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Mother Jones: Rep. Dan Burton’s Legacy: Lots of Sick Kids

1 Feb

Dan Burton, representative to the U.S. House of Representatives from Indiana announced today he would not seek re-election this year. Mother Jones has an article to mark the end of Dan Burton’s career in congress: Rep. Dan Burton’s Legacy: Lots of Sick Kids. The link says a lot “rep-dan-burton-goodbye-and-good-riddance”.

Stephanie Mencimer of Mother Jones starts out:

So Rep. Dan Burton (R-Ind.) is finally retiring, after two decades in Congress. He’s got a notable record of craziness, having doggedly pursued President Bill Clinton during the Monica Lewinsky scandal while knowing full well he’d had an affair himself and even fathered a child out of wedlock. He famously claimed to have shot up a “head-like object” (likely a melon or a pumpkin) to try to re-create the alleged “murder” of former Clinton deputy White House counsel Vince Foster, who committed suicide. But Burton doesn’t get enough credit for what may be his lasting legacy: helping turn Americans away from life-saving childhood vaccines.

Representative Burton has an autistic grandchild. Mr. Burton is of the belief that vaccines were causal in that autism. If you’ve read David Kirby’s book, “Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical” you know that Rep. Burton is a major figure in that narrative.

Rep Burton helped promote Andrew Wakefield’s ideas, including a hearing held in 2000. Mr. Wakefield’s testimony is not exactly what I would call accurate. As is now well known, Mr. Wakefield was financially supported by attorneys seeking to prove a link between the MMR vaccine and autism. When Rep. Burton asked him about financial support, here’s how Mr. Wakefield responded:

Mr. Burton. Who funded your study, Dr. Wakefield?
Dr. Wakefield. We did. We have a small charitable
contribution, but—-
Mr. Burton. A charitable organization did; I see.
Dr. Wakefield. We found it a little difficult to get
funding—-

Mr. Burton cut Mr. Wakefield off at this point, addressing another speaker at the hearing. “A charitable contribution” is a rather odd way to describe money from attorneys. Mr. Burton held at least six hearings on vaccines. That is not a problem. However, the evidence was going from weak to strongly against him over the years.

Mr. Burton has thankfully been more quiet on the issue in his recent years in office. Still, I’m with Mother Jones on this. Good Bye and Good Riddance.

Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

31 Jan

The U.S. Institutes of Medicine (IOM) will hold a meeting to discuss the feasibility of studying health outcomes in vaccinated and unvaccinated children. Health Outcomes Related to the Recommended Childhood Immunization Schedule will be held on February 9.

Activity Description

The IOM will conduct an independent assessment surrounding the feasibility of studying health outcomes in children who were vaccinated according to the CDC recommended schedule and those who were not (e.g. children who were unvaccinated or vaccinated with an alternate schedule). The IOM will review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule. Further, the IOM will identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them. A report will be issued in mid-2012 summarizing the IOM’s findings and conclusions.

Here is the draft agenda:

Draft Agenda
11:00-12:00 OPEN SESSION

11:00-11:15 Welcome and Overview
Ada Sue Hinshaw, Ph.D., R.N.
Committee Chair

11:15-11:35 Presentation of the Charge from the National Vaccine Program Office
Bruce Gellin, M.D., M.P.H.
Deputy Assistant Secretary for Health
Director, National Vaccine Program Office, US Department of
Health and Human Services

11:35-12:00 Review of IOM’s Committee to Review Adverse Effects of Vaccines
Ellen Wright Clayton, J.D., M.D.
Chair of the IOM Committee to Review Adverse Effects of
Vaccines
Craig-Weaver Professor of Pediatrics, Vanderbilt University

12:00-1:00 CLOSED SESSION –WORKING LUNCH

1:00-5:00 OPEN SESSION

1:00-1:20 National Vaccine Information Center Perspectives
Barbara Loe Fisher
Co-Founder & President, National Vaccine Information Center

1:20-1:40 Provider Perspectives
Gary Freed, M.D., M.P.H.
Professor, Department of Health Management and Policy,
University of Michigan School of Public Health
Director, Division of General Pediatrics
The Percy and Mary Murphy Professor of Pediatrics and Child
Health Delivery

