Respectful Insolence

Over the weekend, I chilled out a bit, at least as far as the blog was concerned. I won’t make too much of a secret of it, but thanks to the new policy of the new owners I have a decision to make. In the meantime, while I’m dithering, you, my readers, were deluging me with requests. Well, it wasn’t exactly a deluge. Maybe three or four e-mails. But, hey, over a dull holiday weekend, when I spend most of the time either working on a grant or working in my yard? That’s a deluge! Never let it be said, either, that I don’t give the people what they want (usually, at least). So what are the latest depredations, antics, silly statements, and outright flaming stupidities that have caused my readers to plead with me–nay, beg me–to unleash the hounds and provide a heapin’ helpin’ of that not-so-Respectful Insolence that you all know and either love or hate upon an unsuspecting advocate of pseudoscience?

Well, it starts with a website and blog known as SANE Vax.

If you’ve been in the biz a while, as I have, you can tell right away from the very name of this website exactly where its creators are coming from. Here’s a hint. It’s not the mission that the website claims that it is, which is stated thusly:

The Sane Vax Mission is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.


Oh, no. SANE Vax didn’t go and claim that its members believe in science-based medicine, did it? I wonder if Steve Novella knows that anti-vaccine activists are misappropriating the term he and I promote as how medicine should be based in science. Science-based medicine. You keep using that term. I do not think it means what you think it means. In any case, SANE Vax appears to be anti-vaccine to the core, which should be obvious from its name. Obviously, if its creators think they’re promoting “sane vaccination,” by implication they very likely think that the current vaccination schedule is not sane. Further supporting the rather mind-numbingly obvious conclusion that SANE Vax is indeed anti-vaccine are videos featuring Andrew Wakefield, Barbara Loe Fisher, and other luminaries of the anti-vaccine movement, as well as a Vaccine Victims Memorial, the latter of which is a page taken right out of the playbook of the National Vaccine Information Center (NVIC), one of the oldest anti-vaccine groups still in existence. Meanwhile, it’s list of “vaccine groups” contains all the usual anti-vaccine suspects, like the Australian Vaccination Network, Age of Autism, ThinkTwice, Generation Rescue, and Impfschaden (discussed just last week).

I also don’t believe for a minute that SANE Vax is, as it bills itself, a “vaccine safety” group. For one thing, in the comments of the two SANE Vax posts I’m about to discuss, Australian skeptic Peter Bowditch shows up to ask, “Which vaccines are “necessary” and “effective” to match the ‘N’ and ‘E’ in SANE?” He has yet to receive an answer. This fulfills one of my key criteria of an anti-vaccine activist in that when, after hearing her piously pontificate that she is “not anti-vaccine,” you ask her which specific vaccines she supports and get either no answer or dancing around the question with no real answer.

So what’s got SANE Vax in an uproar? DNA. But not just any DNA. Recombinant DNA. But not just any recombinant DNA. HPV recombinant DNA. Take a look at some posts that appeared on the SANE Vax blog over the weekend and very early this morning:

Oh, noes! DNA! The horror…the horror.

Does this sound familiar? It should. It’s almost exactly the same fear mongering nonsense that Joe Mercola and Helen Ratajczak used to try to claim that homologous recombination of fetal DNA in vaccines with the DNA in babies’ brains resulted in autoimmune inflammation that led to autism. In this case, the vaccine is the HPV vaccine, but the arguments are merely a variation on the same stupid theme. Here’s what SANE Vax is claiming:

SANE Vax Inc. contracted with an independent lab to test for contamination and found HPV recombinant DNA (rDNA) in 13 vaccine vials. The Gardasil vials with different lot numbers were from New Zealand, Australia, Spain, Poland, France and three states in the U.S. 100% of the samples tested positive for the presence of the genetically modified HPV DNA.

Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory well-known for using cutting-edge DNA sequencing for molecular diagnoses, was initially contracted to examine a single sample of Gardasil for possible contamination. This sample tested positive for recombinant HPV-11 and HPV-18 residues, both of which were firmly attached to the aluminum adjuvant.

Wow. Sounds pretty scary, doesn’t it? Actual HPV DNA! But not just any DNA. Oh, no. We’re talking recombinant HPV-11 and HPV-18 residues, which–horror of horrors!–were attached to the evil aluminum adjuvant! Stop the factories! Stop injecting our little girls with that evil vaccine whose only purpose is to encourage them to go out and have unprotected sex, knowing that they won’t get HPV!

Now hold on just a minute.

Let’s take a look first. First of all, one notes that there is not a single scientific paper–or even scientific report–describing the methodology used and the specific tests used. Oh, sure, in SaneVax’s letter to the FDA, Norma Erickson provides an actual picture of an actual graph from an actual DNA sequencing run in order to look all science-y, but then she also says:

The SANE Vax Inc. data, including the electropherograms of short target sequencing used to validate the HPV DNA detected in the thirteen (13) Gardasil samples, each with a different lot number, are available for your review, provided appropriate safeguards are in place to protect the proprietary processes and information utilized by our laboratory to test the samples.

Protect the “proprietary” processes used to test the samples? Why on earth does the Milford Hospital Pathology Laboratory need to use “proprietary” processes to test for recombinant DNA in the vaccine? Whenever I see a result like this attributed to proprietary, non-transparent methodology, it sends up huge red flags, particularly when it comes to doing something like detecting DNA contamination. I could do it in my own laboratory using simple polymerase chain reaction (PCR) and then sequencing the DNA sequences (if any) that I managed to amplify up! No need for anything proprietary, other than choosing the PCR primers properly! I could use PCR kits right off the shelf and any of a number of PCR machines, either in my lab or the spiffier, newer machines in other labs. Again, the key is choosing the right primers and working out the right conditions, but none of that is anything particularly difficult, although testing different conditions can turn into the drudgery of trial and error.

Before I get to the significance (or, far more likely, lack of significance) of this finding. Let’s take a look at the methodology. I did a bit of Googling for our Dr. Sin Hang Lee, and it turns out that he has a rather–shall we say–interesting history. It turns out that Dr. Sin Hang Lee is rather well known in the Lyme disease community for having apparently invented a new test for Lyme disease. That may or may not be dubious. What is definitely dubious is that he’s also teamed up with SANE Vax to offer an HPV genotyping test announced on the quackery-promoting NaturalNews.com. This latter link actually suggested to me what Dr. Lee’s “proprietary” methodology might be, as it’s described as “nested PCR with short target DNA sequencing for HPV genotyping.” Going back to look at his Lyme disease DNA test, I find this paper, which also used nested PCR to detect sequences from the Lyme disease spirochete Borrelia burgdorferi.

So what is nested PCR? As readers might recall, PCR is a method to amplify nucleic acid sequences, like those of DNA or RNA. I described it in more detail in the context of explaining how the laboratory Andrew Wakefield used produced so many false positive results. I also described how the greatest power of PCR also leads to the greatest difficulties in its usage, namely its extreme sensitivity. PCR is so sensitive that it’s very, very easy to amplify a contaminant or for the primers to bind to (and thereby amplify) DNA sequences other than the one of interest. This problem goes double (or even quadruple) for nested PCR. The reason is that nested PCR involves using one set of primers to amplify a DNA sequence, and then taking some of the resultant reaction mixture and using a second set of primers that amplifies a smaller sequence within the sequence amplified in the first PCR run. The process is illustrated below. First, here’s routine PCR:

i-2b771ce908cdcfd17c0a348b0076e511-PCR.jpg

And here’s nested PCR:

i-c6eac1e243691b93238b7995321ea691-nested-pcr.gif

The usefulness of nested PCR is two-fold: First, because two different sets of primers are used, specificity is increased and the amplification of contaminants decreased because, although there might be contaminants amplified in the first PCR run, it’s very unlikely that any of the unwanted PCR products so amplified contain binding sites for both of the new primers used in the second PCR run. Second, nested PCR can be very, very sensitive, even more sensitive than “simple” PCR, depending upon the number of amplification cycles used in each PCR step. It’s that sensitivity that allows nested PCR to amplify very tiny amounts of target sequence.

Which brings me to the lack of any detail in this report.

Let’s say, for the moment, that Dr. Lee did everything right and actually did detect a bit of recombinant DNA from the HPV DNA used to make the vaccine still remaining in the 13 vials of vaccine he tested. Does this matter? One factor to consider is how much DNA was present, which was almost certainly very, very little, given that it took nested PCR to detect it. However, we don’t know how much was detected, because nothing on the SANE Vax posts tells us enough to let us know approximately how much was detected. Given that, and given the probably minuscule amount of DNA detected, even assuming these aren’t false positives, there is no justification for statements like this:

In an effort to help her now very sick daughter the mother went to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood. The significance of this finding is that it is highly unusual to find HPV DNA in the blood. HPV, if present in the body, exists in the epithelial (skin and mucosa) membranes. HPV or its DNA, by itself does not survive for any great length of time in the bloodstream. Why was the HPV DNA in her bloodstream two years post-vaccination?

My answer would be: Probably because the naturopath, like most naturopaths, didn’t have a clue what he was doing or how when he “detected” HPV DNA in the blood. If Dr. Lee had clue one, that’s what he would have said. But he didn’t. He said this instead:

According to Dr. Lee, “‘Natural HPV DNA does not remain in the bloodstream for very long. However, the HPV DNA in Gardasil™ is not ‘natural’ DNA. It is a recombinant HPV DNA (rDNA) – genetically engineered – to be inserted into yeast cells for VLP (virus-like-particle) protein production. rDNA is known to behave differently from natural DNA. It may enter a human cell, especially in an inflammatory lesion caused by the effects of the aluminum adjuvant, via poorly understood mechanisms.

“Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.”

This is utter nonsense. First off, as I described before, it’s not a trivial matter to get recombinant DNA into human cells and expressing the protein that its sequence codes for. It’s worth repeating what I described when I first encountered this idiocy in a different context. For rDNA to do what Dr. Lee worries about, the minute amount of rDNA in the HPV vaccine would have to:

  • Find its way into human cells in significant quantities, which is highly unlikely given the tiny amount that, even in the worst case, is there.
  • Express the protein that it codes for, which would require that the DNA be intact, complete with its promoter and regulatory regions. Again, this is incredibly unlikely, given the amount of DNA we’re talking about unlikely.

I actually have some experience with direct intramuscular injection of DNA to try to get gene expression. Indeed, some of the earliest experiments studying gene regulation in rat muscle by direct injection of plasmid DNA were performed in the laboratory where I did my PhD work, and even now I know investigators who are working on DNA vaccines. It takes microgram quantities of intact plasmid DNA, and even then expression levels are low without special help, such as the “gene gun” or other techniques. Also remember that the HPV vaccine is made of non-infectious HPV-like particles, which are basically formed from the L1 surface protein of the HPV virus, which makes the outer coat of the virus particle. Even in the highly unlikely situation that the tiny amount of recombinant DNA alleged to be left behind in Gardasil could get into human cells and actually make detectable amounts of VLP, the only place it’s likely to be able to do that is in the muscle in the immediate vicinity of the injection site.

None of this prevents SANE Vax from laying down some serious extrapolating beyond science and reason:

SANE Vax Inc. wants to know how many adolescents who have suffered adverse reactions post Gardasil vaccination have HPV DNA in their blood. What are the medical ramifications should HPV DNA remain in the bloodstream for an extended period of time?

Does the aluminum adjuvant become the carrier for HPV DNA causing said DNA to remain in the blood and/or organs for an extended length of time?

Since viral DNA cannot replicate by itself (it needs a host cell) what happens if genetically engineered viral DNA enters a human host cell?

In a followup post, SANE Vax demands:

  • What autoimmune-related disorders could result from this contamination?
  • Is it possible for this contamination to initiate gene mutations which may lead to cancer?
  • What genetic changes (mutagenesis) could occur should the residual HPV DNA enter and begin reproducing in a human cell?

All of this is putting the proverbial cart before the horse. First things first. Before anyone takes the claim that there is HPV DNA left in HPV vaccines and, more importantly, before anyone does anything (if, indeed, anything even needs to be done), an external laboratory needs to replicate Dr. Lee’s results. Interestingly, SANE Vax now appears to be backpedaling a bit:

The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory known in using cutting-edge DNA sequencing for molecular diagnoses. This methodology was first reported to the FDA in 2006 and has been published in various peer-reviewed scientific journals, stated Erickson.

Well, well, well, well. If Dr. Lee’s methodology was reported to the FDA in 2006 and has been published in peer-reviewed scientific journals, then what’s “proprietary” about it, and why is he so reluctant just to publish his results regarding the HPV vaccine? I challenge Dr. Lee and SANE Vax to publish in full the complete methodology used to make this finding, along with the results. I find it most ironic that SANE Vax calls on the FDA and Merck to be “transparent,” but nothing about the way SANE Vax has publicized its “results” is in the least bit transparent, nor has Dr. Lee’s methodology to obtain these results been peer-reviewed. Worse, in the SANE Vax letter to the FDA, SANE Vax demands assurances that the FDA will protect Dr. Lee’s proprietary methodology before it will provide the FDA with its results. The hypocrisy and intellectual dishonesty are staggering. More importantly, without SANE Vax’s alleged results being available to the FDA and independent scientists to examine, all we have to support the claim that there is recombinant DNA in the HPV vaccine is the word of an anti-vaccine group.

Color me not particularly worried. Until there is independent verification, it’s utterly pointless even to worry about these other questions because the source, being rabidly anti-HPV vaccine, is suspect, and there is no way to determine if the methodology used is valid and not likely to produce false positives. After all, the HPV vaccine is tested for the presence of recombinant DNA, and it’s below the limit of detection of standard techniques; otherwise, Merck, the FDA, and other scientists would have detected it before. Only a scientist affiliated with an anti-vaccine group can seemingly detect it. Moreover, even if Dr. Lee did detect what previously couldn’t be detected before, clearly he’s detecting rDNA at such a low quantity that it’s doubtful that it would be harmful in the least. Certainly, given such a tiny amount of rDNA, it’s downright silly to talk about whether the aluminum adjuvant could somehow become a “carrier” for HPV DNA that allows it to be present in the blood for an extended period of time. Given that the HPV rDNA couldn’t replicate, the law of conservation of mass is enough to dismiss this concern as ridiculous, because it would take far more DNA than could possibly be in the adjuvant to produce detectable levels in the blood for long periods of time.

Maybe Dr. Lee should be come a homeopath. He seems to think that the more the HPV DNA is diluted, the stronger it becomes.

Comments

  1. #1 peter english
    September 6, 2011

    Even in the unlikely case that there is a significant amount of HPV rDNA in the vaccine…

    It would be extremely unlikely to be incorporated into cells, and expressed, and…

    If it were expressed, it would only express the vaccine antigens…

    And if it were to do this, it would be acting as a DNA vaccine, harmlessly providing the recipient with even better protection. Lucky them!

  2. #2 peter english
    September 6, 2011

    Even in the unlikely case that there is a significant amount of HPV rDNA in the vaccine…

    It would be extremely unlikely to be incorporated into cells, and expressed, and…

    If it were expressed, it would only express the vaccine antigens…

    And if it were to do this, it would be acting as a DNA vaccine, harmlessly providing the recipient with even better protection. Lucky them!

