Posted: 8/26/2015 3:27:02 PM
Federal Vaccine Advisory Committee Update – ACCV and NVAC
NVIC regularly monitors meetings held by federal vaccine advisory committees, including the Advisory Commission on Childhood Vaccines (ACCV) and the National Vaccine Advisory Committee (NVAC). Both ACCV and NVAC were created under the National Childhood Vaccine Injury Act of 1986 and committee members are appointed by the U.S. Department of Health and Human Services (DHHS) to usually serve two to four-year terms.
The ACCV is charged with providing oversight and giving advice to DHHS on the federal Vaccine Injury Compensation Program (VICP) that Congress designed in the 1986 law to serve as an alternative to vaccine injury lawsuits against vaccine manufacturers and doctors.
During ACCV meetings, the U.S. Department of Justice (DOJ) and Division of Vaccine Injury Compensation (DVIC) present quarterly data on vaccine injury claim petitions filed and the length of time each petition took to process; petitions that result in federal compensation; how many cases were adjudicated by concession, settlement or through a U.S. Court of Claims decision; and how many cases were dismissed.
The Public Right to Vaccine Injury Information – The Nut Shell
In recent years, information about compensated vaccine injury claims published in the VICP Data and Statistics Report has changed - but not for the better. This report prepared by DHHS officials continues to provide limited insight into vaccine injury and death awards, despite the fact that federal law states the public has a right to additional information,1 much of which is presented in bits and pieces during ACCV meetings.
Under the 1986 law, the public is entitled to the following information about VICP vaccine injury and death petitions:
- the number of petitions filed with the VICP and their disposition, the dates of when vaccine-related injuries and deaths occurred;
- the types and amounts of awards; and,
- the length of time for the disposition of petitions;
While DHHS gives some of this information to the ACCV on a quarterly basis, the information is not as meaningful as it could be because of the way it is presented in ACCV meetings and on the VICP’s website. There is no ability for the public, or the ACCV for that matter, to connect the dots between vaccine injuries compensated by vaccine and condition over time, or to determine the reasons and any associated trends on why petitions are dismissed and claimants are denied compensation.
Transparency with the Public Not a Priority
NVIC has requested greater transparency in reporting of compensated vaccine injury claims data since 2013.2 In 2014 NVIC participated in a meeting at the ACCV’s invitation, to increase public access to vaccine injury data in accordance with the 1986 law.3
Below is an example using fictitious data of what is possible with existing vaccine injury claim data, the majority of which is presented during ACCV meetings, and submitted to the ACCV’s Process Workgroup for consideration.
On behalf of NVIC, a request was made by ACCV to the Division of Vaccine Injury Compensation (DVIC) at DHHS to investigate the feasibility for DHHS to fully integrate detailed vaccine injury claim information presented to the ACCV into the Data and Statistics Report published on VICP’s website. The response by DVIC Director Dr. Melissa Houston to the ACCV’s request was that the information currently provided by DHHS, DOJ and the U.S. Court of Claims met legal requirements and was adequate.4 In essence, the response by DHHS leaves the public with two options:
- visit and search multiple websites to compile the data on your own, if you know where to find it; or
- submit a Freedom of Information Act (FOIA) request to DHHS, which often takes months and results in the demand that a fee must be paid to get the information.
Why is more detailed data about compensated vaccine injury claims important? Because the ACCV uses this information to guide its recommendations to DHHS about vaccine safety research priorities and which vaccine injuries should be added to the Vaccine Injury Table that used by DHHS, DOJ and the U.S. Court of Claims to evaluate vaccine injury claims. It could also inform ACCV recommendations for changes to the VICP process to facilitate the awarding of federal compensation to those who are injured or die from vaccine reactions.
In short, more detailed information about compensated vaccine injury claims would better inform ACCV recommendations, as well as provide transparency by living up to the spirit and intent of preventing vaccine reactions, injuries and deaths that was intended by Congress when creating the 1986 law.
Incomplete Vaccine Injury Claim Data the Norm
During the ACCV’s last meeting in June 2015,5 NVIC once again publicly raised concerns about incomplete reporting of vaccine injury claim data and the arbitrary manner in which DHHS publishes information in the VICPs’ Data and Statistics Report. Specifically, NVIC pointed out that data published in that report were either not current or incomplete.6
In 2013 a new table was added to the report that detailed, by vaccine, whether or not a vaccine injury claim was conceded, settled, received a court decision or was dismissed.7 While the addition provided some new insight into a claim’s ultimate disposition, the data was, and continues to be, incomplete.
Instead of the table providing data since the VICP’s inception (1988), the timeframe it now spans is from 2006 to 2014.8 Oddly, when the table was first published in 2013 it contained data from 2006 to present and was updated on a monthly basis with current data.9 It was early in 2015 that DHHS made an arbitrary decision to withhold current information on vaccine claim dispositions, though it continues to be presented during ACCV quarterly meetings.10
This truth and transparency violation was also recently noted by award winning investigative journalist Sharyl Attkisson.11 The response that Ms. Attkisson received from the DHHS Health Resources and Services Administration (HRSA) during her inquiry about posting of incomplete VICP data was that “an internal decision was made to ensure that all internal data was consistent…and to update the chart only when all relevant data was available,”.
