Managing Editor's Note: We first ran this post on June 12, 2008.
By J.B. Handley
Critics have noted a change in our community’s perspective on the relationship between vaccines and autism from a singular focus on mercury to a broader focus on the entire vaccine schedule, including both the total number of vaccines our kids receive and how early and often they are given. The gripe is that we have “moved the goalposts” in terms of defining what happened to our kids because the Thimerosal theory, according to critics, is dying on the vine.
Characterizing the expansion of scope by saying we have “moved the goalposts” insinuates that this is some sort of game and that we are somehow cheating. Anyone respectful of the importance of the evolution of hypotheses would concede that identifying the cause of autism is not a one-shot deal where you have to abandon all other theories if the first theory proves to be too narrow. The goal is not to be perfectly right the first time but rather to figure out why so many of our kids are sick and what we as a community can do about it.
A harebrained theory?
Both Dr. Bernadine Healy, the former President of the NIH, and Dr. Jon Poling, a neurosurgeon whose daughter won the first case from the US Government conceding vaccines caused her autism, acknowledged that when they first heard of the vaccine-autism theory they were dismissive and didn’t take it too seriously. In the case of Dr. Healy, she took the time to read the research for herself. In the case of Dr. Poling, he witnessed his daughter disappear after a single visit to the pediatrician where she received 9 vaccines.
In the mainstream press, the vaccine-autism theory is often explained away as having evolved solely because the emergence of autism and the timing of vaccines happen to be correlated -- nothing more than an unfortunate coincidence.
Consider, however, the straightforward fact pattern that many of us have used in concluding vaccines triggered our child’s autism:
1.There are tens of thousands of separate case reports of parents getting their child vaccinated, the child having a reaction to the vaccines, and soon after developing autism.
2.The vaccine schedule has ballooned from 10 vaccines by the age of 5 in the early 1980s to 36 today. During this time, autism’s prevalence is up 60-fold, from 1 in 10,000 to 1 in 150. This is either an unfortunate coincidence (correlation does not necessarily mean causation) or a cause-and-effect relationship.
It’s worth noting that some still assert that the rate of autism has not actually increased, it’s simply a product of better diagnosis and expanded criteria. This assertion obscures the debate and serves the interests of anyone who does not want the cause for a rising rate of autism identified, since a rising rate cannot be explained genetically. The notion that “autism has always been with us” is misinformation, nothing more. No scientific body has ever been able to find an adult population of autistics with anywhere near the prevalence of autism as children born in the last 15 years. And, consider this summary from a report in California, the state considered to keep the best track of autism cases:
"There is no evidence that a loosening in the diagnostic criteria has contributed to increased number of autism clients...we conclude that some, if not all, of the observed increase represents a true increase in cases of autism in California...a purely genetic basis for autism does not fully explain the increasing autism prevalence. Other theories that attempt to better explain the observed increase in autism cases include environmental exposures to substances such as mercury; viral exposures; autoimmune disorders; and childhood vaccinations."
3.Perhaps most damning, and rarely reported by the mainstream press, is this vaccine injury table from our own Department of Health & Human Services, the oversight agency for both FDA & CDC. As the website explains, “The Table lists and explains injuries/conditions that are presumed to be caused by vaccines.”
The Table was developed based on known side effects from vaccines and is used to compensate victims of vaccine injury. One of the many potential side effects of vaccine injury, as the website spells out, is “chronic encephalopathy” which is defined as when “a change in mental or neurologic status, first manifested during the applicable time period, persists for a period of at least 6 months from the date of vaccination.”
We have tens of thousands of case reports of parents reporting their children descended into autism after vaccines, a tripling in the number of vaccines given to children in the last twenty years during a time when the rate of autism has skyrocketed, and a Table created by our own government that explicitly states that neurological disorders are a side effect of vaccines. Is it that hard to understand why parents believe vaccines may have caused their child’s autism?
Starting with Thimerosal
The “Mercury Militia” as our community is sometimes derisively referred to, was ironically created by the FDA through their Modernization Act of 1997 which “called for the FDA to review and assess the risk of all mercury containing food and drugs.”
