Deaths from vaccines in Japan?

Confusing correlation with causation. Post hoc ergo propter hoc. These are two of the most common errors human beings make. Indeed, they're natural errors that our brains appear hard-wired to make, and, without scientific training, it's virtually impossible to avoid making the conclusion that, because two occurrences correlate with each other they must be related or because and event precedes the onset of a condition (like autism), then that something must have caused that condition. One can see how, living in the wilderness, seeing patterns and causes quickly was likely to be beneficial more often than it was harmful, but in today's world, not so much. Worse, in coming to scientific conclusions, post hoc explanations and confusing correlation with causation, as natural as they feel and as convincing as they seem, all too often lead to leaping to conclusions that are utterly incorrect. The best example, of course, is the myth so prevalent in some segments of society that vaccines cause autism. Because we humans are so hard-wired to attribute cause to events that happen before an adverse event, all too often for parents who have come to believe it, belief in that myth is resistant to virtually all science. Indeed, even a few physicians who don't understand this normal human tendency and how science is the way to prevent it from leading us astray can become so passionately convinced that vaccines cause autism that they become in essence immune to science, evidence, and even reason. (Yes, I'm talking to you, Dr. Jay Gordon!)

Of course, it is not always straightforward to determine whether adverse events are due to vaccines or medications. This task it particularly complicated by how many children receive vaccines around the time the first symptoms of autism are most commonly noticed, making temporal association between vaccination and autism not uncommon strictly by pure coincidence. Sometimes, the events that seem to correlate with vaccines are much more serious than autism. Sometimes, it is the tragic death of a child or children that occur relatively soon after vaccination. In that case, figuring out whether the vaccine might have caused the deaths is absolutely essential, and it's not always a straightforward question. For instance, last week, there were four deaths in Japan potentially linked with vaccines that resulted in Japan's health ministry suspending the use of the vaccines pending an investigation:

Japan's health ministry suspended the use of pediatric vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA after reports of four deaths following immunizations.

The use of Pfizer's Prevenar, to protect children against meningitis and pneumonia, and Sanofi's ActHIB, to fight Haemophilus influenzae type b, will be suspended until at least tomorrow, when a safety panel will meet to discuss the cause of the deaths, the ministry said in a March 4 website posting.

The temporary suspension is a precautionary measure following the deaths of four children who had previously been immunized simultaneously with several pediatric vaccines, said Victor Carey, the Sydney-based Asia Pacific medical director for Sanofi's vaccines unit. About 1.5 million Japanese children have received ActHIB since it was approved in Japan in 2007, 15 years after it was first licensed in Europe, he said.

Whenever something like this happens, quite correctly the most compelling question is whether or not the vaccine has anything to do with these deaths. I searched and Googled, but I had a hell of a time finding any details about the four cases. How soon after vaccinations were the deaths? What did the children die of? The closest I could find was this report:

The ministry reported that three infants under the age of two died within three days of receiving the two vaccine shots, with two of the children also receiving DPT shots for diphtheria, whooping cough and tetanus.

A one year-old died a day after being administered Prevenar and a DPT shot, the ministry said, adding that some of the infants had underlying illnesses.

Prevenar and ActHIB became available in Japan around two years ago.

Authorities decided to suspend them after the four deaths occurred between March 2-4, the ministry said.

From these reports, it's difficult to tell if the vaccines might have had anything to do with the deaths of these four unfortunate children. A lot would depend on what the children died of. Did they die of anything that could be plausibly related to the vaccines? Or was there another, identifiable cause to which their deaths could be attributed? These reports don't say. Reasonable people would be concerned, but not leap to any conclusions. Not anti-vaccine loons like Mike Adams over at NaturalNews.com. He went into full mental jacket craziness not long after the reports:

The deaths just keep mounting all across the world: Children are collapsing into comas and then dying, just minutes after receiving combination vaccines that have been deceptively marketed as "completely safe." Last year, Australia temporarily banned flu vaccines in children after they were found to have caused vomiting, fevers and seizures (http://www.naturalnews.com/029586_A...).

Today the damage from vaccines is emerging in Japan, where the health ministry has suspended the use of vaccines from Pfizer and Sanofi-Aventis following the deaths of four children there who died within minutes after receiving these vaccine shots.

Except that, as the news report I cited above shows, the children did not die within minutes of receiving the shots. If they had, you can bet that they would not have been described as having died within three days or within a day of vaccination. It would also be far more concerning than deaths within a few days of vaccination, because closer temporal proximity would be more suggestive of the possibility of causation, particularly if the symptoms and timing were very similar in all the cases. But for Mike Adams, it's not enough just to say that four deaths are being investigated as possibly being related to vaccines. Oh, no. That's far too reasonable. Instead, he has to paint a false picture of children dropping dead from vaccines all over the world and (of course!) a worldwide coverup by big pharma to hide The Truth.

Adams does inadvertently do a service, though. Remember how I point out that post hoc reasoning or confusing correlation with causation is a common form of fallacious reasoning that leads to an evidence-proof belief that vaccines must have caused this problem? Adams actually spells it out explicitly in a manner more radical than I've ever seen before. In fact, he turns the whole concept of scientific investigation on its head, putting anecdote and post hoc fallacies above science:

How many coincidences does it take to make a pattern? If you're one of the brainwashed vaccine zealots, there is never a pattern. ALL deaths are automatically considered "coincidence," no matter how many occur or how frequently they appear. A true scientist, of course, would observe the pattern and realize there is a cause-and-effect phenomenon taking place. But then again, vaccine zealots are nothing like real scientists. They are propagandists.

Actually, if you're a brainwashed anti-vaccine zealot like Mike Adams, there is always a pattern. Always. There's a "pattern" even if it's only one child, even if the adverse event or death is separated temporally by days or weeks, and even if there is no evidence that the adverse event could possibly have been caused by vaccines. Heck, if a baby receives a vaccine and then is killed in a car accident as his parents drive home after the pediatrician visit, you can bet that Adams would try to blame it on vaccines somehow. Meanwhile, he lays down all sorts of straw mans, such as the claim that supporters of vaccination say that vaccines never hurt anyone, which is, of course, demonstrably untrue. Just read one of Dr. Offit's books, if you don't believe me.

The rest of the post is a typical Adams screed. He rants about big pharma conspiracies to cover up The Truth about vaccines, about how nutrition can supposedly protect against disease "better than any vaccine." (As important as nutrition is, it can't.) He even invokes Nobel Prize winner Luc Montagnier (who of late has become enamored of homeopathy, thus destroying his credibility on science) as saying that a strong immune system can cure AIDS. Never mind that HIV attacks the immune system. That's how it leads to death. If the immune system could stay strong against HIV, HIV would be a lot less dangerous. Heck Adams even invokes the true wingnut claim that Bill Gates was advocating using vaccines for population control when he pointed out that improved health care, including ready availability of vaccines, could lead to a decrease in population because people who don't have to worry about infant mortality tend to have fewer children. The main reason I cited this particular Adams brain turd is not so much because Adams fascinates me so much (although, truth be told, sometimes he does), but rather for that one paragraph above, which turns the scientific method on its head and elevates the human tendency to find patterns in observations even when there aren't any and to fall for post hoc ergo propter hoc as the default means of drawing conclusions about the world far above science. He even has the gall to lecture scientists on what a "real" scientist would do. And one wonders why my brain feels seared by burning stupid for having read that. Actually, one shouldn't. I feel as though I've lost some IQ points reading that screed.

I do, however, wonder what happened to the anti-vaccine crank blog Age of Autism on this one. As of my writing of this, there is nothing posted there about this story. Given that this sort of tragedy attracts anti-vaccine loons like Mike Adams as garbage attracts maggots, it is truly amazing that the merry band of anti-vaccine loons over at AoA haven't been all over this story already as proof that vaccines are irredeemably dangerous. It wouldn't surprise me if, by the time this post goes live, AoA has remedied that situation.

But I've beat on Mike Adams' less than stellar intellectual capacity enough for the moment. I'm sure he'll provide me with more blog fodder soon enough, and it's important not to go to the well too many times or, when at the well, to draw too deeply from it. Besides risking becoming boring, I also risk contamination with the neuron-apoptosing waves of stupidity that emanate from NaturalNews.com.

Instead, let's get back to the story. So what happened with that investigation. Japanese health authorities found no credible link between the vaccines and the four deaths. That leaves the question of whether or not Japan should have suspended the use of the suspected vaccines, and that was a tough call:

"I think the Japanese Ministry of Health was foolish to suspend the HIB and pneumococcal programs," says Paul Offit, a researcher at Children's Hospital in Philadelphia who co-invented a Merck vaccine used to combat rotavirus. "It was the wrong thing to do."

In all likelihood, Offit says, the four deaths are likely to be sudden infant death syndrome or another cause; he says two of the children had serious underlying health conditions. Any time a large number of people are given a vaccine, some of them will get sick and die just by chance.

While this is true, and it is most likely that these deaths appear to be a tragic coincidence, I find it difficult to be too critical of the Japanese authorities and their response. Very likely they were behind the proverbial rock and a hard place when news of these deaths was revealed. Very likely, political pressure was difficult to resist. Whatever the reason, the investigation appears to have found no link between the vaccines and these deaths.

Science is hard. It involves collecting data, testing hypotheses, and determining whether the data are consistent with the hypotheses, not to mention careful observation. More importantly, I like to think of science as a rigorous, elaborate system of observation and hypothesis testing in order to try to remove bias and keep the investigator from fooling himself. As physicist Richard Feynman once said so famously, "The first principle is that you must not fool yourself - and you are the easiest person to fool." The difference between anti-vaccine advocates and other boosters of pseudoscience and real scientists is that anti-vaccine activists forget this principle. In fact, they deny that they can be fooled.

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Japan's health ministry suspended the use of pediatric vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA after reports of four deaths following immunizations.

I wonder by how much the Japanese public's confidence in the Japanese vaccine program will be influenced by their government's willingness taking that action.

By Matthew Cline (not verified) on 08 Mar 2011 #permalink

So, you're damned in your do, damned if you don't - in this case, I agree with the actions of the authorities. They did what they needed to do & I'm sure most health organizations would have done the same thing.

Of course, vaccines will get smeared for this anyway - regardless of the real reasons these children died.

To answer Matthew, I live in Japan and I've already heard friends questioning whether they should take their kids for their next vaccines. Not good.

It would be far better if the media here focused on how painfully slow the government is on approving vaccines (I believe due to rules that all medicines need to be tested on ethnic Japanese before approval). A friend of a friend had a baby that caught rotavirus (can't get the vaccine here yet): http://blog.fujitv.co.jp/airmail/D20101007.html He took months to recover and is still lagging developmentally.

