APPENDIX 31
Memorandum by the Medicines Commission
(PI 112)
1. INTRODUCTION
1.1 The Medicines Commission is grateful
for the opportunity to give its views on the "Influence of
the Pharmaceutical Industry" to the Health Select Committee.
1.1.1 The Commission was established under
Section 2 of the Medicines Act 1968. Its general function is to
advise "the Ministers" (ie the Secretary of State and
the Northern Ireland Departments for health and agriculture)
"on matters relating to the execution of this Act or the
exercise of any powers conferred by it, or otherwise relating
to medicinal products, where either the Commission consider it
expedient, or they are requested by the Minister or Ministers
in question to do so". The Commission is fundamental to the
working of the Act, and in addition to its general function was
established to provide advice to the "licensing authority"
under section 6 of the Medicines Act 1968 (consisting of the Secretaries
of State for Health and Environment, Food & Rural Affairs,
and the Northern Ireland Departments for health & agriculture)
on matters relating to the licensing of medicines.
The Commission also have a duty to make recommendations
to the Ministers on the number and functions of committees to
be set up under Section 4 of the Act, such as the Committee on
Safety of Medicines (CSM) and the Veterinary Products Committee
(VPC), and on suitable members of such committees.
1.1.2 An important additional function of
the Commission is to act as an appellate body for human and veterinary
use marketing authorisation applications that have been refused
by the licensing authority on advice from the CSM and VPC. In
such cases, applicants have a right to make representations to
the Commission; the licensing authority must consider the Commission's
findings and advice before deciding whether to confirm or alter
its original decision. The Commission also considers cases where
the licensing authority proposes to revoke or suspend a marketing
authorisation, or impose a variation to such an authorisation,
following advice from CSM and VPC.
1.1.3 The Act requires that the Commission's
members should include at least one person with experience and
capacity in each of the following: practice of medicine; practice
of veterinary medicine; practice of pharmacy; chemistry other
than pharmaceutical chemistry; and the pharmaceutical industry
(currently two members). In its current constitution, the Commission
has some 24 members with a broad range of expertise. It also includes
lay members, complementary medicine practitioners, microbiologists,
nurses, statisticians, and hospital, university, and primary care
doctors. All Commissioners are appointed on the basis of their
individual expertise and bring diverse perspectives. The Commission
provides an independent overview and meets approximately five
to six times per year; members are appointed for four-year terms.
1.2 At its November meeting the Commission
considered in detail the Health Select Committee's Inquiry on
the "Influence of the Pharmaceutical Industry". The
Commission welcomed the inquiry and felt that this was an appropriate
time to re-consider the roles and influences that pharmaceutical
companies have on medicines, medicines innovation, and health
care in general.
In making the following comments the Commission
was conscious of the rapid changes in public and professional
access to, and the use of, medicines, and the need to be imaginative
and thoughtful about the potential for restructuring the relation
between policy makers, industry and health professions. It has
attempted to draw on the diverse views and expertise of Commissioners
by stepping back from preconceptions of health and industry relations,
and questioning where and why the imbalances between health policy
objectives and industry occur, and what can be done to improve
them for public benefit.
The Health Services and Pharmaceutical Industry
1.2.1 The Health Select Committee inquiry
should be viewed positively, for its potential to provide advice
on restructuring the relationship between policy makers, regulators,
industry, consumers, and all health professionals. The range of
consumers and health professionals directly involved in day to
day medicines management has increased and will continue to do
so as switches to over the counter (OTC) drugs continue, and nursing
and allied health professionals are incorporated into prescribing
and policy making activities.
1.2.2 There is a perceived imbalance between
the objectives of the industry and those of health care. The Inquiry
will want to look widely and constructively at what are considered
to be the real issues, rather than mere perceptions. The extent
to which the ultimate objectives of health services and industry
are disparate need to be considered, and ways they may best work
together need to be explored.
1.2.3 In the current changing climate it
is imperative that accountability, openness, transparency, and
public participation are promoted on both sides. It is critical
that the development and planning of policies that are credible,
fair, and practical should involve players who are independent
of government, industry, and special interest groups.