1:40-2:00 The Use of Clinical Trials for Childhood Vaccines
Susan Ellenberg, Ph.D.
Professor of Biostatistics and Associate Dean for Clinical
Research
Perelman School of Medicine at the University of Pennsylvania

2:00-2:20 Ethical Issues in Clinical Trials
Robert (Skip) Nelson, M.D., Ph.D.
Senior Pediatric Ethicist/Lead Medical Officer, Food and Drug
Administration

2:20-2:40 BREAK

2:40-3:05 National Center for Immunization and Respiratory Diseases (NCIRD)
Centers for Disease Control and Prevention (CDC)
Melinda Wharton M.D., M.P.H.
Deputy Director, NCIRD, CDC
Captain, US Public Health Services

3:05-3:25 Immunization Safety Office (ISO) CDC
Frank DeStefano, M.D., M.P.H.
Director, ISO, CDC

3:25-3:45 Data and Approaches in National and International Immunization Studies
Saad Omer, Ph.D., M.P.H., M.B.B.S
Assistant Professor, Hubert Department of Global Health
Epidemiology, Emory University Rollins School of Public Health
Assistant Professor, Emory Vaccine Center

3:45-4:05 Immune Profiling Research
Chuck Hackett, Ph.D.
Deputy Director, Division of Allergy, Immunology, and
Transplantation
National Institute of Allergy and Infectious Disease

4:05-5:00 OPEN SESSION* — Opportunity for Attendee Comments

5:00 ADJOURN

Does MMR vaccine travel in time?

27 Jan

The news that the diagnosis of autism may be brought forward is primarily of importance because it may help identify children who will require specialised support. However, it is also interesting because it breaks the co-incidental temporal association that has been part of the reason the MMR vaccine-autism hypothesis gained traction. Since the behavioural cues for autism can’t be picked up well until after one year of age, parental concern about their child being different and autism diagnoses rose after administration of the MMR vaccine. This had unfortunate consequences for the perception of MMR vaccine’s safety.

Elsabbagh et al examined “brainwaves” (event-related potentials – ERPS) of babies with a familial risk of autism when presented with pictures of faces either gazing at the baby or away from the baby. Those children who went on to develop autism diagnoses had differing ERPs.

Although the evidence of fraud, failure to find epidemiological evidence to back-up Wakefield’s claims, and failure to find measles RNA that would have supported Wakefield’s work were enough to bury any scientific case for the MMR Vaccine-autism hypothesis, the fact that autism may now be diagnosed before the MMR vaccine lays a nice wreath on top.

Not all parents whose children developed autism blamed MMR vaccine, some parents were already aware of a “difference” about their child before MMR vaccine, but it is understandable how some parents would have made the connection with the vaccine. After all, it is a key part of how clinicians make connections between a drug and adverse event, and is a strong element of assessing causality (see Bradford-Hill criteria).

The causation in the MMR vaccine debacle was neatly illustrated in an article from Prescriber [Registration required] written by Paula McDonald (a former Consultant in Communicable Disease Control).

Some of these syllogisms may be plausible to some patients

Aristotle’s concept of syllogisms, says if certain prepositions are met, something distinct will arise from necessity. However, he also noted false syllogisms (In the UK we have an entire publication devoted to generating them, called the Daily Mail). McDonald’s figure illustrates the usual example of the horse being classified as a cat, along with the example of teddy bears and MMR vaccine causing autism.

You could replace the teddy bears with Peppa the Pig, or some other Greenfieldian scare. However, it sounds more convincing with vaccines, afterall you are introducing foreign material into a healthy child (and vaccines do cause adverse events sometimes).

Convincing people a false syllogism is wrong is a lot harder, than pointing out that A could not have caused B, because B arose months before A happened. Temporal associations are how we make sense of the everyday world. We don’t blame tripping up on a kerb on the beer we were going to have in the pub later that night.

