Wednesday, January 6, 2021

My January 6, 2021, Open Letter to the FDA Re: Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)

Posted on the FDA's Facebook page:
https://www.facebook.com/FDA

Dear FDA:

Re:  Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)

The FDA has made a critical error in 21CFR184.1857, which is endangering the lives of corn-allergic consumers and patients.

DOCUMENTED ERRORS:

The FDA is erroneously equating blood sugar present in all living organisms (glucose) with corn sugar manufactured from cornstarch (D-glucose/dextrose). You have assigned the molecular formula for corn sugar manufactured from cornstarch (dextrose/D-glucose) with the same molecular formula for blood sugar present in all living organisms (glucose), C6H12O6.  This would mean that corn sugar manufactured from cornstarch (dextrose/D-glucose) would have to be synthesized to achieve the same molecular formula as blood sugar present in all living organisms (glucose), C6H12O6.  Does the FDA have documentation for this synthesization process? 

The correct molecular formula in 21CFR184.1857 should be C6H14O7.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Blood sugar present in all living organisms (glucose) cannot be equated with D-glucose (corn sugar manufactured from cornstarch/dextrose), since D-glucose (corn sugar) is NOT the same as glucose (blood sugar).  Glucose (blood sugar present in all living organisms) cannot provoke an allergic response; whereas, corn sugar manufactured from cornstarch (dextrose/D-glucose) can prove fatal to individuals with an IgE-mediated allergy to corn.  It is for this reason that IV fluids to which corn sugar (dextrose/D-glucose) has been added are contraindicated for administration to corn-allergic patients in the package insert.

Corn Sugar (Dextrose/D-Glucose) IV Fluids Contraindicated for Corn-Allergic Patients
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

Since D-glucose is the common commercial name for dextrose (corn sugar manufactured from cornstarch), the following molecular formula for D-glucose is also INCORRECT.

D-Glucose, Molecular Formula C6H12O6
[This molecular formula is not only incorrect, it is also inconsistent with the molecular formula for corn syrup and dextrose (see documentation below).]
https://pubchem.ncbi.nlm.nih.gov/compound/5793

Corn sugar (dextrose/D-glucose) is NOT "produced by the liver" nor is it "glucose" (blood sugar present in all living organisms).  This explains why clinicians continue to endanger the lives of corn-allergic patients if they refer to this false and misleading definition of dextrose (corn sugar/D-glucose).
https://www.drugs.com/dextrose.html

DOCUMENTATION:

"Corn must first be converted to corn sugar (dextrose, the common commercial name for D-glucose) . . ."
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/

Corn Syrup, Molecular Formula C6H14O7
[Note that corn syrup is corn sugar (dextrose/D-glucose) to which water has been added.]
https://pubchem.ncbi.nlm.nih.gov/compound/5282499

Cornstarch, Molecular Formula C27H48O20
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/24836924

Dextrose, Molecular Formula C6H14O7
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/DEXTROSE

DEXTROSE (CORN SUGAR/D-GLUCOSE) LABELING REQUIREMENTS:

It is our understanding that if dextrose (corn sugar/D-glucose) is an ingredient, the word "dextrose" must appear on the product label; e.g., iodized salt lists "dextrose" as an ingredient. However, they are not required to explain that dextrose is "D-glucose/corn sugar manufactured from cornstarch." If dextrose is required, then dextrose equivalent (DE) should also be required on product labels since they are "one and the same" based on the fact that dextrose equivalent (DE) is only derived from corn. Both can prove lethal to corn-allergic consumers.  Many food retailers, manufacturers, and distributors are confusing dextrin with dextrose, claiming their dextrose products are derived from food sources other than corn.  They are clearly confusing dextrose with dextrin.  

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn.
Corn Sugar (Dextrose/D-Glucose), Code of Federal Regulation 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Confirmation that dextrose equivalent (DE), corn sugar/D-glucose, is only derived from corn.
https://www.austradeinc.com/products/sweeteners/

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn.
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf

Dextrin (usually sourced from corn) may be sourced from food products other than corn. Code of Federal Regulation 21CFR184.1277
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1277

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn. Dextrin (usually derived from corn) may be derived from food products other than corn.
[Cites food retailers, manufacturers, and distributors who are falsely claiming that dextrose is derived directly from tapioca, which endangers the lives of corn-allergic consumers.]
https://cornallergyadvocacyresources.blogspot.com/2020/12/confirmation-that-dextrose-corn-sugard.html

WHY IS THIS CORRECTION BY THE FDA NECESSARY?

One of the primary complaints in our corn allergy support groups of over 13.5K members [more than double the membership in sesame seed allergy support groups] is that the majority of medical professionals are erroneously equating corn sugar manufactured from cornstarch (dextrose/D-glucose) with blood sugar present in all living organisms (glucose). As a result, they continue to insist upon administering dextrose-containing IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.  Administering corn sugar (dextrose/D-glucose) IV fluids to corn-allergic patients is a critical medical error equivalent to administering penicillin to patients with an allergy to penicillin; therefore, without this critical correction by the FDA, physicians are at risk for potential liability.   We should not be required to educate clinicians for our own safety, and the FDA needs to be more proactive in educating clinicians about the critical difference between glucose (blood sugar) and D-glucose (corn sugar/dextrose).  

