Memorandum by the Consumers' Association
(PI 53)
1. SUMMARY
1.1 Consumers' Association (CA) welcomes
this Inquiry into the influence of the pharmaceutical industry
(Industry). This investigation provides a timely opportunity to
scrutinise how Industry affects Government, regulators, healthcare
professionals and consumers and to assess the effects of this
influence on public health. We are concerned that a weak and uncoordinated
regulatory system is enabling the Industry to further its own
interests without sufficient regard to public health.
1.2 Specifically, CA has identified serious
shortcomings in the way that drug promotion is handled by the
numerous bodies involved with regulation in this area and in relation
to the process for reclassification of medicines. Misleading advertisements
to healthcare professionals and more covert promotional campaigns
aimed at the public can run unchecked—and proliferate—due
to inadequate procedures for monitoring and enforcement. This
leads to significant decisions being taken in relation to individual
healthcare and prescribing which may impact negatively on both
an individual level and on the wider NHS, for example, in relation
to unnecessary expenditure or inappropriate treatment.
1.3 Equally, we have serious concerns about
the process for selecting and approving medicines for reclassification.
The process is driven by inappropriate targets and without due
consideration to public health need or a satisfactory level of
safety and efficacy data. This exposes the public to potentially
serious adverse reactions or, at the very least, to spending money
on treatments that are ineffective.
1.4 Fundamentally, medicines policy is not
well-coordinated between agencies and the medicines regulatory
system is characterised by a lack of clarity, transparency and
openness, minimal consumer representation and an approach more
geared to the needs of industry than to public health protection.
1.5 We believe that the following actions
are essential to ensure that public health is the paramount objective
of pharmaceutical policy:
— The Medicines and Healthcare products
Regulatory Agency (MHRA) needs to ensure that all its work is
undertaken in the interests of public health protection. This
would be facilitated by appropriate involvement of lay representatives
and representatives of all key stakeholders, in particular, patients
and the wider public. The medicines regulatory system as a whole
also needs to be subject to far greater transparency and clarity
and communication over roles, remits and responsibilities to ensure
accountability and swift and effective action where necessary.
Other regulatory bodies, such as the Food Standards Agency, hold
Board Meetings in public and make minutes of meetings available
on their website. These practices should be adopted by the MHRA.
An independent review of the medicines regulatory system would
be timely. The Government needs to take action to ensure an integrated
medicines policy.
— Responsibility for monitoring all
forms of pharmaceutical industry advertising and other promotion
should be transferred to a new, independent advertising and information
regulator. This regulator should adopt and proactively implement
robust and transparent procedures to prevent misleading promotional
campaigns—including all forms of covert promotion—as
far as possible at the outset, and to take swift and effective
action when these do occur. These procedures should be drawn up
in consultation with all relevant parties, in particular, those
representing the interests of patients, consumers and public health.
Most importantly, they should maintain a clear focus on protecting
public health and delivering public benefit.
— The Government should remove its
targets for the annual number of drug reclassifications and instead
charge the MHRA with approving reclassifications only where they
are demonstrably in the public interest. Decisions must be based
on adequate safety and efficacy data and no medicines should be
reclassified where there is doubt over safety or efficacy in the
target population at the dose specified. Reclassifications should
be supported by a single pharmacy protocol and should be subject
to full monitoring to ensure that the expected benefits are being
delivered.
2. INTRODUCTION
2.1 CA is an independent, not-for-profit
consumer organisation with around 700,000 members. Based in the
UK, it is the largest consumer organisation in Europe. Entirely
independent of government and industry, we actively campaign on
behalf of consumers and are funded through the sale of our Which?
range of consumer magazines and books. We campaign on a wide range
of issues relevant to consumers, of which a key example is health.
Our health campaign aims to ensure all consumers have access to
safe, high-quality and patient-focused healthcare whenever and
wherever they need it, and they have the necessary information
and support to be able to make informed decisions about their
healthcare. This aim is supported through consumer and health
policy research, Which? magazine reports and Treatment Notes—a
bulletin written in conjunction with Drug and Therapeutics
Bulletin (DTB)—which provides patients with independent
medicines and treatment information.
2.2 CA has had a long-standing interest
in medicines policy. DTB plays an important role in helping
prescribers by providing information about the effectiveness and
safety of treatments. As part of its role in informing healthcare
professionals, DTB has discovered and highlighted instances
where promotional material to healthcare professionals is misleading
or inaccurate and has also identified concerns with the level
and type of information provided through authorised documents,
such as the Summary of Product Characteristics.
2.3 CA also deals with broader policy issues
about medicines from a public perspective. We have a particular
interest in user involvement at all levels of decision-making,
from decisions about individual treatment through to involvement
in wider policy decisions about which specific treatments are
provided on the NHS and why. CA has researched and published reports
on the patient information leaflets that are included with all
prescription drugs, on the promotion of prescription drugs directly
to patients, on the outcome of a CA inquiry into how well NICE
works from the patient perspective and on the provision of patient
information.
2.4 In the first half of 2004, we conducted
research with consumers on their perceptions and attitudes to
medicines' use, and also with general practitioners on their attitudes
to promotional material and contact from pharmaceutical companies.
This memorandum highlights some of this research, as well as drawing
on our earlier relevant research. Additionally, we are continuing
to conduct research in this area and will keep the Committee updated
on any relevant future work.
2.5 Our research and campaigning activities
have centred predominantly on the following three areas, which
will provide the focus for our submission:
— the provision of drug information
and promotion;
— professional and patient education;
— regulatory review of drug safety
and efficacy.
3. THE REGULATORY
CONTEXT
3.1 Protecting the public and consumer interest
must be at the heart of any regulator's powers, decision-making
and actions. While the MHRA (formerly the Medicines Control Agency;
MCA), in common with most regulators, has a public interest/consumer
protection objective, this is challenged by objectives relating
to protection of the interests of the pharmaceutical industry.
3.2 The MHRA has a dual role: protection
of public health and the service it must deliver to industry,
for example, in relation to licensing. This was highlighted by
the National Audit Office (NAO) in its report on the MCA in January
2003.[2]
The original requirement to avoid creating "unnecessary impediments"
to the pharmaceutical industry became "to facilitate the
development of a successful UK pharmaceutical industry for the
benefit of the wider interest of the UK economy" in the Agency's
2001 Corporate Plan. This was reflected in its close involvement
with the Pharmaceutical Industry Competitiveness Task Force (PICTF)
set up by the Government in March 2000. In the 2004 Corporate
Plan, this wording refers to supporting innovation "without
unnecessary regulatory impediments", but the challenges of
the dual role remain.
3.3 The MHRA must meet clear expectations
of Industry to provide an efficient service in return for fees.
This is supported by performance targets based on factors such
as the speed with which new drugs are assessed. While, in theory,
such targets may bring benefits for patients, this is clearly
not the case if they are pursued at the expense of a thorough
review and an emphasis on safety and public health protection.
