RFK Jr. Cherry-Picks and Misuses Data on Aluminum-Containing Vaccines

A ample Danish study recently provided reassurance that aluminum-containing vaccines are not associated with accrued rates of chronic wellness conditions successful children, including autism. But Health and Human Services Secretary Robert F. Kennedy Jr. misrepresented the study’s findings, claiming that the paper’s supplementary information “shows calamitous grounds of harm.”

The study, published connected July 15 successful Annals of Internal Medicine, drew attention due to the fact that of its ample size and rigorous methods. Anti-vaccine activists, however, rapidly seized connected it to claim that it was flawed, peculiarly aft the diary mistakenly uploaded an earlier mentation of the supplementary data.

Kennedy declared successful an X post past period that the authors utilized a “long parade of statistical artifices” to “achieve their deceptive results,” incorrectly alleging that the survey really showed an relation betwixt vaccines and autism. He linked to an article with his byline connected TrialSiteNews, which consisted of a database of criticisms of the survey peppered with unfounded accusations connected the researchers’ motives. It called for the diary to “immediately retract this severely flawed study.”

The journal, however, defended the study. Dr. Christine Laine, the editor-in-chief of Annals, wrote successful an editor’s effect that the diary recovered the survey “to beryllium among the strongest probe presently available” connected the taxable and that determination was nary ground for retraction.

Small amounts of aluminum are used in some vaccines arsenic adjuvants that boost the immune effect and marque vaccines much effective. Among those that incorporate aluminum are vaccines that protect against hepatitis A and B, HPV, and diphtheria and tetanus. There is nary aluminum successful the measles, mumps and rubella vaccine, which has been subject to unfounded claims astir autism successful the past.

Aluminum has been used as a vaccine adjuvant since the 1920s. The quantities of aluminum successful vaccines correspond an “extremely debased hazard to infants,” researchers from the U.S. Food and Drug Administration have concluded. Despite this, aluminum has agelong been a target of anti-vaccine groups.

In the lawsuit of the Danish aluminum study, Kennedy dismissed the results of the paper’s main analysis. It recovered nary narration betwixt aluminum vulnerability from vaccines and an elevated hazard of dozens of conditions, including autism. Instead, helium zeroed successful connected results connected autism successful 2 of the paper’s 15 supplementary figures and tables, which helium claimed connected X were “a devastating indictment of aluminum-containing vaccines straight contradicting the published study’s conclusions.” 

As we volition explain, Kennedy’s mentation of these figures is unwarranted. For one, statisticians cognize that if a insubstantial makes a ample fig of comparisons, immoderate results are expected to beryllium statistically important by accidental alone. It is inappropriate to absorption connected a azygous effect oregon subset of results portion ignoring their context.

Kennedy “is doing utmost cherry-picking of the results helium likes and ignoring and dismissing each of the results helium doesn’t like,” Jeffrey S. Morris, manager of the part of biostatistics astatine the University of Pennsylvania’s Perelman School of Medicine, told us.

For another, Kennedy highlighted an investigation that the authors of the insubstantial and different experts said should not beryllium utilized to find whether aluminum successful vaccines causes wellness conditions.

“In short, Kennedy is cherry-picking a fragile secondary investigation that is explicitly disclaimed by the study’s authors and misrepresenting it arsenic a refutation of the main findings,” vaccinologist Helen Petousis-Harris of the University of Auckland told america successful an email. “It’s a classical misuse of supplementary data.” She called the supplementary results Kennedy highlighted a “statistical blip, not a bombshell.”

Anders Hviid, caput of the epidemiology probe section astatine the Statens Serum Institut successful Denmark, agreed that Kennedy’s mentation of his team’s survey amounted to cherry-picking. “Our results showed that expanding vulnerability to aluminum from vaccines was not associated with expanding risks of a wide scope of aboriginal puerility wellness conditions successful Denmark,” helium told america successful an email.

Kennedy’s statements followed a pattern familiar to those who person tracked the secretary’s past of unfounded claims connected vaccines and autism. Historically, Kennedy has ignored oregon attempted to discredit well-done scientific studies that have failed to show a nexus betwixt autism and vaccination. His criticisms are often accompanied by inflammatory connection and unfounded claims about researchers’ motivations. At the aforesaid time, helium has zeroed successful connected results that helium claims amusement an association, elevating flawed studies and highlighting decades-old unpublished statistic that weren’t borne retired by aboriginal analysis.

HHS did not reply to a petition for comment.

‘The Cherry-Pick of All Cherry-Picks‘

Denmark’s universal, publically funded wellness attraction strategy and elaborate record-keeping allow researchers to survey the narration betwixt aesculapian attraction and wellness outcomes. Hviid and his colleagues analyzed vaccination and wellness information connected much than 1.2 cardinal children who were calved successful the state implicit the people of astir 2 decades. As the Danish vaccine docket changed implicit time, the magnitude of aluminum successful recommended vaccines besides changed, allowing the researchers to measure whether each further milligram of aluminum vulnerability had immoderate narration to chronic disease.

In their superior analysis, the researchers found no nexus betwixt the magnitude of aluminum the children received via vaccination and elevated rates of 50 chronic conditions. These conditions included asthma and allergic diseases, autoimmune diseases, and neurodevelopmental conditions. This past radical of conditions included attention-deficit/hyperactivity upset and 5 autism-related diagnoses.

“The main findings, based connected coagulated methods and each the data, showed no accrued risk,” Petousis-Harris said (emphasis is hers).

Rather than highlighting these reassuring results, Kennedy focused connected a supplemental fig showing a hardly statistically important summation successful 1 autism-related diagnosis successful a azygous acceptable of children.

“The information amusement a statistically important 67% accrued hazard of Asperger’s syndrome per 1 mg summation successful aluminum vulnerability among children calved betwixt 2007 and 2018,” Kennedy wrote on X. (In the U.S., Asperger’s syndrome is nary longer a circumstantial diagnosis. The information was folded into the autism spectrum upset diagnosis successful 2013 successful the 5th variation of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders.)

“That is the cherry-pick of each cherry-picks,” Morris said. 

The fig was portion of a bid of analyses meant to look astatine the information successful assorted ways and spot if the superior results held up — and clasp up they did, successful astir each cases. There was nary accrued hazard of immoderate different autism-related diagnosis successful the investigation erstwhile dividing the children by commencement year, nor of Asperger’s successful children calved successful the archetypal 10 years of the study, though Kennedy failed to notation these results. Nor was determination an accrued hazard of autism, including Asperger’s, successful the superior investigation nor successful a assortment of different analyses, specified arsenic erstwhile the researchers divided the children by enactment oregon changed the magnitude of clip they followed the children’s health.

“You can’t conscionable spell done pages and pages and pages of tables and prime 1 small 1 retired that you similar and disregard each the others,” Morris said.

Moreover, the Asperger’s statistic Kennedy highlighted was imprecise owed to the tiny fig of children diagnosed with Asperger’s successful the applicable clip period. Statistics often travel with confidence intervals, which are calculations of the scope of answers 1 would expect to travel up with if repeating a survey galore times. The smaller the radical of radical researchers are looking at, the wider the assurance interval tends to beryllium and the little precise the result.

In this case, determination were only 51 children diagnosed with Asperger’s with commencement years successful the 10-year play the researchers were looking at. The estimate of a 67% accrued hazard of Asperger’s came with a assurance interval indicating a 95% accidental that the existent reply was determination betwixt a 1% accrued hazard and a 177% accrued risk. That is to say, determination was a large woody of imprecision in the result.

Furthermore, Morris explained, the likelihood of getting a statistically important effect by random accidental unsocial increases the much comparisons a idiosyncratic makes. Typically, researchers see a effect statistically important if there’s conscionable a 5% probability that the effect occurred owed to accidental alone. But Morris said that this means that adjacent successful a concern successful which determination is nary quality betwixt the groups being compared, 1 tin expect 1 retired of each 20 comparisons to springiness a mendacious positive. Thus, it is not astonishing that idiosyncratic looking for a peculiar effect successful a insubstantial with galore comparisons volition find validation for their view, adjacent if the wide information bash not enactment it. 

“Several comments noted marginally important associations with immoderate neurodevelopmental conditions observed successful secondary analyses reported successful the supplement,” diary editor-in-chief Laine wrote in her editor’s response. “Secondary analyses explored implicit 540 comparisons, truthful it is expected that immoderate are apt to beryllium statistically important by accidental alone. The editors hold with the authors’ attack of basing conclusions connected the superior adjusted analyses that are the astir rigorous and valid.”

Unwarranted Interpretation of Data

Kennedy besides highlighted a 2nd acceptable of results in the paper’s supplementary materials to warrant his assertion that the insubstantial showed an accrued hazard of autism. But Hviid told america that not lone was this acceptable of results cherry-picked, but it shouldn’t person been utilized to gully conclusions connected causes of illness successful the archetypal place.

The fig — which divides kids’ aluminum vulnerability into highest, mean and lowest categories — was “not introduced to trial the proposal of the paper, and it surely does not ‘overrule’ the main insubstantial and its approach,” Hviid said.

Kennedy, however, portrayed the results arsenic showing an accrued hazard of autism. “Compared to the mean vulnerability group, for each 10,000 children successful the highest aluminum vulnerability cohort, determination were: 9.7 much cases of neurodevelopmental disorder, 4.5 much cases of autistic disorder, and 8.7 much cases of the broader class of autism spectrum disorder,” Kennedy said on X.

Petousis-Harris said that this supplementary fig does not bespeak an accrued hazard of neurodevelopmental disorders owed to aluminum exposure, contrary to Kennedy’s claim. “The authors and diary exertion some said these supplementary results are invalid for causal mentation and shouldn’t beryllium utilized the mode Kennedy is utilizing them,” she said. “This is similar trying to triumph a shot crippled by picking up the shot and moving it into the goal—after the referee said ‘no hands allowed.’”

Hviid and his colleagues said successful an Aug. 11 follow-up remark connected the insubstantial that their superior investigation “is the astir due for evaluating the hypothesis, and we basal by our interpretation.”

In their superior analysis, the authors adjusted for commencement twelvemonth due to the fact that commencement twelvemonth tin independently power both vaccine aluminum vulnerability and a child’s likelihood of getting a definite diagnosis. For instance, successful the lawsuit of autism, we cognize that diagnoses person accrued implicit the years astatine slightest successful portion owed to changes in screening, broadening diagnostic criteria and accrued awareness.

In the fig Kennedy highlighted, it was intolerable for radical calved anterior to 2002 to autumn into the highest class of aluminum exposure, the researchers explained. This violates a statistical rule called the positivity assumption, they said. It’s not valid successful this benignant of investigation to comparison groups of radical if determination is an important adaptable for which determination are nary radical represented successful 1 of the groups.

“If you’re going to set for a confounding origin that affects the 3 groups, successful this case, you request to person that origin astatine slightest represented somewhat successful each of the 3 groups oregon you can’t close for it,” Morris explained.

“[Y]ou can’t comparison apples to oranges if you don’t person immoderate oranges successful the aforesaid basket,” Petousis-Harris said, adding that erstwhile the positivity presumption is violated, “estimated associations tin go highly unstable and misleading.”

When the researchers did the aforesaid investigation lone looking astatine children calved successful 2002 and beyond — a radical successful which each 3 aluminum vulnerability levels were represented — they did not find important differences successful autism diagnoses betwixt groups.

Mixing Criticism With Unfounded Accusations

In a acquainted pattern, Kennedy mixed reasonable and unreasonable critiques of the survey with unfounded and inflammatory claims astir the survey authors’ motives.

All technological studies person immoderate limitations. The Danish survey was observational, meaning that it analyzed information connected wellness without manipulating the exposures, arsenic would beryllium done successful a randomized, controlled trial. It would beryllium unethical to randomly delegate radical to person oregon not person puerility vaccines known to beryllium effective. But successful observational studies, determination is ever the anticipation that radical successful antithetic groups stock immoderate trait that influences the outcome.

To springiness 1 example, Kennedy brought up the thought that, by adjusting for wide practitioner visits earlier property 2, the researchers obscured signals of harm successful children whose doc visits were caused by vaccine injuries. Researchers set for wellness attraction visits because patients who sojourn their doc much are besides much apt to successfully get a diagnosis for their wellness problems. Responding to that criticism, Hviid and his colleagues shared an investigation successful an Aug. 11 comment showing that determination remained nary important nexus betwixt aluminum and harms adjacent aft taking distant this adjustment.

Many of Kennedy’s points are “reasonable to rise and discuss” Hviid wrote in a effect published Aug. 3 connected the aforesaid website. But Kennedy’s criticisms are “couched successful needlessly vitriolic rhetoric,” Hviid wrote.

For 1 thing, Kennedy mischaracterized the past of the study’s supplementary materials. “Fierce disapproval from the technological assemblage has present forced the authors to merchandise their supplementary data, which shows calamitous grounds of harm,” he wrote on X.

We person not been “‘forced’ to merchandise anything,” Hviid told america successful an email. The insubstantial was published with supplementary materials from the beginning, but the diary “put up an older mentation of the supplementary materials arsenic a elemental mistake,” Hviid said, and the diary corrected this 2 days later.

Laine, the journal’s exertion successful chief, explained that Hviid and his co-authors had recovered during the reappraisal process that the the wellness information they had utilized was missing immoderate information from psychiatry hospitals, truthful they redid their investigation utilizing the further data. But diary unit accidentally uploaded out-of-date supplementary materials, alternatively than the updated materials the authors had submitted. “Annals published the close supplement arsenic soon arsenic the mistake was detected,” Laine said. “This was a elemental administrative mistake and reflects nary malfeasance connected the portion of the authors oregon Annals.”

Kennedy besides repeatedly implied immoderate sick intent oregon fiscal motive connected the portion of Hviid and his co-authors, contempt a deficiency of grounds for these accusations. He opened his article, for instance, by calling the survey “so profoundly flawed it functions not arsenic subject but arsenic a deceitful propaganda stunt by the pharmaceutical industry.” He went connected to say, again without evidence, that the “architects of this survey meticulously designed it not to find harm.”

“The assertion that we person designed this survey to find nary relation tin beryllium easy refuted,” Hviid wrote successful his response. He explained that the plan was based connected a 2022 U.S. study — funded by the Centers for Disease Control and Prevention, with immoderate bureau co-authors — that showed a imaginable nexus betwixt aluminum-containing vaccines and asthma. Kennedy had mentioned this survey successful his TrialSiteNews nonfiction arsenic the azygous citation supporting his assertion that determination are “mountains of contrary lit documenting the neurotoxicity of aluminum and its relation with autoimmune and allergic diseases.”

The U.S. researchers asked Hviid to effort to replicate the uncovering connected asthma and aluminum utilizing the Danish data, and his squad did not find a nexus betwixt aluminum-containing vaccines and asthma. He presented these results astatine a 2023 gathering of the CDC’s vaccine advisory committee. For the caller paper, Hviid and his colleagues utilized the aforesaid basal attack to measure a wider scope of chronic conditions.

As justification for his unfounded assertion that the survey results were driven by pharmaceutical companies, Kennedy wrote that 3 survey authors, including Hviid, “are affiliated with Denmark’s Statens Serum Institut (SSI), a government-owned vaccine institution that develops a fig of aluminum-containing vaccines.”

In fact, arsenic Hviid explained successful his Aug. 3 response to Kennedy, Statens Serum Institute — which translates to State Serum Institute — is not a company, but alternatively is Denmark’s “national communicable diseases power institute,” and does not presently nutrient oregon merchantability immoderate vaccines. 

Previously, the institute manufactured aluminum-containing and different vaccines, including those protecting against diphtheria, tetanus and whooping cough, arsenic good arsenic polio and tuberculosis. But the Danish authorities eventually decided that manufacturing vaccines was “no longer indispensable nor profitable astatine a nationalist level” and sold its vaccine accumulation capabilities successful 2017.

Kennedy also wrote in his nonfiction that Hviid’s backing from the Novo Nordisk Foundation “call into question the study’s independence.” The Novo Nordisk Foundation is simply a nonprofit enactment that controls the Danish pharmaceutical institution Novo Nordisk, known for its diabetes and anti-obesity drugs.

Hviid pointed out in his effect to Kennedy that his grants from the instauration are unrelated to the vaccine probe and were alternatively related to bosom nonaccomplishment and instrumentality learning. “The Novo Nordisk Foundation is 1 of the biggest supporters of wellness subject successful Denmark,” helium added.

In addition, Kennedy claimed that due to the fact that the researchers did not stock the earthy Danish wellness attraction data, the survey was lacking successful “transparency and reproducibility.” But arsenic Hviid explained, sharing the earthy information is intolerable owed to regulations protecting delicate wellness information of Danish individuals.

Petousis-Harris disputed the conception that the work was lacking successful transparency. “I would spell truthful acold arsenic to accidental the authors person been exceedingly transparent successful responding to critics, which stands successful stark opposition to the mischaracterisation of the information by Kennedy. Like immoderate study, this 1 is not without limitations,” she said, pointing to her own blog post that discussed immoderate of them. “However, it is an important publication to the assemblage of evidence.”

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