Expert warns vaccine studies are useless

For Immediate Release (June 5, 2003)

Dr. Thomas Jefferson, board member of the European Programme for Improved Vaccine Safety Surveillance and head of the vaccine division of the prestigious Cochrane Collaboration has announced that most safety studies on childhood vaccines are useless. "There is some good research, but it is overwhelmed by the bad," he stated. "The public has been let down because proper studies have not been done." Dr. Jefferson, who has been funded by the European Commission, said that vaccines were the "Cinderella" of public health research and that Government officials had not made it a high priority.

"In more than 200 years of vaccine use, there has been increasing evidence of the harm that vaccines have caused our children," says Meryl Dorey, President of the Australian Vaccination Network, a national health lobby group. "Dr. Jefferson's announcement is a wake-up call to everyone involved in this issue that before yet more vaccines are added to our already overloaded schedule, the proper ground-work needs to be done to prove that they are actually not doing more harm than good.." According to Dr. Jefferson, the information available on the safety of vaccines that are routinely given to babies and children was "simply inadequate".

Fifteen years ago, children received18 vaccines by age 5.Today, they receive 40. The vaccine train keeps rolling on despite the fact that these medical procedures have not been properly tested. There is an epidemic of auto-immune diseases which once were rare but now are common among Australian children. Conditions such as Asthma, Diabetes, and certain forms of Cancer have all been linked with vaccine use. Our children are our future and they deserve the safest possible vaccines. The government must show that they are committed to this goal by putting money towards independent vaccine safety research and by legislating to require that all health professionals report vaccine adverse reactions when they occur.

 

· Pichichero's work has been cited in 21 vaccine patent applications He was involved in the recommendation for the Wyeth rotavirus vaccine and failed to anticipate its risks. (4) This vaccine was withdrawn soon after licensure due to adverse reactions.   A substantial proportion of Dr. Pichichero's work involves vaccines. Safe Minds conducted a simple Medline search of publications listing M Pichichero as an author.(5) A breakdown of these publications by subject area shows that many focus on vaccines, especially those which contained thimerosal.

·         161 publications

·         23 DPT

·         7 Hib

·         1 HepB

·         1 Polio

·         3 Pneumococcal Conjugate

·         3 Rotavirus

·         4 New combination vaccines or general vaccine discussions

·         The remainder deal with otitis media and use of antibiotics

·         Note some articles were counted more than once because they addressed more than one vaccine

 Similarly, the University of Rochester web site provides biographical information on Dr. Pichichero, which describes his focus on vaccine research. (6) It describes him as an immunologist, not a toxicologist. None of his work involves safety assessment of a heavy metal or other toxicant. One paragraph cites his work on the Haemophilus influenzae type B vaccine, one of the thimerosal-containing vaccines that was added to the CDC/AAP-recommended infant schedule in 1991, nearly doubling the thimerosal load.

John Treanor, another author, has also conducted substantial research into thimerosal-containing vaccines, and the University of Rochester is one of a few sites designated by NIH for evaluating new vaccines. Investigators at the University of Rochester helped develop the Haemophilus influenzae B vaccine. Per its web site, "Rochester has become a national model...in ensuring that as many people as possible are immunized." (7)

STUDY DESIGN ISSUES

Sample

· The sample size was small. Although the overall sample size was stated as 61 infants, there were only 33 exposed children who were used for the blood mercury assessment upon which the safety conclusions were made.  One major shortcoming of a small sample size is the low chance of including infants who are especially sensitive to mercury's effects, or who may have detoxification difficulties. We know from the mercury literature that there is wide variability in the population in regard to mercury sensitivity and clearance. Since vaccines are given to virtually all infants, even if 1% retained mercury to a much greater degree than the "norm", this would represent a large number of injured children.

·         In the Pichichero study, there is one infant blood level out of the 17 2-month old blood samples (12%) which was 20.55 nMol/L, or 4.1 ppb. This infant had its blood drawn at day 5, received 37.5 mcg/Hg, and weighed 5.3 kg.

·         a) Day 5 is past the peak value in blood, meaning that at days 1-3, levels would be much      higher.

·         b) A 37.5 mcg dose is (conservatively) 60% of what a typical 1990s infant may have received (37.5/62.5=60%).

·         c) A 5.3 kg infant is at the 95th percentile of weight for a 2 month old, that is, a large, heavy baby. Since blood Hg concentrations are in part dependent on weight, a child with a lower weight than this infant (that is, 95% of the 2 month old population) would have had a higher blood level than this infant.

·         The implications of points a, b, and c are that (1) if the study infant's blood were taken at 1-3 days, it is more than likely that the Hg levels would have exceeded 6 ppb; (2) it is likely that the peak levels of more than 12% of 2 month old children children given the full 62.5 mcg of mercury would exceed 6 ppb; and (3) a larger percentage of smaller infants - but still those of "normal" weight - would be likely to have blood levels exceeding 6 ppb.

·         In addition, there were two other 2 year olds with mercury levels at between 10 and 15 nMol/L. These values are with 1/2-1/3 of the EPA margin of safety, with blood draws on days 6-7.

·         For these reasons alone, the results of the Pichichero study are anything but "reassuring" to parents whose children were exposed to thimerosal as infants.

LEARNING FROM THE STUDY

·         Despite its many limitations, the Pichichero study does provide new or confirming information about the pharmacokinetics of ethylmercury injected into infants.

· The half life of ethymercury in infants appears to be shorter than methytlmercury, approximately 6-7 days. Pharmacologically, this period would be considered a very long half life and a long time for a toxic substance to be circulating in the body. In fact, the single blood draw after 20 days for which mercury quantitation could be made showed mercury being circulated at about 5 nMol/L. In a developing brain a few days are significant time periods for an agent that interferes with cell division and organization.

· The control group had no detectable mercury, indicating that the mercury in the exposed group was due to the thimerosal in the vaccines

SUMMARY

·         The Pichichero is a small-scale descriptive study with many design limitations, which has moderate value in advancing understanding of ethylmercury pharmacokinetics. It has little if no value as a safety assessment of thimerosal from vaccines, and its conclusions are overreaching, perhaps reflecting a bias on the part of its lead author towards absolving lisenced vaccines of any adverse effects.

References

·         (1) Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study, by Michael E Pichichero, Elsa Cernichiari, Joseph Lopreiato, John Treanor. The Lancet. November 30, 2002.

·         (2) UpToDate.com web site. Accessed 11/29/02. http//www.utdol.com/application/help/conflict.asp

·         (3) Acute Otitis Media Part I. Improving Diagnostic Accuracy, by Michael E. Pichichero, M.D. American Academy of Family Physicians newsletter, April 2000. Site accessed 11-29-02. http://www.aafp.org/afp/20000401/2051.html

·         (4) Rotavirus vaccines and vaccination in Latin America, by A. C. Linhares and J. S. Bresee. Pan Am J Public Health. 8(5) 2000. Accessed 11-30-02. http://www.paho.org/english/dbi/es/ARTI--Linares.pdf

·         (5) Pichichero Publications based on Medline Search of November 30, 2002, by Safe Minds

·         (6) Biographical Information on M. Pichichero, University of Rochester web site. Accessed 11-29-02. http://www.urmc.rochester.edu/gebs/faculty/Michael_Pichichero.htm

·         (7) Vaccine Technology Takes Center Stage in Rochester, University of Rochester press release, October 8, 1998. Accessed 11-30-02. http://www.rochester.edu/pr/releases/med/vaccines.htm

·         (8) Development of Methylmercury Reference Dose, by Dr. Kathryn Mahaffey, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Site accessed November 30, 2002. http://www.masgc.org/mercury/

http://www.medscape.com/viewarticle/445538

Medscape Medical News
Mercury in Vaccines: A Newsmaker Interview With Michael E. Pichichero, MD

Laurie Barclay, MD


Dec. 3, 2002  Editor's Note: There has been much debate about the safety of thimerosal, which is used as a preservative in childhood vaccines and also in adult influenza vaccines. Although studies generally have shown that mercury levels after vaccination are not a problem, the American Academy of Pediatrics (AAP) successfully lobbied to have thimerosal removed from all childhood vaccines. The first detailed analysis of blood, stool, and urine mercury levels in 61 infants who received vaccines containing thimerosal, published in the Nov. 30 issue of The Lancet, indicates that blood levels of mercury in children are well below current safety limits established by the Environmental Protection Agency (EPA). Surprisingly, the elimination of mercury in these children was much faster than predicted from studies of mercury toxicity from seafood. Based in part on these findings, the World Health Organization (WHO) put forth guidelines saying that thimerosal is safe and should continue to be used.

To clarify these findings and their implications, Medscape's Laurie Barclay interviews lead author and lead investigator of The Lancet article, Michael E. Pichichero, MD, a professor of microbiology, immunology, pediatrics, and medicine at the University of Rochester Medical Center in New York.

Medscape: Please summarize your Lancet study results and their implications for the safety of vaccines containing thimerosal.

Dr. Pichichero: We looked at the [blood] level of mercury in children who received thimerosal-containing vaccines. Not a single child had a blood mercury level approaching the lower safety limit established by the EPA. Former predictions of possible pediatric problems with mercury in vaccines, which led to removal of thimerosal from U.S. vaccines, were based on the notion that metabolism of ethyl mercury in the vaccine was the same as that of methyl mercury in fish. But our study showed that elimination of ethyl mercury from the vaccine was about six times as fast as that of methyl mercury. The rapid metabolism probably accounts for the very low blood levels in the children we studied.

Medscape: Could blood levels of mercury be misleading in that blood levels could be low even while mercury is accumulating in bone or in organs?

Dr. Pichichero: We accounted for virtually all the mercury contained in the vaccine in the stool of these children, with not much excretion in the urine. So there really is no evidence that there is any mercury unaccounted for which could be accumulating in bone or elsewhere, although this study was not a toxicity study and did not examine this issue directly.

Medscape: Although these results appear to be reassuring, are there any study limitations to consider in interpreting the findings? 

Dr. Pichichero: This was a small study of 61 children: 20 two-month-olds who got thimerosal, 20 six-month-olds who got thimerosal, and 21 controls. Because we didn't anticipate the rapid clearance of ethyl mercury with half-life of only six to seven days, we predicted the sampling times on the basis of an assumed 45-day half-life.

Medscape: On what basis did the EPA set public safety limits for mercury levels?

Dr. Pichichero: The EPA levels were largely based on studies from the Faroe Islands which looked at the toxicity of methyl mercury ingestion from whale blubber. Mild neurodevelopmental problems occurred at blood levels of 200 to 300 ng/mL, and the mildest detectable neurodevelopmental toxicity occurred at blood levels of 58 ng/mL. So the EPA decided they'd add in a safety factor of 10, and they reasoned that levels should not exceed 5.8 ng/mL to be totally safe. In our study, most children had levels of 1 to 2 ng/mL; two had levels of 2-3 ng/mL, and one had a level of 4 ng/mL. No child approached the EPA safety limit.

Medscape: Do you think that the Faroe Islands studies form an adequate basis on which the EPA can determine safe blood levels as they pertain to infants who receive vaccines containing thimerosal?

Dr. Pichichero: Actually, it's not an adequate basis because the situations are not strictly comparable. First of all, the Faroe Islands study looked at levels of mercury in fetal cord blood when mothers ingested mercury from whale blubber. If anything, the fetus has been shown in human studies to be more susceptible to the toxic effects of mercury than are infants, because mercury easily penetrates into the fetal brain and kidneys and causes damage.

The other issue is that the Faroe Islands study looked at methyl mercury exposure, but thimerosal contains ethyl mercury. The FDA [Food and Drug Administration] assumed that metabolism of these two organic forms of mercury was closely correlated, but this was not validated by our study. We now know that the two forms are metabolized and eliminated differently. But our data are very reassuring in that the metabolism of ethyl mercury appears to be six times faster than that of methyl mercury.

An editorial accompanying the Lancet paper suggests that another study will soon be published comparing the effects of ethyl and methyl mercury. But from a toxicity point of view, once mercury is freed from its organic bonds, mercury is mercury, and it's the free form that enters the brain and kidneys and can cause damage. Our study did not examine toxicity, but we measured blood levels of free mercury, not of ethyl mercury.

Medscape: Why did the AAP urge vaccine manufacturers to remove thimerosal from U.S. vaccines? Do you think that this recommendation should be changed or updated?

Dr. Pichichero: It's very reassuring for America's children that the hypothetical concerns which led to thimerosal removal were not validated by our study. The AAP and the FDA are not likely to reverse their decision based on our findings, now that thimerosal has been replaced with other preservatives. Although this drove up the cost of vaccines, we as a wealthy nation have absorbed this cost. But the FDA and the AAP should be very pleased with our findings, which speak to the millions of children who have already received vaccines containing thimerosal. Our findings were also pivotal in the WHO's recommendation that thimerosal will remain in all vaccines provided by them to other countries.

Medscape: What are the advantages of using thimerosal in vaccines?

Dr. Pichichero: Cost is a major issue. If you don't use preservatives at all, you have to dispense vaccine in single-dose vials, which is not only more expensive but which may lead to more errors in administration. In underdeveloped countries where millions of children die of whooping cough, tetanus and measles, switching to a thimerosal-free vaccine would raise the price so high that millions of children would not be vaccinated.

