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Institute of Medicine Testimony, January 16, 1993

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Thank you for allowing me to speak.

My name is Sandy Mintz and I live in Alaska.

The points I would like to raise in my testimony today revolve around 3 main areas of concern: 1) problems with the 1991 report I hope the current committee can avoid, 2) specific concerns about vaccines, using measles as a model, and 3) suggestions for the direction and design of future vaccine safety and efficacy research.

In the 1991 IOM review, the Committee quite fairly pointed out that it had been handicapped by the lack of adequate studies, including the poor design of many.  The Committee also properly concluded that the absence of appropriate studies meant that there was insufficient evidence to indicate whether or not there was a causal relationship between many of the adverse reactions being studied and vaccination.  Imponderably, however, similarly flawed information was cited as evidence AGAINST causality in their report in a number of instances.

The Committee's conclusions concerning SIDS and DPT vaccine are a case in point.  Although they admitted in their review, and I quote, "Prior to the 1960's, little was known about the epidemiology of sudden infant death syndrome (SIDS)", they concluded, and again I quote, "Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DPT immunization typically occurs".  Without information on the background rate of SIDS in historically, socioeconomically, and otherwise comparable never vaccinated groups, data on the expected frequency of SIDS merely reflects its incidence among vaccinated populations, rather than absent vaccinations, and cannot be considered accurate or meaningful.  Given that such background information was not presented by the Committee, conclusions about the absence of a relationship between SIDS and vaccination were not justified.

Nor were any studies cited - in fact, to my knowledge none exist - in which the only proper control group, never vaccinated children, was used.  If, as is the case in most studies, "less recently", but nonetheless vaccinated, children were used as controls, and an adverse event can be either a delayed or long-term consequence of vaccination, one would EXPECT to find no differences between the study groups, even if vaccination HAD caused an adverse event.  Conclusions about causality drawn from any study with such serious limitations are not justified.

The fact is, all controls are not equal.  More importantly, many groups are improperly designated as controls.  The 1991 IOM statement that a nontreatment group, i.e., control, might be one using an established alternate vaccine, is an example of an improper definition of a control.  In no way can any form of vaccination, whether "established" or less recently administered, be considered lack of intervention.  The extent to which various established vaccines and times since administration of vaccine are similar to non-vaccination should be studied, not assumed.  Only a placebo, which in the case of vaccination studies equals the absence of vaccination, is appropriate.

As to the notion that it is unethical to withhold vaccination due to "widespread acceptance" of vaccination, I would submit that to the contrary, if anything, it is unethical to administer vaccinations of unknown safety and efficacy.  It is unsound to argue we can't withhold vaccines because of "widespread acceptance", as the 1991 IOM Committee did, when the reason there is such widespread acceptance of vaccinations is that we have been told the vaccines are safe and effective.  Their argument is particularly ironic given their finding that serious consequences can result from the two vaccines, and lament about the absence of adequate information.  To the contrary, the conclusion that must be drawn from their review is that randomized, long-term, placebo-controlled, prospective clinical trials are urgently needed, in spite of ethical concerns about ADMINISTERING vaccines of unknown safety.  Indeed, no reassuring claims about the infrequency of any linked adverse event should be made until and unless the false premises underlying study designs and the many study design flaws, including the lack of reasonable and time appropriate controls, and reporting system inadequacies, are corrected.

Please note that in any study of long-term vaccine consequences, in which proper experimental and control groups are used, a comprehensive and longitudinal medical assessment is necessary in order to discern all observable and measurable effects of vaccination, both good and bad, known and unknown.

An insidious way in which the risks of vaccination can be incorrectly estimated is by using the number of doses of vaccine which appear to result in injury, rather than the number of children that are administered how ever many doses it takes to injure them.  Since nearly all vaccines are currently being recommended to be administered in multiple doses, using doses rather than children can result in gross underestimation of actual risk.  We also cannot ignore confounding which occurs when high-risk children are eliminated, either by not receiving the vaccine in question at all, or by receiving only one dose.

Take as an example convulsions resulting from either whooping cough vaccine or whooping cough.  The CDC says that 1/1750 vaccinations result in convulsions but that 2/100 children who get whooping cough have convulsions.  If we divide the 1750 vaccinations by the between 4 and 5 doses children are required to get, the result is 1/350 to 1/438 children getting convulsions after whooping cough, not nearly as dramatic a difference.

If we further try to factor in the impact of underreporting of adverse reactions, the actual incidence of which is unknown but presumed to be significant, it becomes clear that there may be no difference, and in fact, that it is possible convulsions are more likely to result after vaccination than after disease.

