Archive | Vaccines RSS feed for this section

Another misinterpreted study. This time they are misusing Israel data

22 Feb

Kent Heckenlively from the Age of Autism blog has recent post up on a study out of Israel on autism. In it, he notes that the “incidence” of autism in Israel actually dropped for a few years

What’s curious, though, is how this population of medical professionals who were supposedly good at identifying and diagnosing autism in 1999, then had a drop of more than 40% by 2002. Did they lose their newly-acquired skills in a sophomore slump? If I’m not mistaken, those were also the years of the vaccine-autism “panic” which began shortly after the publication of Dr. Andrew Wakefield’s article in the Lancet, linking the MMR shot and autism. Was there a drop in vaccination rates in Israel after the Wakefield publication? Did vaccination rates then subsequently go up in later years?

Here’s the figure.

Figure 1 from Israel Autism Paper

Figure 1 from Israel Autism Paper

Let’s do this quickly. The interpretation is nonsense. Start from the fact that Google Ph.D.’s seem to rarely check simple facts using google.

Enter “Israel Vaccine Schedule” into google. The top link is a WHO site.

Take a look at how the MCV (Measles Containing Vaccine) coverage has varied with time.

MCV uptake was increasing steadily up until 2003, when it dropped for two years.

Year MCV Uptake Measles cases
1998 97% 8 (Year of Wakefield paper)
1999 97% 14
2000 97% 36 (year “incidence” starts to drop in Israel
2001 96% 19
2002 98% 2
2003 95% 124
2004 84% 116 (year MCV uptake drops)
2005 96% 2
2006 96% 9
2007 96% 539 (measles spike)

Obviously the drop in autism “incidence” in Israel isn’t related to measles vaccines–the drop in uptake happened after the drop in autism “incidence”. Note that I put “incidence” in quotes. The paper isn’t measuring incidence. I’ll get to that later.

In 2007, something else happened. Measles cases spiked. Yep, 3 years after vaccination rates dropped, there’s a big spike in measles. Are they connected? Possibly. I would want to see information like how many of the 539 measles cases were children 4-5 years old, for example.

Other issues with the paper.

1) they don’t give “incidence” or “prevalence”, really. They are giving the number of people who are getting services for autism. Sorta like the California DDS data. Why is this important? We don’t know how easy it is to qualify for services. We also don’t know how hard they are looking for people with autism. It isn’t the same thing as a measure of all the people with autism.

2) Note that 97.5% of the people with autism are Jewish. About 25% of the population in Israel is non Jewish (if Wikipedia is accurate). So, is being Jewish a “risk factor”, or is there an issue with access to services.

3) According to Mr. Heckenlively, the prevalence of Autism in Israel is 1 in 2,400. I guess low prevalence numbers invalidate studies when they are in Denmark, but not when they are in Israel?

By the way, consider that low “incidence” value for Israel. Now look at their vaccine schedule (I am only listing those for very young children)

DTaPHibIPV: 2,4,6,12 months
HepA: 18, 24 months
HepB: Birth, 1, 6 months
MMR: 1 year, 6 years

Hmmm. Remember how Israel has a low autism “incidence”?

Look at that first big combo vaccine–5 vaccines at once. I guess combo vaccines don’t cause autism, eh?

HepB is given at birth. I guess that isn’t a risk factor either, eh?

Separating out the combo vaccines, I count 28 different vaccines given by 24 months in that vaccine schedule. So much for “too much, too soon”, eh?

Of course, this is stretching the Israel data waaaay too far. Of course we can’t say that the Israel data prove that HepB, combo vaccines and too-many-too-soon are not risk factors. Just like we can’t use these data to support Dr. Wakefield’s hypotheses.

I’m glad to see autism studies come out of new countries. Let’s not use data with big limitations to support our preconceived ideas, shall we?

(note, I made corrections shortly after publishing. These did not change the content substantially. I did change the title to clarify that it is not the Israeli researchers who are misinterpreting the data)

Who carries the authority?

19 Feb

The recent Omnibus decisions are hoped by some to stem the tide of rabid anti-vaccine beliefs espoused by people who shame the name of autism advocacy. On Salon, Rahul K. Parikh says:

In the case of autism, science and reason have too often failed to reach people. And consequently they have turned to the courts. For those of us who believe in the scientific method, the autism trials have not been necessary. But judges, unlike doctors in their cold white coats, still command a great deal of respect, and so perhaps the court’s recent ruling will sink in and finally persuade parents to regain their confidence in vaccines.

