Safety Or Efficacy

 

THE REAL DANGER OF STATINS

How effective is statin treatment?

Many critics of statin use claim that Statins do not work or at least that they have only a tiny effect on reduction in fatal and non-fatal heart attacks and strokes. The highest level of efficacy claimed in the Lancet meta study published in September 2016 which combined the results of 27 clinical trials each lasting for between 2 and six years and measuring the effect of statin treatment on around 105,000 participants was as follows:

  1. Delaying deaths from cardiovascular disease by 12% over a period of 5 years treatment.

  2. Delaying or avoiding Major vascular Events such as non-fatal heart attacks and strokes or the need for medical procedures to open blocked arteries by 21% over five years of treatment.

  3. Delaying death from any cause by 9% over a period of 5 years.

  4. While this does sounds like a worthwhile achievement it does not translate into a significant efficacy because it is presented in a manner which exaggerates its effect. The actual number of deaths delayed out of 100 people treated with statins for five years turns out to be just about 1 person whether the individual dies from a heart attack or stroke or indeed from any cause at all. As for major vascular events, which combine delayed non-fatal heart attacks or strokes or the need for medical procedures that is about 4 fewer events per 100 treated for five years.

Generally the authorities talk in terms of lives saved or non-fatal strokes avoided but that is not a truthful representation because of course the few who escape death or a heart attack merely suffer from the event later and the most disappointing aspect of this temporary relief is that the authorities cannot tell us how long it lasts. Independent researchers who have made a limited study of the minimal information available from the drug companies suggest that on average the lucky ones may survive for a couple of weeks longer after 5 years of treatment. Thus an individual who is trying to measure the effect of statins might have in his case can count on no more than a 1 in 100 chance of staying alive for what is in any event an unknown period while another person may have have a 1 in 50 chance of avoiding a nonfatal heart attack or stroke, again for an unknown period.

All of the above information applies to so-called primary care treatment which means that the individual concerned does not have proven heart disease before starting statin treatment. That person is treated because he or she has certain risk factors. Secondary care which is treating people who already have proven heart disease produces a better result which is perhaps twice as good as the result for primary care but still somewhat disappointing at perhaps a 1 in 25 chance of survival for an unknown period after 5years of treatment.

Of course if the period of survival or avoidance of an adverse event was better understood some individuals might accept that a 1% chance of some additional survival or a 1 in 25 chance of postponing a heart attack or a medical procedure might be worthwhile but it would surely depend on there being no chance of suffering a side effect of taking statins which had a much higher chance of causing severe illness than the improved survival benefit.

It is in this regard that we come to face the real danger of statins and where we find ourselves trapped in a dispute between the advocates of statin use and their critics. The question is are statin side effects real or imagined. Are the small levels of benefit claimed for statin use more than offset by harmful and widespread side effects already encountered or perhaps not yet fully apparent. How can we find the answer.

Are statins safe? What is the incidence and severity of side effects.

It depends on who you believe. The organisation which oversees the clinical trial results for and on behalf of the pharmaceutical companies is the Clinical Trial Service Unit (CTSU) based in Oxford and headed by Professor Sir Rory Collins. Professor Collins is adamant in his belief that the statins are both safe and effective. Perhaps the best way to communicate the opinions of the professor and the members of the organisation which he oversees is to quote directly from the Lancet meta study report (1) which is now the overriding source of information from the clinical trials carried out over a period of fifteen to twenty years on which the claimed safety and efficacy of statins is based.

 

Here are some of the relevant remarks under the heading 'Risks' on the opening page:

The only serious adverse events that have been shown to be caused by long-term statin therapy—ie, adverse effects of the statin—are myopathy (defined as muscle pain or weakness combined with large increases in blood concentrations of creatine kinase), new-onset diabetes mellitus, and, probably, haemorrhagic stroke. Typically, treatment of 10 000 patients for 5 years with an effective regimen (eg, atorvastatin 40 mg daily) would cause about 5 cases of myopathy (one of which might progress, if the statin therapy is not stopped, to the more severe condition of rhabdomyolysis), 50–100 new cases of diabetes, and 5–10 haemorrhagic strokes. However, any adverse impact of these side-effects on major vascular events has already been taken into account in the estimates of the absolute benefits. Statin therapy may cause symptomatic adverse events (eg, muscle pain or weakness) in up to about  50–100 patients (ie, 0·5–1·0% absolute harm) per 10 000 treated for 5 years. However, placebo-controlled randomised trials have shown definitively that almost all of the symptomatic adverse events that are attributed to statin therapy in routine practice are not actually caused by it (ie, they represent misattribution). The large-scale evidence available from randomised trials also indicates that it is unlikely that large absolute excesses in other serious adverse events still await discovery. Consequently, any further findings that emerge about the effects of statin therapy would not be expected to alter materially the balance of benefits and harms. It is, therefore, of concern that exaggerated claims about side-effect rates with statin therapy may be responsible for its under-use among individuals at increased risk of cardiovascular events. For, whereas the rare cases of myopathy and any muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.

 

One can see from reading this extract that Professor Collins is in no mood to accept any disagreement with the views of the CTSU and indeed why would anyone wish to criticise the report of an organisation replete with highly qualified doctors and medical researchers who are simply reporting their findings from a series of trials carried out over a lengthy period of years.

Nevertheless there are many severe critics and it can be said that they are at odds with the report for a number of reasons. I have listed some of these below

 

  1. Doctors who dispense these drugs to millions of members of the public encounter large numbers of individuals who claim that they suffer painful and debilitating side effects.

  2. Many independent groups of researchers have carried out their own assessments of some independent trials and arrived at very different conclusions from those in the Lancet report. For example, in a survey carried out in March 2013 published in the Annals of Internal Medicine, researchers tracked more than 100,000 statin users for nine years. During the study, 17% of those treated reported side effects. (2)

  3. A recent issue of the Times reported that “Doctors give statins to only one fifth of those who qualify. As we have seen the Lancet report suggests that this is due to false claims of adverse effects by uninformed opponents and imagined or misattributed adverse effects. A more plausible explanation is that the adverse effects are more common and more troublesome than they are reported to be.

  4. The mechanism which operates to reduce the amount of cholesterol produced in cells also reduces the production of other biochemical associated with cell energy and cell division. The absence of these chemicals leads in many cases to the death of As the human body is composed of around 40 trillion cells it is evident that some consequences cell deaths will only become manifest over many years of statin use and many researchers have argued that earlier consequences of cell deaths have not been yet been noticed because they have been evident and have not been looked for.

  5. Individual scientists and scientific groups have produced papers and published books reporting a range of negative health effects ranging from memory loss and impotence to increased incidences of cancer and diabetes. These adverse effects if they are indeed a consequence of increased cell death will become more apparent with the passage of time. There are however various tests which can detect cell damage and death at an earlier stage if it is present.

 

One thing is clear from the disposition of the conflicting sides in this dispute. It cannot and will not be resolved by agreement between the parties who are so fundamentally opposed in their views. Nor is there any prospect of an adjudication by some expert authority of who is in the right and who is in the wrong. Thus the carrying out of an independent retrospective study of the state of health and survival of statin takers as compared with matched none statin takers would appears to be the only means of resolving the dispute in the interests of the health and well-being of the nation.     
 

References

  1. http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(16)31357-5.pdf

2. http://annals.org/aim/article/1671708/ discontinuation-statins more than half stop one fifth symptoms

@2018 by The Statin Controversy