Quote from: gvmom on September 20, 2017, 10:52:18 AM
Will it be one of those cases where even if patients "win", we lose?

Yes.  Of course.  Naturally.

Naturally.   Yeah.   


I really don't want to be a cynical person ... but that's really hard these days.


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ETA



Re: American healthcare - patient-centered?

Quote from: LinksEtc on September 27, 2017, 07:04:13 AM
Obviously, I've collected a lot of negative examples in this thread ... mostly to encourage people to critically think about what is really in our (patients') best interest ... sometimes, if we don't look out for our needs, nobody else will ... we can get complacent if we blindly trust that others (docs, patient orgs, government, etc.) always have genuine concern for our well-being.

Yes, I'm feeling somewhat depressed and disheartened ...

at the same time, I still think that things have the potential to get better ...

whether talking about patients & healthcare ... or citizens and government ...

for instance, there are drugs that have been developed that save lives, there are docs who truly care, there are
patient orgs where patient needs are the primary focus, etc. ...

maybe we have to find that right balance between hope & critical thinking ...

-----------------------------------------------------------------


"Hope, Cynicism, and the Stories We Tell Ourselves"
By Maria Popova
https://www.brainpickings.org/2015/02/09/hope-cynicism/

QuoteCritical thinking without hope is cynicism. Hope without critical thinking is naïveté.

Finding fault and feeling hopeless about improving the situation produces resignation — cynicism is both resignation's symptom and a futile self-protection mechanism against it.

Will it be one of those cases where even if patients "win", we lose?

Yes.  Of course.  Naturally.  Unless there is more money and less regulation, implementation & enforcement, in anything that might be an actual win.

I probably should have asked if you were really being rhetorical......

.

"Report from the National Academies of Sciences, Engineering and Medicine: Recommendations to the Food Industry and Regulatory Agencies on the Management of Food Allergens"
By Steve L. Taylor, Ph.D., and Maria Oria, Ph.D.
February/March 2017

https://www.foodsafetymagazine.com/magazine-archive1/februarymarch-2017/report-from-the-national-academies-of-sciences-engineering-and-medicine-recommendations-to-the-food-industry-and-regulatory-agencies-on-the-management-of-food-allergens/

-----------------------------


"Critical Issues in Food Allergy: A National Academies Consensus Report"

Scott H. Sicherer, Katrina Allen, Gideon Lack, Steve L. Taylor, Sharon M. Donovan, Maria Oria

July 2017

http://pediatrics.aappublications.org/content/early/2017/07/19/peds.2017-0194

QuoteDr Taylor received grant support for research from the National Institute of Food and Agriculture and from the Food Allergy Research and Resource Program consortium of over 90 food manufacturers and/or suppliers as well as royalties from Neogen Corp.

Before I continue ... let me put this here:

"Are the National Academies Fair and Balanced?
One in Five Scientists on NAS Issue Panels Tied to Firms Involved in Issue"
July 24, 2006
https://cspinet.org/new/200607241.html

QuoteCSPI doesn't dispute the high quality of reports produced by the National Academies (which include the National Academy of Sciences, the Institute of Medicine, the National Academy of Engineering, and the National Research Council). But it says that the NAS should strengthen its policies for avoiding and disclosing conflicts of interest and for maintaining balance if the NAS is to maintain the credibility it currently enjoys.

It's something to think about.

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ok, back to that report ... I think this is the latest (final?) version ... 2017:


"Finding a Path to Safety in Food Allergy:
Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy (2017) "
https://www.nap.edu/catalog/23658/finding-a-path-to-safety-in-food-allergy-assessment-of

https://www.nap.edu/read/23658/chapter/1

Page 288:

QuoteInsufficient evidence exists on the prevalence and severity of allergies to other foods on the lists of priority allergenic foods in other countries, including molluscan shellfish, mustard, celery root, and buckwheat, to warrant their addition to the priority list in the United States.

