Archive | Vaccines RSS feed for this section

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.

It’s time for David Kirby to disavow the autism epidemic

3 Aug

The idea that mercury caused an epidemic of autism is both wrong and very damaging to the autism communities. Many contributed to this damaging notion., but David Kirby without a doubt carries a good quantity of the blame for his book “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” and efforts since.

Mr. Kirby often tries to hide behind the notion that he is just “trying to spark a national debate”. Sorry, but that is nonsense. He actively promotes the idea that vaccines cause autism. It is unclear to this reader whether Mr. Kirby is currently being paid for his efforts. In the past he cherry picked information and packaged it in seemingly self-consistent packages to convince people that an epidemic did occur.

He has now moved to a tag-team approach for presentations to the US congress. He presents information to support the idea that vaccines could cause autism. He then let’s Mr. Mark Blaxill take over to promote the epidemic with the old, tired arguments.

It’s like Mr. Kirby still wants to be able to say, “I never really said there was an epidemic. I was just sparking a discussion.” It’s Mark Blaxill that is actually calling it an epidemic.

Nonsense.

This has been bothering me for some time. It came up again strong when Mr. Kirby commented on a blog piece. David Kirby doesn’t generally participate in the online discussions-even to the point of not answering comments on his own blog pieces. He broke that tradition recently in a blog piece on the Mother Jones website: Breaking: Vaccines still don’t cause autism

My response to Mr. Kirby incorporated much of what I was considering for a future blog post. So, rather than paraphrase what I wrote, here it is in full:

Mr. Kirby,

I see your usual arguments above. I see, also, the usual gaps in your discussion. Over the years, you have gone from promoting the “vaccines caused an epidemic of autism” to dancing around the subject of the false “epidemic”, neither stating that there was an epidemic, nor admitting your mistake. Could you comment somewhere, on the record: was there an “epidemic” of autism caused by mercury? You seem to leave that to your colleague, Mr. Blaxill, giving yourself some form of plausible deniability. It is irresponsible.

You rely heavily now on the NVAC recommendations. Why do you leave out so many comments by NVAC?

The NVAC is assured by the many epidemiological studies of the effects of mercury exposure done in a variety of populations, which have demonstrated that thimerosal in vaccines is not associated with autism spectrum disorders in the general population.

Are you prepared to agree with NVAC that the data are in and that there has been no epidemic of mercury caused autism? It would be the honest thing to do.

You rely heavily on the idea that mitochondrial disorders are related to autism. You pushed heavily on your blog the idea that mitochondrial disorders are caused by mercury, without substantiation. In fact, this idea is strongly rejected by the very experts you rely upon.

Further, you leave it implied that children with mitochondrial disorders and autism indicate a link to autism as a vaccine injury. This is clearly not the case.

Why do you leave out the fact that most children with mitochondrial disorders and autism do not show regression. Without regression, it is clear that vaccine injury is not causing autism in these individuals?

Why do you leave out the fact that in the one study of children with mitochondrial disorders and autism, it is clear that vaccines are not causal in the vast majority of cases, and could be questionable in the one case cited so far?

You cite that there could be a sizable population of autistics who have a mitochondrial dysfunction. Yet you leave out the public statements by one of the very doctors who supported the Hannah Poling case in vaccine court that any such injuries are rare. This from the few doctors who support the idea of mitochondrial disorder as a vaccine injury. Other specialists have stated that it is far to early to draw a conclusion that mitochondrial disorders caused by vaccination is even “rare”.

Why have you not removed your blog piece that was so erroneous that you were forced to rewrite it within a day, with an admission that you seriously erred? Isn’t that a form of dishonesty?

Are you prepared to join Rick Rollens, one of the strongest proponents of the vaccines-cause-autism notion, in stating that the idea that MMR causes autism has been tested and MMR is no longer suspect?

I will ask again, if you are going to cite NVAC, are you willing to join them and state that mercury did not cause an “epidemic” of autism?

Would you at least be willing to include quotes from NVAC that are, shall we say inconvenient, to the notion of a vaccine induced “epidemic” of autism? Quotes such as:

Vaccination almost certainly does not account for the recent rise in ASD diagnoses; however, public concern regarding vaccines and autism coupled with the prevalence and severity of ASD warrant additional study in well defined subpopulations.

This quote makes it clear that
a) NVAC does not support the idea of an autism “epidemic” caused by vaccines
b) NVAC is not calling for studies of vaccines and autism due to evidence presented so far, but, instead, by public concern.

Mr. Kirby, your half truths and misleading arguments cause great harm to the autism communities, as well as to public health. You personally are responsible for much of the public’s misconception that mercury caused an “epidemic” of autism. Don’t you agree that you personally should publicly refute your previous stance?

Being wishy-washy on the epidemic question and letting your colleague Mark Blaxill push the idea in your tag-team briefings is just dishonest. Either you still believe in the mercury-caused-epidemic (and you are wrong) or you should be clear that it was a mistake.

It was a mistake. Earn some respect. Admit it.

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)

Care Clinics and Doctors Data sued

17 Jul

An alternative medicine clinic specializing in autism, Care Clinics of Austin Texas was recently raided by the FBI and the IRS and appears to be shut down.

According to the Quackwatch website In another action, Care Clinics and Doctor’s Data are being sued:

CARE Clinics, of Austin Texas, its owner Kazuko Curtin, its subsidiaries, and Chicago-based Doctor’s Data have been sued for fraud, negligence, and conspiracy

The complaint is being brought by an adult, apparently not autistic, who claims to have been misdiagnosed for heavy metal poisoning. In a step that could have a big impact on the autism alternative-medicine community, the petitioner is charging that the method of testing for heavy metals, specifically that used by Doctors Data, is fraudulent.

