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virginia freedom keepers

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Informed consent

3/3/2021

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Virginia Freedom Keepers is a grassroots organization that rallies communities and empowers individuals to be active guardians of their right to informed consent. 

Informed consent is a patient-to-provider discussion regarding the risks, benefits, and alternatives to any given procedure or intervention followed by the right to decline said medical product or procedure without fear of repercussion. Although often overlooked, informed consent involves having a full picture of how a medical product will affect you as a unique individual with the recognition that not all of us will react the same to a given product or environment. The bio-individuality of each person is contributed to by background, ethnicity, diet, environmental exposure and endless other attributes. This unique dynamic that creates the individual does not suspend for a medical product. No medical product is one size fits all and will thus have a unique particular experience for each person. 
The American Medical Association (AMA) is the largest association of medical professionals that works to create standardized ethics, care and the betterment of public health. The AMA formally declares in their medical ethics opinion that informed consent is fundamental in areas of law and ethics and that “Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.”

Informed consent per the American Medical Association

“The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:

  1. Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.
  2. Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information. The physician should include information about:
    - The diagnosis (when known)
    - The nature and purpose of recommended interventions
    -T
    he burdens, risks, and expected benefits of all options, including forgoing treatment
  3. Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.”

Patient bill of rights and vis

Standardized informed consent procedures regarding recommended vaccinations was established in the National Vaccine Injury Act. This Act resulted in common handouts, or the Vaccine Information Statement (VIS) most parents are familiar with given at routine pediatric appointments. According to the Centers for Disease Control “A VIS or Vaccine Information Statement is a document, produced by CDC, that informs vaccine recipients – or their parents or legal representatives – about the benefits and risks of a vaccine they are receiving.” The VIS provides generic information about commonly acknowledged reactions. The VIS statements are required to contain concise understandable information and must also include information about the Vaccine Injury Compensation program.

The guidance from the AMA , along with other definitions of informed consent, leave the standard VIS lacking to meet the basic criteria that is ethically necessary for a patient to make a fully informed choice. The standardized VIS offers vague information on the most commonly acknowledged reactions while leaving out many other serious reported adverse reactions, and is not clear and direct on essential information.

Virginia freedom keepers guidelines for informed consent

In order to provide true informed consent we believe it is imperative to disclose the following; 
  1.  All vaccines on the recommended schedule are liability free, meaning that manufacturers are not held liable for any injury or death that occurs as a result of their product.
  2. All recommended vaccines carry a risk for death or serious injury.
  3. Each VIS has an expanded, more encompassing version known as a Vaccine Insert from the manufacturer that is available online or from your provider.
  4. Each vaccine is considered a biologic and not a medication. Biologics are not subject to the same standards of testing that drugs are. 
  5. There are certain religions that may find vaccine ingredients contradictory to their beliefs due to fetal or animal cell lines or culturing/testing in those cell lines in some vaccines. 
  6. Although many vaccines are recommended by the CDC in combination, no safety studies have been done to establish the level of safety or rate of adverse reaction when combining products from different companies using differing adjuvants. In addition vaccines have not been tested for carcinogenic (cancer-causing) properties or fertility impairment as stated in section 13.1 of most vaccine inserts 
  7. No independent safety commission exists to verify the safety claims by the pharmaceutical companies. The safety data comes directly from the manufacturer.
  8. VEARS is the passive monitoring system for vaccine injury and death. Studies have shown that VEARS is not capturing the majority of adverse reactions that would substantially affect current statistics if accurately reported. In fact, a grant report done by Harvard Pilgrim Healthcare found that “fewer than 1% of vaccine adverse events are reported.”
  9. Practitioners may be receiving financial incentives from pharmaceutical companies for use of their products, but they are not required to disclose this information to the patient.
  10. Medical products are not one size fits all. Biologics have unique operating mechanisms that make them inherently dangerous to segments of the population, such as those with the MTHFR gene mutation. Prior testing for risk/benefit assessment would help to determine if the individual will be tolerant of the medical product and would establish necessary data to establish full informed consent. ​
Informed consent should be presented in an unbiased, non-coercive manner that puts factual information and a patient’s bio-individuality and autonomy at the forefront. The ability of a patient to assert choice or decline without pressure is paramount in fulfilling ethical obligations regarding informed consent. As it currently stands, public health focuses regarding informed consent have a paradigm for practice that ignores and excludes these paramount considerations. This is directly contradictory to the ethics and standards of care established by both the AMA and Patient Bill of Rights. Considering the individual, giving the individual control of their healthcare choices/impacts, and ensuring true and complete informed consent is the best and most necessary practice for a healthy and thriving society.

