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August 30, 2008
Polysorbate 80 and Histidine, a marriage of disaster
By Cynthia A. Janak
Do you know how it is when you have a gut feeling that just won’t quit? It is like the itch you just cannot scratch that gets worse with time. It is very annoying. Well, I was finally able to scratch that itch and all my efforts have finally paid off.
I have been researching Polysorbate 80 for some time now because I had a gut feeling that there is something to this chemical. I have been doing the same for Histidine because Gardasil is the first vaccine that is using this chemical. I knew that the addition of Histidine had something to do with what we are seeing with Gardasil. Here are my findings.
The Polysorbate 80 that is used in Gardasil is a product of Croda Chemicals, Inc. This information I received from a reliable source. The product names are Crills and Crillets. Here is a description of the product. Polysorbate 80 is listed as Crillet 4 Super a clear yellow liquid, (oil in water) O/W emulsifier and dispersant often used in conjunction with the appropriate Crill. Good solubilising properties, recommended in systems with unsaturated lipid components such as oleyl alcohol and vegetable triglycerides
Sorbitan esters and their ethoxylates
Crills and Crillets are a range of mild nonionic surfactants providing formulating benefits in a number of personal care applications. Entirely vegetable-derived, Croda’s Crills and Crillets have long-standing food and pharmacopoeia approvals and a safe history of use in cosmetic products.
Properties and functions
Crillets (Polysorbates) are excellent O/W emulsifiers, solubilisers, wetting agents and dispersants. In emulsion systems they are commonly used in combination with the corresponding Crill. Manipulation of the Crill/Crillet ratio produces emulsifying systems of various HLB (hydrophilic-lipophilic balance) values, allowing the emulsification of many cosmetic ingredients.
Health and safety
The Crills and Crillets are well-established raw materials used in a variety of applications. Certain sorbitan esters are accepted as food additives in Europe. Sorbitan esters are included in the FDA Inactive Ingredients guide. Polysorbates 60 and 80 are GRAS listed. (Generally recognized as safe.)
I found all this to be very interesting in the development of a vaccine. The reason being, that if you check out the Croda’s website you will find and Crill and Crillet are mainly used for personal items and cosmetics. I understand that it is also mentioned that it can be used in a variety of applications but I would think that they would mention vaccines or pharmaceutical uses as well. But that is neither here nor there.
What I want to bring to your attention is the fact that Polysorbate 80 is a surfactant. This is very important to remember.
sur•fac•tant (sər-făk’tənt, sûr’făk’-) n.
A surface-active substance.
A substance composed of lipoprotein that is secreted by the alveolar cells of the lung and serves to maintain the stability of pulmonary tissue by reducing the surface tension of fluids that coat the lung.
The term surfactant is a blend of “surface active agent.” Surfactants are usually organic compounds that are amphiphilic, meaning they contain both hydrophobic groups (their “tails”) and hydrophilic groups (their “heads”). Therefore, they are soluble in both organic solvents and water. The term surfactant was coined by Antara Products in 1950
My source also explained to me in layman’s language what all this means so I am going to impart that information to you. What this does is helps to suspend chemicals or materials evenly in the product that it is being used. In regards to a vaccine this helps to keep all the chemicals and virus like particles evenly distributed. This way one syringe will not have more chemicals and another will not have more virus like particles. You have more uniformity in the vaccine which is very important.
Another thing that I want to mention is that Polysorbate 80 is used in other products, such as Epoetin alpha (Eprex ®) and Darbopoetin alpha (Aranesp ®), which help stimulate the production of red blood cells in people suffering from anemia caused by cancer treatment.
Now let me bring to you some information about Histidine. (I do not endorse the product on this website.) http://www.cfsn.com/histidine.html
I was looking for a good explanation of Histidine. Most of the websites that I found were too technical and hard to understand. The above website has an easy to understand definition and that is the only reason that I am using it.
L-histidine* is an essential amino acid that cannot be formed by other nutrients, and must be in the diet to be available to the body.
Most often recognized as a precursor to the allergy symptom producing hormone histamine, both histidine and histamine have essential roles in the body beyond tormenting allergy sufferers.
Histamine is well known for its role in stimulating the inflammatory response of skin and mucous membranes such as those found in the nose — this action is essential in the protection of these barriers during infection.
Histamine also stimulates the secretion of the digestive enzyme gastrin. Without adequate histamine production healthy digestion can become impaired. Without adequate L-histidine stores, the body cannot maintain adequate histamine levels.
Less well known is that L-histidine is required by the body to regulate and utilize essential trace minerals such as copper, zinc, iron, manganese and molybdenum.