The potential toxicity of using newer preservatives, as we now do in the U.S., is unknown, so we're trading the very small, known risk of thimerosal for an unknown one. The new preservatives in U.S. vaccines are presumed to be safe, but I'm not an expert on vaccine preservatives, and I don't know the extent of background research supporting this presumption. 

Medscape: Is any additional research planned to clarify safety issues for
thimerosal?

Dr. Pichichero: We are collaborating with a laboratory in Seattle to look at nonhuman primate models to study possible mercury accumulation and other potential toxicity of thimerosal in vaccines. We're also doing a large follow-up in Buenos Aires, Argentina, in which we'll more carefully examine and quantitate these findings in larger numbers of children. 

Medscape: Please comment on the provision in the Homeland Security Bill that protects pharmaceutical manufacturers from lawsuits related to adverse effects of childhood vaccines.

Dr. Pichichero: The three major manufacturers of thimerosal-containing vaccines are GlaxoSmithKline, Aventis-Pasteur, and Wyeth. The Childhood Vaccine Protection Act is a long-standing piece of legislation which protects the pharmaceutical manufacturers against lawsuits involving vaccines recommended by the government. This legislation came into effect about a decade ago because all the lawsuits led to vaccine shortages. I'm not aware of any specific provisions in the Homeland Security Act dealing with this issue, but I haven't studied it specifically.

Lancet. 2002;360:1711-1712, 1737-1741

Reviewed by Gary D. Vogin, MD

 

Vaccine Science Review #2

Official site: http://www.freedom2think.com/vaccinescience

by Helen Tucker

Article reviewed:
Pichichero, M. et. al. 2002. "Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study." The Lancet 360: 1737 - 1741.

[A free copy can be obtained from http://www.thelancet.com/ .]

Review abstract:

Pichichero et. al. studied samples taken from infants given thimerosal* vaccines and infants given thimerosal-free vaccines. Mercury was found more frequently and in higher levels, in the blood, urine, and stool of thimerosal exposed children. The authors concluded that "Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants," but referenced a mouse study for these "safe values." They also estimated that the half-life of ethylmercury was around 7 days and "eliminated from the blood rapidly via the stools," even though they took samples only once per subject.

*(also spelled thiomersal, mostly in UK and commonwealth countries)

A. What did the authors do?

The authors took samples from:

a) 40 infants who had received vaccines containing thimerosal,

b) 21 infants who had received thimerosal-free vaccines,

c) their mothers, and

d) 9 additional infants who had not received any vaccines containing thimerosal who provided stool samples.

The vaccines included DPT, Hepatitis B, and Hib in both the exposure group and the control group, but an unspecified number of infants did not receive the Hib. It is therefore unknown exactly how much mercury each infant was exposed to from vaccines.

The samples were taken between 3-28 days after vaccination, taken on different days for different subjects. Samples included blood, urine, stool, maternal hair, and maternal breastmilk, but were not taken consistently from all subjects. Cold vapor atomic absorption was used to measure mercury levels in these samples.

Seven thimerosal-exposed and six control blood samples were excluded because insufficient blood was drawn. Only 33 thimerosal-explosed and 15 control blood samples were measured for mercury. Out of this number, only 21 thimerosal-exposed and 1 control blood sample were defined to be within the "range of reliable quantitation." Only the data from these 22 blood samples were included in calculations.

Urine samples were taken from 27 thimerosal-exposed children and 14 of the control children. Stool samples were taken from 22 thimerosal-exposed children. No stool samples were taken from the control group. Rather, they took stool samples from a second control group of 9 aged-matched children who had not received thimerosal-containing vaccines, who were not mentioned in the abstract and whose data was not included in the table of results.

Maternal hair samples were taken from all mothers of the 61 thimerosal-exposed and control infants. Breastmilk samples were taken from 8 mothers (no information given on whose mothers).

A simplistic mathematical model was used to estimate the half-life of ethylmercury based on the distribution of blood mercury levels in 21 blood samples taken on different days from 21 different children.

B. What did the authors find?

1. Out of the 21 blood samples from thimerosal-exposed children, the average mercury concentration was 8.20 nmol/L (SD=4.85) for two month olds, and 5.15 nmol/L (SD=1.20) for six month olds. (It is unknown if this difference is statistically significant.)

2. The only data for the control group came from one blood sample from a two month old child. It showed 4.90 nmol/L.

3. Mercury was detected in urine samples in only 4 out of 27 thimerosal-exposed children, and none of 14 control children. (It is unknown if this difference is statistically significant.)

4. For the 4 urine samples with detectable mercury from the exposure group, the values were 3.8 nmol/L for a two month old, and 5.75 nmol/L (SD=1.05) for 3 six month olds. (It is unknown if this difference is statistically significant.)

5. Out of the 22 stool samples from thimerosal-exposed children, the average mercury concentration was 81.8 ng/g dry weight (SD=40.3) for two month olds, and 58.3 ng/g dry weight (SD=21.2) for six month olds. (It is unknown if this difference is statistically significant.)

6. The average mercury concentration in stool samples taken from the 9 children in the second control group was 22 ng/g (SD=16). These 9 children had significantly lower levels of mercury in their stool (p=0.002) than the exposure group.

7. Maternal hair values were 0.45 :g/g for the exposure group and 0.32 :g/g for the control group. Mercury concentrations in maternal hair were not significantly different between the exposure group and the control group.

8. Breastmilk from 8 unidentified mothers averaged 0.30 :g/g (range 0.24-0.42 :g/g) of mercury.

C. What were the flaws of the study?

1. Unknown mercury exposure. Without knowing how much mercury exposure the subjects had, and how much of this total exposure came from vaccines, no conclusion can be drawn on the effects of vaccines on mercury levels found.

a. No samples were taken from the subjects before vaccination. This would have been the easiest way to control for other sources of mercury exposure. Without taking a comparison sample, how could the authors have known if blood concentrations of mercury were "raised" after vaccination, let alone determine how much they were raised and that any amount raised was safe?

Omitting a pre-vaccination sample from the design effectively rendered any connection with the subject of vaccines indefensible. Any conclusion that mentioned vaccines, such as "thiomersal in routine vaccines poses very little risk to full-term infants," is completely unsupported by the information available in this study.

b. The authors did not say how many children did not receive all three vaccines. We do not even know exactly how much mercury was injected into each child.

c. It is unknown how much mercury the children were exposed to from other sources such as diet (e.g. tuna fish) and air pollution.

The authors tried to address this problem by studying mercury levels in a control group. However, the only control data came from ONE blood sample in the entire study and 9 stool samples from children who were not formally part of the study. This does not provide adequate comparison to determine how much mercury exposure existed outside of vaccines.

