Scottish GP Dr Malcolm Kendrick starts off his post on the latest statins controversy with a great George Orwell quote: ‘If liberty means anything at all, it means the right to tell people what they do not want to hear.’ Kendrick is author of The Great Cholesterol Con. He is scathing about the latest research on statins published in The Lancet. Lead author is Sir Rory Collins, Professor of Medicine and Epidemiology at Oxford University’s Clinical Trial Service Unit.
Collins and co-authors claim their research is the definitive answer to controversy surrounding safety and efficacy of the blockbuster drugs. And not just for secondary prevention (to prevent a second heart attack or stroke). They say statins are effective for primary prevention as well – to prevent one from happening in the first place – even in otherwise healthy people. They say the debate is over because the evidence is overwhelming.
Should you swallow that whole? Probably not, and not just because this study is industry-funded as the extensive DOI (declaration of interests) at the end shows. Here’s what Kendrick has to say. It’s another riveting read. – Marika Sboros
Click here for a full link to Interpretation of the evidence for the efficacy and safety of statin therapy
By Dr Malcolm Kendrick
Many of you may be aware of an article published in the Lancet on the eighth of September. ‘Interpretation of the evidence for the efficacy and safety of statin therapy.’ It caused a media stir, and I was asked to appear on a few BBC programmes to argue against it – tricky in two minutes.
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 16, 2015, predicting exactly what was going to happen, who was going to be involved, and (in broad terms) exactly what they were going to say:
(Editor’s note: here follows a shortened version of Kendrick’s blog in 2015. For a full version, scroll down below.)
Some of you may have seen a headline in the Sunday Express newspaper: Statins expert calls for safety checks over the drug. The subheading was Oxford professor whose findings were central to the mass prescription of statins is to re-examine trial data after concerns over the heart drug
Those of you who read this blog probably know that the professor in question is Sir Rory Collins. 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.
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 18 – 20%.
He stated that these articles were irresponsible, worse than Andrew Wakefield’s work on the MMR vaccine. And that thousands would die if they were scared off taking their statins by such articles. Ah yes, the old ‘thousands will die’ game. 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 17.4% of people suffered adverse effects. So, yes, a pedant would say that the 18 – 20% figure was wrong – although not very wrong. Certainly not worth a demand for 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:
“As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that The BMJ retract two articles that were highly critical of statins. 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’s editor-in-chief, Fiona Godlee, to convene an outside panel of experts to review the problem.”
Click here to read: STATINS: MAD, BAD WORLD OF CHOLESTEROL DRUGS
The report of the independent statins review panel exonerates The BMJ from wrong doing and said the controversial articles should not be retracted:
“The panel were unanimous in their decision that the two papers do not meet any of the criteria for retraction. 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.”
In fact, the panel was critical of Collins for refusing to submit a published response to the articles:
“The panel noted with concern that despite the Editor’s repeated requests that Rory Collins should put his criticisms in writing as a rapid response, a letter to the editor or as a stand-alone article, all his submissions were clearly marked ‘Not for Publication’. The panel considered this unlikely to promote open scientific dialogue in the tradition of the BMJ.”
To provide a bit more context at this point, you should know that for a number of years, people have been trying to get Rory Collins to release the data he and his unit (the CTT), holds on statins. [The CTT was set up purely to get hold of and review all the data on statins, it has no other function].
He has stubbornly refused to let anyone see anything. 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 ‘confidential’ or ‘commercially sensitive’ now?
[The concept that vital data on drug adverse effects can be considered confidential, and no-one is allowed to see it, is completely ridiculous anyway. But that is an argument for another day.]
— Hants Hippy (@hants_hippy) September 9, 2016
Now, amazingly, after running the CTT for nearly 20 years, Collins claims that “he has not seen the full data on side-effects”. In an e-mail to the Sunday Express, he stated that his team had “assessed the effects of statins on heart disease and cancer but not other side effects such as muscle pain”.
Let that statement percolate for a moment or two. 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 – which surely must be the case if he hasn’t even seen it.
Give us a clue. 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 20%. This was an interesting stance to take, 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 the CTT may or may not hold.
- Click here for a full version of A humiliating climb down – or a Machiavellian move?
- This blog first appeared on Dr Malcolm Kendrick‘s website and is republished with permission.
- Lead image: By Dasemarcalvarez (Own work) [CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons