Here we go again.

Antivaxers don’t like vaccines. This, we know. They blame them for everything from autism to autoimmune diseases to diabetes to sudden infant death syndrome. They even sometimes claim that shaken baby syndrome is a “misdiagnosis” for vaccine injury. However, there are two vaccines that stand out above all as the objects of antivaccine scorn. the first, of course, is the MMR vaccine. That’s on Andrew Wakefield., of course, who almost singlehandedly popularized the fear that the MMR vaccine causes autism. The second most hated vaccine (by antivaxers) is Gardasil or Cervarix, both vaccines against the human papilloma virus (HPV), the virus that causes genital wart and certain subtypes of which greatly predispose to cancer. The reason for the extreme negative reaction to HPV vaccines is not because they are thought to cause autism, given that they are not administered until girls are approaching pubert. Rather, it is because they are falsely considered to be unnecessary. HPV is sexually transmitted disease, which makes the cervical cancer HPV vaccines prevent a largely sexually transmitted disease. Many religiously inclined antivaxers falsely think that HPV vaccination will encourage promiscuity, even though the evidence is pretty strong that it doesn’t. Nor does it cause premature ovarian failure or sudden death, as antivaxers frequently claim. Nor is it contaminating your precious bodily fluids with HPV DNA.

In which Orac learns of a “horrifying” review article about HPV vaccination

So it was with little surprise at all that yet another allegedly systematic review article attempting to demonstrate that HPV vaccines are not safe. (They are.) I’ve been down this road before, but I do tend to take a look when new examples of these sorts of studies roll around because I never know what I am going to find and also know that these sorts of studies tend to get shared in a rabidly viral fashion on social media by antivaxers. If I can get my take on them out before that happens, then at least there’s something out there to combat the misinformation. I didn’t quite get there in that our old buddy “Dr. Jay” Gordon posted a link to Twitter:

On the other hand, Dr. Jay did tip me off to the study. So I suppose I should thank him for that. In any case, let’s first look at how the article is being reported. The link above is to European Pharmaceutical Manufacturer (epm) a magazine that really should know better:

The study, performed by researchers from Mexico’s National Institute of Cardiology and published online in Clinical Rheumatology, identified randomised trials of HPV vaccines in PubMed and reviewed post-marketing case series highlighting serious adverse events of the vaccines.

It was found that in the majority of the randomised studies identified the control groups were not administered with an inert placebo but rather an aluminium placebo. According to a report published by Collective Evolution using an aluminium based placebos would offer up much different comparative results than when administering a pharmacologically inert placebo.

When comparing the rates of serious adverse events, the researchers found that in two of the largest randomised trials, there were more occurrences in the HPV treated groups than in the aluminium placebo groups. Additionally, comparing girls vaccinated with the 4-valent HPV vaccine and those receiving the 9-valent dose, the latter group had more serious systemic adverse events. The researchers also revealed a ‘worrisome’ quotient of the number needed to vaccinate/number needed to harm in the nine-valent HPV vaccine.

Hoo-boy. I see tropes. I see antivaccine tropes. So. Many. Tropes. Also, if you link to Collective Evolution, you lose. It’s a wretched hive of scum and quackery. Maybe not as wretched as, say Natural News, but it’s pretty bad.

Not surprisingly, it didn’t take me long to find this article by antivaccine crank Robert F. Kennedy, Jr., Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines:

A new study published in Clinical Rheumatology exposes how vaccine manufacturers used phony placebos in clinical trials to conceal a wide range of devastating risks associated with HPV vaccines. Instead of using genuine inert placebos and comparing health impacts over a number of years, as is required for most new drug approvals, Merck and GlaxoSmithKline spiked their placebos with a neurotoxic aluminum adjuvant and cut observation periods to a matter of months.

Researchers from Mexico’s National Institute of Cardiology pored over 28 studies published through January 2017—16 randomized trials and 12 post-marketing case series—pertaining to the three human papillomavirus (HPV) vaccines currently on the market globally. In their July 2017 peer-reviewed report, the authors, Manuel Martínez-Lavin and Luis Amezcua-Guerra, uncovered evidence of numerous adverse events, including life-threatening injuries, permanent disabilities, hospitalizations and deaths, reported after vaccination with GlaxoSmithKline’s bivalent Cervarix vaccine and Merck’s quadrivalent or nine-valent HPV vaccines (Gardasil and Gardasil 9). Pharmaceutical company scientists routinely dismissed, minimized or concealed those injuries using statistical gimmicks and invalid comparisons designed to diminish their relative significance.

I note that the article linked to under “invalid comparisons” was published by antivaccine activists Lucija Tomljenovic, Judy Wilyman (yes, that Judy Wilyman), Eva Vanamee, Toni Bark, and Christopher A Shaw. (More on why the comparisons are not invalid later, when I get into the article itself.)

