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Hannah Poling and the Pediatrics thimerosal study: two “big” stories with little press response

18 Sep

Two stories which are “big” news in some segments of the online autism community are the settlement amount for Hannah Poling and the recent study showing no link between autism and thimerosal in vaccines. While these have caused a fair amount of discussion on blogs (like this one), they didn’t generate that much press coverage.

We broke the Hannah Poling award story here on LeftBrainRightBrain on September 3. The story was ignored, even by such pro autism-as-vaccine-injury blogs as the Age of Autism until September 9th, when Sharyl Attkisson (who has some connection to the people at the Age of Autism blog) wrote about it for CBS.

There are a couple of dozen entries in Google News on Hannah Poling. Few major outlets. One that did carry it is the Atlanta Journal Constitution, the home town newspaper for the Poling family. In Settlement reached in autism-vaccine case the AJC quoted Dr. John Shoffner:

Dr. John Shoffner, a neurologist and national expert who has conducted research on autism and its causes, said researchers have found no link between vaccines and autism. And he said he strongly favors vaccination.

“The preponderance of data shows that vaccines are important and safe for children to prevent preventable and sometimes life-threatening infectious diseases,” Shoffner said. “I certainly am in favor and support the CDC’s as well as the American Academy of Pediatrics’ recommendation of vaccination.”

Shoffner is a co-author of a journal article that describes Poling’s case without naming her.

Edited to add: I forgot to include this quote from the Atlanta Journal Constitution:

“It’s critical to remember that the government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines,” said Martin Kramer, communications director for the Health Resources and Services Administration. The National Vaccine Injury Compensation Program is part of the administration. The U.S. Court of Federal Claims decides who will be paid damages for injuries that result from vaccines, under a 1988 law that created a program.

Another so-called “big” story from the last few weeks is the study on autism and thimerosal in Pediatrics, Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. Sometimes when an important paper comes out (that I am aware of) I watch Google News as the embargo is lifted. I did so with this paper. Nothing happened. OK, I think Disability Scoop had a story out right at midnight (this one, if I recall correctly). Heck, it wasn’t until Friday that the CDC added the study to their website (it isn’t mentioned on the main cdc.gov webpage). Even SafeMinds (who are, in cases like this SafeBet–as in, it is a safe bet they will put out a critique of the paper) didn’t respond for days.

Sure, I was interested. And, yes, these stories sparked some of the most active conversations on this blog in a while. But I am still left with the basic conclusion: the general public has already absorbed these stories. The government conceded the Hannah Poling case 2 years ago. It isn’t new. The idea that mercury in vaccines cause autism–no longer part of the front line public discussion.

I’m not the only one to make this comment. The Washington Post had this to say four days after the paper was made public:

But when the journal Pediatrics published on Monday a study that found no increased risk of autism among more than 1,000 babies who’d been exposed prenatally or in the first 20 months of life to ethylmercury from vaccines, it was met with a general shrug. Neither The Washington Post nor The New York Times even reported on it, though the Los Angeles Times did, in its Booster Shots blog.

Sure, these stories will never completely go away. The vaccine/autism story will never go completely away. But the heyday is over.

Sharyl Attkisson blogs the Hannah Poling settlement

10 Sep

I had forgotten Sharyl Attkisson. She is a reporter for CBS news who has covered vaccines in the past, but has been silent on the issue for the past year or more.

Her recent piece shows exactly the sort of reporting that frustrated me in the past: Family to Receive $1.5M in First-Ever Vaccine-Autism Court Award

In that piece she links to her piece from 2008 on the Hannah Poling case: Vaccine Case: An Exception Or A Precedent?

Here’s a quote from that earlier piece:

While the Poling case is the first of its kind to become public, a CBS News investigation uncovered at least nine other cases as far back as 1990, where records show the court ordered the government compensated families whose children developed autism or autistic-like symptoms in children including toddlers who had been called “very smart” and “impressed” doctors with their “intelligence and curiosity” … until their vaccinations.

They were children just like Hannah Poling.

What’s still being debated is whether the Poling case is an exception … or a precedent.

So, which is it? Were there children “just like Hannah Poling” or is this the “First-Ever Vaccine-Autism Court Award”?

Actually, it is neither. This isn’t the first vaccine court award involving autism, and the other cases are not “just like Hannah Poling”.

For real information on the other nine cases, read Kathleen Seidel’s piece on Neurodiversity.com. Few, professional or amateur, can compare the the thoroughness of Kathleen Seidel. For example, one case (the first I read involving autism from the vaccine court) is Suel v. HHS. Young David Suel had tuberous sclerosis, a condition known to be associated with autism and epilepsy. Epilepsy occurs in about 60 to 90% of individuals with TS. Autism occurs in about 25-50%. David Suel’s case was declared to be a “table injury” wherein the seizures began within a set period after his DPT vaccination. What is notable about that is the table for DPT was later changed–when it was shown that DPT was not responsible for inducing seizure disorders. In other words, had David Suel been vaccinated, or just filed, after the change in the table, he likely would not have been awarded damages.

“They were children just like Hannah Poling”? Is tuberous sclerosis just like mitochondrial disease? (answer: not even close).

Shall we go on? In her recent piece, Ms. Attkisson states:

In 2002, Hannah’s parents filed an autism claim in federal vaccine court. Five years later, the government settled the case before trial and had it sealed

Not accurate. The court did not “settle” the case in 2007. They conceded the case, and they were in the process of completing the settlement when someone leaked the information to the press. The government did not “seal” the case–it is standard procedure to keep this information confidential until the settlement is completed.

But that doesn’t make a good story, does it?

Ms. Attkisson goes on:

In acknowledging Hannah’s injuries, the government said vaccines aggravated an unknown mitochondrial disorder Hannah had which didn’t “cause” her autism, but “resulted” in it. It’s unknown how many other children have similar undiagnosed mitochondrial disorder. All other autism “test cases” have been defeated at trial. Approximately 4,800 are awaiting disposition in federal vaccine court.

