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Autism Omnibus: Snyder appeal denied

12 Aug

The appeals for the MMR phase of the Omnibus are now concluded: all three were denied.

The Autism Omnibus Proceeding is the way the “Vaccine Court” has taken on the task of deciding the merit of the theory that autism is a vaccine injury. The petitioners had two basic theories: (a) the MMR vaccine can cause autism and (b) the vaccine preservative thimerosal can cause autism.

Three hearings were heard for each theory. In each hearing a single individual took the role of a “test case”. So, each hearing not only represented the case of a single child, but also presented “general causation” evidence as to whether MMR or thimerosal could cause autism.

The six test cases (three MMR and three thimerosal) have been heard. The MMR cases were ruled upon, and all three were denied. All three were appealed. And, now, all three appeals have been denied.

Here is the conclusion of the appeal for the last of the MMR test cases, that of Colten Snyder:

As the special master’s decision makes clear, Colten, and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitioners’ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitioners’ motion for review. Pursuant to Vaccine Rule 30(a), the clerk is directed to enter judgment in accordance with this decision.

Very solid decision. The appeal was denied.

Looking back through the document one finds that the Judge noted that the case for MMR causing an injury was clearly not supported, and that the Special Master did not make an error in her decision:

The court finds no error in the special master’s findings. The special master’s conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitioners’ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. See id. at *87-93 (petitioners’ theory),
116-35 (Unigenetics’ reliability). Next, the special master’s conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record.

In a statement reminiscent of the Cedillo hearing (first MMR test case) the Judge noted that the medical records show that the “onset of symptoms” did not occur when the petitioners thought:

She [the special master] found that based on the medical records, the onset of Colten’s symptoms did not occur at the time suggested by petitioners.

It is worth reading or skimming the decision. It is a good summary of the case and the evidence presented. I don’t want to quote much more of the document here, with this exception.

Petitioners’ charge–that the special master feared a public backlash against vaccines if she ruled in their favor–is preposterous. There is not a shred of evidence to support petitioners’ claim;70 it rests solely on petitioners’ speculation. Merely because the special master found that petitioners did not carry their burden of proof does not diminish her integrity or render her decision unsupported. Claims of error by a losing party against a decision maker are hardly unusual, but should be grounded in reality.

One thing that bothered me greatly was the implication in the appeals that the Special Masters were acting improperly out of some hidden motive such as trying to protect the vaccine program or fear of public backlash. Sometimes it is difficult for a lay person like myself to understand whether such arguments are expected and “just part of the game” or whether they are attempts to impugn the integrity of the Special Master. I have read enough comments on other blogs to see that many readers are willing to accept that members of the judiciary could act to deny children due process.

I’m glad the Judge in this appeal took the time to respond to these false allegations.

Autism Omnibus: Hazelhurst appeal denied

29 Jul

The Autism Omnibus Proceedings is, for better or worse, one of the big stories in the world of autism news. Hearings have been held, using the best science and arguments that could be brought to bear. The two theories were (1) does MMR cause autism and (2) does thimerosal cause autism.

Each theory was tested using three “test cases”. Essentially, three trials for each theory, each discussing an individual child plus arguments on “general causation”.

So far, the decisions are only in on the MMR question
. The answers were clear and decisive: “this is not a close case”.

The Omnibus decisions are not the end of the vaccine/autism lawsuits. Not by a longshot. The first step was an appeal, and the first appeal has been decided.

Here is the conclusion of the Judge who heard the appeal for the Hazelhurst case:

In hearing this appeal, the court is not without sympathy for Yates, the Hazlehursts, and the other children and families dealing with autism and autism spectrum disorders. And this court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is AFFIRMED.

I.e. the appeal failed. The decision stands. The Court holds that MMR does not cause autism.

The judge’s decision in the appeal gives a good summary of the original case. If you want to read about the Hazelhurst case, it would be the first place I would send you.

From the appeals judge’s ruling, here are the two “cardinal” flaws in the petitioner’s case:

1) First, the special master explained that petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus rather than on the characteristics of vaccine-strain measles, despite the fact that the measles vaccine is distinguishable from the wild-type measles virus in several key respects.

2) Second, the special master observed that petitioners’ experts further based their opinions on studies (detecting the presence of the measles virus in the gut tissue of autistic children) that the special master found to be unreliable.

The special master considered the presence of the measles virus in the gut to be the “linchpin” of the petitioner’s case. In other words, they needed to show reliable data or studies demonstrating that the virus was still in the tissues of the children long after the vaccination.
The two studies they had to rely on were (a) that by Dr. Wakefield’s team and (b) an unpublished study by Dr. Stephen Walker, presented as a poster at the 2006 IMFAR conference. Well, the Wakefield study was pretty well discredited, and the Walker study was never published.

In the appeal, the Hazelhurst’s lawyer argued that the testimony of Dr. Stephen Bustin should not have been considered. Amongst the arguments were that some of the information was submitted at the last minute.

No arguments were made that Dr. Bustin was wrong in his analysis of the O’Leary laboratory. That was one of those strange moments in law–no one challenged Dr. Bustin on being right. The judge hearing the appeal noted that the rules for the Vaccine Court are different from a typical court of law. Specifially, the rules are designed specifically to allow more information in to inform the Special Master. The judge further noted that under the typical rules of evidence, the Walker study would never be admitted anyway.

If you haven’t read about Dr. Bustin’s testimony, you should consider it now. Dr. Bustin basically discredited the entire “persistent measles in the gut” idea by showing that the O’Leary laboratory that made tests had serious methodological flaws and, basically, couldn’t make the tests at all.

The Hazelhurst’s lawyer then argued that the Special Master failed to include all the relevant evidence., In specific, that the Walker study wasn’t given due weight.

Again, one of those strange moments in law. The laywers moved directly from trying to get the Special Master to exclude evidence that was clearly relevant, to claiming that the Special Master had to include all relevant evidence. I guess that’s why I am not a lawyer. I couldn’t pull that off with a straight face.

As it turns out, even the witness for the Hazelhurts’ side stated that the Walker study wasn’t reliable:

Respondent additionally notes that Dr. Hepner herself acknowledged that the preliminary data from the study was “not useful at this time” (Cedillo Tr. at 682), declined to draw any conclusions about the biological significance of the Walker group’s findings (Cedillo Tr. at 682), and identified what respondent describes as several significant drawbacks to the study, including that the experiments had not been “blinded”28 and had lacked negative controls.

So, it is rather moot as to whether the Walker study was considered, since it doesn’t really provide substantial evidence to support the MMR theory.

The third main argument used in the appeal was that the Special Master failed to decide on a “critical issue”. Namely, whether regressive autism exists as a separate phenotype.

The Special Master wrote in his decision, and the appeals judge agreed: since the decision held that MMR doesn’t cause autism, there was no point in deciding on the question of regressive autism as a separate phenotype.

Given that the expert testimony was against this idea, it is probably better for the petetioners that this question was left unanswered.

The main result is, of course, the original decision was upheld. Looking forward, it doesn’t look good for the MMR theory to win in civil litigation from my perspective. The Bustin testimony is very damning to the little evidence there is, and that will be allowed in a civil case. The Walker study, however, will almost certainly not be allowed as it is unpublished and has severe limitation

Autism and Gastrointestinal symptoms: two new studies

28 Jul

Autism and poop. You hear those two words in the same sentence a lot on the net. People have been asking for studies on whether autistics have a higher incidence of gastrointestinal (GI) problems for a long time. Well, two papers came out in the last week with answers…and many parents are not happy.

The two papers are:


The early stool patterns of young children with autistic spectrum disorder

by B Sandhu, C Steer, J Golding, A Emond of the University of Bristol

and

Incidence of Gastrointestinal Symptoms in Children With Autism: A
Population-Based Study

by Samar H. Ibrahim of the Mayo Clinic.

The Bristol group’s study came out last week. Given that the Mayo Clinic study was on the way, I figured I’d wait and blog them both at the same time. Actually, I considered not blogging them at all. These papers are more nails in the coffin for Andrew Wakefield’s hypothesis that MMR causes “autistic enterocolitis” and the belief by many that this drove much of the “autism epidemic”. But, tired as that story is, the question of whether autistics have GI problems at a higher rate is important and worth discussing.

The Bristol study has free pdf access. Not so the Mayo Clinic study: abstract only, but I have a copy. Rather than go through the studies in detail (if you are that interested you will likely read the paper for yourself), let’s just look at the results and conclusions sections of the abstracts:

Bristol group:

Results: Comparison of the ASD and control group during the first 3.5 years of life showed no major differences in stool colour or consistency, or in frequency of diarrhoea, constipation, bloody stools or abdominal pain. The ASD children had similar stool frequency up to 18 months, but there was a trend for ASD children to pass more stools at 30 months (OR 3.73, 95% CI 1.11 to 12.6; p=0.004) and at 42 months (OR 6.46, 95% CI 1.83 to 22.7; p,0.001), although only three children passed more than 4 stools/day. Repeating the analysis on only those cases diagnosed as having classical childhood autism resulted in very similar findings.

