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IMPORTANT NOTICE:

Starting in July 2018, Vaccination News will no longer be manually updating the news because I can no longer afford to do it and I get almost no financial help.  I have tried numerous solutions, including charging $10/yr but even that was too much for but a few people.

To see what the news will look like, scroll down the page to the RSS feed articles.

I welcome the opportunity to continue as before by receiving the necessary funding, so am giving everyone enough of heads up to possibly come up with it.  Costs, including legal and technical fees, are about $20,000/year, most of which I have been covering for many years.

All the best,

Sandy Gottstein

President, Vaccination News, A Non-Profit Corporation

HOW MORE THAN 5000 CHILDREN WERE HURT …AGAIN

HOW MORE THAN 5000 CHILDREN WERE HURT …AGAIN

F. Edward Yazbak M.D.

 

  • The selection of only THREE out of over 5,000 vaccine injury compensation cases to prove or rule out causality seems irrational. Yet this is exactly what happened in the Farce called the US Omnibus Autism Proceeding (OAP).
  • The case of Michelle Cedillo was filed in 1998 and scheduled to be “the first of three test cases” to be heard in the Vaccine Court in early June 2007.
  • The outcome of the case was unquestionably crucial to the OAP and the whole Vaccine Injury Compensation Program (VICP).
  • Attorneys for the Petitioner were prepared to present evidence that Thimerosal, a mercury compound in the pediatric vaccines administered to Michelle during the first year of life and the MMR vaccination that she received shortly after that, had contributed to her autistic regression and her many other health issues.
  • The assigned Department of Justice (DOJ) attorneys had lined up several experts to counter the petitioner’s Thimerosal allegations but … three months before the case was to be heard, they had not found anyone able to question the reliability of the special test that implicated the MMR vaccination that Michelle received.
  • For Michelle who never had measles, the result of her Real Time (RT) PCR Test appeared to be prima facie evidence that her MMR vaccination was etiologically related to her gastro-intestinal findings and her documented autistic regression.
  • To prevail, the DOJ Attorneys had to find fault with the test and the laboratory where it was performed, in order to avoid a flood of MMR vaccine related autism cases. 
  • I will present evidence that a free-lance British reporter inserted himself into the case and later boasted that he had recommended a British scientist who had inspected the Laboratory of Dr. John O’Leary where Michelle’s test had been performed and who had testified about his inspection in a British Court.
  • A “real” US Court hearing the Cedillo case would have rejected that expert who surfaced too late, had been paid obscene fees by manufacturers of the MMR vaccine, and had no supporting documents of his inspection because they were all sealed in London.
  • Furthermore, that expert was repeatedly seen talking with the reporter while the hearings were going on. He also discussed the case and his testimony in an interview as soon as he returned to London.   
  • Even though the issues that this British Expert brought up were not relevant to the case, his testimony seemed enough to influence the Special Masters who decided that Michelle’s GI findings were not MMR related, when indeed they were.
  • In their decision, the Special Masters mentioned that they were aware of a CDC-sponsored, AAP-funded US study that demonstrated that the results of RT CPR testing performed at a Harvard University Laboratory, a CDC Laboratory and Dr. O’Leary’s Laboratory “were consistent across the three laboratory sites”, namely that each of the three laboratories accurately identified every positive or negative result.

*****

April has been for sometime our National Autism Awareness Month.

This year, the CDC decided to set the week of April 16-23, 2016 as the National Infant Immunization Week to coincide with the “World Immunization Week”.

In the United States, the number of recommended vaccines increased steadily since the 1960s as did related adverse events (AEs) and their costly litigations. Awards for vaccine injuries became so frequent by the 1980’s that vaccine manufacturers reportedly threatened to get out of the vaccine market. Terrified and anxious to remedy the situation and to ensure the supply of present and future vaccines, the health authorities and pro-vaccine lobby convinced the US Congress to introduce the National Childhood Vaccine Injury Act of 1986 (Act), thus creating the National Vaccine Injury Compensation Program (VICP).

