When “gut feelings” about science attack, or: Oh, no! Histidine and polysorbate-80 are going to destroy our girls!

Some people should keep their “gut feelings” to themselves.

You know the type: People who have no knowledge about a topic or, even worse, just enough knowledge to sound as if they have a clue about it to people who don’t have a clue but who are at the same time easily spotted as utterly and completely clueless by people who do have a clue. These people often think they’ve discovered something that scientists, in all their blindness have missed, and have a burning urge to share their “gut feeling” about what they think they have discovered as though it’s some revelation, a bolt out of the blue if you will. Not uncommonly, they also often “beg” the authorities, be they the CDC, FDA, NIH, or CIA (in the case of particularly wild clueless wonders) to take a look at their amazing new finding. Even more commonly, their “gut feeling” is based on cherry picking the scientific literature without understanding it and linking things that have no scientifically viable reason to be linked.

I’ve found an excellent example of a clueless wonder who’s done virtually all of the above. Meet Cynthia A. Janak, who describes herself as:

…a freelance journalist, mother of three, foster mother of one, grandmother of five, business owner, Chamber of Commerce member. Her expertise is as an administrative professional. Her specialties are adoptee and genealogy research and research journalism. Hobbies: Writing prose, crocheting, Conservative Studies, and rehabbing houses.

Sounds like a nice lady, right? I’m sure she’s also a perfectly competent administrative professional and house rehabber. Too bad this nice lady has written what has to be the most amazingly convoluted and silly attack on Gardasil I’ve ever seen. Unfortunately for her, being a nice grandmother isn’t enough to protect her from a bit of the ol’ not-so-Respectful Insolence, I’m afraid. It won’t be as heapin’ a helpin’ as usual, though. On second thought, the article she wrote, Polysorbate 80 and Histidine, a marriage of disaster, is just so mind-numbingly ridiculous that I’m afraid it does merit the full Orac treatment, Mrs. Janak’s probable niceness notwithstanding. (Sorry about that, Mrs. Janak.) I’ll probably feel a bit guilty when I’m done, but I’ll get over it. If someone’s going to post such amazing ignorance about science (while admitting over and over that she doesn’t know anything about the science) and expect to be taken seriously, she should be disabused of that expectation as quickly and unequivocally as possible.

First off, longtime readers may have noticed that I never really blogged much about Gardasil, the vaccine against human papilloma virus (HPV) designed to reduce the incidence of cervical cancer caused by certain strains of HPV, until very recently, when I noted two depressingly bad articles about this particular vaccine in Medscape, of all places. The reason I rarely blogged about Gardasil is because I’m not fully convinced that it is such an essential vaccine that it needed to be added to the recommended vaccine regimen so soon after its approval, given that it’s expensive and that its value is greatest among women who don’t get regular Pap tests–the very women least likely to get the vaccine. I don’t doubt that the vaccine is safe and effective; it’s just in the overall context of the vaccine program, I wasn’t sure why there is such an emphasis on this particular vaccine. Worse, I don’t like how some advocates of the vaccine are so quick to characterize people who bring up questions about Gardasil or the other anti-HPV vaccine as “anti-woman” or “misogynistic” (as I explained here). It’s definitely true that the fundamentalists of the religious right most opposed to this vaccine probably fit those descriptions, given that they think that the vaccine will somehow free women to be promiscuous by greatly–sorry, I can’t resist for reasons that you’ll see in a moment–attenuating one of the potential adverse consequences of sex, but there are reasons to question the rush to approve this vaccine without being a fundamentalist.

That being said, regardless of whether one’s an enthusiastic booster of the vaccine or someone like me, who thinks it’s safe and effective but not convinced yet that it provides a sufficient benefit relative to its cost that it needs to be an essential vaccine for every girl, the debate about Gardasil needs to be informed by good science, and pseudoscientific fearmongering does no one any good. Too bad that’s pretty much all that Mrs. Janak brings to the table, along with a heapin’ helpin’ of hot burnin’ stupid. She wastes no time, either, in bringing the stupid home right from the very first paragraph:

Do you know how it is when you have a gut feeling that just won’t quit? It is like the itch you just cannot scratch that gets worse with time. It is very annoying. Well, I was finally able to scratch that itch and all my efforts have finally paid off.