The pressure on the MHRA to compete in a European regulatory environment
is likely to exacerbate this situation. The NAO report states:
"Most regulators focus on measuring the efficiency of their
operations by reference to the speed with which they assess new
drugs . . ". In the European Union, where companies can choose
where to place their business based on speed and quality of service
of the regulator, success in competition for regulatory work can
also be used as a performance measure".[3]
3.4 The relationship that Industry has with
Government is also significant. The MHRA's Corporate Plan 2004
refers to the "important role to play in ensuring that key
ministerial objectives for the health service are achieved, including
the wider availability of medicines".[4]
This complements the vision within the Wanless Report (2002)[5]
of a future in which "people increasingly take responsibility
for their own health and well-being". However, while ensuring
the wider availability of medicines in this way may benefit the
public, it is not necessarily the case. For example, where there
are concerns over the safety or efficacy of the medicines being
reclassified, where the medicines being selected for reclassification
are not those that would most benefit public health needs and/or
where the support and monitoring systems are insufficient.
3.5 There is a need for meaningful public
scrutiny and input into the setting of the key parameters for
the MHRA. Regulatory decisions should take the protection of the
consumer as a starting point and be based on cost-benefit analyses
which address potential consumer detriment.
FUNDING
3.6 The MHRA is one of only two European
medicine regulators fully funded by Industry. CA's experience
with regulators across a range of sectors indicates that the way
a regulator is funded does appear to influence the way it operates.
Government-funded regulators seem to be better at acting independently
of industry or professional interests and to take a more robust
approach to promoting the public interest or consumers' interests.
Where funding is provided by those who are regulated, there appears
to be greater problems in ensuring the independence of the regulator.
3.7 As the NAO report states, "funding
from the pharmaceutical industry can enhance efficiency but reliance
is a cause for concern for stakeholders".[6]
The MHRA states that funding does not in itself pose a conflict
of interest because there are independent committees to act as
a safeguard. We have concerns about the extent to which these
committees operate transparently and draw on expertise from outside
the Industry. If the MHRA is to operate, and be seen to operate,
in the interests of the public then transparency and accountability
are of the utmost importance.
TRANSPARENCY
3.8 Regulators must command public confidence
by operating in a fair, open and transparent way to benefit all
consumers. Fundamental to this is ensuring that there is access
to information and that most of the information regulators base
their decisions on is in the public domain. Consumers should be
able to find out easily what the body does, readily access its
services and find out what decisions it is taking and how. Currently,
it is extremely difficult to obtain information from the MHRA
and most of its decision-making remains opaque, for example, in
the recent decision to reclassify the prescription-only medicine,
simvastatin, as an over-the-counter (OTC) product, Zocor Heart-Pro.
The NAO report referred to consultations with patient groups and
other stakeholders, concluding that "there was scope to improve
the transparency of these consultations"[7].
3.9 Greater openness and transparency would
be facilitated by:
— Board meetings and key committee
meetings held in public (as with the Food Standards Agency).
— Board meetings publicly advertised
in advance.
— Publication of Board papers and decisions.
— A requirement to provide all information
requested by consumer groups and other parties unless it is genuinely
commercially sensitive or personally confidential information.
— Effectiveness on openness and transparency
to be regularly assessed and reported on in the Annual Report.
3.10 Access to information concerning any
of the regulator's decisions or policies is vital to ensure openness,
transparency and accountability. While CA recognises the legal
requirement to protect genuinely sensitive market information,
we are concerned that the MHRA adopts a very restrictive approach
to sharing information.
ACCOUNTABILITY THROUGH
CONSUMER REPRESENTATION
AND INVOLVEMENT
3.11 Parliamentary scrutiny is necessary,
but not sufficient, to ensuring regulators are publicly accountable.
Consumer representation and involvement is part of that process,
as is greater engagement with stakeholders through meetings and
wider publicity of the role and purpose of regulators. The MHRA
has an advisory structure of independent committees. However,
these committees are fairly "closed" with very little
consumer representation in decision-making. The MHRA Business
Plan (2004) refers to the "facilitation and encouragement
of lay and patient representation on these bodies wherever it
is appropriate" but it is unclear what constitutes "appropriate".
Where lay representatives are currently involved, they are in
the minority. CA believes that regulators must seek out and incorporate
consumer views at all stages of their work, including development
of policy, and that a variety of methods for actively consulting
with the general public should be adopted, with views being incorporated
into decision-making. While the creation of special interest committees
which incorporate consumer representation is a step in the right
direction, there nevertheless needs to be independent consumer
representation in every aspect of the regulator's remit.
3.12 More robust promotion of the consumer
interest may be aided by a separate body or structure within the
regulatory framework that has a clear mandate to promote and protect
consumer interests. In order to be truly independent and have
sufficient authority, any consumer panel or committee must have:
— The ability to definite its own remit,
set its own agenda, decide on its own priorities and which issues
to investigate, and appoint its own chair.
— Its own separate funding, which provides
adequate resources for the job, including to commission its own
research.
— Rights to access any necessary information.
3.13 There is a clear need for an independent
review of the MHRA, going beyond the scope of the NAO report.
In particular, this review should consider:
— the extent to which the regulator's
public interest objective is undermined by its relationship with
Industry;
— ways in which the regulator's workings
could be made more transparent and accountable; and
— means of ensuring effective consumer
representation and involvement.
4. The provision of drug information and promotion
4.1 The public and healthcare professionals
need high-quality drug information, and the pharmaceutical industry
has a legitimate interest in promoting its products. Both information
and promotion need to be delivered in a transparent framework
which safeguards the public interest and has clear, meaningful
sanctions if this interest is undermined. At present, this is
not the case. Our research has uncovered substantial use of covert
promotional techniques to the public and illegal advertising to
healthcare professionals.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION TO
THE PUBLIC
4.2 While there is a great deal of health
information available to the general public, much of this is misleading,
inaccurate or simply does not meet individual needs. Where high-quality,
independent information does exist, it is difficult for consumers
to know where to look for it and whether they can trust it. In
our policy report "Patient Information: What's the Prognosis"
(2003), CA called for an overhaul of patient information. This
included the establishment of an independent body to oversee the
development and implementation of an effective patient information
strategy that would meet the information needs of patients and
carers for independent, accessible and objective information.
Through this work, which involved consultation with patient and
carer organisations, we identified ten core principles that we
maintain should underpin high-quality standards for information.
Information that conforms to these standards would be: accessible,
accurate, appropriate, consistent, current, evidence-based, non-biased,
timely, transparent and understandable.
4.3 The pharmaceutical industry cannot,
by definition, produce this kind of information. However, it does
seek a role in providing patient information and education. In
particular it has lobbied, to date unsuccessfully, for a relaxation
of the laws prohibiting direct-to-consumer advertising (DTCA)
of promotion drugs with the intention of "improving"
patient information. In the United States of America and New Zealand,
where DTCA is currently permitted, it has led to dramatic increases
in the drugs bill; increased unnecessary use of medicines; distorted
prescribing behaviour; and exposed the public to numerous misleading
and inaccurate advertisements through the popular media.
