Excerpts from the Transcript of the CDC’s Private Simpsonwood Meeting

First things first: What was the Simpsonwood Meeting and why should you care about reading excerpts from it?

July 7, 1999, the American Academy of Pediatrics and the Public Health Service issued a joint statement which provides the background for the private CDC meeting that would occur the next year. Keep these statements in mind when reading the excerpts from Simpsonwood. Once you have read them, ask yourself if you are inclined to agree with the last two statements in particular.

The Food and Drug Administration (FDA) Modernization Act of 1997 called for FDA to review and assess the risk of all mercury-containing food and drugs. In line with this review, U.S. vaccine manufacturers responded to a December 1998 and April 1999 FDA request to provide more detailed information about the thimerosal content of their preparations that include this compound as a preservative. Thimerosal has been used as an additive to biologics and vaccines since the 1930s…”

…there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule.” (emphasis mine)

The recognition that some children could be exposed to a cumulative level of mercury over the first 6 months of life that exceeds one of the federal guidelines on methyl mercury now requires a weighing of two different types of risks when vaccinating infants. On the one hand, there is the known serious risk of diseases and deaths caused by failure to immunize our infants against vaccine-preventable infectious diseases; on the other, there is the unknown and probably much smaller risk, if any, of neurodevelopmental effects posed by exposure to thimerosal. The large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thimerosal-containing vaccines over the first 6 months of life.” (emphasis mine)

(As an aside #1- how exactly does one make a definitive public statement that the “large risks of not vaccinating children far outweigh” (fill in the blank comparative risk) when in the very next breath one describes said comparative risk as “unknown” and “probably much smaller”?)

Just shy of one year later, June 7th and 8th of 2000, the CDC convened a group of experts to discuss the issues. This meeting is briefly mentioned, although not by name, in the CDC’s Timeline: Thimerosal in Vaccines (1999-2010):

“Fifty-one vaccine and vaccine safety researchers and experts meet in Atlanta, GA to review data regarding thimerosal in vaccines and nervous system disorders. A report summarizing the meeting was presented to ACIP.”

The primary focus of the private discussion was this study led by Thomas Verstraeten: increased risk of neurologic impairment after high-exposure to thimerosal containing vaccine in first month of life. Age of Autism summarizes of Verstraeten’s study in a Special Report linked below:

“This study, conducted by investigators at the CDC using the Vaccine Safety Datalink (VSD) of computerized HMO databases was a two-part ‘retrospective cohort study.’ The first phase looked at potential associations between neurodevelopmental disorders (NDDs) – including autism, ADD, speech and language delay and tics – and thimerosal among 124,170 US children born from 1992 to 1999 at one of two HMOs (A and B)…”

It is very important that you view this unpublished abstract of the first version of the study because these are the data the researchers are responding to. By the time the study was finally published in 2003 it had undergone multiple additional analyses, with each analysis getting closer to conclusions deemed acceptable. The following are the relative rates of increased risk to children exposed to greater than 25 mcg of thimerosal according to the original study:

ADHD: 11.35 times more likely

autism: 7.62 times more likely

ADD: 6.38 times more likely

Tics: 5.65 times more likely

Speech and language delay: 2.08 times more likely

(As an aside #2: This study alone invalidates the 2nd claim excerpted from the AAP and PHS joint statement above. If there were no data, Verstraeten would have had nothing to compile. If what he compiled was not taken seriously, surely the CDC would not have bothered to hold a private meeting of 51 experts to discuss it.)

For frame of reference, Robert F. Kennedy Jr famously points out that the relative risk for smoking a pack of cigarettes a day and getting lung cancer is 10. Of course, cigarettes come with a Surgeon General’s warning on every pack, but I digress…

(As an aside #3: it is outside the scope of this article to discuss the issues of how and why the subsequent analyses of this study concluded with results that are far more favorably suited for public vaccine policy. Those interested in a very detailed discussion of that issue may refer to Age of Autism’s Special Report: Vaccines and Autism- What do Epidemiological Studies Really Tell Us? Verstraeten’s study is discussed at length along with several others.)

The Simpsonwood Transcript was uploaded in a 259 page pdf by the group Safeminds.org. Safeminds obtained the transcript of this meeting along with subsequent private correspondence between some of the researchers via a FOIA (Freedom of Information Act) request. Some very illuminating comments from this correspondence are included in the Age of Autism Special Report linked above, in the section on Verstraeten’s study.

Thimerosal was mostly removed from vaccines in 2001. How is this discussion relevant today? These excerpts are an irrefutable example of the disparity between the CDC’s often definitive, “science is settled” type statements (which essentially amount to public relations blurbs) found in their superficial, front page, pediatrician’s office summarized info sheet- type information versus the data discussed privately among their experts. While the focus of the meeting was specifically thimerosal, many comments unequivocally illustrate the uncertainly about the safety of other vaccine ingredients (particularly aluminum- which is still in many vaccines) and of the vaccine schedule as a whole, with respect to the very same neurodevelopmental concerns. Summarized in one statement:

The Simpsonwood Transcript is why no parent can accept any statement of “settled science” regarding vaccine safety at face value.

FULL DISCLOSURE:

I have personally read this entire document. I intentionally chose comments to highlight the disparity between definitive statements made by the CDC/other officials and private expert conversations, NOT to provide a summary or overview of the entire meeting. To avoid accusations of misrepresentation, each citation will be followed by its corresponding page number so that the reader may personally read it in its context. The first citation of each commenter will be followed by that individual’s biographical information provided on pages 1-8 of the transcript.

-Begin-

Dr. Johnston (Immunologist and Pediatrician and the University of Colorado School of Medicine and National Jewish Center for Immunology and Respiratory Medicine. Says “Adverse events related to vaccines has been of particular focus and interest for me mostly through serving on a series of committees dealing with the relationship between the vaccine and punitive adverse events.”):

…Thimerosal is in many vaccines because it is a preservative and lowers the rate of bacterial and fungal contamination that may occur during the manufacturing process, packaging and the use of vaccines in the field…” (p. 14)

…There are three licensed preservatives in the United States…We won’t talk about the other two today…Thimerosal is the most active and it has been utilized in vaccines since the 1930’s…” (p. 15)

Thimerosal functions as an anti-microbial after it is cleaved into ethylmercury and thiosalicylate, which is inactive…There is a very limited pharmacokinetic data concerning ethylmercury. There is very limited data on its bloodlevels. There is no data on its excretion. It is recognized to both cross placenta and the blood- brainbarrier. The data on its toxicity ,ethylmercury, is sparse. It is primarily recognized as a cause of hypersensitivity. Acutely it can cause neurologic and renal toxicity, including death, from overdose…” (p.15)

…And then at the end of the meeting ironically, Walt Orenstein asked the most provocative question which induced a great deal of discussion. That was, should we try to seek neurodevelopmental outcomes for children exposed to varying doses of mercury by using the Vaccine Safety Datalink data from one or more sites?” (p. 18)

