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More MS news articles for June 2003

Shared scheme for assessing drugs for multiple sclerosis

Why are eyes tightly shut to considering causes other than autoimmunity?

http://bmj.com/cgi/content/full/326/7400/1213

BMJ  2003;326:1213 (31 May)
Abhijit Chaudhuri, Peter O Behan
University of Glasgow Department of Neurology, Institute of Neurological Sciences, South Glasgow University Hospitals NHS Trust, Glasgow G51 4TF

Letter to Editor

We agree with Sudlow and Counsell that the evidence for the risk sharing scheme for interferon beta and glatiramer in multiple sclerosis is poor.1 There are serious clinical and scientific flaws in advocating immunological treatments for multiple sclerosis.2 Before committing precious resources to any trial involving several thousand patients as proposed1 we have to be clear about the primary end point. In our view, it can only be the prevention of long term disability rather than reduction of short term fluctuations related to relapses.
Progressive neurological disability in multiple sclerosis is due to neuronal loss. Widespread axonal damage is always present even at the earliest clinical stages of the disease and is independent of the inflammatory changes.3 Multiple sclerosis is not an autoimmune disease and experience has shown that azathioprine is not effective. Investing in a long term randomised trial of "interferon beta or glatiramer versus azathioprine versus no treatment" will be as wasteful as the current risk sharing scheme.1 This is for several reasons, not the least being the characteristic side effect profiles of the individual treatments that will limit effective double blinding, a fact recognised in the Cochrane review of the interferon beta trials.

Future treatment trials should be based on metabolic strategy and neuroprotection.2 3 Rather than looking for small effects in a large trial, an alternative, which historically has proved more effective, will be to invest in small trials of many treatments looking for large effects.4 Why are we keeping our eyes so tightly shut in not looking for treatment for multiple sclerosis beyond autoimmunity?

AC is supported by the Barclay Research Trust in the University of Glasgow.

Competing interests:

None declared.

References

  1. Sudlow CLM, Counsell CE. Problems with the UK government's risk sharing scheme for assessing drugs for multiple sclerosis. BMJ 2003;326: 388-392. (15 February.)[Free Full Text]
  2. Behan PO, Chaudhuri A, Roep BO. Pathogenesis of multiple sclerosis revisited. J R Coll Phys Edinb 2002;32: 244-65.
  3. Fillipi M, Bozzali M, Rovaris M, Gonen O, Kesavadas C, Ghezzi A, et al. Evidence for widespread axonal damage at the earliest clinical stage of multiple sclerosis. Brain 2003;126: 433-7.[Abstract]
  4. Horrobin DF. Effective clinical innovation: an ethical imperative. Lancet 2002;359: 1857-8.[Medline]


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