From Children's Health Defense
This article represents Part I of a two-part series on mumps. Part II will delve further into the mumps vaccine’s spillover effects on fertility.
By Robert F. Kennedy, Jr., Chairman of the Board, Children’s Health Defense
Across the country, frenzied legislators are responding to the pharmaceutical industry’s orchestrated fear campaign around measles by seeking to impose further mandating of Merck’s measles, mumps and rubella (MMR) vaccine. Although ongoing mumps outbreaks involving thousands of at-risk adolescents and young adults completely dwarf the number of measles cases, no one is covering the mumps story—because it will expose the fact that Merck has been in court for over eight years due to scientists blowing the whistle on Merck’s fabrication and falsification of the effectiveness of the mumps component of its MMR vaccine. Instead of punishing Merck for its chicanery, legislatures are rewarding the company by making it impossible to refuse Merck’s profitable vaccine, subjecting a generation of American children to the risk of serious complications from mumps infection at an age that nature never intended.
When younger children experience mumps, the virus is relatively harmless; infected children often exhibit no symptoms. When mumps strikes adolescents or adults, on the other hand, the infection can cause far more serious adverse effects, including inflammation of various organs (brain, pancreas, ovaries and testicles)—as well as damage to male fertility.
Inflammation of one or both testicles (a condition called orchitis) occurs in approximately one in three post-pubertal men who get mumps and can contribute to sperm defects and subfertility as well as impairing the function of cells that produce testosterone. An estimated 30% to 87% of men with bilateral orchitis induced by mumps experience full-blown infertility—a major cause for concern given the significant declines in male fertility observed over the past several decades. Thus, it appears that Merck’s vaccine, instead of protecting children, not only delays onset of disease to later age cohorts but has the potential to cause serious and permanent injury.
Merck and mumps vaccines
Let’s look at a quick history of mumps and MMR vaccination in the United States. The Food and Drug Administration (FDA) licensed Merck’s initial mumps-only vaccine in 1967. In 1971, Merckintroduced its first combination MMR vaccine, followed by the MMR-II vaccine in 1978 (which repurposed the rubella component) and the MMR-plus-varicella (MMRV) ProQuad vaccine in 2005. Since the initial 1967 vaccine, Merck has enjoyed a unique monopoly position in the U.S. market for mumps and MMR vaccines, with combined sales of MMR-II and ProQuad bringing in over $720 million in 2014 alone. Merck consistently places in the top five pharmaceutical companies globally, and the market valued its stocks at a seven-year high as of late 2018.… Merck has willfully and illegally maintained its monopoly through ongoing manipulation and by representing to the public and government agencies a falsely inflated efficacy rate for its Mumps Vaccine.
In order to score the lucrative MMR monopoly, Merck needed to satisfy the FDA that all three components of the combination vaccine could achieve 95% efficacy, but the mumps portion was bedeviling. In fact, as alleged in a lawsuit filed by two senior Merck scientists in 2010 under the False Claims Act, the company has known since the late 1990s that the mumps component of the MMR is “far less” than 95% effective. A 2005 study published in Vaccine estimated the effectiveness of mumps vaccination to be closer to 69%, and the authors noted that their results were consistent with other studies.
The two whistleblowers assert in the lawsuit—which is reportedly headed to trial sometime this year—that Merck has “willfully and illegally maintained its monopoly” through “ongoing manipulation” and by “representing to the public and government agencies a falsely inflated efficacy rate for its Mumps Vaccine.” Specifically, the two scientists claim that Merck executives ordered them to use “rigged” methodologies, including taking antibodies from rabbits and adding them to human blood vials, in order to gull regulators into assuming an antibody response robust and durable enough to merit licensing. When those “enhanced” tactics did not achieve Merck’s “fabricated [95%] efficacy rate,” the whistleblowers allege, the company resorted to simply falsifying the test data and engaging in other fraudulent activities.The fact that we have mumps showing up in highly immunized populations likely reflects something about the effectiveness of the vaccine.
Unprotected adolescents and young adults
The poor performance of the MMR’s mumps component and the doubtful “durability” of mumps-specific immunity following vaccination are of concern. In fact, we are already living with the legacy of this badly flawed vaccine. Rather than protecting a generation of American children from mumps infection in childhood, the vaccine has merely postponed the onset of the virus to older age groups, putting them at much greater risk. Researchers confirm an increase in the median age of mumps patients, a surge in the size and number of mumps outbreaks in highly vaccinated populations and higher rates of complications—including orchitis.
