Anonymous ID: db2b89 May 20, 2018, 12:13 p.m. No.1483309   🗄️.is 🔗kun

PROPOSED ACTION ITEM FOR BIG PHARMA

Prt 1

 

Localized insulin-derived amyloidosis (LIDA) is an iatrogenic disease derived from subcutaneous insulin formulations. The amyloid fibril protein is classified as amyloid insulin type, AIns, and the amyloid precursor protein is also identified as insulin.

The first account of LIDA in a human was in 1983. Since that time, many patient case reports have been published as well as review articles and laboratory analyses. In 1987, porcine insulin became the first foreign protein to become identified in human amyloid fibrils, a case that was discovered in a person with Type 1 diabetes where localized amyloidosis was found at the sites of insulin injection. Interestingly, this finding also established exogenous insulin as the first official case of iatrogenic amyloidosis. In the 1980's localized insulin-derived amyloidosis was inducted into the official nomenclature guidelines maintained by the International Society of Amyloidosis Nomenclature Committee. In a more recent study that was approved by the Mayo Foundation Institutional Review Board, localized insulin-derived amyloidosis was discovered in 50 people between January 2010 and May 2013—hardly suggestive of being an uncommon or rare occurrence.

 

Remarkably, the exact pathogenesis of LIDA remains unclear among the few that are aware of its existence within the medical and scientific communities.

Subcutaneous insulin formulations have historically been known for their poor stability. Rapid acting analogs, a form of subcutaneous insulin, have modified insulin's amino acid sequences to prevent the self assembly of insulin into hexamers and to favorably promote dissociation into monomers. Numerous additives are also included in subcutaneous insulin formulations, some of them known to be toxic: m-cresol and phenol, which could potentially in facilitating aggregation and/or denaturation of the insulin in the formulation. Another possible contributor for causing LIDA is the slow, erratic absorption that is common for subcutaneous insulins

Currently, this adverse reaction is not disclosed on insulin labels or by the FDA or ADA, despite it being a known complication since the 1980's.

 

Lack of awareness prevents people with diabetes and medical and scientific communities from knowing about LIDA in the first place. Knowing the clinical characteristics of LIDA, potential side effects and expected outcomes are not well established since LIDA has yet to be disclosed of to the medical community.

 

When considering the dearth of information on LIDA compared to the quantity of occurrences, the plausibility of LIDA being an uncommon or rare occurrence is highly unlikely.

LIDA is actually commonly misdiagnosed as lipohypertrophy, and goes under-reported due to a lack of label warning and consequently of awareness, education, diagnostic equipment and trained clinicians.

Diagnosis of AIns requires histopathological investigation, where Congo red staining is considered the gold standard for amyloid identification. Subtype identification is needed to identify the amyloid protein and many diagnostic methods can be used for this, such as: immunohistochemistry, Western blotting, mass spectrometry, immune-electron microscopy or amino acid sequence analysis (preferred).

 

Treatment for LIDA is surgical excision of the amyloid mass or the complete avoidance of insulin injections at or in close proximity to the mass. However, recent findings in a patient with diabetes who developed LIDA has revealed that the amyloid mass is capable of continued growth despite complete avoidance of insulin injections at the site of the mass.

 

It is highly plausible that LIDA is commonly misdiagnosed as lipohypertrophy due to the lack of awareness. diagnostic equipment and trained clinicians.

 

There is zero mention of LIDA on subcutaneous insulin labels, FDA website, ADA nor the Standards of Care. Awareness has been suppressed, attention manipulated and diverted to avoid disclosure of dangerous localized insulin-derived amyloidosis required by US law.

 

Evidence:

 

  1. Localized Amyloidosis at the Site of Repeated Insulin Injection in a Diabetic Patient

 

www.jstage.jst.go.jp/article/internalmedicine/49/5/49_5_397/_pdf

 

  1. Progressive insulin-derived amyloidosis in a patient with type 2 diabetes

 

www.ncbi.nlm.nih.gov/pmc/articles/PMC5095519/

 

  1. Insulin-derived Amyloidosis and Poor Glycemic Control: A Case Series

 

www.amjmed.com/article/S0002-9343(14)00035-7/fulltext

 

  1. Localized insulin-derived amyloidosis: A potential pitfall in the diagnosis of systemic amyloidosis by fat aspirate

 

onlinelibrary.wiley.com/doi/10.1002/ajh.23334/full

 

  1. Localized insulin-derived amyloidosis in patients with diabetes mellitus: a case report

Anonymous ID: db2b89 May 20, 2018, 12:14 p.m. No.1483320   🗄️.is 🔗kun

BIG PHARMA ACTION PROPOSAL

 

Prt 2

 

www.humanpathol.com/article/S0046-8177(09)00167-1/abstract

 

