Fombonne  The Cedillo Decision

Double Standards

by F. Edward Yazbak, MD, FAAP

1.Double Standards
2. Busting Rules. How a questionable testimony affected so many cases
3. Translation in the Court

1. Double Standards
The long awaited decision in the Cedillo MMR/Thimerosal/Autism case [Theresa Cedillo and Michael Cedillo, as parents and natural guardians of Michelle Cedillo v. Secretary of Health and Human Services - No. 98-916V] was filed by Special Master George L. Hastings Jr. on February 12, 2009.
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It immediately became the ultimate proof that the MMR vaccine and Thimerosal do not cause autism.

I chose not to publicly comment on the case until the plaintiffs’ appeal was decided. Needless to say, I was like many others, most saddened and disappointed to learn recently that the original decision was affirmed. This was even more painful for me because it coincided with the good news from the U.K. about the Fletchers’ case.

I was fully informed about the medical aspects of both cases even though I did not officially participate in the Cedillo litigation.

Special Master Hastings’ statement that the “the petitioners have not demonstrated that they are entitled to an award on Michelle’s behalf” should not be interpreted as meaning that Michelle Cedillo’s autism and multiple health problems were absolutely unrelated to her vaccinations. The statement simply indicates that the petitioners’ experts did not convince the Special Master(s) that the preponderance of the scientific evidence supported the petition.

I have offered expert testimony in litigation involving vaccine injury and am reasonably well informed about the U.S. vaccine injury compensation program. With all due respect to the Special Master(s), it is still my opinion that Michelle Cedillo’s present life-threatening seizure disorder, her serious and disabling gastro-intestinal, ocular and joint findings and her marked regression are somehow related to the MMR vaccination that she received. I am also not convinced that the Thimerosal that was injected into her little body in the first year of life did not seriously affect her immune system and set her up for a more serious reaction to her triple live virus vaccine at 15 months.

Discussing the outcome, Special Master Hastings elaborated: “…The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts…”

It is the “far better qualified” description that I will be discussing here.

In my opinion, two experts for the respondent, Stephen A. Bustin PhD and Eric Fombonne MD seemed to have caused the most damage to the petitioners’ case at the Washington DC hearings.

In “The Expert and Decorum” I questioned whether Dr. Bustin’s testimony should even be considered after he granted an interview and discussed his role and input in the Cedillo case before the Special Masters had decided the case.

I published that article in England because it was there that the interview in question was granted, possibly to influence the Wakefield et al GMC hearings.
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In the following pages, I will discuss certain aspects of Dr. Fombonne’s testimony, the other main witness for the respondent.

Vera S. Byers MD, PhD testified for the plaintiff on Thursday June 14, 2007. [ ]
According to Dr. Byers (p. 862-863), she received a degree in Microbiology (UCLA), a Masters degree in Protein Chemistry (UCLA), an MD degree (UCSF) and a PhD in Basic Immunology (UCSF)

Dr. Byers who had completed a residency in Internal Medicine and a 3-year Fellowship in Immunology at UCSF was also board-certified in Internal Medicine.

All this did not seem to impress Senior DOJ Attorney Vincent J. Matanoski who cross-examined Dr. Byers for the respondent and questioned her expertise in Allergy and Immunology (p. 956):

Q. You’re not certified in allergy and immunology, are you?

A. I’m board eligible. I have not taken the test. Instead, I did the three-year fellowship in clinical immunology and practiced allergy for 25 years

Q. Why didn’t you take the test?

A. Because at that time it was a very long time ago. At that time it only really qualified you to treat allergy, and at that time I thought the practice of allergy was extremely boring and I never planned to do it, so then I went on to do it for the next 25 years.

Q. So you practiced without being certified?

A. I practice, yes. I’m boarded in internal medicine

Q. But you called yourself board eligible

A. Board eligible in allergy immunology yes.

Q. Is board eligible a phrase that’s recognized by the organization that certifies allergists and immunologists?

A. Yes, it is, so therefore if you are filing out an application, for example, like I’m a fellow in the American Academy of Allergy and Immunology. If you’re filling out an application for that they will ask you whether you are boarded in allergy immunology or whether you’re board eligible in allergy immunology

Q. You’ll see on your screen a letter from the American Board of Allergy and Immunology referencing your status with that organization. They note that the board neither recognizes uses nor defines that term board eligible.

A. Okay

Q. So you have been essentially representing that this is a qualification that you have in terms of rendering an opinion about immunology?

A. Yes, I have.

For clarification: Dr. Byers was mentioning the requirements to join the professional association

Dr. Byers was correct. According to the AAAAI web site “Physicians (MD or DO) who have completed an accredited allergy/immunology training program are invited to join the AAAAI.” [ ]

Board certification was not a requirement for application to membership in the AAAAI at the time. It still is not.

The ABAI on the other hand is a Conjoint Board of the American Board of Internal Medicine and the American Board of Pediatrics. According to the Board “All candidates for the ABAI Certification Examination must have successfully completed 24 full-time months of continuous training at an accredited education program.” The Board also stresses “that the responsibility of acquiring knowledge in allergy and immunology rests with the candidate.” [ ]

Again Dr. Byers had a three year fellowship in allergy and immunology and the outstanding program at UCSF is certainly accredited.

Specialty boards, the ABAI included, also offer subsequent exams at regular intervals for “Maintenance of Certification”. [ ]

Obviously if Attorney Matanoski had asked the ABAI “Was Dr. Byers eligible to take your certification examination after her three year fellowship at UCSF if she paid the registration/examination fee?” the answer would have certainly been yes.

A Google search for “Board eligible in allergy and immunology” yielded a list of 27,200 items in 0.30 seconds on August 31, 2010. Another search on the same day for California and Board eligible in allergy and immunology yielded 12,700 items in 0.14 seconds. Evidently many U.S. physicians and organizations use the description to indicate completion of training and expertise in the field.

