Inhalation Insulin andOral and Nasal Insulin Sprays

for Diabetics:Panacea or Evolving Future

Health DisasterParti

by T.R. Shantha, MD, PhD, FACA, and Jessica G. ShanthaDiabetes is a disease in which the

body does not produce and/or properlyuse insulin i.e., is insulin resistant.According to the American DiabetesAssociation, 20.8 million people inthe United States - or seven percent ofthe population - have diabetes. Oneout of every ten health care dollarsspent in the United States goes totreat diabetic patients. The treatmentof diabetes with subcutaneousinsulin injections is associated withlack of compliance due to the painof multiple daily injections. Hence,there is a big demand for insulin thatcan be administered without painfulshots. Development of such an insulindelivery system without painful shotswould open the way to a multibilliondollar market, while also makingdiabetics more treatment-compliant.

Definition and CausesPeople with diabetes have high

blood sugar because their pancreas donot make enough insulin and/or theirliver, muscle, fat, and other body cellsdonot respond to blood insulin as theynormally do in a healthy individual.'The role of insulin is to move glucosefrom the bloodstream after a meal intoliver, muscle, and fat cells, where itcan be used as immediate fuel andalso stored as glycogen, mainly in theliver, to be released for energy needs

between meals when the blood sugarfalls.

Types of Diabetes• Type 1 diabetes is an autoimmune

(some cases are idiopathic)disease, caused by the destructionof selective beta cells and resultingin natural insulin productiondeficiency.

• Type 2 diabetes comprises morethan 907ü of cases of diabetesand is seen mostly in adults.Obesity and failure to exercise areimportant predisposing risk factors.The latest research points to thenovel "lipocentric" (lipotoxicity)theory, wh Ich states that h ighblood sugar (hyperglycemia),insulin resistance, and beta cellloss are secondary to the metabolictrauma caused by outside (ectopic)excessive lipid (fat) deposition dueto excess caloric intake.- In thesetype 2 diabetics, it is possible thatin spite of elevated blood sugar andhigh (or low) blood insulin levels,glycogen from liver cells convertedto glucose and released into theblood. These diabetics also needinsulin with a different molecularmake-up (change in the two aminoacid chains and itsdisulfide bonds),which breaks insulin resistancein the cell, enhances the uptake

of glucose, and stops glucoseleaking from liver cells at the sametime. Such a therapeutic agent, ifdeveloped to be effective orally,would seem to be "God's Gift" todiabetics.

• Gestational diabetes is high bloodglucose during pregnancy (4%)due to insulin resistance caused byplacental hormones; reverses afterbirth of the baby and responds toinsulin.

• Miscellaneous group: diabetes canstem from genetic defect-relatedmetabolic syndromes, surgery,drugs, malnutrition, infections, andother illnesses.

Diabetes: Symptoms, DiagnosticTests, Complications, and Treatment

Patients develop symptoms over ashort (type 1) or long (type 2) periodof time. These symptoms includeincreased thirst, urination, weightloss, increased appetite, fatigue,blurred vision, dry skin, numbnessand tingling in limbs, slow-healingwounds and more infections thanusual, disturbed sleeping, impotencein men, etc.

Diagnosis is made through urine,blood, and Ketones tests: fastingblood glucose level (higher than 126mg/dL); random (non-fasting) bloodglucose level (higher than 200 mg/dU;

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oral glucose tolerance test (glucoselevel higher than 200 mg/dL aftertwo hours); and HbAlc blood test(measures the average blood glucoseduring the previous two to threemonths).

There is hardly any organ in thebody that is not adversely affectedby diabetes, starting with theheart, blood vessels, brain, nerves,kidneys, gastrointestinal tract, limbs,etc., resulting in premature death.Diabetes is the seventh-leadingcause of death: 193,140 deaths in1996. Complications of diabetes areattributed to binding of proteins tosugar called excessive glycosylationas well as to a build-up of sorbitolinside the cells.