Roll the tape: A biased, crappy “review” article designed to demonize HPV vaccines

So let’s look at the review article, which is by Manuel Martínez-Lavín and Luis Amezcua-Guerra at the National Institute of Cardiology in Mexico City. So, the first thing I wondered is: WTF is a vaccine article doing being published by Rheumatology? The second thing I wondered was: The National Institute of Cardiology in Mexico? Doing a vaccine study? It certainly is odd. The next thing I wondered was this: Who the heck are Manuel Martínez-Lavín and Luis Amezcua-Guerra? The name Manuel Martínez-Lavín seemed to ring a bell. I seem to recall having heard it before. Fortunately, almighty Google helped out. All I had to do was to search each name with “HPV,” “Gardasil,” or “Cervarix.” I immediately discovered that Martínez-Lavín is not exactly what one would call an…unbiased…source. Let’s just put it this way. When you’re approvingly cited by the antivaccine website SaneVax, a site that’s dedicated to fear mongering about Gardasil. It also turns out that Martínez-Lavín is not above doing highly dubious surveys without controls. From these, I learned that Martínez-Lavín apparently believes that HPV vaccines cause fibromyalgia, despite the lack of evidence that it does anything of the sort. Somehow I missed this horrible study, but fortunately Skeptical Raptor and Dr. Jen Gunter did not. Now, I must realize that I didn’t find much about Luis Amezcua-Guerra, but it’s not hard to see how biased the article by Manuel Martínez-Lavín and Luis Amezcua-Guerra is, even before looking at it in detail.

Let’s look at the first trope, which is a common anti-Gardasil trope that it is an inappropriate control to compare an aluminum-containing vaccine like Gardasil to an aluminum adjuvant without the actual antigens from the vaccine. The argument is that the best control should have been normal saline; i.e., an inert control. This is a profoundly ignorant argument when you have an intervention known to be safe based on many studies in many vaccines over the years (like aluminum adjuvants). When you have such an ingredient, then if you want to determine whether or not a vaccine containing that ingredient works and is safe, an excellent way to do it is to compare it to a control containing everything in the vaccine except the antigens that produce the immune response. In other words, the adjuvant-only control is a very good control. Channeling antivaccine tropes aplenty, the authors of the review try their best to convince you that the real reason this control was chosen in so many studies of Gardasil and Cervarix was to hide adverse events due to these vaccines. Of course, the existence of long term studies (like this one) comparing HPV vaccines to saline placebo controls rather undermines this particular antivaccine talking point. Basically, we have evidence from both studies comparing HPV vaccines to adjuvant-only controls and to saline controls showing that HPV is both effective and safe.

Again, go back to Lucija Tomljenovic’s paper cited earlier. That’s exactly the main claim in the paper. Let’s just put it this way, if an antivaccine crank like her makes an argument, that’s a pretty good indication that’ what’s being argued is pure, grade A BS. Of course, this is pure, grade A BS independent of Tomljenovic’s use of it. A good way of looking at it is that Tomljenovic uses it because she is an antivaxers and antivaxers gravitate to claims about vaccines that are grade A unadulterated BS. Also look at it this way: If Martínez-Lavín and Amezcua-Guerra think this is a such a compelling argument that they make it the centerpiece of their “analysis” of the randomized controlled trials (RCT) of Gardasil and Cervarix, it starts to make me question everything else in the paper. Adding to that impression is my perusal of the references, which include the works of such antivaccine “scientists” as, yes, Tomljenovic, Yehuda Shoenfeld (who just had a paper retracted), Deirdre Therese Little (who is on the board of advisors of an conservative Catholic Australian antivaccine group that preaches that Gardasil leads to promiscuity and who promotes the false message that Gardasil causes premature ovarian failure). Indeed, the paper by Little cited was deconstructed by yours truly when it came out.

Not surprisingly, this isn’t even a very good systematic or “critical” review. It’s definitely not a meta-analysis, although our intrepid authors do try to make it sound like one by “reanalyzing” data from the papers they want to try to refute. Most of them didn’t show any difference in adverse events in placebo or HPV vaccine group. There were two, however, that, according to the authors, did:

Two of the largest HPV vaccine randomized trials did find significantly more severe adverse events in the tested vaccine group vs. the comparator group: The 4-year interim follow-up VIVIANE study safety analysis compared 2881 healthy women older than 25 years injected with the bivalent HPV vaccine vs. 2871 age-matched women injected with aluminum placebo [29]. As expected in large randomized trials, both groups displayed remarkably similar baseline characteristics. General solicited symptoms during the 7-day post-vaccination period occurred more often in the HPV vaccine group (65%) than those in the control group (58%). Our calculated 2 × 2 contingency table p value was <0.01. Vaccine-related general solicited symptoms during the 7-day post-vaccination period were also more frequent after HPV vaccination (41%) than those after placebo injection (36%) p < 0.001. Fourteen deaths occurred in the vaccine group vs. three deaths in the control group (p = 0.012 by Fisher’s exact test). None of the deaths were believed to be related to vaccination. One less death was reported in the 84-month follow-up VIVIANE study, a woman diagnosed with breast cancer 6 months after the third dose of the vaccine [35]. Even after this correction, the death rate difference (13 vs. 3) remains significant (p = 0.021).

This is just plain silly. The authors are doing 2×2 contingency tables because they didn’t have the raw data, while the authors of the original VIVIANE study did and did much more sophisticated analyses. Here’s what the the actual VIVIANE study says about this:

Solicited injection-site symptoms occurred in more women in the vaccine group than in the control group (table 4). General solicited symptoms during the 7-day post-vaccination period occurred slightly more often in the vaccine group than in the control group. The incidence of unsolicited symptoms, serious adverse events, medically significant conditions, new-onset chronic disease, and new-onset autoimmune disease was similar in both groups, and pregnancy outcomes did not differ between groups (table 4). 17 deaths occurred, 14 (<1%) of 2881 women in the vaccine group and three (<1%) of 2871 in the control group; none of the deaths were believed to be related to vaccination. The independent data monitoring committee did an unblinded review of all deaths; the causes of death were very variable and no cluster of disease type was noted (appendix p 4). The mean time between the last vaccination and death was 682 days (SD 321) in the vaccine group and 496 days (424) in the control group (range 67–1191 days for both groups), suggesting no temporal relation between vaccination and death.

