CTT the house of statin secrets - Burne

SOS: Sanity over Statins – CTT the house of statin secrets

by Jerome Burne

Should a professional body, however eminent, be allowed to keep information about the safety of products they are supplying to public hidden so no one else can run tests on them?

That is the question raised by HealthInsightUK’s finding that a large and respected organisation whose job it is to analyses the findings of statin trials – The Cholesterol Treatment Trialists’ (CTT) Collaboration in Oxford – has an agreement to keep secret much of the information contained in its huge database which holds results from 27 trials of these drugs, nearly each of which was run by a drug company.

Questions about the secrecy of the CTT have been put in the spotlight following the recent recommendation by NICE to change the guidelines on statins. If the proposals are accepted, millions more healthy people in the UK who have no sign of heart disease will be prescribed these drugs. A key part of the evidence supporting this proposal was a study by CTT published in the Lancet in 2012.

HealthInsightUK has also established that the CTT do not hold data on the side-effects of statins. A spokesman confirmed that they base their estimate of risk on the published results of trials conducted by the drug companies. He dismissed claims that side-effects such as muscle pain and depression were wide spread, saying they were only “hypotheses”.

Denied access to data

This could explain why the CTT has regularly reported a much lower rate of side-effects than trials run by independent researchers. Knowing the true rate of side-effects is particularly important with statins because many patients have to take them for one to benefit. If the estimate of side effects is too low the benefits may not outweigh the risks.

Concern about the secrecy surrounding CTT’s data is not new. Dr Jim Wright editor of the highly respected and independent journal Canadian Therapeutics Initiative which analyses drug studies has described how several years ago he had tried and failed to get access to statin data held by CTT.
“They had agreed someone from my team could have access to their data, although the researcher would have to go to Oxford to see it. However after travelling 6000 miles, they were told that the data was not available.”

This is just an anecdote but many others have since reported the same thing. The latest concern about access to CTT data was triggered last year when the Cochrane Collaboration – famed for its rigorous assessment of the benefit of drugs and other treatments – produced a report saying that statins should be more widely used on people without heart disease. The report was heavily based on the CTT Lancet study. Was it actually possible to check their findings?

Everyone wanted the data

A number of senior researchers approached by HealthInsight have supported Dr Wright’s claim that the data held by CTT hasn’t been available. Professor Rita Redberg cardiologist and editor of the journal JAMA Internal Medicine, has stated in an email that: “CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins. The CTT data is not accessible publicly.”

“I have not requested access to the CTT data,’ says Dr David H. Newman, Director of Clinical Research, Mount Sinai School of Medicine, New York.

‘However, I’m not aware of anyone who has gained access to these data, which speaks volumes since everyone has wanted it. For the science to be considered even potentially credible, another independent group will have to replicate their analysis.”

Professor Harriet Rosenberg of the Health and Society Program at York University in Toronto commented that: “many scholars have asked the CTT for data without success” in a formal reply to the Cochrane review last year.

The response by the CTT when such individual claims are made is to say that anyone with a well formulated proposal can get access to their data. But emails seen byHeathinsightUK throw doubt on that. They were exchanged between one of CTT’s top researchers Professor Colin Baigent and an Australian TV journalist researching a story about statins.
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Alzheimer’s: another reason to be sceptical about statins - Burne

Alzheimer’s: another reason to be sceptical about statins

November 5, 2012 By Jerome Burne

 

The front page of the Daily Express on Friday led with a new warning about statins – combining them with certain blood pressure pills could raise your risk of muscle pains, lung disorders and kidney damage. Hmm yes well.

Even as a cholesterol/statin sceptic I thought that was remarkably over-hyped – statin side effects are massively underplayed and finding they go up a bit when mixed with another drug is more of a clinical technicality than front page news.

However there is a statin risk which should be a serious cause for concern – lowering cholesterol may well raise your chances of developing Alzheimer’s. I’ll come to that in a moment.
First there is one aspect of the Express story that raises a wider issue – the way the buck is subtly passed when any new risk factor is identified. The standard official response is is to say: “If you are worried discuss it with your doctor.” It seems sensible but the implications aren’t reassuring. It’s a line that’s been trotted out rather a lot recently.

