Letter to the editor
March 25, 2014
It is with surprise that we read
the comments by ASMI director
of scientific affairs, Steve Scarff,
down playing the recent publication
of research results by letter in
the world’s number one medical
journal The New England Journal
of Medicine [Atkinson HC et al
Increased Phenylephrine Plasma
Levels with Co-Administration of
Acetaminophen: New England
Journal of Medicine (2014) 370:12,
1171-2].
It is difficult to see how a
previously unknown drug-drug
interaction which underpins
the regulatory rules around
paracetamol and phenylephrine
combinations is somehow
unimportant. Furthermore there
is an attempt to further downplay
the results by virtue of them being
published in a letter.
It is important to note that a
letter to the journal is still subject
to editorial and peer review prior
to publication. A letter is often seen
as a mechanism to make important
scientific results available in a
timely manner since publication is
more rapid.
We also note that many of the
member companies of ASMI were
pivotal drivers behind an extensive
and thorough scientific document
summarising the state of expert
published and industry unpublished
knowledge on phenylephrine which
was tabled in the USA.
The conclusion of this document
was “oral phenylephrine 10mg
is safe and effective as a nasal
decongestant for over-the-counter
use in adults” and that “there are
insufficient data in adults to support
the assertion that increasing the
dose of phenylephrine to 25mg
is necessary to produce clinically
meaningful improvements in nasal
decongestion with a similar safety
profile as the currently available
10mg OTC monograph dose.”
Here is a discovery that shows
that combining phenylephrine with
another drug effectively doubles
the amount of phenylephrine
in a person’s system – precisely
the outcome these multinational
pharmaceutical companies did not
want in their submissions to the
US Food and Drug Administration
- yet the response of their industry
body in Australia is to describe the
research as being of “limited value”.
This seems to be at odds with their
own member’s collective scientific
knowledge.
Hartley Atkinson M.Pharm, PhD
We welcome any comments - if
you would like to weigh in on this
or other subjects, email us at
info@pharmacydaily.com.au.
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