More pseudo-scientific garbage from Tomljenovic and Shaw

By Helen Petousis Harris 02/05/2013 61


Persistent misuse of passively reported data – rat bags will always be rat bags but in the peer review and editorial process there is no excuse.

The Annals of Medicine are the latest (vaguely respectable but not to be confused with The Annals of Internal Medicine) journal to publish the mischievous works of Lucija Tomljenovic and Christopher Shaw. Yet again the core tenet of the article depends on the misuse of passively reported pharmacovigilance data.

Passive safety surveillance

One of the crude but effective tools of vaccine safety monitoring, versions of which are present in most countries in the world, are passive reporting systems. The general rule of thumb is that if an event occurs after getting a vaccine and it is considered adverse then it should be reported. Most countries welcome reports from both the public and health professionals, faxed, posted, emailed of or filled out online. Events reported to these systems include the likes of toothache, death, large injection site swellings, headache, broken legs, fainting and just about any other ailment to plague mankind, except plague, that is. In spite of all the “junk” collected these systems have proven remarkably successful in detecting genuine and often rare vaccine safety issues. Good examples are the detection of:

  • Onset of intussusception following the first generation rotavirus vaccine RotaSheild in the US, withdrawn from the market.
  • Onset of narcolepsy following a single brand of pandemic influenza vaccine in Europe, Use now restricted to adults only.
  • Febrile convulsions in children under five years following a sing brand of influenza vaccine in Australia and NZ, use now restricted to older children and adults.

Of course, once a safety signal has been detected other methods are used to confirm the signal, verify the signal and determine risk and association. It is not like safety monitoring is left to passive monitoring the way anti-vaxxers like to say.

Passive safety systems cannot tell anyone what the cause of an adverse event was and it is NOT a matter of post hoc ergo propter hoc. Raw data must never be used to imply causality. To do so is either ignorant or devious and ignores all the caveats that the guardians of the data clearly state, not to mention common sense. As an example, the US passive reporting system Vaccine Adverse Events Reporting System (VAERS) states:

Guide to interpreting VAERS Case Report Information

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event. 

There follows a list of statements that one is supposed to read on the limits of the database and one is required to click on a box to acknowledge understanding of the statement.

So does this make academics that report this as raw data in manuscripts published in journals whose quality ranges from dubious to reasonable ignorant or devious with a deliberate intent to mislead?

Mmm, I am thinking the latter.

Over the last year or so a pair of ophthalmologists has published quite prolifically in an eclectic collection of scientific journals, mostly centred on reiterating the mantra that HPV vaccine may not prevent cancer, causes death and disability and people are not being informed. Gross limitations in their science have been pointed out by folks like OracScibloggers Alison CampbellGrant Jacobs and many others. I had a go at critiquing their garbage too.

Aside from the elephants in the room – how does this stuff get published; who peer reviewed it; who is the editor that allowed publication? The blatant misuse of information has arisen yet again in the March edition of Annals of Medicine.

Below are two of their mantras which are cased in innuendo.

1. Ability of HPV vaccine to prevent cervical cancer.

The role of HPV in cervical cancer is scientifically undisputed. If a woman develops abnormal cell growth on her cervix it is treated before cancer develops. No study has cancer as an endpoint if it can be prevented.

A common argument among anti-vaxxers is that because the HPV clinical trials did not have cancer as an endpoint (women who developed cervical dysplasia were inconveniently treated so that progression to cancer did not occur) there is therefore no evidence that the vaccines can prevent cancer. According to Tomljenovic and Shaw

At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination. 

This seems like flawed reasoning to me. Bit like not using a parachute when jumping out of a plane because no one has done a randomised trial to confirm that parachute is indeed better that placebo at preventing death and disability after the gravitational challenge (great paper for a laugh in BMJ on this as an extreme example). Those with common sense are satisfied that gravity is an essential step in the process of falling to earth with a bump. Remove gravity, no problem.

Also, using the fact that most women clear HPV infections as an argument is irrelevant.

“…even persistent HPV infections caused by ‘high-risk’ HPVs will usually not lead to immediate precursor lesions, let alone in the longer term to cervical cancer. The reason for this is that as much as 90% HPV infections resolve spontaneously within 2 years and, of those that do not resolve, only a small proportion may progress to cancer over the subsequent 20 – 40 years”

This does not change the fact that cervical disease including cancer occurs in many women. Not everyone who smokes dies of lung cancer either, most smokers do not die of lung cancer. This is a red herring argument.

2. Misuse of passively collected data

Where the paper goes from just lame to deceitful is in the presentation of VAERS data. This is outright dishonesty.

“…in the US, the current age-standardized death rate from cervical cancer according to World Health Organization (WHO) data (1.7/100,000)  is 2.5 times lower than the rate of serious adverse reactions (ADRs) from Gardasil reported to the Vaccine Adverse Event Reporting System (VAERS) (4.3/100,000 doses distributed).”

Seriously?? Firstly, how can you compare an age-standardised death rate from cervical cancer with spontaneously reported serious adverse events per 100,000 doses of vaccine distributed and then go on to discuss risk to benefit balance??? Various types of fruit spring to mind.

They later state

“Cumulatively, the list of serious ADRs related to HPV vaccination in the US, UK, Australia,  Netherlands, France, and Ireland includes deaths, convulsions, syncope, paraesthesia, paralysis, Guillain – Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.”