Furthermore, pursuant to Rule 702 of the Federal Rules of Evidence, testimony of an "expert witness" may be allowed "[i]if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue . . . ." An "expert witness" is defined as "a witness qualified as an expert by knowledge, skill, experience, training, or education . . . ." Id.

In any case, it is clear that the lead attorney for HHS had insisted on June 14, 2007 that in spite of her MD and PhD degrees, her board certification in Internal Medicine and her 3-year fellowship and training in immunology in a renowned U.S. institution, in addition to 25 years of practice in the field of allergy and immunology, Dr. Byers could not mention her “board-eligibility” as an indication of expertise in the field: She needed to have taken the exam and be “board certified”.

On Monday June 18, 2007, Attorney Matanoski started the sixth day of testimony with a long opening statement. [ ]

He was followed by DOJ Attorney Lynn Ricciardella who called Dr. Eric Fombonne, the first expert witness for HHS, to the stand.

Doctor Fombonne was and still is Chairman of the Department of Psychiatry & Head of the Division of Child Psychiatry at McGill University. After listening to his testimony that day and again on June 25, 2007, I must concede that he was an effective expert witness for the respondent. His qualifications, knowledge and experience are not in question here. Only questioned is his interpretation of “Board Certification” and its acceptance.

Dr. Fombonne stood up, raised his right hand and said “I do” when Special Master Hastings asked him “Do you swear to tell the truth, the whole truth and nothing but the truth so help you God.”

Ms. Ricciardella then warned the Special Masters, the audience and those of us listening via the telephone “Before we begin, Dr. Fombonne has a soft voice.”
(p. 1238)

Attorney Ricciardella was right. Listening by telephone, I could not understand what Dr. Fombonne was exactly saying when he was describing his qualifications. The Special Masters apparently did not either and repeatedly asked the witness to speak up and get closer to the microphone.

According to the record, the following was one of the early exchanges between Attorney Ricciardella and Dr. Fombonne (p. 1242):
Q. And why did you decide to specialize in Child psychiatry?
A. Because I had an interest in the childhood antecedence of psychiatric disorders in an adult life and then also a strong interest in neurodevelopmental disorders
Q. Doctor, what certifications do you hold in your field?
A. I have a medical degree and I have full training in child and adolescent psychiatry. I’m the equivalent of board-certified in child and adolescent psychiatry in the French system

With the speed of lightning and without mentioning, at least for the record, which medical school Dr. Fombonne attended, when he actually graduated, where and when he specialized in adult, child and adolescent psychiatry and how many years he had actually spent to achieve his “full training”, Attorney Ricciardella accepted the witness’ self-professed board certification equivalency and endorsed it by asking: “Is that the highest certification in your field?” To which the witness answered “Yes”.

Ms. Ricciardelli’s last question and the witness’ positive answer were now not about training in France but about the highest certification in the field of pediatric and adolescent psychiatry anywhere including the United States.

To me, listening on the phone, things had suddenly become rather strange. When it came to the plaintiff’s expert witness, her extensive post-graduate training did not count. She needed to pay a fee and pass an exam in order to be qualified to testify as an expert witness while the expert for HHS only needed to have an accent and a soft voice and to state that his training was the highest certification in his field.

In addition, Dr. Fombonne’s assertion that he had become a pediatric psychiatrist because of his “strong interest in neurodevelopmental disorders” appeared to contradict his statement in his 2007 CV, that he only “developed an interest for autism” starting in 1986. Indeed a review of his many publications revealed that his first autism-related publication, “Une étude multicentrique sur l'autisme et les psychoses infantiles. Handicaps et Inadaptations”, was published in 1991.

Unlike many other expert witnesses, Dr. Fombonne seems to have always had an easy time in U.S. Courts. In his article titled “Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations” published in the July 6, 2006 issue of PEDIATRICS, Dr. Fombonne declared that he had been an expert witness for certain vaccine manufacturers in U.S. thimerosal litigation “since 2004” in spite of the fact that he had not published anything about the mercury preservative before the July 2006 PEDIATRICS article in question. [ ]

On his first day of testimony at the Cedillo trial, Dr. Fombonne spent an inordinate amount of time analyzing scenes from the videos that had been provided by the plaintiffs. He tried ad nauseam to show that Michelle Cedillo was not perfectly normal before she received her MMR vaccine. He then tried to convince everyone in Court that the girl they had all seen in a wheel-chair did not actually get so much worse physically, cognitively and socially after the triple live virus vaccine … like her parents dared claim.

During his video-related discussion, the French psychiatrist was constantly “supported” by Attorney Ricciardelli. After a while, they both seemed to have completely forgotten in their euphoria, that Michelle Cedillo’s case was not only about adverse events related to the MMR vaccination but also very much about the possible ill-effects from the large amounts of mercury that had been injected into her in the first year of her life.

The attorneys for the DOJ must have had their own reasons for bypassing all U.S. - trained and board-certified pediatric psychiatrists to choose a foreign expert who until recently had been swearing that autism was not increasing. They certainly seemed to have pushed “outsourcing” to a new dimension.

It is certainly regrettable that when it came to the foreign expert for the respondent, he was allowed to self board-certify when a well-trained American physician testifying for the plaintiffs was not even permitted to mention that she was board-eligible.

Double standards are always unfair. In a hearing about such devastating vaccine injuries, they are inexcusable.

As I see it, the biggest problem with “Cedillo v The Secretary of Health and Human Services” was the fact that it was the first “Test Case” about vaccines and autism. The attorneys for HHS needed to mount a colossal defense to assure that it was defeated and they did!

Under different circumstances and had a knowledgeable medical expert presented a pediatric system review of Michelle’s findings and how they could each be related to her vaccination (s), there would and should have been a reasonably good chance for a different decision.

The following facts are beyond denial:

1. Autism was not Michelle’s only injury
2. Michelle was healthy at her first birthday and she is not now
3. There is no pathological entity that can cause so many serious problems in so many systems at the same time

If so, then the question must be asked: If Michelle did not have a vaccine reaction, then what caused her many present serious problems?