In other words, the difference was mainly more injection site problems, which would be expected for an active vaccine being compared to just the adjuvant. One would expect more inflammatory reactions. As for the deaths, they were analyzed by an independent data monitoring committee and showed no pattern that suggested a link to the vaccine. Taking a look at the list in the appendix should tell you that it’s unlikely there was a link (click to embiggen):

For instance, there are three suicides, one homicide (it strains credulity, even for antivaxers, to think that HPV vaccination can cause one to become a murder victim), two cases of breast cancer (both women were in their late 40s), a case of drug hypersensitivity and renal failure. You get the idea.

The authors look at another randomized double blind RCT of Gardasil that contrasted the 9-valent dose versus the quadrivalent formulation. Basically, instead of four serotypes, there are nine in the newer vaccine. I’m fed up with this “review” already; so I’m just going to cite the actual RCT:

The recipients of the 9vHPV vaccine were more likely than the recipients of the qHPV vaccine to have adverse events related to the injection site (90.7% vs. 84.9%), with the most common events (incidence ≥2%) being pain, swelling, erythema, and pruritus (Table Adverse Events.); more than 90% of these events were mild to moderate in intensity. Events of severe intensity were more common in the 9vHPV group. The frequency of systemic adverse events was generally similar in the two groups — 55.8% in the 9vHPV vaccine group and 54.9% in the qHPV vaccine group. The most common systemic adverse events related to vaccination (incidence ≥2%) were headache, pyrexia, nausea, dizziness, and fatigue. Less than 0.1% of participants discontinued study vaccination because of a vaccine-related adverse event. All the serious adverse events are listed according to system organ class in Tables S6 and S7 in the Supplementary Appendix. Pregnancy was reported in 1192 participants in the 9vHPV group and 1129 participants in the qHPV group, and information on outcomes was available for approximately 85% of these pregnancies (Table S8 in the Supplementary Appendix). The proportions of participants with live births, difficulty with delivery, spontaneous abortions, and late fetal deaths were similar in the two groups. Congenital anomalies were reported in a total of 32 infants and 9 fetuses (20 in the 9vHPV group and 21 in the qHPV group). No congenital anomaly was reported in the case of pregnancies with an estimated date of conception that was within 30 days before or after any vaccination (these pregnancies represented approximately 8% of the total number of pregnancies with known outcomes).

So basically, there were more injection site problems in the 9vHPV group, which is not surprising for a more immunogenic vaccine, and there were systemic symptoms like headache, pyrexia, nausea, dizziness, and fatigue, but clearly not that bad if only 0.1% of the participants stopped the three dose series as a result. Not understanding the concept of number needed to treat with respect to vaccines, the authors plunge boldly ahead:

The average number needed to vaccinate with the 9- valent dose to prevent one episode of the pre-specified primary end-points that would not otherwise have been prevented by the 4-valent immunization is 1757 with 95% CI ranging from 131 to infinity

That’s actually pretty damned good for a vaccine compared to another. If you vaccinate millions of women the advantage of the 9vHPV vaccine would become apparent in the form of thousands of additional cases of HPV prevented. Also remember that the 4vHPV contains the four most common types of HPV associated with cervical cancer. Adding five more types would, by definition, add less common types of HPV and produce less benefit.

And the “cover-up” continues

Finally, the authors think that the post-marketing studies are “covering up” adverse events from HPV vaccines. In their table (Table 2), they cite a whole pubnch of studies, including the one by Martínez-Lavin that I cited above that was nothing more than a questionnaire-based study in which he claims to have found an association between HPV vaccination and fibromyalgia in 45 women. They also cite—you guessed it—Tomljenovic twice, including three papers claiming to find the “ASIA syndrome” post-vaccination. It’s a syndrome so vaguely defined and (of course) not accepted by anyone other than Yehuda Shoenfeld and his fellow travelers as a legitimate medical syndrome. They also include dubious papers claiming to link Gardasil to premature ovarian failure.

The authors then go on to cite a number of postmarketing studies looking at HPV vaccine adverse events. A lot of these studies found increased incidence of syncopal symptoms (like dizziness and occasionally passing out) after vaccination. Of course, that’s why we insist that children receiving any vaccination, but Gardasil in particular (given the propensity of girls of the age receive Gardasil have syncopal episodes after blood draws and injections anyway), be observed for a while after receiving the dose. It’s not a reason not to vaccinate. Injections of all types are associated with fainting, as the authors of several of the papers note and the authors of this review do not.

A much better review of postlicensure studies of HPV vaccines by Vichnin et al found that only “syncope, and possibly skin infections were associated with vaccination in the postlicensure setting” and that serious adverse events, “such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates.”

Overall, this is a terrible systematic review. It is clearly designed to make HPV vaccination look as bad as the authors can make it look by playing up known adverse events due to HPV vaccines, such as syncope, claiming that adverse events are vastly underreported, and citing papers by antivaccine cranks as “evidence” that there are all sorts of horrible things caused by Gardasil that “They” don’t want you to know about. Not surprisingly, it’s spreading in the antivaccine crankosphere. Surprisingly, I haven’t seen it on Natural News yet. It’s coming, though. I’m sure of it.