4.4 CA is continuing to research this area
to further evaluate how the patient information environment is
developing and will keep the Committee informed of its work.
PATIENT INFORMATION
LEAFLETS (PILS)
4.5 PILs are required by law to accompany
all medicines and are the key piece of information that drug companies
are legally required to provide patients. They are also likely
to be the only information that an individual will have when collecting
a prescription or buying an over-the-counter medicine. They contain
essential information about how to take the medicine and about
potential interactions with other medicines and side effects and
what to do if these occur. The PIL must be produced in line with
the Summary of Product Characteristics (SPC) which is provided
to healthcare professionals and is authorised by the regulatory
authority as part of the drug licensing process.
4.6 CA focus group research with patients,
published in June 2000,[8]
found that patient information leaflets failed to give patients
the information they need in a way that is easy to understand.
Small print and too much information, combined with poor layout
and overuse of medical jargon were the key problems. This was
despite a legal requirement that leaflets "should provide
a high degree of consumer protection, in order that medicinal
products may be used correctly on the basis of full and comprehensive
information" and "must be written in clear and understandable
terms". These concerns were echoed in the NAO report on the
MCA. The Association of the British Pharmaceutical Industry (ABPI)
has argued that legislation which determines the content of the
patient information leaflet prevents it from addressing such inadequacies.
However, this is not the case. Companies can improve patient information
leaflets to make information clearer and more meaningful to users
within the legal framework.
4.7 CA has long argued for user-testing
to ensure that patients can read and understand PILs and this
has now been incorporated into European legislation. However,
it is essential that this is carried out in a meaningful way,
for example, according to the Australian "gold standard"
approach, whereby 20 potential users of a medicine who are given
a PIL are asked to find and explain 15 pieces of information.
The "gold standard" is a leaflet where 16 out of 20
people can find and explain all the points. Only PILs that reach
the gold standard are permitted.[9]
4.8 CA would also like the "black triangle"
(a symbol used to denote a drug that is being closely monitored)
used on the PIL to help alert patients to the fact that the drug
is under intensive surveillance for adverse effects and to increase
pharmacovigilance data for these products. The significance of
the black triangle will first need to be explained to patients.
4.9 The MHRA has a duty to ensure that PILs
are developed that give people important information about medicines
in a way that they can understand and should not permit any PILs
to be approved that do not comply with this requirement. This
should form a key objective on which the performance of the MHRA
is assessed.
DIRECT-TO-CONSUMER
ADVERTISING (DTCA) OF
PRESCRIPTION-ONLY
MEDICINES
4.10 DTCA is when drug companies advertise
prescription-only medicines (POMs) directly to the public. Currently,
DTCA is permitted in only two developed countries: the United
States of America and New Zealand. The negative impact of DTCA
has been well-documented[10]
and includes:
— generating "lifestyle"
conditions (eg female sexual dysfunction)[11]
which could lead to an unnecessary use of medicines;
— a dramatically increased drugs bill.
For example, in the USA, prescription drug sales increased by
$20.8 billion between 1999 and 2000. The 50 medicines with the
highest advertising budgets accounted for nearly half of the increase,
with the top-selling drugs being those that were most heavily
DTC-advertised.[12]
A DTCA campaign by Novartis in New Zealand for an oral systemic
anti fungal called "Lamisil" (for the treatment of fungal
nail infections) saw an immediate month on month doubling of prescriptions
for this drug;[13]
— distorted prescribing behaviour in
response to increased public demand for POMs;[14]
and
— a down-playing of side-effects.[15]
4.11 There are now calls to introduce a
ban on DTCA in New Zealand as a result of its negative impact
on public health.
4.12 Proposals by the European Commission
that would have allowed the introduction of DTCA into Europe were
defeated in EU Parliament in December 2003. As a result, there
is pressure upon the pharmaceutical industry to be more creative
in its promotional methods to healthcare professionals, prescribers
and the public.
COVERT PROMOTION
TO THE
PUBLIC—DISEASE
AWARENESS CAMPAIGNS
4.13 CA highlighted a range of methods employed
by the pharmaceutical industry to promote prescription drugs which
manage to circumvent DTCA in our report "Promotion of Prescription
Drugs: Public Health or Private Profit?" published in July
2001. One such method increasingly used is the so-called "disease
awareness campaign". This apparently sets out to raise awareness
about a particular condition or disease, such as obesity, erectile
dysfunction or toenail fungal infection. It also carries the sponsoring
companies' logo, often an endorsement from an appropriate voluntary
organisation, may be fronted by a celebrity and may coincide with
a marketing campaign targeted at healthcare professionals for
a specific branded product.
4.14 Further information is usually offered,
either by way of a telephone helpline or a reply form to post.
Respondents' contact details are then held by the pharmaceutical
company sponsoring the campaign. For example, Pharmacia ran an
incontinence disease awareness campaign in the autumn of 2003.
Using the same imagery for both public and healthcare professional
promotion they named their campaign "The Public Health Education
Campaign". The voice of Anna Raeburn (a famous agony aunt)
was heard on the helpline and, having registered one's details,
a letter would follow from `The Public Health Education Campaign'
announcing to the recipient that it was "Time to take charge".
4.15 These campaigns are promotional and
exist to increase demand for companies' products. This may be
clearer in some cases than others. One example clearly directing
people to their GP is Novartis' longstanding Stepwise campaign
on feet and nails. This features a booklet "Feet & Nails—stamping
out fungal nail infection and athlete's foot" which was produced
in association with The Society of Chiropodists and Podiatrists
promotes Lamisil (terbinafine). Page 6 states: "Although
you may find a limited selection available over-the-counter at
your local pharmacy, the most effective ones are only available
from your doctor . . .".[16]
4.16 As with DTCA, disease awareness campaigns
tend to focus on what has been termed "lifestyle" conditions
and offer drug solutions, albeit more covertly and therefore potentially
more dangerously.
4.17 Further examples of covert Industry
promotions can be through media editorials. The MHRA confirmed
to CA[17]
that while it considers each advertising complaint in relation
to reporting individually, it adopts the view that print content
is deemed promotional only by intention. The letter from the MHRA
states: ". . . where promotion does occur but it is incidental
and subordinate to another purpose such as providing the reader
with information then the material is not `designed to promote'
and is therefore not caught by the Regulations . . . the fact
that a positive review of a medicine may encourage readers to
seek it out is incidental in our view and does not equate to a
finding that the article was written for that purpose . . . balanced
information from a patient organisation including the range of
medicines available would be considered differently from the situation
where a pharmaceutical company provides some of the same information
but including only the one product it markets."
4.18 Advertising is not the same as comprehensive,
unbiased information. The media is a popular way of planting advertorials
placed by, or on behalf of, Industry through articles that are
not based on legitimate assessments of drugs. It is important
that the MHRA encourages all health writers and editors to promote
and undertake responsible reporting, and for them to be held accountable
where there are such breaches of the Advertising Regulations.