In addition, many food retailers, manufacturers, and distributors are claiming their products are corn free; when, in fact, they contain dextrose (or other corn-derived ingredients), which can prove fatal to corn-allergic consumers.
  Corn may be exempt from FDA labeling requirements; however, they also risk liability if even one ingredient is derived from corn, yet they claim their products are corn free.  We should not be required to educate food retailers, manufacturers, and distributors for our own safety; e.g., one retailer claimed their product was corn free when, in fact, it contained corn-derived allulose  Thankfully, this manufacturer removed their corn-free claim at our request; since the product could have proven fatal to corn-allergic consumers.  Therefore, the FDA needs to be more proactive in educating food manufacturers regarding corn-derived ingredients. 

Many clinicians, food retailers, manufacturers, and distributors are falsely equating blood sugar present in all living organisms (glucose) with corn sugar (dextrose/D-glucose) based on these erroneous and conflicting molecular formulas; and, as a result, the lives of corn-allergic consumers and patients remain in constant danger.  

WHAT ARE OUR OPTIONS FOR EFFECTING THESE CRITICAL CORRECTIONS?

I, on behalf of the corn allergy community, would like to send a certified letter to the responsible party or agency exposing these critical errors with a request that these errors be corrected immediately.  Please provide me with the applicable contact information for directing my certified letter.

I have already provided indisputable documentation to the NIH National Library of Medicine; however, they are adamant that blood sugar present in all living organisms (glucose) is "one and the same" with corn sugar manufactured from cornstarch (dextrose/D-glucose).  They do not understand the critical difference between glucose (blood sugar) and D-glucose (corn sugar/dextrose).  In addition, they are ignoring the molecular formula assigned to dextrose and corn syrup (C6H14O7) that is documented in their own database.

Thank you very much for your attention to this critical concern.

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

Additional References:

My September 29, 2020, Email to Baxter Healthcare Ltd Re: Dextrose IV Fluid
https://cornallergyadvocacyresources.blogspot.com/2020/09/my-september-29-2020-email-to-baxter.html

Glucose (blood sugar) must NEVER be equated with dextrose (corn sugar manufactured from cornstarch).
[This petition does NOT solicit donations.]
PETITION: Defund the NIH National Library of Medicine for Willful Negligence
https://www.change.org/p/united-states-department-of-health-human-services-defund-the-nih-national-library-of-medicine-for-willful-negligence

Corn Allergen Lists of Corn Products/Corn-Derived Ingredients to be Avoided
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

Corn Allergy References, Surveys, Studies (“. . . Maize major allergen . . .”), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html


Blog Post Reference Link:

My January 6, 2021, Open Letter to the FDA Re: Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)
https://cornallergyadvocacyresources.blogspot.com/2021/01/my-january-6-2021-open-letter-to-fda-re.html

 

 

 

 

 

 

 

Saturday, December 26, 2020

My November 25, 2020, Email to True Nutrition Re: Brown Rice Dextrose

UPDATE DECEMBER 26, 2020:  True Nutrition has deleted their claim that their 100% dextrose is derived from "brown rice."

To:  True Nutrition, Email: info@truenutrition.com

Re:  True Nutrition Dextrose

I placed a call to your company yesterday, and the representative suggested I send you an email regarding True Nutrition Dextrose.

I recently conducted an oral challenge of "organic tapioca dextrose" from a complimentary sample provided by a wholesaler, and suffered a severe allergic reaction.  It turned out that corn sugar (dextrose) was ADDED TO this product in the form of "dextrose equivalent (DE)" which is what caused my allergic response.  As a result of this oral challenge, we now realize there is no such thing as "tapioca dextrose."  Based on my allergic reaction, the wholesaler is reconsidering the labeling of this product which is actually "organic tapioca powder with dextrose (corn sugar manufactured from cornstarch)."

I would appreciate your confirmation that your "100% Dextrose" is, in fact, derived from "brown rice."
https://truenutrition.com/p-5105-dextrose-1lb.aspx

Thank you very much, and I look forward to conducting an oral challenge of this product on behalf of the corn allergy community.  


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  
cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

References:

CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

CORN SUGAR (DEXTROSE) IV FLUIDS CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

Dextrose: Facts vs. Fiction
https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

Glucose (blood sugar) must NEVER be equated with dextrose (corn sugar manufactured from cornstarch).
[This petition does NOT solicit donations.]
PETITION: Defund the NIH National Library of Medicine for Willful Negligence
https://www.change.org/p/united-states-department-of-health-human-services-defund-the-nih-national-library-of-medicine-for-willful-negligence


Blog Post Reference Link:

My November 25, 2020, Email to True Nutrition Re: Brown Rice Dextrose
https://cornallergyadvocacyresources.blogspot.com/2020/12/my-november-25-2020-email-to-true.html


Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn. Dextrin (usually derived from corn) may be derived from food products other than corn.

Submitted to my state FDA consumer complaint coordinator:

After providing Wikipedia contributors with indisputable documentation confirming that dextrose (corn sugar/D-glucose) is only derived from corn, I was permanently banned from my Wikipedia talk page. They, in turn, stated that dextrose can be derived from sources other than corn; e.g., tapioca. However, they provided no documentation supporting their claims. 