  3. #3 herr doktor bimler
    September 6, 2011

    rDNA is known to behave differently from natural DNA.

    Magic DNA! Homologous Recombinaltion Tiniker!

  4. #4 LW
    September 6, 2011

    “the mother went to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood.”

    Ah, a toxicity test. *Nods wisely*. That would be something like asking the girl to hold a vial of vaccine while the naturopath presses down on her hand?

  5. #5 MikeMa
    September 6, 2011

    Sounds like another load of fear-crazed bollocks. Scary sounding, cringe inducing crap. Even at its worst, I expect cervical cancer sounds worse.

  6. #6 Reuben
    September 6, 2011

    I’m going to do what antivaxers do and accuse them of a conspiracy. The conspiracy is thus: Rick Perry is running for president. Rick Perry has to back away from science and reason in order to appeal to the base of Republicans that believe the Earth is young, among other stupidities. Rick Perry backpeddaled on his decision to mandate the HPV vaccine. Thus, by aiming all their antivaccine efforts at the HPV vaccine, the antivaccine loons are attempting to make this an election issue. It wouldn’t surprise me if they plant someone at political events to bring their hate and discontent for science to the forefront. Heck, why go that far? They just have to get Perry on Oprah or some such television show. (Oprah’s not on anymore, I know.)

  7. #7 Peter Bowditch
    September 6, 2011

    Thanks for the HT.

    In the article about how they had contacted the FDA they didn’t name the testing laboratory. I received much adverse commentary for asking for the name of the lab. Apparently this is too hard a question to answer and I shouldn’t have been asking in the first place as it is private information. Telling them the name of the laboratory that did my last diabetes check went whooshing over the points on their heads.

    I have now been told that asking for the necessary and effective vaccines implied in the “N” and “E” of the name SANE is a dishonest question.

    In all this, the people who actually run SANE have been invisible. It seems that they are prepared to leave all discussion to their fans. I believe the words “plausible deniability” could have relevance here.

    I have emailed the SANE people directly with a request for clarification of the necessary and effective vaccines, but I don’t expect a coherent answer. Or any answer at all, in fact.

  8. #8 Bec
    September 6, 2011

    oh the horror, the horror!!! i hope said lab does not look too close and see….of all things….*gasp*…Water for injection too! FFS!

  9. #9 gr8blessings
    September 6, 2011

    In between these fear-mongering posts, SANEvax is now promoting their genotype testing for a mere $50/test.

    http://sanevax.org/post-hpv-vaccination-tests/

    What a great scam. Create fear and false validity to your testing method and then play on that fear to get folks to give you $50. Sometimes I wish I was as dishonest so that I could profit off the gullibility of others like these scam artists do.

  10. #10 Julian Frost
    September 6, 2011

    [T]he mother went to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood.

    Stupid question: just how does a “toxicity test” (whatever THAT is) detect DNA? Also, given that viruses consist of RNA (not DNA), how do you get HPV DNA in the first place?

  11. #11 herr doktor bimler
    September 6, 2011

    Create fear and false validity to your testing method and then play on that fear to get folks to give you $50.

    A cutting-edge test that has so far produced 100% positive results from every sample SANE-Vax sent them. There does seem to be a business model emerging here.

  12. #12 palindrom
    September 6, 2011

    On this “test” — it’s one thing to offer worthless cures, which is apparently protected thanks to Sen. Harkin, but — is it another thing, legally, to offer fraudulent “tests”?

  13. #13 Clare
    September 6, 2011

    @10

    HPV is actually a double stranded DNA virus (theres quite a few DNA viruses like variola, the cause of smallpox) so at least on this one point they are kind of correct.

    I would be interested to see the controls they used and the primer sequences, PCR is quite easy to contaminate and unless they have a good positive and negative control this means nothing.

  14. #14 Dangerous Bacon
    September 6, 2011

    It’s interesting that Dr. Lee’s company has issued a press release calling for the FDA to document its statements about the role of low-risk HPV types in vulvar and vaginal cancer, while at the same time we can’t know about how he did his testing because it’s “proprietary”.

    It’d be very interesting to know what controls Dr. Lee might have used, if that’s not “proprietary” information, and what controls the naturopath/M.D. used in testing for “toxic” HPV DNA in the patient’s blood.

    Dr. Lee seems poised to be the antivax movement and NaturalNews’ go-to pathologist.

    “He is very concerned as we all are, that the duration of the HPV vaccines have not yet been established, agreeing with the issues raised time and time again by Dr Diane Harper. He says that since Gardasil injections can increase the risk of developing precancerous lesions by 44.6% if there is a prior infection by a vaccine-relevant HPV genotype (oh really?), and that it is prudent to make sure that a sexually active woman is not infected by HPV 16, 18, 31 or 45 before receiving a Gardasil vaccination. This is why along with SANE VAX he will be offering the chance of safe HPV testing before vaccination.

    Dr. Lee is said to be ecstatic that HPV testing will be at last on offer and is working alongside the SANE VAX organisation, in offering discounted rates to those women interested.”

    I don’t doubt he’s “ecstatic”, but the news release makes it sound like Dr. Lee is a pioneer in HPV testing and that only now will women be able to get it, when in fact HPV testing has been available for years (going back to 2003).

  15. #15 Orac
    September 6, 2011

    Maybe if I can find the exact methodology used, I’ll be able to play around with BLAST and some of the PCR tools I have access to, online and otherwise, to see if the methodology can even potentially do what is claimed for it. Dr. Lee sure doesn’t make it easy, though.

  16. #16 Science Mom
    September 6, 2011

    One of the citations here: http://www.cankercillin.com/dr__sin_hang_lee.htm may give you what you are looking for.

  17. #17 Dangerous Bacon
    September 6, 2011

    I see that Dr. Lee’s company has issued a press release calling for the FDA to document its statements about the role of low-risk HPV types in vulvar and vaginal cancer, while at the same time we can’t know about how he did his testing because it’s “proprietary”.

    It’d be very interesting to know what controls Dr. Lee might have used, if that’s not “proprietary” information, and what controls the naturopath/M.D. used in testing for “toxic” HPV DNA in the patient’s blood.

    Dr. Lee seems poised to be the antivax movement and NaturalNews’ go-to pathologist.

    htp://www.weeklyblitz.net/949/dr-sin-hang-lee-joins-forces-with-sane-vax-inc-in (link broken)

    “He is very concerned as we all are, that the duration of the HPV vaccines have not yet been established, agreeing with the issues raised time and time again by Dr Diane Harper. He says that since Gardasil injections can increase the risk of developing precancerous lesions by 44.6% if there is a prior infection by a vaccine-relevant HPV genotype (oh really?), and that it is prudent to make sure that a sexually active woman is not infected by HPV 16, 18, 31 or 45 before receiving a Gardasil vaccination. This is why along with SANE VAX he will be offering the chance of safe HPV testing before vaccination.

    Dr. Lee is said to be ecstatic that HPV testing will be at last on offer and is working alongside the SANE VAX organisation, in offering discounted rates to those women interested.”

    I don’t doubt he’s “ecstatic”, but the news release makes it sound like Dr. Lee is a pioneer in HPV testing and that only now will women be able to get it, when in fact HPV testing has been available for years (going back to 2003).

  18. #18 Poodle Stomper
    September 6, 2011

    Julian,
    “Stupid question: just how does a “toxicity test” (whatever THAT is) detect DNA? Also, given that viruses consist of RNA (not DNA), how do you get HPV DNA in the first place?”

    Viruses can be DNA based. Some are and some aren’t. HPV is a DNA virus (if I recall correctly). In this case, however, the claim is that they are detecting the recombinant DNA used to generate the vaccine. This is even sillier as the odds are that the rDNA consists only of the outer portion of the virus and does not include all the other genes necessary for the virus to replicate. In short, their claim is a stupid pie with stupid filling topped with a stupid cherry.

  19. #19 MikeMa
    September 6, 2011

    @Poodle Stomper,
    That filling is stupid people’s money. Its like a horror film. They are paying to scare themselves witless.

  20. #20 Th1Th2
    September 6, 2011

    Poopoo Stomper,

    This is even sillier as the odds are that the rDNA consists only of the outer portion of the virus and does not include all the other genes necessary for the virus to replicate. In short, their claim is a stupid pie with stupid filling topped with a stupid cherry.

    Oh I see what the problem is. HPV vaccine is a “stupid pie with stupid filling topped with a stupid cherry.”

  21. #21 qetzal
    September 6, 2011

    [Dr. Lee] says that since Gardasil injections can increase the risk of developing precancerous lesions by 44.6% if there is a prior infection by a vaccine-relevant HPV genotype.

    He makes the same claim in the intro to this paper, referencing one of the FDA reveiw documents for the vaccine. And it’s true that there was one subgroup of one clinical study that showed 44.6% greater incidence of cervical intraepithelial neoplasia grade (CIN) 2/3 in women who were PCR positive and seropositive for relevant HPV strains at the time of vaccination.

    However, Dr. Lee neglects to mention a few relevant facts.

    > This was a subgroup analysis from a single study.
    > The difference was not statistically significant.
    > The subgroups weren’t well balanced, with the subgroup who were HPV positive and received the vaccine having more risk factors than the subgroup who were HPV positive and received placebo.
    > The same subgroup analysis in a different clinical study showed less CIN2/3 in the vaccinated group (the opposite of the number that Dr. Lee cherry-picks).
    > When the same subgroups were combined across three different trials, there was net tendency for the vaccinitated subgroup to have more CIN2/3 than the placebo group, but the difference was only 12% and was not statistically significant.

    IOW, Lee’s comments are quite biased and tantamount to lying by omission.

    You can read the FDA analysis for yourself here, starting on page 13.

  22. #22 exarch
    September 6, 2011

    I wonder if someone who’s never had the HPV vaccine would also test “positive” for HPV-DNA in their blood?

  23. #23 Denice Walter
    September 6, 2011

    Oh, the words don’t have any meaning, I think that they just threw them in so as to have an easily pronounceable acronym.

    There’s an incredibly bad book,”Fear of the Invisible”**, the title of which neatly sums up the attitude and motivation of the anti-vaccination movement.

    Fear mongerers take advantage of the frightened public who are overwhelmed by incredibly complex systems they don’t understand which are composed of minute and nearly unobservable inter-related parts- whether we’re discussing human physiology or the markets- and research surrounding the issues is equally opague and inacessable . A salesman will step in, and peddling his (her) own “expertise”, will re-assuringly “explain” how the system works in simple terms for the “layman” ( as the mark is ironically labelled by the woo-meister). Complexity and invisibility are counter-acted by their powerful “educational” device: it’s called “lying”, although it may also reflect their own impoverished conceptualisations and thus be revelatory to us; I believe that you can estimate a woo-meister’s amount of real education in his speciality based on his “theory”.

    It’s very interesting how alt med “explanations” for complex situations tend to be attributable to single causes: toxins, lack of anti-oxidants***,or omnivorism. Yet they call SBM “reductionalism”!( Similarly, we’re hearing many econ-woos saying that “Gold is the answer”) Then they sell you similarly simplistic “cures”- chelation, supplements, or a book on veganism ( or gold.)

    When people have little information, their own fears can get the best of them: this human tendency is the capital that woo-meisters build their fortunes upon, gathering interest and dividends over time. They ramp up fear about health issues or whatever else they’re selling. Then offer the “solution”.

    Of course, no fearmongering effort would be complete without frightening enemies: that’s SBM and its supporters. Gardisil is ideal because it adds another factor to the fear factory: sexuality of (gasp!) girls. So it’s not just fear of evil poisons being injected. SBM enters the garden of purity armed with the apple- like the Serpent- from the tree of knowedge of good and evil. Can’t have that now, can we?

    **by Janine Roberts and deeply beloved by anti-vaxxers and HIV/AIDS denialists. Quick summary: fear the monkey-contaminanted vaccines! Don’t fear HIV!

    *** low ORAC

  24. #24 Poodle Stomper
    September 6, 2011

    Must not feed thingie troll. Stupid trolls that don’t understand the first thing about biology are a waste of time.

    @exarch,
    That’s the million dollar question, isn’t it? Do their super-secret proprietary methods have a high level of false positives A la WPI-XMRV? My guess is yes. I would be willing to bet that it’s either a complete crock or a very poorly designed test with high false positive rate. Maybe both.

  25. #25 Jud
    September 6, 2011

    homologous recombination of fetal DNA in vaccines

    Don’t know why I at first misread this as “humongous contamination of fetal DNA in vaccines.” Must be ’cause Lee’s stuff was so sciencey and all.

  26. #26 Chris
    September 6, 2011

    SANEVax is one flaky website. I clicked on the “About” yesterday and got a “404 page not found” error, today it worked fine. Except from their “About” page when I clicked on “Vaccine Groups” I got the “404 page not found” error, but it was fine from the drop down menu.

    Anyway, their list of “vaccine groups” at http://sanevax.org/resources/vaccine-groups/ includes: NVIC, Australian Vaccination Network, Alan Phillips (the writer of the very common “Vaccination Myths”, which a list of lies), Vaccine Injury Help Center (which are a bunch of lawyers), ThinkTwice, Age of Autism, Generation Rescue and a few obscure anti-vax groups. One of them is “Truth about Gardisil”, but I doubt it considering the company they keep.

  27. #27 Roadstergal
    September 6, 2011

    I wonder if someone who’s never had the HPV vaccine would also test “positive” for HPV-DNA in their blood?

    That is one of the negative controls that needs to be run (as alluded above, the specificity of PCR can be ‘tweaked’ by reaction conditions to be more or less stringent). Another is the control of all of the reaction materials, but with water as template instead of DNA (to control for primer amplification and/or DNA contamiation of reagents/bench/pipettes/etc.). Without controls, PCR tells you nothing.

  28. #28 brian
    September 6, 2011

    The only HPV DNA that could be included in the vaccine is that for the open reading frame of L1 (the major outer capsid protein) which has been subcloned via PCR and then replicated in yeast. If a tiny fraction of the DNA from that single HPV gene (for a protein product that is, by itself, noninfectious and of course nonpathogenic) somehow squeaks through the process by which the L1 protein is extensively purified, it might make a dandy DNA-based vaccine, along these lines:

    http://www.snupharm.ac.kr/ohyk/erp/erpmenus/professor_thesis/upLoadFiles/2009_vaccine_viral%20Vaccine.pdf

    So, the downside of having a bit of a single gene of noninfectious HPV should be, at worst, to produce a somewhat more effective vaccine, although it seems that it could sound scary to those who don’t understand.

  29. #29 Poodle Stomper
    September 6, 2011

    “So, the downside of having a bit of a single gene of noninfectious HPV should be, at worst, to produce a somewhat more effective vaccine, although it seems that it could sound scary to those who don’t understand.”

    Which is unfortunately exactly who they are targeting. It makes my science cry.