The authors also tried taking maternal hair and breastmilk samples. Those samples showed that, indeed, the mothers have been exposed to mercury. But it is unknown if maternal mercury levels came from mercury exposure that is shared by their children (e.g. if their exposure came from their vaccines or drugs or came from past residence in a polluted area). Even if one assumes that the mothers' mercury exposure is shared by their children, we still do not know how much. For example, maternal hair mercury does not translate into a specific amount of mercury concentration in the blood of their children.

2. Invalid sampling within the study population. There is an overwhelming number of questionable exclusions in an already small sample size.

The authors claimed to have studied 61 children. The small initial sample size of this study means any conclusion, even if all 61 children were used to provide data, would have to be interpreted with extreme caution.

In reality, they studied data from only 21 blood samples, 31 stool samples, and 27 urine samples from separate children. There is no information on how many of these samples were from the same children. There is no information on why stool and urine samples were not taken from all subjects. No one knows if these samples were excluded objectively or because they would have provided data the authors did not like. Without objective evidence to explain why some children were excluded from providing stool and urine samples, none of the stool and urine concentration results have any scientific meaning.

Although they did try to take blood samples from all 61 children, they excluded almost 2/3rds of those blood samples for two dubious and poorly defined reasons. The first reason was insufficient blood volume, which can only be interpreted as stupefying incompetence. If insufficient blood was drawn because the infant was not able to participate properly, the subject should have been dismissed from the study.

The second was mercury levels falling outside the "range of reliable quantitation." The authors did not explain this criterion, except to say that that mercury levels found below the range of 2.5 to 7.5 nmol/L, depending on blood volume, were excluded. However, they showed a data plot (Figure 1) where 17 out of 21 other samples with levels within that range were included. The only factor that could have excluded these samples would again be blood volume, which was not defined. No one knows if these samples were excluded objectively or because they provided data the authors did not like. The authors fail to present sufficient objective evidence to explain how these exclusions were not subjective and arbitrary. Without such evidence, none of the blood concentration results have any scientific meaning.

3. Ridiculous calculations of half-life:
The authors admitted that this was not a formal pharmokinetic study, where the same subject would be tested repeatedly for mercury at regular intervals after exposure. However, they felt that taking single samples from 21 children at "various time points after exposure" could suggest a "half-life of less than 10 days." In other words, they could estimate the half-life by pretending all 21 samples were from the same person. Given the extremely small sample size used, this assumption is nothing but ridiculous.

The mathematical model they used for calculation half-life was simple, but it did require at least two samples from the same subject to be able to calculate any change in that subject. Without using at least two values from the same person, this model is meaningless. Taking two samples from two different children and pretending their difference is a change in mercury level in the same child is ludicrous.
(Under Unconscionable Conclusions)

4.  "Assessment of these samples suggested that the blood half-life of ethylmercury in infants might differ from the 40-50 day half-life of methylmercury (range 20-70 days) in adults and breastfeeding infants.  The concentrations of blood mercury 2-3 weeks after vaccination noted in our study were not consistent with such a long half-life, but suggested of a half-life of less than 10 days."

Half-life is a function of change within the same subject.  It is not the difference between Child #1 on Day 1 and Child #2 on Day 2.   Any calculation of half-life based on the difference in concentrations taken from 2 different children is fraudulent. 

4. Unconscionable conclusions by the authors.


1. "Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants."


They have no scientific data in this study to support any statement about the effects of vaccines on increased blood levels. As explained above, since only one sample per child was taken, there is no basis to determine that there was even an increase, let alone attribute an "increase" to vaccines. They also had no basis to make any statement about blood concentrations of mercury, given that samples could have been excluded subjectively. No reference or any other justification is provided for the authors' definition of "safe values in infants." This problem is explained below.

2. "However, no children had a concentration of blood mercury exceeding 29 nmol/L (parts per billion), which is the concentration thought to be safe in cord blood; (18) this value was set at ten times below the lower 95% CI limit of the minimal cord blood concentration associated with an increase in the prevalence of abnormal scores on cognitive function tests in children. " [no reference provided.]

It is incredible, but the reference (footnoted #18) provided for 29 nmol/L as" the concentration thought to be safe in cord blood," is titled:

18. Nielsen JB, Andersen O, Grandjean P. Evaluation of mercury in hair, blood, and muscle as biomarkers for methylmercury exposure in male and female mice. Arch Toxicol 1994; 68: 317-21.

I have read Nielsen's mouse paper in full, and have found no data or information that be construed as defining safe levels of mercury in human cord blood. The second half of the sentence did not even have a reference. Without references, the reader cannot know what these "safe values" are and where they came from, let alone determine if those values are valid. It is mind-boggling that the authors would fail to present ANY evidence whatsoever to justify the safe levels of mercury used for comparison.

I have written Dr. Pichichero, the principal author, on February 20, 2003 asking for correct references, and will update this review if correct references are given. (Although no reference was given for the second statement, I did find one of the references to be on the correlations between cord blood mercury concentrations and cognitive deficits. After reading it, I have not found any data to support the number cited in this paper either.)

3. "Ethylmercury seems to be eliminated from blood rapidly via the stools after parenteral administration of thiomersal in vaccines."


Elimination means a decrease in mercury levels obtained at two different times from the same child. Since only one sample was taken per child, there is no basis for determining there was a decrease in anything. Again, this conclusion required pretending 21 children were really the same child over the period of 28 days and the small sample size does not allow this pretense. Because they did not take a pre-vaccination sample and no immediate post-vaccination sample, there was absolutely no evidence in this study to conclude that mercury concentrations in blood came from thimerosal in vaccines. For all the evidence presented in this study, vaccine mercury could have traveled in the blood in the first 3 days to be stored in brain tissue, to never be eliminated or to be eliminated very slowly over years, and the mercury found in stools came from previous dietary mercury exposure. This study has no data to prove or disprove this hypothesis anymore than it has data to prove the conclusion that vaccine mercury is eliminated quickly.

D. What can be concluded from this study?

1. Mothers of infants in this study were exposed to mercury, source unknown. There was no significant difference between the hair mercury levels in mothers of subjects in the exposure and the control group.

2. Mercury is more prevalent in the stool samples than in the urine samples of some infants in this study, although this prevalence could have been an artifact of subjective exclusion.

3. Stool concentrations of mercury, source unknown, were significantly higher in exposure subjects than in 9 subjects used as controls, but who were not formally part of the study.

Because the paper fails to provide objective evidence meeting minimal scientific standards (or even normal common sense), no other conclusion is justified. In fact, this paper dangerously borders intellectual fraud from imagining relationships between data where none exist.
------------------------------------

The author would like to thank the Vaccine Science discussion list for their input and feedback.

http://groups.yahoo.com/group/VaccineScience/

Permission is granted to forward or reprint this article on the condition that it is reproduced in its entirety without any changes (everything between and including the 2 asterisk lines). If this article is reprinted on another website, the author would appreciate a note with the link to the site. Her email address is list@freedom2think.com.