Comments

  1. #1 Narad
    August 16, 2017

    So, the first thing I wondered is: WTF is a vaccine article doing being published by Rheumatology?

    I’m somewhat curious what it’s doing in a “journal devoted to publishing original clinical investigation and research in the general field of rheumatology with accent on clinical aspects at postgraduate level,” emphasis on the “clinical” part. (It also doesn’t appear to be indexed by Medline, but whatever.)

    An idle check of their review articles did make it seem like an outlier, at least until I noticed the “ASIA” one.

  2. #2 Dorit Reiss
    August 16, 2017

    A pediatrician on Twitter tried to claim, apparently seriously, that HPV vaccines cause suicide based on the trial results for the initial Gardasil in which there were 2 suicide/overdoses in the vaccine rates and 8 in the control group. Apparently, AAHS, in his view, causes suicide. He was unable to answer why aluminum adjuvants are so dangerous for teenage girls while they’re not to infants (he does give infants a large part of the routine schedule).

    Sigh.

  3. #3 Beth Clarkson
    August 16, 2017

    I think it is a mistake to dismiss the concern about the adjuvant-only controls versus saline placebos. I agree that, for purposes of evaluating the effect the vaccine, the adjuvant-only controls will provide the most accurate measurement. However, a parent making a decision about the vaccine is concerned with any and all problems that might result, they don’t care if the bad reaction was due to the vaccine or the adjuvent, they want to know the probability their child might have a bad reaction to getting it. That includes risks from manufacturing defects, improper administration, reactions to adjuvents, etc. Disregarding that concern and providing parents with the risks from trials with adjuvent-only controls leads to the risks of vaccination provided to parents being biased to the low side.

    • #4 Orac
      August 16, 2017

      Ah, but there are ALSO studies of Gardasil using saline controls. Also, we already know the expected rates of adverse events due to aluminum adjuvants from all the other studies of all the other vaccines with aluminum-containing adjuvants. There is not endless money to add additional arms to clinical trials or do additional clinical trials with saline controls just to assuage parental fears. These studies cost millions of dollars to carry out. It’s also incredibly unlikely that including such controls would convince you or the Gardasil fear mongerers.

  4. #5 doug
    August 16, 2017

    A recent article at CBC on the rise of the proportion of oral cancer associated with HPV remarks on the benefits of vaccination without the slightest hint of opinions against vaccination. Perhaps there is hope for reasonable journalism.

  5. #6 Beth Clarkson
    August 16, 2017

    @Orac #4 – Could you provide a link to those studies providing statistics on the expected rates of adverse events due to the aluminum adjuvants? I haven’t found them but I would be interested in seeing them. My understanding is that they aren’t included in the CDC published assessments of vaccine risks, but I could be mistaken about that. If they are included, then I’m wrong. If they are not, then parents are getting information that is biased to minimize the risks to their child of getting the vaccine.

  6. #7 Dangerous Bacon
    August 16, 2017

    Well. I don’t know how you all can be so flip about the deaths caused by Gardasil.

    There was that case of the young woman who got the Gardasil shot and then fell down a well and died weeks later. Surely you can connect the dots.

    Then there’s VAERS report #559863:

    “This spontaneous report as received from a patient”s mother refers to a 12 year old healthy female patient and was identified during social media monitoring. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (strength, route, dose, frequency and indication not provided). No concomitant medication was reported. On an unknown date, the patient died. The outcome of the event was fatal. The causality assessment was provided as related (reported as GARDASIL suspected).”

    Pretty damning, huh? Lots more like that one too.

    http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=12&PERPAGE=10&ESORT=&REVERSESORT=&VAX=%28HPV+HPV2+HPV4%29&DIED=Yes

    Thank goodness the Mexican cardiology people are brave enough to report on these “coincidences”.

  7. #8 Narad
    August 16, 2017

    Yup, Shoenfeld has also turned up in Clinical Rheumatology. Silicone is apparently now an “adjuvant,” although others seem seem to think those who “already” “have” “ASIA” are at increased risk of “silicone implant incompatibility syndrome.” Or the other way around, or both.

  8. #9 Dangerous Bacon
    August 16, 2017

    How long before the Wakefield “documentary”, The Pathological Optimist, gets released on DVD to the adulation of his antivax followers?

    http://deadline.com/2017/08/the-pathological-optimist-documentary-feature-miranda-baily-acquisition-release-date-1202148126/

  9. #10 Jay Gordon, MD, FAAP
    August 16, 2017

    This is disappointing.

    Just thinking, what if the danger from a new medication involved the interaction of various components. For instance, acetaminophen and the preservative in the med. Or what if the toxicity or side effects were actually caused by that dye or preservative? A true placebo would better highlight the problem.

    Vaccine trials need real placebos not placebos which contain one of the chemical constituents of the shot.

    And, just because the authors have well-known biases doesn’t mean we must ignore their findings. Everyone in this forum–especially the proprietor–has well-known biases. And deserves respect and attention anyway.

  10. #11 Narad
    August 16, 2017

    Just thinking, what if the danger from a new medication involved the interaction of various components.

    Then you would see it in the arm with both components. Seriously, you’re “disappointed”?

  11. #12 Rich Bly
    Ocean Shores
    August 16, 2017

    I think it was in Skylark 3 by E.E. Doc Smith where science was so advanced that scientists specialized in very narrow areas. In many areas, we have reached this level of science. There are to many scientists providing supposed research outside of their training.

    We have a paper here authored by doctors from a institute of cardiology, published in a Clinical Rheumatology publication that is about a vaccine for HPV.