Page 312:

Quotein the United States, some foods listed by the FDA as tree nuts (i.e., beech nut, butternut, chestnut, chinquapin, coconut, gingko nut, hickory nut, lichee nut, pili nut, shea nut) could be removed from the current priority list based on the paucity of data or low frequency of allergic reactions.

Coming from a patient/consumer background, I think that existing data and studies could have been used to make different policy recommendations.

For instance, I think that there may be enough data/evidence to make a good argument that mustard should be included in the USA priority list as it is for Canada:
https://www.canada.ca/en/health-canada/services/food-nutrition/reports-publications/food-safety/mustard-priority-food-allergen.html

Or ... for the addition of the category "Seeds":  sesame, mustard, sunflower, etc.

Some were arguing against the addition of sesame to the priority list before the CSPI petition was filed ... did the science change or the politics? 

When I was active in the food allergy community, I met several people dealing with coconut allergy ... I feel badly because that allergen is going to be a nightmare to avoid imo if it is again allowed to "hide" on the food label under terms like "natural flavor".  Many food products will probably become off-limits for the coconut-allergic if that allergen is removed from the priority list.  Coconut may not have a high prevalence, but do patient quality-of-life considerations count for nothing?

Like I said before, I'm no longer involved in food allergy advocacy ... it does not affect my family ... and if the food allergy patient community is satisfied with the proposed "Ten-for-One" deal ... fine.  I just wanted to make sure that the patient community understood that this may be where things are headed.

Deciding on the appropriate level of regulations is often sort of a dance/game between consumers/patients and industry imo ... a negotiation ... $$$, power, influence, media/PR, lobbying & voting all come into play ... but consumers/patients have to remain informed & active if they want a government that is responsive to the needs of "the people", regular citizens.

-----------------

Something Jimmy Kimmel said the other day resonates with me ...

"Jimmy Kimmel: Sen. Bill Cassidy 'failed' his own test on health care"
By DAN DIAMOND, 09/20/2017 12:16 AM EDT
http://www.politico.com/story/2017/09/20/jimmy-kimmel-bill-cassidy-obamacare-242913

Quote"Health care's complicated [and] it's boring; I don't want to talk about it [and] the details are confusing," Kimmel said in his monologue. "And that's what these guys are relying on. ... They're taking care of the people who give them money, like insurance companies."

The same kind of thing imo ... FDA regulations can be kind of boring and complicated ... but if regular citizens/patients don't pay
attention, public health can be negatively affected.

"Food Allergy Research & Education Joins with National Academies of Sciences, Engineering and Medicine in Call for Sweeping Changes to Improve Health, Quality of Life of Individuals With Food Allergies"

November 30, 2016

https://www.foodallergy.org/about/media-press-room/food-allergy-research-education-joins-national-academies-sciences

QuoteFood Allergy Research & Education (FARE) is the lead sponsor of this report

QuoteIn discussing the need for improved policies regarding labeling of packaged foods, the expert committee is recommending that the priority list of food allergens in the U.S. be periodically reviewed, noting that evidence of allergy prevalence and reaction severity to sesame may warrant inclusion on this list.

----------------------------------------


"National Academies Consensus Study"

https://www.foodallergy.org/research-programs/national-academies-consensus-study

QuoteFARE and other groups nominated the members of the expert panel and the volunteer patient advisory panel.

QuoteFARE also assisted in securing diverse co-sponsors to provide funding support for the study.

------------------------------------------------------


"Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy"
Released: November 30, 2016
http://nationalacademies.org/hmd/reports/2016/finding-a-path-to-safety-in-food-allergy.aspx

Click on the "Committee Members" & "Sponsors" sections ...

Two of the things that jumped out immediately to me were that Dr. Stephen Taylor was on the committee & there seemed to be a lot of sponsors from industry.

