After All These Years, FDA is Still “Asleep at the Switch”

By Lyn Redwood, RN, MSN, Executive Director

Background: Peter Patriarca, an FDA employee, admitted back in 1999, in a confidential e-mail obtained through FOIA, that, “… the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex.  The calculations done by FDA are not complex. I’m not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been “asleep at the switch” re: thimerosal until now”. 

Since 1999, an entire generation of children both in the US and internationally has continued to be exposed to thimerosal – and it is time for this to stop.  Nobody should be exposed to a known neurotoxin.

An Ongoing Saga: On March 30th of this year, Robert F. Kennedy, Jr., and the World Mercury Project team met with the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks, M.D., Ph.D. and his colleagues to discuss the agency’s ongoing refusal to ban thimerosal, a mercury-based preservative, from vaccines in the United States. CBER is the division of the FDA responsible for approving and monitoring the safety of all biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.

At the meeting, we presented a large amount of research showing the toxicity of thimerosal in humans, animals and cellular models, including at levels similar to those resulting from vaccine exposures.  We expressed our alarm regarding the total lack of adequate safety testing of thimerosal prior to licensure, especially given its current use in vaccines approved for infants and pregnant women and its worldwide use in millions of vaccines given to children, particularly in developing countries.  Dr. Marks promised to look over the studies and seriously consider our concerns.

Here is the correspondence that followed:

April 24, 2017: Lyn Redwood Letter to Peter Marks, FDA [PDF]

July 11, 2017: Peter Marks Letter to Lyn Redwood [PDF]

November 13, 2017: Lyn Redwood Letter to Peter Marks, FDA [PDF][Article]

One FDA Hand Doesn’t Know What the Other FDA Hand is Doing

It seems ludicrous for one arm of the FDA, the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter products to find that thimerosal and other mercury products are not generally recognized as safe and effective (GRASE) while CBER allows their widespread use in over 120 vaccines and other prescription products. In 1998, FDA issued final rules banning thimerosal and mercury product use in over-the-counter products.  Our goal at World Mercury Project is to extend that ban to all use of mercury in medical products both in the United States and worldwide.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the World Mercury Project. Your donation will help to support us in our efforts.

Autoimmune disease: Better studies needed.

For those with rheumatoid arthritis (RA) in the family: Researchers from three different universities in China, representing the fields of rheumatology, immunology, endocrinology and epidemiology, recently performed a meta-analysis . They found an increased risk of lupus and an increased risk RA – after vaccination. Autoimmunity Reviews, July, 2017: http://www.sciencedirect.com/science/article/pii/S1568997217301349?via%3Dihub

The Vaccine Safety Project – Presentation

Robert F. Kennedy, Jr.’s  comprehensive PowerPoint presentation and companion video reviews the process of vaccine approvals, recommendations, post-marketing safety monitoring and concludes with necessary recommendations for improving vaccine safety and protecting our children from vaccine injuries. We hope this presentation will be used by parents and vaccine safety advocates as a tool to educate local policy makers, state and federal legislators and public health officials who need to know the facts about our federal vaccine programs, vaccine safety and the Vaccine Injury Compensation Program.

View the video here.

View the powerpoint here.

Source: World Mercury Project.

Citizens for informed consent file petition for hearing on vaccine evidence

Vermont citizens for informed consent
(1) File petition for hearing on vaccine evidence
(2) Send notice to US DHHS 

Reference documents:
(1) http://www.vaxchoicevt.com/wp-content/uploads/2017/10/Press-release-Oct-12-2017-3.htm; and
(2) http://icandecide.com/white-papers/ICAN-HHS-Notice.pdf

News Reports:

Physicians for Informed Consent Publishes Scientific Findings on the MMR Vaccine

FOR IMMEDIATE RELEASE: October 10, 2017

Contact: [email protected]

Physicians for Informed Consent Publishes Scientific Finding on the MMR Vaccine
It has Not Been Proven that the MMR Vaccine is Safer than Measles for U.S. Children

