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H1N1 vaccine and miscarriages: More dumpster diving in the VAERS database

Antivaccinationists just love the Vaccine Adverse Event Reporting (VAERS) database. As in love it to death. As in “can’t get enough of it.” The reason, of course, is that VAERS is a lot like an unmoderated discussion forum or, at best, a minimally moderated forum. Anyone can say anything they like. The reason is that it is a database to which anyone can add an entry, and there is only minimal effort to determine whether a given purported adverse reaction to vaccines being entered is actually the least bit likely to be even related to vaccines. Indeed, it took a man claiming that his child was turned into The Incredible Hulk before it caught the attention of VAERS staff. Moreover, it’s a database that’s been warped by antivaccine litigation, as unscrupulous lawyers encourage parents to make reports to the database implicating vaccines for their children’s autism. No wonder that antivaccine mavens like Mark Geier so love to dumpster dive in the VAERS database for spurious correlations that they can use to try to implicate vaccines as a cause of autism or other conditions, and just last week I saw that the antivaccine tradition continues as a truly incompetent researcher named Stephanie Seneff followed Mark Geier into the dumpster that is the VAERS database. Truly, for antivaccinationists, the VAERS database is a gift that keeps on giving.

And so it was just last month, when a guy named Gary Goldman decided to follow the Geiers and Seneff dumpster diving in VAERS, although he didn’t do it for correlations suggesting a correlation between vaccines and autism. Instead, he looked at a specific vaccine and tried to correlate this vaccine to miscarriages. Like the many incompetent and pseudoscientific “investigators” before him, Goldman completely misunderstood the nature of the VAERS database, particularly how it is about as excellent an example of the old computer principle of GIGO (“garbage in, garbage out”) that exists. The result is a paper published in Human & Experimental Toxicology, a rag of a journal that has published nonsense of this sort before (in fact, nonsense of this type by the very same author), entitled Comparison of VAERS fetal-loss reports during three consecutive influenza seasons Was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season?

I could save you the trouble and just point out that the answer to Goldman’s question is no, but, then, that’s not how I roll. If I had to read the study, then you’ll have to read my discussion of the study, as bad as it is. Well, actually, no one has to read this blog, and you can stop any time you like, but you and I both know that you will almost certainly follow along. Such is the power of Orac.

First, I can’t resist citing the article that first pointed me to this particular study, a post on the antivaccine website Vactruth entitled 4,250% Increase in Fetal Deaths Reported to VAERS After Flu Shot Given to Pregnant Women:

Documentation received from the National Coalition of Organized Women (NCOW) states that between 2009 and 2010 the mercury-laden combined flu vaccinations have increased Vaccine Adverse Events Reporting Systems (VAERS) fetal death reports by 4,250 percent in pregnant women. Eileen Dannemann, NCOW’s director, made abundantly clear that despite these figures being known to the Centers for Disease Control (CDC), the multiple-strain, inactivated flu vaccine containing mercury (Thimerosal) has once again been recommended to pregnant women as a safe vaccination this season.

Outraged by the CDC’s total disregard for human life, Ms. Dannemann accused the CDC of ‘willful misconduct,’ saying that they are responsible for causing the deaths of thousands of unborn babies. She stated that the CDC deliberately misled the nation’s obstetricians and gynecologists and colluded with the American Journal of Obstetrics and Gynecology (AJOG) to mislead the public by advertising the flu vaccine as a safe vaccine for pregnant women when they knew fully well that it was causing a massive spike in fetal deaths.

Wow. That’s a serious charge. Apparently so serious that Ms. Dannemann wrote a letter to Joe Mercola about it. Yes, that’s exactly the person to whom I’d go if I thought I had found a horrific threat to public health, well Joe Mercola and an antivaccinationist who defiles my home state, Mary Tocco:

To emphasize their point, on October 28, 2010, NCOW requested that Dr. Rene Tocco present their data at the CDC headquarters in Atlanta, Georgia. The CDC’s Dr. Shimabakuru gave a presentation on significant adverse reactions to the H1N1 vaccine, such as cases of Guillane-Barre Syndrome, which appeared to have risen three percent, claiming it as an insignificant signal.

And now there’s Goldman’s “study.” I hesitate to dig in, as bad science always gives me indigestion, but it’s my chosen avocation to look at pseudoscientific claims such as this. In the introduction, Goldman spends considerable time discussing a study by Moro et al that looked at the question of whether there was an increase in reports of adverse events in VAERS associated with the H1N1 vaccine during the year when it was feared that there would be a pandemic (2009-2010 flu season). Contrary to what you might think, it was a study that failed to identify any concerning patterns of fetal loss associated with the H1N1 vaccines. Specifically, the authors concluded, “Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.” Of course, Moro et al suffers from the same GIGO problem that Goldman’s paper does, but at least the authors recognized that VAERS is an early warning system and that it’s a system not designed to be an accurate reflection of incidence of various adverse events associated with vaccination. It also can’t demonstrate causality. Be that as it may, Moro et al identified features associated with spontaneous abortions and stillbirths, and found the usual suspects: advanced maternal age, smoking, history of intrauterine fetal death (i.e., previous stillbirth), and the like, leading Moro et al to observe about spontaneous abortion (SAB) after vaccination:

SAB is a relatively frequent event in pregnancy, with a rate as high as 22.4% in women aged 34 years old or older and 10.4% in women younger than age 25 years.27 Stillbirths occur at a background rate of 0.4% of all pregnancies or 6.22 per 1000 live births and fetal deaths.30 There is underreporting to VAERS in general, and the proportion of AEs following immunization among pregnant women that are reported to VAERS is unknown. Nonetheless, the reporting rates to VAERS for SABs and stillbirths after H1N1 vaccine was several orders of magnitude lower than the expected rates of fetal losses in the general population of pregnant women [27] and [30] during a time of heightened awareness about vaccine safety.