Re: Age of Autism

They had a couple tweets Monday saying how the vaccines' use was halted in Japan and how "America is LESS CAUTIOUS". So, they're not entirely leaving it be.

Shouldn't you let the Japanese authorities investigate further before YOU jump to conclusions? Or do you have compelling evidence that Japanese authorities are under the evil influence of Jenny McCarthy and Dr. Andrew Wakefield?

@Harold

Uh, did you actually read and comprehend what Orac wrote? Compare his "most likely" with the surety expressed by Adams. Also note that he does not fault the Japanese Ministry of Health for doing what they did.

Harold, re-read Orac's whole post - S-L-O-W-L-Y - this time for comprehension.

By Kausik Datta (not verified) on 09 Mar 2011 #permalink

@Harold L Doherty: there are these wonderful things called "hyperlinks" that come up in blue in Orac's post. If you click on these things, they take you to OTHER articles about this issue. And, one of the links:

found no credible link

states that Japanese officials have decided there was no direct link but that they would continue to do more checks.

Now, next time, please read everything in a post before quoting. You'll sound much more intelligent with your comments.

I agree with the actions of Japanese health officials also. I think that confidence in a vaccine programme is more easily recovered (relatively speaking) by applying the precautionary principle than if it had turned out the vaccines were responsible and precautionary action had not been taken.

Screeding that "vaccines kill infants" without a shred of proof is a win-win for the likes of Adams. He plays to his base and when vaccines are exonerated, he gets to claim "conspiracy theory" and plays to his base yet again.

I think that confidence in a vaccine programme is more easily recovered (relatively speaking) by applying the precautionary principle than if it had turned out the vaccines were responsible and precautionary action had not been taken.

Precisely.

To this modestly informed layman, the salient thing about this story is that the precautionary action was undertaken without the grandstanding of Warrior Moms or the caterwauling of foil-crowned conspiracists.

Even allowing for the possibility that the correlation in these four cases has some relevance to the underlying causation, the incidence has been brought to light and responded to without the slightest contribution of fear-mongerers with their Other Ways Of Knowing.

I'm surprised that this isn't all over AofA as well! I thought they would eat something like this up over there!! Not that they didn't give me a good dose of crazy over there, but I think they are slacking! ;)

By Anglachel the … (not verified) on 09 Mar 2011 #permalink

Suspending the vaccine is a procedure of Public Relations.

Another useful PR strategy is that of the United States. Instead of pretending to care about individual welfare with a precautionary principle. Put out media "education" through Associated Press sources about the imminent dangers of disease. Show how stopping the vaccine will murder countless lives. Far more than the 4 necessary casualties. Show how the vaccine is a necessary evil and the lives lost are worth it. Talk about benefit vs. risk.

This will also bolster confidence in the vaccine program. Allegiance to the program is paramount above all else. Attack anyone or anything that questions the vaccine or it's program. An attack on one is an attack on all.

None of that selective/delayed scheduling bs. It only shows a sign of weakness. Stomp it out.

By augustine (not verified) on 09 Mar 2011 #permalink

Auggie, two of the children had underlying serious medical conditions. How do you know those weren't the cause of death?

I agree that stopping until more was known about the deaths was a smart thing to do. Even if it happened to be some kind of rare allergic reaction to an ingredient, it would still be something to know beforehand to assess whatever risk was present.

By dedicated lurker (not verified) on 09 Mar 2011 #permalink

When a troll pretends to be reasonable, is it still a Poe?

I'm guessing that most people in the US have heard of the high school basketball player in Michigan who died minutes (or more like, seconds) after making the winning basket in a game.

I'm sure the doctors will claim that he had a serious underlying illness like a congenital heart problem, but shouldn't augie and the others blame making a winning basket? His death is far more connected to making the winning basket than are the vaccines, isn't it?

Of course I'll be archiving the first half of the first paragraph for later use if needed. Great post, as usual.

By DrWonderful (not verified) on 09 Mar 2011 #permalink

Let's not be so glum: truly the hard wiring is there, however is there not also *other* wiring that can over ride this tendency? Of course I'm talking about other human abilities that develop around the time of adolescence- what Piaget called "formal operations" and what others call "higher mental functions" or "executive function"- hypothetical thought, knowledge of combinational possibilities, taking the "view of the other", abstract thought, recursive thought, self-criticism, metaphor, evaluation, social applications, even sarcasm**. Science itself came from *somewhere* specifically human and based in physiology.

These abilities are found cross-culturally species-wide, although not all people achieve them ( you knew that *that* was coming) and can be encouraged in their development. Another job for us.

** according to Sb, we even know the precise locus from which it emanates . I mean *brain* location.

By Denice Walter (not verified) on 09 Mar 2011 #permalink

Science Mom

Oh you mean like what was done with thimerosal exposure back in 1999? Or these vaccine recalls? http://www.cdc.gov/vaccines/recs/recalls/default.htm

So you agreed with that strategy or did you oppose it for ulterior reasons?

And if you agreed did you agree for safety concern or to shut up the critics temporarily?

By augustine (not verified) on 09 Mar 2011 #permalink

@augie

Oooh! The false dichotomy game!

For myself, I agreed with the tack the gov't took wrt thimerosal because there was a legitimate scientific question and plausible safety concern. That question has since been answered.

Now, if you agreed, did you agree for rational, scientific reasons or from a knee-jerk belief that vaccines are the root of all evil and are meant to kill us all (ZOMG!!1eleventy!!)?

