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False Testimony Denies Lancet Doctors a Fair Hearing



 
 
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  #1  
Old January 29th 10, 03:48 PM posted to misc.health.alternative,misc.kids.health,sci.med
john[_5_]
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Default False Testimony Denies Lancet Doctors a Fair Hearing

False Testimony Denies Lancet Doctors a Fair Hearing
http://www.ageofautism.com/201

(27 January, London) A First Amended Complaint on behalf of 21 US and UK
autism and vaccine safety advocacy organizations against Drs. Horton,
Salisbury, Zuckerman, Pegg, and Rutter alleging, inter alia, that they gave
false statements and testimony as prosecution witnesses in the proceeding
brought by the General Medical Council (GMC) has been filed today. The
false testimony on the two core issues (alleged conflicts of interest and
unethical research) has irrevocably corrupted the proceeding against Drs.
Wakefield, Walker-Smith, and Murch, and deprived them of a fair hearing.
The objective documentary evidence demonstrates that Dr. Wakefield did not
have a disclosable financial conflict; that Dr. Horton (Lancet Editor) was
well aware of Dr. Wakefield's participation in MMR litigation, suppressed
that knowledge from the public, and then feigned surprise six years later in
order to shift "blame' for publication of the controversial article to Dr.
Wakefield; and that the Ethics Committee had approved the taking of
additional biopsies by colonoscopy well before any of the 12 Lancet children
were examined. We call upon the GMC to immediately dismiss the complaints
against Dr. Wakefield, Walker-Smith, and Murch and begin an appropriate
investigation against Drs. Horton, Zuckerman, Salisbury, Pegg, and Rutter.


Summary of the Allegations in the First Amended Complaint

This First Amended Complaint includes two new Counts against Professor Sir
Michael L. Rutter. Count VII alleges that he failed to disclose in at least
four papers published between 2005 and 2009 that he had a crucial
conflicting financial interest as a highly paid expert witness for the
vaccine industry (and for the U.S. Government that defends industry in
Vaccine Court) in at least three major litigation projects, U.S. litigation
concerning mercury (thimerosal) as a cause of autism, the U.K. MMR
litigation, and the U.S. Omnibus Autism Proceeding (concerning both MMR and
thimerosal as causes of autism). Although Professor. Rutter's
non-disclosure of a conflicting financial interest is precisely the same as
that alleged against Dr. Wakefield (involvement in MMR litigation), the
scope of Professor. Rutter's wrongful conduct is far worse, involving
multiple litigation projects, at least four papers, and the more stringent
modern disclosure obligation.
Count VIII alleges that Professor. Rutter gave false expert testimony in
this FTP hearing by stating his opinion that Dr. Wakefield had a duty to
disclose his participation in MMR litigation in the Lancet Case Series. In
the alternative, Professor. Rutter misled the Panel by hiding his own
non-disclosure of the same type of conflicting interest for which he
condemns Dr. Wakefield. If Professor. Rutter doesn't honestly believe
(although this would contravene the express language in the modern
disclosure guidelines) that acting as a litigation expert on precisely the
same subject discussed in his published papers (and on which he relies for
his opinion in litigation) is a disclosable conflict, then he is falsely
accusing Dr. Wakefield of breaching a non existent duty. Or, if he honestly
believes this is a disclosable interest, then his testimony is false and
misleading because he has concealed the fact of his own pattern of non
disclosure.

Allegations in the Original Complaint

Count I alleges that Dr. Horton knew of Dr. Wakefield's participation the UK
MMR litigation, did not consider it a disclosable interest, and hid this
knowledge from Lancet readers in 1998. Dr. Horton's claim six years after
publication of the Lancet Case Series that it would never have been
published had he known of Wakefield's participation in MMR litigation was
false because he was twice informed of Dr. Wakefield's relationship with MMR
litigation a year before and five days after publication. Horton, not Dr.
Wakefield, decided that the disclosure of a "perceived" conflict (where no
actual conflict existed) was simply not necessary as part of the published
Case Series. He concealed the Lancet's knowledge of Dr. Wakefield's
participation in MMR litigation when the possibility of "litigation bias"
was raised by a reader immediately after publication. Attachment 1 is a
side-by-side comparison of the letters received by Horton four days after
publication, and the redacted version published in May, 2008. By feigning
ignorance of the Wakefield litigation relationship, and outrage at somehow
being misled, six years later when the allegations were raised by Deer,
Horton was able to shift "blame" for decisions he had made and information
he had concealed to a scapegoat (i.e. Drs. Wakefield, .Murch, and Walker
Smith) once it had become evident that someone had to pay a price for the
"unpleasantness" surrounding vaccine safety concerns. Moreover, Horton
conspired with a "medical regulator" to motivate a GMC investigation while
boasting that the GMC "had not a clue where to begin."