Barring a Skynet conspiracy to send Terminators with MMR vaccine back in time to cause autism, this looks like a useful point to make to parents concerned about the risk of autism with MMR vaccine. Quite what the anti-vaccination groups will do, like the UK JABS cult, is interesting. Perhaps they will move to attack other vaccines given earlier, such as meningitis C or diptheria? Alternatively, they may look to the misapplication of physics, perhaps taking comfort in the news that neutrinos may have travelled faster than light, as their comrades-in-arms the homeopaths did.

Cross posted at Black Triangle.

The Omnibus Autism Proceeding: effectively over

21 Jan

The Omnibus Autism Proceeding (OAP) was held in the U.S. Court of Federal Claims to group the large number of claims filed involving autism and vaccines. The Docket was opened on July 3, 2002, nearly 10 years ago. The last entry was placed 1 year ago. Since then many cases have been dismissed. About half the cases are left to hear, but the fact that the two causation theories presented (that the MMR vaccine causes autism and that Thimerosal causes autism) were both found to have no merit (“not even close” one special master put it) and no new theory is proposed by the Petitioners’ Steering Committee (the attorneys who presented the case for the petitioners) makes it clear that the group claim, the omnibus, is effectively over.

That is not to say that other claims are not proceeding through the court, or that new cases will not be presented. There is at least one case pursuing the idea of mitochondrial dysfunction and autism, as with the Hannah Poling case. ([edit to add–the case ongoing, which was briefly closed, is not the Hannah Poling case. See the comments below). The case was actually dismissed for lack of action by the petitioners but the special master allowed it to continue again).

Looking back, the Omnibus peaked in 2003 when 2,437 cases were filed (close to 1/2 of the total that would eventually be filed).

Comment on “Timing of Increased Autistic Disorder Cumulative Incidence”

19 Jan

In 2010 a paper was published called “Timing of increased autistic disorder cumulative incidence.” The paper has made very little, if any, impact on the scientific community. But it has become part of the stable of poor quality papers used by those claiming that vaccines caused an autism epidemic.

The paper took data from other published papers and applied a “hockey-stick” analysis to try to identify change points in the administrative prevalence of autism in California, Japan and Denmark. Here’s the main figure from that paper (click to enlarge)

Figure-1-from-Timing-paper

The idea of a hockey-stick analysis is to fit the data to two lines of different slopes which meet at a change point. Those two lines look like a hockey stick, hence the name. For multiple reasons, I believe this analysis was not appropriate for these data.

The paper is being discussed in the literature. Once by Helen Ratajczak in her review paper Theoretical aspects of autism: Causes – A review. Another citation comes from a published response to that review: Coincidental associations do not provide proof for the etiology of autism. Also “Hypothesis: Conjugate vaccines may predispose children to autism spectrum disorders“.

Two additional papers citing the Timing paper include “Mast cell activation and autism” (funded by the National Autism Association, an organization which promotes the vaccine-autism epidemic idea) and “Oxytocin and autism: a hypothesis to research. Can perinatal oxitocinergic manipulation facilitate autism?” (in Spanish).

In my view, much like Ms. Ratajczak’s review, the major impact of “Timing of Increased Autistic Disorder Cumulative Incidence” has not been in the scientific literature. An internet search quickly shows that both papers have been quite well received by those promoting vaccines as a cause of autism, both within part of the autism/parent community and from the anti-abortion community. The “Timing” paper was immediately promoted by David Kirby in an article at the Huffington Post (Mr. Kirby was a major promoter of the idea that mercury caused an autism epidemic). The paper has since been picked up by many, including Andrew Wakefield who attempts to give his interpretation of a “hockey stick” analysis in his talks (click to enlarge):

Wakefield-Jamaica

The “Timing” paper is, quite frankly, weak at best. Weak enough that I am unsure why the authors’ superiors at the EPA chose to approve it even with the disclaimer, “Approval does not signify that the contents reflect the views of the Agency” (a disclaimer which Mr. Kirby ignored as he made comments like “according to the EPA” in his piece). With much better analyses of the California Data by Peter Bearman’s group at Columbia and Irva Hertz-Picciotto‘s group at U.C. Davis, the time for such simple analyses as in the MacDonald and Paul paper is past. Especially in a highly charged area such as autism.