The VAERS data provide no indication that the occurrence of SABs and stillbirths following influenza vaccination is higher than in the general population.

None of this stops our intrepid antivaccine researcher from cherry picking statements from Moro et al, using them to imply that there is a horrible problem, and then diving right into the VAERS database in a swan dive into the muck, “bravely” asking the question of whether there’s some sort of “synergistic toxicity” between the H1N1 vaccine and the seasonal influenza vaccine that was given in addition to the H1N1 vaccine during the 2009-2010 flu season. Basically, Goldman looked at fetal loss reports in the VAERS database for the two-vaccine 2009/2010 influenza season compared with reports from the immediately prior (2008/2009) and subsequent (2010/2011) single-vaccine seasons. Goldman then used VAERS and another “independent” data source from a group called the National Coalition of Organized Women (NCOW), who administered an Internet survey:

An independent survey was conducted by the National Coalition of Organized Women (NCOW) via the Internet to serve as a second surveillance source for pregnant women suffering A-H1N1 fetal loss during the two-vaccine 2009/2010 influenza season. Eileen Dannemann, director of NCOW, oversaw this study and the data collected are summarized in the Results section. In response to a public service announcement delivered via several websites on the Internet, respondents contacted one of two study coordinators via phone or e-mail address. The respondents provided relevant details including (a) type of influenza vaccine received, (b) date of vaccination, (c) type of vaccine, (d) date of onset of symptom/symptoms, (e) date of SAB or miscarriage, (f) geographic location, (g) whether or not the AE was reported to VAERS, and (h) other miscellaneous comments.

There’s so much wrong here that it’s tempting to stop right here and point out that, no matter what Goldman found, it’s almost certainly a pair of fetid, stinking dingo’s kidneys. What Goldman has done is to take two sources, one a passive surveillance system prone to reporting biases (both over- and underreporting) that can’t be used to estimate incidence or prevalence, the other an internet survey performed by an advocacy group, and combine them. Somehow he expects that from these sources he can come up with a halfway reliable estimate of the incidence of spontaneous abortion and stillbirth after vaccines, compare it to data from other sources for total number of pregnancies, H1N1 and seasonal flu vaccine uptake, and then use this gmish of data sources to prove that the H1N1 vaccine adds some sort of synergistic toxicity to the seasonal flu vaccine. And, to top it off, he seems to think he can do it accurately for three different flu seasons. Surprise, surprise, he can’t! None of this stops Goldman from “finding” a massive increase in reports of fetal loss during the 2009/2010 flu season. Per Goldman, although there was a four-fold increase in pregnant women vaccinated in 2009/2010 compared to the previous year, there was a 43.5-fold increase in fetal loss reports. Of course, this all assumes that you can use VAERS or an Internet survey to produce a reliable estimate an actual population incidence of an adverse reaction.

You can’t, but Goldman labors mightily to convince you that you can, although one can’t help but note that in the 2010/2011 flu season the H1N1 vaccine was combined with the seasonal flu vaccine. If there were “synergistic toxicity,” we would expect to see it in the 2010/2011 flu season. We don’t. Goldman tries to convince readers that there isn’t a massive reporting bias, despite all the hype and the antivaccine movement going into high gear by looking at the reports of anaphylaxis and noting that they were only elevated by around 10%. Of course, during hte 2009/2010 flu season, anaphylaxis wasn’t what the antivaccine movement stoked fears about. Miscarriages in pregnant women and Guillain-Barre syndrome were. For instance, this story and this video, both from the 2009 flu season:

Then there’s NCOW itself. Here’s an interview with Eileen Dannemann, in which NCOW is described as the “grandmother of many of the anti-GMO coalitions.” As I’ve pointed out many times before, anti-GMO often goes together with antivaccine, and it turns out that this rule of thumb applies quite well to NCOW. Together with Leland Lehrman, Dannemann co-founded the Progressive Convergence. Now click on the link for Progressive Convergence. What do you see? I see a banner urging readers to join the Vaccine Liberation Army, features an antivaccine flier. There’s even a whole section on vaccines that includes every major antivaccine trope in the book, including blaming vaccines for shaken baby syndrome (the vilest lie of all), links to studies by mercury militia founding members and antivaccine warriors extraordinaire, Mark and David Geier (just search this blog using “Mark Geier” for examples of how bad research can be), and a page with links to a wide variety of very bad antivaccine studies (are there any kind?), many of which I’ve blogged about on this very blog over the last eight years provided by Mark and David Geier themselves!

So let’s see. One of Goldman’s data sources is an report based on an Internet survey by a rabidly antivaccine group that frightens pregnant women about vaccines, in particular the flu vaccine, and even more particularly the H1N1 vaccine during the H1N1 pandemic in 2009-2010. It was, as far as I can tell, never published in the peer-reviewed literature, and was a very shoddy analysis. It’s also a data source in which he features prominently. Then there are whole Internet communities that were pushing the H1N1-SAB link, including on that “mother of all” antivaccine mother communities, Mothering.com, where claims that the H1N1 vaccine causes miscarriages were given wide publicity in the community. Moreover, miscarriages are, unfortunately, very common. Indeed, Steve Novella estimated:

There are about 4.2 million births a year in the US. About 15-20% of pregnancies result in spontaneous abortion (miscarriage or stillbirth). Even if we take the lower number, that’s 700,000 spontaneous abortions per year, or 58,000 per month. This means that over the two months of the vaccine program in 2009-2010, 116,000 women in the US would have had a spontaneous abortion. Half of them were vaccinated. Let’s further say that half of those vaccinated had their miscarriage or stillbirth after they were vaccinated – this leaves us with about 29 thousand woman who had spontaneous abortions following getting the H1N1 vaccine last season – just as the background rate.

So King’s estimates, based upon wild extrapolation from a few hundred reported cases, is still short of the background rate by an order of magnitude.