1.2.4 All stakeholders in health care have
vested interests. The influence of pharmaceutical companies needs
to be seen alongside the interests of the state (to provide comprehensive
health care while controlling costs), patient groups (to get their
specific problem dealt with quickly and safely), professionals,
news media, and politicians. All these interest groups exert an
influence, which can sometimes be excessive, producing an unbalancing
and possibly damaging effect. Transparency and balance are key.
1.2.5 The current problems with the influence
of pharmaceutical companies are well recognised. They include,
for example, the lack of transparency of research data, distortion
from publication bias, excessive delays before responding to reports
on adverse effects, and inaccessibility of information about patients
who have taken part in clinical trials. The possible availability
of information from a wide range of sources on the web means that
restricting information on drugs would no longer be possible.
A useful approach would be to create a trusted reliable kite mark
for information that is well researched and evidence-based, to
run alongside information from special interest groups and those
promoting particular information.
— Creation of a reliable kite mark
for evidence-based information.
1.2.6 In recognising the major issues, we
also note that problems would be much worse without the current
regulatory systems. Tackling these issues is not just about more
regulation, but about changing the nature of regulation and other
aspects to fit modern needs better. This includes identifying
the wide range of health professions and researchers engaged in
the processes more systematically, as well as the roles of consumers.
For example, the increasingly important and welcome engagement
of patient groups makes it essential to have a strategic approach
to them. Consideration should be given to the setting up of an
umbrella body to promote good practises in prescribing, supply,
and administration of medicines, and to consider other aspects,
such as funding arrangements.
— An umbrella body to promote good
practises in prescribing, supply, and administration of medicines.
Definitions
1.3 The phrase "pharmaceutical industry"
requires more precise definition. There are many different types
of pharmaceutical companies, ranging from so-called "Big
Pharma" at one end of the spectrum (eg large multinational
companies) to small local generics companies at the other. Biotech
companies and manufacturers of herbal and homoeopathic medicines
form other distinct groups. Furthermore, within each company there
is a range of activities that need to be carefully distinguished,
from high quality science at one end of the spectrum to marketing
activities at the other. A scientist in a company working at the
academic end of drug innovation and therapy will have no influence
over the marketing activities of the company. It is the activities
of those working in the marketing divisions that determine how
drugs are marketed and presented to health care workers and the
public.
1.3.1 It will be important, whatever measures
are recommended, to recognize the complexity of pharmaceutical
companies, and to ensure that recommendations that are targeted
at one sector of pharmaceutical activity will not damage another.
1.3.2 It will be particularly important
not to threaten the continuance of basic scientific research that
pharmaceutical companies foster, often associated with universities.
An index of the success of industry research is that several Nobel
Prize winners won their prizes for work that was carried out while
they were working for pharmaceutical companies. Examples include:
Gerhard Domagk, 1938, for discovering sulphonamides; Paul Mller,
1948, for discovering DDT; John Vane, 1982, for his work on prostaglandins
and the mechanism of action of aspirin; James Black, 1988, for
discovering beta-blockers (and, later, histamine antagonists);
Gertrude Elion and George Hitchings, 1988, for their work on differences
in the structures and actions of normal and abnormal cells).
2. DRUG INNOVATION
2.1 As health service providers and consumers,
we are in need of innovative drugs to treat new, as well as current
diseases and to improve the quality of lives. It is notable that
the influence of the pharmaceutical industry has been positive
in the development of new products in a way that no state controlled
system has been able to match. Over the years there have been
numerous examples of this: ACE inhibitors and angiotensin receptor
blockers in reducing mortality in heart failure, statins in preventing
heart attacks and strokes, and sildenafil for erectile dysfunction.
We need new methods of encouraging the production
of innovative drugs by both academe and pharmaceutical companies,
both separately and also in concert. Mechanisms should be established
in order to encourage this.
— Development of methods to encourage
the production of innovative drugs.
