Analysis: Why in an age of health cuts we need more government research, Bureau of Investigative Journalism, 4 August 2011

From the Bureau of Investigative Journalism at the City University, London, 4 August 2011 (story by Iain Overton).

With unprecedented debt affecting many of the developed world’s economies, there is much concern about the impact of cost savings on healthcare. In the UK the NHS needs to save £20bn by 2015.

Where savings will come from is a source of deep contention.

But some reports have focused on the fact that the NHS is spending unacceptable amounts on the cost of some of its medicine. Latest annual figures show pharmaceuticals cost the NHS £11.9bn in primary and secondary care – almost 12% of total revenue. Cost-benefit analysis of treatment, though, is a tricky subject.

Multiple sclerosis
Multiple sclerosis (MS) is a good example. It is a very costly disease. The estimated cost to the UK economy of MS is over £1.4bn a year. Of this about 8% was spent on the cost of disease-modifying drugs.

Recently, however, the leading journal Neurology published a report comparing two groups of MS sufferers. One group was on treatment and the other was not. Not seeing a dramatic difference in the two groups, the authors concluded that many disease-modifying therapies (DMTs) in multiple sclerosis are far from cost-effective. Interferon β-1a, interferon β-1b, and glatiramer acetate were seen to deliver ‘modest health gains’ at best.

‘It is very unlikely that under current pricing and prescribing patterns, DMT may be considered cost-effective for patients with relapsing-remitting MS and secondary progressive MS,’ the authors concluded.

Some have challenged the methodology of this report, but it serves to highlight a major issue. That of the challenge of finding drugs that are both effective and in terms of costs, financially justifiable.

Drugs effectiveness
On a drugs effectiveness – if DMTs for MS were more effective then treatment should reduce the longer-term costs of disabled care by reducing disability progression.

A new raft of drugs are being developed to treat MS that might be more up to the job.

The immunomodulatory drug, Fingolimod, for instance, shows promise. A trial comparing its effectiveness with a placebo showed relapse rates reduced by as much as 60% and reduced disability progression by about 30% over six months. When compared to one of the older standard treatments of MS, beta-interferon-1a, it was shown to be better at reducing relapse rates by some 53%.

But in a little publicised note on the NHS Nice website, the committee who would sign off on Fingolimod, pushed back the deadline for its decision by almost a year. It cited ‘resource constraints and efficiency scheduling’. This seems to be code for ‘the drug is very expensive and we have to wait to see if we can afford it’.

Old Treatments, New Tricks
In a cash-strapped era, the far bigger question is this: can healthcare providers, particularly state ones, afford such expensive drugs?

Fingolimod is reported to cost up to $48,000 a year to patients in the US. It is likely to cost less in the UK, but still more than the current first-line DMTs offered by the NHS.

The thornier issue, then, is not the effectiveness of the drug, but rather the cost.

When faced with this reality, we have to acknowledge then that there are a number of generic, older treatments that might be as efficient in treating MS as the new wave of drugs, but at a much lower cost.

These are older remedies that could, in the case of MS, be used for new tricks. These treatments include vitamin D, Minocyline, Fumaric Acid Esters, Parasites, Lipoic Acid and Low Dose Naltrexone. They have all been shown to have some promise for MS. And being generic treatments they are not under patent from a drug company, so they are comparatively much cheaper.

But the trouble is this – there is no hard, categorical proof that any of these are as good or better than the standard treatment. It is a dilemma summed up in an editorial in Journal of Neuroimmunology writing on the use of parasites to treat Multiple Sclerosis:

What is required is rigorous, objective evaluation … at the levels of animal models, clinical trials, and immunology.

The trouble is that ‘rigorous, objective evaluation’ of treatments that cannot be licensed is costly – a Phase III trial can run into the millions of pounds. And this, of course, is not something that will be done by the drug companies.

Dr D. Craig Hooper of the Thomas Jefferson University in the United States, who has done much work in whether antioxidants have the potential to treat MS, is clear on the conundrum: ‘this is not something that big pharma is going to get into – governments have to do this sort of thing’.

Government needs to step up to do the work drug companies will not do.

Admittedly, something like this does exist. The Health Technology Assessment programme (HTA) produces independent research about the effectiveness of different healthcare treatments and commissions the research it thinks is most important through different funding routes.

But, despite not suffering the cuts that have befallen other public sectors, the HTA still has limited funding and does not always commission bold work. Recently, for instance, a Phase 3 trial of vitamin D for MS was considered by the HTA but was rejected, despite there being seemingly compelling evidence that low levels of Vitamin D is linked in those who develop MS.

Medics, also, have proven unwilling to pursue research like this. The HTA recently advertised for a trial of an off-patent drug – azathioprine – in MS. It had no applications.

The need for innovation
The seeming reticence to innovate and experiment in the NHS has been highlighted in other areas. Sir John Bell, who led an inquiry into the future of NHS genetics, has said: ‘There has already been a lot of innovation, almost none of which has been adopted by the NHS…There’s more than enough we could be doing here, but the NHS is completely unprepared’.

And in The Times’ letters pages there was a recent headline that ran: ‘Chronic Fatigue syndrome needs more research’.

There is both a moral and an economic argument for the NHS to prioritise and aggressively push research both in terms of funding and in terms of pushing clinicians into this field.

Moral in the sense that more government-sponsored trials could help find highly effective uses for older drugs for people afflicted by terrible diseases.

And economic in that the overall cost to patient and state for these old drugs performing new tricks would be considerably less than many existing low-functioning disease modifying treatments.

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