  30. #30 laura
    September 6, 2011

    @orac @brian and others

    Thank you all for the science presented in response to the Sane Vax post on
    Gardasil.

  31. #31 augustine
    September 6, 2011

    http://www.immunisation.org.nz/hpvtraining/appendix/D/Gardasil-Data-Sheet-July08.pdf

    GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique
    recombinant L1 major capsid protein for the respective HPV type. Because the virus-like
    particles contain no viral DNA, they cannot infect cells or reproduce.

    Sounds like Merck has some technological issues with their vaccines or they are lying.

    Is ORAC saying that Merck lying is OK because “what’s a little DNA injected with adjuvants going to harm?”

  32. #32 augustine
    September 6, 2011

    @26 Chris,

    Critical thinkers will recognize this entire post #26 as an ad hominem attack

    “one flaky website”, “list of lies”, “bunch of lawyers”,”obscure”, and “company that they keep”.

  33. #33 sylph
    September 6, 2011

    @Brian

    Well, presumably they amplified L1 from an intact HPV genome, right? It’s like homeopathy, see? You dilute the intact genome by amplifying a small portion of it, cloning it, then putting it into yeast, then extracting the protein from the yeast, then injecting it into someone, then allowing it to (somehow) transfect cells. A 30C dilution in homeopathy has nothing on this.

    (We’re going to ignore the fact that HPV is not something simple like HCV or polio, and without the viral proteins, the DNA is basically just going to sit there)

  34. #34 CG
    September 6, 2011

    There’s yet another problem involved.

    The DNA would have to get into a cell (extremely unlikely), get into the nucleus (even less likely), insert into the genome (downright impossible), and worst of all, it needs to pick up a working promoter in the process.

    The capsid was cloned into yeast. It has a yeast promoter, which won’t work in humans. I would wager the gene would never express anything in anyone.

  35. #35 herr doktor bimler
    September 6, 2011

    is it another thing, legally, to offer fraudulent “tests”?

    How is the test fraudulent? It does exactly what it’s designed to do. It detects HPV DNA… every single time.

    It does sound as if someone saw the money to be made from selling bogus XMRV tests, decided they wanted a slice of the pie, and set up a “vaccine safety” front organisation.

  36. #36 lilady
    September 6, 2011

    Has anyone mentioned this? I found that Dr. Sen Hang Lee also own HiFi DNA…available at HiFiDNA.com in a nearby town in Connecticut.

    Dr. Lee has also filed a lawsuit against the FDA apparently for licensing of a new HPV pathology test:

    HiFiDNA Tech files lawsuit against FDA (October 15, 2007)

    The “watchdog” group Judicial Watch has also been quite busy investigating the many VAERS reports and issuing press releases about their “findings”:

    Judicial Watch Investigates Side-Effects of HPV Vaccine

  37. #37 Mu
    September 6, 2011

    Makes you wonder if a positive test comes with the address of a group of lawyers specialized in helping the “patient” to deal with the vaccine injury court. Anyone got $50 to spare?

  38. #38 AnneS
    September 6, 2011

    The recombinant DNA is clearly to blame for the the fact that Gardisil injections hurt like a bitch.

    (I still joyfully received all three of them, all the while telling myself that cervical cancer would end up hurting a lot more. Much worse than a flu shot for me, though.)

  39. #39 laura
    September 6, 2011
  40. #40 Matthew Cline
    September 6, 2011

    If the proprietary part of their test is the choice of PCR primers, I could see why they’d want to keep it a trade secret, since it probably wouldn’t be worth it to get a patent, but if they released the information other companies willing to prey on the fears of parents could duplicate their test. However, if it uses the “cutting-edge DNA sequencing” that they attribute to Dr. Sin Hang Lee, then it really makes no sense for them to keep it a trade secret rather than getting a patent, since by getting a patent they could license the technique to other companies and rake in lots of money.

  41. #41 Jarred C
    September 6, 2011

    @exarch #22

    I wonder if someone who’s never had the HPV vaccine would also test “positive” for HPV-DNA in their blood?

    Or, perhaps the effect isn’t his technique, but himself. The positives come from people who he thinks have had the vaccine, and the negatives from people who he thinks haven’t. So we send him some samples from people who haven’t had the vaccine, but tell him they have, and some samples from people who’ve had the vaccine, but tell him they haven’t.

  42. #42 Poodle Stomper
    September 6, 2011

    @Jarred C,
    …or send him multiple samples from the same person with varying background stories and see what happens.

    @CG,
    “The capsid was cloned into yeast. It has a yeast promoter, which won’t work in humans. I would wager the gene would never express anything in anyone.”

    That actually depend on which promoter they are using. As eukaryotes, yeasts can use some promoters that our cells use and vice versa. Now I don’t know which promoter they used (so I can’t say for sure) but if they used a highly active one such as a CMV-derived promoter, our cells could use it to drive expression.

  43. #43 brian
    September 6, 2011

    Poodle Stomper, FWIW I believe that Merck used the pGAL110 yeast expression vector which contains the GAL1-GAL10 promoter.

    Even if some L1 could be produced by transcription from the yeast promoter using the minute amount of DNA that would pass the purification steps of vaccine production, why the possible production of a small amount of a single, nonpathogenic viral protein which would enhance immunity to HPV would be a problem is still unclear to me. Do the people who raised this issue understand nothing at all of virology?

  44. #44 Anonymous
    September 6, 2011

    Trust me, Orac, take some time to chill and work on your yard a bit. I’m laying off on the info bombardment and it seems a healthy thing. Brains need rest and this is not meant to be facetious.

  45. #45 Poodle Stomper
    September 6, 2011

    Brian,
    It looks like you are correct. Indeed, it would be unlikely then, that the promoter would drive expression in our cells even in the unlikely event that it would be taken up intact. Thanks for the info!

  46. #46 qetzal
    September 6, 2011

    Brian,

    No, the people who raised this issue do not understand virology, or much of anything else. They have no interest in understanding. They’ve bought into the nonsense idea that recombinant DNA is somehow unnatural and will turn their babies into cancerous mutants. They’re not about to let any inconvenient science get in the way of their grand conspiracy theories.

    It’s actually rather sad.

  47. #47 qetzal
    September 6, 2011

    P.S. Whoever wrote that press release from Lee’s company HiFi DNA is a bit of a moron. They most certainly did NOT file a lawsuit against the FDA. They filed a petition to have their method for detecting HPV by nested PCR reclassified as a Class II device.

    Buncha maroons, if you ask me.

  48. #48 Denice Walter
    September 6, 2011

    @ qetzal:

    Exactly! I am trying to get my head around the fact that some alt med folk can simultaneously:
    be afraid of vaccines *and*
    not be afraid of HIV!
    this bizarre inversion of realistic risk appraisal may of course be due to the higher order pseudo-scientific dictum of germ denialism: you don’t need vaccines because micro-organisms/ virii can’t harm you
    and HIV – a virus- is harmless as well!
    Whew! That last sentence is so outlandish that I had trouble typing it!

  49. #49 JJ
    September 6, 2011

    I’ve no particular feeling for SaneVax, Rick Perry, Gardasil, etc. but it’s quite amusing watching ‘scientists’ being all sneery about alternative medicine and anyone who doesn’t make the appropriate obeissance to the superior wisdom of Western medicine.

    Having just been told by my doctor that we have to get me off Advair because, oops, it’s black box warning time, when a few years back he treated me like an idiot for being reluctant to go ON Advair, I can’t help but laugh. Science is all just lovely until it’s…well, wrong. Incomplete. Well, you see, we didn’t know then that…fill in the blank.

  50. #50 Chris
    September 6, 2011

    JJ, define “Western medicine.” If your medication had been developed in Japan, like the DTaP vaccine, does that make it okay? Do you condemn homeopathy because it was invented in Germany, as opposed to it being incredibly silly? Tell us exactly what makes it “Western.”

    Oh, and just because one medication does not work for you, that is not evidence that “alternative” medicine works. What shows something works is actual evidence it works.

    And due to the fact humans are complicated, some people have reactions to certain drugs that are lifesavers for others. I, for example, am part of the 10% of the population cannot tolerate narcotics, they literally make me vomit. This meant that when I fell last winter and bruised my ribs my only option was ibuprofen. The Emergency Dept. doctor could only give me assurances that the bruised ribs do hurt more than broken ribs (which I have had) due to inflammation, something that would be helped by ibuprofen.

    Okay, Advair does not work for you, but there are probably many more people that it perfectly fine.

  51. #51 sylph
    September 6, 2011

    As to all the promoter talk… I cloned this one fluorescent protein (and other not so important things) into pBluescript, something with a bacterial and no mammalian promoters. I subcloned it, or thought I did, into a plasmid with a mammalian promoter. I put the plasmid into HEK293T cells, and saw a little bit of fluorescence. This is unusual for HEK293T – they’re protein factories; if they’re making a fluorescent protein, it should be blinding you on the microscope. So I sequenced the plasmid… still pBluescript, still bacterial promoter. Even though the machinery was all wrong, and I mean 3 billion years of evolution wrong, the HEK293T cells still made my fluorescent protein. Life is weird.

  52. #52 qetzal
    September 6, 2011

    JJ:

    Science is all just lovely until it’s…well, wrong. Incomplete.

    Yep. Incomplete – like claiming that Gardisil is contaminated with HPV DNA based on incomplete and uncontrolled studies. And wrong – like claiming that recombinant DNA is somehow magically different than “natural” DNA.

    Science isn’t perfect, so these bozos deserve to be taken seriously? No.

  53. #53 CG
    September 6, 2011

    They apparently used a Gal promoter to express L1.

    It might give a little expression for the protein in mammalian cells, but it wouldn’t be very active.

  54. #54 W. Kevin Vicklund
    September 7, 2011

    It should be noted that the black box warning for Advair was issued back in 2006. JJ’s story seems to be a little fishy.

  55. #55 lilady
    September 7, 2011

    Merck developed and manufactured the first rDNA vaccine against Hepatitis B twenty five years ago. Recombivax vaccine is manufactured using a non-infectious sub unit of the virus gene coding for HBsAg then cloned into yeast.

    There hasn’t ever been any report of this vaccine causing an infection in the hundreds of millions of people immunized with the 3-dose series and the tens of millions of immunized people who have occupational risk and were tested for post-vaccine immunity.

    And…Dr. Lee tested how many individuals with his “secret” PCR serum test?

  56. #56 Matthew Cline
    September 7, 2011

    @augustine:

    Sounds like Merck has some technological issues with their vaccines or they are lying.

    Assuming (for the sake of the argument) that the test by Dr. Lee is accurate, the test only indicates that the DNA is somewhere inside the vaccine, not necessarily that the DNA is contained in the virus-like particles.

  57. #57 ken
    September 7, 2011

    URGENT ALERT FROM THE CDC

    BE PREPARED FOR THE COMING…………

    http://emergency.cdc.gov/socialmedia/zombies_blog.asp

  58. #58 Chris
    September 7, 2011

    Um, Ken… the CDC zombie attack page was a tongue in cheek way to remind people to be prepared. Ir has been out for months.

    This is the second time you posted the link. Are you for or against preparing for earthquakes, hurricanes and other natural disasters?

  59. #59 herr doktor bimler
    September 7, 2011

    Makes you wonder if a positive test comes with the address of a group of lawyers specialized in helping the “patient” to deal with the vaccine injury court.

    I’m thinking that the real money is to be made in *treating* the rDNA infection only Dr Sin Hang Lee can detect, and its various manifestations.

    Apparently juvenile-onset acute rheumatoid arthritis is one of these manifestations. What other conditions normally show up at the right age for SANE-Vax to blame them on Gardasil? Is juvenile-onset epilepsy covered in their website?

  60. #60 herr doktor bimler
    September 7, 2011

    Is ORAC saying that Merck lying is OK because “what’s a little DNA injected with adjuvants going to harm?”

    Reading comprehension. It really isn’t that difficult. A Dr. Sin Hang Lee has used error-prone methods to make an unverified claim that DNA is present (and that Merck is lying), but the title of the post conveys a subtle hint of skepticism about the accuracy of that claim.

    The title of the post is up there at the top of the page, if you don’t have time to read the actual post to see what Orac has actually said.

  61. #61 lilady
    September 7, 2011

    @ herr doktor bimler:

    “Apparently juvenile-onset acute rheumatoid arthritis is one of these manifestations. What other conditions normally show up at the right age for SANE-Vax to blame them on Gardasil? Is juvenile-onset epilepsy covered in their website?

    If you visit JudicialWatch.org (“Judicial Watch investigates side-effects of HPV”) you will see the actual VAERS reports under “Documents Uncovered”. They did line runs under a FOIL request and I see a 12 year old with abrupt onset of JRA after 1 shot of HPV vaccine and a report from “a lawyer” whose client who had onset of epilepsy who has “suffered pain, emotional distress and economic loss”, following administration of HPV vaccine.

  62. #62 Matthew Cline
    September 7, 2011

    This sample tested positive for recombinant HPV-11 and HPV-18 residues, both of which were firmly attached to the aluminum adjuvant.

    Wait, how would they have determined that? Did they first separate out the adjuvant from the rest of the vaccine, then test both samples for the DNA? If so, why would they do that before testing for the DNA? If not, what sort of DNA testing would also reveal what was bound to the DNA?

    Also, if the aluminum adjuvant was “firmly attached” to the DNA, wouldn’t that have prevented the DNA from being expressed, rendering it incapable of doing anything?

  63. #63 Catherina
    September 7, 2011

    Chris – well spotted: Germany is totally in the “West”, i.e. West of China and India, the lands of Tradional Wedical Wisdom (TM), so Homeopathy is “Western Medicine” ergo has to be condemned!

  64. #64 Catherina
    September 7, 2011

    “Traditional Medical”, obviously… needs coffee…

  65. #65 Brian Walsh
    September 7, 2011

    I just went to the SANE Vax Facebook site and found this comment near the top:

    “A friend of mine was vaccinated against her will yesterday, as she was about to leave the hospital with her newborn… Now she is afraid to breastfeed and pass the mercury of the shots to her daughter… Any thoughts on this?!! It was a flu and pertussis shot!!! And they also gave the vitamin K to her daughter…”

    I think the thing that pisses me off the most about the anti-vaxxers is the fear thew spread. They are taking what are probably good people who want to do the right thing and twistem them up with so much dread that they can barely cope with the world. It’s just sickening.

  66. #66 herr doktor bimler
    September 7, 2011

    A friend of mine was vaccinated against her will yesterday
    Did they tie her down? Shoot her with a poisoned dart through a blowgun? Inquiring minds are inquiring.

  67. #67 Denice Walter
    September 7, 2011

    @ herr doktor bimler;

    No no no! Several jack-booted ruffians, dressed in black uniforms, kicked her door in and held her down while a drug-crazed doctor violated her purity of essence by insem… I mean *injecting* her with mercury-contaminated pharmaceutical poisons.

    I may have what it takes to be a “citizen journalist” @ NaturalNews.

