The Washington Post TV Dialogue on "Vaccines: Science vs. Skeptics"

Posted: 8/21/2013 11:02:26 AM | with 14 comments
On Aug. 20, 2013 NVIC Executive Director Theresa Wrangham participated in a Skype interview on the new Post-TV "On Background" show along with Dr. Corey Hebert of Louisiana State University Health Sciences Center. The  Washington Post-sponsored TV segment titled "Vaccines: Science vs. Skeptics" was moderated by Nia-Malika Henderson. Theresa defended parents' right to make informed vaccine choices. She emphasized there are both vaccine science research gaps and individual susceptibility to vaccine reactions, as well as an association between vaccine-induced encephalopathy and poor health outcomes like autism, which have been acknowledged in the federal vaccine injury compensation program.  



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NVIC.org - The Story Behind MedAlerts

Posted: 8/20/2013 10:05:05 PM | with 1 comments
  By Patrice La Vigne 
 
Steven RubinMedAlerts is the unique database search engine created and launched online in 2003 by computer science expert Steven Rubin, PhD.,1 to allow people to search and review reports of vaccine-related complications made to the federal Vaccine Adverse Events Reporting System (VAERS).  Dr. Rubin developed MedAlerts to provide people with a user-friendly way to search vaccine reactions reported to the U.S. government by doctors, nurses and other vaccine providers, as well as the public.
 
VAERS was included as part of the vaccine safety informing, recording and reporting provisions that NVIC co-founders secured in the 1986 National Childhood Vaccine Injury Act as an integrated post-marketing surveillance system to monitor potential safety problems with vaccines.2 VAERS is jointly operated by the Food and Drug Administration (FDA) and Centers for Disease Control (CDC).3
 
With 60,000 hits daily, Dr. Rubin estimates MedAlerts attracts some 3,000 unique visitors to the website per day. Following is an historical look-back at why and how Dr. Rubin created the invaluable online VAERS database search engine, MedAlerts, that can be accessed through NVIC.org.   
 
Parents’ Experiences with Vaccine Reactions Leads to Computer Program
 
Steven Rubin never planned to create MedAlerts or get involved with vaccine reaction reporting. The VAERS data wasn’t even on his radar. In the 1990’s, he was simply working as a computer scientist writing open-source software. In 1996, his wife, Amy Lansky, PhD, left her job as a computer scientist to study homeopathy and later wrote the book, “Impossible Cure,” about their son’s autism and the important role homeopathic remedies played in their son’s recovery from autism.4
 
In the late 1990’s, Dr. Rubin became aware that babies were dying and suffering brain injury after routine vaccinations and he began investigating the federal VAERS data. At that time, he observed “VAERS was available to the public only as a collection of terse and unusable data files.” After spending a few days analyzing the VAERS data files, he developed a new computer software program to analyze and make sense of the VAERS data files.   
 
Before MedAlerts: NVIC Monitors VAERS DPT “Hot Lots”
 
Before Dr. Rubin created MedAlerts, for more than a decade after Congress passed the 1986 National Childhood Vaccine Injury Act, NVIC co-founders had routinely submitted Freedom of Information Act (FOIA) requests to the CDC to obtain computer discs with raw data from VAERS. The process often took three to four months to complete from time of NVIC’s FOIA submission to receipt of the discs.
 
With the help of a computer programmer, who developed special software to de-code the raw data, between 1990 and 2000 NVIC co-founder and vice president Kathi Williams monitored reports of infant deaths and symptoms of brain inflammation/encephalopathy that were associated with different lots of DPT vaccine and NVIC published lists of “hot lots” of DPT vaccine.
 
In 1994, NBC broadcast a special investigative report on the “NBC Now Show Tom Brokaw and Katie Couric” that featured a family, whose son was severely brain injured by DPT vaccine that came from a DPT “Hot Lot.”5
 
Making the VAERS Data Easy to Search
 
Once Dr. Rubin developed easy-to-use software to search the VAERS database, he was astonished by all of the information contained in VAERS. He decided that the public should have access to a website that features government vaccine reaction report data and converts it into a format so anyone can search it.
 
After the launch of the website in 2003, more and more people discovered MedAlerts. As its popularity grew, Dr. Rubin looked for an established vaccine education group to partner with and his wife suggested the National Vaccine Information Center.
 