It’s the same principle by which antivaccinationists try to blame vaccination for autism. There is a large number of children every year in whom the first symptoms of autism are noticed after vaccination. Unless one controls for this background rate and demonstrates that there is a higher risk of autism after vaccination than just the background rate of diagnoses per time period normally observed in the population, you can’t say there’s an increased risk of autism after vaccination. The same holds true for miscarriages, but is even more difficult given the even larger number of miscarriages. After all, only around 1% of children are diagnosed with autism or autism spectrum disorder, while around 15-20% of all pregnancies end in miscarriage. Now, as then, Goldman and NCOW do not correct for this, and, quite frankly, even if they did you still can’t accurately estimate adverse reaction incidence from VAERS. Making such estimates rests on a chain of assumptions and the use of multiple data sets. Also, given that Goldman used two different data sources, one wonders if he corrected for double-counting (miscarriages counted both in VAERS and in NCOW’s report). If he did, I don’t see it.

The bottom line is that Goldman’s “study” is an absolutely atrocious bit of egregious antivaccine nonsense designed to frighten pregnant women into refusing the flu vaccine. It boggles that mind that such dreck can pass peer review and be published in an ostensibly peer-reviewed journal. That it was says a lot more about the journal than whether vaccines cause miscarriages. It also goes to show that there are journals out there that could easily go out of business and not be missed in the least—except by cranks and pseudoscientists.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

235 replies on “H1N1 vaccine and miscarriages: More dumpster diving in the VAERS database”

The likes of Goldman love VAERS because they can use it to play to their base and also pretend they are conducting research. Hacks like Goldman can simply sit at their computers and generate histrionic drivel which he has done previously with vaccines and infant mortality. Sadly, there are bottom-feeding journals that allow them a stage.

NCOW? Gotta love it! Best acronym.
-btw- Null will be premiering his anti-GMO documentary next week. So expect repercussions throughout the woo-esphere… they feed off of each other.

@ AoA:
Handley is back again perseverating on the unvaccinated study and he has somehow managed to work Nate Silver** into his rant… ah, Nate, seems everyone wants a piece ( that doesn’t sound right, does it?) You know what I mean.

** as in well, economic indicators have been wrong so vaccination is wrong. Don’t trust experts. Oh lord, I’ve heard that one before.

Makes me feel like I should submit a report to VAERS myself. In Dec 2009, I received the flu shot and the H1N1 shot (mine were separate then, so the combo must not have come in yet?). In January 2010, I got an update on my tetanus/diptheria/pertussis. In October 2010, I gave birth to a very healthy baby girl who is now a very healthy child. Vaccines: for healthy babies.

I have a question about the decision to remove thimerosol from childhood vaccines. Was it due to concerns that the panic would lead people to not vaccinate, was it because they found a better preserving (?) agent, or was it for some combination or third reason?

I really need to go up to Employee Health and get my flu shot today.

Still wondering what I should report to VAERS. Odd dream about having to repeat 4th grade? Mid-week craving for a margarita? A third arm?

A week after I received a vaccine, I was in an extreme- hipster area with friends: one of them asked me to come over to where he was, so I could read a restaurant’s menu in their window ( it was in a foreign language)- so I did, and catching my shoe’s heel in a broken pavement, fell down, injuring myself slightly.
Thus, as anti-vaxxers say, most vaccine injuries go unreported.

In January 2010, I got an update on my tetanus/diptheria/pertussis. In October 2010, I gave birth to a very healthy baby girl who is now a very healthy child.

Vaccines can make you pregnant? Alert the media!

Goldman and his ilk forget that, if there were such a ‘synergistic’ effect from vaccinations, the VSD would have picked up on it already during their surveillance.

I guess reality isn’t his strong suit.

One interesting calculation is to ask what it would imply if the supposed 43-fold increase were real. With the base rate of 116,000 over those two months, simple multiplication gives us a figure of a bit over 5 million miscarriages.

With 4.2 million births per year, divided by 0.85 to account for the base miscarriage rate, and multiplied by 0.75 because each birth accounts for about three-quarters of a pregnancy-year, we get a [i]very[/i] crude estimate of 3.7 million pregnancies at a time. If half of those women got vaccinated, we come out to a bit under 2 million pregnant vaccinees.

Conclusion – each pregnant woman who received the H1N1 vaccine had 2.5 miscarriages because of it. (Alternatively, every pregnant woman miscarried, even those not vaccinated.) Yet nobody noticed without VAERS trawling. Um, I don’t think so.

I am reminded of the graph that predicted the autism prevalence would exceed 100% in the near future.

Hmmm….several years ago I was in a treatment program for recurrent miscarriages, overseen by an internationally renowned expert in reproductive immunology and autoimmune diseases who has been studying unexplained miscarriages for several decades. When he explained their findings so far and the recommended therapies, guess what was never mentioned? VACCINES! It’s almost like there’s no reason to believe vaccines have anything to do with miscarriages. I wonder how his team missed that??[/sarcasm].

The number of births in the US was rising from 2006 – 2008, and fell in 2009 and 2010. One could argue that that corresponds to the confidence in the economic future, but the coincidental flu vaccine change is so much jucier.

There’s a persistent troll who kept posting direct quotes from Goldman’s Simpsonwood screed…except “vaccineshurtkids” keeps referring to it as Simpson wood. “vhk” also mentions the separate H1N1 vaccine given during the 2009-2010 season flu season and numbers of miscarriages associated with the H1N1 vaccine.

http://www.forbes.com/sites/emilywillingham/2012/11/21/will-science-be-in-attendance-at-latest-congressional-autism-hearing/

He’s unable to answer why there isn’t a dramatic increase in miscarriages reported during subsequent years, when the H1N1 strain was incorporated into every seasonal flu vaccine (2010-2011, 2011-2012 and 2012-2013).

