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A Comparison of Autism Prevalence Trends in Denmark and Western Australia.

15 Feb

I bring this up because there is a common argument that the autism “rates” in places like Denmark and Sweden are much lower than those in the US and elsewhere. This is used to try to negate studies using those country’s populations in, for example, showing that there is no increased risk from thimerosal or the MMR vaccine. This error often stems from comparing “incidence” to “prevalence”.

Is the autism prevalence low in Denmark? Not really. This paper just out (and other reports previously, including this one cited by Steven Novella) show a prevalence pretty comparable to the US.

J Autism Dev Disord. 2011 Feb 11. [Epub ahead of print]
A Comparison of Autism Prevalence Trends in Denmark and Western Australia.

Parner ET, Thorsen P, Dixon G, de Klerk N, Leonard H, Nassar N, Bourke J, Bower C, Glasson EJ.

Institute of Public Health, Department of Biostatistics, University of Aarhus, Aarhus, Denmark.
Abstract

Prevalence statistics for autism spectrum disorders (ASD) vary widely across geographical boundaries. Some variation can be explained by diagnostic methods, case ascertainment and age at diagnosis. This study compared prevalence statistics for two distinct geographical regions, Denmark and Western Australia, both of which have had population-based registers and consistent classification systems operating over the past decade. Overall ASD prevalence rates were higher in Denmark (68.5 per 10,000 children) compared with Western Australia (51.0 per 10,000 children), while the diagnosis of childhood autism was more prevalent in Western Australia (39.3 per 10,000 children) compared with Denmark (21.8 per 10,000 children). These differences are probably caused by local phenomena affecting case ascertainment but influence from biological or geographical factors may exist.

Prevalence of 68.5 per 10,000 children. A previous estimate was 80 per 10,000. Generation Rescue claimed a rate of 1 in 2200 (4.5 per 10,000) when they tried to make the case that…oh I bet you can guess…that vaccines cause autism. The 1 in 80 figure was already published, so I doubt they will change their story given yet another study.

Fact checking the Age of Autism’s defense of Andrew Wakefield

11 Jan

The BMJ article, How the case against the MMR vaccine was fixed, has had a lot of media coverage in the United States. With that coverage has come the defense of Andrew Wakefield, by himself and a few others. As a part of the defense (arguably the bulk of the defense) has been an attack on Brian Deer, the investigative reporter who wrote the article. I say attack because the main accusation, as you will read below, is false. Easily verified as false.

Consider this, on CNN’s Anderson Cooper 360, Mr. Wakefield made the accusation:

WAKEFIELD: Well, that’s interesting you should say that, because he was supported in his investigation by the Association of British Pharmaceutical Industries, which is funded directly and exclusively by the pharmaceutical industry. So…

On CNN with Ali Valshi, Generation Rescue founder J.B. Handley made the following statement:

“The British Medical Journal is only publishing allegations from a single investigative journalist named Brian Deer, who was funded by a pharma front group for four years to investigate Andy Wakefield.”

He later states that Brian Deer was “…funded by pharmaceutical groups from the getgo”.

Where did this accusation come from?

In a blog post, Mr. Handley let’s us know how he came to this conclusion:

In fact, Deer was originally funded to investigate Andy by a front group for the Association of the British Pharmaceutical Industries, just as Andy Wakefield said. From a confidential source:

“Deer was provided with free assistance by Medico-Legal Investigations a company owned and controlled by the Association of the British Pharmaceutical Industry – I have documentation on this. MLI specialise in getting medical doctors prosecuted by the General Medical Council. And that was done before he published in The Sunday Times in Feb 2004.”

We also see the story shifting we also see the story shifting. Instead of “funded from the getgo” or “funded by a pharma front group for four years” we find that he was given “free assistance” We don’t even know how much free assistance.

An unsupported assertion is made that the company is “owned and controlled by the Association of the British Pharmaceutical Industry”.

