It’s not about statins – it’s about censorship

Two very serious things happened last week – one in Australia and the other in the UK, although both are about information on line, so they have global impact…

Catalyst – Australia

Last October, two programmes aired on ABC television under the “Catalyst” banner (Catalyst is like Horizon – a science/investigation kind of programme). The first programme was called “Heart of the Matter Part 1 – Dietary Villains” and it aired on 24th October 2013. A transcript and copy has been preserved by someone on line. You can currently see it here, but I’m not sure for how long. The transcript of the programme is also available on this link. In essence – this programme challenged the widely held view that saturated fat causes heart disease.

The second programme aired on 31st October 2013 and, again, it can currently be seen here (video and transcript). This programme was called “Heart of the Matter Part 2 – Cholesterol drug war.”

Those who stand to gain from the diet-heart-cholesterol hypothesis did not want these programmes aired. There were calls for the second programme to be cancelled, after the first programme had been shown. The person making these demands, professor Emily Banks, admitted that she “didn’t have a lot of detail” about the cholesterol programme, but wanted it pulled anyway.

Both programmes aired. Catalyst is the only science show on Primetime Australian TV and it pulled in approximately 1.5 million viewers. That’s approximately half the number of people who take statins in Australia, by the way.

Barely had the closing credits run before the pro-statin brigade swung into action. A formal complaint was lodged with the body that reviews “Audience and consumer affairs” and a few months later, the findings were published in a 49 page document. In between airing and publication, Catalyst – producers and presenter (Maryanne Demasi) – were pretty much paralysed from doing further work by the demands placed upon them by the investigation.

You can read the full report. You may like to wait for a Dr Malcolm Kendrick blog – due any time now – where he summarises all the complaints made against the two programmes and those rejected and upheld. Nothing was upheld against the first programme on dietary fat and yet this has been pulled. For the second programme on cholesterol, I lost count of the judgements that recorded “no breach” of any of the codes – 16 I think. There was 1 breach upheld – and 1 alone. This is on P46 of the 49 page report.

The investigation concluded that in one part of one programme the presentation favoured an anti-statin view more than a pro-statin view. The report did not recommend that the programme be removed from the ABC web site and condemned to the scrap heap. You can see the recommended remedy on p4 of the report “We suggest it would be appropriate for additional material to be made available on the special ‘Heart of the Matter’ program website.” And that’s about it. Yet this programme has also been pulled – ABC have caved in to the pressure placed upon them by statinators. The intention of those who promote statins was no doubt to ensure that a programme like this is never aired, touched or conceived of again. They didn’t want this one to air. Tragically, they have almost certainly achieved their aim.

I tweeted the irony of the judgement – that the pro-statin bias prevails 365 days a year and yet 1 hour of a TV programme, where one small part was slightly less than balanced towards both pro and anti-statin views, is silenced – for bias! This isn’t about statins. It’s about censorship.

UK – BMJ

In the UK, in the same week, same drug, we also experienced censorship. Only this time, thanks to the robustness of BMJ editor-in-chief Fiona Godlee, we experienced only a small censorship – for now anyway.

On 15th May, Fiona Godlee published this editorial in the BMJ Godlee noted that, in October 2013, the BMJ “published an article by John Abramson and colleagues that questioned the evidence behind new proposals to extend the routine use of statins to people at low risk of cardiovascular disease. Abramson and colleagues set out to reanalyse data from the Cholesterol Treatment Trialists’ (CTT) Collaboration. Their contention was that the benefits of statins in low risk people were less than has been claimed and the risks greater.”

Godlee continued, “In their conclusion and in a summary box they said that side effects of statins occur in 18-20% of people. This figure was repeated in another article published in the same week in The BMJ by Dr Aseem Malhotra. The BMJ and the authors of both these articles have now been made aware that this figure is incorrect, and corrections have been published withdrawing these statements. The corrections explain that although the 18-20% figure was based on statements in the referenced observational study by Zhang and colleagues—which said that “the rate of reported statin-related events to statins was nearly 18%”. The BMJ articles did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of Zhang and colleagues’ data.”

Godlee had been alerted to ‘the error’ by Rory Collins, head of the Cholesterol Treatment Trialists (CTT) Collaboration, whose data were reanalysed by Abramson and colleagues. Godlee says in her editorial that Collins visited her at The BMJ in early December and then took the matter up in the UK media towards the end of March 2014.