I’ve linked a number of studies for the troll, using the VAERS and the VSD systems and their is no increase (above baseline) in miscarriages or adverse fetal outcomes:

http://www.cdc.gov/flu/protect/vaccine/qa_vacpregnant.htm#what4

“What do studies show about pregnant women and the safety of last year’s flu vaccine?

Considerable efforts were made to study the safety of vaccinating pregnant women with the seasonal flu vaccine during 2010-2011. There were no signals or safety concerns identified in pregnant women who received the seasonal flu vaccine during this period.”

(There are additional studies about the safety of seasonal flu vaccine published in a recent ACOG Journal, that I also linked to, for the troll)

There is good news. Due to Willingham and Sullivan at LBRB blogging about the Congressional Hearing set for tomorrow at 2 PM, two additional scheduled speakers who are autistic and who are pro-vaccine, will be speaking.

I received 3 different vaccines in the past 4 months and I can’t recall any adverse reactions. Vaccine-induced memory loss.

I got the separate H1N1 vaccine, January 2010 and have received each seasonal flu vaccine that contained the H1N1 strain, since then….and I never had a miscarriage.

Here’s a study conducted using Swedish Birth birth records for women who received the Pandemrix (H1N1) vaccine during their pregnancy (full article is available for free)

http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2012.03470.x/abstract

Källén B, Olausson P. Vaccination against H1N1 influenza with Pandemrix® during pregnancy and delivery outcome: a Swedish register study. BJOG 2012;119:1583–1590.

Objective  To describe a large study on pregnancy outcome after vaccination against H1N1 during the 2009/10 pandemic.

Design  A cohort study of women vaccinated with Pandemrix® during pregnancy.

Setting  The Swedish Medical Birth Register was used for the analysis. Information on vaccination and pregnancy week when vaccination was made was obtained from antenatal care documents.

Population  All women who gave birth during 2009 and 2010 in Sweden.

Methods  Characteristics of the vaccinated women and their delivery outcome were compared with two groups of women: women without a known vaccination who gave birth in 2009/10 after 1 October 2009, and women who gave birth during 2009 before 1 October. Adjustment was made for year of delivery, maternal age, parity, smoking habits and body mass index.

Outcome measures  Stillbirth, congenital malformations, preterm birth, low birthweight, small for gestational age.

Results  A total of 18 612 vaccinated women having 18 844 infants were studied. The risk for stillbirth, preterm birth and low birthweight was lower than in the comparison groups whereas the risk for small for gestational age and a congenital malformation (after vaccination during the first trimester) did not differ from the comparison groups. No clear-cut explanation to the ‘protective’ effect of vaccination was found.

Conclusions  Vaccination during pregnancy with Pandemrix® appeared to have no ill effects on the pregnancy. On the contrary, the rate of preterm birth and low birthweight was lower than expected, which agrees with some previous results.

I suspect AoA’s use of N. Silver’s name is because he’s getting a lot of hits on the search engines. AoA appears to make a habit of doing that. We should keep an eye on top google hits and see if any of them end up in an AoA headline.

It’s also asking for money. How charming.

http://jeevankuruvilla.blogspot.com/2012/11/experience-with-rsby-5.html

For those not familiar with Dr. Kuruvilla’s The Learner blog, he runs a charitable hospital in rural India and blogs about it. He notes problems with the hodge podge of medical services, which include everything from spiritual healers to barely trained lay persons to mercenaries who offer various services including prescription medications without a prescription. We aren’t talking opiates, but antibiotics, antimalarials to apparent intramuscular injections of pitocin to “help” laboring women.

In this post he details three cases where such “treatments” ended up being quite costly – not just to the families, but the government program meant to provide healthcare to the poor.

@AllieP

I have a question about the decision to remove thimerosol from childhood vaccines. Was it due to concerns that the panic would lead people to not vaccinate, was it because they found a better preserving (?) agent, or was it for some combination or third reason?

At the time, there was not a lot of published research on thimerosal. Largely due to the precautionary principle, as well as lots of political pressure, FDA recommended to manufacturers that they remove thimerosal from childhood vaccines. This was relatively easy to do, since we have the technology and resources to create single-dose vials and prefilled syringes.

There weren’t any alternative preservatives that replaced it. There was no evidence showing that it was hazardous.

Surveillance bias. Surveillance bias. Surveillance bias.

Part of calling yourself a “researcher” and publishing your “studies” is to understand the limitations of your studies and even discuss them in your presentations, papers, or posters. The biggest limitation to VAERS is surveillance bias. In short, the more you look for something, the more of it you’re going to find.

So the government set up VAERS to look for vaccine adverse reactions and, guess what, they found them! But none of these so-called “researchers” that keep dumpster diving into VAERS discuss this bias, let alone any other bias. They are being intellectually dishonest, and the people who follow them seem to be okay with being lied to.

It boggles the mind.

Anyway, a good commentary on surveillance bias is here: http://jama.jamanetwork.com/article.aspx?articleid=900883

Forgot to mention this earlier, but Ren’s comment reminded. That survey by NCOW had another glaring flaw: selection bias. It’s hard to say without looking at the actual survey, but it seems the participants are self-selected. Those who had a miscarriage at some point following immunization and suspect the vaccine was to blame would be more likely to participate than those who didn’t miscarry or who miscarried at some point before being immunized. Also, if the survey was advertised primarily on web sites sharing an anti-vaccine viewpoint, that further skews the selection bias in the sampling.

Just throwing this out there, but isn’t VAERS capable of allowing multiple submissions? it’s pretty tough to control over reporting in a system such as that. After playing around with it, VAERS seems to let me submit multiple times for these things.

Beamup:

Conclusion – each pregnant woman who received the H1N1 vaccine had 2.5 miscarriages because of it. (Alternatively, every pregnant woman miscarried, even those not vaccinated.) Yet nobody noticed without VAERS trawling. Um, I don’t think so.

That was what immediately struck me too. The figure of a %4250 increase is completely and utterly absurd.

