A few weeks ago I wrote an article about Emma Mhic Mhathúna was a 37-year-old Irish mother of five who died in October 2018 from cervical cancer – an easily diagnosed and treated cancer if discovered early. She died because of a pap smear scandal in Ireland that led her to receive a false negative on her two pap smear tests in 2016. As a result of this scandal, HPV vaccine uptake has increased for preventing cervical cancer. Continue reading “Preventing cervical cancer – HPV vaccine uptake increases in Ireland”
The claims for acupuncture have any clinical usefulness are vastly overblown with evidence ranging from weak to nonexistent to dangerous. As Steven Novella at Science-Based Medicine once wrote, acupuncture is nothing more than “theatrical placebo.” On the long list of ridiculous claims for this pseudoscience is using acupuncture for hypertension treatment – and once again, real biomedical science shows it is worthless.
And now, it’s time to examine a systematic review that debunks the false claim that acupuncture for hypertension is useful. Continue reading “Acupuncture for hypertension – more evidence that it does not work”
A while ago, I wrote an article about a father who is suing the New York Department of Education to force a school to allow his unvaccinated son into school. The basis of his lawsuit is that vaccination is against his religious beliefs. How does this lawsuit fit into our ideas about religion and vaccinations?
The father is a Roman Catholic and claimed that his church was opposed to vaccines. As far as I could find, the Catholic Church strongly supports vaccination, even making it a moral and ethical issue by clearly stating that “there would seem to be no proper grounds for refusing immunization against dangerous contagious diseases…”
The Catholic Church even advises for vaccinations in those vaccines manufactured using permanent cell lines that derive from aborted fetuses. In other words, not only is the Catholic Church not opposed to vaccination, it seems to indicate that it would immoral to not vaccinate.
This all leads me to wonder if there was research into the relationship between religion and vaccinations. And I found some.
We call them zombie vaccine tropes, beliefs of the anti-vaccine world that keep reinventing themselves and come back alive, despite being dismembered by skeptics and scientists all of the world. One of the most annoying zombie tropes has been the MTHFR gene and vaccines – the trope states that it’s dangerous to vaccinate a child with the MTHFR gene mutation, which really isn’t supported by scientific evidence.
I never know what causes trope to start, and why it returns from the dead, but MTHFR gene and vaccines seem to be one of them. Let’s take a look at the MTHFR gene, and why there might be an issue with vaccines.
In 2014, I reported on an outbreak of a mysterious viral disease that exhibited polio-like symptoms. At the time, around 23 children and young adults were afflicted with this polio-like syndrome, known as acute flaccid myelitis. Since then, a total of around 350 individuals have been stricken by the acute flaccid myelitis from 2014 through 2018.
Recent reports of another outbreak of acute flaccid myelitis in Minnesota has brought out zombie memes pushed by the anti-vaccine religion, they blame acute flaccid myelitis on the polio vaccine. Of course, these bogus claims aren’t based on any scientific evidence, but that’s never stopped the anti-vaccine zealots.
These outbreaks have caused the public health sleuths to search for the actual causes of this polio-like syndrome. And there just isn’t any robust or valid evidence that the polio vaccine is any way related to acute flaccid myelitis.
As we know, polio can be a crippling and potentially deadly infectious disease caused by the poliovirus, a human enterovirus, that spreads from person to person invading the brain and spinal cord and causing paralysis. Because polio has no cure, the polio vaccine is the best way to protect ourselves from the crippling disease.
The United States last experienced a polio epidemic in the 1950s, prior to the introduction of the polio vaccine 60 years ago. Today, polio has been eradicated from most of the planet, as the number of worldwide polio cases has fallen from an estimated 350,000 in 1988 to 113 in 2017 – a decline of more than 99% in reported cases.
Because real scientists wanted to know what caused this acute flaccid myelitis outbreak, they tried to hunt down the actual cause. And that’s when they landed on enterovirus 68, a once-rare virus. As we always do, we’ll look at the facts behind this virus and it’s relationship to polio (or polio vaccines).