Conclusions: During the first 42 months of life, ASD children had a stool pattern that was very similar to that of other children, apart from a slight increase in stool frequency at 30 and 42 months. There were no symptoms to support the hypothesis that ASD children had enterocolitis.

Mayo Clinic:

RESULTS: Subjects were followed to median ages of 18.2 (case subjects) and 18.7 (control subjects) years. Significant differences between autism case and control subjects were identified in the cumulative incidence of constipation (33.9% vs 17.6%) and feeding issues/food selectivity (24.5% vs 16.1). No significant associations were found between autism case status and overall incidence of gastrointestinal symptoms or any other gastrointestinal symptom category.

CONCLUSIONS: As constipation and feeding issues/food selectivity often have a behavioral etiology, data suggest that a neurobehavioral rather than a primary organic gastrointestinal etiology may account for the higher incidence of these gastrointestinal symptoms in children with autism.

Or, to put in a single sentence: there is no evidence that children with autism have GI problems at a greater rate than the general public.

How about repeating that with emphasis: there is no evidence that children with autism have GI problems at a greater rate than the general public. They are not saying that there are no children with autism and GI issues. Quite the contrary. You wouldn’t know that to read some comments on the internet about these studies.

I’m a little surprised by these results. No, I don’t think that Wakefield was right. But, I wouldn’t be surprised if children with autism have other medical concerns at higher rates. Also, there were two abstracts from IMFAR 2008 that stuck in the back of my mind.

In the first, a team from the University of Connecticut presented a study suggesting that GI issues may be more common in children with children with ASD’s (but at a similar rate to children with other developmental delays).

No evidence for higher rates of gastrointestinal problems in young children with ASDs versus those with other developmental delays

Conclusions: In this sample of young community-based children with ASDs and other developmental delays, no significant group differences in parentally reported feeding problems and gastrointestinal symptoms were found at age two or at age four. Most published research has been conducted at specialty GI or DD/ASD clinics with older children. The results of this study suggest that their findings may not be applicable to young children or to children evaluated in community settings. While GI problems may be increased in children with developmental disorders, we found no evidence that they were specific to autism spectrum disorders.

The second abstract (which later became a paper that was discussed on this blog): David Mandell’s group presented a paper suggesting that a significant fraction of adults hospitalized with schizophrenia diagnoses might actually have autism:

Evidence of autism in a psychiatrically hospitalized sample

Their IMFAR presentation (and later published paper) showed an increased number of GI problems in their adult group. 36% of their adults had GI problems vs. 23% of the general psychiatric hospital population.

Unfortunately, these latest studies are getting the usual “online-autism-parents” community welcome. It follows the same pattern as vaccine/autism research:

a) Ask for studies to be done
b) Studies are done
c) Disagree with the data
d) try to slime the authors

Is it a surprise to anyone that some researchers have opted out of working on autism?

(note: minor edits were made shortly after publishing this article)

Brian Deer talks back to Andrew Wakefield

7 Jul

I was copied in to the following:

Date: Mon, 06 Jul 2009 18:12:00 +0100
To: “Joanna Bower”
From: Brian Deer
Cc: Thoughtful House

Ms Joanne Bower,
RadcliffesLeBrasseur LLP

Dear Ms Bower,

Your client, Dr Andrew Wakefield, has published, and caused to be published, on his website, thoughtfulhouse.org, and on other sites, false claims that the Press Complaints Commission has issued an “interim order” concerning my investigation into his conduct. Dr Wakefield claims that The Sunday Times has been ordered by the PCC to remove my stories about him from its website.

I understand that the PCC has written to your client to point out that these claims are untrue. In fact, all of my stories concerning him are available at the Times Online website.

thoughtfulhouse.org is unquestionably controlled by Dr Wakefield, and his publication there has caused similar untruths to be published on websites either directly controlled for his interests, such as cryshame.org, which, as you may know was set up by Mrs Isabella Thomas, the parent of two of the children anonymised in the now-infamous Lancet MMR paper, or indirectly controlled for his interests, such as ageofautism.com, operated to promote and profit from concern over children’s vaccines.

It is, of course, nothing new for Dr Wakefield to mislead the public, and especially the parents of autistic children. He has faced the longest ever proceedings before a General Medical Council fitness to practise panel, following the GMC’s reinvestigation of my journalism. In due course, I’d expect he will face a hearing of the PCC, covering much of the same ground on a significantly different evidential base.

However, you may feel it advisable to explain to your client that either he accepts the untruth of his latest claims and takes them down, or he maintains them in publication, in which case his conduct would not merely be wrong, but would be dishonest.

