Dr Aseem Malhotra: The impact of dietary changes in the context of modern medicine at The Old Mutual Health Convention

There is an epidemic of misinformation among doctors and patients.

There are seven sins that contribute to this lack of knowledge:

  • Biased funding of research (research funded because it is likely to be profitable, not because it is likely to be beneficial for patients)
  • Biased reporting in medical journals
  • Biased patient pamphlets
  • Biased reporting in the media
  • Commercial conflicts of interest
  • Defensive medicine

We have medical curricula that fail to teach doctors how to comprehend and communicate health statistics. There is statistical and health illiteracy amongst doctors and patients. There are many ways of presenting a benefit while hiding risk. Using relative risks as opposed to absolute risks is a common way of misleading the public without actually lying, which overestimates the benefits of medical intervention.

There are also financial conflicts of interest and a culture of more treatment is better:

  • Financial influence of individual doctors to earn more based upon the number of investigations and procedures can sometimes put profits before patients
  • One US cardiologist admitted to ordering $19 million dollars worth of unnecessary investigations and procedures. (This could be just the tip of the iceberg. Angioplasty is just one example.)
  • Fee for service model in US health system contributes to over use.
  • In the UK “payment by results” is often “payment by activity”
  • Unnecessary coronary stenting is estimated to cost US health care $2.4 billion dollars a year (By American College of Cardiologists Criteria -11.6% of stenting for stable coronary disease is inappropriate and 38% of “uncertain appropriateness”)
  • Large and accepted body of evidence that stenting for stable coronary disease does not improve prognosis – multiple RCTs
  • 88% of patients believed they were having it done for that very purpose
  • 43% of cardiologists said they would still go ahead and do the procedure even if they felt it would NOT benefit the patient
  • Other drivers : include the technological imperative ( using new technology despite no gold standard evidence of benefit), asymmetry of information that exist between doctor and patient and demand?

In a WHO Bulletin in 2009, Dr Gerd Gigerenzer, Director of Harding Center for Risk literacy, Berlin, says: “ It is an ethical imperative that every doctor and patient understand the difference between absolute and relative risks to protect patients against unnecessary anxiety and manipulation”.

One way of reducing potential harms is with more informed consent:

  • Making it mandatory on the consent form that stents do not improve prognosis could help to reduce patient anxiety, reassure of the benefits of medical therapy and encourage a more informed discussion about equally if not more important lifestyle changes
  • Reduce potential harm of a procedure that still carries a 1% risk of heart attack, stroke or death.
  • When patients were told the lack of prognostic benefit for PCI, only 45.7% elected to go ahead with the procedure versus 69.4% who were not explicitly given this information

An overemphasis on medical treatment may be detracting from addressing chronic non-communicable diseases of lifestyle. One sign is rising obesity rates.

  • 60% of the adult UK population are either overweight or obese
  • 1 in 3 children in the same category –trends increasing
  • Foresight report: If we do nothing 90% Of UK population overweight or obese by 2050
  • Currently costing the NHS £6 billion/year > £50 billion
  • Total cost of diabetes close to £20 billion; double by 2035
  • NCDs (diet as a risk factor) have now overtaken under nutrition as the commonest cause of death worldwide

Obesity is probably just the tip of the iceberg. One major problem is the obesogenic environment. No one can argue that processed foods are everywhere, and unavoidable. The very institutions that are supposed to be promoting health, promote junk, unhealthy food and drink. Even Guys Hospital has a McDonalds sign.

The hospital food environment is toxic:

  • Thousands of visitors and patients create branding opportunity for the junk food industry ( thousands of visitors per week)
  • Legitimises the acceptability of junk food ( fast food on site, vending machines)
  • Hospital trolleys – loaded with junk
  • Education ineffective when food environment is working against you- 50% of 1.4 million NHS employees overweight or obese
  • Perpetuates the revolving door of health care

Public health guidelines don’t help, and can even make things worse. There is an overemphasis of physical activity. Obesity should not be spoken about in the same breath as physical activity. There is no proven link.

Regulation is needed to reduce the obesity epidemic. Smoking bans have proved their worth. Industrial trans fat policies are shown to work.

