Rheumatology Advance Access originally published online on November 28, 2006
Rheumatology 2007 46(2):370; doi:10.1093/rheumatology/kel385
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To Do No Good
Freeman Hospital, Newcastle NE7 7DN, 1University of Liverpool, University Hospital Aintree, Longmoor Lane, Liverpool L9 7AL, UK
Correspondence to: Dr D. J. Walker. E-mail: david.walker{at}nuth.nhs.uk
Mrs F.W., a 57-year-old nursing home manager, presented with a polyarthritis and plantar fasciitis in association with psoriasis in 2003. She was already taking meloxicam and co-proxamol. Her ESR was 51 and rheumatoid factor was 80. She was labelled as suffering from psoriatic arthritis. Because of indigestion she was changed to celecoxib, which was ineffective and then valdecoxib (even though it was not specifically licensed for psoriatic arthritis), which she found both tolerable and highly effective. She also continued on the co-proxamol, which she liked.
In January 2005, her GP was unwilling to prescribe co-proxamol following the CSM announcement that it was to be withdrawn. She assures us that she was not consulted by the CSM and therefore regards this as unilateral. She was then tried on co-codamol then tramadol and finally, simple paracetamol. None of these were as effective as the co-proxamol for her. She complained of more pain and was angry that she was refused the co-proxamol. She is told that there is no evidence from studies using aggregated data from large populations that co-proxamol is more effective than other analgesics. She replies that it certainly works better for her and that she was not included in any of the studies. ‘Does the only evidence that applies directly to me not count?’
Worse was to come in April, when valdecoxib was voluntarily (and unilaterally) suspended. She has since been changed to Sulindac, which is not as effective and which she cannot take continuously because of indigestion. ‘But I am not one of the two people in the UK who got Stevens Johnson from this and as I had been on it for 9 months I understand that my risk was even smaller’.
So, as we sit opposite Mrs F.W. (or any of hundreds of similar patients) in our clinic, we are thinking:
- I wonder how many doctors were in the MSD board-room when they decided to withdraw Vioxx? Perhaps there were a few accountants and lawyers who were making a commercial decision on behalf of their shareholders and they interpreted the scientific evidence in the context of the shareholders’ interest. Maybe they got it wrong!
- If the evidence is so precise, why have the FDA and the EMEA come to such different conclusions about the CV risks of coxibs and traditional NSAIDs?
- How could studies of the wrong dose of the drug in the wrong disease have caused so much trouble for this lady? Imagine the criticism if we were allowed to extrapolate wildly like that in treating patients in other circumstances!
- Is the Drug and Therapeutics Bulletin always right?
- Should not the benefit/risk ratio for drugs be considered on an individual basis, together with the patient, and in the light of relevant evidence, rather than the paternalistic (and scientifically grossly flawed) way that we are now being asked to adopt without question?
- If you just look at the published data without the context of real people who take drugs as they see fit, rather than as per protocol, then you can end up writing a daft editorial on management and conclude that ‘therapeutic touch’ is cost effective for OA [1].
- The current ranking of evidence does not take account of the size of the effect – so taping the patella or using a gel have better evidence than knee replacement!
We are most grateful to Binymin and Phillips [2] for engaging in the debate that we have wished to stimulate and providing us with the opportunity to publish this case report. Unfortunately their statement ‘Doubling the risk of myocardial infarction and stroke in order to control chronic dull ache and stiffness due to arthritis seems a logically unacceptable practice ...’ is so far away from our patients’ experience that we do not feel we have enough common ground to even have an argument. Twice very little is still very little!
Potential conflict of interests. The authors treat many patients with pain from arthritis. The authors have sat on advisory boards for the drug industry.
Conflict of interest: None of us like sitting opposite patients in pain when there have been better drugs made for them.
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- Shaughnessy AF. (2006) Gordon A.E. Life without cox 2 inhibitors. Br Med J 332:1287–8.
[Free Full Text] - Binymin KA and Phillips K. (2006) Rheumatol.[CrossRef][Web of Science][Medline]
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