You know, I found the data on how much mercury each study subject received from vaccines. I was mistaken. They did include that information, but only in the abstract, which I had apparently overlooked. (Who puts data in the abstract, but not in the body of the paper?)

Anyway, the mean mercury doses that these kids received were 45.6 :g for 2 month olds, and 111.3 :g for 6 month olds. 111.3 :g! That is actually 111,300 ng of mercury. When they tested blood samples, they found a mean of 5.15 nmol/L for 6 month olds. Now, follow along with me here.

1 mole of mercury = 200.8 grams.
1 nmol = 200.8 ng
5.15 nmol x 200.8 ng/nmol = 1034.12 ng
The average blood concentration was 1034.12 ng/L.

Blood volume is about 8% of infant's bodyweight.
6 month old boy average weight is 8 kg = .64 kg blood = .64 L blood.
1034.12 ng/L x .64 L blood = 654.08 ng of mercury in the blood of the 6 month old baby

What I want to know is, where did the rest of the 111,300 ng of mercury go, if it isn't in the blood?

To say that it was eliminated in the stools, they really needed to take entire stool samples before vaccination, and every day after vaccination for about 30 days. That way they know how many total grams of stool is passed per day and what concentration mercury there is in the stool every day. Then they can calculate how many total ng of mercury actually came out of the baby in 30 days. Short of this, they can't tell me that the mercury isn't still in the baby. I mean, we know for a fact the mercury went in. We don't know for a fact that all of it came out.

Vaccine Science Review #1

Official site:  http://www.freedom2think.com/vaccinescience

by Helen Tucker

Article reviewed:
Barlow, W. et. al.  2001.  "The Risk of Seizures after Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella Vaccine," New England Journal of Medicine 345: 656-661

[A free copy can be obtained from http://www.nejm.org/ .]

Review abstract:

Barlow et. al. studied data from four HMO's on the west coast to assess the risk of seizures and neurobehavioral disorders after receiving the DTP and MMR vaccines.  They reviewed 624 medical records out of an undisclosed number of children using undisclosed methods and misleading control groups to calculate meaningless risk coefficients.  They then concluded there were only small, "transient" seizure risks associated with DTP and MMR which "do not appear to be associated with any long-term, adverse consequences."

A.  What did the study do?

The authors said they studied nearly 680,000 children aged 0 - 7 who were enrolled at these HMO's during the observation period, which was different at each HMO, but ranged between 1/91 to 9/93, with some follow-up data extending to 1998.

The authors concluded that there was a slightly increased risk of febrile seizures on the day of vaccination with DTP, which is estimated to mean 6 to 9 additional febrile seizures for 100,000 children.  They also found a slightly increased risk of febrile seizures in the second week after the MMR, which is estimated to mean 25 to 34 additional febrile seizures for 100,000 children.  They concluded there was no increased risk of  nonfebrile seizures, subsequent seizures after the first febrile seizure, and neurobehavioral disorders for children receiving the DTP and MMR.

B.  What were the flaws of the study?

1.  Meaningless sample:  The authors failed to provide sufficient evidence that their sample was valid and representative of the population they were studying. 

Although the study started out with almost 680,000, the authors excluded an unknown number of children, without a clear explanation.  The sample size was narrowed by at least 42,000 at the beginning to about 638,000 "person-years of observation," (i.e. persons per year of observation) which means the number of unique children could be even smaller.  It was also narrowed by 13.7%--of which number, they never said--because of disenrollment from the HMO's. 

From whatever figure they ended up with, they found 2281 possible seizures from highly variable sources depending on the HMO, anywhere from hospitalization records to neurology referrals.  They never explained how many seizures came from each source.    From the 2281, they sampled 1094 for risk analysis.  Because sampling proportions varied from HMO to HMO, the authors weighted the data from some random samples to make them comparable to the rest.  They did not say how many seizures came from each HMO and how many cases were weighted.  The authors admitted the sample was somewhat biased toward severe, hospitalized cases, but failed to present information necessary to objectively assess the extent of the bias. 

From the 1094, they whittled the final sample down to 624 children on which they presented results of their analysis.  They excluded children because seizures happened outside of the study period or before the inception of a vaccination database, but never defined those dates.  They excluded children because of specific infections or injuries, but never defined them.   They presented a category of neonatal seizures, but never discussed them in the analysis, so it was even unclear who exactly were excluded.  Without the objective criteria by which subjects were excluded, there is insufficient evidence to determine that the sample was not further biased.  It was the authors' responsibility to justify their sample as valid and representative, and they failed.

2.  Meaningless and Misleading Control Group:  The authors compared children who were recently vaccinated to children who were not recently vaccinated to conclude that the risk of vaccines over the "absence of vaccination" was small.

To assess the risk of seizures among children who had received the DTP and MMR, the authors needed to compare children "exposed" to DTP and MMR to children who were "unexposed."  The exposed group was defined as children who had had either the DTP, the MMR, or both vaccines concomittantly in 30 days preceding the first seizure episode.  The unexposed group was defined as children who had not had either vaccine in the last 30 days.   The authors implied, but never explicitly stated, that the "unexposed" group was also unexposed to any other vaccine in the last 30 days before seizure.  The control situation was referred to as "absence of vaccination."

The authors did not provide evidence that a 30 day difference between the exposure to vaccines in the two groups is sufficient time to meaningfully distinguish between presence of vaccination and "absence of vaccination," exposure and "nonexposure."  The authors needed to carefully qualify that their risk calculations were only for children who were recently vaccinated with DTP/MMR compared to children who were not recently vaccinated.  They needed to qualify that they were in all likelihood comparing vaccinated children to vaccinated children.  They did neither.

The authors also wanted to assess the seizure risks of DTP and MMR separately.   The fact that some children received both DTP and MMR in the last 30 days before their seizures confounds the risks attributed to either vaccine individually.  The extent to which the variables were confounded is unknown because the authors did not say how many received both vaccines. 

Finally, the authors admitted that vaccination status was not always accurate.  They did not explain how many were inaccurately identified as vaccinated or unvaccinated, and how they resolved disagreements.

3.  Meaningless and Unreliable Risk Calculations:  The authors failed to present data and justification for their calculations and used invalid background rates as the foundation of all their conclusions.

The authors concluded that certain risks were small and other risks were non-existent.  The only evidence provided to support these conclusions were calculations of "relative risk."  The authors said they used the "stratified Cox proportional-hazards analysis" and "standard methods" to calculate these numbers, but did not define what these methods were, provide equations, provide literature references, or present any other information that would validate these calculations.  They curiously did not present results such as how many did not get seizures vs. the numbers who did.  Without these numbers, the accuracy of their calculations cannot be gauged. Furthermore, these relative risks were calculated after "adjustments" for selected variables.  Although they defined some of these variables, others were unclear and how the calculations were "adjusted" was not explained.  Because there is insufficient proof that these statistical methods were applicable to the data collected, their results of those methods are meaningless.  Because there is no presentation of most of the data used in these calculations, their results are meaningless.

