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Pharmaceutical Industry - A global industry
Pharmaceutical Industry - A global
industry
Pharmaceuticals are one of Britain’s leading
manufacturing sectors, bringing in a trade surplus of £3.4 billion in
2004. The value of UK pharmaceutical exports in 2005 was £12,2 billion,
more than £166,000 per employee. Yet we are low in the league of
medicines expenditure: we spend much less than many of our European neighbours
on the medicines we use. But our two largest pharmaceutical companies are among
the most successful in the world. In a global industry such as pharmaceuticals,
it is important to be in the Big League. An analysis of the world’s top
100 medicines reveals that, after the USA, Britain’s pharmaceutical
companies’ market share is more than all its European competitors
combined. Despite this success, British doctors are still reluctant to
prescribe new medicines – clinicians in other countries are far more
likely to prescribe medicines that have come on to the market in the past five
years.
Pharmaceuticals and the UK economy
Prescription
medicines are the subject of Government controls and intensive competition.
Pharmaceutical prices have grown at a slower rate than consumer prices as a
whole and in real terms, are 21 per cent cheaper than ten years ago. Within the
UK economy, pharmaceuticals are consistently in the top three industrial
sectors in terms of trade surplus. And the industry is a major employer, with
around 73,000 people employed directly. The value added per employee is rising
year by year. The pharmaceutical market is highly fragmented: only one company
has a ten per cent share of the UK market, most of the rest are far smaller. Of
the major medicines sold in the UK, around half were developed in British
laboratories.
Pharmaceuticals - Research and
Development
Research and development lies at the heart of the
pharmaceutical industry. It invests 30 per cent of its sales in research, and a
quarter of the entire research expenditure by the UK manufacturing sector is
funded or carried out by the pharmaceutical sector. Research and development
expenditure by the pharmaceutical industry in Britain amounts to more than
£3 billion, or around £9 million a day.
Pharmaceuticals
and the NHS
With the cost of the NHS rising, the medicines bill
remains at about 13 per cent of the total, despite a constant growth every year
in the number of prescriptions issued. More than 825 million prescriptions are
dispensed every year, at an average cost of around £11 each. This
represents remarkable value for money, in that medicines often reduce or
eliminate the need for more costly inpatient treatment in hospital. The
industry provides the nation's medicines at a cost of only 56 p per person per
day. A breakdown of the statistics by therapeutic group shows that a large part
of the industry’s investment in medicines goes into cancer, heart disease,
stroke and disorders of the central nervous system. Medicines have made a
significant contribution to the reduction in the use of hospital beds that has
taken place over the past 30 years, meaning significant savings for the NHS.
Information from
www.abpi.org.uk
The Influence of the Pharmaceutical
Industry (Fourth Report of Session 2004–05)
Medicines
contribute enormously to the health of the nation. The discovery, development
and effective use of drugs have improved many people’s quality of life,
reduced the need for surgical intervention and the length of time spent in
hospital and saved many lives. Our consumption of drugs is vast and is
increasing. About 650 million prescriptions are written each year by GPs alone.
Medicines cost the NHS in England over £7 billion every year, 80% of
which is spent on branded (patented) products. The industry which has produced
these drugs has understandably been described as “world class and a jewel
in the crown of the UK economy”. It is the third most profitable economic
activity after tourism and finance. While the United States is the
industry’s largest market and is the site of most drug research and
development, the UK industry, nevertheless, has a remarkably impressive record.
It is a centre of world class science, accounting for 10% of global
pharmaceutical R&D expenditure. It has been estimated to fund 65% of all
health-related R & D in the UK.
However, there are disadvantages in
the increasing use of and reliance on medicines. The inappropriate or excessive
use of medicines can cause distress, ill-health, hospitalisation and even
death. Adverse drug reactions are responsible for about 5% of all admissions to
hospitals in the UK.
The interests of pharmaceutical companies and those
of the public, patients and the NHS often overlap but they are not identical.
