Cholesterol, Statins, the CTSU and the Mail on Sunday
Before I did what I do now I worked as the HR Director at management team level for a number of blue chip organisations. I was privileged to receive some world class training in a number of different areas; one of which was bullying. I will never forget the ACAS definition of bullying that was instilled in us at the time: Bullying is an act designed to undermine, humiliate and intimidate. Those three words were so well thought through, so appropriate and so precise. Make no mistake – today’s hatchet job in the Mail on Sunday is an attempt to undermine, humiliate and intimidate me, Dr Aseem Malhotra and Dr Malcolm Kendrick.
On Thursday evening (28th Feb 2019) I received an email from Barney Calman. I have lunched with Barney. He has received my Monday note for years for free. I have helped him with numerous articles and quotations for free (I think I received a tiny contribution following one nightmare article). If you read just the words in black below, you will be able to see the email that I received. I was given until noon the next day to respond. Aseem and Malcolm received almost identical emails and were given similar deadlines. Aseem didn’t bother replying – his view was that they’re going to print what they wanted to anyway, so why bother. He was right. Malcolm and I did reply. The words in red below are my reply.
The Mail on Sunday plans to publish an article this weekend on growing concerns about claims you and a number of other individuals have publicly made about statins, the role of cholesterol in heart disease, and the allegations that researchers into the drugs are financially conflicted due to payments made to the organisations they work for, and so the evidence they provide about the effectiveness of these medications, and their side effects, are in some way untrustworthy.
Over the past 30 years, more than 200,000 patients have been put through the most rigorous forms of clinical trials to produce definitive proof the tablets lower heart attack risk by up to 50 per cent, and a stroke by 30 per cent, and reduce the risk of death – from any cause.
ZH comment – these are relative risk numbers, not absolute risk. Following the 2012 CTSU publication about statins (Ref 1), I wrote to the research team asking for access to the raw data so that I could examine absolute risk (among other things). I was refused access to the data. The exact reply was: “The CTT Collaboration holds data on a very strict basis and is not able to provide participant level data to third parties” (Ref 2).
Other doctors, academics and researchers have asked for the CTSU/CTT Collaboration data to be shared – including that on serious adverse effects – and it has been consistently refused as “commercially sensitive/confidential.”
The Editor in Chief of the BMJ, Dr Fiona Godlee, has asked for an independent review into the withholding of statin trial data arguing that “no single person or group should have exclusive access to data” (Ref 3).
In the absence of access to the CTSU data, we must rely on the independent assessment of all evidence for the efficacy of statins presented in the form of numbers needed to treat (an absolute measure). This reports that, for primary prevention (the majority), for those taking statins for 5 years, no lives will be saved and between 2 and 15 times as many people will be harmed (muscle damage, type 2 diabetes) as helped (avoiding an event) (Ref 4).
Lives are, of course, never saved. We are all going to die. The measure of interest is – by how much might a life be extended by a particular intervention or drug? This was independently assessed in a non industry-funded paper (Kristensen et al 2015). This paper reported that if someone took a statin for five years (and endured any side effects for that time): “The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively” (Ref 5).
(See ps at end on this)
In January, the editors-in-chief of all 30 major heart health medical journals – each a leading cardiologist – signed a joint open letter, warning: ‘Lives are at stake [due to the] wanton spread of medical misinformation. It is high time that this stopped.’
A 2016 analysis from the London School of Hygiene and Tropical Medicine, which tracks outbreaks and public health concerns, found fake news about statins may have prompted 200,000 patients in Britain alone to quit the drug over a single six-month period following an article you wrote for the BMJ which claimed, incorrectly, that 20 per cent of statins patients quit the drug because of side effects.
They estimate that up to 2,000 heart attack and strokes could be a result of this. We would like to offer you the opportunity to respond to this and the following:
ZH comment – I have not written any articles in the BMJ (or any other journal) about statins.
*You recently blogged: ‘High cholesterol is not even associated with high heart disease, let alone a cause of it.’ This contradicts the aforementioned clinical trials and encourages patients to ignore medical advice to take potentially life-saving (ZH comment – no lives will be saved – see above) medication.
ZH comment – this is a fact. High cholesterol is associated with low mortality – from cardiovascular disease (CVD) and deaths from all causes – for all 192 counties in the world.
In 2010, I examined the World Health Organisation data for 192 countries for mean cholesterol levels and deaths from CVD and all-cause mortality for men and women. The relationships turned out to be inverse, for men and women, CVD and all deaths, as shown by these graphs (Ref 6).