  68. #68 Vasha
    September 7, 2011

    My guess is that they told her in no uncertain terms that she was behaving irresponsibly toward her baby if she didn’t get vaccinated for pertussis. I don’t think they could (legally or ethically) threaten prosecution for child abuse, but she may have heard such a threat implied, and thus got the vaccine unwillingly.

  69. #69 MikeMa
    September 7, 2011

    I say we issue flags for vaccinated homes. Fly those flags proudly. Let others know your kids are (reasonably) safe to interact with. Make it a sign of honor to fly that vaccinated flag. We can also issue lapel pins for fully vaccinated parents. For those with unvaccinatable folk in the house, you get a flag with yellow edging to let folks know that a vulnerable person lives within.

    No flag equal potential disease vector. Isolation required.

  70. #70 TBruce
    September 7, 2011

    What other conditions normally show up at the right age for SANE-Vax to blame them on Gardasil?

    Acne.
    Morning somnolence.
    Uncontrollable appetite.
    Attitude.

  71. #71 Poodle Stomper
    September 7, 2011

    sylph,
    “As to all the promoter talk…Even though the machinery was all wrong, and I mean 3 billion years of evolution wrong, the HEK293T cells still made my fluorescent protein. Life is weird.”

    Nice. I’ve never had that happen but it’s cool. Isn’t science fascinating?

  72. #72 Dangerous Bacon
    September 7, 2011

    “Several jack-booted ruffians, dressed in black uniforms, kicked her door in and held her down while a drug-crazed doctor violated her purity of essence by insem… I mean *injecting* her with mercury-contaminated pharmaceutical poisons.”

    …directly into her bloodstream!

    The real risk of Gardasil now becomes clear. Recombinant HPV DNA, altered by godless Pharma manipulation, circulates indefinitely in the bloodstream, entering the recipient’s cells at will and inserting itself into host DNA, with the result that one day the unwitting vaccinee wakes up and finds her/himself metamorphosed, Kafka-like into a Giant Genital Wart.

    It could happen.

  73. #73 Calli Arcale
    September 7, 2011

    TBruce — oh my god. You’ve found the true horror. HPV causes . . . PUBERTY!!!!

  74. #74 JJ
    September 7, 2011

    @Chris: Seriously? You can’t define Western medicine as opposed to traditional, alternative, complementary or Ayurvedic medicine or TCM? Uh huh. How was the Scotch?

  75. #75 Hannah
    September 7, 2011

    Being a teenager lots of these comments went a bit over my head, but I got most of the article. I got the Gardasil shot when I was 17, I’m 19 now, and I cannot believe the ant-vaccine people are against Gardasil. I’m pretty sure cervical cancer is the biggest cancer killer women face, and it certainly crops up in young women often. Don’t they have any shame? It’s sickening to me that they would scare parents away from what is basically a cancer vaccine. Ugh.

  76. #76 Todd W.
    September 7, 2011

    @JJ

    You’re the one who brought up the “Western Medicine” term. So, what do you mean by it? What is “Western” medicine, as you define it?

  77. #77 Dangerous Bacon
    September 7, 2011

    Hannah – cervical cancer ranks well behind much more common malignancies (i.e. breast, lung and colon) in fatal cases among women.

    The anti-Gardasil crowd likes to emphasize the relatively few deaths from cervical cancer in women in the U.S., while overlooking the pain, morbidity and/or expense of tracking and treating the much more common atypias and dysplasias caused by the human papillomavirus, which can be prevented by the HPV vaccine.

  78. #78 JJ
    September 7, 2011

    @ W. Kevin Vicklund, Chris and Catherina:

    Yes, apparently the black box warning was issued in 2006, which is why I was all the more concerned that my doctor (a highly respected internist) had not seen fit to say a word about it at my annual exams but had kept prescribing it until a furher warning came out that Advair should be used only for the shortest time possible–which is when he mentioned that perhaps I’d been on it rather a long time and oops, all those symptoms we’d been ascribing to XYZ were actually side effects of Advair.

    I’m a busy person–what with building a business and raising a family, I’ve never had the time to second-guess the people who are supposed to know stuff and advise me, to wit, my doctors. That trust went out of the window with my Advair prescription. I decided to try a Chinese Medical doctor/acupuncturist, who said, “Have you ever been tested for a wheat allergy?” Um, no. So he told me to get tested, do an elimination diet, and come back only once the dust had settled IF I felt I still needed help.

    Turns out I’m highly allergic to wheat and cane sugar, according to Western (“define Western!”) blood tests. My asthma hasn’t vanished, but it’s vastly improved to the point that now I only need an occasional puff on a rescue inhaler.

    Now who do you think acted more ethically–the six different doctors in different parts of the country who prescribed an assortment of asthma drugs over 30 years while poo-pooing any ideas about root causes; the companies that enthusiastically market the drugs without mentioning in the patient literature, “We don’t know much about this stuff; it looks good on paper and may be good in an emergency, but you should really try XYZ before committing to it;” or the Chinese doctor who actually cared about my health instead of myopically focusing on disease symptoms and his income?

    I only came accross this rather smug little blog because I now don’t particularly trust the medical profession. Told to give my daughter Gardasil, I decided to check it out first, and up you popped. What my research suggests so far is that unlike some other important vaccines, Gardasil is probably unecessary and oversold for the majority of women in the US and may have some unintended consequences. This thread also proved to be a window into a rather arrogant, mean-spirited and unpleasant little world. Good grief.

  79. #79 Mephistopheles O'Brien
    September 7, 2011

    @JJ,
    I believe Chris’s point was that the term “Western Medicine” is imprecise, inaccurate, and quite possibly racist.

  80. #80 JJ
    September 7, 2011

    @ Denice: I assume you mean HPV, not HIV. If you think that Gardasil is going to protect you from HIV you may be in for a bitter disappointment. Do the research.

  81. #81 Edith Prickly
    September 7, 2011

    @JJ – you are obviously new around here. You are being asked to define “western medicine” because it’s a false category. There is scientific medicine, which works no matter where it is practiced in the world. Then there is unscientific medicine, also known as alternative or complementary medicine (the preferred term here is “woo”) which is a hodgepodge of mostly superstition-based practices that have been repeatedly shown not to work, but nonetheless have a hardcore rump of defenders who use the “western medicine doesn’t know everything!” gambit whenever anyone points out that the treatments are at best useless and at worst dangerous.

  82. #82 JJ
    September 7, 2011

    @ Dangerous Bacon: while I appreciate that you corrected Hannah’s marketing-driven belief that cervical cancer is a terrifying killer in the US, you might also want to ammend, “common atypias and dysplasias caused by the human papillomavirus, which can be prevented by the HPV vaccine.”

    “May be prevented” would be more accurate given that Merck’s last figures show an overall reduction of 17-45 percent, not 100 percent.

  83. #83 Chris
    September 7, 2011

    JJ, a wee bit of advice: do not use terms unless you know what they mean and can explain their meaning.

    Since you used the term “Western medicine” I expect you to explain what you mean. Tell us exactly what forms of medicine go under that banner and why they are delimited by geography.

    And to your last statement of “Merck’s last figures show an overall reduction of 17-45 percent, not 100 percent”, back it up with references or it will be assumed you are making it up.

  84. #84 JJ
    September 7, 2011

    @Edith: “There is scientific medicine, which works no matter where it is practiced in the world.” ? Are you claiming 100 percent efficacy for ‘scientific medicine’? Really? And you’re claiming that unlike any alternative medicine–you don’t make distinctions–‘scientific’ medicine is never dangerous?

    It amazes me that you’re so quick to defend a system that kills huge numbers of people each year through drugs, errors, over-treatment etc. while rubbishing other systems–even those that provide the basis for Western drugs. That’s throwing the baby out with the bath water, don’t you think? I’m perfectly happy to accept that Western medicine–which I don’t use as a derogatory term but as a term of simple convenience that less deliberately obtuse people in the medical world use routinely–is often a source of miracles, even though it can also be a source of sickness and death. I’m happy to recognize that there are charlatans and money-grubbers in both Western and alternative/complementary systems. None of it is perfect. Seriously. Get some glasses to fix that myopia.

  85. #85 Chris
    September 7, 2011

    JJ:

    -even those that provide the basis for Western drugs

    So are statins western or eastern, because they were developed in Japan? Make up your mind, or be more precise with your language.

    And remember claiming something is bad does prove something else works. If you have a pet form of treatment you like, say perhaps reiki, then prove it with scientific evidence.

  86. #86 Stu
    September 7, 2011

    other systems–even those that provide the basis for Western drugs

    Some of them did, yes. Those parts of “Eastern” or “alternative” medicine that are proven to work have become “medicine”. What’s left by now is snake oil. Or, pray tell, do you have an example of something that is not?

  87. #87 Todd W.
    September 7, 2011

    @JJ

    You misinterpret Edith’s statements. There is medicine that has been shown to work, which, regardless of being used in the West, East, North or South, works in the same manner and to the same degree, regardless of geography. It encompasses drugs, devices and modalities, again, without regard to geography. Some of these medicines work better than others. Some are safer than others. The point is that geography plays no part in that.

    Opposed to this are those drugs, devices or treatments which either have not yet been shown to work or have been shown not to work.

    There is no such thing as “Western Medicine.”

  88. #88 JJ
    September 7, 2011

    @Chris: http://tasti.wordpress.com/category/gardasil/page/3/
    FT via Pharma Wire. I originally found the figure in a Merck press release which I can’t find right now.

  89. #89 Chris
    September 7, 2011

    JJ, find it on an actual Merck website and explain its significance. Otherwise it is just a random blog.

    Personally I believe it is too early to show effects of preventing a cancer that takes years to develop.

  90. #90 Dangerous Bacon
    September 7, 2011

    I am struck by JJ’s equating scientific medicine with “Western” medicine, as though medicine practiced in other parts of the world is by definition unscientific quackery.

    Rather than looking down on non-“Westerners”, I hope JJ realizes that scientific/evidence-based medicine is respected and practiced widely in other parts of the world. Standards of care continue to improve while useless and dangerous folklore practices are abandoned. I’ll bet there are plenty of non-“Western” practitioners who are shaking their heads at the woo that has infiltrated “integrative oncology” practices in the “West”.

  91. #91 Chris
    September 7, 2011

    Dangerous Bacon, if you look at the map at the bottom of this page you can see plenty of red dots in India, China, Japan, Korea and Southeast Asia. They tend to go blinky when it is night time here, so I am sure many of them are shaking their heads at JJ’s implied racism.

  92. #92 Composer99
    September 7, 2011

    JJ:

    As a thought experiment, try imagining what kind of mortality/morbidity we would be dealing with if the only treatments we had for smallpox, breast cancers, or pre-ecclampsia came from, say, pre-modern Ayurvedic medicine or 18th-century German homeopathy, rather than vaccines, surgery & chemotherapies, and induction/C-sections.

    As another thought experiment, try imagining the bad things that could have come from massive use of Vioxx if the manufacturer and/or regulators had not engaged in careful post-licensure surveillance (supposing that the requirements for major pharmaceuticals were as lax as they are for, say, sCAM supplements).

  93. #93 JJ
    September 7, 2011

    @ Chris:

    Well, there’s none so blind as those that won’t read. The figures clearly came from Merck, not the blogger, so you make your own choice as to what you believe. I really don’t care. You get Gardasil for your kid, I won’t get it for mine. Life is good. I’m betting that neither will get cervical cancer.

    @ Todd etc. Well, let’s see. “The system of disease-based medicine taught in US and other countries at medical schools such as Duke and Johns Hopkins, and which results in the appelation of MD, etc., and which depends heavily on drugs formulated by Merck etc.”

    Or you could just call it Western, as did the doctors at Cleveland Clinic when telling my MIL that the post-cancer radiation-induced damage to her body was irreversible under Western protocols and she should try acupuncture and a vegetarian diet for reducing pain and extending her life. (And note: I’m not saying she shouldn’t have had Western cancer treatment. It extended her life, despite the very serious side effects. I’m merely noting that the Cleveland Clinic doctors don’t waste their time pettifogging.)

    But you have it your way. Pettifog to your hearts’ content. Me, I have work to do, entertaining though this may be.

  94. #94 Chris
    September 7, 2011

    JJ, how do I know the blogger did not edit the words? Really, do you not understand that we have experienced less that truthfulness from those trying to promote anti-science?

  95. #95 JJ
    September 7, 2011

    Oops, shouldn’t have checked that my comment posted (as did not my lengthy comment about Advair, which is held up in approval mode). Too tempting.

    @ Composer: You seem to be under the impression that I revile Western medicine. I don’t. Indeed, I applauded it in one comment for creating miracles. I simply think that there are egregious errors and ommissions, and a surpassing arrogance in some practitioners.

    However, I am laughing hysterically at your comment about Vioxx. Clearly you did not follow the trial in Australia and all the information about how Merck shamelessly tried to surpress negative info until they’d made as much dosh as possible, while marketing unscrupulously. You guys should read more widely.

  96. #96 Denice Walter
    September 7, 2011

    @ JJ: re mine @ 23

    I am speaking generically about anti-vaxxers – Gardasil is a vaccine relevant to HPV not HIV… ( HIV vax are ” in the works”)

    Anti-vaxxers: oppose vaccines ( plural) that protect against both viral and non-viral illnesses. Some also deny germ theory.

    As a superordinate class: many alt med people are germ theory denialists *and* some of them oppose both vaccines and don’t view HIV as causative of AIDS or dangerous in itself ( HIV/AIDS denialism)

    I cannot provide the Venn diagram as my computer doesn’t work that way.

  97. #97 TBruce
    September 7, 2011

    JJ:
    You are misinterpreting the study you have cited. It concludes that Gardasil is associated with a 17-45% rate of reversal of CIN II and II (AKA HSIL), in other words, the severe type of precancerous lesions. The subjects in this study would already be infected by the virus. It’s unclear how much of this reversal is spontaneous and how much is attributable to immune stimulation by Gardasil.

    At any rate, this has little to do with the intent of Gardasil, which is to prevent infection in the “naive” population by the most carcinogenic strains of HPV.

    BTW, I always thought that Western Medicine involved a shot of whiskey and a bullet to bite on.

  98. #98 Todd W.
    September 7, 2011

    @JJ

    Well, let’s see. “The system of disease-based medicine taught in US and other countries at medical schools such as Duke and Johns Hopkins, and which results in the appelation of MD, etc., and which depends heavily on drugs formulated by Merck etc.”

    I’ll assume that the “etc.” means any company that formulates drugs, with drugs defined as any substance that one ingests/injects/inhales or otherwise takes into one’s body for the treatment, mitigation or cure of a disease or condition.

    So, by your definition, homeopathy, Chinese Herbal Medicine, Ayurvedic Medicine may all be “Western” medicine, because they focus on the disease, are taught at medical schools around the world, often alongside reality-based medicine and depend heavily on drugs formulated by companies. I suppose the only thing that saves them from being “Western” is that those who study them to the exclusion of reality-based medicine do not earn an MD.

    Your definition excludes any and all surgery, since that depends on the skills of the surgeon, not on drugs, all medical devices, since they are not drugs and any supposed “energy healing” modality such as reiki or therapeutic touch.