If FARE had so much influence in setting this up and if FARE is a patient org representing patient interests ... why such heavy industry involvement?  Yes, all stakeholders need to be at the table ... but for instance if Dr. Taylor is going to be included, why not also have a food science expert that is more closely associated with patients/consumers to balance things out, to help with potential COI & bias issues?  Am I mistaken (sincere question)?  Is there such an expert on the committee that I'm not recognizing?

For some more background that might help explain why I am concerned, see:

Re: sesame seeds labeling: US specific (laws, loopholes)

&

Re: sesame seeds labeling: US specific (laws, loopholes)

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I was pleased to see that the:

Quotecommittee had the unique opportunity to hear directly from an advisory panel made up of nine parents of children with food allergies and one individual with food allergy

https://www.nap.edu/read/23658/chapter/1  (Page x) .

However, I didn't see any patients on the committee itself or listed as reviewers (please feel free to correct me if I am wrong).

This sentence from Rosamund Snow came to mind:

QuoteWe're allowed to remind the researchers why they went into the job in the first place, but we're not supposed to be able to comment on methodology, even if the methodology is flawed because the researchers aren't aware of their own biases.

"Rosamund Snow: What makes a real patient?"
July 19, 2016
http://blogs.bmj.com/bmj/2016/07/19/rosamund-snow-what-makes-a-real-patient/


Another thing that came to mind was power & influence ... being on the committee is much different than being on an advisory panel.

-------------

Back to the main report ... the recommendation that I feel is probably most relevant to the topic of sesame labeling is this:

"Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy"
Released: November 30, 2016
Page 312
https://www.nap.edu/read/23658/chapter/9#312

QuoteFor example, in the United States, some foods listed by the FDA as tree nuts (i.e., beech nut, butternut, chestnut, chinquapin, coconut, gingko nut, hickory nut, lichee nut, pili nut, shea nut) could be removed from the current priority list based on the paucity of data or low frequency of allergic reactions. In addition, evidence of the allergy prevalence and reaction severity to sesame seeds may warrant their inclusion on the priority allergen list in the United States.

What this reminds me of is the general political talk of taking away more regulations than you add:
Re: FDA

but instead of maybe "Two-for-One", is it going to be something like "Ten-for-One" with food allergen labeling?

My opinion is that sesame will eventually get labeled in the USA (as I think it should be), but the real question, the
upcoming "battle" imo, is at what cost?  Will it be one of those cases where even if patients "win", we lose?

Although I'm not too active at FAS anymore, I do read here sometimes, and I saw that somebody was asking about the current status of the sesame labeling efforts .... so I thought that I would update this thread.

---------------------------------

I was a sesame labeling advocate from 2008-2015 ... my comment was included with the 2014 CSPI petition (K.P. - Page 16)

https://www.regulations.gov/document?D=FDA-2014-P-2035-0001

https://cspinet.org/sites/default/files/attachment/11-18-sesame-petition.pdf

I tried lots of tactics over the years trying to get that allergen labeled .... some clever imo ... some naive and kind of embarrassing at this point ... I don't want to rehash everything ...

My daughter has now fully outgrown her sesame allergy ... in fact, she no longer has any IgE allergies ... so I'm not involved in food allergy advocacy anymore.  However, since I did invest so much of myself into this issue, I keep an eye on it from a bit of a distance.

---------------------------------


KFA & AAFA now support efforts to improve sesame labeling:


"Tell the FDA to List Sesame as a Major Food Allergen on Food Labels"
3/6/17
https://community.kidswithfoodallergies.org/blog/aafa-supports-labeling-for-sesame

QuoteThe Asthma and Allergy Foundation of America (AAFA) is standing up for people allergic to sesame. We joined with a consumer advocacy group to ask the Food and Drug Administration (FDA) to add sesame to the list of ingredients that must be disclosed on food labels.

-----

http://www.aafa.org/media/CSPI-AAFA-Comments-Sesame-Labeling.pdf

QuoteWe urge the FDA to include sesame among the list of ingredients that must be disclosed

-----

Comment from Center for Science in the Public Interest CSPI and Asthma and Allergy Foundation of America AAFA
https://www.regulations.gov/document?D=FDA-2014-P-2035-0034

---------------------------------


FARE is also on board now ...