Going back to the limitations of the VAERS data that are outlined on the web page preceding access to the data, the one with the box to click on acknowledging that one understands this information:

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

… 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.

…. VAERS data should be used with caution as numbers and conditions do not reflect data collected during follow-up.  Note that the inclusion of events in VAERS data does not infer causality.”

So Tomljenovic and Shaw completely ignore all of this information (or is the above not explicit enough?) aside from the fact that the issues are blatantly obvious to anyone vaguely rational, the fact that the VAERS data are deliberately misused renders the entire paper not only complete garbage but technically fraudulent.

For the record, the first two and a half years data from VAERS was analysed and published in JAMA in 2009 and assessed patterns of all adverse events from the point of introduction of HPV vaccine. Clinical review of medical records associated with the reports was undertaken. Of note and available to cite since 2009 is that the deaths reported were caused by: diabetic ketoacidosis, prescription drug abuse, juvenile amyotropic lateral sclerosis, Group B meningococcal disease, influenza B viral sepsis, pulmonary embolism, arrhythmias, myocarditis and idiopathic seizure disorder. Of the cases with records, there were four unexplained deaths. None considered to be caused by administration of HPV vaccine.

A 2011 follow up study in the US after the administration of over 600,000 doses using a scientific methodology that looks at vaccine exposure and pre-specified outcomes found no increased risk for any of the events noted in the Tomljenovic and Shaw paper although further study of venous thromboembolism was recommended.

Shame on you Annals of Medicine.


61 Responses to “More pseudo-scientific garbage from Tomljenovic and Shaw”

  • The now legendary example of how anyone can file any possible adverse effect to VAERS is Dr. James Laidler who sought to demonstrate this,

    “The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.”

    (His ‘giant green monster’ adverse effect was eventually removed.)

  • Helen, Peter told me to look out for “The new expert blogger on vaccines.”

    You say, “Of the cases with records, there were four unexplained deaths. None considered to be caused by administration of HPV vaccine.”

    Can I ask, “Considered by whom, and following what comparative analysis.?”

    • ‘Unexplained death’ means the cause death was unexplained. If it was considered that the vaccine played a role in the death, then the death would be ‘explained’.
      I am no expert on the investigation of sudden unexpected death in the US, but imagine it is similar to NZ processes which would likely include an autopsy with associated toxicology and other tests. Considered by relevant experts. My interpretation of your question is that you are making an argument from ignorance “argumentum ad ignorantium” whereby the absence of evidence (in this case proof of cause of death) is in some way proof that the deaths may be caused by HPV vaccine. Whatever has not been proved false is not necessarily true.

  • Hi Helen

    Your interpretation is interesting as that is not what I asked.

    Let me comment and parse my questions so that you understanding is the same as mine.

    Firstly, definitive safety is defined by absence of evidence of harm.

    Secondly, you use the words unexplained deaths and unexpected deaths. From you response I gather you are not using these as synonyms… but suggesting that unexpected deaths could be explained or unexplained. Eg, sudden unexpected death of an infant (SUDI) could be explained (eg, suffocation) or unexplained (SIDS).

    No doubt you are aware that causality is is classified along a continuum and is not classified in terms of black and white. You say that NZ processes relating to assessment of cause of sudden unexpected death in NZ would likely include an autopsy with associated toxicology and other tests.

    When one is dealing with unknown causes of death (unexplained) then one needs to keep an open mind and not discount hypotheses simply because they are worrysome. In the case of Jasmine Renata, it seems that if her death was not related to Gardasil then surely it is in vaccine proponents interests to engage with any alternative hypotheses, rather than dismiss them because they don’t fit the mold.

    You say, “If it was considered that the vaccine played a role in the death, then the death would be ‘explained’.”

    I’m aware of plenty of situations where something is considered to play a role in something, but the ‘how’ is not known… therefore it is still unexplained. Eg, a car could roll over killing a driver… but why the car rolled over is unexplained.

    You didn’t answer either of my original questions;

    You say, “Of the cases with records, there were four unexplained deaths. None considered to be caused by administration of HPV vaccine.”

    Can I ask, “Considered by whom, and following what comparative analysis.?”

    .

    • Gosh, I assumed your questions were rhetorical. Of course I do not know who performed the assessments and prepared the conclusions about these deaths, perhaps you could consider contacting the authors of the paper for their answer.

      My point is that the data from VAERS is deliberately being used inappropriately and the system is not designed to attribute causality. The information on the deaths comes from medical records and autopsy reports that were followed up, not from the VAERS system.

      Your comments about a lack of interest in following up Jasmines death (with the sort of woo that Lee and Shaw peddle) is unfortunate given that it is said that Jasmine’s family refused the available genetic tests for these conditions. Others have commented previously, See Orac and Grant Jacobs.

      I have enormous sympathy for Jasmines family and do not think this type of muckraking is helpful to anyone.

  • I believe RonL’s question “Considered by whom” has been answered: “an autopsy with associated toxicology and other tests. Considered by relevant experts.”
    As this blog is about immunisation not post-mortem analysis and experts with scientific credibility limit scientific comment to their area of expertise the question “following what comparative analysis” would best be posed to a forensic pathologist, histopathologist, bichemist, toxicologist and geneticist.

  • We all know how accurate doctors are when it comes to diagnosis… “Diagnoses that are missed, incorrect or delayed are believed to affect 10 to 20 percent of cases, far exceeding drug errors and surgery on the wrong patient or body part, both of which have received considerably more attention.

