The Informed Consent Imperative

The Informed Consent Imperative.

Source: ICAN (Informed Consent Action Network)(A) – Legal Team. Aaron Siri ESQ Lead Counsel.

Issue: The protection of individual Medical Autonomy.

What is informed consent ?

It means that every individual have the right and ability TO consent or NOT to consent to medical interventions, based on information provided doctors, medical professionals, scientists, existing medical studies, test- and experimental studies, clinical trials, medical safety and efficacy evaluation protocols and your own personal research on each specific topic. Each individual first get informed, then they decide whether TO consent or NOT to consent.

These are the 6 basic questions that needs to be asked and answered before any decision on medical intervention should take place.

1. Does the Manufacturer stand behind the Product or medical Intervention ?

- Is there a warranty ?

- Is there a Guarantee ?

- Is it safe ?

- What happens if it brakes / fails ? Are you going to repair / fix it ?

- Is there documented experimental and evaluated data available ?

- What are the risks versus the benefits ?

In reality. When it comes to most vaccines on the market, the manufacturers does NOT stand behind their vaccine products. The Vaccine schedule (1950-2018 ) up until 1986, Many manufacturers of vaccines tried to survive with their own brands. there where only 3 routine childhood vaccines; DTP (Diptheria, Tetanus, Pertussis), OPV (Polio) and MMR (Measles, Mumps, Rubella). Smallpox was discontinued in 1972. Reality outcome prevented the number of vaccines on the market. The amount of harm they caused to children was so great and there were so many lawsuits and financial harm (litigation costs) to the manufacturing companies that they choosed to go out of business or stop making vaccines. In the beginning of the 1980:s there were only 3 manufacturers for the 3 routine vaccines left on the marketplace. Up until 1986, the CDC (Center for Disease Control and Prevention)(B) recommended 12-shots (25 antigens, 8 diseases) in its childhood vaccine schedule. In 2023 that number has increased to 59-shots (71 antigens, 17 diseases). Why this "evolution" ? In 1986, the 3 manufacturers convinced US Congress to grant them immunity to dangers caused by their vaccine products. Instead of them having to make a much safer and better product, the US Congress passed the National Childhood Vaccine Injury Act in 1986 (C)wich permitted the manufacturers to continue selling their product, irrespective of the level of harm they caused. The problem is that, not only did the US Congress grant the manufacturers immunity for theese 3 routine vaccines, they also got immunity for ANY future childhood vaccine product. No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine. Immunity is also given for any future "emergency" related vaccines and relates to the PREP-Act (Public Readiness and Emergency Preaparedness Act 2005)(D).

When searching other products on any market, I have not been able to find any other consumer product granted with immunity of this magnitude. Giving immunity to any manufacturer disincentives safety – always. Liability drives consumer product safety – always.

2. Did it´s Clinical Trial Prove it was Safe ? 16:14

A: Placebo-Controlled Clinical Trials, are critical for assessing safety because they can prove causation of any harm and the product.

"Unfortunately", regulations dictate that you can not do any placebo-controlled clinical trials after the product is licensed, only before it is licensed.

So, the Placebo-Controlled Clinical Trial before licensing of the product is very important indeed.

Trials and tests after licensing a product will never assert any causation between the product and any degree of harm, it can only give rise to various degrees of concern. Health authorities will never reach any conclusions that can prove any causation between a licensed product and various numbers and degrees of harm. It can then only result in "concerns" and minor advisory notes. That is the regulations, dictated by the manufacturers themselves as it seems. Any injury by any licensed product can only be hypothetically correlated – not definitively caused.

(Enclosed Link of M.D. Stanley Plotkin (E)(1,2) (world´s leading authority on vaccines) ontestifying deposition on January 11, 2018, about clinical trials-harm-risks-ethicacy and ingredients in vaccines).

1. https://youtu.be/vhNGu3jFylU?si=lrgXOSIiol7G-mde

2. https://youtu.be/Ms_FbdWq2G4?si=1nmuMYZaD72Uanrx

3. Questions to Ask when Assessing a Clinical Trial and the Risk factor.

1. Duration safety reviewed ?

Days, weeks, months, years ? Longer = often more reliable trial.

2. Proper control ?

Large comparison groups. Exposure group vs placebo group. Total comparison and statistical number outcomes.

3. Enough people ?

Large groups (numbers) of exposed. Larger = often more reliable trial.

