Biological Plausibility

4/21/2020 Biological plausibility - Wikipedia
Biological plausibility
In epidemiology and biomedicine, the term biological plausibility refers to the proposal of a
causal association — a relationship between a putative cause and an outcome — that is consistent
with existing biological and medical knowledge.
Biological plausibility is one component of a method of reasoning that can establish a cause-and-
effect relationship between a biological factor and a particular disease or adverse event. It is also an
important part of the process of evaluating whether a proposed therapy (drug, vaccine, surgical
procedure, etc.) has a real benefit to a patient. This concept has application to many controversial
public affairs debates, such as that over the causes of adverse vaccination outcomes.
Biological plausibility is an essential element of the intellectual background of epidemiology. The

term originated in the seminal work of determining the causality of smoking-related disease (The
Surgeon General’s Advisory Committee on Smoking and Health [1964]).
Contents
Applications
Disease and adverse event causality
Treatment outcomes
References
Applications
Disease and adverse event causality
It is generally agreed that to be considered “causal”, the association between a biological factor and a
disease (or other bad outcome) should be biologically coherent. That is to say, it should be plausible
and explicable biologically according to the known facts of the natural history and biology of the
disease in question.
Other important criteria in evaluations of disease and adverse event causality include consistency,
strength of association, specificity and a meaningful temporal relationship. These are
known collectively as the Bradford-Hill criteria, after the great English epidemiologist who proposed
them in 1965. However, Austin Bradford Hill himself de-emphasized "plausibility" among the other
criteria:
It will be helpful if the causation we suspect is biologically plausible. But this is a feature I
am convinced we cannot demand. What is biologically plausible depends upon the
biological knowledge of the day. To quote again from my Alfred Watson Memorial
Lecture [1962], there was
"…no biological knowledge to support (or to refute) Pott’s observation in the 18th
century of the excess of cancer in chimney sweeps. It was lack of biological
knowledge in the 19th that led to a prize essayist writing on the value and the
fallacy of statistics to conclude, amongst other “absurd” associations, that 'it could
https://en.wikipedia.org/wiki/Biological_plausibility 1/2
4/21/2020 Biological plausibility - Wikipedia
be no more ridiculous for the strange who passed the night in the steerage of an
emigrant ship to ascribe the typhus, which he there contracted, to the vermin with
which bodies of the sick might be infected.' And coming to nearer times, in the 20th
century there was no biological knowledge to support the evidence against
rubella."
In short, the association we observe may be one new to science or medicine and we must
not dismiss it too light-heartedly as just too odd. As Sherlock Holmes advised Dr.
Watson, "when you have eliminated the impossible, whatever remains, however
improbable, must be the truth."[1]
Treatment outcomes
The preliminary research leading up to a randomized clinical trial (RCT) of a drug or biologic has
been termed "plausibility building". This involves the gathering and analysis of biochemical, tissue or
animal data which are eventually found to point to a mechanism of action or to demonstrate the
desired biological effect. This process is said to confer biological plausibility. Since large, definitive
RCTs are extremely expensive and labor-intensive, only sufficiently promising therapies are thought
to merit the attention and effort of final confirmation (or refutation) in them.
In distinction to biological plausibility, clinical data from epidemiological studies, case reports, case
series and small, formal open or controlled clinical trials may confer clinical plausibility. According
to the strictest criteria, a therapy is sufficiently scientifically plausible to merit the time and expense
of definitive testing only if it is either biologically or clinically plausible.[2] It has been observed that,
despite its importance, biological plausibility is lacking for most complementary and alternative
medicine therapies.[3]
References
1. Hill, Austin Bradford (1965), “The Environment and Disease: Association or Causation?” (http://w
ww.edwardtufte.com/tufte/hill), Proceedings of the Royal Society of Medicine, 58, 295-300.
2. Hoffer, L. John (2003), “Complementary or alternative medicine: the need for plausibility” (http://w
ww.cmaj.ca/cgi/content/full/168/2/180), Canadian Medical Association Journal; 168 (2) [January
21 issue].
3. Hoffer, Op. cit.
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4/21/2020 Biological plausibility - Wikipedia

Biological plausibility is an essential element of the intellectual background of epidemiology. The

Disease and adverse event causality

Retrieved from "https://en.wikipedia.org/w/index.php?title=Biological_plausibility&oldid=924523195"

This page was last edited on 4 November 2019, at 10:55 (UTC).

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