Ugh, that is a very familiar bit I read about almost two years ago. Some guy, Mark, kept pushing Eileen Dannemann’s “research”, but flat out refused to produce any information about her educational background. He also listed as his website “Global Political Awakening”, which is about as bad (or worse) than “Progressive Convergence.”

Here’s a study conducted using Swedish Birth birth records for women who received the Pandemrix (H1N1) vaccine during their pregnancy (full article is available for free)

http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2012.03470.x/abstract

Källén B, Olausson P. Vaccination against H1N1 influenza with Pandemrix® during pregnancy and delivery outcome: a Swedish register study. BJOG 2012;119:1583–1590.

Lilady, didn’t you notice that this study was from Sweden? That means it might as well be Danish. And that both authors have names that end in a syllable vaguely like the last syllable in “Thorsen”?

Clearly this study is utter garbage.
Jake Crosby will easily confirm this for you and verify my analytical methodology.

Ren

They are being intellectually dishonest, and the people who follow them seem to be okay with being lied to.

That was my immediate reaction – don’t these people care that this is obviously untrue? I’m still confused by this. I’ve seen this so many times on alternative health blogs and discussion groups, and here too: someone makes a ludicrous claim, that there are no vaccine safety studies for example, someone else shows them that there are thousands, they go quiet for a while and then come back making the same stupid claims. I don’t really understand that mentality. Does the truth not matter to them or are they true believers to such a degree it doesn’t penetrate their consciousness?

Oooh, thanks for warning me dingo199.

I’d really be *upset* if he came posting here to *challenge me* about that Danish study. 🙂

BTW, I’ve just posted twice at the sockie on the SOP blog.

@Dingo

You have to read the study to us. Using the a “Swedish Chef accent”

Hiir yu haf da needil. See da needil? Der it is. Soo you take-a da needil og stickity da needil in da arm!

And, after posting that comment….

“Using the a” WTF?

G’night. Clear sign I need to sleep.

I got a very nice H1N1 vaccine at the beginning of September. It came from a multi-dose vial, complete with thimerosal, and was administered by a very nice pharmacist at Target with an extra-fine needle. I got a Batman bandaid and a $10 Target gift card. I don’t remember any adverse reactions, but I was miffed when my employer’s insurance company has completely reversed policy on flu shots, and will pay for them in full. They emailed us 2 months after I paid for mine. I consider that a delayed adverse reaction, and I will report it in VAERS.

I feel slightly guilty in that I outright laughed at this.
The only disappointment was AoA didn’t have a mention in the post.

I note that one of our posters confesses to being a newt.

I’m lucky I’m a frog.

So at least I stand a chance of turning into a prince.

I know this because I’m going to post it on Vaers (sp, I’m doing this from my mobile)

Looking at the video. Truther girls. Anyone else think it’s pathetic and rather demeaning that grown women call themselves girls?
Of course, that’s not all that’s wrong with it but my codeine addled brain just can’t cope!

@ Autismum:

How about those who go by ‘nyms like ‘Princess’,
‘ Cupcake’, ‘Snap’, ‘Booty Kicker’, ‘Sugah’, ‘Professor’, ‘Mountain Mama’ et al?
( Thinking Moms Revolution)
I suppose it beats “Posh’, ‘Sporty’, ‘Scary’ etc.

-btw- Codeine? I assume you’re ill or injured**… get well soon.

** you’re not the type for recreational usage I venture.

The Truther Girls are a hoot. Protip: Making a rambling eight-minute video about lithium in the water supply kind of gives the gig away.

Denice Walter – those ‘nyms are icky. Mind you, Autismum is pretty terrible.
The Codeine is for an old injury come back after trying to keep up with a certain 4 year old
(btw this is me if I get stuck in moderation for changing my e-mail address – just want to be a pinkamingo again)

@ Autismum: I like your ‘nym. The Pwd is a handful…but so adorable.

Hope you make a speedy recovery. 🙂

I suppose it beats “Posh’, ‘Sporty’, ‘Scary’ etc.

I never thought I would find myself defending the Spice Girls on a science blog, but I must point out that their silly names were part of a mind-bogglingly successful marketing strategy:

The group became one of the most successful marketing engines ever, with their global grosses estimated at $500–800 million between 1996 and 1998 and the group earning up to $75 million per year.

I’d change my name to ‘Princess’ in a flash for $800 million!

Autismum, I like your featherstone flamingo. Better than a dog, even one with superpowers.

*http://en.wikipedia.org/wiki/The_Bridge_(Danish/Swedish_TV_series)

**http://www.youtube.com/watch?v=RhRkAzaDuyg

@ Krebiozen:

I’m not sure that Princess would work for you.

Since this is the internet, perhaps we should all make up ‘nyms and be trendy. Oh wait.
I could be All Court Player. Which I have been actually labelled by One Who Should Know ( tennis pro).

@ Grant:
Wow, you changed species!

For the record, there is a serious analysis of VAERS by Moro, et al (Expert Rev Vaccines, 2012; 11(8):911-21. Also the National Vaccine Advisory Committee had active surveillance of the safety of the 2009 monovalent vaccine for pregnant women (through the VSD, among other places). The results were publicly reported as showing no association with adverse pregnancy outcome, as NCOW knows, as they were at the meetings by phone.
As an aside, the organization’s name is an unfortunate example of not looking at the acronym before finallizing the title.

While the 2010/11 Influenza Vaccine was formulated with the H1N1 strain, the vaccine was administered as a single dose; whereas, in 2009/10 two separate influenza vaccines–each containing Thimerosal–were utilized, thus the synergistic effect observed during the 2010/11 season.

