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With advances in available therapy failure to act when RRMS patients have active disease could be considered negligent
For: Robert Brenner
Against: Gavin Giovannoni
Gavin Giovannoni has provided consultation to Bayer-Schering Healthcare, Biogen-Idec, Genzyme, GlaxoSmithKline, Merck-Serono, Novartis, Protein Discovery Laboratories, Teva-Aventis, UCB Pharma, Ironwood, Eisai, Vertex, Roche, Synthon and Canbex. He has received grant support from Bayer-Schering Healthcare, Biogen-Idec, Merck-Serono, Merz, Novartis, Teva-Aventis, GW Pharma.
Disclosures
With advances in available therapy failure to act when RRMS patients have active disease could be considered negligent.
The Middlesex Hospital before it was sold.
The Middlesex Hospital now; vacant and derelict.
Our mentor; Dr Gerald Stern.
Medicolegal work; in particular malpractice work.
38yr old teacher with RRMS under the care of Dr B at a London Hospital
• Glatiramer acetate 3 years (good adherence)
• Relapse with a mild left sensory loss
• Referred to me for a second opinion
• Switched to interferon-beta (IM IFNbeta-1a; www.msdecisions.org.uk)
• Mild persistent flu-like side effects and lymphopenia
• 12/12 NAb screen negative
• Volunteers for new research programme, which included an MRI protocol
Teacher
DISCLAIMER: This is a fictitious case to illustrate a
medico-legal point
Teacher
38yr old teacher with RRMS
• Forced to retire due to cognitive impairment and severe fatigue
• Developed depression and anxiety
• In her spare time she becomes and expert patient
– Widely read
– Net savvy; regular follower of www.ms-res.org
DISCLAIMER: This is a fictitious case to illustrate a
medico-legal point
Unemployment
Pfleger et al. Multiple Sclerosis 2010; 16(1) 121–126. 13
Costs and quality of life of patients with MS in Europe
Kobelt et al. J Neurol Neurosurg Psychiatry 2006;77:918–926.
Bermel et al. Ann Neuol 2012.
Predictors of long-term outcome in MSers treated with interferon beta-a
Bermel et al. Ann Neuol 2012.
Predictors of long-term outcome in MSers treated with interferon beta-1a
MRI to monitor treatment response to IFNβ: a meta-analysis
Dobson et al. Submitted 2013.
Study or Subgroup Odds Ratio
IV, Random, 95% CI
Kinkel 2008
Prosperini 2009
Total (95% CI) 9.86 (2.33, 41.70)
Study or Subgroup Odds Ratio
IV, Random, 95% CI
Kinkel 2008
Pozzilli 2005
Prosperini 2009
Sormani 2011
Total (95% CI) 2.69 (0.72, 10.04)
0.01 0.1 1 10 100 Disease Less Likely Disease More Likely
One New T2 Lesion
Favors Experimental Favors Control
100 10 1 0.1 0.01
Two or More New T2 Lesions
Study or Subgroup Odds Ratio
IV, Random, 95% CI
Kinkel 2008
Rio 2008
Total (95% CI) 5.46 (2.48, 12.04)
MRI to monitor treatment response to IFNβ: a meta-analysis
Dobson et al. Submitted 2013.
Study or Subgroup Odds Ratio
IV, Random, 95% CI
Kinkel 2008
Pozzilli 2005
Tomassini 2006
Total (95% CI) 3.34 (1.36, 8.22)
0.01 0.1 1 10 100 Disease Less Likely Disease More Likely
One New Gd+ Lesion
0.01 0.1 1 10 100
Disease Less Likely Disease More Likely
Two or More New Gd+ Lesions
DISCLAIMER: This is a fictitious case to illustrate a medico-legal point
Guidelines for the prescribing of IFN-beta and GA
Fulfil the following 4 criteria:
1. Able to walk independently
2. At least two clinically significant relapses in the last two years
Where possible, the patient’s history of relapses should have been confirmed by neurological examination or from another source e.g. hospital or general practitioner’s records, or by discussion with the patient’s main carer.
3. Adult age group (18 years or older)
no recommendations are possible in the paediatric age group, since trials have not been performed in this cohort.
4. There are no contraindications
Association of British Neurologists Guidelines for the use of Beta Interferons and Glatiramer Acetate in MS, January 2001.
Guidelines for the prescribing of Natalizumab
Natalizumab is recommended as an option for the treatment only of rapidly evolving severe relapsing–remitting multiple sclerosis (RES). RES is defined by two or more disabling relapses in 1 year,
and one or more gadolinium-enhancing lesions on brain magnetic
resonance imaging (MRI) or a significant increase in T2 lesion load
compared with a previous MRI.
1st-line or naïve MSers or 2nd-line (IFN-beta or GA failures)
NICE - Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis; August 2007.
Guidelines for the prescribing of Fingolimod
Fingolimod is recommended as an option for the treatment of highly active relapsing–remitting multiple sclerosis in adults, only if:
1. they have an unchanged or increased relapse rate or on-going severe relapses compared with the previous year despite treatment with beta interferon, and
2. the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme.
NICE Fingolimod: final appraisal determination document; 16 March 2012 .
The relapsing MS DMT doughnut
Inactive RRMS
CIS
RIS or asymptomatic MS
Suboptimal responders ?
Active RRMS
IFNbeta or GA
IFNbeta
Highly active RRMS Fingolimod Natalizumab
Verdict: not negligent
Teacher
Dr B
DISCLAIMER: This is a fictitious case to illustrate a
medico-legal point
Teacher
Dr B
Choice of natalizumab or fingolimod on a private prescription
DISCLAIMER: This is a fictitious case to illustrate a
medico-legal point
With advances in available therapy failure to act when RRMS patients have active disease could be considered negligent.
Neurologist
Wife
What would you do if this was your wife
or husband?
Would you risk the wrath of the NICE
inspectors?
DISCLAIMER: This is a fictitious case to illustrate a
medico-legal point