​

sources: 

Informed consent. (n.d.). Retrieved February 18, 2021, from https://www.ama-assn.org/delivering-care/ethics/informed-consent

TITLE 42- The Public Health and Welfare (1987, December 27). Retrieved from 
https://www.govinfo.gov/content/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap6A-subchapXIX-part2-subpartc-sec300aa-26.pdf

Patient bill of rights (n.d.). Retrieved February 18, 2021 from https://clinicalcenter.nih.gov/participate/pat
ientinfo/legal/bill_of_rights.html

Electronic supporting for public health- Vaccine Adverse Event Reporting System. Retrieved February 24, 2021 from ​https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report
-2011.pdf


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LEGISLATION 101

1/11/2021

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OVERVIEW OF LEGISLATURE

The Virginia Legislature consists of the Governor, the House of Delegates and the Senate. The House of Delegates has 100 elected officials and the Senate has 40 elected officials. The district boundaries for the delegates are different than those for the senate. ​
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Currently the democratic party holds the majority in all areas of the Virginia legislature. In the last election cycle approximately 30% of all of the elected representatives ran unopposed. The House of Delegates are elected every two years while the Senate and Governor are elected every four years.

Session and special sessions

The Virginia legislature is a part time legislature which meets yearly from January until March. In the event of pertinent issues arising, a special session can be called where they meet to address specific issues predetermined by the Governor. Recently in both regular and special sessions the number of bills each elected official can bring forth has been limited.

How a Bill becomes a Law

New bills can originate from many sources. These bills typically include paid lobbyists, special interest groups, local governments, constituents and various individuals or stakeholders. 

Once a Bill is drafted it is assigned to a committee. There are fourteen committees in the house and eleven committees in the senate. These committees are all headed by the “Chair” who is appointed to lead the committee. The Chair determines which bills are heard and sets the decorum of the committee. In committee a bill can be tabled, which means it is “paused’ and will not move forward. If it is not tabled, it may be voted on. Iif the vote favors the bill, the bill moves to the full floor for a vote from all the members in that division of the legislature. 

​
If the bill is passed it will wait until crossover when it will be assigned to a committee on the side of the legislature. Crossover is when all the bills that have been passed on one side of the legislature (House or Senate) move to the other side, where the committee and voting process starts again. All bills move over on the same date. If the Bill is amended in any way, it is sent back to the originating side to be voted on again. The bill must pass by vote in both the Senate and the House written and amended in the exact same manner. If the bill were to be tabled or fail in committee, the patron can discharge the bill and bring it to the full floor for a vote. 
​

Once the Bill has passed both houses it goes to the Governor. The Governor can do one of three things - 1) sign and it will become law, 2) veto and it dies, or 3) amend it. If the bill is amended it is sent back to the legislature to be passed again in both houses with the amendments.

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January 11th, 2021

1/11/2021

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History will repeat itself: a look into the anti-DDT movement

8/20/2020

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27. That’s how many years it took for the United States government to ban DDT for agricultural use. 
 
27 years is how long the American people were exposed to a chemical that was later found to cause a wide variety of health problems including cancer, infertility, miscarriages, nervous system damage, liver damage, and more.  

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If I can't have Ibuprofen when pregnant, why is TDAP safe?

8/20/2020

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Outlined on the list of things to avoid when pregnant are things such as alcohol, changing cat litter, certain teas, raw fish, and taking ibuprofen. 

One thing that should be considered by both healthcare providers and pregnant mothers is the list of cautions and adverse reactions presented on the manufacturer insert for the TDAP vaccine. 
 
Here's an overview of what the TDAP vaccine is and some of the reactions the manufacturers have listed:

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If "Death" is listed on the insert, is it really a safe product?

8/20/2020

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The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

Recently, the FDA just recalled several hand sanitizers due to the "reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention." Interestingly, similar reactions are listed on the manufacturer insert for the Rotavirus shot, however it has not been recalled.

Here's an overview of some of the adverse reactions from the manufacturer. 

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Why do we need the MMR shot?

8/20/2020

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The CDC states on its website that, "before vaccines were available, nearly everyone was infected with measles, mumps, and rubella viruses during childhood. The majority of people born before 1957 are likely to have been infected naturally and therefore are presumed to be protected against measles, mumps, and rubella."  In other words, if I'm currently 63 years old, then I'm not at risk for a measles outbreak because I was exposed to the wild virus as a child.  This begs the question, why can't that be the case for today's children?

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Is SIDS really listed on the DTAP insert?

8/20/2020

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The short answer is "yes," but let's look deeper. Here is an overview of adverse reactions listed on the insert.

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What's in the Polio insert?

8/20/2020

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First, let's discuss what Polio is according to the CDC.
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Underreported Reactions

8/20/2020

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Take a second and think back to when you or your child received a medical treatment or product at the doctor's office.  For drugs, you most likely received a multiple-paged sheet with all the directions, contraindications, and possible side effects.  For surgery, you've had to sign some kind of disclosure that you're aware of possible negative outcomes.  But what about immunizations?  Did you receive anything?

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