The Vaccine Autism Cover-up: How One Doctor’s Career was Des

Gathered together in one place, for easy access, an agglomeration of writings and images relevant to the Rapeutation phenomenon.

Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sat Feb 27, 2016 8:54 am

CDC Whistleblower Revealed
by Dr. Andrew Wakefield
© AutismMediaChannel 2014

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[CDC WHISTLEBLOWER CONFESSES TO VACCINE-AUTISM FRAUD]

an Autism Media Channel exclusive

[Dr. William Thompson, Senior Epidemiologist at the CDC] Oh my God, I cannot believe we did what we did. But we did. It's all there. It's all there.

[DECADE-LONG COVER UP PUT MILLIONS OF INFANTS AT RISK]

[Andy Wakefield] This is a real story of a real fraud.

["... THAT PAPER"]

[Dr. William Thompson, Senior Epidemiologist at the CDC] It's the lowest point in my career, that I went along with that paper.

[Andy Wakefield] A deliberate, high-level deception of the American people with disastrous consequences for its children's health.
In order to give context to the extraordinary story that you're about to hear, a little historical perspective is important.
Many of you will have heard of Tuskegee.
Dirt-poor sharecroppers in Lincoln County, Alabama.
Black men with syphilis.
In 1932, 339 men were told by the Public Health Service,
the forerunner of today's CDC,
that they had "bad blood."

[COLORED PEOPLE. DO YOU HAVE BAD BLOOD? FREE BLOOD TESTS. FREE TREATMENT. BY COUNTY HEALTH DEPARTMENT AND GOVERNMENT DOCTORS. YOU MAY FEEL WELL AND STILL HAVE BAD BLOOD. COME AND BRING ALL YOUR FAMILY. FRIDAY.]

The motive of Public Health doctors ...
was to study the natural history of syphilis in the Black man.
"Natural history" in this case means "deliberately untreated."

[UNTREATED SYPHILIS IN THE MALE NEGRO. A COMPARATIVE STUDY OF TREATED AND UNTREATD CASES. READ BEFORE THE ANNUAL MEETING OF THE AMERICAN MEDICAL ASSOCIATION, SECTION ON DERMATOLOGY AND SYPHILOLOGY, KANSAS CITY, MOS., MAY 11-15, 1930. R.A. VONDERLEHR, ASSISTANT SURGEON GENERAL. TALIAFERRO CLARK, MEDICAL DIRECTOR (RETIRED). O.C. WENGER, SURGEON, AND J.R. HELLER JR., ASSISTANT SURGEON, UNITED STATES PUBLIC HEALTH SERVICE. A DETERMINATION OF THE EFFECTIVENESS OF TREATMENT IN PREVENTING THE TRANSMISSION OF SYPHILIS IS ONE OF THE BASIC PROBLEMS IN THE CONTROL OF THIS DISEASE. SECOND IN IMPORTANT TO IT IS THE EFFECT WHICH TREATMENT ...]

These men were deliberately left untreated ...
even when something as effective as penicillin came along.
Worse still, those infected were actively prevented by Public Health doctors ...
from getting this life-saving drug.

[HUNDREDS OF BLACK MEN DISCOVERED MASSACRED IN SYPHILIS "EXPERIMENT"]

Men suffered and died;

[SYPHILIS]

women continued being infected;
and babies continued to be born ...
with congenital syphilis.
A shiny, new CDC that took over in the late 1960s ...
refused to stop the experiment.
Not until every last man had been opened up on their autopsy table.

[MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE SECRETARY
DATE: NOV. 16, 1972
TO: Director
Center for Disease Control
THROUGH: Administrator, HS __ 11/22
FROM: Assistant Secretary for Health
SUBJECT: Termination of USPHS Study of Untreated Syphilis (the Tuskegee Study)

As recommended by the Tuskegee Syphilis Study Ad Hoc Advisory Panel, I have decided that the "Tuskegee Study" as a study of untreated syphilis must be terminated. I will advise you of the necessary steps to be taken to assure that appropriate medical care be given to all remaining participants in the "Tuskegee Study" as a part of the close-out phase of the project.
Merlin K. DuVal, M.D.
TERMINATION MEMO]


The experiment was stopped, not because the CDC realized the barbaric nature of their enterprise, but because a whistleblower by the name of Peter Buxtun ...
leaked the story to a journalist at The Washington Star.
The story was published on July 25, 1972, hit the front page of the New York Times, then the experiment was stopped shortly thereafter.
Congressional hearings followed.
So unethical, so inhumane was this Public Health experiment,
that it led to a change in the CDC's code of medical ethics. EXCEPT it didn't.
Thirty years later, the CDC was to do something arguably far worse.

[AUTISM, VIRAL INFECTION AND MEASLES-MUMPS-RUBELLA VACCINATION
BY ANDREW J. WAKEFIELD FRCS AND SCOTT M. MONTGOMERY PH.D., DEPARTMENT OF MEDICINE, ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL, LONDON, UK.
THE KEY TO UNLOCKING THE MYSTERY: CHANGING THE PATTERNS OF CHILDHOOD INFECTION
AN ANSWER TO THIS ETIOLOGICAL PUZZLE LIES IN THE CHANGING PATTERN OF EXPOSURE TO INFECTIOUS DISEASE IN CHILDHOOD. PATTERNS OF EXPOSURE TO COMMON CHILDHOOD VIRAL INFECTIONS PLAY A LARGE PART IN DETERMINING BOTH THE SEVERITY OF THE ACUTE DISEASE AND THE RISK AND NATURE OF DELAYED CONSEQUENCES OF INFECTION. ACTING POSSIBLY THROUGH BYSTANDER MECHANISMS, CHILDHOOD EXPOSURE TO MICROBIAL ANTIGENS ALSO PLAYS A CRUCIAL ROLE IN EARLY IMMUNE PROGRAMMING AND, THUS, THE SUBSEQUENT HANDLING OF ENVIRONMENTAL ANTIGENS UNRELATED TO THE ORIGINAL INFECTION [12]. ONCE AGAIN THE PATTERN OF EXPOSURE MAY BE FUNDAMENTAL TO THE INTEGRITY OF THIS IMMUNE PROGRAMMING.
PATTERNS OF EXPOSURE TO COMMON CHILDHOOD INFECTIONS ...]


Over a decade ago, Dr. Scott Montgomery and I put forward a hypothesis for MMR vaccine and autism. The age that you receive the vaccine influences the risk. This makes sense, for some infections, like measles, the age of infection changes the outcome.
We shared this hypothesis with vaccine officials, members for the Centers for Disease Control, at meetings in Washington, D.C.,
and Cold Spring Harbor.
A group of senior vaccine safety people at the CDC studied it. It panned out.
We were right. At least partly.

[SAMPLE SELECTION FOR MMR/AUTISM STUDY]

By November 9, 2001, nearly 13 years ago,
senior CDC scientists knew that younger age of exposure to MMR ...
was associated with an increased risk of autism.
In 2004 they published.
But they hid the results.

[Dr. William Thompson, Senior Epidemiologist at the CDC] It's the lowest point in my career, that I went along with that paper.
And I went along with this, we didn't report significant findings.

[Andy Wakefield] MMR was declared safe.

[DR. COLEEN BOYLE TESTIFIED BEFORE THE OVERSIGHT COMMITTEE ON GOVERNMENT REFORM]

[Dr. Coleen Boyle] The IOM has evaluated this issue back in 2004, and again most recently in 2011, and their conclusion, not just looking at the work that was done at CDC, but with the total body of evidence, was suggesting that vaccines and their components did NOT increase the risk of AUTISM.

[Andy Wakefield] What Dr. Coleen Boyle, the co-author of that blighted paper did NOT tell Congress, is that she and her colleagues had deliberately concealed the autism-vaccine link from the Institute of Medicine, and the public.
Ironically, they even received an award from the Secretary of Health and Human Services for this work.

[LANDMARK PUBLICATIONS: MADDSP. HHS SECRETARY'S AWARD FOR DISTINGUISHED SERVICE: THE AUTISM PUBLIC HEALTH RESPONSE TEAM. DESTAFANO F, KARAPURKAR T, THOMPSON WILLIAM, YEARGIN-ALLSOPP M, BOYLE C. AGE AT FIRST MEASLES-MUMPS-RUBELLA VACCINATION IN CHILDREN WITH AUTISM AND SCHOOL-MATCHED CONTROLS PEDIATRICS 2004;113(2):259-266.]

So troubling was the fraud, that one of the CDC researchers broke ranks.
Eventually he made contact with Dr. Brian Hooker, father of a vaccine-injured child with autism, and a vaccine safety researcher.

[Brian Hooker, Ph.D.] Uh, I received a phone call out of the blue. It had a 404 area code, so I knew it was from the CDC.
And lo and behold, it was Bill Thompson. He had much to confess.

[Dr. William Thompson, Senior Epidemiologist at the CDC] I'm completely ashamed of what I did. I have great shame now. I was complicit, and uh, I went along with this.

[Brian Hooker, Ph.D.] Dr. Thompson had appointed me his priest. And when he appointed me his priest, then he started confessing. And we have had many, many phone exchanges. We've exchanged dozens of emails. And he has released quite compelling information regarding fraud and malfeasance in the CDC.

[Dr. William Thompson, Senior Epidemiologist at the CDC] We didn't report significant findings.

[Andy Wakefield] Thompson sent Hooker information that was never intended for public scrutiny.
From their own data sheets, dated 2001,
Dr. Hooker analyzed the CDCs results,
and he found the same risk of autism that the CDC scientists had themselves identified.

[Dr. William Thompson, Senior Epidemiologist at the CDC] It's all there! It's all there!

[Andy Wakefield] He confronted Thompson.

[Brian Hooker, Ph.D.] He has expressed significant remorse for lying, for burying data.

[Dr. William Thompson, Senior Epidemiologist at the CDC] I have great shame now when I meet families with kids with autism, because I have been part of the problem.

[Andy Wakefield] This week, August 10, 2014, Dr. Hooker published the real findings:
A 340% increased risk of autism ...
in boys receiving the MMR on time compared with those receiving it later.
Thirteen years,
and tens of thousands of children later.
As I've said, Dr. Montgomery and I were only partly right.
The risk of autism from early MMR vaccination was seen in Black children,
Black boys.
Those boys for some reason are at very high risk.
Consistent with the CDC's own findings,
the rate of autistic regression in Black children is reported to be twice that in white children.

[RACIAL DIFFERENCES IN DEVELOPMENTAL REGRESSION IN CHILDREN WITH AUTISM SPECTRUM DISORDERS. BY ADIAHA SPINKS-FRANKLIN, AMY SHUI, ROCHELLE SEXTON, JENNIFER B. SWANSON, ROBERT G. VOIGT. PEDIATRICS, TEXAS CHILDREN'S HOSPITAL/BAYLOR COLLEGE OF MEDICINE, HOUSTON, TX; BIOSTATISTICS, MASSACHUSETTS GENERAL HOSPITAL, BOSTON, MA.
BACKGROUND: AUTISM SPECTRUM DISORDERS (ASD) ARE COMMON NEURODEVELOPMENTAL DISORDERS THAT OCCUR IN 1 IN 88 CHILDREN. IT HAS BEEN REPORTED THAT APPROXIMATELY ONE THIRD OF CHILDREN WITH ASD HAVE DEVELOPMENTAL REGRESSION. WHILE THERE ARE NO REPORTED GENDER DIFFERENCES IN RATES OF REGRESSION, IT IS UNKNOWN WHETHER THERE ARE RADICAL DISPARITIES IN RATES OF REGRESSION.
OBJECTIVE: TO DETERMINE THE RATE OF DEVELOPMENTAL REGRESSION, AND WHETHER RACIAL DISPARITIES EXIST IN THE RATE OF REGRESSION, AMONG PRESCHOOL-AGED CHILDREN IN THE AUTISM TREATMENT NETWORK (ATN) DATABASE.
DESIGN/METHODS: SUBJECTS INCLUDED ALL NON-HISPANIC BLACK, NON-HISPANIC WHITE, AND HISPANIC CHILDREN AGES 37-71 MONTHS IN THE ATN DATABASE WITH DATA FROM A PARENT FORM REPORTING WHETHER EACH CHILD EXPERIENCED DEVELOPMENTAL REGRESSION. THE RATE OF REPORTED DEVELOPMENTAL REGRESSION WAS DETERMINED, AND THE RATE OF REGRESSION BY RACE WAS EVALUATED. LOGISTIC REGRESSION ANALYSIS WAS ...]


[Dr. William Thompson, Senior Epidemiologist at the CDC] Oh my God, I cannot believe we did what we did.

[Andy Wakefield] Tuskegee revisited.
Scientist Dr. David Lewis, an international expert in whistle blowing and the detection of scientific fraud, reviewed the original CDC documents and the paper they published in 2004.

[Dr. David Lewis, Ph.D., Research Microbiologist] Probably this is the clearest case,
and the easiest case, in which to answer "Is it fraud, or is it an accident,
or it is just an artifact of the study?" What we're dealing with here, clearly is fraud.

[Brian Hooker, Ph.D.] He knows that he is culpable for damage. He knows that he's culpable for permanent damage of a large, significant portion of the population in the United States.

The Obama administration has granted whistleblower immunity to a federal government scientist that claimed he intentionally omitted information in a study that could have shown a race-based link between vaccines and childhood diseases including autism.

-- Obama Admin Grants Immunity To CDC Scientist That Fudged Vaccine Report … Whistleblower Plans To Testify Before Congress, by Patrick Howley


[Dr. William Thompson, Senior Epidemiologist at the CDC] The higher ups wanted to do certain things, and I went along with it.

[Andy Wakefield] Dr. Frank DeStefano, Dr. Marshalyn Yeargin-Allsopp, and Dr. Coleen Boyle. They knew, they let it happen, and they could have stopped it.
Michigan lawyer Allison Folmar,
an award-winning advocate for children and parental rights, gave her reaction.

[Allison Folmar, Lawyer] Um, I feel, first and foremost as a human being, you know, betrayed.
When you lose your faith and trust in humanity, you know,
how do you repair that?
I mean, I don't even know what to say to be honest.

[Brian Hooker, Ph.D.] Thompson is very regretful about his involvement.

[Dr. William Thompson, Senior Epidemiologist at the CDC] It's the lowest point in my career that I went along with that paper.
And I'm not going to lie. Um, I basically have stopped lying.

[Andy Wakefield] You see, vile as the crimes of Stalin,
Pol Pot,
and Hitler were, these men were not hypocrites,
their motives ambiguous,
or their rhetoric [inaudible] with apparent caring and compassion.
These men were not entrusted with the welfare of their victims.
Their mottos did not include the words ...
"To Save Lives and Protect."
They were not running a mandatory program disguised as caring.
How many children?
How many went to the war in that decade of science?
How many presidents, Mr. Obama?

AUTISM MEDIA CHANNEL, copyright 2014
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 3:53 am

Letter to Julie L. Gerberding, M.D., Director, Centers for Disease Control and Prevention
from Dave Weldon, M.D., House of Representatives
October 31, 2003

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.


WASHINGTON OFFICE
2347 RAYBURN HOUSE OFFICE BUILDING
WASHINGTON, DC 20515
(202_225-3571

DISTRICT OFFICE:
BREVARD CO. GOVT. COMPLEX
2725 JUDGE FRAN JAMESON WAY
BUILDING C
MELBOURNE, FL 32940
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https://www.house.gov/weldon

Congress of the United States
House of Representatives
Washington, DC 20515

DAVE WELDON, M.D.
15TH DISTRICT, FLORIDA
COMMITTEE
APPROPRIATIONS
SUBCOMMITTEES
VA, HUD, INDEPENDENT AGENCIES
LABOR, HEALTH AND HUMAN SERVICES
THE DISTRICT OF COLUMBIA

October 31, 2003

Julie L. Gerberding, M.D., M.P.H.
Director, Centers for Disease Control and Prevention
1600 Clifton Road, N .E.
Atlanta, GA 30333

Dr. Julie Gerberding,

I am writing to follow up on our conversation about the article (Verstraeten et. al.,) that will be published in the November 2003 issue of Pediatrics. I have reviewed the article and have serious reservations about the four-year evolution and conclusions of this study.