2.1.1 Over the last few years there has
been a dramatic reduction in the numbers of new molecular entities
being submitted to licensing authorities. There has also been
a reduction in the number of entities being awarded licences.
Figures recently published by the US Food and Drug Administration
(FDA) show that the numbers of new licence applications submitted
to them fell from about 70 per year in 1993 to under 15 in 2003
[1]. The reasons are complex, but in their report the FDA point
to the fact that "the applied sciences needed for medical
product development have not kept pace with the tremendous advances
in the basic sciences". They partly blame the way in which
the reductionist approach, "knowledge at the gene, gene expression
or pathway level" has been fostered at the expense of the
systems approach, and they call for "strengthening and rebuilding
[of] physiology, pharmacology, [and] clinical pharmacology".
In other words, research on the gene and genome, necessary though
it is, has driven out research on the functioning of body systems,
to the detriment of innovation in drug therapy.
2.1.2 In the UK, the Higher Education Funding
Council's University Research Assessment Exercise (RAE) has put
more emphasis on reductionist research at the expense of systems
research, and this may have fostered the decline. The increasing
closure and contraction of some university science departments
is possibly a sad reflection of this process. This imbalance needs
to be redressed by fostering attitudes that value systems-based
research and by earmarking funds for functional research and the
revival of academic research in physiology and pharmacology.
2.1.3 Research performed in academic institutions
has a profound effect on drug innovation by pharmaceutical companies.
Although companies fund research in universities, for many years
now governments have spent twice as much on scientific research
as industrial companies. This was true in the 1960s [2] and is
true today [3].
2.1.4 Pharmaceutical companies have benefited,
and have been very effective, in using the results of research
from all sectors working in drug development. Often UK-based companies
fund research organisations abroad, where costs are cheaper. Companies
should be encouraged to divert more money into academic research
institutions in the UK than they currently do. Basic scientific
research institutes in the UK, perhaps jointly funded by universities
and pharmaceutical companies, should be developed, with appropriate
regulatory functions to ensure public credibility in research
findings and their applications.
— Development of basic scientific research
institutes in the UK perhaps jointly funded by Universities and
companies.
Funding research into adverse drug reactions
2.2 Funding for research into adverse drug
reactions (ADRs), an extremely important aspect of drug therapy,
has been impossible to find in the current research climate. Large
grant-giving bodies (such as the Medical Research Council and
the Wellcome Trust) do not fund such research, because it is not
at the "cutting edge". Equally, Universities tend not
to fund such research, largely because of the pressures of the
Research Assessment Exercise noted above. Pharmaceutical companies
provide little funding for such research, because they do not
perceive it as being in their interests to do so, although recent
events surrounding Vioxx (rofecoxib) have highlighted this deficiency.
2.2.1 The early discovery of adverse drug
effects would help a company in their decisions to proceed in
the development of a drug and in planning better methods of making
their drugs available with suitable monitoring. Early discovery
of adverse effects also allows companies to develop coping strategies
(as exemplified by the Clozaril-clozapine Monitoring Scheme [4]),
potentially leading to enhanced usefulness of drugs that might
otherwise be lost. Late discovery leads almost inevitably to the
need to withdraw the drug, at great financial loss (eg Vioxx-rofecoxib).
— Companies should be encouraged to
fund early research into the adverse effects of their drugs and
ways of predicting or avoiding them.
Underdeveloped Areas
2.3 Encouragement should be given to appropriate
drug development in areas that do not necessarily yield high financial
returns. Recent UK and EU developments, promoting good practice,
have provided incentives to research drugs for paediatric use.
This is a good example of a previously under-developed but critical
area of medicines research and use.
2.3.1 As a major purchaser of healthcare,
the NHS has still to maximise its influence on industry prices
and drug development. As we understand it, medicines in the UK
are more costly than in many other European countries, despite
the strength, centralisation, and negotiating ability of its public
sector health delivery.
