(This was posted by Patrick Sullivan Jr.)
I recently wrote a blog post called Autism/Mercury - How Much Evidence is Enough?. My summary of the article -- On Evidence, Medical and Legal -- co-authored by Dr. Donald Miller and Clifford Miller, Esq. was basically, the anecdotal evidence of one case (like Kevin Champagne's or Scott Shoemaker's) is more reliable as proof when building a "factual matrix" than epidemiological studies and randomized controlled studies because these have been demonstrably corruptible. (Please note that I am NOT saying all epidemiological studies and RCTs are corrupt! Only that by their very nature, they can easily fall prey to corruption, bias, etc. and the Millers' article demonstrated that.)
Pat and I received an email from Clifford Miller earlier this week. Mr. Miller is the "Legal" side of the "Miller equation" and he hails from the UK. The following was posted with his permission. (My emphasis throughout.)
Just to clarify a few important aspects with you:
Our medical friends have a problem with eye-witness evidence because they have not yet come to terms with the fact that it can be corroborated and tested and is part of the factual matrix which is essential to compile in any investigation, medical, legal or other. It is not appropriate for them to refer to any eye-witness testimony, parental or otherwise as 'anecdotal'. Anecdotes are sometimes the sorts of stories heard over dinner and sometimes embellished beyond belief in the interests of humour.
Eye-witness testimony is not anecdote and it is worth noting the distinction and dropping the use of the term. Each parental story can be documented and tested against medical records, photographs, video, other contemporary records, the evidence of others who also witnessed the same events. When I used the term 'anecdotal' with respect to the recollection of events over 40 years ago by a well-known US medical professor, others took umbrage that I described it as such - and the reactions indicated they considered the term to be tantamount to abuse. So if they do not like it when used to describe what they say, then they should not use it to describe what a parent eye-witness says. This is especially when that is in the form of formally documented testimony, corroborated and substantiated by cross-correlations to other forms of evidence.
Mr. Miller makes an EXCELLENT point here. Eye-witness testimony, corroborated by medical records, video-tapes, etc. should NOT be given the label "anecdotal" because that label is technically incorrect. Turns out, the dictionary agrees with him...
anecdotal: Based on casual observations or indications rather than rigorous or scientific analysis
I stand corrected. Thank you Mr. Miller.
He then goes on to say:
Also, well documented positive dechallenges and rechallenges are stand-alone proof. They are not a mechanism to corroborate parental eye-witness testimony, but naturally, they can have that effect. Further, the parental eye-witness testimony can be one part of the factual matrix documenting whether a positive rechallenge has taken place, so the two are not necessarily unrelated in that sense.
Dechallenge and rechallenge are also part of the furniture of pharmacology. They are nothing new and are in use daily. They are written into drug company and governmental regulatory procedures the world over.
The main problem for the public is that the average treating physician and clinician is not aware of this kind of evidence nor of its power. The other issue for the public is that bodies like the IOM seem to choose to ignore it when it comes to whether MMR or other vaccines are a cause autism. Now that is a strange state of affairs [which] seriously and adversely affects the IOM's credibility - and I know some would take me to task on that and say 'What credibility?'. [ed note. <grin>]
For example, the IOM publicly have accepted positive rechallenge as proof of causation: From a 1991 IOM report (Adverse Effects of Pertussis and Rubella Vaccines)
Page 48: "In the case of hemolytic anemia, a single striking case was sufficient to suggest biologic relevance "
Also from page 48: "Individual cases of adverse event could be examined to determine whether the event occurred in a clear sequence following each pertussis immunization in the series. An increasing severity of the event with increasing dose number would tend to support a causal interpretation. If the event tended to diminish in severity or was absent for later doses in the series, the evidence would tend to detract from a causal interpretation."
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 "
Yet the committee concluded: "There is insufficient evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and hemolytic anemia."
In another IOM special report (1994) titled "Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality" page 24:
6. Dechallenge: Did the adverse event diminish as would be expected if the vaccine caused the event ...
7. Rechallenge: Was the vaccine readministered? If so, did the adverse event recur?On page 26: "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 nonrecurrence of the adverse event will often have a major impact on the causality assessment"
It is disturbing to note that Dr. Andrew Wakefield presented his dechallenge and rechallenge case series in 2001 to the IOM Immunisation Safety Review Committee. In an interview with small Canadian autism charity he says: '... they became anxious and agitated. They then asked for the data to be provided to their closed session the following day. ... Yet they didn't mention the relevant parts of any of my testimony or data in the final report.'
Wakefield says what happened next: "I raised this issue at the second congressional hearing on autism and vaccines in front of Marie McCormack, Chair of the Institute of Medicine's Immunization Safety Review Committee. Representative Dan Burton told Dr. McCormack that they needed the transcript from that closed session. She explained that it was not their policy to release transcripts. He said in his own idiosyncratic style that they would then be subpoenaed, though he put it more forcefully than that. So, they were subpoenaed and the tapes were sent. They just happened to be blank. These were copies of the original tapes, so Representative Burton said, 'Okay, then in that case we will have the original tapes.' So they requested the original tapes—and they were blank as well."
Regards, Clifford Miller
To close, I'll pull out a very relevant comment that John Johnson, PhD statistician who works in the pharmaceutical industry, posted in response to the first On Evidence post:
Once, after my daughter ate a popsicle, she developed a rash around her lips. The only ingredient present that could not be ruled out (because she had all the other ingredients before) was FD&C Yellow #5. A few hours later, the rash went away. The next time she had a food with that ingredient, the rash returned. Symptoms disappeared on de-challenge, re-appeared on re-challenge, which is the accepted criteria for adverse event with definite causality.
Which am I to believe more? The "anecdotal evidence" or studies that suggest FD&C Yellow #5 is a safe ingredient?
Everybody's body is different. Studies did not very well predict 40 deaths attributed to Baycol or 11 cases of suicidal thinking due to Strattera. Maybe most of the others received some benefit (maybe other methods could have had more benefit, with fewer side effects, but that's another discussion), but that's immaterial to those affected families.
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