The VICP was to provide financial compensation to individuals injured by a VICP-covered vaccine or to their families in case of minors. Compensation for a death resulting from vaccination was capped at $ 250,000. [MMR manufacturer Merck also marketed Vioxx, an arthritis medication. A few years ago, a Texas Jury found Merck liable for a Vioxx death and awarded the widow of the deceased $24 million for mental anguish and economic losses. The jury also awarded her an additional $229 million in punitive damages. Because Texas Law capped punitive damages, it was expected that the widow would only receive around $26.1 million. http://tinyurl.com/j4z3te6 ]

The vaccine injury table was introduced with the Act in 1986. It lists the vaccine adverse events that are automatically compensated if they occur within a certain period of time after vaccination. Chronic arthritis is a known complication of rubella (German measles) and rubella vaccination. Chronic arthritis within 42 days of MMR vaccination is a “Table Injury”. Michelle Cedillo reportedly started limping soon after her MMR vaccination and later went on to have terrible discomfort and disability related to chronic arthritis that still needs treatment. Why this specific “table” disability was not deemed compensable is another unfortunate twist in the case. 

Once approved, the Act effectively shielded and protected the vaccine industry and the physicians or other licensed professionals who administered vaccines.

As a pediatrician, I have testified as an expert witness in hearings related to Vaccine Injury and Pediatric Disabilities.  This report will focus on Michelle Cedillo’s case and how she was deprived of well-deserved compensation for a vaccine injury. 

For a comprehensive legal review of the case, please see:

BRIEF OF AMICI CURIAE ELIZABETH BIRT CENTER FOR AUTISM LAW AND ADVOCACY, et al. IN SUPPORT OF APPELLANTS AND IN FAVOR OF REVERSAL by Mary Holland JD  http://tinyurl.com/gwsusgn

*****

 

The National Vaccine Injury Compensation Program

On Friday April 15, 2016, the opening statement on the National Vaccine Injury Compensation Program website was:

“Vaccines save lives by preventing disease.

Most people who get vaccines have no serious problems. Vaccines, like any medicines, can cause side effects, but most are very rare and very mild. Some health problems that follow vaccinations are not caused by vaccines.

In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction. In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.”

http://www.hrsa.gov/vaccinecompensation/

The wording of the above is certainly peculiar to say the least.

Since its inception in 1988, over 16,794 petitions have been filed, 14,441 petitions have been adjudicated and only 4,526 have been determined to be compensable.

There were 2,146 compensated cases in all from 1/1/ 2006 to 12/31/2014.

They included: DTaP vaccine 121 cases, Hepatitis B vaccine 61 cases, HPV vaccine 91 cases, Influenza vaccine 1,296 cases, MMR vaccine 94 cases and Tdap vaccine (adult) 156 cases. http://www.hrsa.gov/vaccinecompensation/data/statisticsreport.pdf

 

The MMR vaccine and the Omnibus Autism Proceeding

According to a May 2011 report in PEDIATRICS titled The National Vaccine Injury Compensation Program”: “There are 3 means to qualify for compensation: (1) a petitioner must show that an injury found on the vaccine injury table occurred in the prescribed time interval; (2) prove that the vaccine caused the condition; or (3) prove that the vaccine significantly aggravated a preexisting condition. The table  which lists specific injuries or conditions and the time frames of onset after a vaccine is administered, allows a legal “presumption of causation.” If a petitioner cannot establish a table injury, or no table injuries are listed for a particular vaccine, a petitioner has the option of proving causation. Beginning in 2001, petitioners began filing claims under the VICP alleging autism (or autism spectrum disorder) from MMR vaccine, thimerosal-containing vaccines, or both.4 In 2002, the Chief Special Master of the Court created the Omnibus Autism Proceeding to adjudicate the thousands of claims expected. As of January 2011, more than 5600 autism cases have been filed.5 Of these 5600 cases, more than 4800 cases are pending, and more than 800 claims have been dismissed at the request of petitioners or dismissed by the court because they were filed outside the VICP statute of limitations for injury claims. Some families have gone on to the tort system to pursue legal remedies. Several hundred suits alleging vaccine-related autism were pending adjudication at the beginning of 2010.

