Archive | Vaccines RSS feed for this section

Conflicts of interest in vaccine safety research

7 Mar

When this abstract came out I had hopes, vain hopes, that it wouldn’t get discussed much online. It’s perfectly reasonable to discuss issues surrounding conflicts of interest in vaccine safety research, but the author has a track record of less-than-excellent publications. Prof. DeLong wrote A positive association found between autism prevalence and childhood vaccination uptake across the U.S. population, which was discussed here at Left Brain/Right Brain, Neuroskeptic and The Biology Files (to name a few). Again, not an excellent study.

Here is the abstract of the new paper:

Conflicts of interest (COIs) cloud vaccine safety research. Sponsors of research have competing interests that may impede the objective study of vaccine side effects. Vaccine manufacturers, health officials, and medical journals may have financial and bureaucratic reasons for not wanting to acknowledge the risks of vaccines. Conversely, some advocacy groups may have legislative and financial reasons to sponsor research that finds risks in vaccines. Using the vaccine-autism debate as an illustration, this article details the conflicts of interest each of these groups faces, outlines the current state of vaccine safety research, and suggests remedies to address COIs. Minimizing COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program.

The introduction to the paper starts with “How safe are vaccines?” This for a paper whose purported subject is “Conflicts of interest in vaccine safety research”.

I was going to put off reading the paper until I found this line in Orac’s article on it. Prof. DeLong, former board member of SafeMinds, wrote about “advocacy groups” (which includes SafeMinds, NVIC and the Autism Research Institute) thus:

While these organizations are not as well-staffed or well-funded as government agencies or vaccine manufacturers, their main task is to generate information to refute agency or industry claims.

We hear over and over how these groups have the focus to provide accurate information, to allow for “informed consent”. But here we find that they are focused on generating “..information to refute [government] agency or industry claims.”

Which begs the question: what if/when the information from the government or industry is correct? Prof. DeLong appears to be assuming that the information is always in need of refutation. Not exactly what I want for in an “advocacy group”.

Which brings us to another point: why are “advocacy groups” only those who are in the business of “refuting” government and industry information? What about advocacy groups such as the Sabin Vaccine Institute, the Bill and Melinda Gates Foundation, CHOP’s Vaccine Education Center, Every Child by Two, to name a few. I know many vaccine skeptics dismiss these groups as “front groups” for the government or industry, which is a particularly hard argument to make for the Gates Foundation.

Prof. DeLong makes a passing attempt to include conflicts of interest for the advocacy groups she does include. I say “passing attempt” because while much of the paper is devoted to methods whereby public health decisions should be made without influence of COI’s, she only makes these suggestions for people from industry or government. For example, she says that we should “manage the influence of vaccine manufacturers on medical journals”. No mention of, say, Andrew Wakefield serving on the editorial board of “Autism Insights” when a paper supporting him was published by one of his employees. Or for less severe questionable activities such as people funded by “advocacy groups” serving as referees or editors of journals. She also has a section on how we should “prohibit agencies that promote vaccines from overseeing vaccine safety”. But no prohibition for members of “advocacy groups” which often include, as in her case, people who have filed claims in the vaccine court and are, thus, facing a significant financial COI.

Much of the paper is basically a Trojan Horse. Under the title of “Conflicts of interest in vaccine safety research”, the paper spends considerable space discussing vaccine safety (remember that first sentence of the paper?). We are left with the premise that “trust in vaccine safety is low”. Those two paragraphs are a good example of selective quoting of statistics. For example, we are told that 77% of people surveyed have at least one concern about vaccine safety. Count me in. Am I an example of “low trust” in vaccine safety? “Low” is a relative word. A counter example to those given in the paper: vaccine uptake is still about 90% (and more) for most childhood vaccines. People watching these numbers are concerned with fractions of a percent drop. “Low” is “low enough to potentially endanger public health by allowing for outbreaks”. That’s my definition of low. Not the implied, most people have low trust.

The paper is about 25 pages long, in published format. That’s a big effort. It is, in the end, largely a very long blog post. If you’ve been reading the online discussions for the past few years, you’ve likely encountered much of what she has to say. It ends up more of an opinion piece than a scientific paper.

Walker-Smith wins appeal

7 Mar

Prof. John Walker-Smith was one of Andrew Wakefield’s colleagues at the Royal Free and participated in the research there. Prof. Walker-Smith was struck off the medical register along with Andrew Wakefield by the General Medical Council. Prof. Walker-Smith appealed and the GMC’s decision has been quashed.

Here is the conclusion of the appeal decision:

For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel’s overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion. Miss Glynn submits that the materials which I have been invited to consider would support many of the panel’s critical findings; and that I can safely infer that, without saying so, it preferred the evidence of the GMC’s experts, principally Professor Booth, to that given by Professor Walker-Smith and Dr. Murch and by Dr. Miller and Dr. Thomas. Even if it were permissible to perform such an exercise, which I doubt, it would not permit me to rescue the panel’s findings. As I have explained, the medical records provide an equivocal answer to most of the questions which the panel had to decide. The panel had no alternative but to decide whether Professor Walker-Smith had told the truth to it and to his colleagues, contemporaneously. The GMC’s approach to the fundamental issues in the case led it to believe that that was not necessary – an error from which many of the subsequent weaknesses in the panel’s determination flowed. It had to decide what Professor Walker-Smith thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions fell outside the spectrum of that which would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question is an error which goes to the root of its determination.

