In response to Clifford Miller's opinions on medical science
I have noticed that no responder has challenged the opinions
expressed by this author, so I have decided to personally respond to his
incompletely informed opinions.
Clifford Miller is critical of medical science, but I think that he
does not really understand how medical science works, and he does not
seemingly understand the foundational basis of evidence-based medicine.
1) The author states -: “The main reason medical science is
potentially to be considered flawed, such as in the legal arena is
because, it intentionally, necessarily (for its own purposes) and
systemically fails to take account of evidence which is fundamental to the
deliberations of a court. Reliable evidence is that which is authentic,
accurate and complete. In short, scientific evidence is incomplete if used
for purposes outside the strict confines of science because it fails to
take account of evidence of lay witnesses of the facts and is hence only
applicable to the narrow and specific confines of scientific enquiry and
not the broader ones found in other fields of human endeavour.”
This series of sentences seems to be the central tenet of the
author’s critical attack on medical science. He seemingly believes that
evidence-based medicine (EBM) does not consider anecdotal evidence from
individual lay witnesses (or individual physicians). He is obviously in
error, because all textbooks on evidence-based medicine discuss the issue
of the apparent reliability of scientific evidence, and they all recommend
using a grading system (classification system) to assess the scientific
reliability of the EBM evidence. The highest level of evidence is evidence
from multiple randomised controlled trials that have consistently positive
results. The EBM evidence is deemed less reliable if there is
inconsistency in the results of multiple randomised clinical trials, or if
the trials have a low signal/noise ratio. Case control studies are
accorded a lower level of evidence, and the lowest level of evidence is
the evidence obtained from single case reports (anecdotal evidence).
Although single anecdotal case reports are regarded as a lower level of
evidence, it does not therefore imply that the field of EBM ignores
anecdotal reports. It simply means that EBM will not regard anecdotal
evidence as being totally reliable if it is not proven to be “authentic,
accurate and complete” (author’s words).
2) The author writes-: “Science treats evidence of lay witnesses of
fact as inadmissible (as ‘anecdotal’ only) for reasons which are
inapplicable in Court, but science does so for two main reasons. The
higher scientific standard of proof (in effect, irrefutability) only
admits evidence which can be tested scientifically for reliability. Oral
witness evidence is discounted by medical science because medical
scientific method does not currently have or recognise a mechanism for
testing oral evidence to the scientific standard and so, for the sake of
rigour, excludes it.
Neither of these propositions apply in Court. Evidence of the direct
witness of the fact, whether oral, or more frequently now, by way of
written statement, is always admissible and is, in fact, the keystone of
the trial system of evidence and the primary source of information a court
uses to make decisions of fact. The Court has and applies its own
mechanisms for testing witness evidence (eg. cross-examination). Further,
the Court applies a far lower standard of proof, namely a balance of
probability and not the unnecessarily high one of irrefutability applied
by science.”
The author seemingly suggests that the science of evidence-based
medicine is faulty because it does not utilise the same common sense
standards that are applicable to a courtroom — where all types of
anecdotal evidence are permissible and where the testing of the evidence
occurs through the process of cross-examination, and where the jury’s
final opinion is based on the balance of probability (preponderance of the
evidence). Again, I think that the author does not understand how unbiased
EBM practioners view the font of EBM evidence. I think that sensible
physicians view the EBM evidence (all levels of evidence) by utilising the
same simple common sense principles of probability. If the EBM evidence is
only based on a series of anecdotal reports, a sensible, but unbiased,
physician does not totally discount the evidence. He simply accords it a
lower level of evidence, which can run through the entire gamut from
possible-to-probable. If the EBM evidence is only “possible”, then a
sensible physician — in contrast to a jury in a court of law, which may
feel obliged to come to a definitive final opinion based on less than
substantial evidence — simply assumes an agnostic position with respect to
the anecdotal evidence while awaiting further suggestive evidence. A EBM
practioner does not feel impelled to come to a definitive conclusion
(either for, or against a particular position) if the evidence is
inconclusive. EBM is like completing a crossword. EBM evidence is only
deemed solid when all the clues are solved and when all the interlinking
answers are consonantly linked together in an incontrovertible
(unfalsifiable) fashion. If only some of the clues are answered, and one
cannot perfectly interlink all the answers in a satisfactory manner, then
a prudent physician simply adopts an agnostic position while awaiting
further clue-solving attempts. A prudent physician does not feel impelled
to come to a definitive conclusion based on inadequate, or contradictory,
evidence. The author seemingly argues that one should come to a defintive
conclusion even if the anecdotal evidence is unsubstantial, or otherwise
incomplete.