    Frankly, that’s a pretty crappy definition of “Western” medicine, since it makes no meaningful distinction between science-based medicine and the nonsense of which you seem to be a fan.

    As to the doctors at Cleveland Clinic, I would say that they were at best naive.

    As I said, there is medicine (which has been shown to work) and there is not-medicine (which has yet to be shown to work or has been shown not to work). Why use any other definition, particularly one as meaningless as “Western”?

  99. #99 TBruce
    September 7, 2011

    JJ:
    You are misinterpreting the study you have cited. It concludes that Gardasil is associated with a 17-45% rate of reversal of CIN II and II (AKA HSIL), in other words, the severe type of precancerous lesions. The subjects in this study would already be infected by the virus. It’s unclear how much of this reversal is spontaneous and how much is attributable to immune stimulation by Gardasil.

    At any rate, this has little to do with the intent of Gardasil, which is to prevent infection in the “naive” population by the most carcinogenic strains of HPV.

    BTW, I always thought that Western Medicine involved a shot of whiskey and a bullet to bite on.

  100. #100 Chris
    September 7, 2011

    JJ, read what Orac posted today on “integrative oncology.” Also explore this blog on opinions of respected medical facilities adopting unscientific modalities. Actually, read one of the many articles on ScienceBasedMedicine blog on the infiltration of non-science in medicine:
    http://www.sciencebasedmedicine.org/index.php/category/medical-academia/

  101. #101 Edith Prickly
    September 7, 2011

    Are you claiming 100 percent efficacy for ‘scientific medicine’?

    No. Are you claiming 100 percent efficacy for woo?

    Most alternative treatments are simply a waste of people’s time and money, but the risks lie in someone with a serious illness delaying effective treatment because their sCAM provider misdiagnosed it/denies it exists. There is also a real danger of developing health problems from following rigid diets, taking unregulated supplements or having an untrained person doing invasive procedures like colon cleanses.

    If you spend a little time searching the archives here, you can read about numerous examples of people who suffered and often died needlessly because they (or in some cases, a parent) rejected conventional treatment in favour of unproven therapies.

    You also might want to read up on the work of Dr. Edzard Ernst, who spent a over a decade doing rigorous testing of many alternative therapies and found that barely a handful of them had any measurable benefits (TCM and ayurveda did not make the cut, BTW.). He and the science writer Simon Singh published an excellent book called Trick or Treatment that I highly recommend.

    It amazes me that you’re so quick to defend a system that kills huge numbers of people each year through drugs, errors, over-treatment etc. while rubbishing other systems

    Do you have any actual numbers to back that up? and what exactly constitutes “over-treatment”?

    Get some glasses to fix that myopia.

    You’re calling me myopic? Have a look in the mirror.

  102. #102 Stu
    September 7, 2011

    Oooh, the cognitive dissonance is strong in this one:

    “The system of disease-based medicine taught in US and other countries at medical schools such as Duke and Johns Hopkins, and which results in the appelation of MD, etc., and which depends heavily on drugs formulated by Merck etc.”

    vs.

    You seem to be under the impression that I revile Western medicine. I don’t.

    Also:

    the doctors at Cleveland Clinic when telling my MIL that the post-cancer radiation-induced damage to her body was irreversible under Western protocols and she should try acupuncture and a vegetarian diet for reducing pain and extending her life.

    Sounds a lot like “do whatever makes you feel better”.

  103. #103 TBruce
    September 7, 2011

    Just to follow up, here is a quote from the article that JJ has cited:

    Dr Rick Haupt, head of biological clinical research and head of the HPV vaccine program at Merck commented, “We stand behind the clinical results.”

    He said the company demonstrated in the clinical trials, women who were negative to the vaccine HPV types 6, 11, 16, 18, who received Gardasil, the efficacy was virtually 100% against disease endpoints, Haupt said. “Another thing we showed is population analyses. We looked at women who entered the study and we looked at the impact of the vaccine, regardless of their baseline status,” he said.

    The efficacy is high in women who are naïve, and the population efficacy benefit is lower in women who have HPV, he noted.

    Now that you know this, JJ, will you consider changing your mind about Gardasil for your “kid”?

  104. #104 Krebiozen
    September 7, 2011

    There’s a Gardasil pack insert here for those interested. Page 16 of that document records several trials that found Gardasil was between 93.8% and 100% effective at preventing HPV 6, 11, 16, and 18 in those not previously exposed. It was 100% effective at preventing overall cervical and genital disease related to HPV 6, 11, 16, and 18 in this group. Since these types of HPV cause 70% of all cervical cancer, that efficacy is impressive.

    Incidentally, browsing through the side effects in RCTs (page 8) I noticed there were 2 cases of death by drug overdose/suicide in those given Gardasil, but 6 in those given placebo. Similarly there was 1 case of death by gunshot in those given Gardasil, and 3 in those given placebo. I only mention this as in the past similar deaths have been listed among alleged side effects of Gardasil by antivaxxers.

  105. #105 Composer99
    September 7, 2011

    JJ, who caught out Merck in Australia? Was it brave, maverick practitioners of Ayurvedic and other “non-Western” wannabe therapies?

    Insofar as Merck got away with shenanigans with regards to Vioxx in Australia, would you argue that it was because there was too much research or not enough? Was Merck behaving in a manner appropriate to the practice of science-based medicine (which is what this blog promotes) or of sCAM-based pseudomedicine?

    In short, I don’t think you have effectively countered my invitation to consider what medicine would be like if major pharmaceutical companies were held to the abysmally low standards favoured by sCAMsters and anti-vaxxers (such as those campaigning against Gardasil) instead of the standards to which they are held now.

  106. #106 herr doktor bimler
    September 7, 2011

    There is no such thing as “Western Medicine.”

    Now that’s not fair. Traditional Western Medicine is a combination of mercury vapour for the Pox, leeches & phlebotomy for everything else, four-humour theory, and diagnosis by urine colour.

    For some reason people disparage that and prefer the time-honoured Ayurvedic ways of killing patients.

  107. #107 ken
    September 7, 2011

    Anyone know why?

    GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.

    http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html

  108. #108 Antiquated Tory
    September 7, 2011

    Hah! Indeed, Herr Doktor, Mark Twain in “Christian Science” decided, after heaping some of his own Respectful Insolence upon it, that while the Christian Science treatment of disease (denial of its existence) was quite likely to kill some patients, it probably wasn’t more likely to do so than a doctor, and furthermore was the appropriate treatment for most illnesses, which are either self-limiting or imaginary. He also quoted from a medical textbook to show that doctors could talk quite as much bollocks as Christian Scientists. The textbook was on phrenology, so in this case he was absolutely right!
    I’ve also recently read some bio of Erasmus Darwin, who was probably one of the best doctors in England in his day. He clearly killed several of his patients through his enthusiasm for foxglove, and killed or destroyed the lives of several others (including Coleridge) through his enthusiasm for laudanum.
    Of course, the transformation of traditional Western professional medicine into global, (at least somewhat) science-based professional medicine is one of the great successes of the 20th Century. Meanwhile, the traditional medicines remain pretty much what they were in Erasmus Darwin’s day.

  109. #109 JJ
    September 7, 2011

    Oh dear, I do have to apologize. Here’s the article I SHOULD have linked to.

    http://www.fiercebiotech.com/press-releases/studies-gardasil-mercks-cervical-cancer-vaccine-and-hpv-16-vaccine-component-gardasil.

    There it was, neatly tucked into my bookmarks. If you’ll look at the section about the Second Investigational study of 17,622 women naive to 14 HPV types, you’ll see what I was talking about. Seems pretty unambiguous to me. However, I’m sure that either those nasty ‘anti-vaxxers’ have ‘edited’ it or I’m somehow ‘misinterpreting’ it. This is straight out of Merck’s press release, which has aged off their site.

  110. #110 JJ
    September 7, 2011

    And here’s a much better definition of Western medicine than mine since you are having such a hard time with my terminology.

    http://www.macmillandictionary.com/dictionary/british/western-medicine

    “the type of medical treatment that is the most popular in North America and Western European countries, based on the use of drugs and surgery to treat symptoms (=signs of illness). In such countries, other types of medical treatment are called alternative medicine or complementary medicine.”

    I could also say allopathic medicine, but I’m sure you’d go into nitwitfits over that, too. Good lord. Probably refers to Western meds in the definition.

  111. #111 JJ
    September 7, 2011

    @ Composer: No, it was, as implied by the term ‘trial,’ the legal system at the behest of the relatives of those who died after taking Vioxx.

    Some really astonishing internal emails were featured in the trial, not to mention fake medical journals dedicated to selling Vioxx. Dirty deeds indeed.

  112. #112 JJ
    September 7, 2011

    @TBruce: You seem to have entirely missed the part about efficacy being only for vaccine strains….and there are a lot more out there, apparently gaining ground, which is why I used the term ‘overall.’ So no, I’m not reconsidering the Gardasil vaccine for my ‘kid’ (why the scare quotes?) at this point. I MAY reconsider if new evidence comes to light.

    Sorry, but the rest of the bombardment of comments are really too silly and out of context to address. I’ll take the easy way out and wish you all a good evening. May you never have a condition that Western medicine worsens or is ineffective against.

  113. #113 Science Mom
    September 7, 2011

    I could also say allopathic medicine, but I’m sure you’d go into nitwitfits over that, too. Good lord. Probably refers to Western meds in the definition.

    Medicine needs no further distinction, unless you are just being a pejorative dick.

  114. #114 Lawrence
    September 7, 2011

    I vote jerk.

  115. #115 Stu
    September 7, 2011

    May you never have a condition that Western medicine worsens or is ineffective against.

    Name one. Then name the “alternative” or “complimentary” remedy for same that does work.

    Come on JJ, you can do it!

  116. #116 laura
    September 7, 2011

    Bio-ethics and Merck’s Gardasil

    “When the manufacturer of the cervical cancer vaccine announced that it will stop lobbying for mandatory vaccination of schoolgirls, my students reacted with jeers. “So what?” said one, “They’ve already achieved their goals.”

    http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=356

  117. #117 TBruce
    September 7, 2011

    JJ:

    Of course I “missed” the part about Gardasil being effective only against certain strains – because these are the strains associated with a high rate of malignant transformation. The other strains that you’re so worried about cause benign lesions that have much less or no risk of malignant change.
    So why is this an issue?

    BTW, that link you provided in #105 does not provide what you say it provides – unless I have to dig through thousands of pages, which I am not prepared to do.

    Also BTW, those aren’t scare quotes – they’re quote quotes. You did, after all, refer to your child as “kid”.

  118. #118 Chris
    September 7, 2011

    JJ:

    And here’s a much better definition of Western medicine than mine since you are having such a hard time with my terminology.

    So the definition you like is:

    the type of medical treatment that is the most popular in North America and Western European countries, based on the use of drugs and surgery to treat symptoms (=signs of illness). In such countries, other types of medical treatment are called alternative medicine or complementary medicine.

    Wow, that is stupid. So the vaccines invented and used in Japan are okay dokay because they are not “Western”?

    I’ll say it again, be specific with your terminology.

    Again, medicine are treatments that have been proven to work. The rest in not medicine. That includes acupuncture, homeopathy (which was invented in Germany), Tong Ren (which was invented in Boston, MA), Ayurveda, etc, etc.

    Laura, that four year old blog opinion has no scientific standing.

  119. #119 herr doktor bimler
    September 7, 2011

    Here’s the article I SHOULD have linked to.
    http://www.fiercebiotech.com/press-releases/studies-gardasil-mercks-cervical-cancer-vaccine-and-hpv-16-vaccine-component-gardasil.
    There it was, neatly tucked into my bookmarks.

    This does not speak well for your bookmarks, since (as TBruce points out) the link leads only to an unstructured archive of pharmaceutical-industry press releases.

  120. #120 herr doktor bimler
    September 7, 2011

    Here’s the article I SHOULD have linked to.
    [...]
    There it was, neatly tucked into my bookmarks.

    Just to warn other readers — JJ’s link does not lead to any article, but (as TBruce has also discovered) to a huge unstructured archive of pharmaeutical-industry press releases.

  121. #121 W. Kevin Vicklund
    September 7, 2011

    Delete the period at the end of his link…

  122. #123 laura
    September 7, 2011

    From the Cancer Journal-
    ANTICIPATED IMPACT OF HPV VACCINATION
    The reduction of cervical cancer risk by 70% or more becomes a theoretic possibility depending on the number of carcinogenic HPV types eventually included in a future HPV prophylactic vaccine and on the percent of the population vaccinated. However, even under the best of circumstances, it will be many decades before this could become a reality. Vaccinating young girls will not have a substantial impact on cervical cancer rates until they attain the median age of cervical cancer diagnosis, 48 years. http://onlinelibrary.wiley.com/doi/10.3322/canjclin.57.1.7/full

  123. #124 LW
    September 7, 2011

    “based on the use of drugs and surgery to treat symptoms (=signs of illness)”

    Hmm, I thought that was homeopathy.

    Putting that aside, what’s so wrong with treating the symptoms until the patient recovers? Sometimes, as in cholera, that’s basically what the patient needs. Also, isn’t every treatment really a treatment of “signs of illness”? If you didn’t have any signs of illness, however difficult to detect, why would anyone want to treat you? Even if the claim is that your aura is green, indicating illness, and you need aromatherapy to cure your illness and make your aura all pretty and blue again, that’s still treating “signs of illness”.

  124. #125 Lawrence
    September 7, 2011

    Exactly – since most women wouldn’t be diagnosed until their mid-40’s, it’ll be a while until we see a substantial decrease in cervical cancer rates.

    Doesn’t mean vaccinating isn’t necessary – it just means the younger women who do get vaccinated now will have a much better chance of avoiding cervical cancer in the future.

  125. #126 laura
    September 7, 2011

    @lawrence
    notice the word “theoretical”
    How many booster shots?

  126. #127 W. Kevin Vicklund
    September 7, 2011

    notice the word “theoretical”

    Yeah, and? You are aware, aren’t you, that the current vaccine only covers some of the HPV serotypes, right?

  127. #128 TBruce
    September 7, 2011

    Doesn’t mean vaccinating isn’t necessary – it just means the younger women who do get vaccinated now will have a much better chance of avoiding cervical cancer in the future.

    It’s fairly common for young women (in their 20’s) to develop HSIL (what used to be classified as Carcinoma in situ and moderate -to- severe dysplasia). This is the bad lesion caused primarily by the strains of HPV that are prevented by Gardasil. It has a high risk of progression into invasive carcinoma in middle age if untreated or undiagnosed ( although it can happen sooner). Besides this, the treatment itself of HSIL can lead to cervical incompetence which increases the risk of miscarriage and premature birth. With HSIL is also the need for more frequent pelvic exams, pap tests and colposcopies to monitor the lesion for recurrence. These are all good to avoid as well.

  128. #129 lilady
    September 7, 2011

    Is this the same “laura” who cited this junk science press release yesterday with the notation:

    Gardasil Vaccine Safe…NOT!?

