Failures of the therapeutic chain as a cause of drug ineffectiveness
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7395.895 (Published 26 April 2003) Cite this as: BMJ 2003;326:895All rapid responses
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Figueras and Laporte's editorial is a good summary of some of the
problems inherent in the current association between medical services and
the pharmaceutical industry. I feel that these problems are secondary
expressions of a more fundamental conflict.
Ever since I qualified in medicine in 1972 and to some extent even before
then I have been aware of the obtrusive presence of the marketing efforts
of pharmaceutical companies in the educational and practical aspects of
medical provision in the UK. From the ubiquitous provision of pens, note
pads and sundry knick knacks, to the financing of university and hospital
staff and departments, pharmaceutical marketing departments have permeated
the fabric of the NHS. The majority of doctors take the view that they
are happy to accept such gifts and that they are completely uninfluenced
by them. It seems unlikely that such effort and resources (usually well
in excess of the companies' research budgets) would be spent on them if
this were the case. Indeed companies spend a good deal of time and effort
in measuring the effects of marketing on their sales. It is hard to touch
pitch and remain undefiled.
There is an expectation on the part of both the profession and government
that the industry will pick up the costs for an ever expanding list of
educational and service needs. The pharmaceutical companies are happy to
do this provided that they can see the investment paying off. Simply put,
these gifts come with strings attached.
While some degree of promotional activity is to be expected, we have
reached a stage now where almost all post-graduate educational meetings
are funded to a considerable extent by the industry. The degree of
industry funding to clinical research has risen to the point where many
academic departments would be hard put to manage without. At a national
level the industry has been approached to contribute to projects related
to medical records and communications.
The regulatory authorities who were set up to police the activities of the
industry are now for the most part funded by fees paid by industry. This
means that their budgets rise and fall with the fortunes of the companies.
If applications for licences are unsuccessful then it is possible that the
assessors may find themselves financially penalised. The potential
consumers and users of the products thus licensed may feel that such an
assessor's judgement might not be totally partial.
This state of affairs stems from the application of a free enterprise
market model to areas of society which arguably are not best managed in
this way. The money which pharmaceutical companies disburse does not fall
like manna from heaven. It comes from the profits which they make when
patients and health services purchase their products. These purchases
are, or should be, guided by the learned advice of medical and other
professions. Is it really impossible to imagine a state of affairs where
the professions are able to fund their own ongoing educational needs from
the fees and income which they derive from pursuing their practice, the
costs being deducted from the prices of drugs and added to the fees of the
professions? Apart from anything else it would free the hands of those
arranging such education from the guiding hands and associated costs of
pharmaceutical companies. Similarly the regulatory and research
communities could find their support from social rather than industrial
funds.
I know that this sounds impossibly socialist in the Brave New Labour World
which we inhabit, but it might just prove to be to the advantage even of
the pharmaceutical industry itself.
Competing interests:
General Practitioner recently returned after 16 years working in pharmaceutical industry in various companiew where I have retained pension benefits. I also have a small holding of GSK shares.
Competing interests: No competing interests
The article by Albert Figueras and Joan-Ramon Laporte was thought
provoking. I feel that the practice of promoting profitable drugs for
inappropriate indications is more widespread in developing countries.
Readers may be surprised to learn that several 'New, magic' drugs find
their way into physicians prescriptions, long before post-marketing data
are known to them. As a practising geriatrician in a big Indian city, I
find it depressing that several new drugs, with sparse trial data in the
elderly population or without any post-marketing data are enthusiastically
used in the elderly patients by the doctors.
The major culprit seems to be lack of proper training and
communication from the academic depts in teaching hospitals, to the
General practioners in the community. Unfortunately, as it is pointed out
in the article, most of the continuing education programmes are sponsored
by pharma companies. It is rather difficult to avoid bias in these
meetings. One simple way to educate the doctors would be through the Web.
Free sites, monitored by good academic Institutes, offering Consensus or
position statements will be great help for doctors in developing
countries.
Competing interests:
None declared
Competing interests: No competing interests
..some contentious issues on the failure of the therapeutic chain ....
Professors Figueras and Laporte suggest that "clinical trials are
designed to evaluate drugs rather than patients or diseases". On the
contrary, after extensive preclinical evaluation, each "potential" new
drug has to go through a series of clinical studies to ensure it is safe
with acceptable tolerability on human. Furthermore, the new drug has to
demonstrate sufficient efficacy and effectiveness to treat those suffering
from the target diease prior to applying for market authorisation. Even
when the new drug is on the market, it requires continual drug safety
monitoring.
Although a 20-year patent is granted for a "potential" new drug, drug
development takes up to 15 years prior to market approval, with an
expenditure estimated around £400m. The pharmaceutical companies then have
to recoup this expenditure before the patent expires (i.e. around 5 years
after the market approval) and before generic competition
commences.However, not all "potential" new drugs will receive market
approval: only 1 out of 15 will eventually succeed during clinical
development. Moreover, not all market approved new drugs will generate
sufficient profits to recoup the investment made during drug development.
There is always a balance between academic interest and therapeutic
practicability. Owing to the restricted funding available within the
current economic climate, it would be more logical to rationalise drug
development towards therapeutic practice, rather than focussing solely on
the academic issue.
Competing interests:
The authors are currently working at a CRO specialising in early phases clinical studies
Competing interests: No competing interests