Never happen Rahul, never happen. These same anti-vaxxers have already began spin campaigns not only against the legality of the verdicts but against the three Special Masters themselves. To this group, the Special Masters command no respect whatsoever and neither do their verdicts. Take this piece of rampant stupidity from Barbara Loe Fisher:

The U.S. Court of Claims special masters are hampered from considering evidence which has not yet been published in the medical literature regarding potential associations between vaccines and the development of regressive autism

I don’t see how it is possible to make a dumber statement. What she’s saying is she wanted the Special Masters to look at unpublished science. As is well known, unpublished science is not like an unpublished novel. Unpublished science means its science that has not been put through the rigour of peer review, not had its methods examined to ensure they are transparent and reproducable, not had its conclusions reviewd to see iof they are accurate and not had its data examined to see if it is usable. This unreviewed, unpublished ‘science’ is what got us to this stage in the first place. A ten year multi-million pound, dollar and euro effort to close down bad science.

So how does she and people like her get away with saying such things? *Just because they can* . Because people believe extremes and people believe celebrities. People believe bloggers and people believe those who have shared (or think they have) experiences. I’m not saying its right but its true. If anyone genuinely believes this ruling will shut the door on these people they’re wrong. For confirmation of that you need look no further than Rolf Hazlehurt, father of one of the kids who made up the three test cases from the Autism Omnibus.

If we win, we keep going.
If we lose, we keep going.
If we win, the going will be easier.
If we lose, the going will be more difficult.
However, the Court rules, we will keep going.

You have to understand. This is not about scientific truth – or even truth at all – to these people. Its about winning and its about pushing their antivaccine beliefs as fast and far as they can. Even as they claim to not be anti-vaccine they write emails to others clearly showing they are. One of these emails will come to light very soon I believe. Expect to see very familiar names on it.

To these people science has no authority. Doctors have no authority. The Special Masters have no authority. The only people who have authority – real authority – can probably be counted on the fingers of one hand. David Kirby. Jenny McCarthy. Maybe Dan Olmsted. If one of these people were to bow to the obvious and say so publicly then we might have a very different scenario. But they won’t. They have too much invested in esposuing the anti-vaccine line.

Mainstream media have a lot to apologise for also. The red tops, the broadsheets and all those hundreds of little bitty TV channels all over the US that gave the anti-vaxxers airtime in the name of impartiality and allowed them to scare away facts and reason, they need to reverse that policy.

But more than that, scientists and doctors need to get online and blog, get on Twitter and use them. Talk to people in their own language. Screw decorum. Ask people who’ve been using their blogs to support vaccines for _years_ what to do and how to do it. People like Oracand Ben Goldacre are prime examples.

This needs to happen because we’ve already lost one generation of kids to their loony parents. The loony parents who only recognise the authority of celebs, authors and each other in nests of email lists and blogs. If we want to give up another generation to the reach of the internet then keep on keeping on and hope that Rahul K. Parikh is right. But he’s not.

Brian Deer, not a complainant

16 Feb

Just in case you didn’t see it–Brian Deer published more information about Dr. Andrew Wakefield recently. This has caused a lot of furor (we are over 160 comments on that thread already). No surprises there: saying anything which might suggest Dr. Wakefield is anything less than a hero, especially when Brian Deer is doing it, will do that.

Almost all (if not all) of the responses to Brian Deer’s piece has been one big diversionary tactic: attack the messenger. Everyone seems to be studiously avoiding facing the real tough questions. Let’s avoid the ethics questions for the moment. If the details Mr. Deer presented in his article are true, Dr. Wakefield’s autism research has lost any last shred of support. That is a tough pill to swallow for the Wakefield supporters.

David Kirby joined in on the Deer bashing. Seems he read an article by Melanie Philips and rehashed it for his fans on the Huffington Post. He found Ms. Philips’ story to be “very interesting reading”. You see, Ms. Philips postulated:

What the Sunday Times did not report was that the GMC investigation into Wakefield was triggered by a complaint from… Brian Deer, who furnished the allegations against him four years ago.