3. THE CONDUCT
OF MEDICAL
RESEARCH
3.1 Within industry, there is an imbalance
between the over-powerful marketing divisions of pharmaceutical
companies and their scientific and medical divisions. Short-term
marketing plans concentrate on studies that will help to market
products. This has the advantage of reaping immediate rewards
and avoids the necessity of performing studies that may take time
and have the potential of raising difficulties. This is neither
in patients' best interests, nor in companies' own long-term interests
if harmful effects of products go undetected.
— All medical research in pharmaceutical
companies should follow the principles of research governance.
There should be consistent standards of quality, appropriate methods,
ethical review, and outside scrutiny.
3.1.1 There is a bias towards publishing
only positive data. This has a consequence on other agencies,
which must waste resources in repeating the same research.
— There should be a requirement to
publish all data, backed up by the compulsory trials register
that is due to be established in 2005. This should be at the heart
of any new approach.
3.1.2 Industry has been accused of medicalising
society, by promoting/creating new medical conditions with potential
for a strong consumer demand, but which do not have an evidence
base. This is likely to influence the drugs that are chosen for
future development at the cost of investing in well-established
needs.
— There should be careful scrutiny
of the conditions for which drugs are promoted.
3.1.3 Pharmaceutical companies, amongst
their other functions, support posts, grants and university departments,
Without this support, many departments would not be able to conduct
valuable research and would find it difficult to find funding
elsewhere. If this is felt to undermine the credibility of medicines
research then alternative sources of funding will have to be identified,
as it is critical to good practice that such research should continue.
However it must be recognised that the industry contributes approximately
£6.7 billion per annum to Britain's gross domestic product
and also about £12 billion in exports.
3.1.4 Pharmaceutical companies have also
played a significant role in funding conferences and in facilitating
meetings and workshops. This source of funding should be encouraged,
since consideration would need to be given to alternative sources
of funding if this funding were not available. However, suitable
controls should be exerted over the extent to which funding of
this sort allows companies to promote their products covertly.
3.1.5 There are many helpful functions that
the pharmaceutical industry performs for the improvement of healthcare
and the impact of these beneficial effects should be recognised.
For example, industry has played an important role in highlighting
issues of fraud in medical research by pursuing cases through
the General Medical Council.
3.1.6 The FDA in the USA audits pivotal
registration studies. Recently a section of the Medicines and
Healthcare products Regulatory Agency (MHRA) has undertaken studies
of Good Clinical Practice (GCP) and audit; this had been highlighted
in the Audit Commission's report on the old Medicines Control
Agency. Within most companies, there is a policy to audit clinical
studies actively, as it is crucial to them that their data are
robust. This is perhaps not as well developed in some academic
institutions.
3.1.7 There is increasing recognition that
drug use and medication management requires not only clinical
research, but also research into social, behavioural, and economic
factors. This would help inform best use of public investment
into purchasing drugs and treatments. Growing collaboration between
the Medical Research Council (MRC) and the Economic and Social
Research Council (ESRC), underpins the importance of joint research.
— Social, behavioural, and economic
research should be initiated and encouraged in order to inform
on patterns of drug taking.
3.1.8 There is a need to invest in this
"insight" research in order to (a) appreciate the reasons
why consumers use OTC and prescribed medications; (b) consider
how to improve prescribing practices (eg avoiding wasteful prescribing);
(c) understand the power and influence of the different players
in medication management at all levels (consumers, professions,
regulators, industry, government).
4. PROVISION
OF MEDICINES
INFORMATION AND
THEIR PROMOTION
4.1 Commissioners recognise the diversity
of sources from which information on medicines is now generated
and received by the public; these include school curricula, electronic,
broadcast, and written media, industry sponsored information,
specialist user groups, and medical evidence websites. We note
that any developments must take account of the full range of resources,
and that the government has particular responsibility for ensuring
that the public is given best advice on how to read and interpret
such findings.
4.2 There are many ways in which drug information
is provided. For statutory reasons, the Patient Information Leaflets
(PILs) are provided with all medications dispensed to the public.
However, these leaflets are often difficult to understand and
excessively detailed. Information is also provided on the packages
in which drugs are marketed, but this means of purveying information
is not always used to best advantage.