The only numbers presented was each "relative risk" and its 95% confidence interval, such as "5.70 (95% CI, 1.98 to 16.42)."  The confidence intervals they did provide showed that these calculations were highly unreliable.  For example, the risk of "5.70 (95% CI, 1.98 to 16.42)" translates to mean that 95 times out of a 100, their calculation could range anywhere from 2 to 16. 

In addition, these relative risks were compared to two "background rates" of febrile seizures to determine how many additional seizures per 100,000 children can be attributed to DTP or MMR.  One of the background rates came from the same data as the risk calculations, so it is not surprising that there was only minimal difference between the two.  The other background rate came from a 1969 published study of one of the participating HMO's, with data more than 20 years old.  The absence of more current and broader background rates makes the number of additional seizures attributed to DTP/MMR meaningless.

4.  Meaningless Follow Up.  The authors followed whichever children they wanted, for only the diagnoses they wanted, then calculated meaningless numbers after "adjusting" the data, to yield the conclusion that the vaccines were not associated with "long-term, adverse consequences."

Out of the 74 children who had febrile seizures within 30 days of vaccination, the authors followed only 40 to study any increased risk for subsequent seizures.  For the DTP, they followed only children who had febrile seizures in the first 7 days.  For the MMR, they followed only children who had febrile seizures within 7 - 21 days.  They did not explain why they followed only these children and not all of them.  They did not follow any children with nonfebrile seizures after vaccination because the authors believed there was no association between the two events.  The control group consisted of 521 children who had febrile seizures in the "absence of vaccination," that is, no DTP/MMR in the preceding 30 days.   The authors did not explain how long these children were followed, though they suggested that some of the children were followed for at least 2 years.  Nonetheless, they concluded the 40 exposed children were no more likely to have subsequent seizures than the 521 "nonexposed" children. 

Out of the 561 children followed for subsequent seizures, 273 were followed for neurobehavioral diagnoses.  Again, the authors do not explain how the 273 were followed, for how long they were followed, and why they excluded the rest.  The diagnoses they flagged included:

"ADD, learning disorders, mental retardation, speech disturbances, emotional disturbance, personality disorder, repetitive-movement disorder, obsessive-compulsive disorder, infantile autism, childhood type schizophrenia, and psychoses of early childhood."

Notably, with the exception of infantile autism, they did not include any of the Pervasive Developmental Disorders considered to be in the autism spectrum. 

The authors concluded that the risk of these conditions did not differ between exposed and unexposed children, after an "adjustment" for age at the time of the seizure.  This implies that there was a difference between exposed and unexposed without the adjustment. The only evidence cited to support this conclusion was again, one "relative risk" number.  Again, the enigmatic sampling, poorly defined control group, narrow selection of long-term consequences, and meaningless risk numbers provide insufficient justification to give these conclusions any meaning or validity.

C.  What can be concluded from this study?

The only results that can be credibly presented are the tabulation of incidences. 

1.  Out of an unknown number of children, at least 42 who received the DTP vaccination had febrile seizures within 30 days, and at least 10 had nonfebrile seizures.

2.  Out of an unknown number of children, at least 32 who received the MMR vaccination had febrile seizures within 30 days, and at least 3 had nonfebrile seizures.

3.  Out of an unknown number of children, at least 413 who had febrile seizures did not receive either the DTP or MMR in the preceding 30 days.  At least 124 children who had nonfebrile seizures did not receive either the DTP or MMR in the preceding 30 days.

Because this paper fails to meet minimum scientific standards for the presentation of objective evidence, no other conclusions are defensible. 

------------------------------------

Originally posted on 12/8/02 (Revised 12/11/02).

The author would like to thank the Vaccine Science discussion list for their input and feedback.

http://groups.yahoo.com/group/VaccineScience/

Cervical Cancer Vaccine -- A Shameful Example of How Medical Research is Taking Dangerous Short-Cuts
By Nicholas Regush  http://www.mercola.com/2002/dec/11/cervical_cancer.htm


Whenever you see or hear the word "breakthrough" in a medical news report, duck for cover. Chances are someone’s imagination is hard at work.

The latest medical frenzy involved a vaccine aimed at cervical cancer.  The study was published in the November 21 issue of The New England Journal of Medicine (NEJM).

The Reuters News Agency provided this lead: "A vaccine against a cervical cancer-causing virus can protect young women from infection - a success researchers hope will eventually allow them to prevent many cases of cervical cancer."

The virus referred to is the human papillomavirus (HPV).

Reuters quoted Dr.  Christopher P.  Crum of Brigham and Women’s Hospital in Boston as saying: "This is a great study."

Let’s move on.

CBSNews.com’s headline asked the question: "Major Cancer Breakthrough?"

Then the report proceeded to quote researchers in this manner: "It’s really the first time that a vaccine has been shown to prevent directly a pre-cancerous condition and indirectly a cancerous condition." That quote was attributed to Dr. Carol Brown, a gynacologic oncologist at Memorial Sloan Kettering Cancer Center in New York.

Over at the New York Times, at least the headline was more circumspect: "Experimental Vaccine Appears To Prevent Cervical Cancer." The "deck" or the line underneath the main headline might have read this way:
"Appearances Can Be Deceiving." However, the Times chose to report: "The vaccine works by making people immune to a sexually transmitted virus [human papillomavirus] that causes many cases of the disease."

The Times quoted Dr.  Laura A.  Koutsky of the University of Washington in Seattle, the study’s director, as saying: "These are tremendous results."

The Chicago Tribune bought the study too.  Its lead paragraph referred to the fact that "after decades of failure," scientists showed early success in preventing human papilloma infection, "which is linked to cervical cancer."

Really?

First, Some Background And A Question Raised Cervical cancer, arising in the lining of the cervix, affects about 13,000 women in the U.S.  each year.  About 4,000 die.  Worldwide, a half million get the disease and 225,000 die.

Back in the 1970s, herpes simplex virus (HSV) was proposed as the sexually-transmitted cause of cervical cancer, based mostly on population studies that showed a correlation of the disease with HSV DNA.  That approach shifted to HPV in the 1980s, and over the years population studies set the pace for the now well-accepted view that cervical cancer is strongly related to the transmission of HPV.

This is a group of more than 100 viruses, about 30 of which are said to be linked to cervical cancer. Of these 30 or so, HPV-16 is said to be found in 50 percent of cervical cancers.  HPV-18 accounts for another 20 percent.