At least we have something we can verify. A claim like this should be verified, one way or the other. So I did. I contacted Medico-Legal Investigations. I posed a simple question:

You may be aware that Brian Deer has recently published the findings of his investigations showing that Andrew Wakefield committed research fraud in his investigations into MMR and autism. In retaliation, Mr. Wakefield and his supporters are claiming that Mr. Deer is conflicted himself. As part of this, they claim:

“When Brian Deer began his investigation of Andy Wakefield, he was supported by a pharmaceutical front group”

To support this, they claim:

“Deer was provided with free assistance by Medico-Legal Investigations a company owned and controlled by the Association of the British Pharmaceutical Industry – I have documentation on this. MLI specialise in getting medical doctors prosecuted by the General Medical Council. And that was done before he published in The Sunday Times in Feb 2004.”

Can you confirm whether this statement is, in fact, true?

The response?

The statement in bold lettering is totally false. We had no idea he was undertaking this investigation until he was about halfway through. At that point, and knowing that we were the only people in Europe experienced in the investigation of research fraud and misconduct, he contacted us to seek advice on a general issue related to Ethics Committees. We had a one off meeting with him and were able to offer guidance without knowing the details of the confidential investigation. I would like to know how anyone can say we are a pharmaceutical front group – we have always retained our independence.

We have never been owned or controlled by the ABPI – that is complete and utter nonsense. We have been supported by the ABPI and, indeed, the medical Royal Colleges. In order to ease our cashflow crises (there is never enough work to cover the costs of running a business) a few pharma companies paid an annual subscription to us in return for reduced rates for training and investigations. That does not mean that we were controlled by them. I pay annual subscriptions to magazines and get cheaper copies but I do not have editorial control!

Finally we specialise in the investigation of possible fraud/misconduct in research. When we are 70% certain that we have enough evidence to prove serious professional misconduct we report the facts to the GMC who conduct an Inquiry into the allegations. We also investigate other health sector matters and if a criminal offence is disclosed we report to the police or embark upon a private prosecution through the lawyers of our clients (other statutory bodies). The protection of patients is primarily our concern.

I hope this helps

Shall we count the errors in Mr. Handley’s attack?

1) Medico-Legal Investigations had no part in the investigation. They only offered a one-off meeting on medical ethics. Medico-Legal Investigations was unaware of the specifics of Mr. Deer’s investigations.

2) Medico-Legal Investigations is not “owned and controlled by the Association of the British Pharmaceutical Industry”. Thus it is not a “front group”.

3) On top of all that, Mr. Deer was not even funded by Medico-Legal Investigations.

4) The association with Medico-Legal Investigations was a simple meeting, as Mr. Deer was over half way through his investigation. The association was not “from the get go” and was not “four years” (funded or not).

In essence, we see what Mr. Wakefield and his supporters are reduced to: a publicity campaign. Get their message out, accurate or not. Attack the source rather than address the allegations.

The Big Lie – what Andrew Wakefield did was possible and fraudulent

10 Jan

Earlier this week, the blog Child Health Safety published a piece claiming it was impossible for Andrew Wakefield to have acted fraudulently. Earlier today, JB Handley of Age of Autism published a similar piece:

“It was not possible for Wakefield or anyone else to falsify the prior clinical records of the children because no one at the Royal Free Hospital London had them nor is it normal practice for them to have had them. So there could be no fraud over ‘altering’ those histories. It just was not possible.”

Plain English: In Britain, when you are referred from a local doctor to a major hospital, like the one where Andy worked, your previous doctor’s records DO NOT travel with you.

Hmmm. Lets look at the definition of the claim of fraud from the editorial in the BMJ.

The Office of Research Integrity in the United States defines fraud as fabrication, falsification, or plagiarism. Deer unearthed clear evidence of falsification. He found that not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and that in no single case could the medical records be fully reconciled with the descriptions, diagnoses, or histories published in the journal.