A study using different methodology, but supporting the same conclusion is:
Toxicological & Environmental Chemistry
Maternal transfer of mercury to the developing embryo/fetus: is there a safe level?
DOI: 10.1080/02772248.2012.724574
Ian A. Browna* & David W. Austinb
Abstract:
Mercury (Hg) exposure is ubiquitous in modern society via vaccines, fish/crustacea, dental amalgam, food, water, and the atmosphere. This article examines Hg exposure in the context of primary exposure to pregnant women and secondary exposure experienced by their unborn babies. Babies in utero are particularly at risk of higher Hg exposure than adults (on a dose/weight basis through maternal Hg transfer via the placenta), and are more susceptible to adverse effects from mercury and its biologically active compounds. It is, therefore, critical that regulatory advisories around maximum safe Hg exposures account for pregnant women and secondary exposure that children in utero experience. This study focused on standardized embryonic and fetal Hg exposures via primary exposure to the pregnant mother of two common Hg sources (dietary fish and parenteral vaccines). Data demonstrated that Hg exposures, particularly during the first trimester of pregnancy, at well-established dose/weight ratios produced severe damage to humans including death. In light of research suggestive of a mercuric risk factor for childhood conditions such as tic disorders, cerebral palsy, and autism, it is essential that Hg advisories account for secondary prenatal human exposures.

Please correct second reference to 2010/11 to 2009/10 at the end of the first paragraph.

Thank you…

Mr. Goldman, do you not understand there is a difference between methylmercury and ethylmercury? Also, that there is a vast difference between the number of mercury atoms in the dose of thimerosal used in influenza vaccines?

Or that in 2009 there were thimerosal free influenza doses, plus there are several states that prohibit children and pregnant women from receiving vaccines with thimerosal. Which caused a bit of a crisis since there higher fatalities among those two demographics.

And your comment in no way lets you get out of the very bad VAERS dumpster diving, and the use of a self-selected survey. Did you even research the rate of miscarriages that normally occur? You might have known about bias in surveys if you had actually attended an accredited university for graduate school. But it looks like you have not taken even the freshman level course in statistics.

Ian A. Browna* & David W. Austinb

Ah, yes, “Browna* & Austinb.” Where’s your computer-science degree from, Gary? Competent use of “cut” and “paste” is usually covered before the postsecondary level.

Oh, wait… oh, no *SNORT*… it can’t *GASP* be… nononono, STOP, PLEASE… PACIFIC WESTERN UNIVERSITY? BWAAAHAHA, AAAH, AAAAAAH, NO MORE.

Ian A. Browna* & David W. Austinb

Copy-paste is more impressive if you remove the superscripts and footnotes.

the synergistic effect
Synergy? What is supposed to be producing a super-additive interaction with what?

It is amusing that Mr. Goldman did not even mention the substance of this article: “What Goldman has done is to take two sources, one a passive surveillance system prone to reporting biases (both over- and underreporting) that can’t be used to estimate incidence or prevalence, the other an internet survey performed by an advocacy group, and combine them. ”

The use of the online survey is the most laughable. The quality of types of surveys are covered in the first chapter of a beginning statistics course. This is why we know votes a website or to a television program are not scientific.

Ha, I knew he would show up here; he gets his fee fees hurt whenever his desktop drek gets slammed. Stop publishing such target-rich rubbish then.

While the 2010/11 Influenza Vaccine was formulated with the H1N1 strain, the vaccine was administered as a single dose; whereas, in 2009/10 two separate influenza vaccines–each containing Thimerosal–were utilized, thus the synergistic effect observed during the 2010/11 season.

What synergistic effect was observed Goldman? The one you just pulled from your nether region? You can’t even say which women received a TCV which any first year epi grad student could tell you is a basic premise to establish.

Narad, isn’t Pacific Western Uni one of those defunct diploma mills?

The Cochrane Summaries is viewed by many to be the gold standard when it comes to interpreting studies related to medicine. Even current chairmen of the CDC’s Advisory Committee of Immunization Practices (ACIP), Jonathan Temte, MD, has quoted some of their studies when making his presentation advocating health care worker influenza vaccination. In 2010 the Cochrane summaries determined influenza vaccination in healthy adults had only a modest benefit in reducing your chances of missing work due to the flu, and “insufficient evidence” to reach conclusions on effects on hospital admission rates or complications (http://www.ncbi.nlm.nih.gov/pubmed/17443504). Another Cochrane review determined that there is no evidence influenza vaccination had any benefit of preventing transmission from HCWs to the elderly in long-term care facilities (http://www.ncbi.nlm.nih.gov/pubmed/20166073). It’s reasonable to extrapolate that the elderly in LTCFs are not much less vulnerable than the elderly in hospitals.

Ironically, or maybe not, the CDC is known to evaluate private studies that get printed in journals that are heavily subsidized by drug companies. Cochrane looks at public studies as well and has identified a bias in the sort of studies the CDC included in its analysis. But would a HCW want to be a recipient of an injectable vaccine because the CDC cherry picks favorable studies while ignoring ones showing no benefit?

Ignoring confounders. Influenza is clearly harder on the very young and the very old. What those two populations have in common is the propensity for a weakened immune system. Weight control, diet, 25-hydroxyvitamin D levels, sleep habits, exercise and more impact one’s immune health and to not factor these variables into studies renders such weak in their import.

The ethical obligation argument. Name a hospital that requires visitors to show yearly proof of influenza vaccination? There probably isn’t one and no one has brought forth evidence to the contrary. If the concern is for the well-being of health care personnel and patients why are HCWs on the wrong side of the line of discrimination? This speaks to the credibility argument made at the outset.

Adam,

In very broad terms, there are certain activities where vaccinations are mandatory, though often there are exemptions for medical and other reasons. Generally they’re mandatory for:
– health care workers, as required as a condition of employment
– children congregating together in numbers, such as schools or daycare facilities
– people travelling into/out of areas where particular diseases are endemic

The rules and requirements vary significantly from place to place.