If I had room given the word count restrictions on a reply I would have included some of these points. Instead in “Comment on Timing of Increased Autistic Disorder Cumulative Incidence” I focused on three points. First, the source that MacDonald and Paul used for their California data has a very clear and explicit disclaimer about the fact that those data are not high enough quality for scientific research. Second, the data are exponential. One can fit a “hockey-stick” to exponential data but the results are meaningless. There is no change point in an exponential curve. Third, plotting the data shows that there are change points, but at 1960 and 1974, not 1988 as MacDonald and Paul claimed from fitting one of the exponential regions of data.

In their original paper, MacDonald and Paul point out: “All data were taken from the publications with no attempt to access the original data.” This, as I pointed out in my comment, was unfortunate because the CDDS makes their data available to the public. This would allow one to double check hypotheses, such as whether a “hockey-stick” analysis is appropriate. For many reasons, it is an inappropriate analysis.

First, the California Department of Developmental Services (CDDS) make it clear that these data are not to be used to draw scientific conclusions. From the report where the EPA authors gathered their data:

The information presented in this report is purely descriptive in nature and standing alone, should not be used to draw scientifically valid conclusions about the incidence or prevalence of ASD in California. The numbers of persons with ASD described in this report reflect point-in-time counts and do not constitute formal epidemiological measures of incidence or prevalence. The information contained in this report is limited by factors such as case finding, accuracy of diagnosis and the recording, on an individual basis, of a large array of information contained in the records of persons comprising California’s Developmental Services System. Finally, it is important to note that entry into the California Developmental Services System is voluntary. This may further alter the data presented herein relative to the actual population of persons with autism in California.

If one ignores this major point (as the EPA authors did), there are still other reasons why their analysis method is inappropriate. One big reason is that trying to look for a single “change point” year in California isn’t supported by the data. The fact that autism rates vary dramatically by geography within California (as shown by both Prof. Hertz-Picciotto’s group and Prof Bearman’s group) points away from any universal exposure (such as vaccines). The data I have from the CDDS which breaks down the counts by region only go back to the early 1990’s, so with this and space considerations I did not included these data. These geographic data make it clear that not only do the autism rates vary by region, the time trends of those rates vary a great deal from one region to another. In other words, what is a change point for one region may not be one for another. Applying a single change point to all of California is not warranted using these data.

Another reason why the hockey-stick analysis is inappropriate is the fact that it forces a functional form to the data which is plainly a bad fit. A hockey-stick analysis fits the time trend to two lines with a “change point” where the lines intersect. Unfortunately, the data are exponential. The result is quite remarkable, really, given the geographic variability and the changing social influences on autism rates.

If one takes one of the CDDS datasets (I used one from 2007) and combines it with census type data, one can produce this figure (Figure 1 from the published comment):

Comment-figure

Graphing the data on a log-normal graph such as this shows that the data are exponential. Going all the way back to birth year 1930. It isn’t a simple exponential, though. There is a region around 1960 to 1974 where the growth stalled. It is remarkable that the same time constant fits the data all the way back to 1930, with the exception of this 1960-1974 region.

Fitting exponential data to two lines just doesn’t make sense. There is no “change point” in an exponential. One can force a fit onto exponential data, but it isn’t meaningful.

Using the log-normal plot I supplied one can see that there are change points in the trend. Obvious to any observer. But they are in 1960 and 1974, not in about 1987/88 as MacDonald and Paul calculated.

As is customary, MacDonald and Paul supplied a reply to my comment. In this they make only a very brief reference to the fact that the very document from which they pulled the California data states it is inappropriate to use it the way they did: “We agree with Carey (3) that analysis of long term epidemiological studies would be desirable and that there are a number of potential confounding issues associated with analysis of administrative databases.”

One mistake I made was in not clearly spelling out that fitting a hockey-stick to exponential data is inappropriate. It is obvious, but rather than address this problem MacDonald and Paul state:

Changepoints were determined by fitting a hockey-stick model (10) to the data for each dataset. This approach uses ordered data and piecewise linear regression to split the response variable into two groups. A linear regression line is generated for each group, and the point of intersection for these regression lines and the residual sum of squares for each line are determined. The intersection point that minimizes the residual sum of squares is the changepoint.