    The string above seems a little out of place. I guess we’ve seen this from anti-vaxxer idiots many times before. If I have a heart attack, I am not going use dermatologist to treat it.

  12. #13 Jay Gordon, MD, FAAP
    August 16, 2017

    Narad, they did.

    “Then you would see it in the arm with both components.”

    “Seriously, you’re “disappointed?” Yes, I am. They cheated. They did not use a real placebo.

  13. #14 Rich Bly
    Ocean Shores
    August 16, 2017

    Jay Gordon, MD, FAAP, it would seem you have never actually studied how to isolate an effect of something. Think about for it for a minute. If you remove only a single component but still have adverse effects, then most likely one of the remaining component is a cause of the effect. If you remove all components, then you can determine nothing.

    • #15 Orac
      August 16, 2017

      Yeah, I’m afraid Dr. Jay has no clue what he’s talking about here. Disappointing. He also clearly doesn’t understand what is and isn’t a good control in a clinical trial.

  14. #16 Chris Hickie
    August 16, 2017

    I’ve always wondered why Jay Gordon or Bob Sears never stood up from their armchairs to actually compile data regarding whether their dangerously under vaccinated patient populations are in any way shape or form healthier than the patient populations, of, oh, say, a competent pediatrician practicing science-based medicine by following the CDC guidelines. I guess they prefer just making up untested alternate vaccine schedules and watching the measles outbreaks happen in Orange County. You would think with Jay being so smart with his “I just know” based on “personal experience” abilities that cranking out such a study would hardly tax him at all. Oh, never mind…I forgot doing this would involve actually understanding science, medicine, and statistics, which is something Gordon and Sears repeatedly show total inability to do.

  15. #17 Dangerous Bacon
    August 16, 2017

    “Just thinking, what if the danger from a new medication involved the interaction of various components.”

    Just Asking Questions, Jay? Not an improvement on your usual FAAPing.

    As long as you’re postulating, how about proposing a mechanism explaining why the “interaction” of HPV vaccine components works to cause the array of disparate ailments claimed by its detractors?

  16. #18 Chris Hickie
    August 16, 2017

    @ DB: Maybe he should change his name to JAQ Gordon, MD, FAAP.

  17. #19 Johnny
    127.0.0.1
    August 16, 2017

    Vaccine trials need real placebos not placebos which contain one of the chemical constituents of the shot.

    Jay’s right. We should use placebos that don’t have any chemicals that are present in the vaccine under test. We could replace the water component with, I dunno, brake fluid, maybe?

    Seriously, why would anybody take science from a doctor that uses homeopathy to treat ear infections?

    http://drjaygordon.com/alternative/earinfections-2.html

    I treat ear infections with prevention (anti-allergy measures such as dairy avoidance, dust reduction and getting rid of feather pillows and quilts) and with herbal and homeopathic remedies. I have some formal training in these methods but nowhere near enough to call myself an authority. I have been trained by my patients’ actions and by years of experience watching the way children respond to gentler methods of healing otitis media and other infections.

    I like to put mullein/garlic oil in the ears hourly for a day or two and give pulsatilla 6X or 12C (homeopathic strength–the range I have given indicates homeopathic ignorance… but it works) or lachesis homeopathically hourly for two days.

  18. #20 sirhcton
    August 16, 2017

    @ #8 Narad

    Shoenfeld has also turned up in Clinical Rheumatology. Silicone is apparently now an “adjuvant,” . . .

    First they came for the silicone, next they’ll come for the latex. At least after MJD gets a paper to them.

  19. #21 Dangerous Bacon
    August 16, 2017

    From the annals of “you’re biased, but what am I?”:

    “I don’t like this vaccine… Heaven help us if we have a generation of kids who get a hepatitis B vaccine and a HPV vaccine and they think that now unprotected sex is okay…”

    “I don’t think it is really clear that this vaccine is really as safe as they say it is and it is certainly not as dangerous as they say it is, but I recommend against it in my practice.”

    Dr. Jay Gordon discussing the HPV vaccine on the Ricki Lake Show

    https://vaxopedia.org/2017/07/16/is-the-hpv-vaccine-a-savior-or-the-most-dangerous-vaccine-ever-made/

  20. #22 manuel Martinez-Lavin MD
    Mexico
    August 16, 2017

    Sir: you are misrepresenting the results of our review article. We are not anti-vaxxers.
    I respectfully invite all open-minded scientists interesting in this important and controversial topic to analyze our article and reach their own conclusions.
    Science is not dogma
    Science is not name calling.

    • #23 Orac
      August 17, 2017

      Of course, I didn’t call you names. I merely criticized your article. That is not the same thing. (I may even crosspost this article on my other blog this weekend.)

      But, hey, if you think I got something SPECIFIC wrong, please tell me what it is and why you think it’s wrong. I predict that you won’t, though, because you’re confusing criticism of your ideas with criticism of you personally, and it’s so much easier to say “You’re wrong!” than it is to say WHAT is incorrect and why. Also, I have at least a couple of regular readers who are statisticians.

  21. #24 herr doktor bimler
    August 16, 2017

    Many religiously inclined antivaxers falsely think that HPV vaccination will encourage promiscuity

    And then you have the ones who pretend to believe that, and spout fetus-fondling shibboleths about abortion and promiscuity in the hope of drawing support from the Handsmaid’s-Tale theocrats (because that’s where the stupid is).
    I’m thinking of the SaneVax crowd, who are in it for the grift (with the ambulance-chasing, and Sin Hang Lee’s shonky DNA tests as a $50 mail-order service).

