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SafeMinds flu vaccine information hits theater's nationwide in November
Thanks to the generous donation of SafeMinds and Age of Autism constituents we will be showing the SafeMinds 30-second public service announcement in theatres across the country during Thanksgiving, the biggest movie attendance week of the year. Tomorrow at noon MST is our deadline for ordering ads at new theaters. There is still time to contribute!

This is how much it costs to run at movie theatres in some of the major markets at every movie screening, in select theaters, for one week at Thanksgiving:
- 25 screens in New York for $1,560
- 25 screens in Los Angeles for $1,560
- 19 screens in Boston for $1,000
- 16 screens in Atlanta for $850
Help us make it happen!
Theaters require a one week minimum showing, therefore donations may be pool or shifted to other cities. |
Message from the Executive Director
The Advisory Committee for Immunization Practices, which makes recommendations for U.S vaccine policy, met October 27th in Atlanta at the Centers for Disease Control and Prevention. The committee discussed implementing the use of evidence-based guidelines for development of vaccine recommendations. Over the past few years, several professional associations have encouraged the ACIP to adopt the GRADE system for determining vaccine policy and recommendations. The impetus for such discussion was based on the fact that several medical societies, including the American College of Physicians which is the largest medical specialty organization, have voiced concerns about adopting ACIP's vaccination recommendations since they were not based on evidence.
SafeMinds spoke during the public comment period supporting the adoption of a standardized, transparent and systematic approach to assessing future and past ACIP policies on vaccinations. We specifically asked that these components be incorporated into any ACIP evidence appraisal process.
- That the appraisal be conducted by an independent entity without financial or career investment in vaccine programs.
- That the appraisal include all clinical research on vaccines, including phase 1, 2 and 3 trials as well as post-licensure studies, and that results on adverse effects be combined across all such trials in order to more accurately characterize relatively rare events that may not be identifiable or significant in a single trial.
- That the number needed to treat be comprised of both number needed to benefit and number needed to harm calculations.
- That a grey literature search be conducted to capture all potential studies and reduce publication bias.
- That a risk of bias evaluation be included for any study and a summary included in the review.
- That appraisals use independent systematic reviews when available.
- That patient-important and real world effectiveness outcomes are used.
- That the appraisal be conducted retroactively for current vaccines and not just for future vaccines.
- That the review be published with all supporting evidence, as is done in a Cochrane systematic review to ensure transparency, and that the public and scientific community be allowed to comment on the appraisal prior to consideration by the ACIP.
- That knowledgeable consumer advocates be included in the process, including patient safety advocates, to better address the needs of patients.
SafeMinds further asked that guidelines developed from the appraisal include a comparative effectiveness of approaches other than vaccines in preventing the mortality and morbidity of the targeted disease, and that cost/benefit comparisons be an important factor. Money for vaccine programs reduces funding for other critical treatments.
Finally, we asked that the ACIP more widely use guidelines calling for "optional use" rather than universal recommendation, in order to better allow clinical judgment and patient values to be incorporated into vaccination decision-making in the clinical setting.
Ultimately, the committee voted to adopt a process that acknowledges the type of information that they relied on, which is not adequate or as scientifically stringent an evidence analysis as GRADE. Safeminds plans to continue to voice concerns regarding the absence of evidence-based guidelines. The American public deserves vaccine decisions that are transparent and based on science verses opinion.
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Rally to Restore Sanity and/or Fear By SafeMinds Board Member Gayle DeLong

I recently attended the "Rally to Restore Sanity and/or Fear" sponsored by Comedy Central's Jon Stewart and Stephen Colbert.
I was blown away by the positive response I received about my sign: "Restore Sanity to the Vaccination Schedule." Mothers with infants said they were aware of the issue and they were being cautious about the shots given to their children. A grandmother asked me what I would do differently. I even spoke with someone in the Inspector General's office of HHS. When I pointed out that children were getting too many shots, his wife chimed in that her grandmother had mumps and had to sit in a darkened room for a week. I should have echoed Katie Wright and replied: I wish the only thing my kids had to do was sit in a darkened room for a week to recover.