PATIENT GROUP/CHARITY-FRONTED
CAMPAIGNS
4.19 As the public tends to distrust information
provided directly by Industry,[18]
using patient organisations to front campaigns can effectively
mask drug companies' involvement and enable them to engage with
an audience they may not otherwise have access to.
4.20 The potential benefits to Industry
of collaboration with patient groups are immense.
4.21 While some (typically larger) charities
have a clear and accessible policy on their links with Industry,
in general, there is a distinct lack of transparency about such
relationships.[19]
4.22 In 2002, GlaxoSmithKline (GSK) produced,
and funded, a Mr Sneeze booklet on allergies (working with the
charity, Allergy UK). This targeted children, effectively promoting
two of its over-the-counter (OTC) products, Piriton and Piriteze:
the last few pages of this document were specifically about the
products. Although promotion of OTC products to children is illegal,
the Proprietary Association of Great Britain (PAGB) nevertheless
approved the Mr Sneeze book. In October 2003, the MHRA upheld
a complaint about this underhand tactic of using children for
promotional purposes. As a result, GSK was required to separate
the promotional pages from the rest of the booklet.[20]
However, the MHRA's action came too late and did not go far enough.
It did not prevent the information from finding its target audience,
so allowing children to be used as a means to promote GSK products.
4.23 The first Allergy UK, knew of any controversy
regarding the illegal promotion within the book was when it was
approached by the media. This caused embarrassment by drawing
unwanted attention to the charity.[21]
4.24 Drug companies have also been known
to use public relations companies to assist with promotional activity.
For example, The Observer newspaper[22]
discovered that Burson-Marsteller, a public relations firm, managed
to persuade various celebrities to support a "sophisticated
lobbying campaign" masked as a crusade to introduce a new
NHS screening test that could supposedly save the lives of thousands
of women. However, celebrities contacted by The Observer said
they had no knowledge of the lobby group.
4.25 Other creative techniques have involved
using general practitioners as the go-between in eliciting feedback
from patients. In the case of Cipralex, an antidepressant, general
practitioners were provided with feedback pamphlets and asked
to complete "think bubbles"—one outlining the
patient experience; the other the general practitioner experience.
As a reward for doing so, the drug company pledges a £1 donation
to the charity, Depression Alliance.
4.26 Charities, particularly smaller ones
that are less well funded, need to be protected from exploitation
while at the same time accepting their duty to behave fairly and
responsibly. Patient organisations should have accessible, clear
and transparent policies for collaborating with corporate sponsors.
We understand the Long-term Medical Conditions Alliance is intending
to revise its own guidelines.
4.27 Existing disease awareness guidelines
are insufficient to address the impact and extent of the covert
promotion. Our research with GPs in May 2004[23]
shows that they are concerned about disease awareness campaigns
and other covert promotions, but are resigned to them being funded
by industry in the absence of alternative funding.
4.28 The GPs expressed irritation at having
to rectify misconceptions fostered by inappropriate (lifestyle)
disease awareness campaigns. They also reported that they will
sometimes prescribe according to patient demand, even when they
may not consider such a prescription to be the most appropriate.
Doctors referred to it being too complicated to explain the "ins
and outs" of other, potentially more appropriate and possibly
cheaper medicines. In theory the GPs objected to prescribing upon
request, but in reality they admitted to doing so.[24]
This finding has also been reported in the USA.[25]
4.29 In short, the influence of the Industry,
channelled through individual patients, can mean that patients
are prescribed drugs that are inappropriate for them and which
may not be the most cost-effective. This pressure towards inappropriate
prescribing is complemented by the simultaneous pressure of advertising
and promotional activity targeted directly at healthcare professionals.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION TO
HEALTHCARE PROFESSIONALS
4.30 The pharmaceutical industry has considerable
influence over the information received by healthcare professionals.
Drug companies are allowed to advertise directly to such individuals.
However, illegal promotional activity often goes unnoticed or
unpunished so providing no real disincentive against repetition.
SUMMARY OF
PRODUCT CHARACTERISTICS
(SPC)
4.31 The Summary of Product Characteristics
(SPC) for a medicine is written by the holder of the marketing
authorisation for that product (typically the drug manufacturer)
to provide crucial prescribing information for medicine and complements
information contained in the patient information leaflet (PIL).
It is essential that the SPC is full and complete and is able
to aid the prescriber in anticipating and minimising the risk
of preventable side-effects. However, research published by DTB
demonstrates how drug companies often fail in this regard.[26]
DRUG COMPANY
REPRESENTATIVES
4.32 Drug company representatives play an
essential role in influencing prescribing behaviour. CA's research
with GPs (May 2004)[27]
revealed that many doctors tend to enter into a symbiotic relationship
with pharmaceutical companies. The doctors are aware that pharmaceutical
companies do not act altruistically but do offer them a number
of perceived benefits. For example, in spite of acknowledging
the marketing elements to their relationships, they derive what
they consider to be "educational benefits" from being
informed of a particular treatment. Furthermore, it is easy to
maintain relationships with representatives as it requires little
proactivity from the GP.
4.33 Our research highlights the value some
GPs place on their relationships with drug representatives, particularly
as a source of education and information. What is in reality promotion
is perceived by many of the GPs we surveyed to be "educational".
This form of misinterpreted "education" may then become
a steady influence on prescribing behaviour. The pharmaceutical
industry can ensure a service is "up to the minute"
by paying GPs £15 for providing feedback on drug representatives
(www.gpreply.net).
4.34 Even a small item, such as a post-it
pad or pen from a company representative that offers a prescribing
suggestion for a given diagnosis, may have a disproportionate
distorting influence on prescribing behaviour while appearing
to be a harmless and inexpensive gift.
4.35 GPs are short of time and may find
it difficult to keep themselves updated.[28]
It is unacceptable that GPs should have to rely on being "educated"
by drug representatives, whose sole purpose is to influence prescribing
behaviour towards their companies' products.
PUBLIC-PRIVATE
PARTNERSHIPS
4.36 Drug representatives are not the only
means of contact that doctors have with Industry. Following the
Pharmaceutical Industry Competitive Task Force (PICTF) report,
there has been an increase in public-private partnerships between
Industry and the NHS, with questionable results for the public.
An editorial in Pulse magazine[29]
(a weekly publication for GPs) refers to an example of the "creeping
involvement in primary care" whereby Pfizer agreed to reimburse
North Staffordshire Health Authority if its drug—atorvastatin—failed
to cut cholesterol levels to target. The commentary reports that
proponents consider joint working as being "open and transparent"
while others recognise it as "another disturbing example
of corporate influence on prescribing". The article concludes
that while it "must be right to test schemes with the potential
to improve prescribing of effective drugs . . . such a significant
shift in the relationship between drug firms and doctors should
not be allowed to happen by stealth. It's time the Government
came clean on how much industry influence it wants. It should
start by providing a solid ethical framework to guide GPs."