  22. #25 herr doktor bimler
    August 16, 2017

    Yup, Shoenfeld has also turned up in Clinical Rheumatology. Silicone is apparently now an “adjuvant,” although others seem seem to think those who “already” “have” “ASIA” are at increased risk of “silicone implant incompatibility syndrome.”

    If Shoenfeld is building a vaccine-compensation expert-testimony career on the basis of his antivax papers — as he noted in his response to that recent retraction — it would make sense to broaden his scope to silicone-implant testimony as well.

  23. #26 has
    August 16, 2017

    The National Institute of Cardiology in Mexico

    Tijuana, Mexico?

    @manuel Martinez-Lavin MD:

    🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆🦆

  24. #27 rs
    August 16, 2017

    “you are misrepresenting the results of our review article”

    Garbage in, garbage out. Therefore your results are worthless. You claim otherwise? Be specific about the misrepresentations you have so far failed to list.

  25. #28 manuel Martinez-Lavin MD
    August 16, 2017

    I thought “Science Blog” was a scientific forum. Now I see the moderator allowing unscientific, derogatory and racist remarks. My discussion ends here.

  26. #29 Chris Preston
    August 16, 2017

    Sir: you are misrepresenting the results of our review article.

    Sir, you have misrepresented the literature on safety of HPV vaccination in your review article. On first glance, you have done so because you have a bias against HPV vaccination. That would make you anti-vaccine.

    If this is not the case, perhaps you can describe what other motivation led you to misrepresent the literature on HPV vaccination in your review article.

  27. #30 Lawrence
    August 16, 2017

    Oh look, a tone troll

  28. #31 Chris Hickie
    August 16, 2017

    Dear Manuel Martinez-Lavin MD–

    Doctor to doctor, allow me to say how disappointing it was to hear you applied inappropriate formulas (basically from a biostatistics 101 class) to HPV vaccine studies employing very much more complex experimental design than you appear to understand. So instead of looking at the data properly, you just kept playing with statistical tests until you obtained a result *you* liked, which is not how you do it. However, this is entirely consistent with the behavior of other anti-vaxxers as well, such as Brian Hooker, whose statistical analyses have been even more ridiculous than yours.

    There are some very good statisticians that post here and I’m sure they could clarify the criticism of Orac if you would but listen.

  29. #32 Panacea
    August 16, 2017

    @Chris Hickie: well, one reason I can think of why Bob and Jay haven’t done any kind of clinical trial, is probably because it would become evidence of their malpractice.

  30. #33 Politicalguineapig
    August 16, 2017

    Dr. Martin Laavan: Saying ‘you’re wrong and here’s why,” is not racist. Also, if you are in an area known for quackery, there’s a high likelihood that people are going to assume you are a quack as well.

  31. #34 sadmar
    August 16, 2017

    “The Pathological Optimist, will be released theatrically by The Film Arcade on September 29th followed by a VOD release via Gravitas later this year.”

    Oh my. Given the credits of the participants, this one might actually be competent in the filmmaking/propaganda categories, capable of gaining considerably more exposure, and a bit more public traction than all the previous AV films (including Vaxxed) put together. I’d think that would depend on how wide a theatrical release it gets, and how much pub it receives. Based on the description, it takes a very different tack than previous AV films – “a complex and incisive look at this polarizing man” – rather than a straight condemnation of vaccines. I’m not sure how much this will appeal to the anti-vax core, though, as it sounds fairly subtle. It sounds very much aimed at a general audience – the sort of folks interested in dramatic character-portrait docos generally – with the AV message coming in through the back door. Basically, for this type of film to go anywhere, it needs to generate an early buzz via word of mouth and good notices from legit film reviewers. If it opens in a few theaters, and gets no more than a ho-hum, it’s likely to die on the vine in short order.

    The distributors might or might not attempt to publicize it with a strategy similar to Vaxxed: working the controversy angle and vitriolic attacks on AJW from the pro-science/vax camp for free advertising, and baiting critics into reviewing it. If it’s well done, the critics might find it “interesting” and say enough nice things about it as a story to bring other curious folks into the theaters.

    As such, I’ll suggest the less fuss made over this thing at the outset, the better. For Pete’s sake, let no one rile things up by suggesting it not be screened. Let sleeping docs lie. If and when it does catch the attention of some otherwise innocent public, take that as an opportunity to expose AJW for the callous con artist he is.

  32. #35 Science Mom
    h
    August 16, 2017

    I respectfully invite all open-minded scientists interesting in this important and controversial topic to analyze our article and reach their own conclusions.

    That is precisely what was done if you care to read the post with “an open mind”.

