|Clifford G. Miller,
Lawyer & graduate physicist
Beckenham Kent BR3 6QX
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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 chairmanship 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 purported 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 report 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 supported 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 purported 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 relationship between adverse reactions and drug. These are adapted from Karch and Lasagna (1975). 1. Definite. A reaction that follows a reasonable temporal 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 relationship 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 importance 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 relationship," 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 relationships 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 report 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 Report 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.