97. NICE but Naughty – Verners' Views

So NICE has decided to go ahead with its proposal to recommend that those with a 10% risk of developing heart disease should be considered for treatment with statins. In an article in the BMJ, Professor Mark Baker, the director of the Centre for Clinical Practice at the NICE, stated that 77 people would need to take statins for 3 years for one to benefit (1). He justified this on the grounds that with blood pressure lowering drugs, 104 patients would have to be treated for one to benefit.

My initial reaction is to suggest that it is about time Mark Baker started living in the real world. In my experience, the vast majority of patients agree to take drugs on the strict understanding that it almost certainly will have an impact, which applies to them personally. If patients were actually told that there was only a one in 50 or even a one in a 100 chance that the drug would work in their case, how many would be prepared to undergo the treatment? Furthermore when the possibility of side-effects is factored into the equation, a person would have to absolutely desperate to have the treatment when the possibility of benefit is so small.

Baker’s response reminds me of the good old days in Belfast when somehow or other certain individuals had more than one vote in elections. One person was most indignant when he was accused of having 13 votes, because in reality he only had 9!!!

Surely it is time for legislation to be introduced, which will make it a mandatory requirement for the chances of success as well as the risks of side-effects to be presented to patients before agreeing to any form of drug therapy. After all it is standard practice to spell out the risks and chances of success before a person agrees to an operation so why should treatment with drugs be any different?

So to get back to the statins, let us consider what Baker does not tell us. The figures quoted only apply to those who have heart disease in the past. However when statins are used for primary prevention, which effectively is what is being proposed, there is no benefit in terms of improvement in life expectancy. Although there may be a very small benefit with respect to heart disease and strokes, this is more than outweighed by increased risks of developing diabetes and muscle damage (2). Baker also fails to mention that there is not a shred of reliable evidence to demonstrate that statins have any benefit whatsoever in women. In fact a comprehensive study conducted in Norway has found that for women from about age 60, when most deaths occur, the higher the cholesterol level the greater the life expectancy(3). The justification for using stains is primarily that they will lower cholesterol, which certainly does not make sense in the light of this information.

On side-effects Baker was incredibly complacent. He dismissed claims that GPs had reported seeing far more side effects from statins than were reported in the published trials. In his view:

“The best evidence comes from placebo controlled trials, which show similar levels of side effects in statins and in placebos”.

He went on to say:

“Muscle pain has little or nothing to do with statins, and serious complications are extremely rare.” Furthermore the claims of a multitude of side effects:

“simply aren’t true”(1).

These statements beggar belief. As Dr David Newman points out, it often takes years of post-marketing surveillance (i.e., observational) studies and case reports for dangerous side effects to emerge. It is evident that these will not be picked up during trials, which usually focus on benefits and in any case are not specifically designed to get an accurate assessment of the adverse side-effects. A particular example is the Heart Protection Study, which was conducted in 2002 with Professor Rory Collins, director of the CTT project at Oxford University, as one of the leading investigators. This study commenced with 32,000 potential participants, who appeared to meet the criteria for treatment with statins. However about 12,000 of them were removed from the study because they had difficulty tolerating or taking a statin. In the publication of the results, information was limited to 20,000 who actually took part in the trial. What this means is that those with significant side-effects were eliminated before the trial commenced (4).

In the Women’s Health Initiative, data were collected from 153,840 postmenopausal women who were clear of diabetes at the start of the investigation. During the study, 10,242 participants developed diabetes. It was found that those who were on statins were 48% more likely to contract the disease. The results applied to all types of statin medication (5). This is undoubtedly a real effect. During the past 15 years here in the UK the incidence of diabetes has approximately doubled. There must be a strong possibility that the increased usage of statins has contributed to this increase. It is a particularly serious form of ill-health, which is not usually cured by medication.

Other adverse side-effects that have been reported include depression, memory loss, confusion and erectile dysfunction (6).

The reality is that the NICE position on statins is fundamentally flawed in the sense that it totally ignores relevant information which would have a critical influence on the final recommendation. In the past I have acted as external examiner for many Ph.Ds and I have no hesitation in concluding that this report is not up to standard.

It really is time that that Jeremy Hunt and his ministerial colleagues got a grip on things. This latest NICE recommendation will cost about £50 million to implement. Any marginal benefits will undoubtedly be more than counter-balanced by the adverse side-effects. In fact the net effect may well be a further deterioration in public health. There is simply no way that this expenditure can be justified. If this is true of statins, how many other drugs are currently being prescribed regularly for which the benefits are minimal or maybe even damaging to health?

Politicians seem to be cowed into submission by the specialists in the medical world. Yet the reality is that many of the issues are relatively straight forward. People like Mark Baker must not be allowed to get away with sweeping generalizations but should be required to present a proper logical case for the decisions they reach. If the Minister is unable or unwilling to demand answers to the crucial issues then he would be well advised to initiate an independent inquiry, which should be led by a person outside the medical profession and the pharmaceutical industries. A barrister or judge might be the most suitable person for such a task.

Alternatively this could be an ideal opportunity for the Parliamentary Committee on Health to pick up the baton.

The fact is that the current situation is an absolute disgrace and until it is addressed the NHS will continue to spend money on drugs with very little benefit to patients.

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