Based on the statements by Wikipedia contributors, I contacted a distributor of "Organic Tapioca Dextrose" who sent me a complimentary sample of their product. Since I am not allergic to tapioca, on November 19, 2020, I consumed one level teaspoon of this product dissolved in a glass of filtered water in the presence of a witness (in the event my corn allergy reactions were to escalate to anaphylaxis). I suffered a severe 8-hour allergic reaction to this product requiring two antihistamines and two prednisone tablets. The cause of my allergic response was due to the fact that corn sugar manufactured from cornstarch, in the form of dextrose equivalent (DE), was ADDED TO this product. The dextrose was NOT DERIVED FROM TAPIOCA as the product label implied, thereby endangering the lives of corn-allergic consumers.

Dextrose (corn sugar/D-glucose) is only derived from corn:

Pursuant to Code of Federal Regulation 21CFR184.1857:

Dextrose = corn sugar manufactured from cornstarch = D-glucose
Dextrose = D-glucose = corn sugar manufactured from cornstarch
Corn sugar manufactured from cornstarch = dextrose = D-glucose
Corn sugar manufactured from cornstarch = D-glucose = dextrose
D-glucose = dextrose = corn sugar manufactured from cornstarch
D-glucose = corn sugar manufactured from cornstarch = dextrose

In addition, since dextrose/D-glucose is corn sugar manufactured from cornstarch, it cannot be naturally occurring; therefore, it cannot be naturally present in any other food/drug/biologic products.
 It is always an ADDED ingredient to these products.

Confirmation that dextrose is only derived from corn.
Corn Sugar (Dextrose/D-Glucose), Code of Federal Regulation 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Confirmation that dextrose equivalent (DE) is only derived from corn.
https://www.austradeinc.com/products/sweeteners/

Confirmation that dextrose is only derived from corn.
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf

Confirmation that the "D" in D-glucose represents "dextrose" (corn sugar manufactured from cornstarch).
"Corn must first be converted to corn sugar (dextrose, the common commercial name for D-glucose) . . ."
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/

 D-Glucose Monohydrate (corn sugar manufactured from cornstarch to which molecules of water have been added) is contraindicated for administration to corn-allergic patients.

"CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products."
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf

Intravenous solutions to which corn sugar (dextrose/D-glucose) has been added are contraindicated for administration to corn-allergic patients in the package insert.
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

False claims by food manufacturers/distributors: 

The following food manufacturers/distributors are falsely implying that dextrose is derived from tapioca. [An Internet search of wheat dextrose and rice dextrose should also be conducted, since these claims would also be false.]

Certified Organic Tapioca Dextrose, Parchem
[Documentation forwarded to them via email, 12/15/2020.]
https://www.parchem.com/chemical-supplier-distributor/Certified-Organic-Tapioca-Dextrose-006117.aspx

Tapioca Dextrose, Mike’s Mix
[Note that they are also claiming this product is corn free, which endangers the lives of corn-allergic consumers. I have exchanged over 35 emails with this company since September, 2020, and they refuse to redact their corn-free/tapioca dextrose claims.]
https://mikesmixture.com/products/tapioca-dextrose?_pos=1&_sid=2b7cb53cb&_ss=r

Tapioca Starch Dextrose, Alibaba.com
https://www.alibaba.com/product-detail/tapioca-starch-dextrose-fufeng-dextrose_62108273451.html?spm=a2700.7724857.normal_offer.d_image.3a3d1eb9747CbL

Tapioca Starch Dextrose Monohydrate, Alibaba.com
https://www.alibaba.com/product-detail/tapioca-starch-dextrose-monohydrate-bulk-glucose_62108429284.html?spm=a2700.7724857.normal_offer.d_image.3a3d1eb9747CbL

Tapioca Dextrose, A. G. Commodities, Inc.
[Sent email 12/27/20, and it appears they are in the process of correcting their website.]
http://www.tapiocadextrose.com/

Tapioca Dextrose, Protein Muffins, Trader Joe’s
https://www.traderjoes.com/FearlessFlyer/Article/5498

Organic Tapioca Dextrose, Nature’s Flavors
[Sent email 12/30/20.]
https://www.naturesflavors.com/organic-ingredients/63825-organic-dextrose-powder-kosher-vegan-gluten-free.html?search_query=tapioca+dextrose&results=4

Tapioca Dextrose Monohydrate, Essex Food Ingredients
[Sent documentation to them on 12/2/2020 via online contact form.]
https://essexfoodingredients.com/product/tapioca-dextrose-monohydrate/

Dextrose (Tapioca Derived)
[Sent documentation to them on 11/25/2020 via email.]
http://www.ffi-corp.com/products.asp

It appears that these food manufacturers/distributors are confusing "dextrin" with "dextrose." 

Dextrin, Code of Federal Regulation 21CFR184.1277
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1277

Conflicting molecular formulas:

Since I am challenging the molecular formula for corn sugar (dextrose/D-glucose) as defined in Code of Federal Regulation 21CFR184.1857, the FDA recently advised me to file a citizen’s petition addressing the following conflicting molecular formulas. I am in the process of drafting this petition.

