Tuesday, February 27, 2018

False Balance in the Media

Just the Vax is recommending a post by Joel Harrison, PhD, MPH has published on Science Based Medicine. Enjoy.

[Note that the full article can be accessed by clicking here and a downloadable PDF version is available by clicking on the note at the top of the article]

The So-Called Vaccine Debate, False Balance in the Mass Media & The Risk to Public Health

Executive Summary

by Joel A. Harrison, PhD, MPH

February 26, 2018

The San Diego Union-Tribune (UT) recently published two opinion pieces on vaccine mandates, responding to California Senate Bill 277 which removed the “personal belief” exemption to vaccine requirements for children entering into day care, elementary or secondary schools. The bill was passed by the California Legislature in 2015:

Mark Sawyer, MD is a professor of clinical pediatrics in the Division of Infectious Diseases in the UCSD Medical School. Terry Roark is the advocacy director in California for the nonprofit National Vaccine Information Center.

Each piece was given equal length, giving the impression that each side represented a legitimate position, creating a false balance. In all fairness, the UT has posted articles and editorials on other occasions that clearly supported vaccines and the science behind them, e.g., “In a win for science and for student safety, school vaccination rates are the highest they have been in California in at least 15 years” (The San Diego Union-Tribune Editorial Board, 2017). The problem is that people often have short term memories, may not have read the previous pro-vaccine articles in the UT, or, seeing two articles, were influenced more by the one than the other.

As will be shown in this paper, the article by Terry Roark is full of inaccuracies, falsehoods, and misrepresentations, cultivating readers to form an opinion that is invalid. Like Roark, the vast majority of antivaccinationists lack the basic understanding of the science underlying vaccines, view the world as all or none, subscribe to paranoid conspiracy theories, and their certainty of the rightness of their opinion clearly reflects research that shows once people form opinions, they seldom change them and, remarkably, when confronted with evidence that they are wrong, they often embrace their point of view even more tenaciously (Tavris, 2007). Some of this can be attributed to the Dunning-Kruger effect, which posits that people often fail to grasp their level of competence (or more to the point, incompetence), which precludes their ability to form credible opinions.

Summary and Conclusion

In publishing Roark’s opinion piece, in my opinion, The San Diego Union-Tribune is guilty of creating a false balance. My intent is NOT to single out the UT as this is a problem belonging to our mass media in general. However, as the UT is my hometown newspaper, it provided an excellent example.

As I’ve demonstrated in this article, not one point made by Roark is valid. The underlying premise she is coming from is based on a lack of the basics of science, thus, a bogus opinion on vaccines, a lack of understanding of the economics of vaccine production, and a misleading quote, taken out of context, from a Supreme Court decision. Her affiliation with the National Vaccine Information Center and its Co-Founder and President, Barbara Loe Fisher, as shown by Fischer’s statement, leaves little doubt that besides a lack of scientific knowledge, antivaccinationists suffer from paranoid delusions of conspiracy theories, project their own, often vicious, attacks on the integrity and honesty of those promoting vaccines, including threatening statements, and see the world in terms of the Nirvana Fallacy (for more on Barbara Loe Fisher as the main spokesperson for the National Vaccine Information Center, see Orac, 2017). Attacks on the integrity and honesty of scientists says more about the attackers than the scientists. Such attacks indicate that antivaccinationists are incapable of systematically and validly using microbiology, immunology, epidemiology, biostatistics, and the history of infectious diseases to make their case and display, in my opinion, a crass lack of integrity and decency, basically anything and everything goes to influence people’s opinions, regardless of how unscientific, illogical, and including threats and character assassination.

Given that The San Diego Union-Tribune has, on the whole, been supportive of vaccines, it would behoove them, as well as our mass media in general, to re-evaluate their choice of opinion pieces and even letters that clearly do not reflect, have NO validity, on other issues as well. The UT’s policy regarding Letters to the Editor, “It is also our policy to attempt to publish letters supporting or opposing a particular issue in a ratio reflecting the number received on each side,” when one side is clearly taking an unscientific, invalid position, promotes false balance and is a disservice to readers (The San Diego Union Tribune. Letters and Commentaries).

Joel A. Harrison (2018 Feb). The So-Called Vaccine Debate, False Balance in the Mass Media, and the Risk to Public Health: Terry Roark’s Opinion Piece in the San Diego Union-Tribune (Oct 5, 2017) , “Exemptions should be option for parents”. Science-Based Medicine.

Joel A. Harrison, PhD, MPH is a retired epidemiologist who has been writing articles over the past years supporting vaccinations for Every Child By Two, an excellent non-profit founded in 1991. Every Child By Two has changed to Vaccinate Your Family, expanding its mission to include vaccines for people of all ages. You can find Executive Summaries of his previous ECBT articles that hyperlink to the complete articles as well as his brief biography on the archived ECBT Expert Commentaries page. Dr. Harrison has studied and worked in several countries, including Sweden (where he earned his doctorate) and Canada (where he earned a Masters degree). Having experienced both the Swedish socialized health care system and the Canadian non-profit single-payer system, over the past 30 years he has devoted considerable time to studying health economics and health care systems, concluding that, though the Swedish system is excellent, given American culture, he believes that a non-profit single-payer system would be best option for the United States. Dr. Harrison is a long time member of Physicians for a National Health Program.

Thursday, November 30, 2017

Christopher Exley has Become the New Face of the Anti-Vaxx Aluminium Grift

A new study by Mold et al. Aluminium in brain tissue in autism is not Exley's (corresponding author) first foray into aluminium as the cause of name-that-disorder by any stretch.  His publications vilify aluminium for a sundry of unrelated observations such as impaired sperm counts and quality, Alzheimer's Disease, "vaccine-induced" macrophagic myofaciitis and chronic fatigue syndrome along with fellow aluminium grifter Gherardi, breast cancer and of course vaccines.

The study Aluminium in brain tissue in autism is problematic from the start.  As Orac and The Blood-Brain Barrier Scientist note, Christopher Exley sits on the editorial board of the “Journal of Trace Elements in Medicine and Biology“ where the study was published.  The study also had an extremely rapid submission to acceptance time frame which was 26 October for submission, 21 November for a submitted revision, 23 November for acceptance and 26 November for online publication.  The sole funding source for this study was the Child Medical Safety Research Institute (CMSRI) which is a Dwoskin family foundation.  CMSRI is the funding source for the duo of Shaw and Tomljenovic to the tune of $900,000.00.  Clare Dwoskin is very very anti-vaccine which is evidenced by her statement to journalist John Stossel:
What his daughter went through is NOTHING compared to what the families of autistic children go through every day of their lives. No disease can match this record of human devastation. Vaccines are a holocaust of poison on our children’s brains and immune systems. Shame on you all.
More on what kind of "research" the Dwoskins finance can be found here and here.  The Dwoskins' latest study (prior to this one) with Christopher Shaw as the corresponding author was retracted due to image manipulation and dodgy methods.

While these issues individually don't disqualify the merits of a study, taken together they do cast serious doubt on the scientific rigour, review and impartiality of the study.  More importantly, the methods and results are the issues which ultimately render this study completely meaningless.

The thrust of this study is laid out in the abstract and introduction that state:
Human exposure to the environmental toxin aluminium has been linked, if tentatively, to autism spectrum disorder.
Paediatric vaccines that include an aluminium adjuvant are an indirect measure of infant exposure to aluminium and their burgeoning use has been directly correlated with increasing prevalence of ASD [11].
No it hasn't and is based upon some cherry-picked, weak studies.  The authors obtained five samples of brain tissue from people with confirmed autism spectrum disorder (ASD) for aluminium measurement.  They also obtained ten paraffin-embedded brain tissue samples from ASD individuals for fluorescent microscopy.

There were no controls.  Yes you read that correctly.  Not a single control for any aspect of this study; I'll elaborate.  The authors state:
Total aluminium was measured in each sample by transversely heated graphite furnace atomic absorption spectrometry (TH GFAAS) using matrix-matched standards and an established analytical programme alongside previously validated quality assurance data [13].
The "established analytical programme alongside previously validated quality assurance data" is their own protocol which is from these two studies, Brain burdens of aluminum, iron, and copper and their relationships with amyloid-β pathology in 60 human brains and The Identification of Aluminum in Human Brain Tissue Using Lumogallion and Fluorescence Microscopy.  I don't think validation means what they think it means.  This was internally-validated and not a recognised method for TH GFAAS by having been actually validated independently.

In the recent study two technical things (among many) stand out for the recently published "Aluminium in brain tissue in autism", first there was no mention of blanks used.  Granted it was an abbreviated description given the protracted version was explained in "Brain burdens of aluminum, iron and copper and their relationships with amyloid-β pathology in 60 human brains" (House, Exley et al. 2012), however there is no mention of an aluminium blank used to correct for contamination in either the body of the text nor in the description of Table 1 (Mold, Exley et al. 2017) where the values for aluminium content appear.  But this does appear in the cited study in both the body of the text and the description for it's Table 3 (House, Exley et al. 2012) aluminium content of brain samples.  It's worth mentioning that in the cited study (House, Exley et al. 2012), several samples have negative values and a high degree of intra-sample variation.  This is a problem with with their validation and they weakened this further by not including blanks in the autism study (Mold, Exley et al. 2017) as evidenced by the higher degree of intra-sample variation.

The second technical issue was the use of mean in the aluminium autism study.  Exley stated in his own cited brain aluminium study that due to non-normal distribution of intra-sample values, median with standard deviation was calculated.  This is correct but this was not done for the autism aluminium study, instead they used mean with standard deviation which skewed the means much higher because the outlier values were captured.  These values are further meaningless since the standard deviations are higher than the mean values for 3 of the four lobes sampled.
The mean (SD) aluminium content across all 5 individuals for each lobe were 3.82(5.42), 2.30(2.00), 2.79(4.05) and 3.82(5.17) μg/g dry wt. for the occipital, frontal, temporal and parietal lobes respectively.
Another huge problem for this study is both lack of controls and their own scale of pathology:
Previous measurements of brain aluminium, including our 60 brain study [15], have allowed us to define loose categories of brain aluminium content beginning with ≤1.00 μg/g dry wt. as pathologically benign (as opposed to ‘normal’). Approximately 40% of tissues (24/59) had an aluminium content considered as pathologically-concerning (≥2.00 μg/g dry wt.) while approximately 67% of these tissues had an aluminium content considered as pathologically- significant (≥3.00 μg/g dry wt.). The brains of all 5 individuals had at least one tissue with a pathologically-significant content of aluminium.
They cited The Identification of Aluminum in Human Brain Tissue Using Lumogallion and Fluorescence Microscopy (Mirza, Exley 2016) but it was not developed from samples of 60 brains; it was developed from multiple samples of one brain.  They rated the wildly variable observed aluminium levels in the Mold, Exley et al. 2017 study using a scale they developed in Mirza, Exley 2016 based on one single brain donation.  The authors must have a lot of contempt for their target audience and benefactors or are woefully inept to try and pass this stratification off as valid.  But more importantly, the results are meaningless because they did not include any controls, nor did they include any information on medical and dietary history nor causes of deaths of the individuals whose samples were donated.

The microscopy isn't any better.  There is no validation of the stain specificity nor control for contamination.  The Blood-Brain Barrier Scientist discusses the problems with the microscopy in detail.  Futhermore, they use Photoshop for visualising and enhancing images:
The subsequent merging of fluorescence and bright-field channels was achieved using Photoshop (Adobe Systems Inc. US).
This is not standard practice, in fact it's rather amateurish.  There are dedicated software packages available for fluorescent microscopes that track image capture and enhancements.  There is also no randomisation of microscopy sections nor blinding of the reader.  Presumably (or should be) there are several images taken and randomly selected for results discussion.  This was not done so for all we know, images are cherry-picked for maximum effect.  The fact that the microscopy suddenly had ten different samples (instead of the five previously noted) begs the question of IRB approval not to mention their Table S1 does not appear in the published study.

They make very far-reaching conclusions about their findings but fail to qualify any clinical relevance.  No histology was done so actual pathology of tissues samples is lacking.  The discussion is loaded with supposition with no evidence to support their claims.
A limitation of our study is the small number of cases that were available to study and the limited availability of tissue. Regarding the latter, having access to only 1g of frozen tissue and just 3 serial sections of fixed tissue per lobe would normally be perceived as a significant limitation. Certainly if we had not identified any significant deposits of aluminium in such a small (the average brain weighs between 1500 and 2000g) sample of brain tissue then such a finding would be equivocal. However, the fact that we found aluminium in every sample of brain tissue, frozen or fixed, does suggest very strongly that individuals with a diagnosis of ASD have extraordinarily high levels of aluminium in their brain tissue and that this aluminium is pre-eminently associated with non-neuronal cells including microglia and other inflammatory monocytes.
No the actual limitations of this study are the utter lack of controls, validation and rigour at every step of the way.  Non ASD people and with no pathology are going to also have aluminium deposits in their brain tissue.  Brain tissue banks are precious resources for neuroscience investigators.  It's a gross violation of the scientific method to be wasted on rubbish studies such as this to satisfy a rich matron with a hatred for vaccines.

ETA 12.18.17: Buzzfeed just reported that scientists they spoke with, who have relevant experience have rejected this study due to the problems with the methodology listed here and on other blogs.   Additionally, Christopher Exley has a substantial conflict of interest which he failed to report.  It turns out he is a benefactor and shill for SilicaWaters.com who sell ACILIS by Spritzer, a product that is touted by Exley to remove aluminium from our bodies.  SilicaWaters reports that 10% of their sales is donated to Exley's research into the benefits of drinking silica-rich water.

Monday, April 17, 2017

Andrew Wakefield is the Anti-Vaxx Gift That Keeps Giving

The Minnesota Department of Health has confirmed that at least eight children have measles.  They are all between the ages of 1 year and 4 years old and NONE have been vaccinated against measles although they are age-eligible.  Seven of the eight children belong to the large Somali community in Hennepin County and six have been hospitalised.  There may be more cases given the low MMR vaccine uptake among those in that community and only one case could be traced to a contact.

Andrew Wakefield, professional fraud made at least three trips to the Minnesota Somali community between 2010 and 2011 to pimp his faux concern about autism and measles jabs.  The result was a 50% uptake in the MMR jab as of 2013.  Even before his visits, Wakefield's fraudulent 1998 study linking MMR jabs to autism and visits from other anti-vaxx groups impacted this community and decreased the MMR vaccine uptake from ~90% to 54% sparking an outbreak in 2011 after his visits there.

Andrew Wakefield promised this community he would investigate their autism rate; he never did.  Instead he convinced them to eschew vaccination and gave them measles outbreaks.  That's the Wakefield Touch.

Update 18 April 2017:  The Minnesota Department of Health has confirmed a ninth measles case in Hennepin County in an unvaccinated child.

Update 20 April 2017:  The Minnesota Department of Health has confirmed  eleven cases of measles in Hennepin County all in children ages 1-5 years old, nine confirmed in unvaccinated children and nine in the Somali community.

Update 22 April 2017:  The Minnesota Department of Health has confirmed twelve cases of measles in Hennepin County all in children under 5 years old and all unvaccinated.  The uptake of MMR in the Somali community there is 42% in children under the age of two years old.

Update 25 April 2017:  The Minnesota Department of Health has confirmed twenty cases of measles in Hennepin County now.  One child less than one year old has been infected and 50% of infected children have been hospitalised.  Sixteen children have been confirmed unvaccinated.

Update 27 April 2017:  The Minnesota Department of Health has confirmed 24 cases of measles in Hennepin County.  Twenty-three of the 24 cases have been confirmed UNVACCINATED.  All children infected are five years old and younger. It has been confirmed that NONE of the infected children were vaccinated, 50% have been hospitalised and the infected children are between 10 months and 5 years old.  The outbreak may have emanated from a daycare.

Update 1 May 2017:  The Minnesota Department of Health has confirmed 32 cases of measles, 30 in Hennepin County and has spread with one in Ramsey County and one in Stearns County.  Of the 32 measles cases, only one child has received a single MMR jab, all others are UNVACCINATED.

Update 5 May 2017:  The Minnesota Department of Health has confirmed 41 cases of measles which has spread to Crow Wing County involving another unvaccinated child.  The stats of this outbreak are:
• 1 involves an adult and the rest are children age 10 or younger
• 39 involve people who were not vaccinated against the disease
• 34 are from Minnesota's Somali community
The case previously reported from Stearns County was ruled out as measles with confirmatory testing.
Anti-vaxx groups continue to stoke unfounded fears of vaccines causing autism among the Somali community in Hennepin County.

Update 8 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 48 cases.
  • 45 in Hennepin County
  • 2 in Ramsey County
  • 1 in Crow Wing County
  • 45 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 41 of the cases are Somali Minnesotan 
Update 11 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 51 cases:
  • 47 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 1 case has unknown vaccination status
  • 48 in children (ages 0-17 years)
  • 3 cases in adults
  • 46 of the cases are Somali Minnesotan 
Update 15 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 58 cases:
  • 49 in Hennepin County
  • 3 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 55 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 55 in children (ages 0-17 years)
  • 3 cases in adults
  • 49 of the cases are Somali Minnesotan
Additionally, the cost of this outbreak is estimated to be ~$1 Million Dollars.

Update 22 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 66 cases:
  • 56 in Hennepin County
  • 4 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 62 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 3 had 2 doses of MMR
  • 63 in children (ages 0-17 years)
  • 3 cases in adults
  • 57 of the cases are Somali Minnesotan 
Update 2 June 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 73 cases.
  • 64 in Hennepin County
  • 3 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 68 confirmed to be unvaccinated
  • 2 had 1 dose of MMR
  • 3 had 2 doses of MMR
  • 70 in children (ages 0-17 years)
  • 3 cases in adults
  • 60 of the cases are Somali Minnesotan

Tuesday, January 10, 2017

Anti-Vaxxer Robert F. Kennedy, Jr. to Chair a Vaccine Commission

U.S. President-Elect Donald Trump has met with anti-vaxxer RFK, Jr. to solicit him for a committee on vaccine safety and research integrity.  Sadly but not surprisingly such an appointment is on par with Trump's other picks for cabinet positions (although this isn't a cabinet position).  RFK, Jr.'s monomania regarding thiomersal has been debunked by the scientific community repeatedly.  Which leads me to believe that failure on that front will lead RFK, Jr. to turn his sights on "too many too soon" which Trump fervently believes.

It is unclear whether Trump is unaware of the CDC's Immunization Safety Office and the Vaccine Safety Datalink or simply doing an end run around them because he can't exert any direct control over them.  In any event, Trump is feeding his own anti-vaxx proclivities at the U.S. taxpayers' expense. Ultimately it is doubtful that anything meaningful will emerge from such a committee but that doesn't mean that RFK, Jr. can't cause a lot of trouble, not to mention the new life which will be breathed into the anti-vaxx movement.  How long before Andrew Wakefield is announced as a co-chair or committee member?

RFK, Jr. admits in an interview with ScienceMag that he has no expertise in science and will place "science people and prominent Americans".
How many people will be on the commission?
A dozen people -- a mix between science people and prominent Americans.
Who will you ask to serve?
I couldn’t tell you. I just finished meeting with the President-elect an hour ago.
When you say “science people,” do you mean experts from the scientific establishment?
Prominent scientists.
Do you mean prominent vaccinologists who believe in the safety and efficacy of today’s vaccines?
We are going to look for people who have expertise in toxicology, epidemiology and in public health.
Do you have scientific training?
No.  My background is I’m an environmental lawyer.  I’m not a scientist. But I have an expertise, I would say in reading science and spotting junk science because that’s what I do with most of my time.

Translation: He is going to look for people who might know a little bit more on the subject of vaccinology who are just as anti-vaccine as he is to launch a performance art showing.  Somehow I suspect that RFK, Jr. and his future committee members aren't exactly qualified to evaluate the science coming out of the CDC.  If it wasn't for the momentary pain in the arse RFK, Jr. and his little band of anti-vaxx warriors will cause for hard-working ethical people, it would be rather entertaining.

I am going to choose to look at the bright side of this which is another Trump rock will be turned over and we will get to see who crawls out.  Just as foisting Breitbart into the spotlight emboldened racists and let us see who they really are, this committee will undoubtedly have the same effect by emboldening anti-vaxx politicians and others who have cravenly kept to the shadows on the subject.  We will get to see who they are and may they have the same backlash inflicted upon them as the racist, bigoted Breitbart fake news site has.

Had organisations such as the Centers for Disease Control, the American Medical Association and the American Academy of Pediatrics been more proactive and damning of anti-vaxx quack physicians and activities, perhaps the creation of a committee such as this would have been more politically unsavoury.  It's time for these organisations, physicians and scientists to step up and push back against pseudo-scientific claims and those who make them and stop relying upon lightning-rods like Dr. Offit to be the only one doing their dirty work for them.

Robert F. Kennedy, Jr., Andrew Wakefield, Dr. Bob Sears and all their other associates are inexpert has-beens and wannbes but that doesn't mean their activities haven't done substantial damage to public health and public trust in our healthcare agencies.  It's time for all of us who are interested in public health and the well-being of our children to send a clear, organised message to these anti-science predators that their meddling in affairs that are way over their heads will not be tolerated.

Thursday, November 24, 2016

Aliana is dead

Aliana has passed away from SSPE, a severe, always fatal measles complication, this morning - in a short statement on their Facebook page, her father writes:

Our litte angel went on her way this morning. The last months were a hard time, she fought a lot, but sadly she lost. She went from us really peacefully with a beautiful smile on her lips. This is going to be a hard time for us, but Aliana has decided that she will be better where she is now, without suffering and without pain. We thank everyone who supported us until now and are still supporting us. Please light a candle, so we can accompany Aliana on her way to a better place.

I am tired. How often do we need to report on preventable deaths? My thoughts and deepest condolences are with her family. Please light a candle. Please vaccinate your children.

Friday, September 9, 2016

News in brief: Bob Sears to face medical board over recommendation not to vaccinate and poor record keeping

The OC Register reports yesterday (8 September 2016) that Dr Bob Sears has to face charges over "medical negligence" when he failed to take a detailed medical history of a toddler before writing him an exemption from further vaccination (and other oversights). He is also facing charges of poor record keeping, because apparently, this letter was not on the child's file.

The consequence for Dr Bob can range from a reprimand to the loss of his medical license.

I am sure this decision will find a lot of attention, given the recent introduction of SB277 in California, which mandates vaccines for school attendance unless the child has a medical exemption and fears that some "vaccine friendly" doctors would distribute such exemptions liberally without clear cause, undermining the public health benefits intended by the law. Dr Bob, whose "The Vaccine Book" had been criticised as fuelling irrational, scientifically unfounded, and potentially dangerous fear of vaccines, has been among the vocal critics of this law.

Orac gives a more detailed description of the charges (with a side of Insolence), as does the Poxes blog.

I would hope that any verdict of the medical board would be 100% based on the charges at hand (and any extenuating circumstances, i.e. other instances of writing medical exemptions without rigorous examination of the child, or lapses in record keeping) rather than the notion of making an example of Bob Sears to discourage other doctors.

Addendum (9.13.16): Richard Jaffe is representing Bob Sears.
“I represent Dr. Bob Sears in the California Medical Board’s case against him for writing a medical exemption from vaccination.
We take the board’s accusation seriously. But this case is very clear: this child had two unusual and severe vaccine reactions and his situation warranted a medical exemption. To continue vaccination could have put the child at risk of further harm.
All physicians have an ethical duty to do no harm to a patient. This is no less true when a child suffers serious side effects from any medical intervention.
We anticipate this case will do much to further public education on the importance of recognizing severe vaccine reactions and providing informed consent for medical care. ”

Rick Jaffe

let the education process begin! community support appreciated.


Monday, August 29, 2016

All Those HPV Vaccine Deaths Aren't After All

The Vaccine Adverse Event Reporting System or VAERS is a surveillance program designed to monitor post-market vaccine safety.  It is a passive surveillance system which means that entries are largely self-reported although healthcare professionals and vaccine manufacturers are required by law to report any adverse events from vaccines.  It also means that this type of reporting scheme can lack pertinent information regarding the vaccine, recipient and adverse event.  Select adverse events are followed up on although causality cannot be established; however a signal may be detected that warrants further investigation to examine the possibility of a correlation between a vaccine and adverse event, even very rare events such as between RotaShield and intussusception.

Reporting schemes such as VAERS are very useful when used correctly but they do have limitations and cannot be used to establish causality or for epidemiological studies.  Unfortunately VAERS is open to abuse by pseudo-scientists, laypeople, scientists with anti-vaccine agendas and even lawyers.  Those of us involved with the vaccine issue affectionately refer to this as VAERS dumpster-diving and unfortunately there is no shortage of dodgy investigators who engage in this deceitful activity.  One particular vaccine type stands out for VAERS abuse which protects against some strains of Human Papilloma Virus (HPV).  The current two vaccines are Gardasil and Cervarix.  It wasn't difficult to find an example of how egregiously VAERS is abused to make a personal, emotionally-overwrought argument in light of the fact that all serious adverse events are followed up on and none can be traced to HPV vaccines.

It just so happens that a fellow skeptic ScienceMonkey was kind enough to mine the VAERS database (for good and not for evil) and collate it to make the entries for "deaths" concise and readable for those who wish to demonstrate to the anti-vaxxer they are debating how HPV vaccines are not responsible for all the deaths they do like to claim.

VAERS (Vaccine Adverse Event Reporting System) is ONE of the CDC’s methods for tracking and documenting any potential negative reactions to vaccines. ANYONE can submit to VAERS. (Physicians would use the Vaccine Safety Datalink.) The details are open to the public and, as people are wont to do to promote their agendas, statistics can be manipulated and misrepresented. All of the VAERS data are accessible to the public and the individual reports are publicly-available in the VAERS Wonder system.

From the CDC: “A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described.  It only confirms that the reported event occurred sometime after vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.”

For reference, 80 million dose of Gardasil were administered in the U.S. between 2006 and 2015.

VAERS has 11 reports of people dying from HPV vaccines in 2011. Here are the report numbers with short synopses.

417137-1 Died 29 days after vaccination. Onset 29 days. F 17 TN.
419237-1 Anecdote from a filer of multiple reports.
421582-1 Anecdote. Cardiac arrest.
425513-1 Chronic depression. Suicide.
425598-1 Anecdote from a filer of multiple reports.
425680-1 Anecdote. Internet.
429007-1 Consumer reported he had nothing to live for because Gardasil killed his daughter.
430780-1 Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
437735-1 Relapse of ITP: 18-year-old female with immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab. Relapse in early April, 2011, followed administration of Gardasil vaccine on 10-26-10 and 1-7-11. Relapse of ITP led eventually to death from intracranial hemorrhage on 07/06/2011. Onset 84 days after vaccination.
437999-1 Suicide.
442402-1 Limited details. Patient on Depakote, Lyrica, Diazepam, Adderall for a Seizure disorder.

5 (45%) were anecdotes. 2 were suicides. 1 was not a death. 2 were clear other causes of death. 1 has limited information but onset occurred almost a month after vaccination. 1 patient has a disorder and was on other drugs.

There is no evidence in VAERS to support that any deaths can be linked to HPV in 2011.

VAERS has 6 reports of people dying from HPV vaccines in 2012. Here are the report numbers with short synopses.

449334-1 Symptoms onset 968 days after vaccination. Patient was found to be positive for a genetic mutation (FUS) recently recognized as associated with early-onset, rapidly progressive ALS.
450655-1 Limited detail. Michigan 2/27/12. (I can find zero external details on this one.)
453010-1 Limited detail. On other meds. Onset 9 days after injection 2.
457904-1 14-year-old male. Suicide.
464953-1 Anecdote, and “the nurses found that there was no record of the patient in local registry for GARDASIL patients”
471590-1 Anecdote was “from a consumer, who learned from a foreign radio channel of fatal cases after GARDASIL vaccination”

2 (33%) were anecdotes. 2 were other clear causes. 2 reports had very limited information and searches added nothing.

There is no evidence in VAERS to support that any deaths can be linked to HPV in 2012.

VAERS has 19 reports of people dying from HPV vaccines in 2013. Here are the report numbers with short synopses.

482344-1 Someone received something via social media and filed a report.
482352-1 Someone received something via social media and filed a report.
485188-1 Someone received something via social media and filed a report.
485757-1 A patient on anti-seizure medication and suffering from an upper respiratory infection died.
489163-1 Mother was vaccinated during pregnancy. Baby died 59 days after birth.
492468-1 Anecdote – someone knows someone who died.
494024-1 Patient had a cerebral hemorrhage and leukemia.
500225-1 Child passed out. Mother did research on the internet and heard about someone who died. There was no death here.
501081-1 Student found dead in dorm room three days after vaccination. Date and story likely link case to a well-publicized case. (The CDC/ATSDR Policy on Releasing and Sharing Data prohibits linking these data with other data sets or information for the purpose of identifying an individual.) The death was attributed to bulimia complications.
501663-1 Limited details. Nothing in file implying death liked to vaccines.
505344-1 Someone received something via social media and filed a report. File notes same person filing many similar reports.
505350-1 Someone received something via social media and filed a report.
505364-1 Someone received something via social media and filed a report.
510130-1 Patient died from myocarditis.
511528-1 Patient died from acute liver failure.
513554-1 Patient died 111 days after vaccination from influenza complications
513728-1 A mother claimed her daughter was killed by Gardasil five years earlier.
514814-1 Someone saw an anti-HPV video and filed a report.
515434-1 A asthmatic patient on Albuterol died 42 days after vaccination.

11 of 19 (58%) reports were anecdotal. 1 was not a death. 6 deaths were attributed to other causes. 1 death had limited detail in the file. The wording in some of the filings was identical. Some of the Wonder files even noted it was the same person doing many of the anecdotal filings.

There is no evidence in VAERS to support that any deaths can be linked to HPV in 2013.

VAERS has 16 reports of people dying from HPV vaccines in 2014. Here are the report numbers with short synopses.

518872-1 Patient on Adderall and Celexa died 44 days after receiving third Gardasil injection.
522070-1 Anecdote. Nurse reports of multiple people reporting internet anecdotes.
525311-1 Anecdote of 53 deaths.
526687-1 Patient with cardiomegaly. Myocarditis.
527990-1 Anecdote. Someone read something on Facebook that 15 people had died.
528766-1 Anecdote. Nurse read about something on a website.
532797-1 Patient had seizure 43 days after vaccination.
*538295-1 Patient died 1 day after Gardasil. Mother claims it was the vaccination.
540269-1 Anecdote of case 538295-1.
540899-1 Barely an anecdote.
541912-1 Anecdote of case 538295-1.
541916-1 Anecdote of case 538295-1.
544217-1 Anecdote of case 538295-1. (Physician aware of the anecdote corrected the age!)
546064-1 Anecdote of case 538295-1.
557260-1 Anecdote. Reporter claims deaths tied to Gardasil and product needs to be pulled from market. File states this reporter has done this many times.
559863-1 Anecdote of case 538295-1.

*I have to do a side note here on 538295-1 as I found this specific case on many anti-vaccination websites when I dove deeper. Based on the age of the girl, the date of the incident, and the location, I am certain of who this girl was. (The CDC/ATSDR Policy on Releasing and Sharing Data prohibits linking these data with other data sets or information for the purpose of identifying an individual.) The mother claimed the vaccination was the cause of her daughter’s death. The coroner found no causation from the vaccination and concluded the death was caused by diphenhydramine intoxication (Benadryl overdose). Despite the coroner’s conclusion, many anti-vaccination websites still tout this case. Six of the other filings for 2014 are for this specific case.

12 of 16 (75%) cases were anecdotes. 6 of the anecdotes were the same story!

There is no evidence in VAERS to support that any deaths can be linked to HPV in 2014.

Here’s a side note on disability filings for 2014: Permanent disabilities are said to be caused by HPV vaccines. 41% of the permanent disabilities out of a total count of 83 reported in 2014 were anecdotal. 7% of the reports had no disabilities reported. 10% were vague enough to where I “kind of” wanted more details and 15% were vague enough to where I really wanted more detail. Many filings were belief based – they “know the vaccine caused the harm.” 17% of the files noted the onset of adverse effects started more than 90 days after the vaccination. Several reported the onset occurred years after the vaccine.

There were 12 files where I really wanted more information and the results of the follow ups.

Several of the files noted their daughter’s attitudes changing after the vaccine. Since the attitudes of girls in their early teens are always extremely stable . . .

Here’s your 2015 “death from HPV vaccine” breakdown from VAERS/Wonder:

562128-1 Anecdote (Twitter)
568282-1 Allergic reaction symptoms 127 days after injection.
570801-1 Syncope. Died in ER 496 days after injection.
591496-1 Anecdote (television show)
597263-1 Anecdote (website)
603438-1 Anecdote (website)
607441-1 Anecdote (“one of several reports from the same reporter”)
611113-1 Anecdote (digital media)
611452-1 Upper respiratory tract infection anterior to the injection. Died three days after vaccination. Would like to see a follow up on this one, but couldn’t find anything from other sources.
611827-1 Anecdote
612231-1 Anecdote (online article)
612719-1 Onset 98 days after vaccination. Pontine Glioma Tumor.
613330-1 Anecdote (Twitter)
615613-1 Anecdote (website video)
615626-1 Anecdote (file even says “non-valid social media” spontaneous report)
616449-1 Anecdote (social media)

12 of the 16 (75%) are anecdotes, almost exclusively from the internet.
One had an allergic reaction 127 days after the vaccine.
One died 496 days after vaccination.
One had a pre-existing URI, but there isn’t enough detail in the file to say anything concrete either way. I couldn’t find any public detail on this and there is not any filing with the U.S. Court of Claims for a vaccine injury with details matching this case as of August 22, 2016. (If anyone has any details on this case, please post!)
One had symptom onset 98 days after vaccination. Death from brain tumor.

There is no evidence in VAERS to support that any deaths can be linked to HPV in 2015.

And now we enter 2016 where the art of data stuffing has caused the “deaths” to skyrocket. Here’s your 2016 “death from HPV vaccine” breakdown from VAERS/Wonder through August 22, 2016:

618174-1 Anecdote (Twitter)
618364-1 Anecdote (Magazine)
618411-1 Anecdote (Social Media)
619115-1 Anecdote (Social Media)
619116-1 Anecdote
619400-1 Anecdote (This one may be worth going into Wonder to read. Fun!)
619827-1 Anecdote (media, “Same filer”)
619835-1 Anecdote (online article)
621565-1 “Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.”
622366-1 Anecdote
622986-1 Brain tumor. 1,651 days after vaccination. For the mathematically impaired, that’s 4.5 years.
625990-1 Anecdote
626063-1 Anecdote (social media)
627312-1 Anecdote (Pharmacist inquiry. No death reported.)
628774-1 Anecdote (Report blamed death on “dTpa vaccine.”)
634742-1 Anecdote (“This is one of several cases received from the same source.”)
636334-1 Anecdote (“This is one of several cases received from the same source.”)
636483-1 Anecdote
638043-1 Anecdote
638257-1 Anecdote
639404-1 Anecdote
641317-1 Symptom Text field literally says just “Death.”

So 19 of 22 (86%) of the reports for 2016 through August 22 are anecdotes. One didn’t even have a death reported. One blamed the death on other causes. One was a brain tumor 1,651 days after vaccination. One said just “Death.”

There is no evidence in VAERS to support that any deaths can be linked to HPV so far in 2016.