9-month Infant Dies within three week on vigabatrin treatment
In doing my on-going due diligence on Questcor and Acthar, I came across this recently published (September 2009) article abstract in the Journal of Child Neurology that describes the death of a 9-month attributed directly to use of vigabatrin and related while spots in the brain. Does anyone have access to the full article that they can share?
Title: Pathological Evidence of Vacuolar Myelinopathy in a Child Following Vigabatrin Administration Myles Horton, MD1, Mubeen Rafay, MD, FRCPC2, and Marc R. Del Bigio, MD, PhD, FRCPC3
Partial Abstact: Vigabatrin, a -aminobutyric acid (GABA) aminotransferase–inhibiting drug used for seizure control, has been associated with white matter vacuolation and intramyelinic edema in animal studies. Similar pathological lesions have never been described in the central nervous system of human participants treated with the drug. Described here is a child with quadriparetic cerebral palsy secondary to hypoxic-ischemic brain injury following premature birth, who received vigabatrin for the treatment of infantile spasms at 9 months of age. A severe deterioration of neurologic function immediately followed the initiation of vigabatrin, and the child died 3 weeks later.
"are you just comparing the retail cost of the drugs - which probably nobody pays?"
I am not sure what you mean by "retail", the costs are what they are. Agreed that the insurance co-pay may be equal but when dealing with medically fragile children and insurance caps it does become important. In my opinion that point of view is what is contributing to the "health care crisis", even if the copay was the same it doesn't mean the total cost is the same.
2) what are the other medical costs involved - ie doctors and other tests for using V? it should be factored?
If you were to factor these I think you would find it would favor Vigabtrin, the majority of kids that start Acthar are admitted to the hospital, weekly blood test and blood pressure tests are required, some use home health care to administer the daily injections.
3) most importantly, what difference is the cost if V doesn't work?
I am not sure I understand your argument, what is the cost if Acthar doesn't work? If you have data that shows children treated with Acthar have a better long term prognosis that those treated with Vigabatrin, or any other treatment please share as I don't think that data exists. It is not like comparing rice to steak or fish, the vast majority of people would probably agree that rice is inferior to steak or fish. Success rates between Vigabatrin and Acthar are similar. In your example you are comparing apples to oranges.