Beneath all the bombast of the current political climate, there is one issue that has gained relatively little national attention but is of great concern to public health advocates – a reenergized attack on vaccine safety. Longtime vaccine safety critic Robert F. Kennedy Jr. and actor Robert DeNiro recently offered a $100,000 prize to anyone that can prove vaccines are safe.
Specifically, the challenge cited is to “find a peer-reviewed scientific study demonstrating that thimerosal is safe in the amounts contained in vaccines currently being administered to American children and pregnant women.”1
The FDA concluded in a 1999 review of the issue that there was “no evidence of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions.”2 Nevertheless, the use of the mercury-containing preservative has been largely phased out, with the FDA reporting that the vast majority of vaccines for children 6 years of age or younger marketed in the U.S. contain no thimerosal or only trace amounts.
Earlier this year, Kennedy was reportedly in discussions with then president-elect Donald Trump about possibly forming a vaccine panel of some sort, but at this writing it was unclear whether that will be pursued.
The mere mention of forming such a panel alarmed public health officials, says William Schaffner MD, one of the most well known and respected vaccination advocates in the nation.
“[Kennedy] visited the president elect, came out and made that statement, and then the [Trump] transition team walked that back so that’s in flux at the present time.” says Schaffner, a professor of preventive medicine at Vanderbilt University in Nashville. “Many of us are concerned that the integrity of vaccines would be challenged by such a presidential commission. Much of the concerns about vaccines are unfounded, and particularly this myth that autism is related to vaccination. As a scientific and public health question, that is now settled. There is no association between autism and vaccines.”
In a statement issued on Trump’s Jan. 20 inauguration day, the Pediatric Infectious Disease Society expressed similar sentiments. Citing the thorough review process already in place by the CDC’s Advisory Committee on Immunization Practices (ACIP), the society said it “stands behind the overwhelming scientific evidence showing that vaccines do not cause autism. It is dangerous to perpetuate this myth and doing so is likely to result in harm to our children from vaccine-preventable diseases. Statements by those claiming a connection between vaccines and autism with no scientific basis should be recognized as fraudulent and misleading. ….[We] call on our government leaders to recognize the overwhelming evidence showing the outstanding safety of childhood vaccines and to avoid the temptation to equate anecdotes with scientific evidence.
We further call on our government leaders to avoid providing a hint of legitimacy to myths such as this one for which there is no scientific evidence. To do so will unnecessarily endanger the lives of American children.”
Debate Controversy
The vociferous nature of these reactions should be viewed in light of a September 16, 2015 Republican presidential debate, when then candidate Trump linked vaccines to autism by citing the amount of immunizations given in a short period to babies and young children. The comments were roundly condemned by the medical community, with the American Academy of Pediatrics (AAP) calling them both false and dangerous.
“Claims that vaccines are linked to autism, or are unsafe when administered according to the recommended schedule have been disproven by a robust body of medical literature. It is dangerous to public health to suggest otherwise,” the AAP said in a statement after the debate. “There is no ‘alternative’ immunization schedule. Delaying vaccines only leaves a child at risk of disease for a longer period of time; it does not make vaccinating safer.”
Similarly, an IOM report that reviewed more than 1,000 studies found no link between vaccines and autism.3 A 2015 study published in the Journal of the American Medical Association found no link between MMR vaccine and autism after looking at 95,000 children from birth to at least five years of age.4 There was no link even among children already at higher risk for autism due to an existing diagnosis in an older sibling.
The vaccine safety issue was originally seized on by some to explain the perceived dramatic increase in autism over the last few decades. The theory gained traction after publication of a later-retracted study in Lancet that falsely suggested MMR vaccine administration triggered the onset of autism in children.5 However, it appears that much of the autism increase has been due to changing definitions — “diagnostic substitution” — that have increased the number of intellectual disabilities defined as autism.
This surveillance artifact accounted for a 64% increase in autism diagnosis from 2000-2010, researchers concluded.6 Despite the preponderance of evidence, the anti-vaccine message has had an effect, particularly in the uptake of the MMR vaccine for measles, mumps and rubella. A 2015 study estimated that some 9 million U.S. children were susceptible to measles, a disease that had been virtually eradicated in the U.S. through routine vaccination.7 While these unvaccinated children run the risk of a serious or complicated infection, they also pose a transmission threat to infants too young to be vaccinated and others who are contraindicated for vaccination or can mount little immune response even if given MMR.
A Case of Amnesia
While the $100,000 offer grabbed a few headlines, it is the possible formation of some kind committee or panel linked to the Trump Administration that is the primary concern, says William B. Miller, Jr., MD, a physician and author who has been publically critical of these recent developments. He currently serves as a scientific advisor to OmniBiome Therapeutics, which includes research on the utility of vaccines and other agents to protect the the maternal immune system. Hospital Infection Control & Prevention asked Miller to elaborate on his concerns in the following interview.
