The following is a response to the JAMA FDA/CDC report as requested by Diane Harper
August 16, 2009
by Emily Tarsell
A report can only be as good as the information that makes up the report. The information in this post licensure safety of Gardasil report, even by the reporter’s own admission, is greatly compromised by the inadequacies of the reporting system. Yet the reporter goes on to draw conclusions about the vaccine’s safety based on this inadequate data, and this is both misleading and dangerous.
Some of the problems with the data are as follows:
- By the reporters own admission, 68%of the responses came from Merck. Of these, 89% “do not include sufficient information to allow medical review of the cases.” That is a hugh block of missing information. There are no checks and balances about the reporting and no follow up with families to gather histories or data clarification.
- Because it is a passive reporting system, people do not know to report, especially for events that happen days or weeks after the office visit. This skews the reported events toward those made shortly after the shot, and makes it appear that if something is going to happen, it is fairly immediate. This is contradicted by the evidence I have from dozens of families.
- There is no way in the current system to capture a worsening of conditions over time and with each additional shot.
- Because the public is told the vaccine is safe and are not informed of possible side effects, people do not report events. People (including doctors) assume post-vaccine events are unrelated to the vaccine. For example, I never reported several of my daughter's symptoms because I assumed these didn’t have anything to do with the vaccine. It is only after her death and an autopsy that we realize these symptoms were all consistent with an autoimmune response to the vaccine. However none of this data is captured in this report where her death is listed as one of those “undetermined”.
- I doubt and question the number of reported deaths, particularly the number of “undetermined” deaths reported which is quoted to be four. I personally have copies of six autopsies for Gardasil related deaths prior to 2009, four of which are “unexplained.” I know there are other VAERS reports of “unexplained” deaths for which I do not have reports, so the total number of cases has got to be more than four.
- The report is inconsistent in what is being reported and measured. Sometimes it reports symptoms like syncope, dizziness, headaches and nausea. Sometimes it reports diagnostic categories like Guillain-Barre Syndrome, Motor Neuron Disorder or Autoimmune Disorders, etc. Other times, it reports conditions like Pregnancy or Death. Since there is no common denominator of what is being measured, it fragments and obscures the picture. A better picture might be obtained by recording only symptoms, by case, in relation to each shot. This would require follow up but you would then be able to compare apples with apples. (I have been gathering data from families in this regard).
- It is also puzzling to me why symptoms like seizures, numbness, muscle weakness or respiratory problems are not among the symptoms discussed. This is especially so since apparently they appeared in great enough numbers to recently prompt Merck to petition the CDC to add “respiratory, thoracic and mediastinal disorders,” “pulmonary embolus” and “syncope, sometimes associated with tonic-clonic movements and other seizure-like activity” to their list of warnings and precautions on package inserts for Gardasil.
- The diagnostic categories make it seem that the adverse effects are diverse, unrelated and in such small numbers as to be statistically insignificant. If these cases were compared symptomatically, one might see that they have a lot in common. For example, are not Guillain-Barre, transverse myelitis and autoimmune disorder all immune system related responses involving inflammation, including possible inflammation of the blood vessels resulting in insufficient blood flow? Could they not all (including pancreatitis) have a common immune related vaccine trigger that is manifesting somewhat differently depending on the systems affected? Might many of them be forms of vasculitis or autoimmune responses? Many doctors have not been able to diagnose what is happening or have changed diagnosis more than once. This suggests uncertainty about diagnostic labels. It is also amazing that vasculitis is not among the diagnostic categories mentioned.
- If seen as immune or autoimmune related responses that cut across categories, the number of adverse incidences begins to be significant. If in addition, those discounted “undetermined” deaths were researched in more detail might they also add to the numbers of immune related adverse responses? The data I have from several families suggest they would.
I cannot speak to the safety data of the pre licensure trials because I am unfamiliar with that. However, if the post licensure data collection process is modeled after the pre licensure model, then I guess the latter would have the same flaws.
With regard to the marketing of the vaccine, it is amazing how successful Merck was at pushing the right buttons to get normally rational and intelligent people to fall for their propaganda. In my case, I am normally suspect of any new drug and know to wait a few years to see how it plays out. In this case, I suppressed that instinct because they pushed the “cancer” button. Having had a sister die of ovarian (not cervical) cancer, I became anxious thinking of my daughter and the possibility that she might have a gene for such. Even though cervical cancer is different from ovarian cancer and without further research, and because her doctor was recommending it and telling us it was safe, I encouraged my perfectly healthy daughter to have the shots. She died 18 days after the third shot and I know it was the Gardasil. This was a totally unnecessary risk and we would have declined the shots in a heartbeat if we had been given any of the risk/benefit facts.
Regarding cost-effectiveness of the vaccine, it seems premature to determine this. It is unknown how long the vaccine is effective, and whether or not a booster would be required. There are, in the mean time, millions of dollars being spent on treatments for girls having adverse reactions, not to mention their pain and suffering; and the priceless loss of life for those who died.
Thank you for the opportunity to respond to these papers.