At 4:15 pm Eastern time on a Friday afternoon in July 1999, a joint statement by the AAP and Public Health Service was released to the press advising Americans that the amount of mercury in vaccines administered to children, through a preservative called Thimerosal, exceeded Federal Health guidelines. The statement did not reveal the amount of panic, back door negotiating, and concern federal health officials had been engaged in for the past few weeks, after the levels of mercury had been calculated by dumbfounded federal officials reviewing submissions from vaccine manufacturers responding to this broad FDA inquiry regarding mercury in consumer products. While this article from Pediatrics ultimately looks at the policy makers favorably, it does help explain how frenetic the process was. An excerpt from the statement:
“The recognition that some children could be exposed to a cumulative level of mercury over the first six 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 neuro-developmental 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 six months of life. Nevertheless, because any potential risk is of concern, the Public Health Service, the American Academy of Pediatrics, and vaccine manufacturers agree that Thimerosal-containing vaccines should be removed as soon as possible. Similar conclusions were reached this year in a meeting attended by European regulatory agencies, the European vaccine manufacturers, and the US FDA which examined the use of Thimerosal-containing vaccines produced or sold in European countries.”
The joint statement above downplayed the risk of mercury injected in newborns, and it downplayed the degree to which mercury exceeded federal safety standards. Doing the simple math, a child following the recommend schedule and receiving vaccines at birth, 2 months, 4 months, and 6 months was receiving mercury in excess of the EPA safe standards by a factor of 36x, 120x, 77x, and 66x, respectively. That's 120 times the safe Federal standard. (See chart HERE.) Also, as mentioned above, the start of the sharp increase in autism and other neurodevelopmental disorders matches the change in the vaccine schedule. In the 1980s the incidence of autism was somewhere between 1 in 10,000 and 1 in 5,000, today it is 1 in 150. (See chart HERE.)
If you were a parent with a child with autism in 1999 who had watched your child descend into autism after vaccination, this Joint Statement rocked your world. Firstly, the Internet was not in widespread use like it is today, which means you were unlikely to be aware of the thousands of other parents who had the same experience you had with vaccines and autism. Also, sharing your belief that vaccines caused your child’s autism was likely met with ridicule by your pediatrician and community in general. To hear that mercury, a potent neurotoxin, was actually in your child’s vaccines was new and shocking information. If you took the time then, to read the MSDS on Thimerosal, your shock would likely increase:
“Exposure Guidelines: Thimerosal - no known occupational limits established...Exposure to mercury in utero and in children can cause mild to severe mental retardation and mild to severe motor coordination impairment...Use of chelating agents such as BAL may be needed to treat ingestion of mercury...Target Organ Effects: Mercury - Nervous system effects (insomnia, tremor, anorexia, weakness, headache), liver effects (jaundice, digestive effects (hypermotility, diarrhea).”
We have parents in 1999 certain their child descended into autism after receiving vaccines, we have a joint statement from the public health service and AAP warning that mercury in vaccines exceeds federal safety guidelines, and you have an MSDS on Thimerosal that states it can cause “mild to severe mental retardation and mild to severe motor coordination impairment.” It seems a parent pursuing the possible correlation between Thimerosal and their child’s autism is following a clear and logically derived fact pattern.
What’s interesting to note about the time around 1999, and what also remained true when my son was born in 2002, is that there was very little focus on the expansion of the vaccine schedule in general that had taken place since 1986, when Congress indemnified vaccine manufacturers from liability. The schedule had grown from 10 vaccines to 36 vaccines by the age of 5, and vaccines were being recommended to be given earlier in a child’s life, and in much higher combinations at a single visit. The notion of a “combination risk” from so many simultaneously administered vaccines was rarely discussed.
A Quick History
It’s impossible to understand how we go to where we are today without taking a look at the history of what got us here. In particular, my discourse will focus on two studies that serve as the backbone of our public health authorities’ case that vaccines do not cause autism:
1. As it commonly known, the “Danish Study” published in Pediatrics In September 2003, Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data (HERE.)
2. The CDC’s analysis of American data, and the only American data ever analyzed in this entire debate, also published in Pediatrics two months after the Danish Study, titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organizations. (HERE.)
Stick with me, this is a bit of an earful, but it helps explain how the “science” the other side uses today to defend themselves was manufactured.
