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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.

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.

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.

Audio of the Cedillo appeal part 1

15 Jun

The vaccine court case of Michelle Cedillo is apparently the last one of the Omnibus Autism Proceeding which is still undergoing appeals. I wrote about the appeal recently on LeftBrainRightBrain, but those were responding to second-hand accounts of the hearing.

With thanks to commenter Anne, the audio is here:

Cedillo appeal arguments

Below are notes I took on the first part of the hearing–the part where the lawyer from the Michelle Cedillo (also representing the rest of the petitioners) was speaking. I’ll get to the second half shortly. I tried to put my own commentary in italics.

Suffice it to say, the notion that the petitioners presented compelling arguments and the judges were entirely favorable to them isn’t born out from the audio.

Ms. Chin-Caplan (attorney for the petitioners, including Michelle Cedillo) argued that the rules of the civil procedure do not apply in the vaccine court and that the government used them as “a club and a shield”.

She complains that the government required them to go to a foreign jurisdiction (the UK) to obtain documents.

I found that odd in light of the fact that the petitioners did try to obtain documents from the UK as early as 2004.

In response to the complaint that the Special Masters required the petitioners to work with this foreign jursidction, the judge asks if the petitioners filed a motion (under rule 26) to compel the government to produce the documents. Ms. Chin-Caplan argued that the Federal rules of procedure do not apply in the vaccine court. The judge responded “that’s not quite true”. Under rule 7 of the vaccine rules, Ms. Chin-Caplan could have asked that the Federal rules be followed. The judge asked if the petioners made a motion to follow those rules.

The judge asks, since they wanted the underlying data why didn’t Ms. Chin-Caplan ask the Special Masters to “please compel the government to bring in the underlying data”. Rules were in place to do that, but the petitioners didn’t do this. Ms. Chin-Caplan discusses that they worked with counsel in the UK for advice on how to proceed in the UK. However, they gave up before filing for the documents.

Ms. Chin-Caplan argues that lack of due process was “pervasive” in the proceeding. One judge asks what other pervasive violations of due process existed. She referred back to the same situation about Dr. Bustin.

In other words, she dodged the question of “pervasiveness”.

Judge–weren’t you given the opportunity to follow-up and to question and challenge the testimony? Ms. Chin-Caplan talks about how new information was presented at the hearing.

She doesn’t discuss the opportunity to challenge the testimony in post-hearing briefs.

Judge–points out that the petitioners didn’t follow through on all avenues to get the material from the UK.

The petitioners abandoned the opportunity to request the material from the UK based on advice from the counsel they consulted with in the UK. In other words, they didn’t actually try to get the courts in the UK to unseal the documents.

Judge Lyn notes that there was a concession that Mr. Conway (Ms Chin-Caplan’s colleague in this case) conceded that the lack of access to these documents did not prejudice the case.

Ms. Chin-Caplan is stuck trying to argue that her own colleague’s concession was incorrect.

Ms. Chin-Caplan argued that the test-cases were supposed have the “general causation” arguments only made during the Cedillo hearing, not the Snyder hearing. Thus, when Dr. Rima testified in the Snyder hearing, council for the Cedillos were not present. Ms. Chin-Caplan argues that Dr. Rima presented a calculation based on information about Michelle Cedillo and that this was in error. She further argues that since she was not present for this hearing, she didn’t know about that until the decision was handed down and it included reference to this testimony.

I find it very odd that her argument is that she wasn’t following the other test cases in the Omnibus.

Ms. Chin-Caplan argues that she submitted the alleged Rima miscalculation–and added more post-hearing information that should have been admitted. This was filed for reconsideration of the decision. This includes a textbook by Prof. Zimmerman of the Kennedy Kreiger Institute and a paper.

The Judges point out that much of the information was available before the decisions were handed down. Ms. Chin-Caplan argues that the Special Master didn’t have time to read the textbook (it came out a month before the decisions).

One of the judges points out that the petitioners would still have a difficult time with the present state of the science proving their case.

Ms. Chin-Caplan notes that the Althen standard: that they have to present a plausible theory of events and have a timeline.

Ms. Chin-Caplan makes a statement I have a difficult time parsing: “Plausibility to some people for whatever reason seems to mean “possible”. But plausibility in the scientific and medical world means that it makes sense from a thinking it through from a scientific and medical standpoint that this can occur.”

Ms. Chin-Caplan discusses the theory they have for MMR causing injury in Miss Cedillo. A judge points out that Ms. Chin-Caplan appears to asking them to reweigh the evidence, which isn’t their job.

I would argue that Ms. Chin-Caplan and the others in the OAP did not present a plausible theory for how MMR would cause autism. Multiple witnesses for the government showed how each leg of their theory was implausible.

Another appeal heard in the Autism Omnibus

14 Jun

Part of the United States Court of Federal Claims includes the “vaccine court”, where claims against the government are heard regarding vaccine injuries. Probably the most well known activity of the vaccine court, especially to readers of LeftBrainRightBrain, is the “Omnibus Autism Proceeding“. The Omnibus comprises over 5,000 families claiming vaccine injury resulted in autism. Rather than hear all these cases individually, both sides agreed to first hear “test cases” where the stories of six children were heard to answer the question of whether vaccines induced autism in those children and to decide whether the general question of whether vaccines cause autism could be addressed. The first three test cases presented the argument that the MMR vaccine, either alone or with thimerosal from other vaccines, could cause autism. The next three cases presented the argument that thimerosal alone could cause autism.

The Omnibus is back in the news, in a small way, after another appeal for the Cedillo test case was heard last week. The attorneys and the bloggers are concentrating on whether the testimony and expert reports of Prof. Stephen Bustin should have been allowed. I’ll go into the detail about this argument below. It is worth saying at the outset that this argument is likely to accomplish nothing, whether they win or lose. The Special Master who decided the Cedillo case and the judge who heard the first appeal both stated, clearly, that the decision to deny the Cedillo claim would be the same without Prof. Bustin’s testimony and report.

That is worth repeating: win or lose on this point in the appeal, the Cedillo’s still do not have a compelling case that the MMR vaccine causes autism.

Before going any further, it is worth stopping and recognizing the human side of this proceeding. The “test cases” are six children whose families agreed to let their stories be heard and analyzed in public. They went into this with faith in their positions, but without the knowledge of the legal outcome. When the decisions were handed down against them (yes, they lost), they didn’t have the opportunity to change their arguments. They were committed. So, in two big ways, these are brave families. Agree or disagree with the science they depend upon, they had some guts to step forward as they did.

It is also worth noting that no one gets wealthy from successful claims in the Court. Settlements are typically around US$1 million. While this sounds like a lot, the purpose is to pay for the needs of the injured and to set up an annuity which will supplement the government support already in existence for the disabled. Most readers to this blog will have an idea to how far that support goes.

The Omnibus hearing and the appeals

The first of the test cases heard was that of Michelle Cedillo. Miss Cedillo is a severely handicapped girl with multiple disabilities. Her case was heard in June 2007. The decision, by Special Master Hastings, was handed down in February 2009. The Cedillo family appealed and the case was heard by a Judge in the U.S. Court of Federal Claims, Judge Wheeler, whose decision in August 2009 went against the Cedillo family. The Cedillo family appealed again, this time to the U.S. Court of Appeals for the Federal Circuit. Their appeal was heard on June 10 before judges Newman, Linn and Dyk.

The Court of Appeals for the Federal Circuit is probably the last appeal for the Cedillo family. Should this go against them, they have the right to appeal to U.S. Supreme Court. But the Supreme Court is not required to hear their case. In fact, the Supreme Court usually chooses cases which decide points of law. The arguments by the Cedillo family are more questions of procedure and, as such, I would expect the Supreme Court would refuse to hear any appeal. But, that is getting ahead of ourselves. Right now, we still haven’t heard the decision from the Appeals Court.

Public Responses to the Recent Appeal

What we have heard is some minor publicity about the hearing in the Appeals Court. The Age of Autism blog has Olmsted on Autism: Day in Court and one of the Examiner blogs has Oral arguments made in Cedillo Omnibus Autism Proceeding mercury and MMR vaccine test case appeal.

I haven’t heard the arguments made in court. I wish I had because in my experience there is a fairly large gap between what I’ve heard in past proceedings and how they are portrayed on the net. A fairly egregious example was in the portrayal of an expert witness for the Cedillos, Dr. Vera Byers. When she testified in 2007, someone was portraying her as coming across with the gravity of Dame Judi Dench (who plays “M” in the James Bond movies, amongst other roles). During the hearing, Dr. Byers was found to have seriously padded her resume, claiming she worked at the prestigious University of California San Fransisco when, in fact, she only used their libraries and attended their parties. She also accused the Department of Justice lawyer of “making faces” at her. I did not think of Dame Judi Dench when I heard her testimony.