Count II alleges that Dr. Horton's informal "gag" rule barring publication
of material critical of vaccine safety breaches his professional duty as
Editor of the Lancet to support scientific freedom and freedom of inquiry
and avoid censoring material that might be "politically" unpopular or
critical of industry. Dr. Horton's de facto "gag" rule censoring
publication of science that calls vaccine safety into question obstructs
justice by depriving the courts of the evidence they would need to find a
vaccine caused injury and is an unprofessional and misguided attack on the
ethics of scientists and lawyers who would work together to seek justice for
injured children.

Count III alleges that then Dean Zuckerman falsely denied his knowledge that
Dr. Wakefield would, if asked at the press conference accompanying
publication, recommend the single (monovalent) measles, mumps, and rubella
vaccines as a precautionary measure until the safety of MMR could be further
examined. Dr. Zuckerman's claim that he was unaware that vaccines would be
discussed at a press conference accompanying publication was false because
he had specifically instructed Dr. Wakefield to urge continued use of the
monovalent measles vaccine as a safer alternative to MMR. Attachment 2 is
Dr. Zuckerman's Jan. 22, 1998 letter instructing Dr. Wakefield to recommend
the monovalent vaccines at the post-publication press conference ("It is
vital, in your own interest and that of children, that you state clearly
your support for monovalent vaccination.").

Count IV alleges that Dr. Pegg falsely claimed that the research biopsies
for the Lancet children had not been approved by the Ethics Committee. Dr.
Pegg's claim that the research aspects of Lancet Case Series were unethical
was false because his own Ethics Committee had approved the collection of
tissue samples (as project 162-95) well before the first child was ever
examined. Attachment 3 is the Ethics Committee Sept. 5, 1995 approval
letter for research biopsies.

Count V alleges that Dr. Salisbury has seriously misled the public by making
unsupported claims regarding MMR safety. Dr. Salisbury's claim that MMR has
an "exemplary" record of safety is unfounded and misleading. Two of the
three brands of MMR have been withdrawn for safety reasons He has misused
his official position by attempting to discredit and silence Dr. Wakefield
and others who have a moral and ethical duty, and a right of free speech, to
criticize the safety of MMR. Count VI alleges that he has also concealed
material information relating to the safety of MMR from the public.

The False Testimony Has Fatally Inflused this FTP Hearing

The allegations of false and misleading testimony are directly relevant to
the core charges before the Panel. Not only did Dr. Wakefield have no duty
under the then-applicable disclosure standard, it was actually Dr. Horton
that concealed Dr. Wakefield's participation in the MMR litigation, only to
later feign ignorance to shift blame to a scapegoat for all the
"unpleasantness" surrounding the debate over MMR safety. The research
aspects of the biopsies on the Lancet children had in fact been approved by
the Ethics Committee as Project 162-95. Professor. Rutter could not have
honestly believed that Dr. Wakefield violated a disclosure obligation
because he did not disclose his own much more extensive participation as an
expert in defense of the vaccine industry in several papers. More
generally, it will be impossible for the Panel to distill any remaining bits
of honest testimony because the false testimony has been so pervasive and
has infected the core subjects of this inquiry.

The Interest of the Complaining Organizations

The false testimony alleged in the First Amended Complaint has harmed, and
will continue to harm, children by chilling and reducing funding for
research into causes of and treatments for autism, and clinical care. The
documentary evidence now reveals that there was no merit to the core
allegations brought in 2004 by Complainant Brian Deer. Furthermore, the FTP
proceeding has been irreparably tainted by false testimony. Accordingly,
the Organizations in the First Amended Complaint ask that the FTP hearing
against Drs. Wakefield, Murch, and Walker Smith be terminated immediately.
Declaring this diversion at an end will facilitate a return to the urgent
scientific and public health challenge at hand, finding the cause of and
treatments for autism, and restoring public confidence in the vaccination
program with an aggressive 'safety first" research agenda. The false
testimony and the ensuing GMC FTP hearing have had the effect of delaying
necessary research into cause and treatment for autism, and dissuading
scientists from pursuing research relating to vaccines as a cause of chronic
disease. The ultimate victims of this false testimony are children whose
autism could have been prevented or more effectively treated.

The MMR Controversy

This inquiry does not address and will not resolve the growing controversy
over MMR safety, and the safety of the vaccine schedule in general. In
2005, the prestigious Cochrane Collaboration concluded, "The design and
reporting of safety outcomes in MMR vaccine studies, both pre- and
post-marketing is largely inadequate. The evidence of adverse events
following immunisation with MMR cannot be separated from its role in
preventing the target diseases." Demicheli V, Jefferson T, Rivetti A, et al.
Vaccines for measles, mumps and rubella in children. Cochrane Database Syst
Rev, 2005(4):CD004407. To date, the US Vaccine Court has paid 295 damage
awards, and in vaccine injury cases decided since 1988 has paid $1.8 billion
(an under-estimate of actual injury because of a very short statute of
limitations).