Soon after the joint statement by the AAP and Public Health Service was released, all hell broke loose, and the CDC moved into damage control mode, where they remain today, nine years later. (Here's a great ARTICLE from the Hepatitis Control Report on the panic.) Parents (HERE) of autistic children began to compare the symptoms of autism to the symptoms of mercury poisoning, and a feisty Congressman from Indiana with an autistic grandson, Dan Burton, started using his pulpit as head of the Committee on Government Reform to ask very tough questions. By August, two months after the joint statement, his committee was in a full-scale investigation of conflict in vaccine policy, which the CDC knew.
(Shockingly, CDC received letters in July and September 1999 from Merck (HERE) and SmithKline Beecham (HERE) respectively, letting CDC know that full production of Thimerosal-free vaccines for Hepatitis B and DTaP could be made available almost immediately. To SmithKline, CDC (HERE) responded with a tepid letter thanking them for the offer, but not taking them up on it. Thimerosal would remain in the vaccines on the Childhood Immunization Schedule for three more years, into late 2002, before Thimerosal-free vaccines were finally available for all vaccines, as this letter from FDA (HERE) to Congressman Dave Weldon demonstrates. CDC's inexplicable complacency in the face of the July 1999 statement to switch over to Thimerosal-free vaccines was highlighted in this March 2006 article (HERE) by Robert F. Kennedy, Jr. in the Huffington Post. That the overwhelming majority of flu vaccines still today contain Thimerosal and that flu is now a recommended vaccine is incomprehensible, but true.)
As part of the FDA Modernization act that spurred the joint statement, FDA was required to commission the Institute of Medicine to review the impact of mercury in vaccines. The IOM's study began in late 1999 with an expected publication date in 2001. For the CDC, the walls were starting to close in. The knowledge of a looming IOM review spurred CDC to take matter into their own hands.
Soon after the AAP statement a young CDC epidemiologist, Dr. Thomas Verstraeten, was given the task of comparing neurodevelopmental outcomes of children exposed to Thimerosal using the CDC's internal database, the Vaccine Safety Datalink (VSD). CDC hoped to run their own analysis, establish no relationship between Thimerosal and autism, give the analysis to the IOM, and close this chapter for good. By November of 1999, just 5 months after the joint statement, Dr. Verstraeten was in a near panic as the data he was analyzing was showing a clear, unassailable, ugly truth: there was a statistically significant relationship between the amount of mercury children were receiving through their vaccines and autism. No matter how he tried to run the numbers, he wrote, the association "just won't go away."
In June of 2000, six months after Dr. Verstraeten's analysis revealed a clear correlation, the CDC commissioned a private meeting at the Simpsonwood Conference Center in Atlanta, GA, with representatives from the CDC, other health organization (WHO, FDA) and representatives of vaccine manufacturers to share some startling news: despite six full months of trying to dumb down the data, CDC's analysis was still showing a statistically significant relationship between neurodevlopmental disorders, especially autism, and Thimerosal children received through their vaccines.
The Simpsonwood meeting set that stage for the way the CDC has conducted themselves ever since: control the damage, bury the data, and ensure that the National Immunization Program never misses a beat. The candor and incriminating statements of the Simpsonwood attendees is at times breathtaking, and a whole website could be devoted to analyzing the words of the participants. A great summary of the Simpsonwood meeting is available through this excellent article (HERE) written by Dr. Russell Blaylock. The transcript (HERE) from the meeting was stamped with the words "Do Not Copy or Release" and "Confidential", but was obtained by parents through FOIA.
Late 2000 and 2001 was a rough time for the CDC. Simpsonwood had already highlighted the challenges CDC faced with the data they were sitting on. In August of 2000, two months after Simpsonwood, Dan Burton's Government Reform Committee released a highly critical document (HERE) on the conflicts of interest at CDC and FDA for decision made on the Rotavirus vaccine, recently recalled due to intussusception in children (a severe bowel disorder), and critical of vaccine policy making in general.
In January 2001, parents associated with the nonprofit group SafeMinds published an article in a peer-reviewed journal titled Autism: A Novel Form of Mercury Poisoning (HERE.) Chairman Burton continued to hold hearings, browbeating public health officials over the lapse on Thimerosal and what was being done about it. This was followed up that May by a speech (HERE) by Chairman Burton demanding FDA recall any vaccine containing Thimerosal at once (they didn't).