Following the original hearings for the Cedillo case, many bloggers in the vaccines-cause-autism groups were optimistic. They felt that they had made a strong case and they would prevail, complete with imagery of “Dark Towers” being brought down by bolts of lightening. From my perspective, such cheer-leading seemed to border on cruel given the very weak case made to support the general question of MMR causing autism.

Given this background you would probably not be surprised that I look at the optimistic reports coming out of last week’s appeal with a somewhat skeptical eye. Which begs the question, “what was said” by these bloggers? From Mr. Olmsted’s piece, here are two quotes.

The first is from one of the attorneys working with the Cedillo family:

“I have a very positive feeling about the federal judges,” said Sylvia Chin-Caplan, who argued the appeal.

The second quote comes from an attorney who blogs for the Age of Autism blog and who, I believe, has a child who is a claimant in the Omnibus:

“I leave with the sense that the judges were very troubled that the government had not acted in good faith,” said Mary Holland. “Those judges were very troubled by what the government’s done – very troubled.”

The argument for the appeal: Prof. Bustin’s testimony

So, what are the judges supposedly “troubled” by? Well, this has to do with part of the appeals argument by the attorneys for the Cedillo family: the testimony of Prof. Stephen Bustin.

Professor Bustin is a world expert on a technique called polymerase chain reaction (PCR) which he describes as

Real-Time PCR is a variation of the polymerase chain reaction (PCR) that allows simultaneous (i.e. in real-time) amplification and detection of DNA templates. Because it is used to quantitate DNA, it is often abbreviated to qPCR, although that abbreviation is not universally accepted.

PCR played an important rule in the Omnibus. PCR was used in attempts to identify measles in tissue samples taken from autistic children’s bowels. One of the key papers for the families in the Omnibus was written by Uhlman et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. The Uhlman paper concluded “The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. ” One of the co-authors on that paper is Professor J J O’Leary, whose laboratory, Unigenetics, performed the tests on samples sent from the group headed by Andrew Wakefield in London. The same laboratory was used to test samples taken from Michelle Cedillo.

The presence of measles virus in the tissues is key to the theory argued in the Omnibus. This was made very clear when the expert reports were filed, in February of 2007. At that time, the Department of Justice attorneys sought information to rebut the “persistent measles in the gut” argument. One source they sought was information filed in the United Kingdom for the MMR litigation that was held there. In specific, they sought the report by Prof. Bustin, who had testified in that litigation. Those reports are sealed and require special permission to obtain. The DoJ attorneys received the first of those reports on May 31, 2007, 1 hour after receiving it, but only 12 days before the start of the Cedillo hearing. One week later, the DoJ filed two more reports by Prof. Bustin.

The attorney’s for the Cedillo family argued that they didn’t have time to assimilate such technical information and prepare a good response. Further, they argued that the reports were submitted after a deadline imposed by the Special Master. The Special Master allowed Prof. Bustin to testify and to submit his expert reports. The Special Master argued that the admissibility of the testimony and reports could be decided after the hearings.

This history and greater detail are summarized in the Wheeler decision denying the first Cedillo appeal.

Was Prof. Bustin’s Testimony Damning to the Case?

Professory Bustin is possibly the word’s number one expert on PCR. Not only that, he was given access to the Unigenetics laboratory and the notebooks they kept. He found that the Unigenetics laboratory was missing a key step in the process. PCR tests DNA. Measles is an RNA virus. So, there must be a step to turn the RNA into DNA or PCR won’t work.

At the time Unigenetics were testing samples for the Uhlmann paper and the sample from Michelle Cedillo, they weren’t using RNA–>DNA step. Whatever they were detecting, it wasn’t an RNA virus and, hence, it wasn’t measles.

Prof. Bustin also testified that at that time Unigenetics was not using “controls” correctly, making interpretation of their results problematic at best.

Prof. Bustin also testified that the laboratory notebooks had been altered after the fact.

Prof. Bustin also testified that Unigenetics found the same results from two different types of samples (fresh-frozen and formalyn fixed). That could only happen if they were detecting contaminants.

And the list of errors at Unigenetics goes on. (There is an extensive summary in the Hastings decision for the Cedillo case)

These are only parts of the testimony. But, yes, it is safe to say that Prof. Bustin’s testimony hurt the case the attorneys for the Cedillos were trying to make.