Much of what I observed transpired prior to your appointment a year ago as the Director of the Centers for Disease Control and Prevention (CDC). I am very concerned about activities that have taken place in the National Immunization Program (NIP) in the development of this study, and I believe the issues raised need your personal attention.

I am a strong supporter of childhood vaccinations and know that they have saved us from considerable death and suffering. A key part of our vaccination program is to ensure that we do everything possible to ensure that these vaccines, which are mandatory, are as safe as possible. We must fully disclose adverse events. Anything less than this undermines public confidence.

I have read the upcoming Pediatrics study and several earlier versions of this study dating back to February 2000. I have read various e-mails from Dr. Verstraeten and coauthors. I have reviewed the transcripts of a discussion at Simpsonwood, GA between the author, various CDC employees, and vaccine industry representatives. I found a disturbing pattern which merits a thorough, open, timely, and independent review by researchers outside of the CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues (including many in University settings who may have conflicts).

A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a selective use of the data to make the associations in the earliest study disappear.
While most childhood vaccines now only have trace amounts of mercury from thimerosal containing vaccines (TCVs), it is critical that we know with certainty if children were injured in the 1990s.

Furthermore, the lead author of the article, Dr. Thomas Verstraeten, worked for the CDC until he left over two years ago to work in Belgium for GlaxoSmithKline (GSK), a vaccine manufacturer facing liability over TCVs. In violation of their own standards of conduct, Pediatrics failed to disclose that Dr. Verstraeten is employed by GSK and incorrectly identifies him as an employee of the CDC. This revelation undermines this study further.

The first version of the study, produced in February 2000, found a significant association between exposure to thimerosal containing vaccines (TCV s) and autism and neurological developmental delays (NODs).
When comparing children exposed to 62.5 pg of mercury by 3 months of age to those exposed to less than 37.5 pg, the study found a relative risk for autism of 2.48 for those with a higher exposure level. (While not significant in the 95% confidence interval for autism, this meets the legal standard of proof exceeding 2.0.) For NODs the study found a relative risk of 1.59 and a definite upward trend as exposure levels increased.

A June 2000 version of the study applied various data manipulations to reduce the autism association to 1.69 and the authors went outside of the VSD database to secure data from a Massachusetts HMO (Harvard Pilgrim, HP) in order to counter the association found between TCV s and speech delay. At the time that HP's data was brought in, HP was in receivership by the state of Mass., its computer records had been in shambles for years, it had multiple computer systems that could not communicate with one another (Journal of Law, Ethics and Medicine Sept. 22, 2000), and it used a health care coding system totally different from the one used across the VSD. There are questions relating to a significant underreporting of Autism in Mass. The HP dataset is only about 15% of the HMO dataset used in the February 2000 study. There may also be significant problems with the statistical power of the HP dataset.

In June of 2000 a meeting was held in Simpsonwood, GA, involving the authors of the study, representatives of the CDC, and the vaccine industry. I have reviewed a transcript of this meeting that was obtained through the Freedom of Information Act (FOIA). Comments from Simpsonwood, NJ meeting include: (summary form, not direct quotes):

• We found a statistically significant relationship between exposures and outcomes. There is certainly an under ascertainment of adverse outcomes because some children are just simply not old enough to be diagnosed, the current incidence rates are much lower than we would expect to see (Verstraeten);

• We could exclude the lowest exposure children from our database. Also suggested was removing the children that got the highest exposure levels since they represented an unusually high percentage of the outcomes. (Rhodes)

• The significant association with language delay is quite large. (Verstraeten);

• This information should be kept confidential and considered embargoed;

• We can push and pull this data anyway we want to get the results we want;

• We can alter the exclusion criteria any we way we want, give reasonable justifications for doing so, and get any result we want;


• There was really no need to do this study. We could have predicted the outcomes;

• I will not give TCV s to my grandson until I find out what is going on here.

Another version of the study -- after further manipulation -- finds no association between TCV s and autism, and no consistency across HMOs between TCVs and NODs and speech delay.

The final version of the study concludes that "No consistent significant associations were found between TCVs and neurodevelopmental outcomes," and that the lack of consistency argues against an association. In reviewing the study there are data points where children with higher exposures to the neuortoxin mercury had fewer developmental disorders. This demonstrates to me how excessive manipulation of data can lead to absurd results. Such a conclusion is not unexpected from an author with a serious, though undisclosed, conflict of interest.

This study increases speculation of an association between TCVs and neurodevelopmental outcomes. I cannot say it was the author's intent to eliminate the earlier findings of an association. Nonetheless, the elimination of this association is exactly what happened and the manner in which this was achieved raises speculation. The dialogue at the Simpsonwood meeting clearly indicates how easily the authors could manipulate the data and have reasonable sounding justifications for many of their decisions.

The only way these issues are going to be resolved -- and I have only mentioned a few of them -- is by making this particular dataset and the entire VSD database open for independent analysis. One such independent researcher, Dr. Mark Geier, has already been approved by the CDC and the various IRBs to access this dataset. They have requested the CDC allow them to access this dataset and your staff indicated to my office that they would make this particular dataset available after the Pediatrics study is published.

Earlier this month the CDC had prepared three similar datasets for this researcher to review to allow him to reanalyze CDC study datasets. However when they accessed the datasets -- which the researchers paid the CDC to assemble -- the datasets were found to have no usable data in them. I request that you personally intervene with those in the CDC who are assembling this dataset to ensure that they provide the complete dataset, in a usable format, to these researchers within two weeks. The treatment that these well-published researchers have received from the CDC thus far has been abysmal and embarrassing. I would also be curious to know whether Dr. Verstraeten, an outside researcher for more than two years now, was required to go through the same process as Dr. Geier in order to continue accessing the VSD.

You have not been a part of creating this current situation, but you do have an opportunity to help resolve this issue and ensure that confidence and trustworthiness in the CDC and our national vaccination program is fully restored. I would ask that you work with me to ensure that a full, fair, and independent review is made of the VSD database to fully examine this matter. I would like to meet with you at your earliest convenience to move this process forward.

Thank you for your consideration. I look forward to working with you on this urgent matter of great importance to our nation's most precious resource, our children.

Sincerely,

Dave Weldon, M.D.
Member of Congress
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 4:46 am

Missing the Mercury Menace?
by Neil Munro
National Journal
1/3/04

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

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Image
Julie Gerberding: The CDC director faces a dispute over mercury in vaccines that is likely to heat up soon.

Parents of autistic children are vigorously challenging a new study by the Centers for Disease Control and Prevention. The study concludes there is no consistent evidence that a mercury-based preservative in CDC-mandated vaccines has caused an increase in the number of children with autism.

A CDC official who helped write the study accepted the critics' charge that it contained many children too young to be diagnosed as autistic. "This is true," said scientist Frank DeStefano.

The CDC's manipulation of the study data, say the parents, hides the true autism rate and obscures the link between autism and vaccinations. The parents and some scientists argue that the large increase in autism rates over the past decade was likely caused by some children's genetic vulnerability to mercury in additional vaccines that the CDC mandated after 1990. The mercury is in a preservative called thimerosal.

After 1999, vaccine makers ended the use of mercury in routine childhood vaccinations, following a request from government officials -- although the officials never stated that the mercury was harmful. But the mercury dispute is likely to heat up soon because CDC Director Julie Gerberding and Health and Human Services Secretary Tommy Thompson are weighing a proposal by a panel of vaccine experts to give children between the ages of 6 months and 23 months as many as five flu shots. Gerberding and Thompson can recommend that the flu shots be mercury-free, or they can allow many additional children to receive mercury-laden shots.

The CDC would not say whether Gerberding will urge that thimerosal be left out of the 2004 flu vaccines. According to Rep. Dave Weldon, R-Fla., Gerberding has said she is considering whether to appoint an outside ombudsperson to investigate the possible link between autism and mercury. Weldon, a physician, wants the data used in the new study to be shared with outside researchers.

This seemingly arcane fight has enormous stakes. If the parents are right, then many infants overseas are endangered by vaccines that contain mercury. Moreover, American parents could follow the example of parents in the U.K., where the public distrust of the government's vaccination professionals has reduced vaccination rates and spurred harmful outbreaks of measles and other diseases. Several pharmaceutical companies could be forced to pay billions of dollars if parents' groups are victorious in anti-thimerosal lawsuits in which the CDC study and other reports are being used as ammunition. This fight has already reached Congress: In early 2003, Democratic senators defeated a Republican effort to win legal protections for the companies that made thimerosal-containing vaccines.

The CDC's report, published in the November issue of Pediatrics, summarized a three-year study of brain-related diseases in children. The study, titled "Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases," began in 1999. It was conducted by a panel of four CDC vaccine experts and four employees of the two HMOs that provided data on more than 100,000 children. The study examined the incidence of a wide variety of medical problems and concluded that no consistent connection existed between the mercury-containing vaccines and the diagnoses neurological problems in children born between January 1992 and December 1998. Overall, "the risk [of autism] does not change ... from the lowest level of exposure [to thimerosal] to the highest level," DeStefano said.

But to reach this conclusion, CDC experts reduced by roughly 45 percent the number of children in the study who were age 4 or older, said Mark Blaxill, a member of Safe Minds, an Atlanta group that opposes the use of mercury in vaccines. Because autism is normally diagnosed only after age 4, the CDC's method greatly reduced the number of children in the study who could be found with autism, Blaxill said.

According to the report, the older children were excluded because their health records were incomplete. DeStefano declined to say why the CDC did not exclude a comparable proportion of the younger children, to balance out the age groups in the study. "We could follow up on it" by launching another study, he said.

The CDC's exclusion of the older children is akin to excluding many older people from a study on the hazards of smoking, said Mark Geier, a geneticist and a vaccine specialist for 25 years. Geier has investigated the mercury issue for Weldon and gives expert-witness testimony on behalf of parents and some companies in vaccine-related lawsuits.

Blaxill said the CDC's professionals also disguised the incidence of autism by treating early symptoms of autism as other illnesses. For example, many autistic children are initially classified before age 4 as having speech and language delays or "misery disorder." The inclusion of many children too young to be definitively diagnoses with autism would result in autistic children's being mislabeled with other ailments, such as those very speech or language delays, Blaxill said. "It is true," DeStefano said, that the study could have mislabeled young autistic children. But, he added, "this study just provided an initial evaluation." CDC officials are now preparing a follow-up study of 300 autistic children and 900 other children, for publication in 2006, he said.

The new study's database was divided by gender for some analyses, but the results were combined in tables for the final article in Pediatrics. Because as many as 90 percent of autistics are boys, these tables hide links between autistic boys and mercury amid a population of relatively healthy girls, Geier said. He says that such an approach is like using men's low rates of breast cancer to downplay the cancer's rate in women. A CDC statement said the analysis of boys and girls "mirrored the results" in the Pediatrics article.

CDC officials also divided the study into many small studies and then highlighted the differences in the sub-study results to dismiss a link between autism and mercury, Blaxill said. For example, he said, the data from the larger of the two HMOs showed a link between mercury and autism, but CDC professionals tried to discredit the link by citing differences in the second HMO's data set, which was only one-eighth as large as the first one's sample. The CDC should have either set aside the data from the smaller HMO, or combined all the HMO data, Blaxill said.

"If we had done that," DeStefano countered, "the results from [the larger] HMO-B would have overwhelmed [the smaller] HMO-A." Instead, the scientists tried to perform the same analysis on both HMO data sets, in hopes of discovering a matching trend, he said.

Image
Dave Weldon: A physician, he wants CDC data on mercury and autism to be shared with outside researchers.

Blaxill cited data prepared by the CDC authors in 2000 and released under a Freedom of Information Act request lodged by Safe Minds. The figures showed that the rate of "neurodevelopmental disorder" -- a catchall term that encompasses autism -- was six times as great among 14,739 children given more than 75 micrograms of mercury by the third month of life as it was among 4,510 children who were given no mercury.

With Weldon's backing, Geier won limited access to the CDC database used in the new study and then looked at those children who got diphtheria, tetanus, and pertussis shots both with and without mercury. This analysis showed "more than a twentyfold increase in autism" among the children who got mercury in four of these shots, Geier said.

Statements in government e-mails, in conversations and in documents obtained under Safe Minds' FOIA request have intensified the parents' suspicion of DeStefano and the CDC. In a July 2000 meeting of the study's authors and advisers, Richard Johnston, a pediatrics professor at the University of Colorado, said, "I do not want [my] grandson to get a thimerosal-containing vaccine until we know better what is going on." Johnson confirmed he said this, but would not comment on the CDC study, because he has joined a pending review of the controversy at the Institute of Medicine. The Institute is part of the private National Academy of Sciences.

The Chairman of the CDC study, Thomas Verstraeten, has come under critics' scrutiny because he left the CDC to tak ea job with vaccine maker Glaxo-SmithKline. Yet according to e-mails and transcripts obtained by Safe Minds, in 2000 Verstraeten urged fellow CDC officials to carefully consider a link between mercury and autism: "I do not wish to ... sound like being convinced that thimerosal is or was harmful, but at least I feel we should use sound scientific argumentation and not let our standards be dictated by our desire to disprove an unpleasant theory." Once Verstraeten had joined Glaxo-SmithKline, "his involvement in this study was limited to reviewing drafts of the manuscript," according to a CDC statement.

Since 1990, an increasing number of children have been diagnosed with the most acute form of autism. In the 1980s, this diagnosis was given annually to roughly 1 in 10,000 children. But since then, experts have reported a huge increase. In five counties surrounding Atlanta, the rate has grown to roughly 1 in 325 children, according to a CDC study. According to the Education Department, 65,396 autistic children were in federal school programs in 2000, up from 12,222 in 1993. The 2000 total included few children under age 6.

Few adult autistics can work. Lifetime health care, therapy, and support costs amount to more than $1 million. Parents initially bear the financial burden, but as the children become adults, the costs shift to the states or the federal government.

Some parents of autistic children say vaccinations gave their children more than 100 times the maximum intake of mercury recommended by the Environmental Protection Agency. One of those parents is Lyn Redwood, a founder of Safe Minds. She is a nurse and the mother of a 9-year-old autistic boy, Will. "I have 'before [vaccination]' pictures where he is smiling, gorgeous, and looking at the camera, and I have 'after' pictures .. and there's a shell of a child left," she said.

The author can be reached at nmunro@nationaljournal.com
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 5:16 am

New Published Study Verifies Andrew Wakefield’s Research on Autism – Again
by healthimpactnews.com
March 11, 2013

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Controversial Doctor and Autism Media Channel Director proven right: MMR Vaccine Causes Autism & Inflammatory Bowel Disease

Autism Media Channel [1]

Two landmark events -– a government concession in the US Vaccine Court, and a groundbreaking scientific paper -– confirm that physician, scientist, and Autism Media Channel [AMC] Director, Dr. Andrew Wakefield, and the parents were right all along.

In a recently published December 13, 2012 vaccine court ruling, hundreds of thousands of dollars were awarded to Ryan Mojabi, [i] whose parents described how “MMR vaccinations,” caused a “severe and debilitating injury to his brain, diagnosed as Autism Spectrum Disorder (‘ASD’).”

Later the same month, the government suffered a second major defeat when young Emily Moller from Houston won compensation following vaccine-related brain injury that, once again, involved MMR and resulted in autism. The cases follow similar successful petitions in the Italian and US courts (including Hannah Poling [ii], Bailey Banks [iii], Misty Hyatt [iv], Kienan Freeman [v], Valentino Bocca [vi], and Julia Grimes [vii]) in which the governments conceded or the court ruled that vaccines had caused brain injury. In turn, this injury led to an ASD diagnosis. MMR vaccine was the common denominator in these cases.

And today, scientists and physicians from Wake Forest University, New York, and Venezuela, reported findings that not only confirm the presence of intestinal disease in children with autism and intestinal symptoms, but also indicate that this disease may be novel. [viii] Using sophisticated laboratory methods Dr. Steve Walker and his colleagues endorsed Wakefield’s original findings by showing molecular changes in the children’s intestinal tissues that were highly distinctive and clearly abnormal.