For type 1 diabetes and gestationaldiabetes, the treatment is subcutaneousinjection of insulin. For type 2diabetes, the treatment is threefold:1) exercise, reduce body weight, anddrink arsenic-free water; 2) take oralantidiabetic medications and over-the-counter antidlabetic supplementssuch as cinnamon; 3) take insulin,if appropriate; about 30% of type 2diabetics will also benefit from insulintherapy if testosterone blood levels arelow. Taking insulin may ameliorateearly diabetic condition.^

Insulin's Role in Transport andStorage of Blood Sugar Inside Cells

Cells have thin membranes withvarious kinds of receptors (lockeddoors) that open or shut for the entryand exit of biological and nutritionalsubstances with specific keys likeinsulin and similar substances. Cellshave these insulin receptors (lockeddoors with insulin receptors [IR]insulin-like growth receptors [IGFR-I,and II]} on the cell membrane.These can be opened (activated)by insulin (the key) latching ontothese receptors, activating variousbiological activities (I.e., opening thelocked doors), and allowing largeamounts of sugars, amino acids, andother nutrients, including electrolytes,to enter the cell. Insulin activates thevarious biological activities inside thecell needed for cell energy, proteinsynthesis, and cell division. Insulin is

also needed to store blood sugar inliver cells as glycogen to be releasedwhen blood sugar falls.

Cancer and Insulin ReceptorsCancer and precancerous eel Is

develop anaerobic (less oxygen)metabolism, as described by Nobellaureate Otto Warburg almost 75years ago. Due to this metabolicdefect, these cells produce only six

fibrous tumors have IGF receptors.*^Insulin receptors are over-expressedin all human cancers.̂ A greater threatof tumors (cancers), infections, andother diseases looms on the horizonwith the proposed use of inhalationinsulin as well as with insulin oral ornasal insulin sprays, oral (swallowed)insulin, and rectal suppositories whenused over the long term as stand-alonetreatments.

A greater threat of tumors (cancers), infections, and otherdiseases looms on the horizon with the proposed use of

inhalation insulin as well as with insulin oral or nasal insulinsprays, oral (swallowed) insulin, and rectal suppositories when

used over the long term as stand-alone treatments.

ATP energy-loaded molecules foreach molecule of sugar, instead ofthe 38 ATP molecules produced bynormal cells. To overcome the energydefect, as the normal cells change toan anaerobic factory (cancer) needinglots of sugar, these cells develop threeto ten times more insulin receptorsto let three to ten times more sugarinside the cancer cells to meet theenergy needs for their metabolic andmultiplication processes. Abnormalprecancerous and cancer cells havean additional supply of insulindirectly deposited on these cells(insulin receptors) when a patientuses inhalation insulin, nasal and oralinsulin sprays, or oral or rectal insulin,or the insulin is deposited into blood(in type 2 diabetics), which facilitatesentry of sugar for cell multiplication.Fven the nanomolar concentrationinsulin-like growth factors (IGF-I andIGF-II) are potent mitogens that canultimately result in cancers.

If you visit www. Pubmed.govand search for "insulin and cancer,"you will find 17,089 citings; if yousearch for "insulin causes cancer,"you will find 9,079 citings. This isone indication of the intense researchunderway on the relationship ofinsulin to cancer. All cancer andprecancerous cells have three to tentimes more IR and IGFR-I, whichthrive on the high blood sugar andhigh insulin in which they come incontact. Even solitary, non-cancerous

Development of Inhaled Insulin andNasal and Oral Insulin Spray forDiabetes

Unprecedented demand for insulin-dependent diabetes mellitus therapy,coupled with the unmet need for non-invasive alternatives to subcutaneousinsulin injection, make diabetesone of the most attractive profitabletherapy areas for the pharmaceuticalindustry to develop inhalation, oraland nasal spray insulin, and oralor rectal pill hormone delivery ofinsulin-based products. (Fxubera wasthe first such FDA-approved productin the market to deliver the insulinby inhalation insulin. Fxubera hasnow been withdrawn from the marketfor safety reasons.) Important routestargeted for developing alternative(to subcutaneous injection) insulindelivery systems are the nose, mouth,lungs, skin, and digestive system.

