APPENDIX 22
Memorandum from the King's Fund (PI 81)
The King's Fund is an independent health charity.
In our report Getting the Right Medicines, published in December
2003, the Fund argued that the interests of the pharmaceutical
industry had too great an influence on the NHS, mainly because
the mechanisms for asserting the public interest in the development
of medicines was too weak. We argued that new forms of public/private
partnership were required in which the public interest would be
given greater weight and that the Department of Health should
aim to create a level playing field, by appropriate research commissioning
policies, between drugs and other forms of treatment.
In this memorandum, we develop this argument
by focusing on a particular type of health need, those with chronic
conditions. Patients with chronic conditions represent the ideal
market for the pharmaceutical industry, but the nature of their
interest means that only certain fields are investigated and that
innovation is biased towards new drugs rather than a search for
preventive measures and pays too little regard for other issues
such as the long term impacts of specific drug regimes, interactions
between drugs for multiple conditions, drug safety, adverse drug
reactions, and alternatives to drugs such as diet or other behavioural
modification (unless these are considered to be achievable by
drug regimes). This bias stems directly from the fact that the
companies are focused on only one part of the potential therapy
spectrum.
Furthermore not all long-term conditions are
commercially attractive either because the markets they represent
are too small or the scope for new drugs is limited for scientific
reasons.
The following comments relate to the headings
set out in the Committee's request for evidence.
DRUG INNOVATION
The conduct of medical research
These can be taken together. The key issue here
is the selection of topics for investigation. As noted above,
there are many areas which are not of interest to the industry.
Unless the public health interest is clearly articulated and appropriate
action taken, these will continue to be neglected.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
Professional and patient education
These two areas can be taken together. The central
issue is the balance and objectivity of the information available
to the patient and the professional. As things presently stand,
the resources available for promoting commercially profitable
drugs are much greater than those available for promoting alternatives—ie
out of patent or generic drugs or other forms of treatment including
cognitive and behavioural therapies.
The NHS has made significant strides in redressing
the balance through local formularies, NHS direct online, support
for systematic reviews, establishment of NICE etc. But it has
not given substantive support to establishing the effective use
of pharmaceuticals in practice within the populations to which
they are actually applied which may be very different from those
within which they have been trialled or evaluated.[77]
In the absence of such research, both professionals
and patients will remain poorly informed about the consequences
of some of their decisions to redress this situation would require
trials of drugs in use as opposed to the artificial circumstances
of the trials conducted for regulatory purposes. The point also
applies to the current policy of encouraging a switch of drugs
such as statins from prescription only status to P or GSL status,
the long-term consequences of which may or may not be beneficial.
REGULATORY REVIEW
OF DRUG
SAFETY AND
EFFICACY
Product evaluation
These two areas can be taken together. Ensuring
safe and effective treatment of chronic disease requires a long
term monitoring and evaluation regime.
The existing requirement for licensing drugs
do not entail a requirement that they should be shown to be more
cost-effective than existing drugs nor that their long-term effects
should be monitored by those seeking the licences. The recently
extended yellow card system provides an important source of information,
but this is not adequate for detecting all effects of this kind
in a systematic way.
To overcome this deficiency requires a fundamental
re-assessment of the role of the regulatory system, designed to
place greater emphasis on its role after licensing. Recent changes
to the yellow card scheme represent a first step in that direction,
but this needs to be supplemented by more systematic long-term
monitoring and evaluation. The recently reported study[78]
of hospital admissions arising from adverse drug reactions makes
the point that drugs can be dangerous to health whatever their
regulatory status.
Policy Recommendations
The basis for any policy recommendations must
be an agreed view of how the drug development process should work
in the public interest. We propose it should be part of what we
term a therapy development process, which in outline would look
like the following:
The diagram has been deliberately drawn in a
simplified form but it is sufficient to bring out some key points:
First, some needs including the needs of particular
patient groups, are not identified and there is no systematic
mechanism for identifying them.
Second, there is no mechanism for considering
the balance of research effort over the whole health field. This
would require not only the capacity to survey what research is
or is not being done but also the capacity to commission work
in areas found to be neglected.
Third, the current set of arrangements do not
ensure a level playing field between different research and treatment
options. The full range of options is not considered because the
private sector is restricted by profit considerations and the
public sector does not systematically seek to complement it.
Fourth, the current system is front loaded ie
the balance of resources is heavily biased towards the new, rather
than the effective use of the existing. The resources going in
the later stages, particularly the final one, are small relative
to those going into research into new therapeutic options and
then subsequently into marketing them to health professionals
and individuals. Therefore investment doesn't necessarily match
potential health benefit.
Within the framework suggested by the diagram,
there is scope for different divisions of work. The industry could
continue to work as now and the public interest could be pursued
in a variety of ways, depending on what kind of partnerships can
be developed between government and industry. Alternatively the
role of the industry could be modified through the introduction
of an expanded regulatory and monitoring regime designed to deal
with the issues raised above about effective and safe drug usage
and the alternatives to drug regimes.
We do not wish to propose any particular kind
of partnership or new regulatory regime. What we do recommend
is the Department of Health acknowledges that the existing set
of arrangements do not work as well as they might in the public
interest. The recent announcement of a research collaborative[79]
is a step in the right direction as is the recognition, in the
announcement, that there are important gaps in existing public
and private research programmes. The next step is for the Department
to lead a substantive study of what we have termed the therapy
development process of which the drug development process forms
part.
We would like to see the new Director of R&D
set out a broad strategy as to what the role and use of NHS R&D
funds should be, based on what we see as the failures of the health
research economy on the one hand and NHS principles on the other.
This should consider the need to apply a set of criteria which
are not simply based on the major diseases but which take into
account a wider range of considerations including equity, the
potential for improved quality of life and the scope for patients
to take care of their own condition(s), with or without the use
of drugs.
77 BMJ 2004 nsaid. Back
78
BMJ 2004 329 15. Back
79
Department of Health PR2004/XXX. Back
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