On Friday the media aided and abetted an epidemic of misinformation by promoting a new review of statin data in The Lancet, without ascertaining crucial facts. To start with, it is not an independent review. As BMJ editor-in-chief Fiona Godlee said this is a review by the ‘trialists marking their own homework’ of the benefits of statins and rare side effects from industry sponsored studies. But the harsh reality is that the side effects are real and relatively common.
It’s high time the clinical trials units allow access to raw data
I have been a GP for over 30 years and have written tens of thousands of statin prescriptions in my career. I too started taking statins in my late 50s and I’m Asian, so I ticked various boxes for being at raised risk of heart disease. It seemed the sensible thing to do. Within two weeks, however, I started experiencing pains in my back and legs unlike anything I had suffered before. Mostly it was a dull ache, but for a couple of days a week the pain was crippling and I had to take painkillers. This went on for two years and I had to give up badminton, my favourite form of exercise.
Initially, I assumed the pain was something that would pass. In fact, it worsened, and the bouts became more frequent. I had problems sleeping and started to wonder about possible causes. I didn’t even consider statins. I was wondering instead about things like too much travelling or bad posture when sitting. I did various checks, like a liver function test, X-rays and an MRI scan, straining the NHS’s already overstretched resources. All came back clear. I even saw a neurologist and underwent nerve conduction studies after months of facial muscle fasciculations.
Finally, I thought it was worth seeing what would happen if I stopped taking the statins. Within two to three weeks my back and legs began to feel a lot better, my sleep improved and my muscle tremors disappeared. For me that was the litmus test that showed that the statin was the cause of the problem.
The Lancet review does not contain any substantially new information or data. Many of the studies used in the analysis had pre-randomisation run-in periods which means that people who complained of side-effects from statins were excluded from the trial. As pointed out by cardiologist and editor of JAMA Internal Medicine Rita Redberg 35% of statin users were excluded during the open-label run-in TNT trial. Thus, the actual adverse events rate is certainly higher than in the trials.
None of the Oxford Clinical Trials Unit data has been made available to other researchers despite multiple requests, all of these data are from industry sponsored studies, with concern for bias and no one has seen these data except the trialists. In addition, adverse events are under-reported in these trials, as they do not ask about the common ones and many use a definition of muscle problems which requires a creatine kinase (CPK) increase, yet many patients have muscle weakness without CPK increase.
Reliable real world data suggests up to 20% of statin users have muscle problems. The higher estimate certainly reflects the many patients I saw when I was practising, who are or were miserable when put on statins. It’s instructive to note that pharmaceutical company Pfizer’s (the manufacturer of atorvastatin) own patient leaflet states ‘common side-effects that may affect up to one in 10 patients include sore throat, nausea, digestive problems, muscle and joint pain.’
Earlier this year two groups of researchers in Japan and France have independently questioned the reliability of many of the earlier industry sponsored studies that show the benefit of statins. Japanese researcher even suggests that statins may be a cause of the increasing population burden of heart failure and reputed French cardiologist Dr Michel De Lorgeril’s own analysis reveals that all studies published after 2006 reveal ‘no benefit’ of statins for cardiovascular prevention in all groups of patients. But De Lorgeril goes further, and calls for a full reassessment of all the statin studies. He states ‘physicians should be aware that the present claims about the efficacy and safety of statins is not evidence-based.’
It’s high time the clinical trials units allows access to raw data. This is the only way to reassure doctors and patients on the true benefits and side effects that interfere with quality of life.
Dr Kailash Chand OBE is a retired GP and former deputy chair of BMA council. You can follow him on Twitter @kailashchandobe