Citizen researchers: fighting for truth about treatments

By Jerome Burne

Rufus Greenbaum, a retired electronics engineer, has what many might consider, a highly quixotic hobby. Every few months for the last10 years he has been attending the semi-public meeting of the two big UK government organisations whose job it is to advise official bodies on such public health issues such as how much fat or carbohydrates we should be eating or what are the best treatments for conditions as varied as cancer, rheumatoid arthritis and macular degeneration. 

He had made himself an expert on two nutritional supplements – omega 3 oil and vitamin D – since he considered that “adequate levels of both could help most people live 10 years longer in better health”.  Then once he had signed up as a stakeholder, he followed the standard procedure for getting advice changed when there is good, new evidence. The two organisations were SACN (Scientific Advisory Committee on Nutrition) and NICE (National Institute for Health and Care Excellence). Since the UK government spends taxpayer money on the National Health Service, their findings are used to determine the sort of lifestyle treatment that clinicians can recommend across the UK. 

So far, however, he has had no success at all. In 2008 when he started the recommended daily amount of vitamin D was 10mcgs or 400 IUs. It’s still is. But he doesn’t believe it has been a waste of time. He has become convinced by his experience that both of these organisations have such a biased and limited understanding of non-drug treatments and what they can contribute to our health, that they are “not fit for purpose” and he is planning to publicise how they work and to campaign for urgent reform. 

The rise of the Citizen Scientist 

Greenbaum is one of a growing number of what might be called self-appointed Citizen researchers, clinicians or academics. People who use their skills to investigate official advice about nutrition or widely prescribed drugs, usually for little or no commercial gain. 

They are a vital part of the emerging grassroots movement to encourage people to take more responsibility for their health, rather than relying on the official advice which is often aligned with the vested interests of the big food and big pharma. 

It’s no longer such a surprise to discover the official advice you have been following for years to deal with disorders such as diabetes – eat more carbs – or to fend off the likes of heart disease – take statins – is strongly disputed. Furious tweets from people who have just discovered this are common. Reform is badly needed.

So, while it’s theoretically possible that Greenbaum’s campaign hasn’t prompted a change simply because his evidence isn’t up to SACN’s stringent standards, it’s far more likely it’s just habit. After all, this is a body that is still recommending the low-fat diet; another Citizen scientist Dr Zoe Harcombe recently demonstrated just how unconvincing this is – see below. 

Vitamin D: how little is not enough?

Meanwhile, Greenbaum evidence suggests that properly investigating optimum levels of vitamins and minerals could be very beneficial.  You count as being deficient in Vitamin D n the UK when your blood level is below 25 nmol/L.  A growing number of American academics and clinicians, however, regard anything below100nmol/L as deficient, resulting in reduced muscle strength and loss of calcium from bones. Among the benefits of raising it over 100 are improvements in the ability of the elderly to walk and stand up and a reduction of periodontal disease.

He told both SACN and NICE about sites run by two other Citizen activists that carry extensive evidence for the benefit of much higher levels. One is Henry Lahore, a retired engineer who had worked for Boeing and has collected a vast amount of vitamin D research data and made it available. It lists over 70 disorders that can be helped by increasing vitamin D levels – each displayed with references to the studies. 

The other initiative, started by Citizen activist Carole Baggerly, has now moved on from simply posting evidence to conducting research to assess the effects of supplementing with higher levels. Patients can get their blood levels tested and then monitor various health markers, giving much more detailed data on what it is doing and what the benefits are. 

This is the work of solid professionals. The 47 members of Baggerly’s advisory board, come from various universities including Harvard, McGill, Emory, Oregon State University and UCL Davis, LA and San Francisco, along with Birmingham and the National Orthopaedic Hospital, in the UK.

Nutritional training needed to treat lifestyle disorders

Greeenbaum’s explanation for the Committee’s willful blindness is that it is partly the result of the doctors’ cursory education in nutrition, which means they have virtually no understanding of vitamins.  As a result, they can confidently dismiss them as ‘evidence-free’ or generators of ‘expensive urine’. One committee member told him that we can get all the Vitamin D we need from the sun; another breezily declared: ‘I know nothing about nutrition.’ The other factors are the powerful commercial interests in drugs and certain types of diet.

This mindset is increasingly at odds with the growing awareness of the large part diet and lifestyle plays in our health. ‘It’s clear to me,’ Greenbaum says, ‘that the system we have that is supposed to provide the most unbiased and up-to-date health information for government and patients, is not fit for purpose.’

It’s an analysis that is borne out by the work of Citizen academic and Doctor of Nutrition, Zoe Harcombe. She has become a one-woman food-focused ‘Which?’ magazine for stress-testing official reports and studies. 

She too has been forensically critical of the work of SACN. Recently the Committee report on saturated fats was published; it concluded that the daily intake should be no more than 10% of calories – precisely the same as it had recommended in the 1980s and 1990s. 

No actual evidence that fat harmful

Dr Harcombe is an expert in saturated fat; her PhD had looked for the evidence to support the warnings about a link between saturated fat and heart disease back in the 1970s but she found none. Her follow up analysis of research over the next 40 years found none either. Yet SACN has continued to warn against it. 

