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03/19/04 07:47:56

dadelp

http://bmj.bmjjournals.com/cgi/eletters/328/7440/602-c#53591

 

http://bmj.bmjjournals.com/cgi/eletters/328/7440/602-c#53591

 

The Tragic Second Hit.

 

As quoted by Mr. Clifford G. Miller, my statement was ‘Some parents have

also reported that their children, after improving on special diets,

supplements and behavioral therapy, regressed a second time around the age

of 5 years shortly after receiving their MMR booster. Such double-hit

situation (challenge-rechallenge) has been accepted in courts and by a

committee of the Institute of Medicine (IOM) as proof of causation’. (1) Mr.

Miller has interpreted the above as implying that the IOM and US Courts

accept evidence showing a double reaction, first to the initial MMR

inoculation and again to the MMR booster, as proof of causation. When Mr.

Miller contacted me, I informed him that my reference to the IOM was about

another vaccine and that the Court litigations involved certain medications

and not the MMR vaccine. His legal interpretation of the situation is

nevertheless still valid, and on target, when he states “… it seems a

logical and possible premise for a court to follow

on a balance of probability in the absence of any other cogent and

persuasive proof of causation. If that is the case, then this debate was

over long ago and that also means it may have been prolonged unnecessarily

by whatever interests there are that have been using science in a manner in

which it is not intended. This may well have again have caused damage to the

reputation of science in the public mind, when it can be such a powerful

tool for good.”

 

My reference to the IOM is based on two documents. The first is a 1991 IOM

report entitled “Adverse Effects of Pertussis and Rubella Vaccines” and

edited by Howson, Howe and Fineberg. On page 48 the editors stated: " In the

case of hemolytic anemia, a single striking case was sufficient to suggest

biologic relevance” and under Summary on page 159: “… the case described by

Coulter and Fisher (1985) is suggestive of a causal relation because

hemolytic anemia was detected 6 days after DPT immunization on two separate

occasions”. The second IOM report “Adverse Events Associated with Childhood

Vaccines: Evidence Bearing on Causality”: was published in 1994 and was

edited by Stratton, Howe and Johnston. On page 24, the editors listed

several criteria including …6. Dechallenge: Did the adverse event diminish

as would be expected if the vaccine caused the event ... 7. Rechallenge: Was

the vaccine redministered? If so, did the adverse event recur? On page 26

they added " Rechallenge is

unusual, because physicians are unlikely to readminister a vaccine

previously associated with an adverse event. When rechallenge does occur,

however, the recurrence or non recurrence of the adverse event will often

have a major impact on the causality assessment”. The above references

should be available from the IOM. (2)

 

As mentioned, the principle of Challenge and Re-Challenge has also been

cited, in several Court proceedings involving Selective Serotonin Reuptake

Inhibitor (SSRI) litigation. Interested attorneys can obtain those

transcripts by simple Lexus-Nexus and Google searches. As for physicians,

the following three documents may be more informative. The first is a

comprehensive Power Point presentation on “Clinical Analysis of Adverse Drug

Reactions” by K. A. Calis, Pharm.D., MPH, of the National Institutes of

Health. (3) Under “Causality Assessment” on slide 38, Dr. Calis lists

De-Challenge and Re-Challenge after temporal relationship and before

dose-response relationship. On slide 45, under “Component of an ADR (Adverse

Drug Reaction) Report”, Dr. Calis once more lists “De-Challenge and

Re-Challenge information”.

 

The second article is by Ms. Vera Hassner Sharav, President of The Alliance

for Human Research Protection (AHRP) in New York. It is entitled “Where is

the Scientific Evidence to Justify Exposing Children to the Risks of

Antidepressant Drugs?” (4) and was submitted to the FDA

Psychopharmacological Drugs Advisory Committee. The author states:“The case

is particularly significant in demonstrating a causal effect of the drug

because: It occurred within the context of a controlled clinical trial;

Violent symptoms developed with start of “Drug” (challenge); The symptoms

ceased when the drug was stopped (dechalllenge); Suicidal symptoms returned

when the drug was restarted (rechallenge); Suicidal symptoms cleared a

second time when the drug was again stopped”.

 

The last reference, “Suicide and Neuropsychiatric Adverse Effects of SSRI

Medications: Methodological Issues” by Ronald Wm. Maris, PH.D, Professor

Emeritus, University of South Carolina, was read at a symposium in

Philadelphia on October 4, 2002. (5) Dr. Maris stated:

“Challenge/Dechallenge/Rechallenge studies are a useful and reliable

methodology in suggesting drug or SSRI drug causation. In a

challenge/dechallenge/rechallenge study patients or subjects are given

specific ADs /SSRIs (See Rothchild & Locke, 1991; King, Riddle, Chappell et

al., 1991; Beasley rechallenge protocol for Lilly, 1991). If an adverse

reaction occurs, the drug may then be discontinued. The adverse side-effect

may also stop. Finally, the AD drug may then be readministered and the

adverse side-effect may reoccur. Other things being equal, it is

scientifically sound to posit in such circumstances that this drug was a

proximate cause of the adverse side-effect (See Grounds et al., 1995;

Teicher et al., 19

90; Mann, 2000: 100).”

 

Many families, including our own, have seen and documented regressions after

the first MMR vaccination and then again after the booster. Even if the

parents were lured into believing that the initial regression was “just a

coincidence”, no one can convince them or for that matter convince a Judge

or Jury, that a profound second regression, after a period of improvement,

is still yet another coincidence. The tragedy of this situation is that 92

to 95% of children develop immunity to all three diseases after receiving

their initial MMR.

 

References

 

1. Regressive Autism and MMR Vaccination F. Edward Yazbak, MD, FAAP, TL

Autism Research. http://www.redflagsweekly.com/yazbak/2003_nov01_1.html

 

2. The Institute of Medicine of The National Academies 500 Fifth Street NW,

Washington DC 20001 E-Mail: iomwww. Website: www.iom.edu Tel: 202

334.2352 .Fax: 202.334.1412

 

3. http://www.cc.nih.gov/ccc/principles/CALIS%20SLIDES%202002- 2003.ppt

 

4. http://www.researchprotection.org/risks/SSRI0204/AHRP.html

 

5. http://www.oism.info/teoria_prassi/2002_03_gb.htm

 

Competing interests: Grandfather of a boy with two documented regressions,

autistic enterocolitis and evidence of Measles Genomic RNA.

 

 

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