Its hard to believe I am approaching my sixteenth 'anniversary' since formally engaging the ALS 'battle.' I was indirectly involved years before because the research area where I work can help many individuals, including those with ALS. According to the rules, six to seven years are required to validate a new molecule for treatment in a particular disease but numerous "Big Pharma" types have publically advised aspiring scientists they will need at least ten to fifteen years: if they are lucky. At present, as the DiPALS study evidences, the pacer is not yet ready for a Phase III study but how far away are we? Thankfully patients may obtain the pacer via the HUD/HDE but what about the guidance physicians and patients need on perfecting the timing or elucidating the therapeutic value seen in the report of Dr. Onders in last year's American Journal of Surgery? Bad medicine can save time but good medicine can save lives! The question whether there is a case against the pacer is of course an important one; I often review the cases I have discovered to appraise whether the weakest cases can be selected, and construed as a pilot study - are there inferences validly drawn therefrom working against the treatment? The ordinary media can make the task more difficult by failing to be careful in its choice of words. We still need to work on the question of 'it seems to work in many cases but why?'

Indeed, why do people get ALS to begin with?

At present, I am not sure whether those who would pursue a case against the pacer deserve 'a turn at bat' and I will develop this thought later but I wanted to point out the significance of Dr. Onder's paper as a showing of a de-facto biomarker, or even better than a biomarker. The ability to read the diaphragm's EMG signals live and continuously for long periods of time ought to make efficacy studies less expensive and faster to achieve preliminary insight as to prospective molecule's value. Patients may find they could enter studies based on the extent of the involvement of their diaphragm muscles and whether they are using the pacer as satisfying entry criteria . . . such can be a little better than the 'recently 'diagnosed'' standard; I shall also try to explain why such ought to be so.