This was then spun into a story of supposed conflict of interest and a great avoidance of the direct and specific claims of possible misinformation in Dr. Wakefield’s papers.

But, back to Mr. Kirby. He states:

The point is an excellent one. Imagine if a US journalist sued a doctor for libel or misconduct, and then went to the NY Times and asked to be hired as a freelancer to cover the trial that they themselves had instigated in the first place. It wouldn’t happen.

I found that statement very ironic, coming as it did from someone who aided significantly in manufacturing the thimerosal controversy, and who now seems to owe some of his employment to servicing that same controversy.

That said, what about this notion, this postulate as I have called it, that Brian Deer initiated the investigation that he is now reporting on? Well, it turns out that Mr. Deer is not a complainant in the GMC hearings on Dr. Wakefield. Below is a letter to Mr. Deer explaining exactly that.

Strictly Private & Confidential
Mr Brian Deer

25 May 2005

Dear Brian

General Medical Council – Dr Wakefield, Dr Murch, Dr Walker-Smith

I write further to your telephone conversation with Peter Swain last Thursday seeking clarification in relation to your role in the above General Medical Council (“GMC”) proceedings.

I have now had the opportunity to review the GMC’s files. My understanding is that further to your articles appearing in the Sunday Times in February 2004 in relation to your investigation into Dr Andrew Wakefield and the MMR vaccine, you were approached by GMC case officer Tim Cox-Brown, who asked you to supply the GMC with further information regarding this matter.

Your situation as a journalist who has carried out an investigation into the conduct of the practitioners in question is unusual for the GMC. I note from the GMC and FFW’s correspondence files that there does appear to have been some confusion in relation to your role in these proceedings.

In GMC ‘complainant’ cases an individual will have approached the GMC with a complaint against a particular practitioner. If the GMC decides to hold an inquiry, legal representation is offered to the complainant for preparation and presentation of the case before the Professional Conduct Committee.

As stated in Peter Swain’s letter to you dated 16 December 2004, your role in this matter is that of ‘informant’ rather than ‘complainant’. This is due to the fact that the conduct of the practitioners in question has not affected you directly and clearly involves issues of a wider public interest.

As you are aware, your involvement the GMC’s conduct of this case prior to our commencing our investigation and subsequent to our meetings with you on 24 February 2005 and 7 March 2005 has been minimal. We are preparing this case for presentation at the Professional Conduct Committee on the instructions of the GMC. Moreover, we are not able to discuss draft charges with you for reasons
of confidentiality.

We apologise for any confusion in relation to your status in these proceedings and any difficulties this may have caused you. We have made it clear to all parties that your role is that of informant rather than complainant. Please find enclosed a copy of the letter sent to Dr Wakefield’s legal representatives clarifying your status in these proceedings.

We are grateful for information supplied by you and your assistance to date.

Yours sincerely

Matthew Lohn
Partner

So, Brian Deer didn’t initiate the investigation. He wasn’t a complainant. It isn’t like, as in Mr. Kirby’s analogy, Mr. Deer didn’t “sue a doctor for libel or misconduct”.

Let me take a page out of Mr. Kirby’s own playbook:

David, if you read this (and we both know you will), take the message to heart and write a correction to your blog piece on the Huffington Post. Better yet, put up a new one with an explanation and apology.

Omnibus: the decisions are decisive

13 Feb

The first autism omnibus proceeding decisions are in: MMR does not cause autism, either alone or in conjunction with thimerosal.

Having said that, I can imagine that some of my readers are already accusing me of spinning the conclusions. That’s because the spin has already been put forth that the decisions are weak on the idea of general causation. Another theme is that the decisions only pertain to the test case families. But, as we will see, those ideas are the spin.

Here is a section from the From Autism Speaks statement on the Omnibus:

Today the National Vaccine Injury Compensation Program ruled that the combination MMR vaccine — with and without the preservative thimerosal — did not contribute to three particular children’s autism.

Why did they chose to say “…three particular children’s autism” when they know full well that the point of using “test cases” is to discuss general causation?

TACA is less subtle:

The fact that it took this long for these three decisions has to mean that the vaccine injury evidence had some merit. Poor evidence would have produced a negative decision very quickly.