Once it was clear that unsafe levels of mercury were in the vaccine supply, FDA was required to hire the Institute of Medicine to review Thimerosal and any role it may play in damaging children. With the weight IOM carried with the scientific community, IOM's conclusions, expected to be published in late 2001, were of grave concern to CDC. By the summer of 2001, CDC was aware of IOM's likely conclusion, which was not particularly favorable to CDC: they were going to say that the notion that Thimerosal created neurological disorders was "biologically plausible" and merited further study. CDC had already given IOM their data from the VSD, which had been manipulated enough to neither prove nor disprove an association. From the final IOM Report in 2001:
"The Committee concludes that although the hypothesis that exposure to Thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established and rests on indirect and incomplete information, primarily from analogies with methylmercury and levels of maximum mercury exposure from vaccines given in children, the hypothesis is biologically plausible." - October 2001, Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders, Institute of Medicine
Perhaps most frustrating about the recommendations of the IOM Report in October 2001 is that CDC did not pursue any of them. Where IOM recommended further work to assess biologically plausibility (like measuring mercury levels in autistic children), CDC would focus exclusively on epidemiology, a statistical science easily manipulated. Where IOM encouraged CDC to explore the growing reports of autistic children recovering after chelation therapy, a treatment to remove mercury and other metals from the body, CDC never did anything to explore the reports further. Where IOM encouraged CDC to replace any Thimerosal containing vaccines immediately, CDC still has vaccines with Thimerosal targeted at infants today, seven years later.
CDC was in a bind. They knew what the Generation Zero data had shown and how explosive that information, if released, would be to the National Immunization Program, their jobs, and vaccine manufacturer liability. They also knew IOM was not going to let them off the hook, and that more work and analysis would be recommended. It left only two alternatives for CDC, both of which they continue to follow today:
- Never, ever let anyone else see the Generation Zero data (the original data that showed a relationship that would not go away) nor any of CDC's other internal data. Given all the shortcuts and assumptions CDC made to manage down the risks, independent researchers would most assuredly come to a different conclusion. Even though laws required CDC to share this data publicly, they would become experts at buying time and "losing" data when pressured.
- Since the U.S. data shows a high correlation, go to other countries and find willing participants to manufacture data that will "prove" Thimerosal and autism are unrelated.
With that strategy in place, a few months prior to the release of the IOM study, CDC employees, under the guidance of their bosses, Dr. Walter Orenstein, Director of the NIP and Dr. Roger Bernier, Associate Director of Science for the NIP, began a world-wide inquiry to find data from other countries that would be used bail them out. Not only would CDC initiate, fund, and structure these studies, but their own employees would also end up as published authors in the studies exonerating Thimerosal's role in autism.
CDC's effort, beginning in the summer of 2001, was in anticipation of the IOM's report (HERE) coming out in the October 2001. They knew what it was going to say and they knew it was going to be trouble. The CDC's subsequent worldwide effort was an attempt to find corroborative data showing no link between autism and Thimerosal and get it to the IOM or release it at the same time as the IOM report was released. As Dr. Diane Simpson says in this August 7, 2001 email (HERE):
"I don't have any new data at the moment and am frantically trying to see what is available and how best to get it in time for the expected IOM report release (we have given up trying to submit it in time for the report as they are in the process of writing it)."
Dr. Simpson's actions beginning in June of 2001 require some context. The Deputy Director of the NIP, Dr. Simpson, was given the task of finding data on autism and Thimerosal in other countries. And not just any data, she was looking for data that would support no relationship between mercury and autism, despite the fact that they had both seen the Generation Zero data and both attended Simpsonwood. Further, you have the division of the CDC that is responsible for keeping vaccination rates high, the division that would be held most responsible for creating the autism epidemic, and one of the leaders of that division, Dr. Robert Chen, who had the most to lose, directly involved in a process to find data about the relationship between Thimerosal and autism.