I have been researching Polysorbate 80 for some time now because I had a gut feeling that there is something to this chemical. I have been doing the same for Histidine because Gardasil is the first vaccine that is using this chemical. I knew that the addition of Histidine had something to do with what we are seeing with Gardasil. Here are my findings.

A little anti-histamine would help that itch. (Sorry, couldn’t resist again, for reasons you will soon see.) Too bad Mrs. Janak decided to do a belly flop right into a pool of histidine, at least metaphorically speaking. It’s also too bad that she clearly doesn’t understand the science. Indeed, she freely admits that she doesn’t understand the science, but keeps trying to make connections between studies anyway, with a statement like this:

Now, as I said earlier I am not a research scientist and I can only base my opinion on what I know but I found something of great importance that further proves the causative factor of the infusion of L-Histidine in this vaccine.

Or:

I read this whole study and it is hard to understand the procedures and the different tests that they conducted to come up with their conclusions.

Yeah, science at that level is hard. That’s why it takes so many years to learn. Yet Mrs. Janak seems to think that she can learn it just by perusing some PubMed abstracts, Wikipedia (yes, Wikipedia), and a few research articles made available online for free. Silly me. I spent all those years in medical and graduate school. Had I but known, I would have bypassed all that and been just like Mrs. Janak.

Before I go on, though, let’s point out just how much polysorbate-80 and L-histidine can be found in a dose of Gardasil: 50 μg and 0.78 mg, respectively. Keep those numbers in mind. Also keep in mind that the the WHO-recommended daily intake of histidine is on the order of 10 mg per kg body weight. For a typical 40 kg 13 year old girl, that would be 400 mg, or well over 500 times the amount that is in Gardasil.

Never mind that, though. Apparently such a small amount of histidine is a deadly threat to our girls. After a brief description of polysorbate-80, in which Mrs. Janak can’t seem to find too much to complain about, she proves that she has just enough knowledge to be dangerous–to reason, that is. But first she has much to make over the definition of a word:

What I want to bring to your attention is the fact that Polysorbate 80 is a surfactant. This is very important to remember.

[…]

My source also explained to me in layman’s language what all this means so I am going to impart that information to you. What this does is helps to suspend chemicals or materials evenly in the product that it is being used. In regards to a vaccine this helps to keep all the chemicals and virus like particles evenly distributed. This way one syringe will not have more chemicals and another will not have more virus like particles. You have more uniformity in the vaccine which is very important.

Fair enough. Mrs. Janak then goes not to the medical literature but to a website hawking supplements for her “definition” of histidine, most importantly this:

Most often recognized as a precursor to the allergy symptom producing hormone histamine, both histidine and histamine have essential roles in the body beyond tormenting allergy sufferers.

Histamine is well known for its role in stimulating the inflammatory response of skin and mucous membranes such as those found in the nose — this action is essential in the protection of these barriers during infection.

Histamine also stimulates the secretion of the digestive enzyme gastrin. Without adequate histamine production healthy digestion can become impaired. Without adequate L-histidine stores, the body cannot maintain adequate histamine levels.

Based on which she asserts:

The addition of L-histidine in the vaccine Gardasil I believe was a bad idea. Here are my thoughts. You have girls that are suffering after receiving this vaccine and some of the symptoms are nausea, vomiting and irritable bowel. Without adequate histamine production healthy digestion can become impaired. This is the first clue in the puzzle that is besieging these families and doctors that are trying to deal with this new epidemic.

That’s right. According to Mrs. Janak, less than one milligram of histidine is going to cause nausea, vomiting, and irritable bowel syndrome. Mrs. Janak needs to learn some units before she embarrasses herself by posting such burning stupid to the web. But she’s just getting warmed up. She fixates on an observation that histidine is involved in the regulation of of trace minerals and concludes that getting all that histidine (remember, 0.78 mg worth, to be precise!) must somehow mess up the body’s metabolism of heavy metals and cause heavy metal poisoning.