The panel’s determination cannot stand. I therefore quash it. Miss Glynn, on the basis of sensible instructions, does not invite me to remit it to a fresh Fitness to Practice panel for redetermination. The end result is that the finding of serious professional misconduct and the sanction of erasure are both quashed.

From The Telegraph’s MMR doctor wins battle against being struck off:

A doctor found guilty of serious professional misconduct over the MMR controversy has won his High Court appeal against being struck off.

And:

Chief executive Niall Dickson added: “Today’s ruling does not however reopen the debate about the MMR vaccine and autism.

“As Mr Justice Mitting observed in his judgement, ‘There is now no respectable body of opinion which supports (Dr Wakefield’s) hypothesis, that MMR vaccine and autism/enterocolitis are causally linked’.

Vaccine skeptic propogates harmful autism stereotypes…again

29 Feb

A major news story in the U.S. right now involves a school shooting incident in Ohio. Somehow when school shootings happen, someone always seems to float the speculation that the shooter is/was autistic. It’s happening again with people pointing to this article on
the Cafe Mom website:

40 Infallible Reasons Why You Should Not Vaccinate Infants

By Jagannath Chatterjee (Fighting Vaccines Since 1985)
August 30, 2008

“Fighting vaccines since 1985″….

The 40 “infallible reasons” include this one:

23. Autism is a permanent disability that affects the child physically, mentally and emotionally. It makes the child loose social contact. It impedes both the physical and mental growth of the child. It destroys the brain causing severe memory and attention problems. According to vaccine researcher Dr Harris Coulter, vaccines cause children to become pervert and criminal. All the school shootings by the children in the USA are by autistic children. Vaccines can cause more harm that even the medical community privately acknowledges.

Readers will likely not be surprised to read that Dr. Coulter is not a medical doctor.

Such statements as those above generally don’t need comment to anyone who has even a cursory knowledge of the facts. If I had made that statement up people would accuse me of going over-the-top in parody.

This isn’t a time for “generally”. We have a recent school shooting case in the U.S.. And we have people pointing to this article as part of that discussion. The logical train of vaccines cause autism which causes people to be “pervert and criminal” which leads to school shootings.

It’s worth noting that both Harris Coulter and Jagannath Chatterjee are featured favorably on the site Whale.to. For those who consider that to be an ad-hominem attack I’d ask: against who? Whale.to or Coulter and Chatterjee? Neither looks good in association with the other.

Mark Geier: Cease and Desist

26 Feb

From the Baltimore Sun: ‘Cease and desist’ order issued against autism doctor

Dr. Mark R. Geier, a Rockville doctor accused of improperly treating children with autism, has been ordered by the state Board of Physicians to stop practicing medicine while his license is suspended.

The doctor’s license was suspended in April after the board concluded his hormone and chelation therapy endangered the children in his care. But the board in a new “cease and desist” order this week accused the doctor of refilling prescriptions for at least three patients in violation of the suspension.

The doctor has appealed the suspension of his license. His lawyer declined to comment on the newest claims.

Cochrane Reports: Vaccines for measles, mumps and rubella in children (Review)

22 Feb

The Cochrane collaboration has put out an updated report on the MMR vaccine.

Online discussions (for example, here) are (a) focused on the abstract only so far and (b) centered on two lines from the abstract:

Exposure to the MMR vaccine was unlikely to be associated with autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn’s disease, demyelinating diseases, bacterial or viral infections

and

The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate

Here is the full abstract from the paper:

Background
Mumps, measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness, disability and death. However, public
debate over the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists, despite its almost universal use and accepted effectiveness.

Objectives
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age.

Search methods
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2),
which includes the Cochrane Acute Respiratory Infections Group’s Specialised Register, PubMed (July 2004 to May week 2, 2011)
and Embase.com (July 2004 to May 2011).

Selection criteria
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo, do nothing or a combination of measles, mumps and rubella antigens on healthy individuals up to 15 years of age.

Data collection and analysis
Two review authors independently extracted data and assessed methodological quality of the included studies. One review author
arbitrated in case of disagreement.

Main results
We included five randomised controlled trials (RCTs), one controlled clinical trial (CCT), 27 cohort studies, 17 case-control studies, five time-series trials, one case cross-over trial, two ecological studies, six self controlled case series studies involving in all about 14,700,000 children and assessing effectiveness and safety of MMR vaccine. Based on the available evidence, one MMR vaccine dose is at least 95% effective in preventing clinical measles and 92% effective in preventing secondary cases among household contacts.
Effectiveness of at least one dose of MMR in preventing clinical mumps in children is estimated to be between 69% and 81% for the
vaccine prepared with Jeryl Lynn mumps strain and between 70% and 75% for the vaccine containing the Urabe strain. Vaccination
with MMR containing the Urabe strain has demonstrated to be 73% effective in preventing secondary mumps cases. Effectiveness of
Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children and adolescents was estimated to be between
64% to 66% for one dose and 83% to 88% for two vaccine doses. We did not identify any studies assessing the effectiveness of MMR in preventing rubella.