With best wishes,

Brian Deer

http://briandeer.com

Wakefield’s false claims backfire

6 Jul

Last week Andrew Wakefield announced to the world that the Press Complaints Commission (PCC) had ordered the Sunday Times to take down some articles about him from its website. Wakefield suggested that this was a tacit admission by the Times that its story was inaccurate and this message was dutifully repeated by Age of Autism and the rest of Wakefield’s online supporters.

As I reported previously, the PCC is waiting on the final outcome of the GMC disciplinary hearing against Wakefield before conducting its own inquiry over the articles and felt it would be fairer all round if the material was temporarily removed from the Times website. The Times agreed and removed the articles as a courtesy to the PCC. The Times was not impressed by Wakefield’s ungracious response and as a result the material is now back on their website.

This is not the first time that Wakefield’s actions have backfired on him. Four years ago he tried to sue Channel 4 and Brian Deer for libel over a documentary, MMR: What they didn’t tell you, that contained damaging revelations about Wakefield’s role in the MMR scare. As with his current complaint to the PCC and his recent press release, Wakefield’s action in bringing the case seems to have been motivated by a desire to please his loyal supporters rather than a serious attempt to settle the issue. Unusually for a litigant, Wakefield showed a marked reluctance to clear his name in court, seeking to delay the hearings for two years. When the court decided that Deer and his legal team were entitled to see the unredacted medical records of the children who were the subjects of Wakefield’s original Lancet paper Wakefield withdrew the action and agreed to pay costs to Brian Deer.

It is ironic that without the libel action by Wakefield it is unlikely that Deer would have been granted access to the medical records. And without the records he would not have sat through months of the GMC and so written the story that Wakefield is now complaining about.

According to Brian Deer (private communication, quoted with permission)

There’s also the irony that it was Wakefield who in February 2004 called for a GMC investigation into my allegations that he had a conflict of interest over his research for lawyers, and no proper ethical cover, prompting me to hand over all my materials to the GMC’s lawyers, producing the longest doctor’s discplinary hearing ever.

I understand that the Press Complaints Commission has written to Dr Wakefield about the claims on his website, and he’s now in a tricky position. Either he admits that was he says is untrue, and takes down his claims, or he leaves them up in circumstances which would then be both dishonest and actionable.

I expect Wakefield to withdraw his complaint to the PCC once the GMC deliver their verdict. He will claim that it is impossible for him to get a fair hearing in the UK. It may suit him to continue to play the martyr from his self-imposed exile in America while enjoying the adulation that befits a “brave maverick doctor.” But he is and will remain the author of his own misfortune.

Wakefield, distortion and the Sunday Times

3 Jul

The journalist Brian Deer has done as much as anyone to investigate the background to what Ben Goldacre describes as the MMR Hoax. In the course of his investigations he discovered undisclosed conflicts of interest by Andrew Wakefield that led to most of the authors of the original paper in the Lancet withdrawing their names and the editor publishing a retraction.

Then in February this year Deer published his latest investigation. The Lancet paper had already been dismissed as bad science. Now, if Deer’s findings were correct, it would seem that some of the data had been deliberately falsified. Wakefield responded by complaining about the article to the Press Complaints Commission. The Times stood by its story and also forwarded all details to the General Medical Council who are still investigating Wakefield over allegations of misconduct.

And that was it until this week, when Thoughtful House, the clinic that Wakefield has established in Texas, issued a press release announcing

Press Complaints Commission Orders Sunday Times to Remove MMR journalist’s Stories on Dr. Wakefield from Paper’s Web Site

It goes on to suggest that this “interim order”

appears to indicate there are questions about the accuracy of the Deer stories.

Of course it does no such thing. Thoughtful House even quote Stephen Abell of the PCC as saying that

Given the ongoing nature of the dispute the articles should be removed from the newspaper’s website until this matter has been concluded. This would not be an admission of any liability on the part of the newspaper.

The wording reveals what actually happened. The Sunday Times has not been ordered to take down the articles. The PCC decided to postpone its investigation until after the GMC reaches a decision on the allegations of misconduct. This makes sense. If Wakefield is found guilty the complaint will fail. Meanwhile the PCC has asked the Sunday Times to remove the article from its website until matters can be resolved and the Sunday Times has agreed. That tallies with the email I received from the PCC

The PCC has considered the matter initially and has elected to stay its investigation until the conclusion of the GMC inquiry. It has reached no formal decision on the substance of the complaint and there is no published ruling on our website.

The Commission has asked that the paper remove the articles temporarily until the conclusion of the PCC investigation. This is without any admission of liability on the paper’s part.