The truth and transparency concerns posed by NVIC and Ms. Attkission raise the following questions:
- Why is no data prior to 2006 on vaccine injury claim disposition (categorized by vaccine) made available to the public by DHHS?
- Why has DHHS discontinued monthly updates of vaccine injury claim disposition (by vaccine), as was done previously? Why is current data no longer considered relevant?
- Why does DHHS refuse to integrate data presented to the ACCV meaningfully into the Data and Statistics Report?
Irrelevant Additions of Data Minimize Vaccine Injuries and Death
DHHS has added new information to the VICP’s Data & Statistics Report posted online, but that information appears to be largely irrelevant or designed to minimize the significance of vaccine injury and death claims.
For example, the public now has access to the total number vaccine doses distributed (sold) in the U.S. compared against the number of vaccine injury petitions adjudicated (both those that are awarded federal compensation and those that are dismissed or denied compensation).
There is also a new narrative that precedes the actual Data & Statistics data tables stating that the majority of vaccine injuries are mild and that serious injuries are rare. However, there is no mention of the fact that the majority of vaccine reactions, injuries and deaths are never reported to the federal Vaccine Adverse Event Reporting System (VAERS),12 or that most Americans do not even know that there IS a federally operated vaccine reaction reporting system or a federal program for vaccine injury compensation with hard deadlines for filing claims.
The new DHHS narrative also lacks transparency in that there is no mention of the significant vaccine safety research gaps reported by the Institute of Medicine (IOM) in more than 20 years of published reports, most recently in IOM reports published in 1994,13 201214 and 2013.15 The ACCV uses IOM reports to make research and vaccine injury table recommendations, thus these reports are well known by DHHS.
These new additions to the VICP’s Data and Statistics Report are not required by law, and appear to serve only one purpose: to diminish vaccine injuries and deaths and promote the idea that the vaccine injured are acceptable collateral damage for the “greater good.” Perhaps this is not surprising, given the adoption by the U.S. government of cradle to the grave one-size-fits-all mandatory vaccination policies resulting from the financial public-private partnership held between the government and the pharmaceutical industry.16 17
Clearly, DHHS is reluctant to be transparent about vaccine injuries and deaths using the excuse that providing truthful, comprehensive information about compensated vaccine injury claims to the public is “not relevant” or that they have already met their legal requirements. Instead, the business of the day is to offer a minimum of information manipulated against a backdrop of federal agencies deciding what is relevant and/or adequate, while securing maximum use of all federally recommended vaccines by every American with no hesitation or questions asked.
Feds Continue Plans to Track Down Non-Compliers
The National Vaccine Advisory Committee (NVAC) has operated since 1988 and reviews vaccine science, research, supply and policy issues and makes recommendations to the Assistant Secretary of DHHS. The NVAC recently published a new report with their recommendations on how to address vaccine hesitancy.
The report, Assessing the State of Vaccine Confidence in the United States,18 details strategies for compliance with the CDC’s vaccination schedules, but does little to address confidence as it relates to vaccine adverse event data and safety concerns held by the public.
While the report purports to measure confidence in federally recommended vaccines, the real goal appears to be to get every man, woman and child living in the U.S. to comply with Healthy People 2020 vaccination goals.19 The report documents that 20 percent of parents have low confidence in the judgment of vaccine use recommendations made by the medical trade association, American Academy of Pediatrics (AAP), as a safe and effective way to prevent serious disease and 27 percent of adults didn’t trust the vaccine use recommendations made by public health officials.
The report’s solution for this crisis of faith is the identification of those who delay or decline one or more vaccines via state Immunization Information Systems (IIS) and Electronic Health Records (EHR) that health providers have been incentivized20 21 22 to use. These records are being integrated into databases at the expense of traditional medical privacy between you and your health care provider.23
Citizens can also expect their hard-earned taxpayer dollars to be spent on yet more communications to “enhance” vaccine confidence and develop “systems to support parent and community efforts to promote” vaccines. In plain language, your friends and neighbors will be tapped to talk to you if your child is not in compliance with CDC’s vaccine recommendations that children receive 69 doses of 16 vaccines starting at birth to age 18. The report’s recommendations also extend to suggesting ways doctors can persuade adults to comply with the CDC’s adult vaccination schedule24 and get annual flu shots for the rest of their lives, along with other vaccines like shingles, HPV, Hib, pneumococcal, meningococcal vaccines.25
This government sponsored coercion is designed to continually pit citizens against each other and interfere with what is – and should remain - a personal medical decision.
Strong Arm Tactics Used to Reach Goals
Although the report noted that concerns held by parents have increased over time, the overarching premise of the NVAC’s “confidence” report is that compliance with federally recommended vaccines is the societal norm in America and anyone who opposes it should be strong armed or sanctioned for non-compliance. This premise denigrates legitimate vaccine safety concerns of Americans, who are being aggressively lobbied to get every federally licensed and recommended vaccine. Many of these legitimate concerns about vaccine safety science gaps are echoed in IOM reports.26
In addition to tracking down non-compliers, the NVAC’s road plan to meet Health People 2020 vaccination goals includes recommendations that states mandate vaccine education and informed refusal statements to make it harder for parents to exercise of non-medical (religious or conscientious belief) vaccine exemptions for their children and that school vaccine exemption data be publicized. Health insurance plans will also be encouraged to implement “on-time-vaccination” as a quality control measure so the government can use it as an indicator of vaccine confidence.