CLICK HERE to read, download, and print the measles educational materials:

Los Angeles, Calif. — The California-based nonprofit organization, Physicians for Informed Consent (PIC), has announced the release of new educational materials to help pediatricians and parents assess the risks of measles compared to risks of the measles-containing vaccine (MMR). The educational materials were developed to provide a user-friendly educational tool from data compiled by the Centers for Disease Control and Prevention (CDC) and the National Center for Health Statistics. “Many people don’t realize that the risk of dying or suffering permanent injury from measles in the United States was very small, even before the measles vaccine was introduced in 1963,” said Dr. Shira Miller, PIC founder and president. “Therefore, vaccine safety studies must show that the risk of dying or suffering permanent injury from the MMR vaccine is even smaller.”

In the late 1950s and early 1960s, right before the measles mass vaccination program was introduced, the chance of dying from measles was 1 in 10,000 or 0.01%. However, the public is generally unaware of this figure, as the CDC publishes case-fatality rates based on the number of reported cases only. Since it is estimated that nearly 90% of measles cases are benign and therefore not reported to the CDC, the widely publicized rate is 10 times higher than what is actually found in the general population.

PIC’s measles educational materials, which include the Disease Information Statement (DIS) and Vaccine Risk Statement (VRS), provide data on total measles cases (both reported and unreported to the CDC) and available information on MMR risks. This allows for a more informed risk/benefit calculation. The documents, which have undergone peer-review and scrutiny by multiple clinical and statistics experts, are now available for public distribution.

“When determining whether any medication is safe, the standard is the risk of the disease one is trying to treat or prevent,” said Dr. Miller. “With vaccines, one must follow the same procedure to determine a safety standard. Through our educational materials, we show that it has not been proven that the risk of death or permanent injury from the MMR vaccine is less than that from measles. This is an important factor in both personal and public health decision-making.”

Physicians for Informed Consent is an independent 501(c)(3) nonprofit educational organization dedicated to safeguarding informed consent in vaccination. To read and download the Measles DIS and VRS, visit physiciansforinformedconsent.org/measles.

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CLICK HERE to read, download, and print the measles educational materials:

October 6, 2017: Without liability – should there be mandates in the first place?

Don’t forget, you still have the religious exemption – you don’t need a letter from your pastor or from your rabbi or wherever, if you claim that you, that your religion doesn’t allow you vaccinate, then that gets you out of it.” 
– Vermont Governor Peter Shumlin,  May 18, 2015

 


This fall marks the second school year in which Vermont’s parents are being blocked from filing “philosophical objections” to Vermont’s ever-expanding mandatory vaccine schedule. Vermont parents with vaccine concerns, who are not “fully vaccinating on schedule,” must now sign a religious exemption form and “attest to holding religious beliefs opposed to immunizations.” The form requires them to acknowledge they have reviewed “evidence-based educational material provided by the Vermont Department of Health.”

This “evidence-based” material is devoid of adequate scientific references to support its claims and does not fulfill Vermont law, which requires that the information include, “information about the risk of adverse reactions.” Instead, the material reads like a pharmaceutical advertisement, minus the required warnings.

The facts show that vaccines do come with risks of “adverse reactions.” That is why we are petitioning for an administrative hearing at the health department.

The facts:

Thanks to an act of Congress that went into effect in 1988, drug companies and vaccine doctors face no liability for harm their vaccines may cause: As long as their products are properly labeled and accompanied by adequate warning.

No liability – but the warnings are thereVaccine manufacturers (pharmaceutical companies) provide consumer product warnings inside “package inserts” for each vaccine. In the US, the FDA regulates the contents of these “package inserts” and lists them here. These are the prescribing information leaflets that come with the product to the doctor or health department office.

From these FDA regulated package inserts, one can plainly see that there is evidence of severe, life threatening side effects or, in some cases the risks have not been evaluated, for every vaccine approved by the CDC and required by the Vermont Department of Health.

