Join me in the fight for better MS treatment!

The Expanded Disability Status Scale (EDSS) has been used in MS research
for decades, but it is inferior to modern composite measures such as the
MS functional composite (MSFC).  Because the FDA and EMA often require
EDSS as an outcome in clinical trials, it is difficult for pharmaceutical

companies to test new innovative drugs.  This is a particular problem for
older people with progressive MS.  Many of my patients face the reality of
no proven treatment options, and they cannot even get into clinical trials
because they do not meet the age and disability inclusion criteria.

Here are 10 specific criticisms of the EDSS:

1)      The score is unreliable with tremendous interrater variability.  One
study found that for people with low EDSS (EDSS scores of 1.0 to 3.5),
scores between two examiners often vary by 1.5.  Source: 
https://pubmed.ncbi.nlm.nih.gov/1565242/
2)    At lower scores, the score fluctuates tremendously. 
3)    At higher scores, the score stagnates.  This is a big problem for
research.  How do you prove your drug is better than placebo if the EDSS
doesn't change?
4)    It’s not an additive scale, and some disabilities trump others.  A
person with MS who walks with a cane but has no other problems and
works full time could score 6.0.  Meanwhile, another person with MS
could walk with a cane, be legally blind, have advanced dementia, and
numerous other disabilities and still score 6.0
5)    Cognitive function is not well represented
6)    EDSS is very strongly driven by lower extremity function.  There is
more to MS than its affect on the legs.
7)    It’s very non-linear (The difference between EDSS 2.0 and 2.5 is small,
but the difference between 6.0 and 6.5 is huge)
8)      Sometimes, it’s a game of telephone.  EDSS scores of 4.5-6.0 are
influenced by walking distance, but the examiner will not actually observe

the patient walk 300 meters.  What is the point of an "objective" scale if
the examiner is just going to ask the patient how far they can walk?
9)      Some items on the EDSS are neurologic signs but do not reflect
actual disability (reflexes, Babinski sign, etc).  These assessments are
pointless.
10)   It’s difficult to perform the EDSS.  Only a physician, physician's assistant, nurse practitioner, or someone with significant experience
performing a neurological exam can assess it reliably.  By contrast, a high
school student could likely be trained to assess the MSFC accurately. 
Using the EDSS makes is more difficult and expensive to run clinical trials.
 
This petition calls for regulatory bodies such as the FDA and EMA to
accept composite outcomes of disablity for MS clinical trials.  We believe
this change will result in the following benefits:
 
1) A higher probability of developing new beneficial treatments for
progressive MS
2) More access to clinical trials for older people with MS, those with
progressive disease, and those with significant mobility problems.
3) Reduced cost of clinical trials
4) More opportunities to study non-pharmaceutical interventions such as
nutrition, vitamin supplementation, exercise, and mindfulness
5) Better clinical trial data so we can clearly weigh the potential risks and
benefits of a treatment.

 
This petition will be sent to regulatory representatives with the hope of
enacting immediate meaningful change.  Please share it with anyone
affected by MS or who with those who care about them.
 
-Brandon Beaber (multiple sclerosis neurologist in Los Angeles, CA, USA)

Quality accessible MS research.

Although the EDSS had a historical role, everyone in the field knows
composite outcomes are better.  For how long will we continue to use an
inferior disability scale?  The time for change is now.