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Tuesday, September 30, 2014

WEIGHING UP THE EVIDENCE ON STATINS - Dr Verner Wheelock

WEIGHING UP THE EVIDENCE ON STATINS

Statins are certainly in the news these days. NICE has put forward proposals that all those with a 10% risk of developing heart disease should be treated with statins. Effectively this means that everyone over the age of 50 years, including those who are fit and healthy, would be expected to have the treatment. On the other hand this strategy is being questioned by many within the medical profession. In this blog I will try to tease out the information which individuals need in order to make a sound judgment on whether or not to go on statins.
 
Essentially people need to know if they will derive any benefit from the statins which will have to be balanced against the type, frequency and severity of any side-effects.
 
According to Professor Sir Rory Collins, from Oxford University, GPs and the public are being made unjustifiably suspicious of the drug, creating a situation that has echoes of the MMR vaccine controversy(1). Collins is the leader of the Cholesterol Treatment Trialists’ (CTT) Collaboration which has been analysing data on the effects of statins which has been supplied to them by the drug companies. In their latest report it was claimed that statins significantly reduced major cardiovascular events and all-cause mortality in people at low risk (2). The results of this trial were a critical factor influencing the position taken by NICE.
 
This is somewhat surprising because other studies have concluded that statins are not beneficial to people at low risk. It is also highly relevant that the CTT study has been subject to severe criticisms.
In an exercise of this kind one would expect the investigators to compare the results of those who had been treated with statins with those of a control, consisting of a similar group of people who had not been treated. When this approach has been used, others have not been able to find that there were any appreciable benefits in the statin group. For example, Ray and co-workers analysed the results of 11 clinical trials involving 65,229 participants with approximately 244,000 person-years of follow-up and 2793 deaths (3). All of these individuals were high risk but without previous cardiovascular disease. Over an average treatment period of 3.7 years the use of statin therapy did not result in any reduction in all-cause mortality.
 
By contrast the CTT group has adopted a totally different approach which has been explained by Dr David Newman in an article on his blog (4). Instead of comparing those who were treated with statins with the controls, they selected those individuals in which the statin treatment reduced the LDL Cholesterol 1 mmol/L or 40 points in US terms. As Dr Newman describes it:
 
“…they shifted the data so that their numbers corresponded precisely to patients whose cholesterol responded perfectly.”
 
He goes on:
“Patients whose cholesterol drops 40 points are different than others, and not just because their body had an ideal response to the drug. They may also be taking the drug more regularly, and more motivated. Or they may be exercising more, or eating right, and more health conscious than other patients. So it should be no surprise that this analysis comes up with different numbers than a simple comparison of statins versus placebo pills. Ultimately, then, this new information tells us little or nothing about the benefits someone might expect if they take a statin. Instead it tells us the average benefits among those who had a 40-point drop in LDL.”
 
Furthermore the LDL Cholesterol drop cannot be predicted because the effect of the statins is unknown. This means that the conclusions of this analysis have absolutely no relevance to patients and doctors who have to decide if statins should be prescribed.
Here is a final quote from Dr Newman:
 
“Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story.”
 
But it does not stop here because the CTT also argued that the side-effects of the statin treatments are relatively small. Rhabdomolysis, which is the catastrophic breakdown of muscle tissue, has an excess incidence of about 0.1 per 1000 over 5 years according to CTT calculations. However Dr Malcolm Kendrick, author of “The Great Cholesterol Con” refers to a study conducted in the USA, which analysed data on statin side-effects recorded on the FDA’s Medwatch. Between July 2005 and March 2011 there were 186,796 case reports of which 8,111 were due to rhabdomolysis. This equates to 811 deaths over this period. As it is accepted that reporting rates are extremely low, this figure can be multiplied by a factor of 10 or even 100 to obtain the true value (5). If precedents were followed up this evidence should be more than enough to have the drugs withdrawn.
 
The CTT authors reported a 10% increase in the relative risk of developing diabetes while on statins. This equates to 5 new cases per 1000 people treated for 5 years. However other studies have reported values of up to 50% more (6).
 
Uffe Ravnskov is an independent researcher in Sweden who has suggested that if you are a healthy person who is being advised to go on statins then this is what you should be told before going ahead (7):
 
Your chance not to get a non-fatal heart event during the next five years ……is 97.1 per cent. You can increase your chance to 98.1 per cent if you take a statin every day. But then your risk of suffering muscle problems is about 25 per cent unless you never exercise (1); your risk of becoming sexually impotent is about 20 per cent (2); your risk of suffering from diabetes is about 4 per cent (3), and you also run a risk of memory loss, liver damage, peripheral neuropathy, cataract, and cancer, but we do not yet know how large these risks are. And don´t forget that many non-fatal heart events may heal with minor health consequences or none at all.”
 
The picture now becomes very clear. The positive results which have been claimed for the CTT study have only been obtained by manipulating the data. Unfortunately this is typical of how the modern pharmaceutical industry functions. It hypes up the benefits and plays down the undesirable side-effects. This is a particularly bad example because the leader of the CTT is a knighted professor from the prestigious University of Oxford. Nevertheless the case which they present should be subject to rigorous examination. It is extremely regrettable that NICE has allowed itself to be taken in by what can only be described as rubbish!
 
There is no doubt that there is growing awareness that the case in support of statins is full of holes. To-day in The Daily Telegraph there is an article by Haroun Gajraj, a vascular surgeon, no less, who decided to stop his treatment with statins. After looking more closely at the research, he concluded that statins were not going to prevent a heart attack and that his cholesterol levels were all but irrelevant. He also draws attention to a recent survey by Pulse magazine, which found that six out of 10 GPs opposed the draft proposal to lower the risk level at which patients are prescribed statins. As many as  55% said they would not take statins themselves or recommend them to a relative, based on the proposed new guidelines(8).
 
REFERENCES
  1. http://www.theguardian.com/society/2014/mar/21/-sp-doctors-fears-over-statins-may-cost-lives-says-top-medical-researcher
  2. CTT (2012) Lancet 380 pp 581-590.
  3. http://archinte.jamanetwork.com/article.aspx?articleid=416105
  4. http://cardiobrief.org/2012/05/27/guest-post-data-drugs-and-deception-a-true-story/
  5. http://drmalcolmkendrick.org/tag/rhabdomyolysis/
  6. http://www.abc.net.au/catalyst/heartofthematter/download/StatinsshouldNOTbebroadedtowiderpopulation.pdf
  7. http://www.bmj.com/content/348/bmj.g280?tab=responses
  8. http://www.telegraph.co.uk/health/10717431/Why-Ive-ditched-statins-for-good.html
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