The Wise Monkeys – What Federal Agencies Share with Ancient Proverb
By Theresa Wrangham
As I shared earlier on Age of Autism the results of the CDC's stakeholder meeting for the novel H1N1 “swine” flu vaccine and Monday's media advisory meeting, I am reminded of the Three Wise Monkeys.
While the origins of the proverb may be lost in time, there are some interesting perspectives that apply to vaccine concerns held by our community and how those concerns are addressed by our government...at least from my perspective. The expectation of the community with respect to this proverb could easily be summed up as the application of a noble scientific and moral code to follow, and avoidance of evil in all forms – or first, do no harm. However, its current application by government officials charged with safety and oversight of immunizations has been perverted to Hear, see, be silent, if you want to live in peace.
When it comes to admitting to the public, or public health officials for that matter, the gaps and limitations in the body of vaccine safety research it becomes apparent that the latter definition enjoys much more play by government officials – better you don't know, just trust us. The most current example would be the press advisory meeting that took place this past Monday (9/21/09) in which the most current information on the novel H1N1 “swine” flu vaccine was revealed:
- A National Institute of Allergy and Infectious Diseases (NIAID) supported study of 600 children aged six months of seventeen years of age receiving the swine flu vaccine demonstrated a 76% rate of success for immunity at a 15mcg antigen dose at 8-10 days out from administration;
- Children nine years old and younger will require two doses of vaccine;
- Nasal vaccine is also likely to require 2 doses and must be given separately from nasal seasonal flu vaccine;
- Data from studies underway on simultaneous administration of the swine flu vaccine with the seasonal flu vaccine vs. separate administration will not be available until November;
- Use of adjuvanted vaccine is not currently planned;
- Safety data on swine flu vaccine's use in pregnant women is not expected until the end of October, after the vaccine rolls out. Pregnant women have been identified by the Advisory Committee on Immunization Practices (ACIP) as a target population for this vaccine;
- There is a very good possibility that the swine flu vaccine will be incorporated into next year's seasonal flu vaccine;
On the surface it appears that gaps and limitations are being communicated. However the opposite is true, as it is little more than cherry picking enough of the information available to give the appearance of transparency. The reality is that there are many concerns that remain unaddressed that have been expressed, not only by the vaccine concerned community, but from a federal advisory panel as well. I have to admit to getting on the call for the media advisory late, so will offer apologies to Dr. Bruce Gellin of the National Vaccine Program Office (NVPO), if what I am about to write is not factual. However, during the course of the advisory meeting questions were raised about simultaneous administration and Dr. Fauci of NIAID stated that the data from simultaneous study probably wouldn't be meaningful and that making health decisions should not be delayed by waiting for this data. Dr. Gellin did not utter one word regarding the recommendations of the National Vaccine Advisory Committee (NVAC) report that had identified simultaneous administration data on vaccines in general as a critical gap in safety research needing remedy, or any other recommendations that would apply. His silence was a lost opportunity to exhibit real transparency.
The NVAC also established an H1N1 Safety Subgroup that issued recommendations for this specific effort, many of which remain unaddressed by CDC. The Subgroup's charge was to review federal plans for safety monitoring for a 2009 H1N1 influenza vaccine and provide feedback on the adequacy, strengths, weaknesses and considerations for enhancement. Unaddressed issues are:
- Development of a comprehensive and detailed plan that outlines the HHS plan for monitoring vaccine safety that includes acknowledgment of gaps and limitations on the specific studies to be carried out.
- Improved monitoring of vaccine adverse events given new antigen to be used a and development of appropriate procedures for linking dosage exposures and outcome data, as current vaccine safety infrastructure is unlikely to be sufficient to accomplish this task. CDC has stated that VSD and VAERS are being beefed up, however specifics have not been forthcoming.
- Consideration for a transparent and independent review of vaccine safety data as it accumulates by an independent group of outside experts with a charge assess risks and to advise the ASH and/or ASPR on the presence, investigation, interpretation, and implications of possible side effects of H1N1 vaccines.
Other information that isn't really making it out to the public would include that
- long-term health outcomes will not be tracked;
- data coming out of Australia demonstrating that the H1N1 virus has not mutated and is causing fewer deaths and complications than other flu strains;
- infants, young children, as well as unborn children will once again will be exposed to levels of mercury far in excess of safe exposure guidelines established by the EPA; though mercury-free versions are available;
- both the seasonal flu and swine flu vaccines are Class C drugs, meaning either studies in animals have revealed adverse effects on the fetus and there are no controlled studies in women, or studies in women and animals are not available.
As Dr. Gordon stated during the stakeholder meeting regarding studies on pregnant women underway, and that no studies on sick children were being conducted he added "we can't know what the risks are for those populations until it is used on a widespread basis." This is actually true for many vaccines and the number of people no longer content with partial disclosure in order to keep the peace is growing, as documented by the NVAC public engagements on the CDC's ISO agenda and pubic engagements from the H1N1 effort. People are instead asking for government to take the moral high ground of first, do no harm and make the necessary investments in vaccine safety research to close these gaps and honestly communicate gaps and limitations that exist.
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