The fact that they took a long time to decide indicates a tough decision? Either they didn’t read the actual decisions or they are deliberately trying to muddy the waters. Seriously. The comments in the decisions are so clear, so decisive, that one just can not make the TACA statement in good conscious.

Take a look at what the special masters actually said. Granted, there are hundreds of pages of decisions and I am picking a few paragraphs out, but I think you will agree–the statements are very (very!) clear. The decisions were not close. It was not a struggle for the special masters to come to these conclusions.

From the conclusion of the Cedillo case by Special Master Hastings:

This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. The result of this case would be the same even if I totally ignored the epidemiologic evidence, declined to consider the video evidence, and/or excluded the testimony of Dr. Bustin. The result would be the same if I restricted my consideration to the evidence originally filed into the record of this Cedillo case, disregarding the general causation evidence from the Hazlehurst and Snyder cases. The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. The petitioners have failed to persuade me that there is validity to any of their general causation arguments, and have also failed to persuade me that there is any substantial likelihood that Michelle’s MMR vaccination contributed in any way to the causation of any of Michelle’s own disorders.

emphasis in the original.

Take a couple of lines out, shall we? Starting with, “…not a close case”. He even emphasized it with italics.

“The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. ”

and

” The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. ”

This is a clear and decisive decision, not doubts about it.

From another section of the decision, this one entitled Summary concerning general causation issue

For all the reasons stated above, I conclude that the petitioners have failed completely to demonstrate that it is “more probable than not” that the MMR vaccination can be a substantial factor in contributing to the causation of autism, in individuals suffering from regressive autism or any other type of autism. To the contrary, the evidence that I have reviewed makes it appear extremely unlikely that the MMR vaccine can contribute to the causation of autism. It is clear that the causation theories themselves are weak, not just the case in specific for Miss Cedillo.

I expect fragments like “extremely unlikely” to be taken out of context.

An entire section of the decision (page 34) is titled, “I have found above that petitioners general causation theory concerning immune damage is without merit.”

As to part (1) of petitioners’ three-step theory (see previous paragraph), I have already explained in detail, at pp. 22-34 of this Decision, why I have found no merit in the petitioners’ theory that thimerosal-containing vaccines in general can damage infant immune systems.

Doesn’t bode well for the next three Omnibus test cases, does it? The second three focus on thimerosal alone.

Back to MMR, there are two more decisions. From the concluding paragraph to the Hazlehurst decision, by SM Campbell-Smith,

Having carefully and fully considered the evidence, the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of Yates’ autism.

Again, for emphasis, let’s pull a phrase out: “the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism”

From the Snyder case,

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis.

Pretty strong words, but I can see some people saying that there is the indication that it is just “highly improbably” raised to the sixth power. “Highly improbably^6 is not zero!” we will hear.

From another section, specifically addressing the general causation question:

However, the problems with the case presented by petitioners for general causation are overwhelming. The quality of the petitioners’ experts paled in comparison to the world-class experts proffered by respondent. The theories petitioners’ experts advanced lacked support in both logic and research. As Dr. Ward testified, an hypothesis has a life span. An hypothesis may be biologically plausible at the time it is first advanced. As evidence accumulates, the hypothesis may be strengthened or weakened. The MMR hypothesis may have appeared biologically plausible at its inception, but the accumulating body of scientific evidence has tipped the scales decisively against it. Snyder Tr. at 975. The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism. I thus conclude that petitioners have failed to demonstrate that the MMR vaccine can cause autism, even in the highly circumscribed subset of children with regressive ASD and gastrointestinal symptoms.

Again, for emphasis, here is a line pulled from the above “The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism”

It will be frustrating to watch the spin continue. I expect to hear “The decisions weren’t really that decisive” for some time to come.

But, the fact of the matter is that these decisions are clear and, well, decisive.

This is not just a statement about the spin-factor, by the way. The vaccine lawyers have just done millions of dollars worth of groundwork for their appeal and later civil cases on the taxpayer’s dollar. The fact that the Court of Federal Claims has issued such incredibly strong decisions makes it much more difficult for those cases, especially the civil cases, to actually go to trial.

