Dear Simon
I was interested to read your comments re in-built bias.
Coming from the pharmaceutical industry and now specialising in
providing EBM reports to it, I have to take issue.
Unfortunately, you have a presumption that anything emanating from the
pharmaceutical industry must be, by definition, biased at best, wrong at
worst.
In my experience, there is little point in the industry producing
erroneous reports. I say this for a number of reasons.
1. Much of the work that I currently do for industry is to examine the
current quality of treatments. There are a number of reasons for this:
firstly, there is little point in a company trying to develop a drug or
device for which there are already good products/devices available.
Secondly, the cost of developing a new drug and bringing it to market is
now estimated at around $800 million - a big number whoever you are -
and companies have responsibilities to themselves and their stakeholders
(including you and I) to ensure that money spent on research is done so
properly.
2. The 'beauty' of EBM work is that it goes a significant way to
reducing bias. I recognise that there is publication bias, i.e., until
there is a journal of 'negative results' there will always be a bias
towards publication of positive results. However, by allowing
meta-analysis we can go a significant way towards finding the 'truest'
results.
3. There is always the problem of trying to review older therapies in
the face of new alternatives and quite honestly, there is no easy way
round this. I think it behoves those seeking to introduce new therapies
to undertake good RCTs to prove their point.
4. Regarding the ethics of RCTs, I would consider the only purpose of
RCTs is to remove 'equipoise', i.e., where one is not able to make a
distinction between treatments on current evidence. This includes
studying new treatments v older modalities. Patients must give clear
informed consent to entry into clinical trials according to the
Declaration of Helsinki
I could go on and challenge each of the points but I am sure others will
jump in!
Dr Richard JM Phillips MBBS FFPM MBA
Principal and Managing Director
The Goffin Consultancy Ltd
Riding House,
Bossingham Road
Stelling Minnis
Canterbury, Kent CT4 6AZ
United Kingdom
Tel: +44 (0)1227 709220
Fax: +44 (0)1227 709721
Email: [log in to unmask]
Web: www.goffin-network.co.uk
Company number: 3699880
-----Original Message-----
From: Evidence based health (EBH) is the integration of individual
knowledge [mailto:[log in to unmask]] On Behalf Of
k.reese
Sent: Tuesday, May 07, 2002 9:06 AM
To: [log in to unmask]
Subject: SSED
Dear Simon
SSED is short for single subject experimental design.
Could I take the opportunity to respond to another point. Someone
recently questioned on the list whether aspects of therapy practice
should be funded by the uk nhs, because of it's lack of robust research.
I would like to make the following points.
1. In the UK, for many years (now slowly changing) it has been a closed
shop in terms of accessing research resources. Especially finances have
been gobbled up by predominantly the medics starving the therapies and
producing treatments, methods and reasoning which is only one groups
thinking. See the Culyer Report for details.
2. Medical research, or much of it, has an in built bias as it will
endorse either expensive drug therapy or procedures which benefit big
business. Regardless of what constraints are put in place this bias can
not be good for the truthfulness of the research. The therapies are less
invasive, generally do not promote a product and probably hence why they
have such poor funding.
3. The hypothetico-deductive model of working as proposed in such
systems as modern medical diagnosis/RCT has made some scary mistakes in
the past, almost experimenting on it's unwitting subjects/patients.
Examples include, the time it took to discover the lethal dose of
digoxin, fatalities in bilateral THR's and angiotensinogin in burns,
side effects of the contraceptive pill, the beauty of the RCT which was
phalidamide and the overuse of dangerous modalities such as X Rays and
antibiotics . The system still produces surgeons with the arrogance to
believe that is ok to knock up a hip prosthesis in his garage and put it
untested into a patient (actual case).
4. We must recognise that there are different ways of working. Many
therapists work on the why rather than the what basis. Eg yes the
diagnosis is impingment of the shoulder, but why has this
happened?. Treat the what without the why and it will just come back,
something that the simple diagnostic model repeatedly misses.
5. Science should be clinically led not academically. Clinicians should
ask the questions which the academics help to answer. Systems should not
be discarded because of the many reasons why the system is biased
against them. Modalities should be robustly tested prior to being
discarded for lack of robustness, as long as it is clear they are not
harmful.
8. I see time and time in research the mixing up of clinical and
statistical significance, encouraged by the simplisity of the RCT.
7. Finally it should be remembered that techniques such as
massage/manipulation, acupuncture are very old medicines way pre dating
antibiotics, X Rays etc. It is only recently that the establishment in
medicine have relaxed their monopoly and helped and accepted much of the
research is which is now proving the efficacy of these treatments.
Sorry if this sounds confrontational, it is not my intention
Regards Kevin Reese PT UK
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