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Controversies in rheumatology

New generations of drugs and poorly recognised research are fuelling

fresh debates, writes

Dr Andrei Calin

heumatology is awash with controversies: some are a matter of scientific and academic debate, others are societal in nature. Among the latter is the extraordinarily difficult decision of whether physicians should champion the rights of our patients over those of the wider society.

Cost-benefits of biologic drugs

Take biologic drugs: etanercept, infliximab and the soon-to-be-launched adalumimab. These are relatively safe agents, fairly simple to take, and are more efficacious than anything that has come before. We could give anti-TNF to a young patient with rheumatoid disease expecting them to have less pain, stiffness, destruction and a better outcome, with improved function.

There will usually be every reason to prescribe such a drug ­ were it not for cost. Society will have to pay £12,000-£15,000 a year in direct drug costs plus the expense of administering the drug, which varies depending on whether it is given subcutaneously (etanercept and adalumimab) or intravenously (infliximab). Society has every right to ask whether treatment with methotrexate or other agents that cost little more than pennies per week is adequate.

None of us would question such reality, but we know many thousands of patients who failed to see adequate improvement with methotrexate and who would surely benefit from a biologic.

PCTs make this 'decision', but finance in the socialised NHS is not seamless. We all have different budgets. GPs are told to keep within their drug budgets, regardless that a patient treated with a biologic may well remain in work until normal retirement age and repay society many times over.

This 'saving' is invisible ­ at least in terms of drug budget management.

Anti-TNF agents are dramatically effective in ankylosing spondylitis and some other spondylarthritides, where no other disease-modifying agent exists. Ankylosing spondylitis fails to respond to gold, penicillamine, azathioprine, methotrexate, hydroxychloroquine, sulfasalazine or any other drugs in a meaningful way.

By contrast, infliximab and etanercept can improve patients' disease activity from around six or seven on a 0 to 10 scale (using the Bath Ankylosing Spondylitis Disease Activity Index) to around two or three (where 0 = excellent; 10 = disaster).

Similar improvement is found with global status and function, using the Bath Ankylosing Spondylitis Global Status and Functional Indices.

At Bath we follow some 6,500 patients with ankylosing spondylitis, referred from across the country. Around 40 per cent have BAS indices over four and would clearly benefit in a striking way from the new biologics. This would bankrupt drug budgets, but somehow, somewhere, society has to decide whether the individual or society comes first.

People currently making these decisions (those controlling Government purse-strings) have a poor understanding of cost-benefit analysis.

NSAIDs versus cox-2 inhibitors

Conventional NSAIDs versus cox-2 inhibitors is another controversy that dogs rheumatology. Cox-2 inhibitors are perhaps twice as expensive, but virtually every study confirms that by taking these (rofecoxib, celecoxib, etoricoxib and others) half as many patients suffer a massive GI bleed, perforate their bowel, require emergency transport to hospital, are admitted and half as much blood will be transfused.

Given some 2,500-3,000 patients die each year from using conventional NSAIDs, twice as many lives could be saved. We anticipate the death rate to reduce to perhaps 1,000-1,500 per annum. Again, excess overspending of NHS drug budgets is not offset against the money lost when we dial 999 for an emergency ambulance, get assessed, admitted and given emergency surgery. Not to mention all the other expense generated in a hospital setting.

Other areas in rheumatology are perhaps less controversial because the situation is more complicated. How much money do we spend when we admit a patient with, for example, rheumatoid disease to a multi-disciplinary unit where they can be assessed and managed by doctors, nurses, physiotherapists and even hydrotherapists? How much benefit does this translate into? To what extent should we be providing this service for our patients? Is it wiser to manage all our patients on an outpatient basis, simply admitting emergencies as they arise?

Benefits and side-effects

of corticosteroids

Corticosteroids have always presented rheumatologists with a dilemma. Undoubtedly this class of drug is a good anti-inflammatory agent. Patients and doctors frequently ignore the degree of toxicity.

For many years it was considered entirely inappropriate to give anything but occasional intra-articular steroid injections to a patient with rheumatoid disease, but some years ago a study suggested low-dose prednisolone may be beneficial in terms of decreasing the rate of progression of rheumatoid disease.

Nevertheless, there is perhaps, once more, a consensus that only in the most unusual case should steroids be given. For many patients the osteoporosis, hypertension, diabetes and other side-effects outweighed any minor improvement achieved with the steroid.

Early recognition of osteoporosis

Certain areas in rheumatology are uncontroversial from an academic point of view, but become so when considered against the availability of medical services. All of us should be assessed for osteoporosis, particularly when we have a chronic rheumatic complaint. Ready access to a DEXA scanner would allow early assessment of bone status, and appropriate remedial therapy, as indicated. However, for so many patients access to DEXA scanning is difficult and valuable time is lost, during which progressive osteoporosis occurs.

Ideally more funds would be available with osteoporosis assessment units even in smaller cities, allowing early diagnosis.

In ankylosing spondylitis, perhaps no fewer than 15 per cent of our patients have osteoporosis, but the difficulty lies in recognising which individual is at risk. Again, ideally, all patients with ankylosing spondylitis would be assessed for osteoporosis, and treatment given as indicated.

Ankylosing spondylitis

and hip replacement

Other aspects of rheumatology are controversial simply because the literature is not adequately recognised. We still see patients with ankylosing spondylitis who are advised by orthopaedic surgeons that they are 'too young' to receive a total hip replacement.

This still happens regardless of data that clearly shows that, even when hips are given to individuals in their 20s and 30s, long-term survival of the artificial joint is outstandingly good, with success rates in our population reaching more than 70 per cent for 10-year survival and even more than 60 per cent for 20-year survival.

Further, revision of total hip arthroplasty and even re-revisions survive surprisingly well and early access to total hip replacement should be considered mandatory.

Fibromyalgia ­ fact or fiction?

Relatively newly defined conditions such as fibromyalgia will inevitably remain controversial for years. Some rheumatologists refuse to recognise the condition. Some diagnose it freely, assuming it has some underlying biochemical or neuro-endocrine effect that needs to be taken seriously from the point of view of molecular science. Others believe fibromyalgia to be no more than an expression of unhappiness that requires little more than a diagnostic label and reassurance that things should improve over time.

Inevitably this controversy spills over into the medicolegal arena where some patients claim (readily supported by some lawyers) that their fibromyalgia was 'caused' by an unhappy event such as a minor road traffic accident.

Rather than receiving compensation for a bent mudguard, the patient claims a million pounds or so for fatigue and generalised aching.

Thus, fibromyalgia can present not only with discomfort, but also with an excuse to seek claims for many hundreds of thousands of pounds.

Without controversies, rheumatology would be a less exciting area, but it seems that every time we get rid ourselves of one a new one appears in its place.

Controversies in rheumatology

Around 3,000 people die each year from NSAID use ­ this could be halved by using more cox-2 inhibitors~

Controversies in rheumatology

clinical

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