In addition to the population studies that link HPV to cervical cancer, there is, for example, research showing that HPV viral DNA can be found integrated in the genetic structure of cervical cancers.

Back in 1992, however, a question was raised about the dominant and increasingly entrenched theory that HPV causes cervical cancer.  It came from Peter Duesberg and Jody Schwartz, molecular biologists at the University of California at Berkeley.

Among the various issues they raised about the acceptance of HPV as the cause of cervical cancer was their fundamental concern that there was a lack of consistent HPV DNA sequences and consistent HPV gene expression in tumors that were HPV-positive.  They instead suggested that "rare spontaneous or chemically induced chromosome abnormalities which are consistently observed in both HPV and HSV DNA-negative and positive cervical cancers induce cervical cancer."

In short, Duesberg and Schwartz were pointing to the possibility that "carcinogens may be primary inducers of abnormal cell proliferation rather than HPV or HSV." And here’s the key point: "Since proliferating cells [cancer cells dividing wildly] would be more susceptible to infection than resting cells, the viruses would just be indicators rather than causes of abnormal proliferation."

The concept they raised back in 1992 is still relevant today; only science has gone on to assume that causation of cervical cancer has been well established.  Even the National Cancer Institute (NCI) says that "direct" causation has not been demonstrated; however, the NCI and just about everyone else works with the principle that it has been established.  Lip service is paid to other possible factors that may be involved in cervical cancer such as environmental conditions, including smoking.  Even dietary factors -- particularly low levels of Vitamin A and folate -- have been suggested as associated with a risk for cervical cancer.

But once a vaccine to prevent HPV infection is raised as a weapon to prevent cervical cancer, then it’s pretty clear that the medical Establishment has gone all the way in accepting a theory.  And it’s also quite evident in some of the comments listed above that have been made to reporters.

The headline to the accompanying editorial to the study in the NEJM screams out:

"The Beginning of the End for Cervical Cancer?" This editorial is more or less an ode to the research published. But the published research doesn’t necessarily deserve any praise.  Why?  Because the study is a disgrace. A Worthless Study When I first reviewed the study, I couldn’t believe the NEJM was putting this research on such a high footing -- and that includes the embarrassing editorial.

Essentially this is what the study is about: Of 2,392 young women who were entered into the study, 859 were excluded from the final data analysis -- some for technical reasons and the vast majority because they were actually found to be infected with HPV-16 before getting the vaccine. Of 1,533 women who remained, half were given the vaccine and half the placebo shot.

The results were as follows: No one who was vaccinated developed an HPV-16 infection or a precancerous growth.  Of those who received the placebo shot, 41 women became infected with HPV-16, and nine of them had precancerous cervical growths. On the surface, at least interesting for an early study.  But those results became the focus of great jubilation.

But I’ll tell you this: It doesn’t take a rocket scientist to see that the study’s methodology is flawed to such a degree that it doesn’t even deserve to be published in some throwaway journal.  But then again, the NEJM has, of late, become a depository for bad science.

Still, given that the entire world of health journalism seems to have piled on the bravos for this study and just about every vaccine specialist has come out of the woodwork to applaud yet another vaccine effort, I figured that I would seek out someone who has the guts to face up to the bilge that masquerades as science.  I therefore got hold of Howard Urnovitz, who is a scientist dealing in molecular issues and a regular contributor to redflagsweekly.com.

His first reply was that "this is a poorly designed study that fits all-too-well into the legacy of medical incompetence called vaccine research." Here is what Urnovitz had to say, pretty well reaching the same conclusions that I reached upon careful review of this study:

"These investigators initially enrolled 2,392 women to take part in the study.  Immediately, 36 percent were disqualified primarily because they had detectable HPV markers, according to the study’s authors, who determined HPV-detectability by either antibody or PCR testing.  In other words, the study selected for women who showed some sort of robust natural immunity that kept them from expressing the HPV markers.

Then the study used a cancer detection method which is known to be inaccurate, with a rate of false negative test results that ranges from 1 percent to 93 percent, despite the fact that it is the only test currently available in the United States to screen women for signs of cervical cancer.  (A false negative result means that women who have cervical cancer or precancerous tissues are not being identified when they have a Pap smear.)"

The women in this study are only monitored for HPV infection if they show a positive Pap smear. But since even the CDC recognizes that the Pap test produces a wide range of false negative results, the HPV study’s foundation -- the Pap test -- is so unreliable that the rest of the study is rendered highly suspect.

"Also, the HPV test is poorly designed.  A positive result was defined as any PCR signal that exceeded the background PCR level associated with an HPV-negative sample of human DNA.  This is a risky protocol because PCR tests are plagued with false positive reactions (a positive signal that is not a true detection of the target). Since the authors show no data or reference to data on a secondary test that confirms the gene sequence of a positive signal, they cannot conclude that they are measuring HPV." So here is what the study really amounts to.  Again, I’ll defer to Urnovitz because he lays it very cleanly on the line:

"The proper conclusion of this study should be: Administration of this HPV-16 vaccine reduced the incidence of an uncharacterized PCR signal from a poorly defined cohort which was strongly biased toward a natural immunity.

Finally, press suggestions or those from the authors that young girls will soon be given a vaccine to prevent cervical cancer are ridiculously premature.

As an aside (make of it what you will), given the great new honesty in medicine these days, it was noted in the NEJM that "some co-authors on the study are with Merck Research Laboratories which developed the vaccine and provided the funding."

Red Flags Weekly November 25, 2002

DR.  MERCOLA'S COMMENT:


Wouldn’t it be nice if we could just get a shot, or in the future just eat a plant that is reengineered to contain a vaccine that would rid of us cancer?  Of course it would.

Unfortunately that is not the way our bodies were designed.  Cancer prevention is not as simplistic as taking a vaccination.  Maintaining a high level of immune integrity is the key, and this is done through the basics of emotional balancing, optimized nutrition, avoidance of toxins, proper sleep, exercise and hydration.

This research is clearly another deceptive ploy by Merck to generate revenue for their vaccine division in exchange for the delusional hope that a vaccine will reduce the risk of cancer.

Nicholas Regush writes an excellent review on this topic, which he is quite familiar with as a result of his review of the literature on HHV6 for his worthwhile book The Virus Within.

 

Parents fear possible vaccine link to autism

Monday, December 30, 2002

By MARK PERKISS

Sharon Oberleitner is facing a parent's nightmare.

She's convinced her two children developed autism because of vaccines they received and believes that having them immunized against smallpox will make their conditions worse. "I'm hoping there's not a war with Iraq and that there isn't any use of biological weapons," said the Princeton Township resident.

"I don't want to have to make a decision on whether to vaccinate my children and put them at risk, but I don't want them to get smallpox either. It's very scary," she said.