So you agreed with that strategy or did you oppose it for ulterior reasons? And if you agreed did you agree for safety concern or to shut up the critics temporarily?

So Auggie, have you stopped beating your wife yet or are you just waiting for the current bruises to heal?

Reply however you want and you'll still give me ammo to accuse you of something nefarious or say that you've now proved my point and proceed to gloat. You're not the only one familiar with the tactics of dishonest debate.

As for using the precautionary principle to approve any sort of medical treatment, how do you think medications or vaccines are approved? Without showing both reasonable safety and efficacy, pharmaceutical companies won't get an approval from government agencies and the list of medications which never actually made it to the shelves because the regulatory agencies found the side effects to be too dangerous or too extreme would fill volumes.

Oh wait a second... I forgot that you think all medication is approved by a sinister conspiracy to kill people just to get the to pay up for more toxins. Never mind.

IMO, Japanese authorities were "between a rock and a hard place" and it is better to err on the side of caution...to suspend the use of Prevnar until further investigation of the infants' deaths.

Orac, I don't think we will be hearing from Dr. Jay Gordon as on his website dated February 23, 2010 he comments regarding Prevnar, "too new for me to recommend." (In spite of the availability of the Prevnar 7 valent vaccine since February, 2000 and availability of Prevnar 13 valent vaccine since February, 2010).

On the RI blog "Now there's a skeptic movie I'd go to see", I questioned Dr. Gordon (March 8, 2011) about his statement that the vaccine was developed as prophylaxis for otitis media and rare incidence of strep. pneumoniae meningitis. He knows (or should know) that the Prevnar 7 and Prevnar 13 vaccines were developed to prevent incidence in infants of deadly invasive infections from strep. pnumoniae and that decreases in otitis media infections were a side benefit of the vaccines.

I also provided Dr. Gordon with the incidence rate in children < five years old (meningitis 700 cases and bacteremia 13,000 cases) of invasive strep. pneumoniae diseases before Prevnar 7 was developed (1998-1999). 13,700 cases of invasive diseases and their sequelae caused by strep pneumoniae in infants is not a small number and yet Dr. Gordon dismisses the vaccine and refuses to comment on it because it is "too new for me to recommend."

Statistics are also available comparing s. pneumoniae invasive diseases in infants (13,700) versus the incidence six years (2006) after the availability of Prevnar 7; decrease in incidence exceeding 95 %.

I wonder how long (in Dr. Jay's years) does a vaccine have to be available for him to comment on it or recommend it.

So you agreed with that strategy or did you oppose it for ulterior reasons?

And if you agreed did you agree for safety concern or to shut up the critics temporarily?

Poor Augie, just can't stand it when you are unable to criticise and too foolish to just shut your mouth, or sit on your hands as it were.

I agree with the precautionary principle enacted in the case of thimerosal for the very reason that Todd stipulated.

@lilady:

I wonder how long (in Dr. Jay's years) does a vaccine have to be available for him to comment on it or recommend it.

What is the maximum human lifespan? That long, plus one day. Just one day, you see, because Dr. Jay is Reasonabletm.

What is missing from the conversation is that the most likely scenario for these deaths to be vaccine-related would be if there was some sort of contamination or manufacturing flaw in a specific lot or lots.

The vaccines have too long of a track record for kids to have been dying at this rate with no one noticing.

In light of a possible contaminant, it makes lots of sense to suspend use. That gives the opportunity to check lot numbers, distribution sources, etc.

@Todd

That question has since been answered.

It has? Why hasn't the science blogging community kicked and screamed to have the mercury put back in then? Besides having cultishly low numbers for a grass roots campaign, are there any legitimate reasons not to put it back in?

@Fish

...how do you think medications or vaccines are approved?

Many are approved through the game of politics.

http://www.hopkinsmedicine.org/bin/m/b/meier.pdf

"Well, NFIP did form an advisory committee. And
they reformed it five or six times. Each time
somebody didnât agree, they dropped them and
got somebody who might agree. By the time they
were done forming the committee, everybody on it
was distinguished, but very agreeable.

The results seemed to be excellent, in favour
of the vaccine, and the NFIP asked the Advisory
Committee to say it approved the vaccine so that
vaccination could begin at once.

Albert Sabin MD, who was an NFIP supported
researcher, objected. He said that the report
itself had not been given to the Advisory Committee
in advance. He said that the Committee should
at least study the report and then they might
vote. âGive us time to read it,â he argued. The
NFIP gave them two hours. The NFIP was quite
powerful. They had anybody engaged in public
health, paediatric groups, all supporting the
vaccine. Almost everybody said it was an excellent
vaccine and it should be immediately released
for vaccine injections.
Then, two weeks later, the Cutter incident
broke."

"...But because there were so many improperly
diagnosed cases out there, and because the
other manufacturers went around to various
newspapers and threatened to cut their advertising,
it was dumped on Cutter. Cutter was responsible
because they did things in producing and testing
the vaccine they were told not to do. The
government also fired Workman, the head of
the NIH Bureau of Biologics, and he had nothing
to do with it."

http://www.sciencemag.org/content/125/3257/1067

"And why was the early evidence of unreliability in the inactivation process not publicly acknowledged until after the Cutter incident?"

By augustine (not verified) on 09 Mar 2011 #permalink

Manufacturers of all kinds do suffer hiccups in the production process - that's why we see car, food, child toy, drug, etc recalls on a fairly regular basis.