Would the case have been decided for the Cedillos had Prof. Bustin’s testimony been excluded?

As noted at the outset of this piece, Prof. Bustin’s testimony is not key to the decision to deny the claim of the Cedillo family. It also isn’t key to denying the question of general causation (does MMR, in general, cause autism).

Special Master Hastings has a section of his decision entitled, “Even if I were to disregard Dr. Bustin’s expert reports and hearing testimony, all my conclusions in this case would remain the same.” I quote that section in its entirety below:

Finally, even if I were to completely exclude and disregard all of Dr. Bustin’s reports and all of his hearing testimony, nevertheless all of my conclusions in this case would remain exactly the same.

First, the testimony and reports of Dr. Bustin were relevant chiefly in establishing my conclusion discussed at pp. 58-60 above, i.e., that there were severe problems with the facilities and procedures of the Unigenetics laboratory. But even concerning this narrow point, Dr. Bustin’s testimony was not the only evidence. Dr. Rima provided extensive, convincing evidence to the same effect, and Dr. MacDonald provided some corroboration as well. (See discussion at pp. 52-54, 58-59 above.) I would have reached the same conclusion, that there were severe problems with the Unigenetics facilities and procedures, based just on the evidence supplied by Dr. Rima and Dr. MacDonald, even without any information from Dr. Bustin.

Second, even if there had been no testimony from Dr. Bustin, Dr. Rima, Dr. MacDonald, or any other expert who participated in the British litigation, concerning the problems with the Unigenetics procedures and facilities, nevertheless I still would have concluded that the Unigenetics testing was not reliable. That is, as explained above (p. 77), the most important points in my rejection of the Unigenetics testing were (1) the fact that the laboratory failed to publish any sequencing data to confirm the validity of its testing, (2) the failure of other laboratories to replicate the Unigenetics testing, and (3) the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.” The testimony by Drs. Bustin, Rima, and MacDonald, about the many problems with the Unigenetics laboratory and procedures, was merely a secondary, additional reason to doubt the reliability of the Unigenetics testing. Accordingly, I would still have found the Unigenetics testing to be unreliable even if there had been no reports or testimony at all from Drs. Bustin, Rima, or MacDonald.

Accordingly, for all the reasons set forth above, I conclude (1) that there is no valid reason for me to disregard the evidence supplied by Dr. Bustin, and (2) that even if I did disregard that evidence, my conclusions concerning all of the issues in this case would remain the same.

Testimony of Nicholas Chadwick

One reason that the Special Master could be so decisive on the unreliability of the Unigenetics laboratory was the fact that other groups were unable to replicate those findings. One of those researchers was Nicholas Chadwick, a post doctoral researcher in Wakefield’s own group. Dr. Chadwick used PCR to test biopsy samples from autistic children–many of whom were a part of the now-retracted Lancet paper by Wakefield’s team–and found that they were negative for measles virus.

Dr. Chadwick’s Ph.D. thesis includes results from “Autistic enteropathy samples. Biopsies, PBMCs and Vero/PBMC cocultures were analysed from 22 patients with autistic enteropathy and 6 controls.”

He found

Results. Hybrid capture and RT-PCR could detect 104 molecules of a measles RNA transcript added to control tissue homogenates. The fidelity of NASBA, in terms of its nucleic acid error rates, was found to be comparable with that of RT-PCR. All samples were found to be positive for a housekeeping RNA species and internal modified positive control RNA. None of the samples tested positive for measles, mumps or rubella RNA, although viral RNA was successfully amplified in positive control samples.

Conclusion. The results do not support previous data implicating persistent measles virus infection with the aetiology of IBD or autistic enteropathy.

He studied gut biopsy samples, cerebral spinal fluid samples and blood samples.

This isn’t a separate group and different children. This is Mr. Wakefield’s own hospital, someone he was in contact with. It is likely that some of these children’s samples were also tested by Unigenetics and with false positive results.

Dr. Chadwick’s expert report and testimony are online.

Should Prof. Bustin’s Testimony have been Allowed?

Prof. Bustin’s report was submitted very close to the start of the Cedillo hearing. In fact, it was past a deadline imposed by the Special Master. The attorneys for the Cedillos have argued that they were unable to prepare a response to such a technical report and that they didn’t have access to the lab notebooks which Prof. Bustin relied upon.