ADVERTISING: PRE-VETTING,
MONITORING, COMPLAINTS
AND ENFORCEMENT
4.37 The current regulatory systems for
handling pre-vetting, monitoring and complaints in relation to
advertising and promotion are inadequate and, as such, put public
health at risk. The MHRA has, itself, confirmed that it cannot
vet all promotional material and that the vetting system "in
part relies on concerns being drawn to its attention because of
the volume of advertising material".[30]
4.38 The process of handling complaints
about promotion is complicated by the existence of various bodies
with responsibilities in this area (each with different powers),
for example, the Medicines and Healthcare products Regulatory
Agency (MHRA—which has statutory powers), the Proprietary
Association of Great Britain (PAGB), the Prescription Medicines
Code of Practice Authority (PMCPA), both of which operate Industry
self-regulation, and the Advertising Standards Authority (ASA).
In addition, OFCOM has statutory powers for broadcasting advertising
which will be contracted out to the ASA (late 2004). Crucially,
there appears to be no coherent relationship between these bodies.
For example, the ASA recommends that the MHRA addresses complaints
about prescription-only medicines (POMs). Both the MHRA and the
ASA can address complaints relating to advertisements for over-the-counter
(OTC) medicines. The PMCPA may respond to a received complaint
or investigate independently.
4.39 The PMCPA does not communicate with
the MHRA in any procedural manner. One consequence is that both
the MHRA and the PMCPA may end up investigating the same complaint
and reaching different conclusions.
4.40 This occurred, for example, in the
case of advertising for the oral contraceptive, Yasmin[31]
(see paragraphs 4.45-4.54), whereby the, then, Medicines Controls
Agency (now the MHRA) and the PMCPA initially took different views
about whether the advertisements for Yasmin were in breach of
the Advertising Regulations.
4.41 A subsequent difference of opinion
between the PMCPA and MHRA arose following concerns raised by
DTB about promotional messages on Janssen Cilag's website
for women taking the oral contraceptive, Evra.[32]
The PMCPA found the company to be in breach of the Authority's
Code of Practice on advertising, but the MHRA took the view that
information on the website provided an aid to concordance rather
than promoted the product. The MHRA stated that its judgement
on whether or not the website content was deemed to be promotional
was based on the "overall presentation of the materials".[33]
4.42 The time taken for the MHRA and PMCPA
to process complaints and deliver final rulings is often unacceptably
long.[34]
Both the MHRA and the PMCPA treat the proceedings of any investigation
as confidential until such time that they are published. However,
by the time a complaint has been investigated and a ruling delivered,
the drug company's promotional campaign may well have run its
course. In the case of Yasmin, around six months elapsed between
the time that the advertising was first launched and when it was
"voluntarily" withdrawn, as a result of the MHRA's revised
decision to request this.
4.43 A drug company found to have breached
Advertising Regulations by the MHRA may be required to issue a
corrective statement about any misleading claim. However, delayed
publication of such statements obviously reduces their impact,
particularly if it occurs several months after the start of the
campaign. In the past, DTB has had to urge the MHRA to
ensure statements are issued (eg as with an advertisement for
Yasmin).[35]
Where an advertisement has been found to be in breach of the Advertising
Regulations, it should be mandatory that prominent publication
of a corrective statement is made immediately.
4.44 DTB articles have highlighted
a total of seven examples of misleading or inappropriate promotion
in the last two years. All examples relate to prescription-only
medicines from different companies, perhaps suggesting an Industry-wide
tendency to mislead. In six of these cases, the Prescription Medicines
Code of Practice Authority (PMCPA) responded to the articles by
investigating the relevant promotion and publishing its findings.
4.45 The promotion of the oral contraceptive
pill, Yasmin, provides a clear demonstration of various inadequacies
in the pre-vetting and complaints system.
4.46 Product:
Yasmin; Drug company—Schering Health Care.
Is Yasmin a "truly different" pill?" (DTB
article published August 2002).
Yasmin advert withdrawn—why and
how (DTB article published March 2003).
PMCPA proceedings: initiated 15 August 2002;
case completed 17 December 2002; publication February 2003.
4.47 In April 2002, Schering Health Care
(Schering) launched Yasmin in the UK, claiming, in an advertisement
to healthcare professionals, that the medicine was "the pill
for well-being" and that "Yasmin is different in many
ways. It has been shown repeatedly to have no associated weight
gain. In addition, Yasmin has a demonstrable effect on PM (pre-menstrual)
symptoms and on skin condition . . . Women feel well on Yasmin.
Make a difference to their lives and prescribe Yasmin."
4.48 DTB published a review of Yasmin
in August 2002, which concluded that "we believe that the
claim that Yasmin `is the pill for well-being' is unjustified
and misleading and should be withdrawn." In response, Schering
threatened (on 9 September 2002) to sue DTB for defamation.
4.49 Prompted by DTB's article, the
PMCPA began an investigation into the promotion of Yasmin and
concluded (on 18 September 2002) that Schering had breached the
Authority's Code of Practice on several counts. As a result, the
company withdrew its threat to sue DTB. The PMCPA later
confirmed its initial findings (after rejecting an appeal by Schering),
in concluding (on 22 November 2002) that the company had breached
the PMCPA's Code of Practice on 11 separate counts.
4.50 The Yasmin advertisement had originally
been vetted by the MCA (now the MHRA) in late Spring 2002. The
MCA told Schering (in a letter dated 13 June 2002) that its promotional
claims for Yasmin were acceptable. The findings of DTB
(subsequently echoed in the PMCPA investigation) suggest a serious
failure in the MCA's original vetting of the advertisement.
4.51 Although the PMCPA first ruled against
the Yasmin advertisement in September 2002, the delayed action
by the MCA allowed the company to continue the misleading promotion
unchecked for around two months after DTB first highlighted
the misleading advertisement (and in total, for around six months
from the product's launch).
4.52 It is also clear that the MCA did not
keep in close contact with the PMCPA during their respective investigations
of the Yasmin advertisement. For example, the MCA did not know
that the PMCPA was investigating DTB's concerns until alerted
by DTB itself. Similarly, the MCA did not know that PMCPA's
rulings had been confirmed (following rejection of the appeal
by Schering) in late November.
4.53 As a result of DTB's August 2002 article,
the MCA undertook a second assessment of Schering's claims for
Yasmin. Only on 6 December 2002 were the results of this investigation
released in a letter to DTB. On this second occasion, the
MCA found Schering's promotional claims for Yasmin wanting. As
a result, the Agency asked the company to withdraw the advertising
and to publish a corrective statement in journals that had carried
the original advertisement. This correction appeared in late February
2003 (around 10 months after the launch of Yasmin).
4.54 The MCA's slowness and secrecy in dealing
with this issue were wholly unacceptable, particularly in view
of the likely effects of the misleading advertisement on prescribing
practice.
4.55 Other recent examples of misleading
advertising identified by DTB include the following (paragraphs
4.56-4.62):
4.56 Product: pimecrolimus (Elidel); Drug
company: Novartis
Pimecrolimus cream for atopic dermatitis (DTB
article published May 2003).