The Vaccine-Autism Controversy

The US Vaccine Court (by decision) and the US Government (by concession)
have concluded that vaccines, specifically MMR, can cause autism. The
debate, and the need for reallocating research support, now shifts to how
many children have been affected (for purposes of compensation) and how to
prevent new cases and treat those already vaccine-damaged.

Vaccine-caused autism was first described in the medical literature by Sir
Michael Rutter. In a lengthy review article on the biological basis of
autism, Sir Michael described a genetic study of families affected by
autism, from which some children were excluded on the basis that their
autism could be explained by some known "medical condition of probable
aetiological [causal] importance." Sir Michael explained one of the
exclusions: "Only eight of the cases can be regarded as having a probably
causal medical condition, a child with epilepsy and a temporal lobe focus on
the EEG [Electroencephalogram] who had an onset following immunization."
Rutter M et al., "Autism and known medical conditions: myth and substance,"
J Child Psychol and Psychiat. 1994;35:311-322.

The "vaccine court" in the United States began compensating vaccine autism
claims in 1991. See Kleinert v. Dept. of Health and Human Services ("HHS"),
1991 WL 30664, (Cl.Ct., 1991 (No. 90-211V) (seizure disorder after DPT which
is under control and a condition known as over-focussing, similar in some
respects to autism). Since then, the court has published at least nine more
decisions awarding compensation for vaccine-caused autism. HHS has found the
evidence so persuasive that it has conceded liability before trial in an
unknown number of autism cases. In a 2001 concession, Hiatt v. HHS, a child
with MMR-caused autism was awarded $5.1 million dollars. In a case conceded
in 2007, Poling v. HHS, a child who received five vaccines (nine antigens)
in one day, one of which was MMR, developed autism. See Kirby, "The Vaccine
Court Document Every American Can Read," Huffington Post (Feb. 26, 2008) CBS
News: Court Links Hepatits B Vaccine to a Death.

In the most recent MMR case, the court found liability for MMR-caused ASD.
See Banks v. HHS, 2007 WL 2296047 (Ct. Cl. 2007) (No. 02-0738V). The Court
found that Bailey would not have suffered this delay but for the
administration of the MMR vaccine...a proximate sequence of cause and effect
leading inexorably from vaccination to PDD (autism). The Court ruled in a
subsequent MMR case, Zeller v. HHS, 2008 WL 3845155, that the vaccine caused
brain injury and developmental delay.

The Threat to Clinical Medicine

Much of this case surrounds the boundary between clinical care and research
on human subjects (requiring ethics approval). GMC guidance specifically
excludes "innovative therapeutic interventions" from the definition of
"research." But this is precisely what the Royal Free was providing to
desperately ill children. For a disciplinary body ten years later to
reclassify clinical care as "research" (putting the licenses of some of the
most prestigious doctors in the world) strikes at the heart of the
profession of medicine, and will forever "chill" quality care.

Growing Concerns Over Prosecution Misconduct

In addition to issues of credibility, there is increasing concern of
prosecutorial misconduct that the panel may wish to consider, including the
intentional or negligent use of false testimony, withholding crucial
evidence, and the mis-wording of a key charge.

Charge 39 Alleges the Wrong Disclosure Standard:

Charge 39 defines a "disclosable interest" as including:

matters which could legitimately give rise to a perception of a conflict of
interest in relation to your role as a co author of the Lancet paper.

This was not the disclosure standard applicable to Dr. Wakefield in 1998,
which was:

The conflict of interest is a simple one. Is there anything e.g. a
shareholding in or receipt of a grant or consultancy fees from a
pharmaceutical company or a contract from a medical devices manufacturer
that would embarrass you if it were to emerge after publication and you had
not declared it.

The Lancet's rules in 1998 allowed authors to judge for themselves what they
considered to be a conflict and disclose as necessary. However, the
disclosure standard charged by the prosecution invites the Panel to judge a
disclosable interest by an objective "reasonable person" standard. This
reflects the current and much more strict standard, developed beginning in
2001. Dr. Horton and several journal editors explained the development of
this more objective approach to disclosable conflicts as "The potential for
conflict of interest can exist whether or not an individual believes that
the relationship affects his or her scientific judgment." Davidoff, M., et
al., "Sponsorship, Authorship, and Accountability," Lancet. 2001 Sep
15;358(9285):854 6. The prosecution charged the wrong standard because it
had no evidence of Dr. Wakefield's state of mind, and therefore could not
prove, a violation of the subject standard extant in 1998.