Let’s take this in stages.

First, yes the report was submitted past the deadline. So were reports submitted by the attorneys for the Cedillos. The vaccine court is supposed to be flexible in allowing evidence in.

How about the idea that the attorneys for the Cedillos were unable to prepare a case in time? First, page back and recall how all this got started. The Cedillo’s attorneys submitted expert reports which relied upon the results of the Unigenetics laboratory results. Not only that, but the expert who submitted that report, Dr. Ronald Kennedy. Kent Heckenlively, blogger for the Age of Autism, wrote in a post following Prof. Kennedy’s testimony, “Dr. Kennedy is familiar with the Unigenetics Lab of Dr. John O’Leary and Dr. Laura Shields at Trinity College in Dublin, Ireland where measles virus RNA was diagnosed in the cerebral spinal fluid of Colten Snyder.” (Colten Snyder was one of the other “Test Cases”)

So, the attorneys for the Cedillos not only had an expert on their team to discuss PCR, but their expert was familiar with the Unigenetics laboratory. Their report was filed four months before Stephen Bustin’s reports and, presumably, their team had access to information from well before that.

How about the idea that the attorneys for the Cedillos didn’t have access to the lab notebooks which Prof. Bustin reported upon? First, it is clear that Prof. Bustin’s analyses did not rely solely on the lab notebooks. Some of the problematic results were public (from the paper) and other information he obtained in his 1,500 hours spent analyzing the Uhlmann work. Yes, 1500 hours.

The whole argument begs the question: how are the Cedillo’s attorneys and their expert (Prof. Kennedy) so confident of the Uhlmann results if they haven’t seen the notebooks?

One of those attorney’s is quoted:

Chin-Caplan told Examiner.com, “Two reports that he submitted on behalf of the government were of such technical matter and so incomprehensible that at the very least a motion to continue the hearing should have been entertained and it wasn’t.”

I am again at a bit of a loss. Why were Ms. Chin-Caplan and her team unprepared to respond to Prof. Bustin’s reports? She and her team were the ones who were admitting PCR testing as evidence.

Ms. Chin-Caplan is also quoted:

“The fact that they went over there (to the U.K.) secretly four months before the hearing to try and get these documents without giving me notice that they were going to do this leads me to think that they wanted to examine those documents without me being present,” Chin-Caplan told Examiner.com. “And that violates the concept of fundamental due process as far as I’m concerned.”

The idea of obtaining information from the U.K. litigation was not a surprise to the Cedillo’s attorneys. They had attempted as early as 2004–three years before the hearing–to obtain reports from the U.K. The idea that the DoJ attorney’s “wanted to examine those documents wihout me being present” is totally at odds with the fact that the DoJ submitted the first report 1 hour after receiving it. One hour.

One might ask why Ms. Chin-Caplan didn’t call upon, say, Andrew Wakefield or others to write reports or to serve as an expert witness. Mr. Wakefield is on the list of potential experts. Mr. Wakefield is one of the authors of the Uhlmann paper. Of course, the answer is that Mr. Wakefield, father of the MMR causes autism hypothesis, is not a very credible witness.

Friend of the Court Brief

Much of the argument for the appeal is summarized in a “Friend of the Court” brief.

That brief concentrates much space to the reliability of the O’Leary lab results. It introduces new “data”

Michelle submitted further compelling evidence of the reliability of the O’Leary lab results in her motion for reconsideration. She submitted a new study on the recovery of measles RNA from the gut tissue of autistic children. The multi-center Hornig study,57 relying on laboratories at HHS’s own Centers for Disease Control, Columbia University and Dr. O’Leary’s laboratory at Trinity College were all concordant in finding measles RNA in one clinical subject and one control, again showing the O’Leary laboratory’s reliability.

The Hornig study was an attempt to recreate some of the Wakefield group’s studies. The study was much more careful than Wakefield’s team’s efforts. It was discussed on this blog at that time.

I am always amazed when people try to use the Hornig study to support the MMR-causes-autism hypothesis. The paper concluded:

This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure

As far as supporting the idea that the O’Leary laboratory was reliable, it is far from convincing. There is a vast difference between how a laboratory performs in, say, the late 1990’s and ten years later after facing much criticism and while under intense scrutiny for accuracy. In other words, it is very possible that the O’Leary laboratory’s methods were different for the Hornig study than used for the Wakefield/Uhlmann studies.