PMCPA proceedings: initiated 19 May 2003; case
completed 11 July 2003; publication August 2003.
An advertisement for pimecrolimus cream (a treatment
for atopic dermatitis) depicted a sleeping child, who appeared
to be much younger than two years of age. Since the drug is not
licensed for use in children under two years old, DTB considered
that the picture could mislead prescribers. The PMCPA agreed that
the image and accompanying text gave the impression that the child
was less than two years old and concluded that, in this regard,
the advertisement was misleading and inconsistent with information
in the product's Summary of Product Characteristics. Two breaches
of the Code of Practice were ruled.
4.57 Product: Cerazette; Drug company: Organon
Is Cerazette the minipill of choice? (DTB
article published September 2003).
PMCPA proceedings: initiated 22 September 2003;
case completed 22 December 2003; publication February 2004.
Advertisements for the oral contraceptive pill
Cerazette claimed that it had "the efficacy of a combined
pill with the reassurance of an oestrogen free pill". However,
DTB disputed this on the basis that there were no published
trials directly comparing Cerazette with a combined oral contraceptive.
The PMCPA agreed that the claim was misleading and ruled that
Organon had committed one breach of its Code of Practice.
4.58 Product: memantine (Ebixa); Drug company:
Lundbeck Ltd
Memantine for dementia? (DTB article published
October 2003).
PMCPA proceedings: initiated 19 February 2004;
case completed 1 April 2004; publication May 2004.
DTB could find no robust scientific evidence
to support Lundbeck's claim that with memantine therapy (a treatment
for Alzheimer's disease) "improvements in activities of daily
living help patients to maintain a degree of independence and
easier to care for, potentially avoiding the need for nursing
home care". Acting on DTB's criticisms, the PMCPA
ruled that the company had committed four breaches of the Code
of Practice.
4.59 Product: Evra; Drug company: Janssen-Cilag:
Evra—a patch on oral contraception? (DTB
article published December 2003).
PMCPA proceedings: initiated 22 December 2003;
case completed 7 April 2004; publication May 2004.
DTB found that Janssen-Cilag's website
for women using the Evra patch was carrying the slogan "Evra
The Right Contraceptive Choice", apparently in breach of
Advertising Regulations on promotion of prescription-only medicines.
DTB informed the MHRA about this finding and, as a result,
the company was asked to remove the slogan. DTB also questioned
the claim on the website that Evra was "just as effective
as the contraceptive pill", because it could find no convincing
evidence on whether the patch was any more or less effective than
a combined oral contraceptive pill. As a result of DTB's
exposure of the use of the slogan "Evra the Right Contraceptive
Choice", Janssen-Cilag "voluntarily" admitted this
use to the PMCPA. The PMCPA ruled that the company had breached
the Code of Practice on two counts. The PMCPA also initially concluded
that the claim "just as effective as the contraceptive pill"
was "not factual or presented in a balanced way". However,
the PMCPA later reversed this latter decision following an appeal
by Janssen-Cilag.
4.60 Product: voriconazole (Vfend); Drug
company: Pfizer
Caspofungin and voriconazole for fungal infections
(DTB article published January 2004).
PMCPA proceedings: initiated 17 February 2004;
case completed 13 April 2004; publication May 2004.
Promotional claims for the antifungal medicine
voriconazole included that it "significantly improved survival
in invasive aspergillosis compared with amphotericin B".
However, on reviewing the relevant data, DTB concluded
that "there is no convincing evidence to justify the claim
that voriconazole is superior to amphotericin B at increasing
survival rates in patients with invasive aspergillosis".
Subsequently, the PMCPA reached a similar conclusion in ruling
that Pfizer had committed three breaches of the Code of Practice.
4.61. Product: Symbicort (budesonide plus formoterol);
Drug company: AstraZeneca
Are Seretide and Symbicort useful in COPD? (DTB
article published March 2004).
PMCPA proceedings: initiated 5 March 2004; case
completed 20 April 2004; publication May 2004.
Promotional claims for Symbicort (a medicine
licensed for treating chronic obstructive pulmonary disease) included
benefits in "reducing symptoms" and "improving
quality of life". However, DTB concluded that Symbicort
did not appear to improve symptom scores any more than did formoterol
(one of Symbicort's two component drugs) when taken on its own.
It also concluded that there was conflicting evidence about whether
Symbicort improved quality of life. These findings seemed at odds
with the advertising claims. The PMCPA subsequently agreed with
DTB's view, concluding that AstraZeneca had committed 10
breaches of the Code of Practice.
4.62 Oral moxifloxacin (Avelox) is an antibacterial
medicine marketed by the drug company Bayer plc, with the promotional
claim that if offers "rapid relief from chest infections".
A recent DTB review of oral moxifloxacin (Moxifloxacin—a
new fluoroquinolone antibacterial) has concluded that "In
our view, claims that oral moxifloxacin provides `rapid relief
from chest infections' are unsubstantiated, may mislead prescribers
and should be withdrawn."
4.63 In relation to another promotional
concern, CA complained to the MHRA in November 2003 about invitations
being distributed to the public inviting them to attend Botox
parties. We were informed in that month that an investigation
would be conducted. Having received no further correspondence
thereafter, we again contacted the MHRA and were subsequently
sent a letter in August 2004 that apologised for the fact that
we had not been notified in January 2004 of the outcome of the
investigation and that the advertising had been withdrawn. This
example provides further evidence of the MHRA failing to effectively
monitor and sanction the promotion of prescription-only medicines.
4.64 The advertising complaints system needs
to be harnessed and simplified, with a clearly stated protocol.
MEANINGFUL SANCTIONS
4.65. While the MHRA has strong powers in this
area, even to the point of prosecution, it appears to underuse
these powers, preferring to treat breaches as administrative matters.
4.66 This suggests that the interests of
Industry are put before those of patients and public health, particularly
since issuing of corrective statements is not mandatory for all
breaches, so prescribers may be completely unaware they have been
misled. Publication of complaints on websites is not an adequate
substitute. The current sanctions are no disincentive for drug
companies pushing the legal boundaries.
4.67 The PMCPA's Code of Practice pamphlet[36]
states: "In each case where a breach of the Code is ruled,
the company concerned must give an undertaking that the practice
in question has ceased forthwith and that all possible steps have
been taken to avoid a similar breach in the future. An undertaking
must be accompanied by details of the action taken to implement
the ruling."
4.68 It also states that "Additional
sanctions [are] imposed in serious cases." The failure to
appropriately enforce these sanctions reflects how the PMCPA fails
to take breaches of the advertising Code of Practice by Industry
seriously.[37]
4.69 Furthermore, what should be considered
a minimum standard of conduct has even been commended by the PMCPA.
For example, one reported case in 2004 of a drug company employee
"inadvertently marketing a drug on a local radio station",
was registered as a "voluntary admission" in the PMCPA
Code of Practice Review May 2004. Although the company was found
to be in breach of the Code, the PMCPA panel nevertheless "commended"
it for reporting the breach.[38]
4.70 In another case a "voluntary admission"
to the PMCPA was recorded even though the "admission"
was made only once the matter had already been raised by DTB
(see paragraph 4.59). Furthermore, there was no reference to this
fact in the PMCPA report.