The point is, our message is getting out. People are asking questions about vaccine safety. They are not allowing fear to take over their lives and the lives of their children. Jon Stewart promoted sanity at the rally, while Stephen Colbert promoted fear. In the end, Colbert melted like the Wicked Witch of the West saying "Your reasonableness is poisoning my fear." Reasonableness in any situation is greater than fear.
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SafeMinds Recommends - All I Can Handle by Kim Stagliano

"Incredibly funny. . . A bird's-eye view into what it's really like to love and raise kids with autism." -Jenny McCarthy, from her foreword
ALL I CAN HANDLE: I'm No Mother Teresa (A Life Raising Three Daughters with Autism) By Kim Stagliano
How one woman raises three autistic daughters, loses one at Disneyworld, stays married, Has sex, bakes gluten-free, goes broke, and keeps her sense of humor. Click here to buy now. |
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New study looks at Hepatitis B vaccine and autism
A new publication by Carolyn Gallagher and Melody Goodman looks at rates of autism associated with Hepatitis B vaccination in neonates. The study used information from the National Health Interview Survey to assess relative risk of autism in 3-17 year-old boys born from 1997-2002. In the subgroup of boys born before 1999 (with a vaccination record), the risk of autism was 3-fold greater in boys who received Hepatitis B vaccine during the first month of life compared to boys who were vaccinated later or not at all. These results were adjusted for race, family structure, and maternal education. To read the full study, click here.
Editor's Note: The recommendation to remove thimerosal from childhood vaccines, including Hepatitis B vaccines, was made in 1999.
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An afternoon with the Special Masters and the October ACCV Meeting
By Becky Estepp
On October 26, 2010, the Court of Federal Claims hosted a three-hour meeting with the Special Masters who presided over the tests cases for the Omnibus Autism Program (OAP). All three Special Masters gave a brief update of the OAP and then entertained questions from the audience, which was largely made up of attorneys who practice in vaccine court.
Special Master Hastings started off by declaring that the program is not over even though the first six test cases lost. There are still other theories of causation that will be entertained by the court. Mitochondrial dysfunction is one theory that is currently being examined. He then gave the following statistics:
· 4726 claims are still pending in the OAP · 400 of those claims are pro se (parent represented/no attorney representation) · 4300 claims are represented by attorneys · 2600 claims are represented by six firms that each have several hundred cases · 140 attorneys in the program have only 1-10 cases each
Special Master Hastings recognized that many of the petitioners in the OAP do not feel they will be successful in this court. Due to this bleak sentiment, many parents have decided to leave the program on their own. Read more.
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The Supreme Court hears arguments on autism
By SafeMinds Government Affairs Committee Member Mary Holland, Esq.
On October 12, eight Justices of the U.S. Supreme Court heard Bruesewitz v. Wyeth. The case is potentially significant because it may decide whether families, like the Bruesewitz family, have the right to sue for vaccine design defect claims in regular courts.
Since Congress passed the 1986 National Childhood Vaccine Injury Act, a person injured by a federally recommended vaccine must sue for injury first in the Vaccine Injury Compensation Program (VICP) of the Court of Federal Claims. The injured person may not simply go to state or federal court and sue the manufacturer or doctor directly. The 1986 Law clearly left open, though, the right to sue manufacturers in civil court, after first filing in the VICP, if the vaccine was improperly manufactured or improperly labeled. The Law does not state clearly, though, whether the injured party may sue for design defect claims in civil court. The issue before the Supreme Court is, do families have this right or is this right "preempted" or precluded by the 1986 Law?