The NIH National Library of Medicine informed me in an email that blood sugar present in all living organisms (glucose) and corn sugar manufactured from cornstarch (dextrose/D-glucose) are "one and the same." Blood sugar (glucose) cannot provoke an allergic response; whereas, corn sugar manufactured from cornstarch (dextrose/D-glucose) can prove fatal to anyone with an IgE-mediated allergy to corn. Therefore, based on the following molecular formulas in PubChem documents, I am requesting that the FDA provide documentation confirming that corn sugar (dextrose/D-glucose) and blood sugar present in all living organisms (glucose) are biochemically identical ("one and the same") as defined in Code of Federal Regulation 21CFR184.1857. It is my contention that molecular formula C6H14O7 should be applied to corn sugar (dextrose/D-glucose) to accurately reflect the critical difference between blood sugar present in all living organisms (glucose) and corn sugar manufactured from cornstarch (dextrose/D-glucose). 

Corn Syrup, Molecular Formula C6H14O7
[Note that corn syrup is corn sugar to which water has been added.]
https://pubchem.ncbi.nlm.nih.gov/compound/5282499

Cornstarch, Molecular Formula C27H48O20
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/24836924

Dextrose, Molecular Formula C6H14O7
[Note that dextrose/D-glucose is corn sugar manufactured from cornstarch.]
https://pubchem.ncbi.nlm.nih.gov/compound/DEXTROSE

Dextrose Monohydrate, Molecular Formula C6H14O7
[Note that this is the same molecular formula as corn syrup, since water has been added to dextrose; i.e., "monohydrate."]

Additional false statements in this publication:

"A primary source of energy for living organisms. It is naturally occurring and is found in fruits and other parts of plants in its free state."
[Glucose (blood sugar) is "A primary source of energy for living organisms" -- NOT corn sugar manufactured from cornstarch (dextrose/D-glucose).]

"It is naturally occurring and is found in fruits and other."
[Corn sugar manufactured from cornstarch (dextrose/D-glucose) is an ADDED ingredient to food/drug/biologic products. It is NOT naturally occurring, and the only way it can be found in other products is through the deliberate addition into that food/drug/biologic product.]
https://pubchem.ncbi.nlm.nih.gov/compound/22814120

Since the molecular formula for dextrose is C6H14O7, corn syrup is C6H14O7, cornstarch is C27H48O20, and dextrose monohydrate is C6H14O7, this would mean that corn sugar manufactured from cornstarch (dextrose/D-glucose) would have to be synthesized to achieve the molecular formula of blood sugar present in all living organisms, C6H12O6. The FDA should have documentation of this synthesization process. 

Why is this important?

One of the primary complaints in our corn allergy support groups of over 13.5K members is that the majority of medical professionals are erroneously equating corn sugar manufactured from cornstarch (dextrose/D-glucose) with blood sugar present in all living organisms (glucose). As a result, they continue to insist upon administering dextrose-containing IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert. In addition, many food manufacturers are claiming their products are corn free; when, in fact, they contain dextrose (or other corn-derived ingredients), which can prove fatal to corn-allergic consumers.


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

Additional References:

Dextrose: Facts vs. Fiction
https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

Corn Allergy References, Surveys, Studies (". . . Maize major allergen . . . "), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html


Blog Post Reference Link:

Confirmation that dextrose (corn sugar/D-glucose) is only derived from corn. Dextrin (usually derived from corn) may be derived from food products other than corn.
https://cornallergyadvocacyresources.blogspot.com/2020/12/confirmation-that-dextrose-corn-sugard.html


Thursday, November 19, 2020

Electronic Health Records (EHRs) Endanger Patients’ Lives Based on Patient Testimonies, and Expose Physicians to Potential Liability

 Reported to the Electronic Health Record Association
@EHRAssociation, October 1, 2020


INCIDENT #1
:  Electronic Health Records (EHRs) must never automatically diagnose patients based on prescribed drugs.

A Patient’s Personal Testimony Reprinted with Permission

A lifelong hypotensive patient is taking a small dose of atenolol for abnormal heart rhythms (history of premature ventricular contractions) which is clearly documented in the patient's medical records.  However, the Electronic Health Record (EHR) software program automatically diagnosed this patient with "high blood pressure" based on the prescribed medication.  This patient's hypotension is so severe that the patient’s cardiologist prescribed fludrocortisone to raise his/her blood pressure; however, due to an adverse reaction, the patient had to discontinue the medication.

Several years ago, this patient provided a hospital with a written statement that he/she was taking atenolol for premature ventricular contractions (PVCs) — NOT for blood pressure issues.  The patient's medical records at this facility still reflect that this patient has "high blood pressure" in the patient's official medical records, which is a direct result of this critical glitch in the Electronic Health Record (EHR) software program.  Even though the patient had submitted a written statement to the hospital confirming the purpose for taking this drug, the patient gave up trying to correct this error in his/her medical record due to the "red tape nightmare" involved with effecting this correction.  Therefore, this patient will never be able to disclose to any other medical provider that he/she is taking this particular drug due to the automatic misdiagnosis of "high blood pressure" that will be recorded in the patient's official medical records.

In consultation with one of the subject patient's other physicians, the patient was forced to lie to this physician indicating the patient is no longer taking atenolol.  This patient indicated that he/she will inform his/her remaining medical providers that he/she is no longer taking this drug to guarantee the patient's safety and to maintain the integrity of the patient's official medical records.  The only medical record reflecting that the patient is taking this drug will be maintained by the patient's prescribing physician with an alert that this drug is prescribed for abnormal heart rhythms; however, there is still no guarantee that the Electronic Health Record (EHR) software program will not misdiagnose this patient in the future based on this prescribed drug. 