Across the country, galloping mumps epidemics have been ravishing an older generation of vaccinated individuals. The Centers for Disease Control and Prevention (CDC) reported 150 outbreaks (9,200 cases) in the year and a half from January 2016 to June 2017, affecting “schools, universities, athletics teams and facilities, church groups, workplaces, and large parties and events.”
Over the past several years, the number of college campuses reporting mumps outbreaks has exploded—at institutions ranging from Harvard and Temple to Syracuse, Louisiana State and Indiana universities. At the University of Missouri, which in 2016 reported 193 mumps cases on campus, the health center director reported not having seen anything like it “in her 31 years at the school.” Commenting on the fact that all of the afflicted students had had the requisite two doses of MMR, she noted,
“The fact that we have mumps showing up in highly immunized populations likely reflects something about the effectiveness of the vaccine.”
The mumps virus has also made a “comeback” in other settings where younger adults congregate. For example, a naval ship deployed to the Persian Gulf, the USS Fort McHenry, has been unable to come ashore since early January because of a mumps contagion that has devastated its crew—even though the military vaccinates all personnel against the virus and despite the Navy having immediately subjected the crew in question to another MMR booster. News accounts have declined to comment on mumps complications but describe the quarantine as “a morale killer” for crew members who are accustomed to having monthly port calls. Infection control protocols stipulate that the Navy cannot declare the situation “under control” until “50 days after the last affected service member recovers.”
Endangering rather than protecting youth
All of these cohorts are part of an age group that should never get mumps. As Children’s Health Defense recently noted, whereas “flares of illness in vaccinated groups should prompt some serious questions about vaccine failure,” legislators and government agencies “are displaying a dangerous indifference to vaccination’s unintended consequences.” Dancing to puppet strings manipulated by Merck, legislators across the country are trying to foist even harsher MMR mandates on unwilling Americans, dooming a generation of children to the serious risks of late-onset mumps infections.
Part II
It has been about five decades since the U.S. Food and Drug Administration (FDA) approved Merck’s first mumps vaccine. The company began launching combination MMR (measles, mumps and rubella) vaccines in the 1970s. Coincidentally—or not—an infertility crisis has been brewing over roughly the same time period, with dramatic declines in sperm counts and record-lowfertility levels. However, few investigators seem interested in assessing whether mumps outbreaks in highly vaccinated populations of teens and young adults could be having long-termeffects on fertility or other health indicators.
As described in Part I, childhood MMR vaccination has been an unmitigated disaster where mumps is concerned, deferring mumps infection to older ages and leaving adolescents and young adults vulnerable to serious reproductive complications. Public health reports show that the vast majority of mumps cases and outbreaks occur in youth who have been fully vaccinatedwith the prescribed two-dose MMR series, supporting a hypothesis of “waning immunity after the second dose.” FDA and Centers for Disease Control and Prevention (CDC) officials even admitthat mumps outbreaks in the post-vaccination era “typically involve young adults,” and that vaccination is failing to protect those who are college-age and above.
Myopically, many vaccine experts have called for a third MMR dose—or even “booster dosing throughout adulthood”—even though the FDA’s and CDC’s own research shows that MMR boosters in college-age youth barely last one year. As alleged in whistleblower lawsuits wending their way through the courts over the past eight years, Merck presented the FDA with a “falsely inflated efficacy rate” for the MMR’s mumps component, using animal antibodies and other fraudulent tactics to fool FDA—and the public—into believing that the vaccine was effective.
When infection arises after puberty, however, mumps is no laughing matter, presenting an increased risk of complications such as hearing loss, encephalitis and inflammation of the reproductive organs.
Mumps after puberty is no laughing matter
Around the time that the first mumps vaccine came on the market, the 1967 children’s classic The Great Brain humorously depicted mumps infection in childhood as a mere nuisance. The book’s young protagonist goes out of his way to intentionally infect himself with mumps so that he can beat his two brothers to the recovery finish line—and he experiences no adverse consequences other than his siblings’ annoyance.
When infection arises after puberty, however, mumps is no laughing matter, presenting an increased risk of complications such as hearing loss, encephalitis and inflammation of the reproductive organs. About one in three postpubertal men with mumps develops orchitis(inflammation of the testes), which can damage sperm, affect testosterone production and contribute to subfertility and infertility. During a mumps outbreak in England in the mid-2000s, mumps orchitis accounted for 42% of all hospitalized mumps cases; the researchers attributed this outcome—which was the most common reason for hospitalization—to “the high attack rates in adolescents and young adults” that occurred “despite high coverage with two-dose MMR.” An analysis of a 2006 mumps outbreak in the U.S. reported that male patients were over three times more likely than female patients to experience complications, “due primarily to orchitis.”
