An Untenable Status Quo—Conflicts of Interest Must Go

By the Children’s Health Defense Team

As the Children’s Health Defense eBook, Conflicts of Interest Undermine Children’s Health, tries to make clear, the passage of the National Childhood Vaccine Injury Act (NCVIA) in 1986 was a watershed event that emboldened vaccine manufacturers and their public- and private-sector accomplices—notably the Centers for Disease Control and Prevention (CDC)—to systematically hide the serious damage caused by vaccines. In addition to making a mockery of pre-licensing safety testing and post-marketing surveillance, these entities have regularly manipulated (or destroyed) data to exaggerate both the benefits and effectiveness of vaccination. Manufacturers have also used their money and power to subordinate the mainstream media, medical journals and front groups, making it possible to publish and broadcast deceptive studies that whitewash questions inconvenient to the financial bottom line.

From multiple standpoints—not least of which is children’s dismal state of health—the status quo is untenable. Three of the most urgent steps to be taken include repealing the NCVIA, eliminating vaccine mandates (making both childhood and adult vaccination voluntary) and addressing conflicts of interest by establishing a fully transparent and independent vaccine safety commission.

Repeal the NCVIA

The NCVIA has been an unmitigated disaster. As New York University law professor Mary Holland has written, the Act’s passage has allowed the government and vaccine manufacturers to ride roughshod over three important legal protections:

• Free and informed consent to an invasive medical procedure
• Accurate and complete information about vaccine ingredients and possible side effects
• The right to sue manufacturers and medical practitioners directly in the event of injury.

According to Holland, the absence of these legal protections for vaccination is “striking” compared to “almost all other medical interventions.”

The legal protections are interrelated. For example, an individual cannot exercise truly informed consent unless he or she has access to full and unbiased information. Recognizing this, one provision of the NCVIA was a mandate for the CDC to develop (and health care providers to distribute) patient education materials about vaccine risks and benefits. However, not only has the CDC repeatedly dumbed down the materials in a variety of ways, but research suggests that many doctors do not comply with the legal requirement to hand out (much less discuss) them. Instead, providers and the media continue to blandly assure the public that vaccine injuries are a “one in a million” event, never mentioning that 99% of vaccine injuries go unreported. Under the circumstances, no meaningful assessment of vaccine risks is possible.

Research shows that by eliminating consumers’ ability to sue, the NCVIA has had a tangibly negative effect on vaccine safety. After an extensive analysis of nationwide and state-level U.S. data, a researcher reported in 2017 that vaccines licensed after NCVIA’s passage were associated with “a significantly higher incidence of adverse events” compared to vaccines licensed prior to the law’s passage. The researcher concluded that “product safety deteriorates when consumers are no longer able to sue manufacturers.” Repealing the NCVIA and reinstating product liability would not solve all of the ethical problems that permeate the pharmaceutical industry’s business culture, but it could curtail the “free-for-all” environment that has prevailed since 1986 and might incentivize manufacturers to treat vaccines in the same way as drugs and put safety on somewhat of a more even footing with profits.

NCVIA repeal would also draw greater attention to the exorbitant financial stress experienced by vaccine-injured individuals and families. The National Vaccine Injury Compensation Program (NVICP) not only has “failed to compensate generously” but, far more often than not, does not compensate at all. Holland and others have identified many factors contributing to the low levels of vaccine injury compensation, including:

• Public and medical ignorance about vaccine injury
• Ignorance about the NVICP
• The NVICP’s three-year statute of limitations
• An adversarial litigation context
• Inconsistent judgments by the vaccine court
• Delayed and below-market compensation for attorneys and medical experts
• Medical expert fear of “anti-vaccine” stigma
• Unavailability of medical documentation
• An impossibly high burden of proof for most types of injuries

Despite the NCVIA legislation’s focus on childhood vaccines, 71% of compensated claims have been for vaccine injuries in adults, leaving many vaccine-injured children and their families out in the financial cold. In the only study ever to explore petitioners’ experiences with the NVICP, petitioners described the vaccine injury claims process as “confusing, time-consuming, too lengthy, and traumatic,” and about half rated the award amount as “inadequate to cover past and future medical care.” In short, whereas Congress marketed the NVICP as a speedy, non-adversarial, no-fault compensation mechanism that would free the injured of the need to prove vaccine-related causation, it has turned out to be slow and litigious, requiring proof of causation for more than 90% of claims filed. As one individual familiar with the system has stated, “even when cases are fairly simple, ‘the government will fight.’”

