miscarriage

Does the flu vaccine cause miscarriages?

oracknows — Thu, 14 Sep 2017 06:50:50 +0000

Does the flu vaccine cause miscarriages?

The reason there wasn't a post yesterday is simple. The night before, I was feeling a bit under the weather. As a result, I went to bed early, neglecting my blogly responsibilities. As I result, I missed the release of a whopper of a study that normally would have been all over like...well...choose your metaphor. On the other hand, the one day delay isn't necessarily all bad because it lets me see the reaction of cranks to this study, the better to apply some not-so-Respectful Insolence to it. The crankiest of these cranks, of course, is Mike Adams, a grifter deep in the thrall of any form of pseudoscience that he can sell to burnish his brand and keep the rubes buying and who knows how to whip his minions into a fine frothy head of anti-pharma conspiracy mongering. In actuality, though, I was a little bit disappointed, as Adams was almost restrained, at least by his usual crazed standards:

A CDC-funded medical study being published by the medical journal Vaccine has confirmed a shocking link between flu shots and spontaneous abortions in pregnant women. The study was rejected by two previous medical journals before Vaccine agreed to publish it, further underscoring the tendency for medical journals to censor any science that doesn’t agree with their pro-vaccine narratives.
“A study published today in Vaccine suggests a strong association between receiving repeated doses of the seasonal influenza vaccine and miscarriage,” writes CIDRAP, the Center for Infectious Disease Research and Policy.

“A puzzling study of U.S. pregnancies found that women who had miscarriages between 2010 and 2012 were more likely to have had back-to-back annual flu shots that included protection against swine flu,” reports Medical Xpress, a pro-vaccine news site that promotes vaccine industry interests. Notice that the opening paragraph of their study assumed the study couldn’t possibly be true. It’s “puzzling” that mercury in flu shots could cause spontaneous abortions, you see, because these people have no understanding of biochemistry and the laws of cause and effect.

Actually, as has been documented so many times before, it is Mike Adams who has no understanding of biochemistry—or any other science—other than what it takes for him to portray himself to his gullible followers as a "real scientist." As for the "laws of cause and effect," whenever someone says something like that in reference to an epidemiological study, I know he's really, really clueless, because if there's anything that's very difficult to do in an epidemiological study with reliability it's determining cause-and-effect. That's why the cardinal rule of epidemiology is that correlation does not equal causation. It might, but usually it doesn't, and it usually takes a whole lot more than just one study with a correlation to start to suggest causation. This is particularly true when a study like the one Adams is gloating about is such an outlier, which this study most definitely is, as you will see. It's also an exercise in data dredging that illustrates the danger of small numbers in studies like this.

Let's go to the study itself. I can't help but note that Frank DeStefano of the CDC is a co-author. DeStefano, as you might recall, is one of those CDC investigators that antivax conspiracy theorists like those who made the propaganda film VAXXED portray as one of the main villains in the "CDC whistleblower" conspiracy theory. Also, several of the authors receive pharma money for research support. Nicola Klein, for instance, receives research support from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, MedImmune, Novartis, and Protein Science, while Allison Naleway receives funding from GlaxoSmithKline, MedImmune, and Pfizer. Others receive support from MedImmune and Novavax. So basically, this was a study funded by the CDC and carried out by CDC scientists and scientists receiving significant pharma funding. I just couldn't resist pointing that out. I know, I know, antivaxers will claim that the findings were so compelling that not even the CDC and pharma shills could hide them, but it would amuse me to point these things out to antivaxers.

Yet, here we see Del Bigtree, producer of VAXXED, gleefully citing J.B. Handley gloating over this study:

Tough breaking news for @ChelseaClinton @DrPanMD @doritmi FLU SHOT linked to MISCARRIAGE! #endvaxinjury https://t.co/6JwjnsAviY

— Del Bigtree (@delbigtree) September 13, 2017

I wonder if he knows that DeStefano is a co-author. He probably doesn't care, because DeStefano, like any scientist, can be a hero or a villain depending solely upon whether he produces information or studies that agrees with the antivaccine narrative that the flu vaccine is not just useless but dangerous. Be that as it may, the article above is a typical bit of Handley's Dunning-Krugger arrogance of ignorance, even more full of hyperbole and nonsense than the usual Mike Adams' endeavors in that area. Indeed, Handley even uses the argumentum ad package insert gambit. (Whenever I see that gambit used by an antivaxer, my estimation of his cluelessness goes up several notches, which for Handley is really saying something.) In any case, you can get a feel for how much the authors of this study are stretching to find a correlation—any correlation—between influenza vaccines and miscarriages that they're looking at combinations of vaccines by their brief justification for the study:

Since 2004, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and other organizations have recommended routine influenza vaccination for pregnant women regardless of gestational age [1,2]. Influenza in pregnancy can cause serious, life-threatening illness in both the mother and fetus, as demonstrated during the 2009 pandemic [3,4]. Numerous studies of influenza vaccine during pregnancy have not identified serious safety concerns [5–12], but relatively few investigations have evaluated vaccination in the first trimester, a period when the embryo is highly vulnerable to teratogens and other factors [5,13]. A case-control study conducted by the Vaccine Safety Datalink (VSD) demonstrated that influenza vaccination during early pregnancy in the 2005–06 and 2006–07 influenza seasons was not associated with spontaneous abortion (SAB) [14].

The emergence of a pandemic influenza virus, A/California/ 7/2009 (H1N1)pdm09 (pH1N1), led to rapid development and widespread use of vaccines containing pH1N1 antigens. Several studies have evaluated the safety of vaccines containing pH1N1 in pregnancy, but few have focused on outcomes in early pregnancy [15–19]. Using a design and protocol similar to the previous study [14], we conducted a case-control study to determine if receipt of influenza vaccine containing pH1N1 was associated with SAB.

Notice the eight studies cited (references 5-12) that failed to find significant safety issues with the vaccine in pregnancy, and a study (reference 14) using VSD data failed to find an association between flu vaccination with spontaneous abortion. That's actually a lot of data for the safety of the flu vaccine during pregnancy, which makes me wonder what the justification for yet another study looking for an association between influenza vaccination and miscarriages. If I were a funding agency and received a grant application to do a study like this with text above in the "Background and Significance" or the "Impact" section, my first reaction would be: Why on earth would we fund this? It's all been done before, many, many times. Yet the CDC funded this study. So much for antivax claims about the CDC not being concerned about vaccine safety and not being willing to look for adverse reactions due to vaccines.

I also find it rather odd that the authors would say that few studies have been done looking for a correlation between vaccination against influenza, when in fact there have been a lot, many well-designed, and they've pretty much all been negative. Whenever you see a study that finds something a lot different from the bulk of the studies that have been done before, the first question to be asked is: Are the results of the current study so robust that they indicate a hole in the existing data addressing the question asked that we should begin to question the cumulative results of all the studies that have gone before? Keep that question in mind as I continue.

Also consider the bias that exists in journals to publish novel findings. As this news report points out, this is the "first study to identify a potential link between miscarriage and the flu vaccine." That's almost certainly the reason that it was published. Adams, in his haste to portray as a conspiracy to silence, inadvertently tells me something. That this paper was rejected by two previous journals is not surprising to me. What is surprising is that Vaccine ultimately accepted it. Of course, how Adams would know that this paper was submitted elsewhere and rejected, I don't know, which is why I have my doubts about Adams' claims.

So what about the study itself? First, it's a case-control study. Basically, that means that the authors found a cohort of women who had miscarriages (the cases) and compared them to a cohort of women who didn't have miscarriages but instead delivered full term infants or had stillbirths during the study period (the controls). The authors chose two flu seasons (2010 to 2012) and asked if women who had miscarriages were more likely to have been vaccinated for influenza within 28 days prior to miscarriage, as well as for different time periods before miscarriage.

The most critical aspect of any case control study if, of course, the matching of cases to controls. The idea is to match them as closely as possible on all relevant factors other than the condition under investigation (in this case, miscarriage). Not uncommonly, investigators will do a 2:1 match, controls to cases, in order to make the comparison more robust. It's not mandatory, and Donohue et al chose not to do this. In this study, cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. I also note that the database they used was the Vaccine Safety Datalink (VSD). As I like to say, the VSD is an excellent rebuke to antivaxers who claim that doctors don't care about vaccine safety. It's a database designed to document adverse events associated with vaccination, and it's a huge database. I've discussed it before on more than one occasion.

So what did the study find? Here's a summary of the cases analyzed:

if you look at the tables in the paper, the first thing you will notice is that the adjusted odds ratios (aORs) for miscarriage as a function of having received the flu vaccine are nearly all around 1.0 or not statistically different from 1.0. Obviously, there are exceptions. Basically, the study found that, if a woman had consecutively received a flu vaccine containing the 2009 H1N1 virus the season before and had the flu vaccine in one of the two seasons studied, the aOR in the 1–28 days was 7.7 (95% CI 2.2–27.3). Otherwise, the aOR was 1.3 (95% CI 0.7–2.7) among women not vaccinated in the previous season; i.e., not statistically significant from 1.0, meaning no detectable difference in miscarriage rates compared to women who had not been vaccinated. This effect was noted in both seasons.

Now here's where you should be skeptical.

This study has several important limitations. First, the most striking findings relate to the association between SAB and IIV [inactivated influenza vaccine] in women who previously received pH1N1-containing vaccine. This interaction effect was not an a priori hypothesis; the results were generated in a post hoc analysis with small numbers of women in the various subgroups. Although the interaction was observed in each of the two seasons studied, the point estimates were substantially larger (though not statistically different) in the first season for reasons that are unclear. Second, although most cases had an ultrasound, assignment of a precise date of SAB was challenging. With guidance from an obstetrician we integrated different types of information from the medical record (e.g., ultrasound results, clinical and laboratory findings, provider notes) to estimate the timing of the SAB. Estimation of SAB dates was independent of vaccination status so any error should bias the results toward the null (i.e., non-differential misclassification). Third, we studied only women who had clinically confirmed SAB; the proportion of women with clinically unrecognized pregnancy loss is uncertain but may be substantial [50,51]. Our results could be biased if women who sought care for SAB were more likely to be vaccinated in the 28-day exposure window.

So what we're looking at is an association, nothing more. It's an association with a lot of caveats, too. Basically, having found nothing more than one association with an aOR of 2.0 for the 1-28 day window of exposure to the influenza vaccine before miscarriage that was barely statistically significant (95% confidence interval: 1.1-3.6), the authors did a post hoc analysis looking for other associations. (Never mind that the "association" they found was eminently unimpressive given the size of the confidence intervals.) "Post hoc" means that they did additional analyses not originally specified. Basically investigators don't usually do post hoc analyses if there is a robust association in their data. They do it when they fail to find an association or only find an unimpressive association that is not robust. Also, post hoc analyses are prone to type 1 errors, which means finding a statistically significant "association" where there is none; i.e., finding a false positive. When the numbers in the subgroup are so small and the study is observational (i.e., retrospective), that tendency is even stronger. Then there was the issue that the cases and controls were not as comparable as one would like in a case control study. For example, cases were significantly older than controls and more likely to be African-American, to have a history of 2 spontaneous abortions, and to have smoked during pregnancy. The authors did some correcting for age and history of spontaneous abortions, but it's questionable to me whether it was adequate.

