How NICE got snookered on statins

8 million people in Britain are on statins and the National Institute for Clinical Excellence (NICE), who advise GPs what to do, recommend another 5 million should be based largely on the evidence of a one research group called the Cholesterol Treatment Trialists. But are they are a mouthpiece for promoting big pharma’s interests?

When I first read the Cholesterol Treatment Trialists (CTT) meta-analysis, published in the Lancet last year I was deeply suspicious. Somehow they had managed to jiggle the statistics to imply that the overall risk of death and cardiovascular events (heart attack and stroke) were lower in low risk individuals taking statins, (with minimal risk) and came with minimal side effects. The message was that you didn’t even need to have high cholesterol to benefit from statins. This CTT meta-analysis is the main data that then influenced NICE.

Now, it emerges, their calculation is theoretical, not actual, and far from reducing death rate, the most statins do is a tiny extension of life in a tiny number of people. If 10 million people took a statin, 500 (0.5%) would live three months longer. However, this was promoted in a press release as “50,000 lives saved each year… that’s a thousand a week.” It would have been more accurate to say 99.5% will have no benefit.

But it gets worse because the CTT group pretty much ignore the common side-effects which affect up to 20% of people on statins, and can be pretty devastating, ranging from tiredness, muscle aches to impotence, amnesia and increased diabetes risk. So, if another 5 million people at low risk for heart disease take statins, 1 million will be pitching up in GPs surgeries complaining of side-effects, and consuming NHS time and money.

Another big objection from heart disease experts is that the CTT raw data has not been made available to other researchers to check their statistics and assumptions. Transparency is a goal of modern medical science and the CTT group fall far short. The data, of course, comes from drug company funded trials but just how much data was passed across to CTT is the issue. Often, drug companies limit access to adverse effect data, and are selective in what they give, as was the case with Roche and Tamiflu. Now, in turns out, drug companies made their data available to CTT, excluding data on side-effects, apparently on the condition that they did not disclose the data to third parties, according to a recent report. This explains why CTT pretty much ignore side-effects, referring to them as hypothetical in press interviews, and have so far refused to share their data with other medical experts. In fact, a group of medical experts have complained, and critiqued this very fact in a report soon to be published in the British Medical Journal. Meanwhile, there’s a lot of sniffing around to discover the true sources of bias and funding of the CTT members. For the main spokesman for the group, Professor Colin Baigent, conflict of interests include Astra Zeneca, Merck, Sharp & Dohme, GSK and Johnson & Johnson.

The reason dissecting the CTT analysis is so important is that the Cochrane Collaboration – a respected group that produces reports to guide clinicians about what treatments are worth it and which not and who are known for chasing up raw data – did a complete U-turn on statins, based on the CTT data. In 2011 the Cochrane Collaboration were very critical of giving statins to primary patients because there was little evidence of benefit. Yet, this year a revised Cochrane review, based largely on the CTT data, now says they are, seemingly ignoring their previous position. Also, the Cochrane Collaboration seemed to just accept the CTT analysis without chasing up the raw data, which is very unlike them. Their report then influenced NICE and led to the current draft recommendations to astatinate millons more people, which will become official in the next few weeks unless NICE can be persuaded that something is remiss.

The CTT, and now NICE, continue to propound the myth that it is all about cholesterol, and the lower you can get it the better. They ignore other risk factors for heart disease, such as homocysteine, which is a better predictor of cardiovascular death among older people than cholesterol, and claim that the reduction that has occurred in heart disease is all down to statins without the evidence to support it. It is also the case that a number of experts including the two American cardiology societies who produced a report recently, believe that low cholesterol does not translate into lower risk. In fact one big study found that more people arriving in hospital with a heart attack had lower than normal cholesterol.

My main objection to statins, apart from the obvious political manoeuvrings to pull the wool over NICE’s, doctors’ and patients’ eyes to keep the money rolling in for big pharma, is that this approach continues to belittle people taking responsibility for the true causes of heart disease, and almost every other modern day killer disease, which is diet and lifestyle. Watch my film Prevention is Better than Drugs to see the big picture. If you really want to reduce your risk for heart disease read Say No to Heart Disease. It isn’t difficult to do with a few obvious diet and lifestyle changes.

The best blogs I’ve read on the CTT/NICE cholesterol debacle are by Dr John Briffa Dr Malcolm Kendrick and Zoe Harcombe ‘Statins: just say no. Sensible reasons why they are stupid medicine.’ and Jerome Burne’s SOS Sanity over statins: CTT The House of Statin Secrets