The Guardian article references Collins as follows: “The Oxford academic said the side-effect claims were misleading and particularly damaging because they eroded public confidence. “We have really good data from over 100,000 people that show that the statins are very well tolerated. There are only one or two well-documented [problematic] side effects.” Myopathy, or muscle weakness, occurred in one in 10,000 people, he said, and there was a small increase in diabetes.”

The challenges that the Guardian should have made:

The Guardian should have ascertained how independent/conflicted their source was. These are the two pertinent questions:

1) How much, Professor Collins, have you/your department/your charity/your family – whatever outlets you have – received directly and/or indirectly from the pharmaceutical industry during your lifetime?

2) You head the CTT. Why will the CTT not release Serious Adverse Effect data (and raw data generally) from clinical trials so that researchers, doctors and patients can fully understand the side effects of statins? How can you claim that statin side effects are negligible when you won’t share the data?

The Guardian should have done their own (simple) research into statin side effects. Here are two pertinent questions:

1) If side effects are as rare as you say, why does the patient leaflet for Lipitor – the most lucrative statin, indeed the most lucrative drug ever in the history of mankind, state the following:

“Common side effects (may affect up to 1 in 10 people) include:

inflammation of the nasal passages, pain in the throat, nose bleed

allergic reactions

increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase

headache

nausea, constipation, wind, indigestion, diarrhoea

joint pain, muscle pain and back pain

blood test results that show your liver function can become abnormal

2) If diabetes is to be dismissed so lightly, why is the diabetes statins lawsuit gathering pace in the US? (Google diabetes statins lawsuit) and why is “increases in blood sugar levels” listed as one of the common side effects in the patient warning leaflet?

Funding

The web of funding around Collins, CTT, CTSU (Clinical Trial Service Unit) has proved astoundingly difficult to get to the bottom of. I had a bit of a breakthrough recently and came across a declaration of interest for Colin Baigent – CTT secretariat and close senior colleague of Collins. Check page five for current and recent grants. The following have been awarded to Colin Baigent and Rory Collins, (with other names mentioned alongside):

Merck & Schering £39 MILLION (2002-2011)
Merck £52 MILLION (2005-2013)
British Heart Foundation £9 MILLION (2005-2013) (Where does the BHF get that kind of money?) & then another grant from the BHF for £2.7 MILLION (2004-2013) & then a couple more for several hundreds of thousands of pounds.
Medical Research Council £13.8 MILLION (2008-2013) (Check the most recent appointees to the MRC – a Senior Vice President of Pfizer and Executive Vice President of Astra Zeneca).
Bayer A mere £965,000
John Wyeth Ltd £500,000
Novartis £350,000

 

That’s £116 MILLION before you get into the small change.

Censorship

ABC has caved in, despite no judgement requiring them to do so. Godlee has asked a third party to review both articles to see if the current revisions are sufficient, or to decide if the two articles should be pulled. Collins wants both articles to be retracted. As Godlee points out: Malhotra’s article is primarily about saturated fat – it merely references the Zhang article, which Collins is not happy about and the Abramson article is primarily about the fact that the CTT data failed to show that statins reduced the overall risk of death in people with a <20% 10 year risk of cardiovascular disease. This is an important fact, which is important to be openly available.

I have no doubt that Collins would like these two articles deleted from the records forever. For him it may be about the statins that have funded him/his department/wherever to the tune of over one hundred million pounds. For the rest of us it’s about censorship.

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15 comments on “It’s not about statins – it’s about censorship
  1. avatar Stephen Town says:

    Both episodes are still on YouTube and are well worth watching. Zoe’s link will take you to an audio and scripted version, but if you want to watch the programmes (and it’s good to see the faces) search under ‘Catalyst statin’. The titles are actually ‘The Heart of the matter’ Episode 1 and 2.

    If you search YouTube for Nina Teicholz, Zoe Harcombe and Aseem Malhotra, you should find an interesting radio programme called ‘The Truth About Fat’. There’s a fantastic interview with Alison Tedston from Public Health England, who tries to defend the current ‘eatwell’ plate. Initially she disputes that it contains a can of coke and then says the guidance is about heart disease not obesity! As if there’s no link between obesity and diabetes and heart disease. It’s stunning in its stupidity. With people like this running the show, it’s little wonder we’re in such a dietary advice mess.

    Zoe, well done and keep up the good work. I think the supertanker is turning!

