Catalyst crushed?

“A lie gets halfway around the world before the truth has a chance to get its pants on.”
Winston Churchill

ABC takes down Catalyst heart disease episodes after review criticism

Controversial TV program on cholesterol-lowering statins found to have breached editorial standards1

And that, as the Guardian reported, seems to be pretty much that. Here is some of the accompanying text.

‘Two episodes of the TV science program Catalyst will be removed from the ABC’s website after an internal review found the program had breached editorial standards on impartiality.

The controversial Catalyst program on statins and heart disease, The Heart of the Matter, was attacked by health experts even before it aired last year.

The presenter of ABC radio’s Health Report, Norman Swan, warned “people will die” as a result of the TV program’s messages about heart medications.

Swan, whose criticism of the program has been vindicated by the independent Audience and Consumer Affairs Unit report, had said the program made him “really angry” because it might affect Indigenous Australians, who are especially likely to suffer from high cholesterol.’

If this was all you had heard about the matter you would assume that ABC had done a very shoddy job, with sloppy and potentially dangerous reporting. Well, this is all very interesting. However, if you were to criticise sloppy reporting you could start with the Guardian report itself.

To begin with there were two programs, covering different issues, one of which had nothing to do with statins at all. However, the Guardian headline suggests there were two episodes ‘on statins and heart disease’. Not true. The first episode discussed whether or not saturated fat consumption caused heart disease. This episode was called ‘dietary villains’. It had nothing whatsoever to do with statins. The internal review found that this episode contained no errors. (Yet still it is being taken down?)

The second mistake the Guardian made is to accept Norman Swan’s statement that Indigenous Australians are especially likely to ‘suffer from high cholesterol’. Well this is complete rubbish. In one of the very few studies to report cholesterol levels in this population, published in the BMJ, the average cholesterol levels were very low (around 4.4.mmo/l)2. Lower than in any Western country.

Really, dear Guardian reporter, you ought to check your facts before writing such stuff – as should Norman Swan. But hey, checking facts is very time consuming, I think you will find. Moving on, I should also point out that you cannot ‘suffer’ from high cholesterol as there is no level of cholesterol that causes any symptoms. Mind you, if it were possible to ‘suffer’ from high cholesterol then the Swiss, with an average cholesterol level of 6.4mmol/l, would be suffering mightily. [Instead of having an extremely low rate of heart disease.]

Blimey, a few short paragraphs, and this article is already full of cock-ups. Of course, if you decide to go through anything with a fine toothcomb you will be able to pick up all sorts of errors. Writing scientific stuff is not easy. There is always a choice between absolute factual accuracy and providing the broader picture.

There is another choice between which facts to include, and which to exclude. Because of these inevitable tensions, and difficulties, if you want to attack any study, article, TV program, you will always find some traction. Sure as eggs is eggs, any program criticising statins was bound to be attacked mercilessly. Dr Uffe Ravnskov, a long time statin critic, had his book burned live, on air, in a Finnish TV studio. Part of a highly scientific debate, no doubt.

As a disclosure of interest, I did help the programme’s producer, and presenter, Dr Maryanne Demasi with questions and background information whilst she was putting the Catalyst programs together. I tried to give her as much factual information as possible. The day after the programmes came out, I wrote her this e-mail on 31st October 2013:

Maryanne,

Just seen part II. Brilliant, well done…….. I feel a sense of pride being able, in a small way, to help you put this together.

I now hope that you are viciously attacked, because that means you have won. (And it also means that thincs has won). Be ready – I suspect the attacks have already started.

She wrote back on the 4th of November:

Malcolm

OMG!! I am getting attacked in the media. They’re out for blood!!

Where do I hide??!!

Since then, the attacks have been relentless, from many directions. Page after page of criticism from the National (Australian) Heart Foundation (NHF). Withering attacks by the likes of Norman Swan – who seems to have set himself up at the ultimate arbiter of science in Australia. Somehow or other. Despite the fact that he believes people ‘suffer’ from high cholesterol, and has no idea about risk factors for heart disease in Indigenous Australians.

These attacks were battered backwards and forwards until my brain began to overheat. I provided supportive information to counter the criticism. As did several others. Point after point was refuted. It became quite exhausting.

Eventually, it seems ABC effectively caved in and removed the programmes. Why, I am not sure. The judgements on the programmes were almost entirely supportive – with a single exception, which I shall get to. Here, for example, was the commentary on the first programme on the link between saturated fat and heart disease.

Accuracy and impartiality

Episode 1 – ‘Dietary Villains’

The role of dietary saturated fats in heart disease has been controversial since the theory was first postulated at the beginning of the twentieth century. Notwithstanding the lack of definitive proof, mainstream medical organisations such as the National Heart Foundation (NHF) believe there is enough good quality evidence to recommend a diet low in saturated and trans fats…

In our view, the program could have done a better job of teasing out the mainstream perspective to leave audiences better informed.

However, in our assessment this did not amount to a breach of the impartiality standard in the first episode because judgements about impartiality require a number of factors to be weighed. While there were problems with structure and tone:

1. The factual information in the program was accurately presented and the reporter has demonstrated that she diligently sought and considered a variety of views on the subject. No material inaccuracy has been demonstrated by any complainant.

2. The principal perspectives were presented.

3. Neither position was endorsed by the program.

4. Neither perspective was misrepresented.

5. The nature of the program necessitated that the unorthodox theory was given more time and explanation. The Code does not require that they receive equal time, nor that every facet of every argument is presented.

As an important aside, I find it fascinating that the committee accepted that there is no ‘definitive proof’ that saturated fats cause heart disease. Check.

Yet, in a complete rupture of logic, the report stated that the ‘National Heart Foundation believe there is enough good quality evidence to recommend a diet low in saturated and trans-fats.’

Well, if there is enough good quality evidence, there must be, by definition, definitive proof. Either one statement is correct, or the other. They cannot both be, as they are mutually contradictory. This I am afraid is the level of thinking that goes on here. As expected, there is no criticism of the National (Australian) Heart Foundation for recommending a diet for which where is no ‘definitive proof.’ ‘It’s okay, they believe there is enough good quality evidence, and they are good chaps. So that is good enough for me.’

This is the usual kowtowing to the experts. If the roles had been reversed, Catalyst would have been crucified for promoting dietary advice based on nothing at all. Yet, the NHF are completely let off the hook with this pathetic statement.

‘Notwithstanding the lack of definitive proof, mainstream medical organisations such as the National Heart Foundation (NHF) believe there is enough good quality evidence to recommend a diet low in saturated and trans fats.’

Hang your heads guys. What is sauce for the goose should also be sauce for the gander.

And what of other ‘complaints.’ Here is another judgement, from this very, very, long document:

Did the program incorrectly state that it had sought comment from Merck Sharp & Dohme?

Complaint

Catalyst reported that it sought comment from MSD. MSD says that no contact was made.

Assessment

Catalyst has provided emails demonstrating that it approached MSD for responses to a number of detailed questions. MSD replied that it would not comment on the specific questions and stated only that:

‘MSD is committed to ethical research and abides by the principals of good clinical practices. All clinical trials and their protocols undergo review by hospital ethics committees.’

We are satisfied that Catalyst contacted MSD for comment and they declined to provide specific responses to allegations.

Conclusion – No breach of section 2.1.

Basically, MSD lied. They complained that no-one had sought any comment from them. It turned out this was nonsense, they were simply telling porkies. Any criticism of the company? No.

Here is another of the complaints:

Undue favouring of the perspective that saturated fats do not cause heart disease by raising cholesterol – part I – Code of Practice sections 2.2 and 4.5

Complaint

The hypothesis that eating saturated fats can increase cholesterol levels which in turn can cause heart attacks is widely accepted by the medical community and is the basis for most official dietary advice. Some medical researchers and physicians believe the hypothesis is flawed – Catalyst presented and examined their criticisms.

Complaints, including from the National Heart Foundation, allege the analysis lacked balance and omitted critical evidence…..

Assessment

We are satisfied on the basis of our review that the program’s scepticism towards the diet-heart hypothesis was not unjustified and its presentation of an alternative approach did not amount to an undue favouring of that approach.

Conclusion – No breach of section 4.5, no breach of 2.1

Are you getting some sense of what happened here? In point after point, it turns out that the Catalyst programmes had not, in any way, got anything wrong. Nothing, zip, nada. If you are so inclined, you can read the whole report3. To save you the trouble I have pulled out all the complaints, and added in the conclusions in as concise appendix as I can manage. [There is also a short appendix to make it clear what the Codes of Practice mean].

COMPLAINTS

[There were a total of twelve separate complaints, looking at seventeen possible breaches of editorial standards]

1: Ancel Keys’ population studies were misrepresented – Part I – Code of Practice section 2.2

Conclusion – No breach of section 2.2

2: Mediterranean Diet & The Lyon Diet Heart study – Part I – Code of Practice section 2.2 (Did the program accurately describe the Lyon Diet Heart study?)