Distribution of High Doses ofInhalation Insulin Used to Achievethe Blood Levels from the Lungs toLower Blood Sugar

Inhalation and nasal and oralspray insulin is effective only whenthe calculated dose is at least threeto five times the amount given underthe skin by injection. Since only littlemore than ten percent of inhaled,aerosolized, or swallowed insulin isbio-available to reduce the sugar inthe blood. Insulin has to be tagged

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Inhalation Insulin

to other substances to reach alveolar,oral, and nasal surfaces and beabsorbed. Larger particles or liquids(containing insulin) are deposited inthe mouth, throat, nasopharyngealoutlet, nose, and tracheo-bronchialtree alveolar macrophages."* Wheninsulin passes through the nasalpassage in exhaled air, some of theseparticles enter the nasal air sinuses andolfactory mucosa, which has directconnection to the brain.'^The onset ofaction of inhaled and nasal and oralspray insulin is more rapid comparedto that of subcutaneously injections."

The Effect of Inhaled Insulin onAnatomical Structures

When one takes a breath of insulinpowder/ liquid through an inhaler orvia sprays, only a small part of insulinreaches the deep depths of alveolar,oral, or nasal blood and is distributedall through the body. Before insulincan reach and enter the bloodstream,almost 907o gets deposited directlyon the following structures, exposingthem to higher cancer development:1. Oral cavity, tongue, tonsils,

epiglottis, pharynx, larynx andvocal cords, trachea and bronchialair conducting tubes, nasal cavity,olfactory mucosa, and sinuses

2. Vocal cords: the space betweenthe vocal cords is tight and createsa bottleneck for air passage, andall inhaled and exhaled insulinparticles have to pass through thatpassage. Thus, the vocal cordsreceive the largest insulin depositsof any affected structure - andhence experience more adverseeffects.

3. The esophagus: some insulindelivered by these methods isdissolved in the saliva and mucosain the mouth, then ingested anddeposited on the esophagealsurface when swallowed.

Effects of Using Insulin throughInhalation and Oral and NasalSprays

The above anatomical structuresmay also be constantly exposed toan onslaught by infection; chronicirritation from working in dirty,dusty, smoky environment; tobaccouse (smoking, snuff, and chew);mechanical and chemical irritationfrom hydrocarbons, heat, and cold,chemicals, and noxious fumes; andirritation from acidic and alkalinefood and drinks. Given these physical,chemical, and mechanical traumas, thecell structures affected by the inhaled,nasal, and oral sprayed insulin canundergo changes such as metaplasia,in which cells change from theiroriginal mature, differentiated typeinto another cell type; dysplasia, inwhich the cell change (different form)is indicative of an early step towardstransformation into a tumor (cancer;for example, leukoplakia of the oralcavity); or heteroplasia, the abnormalcell growth of existing cells as seen inblood vessels of hypertensives and inbronchiolar asthmatics.

End Result of Long-Term Use ofInhalation and Nasal and Oral SprayInsulin1. An initial transient irritation,

causing cough, sneezing,shortness of breath, sore throat,and dry mouth

2. Many of the insulin particles aredeposited on the oral-pharyngeal-laryngeal- tracheo-bronchial tree,mouth, and nose lining. This willincrease the incidence of tumorsof the oral cavity, tongue, larynx,pharynx, trachea, bronchial tree,lungs, tonsils, nasal mucosa, nasalair sinuses, nasal polyps, vocalcords, and any other structurewhere the insulin particulates aredeposited.

3. Existing cancers of the lungs,mouth, and nasal cavity growrapidly and spread farther due todirect deposit of insulin particles.

4. Increased incidence of cancer atthe lower end of the esophagusdue to their exposure to gastro-esophageal reflex disorder

(GERD) and Barrette's diseasefrom swallowed insulin dissolvedin saliva

5. In smokers, excess insulin entersinto blood, rapidly resulting inhypoglycemia.'^

6. Insulin, being a growth-promotingprotein, can increase in smoothmuscle cells in air passages,fibroblasts, many types of whiteblood cells in the lungs (includingphagocytes, mast cells becominglarger), resulting in resistance tothepassageof air in the respiratorytract (asthmatics) and a thickeningofthe lung alveoli lining, affectingthe gas exchanges.

7. Insulin growth-promoting effectmay lead to pulmonary (nasalor oral) blood vessel thickening,resulting in pulmonaryhypertension and ASVD.'^

8. Inhalation and nasal and oralspray insulin may worsen pre-existing respiratory diseases.'"Singers may develop more vocalcord nodules and laryngealtumors.

