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Busting Rules by F. Edward Yazbak, MD, FAAP (Part 2 of 3)


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.
[http://www.azdhs.gov/phs/immun/conf/materials/workshops/VaccinePreventableDiseasesinArizona.pdf]

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. [http://www.npg.org/states/az.htm]

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. [http://www.cdc.gov/measles/index.html]

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.
[http://www.uscfc.uscourts.gov/sites/default/files/vaccine_files/Hastings-Cedillo.pdf]

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'.” [http://www.spiked-online.com/index.php?/site/article/3562/]

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.”
[ftp://autism.uscfc.uscourts.gov/autism/vaccine/Hastings-Cedillo.pdf]

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:

154Another 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 www.plosone.org. 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.
[http://www.uscfc.uscourts.gov/sites/default/files/vaccine_files/Hastings-Cedillo.pdf]

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. [www.jabs.org.uk/pages/yazbak%20on%20cdc%20study.pdf]

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.” [http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140]

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: Noo..no. 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.


F. Edward Yazbak MD, FAAP
Falmouth, Massachusetts