Monday, May 19, 2014

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

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.

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
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?

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).
BayerA mere £965,000
John Wyeth Ltd£500,000

That’s £114 MILLION before you get into the small change.

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="" an="" available.="" be="" cardiovascular="" disease.="" fact="" important="" is="" of="" openly="" p="" risk="" this="" to="" which="" year="">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.
Read the complete article here.

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