The addition of L-histidine in the vaccine Gardasil I believe was a bad idea. Here are my thoughts. You have girls that are suffering after receiving this vaccine and some of the symptoms are nausea, vomiting and irritable bowel. Without adequate histamine production healthy digestion can become impaired. This is the first clue in the puzzle that is besieging these families and doctors that are trying to deal with this new epidemic.
Another finding in the girls is that when a hair sample is tested they are finding high levels of metals present. Less well known is that L-histidine is required by the body to regulate and utilize essential trace minerals… Some of the girl’s symptoms are typical of metal poisoning such as: nausea, vomiting, diarrhea, stomach pain, headache, sweating… http://www.healthatoz.com/healthatoz/Atoz/common/standard/transform.jsp?requestURI=/healthatoz/Atoz/ency/heavy_metal_poisoning.jsp Use this site for a full description of Heavy Metal Poisoning.
There is another thing that is predominate with the girls is joint pain. I have found that low levels of histidine have been found in patients with rheumatoid arthritis.
A study of sera from 285 patients with definite or classical rheumatoid arthritis (including 37 patients receiving no anti-inflammatory drugs) and sera from 67 healthy subjects has confirmed 10 published reports of a statistically significant decreased blood histidine concentration in patients with rheumatoid arthritis.
So what is happening here? It is my opinion that low levels of histidine could be part of the overall problem that the girls are experiencing. Now my question to the medical research community is what could have caused this drop in histidine levels to cause all these problems?
I have my theory and that is that the immune response that was produced by the vaccine along with the infusion of histidine produced an unexpected reaction in all the girls that have a family history of allergies.
What happened is that because of this history it stands to reason that these girls already had a higher than normal level of histidine/histamine to begin with. Now we have just added more histidine into their systems therefore overloading and creating a dangerous situation. The immune system now has to deal with the dangerous levels of histidine along with the virus like particles and aluminum. Now we have a programmed immune response to the histidine and the immune system is going to attack it.
Another thing that L-histidine does is that it can pass through the placental wall to the fetus. This could be the direct cause to the spontaneous miscarriage and birth defects in some of the babies. Here is the MSDS (material safety data sheet) quote. Section 11: Toxicological Information, Special Remarks on Chronic Effects on Humans: Passes through the placental barrier in humans. http://www.sciencelab.com/xMSDS-L_Histidine-9927189
Now this is where it gets interesting. I am going to tell you about the marriage of Polysobate 80 a surfactant and histidine. This is one marriage that was doomed to failure from the start. Let me show you what I just found out a few days ago.
The title of this report is Surfactants Attenuate Gas Embolism-induced Thrombin Production.
Background: There are no pharmacologic strategies to prevent embolism bubble-induced blood clot formation. The authors conducted experiments to measure thrombin production in sheared whole blood in the presence and absence of bubbles and three surface-active compounds.
Fig. 1. (A) Fluorescence emission spectrum of Boc-VPR-MCA in the presence of thrombin. (B) Fluorescence emission spectrum of Boc-VPR-MCA in a sample of whole blood sheared at 100 s-1 for various durations. Excitation wavelength was 355 nm in all cases.
Fig. 2. (A) Continuous measurement of thrombin production induced by addition of histamine to whole blood. • = whole blood; ∇ = whole blood plus histamine. *P < 0.05 compared with the whole blood group (n = 3 per group). (B) Continuous measurement of platelet activation-mediated thrombin production induced by addition of adenosine diphosphate (ADP) in the presence of the three study surfactants. DCA = Dow Corning Antifoam 1510US; PF-127 = Pluronic F-127.
I was not familiar with the term Thrombin so I looked it up on MedicineNet.com. http://www.medterms.com/script/main/art.asp?articlekey=5764
Definition of Thrombin
Thrombin: A key clot promoter, thrombin is an enzyme that presides over the conversion of a substance called fibrinogen to fibrin, the right stuff for a clot.
Now back to this report. I was shocked when I read this paragraph of this report.
The time-dependent enhancement of thrombin production presented in figure 1B also appears in the data obtained using quiescent whole blood samples with and without exposure to histamine, as is depicted in figure 2A. Only means ± SDs of the peak fluorescence intensity data (emission wavelength, 460 nm) for each group at each time point are shown. The level of blood activation increased slightly more than 2-fold in the untreated quiescent sample after 30 min. In the histamine-treated sample, thrombin production increased more than 5-fold from the baseline value after 30 min. After the initial time point, significantly more thrombin was formed in the histamine-activated samples (P < 0.004 in all cases).
I want to make it perfectly clear that I am not a research scientist. I just present the facts as I find them and you are to make your own determination.