    Recent studies underscore the extent and potential impact of such errors. A 2009 report funded by the federal Agency for Healthcare Research and Quality found that 28 percent of 583 diagnostic mistakes reported anonymously by doctors were life-threatening or had resulted in death or permanent disability. A meta-analysis published last year in the journal BMJ Quality & Safety found that fatal diagnostic errors in U.S. intensive care units appear to equal the 40,500 deaths that result each year from breast cancer. And a new study of 190 errors at a VA hospital system in Texas found that many errors involved common diseases such as pneumonia and urinary tract infections; 87 percent had the potential for “considerable to severe harm” including “inevitable death.””

    http://www.washingtonpost.com/national/health-science/misdiagnosis-is-more-common-than-drug-errors-or-wrong-site-surgery/2013/05/03/5d71a374-9af4-11e2-a941-a19bce7af755_story.html

    The above story gives an account of “relevant experts” screwing up where mere ‘residents’ shamed their misdiagnosis of a throat cancer.

    Attempting to degrade peer reviewed studies with terms such as, “More pseudo-scientific garbage”and ” mischievous works” is unbecoming of one lauded as an expert. No doubt it will be music to the ears of believers, but it does nothing to advance any logical or rational discussion.

    You say, “Of the cases with records, there were four unexplained deaths. None considered to be caused by administration of HPV vaccine.”

    The paper makes no such claim… the paper never looked at/determined individual causality of death.

  • “In the case of Jasmine Renata, it seems that if her death was not related to Gardasil then surely it is in vaccine proponents interests to engage with any alternative hypotheses, rather than dismiss them because they don’t fit the mold.”

    Alternatively (and only slightly more ridiculously), it would surely be in the interests of the manufacturer of the mattress she was sleeping on to engage with a claim that she died from mattress poisoning.

    The manufacturer is interested in whether their product is safe. Assuming that their product is found to be safe and identified as NOT the cause of injury, their interest naturally lapses.

    To put it in the context of your car crash analogy, a car manufacturer is not going to pursue the underlying cause of a single crash once the possibility of mechanical failure is ruled out.

    “…don’t fit the mold.” is an interesting turn of phrase. More honestly you should surely phase it more “don’t match the available evidence”.

  • For the record, Dr Barbara Slade verified the medical, autopsy, and certificate of death reports. She’s a Pathologist by training and also a Senior Medical Officer.
    To be clear- reports to VAERS are simply reports of adverse events that occur after receipt of one or more US-licensed vaccines. There is no assumption of causality. It is important to note there was no pattern of death in terms of dose number, timing of death after the HPV4 vaccine, or autopsy findings.
    Helen has made a very relevant point about VAERS- when reviewing data from VAERS, keep in mind the limitations:
    1. VAERS is a passive reporting system, meaning that reports about adverse events can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Because of this, VAERS data may and often does include incorrect and incomplete information. Underreporting, or failure to report events, is also one of the main limitations of VAERS.
    2. Serious medical events are more likely to be reported than minor ones.
    3. VAERS cannot determine cause-and-effect. The report of an adverse event to VAERS does not confirm that a vaccine caused the event.
    4. VAERS only indicates that the event occurred sometime after vaccine receipt. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report.
    5. VAERS accepts all reports without judging whether or not the event was caused by the vaccine.
    There is more information on the limits of VAERS data can be found at http://vaers.hhs.gov/data/index

  • I am constantly shocked by the complete lack of rational thought that seems to follow arguments made by experts. It is almost impossible for even the most rigorous scientific process to discount something with 100% certainty, because very simply, there are no certainties.
    The problem with people who refuse to believe the available evidence and seem to enjoy scaremongering is that nothing will ever satisfy them- once the vaccine itself has been declared safe under all required standards, the components then become the new evil, with faceless pharmaceutical companies being made out to peddle folk remedies or, even worse, dangerous therapies just because it profits them.
    I understand that some people simply don’t have the time to read through numerous reports detailing exactly how vaccines and the like have been tested and declared safe- but these people should then under no circumstances call themselves experts or advocate dangerous practices (non-vaccination and unpasteurised products just to name two examples) when they don’t have the scientific background to understand the consequences of their actions.

  • I am constantly shocked by the complete lack of rational thought that seems to follow arguments made by experts. It is almost impossible for even the most rigorous scientific process to discount something with 100% certainty, because very simply, there are no certainties.
    The problem with people who refuse to believe the available evidence and seem to enjoy scaremongering is that nothing will ever satisfy them- once the vaccine itself has been declared safe under all required standards, the components then become the new evil, with faceless pharmaceutical companies being made out to peddle folk remedies or, even worse, dangerous therapies just because it profits them.
    I understand that some people simply don’t have the time to read through numerous reports detailing exactly how vaccines and the like have been tested and declared safe- but these people should then under no circumstances call themselves experts or advocate dangerous practices (non-vaccination and unpasteurised products just to name two examples) when they don’t have the scientific background to understand the consequences of their actions.

  • You wrote “My point is that the data from VAERS is deliberately being used inappropriately and the system is not designed to attribute causality.”.
    And yet, your argumentation about validity of the report is based on the the assumption, that there is no probability of that causality in the data whatsoever (or even worse the probability of causality in real life which is not visible to you through the data). So, please explain, on what grounds (logic/statistics/other) you inference from “could not”, to that there “must not” be a causality?

    • I hold no such assumptions. A report to VAERS may or may not be causally related to a vaccine. The point is that there is no way to know this from the VAERS data. OTher information and approaches are required to address issues of causality.