Would CDC be "frantic" to find data that would corroborate the conclusion coming from IOM, that the Thimerosal-autism relationship was "biologically plausible"? No, she was frantic to find data to disprove it. In the same month, she tells a Swedish researcher in this email (HERE) that they could fly to Sweden immediately to look at data, "because our IOM committee's work is in process and we expect them to issue their report in the next several weeks, we expect increased public concern and questions in the near future." In an email (HERE) with another CDC employee, referring to data she may have unearthed in Denmark, she writes, "it is also possible that the data won't help us at all, but we won't know until we see it." How won't it help? It won't help unless it can be used to exonerate Thimerosal and the CDC.
As an example, Dr. Simpson's communication with the State of California (where autism data is the best in the country) produced a stunning data set, and one quickly buried. In this email (HERE) we see data provided by Dr. Loring Dales from the California Dept of Health showing the relationship between the vaccination rates of DTP by second birthdays, and the number of autism cases in California. One of Dr. Simpson's colleagues mentions "this looks like material for a graph." The graph is created, page 3 of the email, and there is a clear, linear relationship between the increase in vaccination rates (from 50.9% to 75.7%) and the number of autism cases per year (from 176 to 1182, a 6.7x increase) between 1980-1994. Needless to say, California was not the source of additional follow-up.
Dr. Simpson was an interesting choice to lead this initiative. She was oblivious to the full-blown epidemic of autism, as this email (HERE) on June 8, 2001 shows:
"I have seen statements claiming huge increases in the incidence rate of autism in the US over the past 10-15 years. The only data I have seen from California. Are there national estimates for autism in the US or is everything extrapolated from the California data?"
Nonetheless, Dr. Simpson began her search, as introductory emails to California (HERE), Sweden (HERE), Belgium (HERE), and Denmark (HERE) show, Dr. Simpson's goal, through her emails, was very clear: exonerate Thimerosal. Not all of Dr. Simpson's correspondence was well received, and in fact some of it was quite comical. A Swedish Doctor, Dr. Marta Granstrom, responded in this email (HERE) to Dr. Simpson with a clear point of view on Thimerosal:
"I am very well aware of the recent concerns in the US over thiomersal (an alternative name for Thimerosal). On the expert committee of the European Pharmacopoeae I represent Sweden and had in vain tried to get Europe to ban its use in single dose vials until the US interest in the issue...I thanked Neal Halsey [AAP member who spearheaded the joint statement in 1999] in the name of European infants for the help when I met him again last year."
By August, Dr. Simpson was getting desperate as she lamented in an email (HERE) that, "events have slightly accelerated with Walt's return [Walter Orenstein, Director of the NIP] and anxiety over trying to get these data. Consequently, we are TENTATIVELY planning for you and I to go to Denmark and Sweden on August 22...if a trip is to occur in time for the IOM it has to be in this time frame." In many ways, the trip to Sweden and Denmark was Dr. Simpson's last shot at finding data, as her August 6 email (HERE) shows:
"Should we find that any other country has good data on both autism and vaccines, we will work to get that data on a case by case basis. i.e., I don't know what we are going to do and don't want to think about it right now- but we will do something."
The "something" Dr. Simpson did was find a Danish vaccine company, Status Serum Institute, willing to work with CDC. A company who sold Thimerosal-containing vaccines and a company who would soon see an enormous rise in the number of vaccines sold to the United States. Along with her colleague, Dr. Paul Stehr-Green, Dr. Simpson was heading to Denmark. Two years later, Dr. Simpson and Dr. Stehr-Green would be published authors, along with employees of SSI, letting the world know that the “Danish Study” proved that Thimerosal does not cause autism. These Danish studies would then form the basis for a NEW IOM, initiated by CDC, that in 2004 would declare that the Thimerosal-autism hypothesis was without merit, and has since been referenced as "proof" that Thimerosal is safe. It all started with Dr. Diane Simpson's trip to Denmark.
(Separately, in 2002, the CDC outsourced the maintenance and analysis of the Vaccine Safety Datalink database to a private lobbying organization that represents health insurance companies, America's Health Insurance Plans (HERE) in a contract valued at more than $190 million. This private outsourcing of government data, contracted in the midst of the furor over the CDC's mishandling of Thimerosal-autism data, has served to insulate VSD data from the Freedom of Information Act ever since. As of today, no outside scientists have been able to review the American data CDC used to exonerate Thimerosal.)