Now one of the things that we all know is that birth control pills can cause blood clots and anyone that is taking them should be aware of that fact. But were birth control pills the cause in some of the VAERS reports? I am no longer sure of that.
Now let us put this together with what I just gave you about surfactants and histamine you now have the possibility of a lethal, in my opinion, reaction of blood clots. According to the data that I have it proves to me that clotting does not necessarily happen because a girl is taking birth control pills during the time she received the Gardasil vaccination. This clotting has the real chance of happening because of the surfactant and histamine reaction in the body. Not because of the birth control.
I do not know how long it can take a blood clot to travel in the body. Nor do I know if this is the cause to the blood clots but it is pretty coincidental in my opinion. I think that Gardasil and this new relationship should be studied further before any more girls die or have a severe reaction to this vaccine.
One of the more severe side-effects that cannot be connected to the Gardasil vaccine is the MS like symptoms that some of the girls are experiencing. Doctors have not been able to find a cause to why this is happening and they are stumped but keep on doing research.
Now, as I said earlier I am not a research scientist and I can only base my opinion on what I know but I found something of great importance that further proves the causative factor of the infusion of L-Histidine in this vaccine.
I want to thank the Journal of Immunology for making the whole study available to the public.
A Key Regulatory Role for Histamine in Experimental Autoimmune Encephalomyelitis: Disease Exacerbation in Histidine Decarboxylase-Deficient Mice 
In this study, we used HDC-deficient (HDC–/–) mice, which are unable to synthesize histamine, to investigate the role of endogenous histamine in the development and progression of EAE. We report in this study that myelin oligodendrocyte glycoprotein- (MOG) 35–55-induced chronic EAE is more severe in a setting of profound histamine deficiency.
HDC — L-histidine decarboxylase
EAE — Experimental autoimmune encephalomyelitis
MOG — myelin oligodendrocyte glycoprotein
I read this whole study and it is hard to understand the procedures and the different tests that they conducted to come up with their conclusions. The one thing that I realized after reading it several times is that if you are depleted in your histamine production you have a good chance of having Encephalomyelitis symptoms which is an autoimmune disease.
Now I know that many people do not like the fact that I reference Wikipedia but I find it to be a good source of information especially with the sources are cited so I am going to use it now.
Encephalomyelitis is a general term for inflammation of the brain and spinal cord, describing a number of disorders:
acute disseminated encephalomyelitis or postinfectious encephalomyelitis, a demyelinating disease of the brain and spinal cord, possibly triggered by vaccination or viral infection;
encephalomyelitis disseminata, a synonym for multiple sclerosis;
equine encephalomyelitis, a potentially fatal mosquito-borne viral disease that infects horses and humans;
myalgic encephalomyelitis, a syndrome involving inflammation of the central nervous system with symptoms of muscle pain and fatigue; the term has sometimes been used interchangeably with chronic fatigue syndrome, though there is still controversy over the distinction.
experimental autoimmune encephalomyelitis (EAE), an animal model of brain inflammation.
 ^ Myalgic encephalomyelitis at NIH’s Office of Rare Diseases
I am bringing this one to your attention because of the symptoms noted which are muscle pain and fatigue. The girls are experiencing these symptoms along with many of the others that I have listed above. To further prove my point I did a search on Myalgic Encephalomyelitis and this is what I found.
Onset may be sudden and without apparent cause, for example a sudden attack of acute vertigo. There is usually a history of infection of the upper respiratory tract or, occasionally, the gastrointestinal tract. All cases have low grade pyrexia (up to 38 deg. C) usually subsiding within a week.
Subsequently, there is a persistent and profound fatigue, accompanied by a medley of symptoms such as headache, giddiness and a number of muscle symptoms such as pain, cramp, twitching, tenderness and weakness (especially after exercise). Other symptoms include paraesthesia (tingling, pricking, or numbness), frequency of micturition (urination), blurred vision and/or diplopia (double vision), hyperacusis (sometimes alternating with deafness or normal hearing) tinnitus, fainting attacks which may be the result of hypoglycaemia and a general sense of “feeling awful.”
Another symptom that is common with this vaccine is seizures. I found this study relevant to histidine/histamine. http://lib.bioinfo.pl/pmid:15179676
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2004 May ;33:197-200 15179676 (P,S,E,B)
[Effect of alahistidine on brain histamine content and seizure development]
Wei-wei Hu, Zhong Chen, Li-sha Xu, Chun-lei Jin, Eiko Sakurai, Kazuhiko Yanai
OBJECTIVE: To investigate the effect of alahistidine on brain histamine content and seizure development. METHODS: The kindling seizure was induced by ip injection with subconvulsant dose of pentylenetetrazole every 48 h. Monoamines and their metabolites were measured using a HPLC system and fluorometric assay. RESULT: Chronic low histamine feeding markedly decreased histamine content in cortex and hypothalamus, and promoted seizure development induced by pentylenetetrazole. However, alahistidine feed reversed the decreased histamine content and slowed seizure development caused by low histamine feed. Both low histamine and alahistidine feed had no effect on norepinephrine, dopamine and its metabolites. CONCLUSION: Alahistidine may affect histaminergic system and seizure development.