The highest risk of association with aseptic meningitis was observed within the third week after immunisation with Urabe-containing
MMR (risk ratio (RR) 14.28; 95% confidence interval (CI) from 7.93 to 25.71) and within the third (RR 22.5; 95% CI 11.8 to
42.9) or fifth (RR 15.6; 95% CI 10.3 to 24.2) weeks after immunisation with the vaccine prepared with the Leningrad-Zagreb strain.
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 1.10; 95% CI 1.05 to
1.15) was assessed in one large person-time cohort study involving 537,171 children aged between three months and five year of age. Increased risk of febrile seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 4.09; 95% CI 3.1 to 5.33) and children aged 12 to 35 months (RI 5.68; 95% CI 2.31 to 13.97) within six to 11 days after exposure to MMR vaccine. An increased risk of thrombocytopenic purpura within six weeks after MMR immunisation in children aged 12 to 23 months was assessed in one case-control study (RR 6.3; 95% CI 1.3 to 30.1) and in one small self controlled case series (incidence rate ratio (IRR) 5.38; 95% CI 2.72 to 10.62). Increased risk of thrombocytopenic purpura within six weeks after MMR exposure was also assessed in one other case-control study involving 2311 children and adolescents between one month and 18 years (odds ratio (OR) 2.4; 95% CI 1.2 to 4.7). Exposure to the MMR vaccine was unlikely to be associated with autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn’s disease, demyelinating diseases, bacterial or viral infections.

Authors’ conclusions
The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The
evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target
diseases.

The body of the paper summarizes the accepted papers and judges papers on criteria such as potential for bias and generalizability.

While much discussion online is given to the short abstract available in pubmed, consider the last three sections of the paper.

First, “Agreements and disagreements with other studies or reviews”

Agreements and disagreements with other studies or reviews
Currently, this is the only review covering both effectiveness and safety issues ofMMR vaccines. In agreement with results from other studies and reviews a significant association between autism and MMR exposurewas not found.The study of Wakefield (Wakefield 1998), linking MMR vaccination with autism, has been recently fully retracted (The Editors of The Lancet 2010) as Dr.Wakefield has been found guilty of ethical,medical and scientific misconduct in the publication of the paper; many other authors have moreover demonstrated that his data were fraudulent (Flaherty 2011). A formal retraction of the interpretation that there was a causal link between MMR vaccine and autism has already been issued in year 2004 by 10 out of the 12 original co-authors (Murch 2004). At that time (1998) an excessive and unjustified media coverage of this small study had disastrous consequences (Flaherty 2011; Hilton 2007; Offit 2003; Smith 2008), such as distrust of public health vaccination programmes, suspicion about vaccine safety, with a consequential significant decrease in MMR-vaccine coverage and re-emergence of measles in the UK.

Let’s look at the “Authors Conclusions” section at the end the paper:

AUTHORS’ CONCLUSIONS

This is in two sections:

first:

Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication and in order to reduce morbidity and mortality associated with mumps and rubella.

Repeat for emphasis: Existing evidence supports the current policies of mass immunisation.

This is followed by “implications for research”:

Implications for research
The design and reporting of safety outcomes in MMR vaccine studies, both pre and post-marketing, need to be improved and standardised definitions of adverse events should be adopted. More evidence assessing whether the protective effect of MMR could wane with the time since immunisation should be addressed.

At this point I’ll point out what I see as a false dichotomy. The discussion is not between “should vaccination continue” and “are the studies adequate” as some have framed it. Clearly Cochrane has called for both continued immunization *and* more research. This includes research into “assessing whether the protective effect of MMR could wane with the time since immunisation”, something which could point to the need for booster shots.

How about the MMR/autism question?

First off, let’s note that four of Mr. Wakefield’s papers were considered for the review. All four were rejected.

Wakefield 1998 {published data only}
Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al.Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998;351(9103):637–41.

Wakefield 1999a {published data only}
Wakefield AJ, Montgomery SM. Autism, viral infection and measles-mumps-rubella vaccination. Israel Medical
Association Journal 1999;1(3):183–7.

Wakefield 1999b {published data only}
Wakefield AJ. MMR vaccination and autism. Lancet 1999; 354(9182):949–50.

Wakefield 2000 {published data only}
Wakefield AJ, Montgomery SM. Measles, mumps, rubella vaccine: through a glass, darkly. Adverse Drug Reactions and
Toxicological Reviews 2000;19(4):265-83; discussion 284- 92.

Oddly, while the body of the Cochrane review notes that Wakefield 1998 has been retracted, the citation does not. The paper should either not be cited (as it has been effectively erased from the public record) or the citation should include the term “retracted”. The retraction is not the given reason for rejecting the study from the review. It was rejected due to being a case series. Wakefield 1999a and was rejected for lack of comparative data while Wakefield 1999b because it has no data.

As already quoted above, the authors of the Cochrane review *do* take notice of the GMC hearing and the Lancet retraction:

“The study of Wakefield (Wakefield 1998), linking MMR vaccination with autism, has been recently fully retracted (The Editors of The Lancet 2010) as Dr. Wakefield has been found guilty of ethical,medical and scientific misconduct in the publication of the paper; many other authors have moreover demonstrated that his data were fraudulent (Flaherty 2011).”