So no order was issued, no judgement was made and there is no suggestion of impropriety by Deer or the Sunday Times. All the suggestions come from one source, Wakefield himself. His friends on the web may try to pretend that this is further proof of the brave maverick doctor’s innocence in the face of a vicious campaign against him. I think they are clutching at straws.

Time for a cordon sanitaire?

28 Jun

The politics of autism are enmeshed in the debate about vaccine safety over the past ten years, and will take years to be disentangled. In the UK things might be changing, but in the US high profile celebrities have given a late push to fears that by now should be consigned to history. The BMJ have run a feature piece on the “Vaccine Disputes” currently running, focusing on both the UK and US experience. Here are some points made about the UK’s anti-vaccine movements, that both highlight the problems these groups pose for vaccination policies and autism, and their weaknesses.

One of the main drivers of the safety fears are antivaccine groups. Prominent among the UK groups is Warrington based JABS, whose website still maintains that “some children have and will continue to be damaged by combined and single dose vaccines.” Founder Jackie Fletcher has a son with epilepsy and brain damage, which she blames on the MMR vaccine. Her views are widely quoted by the mainstream media.

Another group is the One Click Group, whose tactic is to circulate by email a digest of antivaccination press cuttings, “Mother wants answers as baby dies from vaccine,” is one recent headline taken from a local paper in Trinidad and Tobago. The group has emailed several members of BMJ staff, all of whom found themselves unable to unsubscribe from the unsolicited email. The group, run by a former public relations worker, Jane Bryant, is especially uncompromising in its message. Ms Bryant first came to prominence campaigning to get chronic fatigue syndrome treated as a medical condition.

[…]

Pru Hobson-West, a senior research fellow at the Centre for Applied Bioethics, University of Nottingham, has identified and studied 19 groups in the UK that are critical of vaccinations.5 They included Action against Autism in Glasgow and the London based vaccination.co.uk. She found the groups were all relatively small and led by one or two parents, with a membership base ranging from 60 to 2000.

Ms Hobson-West discovered the more radical groups didn’t necessarily have personal experience of vaccine damage but were often seasoned campaigners for causes such as alternative health and animal testing.

Pru-Hobson-West’s comments ring perfectly true. The same names tend to reappear like weeds in pavement slabs, and a degree of cross-over of key individuals between organisations seems apparent. What we have are highly motivated axe-grinders, some of whom may be motivated because they feel they have genuine grievances. Some, however, are complete crackpots with no stake in either vaccine safety or autism, apart from slightly unhinged views on a variety of subjects. These lead them to take an anti-vaccine stance. So, we have alternative health practitioners with a ideological opposition to vaccines, obsessional individuals who think Roy Meadows is part of a huge establishment conspiracy, and the author of a website that believes vaccines are part of a genocidal plan, while at the same time promoting holocaust denial material. The One Click Group has even resorted to homophobic arguments. These are not people to be taken seriously. In fact, these are people to studiously avoid. Any autism organisation would do well to throw up a cordon sanitairearound such parties and their associates. Here’s how they treat individuals.

David Salisbury, director of immunisation at the Department of Health, says he has received threats at home and at work from activists. He says the “degree of anger” seems similar to that of animal rights activists. “One GP who used to be connected to JABS recommended that capital punishment was appropriate for me. Why should I accept it? This degree of personalisation.”

Neither Generation Rescue nor JABS replied to my questions.

The One Click Group was hostile when I approached them with some straightforward questions. I was directed to another charity and, bizarrely, Peter Fletcher, former chief scientific officer at the Department of Health. When I asked to be taken off its mailing list I was told: “Unsubscribing from the One Click News Alerts requires one mouse click. If this is beyond you, never mind eh?”

And yet the media (including the BBC and broadsheets) continue to give these organisations publicity.

Professor Salisbury says: “There is no doubt that the media give disproportionate weight to the [antivaccine position]. Look at the frequency that journalists writing articles about immunisation go to Jackie Fletcher for a comment.”

“For some campaigners no study is acceptable if it continues to show no link—you get answers by rote: the study was weak, didn’t look at the right children, didn’t use the right method. It’s like AIDS denialists, and there are evidence denialists. The constituency base [of these groups] has got narrower and narrower. There are a diminishing number of people who think [there is a link]. Look at the number of people who contribute to the JABS website; it’s down to a tiny number.”

He’s right. These groups are increasingly talking to themselves (at least in the UK). They have nothing to offer.

MMR doesn’t cause autism: Generation Rescue study proves it!