They are required in these situations in order to protect the lives and health of the group of people involved. This includes both the individual and the surrounding population. Immunizations are typically required for diseases that spread easily and rapidly and which have known rates of adverse effects that make it desirable that these diseases not spread. Additionally, the known incidence of adverse affects from the vaccine is generally orders of magnitude lower than for the actual disease.

So why require it? Because the more people are immunized, the less likely a disease is to spread. This is particularly important for those who have not yet been immunized or cannot be immunized for medical reasons. It is also important because no immunization is 100% effective over the course of a life. Not everyone who is treated will develop an immunity; not every immune reaction will be sufficiently strong to ensure the person is not susceptible; and immunization can wear off over time. By ensuring that people who go into contact with groups are immunized, this reduces the pool of people who will harbor and spread the disease.

One might argue that this is an individual decision; a matter of free choice, with the person’s decision (or their legal guardian’s) whether to assume the risk. This would be the lottery ticket view – if I choose to buy or not buy a lottery ticket and take the chance, what is it to society? However, this is more in the nature of following fire codes – the community as a whole has an interest in ensuring that fire (or disease) does not spread. Your decision to vaccinate or not has consequences for the people you are in immediate contact with and, by extension, to the community at large.

Hope that helps.

Adam:

It’s a very simple question in the field of freedom of choice, right?

I object to someone claiming “freedom of choice” when it endangers others.

Just as folks are not “free” to smoke tobacco anywhere they want, nor are they “free” to drive drunk: a parent should not take advantage of the public education and be “free” to send a child who is incubating measles, mumps, pertussis, chicken pox, etc. to school. Especially since those can be prevented by vaccination, which has been shown to be much safer than any of those diseases.

Your “freedom of choice” does not include being a parasite on society by leaching off of herd immunity. You are welcome to not vaccinate your children, but don’t enroll them in a school. Teach them at home. Or start your own parochial “Church of the Special Little Snowflake School.”

So, Scott has no original thoughts about Mr. Goldman’s very bad use of statistics with biased survey methods? I am not surprised.

The reason, of course, is that VAERS is a lot like an unmoderated discussion forum or, at best, a minimally moderated forum
The 4chan of epidemiology, if you will.

Scott

Influenza is clearly harder on the very young and the very old. What those two populations have in common is the propensity for a weakened immune system. Weight control, diet, 25-hydroxyvitamin D levels, sleep habits, exercise and more impact one’s immune health and to not factor these variables into studies renders such weak in their import.

Please explain to me the impact of weight control/diet, sleep habits, and exercise on the average infant or toddler (i.e., the very young). Most small children eat and sleep just as much as they need to. And they run around a lot. They’re not the sitting around on the night shift feasting on fast food.

If those all things are so important, why is influenza so hard on the very young?

Since its inception, VAERS has been used an an “indicator” of potential deleterious effects and has been used by many researchers to prove safety of vaccines. Consider the yearly VAERS reports of fetal losses following influenza vaccine:
1,0,1,1,0,1,1,1,1,1,0,1,1,1,1,1,1,1,1,4,173,20
The 173 cases shown in this list represents the 2009/10 two-dose (pandemic and seasonal) influenza vaccination period. These are raw figures, no statistical manipulations have been applied. Does everyone reading this blog see NO UNUSUAL PATTERN in these figures? Are you convinced that the 173 case reports are merely due to reporting bias to the VAERS database? Would it be honest to prepare a journal paper stating only 2.1 miscarriages per million pregnant women vaccinated by analysing only the data consisting of mainly ones and zeros (and ignoring the large increase occuring in 2009/10 with the vaccine administered in any trimester)? Interested in your thoughts.

Gary S. Goldman,

Does everyone reading this blog see NO UNUSUAL PATTERN in these figures?

It’s impossible to say, since we don’t have enough information to say if what looks like an unusual pattern is unusual or not. I can think of two reasons that pattern might appear, neither related to vaccine safety. This could be one reason:

During the 2009-10 influenza season, excess morbidity and hospitalization admission due to the influenza A(H1N1) pdm09 (pH1N1) pandemic virus were observed among pregnant women. Therefore, they were listed as an initial target group to receive pH1N1 influenza vaccination when supplies were limited. Besides the monovalent pH1N1 influenza vaccination, the usual inactivated trivalent seasonal influenza vaccination was also recommended for pregnant women during the 2009-10 influenza season. A previous study reported that influenza vaccination coverage among pregnant women increased substantially during the 2009-10 influenza season in response to the pH1N1 pandemic.

A much higher uptake of the vaccine in that season would lead to a higher number of VAERS reports, as there would be more women having a flu vaccine in proximity to a miscarriage without any change in the incidence of miscarriage.

Another possible reason is that alternative health websites were buzzing with alarmist claims about the alleged dangers of H1N1 vaccine in the 2009/10 flu season. Many of them urged anyone who had suffered any possible side effects to make a VAERS report themselves. This webpage on Mercola’s website dated November 2009, has had 204,045 views, and includes a link to the VAERS website. It says:

Heartbreaking Stories of Losses After H1N1 Vaccination
The source links above contain personal stories of heartbreak – women who lost their babies just hours or days after getting the H1N1 vaccine this year. Naturally, the standard comeback is that miscarriages are commonplace, and surely have nothing to do with the vaccine. However, to simply dismiss these events as “coincidences” is a serious mistake. Perhaps some of the 20 women on one of the blogs would have miscarried anyway, but when a number of women have healthy, uneventful pregnancies up until they’re injected with a vaccine, and then suddenly miscarry, it most certainly warrants investigation!
Be Part of the Solution – REPORT All Side Effects to VAERS!
I’m willing to bet that most of these incidents have not been properly reported to the authorities, and this is something everyone needs to be better informed about. Please know that any time you take a pharmaceutical drug, or are injected with a vaccine of any kind, you need to report any and all side effects to your doctor and insist that he or she report it to the Vaccine Adverse Event Reporting System (VAERS). Ask to get a copy of the report to make sure it was done. Also know that YOU can report it yourself! You don’t have to go via your doctor. The VAERS web site allows you to fill out an adverse event report on your own.