HIC: It’s unclear at this point whether a vaccine panel will be formed by the Trump administration, but in any case, you argue that it is unnecessary.
Miller: “We actually have an established global panel that looks at these things carefully based on well-done research and carefully considered scientific analysis. We don’t need another panel on this subject. It’s not merely redundant and therefore a complete waste of money, but it will become a platform for the vast majority of antivaxers out there, who bring to this argument issues of their own life tragedies.”
HIC: This subject has been certainly driven by those kind of stories, by people and celebrities that have suffered autism in their families.
Miller: “They must be respected for that. I really want this to be understood. There’s no one that is anti-vaccination that wants to do harm. They are people of good will. They want to do the best thing for their children, for themselves and others. I would emphasize further that behind every person who is antivaccination there is a story of personal tragedy or an impression that somehow vaccination has impacted them in a hurtful manner. The problem is, you can’t do science like that. That is the antithesis of everything we hold responsible science to be. The power of narratives is like a sermon – it is better if it contains anecdotes that tug at your heart. In the same way if you going to fight for a cause you bring people forward to give testimony. People who you can identify as an average individual, but that is no way to do things [scientifically]. It’s the power of the personal narrative. That narrative power is substantial in the era of the internet especially when it is a celebrity that can gain a platform.”
HIC: This issue keeps recurring despite studies and comprehensive reviews.
Miller: “There is literature that can be used as ammunition, which simply says this should be explored. The fact that thimerosal was voluntarily withdrawn has become something in and of itself, a rallying cry that there was something tainted about it the first place, which is untrue. The idea was the methyl mercury at allowable amounts is difficult to gauge so let’s not allow any if we can. It is true that how you make the vaccine and what you use for stabilizers has changed over time. It is true that vaccinations can have adverse effects. We recognize there are straight-forward allergic reactions particularly egg products that are part of the manufacturing stabilization process. So it’s not as if there is absolutely 100% safety. There is a risk to everything you ever do in life. But the interesting about thing is that thimerosal and mercury have basically been removed from vaccines down to the most tiny trace imaginable for a decade or more. And the incidence of autism is rising. The cause and effect was not only established in the first place, but now there is an indication that there was never any linkage because the incidence is continuing to change despite the fact that the additives that the objection is based upon has been removed.”
HIC: You also make the argument that the nation has some collective “amnesia” about what life was like before vaccines were developed.
Miller: “Yes. In the history of medical milestones one would cite antibiotics, anesthesia, asepsis, but far and away at the top of the list would be vaccinations. Vaccination has had the most beneficial powerful effect for humanity than anything that a human being has ever devised in its continuous fight against an agitating, outward environment. We live in a continuous [exposure] to communicable diseases. In another era it was common to have families of 12 and nine died in childhood. Smallpox wiped out millions during the plague of Antonine in 180 AD. It was probably the single greatest contributor to the accelerated decline of the Roman Empire. A very high percentage of those who survived smallpox were blinded by it.
People don’t know these things in anymore. It’s complete amnesia. Smallpox, measles, typhus – all of the things we have vaccines against effectively wiped out the Aztec and Inca Empires. Ninety percent of the population was killed by infectious diseases. People forget polio. I’m old enough to remember having a girl in my class – walking with braces. Who wants to bring this back? Though they are trying to do a ‘good’ thing, the antivaxers couldn’t be doing a worse thing for themselves and their community.”
REFERENCES
- Feldman, K. Robert F. Kennedy Jr. and Robert De Niro are offering $100,000 to anyone who can provide proof that vaccines are safe. New York Daily News Feb. 15, 2017: http://nydn.us/2ks3Sx3
- FDA. Thimerosal in Vaccines Questions and Answers. July 31, 2105: http://bit.ly/2mYDFUi
- IOM. Adverse Effects of Vaccines: Evidence and Causality. August 25, 2011: http://bit.ly/1YnWZrn
- Jain A, Marshall J, Buikema A, et al. Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism. JAMA 2015;313(15):1534-1540.
- Editors of The Lancet: Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 2010;375:445.
- Polyak A, Kubina RM, Girirajan S. Comorbidity of intellectual disability confounds ascertainment of autism: implications for genetic diagnosis. Am J Med Genet B Neuropsychiatr Genet 2015;168(7):600-608.
- Bednarczyk R, Orenstein WA, Omer, S. Estimating the Number of Measles-susceptible Children in the United States Using the NIS-Teen. Poster 1866. IDWeek Oct. 7-11 2015. San Diego, CA
Beneath all the bombast of the current political climate, there is one issue that has gained relatively little national attention but is of great concern to public health advocates – a reenergized attack on vaccine safety. Longtime vaccine safety critic Robert F. Kennedy Jr. and actor Robert DeNiro recently offered a $100,000 prize to anyone that can prove vaccines are safe.
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