NVIC’s public comments on the NVAC’s vaccine confidence report27 have emphasized that Healthy People 2020 Goals, are aspirational goals and that strong arm tactics will not inspire public trust and demonstrate a lack of respect for medical privacy. Further, a one-size-fits-all “no-exceptions” government vaccination policy does not respect the informed consent or precautionary principles and fails to acknowledge that vaccines are no different from other pharmaceutical products – they carry a risk for injury and death that can be greater for some people and those individual risks often cannot be predicted prior to use of the product.28
What You Can Do
Ask your doctor about how your personal medical information is being used and if it is being shared with others. Before receiving medical care in a doctor’s office, you are usually asked to sign a HIPAA (Health Insurance Portability and Accountability Act) form. Take steps to protect your medical privacy, if you feel that it is being compromised.
Visit NVIC’s state pages to link to your state’s Immunization Information System (IIS) and learn more about it. Laws vary from state to state. Find out if your state’s IIS is an “opt-in” or “opt-out” system. If you do not want your vaccination status or that of your child incorporated into your state’s vaccine tracking registry and/or shared with federal health officials, find out how to prevent that information from being included in your state’s IIS.
Register for NVIC’s Advocacy Portal (NVICAP) and act to protect your legal right to make voluntary vaccination decisions for yourself and your children. NVICAP issues email alerts when vaccine exemptions are being threatened (or expanded) in proposed state and federal legislation. Portal users are put in direct electronic contact with their elected representatives and receive talking points and information resources that make it easy to communicate with legislators. NVIC’s Advocacy Portal is a free public service – sign up today!
Use the illustrated NVIC Reforming Vaccine Law & Policy Guide to start the conversation with your legislators and community leaders to build relationships based on accurate facts and informed consent principles. This fully referenced guide is an invaluable vaccine education tool and now is a good time to contact your legislators because they are not in session and have more time to meet with their constituents.
Centers for Medicare and Medicaid Services – CMS.gov. EHR Incentive Programs
. The Official Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs.
Ibid footnotes 13, 14, and 15.
Posted: 8/5/2015 7:40:08 PM
by Dawn Richardson, NVIC Director of Advocacy
The California Legislature passed and on June 29, 2015 Governor Jerry Brown signed California Senate Bill 277 into law. The law, which does not take effect until July 1, 2016, removes the personal belief vaccine exemption for children attending daycare and public and private schools.
Despite some of the most articulate, accurate, passionate and vocal opposition the legislature has seen from citizens spanning all political, socioeconomic, ethnic, religious, and medical backgrounds, a pro-mandatory vaccination lobby backed by the pharmaceutical, medical trade and public health industries prevailed. Education for California public and private school children and day care attendees is now dependent upon receipt of multiple doses of 10 federally recommended and state mandated vaccines regardless of a parent’s personal belief or religious belief objections.
California Stands Alone
Against the backdrop of the rest of the United States, California stands alone in the minority. Out of the 11 states that had bills filed to remove either the personal belief/conscientious/philosophical or religious exemptions during the 2015 legislative cycle (CA, MD, ME, NC, OK, OR, PA, RI, TX, VT and WA), California was the only state where the legislature passed a bill leaving only the medical exemption. Vermont retained a broad religious exemption, but the legislature removed the philosophical exemption. The other nine states rejected the removal of any non-medical exemption.
NVIC and Many Non-Profits Opposed SB 277
The National Vaccine Information Center(NVIC), a non-profit charitable organization dedicated to preventing vaccine injuries and deaths through public education and securing informed consent protections in vaccine policies and laws, vigorously opposed this bill throughout the legislative process. NVIC wrote testimony opposing SB277 and gave testimony opposing the bill in legislative hearings and published NVIC Newsletter articles and statements of opposition, as well as issued multiple email action alerts through the NVIC Advocacy Portal and NVIC Facebook page.
The bill was also opposed by Association of American Physicians and Surgeons, California Chiropractic Association, California Naturopathic Doctors Association, California Nurses for Ethical Standards, California ProLife Council, California Right to Life Committee, Inc., Canary Party, Capitol Resource Institute, Educate Advocate, Families for Early Autism Treatment (FEAT), Homeschool Association of California, Pacific Justice Institute Center for Public Policy, ParentalRights.org and Safeminds.
Industry and Medical Trade Proponents of the Bill
The lobbying effort in support for SB277 was led by Vaccinate California and California Immunization Coalition, a project of the Immunization Action Coalition that is funded by Astra Zeneca, BioCSL, Merck, Novartis Vaccines, Pfizer and Sanofi Pasteur and CDC. The American Academy of Pediatrics and California Medical Association, which are also funded by pharmaceutical companies, were among the bill’s supporters, as well as Biocomthat represents Pfizer, Merck, GSK, Novartis, Sanofi, Monsanto and Kaiser Permanente.