Carey (3) used a log transformation of the cumulative incidence to produce a log-linear relationship for the CDDS data of the form: Log (Cumulative Incidence) = B0 + B1 (Year). Subsequently, he states that he could not observe changes in the log-linear relationship of CDDS cumulative incidence at or around our changepoint year of 1989, but no other analysis was performed. Examining original CDDS data in the inset of Carey’s (3) Figure 1, it certainly seems likely that there is a changepoint in the 1985-1990 range, and being unable to observe such a change in the log-linear plot may be purely an artifact of the scaling of the plot. We conducted a changepoint analysis on transformed CDDS data from 1970 to 1997 (from (7)) and found a changepoint in 1984. The shift to an earlier changepoint using the log transformed data may result from stabilization of the variance associated with the transformation, and the resulting shift in the minimization point for the residual sum of squares for the regression line for the larger cumulative incidence values in later years.

It’s an odd response. The authors are focused on defending their original result of a change point in the 1980’s rather than considering the entire new dataset. They ignore the problems inherent in claiming a change point in exponential data, but I should have stressed that more in my comment. Even if MacDonald and Paul claim it is appropriate to make this fit, they ignore the obvious change points in the log-normal graph. Consider the change point at about 1960. It is abundantly clear in the log-normal graph. In the inset of my figure, the linear graph, that change point is still obvious to the eye.

If the real goal of their work was to identify change points there is no reason to ignore those which were (a) outside of their original time span and (b) obvious in a different presentation of the data. This is not just flawed, it is irresponsible. They are ignoring their own stated goal:

As we point out in the paper, while artifacts associated with observed increases in various studies cannot be ruled out, from a precautionary standpoint, it seems prudent to assume that at least some portion of the observed increases in incidence is real and results from the interaction of environmental factors with genetically susceptible populations. Since exposure to environmental factors is potentially preventable, identification of relevant candidate factors should be a research priority.

Why, I would ask, are potential environmental candidates which might involve change points in 1960 and 1974 not important, but one in the late 1980’s is?

Time Magazine: Great Science Frauds

14 Jan

Add Time magazine to the list of those calling out Andrew Wakefield a fraud. Not just any fraud, a “great science fraud”:

Great Science Frauds

Autistic Advocacy Group Condemns Presidential Appointment of Anti-Vaccine Activist Peter Bell

12 Jan

Peter Bell of Autism Speaks has been appointed to the President’s Committee for People with Intellectual Disabilities. As I read about the appointment I felt that there would be some reaction. Perhaps even a strong reaction. And, as you will see, I was correct. The Autistic Self Advocacy Network (ASAN) has issued a press release condemning the appointment.

Here is the press release:

FOR IMMEDIATE RELEASE

PRESS CONTACT:
Melody Latimer
Autistic Self Advocacy Network
Phone: 202-630-7477
mlatimer@autisticadvocacy.org

AUTISTIC ADVOCACY GROUP CONDEMNS PRESIDENTIAL APPOINTMENT OF ANTI-VACCINE ACTIVIST PETER BELL

Recent appointee Peter Bell has a long history of supporting fringe, anti-vaccine positions widely discredited in the scientific community

Washington, DC – January 12, 2012 – The Autistic Self Advocacy Network, the nation’s leading advocacy group run by and for Autistic adults, today expressed concern and disappointment over President Obama’s announcement Tuesday of his intent to appoint anti-vaccine activist Peter H. Bell as a member of the President’s Committee for People with Intellectual Disabilities.

“Bell’s appointment shows such contrast to the forward motion the Obama administration has shown in the areas of autism and disability as a whole,” said Melody Latimer, ASAN Director of Community Engagement and an autistic parent of autistic children herself.

Bell, Executive Vice President of Programs at Autism Speaks, has a long history of supporting anti-vaccination related causes, dating back to his time as President and CEO of Cure Autism Now, which merged with Autism Speaks in 2007. Despite wide ranging scientific evidence to the contrary, Bell and others in the anti-vaccine movement have long maintained the existence of a link, a position viewed as irresponsible by many public health advocates.

