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.

 

Creationist Theory on Ascending Complexity of Life Ordered in Precambrian/lower Cambrian Sediments

In my opinion, one of the most challenging arenas of science for a Young Earth Creationist (YEC) is geology. Both sides of the debate have the same data to work with- the geologic column. Likewise, they share the same goal- reconstructing a plausible theory to explain the earth’s history. The very deepest layers in this geological column, the Precambrian and lower Cambrian, pose quite a mystery for us to solve since they contain the very first signs of life.

Of particular interest within these lowest levels, is the presence of a clear order of organisms increasing in complexity along the vertically ascending layers of sediment. The questions are: how do we explain the method by which these layers came to be deposited historically and what is the significance of the increasing complexity in the fossil record? Creationists and Evolutionists have two vastly different answers largely due to the presuppositions underlying their respective world views. These presuppositions unavoidably affect interpretation.

Evolutionary theory sees the layers as being deposited over millions of years, containing the record of the evolution of life from simple to complex. This view traditionally enjoys the “edge” in modern thought for two reasons. First, it’s the only view most people are aware of since it is the only one approved in public education systems; and second, it is certainly a simple/obvious explanation if one agrees with evolutionary presuppositions.

YEC theory sees the deposition of these deepest layers as the result of one catastrophic event- the global flood recorded in Genesis chapters 6-9 which devastated the entire earth. Since YEC’s maintain that life didn’t evolve, but came into existence simultaneously according to the Biblical 6 day Creation narrative, the difficulty has been arriving at an explanation of the increasing complexity demonstrated in the fossil record. However, Dr. Kurt Wise (Ph.D. in Paleontology and M.A in Geology from Harvard) described a theory during his presentation at the 2017 “Is Genesis History?” Conference proving that the evolutionary reconstruction is not the only one data supports. Wise admits that “Creationist palaeontology is an immature field” and that theirresources… are severely limited.” However, Wise believes his theory is the one aligning most closely with the evidence.

Shared Evidence

Early in Dr. Wise’s presentation, he sets the stage by documenting the data both evolutionists and creationists have to interpret:

At the base of the geologic column, the lowest level is referred to as the “Precambrian.”

                                                  Image via Wikimedia Commons

Dr. Wise notes that there are only 12 geographical locations where geologists can access the complete Precambrian series of sediments exhibiting the order of increasing complexity (stratomorphic series). In fact, he explains, it has only been within approximately the last 30 years that these rocks have been recognized as what they are- Precambrian sediments that did not erode away. Within this series, there is a clear and consistent sequence of sediments containing organisms increasing in complexity beginning with simple bacteria. This same order of increasing complexity in the fossil record is observed throughout the geological column. For example, the order is present even throughout the Great Unconformity (which exists on almost all continents) despite the fact that some of the layers present in the Precambrian series of sediments are missing altogether.

Dr. Wise supplies the following examples of this ascending complexity. In the deepest layer of sediment, the only fossils present are bacteria or bacteria related. Rising up into younger sediments, in addition to the bacteria, you begin to find single celled algae. Continuing upward, protists appear (single celled, non-photosynthetic organisms- not an animal, plant, or fungus). Next, appear a group called “Ediacaran Fauna” which are large (1-2′), flat macrofossils (fossils observable with the naked eye).

Photo: Dickinsonia, by Ilya Bobrovskiy, Australian National University (fair use for scientific and educational purposes), via SBS News.

Following this group is “Tommotian Fauna” (or “small shelly fauna”) which are small (around 1 inch at most) cone-shaped fossils.

Tommotian Fauna image via fossilmuseum.net

Next, come the “Atdabanian Fauna.” This is the lowest level in which Trilobites are found.

Plate from Barrande’s work Système silurien du centre de la Bohême via Wikipedia

Evolutionist Interpretation of the Data

Traditional evolutionary theory presupposes both uniformitarianism and naturalism. The former can be defined as the “concept that ‘the present is the key to the past’ (that events occur at the same rate now as they have always done)…Today, Earth’s history is considered to have been a slow, gradual process, punctuated by occasional natural catastrophic events.” Therefore, each layer of sediment in the geologic column (some of which are tens of thousands of feet thick) represents millions of years of history. This “deep time” is crucial to support the latter presupposition which can be summarized as the “idea or belief that only natural (as opposed to supernatural or spiritual) laws and forces operate in the world.” Barring the possibility of a Creator God existing outside of His Creation, evolutionists conclude that the ascending complexity of organisms can only be explained by slow evolutionary processes requiring millions of years.