3) The author states-: “Hence, the evidence of 1000 plus sets of
parents in the MMR cases backed by before and after video, photographs and
medical records, ought to be considered by a court in preference to the
science. However, it seems that is not happening as it should. Whilst
scientific opinion evidence ought to play second fiddle to the oral
witness evidence, it takes pride of place and forces the oral witness
evidence into the shadows.”
The author seemingly suggests that anecdotal evidence from 1,000
individual case reports ought to be considered in preference to the
results of medical science (EBM evidence). Again, he seemingly implies
that those 1,000 case reports exist in a separate “universe” outside the
field of EBM evidence, and he even believes that the “anecdotal evidence”
should be given preferential treatment to other forms of EBM evidence. I
think that this opinion reflects the author’s bias, and that it represents
a misunderstanding of what constitutes EBM evidence. Those 1,000 case
reports are part-and-parcel of what constitutes “EBM evidence”, and the
“EBM evidence” they provide should be weighted according to simple common
sense principles of probability (likelihood). Individual EBM practioners
may weigh the evidence from those 1,000 case reports differently, and they
may harbor varying degrees of agnosticism (scepticism) with respect to the
evidence, but no responsible EBM practioner would ignore, or totally
discount, the anecdotal evidence.
4) The author states-: “For issues of public safety, such as
medicines like MMR or vaccines in the Gulf War, or the BSE crisis, the
risk standard ought to be applied.”
The author seeminly wants to use the same standards of probability
(preponderance of evidence) as is applicable to a court of law, to public
policy. He therefore argues that a risk assessment should be made
regarding the use of MMR vaccination based on the preponderance of the
evidence. I partially agree with the author on this point. I think that
EBM practioners should weigh the “known” EBM evidence regarding the harms
of MMR vaccination (using the standard EBM “level of evidence” weighting
system) and balance the potential harms of MMR vaccination against the
potential harms of not vaccinating the entire population (decrease in herd
immunity to measles, mumps, rubella). The EBM practioner’s final, but
tentative, conclusion would be equivalent to a tentative completion of a
crossword. If a EBM practioner is unsure of his conclusion, he would
simply pencil in his answers, and he would only use indelible ink if his
final conclusion (final crossword solution) is deemed incontrovertible.
Many people may be convinced that their risk assessment regarding the
risks/benefits of MMR vaccination is worthy of a definitive conclusion and
they may feel that it is appropriate to use indelible ink when pronouncing
their opinions, but I think that they are wrong to condemn other EBM
practioners who choose to only pencil in their opinions because they have
come to a more tentative conclusion. I think that when the EBM evidence is
incomplete, that further scientific evidence should be actively sought by
performing more research studies eg. allowing a subsegment of the
population to choose not to have MMR vaccination and then assessing
whether there is a subsequent decreased incidence of autism (or allergies)
in that sample population compared to the control population of MMR
vaccinated individuals (during a finite period of time). Such case control
studies may allow the EBM evidence regarding MMR vaccination to reach a
higher level of EBM evidence, so that it may hopefully one day merit the
designation “reliably accurate”. In the meantime, I think that people
should avoid positing polarising opinions that are based on an inadequate
understanding of what constitutes EBM evidence.