7 May

Generation Rescue is making a big deal out of their “study” on autism and vaccines. This was a very dishonest attempt to promote their view on autism and vaccines, no doubts about that.

While analyzing their study, I realized how much easier it is to think like someone from Generation Rescue. Rather than challenging my own conclusions, why not go the GR way and start with a conclusion and look for data–any data–to support it! This is a LOT less work, and, heck, fun too!

Let’s take a look at the question, Does the MMR vaccine cause autism? Well, GR has conveniently given us enough data to draw a conclusion! Forget the fact that the GR “data” is bunk. Remember, no critical thinking allowed for this analysis–are we not pseudoscientists? We are Gee-Ar!

Let’s look at autism prevalence by country and compare that to whether they use the MMR vaccine or not. That sounds like we should be able to come to some definite conclusions!

Here are the autism prevalence by country and whether they use the MMR shot in their schedule. (European data are here, Israel here, Japan here).

We are going to ignore the data from the United States. Why? Because it doesn’t fit our conclusions, silly. If you are going to think like GR, go all the way, I say!

Country, prevalence, MMR status:

Denmark: 1 in 2,200. MMR at 15 months
Norway: 1 in 2,000. MMR at 15 months
Iceland: 1 in 1,100. MMR at 18 months
Israel: 1 in 1,000. MMR at 12 months.
Sweden: 1 in 862. MMR at 18 months
Finland: 1 in 719. MMR at 14-18 months
France: 1 in 613. MMR at 12 months and second shot at 13-24 months
Japan: 1 in 475. No combined MMR

Wait a minute–who has the highest prevalence? Japan!!!!

Who doesn’t use the combined MMR shot? Japan!!!

Pretty conclusive, I say (as long as I have my Generation Rescue Thinking Cap on!). MMR doesn’t cause autism!

Hey LeftBrain/RightBrain–this is too tempting. It is so much easier than real blogging. As compared to real scientific research, GR research is a snap! I may just have to accept the vaccine hypothesis just to save some time!

[edit to include correction from the comments!]

Generation Rescue: a dishonest autism charity?

6 May

Generation Rescue has a long history of promoting bad science. They even have tried their hand at it themselves before, with a phone survey that was so bad it would have earned a college freshman in epidemiology a failing grade.

So when they came out with their own “study” of vaccination rates around the world, you can imagine I didn’t expect it to be good. In fact, I just avoided it altogether until they sent me an email telling me how good it was.

So I looked.

It was worse than I expected. Far worse.

The “study” is here. Generation Rescue (GR) looks at the vaccine schedules for multiple countries and compares this with the infant mortality rate and autism rates in those countries.

I read it and, Oh…my…god… I expected bad science and poorly/biased interpretations. Instead, what I found was pretty clear evidence that Generation Rescue is knowingly distributing misleading information.

Before you get worried that this post is way long and question whether you really want to read the details, here’s the short version:

1) They compare infant mortality rates between the US and other countries–even though it is clear (according to their own expert no less!) that the US uses different criteria for infant mortality and it isn’t accurate to compare the US infant mortality to that in other countries.

2) They compare autism rates amongst countries to show the US has the highest rate, suggesting that the higher the number of vaccines the higher the autism rate. They just “forget” to tell you that the prevalences for the other countries are from old studies. We can debate why the reported autism prevalence is going up with time, but no one debates that the older studies report lower prevalences than we see now. So, why does Generation Rescue compare prevalence in the US using 2002 data for kids born in 1994 with, say, a Finnish study using 1997 data on kids born as early as 1979? I consider them very biased, but not incompetent enough to miss those fatal mistakes in their study.

3) They claim that the US has the highest vaccination rates and the highest autism rates. They conveniently ignore prevalence from Canada and the UK, which have comparable prevalences to the US and much much lower numbers of vaccines. Yes, you read that right, they left out the well known studies that would show that their conclusions are nonsense.

The worst part is that it is almost certain that Generation Rescue didn’t make an honest mistake. These are so obvious that whoever wrote that “study” had to know he/she was producing what amounts to the lowest form of junk pseudoscience.

For those who want the gory details, here they are:

Infant Mortality Rates

Generation Rescue points out that the reported infant mortality rate is highest in the United States, which also has the most childhood vaccines. All well and good, but can we really compare the infant mortality rates from country to country?

When I type infant mortality rate into a google search, the first hit is a Wikipedia page which, as it turns out, addresses exactly this question.The answer is a resounding “NO”, we can’t compare the US infant mortality rate with that of other countries.

