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Monday, July 18, 2005

Danish study on autism-thimerosal flawed

By Evelyn Pringle
posted to Madison County Record

I enjoyed your article on the autism-thimerosal controversy. I got the feeling that you are a reporter who may be willing to look at the various theories regarding this issue.

Below is a short section of testimony by Republican Congressman David Weldon before a congressional committee regarding the validity of the government studies you cite in your article as dismissing a link between thimerosal and autism.

Because Weldon is also a physician, I hope you will take the time to review his opinion of the studies. He found a way to explain a very complex scientific matter in simple everyday words that even I could understand:

The IOM cited the 2003 Hviid study of the Danish population as one of the key studies upon which it based its conclusions. There exists a major conflict of interest of with its principal author. Dr. Hviid works for the Danish Epidemiology Science Center, which is housed at the Staten Serum Institute, the government-owned Danish vaccine manufacturer. Also, all of Hviid's coauthors either work with him at the center or are employed by the SSI.

The SSI, the Staten Serum Institute, makes a considerable profit off the sales of vaccine and vaccine components and the US is a major market for the SSI.

SSI has $120 million in annual revenue, and vaccines are the fastest-growing business segment, accounting for 80% of its profits. Both the US and the UK are important export markets for SSI's vaccines and vaccine components.

In addition, if Hviid were to find a link between Thimerosal and autism, SSI, with which he and his center are affiliated, would then face significant lawsuits. These facts are critical when evaluating Hviid's work. Furthermore, the Danish study looked at autism and not at neurodevelopmental disorders.

The important thing in evaluating this study is that exposure in the Danish population to Thimerosal varied considerably from that in the US. Danish children received 75 micrograms of mercury in their first 9 weeks and then another 50 micrograms at 10 months. By comparison, children in the US received 187.5 micrograms of mercury by the age of 6 months, nearly 2 1/2 times as much mercury as the Danish children.

Besides, Danish autism rates are six in 10,000, where in the US it is one in 167.

A case in point is the large-scale Danish study, published in Journal of the American Medical Society (JAMA) in September 2003, which found no link between thimerosal and autism.

The study is routinely cited as proof that the preservative is safe in vaccines. Soon after its publication, however, it was revealed that JAMA failed to disclose that the study’s authors work for Denmark’s largest maker and distributor of childhood vaccines-another company that could face lawsuits over thimerosal.

Another study that the IOM relied on was the Madsen study. Madsen et al., once again examined virtually the same population, Danish children, Danish children who received significantly less than they. Let us consider the conflicts of interest in the Madsen study.

First of all, two of Madsen's co-authors are employed by the same Staten Serum Institute. The study, like Hviid, added outpatient cases into the number of cases of autism after 1995, a methodological flaw. The authors acknowledged that this addition might have exaggerated the incidence of autism after the removal of autism. The IOM acknowledged this but yet used the data anyway.

Another study that the IOM cited, the Stehr-Green study, examined the Danish population again, along with the Swedish population. The problems with the Danish data need not be repeated, but with regard to Sweden, the children there received even less thimerosal than children in Denmark, receiving only 75 micrograms by 2 years of age versus children in the US receiving 187.5 micrograms by 6 months of age.

Furthermore, the authors included only inpatient autism diagnoses in the Swedish population.

The Miller study also included in the IOM report examines children in the UK. This study is still unpublished, which limits its ability to be examined critically. It is important to note, however, that Dr. Miller has actively campaigned against those who have raised questions about vaccine safety. We have a person here who is actively campaigning, testifying in lawsuits, against the theory that thimerosal is linked to neurodevelopmental disorders and autism, doing a study supposedly showing there is no link.

So what can we conclude about these five epidemiologic studies? Its easy to see why the IOM is on shaky ground in drawing the conclusion that it did. They based their decision on five studies, three of them examining genetically homogenous children in Denmark. At least one employee of the Staten Serum Institute serves as a co-author on three of them.

Only one study examines the US children, and it did not compare children who had received mercury with those who had not. Four of them are studies of children receiving less than half the amount of mercury that US children received. None of them with any ascertainment of prenatal or postnatal background mercury exposures, none of them considering prenatal exposure which may have been given to the children, three of them failing to address how the addition of outpatient cases of autism in Denmark might have previously skewed their results. Four examined populations with autism rates considerably less than the US, and one has never been published. It is impossible to review the data.

In addition to Congressman Welden's explanation, I think it is important to note that the extremely flawed IOM report denying a link between vaccines and autism has since been used (1) to endorse standardized case definitions for Adverse Events Following Immunizations for global dissemination; (2) as justification for Senate Bill 3's provisions and protections for drug companies; (3) as a cause for no further federal monies to be spent on research of the potential vaccine/autism link; (4) as a reason to silence media inquiries into vaccine safety issues; (5) and as a defense for dismissing over 4,500 petitions for vaccine injuries in a federal court.

I would also ask that you consider the following statement by one of the authors of the report:

Steven Goodman, MD, MHS, Ph.D, an associate professor and member of the IOM panel that issued their last report on thimerosal, said, "It was clear from the report that we were not giving thimerosal a clean bill of health. Mercury is definitely a neurotoxin. We didn't say that thimerosal is something that we should want in vaccines; we said that the safest vaccines are indeed thimerosal-free vaccines. We only said that the evidence favored that there was not a connection between autism and thimerosal exposure," according to the Naples Sun Times on April 27, 2005.

And finally, please consider the fact that after a judge in a case reviewed a leaked transcript of a meeting that showed the IOM had decided that it would deny the existence of a link between thimerosal and autism before they even examined the evidence because that was the expected outcome, he deemed it necessary to order drug makers to release mounds of discovery materials related to the ties between IOM committee members who authored the report:

A US District Court judge has ordered the worlds' “big five” vaccine manufacturers to “produce any and all documents relating to payments made to, or stock ownership” by the 17 members of the Institute of Medicine's Immunization and Safety Review Committee who issued a report last year denying a link between childhood vaccines and the country's autism epidemic.

The judge issued the order after receiving a leaked internal transcript in the first civil juried lawsuit against the vaccine manufacturers that allegedly proves the Institutes of Medicine's committee members “predetermined the necessity of not finding causality between vaccines and autism and/or neurological injury” in its official reports on the issue.

Judge T. John Ward also ordered the vaccine manufacturers to produce all communications with “members of the World Health Organization, the Center for Disease Control, the Food and Drug Administration, the Institute of Medicine, the Brighton Collaboration, or the Global Alliance for Vaccines and Immunization relating to the issue whether the thimerosal contained in pediatric vaccines causes autism or other neurological disorders.”

Vaccine makers Aventis Pasteur, Merck, GlaxoSmithKline, Wyeth and Eli Lilly are listed as defendants in the lawsuit brought by the parents of a child who developed autism after receiving mandatory vaccines.

Hopefully this information will give you a clearer perspective on this tragic issue.

I am an uninterested party in this controversy aside from my investigative interest in exposing the truth.

Evelyn Pringle
Dayton Ohio

Posted by Becca

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