4.71 As CA has found with the PMCPA, it
would appear that the MHRA also takes a lenient view with regard
to breaches of the Advertising Regulations, given its reluctance
to "resort to formal procedures".
4.72 A complete revision of the sanctions
and penalties used for addressing breaches of Advertising Regulations[39]
needs to be undertaken as a key priority.
4.73 Redress should involve contrite corrective
advertising, payment of the regulator's legal costs and other
relevant financial elements, such as a substantial fine or bearing
the cost of running an Industry training seminar for the benefit
of others in the Industry.
4.74 In a letter to CA of 7 January 2004,
Lord Warner, Parliamentary Under-Secretary of State for Health,
said that making complaints transparent via the MHRA website should
prove to serve as a disincentive of bad practice.
4.75 While any such increase in transparency
is welcomed, on its own it adds little value because the enforcement
system and penalties are weak or expensive and complicated to
operate. Publicising breaches of advertising regulations and codes
is not a new phenomenon. Complaints about advertising of medicines
have been published by both the PMCPA and the Advertising Standards
Agency (ASA) for some time and yet illegal practice is still occurring.
A combination of an effective penalties and enforcement system
and subsequent publication of case investigations and outcomes
is needed urgently.
4.76 The MHRA, together with other bodies
in this area, has failed repeatedly to protect the public from
misleading and inappropriate advertisements. The responsibility
for monitoring advertising and promotion should be co-ordinated
in a new, independent body with a single public interest objective,
armed with meaningful sanctions and, crucially, the will to use
them. An independent pharmaceutical industry advertising and information
regulator is urgently needed.
5. RECLASSIFICATION
OF MEDICINES
FROM PRESCRIPTION-ONLY
MEDICINE (POM) TO
PHARMACY (P) STATUS
5.1 The medicines reclassification process
illustrates the conflicts of interest, lack of transparency and
lack of accountability prevalent in the regulatory system. Reclassification
is driven by Industry demands and produces clear benefits for
the Industry. The benefits to the public are often less certain.
We are concerned that insufficient regard is paid to the public
interest and that the efficacy and long-term safety of reclassified
drugs is not sufficiently evaluated.
5.2 The MHRA website states that: "New
medicines are usually authorised for use as prescription only
medicines (POM). After some years' use, if adverse reactions to
the medicine are few and minor, it is possible that the medicine
may be safely used without a doctor's supervision. If there is
sufficient evidence of safety, a medicine may be reclassified
for sale or supply under the supervision of a pharmacist (P).
Pharmacy medicines which have been safely used for several years
may be suitable for general sale and may be reclassified as general
sales list (GSL). Reclassification of a substance normally follows
a request from the company which holds a marketing authorisation
for it. However, requests can be made by any interested party,
such as a professional body, or be initiated by the MHRA. Applications
to reclassify medicines are evaluated by the MHRA, with advice
from a suitable expert committee (currently the Committee on Safety
of Medicines (CSM)), as necessary. Where it is considered that
the proposed reclassification may safely be made, wide public
consultation, via the MHRA website takes place. Interested organisations
will be notified when a new consultation has been added to the
website. Responses to the consultation are evaluated by the MHRA
and advice is sought from the CSM only if a new safety issue is
raised during consultation. Following a successful reclassification
proposal, the change of legal status will be conferred on the
product that is the subject of the application for switching.
All other products with the same active substance will need to
make a separate application to follow suit."
5.3 The Government encourages wider availability
of medicines as soon as there is adequate evidence of safety in
use."[40]
As part of its "Choice" agenda, in the Building on the
Best Report (2004),[41]
the Government makes a commitment to doubling the rate of medicine
reclassifications ("switches")[42]
from five per year to 10 per year. Companies will receive 12 months'
exclusivity on trial data for products that are reclassified,
thereby preventing other companies from switching similar products
based on the data of another company.[43]
An additional incentive for Industry to switch products is that
over-the-counter (OTC) products can be advertised to the public,
enabling companies to communicate directly with a wider market.
Applying for a reclassification of status is particularly attractive
to companies when a product's patent is due to expire because
of the potential commercial opportunities associated with a switch.
Switching should be driven by proven safety and efficacy data
and not predominantly to boost Industry's profits or to shift
the cost of treatment from the NHS to the consumer.
5.4 The PAGB's briefing paper "POM
to P in a changing NHS" (www.pagb.org.uk) refers to "ambitious
switches" which "will not advance without substantial
cooperation between industry, health professionals and other stakeholders".
As such, a broad list of selected therapeutic targets for POM
to P reclassifications has been generated. This includes obesity,
erectile dysfunction, urinary incontinence, anxiety and migraine.
5.5 The decision to make the statin, simvastatin,
available in a 10 mg dose over-the-counter (OTC) in July 2004
did not fully take into account the potential consumer detriment
and uncertainties surrounding the potential benefits as a consequence
of that reclassification. In particular, no clinical trials have
been conducted in people deemed to be at moderate risk of coronary
heart disease (CHD) in OTC conditions. This effectively means
the public are being subjected to a world-first experiment given
that there is no evidence on the safety and efficacy of a 10 mg
daily dose of simvastatin in OTC conditions. The public has not
been alerted to this. Instead, simvastatin (brand name Zocor),
is promoted as being of definite public benefit whereby it is
assumed that the low dosage of 10 mg will not give rise to the
rare, but dangerous, side-effects reported in higher prescription-only
medicine (POM) doses.
5.6 Pharmacists supplying reclassified medicines
over-the-counter can end up having to choose between potentially
confusing protocols on such provision. This is because the manufacturer
produces one protocol pertinent to the switched drug (in this
case, Zocor), while the Royal Pharmaceutical Society of Great
Britain (RSPGB) and other relevant bodies (see below) may produce
another. In addition, further guidance on the treatment area more
generally may also be supplied to pharmacists by such bodies.
5.7 The MHRA states that the drug manufacturer's
protocol should be agreed with stakeholders such as the Royal
Pharmaceutical Society of Great Britain (RPSGB), the National
Pharmaceutical Association (NPA) and the Centre for Postgraduate
Pharmacy Education (CPPE),[44]
but these stakeholders do not need to have approved the protocol
for the switch to receive its authorisation for sale as OTC from
the MHRA.
5.8 Moreover, anecdotal evidence suggests
that as a result of receiving various guidelines, pharmacists
collate the information and draw up personalised/local versions
of protocols.
5.9 It is essential that effective monitoring
and evaluation takes place as part of the reclassification process.
However, it is unclear to what extent this occurs.
5.10 CA was not alone in opposing the Zocor
switch and yet the decision had all the appearances of a foregone
conclusion as there was no clear evidence that the concerns expressed
to the MHRA during the consultation process had been addressed.
5.11 While safety must be paramount, a possible
consequence of meeting safety criteria, by, for example, lowering
the dosage of a drug, could undermine that treatment's efficacy.