While the United States reports every case of infant mortality, it has been suggested that some other developed countries do not. A 2006 article in U.S. News & World Report claims that “First, it’s shaky ground to compare U.S. infant mortality with reports from other countries. The United States counts all births as live if they show any sign of life, regardless of prematurity or size. This includes what many other countries report as stillbirths. In Austria and Germany, fetal weight must be at least 500 grams (1 pound) to count as a live birth; in other parts of Europe, such as Switzerland, the fetus must be at least 30 centimeters (12 inches) long. In Belgium and France, births at less than 26 weeks of pregnancy are registered as lifeless.

So, who wrote that 2006 article in US News & World Report?

Bernadine Healy.

Yep, the same Bernadine Healy that is Generation Rescue’s favorite “mainstream” doctor.

One has to believe that GR saw that article in Wikipedia and the US News article. They are, after all, Google Ph.D.’s. Given the author was Bernadine Healy, they have to have considered it accurate, don’t you think? And, yet, GR conveniently forgets to mention the differences in how the US and other countries count infant mortality in their vaccines cause autism “study”.

Autism Rates 1: Autism Prevalence by country

Start with the conclusion of the Generation Rescue “study”:

This study appears to lend credibility to the theory that the U.S. vaccine schedule is linked to the U.S. epidemic of autism, particularly when compared to the published autism rates of other countries.

Given this bold claim, it is critical that they use good data for the autism rates. By “good” I mean that they need data that they can accurately compare to the CDC reported prevalence of 1 in 150. That data was taken in 2002 on 8 year old children. I.e. kids born in 1994. Since reported prevalence numbers are going up with time, it would be very misleading if they were to use, say, prevalence numbers from the early 1990’s, wouldn’t it?

Any prevalence that they use would have to use prevalence numbers from about the same time, on kids of about the same age.

Here’s their table comparing the autism rates.

gr_table3

Let’s take a look at the studies they cited for their numbers, shall we?

Iceland: Prevalence of Autism in Iceland. This 2001 study uses kids from birth years 1984-1993. I.e. most (if not all) of the kids are from the time before the big upsurge in autism diagnoses. Hardly a good comparison to the 2002 CDC study, eh?

For Sweden, they use a paper called, “Is autism more common now than 10 years ago?” from The British Journal of Psychiatry. Published in… 1991. That’s pre DSM-IV. Amongst other problems, they won’t be including the other PDD’s in the autism spectrum, like the CDC study does. Besises, the kids from the CDC study weren’t even born yet, it was so old! Is there any wonder that the Swedish study shows a lower prevalence?

For Japan, they use a paper titled Cumulative incidence and prevalence of childhood autism in children in Japan. The study uses data from 1994 on kids who were born in 1988.

Are you starting to see the pattern here? Time after time, GR is comparing US 2002 prevalence data to much older data from other countries. Let’s go on:

For Norway, they use the paper Autism and related disorders: epidemiological findings in a Norwegian study using ICD-10 diagnostic criteria. The paper was published in 1998 on children 3-14 years of age. Simple math suggests they had kids with birth years going back to at least 1984 in that study. Hardly a good comparison to kids born in 1994.

For Finland, they use Autism in Northern Finland. Here is an updated version from 2005. The study uses data from 1996-97, on kids up to 18 years old. I.e. they are using kids that were born as early as 1979. Also, they are using data on patients from hospital records who used “communal health services”. Sounds a lot like “inpatient”–one of the critiques that GR uses against studies from Denmark. Also, the Finland study didn’t include Aspeger syndrome, as that was a new diagnosis at the time. Hardly a good comparison to the CDC study.

For France, they use Autism and associated medical disorders in a French epidemiological survey. This uses “French children born between 1976 and 1985”.

For Israel, they use Autism in the Haifa area–an epidemiological perspective. This paper looks only at autistic disorder (no PDD-NOS, no Aspergers, no Rett’s no Childhood Degerative Disorder). Right off the bat that reduces the prevalence and makes it impossible to compare the the CDC 2002 study. The Israell study also is, you guessed it, based on kids older than the CDC study: children born between 1989 and 1993.

Last, Denmark. If you’ve been following the thimerosal debate, you know this is going to be ironic. They use Madsen’s paper, Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data. Generation Rescue refers to this study (incorrectly, I might add) as “This one goes beyond useless”. I guess “useless” is only when it is used to refute the thimerosal hypothesis? Come on, GR, this level of hypocrisy is just painful.

Missing Studies

There are some very well known studies that Generation Rescue somehow forgot to include in their “study”. Could this be due to the fact that they are very good counterexamples to the vaccine-hypothesis ? Let’s look at some and see, shall we?