Over the past 20 years or so, I’ve read a lot of vaccine research studies. Most, published in top journals by real scientists, are worthy of respect. And they provide powerful evidence that vaccines are safe and effective. Of course, there are a handful of studies that are pseudoscientific garbage. Or retracted. But today, I think I’ve seen it all – a Spanish animal research team published a sheep vaccine study that they claim shows that the aluminum adjuvants in the vaccine altered their behavior. And you just know that the anti-vaccine religion will jump all over it as “proof” that vaccines are dangerous. Yawn.
In case you missed it, yes, this is a sheep vaccine study.
To be fair, I have no idea whether these researchers are part of the anti-vaccine religion – it’s possible that they think they’ve found something, but they do rely upon some discredited anti-vaccine tropes and falsehoods as the premise of their studies. Moreover, this article furthers the false narrative about aluminum in vaccines. And we’ll keep seeing it repeated on anti-vaccine Twitter and Facebook posts because the anti-vaccine zealots have nothing else.
The sheep vaccine study by Javier Asìn et al., published in Pharmacological Research, investigated cognitive and behavioral changes in lambs that had received repeated vaccination with aluminum-containing vaccines.
Let’s take a critical look.
Sheep vaccine study results
I’m not going to spend much time with the results, because I find it very troubling that the author’s conclusions are based on a total study of 21 animals, seven in each group. I laugh at clinical trials in humans that don’t contain 1,000 or more patients or epidemiological studies that don’t include a sample population over 100,000. An animal study that includes 21 lambs ranks near at the bottom half of the hierarchy of biomedical research.
The researchers put those 21 sheep into three equal groups:
A. Control group
B. Adjuvant only group
C. Vaccine with adjuvant group
I will get to a criticism below, but based on the small experiment, the authors concluded that:
Animals in groups B and C exhibited behavioral changes: affiliative interactions were significantly reduced and aggressive interactions and stereotypies increased significantly. They also exhibited a significant increase in excitatory behavior and compulsive eating. In general, changes were more pronounced in the Vaccine group than they were in the Adjuvant-only group. Some changes were already significant in summer, after seven inoculations only. This study is the first to describe behavioral changes in sheep after having received repetitive injections of Al-containing products, explaining some of the clinical signs observed in ovine ASIA syndrome.
Aluminum in vaccines
For those of you who are unfamiliar with aluminum in vaccines, aluminum adjuvants are added to vaccines to stimulate the immune response to the vaccine’s antigen – however, they do not induce any immunity to anything by themselves.
Aluminum adjuvants have been used for over 70 years in vaccines without any evidence that they cause harm. Unfortunately, these adjuvants have only become an issue for the anti-vaccine world because they keep running out of real science to support their beliefs about the safety of vaccines.
There are a few key points to be made about aluminum adjuvants:
- The amount of aluminum in vaccines (and remember, only a few vaccines have aluminum) is measured in micrograms. The maximum allowable amount of aluminum in a vaccine is 125 µg. Based on the recommended schedule of vaccines, the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4225 µg (or 4.225 mg). Let’s put this into context – a newborn baby averages body burden of about 384 µg of aluminum. In addition, typical concentrations of aluminum in breast milk (10-49 µg/L), soy-based infant formula (460-930 µg/L), and milk-based infant formula (58-150 µg/L) mean that the dose of aluminum from these sources far exceed the dose of vaccines in just a few weeks. A baby also inhales several thousand micrograms of aluminum per day, unless they live in some bubble with ultra-pure air.
- As I constantly mention, the dose makes the poison. And these doses of environmental and vaccine aluminum are far below the minimum risk level for the body burden of aluminum.
- Only if you assume that the body cannot clear aluminum (usually only in the case of kidney failure), the cumulative dose of the metal doesn’t actually matter.
- There is a trope, pushed by the anti-vaccine world, that somehow injecting aluminum is much different than consuming or inhaling it. This is simply not based on any science known to the biomedical world. The kidneys filter out most of the aluminum salts way before it accumulates. Furthermore, inhaled and ingested aluminum occurs every single day unless your baby doesn’t eat or breathe, whereas the tiny dose of injected aluminum occurs infrequently.
There simply is no robust, peer-reviewed evidence that the amount of aluminum salts in vaccines are in any way harmful. But that never stops the anti-vaccine religion from making unfounded claims.