It is also important to note that the patient caught the misdiagnosis of  "high blood pressure" in his/her medical record while using the electronic tablet just prior to the patient’s appointment with the prescribing physician.  Therefore, it is of critical importance that all patients carefully review the "diagnosed medical conditions" indicated in their medical records with each physician consultation.   

Atenolol can be used to treat conditions unrelated to blood pressure control; however, the Electronic Health Record (EHR) software program automatically chose the predominant condition and applied it to this patient’s official medical records.

https://www.webmd.com/drugs/2/drug-11035/atenolol-oral/details

https://www.nhs.uk/medicines/atenolol/#:~:text=Atenolol%20belongs%20to%20a%20group,disease%2C%20heart%20attacks%20and%20strokes
.

Conclusion:

The automatic diagnosis of a patient by a flawed, computer-generated software program endangers patients’ lives.  It also places physicians at risk for potential liability.  This patient’s hypotension was clearly noted in the patient’s hospital medical record prior to surgery.  What if an emergency situation had developed during this patient’s surgical procedure; and the surgeon treated this patient based on a diagnosis of "high blood pressure" due to the surgeon’s reliance on the diagnosis that was generated by the Electronic Health Record (EHR) software program resulting in harm, or even death, of this patient?   The liability for this critical medical error rests solely with the physician.

How many other patients’ lives are currently in danger due to the critically flawed Electronic Health Record (EHR) software program?

Since Electronic Health Records (EHRs) must never diagnose a patient based on prescribed medications, immediate attention to this issue is required.


INCIDENT #2:  Electronic Health Records (EHRs) must never "selectively censor" a patient’s allergens (or derivatives thereof).

The FDA states that people can suffer allergic reactions to more than 160 foods, but that only eight of these foods have been declared official allergens subject to FDA labeling requirements since these foods represent approximately 90 percent of allergic reactions.
https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-food-allergies

In response to my recent inquiry submitted to the FDA requesting documentation of the "90 percent" claim, Case #247585, the FDA provided me with the following cited article.

J. Bousquet, et al., confirm in their article "Scientific criteria and the selection of allergenic foods for product labelling" that although the Top 8 allergens account for over 90% of food allergies, ". . . there is a much longer list of other foods and food ingredients that have been associated with allergic reactions in sensitive individuals."  [emphasis added]
https://pubmed.ncbi.nlm.nih.gov/10100969/

A patient's official medical record must reflect all of a patient's IgE-mediated allergies (and derivatives thereof), whether it's an allergy to lettuce or peanuts.  Selectively censoring the option to record all of a patient's confirmed IgE-mediated allergies not only endangers the lives of patients, but also places the physician at risk for liability.  Bear in mind that there is usually a written account of a patient’s allergies in their medical records.  Selectively censoring a patient’s allergens in the EHR does not protect the physician from potential liability if the physician prescribes/administers a drug/biologic product containing excipients of the patient’s allergens, even though no contraindication warning is indicated in the package insert.

My Doctor Prescribed the Wrong Medication. Is It Medical Malpractice? By Prathyusha Chowdri
"The doctor prescribes a medication which contains an ingredient to which the patient is allergic." [emphasis added]
https://www.nolo.com/legal-encyclopedia/my-doctor-prescribed-the-wrong-medication-is-malpractice.html

It is the patient's responsibility to inform their physician of their IgE-mediated allergies; however, it is their physician's responsibility to verify that the prescribed drug/biologic products do not contain the patient's allergens or derivatives thereof; i.e., corn-allergic patients must be able to list the following corn products/corn-derived excipients in the EHR.

Corn Allergen Lists
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

Without the ability to include these excipients in the EHR, the physician is required to contact drug/biologic manufacturers to verify if prescribed drugs contain corn-derived excipients; since most physicians are unfamiliar with the dangers of non-medicinal ingredients (NMIs) in these products. 

93 percent of medications contain 'potential allergens'
https://www.medicalnewstoday.com/articles/324681

"Inactive" ingredients in oral medications
https://stm.sciencemag.org/content/11/483/eaau6753

Non-medicinal ingredients don’t appear on drug labels
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

Please refer to the following articles which explain why the EHRs need to be expanded for patients with an IgE-mediated allergy to corn, e.g., corn-allergic patients must be able to list an allergy to fresh food products (treated with corn-derived antimicrobial chemical washes) and tap water (corn-derived water purification chemicals), in addition to non-ingestible products, e.g., surgical dressings, dyes, shampoo, soaps, cleaners, toilet paper, fabrics, etc.

"Corn: It's Everything" by Iowa Corn
https://www.iowacorn.org/education/corn-its-everything/

FDA  AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-and-usda-confirm-that-corn-derived.html

A mother's desperate struggle to find safe water for her corn-allergic infant son.
https://cornallergyadvocacyresources.blogspot.com/2019/05/a-mothers-desperate-struggle-to-find.html

Contact-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/06/if-you-are-reacting-to-clothing.html

Inhalation-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/10/inhalation-reactive-to-corn-personal.html

An IgE-mediated allergy to corn can be just as lethal as an allergy to any of the Top 8 allergens.

