As patients will be asking questions of their allergists about Aimmune and "Standardized OIT" versus "Customized OIT" available now from 65+ board-certified allergists as part of their practices, I have put together some questions for them to use to discuss OIT.
ABOUT THE PRODUCT:
-What is "characterized" peanut flour?
-Why is "pharmacuetical grade" peanut flour better than FDA-approved "food grade" that we eat?
-Exactly which ingredients were added to the peanut flour to make this product? Could my child be allergic to any of them? Which diluents, glidants, lubricants and filling agents are added? Do any of them have long-term safety data?
-Why did they choose only measure a few proteins that cause anaphylaxis? (Arah h1, h2 & h6 and ignoring Arah h3, h8 & h9?)
-Did they directly test this product versus regular peanut flour used in OIT now to know that it is better? What were the results?
-Could you just use the same 12% defatted peanut flour milled from lightly roasted peanuts from the Golden State Peanut Co (Alpharetta, GA) and a compounding pharmacist to accurately measure it into capsules? Would the cost be less than $5500 per year?
ABOUT THE PROTOCOL:
-How does this protocol differ from Dr. Burk's studies at Duke conducted from 2007-2009?
-This uses one of 2 commonly used "Customized OIT" protocols. How many protocols did they test against each other to determine this protocol was the "best" one? What were the results?
-This "Standardized OIT" protocol reaches specific benchmarks much faster than the 2 commonly used "Customized OIT" protocols. Shouldn't a protocol "standardized for everyone" go SLOWER and not FASTER?
-What special medical training have you undergone to be able to perform OIT safely? Who provided this training?
-Will you be accessible to me 24/7? Cell phone, home phone?
SAFETY:
-Why is the starting dose of 0.5 mg 250 TIMES HIGHER than the current 65 board-certified allergists use now in OIT?
-Are patients ever not able to tolerate the first dose of 0.5mg? Would it be safer to start in micrograms? How would you adapt this product to start at a lower dose?
-Is it true that in the Phase 3 study, if patients cannot tolerate a minimum of 3 mg in a food on Day 1 they are dismissed from the study? So their study results will not be able to be extrapolated to the general public? They will not have data on safety or effectiveness on anyone who could not reach 3 mg?
-Stopping at 6 mg on Day 1, have patients ever tolerated it in office and then had problems at home with vomiting and stomach pain as a result? Could we stop at 3mg on Day 1 like many of the OIT doctors advise?
-If we have a problem updosing, can you adapt this product to create interim doses or do we have to stick to this exact protocol of largely doubling doses and using pre-measured and packaged doses?
FREEDOM & ENDPOINTS
-With this OIT product it says we still have to be on strict avoidance? Does that mean the same as now, or can we eat "may contains", Asian food, bakery product as long as there is no actual peanut? How much freedom do we get?
-Why is it better to stop at 300 mg with this product versus going higher and being fully desensitized and able to eat anything?
-Are there any differences with this versus regular OIT and getting the benefit of epigentic/DNA changes they are seeing at levels of 8-12 peanuts daily? Is there research to show we will still get all the benefits Stanford is reporting? Because they have patients on much higher doses.
RESULTS
-How does this product address/solve all the issues raised by leading allergists over the last 9 years? It seems to just standardize the dosing, which has never been raised as an issue.
(Cost, long term effects, EoE, home dosing, risk of anaphylaxis, false sense of safety
http://www.jaci-inpractice.org/article/S2213-2198(13)00457-1/fulltext )
FARE'S ROLE
-FARE founded Aimmune and is a major investor....and is now promoting Aimmune, a product they will directly financially profit from. Is this a conflict of interest that they are going to profit from this?
-Is it possible that FARE could be biased in favor of this product over using real food or the Viaskin patch?
-Is FARE going to release data showing that this "standardized" product they have created has measurable benefit for it's $5500 per year price tag versus the $50 annual cost for Planter's peanuts?
-How will FARE help Aimmune market this to the 70% of allergists they say will adopt their product once FDA-approved?