  • It would be far more interesting if many and farflung people reported the same hulking after the same vaccine! An organised conspiracy to lie, perhaps more subtly done(!), could undermine the system. But isn’t it obvious that bad data leads to bad conclusions? I’m not sure that Jim Laidler’s stunt actually illustrated anything worth illustrating … only that system isn’t set up to jump to conclusions from isolated one-off anomalies, which is pretty obvious anyway!

    • You not only need at least a few people reporting the same hulking but in order to support a causal role of the vaccine you need to observe more hulkings in your vaccinated group than you would normally expect. While Jim Laidler illustrated that anyone can report anything, which is not a trivial point, indeed you need more than a one-off anomaly. IF one person turned into a hulk after a vaccine but no one else did then it is ultimately of little concern to public health. Of course if hulks started to pop up all over the place then the question is: Are hulkings more likely in vaccinated people? If so then we would certainly have a problem with the vaccine!

  • Yes, though I think it is safe to say that we would normally expect zero hulkings in the vaccinated group! So, say just a dozen apparently independent reports of hulking after the same vaccine would pretty conclusively indicate either (1) a causal relationship between the vaccine and hulking; or (2) an organised conspiracy to deceive! For something less ridiculous than hulking, this might be difficult to detect…

    • A dozen or so hulkings after same vaccine may indicate a safety signal or organised conspiracy to deceive but not a causal relationship. We will need to compare our vaccinated and vaccinated for that. A more likely event than hulking may be the onset of multiple sclerosis after HepB vaccine or a convulsion after flu or MMR vaccine. These are real life examples detected in systems like VAERS and later verified to be not causally related in the case of MS and causally related in the case of febrile convulsions.

  • Stephen – to second Helen’s points, the point of Jim’s exercise was not to show “that system isn’t set up to jump to conclusions from isolated one-off anomalies”—which as you say is obvious anyway—but to show that anyone can file anything to VAERS.

    As one somewhat extreme example, there apparently have been cases of lawyers trying to set up their suits by getting their clients to file reports, then use the reports—not clinical confirmations—as the basis of (attempted) suits. The catch is that because anyone can file anything, the filing in and of themselves mean little until they are examined further.

    Similarly, many of the anti-vaccine groups ‘encourage’ their followers to file reports.

  • Grant:
    Yeah, but I would have thought it equally obvious that anybody can file anything to VAERS? As an amusing aside, I notice that most of the recent Wellington earthquakes have been reported as being felt in Hamilton, even when someone I know in Wellington didn’t feel them! The GNS site has a “felt it” button. I wonder if that has something to do with it?? You go on to say [quote]Similarly, many of the anti-vaccine groups ‘encourage’ their followers to file reports[unquote]. Well, that counts as an organised conspiracy to deceive, according to my definition. I’m not disagreeing with anything here, but just suggesting that Jim Laidler’s stunt was just that, a stunt which demonstrated nothing that we didn’t all already know. However, the disclaimers of VAERS itself, as quoted in the article above, don’t make it clear that any report could be falsified by the reporter, they seem to assume good faith! [Quote]VAERS accepts all reports without judging whether the event was caused by the vaccine[unquote], and also accepts reports without judging their credibility! Jim’s stunt has highlighted that fact, I suppose, though I don’t know why anyone would think that credibility of reports could be judged, especially if they are more subtle lies than hulking!

  • Stephen –

    You’re missing the boat, I think. We know anyone can file anything, but the anti-vaccine groups spread the idea that the filed reports in and of themselves are meaningful, which they are not. Jim’s actions were intended to demonstrate, not just say so, that that’s not true as an actual example to help counter the incorrect message being spread.

    “Well, that counts as an organised conspiracy to deceive, according to my definition.”

    Not necessarily, in fact I don’t think it’s likely. Many (most) of the parents in those groups are simply people who have been badly informed and sincerely are concerned about their kids. They aren’t intending to deceive, they’ve been mislead by the peer-group they belong to. (The core few running, say, SaneVax [sic] are another matter.)

    “they seem to assume good faith”

    They have to assume good faith, it’s an open report gathering system.

  • Yes, I understand your first point. But, it would have actually have been BETTER, in my opinion, for Jim to have used a subtle example, rather than an obviously ridiculous one, as people won’t necessarily appreciate that reports which look credible may not be. They will, in their fallacious way of reasoning, try to argue that the hulk example was an obvious deceit, and that they can “feel it in their gut” when data is wrong!

    As for your second comment, did I say “intention to deceive”? Did I specify who the conspirators were? You assume I mean the reporters themselves. Wrong! I mean’t those who are influencing them!

    As for good faith, I think they should add an explicit disclaimer to the effect that reports are accepted uncritically…

  • a stunt which demonstrated nothing that we didn’t all already know.

    What Grant said – we might be aware of it – & in fact I wasn’t, myself, until after Jim’s stunt was publicised – but many (most?) are not & tend to treat VAERS as gospel truth.

    Also, how do you suggest that VAERS ‘judge the credibility’ of reports?

  • I suggested that they don’t and can’t ‘judge the credibility’ of reports (though actually they probably could in the case of hulking!), so should say that explicitly in the disclaimers, i.e. reports are accepted uncritically … for the benefit of those who can’t see the obvious for themselves …

  • “ did I say “intention to deceive”?” – you wrote organised conspiracy” – being organised implies intention.