Other proponents of SB277 included a long list of medical trade and government employee associations that receive state and industry funding, as well as the Secular Coalition for America, which is a 501C4 anti-religious belief lobbying organization with 50 state chapters. The Coalition recently issued a press release in Oregon stating the Secular Coalition “played a key role in passage of the bill” in California. A June 2015 article in the Sacramento Bee revealed that “drug companies donated millions to California legislators before vaccine debate.”
What the New Law Does and Does Not Do
The new law eliminating the personal belief vaccine exemption is a significant change to current vaccine exemption law and will have a profound impact on families who have chosen to delay or decline one or more vaccines for their children and want their children to have a public or private school education. Naturally, families in California are concerned and confused about how and when the new law will affect them. To help clear up some of this confusion, following is an outline of provisions in the new law and NVIC’s perspective on best options for actions that California families can take to restore the personal belief vaccine exemption for school attendance.
To fully understand the bill, parents should read the final version of SB 277 for themselves.
In summary, here is what SB 277 does and doesn’t do:
- SB 277 removes the personal belief exemption from statute for government mandated vaccines required for children to attend elementary, middle and high school public and private schools, child care centers, day nurseries, and nursery schools.
- SB 277 applies to state mandated vaccines for diphtheria, Hib, Measles, Mumps, Pertussis, Polio, Rubella, Tetanus, Hep B (except for 7th grade and up), Varicella and “any other disease deemed appropriate by the department.”
- SB 277 does not require home school students or students who do not receive classroom-based instruction to be vaccinated.
- SB 277 does not prohibit a student who qualifies for an Individualized Educational Program from accessing any special education and related services required by his/her IEP.
- SB 277 does not fully go into effect until July 1, 2016.
- SB 277 provides for a limited grandfathering of students who submit a personal belief exemption affidavit to the school prior to January 1, 2016 to continue attending public or private school after July 1st, 2016 until they enroll in the next “grade span.” The three grade spans are defined as birth to preschool, kindergarten to sixth grade, and grades 7 through 12.
- SB 277 still allows for a medical exemption and defines a medical exemption as follows: “If the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt from the requirements of Chapter 1 (commencing with Section 120325, but excluding Section 120380) and Sections 120400, 120405, 120410, and 120415 to the extent indicated by the physician's statement.”
How close was it?
The final vote on SB 277 in the Assembly on June 25, 2015 was 46 in favor and 31 opposed with three votes not recorded. That means if only eight Assembly members out of the 46 who voted in favor of the bill had changed their vote to a NO, SB 277 would be dead. Only eight votes!
The final vote on SB 277 in the Senate on June 29,2015, was 24 in favor and 14 opposed with two votes not recorded. This means that if only six of the Senators who had voted “yes” changed their votes to “No,” SB 277 could have been dead in the Senate. All of the votes are recorded here under the “Votes” tab.
NVIC sent Governor Brown a letter pointing out the inconsistencies in his position signing the bill, calling the passage and his signing of SB 277 “A Grave Mistake” and a “Violation of Human and Civil Rights.”
Options to Restore the Personal and Religious Belief Vaccine Exemptions
It is crucial for all families in California, who currently want to exercise a personal belief vaccine exemption so their children can attend school, to understand that under the new law’s grandfather clause, children can continue to attend daycare or school with the personal belief vaccine exemption IF their parents have filed that exemption by Dec. 31, 2015. If your child’s personal belief vaccine exemption is not filed before that date, your child will not be able to attend school or day care with the personal belief exemption after July 1, 2016.
With that said, the people of California still have the interim period between now and the beginning of the 2016 legislative session in January 2016 to educate their elected state Assembly Member and Senator about why it is important to restore the personal belief vaccine exemption for conscientious or religious beliefs. Given that the final votes only needed a switch of eight votes in the Assembly and six votes in the Senate to kill the bill in either chamber, there is a very strong foundation to find an Assembly or Senate member to forward a bill that will restore exemptions for religious and conscientious beliefs.
California families should register for the NVIC Advocacy Portal at http://NVICAdvocacy.org and continue to contact their state legislators and advocate for a new bill to restore personal belief vaccine exemptions in school and daycare attendance laws. It is important for California families to keep in perspective that even though SB 277 passed, a defeat was within reach in both chambers of the legislature. Also, the bill was significantly amended throughout the legislative process with multiple concessions in response to concerns voiced by legislators sympathetic to opposition to the bill. The final version of SB 277 was very different than the filed version due to strong citizen opposition.
While the final outcome that saw SB 277 signed into law by Governor Brown was still very disappointing, there is a substantive pro-informed choice foundation and public platform that has been developed this year that families in California can build upon. It is important to keep citizen support for non-medical vaccine exemptions on the front burner in the California legislature and continue one-on-one education of legislators from now until the next session.
This is not the time to stand back. Many more families and enlightened health professionals are needed to contact their legislators during this period leading up to and during the 2016 legislative cycle in order to restore non-medical exemptions prior to the effective date of SB 277 on July 1, 2016.