Conclusion – No breach of 2.2

3: Misrepresentation of the composition of margarine in Australia – Part I – Code of Practice sections 2.1 & 2.2

Conclusion – No breach of section 2.2

4: Inaccurate description of the structure of polyunsaturated and saturated fats – Part I – Code of Practice section 2.1

Conclusion – No breach of section 2.1

5: Misrepresentation of the National Heart Foundation & Dr Grenfell – Part I – Code of Practice section 2.2

Conclusion – No breach of section 2.2.

6: Undue favouring of the perspective that saturated fats do not cause heart disease by raising cholesterol – part I – Code of Practice sections 2.2 and 4.5

Conclusion – No breach of section 4.5, no breach of 2.1

7: Misrepresentation of the 4S trial data – Part II – Code of Practice section 2.2

Conclusion – No breach of section 2.1 or 2.2

8: Merck Sharp & Dohme (MSD) – Part II – Code of Practice section 2.1 (Did the program incorrectly state that it had sought comment from Merck Sharp & Dohme?)

Conclusion – No breach of section 2.1.

9: Unfair characterisation of Australia’s medicines industry – Part II – Code of Practice sections 2.1 & 4.5

Conclusion – No breach of section 2.1 or 4.5.

  1. Failure to provide material context by not disclosing the commercial interests of some of the experts featured – Parts I & II – Code of Practice section 2.2

Conclusion – No breach of section 2.2.

  1. Failure to provide material context in relation to use of statins and undue favouring of view that statins do more harm than good – Part II – Code of Practice 2.2, 4.5 and 7.6

Did the program unduly favour an anti-statin viewpoint in its presentation of the evidence for the benefits and harms of statins?

Conclusion – Breach 4.5; No breach 2.2; No breach 7.6 (4.5 Do not unduly favour one perspective over another.)

  1. The program falsely claimed that the National Heart Foundation had ‘signed off’ on Catalyst’s evidence (PM 31/10/13) – Code of Practice sections 2.2 & 4.4

Conclusion – corrective action required, no breach 4.4

Twelve complaints about seventeen possible breaches of conduct, one upheld (I don’t think I have ever written anything that accurate in my life). There was another part of the report where the judgment is so weird that I cannot understand it. I defy anyone else to understand it either. You can read the whole report if you wish, and see what you think.

It seems to be saying that stratifying risk in primary prevention of heart disease is something that is contentious, but a lot of doctors believe in it, so it should have been mentioned. Something with no evidence to support it, that happens to be believed in by a number of doctors, should be presented as what….the truth? That bit is bonkers. It seems they thought they should say something, but descended into gibberish.

When you get down to it, the judgement is that there was a single breach. Represented thus:

‘The program’s treatment of use of statins in secondary prevention focused solely on mortality benefits in a way that reinforced the view that statins were overprescribed and their benefits exaggerated. The principal relevant perspective that statins have wider benefits for this group was not properly presented. This perspective was necessary to a fair understanding of the pros and cons of statin use in this group.’

Turning this into English. What the committee believe they found was the second Catalyst program ‘Cholesterol drug war’ did not mention that statins have benefits on non-fatal outcomes e.g. non-fatal heart attack, and non-fatal stroke. By failing to mention this point it was judged that the program gave a misleading perspective on the overall benefits of statins (in secondary prevention).

And that, ladies and gentlemen, is that. Perhaps not quite the crushing indictment you thought. Now, you must remember that this committee was starting from scratch, knowing bugger all about the area of statins and heart disease. Given this, they didn’t do too badly. But on the point about non-fatal strokes and non-fatal heart attacks they failed to spot the Elephant in the room. An Elephant that I need to describe to you.

Pharmaceutical companies hide data

The elephant in the room is that, when it comes to data on statins (and most other drugs), we are completely reliant on pharmaceutical companies to provide it. Increasing attempts have been made to get them to release all the data they have, but this has proven virtually impossible. Recently, we have seen a battle over the Roche drug Tamiflu:

‘The British Medical Journal (BMJ) has alleged that pharmaceutical giant Roche is deliberately hiding clinical trial data about the efficacy of oseltamivir (Tamiflu) in patients with influenza. The journal says global stockpiling and routine use of the drug are not supported by solid evidence and alleges that Roche concealed neurological and psychiatric adverse events associated with the neuraminidase inhibitor drug.

In an open letter from Fiona Godlee, MD, editor-in-chief of BMJ, to Professor John Bell, FRS, HonFREng, PMedSci, Regius Professor of Medicine at Oxford University in the United Kingdom and a Roche board member, published online October 29, Dr. Godlee reminds Bell of concerns that were initially voiced in 2009 about the reliability of Tamiflu research.

At that time, BMJ published an updated Cochrane review of neuraminidase inhibitors in healthy adults. That study “took the view that, since eight of the 10 [randomized controlled trials] on which effectiveness claims were based, were never published, and because the only two that had been published were funded by Roche and authored by Roche employees and Roche-paid external experts, the evidence could not be relied upon,” Dr. Godlee writes.’ [From medline, needs registration to view]

To quote the Cochrane collaboration on this matter:

“Patients around the world are being harmed because clinical decisions on their health care are skewed by the absence of clinical trials data,” said Mark Wilson, CEO of The Cochrane Collaboration, in announcing this new partnership. “For 20 years The Cochrane Collaboration has been working to give clinicians, researchers and patients the best possible evidence-based information to help them make informed decisions, and it is a scandal that we still do not have access to all trials data so that we can be confident in our conclusions…”4

Many people find it difficult to believe that companies just hide the data. But they did, and do, and shall do into the future, I would imagine. The 4S study, the single most positive study on statins ever done, by a long way, is more than slightly worrying in this respect. To quote from a blog by Dr Walter Ferneyhough, discussing the 4S study:

‘Did I mention the study bias. Well, it was funded by Merck (the pharmaceutical responsible for simvastatin (a.k.a. Zocor)), was monitored by the Scandinavian subsidiaries of Merck, and the data analysis was performed by Merck. A financial disclosure (conflicts of interest) of the researchers were not given, which is odd, since most studies provide this information.’5

If you believe that there is no possibility that the industry might present biased data, or fail to provide data that is not positive about their products, then you can sleep soundly in your bed…..you poor deluded fool. The reality is that negative studies are not published. Even when a study is positive the ‘raw’ data are held by the pharmaceutical companies. They release what they like, and keep secret what they like. Perfectly legal, so I am reliably informed.

When it comes to statins, this is highly significant when it comes to the issue of Serious Adverse Event (SEA) data. To explain this in a bit more detail, because the terminology here is confusing.

Drugs can cause adverse effects e.g. flushing, pain, headaches. These are known as drug related adverse effects. They are commonly called side effects, but this is inaccurate. A side effect can be positive, or negative.

On the other hand there are Serious Adverse Events (SAEs). SAEs include deaths. They also include nasty things such as a non-fatal MI, or a non-fatal stroke. Things that could be prevented by a statin. So that is good news for statins. However, an SAE could also be an episode of Rhabdomyolysis, or liver damage requiring hospitalisation, or Transient Global Amnesia, or tendon rupture. These could be caused by the statin, and would therefore be bad news for statins.

As you can see, after mortality, SAEs are the next best measure of how beneficial, or harmful, a product might be. Whilst pharmaceutical companies are delighted for us to have the data on positive SAEs, they are completely silent on the data on negative SAEs. Here is what the Cochrane collaboration first had to say on the matter, after they tried to get hold of the data from the statin trials:

Are SAEs reported in the major lipid-lowering trials?

SAE data were sought in the major placebo-controlled trials published up to September, 2001 using statins (5 trials)3-7 or fibrates (5 trials).8-12 Remarkably, only one study, the AFCAPS trial,3 reported total % SAEs in the treatment and placebo groups. In this study, lovastatin was compared with placebo in patients without cardiovascular disease (primary prevention). Similar total % SAEs were reported for the lovastatin, 34.2%, and placebo groups, 34.1% (RR = 1.0 [0.94-1.07]). What this indicates is that the 1.4% absolute risk reduction in total MI or CV death (see Table Letter #27) has been negated by an absolute risk increase in other SAEs. No information is provided as to what these other SAEs might be. The only other trial that reported anything approximating SAEs was the coronary drug project (CDP), a secondary prevention trial. This trial reported the percentage of patients ever hospitalized at 5 years: 55.1% for clofibrate and 52.4% for placebo (RR = 1.05 [0.99-1.12]).

Later on, they had this to say:

‘How can CHD (Coronary Heart Disease) SAEs decrease, but not total SAEs?

All CHD events are SAEs and are counted in both categories. Therefore a reduction in major CHD SAEs should be reflected in a reduction in total SAEs. The fact that it is not suggests that other SAEs are increased by statins negating the reduction in CHD SAEs in this population. A limitation of our analysis is that we could not get total SAE data from all the included RCTs. However, we are confident that the data from the 6 missing RCTs would not change the results, because they represent only 41.2% of the total population and include ALLHAT-LLT10, where one would not expect a reduction in total SAEs; in that trial there was no effect on mortality or cardiovascular SAEs.6

Yes, these reports from the Cochrane collaboration are getting a bit old now. But so are the placebo controlled statin trials, the ones that are used to support all the guidelines on the use of statins. So, when you get down to it, the fact is this. Serious adverse events are simply not reported from the major statins trials, the data are not released.

