By Jerome Burne
If you aren’t confused about what is going on with statins then you haven’t been paying attention. As an example of just how convoluted it’s getting, take the email forwarded to me last week that had gone to members of the British Cardiovascular Society (BCS) asking them to fill in a short survey about any patients who had stopped taking statins.
How boring, right? So what? In fact it’s part of an increasingly vicious battle over the rights and wrongs of statins and shows that the gloves have not just come off but that knuckle dusters are being slipped on.
If you really haven’t been paying attention, the story so far has been covered in a number of previous HIUK posts. How ardent statinator Professor Sir Rory Collins challenged the BMJ to withdraw papers critical of his position, essentially that the drugs benefit pretty well everyone and are virtually side-effect free.
Transparency would be a good idea
How a committee set up to investigate concluded the papers could remain but suggested that much more transparency from Sir Rory about the trial data his organisation holds would be a good idea. As part of this very public academic clash, Sir Rory was quoted in the press as saying that raising doubts about statin benefits would stop people taking the drugs and so lose their heart protection.
He claimed it could cost even more lives than the scare over the MMR vaccine. Strong stuff and wonderfully revealing of the bare knuckle reality behind the calm rationality supposedly supporting evidence based medicine.
In light of Sir Rory’s public statements this apparently innocuous, run-of-the-mill academic survey looks a lot more interesting. Not least because it seemed to me to have nothing to do with real research; instead it looks more like a poll conducted by the Tory party designed to scupper a Labour policy.
My own totally unscientific poll
It seems highly likely that its purpose is to provide hard data to support Sir Rory’s allegation that his critics are putting people’s lives at risk. And that the results will be soon be put out in a press release claiming that if you scale up the results it shows that X thousand people in the UK could be dying early as a result of the dangerous claims of the statin critics. The BCS has said that Sir Rory was not involved in the survey although he knew about it.
To check I was in the right ball park I conducted my own totally unscientific poll by asking three cardiologists and a GP what they made of it.
They all agreed it wasn’t going to yield any useful scientific information and that its agenda seemed political. ‘Designed to gather information to hit critics,’ said one. ‘This looks like part of a smear campaign,’ commented another. Two commented that, given it didn’t count as research, they’d like to know who had funded it.
The reasons they gave for its lack of science were also interesting. One pointed out that given the relatively small sample size it would need a response rate of at least 80% – rare in such questionnaires – if it was going to provide any meaningful data at all.
The cardiologists pointed out that the bulk of their patients were people who had had a heart attack but that the articles mentioned in the survey were concerned with healthy people taking statins for prevention. ‘Even if I do see one of these people I rarely see them again unless they show up with a heart attack,’ said one, ‘so anything I said about their statin use would be purely guess work.’
We all have a right not to take drugs
Another made a wider point which I think is the most serious criticism of the whole venture. ‘The underlying assumption is that stopping is necessarily a bad thing. But people have all sorts of reasons for deciding to stop a drug – side effects, not wanting to take drugs for life or just deciding the small benefit is not worth the risk. Patients should have personal choice in deciding to take a drug and we should respect that.’
The attitude to patients revealed by the survey is not reassuring. It certainly isn’t going to provide any clarity and worse it smacks of an old-fashioned medical authoritarianism that I certainly hope will have no place in the way us ageing baby boomers are going to be treated.
So I’ve constructed my own small questionnaire for Sir Rory himself. However the answers might be rather more useful to the rest of us than what the BCS has come up with.
Q: Do you have any plans to set up an independent assessment of the commercial data on statins held by CTT as recommended by the BMJ committee?
Q: Do you plan to run any non-commercial trials to gather reliable data on statin side-effects.
Q: You provided the BMJ committee with a declaration of interests showing that the CTT had received over 200 million pounds from just one drug company to run trials. Will that be retrospectively added to declarations made as part of existing studies and be part of future CTT research?
Q: Do you plan to respond in a standard way to other researchers who have provided detailed critiques of your work.
Can we trust data from commercial trials?
My fingers had barely left the keyboard before it became clear that Sir Rory would answer all of my question with a ringing: No. A letter from him and others at the CTT has been published in the current issue of the Lancet that sets out a detailed criticism of the open letter to NICE, which adds another layer of complication to this saga. I’m certainly not qualified to comment on it in any detail, being a reporter rather than a biomedical statistician, but it is clear the Sir Rory is facing down his critics.
Much of the critique involves challenging the accuracy of the statistics about side effects quoted in the original letter. Essentially he claims that the true rate of side effects much lower than the letter claims. What is clear, however is that Sir Rory has chosen not to address the central concern of his critics that he is relying exclusively on side-effect data obtained from the large commercial trials.
The other major concern is that no independent researchers have been able to look at the commercial trials. He puts up a novel (to me at least) defence saying that the data was looked at by NICE and found to be reliable. However he makes no comment about the fact that a majority of members on the NICE committee involved in altering the guidelines had declared financial links to the drug companies.
He also rejects the worry that the large, and until very recently unacknowledged, funding of CTT by drug companies might affect its findings. The money was to run trials, he says, but the analysis of those trials is done independently by CTT members and is funded by the government and charities. Since the whole issue of the funding of CTT is still very opaque that is unlikely to be the final word.
As I said, you have every reason to be confused. (For another account of the BCS survey of its members see: Dr Malcolm Kendrick’s blog.