No one would disagree that given the presuppositions above, these conclusions are reasonable. Wise notes an additional factor supporting evolutionary theory while being problematic for YEC. Essentially, if the lowest levels of sediment can preserve bacteria, it should be able to preserve more complex organisms if they existed simultaneously. The simplest and most logical deduction is that only bacteria are preserved because they were the only thing in existence. This is the problem Wise’s theory addresses.

At this juncture it must be noted that the assumption of uniformitarianism underlying evolutionary theory is not scientifically provable. As influential 20th century paleontologist G.G Simpson famously stated, “Uniformity is an unprovable postulate justified, or indeed required, on two grounds. First, nothing in our incomplete but extensive knowledge of history disagrees with it. Second, only with this postulate is a rational interpretation of history possible, and we are justified in seeking—as scientists we must seek—such a rational interpretation.” This is imperative due to modern day rhetoric claiming that creation science is “pseudoscience.” The entire foundation of evolutionary theory is underscored by an “unprovable postulate” rendering its resulting conclusions no more or less scientific than the conclusions of creation science.

YEC Interpretation of the Data

YEC’s operate under their own set of presuppositions. While agreeing that relatively recent geological history can be reconstructed with the assumption of the slow, gradual processes that we witness today, they reject that uniformitarianism can be projected infinitely backward in antiquity to arrive at an accurate historical reconstruction of earth’s ancient history due to the global Flood. YEC’s also presuppose a Creator who created life supernaturally as described in Scripture rather than via naturalistic means. Wise submits that the evidence indicates that “the uppermost Precambrian are the very beginning of the Flood deposits and they are preserving a Pre-Flood ecological sequence of some sort.”

Interestingly, this alternative interpretation of the data wasn’t arrived at by a group of YEC scientists. Instead, the theory that follows was developed during the course of a Harvard University graduate class under renowned paleontologist and evolutionary biologist Stephen Gould, studying the Cambrian explosion. Although Wise doesn’t reveal if any of the other class participants besides himself were YEC’s, he does note that the conclusions being drawn were (understandably) disconcerting to the evolutionists working on the project.

It all began when the group made an interesting observation: within the stratomorphic series,

each type of fauna is specific to a particular type of rock. For example: the Ediacaran Fauna is almost always found in sand; the Tommotian Fauna is always in carbonates; and the Atdabanian Fauna is always in shale. Therefore, the faunal sequence is dependent on the type of rock (facies dependant).

The group recognized this phenomenon to be in keeping with “Walther’s Law” which Wise summarizes as, “a principle in geology stating that if you have a series of lithosomes (types of rock) stacked vertically in a particular order, it could be that the order is due to a transgression event or a regression event, where the first thing is formed in shallow water, the next thing is formed in deeper water, and the next thing is formed in even deeper water. It could be that what you see vertically, is what the world was like horizontally at the time of deposition… So, you’re not actually looking at three different aged things. You’re looking at three different things at different positions.”

“Stratigraphic column on the north shore of Isfjord in Svalbard Norway. The vertical succession of rock types (representing sedimentary facies) reflects lateral changes in paleoenvironment.” via Wikipedia

Wise clarifies with the following scenario: you have sand at the shore, mud off shore, and reefs out beyond that. This would result in layers of sandstone, mud shale, then carbonate. So, if you see a sequence of sandstone/shale/carbonate in a vertical sequence, you could conclude that rather than life evolving into greater complexity over millions of years, you merely have three separate facies existing side by side that became buried on top of each other because water came in over the land. Therefore, these three faunas may not be separated in time, but are separated horizontally. Three different fauna, living at the same time, getting buried in a sequence only because water is either coming in or going out. Subsequently, the shallow water organisms are buried on bottom, followed by those inhabiting medium depth water, followed by deep water organisms.

This essentially reveals that millions of years of time is not a necessary factor in the formation of these 12 areas in which geologists have a clear cross-section of the Precambrian.

Adding Radiometric Dating into the Mix

It is beyond the scope of this article to address the numerous and very valid problems with the accuracy of ages of rocks assigned by radiometric dating. Interested readers can refer to Dr. Andrew Snelling’s treatment of that topic in his article Radiometric Dating: Problems with the Assumptions. To greatly simplify, I will merely state that the science behind the dating models is sound. However, the scientifically unprovable assumptions plugged in as constants in the equations render the results unrealiable at best and completely invalid at worst.