Other vehicles to restore the exemption are a civil court challenge or a referendum to put the question to the voters on the 2016 ballot. Because vaccine mandates are state laws, the most effective and inexpensive way to affect the laws that govern us is to educate our elected officials to pass laws that protect our human and civil rights. Again, with only eight votes in the California Assembly and six votes in the Senate making the difference between SB277 passing or failing, it makes sense to find legislators in the Assembly and Senate to carry a new bill that will restore personal belief and religious exemptions and close the gap between the handful of legislators who stand between “no exceptions” vaccine mandates and protection of informed consent rights.
What Californians Can Do Now
Responsible and consistent grassroots efforts to educate those who we elect to represent us, is the most direct and cost effective, likely to succeed strategy we can take to make and protect good laws and overturn bad laws. California residents who want to work with their legislators can start by personally meeting with and sending a letter to your California Assembly Member, Senator, and their staffs requesting that they work to reinstate the vaccine exemptions for conscientious and religious beliefs in the next session. Give your legislator a copy of NVIC’s fully referenced, illustrated guide Reforming Vaccine Policy and Law. When you see a credible news report or medical literature article that raises questions about vaccine science, policy and law or supports informed consent rights and vaccine exemptions, make an appointment with your legislators to discuss it or send it to them in a letter.
It has taken decades for pro-forced vaccination lobbyists to erode informed consent rights in vaccine laws and those rights will not be preserved or restored overnight without a lot of hard work at the grassroots level by millions of Americans taking action. While there are some organizations advocating different strategies for restoring the personal belief and religious exemptions in California, the National Vaccine Information Center will continue to advocate for active education of legislators and their staffs on a consistent basis.
We will continue to update our supporters about vaccine-related legislation at the state and federal level through the NVIC Newsletter, the NVIC Advocacy Portal and NVIC Facebook.
Posted: 7/21/2015 7:43:49 PM
by Barbara Loe Fisher
To activate and view hyperlinked references, please click once and then click any superscripted number below to access a hyperlinked reference, or scroll down to the bottom of the article to view all hyperlinked references.
It has only been a few weeks since the forced vaccination lobby rammed a bill (SB 277) through the California legislature eliminating the personal belief vaccine exemption so children will have to get dozens of doses of federally recommended vaccines or be denied a school education.1 While California was being subjected to one of the most aggressive and expensive state lobbying campaigns2 ever mounted by the pharmaceutical industry in partnership with medical trade associations funded by industry and government3 4 5 6 that same lobby was pulling an even bigger fast one on the American people in Washington, D.C.
Here comes the 21st Century Cures Act (H.R. 6),7 which is a Pharma-driven bill8 blessed by the FDA9 that seriously compromises the integrity of the FDA drug and vaccine licensing process. 10 The 362-page bill sailed through the U.S. House of Representatives on July 10, 201511 and mandates that about $9 billion dollars be given to NIH to develop more drugs and vaccines and $550 million be given to the FDA to fast track products to market.12
Bill Lowers FDA Licensing Standards
The bill allows the FDA to lower licensing standards for testing of experimental drugs, medical devices and “biological products” – a category that includes vaccines -13 14 15 so companies will no longer be required to conduct large, case controlled clinical trials16 17 18 to evaluate safety and effectiveness. Instead, FDA can accept novel statistical analyses 19 and “clinical experience,”20 such as anecdotal evidence from patients.21
It is interesting that clinical experience and anecdotal evidence will constitute “good science” for the purpose of demonstrating a vaccine is safe before it is licensed, while clinical experience and anecdotal evidence has never been good enough to demonstrate that a vaccine is unsafe after it is licensed.22 23 24 25
Greasing Skids to License Drugs and Vaccines
The 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.26 However, greasing the FDA licensure skids to make experimental drugs available for the sick and dying, who voluntarily choose to use them, is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use, is something quite different.27 28 29 30 31
Nearly every single vaccine that the pharmaceutical industry creates and the FDA licenses for child use is eventually recommended for all children and mandated by state governments for daycare and school entry.32 33 34 35 36 And, now, many adults are being brought into the vaccine mandate net as well.37 38 39
Ensuring Drugs & Vaccines Dominate U.S. Health Care
Coming on the heels of the Affordable Health Care Act,40 which guaranteed that the pharmaceutical industry and their products will continue to dominate the most expensive health care system in the world,41 42 43 44 45 46 there are so many breathtaking ways the 21st Century Cures Act will endanger the public health that it is hard to know where to begin. The word “vaccines” is not being publicly uttered by anyone sponsoring the bill. However, the Biotechnology Industry Organization (BIO), which represents more than 1,500 pharmaceutical and other health product corporations, is already crowing about how they managed to influence Capitol Hill politicians to incorporate the “Vaccine Access, Certainty and Innovation Act of 2015” into the 21st Century Cures Act.47 48
Read NVIC's press release by clicking the image to the right.
