(Date published: 26 February
2004)
By Alan Jones
of ajc
healthcare
If it slipped you by, a White Paper on genetics was
published in the middle of last year. The NHS appears to have woken up, says
Alan Jones.
Advances in genetics and genomics still continue to receive
a very high press profile. The reasons are not hard to find. 2003 marked the
fiftieth anniversary of Crick and Watson's ground-breaking discovery of the
structure of DNA and it was also the year in which the sequencing of the human
genome - the blueprint of life - was finally completed. The complete map of our
chromosomes was elucidated for the first time.
Advances in genetics and
genomics will hugely impact on drug development. But they will also hugely
impact on the National Health Service. Our inheritance, our future - realising
the potential of genetics in the NHS was published in 2003 - a three-year
strategy aimed at developing genetics knowledge, skills and provision within
the NHS. It also proposes new initiatives to introduce genetics-based
healthcare in the primary care sector and gene therapy research on single-gene
disorders like cystic fibrosis (www.doh.gov.uk/genetics/whitepaper.htm).
The
international pharmaceutical and biotechnology industries are, of course, at
the forefront of research into pharmacogenetics and pharmacogenomics - or the
field of targeted medicine. Thus, in a sense, the proposed Government
investment outlined in the White Paper is dwarfed by the resources already
being directed towards such research by the bio-pharmaceutical industry, which
has been recognised by the Government as 'farsighted investment.' But the
Government is also a little worried that these resources are mainly focused on
innovative new products that may not be marketed for several years. To try and
secure earlier benefits for NHS patients, the Department of Health has proposed
in its White Paper to invest up to £2.5m in pharmacogenetics research on
existing medicines, which patients are commonly taking now, or are likely to be
taking soon. And the Government would now like to see close collaboration
between NHS clinicians, academia and private industry in running pilot studies
for pharmacogenetic testing within the NHS aimed at the better prescribing of
marketed drugs in areas like hypertension and contraception. This is also to
help improve the usefulness of some marketed medicines, where effective
clinical outcomes may be significantly reduced by genetic-based toxicity which
is currently not possible to predict. To boost this research effort still
further, note that funding will be provided to set up the first University
Chair in Pharmacogenetics, supported by a small department.
Other
developments likely, and these are described in the White Paper, include
formation of an enlarged evidence base in this area. For example, the National
Horizon Scanning Centre will be including genetics in its regular programme of
work and the National Genetics Reference Laboratories will undertake health
technology assessments, as will the NHS R&D;Health Technology Assessment
programme. In addition, the National Institute of Clinical Excellence will be
asked to consider developments in genetics as the evidence base grows. So far,
so good - a certain theme is developing here, but now let's bring in another
couple of important issues. Although many of these technologies may still be
some way off, it is important that NHS managers, payers, and both national and
local policymakers, build some knowledge of what is in store for them. Do these
new technologies and their eventual products need some 'market access-like '
activities perhaps? Is it too early? Such innovations will no doubt come at a
high cost for health services across the UK and commissioners will want to
carefully manage their introduction when they do arrive. The key issue, then,
has to be about whether NHS commissioners will be willing to pay (or not!) the
inevitably high price for such new technologies. If that is likely to be the
case, does this area need 'seeding'? And who should deliver such messages to
NHS key opinion leaders? There is a new technical language here full of jargon
and quite impenetrable to lay observers.
In the December 2003 issue of
PharmaTimes, I discussed the large amount of 'baggage' within the NHS and the
real need to try and improve relationships with health service customers. It
would, of course, be most beneficial for NHS managers to really understand how
the Industry works, and I think the advances in pharmacogenetics represents a
superb opportunity to prepare the ground, examine general market access
activities and to improve relationships with NHS customers.
But maybe
there is a right way and a wrong way of going about this. In what is being
compared to jeweller Gerald Ratner's famous comments about his company's 'crap
products,' perhaps GlaxoSmithKline's vice president of genetic research, Allen
Roses, should have been more careful about what he said at a scientific meeting
last year that the 'vast majority of drugs only work in 30-50% of people.' This
was reported on the front page of The Independent newspaper under the title,
'Drugs don't work'… triggering a fall in GSK's share price. While clearly
what Dr Roses said was true, and he was obviously trying to prepare folk for
these breakthroughs in pharmacogenetics, it's the way you tell 'em!
There is no doubt that greater understanding of human genetics,
genomics and proteomics will lead to new drugs and novel therapies. It will
particularly allow the development of gene-based drugs and treatments targeted
at the disease-causing fault rather than control of symptoms. An example often
given is gene therapy, which is the deliberate introduction of genetic material
into a patient's cells to treat diseases. At the current rate of development,
it is expected that we will see the first licensed gene therapy medicines
coming on stream within five to ten years. In the longer-term, gene therapy may
become a cornerstone of modern medicine, moving treatment from palliative care
to curative care. This is revolutionary stuff. Such new technological advances
have the potential to provide huge benefits for patients, but will they provide
a universal panacea or open up a Pandora's box of issues? We are already seeing
a significant fall in confidence and lack of trust in scientific 'experts'
following the BSE and GM 'crises'. It would be a terrible travesty if, in the
future, after all the research and the development invested, the public refused
their use and judged them instead to be 'Frankenstein' drugs. If the future is
digital and pharmacogenetical… does the Industry now need to start
preparing the ground, not only with NHS managers and with clinicians, nurses,
pharmacists but also with patients and the general public?… The NHS is
gearing up for the New World of genetics, the question is are you?
The
article was first published in the
Pharma Times: February
2004
About the author
Alan Jones
is an independent health policy analyst and adviser. He writes and presents
widely on the New NHS. Alan spent some 20 years in the Pharmaceutical Industry
in a variety of sales, marketing and business development roles including some
10 years at Glaxo Wellcome UK where he was responsible for relationship
building between Glaxo Wellcome and the Department of Health, and in developing
a corporate understanding of current NHS policy initiatives and their likely
implications and impact on the business.
Alan is also managing
consultant at ajc healthcare, which specialises in NHS policy issues for both
the Pharmaceutical Industry and the NHS and aiming to support organisations in
steering the right strategic course through a rapidly changing NHS
environment.
Alan has a Masters in Business Administration and is a
fully qualified teacher - before joining the Pharmaceutical Industry, he spent
a decade teaching and lecturing in colleges, schools and universities in the
UK, the United States and West Africa. He is also a reviewer with the NHS
National Co-ordinating Centre for Health Technology Assessment (NCCHTA) and was
a member of the UK Local Organising Committee for the International Society for
Technology Assessment in Health Care (ISTAHC) held in Edinburgh in June
1999.
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contact Alan Jones
