Andrew Platten MSc, MRPharmS, DipM, MCIM, Head of Consultancy at HealthGain Solutions

Introduction The pace of change within the NHS has shown no sign of abating during 2003 with new contracts of employment agreed with hospital consultants and GPs and negotiations underway on a new pharmacy contract. The pharmaceutical industry has not escaped the winds of change either with the Pharmaceutical Price Regulation Scheme (PPRS) due for renewal in April 2004 initial discussions are being held on its successor and proposed changes to the reimbursement of generic medicines have also been consulted on.

January January finally saw the publication of the much delayed Delivery Strategy for the Diabetes National Service Framework and, unlike earlier NSFs, it gave flexibility for local NHS organisations to set their own targets within a national framework. The key elements proposed in the Delivery Strategy are that Primary Care Trusts (PCTs) should consider:

• setting up a local diabetes network, or similarly robust mechanism, which involves identifying local leaders and appointing and resourcing network managers, clinical champions and a person(s) with diabetes to champion the views of local people
• reviewing the local baseline assessment, establishing and promulgating local implementation arrangements with a trajectory to reach the standards
• participating in comparative local and national audit
• undertaking a local workforce skills profile of staff involved in the care of people with diabetes and developing education and training programmes with the local Workforce Development Confederation

January also saw many pharmacists sit up and take note as the Office of Fair Trading issued its report on community pharmacy and recommended a liberalisation of the market to enable more pharmacists to obtain NHS contracts. This drew support from many of the large multiple pharmacy chains who would be in a position to take advantage of this new arrangement but the majority of independent pharmacies were opposed to the changes as they feared it would force them to close and thus reduce patient choice. The government acknowledged the report and said that it would issue a response later in the year.

February February saw the announcement from the British Medical Association and the NHS Confederation that after 18 months of negotiation an agreement had been reached on the new GMS contract for GPs. Unfortunately when GPs studied the small print many of them realised that they would be worse off financially under the new contract and thus it was not voted in.

The Department of Health also issued guidance on supplementary prescribing for nurses and pharmacists this month and this will undoubtedly have a long term impact on the pharmaceutical industry. The NHS aims to have 10,000 nurses and 1,000 pharmacists trained as Supplementary Prescribers by the end of 2004 with this the historical precedent of the GP or Hospital Consultant holding all of the power when making prescribing decisions will cease. Marketers and sales teams will need to develop new skills and materials to enable them to engage and influence these new prescribers.

March March ended with the publication of the final Performance Indicator Set for PCTs for 2003/4 and these provide some opportunities for the pharmaceutical industry to work in partnership with PCTs and help them achieve some of their targets. The indicators that are of particular interest to the pharmaceutical industry include:

• Prescribing of atypical antipsychotics
• Death rates from circulatory diseases, aged under 75
(change in rate)
• Death rates from cancer, aged under 75 (change in rate)
• Teenage Pregnancy: Conceptions below age 18 (change in rate)
• Diabetes services baseline assessment
• CHD Audit
• Prescribing rates of antibacterial drugs
• Prescribing rates for drugs acting on benzodiazepine receptors
• Generic prescribing

A full breakdown of the performance indicator set is available from the Commission for Health Improvement website at www.chi.org.uk

April
Details of a potentially new important customer group appeared in April as the Department of Health published ‘Liberating the Talents – Implementing a scheme for Nurses with Special Interests in Primary Care’. The document describes examples of many nurses with special interests including:

• Colorectal Nurse Specialist
• Sexual Health Development Nurse
• Heart Failure Nurse
• Epilepsy Specialist Nurse
• Clinical Nurse Specialist, Pain Management

In the foreword to the document Dr David Colin-Thome, National Director for Primary Care, noted that ‘the work of GPs with special interests has been widely adopted as a way to maximise the wealth of skills and knowledge in the primary care medical workforce.’ He went on to state that ‘doctors are only part of the team’ and ‘the successful development of any practitioner in a specialist role will depend on their effective integration within the team. PCTs should ensure that the expansion of primary care services takes a whole system approach, maximising the potential of all primary care staff to take on new roles and recognising their interdependency.’