Excerpts from package inserts

(Read more here)

  • “Deaths have been reported following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” – Merck, ProQuad Package Insert, 2017.
  • “Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.” – Merck MMR II Package Insert, 2017.
  • “Deaths have been reported in temporal association with the administration of IPV.”  – Sanofi-Pasteur Ipol Package Insert, 2017.
  • “Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.” – Sanofi-Pasteur Ipol Package Insert, 2017.

Check the facts for yourself

Here is a compilation of the latest testing and links to the prescribing information (package inserts), including adverse reaction warnings, for each and every vaccine.
– See also: Introduction to Vaccine Safety Science & Policy in the United States, a white-paper from the Informed Consent Action Network.

The Vermont Department of Health website prominently says, ”

“Parents should be able to make informed decisions based on accurate information.”

We agree. There is no excuse for failing to warn consumers and parents.

That is why Vermont has always protected the right to moral (philosophical) and religious “exemptions” to mandatory vaccine policies.
Without liability, should there be mandate in the first place?

October 1, 2017: Mercury & State of Vermont Flu Vaccine Clinics

Here’s What You Need to Know: Some Shots Will Contain 25 micrograms of mercury.

On May 18th, Vermont Public Radio listeners heard:  

You are not going to get the multi dose if you get vaccinated in Vermont.”

But just 4.5 months later, the State announced flu vaccination clinics for Vermont State Employees & Retirees. They will include shots that have 25 micrograms of mercury per dose.

Question: “Does this vaccine have the mercury-based preservative called thimerosal?”

Answer (see FAQ):

“Yes. Multi-dose vials have a small amount of thimerasol to prevent contamination and growth of potentially harmful bacteria. We will have a limited supply of thimerasol preservative-free vaccine available upon request for anyone who is allergic, pregnant or breastfeeding.”

Note: “Thimerosal dissociates in the body to ethyl mercury. The evidence for its reproductive toxicity includes severe mental retardation or malformations in human offspring who were poisoned when their mothers were exposed to ethyl mercury or thimerosal while pregnant, studies in animals demonstrating developmental toxicity after exposure to either ethyl mercury or thimerosal, and data showing interconversion to other forms of mercury that also clearly cause reproductive toxicity. The evidence for PMA comes from numerous findings of developmental toxicity in laboratory animals and interconversion data.” – State of California, Office of Environmental Health Hazard Assessment, in response to pharma attempt to delist thimerosal…

Voices for Choice asked for clarification from the Vermont Department of Health on this policy.
Read the email exchange:

[pdf-embedder url=”http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept12-2017.pdf”]

[pdf-embedder url=”http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept14-2017.pdf”]

[pdf-embedder url=”http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VTDOHSept14-2017.pdf”]

[pdf-embedder url=”http://www.vaxchoicevt.com/wp-content/uploads/2017/10/VCVCSept-14-2017-2.pdf” title=”VCVCSept-14-2017-#2″]

For more information about how to fight mercury poisoning from vaccines, please visit: www.worldmercuryproject.org

September 13, 2017

Meningitis Vaccines are required for Vermont College students but exemption forms are available. Are you uneasy about the role of marketing in leveraging parental fears to sell (and mandate) more vaccines? 

For Meningitis B Vaccines, Climbing Revenue, and Plenty of Skepticism – by SHEFALI LUTHRA
https://www.nytimes.com/2017/09/07/business/meningitis-b-vaccines.html (print-pdf)

….However, the headlines prompted by the 13 campus cases — which resulted in one death and one double amputation — helped reshape the financial prospects for the drugs. Some physicians and other industry experts are now growing uneasy about the role of marketing in leveraging parental fears to sell the meningitis B vaccines as well as other expensive vaccines for rare illnesses.

A complete Bexsero series costs $320. A competing vaccine for meningitis B, Trumenba, a Pfizer product, costs $345…