Entitlement hearings on general causation and 3 test cases for each theory under consideration were held in 2007 and 2008. In February 2009, 3 special masters ruled in favor of the HHS on the first theory (a combined theory that both MMR vaccines and thimerosal-containing vaccines cause autism or autism spectrum disorder). Appeals in each case were made to judges of the CFC, who all ruled in favor of the HHS. Appeals in two of the three cases to US Court of Appeals for the Federal Circuit also resulted in decisions in favor of HHS. http://pediatrics.aappublications.org/content/127/Supplement_1/S74

Of the three original test cases, the case of Michelle Cedillo was heard first.

The case, filed on 12/09/98 was heard by three Special Masters starting June 11, 2007. The Decision was published on February 12, 2009 and the Appellate Decision on August 27, 2010. During those long twelve years and to this day, the health of the beautiful child who was totally normal in the first year of her life has been deteriorating steadily and the lives of her wonderful parents and grandparents have been effectively devastated.

Very well documented before and at the “Hearing” were the following:

·         Michelle had a normal first year of life

·         She had received all the pediatric Thimerosal-containing vaccines usually administered during the first year of life

·         She had also received her recommended Varicella and MMR live-virus vaccines

·         Following her MMR vaccination, Michelle developed a multitude of neurological, intellectual, social, ophthalmic, gastrointestinal and arthritic complications, all well-documented by specialists

·         Michelle had clear and certified RT-PCR evidence of measles virus genomic RNA in her ileal biopsy, a clear indication of a direct association between measles virus and her gastrointestinal findings

·         That very reliable and accurate testing had been performed by Dr. John O’Leary, a reputable scientist, in his superbly equipped Unigenetics Laboratory in Ireland 

·         There was also reliable evidence that the detected measles virus RNA was actually from a “vaccine type” measles virus

·         Michelle had never had measles

 

*****

Legal Documents:

Special Masters Decision, No. 98-916V (February 12, 2009):

http://www.autism-watch.org/omnibus/cedillo.pdf

Appeal Court Decision: http://www.uscfc.uscourts.gov/sites/default/files/cedillo.fedcir.pdf

Case recordings: http://www.uscfc.uscourts.gov/cedillo-v-secretary-health-and-human-services-case-no-98916v-concluded-june-26-2007

 

BRIEF OF AMICI CURIAE ELIZABETH BIRT CENTER FOR AUTISM LAW AND ADVOCACY, et al. IN SUPPORT OF APPELLANTS AND IN FAVOR OF REVERSAL

http://tinyurl.com/gwsusgn

*****

2007: Limited Chronology of Events  

As stated earlier, the Cedillo case was filed in December 1998 and all her subsequent evidential reports were introduced as they became available.

Respondent’s experts hired to rebut complicated scientific issues normally submit their reports early enough to allow the Plaintiffs’ attorneys to examine them, have their experts examine them too and give those experts enough time to submit their own detailed responses.

The actual period of time differs from court to court and even from judge to judge but there certainly have been situations where scientific evidence not presented early enough, was summarily excluded.

It appears that Michelle’s biopsy findings and Dr. John O’Leary’s interpretation of those findings were introduced in evidence in February 2007.

According to British Freelance Journalist Brian Deer, DOH attorneys did not know that there were British experts who had actually inspected the Laboratory of Dr. O’Leary at the request of the British Government.

[Quote - Mr. Deer: … I’m proud of my work investigating Wakefield. Unlike Kirby, I am not a campaigner, have never advocated any pharmaceutical product, and have never made statements on whether or not any vaccine may or may not cause any medical condition. If there are any editorial changes in any of my published work to that effect, I don’t know of them. I’m a reporter, and have simply sought out the facts on Wakefield’s research.

That said, I’m also very proud that, like the GMC, the US government sought my help in mounting of its case in Cedillo, copiously borrowing pages of evidence from my website and displaying some in court. I was surprised by this. I assumed that they would have sophisticated contacts with other governments and with industry, and could pretty much get what they wanted. However, on a number of occasions I would come home, find an email from the department of justice asking me for a document, and see that the next day it was being run in court. Bit of a seat of the pants job by the DoJ (brought about by the plaintiffs changing their case at the last minute). Indeed, 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. It was me wot done that, and I’m glad.