I note the statement that “many other authors have moreover demonstrated that his data were fraudulent ” First, the Cochrane Report is reporting that the data have been “demonstrated” to be fraudelent. Further, not “The BMJ” have claimed that the data were fraudulent, but “many other authors”.

In what I see as a strange move, the Hornig study (Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.) was not considered by Cochrane with the given reason “Subjects affected by gastrointestinal disturbance”. Hornig et al. was the most on-target attempt to reproduce multiple critical aspects of Mr. Wakefield’s work.

What studies *were* included? Here’s the list, together with how Cochrane rated them for “risk of bias” and “generalisability”
Madsen 2002 moderate/high
Fombonne 2001 high/low
Uchiyama 2007 high/low
Smeeth 2004 moderate/medium
DeStefano 2004 moderate/medium
Mrozek-Budzyn 2010 moderate/medium
Fombonne 2006 moderate/medium
Honda 2005 moderate/medium
Makela 2002 moderate/medium
Taylor 1999 moderate/medium

To close, I’ll repeat the “implications for practice”:

Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication and in order to reduce morbidity and mortality associated with mumps and rubella.

Severe Influenza Among Children and Young Adults with Neurologic and Neurodevelopmental Conditions — Ohio, 2011

17 Feb

Children with neurologic and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. Those aren’t my words. They are the first sentence in a new report by the CDC: Severe Influenza Among Children and Young Adults with Neurologic and Neurodevelopmental Conditions — Ohio, 2011.

Individuals with developmental disabilities are at a higher risk of harm or death from infectious diseases. They are also often more difficult to diagnose due to many factors including difficulties with communication.

The residents included a high percentage of individuals with great challenges. For example, of those with severe infections, nine had “do not resuscitate” orders (the reasons for this is not given).

All 13 residents with severe influenza had severe to profound neurologic and neurodevelopmental disabilities, including physical limitations (e.g., scoliosis, hemiplegia or quadriplegia, or cerebral palsy) (Table 1), and nine had “do not resuscitate” orders.

The story from this Ohio facility is bad on many fronts. An outbreak of influenza swept through the facility. 130 residents total. 76 residents had acute onset of respiratory illness. 13 were severely ill. 10 were hospitalized, and seven died.

All of those severely ill had the influenza vaccine. However, during the investigation it was found that the refrigerator that stored the vaccines was 27 degrees F. If the same temperature was in effect while the vaccines were stored, the low temperature could have inactivated the vaccine.

In other words, these individuals were given vaccines but they could have been rendered useless by the storage conditions.

Here is the abstract:

Children with neurologic and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. In April 2011, the Ohio Department of Health and CDC investigated an influenza outbreak that began in February 2011 in a residential facility for 130 children and young adults with neurologic and neurodevelopmental conditions. This report summarizes the characteristics and clinical courses of 13 severely ill residents with suspected or confirmed influenza; 10 were hospitalized, and seven died. Diagnosis is challenging in this population, and clinicians should consider influenza in patients with neurologic and neurodevelopmental conditions who have respiratory illness or a decline in baseline medical status when influenza is circulating in the community. Prompt testing, early and aggressive antiviral treatment, and antiviral chemoprophylaxis are important for these patients. When influenza is suspected, antiviral treatment should be given as soon as possible after symptom onset, ideally within 48 hours. Treatment should not wait for laboratory confirmation of influenza. During outbreaks, antiviral chemoprophylaxis should be provided to all residents of institutional facilities (e.g., nursing homes and long-term- care facilities), regardless of vaccination status. Residential facilities for patients with neurologic and neurodevelopmental conditions are encouraged to vaccinate all eligible residents and staff members against influenza.

The story notes the relatively low efficacy of the influenza vaccine (about 60%). If the vaccines were compromised by low temperature storage, 60% efficacy could have saved 4 of the seven people. So called “vaccine safety” groups should be calling for more effective vaccines, not downplaying the need for vaccines using the 60% figure.

What are the take-away messages from this? For one, influenza *is* a serious disease. Especially to many in the disability community.

A Comparison of Urinary Mercury between Children with Autism Spectrum Disorders and Control Children

16 Feb

Researchers are still looking at the question of whether autism is caused by mercury intoxication. One of the measures used in the past is to check the mercury content in the urine of autistic and non autistic children. Claims have been made that autistic children are “poor excretors” of mercury. This is defined as “more mercury in the urine than other children” or “less mercury in the urine of other children”.

A group of researchers from the UK and US have tested a group of autistic children, special needs non autistic children, siblings and regular school children. What did they find? No difference.

Background

Urinary mercury concentrations are used in research exploring mercury exposure. Some theorists have proposed that autism is caused by mercury toxicity. We set out to test whether mercury concentrations in the urine of children with autism were significantly increased or decreased compared to controls or siblings.

Methods

Blinded cohort analyses were carried out on the urine of 56 children with autism spectrum disorders (ASD) compared to their siblings (n = 42) and a control sample of children without ASD in mainstream (n = 121) and special schools (n = 34).
Results

There were no statistically significant differences in creatinine levels, in uncorrected urinary mercury levels or in levels of mercury corrected for creatinine, whether or not the analysis is controlled for age, gender and amalgam fillings.