“The link between Autism and vaccines has long been discredited, and so an appointment placing an anti-vaccine leader in a position to influence a greater audience and re-open the issue is disappointing and ill-advised. We respect and appreciate the Obama Administration’s commitment to autism issues, but hope they will vet their appointees more carefully going forward,” Latimer noted.

Autism Speaks, Bell’s employer, has a checkered and controversial history. In 2009, Autism Speaks lashed out at the Department of Health and Human Services for refusing to incorporate research objectives connecting autism to vaccines in the Inter-Agency Autism Coordinating Committee’s Strategic Plan for Autism Research. In response to Autism Speaks’ disconnect from mainstream science on this question, several senior executives resigned from the organization in protest.

Autism Speaks has also been viewed with substantial controversy by Autistic people themselves, in large part due to the organization’s failure to meaningfully include individuals with the disability on their board of directors or in more than token roles in their senior leadership. Other criticisms of the organization include the low percentage of funds Autism Speaks invests in services, abnormally high executive salaries and what many have interpreted as deeply offensive advertising utilizing fear and pity to raise money. In 2009, the organization debuted its much-ridiculed video “I Am Autism” at the United Nations in New York City, presenting autism as an anthropomorphic force aiming to steal children. After widespread protests from Autistic adults across the country and criticisms from other disability organizations, Autism Speaks eventually pulled the promotional film.

The Autistic Self Advocacy Network (ASAN) is the nation’s leading advocacy organization run entirely by and for Autistic adults and youth. ASAN’s supporters include Autistic adults and youth, cross-disability advocates, family members, professionals, educators and friends. ASAN was created to provide support and services to individuals on the autism spectrum while working to change public perception and combat misinformation by educating communities about persons on the autism spectrum. The organization’s activities include public policy advocacy, community engagement to encourage inclusion and respect for neurodiversity, quality of life oriented research and the development of Autistic cultural activities and other opportunities for Autistic people to engage with others on the spectrum.

Brian Deer responds to David Lewis’ complaint

10 Jan

Much attention has been focused on Andrew Wakefield again recently. This follows Mr. Wakefield’s lawsuit against Brian Deer, Fiona Godlee and the British Medical Journal (BMJ). Also, a lengthy complaint authored by David Lewis was made public, detailing his views about the allegations of fraud levied against Mr. Wakefield by the BMJ.

The two are not directly related as Mr. Lewis’ complaint fails to address many of the issues raised by the BMJ in their articles alleging fraud. That said, If one pokes around Mr. Deer’s website, one will eventually stumble upon this page: David L Lewis: indignant abuse as complaints turn to nothing. There is an introduction to the subject including Mr. Deer’s interactions with Mr. Lewis followed by a point by point response to Mr. Lewis’ complaint. For anyone who may be thinking that Mr. Deer is intimidated by the complaint I encourage you to read the response. It is very much in the style of Brian Deer. For example

DAVID L LEWIS: “My report, which I have submitted to UCL, UKRIO and HEFCE, includes 72 emails exchanged between me and the BMJ’s editors.”

DEER: I offer the recipients at UCL, UKRIO and HEFCE my sympathy.

Aside from such dismissive statements, Mr. Deer takes on the many (often repetitive) claims by Mr. Lewis directly. Mr. Lewis’ complaint and main thesis in his rapid response to the BMJ focus on non-specific colitis as used in the Lancet paper: the histology grading sheets of Dr. Dillhon somehow prove that there was no fraud. It is a confusing argument because it doesn’t address the many issues raised by Mr. Deer and the BMJ.

Per Mr. Deer in his introduction:

These biopsy assessments, however, weren’t the basis upon which, in January 2011, the BMJ concluded that Wakefield’s MMR work was “an elaborate fraud”. The evidence we presented rested firmly on the GMC panel’s findings of research dishonesty, and was overwhelmingly related to Wakefield’s activities with regard to the admission of patients to the study, as well as the purported clinical histories and findings which lay behind a claim by Wakefield of a 14-day temporal link between the administration of MMR and the first “behavioural symptoms” of autism. We say this purported link was fraudulent.

