Flu vaccine lawsuit – a non-win, non-revelation regarding pregnant women

On 11 February 2019, Health Impact published an article about a flu vaccine lawsuit which an anti-vaccine group called the “Children’s Health Fund” described as a legal win and revelation. The claim was based on a response to a Freedom of Information Act (FOIA) request that did not, in fact, reveal any new information.

The flu vaccine lawsuit also did not counter the basis of expert agencies and organizations recommendations that pregnant women be vaccinated against influenza to protect themselves and their newborns. This article will review the facts of this action. Continue reading “Flu vaccine lawsuit – a non-win, non-revelation regarding pregnant women”

Sheep vaccine study – aluminum adjuvants alter their behavior

sheep vaccine study

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.

Citations

Richard Pan wins re-election despite Robert F Kennedy Jr anti-vaccine ad

Richard Pan

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.

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.

Of course, the anti-vaxxers are whining about Richard Pan and other pro-vaccine Democrats winning yesterday. I’m laughing. Although I wish the rest of Team Blue had done a bit better.

Children’s Health Defense anti-vaccine attack on Paul Offit – this again

Children's Health Defense

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”

Constitutionality of mandatory vaccinations – Robert F Kennedy Jr. is wrong

If you’re a regular reader of this blog or are just generally aware of current issues regarding vaccinations, you know that Governor Jerry Brown of California signed SB 277 into law. The law removes so-called “personal belief exemptions” for vaccinating children before they enter schools.

Personal belief exemptions were used (and frequently abused) by parents in California to exempt their children from vaccinations using religious beliefs (hardly any mainstream religion is opposed to vaccinations) or the “I don’t like vaccines” belief statement. So many California children were not fully vaccinated, especially when they were clustered in certain areas of the state, lead to several outbreaks of measles, whooping cough, and other infectious diseases.

Thus, the California Senate, led by Senator and Dr. Richard Pan, voted for SB 277, which sailed through the California Senate and Assembly, subsequently becoming law. Its sole purpose was to protect the children of California, the country’s most populous and wealthiest state, from ravages of diseases that were once on the verge of extinction.

Despite the overwhelming support from the legislature and citizens of the state, some groups remain steadfastly opposed. One trope being pushed is doubts about the constitutionality of mandatory vaccinations for children.

Even a group of lawyers wrote a letter to the California legislature, “Statement of Lawyers Opposed to California SB 277,” that tries to deny the constitutionality of mandatory vaccinations for children. The letter concludes:

…we strongly urge you to decline the temptation to tamper with California’s legislative scheme that works to achieve public health objectives while protecting the rights of individuals to make conscientious medical decisions regarding their own health.

Please take the responsible course by rejecting SB 277 and avoiding the legal, educational, and health decision-making chaos that would follow from enactment of this legislation.

The letter is signed by over 150 attorneys but appeared to be written by one Robert F. Kennedy, Jr, a famous attorney with a long history of playing “fast and loose” with the science regarding vaccines. Last month, this blog’s good friend, Dorit Rubinstein Reiss, who spends most of her time (as far as I can tell) writing about legal issues with vaccines, replied to Kennedy’s letter with real science, real constitutional law, and real facts.

Continue reading “Constitutionality of mandatory vaccinations – Robert F Kennedy Jr. is wrong”

Andrew Wakefield and Elle Macpherson – woo attracts woo while we laugh

Andrew Wakefield and Elle Macpherson

Celebrity romances rank with soccer, Game of Thrones, and iPhone vs. Android as the things I couldn’t care less about. I wouldn’t know anything about anyone. But, there are exceptions, like when the USA is actually in the World Cup. When I see stories about Andrew Wakefield and Elle Macpherson, I cannot stop myself. I have to read about it, and I have to make fun of it.

Now, most of us know all about one of the greatest scientific frauds of the past 100 years – Mr. Andrew Wakefield and his false, and ultimately retracted, claims that somehow the MMR vaccine was linked to autism spectrum disorder. Of course, there is a mountain of affirmative evidence that has refuted the claim of a link between the vaccine and autism. That’s settled science, except, of course, in the minds of Wakefield sycophants who believe otherwise.  Continue reading “Andrew Wakefield and Elle Macpherson – woo attracts woo while we laugh”

CDC Director Brenda Fitzgerald resigns – impacts on vaccines, public health

Brenda Fitzgerald

If I asked the general public about the CDC director, or who that person is (Brenda Fitzgerald), I’d get a blank look. It’s not exactly the most prestigious position in the Federal Government, but if you care about vaccines, cancer, infectious diseases, and public health, the Centers for Disease Control and Prevention is probably one of the more important Federal agencies, unless you buy into thoroughly debunked CDC whistleblower conspiracy theories.

Because most Donald Trump appointees to Federal government department and agencies were filled with incompetent, ethically-challenged, science-denying individuals, his appointment of Brenda Fitzgerald as CDC Director was, more or less, taken by the science and medical community with a sigh of relief. She wasn’t anti-vaccine. She seemed to understand the role of public health in the USA. And she was a doctor. Trump could have done much worse, as we’ve seen in other departments.

The anti-vaccine religion has been bigly supportive of Trump because he had shown some proclivity towards the vaccine denier beliefs. But they ended up crying vaccine tears when Trump did the “right thing” (probably the only time I will write that comment with respect to Trump) regarding several public health posts, including the CDC Director and Surgeon General.