Rapid Response:
In response to Clifford Miller's opinions on medical science
I have noticed that no responder has challenged the opinions
expressed by this author, so I have decided to personally respond to his
incompletely informed opinions.
Clifford Miller is critical of medical science, but I think that he
does not really understand how medical science works, and he does not
seemingly understand the foundational basis of evidence-based medicine.
1) The author states -: “The main reason medical science is
potentially to be considered flawed, such as in the legal arena is
because, it intentionally, necessarily (for its own purposes) and
systemically fails to take account of evidence which is fundamental to the
deliberations of a court. Reliable evidence is that which is authentic,
accurate and complete. In short, scientific evidence is incomplete if used
for purposes outside the strict confines of science because it fails to
take account of evidence of lay witnesses of the facts and is hence only
applicable to the narrow and specific confines of scientific enquiry and
not the broader ones found in other fields of human endeavour.”
This series of sentences seems to be the central tenet of the
author’s critical attack on medical science. He seemingly believes that
evidence-based medicine (EBM) does not consider anecdotal evidence from
individual lay witnesses (or individual physicians). He is obviously in
error, because all textbooks on evidence-based medicine discuss the issue
of the apparent reliability of scientific evidence, and they all recommend
using a grading system (classification system) to assess the scientific
reliability of the EBM evidence. The highest level of evidence is evidence
from multiple randomised controlled trials that have consistently positive
results. The EBM evidence is deemed less reliable if there is
inconsistency in the results of multiple randomised clinical trials, or if
the trials have a low signal/noise ratio. Case control studies are
accorded a lower level of evidence, and the lowest level of evidence is
the evidence obtained from single case reports (anecdotal evidence).
Although single anecdotal case reports are regarded as a lower level of
evidence, it does not therefore imply that the field of EBM ignores
anecdotal reports. It simply means that EBM will not regard anecdotal
evidence as being totally reliable if it is not proven to be “authentic,
accurate and complete” (author’s words).
2) The author writes-: “Science treats evidence of lay witnesses of
fact as inadmissible (as ‘anecdotal’ only) for reasons which are
inapplicable in Court, but science does so for two main reasons. The
higher scientific standard of proof (in effect, irrefutability) only
admits evidence which can be tested scientifically for reliability. Oral
witness evidence is discounted by medical science because medical
scientific method does not currently have or recognise a mechanism for
testing oral evidence to the scientific standard and so, for the sake of
rigour, excludes it.
Neither of these propositions apply in Court. Evidence of the direct
witness of the fact, whether oral, or more frequently now, by way of
written statement, is always admissible and is, in fact, the keystone of
the trial system of evidence and the primary source of information a court
uses to make decisions of fact. The Court has and applies its own
mechanisms for testing witness evidence (eg. cross-examination). Further,
the Court applies a far lower standard of proof, namely a balance of
probability and not the unnecessarily high one of irrefutability applied
by science.”
The author seemingly suggests that the science of evidence-based
medicine is faulty because it does not utilise the same common sense
standards that are applicable to a courtroom — where all types of
anecdotal evidence are permissible and where the testing of the evidence
occurs through the process of cross-examination, and where the jury’s
final opinion is based on the balance of probability (preponderance of the
evidence). Again, I think that the author does not understand how unbiased
EBM practioners view the font of EBM evidence. I think that sensible
physicians view the EBM evidence (all levels of evidence) by utilising the
same simple common sense principles of probability. If the EBM evidence is
only based on a series of anecdotal reports, a sensible, but unbiased,
physician does not totally discount the evidence. He simply accords it a
lower level of evidence, which can run through the entire gamut from
possible-to-probable. If the EBM evidence is only “possible”, then a
sensible physician — in contrast to a jury in a court of law, which may
feel obliged to come to a definitive final opinion based on less than
substantial evidence — simply assumes an agnostic position with respect to
the anecdotal evidence while awaiting further suggestive evidence. A EBM
practioner does not feel impelled to come to a definitive conclusion
(either for, or against a particular position) if the evidence is
inconclusive. EBM is like completing a crossword. EBM evidence is only
deemed solid when all the clues are solved and when all the interlinking
answers are consonantly linked together in an incontrovertible
(unfalsifiable) fashion. If only some of the clues are answered, and one
cannot perfectly interlink all the answers in a satisfactory manner, then
a prudent physician simply adopts an agnostic position while awaiting
further clue-solving attempts. A prudent physician does not feel impelled
to come to a definitive conclusion based on inadequate, or contradictory,
evidence. The author seemingly argues that one should come to a defintive
conclusion even if the anecdotal evidence is unsubstantial, or otherwise
incomplete.
