Archive | March, 2012

What letter, Mr. Olmsted? Why this one, of course.

14 Mar

When Brian Deer wrote one of his 2009 article for the Sunday Times: Focus: Hidden records show MMR truth, he introduced the article with a discussion of the father of Child 11, the only American child in the Lancet 12:

ON a Monday morning in February 1997, a taxi left the Royal Free hospital, in Hampstead , northwest London. It turned out of the car park and headed to the renowned Institute of Cancer Research, six miles southwest in Fulham.

In the back of the cab sat a California businessman, whose commercial interests lay in electroplating, but whose personal crusade was autism. On his lap was a plastic pot, in which snips of human tissue floated in protective formalin.

The snips were biopsies taken from the gut of the man’s five-year-old son, then a patient on the hospital’s Malcolm ward. The boy, Child Eleven, as he is known to protect his privacy, had been enrolled in a programme to investigate alleged risks of the three-in-one measles, mumps and rubella (MMR) vaccine.

Mr. 11, as he is known, was the one parent who chose to confirm the results he was given by Mr. Wakefield’s team at the Royal Free. In particular, he wanted to confirm whether the tissue samples taken from his son really contained measles virus, as he was told. After taking samples to people outside Mr. Wakefield’s team at the Royal Free:

“It took a big fight to get the information,” said Mr Eleven. “They told me there was no measles virus. I had the tests repeated three times at different labs in the US, and they all came back negative.”

This comes as no surprise to readers today. Mr. Wakefield’s graduate student, Nicholas Chadwick, was telling him all along that the virology results were negative.

In a later report, How the case against the MMR vaccine was fixed, Mr. Deer also introduced the article with Mr. 11. He noted that Child 11 was listed in the Lancet article as having a first behavioral symptom of “Recurrent “viral pneumonia” for 8 weeks following MMR” as occurring 1 week after the administration of the MMR vaccine, a point critical to Mr. Wakefield’s claims. However, according to documents available to Mr. Wakefield, the child showed signs before the MMR. Per Mr. Deer:

But child 11’s case must have proved a disappointment. Records show his behavioural symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13-18 months he developed slow speech patterns and repetitive hand movements. Over this period his parents remarked on his slow gradual deterioration.”

Enter Dan Olmsted, proprietor of the Age of Autism blog. Mr. Olmsted sought out Child 11’s father to corroborate Mr. Deer’s story. Such is the importance of contradicting Mr. Deer that he was willing to contradict Mr. Wakefield’s claim in the Lancet as well. Mr. Olmsted claims that Mr. 11 wrote him that rather than 13 months, “The onset of his autistic-like behaviors began around 18 months.”

The one thing that Dan Olmsted, Brian Deer and Mr. 11 apparently agree upon: the report in The Lancet is incorrect. Somehow I expect there is some convoluted explanation Mr. Olmsted would offer to avoid this problem, but lets move on. Unfortunately to a rather odd back-and-forth where neither party (Deer and Olmsted) communicating directly. To start, Mr. Olmsted would have us believe that Mr. 11 is annoyed? angry? with Mr. Deer’s reporting and thinks they “misrepresented the facts”.

Mr. Olmsted wrote:
[edit to add: Mr. Olmsted is quoting Andrew Wakefield’s defamation complaint here. I.e. these are Andrew Wakefield’s words]

Indeed, the child’s father has since written Deer and the BMJ to explain that Deer was misrepresenting facts about child 11, yet Deer and BMJ have printed no retraction, correction, or mention of this fact.

Mr. Deer noted this claim by Mr. Olmsted in his declaration:

Neither I nor (to my knowledge) the BMJ have received any letter from this father accusing me of “misrepresenting facts.” Nor have we received any request from this father asking for any retraction, correction, or for us to take any action at all. On the contrary, the father confirms the terms of the medical record (which he gave me at a meeting in California in September 2007), but disagrees with the accuracy of that record. The matter is thus purely a (very common) situation where parental recall and medical records do not coincide, and naturally parents believe their recollection to be right.