    • avatar Zoë Harcombe says:

      Hi Stephen – many thanks for your kind words and optimism! I’m optimistic too – people can only stay ignorant for so long!
      We’ve all got copies of the Radio 4 prog thank you – and agree with you – forget our interviews – that last 5 mins was priceless!
      Best wishes – Zoe

  2. avatar Jacqui says:

    Excellent news here – hope it gathers momentum and NICE are called to task: http://www.telegraph.co.uk/health/healthnews/11201669/GPs-refusing-to-prescribe-statins.html

  3. avatar M. Cawdery says:

    This comment was sent to the BMJ Rapid Response on statin Adverse Reactions. It was REJECTED. I am not surprised; it confirms my belief that any comment relating to the neurological adverse reactions to statins (polyneuropathy, Parkinson’s, ALS, transient global amnesia (TGA) and Alzheimer’s) is rejected while flawed articles (missing critical data on therapy, cholesterol levels and the time-line) suggesting statin benefits are regularly accepted.

    Rapid Response BMJ 29/05/2014

    I would like to draw attention to the neurological effects of statins. Pfrieger and colleagues have drawn attention to the importance of cholesterol in neuron synapse activity in a series of reports (Science. 1997 Sep 12;277(5332):1684-7; Science. 2001 Nov 9;294(5545):1354-7.; Curr Opin Neurobiol. 2002 Oct;12(5):486-90) while Muldoon and colleagues have drawn attention to reduced memory effects (Am J Med.. 2000 May. 108(7):538-46; Am J Med. 2004 Dec. 117(11):823-9).

    In particular the association between low cholesterol, Alzheimer’s (AD) and statin use concerns me. Lorin’s review published in his book “Alzheimer’s Solved” (an extensive review of some 3000+ references) associates low cholesterol with AD and statin use. The AD/PD 2009 conference raised the query – Are We Experiencing an Alzheimer’s Epidemic? Incidence Has Soared Enormously in the 85+ yr-old group from 2% in the 1960s to and expected 50% in the near future!
    http://www.medscape.com/viewarticle/590106

    The particular paper that raised queries was the report by Solomon and colleagues (Dement Geriatr Cogn Disord 2009;28:75–80). This study attempted to prove that high mid-life blood cholesterol levels were associated and causal for AD. It used data from a Kaiser Permanente cohort with updated follow-up information. The authors examined the full range of cholesterol values (not just high cholesterol, 240 mg/dl, ~6.0 mmol/L), to determine whether even moderate elevations may be associated with increased dementia risk. The data provided was extensive but excluded all data on treatment and subsequent cholesterol levels.

    Patient records without treatment data? I find that very odd; ask yourself why such data was not presented or was it simply redacted to obtain acceptance for publication?

    Tables 2-4 provide the data on which the study concludes that high mid-life cholesterol is associated with AD. However, if the row titles are replaced with guideline recommended treatment (which was not available), neither the numbers nor the statistics change but a very different interpretation can be made.

    Returning to the original Table 2 cited above, the following analysis can be performed:

    Table Showing 2 x 2 analysis (CSS) for combined AD and VaD and assuming TC values above 239 mg/dl as treated with statins. Given the official guidelines and the American paranoia regarding cholesterol this is almost certain. Added after submission to BMJ but covered in appended *pdf files in email correspondence

    Cholesterol categories No dementia %age AD + VaD %age TOTAL %age

    NO TREAT (239 mg/dl) 2932 50.31 215 3.69 3147 54.00

    Totals 5477 93.98 351 6.02 5828 100
    χ2= 7.92 p= 0.0049 i.e those patients with cholesterol level >239 mg/dl (>6 mmol/L), (and that would be treated with cholesterol lowering drugs, possibly for decades) are more likely to become demented (Alzheimer plus vascular dementia)!
    V2 = 7.91 p= 0.0049
    Phi2 = p = 0.0014

    After all the vast majority of statin takers (80-90% or 99% according to some) do not suffer adverse reactions so would continue to take them for 2-3 decades.

    This raises questions regarding the absence of subsequent cholesterol levels and therapeutic treatment during that 2-3 decades. Why was this data left out? Was it because Kaiser Permanente has to negotiate with Big Pharma on drug prices? Was it because Big Pharma would not be pleased at any association of statins with AD? The current controversy suggest that they would not.

    The most interesting aspect of Solomon’s report is that many major UK NHS Trusts probably have sufficient data over the last couple of decades to repeat Solomon’s study.

    Will it be done? I suspect not – too much money and statuses at stake!

