Need for more and better studies designed to identify vaccine risks

Institute of Medicine call for research needs (1991)

In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines.  These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation.  The committee found few experimental studies published in relation to the number of epidemiologic studies published.  Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped (emphasis mine).

Institute of Medicine Testimony by Sandy Mintz (1993)

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.