In a recent article, Mr. Olmsted wrote:

But the father told me: “Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration,” a clear contradiction that called for a prompt correction.

See what Mr. Olmsted did there? He cut short Mr. 11’s sentence and added his own ending. Which made me wonder, what was the full sentence and what was the full context.

If you are wondering that too, here is the full sentence from that email, in context:

Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication.

Is that an accusation of “misrepresenting facts” by Mr. Deer, as Mr. Olmsted asserts? Rather than call for a retraction or correction, as Mr. Olmsted claimed, Mr. 11 noted that “The Lancet article is a clear misrepresentation of my son’s history”, and that “the Lancet article is simply an outright fabrication.”

How do I know what is in the full email? Brian Deer entered it (redacted, of course) into the public record as an exhibit to his declaration. Given the way Mr. Olmsted was clearly cherry picking the email, I wanted to obtain the source for myself.

With apologies in advance for any transcription errors. But mostly with apologies to the young man who was Child 11 and to his father:

Daniel Olmstead
Brian Deer
Dear Mr. Olrnstead & Mr. Deer:
I have spoken with both of you regarding my son who may be one of the subjects in the Royal Free Hospital’s “research study” on autism summarized in the 1998 Lancet article.

The main reason I am contacting you now is to reiterate to Mr. Olmstead that we wish for our family to stay out of the public eye, and request that in any further discussions of this matter our privacy and the confidentiality of our son’s medical history be respected. We appreciate that in published work you, Mr. Deer, did that. My son has not consented to any disclosures regarding his medical history, and I hope that whatever information you disseminate will be shared in a manner that is not personally identifiable.

My second purpose in contacting both of you is to clear up some confusion, albeit generating additional questions which, as I explain below, I do not think are worth pursuing. Mr. Olmstead informed me that he believes that my son is Patient 1 I in the Lancet article, a conclusion he seems to have reached due to a violation of doctor patient confidentiality by Dr F. Given Dr. F’s distance, so far as I know, from these events, and his current state, it is hard to know what to make of this purported information. Mr. Deer’s article appears to assume that my son is Patient 11 as well, describing conversations with a father of “Patient 11 ” that appears to be me. However, we have no confirmation that Patient 11 is my son. When we got information during the Royal Free’s investigation, we were told he was Patient 13. Only 12 patients are reported in the Lancet article. I have no way of knowing how many subjects were excluded from the final report, or whether my son was one of them.

In any event, the description of Patient 11 in the Lancet article is not accurate if, in fact, it refers to my son. The Lancet article indicates that autistic symptoms started at 15 months, a week after the MMR, which is completely inaccurate; my son’s autistic behaviors started 2-1/2 to 3 months after the MMR, which was administered to him at 15 months. The Lancet article is a clear misrepresentation of my son’s history. Moreover, the Lancet article is not consistent with the Royal Free’s discharge summary regarding my son, and both the article and the discharge summary are inaccurate. One of the incorrect statements in my son’s discharge report was that autistic symptoms were seen from 13-18 months, while the vaccination was at 15 months. This is clearly inaccurate as his symptoms began several months after the MMR, as reflected in my initial correspondence to the Royal Free requesting my son be included in the research study. Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s
article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication. My son’s autistic behaviors did NOT begin a week after administration of the vaccine, in fact they began several months afterwards, with several medical complications occurring in between.

The bottom line is that, if my son is indeed Patient 11, then the Lancet article made a false assertion that his symptoms set in immediately after the MMR; in service of some attorneys’ efforts to prove “causation” that, unbeknownst to me, apparently drove this research. If the sloppy mishandling of patient information and inaccuracies in my own son’s records is any indication of how that research was done, then I am very thankful that the Lancet article has been withdrawn and the “research study” discredited. That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases. I have been involved in and have supported serious research into the causes of and effective treatments for this illness. We know now that the study reported in the Lancet article was a huge and very costly distraction. I hope that you will join me in looking, with an open mind, at real explanations of the current situation, as well as in advocating for adequate medical care and educational services for the many people affected, so that outcomes can be positive, as they are now proving for my son. While some autism may be a natural part of the human condition, what is happening now requires explanation. We will not get it if we spend time rehashing old debates.