3) The author states-: “Hence, the evidence of 1000 plus sets of
parents in the MMR cases backed by before and after video, photographs and
medical records, ought to be considered by a court in preference to the
science. However, it seems that is not happening as it should. Whilst
scientific opinion evidence ought to play second fiddle to the oral
witness evidence, it takes pride of place and forces the oral witness
evidence into the shadows.”
The author seemingly suggests that anecdotal evidence from 1,000
individual case reports ought to be considered in preference to the
results of medical science (EBM evidence). Again, he seemingly implies
that those 1,000 case reports exist in a separate “universe” outside the
field of EBM evidence, and he even believes that the “anecdotal evidence”
should be given preferential treatment to other forms of EBM evidence. I
think that this opinion reflects the author’s bias, and that it represents
a misunderstanding of what constitutes EBM evidence. Those 1,000 case
reports are part-and-parcel of what constitutes “EBM evidence”, and the
“EBM evidence” they provide should be weighted according to simple common
sense principles of probability (likelihood). Individual EBM practioners
may weigh the evidence from those 1,000 case reports differently, and they
may harbor varying degrees of agnosticism (scepticism) with respect to the
evidence, but no responsible EBM practioner would ignore, or totally
discount, the anecdotal evidence.
4) The author states-: “For issues of public safety, such as
medicines like MMR or vaccines in the Gulf War, or the BSE crisis, the
risk standard ought to be applied.”
The author seeminly wants to use the same standards of probability
(preponderance of evidence) as is applicable to a court of law, to public
policy. He therefore argues that a risk assessment should be made
regarding the use of MMR vaccination based on the preponderance of the
evidence. I partially agree with the author on this point. I think that
EBM practioners should weigh the “known” EBM evidence regarding the harms
of MMR vaccination (using the standard EBM “level of evidence” weighting
system) and balance the potential harms of MMR vaccination against the
potential harms of not vaccinating the entire population (decrease in herd
immunity to measles, mumps, rubella). The EBM practioner’s final, but
tentative, conclusion would be equivalent to a tentative completion of a
crossword. If a EBM practioner is unsure of his conclusion, he would
simply pencil in his answers, and he would only use indelible ink if his
final conclusion (final crossword solution) is deemed incontrovertible.
Many people may be convinced that their risk assessment regarding the
risks/benefits of MMR vaccination is worthy of a definitive conclusion and
they may feel that it is appropriate to use indelible ink when pronouncing
their opinions, but I think that they are wrong to condemn other EBM
practioners who choose to only pencil in their opinions because they have
come to a more tentative conclusion. I think that when the EBM evidence is
incomplete, that further scientific evidence should be actively sought by
performing more research studies eg. allowing a subsegment of the
population to choose not to have MMR vaccination and then assessing
whether there is a subsequent decreased incidence of autism (or allergies)
in that sample population compared to the control population of MMR
vaccinated individuals (during a finite period of time). Such case control
studies may allow the EBM evidence regarding MMR vaccination to reach a
higher level of EBM evidence, so that it may hopefully one day merit the
designation “reliably accurate”. In the meantime, I think that people
should avoid positing polarising opinions that are based on an inadequate
understanding of what constitutes EBM evidence.
Competing interests:
None declared
Competing interests: No competing interests