“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.
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.
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.)
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
