Monday, 30 June 2014

UK doctors stand up for truth and integrity

Dr Malcolm Kendrick wrote an interesting blog post about UK doctors challenging NICE on its guidelines on drugs and the undisclosed financial interests of those making the decisions.

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Concerns about the latest NICE draft guidance on statins
We are concerned about your draft guidance on CV risk for discussion and debate.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 individualstrue 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The draft guidance recommends offering statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.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 bias

Important 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

Playing the ball and not the man

I've written before about my frustration when discussing research evidence with people, some who treat this as interesting opinion rather than demonstrable fact.

One recent conversation was about vegetable oils and the potential carcinogenic effects of oil made from foodstuffs that are difficult to turn into oil (and require a lengthy industrial process to do so.)  The response from the sceptic, when presented with information from various cardiologists such as Dr Steven Gundry was to the effect that these people are only interested in selling their books.  I find it curious that the work of Einstein and Stephen Hawking are not dismissed for the same reason, though they both wrote books.

I overheard a heated discussion amongst a group of young men about diet and fitness.  There was some dispute about carb loading and exercise performance.  I suggested that some elite athletes follow a low carb/high fat diet.

One of the group started challenging me and the conversation quickly shifted to a debate about cholesterol and statins.  I pointed out how the NICE guidelines incentivise doctors to prescribe these drugs to groups of people that have not been shown to benefit in research studies.  I also commented on how the link between high cholesterol and heart disease had not been proven.  The young man disclosed that he is a medical student and demanded details of published research papers to back up my claims.  I quoted the work of Dr Malcolm Kendrick, Uffe Ravnskov, Duane Graveline and others.  The young man dismissed their work commenting that they probably didn't get on with their team or had other personality differences and conflicts at work.  At no point did the medical student present solid evidence to refute my statements.  He merely made derogatory remarks about the doctors I'd quoted.

The person next to me leaned over and quietly introduced himself as a cardiac lipidologist working in the medical school of a University of London college.  He told the medical student that I was absolutely right and that GPs lose money if they DON'T prescribe enough statins.  He confirmed that medical publishing subscribes to dominant paradigms and blocks publication of research that contradicts them, because the field is manipulated by big pharma.  The medical student looked confused and deflated.  The lipidologist encouraged him to keep an open mind in his work and not believe everything he is told.

I couldn't have asked for a better coincidence.  It wasn't about winning an argument, but finding a way to get through to someone who would not listen to the scientific evidence, but preferred to trash the people involved.

I was reminded of this when listening to Jimmy Moore interviewing Dr James E Carlson.  Carlson has faced his own challenges from medical students and Google AdSense, who claimed he posed a risk to readers.  He has now produced an online lecture series.  Here's number 7 of the series.  Number 8 is worth watching here:

Back to the title:  in football players are encouraged to play the ball and not the man, or risk a card for a foul.  The knee jerk response to a challenging concept seems to be to attack the author rather than present contradictory evidence.  Maybe I should carry a whistle and a red card for future conversations.

Saturday, 28 June 2014

Science and Seth Roberts

I wrote about the death of Seth Roberts in April.  He was an interesting character, who challenged shoddy statistical analysis and scientific generalisations.  His selection of interesting articles posted regularly on the blog prompted much discussion and further investigation by those interested in improving their own health.

I sometimes felt uncomfortable about his self experiments when he took interesting results from a brief trial and generalised from them.  He'd been experimenting with eating honey or sweet things before bedtime to aid sleep.  This led to some curious conclusions from Seth and his readers about the way sugar had been 'erroneously demonised'.  I wondered about his dental health as well as the impact on those with diabetes who followed his advice.

Paul Jaminet has written a nice appreciation of Seth Roberts, which looks at the strengths and weaknesses of his approach to science.  It's well worth reading.

The post starts with an announcement:  'The cause of death was occlusive coronary artery disease and cardiomegaly.'  This is based on a blog post by Seth's mother, which gives the general cause and states that more detail are expected later in the year.

Paul Jaminet makes a curious statement about Seth's approach to diet (highlighted in bold):

'But Seth was wedded to experimentation as a scientific methodology. This worked well as long as he was using sleep quality as a biomarker, since sleep quality is close to 100% correlated with health. He entered riskier ground, I think, when he selected reaction time as a biomarker to optimize. I doubt this has a simple relationship to health; I suspect one can improve reaction time while damaging health. And when optimizing this biomarker led him to consume large amounts of butter on top of large amounts of flaxseed oil, I think he should have recalled the arguments of our book, and been more persuaded by them than he was.'

I've read a lot of Seth's posts and his own diet book.  I'd understood that Seth started with sugar water and then light, flavourless olive oil as a weight loss aid.  He'd switched to butter and added flaxseed oil to improve balance and gum health.  I'm not sure how Paul defines 'large amounts' as I did not gain this impression from my reading.  My biggest concern is that Paul Jaminet is focussing on the fat intake and ignoring the rest of Seth's diet.  It is not clear to me that Seth stuck rigorously to a low carb or paleo diet.  

I'd be very concerned if people concluded that there was a cause-effect relationship between his fat intake and the blocked arteries and enlarged heart, without considering other dietary components and lifestyle aspects.  We don't have conclusive proof about what caused the heart disease.  Correlations are not causes.  Just because people carry umbrellas when it rains does not mean that umbrellas cause rain.