From 1998 Dr. Wakefield discovered and reported intestinal disease in children with autism. [ix] Based upon the medical histories of the children he linked their disease and their autistic regression to the Measles, Mumps, Rubella (MMR vaccine). He has since been subjected to relentless personal and professional attacks in the media, and from governments, doctors and the pharmaceutical industry. In the wake of demonstrably false and highly damaging allegations of scientific fraud by British journalist Brian Deer and the British Medical Journal, Dr. Wakefield is pursuing defamation proceedings against them in Texas. [x]

While repeated studies from around the world confirmed Wakefield’s bowel disease in autistic children [xi] and his position that safety studies of the MMR are inadequate, [xii] Dr. Wakefield’s career has been destroyed by false allegations. Despite this he continues to work tirelessly to help solve the autism catastrophe.

The incidence of autism has rocketed to a risk of around 1 in 25 for children born today.
Meanwhile governments, absent any explanation and fearing loss of public trust, continue to deny the vaccine autism connection despite the concessions in vaccine court.

Speaking from his home in Austin, Texas, Dr. Wakefield said,

There can be very little doubt that vaccines can and do cause autism. In these children, the evidence for an adverse reaction involving brain injury following the MMR that progresses to an autism diagnosis is compelling. It’s now a question of the body count. The parents’ story was right all along. Governments must stop playing with words while children continue to be damaged. My hope is that recognition of the intestinal disease in these children will lead to the relief of their suffering. This is long, long overdue.”


Dr. Andrew Wakefield is a best selling author, [xi] founder of the autism research non profit Strategic Autism Initiative (SAI), and Director of the Autism Media Channel.

“Identification of Unique Gene Expression Profile in Children with Regressive Autism Spectrum Disorder (ASD) and Ileocolitis [2]” PLOS ONE March 8, 2013, available online at: http://dx.plos.org/10.1371/journal.pone.0058058 [2]

______________

References

[i] Decision Awarding Damages to Ryan Mohabi 13 Dec 2012 [3]

[ii] Family to Receive $1.5M+ in First-Ever Vaccine-Autism Court Award [4] September 9, 2010 2:14 PM

and

Decision Awarding Damages 21 July 2012 [5]

[iii] http://www.uscfc.uscourts.gov/sites/def ... -0738V.pdf [6] (see footnote 4)

[iv] Vaccine Case: An Exception Or A Precedent? [7] February 11, 2009 3:20 PM CBS News By Sharyl Attkisson

[v] KIENAN FREEMAN RULING CONCERNING “ENTITLEMENT” [8] – September 25, 2003

[vi] MMR: A mother’s victory. The vast majority of doctors say there is no link between the triple jab and autism, but could an Italian court case reignite this controversial debate? [9] By Sue Reid – Daily Mail15 June 2012

[vii] JULIA GRIMES – DECISION AWARDING DAMAGES [10] January 12, 2011

[viii] Walker S., Fortunado J, Krigsman A., Gonzalez L. Identification of Unique Gene Expression Profile in Children with Regressive Autism Spectrum Disorder (ASD) and Ileocolitis [2]

[ix] Wakefield AJ. Callous Disregard: Autism and Vaccines – The Truth Behind a Tragedy [11]. 2010. Skyhorse Publishing, NY, NY. Chapter 1, footnotes 1 & 4, p.20

[x] For Affidavits see http://www.DrWakefieldJusticeFund.org [12]

[xi] Wakefield AJ. Waging War on the Autistic Child [13]. 2012 Skyhorse Publishing NY, NY. Chapter 2, footnotes 2 11, pp. 255 256

[xii] Jefferson T et al, Unintended events following immunization with MMR: a systematic review. Vaccine 21 (2003) 3954–3960

Source: Press Release from Autism Media Channel [1]

Here is a list of 28 studies from around the world that support Dr. Wakefield’s research:

The Journal of Pediatrics November 1999; 135(5):559-63 [14]
The Journal of Pediatrics 2000; 138(3): 366-372 [15]
Journal of Clinical Immunology November 2003; 23(6): 504-517 [16]
Journal of Neuroimmunology 2005 [17]
Brain, Behavior and Immunity 1993; 7: 97-103 [18]
Pediatric Neurology 2003; 28(4): 1-3 [19]
Neuropsychobiology 2005; 51:77-85 [20]
The Journal of Pediatrics May 2005;146(5):605-10 [21]
Autism Insights 2009; 1: 1-11 [22]
Canadian Journal of Gastroenterology February 2009; 23(2): 95-98 [23]
Annals of Clinical Psychiatry 2009:21(3): 148-161 [24]
Journal of Child Neurology June 29, 2009; 000:1-6 [25]
Journal of Autism and Developmental Disorders March 2009;39(3):405-13 [26]
Medical Hypotheses August 1998;51:133-144 [27].
Journal of Child Neurology July 2000; ;15(7):429-35 [28]
Lancet. 1972;2:883–884 [29].
Journal of Autism and Childhood Schizophrenia January-March 1971;1:48-62 [30]
Journal of Pediatrics March 2001;138:366-372 [31].
Molecular Psychiatry 2002;7:375-382 [32].
American Journal of Gastroenterolgy April 2004;598-605 [33].
Journal of Clinical Immunology November 2003;23:504-517 [34].
Neuroimmunology April 2006;173(1-2):126-34 [35].
Prog. Neuropsychopharmacol Biol. Psychiatry December 30 2006;30:1472-1477. [36]
Clinical Infectious Diseases September 1 2002;35(Suppl 1):S6-S16 [37]
Applied and Environmental Microbiology, 2004;70(11):6459-6465 [38]
Journal of Medical Microbiology October 2005;54:987-991 [39]
Archivos venezolanos de puericultura y pediatría 2006; Vol 69 (1): 19-25.
Gastroenterology. 2005:128 (Suppl 2);Abstract-303
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 5:33 am

Family to Receive $1.5M+ in First-Ever Vaccine-Autism Court Award
By Sharyl Attkisson
CBS News
September 10, 2010

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

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Image
On July 20, 2010, respondent filed a Proffer on Award of Compensation (Proffer). On July 20, 2010, petitioners orally accepted respondent's Proffer. Based on the record as a whole, the undersigned finds that petitioners are entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, the court awards petitioners:

1. A lump sum payment of $1,507,284.67, representing compensation for life care expenses expected to be incurred during the first year after judgment ($624,713.32), lost future earnings ($674,410.67) and pain and suffering ($208,160.68), in the form of a check payable to petitioners, as the court appointed guardian(s)/conservator(s) of the estate of Child Doe/77, for the benefit of Child Doe/77. No payments shall be made until petitioners provide respondent with documentation establishing that they have been appointed as the guardian(s)/conservator(s) of Child Doe/77's estate;

2. A lump sum payment of $140,109.67, representing compensation for past unreimbursable expenses, payable to John and Jane Doe/77, petitioners;


Image
Nine-year-old Hannah Poling is shown. (AP Photo/Atlanta Journal-Constitution, John Spink)

The first court award in a vaccine-autism claim is a big one. CBS News has learned the family of Hannah Poling will receive more than $1.5 million dollars for her life care; lost earnings; and pain and suffering for the first year alone.
In addition to the first year, the family will receive more than $500,000 per year to pay for Hannah's care. Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime.

Hannah was described as normal, happy and precocious in her first 18 months.

Then, in July 2000, she was vaccinated against nine diseases in one doctor's visit: measles, mumps, rubella, polio, varicella, diphtheria, pertussis, tetanus, and Haemophilus influenzae.

Afterward, her health declined rapidly. She developed high fevers, stopped eating, didn't respond when spoken to, began showing signs of autism, and began having screaming fits. In 2002, Hannah's parents filed an autism claim in federal vaccine court. Five years later, the government settled the case before trial and had it sealed. It's taken more than two years for both sides to agree on how much Hannah will be compensated for her injuries.

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

care expenses expected to be incurred during the first year after judgment ($624,713.32), lost future earnings ($674,410.67) and pain and suffering ($208,160.68), in the form of a check payable to petitioners, as the court appointed guardian(s)/conservator(s) of the estate of Child Doe/77, for the benefit of Child Doe/77. No payments hall be made until petitioners provide respondent with documentation establishing that they have been appointed as the guardian(s)/conservator(s) of Child Doe/77's estate;


Time Magazine summed up the relevance of the Poling case in 2008: ...(T)here's no denying that the court's decision to award damages to the Poling family puts a chink -- a question mark -- in what had been an unqualified defense of vaccine safety with regard to autism. If Hannah Poling had an underlying condition that made her vulnerable to being harmed by vaccines, it stands to reason that other children might also have such vulnerabilities."

Then-director of the Centers for Disease Control Julie Gerberding (who is now President of Merck Vaccines) stated: "The government has made absolutely no statement indicating that vaccines are a cause of autism. This does not represent anything other than a very specific situation and a very sad situation as far as the family of the affected child."

Read the newly-released decision on Hannah Poling's compensation.

© 2010 CBS Interactive Inc. All Rights Reserved.
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 6:51 am

DECISION AWARDING DAMAGES: CHILD DOE/77, a minor, by [DELETE] Parents and Natural Guardians, JANE DOE/77 AND JOHN DOE/77, v. SECRETARY OF HEALTH AND HUMAN SERVICES
MMR Vaccine; Thimerosal-Containing Vaccines; Autism Spectrum Disorder; Finding of Entitlement; Damages Decision Based On Proffer

by the United States Court of Federal Claims, OFFICE OF SPECIAL MASTERS
July 20, 2010

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

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[DELETE]
[DELETE]

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
(E-Filed: July 21, 2010; Re-Issued: July 22,2010;
Re-Issued for Redaction: July 23, 2010; Re-issued for Redaction: August 27, 2010)

CHILD DOE/77, a minor,
by [DELETE] Parents and Natural Guardians,
JANE DOE/77 AND JOHN DOE/77,
Petitioners,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent.

MMR Vaccine; Thimerosal-Containing Vaccines; Autism Spectrum Disorder; Finding of Entitlement; Damages Decision Based On Proffer

[DELETE]
Special Master Campbell-Smith

TO PUBLISH

Clifford J. Shoemaker, Vienna, VA, for petitioners

Catharine E. Reeves, Washington, DC, for respondent

CAMPBELL-SMITH, Special Master

DECISION AWARDING DAMAGES [1]

On October 25,2002, petitioners, John and Jane 00e177, filed a petition on behalf of their minor child seeking compensation under the National Vaccine Injury Compensation Program ("the Vaccine Program") for a vaccine-related injury. [2]

Respondent has conceded that petitioners are entitled to compensation due to the significant aggravation of Child Doc/77's pre-existing mitochondrial disorder based on an MMR vaccine Table presumptive injury of encephalopathy, which eventually manifested as a chronic encephalopathy with features of autism spectrum disorder and a complex partial seizure disorder as a sequela.

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

On July 20, 2010, respondent filed a Proffer on Award of Compensation (Proffer). On July 20, 2010, petitioners orally accepted respondent's Proffer. Based on the record as a whole, the undersigned finds that petitioners are entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, the court awards petitioners:

1. A lump sum payment of $1,507,284.67, representing compensation for life care expenses expected to be incurred during the first year after judgment ($624,713.32), lost future earnings ($674,410.67) and pain and suffering ($208,160.68), in the form of a check payable to petitioners, as the court appointed guardian(s)/conservator(s) of the estate of Child Doe/77, for the benefit of Child Doe/77. No payments shall be made until petitioners provide respondent with documentation establishing that they have been appointed as the guardian(s)/conservator(s) of Child Doe/77's estate;

2. A lump sum payment of $140,109.67, representing compensation for past unreimbursable expenses, payable to John and Jane Doe/77, petitioners;

3. A lump sum payment of $7,821.81, representing compensation for satisfaction of the State of [redacted) Medicaid lien, payable jointly to petitioner and

[redacted) Department of Community Health Subrogation Unit
[redacted)
[redacted)
[redacted)
Attn: [redacted)

4. An amount sufficient to purchase an annuity contract(s), subject to the conditions described in paragraph II. D. of the attached Proffer, paid to the life insurance company(ies) from which the annuity(ies) will be purchased.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith. [3]

IT IS SO ORDERED.

Patricia E. Campbell-Smith
Special Master

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

[DELETE], a minor, by her Parents and Natural Guardians,
Petitioners,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent.

No. [DELETE] V
Special Master
Campbell-Smith

RESPONDENT'S PROFFER ON AWARD OF COMPENSATION

I. Items of Compensation

A. Life Care Items


The respondent engaged life care planners Suzanne Labansky, MSN, CRRN, CCM, CLCP, MSC, and Ginger Walton, MSN, FNP, CNCLP, and petitioners engaged life care planner Terry Kennedy Arnold, RN, CDMS, CRRN, CLCP, CNLCP, to provide an estimation of [DELETE] [DELETE] future vaccine injury-related needs. All items of compensation identified in the life care plan are supported by the evidence and are illustrated by the chart entitled Appendix A: Items of Compensation for [DELETE], attached hereto as Tab A. [1]Respondent proffers that [DELETE] should be awarded all items of compensation set forth in the life care plan and illustrated by the chart attached at Tab A. Petitioners agree.

B. Lost Future Earnings

The parties agree that based upon the evidence of record, [DELETE] will never be gainfully employed. Therefore, respondent proffers that [DELETE] should be awarded full lost future earnings as provided under the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(B). Respondent proffers that the appropriate award for [DELETE] lost future earnings is $674,410.67. Petitioners agree.

C. Pain and Suffering

Respondent proffers that [DELETE] should be awarded $208,160.68 in actual and projected pain and suffering. This amount reflects that the award for projected pain and suffering has been reduced to net present value. Sec 42 U.S.C. § 300aa-15(a)(4). Petitioners agree.

D. Past Unreimbursable Expenses

Evidence supplied by petitioners documents their expenditure of past unreimbursable expenses related to [DELETE] vaccine-related injury. Respondent proffers that petitioners should be awarded past unreimbursable expenses in the amount of $140,109.67. Petitioners agree.

E. Medicaid Lien

Respondent proffers that [DELETE] should be awarded funds to satisfy the State of [DELETE] Medicaid lien in the amount of $7,821.81, which represents full satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the State of [DELETE] may have against any individual as a result of any Medicaid payments the State of [DELETE] has made to or on behalf of [DELETE] from the date of her eligibility for benefits through the date of judgment in this case as a result of her vaccine-related injury suffered on or about July 19, 2000, under Title XIX of the Social Security Act.

II. Form of the Award

The parties recommend that the compensation provided to [DELETE] should be made through a combination of lump sum payments and future annuity payments as described below, and request that the special master's decision and the Court's judgment award the following:

A. A lump sum payment of $1,507,284.67, representing compensation for life care expenses expected to be incurred during the first year after judgment ($624,713.32), lost future earnings ($674,410.67) and pain and suffering ($208,160.68), in the form of a check payable to petitioners, as the court-appointed guardian(s)/conservator(s) of the estate of [DELETE], for the benefit of [DELETE]. No payments shall be made until petitioners provide respondent with documentation establishing that they have been appointed as the guardian(s)/conservator(s) of [DELETE] estate;

B. A lump sum payment of $140,109.67, representing compensation for past unreimbursable expenses, payable to [DELETE], petitioners;

C. A lump sum payment of $7,821.81, representing compensation for satisfaction of the State of [DELETE] Medicaid lien, payable jointly to petitioners and

[DELETE] Department of Community Health
Subrogation Unit
[DELETE]
[DELETE]
[DELETE]
[DELETE]

Petitioners agree to endorse this payment to the State of [DELETE]

D. An amount sufficient to purchase an annuity contract(s), subject to the conditions described below, that will provide payments for the life care items contained in the life care plan, as illustrated by the chart at Tab A attached hereto, paid to the life insurance company(ies) [2] from which the annuity(ies) will be purchased. Compensation for Year Two (beginning on the first anniversary of the date of judgment) and all subsequent years shall be provided through respondent's purchase of an annuity(ies), which annuity(ies) shall make payments directly to petitioners as guardian(s)/conservator(s) of the estate of [DELETE], for the benefit of [DELETE] [DELETE], only so long as [DELETE] is alive at the time a particular payment is due. At the Secretary's sole discretion, the periodic payments may be provided to petitioners in monthly, quarterly, annual or other installments. The "annual amounts" set forth in the chart at Tab A describe only the total yearly sum to be paid to petitioners and do not require that the payment be made in one annual installment.