The Mercury In Medicine report (HERE) from Chairman Burton's Committee on Government Reform, was released in May 2003, and provided a scathing indictment of the Federal Health bureaucracy and their inexplicable complacency regarding mercury and vaccines. Despite the entire report being publicly available in the Congressional Record, it has gotten little publicity. An excerpt:
"Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely. Manufacturers of vaccines and Thimerosal, (an ethlymercury compound used in vaccines), have never conducted adequate testing on the safety of Thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on Thimerosal and ethlymercury compounds...Thimerosal used as a preservative in vaccines is likely related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding injected Thimerosal and the sharp rise of infant exposure to this known neurotoxin. Our public health agencies' failure to act is indicative of institutional malfeasance for self-protection and misplaced protectionism of the pharmaceutical industry" - Mercury In Medicine: Taking Unnecessary Risks, Committee On Government Reform, U.S. House of Representatives, May 21, 2003
While the Mercury In Medicine report was certainly not welcome by CDC, they knew that by the Fall of 2003 the pendulum would swing back towards exonerating Thimerosal with the near simultaneous release of four separate studies between September and November in four separate medical journals that would provide the basis for "proof" that vaccines and autism are unrelated as cited by the IOM six months later in their 2004 report. Three of those studies, in Pediatrics (HERE) The Journal of the American Medical Association (HERE) and The American Journal of Preventative Medicine (HERE) would be based on the Danish data, and one study, also in Pediatrics (HERE) would be the data finally released by CDC of their analysis of the VSD.
For practicing Doctors, medical journals are their primary source of information from the outside world. For pediatricians, tasked with administering the lengthy U.S. Immunization Schedule (HERE) Pediatrics, the Journal of the American Academy of Pediatrics, is their trusted source of information. I believe few pediatricians are remotely aware of the conflicts, limitations, and manipulation that the published studies were subjected to, and that few realize many of the published authors were CDC employees or SSI employees, a Danish vaccine manufacturer.
A Foundation of Sand: The Danish Study and CDC Data
As I mention, because Pediatrics is the trusted source of information for Doctors, and because the two Pediatrics studies are most often cited regarding "proof" that vaccines do not cause autism, I will focus on analyzing these two:
In September 2003, Pediatrics published Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data (HERE.) Thimerosal was removed from Danish vaccines in 1992, and the study showed that not only did autism rates not go down after its removal, they actually went up. The study's lead other, Kristeen Madsen, had been one of the Danish researchers Dr. Diane Simpson reached out to early on in her world travel of 2001. This study was highly flawed for the following reasons (read SafeMinds' critique here HERE):
"The data as it was captured was blatantly obscured. The study looked at data between 1970-2000. In 1995, the Danish registry added "Outpatient Clinics" to their count of autism cases. It turns out that Outpatient Clinics are where 93% of Danish children are diagnosed with autism, so the number of autism cases before 1995 did not include the clinics. More surprising, the authors even note this in the study: "since 1995 outpatient activities were registered as well...the proportion of outpatient to inpatient activities was about 4 to 6 times as many outpatients as inpatients...this may exaggerate the incidence rates."
Exaggerate the incidence rates? It is the equivalent of doing a study on "Divorce Rates in North America" and counting Mexico and Canada only for the first few years, then adding in the United States, and noting that divorce rates went up. As a SafeMinds critique of the study noted, "Therefore, their purported increase after 1994 can be explained entirely by the registration of an existing autism population that did not require hospitalization." To compound the problem, Denmark also changed the diagnostic code they used, to the more universal ICD10 code, beginning in 1993, which would have further raised the rates.
Dr. Madsen, in his communications with Dr. Diane Simpson two years earlier, actually noted this discrepancy in Danish data in an email (HERE) exchange:
Dr. Simpson: "Did they [autism rates] increase after 1993??"
Dr. Madsen: "Yes but not very dramatically and there could be more reasons for that. First of all we had a change from ICD8 to ICD10 in 1994 and furthermore our outpatient clinics were registered in our surveillance from 1995."