Worth of notice: The Manufacturer of the vaccines are those who will conduct the studies and the trials. This is many times questionable and complicating because it will raise concerns of financial and operative bias and double interests at play. Adding to this, the pharmaceutical companies hire professional epidemiologists and medical experts to conduct oversight and inspection of their own trials. Theese experts are often clustered in various medical companies providing investigative and oversight control of clinical trials. Unfortunately the bias is hard to ignore, since many of the medical experts set to control the vaccine companies clinical trials, themselves has been employed or have had financial ties to the same companies that they now would control. Many has pointed this out as a "Revolving door" between the manufacturing companies and the control companies and other medical experts set to control the clinical studies.

There is an entity that is supposed to be non-biased wich is an organisation called DSMB (The independent data and safety monitoring board) (F)(which allegedly does not take funds from the manufacturing companies ?) that conduct oversight over clinical and other test trials. Some of the medical esperts on this board though, have had positions of employment in the same pharmaceutical companies they are set to oversight. One major example of this is Dr. Kathryn Edwards (Principal Investigator, Clinical Immunization Safety Assessment (CISA) Projec. Also Member of the Data Safety Monitoring board for Pfizer´s COVID-19 Vaccine trials. Also Co-Author to the book "Plotkins Vaccines") was directly before her position at the DSMB employed and payed by Pfizer. The Pharmaceutical companies upholds a circulatory system of influence and they seek and employes the most prominent scholars, epidemiologists and medical experts who leaves and returns in different capacities of employment or control / oversight companies and the license authorities, it is hard to separate bias or interdependency from independency. Many have underlined the issue of "revolving doors" in the Pharmaceutical industry and its many satellite companies.

If something of major concern comes up under a clinical trial, there are instances when they need to report to the FDA (Food and Drug Administration) (G) and correspond regarding precautions, restrictions or other advisory topics regarding certain products. However, more than 50 % of the FDA budget comes from the Pharmaceutical companies themselves wich is far from an ideal situation regarding financial bias and dependency issues. The manufacturers seek their products to be licensed by the FDA and pays the FDA for each licensed product.

Some links (3,4) regarding how to determine 1-Duration, 2-Control and 3-Size of a Clinical Trial:

3. https://icandecide.org/72-vaccine-doses-no-placebo-trials/

4. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

In every case before a court of law, any vaccine victime and his/hers lawyers, has to prove causation with a certain vaccine product. Since 1986 (vaccine manufacturers gets immunity), no one can sue the vaccine manufacturers, so the only one left to sue is the federal government !! When the 1986 Congress gave immunity to the Pharmaceutical companies, they recognized it would leave a void. Individual must therefore bring any claim before a federal court of claims. So the congress put up the NVICP (National Vaccine Injury Compensation Program)(H)administered today through the HRSA (Human Resources & Services Administration)(I) wich is a department of the federal government, and counterpart in any vaccine injury lawsuit, in wich the CDC (Centers for Disease Control), the FDA (Food and Drug Administration) and the NIH (National Institutes of Health) is located. Theese organisations are equipped and statutory required to fight any individual who claims any vaccine injury before a court of law. The legal claims of vaccine injury is directed against the DOJ (Department of Justice) who uses all experts, corporate knowledge and legal resources to fight any individual claim. Vaccines is the only product, were the government defends the company against the consumer vs the consumer against any company.

So, one would think that it would be helpful to have a report reviewing all studies of commonly claimed serious injuries from vaccines. CDC and HRSA actually commission such a report in 2012 in wich they compiled this data:

Link (5) Reviewing report.

5. https://pubmed.ncbi.nlm.nih.gov/

What this report compiled was a closer look at 158 most common serious injuries claimed from vaccines. The CDC and HRSA paid the IOM (Institute of Medicine) (J) (created by congress) review these 158 most common injuries claimed from vaccines. That included all existing clinical trials before licensure and studies after licensure on those most serious injurie claims.

Link(6) 158 most common injuries from vaccines.

6. https://nap.nationalacademies.org/read/13164/chapter/2

Result of the above report:

Of the 158 serious harms studied:

For 18, evidence supported a causal relationship.
For 5, evidence rejects a causal relationship.
For 135, evidence insufficient to reach conclusion.

It is disturbing to relize that on 135 of the most serious vaccine injury claims, there has never been any sufficient studie and/or there is lack of data or unclear data to reach any conclusion. How do any individual or parent to child, go forward and give consent to any medical intervention for at least 153 of the 158 interventions ? It is getting more and more impossible based on this context. It is imposible to compare and assess the RISK versus the REWARD consenting to most of these interventions for any individual. Even if one individual clearly can see the BENEFITS taking one specific vaccine product, how can one actually consent to such a procedure if there is no possibility to assess any data of the potential RISKS ??

In this environment, this is why the individual CONSENT – part is so important. It should never be at risk of being taken away !