Which means that the data that are reported are completely skewed. Yes, statins (in secondary prevention) can reduce non-fatal MI and non-fatal strokes. But they increase other unpleasant things by approximately the same amount.

Now, let me take you back to the judgement on the Catalyst program.

‘The program’s treatment of use of statins in secondary prevention focused solely on mortality benefits in a way that reinforced the view that statins were overprescribed and their benefits exaggerated. The principal relevant perspective that statins have wider benefits for this group was not properly presented. This perspective was necessary to a fair understanding of the pros and cons of statin use in this group.’

The committee that sat in judgement of the Catalyst programme was, in my opinion, very fair in the vast majority of what they said. But on this issue they got it terribly wrong. I cannot really blame them, for they probably cannot believe that critical trial data on SEAs are simply withheld. It cannot even be seen by independent researchers.

Because you probably do not believe that this can possibly be true either, I am about to do something that I possibly should not. I have taken advice from a number of people on this, and the views are contradictory. I am about to reveal e-mails that I was sent, and I have not sought permission to do so. Frankly, I know that if I did I would never get permission from all the parties involved [as you will understand once you have read them]. However, I think they are of such enormous importance that people should know they exist, in order to make their own minds up.

The e-mails come from the following discussion. Whilst making the Catalyst programme, Maryanne Demasi contacted Professor Colin Baigent from the Cholesterol Treatment Triallists Collaboration (CTT). The CTT are Oxford based group that hold all the data from the statin trails (Exactly how much, and in how much detail, I have no idea). They are hugely influential, and their meta-analyses form the basis for guidelines on the use of statins around the world. In the UK, the latest NICE guidance will be based entirely on them.

I have known for some time that the CTT will not release the data that they hold, to anyone. But when I speak to journalists they don’t really believe me, much eye-rolling occurs. So, please read on, and find out the truth for yourself. [The only editing I have done to this e-mail trail is to remove all contact details, apart from the address of the CTSU which can be easily found]. You can amuse yourself by spotting the point where the lawyers get involved in drafting the e-mails.

 

To: Enquiries at CTT
From: Maryanne
Sent: 22 September 2013 05:05
Subject: URGENT COMMENT NEEDED PLEASE: ABC TV AUSTRALIA

Hi, I am a medical reporter for ABC TV AUSTRALIA and I am doing a report on statins in primary and secondary prevention.

I have interviewed Harvard Dr John Abramson about the over use of statins within the population and also the lack of transparency of data when it comes to clinical trials.

In the interview he mentions the CTT collaborators being one group who have access to individual data but will not share their data with the public or other researchers even though they’ve been asked.

Prof Rita Redberg from University of California San Francisco supports these statements.

I would like a comment from CTT collaboration regarding Dr Abramson’s and Prof Redberg’s statements please?

Why has the CTT Collaborations refused to release all the data requested of them?

Kind Regards
Maryanne Demasi
Producer
ABC TV AUSTRALIA

 

To: Maryanne Demasi
From: Colin Baigent – CTT
Date: Mon, 23 Sep 2013 21:37:01 +0000
Subject: FW: URGENT COMMENT NEEDED PLEASE: ABC TV AUSTRALIA

Dear Maryanne

Drs Abramson and Redberg are incorrect in stating that the Cholesterol Treatment Trialists’ (CTT) Collaboration has not shared data on the effects of statin therapy in healthy people. Comprehensive analyses of the effects of statins in people at low risk of heart disease or stroke were published (and widely publicised) in the Lancet in 2012, and directly addressed questions about the balance of benefits and risks of statins in such people. The work showed clearly that statins are of net benefit even among those with no previous history of cardiovascular disease.

I would be pleased to discuss this issue with you over the telephone if this would be helpful. I can be reached on +44…

Colin Baigent
Professor Colin Baigent
MRC Scientist & Hon Consultant in Public Health

Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)
Richard Doll Building
Old Road Campus
Roosevelt Drive
Oxford OX3 7LF

 

To: Rita Redberg and John Abramson
From: Maryann
On Sep 23, 2013, at 2:51 PM

Hi Rita and John,

Both of you mentioned in the interviews that the CTT collaborators don’t give full access to their data to public but the deny this. Please see below and respond as soon as possible please?

Many thanks

 

To: Maryanne Demasi
From: John Abramson
24/09/2013

To: Maryanne, Jim Wright

Maryanne,I have forwarded this to Jim Wright, who is the Co managing director of the Therapeutics Initiative in British Columbia. He has direct experience re ctt data sharing. I do not want to speak for him, but I believe he will be interested in the email below from Dr. Baigent.

Best wishes,
John

 

To: Maryanne Demasi
From: Rita Redber
24/09/2013

Publishing data that they have analyzed is NOT at all the same as giving full access to the public, or to other researchers. In whatever they publish, they maintain control and access to their data, the analyses etc. I am referring to the fact that CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins. THe CTT data is not accessible publicly.

Rita

 

To: Colin Baigent
From: Maryanne Demasi
24 September 2013 00:50

Hi Colin, thanks for your time. 

I wasn’t referring to the published data, its the unpublished data. Dr Redberg has been specific:

“Publishing data that they have analyzed is NOT at all the same as giving full access to the public, or to other researchers. In whatever they publish, they maintain control and access to their data, the analyses etc. I am referring to the fact that CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins. THe CTT data is not accessible publicly.”

Comment?

Cheers
 Maryanne

 

To: Maryanne
From: Colin Baigent
Tue, 24 Sep 2013 10:44:01

Dear Maryanne

This is again incorrect. The trials participating in the Collaboration contributed their data to the combined database on the understanding that the data would be held securely and that analyses would be  discussed and agreed by the collaborators before they are conducted. We meet annually, and discuss proposals for new analyses at those meetings. We welcome suggestions for new analyses from scientists who are not formally part of the Collaboration. If, after discussion, such proposals are felt to be scientifically worthwhile (and are feasible) they are conducted by the Secretariat, and the work is shared with collaborators (which then includes those who proposed the analyses).  It is important to recognise that data from participating trials are not owned by the Collaboration, but remain the property of the trial sponsors, so we are not able to provide unlimited access to the combined database. We do, however, provide a mechanism through which the data can be utilised for public benefit.

I hope this is helpful.

Colin Baigent

 

To: Colin Baigent
From: Maryanne Demasi
24 September 2013 13:26

Hi Colin,

Thanks for your moments. I just want to be clear about how i interpret your email.

The data from the clinical trials is “owned” by the trial sponsors – the statin manufacturers.

Hence, the CTT researchers can’t give full disclosure of the data to the public because the trial owners won’t allow them to? Correct?

Maryanne

 

To: Maryanne Demasi
From: Colin Baigent
Date: Tue, 24 Sep 2013 12:30:22

Dear Maryanne

No, this is again incorrect. I think it may be more efficient if you were to call me so that I can explain the process to you. If you wish to speak then I can be reached at the direct line below.

Colin Baigent

 

To: Rita Redberg, Jim Wright, John Abramson
From: Maryanne
Date: Tue, 24 Sep 2013 22:32:28

Hi Dr Redberg, Dr Abramson and Dr Wright

I wrote to the CTT collaborators (Colin Baignet) a second time specifying that its is the “unpublished” data that they are withholding.  His email is below.  Is it possible that I am asking the wrong CTT collaborators?

Am I missing something?

Regards

Maryanne

 

To: Colin Baigent
From: Maryanne Demasi
Tue, 24 Sep 2013 22:09:39

Unfortunately, I don’t have access to a work phone as its late here in Oz.  Also, our lawyers will want to see all these emails to ensure there hasn’t been a misunderstanding or misrepresentation of your position.  I will have to further clarify further with Prof Redberg, Dr John Abramson and Dr Jim Wright from the Therapeutics Initiative in Canada who all claim that the CTT collaborators do not give full disclosure of their data to the public and other researchers.  They have gone on record with this so the matter must be clarified.

Can you explain why they would say something like this?

Maryanne

 

To: Maryanne Demasi
From: Colin Baigent
Tue, 24 Sep 2013 17:02:23

Dear Maryanne

The CTT secretariat has agreement with the principal investigators of the trials and, in those instances where trial data were provided directly by the drug manufacturers,  with the companies themselves, that individual trial data will not be released to third parties.  Such an agreement was necessary in order that analyses of the totality of the available trial data could be conducted by the CTT Collaboration: without such an agreement the trial data could not have been brought together for systematic analysis. Such analysis has allowed the CTT Collaboration to conduct and report all of the analyses on efficacy and safety that have been sought directly or indirectly by others (eg by Dr Redberg in her papers on the efficacy and safety of statins in primary prevention, and in questions raised by the Cochrane Collaboration). Hence, the CTT Collaboration has made available findings that would not otherwise have emerged.