The rates of autism in Denmark and the number of vaccines and amount of mercury received in children are markedly lower than the U.S. Danish children receive 75% less Thimerosal than American children, they receive immunizations when they are older, and the U.S. autism rate is TEN TIMES the rate of Denmark (Denmark is 1 in 1,600, U.S. is 1 in 166). As an example, here is an email (HERE) exchange back in 2001 discussing data from Great Britain between Dr. Verstraeten, the author of the CDC's internal analysis, and Robert Chen. Dr. Verstraeten notes that the British numbers will probably not be helpful because the Thimerosal received by British children is too low relative to American children: "The maximum exposure is indeed relatively low...it may not be worth doing this after all." Denmark's Thimerosal was as low or lower than Britain, but they proceeded with the study anyway.
The study authors were conflicted, and the conflicts were not reported in the study, as they should have been. Of the seven co-authors of the study, three had received direct funding from the CDC on vaccine-safety related projects. One of the authors, Poul Thorsen, was a CDC employee. And, two of the authors were employees of Statens Serum Institute, a Danish vaccine manufacturer. Here's SSI's Annual Report (HERE.) Interestingly, page 28 shows that sales of vaccine products to the U.S. were particularly high in 2002. None of these conflicts are mentioned anywhere in the study.
CDC actual wrote a letter to Pediatrics recommending publication of the study. This letter (HERE) written prior to the official date of submission, reveals how involved in the study CDC was (remember, one of their employees was a co-author). Jose Cordero, Director of the Division of the CDC responsible for developmental disabilities, oversees the CDC's efforts to fight autism. He notes, "its findings provide one strong piece of evidence that Thimerosal is not causally linked to autism." Dr. Cordero, too, had seen the Generation Zero data and attended the meeting in Simpsonwood.
Two months later, Dr. Vestraeten's data, which began with a panic in late 1999 ('It just won't go away"), was published in Pediatrics titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organizations (HERE.) Perhaps most frustrating about this study is that it is often referenced as "proof" that vaccines do not cause autism when it was actually a neutral-outcome study, as Dr. Verstraeten himself noted, in a frustrated letter he wrote to Pediatrics (HERE):
"Surprisingly, however, the study is being interpreted now as negative [where 'negative' implies no association was shown between Thimerosal and autism] by many...The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come...A neutral study carries a very distinct message: the investigators could neither confirm nor exclude an association, and therefore more study is required."
This study was highly flawed for the following reasons (read SafeMinds' critique HERE):
The data was manipulated to remove the strong correlation between mercury and autism. As discussed, the initial analysis using Vaccine Safety Datalink data (VSD) showed a high correlation between Thimerosal and autism, called "Generation Zero." The CDC used many techniques to dumb-down the numbers including removing comparisons to children who had received no Thimerosal, lowering the age of children available for the analysis, and including a bankrupt HMO, with notoriously faulty data systems, in their final round of analysis. This HMO helped neutralize the findings reviewed at Simpsonwood. As SafeMinds reported:
"The general drift of their design changes was clear, to reduce the statistical power through conscious manipulation of statistical methods, data classifications, and samples."
Dr. Verstraeten, the study's author, had been an employee of Glaxo SmithKline for more than 2 years by the time the study was published. This blatant conflict, with a study author employed by a company being sued by parents for Thimerosal in vaccines, was never noted in the Pediatrics study.
Even with all the manipulation, the study was still a neutral outcome study!!! Many people would be surprised to know that the study itself cites a correlation between Thimerosal-containing vaccines and both "tics" and "language delay." Beyond that, the study neither proves nor disproves an association between Thimerosal and autism and recommends that more work needs to be done. It’s hard to understate how many misstatements our public health authorities have made about the actual conclusion of this study. It has never been demonstrated, with American data and American children that mercury and/or vaccines do or do not cause autism!
Asking the Wrong Questions
On a topic as confusing as vaccines and autism, our health authorities have been prone to make sweeping statements in the press, knowing that the risks of a reporter checking the details will be extremely low. They repeat ad nauseum in the press that “well designed large scale epidemiological studies have consistently shown no association between vaccines and autism.” I assert that this statement has absolutely no basis in fact.