    Regards your suggestion that a more subtle example used, two thoughts.

    There are already examples. Helen gave two and I’m sure there are others.

    In my experience subtly doesn’t work well on people who are fairly determined to hold a particular stance. I would think strong, clear examples I would think are more likely to be useful. (Subtle examples might be useful for those who are more open-minded.)

    On this general subject I introduced two reports examining the local vaccination scene earlier this year; the second offers some suggestions on ways to address those reluctant to vaccinate.

  • Although I do have sympathies for your concerns on this issue, I do have to wonder what all the whinging and whining on a blog is likely to achieve? A journal, like “Annals of Medicine” (yep, that’s a journal!), may well be more concerned by its impact factor and actually actively seek to publish “controversial” research. This blog is just fueling that controversy. Ultimately, bad science is a product of equating success with popularity, or, if you like, quality with quantity. This is a problem which is manifest in much of human activity. Money is often at the root of the problem. Not sure what we can do about it …

  • I do have to wonder what all the whinging and whining on a blog is likely to achieve?
    Well, for a start, science blogs do quite a bit to put information out there in the public sphere. Journal articles aren’t necessarily all that accessible to the general reader & in my experience journalists in the local media don’t always do a particularly good job in bringing scientific information to their readers. Many of the blogs here have a wide readership and several of us are regularly asked to provide commentary in mainstream media (most recently, Siouxsie Wiles yesterday morning). So I would argue that science blogs have the potential to achieve a fair bit in terms of communication/education around scientific issues.

  • Fair enuff, though, as I tried to suggest to Ken Perrott, extremism in the opposite direction isn’t objectivity, and I rather do object to equating sceptic with crank, and that sort of thing. You don’t seem too bad, though …

  • I have not read the paper in question, only the above “critique” which is really more of a mudslinging effort than a true scientific review. Anytime pejorative language like, “pseudo-scientific garbage” is used, I generally don’t give much weight to the opinion of an obviously biased and frankly, unprofessional author. Certainly, the argument made regarding the use of VAERs data is relevant. However, what else has the author got to use? She could only use what data she has available to make her argument. There is a glaring lack of studies/research to determine long term (or short term, for that matter) effects of vaccination. Additionally, by their own admission, the CDC recognizes that adverse events are greatly under reported. The author of this “critique” slanders Dr. Tomjlenovic by openly suggesting she is purposely being deceitful. I wonder, at what gain? Anyone who dares question the efficacy and/or safety of vaccination are generally publicly and professionally eviscerated, ostracized and ridiculed (case in point). What would be her possible gain in pursuing this tack? Sadly, instead of true scientific debate we too often see emotionally biased hack jobs like the above. By the way, I’m not a “antivaxer”….I’m simply pro-science with common sense. Show me safety and efficacy, and I’m on board.

    • Perhaps you should read the paper, and all the other papers by the same authors. The material is NOT scientific and if you are ‘pro science’ and apply the scientific method you will immediately recognise this fact. Also, suggest you read what I actually said and follow up on the links.

      Your failure to appreciate that there are many scientific studies monitoring the long term safety of vaccines suggests you are unfamiliar with this area. The safety of vaccines is constantly being challenged by the scientific community. Some recent examples include influenza vaccine and narcolepsy, influenza vaccine and febrile convulsions, MMRV vaccine and febrile convulsions and Rotavirus vaccine and intussusception. Given I have personally researched and published on this issue for the very purpose of identifying and quantifying the safety of a vaccine which resulted in the restricted use of the vaccine your comment is a bit redundant.

    • No, it hasn’t, to the very best of my knowledge.
      Very sad for family not getting that closure after so long.

  • @Sean, as Helen says there are actually a lot of studies monitoring the effects of vaccines – both long and short term. Especially the HPV vaccine, which is now extremely well studied.

    Also there is a difference between using the VAERS data naeively as statistically relevent on it’s own the way these authors do and using it as a starting point and actually investigating the events, determining the circumstances and calculating relative risk the way serious researchers would.

    In fact this analysis has been done properly and here it is:
    http://www.aerztekammer-berlin.de/30buerger/HPV/Weiterf__hrende_Links_f__r_Fachleute_index/YAMA_2009_Slade_HPV_NW_2009.pdf

    Which I covered in 2009:
    http://sciblogs.co.nz/skepticon/2009/09/27/gardasil-post-licensure-study/

  • mythbuster –

    The impression you get from the coroner’s website is that only the cases considered to be of public interest are advertised as available. Maybe the coroner has decided the case isn’t in the public interest? (If that’s the case it may not be a bad move.)

    I’ve read Hilary’s silliness (let’s be frank) a while back. Hilary has written that she volunteered herself to the Renatas after Jasmine died and she wrote plenty earlier on this earlier, as you may know.

  • I agree with Sean, just a couple of comments above. I’ve never seen such ‘mudslinging’ as I have from all the ‘scientific’ commentators who are writing about the vaccine concerns expressed by others.

  • @Dr. Helen Petousis Harris, I read your attack piece, er, article, and I found it to be extremely personal, “rat bags will always be rat bags etc.” If I didn’t know any better, I would think that you could stand to suffer significant personal loss if Dr. Tomljenovic’s claims turn out to be true. Could it be that you have a financial obligation with the Immunisation Advisory Centre to discredit any heretic that dares to threaten the pseudo-scientific status quo. Don’t you think that articles like this one would be best written by someone without a “bone to pick?” As an investigator of a crime, you would probably be required to recuse yourself because of the personal interest which may taint your viewpoints. I guess those points are lost on the scientific community. Maybe you should force Dr. Tomljenovic to drink hemlock for her heresy.