MedAlerts & NVIC.org: A Match
 
When Dr. Rubin approached NVIC in 2005, the reputation of the MedAlerts database was already known to NVIC’s co-founders.
 
“We were very excited to partner with Dr. Rubin and connect MedAlerts with NVIC.org,” said Kathi Williams. “We knew the public would like being able to easily search the VAERS database online through NVIC’s website, which is the oldest consumer-operated vaccine information website on the Internet.”
 
The MedAlerts website was visually rebranded to align with NVIC.org and, in 2009, Dr. Rubin became NVIC’s volunteer Director of Vaccine Research Analytics.
 
Analyzing Emerging Trends in VAERS Reports
 
Dr. Rubin not only programs, continually updates and acts as the system administrator for MedAlerts, he takes the VAERS data one step further by analyzing emerging trends and posting The MedAlerts Blogdescribing those trends.6  For example, one trend he has reported this year is that for the past two years, there have been fewer VAERS reports filed.
 
The potential reasons for a decline in vaccine adverse event reports made to VAERS could be varied, from doctors preferring to make vaccine reaction reports to vaccine manufacturers instead of the federal government or to a growing lack of interest in completing the required paperwork (even though the requirement to report is part of federal law).  
 
Dr. Rubin sometimes is asked to answer specific “cause and effect” questions about individual VAERS reports or trends he observes but urges people to remember that he is a computer scientist analyzing data and not a medical professional giving medical advice!7
 
MedAlerts – Better than the CDC’s Wonder Database
 
MedAlerts was the first online search engine that gave the public an easy-to-use tool to review and analyze VAERS data. Shortly after MedAlerts was posted online, the federal government created the CDC-operated Wonder (Wide-ranging Online Data for Epidemiologic Research). Dr. Rubin maintains that MedAlerts has a better user interface with increased search capabilities and more powerful reporting capabilities than CDC Wonder.
 
“Over the years, I’ve seen things that I have in MedAlerts get adopted by CDC Wonder,” he said. “To me, this is great news … it show that my efforts are pushing the government to keep up.”
 
Further, MedAlerts seems to be the popular choice for families as well as health professionals examining the VAERS database. Dr. Rubin recalled that “Dr. Vicky Debold (NVIC’s volunteer Director of Research and Patient Safety) once went to a government briefing on vaccine safety. She noticed that the government scientist had slides that obviously came from MedAlerts (not CDC Wonder). When she asked the scientist why, he told her that organizations questioning vaccine safety have “the best VAERS search engine.’”
 
Building the Unique “Wayback Machine” To Double-Check VAERS
 
On MedAlerts, you can search adverse events by vaccine, symptoms of reactions, dates, state of residence, age and more. In August 2012, Dr. Rubin  added a feature that allows people to analyze VAERS information dating back to 2003.8
 
“As a ‘digital packrat,’ I never throw away a disk file. As a result, I realized that I had every government download since 2003, sitting on my computer,” he said. He was spurred to build the “Wayback Machine,” allowing MedAlerts users “to compare any two government data releases, look at the history of changes to any VAERS report, and do other high-level analysis.
 
NVIC uses the “Wayback” feature to check monthly releases of government data. “Suspicious changes to the VAERS data are easily spotted,” said Dr. Rubin.
 
MedAlerts: The “Go To” Vaccine Reaction Search Engine
 
Doctors, nurses and other vaccine providers are not the only ones who can report to VAERS. Anyone receiving a vaccine or who is the parent of a child, who has suffered serious health problems following vaccination, can make a vaccine reaction report to VAERS. If your doctor recommends that you or your child get one or more vaccines and you would like to check out publicly reported serious health problems associated with those vaccines, MedAlerts is a good place to start. Dr. Rubin has even created an online help for using it.
 
“MedAlerts is the go-to site for vaccine injury report information collected by the government,” Dr. Rubin said. “You can learn a lot by reading the signs and symptoms of vaccine reactions that are being reported and recorded in this important database.”

 
References:

3  U.S. Department of Health & Human Services. Vaccine Adverse Events Reporting System (VAERS).
 
4  Lansky AL. Impossible Cure: The Promise of HomeopathyR.L. Ranch Press 2003.
 
5  NBC-TV.  “What You Should Know Before Your Children Get Their Shots.” NBC Now Show with Tom Brokaw and Katie Couric Mar. 2, 1994.
 