The claim the Bruesewitz family wants to bring in civil court is that the diphtheria-pertussis-tetanus (DPT) vaccine that their daughter Hannah received was unreasonably dangerous, because the manufacturer had safer, commercially viable, equally effective vaccine designs available to it. The parties are litigating over rival interpretations of the phrase in Section 22(b)(1) of the 1986 Law that precludes liability for claims against vaccine manufacturers "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
The Coalition for Safe Minds, together with 24 other civil society organizations and 3 individuals engaged in negotiating the1986 Law on behalf of vaccine-injured families, filed a friend-of-the-court brief on behalf of Hannah Bruesewitz, arguing that the Law does allow families to sue in civil court for vaccine design defect.[1] Indeed, the brief argues that families of vaccine-injured children would not have otherwise supported the 1986 Law. The brief also argues that the VICP is not functioning as Congress intended, so recourse to civil courts is more important than ever.
Justice Kagan did not participate because she had been Solicitor General for the Department of Justice before becoming a Justice and had sided in that capacity with Wyeth. Justice Roberts "unrecused" himself shortly before oral argument by selling his Pfizer stock (which recently acquired Wyeth) so that he could participate in the decision.
It is unwise to speculate on how the Justices will decide. One thing was clear, though - the Justices held a wide range of views. Justices Scalia, Alito and Roberts seemed very skeptical that Congress could have wanted laypeople on juries to make decisions about vaccine design defects. Justices Sotomayor and Ginsburg seemed very skeptical that Congress could have meant to preclude the right to sue without having said so more clearly. Justices Breyer and Kennedy seemed undecided, finding the text quite opaque and asking tough questions of both sides. Justice Thomas asked no questions, so it was difficult to gauge what was going on in his mind.
This is not the only preemption case on the Supreme Court's docket this year. There are several other cases as well that pose the interests of consumers against the interests of big business and asks the question, which law applies? state or federal?
It is likely that that Supreme Court will decide this case in 2011. For SafeMinds and other organizations interested in judicial review of the use of mercury as a vaccine preservative, this case could be pivotal. If the Bruesewitz family wins, those claims will likely be able to go forward in civil court. If Wyeth wins, those claims will face a stiff uphill climb. If the Court is deadlocked 4-4, which is possible, the decision of the lower court, the Third Circuit Court of Appeals, would stand between the parties; that decision was in Wyeth's favor. A 4-4 decision, however, would essentially leave the issue unresolved around the country. In some places, like the state of Georgia, one would be able to sue for design defect. In other places, like Pennsylvania, one would not be able to sue for design defect. In some ways, a 4-4 outcome would be worst of all because it would leave the issue undecided. Stay tuned for a decision in 2011.
[1] All briefs in the case, including the one signed by the Coalition for SafeMinds, are available at http://www.abanet.org/publiced/preview/briefs/oct2010.shtml. An audio transcript and written transcript of oral argument is available at http://www.supremecourt.gov/oral_arguments/argument_audio_detail.aspx?argument=09-152.
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Combating Autism Act Reauthorization Coalition
SafeMinds would like to announce the formation of the Combating Autism Act Reauthorization Coalition (CAARC). As members, we encourage both individuals and organizations to join us in support of our guiding principles.
Together, we can design and reauthorize the best possible federal legislation that provides critically needed direct services along with usable research that can address both the immediate needs of individuals with autism and their families, and help prevent new families from facing the costs, health burdens and lost opportunities that come with an autism diagnosis. We invite you to join us in this opportunity to meet the needs of Americans with autism.
We are advocating for legislation that will:
- Recognize that our country faces a national public health emergency.
- Direct increased resources for a lifespan of autism services through established services infrastructure at the state level.
- Dedicate federal research to strategic research that can halt the autism epidemic in its tracks.
- Conduct autism surveillance with the scope, timeliness and rigor appropriate to the need.
- Focus strategic new research in areas that can yield meaningful near term results.
- Keep individuals with autism safe from accidental death and injury.
- Prevent harmful restraint and seclusion of autistic individuals.
- Address critical gaps in vaccine safety research and policy governance.
- End health insurance discrimination against individuals with autism.
- Develop autism policy with an open, transparent approach.
We can make a difference if we unite our voices. Please visit their website at http://caacoalition.org/.
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