I don’t say these things to boast, only perhaps to wonder why – if there are all kinds of grand conspiracies behind the defence of vaccine safety – governments and regulators are so untogether that a mere journalist can get ahead of them in the game.

I think, for example, the British department of health should simply seize the medical records of the Lancet children, analyse them and pass the matter to the director of public prosecutions. All this GMC stuff, allowing doctors to investigate themselves, is a huge waste of dosh, although I say so myself. I gave them my materials, as was my public duty, but IMO the GMC’s lawyers should have said “this is not for us”, and brought in the DoH and the police. End of quote]

http://leftbrainrightbrain.co.uk/2009/02/10/wakefield/comment-page-1/#comments]

***

On April 14, 2010, I submitted a Freedom of Information Act Request to the US DOJ concerning any and all communications between Mr. Deer and the Department of Justice.

On November 3, 2010 the Attorney in Charge informed me that my request had been referred to the Civil Division’s Torts Branch, Vaccine Injury Compensation Program Section and that after a thorough search, that office had identified 15 pages of responsive e-mail communications. Eleven (11) pages were not exempt from disclosure and were provided to me. The remaining four pages were withheld “to protect the personal privacy of an individual.”

The first provided e-mail from Brian Deer to a DOH correspondent was sent Tuesday, January 9, 2007- 4:52 PM. It contained a copy of a long communication by him to a doctor who had co-authored an important article with Dr. Andrew Wakefield. For multiple reasons, I cannot comment on the long three and a half page e-mail that ended by the following somewhat strange invitation by Mr. Deer: “It may well be that, recognizing the public interest, both over the safety of children by means of vaccination, and over the integrity of research publication processes, you will candidly offer me your help. I’d respectfully suggest that this would be to your professional and personal credit. However, I can't hold your feet to the fire. I’m duty-bound to raise this material with you, and to seek your comments. I hope that you’ll see the sense of responding in an appropriate way.”

A second e-mail from Mr. Deer dated April 3, 2007 -11:44 AM (just two months before the start of the Cedillo hearing) contained advice to the DOJ on how to obtain dispatches from a TV Channel in London. After directing the DOH representative to the Wakefield information on his website, Mr. Deer added: “I also have a long letter I sent to the UK’s General Medical Council recently, explaining how Wakefield rigged his original research paper in The Lancet. You can have it if you want, but I am not sure you can evidence anything without access to the children's records. Pursuant to court orders, I‘ve read these records, and the GMC have copies. But I’m not sure how this helps you.

Observing your Omnibus action from the sidelines, as I do, it seems somewhat odd to me that vast quantities of US government and industry documents are being handed over to the plaintiffs, when similar disclosure doesn't seem to be sought from their side. But maybe I’m missing something.

Possibly, with regard to the Lancet case series, University College, London, might conceivably hand them over to you without too much fuss. But I realize that time is getting on at your end.” [End of quote]

A third e-mail dated April 11, 2007 -12:51 PM started by: “You’ve requested to see my letter of February 2007 to the UK General Medical Council concerning the conduct of Dr. Andrew Wakefield. I understand that the purpose of your request is to assist in preparations for a case before the federal special masters, concerned, among other things, with whether the MMR vaccine can cause developmental disorders. …”

Mr. Deer went on: “The safety of children by means of vaccination is plainly a matter of the greatest public concern. There can be no doubt that the US Department of Justice, presenting its case before the Special Masters, is a party with an interest in the questions raised in my letter. Moreover, I believe that this succinctly explains how Dr. Wakefield obtained the results he published in the Lancet in February 28, 1998. These are complex matters, and it may be that my rather prolonged study is of some small assistance…”

In the next e-mail, less than an hour later (4/11/2007: 1:46PM), Mr. Deer after discussing another issue and still believing that Dr. Andrew Wakefield will be testifying at the Cedillo Hearing stated: “Personally, if I was examining Wakefield, I would simply run him through four of his publications…”

In an e-mail on April 12, 2007 -3:32 PM, Mr. Deer wrote:” I am trying to send you a witness statement that was read in the Court in the MMR/MR litigation, and is therefore an open document. … On the other thing, you probably need to call me.”

