Dr. Paul Offit, of CHOP, Merck RotaTeq Co-Inventor, and Amy Pisani of Industry Pharma "Advocacy" Group Every Child by Two
Every Child By Two (ECBT) lead the charge to derail the Congressional hearing into the National Vaccine Injury Compensation Program (NVICP). In her 11/12/13 letter to Chairman Darrell Issa and members of the Oversight and Government Reform (OGR) Committee, ECBT Director Amy Pisani, stated:
“I write to you on behalf of Every Child by Two to express our concern over an upcoming hearing on the National Vaccine Injury Compensation Program. We urge you to contact Chairman Issa to request that the hearing focus on potential remedies to the program and mechanisms already in place through the Advisory Commission on Childhood Vaccines.
Every Child By Two is greatly concerned that the hearing may steer toward a rehashing of the already disproven theory that vaccines are a cause of autism and other disorders…
Fortunately, when the program was created a mechanism for ongoing oversight was also instituted: the Advisory Commission on Childhood Vaccines (ACCV). This commission meets regularly each year to make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the NVICP. There are nine voting members (two of whom are parents of vaccine-injured children) who provide oversight of the NVICP and recommend ways to improve the program. Remedies to the program can and should be facilitated through the Advisory Commission on Childhood Vaccines (ACCV)…
I am happy to come to meet with you to discuss our concerns and represent the parents who have benefitted from vaccines by having healthy children and those who have lost their children to deadly diseases, both of whom are often underrepresented in these matters.”
Ms. Pisani urges Congress to allow the Advisory Commission on Childhood Vaccines (ACCV) Commission to work on reforms, rather than allowing Congress to question the actions of the ACCV. The ACCV was indeed established by Congress to advise the Secretary of HHS regarding operations of the NVICP and to provide public representation and public outreach regarding the program.
But in asking Congress to allow the NVICP to reform itself, it must be pointed out that the ACCV’s has never provided the oversight and reform. Those running the NVICP do what they want and the pharmaceutical industry – which also funds ECBT - provides cover. The few recommendations that the Commission has put before the Secretary of HHS have rarely been acted on. Public outreach efforts have been dismal at best.
Along with the rest of the utilitarian “vaccinate every person for the greater good” crowd, Amy Pisiani and ECBT is suppressing the right of citizens to address executive branch wrong-doing through their elected representatives.
One ACCV effort that needs to be scrutinized is the Banyan Communications contract awarded in 2010. Over $300,000.00 was paid to Banyan to develop and implement a public outreach program to educate the public about the NVICP. The outreach program was never implemented. Most Americans have no idea that the NVICP exists, suppressing the number of vaccine injury claims. Several FOIA requests have been submitted to HRSA regarding the Banyan contract and associated persons. Those requests have been ignored.
At the September 2008 quarterly meeting, Dr. Geoffrey Evans, Director of the DVIC and Executive Secretary of the ACCV, announced that the Institute of Medicine (IOM) was awarded a $ 1.7 million dollars to study adverse events of childhood vaccines (eventually published in 2011). At issue is where the money for the IOM study came from. The minutes of that ACCV meeting suggest that the money was appropriated from the Vaccine Trust Fund (VTF) thru HRSA to the IOM. The VTF was established to pay compensation awards to petitioners, their attorneys, and for the administration of the NVICP – not to pay for research.
Once again, a FOIA request to HRSA asking for who authorized the payment and where was the ultimate source of funds has been ignored.
One of the primary functions of the ACCV is to provide meaningful recommendations to the Secretary of HHS.
A review of all the proposed ACCV recommendations dating back to 1990 has revealed few successes. The ACCV has repeatedly recommended expansion of the three (3) year statute of limitations for vaccine injury (2 years for death cases) to six (6) years and on one occasion eight (8) years. The Secretary of HHS has disregarded these reform recommendations.
The current makeup of the ACCV is:
Nine voting member commission consisting of (1) Three health professionals, who are not employees of the United States Government, and who have expertise in the health care of children, and the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians; (2) three members from the general public, of whom at least two shall be legal representatives (parents or guardians) of children who have suffered a vaccine related injury or death; and (3) three attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death, and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers. In addition, the Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials) serve as nonvoting ex officio members.
One of the ACCV members – Dr. Kristen A. Feemster, M.D – works with Dr. Paul Offit in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia. Dr. Offit is an ECBT board member, essentially, one of Ms. Pisani’s bosses.
ACCV quarterly meetings are now held via conference call. This decision was announced at the December 2012 meeting by Dr. Vito Caserta, the new Acting Director of the Division of vaccine Injury Compensation (DVIC) and Executive Secretary of the ACCV. Caserta suspended in person meetings due to “budgetary concerns”. This is curious as the ACCV is funded by a direct appropriation of the Vaccine Injury Trust Fund and should not be subject to Congressional budget tensions.
