MMR KIDS - LIVING SCIENTIFIC PROOF MMR CAUSES AUTISM23 July 2004
Clifford G. Miller,
Lawyer & graduate physicist
Beckenham Kent BR3 6QX
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Re: MMR KIDS - LIVING SCIENTIFIC PROOF MMR CAUSES AUTISM
Email Clifford G. Miller
Dear Sir,
MMR KIDS - LIVING SCIENTIFIC PROOF MMR CAUSES AUTISM
I challenge the Honourable Lord, Dick Taverne, to a scientific duel on his
view ('The legal aid folly that damages us all' BMJ 2004;329:239 (24
July),
doi:10.1136/bmj.329.7459.239).
For credibility he leans on chairman****p of a charity claiming to promote
an
'evidence based approach'.
Evidence? It is before him and the entire medical scientific community.
The
MMR children are living proof of challenge-dechallenge- rechallenge
reactions. Challenge-dechallenge-rechallenge is well established science
and
accepted as the strongest scientific proof existing of a causal connection
between a pharmaceutical preparation and an adverse drug reaction ('ADR')
(1).
A major omission from the published scientific papers which are cited as
pur****ted evidence of no link between MMR, autism and other ailments is
the
absence of any attention to test/re-test or
challenge/de-challenge/re -challenge tests as a drug research and
development tool. United States Congressman Dr Dave Weldon MD heavily
criticised the US Institute of Medicines' partisan 2004 re****t on
vaccination. Congressman Weldon specifically raised the issue (2) that
challenge-dechallenge-rechallenge studies have been ignored and studies in
that regard went unheeded:-
"In 2001 you found that cases of MMR "rechallenge" would provide evidence
in
favor of causality. It is my understanding that Dr. Wakefield has
developed
such a case series. The lack of an invitation is puzzling."
If challenge-dechallenge-rechallenge were to be applied to the two medical
case histories which the noble Lord can read in detail in Hansard (3) (4)
they should be recognised as living scientific proof of a causal
connection
between their ailments and the MMR vaccine. The pharmaceutical companies
have failed to apply this scientifically valid study of cause and effect
which is used particularly in the psychopharmacological world. Instead,
most
drug companies focus on the controlled clinical trial and epidemiological
studies. It is well known the latter, in particular, can be highly limited
and not necessarily strong or good evidence and the former have been shown
to be susceptible to manipulation, such that fraud is alleged by the US
New
York Attorney-General in a prosecution undertaken currently in the US.
The case histories of all the MMR children are repeatedly and wrongfully
dismissed by pro MMR science as valueless 'anecdotal' evidence whereas
direct oral parental evidence sup****ted and corroborated by documentary,
photographic and video evidence is the gold standard of our legal system
(5). Because of the high standard of proof science sets, viz,
irrefutability
and the failure of scientific method to have any mechanism to test this
kind
of evidence, it dismisses it as unverifiable. The consequences of this are
that science can only be relied on to prove a fact positively: the absence
of scientific evidence in science is not evidence of absence, especially
when there is other strong evidence available which should not be but is
ignored.
And the MMR childrens' real sin? Being such powerful living proof that
vaccination is dangerous and a deadly medical practice applied en masse to
the human population. These children threaten a pharmaceutical market
grown
over the past twenty years to be worth billions and a blindly followed
conventional wisdom that vaccination is generally something the evidence
shows it is not, a 'good thing' and safe. Is the entire medical community
intent on putting these children down and sweeping this shameful issue
under
the carpet, even to the extent of continually relying on scientific papers
based on very shaky 'evidence' (6)?
This does not happen just in relation to vaccines. It is a scandal across
the board, that even sweeping the Augean Stables of the MHRA would still
not
correct (although that is not an excuse for not getting the broom out).
It is troubling to see, as here, such a view expressed by a Peer of the
Realm, former barrister and Queen's Counsel. I entreat the noble Lord to
be
so kind as to consider heeding the admonition I set out on a previous
occasion (7).
The questions the noble Lord might consider asking himself and the
government are 'what kind of government poisons its own kids', why are
Liberal Democrats so involved, as MP Evan Harris also is, and exactly what
was going on between Whitehall and the LSC when legal aid was withdrawn?
___________________________________________________________________________
(1) Edited extracts from Professor David Healy''s evidence in the US
Forsyth
SSRI litigation in the US Courts - another of many other pharmaceutical
scandals:-
"Pharmaceutical companies focus on the controlled clinical trial and
epidemiological studies. This ignores a scientifically valid study of
cause
and effect used particularly in the psychopharmacological world, known as
test/re-test or a challenge/de-challenge/re-challenge test. This is well
established science and strong scientific proof of a causal connection
between a pharmaceutical preparation and an ''adverse event''. A major
omission in all of the papers published as pur****ted evidence of no link
between MMR, autism and other ailments is the absence of any attention at
all on rechallenges as a drug research and development tool. If this were
to
be applied to the MMR children, then each and every one of them could well
be recognised as the conclusive living scientific proof of a causal
connection between their ailments and the MMR vaccine.