Faster Track for Vaccines You Will Have To Take in Future
So, if the Senate approves and the President signs this life-threatening bill into law by the end of this year, what will happen to the hundreds of experimental vaccines that will be fast tracked to licensure and mandated for you and your children to get in the future? Just so you know, that list includes vaccines for HIV/AIDS,49 50 51 chlamydia,52 cytomegalovirus,53 hepatitis C,54 genital herpes,55 syphilis,56 gonorrhea,57 e-coli,58 norovirus,59 tuberculosis60 and many, many more.61 62
Gutting Informed Consent Along with Science
First, the 21st Century Cures Act allows the FDA to expedite licensure63 64 of new vaccines and expand uses for existing vaccines65 based on:
- Shorter or smaller clinical trials; and
- non-traditional or adaptive trial designs and Bayesian methods of data analysis;66 and
- evidence from clinical experience instead of randomized, controlled clinical trials;67 68 and
- use of biomarkers and surrogate endpoint measures69 rather than actual clinical endpoints proving effectiveness.70
Second, the new law would allow researchers to conduct “clinical testing” of experimental pharmaceutical products on people without first obtaining their informed consent71 72 73 if “the proposed clinical testing poses no more than minimal risk.”74 75 It is not clear who decides what constitutes “minimal risk,” but presumably that will be left up to industry and government officials. It is also not clear whether minor children can be enrolled in experiments without the informed consent of their parents.
Using “Best Guess” Statistics Instead of Good Science
Just for fun, I looked up the definition of Bayesian to see what will happen if the FDA lets drug companies use that method instead of large randomized clinical trials76 77 78 79 80 to determine whether an experimental vaccine is safe or not. Here is what the dictionary says about Bayesian:
“Being, relating to, or involving statistical methods that assign probabilities or distributions to events or parameters based on experience or best guesses before experimentation and data collection and that apply Bayes' theorem to revise the probabilities and distributions after obtaining experimental data.”81
The key phrase to focus on is “based on experience or best guesses before experimentation or data collection.” While we know federal agencies have been guessing for a long time when it comes to pronouncing vaccines safe and effective due to long standing gaps in vaccine safety science,82 83 84 85 86 it is irresponsible for Congress to bow to Big Pharma and codify into law the legal right for FDA officials to use flimsy “best guess” statistical methods and unreliable surrogate endpoints to support claims that a new vaccine is safe and really works, instead of requiring vaccine manufacturers to conduct in-depth biological mechanism research and large, well-designed clinical trials.
Moving numbers around in a computer is a poor substitute for actually proving an experimental vaccine does not kill and injure real human beings before it is licensed.
Congress and Pharma: Friends with Benefits
In 1986, Congress allowed itself to be blackmailed by the pharmaceutical industry and removed most civil product liability from vaccine manufacturers87 and, in 2011, the U.S. Supreme Court declared vaccines to be “unavoidably unsafe” and completely removed all product liability from FDA licensed vaccines88 89 90 In America, nobody can sue drug companies when FDA licensed vaccines injure and kill people.
Not satisfied with a total product liability shield and with access to billions of dollars in American taxpayer money to build new vaccine plants91 92 93 and create hundreds of new vaccines,94 95 96 while getting government-paid free advertising97 and enjoying a predictable market from “no exceptions” vaccine mandates, the pharmaceutical industry is now insisting that Congress give them a free pass on the science, too.
A Consumer’s Worst Nightmare
The financial public private partnership that Congress has directed government to forge with industry through a series of federal laws created over the past 30 years,98 99 100 101 102 103 104 105 106 is a drug company stockholder’s dream and a consumer’s worst nightmare. That lucrative partnership, which is using the “greater good” club to violate the human and civil rights of the American people in the name of a highly politicized “War on Disease,” has the potential to destroy more lives than any war our nation has ever fought.
The 21st Century Cures Act is a prescription for disaster. Vaccine research, development and fast tracking should not be a part of it.
If you want to make your U.S. Senator and Representative aware of what you think of the 21st Century Cures Act, become a user of the free online NVIC Advocacy Portal. The Portal can put you in immediate electronic contact with the people you elected to represent you in Washington, D.C. so you can politely, of course, give them a piece of your mind.
Stand up for your right to know and freedom to choose.
It’s your health. Your family. Your choice.
Federal Food, Drug and Cosmetic Act. 42USC262. Sec. 262. Regulation of Biological Products. (i) Biological product defined
. The term ''biological product'' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product… applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Biotechnology Industry Organization. BIO Praises Vaccine Access, Certainty, and Innovation Act of 2015.
BIO Press Release Feb. 6, 2015. List of BIO members, including AstraZeneca, BioCSL, GlaxoSmithKline, Johnson & Johnson, MedImmune, Merck, Monsanto, Novartis, Pfizer, Sanofi Pasteur
Posted: 7/12/2015 1:12:59 PM
By Theresa Wrangham, NVIC Executive Director
The Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) met on June 24 and voted against universal recommendations for MenB vaccines. These vaccines were recently approved by the U.S. Food & Drug Administration (FDA) for use in adolescents and young adults.
