Linking to another thread started here today:

why is a startup charging parents $180 for $2 worth peanut butter?

New webcast from Aimmune:

http://ir.aimmune.com/phoenix.zhtml?c=254097&p=irol-EventDetails&EventId=5230316

FARE Urges FDA to Help Meet the Unmet Need for Food Allergy Therapeutics
At the end of the article they toss in their little disclaimer:

* Note from FARE:   FARE provided seed funding for Aimmune, formerly known as Allergen Research Corporation (ARC), after convening its 2011 Research Retreat. The retreat brought together leading scientists from all over the world and helped to frame key challenges with advancing oral immunotherapy through the FDA approval process, including the lack of a standardized product that could be tested in clinical trials on a broad scale. ARC sought to solve those problems, and with seed funding from FARE and other investors was able to create a standardized peanut OIT product that is being tested in Phase III clinical trials.

As an initial investor, FARE continues to hold stock in Aimmune, but we do not have any involvement with the governance or day-to-day workings of the company. This information was disclosed to the FDA.

https://blog.foodallergy.org/2016/01/26/fare-urges-fda-to-help-meet-the-unmet-need-for-food-allergy-therapeutics/?tr=y&auid=16421601

"What is the incentive for these companies and others to develop therapies? In a recent Reuters article, analysts estimated that a year's supply of Viaskin will cost $6,500 and Aimmune's treatment will cost $5,500.  The article quotes Credit Suisse analyst Vamil Diwan estimating that AR101 could could reach peak annual US sales of $1.33 billion, while analysts at Morgan Stanley and Jefferies estimate Viaskin could reach potential for annual sales of greater than $2 billion."

http://snacksafely.com/2015/10/breakthrough-food-allergy-therapies-and-the-big-business-behind-them/

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?

The FARE statement says 50-70% of patients complete desensitization.  That is far lower than Aimmune claims with its claim of 80% and far lower than NEFATC, with its claim of over 90% success (after excluding people who have had the most serious of reactions - people who have been in the ICU, for example.)  The numbers do not make sense to me. 
I think they come from an early study where they were not having people take safety precautions now common at NEFATC and other places like having carbs with the dose, not exercising 2 hours after, not taking a hot bath or shower before and after, etc, etc.  So, the number looks falsely inflated to me.

There are no standard protocols but there are protocols that are used by a large number of the doctors who do offer OIT.  The doctors who collaborate with Dr. Nadeau practice very similarly if not the same way.  Their methods won't ever be abel to be approved by the FDA because they used unadulterated food, so mentioning this implies something that isn't the case--that the FDA doesn't think what they are doing is safe and so hasn't given its approval.  That's not why they didn't get FDA approval.

Also, the patients of many OIT clinics already do get covered by insurance, so mentioning that also sounds like it is put there intentionally to push people from considering OIT.

The statement says, 'The National Institute of Allergy and Infectious Diseases (NIAID) Guidelines for the Diagnosis and Management of Food Allergy in the United States does not recommend allergen immunotherapy to treat IgE-mediated food allergy. The expert panel that authored this document believes that additional safety and efficacy studies are needed.'

When was this written?  If these same people will accept Aimmune and recommend it that doesn't make much sense to me.  I may be missing something but I believe Dr. Nadeau is years ahead of Aimmune in terms of research and that she has proceeded in steps that would normally occur in the process to get FDA approval.  If FARE wants to argue no OIT is ready for prime time but that Aimmune will be once stage 3 is complete that sounds dubious to me given the over 10 years of research of Dr. Nadeau and associates. 

'Because of this, FARE helped launch Allergen Research Corporation (now Aimmune Therapeutics) to perform the large-scale studies required for FDA approval. In addition, multiple, small studies continue to show efficacy for new approaches to OIT, which is why FARE continues to support innovative OIT development in academic centers.'

Here they seem to be arguing the other way.  First OIT isn't safe.  Now it is. 

'An allergist doing OIT for patients in a private practice develops his/her own individualized protocols and uses his/her unique food preparation.

This can be true and there are some doing all sorts of things, some quite risky, I'm sure.  But there is a large number of doctors who are following the same process that Dr. Nadeau has researched, so I find this misleading.