Mito-autism was a big thing for a while there. David Kirby took the story and ran with it–making a lot of mistakes along the way and propagating a lot of misinformation. It is unknown how many other children have similar disorders–but the researchers who studied cases like Hannah Poling have stated that cases such as hers are “rare”.

“All other autism “test cases” have been defeated at trial”.

What is conspicuous about the other “test cases” is that in none of them was it argued that the children were like Hannah Poling–i.e. the attorneys did not argue that a mechanism of autism through mitochondrial dysfunction aggravated by vaccines existed. In fact, one child named as a test case was pulled from that slot in order to argue that mitochondrial based case. The expert report filed for that child (since pulled from the Omnibus website) did not argue mitochondrial disorder or dysfunction at that time. In other words, the idea of a mitochondrial disorder being linked to autism was so alien from the cases being made by the attorneys for the families in the Omnibus that this child had to argue the case separately.

It is often pointed out that many autistics may have mitochondrial dysfunction. This is based largely on studies out of Portugal. It is left implied, and it is often believed that mitochondrial dysfunction means vaccine injury in these cases. This was the impression that David Kirby put forth and it was clearly wrong. First, mitochondrial disorders are a very broad spectrum. The type that Hannah Poling has is not the same as those detected in most autistics. Second, most reports of mitochondrial disorders and autism, including the Portugal studies, do not involve regression. Third, even amongst those children reported by the groups that identified Hannah Poling, regression was often idiopathic or followed fever clearly independent of vaccination.

I do not expect Ms. Attkisson to present the following (quality) information, so I will repeat it here:

Here are the answers to some questions posted to mitochondrial medicine experts and their answers:

When asked, to respond to the position: ‘‘I view the risk of vaccination in known metabolic disease patients to generally be outweighed by the risk of the infectious diseases being vaccinated against”

63.2% strongly agreed
31.1% agreed
0.9% disagreed
and 0.9% strongly disagreed.

Asked about the opinion that the risk of vaccination in metabolic disease was ‘‘greater than the risk of the infectious diseases being vaccinated against”

52.9% strongly disagreed
40% disagreed
3.5% agreed
and none strongly agreed

A busy week in vaccine-injury news: the Cedillo appeal

4 Sep

The past week has had three somewhat major news events in the world of vaccine injury: the denial of the Cedillo appeal, the award of damages in the UK for an MMR case and the damages award in the Hannah Poling case. I thought I would write about them all, but the Cedillo appeal part is already long so I will leave the other subjects for another time.

The Cedillo Appeal

Kev blogged the denial as Cedillo appeal denied. I had blogged the hearing in June as Another appeal heard in the Autism Omnibus, then blogged the actual audio from the hearing as Audio of the Cedillo appeal part 1 and Audio of the Cedillo appeal part 2.

The arugument used in the Omnibus Autism Proceeding for MMR causing autism is basically the model that grew out of the work of Andrew Wakefield: that measles virus (MV) from vaccines persisted in the body, particularly in the digestive tract. Wakefield’s theory involved the MV infection causing intestinal permeability which allowed substances to “leak” out into the system (the “leaky gut” hypothesis). The Cedllio’s attorneys argued that the measles virus itself traveled to the brain, causing inflammation and autism.

This is not the first appeal for the Cedillo family, or for the test cases in the Omnibus. It is likely the last, however. The next step would be the U.S. Supreme Court. The Supreme Court would be unlikely to hear an appeal. The Supreme Court does not hear all the cases submitted, instead choosing to hear mostly cases which clarify points of law. The Cedillo appeal so far has not been about the laws for the most part but about the procedure of the case. One exception is the question of whether the correct standard was applied to reviewing the admissibility of the evidence. The Court used the Daubert standard, which the Cedillo’s attorneys argued was incorrect. This is not the first time the Court used Daubert, and it is not the first time the appeals court upheld it.

The other arguments made include whether the testimony and reports of Dr. Stephen Bustin should have been allowed. Dr. Bustin’s reports were obtained very shortly before the hearing and were based on closed documents from a U.K. proceeding on MMR and autism. The Cedillo’s attorneys argued that they were unable to prepare a counter argument to Dr. Bustin on short notice and that since they did not have access to the underlying data and documents. In a civil court, these arguments would have carried much weight. However, in the vaccine court, much flexibility is allowed. In this case, the Special Master allowed the evidence to be heard, and gave the Cedillo’s attorneys over a year to obtain the background data from the UK and mount a counter argument.

The Cedillo’s attorneys did not attempt to obtain the background data for the Bustin testimony in year that followed the hearing. Yes, it isn’t that they were unsuccessful, they didn’t try to obtain it. They stated that their consultants in the UK advised them that it was unlikely that they would be able to obtain the documents without the permission of the experts. However, Dr. Bustin gave his permission.

From the appeals court decision:

Petitioners considered making such a re-quest from the UK court, but never did so. They contend that British counsel informed them that it was unlikely that the UK court would permit disclosure of the expert reports without the consent of the experts, which peti-tioners stated that they could not obtain. But Dr. Bustin did consent to the release of his reports. Once his consent for the release of his reports had been obtained by the government, there is no reason why the data underlying his reports could not also have been requested

Dr. Bustin’s testimony focused on a critical part of the argument used to claim that MMR causes autism: the claimed presence of measles virus in the bodies of autistics like Miss Cedillo. Dr. Bustin is arguably the worlds top expert on PCR, the method used by the Unigenetics Laboratory to test tissue samples for measles virus. Dr. Bustin discussed at length multiple reasons why the Unigenetics Laboratory results were not reliable.

A few points to be made here.

(1) The Cedillo’s attorneys presented an expert (Dr. Kennedy) to claim that the Unigenetics laboratory was reliable. Dr. Kennedy also had worked on the UK litigation and Dr. Kennedy’s underlying data were also under seal in that litigation. In other words, the Cedillo’s attorney’s were asking that the Special Master apply one standard to the government’s witness (rejecting his report without the underlying data) while applying the exact opposite standard to their own witness (Dr. Kennedy, who also didn’t have the underlying data).