As for the confidentiality issues, I appreciate and rely on your courtesy and discretion

Mr. 11 asked for courtesy and discretion on confidentiality issues. I would put to Mr. Olmsted that when he published the first name of Child 11, he may not have been heeding Mr. 11’s wishes.

The father has made a few more statements about these events:

First, about the Age of Autism series: “Olmsted’s logic is twisted and emotional”.

About the research at the Royal Free: “We all make daily human errors, but I guess some people ( Royal Free ) do it for a lifetime !”

and

“What a HUGE embarrassment, and scientific fiasco ! “.

Mr. 11 asked “That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases”

Whether one agrees with the “epidemic” or not, the idea of moving on from the “debacle” (which I read in context to refer to the story about Mr. Wakefield and the Lancet study) and focusing on research is a very wise suggestion. As Mr. Olmsted has shown, not only has Mr. Wakefield been a huge distraction, but his supporters have been as well.

A few details from Brian Deer’s declaration

13 Mar

Brian Deer’s declaration in the anti-SLAPP motion presents an interesting narrative of the history of the investigation into Andrew Wakefield’s MMR project. Of course much of it is not new for those who have followed the story, There’s the initial investigation for the Sunday Times. There’s the interaction with Richard Horton at The Lancet. There’s the slow unveiling of the “trickle truth” from Andrew Wakefield as he is faced with fact after inconvenient fact uncovered about his actions. There is Mr. Deer stating firmly and clearly that he is not in the pay of pharma interests. But there are also some points I don’t recall being made public.

Brian Deer got pulled in to the MMR story by the attention being drawn to a 2003 TV movie in the UK: “Hear the Silence“. This was a docu-drama about Andrew Wakefield. Sort of a small point in itself, but Mr. Deer also shared this detail:

For example, I interviewed John Walker-Smith, former professor of paediatric gastroenterology at the Royal Free, and the senior clinical author of the Lancet paper. Among other things, he told me that the TV docu-drama had been paid for by an American family involved in the research.

I don’t recall ever hearing or reading that “Hear the Silence” was financially backed by a family involved in the research.

As an aside, in reading up on “hear the silence” I found this news article which included this letter from a co-author of the 1998 Lancet paper:

Wakefield was not treated as a pariah by the hospital and the medical school. Indeed, it is interesting that the research team received lots of offers from distinguished researchers, who were willing to assist in the further development of the project along solid scientific lines. Although many members of the team welcomed those approaches, Dr Wakefield did not. Indeed he became increasingly insistent on meeting only those who were clearly ‘of the faith’. By so doing he made himself a pariah, since no self-respecting scientist would want to dispense with scientific rigour and objectivity.

That was in 2003. Just as Brian Deer was starting on the MMR project.

Back to Mr. Deer’s declaration. Another point I found interesting involves Mr. Wakefield’s credentials. Inflated credentials have been found all too often amongst those who promote the idea that vaccines cause autism. Consider Mr. Wakefield, now, as an example. In the past, Andrew Wakefield used his credentials: Dr Andrew Wakefield, MB, BS, FRCS, FRCPath.

MB, BS is for his degree: Bachelor of Medicine, Bachelor of Surgery.

FCRS stands for “Fellow of the Royal College of Surgeons”

FRCPath stands for “Fellow of the Royal College of Pathologists“.

When Mr. Wakefield filed his defamation case against the BMJ, Brian Deer and Fiona Godlee, he had already dropped the FRCPath. According to Mr. Deer’s declaration, Mr. Wakefield had been “expelled from the Royal College of Pathologists” in 2010.

This begs the question why the Royal College of Surgeons did not expel Mr Wakefield. Mr. Deer clarifies that: “the college has informed me that he was not in fact affiliated with the Royal College of Surgeons at any time in the last 15 years. Therefore, he
could not be expelled.”