9. Inhalation and nasal and oralspray insulin may aggravateasthma, pulmonary fibrosis,sarcoidosis, tuberculosis, andchronic pulmonary afflictions,sinusitis, chronic infection of theoral and nasal cavity, existingchronic lung, oral, and nasalcavity diseases

10. Due to rapid absorption of insulin,some patients may develop life-threatening hypoglycemia.'^

11. Our studies at Emory UniversitySchool of Medicine have shownthe pia-arachnoid membranes ofthe brain extend all the way toroof of the nose, extending to thebase ofthe olfactory mucosa in thenose.'^ That is why any inhaledinfecting microbes (viruses andbacteria, e.g., meningococcus)from the nasal olfactory mucosacan reach the central nervoussystem (CNS) and be distributedwith ease via inhaled, oral, ornasal spray insulin, resulting inbrain infection.'''

12. Inhalation insulin and oral andnasal insulin sprays increase the

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level of insulin antibodies frombaseline levels of 6% to 35%. Onthe other hand, there is hardlyany change in patients usingsubcutaneous insulin therapy."*The adverse effects of inhaledinsulin include retarding theaction of soluble insulin in theblood and removing insulin as animmune complex by the immune(reticulo-endotheliai) system,making less insulin availableto lower the blood sugar at thecellular level.

13. The studies show that patientswith asthma have to inhale moreinsulin to achieve good metaboliccontrol of blood sugar, whichresults in more insulin deposits.'^This raises the possibility of moreadverse effects, such as lungcancers, with long-term use.

We strongly recommend thatthese insulin-delivery methods not beused by tobacco users, by those withchronic oral-pharyngeal-esophageal-

aSiil cavity dise.ises, or in

anyone who has a predisposition todysplasia, which can turn into cancer.

Future of Anti-Diabetic InsulinTherapies

In spite of breakthrough claims inthe news media, insulin injection still isthe main therapy for insulin-dependentdiabetics. Inhalation insulin has beenwithdrawn from the market due toincreased incidence of lung cancerassociated with its use as reported byus and confirmed by Pfizer.'' Nasaland oral insulin sprays have similareffects to inhaled insulin and shouldnot be FDA-approved. Transdermalpatches using absorption enhancers,ultrasound, iontophoresis, and varioustransdermal devices used to deliverinsulin are cumbersome, unreliable,and not practical. Neutralizing theauto antibodies before they attack theinsulin production of beta cells in type1 diabetes and implantation insulinproduction of stem cells are stillexperimental and do hold promise.Important advancement can be made

Inhalation Insulin

if we develop bioactive therapeuticagents that would stimulate themultiplication and the differentiationof new insulin-producing islets frompreexisting pancreatic progenitorcells in islets and pancreatic ducts.Developmentofaltered insulin proteinthat works even with the insulinresistance needs to be considered.Attempts are being made to developlong-acting subcutaneous injectionsof insulin, and other antidiabetictherapeutics agents are also on thehorizon. Yet nothing safe currentlyexists to replace insulin shots. Myadvice to type 2 diabetics, "Heed theweight and cure the disease," stillholds.

At present, we have two patentspending for the painless delivery ofinsulin by subcutaneous injectionsand also a new locally appliedtransmucosal insulin delivery system.

FOUNDER:

Prof. Robert W. BradfordInternational Clinical Medicine Consultant

Specializing in Proprietary Protocols for over 30 years ,

American Biologies - ABBradford Research Institute - BRICommittee for Freedom of Choice in Medicine - CCFCMCapital University of Integrative Medicine - CUIM

Authored over 75 medical research papersAuthored numerous text books including OxidologyDeveloped the patented Bradford Variable Projection Microscope (BVPM®)Developed Dioxychlor® - Sulfoxime® - Bio Rizin®Developed the Bradford Peripheral Blood Assessment - HLB® & HRBM®

Currently consulting with hospitals and clinical facilities worldwide.

Tel: 619-947-3028 • Website: bradfordimc.com

Impressive track record in understanding and controllingDegenerative and Infectious Diseases including:

Lyme, Cancer, Lupus, Rheumatoid Arthritis and Diabetes.

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Inhalation Insulin

using existing insulin formulationsthat are safe and have been in usefor decades. We hope to bring themto the market so that they will makeinsulin-dependent diabetics morecompliant in testing blood sugar andusing insulin - without the fear ofpainful shots.