It would only take 0.1% of the people who viewed that page to make a VAERS report relating flu vaccine to a miscarriage to account for your figures. That’s just one of many websites carrying the same message.

These kinds of possible confounders make VAERS a very unreliable source of the kind of data you have analyzed.

The 173 cases shown in this list represents the 2009/10 two-dose (pandemic and seasonal) influenza vaccination period. These are raw figures, no statistical manipulations have been applied. Does everyone reading this blog see NO UNUSUAL PATTERN in these figures?

Of course there is an unusual pattern. The problem is is that hacks like you use it to generate rubbish reports. How many of these reports did you verify? That would be none wouldn’t it? How could you not have considered the reporting biases that would have been generated due to the scares promulgated by unethical and incompetent “researchers” like yourself? Why didn’t you control for this? What could you have used for the denominator? You pulled this same crap with vaccines and infant mortality so you don’t honestly believe that you could be taken seriously do you?

You know, anyone can dumpster dive in VAERS. Mercola’s alarmist article about H1N1 vaccine causing miscarriages appeared in November 2009, has had more than 200,000 views online as I mentioned, and was also sent out to over a million subscribers by email. A search of VAERS for 2009/10, looking for spontaneous abortions and any flu vaccine generates 144 results. Here’s the breakdown by month and year reported:
Aug., 2009 0
Sep., 2009 0
Oct., 2009 4
Oct., 2009 4
Nov., 2009 43
Dec., 2009 32
Jan., 2010 11
Feb., 2010 6
Mar., 2010 11
Apr., 2010 5
May, 2010 2
Jun., 2010 2
Jul., 2010 2
Does anyone notice an unusual pattern in these numbers? I do, a strange peak of reports of miscarriage after flu vaccination at the same time Mercola urged over 1 million subscribers to report miscarriages after flu vaccinations. Almost 60% of the reports of miscarriage after flu vaccine were made within 3 months of Mercola’s article. I wondered what might have caused the smaller peak in March 2010 – could it have been this VacTruth press-release/article which appeared that month, “CoMeD Files Evidence of Miscarriage after Thimerosal-containing Flu Shots”, is coauthored by Paul G. King of the Coalition for Mercury-Free Drugs (CoMeD) Inc. and also mentions VAERS.

Paul G. King sounds very famililar – didn’t Gary S. Goldman coauthor a Medical Veritas article (PDF) with him? Could it be that one of Dr. Goldman’s associates is responsible for this peak in reports to VAERS in March 2010?

What I am wondering about and concerned about the H1N1 vaccine, is that there are no increases in reported miscarriages in years subsequent to the 2009-2010 influenza season.

Why aren’t you reporting the increase in reported miscarriages during the 2010-2011, 2011-2012 and now the 2012-2013 influenza season, Mr. Goldman?

Why isn’t the VAERS database flooded with reports of miscarriage, now that the H1N1 influenza strain has been incorporated into each seasonal flu vaccine for the past three years?

Gary S. Goldman is the guy whose *investigation* of the *super secret* Simpsonwood Conference report was used by the troll “vaccineshurtkids” to post walls of words Spam, on Emily Willingham’s Forbes blog.

I also provided a link to the Swedish study upthread that proves there was no uptick in miscarriages or adverse fetal outcomes for pregnant woman who received the H1N1 vaccine during 2009-2010…in fact the vaccine was shown to be offer protection to pregnant women and their fetuses:

http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2012.03470.x/abstract

Cripes, you are such an easy target Mr. Goldman.

@ Krebiozen:

“Paul G. King sounds very famililar – didn’t Gary S. Goldman coauthor a Medical Veritas article (PDF) with him? Could it be that one of Dr. Goldman’s associates is responsible for this peak in reports to VAERS in March 2010?”

Why yes, you are correct, Krebiozen. I quickie look at whale.to confirms the association. 🙂

http://www.whale.to/vaccine/king_h.html

(I *love* to use whale.to as a *source*)

@ lilady:

You are correct: whale.to is a source alright- actually more like the Mother-lode (or is it ‘load”?)

Does anyone notice an unusual pattern in these numbers?

Indeed Krebs; I would still like to know what Mr. Goldman used for a denominator for VAERS and the NCOW survey, how did he control for the extraordinary selection and reporting biases from VAERS and NCOW and did he account for multiple entries in both VAERS and NCOW. And did Jake Crosby generate the study design or will Mr. Goldman admit his blatant incompetence and dishonesty?

@ Krebiozen:

I always wondered by they mix lower case and caps in CoMeD … is it so it doesn’t resemble to word ‘comedy’?

OT- although I don’t have the foxes at my entrance way YET..
I understand that they hang out in a local park ( 1.5 miles from here).. the ex wants to buy them cat food.

@Gary S Goldman

These are raw figures, no statistical manipulations have been applied. Does everyone reading this blog see NO UNUSUAL PATTERN in these figures?

Are you seriously using a correlation/causation fallacy here?

didn’t Gary S. Goldman coauthor a Medical Veritas article (PDF) with him?

Ah. So one of Goldman’s past colleagues was one of the people explicitly soliciting an influx of reports to VAERS, which Goldman is reporting as if it were a spontaneous event.

The circle of life!

And your other “business”, Mr. Goldman…the founder and proprietor of the “Pear Blossom School”…a long-distance diploma mill that awards “diplomas” for kids who are home-schooled. I see that you are the recipient of a special award:

http://www.pearblossomschool.com/IEY.html

I see where you were designated “International Educator of the year 2008”, by the prestigious “International Briographical Centre of Cambridge England”. What were you qualifications for that prestigious award?

http://www.internationalbiographicalcentre.com/pricing_guide.php

Like shooting fish in barrel…blindfolded.

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