For the industry, medical need must be combined with the likelihood of a
reasonable return on investment. An effective regulatory regime to ensure that
the industry works in the public interest is essential. Unfortunately, the
present regulatory system is failing to provide this. The system is at times
frustrating, arguably with excessive attention to unimportant detail, but it
is, as we describe below, insufficiently effective.
The Department of
Health has for too long optimistically assumed that the interests of health and
of the industry are as one. This may reflect the fact that the Department
sponsors the industry as well as looking after health. The result is that the
industry has been left to its own devices for too long. It may be relevant that
this is the first major select committee inquiry into the pharmaceutical
industry for almost one hundred years – the last was undertaken by the
Select Committee on Patent Medicines which reported in August 1914.
The
consequences of lax oversight is that the industry’s influence has
expanded and a number of practices have developed which act against the public
interest. The industry affects every level of healthcare provision, from the
drugs that are initially discovered and developed through clinical trials, to
the promotion of drugs to the prescriber and the patient groups, to the
prescription of medicines and the compilation of clinical guidelines. We heard
allegations that clinical trials were not adequately designed – that they
could be designed to show the new drug in the best light – and sometimes
fail to indicate the true effects of a medicine on health outcomes relevant to
the patient. We were informed of several high-profile cases of suppression of
trial results. We also heard of selective publication strategies and
ghost-writing. The suppression of negative clinical trial findings leads to a
body of evidence that does not reflect the true risk:benefit profile of the
medicine in question. Guidance produced by NICE and others relies on the
published evidence. If all the evidence is not published, or if negative
findings are hidden, accurate guidance cannot be issued and prescribers cannot
make truly evidence-based decisions.
Once licensed, medicines are
intensely promoted to prescribers. The very high costs of developing a new drug
make it vital that a company recoups its costs as quickly as possibly after
licensing. Coupled with company-sponsored information from medical journals and
supplements, ‘medical education’ materials, advertisements and
sponsorship to attend conferences, workshops and other events, it is little
wonder that prescribing practices are affected. GPs are particular targets;
they have more prescribing freedom than hospital specialists and their
prescribing practices are not limited to hospital formularies. Promotion of
medicines to patients and links between drug companies and patient
organisations may add to this problem, leading patients to demand new drugs
from their doctors. The problem is far less to do with any particular activity;
rather the volume may distort prescribing practice. At the heart of the problem
may be the trend for the industry to become ever more driven by its marketing
force.
The most immediately worrying consequence of the problems
described above is the unsafe use of drugs. Over-prescription of the COX-2
inhibitors, Vioxx and Celebrex, has been linked to thousands of deaths and many
more cases of heart failure. These case illustrate a series of failures.
Manufacturers are known to have suppressed certain trials for these drugs in
the US and may have done the same in the UK. In addition, there were
inadequacies in the licensing and post-marketing surveillance procedures and
excessive promotion of the drugs to doctors.
What has been described as
the ‘medicalisation’ of society – the belief that every problem
requires medical treatment – may also be attributed in part to the
activities of the pharmaceutical industry. While the pharmaceutical industry
cannot be blamed for creating unhealthy reliance on, and over-use of,
medicines, it has certainly exacerbated it. There has been a trend towards
categorising more and more individuals as ‘abnormal’ or in need of
drug treatment.
The industry is by no means solely to blame for the
difficulties we describe. The regulators and prescribers are also open to
criticism. The regulator, the Medicines and Healthcare products Regulatory
Agency (MHRA), has failed to adequately scrutinise licensing data and its
post-marketing surveillance is inadequate. The MHRA Chairman stated that trust
was integral to effective regulation, but trust, while convenient, may mean
that the regulatory process is not strict enough. The organisation has been too
close to the industry, a closeness underpinned by common policy objectives,
agreed processes, frequent contact, consultation and interchange of staff. We
are concerned that a rather lax regime is exacerbated by the MHRA’s need
to compete with other European regulators for licence application
business.