…Finally I would like to mention one more issue. As you know the National Vaccine Program Office has sponsored two conferences on metals and vaccines…We just recently had another meeting that some of you were able to attend dealing with aluminum in vaccines. I would like to say just one or two words about that before I conclude…First, aluminum salts…reduce the amount of antigen and the number of injections required for primary immunizations. Secondly…it would present a significant burden to try and develop different vaccines for primary and subsequent immunizations…Aluminum and mercury are often simultaneously administered to infants …However, we also learned that there is absolutely no data, including animal data, about the potential for synergy, additivity, or antagonism, all of which can occur in binary metal mixtures that relate and allow us to draw any conclusions from the simultaneous exposure to these two salts in vaccines.” (pp. 19-20)

Dr. Clarkson (“associated with the mercury program through Rochester [NY] for a long time):

As you know, there is a paper just published on this now…if you are given mercury day by day as the guidelines are based on, whether it’s EPA, ATSDR, or FDA, these are based on constant daily exposure…Whereas we are just considering one single dose for vaccines. But nevertheless, a single dose from vaccines can raise blood levels by a certain amount…” (p. 22)

Dr. Brent (Developmental Biologist and Pediatrician from Thomas Jefferson University and Dupont Hospital for Children) repsonding to Dr. Clarkson’s comment above:

It’s just the sensitivity of the central nervous system, based on the mechanism that’s involved in producing the end result. You know the thalidomide data taught us that autism is related to the high brain and it produces it in the 22nd day of gestation, while the central nervous system from the standpoint of mental retardation, its most sensitive period is in the eighth week to the fifteenth week. That’s when we see neuro-maturation…I think that you have to realize that each of the developmental problems that have been evaluated here have a different stage where they are most sensitive from environmental factors.” (p. 23)

*** If you’re not familiar with the thalidomide reference he is making, you can learn the basics at this Wikipedia entry.

Dr. Johnson (State Public Health Officer in Michigan and member of ACIP) responding to Dr. Brent’s comment above:

“Are any of them different from birth, term birth to six months?” (p. 23)

Dr. Brent responds:

In Hiroshima, Nagasaki, you had severe mental retardation after 75 rads. If you give 75 rads to an infant, nothing will happen with regards to their central nervous system development. So you have this changing sensitivity throughout embryogenesis and early childhood development that makes it difficult to generalize.” (p. 23)

Dr. Johnson responds: “So the answer is that we don’t know…” (p. 23)

Dr. Sinks (Associate Director for Science at the CDC National Center for Environmental Health, Acting Division Director for the Division of Birth Defects, Developmental Disabilities and Disability Health):

I want to ask an unrelated question, and this has to do with potentially looking at confounding as we go through this. You mentioned the issue of aluminum salts. I know it’s an issue, but I don’t know the specifics of it. I wonder is their a particular health outcome that has been of concern that is related to the aluminum salts that may have anything to do with what we are looking at here today?” (p. 24)

Dr. Weil (Pediatrician representing the Committee on Environmental Health of the Academy):

Two things. One, up until this last discussion we have been talking about chronic exposure. I think it’s clear to me anyway that we are talking about a problem that is probably more related to bolus acute exposures, and we also need to know that the migration problem and some of the other developmental problems in the central nervous systems go on for quite a period after birth. But from all the other studies of other toxic substances, the earlier you work with the central nervous system, the more likely you are to run into a sensitive period for one of these effects so that moving from one month or one day from birth to six months of birth changes enormously the potential for toxicity. There are just a host of neurodevelopmental data that would suggest we’ve got a serious problem.” (p. 24)

The second point I could make is that in relationship to aluminum, being a nephrologist for a long time, the potential for aluminum and central nervous system toxicity was well established by dialysis data. To think there isn’t some possible problem here is unreal.” (p. 24-25)

Dr. Johnson responding to Weil:

Thank you, Bill, for your comments. As an old pediatrician, I had that same kind of feeling. That there must be a difference with age.” (p. 25)

Dr. Verstraeten (EIS Office at National Immunization Program- leading author of study linked above which is being discussed):

…Finally, and this may be the toughest one of all, how do we know that it is a Thimerosal effect? Since all vaccines are Thimerosal containing, how do we know that it’s not something else in the vaccines such as aluminum or the antigens?” (p. 50)

In conclusion, the screening analysis suggests a possible association between certain neurologic developmental disorders. Namely Tics, attention deficit disorder, speech and language disorders and exposure to mercury from Thimerosal containing vaccines before the age of six months…” (p. 50)

Dr. Weil:

I think what you are saying is in terms of chronic exposure. I think the other alternative scenario is that this is repeated acute exposures, and like many repeated acute exposures, if you consider a dose of 25 micrograms on one day, then you are above threshold. At least we think you are, and then you do that over and over to a series of neurons where the toxic effect may be the same set of neurons or the same set of neurologic processes, it is conceivable that the more mercury you get, the more effect you are going to get.” (p. 75)

Dr. Bernier (Associate Director for Science in the National Immunization Program):

…let me just reemphasize if I could the importance of trying to protect the information that we have been talking about. As many of you know, we are invited here. We have asked you to keep this information confidential. We do have a plan for discussing these data at the upcoming meeting of the Advisory Committee on Immunization Practices on June 21 and June 22. At that time the CDC plans to make a public release of this information, so I think it would serve all of our interests best if we could continue to consider this data The ACIP work group will be considering also. If we could consider these data in a certain protected environment. So we are asking people who have done a great job protecting this information up until now, to continue to do that until the time of the ACIP meeting. So to basically consider this embargoed information…” (p. 113)

Dr. Brent:

…The other thing is with some biological of some chemicals, the more you are exposed to them sometimes enzymes change with regard to excretion and metabolism. Is that known for mercury at all or is it totally unrelated to experience with the substance?” (p. 123)

Dr. Clarkson (repsonding to Dr. Brent’s question):

As you know, methylmercury and ethylmercury are slowly metabolized to inorganic mercury. The common mercury bond is broken. It’s achieved in two ways. The microflora in the intestinal tract break down methyl to inorganic and that’s how we get rid of it. Methylmercury goes through entroypathic recirculation from liver to bile, to intestine and back reabsorbed again and but for these obliging micro organisms in the GI tract, we wouldn’t really get rid of it. So does the microflora break it down to inorganic, which is not well absorbed and comes out in the feces.” (p. 124)

The other way it is metabolized is by phagocytic cells in almost every tissue in the body, probably including microglia in the brain. These phagocytic cells will also break down methylmercury. We don’t know for ethyl, but it is probably the same mechanism. So to what extent this change would do us, it’s not known. It’s an interesting question, but that’s not know (sic).” (p. 124)

Dr. Phillips (Family Medicine Private Practice in Seattle, Washington; Chair of Commission on Clinical Policies and Research for the American Academy of Family Physicians):

…What is the population attributable risk we are talking about? Even if we assume that all children completed the complete series of immunizations and they all include Thimerosal containing vaccinations, what is the burden of illness that we are talking about for these areas of interest? Speech delay and ADHD, that could possibly be attributable, if we believe these figures, to this exposure? What is the public health impact of the findings?” (p. 145)

Dr. Verstraeten (responding to Phillips’ question):