Eliminate Vaccine Mandates

Medical informed consent—“the primary paradigm for protecting the legal rights of patients and guiding the ethical practice of medicine”—is meaningless if an individual does not have the option of “determin[ing] what shall be done with his body” and declining a given medical intervention. Vaccination in the U.S. makes a mockery of this ethical principle because vaccines are increasingly compulsory—for school attendance, health care employment, participation in the military, immigration and more.

Vaccine proponents and medical ethicists have proven themselves willing to blur the lines of informed consent in multiple ways, arguing, for example, that “adolescent autonomy” and improved vaccine uptake justify eliminating parental consent requirements for HPV vaccination in preteens and adolescents. This argument prevailed in California in 2011 when then-Governor Jerry Brown signed a bill allowing minors as young as 12 to consent on their own to the HPV and hepatitis B vaccines.

Compulsory vaccination policies in the U.S. have not had positive results. Instead, they have given rise to a wide variety of unintended and undesirable consequences, including unnecessary vaccinations that have wreaked havoc with children’s normal immune system development; unsafe vaccines; inadequate warnings about vaccine risks; conflicts of interest in national vaccine policy; insufficient compensation for the vaccine-injured; and an alarming decline in children’s health and well-being.

Research shows that there is no relationship “between mandatory vaccination and rates of childhood immunization.” Rather than trying to corral the small percentage of individuals who are currently eligible for medical, religious or philosophical vaccine exemptions into a “vaccinate-at-all-costs” police-state dragnet, the U.S. should recommit to international principles of informed consent and make all vaccines voluntary. Unfortunately, there is an accelerating trend toward greater use of mandates and “other legal instruments” not only in the U.S. but also in Europe. There, some experts have cautioned that legal sanctions are being applied by “those who want to punish a country—or, in the case of vaccinations, a citizen—that deviates from the norm.” These experts warn that mandates often have a high cost in the court of public opinion.

Address Conflicts of Interest

Conflicts of interest—far from being occasional aberrations—are part and parcel of the U.S. vaccination program, and they have had a decisive and negative impact on children’s health. Over the years since the passage of the NCVIA, a handful of courageous legislators—troubled by the “cozy corporate alliances” that exist between industry and captured federal regulators—have put forth pleas for an objective and non-conflicted vaccine safety commission to investigate and resolve safety problems. Some researchers, likewise, have called for an independent National Vaccine Safety Board—separate from the CDC or any branch of government—to “ensure optimal vaccine safety.” A 2006 editorial in Nature concurred that in light of waning public confidence in vaccine safety, a strong case could be made for establishing a “well-resourced independent national agency that commands the trust of both the government and the public in matters of health protection.”

In early 2017, Children’s Health Defense Chairman Robert F. Kennedy, Jr. discussed the creation of a vaccine safety commission with then-president-elect Trump and also met with high-level National Institutes of Health (NIH) and Food and Drug Administration (FDA) officials. The Trump administration chose not to pursue the idea, despite the glaring need to introduce transparency to the U.S. vaccination program.

In March, 2018, Children’s Health Defense took to the halls of Congress and shared its multi-pronged Vaccine Safety Project with every member, arguing (among other actions) for the need to:

• subject vaccines to a scientifically rigorous approval process,
• require reporting of vaccine adverse events,
• ensure that all parties involved with federal vaccine approvals and recommendations are free from conflicts of interest and
• support fully informed consent and individual rights to refuse vaccination.

Hopefully, concerned parents, health care professionals, legislators and others will lend their voices to these reasonable requests so that conflicts of interest can be abolished once and for all, and sound science—rather than deep pockets—can form the basis of vaccine policy-making.

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