Total Pageviews

Monday, 10 November 2014

Statins: Conflicts of interest NICE should be independently investigated

Rt Honourable Sarah Wollaston, MP


NICE should be independently investigated in relation to its systems designed to deal with conflicts of interest of its Guideline Development Group Pan

Dear Sarah,

We write to you as the Chair of the Health Select Committee to seek the Committee’s views on what we believe are serious shortcomings in the National Institute of Health and Care Excellence’s evaluation processes, which has resulted in the recommendation to offer statin medications to those at low risk of cardiovascular disease. We have particular concerns in relation to the management of conflicts of interest of the Guideline Development Group panels, and apparent systemic weaknesses which the Institute appears to have no appetite to address. We are concerned that the system of recruitment, appointment and the monitoring of conflicts of interest of Panels is not fit for purpose. 

We feel that Professor David Haslam has failed to adequately address crucial points from a letter previously written by a number of us on the subject of the medicalisation of 5 million healthy individuals, potential conflicts of interest, industry bias, hidden data and loss of professional confidence. Professor Haslam’s letter is attached.

The medicalisation of 5 million healthy individuals

Professor Haslam mentions that “the [NICE] independent guideline group has carefully considered benefits and harms (of statins) in a systematic way with modelling to explore areas of uncertainty” and that the group was able to reach the conclusion that the “benefits outweigh the harms and that statins are clinically and cost effective for people with a CV risk of 10% or over”. 

He says that the “potential sizeable increase in the number of people who might take statins as a result of this guidance [that] the potential costs to the NHS may be lower than in 2012 due to a reduction in their price”
However, a paper published in the BMJ which underwent further analysis – both groups being independent of industry conflicts, concludes that statins do not reduce overall mortality or serious illness in those with a 10% risk of CVD.
1 We therefore find it unhelpful that NICE’s director of clinical practice, Professor Mark Baker uses such emotive language when describing the benefits of statins,
conflating the effects of heart disease as a condition which “kills, maims and destroys lives” in the same context as prescribing statins to those at low risk. In our view, this could be perceived as scaremongering and persuading people to take statins when the evidence does not clearly support this statement. The public might expect better from NICE. 

Potential conflicts of interests

He states that he is “very concerned that (NICE) guidance should carry the support of the professions” but appears to have not acknowledged the views of representative organisations of UK Doctors –namely the British Medical Association and the Conference of Local Medical Committees, both in terms of grave concerns in regards to access to the raw data and perhaps more importantly conflicts of interest within NICE’s guideline development groups.

We continue to be concerned about the ‘independence’ of this guideline group in particular where 8 of 12 members had direct financial ties to the companies that manufacture statins. Indeed paradoxically disclosure of a conflict can increase the bias in advice, because it may expose advisors to “moral hazard”, feeling licenced and strategically encouraged to emphasise their advice even further. As a result, disclosure may fail to solve the problems created by conflicts of interest and may sometimes even make matters worse.2

Transparency is important but accuracy and objectivity should be the gold standard expected of an independent panel. It has recently come to light that one member withdrew or resigned (it is not clear) from the panel during the period of evaluation due to an issue of conflict of interest. It is not 
possible to understand from published information or reports in the Press what systems failures may have occurred in this particular case from which lessons might be learned. Indeed there does not appear to be any acknowledgment by NICE that any failure occurred.

The BMA takes the issue of potential conflicts of interest very seriously. At the recent ARM (June 23rd 2014) the following motion was passed with overwhelming support. “That this meeting believes in any advisory committee of NICE ,when guidance on any drug is issued, must be made clear that none of the members must have a financial interest in pharmaceutical companies which 
manufacture the drug”


No comments: