The latest edict from the National Institute for Clinical and Health Excellence (NICE) means that virtually everyone over 50 will be recommended to go on statins. NICE recognises that 77 people will have to be treated with these drugs over a 3-year period for one person to derive any benefit (1). It is crucial to understand that most of these are individuals who are perfectly healthy: the rationale for extending the scope of those being treated is prevention rather than cure. NICE also rejects claims that there are adverse side-effects when statins are used.

It really is unbelievable that NICE should be taking this stance when the benefits are so absolutely minimal. The organisation must be living in cloud cuckoo land if it considers this decision to be reasonable and logical. If people were informed there was only one chance in 77 that they would benefit I have no doubt that that the vast majority would not agree to the treatment and that is before any consideration of side-effects. In answer to a question, a spokesman justified statin use on the grounds that with blood pressure lowering drugs, only one in 104 would benefit!

A much more realistic picture was painted by a group of medical professionals led by Sir Richard Thompson, President of the Royal College of Physicians and Dr Clare Gerada, a former chair of the Royal College of GPs (2). In a letter to NICE, copied to Jeremy Hunt, they pointed out that:

  • There is  a lack of reliable evidence to demonstrate that when statins are used for primary prevention( ie. for people who have not had heart disease) there is any reduction in all-cause mortality
  • There is sound evidence that statins do cause adverse side-effects, which include muscle pain, cognitive impairment and erectile dysfunction. A study conducted in the USA with over 150,000 middle-aged women found that those on statins had a 48% increased risk of developing diabetes compared with those on a placebo
  • As 8 out of the 12 members of the NICE committee which made the recommendation on statins have financial links with the pharmaceutical companies producing the statins, there are genuine concerns about conflicts of interest
  • In a recent survey of 511 GPs conducted by the magazine Pulse, it was found that 57% oppose the plan to lower the current 10-year risk threshold for primary prevention from 20% to 10. Only 25% would support the proposals. It was also highly significant that 55% would not personally take a statin or recommend a family member to do so, based on a 10% risk.

An analysis of the results of trials to evaluate statins, shows that most of these studies have been conducted on men. Although there are fundamental differences between men and women in the way they respond to drugs, there is no convincing evidence that statins have any beneficial effect in women.

There is evidence that pressure has been applied by drug company interests to influence the results of a Cochrane Collaboration report in order to favour the use of statins (3).

It is clear that there is a very convincing prime face case that NICE is “not fit for purpose”. In particular, there is genuine concern that it is dominated by the interests of the pharmaceutical industry. Hence drugs are being recommended which have minimal benefit and therefore public money is being wasted on drugs that are ineffective. Even worse, some patients experience side effects which are not only unpleasant but can also cause serious damage to their health.

All the indications are that this is a major scandal which ought to be tackled sooner rather than later. Recent issues including Stafford Hospital, Hillsborough and Rotherham demonstrate the inertia of the authorities to take action despite numerous warning signs. There is not the slightest doubt that there is a pressing need to examine the role of NICE and its relationship with the drug industry simply because of the evidence that I have cited here. Ideally the Ministerial team at the Department of Health should act but they are probably incapable of dealing with the modern day Sir Humphreys. However these issues could well be tackled by Parliamentary Committees, which have the power to summon witnesses and cross-examine them. I would envisage that these topics would be ideal for the Public Accounts Committee, the Health Committee and the Science and Technology Committee. It would be fascinating to watch any attempt to justify the use of stains when the number to benefit is so small. Up to now these committees have been quick to jump into action once an issue has hit the headlines. However it would certainly be preferable if they did not have to wait to be prompted from outside sources.

Recently the Parliamentary Committee on Science and Technology expressed concern about the lack of transparency of the detailed results of clinical trials conducted by pharmaceutical companies to determine the effectiveness of drugs (4). In the absence of all the available original data it is not possible to make an accurate assessment of the effectiveness of any particular drug. The full implications of this have been spelled out in a recent book by Peter Gøtzsche (5). In this he describes how Pfizer had been fined $2.3 billion in the United States for promoting off label use of four drugs, while Merck had been responsible for the deaths of thousands of patients with its deceptive behaviour around a drug for arthritis.

I will be making this information available to the various Committees in the hope that this issue will be placed on their agendas. I also intend to forward this to my MP with a request that he presses for action and I hope that other readers in the UK will also pass on to their own MP.

At the very least I would expect that all information on the odds of success and the risks of adverse side-effects should be accessible to each and every patient before agreeing to treatment with any drug. If this episode is anything to go by, I suspect that most people would be very surprised at what they learn!

REFERENCES

  1. http://www.bmj.com/content/349/bmj.g4694
  2. http://www.nice.org.uk/Media/Default/News/NICE-statin-letter.pdf
  3. http://vernerwheelock.com/?p=545
  4. http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/writev/clinicaltrials/clinicaltrials.pdf
  5. Peter Gøtzsche(2013). “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare Radcliffe Publishing London