  1. Cutaneous amyloidosis at the site of insulin injection with coexistence of acanthosis nigricans

 

www.ijpmonline.org/article.asp?issn=0377-4929;year=2014;volume=57;issue=1;spage=127;epage=129;aulast=Nandeesh

 

  1. Insulin Derived Amyloidosis

 

www.ncbi.nlm.nih.gov/pmc/articles/PMC4287767/

 

  1. Ultrasonography Improves Glycemic Control by Detecting Insulin-Derived Localized Amyloidosis

 

www.umbjournal.org/article/S0301-5629(17)30279-X/pdf

 

  1. A Case of Insulin Resistance Secondary to Insulin Induced Localized Cutaneous Amyloidosis.

 

www.bloodjournal.org/content/114/22/4908?sso-checked=true

 

  1. Amyloidoma secondary to insulin injection: Cytologic diagnosis and pitfalls

 

www.ncbi.nlm.nih.gov/pmc/articles/PMC4527044/

 

  1. Localized insulin amyloidosis with use of a concentrated insulin: a potential complication

 

onlinelibrary.wiley.com/doi/10.1111/dme.13137/abstract

 

  1. Nodular amyloidosis at the sites of insulin injections

 

onlinelibrary.wiley.com/doi/10.1111/cup.12501/abstract

 

  1. Current insight in the localized insulin-derived amyloidosis (LIDA): clinico-pathological characteristics and differential diagnosis

 

www.sciencedirect.com/science/article/pii/S0344033817308750?via%3Dihub

 

  1. A Case of Type 1 Diabetes Mellitus with Marked Poor Glycemic Control caused by Insulin-derived Amyloidosis at the Site of Repeated Insulin Injections

 

www.jstage.jst.go.jp/article/tonyobyo/58/1/58_34/_article

 

  1. Coexistence of insulin-derived amyloidosis and an underlying acanthosis nigricans-like lesion at the site of insulin injection

 

onlinelibrary.wiley.com/doi/10.1111/j.1365-2230.2012.04373.x/abstract

 

  1. Localized insulin-dependent amyloidosis with scar tissue formation

 

www.jaad.org/article/S0190-9622(14)01680-6/pdf

 

  1. Iatrogenic, insulin-dependent, local amyloidosis.

 

www.ncbi.nlm.nih.gov/m/pubmed/6337294/

 

  1. Pharmaceutical amyloidosis associated with subcutaneous insulin and enfuvirtide administration

 

www.ncbi.nlm.nih.gov/pmc/articles/PMC4021035/

 

  1. The association between injected insulin and diffused cutaneous amyloidosis

 

www.mmh.org.tw/taitam/endoc/download/downpro-d04.doc

 

  1. Generating local amyloidosis in mice by the subcutaneous injection of human insulin amyloid fibrils

 

www.spandidos-publications.com/10.3892/etm.2014.1772

 

  1. AN ATYPICAL PRESENTATION OF INSULIN AMYLOIDOSIS: AN UNCOMMON BUT IMPORTANT COMPLICATION OF INSULIN THERAPY

 

journals.aace.com/doi/pdf/10.4158/EP171865.CR?code=aace-site

 

  1. Rapid degradation kinetics of amyloid fibrils under mild conditions by an archaeal chaperonin

 

www.ibbr.umd.edu/sites/default/files/event/Kyle%2520Anderson%252010-26-12.pdf

 

  1. Localized Subcutaneous Insulin-Derived Amyloidosis Excised after Evaluation Using Ultrasonography in a Patient with Type 2 Diabetes Mellitus

 

www.hindawi.com/journals/crie/2017/3985214/

 

  1. New Histologic Finding of Amyloid Insulin Bodies at an Insulin Injection Site in a Patient With Diabetes

 

www.ncbi.nlm.nih.gov/pubmed/29135508

 

  1. Human recombinant insulin and amyloidosis: an unexpected association

 

www.njmonline.nl/getpdf.php?id=905

 

  1. Nodular amyloidosis in a diabetic patient with frequent hypoglycemia: Sequelae of repeatedly injecting insulin without site rotation

 

www.jaad.org/article/S0190-9622(10)00257-4/pdf

 

  1. Insulin as an amyloid-fibril protein at sites of repeated insulin injections in a diabetic patient

 

link.springer.com/content/pdf/10.1007/BF00276849.pdf

 

  1. Amyloid fibril proteins and amyloidosis: chemical identification and clinical classification International Society of Amyloidosis 2016 Nomenclature Guidelines

 

www.tandfonline.com/doi/pdf/10.1080/13506129.2016.1257986

 

  1. FDAble Adverse Events Reporting System: Sample of Reports of Localized Insulin-Derived Amyloidosis

 

www.fdable.com/advanced_aers_query/2f3e5cb241c0f424780ea80a97540958

Anonymous ID: db2b89 May 20, 2018, 12:42 p.m. No.1483792   🗄️.is 🔗kun

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