Yes, Mr. Wakefield has apparently been using FRCS after his name without having the right to do so for 15 years. This includes in the documents he filed in the Texas courts for the defamation case.

What can one say: the top of page one of his petition includes an affiliation Mr. Wakefield apparently has no right to use. Perhaps a small point which will come as part of the many unwelcome surprises for his attorney.

Another odd fact was that Mr. Wakefield used a publicist as far back as 2003, when Mr. Deer first approached him. By Mr. Deer’s account, Mr. Wakefield is the only doctor he’s encountered with a publicist. Mr. Deer asked numerous times for interviews, but Mr. Wakefield has always declined. In one case, Mr. Wakefield allowed the Sunday Times to interview him, but only if Mr. Deer, the man doing the story, was not present.

Perhaps Mr. Deer has stated this somewhere, but he was attending the GMC hearings as a representative of Channel 4 (where he had done a documentary on Mr. Wakefield years earlier).

It is interesting to see just how many times Andrew Wakefield has sued or threatened suit against journalists.

Here is a quote from Mr. Wakefield’s business plan. This was drafted before the Lancet article was published and only obtained via a freedom of information act request. (Note that before the FOIA was enacted in the UK Mr. Wakefield’s hospital stonewalled attempts to obtain such documents). This isn’t really new information (it came out in the GMC hearing), but does have impact on the defamation claim:

It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA. It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.

It is very hard to argue that claims that Mr. Wakefield had clear financial conflicts of interest in light of such documents. Or that he had interests above and beyond his part as a paid expert in keeping the MMR litigation going. Or that these conflicts were hidden from the public, as they only came to light through FOIA long after the Lancet paper was published.

Here is an example of the defamation Mr. Wakefield alleges stems from comments by Fiona Godlee:

For example, in an additional allegation of fraud against Dr. Wakefield, Dr. Godlee referred, in her lecture, to a comparison of the interval between MMR vaccine exposure and “symptoms” in children reported by Dr. Wakefield and his colleagues in two different versions of the Lancet Article, a draft prepared in August 1997 and the final published paper, the Lancet Paper. Dr. Godlee went on to use this allegation as her basis to conclude that Dr. Wakefield fraudulently manipulated the reduction of the time interval in order to create “a legally compelling case which would be a maximum of 14 days and in this case an average of 6.3 days.” She not only falsely suggested that Dr. Wakefield fraudulently misreported this medical data, but she imputed to him a malignant intent that he knowingly altered this data in an effort to influence vaccine injury litigation. Both allegations are false and defamatory.

A key finding of the Lancet article was that 8 of 12 families blamed the MMR as the “apparent precipitating event” in causing their child’s autism. The time between MMR and onset of symptoms was 14 days. However, Mr. Deer has pointed out that more than the 8 reported families blamed the MMR. When those children were removed from the pool, the average time from MMR to onset of autism symptoms narrowed considerably (a point Mr. Deer has made repeatedly). What I hadn’t absorbed before was that Mr. Wakefield had admitted at one point that some of the parents’ recollections were omitted from his claim. From Mr. Wakefield’s press complaints commission submission:

Parents of 8 of the 12 children made the link between MMR vaccination and onset of symptoms contemporaneously. Other parents made the link retrospectively, that is, some years later. We reported on those 8 who made the link at the time of their child’s deterioration and excluded those who made the link later in order to remove any bias associated with recall that may have been prompted by, for example, media coverage.

If true, this would have been an important point to have made in the paper–or anytime in the 10 years after it’s publication. Not in a PCC complaint. That said, Mr. Deer points out where even Mr. Wakefield’s late admission is apparently false:

But this story cannot be reconciled with the children’s records as a whole. There were numerous notes of parents making the association later, whose testimonies he not only included in the paper, but adopted them as fact in his temporal calculations. For example, in the case of child 1, the GP writing to the Royal Free more than two years after the boy was vaccinated, described the parents’ association with MMR as their “most recent concern” as to the possible cause of his autism.