Corn Allergy Symptoms: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/11/corn-allergy-symptoms-personal.html

When I advised my physician of my IgE-mediated allergy to corn, the EHR only indicated that I was allergic to corn oil.  As a result, I conducted the following survey in one corn allergy group which revealed that EHRs are selectively censoring allergens from a patient’s medical records

Survey:

With the advent of electronic health records, are any of you limited from listing all of the corn-derived ingredients we must avoid into your medical records; e.g., when I listed an allergy to corn, it only indicated that I was allergic to corn oil? 

Why is this important?

If your physician is prescribing a medication for you, and your medical records don't list all of the corn-derived ingredients you are to avoid; he/she wouldn't realize that a prescribed drug would be contraindicated for you.

With your permission, as with my other surveys, I would like to include your replies in the post using only your initials. 

Thank you very much!

Survey Responses Reprinted with Permission:

Corn wasn’t even an option for referring me to an allergist. My doctor had to select "unknown food allergies." My medical record didn’t have a space to put corn. My doctor couldn’t even put corn on the referral to get me tested. It’s not recognized by the medical network I was in prior to my diagnosis.  My PCP couldn’t believe he couldn’t select corn.

[My question to this respondent: So how was the matter resolved?]

It never was. I switched medical networks and it’s now in my file. It was added by my allergist, though, so I don’t know if I’d be able to add it myself. I know with my kid’s record, I can manually add allergies.E.B.

My doctor has me listed as being allergic to corn meal. It was the only corn option on their list. – L.Z.

I was told that they would have to get clearance from a coder to add those as an allergy and that it would most likely never happen because they are rare "allergies."  I've worked in a lot of hospital systems that had different EHR programs. I know that it's possible. They can make a grouping of the corn derivatives. It's the fact that the medical coder doesn't want to build each one. If you could list all of the derivatives in the EHR, it would automatically alert the prescribing physician and pharmacist that the prescribed medication is contraindicated for the patient.  It could at least narrow it down to say can you call a compounding pharmacy to compound this drug without [insert ingredient], and would be a quick and easy tool to find the "cleanest" medications.  I was recently talking to a pharmacist at Express Scripts, and he indicated they could only list cornstarch and corn oil. When I showed him the corn derivative list, he stated that they don't have derivatives of anything on the EHR. This is important since your doctor is the first person responsible for prescribing drugs that do not contain your allergen.  The second person is the pharmacist who is referencing an EHR that is currently incomplete.  – A.C.

Literally went to the ER for an allergic reaction that was affecting my breathing, etc., and they tried to give me meds with corn even though it was listed on my chart. I actually left sicker than when I went in. I refused 2 of the 3 medicines.  The one I did take was anti-nausea and it made me throw up because it had corn in it, but they had already injected it in the IV so it was too late and I had to ride it out.  It scares me because what if I had been unconscious and couldn't say no? I was already going anaphylactic, and then they gave me more of what I was allergic to. I'm literally terrified of having to go to the ER in the future. – K.U.

I emailed a PDF, provided a physical copy, and personally discussed a list of corn allergy triggers with my doctor. They were able to attach it to my electronic chart. However, it cannot trigger the automatic pop-up that lets the doctor know that a prescription may be contraindicated. I still have to be alert to remind them of my allergy and discuss each prescription and procedure individually. – S.W.

My chart says I am allergic to "corn oil (food) " as well, as it was the only option to mark in their system. I don’t understand why they can’t just type something in. – M.H.

My doctor has the ingredients-to-avoid list. It is in my file but not sure about the electronic file. I give the list to every single doctor I see. Even then, they prescribe meds that are going to cause issues. I am actually being turned down repeatedly by gynecologists because of my allergy. They do not feel they can examine me safely. Seriously!  – D.D.

I've had to go back and ask for medical records to be changed.  I found so many errors. – J.K.

Yes. It is so frustrating! Please include my and my daughter's experiences with this issue. My daughter's chart doesn't even say she's allergic to Dextrose. And when I mention it to the doctors and the nurses they say her corn derivative allergy list is too long to enter into the allergy list that is up front for all to see, but that other nurses can find it in their records and that the word "corn" is enough — but the other nurses can't see the full list! And they have no idea about what comes from corn and what doesn't! It takes them too long to search her chart for her allergy list document and the nurses give up. When I tell them that it's important because she has an anaphylactic allergy to those corn derivatives, and some of them are the names of medications, and I have a list of the derivatives with me, then they just copy the paper that I bring with me, and then enter it again; but no one can ever find it. I have to bring it with me every time she has any kind of appointment in the hospital, or procedure, or emergency visit — which is a lot right now. And the fact that these things are not listed in her chart on the first page with the rest of the allergies and they can't find them right away and I tell them she is anaphylactic to them — that makes them act weird around me, treat me differently — it's like they don't believe me. This has also caused doctors to prescribe medications to my daughter on a regular basis that either the medication itself is directly listed by its name on the list (for example: Polyethylene glycol) and/or medications that have multiple excipients in them that are on the list. I then have to work with the pharmacist (which means the pharmacist hands me the paper from the manufacturer out of the prescribed medication container and I have to search all the fine print; and if the information isn't there, I have to contact the manufacturer) to see if there are corn derivatives in the medication.  If there are corn derivatives, then the pharmacist will look to see if there is a similar medication that she can take that doesn't have anything she's allergic to, or if I have to try to get it compounded, or if she has to go to an alternative type of treatment. – L.H.