Let’s look at what is actually known today, versus the hyperbole and exaggeration our health authorities use to reassure the public:
1. We know that a Danish Study, using a blatant and straightforward statistical trick that a fifth grader could identify as dishonest, showed that removing Thimerosal from vaccines did not lower the rate of autism of Danish children.
2. Using American data, and only comparing children who received more mercury with children who received less mercury, we have a neutral conclusion, which means no association could either be found or not found.
Folks, that’s it. That’s the basis for all the blanket assertions we read every day in the press that scientists have proven no association.
It’s stunning, it’s maddening. You can’t help but feel, when you read these sweeping statements, that one of two things is true:
1. The person making the statement has never independently verified what they are saying and is simply parroting the words of others before them
2. They are lying
Asking the Right Questions
Perhaps most maddening in watching the extreme scientific dishonesty that has taken place to defend the national vaccine program is that we are no closer to the far larger and more important question that every parent wants to know: do vaccines play a role in triggering autism?
The two studies above, even with their extreme flaws and neutral conclusions, only contemplate whether a single ingredient in vaccines—mercury—plays a role in autism. In every case, the children studied were ALL FULLY VACCINATED.
It’s hard to understate how limited the scientific information we have today on the vaccine-autism hypothesis really is. Imagine another scenario like the Firestone Tire-Ford Explorer fiasco of a few years ago. Imagine cars are flipping over and everyone thinks it’s the tires. So, a study is done that concludes, “It’s not the tires.” And, the cars are still flipping over. Do you stop looking for an answer?
In the case of autism, that’s exactly what has happened. Health authorities crafted the most narrow, one-sided epidemiological studies they could get their hands on and rushed them to print. When the final conclusion of American data, a neutral outcome, didn’t suit their needs, they just glossed over that and have ever since chosen to mischaracterize the findings in the press while looking to data in other countries that they can use. It’s breathtakingly immoral and unbelievable.
If you have actually made it to this point in my essay, perhaps you better understand the words of Bernadine Healy, MD, former President of the NIH, from an article written by CBS News:
“According to Healy, when she began researching autism and vaccines she found credible published, peer-reviewed scientific studies that support the idea of an association. That seemed to counter what many of her colleagues had been saying for years. She dug a little deeper and was surprised to find that the government has not embarked upon some of the most basic research that could help answer the question of a link.
The more she dug, she says, the more she came to believe the government and medical establishment were intentionally avoiding the question because they were afraid of the answer."
Why? Healy says some in the government make the mistake of treating vaccines as an all-or-nothing proposition. The argument goes something like this: everybody gets vaccinated at the same time with the same vaccines or nobody will get vaccinated and long-gone deadly diseases will re-emerge. (When I asked about cases of brain damage resulting in autism that have been quietly compensated by the government in vaccine court over the years, one government official recently told me that "it's still better overall to get vaccinated than not to get vaccinated.")
Healy says the argument need not be framed in those terms (vaccinate or don't vaccinate). Instead, she says, we should vaccinate, but work to do it in the safest manner possible based on what we know and what we can find out.
That's what the parents of autistic children have told me as well. If we can screen children to see which ones might be more susceptible to vaccine side effects, and vaccinate them on a more personalized schedule that is safer for them, why wouldn't we? If it's safer for all children to have their vaccinations spread out, why wouldn't we? Healy says it's called "personalized medicine" and is being done in virtually all areas of medicine today with the exception of vaccines. Yet the government continues to frame the conversation in all-or-nothing, "one-size-fits-all" terms.
Said Dr. Healy, "There is a completely expressed concern that they [mainstream scientists] don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. First of all, I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show."
Moving Goalposts, a Final Thought
Have we “moved the goalposts” by thinking more broadly about the total vaccine load our children are receiving? Yes, I think we have. Since the beginning, our focus has been guided by a singular logic: we want to know what happened to our kids. We want to know this for two reasons:
1. We can use this information to treat our children
2. We don’t want other kids to have the same fate as our kids if it can be prevented
I, for one, will keep moving the goalposts until I figure out, with certainty, what the hell happened to my beautiful baby boy.
Author’s Note: Portion of this essay were excerpted from the website PUT CHILDREN FIRST, which was written by the author. JB Handley is Editor at Large for Age of Autism.