While on the subject of the PCC. What happened to Mr. Wakefield’s complaint? Turns out the PCC put it on hold until after the GMC hearings concluded. Mr. Wakefield never re-activated the complaint. He does refer to it (here’s an example from early 2011). Mr. Deer makes the case that the PCC complaint is an example of Mr. Wakefield using the complaints process (lawsuits, PCC, etc.) as debate tools. A point which if made would go to the argument that the defamation suit was filed frivolously.

As a related point– Mr. Wakefield *did* initiate an appeal of the GMC decision. He dropped it.

There is the (somewhat obvious, but I didn’t connect the dots as to the importance for the defamation case) fact that many of the details put forth in Mr. Wakefield’s “Secrets” series with the BMJ were first put forth in the lay press as MMR Doctor Fixed Data on Autism and Focus: Hidden records show MMR truth. Why is this important? Because Mr. Wakefield had 1 year from the data of first publication of statements to claim defamation, and these newspaper articles are from 2009, three years before the defamation claim. One wonders if this fact was made clear to Mr. Wakefield’s attorney in advance of filing the claim.

The following is more an observation of my own that something from the Brian Deer declaration. But, since Mr. Deer makes passing note of the recent “Health Freedom Expo” in Long Beach, California, I was reminded of this. Mr. Wakefield, together with a number of other members of the “vaccine epidemic” community. One thing I noticed when their talks were announced was the fact that speakers paid to give their talks. Under “register to speak” on the Health Freedom Expo website is listed “speaker fees”: $250 per 45-minute time slot. What I didn’t see before was this statement: You MUST be an Expo exhibitor to be a speaker. How much does it cost to be an exhibitor? Well, for the upcoming expo in Chicago, a standard booth costs $995. Did Mr. Wakefield (and his colleagues who spoke) pay $1245, plus travel expenses to attend? Plus the cost for a ballroom to host a fundraiser?

All these are tiny oddities in a long saga filled with much greater stories.

BMJ, Brian Deer file anti-SLAPP motion against Andrew Wakefield

11 Mar

About 2 months ago Andrew Wakefield filed a defamation lawsuit against the British Medical Journal, Brian Deer and Fiona Godlee for the series of three articles “The Secrets of the MMR Scare” and public comments made since. In particular, Mr. Wakefield took issue with statements about his research being fraudulent (and variations on that term like “fraudster”, “bullshit” etc.). Mr. Wakefield claimed that the facts presented by the BMJ articles were incorrect and based on information not available to him at the time he wrote his Lancet article.

Mr. Wakefield chose to file his defamation suit in Texas (his home state). This presented him immediately with two hurdles. First he has to show that the court has jurisdiction over primarily UK entities. Second he faced the possibility of an anti-SLAPP motion. SLAPP stands for “Strategic lawsuit against public participation“. Per Wikipedia:

A strategic lawsuit against public participation (SLAPP) is a lawsuit that is intended to censor, intimidate, and silence critics by burdening them with the cost of a legal defense until they abandon their criticism or opposition.

The typical SLAPP plaintiff does not normally expect to win the lawsuit. The plaintiff’s goals are accomplished if the defendant succumbs to fear, intimidation, mounting legal costs or simple exhaustion and abandons the criticism. A SLAPP may also intimidate others from participating in the debate. A SLAPP is often preceded by a legal threat. The difficulty, of course, is that plaintiffs do not present themselves to the Court admitting that their intent is to censor, intimidate or silence their critics. Hence, the difficulty in drafting SLAPP legislation, and in applying it, is to craft an approach which affords an early termination to invalid abusive suits, without denying a legitimate day in court to valid good faith claims.

Many states in the U.S. have enacted anti-SLAPP legislation. Texas enacted a law fairly recently and this motion could be the first major test of that law. I say “could” because of the first hurdle: jurisdiction. As Popehat has already noted, the plaintiffs in the anti-SLAPP motion “specially appear”. I.e. they keep the right to fight on jurisdictional grounds.

The motion and Mr. Deer’s supporting declaration can be found on Mr. Deer’s website. Mr. Deer’s declaration goes through the full history of his involvement with Mr. Wakefield’s research.