(2) Michelle Cedillo was one of three “test cases” used to test the question of “general causation”. The other two children used as test cases did not have evidence of persistent measles virus in their bodies.

There is only one paper with reliable data showing the presence of measles virus in the tissues of an autistic child. This paper came out after the Cedillo hearing. The paper: Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. In that study they found measles virus in one autistic child, and in one non-autistic “control”. The Cedillo’s attorney’s argued that this was “significant new evidence” that showed the reliability of the Unigenetics laboratory.

I found it very odd that a paper titled “Lack of association between Mealses Virus Vaccine and Autism with Enteropathy” would be used as evidence for an association between measles virus vaccine and autism. But the argument is that this paper validates the Unigenetics laboratory as being able to produce reliable results. The argument is not valid, and the court did not agree with it. The work done by Unigenetics on Miss Cedillo was performed in 2002. The research on the paper was performed much later, after significant criticism was already levied against Unigenetics. Quite simply put, it is possible that Unigenetics “cleaned up its act” by the time of the recent paper.

(3) It was noted that the arguments about Dr. Bustin’s testimony were essentially moot, as the Special Master would have come to the same decision without his testimony.

(4) It was also noted that the appeals court had already decided on Dr. Bustin’s testimony in an appeal mounted by the attorneys for the Hazelhurst family (another of the Omnibus test cases).

The Cedillo’s attorneys further argued that it was unfair that evidence was brought in from the other “test case” hearings (Hazelhurst and Snyder). The appeals ruling noted that the Cedillo hearing was not a stand-alone proceeding. As a test case in an Omnibus Proceeding, evidence from all the test cases would be used to answer the question of general causation. I was surprised at the time of the appeal that the Cedillo’s attorneys were arguing that they were not actively monitoring the other test case hearings. What, in the end, is the point of an Omnibus Proceeding or a “petitioners steering committee” of the petitioners are not acting in some way as a group?

The Cedillo’s attorneys argued that the Special Master did not give enough weight to Miss Cedillo’s doctor, Dr. Krigsman, who stated that her condition was caused by MMR. The fact is that the Special Master rejected Dr. Krigsman’s argument with good cause:

He [the special master] also concluded that Dr. Krigsman’s opinion should be rejected because 1) he relied on the discredited Unigenetics testing in forming his opinion, 2) he misunderstood Michelle’s medical history and his testimony was inconsistent with her medical records, and 3) his conclusion that Michelle suffered from chronic gastrointestinal inflammation was substantially out-weighed by Michelle’s medical records and the testimony of the government’s experts.

The Cedillo’s attorneys argued that sufficient weight was not given to Miss Cedillo’s other physicians whom, they assert, associated her condition with the MMR vaccine:

Petitioners cited nine notations in Michelle’s records from eight individuals, including four physicians who treated Michelle and four non-physicians who exam-ined Michelle, in which the treating physicians mentioned her vaccinations, as support for the proposition that these individuals concluded that her autism was caused by her MMR vaccine.

The appeals court disagreed:

The Special Master did not err in failing to afford sig-nificant weight to the opinions of Michelle’s treating physicians. As the Special Master observed in his deci-sion, in seven of the nine notations, the physician was simply indicating an awareness of a temporal, not causal, relationship between the fever Michelle experienced after her MMR vaccine and the emergence of her autistic symptoms sometime thereafter. Initial Decision, slip op. at 100. In one of the other notations, the physician sim-ply noted that an exemption for Michelle from vaccination requirements could be arranged. In the other notation, the physician speculated that Michelle’s fevers might have caused her neurological abnormalities. However, he expressly stated that it would be “difficult to say” whether this was “a post-immunization phenomenon, or a separate occurrence.” Id. at 100. Thus, “none of the treating physicians concluded that the MMR vaccine caused Michelle’s autism.” Final Decision, 89 Fed. Cl. at 176. The Special Master

In the end, the appeals court decision takes on the arguments by the Cedillo’s attorneys point by point and refutes them. The closest the Cedillo’s attorneys got to making a point stick was in the case of Dr. Bustin’s testimony, which the appeals court stated:

We agree with petitioners that the government’s fail-ure to produce or even to request the documentation underlying Dr. Bustin’s reports is troubling, but we think that in the circumstances of this case, that failure does not justify reversal.

The fact of the matter is, the petitioners in general, and the Cedillo’s in specific, did not have a good case for MMR causing autism. The mechanism they proposed was not sound, the data they had was poor and incomplete and the experts speaking for the government were excellent and refuted the petitioner’s arguments. The Omnibus cases were, as the Special Masters noted, not close.

Damages awarded in the Poling case?

3 Sep

A document has recently been posted the Court of Federal Claims website, describing an award in a vaccine injury case. The document is redacted, but the following paragraph indicates to me that this involves the case of Hannah Poling:

Respondent has conceded that petitioners are entitled to compensation due to the significant aggravation of Child’s pre-existing mitochondrial disorder based on an MMR vaccine Table presumptive injury of encephalopathy, which eventually manifested as a chronic encephalopathy with features of autism spectrum disorder and a complex partial seizure disorder as a sequela.

The amount involves 4 parts: (1) a payment of about US$1.5M for life care, future earnings and pain-and-suffering, (2) a lump sum payment of about US$140,000 for past unreimbursable expenses, (3) a lump sum payment of about $7,800 to cover a medicaid lien and (4) an undisclosed amount to purchase an annuity to cover items in the life care plan.

The award amount seems larger than typical to me. I don’t put this out as a criticism. Rather the opposite. If we as a people are going to compensate those injured by vaccines, as we should, we should compensate highly. We can not fully compensate a person or a family for injury. For example, the cap on pain and suffering damages has not been increased in the roughly 25 years that the vaccine program has been in place.

It is not easy to write this piece, and I hesitate to publish it. Assuming this document refers to the Poling family, they chose to redact information.