Basically, the authors did what we refer to as a subgroup analysis, in this case the subgroup being women who had received H1N1 vaccination the season before they received the flu vaccination in the seasons examined? That clearly wasn't a primary hypothesis being tested. Rather, it was a hypothesis the authors clearly came up with while doing the study. One wonders if this analysis was prespecified or whether the protocol was changed midway through. I only ask that because antivaxers went wild over claims by the "CDC whistleblower" that the Atlanta MMR study changed its protocol part way through the study, but, here, where the analysis seems to suggest such an "adjustment" during the study (although it is certainly possible that the H1N1 analysis was prespecified in the original protocol, given the choice of the 2010-11 and 2011-12 flu seasons), we hear...silence. Whatever the case, there clearly was post hoc analysis strongly resembling p-hacking going on here, in which the investigators, having failed to find much, started looking at other potential associations. Certainly, it smells that way.

Speculations about the protocol aside, the investigators found what they found, namely an aOR of 7.7 for cases versus controls for exposure to the H1N1 vaccine the year before plus the flu vaccine within 1-28 days before their miscarriages. This was based on some very small numbers, though, namely 14 miscarriages and 4 controls. In other words, this is almost certainly a statistical fluke, given that it was only found for women who had received H1N1 the season before and had received the flu vaccine within 28 days of their miscarriage, and that the association was not observed for pretty much any other time window or combination. When considering such a result, one also has to consider biological mechanism and plausibility, and it is just not very plausible from a biological or immunological standpoint that this combination of flu vaccines—and only this combination—given only during a specific time window will cause miscarriages. Like Dr. Gregory Poland, the editor of Vaccine, I don't believe these findings, either.

I particularly don't believe them in light of what we already know, based on studies Tara Haelle summarized the data with respect to flu vaccines and miscarriages, stillbirths, and birth defects in 2014, using mainly studies published during the prior two years, and the results were very consistent and overwhelming: There was no association between vaccination for influenza and adverse fetal outcomes. Just for yucks, I did some PubMed searches myself for more recent studies, and found basically the same thing, but instead of listing those studies, I'll just refer you to a recent large meta-analysis that found that the risk of stillbirth was actually lower in women vaccinated against influenza and no difference in the risk of spontaneous abortion. In other words, this new study is an outlier. It's such an outlier, that scientists are correct to be very skeptical of its results. Heck, even the authors are skeptical of its results. Unfortunately, they're not so skeptical that they don't resist making the call for "more research." They'll probably get the funding for that "more research," and then when the inevitable negative study is finally published, no one will remember it. They'll all remember this study, and, of course, the antivaccine movement will be flogging it for years to come.

oracknows Thu, 09/14/2017 - 02:50

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

oracknows — Wed, 28 Nov 2012 02:00:00 +0000

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.

oracknows Tue, 11/27/2012 - 21:00

Tags

Antivaccine nonsense

complementary and alternative medicine

complementary and alternative medicine

medicine

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.

From the OP:

Such is the power of Orac.

Against which there can be no victory.

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.

My flu shot turned me into a newt.

I got better.

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-…

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/abs…

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.

Thanks, Todd.

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/abs…

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.

You would think NCOW would understand the value of herd immunity.

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. :-)

@ Autismum: Know the feeling. I once was a baby pygmy marmoset!

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?

DAMMIT NARAD.

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?

Denice Walter

‘Wow, you changed species!’

Tell AutismMom that. I at least stayed a mammal, albeit one with some very unusual sex-related genetics. (Aren’t I a tease :-) ) AutismMom changes into an entirely differ class of life :-)

Does anyone want to answer my simple question:
Why vaccinations are mandatory (or in fact the impression is being created that they are required)?
It's a very simple question in the field of freedom of choice, right?
http://www.naturalherbalweight.com/

@Adam

Are you really asking, or are you just attempting to commit spam?

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."

Scott above is copy-pasting his own comments from elsewhere .

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?

That is: not sitting around. . . no "the"

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/abs…

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"?)

@ Denice Walter:

"Mother Lode" or "Mother Load" either/or.

Here for Mr. Goldman, an excellent site for your "activities".

http://dumpsterdiversparadise.com/FAQ.html

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.

ScienceMom,

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.

Indeed. Of course I am by no means claiming that the patterns in the VAERS data are due to Mercola et al.'s exortations, but I think the temporal association is interesting and just as convincing, if not more so, than Goldman's claims.

Denice,
A while ago I horrified a rural-dwelling colleague who keeps chickens when I mentioned we feed foxes. I don't think he was convinced by my claims that rural and urban foxes are entirely different species ;-)

the ex wants to buy them cat food.

We get a bag of chicken offcuts from our local butcher once a week; cheap, nutritious and it's nice to see how healthy they look compared to how mangy they used to be. I get to have a closer look once or twice a year when one of them gets hit by a car and goes off to die in someone's back yard. I'm the go-to-guy for vulpine corpse disposal in my street, since city dwellers are so squeamish about dead critters - my country upbringing has its uses.

lilady,
I lived and worked in Cambridge England for the best part of a decade, but I never heard of 'The International Biographical Centre'. I wonder why.

@ Krebiozen:

"lilady
I lived and worked in Cambridge England for the best part of a decade, but I never heard of ‘The International Biographical Centre’. I wonder why."

Hmmmm, maybe you didn't need to pad your C.V., Krebiozen?

(Like shooting fish in a barrel.... with the lights off...and blindfolded)

Krebiozen,

"I lived and worked in Cambridge England"

Spent a little time there myself.

Wow, why didn't I become a computer scientist?? A field of study where you don't have to work hard doing things like eliminating confounding variables from your data, you just take raw data, say "I think I see a Pattern!" and go straight into deciding what it Means?? I feel silly now for going into a field where you actually have to do things right!

No, Antaeus, computer scientists aren't supposed to make stuff up either. However, computer science isn't quite like biology -- it's more like mathematics.

Please read the manuscript to learn the limitations of the study and to see what denominators were used. Some comments above are adversarial and flawed. For example, one blogger claims heightened reporting bias in VAERS, starting in November with 43 reports, due to Mercola's report. Interestingly, Mercola's report went online November 28. So how many of the peak 43 reports in November are attributed to this reporting bias? Also, there were fewer reports in December. If you still have questions after reading the paper, please contact me directly at my e-mail address
gsgoldman@roadrunner.com, and I will be pleased to address any concerns and criticisms. I have a track record of successfully meeting challenges where individuals told me, "Goldman, this simply cannot be done--you are incorrect." (No offense of course to Orac who is always right!)

Mr. Goldman, I see you are avoiding answering to the problems with your data mining. Both VAERS and internet survey results are self-selected data, which is highly biased. You are continuing to confirm that you have never taken a beginning undergraduate statistics class, and that you had decided on the results before you went data dumpster diving.

Yes, I have previously received criticisms such as expressed by Chris. In fact, after receiving a similar criticism (on another epidemiological study I had performed) from Dr. Jane F. Seward (currently CDC's deputy director for the division of viral diseases), I was assigned to work with an expert epidemiologist at CDC. He concluded, "“[Y]our [Goldman's] work… while not mainstream epidemiology (not a criticism: why should it be?), is rather extraordinary. I believe that we can do some truly great work together, and communicate it to the folks who need to learn about it.” We went on to do a collaborative project. I have reviewed several hundrded papers dealing with analysis of VAERS data. And generally speaking, there are indeed challenges working with such data. However, in some specific instances, especially more serious adverse outcomes, you will find that VAERS reports do indeed correlate with rates found in the general population. I would encourage you to review all 200+ papers using VAERS in Pubmed--a majority by CDC authors and note the varying methodologies utilized and the quantitative results derived. Do you really consider all 200+ papers that use VAERS data to be dumpster diving? Also, it would be good to review papers dealing with capture-recapture, although the statistical analysis of the data is not necessary to demonstrate the conclusions reported. (P.S. I have taught statisics at Calif. State University at Fullerton)

I would encourage you to review all 200+ papers using VAERS in Pubmed–a majority by CDC authors and note the varying methodologies utilized and the quantitative results derived.

Howsabout you start by providing the precise search terms?

OK, 'vaers[All Fields] OR "vaccine adverse event reporting system"[All Fields]' gets up to 214. Let's first assess whether "a majority [are] by CDC authors. One gets 50 results from the previous query plus '(cdc[ad] OR centers for disease control[ad])'. Already, I'm less than optimistic in this diversionary maneuver.

However, in some specific instances, especially more serious adverse outcomes, you will find that VAERS reports do indeed correlate with rates found in the general population.

Do you have data to support this claim? I couldn't find any such evidence reported or cited in your manuscript.

the statistical analysis of the data is not necessary to demonstrate the conclusions reported.

Could you clarify what you mean by this? Are you referring to your own manuscript here? If so, on what basis are you deciding that statistical analysis is nor necessary?

For example, one blogger claims heightened reporting bias in VAERS, starting in November with 43 reports, due to Mercola’s report. Interestingly, Mercola’s report went online November 28. So how many of the peak 43 reports in November are attributed to this reporting bias?

Mercola's articles are sent out to people on his mailing list *before* they go online.
If you accept that VAERS data could have been corrupted by Mercola's exhortations to his audience to flood the system with mala fide complaints, it is not particularly convincing to argue that "Oh, the corruption of the data only started *here*".

Gary S. Goldman,

Some comments above are adversarial and flawed. For example, one blogger claims heightened reporting bias in VAERS, starting in November with 43 reports, due to Mercola’s report.

You presented the raw data, and asked:

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.

I answered your questions, suggesting some possible causes for the "unusual pattern" you noted. In November 2009 over 1 million people were told that flu vaccine causes miscarriage, encouraged to report any such events to VAERS and provided with a direct link to the VAERS website to do so. Are you seriously claiming that it is impossible that this had an effect on reporting? How is this either adversarial or flawed?

Interestingly, Mercola’s report went online November 28. So how many of the peak 43 reports in November are attributed to this reporting bias?

You tell me. You're the one making the claims that these reports are due to damaging effects of flu vaccine and not to reporting bias. Mercola's report went on-line on 11/28, but when did he send out the email? Do you know? How many of the more than 1 million people this was sent to made a report to VAERS the very same day, or the next day or the day after that? What about the other antivaccine propaganda that was being circulated at the time, that Orac mentions above?

Also, there were fewer reports in December.