I would be very happy to ring you at whatever time is convenient for you in order to help you to understand our approach, and then address in writing any residual concerns. It would be a shame if we were not able to speak as this would be the most effective way of explaining things.

Please let me know where and some times when I can reach you, and I will endeavour to telephone.

Colin Baigent

 

To: Colin Baigent
From: Maryanne Demasi
24 Sep 2013, at 22:41

Hi Colin,

I am happy to talk to you.  Ive just arrived at work but understand if its too late in London to call you?!

I have to be honest.  I’m not sure why you keep saying my interpretation of the situation is incorrect because the way I read your last email, it tells me that “individual trial data will not be released to third parties”. (that is a direct quote from the email).

I completely understand the reasons why the CTT can not release this information but the purpose of this correspondence was to confirm that the comments of Prof Redberg, Dr Abramson and Dr Wright were factually correct – that they were not making false statements.

They explained that this is the problem with the data from clinical trials – that drug companies “own” the information and will only release what they want rather than having full disclosure of all the data to the public.

Regards

Maryanne Demasi

 

PHONE CALL WITH COLIN BAIGENT NOTES

I had a follow up conversation with Colin.  He stressed that while the CTT made an agreement with the drug companies not to give full disclosure of the individual data to third parties, the CTT had a very important role in providing doctors with the best information available.  He hoped that my report did not undermine the workings of the CTT.

 

To: Maryanne Demasi
From: Jim Wright
26/09/2013

To: Maryanne Demasi

The truth is that Colin agreed for me to send a student to do that analysis in 2007.  When the student Michelle Wong arrived there he would not let her have access to the data and do the analysis.  We would have done the analysis differently and had a better idea of whether the benefits outweighed the harms in low risk people.  I am not convinced by their 2012 analysis, which is based on little or no harm.

Kind regards,

Jim Wright
Editor-in-Chief
Therapeutics Letter

 


Postscript

So now you know that no-one can see the data. Now you also know that the criticism of the Catalyst programme was unfounded. Balance on the ‘non-mortality’ data on statins is impossible as the data on SEAs are hidden. Yes, know the things that statins can prevent e.g. non-fatal heart attacks, but we do not know the equal and opposite things they cause.

The reality is that, if you all did present the data on non-fatal CV events prevented with statins, you would be presenting catastrophically flawed data. Biased, and unbalanced. Yet, Catalyst is told that this is what they should have done.

I know that nothing anyone says will make any difference to ABC now. They just want the attacks to go away. However, I hope that a few thousand more people are now aware of the truth of this matter.

References (may require site registration or membership to access)

1: http://www.theguardian.com/media/2014/may/12/abc-takes-down-catalyst-heart-disease-episodes-after-review-criticism

2: http://bmjopen.bmj.com/content/3/1/e002308.long

3: http://about.abc.net.au/wp-content/uploads/2014/05/Catalyst-Heart-of-the-Matter-ACA-Investigation-Report.pdf

4: http://www.cochrane.org/features/cochrane-signs-alltrials-initiative-campaign-registration-and-reporting-all-clinical-trials

5: http://www.drfernyhough.ca/Cardiovascular%20disease/files/tag-cardiovascular.html

6: http://www.ti.ubc.ca/newsletter/serious-adverse-event-analysis-lipid-lowering-therapy-revisited

 

 

 

67 thoughts on “Catalyst crushed?

  1. dearieme

    The bloke in Oxford seems to keep saying (i) We don’t release the data because we are contractually obliged not to, and (ii) Do stop saying that we won’t release the data because it’s just not true.

    Are his e-mails capable of bearing any other interpretation than this risible inconsistency?

    Reply
    1. Dillinger

      I think he’s saying; “we release all the data we release, we just don’t release all the data, so stop saying we don’t release data, because we release all of it (apart from the data we don’t release.”

      So, that’s ok then…

      Reply
  2. Maureen Berry

    Following this revelation by John Briffa last week, I sent an email to the show’s Producer? expressing my personal disappointment. As man people as possible should do this, I believe. Here is my email.

    scott.mark@abc.net.au;

    I just felt I had to contact you to express my sadness at the decision to remove this documentary from the internet.

    It was honest, accurate and courageous. I have referred many of my friends to it since it was released, people of my age are put under enormous pressure to join the ‘Statin lunacy’ and your documentary succinctly spelled out the ‘alternative argument’ that many people are looking for but struggle to find.

    I cannot imagine the sort of pressure that you, the programme makers and your TV company have been put under by the powers that be, who, for some reason, best known to themselves, have an agenda to ‘medicate the world’ with drugs of limited proven value, with many side effects. All around the world, your programme was seen as being a ‘breath of fresh air’ in the dark world of the lack of debate about Statins, I am sorry to see that it is no longer available on the internet.

    Warm regards

    Maureen Berry

    Reply
    1. Chris

      Good on ya, Maureen.
      Now we can see how fat-headed the pro-statin pricks are prepared to be in order to defend their stance. It is criminal, I think.
      Remember the rationale behind statin prescription is that cholesterol is considered (by adherents) to be an atherogen and capable of inducing growth in atheromas in areas which are troublesome to the heart. Yet cholesterol is a vital and versatile biochemical that does a load of good things like lending structural integrity to cell membranes, being the parent molecule from which healthy vitamin D is synthesised, and it is the foundation for all the steroidal hormones, which makes my sex life more interesting and sensual than a cabbages. So how is it so good in in one moment and so atherogenic in the next? It isn’t ‘bad’ in the next. As the facts have it there is a marked contrast between the properties of cholesterol and those of oxidised cholesterol.
      Oxidised cholesterol is atherogenic, and pure cholesterol is not.
      Irrespective of trial data, with relative benefits greatly overstating the absolute benefits, and with less positive trial data being withheld, the advantages (if any) of statin therapy are being greatly overstated while the disadvantages (and there many illuminated by Dr Duane Graveline) are being completely ignored, while patients or taxpayers money is being taken. In my analysis that is fraud.
      I too fired off an email to wing my sentiments the way of Mark Scott and submitted it beneath Dr Briffas post at http://bit.ly/RFwLSR .
      The more ‘commoners’ that express dissent, the more we share our sentiments upon sites like this, and the more backing we give to the brave people who wrote up cholesterol and statin sceptic literature that we can follow, the greater the prospects that virtue will win in the end.

      Reply
    2. Kevin O'Connell

      I have added my 2 centimes worth today:

      Subject: Catalyst – Heart of the Matter

      Dear Mr Scott

      I was very disappointed to see that you & ABC in general have apparently caved in under unwarranted pressure from the pharmaceutical lobby (the industry and those doctors and experts who derive their living therefrom) and so banished to history those two excellent programmes.

      I have many relatives in Australia and I am disturbed that they might unnecessarily be harmed by statins as I have been here in France. I am one of those ‘1 in 10,000’ (as the statin supporters would have you believe) so affected. Odd that I know so many others who have been, especially with peripheral neuropathy. I still have almost no feeling in either foot (which means some balance problems and a greatly increased risk of falling). That is thanks to the statin and its effects on the mevalonate pathway (basically, they greatly reduce not only cholesterol, but also CoQ10-ubiquinol, vitamin D, the dolichols and more besides, all of which are vital for good health).

      Since changing doctors and ditching the statin (end of 2011) my health has been enormously improved in many ways. Not least, my prostate cancer has been in remission ever since. It had been galloping along while I was taking rosuvastatin. There is a good deal of evidence that those two facts are connected (at least one clear mechanism – lack of vitamin D gives free reign to prostate cancer).

      Anyway, your unnecessary and cowardly censorship of the Heart of the Matter will, I am sure, help condemn even more people to similar suffering.

      Yours faithfully

      Reply
    3. David Bailey

      Thanks for the email address – I have added my experiences and thoughts to his inbox!

      David

      Reply
  3. Marilyn Schroeder

    Fantastic summation. Bravo! Great to have the veil lifted off and see the real story revealed about the spurious attack on these 2 Catalyst programs and on Maryanne Demasi. Thank you, thank you, thank you.

    Reply
  4. Marilyn Schroeder

    P.S. Loads of we Aussies have downloaded our own copies of those 2 programs from You Tube and have happily shared these with one and all on social media. They may be gone from the ABC website however they are alive and well on the internet.

    Reply
  5. Terry

    Dr Norman Swan is also the in house doctor on the Australian version of the Biggest Loser. Speaks volumes about his credibility.

    Reply
  6. Louise B

    I have sent an email too, along the same lines as Maureen. Just out of interest won’t there still be YouTube versions available? Thank you Dr K for this brilliant post. Dynamite stuff. Have tweeted it too.

    Reply
  7. Hants Hippy (@hants_hippy)

    I’ve just read the paragraph below about inconsistencies surrounding statins adverse effect data on Azeem Majeed’s BMJ Blog!! We are clearly being deceived and hoodwinked into being poisoned!!!! Very worrying indeed when we apparently need more convincing to take our daily poison throughout the blog item!

