Understand the problem

JUNE 11, 2019

Vaccine Rhetoric vs. Reality—Keeping Vaccination’s Unflattering Track Record Secret

By the Children’s Health Defense Team

[Note: This is Part VI in a series of articles adapted from the second Children’s Health Defense eBook: Conflicts of Interest Undermine Children’s Health. The first eBook, The Sickest Generation: The Facts Behind the Children’s Health Crisis and Why It Needs to End, described how children’s health began to worsen dramatically in the late 1980s following fateful changes in the childhood vaccine schedule.]

 

A concerted and “heavy-handed” effort is under way to censor information that contradicts the oversimplified sound bites put forth by public health agencies and the media about vaccines. However, while brazen, in-your-face censorship—and attacks on health freedom—have ratcheted up to an unprecedented degree,  officialdom’s wish to keep vaccination’s unflattering track record out of the public eye is nothing new.

There is a chasm between vaccine rhetoric and reality for most if not all vaccines, but four vaccines—varicella (chickenpox), rotavirus, human papillomavirus (HPV) and pertussis-containing vaccines—offer especially instructive before-and-after case studies. Analysis of the U.S. experience with these vaccines raises important questions. First, why did the Food and Drug Administration (FDA) race to approve—and why does the Centers for Disease Control and Prevention (CDC) heavily promote—vaccines such as varicella and rotavirus when there is little public health justification for them? Second, why are federal agencies ignoring the many serious risks that have surfaced in the vaccines’ wake—problems unheard of before the vaccines’ introduction?

With the rollout of mass varicella vaccination, shingles started cropping up to an unprecedented extent in both children and adults, eliminating boosting for adults and shifting downward the average age at which shingles occurs.

Varicella and rotavirus vaccines

The rationale for the varicella and rotavirus vaccines was dubious from the start. In the U.S. and other wealthy countries, varicella and rotavirus were nearly universal and mostly benign childhood infections; in those settings, the pre-vaccine impact of the two conditions was largely measured in terms of “healthcare costs, missed daycare, and loss of time from work for parents/guardians” rather than in terms of serious illness or mortality.

Childhood chickenpox infections served an important purpose for all, conferring lifelong immunity to infected children while boosting adult immunity to the related shingles (herpes zoster) virus. With the rollout of mass varicella vaccination, shingles started cropping up to an unprecedented extent in both children and adults, eliminating boosting for adults and shifting downward the average age at which shingles occurs. Vaccine waning also began increasing young adults’ risk for varicella outbreaks and complications later in life, presenting “perverse public health implications.” Meanwhile, the CDC and its local public health partners worked hard to conceal these unwanted chickenpox vaccine outcomes from the public.

Rotavirus vaccines have had a similarly checkered history. Soon after their introduction in the U.S., reports emerged of a substantially increased risk in infants of an otherwise rare bowel complication called intussusception. The FDA knew about the problem during the prelicensing regulatory review process but ignored it. Although the agency subsequently withdrew its approval for one of the problematic rotavirus vaccines, it was not until after an estimated 500,000 children received at least one million doses. The FDA never explained the “precise mechanism” by which the discontinued vaccine caused intussusception.

Two rotavirus vaccines that display the same intussusception risks are still on the U.S. market. Both are contaminated with foreign DNA from porcine viruses capable of causing severe immunodeficiency in pigs. Had the presence of these “adventitious agents” been discovered prior to vaccine licensure, the FDA probably would have been forced to shelve the vaccines, yet they remain on the vaccine schedule to this day.

The speed with which the FDA gave them [HPV vaccines Gardasil and Gardasil-9] the go-ahead—despite obvious red flags regarding their safety—illustrates the insincerity of the agency’s assertions that its vaccine approval process is committed to minimizing risks.

HPV vaccines

The HPV vaccines Gardasil and Gardasil-9 (manufactured by Merck) represent perhaps an even more compelling case studyof risk-laden vaccines that should have attracted strong up-front regulatory scrutiny—but didn’t. The speed with which the FDA gave them the go-ahead—despite obvious red flags regarding their safety—illustrates the insincerity of the agency’s assertions that its vaccine approval process is committed to minimizing risks.