Which is consistent with my hypothesis that an unknown number of people read the article and made a report over the following few weeks. Here's the breakdown again:
Aug., 2009 0
Sep., 2009 0
Oct., 2009 4
Nov., 2009 43
Dec., 2009 32
Jan., 2010 11
Feb., 2010 6
Don't you find it interesting that there were only 4 reports in October, then suddenly 43 in November? You have to eliminate reporting bias before leaping to the conclusion that these were adverse events caused by the vaccine.

Then there is this paper: Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies

It is reasonable to expect a newsletter from some online quack who sells supplements to affect VAERS reports.

That seems a sensible paper, Chris. The authors note that "when VAERS may be manipulated inappropriately to influence litigation and public policy, it is important to understand this distortion."

What are they up to these days?

Digging into the VAERS data from November 2009 I find that there were an average of 38 reports made to VAERS each day from 11/26/2009 to 11/29/209 and 245 reports made on 11/30/2009. I haven't looked at how many of these were flu vaccine or indeed spontaneous abortion, but I think the large variation is interesting in itself.

There's a new Forbes blog up about the DSM 5 ASD diagnostic criteria. I've been *engaging* "green-and-healthy" who posted about Goldman's study...(expand all comments):

http://www.forbes.com/sites/timworstall/2012/12/03/look-out-for-an-incr…

I've also invited "greenie" to come and post on RI...should be good for a load of laughs.

Mercola’s report went on-line on 11/28, but when did he send out the email?

Lew Rockwell carried a VAERS exhortation from Mercola on October 22, 2009.

(Which Mercola also carried on October 20.)

HDB:

What are they up to these days?

Who is "they"?

I do remember that in the time period that the paper I cited covers there were lawyers who were actively promoting "vaccines=autism" lawsuits. One of them was Andrew Waters of Waters and Kraus in Texas. At one point they had registered the website "autismfraud."

It used to be easier to find articles on Mr. Waters, but it has been almost a decade and most of them are old. It does include one from saved by John Scudamore of whale.to:

Attorney Andy Walters says that the unreleased CDC report, obtained by the SAFEMINDS advocacy group, found a 2.48 times increased risk of autism in children exposed to more then 62.5 micrograms of mercury before they were 3 months of age. In a press release, Walters and Kraus notes that "in the United States, courts of law have generally held that a relative increased risk of 2.0 or higher is sufficient to substantiate that a given exposure causes disease." Walters says that in many of the cases that his firm has evaluated, autistic children have received more than 62.5 micrograms of mercury through pediatric vaccines.

What are they up to these days?
Who is “they”?

The eminently sensible authors of "Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies",

Oh. From the Googles....

http://www.pharmacy.utah.edu/pharmacotherapy/faculty/goodman.htm

http://www.healthpartners.com/locator/practitioner/detail.do?personnelI…

To clarify, those sensible authors include a pediatrician and a researcher in something I have never heard of:

Dr. Goodman is an Assistant Professor in the Department of Pharmacotherapy at the University of Utah College of Pharmacy. He received his doctorate from the University of Texas and Masters degree from the University of Oregon. Prior to joining the University of Utah, he spent time as a consultant with Xcenda and as a research investigator at HealthPartners and Kaiser Permanente. Dr. Goodman is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology. His research interests include vaccine safety, drug safety, the etiology of childhood neurodevelopmental disordors, patient-reported outcomes in childhood disease, and the statistical analysis of rare events.

In short, two medical care professionals who care about children and science.

Looking at this from a different angle, if the flu vaccine in the 2009/10 season caused miscarriages, we would expect to see an increase in reports of fetal deaths in states with a high uptake of the vaccine. The highest uptake was in Vermont (with 63.3% of pregnant women receiving seasonal flu vaccine, and 49.9% receiving both seasonal and H1N1 vaccines). Vermont had no increase in reported fetal deaths in 2009, in fact there was a fall in the fetal death rate. Though the figures for 2010 are not yet available this does not support Gary S. Goldman's hypothesis.

There is more Krebs; I'm looking at his "study" right now. It's truly a howler.

<blockquote.Please read the manuscript to learn the limitations of the study and to see what denominators were used.
I am and you, not only ignored the limitations of the data sources you used but actually introduced more biases and tried to make your rubbish look legitimate with a lot of statistical voodoo. Interesting that you referenced Moro et al. who examined VAERS data for a signal and couldn't find any. Moro et al. ( http://www.ncbi.nlm.nih.gov/pubmed/21861964 ) actually corrected for double entries and ascertained medical records for the majority of AE reports. You did not.

You on the other hand used VAERS and NCOW, didn't correct for multiple reporting to VAERS nor accounted for NCOW respondents who also made a VAERS report, waved your magic wand and decided that the actual number of VAERS reports should be "an estimated ascertainment-corrected 1321 (95% CI: 815–2795) fetal-loss reports."

And this is what you used to "control for" the Weber Effect:

"Quantitative estimate of increased AE reporting attributed to a Weber-like effect

The factor of increased reporting that might be potentially due to a Weber-like effect in the 2009/2010 influenza season is quantified by computing the ratio of 7734 females reporting AEs associated with A-H1N1 vaccine to the 4863 females reporting AEs associated with seasonal TIV (Table 5), yielding a 1.6-fold increase in the A-H1N1 AE reports. Based on this potential Weber-like effect, given 22 reports of fetal loss associated with TIV, we would have expected approximately 35 fetal-loss reports (actually 1.6 × 22 TIV = 35.2 reports) attributable to a ‘Weber-like’ effect associated with the A-H1N1 vaccines. Thus, the magnitude of the observed possible Weber-like effect explains neither the 170 fetal-loss reports in VAERS nor the nearly eightfold increase (170 A-H1N1 fetal-loss reports/22 TIV fetal-loss reports) that was found."

That's right folks, Goldman used the number of women reporting to VAERS in years before and after 2009/2010 as the denominator to control for reporting bias. Not the fact that pregnant women were given specific VAERS cards at the time of their vaccination, not the fact that VAERS receives an increase of AEs during periods of heightened awareness surrounding a new vaccine and certainly not the hysterical reports of Mercola et al. prior to the large increase of VAERS reports in November.

Some comments above are adversarial and flawed. For example, one blogger claims heightened reporting bias in VAERS, starting in November with 43 reports, due to Mercola’s report. Interestingly, Mercola’s report went online November 28. So how many of the peak 43 reports in November are attributed to this reporting bias?

It's a perfectly legitmate point that Mercola et al. probably influenced VAERS reports and you have your dates wrong as evidenced by others. Did you bother to notate when vaccines were received and reporting dates? Did you bother to even mention this as a potential reporting bias in your "study"?

Also, there were fewer reports in December. If you still have questions after reading the paper, please contact me directly at my e-mail address
gsgoldman@roadrunner.com, and I will be pleased to address any concerns and criticisms. I have a track record of successfully meeting challenges where individuals told me, “Goldman, this simply cannot be done–you are incorrect.” (No offense of course to Orac who is always right!)

Of course December is lower, the vast majority of the target populations were already vaccinated and those that were whipped up into a frenzy had already reported. Another indicator of reporting bias that you failed to control for but rather use it to support your failed hypothesis that H1N1 vaccination causes foetal demise. You can answer criticisms right here since the discussion is specifically about your latest VAERS dumpster-diving session. You're an arrogant pillock to boot and don't know better when you are being told you are incorrect. If you think your latest drek is "successfully meeting a challenge" then you are delusional as well.

In fact, after receiving a similar criticism (on another epidemiological study I had performed) from Dr. Jane F. Seward (currently CDC’s deputy director for the division of viral diseases), I was assigned to work with an expert epidemiologist at CDC. He concluded, ““[Y]our [Goldman's] work… while not mainstream epidemiology (not a criticism: why should it be?), is rather extraordinary. I believe that we can do some truly great work together, and communicate it to the folks who need to learn about it.” We went on to do a collaborative project.

Oh how convenient, some unnamed epi at the CDC thinks you're nifty. You aren't impressing anyone here.

I have reviewed several hundrded papers dealing with analysis of VAERS data. And generally speaking, there are indeed challenges working with such data. However, in some specific instances, especially more serious adverse outcomes, you will find that VAERS reports do indeed correlate with rates found in the general population. I would encourage you to review all 200+ papers using VAERS in Pubmed–a majority by CDC authors and note the varying methodologies utilized and the quantitative results derived. Do you really consider all 200+ papers that use VAERS data to be dumpster diving? Also, it would be good to review papers dealing with capture-recapture, although the statistical analysis of the data is not necessary to demonstrate the conclusions reported. (P.S. I have taught statisics at Calif. State University at Fullerton)

Don't put yourself in the same class as legitimate investigators Goldman. If anyone wants to see how the real scientists go about conducting a study using VAERS data and compare that to the rubbish you produce then I suggest following the Moro et al. link who found orders of magnitude lower spontaneous abortions and stillbirths in vaccinated women than in the entire cohort. So when you do it, yea it's dumpster-diving.

On Dec 1, 2012 above Adam posted the question of it simply being a question of choice:

Several here posted responses of opinion, there is recent case law that has drawn this question into focus:

http://www.courthousenews.com/2012/12/03/vaccine.pdf
Upset mother sues for inoculating her child without her consent.

This ruling was troubling for me. April 26, 2009 Sebelius declares http://www.gpo.gov/fdsys/pkg/FR-2010-03-05/html/2010-4644.htm Rather than find that there is a Swine flu outbreak she seems to be defining the need to develop this drug through human testing as a countermeasure to prevent a pandemic all with out ever citing and evidence of a epidemic much less a pandemic that places the national security at risk. Further she cites the limitation of damages for those harmed by her testing directing them to http://www.hrsa.gov/countermeasurescomp/default.htm <---- So I clicked the link to the countermeasures comp and I find The PREP Act also confers broad liability protections as defined in section 319F-3(i)(2)of the PHS Act. Liability protections cover the manufacture, testing, development, distribution, or use of the designated covered countermeasure.

So I am wondering, where is the Pandemic that she is conducting human trials on? Did it exist or are we experiencing a false emergency to collect data responses to testing? Why do I ask? The President's 2012 budget cites this major accomplishment http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61304… citing a grand total of 34 probable cases of flu. Probable? Only 11 women were hospitalized across 13 states. A statistic that hardly seems to be a pandemic or epidemic, considering the fact they were pregnant.

Am I missing something here? That budget indicates we spent some 675 million dollars towards this single public health emergency where 11 women possibly had the flu and were hospitalized during their pregnancy. Women do get hospitalized during a pregnancy however that doesn't always establish a public health emergency unless you live in Berlin or Chicago during the 1940's and happened to be considered an "undesirable" while they were testing the known efficacy of Diethylstilbestrol, (After it had been previously tested in Europe). It turns out the drug oddly was associated with a high number of miscarriages. The women who it was tested on were not advised so they could not have consented to it's use. Much like the underage child of the mother who filed suit in this case those women in Chicago and London weren't told taking DES would cause miscarriages during the 1940's before it was approved by the FDA. DES was approved for use despite it's adverse effects to women and was left on the market until 1975. Surprise this drug causing babies to miscarry also had the benefit of causing cancer.

