IOM, IACC & NVAC Meetings Expose Depth of Crisis of Faith in Nation’s Immunization Plan
By SafeMinds President Theresa Wrangham
What is the intersection on meetings held by the Institute of Medicine (IOM), Interagency Autism Coordinating Committee (IACC) and the National Vaccine Advisory Committee (NVAC) last week? In short, vaccine safety and a whirlwind of activity.
Monday, February 2nd opened with the third stakeholder meeting of the IOM Committee on Review of the Priorities in the National Vaccine Plan. Flying in from Colorado, I arrived late in the day and just in time to witness Barbara Loe Fisher’s voice of reason assert a parent’s ethical right to make health care decisions when asked if public health trumps an individual’s right to choose to immunize. Later, panelist Dr. Louis Z. Cooper added that communication with parents should be honest, coordinated and based on sound vaccine safety science, which to date had been “done on the cheap” and was seriously deficient. He went on to criticize the Centers for Disease Control’s (CDC) spending of $300 billion on the promotion of vaccines, while spending only $20 million on vaccine safety research. These criticisms fell on deaf ears, however, as CDC’s Media Director, Glen Nowak, recommendation was “less is more” in terms of information given to parents leaving many with the feeling that informed consent as it relates to immunization was viewed as problematic by the CDC.
The preliminary report by the IOM is available here with the next public meeting slated for April 14th in Washington to examine Goal 2 –Vaccine Safety. Click here for the agenda. The meeting will be webcast and audience comments have been allowed throughout the day and emails received during the meeting are read. Written comments should be filed anytime before the last meeting on June 4 at VaccinePlan@nas.edu and to receive updates from the IOM on this process click register.
Wednesday, February 4th, the IACC convened and discussion with regard to vaccine research was again raised during public comment by SafeMinds and Autism Speaks criticizing the recent and questionable revote to remove mandated vaccine research objectives. Invited guest, Mark Noble, PhD and Director of the University of Rochester Stem Cell and Regenerative Medicine Institute presented to the committee the limitations of epidemiological studies on thimerosal, while highlighting that research on thimerosal was more developed than that of other vaccine components and cautioned against drawing conclusions that exceed data regarding other vaccine related questions. His recommendation to the IACC was to form a workgroup within IACC comprised of scientists, advocates and clinicians who do not have an existing bias on either side of the vaccine issue to evaluate the research issues and make recommendations as to research objectives required.
Also invited to present was the Director of the National Vaccine Program Office (NVPO), Dr. Bruce Gellin, who briefly outlined the role of NVPO in their advisory capacity to the CDC, as well as their inability to perform vaccine-safety research. Wisely, Dr. Gellin stated that a clear plan was needed to restore the public’s trust in the immunization program, as trust and safety were acknowledged as concerns that exist outside the autism community. Dr. Insel stated that IACC and NVPO should work together to determine what is next with regard to vaccine objectives due to the “lack of expertise” within NIH/IACC. This statement, however, would appear to be wishful thinking by Dr. Insel. The NIH’s website clearly states “NIH has a long and fruitful history of vaccine research”. The Clinical Trials search engine reveals 433 studies using keywords “vaccine safety NIH”. One titled “Research to Advance Vaccine Safety” contains the objective - “identification of risk factors and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines.” Sounds so similar to the vaccine objectives removed from the IACC’s plan in January, doesn’t it? Collaborating organizations include NIMH, CDC, NICHD and NIEHS – all agencies that have representation on the IACC.
In referencing these websites in our public comment and stating our discontent with the unjustified stripping of the vaccine objectives from the plan, Dr. Insel stated that there were objectives within the current strategic plan that would encompass vaccine research, if the committee chose to pursue them. What is lacking from this dialogue is the IACC’s acknowledgement that vaccine research is not optional; the Combating Autism Act colloquy statements are clear in this regard and Federal representatives on the IACC continue to duck their responsibility. It also doesn’t appear to matter that the basis for the removal the previously approved vaccine objectives that was engineered by Federal IACC members have been shown to be without merit, as after our public comment it was again acknowledged that the plan contains objectives that can address vaccine issues. The notion that NIH can have their cake and eat it too is not likely to enjoy the autism community’s public support given that IACC Federal members lack the will to pursue what is a basic science question. Both SafeMinds and Autism Speaks withdrew their public support of the plan in January due to the failure of the IACC to recognize their duty to include vaccine specific objectives in the IACC’s strategic plan. The next IACC meeting will held be May 4th.
On to Friday, February 6th, and the public meeting of the National Vaccine Advisory Committee (NVAC) with Stakeholders to discuss the 2008 Draft Strategic National Vaccine Plan. The purpose of this meeting was to gather stakeholder input on the updating the 1994 National Vaccine Plan. To view the draft plan, click here. The goals of this strategic plan are to:
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Develop new and improved vaccines;
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Enhance the safety of vaccines and vaccination practices;
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Support informed vaccine decision-making by the public, providers, and policy-makers;
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Ensure a stable supply of recommended vaccines and achieve better use of existing vaccines to prevent disease, disability and death in the United States; and
- Increase global prevention of death and disease through safe and effective vaccination.
The primary suggestion that should be made to the committee in taking these goals at face value would be to reverse the order of goals one and two, as safety should be the primary focus and can no longer be given short shrift. It is difficult to entertain the introduction of new and improved vaccines in the face of serious vaccine-safety research gaps. In listening to the afternoon session of vaccine manufacturers, it was their opinion that CDC was not spending enough on the promotion of vaccines because uptake did not meet their expectations and thus it was difficult to justify the development of new vaccines. On repeating Dr. Cooper’s statements from earlier in the week and asking their thoughts on what appeared to be a disconnect on CDC vaccine promotion funding, their response was that these concerns were an FDA post-licensure issue and that FDA also required more funding to do their job. Not necessarily a wrong answer, but it left the impression that industry really couldn’t be bothered these safety concerns and certainly didn’t want to address existing funding disparities between safety and promotion.
There are three opportunities for public participation regarding the draft of the National Vaccine Plan. Meetings will be held in St. Louis, MO on March 14, Columbus, OH on March 28, and Syracuse, NY on April 4. These meetings will include up to 100 community members from a variety of community networks, including health care providers, school-based and home-school-based organizations, alternative medicine providers, and the local media provide a broad cross-section of commentary and limited to residents. Participants must register in advance and details can be found here.
SafeMinds plans to have representation at many of these meetings, however, every voice counts in during public engagement. We ask our readers to participate and request that the agenda put safety first and recommend higher investments in unbiased vaccine-safety research and a comprehensive study of vaccinated and unvaccinated populations to determine total health outcomes.