As I sit in the Reagan Airport in D.C., I am compelled to share with our community my thoughts regarding the CDC’s H1N1 stakeholder’s meeting held September 10th and 11th that I was invited to attend on behalf of SafeMinds. This meeting was the last in a series of public engagement meetings to discuss novel H1N1 (swine) flu vaccine concerns and vaccination program implementation. There were a number of familiar faces in the room from the Immunization Action Coalition, Every Child by Two, Department of Defense, American Academy of Family Physicians, National Vaccine Advisory Committee (NVAC), U.S. Health & Human Services and of course the sponsor, the Centers for Disease Control (CDC). Many representatives from state health departments and a few migrant and minority organizations representing the need for equal access to vaccines rounded out the group.
I can honestly admit, I was unsettled by what I suspected would be a meeting with few representatives from the vaccine safety concerned community – which was the case. The meeting was by invitation only and SafeMinds and Barbara Loe Fisher from the National Vaccine Information Center were the sole representatives for the vaccine concerned community in a room of 43 other stakeholders. Chief among my concerns was how, with little representation, would our voices be heard? Everyone was respectful and had an opportunity to comment and ask questions.
This was in part a replication of the citizen public engagement meetings held in August. Stakeholders were given the same set of assumptions and information as the previous citizen groups and worked in small facilitated breakout sessions to discuss scenarios for levels of effort regarding rollout of the vaccine program. Implementation scenarios were “Go Easy” - designed to meet an expected low public demand for vaccine, “Moderate” would aim to raise the expected low demand for vaccine and “Full Throttle” to respond to significant vaccine demand with extensive communication activities in an effort to feel safe and not sorry.
Out of the 1,056 citizen participants from the 12 public meetings 23% voted for Go Easy, 52% Moderate and 25% Full Throttle. By contrast, the stakeholder group voted 3% - Go Easy, 40% - Moderate and 57% - Full Throttle. Upon discussion, it quickly became apparent that preparedness was the focus due to the many public health officials present. All felt safety was important, but Barbara and I were likely the only ones, outside federal representation, that had an appreciation for the gaps in vaccine safety research that exist, as defined by the National Vaccine Advisory Committee. Thus, there were conclusions on the part of many public health officials that safety was indeed assured. So much so, that many in the meeting thought the disparity in polling between citizen groups and the stakeholder group was the result of misinformation from “fringe groups” hampering communication efforts. These sentiments were quickly followed by requests for CDC to do more consistent messaging, with some wanting to find a way to “work around” those expressing opposing views.
It was at this point that I expressed that this was an opportunity to understand that “our” safety concerns were legitimate and that we didn’t want to be “worked around”. I added that the number of individuals with vaccine concerns continues to grow and that what we want embraced is long-term improvements to vaccine safety research currently recognized as seriously deficient instead of being dismissed in favor of the “greater good” - there is room and an obligation to both safety and serving the greater good and that should these concerns remain unaddressed, distrust in vaccines would increase.
Barbara Loe Fisher of NVIC made the very salient point early on that public health officials should treat vaccine injuries with the same respect and seriousness as injuries resulting from vaccine preventable disease and that CDC’s response to H1N1 flu should reflect the reality of the situation and the need for truthful communications to the public. She also questioned Lance Gordon, former NVAC member, on the availability of information regarding if NIH and vaccine manufacturers will be studying the effects of H1N1 vaccine in pregnant women and children whose health is compromised, given their identification as a target group for this vaccine. Dr. Gordon stated that studies on pregnant women were underway, however, that no studies on sick children were being conducted and added that "we can't know what the risks are for those populations until it is used on a widespread basis." Clement Lewin, a Novartis representative, stated that testing with asthmatics was underway. Barbara underscored the need for this information, as well as any information, on what is known and not known to be given to the public, a recommendation also echoed by the NVAC’s H1N1 Vaccine Safety Subgroup.
Given the data coming out of Australia demonstrating that the H1N1 virus has not mutated and is causing fewer deaths and complications than other flu strains, Barbara followed up with Dr. Anne Schuchat of the CDC, by asking if the CDC would consider removing the health emergency declaration enacted this past April. Dr. Schuchat responded that the H1N1 swine flu was causing death and complications just like regular influenza and that is very concerning and terrible and that people need to know how bad it is and the need to get vaccinated and that the CDC would not be rescinding the declaration.