*In a 2014 newsletter you call cardiologists, researchers and bodies involved in statin research ‘statin pushers’ – echoing the term drug pusher, or someone encourages others to take harmful drugs and who makes money supplying those drugs. You appear to justify this by listing those who have received remuneration or funding in some form or another from pharmaceutical companies.
ZH – comment. It would be naïve not to think that sums such as £268 MILLION (payments from pharmaceutical companies to CTSU by 2014) and $149 BILLION (what one statin alone has earned one company) (see below) encourage recipients to aggressively encourage people to take those drugs. Just a couple of weeks ago, the Mail on Sunday front page story argued that climate change chief, John Gummer, should quit over his green business conflicts, which amounted to £600,000. The same Mail on Sunday is now trying to bully little me into silence for blogging about vastly greater sums of conflicts of interest! (Ref 7)
*It has been alleged that the potential consequences of this, and other claims you have made about statins and cholesterol, far outweigh that of the infamous MMR vaccine scandal with one researcher saying: ‘In terms of death and disability that could have been prevented, this could be far worse.’
ZH comment – any attempt to connect any topic to the MMR vaccine scandal is a deliberate and nasty attempt to smear. Rory Collins heads up the CTSU/CTT Collaboration – the organisation that refuses access to data that could improve patient care. Rory Collins made this association in a deliberate and nasty attempt to smear anyone who even wants to discuss cholesterol and/or statins (Ref 7). He is trying to bully doctors and researchers into silence and the Mail on Sunday is collaborating with this bullying.
Collins tried (and failed) to have two papers withdrawn, which referenced another paper that quantified statin side effects (Ref 9). During the investigation into Collins’ demands for retractions it emerged that, as of 2014, the CTSU had received £268 MILLION from the pharmaceutical industry (perhaps the Mail on Sunday could find out how high this figure is now?) (Ref 10) That’s 268 MILLION reasons to silence debate. The Mail on Sunday should be investigating this Goliath conflict of interest, not a couple of ‘Davids’ who are brave enough to ask questions.
Collins claims that not more than 1 in 50 people will suffer side effects from statins (Ref 9). The same Collins has a patent that identifies patients at increased risk of myopathy (muscular pain). “The test, branded as Statin–Smart, is sold online for $99 (£76) on a website that claims 29% of statin users will suffer muscle pain, weakness or cramps. The marketing material also claims that 58% of patients on statins stop taking them within a year, mostly because of muscle pain” (Ref 11). That’s misinformation.
The patient leaflet must be honest, by law, about side effects. The patient leaflet for Lipitor lists common side effects, which may affect up to 1 in 10 people, as: nasal inflammation; nose bleeds; increase in blood sugar levels (google “statins diabetes lawsuit”); gastric problems; joint pain; muscle pain; back pain; abnormal liver function (Ref 12). This is the harm that Collins wants silenced. Lipitor, by the way, has earned Pfizer, one of the CTSU funders, $149 BILLION by 2016 (Ref 13).
*In our article, one leading cardiologist states that comments you make in interviews and in writing about cholesterol and statins sound convincing but that in reality ‘they contain a grain of truth, mixed with speculation and opinion, which makes is very difficult for the public to know who to trust.’
ZH comment – whom to trust – the public should trust those who are not earning £MILLIONS and $BILLIONS, while refusing to share invaluable data. Data that could improve patient care.
*You often quote observational studies as proof of your claims about statins and cholesterol in articles and blog posts which contradict findings of authoritative clinical trials, which you do not mention. This is misleading.
ZH – give me an example?
*Your stance on statins and the link between cholesterol and heart disease amounts to misinformation.
ZH comment – This is a false accusation and I will take further action if you make false accusations. I have examined the entire data provided by the World Health Organisation and found that higher cholesterol is associated with lower deaths, from CVD and all-causes, in men and women, for all 192 countries in the world.
My PhD was an examination of the diet (cholesterol) heart hypothesis. Cholesterol is mentioned 612 times. I have studied this topic at the highest level for several years and I am entitled, if not obliged, to share what I have found.
I’ll tell you what misinformation is – on 1st February 2019, a paper was published in The Lancet by the CTSU/CTT Collaboration (Ref 14). A press conference was held to launch the paper. The lead CTSU author, Colin Baigent, was quoted as saying: “Only a third of the 5.5 million over 75s in the UK take statins and up to 8000 deaths per year could be prevented if all took them.” This is false. It relies upon evidence in the over 75s for both deaths and primary prevention and neither was found. Figure 5 of that paper confirmed that the Rate Ratio for deaths in the over 75s was not statistically significant. Figure 4 of that paper confirmed that the Rate Ratio for primary prevention was not statistically significant. I have written to the authors (through The Lancet) asking why they have claimed something that they did not find. I have received no reply. The public should also have been warned that the patient leaflet for statins cautions against people over 70 years old taking them (Ref 12).