The Flu is a fairly normal event. Where is the public emergency? Assuming arguendo, that a certain number of the population would miss work as described in the passionate response of one of the posters here the presidential budget calculated that realized contingency for savings to have been 200million. Yet we spent at a minimum 675 million? Why would we do that? Could it be because there is well over 6 billion in the budget alotted for data mining? Where is the savings? I don't get it.

Bo:

The President's 2012 budget cites this major accomplishment http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61304… citing a grand total of 34 probable cases of flu. Probable? Only 11 women were hospitalized across 13 states.

Read that link again, it was 34 women in one month: "April 15 to May 18, 2009." That paper was a preliminary study trying to predict who was susceptible in order to have a strategy. It was a new flu strain, and lots of work needed to be done due to past history (1918, 1957, 1968).

So, yes you are missing something: most of the data. Try this report: Maternal and Infant Outcomes Among Severely Ill Pregnant and Postpartum Women with 2009 Pandemic Influenza A (H1N1) --- United States, April 2009--August 2010. It says:

From April 15, 2009, to August 10, 2010, a total of 347 severely ill pregnant women, including 272 who were admitted to the ICU and survived and 75 pregnant women who died from 2009 H1N1, were reported to the surveillance systems. Fifteen severely ill postpartum women, including nine who died, also were reported.

Also do not forget the 282 children who died from H1N1.

Bo:

The President's 2012 budget cites this major accomplishment ... snip Lancet abstract...citing a grand total of 34 probable cases of flu. Probable? Only 11 women were hospitalized across 13 states.

So, yes you are missing something: most of the data. Either you did not look very hard, or are deliberately cherry picking. Try this report: Maternal and Infant Outcomes Among Severely Ill Pregnant and Postpartum Women with 2009 Pandemic Influenza A (H1N1) --- United States, April 2009--August 2010. It says:

From April 15, 2009, to August 10, 2010, a total of 347 severely ill pregnant women, including 272 who were admitted to the ICU and survived and 75 pregnant women who died from 2009 H1N1, were reported to the surveillance systems. Fifteen severely ill postpartum women, including nine who died, also were reported.

Also do not forget the 282 children who died from H1N1.

Am I missing something here?

Yah, you seem to be blending 42 USC §§ 247d-6a and -6d in arriving at the "human testing" bit, or something. It's difficult to interpret the latter (PREPA), which was added in 2005, without reading the preceding subsections. In any event, your complaint should be with the law itself, rather than manifesting as "Sebelius this, Sebelius that." I'm not going to bother looking at the party lines on support for addition of this item. Neither am I enamored of legislation such as this being tacked onto a bill at the last minute and not being debated in the least.

(PDF warning on that link, sorry.)

The Flu is a fairly normal event. Where is the public emergency?

You're also badly decontextualizing this through hindsight, BTW, which is a classic cheap shot at public health.

[sarcasm]
Oh, come on, Narad! Surely a few dead pregnant women and kids are nothing to worry about.
[/sarcasm]

I was taken by Bo's use of one month of data, plus the minimizing of the demographics and numbers of deaths. Like there needs to be a minimum number of casualties needed in order to worry about preventing the illness. Like the folks who say measles was not that bad a deal when it "only" killed four to five hundred people a year.

I was taken by Bo’s use of one month of data, plus the minimizing of the demographics and numbers of deaths.

There appear to have been some typically frenzied headlines in places such as "Health Impact News." My favorite so far, though, is perennial bumbler Patricia Finn's take on it at Facebook: "This is some interesting new law here in New York...". Um, no, Patricia. Stick to your deranged suit against the Grievance Committee for the Ninth Judicial District.

(In addition, HIN brilliantly repeats the error from Courthouse News Service that the "vaccine" in question was Peramivir. The latter at least has some sort of excuse in that the NY appeals court commits this error in passing before getting to the fact that it was, of course, H1N1.)

@Narad

I didn't take one month of data as an agenda. I used the information the president provided. I referenced where I got it in my post. I'm happy to look at other unbiased information but here is the link to the budget:
http://www.cdc.gov/fmo/topic/budget%20information/appropriations_budget… see pgs 133-4. After looking at page 48 as well the total spent from 2009-12 and you will find I didn't even total all of it just 2 years so my number were slanted in favor of the government not against it.
The reason HIN reports it was Permavir is because that is what is in the case law in the pdf

I agree with you the alarm may be the way this law is structured as it provides conflict of interest to go unchecked.

"cheap shot" ? 2 million women were exposed to Diethylstilbestrol when big pharma knew full well they were providing medicine that would cause miscarriage.

Accusing me of hindsight is ripe, I placed my post here hoping to find the data to support a seasons flu constituted a national emergency, designed to fall with in the guidelines of PERP sans the political diatribe.
pan·dem·ic is a noun - an outbreak such as a disease
Prevalent over a whole country or the world.
@Chris thanks for some actual information.
Take a look at this link: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/html/2012-5312.htm (

find [[Page 13334]] One month prior to the government announcement declaring an emergency in 2012 Deleted were definitions of Pre-Pandemic and Pandemic - In-fact there are a number of deletions you may want to look at in considering your evaluation of whether this path is ethical.
Population - Geographic Area - Immunity - Effective time period -

This case law taken in consideration of the above deletions
http://www.courthousenews.com/2012/12/03/vaccine.pdf

I do not think the average American intended to waive their right to litigate unsafe medical practices as they may arise and have arisen over the history of our country. Products liability cases in fact is one of the things that has kept the citizens safe.

Unlike what that legal decision says, it is not limited to the contract vendors it also reaches anything they give you.

The decision is posted because the public doesn't understand that the law says they don't have to
1) tell you they are inoculating you, I am not speaking about a consent form for the flu; I am speaking in terms of the flu being used as the mechanism to advance other agenda's that may or may not constitute a health emergency: for instance much of the press you see regarding this outbreak is termed in context towards women who are pregnant. If you read through the healthcare act it describes pregnancy in terms of a health emergency many different ways
Data mining. This allows for the "surveillance of sexual activity for the purpose of targeting the individual who in terms of their "medical eligibility". They are very direct about the purpose and tie it to recommendations from the WHO
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm#box2 Most of the public is unaware their medical records are being used to direct WHO agenda's with their private medical records, they simply sign what ever they have to see a Dr.
Some people believe that their definition of an "unwanted pregnancy" is applicable to others.
Some actually believe that birthrates are tied to the economy. Despite the fact that statistics do not bear this out in my opinion. http://www.pewsocialtrends.org/2012/11/29/u-s-birth-rate-falls-to-a-rec… http://www.latimes.com/health/boostershots/la-heb-us-birth-rate-falls-t… and this constitutes a national security issue
2) there is very limited liability if any (ever try to beat the USA in court? not easy,)
3) few people realize their personal medical records are being mined for these purposes which in all fairness cannot be thought of in terms of medicalization http://en.wikipedia.org/wiki/Medicalization

Considering the topic I am a little surprised to not see a mention of the study showing 1/3 male sperm count decline
http://www.medicalnewstoday.com/articles/253609.php
I don't find it unreasonable for patients to be concerned about agendas that don't take them personally into consideration. So the shaming of people who seek information to be informed or have concerns about their healthcare is rather silly.

I'll continue to look at that site Chris thanks for the link

I meant to say cannot be thought of without thinking in terms of medicalization

sorry for the long post and thanks for your info

Bo, your post is disjointed, rambling and very difficult to understand. I have no idea what you mean by getting something from the president, where you just plopped a Lancet abstract in the middle of a sentence. It is impossible to understand what context that Lancet paper was used without a reference to the full speech/whatever. I saw no indication that you had even read the Lancet link in your rant.

Here is an idea: Write out full grammatical sentences. Present an idea and provide the documentation for that idea. But make sure that idea is related to the article you are commenting on, not on other random medications, sperm count and other random thoughts.

I am not cognizant of legal matters, and from what I can see the 2012 links to legal stuff have nothing to do with Mr. Goldman's use of bad statistics. I do understand mathematics, which is how I caught that numbers taken for only a month do not include an entire year.

Also, the blog software puts a comment into moderation if you have more than two URL links. Stick to that limit.

@Narad

I didn’t take one month of data as an agenda.

I see this is going to go well. You're addressing the wrong person. Do excuse me for trying to find relevant portions of your rambling response.

The reason HIN reports it was Permavir is because that is what is in the case law in the pdf

No, it's because they lifted it from Courthouse News Service and slapped on a minor rewrite. No competent health reporter would commit that blunder.

I agree with you the alarm may be the way this law is structured as it provides conflict of interest to go unchecked.

It has nothing to do with "conflict of interest."

“cheap shot” ? 2 million women were exposed to Diethylstilbestrol when big pharma knew full well they were providing medicine that would cause miscarriage.

This has nothing to do, in any way, shape, or form, with the case that you're putatively talking about.

Accusing me of hindsight is ripe, I placed my post here hoping to find the data to support a seasons flu constituted a national emergency, designed to fall with in the guidelines of PERP sans the political diatribe.

This is hindsight, genius. Note that you in fact could construct a coherent argument on this front, which I will get to below, assuming that I am not rendered senseless trying to get there.

pan·dem·ic is a noun – an outbreak such as a disease
Prevalent over a whole country or the world.

Random dictionary quotations are de facto failure.

This case law taken in consideration of the above deletions
http://www.courthousenews.com/2012/12/03/vaccine.pdf

You are now simply emitting gibberish. You've already presented the "deletion."

I do not think the average American intended to waive their right to litigate unsafe medical practices as they may arise and have arisen over the history of our country.

Again, you're badly diluting what could be an actual point. I would like to verify that you have taken the trouble to inform yourself as to the default window of any triggering PREP declaration.

Products liability cases in fact is one of the things that has kept the citizens safe.

It's a mixed bag, but, yes, this is one of the ideas.

Unlike what that legal decision says, it is not limited to the contract vendors it also reaches anything they give you.

Please cite the portion of the decision that suggests otherwise. Or explain why... hey, wait, is it Black Helicopter Time?

The decision is posted because the public doesn’t understand that the law says they don’t have to
1) tell you they are inoculating you, ...

Cite the relevant provision and the putative mechanism for stealth inoculation.

... I am not speaking about a consent form for the flu; I am speaking in terms of the flu being used as the mechanism to advance other agenda’s that may or may not constitute a health emergency: ...

Ooh, "agenda's."

... for instance much of the press you see regarding this outbreak is termed in context towards women who are pregnant. If you read through the healthcare act it describes pregnancy in terms of a health emergency many different ways

The "healthcare act"? This is about PPACA now? Here I was hoping for the secret tetanus-sterilization conspiracy.

Data mining. This allows for the “surveillance of sexual activity for the purpose of targeting the individual who in terms of their “medical eligibility”.