The conclusion of the most recent report was not evidence-based in the accepted sense of the phrase. As Harcombe points out, the report had not actually found any evidence supporting a reduction in fat, nor for any benefit from replacing saturated fat with polyunsaturated fat for the “vast majority of conditions” including death from heart disease. 

So, what was the report’s conclusion? We were wrong? Fat is fine? Absolutely not. Instead, the committee stayed loyal to their old, evidence-free advice that we replace saturated fat with polyunsaturated fat. Submissions to the committee pointing out the lack of evidence for its conclusions in a draft report had largely been ignored.

Dr Harcombe has been doing this sort of detailed examination of reports and journal articles on most of the controversial mainstream health topics for ten years – notching up some 500 posts on her site on the likes of – cholesterol, statins, red meat, saturated fats and veganism. 

Statin claim not backed by the evidence

Recently she was one of the citizen researchers to unpick the claim that a meta-analysis supposedly showing that people over 75 could add years to their life by taking statins.  She pointed out that a table buried in the body of the text recorded that, in fact, no benefit for this age group had been found. The author of the paper didn’t deny it but tried a defence used by US secretary of Defence to George W Bush Donald Rumsfeld when faced with embarrassing evidence – one that undermines the entire RCT edifice; Absence of evidence is not evidence of absence. 

Another far more wide-ranging account of low efficacy, high rate of side effects and grossly misleading promotion of statins by Citizen clinician and cardiologist Dr Aseem Malhotra has just been published

After detailing multiple failings that the great majority of doctors either don’t know or are ignorant of, Malhotra calls for a Parliamentary enquiry to investigate. The fact it is so obviously necessary is a serious indictment of the bodies that are supposed to provide an informed assessment of the evidence. 

Greenbaum’s decision to stick with his submissions revealed just how dedicated SACN had to be to keep claiming an absence of evidence for vitamin D. In 2013 SACN finally agreed to run a trial on the benefits of supplementing, based on the sort of evidence Greenbaum had been doggedly presenting.  

How vitamin trials are fudged

But it quickly emerged that the trial had been sabotaged from the start. ‘They immediately narrowed its scope right down, so it was designed to only look at the effect of supplementing people who had a blood level below 25, ’he says. ‘You don’t need a study to discover they would benefit. It could tell you nothing, however, about the benefits of supplementing at a far higher level.’ It was at this point that Greenbaum stopped attending SACN meetings and turned his attention to NICE.

But he found the same culture was embedded there too. The response to his submissions – this time for omega3 oil as well – were equally dismissive. Either the data was not new, or it was ‘not within the scope of the guidelines’ or it was simply ignored. 

This was the sort of data being rejected. It involved giving omega 3 oils to 3000 women with early-stage breast cancer and tracking them for an average of 7 years. This was associated with a 25% reduction in breast cancer. A drug with that sort of result would be fast-tracked to development. 

Equally impressive and also ignored, was one which found that patients getting very high – by UK standards – vitamin D supplementation that raised blood levels to at least 150 nmol/L. Those getting the highest amount had ‘approximately half the death rate from cancer as those getting the lowest.’ 

‘The damage to public health,’ says Greenbaum ‘by the failure to make any proper attempt to assess the data out there and run some trials, has been huge.’

Privatising research isn’t working

So, what to do about the combination of doctors not educated in nutrition and being heavily influenced by commercial interests? Reducing our reliance on drug companies to come up with and run the tests on new treatments sounds a good idea but isn’t it wildly impractical? In fact, just such an idea is already being explored. 

Recently the ultra-respectable New England Journal of Medicine proposed setting up not-for-profit companies as a solution to the problem of getting drug companies to develop new antibiotics to combat growing resistance. The system is not working, companies are not delivering, simply because antibiotics don’t make enough money. And that is because people often get better in a week or so and stop taking them. No serious money in that. So, the proposal is that the research and drug development could be done by a not-for-profit organisation. 

‘It would encourage discovery and development of truly needed anti-biotics that improve patient outcomes,’ write the authors ‘rather than continued development of me-too drugs…[because such organisations] don’t face pressure to generate continuous revenue growth to drive up shareholder value.’ The NHS does have a research arm, but it seems to generate few reports on areas such as a combination of lifestyle interventions.

Concentrate on individuals not averages 

Non-commercial units could also be a way to avoid costly observational trials aimed at showing the effects of diet. A typical conclusion could be that X thousand people who ate less red meat (among lots of other factors) and were followed for 5 years had a 30% lower incidence of cancer. This is not useful, firstly because in terms of the number of people affected amounts to about 1/1000 but what we actually want to know are the changes in all sorts of inputs – meat or fat or doughnuts or exercise – that the diet can produce in a single body after a few hours. 

Known as an N-of-1 trial or N= 1 and described in Nature a few years ago, it records a wide range of detailed individual responses; once you’ve done a few hundred people you start getting really useful data that can prove or disprove theories or point in new directions. 

Currently, citizen researchers are often attacked for criticising official medical advice and accused of killing people by discouraging patients from taking much-needed drugs. Given the many flaws and frauds around official advice, they should be feted for keeping healthy scientific debate alive. 

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “The Hybrid Diet” was written with nutritionist Patrick Holford, published 2018. Award: 2015: Finalist for 'Blogger of the Year' Medical Journalists' Association.


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