The above exchange suggests that Mr. Deer started discussing the importance to call Stephen A. Bustin PhD around mid-April 2007. At the time, Dr. Bustin was Professor of Molecular Science, Institute of Cell and Molecular Science, Barts and the London, University of London and Visiting Professor of Molecular Biology School of Health and Social Sciences, Middlesex University.

*****

On Thursday, June 7, 2007, four days before the Cedillo hearing was to start, Attorneys for DOJ requested permission to file Dr. Bustin's report.

On June 8, the Cedillos and their attorneys were first informed by the Special Masters that Dr. Bustin had been discovered, that he had filed a report but that supporting documents records from the British Court had not been secured. Plaintiff attorney objected and was turned down. She then asked for more time to prepare and was again turned down.

On Monday, June 11, 2007: The Cedillo hearing got underway and Special Masters Vowel, Campbell-Smith and Hastings issued their official order on the Bustin matter: “For the purposes of the Omnibus Autism Proceeding (“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 in the proceedings commencing on June 11, 2007.

We need not decide the issue of consideration of the reports of Drs. Simmons and Rima in the United Kingdom case of Savers et al. vs Smith Kline Beecham Plc and others for June 11, 2007. Respondent orally indicated after the recorded status conference on June 8, 2007, that it will not ask to consider these reports as evidence at this time. We will revisit this issue, should respondents seek future consideration of these reports in the OAP.

In their recorded status conference held on June 8, 2007, the PSC, as well as counsel for Michelle Cedillo, raised the issue of access to all of the reports filed in Sayers. Should the PSC file for release of these expert reports, we will favorably consider joining in a quest for release of relevant reports.” [End of quote]   

The above order and its resulting legal ramifications at the very onset of the FIRST of 5,000 + very important vaccine injury compensation cases were of course at the very least bizarre. Although some urgency was required to get things rolling, completion and perfect documentation were certainly much more important in THIS case. For the Special Masters to say that they will allow Dr. Bustin to testify and then later decide whether they will consider his testimony is a very unusual decision. Nine years later, I am at a loss to decide what was worse: That such ruling happened in this very important legal proceeding or that it actually happened or is still happening in other vaccine injury compensation cases. 

The fact is, such a ruling would have been unheard of in a Real Court, with a Real Jury, Real Rules and Regulations and a Justice Scale on the wall.

One can only imagine a “Real Court” scene with the judge explaining to the Jury: “You are now going to hear some very complicated scientific information from this British scientist who was very recently discovered by DOJ, thanks to a tip from a reporter. He inspected the Unigenetics Laboratory where the Biopsy of Michelle Cedillo was tested. He also examined related laboratory notebooks and recordings. Unfortunately all those supporting documents are now sealed by a British Court and they cannot be obtained for review. In other words you are going to have to base your verdict only on what the expert who has received very large sums of money from vaccine companies producing MMR vaccines decides to tell you and base your verdict on that alone without other supporting evidence. Lastly, I don’t even know whether, when or how I may use that British expert’s information.”

On Wednesday, June 20, 2007, Dr. Bustin was sworn to tell the truth, the whole truth and nothing but the truth before he testified.

The following exchange on appeal, Judges Newman, Linn and Dyk officiating, should have been all what was needed to impeach Bustin’s appearance and testimony. Unfortunately, that did not happen.