Prior Approval of Biopsies By Ethics Committee

Documents recently released under the Freedom of Information Act reveal that
Complainant Brian Deer was specifically aware the taking of biopsies on the
Lancet children for research purposes had the prior approval of the Ethics
Committee, and therefore that his 2004 allegation of unethical research was
false. Presumably he turned over this document to the GMC; otherwise he
would have risked exposure as a fraud for withholding key evidence following
any serious initial investigation by the GMC staff. Thus, the prosecution
may have known as early as Deer's Complaint that the biopsies Attachment 4,
had been approved by the Ethics Committee under project code 162-95. It is
entirely possible that Deer withheld this document (although that would call
into question his status as a bona fide investigative journalist), but a
competent investigation should have uncovered the 162-95 approval. As
alleged in the First Amended Complaint, Dr. Pegg (then Chairman of the
Ethics Committee) gave false evidence and testimony by failing to
acknowledge the 162-95 approval (perhaps because he failed to fulfill his
duty under GMP to adequately investigate and prepare his testimony).
Nevertheless, the actual approval letters for 162-95 were placed in evidence
by Dr. Walker-Smith. See Ex. 38 (Sept. 5, 1995 Ethics Committee letter
granting approval of project 162-95). Even if there had been no prior
knowledge of the ethics approval on the part of the prosecution, the charges
relating to the lack of ethics approval should have been summarily dismissed
at this point. The 93 pages of GMC charges contain 89 references to 172-96
and specifically state there was no other applicable ethical approval. The
pendency of allegations by an official body, GMC, of unethical research, now
shown objectively to be false, causes ongoing harm to the accused doctors.

False Evidence and Testimony

The false testimony by five key prosecution witnesses has irreparably
tainted this proceeding, undermining the guarantee of a fair decision. The
integrity of the GMC is at risk in this proceeding. GMC has a solemn and
vital responsibility to protect patients and public trust in the medical
profession. But it is now clear that this prosecution was not brought in
good faith, and should have been dismissed long ago. By re-labeling
"innovative therapeutic interventions" and appropriate clinical care as
"unethical research" and exposing the routine day-to-day decisions of a
dedicated team of the country's leading scientists to meticulous scrutiny at
risk of medical license, the practice of medicine will become increasingly
mediocre and a noble profession turned into unskilled labor. This case is
more a witch hunt or show trial, brought to settle old scores, "blame"
innocent scapegoats for actions and inactions taken by many of the
prosecution witnesses, conceal the poor quality of care given to desperately
ill autistic children, divert attention from the lack of adequate research
on vaccine safety, and generally to cover a host of backsides. The
"chilling" damage done to these hard-working and dedicated doctors and to
doctors and scientists generally - and thereby to the children they care
for - is incalculable.


Contact:
Jim Moody
1101 30th Street NW.
Suite 300
Washington, DC. 20007
2920298-4766
202-246-6639 [mobile]


Useful Websites:
www.ageofautism.com
www.nvic.org
http://thoughtfulhouse.org/supporting_research.php [science summary]
www.safeminds.org
http://safeminds.org/mercury/vaccines-and-autism.html [science summary]
www.fourteenstudies.com [critique of epidemiology studies]
http://fourteenstudies.com/ourstudies.html [science summary]
www.nationalautismassociation.org


  #2  
Old January 29th 10, 06:36 PM posted to misc.health.alternative,misc.kids.health,sci.med
john[_5_]
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Posts: 822
Default False Testimony Denies Lancet Doctors a Fair Hearing

There is a website where people can sign in support of or click a
link to send a message of support to Dr. Wakefield or have a letter
considered for posting: http://www.wesupportandywakefield.com/


  #3  
Old January 30th 10, 07:56 AM posted to misc.health.alternative,misc.kids.health,sci.med
Peter Bowditch
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Posts: 1,038
Default False Testimony Denies Lancet Doctors a Fair Hearing

"john" wrote:

There is a website where people can sign in support of or click a
link to send a message of support to Dr. Wakefield or have a letter
considered for posting: http://www.wesupportandywakefield.com/


I was going to sign as Joseph Mengele but someone beat me to it.

--
Peter Bowditch aa #2243
The Millenium Project http://www.ratbags.com/rsoles
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To email me use my first name only at ratbags.com

Sponsor me in the World's Greatest Shave
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  #4  
Old January 30th 10, 12:08 PM posted to misc.health.alternative,misc.kids.health,sci.med
john[_5_]
external usenet poster
 
Posts: 822
Default False Testimony Denies Lancet Doctors a Fair Hearing


"Peter Bowditch" wrote in message
...
"john" wrote:

There is a website where people can sign in support of or click a
link to send a message of support to Dr. Wakefield or have a letter
considered for posting: http://www.wesupportandywakefield.com/


I was going to sign as Joseph Mengele but someone beat me to it.


That's a good tag line for you.


 




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