    • Not sure what you are saying. Are you suggesting I get paid by someone who sells vaccine or has a financial interest in them? If so then no, you are incorrect. I get paid a salary by the University of Auckland and no one else. My only interest is in maintaining the integrity of science.

  • Caleb
    Do you really feel this is an ‘attack piece’?
    From what I see Helen is practicing good scientific scepticism- It is hugely important is to read the papers Helen has referenced in the blog.
    When you read the Tomljenovic and Shaw article “Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?”
    http://informahealthcare.com/doi/abs/10.3109/07853890.2011.645353
    What type of information do you think is being given- Honestly do you think is it factual or can you agree is it pseudoscience? When an author deliberately uses passively collected data such as the VAERS data -their goal is only to mislead and scaremonger!
    The authority of science being disseminated needs to be proven before it is pass to the masses- who would you listen to?
    Helen Petousis-Harris who is an academic Lead for Immunisation Research and Vaccinology at the Immunisation Advisory Centre and a senior lecturer at the University of Auckland with a background in biological sciences including immunology and a PhD in Vaccinology.
    Or Lucia Tomljenovic from a Department of Ophthalmology & Visual Sciences?
    I would not have considered this article as one that is bone picking but rather one that clarifies the muddy water being swirled about by those who would trick, mislead and confound others.

  • ” Don’t you think that articles like this one would be best written by someone without a “bone to pick?” As an investigator of a crime, you would probably be required to recuse yourself because of the personal interest which may taint your viewpoints. I guess those points are lost on the scientific community.”

    That’s rather like arguing that a detective isn’t qualified to investigate a crime because they’re paid by the state to investigate crime. If you’re a good scientist, chances are someone will pay you to do science, whether that’s a university,non-profit or other private sector organization. If getting paid to do science disqualified you from writing about your area of expertise, then you’d only ever have amateurs writing about it. Think for a minute what that would do to the quality of scientific knowledge that our society relies on. It would be like having nobody but untrained electricians allowed to do electrical work.

  • Ironic how she still has her medical license… and the fraudulent Dr Wakefield had his license revoked for lying – PROOF Tomljenovics report resonates truth – shame on you! oh and 27 years of being unvaccinated, im still here 🙂

    • Mmm, except:
      1. Wakefield didn’t have his medical licence revoked for lying per se. It was revoked because he performed invasive unpleasant experiments on small children without cause and without ethical approval and falsified the data and lied about the ethics. In addition he did not declare massive conflicts of interest.
      2. Tomljenovic doesn’t have a medical licence to revoke, She is PhD in biochemistry – also worth noting that Tomljenovic is not guilty of the same crimes (hurting small children). Only spreading misinformation.

  • Helen – Sorry, agree with the previous authors – it is not scientific review. References? None. Biased. Poor argument. Like the gravity and HPV. The outcome measure in HPV was NOT death rate – therefore, to say otherwise is not science. It is speculation. Have you done any science at all? I am starting to doubt…Do your homework a bit more thoroughly my young student pretending to be a professor…

  • ll, Would you care to exactly make your points clear and explained, maybe expand on your heavy handed (and rather short) explanation and where it comes from? Perhaps try your own review of the actual review instead of solely trying to degrade the authors integrity. It would be good to see your science in action. Perhaps we may have reason to disagree or agree with you.

    Thanks

  • Hello,
    Here because of the thesis turmoil.

    I have a question does the company that provided a vaccine with clear unidentified side-effects gets a fine when they are a posteriori discovered? I think that the fact that such a problems exist is frightening for the consumer. Could you link information about the prevalence of such issues?

    When you say:”This seems like flawed reasoning to me. Bit like not using a parachute when jumping out of a plane because no one has done a randomised trial to confirm that parachute is indeed better that placebo at preventing death and disability after the gravitational challenge (great paper for a laugh in BMJ on this as an extreme example). Those with common sense are satisfied that gravity is an essential step in the process of falling to earth with a bump. Remove gravity, no problem.”

    I think you are voluntarily simplifying the debate and being dishonest, there is a clear consequential link between fall and injury and between fall altitude and gravity of the injury. And there is plenty of randomized trial performed through history to demonstrate it. The fact that they are not done under scientist supervision does not dismiss them as valuable information.

    The role of HPV in cervical cancer is scientifically undisputed. If a woman develops abnormal cell growth on her cervix it is treated before cancer develops. No study has cancer as an endpoint if it can be prevented.

    Is there any in vitro study, to the least? I mean how do you assess the performance of this vaccine? You have to give that information we are not all specialized in the topic. It is unbelievable, you expose no argument, no study, nothing. This text is pretty much empty. Maybe that is why it is in blog and not a pair reviewed article.

    ““…in the US, the current age-standardized death rate from cervical cancer according to World Health Organization (WHO) data (1.7/100,000) is 2.5 times lower than the rate of serious adverse reactions (ADRs) from Gardasil reported to the Vaccine Adverse Event Reporting System (VAERS) (4.3/100,000 doses distributed).”
    Seriously?? Firstly, how can you compare an age standardised death rate from cervical cancer with spontaneously reported serious adverse events per 100,000 doses of vaccine distributed and then go on to discuss risk to benefit balance??? Various types of fruit spring to mind.”