6  Rubin S. MedAlerts Blog. April 2013: Symptoms of Flu and HPV. The MedAlerts Blog April 2013.
 
7 Rubin S. January, 2013: Yearly wrapupThe MedAlerts Blog January 2013.
 
8 Wrangham T. MedAlerts Adds “Wayback” Feature For Vaccine Reaction SearchesNVIC Newsletter. Aug. 21, 2012. 
 

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ICPA Offers NVIC Supporters Special Subscription to Pathways to Family Wellness

Posted: 8/15/2013 1:32:12 PM | with 4 comments
The International Chiropractic Pediatric Association (ICPA), which was founded by Dr. Larry Webster and represents doctors of chiropractic caring for children, has supported NVIC’s mission to prevent vaccine injuries and deaths through public education and to protect informed consent rights for more than two decades. ICPA’s 2013 issue of Pathways to Family Wellness magazine features an article written by Barbara Loe Fisher on “The Moral Right to Religious and Conscientious Belief Exemptions to Vaccination.” 
 
Pathways to Family Wellness is a full-color, quarterly publication that offers parents timely, relevant information about health and wellness options that will help them make conscious health choices for their families. ICPA offers NVIC donor supporters and NVIC Newsletter subscribers a complimentary digital version or print version of Pathways to Family Wellness magazine at a significant discount. Visit the Pathways subscription page and, when checking out in the shopping cart, add the exclusive code: NVIC. 
 
ICPA also has initiated parenting support groups that meet monthly to discuss health and parenting topics.  Meetings are hosted by local doctors of chiropractic and the Pathways website features a directory of local groups. ICPA Executive Director Dr. Jeanne Ohm said “We look forward to many more years of collaborating with NVIC to forward our shared goal of enhancing and protecting the ability of parents to make fully informed health and wellness choices for their children.”
 
 
 
 

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CDC Launches Media Campaigns to Increase Vaccine Use

Posted: 8/5/2013 9:51:31 PM | with 11 comments
Federal Vaccine Advisory Committee Update
By Theresa Wrangham, NVIC Executive Director

NVIC regularly monitors and reports on activities of federal vaccine advisory committee meetings held by the Centers for Disease Control (CDC) and Food and Drug Administration (FDA). These federal committees include the CDC’s National Vaccine Advisory Committee (NVAC), Advisory Commission on Childhood Vaccines (ACCV), Advisory Committee on Immunization Practices (ACIP) and the FDA’s Vaccines & Related Biological Products Advisory Committee (VRBPAC). NVIC representatives have served as consumer members of several of these committees during the past three decades and NVIC provides oral or written public comment on issues related to federal vaccine research, development, regulation and policymaking, frequently advocating for the inclusion of strong vaccine safety and informed consent protections in government vaccine policies. Vaccine advisory committee meetings are open to the public and committee meeting schedule links are posted on NVIC.org and in the NVIC Newsletter.
 
CDC Upset About Low HPV Vaccine Uptake
 
During NVAC and ACIP committee meetings held in 2013, CDC officials complained about missed opportunities1 and lack luster uptake of the HPV vaccine across the nation.2 In 2008, the NVAC supported HPV vaccine mandates that included doctors being allowed to give adolescents HPV vaccinations without the knowledge or consent of their parents. The current NVAC HPV Working Group continues to support this policy.
 
Both the NVAC and ACIP want increased use of the HPV vaccine by children (boys as well as girls) with NVAC’s HPV working group3 being charged with assisting the government in creating strategies to increase uptake of Merck’s Gardasil and GSK’s Cervarix vaccines. Recommendations from the working group included reframing the vaccine from an STD prevention vaccine to an “anti-cancer” vaccine in a new national media campaign.
 
The advertising campaign will attempt to brand HPV vaccine as a public health concern in an effort to end parental opposition to this vaccine. In addition, the CDC and medical trade groups will continue to urge pediatricians to offer HPV shots to all pre-adolescents and teenagers at the same time doctors give other government-recommended vaccines to them. They are also heavily promoting alternative settings for giving vaccines, such as schools and pharmacies.
 