ASIA, not the continent
Asin et al. start out their paper by stating that autoimmune syndrome induced by adjuvants (ASIA) is an adverse reaction of vaccines. ASIA is a belief, pushed by Israeli immunologist Yehuda Shoenfeld, that certain autoimmune conditions are caused by aluminum adjuvants in vaccines.
However, ASIA has been thoroughly dismissed by most scientists and regulatory agencies. Numerous large case-control and cohort studies, both near the top of the hierarchy of biomedical research, have found no evidence of a relationship between vaccines, especially the HPV vaccine, and ASIA. For example, researchers looked at nearly 300,000 vaccinated and unvaccinated women (reviewed here) and found no link to ASIA. There are many more studies that show a similar lack of causal links.
Thus, before we even start critiquing this paper, the authors start with a bogus hypothesis that is unsupported by real scientific investigations. Unless, of course, you subscribe to anti-vaccine lies, memes, and tropes. Then you probably are a true believer.
Sheep vaccine study critique
Despite the fact that the paper has a couple of discredited claims, about aluminum and ASIA, there are other significant issues with the paper. Let’s review:
- The researchers only looked at a total of 21 sheep in 3 groups. Important clinical and epidemiological studies have thousands or even millions of data points. It is difficult, if not impossible, to determine a causal link with such a tiny sample size.
- The animals in the two experimental groups, one vaccinated with the typical vaccines given to sheep and the other with just aluminum adjuvant. The animals received 16 vaccine doses within 12 months for a total of 70.861 mg of aluminum. These are the number of doses that a sheep receive over 6-7 years! Furthermore, if you’re prone to comparing sheep to humans, that’s 20X more aluminum adjuvant than a human receives over a year – of course, human infants are smaller. Nevertheless, even though I dismiss any link between injected aluminum and neurological issues, giving 6-7 years of vaccines over 12 months biases the results. In addition, I’m skeptical of the behavioral observations, but it is possible that the serum aluminum levels are so high that it exceeds the safe limit for aluminum.
- The study was not randomized or blinded (or they failed to mention it in the methods section). You might think that randomization on matters with humans, but the researchers could have biased the results by the way they treated the sheep.
- This study relied upon subjective observations of the sheep’s “behavior” post-vaccination. These are the type of issues that hinder many behavioral and neurological studies – a subjective analysis of change in behavior is almost impossible to quantify. And when there are just 21 animals, it’s almost impossible.
- Sheep are social animals and the process of vaccination itself, especially so many over a short period of time, may induce behavioral changes irrespective of any contents of the vaccine, although the control group did receive a placebo injection.
- This sheep vaccine study is a primary research article – that means it lacks any supporting data anywhere else. It’s like the old vaccines cause autism canard – one retracted study supported it. On the other hand, literally hundreds of clinical and epidemiological studies along with meta-reviews have debunked that claimed link. That’s why most real biomedical researchers ignore primary animal studies – they pique interest, but rarely form the foundations of science-based medicine. Since we have dozens of studies that show no behavioral changes post vaccination, how much does a very small, very poorly designed sheep study tell us? Next to nothing.
- In a 2013 study by the same research group, they observed that around 0.5-1.0 % of animals of a flock exhibit the type of behavioral symptoms, irrespective of vaccination, described in the newer paper – yet they conveniently ignore it. Given the tiny sample size, the lack of randomization or blinding, and other issues, it’s impossible to tell if this is background noise.
I’m done here
The anti-vaccine religion has pounced on this study, which doesn’t surprise me or any other pro-science person out there. Dr. Bob Sears (the California pediatrician on probation for some issues about vaccine exemptions) and the crackpot science denier Robert F Kennedy Jr have tried to abuse this pathetic study to further their pro-disease for children beliefs.
This sheep vaccine study barely rises to the level of bad evidence – it provides us with nothing useful about the discussion regarding aluminum in vaccines. Moreover, there is overwhelming evidence, as shown in so many powerful peer-reviewed studies, that there simply is no link between aluminum adjuvants and anything.
Why do the anti-vaccine use this terrible sheep vaccine study to support their claims? Because they’ve got nothing else. Nada. Squat. Zilch.