May
In May, 29 hospitals were invited to form the first wave of applications to become Foundation Trusts. In order to be eligible to apply for foundation status the NHS trusts must:

• Hold a ‘three star’ rating in the annual NHS performance ratings and maintain this throughout the application process
• Prove that they have strong leadership and a commitment to modernising services for the benefit of patients and local communities
• Have the support of staff and other local stakeholders for their vision for reform

The successful applicants will become Foundation Trusts from April 2004 and full details on this new type of hospital can be found at www.doh.gov.uk/nhsfoundationtrusts. The rules governing foundation trusts allow members of the local community to become ‘members’ of the trust and have a say in the direction and planning of the hospitals services. Foundation Trusts are free to set their own terms and condition of employment as well as raise additional capital, within a pre-determined limit, from any source to develop the services they offer. It is possible in the future that Foundation Trusts could form partnerships with the pharmaceutical industry to enhance the development of services in defined clinical areas where they have a mutual interest. June June 12th saw the departure of Alan Milburn from the cabinet to ‘spend more time with his family’ and the subsequent appointment of Dr John Reid as the Secretary of State for Health. Although bringing with him a reputation as a hard negotiator one of the first things Dr Reid did was to re-open discussions with hospital consultants on their new contract and break the deadlock that had existed since Alan Milburn had tried to impose the contract after it had been voted out. June also saw movement on contract negotiations with another group of doctors, GPs, with the new GMS contract being voted in on 20th June with nearly 80% of those GPs who voted agreeing to the contract. The new GMS contract now means that PCTs will contract with the GP practice and not individual GPs as before and it is focused on three key elements:

The successful applicants will become Foundation Trusts from April 2004 and full details on this new type of hospital can be found at www.doh.gov.uk/nhsfoundationtrusts. The rules governing foundation trusts allow members of the local community to become ‘members’ of the trust and have a say in the direction and planning of the hospitals services. Foundation Trusts are free to set their own terms and condition of employment as well as raise additional capital, within a pre-determined limit, from any source to develop the services they offer. It is possible in the future that Foundation Trusts could form partnerships with the pharmaceutical industry to enhance the development of services in defined clinical areas where they have a mutual interest.

June June 12th saw the departure of Alan Milburn from the cabinet to ‘spend more time with his family’ and the subsequent appointment of Dr John Reid as the Secretary of State for Health. Although bringing with him a reputation as a hard negotiator one of the first things Dr Reid did was to re-open discussions with hospital consultants on their new contract and break the deadlock that had existed since Alan Milburn had tried to impose the contract after it had been voted out.

June also saw movement on contract negotiations with another group of doctors, GPs, with the new GMS contract being voted in on 20th June with nearly 80% of those GPs who voted agreeing to the contract. The new GMS contract now means that PCTs will contract with the GP practice and not individual GPs as before and it is focused on three key elements:

• Essential services – these are the ‘must do’ services which are defined as ‘Management of patients who are ill or believe themselves to be ill … for the duration of that condition, and … patients that are terminally ill
• Enhanced services – these are additional voluntary services that GPs can provide in agreement with the PCT. They are split into national enhanced services e.g. services to the homeless which have a nationally agreed set of criteria and local enhanced services which enable PCTs to set local criteria based on the needs of their population and negotiate locally with GPs on the terms and conditions for delivery.
• Quality payments – Annex A of the new GMS contract lists a set of standards for improving the quality of services in key areas e.g. CHD, diabetes. Each disease area has a set of points that can be achieved and for each point achieved the GP practice will receive a payment of £75 in 2003/4 rising to £105 in 2004/5. There are a possible 1050 points to be achieved and it is likely that this element of the contract could account for between 30-50% of a GPs total remuneration.

