recently published views of his colleagues were “not representative” of those in Galway or neighbouring hospitals.

“As group clinical director of the West/North West Hospitals Group, and a working cardiologist, I wish to reassure patients that statins are safe,” said Dr Nash.

“These are very important, well-validated drugs for the treatment of elevated cholesterol. We have extensive evidence to show their benefit and to show that they improve outcomes for patients with heart disease and stroke and that they have a role in preventing heart disease and stroke.

“As always, if patients have any concerns, they should not discontinue their medication without discussing with their GP or consultant.”

Asked to comment, Mr Sultan said: “I have received an official warning from the HSE and have been instructed not to liaise directly with the press in my capacity as a HSE consultant.” However, he said he could continue to comment as a consultant vascular surgeon at the Galway Clinic, where he has a private practice.

The HSE declined to comment on the reasons for ordering Mr Sultan not to speak as a public consultant. He said he stood by his analysis of the role of statins in otherwise healthy patients with high cholesterol. He pointed to another recently published review on exercise versus drug therapy in the management of pre-diabetes and cardiovascular disease.

“That ‘British Medical Journal’ analysis showed the superiority of exercise over drug therapy extends even to secondary prevention (where patients have developed disease)1.

This story has been rumbling on for a while. A report on the research paper can be found in the Irish Medical Times from a couple of weeks before.

The under-reporting of findings on major adverse effects of statin therapy and the way in which they had been withheld from the public, and even concealed, is a scientific farce, claims new Irish research.

Mr Sherif Sultan, Consultant Vascular and Endovascular Surgeon, and Niamh Hynes, Clinical Lecturer In Vascular and Endovascular Surgery, claimed their study, just published in the Journal of Endocrine and Metabolic Diseases (2013, 3, 179-185) highlights the major side-effects and dangers of statins.

They said there is a categorical lack of clinical evidence to support the use of statin therapy in primary prevention. They are both based in the Western Vascular Institute at University College Hospital Galway and the Galway Clinic. “Odds are greater than 100-to-1 that if you’re taking a statin, you don’t really need it2..

I was sent the original paper by Sherif Sultan a couple of months ago, and it is very scathing about statins….. very scathing indeed. It even suggests, perish the very thought, that pharmaceutical companies may have been trying to present statins in the best light possible. I find such a suggestion almost impossible to believe. Knowing how completely ethical these companies are.

Anyway, I suppose the key phrase in all of this sorry episode is the following:

The HSE declined to comment on the reasons for ordering Mr Sultan not to speak as a public consultant.”

If the Health Service Executive were to comment, what could they say to justify their actions?

The hell with scientific debate. He should just damned will shut up and say what we want him to say?”

“How dare anyone criticise the sainted statins which work in mysterious ways their wonders to perform.”

We expect utter loyalty from those who work in the glorious Irish Health Service. Those who do not support us can expect serious sanctions……”

On balance, declining to comment is probably the best policy for the HSE. Because if you start trying to justify why you are gagging a researcher for trying to tell the truth then, well, you will end up having to justify state censorship of scientific debate. Which never looks that good on the printed page, I find.

I feel I should sign off this blog with a quote from George Orwell, taken from 1984. “Being in a minority, even in a minority of one, did not make you mad. There was truth and there was untruth, and if you clung to the truth even against the whole world, you were not mad.”

1: http://www.independent.ie/irish-news/hse-gags-surgeon-after-cholesterol-drug-claims-29636095.html

2: http://www.imt.ie/news/latest-news/2013/09/study-claims-to-highlight-the-ugly-side-of-statins.html

How Risky Is A Risk?

 

[I was contemplating risk the other day, when someone forwarded me an article I wrote a couple of years ago on risk. I think it is still highly relevant to what is happening today with the mangling of medical statistics]

I have only just recovered from the idea that everyone in the whole world over the age of fifty-five should spend the rest of their lives on six different medications, all stuck together in one great big pill. The following was headline from a study in the BMJ.

‘Polypill—A Statin plus 3 Blood Pressure Drugs plus Folic Acid plus Aspirin. Authors claim Polypill would reduce risk of dying from coronary heart disease by 80%. The authors of the polypill article in the BMJ made the claim that taking their polypill would reduce the risk of dying of coronary heart disease (CHD) by 80%.’

You may have seen the non-story about the, yet to be marketed polypill, peddled in the British Medical Journal (BMJ). I was stimulated to look again at the concept of risk.

Whether or not you believe their figures—and I don’t—I sense that this figure of 80% would be taken by most people to mean that eighty out of one hundred people would be saved from death if they took this magic tablet. But this figure, if true, could only possibly be a relative risk reduction. And a relative risk reduction means almost nothing, by itself.

However, because everyone’s eyes glaze over whenever you start talking about statistics, most researchers manage to get away with using relative risk reduction figures when, in reality, they should be shot for doing so. Now, here’s a challenge. The challenge to make a short article about statistics interesting. Okay, that’s not possible. But maybe a little bit interesting?