The fact is, however, that we do not know the true incidence of vaccine adverse reactions, of whooping cough itself, of convulsions after whooping cough or many other relevant and critical factors, including the actual number of children receiving a vaccine once high-risk children have been removed.  We should simply admit it and set about trying to learn what we can.  We should not, however, be issuing reassuring assessments of vaccine risk.

When evaluating the risks of vaccines, it is imperative that we look at the big picture.  We simply cannot accurately evaluate vaccine benefits or risks in a vacuum, nor consider the evaluation static. Among the many things which need to be considered are the following:

The true risk of contracting a disease, in comparable, never vaccinated populations, as well as the true risk of suffering serious consequences from a disease, must be determined.  Included in any such analysis should be historical morbidity and mortality data from years prior to the introduction of vaccines, preferably smallpox vaccine.  When considering the true risk of long-term serious consequences of disease, new treatment strategies, like erythromycin for whooping cough, and vitamin A for rubeola, should be factored in as well.

2)     The background rate of an event occurring in comparable never vaccinated populations, should be compared to recently and not so recently vaccinated ones.  However, as useful and important as background rates are, when making comparisons between groups, such rates should never be used to substantiate claims about whether or not a particular child suffered "residual effects" from some untoward event following vaccination, since a particular child's potential can never be predicted.  This holds especially true when estimating an infant's potential.

3)     Graphs should be presented fairly, and if they have not been, primary data, rather than graphs, should be used.  Included in my submissions is a graph found in the MMWR which provides an excellent example of the dangers of their unquestioned use and "how to lie with statistics".  The Y axis uses an inappropriately applied logarithmic scale, the result being that drops in both morbidity and mortality prior to vaccination are made to appear insignificant, while drops occurring post-vaccination are made to appear dramatic.  In fact, the opposite is true.

We also cannot ignore the impact of vaccines on changing epidemiology when considering their risks and benefits.  For instance, measles may have been made a more serious disease because of measles vaccination.  Prior to widespread vaccination, once a population had been exposed to measles, few adults or infants contracted it, adults due to lifelong immunity and infants due to maternal antibodies.  Now, adults AND infants are getting the measles, with serious consequences.  I would like to include reference to a recent Washington Post article entitled:

"Measles Still Menace to Infants: Vaccinated Moms Pass Less Immunity to Babies".  In this article it was noted that although in 1976 3% of measles cases occurred in children less than one, today more than 25% do.  The author also indicated that prior to vaccination, 3 to 4 million measles cases occurred with around 500 deaths.  This would make the case-fatality ratio for that period between 1 to 2 per 10,000.  In the years 1989, 1990 and 1991 combined, however, it was reported that around 55,000 people got the measles and 165 died, making the case-fatality ratio dramatically higher at 3 out of 1,000.  At this rate, fewer than 175,000 cases per year would be necessary to result in the same number of deaths which used to occur when there were millions of cases.

The CDC says that, although worrisome, the problem would be solved were all preschoolers vaccinated and measles virus eliminated from circulation.  Yet I would submit that with waning measles vaccine immunity a fact of life, and subclinical cases of the measles occurring among the vaccinated and considered to boost vaccine-induced immunity, vaccinating preschoolers will not prevent measles from circulating.  Indeed, an obvious major source of infection for infants and unimmunized toddlers has been properly vaccinated school-age children who developed most of the clinical measles cases, as well as many subclinical ones.  It is, in fact, puzzling that the CDC would offer such reassurances given that they have admitted even 100% vaccinated populations can have outbreaks.
The CDC also says that about 40% of mothers currently do not have protective antibodies and that at the end of the decade that figure will be 100%.  This, of course, means that as the percentage of mothers without antibodies rises, the death rate should rise as well, since an even higher percentage of cases will be infants.

Morbidity and mortality statistics for measles should also rise as fewer and fewer adults have natural immunity and more and more adults have waning vaccine immunity.  The scenario is quite believable in which mothers would get measles and pass them on to their infants, whereas before they would never have gotten the measles, and would instead of passing the measles on to their infants, have passed on protective measles antibodies to them.

In other words, measles may not be controllable, and may have been made vastly more serious, by the use of measles vaccination.  Adults, in fact, may now be faced with the unsavory prospect of getting measles or receiving a vaccine, neither of which has been proven to be safe for them.  Any risk/benefit analysis should take into consideration the impact of vaccine-program induced changing epidemiology on the seriousness of any diseases vaccines are designed to prevent, as well as the consequences, including efficacy, of vaccinating adults against what were once childhood diseases.