[Judge Dyk to the DOJ Attorney -Beginning at mark 23:20]
Judge: 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?
DOJ: 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.
DOJ: Your Honor. We don't even know if the underlying materials exist and we don't know that what's...........
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 you’re gonna put on a witness to provide the materials that the witness relied on. …
DOJ: 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?
DOJ: 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?
DOJ: 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.
DOJ: 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?
DOJ: 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?
DOJ: 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?
DOJ: 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?
DOJ: And our solicitors said...yes...we honed it down to the three that we were able to get.
Judge: Three what?
DOJ: The three reports.
Judge: What about the underlying data? Did you ask for the underlying data?
DOJ: 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…” [End of quote] 

***

In her cross-examination in Vaccine Court, plaintiff’s attorney questioned Dr. Bustin about the Unigenetics Laboratory Inspection and his report for the UK MMR litigation: “I think you indicated that you spent roughly 1,500 hours at 150 pounds sterling” and he answered “Yes, that is correct.” On further questioning, Dr. Bustin testified that he received the payment checks from the solicitors but that the funds actually came from Merck, Aventis and GSK.

[Listening by phone, with my calculator handy, that inspection sounded to me like the most expensive inspection of a laboratory in history.]

When he was asked what he was paid to come to the US to testify, Dr. Bustin answered: “It’s $250 an hour while I am here and $125 an hour while I’m traveling and nothing while I’m sleeping, I think. And also my airfare and hotel are being paid for.”

[I remember thinking: “OH! He is a comedian too.”] 

Dr. Bustin also mentioned that at his regular job, his salary was 60,000 pounds or roughly $120,000 a year in 2007. If Dr. Bustin worked 40 hours a week, he was making less than 29 pounds sterling an hour at his real job. 

Because Dr. John O’Leary was an uncontested expert with a stellar reputation, as the Special Masters themselves noted, Dr. Bustin needed to produce extremely solid evidence that Michelle’s RNA results were wrong and that the laboratory where the test was performed was unreliable. He never did.

The British expert testified that his issues with Unigenetics were related to inability to detect minimal inflammation or “Low copy numbers”.

Michelle’s biopsy had revealed “high copy numbers” and only “high copy numbers” indicating extensive inflammation. Michelle never had any issue with “low copy numbers.” 

In their decision on February 12, 2009, the Special Masters mentioned that they were aware of a study by Hornig et al that was supported by a CDC grant and was published in September 2008. In that study, Real Time PCR testing was performed on biopsies similar to Michelle Cedillo’s at a Harvard University Laboratory, at the Measles, Mumps, Rubella, and Herpesvirus Laboratory Branch of the CDC and at the Department of Histopathology, Trinity College Dublin, Ireland where Dr. John O’Leary is Director.    

The authors reported that “The results were consistent across the three laboratory sites.”
http://tinyurl.com/h7whhnc 

In March 2009, Drs. Jamie Murphy and Stephen A Bustin (The same Dr. Bustin) published a report titled: “Reliability of real-time reverse-transcription PCR in clinical diagnostics: gold standard or substandard?”

The complete abstract of the report is reproduced because of the importance of its wording. “Molecular diagnostics is one of the major growth areas of modern medicine, with real-time PCR established as a qualitative and quantitative technology that is rapid, accurate and sensitive. The sequencing of the human genome, comprehensive genomic, mRNA and miRNA expression profiling of numerous cancer types, the ongoing identification of disease-associated polymorphisms and the expanding availability of genomic sequence information for human pathogens has opened the door to a wide range of translational applications for this technology. Consequently, novel real-time PCR assays have been developed for diagnosis and prognosis, treatment monitoring, transplant biology and pathogen detection, as well as more controversial uses such as lifestyle genotyping. However, this technology is still troubled by significant technical deficiencies. Hence its often-improper use as a clinical tool has important public health implications, most recently demonstrated through its association with the measles, mumps and rubella vaccine/autism controversy. This serves as a timely reminder of the indispensable requirement for careful experimental design, validation and analysis.”

http://www.ncbi.nlm.nih.gov/pubmed/19298142

It seems ludicrous that Dr. Bustin seems to trust the test and its results relative to some of the most important and most sophisticated scientific research going on in the world and yet intimates that the same test is not really reliable in identifying measles virus RNA.

In his decision, Special Master Hastings discussing petitioners’ exhibit 130 (p. 70) 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”. Yet, Special Master Hastings rejected the Shiels information 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 ]

If indeed Michelle’s identified measles exposure was not from vaccine, it would have had to be due to ONLY ONE OTHER CAUSE: Infection.