Summary

It seems unlikely to this observer that the Cedillos will win this appeal. They rely on discounting the testimony of Stephen Bustin. The arguments to throw out his testimony have not proven persuasive in a previous appeal. More importantly, the Court made it extremely clear that the decision would be the same whether or not Prof. Bustin’s testimony was allowed. The public statements being made about this appear to be coloring the facts somewhat to create an image of impropriety by the government. Also, those making public statements appear to ignore the fact that even without Prof. Bustin’s testimony, the case was not close.

At every step along the process of the Omnibus Proceedings, public statements have been heard suggesting the families had a strong case. In my opinion, this has been a disservice to those families. I worry that this is yet another instance of building up false hope for the families in the Omnibus.

US Court of Appeals denies vaccine court case

14 May

The first of the vaccine court autism cases has been denied by the United States Court of Appeals, Federal Circuit. The Vaccine court (or, more accurately, the U.S. Court of Federal Claims) grouped the autism claims into an “Omnibus”, something like a class action case, where evidence to prove vaccines cause autism was presented in a few “test cases”, rather than hearing all the cases individually. The Omnibus Autism Proceeding heard six test cases, three on the theory that the MMR vaccine causes autism and three on the theory that thimerosal (a mercury containing perservative) causes autism.

The appeals decision is for the test case of Yates Hazelhurst, one of the MMR test cases. The case was summarized by the Special Master who decided the case:

[P]etitioners assert that the measles component of the MMR vaccine causes an immune dysfunction that impairs the vaccinee’s ability to clear the measles virus. Unable to properly clear the measles virus from the body, the vaccinee experiences measles virus persistence which leads to chronic inflammation in the gastrointestinal system and, in turn, chronic inflammation in the brain. Petitioners argue that the inflammation in the brain causes neurological damage that manifests as autism.

The Special Master (essentially the Judge in the vaccine court) denied the claim. The family appealed to the Court of Federal Claims, who upheld the decision. The recent decision is from the United States Court of Appeals, Federal Circuit, making this the second appeal affirming the original decision.

The family appealed on the basis, as the appeals judge put it:

On appeal to this court, the Hazlehursts argue that the special master improperly relied on certain evidence that should have been excluded and disregarded other evidence that should have been considered.

The MMR theory for autism causation relies on the notion that the measles virus from the vaccine persists in the guts of children. This, in turn relies on research by Dr. Andrew Wakefield’s team and in particular, the Unigenetics laboratory. The government brought in a witness, Dr. Stephen Bustin, to refute the validity of the results from the Unigenetics lab. Dr. Bustin’s testimony and level of expertise were very clear in showing that the Unigenetics results were faulty.

The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics. In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus. She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound. In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.

The Special Masters allowed the petititioners (including the Hazelhursts) time to rebut Dr. Bustin’s testimony, through cross examination and through documentation from the UK MMR litigation. The petitioners did not avail themselves of this opportunity.

Over objection, the government sought to introduce Dr. Bustin’s reports and testimony regarding the Unigenetics laboratory, which, by that time, had gone out of business.[ 2 ] The special master in the Cedillo case provisionally admitted the evidence. The three special masters in the omnibus proceeding then deferred decision on whether to rely on that evidence and stated that they would “favorably consider joining in a request” by the petitioners “for the release of relevant reports” from the UK litigation. The record remained open for more than a year following the Cedillo hearing to afford the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-examination of Dr. Bustin, and to obtain documents from the British court. However, none of the petitioners recalled Dr. Bustin for further questioning or applied for access to any of the materials from the UK litigation.

The Hazelhurst’s argued that evidence should have been allowed that was not. In particular, they argued that some unpublished results demonstrate the persistent measles theory.

The special master further concluded that the unpublished and preliminary findings of the Walker group should not be accorded significant weight. She observed that Dr. Hepner had declined to “draw any conclusions about the biological significance” of the investigators’ findings and had testified that negative controls were not included with each experimental run. The special master also noted that the petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus, as opposed to the vaccine-strain measles virus, which is far less virulent and replicates poorly in the human body.

In the end, the appeals judge ruled that there was no reason to overturn the original decision:

Because we find no error in the special master’s consideration of the evidence, we also find no error in her decision to discount Dr. Corbier’s opinion that the MMR vaccine caused Yates’s autism. By Dr. Corbier’s own admission, his opinion depended heavily on the reliability of the scientific studies purporting to show measles virus persistence in autistic children.