Cedillos, Hazlehursts, Snyders

12 Feb

Three brave families who were placed in harms way not by an MMR injection but by a string of bad doctors, worse autism/antivax organisations and really terrible witnesses. A combination of these three factors placed these three families – they who stood for the utterly discredited idea that MMR/thiomersal or MMR alone cause autism – into harm the likes of which said doctors and founders of autism/antivax orgs will never have to face. I recall hearing that the Cedillo’s had taken out a second mortgage on their home to enable them to attend the legal proceedings.

I wonder if the leading autism/antivax groups will have enough about them to pony up to support the Cedillo’s for the rest of their lives? They should, they hung them out like a banner to wave.

This is from the Washington Post:

The decision by three independent special masters is especially telling because the special court’s rules did not require plaintiffs to prove their cases with scientific certainty — all the parents needed to show was that a preponderance of the evidence, or “50 percent and a hair,” supported their claims. The vaccine court effectively said today that the thousands of pending claims represented by the three test cases are on extremely shaky ground.

In his ruling on one case, special master George Hastings said the parents of Michelle Cedillo — who had charged that a measles, mumps and rubella (MMR) vaccine caused their child to develop autism — had “been misled by physicians who are guilty, in my view, of gross medical misjudgment.”

Hastings pinpoints the Geier’s, Krigsman and Wakefield by name in his verdict.

And here’s Special Master Vowell from the Snyder test case:

“After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were
speculative and unpersuasive.”

….

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast.

And here is Special Master Campbell-Smith from the Hazlehurt test case:

Because the linchpin of petitioners’ theory, the finding of persistent measles virus in the biopsied tissue taken from the gastrointestinal lining of autistic children, is glaringly unreliable, the basis for Dr. Corbier’s opinion that the MMR vaccine was causally related to Yates’ autism and his gastrointestinal symptoms is critically flawed and scientifically untenable. Petitioners have failed to prove that their theory of vaccine-related causation is biologically plausible as required by the first prong of Althen. Nor have petitioners demonstrated that the unsupported links of their proposed causal chain cohere to establish a logical sequence of cause and effect as required by the second prong of Althen. Having failed to satisfy their evidentiary burden, petitioners cannot prevail on their vaccine claim.

I should be happy that science has prevailed and I am to a certain degree. The fact that the Vaccine Injury Court demands a very, very low standard of proof should indicate clearly and concisely just how good the rubbish submitted as science was for these kids cases.

I can’t be happy and I can’t take any pleasure in the fact that these kids and their families have been coldly, cynically used by those who demand against all reason that vaccines cause autism. How could any right thinking person? These parents are penniless and will no doubt be coerced into taking part in a shame of an appeal, then civil cases. Civil cases where the standard of science is very much higher. I hope they step back and consider carefully the verdicts of the Special Masters, the horrendous quality of their so-called ‘expert’ witnesses and the utter lack of any science to support them.

Omnibus decisions in–acknowledging the test case families

12 Feb

The Omnibus decisions on MMR are in. Answer: no. Clearly no, they did not find that MMR with or without thimerosal cause autism. The court found that the cases were without merit.

This will obviously be a topic much discussed in the next few days. But, for right now, I’d like to acknowledge the bravery of the families who allowed their stories to be the “test cases” for the omnibus: the Cedillos, the Hazlehursts and the Snyders.

Yes, I agree with the decisions by the Court. Yes, I think the vaccine question has and will continue to sidetrack the greater autism community from more important efforts. But, the Court made a point in the decisions that the families stepped forward with good faith.

They put their lives in the public eye. They can appeal (and I expect it will happen). But they can’t do what the Krakow’s did, and what appears to be an option for the rest of the Omnibus families: change the story and resubmit to the court.

It was a good decision, and good for the autism community as a whole. For me, I’m taking at least a day to process before blogging the decision. In that time, I’d like to acknowledge that the Cedillos, the Hazlehursts and the Snyders put themselves on the line for what they believe in. They did it to try to help other families. I can disagree with them and still acknowledge the bravery of that action.

Kirby blows another irony meter

11 Feb

I need to find a source for militaryp-spec irony meters.

David Kirby has posted a piece on the Brian Deer investigation of Dr. Andrew Wakefield.

Here’s the comment that blew the irony meter:

Imagine if a US journalist sued a doctor for libel or misconduct, and then went to the NY Times and asked to be hired as a freelancer to cover the trial that they themselves had instigated in the first place. It wouldn’t happen.