United Kingdom: Pervasive Developmental Disorders in Preschool Children: Confirmation of High Prevalence ( study performed in 2002 with a prevalence of 1 in 170), and Pervasive developmental disorders in preschool children (study performed in 1998/9 with a prevalence of 1 in 160).

Canada: Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations (birth years 1987 to 1998. Prevalence 1 in 154).

Wow, the United Kingdom and Canada have prevalence numbers comparable to those in the US!

So, let’s complete the comparison, shall we? What is the vaccine schedule like for the UK and Canada? Using the Generation Rescue “study” we get 20 vaccines for Canada and 21 for the UK.

Wow, that’s way less than the US (with 36), and they have the same autism prevalence as the US? How could that be? Is it, perhaps, that the autism is NOT related to the number of vaccines in a given country’s schedule?

Anyone doubt why GR left the UK and Canada off their table of Autism Prevalences Around the Globe? No, I am not giving them a pass that this could be an honest mistake.

To quote Generation Rescue’s top funny guy (Jim Carrey), “How stupid do you think we are?”

Nothing to do with us: Measles in Wales

25 Apr

The recent measles outbreak in Wales occurred near Swansea. The local newspaper in the area gave publicity to the autism-MMR vaccine hoax, and may have been behind the area’s relatively poor vaccination rate. Tammy Boyce’s Health Risk and News: The MMR Vaccine and the Media described an examination of the Swansea MMR uptake rates:

Mason and Donnelly (2000) examined coverage of the MMR/Autism story in the local Swansea paper The South Wales Evening Post (SWEP) and compared the Swansea MMR uptake rates with the vaccination rates across Wales. Since 1997, coverage of the MMR vaccine in the SWEP has primarily challenged the safety of the triple jab and supported Wakefield’s theories. Many stories, predominatly written by one journalist, covered the experiences of parents who claimed their child’s autism was linked to MMR vaccine.  Mason and Donnelly found the MMR uptake in the Swansea area declined by 13.6% compared to 2.4% in the rest of Wales, ‘a statistically significant greater decline in the distribution area of the SWEP’. They admit their conclusion cannot claim a causal relationship but they do suggest the newspaper ‘has had a measurable and unhelpful impact over and above any adverse national publicity’.

The newspaper concerned does not make the link between its reporting and reduced MMR vaccine uptake, when reporting the recent outbreak. On August 24th, 2007 the paper was reporting that the low uptake rates for MMR vaccine were a ticking time bomb.

SWANSEA is facing a ticking health time bomb, GPs have warned.
They say unless more mums and dads make sure their youngsters are protected by the MMR jab, the city could face a measles epidemic.
Latest figures show thousands of schoolchildren are being placed at risk because they are not fully protected by the MMR vaccination.
Health chiefs say around 10,000 youngsters aged under 15 are not completely covered because they have not had the full course of treatment. For the vaccine to be effective, children need two jabs. The injections should then protect youngsters from measles, mumps and rubella.
However, uptake in Swansea is among the lowest in Wales.

This can hardly be a surprise to the paper, since less than a month earlier the paper had published an article called “Doctor calls for truth on vaccines” (July 30th 2007) which provided free publicity for Dr Richard Halvorsen. The following extract will allow you to play “anti-vaccine” statement bingo:

Dr Richard Halvorsen, raises his concerns – warning that the Government “misleads us about vaccines”.
Author of a new book, The Truth About Vaccines, he claims that UK children are being used as “guinea pigs” and given “unnecessary” jabs for illnesses such as mumps, and a vaccine for whooping cough which has been “ineffective” in stamping out the illness.
Halvorsen is a GP who has spent five years researching vaccination.
He said: “Vaccine programmes are not the magic bullet cure that they are claimed to be, and bombarding children with a cocktail of vaccines could be causing some serious health problems, with hundreds if not thousands of children adversely affected every year.”
Dr Halvorsen points out that a child is supposed to have 25 vaccines by the time they are 15 months old.
“There remains uncertainty whether the growing number of childhood vaccinations is contributing to the rising numbers of children affected by asthma, diabetes and other immune related disorders,” he claimed.
[…]
“I have been told that there is no one study that can disprove that MMR may cause 10 per cent of autism cases in this country in susceptible children. Studies can show that MMR does not cause all autism.

The Mason and Donnlly paper cited by Boyce is here:

Mason, BW and Donnelly, PD (2000) ‘Impact of a local newspaper campaign on the uptake of MMR vaccine’, Journal of Epidemiological Community Health, 54: 473-474 [link]

Seven years after warnings about their reporting on MMR vaccine, SWEP continued to publish dangerous nonsense about vaccines.