I will end with this statement from the Special Master who wrote the decision:

Based on the persuasive factors supporting petitioner’s vaccine claim and respondent’s election not to challenge petitioner’s claim, the undersigned finds that petitioner is entitled to compensation under the Vaccine Program. Accordingly, a determination of damages is appropriate.

MMR vaccine damaged man

30 Aug

Jackie Fletcher is well known to many – she routinely insists the MMR jab is dangerous despite reams of evidence to the contrary. However, a panel in the UK has found that her son, Robert, was damaged by the MMR vaccine he was administered.

I nearly didn’t blog about this. Why? Well, this blogs predominant focus is autism and Robert did not and does not have autism. The panel in this case found that the MMR caused seizures and mental retardation. Its difficult therefore to get a ‘hook’ into this story. As Mike Fitzpatrick is quoted as saying in the Daily Mail:

It is a very important principle that parents should be compensated in cases of this kind…

and he’s absolutely right. Thats why the Vaccine Damage Payment Unit exists in the UK.

Like any other form of medical procedure, vaccines are not 100% safe. I can’t recall anyone anywhere ever making that claim. What they _are_ however, is very safe indeed. Robert Fletcher was injured and has been compensated. I might even agree with his mum that the amount is ‘derisory’. Robert will need full time care all of his life and £90,000 ($140,000) is nowhere near enough. However, campaigners uninterested in Robert’s day to day needs say that:

Campaigner Polly Tommey, who edits the magazine The Autism File and believes her son Billy is autistic because of MMR, says: ‘This is fantastic news. Now doctors can’t tell me that the MMR is safe.

‘This payout is evidence that it is not safe. It’s interesting that they will look at epilepsy and not autism, and you have to ask why.

‘Is it because the compensation would be billions?’

I very much doubt that any doctor, anywhere has ever told any recipient anywhere that any vaccine is 100% safe. If they did, they were liars.

However, this payment, far from being ‘evidence that it is not safe’ (a bizarre claim) is more like a recognition that the Vaccine Damage Payment system is working as it should. A man was vaccine damaged and was compensated as a result.

As for the claim that ‘they’ will not look at autism, this is simply incorrect. Robert, does not have autism and therefore it would be impossible in this case to look at autism. I would imagine if someone with autism was adjudged to be damaged by their MMR vaccine, Ms Tommey might have a point. As that has not happened, she does not. This kind of fear-mongering by the likes of Tommey is no doubt why the panel made the clear point:

We would stress that this decision is fact-specific and it should not be seen as a precedent for any other case.

In particular, it has no relevance to the issue… as to whether there is a link between the MMR vaccine and autism.

And Fletcher goes on to claim:

Claims for autism are not considered. There are 120 MMR cases waiting to be heard, but none is for autism…

So why should that be? Why is autism apparently ‘excluded’?

Its because the science – both epidemiological and clinical clearly shows that MMR does not cause autism. And that is not the odd paper here and there. We are talking about overwhelming science that shows that the whole autism/MMR connection is simply false and was built up by one man too stupid to admit his clear errors and a mass media keen to build sensation out of this same man’s ego.

Tommey, Fletcher and all others who believe that there’s some kind of conspiracy afoot to block autism from MMR causation cases need to understand the science involved and that unless some new science is forthcoming that establishes MMR as a causative agent in regards to autism then the simple fact of applying for compensation listing the MMR as a cause of their child’s autism is _always_ going to be an immediate strikeout.

Campaigners need to start seeing this event for what it _really_ is – compensation for a vaccine damaged man – and not as what it isn’t – evidence that MMR is inherently unsafe or that theres some mysterious conspiracy to prevent autism from being linked to MMR.

Another example of the workings of the vaccine court

4 Aug

This doesn’t involve the autism cases. Instead it is about the Hepatitis B omnibus proceeding which is also ongoing. It does involve some familiar names: Clifford Shoemaker (attorney), Dr. Mark Geier and his son David Geier. It does give us some insight into the billing practices of these gentlemen.

As background I’ll note that Clifford Shoemaker subpoenaed blogger Kathleen Seidel of Neurodiversity.com. He ended up being sanctioned for that action.

Dr. Mark Geier has been a frequent consultant to Mr. Shoemaker’s cases in the vaccine court. Ms. Seidel has covered some of the cases before where Dr. Geier has participated.

David Geier has so far not been compensated as a consultant to the Court.

In a recent case, Quinton O. Riggins, Jr. v. Secretary of HHS, we can see some of the decision processes involved in awarding fees to attorneys and consultants in the Court.

The application was for a total of $221,211.34:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

Of this, about $96k was paid:

Accordingly, petitioner is entitled to the following award for fees and costs for efforts in the Riggins case and for efforts on the hepatitis B cases in general: $95,801.72 for attorney’s fees and costs to be paid by check payable to petitioner and petitioner’s counsel; and $528.25 in petitioner’s costs to be paid by check payable to petitioner. The Clerk shall enter judgment accordingly.

The analysis of the application is lengthy. I will quote some sections below.

In regards to Mark and David Geier:

“Petitioner’s counsel requests $110,386.73 in costs related to S&A’s general hepatitis B work, of which counsel has earmarked $97,443.43 as costs (for fees and expenses) owed to Dr. Mark Geier and his son, David Geier.”

In the end, Dr. Mark Geier was paid $10,000 and David Geier was not compensated.

In denying payment to David Geier, who holds a bachelors degree, the Special Master noted:

“In summary, the undersigned finds the costs for David Geier’s efforts to be obviously unreasonable as Mr. Geier is not qualified to address the medical issues involved in the Program and his work was duplicative of the efforts by Dr. Geier. Thus, the undersigned denies the request for costs for David Geier in its entirety.”

In regards to Dr. Mark Geier:

However, Dr. Geier’s qualifications as an expert, testimony in the Program, and credentials, have been subject of considerable criticism over the years by the court. The undersigned questioned his expertise as far back as 1991. Daly v.Sec’y of HHS, No. 90-590V, 1991 WL 154573, at *7 (Cl. Ct. Spec. Mstr. July 26, 1991) (“[T]his court is inclined to not allow Dr. Geier to testify before it on issues of Table injuries. Dr. Geier clearly lacks the expertise to evaluate the symptomatology of the Table injuries and render an opinion thereon.”). More recently, in a published Order, my colleague, Special Master Vowell, addressed this criticism, as well as her concerns regarding petitioners utilizing medical articles authored by Dr. Geier, as follows:

I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters and several other judges have opined unfavorably on his qualifications and testimony as an expert.