This quite clear – but don’t CHS blog and JB Handley have a point? If Andrew Wakefield couldn’t see the NHS records, how could he have falsified data? He might have been wrong, but fraud? No. If Wakefield couldn’t have seen those NHS records he could not have altered data from them to enhance his Lancet piece.

Except he _did_ see these children’s NHS records. From the very paper itself, we can glean the following:

12 children (mean age 6 years [range 3–10], 11 boys) were referred to a paediatric gastroenterology unit
with a history of normal development followed by loss of acquired skills, including language, together with diarrhoea and abdominal pain. Children underwent gastroenterological, neurological, and developmental assessment and review of developmental records.
Ileocolonoscopy and biopsy sampling, magnetic-resonance imaging (MRI), electroencephalography (EEG), and lumbar puncture were done under sedation. Barium follow-through radiography was done where possible. Biochemical, haematological, and immunological profiles were examined.

Developmental histories included a review of prospective developmental records from parents, health visitors, and general practitioners.

This is quite clear. Wakefield saw the NHS records of the Lancet 12. The claim that he didn’t is incorrect at best.

JB Handley of Generation Rescue on CNN

6 Jan

First of all, here’s the transcript of Handley on CNN, courtesy of Liz Ditz:

Parker: Now joining us from Portland, Oregon I J.B. Handley. JB is the father of an eight-year old with autism, and he is a founder of Generation Rescue, a group that believes that there is a connection between autism and vaccination. Welcome JB

JB Handley (JBH): Thanks for having me.

Parker: Thank you Did today’s report cause you to reconsider your position on vaccines at all?

JBH: No, not one bit.

Parker: So, explain that. Why doesn’t this affect the way you think?

JBH: You know the original Wakefield study looked at 12 children. All 12 had autism. The only conclusion of the study was that the 12 were suffering from a new form of bowel disease. Andy Wakefield also reported that 8 of the parents said that their children regressed after the MMR vaccine. So the notion that his study ever incriminated MMR as causing autism is false. and the vaccine industry continues to beat this dead horse.

Parker: so you think that um when you talk about regression you are saying not so much that uhm the vaccine causes autism but that it causes a regression? And what does that mean to you?

JBH: No. What you hear from many parents, and my son is one of these, is that the children are developing typically, and my son’s case up to 14 months he was normal, and then then they gave a regression, they start to lose skills, they start to lose milestones. I have personally talked to about a thousand parents who all report that their children where that regression took place immediately following a vaccine appointment.

It’s important for parents to understand that children are given 36 vaccines in the US by the time they are the age five. The MMR only accounts for two of those 36 vaccines. Typically the shots are given simultaneously so the average child will get six vaccines in a single appointment, yet we don’t have a single piece of research to understand the potential risk of all those vaccines at once. So when someone tries to tell me that MMR alone doesn’t cause autism, but I take my child in for a vaccine appointment, and they are getting six shots in 10 minutes, how am I supposed to feel reassured?

Spitzer: I say this with overwhelming sympathy for you and for your son, but just listening to you I’ve got to ask the question: there isn’t a single study, and we’ve looked at all the science, that says there’s any causal link between these vaccines and autism. And I know you are saying there is

JBH: But that’s not true

Spitzer: there isn’t a study that disproves it, but there’s no affirmative causal link there. And so don’t don’t you think it would make more sense to look at other potential potential causative factors?

JBH: What you are saying is simply false. There is a study out of SUNY Stonybrook within the last six months that compared a group of children who got the entire round of HepB vaccine, and a group of children who didn’t, and found autism was three times more likely in one group. There’s a new study out of the University of Pittsburgh that took primates and vaccinated a group of them and didn’t vaccinate the another and found dramatic differences between the two sides. So to represent that somehow the science has been done is simply false. More importantly the science that has been done is what we like to call “tobacco science”. You take a group of kids who all got vaccines but got a little less mercury and compare them to a group of kids who all got vaccines but a little more mercury and find there’s no difference in autism and then claim that vaccines don’t cause autism. The only appropriate study to do would be to look at a group of children who never got vaccines and a group of children who got all of them, and see if there’s a difference in autism rates and that study has never been done despite many people trying to call for it.