    Finally, what is the true level of side effects from statins? Millions of people are taking statins in the UK without suffering any notable problems. But there are differences in the risk of side effects between clinical trials and in data derived from electronic medical records, with the latter generally reporting higher rates of adverse events in people taking statins than has been reported in clinical trials. This discordance between the evidence from clinical trials and from clinical practice needs to be addressed so that doctors and patients are given accurate information about the risks and benefits of long term statin therapy.

    http://blogs.bmj.com/bmj/2014/05/20/azeem-majeed-three-obstacles-to-increasing-the-use-of-statins-for-the-primary-prevention-of-cardiovascular-disease/

    Reply
  8. Chris

    I have an in-law who was prescribed a statin. He experienced pains in his leg muscles. He was lucky, I think, to have a doctor that recognised symptoms of statin toxicity and allowed him to come off them, though an alternative medication was prescribed.
    I hadn’t met with this in-law in several years and we lately had a small gathering over coffee, etc. I ventured to explain that he know little about cholesterol, and all he has picked up upon has been the negative and one-sided snippets that come with cholesterols bad press. As concisely as I could I explained that in 1976 a group from Albany Med School established that cholesterol is not an atherogen while returning a clear indication that oxidised cholesterol is. I then explained that cholesterol may be oxidised by homocysteine, and that raised homocysteine indicates markedly elevated levls of oxidative stress running in the background. It rests or pivots upon the detoxifying process of ‘methylation’ “, I said, and I went. “Certain antioxidants and antioxidant groups can donate a methyl group (CH3) to radicals (or reactive oxygen species), hence capacity for methylation rests upon a balance of supply and demand of and for methyl groups that can be exchanged between donor (antioxidant) and recipient (free-radical). So if supply falters, or if demand rises, this delicate balance can fail and basal levels of oxidative stress can rise.” I explained I had to check and recheck my facts, but I thought it the case that certain exito-hormones that are glucocorticoids (if levels rise) can place increased demands upon the business of detoxification by methylation, and so raise risks that homocysteine levels will rise, because homocysteine requires donorship of methyl groups to deactivate its radical nature and prevent oxidative stress being commuted to cholesterol and resulting in conversion of some cholesterol molecules to highly atherogenic oxidised cholesterol(s) such as cholestane triol.
    “Hey, be careful, Chris. These are eminent people who back this fat/cholesterol hypothesis; they know their stuff. Of course they are correct about cholesterol”, he replied, real earnest, like.
    “Eminence is no great guide to virtue,” I said, “contact with evidence is so much better.”
    I could see my in-law was not convinced. He defended magic bullets, and he defended pharmaceuticals companies.
    I must let on my in-law has a comfortable retirement. He had a successful career as a cost and management accountant and was employed for many years by Astra Zeneca. His pension is paid for in part, I think, by the profits arising from the magic bullets that induced leg pain in him, and invite debilitating side-effects in 100% of all takers.
    It is sad too few people cannot be brought to see how peculiar is the world we live in.
    I will make it a point to direct him to this thread. Just maybe we statin and cholesterol sceptics can radicalise him. The word must out, and his grandchildren would number amongst the beneficiaries of our efforts.

    Reply
  9. rory robertson former fattie

    Dr Kendrick,

    Thanks for your excellent post, especially for allowing us to view that (previously) secret email trail. Even before seeing that, I found it extraordinary that the ABC had retracted the two Catalyst shows. After all, its own investigation did not recommend retraction, because both shows were confirmed to be factually correct:

    “Recommended remedy
    For Catalyst, the core problem identified in this investigation was omission of important information. Steps should now be taken by the program to provide the necessary additional information to remedy this. We suggest it would be appropriate for additional material to be made available on the special ‘Heart of the Matter’ program website. We also recommend that a future edition of the program refers to ‘The Heart of the Matter’, notes that an investigation has concluded that further important information about statins needed to be provided, and refers viewers to information available on the program website. The program is currently off air, scheduled to return later in 2014. Information can be added to the program website and the ABC Corrections page prior to an announcement being made on the program, if this is necessary.

    For PM, we recommend that an appropriate Editor’s Note be added to the program transcript to acknowledge the inaccuracy, and an entry be made on the ABC Corrections page. ”
    p. 4 http://about.abc.net.au/wp-content/uploads/2014/05/Catalyst-Heart-of-the-Matter-ACA-Investigation-Report.pdf

    Finally, Dr Kendrick, I’m hoping you’ll be able, please, to remove an “n” from the name “Swann” where it appears in your piece above, as the slight mis-spelling is a little off-putting – Dr Swan is a widely known and admired figure in Australia, even if he probably is quite wrong on this matter. If he wants to worry about what is killing local Aborigines and many of the rest of us – besides tobacco and alcohol – he should take the time to have a look at what in local diets is causing problems. Hint – it’s white and starts with “s” but is not salt: Box 2 in https://www.mja.com.au/journal/2013/198/7/characteristics-community-level-diet-aboriginal-people-remote-northern-australia

    rgds,
    rory

    Reply
  10. Clinical Trial Data

    Hi Malcolm, thanks for your informative article.

    A revealing report was released earlier this year from the U.K ‘House of Commons-Committee of Public Accounts’ regarding access to clinical trial information. 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

    I really feel for Maryanne & I’m happy she’s got friends like you to defend her work & her nature.

    Reply
  11. GG

    What an interesting post.

    It seems that the pushing of statins and clinical trials data has become the modern day version of ‘the emperor’s new clothes’ and they don’t want to see what is staring them in the face.

    It seems that a high percentage of doctors are being hoodwinked into becoming drug pushers (for the benefit of big pharma and political points scoring) with patients the victims at their mercy.

    Trying to silence those who bring some common sense to the table will not work in the end. Programmes like these need to be re-run and not hidden away.

    Free choice is no choice if we don’t have access to the facts.

    Reply
  12. Pingback: Catalyst Crushed? Not likely | No Fructose

  13. Archie Robertson

    Great article, Malcolm, and congratulations on your courage in publishing the e-mail chain of evidence!

    I should also commend you on your restraint in not pointing out that Colin Baigent and his fellow academic Rory Collins have received drug company money for research and other purposes totalling over £110 million, and that as a result, anything they say on the subject of any drug should be regarded as untrustworthy.

    Just one minor criticism: the acronym SAE has been replaced by SEA at a number of places, presumably by an over-enthusiastic spellchecker. Is it possible for you to fix these?

    Reply
    1. Dr. Malcolm Kendrick Post author

      Archie. Thanks, I think all SEAs are now SAEs. Cheers. Working full time, writing a book and a blog….my attention to detail falls over from time to time. Nice to have friendly fire pointing these things out. I also put two nns in Swan,

      Reply
  14. Claire

    Great in depth article. Thank you for your quality research where others do such a hack job on important topics such as this.

    Reply
  15. Annique

    The videos of the two Catalyst shows (about 30′ each) and their transcripts :
    “Heart of the matter – Part 1 : Dietary villains”
    https://web.archive.org/web/20131209135030/http://www.abc.net.au/catalyst/stories/3876219.htm

    “Heart of the matter – Part 2 : Cholesterol Drug War”
    https://web.archive.org/web/20131114132733/http://www.abc.net.au/catalyst/stories/3881441.htm

    Watching the shows and sharing any links to where they are archived is maybe a good way to negate such blatant censorship.
    Ash Simmonds’ comment earlier above also has a link to the shows – in it they are mirrored through Vimeo, so in case they vanish there soon I’ve added these two links above to an archive (though it’s anyone’s guess how long that stays up too – except if it gets ‘copied’ ;)) :

    Reply
  16. Laurie L-M

    Here’s another lie, and this might be off topic ( but not really, cholesterol and Lipitor). Statins are a ‘class X, contraindicated in pregnancy.’
    I know you are busy and swamped with information, but I cannot let what I heard today go by. I heard this on the news, and it so shocked me, I have to write this down.

    There is a new ‘study’ linking difficultly getting pregnant with “high” cholesterol. I am just stunned.

    This is one statement (in the news article, not the journal article itself) “From our data, it would appear that high cholesterol levels not only increase the risk for cardiovascular disease, but also reduce couples’ chances of pregnancy.” And this
    “It is known to be bad for the heart. But high cholesterol could also damage a couple’s chances of becoming parents.”

    I try to let this stuff go, but I’m so upset. When they tick me off with the first assumption out of the box – wrong, it can only go down hill from there.

    I was thinking 2 very important things. One is that more young people will think they have to go on brain-dissolving statins (and they are, as you know, disastrous for a developing fetal brain).

    “He added that if other studies confirm the finding, advice on watching cholesterol levels may no longer be centered on the middle-aged and elderly.

    Similarly, young people may be given cholesterol-busting drugs to maximize their odds of having children, the Journal of Clinical Endocrinology and Metabolism reports.”
    And then I think this. While I’m not minimizing in any way the difficulty and pain some individuals have when they struggle with infertility, and I’m not making light of it at all- but as a species, we humans have NO trouble whatsoever reproducing. We are spectacularly successful at it. There is no problem, and ‘ “high” cholesterol’, therefore cannot be the cause of a non-existent malady.