Before the paid and biased pro-vaccine crowd starts attacking me personally, let me repeat that I am not on some anti-vaccination crusade and that I am pro-judicious vaccination. The CDC itself concedes that adverse events do occur following vaccination. If they did not, we would not need VAERS and the Vaccine Injury Compensation Program.

Michelle and her parents have been suffering a living hell. They deserved to be compensated. It is regrettable that in their case, “Justice” was not better served.


2. Busting Rules. How a questionable testimony affected so many cases

The Cedillo case was one of three test cases involving the vaccine-autism connection.

The verdict in Cedillo v Secretary of HHS was interpreted as absolute proof that vaccines never triggered autistic regression in children.

The fact that the petitioners did not prevail does not mean that Michelle Cedillo was not vaccine-injured. It only means that the Special Masters did not think that the evidence presented by them was as convincing as that presented by the DOJ.

The Special Masters’ conclusion, that the DOJ evidence was more convincing, stands however on shaky ground. It should become clear that the testimony by Stephen Bustin PhD, which seriously affected the decision, should have never been considered because it included extremely complicated yet unsupported scientific evidence that had not been made available to the petitioners as expected.

Furthermore, RNA test results performed in the same laboratory that was criticized by Dr. Bustin were later found to be perfectly concordant with those from laboratories at the CDC and at Columbia University.

Because of this new evidence discussed here for the first time, I respectfully submit that, more likely than not, Michelle Cedillo’s measles virus genomic RNA testing, done on a biopsy from her diseased gut, was both accurate and reliable. Because doubts about that specific testing so much affected the case and the Special Masters’ decision and because the test so strongly suggests a connection with Michelle’s MMR vaccination, I hereby request a review by the Department of Justice.

At the very least, the Cedillo decision should not be used to deny thousands of families their rights.

Measles is a notifiable disease in the United States. According to the Arizona Department of Health, there were no measles outbreaks in the state and only 44 cases of measles from January 1, 1994 to December 31, 2000. [ ]

The population of Arizona increased from 1,465.404 in 1990 to 5,130,632 in 2000. If one conservatively estimated the state’s average population at 3 million between 1994 and 2000, there was one case of measles per 68,000 Arizonians during the period in question. [ ]

According to the CDC, “measles is a highly contagious respiratory disease caused by a virus…Measles causes fever, runny nose, cough and a rash all over the body. About one out of 10 children with measles also gets an ear infection, and up to one out of 20 gets pneumonia. For every 1,000 children who get measles, one or two will die. [ ]

Babies are quite sick when they come down with measles. Michelle’s medical records neither mention a doctor’s visit for measles nor an Arizona DOH notification for the disease.

If Michelle Cedillo had evidence of measles virus Genomic RNA in her intestinal biopsies, then her GI findings were related to her MMR vaccination.

In his decision, Special Master Hastings discussed petitioners’ exhibit 130 (p. 70) and stated that according to Shiels, O’Leary et al, 12 of 12 gut biopsies from children with developmental disorders tested at the O’Leary laboratory “indicated the origin of the virus to be vaccine strain”. The Special Master went on to offer his own reasons why he rejected the Shiels information essentially insisting that the petitioners did not show conclusively that Michelle’s intestinal biopsy revealed vaccine-strain measles virus RNA.
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In response, I would respectfully submit the following: If indeed the petitioners had to present hard and absolute etched-in-stone evidence that Michelle’s biopsy revealed evidence of vaccine-strain measles virus to prevail, then why did the DOJ attorneys spend all this money, time and effort to prove that Michelle’s testing and the lab where it was performed were unreliable and why did we import Dr. Bustin?

Dr. John O’Leary is an uncontested expert with a stellar reputation and Special Master Hastings conceded that. To effectively torpedo the first autism test case, the attorneys for the respondent needed to produce extremely solid evidence that Michelle’s RNA results were wrong and that the laboratory where the test was performed was unreliable.

As I will show, they did not.

On April 14, 2010, I submitted FOIA requests to the CDC and DOJ asking for copies of all communications with British journalist Brian Deer starting in 1998.

On August 16, 2010 the CDC/ATSDR FOIA Officer informed me that a search of records failed to reveal any CDC documents pertaining to my request.

To date, the DOJ has not responded and I have no way to ascertain what exactly Mr. Deer gave the government attorneys in the spring of 2007. What is clear is that shortly thereafter Stephen A. Bustin PhD suddenly became an expert witness for the Respondent.

In an exchange of remarks in a British website almost two years later (February 13, 2009) Mr. Deer wrote: “…I recall supplying a key document on the O’Leary lab business, which the DOJ didn't seem to know about just weeks before the hearing. Hence the late surfacing of Bustin and Chadwick…”

The following day Deer added: “…They didn't use my material. Under the 1983 medical act, they acquired all their own material, key portions of which I had previously and separately acquired…”
It is important to keep in mind that Mr. Deer said that he supplied a document and not simply information about it, to DOJ.

Since he started writing about the “MMR scandal”, Deer seems to have repeatedly been given free access to confidential and secret material related to the subject. In an exchange in BMJ earlier this year, Mr. Deer revealed that he even knew the names of the 12 patients in Wakefield’s first study plus many details about them, information that was supposed to be kept confidential.

The fact that Mr. Deer actually obtained and transmitted highly classified material about the O’Leary laboratory, material that the HHS attorneys did not have and would later allegedly have trouble getting, besides being surprising, must have been a breach of some English law.

Unfortunately, no one seems to know, except those involved of course, who in 2004 actually gave Mr. Deer the secret document that he sent to DOJ just before the MMR-Autism “Test” case was to get underway. It could have been Merck who needed to sabotage it and it could have been Dr. Bustin who was frustrated by the gag order, as he declared in a later interview (below). Regardless, under no circumstances should Deer have been privy to this information and the fact that little attention was given to the whole matter is disturbing, though it seems par for the course.