As Popehat notes, the motion appears quite strong. As is the case with legal motions, it covers multiple arguments. For example, they not only argue that the statements on their own are permissible speech, but they argue that the statements themselves are accurate.

Here is a section of the table-of-contents for the motion:

V. TEXAS’S NEW ANTI-SLAPP STATUTE APPLIES TO DR. WAKEFIELD’S CLAIMS.

VI. DR. WAKEFIELD’S CLAIMS FAIL BECAUSE HE CANNOT SHOW THAT THE CHALLENGED STATEMENTS ARE FALSE

A. Dr. Wakefield Must Prove that Defendants’ Statements Are Not Substantially True.
B. Dr. Wakefield Is Precluded from Re-litigating the GMC’s Findings, Which Establish the Substantial Truth of the Challenged Statements.
C. The Undisputed Evidence Also Establishes the Substantial Truth of the Challenged Statements.

1. Dr. Wakefield’s Misreporting and Falsification Permeated His Research.

2. Dr. Wakefield’s Undisclosed Conflicts of Interest.
3. Dr. Wakefield’s Review of the GP Records

VII DEFENDANTS’ STATEMENTS OF OPINION AND RHETORICAL HYPERBOLE ARE NOT ACTIONABLE.
A. Several of Defendants’ Statements, Including that Dr. Wakefield’s Research Must Have Been “Fraud,” Are Nonactionable Expressions of Opinion.
B. Defendants’ Expressions of Rhetorical Hyperbole and Colorful Language Are Not Actionable.

VIII DR. WAKEFIELD’S CLAIMS BASED ON BRIAN DEER’S WEBSITE PUBLICATIONS ARE BARRED BY THE STATUTE OF LIMITATIONS.
DR. WAKEFIELD IS A PUBLIC FIGURE, AND HE CANNOT SHOW ACTUAL MALICE.
A. Dr. Wakefield Is a Public Figure.
1. The “MMR Scare” Is a Public Controversy.
2. Dr. Wakefield Had More than a Trivial or Tangential Role in the
Scare.
3. Dr. Wakefield’s Claims Are Germane to His Participation in the
Controversy.
B. Defendants Did Not Act with Actual Malice.

1. Actual Malice Is an Exceedingly Difficult Standard to Satisfy.
2. The Evidence Here Precludes a Finding of Actual Malice.

Mr. Wakefield faces a number of burdens to overcome this motion. He must show that the statements made were more damaging that the truth. He must show that the statements are false–not just minor wording differences but that the “gist” of the truth is missing from the statements made. He must show that either he is not a public figure (very difficult for a doctor who has had a publicist for at least 10 years and has certainly put himself into the public sphere). He must show that Brian Deer, Fiona Godlee and the BMJ acted with actual malice.

He must present substantive evidence for each of these before he can go to trial. If he fails, he faces not only payment of reasonable legal fees and costs, but also the possibility of a penalty to deter future frivolous lawsuits. In that regard, the motion puts forth the history of Mr. Wakefield’s previous legal threats and lawsuits.

The most famous instance of Mr. Wakefield’s litigious history is his lawsuit against Brian Deer in 2004. Justice Eady made very clear statements on that:

[Dr. Wakefield] wished to use the existence of libel proceedings for public relations purposes, and to deter critics, while at the same time isolating himself from the ‘downside’ of such litigation, in having to answer a substantial defence of justification.

To put this in perspective–such a statement by the judge in Texas would almost certainly be followed by not only a dismissal of the case, but a financial judgement in favor of Mr. Deer, Ms. Godlee and the BMJ.

The motion makes it clear that Mr. Wakefield has faced negative commentary on his work and his character from many quarters in the past few years. From their introduction:

Two months ago, Dr. Andrew Wakefield was named by Time magazine as one of the “Great Science Frauds” of modern history. Last April, the New York Times described him as “one of the most reviled doctors of his generation.” In 2009, a Special Master presiding over vaccine litigation in the United States Court of Federal Claims recognized that Wakefield’s 1998 paper in The Lancet medical journal, which suggested a possible link between the lifesaving Measles, Mumps, and Rubella (“MMR”) vaccine and the development of autism in children, was considered a “scientific fraud.”

