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At one stage I was cut off when I attempted to bring up the issue of financial conflicts of interest amongst the authors. The lead author of this paper was Professor Sir Rory Collins. In truth, I have been awaiting this article for some time. In fact, I am going to reproduce here a blog I wrote on February 1. A humiliating climb down . He, more than anyone, has championed the ever wider prescription of these drugs. He has also ruthlessly attacked anyone who dares make any criticism of them.
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You may remember that last year he tried to get the BMJ to retract two articles claiming that statins had side effects (correctly called adverse effects, but I will call them side- effects to avoid confusion) of around 1. A game I have long since tired of. Is this story ringing any bells yet? The truth was that both articles quoted a paper which stated that 1. So, yes, a pedant would say that the 1. Certainly not worth a demand of instant retraction, and apology, which is a very drastic step indeed. Anyway, below is a short description of the findings of an independent panel set up by Fiona Godlee, editor of the BMJ, regarding the Rory Collins attacks.
Although The BMJ issued a correction for both papers for inaccurately citing an earlier publication and therefore overstating the incidence of adverse effects of statins, this response did not satisfy Collins. He repeatedly demanded that the journal issue a full retraction of the articles, prompting The BMJ. The error did not compromise the principal arguments being made in either of the papers.
These arguments involve interpretations of available evidence and were deemed to be within the range of reasonable opinion among those who are debating the appropriate use of statins. The panel considered this unlikely to promote open scientific dialogue in the tradition of the BMJ.
He claims he signed non- disclosure contracts with pharmaceutical companies who send him the data, so he cannot allow anyone else access. Please remember that some of the trials he holds data on were done over thirty years ago, and the drugs are long off patent. So how the hell could any data still be ? But that is an argument for another day.
Then try to make sense of it. So, they have got the data, but not bothered to look at it? Or they have not got it . Either way, Collins states he has not assessed it.
Despite this, he still managed a vicious attack on the BMJ for publishing articles, claiming statins had side effects of around 2. This was an interesting stance to stake, as he now claims he has no idea what the rate of side effects are? In which case he should make a grovelling apology to Fiona Godlee immediately. What is certain, and must be reiterated, is that Rory Collins has consistently refused to allow anyone to see the side effect data, or any other data, that that the CTT may, or may not, hold. See e- mail below from Professor Colin Baigent to the ABC producer Mary. Anne Demasi (she was trying to get the CTT to confirm that they would not release data, Colin Baigent is, or was, deputy to Rory Collins)From: colin.
To: maryannedemasi@xxxxxxxxxxxx. Subject: RE: URGENT COMMENT NEEDED PLEASE: ABC TV AUSTRALIADate: Tue, 2. Sep 2. 01. 3 1. 7: 0. 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. I put the word safety in bold in this copied e- mail. You will note that Professor Colin Baigent does not say that that the CTT do not have these data on safety.
He just says that the CTT won. If they do have it, why have they not done this critically important review before, as they have had much of the data for over twenty years. Sorry to keep repeating this point, but I think it is absolutely critical.
Picture the scene in a lovely oak panelled office in Oxford, the city of the dreaming spires. This review shall, in Collins own words .
Nothing to see here, now move along. A. N. Other Researcher: . Data that no- one else can ever see. He might even be the last. P. S. Actually, he would be the last. I do not claim to be Nostradamus here. What was going to happen was obvious.
The script had been written a long time ago. It was only a question of when, not if, it happened. However, whilst the article itself is nothing new. Just the same data stretched into three hundred references, and mind- blowing statistical obfuscation. It does, however, contain a few new Alice in Wonderland statements, such as the following: ?
For the first twenty years of trials on statins, no- one had noted that statins increase the risk of type II diabetes. It was not, as far as could be seen at the time, a problem.
Then, in a later study, JUPITER, all of a sudden it was found that there was a significant increase in type II diabetes. Now, it turns out that all statins increase the risk of type II diabetes. Had JUPITER not recorded the incidence of type II diabetes, this would never have been noticed. The cynics among you might say that they recorded this in the hope that the incidence would actually go down. Here we have a perfect example of an outcome not recorded in the vast majority of statin studies. Had it been, it would have significantly biased the assessment of treatment. We also find that after two trials, 4.
S and HPS, found an increase in non melanoma skin cancer. Outcomes certainly cannot make a difference if you do not record them. But if you did bother record them . However, the purpose of this blog was not to discuss the evidence, such as it is, such as we are allowed to see, but to highlight why this paper was written and published. For this I shall turn to the editorial, accompanying the paper, written by Richard Horton. Who is the editor of The Lancet.
Read this, and be afraid, for it is the most frightening thing you will read this year. Possibly this decade and maybe the entire century as is a direct attack on human freedoms. Whilst couched in the usual life destroying scientific prose, what he is saying is that any who questions current accepted medical dogma should be very tightly controlled, and probably should not be allowed to publish anything at all.
The entire editorial is an exercise in trying to silence any dissent with what some might view as threats and bullying. This, I think, is the key paragraph (my emphasis in bold). Some research papers are more high risk to public health than others.
Those papers deserve extra vigilance. They should be subjected to rigorous and extensive challenge during peer review. The risk of publication should be explicitly discussed and evaluated. If publication is agreed, it should be managed with exquisite care.
They should be subjected to rigorous and extensive challenge during peer review’. Editors and scientists alike insist on the pivotal importance of peer review. We portray peer review to the public as a quasi- sacred process that helps to make science our most objective truth teller. But we know that the system of peer review is biased, unjust, unaccountable, incomplete, easily fixed, often insulting, usually ignorant, occasionally foolish, and frequently wrong. In addition to the paragraph highlighted above, I would like to draw your attention to a couple of other very worrying statements.
Allegations of research misconduct are best investigated by the institution where the original research took place. But that principle does not apply for some organisations, such as scientific or medical journals. With no independent tribunal to consider allegations of research or publication malpractice, a damaging dispute has been allowed to continue unresolved for 2 years, causing measurable harm to public health.
The debate about statins, as for MMR, has important implications for journals. Some research papers are more high risk to public health than others. Those papers deserve extra vigilance. They should be subjected to rigorous and extensive challenge during peer review. The risk of publication should be explicitly discussed and evaluated. If publication is agreed, it should be managed with exquisite care.
Authors and editors should be aligned on the messages they wish to convey, and every eff ort must be made to avoid misinterpretations and misunderstandings in the media. Editors also have to separate their roles as gatekeepers and campaigners. It is tempting to publish science that confirms pre- existing beliefs, especially if those beliefs underpin a campaign. Two ongoing campaigns.
As the Review we publish makes clear, the best available evidence indicates that neither statement is true. Would this be the same Richard Horton, editor of the Journal, the Lancet, ? Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.