The Timetable
1998: Dr. Wakefield publishes his well-known paper, later withdrawn, in Lancet. 1999-2000: Merck contacts several sources looking for some way to disqualify O’Leary’s findings
2000: Professor Stephen Bustin produces his “first” report criticizing O’Leary’s work and results for use in the U.K. MMR case, a legal action that was filed on behalf of some 1000 British children who reportedly developed autism after MMR vaccination.
2001: U.S. parents start filing petitions for compensation under VICP, alleging that their children had also developed autism following immunization with MMR and Thimerosal-containing vaccines.
2002: The Office of Special Masters concerned about the upcoming Tsunami, issues Autism General Order #1 establishing the procedure for addressing the Omnibus Autism Proceeding (OAP).
September 2003: A Sunday Times Section Editor takes Brian Deer to lunch and asks him to write “something big” about the MMR. That editor’s father, a renowned British physician, had served on the committee that considered the approval application of one of the MMR vaccines later licensed in the UK.
October 2003: Funding for the MMR litigation in the U.K. is cut
Early 2004: That decision is confirmed by Judge Nigel Davis and for all practical purposes most or all the MMR cases in the U.K. become a non-issue. The judge’s brother, Crispin Davis, was a board member of GlaxoSmithKline, a defendant in the case.
Many are jubilant but Merck, who manufactures the only U.S. licensed MMR vaccine, does not celebrate because it is well aware that the floodgates are ready to open in the United States.
Looking to the future, Merck succeeds in having the English Court ask the Irish Government to issue an order allowing Stephen Bustin PhD, an expert on PCR, to inspect the O’Leary laboratory in Ireland. The request is granted and Dr. Bustin starts working on his report clearly not for local consumption, but in preparation for the upcoming battle across the Atlantic.
2006: The Cedillo case is scheduled to start on Monday June 11, 2007.
It is customary for all experts invited to testify in cases involving scientific controversies to submit their reports early enough to give the other side the opportunity to see them and respond to them. The actual period of time differs from court to court and may differ from judge to judge but there certainly are numerous accounts of serious scientific evidence having been excluded in the past because it was not submitted before the deadline, usually weeks before the hearing.
Early 2007: Brian Deer contacts the DOJ and provides an important document related to the O’Leary lab. The information is valuable but it cannot be used because it came from the freelance journalist. The DOJ must therefore officially request it and obtain it through legal channels.
Friday, June 1, 2007: Michelle Cedillo’s parents get ready to go to Washington DC
Thursday, June 7: Attorneys for the DOJ request permission to file Dr. Bustin's report.
Friday, June 8: Attorney for the plaintiff objects and requests the report not be admitted. Her request is turned down. She then asks for more time to prepare and that request is also turned down.
Monday, June 11, 2007: The Cedillo hearing gets underway, with the understanding that Dr. Bustin will be allowed to testify but that the Special Masters will later decide whether to admit his testimony or not.
Wednesday, June 20, 2007: Dr. Bustin is called to the stand and is sworn in.

Dr. Bustin was allowed to present highly technical information even though the O’Leary Lab notebooks on which his information was based were still in England and unavailable for inspection. He was also allowed to quote extensively from a report by another expert even though that report was also under seal.

Regardless whether it was legal or even fair to consider Dr. Bustin’s testimony, was it in any way actually relevant to the Cedillo case?

The most Bustin claimed was that O’Leary’s laboratory was likely not to detect low levels of inflammation, so-called “low copy numbers”. He did not contest the accuracy of the lab results in cases with “high copy numbers” i.e. high levels of inflammation. Expert testimony confirmed that Michelle Cedillo had high copy numbers and Dr. Bustin himself conceded that she did.

I remember telling myself: So why did he come and what did his testimony exactly prove, as far as this case is concerned?

Another question also still haunts me is: How and why was Dr. Bustin, who received funding from Merck, allowed to testify in a case involving a Merck product? Why was that allowed?

Dr. Bustin testified that he had discovered one episode of contamination in the O’Leary Laboratory books he had reviewed, and that were not made available to the defense. He never mentioned that in spite of all precautions, some “contamination” does occur, from time to time, in the best research laboratories in the world.
In any case, it is a fact that even if the contamination in the Irish lab had been rampant, it could not have resulted in specific high levels of inflammation being found in a specimen.

So far, I have shown why Dr. Stephen Bustin should not have been allowed to testify in the Cedillo case and how his testimony did not prove that the testing done on Michelle’s gut specimens was wrong and unreliable.

Next I will show that even if Dr. Bustin’s testimony at the Cedillo hearing had been relevant and allowable, it should have been excluded anyway because of what he decided to do and say just after he returned to London.

It is important to point out again that Special Masters Denise K. Vowel, Patricia Campbell-Smith and Georges L. Hastings Jr. had decided that:
“For the purposes of the Omnibus Autism Proceedings (“OAP”) and for the reasons indicated in the ruling issued on June 8, 2007, in Cedillo v. Sec'y of HHS , the undersigned special masters will defer deciding whether we will rely on the reports of Dr. Bustin (Respondent's Exhibits WW and XX) as evidence in the OAP. However the parties may question Dr. Bustin or any other expert witness concerning the contents of these two reports at the proceedings commencing on June 11, 2007.”

On Wednesday July 4, 2007, well-known science writer Dr. Michael
Fitzpatrick published an article in London titled:
‘The MMR-autism theory? There’s nothing in it’ Michael Fitzpatrick talks to Stephen Bustin, whose devastating testimony in a US court demolished the last shred of evidence against vaccines.

He wrote:

“Testimony in a US court last week by London-based molecular biologist Stephen Bustin comprehensively exposed the unreliability of O'Leary's findings, based on an investigation of his laboratory carried out in early 2004. ‘It has been incredibly frustrating', Professor Bustin told me on his return from the USA. ‘For three years we have been unable [for legal reasons] to reveal our findings. Now I want to get the message out about the O'Leary/Wakefield research: there's nothing in it'.” [ ]

Dr. Fitzpatrick then revealed the real reason why all this needed to be advertised immediately: “…the testimony of Bustin and other expert witnesses was yet another blow for the anti-vaccine campaigners as Andrew Wakefield returns to London next week from his new base in a private clinic in Texas to face charges of professional misconduct at the General Medical Council.”

