Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science

Posted: 7/21/2015 7:43:49 PM | with 10 comments


by Barbara Loe Fisher

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21st Century Cures Act Eliminates Good Vaccine Safety ScienceIt 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

Sick in bedThe 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
NVIC Press Realease - 21st Century Cures
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:

  1. Shorter or smaller clinical trials; and
  2. non-traditional or adaptive trial designs and Bayesian methods of data analysis;66 and
  3. evidence from clinical experience instead of randomized, controlled clinical trials;67 68 andVaccines and guessing
  4. 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

JusticeIn 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 Join www.nvicadvocacy.orgfast tracking should not be a part of it.

Act Now

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.




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ACIP Votes Against Universal Use of Meningococcal B Vaccines

Posted: 7/12/2015 1:12:59 PM | with 6 comments

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

Serogroup B Incidence Low in U.S.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

Universal Recommendation Expensive and Not JustifiedA 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.

Risk: Two Sides One CoinThe 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!



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California Enacts Vaccine Law That Forces Parents to Choose Between Human Rights and Civil Rights

Posted: 7/1/2015 10:53:54 AM | with 20 comments

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.
 
NVIC Press Release: Enactment of CA SB277 Threatens Human & Civil Rights in AmericaClick 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.
 
Forward this article to your family and friends.
 
Sign up for the free online NVIC Advocacy Portal and educate your elected officials about protecting the human right to informed consent to medical risk taking and the civil right to a school education, medical care and employment.
 
Read and post stories of vaccine risk, failure and harassment and access well-referenced information on vaccines and infectious diseases on NVIC's website.
 
 
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