What this tells me is that the two-fold system works. First, regulations and inspections are in place to catch these issues at the front end & follow-ups are done on the backend, should a situation warrant, to get the offending products off the market & corrected as quickly as possible.

Just because a car is recalled doesn't mean we all stop driving - because a crib was recalled do we throw out all cribs, and if a drug is recalled, we don't scrap the entirety of modern medicine.

@augie

It has? Why hasn't the science blogging community kicked and screamed to have the mercury put back in then?

Because safe and effective vaccines without thimerosal have been developed. There is no current need in the U.S., though thimerosal can help keep costs to patients/insurance/docs down. Furthermore, the manufacturing process has been shifted to thimerosal-free production. Changing that back would cost a lot of money.

But then, if you actually stopped to think about things instead of opening your mouth and inserting your foot, you could've avoided looking a fool.

@Auggie,

Many are approved through the game of politics.

You know, if someone says...

Oh wait a second... I forgot that you think all medication is approved by a sinister conspiracy

... you don't go out of your way to prove his point for him and invoking a single incident as your proof, and at that, a case from the 1950s. Since you don't seem all that bright, let me do that math for you and note that it's been some 55 years since the Cutter Incident.

Pro-vaccines are like atrial fibrillation, they have multiple bursts of electricity in their atria.

They are always out of focus.

I was kind of thinking that the pro-science alliance was making headway. But maybe I am a Pollyanna, after all.

Political Online News

Yesterday we reported the news that 4 Japanese children died after receiving the vaccines made by Pfizer and Sanofi-Aventis drug manufacturers.

Today ABC is complicit in obscuring the truth about vaccinations and continued to mis-inform the public in a promotional news story where they endorsed the continuation of dangerous vaccines given to American children.

The main stream media networks were quick to silence the truth, obscure the facts, and continue promoting vaccines for their advertising sponsors. Today in the real media news networks are in the business of profits not reporting factual news.

Going around the local news here in Minnesota is the story that we've slipped quite a bit in vaccination rates. Refreshingly, all of the news stories have been balanced (not false balanced, but actually calmly reporting on the truth), and at the Star Tribune, when I last checked the story's comments were overwhelmingly sane, with lots of thumbs down to anti-vax commenters.

Interestingly, the decline in Minnesota is not being attributed only partly to anti-vax sentiments; lack of insurance is becoming a major factor in undervaccination as well now.

http://www.startribune.com/lifestyle/health/117586013.html

By Calli Arcale (not verified) on 09 Mar 2011 #permalink

Fish

Since you don't seem all that bright, let me do that math for you and note that it's been some 55 years since the Cutter Incident.

From your lack of argument, I take it that you agree that this is an example of scientific "politicking". And that your only argument is that it was 55 years ago and science has rid itself of politics or has risen to a level that doesn't involve politics anymore.

Unfortunately the two cannot be separated when governments are involved. Pure science does not determine health policy.

By augustine (not verified) on 09 Mar 2011 #permalink

ugh troll:

The reason a 55-year old incident is of no use is because it does not accurately describe the situation now.

Come up with some current evidence to back up your assertion.

You want to insinuate that things are the same today as 55 years ago, you provide the evidence. It's as simple as that.

Idiot.

@Liz Ditz

That site is so full of utter crap. @Vaccin8tionNews linked to a couple of their stories on twitter, which sucked me into an extended back-and-forth with her, explaining just what all is wrong. My head hurts, now.

It's also quite interesting to note that if you had to search 55 years of history to find a good example, it's pretty clearly not a common thing...

Pure science does not determine health policy.

No shit Sherlock - if it did the US would have a public health insurance system like every civilized industrial nation does.

For example:

Interestingly, the decline in Minnesota is not being attributed only partly to anti-vax sentiments; lack of insurance is becoming a major factor in undervaccination as well now.

Welcome to the third world.

By Militant Agnostic (not verified) on 09 Mar 2011 #permalink

compost 99

The reason a 55-year old incident is of no use is because it does not accurately describe the situation now.

Do you seriously think that politics and agendas play no role today in health policy? Seriously?

Come up with some current evidence to back up your assertion.

First tell me you're denying that politics play a role and then I'll make you look like a fool.

By augustine (not verified) on 09 Mar 2011 #permalink

You're the one making the claim. Put up or shut up.

That was a fantastic post. Very good summary of the issue and a great analysis of the usual responses.

I have a 14 month old who is smack in the middle of his immunisation schedule, and coming up due for a bunch of the vaccines you refer to in this post. Posts like these help me (and no doubt many others) make informed and reasoned choices about what to do about vaccinations.

I find reading books on the topics are the best way to get in-depth information on such matters, but these posts are so valuable because they up-date with the latest information, issues and controversies. So thank you.

You make a great point regarding Mike Adams, he has no direct knowledge of what happened and is using his speculation as a statement of fact to influence readers.

You may also want to critique Dr. Offit who has had a habit of doing the same, making an immediate diagnosis without any direct knowledge. Dr. Offit should have a press agency check his statements before they are made public, he's hurting as much as helping the cause at times.

http://blogs.forbes.com/matthewherper/2011/03/07/dont-be-frightened-by-…

In all likelihood, Offit says, the four deaths are likely to be sudden infant death syndrome or another cause.

Given his particular area of expertise, I certainly would put more weight behind Offit's opinion than Mike Adams'.