It’s worth repeating: it is hard to underestimate the impact of a successful suit against challenge testing to “diagnose” mercury poisoning.

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.

Tags: , ,

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.

Tags: , ,

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.

A vaccinated vs unvaccinated study

6 Jun

For as long as I can recall, this has been one of the clarion calls of the autism/antivaccine/pro-disease groups – that the only way to know if vaccines cause autism is to do a ‘simple’ study of vaccinated vs unvaccinated populations. Indeed, Generation Rescue carried out an ill-fated phone survey that in reality meant absolutely nothing so badly was it put together and carried out. But even if it _had_ been well designed and carried out the results were not good for pro-disease anti-vaccine autism believers:

Number of boys and girls with Aspergers
Unvaccinated: 1% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 2%

Conclusion: you are 1% more likely to have Aspergers if you have been partially vaccinated than unvaccinated. If you are fully vaccinated your chance of being Aspergers is no greater than if you were unvaccinated.

Number of boys and girls with PDDNOS
Unvaccinated: 2% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 1%

Conclusion: you are 1% more likely to have PDDNOS if you are unvaccinated. If you are fully vaccinated your chance of being PDDNOS is 1% less than if you were unvaccinated.

Number of boys and girls with Autism
Unvaccinated: 2% of total
Partially vaccinated: 4% of total
Fully vaccinated: 2%
Fully and Partially combined: 2%

Conclusion: you are 2% more likely to have autism if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is no greater than if you were unvaccinated.

Number of boys and girls with all ASD’s
Unvaccinated: 4% of total
Partially vaccinated: 6% of total
Fully vaccinated: 3%
Fully and Partially combined: 3%

Conclusion: you are 2% more likely to have an ASD if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is 1% less than if you were unvaccinated.

Overall conclusion: the best way to avoid being diagnosed with an ASD is to be fully vaccinated according to the CDC schedule.

And in September of last year, you may recall the announcement of yet another study that demonstrated there was no link between MMR and autism. During the press conference that launched that study David Kirby asked the lead author – Ian Lipkin – what his thoughts were about a vaccinated vs unvaccinated study. His answer was:

http://webjay.org/flash/dark_player

Very difficult if not impossible.

Given that, the US NVAC vaccine safety group released a draft of their latest thinking on the issue of vaccine safety which touched on the idea of doing this sort of study. The entire section related to this is quoted in full below:

Feasibility study of Vaccinated/Unvaccinated/Alternatively Vaccinated Children

Members of the public, stakeholders, and the Interagency Autism Coordinating Committee (IACC) have articulated interest in a study of vaccinated vs. unvaccinated children to determine if there are differences in health outcomes between groups with varying exposures to vaccines. The Working Group considered drafting a recommendation for an IOM review of the science, epidemiology and feasibility of studies of unvaccinated, vaccine delayed, and vaccinated children. The Writing Group Draft Document on Gaps in Research Agenda further developed this idea. The Working Group wishes to clarify several points on this topic. *First, the Working Group believes that the strongest study design, a randomized clinical trial that includes a study arm receiving no vaccine or vaccine not given in accord with the current recommended schedule, is not ethical, would not pass IRB review, and cannot be done*. The type of study that is being suggested would be an observational study of populations looking at natural variation in vaccination schedules including some children where vaccination is declined through parental intent. All children in the study should be recommended to receive the standard immunization schedule. The Working Group endorses the Writing Group’s recommendation for an external expert committee, such as the Institute of Medicine, with broad methodological, design, and ethical expertise to consider “strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs to examine outcomes in unvaccinated, vaccine delayed and vaccinated children and report back to the NVAC.”

The Working Group does not necessarily agree with all of the language in the Writing Group’s statement, but with its general intent. The process should be open and transparent, engaging individuals from a broad range of sectors. Considerations as outlined by the Writing Group and modified by the Working Group are as follows:

– This review should consider strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs and report back to the NVAC

– Consideration should be given to broad biomedical research including laboratory studies, and animal studies.

– Consideration should also be given to study designs comparing children vaccinated by the standard immunization schedule with unvaccinated children (by parental intention), and possibly partially vaccinated children or children vaccinated by alternative immunization schedules

– Outcomes to assess include biomarkers of immunity and metabolic dysfunction, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and other developmental disabilities such as epilepsy, intellectual disability and learning disabilities.

– The inclusion of autism as an outcome is desired. This review should also consider what impact the inclusion of Autism Spectrum Disorders (ASD) as an outcome would have on study designs and feasibility, as referenced in the IACC letter to NVAC.

– This review should be conducted expeditiously, in a transparent manner, and involving broad public and stakeholder input.

So, as per a straight ‘vaccinated vs unvaccinated’ study, Ian Lipkin and NVAC Working Group agree that it can’t be done in the most scientifically accurate way and even if it could, it wouldn’t be ethical due to the requirement of excluding children from vaccination.

What they are saying is that a group like the IOM therefore should write up a feasibility study as to how such a study _could_ be done. Without this, its extremely unlikely that a vax vs unvax study will ever fly.

Amusingly, the way that the NVAC Working Group words a possible solution – vaccinated vs unvaccinated via parental choice – sounds pretty much like the Generation Rescue phone survey. And we know how that ended up.

← Older Entries
Newer Entries →