  33. #36 Narad
    August 17, 2017

    Adding to that impression is my perusal of the references

    Hoo, boy, check out this Shoenfeld joint. From the accepted manuscript:

    Two important case-control studies have assessed the safety of immunization practices in SLE patients and have been included in the preparation of the guidelines issued by the “Brighton Collaboration Systemic Lupus Erythematosus Working Group” [23]. An international multi-center case-control study carried out by Grimaldi-Bensouda et al. [24] between April 2008 and June 2012, involving 36 specialist referral centers (34 in France and 2 in Quebec, Canada), has investigated whether vaccination may be considered a putative risk factor for the development of SLE. For this purpose, they enrolled 105 patients with SLE: 89 with definite SLE according to the American College of Rheumatology criteria (ACR), and 16 with probable SLE meeting 3 ACR criteria, including at least 1 immunologic criterion. Further, 712 healthy controls were recruited and matched in respect to age, sex, region of residence, and date of recruitment. 22 of the 105 SLE patients (21.0%) and 181 of the 712 controls (25.4%) were found to have received at least one vaccination (e.g. diphtheria, tetanus, pertussis, poliomyelitis, influenza and hepatitis B virus or HBV) within 24 months of the index date (date of first clinical symptom) (adjusted OR or aOR 0.9 [95% confidence interval or CI 0.5–1.5]). The authors were not able to find any association between SLE and any of the potential confounding factors studied (including smoking, alcohol consumption, and family history of autoimmune disorders). The authors concluded that exposure to vaccines was not generally associated with an increased risk of developing SLE, replicating the findings of a previous study [25].

    Wait for it . . . .

    However, this case-control study was plagued by some limitations such as a relatively small sample size and the difficulty/impossibility of controlling and adjusting for further potential confounders [23].

    A second case control study by Geier et al. evaluated the association between the administration of thequadrivalent Human Papillomavirus (HPV) vaccination (HPV4, commercial name Gardasil) and autoimmune conditions reported in the vaccine adverse event reporting system (VAERS) [26] between 2006 and December 2012 among 18-39 year-old American, female subjects. The authors found that cases with SLE had an OR of 5.3 [95% CI 1.5-20.5] and, as such, were significantly more likely than controls to have received HPV4 vaccine (median onset of initial symptoms ranged from 6 to 55 days post-HPV4 vaccination). This finding was replicated by [Geier & Geier in] a following case-control study, which computed an OR of 7.626 [95% CI 3.385-19.366] for cases with SLE. In this study, the period ranged from 2006 to 2014, the population was aged from 6 to 39 years and the median onset of initial symptoms ranged from 3 to 37 days post-HPV4 vaccination [27]. However, another report [Vichnin et al.] showed that HPV4 vaccine had a high safety profile with no reported increased incidences of adverse reactions including worsening of pregnancy outcomes, anaphylaxis, stroke or certain autoimmune diseases including Guillain-Barre syndrome and multiple sclerosis, whereas in this study SLE risk of occurrence was not investigated [28].

    Of course, Vichnin et al. was a review, so I don’t know what they’re complaining about. There are at least three Geier reference entries and L-rd knows how many self-cites.

  34. #37 Daniel Corcos
    August 17, 2017

    @ Manuel Martinez-Lavin MD
    No, Respectful Insolence is not a science blog. Real scientists have no time to lose with homeopathy and acupuncture. The principle behind this blog is that Gorski can pretend that he is on the right side of science, and that all those who disagree with the message he is trying to pass are on the side of quacks. Typically the straw man argument.
    It is impossible to argue scientifically with him because he puts you in moderation. And the minions that are the most active to support his conclusions lack scientific background and critical thinking.

    • #38 Orac
      August 17, 2017

      A word of clarification for newbies, to which longtime regulars can attest: Dan is upset because I got tired of his perseverating on his pet idea here every time I wrote anything that even mentioned cancer screening in passing. It took me many months, if not years, before I finally got fed up enough with him to put him in automoderation. The comment section is better for it.

  35. #39 herr doktor bimler
    August 17, 2017

    A second case control study by Geier et al. evaluated the association between the administration of thequadrivalent Human Papillomavirus (HPV) vaccination (HPV4, commercial name Gardasil) and autoimmune conditions reported in the vaccine adverse event reporting system (VAERS)

    So the Geiers’ VAERS dumpster-diving is a “case-control study”… presumably one without the problem of “inability to control for future, purely-hypothetical confounders” that reduces the value of real research.

    OK. Got it. As long as Shoenfeld doesn’t expect people to respect him for his intellectual honesty.

  36. #40 Richard
    The Netherlands
    August 17, 2017

    @4, Orac,

    It’s also incredibly unlikely that including such controls would convince you or the Gardasil fear mongerers.

    A true word indeed, and something that can be seen in most discussions between antivaccine fanatics and people of a more scientific persuasion.
    The antivaccine crowd considers even the slightest rumor or the shakiest anecdote of ‘vaccine injury’ as reliable proof fore their point of view, yet will dismiss out of hand the very best of scientific evidence and even verifiable facts if these contradict their beliefs.
    Nevertheless, they keep claiming that their opinion can be swayed by what they consider ‘proper research’, such as massive ‘vaccinated vs. unvaccinated’ RCTs (which of course are totally unethical), or ‘real long-term effect research’ (involving 50 years of testing prior to market — yeah, right), or ‘proper follow-up’ (i.e. full physical exams with lab testing every six months or so, until adulthood) of both vaccinated and unvaccinated children.
    But as you already say, even if such ridiculously unfeasible studies or practices were actually carried out, the antivaccine crowd would still reject any outcome that contradicts their beliefs, using one or more of the universal antivaccine escape hatches, e.g. claiming that researchers are being paid by Big Pharma, or coming up with what they consider shortcomings in the research etcetera etcetera. Because They Must be Right, by definition.
    These people are the very embodiment of the term “double standard”, not to mention the H-word.

  37. #41 PutinReloaded
    Netherlands
    August 17, 2017

    “…if you want to determine whether or not a vaccine containing that ingredient works and is safe, an excellent way to do it is to compare it to a control containing everything in the vaccine except the antigens that produce the immune response.