Considerations used by the ACIP when making universal (Category A) recommendations for vaccines include disease incidence, and benefit for large numbers of children and adults. If the vaccine under consideration doesn’t benefit large numbers of people, it may not be universally recommended.1
Data presented during the meeting showed that a universal recommendation was not justified or cost effective. ACIP instead voted for a Category B recommendation, which means that the vaccine is available for use by doctors and upon patient request. The committee’s decision eliminates financial inequities and access via provisions in the Affordable Care Act (ACA) and Vaccines for Children (VFC) programs.
Serogroup B Incidence Low in U.S.
Invasive meningococcal disease is a bacterial infection that causes inflammation of the meninges of the brain and can lead to a serious blood infection. According to the CDC, humans are the only natural reservoir for invasive meningococcal disease (N. meningitides).2
Infection with invasive meningococcal disease requires that an individual must have a susceptibility to the disease and regular close personal contact, such as sharing a toothbrush with or kissing person, who is colonizing meningococcal organisms.
The CDC reports incidence of invasive meningococcal disease in the U.S. as rare, and cases range from 800-1,200 annually, with about one-third of disease incidence being attributed to serogroup B. About half, or 100-200 cases, of serogroup B meningococcal disease in the U.S. occurs in infants too young to receive MenB vaccines.3 4 5
During the meeting, the CDC’s presentation6 noted that incidence for all meningococcal serogroups in the U.S. is at historic lows and continues to decline despite lower than desired vaccine uptake, meaning decline in serogroup B cases cannot be attributed to vaccine.
Community Immunity to Meningococcal Disease Exists
Natural community immunity also contributes greatly to low disease incidence. Research shows that about 20 to 40 percent of Americans are asymptomatically colonizing meningococcal organisms in their nasal passages and throats.7 8 This colonization boosts individual innate immunity to invasive meningococcal infection throughout life. Infants are protected for the first few months of life by the transfer of maternal antibodies from immune mothers until they can make their own antibodies.9
The CDC has recognized high levels of innate community immunity and noted that the majority of America’s 320 million citizens10 will experience asymptomatic infection as children or young adults without complications and develop bactericidal antibodies against meningococcal disease that protect them.11 12
Even though invasive meningococcal disease is rare, there is a small minority of individuals who are unable to develop antibodies who are at higher risk for this disease.
Safety Concerns Expressed by ACIP Members
During the discussion of MenB vaccines, committee members Kemp and Belongi expressed concern relating to reports of adverse events related to rheumatoid arthritis, thyroiditis and anaphylaxis. Other committee members expressed similar concerns and Chairman Temte noted that safety had been ruled on by the FDA in their licensure of the vaccine. It is unclear if additional data will be provided in response to these concerns.
Universal Recommendation Expensive and Not Justified
A CDC cost effectiveness analyses published in 2000 revealed that universal use of meningococcal vaccines in college freshmen students would be very expensive and unlikely to be cost-effective.13 Of the 2.4 million college freshmen in the U.S., vaccinating those living in dormitories would require approximately 300,000-500,000 doses of vaccine to be administered annually. This effort would prevent 15 to 30 cases of invasive disease and one to three deaths. The associated costs were $600,000--$1.8 million to prevent one case of disease, and $7 million to $20 million to prevent one death.14 Vaccination of all college freshmen would require 1.4 – 2.3 million doses annually, and prevent 37-69 cases of disease and two to four deaths at an annual cost of $22 - $48 million.
Although this CDC report was issued prior to the licensure of MenB vaccines in the U.S., cost-effectiveness data presented during the ACIP meeting confirmed that a universal recommendation of MenB would not be cost effective.15
Consequences of Universal Vaccine Recommendations
In 2011 the CDC held a public engagement and stakeholder meeting to obtain feedback the use of meningococcal vaccines given its low incidence. The resulting stakeholder report noted choice, freedom and recommendations versus vaccine requirements and mandates as a unifying theme.16
The report also recognized that universal use recommendations previously made by the ACIP have had have far reaching consequences and have often translated into a vaccine mandate in state school attendance laws.17 The ACIP acknowledged vaccine mandates as a consequence of a universal use recommendations in their voting deliberations.
Risk in All Choices
During the public engagement process and recent ACIP meetings, many families shared their stories of suffering and loss due to invasive meningococcal disease. These stories are not unlike the stories of loss and grief we hear at NVIC about vaccine injury and death.
The ACIP was gracious with time given to these families to share their stories and requests for universal recommendation. Chairman Temte also read NVIC’s statement against a universal recommendation.
In our statement we noted that many of these families were also denied their informed consent rights. Their doctors had not told them that a meningococcal vaccine was available to them and while vaccines are not 100% safe or effective for everyone, these families had a right to have access to and make informed choices about meningococcal vaccines for their children.18
Act to Protect Your Rights
These stories also represent a larger universal truth; there is no risk free option, just the ability to decide what risk is acceptable to you when considering a medical treatment/procedure or pharmaceutical product offered by a health care provider. The public debate in legislatures today is who gets to flip that coin and make that risk decision; government or parents and adults?
NVIC tracked, monitored and analyzed over 100 pieces of vaccine related legislation across 36 states this year. Is your state next?