Inappropriate prescription of medicines by GPs is of
particular concern. Some have prescribed SSRIs, for instance, on a grand scale.
This is in part due to inadequacies in the education of medical practitioners
which has meant that too few non-specialists are able to make objective
assessments of the merits of drugs and too many seem not to recognise how
little is known about the properties of a drug at the time of licensing,
particularly about its adverse consequences. However, many prescribers have
behaved responsibly and with restraint, which makes those who have not, all the
more culpable. The constraints in place for hospital doctors do not apply to
GPs. Drug companies are criticised for giving hospitality and recruiting
‘key opinion leaders’, but the prescribers must be equally to blame
for accepting the hospitality and some ‘key opinion leaders’ for
lending their names to work they did not produce, often for very considerable
sums.
The Government, like the MHRA, has tended to assume that all is
for the best. It states that there is no better alternative system. We agree:
pharmaceutical companies will inevitably continue to be the dominant influence
in deciding what research is undertaken and conducting that research,
publishing it and providing information to prescribers. This does not, however,
mean that no changes are required.
Our recommendations cover several
areas of concern, in particular the licensing process. The key to improvement
is greater transparency so that medical practitioners, experts and the public
can make an independent assessment of the evidence. We welcome the
industry’s decision to establish a clinical register but it is important
that it should be independent. We make recommendations to this effect. Greater
transparency is also fundamental to the medicines regulatory system. There has
to be better public access to materials considered by the MHRA prior to
licensing.
The aim of new drugs should be real therapeutic benefit for
patients. Clinical trials should focus on using health outcomes that are
relevant to patients. To achieve this we recommend better communication between
the MHRA and companies early in the early stages of the development of a drug.
Improvements in the post-licensing surveillance of medicines are also badly
needed. This will require systematic appraisals of medicines.
We
recommend that more research be undertaken into the adverse effects of drugs,
both during drug development and medicines licensing. The Government should, as
a matter of urgency, fund research into the costs of drug-induced illness. We
recommend that the MHRA find ways of ensuring greater restraint in medicines
promotion, particularly soon after launch. There should also be strengthened
guidelines requiring the declaration of links between pharmaceutical companies
and patient groups. In view of the failings of the MHRA, we recommend a
fundamental review of the organisation in order to ensure that safe and
effective medicines, with necessary prescribing constraints, are
licensed.
It is extraordinary that there are stricter controls on
hospital specialists prescribing than on GPs. We recommend tougher restrictions
be placed on what non-specialists can prescribe and greater vigilance to guard
against excessive or inappropriate prescribing. Nurse and pharmacist
prescribing will need to be carefully monitored. Doctors, in particular
‘key opinion leaders’, should be obliged to declare significant sums
or gifts they receive as hospitality. Professional bodies should maintain a
register of these declarations.
Government has rightly sought to assist
industry, but it needs to do more to help pharmaceutical companies conduct
research. They have to cope with confusing ethics approval procedures as well
as relatively few adequately trained medical researchers or specialist research
facilities. The NHS should build on the success of the National Cancer Research
Network to facilitate research for other treatments.
The Department of
Health has not only to promote the interests of the pharmaceutical industry but
also the health of the public and the effectiveness of the NHS. There is a
dilemma here which cannot be readily glossed over. The Secretary of State for
Health cannot serve two masters. The Department seems unable to prioritise the
interests of patients and public health over the interests of the
pharmaceutical industry. We therefore recommend that sponsorship of the
industry1 pass from the Department of Health to the Department of Trade and
Industry.
The UK pharmaceutical industry is in many ways outstanding. We
trust that our recommendations will not only protect health but also help the
industry. It is not in the long term interests of the industry for prescribers
and the public to lose faith in it. We need an industry which is led by the
values of its scientists not those of its marketing force. In making our
recommendations we were very impressed by the comments of Sir Richard Sykes:
“Today the industry has got a very bad name. That is very unfortunate for
an industry that we should look up to and believe in, and that we should be
supporting. I think there have to be some big changes.”
http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf |
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