NOTE: I was not able to access the full study because a subscription was needed.
Look at all this. I mean really look at this. We have the same symptoms that the girls are going through. How much more can I give to prove that we have the causative factor involved with this new epidemic we are experiencing with this vaccine.
How long is it going to take the FDA and the CDC and all the other organizations around the world to see what is happening here? We already have 9,749 reported adverse events and 21 reported deaths in the United States alone. Do we need to make that number go into the 100,000’s? What do they need?
I am begging the FDA, CDC and Merck to please please look at my findings. I am not a research scientist but I was the one to have to put the pieces of this epidemic together for you. Check out the dates of the studies that I have referenced. This information was available pre-licensure of Gardasil. Find out who was asleep at the switch to let all these findings be ignored.
Why did I have to be the one? Why were not these chemicals studied in a setting to see what they would do in a vaccine environment? WHY, WHY, WHY!!!!!!!!! We have girls dying and disabled and you are saying that there is no causative factor with Gardasil. Here it is! All the causation you need. Look into this immediately.
Oh, my dear God. I am sorry but I have to end this article here because I am next to tears and cannot go any further.
Please do your own research into this vaccine and decide if it is the right thing for you.
NOTE: If I have made any mistakes because I am not a research scientist with what I have posted here today please feel free to let me know and I will check out your findings and post a retraction.
 Anesthesiology:Volume 100(1)January 2004pp 77-84
Surfactants Attenuate Gas Embolism-induced Thrombin Production
Eckmann, David M. Ph.D., M.D.*; Diamond, Scott L. Ph.D.†
* Associate Professor, Department of Anesthesia and the Institute for Medicine and Engineering; † Professor, Department of Chemical Engineering and the Institute for Medicine and Engineering.
Received from the Department of Anesthesia, University of Pennsylvania, Philadelphia, Pennsylvania.
Submitted for publication June 16, 2003.
Accepted for publication August 25, 2003.
Supported by grant No. R01 HL-67986 from the National Heart, Lung and Blood Institute, Bethesda, Maryland, and the Department of Anesthesia, University of Pennsylvania.
Presented in part at the 4th World Congress of Biomechanics, Calgary, Alberta, Canada, August 6, 2002.
Address reprint requests to Dr. Eckmann: Department of Anesthesia, University of Pennsylvania, 3400 Spruce Street, Philadelphia, Pennsylvania 19104. Address electronic mail to: firstname.lastname@example.org. Individual article reprints may be purchased through the Journal Web site, http://www.anesthesiology.org .
 The Journal of Immunology, 2006, 176: 17-26.
Copyright © 2006 by The American Association of Immunologists
A Key Regulatory Role for Histamine in Experimental Autoimmune Encephalomyelitis: Disease Exacerbation in Histidine Decarboxylase-Deficient Mice1
Silvia Musio*, Barbara Gallo*, Stefano Scabeni*, Marilena Lapilla*, Pietro L. Poliani , Giuseppe Matarese , Hiroshi Ohtsu , Stephen J. Galli¶,#, Renato Mantegazza*, Lawrence Steinman||,# and Rosetta Pedotti2,*
* Immunology and Muscular Pathology Unit, National Neurological Institute “C. Besta,” Milan, Italy; Department of Pathology, University of Brescia Medical School, Brescia, Italy; Gruppo di ImmunoEndocrinologia, Istituto di Endocrinologia e Oncologia Sperimentale, Consiglio Nazionale delle Ricerche, Napoli, Italy; Applied Quantum Medical Engineering, Graduate School of Engineering, Tohoku University, Sendai, Japan; and ¶ Department of Pathology, || Department of Neurology and Neurological Sciences, and # Interdepartmental Program in Immunology, Stanford University, Stanford, CA 94305
Received for publication April 12, 2005. Accepted for publication August 2, 2005.
 A. Melvin Ramsay. Myalgic Encephalomyelitis and Postviral Fatigue States: The Sage of Royal Free disease. 2nd edition. Gower Medical Publishing, London 1988.
Note: this fair summary of Ramsay’s 1988 description is taken from the National Task Force Report, 1994.
© Cynthia A. Janak
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