I am not aware of any other expert in the case discussing his testimony in public or granting interviews before the decision was announced. In fact, I do not know of any expert anywhere who would have considered granting such interview. For Dr. Bustin to do so, when he was well aware that all three Special Masters had yet to decide whether to consider his testimony or not was at the very least irresponsible.

In his decision filed February 12, 2009, Special Master Hastings discussed the issue of Dr. Bustin’s testimony at length, evidently realizing that it was certain to lead to an appeal. He stated that “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.”
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Special Master Hastings then explained that he had decided that the testing done in the O’Leary lab was unreliable based on evidence presented by experts other than Bustin but particularly for three other reasons: “(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.”

With all due respect, I would point out that:
(1) Research laboratories very rarely provide sequencing data and not because they have anything to hide. In addition, there is no evidence that the DOJ ever requested the sequencing data for Michelle’s test and did not receive them. It seems therefore at the very least unfair to allow Bustin to testify, without submitting supporting evidence, and then punish the Cedillos for not having presented supporting evidence they were never asked to provide.
(2) Other laboratories in England, Japan and the United States have certainly replicated the “testing” performed in Dr. O’Leary’s Laboratory in Ireland. John O’Leary was not the only researcher in the world testing for measles virus RNA in the last few years. A discussion of the O’Leary “testing results” follows.
(3) I read “No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells From Children With Autism Spectrum Disorder by Yasmin D’Souza, Eric Fombonne and Brian J. Ward. Pediatrics 2006;118;1664-1675”. It was totally about research done on blood. Specifically, D’Souza et al did not discuss Michelle Cedillo’s test results and did not question the fact that she had evidence of measles virus Genomic RNA in her gut.

The O’Leary test results

Dr. O’Leary’s test results were also replicated. In fact, experts for the Respondent had stated during the hearing that the laboratory of Dr. Oldstone in the U.S. and that of Dr. Cotter in the U.K. had indeed performed tests and found results similar to those from Dr. O’Leary’s Laboratory

In a footnote on page 116 of his decision, Special Master Hastings wrote:

154 Another epidemiologic study was published in September of 2008. Mady Hornig et al., Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case ControlStudy, 3 PloS ONE e3140 (2008), available at . Neither party has sought to make that study part of the record in this case, so I have not relied upon it. However, the abstract of that study states that the study “provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure.” Thus, it appears that the study would only add more weight to the conclusion that I have otherwise reached.
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As the Special Master pointed out, the mentioned study was published in September 2008 after the Cedillo hearing had ended but before the decision was announced (February 2009). It could not have been introduced in evidence by the petitioners during the hearing.

In my critique of the study in question, I explained why the authors’ findings were so different from Wakefield’s. [  ]

It is regrettable that Special Master Hastings did not notice that just two sentences above the quote he cited, the authors had stated in their abstract that: “Results were consistent across the three laboratory sites.”

He also did not apparently notice that the authors had further confirmed under Real-time RT-PCR assays that: “All laboratories correctly identified all positive controls … All laboratories correctly identified all negative controls.” [ ]

The study was sponsored by a CDC grant to the American Academy of Pediatrics (AAP) and by NIH individual grants. It was authored by renowned experts from Columbia University, Harvard University, the CDC and the American Academy of Pediatrics.

The three laboratory sites the authors used for testing for measles virus RNA were Coombe Women's Hospital, Trinity College, Ireland (Dr. O’Leary’s Lab); Center for Infection and Immunity, Columbia University, New York; Measles, Mumps, Rubella, and Herpesvirus Laboratory Branch, CDC, Atlanta.

If one accepts the facts that the authors including those from the CDC and AAP chose the O’Leary Laboratory to test their specimens and that the results of tests performed at the O’Leary Laboratory were identical to those from the Columbia University and CDC laboratories then one must conclude that the O’Leary Laboratory is reliable and that its results are accurate.

It is therefore safe to state that the testing performed on Michelle Cedillo’s specimen at the O’Leary Laboratory was also reliable and accurate. Because Michelle never had measles and because evidence of measles virus RNA was identified in her gut biopsy specimen, it is more likely than not that her gastro-intestinal findings were related to her MMR vaccination.

As very well expected, the Bustin testimony became part of the Appeal by plaintiffs.

The following exchange between Judges Newman, Linn and Dyk who reviewed the Cedillo case on Appeal and Attorney Lynn Ricciardella (LR) is very revealing. It shows how differently jurists in regular courts of law would have reacted to irregularities related to Dr. Bustin’s testimony.

There was no written version of the minutes and what follows was obtained with difficulty from the official sound recording. If there are minor discrepancies, they are certainly not intentional.