'While many report success, the exact outcomes and complications cannot be fully assessed given the differences in the feeding protocol and in the food used in treatment.'

This statements is as if Dr. Nadeau's research doesn't even exit.  Her research is well-documented and Aimmune I'm sure uses info from her work as well.

'Therefore, while FARE supports those patients who might consider private practice OIT, we are not able to evaluate or compare any particular practice or physician.'

I don't think the addition of Aimmune will resolve these concerns.   Individual doctors will still be able to do things in all different ways, even if they use Aimmune. 

'Ultimately, the decision to enter private practice OIT is an individual one that should be reached after extensive consultation between a patient and his/her allergist including an assessment of the involved risk. We believe the discussions around starting OIT should occur in a manner akin to the informed consent procedures in a clinical trial setting.'

I wonder if they will still say this or if their tone will change once Aimmune has FDA approval.

I don't know if FARE is motivated by potential profit.  I don't want to believe that is the case. 

Feb. 2016  FARE press room statement (making sureit is here):

http://www.foodallergy.org/press-room/fare-statements#.VwJtphIrIT

I do appreciate this (from above):

QuoteUltimately, the decision to enter private practice OIT is an individual one that should be reached after extensive consultation between a patient and his/her allergist including an assessment of the involved risk. We believe the discussions around starting OIT should occur in a manner akin to the informed consent procedures in a clinical trial setting.

Some doctors think that OIT doesn't cause EoE but that it shows it in people who already would have had it to the foods they just happened to be allergic to.  so, when they do OIT they eat those foods and seem to develop EoE but really, they had it all along but were asymptomatic due to having an IgE allergy to their EoE trigger food.  The top IgE foods and top EoE foods are the same in the USA so this seems possible to me.  Does OIT actually cause EoE?  I don't know.  I don't know how you could prove that easily without doing a gene assay test on everyone ahead of time to determine if they have it or not (which would require scope and biopsy) and then you could rule out people having EoE who test neg on the gene assay test and later develop symptoms.  Otherwise, I do'nt think we know know if OIT is *causing* it or if it is there and showing itself due to EoE trigger exposure.

Quote from: ajasfolks2 on April 03, 2016, 02:05:50 PM
Pondering . . . wonder if the proteins removed from Aimmune might be culprits in exacerbating or creating EoE and that is why there would be this change too?

The proteins are not removed from Aimmune's product.  They are all in there. 

Quote from: ajasfolks2 on April 03, 2016, 12:20:54 PM
And I would hope, down the road, that there would be studies as to OIT and comparison of straight-from-manufacturer peanut flour use vs. Aimmune's patented peanut flour based product.

Of course, this would take years and assume that OIT remains a viable treatment for desensitizing as to LTFA.

The jury is still out.

There should not be any difference based on whether someone uses peanut flour, peanuts, or Aimmune's pill.  Dosing schedule, whether they take proper precautions like having people eat carbs with their dose, avoid taking a hot shower or bath before and after the dose, and rest after the dose, etc will make a difference and how aggressively they updose, etc but not whether or not they use Aimmune.  Aimmune and OIT are the same thing, just that one is in a pill that is being sold and has a low end goal.

Just trying to put all we can in here for best balanced picture and means of assessing:

(Mid page there, click on Corporate Presentation March 2016 .pdf)

http://ir.aimmune.com/phoenix.zhtml?c=254097&p=irol-irhome

Pondering . . . wonder if the proteins removed from Aimmune might be culprits in exacerbating or creating EoE and that is why there would be this change too?

And I would hope, down the road, that there would be studies as to OIT and comparison of straight-from-manufacturer peanut flour use vs. Aimmune's patented peanut flour based product.

Of course, this would take years and assume that OIT remains a viable treatment for desensitizing as to LTFA.

The jury is still out.

As to new member gailf's post above and her assertions, I would need to read a whole lot more (other sources, certainly)  to decide for myself what the relationships are or ARE NOT . . . in order to draw on conclusions from all available information.

Just sayin'.

Oh my.

Thank you for connecting the dots