E-DRUG: Full Drug Trial Disclosure (4)
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Dear colleagues,
Professor Reidenberg's "notes for guidance" are very useful, but, again, the
problem
remains about who is to judge the scientific standard of the abstracts? I
know, that
both the US and the UK societies screen abstracts and will reject those
which are
substandard, but many journals and societies will not do so. On the other
hand,
even publication in a first-rate fully peer reviewed journal is no guarantee
for the
veracity of the data or their analysis.
Many years ago I discussed the problem with
Marcia Angell, the then editor of the New England Journal of Medicine, which
had
published two different large trial reports based on data which were
substantially
different from those submitted to the registration authorities, and leading
to a totally
different conclusion: There is no formal requirement to submit ALL basic
data, and it
would be an unnecessay burden for referees.
I am aware of one of the leading US
journals, which had - unwittingly - published a trial based on data
collected by eight
non-existing orthopaedic surgeons, but submitted by a large well known
foreign
company.
Even the Lancet once published a trial on a homeopathic medicine based
on flawed data. If one wants to cheat editors or referees there is
unfortunately
always a way to do so. As our calvinistic Dutch prime minister repeats over
and
over again, this is a question of "norms and values", and where huge sums of
money are involved such norms tend to be forgotten or at least pushed to the
background.
Best wishes,
Leo Offerhaus
Netherlands
offerhausl@euronet.nl
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