    Well, why not? If the doses are distributed to all the population? Anyway, that does not invalidate the first argument of, is the thing useful in the first place. If it is not proved to be useful all the following argument is pointless because he is just adding insights into the dangerousness and your dismissing it on the basis of absence or quality of the information.

    I think the fact that you are so virulent goes against your point. You are a scientist, not an alcoholic at the bar. Your constant inversion of the burden of proof is extremely unsettling.
    Shame? Why? This a debate, no one should be ashamed of his opinions.

    “But still, it moves,” Galileo.

    Is it possible to find your conflicts of interest? Any links to PEER REVIEWED article on the topic? Your PEER REVIEWED articles on the topic? You disqualify a peer reviewed article from a blog…

    Nicolas Martino
    PhD candidate at uow in chemistry.
    Bachelor of biochemistry.

    • Is there any in vitro study, to the least? I mean how do you assess the performance of this vaccine?

      The performance of the vaccine is assessed using Randomised Placebo Controlled Trials. In the case of Gardasil these included over 30,000 women. After licensure safety and effectiveness are monitored in large populations by comparing outcomes in vaccinated and unvaccinated. So far these studies include over one million girls and women.

      Well, why not? If the doses are distributed to all the population? Anyway, that does not invalidate the first argument of, is the thing useful in the first place. If it is not proved to be useful all the following argument is pointless because he is just adding insights into the dangerousness and your dismissing it on the basis of absence or quality of the information.

      Why not? Because that would not be a remotely scientific approach. The key epidemiological tools are randomised trials, cohort studies and case-control studies that compare exposed with unexposed. Anything else is pissing in the wind.

      • The ‘placebo’ used in the Gardasil trials also contained aluminium, and it was therefore not a true placebo controlled study. This type of smoke and mirrors tactic by the vaccine producers is unacceptable. The fact that CARM is a passive reporting system and that no scientific curiosity is displayed to follow up on serious adverse events is nothing short of irresponsible. If the MOH had any real interest in the health of citizens fully informed consent – not just the pathetic information in current vaccine consents – would be sought, and in the light of the numbers who report being affected adversely, an active and concerted effort should be made to follow up on the vaccinated to study the true effects.
        And your statement above regarding Vaxxed is just rubbish. I doubt that the TriBeCa officials have communicated with you in any way so your statement above is nothing more than a guess and at best a biased opinion. Even if it were nonesense, as you believe, is it any more nonsensical than three quarters of movies released. I doubt it. Really it was withdrawn because political pressure was brought to bear by those whose agendas it does not suit to have it praised for its revelations.

        • The fact that CARM is a passive reporting system and that no scientific curiosity is displayed to follow up on serious adverse events is nothing short of irresponsible.

          Are you serious?? Adverse Events Following Immunisation is one of the most rigorously researched areas in health and medicine, repeatedly highlighted in my blog. Active surveillance in the form of cohort, case-control, data linking and other methods is occurring all the time all over the war ld including here in NZ. Studies comparing out comes in vaccinated and unvaccinated. Suggesting the world only relies on passive reporting is dishonest. Shame on you.

          • Funny that we see and hear no evidence of this rigorous follow-up. Not one of the parents that I know of Gardasil injured children has ever had official follow-up to hear their stories. If there are follow ups where are they reported. I suggest we firstly challenge the MOH to get FULLY INFORMED consent for these vaccines including the information that the vaccine has never been proven to prevent cervical cancer. I further challenge the MOH to run surveys monthly to request active feedback from the vaccinated on their ongoing health post vaccine ( a simple survey system could be set up). Further active monitoring would be quite simple if doctors, instead of simply denying any link to the vaccine, actively investigated and reported back on findings – starting with actually recognising the battery of symptoms that present in their offices.

            And as for your ‘shame on me comment” I reply shame on you for the regular mocking and belittling of parents of vaccine injured children. Your blanket denials of the link between vaccines and the injuries is nothing short of heartless. We are not fooled by your vaccine bias. We would gladly support vaccines that were proven to be safe but those you so zealously promote have a less than glowing safety record – so truthfully the shame is on you

          • Given I have been personally involved in the rigorous follow up of serious adverse events and have provided affidavits arguing that an injury is likely vaccine related I am in an excellent position to argue this is most definitely not the case. I am also involved in global vaccine safety forums solely dedicated to the most rigorous methods for assessing vaccine safety. Please refrain from ad hominum attacks and conduct any discussion respectfully. Fortunately informed consent is based on the provision of accurate science based information and not emotive anecdote.

  • Hi Nicolas,

    “I mean how do you assess the performance of this vaccine?”

    If I recall correctly, Helen has written another post that covers this. Perhaps you might like to search the blog first?

    “Seriously?? Firstly, how can you compare an age standardised death rate from cervical cancer with spontaneously reported serious adverse events per 100,000 doses of vaccine distributed and then go on to discuss risk to benefit balance??? Various types of fruit spring to mind.””

    It’s pretty simple –

    If you don’t take the vaccine the risk is of getting the cancer (leaving aside more benign effects such as warts).

    If you take the vaccine, the risk, if any, is of vaccine side effects.

    The comparison is simply the comparison of the two options.

    Easy, right?

    “I think the fact that you are so virulent goes against your point. You are a scientist, not an alcoholic at the bar.” — criticising style, not content (and with not the best tone). Blogs are best written to engage people, they’re not research papers. They’re aimed for everyone, not just scientists – including the sort that go to bars 😉 If you don’t understand this, you might like to try read a little on science communication.