The problems which can be overlooked if vaccine analysis is taken out of context are well exemplified in the case of rubella vaccine.  A normally benign disease in childhood, usually affording lifelong immunity, it can result in devastating effects if a non-immune pregnant woman is exposed during the critical time period. As devastating as the consequences can be for an infant, it is important to not only determine the actual incidence in epidemic years of congenital rubella syndrome, but whether or not an unvaccinated child allowed exposure to rubella is more or less likely to be immune in adulthood than a previously vaccinated child, given that vaccine immunity is now generally thought to be short-lived.  Indeed, it is entirely possible that the risk to the fetus is greater from once-vaccinated mothers, given waning vaccine immunity, and the overall risk to the population greater, once the risks of adult rubella vaccination have been factored in.

Aside from my earlier recommendations concerning properly designed studies (and by long-term, I mean 20-30 years at least), I would also urge that you recommend some enforcement mechanism vis a vis doctors reporting adverse reactions.  Although I realize that adverse reaction reporting is an extremely flawed method, as we all know, in theory as well as in fact, and can neither be viewed as proof of causation or as exhaustive, still we need to get some idea of the range of possible vaccine consequences, as well as to follow up on those we do know about.

Among the many other questions which need to be asked and answered, I would recommend the following:
  1. Is cancer more or less likely to occur among the vaccinated?  Included in any studies should be reference to SV40, other vaccine contaminants, the role of chromosomal damage as a result of vaccination, and immune system suppression.  The notion that a subclinical case of a disease is preferable to a full-blown case should be studied, not assumed.  Submitted is a tantalizing study by Ronne in The Lancet in which he found that subclinical cases of the measles resulted in significantly increased rates of serious disease among adults.
  2. What, if anything, is the role of vaccine contaminants in causing adverse reactions and new diseases?  Included in any such studies would be the role played by such contaminants in the outbreak of AIDS and other recent immune system disorders like chronic fatigue syndrome, Kawasaki's disease and others.
  3. Why, during polio epidemics, do most people get polio, gaining lifelong immunity while apparently suffering no ill effects, while a small percentage of the population gains that lifelong immunity at a great price?  Included in any examination of this issue should be the role provocation polio and tonsillectomy play in predisposing a person to paralytic or bulbar polio, and the extent to which they each effect the incidence of serious polio.
  4. Can vaccination result in post-polio syndrome?  If it can, then we need to find out if instead of the small percentage of the population who got polio being susceptible to post-polio syndrome, whether now the entire vaccinated population is at risk.
  5. What is the effect of combining vaccines in vivo and in vitro?  Studies of this should include clinical trials of all vaccines individually, as well as the effects of their simultaneous administration.  The practice of administering vaccinations in combination without data to support their safety and effectiveness should stop until the safety and effectiveness of the practice can be firmly established.  Relevant to this discussion, and included among my submissions is a paper by Javier et al in Science magazine in which it was found that two harmless herpes viruses recombined in vivo and became extremely lethal as a result.
  6. Has a relatively small risk of long-term consequences from childhood diseases been traded for a vaccine-induced, larger risk of chronic childhood disease?  I refer you to a New York Times article I have submitted which is relevant to this question, and can, if you wish, send a journal article which describes explained and unexplained dramatic, recent increases in chronic childhood disease.
  7. Have there been real increases in behavioral and mental disorders among children, or do increases merely reflect better diagnosis?  If increases are real, has vaccination played a role, and if so, what?
  8. How effective is each vaccine?  Given that both disease morbidity and disease mortality were declining significantly prior to introduction of vaccines, the impact of the vaccines on their continued decline needs to be determined.  The effect any herd immunity might have on unvaccinated groups, as well as vaccinated ones, would need to be identified and accounted for, if possible.

In determining vaccine effectiveness, the role of replacement disease, disease renaming and other similar factors should be included.  For instance, the significance of an apparent rise in flaccid paralysis should be determined, including whether or not it represents replacement disease, or perhaps, instead, reflects a better understanding of the differences between polio and flaccid paralysis.  If polio has merely been replaced by flaccid paralysis, rather than eliminated, the success of the polio vaccine needs to be reevaluated.  If polio has been renamed, it should be determined whether or not many formerly classified cases should have instead been classified as flaccid paralysis, thereby effecting our evaluation of the effectiveness of polio vaccine in wiping out "polio".

Finally, I implore you to consider the political and financial agenda of people reading and using your report.  Please spell out, not only what conclusions may be drawn, but what conclusions may not be.

These issues dealing with research design are fundamental to whether or not reliable and valid information will be obtained on vaccine safety and effectiveness.  And while I realize that it may not be your specific charge to deal with all the issues I have raised, I hope you will do whatever is in your power to identify the problems with current, and needs for future, research in order that more meaningful and accurate evaluations can be made.
Thank you for listening to my comments.

Copyright 1993, Sandy Gottstein (aka Mintz)