The Lancet has now fully retracted Wakefield’s paper, and its editor has state publicly that the paper was “utterly false” and that Wakefield “deceived the journal.” Wakefield’s home country’s medical board, the United Kingdom’s General Medical Council (“GMC”), convicted him in 2010 of multiple charges of “serious professional misconduct,” including “dishonesty” and “unethical conduct.” It further held that his misconduct had been so severe and extensive that the only punishment that would adequately protect the public from him was the permanent revocation of his medical license. As the New York Daily News put it, “Hippocrates would puke.”

As to specific instances of calling Mr. Wakefield’s work fraudulent, they quote multiple instances of the term being used. As noted above, one of the Special Masters in the Omnibus Autism Proceeding (vaccine court) called the work “scientific fraud”. Probably the most damaging instance for Mr. Wakefield are quotes from his own attorney in the General Medical Council (GMC) hearings who stated that some of the charges, if found proved, would amount to charges of fraud. Those charges were found proved.

There is definitely a movement amongst Mr. Wakefield’s supporters to recast his defamation suit as a retrial of not only his Fitness to Practice hearing before the GMC, but as a legal test of the validity of his MMR/autism hypothesis. Even just within the past couple of days Jenny McCarthy re-emerged in her role as a vocal Wakefield supporter with this (and other) erroneous arguments.

Courts are well aware of attempts for people to use defamation cases as a proxy for fighting other arguments. For example, readers might recall a recent defamation case where Barbara Loe Fisher (of the self-named National Vaccine Information Center) sued Dr. Paul Offit, writer Amy Wallace and Conde Nast publications for two words in an article: “she lies”. In the decision dismissing the defamation suit the judge noted:

Not only does Plaintiff’s claim of the statement’s falsity invite an open ended inquiry into Plaintiff’s veracity, it also threatens to ensnare the Court in the thorny and extremely contentious debate over the perceived risks of certain vaccines….and, at the bottom, which side has the truth on its side. This is hardly the sort of issue which would be subject to verification based on a core of “objective evidence”

and

Courts have a justifiable reticence about venturing into a thicket of scientific debate, especially in the defamation context

However, one must note that Mr. Wakefield’s defamation suit does *not* involve the issues of his research conclusions/findings (or non-findings as they have been retracted from the public sphere). The question put forth by Mr. Wakefield was whether statements such as “fraud”, “fraudster”, “determined cheat” are actionable defamation and whether these are based on allegedly misrepresented details from the research–such as diagnoses of the children and when symptoms appeared. Mr. Deer shows in his declaration that the facts presented in the BMJ studies are accurate.

On the “weight of evidence” front, consider this: Mr. Wakefield submitted a 17 page defamation claim. The defendants have responded with a 53 page anti-SLAPP motion and 5 declarations. The declarations include one from Mr. Deer with 101 pages and 104 exhibits. Where Mr. Wakefield is using a neighbor as his attorney, one who is not a specialist in health, media or defamation cases, the BMJ team are using a top Texas law firm and a total of seven attorneys. The lead attorney is listed as having experience with healthcare and publishers:

Tom has a wide range of experience in state and federal appeals and trials. His experience includes commercial, intellectual property, and healthcare litigation, and class actions. He has represented publishers and broadcasters in all aspects of media litigation throughout his career.

the second attorney listed has direct experience on defamation:

Marc’s practice focuses on media and privacy law, class actions, and general commercial litigation. His media law experience includes representing publishers in litigation involving claims for defamation, invasion of privacy, misappropriation, copyright, and related causes of action. In addition, he has defended companies in consumer class actions across the country relating to advertising and digital privacy. He regularly provides advice regarding website terms of service, arbitration agreements, and privacy law.

According to the BMJ’s motion, ” To avoid dismissal, the plaintiff [Mr. Wakefield] must submit “clear and specific evidence” to support each essential element of his claims.”