OK, so let me get this straight: PREPA is all some sort of ruse for the sake of "data mining"? Or have you simply changing the subject for the hell of it? I mean, I can do that too, and I could keep it on point all the same.

They are very direct about the purpose and tie it to recommendations from the WHO
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm#box2

I'm sorry, but when did the CDC enter into this?

Most of the public is unaware their medical records are being used to direct WHO agenda’s with their private medical records, ...

I would imagine so.

... they simply sign what ever they have to see a Dr.

The concerns that you are now expressing in fact have nothing whatever to do with the consents signed at a physician visit.

Some people believe that their definition of an “unwanted pregnancy” is applicable to others.

OK. You might want to flesh this point out.

Some actually believe that birthrates are tied to the economy. Despite the fact that statistics do not bear this out in my opinion. [links omitted] and this constitutes a national security issue

Right. Again, you might want to flesh this out in a separate analysis, unless you're arguing in favor of influenza mortality, which you really could have gotten to some time ago.

2) there is very limited liability if any...

For what?

(ever try to beat the USA in court? not easy,)

You might want to check with commenter DJT, as he's an expert at this, or something.

3) few people realize their personal medical records are being mined for these purposes which in all fairness cannot be thought of in terms of medicalization [link omitted]

Yes, you've already said this. The exposition does not benefit from the repetition.

Considering the topic...

Oh, there's a topic now? Great!

... I am a little surprised to not see a mention of the study showing 1/3 male sperm count decline [link omitted]

First there is a topic, then there is no topic, then there is.... Oh, Juanita!

I don’t find it unreasonable for patients to be concerned about agendas that don’t take them personally into consideration. So the shaming of people who seek information to be informed or have concerns about their healthcare is rather silly.

Yah. See, laws are not personalized, and I don't know where the hell the "shaming" sign-off is from.

Here's how you could have advanced a coherent point about PREPA (not that I any longer believe that it was more than stage decoration in the first place), in rather fewer words: "The grant of authority to the Secretary of HHS to hand out liability exemptions, even if time-limited, is overbroad." See? Simple. It's possible to argue both sides of this, but at least it says something particular.

Eh, I'm in moderation.

@Chris the fact it hasn't dawned on you the study was cited at the point I directed you to in the presidents budget is telling. The study itself was worthless. The article is about what you clearly feel are unwarranted concerns. I examined your link and considered the information you have presented, which amounts to there must be a reason to be afraid of the flu because our government, big pharma, and the medical profession is above reproach,

After reviewing your link I am more convinced now there never was cause to inject the country with pharma products other than to move pharma products. Maybe there is a terror flu we should all be afraid of, but I haven't seen it. Despite the incredible amount of money wasted on the non-emergency.

Taking issue sentence structure used on internet discussion boards is classic. If you had no response to the concerns I raised, you would have been far more credible to simply say so.

@Narad you were far more effective with your first post which, I simply mis-read.

@Narad you were far more effective with your first post which, I simply mis-read.

So, that would be a big honking load of your not caring to have to bother to try to defend the content of your stream-of-consciousness epistle? It's not as though you couldn't have stuck to Parker.

Some of us have to work. The drug is being linked Guillain-Barre Syndrome. Despite the posters efforts to discredit that information. (which is a tad odd) The fact remains the Government felt the need to delete all the manufactures from the Statute remove the definition of a pandemic, and make it so vague it could apply to anything. So my guess is they know there are some problems with the drug by now. BigPharma has quite a lobby.

If you have some proof of a pandemic (which I doubt) or independent testing the vaccine that shows it is both safe and effective to be used on pregnant women, I figure by now you would have posted either but you haven't.

@Bo:

The drug is being linked Guillain-Barre Syndrome. Despite the posters efforts to discredit that information.

Link to Guillain-Barre Syndrome by who? Proper medical researchers? Or internet muck-rakers?

The fact remains the Government felt the need to delete all the manufactures from the Statute remove the definition of a pandemic, and make it so vague it could apply to anything.

Umm, what? You're not making yourself at all clear. Please articulate better.

If you have some proof of a pandemic (which I doubt) or independent testing the vaccine that shows it is both safe and effective to be used on pregnant women, I figure by now you would have posted either but you haven’t.

Wait.

Accusing me of hindsight is ripe, I placed my post here hoping to find the data to support a seasons flu constituted a national emergency, designed to fall with in the guidelines of PERP sans the political diatribe.

You still don't seem to understand that the best possible response to an emergency is to see it coming and avert it before it becomes a complete disaster. You are trawling through the data, saying "What, only 34 cases in a month and only 11 of those were severe enough to need hospitalization? That's not a disaster, therefore it clearly wasn't an emergency!" Ignoring the fact that "not a disaster" is exactly what a very-successfully-handled emergency looks like.

Bo:

The drug is being linked Guillain-Barre Syndrome.

Citation needed. Be clear which drug, and provide the title, journal and date of the PubMed indexed study showing that this unnamed drug causes more GBS than actually getting influenza.

Now find a topic, preferably one that has to do with the subject of the article (bad statistics using self-selected survey data), and stick to it.

A Canadian study by Phillipe De Wals, Lavall University Quecbec, looked at Guillain Barre incidence following immunization with the 2009 H1N1 flu vaccine, tracking new cases over the 6 months following the vaccine's introduction. With about 4 million Quecbec residents immunized 83 new GB cases occurred. Of these 25 occurred in people who had been immunzied within the prior 8 weeks.

De Wals calculated that for every 1 million people vaccinated, a two extra people could develop Guillain Barre. Further, the increased risk was only seen in people aged 50 or older.

That's a 0.0002% increase in the risk of GB.

Forgive me if I'm not exactly quaking in my boots (despite being over 50).

Here's the cite:

"Risk of Guillain-Barré syndrome following H1N1 influenza vaccination in Quebec", De Wals et al, JAMA. 2012 Jul 11;308(2):175-81

@Chris there is no proof a pandemic which makes this article as worthless as a bio-terror for profit vaccine. Pandemic never happened.

the economy is hurting try getting a job producing something

there is no proof a pandemic which makes this article as worthless as a bio-terror for profit vaccine. Pandemic never happened.

You might want to actually learn what the word means.

Bo, answer the question that was asked about the incidence of GBS with the vaccine versus the background rate. You made a claim, now you need to provide the evidence.

Explain how the vaccine induced GBS was greater than the over 300 pregnant women hospitalized with influenza with over seventy deaths, and the deaths of over 280 children. Be sure to provide actual citations. Here is an example citation:
Vaccine. 2012 Nov 19;30(49):7123-9. doi: 10.1016/j.vaccine.2012.09.032. Epub 2012 Sep 26.
Autoimmune disorders after immunisation with Influenza A/H1N1 vaccines with and without adjuvant: EudraVigilance data and literature review.

As Narad says, you need to learn what the word "pandemic" means. Here is a timeline that shows the start in Mexico and then spread to all of the Americas and then Europe, Asia, Australia and parts of Africa. There are 32 pages of cites in PubMed about it, you might wish to check this one out:
J Infect Public Health. 2012 Aug;5(4):286-96. doi: 10.1016/j.jiph.2012.04.001. Epub 2012 May 22.
Did pandemic preparedness aid the response to pandemic (H1N1) 2009? A qualitative analysis in seven countries within the WHO European Region.

By the way, my job is taking care of my disabled son. He had seizures from a now vaccine preventable disease. In the future try using full grammatical sentences, and citing actual evidence. That is more effective than insults in a discussion.

Bo:

bio-terror for profit vaccine.

Go to page 30 of this pdf report. Look at the table and the tell us what number is to the left of the word "Vaccines," Explain what it means, using full grammatical sentences and not Dada poetry.

Please don't provide any more citations for GBS and influenza vaccines. I'm enjoying the show and how Bo has painted himself into a corner.

Claiming that a flu vaccine is unneeded because we didn't have any major epidemics while we were using it is like claiming a fire code is unneeded because there have been no major fires since it was adopted.

Surely more paint can't hurt...

Considering the topic I am a little surprised to not see a mention of the study showing 1/3 male sperm count decline

Considering the topic I am a little surprised to not see a mention of the bar codes on the backs of road signs.

You still haven't established the proof of a pandemic could it be you can't?

Bo,

To show us that you know what you're talking about, please provide the definition of "pandemic" as you understand it.

Actually I did. First off, the words with blue letters are URL links. Hover your mouse over the words and when the pointer changes to a little hand click the button on the mouse.

Also, there is a reference to PubMed, where there are over thirty pages of just review articles. I listed one.

It seems that your issue is a lack of basic literacy. It could be that English is not your native language, or it could be that you are being deliberately obtuse. If it is the latter, then you are acting like a troll.

Bo:

You still haven't established that you would recognized proof if it hit you in the butt with a bass fiddle; could it be that you can't?

@Chris

The elusive definition of pandemic influenza - Peter Doshi
http://www.who.int/bulletin/volumes/89/7/11-086173/en/index.html#R5
"Central to this debate has been the question of whether H1N1 influenza should have been labelled a “pandemic” at all. The Council of Europe voiced serious concerns that the declaration of a pandemic became possible only after WHO changed its definition of pandemic influenza. It also expressed misgivings over WHO’s decision to withhold publication of the names of its H1N1 advisory Emergency Committee. ...

At stake in this debate are the public trust in health officials and our collective capacity to respond effectively to future disease threats....."

Earlier I provided you with this link that indicates the US has now abandoned the definitions and phases.
http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/html/2012-5312.htm

Sorry I"n not able to clarify subjects with the use of italics. (I'll look for an app.)
"By the way, my job is taking care of my disabled son. He had seizures from a now vaccine preventable disease." My response to this is would be my mother is dead as a result of experimental use of drugs by "health professionals" something that was also entirely preventable.

The elusive definition of pandemic influenza – Peter Doshi

Finally, you're making some progress. Try one more step.

Oh, right.

Earlier I provided you with this link that indicates the US has now abandoned the definitions and phases.

This episode of the Federal Register does not demonstrate any such thing.

Bo,

My response to this is would be my mother is dead as a result of experimental use of drugs by “health professionals” something that was also entirely preventable.

I'm sorry about your mother, but I don't understand what you are asserting. Are you saying that a doctor high on drugs killed your mother? Or that she was treated with drugs as part of a clinical trial and died? If the latter, how do you know it was the drugs that were responsible for her death, and not the underlying condition she was being treated for?

The post above illustrating the problems with definition should be @Todd W. and the last portion @Chris

Bo,

Okay, so what is the definition of "pandemic" as you understand it? How do you define it? Once we know how you define it, then we can start meaningful discussion on the bigger question at hand.

@Narad

To assist you search deleted after you open the link. And yes I am aware of the article written in opposition the Peter Doshi's.

"When I use a word," Humpty Dumpty said in rather a scornful tone, "it means just what I choose it to mean -- neither more nor less."

"The question is," said Alice, "whether you can make words mean so many different things."

