'Conclusive' Proof Statins Are Safe and Effective

A recent study published in The Lancet has been reported (by the journal) as providing conclusive proof that statins are safe and effective in the long-term. The Lancet also produced a podcast on their website and published a commentary to accompany the study.

The results of this study, along with the associated podcast and commentary have been presented in a way that is extremely favourable to statins. However, there is an obvious fundamental flaw with this study that, in my opinion, has not been adequately discussed.

The new study relates to a follow-up of the Heart Protection Study (HPS), which was a statin clinical trial that ran for just over 5 years. At the end of this study the researchers continued to monitor the participants for a further 5 years. 

During the follow-up period, increasing numbers of people who were in the original placebo group started to take a statin. By the end of the study, the number of people taking a statin in each group was the same. 

The table below shows how many people (as a percentage) were taking a statin in each group.

 

Obviously, the study was no longer comparing a statin against a placebo – it was comparing statins against statins. Just to make it even more confusing; we do not even know which statin people took during the follow-up period and at what dosage.

This did not stop the researchers describing the results of this study as definitive evidence in favour of statins. 

Most doctors who prescribe statins will not have the time to read the full study and will have to rely on the summary and the podcast. This will leave them with an interpretation of these results that is heavily skewed in favour of statins.  

As far as I am concerned, the fact that just as many people in the placebo group took a statin is enough to nullify this study. However, there are several additional issues. 

All of the people included in this study are categorised as having very high risk. Almost half had already had a heart attack, and everyone else had either other forms of cardiovascular disease or conditions that would place them at high risk.  All of the evidence from statin clinical trials has consistently shown that any 'benefit' varies greatly according to the level of risk the trial participants have. Therefore, if any statin benefits were found during this study, it is simply unthinkable to try and extrapolate this to the general population or the majority of people who take statins.

In addition, the study report and commentary describe the results in terms of relative percentages. This is a very common problem with statin clinical trials. The relative percentage is meaningless to patients and it grossly exaggerates any suggested 'benefit'. For example, in terms of vascular related deaths a risk reduction of 18% is quoted for the initial trial period. However, the real risk reduction in absolute terms was 1.7%. 

Incidently, this 1.7% risk reduction in vascular related deaths reduced to 0.1% during the follow-up period. Therefore, there is not any real evidence to support the claim that the 'benefits' of statins increase if a person starts taking the statin earlier in life. 

It is also worth mentioning that statins have a wide range of adverse effects (some very serious) that were not included in this study. 

References:

Reuters: Cholesterol drugs safe, even after a decade of use. 23 November 2011

MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebocontrolled trial. Lancet 2002; 360:7-22

Heart Protection Study Collaborative Group. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20 536 high-risk individuals: a randomised controlled trial. ; published online Nov 23.

Kohli, P and Cannon, CP Statins and safety: can we finally be reassured?Lancet 2011;  published online Nov 23

'Healthy' People Dying After Heart Attack

Most authoritative organisations providing information about heart disease typically list several main risk factors, that they say, need to be managed in order to minimise our risk of dying from a heart attack. Hundreds of millions of dollars are spent every year educating doctors and the general public about these risk factors, such as: high blood pressure, high cholesterol, smoking, diabetes and a family history of heart disease.

However, a recent study published in the Journal of the American Medical Association, found that people who have the above risk factors are LESS likely to die after a heart attack than people who do not have the above risk factors. 

The study included more than 500,000 people who had a heart attack without any previously known  about cardiovascular disease. The researchers also accounted for other influences such as age and weight. 

In this study, the people who had NONE of the above risk factors were 50 percent MORE likely to die after a heart attack, than people with all of those risk factors. 

Some of the people who had these risk factors would have been on medications, so there is a suggestion that these medications may have prevented some of them from dying after the heart attack. In some cases this may be true, however, we know the 'benefits' of medications are all too often exaggerated, so it is impossible to say how much the medications would have influenced the results.

Of course, some of the above risk factors are valid, but overall, this study is telling us that the conventional model of how heart disease develops is fundamentally flawed. 

The conventional view of  cardiovascular disease is very narrow-minded and puts far too much emphasis on risk facts, in particular, risk factors that pharmaceutical companies have medications to treat. 