Protect your rights by registering for NVIC’s Advocacy Portal. NVIC provides this tool as a free public resource to empower citizens to protect their human and informed consent right to make vaccine choices free from coercion and discrimination. Once you register you will receive action alerts on legislation supporting or restricting vaccine exemptions in your state, and can access the portal and stay current with legislative up-dates, talking points, and contact your legislators with your concerns with ease. Don’t wait for someone else to protect your rights…that someone is you and your voice makes a difference!
ACIP Meningococcal Workgroup Presentation to ACIP. Considerations for routine use of MenB vaccines in adolescents. Jun. 24, 2015.
Posted: 7/1/2015 10:53:54 AM
by Barbara Loe Fisher
From flash to bang, it took the politically powerful corporate, medical trade and government lobbyists just six months this year to gut the human right to informed consent to medical risk taking and the civil right to a school education in California. They did it by enacting a new law (SB 277) signed by Governor Jerry Brown on June 29, 2015 that denies parents the legal right to file a personal belief exemption to vaccination for religious and conscientious beliefs so their children can attend school.
In order to sign the bill into law, Governor Brown had to abandon his long-standing legislative record as a champion of parental and religious rights and school education. NVIC called him out in a July 1, 2015 letter
for failing to protect California families from segregation and discrimination based on vaccination and health care choices that parents make in the best interest of their minor children.
Click the image on the right to read NVIC’s July 1, 2015 press release and make a comment below.
Brute Political Power Wielded by Government and Industry Fast Tracks Oppressive Bill Into Law
Consistently throughout the legislative process, the numbers of California citizens testifying in opposition to the oppressive bill vastly numbered those testifying in support. The ramming of SB 277 through the California legislature despite strong public opposition was an impressive demonstration of the brute power that can be wielded by the public-private partnership between government and industry dominating the U.S. health care system in the 21st century.
Disinformation about the measles outbreak at Disneyland
and vaccine safety and effectiveness was used by mainstream media outlets to forward the forced vaccination agenda in the legislature in an attempt to neutralize the growing number of citizens standing up and defending their human and civil rights in our nation’s largest state. Even though thousands of men, women and children
from all walks of life came again and again to Sacramento this year to attend public rallies
and testify against SB 277 in Senate and Assembly committee hearings, the Senate voted 25 to 10 and the Assembly voted 46 to 30 to approve the legislation after contentious floor debates.
Waking A Sleeping Giant
During the six months the bill was making its way through the legislative process, many new grassroots groups focusing on health and medical freedom issues were formed in the state with a common goal of opposing SB 277. A longtime Sacramento lobbyist commented that he had not seen so many citizens packing the halls of the state Capitol for hours to testify and hold protests on the Capitol grounds since the Vietnam war. Another observer commented that the forced vaccination bill had awakened “a sleeping giant.”
Get Vaccinated, Homeschool or Go To Jail?
California now becomes one of only three states, along with West Virginia and Mississippi, that denies children entry to daycare and school unless they get dozens of doses of federally recommended vaccines or a medical doctor grants a medical vaccine exemption, an exemption that doctors deny to 99.99 percent
of children under narrow federal guidelines. Parents who do not comply with the new law will have to homeschool their children and, if they cannot homeschool for financial or other reasons, they may be subject to truancy laws that include fines and imprisonment for failing to provide their children with an education.
Incremental Steps on the Road to Medical Tyranny
In truth, the road to medical tyranny in California began in 2012. That was the year that the same pediatrician-turned politician and medical trade groups lobbied the legislature to pass AB 2109
, a bill to force parents to get a signature from a medical doctor or state designated medical worker affirming the parent had been “educated” about vaccination before filing a personal belief vaccine exemption. NVIC opposed that bill because we knew it was an incremental step toward ramming a forced vaccination law like SB 277 through the legislature down the line, which is exactly what was done.
Citizens Push Back and Win in Other States
Vaccine use recommendations are made by federal health agencies and medical trade groups but vaccine mandates are state laws. More than 100 bills were introduced in multiple states this year to restrict or eliminate non-medical vaccine exemptions or add more vaccine mandates. The majority did not succeed.
In Texas alone, more than 20 vaccine-related bills were defeated because families across the state stood up and successfully defended their informed consent and civil rights. Although California has lost, temporarily at least, the personal belief vaccine exemption and Vermont lost the philosophical belief exemption (while retaining one for religious beliefs), citizens fought for their informed consent rights by educating their legislators and blocked bills in Washington, Oregon, Maryland, North Carolina, Pennsylvania, Maine and other states.
The Final Wake-Up Call
What happened in California in 2015 is America’s final wake-up call
. Forced vaccination bills like SB 277 that seek to eliminate all non-medical exemptions are eventually going to be introduced in every state and they will not be limited to school aged children. Adults will be targeted
, too, as government health officials, industry and medical trade groups advocate for more societal sanctions that include loss of medical care and employment to be applied to those declining to get every federally recommended vaccine.
What is at stake? If the state can tag, track down and force us against our will to be injected with biologicals of known and unknown toxicity today, there will be no limit on which individual freedoms the state can take away in the name of the greater good tomorrow.
Please get involved and actively participate in our democracy. If we do not take freedom for granted, we can reclaim and protect our human and civil rights in California and every state in America.
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