Then it all blew up.

Continue reading “CDC Director Brenda Fitzgerald resigns – impacts on vaccines, public health”

RFK Jr and vaccine safety – using a bad study to come to bad conclusions

RFK Jr and vaccine safety

Yesterday, Dorit Rubinstein Reiss explained why most experienced journalists ignore Robert F. Kennedy Jr’s views on vaccines. He gets simple facts about vaccines completely wrong again and again. She was referencing an interview Kennedy had given on Fox News – as a part of that interview, Kennedy misused a small study about the DTaP vaccine (for diphtheria, tetanus and pertussis, or whooping cough). Unfortunately, RFK Jr and vaccine safety of DTaP has continued – he has doubled down on misusing this study in an article by him published today.

I thought we would take a look at the issues specific to this new version of RFK Jr and vaccine safety – we’ll analyze his comments and then take a detailed look at the published article that forms the basis of Kennedy’s comments. Continue reading “RFK Jr and vaccine safety – using a bad study to come to bad conclusions”

RFK Jr vaccine beliefs – why experienced journalists don’t take him seriously

rfk jr vaccine tucker carlson

On April 20, 2017, Tucker Carlson from Fox News interviewed Robert F. Kennedy  Jr. on his show, and they talked about vaccines. Mr. Kennedy pointed out that this is only his second interview on the topic in ten years, and blamed it on advertising dollars (which, apparently, did not prevent Mr. Carlson from hosting him). So why are RFK Jr vaccine beliefs ignored by the mainstream press?

The reality, however, is that journalists familiar with Mr. Kennedy’s past utterances on vaccines avoid him is because of his history of saying things that are blatantly wrong, and journalists who give him credence may well end up with egg on their face. This interview is a good example.

Robert F. Kennedy Jr. is an environmental lawyer. Best as I can tell he started speaking on vaccines in 2005, with an embarrassingly wrong article posted on both Salon and Rolling Stone that claimed that the CDC was engaged in a conspiracy to hide the fact that the vaccine preservative thimerosal was linked to autism.

After five corrections of the blatant errors in Kennedy’s article, Salon also retracted it, explaining that critics’ exposure of further problems “further eroded any faith we had in the story’s value. We’ve grown to believe the best reader service is to delete the piece entirely.”

Kennedy has repeated the same grossly inaccurate statements – claiming a conspiracy to hide the fact that thimerosal in vaccines causes autism – since, and has not recanted, most recently publishing a book making the claim ironically named “Thimerosal: Let the Science Speak,” and also pushing a challenge to science supporters on the topic, following in the footsteps of holocaust deniers, climate change deniers, anti-vaccine activists, evolution deniers, and others.

In the intervening years studies from all around the world looked at thimerosal in vaccines and did not find a link between it and autism. More recently see publications here and here. The global nature of these studies means that even if the CDC wanted to conspire to hide a link, it wouldn’t be able to, not without controlling the rest of the world. No serious scientific source today really thinks that the tiny amounts of thimerosal in vaccines (and as a reminder, all childhood vaccines, with the exception of multi-dose influenza, contain no, or almost no, thimerosal) causes autism or other neuropsychological problems – or any other serious, long-term harms. But Kennedy does. Because conspiracy.

RFK Jr vaccine statements are hostile, and also very, very extreme.  In a famous quote, he said:

They can put anything they want in that vaccine and they have no accountability for it,[…] They get the shot, that night they have a fever of a hundred and three, they go to sleep, and three months later their brain is gone…This is a holocaust, what this is doing to our country.

Not only is this untrue, but it’s highly offensive to children with autism to say their brain is gone, as is the comparison to the holocaust. Unsurprisingly, science supporters were dismayed by Kennedy’s claims – denied by the Trump transition team – that President Trump offered him the position of leading a vaccine commission.

 

Continue reading “RFK Jr vaccine beliefs – why experienced journalists don’t take him seriously”

Vaccines cause autism debate – it only exists in the minds of vaccine deniers

vaccines cause autism debate

In an op-ed piece in the Washington Post last month, New England pediatrician Daniel Summers effectively wrote that the so-called vaccines cause autism debate was over. He wrote, “not merely one study or two, but study after study after study confirms that vaccines are safe, and that there is no connection with autism.” In fact, there are 100s of studies, many of them with a huge number of data points, that have shown no correlation, let alone causation, between vaccines and autism. None.

Other than stating that I objectively support Dr. Summers’ statements and conclusions, I don’t have much else to say. But you and I know that an op-ed piece by a real doctor will be noticed by someone in the vaccine denier world, and they will pull out every single trope, myth, and conspiracy theory to claim that Dr. Summers is wrong and that there really is a “vaccines cause autism debate.”

I came across an article by Jeremy R Hammond in the right wing alternative news website, Personal Liberty, which attacked Dr. Summers with those aforementioned tropes, myths, and conspiracy theories. The same ones you’d see from any of your standard, run-of-the-mill vaccine denier.

Let’s take a look at Hammond’s article. Generally, I can only get through about half of an anti-vaccine article when I have to stop because I’m banging my head against the desk too much. I need to protect the neurons in my brain from further damage. But I will try to persevere in the name of science.

Continue reading “Vaccines cause autism debate – it only exists in the minds of vaccine deniers”