I haven’t come around to calculating the attributable risk…As you are aware, however, a large majority of children are vaccinated, so it will probably be quite high, if we believe the signal.” (p. 145)

Dr. Brent:

…many of your curves showed the rise in the relative risk, is that not correct?…I mean over a period of time, you give me the explanation of why over a period of time you got this increased risk.” (p. 161)

“Wasn’t it true that if you looked at the population that had 25 micrograms you had a certain risk and when you got to 75 micrograms you had a higher risk…What is your explanation? What explanation would you give for that? ” (p. 161)

Dr. Verstraeten (responding to Brent’s questions):

Personally I have three hypotheses. My first hypothesis is it is parental bias. The children that are more likely to be vaccinated are more likely to be picked up and diagnosed. Second hypothesis, I don’t know. There is a bias that I have not yet recognized, and nobody has yet told me about it. Third hypothesis. It’s true, it’s Thimerosal. Those are my hypotheses.” (p. 161)

Dr. Brent (in response):

If it is true, which or what mechanisms would you explain the finding with?” (p. 161)

Dr. Verstraeten (answers):

You are asking for biological plausibility?” (p. 162)

Dr. Brent:

Well, yes.” (p. 162)

Dr. Verstraeten:

When I saw this, and I went back through the literature, I was actually stunned by what I saw because I thought it is plausible.” (p. 162)

Dr. Brent:

…I would add a couple of things in there and that is that there are three reasons you might have the findings that you reported. One is, and we don’t have the data, that with the multiple exposures you get an increasing level, and we don’t know whether that is true or not. Some of our colleagues here don’t think that is true, but until we demonstrate it one way or the other, we don’t know that. The other thing is that each time you have an exposure there is a certain amount of irreversible damage and that as you exposure (sic) the damage adds up. Not because of dose but because they are irreversible. And the third thing is that maybe the most sensitive period is later, like in the fifth or sixth month. In other words, the sensitivity period is not the same over the first six months. Those would be explanations that you could only demonstrate with research, and probably not human…” (p. 163)

Dr. Weil:

…there is something else we won’t ever find out from these data, I don’t think, and that is whether or not 37.5 milligrams at one month is different than 37.5 milligrams at two months or three months, and that may be because of brain development. A critical issue and we can’t answer that from these data, no matter how they get manipulated or how many times we review. So some of the really gutsy questions from a person who is very concerned about neurodevelopment cannot be answered out of this. I don’t think we have anything that says this establishes this. All we can say is we are anxious and we need to get data the way we ordinarily do. We need to go to animal neurotox studies, developmental neurotox. We need to look at some other data that can be obtained to see if we get a comparable kind of impact, but let’s not try to refine and refine and refine these data. These are what they are. They show something and you cannot, by twiddling them and manipulating them, get much more out than Tom, Bob, and others have already done.” (p. 178)

Dr. Johnson:

…Do you think the observations made to date in the Vaccine Safety Datalink Project about a potential relationship between vaccines which contain Thimerosal and some specific neurologic developmental disorders, speech delay, attention deficit, ADHD and developmental delays constitute a definite signal? That is are a sufficient concern to warrant further investigation?…” (p. 179)

**** To the question above, most vote yes along with explanations for their votes which I will not cite in their entirety. These votes along with comments can be found on pages 179 and following. I will continue citing comments only as they are relevant to my stated goal. If a comment references a “yes” vote, it is a response to this.

Dr. Oakes (Chair of Biostatistics at the at the University of Rochester):

The other side to this is these data are out now. I mean they may not be public, but they will be. So this data exists, and then we can’t go back to the state where this duty has not been done, so there is a need to understand the data we have…” (p. 187)

Dr. Clover (Chair of the Department of Family and Community Medicine, University of Louisville, and ACIP member):

Maybe that’s an impossible question to answer, your first question, because no one around here is going to say that mercury per say is not a concern.” (p. 187)

Dr. Weil:

…My answer is yes. Although the data presents a number of uncertainties, there is adequate consistency, biological plausibility, lack of relationship with phenomenon not expected to be related, and a potential causal role that is as good as any other hypothesized etiology of explanation of the noted associations. In addition, the possibility that the associations could be causal has major significance for public and professional acceptance of Thimerosal containing vaccines. I think that is a critical issue. Finally, a lack of further study would be horrendous grist for the anti-vaccination bill. That’s why we need to go on, and urgently I would add.” (p. 187-188)

Dr. Brent:

…I remember when I was an intern, I rotated to Boston and there was a woman there by the name of Pricilla White. Because I had been a researcher before I was an intern, she would come down and show me these placentas from mothers who were diabetic and because they were using DES, and she would say to me look at that placenta. Look how healthy it is from mothers who are on DES. Of course she was eventually crushed psychologically when they found out that it caused adenocarcinoma of the vagina. And the implications here are much vaguer. That was an epidemic which was horrendous. Causing learning disabilities and behavioral disorders. ADD is a tremendous problem in our society and I think it is one we should be very concerned about.” (p. 190)

Although my gut reaction, which is totally irrelevant, is that it is probably not causatic, the only way you can come to a conclusion is through the data, and that’s the data I think we have got. Even if we put the vaccine in single vials and put no preservatives tomorrow, we still want the answer to this question. Because remember, epidemiological studies sometimes give us answers to problems we didn’t even know in the first place. Maybe from all this research we will come up with an answer for what causes learning disabilities, attention deficit disorders, and other information…” (p. 191)

Dr. Koller (Pathologist, Immunotoxicologist, College of Veterinary Medicine, Oregon State University):

…As you increase the vaccination, you increase effects, but you don’t know. You have modified live viruses. You have different antigens. There is a lot of things in those vaccinations other than mercury, and we don’t know if this is a vaccination effect or a mercury effect. But I am almost sure it is not a mercury effect. Positive as a matter of fact, and there are several experts particularly that have viewed this, the methylmercury aspect who I think would agree with that due to dose response.” (pp. 192-193)

Dr. Johnson (to Koller):

Loren, if you are absolutely sure there is no causal relationship, why would you answer yes to question one?” (p. 194)

Dr. Koller (responding to Johnson):

Because I think there are other factors. There is (sic) many confounders that have not been evaluated. Biological and environmental. As a matter of fact, in question two one of my answers is there does appear, however, to be a weak positive association between increased numbers of vaccinations and some neurological endpoints…Because as you increase mercury, you increase vaccinations, so there could be several other factors in those vaccinations that are causing these effects. There is (sic) also other types of vaccines that these children are exposed to. There might be a combination biological effect. It might be antigen effects. There is (sic) all kinds of possibilities here. Some of these are modified live viruses. I would assume they are modified live viruses. Something between the combinations or subsequent exposures in a sensitive population, or hypersensitive population may trigger some of these effects.” (p. 194)

Dr. Clarkson:

It will be interesting, Mr. Chairman, to know the conclusion of the aluminum meeting in Puerto Rico. What came out of that? Because we heard yesterday from the CI’s that the aluminum will correlate just as well as mercury with these results. Is Dr. Myers here? What were the conclusions?” (pp. 194-195)