— PILs should be made easier to understand,
and regulations changed to enable this when necessary.
— Consideration should be given to
the design and packaging of drugs.
— Patient information should be provided
in a variety of ways.
— Controlled information should be
made available on the internet, websites, and TV resources. These
could be used to back up paper information.
— NHS Direct and other help lines should
be used more for those not keen/able to use IT.
4.3 Pharmaceutical companies promote their
products in many ways. They distribute drug information leaflets
through the post and at meetings. These meetings are either sponsored
(hospitality for scientific meetings) or promotional, and information
is often given about a drug that the company produces. Conferences
and workshops may be sponsored, and doctors can have their expenses
paid for attending meetings at home and abroad. Even if there
is no active publicity, there is a hidden incentive for health
care workers who benefit from such meetings to prescribe the company's
products.
— There needs to be a more open and
transparent approach to the marketing of drugs.
— Health care workers need to be educated
on effective methods of evaluating information that a company
provides.
— In respect of hospitality/sponsorship
activities, pharmaceutical companies and health care professionals
should work in partnership, to ensure that their members comply
with current good practices.
4.3.1 There is a fine line to be drawn between
education and advertising when a drug is being marketed. Basic
scientific information on the development and production of drugs
can be very educational. However, if this is related to the drug
being promoted, it can act as an advertisement.
4.3.2 There is evidence that the distribution
of gifts and grants to individuals for travel to attend conferences
has an influence on their prescribing habits. There is a need
to follow guidelines of good practice and to be open to scrutiny,
audit, and transparency. There are several codes of practice (such
as those formulated by the ABPI and the Royal College of Physicians)
for healthcare workers and companies, which need to be followed.
There is a need for greater transparency.
— Codes of Good Practice should be
followed. Attempts to influence prescribing habits, for example
by advertising, should be minimised, unless there is a good evidence
base for the preference of a particular drug.
5. PROFESSIONAL
AND PATIENT
INFORMATION
Multiple players are involved in the delivery
of drug information to patients. With the extension of public
choice in drug use (increased numbers of OTC formulations) and
a greater range of direct professional involvement in day to day
drug delivery, it is increasingly important that the public and
professionals understand the role of industry in the development
and marketing of drugs and the delivery of information. The Committee
inquiry offers a timely opportunity to review how this may best
be achieved.
5.2 The MHRA (or an equivalent independent
body), needs to have responsibility for the strategic overview
of medicines information. Policies should be developed with the
active involvement of the public, in consultation with voluntary
agencies such as the Long Term Medical Condition Alliance and
other Consumer and Carer groups. The Department for Education
and Skills (DFES) could be included, to ensure the engagement
of school education as well as direct health consumers. Outcomes
might include requirements for examining medicines use under the
citizenship parts of secondary school curricula, to requiring
pharmaceutical studies to be available for external scrutiny by
consumers.
5.3 Professional education is currently
divided across diverse structures, such as: medicines advisory
bodies (eg NICE); regulatory agencies (the MHRA, including the
CSM); companies (subsidy or payment for postgraduate short courses);
the DH (including the Chief Nursing Officer for nurse prescribing);
Professional Bodies (the GMC, the Royal Medical Colleges, the
Royal Pharmaceutical Society, the Nursing and Midwifery Council);
funding bodies (Workforce Confederations/SHAs), and last, but
not least, Higher Education Institutions.
5.3.1 Specific information is given in the
British National Formulary (BNF), which gives detailed information
on drugs prescribable on the NHS, the Drug and Therapeutics Bulletin
(DTB) published monthly, learned journals, and textbooks. These
all provide alternative sources of information. Overall, this
leads to a fragmented, ad hoc system, which does not best oversee
and provide for the needs of consumers. It is recognised that
there is a significant number of errors in prescribing, which
range from wrong dosages to prescribing the wrong drugs.
5.3.2 It is critical that the above range
of professional bodies should provide credible information. However,
currently, because of their diversity, there is a lack of coherence
of approach.