4. What are the Benefits of the Product ? 54:00

Before taking any medicine always ask:

Do I need this Product ?

Am I at Risk ?

Always seek the information of manufacturer responsability, age group, duration, proper study, placebo trial, enough people participating and the result of those trials conducted to assess potential risks vs benefits before allowing any medical intervention.

Always search for the mortality and health/complications data of any sickness or disease before considering any vaccine product.

Always avoid the fear mongering campaigns from media, industry and politics before and under any "new" vaccine product outroll on the public. The Pharmaceutical industry has vast financial resources and will use their influence to enhance the benefits and marketing of their products in helth institutions, media, politics and tech/social search engines and platforms.

Link(7) CDC-Mortality chart for ex; Measles.

7. https://icandecide.org/wp-content/uploads/2023/10/cdc-reported-cases-and-deaths-m-vaccine-preventable-diseases-3.pdf

What is an obvious trend is often that the actual deaths from many diseases dramatically declines under a period where public health, food and hygiene standards in general advanced in society as knowledge spread about its importance. The death rate data plummeted during this period before any vaccine was ever introduced. Widespread knowledge about this fact would have made it almost impossible for the vaccine manufacturers to spread their products. In the case of the measles the first measles vaccine was distributed in 1963, while the death data for measles had plummeted towards almost insignificant risks for several years before any vaccine introduction.

Ex; current MMR (Measles, Mumps and Rubella) vaccine licensed in 1978 was based only upon:

834 Children.
No Control Placebo studies.
42 days of safety review.
Similar trial data relied upon the license original MMR in 1971.

The FDA-licensing of many vaccines are unfortunately often underpowered, has NO-Control studies and the safety reviews is to short.

In the immunity Act of 1986 congress required the CDC to create the vaccine information statement to be enclosed for each specific vaccine product to at least inform the public about the degree of adverse events and if they would occur more often, common or rarely. Before administer any vaccine to any individual, the doctor responsible for the administration must display this vaccine information statement for the patient to read before being injected or not.

5. Can You Determine if the Risk Outweighs the Benefits ? 1:10:55

- If Risks are NOT clearly established, no one can judge if risks outweighs benefit.

Make sure the Risks of any medical product and intervention are documented, assesst and pre-licensed with proper numbers and placebo group trials. This is were many products actually fails in reliability.

6. Can You Trust the People Recommending the Product ? 1:11:13

Even if you decide to allow a specific medical intervention neglecting to absorb all the information, aspects and data we just wrote about under the above stated questions, and just choose to trust the CDC, the FDA or my local hospital and my personal doctors advice – Then there is still a final question left – Can I trust the recommendations given by the CDC, the FDA or the local hospital or my personal doctor ?

Are they free from medical bias, pressure, financing and directives from the Pharmaceutical lobby and operating without conflicting interests as institutions, regulators and doctors ? Are these recommendations based solely and firstly on my own health benefits and can these recommendations be controlled and meeting the standards through the 6 question protocol that we just put up above ?

Link(8) Medical bias and conflicted operators.

8. https://thehighwire.com/ark-videos/aaron-siri-gives-testimony-on-the-floor-of-arizona-state-senate/

In a Congressional House report (June of Year 2000) they found financial, professional and other bias dependencies between the CDC and the FDA. They pointed out the obvious "Revolving doors" between the Pharmaceutical companies and its regulators and many inappropriate financing connections:

"The overwealming majority of members, both voting members and consultants, have substantial ties to the Pharmaceutical industry."

The HHS inspector General (report from December 2009) found the same conflicting problems:

"CDC had a systemic lack of oversight of the ethics program." Also finding that: "58 percent of committée members had potential conflicts of interest that CDC did not identify." And also: "32 percent had potential conflicts of interest that CDC identified, but did not resolve."

Unfortunately the Pharmaceutical industry and its financial and lobbying powers ino the health industry, parliaments and Mediahouses will have their way. We have vitnessed this first hand during the C19 "Pandemic" were an almost unison propaganda campaign of coercion, vaccine-mandate directives and pressure was organized and megaphoned by parliaments, politicians, health institutions and global media. If the products had been safe, effective and merited by objective trials, it would still equal coercion and be immoral mandating it. This was done despite the vaccine products lacking in safety, efficacy and trial merits. In fact it was an experiment on the global population.

We must remember that the term "MANDATES" are the tool of bullies, criminals and dictators. If a petient refuses a medical product after being conveyed its benefits and risks, then that is called informed consent. They were informed and did not consent. MANDATING over this objection is immoral and illiberal.

- Never be bullied or coerced into a medical decision.

- Do Your homework.

- Get informed, and then make a decision.

Stay Free !