Dr. Myers (Acting Director of the National Vaccine Program Office):

Well, first we didn’t have this data to study. We didn’t have available what we are discussing today. This study, so I am not sure.” (p. 195)

Dr. Clarkson:

What did they reveal about the all (sic) aluminum in terms of…” (p. 195)

Dr. Myers:

They thought there was an enormous margin of safety, that were well below concerns, but again they hadn’t seen these associations. By summary we thought we were well below the mercury as well.” (p. 195)

Dr. Stein (General Pediatrician and General Pediatric at University of California, San Diego; Co-Chair of the American Academy of Pediatrics recent practice guideline on diagnosis and evaluation of ADHD):

…Well, of course I answered yes also, but first I want to say thank you to everyone for giving me a course in Epidemiology. I learned a lot. I also want to congratulate the group that did the data and the study analysis. It also gave me a great respect for the problems of evaluating vaccine safety beyond what I had ever known or expected before, and obviously I have been practicing pediatrics for a long time…” (p. 195)

Dr. Johnson:

…In my opinion the evidence today is insufficient to determine whether or not Thimerosal containing vaccines caused the neurological sequelae in question…Now on the other hand, the data suggests that there is an association between mercury and the endpoints. ADHD, a well known disability, and speech delay as entered into the database…This association leads me to favor a recommendation that infants up to two years old not be immunized with Thimerosal containing vaccines if suitable alternative preparations are available. I do not believe the diagnosis justifies compensation in the Vaccine Compensation Program at this point.” (p. 199)

I deal with causality, it seems pretty clear to me that the data are not sufficient one way or the other. My gut feeling? It worries me enough. Forgive this personal comment, but I got called out at eight o’clock for an emergency call and my daughter-in-law delivered a son by C-section. Our first male in the line of the next generation, and I do not want that grandson to get a Thimerosal containing vaccine until I know better what is going on. It will probably take a long time. In the meantime, and I know there are probably implications for this internationally, but in the meantime I think I only want that grandson to only be given Thimerosal-free vaccines.” (pp. 199-200)

Dr. Brent:

…The epidemiological data is valid, as is (sic) the associations that were reported. It is more difficult, if not impossible, to refute a causal association based on this study. Therefore, the question of causal association remains unanswered until we obtain the data that was suggested in the answer to the first question I wrote.” (p. 205)

Dr. Weil:

…The number of dose related relationships are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant.” (p. 207)

…The increased incidence of neurobehavioral problems in children in the past few decades is probably real…I work in the school system where my effort is entirely in special education and I have to say that the number of kids getting help in special education is growing nationally and state by state at a rate we have not seen before. So there is some kind of an increase. We can argue about what it is due to…But there are certainly more kids with ADD and there are more kids with speech and language disorders than there have been in the past.” (p. 207)

…The rise in the frequency of neurobehavioral disorders, whether it is ascertainment or real…is much too graphic. We don’t see that kind of genetic change in 30 years.” (p. 207-208)

Dr. Oakes:

…I don’t think we have seen any evidence that the causal agent, if there is one, is Thimerosal and not some other constituent of the vaccine.” (p. 211)

Dr. Brent (responding to Oakes):

Could you say that again?” (p 211)

Dr. Oakes (responding to Brent):

We haven’ seen any evidence that it is the mercury, if there is some damage being caused, that these associations are real, that it is an association with mercury. The question is what other things are in there that are also potential causal agents?…” (p. 211)

Dr. Myers:

Can I go back to the core issue about the research? My own concern, and a couple of you said it, there is an association between outcomes and vaccination that worries both parents and pediatricians. We don’t really know what the outcome is, but it is one that worries us and there is an association with vaccines. We keep jumping back to Thimerosal, but a number of us are concerned that Thimerosal may be less likely than some of the other potential associations that have been made. Some of the other potential associations are number of injections, number of antigens, other additives. We mentioned aluminum and I mentioned yesterday aluminum and mercury. Antipyretics and analgesics are better utilized when vaccines are given…and yet all the questions I hear we are asking have to do with Thimerosal. My concern is we need to ask the questions about the other potential associations, because we are going to the Thimerosal-free vaccine. If many of us don’t think that is a plausible association because of the levels and so on, then we are missing looking for the association that may be the important one. I thought I would put that out. That we shouldn’t just think in terms of mercury.” (pp. 231-232)

Dr. Chen (Chief of Vaccine Safety and Development at the CDC National Immunization Program) responding to Myers:

To address Marty, I think that is quite reasonable, although we have a limited amount of manpower because of what we just studied. At the moment, I would think most people around the room would argue that these are biologically plausible outcomes potentially related to mercury, and then we will keep the other ones in mind…” (p. 233)

Dr. Myers (responding to Chen):

I agree with you, Bob, but the think the conclusion (sic) is that there is an association between vaccinations and the outcomes that we cannot reject and of which one compliment of the vaccines that is associated is Thimerosal, but it is only one of the associations. I don’t think it is any more plausible than some of the others. And I think I heard several of the consultants say the same thing.” (p. 233)

Dr. Caserta (Chief Medical Officer for the Vaccine Compensation Program):

One of the things I learned at the Aluminum Conference in Puerto Rico that was tied into the metal lines in biology and medicine that I never really understood before, is the interactive effect of different ions and different metals when they are together in the same organism. It is not the same as when they are alone, and I think it would be foolish for us not to include aluminum as part of our thinking with this.” (p. 234)

Dr. Orenstein (CDC’s Director of National Immunization Program):

You have to add smallpox and IPV. In fact, one of the studies from the perinatal project suggested an increased risk of tumors in the off spring (sic) of parents who received three CBL. Heard of these associations.” (p. 234)

Dr. Clements (Expanded Program on Immunization, WHO, Geneva):

…I am really concerned we have taken off like a boat going down one arm of the mangrove swamp at high speed, when in fact there was no (sic) enough discussion really early on about which way the boat should go at all. And I really want to risk offending everyone in the room by saying that perhaps this study should not have been done at all, because the outcome of it could have, to some extent, been predicted and we have all reached this point now where we are left hanging, even though I hear the majority of the consultants say to the Board that they are not convinced there is a causality direct link between Thimerosal and various neurological outcomes.” (pp. 247-248)

I know how we handle it from here is extremely problematic. The ACIP is going to depend on comments from this group in order to move forward into policy, and I have been advised that whatever I say should not move into the policy area because that is not the point of this meeting…But there is now the point at which the research results have to be handled, and even if this committee decides that there is no association and that information gets out, the work has been done and through freedom of information that will be taken by others and used in other ways beyond the control of this group. And I am very concerned about that as I suspect it is already too late to do anything regardless of any professional body and what they say.” (p. 248)

My mandate as I sit here in this group is to make sure at the end of the day that 100,000,000 are immunized with DTP, Hepatitis B, and if possible Hib, this year, next year, and for many years to come, and that will have to be with Thimerosal containing vaccines unless a miracle occurs and an alternative is found quickly and is tried and found to be safe.” (p. 248)