    Reply
      1. Spokey

        As busy as I am at the moment, I’m glad I can still find time to get so mad about this insanity my blood pressure becomes a potential hazard to people working within a ten meter radius who might get hit by shards of bone and high velocity chunks of meat when I finally pop from the outrage. That.. that can’t actually happen can it?

      2. elenor5

        No, it won’t; because they will find a way to blame any defects on anything-but-statins!!

    1. S Jones

      It used to be well known amongst doctors that high (or higher than average) cholesterol is frequently found in people with an underactive thyroid. It used to be well known amongst doctors that having an underactive thyroid has a big (negative) impact on fertility.

      It is much more likely that a connection between low fertility and high cholesterol levels is caused by thyroid problems. But thyroid problems are neither sexy nor profitable, so the statins will get people excited, babies will be born damaged, and Big Pharma will make some more billions.

      Do I see another thalidomide tragedy in the making?

      Reply
  17. Mark John

    I’ve mulled over this quite depressing state of affairs for the past couple of days. How can so few have such an influence over independent and prestigious medical publications such as the BMJ and Lancet, never mind television companies?

    Reply
  18. nnmlly

    This is inspired work, and much appreciated. Have you sent the link to Dr Ben Goldacre? I am sure he would enjoy reading it. Anna

    Reply
  19. Jules

    Last week I watched a BBC2 documentary about the 50 year fight to get the pharmaceutical companies to admit liability over thalidomide and there could be no doubt about the SAEs there. SAEs in statins seem to be, in some instances, more insidious, particularly when the age at which they are commonly prescribed could account for many of them. I don’t imagine the statin debate will go away anytime soon, we just need to keep plugging away, and stay informed. Thank you for the blog.

    Reply
  20. Maureen Berry

    Got a reply:

    Dear Ms Berry,

    Thank you for your email.

    Both episodes of Catalyst’s ‘The Heart of the Matter’ were reviewed by Audience and Consumer Affairs, an independent unit that reviews ABC programs to assess whether they meet our editorial standards. These standards are necessarily high, consistent with what Australian audiences expect from their national broadcaster.

    Following a thorough review of the programs, Audience and Consumer Affairs concluded that there had been a failure to meet these standards.

    The decision to remove the programs was made by senior management and the Board having regard to the seriousness of the subject matter and the possible health implications. There has been no diminution of the ABC’s editorial independence and I have in fact encouraged our science journalists to continue to investigate and report on this subject in accordance with our editorial policies.

    Yours sincerely,

    Mark Scott
    Managing Director

    Convinced? No, me neither!

    Reply
    1. Kevin O'Connell

      I got exactly the same reply, word for word. Do you suppose they’ve set up an automated system to deal with us all?

      Reply
      1. Dr. Malcolm Kendrick Post author

        I thank you for your contribution to my blog. As you know patient safety is my number one priority. I strive at all times to ensure that the content of this blog is of the highest scientific quality….(message ends)

  21. Chris

    “Both episodes of Catalyst’s ‘The Heart of the Matter’ were reviewed by Audience and Consumer Affairs, an independent unit that reviews ABC programs to assess whether they meet our editorial standards. These standards are necessarily high, consistent with what Australian audiences expect from their national broadcaster.

    “Following a thorough review of the programs, Audience and Consumer Affairs concluded that there had been a failure to meet these standards.

    “The decision to remove the programs was made by senior management and the Board having regard to the seriousness of the subject matter and the possible health implications. There has been no diminution of the ABC’s editorial independence and I have in fact encouraged our science journalists to continue to investigate and report on this subject in accordance with our editorial policies.

    “Yours sincerely,
    “Mark Scott
    “Managing Director

    Just possibly Mark Scott was a closet sympathiser all along, or maybe people power had him capitulate, but annoyingly higher ‘editorial standards’ are being applied to dissenters than was ever applied to the establishment of an aberrant consensus surrounding fat and cholesterol. Hey-ho.

    Reply
    1. Ash Simmonds

      Here’s where it falls apart – episode 1 isn’t making any particular health claims, it’s simply pointing out that every single guideline we have imposed upon us has no evidence behind it.

      They never said “here’s what you should eat to be healthy”, they are just shining a light on the house of cards the status quo thinks should remain unexamined – and the fact this program reached something like ~10-15% of the adult Aussie population, well…

      A quaint personal story – a few years ago my mum was sick and tired of being fat sick and tired, I convinced her to modify her habits to be a loose keto diet – not that she knows it – she’s just always loved her meat with all the fat and butter sauces etc and so was willing to believe me when I told her to ditch the veggie oils and sugars and breads – but she still enjoys a pizza “cheat” once every week or two, no biggie. Anyhoo within 6 months she as a 50-something was in the best shape and feeling better than she ever had since her 20’s.

      She never really cared for the science or reasons, but just trusted that I knew what I was talking about and enjoyed not agonising over what she ate as long as it was basically meat and veg mostly. Anyhoo when they aired ep 1 last year she was staying with me and we watched it together – she was absolutely blown away, seeing all the stuff I’d rambled about here and there over the years being put in a concise half hour “here you go” that she could understand and gel with.

      In mum’s case the program wasn’t telling her what to eat or how to live – it was simply freeing her to see “an authority” in mainstream media demonstrate that the authorities have no place telling us what to do.

      VIVA LA BACON!

      Reply
      1. GG

        But surely that is the point – the guidelines we are given are very flawed with no proper evidence to back them up? And yes we need to know this rather than being told what to do. Eating healthily is not governed by what we need to be healthy. I am convinced that economics and the need to promote farming industries around the world have more influence on eating healthily guidelines than we might be getting told.

  22. Jennifer

    Dr K. Your debacle with ABC is one example of the dreadful interference whereby honest science is being denied to the public.
    Another example is Dr John Briffa’s excellent stance against NHS Choices’ prevarication regarding their duff info; their excuse seems to be…….the thicko morons couldn’t understand hormones, so don’t confuse their little brains with stuff that might contradict unscientific guidelines.
    Then there is the contrived criticism of Dr Malhotra’s article in BMJ, a mealy-mouthed effort to distract us from the real issue that Dr M. was correctly highlighting.
    In January, Dr Lustig’s brief portrayal on British TV, implied he is a buffon at the fairground, rather than according him the respect that his primary research has exposed on the harmful effects of sugar and fructose. Don’t let the facts get in the way of futile entertainment, as the public couldn’t handle it.
    Like I say, we are being denied access to good science because somewhere out there, there are movements hell bent on keeping us ill-fed, unhealthy and dependent on bad, so-called ‘foods’ and unhelpful medications.
    Why? to keep profits bouncing along at unprecedented levels.
    Utter TISH….(polite, old-fashioned Nurses’ parlance, for you-know-what!)

    Reply
  23. Dr John Barr

    Hi Malcolm
    I’m a GP in Australia, and the response to the Catalyst program took about 3 days to muster, and then the usual suspects weighed in. The National Heart Foundation, run by Big Food and Big Pharma, along with several “Key Opinion Leaders” were on the mainstream media and the medical rags, with multiple horrific warnings about how thousands of people were being condemned to early deaths if they stopped their statins because of the programme.
    A lot of my patients are of the opinion that the evidence for NOT taking statins is certainly as strong as the rubbish for taking them. They are fascinated by the figures regarding light fluffy LDL molecules versus small dense ones and ask why that is never mentioned by their cardiologists, and also why they are peddled the simplistic view bandied about by the statinators about lowering the LDL, along with the saturated fat nonsense.
    I was very interested to see Zoe Harcombe’s figures about the funding of the CTTC, although when I clicked on the link, I couldn’t find the declaration of interest she mentioned about Colin Baigent. For $116 billion, even spread over a 10-15 year period, it is easy to see why the group are so pro-statin
    Please keep up the good work. Eventually the whole thing will be exposed for the scam that it is, hopefully along with a whole lot of other industry backed and funded lies. Bisphosphonates anyone?

    Reply
    1. CJP

      “A lot of my patients are of the opinion that the evidence for NOT taking statins is certainly as strong .. “
      Hi Dr John,
      Your patients are better informed that the majority, but they are not as well informed as they could be.
      The rationale fro prescribing statins rests upon their designed capacity to reduce the amount of cholesterol that is synthesised (mainly in the liver) from mevalonic acid, and this cholesterol reducing aspect is an appealing feature because cholesterol is assumed to be an atherogen. By ‘atherogen’ I mean a substance capable of inducing growth in atheromas (or atherosclerosis – fatty plaques). That cholesterol is considered an atherogen originates from a confounding error present when cholesterol was first fed to rabbits (1913). It took until 1976 to clarify the situation, and it was then that cholestane triol (oxidised cholesterol) was atherogenic while pure cholesterol (cholesterol not despoiled by the presence of oxidised cholesterol(s)) is not in the least bit atherogenic.
      The case for lipid modification (lowering cholesterol by prescribing/taking statins) rests upon a confounding error that has been exposed yet too few people take account of.
      So.
      Statins do not target the cause. They mess with lipid profiles with no promise of benefit and every risk of complication, plus by interfering with synthesis of mevalonic acid they interfere with the biosyntheis of other important derivatives of mevalonic acid including dolichols and CoQ10. Statins interfere with at least five other biochems without need and without regard for consequence. Physiological consequences are inevitable, while any benefits are left to chance.
      If you have a body in Oz that issues guidelines to GPs and advices under what circumstances statins should be prescribed, .. and if they have a calculation tool to aid the decision, .. and if that calculation tool includes ‘age’ as a risk factor, .. and if that tool makes reference to results from a lipid profile test, .. then rest assured the people who put those guidelines together cannot know their cholestane triol from their cholesterol ( and I should wonder if they could distinguish a coccyx from their humerus). I do not know if it is the case in Oz but there are territories of the world in which the guidelines encourage malpractice rather than care and clinical excellence.
      If I were a GP I’d be spitting feathers at the general delusions surrounding statins, and I’d be hopping mad over the Godlee/Collins affair – in which Rory Collins exerted undue eminence upon editorial standards at the BMJ, and under the pressure of which Godlee caved in, and quite unnecessarily.