So, David, you wrote “Evidence of Harm”, massively fanning the flames of the mercury causation theory.

You are now blogging on the Age of Autism blog.

Are you paid for that effort?

I haven’t seen a lot of non-vaccine/autism bylines for you in the past few years. So, if AoA is paying you, it would be a sizable fraction of your “journalist” salary.

If so, couldn’t it be well argued that you created your own “journalist” job?

Ironic, eh?

Ah well…as long as we are discussing Mr. Kirby, here is another of his comments:

In his writing, Deer claimed that Wakefield had made up results about severe MMR reactions in the children just days after receiving the shots, had ignored signs of autism in some kids before they received their MMR vaccine, and changed lab reports on the gut biopsies – among other alleged infractions that have been covered in the two year trial in London of Wakefield et al.

The accusations printed in the Sunday Times are, frankly, outlandish. And they are false.

Hmmm, false? Do you have the facts to back that up? Have you seen the medical records that Mr. Deer has reported on? It seems highly unlikely to this observer.

Let’s look at some of Mr. Deer’s claims:

Supposedly, Dr. Wakefield found measles RNA in the guts of his subjects. From Mr. Deer’s report, the father of child 11 from the Lancet study has stated that he had no fewer than 3 separate tests for measles RNA from the same gut biopsies that Wakefield tested. Three negative results.

Dr. Wakefield claimed that the children were developing normally before the MMR. According to the Deer article, another child from the original 12’s story:

The boy’s medical records reveal a subtly different story, one familiar to mothers and fathers of autistic children. At the age of 9½ months, 10 weeks before his jab, his mother had become worried that he did not hear properly: the classic first symptom presented by sufferers of autism.

Dr. Wakefield claimed that the 12 study subjects were presented sequentially to his hospital, indicating that they were randomly selected. And, yet, none of them were in the Royal Free Hospital’s catchment area–or even the greater London area. That’s one fact that doesn’t take access to the GMC’s records. And it demonstrates a clear non-random nature to the subject choice.

How about the report by Dr. Wakefield that the subjects had regressions shortly after their MMR shot? Again, from Mr. Deer’s article:

This was Child Two, an eight-year-old boy from Peter-borough, Cambridgeshire, diagnosed with regressive autism, which, according to the Lancet paper, started “two weeks” after his jab.

However, this child’s medical records, backed by numerous specialist assessments, said his problems began three to five months later.

A pretty major disconnect between Dr. Wakefield’s story and the medical records.

How about the measles-in-the-gut theory? Dr. Chadwick, working in Dr. Wakefield’s own hospital, testified in the Omnibus proceeding that he told Dr. Wakefield pre-publication that the PCR data directly contradicted the results Dr. Wakefield was publishing. Dr. Wakefield knew when he published that there were good data that showed he was incorrect. How did you sweep that under the rug, Mr. Kirby?

Did Dr. Wakefield fabricate results or is there another reason why he got a lot of very important facts wrong? I don’t know, but I do agree with Dr. Fitzpatrick who asked why Dr. Wakefield’s papers have not been retracted. They should be.

(And I thought Dierdre Imus wrote the worst blog post of the day!)

post-publication note: Dr. Mike Fitzpatrick has written an excellent article on Dr. Wakefield’s studies, including the recent information from Mr. Deer.

Fitzpatrick on the recent Wakefield news

11 Feb

Dr. Michael Fitzpatrick has written the article I wish I could have done–

The MMR scare: from foolishness to fraud?

For anyone looking to understand the timeline and the important questions raised by the Brian Deer investigations, this is a must read.

Dr. Fitzpatrick asks a very important question one must consider–if there is such a big disconnect between what the Wakefield papers report and the actual histories of the children (and the disconnects seem to be very significant), shouldn’t the journals print retractions?

Following Brian Deer’s 2004 revelations about Dr Wakefield’s conflicts of interest arising from undisclosed legal aid funding, 10 of his Lancet co-authors retracted the suggestion of a link between MMR and autism (while upholding the paper’s claim to have identified a distinctive form of bowel inflammation in autistic children). It is now clear that, given the selection bias confirmed by Deer – quite apart from his other allegations – it is not possible to make such a claim on the basis of the Lancet cases. Surely it is now time for the authors to withdraw this paper in its entirety? Perhaps the editor of the Lancet – together with those of the other journals involved – could submit Deer’s allegations to some sort of tribunal, perhaps arranged by the Medical Research Council. For 10 years the world of science has witnessed Dr Wakefield’s foolishness; now it has to ask: has he crossed the line into fraud?