Of course, I also believe that final judgement should be reserved for when the evidence is in - nothing gets accomplished when one jumps to conclusions. That's a big difference between us & the trolls - we are actually willing to look at the evidence, while the trolls have already made up their minds (and are the only ones that know the "truth.")

That's a big difference between us & the trolls - we are actually willing to look at the evidence, while the trolls have already made up their minds

I guess you think Paul Offit belongs in with trolls. What evidence did he have access to before he made up his mind that vaccines were exonerated. He's already given an alibi. It must be SIDS. (like that settles anything)

I guess if someone gave him a folder with the "evidence" you'd conclude that he's being scientific about it. Because he's "looking at the evidence."The fact is he had already made his mind up.

By augustine (not verified) on 09 Mar 2011 #permalink

@SimonG: Thank you for the Forbes blog: I read it but don't agree that Dr. Offit is guilty of "making an immediate diagnosis without any direct knowledge".

Dr. Offit was asked his opinion and stated "In all likelihood,the four deaths were likely to be sudden infant death syndrome or another cause". The use of the words "likelihood" and "likely" in this short statement do not indicate that he has made diagnoses without knowledge of the causes of the deaths. And, other physician/specialists when asked their about the deaths in Japan, stated much the same thing.

Dr. Offit also mentioned in the Forbes blog that two of the infants had pre-existing conditions.

I have been "slumming" again at the Huffington Post and they have a totally unbiased article about the infants' deaths and the halting of the HIB and Prevnar vaccines' administration...until the investigations are complete. Postings on the site are "interesting"...

They should have asked a metereologist then for medical opinion.

We just had a little 7-month-old baby girl die in our county from Haemophilus Influenzae type A. She was vaccinated for HIB but I guess there's no vaccine for HIA. Does anyone know if the A type is becoming more invasive or virulent? Are they working on a vaccine for the type A serotype? Hopefully they are.

And then on the Prevnar vaccines...was Prevnar 7 replaced by Prevnar 13 because Prevnar 13 provides coverage for the 19A serotype which is now the most common invasive disease-causing serotype of pneumococcal disease and Prevnar 7 doesn't cover 19A? I know even Prevnar 13 doesn't cover all the serotypes for pneumococcal disease. Are they going to have a new Prevnar vaccine soon that provides coverage against all the serotypes? I think the one they use in Japan is the Prevnar 7. Is that right? I guess I never realized how complicated this all is.

@ CJF: HIB vaccine protects infants against invasive (meningitis, septicemia) diseases caused by the bacterium; there is no vaccine available for any other types.

The reporting from Japan indicates that the infants who died had a recent history of receiving the Prevnar 7 vaccine and HIB vaccine. Prevnar 13 does provide coverage for 6 additional serotypes including the 19 A serotype. It has been licensed for use in the United States since February, 2010. Recommendations for its use are to complete the infant series with the 13 valent vaccine and to provide a dose of it to children under 59 months of age who have certain risk factors.

The CDC Pink Book is available on the web, and has specific chapters on these two vaccines.

@Auggie,

Do you seriously think that politics and agendas play no role today in health policy? Seriously?

Take a look at something called the strawman argument. Seriously, you're arguing with random bullshit with which you come up, not what you're being told by others.

Well duh politics and agendas influence health policy but the point is that there is a precautionary principle in place when it comes to drug approvals and pharma co's have to show that what they're selling isn't actually lethal. The crap that AoA and anti-vaxers push, by contrast, is based on the idea of "hey, let's try it because why not?" rather than any safety studies of alternative modalities.

Fish

Take a look at something called the strawman argument.

It's a question. You're free to answer it.

when it comes to drug approvals and pharma co's have to show that what they're selling isn't actually lethal.

Isn't that what they do with every single drug or vaccine that's been approved?

I guess you never heard of Avandia or Vioxx.

By augustine (not verified) on 09 Mar 2011 #permalink

ugh troll @ 39:

Do you seriously think that politics and agendas play no role today in health policy? Seriously?

Kindly cite the comment number on this thread where I state such a thing. Otherwise you are, yet again, trying to wrestle with a straw man.

What I did state was that if it is your assertion that politics and agenda play roles in contemporary health policy, it is your responsibility to come up with contemporary evidence, not stuff from half a century ago.

ugh troll @ 51:

Citing examples where regulators successfully found problems with pharmaceuticals and had them removed from the market (or where manufacturers recalled them voluntarily) does not help your argument in this case. We're the ones saying that pre-licensure research & clinical trials and post-licensure surveillance are adequate to ensure medical products on the market do what they are supposed to do given the limitations of physiology, biochemistry, known adverse effects, etc.

Ask yourself this question: if Merck was not obliged to provide safety and efficacy information, in the form of rigorous clinical trials, of products like rofecoxib, and regulators were not obliged to engage in post-licensure surveillance for adverse effects, do you think Vioxx would still have been pulled? If so, why?

@Alan Kellogg

There are a range of possibilities. In some children, signs are noticeable, if not diagnosable, from the start. In other cases, people report normal progression with a sudden halt or even reversal of progress. Typically, any signs or symptoms are usually diagnosable by around 2-3 years of age. I don't think I've heard of autism signs first showing up after that approx. age, though one may go undiagnosed for quite a while if symptoms are mild enough.

That's my lay understanding of it.

@Auggie,

Isn't that what they do with every single drug or vaccine that's been approved? I guess you never heard of Avandia or Vioxx.