But Mrs. Janak’s still just getting warmed up. She goes on to discuss joint pain reported in VAERS as a sequela of vaccination with Gardasil and then finds a thirty-three year old article reporting low levels of histidine in patients with rheumatoid arthritis (RA). (No, there’s no evidence that Gardasil causes RA.) As is typical with such cranks, she neglects a more recent article (from 1981, anyway, only 27 years old!) that concludes that the low histidine levels detected in patients with RA are a consequence and not a cause of the disease, and that histidine levels provide zero prognostic value for predicting who is at risk for RA. Basically, from my reading of the literature, it’s a nonissue. Not that that stops Mrs. Janak:

So what is happening here? It is my opinion that low levels of histidine could be part of the overall problem that the girls are experiencing. Now my question to the medical research community is what could have caused this drop in histidine levels to cause all these problems?

I have my theory and that is that the immune response that was produced by the vaccine along with the infusion of histidine produced an unexpected reaction in all the girls that have a family history of allergies.

What happened is that because of this history it stands to reason that these girls already had a higher than normal level of histidine/histamine to begin with. Now we have just added more histidine into their systems therefore overloading and creating a dangerous situation. The immune system now has to deal with the dangerous levels of histidine along with the virus like particles and aluminum. Now we have a programmed immune response to the histidine and the immune system is going to attack it.

I love it when know-nothings like Mrs. Janak say “I have a theory.” When I see that phrase coming from such a woman, I know I’m entering what’s known in the skeptical blogging biz as a “target-rich environment.” Once again, we’re talking about 0.78 mg worth of histidine. Who knew it was so potent? Suffice it to say that Mrs. Janak’s understanding of immunology and pathophysiology is–shall we say?–underwhelming. But the pièce de résistance of stupid is yet to come. I know, I know, it’s hard to believe, but it’s true. Remember the title of her article, Polysorbate 80 and Histidine, a marriage of disaster. You know from that that we have to come back to polysorbate-80. Remember, it’s a surfactant, and leave it to Mrs. Janak to find an article that (she thinks) links surfactants and histidine to dire consequences, mainly blood clots, another alleged horrific complication of Gardasil. To this end, she demonstrates that she can’t even read. She takes an article entitled Surfactants Attenuate Gas Embolism-induced Thrombin Production. Remember the word “attenuate” and look at Mrs. Javak’s interpretation:

Now one of the things that we all know is that birth control pills can cause blood clots and anyone that is taking them should be aware of that fact. But were birth control pills the cause in some of the VAERS reports? I am no longer sure of that.

Now let us put this together with what I just gave you about surfactants and histamine you now have the possibility of a lethal, in my opinion, reaction of blood clots. According to the data that I have it proves to me that clotting does not necessarily happen because a girl is taking birth control pills during the time she received the Gardasil vaccination. This clotting has the real chance of happening because of the surfactant and histamine reaction in the body. Not because of the birth control.

I don’t even have to go into much detail to show just how silly this all is. Again, remember the word “attenuate” in the title. The entire point of the article, its main finding, is that surfactants attenuate thrombin production leading to clots. A-T-T-E-N-U-A-T-E. Look up the meaning of the word. It does not mean the same thing as the word “potentiate,” which is what Mrs. Janak seems to be claiming that surfactants do with respect to the action of histamine on inducing thrombin release. Indeed, the study concludes:

Thrombin production is shear rate and duration-dependent. Sparging increases thrombin production. Surfactants added before sparging attenuate thrombin production. Surfactants may have a clinical application to attenuate gas embolism-induced clotting.

In other words, the very point of the study was to investigate whether surfactants can decrease clot formation during gas embolism. Of course, what caught Mrs. Janak’s attention and made her thing this study had any relevance whatsoever to Gardasil is that one of the assays used to provoke thrombin production was to treat the blood with 10 μM histamine, apparently a standard assay to provoke thrombin release. Not having any idea of the units she’s dealing with, she has no clue that there’s no way in hell that treating a 40-70 kg teen with 0.78 mg of histidine is going to produce a 10 μM concentration of histamine–or anything within several orders of magnitude of a concentration adequate to provoke thrombin production and clotting.