There has been some discussion during last week’s meeting of conducting one or two future meetings in person.
As a result, the general public has even less access to the ACCV than it used to. One must be willing to spend the 6 to 8 hours on the phone before being allowed to comment at the designated time in the meeting agenda. There is no ability to submit comments before or after via email or letter for inclusion on the record. The public is not allowed to ask questions of the Commission – only to make statements.
At the Congressional Staff Briefing on November 4, 2013, Mary Holland and Rolf Hazelhurst spoke in great detail about why the NVICP is not working as Congress intended. Both highlighted the corruption, intimidation, deceit and manipulation by the NVICP. I suspect these concerns will not be addressed by the ACCV. That is why Congress needs to act.
However, in the hopes of stirring some Commission action, Louis Conte, read the statement below at the December 5, 2013 ACCV meeting.
Comments of Louis Conte to the Advisory Commission on Childhood Vaccines
Chairman King and ACCV Members, I disclose the following:
In a letter supporting the NVICP and opposing the Congressional Hearings that were to held on the program yesterday, Amy Pisani, the Director of Every Child By Two stated “Remedies to the current program can be facilitated through the Advisory Commission on Childhood Vaccines (ACCV).” With that in mind, I felt that I should bring my concerns about the NVICP to the attention of your honorable commission.
In the ECBT letter, we are advised that vaccines do not cause autism, that the science is in and that the Omnibus Autism Proceedings declared that vaccines do not cause autism. However, In Unanswered Questions, we found 83 cases of vaccine induced brain damage that featured autism. One case decision in particular clearly described vaccine injury leading to acute disseminated encephalomyelitis (ADEM) then to PDD-NOS (an autism spectrum disorder). Special Master Richard B. Abell was quite clear:
“The Court found, supra, that Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.”
I am concerned that the NVICP is not working the way Congress intended. People working in the program understood the reality of cases like the one above and many other cases quietly settled over the past 25 years. The decisions in the OAP did not address what this program has understood from the earliest days; in cases of acute encephalopathy, brain damage, a sequelae of that damage often includes autism. Based on the history of cases within the program, verified by Unanswered Questions, the statement “Vaccines don’t cause autism” is incomplete unless one adds “However, vaccines cause encephalopathy (not in dispute as it is on the NVICP Injury Table) and the behavioral disorder called ‘autism’ can be a result.” The cases from the program tell us this. A February 2009 email from HRSA’s David Bowman to journalist David Kirby informs tells us this as well:
“In response to your most recent inquiry, HRSA has the following statement: The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines. We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures. Some children who have been compensated for vaccine injuries may have shown signs of autism before the decision to compensate, or may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.”
I must assume that Mr. Bowman understood these facts from the case experience of the Division of Vaccine Injury. This reality has been re-affirmed in many cases; Child Doe 77 and most recently in Mojabi. Both cases are described as encephalopathy table injuries featuring autism.
Because Congress intended the NVICP to be fair and compassionate and to make vaccines safer, this knowledge ought to have been disclosed to program petitioners, to the public and to the scientific community so that meaningful research could be conducted into what gives rise to the behavioral diagnosis of autism in the presence of encephalopathy. Although this ought to have been declared years ago, the ACCV can ask the Secretary of Health and Human Services to now declare this reality, now.
I note that the Duties from the ACCV Charter are:
* Advise the Secretary on the implementation of the Program
* Advise the Secretary on changes to the Vaccine Injury Table
* Advise the Secretary regarding the need for childhood vaccination products that result in fewer significant adverse reactions
* Survey programs that gather vaccine adverse event information
* Advise the Secretary on the means to obtain, compile, publish and use credible data related to the frequency and severity of childhood vaccine adverse reactions
* Recommend vaccine injury research to the National Vaccine Program Office Director
* Consult on the development and revision of the Vaccine Information Statements
Consistent with the ACCV’s obligation to advise the Secretary on the implementation of the Program, it is now time for the ACCV to inform the Secretary of Health and Human Services that vaccine injuries that result in acute encephalopathy can result in autism or autistic symptoms, just as Mr. Bowman stated in 2009. The ACCV should advise the Secretary to modify the vaccine injury table definition of encephalopathy to reflect this reality and to revise Vaccine Information Statements to reflect this, as well.
The NVICP and its’ trust fund is supported by tax payers. The NVICP belongs to the people and so does the information it possesses. I urge this honorable commission to consider my recommendations.
Wayne Rohde, Father to Nick Rohde, 16, diagnosed with moderate-severe autism. Author of upcoming book, The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program – SkyHorse Publishing
Posted by Age of Autism at December 12, 2013 at 5:45 AM