    Tripe. That’s if you want to control the safety of the antigen alone, not of the vaccine as a WHOLE. For that you need to copare the WHOLE against a biologically inert placebo. Duh!

  38. #42 PutinReloaded
    Netherlands
    August 17, 2017

    “…It’s also incredibly unlikely that including such controls would convince you or the Gardasil fear mongerers.”

    Certainly, because it would be very likely that the adverse events would then be exposed for all to see.

  39. #43 MI Dawn
    August 17, 2017

    1. Are we sure both posts were by Dr Martinez-Lavin? If so, the flounce after 2 posts is amusing
    2. He does have a point about has’ comment. It was unnecessary.

    However, the fact that if it *was* Dr Martinez-Lavin, his total rejection of the post without any honest rebuttals – and apparently not reading the full post since he didn’t point out to any specific thing he objected to – makes me sad.

    Dr Jay: if you actually warn people away from the Gardasil vaccine, I’m very disappointed (even more so than I normally am) in you. You are doing your patients a grave disservice for when they are no longer your patients, but adults. If you actually took the TIME and EFFORT required to research the vaccines, you wouldn’t reject them. But you’d rather stand on your soapbox and proclaim how RIGHT you are.

  40. #44 MikeMa
    August 17, 2017

    Agree with MI dawn. Dr Martinez-Lavin was asked for a specific complaint by our host. Flouncing off with weeping about poor treatment and unfriendly remarks is not addressing the issue.

    One would assume from that he just doesn’t like criticism, deserved or not.

  41. #45 NumberWang
    August 17, 2017

    @Putin

    Not much point in testing the parts of the vaccine that have already been tested before…or do you check if the sky is blue everyday? You know, just in case.

    Also, if you bothered reading everything, you’d see that there ARE tests against fully inert placebos too.

  42. #46 rork
    August 17, 2017

    The same-old from a school of public health cancer statistician:

    HPV vaccine is not just about cervical cancer. Head-and-Neck cancers associated with HPV are still rising, by far the most being in men. They are not pretty, and will kill more men than cervical cancers will kill women. Then there are HPV-associated anal and penile cancers – I hope you are wincing. (In women, anal and vulva cancers are popular.)

    Get those young men vaxxed, dammit! It’ll help the women too via herd effects. This will work better than telling your kids not to touch other people’s junk ever, which will never happen.
    Uptake is still not good enough in the US. People will needlessly die and be disfigured. By Pasteur’s pancreas, we must do better.

    • #47 Orac
      August 17, 2017

      It’s true. Head and neck cancers are nasty as hell, a horrible, often highly disfiguring, way to die.

  43. #48 Lawrence
    August 17, 2017

    Wow – that’s a troll we haven’t seen for a while.

    I wonder what brought him back from the dead?

  44. #49 Julian Frost
    August 17, 2017

    In women, anal and vulva cancers are popular.

    Word choice, rork. Word choice.

  45. #50 Politicalguineapig
    August 17, 2017

    rork: “More common” might be a better word there. If you had an ability to choose cancer, I think that anal and vulva/penile cancers would be waay down the list both in terms of treatability and the ick factor.

  46. #51 Panacea
    August 17, 2017

    I had this discussion with my dentist last week, when I was getting my teeth cleaned. She wanted to use a light based screening tool for oral cancer. As my insurance covers it, I agreed as it didn’t sound risky from what she told me, though looking into later I found the evidence for it is not convincing.

    I mentioned Gardasil to her, and how it’s impacting cervical cancer rates already. Odds are, in 10 years or so HPV related cancers will become rare as more parents choose to vaccinate their kids with it. A lot of parents I’ve talked to think it’s a no brainer. The ones who don’t tend to be anti vax already.

    Anecdotally, of course.

  47. #52 JustaTech
    August 17, 2017

    has @26: Now, that’s not totally fair because there are plenty of people who live in Tijuana who will eventually need a doctor or hospital. I’m sure that there are plenty of real doctors, hospitals and clinics there. We just never hear about them because those aren’t the places that make the news.

  48. #53 Se Habla Espol
    August 18, 2017

    @has, #26: Google tells me that there’s an Instituto Nacional de Cardiología Ignacio Chávez in México City. It’s the only Institute of Cardiology I find in México, but that may be just me.

    (I tried posting this comment last night. WP claimed that I failed the ‘human’ test that I was not given the opportunity to take.)

  49. #54 Pharmacist-in-Exile
    August 19, 2017

    It seems EPM has realised the wrong turn as a search for HPV on their site retrieves “currently no content” and the provided link in this post leads to “oops, there is no such page”…

  50. #56 Dangerous Bacon
    August 20, 2017

    Gardasil and general vaccine fearmongering, with a heaping helping of anti-GMO lunacy:

    http://www.momsacrossamerica.com/it_s_not_just_vaccines

  51. #57 dingo199
    August 21, 2017

    The “Pathological Optimist”???

    Pathological Liar, more like.

  52. #58 Politicalguineapig
    August 21, 2017

    Anyone else notice the background on that “Moms Across America” blog? Classy, ladies, real classy. Also, if someone has “Zen” as a first name, it’s a pretty safe bet that 1) they weren’t born with it, 2) nothing they have to say is worth listening to.

  53. #59 Rich Bly
    Ocean Shores
    August 24, 2017

    WA DOH just released figures showing that from 2015 (56%) to 2016 (65%) of teens with HPV vaccination. 65% is still not great but a 9% jump is a good start.