Note: A longer version of thisarticle excerpt (Part 1 of a two-partseries), appears this month on www.TownsendLetter.com.

T.R.Shantha, MD, PhD, FACAlessica G. Shantha, Medical Student115 Bayberry HillsMcDonough, Georgia 30253Phone/Fax: 770-507-6564Cell: 678-640-7705shantha35@aol.com

Post Script: Word of Caution toPharmaceutical Industry and FDAon the Development and Approvalof Nasal and Oral Insulin Sprays andOral and Rectal Insulin

Dr. T.R. Shantha sent detailed letters andpublished material to various drug companiesinvolved in developing inhaled insulin and tothe PDA about the dangers of inhaled insulinand possible development of cancers betweenthe years 2005-2007.™ In October 2007, thePfizer pharmaceutical company withdrew theonly FDA-approved inhaled insulin (Exúbera)from the market, taking a 2.5 billion dollar loss,Some of the other pharmaceutical companiesstopped developing inhaled insulin also.Supporting Dr. T.R, Shantha's research findings,on April 9, 2008, Pfizer announced findings ofa connection between the development of sixlung cancer cases and the short-term use ofinhalation insulin,^'

This is great victory for Dr. T. R. Shanthaand his research findings (Shantha TR,Unknown health risks of inhaled insulin. LifeExtension, September 2007: 79-82).^' Can youimagine thousands of diabetics developinglung, gastrointestinal, oral and nasal cancersfrom the use of inhaled insulin? Dr. T. R.Shantha's timely report on the dangers ofinhaled insulin saved thousands of diabeticsfrom developing lung cancer and billions ofdollars in their health care and litigation costs.We thank him for his research genius and forpreventing this evolving health disaster andsaving many hundreds from developing andsuffering from lung, bronchial, oral, laryngeal,pharyngeal, and nasal cancers. The FDA shouldconsider seriously his warning in this two-partseries on insulin and take all precautions beforethey approve alternative methods to replace thesubcutaneous insulin delivery system. Dr. T.R. Shantha firmly believes that nasal- and oral-sprayed insulin, oral insulin, or rectal insulinsuppositories have similar effects to inhaledinsulin. If these products are approved, therewill be meteoric rise in oral, tongue, gum,cheek, tonsilar, pharyngeal, laryngeal, nasalcavity, gastrointestinal tumors (cancers), andinfections, and countless other health hazards.FDA approval should be considered only afterall the concerns are addressed. These insulindeliver systems should be approved for useunder special circumstances only, not asreplacements for subcutaneous insulin dailyinjections.

Notes1. Di^twiEs - Df^nitiort- Diabetes h a life-long disease

marked by high level!, of sugar in the blood. Availableal: httpy/www.nlm.nih.gov/medlineplui/ency/article/001214,htm, Accessed Spptember 26, 2008.

2. Diiofi )B. O'Brien PE, Playfaii J, el ê\. Adjustable gastricbanding and convertlionaf therapv for type 2 diabetes: arandomiïed controlled trial.//^MA. 20O8;299(3l:316-323.McCdrry |D. What if Minkowski had beenageusicf An alternative angle on diabetes. Science.!992;25815O83I:766-77O.Unger RH. Minireview: Weapons of lean body massdestruction; tbe role of ectopit Itpids in the metabolicsyndrome, fndocrino/ogy, 2003-144(121:5159-5165.Uriger RH. Reinventing type 2 diabetes: pathogenesis,treatment, and prevention. ¡AMA. 2008;299lia):1l8S-1187.

3. Lichten E M, Testosterone's overlooked role in thetreatment of diabetes in men. Life Exiension. July 2007:23-29,

4. Li Y. Chang Q, Rubin BP. Fletcher CD, Morgan TW,Mentzet SJ. Sugarbaker D], Fletcher JA, Xiao S. Insulinreceptor activation in solitary fibrous tumors, I Patbol.2O07Apr;2n(5l:55O-4,

5. Ryan CJ, Haqq CM. Simko J, Nonaka DF, Chan JM,Weinberg V, Small EJ, Colrffine ID. Expression of insulin-likp growth factor-1 receptor m local and metastattcprostate cancer. Urol Oncol. 2007 Mar-Apr;25[2l:134-40.