- Asín J, Pascual-Alonso M, Pinczowski P, Gimeno M, Pérez M, Muniesa A, de Pablo L, de Blas I, Lacasta D, Fernández A, de Andrés D, María G, Reina R, Luján L. Cognition and behavior in sheep repetitively inoculated with aluminum adjuvant-containing vaccines or aluminum adjuvant only. Pharmacol Res. 2018 Nov 2. pii: S1043-6618(18)31373-2. doi: 10.1016/j.phrs.2018.10.019. [Epub ahead of print] PubMed PMID: 30395948.
- Liu EY, Smith LM, Ellis AK, Whitaker H, Law B, Kwong JC, Farrington P, Lévesque LE. Quadrivalent human papillomavirus vaccination in girls and the risk of autoimmune disorders: the Ontario Grade 8 HPV Vaccine Cohort Study. CMAJ. 2018 May 28;190(21):E648-E655. doi: 10.1503/cmaj.170871. PubMed PMID: 29807937; PubMed Central PMCID: PMC5973886.
- Luján L, Pérez M, Salazar E, Álvarez N, Gimeno M, Pinczowski P, Irusta S, Santamaría J, Insausti N, Cortés Y, Figueras L, Cuartielles I, Vila M, Fantova E, Chapullé JL. Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA syndrome) in commercial sheep. Immunol Res. 2013 Jul;56(2-3):317-24. doi: 10.1007/s12026-013-8404-0. PubMed PMID: 23579772.
- Perricone C, Colafrancesco S, Mazor RD, Soriano A, Agmon-Levin N, Shoenfeld Y. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: Unveiling the pathogenic, clinical and diagnostic aspects. J Autoimmun. 2013 Dec;47:1-16. doi: 10.1016/j.jaut.2013.10.004. Epub 2013 Nov 13. Review. PubMed PMID: 24238833.
On 5 October 2018, the FDA expanded the licensing Gardasil 9 – currently the only HPV vaccine marketed in the United States – to men and women up to the age of 45. If up till now getting the adult HPV vaccine was not a realistic option for me, now it was. But at this point, the vaccine is not yet recommended for my age group – the Advisory Committee on Immunization Practices has not made any additional recommendations after licensing. Which raised the question: should I get it?
On one hand, I am in a committed monogamous relationship. I am a married mother of two young children, I have no plans of changing partners, and I’ve already probably been exposed to anything my husband had. I have never had an abnormal pap smear. That means that I am likely pretty low risk for getting a new HPV infection and that I have cleared any I ever had (almost all sexually active people in the United States have had HPV). If you are in a relationship, including marriage, and if you had children, you likely had sex at some point.
So the benefits of the adult HPV vaccine for me are low – but not non-existent. You never know what will happen, and while I hope to stay with my partner forever, bad things can happen – like death or sexual assault. One hopes for the best, but it’s reasonable to also plan for the worst (for example, while we do not plan to die, we have a will written out with provisions for caring for our kids if we do) – and the vaccine is age-limited. There are nine cancer-causing HPV strains in the vaccine, and I am fairly certain that I have not been exposed to all of them.
The risks of the adult HPV vaccine are extremely minor. I’m likely to get a sore arm, may get other mild reaction like fever, and have a theoretical reaction of an allergic reaction (or fainting, though not being a teen, I think that’s unlikely). Studies pretty much rule out other risks.
In spite of anti-vaccine claims, getting the vaccine after being exposed to HPV does not increase your risk of cancer (but the vaccine won’t protect you against strains you were already exposed to).
So the adult HPV vaccine has low benefits but minuscule risks, at least for me. Still, it seemed to me to make sense to go for it, if possible. Especially because I speak up about HPV vaccines and encourage others to go for them, I thought it’s fair to get them myself, too. Show I mean it when I say that they are safe.
To be sure, I emailed Dr. Paul Offit, who I trust completely on vaccines. He recommended going for it.
I did not know, however, if my provider will give me the vaccine or if my healthcare insurance will cover it at my age (most health insurance in the USA does cover all vaccines, including the HPV vaccine, for children). In spite of what anti-vaccine people believe, I do not have secret ties to pharma or special access to vaccines.