You mean the products for which ongoing safety data collection was required and which were pulled from the market by FDA edict after it was found that yes, a small number of people can develop fatal problems if they took this drug for many years?

Are you really that much of a dimwit to use cases of successful regulation which pulled unsafe medication off the shelves as soon as new safety data showed that it was not as safe as thought when approval was granted as an example of playing politics to sell toxic drugs to people, with the tacit approval of corrupt politicos? Do you also argue that fixing problems that led to plane crashes is a demonstration of the aviation industry's failure to make flying safer?

A good friend & autism care specialist starts looking for signs (ability to focus & keep eye contact are two big ones at age 0 - 6 months) with her kids right from the beginning. The severity of autism symptoms can vary wildly - so you can catch some very early on while others might not even be diagnosed until adulthood (though we are getting better).

@Alan Kellogg

It depends on what you are looking for. By one month of age, children who go on to develop ASD are more likely than typically-developing children to display subtle abnormalities such as asymmetric visual tracking asymmetry or upper extremity tone:

http://pediatrics.aappublications.org/cgi/reprint/peds.2009-2680v1

Of course, there is evidence that ASD develops even earlier than that, since subtle craniofacial dysmorphologies that develop during the first trimester are much more common in individuals with ASD (but with normal IQ) than in the general population, and identified environmental causes of ASD affect early fetal development.

I believe the group at the MIND Institute who are doing the prospective studies with siblings of autism and siblings of typically developing kids haven't found any differences in the first 6 months between the kids who are later diagnosed with autism and the kids who aren't. The first signs and symptoms emerge sometime after that six month period as some signs become apparent by 12 months.

The comparability of social behavior at 6 months of age in the ASD and TD groups replicates findings from other prospective studies.25,26,35 The lack of group differentiation at this age does not appear to result from low power, as the group means were very similar and effect sizes were very small. Most convincingly, the effects were in the opposite direction as predicted, with the ASD outcome group demonstrating (nonsignificantly) better social communication behavior at 6 months than the TD outcome group on all variables. After 6 months, the ASD group shows a rapid decline in eye contact, social smiling, and examiner-rated social responsiveness. Group differences were significant by 12 months in gaze to faces and social smiling and by 18 months on all other variables. Similar declining trajectories in the onset of autism symptoms have also been reported by others.35

--snip--

Collectively, the present investigation and recent prospective studies suggest that signs of autism emerge over the first year or so of life in many children with ASD, rather than being present from close to birth, as once suggested by Kanner.37 Although there are likely cases in which behavioral signs are indeed evident at or before 6 months of age, this pattern may be less common than originally thought.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923050/

Fish

Are you really that much of a dimwit to use cases of successful regulation which pulled unsafe medication off the shelves as soon as new safety data showed that it was not as safe as thought when approval was granted as an example of playing politics to sell toxic drugs to people

You're championing the Vioxx and Avandia screw ups as successful examples of regulation? You've got some balls.

Yes that is exactly what that did. It built swells of trust in the people running the system and in pharmaceutical companies.

By augustine (not verified) on 10 Mar 2011 #permalink

Ephedra, anyone?

@ CJF: Great comprehensive article about early identification of children on the autism spectrum. I believe I saw a short story on local TV...about a year or so ago, that provided some details about a "retrospective" study of children and adolescents who were later diagnosed with autism.

Specialists in the field of autism/autism diagnoses were provided with videos shot by parents of their children in their infancy..up to ages two or three. It was a large study; about 100 children who were later diagnosed with autism matched with 100 infants and toddlers whose development was normal. As I recall, the experts were able to identify close to 100 % of the infants/toddlers who were later diagnosed with autism and only misdiagnosed 2-3 children with autism...who had normal development. I am unable to locate any reference to this study; maybe you can find something on the internet.

When I visited "Autism Speaks" on the internet I found a reference to "ASD Video"; keying in that terminology I found a wealth of information about the "ASD Video". Apparently some parents of children with ASD volunteered videos of their youngsters for this video. I am in awe of the parents who offered the videos for this diagnostic tool for parents and specialists, so that children will receive early diagnoses and have appropriate services and interventions.

@58
"I believe the group at the MIND Institute who are doing the prospective studies with siblings of autism and siblings of typically developing kids haven't found any differences in the first 6 months between the kids who are later diagnosed with autism and the kids who aren't."

Yes, but the result depends on the test, doesn't it? That paper referred to studies of social behaviors. Neonates don't have a great range of social behaviors; the differences noted between infants at one and four months of age who do or do not develop autism are neurodevelopmental rather than social, and can be detected only if you actually look at such an early age--and, I think, that had never been done before.

BTW, even J.B. Handley of "Jenny McCarthy's Autism Organization - Generation Rescue", noted that his son's "chronic slide into autism" began well before six months of age: "The eczema and bad bowels came immediately after the 2 month visit . . . " Who knows, if J.B. had measured his son's upper extremity muscle tone or checked his asymmetric visual tracking, he might have noted that that "chronic slide" began even earlier.

Of course, Handley's claims mean nothing. The ony reason he nvokes the "after the 2 month appointment" crap is because the attempts to blame MMR after the 1 year appt have failed. Therefore, he has moved back to the 2 month appt in an attempt to blame DTaP. Personally, I don't believe any of it.

Hi brian -

Yes, but the result depends on the test, doesn't it?

Nice point.