1. Growth Rate

Respondent proffers that a four percent (4%) growth rate should be applied to all nonmedical life care items, and a five percent (5%) growth rate should be applied to all medical life care items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity payments should grow as follows: four percent (4%) compounded annually from the date of judgment for non-medical items, and five percent (5%) compounded annually from the date of judgment for medical items. Petitioners agree.

2. Life-contingent annuity(ies)

Petitioners will continue to receive the annuity payments from the Life Insurance Company(ies) only so long as [DELETE] is alive at the time that a particular payment is due. Petitioners shall provide written notice to the Secretary of Health and Human Services and the Life Insurance Company(ies) within twenty (20) days of [DELETE] death.

3. Guardianship

No payments under section II. A. shall be made until petitioners provide the Secretary with documentation establishing their appointment as the guardian(s)/conservator(s) of [DELETE] [DELETE] estate. If petitioners are not authorized by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of [DELETE] at the time a payment is to be made, any such payment shall be paid to the party or parties appointed by a court of competent jurisdiction to serve as guardian(s)/conservator(s) of the estate of [DELETE] upon submission of written documentation of such appointment to the Secretary.

III. Summary of Recommended Payments Following Judgment

A. Lump Sum paid to petitioners, as guardian(s)/conservator(s) of the estate of [DELETE] for Yr 1 life care expenses, lost future earnings, and pain and suffering: $1,507,284.67

B. A lump sum paid to petitioners: $140,109.67

C. Reimbursement of the Medicaid lien: $7,821.81

D. An amount sufficient to purchase the annuity contract(s) described above in section II. D.

Respectfully submitted,

TONY WEST
Assistant Attorney General

TIMOTHY P. GARREN
Director
Torts Branch, Civil Division

MARK W. ROGERS
Deputy Director
Torts Branch, Civil Division

CATHARINE E. REEVES
Assistant Director
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044-0146
Telephone: (202) 307-1400

Dated: July 20, 2010

TAB A

Image

Image

Image

Image

Image

Note: Compensation Year 1 consists of the 12 month period following the date of judgment.

Compensation Year 2 consists of the 12 month period commencing nil the first anniversary of the date of judgment. As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed gllardian(s)/custodian(s) of the estate of [DELETE], for the benefit of [DELETE], for lost future earnings ($674.41O.67), pain and suffering ($208,160.68), and Yr 1 life care expenses ($624,713.32): $1,507,284.67.

As soon as practicable after entry of judgment, respondent shall make the following payment to petitioners, [DELETE] and [DELETE] for past un-reimbursable expenses: $140.109.67.

As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioners and the [DELETE] as reimbursement for the state's Medicaid lien: $7,821.81.

Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.

Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment.

Items denoted with an asterisk (*) covered by health insurance and/or Medicare.

Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent.

Image

Image

Image

Image

Image

Note: Compensation Year 1 consists of the 12 month period following the date of judgment.

Compensation Year 2 consists of tile 12 month period commencing on the first anniversary of the date or judgment.

As soon as practicable after entry of judgment shall make the following payment to the court-appointed guardian(s)/custodian(s) of the estate of [DELETE] for the benefit of [DELETE] for lost future earnings {$674.410.67), pain and suffering ($208.160.68), and Yr 1 life care expenses ($624,713.32): $1.507,284.67.

As soon as practicable after entry of judgment, respondent shall make the following payment to petitioners. [DELETE] [DELETE] for past un-reimbursable expenses: $140,109.67.

As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioners and the State of [DELETE] as reimbursement for the state's Medicaid lien: $7,821.81.

Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.

Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment.

Items denoted with an asterisk (*) covered by health insurance and/or Medicare.

Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent.

Image

Image

Image

Image

Image

Note: Compensation Year 1 consists of the 12 month period following the date of judgment.

Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.

As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/custodian(s) of the estate of [DELETE], for the benefit of [DELETE], for lost future earnings ($674,410.67), pain and suffering ($208,160.68), and Yr 1 life care expenses ($624,713.32): $1,507,284.67.

As soon as is practicable after entry of judgment, respondent shall make the following payment to petitioners, [DELETE] and [DELETE] for past un-reimbursable expenses: $140,109.67.

As soon as practicable after entry of judgment, respondent shall make the following payment jointly to petitioners and the State of [DELETE] as reimbursement for the state's Medicaid lien: $7.821.81.

Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.

Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the dale of judgment.

Items denoted with an asterisk (*) covered by health insurance and/or Medicare.

Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent.

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Image

Image

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Note: Compensation Year I consists of the 12 month period following the date of judgment.

Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.

As soon as practicable after entry of judgment, respondent shall make the following payment to the court-appointed guardian(s)/custodian(s) of the estate of [DELETE] for the benefit of [DELETE] for lost future earnings ($674.410.67), pain and suffering ($208,160.68), and Yr 1 life care expenses ($624,713.32): $1,507,284.67.

As soon as is practicable after entry of judgment, respondent shall make the following payment to petitioners, [DELETE] and [DELETE] for past un-reimbursable expenses: $140.109.67.

As soon as practicable after entry of judgment, respondent shall make the following payment jointly to

PETITIONERS and the State of [DELETE] as reimbursement for the state's Medicaid lien: $7,821.81

Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.

Annual amounts shall increase at the rates indicated in column "G.R." above, compounded annually from the date of judgment.

Items denoted with an asterisk (*) covered by health insurance and/or Medicare.

Items denoted with an "M" payable in 12 monthly installments at the discretion of respondent.

_______________

Notes:

1. Vaccine Rule 18(b) provides that all of the decisions of the special masters will be made available to the public unless an issued decision contains trade secrets or commercial or financial information that is privileged or confidential, or the decision contains medical or similar information the disclosure of which clearly would constitute an unwarranted invasion of privacy. When a special master issues a decision or substantive order, the parties have 14 days within which to move for the redaction of privileged or confidential information before the document's public disclosure.

2. The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C.A. § 300aa-10-§ 300aa-34 (West 1991 & Supp. 2002) (Vaccine Act or the Act). All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.

3. Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties' joint filing of notice renouncing the right to seek review.

Notes: RESPONDENT'S PROFFER ON AWARD OF COMPENSATION

1. The chart at Tab A illustrates the annual benefits provided by the life care plan. The annual benefit years run from the date of judgment up to the first anniversary of the date of judgment, and every year thereafter up to the anniversary of the date of judgment.

2. The Life Insurance Company must have a minimum 0[$250,000,000 capital and surplus, exclusive of any mandatory security valuation reserve. The Life Insurance Company must have one of the following ratings from two of the following rating organizations:

a. A.M. Best Company: A++, A+, A+g, A+p, A.+.r, or A+s;

b. Moody's Investor Service Claims Paying Rating: Aa3, Aa2, Aal, or Aaa;

c. Standard and Poor's Corporation Insurer Claims-Paying Ability Rating: AA-. AA. AA+, or AAA;

d. Fitch Credit Rating Company, Insurance Company Claims Paying Ability Rating: AA-. AA. AA+, or AAA.
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 7:15 am

Plaintiff's Original Petition: DR. ANDREW J . WAKEFIELD, MB., BS., FRCS. v. THE BRITISH MEDICAL JOURNAL, a d/b/a of BMJ PUBLISHING GROUP LTD, also d/b/a BMJ GROUP, and BMJ, BRIAN DEER, individually, and DR. FIONA GODLEE, individually.
by Dr. Andrew J. Wakefield, MB., BS., FRCS.
January 12, ___

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.


CAUSE NO. 0-1-GN-12-000003

Filed: 12 January 3 A10:14
Amalia Rodriguez-Mendoza
District Clerk
Travis District
D-1-GN-12-000003

DR. ANDREW J . WAKEFIELD, MB., BS., FRCS.
v.
THE BRITISH MEDICAL JOURNAL, a d/b/a of BMJ PUBLISHING GROUP LTD, also d/b/a BMJ GROUP, and BMJ, BRIAN DEER, individually, and DR. FIONA GODLEE, individually.

IN THE DISTRICT COURT
250TH
FOR THE __ JUDICIAL DISTRICT

TRAVIS COUNTY, TEXAS

PLAINTIFF'S ORIGINAL PETITION

TO THE HONORABLE DISTRICT COURT OF TRAVIS COUNTY:

NOW COMES Plaintiff, Dr. Andrew J. Wakefield, MB., BS., FRCS, and files this Original Petition complaining of Defendants The British Medical Journal a d/b/a of BMJ Publishing Group LTD, also d/b/a BMJ Group and BMJ, Brian Deer, individually, and Dr. Fiona Godlee, individually, and in support thereof would show the Court as follows:

I. DISCOVERY LEVEL

1.1 Discovery in this case shall be conducted under a Level 3 Discovery Control Plan.

II. PARTIES

2.1 Plaintiff, Dr: Andrew J. Wakefield, MB., BS., FRCS. ("Dr. Wakefield") is a resident of Austin, Texas.

2.2 Defendant BMJ Publishing Group LTD which does business as The British Medical Journal, BMJ Gro~IP, and BMJ (hereinafter collectively "BMJ") is a British limited liability company organized under the laws of the United Kingdom that may be served with process pursuant to Section.10(a) of the Hague Convention by serving this Original Petition via international registered mail as follows: BMJ Publishing Group LTD, BMA House, Tavistock Square, London, WCIH 9J,P, United Kingdom. Issuance of Citation for BMJ Publishing Group LTD d/b/a The British Medical Journal, BMJ Group and BMJ is requested at this time.

2.3 Defendant Brian Deer is a citizen and resident of the United Kingdom who may be served with process pursuant to Section 10(a) of the Hague Convention on the Service Abroad of Judicial and Extra-Judicial Documents in Civil and Commercial Matters ("Hague Convention") via international registered mail as follows: Brian Deer, 65 Herne Hill House, Railton Road, London, SE24 OEF, United Kingdom. Issuance of Citation for Brian Deer is requested at this time.

2.4 Defendant Dr. Fiona Godlee is a citizen and resident of the United Kingdom who may be served with process pursuant to Section 10(a) of the Hague Convention via international registered mail as follows: Dr. Fiona Godlee, BMA House, Tavistock Square, London, WCIH 9JP, United Kingdom. Issuance of Citation for Dr. Fiona Godlee is requested at this time.

III. VENUE AND JURISDICTION

3.1 Venue in this defamation lawsuit is mandatory in Travis County, Texas pursuant to TEX. CIV. PRAC. & REM. CODE §15.017, because Travis County was the residence of Plaintiff, Dr. Wakefield, at the time of the accrual of the causes of action alleged herein.

3.2 The amount in controversy is within the jurisdictional range appropriate to this Court's subject matter jurisdiction.

3.3 This Court has personal jurisdiction over the Defendants pursuant to the Texas Long-Arm Statute and consistent with the requirements of Due Process because the Defendants purposefully availed themselves of the privileges, benefits, advantages, and profits of conducting their affairs in the State of Texas by directing a significant and regular flow of publications, including periodicals, journals, articles, subscriptions, and electronic media to institutional and individual residents of this State. Defendants further committed a tort, which is the subject of this suit, in whole or in part, in this State, to wit, authoring, editing, and approving articles and making statements with knowledge or intent that said articles be published and statements be made and directed to residents of this State, including, but not limited to Plaintiff at his residence in Austin, Texas. Said articles, publications and statements contained false and defamatory allegations about Plaintiff Dr. Wakefield and his affairs, business and reputation in the State of Texas as detailed herein.

IV. FACTS

4.1 This defamation lawsuit arises, in part, out of the publication on or about January 5, 2011 and thereafter, in the British Medical Journal, of an article authored for the BMJ by Brian Deer, titled Secrets of the MMR Scare (Exhibit A) and accompanying editorials by the BMJ's editor, Fiona Godlee (Exhibit B 1-2). Defendants' article and editorials, distributed to subscribers in Texas and which form the basis of Plaintiffs claims, contained unfair, incorrect, inaccurate and unjust criticisms of findings previously reported by Dr. Wakefield and 12 other co-authors. More significantly, Defendants accused Dr. Wakefield of fraud and of fraudulently and intentionally manipulating and falsifying data and diagnoses in connection with a clinical paper he co-authored called Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, originally published in the medical journal The Lancet in 1998 (the "Lancet Paper"). Defendants' false and defamatory allegations have been widely disseminated by Defendants through the BMJ and other sources since their original publication.

4.2 In his work for the Lancet Paper, Dr. Wakefield along with twelve other physicians and researchers reviewed twelve cases of sick children presenting pervasive developmental disorders and gastrointestinal symptoms. For the majority of these children, their parents had reported the onset of their respective initial behavioral symptoms in near temporal proximity to each child having received an injection of the Measles, Mumps & Rubella ("MMR") vaccine. In the Lancet Paper, Dr. Wakefield and his colleagues described inflammatory disease in the intestinal lining of these children, possibly related to the MMR vaccine being given all at once. The result of these case studies (a "case series") was documented and summarized in the Lancet Paper that was published in 1998.

4.3 Defendants' article and editorials, published by the BMJ in January 2011, and thereafter, and Defendants' subsequent republication of the information contained therein, and additional defamatory statements, including on Defendant Brian Deer's website and elsewhere, (hereinafter collectively the "Defamatory Statements") charged Dr. Wakefield with intentionally or knowingly manipulating or falsifying data and diagnoses in connection with the findings in the Lancet Paper. These statements against Dr. Wakefield were directed at Dr. Wakefield's activities in Texas, where he now is (and was at the time of the publication of the Defamatory Statements) a resident of Austin, Travis County, Texas. The Defamatory Statements were and are false and written and published with actual malice and intended to cause damage to Dr. Wakefield's reputation and work as a researcher, academic and physician and to permanently impair his reputation and livelihood.

4.4 . The charges made by Defendants that Dr. Wakefield fraudulently and intentionally manipulated or falsified data or diagnoses in the Lancet Paper are false. Purporting to offer a "re-analysis" of the medical records -- many of which Defendants knew were not in the possession of or used by Dr. Wakefield and his colleagues at the time of the publication of the Lancet Paper -- for the twelve subject children, Defendants knowingly and with actual malice misrepresented information, data and diagnoses for the purpose of creating the false impression that it was Dr. Wakefield who had manipulated or altered data or diagnoses. Based on Defendants' purported "reanalysis," Defendants made and continue to make assertions that Plaintiff Dr. Wakefield committed fraud and is "a fraudster."


4.5 On January, 5, 2011, Defendants' published their article, Secrets of the MMR Scare: How the Case Against the MMR Vaccine was Fixed authored by Defendant Brian Deer. (Exhibit A). This article contains numerous false and misleading statements concerning Plaintiff Dr. Wakefield which constitute libel per se and per quod. Examples of the defamatory statements in this article include the following:

• Dr. Wakefield's case study was ''fixed'' and based on "bogus data";

• Dr. Wakefield's findings were "manufactured" to give "the appearance of a link [to] autism";

• Dr. Wakefield's "undisclosed goal" of the project "was to help sue the vaccine's manufacturers" and that "Wakefield evidenced his [new] 'syndrome' for the lawsuit, and built his platform to launch the vaccine scare";

• Deer's self-proclaimed "investigation of the MMR issue exposed the frauds behind Wakefield's research";

• Dr. Wakefield doctored the underlying subjects' data to reach his conclusions as "[n]o case was free of misreporting or alteration";

• The children who were the subjects of the Lancet Paper "were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation"; and,

• Plaintiff Wakefield, "nevertheless, now apparently self-employed and professionally ruined, remains championed by a sad rump of disciples." These statements are false and defamatory.

4.6 Along with the BMJ's publication of Deer's article were equally malicious and defamatory "editorials" by the editor of the BMJ, Defendant Godlee. The first editorial, titled Wakefield's Article Linking MMR Vaccine and Autism was Fraudulent, (Exhibit B-1) was published on the same day as Deer's article. The editorial states: "it has taken the diligent skepticism of [Deer], standing outside medicine and science, to show that the [Lancet Paper] was in fact an elaborate fraud." Godlee goes on to state that Deer's article "shows the extent of Wakefield's fraud and how it was perpetrated ... and how Wakefield altered numerous facts about the patients' medical histories in order to support his claim of having identified a new syndrome." Godlee's libelous rhetoric, including but not limited to the following, is factually inaccurate, malicious, unwarranted and constitutes defamation per se:

"Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children's cases accurately? No." (Exhibit B-1 at p. 2).


The BMJ is supposed to be a respected medical journal, focusing on facts and research. Instead, Godlee, Deer and others at the BMJ used the BMJ to launch an unprecedented personal attack on a doctor who was part of a group of well respected physicians that presented a case study that simply suggested that there might be a connection between the combined MMR vaccine, when administered as a combination of live viruses to certain children, and autism and that suggested further research is warranted.

4.7 Godlee followed with a second editorial called, Editor's Choice: The Fraud Behind the MMR Scare on January 6, 2011. (Exhibit B-2). Likewise false and malicious are the editorial's claims that again parrot the Defendants' earlier groundless assertions. Defendant Godlee's editorial falsely states that, "data had been substantially misrepresented in order to give the result Wakefield needed." Defendants further falsely state that the BMJ had confirmed "extensive falsification" in the Lancet Paper and defamatorily refers to the Lancet case study as Dr. Wakefield's concocted "MMR scare" and falsely states that it was not merely "bad science," but a "deliberate fraud." Similarly false were Godlee's and the BMJ's claims that "in no single case can the medical records be fully reconciled with what was published," by Dr. Wakefield. Additionally, the editorial falsely claims that Dr. Wakefield's findings were not honestly documented which resulted in a "deeply shocking" "breach of trust."

4.8 Interestingly, at the time the editorials and the Deer article were published, the Defendants failed to disclose the fact that the BMJ received significant revenue from the very vaccine manufacturers whose products need further investigation. It was only months later, after the issue was raised by others that the BMJ posted the following: "The BMJ should have declared competing interests in relation to this editorial by Fiona Godlee and colleagues. The BMJ Group receives advertising and sponsorship revenue from vaccine manufacturers, and specifically from Merck and GSK, which both manufacture MMR vaccines." (Exhibit B-3). This statement accompanied the later on-line version of the editorial but was not placed in the on-line version of the Deer article and was not publicized by the BMJ the way the article and editorials were.

4.9 The allegations in Mr. Deer's article, which are summarized and repeated in Godlee's editorials in the BMJ, are based on intentional misrepresentations of the content of the Lancet Paper, with actual malice, for the purpose of falsely stating that the findings referenced in the Lancet Paper were false"and fraudulent and for the purpose of injuring Plaintiff.

4.10 Ironically, the evidence in this case will show that it is Deer, Godlee and BMJ who have provided misleading information regarding these twelve children's histories with the malicious purpose of injuring Dr. Wakefield by falsely making it appear that Dr. Wakefield altered, manipulated or misrepresented data for the twelve cases discussed in the Lancet Paper. In fact, all of the facts and findings in the Lancet Paper are supported by the documents for these twelve patients. Defendants' statement that "[n]o case was free of misreporting or alteration" (Exhibit A p. 5) is false.

4.11 In their publications, the Defendants' mislead the reader to believe that Dr. Wakefield and his co-authors reviewed certain medical records and/or NHS records prior to writing the Lancet Paper, a fact that Defendants knew was false when they made statements stating or implying that Dr. Wakefield had altered or ignored data in records that were not, in fact, in the possession of or used by Dr. Wakefield or his colleagues in writing the Lancet Paper. In actuality, it was the Defendants who misrepresented the data in their "re-analysis" in order to conjure their own conclusions in an effort to defame Dr. Wakefield. However, when the data that underlies the Defendants' conclusions is taken in full-context, it not only confirms the veracity of the Lancet Paper's authors and their findings, but also amplifies the nature of the false and defamatory remarks that Defendants posit about Plaintiff and his character.

4.12 For example, Deer misrepresented the facts of the underlying cases, repeatedly misrepresenting or distorting the content of records for the purpose of falsely accusing Dr. Wakefield of having done precisely what Deer has done. Deer falsely claimed that the records for children 6, 7 and 12 in the Lancet Paper did not have a behavioral diagnosis of autism. Deer states "only one -- child 2 -- clearly had regressive autism. Three of nine so described clearly did not. None of these three even had autism diagnoses, either at admission or on discharge from the Royal Free." (Exhibit A at p. 3). Contrary to Deer's statements (it should be noted that Deer is a journalist and not a medical doctor), based on the clear underlying evidence, these subjects did suffer from autism.

4.13 With regard to child 11 detailed in the Lancet Paper, Deer made several misrepresentations in his efforts to falsely suggest Dr. Wakefield had altered or manipulated data and diagnoses. Deer asserts that symptoms of autism appeared for this child two months earlier than reported in the Lancet Paper and prior to the administration of the MMR vaccine. However, prior to publication of the Lancet Paper, the child's father reported to Dr. Wakefield and his colleagues, and later in person to Deer, (and continues to report) that the child's symptoms did not appear until after receiving the MMR vaccine. Indeed, the child's father has since written Deer and the BMJ to explain that Deer was misrepresenting facts about child 11, yet Deer and BMJ have printed no retraction, correction, or mention of this fact. This failure on Defendants' part is further evidence of their malicious intent to create and foster the false impression that Dr. Wakefield and his colleagues fraudulently altered data and diagnoses for the Lancet Paper.

4.14 Deer asserted in his article that Dr. Wakefield had altered or ignored information from on-duty pathologists as to whether or not the children detailed in the Lancet Paper had intestinal inflammation and specifically, non-specific colitis. However, it was known to the Defendants that the findings of inflammation were based on a blind and systematic analysis of biopsies taken from the children's terminal ileum and large intestine, conducted by an expert pathologist, Dr. Amar Dhillon, and that this analysis was undertaken independently of Dr. Wakefield's involvement in the interpretation of the biopsy findings. Defendants' publications also misleadingly omit that a second independent pathologist, Dr. Andrew Anthony, reviewed the same slides and reached the same conclusions with respect to these children. Dr. Anthony was a medically qualified researcher in the Department of Histopathology at the Royal Free with a published expertise in inflammatory intestinal pathology. And like Dr. Dhillon's review, Dr. Anthony's review was conducted in a blind, unbiased, manner, comparing control slides of normal biopsies, and without the benefit of Dr. Dhillon's grading sheets. This information was deliberately left out of the BMJ publications to create the false impression that Dr. Wakefield had altered the diagnosis for some of the children in the Lancet Paper.

4.15 Deer likewise misrepresented information about the onset of the first behavioral symptoms following administration of the MMR vaccine for several of the children, incompletely reporting on the content of the children's medical records to which Deer had access. He did this for the purpose of creating the impression that Dr. Wakefield had altered or manipulated data. Again, the evidence in this case will show that it was Deer who manipulated the data for the purpose of defaming Dr. Wakefield and that he did so with actual malice. BMJ and Godlee knew that at the time of writing the Lancet Paper, Dr. Wakefield and his colleagues did not use or have in their possession the records used by Deer, however they repeated these false assertions against Dr. Wakefield. In truth, the very records which Defendants' use to allegedly support their own conclusions, actually further confirm the accuracy of the Lancet Paper and Dr. Wakefield's conclusions.

4.16 . Each of the Defamatory Statements which are the subject of this lawsuit are false, known to be false by the Defendants, and were published or stated with actual malice, with the knowledge or intent to harm Dr. Wakefield.

4.17 The BMJ article and editorials were not the end of Defendants' mass propaganda campaign. Within twenty-four hours of Deer and Godlee's initial publications, Defendants were promoting their stories to major print media, radio and television outlets in the United States and in Texas. As noted above, at that time they failed to disclose that the BMJ received advertising and sponsorship revenue from the pharmaceutical companies that manufacture vaccines, including the MMR vaccine.

4.18 On January 6, 2011, Defendant Deer appeared on CNN's American Morning touting his journalistic efforts and again voluntarily offering more false and defamatory statements against Plaintiff Dr. Wakefield.' For example, during his interview on CNN's American Morning, Defendant Deer made the following defamatory remarks concerning Wakefield and his reputation:

• Dr. Wakefield is "a determined cheat";

• Dr. Wakefield embarked in "a campaign of lies"; and,

• Dr. Wakefield is now trying to "work out a nice little living ... at the expense of autistic children."


Defendant Deer stated that "it's not me saying it, it is the editors of that journal [the BMJ] who are behind this." Defendant Deer invited Dr. Wakefield to file a lawsuit against the Defendants stating: "if Wakefield is not 'guilty as charged,' he has the remedy of bringing a libel action against me, against the Sunday Times of London, against the BMJ, against [CNN]." The CNN American Morning show is broadcast in Texas and across the nation.

4.19 The same day Defendant Deer also appeared on CNN's Anderson Cooper 360 Show? In that appearance Defendant Deer reasserted his slanderous remarks against Dr. Wakefield, including the statement that Plaintiff "takes tangential pieces of research that don't really relate to what he is saying and represent them as somehow endorsing what he said." The Anderson Cooper 360 Show is broadcast in Texas and nation-wide.

4.20 On January 25, 2011, Defendant Deer appeared on the radio talk show The Gary Null Show.3 During this talk show, Defendant Deer championed his work and further slandered and defamed Dr. Wakefield stating:

[Wakefield] has been fired by his employers in Austin, Texas. He has now been branded by the British Medical Journal a fraudster. They described his work as an elaborate fraud, and now I think he's consigned to the realms of being a freelance charlatan preying on the parents of autistic children. So I think that sums up my position.


Defendant Deer went on at length parroting his previous false and defamatory remarks concerning Dr. Wakefield, including the statement: "he [Wakefield] went through the results manually altering test results and diagnoses and histories of the children so to create the appearance that there was a link between MMR and autism."

4.21 As early as April 22, 2011, Defendant Deer published a lengthy, self-congratulatory, four-part article called, Nailed: Dr. Andrew Wakefield and the MMR -- autism fraud on the website http://www.briandeer.com.4 This article, published on Deer's website with links to the BMJ article and editorials, contains the following defamatory statements about Dr. Wakefield:

• Dr. Wakefield's work was "a scandal of astounding proportions;"

• Dr. Wakefield's work "had no scientific basis whatsoever";

• Dr. Wakefield's work was a "sham: laundering into medical literature, as apparent facts, the unverified, often vague, memories and assertions of a group of unnamed parents";5

• "Wakefield had repeatedly changed and misreported diagnoses, histories and descriptions of the children, which made it appear that the syndrome had been discovered";

• "The Lancet paper had been rigged"; and,

• "Even when [Wakefield] knew that his allegations had been proven baseless, he was found promoting them from a controversial business in Austin, Texas called Thoughtful House."

Deer made specific reference to the impact of his allegations in Texas stating: "Wakefield was ousted by the directors of his Texas business." Clearly, Deer intends for his defamatory statements to be widely broadcast in the US and is proud of the fact that they have been. He states on his website:

Among hundreds of broadcast and newspaper reports on the BMJ series, which included all north America networks and reached 47% of Americans surveyed in a Harris poll, The New York Times said in an editorial on January 13: "Now the British Medical Journal has taken the extraordinary step of publishing a lengthy report by Brian Deer, the British investigative journalist who first brought the paper's flaws to light -- and has put its own reputation on the line by endorsing his findings."


Defendant Deer's website article contains a host of links and references to national and global media organizations that have cited his story, claiming that "in the United States alone, nearly 145 million people knew of Deer's findings." In particular he references a Washington Post article: "Among the extensive international reportage of the MMR investigation was a long and detailed account in the Washington Post by distinguished journalist, Glenn Frankel. Among his findings was a plan by Wakefield to move his crusade to Texas where, according to one source, his 'entrepreneurial spirit' will find 'fertile ground' in US privatized health care."

4.22 On April 15, 2011, Defendant Deer presented at the Association of Health Care Journalists Annual Conference in Philadelphia, Pennsylvania. At that conference Defendant Deer further defamed Dr. Wakefield. At that conference he slandered Plaintiff Wakefield by stating, among other things, that Dr. Wakefield is "not just incompetent but a fraudster" and by stating that Dr. Wakefield's work is "bullshit."

4.23 In September 2011, Godlee slandered and defamed Dr. Wakefield during a lecture given at the National Institutes of Health ("NIH") in Bethesda, Maryland, which was broadcast nation-wide and is still available on the NIH website.6 For example, in an additional allegation of fraud against Dr. Wakefield, Dr. Godlee referred, in her lecture, to a comparison of the interval between MMR vaccine exposure and "symptoms" in children reported by Dr. Wakefield and his colleagues in two different versions of the Lancet Article, a draft prepared in August 1997 and the final published paper, the Lancet Paper. Dr. Godlee went on to use this allegation as her basis to conclude that Dr. Wakefield fraudulently manipulated the reduction of the time interval in order to create "a legally compelling case which would be a maximum of 14 days and in this case an average of 6.3 days." She not only falsely suggested that Dr. Wakefield fraudulently misreported this medical data, but she imputed to him a malignant intent that he knowingly altered this data in an effort to influence vaccine injury litigation. Both allegations are false and defamatory. In addition Godlee accused Dr. Wakefield of committing "scientific fraud" and a criminal act. These allegations are defamatory per se.

V. DEFAMATION

5.1 Dr. Wakefield hereby brings this common law cause of action libel, slander and defamation against Defendants based on the malicious publication of false claims about Dr. Wakefield as detailed above and incorporated by reference herein.

5.2 Each of the Defendants knowingly misrepresented facts with the purpose of making false accusations against Dr. Wakefield. These false statements were published with actual malice.

5.3 These false claims were known to be false by the Defendants at the time they were made and were made and published with the intent to cause substantial harm to Dr. Wakefield's reputation, to open him up to scorn in his community, and to damage his livelihood.

5.4 The false statements, intended by Defendants to injure Dr. Wakefield in his trade and profession, constitute defamation per se, therefore damages are presumed from the publication of these false statements.

5.5 Alternatively, these statements, intended by Defendants to injure Dr. Wakefield in his trade and profession, constitute defamation per quod.

5.6 The malicious publication of the false statements about Dr. Wakefield detailed above have caused and continue to cause actual general and special damages to Dr. Wakefield, including, injury to character and reputation, humiliation, injury to feelings, and loss of earning capacity.

VI. EXEMPLARY DAMAGES

6.1 Because Defendants acted with actual malice, the Plaintiff is entitled to recover exemplary damages as defined by the Texas Civil Practice & Remedies Code § 43.001, et seq.

VII. DECLARATORY JUDGMENT

7.1 In addition, Plaintiff seeks a declaratory judgment that the Defendants' published false and misleading statements regarding Dr. Wakefield and/or the Lancet Paper.

VIII. PRAYER

Dr. Wakefield hereby prays for a trial by jury as to all disputed issues of fact, and upon findings appropriate, further prays for judgment from this Court against the Defendants for: nominal damages, actual and compensatory damages, special damages, including injury to reputation and character, injury to feelings, humiliation, loss of earning capacity, exemplary damages pursuant to TEX. CIV. PRAC. & REM. CODE §41.001, et. seq., declaratory relief, costs and expenses, prejudgment and post-judgment interest as allowed by law, and for such other and further relief to which he may be justly entitled.

Respectfully submitted,

By:

William M. Parrish
State Bar No. 15540325
bparrish@dpelaw.com
Jay D. Ellwanger
State Bar No. 24036522
John D. Saba Jr.
State Bar No. 24037415

DINOVO PRICE ELLWANGER &
HARDY LLP
7000 North MoPac Expressway,
Suite 350
Austin, Texas 78731
(512) 539-2626 Telephone
(512) 539-2627 Facsimile
ATTORNEYS FOR PLAINTIFF

_______________

Notes:

1 See American Morning, CNN (Jan. 6,2011), available at http://www.cnn.com/2011/HEALTH/01/06/au ... index.html.

2 See Anderson Cooper 360, CNN (Jan. 62011), available at http://ac360.blogs.cnn.coml20l1l01l07/videojournalist- brian-deer-responds-to-dr-andrew-wakefield.

3 See The Gary Null Show, PRN (Jan. 25. 2011), available at http://www.garynull.com.

4 See Brian Deer, Nailed: Dr. A. Wakefield and the MMR - autism fraud, available at http://briandeer.com/mmr/lancet-summary.htm.

5 Deer's article now reads "laundering into medical literature, as apparent facts, the unverified, often vague •• and sometimes altered -- memories and assertions of a group of unnamed parents."

6 See Godlee Lecture (Sept. 6, 2011) available at http://videocast.nih.gov/Summary.asp?File=16828.
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

Postby admin » Sun Feb 28, 2016 7:19 am

APPEAL FROM 250TH DISTRICT COURT OF TRAVIS COUNTY, BEFORE CHIEF JUSTICE JONES, JUSTICES GOODWIN AND FIELD AFFIRMED -- OPINION
BY JUSTICE FIELD
SEPTEMBER 19, 2014

NOTICE: THIS WORK MAY BE PROTECTED BY COPYRIGHT

YOU ARE REQUIRED TO READ THE COPYRIGHT NOTICE AT THIS LINK BEFORE YOU READ THE FOLLOWING WORK, THAT IS AVAILABLE SOLELY FOR PRIVATE STUDY, SCHOLARSHIP OR RESEARCH PURSUANT TO 17 U.S.C. SECTION 107 AND 108. IN THE EVENT THAT THE LIBRARY DETERMINES THAT UNLAWFUL COPYING OF THIS WORK HAS OCCURRED, THE LIBRARY HAS THE RIGHT TO BLOCK THE I.P. ADDRESS AT WHICH THE UNLAWFUL COPYING APPEARED TO HAVE OCCURRED. THANK YOU FOR RESPECTING THE RIGHTS OF COPYRIGHT OWNERS.


TEXAS COURT OF APPEALS, THIRD DISTRICT, AT AUSTIN

JUDGMENT RENDERED SEPTEMBER 19, 2014

NO. 03-12-00576-CV

Dr. Andrew J. Wakefield, MB, BS, Appellant
v.
The British Medical Journal Publishing Group, Ltd.;
Brian Deer; and Dr. Fiona Godlee, Appellees

APPEAL FROM 250TH DISTRICT COURT OF TRAVIS COUNTY
BEFORE CHIEF JUSTICE JONES, JUSTICES GOODWIN AND FIELD
AFFIRMED -- OPINION BY JUSTICE FIELD

This is an appeal from the judgment signed by the trial court on August 3, 2012. Having reviewed the record and the parties’ arguments, the Court holds that there was no reversible error in the trial court’s judgment. Therefore, the Court affirms the trial court’s judgment. The appellant shall pay all costs relating to this appeal, both in this Court and the court below.
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

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Dr Arthur Krigsman -- Autism Associated Enterocolitis. Does my child have it? What Can I Do About It?
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Re: The Vaccine Autism Cover-up: How One Doctor’s Career was

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Part 1 of 2

AMENDED COMPLAINT FOR VIOLATIONS OF THE FEDERAL FALSE CLAIMS ACT
United States of America ex rel., Stephen A. Krahling and Joan A. Wlochowski, Plaintiffs, v. Merck & Co., Defendant.
by Stephen A. Krahling and Joan A. Wlochowski
April 27, 2012

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UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

United States of America ex rel., Stephen A. Krahling and Joan A. Wlochowski, Plaintiffs, v. Merck & Co., Defendant.

Civil Action No. 10 4374 (CDJ)

AMENDED COMPLAINT FOR VIOLATIONS OF THE FEDERAL FALSE CLAIMS ACT

JURY TRIAL DEMANDED

FILED: APRIL 27, 2012

Stephen Krahling and Joan Wlochowski bring this qui tam action as Relators on behalf of the United States against their former employer, Merck & Co., Inc. ("Merck"), under the False Claims Act, 31 U.S.C. §§ 3729-3733, and allege -- upon knowledge with respect to their own acts and those they personally witnessed, and upon information and belief with respect to all other matters -- as follows:

INTRODUCTION

1. This case is about Merck's efforts for more than a decade to defraud the United States through Merck's ongoing scheme to sell the government a mumps vaccine that is mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.

2. Specifically, in an effort to maintain its exclusive license to sell the vaccine and its monopoly of the U.S. market for mumps vaccine, Merck has fraudulently represented and continues to falsely represent in its labeling and elsewhere that its mumps vaccine has an efficacy rate of 95 percent or higher. This is the efficacy rate on which Merck's original government approval for the vaccine was based more than forty years ago. In truth, Merck knows and has taken affirmative steps to conceal -- such as by using improper testing techniques, falsifying test data in a clinical trial, and violating multiple duties of government disclosure -- that the efficacy rate of Merck's mumps vaccine is, and has been since at least 1999, significantly lower than this 95 percent rate.

3. Relators Krahling and Wlochowski were employed as virologists in the Merck lab that performed this fraudulent efficacy testing. They witnessed firsthand the improper testing and data falsification in which Merck engaged to conceal what Merck knew about the vaccine's diminished efficacy. In fact, their Merck superiors and senior Merck management pressured them to participate in the fraud and subsequent cover-up when Relators objected to and tried to stop it.

4. As a result of Merck's fraudulent scheme, the United States has over the last decade paid Merck hundreds of millions of dollars for a vaccine that does not provide the efficacy Merck claims it provides and does not provide the public with adequate immunization. Had Merck complied with its multiple duties of disclosure and reported what it knew of the vaccine's diminished efficacy -- rather than engage in fraud and concealment -- that information would have affected (or surely had the potential to affect, which is all the law requires) the government's decision to purchase the vaccine. However, since the government was not fully informed, it did not have the opportunity to consider its options, including not purchasing the vaccine from Merck, paying less, requiring a labeling change, requiring additional testing, or prioritizing development and approval of a new vaccine from Merck or another manufacturer.

5. Merck's failure to disclose what it knew about the diminished efficacy of its mumps vaccine has caused the government to purchase mislabeled, misbranded, adulterated and falsely certified vaccines in violation of Merck's contact with the Centers for Disease Control ("CDC") and in violation of the law.

6. As the single largest purchaser of childhood vaccines (accounting for more than 50 percent of all vaccine purchases), the United States is by far the largest financial victim of Merck's fraud. But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection against mumps. And while this is a disease the CDC targeted to eradicate by now, the failure in Merck's vaccine has allowed this disease to linger with significant outbreaks continuing to occur.

7. Relators bring this case on behalf of the United States to recover the funds that the government spent for this fraudulently mislabeled, misbranded, adulterated and falsely certified vaccine; and for all associated penalties. They also bring this case to stop Merck from continuing with its scheme to misrepresent the true efficacy of its mumps vaccine and require Merck to comply with its reporting, labeling and testing obligations under its contract with the CDC and under this country's vaccine regulatory regime.

PARTIES

8. Relator Stephen A. Krahling is a citizen of the United States and a resident of Pennsylvania. He was employed by Merck from 1999 to 2001 as a virologist in Merck's vaccine division located in West Point, Pennsylvania. During his employment at Merck, Krahling witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck's mumps vaccine.

9. Relator Joan Wlochowski is a citizen of the United States and a resident of Connecticut. She was employed by Merck from January 2001 to August 2002 as a virologist in Merck's vaccine division in West Point, Pennsylvania. During her employment there, Wlochowski also witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck's mumps vaccine.

10. Defendant Merck is headquartered in New Jersey with its vaccine division based in West Point, Pennsylvania. Merck is one of the largest pharmaceutical companies in the world with annual revenues exceeding $20 billion. Merck is also a leading seller of childhood vaccines and currently markets in the U.S. vaccines for 12 of the 17 diseases for which the CDC currently recommends vaccination.

11. Merck is the sole manufacturer licensed by the Food and Drug Administration ("FDA") to sell mumps vaccine in the United States. Merck's mumps vaccine, together with Merck's vaccines against measles and rubella are sold as MMRII. Merck annually sells more than 7.6 billion doses of the vaccine in the U.S. for which it derives hundreds of millions of dollars of revenue. The U.S. purchases approximately 5 million of these doses annually. Merck also has a license in the U.S. to sell ProQuad, a quadravalent vaccine containing MMRII vaccine and chickenpox vaccine. Under a license from the European Medicines Agency ("EMA"), Merck also sells mumps vaccine in Europe as a part of the trivalent MMRVaxpro and the quadravelent ProQuad through Sanofi Pasteur MSD, a joint venture with the vaccine division of the Sanofi Aventis Group. ProQuad has been sold intermittently in the U.S. and Europe from its approval in 2005 and 2010.

JURISDICTION AND VENUE

12. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. § 1331 and 31 U.S.C. § 3732(a).

13. This Court has personal jurisdiction over Merck under 28 U.S.C. § 1391(b) and 31 U.S.C. § 3732(a) because a substantial part of the events giving rise to this Complaint occurred in this District. Indeed, Merck's fraudulent scheme with respect to its mumps vaccine was originated and continues to be carried out in this District at Merck's vaccine division facility in West Point, Pennsylvania.

14. Pursuant to 31 U.S.C. § 3732(a), venue is proper because Merck can be found in and transacts business within this District. Throughout the time period relevant to the allegations of this Complaint, Merck engaged in substantial business transactions within this District and committed many of the violations proscribed by 31 U.S.C. § 3729 in this District.

BACKGROUND

15. For more than forty years, Merck has had a de-facto exclusive license from the federal government to manufacture and sell a mumps vaccine in the U.S.

16. Merck first obtained approval for the vaccine in 1967 from the Department of Biologics Standards of the National Institute of Health ("DBS"), the agency at the time responsible for licensing vaccines. The vaccine was developed by Dr. Maurice Hilleman, at Merck's West Point research facility, from the mumps virus that infected his five-year-old daughter Jeryl Lynn. Merck continues to this this "Jeryl Lynn" strain of the virus for its vaccine today.

17. Merck's original mumps vaccine was delivered to patients in a single, stand-alone injection called Mumpsvax. In 1971, Merck developed a combination vaccine which delivered Merck's vaccines for measles, mumps and rubella ("MMR") together in one injection. The same year, Merck obtained DBS approval to manufacture and sell MMR vaccine. In 1978, Merck obtained approval from the FDA (which succeeded the DBS as the agency responsible for licensing vaccines) for the manufacture and sale of MMRII, a replacement for MMR containing a different strain of the rubella virus. Since that time, Merck has sold more than 450 million does of MMRII world-wide, with approximately 200 million doses sold in the U.S.

18. In September 2005, Merck obtained FDA approval for ProQuad. [1] Merck sold ProQuad in the U.S. from its approval in 2005 until June, 2007. According to Merck, the vaccine became unavailable because of certain manufacturing constraints. The vaccine was briefly available again in 2010 but has not been available since then.

19. In order to obtain its original government approval to sell its mumps vaccine, Merck conducted field studies of vaccinated children and concluded that the vaccine had an efficacy rate of 95 percent or higher. This meant that 95 percent of those given the vaccine were considered immunized against mumps. This is important because when an adequate number of people have immunity, the changes of an outbreak are reduced, and -- ultimately -- eliminated. If there is insufficient immunity, a real risk of continued disease outbreaks exists. When mumps outbreaks occur in vaccinated populations, it afflicts older children who are at greater risk of serious complications.

20. Before the introduction of the vaccine, there were approximately 200,000 cases of mumps in the U.S. annually. This number dropped off precipitously after the widespread administration of Merck's vaccine. The CDC projected that, by 2010, mumps could be completely eradicated. Unfortunately, that has not happened. Beginning in 2006, there has been a resurgence in mumps outbreaks.

21. Merck predicted the resurgence of outbreaks given the diminished effectiveness of its mumps vaccine. While Merck obtained its original license in 1967 stating that its vaccine was at least 95 percent effective, Merck knows that the vaccine's efficacy is significantly less than that now. Merck knows that the continued passaging of the attentuated virus to make more vaccine for distribution has altered the virus and has degraded the efficacy of the product.

22. Rather than develop a new mumps vaccine with greater efficacy, or permit other manufacturers to enter the U.S. market with a competing vaccine, Merck has instead taken pains to preserve its exclusive U.S. license by maintaining before the government and the public that its more than forty-year-old vaccine continues to have an efficacy rate of 95 percent or higher. This was easy to do for a while because Merck was able to refer back to the efficacy testing it conducted in connection with the government's original granting of Merck's license to sell the mumps vaccine. However, beginning in the late 1990s, Merck initiated new efficacy testing of its mumps vaccine. This testing coincided with an application to change the MMRII labeling in the U.S. and an application for a license to sell MMRII in Europe. This testing also coincided with Merck's development and quest for approval of ProQuad in both the U.S. and Europe.

23. Without demonstrating that its mumps vaccine continued to be 95 percent effective, Merck risked losing the monopoly it had over the sale of mumps vaccine in the U.S. With respect to MMRII or Mumpsvax, the government might have negotiated to pay less for the vaccine, required a labeling change, or required additional testing. Or, the government might have stopped purchasing Merck's vaccine altogether as the door would be open to new manufacturers to enter the market. With respect to ProQuad, the government might not have approved the vaccine at all. Under any of these scenarios, Merck risked losing hundreds of millions of dollars in revenue from this very profitable enterprise.

24. So, Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. In performing this testing, Merck's objective was to report efficacy of 95 percent or higher regardless of the vaccine's true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. Relators Krahling and Wlochowski participated in the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.

MERCK'S FRAUD IN TESTING THE EFFICACY OF ITS MUMPS VACCINE

A. Merck's Abandonment of Its Original PRN Test and Test Results.

25. The original methodology Merck employed under Protocol 007 was a Mumps Plaque Reduction Neutralization ("PRN") Assay. Preliminary testing commenced in 1999 at Merck's West Point facility and was led by Senior Investigator David Krah and his second in command, Mary Yagodich. Merck's Executive Director of Vaccine Research, Alan Shaw, approved the testing methodology Krah and Yagodich employed. Relator Krahling witnessed Krah and Yagodich as they conducted the preliminary testing.

26. As the name of the test indicates, the PRN test measures the virus neutralization that occurs after administration of the mumps vaccine. Merck's test was in some measure similar to the testing procedure regarded in the scientific community as the "gold standard" for testing how well a vaccine works. Blood samples are taken from children both before they receive the vaccine and again after they have been injected with the vaccine (after sufficient time has passed for the vaccine to produce an immune response). The paired blood samples are then individually incubated with the target virus and added to sheets of cells. Where the virus replicates in the cell sheest it leaves a plaque, or hole.

27.The pro-vaccinated child will not typically have immunity to the disease. Therefore, the pre-vaccinated blood will be unable to neutralize the virus and plaques will form where the virus has infected the cells. In contrast, if the vaccine has stimulated the child's immune system to develop antibodies against the virus, the post-vaccinated blood will neutralize the virus. The post-vaccinated blood sample will consequently show a smaller number of plaques, or holes, in the cell sheet compared to the pre-vaccinated sample.

28. A PRN test simply compares virus growth in the presence of the pre- and post-vaccinated blood samples. The number of plaques (where the virus has grown) is compared to determine if the vaccine caused the child to develop a sufficient level of antibodies to neutralize the virus. Results are reported in terms of seroconversion. A seroconversion occurs when the pre-vaccination blood sample is "negative" (meaning, insufficient antibodies to neutralize the virus) and the post-vaccinatation sample is "positive" (meaning, sufficient antibodies to neutralize the virus). Seroconversion occurs, therefore, when a blood sample goes from "pre-negative" (insufficient antibodies) to "post-positive" (sufficient antibodies). Seroconversion in the lab is the best correlate for efficacy -- how the vaccine works at successfully immunizing children. For the purposes of its testing, Merck was looking for a seroconversion rate of 95 percent or higher to support its original efficacy finding and the efficacy it continued to represent in its labeling.

29. While Merck's PRN test was modeled after the neutralizing test generally accepted in the industry, it diverged from this "gold standard" test in a significant way. It did not test the vaccine for its ability to protect against a wild-type mumps virus. A wild-type virus is a disease-causing virus, a strain of the virus as it exists in nature and would confront a person in the real world. That is the type of real-life virus against which vaccines are generally tested. Instead, Merck tested the children's blood for its capacity to neutralize the attenuated Jeryl Lynn virus. This was the same mumps strain with which the children were vaccinated. The use of the attenuated Jeryl Lynn strain, as opposed to a virulent wild-type strain, subverted the fundamental purpose of the PRN test which was to measure the vaccine's ability to provide protection against a disease-causing mumps virus that a child would actually face in real life. The end result of this deviation from the accepted PRN gold standard test was that Merck's test overstated teh vaccine's effectiveness.

30. Even with a deviation that could only overstate how well the vaccine worked, the results from Merck's preliminary testing (which involved testing blood samples of approximately 60-100 children) yielded serconversion rates significantly below the desired 95 percent threshold. Krah admitted as much to Relator Krahling. He also admitted that the efficacy of Merck's vaccine had declined over time, explaining that the constant passaging of virus to make more vaccine for distribution had degrated the product and that because of this, mumps outbreaks would increase over time.

31. Krah further admitted to Krahling that he and Yagodich tried numerous other, often undocumented, techniques to modify the PRN test in order to improve the seroconversion results they could measure, including trying different virus dilutions, different staining procedures and even counting plaques more liberally. These other techniques -- like using the vaccine strain rather than the wild-type strain of the virus -- subverted the purpose of the PRN test. In the end, however, none of it mattered. Merck had to abandon its methodology because no matter how Krah and Yagodich manipulated the procedures, they could not reach the 95 percent seroconversion threshold.

32. So, Merck abandoned the PRN methodolgy that yielded unsatisfactory results and worked towards developing a new, rigged methodology that would allow Merck to report is desired seroconversion results.

B. Merck's Improper Use of Animal Antibodies In Its "Enhanced" PRN Test

33. The new methodology Merck devised and ultimately used to perform the mumps efficacy testing under Protocol 007 was an Enhanced Mumps Plaque Reduction Neutralization Assay. It was again led by Krah and approved by Shaw and commenced in 2000. Relators Krahling and Wlochowski participated on the team that conducted the testing using this supposedly enhanced methodology. Each of them witnessed firsthand the falsification of the test data in which Merck engaged to reach its 95 percent seroconversion threshold. In fact, each was significantly pressured by Krah and other senior Merck personnel to participate in this fraud.

34. From the outset, Merck's objective with this "enhanced" procedure was clear. It was not to measure the actual seroconversion rate of Merck's mumps vaccine. It was to come up with a methodology that would yield a minumum 95 percent seroconversion rate regardless of the vaccine's true efficacy. The very first page of an October 2000 Merck presentation on the "enhanced" methodology stated just that:

Objective: Identify a mumps neutralization assay format ... that permits measurement of a ≥95% seroconversion rate in MMR®II vaccines.

Notably, nowhere in this presentation did Merck provide any kind of justification or explanation for abandoning its original PRN methodology and the unsatisfactory seroconversion results it yielded.

35. To reach the stated objective for its "enhanced" test and increase the measured seroconversion rate to the predetermined 95 percent threshold, Merck continued to use its scientifically flawed PRN methodology -- that tested against the vaccine strain rather than the wild-type strain -- but with one additional material change. Merck added animal antibodies to both the pre and post-vaccination blood samples. The use of animal antibodies in laboratory testing is not uncommon. They can serve as a highlighter of sorts to identify and count human antibodies that otherwise might not be identifiable on their own. When used in that way, animal antibodies make it easier to see the human antibodies. They do not alter what is being measured. However, Merck added animal antibodies for the singular purpose of altering the outcome of the test by boosting the amount of virus neutralization counted in the lab.

36. In a laboratory setting, animal antibodies can combine with human antibodies to cause virus neutralization that would not otherwise occur from the human antibodies alone. Merck's "enhanced" methodology permitted various types of human antibodies to be counted as mumps neutralizing antibodies when it was actually the animal antibodies combining with those human antibodies causing the neutralization. Merck also did not apply a proper "control" to isolate whether virus neutralization was caused by the human antibodies alone or in combination with the animal antibodies. Rather, Merck included in its seroconversion measure all virus neutralizations regardless of whether they resulted from human antibodies or by their combination with the animal antibodies. This "enhanced" PRN methodology thereby allowed Merck to increase dramatically the recordable instances of mumps virus neutralization and to count those neutralizations toward seroconversion and its measure of the vaccine's success.

37. Merck knew that the neutralizations attributable to the animal antibodies would never exist in the real world. This is because the human immune system, even with the immunity boost provided by an effective vaccine, could never produce animal antibodies. And adding this external factor as a supplement to a vaccine was not an option because it could result in serious complications to a human, even death. Thus, the "uncontrolled" boost to neutralization Merck designed using these animal antibodies in its laboratory did not in any way correspond to, correlate with, or represent real-life (in vivo) virus neutralization in vaccinated people.

38. But the use of the animal antibodies allowed Merck to achieve its high serconversion objectives. In fact, paired blood samples that were found under Merck's 1999 PRN methodology to lack sufficient virus neutralizing antibodies were now considered seroconverted using the "enhanced" methodology. Indeed, in one panel of sixty paired blood samples, Merck measured a seroconversion rate of 100 percent. In other words, non-neutralizing concentrations of antibodies that would never protect a child from mumps in the real world were, under Merck's "enhanced" methodology, treated as vaccine successful solely because of the additional neutralization provided by the animal antibodies.

39. Krah defended the use of the animal antibodies in the "enhanced" PRN test by pointing to the FDA's purported approval of the process. However, whatever FDA approval Merck may have received for this testing, the FDA was not fully aware of the extent of Merck's manipulation of the testing, including Merck's wholesale fabrication of test data to reach its preordained 95 percent efficacy threshold.

C. Merck's Falsification of the "Enhanced" PRN Test Results

40. There was one significant problem with Merck's improper use of the animal antibodies to boost its virus neutralization counts which would be evident to any scientist reviewing the test data. The animal antibodies boosted neutralization counts not only in the post-vaccination blood samples. They also boosted neutralization counts in the pre-vaccination samples. However, too much virus neutralization in the pre-vaccinated sample created a "pre-positive," which means enough virus neutralization to characterize the child as immune without the vaccine.

41. Pre-positives ordinary occur in a small percentage of the child population that is immune to mumps even without vaccination. This immunity would principally come from a previous exposure to the mumps virus, or from immunity transferred to a child from the mother in utero. However, the incidence of this immunity is small, generally measured by the scientific community at around 10 percent of the child population.

42. The problem for Merck was that with the addition of the animal antibodies to the pre-vaccination blood samples it was seeing a significantly higher percentage of pre-positives than the 10 percent industry recognized occurrence of such immunity. In the results of one test that Relators Krahling and Wlochowski both witnessed in the summer of 2001, the pre-positive rat was more than 80 percent. Krah instructed Wlochowski to throw out the results and the actual experimental plates of that particular test thereby destroying all traces of the unwanted results.

43. The existence of such a high percentage of pre-positives threatened the viability of Merck's "enhanced" methodology. As a practical matter, with a pre-positive, any favorable results in the post-vaccinated sample could not be counted as a vaccine success toward the 95 percent efficacy target. A sample appearing positive before the vaccine, and staying positive after the vaccine, was not a seroconversion.

44. Just as important, the high pre-positive rate would red flag the methodology as flawed. The FDA would question the results of a test that had such a high level of pre-positives. Krah stated this explicitly to the members of his lab, including Relators Krahling and Wlochowski. If Merck wanted to keep the artificial boost in post-vaccination positives provided by the animal antibodies, it would have to eliminate the associated boost in pre-vaccination positives.

45. In the October 2000 presentation, Merck acknowledged that its initial "enhanced" PRN testing results yielded a level of pre-positives that was too high. Merck also made clear that it needed to "optimize" the amount of animal antibodies used in the process so that the testing would yield a pre-positive rate of 10 percent or less and a seroconversion rate of 95 percent or more: "Pre-positive rate is higher than desirable," and "Continue evaluation of results using optimized [animal antibodies] amount (target ˂ 10Q% pre-positive rate and ≥ 95Q% seroconversions)."

46. The problem was that no amount of tinkering with the amount of animal antibodies added would produce a pre and post-vaccination virus neutralization for Merck's vaccine within the desired range. Without the animal antibodies, Merck could not support a sufficient level of post-vaccination neutralization. Conversely, by adding the animal antibodies, Merck could not avoid having too high a level of pre-vaccination neutralization (i.e., too many pre-positives). This left only one way for Merck to reach its desired seroconversion outcome -- falsify the test results.

47. Specifically, Krah and Yagodich and other members of Krah's staff falsified the test results to ensure a pre-positive neutralization rate of below 10 percent. They did this by fabricating their plaque counts on the pre-vaccination blood samples, counting plaques that were not actually there. With these inflated plaque counts, Merck was able to count as pre-negative those blood samples that otherwise would have been counted as pre-positive because of the increased neutralization caused by the animal antibodies.

48. Merck's falsification of the pre-vaccination plaque counts was performed in a broad-based and systematic manner from December 2000 until at least August 2001:

• Krah stressed to his staff that the high number of pre-positives they were finding was a problem that needed to be fixed.

• Krah directed his staff to re-check any sample found to be pre-positive to see if more plaques could be found to convert the same to a pre-negative.

• Krah and Yagodich falsified plaque counts to convert pre-positives to pre-negatives, and directed other staff scientists to do the same.

• Krah appointed Yagodich and two others to "audit" the testing that other staff scientists had performed. These audits were limited to finding additional plaques on pre-positive samples thereby rendering them pre-negatives.

• Krah instituted several measures to isolate the pre-positive samples, facilitate their "re-count" and consequent conversion to pre-negatives. For example, when manually changing original counting sheets proved too time-consuming, Krah employed an excel spreadsheest which would automatically highlight the undesirable pre-positives so that they could be targeted more efficiently. The data was entered, highlighted and changed before it was ever saved.

• Krah also engaged in the destruction of the evidence to minimize the chances of detection. He not only employed the excel spreadsheest which left no paper trail. He also destroyed test results, substituted original counting sheets with "clean" sheets, and ordered the staff in the lab to do the same.

• Merck cancelled (in March 2001) a planned outsource of the testing to a lab in Ohio because the outside lab was unable to replicate the seroconversion results Krah was obtaining in his lab. Krah and his staff conducted all the remaining testing instead.

49. Unsurprisingly, none of the "recounting" and "retesting" that Krah and his staff performed as part of the "enhanced" testing was performed on any post-vaccination samples or on any pre-vaccination samples that were pre-negative. This additional "rigor" was only applied to the pre-positive samples, the very samples Merck had identified as undesirable and which kept Merck from attaining its target of ≤ 10% pre-positive rate and ≥ 95% seroconversion.

50. Relators Krahling and Wlochowski engagfed in numerous efforts to stop the fraud. They questioned and complained to Krah about the methodology being employed, particularly the manipulation of pre-positive data. They attempted to dissuade others from participating. They initiated numerous calls to the FDA to expose the fraud. And they attempted to document the fraud, even as evidence of it was being destroyed. But Relators' efforts were to no avail. For every effort they took to stop the fraud, Merck adapted the scheme to assure the falsification continued. For example, when Relators objected to changing their own plaque counts, Krah appointed other staff, as so-called auditors, willing to falsify the data.

51. In July 2001, Relators Krahling and Wlochowski secretly conducted their own audit of the test results to confirm statistically the fraud that was occurring with the "enhanced" testing. They reviewed approximately 20 percent of the data that Merck had collected as part of the "enhanced" test. In this sampling, they found that 45 percent of the pre-positive data had been altered to make it pre-negative. No pre-negatives were changed to pre-positives. No post-positives were changed to post-negatives. No post-negatives were changed to post-positives. All changes were in one direction -- reducing the incidence of pre-positives. The statistical probability of so many changes occurring in just the pre-positive data and in no other data was more than a trillion to one. And that is a conservative measure given the likelihood that an even greater number of pre-positives were changed but remained undetected because the changes were not recorded in Merck's files.

D. The Complicity of Merck's Senior Management

52. Krah did not act alone in orchestrating the falsification of the "enhanced" PRN test results. He acted with the authority and approval of Merck's senior management.

53. For example, in April 2001, after Merck cancelled the planned outsourcing of the remainder of the mumps efficacy testing, Emilio Emini, the Vice President of Merck's Vaccine Research Division, held a meeting with Krah and his staff, including Relators Krahling and Wlochowski. Emini was clearly on notice of protests that had been going on in the lab because he directed Krah's staff to follow Krah's orders to ensure the "enhanced" testing would be successful. He also told the staff that they had earned very large bonuses for the work they had completed on the project so far and that he was going to double the bonuses and pay them once the testing was complete.

54. In July 2001, after completing the secret audit, Relator Wlochowski openly accused Krah during a lab meeting of committing fraud in the mumps testing. Relator Krahling then met with Alan Shaw, the Executive Director of Vaccine Research and confronted him about the fraudulent testing. Krahling told Shaw of the falsification of the pre-positive data. He also confronted Shaw about the improper use of the animal antibodies to inflate the post-vaccine neutralization counts. Shaw responded that the FDA permitted the use of the animal antibodies and that should be good enough for Krahling. Shaw refused to discuss anything further about the matter. Instead, Shaw talked about the significant bonuses that Emini had promised to pay the staff in Krah's lab once the testing was complete.

55. Relator Krahling then met with a Bob Suter, Krahling's human resources representative at Merck. Krahling told Suter about the falsification of data and Shaw's refusal to get involved. Krahling told Suter that he was going to report the activity to the FDA. Suter told him he would go to jail if he contacted the FDA and offered to set up a private meeting with Emini where Krahling could discuss his concerns.

56. Shortly thereafter, Emini agreed to meet with Krahling. In the early August, 2001 meeting with Emini, Krahling brought actual testing samples and plaque counting sheets to demonstrate to Emini the fraudulent testing that Krah was directing. Emini agreed that Krah had falsified the data. Krahling also protested against the use of the animal antibodies to inflate the seroconversion rate. Emini responded that the animal antibodies were necessary for Merck to achieve the project's objective. Krahling proposed a scientific solution to lower the pre-positive rate and end the need to falsify data -- stop using the animal antibodies. When Emini declined, Krahling asked him what scientific rationale justified using the animal antibodies. Emini explained that Merck's choice to use the antibodies was a "business decision."

57. To assuage Krahling concerns, Emini promised to conduct an "internal audit" of the mumps testing. Krahling countered that the FDA should be contacted since only the FDA could perform an audit that was truly independent. Emini ordered Krahling not to call the FDA. Immediately after the meeting, Suter approached Krahling, and again threatened that he would be put in jail if he contacted the FDA.

58. The next morning, Krah arrived early to the lab and packed up and destroyed evidence of the ongoing mumps testing. This evidence included garbage bags full of the completed experimental plates, containing the cell sheets with plaques, that would have (and should have) been maintained for review until the testing was complete and final. The destruction of the plates would make it difficult to compare the actual plaque counts in the test with what was documented and changed on the counting sheets, as Krahling had done the day before in Emini's office. Despite the threats he received from Suter and Emini, Krahling called the FDA again and reported this latest activity in Merck's ongoing fraud.

E. The FDA Interview of Krah and Shaw

59. On August 6, 2001, in response to Relator Krahling's repeated calls, an FDA agent came to Merck to question Krah and Shaw. The FDA agent's questions were largely focused on Merck's process for counting plaques in the "enhanced" PRN test. Krah and Shaw misrepresented the process that Merck was actually conducting and the fact that Merck was falsifying the pre-positive test data.

60. For example, the FDA agent asked whether there was any ad hoc revisiting of plaque counts. Krah falsely responded that plaque counts were being rechecked only for verification, controls and to check hypervariability. Krah also misrepresented to the FDA that they did not change the data after it was entered in the excel workbook. When the FDA agent pressed Krah on the criteria for changing original counts on the counting sheets, Krah left the interview without answering the question. In Krah's absence, Shaw informed the FDA agent that a memo would be added to the standard operating procedure to address changes. The FDA agent then asked Shaw why they had not taken care of this before the project started. Shaw offered that Krah and another Merck employee had identified "trends" and "problems" with the original counts without ever explaining what those "trends" or "problems" actually were.

61. The interview proceeded in this manner with Shaw and Krah obfuscating what was happening in the lab and obstructing the FDA's efforts to find out what was really going on with Merck's manipulation of the testing procedure to reach its targeted seroconversion rate.

62. The entire interview with Krah and Shaw was short, probably less than half an hour. The FDA agent did not question Relators Krahling or Wlochowski or other members of Krah's staff in or5der to corroborate what Krah and Shaw said. As far as Relators witnessed, the FDA agent did not attempt to substantiate Krah's or Shaw's responses by reviewing any of the testing samples or backup data that had escaped destruction. And the FDA agent did not address the actual destruction of evidence that Krah had already facilitated.