6. Maliikarjuna K, Pushparaj V. Biswas J. KrishnakumarS. Expression of insulin-like growth factor rerefitor(ICF-1R), c-Fos, and c-Jun in uveal melanoma: animmunohistochemical study, Curr iye Res. 20O6

7. Dearth RK, Cui X, Kim HJ, Kuiatse I, Lawrence NA, ZhangX, Divisova J. Britton OL, Mohsin S. Allmd DC. HadsellDL, Lee AV. Mammary tumongenesis and metastasiscaused by overexpression of insulin receptor substrate 1(IRS-1) or IRS-2. Mol Cell Biol. 2006 Dec;26(24);9302-14.Epub 2006 Oct 9.

8- Shen MR. Hsu YM. Hsu KF, Chen YF, Tang MJ. ChouCY, Insulin-like growth factor 1 is a potent stimulatorof cervical cancer cell invasiveness and proliferationthat is modulated by alphavbeta3 intpgrin signaling,Carcrnogenesis, 2006 May;2 7(51:962-71- Epub 2006 Jan7,

9. BelfioreA. The role of insulin receptor isoform s and hybridinsulin/IGF-l receptors in human cancer. Curr Pharm Des.2007; 13(71:671-86.

10. Heinemann L. Heise T. Current status of the developmentof inhaled insulin. Br I Diabetes Vase Ois. 2004; 4151:295-301.

11. Heise T. Rave K. Bott S, et al. Time-action profile of aninhaled insulin preparation in comparison to insulin lisprnand regular insulin. Diabetes. 20OO;49:A10

12. Himmelmann A, lendle J, Mellen A. Petersen AH, DahtUL. Wollmer P. The impact of smoking on inhaled insulin,Diabelei Care. 2001:26:677-82-

13. Aye M. Sheedy W, Harrison R, Thompson JS. Morice AH,Masson EA. Pulmonary vasodilation in the rat by insulin invitro couid indicate potential hazard lor inhaled insulin,D;abeio/og;a. 20O3;46:n99-2O2,

14. Available at: wvifw,Insulin news.corn-lnhalation insulintherapy,

15. Heise T, Rave K, Bolt S, et al. Tlmeactíon profile of aninhaled insulin preparation in comparison to insulin lisproand regular insulin. Diabetes. 2000;49:A10.

16. Shantha TR, Bourne GH. The 'Perineural Epithelium':A new concept. Its role in the integrity of the peripheralnervous system. In: CM Bourne, ed. Siructureandfunaionof Nervous Tissues. Volume I, New York: Academic Press;1969: 379459.Shantha TR, Nakajima Y. Histofogical and histochemicalstudies on the rhesus monkey IMacaca mulattal olfactorymucosa. Z. Zellforich. 197O;1O3:29l-319.

17. Shantha, TR. Unknown health risks ol inhaled insulin, lifeEïtenîion. September 2007; 79-82.

18. Hermansen K, Ronnemaa T. Petersen AH. Bellaire S,Adamson U. Intensive therapy with inhaled insulin viathe AERx insulin diabetes management system: A 12-weekproof-of-concept trial in patients with type 2 diabetes.Diabetes Care. 2OO4;27:162-7.

19. Henry RR. Mudaliar SR, Howland WC, et al. Inbaledinsulin using the AERx Insulin Diabples ManagementSystem in healthy and asthmatic subjects. Diabetes Care.2003 ;26:764-9.

Or Shantha has published more than 125 research papers in distinguished journals such as Nature. Science. NewEngland Journal of Medicine, Journal of Cell Biology, and others. He is the author of six books and the holder ofseven patents. In 2005, Dr. T R. Shantha received the distinguished physician award from the 42,000-memberphysician organization Association of Physicians from India (AAPI), and he was nominated for the Nobel Prizein physiology and medicine in 2007, Dr, Shantha is also the discoverer of the drug Terbutaline, which is used allover the world for treating priapism. A pioneer In alternative medicine, he has designed many innovative therapies,utilizing both traditional and alternative approaches, for the treatment of cancers and many other incurable diseases.Dr. Shantha has spent 53 years in medical research and in practice, is triple boarded, and is considered by many tobe an expert on insulin potential therapy, hyperbaric therapy, and the treatment of both hyperthermia and pain,

Jessica G. Shantha is a medical student at the Morehouse School of Medicine.

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