In the United States, Measles infection is reportable. According to the Arizona Department of Health, there were no measles outbreaks in the state and only 44 isolated reported cases of measles from January 1, 1994 to December 31, 2000 or on average 6 (six) cases a year. 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. Michelle’s medical records neither mention a doctor’s visit for measles nor an Arizona DOH notification for measles.

***

While in Washington DC, unless he was on the stand testifying, Dr. Bustin was most frequently seen chatting with freelance reporter Deer. This is not exactly what is expected from a so-called medical expert with no declared conflict of interest, brought across the Atlantic to testify in an important MMR-Autism related case, a subject dear to Mr. Deer and his “Raison de Vivre” for a dozen years.   

Furthermore, when one thought that we were done with “Funny Stuff”, Dr. Bustin surprised everyone by giving an interview shortly after his return to England, when the Special Masters in the case were still deliberating and before they had rendered an opinion on the case.   

On Wednesday July 4, 2007, exactly two weeks after Dr. Bustin testified in Washington DC and eight days after the end of the Hearing, Spiked Online published with great fanfare: “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.”  http://www.spiked-online.com/index.php?/site/article/3562/

According to Fitzpatrick, a physician and an outspoken enemy of Dr. Wakefield,   “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’.

Fitzpatrick went on to the real purpose of his interview, just before the GMC hearings in London “…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…”

It is likely that Deer, Fitzpatrick and Bustin celebrated when they heard the “off the wall” GMC decision and the news that Dr. Wakefield was going to lose his license to practice Medicine. It is just as likely that they never gave a second thought to what also happened to a sweet little girl in Arizona.

*****

In his Cedillo Decision, Special Master Hastings stated on page 41:

 

“THE UNIGENETICS TESTING THAT PURPORTED TO FIND

EVIDENCE OF PERSISTING MEASLES VIRUS IN THE INTESTINAL

TISSUE OF MICHELLE AND OTHERS WAS NOT RELIABLE

 

As noted above, the petitioners contend in this case that the MMR vaccine can, in general, contribute to the causation of both autism and chronic gastrointestinal dysfunction, and did contribute to the causation of Michelle Cedillo’s own autism and chronic gastrointestinal symptoms.

There is one key factual allegation that underlies all of those causation contentions. That is, all of the petitioners’ causation theories depend upon the validity of certain testing that purported to find evidence of persisting measles virus in the biological materials of Michelle and a number of other autistic children. Specifically, the petitioners’ primary expert concerning the causation of autism, Dr. Marcel Kinsbourne, made it clear that his opinion in any individual case would depend upon the existence of a reliable laboratory finding of persisting vaccine-strain measles virus in the body of the individual in question. (Tr. 1180A, 1183A, 1196A.) Similarly, the petitioners’ primary expert concerning the causation of chronic gastrointestinal dysfunction, Dr. Arthur Krigsman, also specified that his opinion in any individual case would depend upon the existence of such a reliable laboratory finding of persisting vaccine-strain measles virus in the individual. (Tr. 531-33A, 538A.)

Therefore, a key issue in this case concerns the reliability and validity of the laboratory testing that purported to find evidence of persisting measles virus in the intestinal tissue of Michelle and other autistic children.57” [End of quote]

***

Noteworthy and certainly strange is the fact that Special Master Hastings never mentioned Dr. Bustin in the above opening remarks related to the Unigenetics Laboratory Testing.

In fact, Special Master Hastings did not mention Dr. Bustin until page 49 of the document.