Conclusions

This study lends no support for the hypothesis of differences in urinary mercury excretion in children with autism compared to other groups. Some of the results, however, do suggest further research in the area may be warranted to replicate this in a larger group and with clear measurement of potential confounding factors.

There were outliers of high mercury content in the special needs children (both autistic and non autistic). Expect those promoting the autism/mercury connection to focus on those children and to build connections between the funding agencies and pharmaceutical companies.

Attorney for Prof. Walker-Smith: alleged link between MMR and autism utterly disproved

14 Feb

Prof. John Walker-Smith was a colleague of Andrew Wakefield, a co-author on the no-retracted 1998 Lancet paper and shared the same fate as Mr. Wakefield after the General Medical Council Hearings: he was struck off the medical register. Prof. Walker-Smith has appealed (Mr. Wakefield did not). A few news stories have come up about this appeal. In Doctor struck off over MMR controversy appeals against ruling, the Guardian notes:

Prof John Walker-Smith tells high court he was denied a fair hearing before he was struck off by the General Medical Council

Many are looking to this appeal for vindication of Mr. Wakefield and his theories on MMR being linked to and causal in autism. Prof. Walker-Smith’s attorney appears to have made a rather clear statement to the contrary:

Miller said it had been important that the disciplinary panel “separate out research from the clinical medicine – but that was a task that appeared to be beyond them”.

The judge asked Miller whether the alleged link between MMR and the vaccine “has now been utterly disproved” in the opinion of “respectable medical opinion”.

Miller said that was “exactly” the position.

edit to add:

I took the statement “The judge asked Miller whether the alleged link between MMR and the vaccine “has now been utterly disproved” ” to be a mistaken report by the Guardian because, as written, it does not make sense. My own interpretation was that the actual question was whether the MMR and *autism* was the point. However, I should have made that assumption very clear in the above piece and I apologize for that. I have written the paper as well as some other people who might be able to clarify the statement.

Sharyl Attkisson to receive media award

8 Feb

Sharyl Attkisson has been one of the less reliable members of the media when it comes to the autism/vaccine discussion. She promotes the purported link, defended Andrew Wakefield and gave David Kirby (of Evidence of Harm fame) a platform to promote his views.

For example. Recall a few years back when the Hornig study (Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study) came out definitively putting to rest the idea that MMR causes autistic regression/GI disease with persistent measles measles infection. Ms. Attkisson wrote a piece, New Study Disproves Vaccine/MMR/Autism Link.

But she didn’t write about the new study or how it disproves the MMR/autism link.

There’s a new study in the Public Library of Science regarding vaccine measles and autism which purports to disprove a vaccine/MMR/autism link.

Also, researchers at ThoughtfulHouse wrote an opposing analysis:

She didn’t discuss the study at all. Instead she linked to printed a press release by (then) Andrew Wakefield’s Thoughtful House.

Readers won’t be surprised that I was dismayed to read that she’s now getting an award. From “Accuracy in Media“, to be given out at the Conservative Political Action Conference.

Dismayed that is until I saw what “Accuracy” in Media has as a track record.

Here’s a particularly egregious example of an article from an “Accuracy in Media” “report“:

Repealing the ban on open homosexuals serving in the U.S. military would be a mistake of historic proportions but the mainstream media are turning a blind eye.

The intro is bad enough. The discussion worse. Why? Well, the author of that hate piece is

Dr. Scott Lively, a Massachusetts attorney and pastor, is co-author, along with Kevin E. Abrams, of The Pink Swastika: Homosexuality in the Nazi Party.

Yes. The Nazis were gay. How does the saying go, you can’t parody a farce? Read more examples of AIM’s “accuracy”in CBS To Receive Award From Fringe Group At CPAC. With links to AIM’s support of the Birthers and other outlandish claims against President Obama.

Well, this farcical organization is going to “honor” Sharyl Attkisson. I guess there is something worse than getting a “Gallileo” award from the Age of Autism.

Transcripts from the GMC hearings

2 Feb

With the defamation suit by Mr. Wakefield filed in Texas there is the strong possibility that the discussions will ensue again about what actually happened during Mr. Wakefield’s research at the Royal Free hospital. The one record of this is in the transcripts for the GMC hearings. These can be found online in a few places (casewatch and Sheldon 101’s blog Vaccines Work, for example). These are useful resources but somewhat cumbersome. Most people are not going to download a file to check a quote in context. And context can be very important, as we’ve seen here on Left Brain/ Right Brain where previous discussions by Mr. Wakefield’s supporters often involved pulling quotes out of context.

I don’t want to clutter this site with the transcripts, but I do want them in a place where internet search engines can find them and people can easily link and check quotes. So I am now uploading them to a new blog. It should take a few days to get the transcripts online in this format. About 30 days worth are up now.

In doing so I re-read some of the pages. One of the best examples of what happened is covered on Day 28. This is the day when the mother of Child 12 (last of the 12 children in the Lancet study) testified.

This one day’s testimony addresses many of the discussion topics which come up repeatedly in online discussions:

1) Parents of the Lancet Children were not prevented from testifying at the GMC.

2) She was the only one who did testify. She was the only one called by the GMC. The defense appears to have not called any of the parents.

3) Mr. Wakefield’s attorney declined the opportunity to even cross examine this parent.