Later, in response to Mr. Lewis’ claim:

DAVID L LEWIS: “… alleged that Andrew Wakefield fabricated the diagnosis of colitis in a 1998 Lancet study involving 12 children with autistic spectrum disorder (ASD).”

Mr. Deer responds:

DEER: At the core of our problems in dealing with Lewis is that nowhere was such an allegation made in the BMJ. He repeatedly identifies my feature “Autistic enterocolitis under the microscope”, published in April 2010, but this simply doesn’t make such an allegation. Plain reading would make this clear.

Not only can I find no foundation for this fundamental of Lewis’s complaint (and I think I’d remember forming any view at that time that the histopathology reporting in the Lancet was fraudulent, as distinct from, say, wrong, misleading or incompetent), we consulted legal counsel, before and after publication, and expert peer-reviewers. We remain unable to identify any text inferring Wakefield’s intent with regard to histology reporting. I’ve similarly asked Nature to identify any such text, and they too have failed

Mr. Lewis has taken issue with the fact that the BMJ did not print his rapid response exactly as submitted:

DAVID L LEWIS: “To support their new fraud theory, Godlee rewrote my Rapid Response, removing any evidence that undermined their allegations against Wakefield and others.”

DEER: Lewis’s rapid response was extensively re-written because it was false and defamatory. Legal advice was taken. Two peer reviewers rejected the submitted text. No changes had any effect in supporting any “fraud theory”, whether new or otherwise. Lewis approved the published text.

In hosting the words of Mr. Lewis, the BMJ would itself be responsible in part for any defamatory language included. This is the way of the law in the U.K..

In my opinion, the Mr. Lewis’ arguments are a side show of the the Wakefield saga (Yes, in my view Mr. Wakefield is a major side show in itself). They don’t address the substance of the claims of fraud put forth by the BMJ.

The Autism Vaccine Controversy and the Need for Responsible Science Journalism

7 Jan

The Huffington Post has a new section on science. One of the first articles discusses the “Autism Vaccine Controversy”. In The Autism Vaccine Controversy and the Need for Responsible Science Journalism, Seth Mnookin starts out:

Earlier this week, The Panic Virus, my book on the controversy over vaccines and autism, was released in paperback. While there haven’t been many scientific advances in this particular issue since the hardcover edition was published — the evidence supporting vaccines’ paramount place in public health efforts and the total lack of corroboration supporting a causal connection between vaccines and autism remain as strong today as they were a year ago — there have been new developments in the story. Their coverage highlights an enduring passion of mine: The need for reliable, responsible science journalism.

Yes, Seth Mnookin, author of The Panic Virus, is writing for the Huffington Post, a site which has contributed greatly to misinformation about vaccines and autism. The Huffington Post has been home to David Kirby (who was a major promoter of the mercury/autism concept) as well as welcoming input from Jenny McCarthy and Jim Carrey, to name but a few of the poor choices for writers the Post engaged.

On PLoS blogs, Mr. Mnookin announced this new gig with Has the Huffington Post embraced science & closed the door on anti-vaccine quackery? We can hope. I wouldn’t place any bets on it though.

No Evidence of Murine Leukemia Virus-Related Viruses in Live Attenuated Human Vaccines

6 Jan

There has been much discussion of XMRV, Xenotropic murine leukemia virus-related virus, here at Left Brain/Right Brain and elsewhere in the past few months. The reason for the discussion here is the (now shown to be false) idea that XMRV is implicated in autism causation. Two papers have addressed this question and found no evidence of a link. XMRV came to prominence as a possible candidate in causing chronic fatigue syndrome (CFS). Multiple papers have found no evidence of a link between XMRV and CFS (fan example is discussed here) and the original paper on the topic was withdrawn by editors of the journal Science after it became clear that those results were suspect.

The idea that autism and XMRV was promoted by David Kirby, whose efforts also strongly promoted the debunked autism-epidemic-caused-by-mercury idea. Mr. Kirby’s article at the Huffington Post was Is Autism Associated with A Viral Infection?. In this he quoted CFS/XMRV researcher Judy Mikovits:

And then Dr. Mikovits dropped a bombshell that is sure to spark controversy.