    • avatar Zoë Harcombe says:

      Hi Mike – many thanks for sharing this here. You’re probably right on the rationale for non publication. You clearly know lots about this area. Maybe the statinators are even less prepared to admit mind problems than they are body problems. The idea that statins (the taking of which has increased dramatically) could be related to dementia/Alzheimer’s (the incidence of which has increased dramatically) must surely not be made!
      Best wishes – Zoe

  4. avatar Gill P says:

    I have downloaded the articles too.

  5. avatar Peter Lawton says:

    I’m wondering about Jane’s reported drop in cholesterol level from 6 to 3.4: is that good news, or a signal to really find out a bit more?

    • avatar Zoë Harcombe says:

      Hi Peter – cholesterol is always only ever a marker – or your word – a signal. I wouldn’t worry much
      1) because the test is so inaccurate
      2) because we don’t even know what we’re measuring 1 equation, 4 unknowns, 2 can be measured (inaccurately) = a whole lot of not much
      3) because the higher reading could have been at the end of the winter and the lower reading after sunshine? Would just reflect vit D had been made
      4) because the body makes what it needs so was the 6 at a time of injury/stress/illness – is the 3.4 not?
      5) because one could have been a fasting reading and the other not?
      There are so many factors – it can be of interest but there are many things that get in the way. I would so much rather docs ditched testing for this and spend 30 secs asking people what they eat! Can tell a lot more about how healthy they are likely to be :-)
      Best wishes – Zoe

  6. avatar Jane Serafy-nafis says:

    Had a health check today. They wanted to test my cholesterol levels and I told them that even if it was high I wouldn’t take a statin. When I last had my cholesterol tested several years ago it was around 6. Today my level was 3.4. The only thing I do differently now is eat The Harcombe diet way and have lost 18lbs and kept it off. I can therefore only conclude that eating a higher fat lower carb diet has reduced my cholesterol.

  7. avatar Jonathan Bagley says:

    Hi, I watched them both from here. I thought the presenter was outstanding – a model of clarity. The programmes were excellent compared to what we now get. Sugar v fat, for example.
    https://www.youtube.com/watch?v=GdQaWWlTEnY#t=49
    It’s possible to stop the way back machine form recording web pages, but once it has them, they are there for eternity, or perhaps not. It will be useful to know.

  8. avatar Clinical Trial Data says:

    Hi Zoe,

    Thanks for your article. You might remember in the Catalyst Part 2 episode on statins that Maryanne concluded her presentation with these words…

    “Until the science of clinical trials can break free from commercial interest, then decisions about our health rest in the hands of big business.”

    You might be interested in a report that was recently presented to the U.K ‘House of Commons-Committee of Public Accounts’ regarding access to clinical trial information. It’s informative reading & a link to the report is below.

    Report – Access to Clinical Trial Information;
    http://www.publications.parliament.uk/pa/cm201314/cmselect/cmpubacc/295/295.pdf

    Thanks again for your article.

  9. avatar George Henderson says:

    This is excellent Zoe. I don’t think this clumsy censorship will help sell statins in the long run. Imagine how useful drugs could be if they weren’t overprescribed to take in as much money as possible. Is there any drug, other than vaccines, that really works for primary prevention?
    I have linked to this post, Dr Malhotra’s Independent interview, and Uffe Ravnskov’s analysis of the Catalyst complaints here: http://hopefulgeranium.blogspot.co.nz/2014/05/uffe-ravnskoff-zoe-harcombe-and-aseem.html

    Uffe quotes this draw-dropping statement from one of the complaints – “It was mentioned that those molecules which contain long chains of single carbon bonds are more stable than those containing numerous double bonded carbon groups. Students doing high-school chemistry will be able to tell you the fault in this statement.”
    ‘Nuff said.

  10. avatar Kate Holland says:

    I love you! Keep the information highway clear of misconceptions!

  11. avatar Ash Simmonds says:

    The Catalyst videos are still available on Dr Eades’s Vimeo channel:

    –> http://vimeo.com/user22097885

    I also downloaded them back then in case they were pulled, but not willing to put them on a public youtube as I don’t want my account suspended for copyright or whatever.

    Plus, I kept a copy of the transcript here:

    –> http://highsteaks.com/forum/health-nutrition-and-science/health-and-nutrition-sanity-media-237.msg1077.html#msg1077

    • avatar Zoë Harcombe says:

      Many thanks for this Ash – hopefully it will be difficult to censor the internet! It’s just pretty evil to try…

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