Friday, May 8, 2020

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines

(Refer to my June 20 and June 24, 2020, Emails to the Children’s Hospital of Philadelphia)

[DISCLAIMER]

Each person should consult with their physician concerning vaccinations. 

My only goal as a corn allergy advocate is to protect corn-allergic patients through the respectful education of medical and academic professionals as it relates to the complexities of navigating an allergy to corn.

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April 20, 2020

To:  Children’s Hospital of Philadelphia

Email:  flynnfagad@email.chop.edu

Re:  Corn Allergies and Vaccines

I have been a full-time corn allergy advocate for over six years; and I recently discovered that the information contained in the following article on your website addressing corn allergies is incorrect, which can endanger the lives of corn-allergic patients. 

"News & Views: Vaccines and Allergies"
Published on May 28, 2014 in Vaccine Update for Healthcare Providers

I mean no disrespect; however, since the majority of medical professionals are unfamiliar with the complexities of navigating an allergy to corn, it took me three years to forward corn allergy documentation to our nation's hospitals, colleges of medicine, colleges of pharmacy, CDC, FDA, AMA, NIH, U.S. Department of Health & Human Services, all 535 members of Congress (six times), etc.  My own allergist and primary care physician admitted they were not familiar with the complexities associated with navigating an allergy to corn, and willingly learned with me.

Please understand that vaccines should be contraindicated for corn-allergic patients, since the majority of the excipients are derived from corn.

Thank you for your attention to this critical concern on behalf of corn-allergic patients.

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911


References:

“Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17

DEXTROSE (CORN SUGAR), CODE OF FEDERAL REGULATION 21CFR184.1857

PETITION:  DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

Many medical professionals are missing this critical contraindication warning.
LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

"Probable anaphylactic reaction to corn-derived dextrose solution."

BCPharmacists, "Warning: corn-related allergens . . ."

Dextrose (corn sugar derived from cornstarch) is NOT a drug, but is an ingredient added to drug products.
My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

My February 25, 2018, certified letter to the U.S. Department of Health & Human Services Re: mandate that hospitals stock corn-free foods, fluids, & drugs for the safety of corn-allergic patients.

My Submission to The Joint Commission on Behalf of Corn-Allergic Patients

The ACAAI redacted their false statement regarding cornstarch a year after receiving my certified letter; however, we continue to appeal to them to redact their equally-false statement regarding corn syrup.

My March 27, 2018, Certified Letter to the ACAAI  Re: Cornstarch and Corn Syrup

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.]

Petition to Demand that the ACAAI Remove False Statement Re: Cornstarch/High Fructose Corn Syrup

Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic

Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman
[Thankfully, the AAAAI removed this opinion paper from their website.]

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)
 
United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients

Pharmaceutical Companies Contacted Re: Protocol for Treating Corn-Allergic Patients

March, 2020, Month-End Corn Allergy Statistics: 910.7% Increase in 81 Months
(Corn is ubiquitous and corn allergen warnings are voluntary.)

"A mother's desperate struggle to find safe water for her corn-allergic infant son."

I have to amend the following blog posts, since I recently began reacting to organic fresh-food products.  After contacting the FDA and USDA, they confirmed that ALL fresh food products (including organic) are treated with government-authorized corn-derived antimicrobial chemical washes.

Twitter message to our state Senators yesterday:
"Confirmed by the FDA/USDA: All fresh food products are treated w/government-authorized corn-derived acid washes; therefore, corn-allergic consumers have no safe source of fresh foods (meat, poultry, seafood, fruit, produce). Please advise!

Corn Allergy: A Potentially Life-Threatening Diagnosis

Corn Allergy for Newbies


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To the readers of this blog post:

Please take the time to compare the following corn-derived ingredient list against the CDC’s Vaccine Excipient Summary.  Vaccines contain many corn-derived ingredients; and, therefore, should be contraindicated for corn-allergic patients. 

“Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17

Vaccine Excipient Summary


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UPDATES:

My June 20, 2020, Email to the Children's Hospital of Philadelphia

Re:  Contraindication Warnings Based on “Source of Excipients” in Drug/Biologic Products

The FDA incorrectly advised me in 2018 that corn is NOT exempt from FDA labeling requirements.  Based on factual evidence presented to the FDA, they recently reversed their opinion; and confirmed that corn IS EXEMPT from FDA labeling requirements.  Therefore, allergic reactions to corn are currently categorized as idiopathic, resulting in underreporting and suppression of corn allergy statistics.

We continue to receive reports from the 12K+ members of our corn allergy support groups that physicians continue to prescribe drug/biologic products which contain excipients derived from corn, even though their allergy to corn is documented in their medical records, resulting in allergic reactions (including anaphylaxis).  This is due to the fact that drug/biologic products containing corn-derived excipients do not contain contraindication warnings for administration to corn-allergic patients (with the exception of only a few IV fluids to which dextrose (corn sugar derived from cornstarch) has been added).  This lack of contraindication warnings does not exempt physicians from potential liability for prescribing drug/biologic products to their patients with documented IgE-mediated allergies to the excipients.  It is the responsibility of physicians to contact drug/biologic manufacturers to confirm the source of all excipients prior to prescribing these products. 