Need for serious sanctions

Earlier this week it was used in response to the report that found that more women are harmed by unnecessary treatment following a mammograms than benefit from detecting a cancer. The week before, when a brilliant BMJ investigation exposed the appalling corruption involved in official EU licensing of hip implants, you were also invited to discuss how it might affect you. In both cases serious sanctions would seem appropriate.

In the case of mammograms because convincing research showing that the dangers of over-diagnosis from breast screening dates back over a decade. A clear statement of risks and benefits has taken so long because of the readiness of the mammogram establishment to ignore or denigrate evidence of harm, as I described recently in the Mail. The fact that the European Medicines Agency allows licensing bodies to behave in a way that openly favours business interests rather than the patient, should also trigger an investigation.

Shifting responsibility

There’s nothing wrong with discussing safety with your doctor, but when that’s all that happens it is a brilliant way of shifting the responsibility for producing safe products from the authorities onto you. If in the future you suffer as a result of mammograms or hip implants or indeed statins then the fact you were told about the risk, discussed it and went ahead becomes just one of those things. For a book that discusses this see here.

To appreciate how odd the response to medical dangers is, look at what happens with when something dangerous about a car is picked up. In 2010 it was found that the throttle on some Toyotas could stick in the open position. But rather than saying: “If you are worried about the “dangerous acceleration” issue, discuss it with your dealer and decide if Toyota is right for you”, the company recalled nine million cars.

The truth is that medicine is far more dangerous than the motoring. An estimated 15 people died from driving 10 million cars at risk from the acceleration issue in the USA. If all drugs and other conventional treatments had to be withdrawn at that level of mortality, medicine would become impossible.

Drugs carry serious risks because of the way they work. A single molecule, such as cholesterol that is part of a complex interlocking system, is blocked or boosted with a drug – statins. Inevitably they do things you don’t want as well as the ones you do. And the more important the system you are blocking the more likely the harm. That’s why statins could cause the sort of brain damage that shows up in Alzheimer’s.

Last week I wrote about the growing evidence for links between the raised insulin and insulin resistance that diabetics suffer from and an increased risk of Alzheimer’s. What I didn’t appreciate then was that lowering cholesterol might be equally damaging.

You may be familiar with the idea that cholesterol is involved in brain function but maybe not just how important its role is. A review article in the European Journal of Internal Medicine last year makes it clear.

Cholesterol’s vital role

“The brain represents only 2% of the body’s total mass, but contains 25% of the total cholesterol,” reads an introductory paragraph. “Cholesterol is required everywhere in the brain as an antioxidant, an electrical insulator (in order to prevent ion leakage), as a structural scaffold for the neural network, and a functional component of all membranes. Cholesterol is also utilized in the wrapping and synaptic delivery of the neurotransmitters. It also plays an important role in the formation and functioning of synapses in the brain.”

Personally I’d want to know my odds of benefiting from blocking something that vital were better than the 100 -200:1 that is on offer from stains for primary prevention. The article goes on to describe a number of specific ways cholesterol is used in the brain.

It’s directly involved in the action of a gene known as ApoE. A harmful variation – ApoE4 – is well known to raised your risk of both heart disease and Alzheimer’s . So what does ApoE do? “It has an essential role in the delivery of fat, cholesterol, and antioxidants from the liver to all the cells of the body,” writes the author Stephanie Seneff, a Senior Research Scientist in the Computer Science and Artficial Intelligence Laboratory at MIT who has recently been turning her attention to biochemistry and medicine.

The ApoE4 variation causes brain problems because it doesn’t work so well and lowers the amount of cholesterol available to the hippocampus – the brain region crucial for memory.

More evidence for the harm from having too little cholesterol comes from research showing that Alzheimer’s patients have low levels of cholesterol in their spinal fluid, along with not enough lipoproteins, triglycerides, and free fatty acids. Parkinson’s patients, who also suffer brain damage, have low levels of cholesterol in their blood.

There’s still a lot more to be done to prove definitively that too too little cholesterol damages the brain along with too much insulin and glucose.But avoiding these two highly plausible risk factors is remarkably simple and doesn’t involve adding new risks the way drugs do. It’s what we advocate in our book. Make sure you have enough good fats and eat foods that don’t push up blood sugar.

