Madison Area Lyme Support Group

AUSTIN, Texas (April 8, 2019) – A bill introduced in the Texas Senate would prohibit vaccines from being administered unless certain safety criteria are met. Passage of the bill would significantly strengthen vaccine safety testing requirements and push back against any future federal vaccine mandates.

Sen. Bob Hall (R) introduced Senate Bill 2350 (SB2350) on March 8. The legislation would only permit a health care provider to administer a vaccine if all of the following criteria are met.

• The study the U.S. Food and Drug Administration (FDA) relied upon for approval of the vaccine evaluated the vaccine against a placebo control group or against another vaccine or substance that the FDA approved based upon a placebo-controlled study;
• The study relied upon by the FCA for approval of the vaccine evaluated the safety of the vaccine for a sufficient time to identify potential autoimmune, neurological, or chronic health conditions that may arise on or after a year from the vaccine being administered;
• The vaccine has been evaluated for its potential to cause cancer, mutate genes, affect fertility, cause infertility and cause autism spectrum disorder;
• The Texas Department of State Health Service has posted on its website disclosure of any known injuries or diseases caused by the vaccine and the rate at which the injuries or diseases have occurred; and
• The chemical, pharmacological, therapeutic, and adverse effects of the vaccine and the rate of injury of the vaccine when administered with other vaccines, have been studied and verified.

Effect on Federal Policy

After recent comments by former FDA Commissioner Dr. Scott Gottlieb in February of 2019 just prior to his resignation, some believe that federal vaccine mandates are imminent.  According to CNN, Gottlieb said,

“[I]f states don’t require more schoolchildren to get vaccinated, the federal government might have to step in.” Gottlieb also reportedly said, “You could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions.” [1]

As discussed below, current vaccine safety testing requirements are far less stringent than most would assume.  Passage of SB 2350 would bolster these requirements and make enforcement of any federal vaccine mandates more difficult.

Number of Recommended Vaccines Steadily Rise Since Removal of Liability

Vaccine mandates are generally based upon the vaccine schedules recommended by the Centers for Disease Control and Prevention (CDC). Because vaccines pose a risk of injury or death, liability is associated with them. Many Americans are unaware that the pharmaceutical industry is shielded from liability for harm caused by most vaccines. This unique legal protection was put into place as a result of legislation passed in 1986, after extensive lobbying by the pharmaceutical industry. Manufacturers of other products don’t enjoy this freedom from liability. Due to lack of liability, vaccines are the pharmaceutical industry’s most lucrative product.

The 1986 law also created the National Vaccine Injury Compensation Program (NVICP), which is essentially a special system outside of the normal litigation process to hear claims of harm caused by vaccines. Any compensation granted by the NVICP is paid by the public, through a surcharge on vaccines, and not by vaccine manufacturers. To date, over four billion dollars has been paid under this system to compensate for harm caused by vaccines. [2]

Further, although discovery is a right afforded to litigants in most other legal forums, discovery is not permitted in the NVICP process. This protects vaccine manufacturers from having to search for, and produce, relevant information, including damaging information. In cases involving prescription medication, which are heard in other legal forums, information unfavorable to the pharmaceutical industry has come to light through discovery, such as the damaging e-mails which were required to be produced in the Vioxx litigation. [3]

In the absence of pharmaceutical industry liability for most vaccines, the number of vaccines recommended by the industry and the CDC is steadily rising. For example, in 1983, the CDC recommended that children receive 23 doses of seven vaccines. By 2017, the number of vaccines it was recommending rose to 69 doses of 16 vaccines starting on the day of birth to age 18, with 50 doses of 14 vaccines given before age 6. [4] Since 2002, a CDC adult vaccine schedule has also existed. [5] Like with the childhood schedule, the number of recommended vaccines and doses on the adult schedule has continued to rise. Furthermore, there are hundreds of new vaccines in the developmental process and the number of CDC recommended vaccines is expected to continue to rise.

Inadequate Vaccine Safety Testing

Lack of adequate safety testing is a common concern of opponents of mandatory vaccines and SB 2350 addresses this critical issue.

Many Americans believe that vaccines undergo the same safety testing as drugs prior to their approval. However, this is incorrect. In fact, vaccines and drugs are subject to different rules because the FDA has chosen to classify vaccines as “biologics” rather than “drugs.” Drugs are required to undergo multi-year, double-blind inert placebo studies, widely known as the gold standard of safety science, prior to licensing. Vaccines, on the other hand, are not required to undergo inert placebo-controlled studies for approval. [6] Furthermore, unlike the lengthy periods required for drug safety studies, vaccine safety studies monitor for adverse reactions for very short periods of time, often of fourteen days or less. [7] Additionally, although children frequently receive multiple vaccines at the same time in accordance with the CDC’s recommended schedule, vaccine manufacturers are not required to test the safety of the vaccines in these combinations. [8]