You must know the time period, and the absolute risk, for the relative risk to have any meaning

When you talk about a risk, you need to know the absolute risk of a thing happening. For example, the risk of getting struck by lightning. I don’t actually know what this risk is, but I would imagine it is about one in five million. But again, that figure means little unless you put a time scale on it. Is this a one in five million risk over a hundred years, or one year, or a day? If you don’t put a time scale in, you can claim pretty much anything you like.

For example an astronomer could attempt to shock you by stating that ‘The Earth will be hit by a big Asteroid. This is one hundred per-cent certain.’ – stunning announcement from A.N. Astronomer. Read all about it.  And of course, this is true. The Earth will be hit by a big Asteroid, sometime in the next three billion years or so. The odds ratio for this event is 1 = 100% certain. I am even willing to take a bet on it. What you probably want to know is however, is, what is the likelihood of this happening in my lifetime. Sorry, no idea.

Anyway, I hope this makes it clear that you must define risk in two ways, the possibility of the nasty thing happening, and the time period during which it is likely that the thing will happen. With lightening strikes, I would guess this is about a one in five million risk, over a five year period. Not high.

However, whilst the time factor is important, people don’t just bend statistics by ignoring the time factor. What also happens is that people inflate the risk by using relative instead of absolute risks.

For example, the chances of dying of lung cancer, for a non-smoker, are about 0.1% (lifetime risk). If, however, you live with a heavy smoker, your chances will increase to about 0.15%. (These figures are for illustration only, and are not completely accurate).

Now, you can report this in two ways. You can state that passive smoking can increase the risk of lung cancer by 0.05% – one in two thousand. Or, you can state that passive smoking increases the risk of lung cancer by fifty per cent (0.15% vs 0.1%). Both figures are correct. One is increase in absolute risk, the second the increase in relative risk.

If you are an anti-smoking zealot, then I would imagine you would prefer to highlight the second figure. The relative risk figure. And when it comes to reducing cardiovascular risk, exactly the same procedure is used (in reverse).

Let’s say that the chance of dying of CHD over the next five years, in a healthy fifty-five year-old, is 1%. By reducing this risk to 0.2%, you can claim to have reduced the relative risk of dying of CHD by 80%. The absolute risk reduction is 0.8%. Mangling statistics is easy when you know how. It’s even fun.

Anyway, now you know the difference between a relative risk and an absolute risk, and I hope this makes it easier for you to hack your way through the misinformation that spews forth from the great medical research machine.

By the way, I believe the Polypill will achieve a 0.00% absolute and relative risk reduction. But we shall see.

 

 

Data Manipulation – Gosh Really

 

Now that Ben Goldacre’s book Bad Pharma has come out, exposing the fact that much medical research is controlled by, and manipulated by, the pharmaceutical industry, I thought I should revisit a short article I wrote six years ago:

 

Gosh, Really, You Don’t Say:

Sometimes you read something of such blinding obviousness (if that is actually a word), that you wonder why anyone even bothered writing it at all. You know the sort of thing – ‘constant criticism of children does not lead to a sense of self-worth.’ ‘A centralized command economy does not create wealth for citizens.’

But the blindingly obvious can be critically important depending on who says it. I can bang on and on about the fact that medical journals have basically turned themselves into advertorials for the pharmaceutical industry, and be readily dismissed as a fringe lunatic.

However when Richard Smith, editor of the British Medical Journal (BMJ) for many years who resigned last year, says it, then it would seem that even the cosy ‘establishment’ may be starting to feel the first cold fingers of doubt creeping in. Perhaps things really have started to go too far. So read and enjoy a short section from an article in the BMJ, 21st May 2005.

Medical journals are no more than ‘an extension of the marketing arm of pharmaceutical companies’ because a large proportion of their revenue comes from drug advertisements and reprints of company funded trials, claims former BMJ editor, Richard Smith.

“Dr. Smith argues that although medical journals make a sizeable income from drug advertisements this is the least of their ‘corrupting form of dependence’ on the industry, since the advertisements are ‘there for all to see and criticize’.

“Dr Smith’s strongest criticism is levelled at the fact that journals publish clinical trials that are funded by the industry. Unlike advertisements, trials are seen by readers as the highest form of evidence, he says. Trials funded by drug companies rarely produce unfavourable results and make up between two thirds and three quarters of the trials published in key journals.

“The potential profits from reprints of such a trial can run to $1m (£0.5m; €0.8m), says Dr Smith. And it is this potential income that can have the biggest corrupting influence on a journal because many editors are charged with ensuring their journal makes a profit.

“Editors may be confronted by ‘a frighteningly stark conflict of interest’, writes Dr Smith They may be forced to choose between publishing a trial that will bring $100,000 of profit or meet their end of year budget by making a member of staff redundant.”

 

Will this article in the BMJ change anything?….. You have GOT to be joking……

And you know what changed in the last six years. You got it. Nothing.