It appears that since the Court has found that Dr. Geier is not qualified as an “expert”, he was retained as a “consultant”. However, he appears to have acted in ways overstepping the bounds of “counsultant”.

In the instant matter, the undersigned finds it was reasonable (and appropriate) for counsel to consult with Dr. Geier in a limited manner regarding the hepatitis B claims. Those efforts would entail Dr. Geier performing an initial review of the counsel’s hepatitis B claims and some initial research regarding vaccine injuries resulting from hepatitis B vaccine. Dr. Geier would then educate counsel as to the nature of the issues and the types of experts required. However, once Dr. Geier performed an initial review of these claims for counsel, and once counsel began reaching out to doctors who would ultimately serve as experts in S&A’s hepatitis B claims, it was no longer reasonable for Dr. Geier to be billing hours and incurring costs in S&A’s general hepatitis B efforts. Dr. Geier at this point was moving well beyond the role of a consultant.14 Thus by the beginning of 2002, when Mr. Shoemaker began to meet with experts15 to assist in the prosecution of the hepatitis B claims, Dr. Geier’s work on behalf of S&A’s general hepatitis B efforts was no longer needed and should have concluded.

Because of this, Dr. Geier was compensated at a reasonable amount for his consulting activities.

The undersigned notes an award of $10,000.00 represents an almost 90% reduction of the invoice submitted by the Geiers in this matter. The award of $10,000.00 is reasonable for Dr. Geier’s consultant efforts, and thus should not be viewed as a “reduction,” but viewed as reasonable compensation for Dr. Geier’s role as a consultant. The time not compensated is time largely spent by Dr. Geier duplicating the efforts of the experts, duplicating his own work, or performing work as an expert (work he is not qualified to perform). Stated another way, once experts were identified and became involved, Dr. Geier’s role as a consultant ended.

Mr. Shoemaker requested $221,211.34 in fees and costs:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

The court found that $64,254.45 was reasonable.

Here is an example of a charge that was denied:

The 5/30/2006 entry bills 0.5 hours to “[r]eview excel chart and update information; transfer information needed for SC to laptop,” P. App at 18. The “transfer information needed for SC to laptop” entry was explained by counsel asconstituting mere seconds and thus not administrative overhead. P Resp at 2, fn 1. However, counsel failed to address the remainder of the entry and identify what excel chart he was updating and how that activity was relevant to Mr. Riggins’ case. However, far more egregiously, counsel has billed for this exact same activity on precisely the same date twice before in two separate hepatitis B cases.

Trips to France and Italy were also excluded:

Another extreme example of counsel’s error in billing judgment is the request by counsel for fees and costs billed by Dr. Mark Geier and David Geier for trips to France and Italy in the summer of 2005 and winter of 2006 respectively, and for Mr. Shoemaker to travel to France with the Geiers in the summer of 2005. These requests represent a complete abdication of billing judgment.

Dr. Geier and Mr. Geier together billed a total of over $20,000.00, P App at 62-63, to travel along with Mr. Shoemaker to France and meet with various doctors and lawyers to discuss adverse events following the hepatitis B vaccination. Dr. Geier, in his affidavit, and counsel in Petitioner’s Sur-Reply, allege it was necessary to travel to France to discuss the doctors’ and lawyers’ experiences and research relating to adverse reactions stemming from the hepatitis B vaccination, and that this information could only be obtained in “face-to-face” discussions. In addition, Dr. Geier and Mr. Geier together billed $23,690.00 to travel to Italy to attend the 5th International Conference of Autoimmunity. Petitioner argues in Petitioner’s Response that the Geiers were invited to present their research at the conference by Dr. Shoenfeld, a leading expert in autoimmunity, and that at the conference they were able to secure Dr. Shoenfeld’s services as an expert in counsel’s cases. Petitioner further alleges the Geiers were able to discuss autoimmune disorders with experts at the conference and further “expedite the prosecution of various hepatitis b cases.” P Resp at 12.

and

Additionally, the Geiers provided absolutely no supporting documentation, such as receipts, to evidence the $9,399.68, see P App at 60, they allege they incurred in costs for airline tickets, other transportation costs, parking, hotel, “daily expenses,” food, and conference fees during these trips. P App at 61-62. By itself, this failure justifies not awarding these costs.

Many expenses for Mr. Shoemaker were questioned by the Special Master. Some based on the lack of adequate justification for the costs:

Petitioner’s counsel has failed to provide adequate information for the undersigned to determined exactly what the costs represent and whether or not the costs were reasonably incurred. No receipts are provided for any of these expenses. For example, for what did counsel pay costs to Federal Express? Who traveled to Boston and stayed at the Ritz Carlton? What expert was met with in Boston? Who traveled to Florida? And what attorney was met with in Florida?

Other expenses were considered to be “overhead”

Respondent objects to five hours of time billed by counsel for “‘meeting with consultants about scanning issues’” on April 19, 2000; one hour of time billed by counsel for “‘review[ing] computer breakdowns and update computer field’” on October 8, 2002; and three hours of time billed by counsel for a “consultation with Legal Nurses Association to discuss reviewing cases and preparing chronologies” on September 19 and 21, 2001. R Opp at 17; see also R Reply at 7. Respondent objects to these billings on the basis that the billings are administrative in nature, “more properly categorized as overhead” and would benefit “all petitioners represented by [counsel’s] firm.” Id. The undersigned agrees.

The entire decision is 37 pages long, detailing the requests for reimbursments, fees and costs.

What constitutes a blogger “bully”?

10 Jul

There are events around the autism blog-o-sphere that are troubling as of late. Events which bring up the question of bullying in a very real way.