The FDA not only gave the quadrivalent Gardasil a free pass but has repeatedly reapproved it and the nine-valent Gardasil-9 for wider use. (Gardasil-9 is a newer formulation that contains more than twice the amount of neurotoxic aluminum adjuvant as Gardasil.) In 2009, the FDA also okayed GlaxoSmithKline’s HPV vaccine, Cervarix, but Merck’s FDA-facilitated stranglehold on the market prompted the company to withdraw Cervarix from the U.S. in 2016. Merck is now aggressively expanding its Gardasil “franchise” into other countries, generating unprecedented worldwide demand, while continuing to “rev up” U.S. sales.

Since 2006, the FDA’s Gardasil-related decisions have included:

  • 2006: Granting fast-tracked approval for the original quadrivalent Gardasil vaccine (girls and women aged 9 to 26 years)
  • 2009: Approving Gardasil’s use in boys and men (ages 9-26)
  • 2014: Approving Gardasil-9 (girls ages 9-26, boys ages 9-15)
  • 2015: Approving Gardasil-9 for boys ages 16-26
  • 2018: Approving Gardasil-9 for older women and men (ages 27-45)

An eight-month investigation by Slate identified numerous troubling aspects of the clinical trials that encouraged U.S. and European regulators to approve Gardasil. The Slate reporter also criticized regulators for allowing “unreliable methods to be used to test the vaccine’s safety.” These included Merck’s use of “a convoluted method” that made it difficult to objectively evaluate and report side effects; its failure to document “symptom severity, duration, outcome, or overall seriousness”; restriction of adverse event reporting to just 14 days following each injection; and reliance on the subjective opinion of clinical trial investigators regarding “whether or not to report any medical problem as an adverse event.” Not infrequently, clinical trial participants who shared complaints of debilitating symptoms with trial investigators were dismissed with the response, “This is not the kind of side effects we see with this vaccine.”

The author of the Slate investigation reported:

Experts I talked to were baffled by the way Merck handled safety data in its trials. According to…a professor…who studies side effects, letting investigators judge whether adverse events should be reported is “not a very safe method of doing things, because it allows bias to creep in.” …Of the short follow-up…,“It’s not going to pick up serious long-term issues, which is a pity. Presumably, the regulators believe that the vaccine is so safe that they don’t need to worry beyond 14 days.”

Two years after Gardasil’s initial approval, Judicial Watch pronounced it a “large-scale public health experiment.” Post-licensure studies carried out since then confirm that HPV vaccines have grave risks, including impaired fertility, demyelinating disease, chronic limb pain, circulatory abnormalities and autoimmune illness, to name just some of the disabilities reported in the aftermath of HPV vaccines’ introduction. Overall, the “rate of reported serious adverse reactions (including deaths) from HPV vaccination” is many times higher than the cervical cancer mortality rate.

Recent data suggest that HPV vaccines may be increasing cervical cancer risks.

In a February 2019 letter to the CDC, Children’s Health Defense Chairman Robert F. Kennedy, Jr. noted, “During Gardasil’s clinical trials, an extraordinary 49.5% of the subjects receiving Gardasil reported serious medical conditions within seven months of the start of the clinical trials. Because Merck did not use a true placebo in its clinical trials, its researchers were able to dismiss these injuries as sad coincidences.” A current civil case brought on behalf of a 24-year-old who has suffered from systemic autoimmune dysregulation since receiving her third Gardasil vaccine at age 16 alleges that Merck “committed fraud during its clinical trials and then failed to warn [vaccine recipients] about the high risks and meager benefits of the vaccine.” The trial’s legal team is benefiting from the support of an “A-team” of plaintiffs’ law firms and attorneys, including Kennedy, Jr.

Recent data suggest that HPV vaccines may be increasingcervical cancer risks. A 2017 study out of Australia—which has heavily promoted routine HPV vaccination since 2007—reported an increased risk of difficult-to-detect malignant cervical lesionsamong the HPV-vaccinated. In all countries where HPV vaccination coverage is high, including Australia, official cancer registries show “an increase in the incidence of invasive cervical cancer” in the vaccinated age groups. In England, “2016 national statistics showed a worrying and substantial increase in the rate of cervical cancer…at ages 20-24”—the first HPV-vaccinated cohort.