I think that the CHARGE and MARBLES projects will be giving us good information on things like this in the next couple of years. There are already some biomarker studies along these lines; i.e., BDNF in cord blood, etc, IIRC. I believe this will be the death knell of autism living within the realm of the psychologists and the beginning of widespread recognition that autism is a medical disorder that manifests behaviorally. Good stuff.

- pD

According to no-fault-based medicine, there's no link.

From the previous link:

"The ministry said the unidentified boy, aged between six months and one year, died seven days after receiving Sanofi Pasteur's ActHIB in combination with a DPT shot for diphtheria, whooping cough and tetanus on February 15.

The latest case followed the ministry's earlier reports that five infants under three years old had died since early February after receiving the vaccinations alone or in combination with other drugs.

At least three of the six infants suffered from known pre-existing heart conditions and other illnesses."

By Dangerous Bacon (not verified) on 10 Mar 2011 #permalink

Pei pa koa is pretty decent cough medicine (from herbal as I remembered), great non alcoholic medicine, some western cough medicine are more effective, but this is non drowsy.

You can access info online @
en.wikipedia.org/wiki/Nin_Jiom_Pei_Pa_Koa
ninjiom.50webs.com

brian and pD and lilady,

Thanks for your help in understanding some of this. I've been googling around a little and came across a couple of studies published in the last couple of weeks. (I'll put them in two separate comments.) This one came out this week looking at copy number variation and how a lot of the copy number variants found in autism have something to do with the same processes in the brain. I guess many of them have something to do with glutamate and synapses in the brain.

Recent studies have implicated individual genes associated with synaptic function, including several neuroligands, as well as indications of glutamatergic pathway involvement.8, 13 Our current results extend these findings and, more importantly, for the first time provide statistical evidence that synaptic function and glutamate-mediated neurotransmission are contributing factors in autism etiology.

http://www.nature.com/mp/journal/vaop/ncurrent/full/mp201110a.html

In one sense, the finding was not what researchers had hoped for.

"There are dozens or hundreds of genes involved in autism. That makes studying the genetics of it more challenging," White told MyHealthNewsDaily. It also means it would be much more difficult to ever develop a genetic test for the disease, he said.

"But the good news is that many genes are involved in the same processes" â because that means treatments could be developed that focus on fixing those processes.

For example, the study showed a type of nerve signaling that relies on a chemical called glutamate may turn out to be more important than has been believed, so drugs that target glutamate signals may be one way to approach developing treatments for autism, White said.

http://www.myhealthnewsdaily.com/many-genes-behind-autism-do-similar-th…

I don't know anything about glutamate. Would this lend weight to autism being psychological or that it's more a medical disorder?

Here's the last paragraph of the discussion section of the second study that came out the end of last month.

Because MHCI molecules mediate the immune response46 and regulate cortical connectivity9, 14, as well as the balance of excitation and inhibition in the brain, it is possible that an abnormal systemic immune response during early cortical development could alter neuronal connectivity and change cognition by changing neuronal MHCI levels. This hypothesis is receiving increased attention as a result of mounting evidence for immune dysregulation in a number of neurodevelopmental disorders, including autism and schizophrenia41, 47, 48. Our findings are consistent with the idea that altering MHCI proteins during early cortical development could alter cortical connectivity and the balance of excitation and inhibition, pathologies characteristic of these disorders. To determine the relevance of our results to disease, it will be critical to define whether, how and when systemic immune dysregulation might alter neuronal MHCI to cause changes in cortical connectivity.

http://www.nature.com/neuro/journal/vaop/ncurrent/full/nn.2764.html#/re…

I think this is a press release on the study:

The number of connections between nerve cells in the brain can be regulated by an immune system molecule, according to a new study from UC Davis. The research, published Feb. 27 in the journal Nature Neuroscience, reveals a potential link between immunity, infectious disease and conditions such as schizophrenia or autism. Schizophrenia, autism and other disorders are associated with changes in connectivity in the brain, said Kimberley McAllister, associate professor in the Center for Neuroscience and Departments of Neurology and Neurobiology, Physiology and Behavior at UC Davis. Those changes affect the ability of the brain to process information correctly.

"Certain immune genes and immune dysregulation have also been associated with autism and schizophrenia, and the immune molecules that we study in brain development could be a pathway that contributes to that altered connectivity," McAllister said.

The study does not show a direct link between immune responses and autism, but rather reveals a molecular pathway through which a peripheral immune response or particular genetic profile could alter early brain development, McAllister said.

http://esciencenews.com/articles/2011/02/27/immune.molecule.regulates.b…

It looks like this has something to do with glutamatergic synapse density but I don't know enough to tell whether the two studies complement or contradict each other. Could one of you guys or anyone with some expertise weigh in?

Well, well. The Thing troll actually managed to post a link with a balanced view on vaccines. The article discusses the 6 deaths, that investigation into the deaths is ongoing, and that vaccinations are important to maintain health and should be continued. The end of the article actually voices a concern that people will stop vaccinating because of scaremongering (gee, is little augie in Japan?). I LOVE it.

Thanks, Thing. For once you gave us some GOOD information.

I've also never seen anyone gloat & take such delight in the death of children - the thing shows its true colors.

I wonder an advanced country such as Japan should use vaccines without proper control trial and ban the use of vaccine, which may be due to medication given simultaneously.

MI Dawn,

@75 Like you said,

The article discusses[...]

If you were to post an anti-vaccine article, would that make you an anti-vaccine too?(Hint: It's just news)