By Dr. Mercola
The Vaccine Reaction, published by the non-profit National Vaccine Information Center (NVIC), recently highlighted a really disturbing part of the 21st Century Cures Act that has largely escaped below the radar.
The 21st Century Cures Act, which was quickly pushed through Congress and became law back in December 2016, allows the waiving of the requirement of informed consent for participants in clinical trials if researchers believe an experimental medical device, drug or vaccine being tested poses no more than minimal risk to the patient’s health, or if the product being tested is deemed by researchers to be in the best interest of trial participants.
The Act also lowers FDA standards for the quality of evidence that drug companies have to provide to the FDA before drugs and vaccines are licensed and sold in the U.S.
In a nutshell, scientists testing pharmaceutical products like vaccines may now choose to experiment on human beings without obtaining informed consent first.
As noted in the featured video, this really boils down to slavery — you can be experimented on without fully understanding the potential risks of the product you are being given if you are a participant in a clinical trial, which means you do not have the opportunity to exercise informed consent and opt out.
21st Century Cures Act Waives Informed Consent for Low-Risk Medical Testing
Section 3024 of the 21st Century Cures Act refers to Informed Consent Waiver or Alteration for Clinical Investigations, amending some of the wording in section 520(g)(3) of the Federal Food, Drug, and Cosmetics Act.
As noted in the video, subparagraph D in this section received a minor update by removing the words “the investigator,” but the remainder still stands.
Section 3024(a), which covers “medical devices,” basically states that informed consent is required when researchers are testing medical devises in clinical trials “except where, subject to such conditions as the Secretary may prescribe, the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”
Section 3024(b), which covers drugs, states informed consent is required “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings.”
How giving informed consent could ever be contrary to your best interest is a question worth pondering.
I cannot conceive of a situation where that could possibly be true but, apparently, people elected to govern on our behalf believe there are situations warranting suppression of the fact that you are participating in a scientific experiment that could harm you or your minor child.
Government Admits Vaccines Are ‘Unavoidably Unsafe’
Historically, vaccine trials have always been assumed to involve more than minimal risk. In fact, both the U.S. Congress and the Supreme Court have concluded that government licensed vaccines are “unavoidably unsafe.”1
This determination was one reason given by Congress for why vaccine manufacturers were given a civil liability shield from vaccine injury lawsuits in the National Childhood Vaccine Injury Act of 1986.
This “free pass” means that if a FDA licensed and state mandated vaccine ends up injuring or killing you or your child, the vaccine manufacturer or the doctor who administered the vaccine cannot be sued in civil court.
As a result of having zero liability for harm arising from the use of their products, drug companies are creating hundreds of new vaccines and plan to churn out and fast-track an ever-growing number of poorly tested vaccines with dubious benefits.
At the same time, there’s a concerted, nationwide lobbying effort by industry, medical trade groups and public health officials to eliminate the right of parents to make voluntary vaccine choices for their children by removing religious and conscience vaccine exemptions that have been included in state vaccine laws for the past half century.
To top it all off, the 21st Century Cures Act appears to provide a mile-wide loophole for pharmaceutical companies to test their products on human beings without informed consent and fast-track them to market using lowered licensing standards. I don’t know about you, but this strikes me as an absolute nightmare in the making.
While vaccine makers have been granted immunity against lawsuits for injuries and deaths caused by vaccines, children injured by vaccines are supposed to be able to receive swift and just compensation from the federally operated vaccine injury compensation program (VICP), created by Congress in 1986 under the National Childhood Vaccine Injury Act.
However, this program was gutted by the Department of Health and Human Services and Department of Justice within years of the 1986 law’s enactment and has only gotten worse over the years, again protecting vaccine manufacturers’ interests more than anything else.
The National Childhood Vaccine Injury Act
The U.S. Court of Federal Claims in Washington DC handles contested vaccine injury and death cases in what has become known as “vaccine court.”2
VICP is a “no-fault” alternative to the traditional civil court lawsuit and was established in 1986 after a string of high-profile lawsuits by parents of vaccine injured children had hauled vaccine manufacturers into court to have their cases heard in front of juries.