First some background:

Andrew Wakefield is on a book tour. He has spoken at a park in Chicago and to small groups in New York, Phoenix and London. Events surrounding these engagements have very strange, if you ask me. And it is getting stranger.

The Chicago event was, well, a bit of damp squib, to quote Kev. Not a big event, even though it was timed to coincide with a large autism parent convention. Many of the attendees were actually skeptics who showed up as a bit of a silent protest.

The event in London was originally billed as “Dr. Andrew Wakefield is at a secret location in London with a select group of ticket holders for a book signing and Q&A session.” At one point it was going to simultaneously shown as a pay-per-view on the internet (something like $70, if I recall correctly), but ended up being free. The event location was kept secret at first and is reported to have been moved with vague comments of “threats”.

Frankly, I take any possibility of threats seriously and I worried that this might be serious. While I disagree with much of what Mr. Wakefield has to say, I would strongly condemn any threats to his talks.

When I heard that there was controversy about Mr. Wakefield’s Phoenix appearance, I took it seriously and wanted details.

The Phoenix event was held at the Ritz-Carlton Hotel. Prior to the event, one skeptical blogger emailed the Ritz-Carlton. She states that she emailed the Ritz-Carlton twice. Below is her communication:

Andrew Wakefield June 26 at The Ritz in Phoenix

Dear Sir / Madam,

I’m writing to express my extreme disappointment that such a well thought of hotel as the Ritz is playing host to this event on Saturday.

Disappointingly, The Autism Society of Greater Phoenix has chosen your venue to promote unsupported quack therapies and to support Andrew Wakefield, a man whose scaremongering has led to disastrous falls in vaccination levels among children. Levels have fallen so far that measles – a potentially fatal or crippling disease, even in countries with good levels of health care such as the UK – is now reported as once again being endemic here. Vaccination is arguably the greatest medical invention or discovery of our age, and has without doubt saved more lives worldwide than any other medical procedure. Hosting a book signing by Mr Wakefield would only indicate support for his unethical methods (including taking blood from children at a birthday party, and carrying out colonoscopies on vunerable autistic children for non-medically indicated reasons)

Many anti-vaccine activists want to return us to an age of deaths from preventable illnesses, claiming, against all evidence that vaccines are harmful, simply in order to promote their own agenda.

Andrew Wakefield is not a brave, maverick doctor, fighting the establishment, as The Autism Society of Greater Phoenix would have it; rather he has recently been struck off the medical register for horrific breaches of ethics involving non-indicated clinical procedures on children and undisclosed conflicts of interest.

Should you allow this event to go ahead, I fear your company’s reputation will be seriously tarnished, and respectfully ask you to reconsider your decision.

Best regards,

Rebecca Fisher

Andrew Wakefield – GMC ruling: http://www.gmc-uk.org/Wakefield_SPM_and_SANCTION.pdf_32595267.pdf
Vaccine preventable diseases – American Academy Of Paediatrics: http://www.aap.org/pressroom/aappr-photos.htm

The AutismOne newsletter portrayed the blogger’s actions as:

Rebecca Fisher: Pharma Blowhard or Concerned Citizen?

You can’t be a parent in this community without bumping into them. Every article, TV program, blog or radio show brings them out in force. The mention of “autism” or “Dr. Wakefield” brings them scurrying out from under their rocks snapping and snarling and spitting about the wonders of vaccines and their self-anointed roles as concerned citizens in protecting the pubic health.

It’s a scam and we all know it. Most of the bloggers, poseurs, and self-ordained autism experts have ties either directly or indirectly to pharma or mainstream medicine (which is really one and the same thing). Age of Autism has done a remarkable job outing Orac and shedding light on the soft underbelly of the vaccine apologists.

Rebecca Fisher of the UK has been very busy lately. Blogging here under the title “JABS Loonies – Justice, Awareness, Basic Support and Mind Blowing Stupidity,” Rebecca recently left the Internet safety of anonymity to engage in more concrete acts of aggression against our community.

Rebecca’s current mission is attempting to frighten, bully or pressure venues Dr. Wakefield is scheduled to speak at on his current book tour into canceling the event. Hotels are under siege by email, fax, and phone demanding they cancel Dr. Wakefield’s appearance.

For a week before this past Saturday, Rebecca attempted to intimidate the Phoenix Ritz-Carlton site of Dr. Wakefield’s latest talk into capitulation. To their credit the Ritz told her, in essence, to take a hike.

Rebecca, who also blogs as Becky Fisseux, will continue to act in a dangerous and reckless fashion until she is outed and her connections to pharma publically revealed.

Still the attacks will continue until we take legal and other appropriate actions necessary to incur real costs on those who spread lies and misinformation.

Unfortunately, the Ritz-Carlton Phoenix will not comment on the event. Ms. Fisher make a reasonable list of alleged facts that are unsupported within the complaint raised in the AutismOne newsletter. She requests proof that:

[She has] sent any more than two emails to the Ritz Carlton Group

She has] have ever telephoned the Ritz Carlton Group

I have ever sent a fax to the Ritz Carlton Group

I contacted the Ritz Carlton Group on more than one day

I used language that could be construed as “bullying”, “intimidating” or “harrassing” in my two emails (actually just one email, sent to two addresses)

The Ritz Carlton told me to “take a hike” – or in fact contacted me in any way

The AutismOne newsletter references recent events involving the blogger Orac at Respectful Insolence. It doesn’t speak well of AutismOne that they believed the Age of Autism blog piece about Orac. That piece claimed that the surgeon behind Orac had undisclosed financial ties to a pharmaceutical company, leading to a campaign to get him fired from his job. Seriously, people were encouraged in the comments on AoA to contact his employer. It is a pretty low moment for the Age of Autism. (if you are curious, Steven Novella takes apart the claimed conflict in his piece Age of Autism Witch Hunt.)