The proper decision would be to take HPV vaccines off the market, but the FDA and CDC continue to look the other way. Both agencies’ unwavering support for Gardasil has clearly helped Merck’s commercial bottom line, so much so that the CDC director at the time of Gardasil’s approval (Julie Gerberding) went on to be appointed president of Merck’s profitable vaccine division (worth $5 billion globally) in 2009. The agencies’ willingness to aggressively promote HPV vaccination despite its readily apparent dangers illustrates a “public health flimflam” of the first order. Before the U.S. introduction of HPV vaccination, a decades-long pattern of declining cervical cancer rates was already well underway, thanks to routine cervical cancer screening. HPV vaccines have never even been proven to prevent cervical cancer. In 2016, researchers admitted that they would be unable to ascertain HPV vaccines’ long-term efficacy for “at least another 15-20 years.”

Officials also seem to have little interest in modern evidence documenting many vaccines’ inability to provide the promised protection, even when vaccine coverage is widespread.

Pertussis-containing vaccines

Alongside their many misplaced claims about various vaccines’ rationale and safety record, the FDA and CDC—as echo chambers for the vaccine industry—also have misinformed the public about vaccine effectiveness. Back in 1899, doctor William Bailey (vaccination enthusiast and member of the State Board of Health in Louisville, Kentucky) was more honest, cautioning that “nothing is gained by claiming too much” about vaccine-induced immunity and stating that “the degree of immunity may vary with time and circumstance”—presaging the troublesome modern phenomena of vaccine failure and waning immunity. In the present day, officials are only too willing to “claim too much,” conveniently ignoring historical evidence that reductions in infectious disease had little to do with vaccines and far more to do with improvements in sanitation and nutrition. Officials also seem to have little interest in modern evidencedocumenting many vaccines’ inability to provide the promised protection, even when vaccine coverage is widespread.

The acellular version of pertussis (whooping cough)—a component of U.S. vaccines such as DTaP and Tdap—is one of the vaccines noted for its abysmal effectiveness. The vaccine is supposed to protect against the respiratory infection caused by Bordetella pertussis. Instead, according to recent studies, pertussis is making a “surprising” comeback; between 1990 and 2005, pertussis epidemics increased in the U.S. “in both size and frequency,” and over half of all cases occurred in highly vaccinated adolescents aged 10 to 20 years old. In fact, not only is pertussis at its highest level since the mid-1950s, but, according to CDC researchers, it is showing signs of being vaccine-resistant. The CDC researchers also note “substantial heterogeneity among vaccine recipients in terms of the durability of the protection they receive.”

… the researchers concluded in 2017 that all currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis … 

West Africa has used the DTP vaccine since the 1980s—formulated with a whole-cell pertussis component instead of acellular pertussis—and it has an even more horrifying safety and effectiveness record than its acellular counterparts. Research published in 2017 by a prestigious team of international scientists and led by vaccinology expert Dr. Peter Aaby found that DTP vaccination had a negative effect on child survival, with fivefold higher mortality in young DTP-vaccinated infants (ages three to five months) compared to as-yet-unvaccinated infants. When the researchers published results in 2018 for slightly older DTP-vaccinated children (ages six months to three years), they continued to observe more than double the risk of death as similarly situated unvaccinated children. Explaining that vaccines can increase susceptibility to other infections, the researchers concluded in 2017 that “all currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis” and added in 2018 that “all studies of the introduction of DTP have found increased overall mortality.”

Learning from history

Efforts to counter the official vaccine narrative with evidence about negative consequences date back to the days of smallpox. A doctor practicing in the 1870s observed that smallpox mortality doubled (from roughly 7% to 15%) after adoption of smallpox vaccination. During an outbreak in 1871 and 1872, this doctor stated, faith in vaccination received a “rude…shock” when “[e]very country in Europe was invaded with a severity greater than had ever been witnessed during the three preceding centuries.” The doctor also noted that “many vaccinated persons in almost every place were attacked by small-pox before any unvaccinated persons took the disease.” In this individual’s estimation, these facts were “sufficient to overthrow the entire theory of the protective efficacy of vaccination.”

In the present era, federal agencies continue to tout difficult-to-justify but money-spinning vaccines as beneficial, even in the face of substantial evidence to the contrary. Now, more than ever, it is important to illuminate the risks and downsides that public health agencies do not want us to know about.

 

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