At the time, parents were suing vaccine manufacturers after their children were brain injured or died following federally recommended and state mandated DPT (diphtheria, pertussis, tetanus) vaccines, or children were left paralyzed by live oral polio vaccinations (OPV).
Several DPT injury lawsuits against the vaccine makers in the 1970s and early 1980s resulted in multimillion-dollar jury verdicts.
At that point, vaccine manufacturers threatened to stop producing DPT, MMR and oral polio (the only childhood vaccines at the time) if civil litigation was allowed to continue.
Common sense would have dictated that such lawsuits were a sign that vaccine manufacturers needed to raise safety standards and produce less toxic vaccines.
Instead, Congress buckled to industry pressure and, declaring that the U.S. vaccine supply must be protected, passed the National Childhood Vaccine Injury Act, giving vaccine manufacturers the legal protection they demanded.
As a result, vaccine makers have no incentive to produce the safest vaccines possible, especially when many childhood vaccines are state mandated for school attendance and 2 out of 3 vaccine injured children are turned away from the VICP with no compensation.
Vaccine Court Is No Safeguard for Vaccine Injured Patients
Over the years, it has become quite clear that VICP doesn’t work as Congress intended or promised parents it would work. In a recent article published in The American Conservative, vaccine litigation lawyer Robert Moxley writes:3
“… [VICP] was modeled after workers’ compensation programs. It was to be a ‘no-fault’ program … As one of the earliest ‘vaccine attorneys’ … I know first-hand it didn’t work that way.
I practiced in the National Childhood Vaccine Injury Compensation Program for more than 25 years after its inception in 1988, and have been personally involved in over 100 vaccine-injury cases. I represented an entire fragile population in omnibus proceedings … I have seen the injured and their families cruelly oppressed.
From the passing of the legislation in 1986, the process has been rigged … in favor of the vaccine-industrial complex. Policy makers nationwide are yearning, with financial support and lobbying from the pharmaceutical industry, for mandatory vaccination. Before further compulsory vaccination legislation passes … the failure of the VICP must be acknowledged and properly addressed.
The VICP creates a classic moral hazard, granting immunity from suit to the vaccine industry while providing insurance against any loss …The vaccine-industrial complex has become a thriving giant … Its lobbying money drives agency denial of the reality of vaccine injury, which in turn permeates policy decisions in a sinister fashion.”
VICP — A Bureaucratic Nightmare That Offers Little Protection
As noted by Moxley, the National Childhood Vaccine Injury Act states the entire compensation process should take 240 days at most, and since it’s a “no-fault” program, it was designed to compensate patients for “apparent” injuries, meaning injuries that “appear” to be related to a vaccine even if you cannot conclusively prove it.
Congress promised compensation would be awarded “quickly, easily, and with certainty and generosity,” in order to instill public confidence in the childhood vaccination program. The reality is much different. In his article, Moxley highlights a number of serious problems with the VICP, including the following:
- Lawyers are few, as the program prohibits private attorney’s fees; many who suffer a vaccine injury cannot even meet the filing deadline due to inability to retain legal counsel
- The process is exceedingly slow, with the average case taking over five years to adjudicate — a far cry from the 240-day deadline originally set by Congress for all adjudication decisions; some cases remain pending a decade after they were filed
- Two-thirds of claims received are dismissed4
- Decisions cannot be used as precedents for other cases
- The Department of Health and Human Services has not publicized the program, which was and still is its statutory duty
VICP Protects Vaccine Makers’ Interests
Moreover, as noted by Moxley: “The ‘inquisitorial’ format, with none of the due process safeguards of the civil justice system, serves to protect the secrets of the vaccine industry. The record created in a proceeding is hidden from non-parties.”
Indeed, none of the information that would normally be disclosed during a court trial ever sees the light of day once brought before the VICP. Hence, safety concerns remain shrouded in secrecy.