    Instead of providing links to an ethics lecture and to a four year old article from the American Cancer Society about long-term consequences of preventing cervical cancer, laura needs to read current recommendations (April 21, 2010), from The American Cancer Society for the use of the HPV vaccine…taking special note that they coincide with the ACIP and the CDC recommendations.

    To work best, the HPV vaccine should be given before the young person has had any type of sexual contact with another person.

    * Routine HPV vaccination is recommended for girls 11 to 12 years old.
    * Girls as young as age 9 can get HPV vaccination.
    * HPV vaccination is also recommended for females 13 to 18 years old who have not started the vaccines, or who have started but not completed the series.
    * At this time there is not enough evidence to recommend for or against vaccinating every 19- to 26-year-old female. A decision about whether a woman aged 19 to 26 years should get the vaccine should be based on an informed discussion between the woman and her health care provider. This discussion should include the likelihood of previous HPV exposure and potential benefit from vaccination. The more sexual partners a woman has had, the less likely the vaccine will be helpful.

    The lack of recommendation for vaccinating the 19 to 26-year old age group is based on the following evidence:

    * In clinical trials, women who averaged 2 to 4 sexual partners before they got vaccinated got less benefit from the vaccine in terms of reducing overall cervical cell changes. (The average number of sexual partners for women 19 to 26 is 3 to 4.)
    * The vaccine has not been tested in women who have had more than 4 sexual partners.
    * It is not known if vaccination is cost-effective in this age group.
    * At this time vaccination is not recommended for women over age 26 or for males of any age. Research is now being done on using Gardasil in older females.

    These vaccines protect against 70% of cervical cancers. But the vaccines don’t protect against all cancer-causing types of HPV, so cervical cancer can happen even in women who have been vaccinated. Vaccinated and unvaccinated women should still to be screened for cervical cell changes with Pap tests and other tests, according to current ACS early detection guidelines.

    I don’t believe laura knows that it is a preventive vaccine for the sexually naive and that young preteens do engage in sexual intercourse and “other” practices and prevents oral and anal cancers caused by the strains of the virus contained in the vaccine.

  129. #130 laura
    September 8, 2011

    U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women

    http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html

  130. #131 lilady
    September 8, 2011

    I guess laura did not read the updated American Cancer Society recommendations that I provided above:

    * At this time vaccination is not recommended for women over age 26 or for males of any age. Research is now being done on using Gardasil in older females.

    Here’s an interesting abstract from the Journal of Adolescent Health about incidence of STDs in children who take an “abstinence pledge”:

    Adolesc Health. 2005 Apr;36(4):271-8.
    After the promise: the STD consequences of adolescent virginity pledges.
    Brückner H, Bearman P.
    Source

    Department of Sociology, Center for Research on Inequalities and the Life Course, Yale University, P.O Box 208265, New Haven, CT 06520, USA. hannah.brueckner@yale.edu
    Abstract
    PURPOSE:

    To examine the effectiveness of virginity pledges in reducing STD infection rates among young adults (ages 18-24).
    METHODS:

    Data are drawn from the National Longitudinal Study of Adolescent Health, a nationally representative study of students enrolled in grades 7-12 in 1995. During a follow-up survey in 2001-2002, respondents provided urine samples, which were tested for Human Papilloma Virus, Chlamydia, Gonorrhea, and Trichomoniasis. We report descriptive results for the relationship of pledge status and sexually transmitted disease (STD) rates as well as health behaviors commonly associated with STD infection.
    RESULTS:

    Pledgers are consistently less likely to be exposed to risk factors across a wide range of indicators, but their STD infection rate does not differ from nonpledgers. Possible explanations are that pledgers are less likely than others to use condoms at sexual debut and to be tested and diagnosed with STDs.
    CONCLUSIONS:

    Adopting virginity pledges as intervention may not be the optimal approach to preventing STD acquisition among young adults.

    (PubMed 15780782)

    The entire article is available at the Journal of Adolescent Health website.

    There are other studies on the internet about preteens and teens woeful lack of knowledge about STDs and the routes of sexual transmission (other than intercourse).

  131. #132 laura
    September 8, 2011

    @lilady-

    I guess you did not read the link from Merck from 2011 about the results of the research in older women 27-45.

    http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html

  132. #133 lilady
    September 8, 2011

    Oh yes I did…I made reference to the research that was ongoing as detailed in the updated American Cancer Society Recommendations…your point being that the research is complete and the recommendations remain?

  133. #134 herr doktor bimler
    September 8, 2011

    Is this the same “laura” who cited this junk science press release yesterday with the notation:

    Is this the same Laura who trolled industriously all through the “Closed Mindset” thread, threatened to turn anti-vax in retaliation for the unsympathetic responses from other commenters, and finally promised that this would be “definitely her last post”?

    She seems to have the same bookmarks as JJ.

  134. #135 lilady
    September 8, 2011

    @ herr doktor bimler: That would be “our” laura…the same “our laura” who first stated:

    Gardasil Safe? NOT!

    “Our laura” also provided an “ethics” lecture on the vaccine and outdated four year old recommendations from the American Cancer Society.

    Kinda makes me wonder if “our laura” is stuck in a time warp and is a (not so) closeted anti-vaxer.

  135. #136 MrPink
    September 9, 2011

    Shall we summarize Orac’s argument? Impossible task. How about summarizing the playbook?

    1. Start with inane ramble and ego boost — check
    2. Attack the messenger — check
    3. Associate messenger with everyone we don’t like — check
    4. Question the results by attacking the lab — check
    5. Discredit the lab by associating expert to someone we don’t like through innendo — check
    6. Copy something scientific from textbook to sound smart and pretend you know something about the problem — check
    7. Include pictures if possible to reenforce ego and air of intelligence — check
    8. Include caveats in case the lab reports were right — check
    9. Assure everyone that even if the reports were correct, the problem is harmless — check
    10. Reminisce about personal expertise and pretend to have looked into this decades ago — check
    11. To ensure uncertainly make sure to go back and attack the messenger and expert again — check
    12. Appeal to the faithful masses by topping off with inane insult, the more familiar the better — check

    Mockery aside, let us condense the heart of the argument:

    1. Attack the lab result
    a) Attack the expert
    b) Attack the lab process

    2) Even if the lab result was true, Orac can’t figure out how it could be harmful therefore it’s not

    So the best we got for 1A is that Dr. Lee is popular in the lyme disease community for creating a lyme disease test? Stop the presses for a second! Somehow Orac would have us all believe that creating a technology to perform a lyme disease test that increases the diagnostic accuracy by 85% over routine clinical testing is nefarious?

    In 1B Orac attacks the process by… wait for it… explaining the basics of DNA testing. Huh? Wait, it actually seems that Orac is whining about lack of details and the desire of someone to protect their research diagnostic methods from the public or competitors. Not just whining, making all sorts of asusmptions without an ounce of detail. Huh? Apparently, pharmaceuticals are more than welcome to protect their intellectual property, but Dr. Lee is not able to protect his own technology because Orac says so? Huh? Ooops, I guess I missed the whining part from the playbook.

    I guess it’s not surprising that a staunch defender of establishment science would instantly attack without knowing any details an improved method and technology for DNA testing, but the hypocrisy of denying the right to protect proprietary technology is pretty quaint. tsk tsk.

    Of course the ultimate irony is that Orac talks about the technology and Dr. Lee as if he himself is an expert, and Dr. Lee merely a hack trying to get press with those Auntie Maxine collaborators.

    I guess that’s why Dr. Lee is writing chapters in textbooks on PCR testing while Orac is writing cheezy blogs for pay on a site selling quackery ads to anyone.

    Moving on…
    The evidence for this? None. The support for the argument? Orac did some non-specific work as a grad student. Huh? That’s convincing? No references? Scientific publications? LOL.

    There is a reason Merck advertised quite clearly that there was NO HPV DNA in the vaccine. It is entirely scientifically plausible that the rDNA can be integrated and taken up by cells in the body. If the rDNA is indeed found in the vaccine contrary to the conditions of the regulatory approval, that approval should be revisited, and the situation should be studied. Medical prudence would demand it.

    But really Orac, you put on a good show, and you even included diagrams! Judging from the inane comments here, I’m sure you made a bit of extra cash from the ad clicks by entertaining the riff raff.

    But please be sure to get back to all of us with the test results of your own lab. We would love to know how you plan to detect the rDNA while attached to the aluminum adjuvant?

  136. #137 TBruce
    September 9, 2011

    MrPink:

    You should apply for a job at Cineplex.

  137. #138 Matthew Cline
    September 9, 2011

    @MrPink:

    In 1B Orac attacks the process by… wait for it… explaining the basics of DNA testing. Huh? Wait, it actually seems that Orac is whining about lack of details and the desire of someone to protect their research diagnostic methods from the public or competitors. Not just whining, making all sorts of asusmptions without an ounce of detail. Huh? Apparently, pharmaceuticals are more than welcome to protect their intellectual property, but Dr. Lee is not able to protect his own technology because Orac says so?

    They could patent the method/procedure, but instead are keeping it a trade secret. Doing that is pretty strange, since if somebody else duplicates their work then that somebody could patent it and they’d lose the right to use it. If they patented it then they could share the method with the whole world, not just the FDA, while still protecting the method for 21 more years. So the fact they’re using trade secret protection rather than a patent is somewhat suspicious.

    Also, lets say that the FDA did accept the non-disclosure agreement and evaluated the method/technique used. One of two things can happen:

    1) The FDA agrees with the test, but Merck challenges the test, saying that it hasn’t been properly validated, and wants to know the details of the method so it can defend itself. Does Merck get to look at the trade secrets of a potential competitor?

    2) The FDA disagrees with the test (but isn’t permitted to say why it disagrees), and the FDA is accused of being in the pocket of Merck. How can either the FDA or Dr. Lee prove themselves to be in the right when the method remains a trade secret?

    So it would be better all around if the method was patented to that everyone can review the test and the method can be submitted to peer review.

  138. #139 Composer99
    September 9, 2011

    MrPink: tl;dr; – especially once it became clear that your verbose rant was substance-free.

    As usual, the commenters provide extra oomph to Orac’s criticisms; see for example qetzal here.

  139. #140 lilady
    September 9, 2011

    “So the best we got for 1A is that Dr. Lee is popular in the lyme disease community for creating a lyme disease test? Stop the presses for a second! Somehow Orac would have us all believe that creating a technology to perform a lyme disease test that increases the diagnostic accuracy by 85% over routine clinical testing is nefarious?”

    Orac never said that the Lyme disease test developed by Dr. Lee was, to use your word, nefarious. You seem to be an expert on Lyme disease and Lyme disease testing…so:

    Where are the citations from peer-reviewed journals for reliability/accuracy of Dr. Lee’s Lyme disease test? Would you care to expand on your opinion by including the test’s sensitivity versus the test’s specificity and compare Dr. Lee’s test for Lyme disease with other tests for Lyme disease?

    Aside from your personal attacks on Orac and other posters here, you have provided no published research. Or, would you like to share with us research that you have done and your findings?

  140. #141 mrpink
    September 10, 2011

    @matthewcline
    I’m guessing you don’t really work in the high tech field given that you think keeping a trade secret vs patenting is suspicious? Either that or you’re completely ignorant of the business decisions involved in making money from technology. I recommend googling trade secret vs patent and do some basic research on the differences between them.

    So, no, it might not be better all around if it were patented. It is entirely plausible for a company to a) license the technology b) agree to not copy it without licensing it.

    You guys all seem to be obsessed with conspiracy…

  141. #142 MrPink
    September 10, 2011

    @composer99,
    “tl;dr; – especially once it became clear that your verbose rant was substance-free.”
    Since you followed up your comment with a prime example, I suppose Orac take solace from your post because mimicry is the sincerest form of flattery.

    @lilady, you expect me to answer your strawman? Please. I doubt you would even be able to understand the research since you apparently think that HPV vaccine protects against 70% of cervical cancer. I think you should re-read that peer-reviewed science because they never definitively claim the vaccine actually prevents cervical cancer. It’s only approved based on preventing HPV infection.

  142. #143 lilady
    September 10, 2011

    I’m guessing you don’t really work in any of the science-based medicine fields given that you think that any laboratory test that is done in one lab exclusively and isn’t licensed is not suspicious? Either that or you’re completely ignorant of what is acceptable evidence of accuracy in in the fields of medicine, bacteriology and virology and which would involve independent testing with lab “controls”.

    So, no, it might not be better all around if it were patented. It is entirely plausible for a company to a) license the technology b) agree to not copy it without licensing it….Except that Dr. Lee has neither patented or licensed his Lyme PCR test or his HPV rDNA PCR test.

    You seem to be obsessed with conspiracy…and also seem to be “projecting”.

    So where are the citations from peer review journals to prove that Dr. Lee’s Lyme disease test has an 85 % accuracy rate and where is the research that compares Dr. Lee’s Lyme test in terms of sensitivity and specificity, with other Lyme disease tests?

  143. #144 Matthew Cline
    September 10, 2011

    @MrPink:

    It is entirely plausible for a company to a) license the technology b) agree to not copy it without licensing it.

    The issue with trade secrets isn’t so much the matter of licensing, but the danger of someone else interdependently duplicating/recreating the invention.

    I recommend googling trade secret vs patent and do some basic research on the differences between them.

    I did recently Google on trade secrets vs patents. From what I understand, trade secrets are preferable to patents if one of the following apply:

    1) It’s unlikely anyone else will duplicate the invention in the next 21 years, since if someone else duplicates a trade secret there’s nothing you can do about it.

    2) The invention is likely to be duplicated in a few years time, but in a few years the invention will be worthless.

    3) While the invention will bring a profit, the lifetime profit of the invention is less then the cost of filing a patent.

    I really doubt that a single person could single-handedly come up with a breakthrough that’s 21 years in advance of everyone else. #2 and #3 could make sense if the method/technique can only be used to detect HPV genetic material, but a method of detecting genetic material that’s bound to an adjuvant, but only if that genetic material is from HPV, doesn’t really make sense.

  144. #145 lilady
    September 10, 2011

    Me thinks Mr. Pink confuses me with the recommendations from the American Cancer Society Recommendations regarding the protective value of the strains of HPV that are contained in the vaccine:

    “These vaccines protect against 70% of cervical cancers. But the vaccines don’t protect against all cancer-causing types of HPV, so cervical cancer can happen even in women who have been vaccinated. Vaccinated and unvaccinated women should still to be screened for cervical cell changes with Pap tests and other tests, according to current ACS early detection guidelines.”

    I also think that Mr. Pink needs some reading comprehension assistance insofar as he doesn’t understand the preventive nature of the vaccine to protect sexually naive young women, before the have sexual encounters…so that when they reach the age (45), of the typical patient diagnosed with cervical cancer, they are completely protected against the 70 % of cervical cancer that are directly attributable to the strains of HPV that are contained in the vaccine.

    “lilady, you expect me to answer your strawman? Please.”