The literature discussing the tools available for the development of drugs
refers to rechallenges as one of the most effective, most persuasive, most
cost-effective means for determining the side effects of drugs.
The Guide to Clinical Studies and Developing Protocols, published in 1984,
states on page 163:-
"In evaluating whether an adverse reaction is related to a specific test
drug, one should consider the following points: ... 6. Rechallenge, i.e.,
what happened if the drug was restarted after the adverse reaction had
disappeared? ... Definitions are given below for a five-category system
that
may be used to classify the relation****p between adverse reactions and
drug.
These are adapted from Karch and Lasagna (1975). 1. Definite. A reaction
that follows a reasonable tem****al sequence from administration of the
drug
or in which the drug level has been established in body fluids or tissues;
that follows a known or expected response pattern to the suspected drug,
and
that is confirmed by improvement on stopping or reducing the dosage of the
drug, and reappearance of the reaction on repeated exposure
(rechallenge)."
Drug Epidemiology and Post-Marketing Surveillance, contains several
references to the value of rechallenges in determining the relation****p
between drugs and their side effects. In Drug Development, Regulatory
Assessment, and Postmarketing Surveillance, the author also refers to the
value of rechallenges, citing a work by Irey and Karch and another by
Lasagna.
The Detection of New Adverse Drug Reactions has a full chapter describing
the im****tance and the use of rechallenges as a tool to investigate drug
reactions. On page 208, the text describes the positive rechallenge as
"probably the strongest proof of a causal relation****p," despite its
shortcomings.
A pharmaceutical company''s own research scientists have validated the use
of test-retest designs for the determination of cause and effect
relation****ps in regards to adverse effects. Dr. Charles Beasley, an Eli
Lilly senior scientist wrote in the British Medical Journal in a letter to
the editor on November 9, 1991, "Healy and Creaney's suggestion of using
rechallenge to determine causality of rare events is scientifically
appropriate." (Charles M. Beasley, Fluoxetine and Suicide, British Medical
Journal, Col. 304, November 9, 1991, p. 1200).
In December of 1991, Anthony J. Rothschild published a re****t of three
rechallenges which established a link between akathisia caused by Prozac
and
emergent suicidal tendencies (Anthony J.Rothschild, et al., Reexposure to
Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of
Akathisia, Journal of Clinical Psychiatry, Vol. 52, No. 12 (1991), pgs.
491-493.). The authors described a series of cases wherein Prozac caused
emergent suicidality associated with akathisia. In order to test whether
the
emergent suicidality was coincidental or was associated in a cause and
effect way with Prozac, the researchers first withdrew the Prozac, then
re-administered it (the re-challenge step). All three cases who were
re-exposed to Prozac after having made a previous serious suicide attempt
on
Prozac experienced the exact same effect on rechallenge. "All three
patients
developed severe akathisia during treatment with fluoxetine and stated
that
the development of the akathisia made them feel suicidal and that it had
precipitated their prior suicide attempts." The emergence of the same side
effect upon rechallenge is powerful evidence of cause and effect.
(2) Statement of Rep. Dave Weldon, M.D. Member of Congress Before the
Institute of Medicine February 9, 2004
(3) Health Select Committee Sixth Re****t 1998/99 - David Thrower's
Memorandum Appendix I - Degeneration of Oliver Thrower Into Autism - Case
History
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmhealth/549/99072718.htm
(4) Hansard 19th November 2003 - Norman Baker MP - debate regarding MMR
and
the effects on Michael and Terry Thomas, two of the four sons of Isabella
Thomas:-
http://www.publications.parliament.uk/pa/cm200203/cmhansrd/cm031119/debtext/31119
-
42.htm#31119-42_head0
(5) 'UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE'
http://bmj.bmjjournals.com/cgi/eletters/328/7440/602-c#52948
(6) see, eg http://bmj.bmjjournals.com/cgi/content/full/322/7284/460
'Mumps,
measles, and rubella vaccine and the incidence of autism recorded by
general
practitioners: a time trend analysis' BMJ 2001;322:460-463 ( 24 February )
and, 'CLARIFICATION SOUGHT FROM AUTHORS TO ESTABLISH EVIDENTIAL VALIDITY
OF
THIS PAPER' http://bmj.bmjjournals.com/cgi/eletters/322/7284/460#56882
(7) 'TIME FOR POLITICIANS TO ACT RESPONSIBLY AND ADDRESS THE ISSUES'
http://bmj.bmjjournals.com/cgi/eletters/328/7442/726-a#54697
Competing interests: Close relative with life threatening food allergy.
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