The new GMS contract provides a myriad of opportunities for the pharmaceutical industry to help GPs achieve increases in their income whilst also showing the positive health outcomes of their products in the disease areas linked to the quality payments.

July On July 17th the government issued it’s response to the OFT Report on the de-regulation of community pharmacy services. Whilst accepting that the OFT had made a strong case that the current control of entry rules impeded competition the government stated that a complete de-regulation of the existing system was not viable at the moment. Instead a compromise arrangement was made with those pharmacies that met the following criteria being given exemption from the existing regulations:

August August 29th heralded yet more pharmacy focused NHS policy with the publication of a consultation paper entitled ‘Proposals to reform and modernise the NHS (Pharmaceutical Services) Regulations 1992’ which invited formal feedback on the proposals outlined in ‘A Vision for Pharmacy in the New NHS’.

September September saw the publication of two discussion/consultation papers that will impact the pharmaceutical industry in 2004 and beyond.

1. The Pharmaceutical Price Regulation Scheme – A Discussion Paper. This document invited views from the NHS, the pharmaceutical industry and other interested bodies on the possible structure of the agreement to replace the PPRS in April 2004. Views were sought on the following suggestions by the end of October:

• Rolling forward the 1999 PPRS agreement without change
• Amending certain parts of the current agreement through negotiation
• The potential for complete deregulation
• Any alternate proposals

At the time of writing it is unclear how these discussions will develop but whatever the outcome it will have an impact on the future promotion of pharmaceuticals and thus the role of the medical representative.

2. Arrangements for the Future Supply and Reimbursement of Generic Medicines for the NHS. This consultation document sought views on the UK generics market and once the final arrangements have been agreed they will replace the current ‘Maximum Price Scheme’ for generic medicines that has been in place since 2001. Any future system will have to be based on the following principles:

• Maintain and improve the current quality of service to patients
• Reimburse community pharmacists , overall, as closely as possible to what they actually pay for the medicines they dispense under the NHS
• Have transparent prices
• Support a competitive pharmaceutical market
• Secure value for money for the NHS
• Ensure arrangements for the future reflect the current supply chain and future developments

The outcome of these discussions will have a big impact on many community pharmacists who currently secure a proportion of their income from successfully negotiating generic prices below those in the drug tariff. It will be important to ensure that these pharmacies are fairly remunerated under any new pharmacy contract and able to maintain a viable level of income from alternative sources.

September also saw the publication of ‘Choice, responsiveness and equity in the NHS and social care’ which was a national consultation paper aimed at identifying the best way of ensuring patients and carers views are heard within the NHS. The consultation ran until the middle of November and it’s findings will have a major impact on how PCTs and other NHS organisations plan services in the future.

October The new consultant contract was agreed on October 20th with 60.7% voting in favour. It has secured the services of consultants for the NHS for a minimum of 40 hours per week before any private work is undertaken and in return the consultants gained concessions on evening and weekend work and the starting salary for a new consultant has risen from £54,000 to over £65,000.

Conclusion 2003 has been a very busy yeaAugust August 29th heralded yet more pharmacy focused NHS policy with the publication of a consultation paper entitled ‘Proposals to reform and modernise the NHS (Pharmaceutical Services) Regulations 1992’ which invited formal feedback on the proposals outlined in ‘A Vision for Pharmacy in the New NHS’.

By Clare Willis, Senior Training Consultant, Speak First

THE ABILITY TO DEVELOP GOOD WORKING relationships with a wide variety of people is a key skill for the medical sales professional. There are those people with whom you feel an instant rapport; others present much more of a challenge. This article suggests a method of analysing those difficult relationships, identifying a likely cause of the problem, and developing a strategy to enable you to work together more easily.

One of the keys to success in relationship building is flexibility – the ability to understand, react and adapt to very different behavioural styles. Ever since thinkers got to grips with human differences, they have categorised people within behaviour types; researchers have consistently identified four distinct groups.