For our purposes, the only relevant issue is the range of time that these radiometric dating models indicate regarding the successive layers of rock which cumulatively result in the millions of years evolutionists assign to the geologic column in the form of the geologic time scale. When it comes to these ancient date ranges assigned to each layer of sediment, Wise explains that the smallest increment of measurement is the “radiometric pixel” which is a unit of 5 million years. Essentially, this means that radiometric dating methods employed in this context cannot discern periods of time between sediments in increments less than 5 million years.

This becomes of paramount importance when Wise notes that the graduate team examining the radiometric dating data pertaining to these layers of sediment discovered that the evidence revealed the time period separating these layers was not, in fact, hundreds of millions of years, but something less than a radiometric pixel! Here, Wise points out, that when you are at the Cambrian level (dated by the evolutionary time scale to be 5 million years ago), 5 million years is 1%- you can’t see anything less than 1%. Foundationally, you can’t distinguish the different age of things less than 1% apart.

How do these facts alter the interpretation of the data? Wise states, “The radiometric data suggests that there is less than a radiometric pixel between these three faunas. Add that to the facies issues of the faunas and we concluded these faunas don’t represent successive faunas, they represent three faunas at the same time. Buried in that order, but not living in that order.”

Wise continues by explaining that this finding is magnified when one realizes that whatever process has buried these fauna in this same pattern, it is represented identically in 12 different geographical locations all over the earth! So, the next step becomes figuring out how closely the age of these 12 different deposits can be determined. Wise says, “Again, we concluded that we cannot discern differences in their age at the level of the radiometric pixel. So, they could all be at exactly the same moment in time, and that the same event, a global event, buried them in the same sequence for that reason.” Therefore, the data contained in the Precambrian and lower Cambrian layers can very well be interpreted in support of the Genesis global flood event, documenting life existing simultaneously, and ordered in horizontal proximity to one another.

Conclusion

At the end of the day, evolutionists will never consider the YEC theory to be valid. Not because the data contained in the Precambrian and lower Cambrian sediments preclude it, but because it violates the two foundational presuppositions of uniformitarianism and naturalism- neither of which are scientifically provable.

 

 

Orphan Genes Part 3: De Novo Gene Origination- What are the Odds?

In Part 1 of this series we discussed the discovery of orphan genes and in Part 2 we tracked evolutionist response: initial rejection of their possible existence transitioning into reluctant acceptance due to repeated undeniable confirmation. Since evolutionists operate under the assumption that evolution is true, this acceptance necessitated a response regarding proposed naturalistic methods for the origination of these genes which evolution requires to emerge “de novo” (or “from scratch”) into the genome. The plausibility of these propositions will be the focus of the final installment of this topic.

A Trip Down Memory Lane

It’s not as if the methods by which genetic diversity manifest in the genome had never been considered. The reluctance of evolutionary science to embrace the existence of orphan genes is completely understandable given the historical conclusions drawn regarding de novo gene origination. A giant in his field (Head of the Dept. of Cell Genetics at Institut Pasteur in 1960 and 1965 Nobel Prize in Physiology or Medicine winner), Francois Jacob, emphatically denounced de novo gene origination in his 1977 work Evolution and Tinkering:

Evolution does not produce novelties from scratch. It works on what already exists, either transforming a system to give it new functions or combining several systems to produce a more elaborate one.” He continued, “The probability that a functional protein would appear de novo by random association of amino acids is practically zero. In organisms as complex and integrated as those that were already living a long time ago, creation of entirely new nucleotide sequences could not be of any importance in the production of new information.” (emphasis mine)

Francois Jacob (via Wikipedia)

A Second Look at the Junk Pile

Confronted with new facts, evolutionists turned to re-examine what they had previously considered a DNA garbage heap. The majority of DNA (99%) is non-coding, meaning that it doesn’t provide instructions for making proteins. As this NIH article explains:

Scientists once thought noncoding DNA was ‘junk,’ with no known purpose. However, it is becoming clear that at least some of it is integral to the function of cells, particularly the control of gene activity. For example, noncoding DNA contains sequences that act as regulatory elements, determining when and where genes are turned on and off. Such elements provide sites for specialized proteins (called transcription factors) to attach (bind) and either activate or repress the process by which the information from genes is turned into proteins (transcription).”