    “Your constant inversion of the burden of proof is extremely unsettling.” — you give no example, empty claim.

    “Is it possible to find your conflicts of interest? Any links to PEER REVIEWED article on the topic? Your PEER REVIEWED articles on the topic?”

    All easy to find yourself if you tried. Not knowing how to find papers reflects that you’re out of your field, I think. (For papers: use PubMed. For blog author details, click on their name below the title.)

    [I write Code for life here at Sciblogs.]

    • The film was pulled from the festival because it was a load of nonsense that makes no contribution to scientific discussion. Screening it is akin to screening a film about the virtues of cigarette smoking funded, written and directed by the tobacco industry and starring Marlboro man (RIP). How helpful would that be?

    • Eruc, you are correct to question vaccine safety. It is the responsible thing to do. No one has a monopoly on medical literacy. If vaccine safety cannot be openly discussed or challenged, then something is wrong. This goes to the very heart of the informed consent process, The Precautionary Principle and the oath to First Do No Harm. For example, the HPV vaccine Gardasil. I suggest you look at the Product Monograph on this vaccine and pay particular attention to the placebos used and the adverse events reported. Note that no Ovarian studies were ever done in the clinical trials, which is of concern, given the increase in serious menstrual disorders and reproductive disturbances being experienced globally?I suggest you look up VRBPAC,( who advise the FDA,) findings on Gardasil in regard to prior exposure of HPV strains, CBER findings in 2012, on co factors in relation to the role of HPV and cervical Cancer , HPV DNA contamination in Gardasil, no recalls, no further evaluation regarding this contamination and finally, the Serious allegations of Scientific Misconduct and Malfeasance, January 2016, made in an open letter by Dr Sin Hang Lee, pathologist, to the World Health Organistion, Director General, relating to Gardasil. I doubt that many people are aware of these unresolved and unevaluated matters. For a health professional to obtain an informed consent, the client must receive disclosure of risk and benefit, in order to make an informed decision. This is a legal requirement under the NZ Bill of Rights. Personally, I know of health professionals, who admit to not knowing about these matters pertaining to the HPV vaccine Gardasil. Perhaps it is time to revise the informed consent process and who is and who is not actually informed.

  • Placebos used in Gardasil vaccine trials, as you ought to know, were not inert. WHO Gold Standards recommended for placebo in any new vaccine trial, is saline. Where saline was used in Protocol 018, theffects from this, were combined with the AAHS placebo adverse events and presented as one set of data. AAHS placebo when used alone, resulted in reports of significant adverse events. The vaccine itself, which contained AAHS, resulted in significant serious adverse events. This is a skewing of results and misleads the public and more importantly, health professionals, who obtain the consents. I know, because I have asked many of them and they admit to not knowing this and are shocked to hear this. They also admit to not knowing that no ovarian studies were carried out, which is of concern, given the serious menstrual disorders they are seeing at clinic, post Gardasil. They admit to not knowing about the HPV DNA fragments and absence of further evaluation for potential for carcinogenicity. They are unaware of VRBAC’s findings on prior exposure and its implications and CBER on HPV and cofactors. Finally, you are in no position to discredit Tomiljenovic or anyone else for that matter. I think you know what I mean by this. Have you even read the Lancet paper? Dr Wakefield did not suggest people stop using MMR. In fact he suggested continued use with single vaccines. It was the UK MOH, that prevented the use of single MMR vaccines and Merck pulling these altogether, not Dr Wakefield that stopped parents from accessing measles, mumps and rubella vaccinations.

    . Please be precise and honest when you refer to other medical experts.

    • I think these are excellent examples of common fallacies, both in logic and in fact.

      Firstly, there appears to be an assumption of guilt on my part. Generally the questions posed here are loaded.

      For example, you state that the placebo’s in a vaccine trial were not inert. Placebos are not required to be ‘inert’. In fact ‘inert’ would be very subjective. Saline is not ‘inert’. A placebo must be something that does not have a therapeutic effect. Both saline and aluminium adjuvant fulfil this requirement.

      The saline and adjuvant placebo groups were compared so that the relative contributions to injection site reactions could be compared. As the purpose of the adjuvant is to induce local inflammation at the injection site one would expect to see reactions. This is a good thing. The adjuvant group can then be compared with the vaccine group and the relative contribution of the antigen (the immunogenic component) can be assessed. Injection site reactions are, to a certain extent, desirable. The assertion that this translated to adverse events is erroneous.

      Therefore your assumptions with regard to placebos are unjustified and assume guilt on the part of the WHO, the FDA, the European Medicines Agency and the general global scientific community.

      Secondly, Attribution to a false authority, in this case both Tomiljenovic and Wakefield. Neither are qualified as experts on immunisation, in particular the matter of epidemiology. Given that their opinions are at odds with the global scientific community in this discipline (for example paediatrics, epidemiology) I think it is fair to say they are a false authority.

      Thirdly, again a presupposition, that DNA present in a vaccine is a) a revelation and b) is bad. It is neither. Of course there is fragmental DNA present in the vaccine. It is a biological. There is DNA in everything you eat and drink. There is DNA in the kisses you give and receive. You inhale DNA every day. There are absolutely no concerns with regards to harm from exposure to DNA in this context. This is a howler of a fallacy.

      Finally, the burden of proof. I would challenge you to take the responsibility for providing genuine scientific evidence for your assertions, as I have mine in the blog.

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