      Reply
      1. Frances Brooks

        OZ girl – afflicted by Statin x 4 including a duo – protracted ingestion amidst constant patient severe adverse effects alerts – to no avail – ceased of own volition – after twelve months respectively: Now barely able to operate farm alone – as did prior – cross country ski endurance training prior – building house prior – remote farms visiting nurse prior: All negated by above ingestion: Loss of impetus and inertia – I believe to be the core of culpability – Neurological interruptions; accompanied by;Transient Global Amnesia – muscles and joints atrophy – heart fatigue – and rapid ageing: I intend to – not – plagiarise – but add your notes to a Medical Research Email am sending to the Culpables ( Doctors involved ) it was arduous finding you once more as too tired to evaluate late last night – and difficult to track you today – success! A brilliant rendition of recipe for disaster – thankyou so very much for your valued input: Frances:

    2. Jennifer

      Dr Barr…..Yes, and my question is: who can we turn to to help us honestly decipher the shocking effects of many treatments swamping the worlds of the animal and mankind kingdoms?
      Never mind FAD DIETS…..let us consider FAD PHARMA!
      The mismanagement and inappropriate prescribing of certain classes of drugs, is an absolute scandal. Just look at the careless use and abuse over the last 60 years of:-
      antibiotics, thalidomide, barbiturates, opioids, amphetamines, steroids, oral contraceptives, SSRI’s, H2 receptor antagonists, PPIs, diphosphonates….and not to mention statins, antihypertensives, oral hypoglycaemics, aspirin, NSAIDs..etc etc.
      All these examples may have had a beneficial application in the short term, but by over prescribing, and indeed, inappropriate use, have been shown to be harmful.
      Now, please do not think I am a Luddite. Progress in the medical world is essential, but my less than comprehensive list proves the point ……that the unsuspecting public have been exposed to FAD PHARMA at a detrimental cost to their health, coinciding with the exponential wealth of the producers.
      Our diets have been devastated. The chemists have been looking for remedies for diseases caused by malnutrion; then they have been looking for remedies to combat the bad effects of those medications!
      So….lets get back to basics…..let food be thy medicine….now who first coined that phrase? I must be older than I want to admit to, or am I just living in the past?

      Reply
      1. CJP

        Hi Jennifer,
        Yours are good points and I especially like the minting of the expression. ‘FAD PHARMA’.
        The greatest problems facing medicine and medical science lies with the crush to find treatments and deliver them, which is the sense you infer in me, plus, this goal works like a revolving door. Once the treatment is accompanied by newly appeared rivals, and as the protection of the patent wears off, those that developed the treatment find their enthusiasm on the wane, then the search is on for the next big thing.
        If we look at things historically BIG PHARMA began quite small. It’s early challenges were to ward of the kind of infections that accompanied a rise in population density living in squalid conditions. But even in cleaner living conditions urbanisation and rising density of habitation increases risk of contracting communicable diseases. The development of antibiotics and vaccines were the early bread and butter for PHARMA, and on balance the early advances were good ones. Several troublesome and communicable diseases were all but eradicated. One great success was cholera.
        However cholera was not defeated by the development of a treatment that could inoculate against the disease. Cholera was defeated by engineering. Cholera was defeated because John Snow identified the CAUSE, which paved the way of defeating the condition by the solution of avoiding exposure to the cause. It meant separation between water supply and waste water (contaminated by human waste) had to be restored. Sewers were the engineering answer.
        A new class of diseases has emerged in human societies, especially in those that are highly urbanised. Medical science tends to refer to these newer diseases as ‘non-communicable’, or even ‘chronic’, but ‘non-communicable’ a misnomer. It would be better to have called these new diseases response to environment conditions. I guess medicine thought, and still does, that you cannot catch a chronic disease, but indeed you do.
        Our body was tuned by the process of evolution to appreciate certain ‘living conditions’. By ‘living conditions’ I don’t so much refer to qualities like room size and carpets as I infer the attributes that the environment we live in sends our way. Our body is designed to be responsive, and we humans are lucky for being versatile and adept, which means we can adapt quite well to alternate habitats. These traits permitted expansion of humans and proto-humans out of Africa. Dark-skinned early humans that took up residence in latitudes possible in Eurasia found themselves deficient in a hormone called vitamin D (that’s made from cholesterol btw by the action of sunlight on the skin) With high levels of natural sun-block (melanin) there was not enough scope to manufacture vitamin D, especially in cooler, temperate, and largely forested regions. Through evolution they developed fair skin. Dark skin had been an earlier development stemming from proto-humans losing their fur and running upright and ‘native’ about the savannah.
        London is world of contrasts. There is no shortage of light. You can leave the lights on 24 hours if you wish. Despite this even fair-skinned people living in London can find it a challenge to synthesise enough vitamin D because vitamin D requires the kind of light only available outdoors from April to September (or thereabouts). Working indoors has become the norm, going by tube or train has become the norm, and even sleeping by day has become the norm. And when we do sleep it can be tricky to escape the light. Oh yes, and the typical diet of a Londoner (as an example) is not what it was in the stone age.

        So….lets get back to basics…..let food be thy medicine….now who first coined that phrase? I must be older than I want to admit to, or am I just living in the past?

        Yours is an excellent point, Jennifer, and the point is this, you are NOT living in the past and your hormones an detect this. The conditions of the present do not equate to those which evolution prepared them for and so they make adjustments whose balance has not been coded into what’s ‘right and proper’ on their terms.
        Too much carbohydrate, not enough saturated fat, and willingness to over-consume polyunsaturated fatty acids all brings about physiological disturbance by small increment rendering prospects of damage by advanced glycation end-products (AGEs) more likely, and oxidation of PUFAs more likely too. People can trend to chronic hyperinsulinemia which almost guarantees that individual will trend to becoming a patient. Aspects of the dietary balance has implications for hormonal balance, and its the dietary choices of the present that can be disruptive.
        Crucially, affairs other than diet can bear upon hormones, and rather paradoxically light is an issue. By disturbing levels and rhythms of cortisol, exposure to artificial light brings a bout a cascade of disruption. We spend to much time in the light (artificial light), then through sitting up we don’t spend enough time sleeping, and when we do sleep the room may not exclude enough light. All this has consequence for cortisol and a cascade of hormones that follow, and its my believe these imbalances can raise background levels of oxidative stress. But in contrast to the changes the invention of the light-bulb has brought about we no longer spend enough time outdoors and we no longer give enough opportunity for the synthesis of a powerful antioxidant, vitamin D. When we do go out many of us burn, Counter-intuitively burning is evidence of not getting modest exposure often enough, and if levels of vitamin D were adequate melanin (tanning) would arise more easily.

        We’re exposed to stress, far more stress, far more often, and stemming form modern sources than compared to the stone age. And a recent development is isolation. Actually ‘isolation’ can take at least two forms. There is social isolation which appears paradoxical when compared to the trend of social density. But a development within the last century is that our level of electrical isolation from ‘earth’ is now total. We never go barefoot on good ground. We miss out upon a source of highly antioxidant free-electrons. Cationic biochemical species (sometimes these fit the description of free-radical) are allowed to proliferate, and the body can take on a detectable charge. This happens because our homes, our workplaces, our vehicles and the materials used in the manufacture of footwear insulate us electrically speaking, from ground. If we took the trouble to earth ourselves we could observe this charge fading in real time with use of an electrode patch and a simple voltmeter.
        Carrying this charge that builds up in the absence of contact with ground has consequences for body chemistry. Aspects of body chemistry relies upon ions (which are electrical charges) to influence certain reactions Zwitter-ions are slightly enigmatic. The balance of charge about a zwitter-ion alters in response to the balance of chemistry (pH) that surrounds it. So the way zwitter-ions respond (interact/react) is influenced by the immediate environment in which they swim. This is cutting edge stuff, and there is much that is not known. But the next bit should be of interest to DR KENDRICK.

