Next June, when the Vaccine Trial of the Century gets underway in Federal Claims Court, government lawyers will defend the direct injection of toxic mercury into infant children by repeating the well-worn mantra that "five large population studies" in Europe and the US have completely exonerated the vaccine preservative thimerosal as a possible cause of autism.
But now it seems they may need to tuck a "Plan B" into their Federal briefcase.
Yesterday, UPI Senior Editor Dan Olmsted reported in his "Age of Autism" column that an NIH-led panel of experts has "identified several serious problems" plaguing the database used to produce the US vaccine study - the lynchpin of the "five large population studies" showing that organic mercury is just fine to shoot into kids.
The expert panel report, signed by NIH Director Dr. Elias A. Zerhouni, was sent to Congress in response to a query from Sen. Joseph Lieberman and seven colleagues last February. They wanted to know if the US database, the Vaccine Safety Datalink (VSD), could be used to compare autism rates in kids before, during, and after the gradual removal of thimerosal, which began in roughly 2000.
Unfortunately, the answer was a resounding "not really." A laundry list of "weaknesses" and "limitations" associated with the database would render such a comparative analysis "uninformative and potentially misleading," the panel said, (though it did suggest some excellent ways to re-approach the data going into the future).
Some weaknesses had to do with changes in medical practices over time. But many of the limitations sprang directly from the poorly designed VSD study itself (which, by the way, cost taxpayers many millions of dollars a year).
The panel was concerned about the way that autism diagnoses were made, and how accurately they were recorded by participating HMO's. It also questioned whether those HMO's offered adequate services for autism families, who might have sought alternative healthcare in more specialized settings.
These and other problems could easily have contributed to an "under-ascertainment" of autism cases within the VSD. As I report in my book "Evidence of Harm," most of the VSD kids lived in California, where autism rates at the time were about 30-40 per 10,000 children. But within the VSD itself, the reported rate was just 11.5 per 10,000.
The panel cited many other problems with the original VSD study design, particularly what it called "a large proportion, around 25%, of births excluded from the analysis."
Government researchers claim they excluded one-quarter of the kids to eliminate "statistical noise." But the panel argued that these same children "may represent a susceptible population whose removal from the analysis" might unintentionally reduce "the ability to detect an effect of thimerosal."
And there were still more "serious problems" to deal with. According to the panel, a proper study design should include prenatal factors such as maternal receipt of thimerosal-containing Rhogam (immune globulin) or "other vaccinations given during pregnancy," (including, by the way, the annual flu shot).
Finally, panel members worried that thimerosal alone did not paint the full picture of "the cumulative exposure of a child to organic mercurials through diet or other environmental sources." In other words, panelists said, we need to look at "total mercury burden" when assessing autism risks, and not just the shots.
All of these problems, as the panel put it mildly, "reduce the usefulness" of the VSD to prove or disprove a link between thimerosal and autism, (which happens to be precisely what the anti-mercury group SAFE MINDS told the government seven long years ago).
Which brings us to another problem. The VSD study is constantly held up by public health officials as EXHIBIT A in the defense of injecting mercury into little kids.
The study is perpetually cited by the CDC -- which conducted the study -- as the justification for keeping a neurotoxin in flu shots that the agency is currently imploring upon pregnant women and six-month-olds (who receive mercury on flu-shot days in quantities several times over the EPA limit).
The VSD is cited by the American Academy of Pediatrics as proof that mercury in vaccines is just fine for kids, even while warning us that mercury in the air, water and fish is not. It is cited by drug companies who stand to lose billions and billions of dollars in litigation if a link to thimerosal is ever determined. It is cited by incoming House Government Reform Chairman Henry A. Waxman, an avid vaccine supporter, who now has the power to investigate this potential medical and political scandal, but almost certainly will chose not to do so.
And, most importantly, the VSD study was the cornerstone of a 2004 report issued by the Institute of Medicine which not only ruled against a thimerosal-autism link, it took the extraordinary step of calling for a prompt end to all research into the matter. (And this despite an honest admonition from the VSD's lead investigator that his study was "neutral," and that it "found no evidence against an association.")
Which leads us to Vaccine Court. Armed with the new NIH panel report, lawyers for families seeking monetary relief can now effectively disarm the most powerful arrow in the government's mercury-defense quiver - even before the opening gavel.
This means that government lawyers will have to rely more heavily on the four remaining population studies, all conducted in Europe. Two were done in Denmark, where autism record keeping changed so radically during the study period that it "may have spuriously increased the apparent number of autism cases," after mercury was removed from Danish vaccines, according to the authors themselves.
In fact, Dr. Irva Hertz-Picciotto, the UC Davis public health professor who chaired the expert panel, told Olmsted that the US study was actually "an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs."
Then there is the fourth study, from Sweden, which only looked at autism cases that were diagnosed in hospital settings - a very low and wildly varying number each year. Of the five population studies, this is the probably the weakest and most easily dismissed, which is why you almost never hear about it.
That leaves the UK (a recent Canadian study not presented to the IOM failed to prove or disprove a direct link between childhood autism and thimerosal use in Canada, despite claims to the contrary).
There were actually two studies conducted in Britain (whose rates of thimerosal exposures and autism spectrum disorders roughly paralleled our own). Remarkably, both of them showed that children who got mercury in their shots were LESS likely to develop autism, leading the authors (some of whom had reported conflicts of interest with vaccine makers) to conclude that thimerosal had an apparent "neuro-protective" effect. That's right, according to the Brits, mercury is a wonder drug for kids.
That ought to impress the judge.
With so many holes shot through their "five large studies" defense, the government lawyers will be left to argue that autism is purely genetic, that there is no environmental component, and that the rates of illness have not "really" gone up. We are simply better at recognizing and diagnosing the disorder, that's all.
Well, if that is the case, the mercury-defense lawyers should have no problem proving it. All they need do is produce irrefutable evidence that 1-in-166 American adults of ALL ages (and 1-in-104 men) fall somewhere within the autism spectrum disorder, at the same rate as kids. But they can't, and they won't.
The government wants to defend its use of mercury in vaccines based on evidence drawn solely from epidemiological data ("population studies"), and highly questionable data at that. But its attorneys are trying to win their case in a Federal Court, and as Special Master Hastings, the presiding judge, must surely know, epidemiology is "not acceptable" to disprove causation, according to the Federal Court System.
Instead, one must also consider biological studies (animal, clinical, test tube) when assessing causation. And that's where the plaintiffs will come to court armed with reams of published evidence - produced at Harvard, Columbia, Davis, etc., and printed in prestigious journals - to suggest a highly plausible biological mechanism that would link a known neurotoxin with a neuro-developmental disorder, one that has become epidemic, (and expensive) in America.
Does the NIH report make it easier to claim that thimerosal harmed kids? Of course not. But it sure does make it harder to argue - let alone prove in a court of law - that it did not.