So to represent that the science has been done on this is simply untrue. The vaccine makers are highly effective at PR and which is why I am here talking to you.

Parker: Well JB you obviously feel passionately about this and we can certainly understand that. How do you feel specifically about, when you find out that this particular doctor was when Wakefield was actually deliberately fraudulent in advancing the claim that there was a connection?

JBH: What is interesting is that there are 12 children in the original study in the Lancet, OK? The parents of the 12 children have all written letters, time and again, in support of Andy Wakefield. The study’s conclusion was that the children were all suffering from bowel disease, and Andy went on to mention eight of the parents claimed that the regression took place after the MMR. So the notion that the data is somehow new, what’s new? They didn’t suffer from bowel disease, even though all the parents have represented that they did? People need to look at the details not at the headlines. This an attempt to whitewash, once and for all, the notion that vaccines cause autism. They are not just beating a dead horse, they are beating a horse that never existed in the first place. That’s not what Wakefield’s study said. It’s a seven page page study, it is on the Generation Rescue website. Anybody can read it for themselves and verify what I am saying is true.

Spitzer: JB, again with all sympathy, and as somebody who has been a harsh critic of

JBH: I don’t need any sympathy!

Spitzer: Well, OK but what I am trying to say is

JBH: [talking over] I don’t need any sympathy! I don’t need your sympathy What I need is the facts and for someone to look at the details.

Spitzer: Well what you yourself have said is that what you glean from your anecdotal conversations is hugely compelling to you but unfortunately in terms of the scientific data and the analysis that sort of anecdotal database simply doesn’t establish the causal link what we are looking for in terms of really understanding this and I think that what validates today

JBH: [talking over] Look at the Suny Stonybrook study, look at the university of Pittsburg study

Spitzer: [continuing over JB] this study that we examined today was fraudulent. And I think that’s really where we are.

JBH: [talking over] Look at the Suny Stonybrook study, look at the university of Pittsburg study. You haven’t done all your research. You are reaching false conclusions. Parents do your own work.

[pleasantries to close]

Now lets isolate Handley’s main talking points and decide if they are true or false:

1) You know the original Wakefield study looked at 12 children. All 12 had autism.
Not accurate. According to material from the British Medical Journal three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism.

2) Andy Wakefield also reported that 8 of the parents said that their children regressed after the MMR vaccine.
Not accurate. According to the same source five had documented pre-existing developmental concerns.

3) So the notion that his study ever incriminated MMR as causing autism is false.
Semi-accurate. Although the paper itself may not have mentioned it, the video conference Wakefield gave _about_ the study certainly did:

…you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR…

4) …we don’t have a single piece of research to understand the potential risk of all those vaccines at once.
Not accurate. Any vaccine in the US has to undergo something called a ‘concomitant use study’. These are to establish that vaccines work OK together. Searching Pubmed for the phrase ‘concomitant vaccine’ returns over 700 results.

5) There is a study out of SUNY Stonybrook within the last six months that compared a group of children who got the entire round of HepB vaccine, and a group of children who didn’t, and found autism was three times more likely in one group
Not accurate. This study is flawed on an number of levels. Firstly, they are comparing kids born as early as 1980 to kids born during “the epidemic”. Anything that happened past 1991 would be an autism risk. Secondly and very worryingly, they pick datasets that have children born before the introduction of the Hep B vaccine. Thirdly, this whole thing is essentially a survey. It’s based on parental recall.

6) There’s a new study out of the University of Pittsburgh that took primates and vaccinated a group of them and didn’t vaccinate the another and found dramatic differences between the two sides.
Not accurate. Again, lots of issues with this study. So many so in fact that Sullivan wrote a devastating takedown of the paper in July last year.

I think that’s all the statements of attempted fact from Handley. All in all it shows that Generation Rescue cannot be trusted to present the most pertinent or up to date information.