Another good source on the Wakefield studies is in Paul Offit’s book “Autism’s False Prophets“.

You may recall that someone has YouTube’d Autism’s False Prophets. Yes, Story Time with Darwin. If you have problems reading or just want to listen in to the sections on Dr. Wakefield, give “Story Time” a try.

There are a LOT of blogs discussing this. I Speak of Dreams is keeping a running list.

Picking a couple–Respectful Insolence has Why am I not surprised? It looks as though Andrew Wakefield probably falsified his data.

Bad Astronomy has Did the founder of the antivax movement fake autism-vaccine link?

It is worth noting that Dr. Wakefield published a statement of his own as In his desperation, Deer gets it wrong once again.

Dr. Wakefield is in a strange position, since the GMC hearings are still ongoing to determine whether his methods warrant disciplinary action. That said, Dr. Wakefield’s statement responds to a letter that Brian Deer sent prior to publication. It is unclear if this response was sent to Mr. Deer before publication, or if any response was made pre-publication. That said, I wonder why Dr. Wakefield didn’t respond to the specific information from the children’s records which contradicts the story presented in Dr. Wakefield’s papers. What Dr. Wakefield does do is offload responsibility to others–other authors and the parents.

The reporting of the children in the Lancet paper is an accurate account of the clinical histories as reported to Professor Walker-Smith and his clinical colleagues.

One comment that has been made to a blog is worth paraphrasing here. Dr. Wakefield comments in his response:

Finally, I did not “create” a scare but rather, I responded to a scare that parents brought to my attention.

Perhaps Dr. Wakefield didn’t “create” a scare. But, what he did was throw gasoline on a lit match. To stand back and claim no responsibility for burning down the house is quite disingenuous.

Wakefield

10 Feb

The name alone conjures up strong images for many in the autism communities. If you think vaccines cause autism, he is a hero. For many others, he has brought shame to the greater autism community.

In addition, I know many who think that Andrew Wakefield’s time has come and gone and we should just ignore him now. To those, I apologize, but the recent information is just too important to ignore.

Kev would be able to show the annoyance that Dr. Wakefield’s research has caused many of us in the autism community. It would be a better read than this–a post written by someone who finds the entire affair sad. Too much harm has been caused by what even before today was already pretty obviously bad science. It’s just a sad story that has just gotten sadder.

For those who may not know, Dr. Andrew Wakefield was the lead author on the papers which attempted to link autism to the MMR vaccine. The story is so long and tortuous that it is difficult to know what to include and what to leave out. You know what, if you don’t already know the story–count yourself lucky and skip this post! How’s that for an introduction?

Brian Deer took a closer look than most (all?) journalists at Dr. Wakefield’s story. He exposed the fact that Dr. Wakefield’s patients were litigants claiming MMR caused autism. He also exposed the fact that Dr. Wakefield and some on his team were well paid for their efforts.

It is very likely that Mr. Deer’s investigation is what prompted the General Medical Council (GMC) to investigate Dr. Wakefield’s actions in this research. As part of that investigation, the GMC has collected medical histories of the subjects of Dr. Wakefield’s study. And, Brian Deer has had access to these data, and they don’t match what was presented by Dr. Wakefield’s team.

Before we look at what was said in the papers and what the medical histories actually indicated, let’s look at the introduction from the original Lancet paper:

We saw several children who, after a period of apparent normality, lost acquired skills, including communication. They all had gastrointestinal symptoms, including abdominal pain, diarrhoea, and bloating and, in some cases, food intolerance. We describe the clinical findings, and gastrointestinal features of these children.

Compare that to what’s here’s Brian Deer’s article, MMR doctor Andrew Wakefield fixed data on autism.

Ouch.

Here’s a more thorough article, again by Mr. Deer:

Hidden records show MMR truth
A Sunday Times investigation has found that altered data was behind the decade-long scare over vaccination

As a short sidetrack, Mr. Deer isn’t the only one suggesting that there were problems with the Wakefield studies.