But it doesn’t matter according to Mrs. Janak, because somehow, some way depletion of histidine also results in autoimmune encephalomyelitis. She bases this observation on a single animal study. Never mind that her “explanation” of how Gardasil might result in such a massive decrease in histidine is a load of scientifically ignorant rubbish. Never mind that she hasn’t clue one about how to read and understand the scientific papers she’s citing. Never mind that her interpretation of the previously mentioned gas embolism paper was exactly the opposite of what the paper actually concluded. Never mind that its results weren’t applicable to what Mrs. Janak was trying to prove anyway. It doesn’t matter, at least not to Mrs. Janak. Her article is one of the best examples I’ve ever seen of a little knowledge being a dangerous thing and the arrogance of ignorance. Indeed, that “knowledge” drives her to fits of concern:

Look at all this. I mean really look at this. We have the same symptoms that the girls are going through. How much more can I give to prove that we have the causative factor involved with this new epidemic we are experiencing with this vaccine.

Actually one hell of a lot more. Correlation does not necessarily equal causation, and in this case it almost certainly does not. Mrs. Janak’s ignorance of the basics of the field she purports to pontificate about is about as laughable as it gets, especially her self-righteous anger based on nothing more than ignorance:

I am begging the FDA, CDC and Merck to please please look at my findings. I am not a research scientist but I was the one to have to put the pieces of this epidemic together for you. Check out the dates of the studies that I have referenced. This information was available pre-licensure of Gardasil. Find out who was asleep at the switch to let all these findings be ignored.

Could it be because they didn’t have any relevance to the question of Gardasil’s safety or efficacy, perhaps? Not according to Mrs. Janak, who appears to view herself as a persecuted prophet:

Why did I have to be the one? Why were not these chemicals studied in a setting to see what they would do in a vaccine environment? WHY, WHY, WHY!!!!!!!!! We have girls dying and disabled and you are saying that there is no causative factor with Gardasil. Here it is! All the causation you need. Look into this immediately.

Oh, my dear God. I am sorry but I have to end this article here because I am next to tears and cannot go any further.

Mrs. Janak’s tears are our mercy, because they end our suffering far more effectively than taking the histidine and polysorbate-80 could relieve the suffering of all those girls in Mrs. Janak’s fevered imagination, but not before she writes:

NOTE: If I have made any mistakes because I am not a research scientist with what I have posted here today please feel free to let me know and I will check out your findings and post a retraction.

All I can say is that I’m happy to oblige. Not that I think that Mrs. Janak is capable of realizing just how hilariously, embarrassingly, over-the-top wrong she is about science, indeed about virtually everything she wrote in this particular article. In fact, her rant is about as excellent an example of how citing Wikipedia and studies that she can’t understand leads to a combination of hilarity and sorrow in those who actually have some training in science. For that purpose, it is very useful as a teaching tool. Yes, Mrs. Janak is proof positive that a little knowledge is more than just a dangerous thing. It’s the foundation of stupid so intense it’s painful to read. It’s also the way all too many anti-vaccinationists think.

I suppose I should just be grateful that Mrs. Janak didn’t discover the “polysorbate-80 causes infertility” nonsense that alarmists also like to rant about. Imagine how much more ignorance she could have polluted the Internet with if she were to find the study where this finding was reported. Given her difficulty with units in her first post, shed’ be almost certain to fail to realize that in this study neonatal rats were injected with 1 to 10 mg of polysorbate-80 (that’s 20 to 200 times the amount of polysorbate-80 in a single dose of Gardasil). Neonatal rats weigh approximately 5-8 g each and reach a weight of around 50 g by three weeks. Using the round number of 10 g for a rat that’s a few days old, we can see that, for a 40 kg teenager, the dose of polysorbate-80 used in this study was as much as 800,000 times greater than what a girl receives in a dose of Gardasil on a per-weight basis, 1 g/kg for the study versus 0.125 mg/kg for Gardasil.

My guess is that eventually she’ll find the study. I just hope she goes back and learns a little bit about the metric system and how to calculate doses before she does, although, given how often the Gardasil cranks cite the study above, it wouldn’t surprise me if she would believe that such a minuscule amount of polysorbate-80 is the deadliest of poisons, just as vaccine cranks mistakenly believe that the tiny amount of formaldehyde and aluminum are.