August 2005 - Association of Dutch Businessmen

REVIEW
Myths and facts about medicine
Review of presentation of Taco van Tiel at the Hollandse Club at 17 May 2005
By Debby Reemers
Why would an increased risk in getting breast
cancer by 30% for a certain medicine not be a
reason to stop producing it? The questions from
the audience for Taco van Tiel are not at all the
easiest to answer. By nature the pharmaceutical
industry has always been surrounded by
controversy. A company making its profit on
supplying expensive medicine to sick people: the
topic will always remain a highly intricate and
tricky one. Still though, Taco van Tiel regional
marketing and sales manager at Organon, not only
managed to show us an in-depth view from the
industry point of view he also presented a lot of
interesting research results and other related issues
on the pharmaceutical industry to an interested
and critical audience at the Hollandse Club.
Van Tiel concentrated on three main subjects
to address the broad topic of ‘Myths and Facts
about Medicine’
- The perception versus reality of doing business
in the pharmaceutical industry;
- How does Singapore (Asia) differ from Western
Europe and the USA;
- Building brands in the pharmaceutical arena.
This article will highlight the first and second
topic as these were more elaborately discussed.
Perception versus reality
Pharma companies will market drugs despite the
fact they know they are potentially harmful. Most
drugs are dangerous, you can read it in the papers
every day! According to Van Tiel, this is the most
common misunderstanding that people have on how
companies like Organon operate. He explains about
the extensive research procedure a drug has to go
through before it even gets to the FDA for final
approval. From an independent study in 2003 by
Drug Discovery Today (December 2003) on several
leading pharma companies it was concluded that
on average only 1.2 out of 57 projects that result
from a ‘discovery’ would make it through the drug
registration phase by the drug regulating authority,
after which only 1 project on average actually
gets launched. In fact, during the internal clinical
trials 90% of all research projects are already
stopped during the first (out of the total of 4)
clinical development phase. The quality of research
projects in the U.S.A., the most important market
for Organon, is continuously monitored by the
independent U.S. Data and Safety Monitoring
Board. If a project does not adhere to their
standards, the research project is stopped. Van Tiel
adds, that Organon is one of the few pharmaceutical
companies that continues testing its products after
the launch, unlike its main competitors.
The controversy of certain medicine and the
way media reports on them is illustrated by a drug
used in Hormone replacement therapies (HRT) with
the name of Tibolone. This HRT drug helps women
to soften the symptoms of the menopause which
includes hot flushes and night sweats. The drug
also helps to strengthen the bones. Media reported
headlines such as ‘600,000 women warned to stop
taking combined HRT medicines’, therewith
inciting what Van Tiel calls a ‘hormonophobia’.
These headlines were based on a global study called
‘Million Women Study’ (MWS), as published by the
British medical journal ‘The Lancet’ in March 2005.
The MWS claimed a 30% increase in the risk for
breast cancer when using HRT. Van Tiel explains
why the results from this study are not fully valid.
The study is a so called observational study, as
opposed to a clinical trial. Observational studies
do not make use of placebos (i.e. sugar pills with
no active ingredients) which means they lack
control groups. As a result you will not know how
many of participants would have gotten cancer
while using a placebo in stead of the tested drug.
The lack of a controlled environment also causes
other research problems. In the case of the MWS,
several women stopped using the drug during the
trial, took the drug on an irregular basis, or even
switched drugs. In addition, the MWS test group
was already seeing the General Practitioner (GP)
for particular hormone related symptoms. Possibly
this group of women is anyhow running a higher
risk on developing breast cancer than a randomized
group of women. Therefore such group cannot
be considered representative for the general
population of the UK. Several national authorities
have publicly questioned the results of the MWS
based on the above mentioned limitations. Still
though, the media seem to take these studies out
of their contexts and turn these into unsubstantiated
headlines. A possible negative effect resulting
from this could be that potential beneficiaries
from medicine will not make use of HRT and
other ‘demonized’ medicines. There are also other
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Vol.15 • No. 6 • July/August 2005