In the absence of demonstrable evidence of efficacy, public trust
in the regulator's ability to ensure drugs are effective before
they become available OTC could be undermined.
| Research conducted by CA indicates that 61% of consumers believe that the Government makes sure all conventional medicines work before the public can use them. (CA omnibus survey, April 2004).[45]
|
5.12 The conflict of interests inherent within the reclassification
process demands that there is greater transparency in the process
than at present to ensure this is carried out in the public interest
and that public health is protected.
5.13 The reclassification process needs to be urgently
reviewed. Government targets for the number of reclassifications
are inappropriate and the public interest should be the sole criterion
for approving a reclassification. It cannot simply be assumed
(as appears the case currently) that reclassification in and of
itself produces benefits to the public. Similarly, the MHRA's
efficiency should not be measured by the speed with which it handles
reclassifications but by its effectiveness in ensuring that reclassified
drugs are sufficiently safe and effective for OTC use.
5.14 Consultation periods should follow Cabinet Office
guidelines as a minimum and attempts should be made to elicit
views from all relevant stakeholders. Decisions must be based
on proven adequate safety and efficacy data, and these data must
be made publicly available. Reclassifications from prescription-only
medicine (POM) to pharmacy (P) status should be supported by the
development of one pharmacy protocol, approved by the Royal Pharmaceutical
Society of Great Britain, which should also be open to adequate
consultation before any decision is taken about reclassification.
5.15 Following reclassification, there should be a period
of close monitoring and evaluation to ensure that the public is
not being put at unnecessary risk and swift action should be taken
to address any problems.
August 2004
2
National Audit Office Report: safety, quality, efficacy-regulating
medicines in the UK (2003). Back
3
NAO Report, 16 January 2003: Themes and Comparisons in International
Medicine Regulation, paragraph 15, page 4. Back
4
MHRA Corporate Plan, Foreward, 2004. Back
5
Wanless, D Securing our Future Health: Taking a long Term View.
April 2002. Back
6
NAO Report, 16 January 2003: Themes and Comparisons in International
Medicine Regulation, paragraph 13. Back
7
National Audit Office Report: safety, quality, efficacy-regulating
medicines in the UK (2003), Executive Summary, page 3. Back
8
Patient information leaflets: sick notes? CA, June 2000. Back
9
Sless D and R Wiseman. Writing about medicines for people-usability
guidelines for consumer medicines information. Communication Institute
of Australia, 1997. Back
10
Promotion of prescription drugs: public health or private profit?
CA, July 2001; Toop L, Richards D, Dowell T, Tilyard M, Fraser
T, Arroll B. Direct to consumer advertising of prescription drugs
in New Zealand: for health or for profit? Report to the minister
of health supporting the case for a ban on DTCA. Christchurch:
University of Otago, 2003. Back
11
Meek, C. Marketing Drugs. Health Which? June, 2003. Back
12
National Institute for Health Care Management Research and Educational
Foundation (2002) "Prescription drug expenditures in 2001:
Another year of escalating costs", Washington DC. Back
13
source of figures BPAC / PHARMAC c/o personal communication with
Les Toop, Public Health Specialist, New Zealand, 17 August 2004. Back
14
Mintzes, B. Influence of direct to consumer pharmaceutical advertising
and patients' requests on prescribing decisions: two site cross
sectional survey, BMJ 2002;324:278-279. Back
15
Charatan, F. Bayer decides to withdraw cholesterol lowering drug.
BMJ 2001;323:359. Back
16
see also Jackson, T., BMJ:2003;326:1219 (31 May). Back
17
letter from MHRA to CA 1 April 2004. Back
18
CA. Drug advertising-what do people think? Survey results, 2002
www.which.net/campaigns/health/dtca/survey.html Back
19
Which? Who's injecting the cash? April 2003. pp 24-25. Back
20
www.guardian.co.uk/uk_news/story/0,3604,1062420,00.html Back
21
Children's book at centre of row over drug advertising campaign
BMJ Vol 327 23 August 2003. Back
22
Barnett, A. "Revealed: how stars were hijacked to boost
health company's profits", Sunday, 25 January 2004. Back
23
CA: Attitudes to Medicines' Promotions to the Public and General
Practitioners-a qualitative study with GPs, May 2004 (unpublished). Back
24
CA: Attitudes to Medicines' Promotions to the Public and General
Practitioners-a qualitative study with GPs, May 2004 (unpublished). Back
25
Mintzes, B. Influence of direct to consumer pharmaceutical advertising
and patients' requests on prescribing decisions: two site cross
sectional survey, BMJ 2002;324:278-279 (2 February). Back
26
SPCs failing-What DTB found "Failings in treatment advice,
SPCs and black triangles", Vol 39 No 4 April 2001. Back
27
CA: Attitudes to Medicines' Promotions to the Public and General
Practitioners-a qualitative study with GPs, May 2004 (unpublished). Back
28
CA: Attitudes to Medicines' Promotions to the Public and General
Practitioners-a qualitative study with GPs, May 2004 (unpublished). Back
29
19 July 2004, p22. Back
30
Doctor News (Jan 2003) "Drug watchdog comes under fire"
p 16. Back
31
Is Yasmin a "truly different" pill? DTB Vol
40: No 8, August 2002. Back
32
correspondence from MHRA to CA, dated 1 April 2004. Back
33
MHRA letter to CA, 1 April 2004. Back
34
Yasmin advert withdrawn-why and how? DTB Vol 41: No 3,
March 2003. Back
35
Yasmin advert withdrawn-why and how? DTB Vol 41: No 3,
March 2003. Back
36
See Annex A-Prescription Medicines Code of Practice Authority
Code of Practice on Advertising. Back
37
See Annex A-Prescription Medicines Code of Practice Authority
Code of Practice on Advertising. Back
38
PMCPA CASE AUTH/1539/12/03 "Voluntary admission by Lilly"
Conduct of representative, Code of Practice Review, May 2004. Back
39
See Annexes A and B for further details in relation to the PMCPA
and MHRA. Back
40
MHRA website 2004. Back
41
Building on the Best: choice, responsiveness and equity in the
NHS, Department of Health, December 2003. Back
42
"Switches" refer to reclassification of status from
Prescription-only Medicine (POM) to Pharmacy (P) or P to General
Sales List (GSL) ("POM-Over the Counter-OTC"). An application
to switch requires the approval of the Committee for Safety of
Medicines (CSM). Once a medicine is awarded OTC status it can
be advertised to the public. A key driver to switching can be
when a medicine's patent is due to expire. Back
43
Article 74a of Directive 2001/83/EC. Back
44
www.mhra.gov.uk/email dated 27 July 2004. Back
45
Promotion of Medicines CA Omnibus Survey 1,053 adults aged 15+
were interviewed, weighted to a total of 1,030 adults representative
of the adult population of Great Britain. Fieldwork took place
between 16 and 22 April 2004 using CAPI (Computer Aided Personal
Interviewing). (unpublished). Back
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