It has been clear for months now that CISA has no intention of investigating the HPV vaccine question aggressively in Jenny's case--or perhaps in others. Meanwhile Jenny's condition gets graver by the day . So, posting a debate about the quality of other CISA investigations is becoming necessary. The concerns fall into the following six categories:
(1) Gardasil was the vaccine that Jenny received shortly before symptom onset--not Menactra. It is unclear therefore why her case was directed to a doctor who had researched GBS-Menactra connections. Even if the adjuvants were identical, the VLPs (hypothesized to be one possible disease trigger) are different. Perhaps most importantly, as the FDA warning letter of April 28, 2008 to Merck on manufacturing process violations reveals, there are grounds for concern about the quality of the lot numbers of Gardasil that our Jenny may have received - grounds that could extend to either the adjuvant or the VLPs.
(2) Even if the correct vaccine had been investigated in the VAERS database, it is unclear that any effort was made to contact MDs who treated the most potentially similar cases. Was such an effort made? And did it take into account such hypothesized pre-existing vulnerabilities in Jenny's case as the presence of pre-vaccination autoimmune diseases (such as pityriasis lichenoides in Jenny's case) and genetic or mitochondrial predispositions (such as a maternal line that includes tauopathy in maternal grandmother and severe autism and seizures in a maternal cousin)
(3) Insofar as Jenny's symptoms appear to have unfolded more gradually than those for most cases of GBS, and insofar as it is hard to set an exact date of onset for Jenny's symptoms (you can apparently lose quite a few motor neurons before it becomes apparent to the untrained eye), there is a real danger that parents and MDs may not link the vaccine to the later emergence of relatively full-blown ALS-type symptoms. Was any effort made to determine whether there has been a spike in motor-neuron-disease symptoms among girls/adolescents in a broader database that does not require perceived possible linkages to vaccines - and then to link back to possible vaccination antecedents? The base rates for MND among girls in Jenny's cohort are extremely small - so this would require access to a large database (one of the reasons we have extended the search for comparables to Jenny's case cross-nationally).
(4) At earlier stages of Jenny's illness - as late as January 2008--she would have probably been classified as some form of GBS (MMN or motor variant of CIDP were the diagnostic bases for the early treatment decisions). It is especially critical therefore that VAERS GBS reports that leave outcome ambiguous or dangling have follow-ups to determine whether initial report captured only the earlier phases of a longer-term deterioration. Was any such effort made in the initial investigation?
(5) Apparently at least one member of the CISA committee was under the misapprehension that it was "a fact" that the onset of weakening was 45 days after the vaccination. We are curious where this fact originated. We have learned the hard way that measuring the rate of loss of strength is amazingly hard: even when Jenny has been under intensive medical scrutiny, there have been diverging assessments of the rate of her decline, and even over whether she has stabilized at various points. And we have always known how much harder it is to quantify retrospectively the onset and rate of weakening in a time period when one did not remotely suspect that a seemingly healthy adolescent girl was weakening. The new CISA committee should be informed that the exact onset of weakening and functional form of the weakening over time is uncertain but that reasonable guesses would date it back to the spring of 2007. (To illustrate the absurdity of positing a known date for an illness of Jenny's sort, suppose that our daughter has been losing motor neuron control at the deeply depressing rate of about 5% per month since the last vaccination. What percentage of parents would notice such a decline in their teenage children within the first one or two months--and if they did notice it, what percentage would attribute their observations to mood or minor illness or...?)
(6) Finally - and we realize this concern is not peculiar to Jenny's case - VAERS is likely to undercount claims due to a mix of factors, including the voluntary nature of the reporting and the effort it requires from busy professionals and the likelihood that many people may not notice the temporal link between vaccination and onset of symptoms (obviously this becomes more problematic, the greater the delay--per points #3,4 and 5). Overall, this undercounting means there will often be a lag in attaining statistical significance even when there is a causal relationship. Moreover, even with this obstacle, the Gardasil-GBS covaraition appears already to have passed statstical significance. Were any statistical analyses conducted with respect to Gardasil?
The follow up has been disappointing and we continue to struggle for answers.