Another example of misinformation (in addition to that above on side effects) is the continual use of relative risk numbers to scare people into taking statins. You reiterated this misinformation above “lower heart attack risk by up to 50 per cent, and a stroke by 30 per cent.” The absolute difference, even for secondary prevention, for those who manage to take statins for 5 years, is 1 in 39 for a heart attack and 1 in 125 for a stroke. Meanwhile 1 in 50 were harmed by developing type 2 diabetes and 1 in 10 were harmed by muscle damage (Ref 15).
Withheld information is also an issue here. The information being withheld by those running the trials for the pharmaceutical industry is the scandal. Patients are being harmed by not knowing true benefits and true side effects.
The Mail (on Sunday) has always been a bastion for debate – you’re asking the wrong questions of the wrong people on this one.
*If you wish for any comments to be included in our article please send them to us by midday this Friday.
ZH comment – Not least as someone who has freely assisted the Mail/Mail on Sunday with many articles and quotations, I expect to be treated fairly, with balance and not quoted out of context.
END of email exchange
We should be flattered – the might and wealth of the Oxford statin Clinical Trial Service Unit and the might and wealth of the Mail on Sunday deem it necessary to try to silence three individuals. But then, when one statin alone has earned one company $149 BILLION, the motivation to end debate is clear.
I’ll leave you with some of the comments below the article. There are way more than three people concerned about statin side effects. Perhaps everyone should buy Collins’ patented gadget to assess their own risk before taking statins:
“Let all these professionals, all ages, take Statins themselves for a few months and then comeback and lie through their teeth and all they all still say the same thing!!! I bet they couldn’t!“ (@Colleen)
“I’ve tried all of the top six brands of statins. All slightly different but all with terrible side effects. After three years of what can only be described as hell i’m now statin free, loving exercise and healthy eating as an alternative. I feel a million times better off these meds than on them. Definitely a cover up of sorts going on as far as I can see. “ (@ Pressacian)
“But statins also increase the risks of your developing type 2 diabetes, which is on the rise and is a risk in itself. I am pre diabetic and as that puts me in the increased risk of heart attacks group I was offered statins. Even though my cholesterol had been tested and was very good. I pointed out that taking statins would likely send me fully diabetic, while lowering my already normal cholesterol, but the GP said that the policy was to prescribe statins to anyone in the increased risk group, regardless of why they were there. It seems interesting that the rise in type 2 diabetes coincides with the increased use of statins the last decade?” (@Julie)
“Drugs are a billion dollar business. Drug companies are legally allowed to give bribes to doctors. Always do your own research, find out how the drugs work and what the side-effects are. “ (@Lin)
“This whole article reads like paid advertising, from the title to the critics of statins referred to throughout as “deniers” instead of what they are, critics or opponents.“ (@Suzette)
p.s. both Malcolm and I mentioned this 2015 study. The response in the article from Colin Baigent at the CTSU on this point was highly amusing. He said: “The 2015 study Kendrick mentions only looked at life extension over the trial period of a few years. Statins are lifelong drugs, and the extension of life over a lifetime will be very much greater.” So multiply 3-4 days for every 5 years that you manage to take statins and that’s your potential gain. Then weigh that up vs. the side effect pain for multiples of 5 years.
Ref 1: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60367-5/fulltext
Ref 2: http://www.zoeharcombe.com/2016/09/the-lancet-statin-study/
Ref 3: https://www.bmj.com/content/354/bmj.i4992.full.print
Ref 4: http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease-2/
Ref 5: https://bmjopen.bmj.com/content/5/9/e007118.abstract
Ref 6: http://www.zoeharcombe.com/2010/11/cholesterol-heart-disease-there-is-a-relationship-but-its-not-what-you-think/
Ref 7: https://www.dailymail.co.uk/news/article-6661513/Climate-Change-chief-John-Gummer-faces-calls-quit-payments-green-businesses.html
Ref 8: https://www.theguardian.com/society/2014/jun/13/professor-statins-row-government-intervene
Ref 9: https://www.bmj.com/content/independent-statins-review-panel-report-0
Ref 10: https://www.bmj.com/content/independent-statins-review-panel-report-0 (See SP21) and
Ref 11: https://www.thetimes.co.uk/article/statins-expert-in-row-over-level-of-risk-to-patients-gmd30wqvj
Ref 12: https://www.medicines.org.uk/emc/files/pil.1059.pdf
Ref 13: https://www.fool.com/investing/2017/03/13/the-19-best-selling-prescription-drugs-of-all-time.aspx
Ref 14: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31942-1/fulltext
Ref 15: http://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heart-disease/