"The question is," said Humpty Dumpty, "which is to be master - - that's all."

@Todd W.
what is the definition of “pandemic” is the point. The WHO has re-defined it. The United States followed that definition and then removed it from the statute.

To assist you search deleted after you open the link.

Thanks, but I'm able to read. It has nothing whatever to do with the WHO phases. It's administrative housekeeping about the language used to define liability protection after a triggering PREPA declaration. These have never constituted what is and is not a pandemic.

@Bo - that wasn't the question. Todd asked what "YOU" consider the definition of a Pandemic to be....care to answer?

Once we know how you define it, then we can start meaningful discussion on the bigger question at hand.

You mean FREEDOM?

@Lawrence To answer your question NO I wouldn't seek to define the term Pandemic.

However, it is commonly understood as: An outbreak of such a disease. Prevalent over a whole country or the world.
Hence the problem Peter Doshi’s points out.

@semantics noted it is the legal vehicle authorizing the inoculations without consent and limiting liability

The vagueness of the revisions may make it void were this to be challenged at a higher level. We won't know the answer to that question until someone can afford that battle takes it up.

Surely as bright of minds posting on this board can see the potential for abuse. There are legitimate questions about how this law can be applied.

The article is written and the discussion following seems to advocate the shaming of people who ask questions about their healthcare. A point that seems rather silly considering the difficulty WHO and the US has had in defining a seasons flu as a pandemic.

@Bo

So you won't tell us what you consider to be a "pandemic"? If we don't know how you define it, how can we make any sense of your claim that there was no pandemic? We need to all be using the same definitions to have any meaningful discussion.

Do you accept the common definition of "an outbreak of a disease prevalent over a whole country or multiple countries"? Is that a legitimate definition of a pandemic? If not, then please let us know what you consider to be a legitimate definition.

@semantics noted it is the legal vehicle authorizing the inoculations without consent and limiting liability

Wrong again. There is no such "authorization." As I said originally, it's perfectly possible to craft a sensible argument against PREPA. Wandering around making severely confused statements about pandemics is not one of them.

^ There should be a "ways" in there somewhere, but I hope the meaning is clear.

@Todd W. We need to all be using the same definitions to have any meaningful discussion.- Bingo

@Narad I absolutely agree. Getting you to admit that in writing on a public forum is proof the Socratic method of teaching isn't dead. :)

Catch ya later!

Getting you to admit that in writing on a public forum is proof the Socratic method of teaching isn’t dead.

I'm the one who said it in the first place, and you apparently also don't understand what the Socratic method is.

Public health officials have to make a judgement call on when to institute measures to prevent or at least minimize the impact of a disease like H1N1. Even with the mass vaccination program, as Chris pointed out there were, "over 300 pregnant women hospitalized with influenza with over seventy deaths, and the deaths of over 280 children". H1N1 killed more than 18,000 people worldwide. How much worse would it have been in the US if a large proportion of the population had not been vaccinated? Bear in mind that vaccination adds herd immunity, so it didn't just prevent deaths in those vaccinated, but the deaths of a proportion of those who they would have infected and so on.

If there had been a serious outbreak of H1N1 in the US, with thousands of deaths, Bo or someone like him would be here alleging that people were allowed to die in pursuit of some New World Order population reduction program. People in public health can't win. If they prevent a pandemic they wasted money on nothing, and if they didn't prevent it they were ineffective.

Bo is going into all sorts of semantic machinations to avoid answering my two questions. It does not matter there was an influenza pandemic in 2009. That particular flu did kill over 280 children, and affected hundreds of pregnant women (with at least 75 deaths) in the United States of America. I suggest that he is now just trolling, and be ignored until he answers both questions.

First he must produce the titles, journals and dates of the PubMed index studies that show GBS with the H1N1 vaccine was greater than the background rate.

Then he must open this pdf document and tell us what number is to the left of the word "vaccines." Plus he must clearly explain what it means.

Reading Bo's comments, I'm left with the feeling that he is trying to say that the mass vaccination campaign against H1N1 caused more harm than good. However, his vague remarks and comments don't cogently argue his point.

IMO, Bo is clueless about the complicated process of deciding which three of the many circulating strains of influenza viruses, will be manufactured for the seasonal influenza flu season six months forward. (S)he is also clueless about the resources at the CDC, the WHO and other countries throughout the world that are devoted to global influenza surveillance, testing of specimens, detecting antigenic drifts and antigenic shifts.

http://www.cdc.gov/flu/professionals/vaccination/virusqa.htm

The manner in which laboratories were able to effectively identity the H1N1 strain and the manner in which pharmaceutical companies were able to produce the H1N1 vaccine to provide the vaccine to select high risk groups in a relatively short time span, is a success story and a tribute to our public health surveillance teams, laboratory technology and capacity and yes, *Big Pharma*.

Here's the H1N1 pandemic swine flu timeline...

http://en.wikipedia.org/wiki/2009_flu_pandemic_timeline

Back in the 80s I remember seeing hospital wards full of head injury patients, but people hardly ever hurtle through their windshields in road traffic accidents any more. Its time to stop bothering with seat belts and airbags, as they are clearly an unnecessary expense.

You still haven’t established the proof of a pandemic could it be you can’t?

Nah, the proof is adequate however you are amazingly faltering even with the benefit of hindsight. H1N1 fulfilled the definition of pandemic, the problems that arose were the subsequent categorising of the severity and levels.

The article is written and the discussion following seems to advocate the shaming of people who ask questions about their healthcare.

Oh quit your whining. If you feel ashamed then it's your own fault for arrogantly ignorantly banging away on "evidence" that isn't there and ignoring the more mundane evidence of errors that are there.

@Bo

@Todd W. We need to all be using the same definitions to have any meaningful discussion.- Bingo

So, are you going to answer my questions? Here they are again so you don't have to go scrolling backup.

Do you accept the common definition of “an outbreak of a disease prevalent over a whole country or multiple countries”? Is that a legitimate definition of a pandemic? If not, then please let us know what you consider to be a legitimate definition.

@Todd W. I answered this question in response to Lawrence above, but rightfully so you may have asked the question first the thread is long. Here was my response:

@Lawrence To answer your question NO I wouldn’t seek to define the term Pandemic. However, it is commonly understood as: An outbreak of such a disease. Prevalent over a whole country or the world.

Hence the problem Peter Doshi’s points out. (in his article The elusive definition of pandemic influenza (Submitted: 13 January 2011 – Revised version received: 30 March 2011 – Accepted: 31 March 2011. Bulletin of the World Health Organization 2011;89:532-538. doi: 10.2471/BLT.11.086173 )

I also posted a link to where the Fed. Reg deleted the definitions (On Tuesday, March 6, 2012). (only posted those two links because a poster requested I limit the links in my response to 2), The purpose 2nd link of that post was to demonstrate the resulting action by the government to the problem of how to frame a pandemic was to (delete the definition and phrases which leaves the definition legally vauge and applicable to a wide range of interpretation). The previous language can be found by searching for hhspandemicinfluenzaplan

Following that response Narad very astutely posted the article by Heath Kelly written in response to Doshi. Bulletin of the World Health Organization 2011;89:540-541. doi: 10.2471/BLT.11.088815

The import of these two well written articles is that there is indeed a controversy over how to frame a pandemic. From a medical perspective.

The resulting legislation following the controversy is problematic from a legal point of view. I recommend reviewing those two articles to help understand.

The purpose 2nd link of that post was to demonstrate the resulting action by the government to the problem of how to frame a pandemic was to (delete the definition and phrases which leaves the definition legally vauge and applicable to a wide range of interpretation).

Like I told you, you don't understand what you're reading. Removing section X has exactly nothing to do with the definition of a pandemic, it has to do with the definition of a Covered Person under PREPA.

As to the "proof" that you were demanding, little more is needed than this.

Bo, you are not to make anymore demands until you answer these two questions, which I am now restating for at least the third time:

Provide definitive evidence that the rate of GBS from the H1N1 vaccine in 2009 was much higher than the background rate. Something that directly disputes and is as thorough as what I posted above, Vaccine. 2012 Nov 19;30(49):7123-9. Provide the PubMed indexed paper.

Then go to Page 30 of this pdf document, look at the table and tell us what number is to the left of the word "Vaccines." Then explain clear what it means.

Remember the blue lettering is a URL link, just hover your mouse over the blue words and click the link. Proceed to the 30th page and read the table. Surely you are able to do that one simple task?

To answer your question NO I wouldn’t seek to define the term Pandemic. However, it is commonly understood as: An outbreak of such a disease. Prevalent over a whole country or the world.

No one asked if you would seek to define the term 'pandemic', bo: what you've been asked is what exactly you mean when you use the term.

Do you also understand pandemic to mean 'an outbreak of such a disease, prevalent over a whole country or the world"? If not, what instead do you mean when you use that word?

@lilady:

The manner in which laboratories were able to effectively identity the H1N1 strain and the manner in which pharmaceutical companies were able to produce the H1N1 vaccine to provide the vaccine to select high risk groups in a relatively short time span, is a success story and a tribute to our public health surveillance teams, laboratory technology and capacity and yes, *Big Pharma*.

Amen to that.

And Bo, stop wasting everyone's time with your copy-pasta BS. My entire family caught H1N1 at the same time a few weeks after it landed in Canada - before the vaccine was available. We were lucky to have minimal complications but my husband, my child and me were all very ill for over a week -- and the hospitals in our city were filled with people on ventilators who weren't so lucky. If I'd the choice, the vaccine would have been vastly preferable.

There's no question that it's a tough call for public health authorities whenever there's a mass outbreak of something new --my personal belief is that it's better to overprepare for an emergency than scramble after it's gotten out of control. You are plainly not interested in a good-faith debate about the merits of compulsory vaccination though, you'd rather play silly games with the definition of 'pandemic.' Stop JAQing off in public.

@Narad

Your link doesn't work.

Your link doesn’t work.

Dagnabit. Second try.

@Narad
Still railing about VAERS ..... lmao

You aren't being honest with yourself about the problematic disease mongering going on in medicine today. Your narrow view of of the medicalization problem impacts your credibility. Of course profit often leads to confirmation bias in the field of science. Many SSRI drugs are known to cause suicidal/homicidal ideation it is a fact.

Shameless... would be complaining about articles that might impact pharma profits while ignoring the death of 28 people in one event. There are thousands of events: ssristories.com

@Narad
Still railing about VAERS ….. lmao

If you're going to squirt out of the woodwork after nearly a month, the least you could do is not screw it up. I have no need to "rail" about VAERS, much less "still" rail about it.

Bo, could you at least learn the difference between vaccines and SSRI drugs?

hehe@Chris vaccines and SSRI are equatable they both are inventions that by Design create never ending profits

just saying hello Narad :)

@Bo:

hehe@Chris vaccines and SSRI are equatable they both are inventions that by Design create never ending profits

Seriously dude? Pharmaceutical companies make very little from vaccines. They'd make far more if there weren't vaccines. Then, most people would get the diseases and would have to pay for medicines to treat the diseases.
Prevention is not only better than cure, it is far cheaper.