I suspect that Mr. Wakefield will have a meeting with his attorney very soon to discuss strategy. They are outclassed on the facts of the case, on the manpower and expertise of the attorneys and the credibility of the witnesses. They will discuss “each essential element of his claims” and how they stack up against the evidence presented. One might suspect that Mr. Wakefield’s attorney was unaware of how shaky their position was at the start, getting his facts from Mr. Wakefield. They now know, through hundreds of pages of arguments and evidence, how the defense can answer the “essential claims”.

If they can dismiss before the jurisdiction question is addressed and avoid the anti-SLAPP motion, they might be well advised to do so. The “reasonable costs” the BMJ are incurring are sure to be sizable. And the litigious history of Mr. Wakefield will surely play into a determination of whether to impose penalties on top of those.

From where I sit, Mr. Wakefield just doesn’t have the facts on his side. Nor does he have the law on his side. The jurisdiction question may be a blessing in disguise for Mr. Wakefield: giving him the opportunity to bow out before the anti-SLAPP motion goes into effect.

Sunnyvale police: Mother killed 22-year-old autistic son, then herself

8 Mar

The San Jose Mercury News reports today Sunnyvale police: Mother killed 22-year-old autistic son, then herself

A Sunnyvale woman who told neighbors she was “so tired” and could no longer handle caring for her 22-year-old autistic son shot him in his bedroom and then turned the gun on herself.

Elizabeth Hodgins’ husband came home at 7:45 p.m. Tuesday to find his wife and their son, George, dead, according to the Sunnyvale Department of Public Safety. Police declined to point to a motive. She left no note.

The story details how the mother wanted to get her son into a more community-oriented program. For the record, I am well aware of the program he was in before and it is excellent, with caring, dedicated staff.

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’.

Autism recurrence in half siblings: strong support for genetic mechanisms of transmission in ASD

5 Mar

Autism recurrence in half siblings: strong support for genetic mechanisms of transmission in ASD comes out of Dan Geschwind’s group at UCLA. They used the Interactive Autism Network database. Here is the abstract:

Current estimates of the heritability of autism spectrum disorders (ASD) derived from existing clinical twin studies1, 2, 3, 4 are potentially confounded by a number of factors, including low sample size, inconsistency in case definition and the role of de novo mutation (currently estimated to contribute to some 20% of cases), and the possibility that heritable causes of ASD in a twin could result in environmentally engendered affectation of a non-identical co-twin in utero, especially if mediated by humoral or immune mechanisms. To minimize these confounds, we compared autism recurrence in half siblings versus that in full siblings, using data (6 June 2011) from over five thousand families enrolled in the Interactive Autism Network (IAN), a national volunteer register for ASD, detailed characteristics of which have been previously described by our group. Recurrence rate among full siblings was observed to be approximately twice that among half siblings, providing strong evidence of genetic transmission of ASD.

The recurrence risk is the chance that a sibling has autism if another sibling does. The authors found the recurrence risk to be twice as high for full siblings, which is consistent with a primarily genetic model of autism risk.

This follows on a number of recent twin studies (here, here and here) have shown a lower concordance than previously estimated and the baby siblings study which showed a 19% recurrence risk for autism.

I wonder at how many half-siblings there are in the cohort. A small subpopulation could mean large error bars.

Roberto Marty, San Francisco School Bus Driver, To Stand Trial For Molesting Multiple Special Needs Students

5 Mar

This from the Huffington Post: Roberto Marty, San Francisco School Bus Driver, To Stand Trial For Molesting Multiple Special Needs Students. Obviously this is not yet proved. The story, however, tells of the possibility of more than one instance of abuse:

Long-time San Francisco Unified School District bus driver Roberto Marty stands accused of two counts of felony molestation–the first stemming from an incident occurring nearly a decade ago with the second allegedly happening last year.

Marty was investigated for inappropriate contact with a student in 2004; however, the San Francisco Police Department’s investigation found the claim to be without merit and Marty was allowed to continue driving buses for the district, a job he held since 1994.

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