So I emailed my doctor:
Dear Dr. X,
Since the FDA approved HPV vaccines for people up to 45, I would like to get the vaccine, if possible.
I emailed Dr. Paul Offit, a vaccine expert, for his opinion, and he recommended getting it.
Can you help me do that?
My doctor said: “Sure, let me see what our protocol is here and get back to you.”
After I did not hear back for over a week, I emailed again. My doctor answered:
Sorry that I could not repond in a timely manner.
I had forwarded your request to Dr. Y [details omitted to preserve my providers’ – and my own – privacy] but did not hear from them. I have ordered the shots. You can call your … health plan to see if it will be covered just to be sure.
You can go to ### injection clinic Mon-Fri 9am-12pm, 1:30-4:30 pm for the shot (ordered already).
Okay. All that was left was to actually get the vaccine. I wanted a picture – so I asked my eight-year-old son if he will act as photographer and come with me. He agreed. We went together, waited, and went in. I told him to take a lot of pictures all through, and he did.
The nurse asked if I was feeling okay, if I ever had a reaction to a vaccine, if I was allergic to latex or anything else I knew of (yes, no, no). She explained what the shot was, and gave me the Vaccine Information Statement. We also wrote out the schedule for the next two doses. Then she cleaned the area, told me to take a deep breath and let it out, and done. I barely felt the needle.
She told me my arm will hurt for a day or two. It didn’t, actually. Not complaining. I’m okay with less pain. But I would have been okay (not happy, but okay) with a sore arm for a few days, too.
My son did a great job taking a lot of pictures. I posted several of those pictures on Facebook and Twitter, because, again, I think it’s important to make it clear I stand behind what I say on HPV vaccines specifically, and vaccines generally.
So that’s my adult HPV vaccine story. One dose down, two to go. Maybe my arm will hurt next time.
For those living under a rock ( about which, I’d have to ask “why?”), the USA had its so-called mid-term elections, which are state and Federal elections that happen at the halfway point of the US President’s term. Unfortunately, instead of the blue wave, we got more of a blue ripple, where the Democrats barely won the House, with positive and negative results for Team Blue across the country. In California, there was one state Senate election that was interesting to many of us, the re-election of Richard Pan who is a staunch supporter of vaccines.
Dr. Pan is not only a pediatrician but also is a Democrat who represents the 6th Senate District, located in Sacramento, CA. For those you who don’t follow California politics, Dr. Pan was the prime sponsor of SB277, which eliminated the abused personal belief exemptions for vaccines. The law essentially mandated vaccines for children entering school, and it has greatly increased vaccine uptake for school-aged children in California.
SB277 still allowed for medical exemptions, which are exemptions that are medically necessary such as allergies or immune disorders. Unfortunately, the anti-vaccine crowd has abused this “loophole” by buying, in many cases, medical exemptions from unscrupulous individuals.
Dr. (or is it Senator) Richard Pan has been targeted by the anti-vaccine crowd many times for his support of mandatory vaccination. They have even resorted to vile and disgusting racist attacks against him. It has even reached a level of violent hate speech that seems to be common in US politics these days.
But Richard Pan has stood his ground on vaccine mandates, and he continues to be a strong proponent of children’s health issues. And that includes vaccines.
— Dr. Richard Pan (@DrPanMD) November 6, 2018
Just prior to the election, Robert F Kennedy Jr, a science-denying and anti-vaccine nutjob Democrat In Name Only, decided to attack Richard Pan in a very expensive advertisement which ran in the Sacramento area. RFK Jr has gone off the deep end lately, not only running this ad against a fellow liberal Democrat but also attacking the integrity and ethics of one of the most respected physicians in medical research. Kennedy subscribes to pseudoscience and false information about vaccines to further his agenda. And let’s not forget, he genuflected to Donald Trump in a lame attempt to create a vaccine safety commission.
Yeah, I think RFK Jr is a black mark on the Kennedy name.
Well, none of this nonsense mattered in the election. Richard Pan won his California State Senate seat 68-32% over an anti-vaccine independent, Eric Frame. Admittedly, Senate District 6 is overwhelmingly Democratic – Hillary Clinton won the district by about the same amount over Donald Trump in 2016.