    Excuse me, you raised that Lyme test strawman argument and I am just calling you on it. Why not prove me wrong and provide the independent research, showing sensitivity and specificity for Dr. Lee’s Lyme disease test versus other Lyme disease tests?

  145. #146 Matthew Cline
    September 10, 2011

    Also:

    1) If aluminum adjuvant being attached to a DNA strand prevents it from being detected by normal PCR, it will also prevent the DNA from being expressed or copied inside of a cell.

    2) Since the adjuvant is added after the virus-like particles are formed, any DNA they bond to is going to be outside of the particles, and hence unable to infect cells via the particles.

  146. #147 herr doktor bimler
    September 10, 2011

    Dr Lee is certainly a busy man, what with sending out the press releases for his special cancer-preventing green tea,* and for his special lyme-disease test (you would not believe how many people visiting Milford Hospital for any reason turn out to be suffering from Lyme Disease), and now for his proprietory HPV test, fine-tuned to detect only the carcinogenic versions of the virus (which is why he wants the FDA to use it instead of whatever they’ve approved at the moment).

    One has to admire his entrepreneurial zeal.

    * Apparently (1) Green tea is well-known for its health benefits; but (2) normal green tea does not contain enough of the active ingredient to have any health benefits, so you have to drink Dr Lee’s own specially-sourced blend.

  147. #148 lilady
    September 10, 2011

    @ herr doktor bimler: Yes, Dr. Lee certainly has been busy writing letters about his PCR test for HPV rDNA to the commissioner of the FDA…expecting acceptance for this new test with absolutely no data to back it up.

    Dr. Lee also has a slew of correspondence (available on the internet) from the FDA about the purported anti-oxidant benefits of his green tea and his “advertising” of the benefits…it’s not going well for him.

    Being that all the allegations that Mr. Pink made in his long screed are unverifiable…I questioned him about the Lyme disease test statement about sensitivity and specificity versus other Lyme disease tests and Mr. Pink seems unwilling (or unable) to provide the research to back up his statement. Well I’m still waiting…

  148. #149 laura
    September 10, 2011

    Comment by a well known physician (name remains unknown)-Re Vioxx

    For science-based medicine to be accepted and trusted by the public, the public must be sure that the clinical trials designed to test the safety and efficacy of new drugs conform to the highest standards of science. More importantly, they must know that these trials are as free from bias and hidden agendas as is humanly possible to achieve. Also, a personal standpoint, I detest Merck’s actions because it will make it that much more difficult for honest clinical investigators like myself to win patients’ trust and persuade them to agree to participate in clinical trials, particularly trials in which a pharmaceutical company is involved but the distrust will spill over to all clinical trials, even NIH-funded trials.

    My comment-I still don’t trust Merck.

  149. #150 MrPink
    September 10, 2011

    @matthewcline
    “The issue with trade secrets isn’t so much the matter of licensing, but the danger of someone else interdependently duplicating/recreating the invention.”

    Yes. But what does that have to do with licensing? The non-issue you raised in the false dichotomy above is that Merck wouldn’t be able to validate the results themselves. Who says Merck couldn’t license the technology?

    “#2 and #3 could make sense if the method/technique can only be used to detect HPV genetic material, but a method of detecting genetic material that’s bound to an adjuvant, but only if that genetic material is from HPV, doesn’t really make sense.”

    You are making so many limiting assumptions without knowing any details. Of course your concocted scenarios don’t make sense. You don’t know the nature of the technology used, it might not even be patentable, it might only consist of information that took years to find, but once found, is quite valuable and easy to copy. It could also be a combination of technologies combined. The point is your false dichotomy is based on massive assumptions and is therefore false. There are far more alternative scenarios available than the two you listed.

    Also, Dr. Lee hardly works alone. The testing from his published papers were done in a professional lab. You might also note that some of the technology is based on expired patents per the website.

    “1) If aluminum adjuvant being attached to a DNA strand prevents it from being detected by normal PCR, it will also prevent the DNA from being expressed or copied inside of a cell.
    2) Since the adjuvant is added after the virus-like particles are formed, any DNA they bond to is going to be outside of the particles, and hence unable to infect cells via the particles.”

    Assuming no process in the body ever breaks it down first. Your limiting assumptions are astounding. It’s unbelievable that given a complete void of any pharmacokinetic data, you make such definitive proclamations.

    @herr docktor bimler
    “(you would not believe how many people visiting Milford Hospital for any reason turn out to be suffering from Lyme Disease)”
    I suppose you would not believe how many people going to Barbara Ann Karmanos Cancer Institute end up having surgery? What nonesense.

  150. #151 Chris
    September 10, 2011

    Wow. Just wow.

    Just for the record, an opinion from an anonymous source is not actual evidence of anything. The only response would be Who cares?”

  151. #152 laura
    September 10, 2011

    @chris-

    This is a quote from Orac’s blog on Bioethics • Clinical trials • Medicine
    Posted on: August 21, 2008 9:00 AM, by Orac

  152. #153 Chris
    September 10, 2011

    So what? More than likely it was taken out of context. And when we find the link, that you decided to not include:
    http://scienceblogs.com/insolence/2008/08/when_clinical_trials_are_designed_by_marketing.php

    Looking at the article, we do find you taking quotes out of context. Laura, do you know what that is called? Lying. Please stop lying.

  153. #154 laura
    September 10, 2011

    @chris-
    You are seriously delusional-READ READ the comment- There is no way
    this is at all lying.

    It’s a good quote.

  154. #155 Chris
    September 10, 2011

    Laura, you are implying a meaning that was not meant in the actual article. If that is not lying, it is you being extremely stupid.

    You might also want to read the link given by qetzal up thread:
    http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

  155. #156 laura
    September 10, 2011

    I didn’t include the link because my links are no longer showing up- they are being
    held in moderation.

  156. #157 laura
    September 10, 2011

    @chris-
    Merck used an aluminum adjuvant in placebo drugs in one of their Gardasil
    trials.
    Also my link to Dr. Diane Harper’s reservations about this drug was not posted-
    Look it up for yourself.

  157. #158 laura
    September 10, 2011
  158. #159 Chris
    September 10, 2011

    Again, so what? You did not even post the title of the article.

    Everyone agrees Merck screwed up with Vioxx. But that is not a vaccine, and has no reflection on the safety or efficacy of any vaccine.

    Again, another person’s personal opinion on how she thought some of the testing should have been done renders a “so what?” response. Bring up some real scientific literature to support your opinion, and you might have something. But all I see is random hand waving.

  159. #160 Lawrence
    September 10, 2011

    Manic hand-waving seems to be a favorite troll pasttime.

  160. #161 laura
    September 10, 2011

    @chris-
    FYI- Dr. Diane Harper was one of the developers of Gardasil-
    I can’t believe you are so dense.

  161. #162 Chris
    September 10, 2011

    Yes, she was “one.” She is one person with an opinion. Again a bit “so what?” response.

    Are you getting lots of exercise with all that hand waving?

  162. #163 Lawrence
    September 10, 2011

    Which would lead me to believe, given her position, that Gardasil testing was more than adequate, yes?

  163. #164 Krebiozen
    September 10, 2011

    Laura,

    Orac’s comments were directed at Merck’s use of seeding trials as a form of advertising, and have no relevance to Gardasil’s safety. Leaving out the last sentence of the paragraph you quoted changes its meaning.

    The page you link to claims that Dr. Diane Harper was the “lead developer of Gardasil®” which is not true, though she was involved in some of the trials of Gardasil, and also Cervarix. Dr. Harper was badly misquoted after making some statements to the press two years ago criticizing Merck’s marketing of Gardasil, as at that time it was less clear how long the protection given by the vaccine would last.

    When contacted by Dr. Ben Goldacre in 2009 Dr. Harper said, “I fully support the HPV vaccines, I believe that in general they are safe in most women”.
    http://www.badscience.net/2009/10/jabs-as-bad-as-the-cancer/

    Keep going Laura, if you keep slinging mud, maybe sooner or later you will find some that sticks. In the meantime, be sure to ignore anything that suggest that Gardasil is remarkably safe and effective and will save thousands of lives.

  164. #165 Chris
    September 10, 2011

    Krebiozen:

    Leaving out the last sentence of the paragraph you quoted changes its meaning.

    Which, as I said before, is a form of lying. Taking quotes out of context is lying.

    Thank you very much for linking to the Ben Goldacre article. I was puzzled by the “developer” label, when all of the articles with her name pertained to testing.

  165. #166 laura
    September 10, 2011

    @krebiozen- please address the aluminum adjuvant in placebos in clinical trials-
    that was my point.

    This is what you said above-
    “In the meantime, be sure to ignore anything that suggest that Gardasil is remarkably safe and effective and will save thousands of lives.”

  166. #167 Chris
    September 10, 2011

    Laura, you are further waving your hands by changing the subject.

    Again, why should we care that you claim “Merck used an aluminum adjuvant in placebo drugs in one of their Gardasil trials.”? You made a statement without any supporting evidence, nor any scientific literature to show that it is an issue.

    Aluminum adjuvants have been used safely in the USA for decades. You consume more aluminum every day than are in several vaccines. And if you scraped your knee in dirt you’d get more aluminum. Really, it is a non-issue.

    What exactly do you have against protecting young women from cancer? Do you have some desire that they suffer from a sexually transmitted virus?

  167. #168 laura
    September 10, 2011

    From Merck’s patient warnings- April 2011

    Who should not get GARDASIL?

    You should not get GARDASIL if you have, or have had: •
    an allergic reaction after getting a dose of GARDASIL. •
    a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

    Girls have died from Gardasil.

  168. #169 Chris
    September 10, 2011

    Again, so what? Allergy warnings are common with all medicines.

    Now the statement “Girls have died from Gardasil.” is worthless without supporting scientific documentation. Motor vehicle accidents after receiving the vaccine do no count.

  169. #170 Krebiozen
    September 10, 2011

    Laura,

    please address the aluminum adjuvant in placebos in clinical trials

    Aluminum adjuvants at worst, and rarely, cause local inflammation at the injection site. Clinical trials of Gardasil were designed to test the effects of the antigens in the vaccine, so in some (but not all) of them it was compared to the vaccine without the antigen, but including the adjuvant, so the effects of the antigen could be assessed. I don’t really see your point. Are you suggesting that aluminum adjuvants kill people?

    Girls have died from Gardasil.

    Have they? The FDA doesn’t seem so sure. If you are claiming that anyone has died of anaphylactic shock due to Gardasil, I would be interested in some details. No one should die of anaphylactic shock due to a vaccine, it appears within a few minutes when due to an injection, and anyone administering a vaccine should have epinephrine to hand in case of an allergic reaction.

    This is what you said above-“In the meantime, be sure to ignore anything that suggest that Gardasil is remarkably safe and effective and will save thousands of lives.”

    You seem to have taken me more literally than I intended.

  170. #171 laura
    September 10, 2011

    @krebiozen-

    Take me literally- ….and make millions for Merck.

  171. #172 Chris
    September 10, 2011

    Again, so what?

    The company’s earning have no bearing on the safety or efficacy of the vaccine.

  172. #173 laura
    September 10, 2011

    Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle

    http://brain.oxfordjournals.org/content/124/9/1821.abstract

  173. #174 herr doktor bimler
    September 10, 2011

    the aluminum adjuvant in placebos in clinical trials- that was my point.

    The existence of safety tests conducted on the adjuvant proves that the adjuvant must be unsafe? Really?
    I don’t know why the FDA is so resistant to this idea that the less you test vaccines and drugs, the safer they must be.

  174. #175 Chris
    September 10, 2011

    “Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle”

    Now that is some serious hand waving. The vaccines cause sore arms according to that ten year old article:

    At this point, an epidemiological survey aimed at evaluating the putative link between long-term persistence of MMF lesions at sites of vaccine injection and systemic symptoms is required. Meanwhile, there is no basis for recommending a change in HBV vaccination practices (WHO Vaccine Safety Advisory Committee, 1999).

    Again, so what?

    Seriously, what do have against preventing cancer in women?

  175. #176 herr doktor bimler
    September 10, 2011

    Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle

    The University of Google Scholar reveals a sizable literature about Macrophagic myofasciitis, most of it coming from the French group who first claimed that it exists (who are now publishing in Medical Hypotheses). Others dispute its etiology and its very existence.

    If laura wants to conduct a literature review, I imagine Orac wouldn’t mind her reporting her conclusions in a comment thread, though it’s getting rather away from her original preoccupation with the SANE Vax claims about DNA.

  176. #177 Chris
    September 10, 2011

    How serious this condition is considered is in a paper that was in the short list of papers that cite the French guys: Macrophagic Myofasciitis in Children Is a Localized Reaction to Vaccination. It says:

    There was no correlation between histological findings of macrophagic myofasciitis in biopsies and the clinical symptoms. We believe that macrophagic myofasciitis represents a localized histological hallmark of previous immunization with the aluminum hydroxide adjuvants contained in vaccines, rather than a primary or distinct inflammatory muscle disease.

    Which is another way to say: Eh, so what?

  177. #178 laura
    September 10, 2011

    @herr doktor-
    Correct- I went off topic though you weren’t entirely correct in your reporting of
    Dr. Lee’s work-
    (Green tea topic and Lyme disease not relevant from other poster)

  178. #179 Chris
    September 10, 2011

    So, exactly what problem do you have in preventing a viral infection that causes cancer?

  179. #180 herr doktor bimler
    September 10, 2011

    (Green tea topic and Lyme disease not relevant from other poster)
    I think you will find the words “Lyme disease” actually appearing in the original post.

    On this issue of “macrophagic myofasciitis”, I’m assuming that you’ve skimmed the literature, because without that context you can’t tell much about the validity of a single paper from 10 years ago. So why not tell us your conclusion?

  180. #181 laura
    September 10, 2011

    @chris-

    based on this link from the JAMA and everything I’ve read so far I would not advise my daughter-in-law to get the vaccine for her daughters IF ASKED.

    The Risks and Benefits of HPV Vaccination

    http://jama.ama-assn.org/content/302/7/795.full?home

  181. #182 Chris
    September 10, 2011

    From that editorial they claim the HPV vaccine only protects for only “HPV-16 and HPV-18″, which is not Gardasil (which has four strains). It also relies too much on VAERS. You should read the two replies.

    You are really reaching, and raising those hands in hand waving.

    Really, what do you have against protecting women from cancer?

  182. #183 Todd W.
    September 10, 2011

    Man. Just catching up with the comments and see that Laura has been busy shifting the goalposts all over the place.

    Laura, I get that you are terrified of Gardasil. It has an aluminum adjuvant (which has decades worth of safe use in humans in the U.S.). It might cause a serious allergic reaction (which is easily managed with an epipen and so, under normal circumstances, is a relative non-issue). You think that girls have died from the vaccine (despite the FDA having investigated the reports and found no connection at all). It makes money for its manufacturer (why shouldn’t it? Doesn’t the car you drive make money for the company that made it? What about the food you eat; doesn’t that profit the companies and farmers involved in their production? Do you get paid for the work you produce, or should you just do it out of the goodness of your heart?).

