Vaccine Science: A Search for Truth

by Barbara Loe Fisher

February 2009 turned out to be a month when vaccine science was put on trial in the U.S. Court of Claims in Washington, D.C., in mainstream media and on the internet, in the British Medical Journal and in vaccine safety research initiatives by the U.S. Department of Health and Human Services. Despite concerted efforts by some to close the book on vaccine-related brain dysfunction that includes autism spectrum disorders, it is clear that the search for scientific truth will continue as it always must in science.

The month began with a Feb. 6 CBS-TV news report on new information released by NVIC on serious Gardasil risks, which was followed within 48 hours by a highly orchestrated and very well publicized transatlantic attack on MMR vaccine researcher Andrew Wakefield, M.D. in preparation for a Feb. 12 public announcement by the U.S. Court of Claims denying federal compensation to three children, who regressed into autism after MMR vaccination. The same day that three autistic children were denied federal compensation in the U.S., the British Medical Journal published a Cochrane Collaboration analysis revealing that influenza vaccine studies are more likely to be published in medical journals and rated highly if they are funded by pharmaceutical companies, even when the vaccine studies are of poor quality.

The month ended on a hopeful note with a joint statement finalized February 27 by a CDC- sponsored vaccine safety writing workgroup that asked the National Vaccine Advisory Committee (NVAC) to consider conducting more research into the vaccine schedule, whether some children are biologically at greater risk than others for suffering vaccine reactions and whether there are differences in immune and brain function between vaccinated vs. unvaccinated children. The proposal to investigate adding these kinds of studies to the national vaccie safety research agenda, if approved by the entire NVAC, would include identification of biological markers and biological differences, if any, in brain and immune system function between vaccinated and unvaccinated children.

In a questionable "class action" type Omnibus hearing process, whereby the U.S. Department of Justice allowed (encouraged?) some 5,000 cases of regressive autism after vaccination to be lumped together and argued by plaintiff's lawyers using two narrow biological mechanism hypotheses involving thimerosal and MMR vaccine, the first three Omnibus cases were rejected by three special masters employed by the U.S. Court of Claims. The Court relied heavily on epidemiological studies published in medical journals - the same medical journals which give preferential treatment to methodologically flawed studies funded by vaccine manufacturers.

In a distortion of the National Childhood Vaccine Injury Act that created the Vaccine Injury Compensation Program (VICP), the Court appears to have inappropriately assumed authority that Congress never gave them in 1986: to act as judge and jury on a global scientific question yet to be definitively answered by medical science. The special masters of the Court are neither qualified nor was the 1986 law intended to give them the power to determine the scientific validity of whether vaccines can ever cause autism or any other permanent injury. The special masters were supposed to be administrators and facilitators for providing no-fault, non adversarial federal vaccine injury compensation in lieu of a civil lawsuit against vaccine manufacturers and physicians. In fulfilling that responsibility, these administrators for the Court were supposed to "presume" causation in the absence of a more biologically plausible explanation for the child's injuries or death.

The tragic consequence of this and other politically motivated distortions of the 1986 law is that thousands of previously healthy children, who suffered brain injury and regressed into autism after vaccination, are now in danger of having their vaccine injury claims prejudicially judged and dismissed without being given their own day in "vaccine court." Most of these children certainly will never have their day in civil court in front of a jury of their peers.

Vaccine injury cases are each different due to biodiversity, individual extenuating circumstances, vaccines or combination of vaccines given, plus a number of biological mechanisms for vaccine injury and death - known and unknown - that can be argued in an individual case. This means that an individualized, not a group, approach to obtaining and awarding federal vaccine injury compensation is required. A case in point is the Feb. 20 release of a U.S. Court of Claims compensation award to a child who suffered brain inflammation (Acute Disseminated Encephalomyelitis) after MMR vaccination and was left with permanent brain dysfunction, including autism.

There have been other awards in the VICP for cases of DPT and DTaP vaccine induced brain inflammation/encephalopathy that caused permanent brain injury, including autism. A long acknowledged serious complication of both infectious disease and vaccination is acute brain inflammation that can cause chronic brain dysfunction manifested in many different ways. (See Vaccines, Autism & Chronic Inflammation: The New Epidemic)

So, despite the concerted efforts by some to misrepresent the legal and political significance of recent U.S. Court of Claims judgments in order to dismiss vaccine associated autism as having no scientific validity, vaccine safety advocates have pledged to continue calls for credible scientific investigation into vaccine related neuroimmune dysfunction. Andrew Wakefield is demonstrating the same resolve by taking action to clear his name from libelous and slanderous charges by an obsessed British newspaper reporter who is behaving more like a jilted suitor-turned stalker than a credible journalist. Needless to say, Dr. Wakefield and others will continue scientific research into vaccine associated brain and immune system dysfunction in a dedicated effort to add to the base of scientific knowledge about vaccination.

Finally, it is a hopeful sign that at the end of February a joint statement was signed by a diverse group of vaccine stakeholders who met in Salt Lake City Feb. 20-21, 2009 to discuss national vaccine safety research priorities. Assisted by expert facilitators from The Keystone Center, the CDC sponsored Vaccine Safety Writing Group included federal and state public health officials, pediatricians, infectious disease specialists, immunologists, vaccine developers, health policy analysts, child vaccine advocates and representatives from vaccine safety and autism groups including NVIC, SafeMinds and Autism Speaks.

The vaccine stakeholder group stated that the National Vaccine Advisory Committee (NVAC) should "charge an expert panel with evaluating study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. This draft charge is responsive to issues raised at community meetings in Alabama, Oregon and Indiana as well as the Interagency Autism Coordinating Committee request for collaboration with the National Vaccine Program Office."

The group further stated that :

"There is a strong desire to study the health impact of the immunization schedule, potentially through a 'vaccinated vs. unvaccinated study.' Outcomes to assess include biomarkers of immunity and metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities. The inclusion of autism as an outcome is desired."

The meeting of vaccine stakeholders was the latest in a series of government/citizen encounters that began in 2002 in a CDC-sponsored participatory democracy initiative called the Vaccine Policy Analysis Collaborative. Although the original vaccine stakeholder group dissolved in 2005, the CDC's effort to engage the public was revitalized in mid-2008 and after the election of President Obama, who is an advocate of the public engagement process to create mechanisms for meaningful dialogue that will result in well informed and wise government policy.

There is reason to celebrate whenever government officials and vaccine stakeholders support more research into the biological mechanisms and biomarkers for vaccine injury and death. That being said, I have learned first hand that change in government policy can be painfully slow. And so, when another mother calls to tell me that her daughter has died after Gardasil vaccine or is lying crippled in bed unable to walk, my celebration of this vaccine stakeholder recommendation is tempered by the tears I shed with mothers, whose children are being injured by government recommended vaccines today.

Still, it is a hopeful sign that health officials in the new Administration are listening to the legitimate calls for more and better vaccine safety science and will work more effectively with citizens to prevent vaccine injuries and deaths now and in the future. As was discussed in Salt Lake City, the participatory democracy model with regard to government- sponsored research into vaccine-related immune and brain dysfunction, should include transparency and public participation in the design and oversight on conducting of that research.

On March 16, 2009 from 9 to 5 p.m. at the Hubert Humphrey Building, 200 Independence Ave. SW, Washington, D.C., the National Vaccine Advisory Committee will hold an open public meeting for citizens to discuss the government's draft vaccine safety research agenda.
To register to attend, contact Kirsten Vannice at: Kirsten.vannice@hhs.gov. To join the meeting via telephone or by webscast, go to http://www.hhs.gov/nvpo/nvac/PublicEngageme nt.html