Richard Pan wasn’t the only pro-vaccine candidate that mattered, but as a California citizen who thinks that protecting young children from vaccine-preventable diseases is a critical healthcare issue, I felt that the re-election of Dr. Pan was a great thing for the state.
Congratulations to Richard Pan. I hope he goes far in California politics (if we’re lucky, there may be a US Senate position open in California in 2020, hint hint).
And to Robert F Kennedy Jr. – you’re a science denier and traitor to progressive politics. You’re in bed with Republicans which include in their membership avowed science deniers and vaccine haters, Donald Trump and Rand Paul. Kindly remove your cranium from your colon. Please.
The supplement industry is huge and unregulated. Americans spend more than $30 billion annually on them, yet contaminated supplements are part of the industry’s method to make their mostly useless products appear to have some clinical effect.
There is growing evidence that these contaminated supplements contain unlabeled ingredients that are found in regulated pharmaceuticals – all without telling the consumer about them. Or testing them. Or listing warnings for their use.
As I’ve written many times, supplements are basically worthless, unless you have specific chronic medical conditions or suffer from chronic malnutrition that prevents you from receiving enough micronutrients, like vitamins and minerals. In addition, those on highly restrictive diets, like vegans or those who have had weight-loss surgery, may require supplementation, although both could be considered “chronic medical conditions.”
For example, in modern prenatal care, the pregnant mother is urged to take folic acid supplements to reduce the risk of neural tube defects in the developing fetus. But after the pregnancy is over, folic acid is no longer needed – in fact, continued use of folic acid may actually increase the risk of some forms of cancer, in individuals who have no medical need for the supplement.
Because a lot of people favor confirmation bias as their go-to argument, I constantly hear, “hey Skeptical Raptor, vitamin C prevents scurvy, ergo all supplements are the greatest thing we can consume.” Scurvy is fairly rare these days in developed countries, but it can happen especially to smokers since cigarette smoke inhibits uptake of vitamin C (and another reason not to smoke).
So unless your diet only includes steak, ice cream, and junk food, an average American or European will get more than adequate amounts of vitamin C from their diet. Anyone deficient in vitamin C could be considered to be malnourished, and, of course, they will benefit from a vitamin C supplement. But vitamin C does not prevent colds, flu, or cancer. It is not a miracle vitamin, despite the oft-debunked claims of the pseudoscience-based supplement proponents.
Despite the utter lack of or weak evidence of the usefulness of supplements, unsurprisingly, over half of all Americans take dietary supplements. I guess chronic malnutrition and medical conditions afflict over half of Americans. The facts are that human needs for nutrients, like vitamins, are more than adequately met by a broad, healthy diet that includes a lot of fruits and vegetables.
But there’s more bad news, and it’s more than just overpriced, mostly useless products. It’s that contaminated supplements are widespread in this industry. Continue reading “Contaminated supplements – spiked with potentially dangerous ingredients”
Maybe you don’t know much about Children’s Health Defense, but it’s a newer anti-vaccine group run by Robert F. Kennedy Jr., who has become one of the high priests of the anti-vaccine religion. RFK Jr., scion of the Kennedy family who dominated US politics for decades, has gone off the deep end of conspiracies from the assassinations of his father, Robert F. Kennedy, and uncle, John F. Kennedy, to the discredited belief that vaccines cause autism.
Children’s Health Defense, as a proxy for RFK Jr.’s lunatic beliefs about vaccines, decided to utilize ad hominem attacks on Dr. Paul Offit as part of their offensive against vaccines. Why? Because the anti-vaccine crackpots lack any evidence of any of their claims, so the best they can do is attack people with childish name-calling and logical fallacies. If this wasn’t about saving children’s lives with safe and effective vaccines, I’d just laugh at these people. They are ridiculous members of a lunatic fringe.
Although I’m not going to waste your time tearing apart each absurd attack they make on Dr. Offit, I’ll tackle a few. For educational purposes only! Continue reading “Children’s Health Defense anti-vaccine attack on Paul Offit – this again”