"FARE Supports Calls for Addition of Sesame as a Major Food Allergen"

July 1, 2015

https://www.foodallergy.org/about-fare/blog/fare-supports-calls-for-addition-of-sesame-as-a-major-food-allergen

QuoteAs the leading advocacy organization representing the 15 million Americans with food allergies, FARE supports the addition of sesame to the list of "major food allergens" that are required to be identified on ingredient labels of processed foods.

---------------------------------


So you might be thinking that things are looking pretty good ... the allergy orgs are backing sesame labeling ...
but keep reading, if you would ...

Sesame Allergy
http://www.foodallergy.org/allergens/sesame

Quote
Sesame is not currently included in the list of major allergens that must be declared by food manufacturers as part of the Food Allergen Labeling Consumer Protection Act (FALCPA), although FARE supports the addition of sesame to the list of "major food allergens" that are required to be identified on ingredient labels of processed foods.

QuoteThe list below includes information about ingredients to avoid if you have a sesame allergy, including uncommon names for the ingredient.

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Linking ...

Efforts to add Sesame as Top Allergen

Thank you for sharing that Links. 

Lobbying for Sesame Labeling in Washington, D.C.
MAY 18, 2015

https://ohmahdeehness.wordpress.com/2015/05/18/lobbying-for-sesame-labeling-in-washington-d-c/

Brian,

Most of us sesame folks at FAS have already signed your petition.  I support it & the CSPI petition.  Thank you for your efforts to help those with sesame allergies.

Please sign this petition to the FDA requiring better labeling of sesame https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels  Anyone can sign this informal petition on Change.org, but the more signatures, the more they will take notice. 

FYI:  This informal petition led to a more formal "citizen's petition" by CSPI, which is not the type that take signatures, but rather, is the type the FDA must reply to by law!  http://cspinet.org/new/201411181.html

Again, here's where to sign the original petition that started it all:  https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels 

Tweeted by @parisreview


"Alice Munro, The Art of Fiction No. 137"
http://www.theparisreview.org/interviews/1791/the-art-of-fiction-no-137-alice-munro

QuoteThere should be a point where you say, the way you would with a child, this isn't mine anymore.

http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-3230-0001

QuoteAll comments submitted to any FDA docket on or after October 15, 2015, will be publically posted, unless otherwise determined not to be subject to posting as described in the SUPPLEMENTARY INFORMATION section.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration [Docket No. FDA–2015–N–3230]
Consumer Comments—Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

QuoteSUMMARY: The Food and Drug Administration (FDA or Agency) is changing the Agency's long standing practice of not publically posting on http://www.regulations.gov comments submitted by individuals in their individual capacity. These are generally comments from people who self-identify as an ''individual consumer'' under the field titled ''Category (Required)'' on the ''Your Information'' page on http:// www.regulations.gov. Changing FDA's practice to routinely post these comments, as we do other comments, will increase the transparency and public utility of FDA's public dockets.
It will better enable our public dockets to function as intended: To share information and encourage an open exchange of ideas.

QuoteThis change fulfills a recommendation from the 2010 FDA Transparency Initiative

 

"Understanding and Managing Sesame Allergy (Webinar Recording and Recap)"
http://blog.foodallergy.org/2015/10/22/understanding-and-managing-sesame-allergy-webinar-recording-and-recap/#_ga=1.251041477.23381587.1434562410

QuoteOn Wednesday, October 14, FARE was joined by Dr. Robert Wood, for a webinar titled Understanding and Managing Sesame Allergy.

QuoteMr. Riccio encouraged webinar attendees to share their sesame allergy stories with FARE, sign up for advocacy alerts, and let their congressmen/women know that adding sesame FALCPA is an issue important to their families.