Therefore, in an effort to protect physicians from potential liability, in addition to protecting patients with IgE-mediated allergies, I have requested that the FDA issue an emergency mandate that all drug/biologic products contain contraindication warnings based on the "source of excipients.”

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

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911

References:

FDA CONFIRMS THAT CORN IS EXEMPT FROM FDA LABELING REQUIREMENTS

My June 5, 2020, Email to the FDA Re: Emergency Mandate Requiring Contraindication Warnings be Listed for Drug/Biologic Products Based on the "Source of Excipients"

My June 16, 2020, Email to the FDA Re: Corn Labeling in Drug/Biologic Products

My June 8, 2020, Appeal to My State Congressional Representatives Requesting Contraindication Warnings for Drug/Biologic Products Based on the “Source of Excipients”

[I have also forwarded the requisite documentation to Dr. Offit, contributor to this article.]
My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: "Corn Allergies and Vaccines"

My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines

My June 2, 2020, Email to the World Allergy Organization (WAO) Re: Prescribing Drug/Biologic Products to Patients with IgE-Mediated Allergies to Excipients

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

DEXTROSE (CORN SUGAR), CODE OF FEDERAL REGULATION 21CFR184.1857

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]

Additional References:

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE

FDA CONFIRMS CORNSTARCH USED IN PACKAGING MATERIALS IS EXEMPT FROM PUBLIC DISCLOSURE

FDA ADDRESSED MY INQUIRY RE: ABSORBENT PADS USED FOR FRESH FOOD PRODUCTS

FDA ADDRESSED MY INQUIRY RE: FALSE CORN-FREE CLAIMS BY COMPANIES WHOSE PRODUCTS CONTAIN INGREDIENTS DERIVED FROM CORN

FDA CONFIRMS STARCHES IN FOOD PRODUCTS MUST BE IDENTIFIED BY THEIR COMMON OR USUAL NAME

An Allergy to Corn May Contribute to Vitamin/Iodine Deficiencies, in Addition to Dehydration Due to the Lack of Access to Corn-Free Water

If you are reacting to clothing, carpeting, bedding, etc., you may be allergic to CORN!

A mother's desperate struggle to find safe water for her corn-allergic infant son.

Corn Allergy: A Potentially Life-Threatening Diagnosis

Corn Products/Derivatives to Avoid with a Corn Allergy

[Imagine if this article was entitled: "Sesame Seed: It's Everything"]
Corn: It's Everything, Iowa Corn

Corn Allergy References, Surveys, Studies, Statistics, & Petitions
(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

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My June 24, 2020, Email to the Children's Hospital of Philadelphia

Re:  Physicians are Liable for Prescribing Drug/Biologic Products to Patients with IgE-Mediated Allergies to Excipients

This is the email I sent to the FDA/CDC today addressing this critical issue.  In summary, even if a physician prescribed a vaccine to his/her corn-allergic patient based on the incorrect statement on your website regarding corn allergies and vaccines; that physician is still liable if his/her patient suffers an allergic reaction to corn-derived excipients in vaccines.  It is the physician's responsibility to guarantee that drug/biologic products contain no corn-derived excipients PRIOR TO PRESCRIBING these products to their corn-allergic patients. 

The fact that the Children's Hospital of Philadelphia is not aware of the dangers of NMIs (non-medicinal ingredients) in vaccines is quite alarming.  It is for this reason that we, the corn allergy population of the United States, have had to assume the role of respectful educators to medical and academic professionals.  Based on your statement regarding corn and vaccines, I would also be concerned that physicians with the Children's Hospital of Philadelphia may not be cognizant of the contraindication warning for administration of Lactated Ringer's w/5% Dextrose to corn-allergic patients.

My June 24, 2020, Email to the FDA and CDC Addressing Contraindication Warnings for Drug/Biologic Products Based on the Source of Excipients

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

BCPharmacists, "Warning: corn-related allergens . . ."


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources

Twitter:  @CornAllergy911

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STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED:

The FDA recommends strict avoidance of one's allergen.
"Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms, some food allergies can cause severe reactions, and may even be life-threatening.

There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are important measures to prevent serious health consequences."

The ACAAI also recommends strict avoidance:
“Symptoms of a food allergy can range from mild to severe. Just because an initial reaction causes few problems doesn’t mean that all reactions will be similar; a food that triggered only mild symptoms on one occasion may cause more severe symptoms at another time.”

"Patient education: Food allergy treatment and avoidance (Beyond the Basics)," Scott H. Sicherer, MD, FAAAAI, UpToDate, April 25, 2017
"People with food allergies can have serious or even life-threatening reactions after consuming certain foods. The most important strategy in the management of food allergies is to avoid eating these foods."

"Even a tiny amount of the allergy-causing food can trigger signs and symptoms . . ."

Food Allergy & Anaphylaxis Connection Team (FAACT)
"Although food allergy desensitizations are being studied, these are not yet proven treatments, so strict avoidance is the only way to prevent an allergic reaction. 

Trace amounts of an allergen can trigger an allergic reaction in some individuals."










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