It’s what Dr Seneff’s recommends too. “Simple dietary modification, towards fewer highly-processed carbohydrates and relatively more fats and cholesterol, is likely a protective measure against Alzheimer’s disease.”
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Statins: why you should think twice - Jerome Burne

Great Review of $TATIN NATION by Award-Winning medical Journalist Jerome Burne:http://jeromeburne.com/2012/09/08/statins-why-you-should-think-twice/

Statins: why you should think twice

 

September 8, 2012 By Jerome Burne

 

If you’re over 45 there’s a good chance that you are taking or have at least been offered a statin drug to lower your cholesterol and so cut your risk of heart disease but is it good idea? Your doctor obviously thinks it is, but there is another side to the statin story. The link between cholesterol and heart disease is not as strong or as simple as the familiar statin story suggests.

For instance, the UK is quite high in the international heart attack league table but on a table ranking countries average cholesterol level, it’s quite far down. If high cholesterol equalled high heart attack risk, the two should match. What’s more the number of people in the UK with high cholesterol has been falling for several decades but during that time the rate of heart attacks has been flatlining. Likewise you’d expect the two to come down together.

And there are more examples where the population-wide figures don’t match the theory. One big study found that the average cholesterol level of over 100,000 people admitted to hospital in the States with a heart attack was actually lower than the level in the general population.

High risk but low cholesterol

Or this one: your social class is one of the best predictors of your risk of a heart attack – if you’re a fairly well off ABC1 it’s much lower than if you’re a poorer C2, D or E. There are all sorts of reasons for this – diet, access to information etc – but if cholesterol was a key factor you’d expect the As to have low levels and C2s to be high. Actually it is the other way around.

These are just a few of the points made in a very watchable new video called $tatin Nation which combines interviews with a number of cholesterol sceptical doctors and researchers with clips and strong graphics. By the end, at the very least, you are going to have a lot more questions to ask your doctor.

The video come at a time when the debate over statins is hotting up. In the last couple of years several large trials have concluded that if you are healthy, but just have some risk factors – being over 55 is one – then statin benefits are vanishingly small.

Give them to everyone

But in the last few weeks, two more big studies have come out claiming that statins are safe and well-worth taking whatever your cholesterol level. Their message is that giving them to everyone over 55 would greatly cut premature heart disease deaths saving the NHS billions.

So what to do? The case for statins is available on every official website about heart disease while sceptical case is spread across dozens of sites. $tatin Nation saves you an impossible hunt by summarising the sceptical case in one place. It’s worth finding out what it is.

Here are a few more pointers from the video. You might ask: how come lots of reports say statins cut the risk of heart disease by 30%, 40% even 50%. How can that be bad? The short answer is clever marketing and a nifty way with statistics. Here’s how it works.

A couple of years ago a statin trial called Jupiter came out with a remarkable result: statins cut the chance of a heart attack by 54%. To understand why that is not exactly a lie but is astoundingly misleading, you have to look deeper into the results than the drug company’s own summary – the one used by nearly all the newspaper and media reports – which is where the 54% figure came from.

3/1000 chance

What you are interested in is the difference between those getting the drug and those getting a placebo. This shows that 0.35% of those taking statins had a heart attack compared with 0.7 of those on a placebo. In other words, out of 1000 people who had no treatment. 7 had a heart attack.

There were certainly fewer heart attacks in the statin group – only 3.5 people out of 1000 had one. Now that is a 54% improvement, so no lies are being told, but it means that a thousand people have to take statins for just three to avoid a heart attack. Taking statins does seem less appealing doesn’t it?
And then there are the side-effects such as diabetes which showed up as a risk in the Jupiter trial. The figures aren’t precise but there could be one extra case of diabetes for every 200 people on the drug.
That’s not far off the number who can expect to benefit.

But diabetes isn’t the only possibly side effect. There is a frightening section in the film where patients describe the range of nasty effects linked with statins – muscle pain is by far the most common, other include fatigue, memory loss and brain fog. A common theme is how uninterested and unhelpful doctors are when told about them.

Several of the experts estimate that between 10% and 20% of patients suffer some sort of side-effect. That’s 100 to 200 people having unpleasant or possibly disabling symptoms for every three people who avoid a heart attack.

There’s lots more in $tatin Nation, such as clear links between stress, loneliness and heart disease that has been largely side-lined by the heavy concentration on cholesterol lowering. And then there is CoQ10, an enzyme and anti-oxidant called CoQ10 that’s vital for energy production in both the muscles and in the heart. As well as cutting cholesterol production, statins also cut CoQ10 production.

Do have a look at it.
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