“On that note, if I might speculate a little bit,” she said, “This might even explain why vaccines would lead to autism in some children, because these viruses live and divide and grow in lymphocytes — the immune response cells, the B and the T cells. So when you give a vaccine, you send your B and T cells in your immune system into overdrive. That’s its job. Well, if you are harboring one virus, and you replicate it a whole bunch, you’ve now broken the balance between the immune response and the virus. So you have had the underlying virus, and then amplified it with that vaccine, and then set off the disease, such that your immune system could no longer control other infections, and created an immune deficiency.”

Mr. Kirby went on to write:

So there you have it – a possible explanation of regressive autism in a significant number of cases associated with immune system deregulation triggered by vaccination.

Of course, much more work is needed to nail down the exact significance of such an association. For example, is the virus implicated in the cause of autism, or do children harbor the virus as a result of autism?

Yes, Ms. Mikovits and David Kirby were proposing a possible link between autism, XMRV and (of course) vaccines.

That was October 2009. Fast forward to today, two years later and we see

A) Neither Ms. Mikovits nor anyone else has published the data supposedly linking XMRV and autism

B) Two studies have looked for evidence (and failed to find any) of a link between XMRV and autism,

Lack of infection with XMRV or other MLV-related viruses in blood, post-mortem brains and paternal gametes of autistic individuals.

PCR and serology find no association between xenotropic murine leukemia virus-related virus (XMRV) and autism.

C) Evidence has arisen that much of the data linking XMRV to CFS is faulty.

Studies on XMRV are still ongoing. If experience from the vaccine-autism-epidemic idea tell us anything, the idea that XMRV causes CFS and/or autism will die slowly and even more data are needed.

To that end, a recent study explored whether XMRV is a contaminant in live virus vaccines. (note that in other vaccines, the XMRV is likely as dead as the other constituents of the vaccine). You can tell the result from the title: No Evidence of Murine Leukemia Virus-Related Viruses in Live Attenuated Human Vaccines.

Background

The association of xenotropic murine leukemia virus (MLV)-related virus (XMRV) in prostate cancer and chronic fatigue syndrome reported in previous studies remains controversial as these results have been questioned by recent data. Nonetheless, concerns have been raised regarding contamination of human vaccines as a possible source of introduction of XMRV and MLV into human populations. To address this possibility, we tested eight live attenuated human vaccines using generic PCR for XMRV and MLV sequences. Viral metagenomics using deep sequencing was also done to identify the possibility of other adventitious agents.

Results

All eight live attenuated vaccines, including Japanese encephalitis virus (JEV) (SA-14-14-2), varicella (Varivax), measles, mumps, and rubella (MMR-II), measles (Attenuvax), rubella (Meruvax-II), rotavirus (Rotateq and Rotarix), and yellow fever virus were negative for XMRV and highly related MLV sequences. However, residual hamster DNA, but not RNA, containing novel endogenous gammaretrovirus sequences was detected in the JEV vaccine using PCR. Metagenomics analysis did not detect any adventitious viral sequences of public health concern. Intracisternal A particle sequences closest to those present in Syrian hamsters and not mice were also detected in the JEV SA-14-14-2 vaccine. Combined, these results are consistent with the production of the JEV vaccine in Syrian hamster cells.

Conclusions

We found no evidence of XMRV and MLV in eight live attenuated human vaccines further supporting the safety of these vaccines. Our findings suggest that vaccines are an unlikely source of XMRV and MLV exposure in humans and are consistent with the mounting evidence on the absence of these viruses in humans.

Yes, there is no evidence of XMRV in vaccines. This is rather anticlimactic given the evidence already in place that XMRV is not linked to autism, and the fact that the XMRV/CFS link is already tenuous at best.

The blogger erv has done the most thorough job following the XMRV study out there, including discussing the paper above. Others have taken up where David Kirby left off and promoted the idea that XMRV and autism are linked, and that vaccines are a possible part of that link. I would hope that those people would see the value in letting their readers know about this paper (and others, and the retractions).

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