HPV-associated cervical cancer is estimated to affect between 11,000 and 13,000 women annually in the U.S. with about 4,000 dying from cervical cancer, usually after many years of undetected and untreated chronic HPV infection. HPV is naturally cleared from the body within two years by more than 90 percent of those who become infected. Routine pap screening for women and early interventions to prevent cervical cancer has reduced cervical cancers in the U.S. by over 70 percent since the 1960’s.4
 
The CDC’s report to Congress in 2004,5 clearly stated that the majority of HPV infections “cause no clinical problems and go away on their own without treatment”. This same report touted the effectiveness of pap screening in decreasing the incidence and mortality of cervical cancer, while contributing to a 90 percent cervical cancer survival rate. The HPV vaccine three-shot series currently costs a minimum of $390,6 while a pap test can cost as little as $33.
 
This most recent repackaging and aggressive advertising of HPV vaccine by federal health officials raises the question: Is this a wise use of tax dollars in a health care system struggling to stay solvent?
 
Adults in the Crosshairs To Become Vaccine Compliant
 
Federal agency efforts to target adults and persuade them to toe the government vaccine policy line are underway. The take away from discussions by federal officials and committee members is that adults are non-compliant with government vaccine recommendations and fall far behind the aspirational federal Healthy People 20207 goals set for adult vaccine use. NVAC issued its recommendations8 in 2011 on strategies to increase adult vaccination and this topic is receiving more attention during committee meetings with yet another media and marketing/communications effort9 underway to target adults.
 
Current NVAC recommendations look to school entry mandates as a possible model to increase adult vaccine use in partnership with medical trade and other non-government organizations (NGO’s).  Should these recommendations pick up steam, they could result in employer-based mandates similar to those already being put into place for health care workers in hospitals and other medical facilities. Already, many workers in health care fields are being forced to receive annual flu shots and other government recommended vaccines as a condition of employment in compliance with Healthy People 2020 goals.
 
Vaccines for Pregnant Women: What About Injury Compensation?
 
During recent ACCV meetings, questions about the federal Vaccine Injury Compensation Program (VICP) have focused on vaccination recommendations for pregnant women. The CDC already recommends influenza and Tdap vaccinations for pregnant women, which have FDA category B or C designations, and there are new vaccines for respiratory syncytial virus (RSV) and Group B Streptococcus being developed for pregnant women.
 
Current and anticipated future vaccine use policies for pregnant women have turned up the heat on the ACCV to make recommendations about how vaccine injuries sustained during pregnancy will be compensated under the National Childhood Vaccine Injury Act of 1986. At a June ACCV meeting, members approved recommendations made by the ACCV Maternal Working Group that are being sent on to Secretary Sebelius for consideration to address vaccine injuries that occur during pregnancy. 
  • Expansion of the VICP to include vaccines that are routinely recommended pregnant women and not children;
  • Compensation of live born children sustaining a vaccine injury from a vaccine received while in utero;
  • Consideration of what legal steps to are necessary to accomplish the above, which include supporting a statutory amendment, administrative rulemaking or litigation strategy;
New Bird Flu Vaccine Being Developed
 
The CDC updated the ACIP and NVAC10 regarding the H7N9 outbreak in China and reported that, as of June 20, the majority of the 132 lab confirmed cases were in older men with underlying health conditions. The U.S. continues its ongoing surveillance of U.S. birds and testing of suspect human cases. The CDC reports that the H7N9 bird flu outbreak is currently limited to China,11 with all U.S. test case results returned as negative.12
 
Investigation by Chinese health officials of the outbreak has revealed that there is no evidence to support sustained human-to-human transmission of the H7N9 bird virus.13 Individuals at highest risk for infection are likely to be those in frequent contact with chickens, ducks and pigeons, such as working in the live bird farming industry.  
 
Despite evidence that H7N9 bird flu virus is not easily transmitted to humans, vaccines are being developed14 and evaluated for stockpiling to prepare for a potential future pandemic.
 