"Then, most people would get the diseases and would have to pay for medicines to treat the diseases." = BioTerror for profit and experimentation.

Oh please save us! Just send the bill my tax accountant

At this point, Bo, you will now need to provide citations. Because you are not making any kind of sense.

Oh please save us! Just send the bill my tax accountant

I'd say that the odds of your having a tax accountant are rather slimmer than those of your being able to successfully put together an English sentence.

@ after your difficulty with defining the term "pandemic" you'd think you would have stopped making demand for information you can't comprehend. How is your flu symptoms doing after the holidays? I hope you feel better.

@Bo:

BioTerror for profit and experimentation.

Um, are you seriously suggesting that vaccines cause injury, thus making bigger profits for the manufacturers? If so, then medical insurers would have to be in on it, which makes no sense. Discovery (my insurer) pays for me to get inocculated.

Thank goodness for the internet grammar police, it keeps the aggressive progressives employed as bloggers..

Yes it is cheaper for insurance to regulate your body and your "health" Julian. what part don't you understand? Do you have any idea what they inoculated you for/ or with?

Certainly you are still capable of understanding that the marriage between government/pharma/insurance creates more than a few interests that may conflict with your personal health. That concept requires minimal tin foil for a science blog, that prides itself on critical thinking.

Pharmaceutical companies are in cahoots with insurance companies to make people sick so that insurance companies will have to increase the amount of money they pay to pharmaceutical companies. And the government is in on it because sick people are less productive and create an increased demand on services for which there is less tax revenue because of the drop in productivity.

Oh, that makes perfect sense.

Thank goodness for the internet grammar police, it keeps the aggressive progressives employed as bloggers..

I'm not a "blogger" or a "progressive," Peaches. Indeed, you might note a complete lack of grammatical complaints iin the foregoing, as opposed to the general observation that you seem to have difficulty making a coherent sentence.

(Which is no doubt an irritation to your "tax accountant.")

@daraN

You know lawyers don't pay taxes.

Jeezums, that's the dumbest deliberate misspelling I've encountered yet.

Sometime before Christmas I noticed a post to Orac seeking his opinion on the information on webpage. Unfortunately I missed any of the replys and have lost the thread. I saved the link however possibly Narad or someone else remembers the thread about this link?
http://thinkingmomsrevolution.com/how-the-zimmerman-report-affects-us-a…

You know lawyers don’t pay taxes.

Oh they don't, do they? Any lawyers care to comment?
@Shay: thanks for so accurately summarising the stupidity of Bo's argument.

pander
pan·der [pan-der] Show IPA
noun
1. a person who furnishes clients for a prostitute or supplies persons for illicit sexual intercourse; procurer; pimp.
2. a person who caters to or profits from the weaknesses or vices of others.
3. a go-between in amorous intrigues.
verb (used without object)
4. to act as a pander; cater basely: to pander to the vile tastes of vulgar persons.
verb (used with object)
5. to act as a pander for.
http://newyork.cbslocal.com/2013/01/10/farley-severe-strain-of-flu-reac…

*Thank you Peter Doshi at least they didn't call it a Pandemic :)

pan·der [pan-der] Show IPA

I am glad to see this thread turning to the topic of beer.

@HDB - always love a good IPA, though the entire Ale family gets my respect as well.

I used to brew batches of beer. The place had a nice recipe for Xmas Ale and a stout as I remember.

@Bo: at the risk of feeding the troll: you're a joke. The link you posted about NYC is exactly what most of us expect to read: flu is widely spread (no one is calling it a "pandemic" as IIRC the requirements for the true definition haven't been met yet).

And according to the article, the best ways to protect yourself are: get the flu shot, wash your hands often, stay home of you are sick.

Why do you think we wouldn't support all of these steps? Yes, I got my flu shot back in November. This week, I've been mildly sick with flu like symptoms (fever, muscle aches, headache). I've had the full-blown flu in the past. I'll happily take the mild illness i have now (which may or may not be flu related) over the full-blown (fever for days, severe muscle pain, blinding headaches, vomiting, diarrhea) flu.

ARGH! It should have said : "I'll happily take the mild illness I have now (which may or may not be flu related) and the flu shot over...

Like who cares what Bo thinks...he's widely off topic.

Clearly bo lives in opposite land, where curing or preventing illness represents bioterrorism.

Bo, how are Luke and Daisy, anyway?

(and I apologize for insulting such a classic TV show through association with such a classic troll)

@Bo

"You know lawyers don’t pay taxes." I already knew the answer but in the interests of research I ran this one by my brother-in-law the lawyer/CPA. As with everything you have posted so far, not true in any known universe.

I'm married to a lawyer and we pay taxes. :-)

Dear Sheeple,
Big Pharma can save you. Treatments are available for your Irrational fear of the flu, your ephebiphobia and your Coulrophobia
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001926/
Be sure a read the labels though some of these "treatments" are problems in and of them self. If you have a problem with one of these drugs report it to your health professional and he will then start you on a new drug that can cause you a different set of problems and side effects. As you can imagine, treatment and side effects can be a tad expensive so be sure and insurance up before you begin the never ending journey of the pharma solution.

While visiting your doctor take care to avoid touching anything and use a hand sanitizer because as you know sick people go to the Dr.
http://www.cdc.gov/handwashing/
(This message is brought to you from the "Be afraid Society" a non-profit organization dedicated to spreading BS, because we are concerned for your health)

Did you recently get released from the county psyche ward?

Big Sanitizer is just raking in the dough from all that handwashing propaganda I guess

Bo, I'm not sure what you're trying to say.

Are you arguing that obsessive complusive disorders aren't real? Or perhaps that treatment with SSRI's or tricyclics do not provide many individuals releif from symptons of OCD?

Are we expected to be surprised that drugs may have side effects, or that healthcare is expensive?

I mean, you've used a lot of words there, but you don't seem to actually have said anything of consequence.

Flu Deaths at Epidemic Level, but May Have Peaked
New York Times - 49 minutes ago

"May Have Peaked" <---- lmao Peter Doshi strikes again :) they should call this the Doshi Disclaimer in advertising media aka "the news"

@ Chris...I think he is self-medicating himself...bath salts?...ETOH?... brake fluid?

Maybe it is Brave Sir Robin or BSR Jr.?

"Maybe it is Brave Sir Robin or BSR Jr.?" <--Oh know a batman conspiracy reference! Sandy Hook - Bio Terror and the Dark night rises

http://www.pakalertpress.com/wp-content/uploads/2012/12/Sandy-Hook-Refe…

The Marketing of Madness
http://youtu.be/uFkivsEy3CI

I'm not saying all vaccines are bad or that they don't have some application. However the medical industry science and pharma marketers embedded in government should take heed of Aesop.

I'm guessing THC and embalming fluid

pharma marketers embedded in government

Please, do expand on this.

“Maybe it is Brave Sir Robin or BSR Jr.?” <–Oh know a batman conspiracy reference! Sandy Hook – Bio Terror and the Dark night rises"

Guess again Bo.

"pharma marketers embedded in government"

Pharma marketer's with embedded computer chips in the brains, placed their by *Big Gubmint*?

Dear Sheeple,

You lose.

Treatments are available for your ... Coulrophobia

No, I'm not afraid of you. I'm pointing and laughing.

@bo

Please keep posting. I am having a laugh at the utter idiocy and stupidity that you continue to show to the world. I like an idiot who cannot make a half-coherent argument, and you seem just like the perfect fool for some laughs.

You know what's funny about all the usual tropes about being given more meds to deal with the side effects of other meds?

In my entire life, every time the side effects of the original med was too great, I was only ever switched to a different med. I've never had prescriptions piled on to deal with other prescriptions. In fact, if this kind of thinking were true, instead of avoiding medications I'm allergic to my doctor would keep me on them and add others to cancel out the allergic reaction.

Instead, do you know what the doctor does? Finds another medication that doesn't cause an allergy but does the same thing to treat my illness.

Anyone have any stats on the true nature of polypharmacy? Is it as high as the conspiracy theorists portray?

flip,

Anyone have any stats on the true nature of polypharmacy? Is it as high as the conspiracy theorists portray?

Cochrane has something to say about this:

In the USA, the prevalence of polypharmacy, defined by Kaufman as five or more medicines, in older people was approximately 7% (Kaufman 2002) and individuals over 65 years of age, who constituted less than 15% of the American population, purchased 33% of prescription medicines and 40% of over-the-counter (OTC) medicines (Werder 2003). In 2007, people of 65 years and over constituted 16% of the UK population, yet consumed 43% of all National Health Service (NHS) resources in 2003 to 2004 (Philp 2007). The average number of medicines prescribed for people aged 60 years and over in England has almost doubled from 21.2 to 40.8 items per person per year over the past decade (Information Centre 2007).

The main cause is multimorbidity i.e. multiple medical conditions that each require medication, an increasing problem in an aging population, not treating the side effects of other drugs. That of course leads to the possibility of unexpected drug reactions among other problems. This is a recognized problem that is being addressed - but the conspiracy theorists don't have any useful solutions, of course.

The Social Construction of Illness
http://hsb.sagepub.com/content/51/1_suppl/S67.full

"In my entire life, every time the side effects of the original med was too great" another "success story" for http://www.customerforlife.com/

Anyone else here a "customer for life" ? Post your story

The deranged one is still posting here with his inanities.

Here are some pictures of the real "Bo"...enjoy.

https://www.google.com/search?q=pictures+of+Bo+obama&hl=en&client=firef…

@lilady

Are you pill free?

(no need to disclose your personal issues a simple yes or no will suffice)

@lilady - seems Bo is planning on giving insano-troll a run for its money with his inanities.

The Social Construction of Illness

Having studied medical anthropology and read and written more than I care to remember about the cultural construction of illness, I don't think this means what Bo thinks it means.

Having studied medical anthropology and read and written more than I care to remember about the cultural construction of illness, I don’t think this means what Bo thinks it means.

I've already had my share of postmodernist hilarity for the week, I'm afraid. (Note to HDB: Seriously, the Galloway Critical Inquiry piece is a riot.)

@ Lawrence...now that Insane Troll has moved on to other science blogs to post her inanities under various sock puppets, I think I will dub this troll as "SFB Troll".

Don't for get your meds! ;)

Thanks Krebiozen. I took a very short view at the Wikipedia entry on polypharmacy, but have bookmarked your link for further reading when I have more time.

@Bo

Nice non sequitur. And a 'success' story? About what exactly? My doctor managing to avoid making me ill by prescribing me something I *wasn't* allergic to, as compared to the whole bunch of other times when doctors couldn't figure out what was wrong with me and prescribed the wrong meds? I've had both happen to me you know. (And yet, still no polypharmacy!)