Other information from the meeting…
• with the possible exception of children 9 years old and younger, one dose of vaccine should be sufficient and this news in effect, doubles vaccine available and should take unlicensed adjuvant off the table (hopefully);
• Thimerosal free vaccine will be widely available, however, no preference statement will be forthcoming. In following up with Dr. Anne Schuchat, privately, after she ducked answering my questions of how using a vaccine exceeding EPA safe exposure guidelines for mercury could be justified, Dr. Schuchat indicated that the science on thimerosal is done. She added that in acknowledgement of public’s concern, thimerosal free would be available. It was also made clear that the promise made ten years ago to remove thimerosal “as soon as possible” would not be kept if Dr. Schuchat has any say in the matter;
• Studies are being conducted on giving the H1N1 with seasonal flu vaccine and separately, but their completion date is unknown, as is the length of look back on adverse events and if adverse events will focus on more than immune response;
• Live virus vaccine (FluMist and H1N1 nasal mist vaccine) will be given separately, as they may not work when given together;
• VAERS and VSD are being beefed up (no specifics) and admission of deficient infrastructure acknowledged;
After a very long two days, I participated in focus group afterward and posed the question - how many had read the NVAC’s review of the CDC’s Immunization Safety Office Draft Research Agenda or the NVAC’s H1N1 Subgroup recommendations - and was not surprised that none had. However, I stated that I had read it and suggested that the vaccine concerned were actually a very knowledgeable bunch in many instances and worthy of engaging in discussion. A representative from New York summed it up best during the focus group interview, that for some reason we are often talking past each other. I reiterated that our goal was the same as theirs - the safest vaccines possible and that the NVAC report and the H1N1 subgroup recommendations might provide a starting point for dialogue. It was apparent that safety was the common ground that we shared, although its status in relation to vaccine safety appeared to be largely unknown by our local health officials, due to their reliance on CDC as the one and only authority on safety and the perception that they are beyond error or conflict of interest.
This is just the tip of the iceberg in my opinion of the trust that CDC enjoys and the lack of awareness among our public health officials as to what is known and not known with regard to the status of vaccine safety research and their unfamiliarity with the foundation of our resistance and distrust. I also suspect that many are very unaware of the conflicts of interest in vaccine promotion and the conducting of safety research on which CDC hangs its hat, particularly true where thimerosal is concerned. Very noticeably, stakeholders throughout the meeting nodded their heads in agreement, as did Barbara and I, on the need for safety and clear communication. The departure in what “safety” and “clear communication” meant stemmed from how educated the individual was and whether they had dug deeper than the CDC’s press releases and press conferences held on any vaccine effort or publication of any research, or similar pronouncements from professional organizations, etc.
Of encouragement is that those of us participating in the focus group felt that more citizen representation was necessary in future stakeholder meetings; a sentiment that also had support from other stakeholders in the course of the larger discussions. I suggested more organizations with vaccine concerns be present, as well as the vaccine injured and attorneys representing them and was met with what appeared to be agreement.
What I have come away with is a better understanding of logistics that face our local public health officials in assuring public safety and that many want to use this vaccination effort as an opportunity to put infrastructure in place from the standpoint of preparedness, whether for a pandemic or hurricane. It is also imperative that constructive dialogue with local officials transpire to bring an awareness of the legitimate safety concerns that exist with regard to vaccines and the critical gaps in safety research that must be remedied. These were human beings that I shared two days with who felt that we were in this together, even though there were varied degrees of understanding what “this” was. Though they voted from a preparedness standpoint, many also listened to Barbara and me and only a few rolled their eyes.
I have no illusions of how steep the grade is on this journey or how it will continue to be fraught with putting down paternal messaging from CDC – paternal messaging were words from public health officials by the way, not me. It will require that untruths be put down as well, and as I look into the faces of my daughters, Deanna and Rachel, who’s first words on my return weren’t “We’re so glad you’re home”, but “How did it go?” my response was “We’ll wait and see.” It was the same response I gave to the focus group’s last questions - Did I think CDC would use the information from the public engagement? I clarified my meaning by adding that for the community I represent, we have regularly engaged with public health officials and are waiting to see how safety will be improved and not just for this vaccine effort, but in light of the NVAC report and others, in the use of vaccines in general and that we had been waiting ten years or more for improvements. “Talk is cheap, actions speak louder than words.”
Many thanks to Barbara Loe Fisher for her continued and longstanding efforts via NVIC. Barbara was positively recognized at the outset of the meeting by CDC’s Dr. Roger Bernier for her continued public engagement efforts and it was very good to have her company on the vaccine safety frontier.
Theresa Wrangham is the mother of Rachel, a teenager who is diagnosed with PDD/NOS, and Deanna. She lives in Colorado with her husband, Scott. She brings to the fore an experienced parent's perspective on raising a healthy child affected by ASD and the benefits of advocacy outside family needs. Theresa was appointed to the Board of SafeMinds in 2007 and currently serves as president. She served as a past Board Member with the Autism Society of Colorado and co-founded the Autism Society of Boulder County (ASBC), serving five terms as president. She is currently the immediate past president. Theresa is also the Director of Educational Development and Conference Liaison for the US Autism & Asperger Association.