Beginning at mark 23:20

LR: My name is Lynn Ricciardella and I represent the Secretary of Health and Human Services. Your honor..
Judge Dyk: Is it the government’s position that you can put on an expert witness without putting on the underlying documents - seems to me troubling. If this were a proceeding governed by the federal rules of civil procedure rule 26, you'd have to produce the underlying documents and if you didn't the witness’ testimony would be excluded, is that correct?
LR: That is correct your honor.
Judge: Why should vaccine proceedings be different? I understand that the federal rules don't technically apply here but it seems to me a matter of fundamental fairness that if a witness is going to testify that the other side should get the underlying materials to enable them to cross examine.
LR: Your Honor. We don't even know if the underlying materials exist and we don't know that what's...........
24:14 Judge: Well that's your problem, you know. If they don't exist maybe the witness' testimony should be excluded too. But under the federal rules- you- it's your job if your gonna put on a witness to provide the materials that the witness relied on.
24:27 LR: With all due respect, we tried your Honor. We actually...our initial..ah...ah..when we first went to the United Kingdom we tried to get as much as we could. We tried to get the petitioners expert reports that were filed in the United Kingdom. We tried to get everything.
Judge Neuman: Was the petitioner and petitioners counsel present in the company of these various expeditions to try and get the evidence from England?
LR: In February of 2007 when the petitioners in the Cedillo case first filed their expert report, that's the first time the government became aware that results from Unigenetics were going to be vitally important in this litigation.
Judge Dyk: Was the petitioner notified that this was going on?
LR: We...we went to the United. No, we went to the United Kingdom on our own to try to get as much as we could. I mean we were in the process of putting our case together
Judge Newman: But this isn't an adversarial proceeding. The idea here is to find the truth, scientific facts, causation or what's known and to implement the policy of the statute. It's not a matter of surprise.
LR: This wasn't a surreptitious proceeding. With all due respect to Ms. Chin-Caplan
Judge Dyk: It may not have been surreptitious, but wasn't there an obligation?
LR: I...I don't. Respectfully your Honor, I don't believe so. I mean, we had to hustle to use a coloquial term. The..the..the trial was scheduled for June. We didn't know until the end of February 2007 that Unigentics was going to be vitally important to this litigation.
Judge: What did you do to get, to try to get the underlying data?
LR: We made an application. We first consulted with the solicitors in the United Kingdom because the United Kingdom is...has a special proceeding where these things are often sealed and it takes an actual act of court to unseal them. We went to the solicitors in the United Kingdom and said we...we want all these...all these reports. We didn't really know what was there...
Judge: Nah nah nah no forget reports. I didn't say reports. We're talking about the underlying data. What did you do to get the underlying data?
LR: We..we went to the..we went to the solicitor and said we would like everything that we could possibly get our hands on that pertains to Unigenetics underlying data. All the reports both reports that were filed on behalf of the plaintiffs in the United Kingdom and reports that were on behalf of the manufacturers. Our solicitors after putting the package together said 'you know, your application is going to be denied. It's too broad. You need to hone in on what you really want because this...this was a case --- of first impression --- in the United Kingdom. This had never been done before. It was a rule of law that had just been created.
Judge: Did you do that?
LR: And our solicitors said...yes...we honed it down to the three that we were able to get.
Judge: Three what?
LR: The three reports.
Judge: What about the underlying data? Did you ask for the underlying data?
LR: I...I don't believe so, but then we were under counsel from our solicitors.
Judge: I don't understand not asking for the underlying data? You knew you were going to put in Bustin's testimony. Why didn't you ask for the underlying data from the UK courts? That would seem to be fundamental. What more important than the other expert reports that were put in …

The discussion clearly shows that the Appeal Court Judges viewed the failure by DOJ to produce and share all data as a fundamental error that was unfair to the plaintiff, something that would have never be allowed in ordinary court, and therefore should have not been allowed in this case.

The statement by Attorney Ricciardella that “In February of 2007 when the petitioners in the Cedillo case first filed their expert report, that's the first time the government became aware that results from Unigenetics were going to be vitally important in this litigation” supports my earlier argument. The DOJ attorneys themselves considered the identification of measles virus genomic RNA in Michelle’s gut biopsy to be evidence that her gastrointestinal pathology was related to the MMR vaccine she had received.

Presiding in his Court in London on June 6, 2007, Judge Keith gave the DOJ attorneys all the sealed English documents they wanted.

In his judgment Judge Keith stated:

“13. Although the Secretary for Health originally wanted to obtain from the records of the court copies of a wide-ranging number of documents, the only documents which are now sought are the two reports of Professor Bustin and the reports of Professor Rima and Professor Simmonds.”

It is evident that a) Judge Keith was aware that the DOJ attorneys had originally wanted many more documents and b) he released to them everything they asked for in their official request.

Attorneys, including those at the DOJ, are not shy when it comes to requesting records they need. If Ms. Ricciardella really wanted to get “everything” she should have requested everything and there is a very good chance that she would have received everything from Judge Keith.

The fact is all data related to the O’Leary reports were never requested and one must ask why.

For the evidence by Dr. Bustin to be reliable, it had to be complete and as long as the supporting evidence and the laboratory books were not available, the evidence was not complete. It was therefore not reliable and it should not have been allowed in the first place.

Did Bustin’s so-called “devastating testimony” really demolish the last shred of evidence against vaccines, as Fitzpatrick claimed after the London interview? Certainly not!

Did Bustin’s testimony affect the outcome of Cedillo v The Secretary of HHS? Apparently yes, because Special Master Hastings ultimately decided that: “… there is no valid reason for me to disregard the evidence supplied by Dr. Bustin”.

The tragedy of it all is that Michelle Cedillo’s RNA testing was more likely than not accurate and that the O’Leary Laboratory results were indeed reliable. The fact that Michelle had evidence of measles virus RNA in her gut biopsy strongly suggests that her severe gastrointestinal findings and symptoms were related to her MMR vaccination.

The defeat of the Cedillo case, the first “Autism” test case, not only prevented a poor vaccine-injured child from receiving her rightful compensation, but it also compromised the rights of many other children.

All this Injustice needs to be rectified. At the very least, the decision in Cedillo v The Secretary of HHS should not be used to deny thousands of families their rights.

3. Translation in the Court

As discussed earlier, Eric Fombonne MD and Stephen A. Bustin PhD were effective expert witnesses for the respondent in the Cedillo case [Theresa Cedillo and Michael Cedillo, as parents and natural guardians of Michelle Cedillo v. Secretary of Health and Human Services - No. 98-916V].

While Dr. Bustin criticized the laboratory testing and results, Dr. Fombonne directly influenced the plaintiff’s case by discussing the vaccine-injured girl herself.

He may have been the respondent’s MVP. 