Compensation under the Vaccine Act is limited to those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. The special master concluded that the Hazlehursts’ evidence failed to demonstrate the necessary causal link, and the petitioners have not identified any reversible error in the special master’s decision reaching that conclusion.

The petitioners now have the choice of appealing to the U.S. Supreme Court. As noted above, the Supreme Court hears cases which help define laws and this does not appear to be such a case. It would seem unlikely, then, that the Court would agree to hear this case. If so, this is the end of the appeals for the Hazelhurst’s in their case against the U.S. government. The next step would, then, be to take their case to civil court against the vaccine manufacturers. Such cases have not been successful so far. Civil cases require a higher level of evidence and expertise than the vaccine court. Having failed in the Federal Court, where the rules are more favorable to the petitioners, it would seem a difficult battle to win the case in civil court.

Bogus Urine Metals Testing Fails In Vaccine Court

13 Mar

The Thimersoal “test cases” in the OAP relied on bogus urine mercury testing. Among many other common problems the petitioners had in providing any sound scientific support for the notion that mecury can cause autism, that, was at least in part, the apparent conclusion of all three of the special masters.

I just skimmed through the recent decisions by the US Court Of Federal Claims in the Thimerosal “test cases” that were part of the Omnibus Autism Proceeding, and the expert testimony provided by Dr. Brent (respondent) in this regard is pretty clear:

From the Mead Decision

When specifically asked about the urine mercury tests that were performed on William, Dr. Brent said that the tests “showed pretty much exactly what you’d expect for the normal population, that their unprovoked specimens are normal. Yet, when they give chelators, most of [mercury excretion results] are increased.” Id. at 1852-1853. Dr. Brent expressed a concern about the use of data in this way to suggest that a condition exists that, in fact, does not. See id. at 1853. He stated that “it’s data like this that has been used as an excuse to subject these children to chelation therapy where the data supports [a finding] that their urine mercury status is totally normal.” Id. at 1853.

From the King Decision

Moreover, Dr. Brent explained that when the results of mercury testing of Jordan, both provoked and non-provoked, are viewed in their entirety, they are exactly what one would expect from an individual without any mercury-related problem. That is, Jordan’s non-provoked test results were within the normal range for non-provoked testing. (Tr. 1852-53, 4340.) At the same time, while his provoked results were outside the normal range for non-provoked testing, that is not surprising since the provocation/chelation process is designed to specifically provoke an increased excretion of metals. (Tr. 1852-53, 4340-41, 4347.) As Drs. Brent and Fombonne explained, administration of a chelating agent to anyone, autistic or not, mercury-poisoned or not, will always be followed by increased excretion of mercury.118 (Ex. M, p. 74; Tr. 1852, 4340-41, 4343.)

Interestingly, the added scientific clarity of the special masters with regard to bogus urine metals testing is also present to some degree in all three test cases:

Here’s one example from the Mead Decision

Moreover, a subsequent study, as reported in the 2007 Soden article filed as RMRL 458,150 could not confirm the 2003 Bradstreet study results. See Mead Tr. at 1844. The investigators found that “DMSA provoked excretion testing did not produce evidence of an excess chelatable body burden among the autistic [study] participants.” RMRL 458 at 480. The investigators concluded that “[i]n the absence of a novel mechanism of heavy metal toxicity or an alternate therapeutic action of chelators, the data presented provide[d] no justification for chelation therapy for the [study] participants.”

Many will remember the conclusion of Soden et al.

“In the absence a proven novel mode of heavy metal toxicity, the proportion of autistic participants in this study whose DMSA provoked excretion results demonstrate an excess chelatable body burden of As, Cd, Pb, or Hg is zero.”

But perhaps the most interesting of all, is the common thread that the reliance upon the bogus mercury testing seems pretty much acknowledged for what it is by both the special masters and the petitioners’ expert:

From the Dwyer Decision

Doctor Mumper’s willingness to rely on Colin’s mercury test results as evidence of high levels of mercury in his body was particularly troubling. She admitted that his results were not typical of those she saw in other autistic children. She admitted that she knew of no research into normal mercury excretion levels after chelation against which Colin’s one positive mercury test could be measured.741 It appeared that regardless of the results for mercury levels, Dr. Mumper was willing to opine that they reflected mercury’s role in ASD.