It would be all too easy to claim that the threats (and real) intimidation level is rising. I don’t know if that is the case. In recent years a blogger was expelled from an AutismOne conference for asking a tough but pertinent question of Terri Poling (mother of Hannah Poling, whose case before the vaccine court was very important–and will be again once the final settlement is reached and announced.) AutismOne is reported to have ejected journalists as well.

It is worth noting that blogger Kathleen Seidel was subpoenaed by vaccine injury lawyer Clifford Shoemaker.

I take threats seriously, as I stated above. I take bullying seriously too. It is worth questioning whether this statement “Rebecca’s current mission is attempting to frighten, bully or pressure venues Dr. Wakefield is scheduled to speak at on his current book tour into canceling the event” is really upheld by the facts. Since the Ritz-Carlton will not comment, I will await some sort of substantiation that what Ms. Fisher has done constitutes “frightening” or “bullying” or “pressure”.

I’ll leave you with the final line from the AutismOne newsletter piece on this:

“Still the attacks will continue until we take legal and other appropriate actions necessary to incur real costs on those who spread lies and misinformation.”

UN Calls Shock Treatment at Judge Rotenberg Center ‘Torture’

1 Jul

The Judge Rotenberg Center (JRC) is a school for special needs children. The JRC is known for the fact that they use aversives–in the form of electric shocks–as part of their program. Not all students get the shocks, but it is a part of the program there.

The ABC program Nightline will air an episode on JRC tonight. Their website already has a story, UN Calls Shock Treatment at Mass. School ‘Torture’.

Here is a quote from that story:

“To be frank, I was shocked when I was reading the report,” said Manfred Nowak, the UN’s Special Rapporteur on Torture. “What I did, on the 11th of May, was to send an urgent appeal to the U.S. government asking them to investigate.”

The United States Department of Justice already opened an investigation on the JRC earlier this year after a consortium of disability organizations sent a complaint letter.

How to report adverse reactions to supplements

30 Jun

I have often complained that no one seems to be interested in collecting adverse event data from alternative medical treatments. For example, one child who was a test case in the Omnibus Autism Proceeding (the vaccine court) appears to have reacted very negatively to chelation. We only heard about this because the Omnibus proceeding. DAN and other organizations do not seem to be collecting or reporting on adverse events.

I have often read adverse reactions to alternative therapies in online forums. No one seems to consider reporting those.

In searching for information on supplements, I did find this FDA site for reporting adverse reactions.

There is an online form, MedWatch Online Voluntary Reporting Form (3500), which can be used to report adverse events.

I can not find a database comparable to VAERS which has the data from these reports compiled for view. Since I have never read of anyone reporting their bad reaction to an alternative medical treatment, I doubt whatever database the FDA is keeping is very complete.

Audio of the Cedillo appeal part 2

16 Jun

We’ve recently discussed the first part of the audio from the Cedillo appeal (the part where Miss Cedillo’s attorney was speaking) in Audio of the Cedillo appeal part 1. Here I share notes on the second half of the audio: where the government’s attorney is speaking.

I should have done this before, but a little nomenclature:
The U.S. Government is represented by the Secretary of Health and Human Services. She doesn’t actually take part, but is represented by attorneys from the Department of Justice (DoJ). The government is referred to as the “Respondent” in these proceedings.

The Cedillo family is represented by their attorney, Ms. Chin-Caplan. Michelle Cedillo is the “petitioner”. Her case is one of the “test cases” heard in the portion of the hearings to determine if MMR causes autism. Her case served two purposes. First, to argue that in her specific situation vaccines resulted in some or all of her conditions. This is referred to as “specific causation”. Second, her case presented evidence on the general question of whether the MMR (alone or with Thimerosal) could cause autism. This is referred to as “general causation”.

Ms. Chin-Caplan is working as both the attorney for Ms. Cedillo and as a member of the “Petitioner’s Steering Committee” or PSC, which is the association of attorneys working with the 5,000 plus families who filed petitions claiming autism as a vaccine injury. Those 5000 plus cases are grouped in the Omnibus Autism Proceeding, or for short: OAP, or “Omnibus”.

Again, my observations are added in italics.

The DoJ attorney didn’t even finish her introduction before one of the judges jumped in to ask about the fact that in a regular civil court, the underlying documents would have to be produced or Prof. Bustin’s testimony would be excluded. The fact remains that in the vaccine court, that rule (rule 26) does not apply. As noted in the first half of the audio, the PSC attorneys could have asked for those rules to apply but they did not do so.

The judge goes on to say that it was the government’s responsibility under the federal rules to obtain the documents to support the testimony.

I will add here that I am somewhat unclear if these are the Federal rules for the vaccine court, or the Federal rules (e.g. Rule 26) for the civil court. It sounds to me like they are the rules for the civil court.

The DoJ attorney noted that they tried to get everything from the UK litigation. All the expert reports and information. However, the solicitors they were working with in the UK suggested that their petition was too broad and would be denied. So, on advice of those solicitors, the DoJ narrowed the request down to only the three expert reports.

It sounds to me as though the DoJ attorneys were possibly unaware that the evidence–in this case the actual lab notebooks from the Unigenetics laboratory–were not going to be produced in full with the expert report. Even if so, I don’t see this really as an excuse.

However, some of the pages which Prof. Bustin used in his testimony were reproduced. These include pages that showed that Unigenetics made corrections after the dates on the notebooks.

Another observation: the laboratory notebooks are not all of the information from which Stephen Bustin made his report and it is not all the information which he used to form his testimony in the Cedillo case. Not all of his testimony would be excluded without the full laboratory books, in my opinion. Prof. Bustin spent considerable time investigating Unigenetics

The DoJ attorney noted that they went to the UK to obtain the information only after they learned that the Unigenetics laboratory results constituted a key part of the petitioner’s case–four months before the case was heard. They had to “hussle” to get the information unsealed. The judge asked if the DoJ had a responsibility to inform the petitioners of their intent to obtain this information. The DoJ stated that she did not believe that was the case.

The full witness list for the government was not finalized and made public until shortly before the proceeding. One list of potential witnesses was made available to the petitioners in March 2007–four months before the hearing–but that list is not public. The final list for both sides was made public on June 12, 2007. To me, this may indicate that the DoJ attorneys were *not* required to give more lead time on their witnesses or strategy.