So I leave you with the challenge that I am very concerned that this has gotten this far, and that having got this far, how you present in a concerted voice the information to the ACIP in a way they will be able to handle it and not get exposed to the traps which are out there in public relations…How will it be presented to a public and a media that is hungry for selecting the information they want to use for whatever means they have in store for them…I have the deepest respect for the analysis that has been done, but I wonder how on earth you are going to handle it from here.” (p. 249)

-End-

As a former very pro-vaccination individual, these are the things that bother me the most about this interaction:

    • Experts do not know what I consider to be basic and necessary safety information for a multitude of vaccine ingredients and how they may or may not interact with one another and affect the body.
    • The absence of the above information is in no way considered an impediment to vaccine approval, utilization, and forceful recommendation.
    • Prior to reading private conversations such as this, I assumed the experts did know these basic and necessary data.
    • The public is preliminarily assured of safety before anyone has any idea of whether or not these assurances are accurate, even before scientific data has been sufficiently collected and/or reviewed.
    • Given evidence of the distinct possibility that some element of vaccination (not sure which, it could be multiple things) is directly associated to neurological developmental disorders (among other things), experts feel justified in withholding this information from the public to ensure that confidence in vaccination is not lost.
    • Although aluminum was clearly identified as (at the very least) an ingredient equivalently dangerous to mercury, there was not, and there has not been, any effort to remove this ingredient or seriously study it.

These realizations are particularly unsettling in light of the 2011 Institute of Medicine Report. The ICAN white paper on Vaccine Safety summarizes their findings on pages 8-9:

This third IOM Report reviewed the 158 most common vaccine injuries claimed to have occurred for vaccination from varicella, hepatitis B, tetanus, measles, mumps, and/or rubella. The IOM located science which ‘convincingly supports a causal relationship’ for 14 of these serious injuries including pneumonia, meningitis, hepatitis, MIBE(deadly brain inflammation a year after vaccination), febrile seizures, and anaphylaxis. The review found sufficient evidence to support ‘acceptance of a causal relationship’ for 4 additional serious injuries. The IOM, however, found the scientific literature was insufficient to conclude whether or not those vaccines caused 135 other serious injuries commonly reported after their administration…For the remaining 135 vaccine-injury pairs, over 86% of those reviewed, the IOM found that the science simply had not been performed.”

I won’t list all of the 135, but the following is a sampling: Encephalitis, Encephalopathy, Seizures, Transverse Myelitis, Multiple Sclerosis, Guillain-Barre, Systemic Lupus Erythematosus, Juvenile Ideopathic Arthritis, Rheumatoid Athritis, Fibromyalgia, SIDS. (Relevant IOM Report link here)

At the outset of this article I asked the reader to reflect on the last two statements made by the AAP and PHS. After considering this interaction between experts, how would you answer the following questions: 1) Are they sufficiently transparent and unbiased? 2) Do you trust that you are being given adequate information to make your own decisions? 3) Do you agree with policies and recommendations that have been made in the interest of public health? 4) Going forward, would you accept official statements at face value and continue to vaccinate yourselves and your children, no questions asked? 5) Does it bother you that the US is reaching epidemic levels of autoimmune diseases and neurological behavioral disorders, yet the cause is a complete mystery? 6) Might the interest of the public health be at odds with your interest, as a parent, in the specific health of your child? 7) Is the risk of historically benign, low risk, short-lived infections such as measles, mumps, and chicken pox beginning to look very attractive compared to the vast number of unknowns and high stakes long- term, life- altering diseases potentially associated with vaccination?

 

If you answered those first four questions with a “no” and the last three with a “yes”, welcome to the “vaccine hesitant” club.

 

8 Things Your Doctor Didn’t Tell You About the Flu Shot

It’s that time of year. We’re smack dab in the midst of flu pandemonium. Flu shot propaganda is FULL force. Instead of going over all the glowing accolades heaped upon the flu vaccine, I’m going to cut right to the chase and tell you what you NEED to know about it in order to make an informed decision regarding whether or not it’s a good choice for you and your family. Information that, unfortunately, fails to get disclosed to the public.

  1. The flu vaccine is essentially a brand new, experimental vaccine each and every year.Dr. Mark Geier is very pro-vaccine. He is well respected, has worked with the FDA, and most notably was a member of the 4 person team that replaced the unsafe DTP vaccine with the somewhat safer version that we have today (DtaP). Yet, even Dr. Geier can’t get behind the flu vaccine. He explains in the video below that, by law, vaccines must have two double blind field trials in order to show efficacy and long term safety. However, the flu vaccine is reformulated each and every year in order to anticipate the flu strains that will be prevalent in a given season. Geier points out that it is impossible to test for efficacy (how can you test a strain that hasn’t come yet?) or long term safety (manufacturers have approximately 2 weeks to test safety) when rushing a vaccine to market each year. Geier notes that, by law, vaccines that have not (or in the case of the flu shot) cannot be adequately safety tested, must be disclosed to the public as “experimental.” This is not happening.

  1. The flu vaccine still contains mercury (thimerosol).Most everyone remembers the big uproar about mercury in vaccines. While some people maintain that mercury in vaccines is not a problem, I’ll list a few statistics from the National Vaccine Information Center:
    • .5 ppb (parts per billion) mercury = kills human neuroblastoma cells (Parran et al., Toxicol Sci 2005; 86:132-140).
    • 2 ppb mercury = US EPA limit for drinking water
    • 20 ppb mercury = Neurite membrane structure destroyed (Leong et al., Neuroreport 2001; 12:733-37)
    • 200 ppb = level in liquid the EPA classifies as hazardous waste
    • 50,000 ppb mercury = current “preservative” level mercury in multi- dose flu (94% of supply), meningococcal and tetanus (7 and older) vaccines. This can be confirmed by simply analyzing the multi-dose vials.Vaccine manufacturers began removing mercury in vaccines in 2000. Single dose flu vaccines are advertised as “mercury free,” however it should be noted that they still contain “trace amounts” of mercury. Other than that, they are completely identical to the multi-dose vials. They are NOT “free of harmful ingredients” as I have heard some individuals (even nurses) erroneously claim.
  1. The flu vaccine is rarely over 50% effective any given year. This year (2017-18 season) it is particularly poor-performing- estimated at only 10% effective.

Here’s a CDC graph of flu vaccine efficacy over the years. First, I love how this graph is even a little visually deceptive since the top attainable effectiveness percentage is only 70% rather than 100% (which most people just taking a glance at the graph would assume). Other than that, note that the flu shot has failed to surpass the odds of a coin flip in 9 out of 13 years. Three of those years it failed to surpass 21% efficacy. Based on this year’s abysmal efficacy in Australia, the efficacy in the US this year is estimated to be a whopping 10%. Stated another way- 90% of individuals who receive the flu shot, will receive no protection against the flu.

  1. The flu shot can have some very serious side effects, which are almost NEVER mentioned.While the benefits of the flu shot are touted ad nauseam, the risks are seldom deemed worth mentioning. A quick look at the flu vaccine pkg insert is quite eye opening. Please note: the screenshots below are for the Fluarix Quadrivalent vaccine:

Notice first, the immediate mention of Guillain Barre Syndrome under the title “Warnings and Precautions.” The CDC defines Guillain Barre Syndrome as, “a rare disorder in which a person’s own immune system damages their nerve cells, causing muscle weakness and sometimes paralysis. GBS can cause symptoms that usually last for a few weeks. Most people recover fully from GBS, but some people have long-term nerve damage. In very rare cases, people have died of GBS, usually from difficulty breathing.”