    Now, when the vaccine was first approved, I was a bit wary of it myself. There’s always some uncertainty as to how a medical product will behave once it is used in the real world, far from the pristine and well-controlled world of clinical trials. But Gardasil has been around for quite a while, now. It has certainly been used in a large enough group of people for unexpected and rarer side effects to be noted. Yet we haven’t seen them.

    As to efficacy, it is still too early to tell how well it will prevent cancer, but data suggests that so far it’s working pretty well at preventing infection with the 4 strains for which it was designed to grant immunity. Time will tell the ultimate power of the vaccine to prevent certain types of cancer.

    If you really take a look at reliable information about the vaccine, you would see that it is safe (in a relative sense; nothing is 100% safe). I’m curious to know where your fear started. What first made you so afraid of the vaccine?

  183. #184 herr doktor bimler
    September 10, 2011

    From that editorial they claim the HPV vaccine only protects for only “HPV-16 and HPV-18″, which is not Gardasil (which has four strains).
    The author is not entirely consistent… elsewhere in the Editorial she refers to “quadrivalent HPV vaccine”.

  184. #185 Krebiozen
    September 10, 2011

    I think VLP vaccines are amazing. For HPV they induce a much greater immune response than natural infection conferring almost 100% protection against their target viruses in naive patients, and they are neither infectious, nor oncogenic. Even the critical article Laura linked to states, “The theory behind the vaccine is sound: If HPV infection can be prevented, cancer will not occur”.

    We have every reason to believe Gardasil will be proven safe and effective, very probably producing lifelong immunity, though of course it is only sensible to continue surveillance to be absolutely sure. There is currently a polyvalent HPV vaccine being developed that will protect against 9 types of HPV, and no doubt we will eventually have a vaccine that protects against all human-infecting types.

    Most criticisms of Gardasil seem to be of the form:
    The vaccine doesn’t work against viruses it isn’t designed to work against (though it looks as if it does, to some extent).
    The vaccine doesn’t work backwards in time to prevent infections people already have.
    It will take years to reduce incidence of cervical cancer.

    I don’t find these criticisms very convincing.

  185. #186 herr doktor bimler
    September 10, 2011

    That JAMA editorial goes on to suggest that the increased cancer risks from HPV infection can be managed by regular screening… which might well be true in countries with decent public-health systems, such as the author’s native Norway.

  186. #187 laura
    September 10, 2011

    @herr dok
    Read again
    HPV-16 and HPV-18 are oncogenic strains
    HPV- 6 and HPV -11 cause genital warts.

  187. #188 Chris
    September 10, 2011

    I was a bit suspicious when she kept referring to “the HPV vaccine” when there was more than one. She has the proper qualifications, but for almost the last decade she has been an editor of a journal, not really in research.

    It reminds me of one doctor who posted a while ago her misgivings about HPV vaccination, saying that we could reduce it by teaching our children to abstain from sex, etc. It was a morality issue. I kept asking her for the time machine to predict whether or not my daughter’s future husband would be HPV free. She never answered.

    I just realized how long ago Gardasil has been around, but daughter received them about four years ago. Today she is moody and non-communicative, but I figure that it is because she is seventeen and I asked her to clean something up.

  188. #189 herr doktor bimler
    September 10, 2011

    I was a bit suspicious when she kept referring to “the HPV vaccine” when there was more than one.

    At one point the author adds to the unclarity by referring specifically to “the 2 virus strains included in the vaccine”.

  189. #190 lilady
    September 10, 2011

    Gee, I missed out on all the fun while I was unavoidably detained elsewhere…hosting my daughter’s wedding reception.

    I see that Mr. Pink has not returned and in his place we have laura who chastises me for questioning Pink’s sole verifiable statement about the sensitivity of 85 % of Dr. Lee’s Lyme disease blood test.

    If you recall laura…Pink launched into a scurrilous unwarranted attack on Orac and the posters here and put words into Orac’s mouth when Orac merely mentioned that Dr. Lee had licensed a Lyme disease test; here is Pink’s original statement:

    “So the best we got for 1A is that Dr. Lee is popular in the lyme disease community for creating a lyme disease test? Stop the presses for a second! Somehow Orac would have us all believe that creating a technology to perform a lyme disease test that increases the diagnostic accuracy by 85% over routine clinical testing is nefarious?”

    This is my reply:

    “Orac never said that the Lyme disease test developed by Dr. Lee was, to use your word, nefarious. You seem to be an expert on Lyme disease and Lyme disease testing…so:

    Where are the citations from peer-reviewed journals for reliability/accuracy of Dr. Lee’s Lyme disease test? Would you care to expand on your opinion by including the test’s sensitivity versus the test’s specificity and compare Dr. Lee’s test for Lyme disease with other tests for Lyme disease?”

    I asked Pink several times for citations about the diagnostic accuracy and for comparisons of Dr. Lee’s Lyme disease blood test and other Lyme Disease blood tests in terms of specificity and sensitivity and he didn’t reply…so I guess he’s just another flame-thrower troll.

    Aluminum adjuvants in vaccines have been used for the past 70 years. This adjuvant is contained in the HPV vaccine and hepatitis A, hepatitis B, DTaP, TDap and the HIB vaccines as well…so why would a young girl who has had all the doses of theses other vaccines, suddenly have a reaction to the aluminum adjuvant contained in HPV vaccine?

    There have been many VAERS reports citing “serious” events and even “deaths” supposedly attributed to the HPV vaccine but nary a one claiming anaphylaxis after the vaccine. Again “anyone” can and “anyone” does make reports of events or deaths following administration of the vaccine. It is all part of the contamination of the VAERS system due to the virulent anti-vax sites such as SANE Vax, AoA, NVIC and others who first encourage people to download the report form, fill it out with supposed severe reactions/deaths and then quote those same VAERS reports to back up their allegations of vaccines being unsafe.

    I stated before and I will state it again. I have administered thousands of vaccines and my colleagues at the health department where I was employed collectively have administered hundreds of thousands of vaccines…and none of us ever had to use an epinephrine injection following vaccination. I know most of the pediatricians and most of the family medicines doctors who practice in my county and none have ever reported anaphylaxis following vaccination.

    Thanks Chris, for provided the terminology (macrophagic myofasciitis) for the dull ache I experienced for several weeks following each of the three immunizations I received against hepatitis B…that’s why doctors and nurses always administer vaccines in the patient’s non-dominant arm.

  190. #191 Brian Walsh
    September 13, 2011

    I wonder if the regular commenters here could help me out with a favor. Leslie Botha is the public relations director for SANEVax. She also has a radio show during drive time on 88.9 FM KRFC Fort Collins in Colorado. The show is called Holy Hormones Honey! and it’s a rather blatant propaganda tool for SANEVAX and the anti-vaccine movement in general. I also have a show on this station, a talk show about science and skepticism, and have been increasingly incensed that she is allowed to spew this (in my opinion) murderous nonsense over the air. I have complained about the content of her show many times, but the station management, like so many people, believes the CAM community is legitimate science. This may change if people in greater numbers than just me make their voices heard to the management.

    I haven’t taken this to others before now out of a misguided sense of family amongst programmers, but she continues to cross the line, her show started off as a general topic alt-med show, it is purely anti-vax nonsense and anti-science hatred now. (Her episode calling for people convicted of shaking babies to death to be released because it was actually vaccines that killed them is a classic.) Like the management, people who are not exposed to science are prone to believe she is citing accepted science.

    Please help by calling, E-mailing and tweeting KRFC and making your opinion heard. Calling would be by far the most effective. I am going to post this in the other thread that mentioned SANEVax as well. I don’t mean this as spam. Ending such a loud voice for SANEVax would certainly be a tremendous blow. Also, If Orac or anyone else here has a suggestion on how to take this plea to a wider audience, please let me know. Thanks.

    Her website is here: http://holyhormones.com/
    The contact page for KRFC is here: http://www.krfcfm.org/contact-krfc/

  191. #192 Chris
    September 13, 2011

    Have you tried Phil Plait, the Bad Astronomer? He lives in Boulder.

  192. #193 Liz Ditz
    September 13, 2011

    Brian @191: check the rational-alchemy feedback email account — I introduced you via email to the Colorado Children’s Immunization Coalition — they did strong work when Wakefield visited Boulder.

    I have a couple of other thoughts too, which I’ll share via email to the rational-alchemy account.

  193. #194 crassfrazier
    September 25, 2011

    Yea…right on reasonable people! Thanks for pointing out all the fear mongering SANE-Vax inflicts on the ignorant population. For a while I was led to believe it was the politically powerful, profit motivated corporations who (oops…I mean that) were doing the fear mongering…what’s to fear in the suggestion of a future bout of cervical cancer in your daughter? Thanks for clearing that up for me…OBVIOUSLY these pharmaceutical companies can be trusted in dictating public health issues…they must have some real scientists on the payroll, somewhere, right?

  194. #195 LW
    September 25, 2011

    You know, I always have difficulty understanding the “that’s fear-mongering!” argument. Does the risk warned about actually exist? In the case of HPV, it appears that the answer is yes, some strains of HPV are implicated in cervical cancer, they are wide-spread, people who are infected often don’t know it and therefore spread it unwittingly. Is it fear-mongering to say these things? Can you, crassfrazier, suggest a test I can use to distinguish between warning of a possible risk and fear-mongering?

  195. #196 Antaeus Feldspar
    September 25, 2011

    what’s to fear in the suggestion of a future bout of cervical cancer in your daughter?

    So your preference is that if science figures out a way that we can lower the risk of death from cancer in your daughter’s future… you’d rather not know about it, or take any steps to prevent it?

    The reason that we call organizations like “SANE-Vax” fear-mongering is not because they bring up possibilities that are frightening, but because they generate fears that have, at best, very dubious “science” behind them. If you actually read the article you commented on, you’d have realized that: the entire discovered “contamination” on which their big press push is founded is based entirely on a single scientist’s claimed methodology that has never passed peer review (and seems unlikely to be ever even submitted for peer review!) and the supposed consequences of the supposed contamination based on some incredibly unlikely presumptions about gene transfer.

    By contrast, your logic could be charitably described as “the science behind Gardasil is dubious, because pharmaceutical companies stand to profit if Gardasil is purchased.” That’s hardly compelling logic, as it’s a textbook case of ad hominem circumstantial.

  196. #197 Janerella
    October 7, 2011

    Just letting you know the lunatic fringe (found it via a link on the toxic Australian Vaccination Network FB page) is touting this new article in a fairly mainstream New Zealand magazine about the abovementioned pseudoscience.
    http://www.drjudithreisman.com/archives/2011/10/the_tale_of_two.html

  197. #198 lilady
    October 7, 2011

    @ Janerella: I suppose there is small comfort in knowing that the New Zealand anti-vaccine loonies are just as crazy as the loonies we have here in the United States.

    I “googled” Judith Reisman at the whale.to website and they have pages devoted to other “investigative” reports and studies done by Reisman. She’s a real head case and has devoted her “professional career” to the study of her particular theories of human sexuality and has written some dreadful articles about the perversity of homosexuality and psycho-sexual conspiracies.

  198. #199 herr doktor bimler
    October 7, 2011

    a fairly mainstream New Zealand magazine

    Not sure about describing “Investigate” (or a spinoff thereof) as “mainstream”. I think everyone in NZ knows it’s conspiracy-theory-of-the-day lunacy with a right-wing emphasis. Even the readers know it.

  199. #200 Antaeus Feldspar
    October 7, 2011

    Ah, Judith Reisman – she’s the one who promotes that ridiculous “erototoxin” nonsense, isn’t she? (Short version: Looking at porn makes your brain flood with EEEEEEVIL neurotransmitters that alter the physical structure of your brain and make you a violent zombie.) Not surprised if she’s got the crank magnetism going on; I wonder if she hates all vaccines, or just hates Gardasil because it’s associated with people at some point in their lives having sex.

  200. #201 Broken Link
    October 7, 2011

    Sane-Vax is now reporting bad news for Dr. Sin Hang Lee, the person who did the analysis. “his position as director of the laboratory was summarily terminated along with his employment relationship at Milford Hospital on December 13, 2010 and he has been prevented from using the hospital’s laboratory to continue his testing and research there ever since that time.”

    We are supposed to believe this is a giant conspiracy theory. But look at the dates. He was terminated almost a year ago, well before Sane-Vax began to publicize these “results”.

    Click on my ‘nym for the URL.

  201. #202 lilady
    October 7, 2011

    “I wonder if she hates all vaccines, or just hates Gardasil because it’s associated with people at some point in their lives having sex.”

    I read through the first “article” (an interview of Reisman) featured on the whale.to site (Salvo, Spring ’07) and of course Reisman is against Hepatitis B shots, as well.

  202. #203 Professor Blackheart
    December 9, 2011

    Laura

    FYI ToddW said

    I get that you are terrified of Gardasil. It has an aluminum adjuvant (which has decades worth of safe use in humans in the U.S.). It might cause a serious allergic reaction (which is easily managed with an epipen and so, under normal circumstances, is a relative non-issue).

    Linking allergy to autoimmune disease.
    Valenta R, Mittermann I, Werfel T, Garn H, Renz H.

    Division of Immunopathology, Department of Pathophysiology, Center for Physiology and Pathophysiology, Medical University of Vienna, A-1090 Vienna, Austria. rudolf.valenta@meduniwien.ac.at
    Abstract

    Type I allergy is a classical Th2-driven hypersensitivity disease based on IgE recognition of environmental allergens. Exposure of allergic individuals to exogenous allergens leads to immediate type inflammation caused by degranulation of mast cells via IgE-allergen immune complexes and the release of inflammatory mediators, proteases and pro-inflammatory cytokines.

    However, allergic inflammation can occur and persist in the absence of exposure to exogenous allergens and might paradoxically resemble a Th1-mediated chronic inflammatory reaction.

    We summarize evidence supporting the view that autoimmune mechanisms might contribute to these processes.

    IgE recognition of autoantigens might augment allergic inflammation in the absence of exogenous allergen exposure. Moreover, autoantigens that activate Th1-immune responses could contribute to chronic inflammation in allergy, thus linking allergy to autoimmunity.

    J Neuroinflammation. 2011 Nov 30;8(1):168. [Epub ahead of print]

    Neuro-Inflammation, Blood-Brain Barrier, Seizures and Autism.

    Many children with Autism Spectrum Diseases (ASD) present with seizure activity, but the pathogenesis is not understood.

    Recent evidence indicates that neuro-inflammation could contribute to seizures. We hypothesize that and mast cell activation due to allergic, environmental and/or stress triggers could lead to focal disruption of the blood-brain barrier and neuro-inflammation, thus contributing to the development of seizures.

    Biochim Biophys Acta. 2010 Dec 28. [Epub ahead of print]

    Mast cell activation and autism.

    Molecular Immunopharmacology and Drug Discovery Laboratory, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine

    “Perinatal mast cell activation by infectious, stress-related, environmental or allergic triggers can lead to release of pro-inflammatory and neurotoxic molecules, thus contributing to brain inflammation and ASD pathogenesis, at least in a subgroup of ASD patients.

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