From the King Decision

In short, a careful analysis of the record demonstrates that there is no valid basis for Dr. Mumper’s view that the results of mercury excretion testing on Jordan King offer support for a conclusion that thimerosal-containing vaccines played a role in causing Jordan’s autism. To the contrary, the evidence supports a conclusion that Dr. Mumper’s reliance on such mercury tests has no basis in science or logic. Indeed, upon cross-examination even Dr. Mumper acknowledged that there is no particular profile or pattern of post-provocation test results that points to a finding that a child has mercury-induced autism. (Tr. 1555-60, 1568-69.) When pressed, Dr. Mumper could not even suggest an example of any type of result on a post-provocation mercury urine test that would not, in her analysis, support a claim of mercury-induced autism. (Tr. 1558-60.) Dr. Mumper’s analysis in this regard was illogical, and completely unpersuasive.119

Yep, regardless of the results of a scientifically meaningless test, it’s the mercury. Right.

Remember, these were the three Thimerosal “test cases”, presumably chosen by the Petitioner’s Steering Committee (PSC) because they offered the best opportunity to introduce good, and representative scientific evidence for the hypothesized role of thimerosal in the etiology of autism. It looks like they failed miserably, and this doesn’t seem surprising when it’s clear the cases leaned on at least one form of laboratory testing that’s clearly scientifically meaningless.

It won’t be surprising when many of the die-hard anti-vaccine and “alternative” autism medicine brigade ignore the fact that bogus urine toxic metals testing just had a bright light shined on it by the vaccine court. They’ll be likely to claim some form of conspiracy or politics about the cases, despite the fact that the spotlight revealed an apparent decision-making tool of many a “DAN! doctor” to not only be worthless in medicine, but also worthless in court.

On a related note, there has been recent news that a couple of “DAN! doctors” are facing a lawsuit in which bogus urine toxic metals testing is called out directly. Aside from numerous other problems they face in the complaint, it should be interesting to see how the defendants (Dr. Dan Rossignol, Dr. Anjum Usman, and Doctors Data, Inc.) explain the potential role of comparing chelator-provoked urine metals levels to a non-provoked reference range. If the three test cases in the OAP are an indication of the state of actual scientific support for such testing, the defendants would seem to have plenty to worry about.

Additional reading:

Mead v. Secretary of Health and Human Services Case No. 03-215V
King v. Secretary of Health and Human Services Case No. 03-584V
Dwyer v. Secretary of Health and Human Services Case No. 03-1202V
Thimerosal-Autism Test Cases Dismissed
Doctors sued over ‘dangerous’ autism treatment
Suing DAN! practitioners for malpractice: It’s about time
How the “Urine Toxic Metals” Test Is Used to Defraud Patients
24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study

Vaccine Court Decision: thimerosal containing vaccines do not cause autism

12 Mar

The decisions are in for the second phase of the Omnibus Autism Proceedings–the “vaccine court” trials to determine if autism can be considered as a vaccine injury. The first set of decisions were handed down last year (those regarding the MMR as a causative agent). This set explored whether thimerosal, the mercury containing preservative formerly used in childhood vaccines, could cause autism.

The decisions are long, and I expect there to be much discussion. Below are the final paragraphs from the decisions. These are for the three “test cases”, the hearings held for three specific children who petitioned for compensation on the basis of autism as a vaccine injury. They are clear and decisive: the evidence does not support thimerosal containing vaccines as causing autism, in general or in these three children in specific.

Mead:

Petitioners’ theory of vaccine-related causation is scientifically unsupportable. In the absence of a sound medical theory causally connecting William’s received vaccines to his autistic condition, the undersigned cannot find the proposed sequence of cause and effect to be logical or temporally appropriate. Having failed to satisfy their burden of proof under the articulated legal standard, petitioners cannot prevail on their claim of vaccine-related causation. Petitioners’ claim is dismissed, and the Clerk of the Court SHALL ENTER JUDGMENT accordingly.

King:

Thus, I feel deep sympathy for the King family. Further, I find it unfortunate that my ruling in this case means that the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is certainly my hope that our society will find ways to ensure that generous assistance is available to the families of all autistic children, regardless of the cause of their disorders. Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly,

Dwyer:

Petitioners have not demonstrated by a preponderance of the evidence that Colin’s condition was either caused or significantly aggravated by his vaccinations. Thus, they have failed to establish entitlement to compensation and the petition for compensation is therefore DENIED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk is directed to enter judgment accordingly.

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