4) The idea that Mr. Wakefield only reported what parents told him isn’t well supported by the evidence. Rather, there is a very circular route for the idea that the MMR causes autism. Mr. Wakefield and Mr. Barr (the attorney working on the litigation) were in contact with this parent multiple times before the child was seen at the Royal Free.

5) Some of the children in the Lancet study were registered with Legal Aid at the time of the study, and well before the Lancet paper was published.

6) The idea that the children were referred through normal channels is not accurate. While this child was referred through general practitioners, there was much contact between the mother, Mr. Wakefield and the attorney before that. One letter from the attorney makes it clear that they expressly told the parents to be sure to get the GP referral.

7) The idea that this work was not a research study isn’t really accurate. Mrs. 12 repeatedly gives her impression that they were involved in a research study.

Yes, this has all been covered before. Unfortunately, I fear this will all be covered repeatedly as this new case works its way through the court.

With that, here are some excerpts from the Day 28 testimony. Which you can check in context.

Q I think it is right that at around the same time, as well as that contact with Dr Wakefield, did you also have some contact with a firm of solicitors called Dawbarns?
A Yes, that is right.

Q Can you tell us how that came about. Why did you get in touch with them?
A The same mother told me about them as well.

Q What was your understanding of what they were doing?
A They were trying to really put a stop to the MMR vaccine being used and obviously to stop any damage that was being done to children.

Emphasis added. Mrs. 12 thought that Dawbarns “were trying to really put a stop to the MMR vaccine being used”.

After contacting the lawyers, she received a letter. This is dated 18 July 1996. Her son wasn’t seen at the Royal Free until 18 October, 1996, three months later:

“Dear [Mrs 12],

Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hunt Dickens of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the Government’s measles/rubella vaccination campaign in the autumn of 1994.

To give you an idea of our work I enclose an information pack which consists of a copy of a fact sheet which we have produced on the MMR vaccine and a fact sheet on ourselves.

We have built up a considerable volume of evidence that vaccines can cause injury to children, and we are hoping to take compensation claims to court. See the fact sheets for more information. Legal Aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects. In claims being brought on behalf of children the Legal Aid Office does not take into account the finances of the parents, but there are sometimes difficulties in obtaining legal aid …”

She was supplied with a “fact sheet” written by Mr. Wakefield. No contamination of the study there, right? In the Lancet he’s just reporting what the parents told him. No mention of the issue of the parents being supplied with a “fact sheet” to guide them.

Richard Barr (the attorney managing the litigation effort and teamed with Andrew Wakefield) wrote her on 14 August 1996

“We are also in touch with other experts and together they are hoping to establish a link between the vaccine, inflammatory bowel disease and autism. There is a clear cut biological mechanism for linking the two conditions. I suggest it might be worth your while to contact Dr Wakefield. If you would like me to do so I will be happy to make the introduction for you. May I have permission to send him a copy of the statement that I have prepared for [Child 12]?”

They are hoping to establish a link and “there is a clear cut biological mechanism for linking the two conditions [bowel disease and autism]”. Two months before being seen at the Royal Free she is informed about the effort to link MMR with autism and bowel disease and the idea that autism and bowel disease are linked.

Clearly any study reporting “what the parents told us” is contaminated at this point.

If you think the study could be salvaged, even with this level of contamination, here is a discussion of the fact sheet supplied to the parents as mentioned above:

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Inflammatory Bowel Disease, measles virus and measles vaccination.

What is inflammatory Bowel Disease (IBD)?

IBD comprises 2 conditions that have many similarities. Crohn’s disease and ulcerative colitis. Crohn’s disease may affect any part of the bowel, from mouth to anus, whereas ulcerative colitis affects the large bowel only. Many people now believe that these two conditions are part of a single spectrum of intestinal disease. IBD is often difficult to diagnose in children, especially Crohn’s disease, and this may lead to a delay in diagnosis with frustration for parents, doctors and, in particular, the affected children.

What is the link with measles and measles vaccine?

Measles virus was put forward as a possible cause of Crohn’s disease in 1989. The dramatic rise in the incidence of inflammatory bowel disease in developed countries over the last 30 years, in the face of live measles vaccination, also suggested a link between the vaccine and the disease.

Several groups from around the world have now identified measles virus in tissues affected by Crohn’s disease and an immune response to measles virus in the blood of patients with Crohn’s disease and ulcerative colitis. Early exposure to measles virus appears to be a major risk factor for developing Crohn’s disease later in life, and one study recently linked live measles vaccine to both Crohn’s disease and ulcerative colitis. Several new studies are currently underway that are designed to clarify the association between measles vaccination and inflammatory bowel disease. Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.

Then the fact sheet sets out what you would look for (and what you should do: contact Andrew Wakefield):

Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,

“Crohn’s disease. The symptoms and signs of Crohn’s disease in childhood are often insidious and non-specific and may lead to a delay in diagnosis. Intestinal symptoms include mouth ulcers, cramping abdominal pains, loss of appetite, diarrhoea with or without blood and problems in the anal region, including skin tags, tears or abscess formation. However, children commonly present with weight loss and failure to thrive as the only indications that they may have Crohn’s disease. But be aware, unexplained joint paints, sore eyes and skin rashes can also be the presenting symptoms of Crohn’s disease.

