Kendrick and colleagues also wrote to NICE about their guidelines (specifically in relation to cardiovascular risk), the poor scientific basis for drug recommendations and the lack of transparency with regard to conflicts of interest on the panel.
This is good news for the medical profession and the population of the UK. Journalists don't investigate or challenge poor science or corruption in government and individual patients cannot achieve much alone. I've reproduced the introduction and main headings plus part of one section. It's worth reading the whole blog post:
Letter sent to NICE:
Concerns about the latest NICE draft guidance on statins
Introduction:
We are concerned about your draft guidance on CV risk for discussion and debate. We would ask for a delay until our concerns are addressed. Whilst we agree with much of the guidance, our concerns focus on six key areas:medicalization of healthy individuals, true levels of adverse events, hidden data, industry bias, loss of professional confidence, and conflicts of interest
The draft guidance recommends offering statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.
1. Medicalisation of five million healthy individuals.
2. Conflicting levels of adverse events
Furthermore, the rate of adverse effects in the statin and placebo arms of all the trials has been almost identical. Exact comparison between trials is not possible, due to lack of complete data, and various measures of adverse effects are used, in different ways. However, here is a short selection of major statins studies.
AFCAPS/TEXCAPS: Total adverse effects losartan 13.6%: Placebo 13.8%
4S: Total adverse effect simvastatin 6%: Placebo 6%
CARDS: Total adverse effects atorvastatin 25%: Placebo 24%
HPS: Discontinuation rates simvastatin 4.5%: Placebo 5.1%
METEOR: Total adverse effects rosuvastatin 83.3%: Placebo 80.4%
LIPID: Total adverse effects 3.2% Pravastatin: Placebo 2.7%
JUPITER: Discontinuation rate of drug 25% Rosuvastatin 25% placebo. Serious Adverse events 15.% Rosuvastatin 15.5% placebo
WOSCOPS: Total adverse effects. Pravastatin 7.8%: Placebo 7.0%
Curiously, the adverse effect rate of the statin, it is always very similar to that of placebo. However, placebo adverse effect rates range from 2.7% to 80.4%, a thirty fold difference.
3. Hidden data
4. Industry biasImportant findings from some other non-industry sponsored studies
5. Loss of professional confidence
6. Conflicts of Interest (real and perceived)
Yours Sincerely
Sir Richard Thompson, President of the Royal College of Physicians
Professor Clare Gerada, Past Chair of the Royal College of General Practitioners and Chair of NHS Clinical Transformation Board
Professor David Haslam, General Practitioner and Chair of the National Obesity Forum
Dr J S Bamrah, Consultant Psychiatrist and Medical Director of Manchester Mental Health and Social Care Trust
Dr Malcolm Kendrick, General Practitioner and Member of the British Medical Association’s General Practitioners sub- Committee
Dr Aseem Malhotra, London Cardiologist.
Dr Simon Poole, General Practitioner
David Newman, Assistant Professor of Emergency Medicine and Director of Clinical Research, Mount Sinai School of Medicine, New York
Professor Simon Capewell, Professor of Clinical Epidemiology, University of Liverpool
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