“A state of symbiosis arose between the agency tribunal and the public health bureaucracy,” Moxley writes. “These sister agencies appeared to regard families of the injured as criminals, trying to steal the government’s money. The vaccine court quickly developed an institutional hostility toward doctors and scientists who dared to challenge the orthodoxy of vaccine medicine …
An unspoken premise is ever-present: [T]o acknowledge vaccine injury is to undermine public acceptance, and to threaten ‘herd immunity.’ The public health agenda is the tribunal agenda and the DOJ agenda as well …
The vaccine court is used by the vaccine program — ostensibly in service of the ‘public health’ — as a forum to prove that there is no such thing as a vaccine injury. ‘Confidence’ in the safety net has been subordinated to the promotion of false confidence in the vaccination effort itself.
The moral hazard of the vaccine program reflects failure of the traditional checks and balances … Most of all, the entire system embodies the way that the lack of accountability leads to increased risk. Today, the proponents of compulsory vaccination in state legislatures have the temerity to tell their colleagues that there is no such thing as a vaccine injury. This claim emboldens a potential assault on the American family, and against the right of medical choice and informed consent.
The ‘public health’ cannot be served to allow government officials to make the risk-benefit calculation for their most vulnerable constituents when those decisions are corrupted by the fiction that their decision has no potential for negative consequences.”
Who Pays for Vaccine Injuries?
VICP compensates vaccine victims from a federal trust fund that collects a 75-cent surcharge on every vaccine given. What this means is that not only are drug companies profiting from selling federally recommended and state mandated vaccines to government for administration in public health clinics and to private doctor’s offices, pharmacies and HMO providers, vaccine manufacturers are also held legally blameless for vaccine injuries and deaths — and they don’t have to pay a cent to those injured by their vaccines.
Adult patients and children being given vaccines take all the risk, and themselves pay for the damages awarded to those injured or killed by government licensed and mandated vaccines. Many Americans do not even realize this vaccine court exists because DHHS does not publicize the existence of a federal vaccine injury compensation program and few VICP claims are ever disclosed, let alone publicized. The desire for secrecy on the part of public health officials is understandable.
If Americans were routinely informed of the vaccine injury and death claims being processed through the VICP, concern about the safety of vaccines would undoubtedly rise exponentially. Even without publicity, VICP claims are rapidly rising. As noted by investigative journalist Sharyl Attkisson in December 2015:5
“Since January of 2014, the number of flu vaccine cases conceded by the government is more than double the previous eight years combined … Also on the rise is the number of vaccine injury cases the government has ‘conceded:’ up 55 percent in a little over one year.”
National Childhood Vaccine Injury Act Should Be Repealed
Two years ago, the National Vaccine Information Center (NVIC) called for the repeal of civil liability protection provided to drug companies under the 1986 National Childhood Vaccine Injury Act6 and a return to full product liability for vaccine manufacturers. At the time, NVIC co-founder and president Barbara Loe Fisher said:7
“The 1986 National Childhood Vaccine Injury Act is a failed experiment in tort reform and should be repealed so vaccine manufacturers are accountable and liable in a civil court of law for product safety. The federal vaccine injury compensation program Congress created under that law has become a drug company stockholder’s dream and a parent’s worst nightmare.”
Nothing has changed in the two years since. The VICP remains irreparably broken. A vast majority of the injury compensation claims paid out by the vaccine court today are not even for children suffering lifelong injuries or death from childhood vaccines that they are mandated to get to attend daycare or school — they’re for adults (often health care workers) suffering serious side effects from the influenza vaccine.
On March 31, 2017, vaccine safety and choice advocates, including the NVIC, Moms Across America, Organic Consumers Association, Focus for Health, Vaccine Injury Awareness League and other grassroots consumer groups, who are protesting the too-cozy relationship between the pharmaceutical and chemical industries and government, gathered for a “Revolution for Truth” rally8 in Washington D.C.
The groups are urging President Trump to examine the VICP’s many problems, and create an independent agency to monitor and evaluate vaccine safety.