Ulcerative colitis is often more clear-cut, with diarrhoea, urgency and blood and mucus mixed in with the stools. Again, growth failure and symptoms such as joint pain may precede the intestinal problems.

What should we do?

If you suspect that your child has inflammatory bowel disease, prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”,

A document by Wakefield, possibly from the Royal Free says that there is a link between Crohn’s disease and the measles vaccine. This given to prospective study subjects before being seen at the Royal Free. But no contamination of the study subjects again, right?

Child 12 was registered with Legal Aid before in August, two months before being seen by the Royal Free:

Q Also enclosed with that letter of 14 August 1996 were the legal aid forms. I think that is right. Did you fill in the legal aid forms in order for an application to be made for your child to be legally aided?
A Yes.

One issue that Mr. Wakefield has brought up in recent years is the concern over vaccines containing the Urabe strain of mumps. Mr. Wakefield has gone into detail about how he was informed by a “whistleblower” about how the government handled the licensure of those vaccines. Mr. Wakefield had those discussions with the whistleblower in 1999 but appears to have done little with the information until the past few years. Why? Perhaps this comment by his colleague Richard Barr will shed some light onto this: “Although Immravax and Pluservix were withdrawn on safety grounds, the particular problem they caused was fairly limited. ” It was the opinion of Mr. Barr at the time that the Urabe strain mumps concerns with some of the MMR vaccines was “fairly limited”. Mr. Barr and Mr. Wakefield, of course, had a different avenue to pursue: the measles/gut disease/autism hypothesis.

In Sept. 1996, Barr sent Mrs. 12 a newsletter:

Under the heading, “Pilot study”,

“If we can prove a clear link between the vaccines and autism/inflammatory bowel disease this will be exceedingly useful, not only for cases involving those conditions, but also for other types of damage such as epilepsy.

To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free Hospital in London. We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests to be carried out by a number of leading experts in their fields. We will of course be liaising closely with the families concerned and the doctors will be giving very full details of what will be involved”.

Need I point it out again? Before even arriving at the Royal Free, Mrs. 12 was informed about the need to provide a clear link between vaccines and autism/bowel disease.

Q We have heard from the Dawbarns newsletter that I read to you previously that as far as the solicitors were concerned there was a pilot study being arranged. Did you have any understanding or awareness whether your little boy was a part of that pilot study at all?
A He was referred to Dr Wakefield by my GP for investigations, which I understood to be research investigations, but that was the route he was referred.

She felt that her child was being referred for “research investigations”

Mr. Wakefield is keen to tell everyone that the referrals came through the GP’s. He doesn’t mention that he and Mr. Barr made sure ahead of time that they went through the GP’s:

“Dear Mrs [12]

Many thanks for your letter of 10 September 1996. I will contact some other parents in your area and if they agree then you can all swap names and addresses. It is interesting how isolated people feel (and sometimes are!).

I would like to see the records. These may well be helpful if we have any difficulties over legal aid. At the moment I am still waiting to hear from them.”

So that was the end of the correspondence, and I now want to ask you about the actual referral, which you have explained to us was through your GP to the Royal Free Hospital in respect of your boy. We have been through this already, but just to remind you, if you go back to the GP records, please, page 126, this is a letter that I asked you about when I first began to question you, Mrs 12, the letter from Dr Wakefield, and we see in that the suggestion that you in fact you should go to your GP for a referral. Did you do that?

Emphasis added.

On admission to the Royal Free:

Q “Soils – not had diarrhoea. Has variable abdominal pain”, and then I cannot read the rest of that sentence. Mr Miller is trying to assist me – “occurring every week”. Thank you. “Mother had not associated vaccination with his problems until met a parents support group”. Does that set out the problem as far as his gastrointestinal symptoms were concerned, I mean obviously in brief terms?
A Yes.

“Mother had not associated vaccination with his problems until met a parents support group”. Earlier in the transcript it is noted that this parent group included the mother of Child 6 and 7 and this is where Mrs. 12 was put in touch with Mr. Barr and Mr. Wakefield.

After her son was seen at the Royal Free, here’s the letter Mrs. 12 wrote. Note that she read the proposed “clinical and scientific study notes”. But this was just a routine referral, right?

“Dear Professor Walker-Smith,

I am writing following [Child 12’s] visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also re-read Dr Wakefield’s proposed clinical and scientific study notes.

We do feel that [Child 12] does have a problem in that most children of his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose, which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.

Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [Child 12] is not growing or putting on weight like my other two children.

I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [Child 12] but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.

I do hope to hear from you in due course.”

In a letter to Mr. Wakefield she notes:

“Finally, I would like to say how nice it was to meet you at the JABS open meeting on 4 October in London. I found your short discourse both informative and interesting. I wish you all the best with your research.”

Yes, Wakefield was lecturing at JABS (an organization focused on vaccine injury) meetings. Mrs. 12 attended. This is Oct. 4, two weeks before her child was seen at the Royal Free.

Once again, we are in the merry-go-round. Mr. Wakefield only reported what the parents told him, except that here we have a clear example of a parent hearing from Mr. Wakefield on more than one occasion about what he was investigating.