— In order to rationalise the prescription,
supply, and administration of pharmaceutical products, a Council
should be established to be responsible for the strategic development
of a comprehensive, future-looking plan for undergraduate and
postgraduate education development across the full range of health
professionals.
— Better education in prescribing and
adverse drug reactions and interactions should be provided throughout
the careers of prescribers.
— Any education should include the
understanding of the role of the pharmaceutical companies and
an awareness of the potential impact of their activities on prescribing
and research practice.
— Companies should be encouraged to
develop ways of educating health professionals and the public
(eg through informative websites). The nature of the information
purveyed in this way needs to be scrutinized for bias.
5.4 The pharmaceutical industry provides
substantial input to the education and training of pharmacologists
and toxicologists in UK universities. This takes the form of providing
guest lecturers, grants to enhance research projects, and providing
training in integrated pharmacology and physiology for undergraduate
and postgraduate students. This is often done in collaboration
with the British Pharmacological Society and the Physiology Society.
In a recent survey the decline in teaching of
integrative pharmacology/physiology in UK universities was highlighted
suggesting that collaboration between industry and learned societies
should be encouraged and supported by funding agencies. It is
encouraging to note that a small number of MRC PhD studentships
for whole animal pharmacology, physiology, and toxicology have
already been ring-fenced to start in 2005.
5.5 Drug treatments can be very complex
and there are few black and white issues. The needs of very ill
people to get better treatments have to be constantly balanced
against assessments of probable levels of risk. Over time, the
UK will probably move to a culture in which people make more informed
choices about the balance of benefits and harms of treatments.
In this environment people will have a more healthy scepticism
and more realistic expectations about any medical intervention.
Public education on assessing the balance of benefits and harms
is necessary.
6. REGULATORY
REVIEW OF
THE QUALITY,
EFFICACY, AND
SAFETY OF
MEDICINES
6.1 Drug regulation in the United Kingdom
has developed a system that is often used as a model for other
countries. This is largely due to the control that is provided
by the Medicines and Healthcare products Regulatory Agency (MHRA).
Commissioners welcomed the 2003 Audit Commission report on the
work of the Medicines Control Agency, the predecessor of the MHRA,
reporting on its strengths but also proposing changes that included
better communication and public participation in decision-making.
6.2 However there are two potential areas
of conflict of interest within the MHRA that should be considered.
First, funding for the activities of the MHRA comes from the pharmaceutical
industry itself, from fees for licensing. Secondly, the MHRA acts
as the regulatory body for both the licensing of new medicines
and the pharmacovigilance of new and established medicines, through
a complexity of divisions and committees.
— There should be a transparent division
between the two main functions of the MHRA (licensing and pharmacovigilance).
— Serious consideration should be given
to providing government funding for the MHRA.
6.2.2 Checks and balances need to be made
more explicit, more diverse, and more imaginative, in order to
meet changing social expectations for influence, transparency,
and accountability. The MHRA has a major role to play in communicating
these changing requirements to a public that increasingly welcomes
such information.
6.2.3 Pharmaceutical companies have both
a legal and a moral obligation to report to the Regulatory Agencies
any patient reports of adverse events that they receive. Companies
also follow these up (with patient consent) with the patient's
General Practitioner, but the response rate by GPs to these follow-ups
is extremely low.
— Doctors should be encouraged to take
part in pharmaceutical company initiated reporting of adverse
drug reactions and to report them themselves. Financial incentives
should be considered.
6.2.4 The range of media from which public
and professional information is collected should be recognised
and use should be made of modern technologies for rapid response.
6.2.5 Serious consideration should be given
to scrutiny by a range of interested parties, including the public,
who pay for medicines directly, over the counter, and indirectly,
through taxes, and those who prescribe, supply, and administer
the products. This also relates to the point about active diversity
in professional and public education.
6.2.6 A key target would be to shorten the
delays in getting from early reports of problems to regulatory
action. Patient organisations could play a valuable role, by picking
up early signals and by working with regulators to conduct quick
initial surveys to see if a full investigation is merited.
7. PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
7.1 There are many other sources of influence
that interact in complex ways with the pharmaceutical industry;
these should be made more transparent. Once a drug is licensed
and available for prescription in the NHS, the price may be influenced
by NICE decisions, decisions of drug and therapeutics committees
(which influence local negotiations between Trusts' purchasing
departments and companies), possibilities of therapeutic substitutions
(some of which may be limited by the need to conform with the
Medicines Act), and possibilities for the importation of parallel
drugs (although the use of such products is often offset in the
UK by unintelligible patient information in different languages).
7.2 There would be potential savings to
the NHS if there were central negotiations on behalf of Trusts/
PCT consortia.
The mechanisms that companies use to profit
from their products should be explicitly acknowledged and analysed,
to explain why the same product can cost markedly different amounts
in different parts of Europe and in different parts of the NHS.
8. SUMMARY
The following are the main suggestions and recommendations
of the Medicines Commission following its discussion on the
"Influence of the Pharmaceutical Industry":
— Creation of a reliable kite mark
for evidence-based information on drugs and drug products.
— An umbrella body to promote good
practices in prescribing, supply, and administration of medicines.
— Development of methods to encourage
the production of innovative drugs.
— Development of basic scientific research
institutes in the UK, perhaps jointly funded by Universities and
companies.
— Companies should be encouraged to
fund early research into the adverse effects of their drugs and
ways of predicting or avoiding them.
— All medical research in pharmaceutical
companies should follow the principles of research governance.
There should be consistent standards of quality, appropriate methods,
ethical review, and outside scrutiny.
— There should be a requirement to
publish all data, backed up by the compulsory trials register.
— There should be careful scrutiny
of the medical conditions for which drugs are promoted.
— Social, behavioural, and economic
research should be initiated and encouraged in order to inform
on patterns of drug taking.
— PILs should be made easier to understand,
and regulations changed to enable this when necessary.
— Consideration should be given to
the design and packaging of drugs.
— Patient information should be provided
using a variety of ways.
— Controlled information should be
made available on the internet, websites, and TV resources. These
could be used to back up paper information.
— NHS Direct and other help facilities
should be used more for those not keen/able to use IT.
— There needs to be a more open and
transparent approach to the marketing of drugs.
— Health care workers need to be educated
on methods of adequately evaluating information that a company
provides.
— In respect of hospitality/sponsorship
activities, pharmaceutical companies and health care professionals
should work in partnership, to ensure that their members comply
with current good practices. Codes of Good Practice should be
followed. Attempts to influence prescribing habits, for example
by advertising, should be minimised, unless there is a good evidence
base for the preference of a particular drug.
— In order to rationalise the prescription,
supply, and administration of pharmaceutical products, a Council
should be established to be responsible for the strategic development
of a comprehensive, future-looking plan for undergraduate and
postgraduate education development across the full range of health
professionals.
— Better education in prescribing and
adverse drug reactions and interactions should be provided throughout
the careers of prescribers.
— Any education should include the
understanding of the role of the pharmaceutical companies and
an awareness of the potential impact of their activities on prescribing
and research practice.
— Companies should be encouraged to
develop ways of educating health professionals and the public
(eg through informative websites). The nature of the information
purveyed in this way needs to be scrutinized for bias.
— There should be a transparent division
between the two main functions of the MHRA (licensing and pharmacovigilance).
— Serious consideration should be given
to providing government funding for the MHRA.
— Doctors should be encouraged to take
part in pharmaceutical company initiated reporting of adverse
drug reactions and to report them themselves. Financial incentives
should be considered.
9. REFERENCES 1. US
Food and Drug Administration. Challenge and opportunity on
the critical path to new medical products. 2004. (http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html).
2. Jewkes J, Sawers D, Stillerman R. The
Sources of Invention. 2nd edition. WW Norton, 1968.
3. Goozner M. The $800 Million Pill.
University of California Press, 2004.
4. Greenhalgh T, Kostopoulou O, Harries
C. Making decisions about benefits and harms of medicines.
BMJ 2004; 329: 47-50.
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