        Dr Kendrick is a convert to homocysteine testing. Homocysteine is a reactive little molecule that can wreak havoc. It seem very plausible it, above all others, is the potent oxidising agent that can oxidise our cholesterol (which is what really causes damage to our arteries). Homocysteine results from and indicates (in most cases) that antioxidant methyl groups (CH3) are in short supply compared to demand), and it points to wards certain B group vitamins in the main. But homocysteine is also an identified zwitter-ion.
        That homocysteine is a zwitter-ion ought to have certain alarm bells ringing. Might the potency of homocysteine be a variable subject to the balance of the chemistry in which it swims. The way i would pose this question is this, “Do elevated levels of cationic duress, and that additional detectable positive charge about the body, incurred through shortage of anti-oxidant free electrons render homocysteine a more potent oxidant?” A fiver deposited at the bookies would not be wasted, I reckon.

        I really want to endorse your view, Jennifer, for your intuition has your mind trend very much in accord with the truth. Modern medicine spends a lot of time treating chronic health conditions which it, and we, have tended to think are inevitable with advancing years. The reality is that modern doctors spend a disproportionate amount of their time treating health conditions which could easlily be described as man-made. Weston Price was among the first to figure this, then the late Barry Groves took understanding to new dimensions. There is a lot about modern food that grates with human physiology. But a legacy of the aberrant fat/cholesterol hypothesis is that too many holes have pinned pinned on the diet and lifestyle cards, (and the guidance upon diet has it backwards about anyway), yet as can be gleaned in a relatively short exposition things other than diet contrast with the past and do not represent conditions or hormones and physiology would find ideal. GPs could afford to be far more naturally oriented in their approaches. Compared to the stone age there is alot about the 21st century that is to be appreciated, but there are elements (ones that could easily be redressed) present in the 21st century that grate with our stone age physiology.

        Evolution of the human runs at a much slower pace than does evolution of another kind found within human societies. The stress commuted the way of hormones commutes to stress borne by the epigenome, and it seems even our genome may be afflicted. They are insistent on directing us to believe we defective genes. We do not have defective genes, not in the main. Our genes are the most adaptive and adapted asset we have, in the main. What we have fashioned is a man-made environment — aspects of which our genes, epigenome, hormones and other aspects of our physiology perceives as maladaptive. Intelligent people (this is not directed at you Jennifer) need to wake up. IT’S THE ENVIRONMENT, STUPID !

  24. Professor Göran Sjöberg

    Thank you for fighting this uphill battle!

    Ideas of societal conspiracy are revolting to me but I am constantly being pushed into believing i that this is actually what is going on in pharmacy and health care.

    But what is the level of corruption which a society can sustain without falling apart?

    Reply
    1. CJP

      “Ideas of societal conspiracy are revolting to me but I am constantly being pushed into believing i that this is actually what is going on in pharmacy and health care.”

      The conspiracy is not one of minds colluding, instead it originates with need to find ‘markets’. You see the needs of the many can be provisioned by the few, this is the result of all the gains in efficiency and proficiency made by increment since the stone age, but the rewards for idling away our time are few. The constraints originate form the ‘operating system’ running in the background and this boils down to the relative distribution of wealth and indebtedness across society.

      It isn’t actually the lure of money that makes us competitive, mercenary, and cynical, it is actually insecurity that stems from the scarcity of money. Only a minority can afford to take it easy, while the rest of us must work. There is not (now) enough ‘real’ work to go round, and so within the economy is a strong incentive to find new products and new markets.

      If a brand of paint ‘does exactly what it says on the tin’ then the product lives up to its claims, but there are goods and services offered that fail to match all the claims made for them. Some claims are complete fiction. Statins rank as an example of a ‘fictional market’. Stains live up to all their financial expectations but there actual clinical benefits fall far short of the claims made for them.

      Circumstances associating with the relative distribution of wealth and indebtedness (and other associated variables) conspire to have people behave in ways which manifest themselves in sociological eventualities.

      “But what is the level of corruption which a society can sustain without falling apart?”

      Navigate to Bernard Lietaer .com. There are resources can be found from there that will help. In one published paper Lietaer and others liken circumstances described by the 2008 banking crisis as those preceding the 1939-45 conflict. I agree and wound up thinking much the same if having got there through chugging under my own steam.

      Instability arise because all those efficiency and proficiency gains made since the stone age have not resulted in enduring security. The wages of the workers are seen as a cost in production. it it ceases to be the case that ongoing money supply cannot be maintaned in keeping with need then workers suffer wage repression and the ‘quest for value’ comes to the fore. Food seemd expensive, but really it is wages that are artificially low. When wages cease to afford the necessaries of life people get ‘ansty’ and frsutration, then conflict may follow. politics becomes dysfunctional and despots rise to power. What happened in Germany in the 1930s fits this process, and it is ongoing in regions now, (Egypt, Syria, Ukraine etc.)

      WWIII is actually ongoing (over cholesterol) and the prospect of contagion to WWIV is a real possibility unless we (humanity) fix (fixes) the problem.

      The underlying principle to respect in science is that ‘effect’ does not arise without ’cause’, Goran. That ‘things’ can conspire to result in ‘eventualities’ should no longer seem such revolting notion.

      “About this much, and no more” : A far better answer than mine.

      Reply
      1. Professor Göran Sjöberg

        Well – I had to scratch my head and start thinking about what the word “conspiracy” really “meant” but today it is easy to instantly become an expert on whatever by Google and Wiki and here it goes:

        “A conspiracy theory is an explanatory proposition that accuses two or more persons, a group, or an organization of having caused or covered up, through secret planning and deliberate action, an illegal or harmful event or situation.”

        This seems to me to fit pretty well with the actual Catalyst issue and, by the way, on all twisted clinical RCTs, as far as I understand, on the statins (as well as what is happening in the “science” of psychopharmacology – “Mad in America” by Robert Whitaker made that pretty clear to me).

      2. Dr. Malcolm Kendrick Post author

        Like many words. Conspiracy carries rather too much emotional baggage to be helpful. I tend not to use it, as you paint yourself into a corner when you do so.

      3. David Bailey

        I agree in a general sense with some of what you have written. I feel that we have organised society in a way that suppresses honesty and concern for others.

        As an example, suppose you work for McDonalds, and you decide to discourage people from buying large soft drinks because you know they are full of sugar and bad for their health. You would get a stern warning and an ultimatum – sell as much as possible, or get out.

        Now suppose you are the manager of a McDonalds franchise and decide to curb the sales of sugary drinks – someone higher up the organisation will undoubtedly give you the same ultimatum.

        Even if you are the managing director of McDonalds, you still can’t implement a healthy policy regarding sugary drinks, because if you do, you are immediately forced out by pressure from the shareholders.

        Since most shares are held by large corporations, even the shareholders can’t express higher ideals – they work for their corporation!

        I’ll bet that at least some of the people working on statin development (say), are very troubled by what they know, but even they are replaceable, and if they speak out, they may not even get a job outside industry – say in a university – because would be seen as troublemakers.

        Western market capitalism seems to be hitting the buffers – if the banks can crumble and we take no notice – what hope is there!

      4. Dr. Malcolm Kendrick Post author

        David. I agree with much of what you say. Capitalism could be considered as displaying the behavior patterns of a psychopath. No compassion, no empathy, no concern for others. Just, ‘make money’ or else. Which is why, I suppose, the top end of many companies has a very high ratio of psychopaths/sociopaths. In fact, at one point, some banks were actively seeking to hire people with a high psychopathic tendency, as their ruthless pursuit of money and power were considered the very characteristics most likely to earn profit. As described by John Ronson in his book ‘The Psychopath Test.’ It is incumbent upon our Governments to ensure that the worst excesses of capitalism are brought under control.

  25. Anne O'Neil

    I have to say that having watched the videos after Zoe Harcombe shared a link to them, I did enjoy them. I found that rather than being biased to either side, the only reason I felt that the argument against statins appeared more “prevalent” was because the people speaking on that side had evidence and the courage of their convictions on their side whereas the “pro statin” group appeared to be terrified of getting asked a tough question on why they stuck to their opinion…. just my thoughts

    Reply
  26. David

    Did anyone put it on Youtube in the period before it was censored – ahem, sorry, “withdrawn for editorial reasons”?

    Reply
  27. Mike Wroe

    Dr Malcolm

    If you haven’t already done so (and I have somehow missed it!) could you commend on the reported “Gene Test for Heart Risk Rolled out” news item on the BBC website 28th May please. The DNA blood test aims to “spot” the one in 500 people who have FH. Is Big Pharma paying for this test to help their relentless propaganda?

    Thank you

    Reply
  28. Mike Wroe

    Dr Malcolm

    If you haven’t already done so (and I have somehow missed it!) could you comment on the reported “Gene Test for Heart Risk Rolled out” news item on the BBC website 28th May please. The DNA blood test aims to “spot” the one in 500 people who have FH. Is Big Pharma paying for this test to help their relentless propaganda?

    Thank you

    Reply
  29. Pingback: Fat Head » The (Statin) Empire Strikes Back

  30. Pingback: The (Statin) Empire Strikes Back | Bydio

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