But I suppose, that would mean I live in a world that isn't black and white and that doesn't suit you at all...

However the medical industry science and pharma marketers embedded in government should take heed of Aesop.

This should be good. Do go on.

In my entire life, every time the side effects of the original med was too great, I was only ever switched to a different med. I’ve never had prescriptions piled on to deal with other prescriptions. In fact, if this kind of thinking were true, instead of avoiding medications I’m allergic to my doctor would keep me on them and add others to cancel out the allergic reaction.

Your doctor(s) would only do this only if they recognized and acknowledged that you were indeed experiencing side effects or adverse reactions. If they were not trained well enough (I'm inclined to say grossly incompetent and negligent), or if it would not be in their best interest (want to string you along as a perpetual paying patient), then they would not intervene or otherwise take appropriate action.

This type of over-medicating is a problem, at least in some areas. I don't have statistics. I only say it is a problem because I see it happening to quite a few people. Any deaths and any livelihoods, careers and families lost or destroyed from what I consider this type of reckless, irresponsible prescribing are too many. I think the majority of the problem lies in the interactions of the drugs, not necessarily with any single medication. Although some medications are clearly more easy to overdose on than others and still others pose greater risk for interactions.

Bo, if you've had problems with medications, then you are not doing anyone any favors by running around ranting like an irrational lunatic, and certainly not to this crowd. It also may have the effect of impeding recognition of such problems, because no one is going to take anything you say seriously and people may assume anyone making similar complaints is equally irrational.

I too love a good Aesop tale. Do go on.

Seriously, the Galloway Critical Inquiry piece is a riot.

I hadn't come across that (the link you left at Riddled was truncated).

So the current ascendancy in the software world of object-oriented languages establishes some profound truth about late capitalism and contemporary philosophy. Um, yes.
[backs away nervously]

So the current ascendancy in the software world of object-oriented languages establishes some profound truth about late capitalism and contemporary philosophy. Um, yes.
[backs away nervously]

Sorry about the link. In any event: (1) I have a strong suspicion that Phil Agre, who was very kind to me in my last year of grad school, would suggest that, yes, it is "too much of a stretch to say that the contemporary mode of production has a very special relationship with object-oriented computer languages" something something steam engines (p.352). (2) If one were to look for the ultimate subject-oriented language, it's APL time! Long the favored tool of... the Census Bureau. I see no other escape, as procedural languages are Not Freedom.

At least it has been established by implication that Emacs wants to be a Tool of the Man.

yes, it is “too much of a stretch to say that the contemporary mode of production has a very special relationship with object-oriented computer languages”

The analogy that occurred to me was double-entry bookkeeping... one might as well argue that one particular error-minimising convention of accountancy is an integral part of Colonialism. However, a few seconds of Googling revealed that any number of post-modernist critics have made precisely that argument.

I should note that I failed to mention that object-oriented languages have classes and inheritance. Procedural languages do the same thing by assiging types.

You think the name Simula wasn't a tip-off? Al Gol? What does that sound like? Heh, sherson.

^ "assigning"

I'm further upset that the typesetting on this is frankly crappy given the level of difficulty, but let's plod on. Monsanto? Software company. Software? "The thorn in the side of contemporary philosophy."

You want a thorn in your side? Try getting the Penta installation that's churning out your effort direct to plate not to curl up into a ball in the corner every four hours.

Oh when the Kant comes marching in
When the Kant comes marching in
Oh, L-rd, I want to be in that number
When the Kant comes marching in

Of course there is a long debate in philosphy around the origin of math. Does number come from the world, as in the case of one's ten fingers; or is it a pure concept, as in the notion of triangleness?

Risking their health while caring for others: Reproductive health hazards of germ-killers

lborkowski — Fri, 09 Mar 2012 14:13:49 +0000

Risking their health while caring for others: Reproductive health hazards of germ-killers

by Elizabeth Grossman

Nurses face many hazards on the job, and one that clearly demands more detailed analysis than it's received to date is the effect of occupational chemical exposures on nurses' reproductive health. A recent study by researchers at the National Institute of Occupational Safety and Health (NIOSH), Harvard School of Public Health, and Brigham and Women's Hospital has found that female nurses exposed to sterilizing agents and chemotherapy drugs at work are at least twice as likely to have miscarriages than those who are not. The study, published in The American Journal of Obstetrics and Gynecology, surveyed more than 7,000 female nurses and found that their exposure to sterilizing agents was associated with a two-fold increase in the risk of miscarriage between the 12th and 20th weeks of pregnancy. Exposure to chemotherapy drugs was associated with a two-fold increase in risk of miscarriage before the 12th week of pregnancy, while for women pregnant for the first time, this exposure appears to increase miscarriage risk three-fold. The study also found that exposure to x-rays was associated with some increased risk of early pregnancy loss.

Similar effects have been reported before, but this is one of the largest studies ever to look at these exposures, explained Christina Lawson, a reproductive epidemiologist with NIOSH and study author. Because these results reflect adjustment for a number of variables -- including age, hours worked, and shift-work -- and because the study was designed to avoid overestimation, its findings may be conservative, said Lawson.

The chemicals involved in the nurses' sterilizing agent exposures likely include ethylene oxide, formaldehyde, glutaraldehyde, hydrogen peroxide, orthopthalaldehyde, and peracetic acid, all powerful chemicals used to disinfect medical equipment and surgical instruments. Because the survey only asked nurses whether they were exposed, follow-up studies will be required to determine precisely which sterilizing agents nurses are being exposed to and exactly how they are affecting pregnant nurses, as well as what kind of protective and safe-handling measures nurses are using. But there is little, if any, uncertainty that these substances pose human health hazards. Here's an overview of what researchers have found:

Formaldehyde
Formaldehyde is recognized as carcinogenic and mutagenic. The authors of the new NIOSH nurses study note that other studies of formaldehyde's reproductive toxicity have been limited. However, a 2011 University of California Berkeley School of Public Health review of past studies found formaldehyde exposure to be associated with miscarriage, as well as other adverse reproductive and developmental health effects. A 1994 study of exposure to formaldehyde-based disinfectants and manicure products among women who worked in beauty salons in North Carolina also found these exposures associated with miscarriages.

Ethylene oxide
Like formaldehyde, ethylene oxide is a recognized carcinogen and mutagen. Although the authors of the new study caution that previous studies on ethylene oxide's reproductive toxicity have had limited sample sizes, these effects have been documented in peer-reviewed studies, some dating back to the 1980s. Studies of nurses in South Africa, Finland and the US, and of dental assistants in California exposed to ethylene oxide have all found associations with miscarriage. A 1984 study estimated that 75,000 US healthcare workers were at that time exposed to ethylene oxide and pointed out that in animal studies this chemical has been shown to cause birth defects, fetal loss, and reduced fertility (both male and female). That study also reported a human epidemiological association with leukemia and referenced an additional study that suggested brief occupational exposure to ethylyne oxide (twice daily at concentrations of 20 parts per million or more) among pregnant women increased risk of miscarriage.

More recently, a 2007 survey of 1,500 nurses undertaken by Environmental Working Group, Healthcare Without Harm, American Nurses Associations, and University of Maryland School of Nursing found that nurses exposed to sterilizing agents had a 20% higher incidence of miscarriage than those who were not. This survey - which specifically examined exposure to ethylene oxide and glutaraldehyde - also found increased incidence of birth defects in these nurses' children.

Orthopthalaldehyde
Orthopthalaldehyde (OPA), which was introduced as a less-toxic alternative to ethylene oxide and glutaraldehyde, is less extensively studied than the other commonly used medical sterilizing agents. However, a 2005 Canadian study of risks to healthcare workers from these exposures noted that OPA has similar structural and reactive properties to glutaraldehyde and acted similarly as a chemical sensitizer. Glutaraldehyde is also used as a hydrofracking fluid, and one such Material Safety Data Sheet (MSDS) warns that ingestion of "glutaraldehyde by pregnant women can cause reproductive toxicity to the fetus." OPA does not currently have a recommended exposure limit. A 2010 Johnson & Johnson MSDS for an OPA product says reproductive effects are unknown.

Formaldehyde exposure in both nursing and beauty salons
Studying the reproductive health effects of chemical exposures is particularly important in professions dominated by women, as nursing is. Another such field is hair and nail salon work, where formaldehyde exposure is a concern since formaldehyde and compounds that release formaldehyde have long been used in numerous cosmetic products.

The well publicized recent discovery of formaldehyde released by the use of Brazilian Blowout hair treatment has drawn attention to this hazard, but formaldehyde and formaldehyde-releasing chemicals have been used in many other beauty salon products. Although this product had no formaldehyde warning labels and some of this brand's products were labeled "formaldehyde-free," it was found to release hazardous levels of formaldehyde gas. A California lawsuit and a class-action lawsuit against the company have just been settled. The settlement requires new labels on products and MSDSs, but it does not require formaldehyde to be removed from the product.

But Brazilian Blowout is far from the only hair, cosmetic or personal care product to expose users to formaldehyde. The Occupational Safety & Health Administration (OSHA) lists about a dozen such hair products known to contain formaldehyde and that can cause formaldehyde exposure during use, even though they do not name formaldehyde on their labels or material safety data sheets. OSHA also lists more than two dozen other chemical compounds that can release formaldehyde - and so have comparable health risks and are subject to OSHA's formaldehyde rules - that are not called formaldehyde or methylene glycol (which is formaldehyde dissolved in water). Any such compound, because it is potentially carcinogenic requires a label if the product contains more than 0.1% of that substance. These two dozen formaldehyde-containing or releasing compounds have at least twice as many trade or other names, which may appear on ingredient labels or MSDSs. Some of these compound names are more than 26 letters long; some are simply initials. One of theses synonyms, Quaternium 15, turns up in 405 products listed on the Environmental Working Group's "Skin Deep" database of cosmetic and personal care product ingredients. Another, listed as DMDM, I've just found listed in the Organix brand hair conditioner in my own bathroom.

More questions about occupational exposure to the sterilizing agents, chemotherapy drugs, and other chemicals will be asked as part of the next Nurses Health Study, one of the largest and longest-running investigations of factors that influence women's health. The new NIOSH study on nurses' chemical concludes that "the effect of commonly encountered occupational exposures on reproductive health remains unclear within this predominantly female occupation." But the literature thus far appears to indicate that much more needs to be done to prevent these exposures.

Elizabeth Grossman is the author of Chasing Molecules: Poisonous Products, Human Health, and the Promise of Green Chemistry, High Tech Trash: Digital Devices, Hidden Toxics, and Human Health, and other books. Her work has appeared in a variety of publications including Scientific American, Salon, The Washington Post, The Nation, Mother Jones, Grist, and the Huffington Post. Chasing Molecules was chosen by Booklist as one of the Top 10 Science & Technology Books of 2009 and won a 2010 Gold Nautilus Award for investigative journalism.

lborkowski Fri, 03/09/2012 - 09:13