Based on using EMRs, I can't imagine that the entire derivatives list would fit under the allergies section.  I do wonder if there could be a subsection under each allergen that would allow the derivatives to be listed where they also list the reaction type. – B.M.

I can never list every derivative we are allergic to. There is no option available. My children’s pediatrician just sits down with me to review the package insert whenever she needs to prescribe anything. If it’s an antibiotic, it gets really complicated and usually takes days to find one for one of my kids, for the other one it must be compounded. – G.D.J.

Prevalence of Corn Allergies:

Corn allergies are NOT rare.  Since corn is ubiquitous and is currently exempt from FDA labeling requirements (including the majority of drug/biologic products), allergic reactions to corn are categorized as idiopathic which results in suppression of corn allergy statistics.  Membership in corn allergy support groups (13.5K) is more than double the membership in sesame seed allergy support groups (6.4K), yet the FDA is considering declaring sesame seed an official allergen subject to FDA labeling requirements.

October, 2020, Month-End Corn Allergy Statistics: 977.7% Increase in 88 Months
https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Published Corn Allergy Studies (". . . Maize major allergen . . . ")
https://cornallergyadvocacyresources.blogspot.com/2017/05/published-corn-allergy-studies.html

Conclusion:

The Electronic Health Record (EHR) system must never engage in "selective censorship" of a patient’s allergens (or derivatives thereof) from a patient’s medical records.  The consequence of this censorship not only endangers the lives of patients, but also places physicians at risk for potential liability if they prescribe/administer drug/biologic products containing excipients derived from a patient’s allergen(s).

Recommendations:

1.  Immediately prohibit Electronic Health Record (EHR) systems from diagnosing patients based on prescribed medications.

2.  Immediately prohibit Electronic Health Record (EHR) systems from "selectively censoring" a patient’s allergens, or derivatives thereof, from their official medical records.

3.  Physicians should appeal to the FDA to mandate contraindication warnings on all drug/biologic products based on the "source of excipients."

 

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

Additional Reference

Corn Allergy References, Surveys, Studies (". . . Maize major allergen . . ."), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

 

Blog Post Reference Link

Electronic Health Records (EHRs) Endanger Patients’ Lives Based on Patient Testimonies, and Expose Physicians to Potential Liability
https://cornallergyadvocacyresources.blogspot.com/2020/11/electronic-health-records-ehrs-endanger.html


Note:  This blog post has been distributed globally, including to all 535 members of Congress.

Wednesday, November 4, 2020

Corn Allergy Symptoms: Personal Testimonies

 A recent poll of one corn allergy support group of nearly 1,500 members with an IgE-mediated allergy to corn was conducted in an effort to document reactions from exposure to corn.  An allergy to corn can be ingestion-reactive, inhalation-reactive, and/or contact-reactive; e.g., I am acutely ingestion-reactive, moderately inhalation-reactive, and slightly contact-reactive. 

Since corn is ubiquitous and is currently exempt from FDA labeling requirements (including the majority of drug/biologic products), allergic reactions to corn are categorized as idiopathic which results in suppression of corn allergy statistics.

Corn Allergy Symptoms: Personal Testimonies:

           Abdominal pain/distention
           Acne
           Anaphylaxis
           Asthma
           Brain fog
           Breathing difficulties
           Bronchial swelling
           Chest pain
           Chest tightness
           Confusion
           Coughing often repetitive
           Cramps
           Depression
           Diarrhea
           Digestive issues
           Dizziness
           Dry mouth
           Dry skin and dry patches
           Eczema
           Elevated pulse rate
           Exhaustion, needing to sleep for days at a time
           Feelings of impending doom
           Fainting spells and lightheadedness
           Flushed skin that turns into extremely pale skin
           Gas
           Headaches
           Hives
           Hoarse voice
           Indigestion
           Itching
           Itchy throat - at the back
           Itchy eyes
           Itchy nose
           Itchy skin
           Itchy tongue
           Lethargy
           Lips swell slightly
           Low heart rate
           Metallic taste in the mouth
           Migraines
           Nasal congestion
           Nausea
           Nonsensical speech
           Pain in sinuses
           Pain in the bridge of the nose
           Pounding heart
           Rashes
           Runny nose
           Sensing that something is wrong with your body
           Skin blisters
           Shortness of breath
           Sneezing
           Stuffy nose
           Suddenly becoming too warm or occasionally feeling too cold
           Swelling and inflammation with pain in hands and feet
           Tachycardia
           Throat feels like it is closing
           Tingling hands
           Tingling mouth
           Tongue may become swollen
           Vomiting
           Weakness
           Weak pulse
           Wheezing

Interesting Facts:

Thankfully due to social media platforms, food allergy support groups (specific and non-specific) are revealing the dramatic increase in food allergies; e.g., membership in corn allergy support groups (12K+) are currently double the membership in sesame seed allergy support groups (6K+), yet the FDA is considering declaring sesame seed an official allergen subject to FDA labeling requirements.

I have been tracking the membership growth of one corn allergy support group which represents a “sample population” for calculating corn allergy statistics (snapshot).  The statistics are probably much higher due to corn allergy members in non-specific allergy support groups, in addition to the fact that many people are suffering with an allergy to corn; however, they don’t recognize their symptoms as a reaction to corn, since corn is exempt from FDA labeling requirements.  As of October, 2020, corn allergy statistics have increased by 977.7% in 87 months.  Another valuable source for confirming the increase in corn allergies would be from compounding pharmacies, since many patients allergic to corn must have their medications compounded to exclude corn-derived excipients.  This documentation can be obtained from the FDA, since they are responsible for auditing compounding pharmacies.