The first visit to the Royal Free was not with Mr. Wakefield (Mr. Wakefield did not have clinical duties). Child 12 wasn’t even going to be referred to Mr. Wakefield at first:

Q So that was from your point of view, but you say in your letter to Dr Wakefield, Professor Walker-Smith’s main reasons for not referring [Child 12] on to Dr Wakefield was the absence of blood in the faeces and the lack of diarrhoea, you were saying that is what Professor Walker-Smith’s view was, is that correct?
A Yes.

But a blood test was “slightly abnormal” so they did make the referral.

“Dear [Mrs 12],

I do apologise for the delay in replying to your letter of 28 November. The slight abnormality that you referred to in your letter was that one of the markers of inflammation was just slightly above the normal range, it just means that we should go ahead. I understand that [Child 12] is coming in in the New Year to have a colonoscopy.”

A “slight abnormality” was enough to warrant a colonoscopy. Oddly enough, a later letter states that the blood tests were not abnormal.

The psychiatrist was not very clear on autism diagnosis:

Q If you to go page 18 in the medical records, we have a note dated 10 January, and in fact we have heard some evidence from Dr Berelowitz and he has given evidence in relation to all the children, including your son, and it was his evidence that this was his note, and we see at the bottom a diagnosis of “language delay ? [attention deficit disorder]” and then “? Asperger’s”: do you have any recollection of that?

The Royal Free didn’t think child 12 should have an MRI or a lumbar puncture.

Q If we go back to the Royal Free records – you can put FTP7 away, you will not need it again – at page 21 – it is on 6 January, so the day after the admission – at the bottom of the page it says, “[Ward round] Professor Walker-Smith” and it is a note signed by presumably a junior doctor, “colonoscopy” and then it gives, “prominent lymphoid follicles …” and “? some minor inflammatory changes” and then it says, “not to have MRI or L.P.” In other words, not to have an MRI scan and not to have a lumbar puncture. Then, Wednesday to have a barium meal. Were you aware at all of that note, Mrs 12? Were you aware at the time that that instruction had been given?
A No.

Emphasis added. But a colonoscopy and lumbar puncture were performed:

Q You say that you recall your son having a lumbar puncture and an MR scan; were you there for those?
A Yes.

Q You have obviously given consent for the MR but were you actually there when they were carried out?
A Yes.

Q Both of them?
A Yes.

Again, Mrs. 12 felt this was a research project:

Q You have told us that you thought that your son was part of a research investigation. Did you have any understanding as to which of those investigations, all of them or any of them, were part of the research investigations?
A As far as I understood, it was all part of the research into this possible link between the problems that [Child 12] had and the vaccine.

The tests apparently showed some immune activation

“Dear [Mr and Mrs 12],

I am writing to confirm the results from [Child 12]’s visit in the New Year. All were normal, including test for Fragile X, except the immune test. This shows evidence of persistent viral infection; i.e. [Child 12]’s immune system is activated in such a way that indicates it is trying to deal with some sort of ongoing viral infection. If you need to discuss these further please contact Dr Wakefield. I have passed on your query about gluten free diets to Dr Wakefield. I hope that [Child 12] is well and that his aching knees are settling”.

Then she gives some results at the bottom of the page. It shows,

“Full blood count and inflammatory markers – normal (i.e. no evidence of anaemia or inflammation”,

and various other negative tests.

Emphasis added. But above we read that the reason why Child 12 was referred for a colonoscopy was because a blood test indicated possible inflammation.

In June 1997, after the work at the Royal Free was finished, the attorney, Richard Barr, wrote to Mrs. 12:

“Thank you for your letters of 3 and 10 May 1997. I am sorry about the delay in coming back to you. I inevitably seem to be behind with my correspondence.

I haven’t heard anything more from the Vaccine damage Tribunal”.

Then he says,

“I haven’t had a copy of the Meridian TV item”,

so obviously you had made some reference to it, because he says,

“I would be very interested to see a copy if you can organise it some time.

We are all waiting for Andy Wakefield to deliver the goods and I really think that if he can provide the proof he thinks he can it is going to be much easier to win the cases.

I am interested in your comments about the rise in the incidence of mumps. What you say, of course, is absolutely correct.

I don’t think you have been updated on our fact sheet recently and in case it is of interest I enclose a further updated version. You will see that once again the section on autism has been extended. Don’t be deceived by the fact that it may not look quite as long as before. We have reduced the print size”.

Emphasis added.

After an extensive examination by the GMC’s attorneys, the defense was given an opportunity to cross exam:

THE CHAIRMAN: Mrs 12, as I indicated earlier, this is now the opportunity for representative counsel of the three doctors to cross-question you if they feel it appropriate. Are you happy to continue?
A Yes, that is fine.

THE CHAIRMAN: At any stage if you think that you need a little break, just give me a little hint and I am sure that the Panel will be quite sympathetic. Mr Coonan.

MR COONAN: Sir, I have no questions, thank you.

Mr. Coonan would be Mr. Wakefield’s attorney. He declined the opportunity to examine the one parent from the Lancet 12 who appeared at the GMC.

Mrs 12 was cross examined by Mr. Miller, attorney for Professor Walker-Smith.

Even as a summary this is long. But at least now people can easily check quotes in context.

← Older Entries
Newer Entries →