We need to look at changing official dietary guidelines. We have been giving the wrong advice:

  • 1970 American Scientist Ancel Keys, 7 countries study- saturated fat – increased cholesterol- main dietary cause of heart disease.
  • Change in dietary advice in 1977/1984 – eat less fat and more carbs! ( <30% fat <10% sat fat)
  • Food industry exploitation of “low fat” mantra has resulted in diets high in refined carbohydrates (sugar)
  • Prevalence of obesity and type 2 diabetes in western population has rocketed since.
  • Selective data. Keys’ observational correlations did not appear so strong when other countries were included.
  • Also sampled Greek population during Lent when people fasted- avoiding meat-eating, and less sat fat
  • Keys’ received research funding from sugar industry

We also need to bust the myth that saturated fat is the issue in heart disease. It isn’t. We need to take the focus away from a single nutrient such as fat and saturated fatty acids (SFA).

It is the:

  • Source of the SFA that matters
  • What replaces SFA in the diet is what matters
  • SFAs are often replaced with refined carbohydrates
    • Many low-fat products have high sugar content
    • Place more emphasis on foods and on diet patterns
  • We need to place emphasis on healthy diets within healthy lifestyles

We also need to look at the evidence on statins and whether people at low risk of cardiovascular disease should be taking them. Recent NICE guidance in the UK recommends a lowering of threshold to prescribe statins to those with a CVD risk to 10%. But is this a good idea? It could be over-medicalising groups that don’t need it.

A letter written to the Secretary of State for Health signed from prominent signatories that included the president of the Royal College of Physicians, Sir Richard Thompson, Past Chair of the Royal College of General Practitioners Clare Gerada and Chair of the National Obesity Forum David Haslam stated

There is the problem of hidden data:

  • Without access to the raw data, it is difficult to understand how statin related adverse events, and placebo related adverse events can mirror each other so precisely, whilst the absolute rates can vary thirtyfold.
  • The data driving NICE guidance on statins comes almost entirely from pharmaceutical company funded studies. Furthermore, these data are not available for review by independent researchers, only those who work for the Oxford Cholesterol Treatment Trialists Collaboration (CTT).
  • The CTT has commercial agreements with pharmaceutical companies, which apparently means that they cannot release data to any other researchers who request to see it. This, in turn, means that the latest reviews of the data by NICE and also by the Cochrane group are totally reliant on the CTT 2012 meta-analysis analysis of this concealed data.

There is also the problem of industry bias. Extensive evidence reveals that industry sponsored trials systematically produce more favourable outcomes than non-industry sponsored ones. And notably, only one major non-industry funded study on statins has been done.

There are serious conflicts of interest. For example, eight members of NICE’s panel of 12 experts for its latest guidance have direct financial ties to the pharmaceutical companies that manufacture statins.

Also:

  • We feel that parties with industry conflicts should not be participants in generating recommendations regarding drug use that will influence medical care across the population
  • We fear that the CTSU could be perceived as having a major conflict of interest in the area of cardiovascular disease prevention/lipid modification, which has an impact on the Unit’s perceived objectivity
  • CTT is a part of the Clinical Trials Service Unit (CTSU) in Oxford, which has carried out many very large studies on statins, and other lipid modification agents with pharmaceutical company support, and has received hundreds of millions in funding over the years.
  • Calls have been made for release of raw data and review by independent researchers such as the Cochrane Heart and Stroke groups.

Some conclusions:

  • Saturated fat is not the major issue
  • Source and type of saturated fat is important
  • Need to focus on foods/diets with proven benefit to reduce cardiovascular events and mortality – Mediterranean diet still has best evidence base.
  • Focussing on cholesterol lowering alone has been counterproductive. As  Professor Rita Redberg said: “Who cares about cholesterol lowering if it doesn’t benefit the patient.”
  • We should embrace pharmacotherapy in the right groups plus lifestyle. One is not a substitute for the other.
  • We need all the data made available to make more informed decisions, and more robust studies to determine true incidence of side effects that interfere with patients’ quality of life.

In comparison with modern treatments for heart disease such as aspirin, statins and stents, a Mediterranean Diet is the most effective coronary intervention tool we have proven from randomized controlled trials, but we have held back such empowering and important information from our patients and the public. When everyone knows this, then do we truly have transparency which leads to accountability which leads to the best quality health care.

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