FDA Committee Selects Influenza Strains for 2013/2014 Flu Shots
 
On Feb. 27, 2013, the FDA’s Vaccines & Related Biological Products Advisory Committee (VRBPAC) met to select influenza strains to be included in the 2013/2014 flu shot. Vicky Debold, PhD, RN, who is NVIC’s volunteer Director of Research & Patient Safety, served as the consumer member on VRBPAC between 2008 and 2012 and was appointed a temporary voting member for this meeting.
 
During committee discussions, Dr. Debold expressed concern about lack of enough information about the safety of new quadrivalent flu vaccines that will be produced using dog kidney cells (Flucelvax) and army worm cells (Flublok) for the first time. She pointed out that there is a:  “need for information that helps us to understand which strains are most likely to be effective to have a successful vaccine, We need more information about predictive validity. This I think is even more salient this year than in any other year I’ve ever seen because we’re playing around now with trivalent and quadrivalent vaccines, we’re playing around with the different doses of antigen, we’re playing around with different platforms. We’ve got eggs, dog kidney cells, baculovirus army worm cells. There are a number of variables that are going on. Some of these vaccines can be given to some age groups but not others. I guess my question is, at the end of the day, how are we going to know that the vaccines that are out there next year are safe and effective, which vaccines are going to be effective and how are we going to collect and use this information to inform our decisions next year?”15
 
The new 2013/2014 influenza vaccine manufacturer product inserts are available to the public and links are on our Influenza webpage.
 
Stay Informed by Plugging Into NVIC
 
According to reports made to the ACCV, adult vaccine injury claims now outnumber vaccine injury claims involving children. Adults must be watchful and ready to defend their informed consent rights because vaccine mandates are not going to be just for children in the future.
 
NVIC Advocacy Portal - Sign up for NVIC’s advocacy portal to receive alerts about state legislation that proposes to add new child or adult vaccine mandates or take away legal vaccine exemptions for medical reasons or personal beliefs. As an NVIC Advocacy Portal user, you will be connected to your own state legislators via your smartphone or tablet so you can easily communicate directly with them.
 
Educate Family & Friends - Please forward this newsletter and alerts published by NVIC to your friends and family. Encourage them to sign up for the NVIC Newsletter and take action to protect their informed consent rights.
 
Become an NVIC Facebook Fan - NVIC hosts a daily online conversation about vaccination and health on Facebook. Join the more than 56,000 NVIC Facebook fans to discover new information on vaccines today! 
 
References

1 Neale, Todd. "HPV Vaccine Uptake Lagging." 25 Jul. 2013. Medpage Today. Accessed 5 Aug. 2013.
2 Markowitz, Lauri. HPV Vaccination Program & Impact Monitoring. ACIP Meeting 19 Jun. 2013. Accessed 5 Aug. 2013.
3 NVAC HPV Working Group. February NVAC HPV Session Review. NVAC Meeting 11 Jun. 2013. Accessed 5 Aug. 2013.
5 Centers for Disease Control (CDC). Report to Congress: Prevention of Genital Human Paillomavirus Infection. Jan. 2004. Accessed 5 Aug. 2013.
6 Centers for Disease Control (CDC). HPV Vaccine Information for Young Women - Fact Sheet. Last Updated 18 Jul. 2012. Accessed 5 Aug. 2013.
7 U.S. Dept. of Health & Human Services (HHS). 2020 Topics & Objectives - Immunization & Infectious Diseases. Last Updated 2013 Jul. 2013. Accessed 2013 Aug. 2013.
8 National Vaccine Advisory Committee (NVAC). A Pathway to Leadership for Adult Immunization: Recommendations of the National Vaccine Advisory Committee. 14 Jun. 2011. Accessed 5 Aug. 2013.
9 Sheedy, Kristine. Adult Immunization: The Consumer Perspective & CDC Communication Efforts. ACIP Meeting 21 Feb. 2013. Accessed 5 Aug. 2013
10Jernigan, Daniel. CDC NCIRD Influenza A H7N9 Update. ACIP Meeting 20 Jun. 2013. 5 Aug. 2013.  
11 Centers for Disease Control (CDC). Avian Influenza A (H7N9) Virus. Last Updated 2013 Jul. Accessed 5 Aug. 2013.
12 Ibid. 10
13 Ibid. 10
14 Robinson, Robin. HHS H7N9 Vaccine Response. NVAC Meeting 2013 Jun. 2013. Accessed 5 Aug. 2013.

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