On page 52, Special Master Hastings summarized Bustin’s testimony: “Dr. Bustin’s overall conclusion, after his complete assessment of the Unigenetics work, was 72 that it is “clear” that, in its testing for measles virus RNA, that laboratory was erroneously detecting a DNA contaminant, and not detecting measles virus RNA. (Tr. 2035-37.) He also stated that “I do not believe there is any measles virus in any of the cases they have looked at.” (Tr. 2036, emphasis added.) He added that this opinion extended specifically to the Unigenetics test result reported for Michelle Cedillo. (Tr. 2037.)” [End of quote]  

Regarding the first two statements, Special Master Hastings is implying that he and the other two Special Masters became convinced that Michelle Cedillo was never injured by the MMR vaccination she received because Dr. Bustin said so even though:

    A: No one in the USA, including the DOJ Attorneys, had heard of Bustin three months before the Cedillo Hearing started

    B: Bustin was allowed to present highly technical information about “his inspection” even though the O’Leary Lab notebooks and documents on which most of his testimony was based, were under seal in a British court.

    C. Bustin was permitted to quote extensively from a report by someone else even though that report was also under seal and unavailable..
 
    D. Bustin had recently received obscene sums of money from three vaccine makers including Merck, the company that produced the MMR vaccine that was administered to Michelle Cedillo before she showed signs and symptoms of regressive autism.

    E. Bustin discussed the case with a British investigative reporter in Washington DC while the hearing was going on.

    F. Bustin who had respected a gag order by a British court for three years, disclosed confidential details of a yet undecided US legal proceeding upon his return to London.

It is worth noting that at the end of his introductory statement about the Laboratory testing on page 41 of his decision, Special Master Hastings stated: “Therefore, a key issue in this case concerns the reliability and validity of the laboratory testing that purported to find evidence of persisting measles virus in the intestinal tissue of Michelle and other autistic children”.

Yet on page 52, Special Master Hastings stated very clearly that “this opinion extended specifically to the Unigenetics test result reported for Michelle Cedillo. (Tr. 2037.)”

If that is so then one must ask:
    •    Why were the legal rights of ALL those other children to compensation abrogated because of Michelle’s test results and other testimony in the “First Test Case”?
    •    Why were their medical records and reported distinct vaccine adverse events never reviewed?
    •    Why were the specific findings of “Table” vaccine injuries never considered in all of those other cases?
    •    Why were over 5,000 + cases never heard, their specific findings never presented and their rights wiped out in one swift scoop?

The language and the wording of Special Master Hastings decision become extremely important if one is aware that His Honor walked over to Michelle, had a good look at her and then spoke cordially and kindly with her parents for several minutes.
 
In his decision, Special Master Hastings stated: “The petitioners in this case have advanced a causation theory that has several parts, including contentions (1) that thimerosal-containing vaccines can cause immune dysfunction, (2) that the MMR vaccine can cause autism, and (3) that the MMR vaccine can cause chronic gastrointestinal dysfunction. However, as to each of those issues, I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions. . . . Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems.”  http://www.immunize.org/catg.d/p4029.pdf

Special Master Hastings appears to be saying: “I have seen this child with my own eyes. She is certainly and tragically suffering from autism and other severe problems and her parents believe that her difficulties are due to vaccines that she received. After listening to all the testimony, I tend to believe the DOJ lawyers and their experts (even though some important documents supporting certain assessments were unavailable) more than I believe the petitioners’ lawyers and their experts. Compensation for a vaccine injury is therefore denied.”

Special Master Hastings could have added but did not: “And by the way, if by any chance, the same thing happens with the next two test cases, then the parents of the remaining 5,000 + allegedly vaccine-injured children with autism will not be able to have their cases heard through this Compensation Program.”

***


The fact that the Cedillos did not prevail does not mean at all that Michelle was not vaccine-injured and the Special Masters’ conclusion, that the DOJ evidence was more convincing, stands very clearly on shaky ground.

The unsupported Bustin testimony seriously affected the decision relative to the MMR vaccination.

In all likelihood, the Cedillo case was doomed the day it was selected as the first “TEST CASE” and so were the other two “TEST CASES”.

Because of this outrageous decision, over 5,000 other children were actually hurt twice: When they developed witnessed autistic regression or other long-lasting serious adverse events following vaccination and AGAIN, when they were all grouped in the Autism Omnibus Proceeding and swiftly robbed en masse and forever of their legal rights for compensation.



April 21, 2016
F. Edward Yazbak MD, FAAP
Falmouth, Massachusetts

 

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