Dr. Fombonne first testified in Washington DC on June 18, 2007 (Day 6).
[ ]

DOJ Attorney Lynn Ricciardella started questioning Dr. Fombonne about his education and credentials (p. 1241) by asking:
Q. Doctor, you received a Baccalaureate in science with distinction from the Academy of Paris
A. Yes. In 1971. Yes
Special Master Hastings: Dr. Fombonne, can we ask you to do the best you can to speak up a little louder so the folks can hear you?
The witness: Yes I know. I know.
Ms. Ricciardella: He has a soft voice.
Special Master Hastings: You have a nice, soft voice.
The witness: No, No.
Special Master Hastings: You just need to speak up as best you can.
The witness: I know it is a problem.
Special Master Hastings: And maybe perhaps going a bit slower would make it easier to understand as well.
The witness: Okay. Okay.

The record does show that Ms. Ricciardella asked and the witness confirmed that he received a “Baccalaureate in science with distinction” in 1971. 

It is reasonable to suggest that most people who heard the exchange understood that in 1971, the witness obtained the French equivalent of a Bachelor of Science degree, a BSc degree in science, with flying colors.

In his 59 page CV updated January 21, 2007, Dr.  Fombonne listed the following under Education and Training:

1971: Baccalauréat C (Sciences), Mention Bien (Académie de Paris)

It is not clear why Attorney Ricciardella decided to call the degree a “Baccalaureate in Sciences” instead of simply reading what was listed on the expert’s CV.   

While it might have seemed that the witness obtained the French equivalent of a BSc degree in science with flying colors, the fact is, the nomenclature is different. The term “Baccalaureat” or “Bac” is used in France to describe the examinations and diploma at the end of the last year of high school. It is a requirement to enter university and it is not unusual for French doctors to list their “Baccalaureat” with their medical education. The reference to “Sciences” now shortened to S, simply means that during the last year of “lycee” or high school, the graduate took advanced science courses instead of other focused subjects.

In France, the term “Baccalaureate” is rarely used instead of “Baccalaureat” in schools with a large number of foreign students. To confuse things even more, in Belgium and Canada, “Baccalaureat” is used interchangeably with “Bachelor Degree” at the university level. 

In the USA, where the Cedillo hearings were held, a “baccalaureate” is only defined as the degree of bachelor conferred by universities and colleges.
[ ]

French students will usually finish pre-school by age 6, elementary school by age 11, middle school by age 15 and high school by age 18. 
[ ]

Dr. Fombonne was 17 years old in 1971
[ ]

The French “Baccalaureat” that he obtained that year was not a university degree and it was not equivalent to a Bachelor of Science degree (BSc) that requires four years of hard work in any university in Washington DC or the 50 states. 

Grading in the French educational system is different from ours. The “pass mark” is 10 out of 20 and it is unlikely for a high school student to score a perfect 20. French school exams including the “Bac” are usually very difficult and are consistently more rigidly graded than ours. A “mention assez bien” (translated “almost good”) is probably equivalent to “Honors” in our system and is awarded for a mark between 12 and 13.99. A mark between 14 and 15.99 will earn a “mention bien” (good) that is equivalent to “High Honors” over here and a mark of 16 or higher will merit a “mention très bien”, translated “very good”, but in fact comparable to our “Highest Honors”. The term “Distinction” is not used as a grade in any French exam including the “Baccalaureat” but a French student may feel that it is a “distinction” to obtain a “Mention Bien”.

Now three years later, I am at a loss to know why the attorney for the respondent thought it was necessary to inform three Special Masters, a court full of people and all of us listening by phone that her expert witness, a university Professor, had graduated from high school with a grade between 14 and 15.99 out of 20.

Attorney Ricciardella then asked the witness about his medical education at the University of Paris (p. 1241) and he answered “Right. I went to medical school from 1971 to 1978”.  Special Master Vowell then interrupted to tell the witness that he was talking into the court reporter microphone and that he should also be talking into the flat microphone that was transmitting to the whole room.

The witness agreed and Ms. Ricciardella jested “We’re high tech here”.

She then asked again: “So you have a medical degree, Doctor, is that correct? And the witness answered: “Yes, that is correct.”

Q. And you have a Master’s certificate in Biostatistics Methods in Human Physiology, is that correct?

A. Yes

Q. Following medical school, where did you do your residency?

A. I did my residency in psychiatry at the University of Paris from 1977 to 1982, I think. Yes.

The witness had stated that he “went to medical school from 1971 to 1978” and the question was about a residency “following medical school.” Ms. Ricciardella did not ask and the expert did not explain why psychiatric training in 1977 and 1978 prior to graduation was included with training “following medical school”.   

On page 6 of his CV, the expert listed his psychiatric training in Paris as follows:

1977/10-1978/09: Intern in the Department of Adult Psychiatry of CHU Cochin-Port-Royal, Paris 14.
1978/10-1979/03: Intern Adult Psychiatry Department, Service Dr. Bertrand, Hôpital Ste-Anne, Paris
1979/04-1979/09: Intern Adult Psychiatry Department, Service Dr. Segal, Centre Hospitalier Spécialisé Les Murets, La Queue-en-Brie (94).
1979/10-1980/09: Intern Child Psychiatry Department, Service Dr. Jeanneau, Centre Hospitalier Spécialisé Charcot, St Cyr l'Ecole (78).
1980/10-1981/03: Intern Adult Psychiatry Department, Service Pr. Martin, Hôpital L'Eau Vive, `Soizy-sur-Seine (91).

No one is questioning Dr. Fombonne’s training in psychiatry but it is clear from his CV that it consisted of “internships” between October 1977 and March 1981.

Ms. Ricciardella should have referred to them as such and then asked Dr. Fombonne to elaborate and explain how in France, a year of internship may indeed be equivalent to a year of residency in the United States, which is true. She should not have referred to his residency in psychiatry at the University of Paris because, as per his own listing, the word “residency” is not mentioned in his Paris training.  

Finally, according to page 2 of his CV, the witness was serving in the French Army in Guadeloupe, West Indies from April 1981 to March 1982. He was not a resident in psychiatry at the University of Paris. He was 4,000 miles away.  

Now we get to the question posed by Ms.  Ricciardella: “And you have a Master’s certificate in Biostatistics Methods in Human Physiology, is that correct?” to which the witness answered: “Yes, it is correct”. 