63. The FDA issued a one page deficiency report identifying a few relatively minor shortcomings in Merck's testing process. These principally related to flaws in Merck's recordkeeping and in its validation/explanation of changes to the test data.

64. The report did not address or censure Merck for any issues relating to Merck's improper use of the animal antibodies or Merck's wide-scale falsification of pre-positive test data. The FDA did not discover this fraudulent activity in the course of the perfunctory visit because of Krah's and Shaw's misrepresentations to the FDA.

F. Merck's Completion and Use of the Fraudulent Test Results

65. In order to comply with the FDA's deficiency report, Merck made minor adjustments to its testing procedure relating to its heretofore ad hoc procedure for counting plaques. The new, more formalized procedure explicitly provided for supervisory oversight and review of plaque counts in pre-vaccinated blood samples and where plaques were difficult to read because of the condition of the sample. In other words, under the "new" procedure, Merck continued to falsify the test data to minimize the level of pre-positives and inflate the seroconversion rate.

66. After the FDA visit, Relator Krahling was barred from any further participation in the Protocol 007 mumps vaccine testing project. He was also prohibited from accessing any data related to the project. Shortly thereafter, he was given a poor performance review and barred from continuing to work in Krah's lab on any matter. He was offered a position in a different lab within Merck's vaccine division, but it involved work for which Krahling had no prior experience or interest. In December, 2001 Krahling resigned from the company.

67. Relator Wlochowski continued to work at Merck, though she was transferred out of Krah's lab at the end of September, 2001. She spent an additional year working at Merck in a different lab before she too left Merck.

68. Before Relators Krahling and Wlochowski left Krah's lab, Merck conducted the internal audit Emini had promised Relator Krahling would take place. However, as Krahling had warned against, the audit was anything but independent. Unsurprisingly, therefore, Merck completed its Protocol 007 testing in late summer or early fall 2001 and Merck reported the 95 percent seroconversion it had targeted from the outset. What no one knew outside of Merck -- not the FDA, the CDC or any other governmental agency -- was that this result was the product of Merck's improper use of animal antibodies and the wide-scale falsification of test data to conceal the significantly diminished efficacy of its vaccine.

69. Notably, while Relators Krahling and Wlochowski were immediately removed from Krah's lab for their protests against and efforts to stop the fraudulent testing, those that facilitated the fraud remained. Indeed, Krah, Yagodich and other members of Krah's staff who were instrumental in the fraud continue to work in vaccine development at Merck today and are still working together in Krah's lab.

MERCK'S ONGOING FRAUDULENT REPRESENTATION OF A 95 PERCENT EFFICACY RATE

70. Since at least the beginning of the Protocol 007 testing and continuing through the present, Merck has falsely represented to the government and the public that its mumps vaccine has at least a 95 percent efficacy rate. It has done so even though Merck is well aware, and has taken active steps to keep secret, that the efficacy rate is far lower.

A. Merck's False Representations Through Package Inserts

71. Merck principally has made these false representations in the package insert or labeling that accompanies each dose of Merck's vaccine. This is the product material that the law requires which, among other things, informs the government, health care providers and the public of the composition of the vaccine and its overall efficacy at immunizing the recipient from contracting mumps.

72. Merck's mumps vaccine insert has changed over the years, but at least one thing has remained constant -- Merck's reporting of at least a 95 percent efficacy rate. The current package insert for MMRII provides that "a single injection of the vaccine induced ... mumps neutralizing antibodies in 96% ... of susceptible persons." Merck neither identifies the study performed or the date it was performed that supposedly support this representation. The current insert further provides that: "Efficacy of measles, mumps and rubella vaccines was established in a series of double-blind controlled field trials which demonstrated a high degree of protective efficacy afforded by the individual vaccine components." As support for this representation, Merck, cites the more than forty-year-old studies it conducted to obtain the original governmental approval for a mumps vaccine in 1967. Merck's MMRII package insert has contained this language and "support" since at least 1999.

73. Merck's product insert is a clear misrepresentation of the efficacy rate of its mumps vaccine. It cites outdated or unidentified studies that are not reflective of what Merck knows now about the vaccine's current effectiveness as confirmed by Merck's efforts to manipulate the methodology and ultimately falsify the data to report at least 95 percent seroconversion. In short, as Merck well knows, the efficacy rate of its mumps vaccine is not anywhere near 95 percent. Yet, Merck continues to falsely represent a 95 percent efficacy rate to ensure its continued lock on the sale of the vaccine in the U.S.

B. Merck's False Representations Through Expanded Distribution of the Vaccine

74. Merck's misrepresentations relating to its mumps vaccine have not been made just to the U.S. government for MMRII. Merck has also obtained approval to sell MMRII in Europe and to sell ProQuad in the U.S. and Europe. Merck obtained these approvals by again misrepresenting to the FDA (in the U.S.) and the EMA (in Europe) the efficacy rate of its mumps vaccine.

75. In 2004 Merck submitted an application to the FDA for approval of ProQuad. Merck certified the contents of its application were true. In 2005, after reviewing Merck's application, the FDA approved ProQuad. According to the FDA's clinical review of the studies Merck submitted in support of ProQuad, "[c]linical efficacy of ... mumps ... vaccine strain w[as] shown previously ... using [the] monovalent. [T]he vaccine response rates were 95.8 to 98.8% for mumps." Merck knew from its Protocol 007 testing that this falsely represented the efficacy of its mumps vaccine. Now that it is licensed, Merck's package insert continues to misrepresent the efficacy of its mumps vaccine, stating: "Clinical studies with a single dose of ProQuad have shown that vaccination elicted rates of antibody responses against measles, mumps, and rubella that were similar to those observed after vaccination with a single dose of M-M-R II" and "[a]ntibody was detected in 96.7% for mumps."

76. In 2006, Merck obtained a license from the EMA to sell the MMRII analogue (called MMRVaxpro) through the joint venture Sanofi Pasteur MSD. Merck used the falsified results of the "enhanced" PRN test to obtain this approval. The EMA actually cited Protocol 007 as a "pivotal clinical study" in support of its decision to grant the approval. Since then, Merck has been manufacturing MMR Vaxpro at its West Point facility for Sanofi Pasteur MSD to sell in Europe.

77. Around the same time, Merck also obtained a license from the EMA for Sanofi Pasteur MSD to sell Merck's ProQuad in Europe. As with MMRVaxpro, Merck's joint venture submitted the falsified results of Protocol 007 to the EMA as supportive clinical information in its vaccine application. Relying on this information, the EMA found "no major concern" about the efficacy of the mumps component of the vaccine.

78. Thus, by 2006, Merck had the exclusive licenses to sell MMRII and ProQuad in the U.S., as well as licenses to sell MMRVaxpro and ProQuad in Europe. Throughout this time, Merck falsely represented an efficacy rate of 95 percent or higher and engaged in scientifically deficient testing and outright fraud to assure this was the efficacy rate consistently associated with its mumps vaccine.

C. Merck's False Representations Through Its Application for a Labeling Change on Potency of MMRII

79. In 2007, Merck changed its MMRII labeling to reflect a decrease in the potency of the mumps component of the vaccine. Potency measures how much of the attenuated virus is included in each dose of the vaccine. The labeling change -- approved by the FDA -- allowed Merck to represent a lower minimum potency, from 20,000 to 12,500 TCID50 (or tissue culture infective dose, which is the scientific measure of vaccine potency). This represented a 37.5 percent reduction in how much of the attenuated virus could go into each dose of the vaccine.

80. At no time during Merck's efforts to secure approval to change its MMRII labeling did Merck disclose to the FDA what Merck knew about the diminished efficacy of the vaccine. Nor did Merck take any steps to address the efficacy information that was falsely represented in the labeling. That portion of the labeling remained unchanged.

81. Merck was thus representing throughout the approval process that it could actually reduce how much attenuated virus Merck put into each vaccine shot and still maintain its represented 95 percent efficacy even though Merck knew that at the higher potency the vaccine was nowhere near this efficacy. Clearly, if the FDA had known the truth about the vaccine's efficacy it would not have approved the labeling change to reduce the minimum potency.

D. Merck's False Reprsentations Through Recent Mumps Outbreaks

82. With Merck's significantly degraded vaccine as the only protection against the mumps in this country, there has remained a significant risk of a resurgence of mumps outbreaks. That is exactly what Krah -- who was well aware of the mumps vaccine's failings -- predicted would occur. In a conversation he had with Relator Krahling in the midst of the "enhanced" PRN testing, Krah acknowledged that the efficacy of Merck's vaccine had declined over time, explaining that the constant passaging of virus to make more vaccine for distribution had degraded the product. Krah predicted that because of this, mumps outbreaks would continue. And that is exactly what has happened.

1. The 2006 Mumps Outbreak

83. In 2006, more than 6,500 cases of mumps were reported in the Mid-West in a highly vaccinated population. This was the largest outbreak in almost twenty years and a significant spike from the annual average of 265 cases that had been reported for the years leading up to the 2006 outbreak.

84. The CDC, FDA and Merck publicly worked together to determine the cause of this 2006 outbreak. Of course, only Merck knew that outbreaks would occur because its vaccine had degraded over time and was weaker than what Merck represented. Nonetheless, Merck continued to represent its inflated efficacy rate and the government continued to believe that there was no problem with the vaccine. During the investigation of the outbreak, the CDC's then Director, Julie Gerberding, reaffirmed the CDC's view that nothing was wrong with the mumps vaccine, a belief fed by Merck's continued misrepresentations: "We have absolutely no information to suggest that there is any problem with the vaccine." Director Gerberding and the CDC emphasized that "[t]he best protection against the mumps is the vaccine."

85. Even though Krah, the Merck investigator who ran Protocol 007, expected outbreaks to increase because of the degraded product, scientists at the CDC and elsewhere continued researching to understand the origins of such a large outbreak within a highly vaccinated population. One of the leading studies was led by Dr. Gustavo Dayan, then a doctor at the CDC, and published in 2008 in the New England Journal of Medicine. After considering possible causes for the outbreak, Dr. Dayan recommended that "[f]uture studies will help evaluate national vaccine policy, including whether the administration of a second dose of MMR vaccine at a later age or the administration of a third dose would provide a higher or a more durable immunity." Gustavo H. Dayan, "Recent Resurgence of the Mumps in the United States," New England Journal of Medicine, 358;15 (Apr. 10, 2008) 1580.

86. Dr. Dayan's study ultimately concluded that "[a] more effective mumps vaccine or changes in vaccine policy may be needed to avert outbreaks and achieve elimination of mumps." Id. (emphasis added). Of course, if Dr. Dayan had the benefit of what Merck knew but willfully withheld from the government and the public, his findings would have been significantly less equivocal on what needed to be done to stop the reemergence of mumps outbreaks.

87. At the same time Dr. Dayan published his study questioning whether it may be time for a new vaccine, Merck publicly proclaimed that its mumps vaccine had not been changed since its introduction in 1967 and that Merck had no plans to change it. So, while Dr. Dayan questioned whether it "may" be time for a new vaccine, Merck attempted to reassure the public that there was no need for any such change. The vaccine worked just fine.

88. In another study on the 2006 outbreak, several scientists questioned Merck's use of the Jeryl Lynn strain, instead of the wild-type virus, in Merck's PRN testing. They noted that with this kind of testing, vaccine efficacy can be significantly overstated because "good results can be obtained that do not reflect the actual ability of the vaccine to provide protection from disease. A vaccine failure is investigated properly only if, in addition to avidity testing, the ability of antibodies to neutralize wild mumps virus has been checked." Heikki Peltola, et al., "Mumps Outbreaks in Canada and the United States: Time for New Thinking on Mumps Vaccine," Clinical Infectious Diseases, 2007:45 (15 Aug. 2007) 459, 463.

89. What is perhaps most notable about this study is that it scientifically questioned Merck's stated efficacy based solely on Merck's use of the vaccine strain instead of the wild type virus to test efficacy. The critique did not (and could not) even account for Merck's concealed efforts to further inflate its efficacy results with the improper use of animal antibodies and the falsification of test data.

90. Currently, Emory University is conducting a clinical trial of its university students in yet another attempt to explain the cause for the 2006 mumps outbreak among college-age students who had received both doses of the vaccine. However, Merck is listed as a collaborator on that study, thus continuing to position itself to perpetuate its fraudulent efficacy findings.

91. Merck's ongoing misrepresentations and omissions with respect to the effectiveness of its vaccine continue to conceal the role its degraded product playoed in the 2006 outbreak.

2. The 2009 Mumps Outbreak

92. In his 2008 study, Dr. Dayan also predicted another mumps outbreak would follow three years after the 2006 outbreak. This followed from the three-year cycles in which outbreaks occurred before children were widely vaccinated for mumps. "[I]n the pre-vaccine era, mumps activity followed 3 year cycles, so the current low activity rate [at the time of his 2008 study] may be transient while another critical mass of susceptible persons accrues." Dayan, New England Journal of Medicine, 358;15 at 1587-88.

93. In August 2009, another mumps outbreak began just as Dr. Dayan predicted. As with the 2006 outbreak, the 2009 outbreak occurred despite high vaccination coverage among the U.S. children's population. In total, roughly 5,000 cases were confirmed by the CDC during the 2009 outbreak. This outbreak reaffirmed Krah's prediction that mumps outbreaks would reemerge and increase over time.

94. Faced with a mumps outbreak in 2006, and without complete information as to what might have caused it, the CDC acknowledged that it would consider the possibility of recommending a third dose of mumps vaccine. According to the Deputy Director of the CDC's Viral Diseases division in 2008, "If there's another outbreak, we would evaluate the potential benefit of a third dose to control the outbreak."

95. Because of the 2006 and 2009 outbreaks, the CDC has also pushed back its target date for eradicating mumps from its original 2010 goal to no earlier than 2020. But no amount of extra time or dosages will be enough to eliminate the disease when the vaccine does not work as represented in the labeling. It will merely allow Merck to continue to misrepresent the vaccine's efficacy and thereby maintain its exclusive hold on the mumps market with an inadequate vaccine.

96. To date, the government has not acted on Dr. Dayan's conclusion that it "may" be time for a new mumps vaccine. Instead, it continues to build its strategy around the existing vaccine. Nor is Dr. Dayan likely to pursue his own conclusion. He left the CDC to take a position in the Clinical Department of Sanofi Pasteur, the vaccine division of the Sanofi Aventis Group, Merck's partner in manufacturing and selling MMRVaxpro and ProQuad in Europe. Dr. Gerberding has also left the CDC. In January 2010, she became the president of Merck's Vaccine Division, a position she holds currently.

E. Merck's False Representations Through the Immunization Action Coalition

97. The Immunization Action Coalition (IAC) is a non-profit organization which describes itself as the "nation's premier source of child, teen, and adult immunization information for health professionals and their patients." It provides educational materials and "facilitates communication about the safety, efficacy, and use of vaccines within the broad immunization community of patients, parents, health care organizations, and government health agencies."

98. The CDC works closely with the IAC. Indeed, "[a]lmost all of IAC's educational materials are reviewed for technical accuracy by immunization experts at the CDC." The CDC also provides the IAC with financial support for the purpose of educating health care professionals about U.S. vaccine recommendations. Several CDC physicians currently serve on IAC's Advisory Board. So does the current Director of the National Vaccine Program Office at the Department of Health and Human Services.

99. Merck also provides funding to the IAC.

100. The IAC asserts that Merck's mumps vaccine has an efficacy rate of 97 percent. This comes from the following mumps vaccine "Question and Answer" information sheet posted on the IAC's website: "How effective is this vaccine? The first dose of MMR vaccine produces good immunity to ... mumps (97%)."

101. Merck has done nothing to correct this widely disseminated misinformation, sanctioned and supported by the CDC, about the efficacy of Merck's mumps vaccine. If anything, through its funding and support of the IAC, Merck has once again positioned itself to facilitate the spread of this false efficacy information. Clearly, if the CDC were aware of the true efficacy of Merck's mumps vaccine and the effort Merck has undertaken to conceal it, the CDC would take steps to correct the IAC's information on the vaccine.
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