"A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a selective use of the data to make the associations in the earliest study disappear."-- Dave Weldon, physician and congressman
By Kelly Patricia O'Meara - Tuesday, December 9, 2003
Canned tuna or canned poison? That was the teaser for a CBS 2 News "HealthWatch" Report of Nov. 22 that focused on high levels of mercury found in tuna and the possible health risks associated with them.
CBS 2 News reporter Paul Moniz quoted a number of physicians, who observed of the toxic substance that, "Once it gets into our bodies, a substantial part of it will end up in our nervous system, in our brains, and it's there that it causes a variety of symptoms."
A pediatrician is quoted as saying, "We know that high levels of mercury can impair the cognitive development as well as the growth and development of a young child."
What the report appears to be revealing is that while overweight Americans may flee to fish to lose unwanted pounds, too much of that tasty tuna could reduce the IQ more than the waistline.
What the critics of mercury in vaccines find provocative about this report is the acknowledgement by physicians that the high levels of mercury ingested from canned tuna can cause severe health risks. One such critic, the mother of an autistic child, wonders "why everyone gets up in arms over ingesting small amounts of mercury from fish or from breaking a thermometer but finds it acceptable to inject an even more toxic form of mercury directly into the bloodstream of infants."
"The evidence is overwhelming," she contends, "that hundreds of thousands of children were damaged by gross overexposure to mercury through vaccines [containing thimerosal] and millions more were and continue to be put at risk, yet network news has not addressed this in any significant way. The public needs and deserves to know the truth – not only about the biggest medical bungling in our history, but also about the extraordinary efforts of both the pharmaceutical industry and government agencies to cover it up."
A pharmaceutical and government cover-up? It is a familiar enough accusation, and this time the fuse was lit by yet another study from the federal Centers for Disease Control and Prevention, or CDC, this one titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases. The report concluded that "no consistent significant associations were found between TCVs [thimerosal-containing vaccines] and neurodevelopment outcomes."
Critics scoff at such a conclusion.
"Sure," laughs one, "they say you can't eat tuna because the level of mercury you ingest isn't good for you, but there's no health risk associated with injecting high levels of mercury directly into a newborn baby?"
The CDC study, released in the November 2003 issue of Pediatrics, seemed to puzzle news media, with most who took note of it making at least a mention of the fact that the lead author, Thomas Verstraeten, was an employee of GlaxoSmithKline, the pharmaceutical giant and vaccine manufacturer, when he submitted the study for publication.
The first part of the two-phase study to determine whether there is a connection between thimerosal-containing vaccines and neurodevelopment disorders began in 1999 and involved the review of data from Seattle's Group Health Cooperative and Northern California Kaiser, both large health-maintenance organizations. The data used in this first phase actually revealed a significant association between TCVs administered to infants and later developmental abnormalities such as speech and language delays and neurodevelopment problems in general, such as tics and the alleged hyperactivity symptoms of attention-deficit disorder and attention-deficit/hyperactivity disorder.
However, this conclusion was not included in the final draft; it was only made public afterward when Verstraeten's notes were revealed in another forum, according to specialists. The notes, not published with the CDC study, showed that the "relative risk" for autism was 2.48 times higher for children who received 62.5 micrograms or more of mercury from TCVs by 3 months of age.
The second phase of the study in June 2000, however, involved the Harvard Pilgrim HMO in Massachusetts – an unlikely choice, critics say. Among the problems with using Harvard Pilgrim's database was that the HMO was in bankruptcy and had been taken over by the commonwealth of Massachusetts.
The medical records not only were incomplete, but the data were stored with a diagnostic coding system completely unlike that used in the first phase of the study using data from the two West Coast HMOs. Furthermore, the Harvard Pilgrim data, say the expert analysts, had incomplete data on autism and did not even address the issue.
Thus medical reviewers of the CDC study charge that it is rife with data manipulation. Since it relied on incompatible diagnostic coding to validate whether there were adverse effects from exposure to TCVs, the effect was to sabotage the result. So, they say, it was not surprising that the CDC study's analysis of the Harvard Pilgrim data found no consistent association between vaccines containing thimerosal and the mercury-related neurological disorders found previously in the first phase based on the two West Coast HMOs.
One of the few physicians in Congress, Rep. Dave Weldon, R-Fla., immediately saw the problems associated with the CDC study and notified CDC Director Julie Gerberding.
"I have serious reservations about the four-year evolution and conclusions of this study," Weldon wrote. "A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a selective use of the data to make the associations in the earliest study disappear."
Weldon's letter to Gerberding goes on to observe that "the first version of the study, produced in February 2000, found a significant association between exposure to thimerosal-containing vaccines and autism and neurological developmental delays. A June 2000 version of the study applied various data manipulations to reduce the autism association to 1.69, and the authors went outside the VSD [Vaccine Safety Datalink] database to secure data from a Massachusetts HMO [Harvard Pilgrim] in order to counter the association found between TCVs and speech delays." Clear enough.
The Florida lawmaker, who is a staunch supporter of immunization, tells Insight, "I don't know what's going on. It's a pretty lame study to begin with. The way they've done it is they got some findings and started adding more numbers to the denominator – it's kind of a strange protocol they followed. Then there are all these quotes from the researchers from other documents about how you can add numbers and stratify things and get any outcome you want. Then you consider that the lead author is working for a drug company, didn't disclose this fact and also that it is one of the drug companies being sued over this mercury issue. I'm just very concerned that we're not going to get answers as long as there are careers at stake. You know there are people at the CDC who have been involved in the vaccine program who didn't recognize the amount of mercury they were giving kids, and now they're in the process of investigating themselves. Meanwhile a lot of these investigators bounce to and from the drug companies. I think it all is very, very murky and very suspicious."