Wakefield claimed (in a separate paper from the original Lancet article) that his team found evidence of persistent measles virus in gut biopsies from the autistic children he saw. In the Omnibus hearing, a member of Wakefield’s team told the story of how the data which clearly disagreed with Wakefield’s conclusions was ignored.

Or, to put it another way, Dr. Chadwick [note correction] told Dr. Wakefield that he (Bustin) had data which directly contradicted the results Wakefield was going to publish. This should have quashed the paper, and, yet, not mention is even made of it by Wakefield et al.

But, back to the Brian Deer report.

Let’s look at a few examples from Mr. Deer’s story. There were 12 children in the original study. Mr. Deer refers to them as child 1 through child 12. Mr. Deer looks at them individually..

Child 11 had a “positive” test for measles RNA by Wakefield’s team. The father had 3–yes 3!–other labs test the same biopsy samples. Result? No sign of measles.

Here’s a bit about child one from Mr. Deer’s story:

In the paper this claim would be adopted, with Wakefield and his team reporting that Child One’s parents said “behavioural symptoms” started “one week” after he received the MMR.

The boy’s medical records reveal a subtly different story, one familiar to mothers and fathers of autistic children. At the age of 9½ months, 10 weeks before his jab, his mother had become worried that he did not hear properly: the classic first symptom presented by sufferers of autism.

It’s very tempting to quote example after example, but I’ll just end up copying the entire story. I encourage you to read the story, there are numerous examples of how many of the 12 subjects of Wakefield’s study were not previously normal.

Rather than pick all the examples of discrepancies about development of Wakefield’s subjects, how about the second part of the question: did these kids all show GI problems? Again, there are numerous examples in Mr. Deer’s story. Here’s an excerpt.

The most striking change of opinion came in the case of Child Three, a six-year-old from Huyton, Merseyside. He was reported in the journal to be suffering from regressive autism and bowel disease: specifically “acute and chronic nonspecific colitis”. The boy’s hospital discharge summary, however, said there was nothing untoward in his biopsy.

A Royal Free consultant pathologist questioned a draft text of the paper. “I was somewhat concerned with the use of the word ‘colitis’,” Susan Davies, a co-author, told the ongoing GMC inquiry into the ethics of how the children were treated, in September 2007.

“I was concerned that what we had seen in these children was relatively minor.”

Not only are there problems in the reported information and the records, one of the co-authors is indicating that the paper overplayed the data they had.

Sorry, but this all just makes me more sad. Sometimes bad science can be, well a little funny. Sometimes just annoying. This is just really sad.

“A Sunday Times investigation has found that altered data was behind the decade-long scare over vaccination”

What more can be said?

(note: I edited this shortly after publishing it. The substance was not changed)

New thimerosal study, altogether now…

26 Jan

…there’s still no link.

‘Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines‘ is a new study from Italy.

Nearly 70% of the invited subjects participated in the neuropsychological assessment (N = 1403). Among the 24 neuropsychological outcomes that were evaluated, only 2 were significantly associated with thimerosal exposure. Girls with higher thimerosal intake had lower mean scores in the finger-tapping test with the dominant hand and in the Boston Naming Test.

And here’s the conclusion from the penultimate page of the paper (excluding references):

No study conducted to date has been able to provide conclusive evidence of an effect of thimerosal on neuropsychological development. Final judgments regarding this association must rely on the entire body of results from studies conducted in different settings and with different levels of validity and on the coherence of results. The lack of consistency among the results of our study and other available studies suggests that an association between thimerosal exposure through vaccination in infancy and neuropsychological deficits is unlikely or clinically negligible. Additional data from populations with wider ranges of
exposure to thimerosal and additional neuropsychological assessments at older ages may help to clarify the issue of potential associations between thimerosal and neurodevelopmental outcomes.

Oh, and for the conspiracy theorists:

The authors have indicated they have no financial relationships relevant to this article to disclose.

I’m not an epidemiologist so I’m not going to attempt to go through the nuts and bolts of this paper. Hopefully those who have more expertise can go through yet again why this shows that thimerosal in vaccines seems to be about as dangerous as the average housefly. I can’t imagine they really want to. God knows I don’t. But the stupidniks will no doubt need the finer points hammered home again.

Can you sense I’m getting bored with this yet?

← Older Entries
Newer Entries →