While admitting that the 1976 flu vaccine caused an 8 fold increased risk of GBS (cause yet undetermined), the CDC claims that subsequent flu shots have not been adequately causatively related to GBS.

While, the CDC uses the word “rare” frequently in their discussion of GBS, this doesn’t seem to reflect real world experience. Just this week, in my hometown, a healthy 19 year old contracted GBS most likely due to a flu vaccine. The screenshots of the Facebook post are below- names are blacked out for privacy.

In the comments below this woman’s post, I have counted no less than 7 individuals stating that they either knew someone or had themselves contracted GBS from the flu shot. (Not my definition of rare.) This is not surprising at all, since by the CDC’s own admission, the VAERS system that they rely on to track vaccine adverse events is inefficient in collecting this data. According to my research for a separate article on the inadequacy of the VAERS system in tracking adverse vaccine events, the VAERS system is estimated to underreport vaccine injury by a whopping 90%. Let that sink in a moment.

Now direct your attention at the list of side effects from the flu vaccine: malaise, drowsiness, appetite loss, myalgia, vomiting, and fever. Basically, the side effects of the flu shot, are feeling as if you have… the flu…

Note all of the serious conditions listed under the “Postmarketing Experience” heading:

I don’t know about you, but I’m beginning to believe I’d be better off taking my chances with the flu!

Finally (and arguably most disturbing):

Even though the CDC recommends the flu vaccine to pregnant mothers and the flu vaccine is heavily marketed toward them: “There are insufficient data on Fluarix Quadrivalent in pregnant women to inform vaccine- associated risks.” Restated- they cannot tell you that the flu vaccine is safe for a pregnant woman or her unborn child because they do not have safety tests. They can’t! How many pregnant women would voluntarily sign up for an experimental vaccine??

Wait a minute…check the highlighted line above, “There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fluarix Quadrivalent during pregnancy. Healthcare providers are encouraged to register women by calling 1-888-452-9622.” Restated- if you are currently pregnant and receive a flu vaccine on recommendation of your doctor and your doctor didn’t disclose to you that this vaccine has not been tested on pregnant women- you and your child have just become unwitting guinea pigs.

  1. The NVICP pays out more to flu vaccine victims than any other vaccine.

Most individuals aren’t aware, but vaccine manufacturers and doctors have no legal liability for damage caused to an individual by a vaccine. They were granted indemnity in the 1986 National Childhood Vaccine Protection Act which was later expanded in the 2011 Supreme Court decision Bruesewitz vs Wyeth. This act created a “vaccine injury court” in which individuals injured by vaccines can file a claim in order to receive a settlement from a fund that is set aside specifically for that purpose. Every three months the Advisory Commission on Childhood Vaccines meets and the Dept of Justice releases a report listing cases settled for vaccine injuries and deaths. In the report issued September 20, 2016 (covering 5-15-17 to 8-15-17) 83 of the 113 cases settled were for injuries and deaths due to the flu vaccine. The clip below is a portion of that list. The complete report can be accessed here, and past reports can be accessed here. As you scroll the report for the adverse effects due to the flu vaccine, notice the incidence of GBS and SIRVA.

  1. There is NOT sufficient evidence that the flu shot will lessen severity of the flu.This bit of shady information is often quoted as fact. The CDC backs this claim. However, the American Society for Microbiology states, “Individuals who have been recently vaccinated may still get infected with influenza (“vaccine failure”). Among these individuals, it is not known whether recent vaccination can attenuate the course of illness, that is, lessen the severity and/or duration of symptoms associated with influenza.”

    Upon closer investigation, the CDC is basing this claim on one study conducted in hospitalized flu patients in 2013-14 (a year when the vaccine was a good match for the strain that circulated that year), in which the lead researcher is a CDC employee, and numerous supporting researchers are employed by the Dept of Health in various states. The sample size is not listed in the study. Besides the fact that nothing can be legitimately asserted based on ONE study, can you say conflict of interest? Also, of note is the fact that this study was conducted in a year when the flu vaccine had higher than average efficacy. It cannot be stated from this study, that a poorly efficacious flu vaccine would have any affect on the severity of the flu.

  1. The flu death statistics that are used to urge the population into flu hysteria are massively inflated.The CDC claims that there are a whopping 36,000 deaths attributable to flu and flu related complications. Incidentally, the National Vital Statistics System in the US disagrees. Even Huffington Post calls the CDC out on this one, and that’s saying a lot! They write, “for example, annual flu deaths in 2010 amounted to just 500 per year- fewer than deaths from ulcers (2,977), hernias (1,832), and pregnancy and childbirth (825), and a far cry from the big killer such as heart disease (597,689) and cancers (574,743).” They further note than even this number could be exaggerated, “Only about 15-20 per cent of people who come down with flu-like symptoms have the influenza virus- the other 80-85 per cent actually caught rhinovirus or other germs that are indistinguishable from the true flu without laboratory tests, which are rarely done. In 2001, a year in which death certificates listed 257 Americans as having died of flu, only 18 were positively identified as true flus. The other 239 were simply assumed to be flus and most likely had a few true flus among them.”

    So, how does the CDC go about inflating their numbers? They bundle together flu and pneumonia deaths. The HuffPo author writes, “Pneumonia, according to the American Lung Association, has more than 30 different causes, influenza being but one of them. The CDC itself acknowledges the slim relationship saying, ‘only a small portion of deaths…only 8.5 per cent of all pneumonia and influenza deaths [are] influenza related.”

  1. The CDC and the government incite hysteria in order to create demand for the flu vaccine and thus avoid massive monetary loss for unused flu vaccines each year.As I mentioned above, a new flu shot is manufactured each year. The FDA actually sets an expiration for each season’s flu vaccine of June 30. NBC carried this Associated Press article back in 2007 after a mild flu season led to poor flu shot sales, “more than 10 million of a record 110 million produced- will be destroyed before a new supply is guaranteed…Wasted vaccine means lost money for drug companies and one stopped making flu shots because of it- setting the stage for a flu shot shortage in 2004…After the 2002-03 season, Wyeth Pharmaceuticals had to destroy a third of the 20 million doses it produced because of low sales. The company lost about $35 million and then dropped out of the flu shot business…Doctors and VNA clinics will get a refund of taxes paid but will still lose about $10 per dose. Losses of up to $20,000 a season have caused some clinics to quit offering shots.”

    This article archived in the National Institutes of Health (NIH) library chronicles a “Seven Step Recipe” given at the 2004 National Influenza Vaccine Summit co-sponsored by the CDC and the American Medical Association, “One step of a ‘Seven- Step “Recipe” for Generating Interest in, and Demand for, Flu (or any other) Vaccination’ occurs when ‘medical experts and public health authorities publicly…state concern and alarm (and predict dire outcomes)- and urge influenza vaccination.’…Another step entails ‘continued reports…that influenza is causing severe illness and/or affecting lots of people, helping foster the perception that many people are susceptible to a bad case of influenza.’”