An estimated 5% to 10% of postpubertal women will develop oophoritis (swelling of the ovaries) following mumps infection. Oophoritis is associated with premature menopause and infertility, but mumps-related oophoritis has garnered little notice.
Mumps infections are often asymptomatic or produce nonspecific symptoms such as fever, while cases of orchitis may present with no other mumps symptoms. Nonetheless, public health officials advise clinicians that orchitis is an instant cue to test for mumps virus, and testing often reveals elevated mumps antibodies. In a case report of MMR failure, British clinicians isolated a novel genetic strain of mumps virus from the patient’s semen two weeks after the onset of orchitis and found mumps RNA in the semen 40 days later; they also noted “the appearance of anti-sperm antibodies,” with “potential long-term adverse effects on the patient’s fertility.”
In 2017, researchers who reviewed 185 studies conducted in Western nations found that sperm counts had plummeted by 50% to 60% between 1973 and 2011—an average decrease of 1.4% annually. Commenting on this work, one analyst estimated that 20% to 30% of young men in Europe and North America have sperm concentrations associated with a reduced ability to father a child. Given estimates that as much as 40% of reproductive problems have to do with the male partner, there is agreement on the importance of “finding and eliminating [the] hidden culprits in the environment” that most researchers believe are to blame.
An estimated 5% to 10% of postpubertal women will develop oophoritis (swelling of the ovaries) following mumps infection. Oophoritis is associated with premature menopause and infertility, but mumps-related oophoritis has garnered little notice.
MMR’s and MMRV’s potential to impair fertility never studied
Merck has not evaluated either of its two MMR vaccines—the MMR-II and the MMR-plus-varicella (MMRV) vaccine—for their potential to impair fertility. Whether such testing would unearth direct effects on fertility (as appears to be possible with HPV vaccination in women) is thus unknown. However, mumps vaccination undeniably increases reproductive-age individuals’ risk of mumps infection and, in the process, increases the risk of fertility-altering complications. These facts alone should be attracting far more attention.
Unfortunately, because clinicians already tend to underdiagnose mumps infection and underestimate mumps complications, it is likely that they are failing to recognize possible vaccine-induced reproductive health consequences of mumps infection in their adolescent and young adult patients. In one university outbreak, “most physicians…did not suspect mumps,” and even when they became aware of the outbreak, “diagnosing mumps was not always straightforward.” Moreover, although differentiating between vaccine strains of mumps virus and wild types could provide valuable information, few clinicians have the capacity or inclination to perform testing of this type. A Japanese study of cerebrospinal fluid and saliva from patients with mumps complications found vaccine strain in nearly all of the samples and noted the information’s importance in helping determine whether the complications were vaccine-related.
Those who have sought to understand mumps vaccines’ poor performance point to a mixture of explanatory factors. These include waning immunity, the high population density and close quarters encountered in settings such as college campuses, incomplete vaccine-induced immunity to wild virus as well as viral evolution such that “the vaccine triggers a less potent reaction against today’s mumps viruses than those of 50 years ago.” However, some also quietly admit that individuals with “mild vaccine-modified disease” could be perpetuating the chain of transmission. This latter point ought to be raising questions about the logic and wisdom of administering further rounds of MMR boosters during outbreaks while ignoring the problems created by the doses already given.
… some individuals respond poorly to mumps vaccination and vaccine-induced antibody levels correlate poorly with protection from mumps infection, irrespective of the number of additional doses of mumps-containing vaccine they receive.
Most scientists appear to be either resigned to ongoing mumps outbreaks in vaccinated populations or actually accept periodic outbreaks as the cost of doing business. Publications by FDA and CDC researchers reveal these agencies’ awareness that some individuals respond poorly to mumps vaccination and that vaccine-induced antibody levels correlate poorly with protection from mumps infection, “irrespective of the number of additional doses of mumps-containing vaccine they receive.” Considering the effects on fertility, the generally abysmal track record of mumps vaccination and Merck’s fraudulent claims about efficacy, it is hard to fathom medical and public health experts’ complacency about current mumps vaccines and vaccine policies.