In fact, there is a multitude of reasons, in addition to inadequate safety testing, to question the mandating of vaccines. For example, the ingredients in them are often cited as a source of concern. The ingredients in each type of vaccine differ but, generally, vaccines contain a myriad of toxic or concerning substances such as aluminum, antibiotics, formaldehyde, Polysorbate 80, bovine extract, egg protein, monosodium glutamate (MSG), squalene, and aborted human fetal tissue. [9], [10]. Additionally, several recently published books set forth scientific information which raises concerns about vaccines, including the book Miller’s Review of Critical Vaccine Studies: 400 Important Scientific Papers Summarized for Parents and Researchers by Neil Z. Miller, which contains over 400 peer-reviewed scientific studies. [11] In another book, Vaccines – A Reappraisal, Dr. Richard Moskowitz, a family physician with over fifty years of experience, discusses a wide range of troubling information concerning vaccines, such as:  epidemiological research which indicates that vaccines may interfere with the normal development of a healthy immune system; information concerning the role that vaccines can play in causing infectious disease outbreaks; and evidence of the surprisingly low effectiveness levels of many vaccines. [12] J.B. Handley’s book How to End the Autism Epidemic also contains a wealth of information concerning potential harm caused by vaccines, particularly focusing on aluminum, a toxic metal used as an adjuvant in many vaccines, and on evidence of a causal link between vaccines and autism. [13] As these works clearly indicate, the science is not settled with regard to whether vaccines are safe or necessary.

State Action Needed

Federal regulation becomes ineffective when states enact contradictory policies. If multiple states ban mandatory vaccinations or pass laws which conflict with the CDC’s recommended schedules, it will become extremely difficult for the federal government to enforce future federal mandates. Such state laws will also undermine the federal narrative and make it harder for the feds to generate support for nationwide mandatory vaccine policies. By passing SB 2350, Texas has the opportunity to lead on this important issue and to become the potential standard bearer for resisting federal vaccine policy at the state level.

NOTES

[1] Cohen, Elizabeth and Bonifeld, John, “FDA chief: Federal government might step in if states don’t change lax vaccine laws.”  CNN.com. Cable News Network. Web. 20 Feb 2019, https://www.cnn.com/2019/02/20/health/vaccine-exemptions-fda-gottlieb/index.html.  Accessed 7 April 2019.

[2] Children’s Health Defense. “$4 Billion and Growing:  U.S. Payouts for Vaccine Injury and Deaths Keep Climbing.” www.ChildrensHealthDefense.org. Web. 19 Nov. 2018,   https://childrenshealthdefense.org/news/4-billion-and-growing-u-s-payouts-for-vaccine-injuries-and-deaths-keep-climbing/. Accessed 7 April 2019.

[3] Berensen, Alex, “Jury Finds Merck Liable in Vioxx Death and Awards $253 Million.”  nytimes.com. Web. 19 Aug. 2005, https://www.nytimes.com/2005/08/19/business/jury-finds-merck-liable-in-vioxx-death-and-awards-253-million.html. Accessed 7 April 2019.

[4] National Vaccine Information Center. “A Guide to Reforming Vaccine Policy and Law.” http://www.nvic.org. Web. 26 Sept. 2018, https://www.nvic.org/Vaccine-Laws/state-vaccine-requirements/Reforming-Vaccine-Policy—Law-Guide.aspx. Accessed 7 April 2019.

[5] Centers for Disease Control and Prevention, Immunization Schedules, Table 1. Recommended Adult Immunization Schedule for ages 19 years or older, United States, 2019. Web. 5 Feb. 2019, https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html. Accessed 7 April 2019.

[6] Robert F. Kennedy, Jr. “Vaccines and the Liberal Mind.” Children’s Health Defense. www.ChildrensHealthDefense.org. Web. 14 June 2018, https://childrenshealthdefense.org/news/vaccines-and-the-liberal-mind/. Accessed 7 April 2019.

[7] Moskowitz, Richard, Vaccines – A Reappraisal. New York, New York: Skyhorse Publishing, 2017. 31-42. Print.

[8] Imus, Deirdre.  “Toxic Vaccine Ingredients:  The Devil is in the Details.”  www.ChildrensHealthDefense.org. Web. 6 March 2018, https://childrenshealthdefense.org/news/toxic-vaccine-ingredients-the-devils-in-the-details/. Accessed 7 April 2019.

[9] Ibid

[10] National Vaccine Information Center. “New Human Fetal Cell Lines Available for Vaccine Production.”  http://www.nvic.org. Web. 15 Jan. 2018, https://www.nvic.org/nvic-vaccine-news/january-2018/new-human-fetal-cell-lines-for-vaccine-production.aspx. Accessed 7 April 2019.

[11] Miller, Neil Z., Miller’s Review of Critical Vaccine Studies: 400 Important Scientific Papers Summarized for Parents and Researchers, Santa Fe, New Mexico: New Altantean Press, 2016. Print.

[12] Moskowitz, Richard, Vaccines – A Reappraisal. New York, New York: Skyhorse Publishing, 2017. Print.

[13] Handley, J.B., How to End the Autism Epidemic. White River Junction, Vermont: Chelsea Green Publishing, 2018. Print.

Tags: SB2350, Texas, Vaccines

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