According to the same source, types of regulatory elements found in junk DNA include promoters, enhancers, silencers, and insulators. Since the revelation that this junk DNA is not actually useless is fairly recent, it’s not surprising that “the identity of regulatory elements and other functional regions of noncoding DNA is not completely understood.”

Proposed Models

How could this “junk” DNA give rise to de novo origination of genes? This McLysaght/Guerzoni study concludes:

We may thus imagine two scenarios: one where an arbitrary ORF appears in a locus of significant transcription (‘RNA first’) and one where a cryptic, arbitrary ORF experiences some low, perhaps sporadic, transcription (‘ORF first’).”

The authors go on to state, “Either way, evolutionary tinkering with this pool of genetic potential may have been a significant player in the origins of lineage-specific traits and adaptations.”

Of course, these conceptual models derive from what Dr. Kevin Anderson (writing for AIG) terms “historical reconstructions” which by their very nature “are only as good as the assumptions of the reconstruction.” In this case the assumption is evolution via mutation. No other possibility is considered.

Emily Singer writes in her article for Quanta, “The junk DNA must accumulate mutations that allow it to be read by the cell or converted into RNA, as well as regulatory components that signify when and where the gene should be active. And like a sentence, the gene must have a beginning and an end…In addition, the RNA or protein produced by the gene must be useful.”

What are the Odds?

Possibility is one thing. Plausibility is entirely another. On the likelihood of such a scenario occurring Singer notes, “…creating a gene from a random DNA sequence appears as likely as dumping a jar of Scrabble tiles onto the floor and expecting the letters to spell out a coherent sentence.”

If these are the odds of even one gene emerging de novo from junk DNA, what then must be the odds of such an event taking place over and over in every living species? Furthermore, trends indicate that scientists may merely have uncovered the tip of the iceberg when it comes to the number of de novo genes. Singer writes, “As scientists…are implementing new gene discovery technologies…the number of de novo genes might explode.”

More Problems…

Statistical improbability isn’t the only issue with de novo gene origination via mutation. Dr. Anderson writes, “If it takes at least seven mutations to transform a functional gene into a different gene, then it would require far more mutations to truly evolve a de novo gene…the more mutations required, the greater the potential that some will be harmful. Evolutionists recognize this issue as well. Joanna Masel, a University of Arizona biologist studying how evolution might avoid this pitfall, explains: “Proteins have a strong tendency to misfold and cause havoc. It’s hard to see how to get a new protein out of random sequence when you expect random sequences to cause so much trouble.”

Closely related to the issue of mutations is the amount of time it would take these mutations to result in the de novo emergence of a gene. Dr. Anderson writes, “…the time needed to transform a functional gene into a different gene bursts the evolutionary timescale. The de novo formation of new genes takes this problem to even greater magnitudes. Humans, for example, are supposed to have evolved from a primate ancestor in just 4–6 million years. Even by the most generous calculations, this is insufficient time for the de novo construction of the hundreds of human orphan genes.”

De novo gene origination is just one piece of the puzzle. Singer poses the next, equally confounding question: “how de novo genes get incorporated into the complex network of reactions that drive the cell.” And that’s not the only concern, “Evidence suggests that a portion of de novo genes quickly become essential. About 20 percent of new genes in fruit flies appear to be required for survival.” She continues, “It’s as if a bicycle spontaneously grew a new part and rapidly incorporated it into its machinery, even though the bike was working fine without it.”

Conclusion

Evolutionists routinely disparage creation science by labeling it pseudoscience and calling foul based on Biblical bias. However, the case of orphan genes is an excellent example of the hypocrisy of such a claim. Secular science operates under its own bias- faith in evolution. Dr. Anderson aptly describes the evolutionist view of de novo gene origination, “This conclusion is not based on observational data, but rather on evolutionary necessity. The presumption of evolution is so prevalent in biology that it trumps everything else, even if it means depending upon events with a ‘practically zero’ chance of occurring.”

While orphan genes are definitely a wrench in evolutionary theory, Dr. Anderson notes that orphan genes fit “within a biblical creation model, where humans, animals, plants were created with a fully functional genome. Since this initial creation, subsequent changes in the genome have introduced many mutations and other alterations to the DNA. Some of these have even provided a specific (and likely limited) adaptive benefit. Yet these benefits result from degenerative mutations, not the formation of new genes.”