Weldon summarizes: "The CDC produced an article by Dr. Verstraeten, published on Nov. 3 in Pediatrics. Dr. Verstraeten is a former CDC employee. Since 2001 he has worked for GlaxoSmithKline – a vaccine manufacturer. While working for the CDC in 2000, the first version of Dr. Verstraeten's unpublished study found an association between higher thimerosal exposures and neurodevelopment disorders, including autism. Between 2000 and 2003, Dr. Verstraeten and coauthors manipulated and stratified the data so much that each of these associations magically disappeared. I don't know if it was deliberate, but that is nonetheless what happened. This study has done nothing in my mind to put these concerns to rest, but only serves to raise suspicions."
This veteran member of Congress puts it plainly: "We're not going to get answers to these questions until Congress or some outside group starts poring through this information. But it's very coincidental that they added the hepatitis vaccine, the HiB vaccine and the chicken-pox vaccine – they added all these additional childhood vaccines around the time when the autism rate started to skyrocket. Then when you actually sit down and do the calculations, according to the Environmental Protection Agency, they were giving these kids very toxic levels of mercury. I mean as a 150- to 200-pound adult the EPA says you're not supposed to take in more than one microgram per day. They were taking little seven- and 10-pound babies and pumping 50 and 75 micrograms of mercury into them in one shot. That's like giving an adult 1,000 micrograms. And, on top of that, the World Health Organization says mercury is 10 times more toxic in children than it is in adults. It's horrifying."
While Weldon and others cite huge and undeniable flaws, a spokesman for the CDC, Von Roebuck, tells Insight that "the CDC stands by the study." As he explains it, "We pretty much looked into that [manipulation of data] in the sense of how the information was presented, and we do stand behind it.
The CDC knew that Dr. Verstraeten worked for GlaxoSmithKline, and the one thing that we would want to happen differently is that would have been known before, but the work that Dr. Verstraeten did was for the CDC at the time the work was produced – the work that he did for the study was done when he worked for the CDC."
Mark Geier, M.D., Ph.D., is president of the Genetic Centers of America. He and his son, David Geier, president of Medcon Inc., are consultants on vaccine cases.
"What happened here is Dr. Verstraeten goes to the Institute of Medicine [IOM] and says that he looked at it in one California HMO and it was statistical and he saw the effect," David Geier tells Insight, "And then he did it in another California HMO and it was statistical and he saw the effect. Then he went to Harvard Pilgrim HMO and he didn't see the effect. The IOM said it's biologically plausible, but the epidemiology is mixed and therefore we're not sure."
"In my opinion," explains Mark Geier, "if they had seen clear epidemiology they would have recommended the immediate removal of thimerosal and hundreds of children would have been saved. But Verstraeten went to the one state in the country where the percentage of autism was the lowest. According to the U.S. Department of Education the average increase in autism was 400 percent, and every state in the union had at least a 100 percent increase. But Harvard Pilgrim had just a 10 percent increase."
"We went to Atlanta," he continues, "to the CDC, and looked at the VSD data. There is thimerosal-containing DTaP [diphtheria, tetanus and pertussis vaccine] and thimerosal-free DTaP, so we asked a question: Among children that got a minimum of either three consecutive thimerosal-containing DTaPs or three consecutive thimerosal-free DTaPs, was there a difference in the number of autism cases in the two groups? We found mega differences. More than 20 times higher. The rate of autism in the children that got more than three doses of thimerosal-containing DTaP vaccines was much, much higher. Almost all the children that have autism in that group were the ones that got the thimerosal-containing DTaP vaccine. The more thimerosal the greater the cases of autism."
Mark Geier says, "Believe us, there is no scientific issue here. This is fraud. The CDC and the FDA [Food and Drug Administration] know what is happening. They just can't admit it because it is one of the worst things ever to have happened to this United States. If a terrorist had done this, we wouldn't attack them, we'd nuke them. We're talking about one in eight children in the U.S. that currently are in special education, and that number is going to change to about one in five. What percentage of our young population can we destroy before we realize how serious this is?"
Lyn Redwood, a registered nurse, mother of an autistic child and president and cofounder of www.SafeMinds.org (Sensible Action for Ending Mercury-Induced Neurological Disorders), a nonprofit organization dedicated to ending devastation caused by the needless use of mercury in medicines, tells Insight that "there are so many problems with the study, but over time you can see how all the manipulations of the data slowly bring down the signals for neurological disorders. I think they were trying to get lower numbers. It must be very hard to admit that a program that was designed to eradicate infectious disease has resulted in an epidemic of a whole new kind of disease. But to think that we weren't given a choice when the regulators and manufacturers knew these products contained mercury is inconceivable."
Redwood says with a sigh, "On a scale of one to 10, I give the CDC study a big fat zero. I think it started out good, but when they saw the early numbers it scared the hell out of them. I don't have any faith in the CDC doing a decent study of this matter. It's like having the tobacco industry monitor cigarettes for safety. From a parent's perspective and from a health-care professional's perspective it's maddening that we can't get products that are safe, and yet we're forced by law to use them. They need to just get the thimerosal out. It's barbaric."
Kelly Patricia O'Meara is an investigative reporter for Insight.
© 2003 Insight/News World Communications Inc.