Do you feel sufficiently manipulated yet?

Conclusion

This season is definitely shaping up to be a “bad” flu year and nobody likes to get the flu. At the end of the day, the choice belongs with you when it comes to whether or not getting the flu shot is a good choice for you or your children. There may be some cases in which, after evaluating the benefits and risks, getting a flu shot is the right choice. However, one thing is certain: No one is in the position to make an educated decision about the flu vaccine when its risks are censored, its benefits exaggerated, and the actual danger of the flu inflated. Creating demand by lying about flu deaths and enlisting the medical field as flu shot salesmen to avoid loss of profit for vaccine manufacturers is wrong no matter how you slice it- particularly since otherwise healthy individuals are being put at unnecessary risk for horrific adverse effects due to this flu shot scam.

Polysorbate 80 in Vaccines: Is it safe?

Vaccines are loaded with ingredients that the average person doesn’t know much, if anything, about. We don’t know why any particular ingredient is needed in a vaccine, how that ingredient interacts with other vaccine ingredients, or how that ingredient will affect our bodies when it is injected. We assume that scientists who create vaccines know the answer to these important questions prior to licensing for public use. We assume our doctors have read all the scientific studies exhibiting the safety of the various vaccine ingredients prior to assuring us that any given vaccine is safe for us or our children. But, have the studies been done? Can these scientists and our doctors definitively answer these basic, yet necessary, questions about the safety of each ingredient?

We’ll talk about one such ingredient today- polysorbate 80. The CDC Vaccine Excipient and Media Summary lists Polysorbate 80 as an ingredient in the following vaccines:

    • DTaP (Infanrix)
    • DTaP – IPV (Kinrix and Quadracel)
    • DTaP- HepB- IPV (Pediarix)
    • DTaP- IPV- Hib (Pentacel)
    • HPV (Gardasil and Gardasil 9)
    • Influenza (Agriflu and Fluarix)
    • Meningococcal (MenB- Trumenba)
    • Pneumococcal (PCV13 – Prevnar 13)
    • Rotavirus (Rotateq)
    • TdaP (Boosterix)

What is polysorbate 80?

Polysorbate 80 is used as an emulsifier/stabilizer in vaccines, but you won’t find any safety information from CDC documents. It’s not listed on the CDC Ingredients of Vaccines Fact Sheet.

The Drugs.com definition states: “Polysorbate 80 is a common excipient and solubilizing agent used in the pharmaceutical industry. Polysorbate 80 (also known as polyoxyethylene-sorbitan-20 mono-oleate, or Tween 80) is used in the pharmaceutical and cosmetic industry in lotions, medical preparations (eg vitamin oils, vaccines, and intravenous preparations) and as an excipient in tablets. A solubilizing agent acts as a surfactant and increases the solubility of one agent into another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent.”

In other words, it allows the vaccine ingredients that normally behave like oil and water, to mix.

Children’s Hospital of Philadelphia (CHOP), the soapbox for vaccine apologist, Dr. Paul Offit, (if you’ve never heard of Offit, he’s the chief of infectious disease at CHOP who famously said that babies could tolerate “10,000 vaccines at once” and who holds a $1.5 million research chair funded by Merck) lists the only “pediatrician” information I could find regarding the safety of polysorbate 80 in vaccines:

“The HPV vaccine contains polysorbate 80 as a stabilizer. Some stories on the internet have suggested that polysorbate 80 in this vaccine causes infertility. First, it is important to know that the HPV vaccine does not cause infertility. Second, polysorbate 80 has been used for years as an emulsifier to make ice cream smooth and to slow melting. A typical serving of ice cream (½ cup) may contain 170,000 micrograms of polysorbate 80. On the other hand, the amount of polysorbate 80 in each dose of the HPV vaccine- 50 micrograms- is very small. Therefore, polysorbate 80 isn’t contained in vaccines at quantities that could possibly do harm.”

Frankly, if the pediatrician has to appeal to the old “you eat it in your food and it hasn’t killed you, so you shouldn’t be worried about injecting it into your body” spiel, instead of offering up safety studies- it’s a red flag. The amount of polysorbate 80 in vaccines can’t possibly harm me? Cool- show me the studies that identify “safe” injectable levels. I’ll be waiting…

Is polysorbate 80 safe in our food?

It depends on what you consider “safe.” If by safe you merely mean that you don’t drop dead immediately from ingesting it, then polysorbate 80 fits that description. However, if you broaden your definition to include the long-term and cumulative risk of ingesting polysorbate 80, you may be interested in these studies:

  1. This study published in the American Academy of Cancer Research found that a diet including regular consumption of emulsifiers experienced exacerbated tumor development and chronic low-level inflammation. This chronic inflammation was also associated with inflammatory bowel diseases like Crohn’s and is observed in colorectal cancers. The study also points out that occurrence of colorectal cancers “have been markedly increasing since the mid-20th century.”
  1. This 2015 study also linked polysorbate 80 to gut inflammation, negatively altered gut bacteria (we now know that a healthy gut biome is necessary for immune function), obesity and metabolic syndromes.

If ingested polysorbate 80 is causing inflammation in the gut, is it a stretch to question if injected polysorbate 80 is causing inflammation (a hallmark of autoimmune disease) elsewhere in the body?

There is no shortage of troubling information about polysorbate 80 in vaccines:

  1. They don’t have enough data to answer basic safety questions.

    The Science Lab Material Data Sheet for polysorbate 80 highlights my point. Section 3 of this report lists the potential chronic health effects. Carcinogenic, mutagenic, and teratogenic effects as well as the developmental toxicity are all “unavailable.” (Synonym for “unknown”?) However, section 11 states these special remarks on the chronic effects on humans:

    “May cause adverse reproductive effects based on animal test data. No human data found. May cause cancer based on animal test data. No human data found. May affect genetic material (mutagenic).” Under the special remarks on other toxic effects on humans is stated, “Animal studies have shown it to cause cardiac changes, changes in behavior (altered sleep time) and weight loss (upon repeated or prolonged ingestion.) However, no similar human data has been reported.”

    – Of course, injected polysorbate 80 isn’t discussed in this report at all. If you’re like me, there are way too many statements of “no human data found” for comfort.

  1. Polysorbate 80 may allow other vaccine ingredients to cross the blood brain barrier.

    • This is huge- as in a total game changer. In fact, it is used in other medications for that very purpose. Dr. Lawrence Palevsky points out:

      “Polysorbate 80 is used as an emulsifier by the pharmaceutical industry to enhance the delivery of chemicals/drugs from the blood into the brain across the blood brain barrier (BBB). Being that the BBB is impermeable to many things in the bloodstream, researchers needed to find a way to deliver chemicals/drugs into the brain from the bloodstream in order to treat hard-to-reach brain infections/lesions/tumors, etc. Polysorbate 80 is one such chemical that helps in this delivery.”