The petitioner’s attorneys were given a year after the hearing to request the lab notebooks from the UK. DoJ attorneys offered to join in the request and the Special Masters wrote a letter of support for the request. The petitioners never filed an application in an attempt to obtain the documentation.

The DoJ attorney stressed again that the Special Master stated that he didn’t need the testimony from Prof. Bustin or some of the other information to make his decision.

I keep thinking that in many ways the Special Master should have been present in this appeal. Both Ms. Chin-Caplan and the DoJ attorney spent a considerable amount of time discussing what the Special Master thought and did. I realize that is not how appeals work, but as the appeals judges keep saying, this is not supposed to be an adversarial procedure. The goal is to bring in all the information and weigh it

One of the judges made a short speech about how scientific opinion progresses and that new data, new techniques could emerge which might support the petitioners. The DoJ attorney noted that the Courts can not wait indefinitely for the science. The petitioners deserve to have cases settled.

First, this is precisely why the evidence standards in the vaccine court are low. The idea is to give the petitioners the chance to win cases before the evidence is in. This is what happened in the DTP cases in the early phases of the vaccine court. Many cases were decided–for the petitioners, mind you–which later evidence showed were not supported. Second, this is not the purview of the appellate court. They shouldn’t be deciding on the merits of the evidence but on procedural questions. Third, as time progresses, the MMR causation theory has only become more implausible. The Hornig study, for example, came out after the Cedillo trial and was a clear rebuke of the early papers by Wakefield’s team

At one point, the DoJ attorney suggested that the underlying data would have buttressed Prof. Bustin’s testimony and she wishes she did have it. One judge, quite rightly in my opinion, corrected her with “how do we know that?” The Judge asserts that Prof. Bustin relied upon the documents to determine that Unigenetics was “a bad laboratory”

I would disagree at this point. The lab notebooks were *part* of the data Prof. Bustin used to form his opinion. But, they were not *all*

Ms. Chin-Caplan claims that she would have joined the DoJ in their attempt to obtain the documents had she known they were attempting that. One judge pointed out that she was given a year after the hearing to obtain the documents and failed to even make the attempt.

I don’t see how Ms. Chin-Caplan aiding the DoJ in their attempt would have changed what she is claiming it would have changed. She demonstrated that she was unable to obtain the documents on her own, so her expertise would not have been helpful. What this would have done is signaled to her 4 months in advance that the DoJ planned to challenge the quality of the Unigenetics laboratory. Frankly, that should have come as no surprise. There was much criticism of the Unigentics laboratory and the resutls in the public arena. The petitioners were aware of the UK litigation as they had also attempted to get data from that proceeding–and some of the petitioner’s experts had worked on the UK litigation.

Ms. Chin-Caplan argues that the one year she was given to obtain the documents was not enough because it was “an impossible task”. One of the judges points out that she has no way of knowing it was impossible since she didn’t try.

Ms Chin-Caplan stated that she didn’t want to waste the taxpayer’s money on an attempt to get the documentation since she wasn’t sure it could be obtained. She argues that it would be difficult because it involved possibly two foreign jurisdictions.

This is a very weak argument. First, the question of whether she was sure or not really doesn’t apply. The only thing that would apply is if she was sure are request would be denied. Second, the idea that she was saving the taxpayer’s money doesn’t really work. The costs of the appeals far outweigh the savings involved. Third, the DoJ had already shown that it could obtain documents from the UK litigation in a matter of four months. The DoJ offered to assist the petitioners, but they apparently did not avail themselves of that opportunity.

Another observation: the petitioners relied upon the Unigenetics laboratory. This is a laboratory which refused to be allow standard inspections to be come an accredited laboratory. It strikes this observer that it was the responsibility of the petitioners to obtain the laboratory notebooks. Without them, the DoJ was unable to effectively cross examine their witness who was claiming that Unigenetics was a good laboratory. That expert, Dr. Kennedy, took part in the UK Litigation, so he too was relying at least in part on data which was not entered into evidence.

The Judge asked Ms. Chin-Caplan if she could have made her case if Dr. Bustin’s testimony were excluded. Ms. Chin-Caplan claimed that she could

this is counter to what the special master who heard the case and wrote the decision *clearly* wrote in that decision

I think it is safe to say that *neither* the DoJ *nor* the petitioner’s attorney came away without some very tough scrutiny by the judges.

More on this appeal can be found in a piece on the VaccinesWork blog, Appeals Won’t Succeed – Olmsted Isn’t Honest

Even though I give away the ending of his excellent post, I quote it here:

The Court of Appeal panel in Hazlehurst faced roughly the same arguments as the Cedillo panel. The Court of Appeal reviews the trial court decision ‘de novo’, or brand new. If they don’t like the trial court decision, they replace it with theirs. However, the appeals court and the trial court can’t merely replace their judgment for the Special Master. All quotes below are from the Court of Appeals decision in Hazlehurst.

By statute, the Court of Federal Claims may set aside the special master’s decision “only if the special master’s fact findings are arbitrary and capricious, its legal conclusions are not in accordance with law, or its discretionary rulings are an abuse of discretion.”

Appeals courts are very limited in what they can do when they disagree with the facts decided by a trial court (in a criminal matter) or the medical facts (before the Special Master). But normally the Court of Appeal can substitute its views on admissible evidence for that of the trial court (criminal court) or the Special Masters. That isn’t the case here, because following the statute that governs the Vaccine Court, Rule 8 states:

In receiving evidence, the special master will not be bound by common law or statutory rules of evidence but must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.” Vaccine R. 8(b)(1) (2009).

Even if the Court of Appeals thinks that the Special Master was wrong when letting in Dr. Bustin’s testimony after giving the plaintiffs a year to apply to the British for access to the reports, that isn’t enough for them to substitute their opinion for that of the Special Master.
So there is near zero chance that the appeal would succeed. Dan Olmsted should have said so and explained why.

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