Forced Vaccinations Are Unethical and Dangerous
Last year, Gretchen DuBeau, executive and legal director for Alliance for Natural Health USA, wrote:9
“When health officials assure us that almost all children should receive the full schedule of vaccinations, you would think that rigorous safety testing has repeatedly proven vaccines, their ingredients, and the CDC schedule to be completely safe. The sobering truth is, however, that this safety testing has been conspicuously lacking and in many cases simply has not been done.
Until these extremely serious safety concerns are adequately addressed, it is unethical — and very possibly dangerous — to force children to be vaccinated.
Take aluminum, for example, which has been added to vaccines since the 1930s to help jolt the body’s immune system into action. Aluminum is a well-documented neurotoxin linked with Alzheimer’s disease, epilepsy, asthma, hyperactivity and Down’s syndrome. Despite these dangers, adequate clinical research proving aluminum adjuvants to be safe has never been done.”
Indeed, it is the lack of evidence of safety that concerns most parents who decide to delay or forgo one or more vaccinations for their children. Most of these parents have children who had serious reactions to vaccination or know someone who became chronically ill after vaccination. That experience prompted them to do independent research and not just get their children vaccinated without fully understanding the risks.
But rather than conducting the necessary methodologically sound scientific research to settle these uncertainties, the vaccine industry has chosen to join with medical trade associations funded by pharmaceutical companies and public health agencies and simply push for forced vaccination laws that eliminate vaccine exemptions instead. And why not? Forced vaccination guarantees maximum profits since there are no repercussions should their vaccines turn out to do more harm than good.
Aside from the lack of long-term safety studies of vaccines that take into account real-world usage parameters such as giving multiple vaccinations on the same day, there’s yet another safety issue that is routinely swept under the rug — that of vaccine recalls. In fact, vaccines have the highest number of recalls of any drug!
According to a 2012 report by business intelligence experts GBI Research,10 vaccines “fail to meet safety standards.” Between 2007 and 2010, 14 recalls for vaccines were made, for reasons such as:
- Serious adverse events
- Labeling errors
- Quality defects (reduced levels of potency, presence of contaminants, such as glass particles)
- Manufacturing defects
Coincidence Claims Falter as Vaccine Damage Becomes Commonplace
As time goes on and vaccine injuries multiply, claims of “coincidence” are getting increasingly more preposterous and harder to swallow. Today, vaccine injuries are becoming like cancer — the prevalence is so high, most people know someone who has suffered a serious side effect from a vaccine. Statistics revealing compelling parallels between vaccination rates and disease rates add to the mounting skepticism.
As noted in a January 2017 report by WJTV12 News,11 Mississippi has one of the highest vaccination rates in the U.S. It also has one of the highest autism rates. Coincidence? No one knows, but in the absence of firm proof either way, many parents are renewing their call for the legal right to make voluntary decisions about which vaccines their child should receive and if or when they should be given.
The same scenario is playing out in other states across the nation. The numbers of children suffering with chronic illness and disability, including autism spectrum disorders, are increasing. The numbers of children and adults who have experienced serious vaccine reactions are also increasing. As a result, first-hand experience with vaccine reactions now include many physicians, celebrities and politicians, as well.
Academy award-winning actor Robert De Niro, for example, has recently gone on the public record questioning vaccine safety and the reported link between vaccines and autism.
He has a child who developed autism following vaccination. Rick Rollens, former Secretary of the California State Senate, as well as retired U.S. Rep. Dan Burton (R-Ind.) are two examples of individuals who worked for government and publicly shared their personal experiences of family members who had serious vaccine reactions and developed autism.
President Trump has also made public statements in which he questioned the potential connection between vaccination and autism and the safety of one-size-fits-all vaccine policies.
All of them have been strongly criticized for attempting to open up discussions about vaccine risk issues, which just goes to show that no one is above ridicule should they dare to question the safety of vaccines. The trend cannot hold forever, though. At a certain point, the coincidence theory collapses, and that’s what we’re starting to see now.
Unfortunately, many people don’t wake up and get involved until it’s personal and, in recent years, we’ve seen a growing number of influential people describe their personal experiences with vaccine reactions. The question is, how bad does it have to get before public concerns about vaccine safety get a fair hearing?