Cardiovascular disease is caused by a wide range of nutritional, lifestyle and environmental factors. The basic mechanism involves a build-up of inflammation that becomes in effect, out of control. Several nutritional factors are associated with this. Toxins can also damage our arteries. So can infections. In addition, excessive stress and a lack of social support are far more damaging to the heart than an arbitrary cholesterol reading.  This broader understanding of how cardiovascular disease develops is much more scientifically coherent than a short list of profit-driven risk factors. 

References:

Reuters News Story: More "healthy" patients die after heart attacks. November 15 2011

Canto, JG et al. Number of Coronary Heart Disease Risk Factors and Mortality in Patients With First Myocardial Infarction JAMA 2011;306(19):2120-2127

At Last, the Tide has Turned!

Statins have been in the media a lot again this week and finally at least some of the facts are starting to get out. It has all been prompted by a review conducted by the Cochrane Collaboration. This review concluded that for many people who take statins, the risks for adverse effects outweigh any benefits.

This will be of no surprise to anyone who has looked into this subject, and the media reports do not go far enough, but at least some of the issues regarding statins are now starting to reach the general public.

The news reports do not go far enough because they still suggest that cholesterol is a risk factor for heart disease. After all this time it still absolutely amazes me that so many doctors have not bothered to take even the most casual look at the evidence.

New Study Confirms Statins Cause Diabetes

The results of a new study have just been published in The Lancet. The researchers found that statins increase the risk for diabetes. This increased risk seems very small - its 0.4 percent. However, this is more significant than it may first seem.

The authors of the published report have stated that the benefits of statins still far outweigh the risks. But do they?

When looking at the 'benefits' of statins, we should look at how many lives are actually saved by the drugs. The JUPITER trial, which has recently been used to justify the wider use of statins, showed that statins reduce deaths from all-causes by only 0.55 percent.

This mere 0.55 percent reduction in deaths is not even the worse case scenario. Since other trials, such as the AFCAPS trial, the ASCOT trial, and the CARDS trial, all failed to show any significant reduction in deaths from all causes. 

Strictly speaking, deaths from all-causes is the most important measure we should use to judge the effectiveness of a drug. Since there is not much point if the drug reduces the risk for one disease but at the same time increases the risk for another disease within the same time period. But 'experts' often focus on the cardiovascular benefits of statins in order to make the drugs appear to be better than they actually are. 

Even if we do just look at cardiovascular benefits, the results are certainly nothing to shout about. The JUPITER trial mentioned above found that statins reduce the risk for ‘hard cardiac events’ (heart attack, stroke, or death from cardiovascular causes), by just 0.9 percent. 

Statins can be more effective when used by people who already have heart disease. But even here the benefits in terms of actual lives saved have been mixed. And most people who take statins are at a low risk of developing heart disease.

So, when we put the 'benefits' of statins into context we can see that this increase in diabetes is by no means trivial. Any increase in diabetes should be of concern, since diabetes drastically increases the risk for heart disease, and the full extend of these risks would not be seen during a statin clinical trial. This is because statin trials are only 2 to 6 years in duration – the full extent of the increased risks associated with diabetes develop over a much longer period of time.

And we have not included in this discussion the long list of other officially recognised adverse effects associated with statins. Or the significant questions that still remain concerning statins and cancer, and statins and heart failure.


There are no published studies to show that statins provide any benefit after 5 or 6 years, yet millions of people are being asked to take the drugs for several decades. The best case scenario is that any net benefit associated with statins hangs on a knife edge. Despite this, in the UK alone, we spend hundreds of millions of pounds on these drugs every year. 


There is no need for pharmaceutical companies to worry about the increased risk for diabetes associated with statins, since they have other (equally ineffective) drugs for that as well.


Note: I have used absolute percentages for this discussion. In most cases, relative percentages are used in summary reports and throughout the media. All text books on clinical research advise against the use of relative percentages in this context since relative percentages are totally misleading and do not allow people to make accurate comparisons of risk.


Reference:
Sattar N, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; DOI:10.1016/S0140-6736(09)61965-6