    • This Science Direct link discusses the role of polysorbate 80 in crossing the BBB: http://www.sciencedirect.com/science/article/pii/S014296120300855X Could polysorbate 80 be allowing other vaccine ingredients (some of which are known neurotoxins) such as aluminum, mercury, bacterial/viral/yeast protein antigens which would be harmful to the brain, to cross the BBB?
  1. Injected polysorbate 80 metabolizes into chemicals that are much more toxic than the original chemical.
      • These studies show that after injection polysorbate 80 breaks down into sorbitol and ethylene oxide. The NIH toxicology network states that sorbitol is “not to be injected,” and that ethylene oxide is a “known carcinogen,” among other concerning toxicity information.
  1. Polysorbate 80 has been linked to infertility.
    • In this study, baby female rates were injected with polysorbate 80 at days 4-7 after birth which resulted in their accelerated maturation, caused changes to the vagina and womb lining, hormonal changes, ovary deformities and degenerative follicles.
    • This study researching the link between the HPV vaccine and infertility cited the findings of the rat study above and notes insufficient and poorly designed research on fertility effects in clinical trials for the HPV vaccine. If you’ll recall, the Children’s Hospital of Philadelphia (CHOP) quote above claims that there is no link between the HPV vaccine and infertility. However, this study states unequivocally that this claim cannot be asserted:

      “The relevance of polysorbate 80 ovarian damage to the cases presented here is unresearched and unknown and assurances of ‘no biologically plausible’ link between HPV4 vaccine and ovarian effects cannot be given.” (emphasis mine)

    • If you’ll recall, CHOP also drew a comparison to ingested polysorbate 80. This study also addresses fertility effects of ingested polysorbate 80:

      “The chemical is present in orally ingested medicines and foods, but did not affect rat reproduction when subject to digestive processes at up to 5% of their oral intake. It did decrease rat reproduction at 20% of their oral intake.”

    • Sounds like CHOP is comfortable making claims that actual scientists researching the HPV vaccine will not make.
    • As an interesting and possibly relevant side note, a patent for a vaccine that would decrease animal fertility has been submitted by the University of Georgia Research Foundation. This patent lists polysorbate 80 as a preferable ingredient: “and additionally preferably contains Tween 80 (polysorbate 80).” According to the patent “Background of the Invention” section, this vaccine is an effort to controlling dog overpopulation. Another quote from the patent:

      “Collegenase treatment of zona pellucida proteins known to alter the proteins in a way that can be demonstrated immunocytochemically. Abnormal estrus cycles, characterized by constant or prolonged estrus, and other deleterious side effects, such as ovarian cyst formation, were found to be associated with the vaccinations (C. Mahi-Brown, Am. J. Reprod. Immunol. Microbiol..18,94-103 (1988)), and were never satisfactorily explained.” (emphasis mine)

      • Those phrases in bold echo findings in the polysorbate 80 rat study linked above.
  1. Injected polysorbate 80 has been identified as the cause of anaphylaxis.
    • The study, Anaphylaxis Due to the Excipient Polysorbate 80, appeared in the Annals of Allergy, Asthma and Immunology in December of 2005. (page 21 on the pdf linked above) “In our conclusion, based on our results and the literature reviewed, we believe that polysorbate 80 should be included in the test battery for allergy to medications such as corticosteroids, since it could be a cause of anaphylaxis of unknown etiology.”
    • The NIH link for this study notes, “Polysorbate 80 is a ubiquitously used solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions.”
  1. Can injected polysorbate 80 negatively affect our immune system?
    • In addition to its role as an emulsifier/stabilizer, polysorbate 80 also functions as a vaccine detergent. Detergents are used in killed virus vaccines (such as the flu vaccine) to split or disrupt the virus particles. Detergents cause cells to leak or explode by weakening their cell walls. The danger is that this process mimics our bodies’ membrane attack complex, or MAC. This link explains in detail why this is so dangerous: http://www.sailhome.org/Concerns/Vaccines/MAC.html
      • A “cliff’s notes” version of the article above:
        • “The Complement system is a chain-reaction of biochemical events that help remove pathogens from the body…The Membrane Attack Complex (MAC) is part of the Complement system- and it is one of the immune system’s ultimate weapons…Killing cells by punching holes into them makes the MAC extremely potent- and also extremely destructive if it runs out of control. For this reason the MAC (and the Complement system in general) is tightly regulated by additional proteins.”
      • “When activated, the Complement system triggers such events as: increased arachidonic acid metabolism leading to acute inflammation and damage to nearby tissue; histamine release with its effects on allergic response, digestion, and neurotransmitter function; pyrogen release and the onset of fever.”
      • “Detergents represent the worst kind of autoimmune dysfunction- they randomly destroy any kind of host cell with no mechanism for regulating destructive activity.”
      • A troubling comparison of the characteristics of MAC vs vaccine detergents:
              1. Both cause cells to leak or explode.
              2. MAC is “regulated by proteins”, whereas detergents are completely unregulated. “like the MAC out of control.”
              3. MAC “targets foreign cells and avoids self-cells”, while detergents “hit cells randomly”.
              4. MAC “responds to signals calling off the attack”, but detergents “continue to destroy cells.”
              5. MAC is “integrated into complex (and sensitive) signaling and feedback relationships”, however detergents are both “foreign” and “disruptive” to these systems.

Should we be comfortable with polysorbate 80 as a vaccine ingredient?

For me, the answer is an emphatic no- until scientists can adequately exhibit favorable answers to Dr. Palevsky’s following questions:

  1. What vaccine materials get across the BBB, with the help of polysorbate 80, into the brain of children? And
  2. What effect do they have once they get into the brain? Do they contribute to inflammation, toxicity, encephalitis?

Since polysorbate 80 works as an emulsifier, and will also enhance delivery of vaccine materials into the rest of the cells of the body,

  1. What vaccine materials enter the cells of our bodies?
  2. Do they remain in the cells once they get there?
  3. Do they impair any parts of the cells, its mitochondrial DNA, nuclear DNA, or other cellular apparatuses- endoplasmic reticulum, golgi apparatus?
  4. Do they become part of the DNA of the cells since there are whole DNA strands from live viruses in the vaccines, along with foreign animal DNA and bacterial/viral/yeast protein antigens?
  5. If they do become part of the DNA, how does this change the function and/or regulatory systems in the cells?
  6. Do the materials from vaccines (eg aluminum, mercury, formaldehyde) entering through the cell membranes at the hands of polysorbate 80 do anything to impair the electrical charge of the cell membrane, or impair/alter the way materials enter or exit the cell through the cell membrane (nutrients, cellular wastes, manufactured proteins, or enzymes?)

Since babies have a poorly developed BBB, which may not solidify for at least the first 6 months, or maybe longer if they have a brewing inflammatory condition yet to be determined that has delayed the full development of the BBB, then questions 3-8 apply to their brains as well.

Until we have studies providing answers to these questions, don’t let anyone tell you “Well, your polysorbate 80 loaded ice cream hasn’t killed you yet, so the small amount in these vaccines is probably ok too.” If you’re like me, you believe our children require proof- not a “probably.”