On page 1 of the same CV, this particular achievement is listed as follows:

1976-1977 Master Degree ½ Certificate in Biostatistic Methods (Professor D. Schwartz, U.E.R. Kremlin-Bicêtre, Paris XI, Mention Bien)

 1976-1977 Master Degree ½ Certificate in Human Physiology (Professor Bargeton, U.E.R. René Descartes, Paris V).

It is not clear why Attorney Ricciardella added the half certificate in Biostatistics Methods from the Eleventh arrondissement to the half certificate in Human Physiology in the Fifth arrondissement to make a whole “Master’s certificate in Biostatistics Methods in Human Physiology” when the word physiology is not mentioned in the first degree and the word biostatistics is absent from the second.

For those who may be interested, a Paris arrondissement is a city district or a neighborhood. To go from the lovely 5th on the Rive Gauche to the 11th, one must cross the Seine and …the fourth arrondissement.

In 1976-1977, Dr. Fombonne was in his fourth cycle in medical school, the DCEM4, a grueling mix of academic and clinical training at the University of Paris.

It would be safe to say that most physicians and medical students would be in awe learning that during that very busy and crucial period, any human could do much more than fulfill the requirements of the program let alone get a “Master’s Degree in Biostatistics” as we know it and … start his psychiatric training.   

The “Certificat de Phisiologie”, a Physiology Certificate, from the University of Paris V that Dr. Fombonne indeed obtained in 1977 indicates that he satisfactorily completed an approved course in physiology.

In the United States, a Master Degree in Biostatistics from a university is usually awarded to students with a Bachelor Degree who satisfactorily complete 32 credit hours of work and study. [ ]

There is no available information concerning the specific ½ certificate in “Biostatistics Methods” that Dr. Fombonne obtained.

A course in “Methodologie statistique” presently given in Paris started October 5, 2010 and will end January 28, 2011 with a break for Christmas from December 18, 2010 to January 3, 2011. The course consists of a weekly formal lecture of 90 minutes in addition to 2 hours a week of “Travaux Dirigés”, essentially a period of practice and statistical exercises.
[ ]

On June 25, 2007 his second day on the stand, the witness’ testified mostly about epidemiology and biostatistics.
[ ]

He discussed several epidemiological studies including two of his own, one from the U.K. and one from Canada. The reports of both studies were published in PEDIATRICS in 2001 and 2006 respectively.

In “No Evidence for A New Variant of Measles-Mumps-Rubella-Induced Autism” [Pediatrics 2001;108;e58] Fombonne and Chakrabarti reported that:
“No evidence was found to support a distinct syndrome of MMR-induced autism or of “autistic enterocolitis.”

Discussing that particular study in their highly esteemed evidence-based Cochrane MMR Review, Demichelli, Jefferson et al opined that “The numbers and possible impact of biases in this study is so high that interpretation of the results is impossible.” [Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD004407. Review]

In “Pervasive developmental disorders in Montreal , Quebec , Canada : prevalence and links with immunizations” Fombonne et al (Pediatrics. 2006 Jul;118(1):e139-50) concluded that: “…The findings ruled out an association between pervasive developmental disorder and either high levels of ethylmercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measles-mumps-rubella vaccinations.” 

It is likely that many at the hearing were impressed by the witness’ knowledgeable presentation and the dazzling statistics that he quoted with great ease and clarity. It is also likely that no one realized that in this study, which only included 180 children from one English school district in Montreal and centered on their PDD diagnosis and vaccination history, not one of the five authors ever reviewed a single chart in order to at least confirm the diagnosis. According to the authors “Children with a diagnosis of PDD were identified by school personnel and given a study code to preserve the anonymity of the data. Children’s diagnoses were not verified by direct assessments …”

In a letter to the editor of PEDIATRICS, David Ayoub MD objected to the data and conclusions related to the Thimerosal in vaccines in the school district the authors investigated. In a letter I sent to the editor, I took issue with the authors’ claim that in that same school district, “pervasive developmental disorder rates significantly increased when measles-mumps-rubella vaccination uptake rates significantly decreased.”

Quoting three official Montreal incidence studies, I showed conclusively that the MMR vaccination rates in Montreal had actually increased during the study period along with the cases of ASD. The authors had used MMR vaccination rates from Quebec City and its surrounding, 160 miles away from Montreal. [ ]

Dr. Fombonne refused to answer our letters and the editor never published them.  

Listening by phone to the testimony in the Cedillo case, I wondered how many at the hearing knew that in 2001, Dr. Fombonne had questioned the very existence of an epidemic of autism spectrum disorders.

In “Is There an Epidemic of Autism?” also published in PEDIATRICS, the expert had asserted: “… To date, the epidemiologic evidence for a secular increase in the incidence of PDDs is both meager and negative… [PEDIATRICS Vol. 107 No. 2 February 2001, pp. 411-412]

According to a CDC study, 6.7 out of 1,000 eight year old U. S. children were on the autism spectrum in 2000, when Dr. Fombonne was writing his paper.[ ]

The Merriam-Webster Dictionary defines an epidemic as an excessively prevalent condition. Many would agree that a prevalence of 1 in 149 is excessive.  

After listening to days of testimony from both sides in the Cedillo case, the Special Masters decided that the respondent’s experts were more believable and that their testimony was more convincing.  

I certainly respect the Special Masters’ right to their opinion but after listening to many experts from both sides and reading several transcripts, I must respectfully disagree with their final decision.

In the previous pages, I reviewed some of the testimony of the likely leading expert for the respondent. There is every indication that the special treatment he received influenced the hearing and its outcome.

In any case and as I keep repeating, the Special Masters’ decision does not mean that Michelle Cedillo was not vaccine-injured.

Her parents, who have been with her all along and who have witnessed and documented what happened to her, are sure that she was.

I believe them and I agree with them.

F. Edward Yazbak, MD, FAAP
Falmouth, Massachusetts