Consider if the following article declared:  "Sesame Seed: It’s Everything" [or any other food product for that matter].  Corn touches nearly every part of our lives, which is why an allergy to corn should be considered a potentially life-threatening diagnosis. 

"Corn: It's Everything," by Iowa Corn
https://www.iowacorn.org/education/corn-its-everything/

 

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

References:

A mother's desperate struggle to find safe water for her corn-allergic infant son.
https://cornallergyadvocacyresources.blogspot.com/2019/05/a-mothers-desperate-struggle-to-find.html

An Allergy to Corn May Contribute to Vitamin/Iodine Deficiencies, in Addition to Dehydration Due to the Lack of Access to Corn-Free Water
https://cornallergyadvocacyresources.blogspot.com/2020/06/an-allergy-to-corn-may-contribute-to.html

"Anger, Aggression, Depression & Identifying Corn In Food," By Jacqueline, Deep Roots at Home, October 19, 2019
https://deeprootsathome.com/corn-ingredients-derivatives-avoid/

Contact-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/06/if-you-are-reacting-to-clothing.html

Corn Allergen Lists [Corn Products/Corn-Derived Ingredients to be Avoided]
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

Corn Allergy: A Potentially Life-Threatening Diagnosis
https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

Corn Allergy for Newbies
https://cornallergyadvocacyresources.blogspot.com/2019/08/corn-allergy-for-newbies.html

Corn Allergy References, Surveys, Studies (“. . . Maize major allergen . . .”), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

Corn Allergy Statistics (Monthly)
https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Dextrose: Facts vs. Fiction
https://cornallergyadvocacyresources.blogspot.com/2020/08/dextrose-facts-vs-fiction.html

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-and-usda-confirm-that-corn-derived.html

FDA CONFIRMS CORN IS EXEMPT FROM FDA LABELING REQUIREMENTS
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-confirms-that-corn-is-exempt-from.html

FDA CONFIRMS CORNSTARCH USED IN PACKAGING MATERIALS IS EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/05/fda-confirms-cornstarch-used-in.html

Inhalation-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/10/inhalation-reactive-to-corn-personal.html

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

"Probable anaphylactic reaction to corn-derived dextrose solution."
https://www.ncbi.nlm.nih.gov/pubmed/1808842

Published Corn Allergy Studies (“. . . Maize major allergen . . .”)
https://cornallergyadvocacyresources.blogspot.com/2017/05/published-corn-allergy-studies.html

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html

STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED
https://cornallergyadvocacyresources.blogspot.com/2020/05/strict-avoidance-of-allergens-is-always.html

"The Surprising Food That May Cause Anger & Aggression," By Jacqueline, Deep Roots at Home, March 18, 2020
https://deeprootsathome.com/the-surprising-food-that-may-cause-anger-aggression/

 Important Notes Regarding the American College of 
Allergy, Asthma and Immunology (ACAAI)

The ACAAI is endangering the lives of corn-allergic consumers w/their statement re: HFCS/other corn products, and have not yet responded to the directive from the FDA, Case #247714, to provide documentation supporting their claims.
https://acaai.org/allergies/types/food-allergies/types-food-allergy/corn-allergy

ACH Foods confirmed that Argo cornstarch contains 0.26 gms of corn protein per 100 gms of cornstarch (sufficient amount to elicit an allergic response). The ACAAI is endangering the lives of corn-allergic infants, and must redact this claim.
https://acaai.org/resources/connect/ask-allergist/infant-formulas-and-corn-allergy

PETITION TO DEMAND THAT THE ACAAI REMOVE FALSE STATEMENT RE: CORNSTARCH AND HIGH FRUCTOSE CORN SYRUP
[The ACAAI has redacted their claim re: cornstarch, but refuses to redact their equally-false claim re: high fructose corn syrup and other corn products.]
https://sign.moveon.org/petitions/demand-that-the-acaai

My March 27, 2018, Certified Letter to the ACAAI  Re: Cornstarch and Corn Syrup
https://cornallergyadvocacyresources.blogspot.com/2018/03/my-march-27-2018-certified-letter-to.html

Argo Cornstarch Oral Challenge to Test Hypothesis Presented by the ACAAI
[Conclusion: If you are allergic/intolerant to corn, do NOT consume cornstarch. I suffered a significant allergic reaction as a result of this oral challenge.]
https://cornallergyadvocacyresources.blogspot.com/2018/03/argo-cornstarch-oral-challenge-to-test.html

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic
https://cornallergyadvocacyresources.blogspot.com/2017/12/removing-food-protein-does-not.html

 

Blog Post Reference Link:

Corn Allergy Symptoms: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/11/corn-allergy-symptoms-personal.html

 

My January 6, 2021, Open Letter to the FDA Re: Critical Difference Between Glucose (Blood Sugar) and D-Glucose (Corn Sugar/Dextrose)

Posted on the FDA's Facebook page: https://www.facebook.com/FDA Dear FDA: Re:  Critical Difference Between Glucose (Blood Sugar) and D-G...