President Bush's move toward resurrecting wholesale smallpox inoculations for the first time since the 1970s comes as the nation's vaccination program is under increasing questioning - mostly from parents of autistic children. Questions abound whether the vaccines themselves or thimerosal, a mercury-containing preservative used in many of them from the 1930s until 1999, may be a cause of autism, a neurological disorder that can leave children unable to communicate with or relate to other people.

The debate rages in scientific circles, courtrooms and the halls of Congress, where lawmakers last month mysteriously slipped into the homeland security bill signed by Bush a provision protecting Eli Lilly & Co., the maker of thimerosal, from lawsuits.

But the head of the Eden Family of Services in West Windsor, one of the nation's leading treatment centers for autistic children, said parents' concerns about vaccines are unfounded and that the benefits of inoculations far outweigh any risk they may present.

"There are a lot of myths out there about vaccines and autism," said Eden President David Holmes.

"You have parents who are desperately searching for answers as to why and how their children have autism," he said. "There is a small, but vocal faction that sees vaccines as a culprit. "They were focused on the MMR (measles-mumps-rubella) vaccine as a cause, but scientific studies have shown there is no link. Now they're focused on the thimerosal, and so far the studies are showing there's not an autism link there either," Holmes said. "You can't help but feel for them. They're clutching for whatever they can, but there's a much larger consideration."  Recent studies, including one of 500,000 children in Denmark published in the New England Journal of Medicine last month, have found no link between the MMR vaccine and a dramatic rise in autism cases in the United States.
 

And a small, but groundbreaking study of infants who received vaccines containing thimerosal published in a British medical journal earlier this month found the levels of mercury in their blood was within federal safety limits. Parents and some scientists have theorized that a buildup of mercury from vaccines may have led to children developing autism. Holmes said the question of the effect of mercury in vaccines needs to be explored further but said he is looking at the larger picture.
 

"You have to look at the millions and millions of children in the United States who have been saved from a slew of devastating or fatal diseases because of our vaccination program," Holmes said. "That's a far larger number than any children who have had bad reactions from the vaccines. "There are always questions when you talk about vaccines, and those should be investigated and answered to make the program safer, but the overwhelming benefit of these medications far exceeds any risk there may be." Holmes said he is not concerned about the prospect of the United States resuming a smallpox inoculation program. "There's a legitimate threat from biological weapons, and we should be prepared," he said. "Children who already have autism aren't going to become worse if they are vaccinated for smallpox," Holmes said. "Autism doesn't get worse." 

Smallpox has not been seen for decades, but officials fear it could be used in defense by hostile countries or as part of a terrorist attack. The last U.S. case was in 1949, and the last anywhere else in the world was in 1977. The disease was declared eradicated globally in 1980. Routine smallpox vaccinations for children in the United States ended in 1972. So far, Bush has ordered about 500,000 military members in high-risk areas to receive the smallpox vaccine and has said vaccinations will be made available to about 500,000 health care workers around the country.

While he is not yet calling for all Americans to receive the vaccine, Bush has said those who want it will be able to get inoculated in 2003. The move to restart the smallpox vaccination program coupled with questions by parents and researchers about the possible link of thimerosal and autism has been music to the ears of trial lawyers, who have filed lawsuits against Eli Lilly and other manufacturers and are looking to drum up additional clients for what they see as billions of dollars in damage claims.  "What we have at the moment is a temporal correlation, which is enough for us to look to find potential plaintiffs," said John Sakson, the co-managing partner at Stark & Stark in Lawrence, which is working with a Texas law firm and earlier this year ran television ads seeking parents of autistic children as clients for possible lawsuits.

Stark & Stark signed up hundreds of potential clients but has not yet filed any lawsuits. "We need to make sure the science is correct for us to make a claim, and then there's the matter of the lawsuit protection that Congress put in for Eli Lilly," Sakson said. "That will have to be tested first."  Under the legislation, thimerosal claims would be limited to the federal Vaccine Injury Compensation Program, which limits damages and severely restricts who can sue vaccine manufacturers. Members of Congress are working to lift the litigation protection that was included in the homeland security legislation. "We've had a number of meetings with parents groups and with other members of Congress to see what we can do about it," said Nick Manetto, a spokesman for Rep. Chris Smith, R-Washington Township. Smith voted in favor of the legislation but was unaware of the provision that was included in the bill at the last minute, Manetto said. All of the legal and political maneuvering doesn't solve the pending dilemma for Oberleitner, the Princeton Township mother. "Vaccines are scary. My children are suffering because of them," she said. "Smallpox is scary also. "If it actually gets to our shores, I don't know what to do. I thought I was protecting my children with the vaccines they've already had, and look what happened."

NOTE: Contact Mark Perkiss at mperkiss@njtimes.com or at (609) 943-5727.

Copyright 2003 NJ.com. All Rights Reserved.

The Danish MMR-Study- a critical analysis

http://content.nejm.org/cgi/content/abstract/347/19/1477?ijkey=p4J.EJxP2/wIk

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism
Kreesten Meldgaard Madsen, M.D., Anders Hviid, M.Sc., Mogens Vestergaard, M.D., Diana Schendel, Ph.D., Jan Wohlfahrt, M.Sc., Poul Thorsen, M.D., Jørn Olsen, M.D., and Mads Melbye, M.D.

ABSTRACT

Background It has been suggested that vaccination against measles, mumps, and rubella (MMR) is a cause of autism.

Methods We conducted a retrospective cohort study of all children born in Denmark from January 1991 through December 1998. The cohort was selected on the basis of data from the Danish Civil Registration System, which assigns a unique identification number to every live-born infant and new resident in Denmark. MMR-vaccination status was obtained from the Danish National Board of Health. Information on the children's autism status was obtained from the Danish Psychiatric Central Register, which contains information on all diagnoses received by patients in psychiatric hospitals and outpatient clinics in Denmark. We obtained information on potential confounders from the Danish Medical Birth Registry, the National Hospital Registry, and Statistics Denmark.

Results Of the 537,303 children in the cohort (representing 2,129,864 person-years), 440,655 (82.0 percent) had received the MMR vaccine. We identified 316 children with a diagnosis of autistic disorder and 422 with a diagnosis of other autistic-spectrum disorders. After adjustment for potential confounders, the relative risk of autistic disorder in the group of vaccinated children, as compared with the unvaccinated group, was 0.92 (95 percent confidence interval, 0.68 to 1.24), and the relative risk of another autistic-spectrum disorder was 0.83 (95 percent confidence interval, 0.65 to 1.07). There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autistic disorder.

Conclusions This study provides strong evidence against the hypothesis that MMR vaccination causes autism.

BMJ 2002;325:1134 ( 16 November )

News

MMR vaccine is not linked with autism, says Danish study

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537,304 children in the study, 8 cohorts