We have synthesised the research and given light-hearted but memorable labels to the four personality types – Lion, Owl, Horse and Monkey. No animal is better or worse than any other – but they all have their differences. Consider the people you do business with. Based on the descriptions of characteristics, you should be able to find the animal that best fits their nature and approach. You should also be able to identify yourself in animal terms.

LIONS

Lions are autocratic, independent and strong willed. Authoritative and goal-oriented, Lions leap to challenges, take decisive action and seek to dominate the problem-solving process. At their most extreme, Lions are intolerant of other people’s advice and feelings, wanting immediate results and failing to listen or co-operate.

Best at: Being in control Worst social feature: Dictatorial Response to stressful situation: “If you can’t stand the heat, get out of the kitchen.”

Behaviour under stress: Your instinct will be to dictate and you will appear: critical, abrupt, uncooperative and aggressive.

To increase your flexibility:
• Slow your momentum to come across as more relaxed
• Demonstrate active listening
• Allow more time for discussion
• Acknowledge feelings as well as facts.

How to deal with Lions:
• Present the facts concisely, logically, quickly
• Emphasise benefits, time frames, results
• Focus on facts, not feelings
• Ask how they would solve the problem.

HORSES

Horses are caring creatures, at the other end of the scale to the Lion. They value close personal relationships and actively listen to the opinion of others. Horses are steady, calm and supportive, working slowly and cohesively while avoiding conflict. Qualities of patience, loyalty and consideration are the flipside of passivity, dependency and indecision.

Best at: Supporting others Worst social feature: Submissive Response to stressful situation: “OK, if that’s the way you must have it, we’ll try it.” Behaviour under stress: Your instinct will be to withdraw and you will appear: indecisive, hesitant, submissive, slow to act.

To increase your flexibility:
• Speak up more often
• Voice your disagreements
• Say ‘no’ occasionally
• Be willing to reach beyond your comfort zone.

How to deal with Horses:
• Give them time to talk about their concerns and feelings
• Discuss options; don’t pressurise them
• Show you’ve thought about the impact of your ideas on others
• Remember that they have a hard time saying ‘no.’

MONKEYS

Monkeys are sociable and spontaneous beasts, jumping rapidly between activities. Intuitive and emotional, monkeys love to be involved. They tend to dream the dramatic, taking risks and persuading others to follow the rainbow. At best they are open and enthusiastic visionaries: at worst impulsive and inconsistent time wasters.

Best at: Socialising Worst social feature: Confrontational Response to stressful situation: “Listen you idiot, I’m fed up with the way you’re treating me.”

Behaviour under stress: Your instinct will be to confront and you will appear: manipulative, impetuous, erratic, wasteful of time.

To increase your flexibility:
• Listen more; don’t interrupt
• Concentrate on the task
• Allocate more time for checking, verifying, specifying and organising
• Work on following through.

How to deal with Monkeys:
• Allow time for social chat
• Use stories, examples, humour and enthusiasm
• Show that others are in favour of your ideas
• Remember that they prefer to ignore unpleasant facts.

OWLS

Owls attend to detail and tend to have serious personalities. Accuracy is more important than imagination or deadlines. Driven by data, owls are intellectual, structured and organised animals, devoted to getting it right. Cautious and compliant with authority, they like to work methodically through objective tasks in a controlled environment. This can make them resentful in the face of change.

Best at: Processes and Systems Worst social feature: Withdrawn Response to stressful situation: “I can’t help you any further - do what you want.” Behaviour under stress: Your instinct will be to withdraw and you will appear: resistant to change, unresponsive, slow to act, overdependent on data and facts.

To increase your flexibility:
• Concentrate on high-priority issues
• Focus on the bottom line
• Share your feelings and points of view
• Try to adjust more readily to change and disorganisation.

How to deal with Owls.
• Give them time to think about processes, procedures, problems
• Be accurate; include statistics
• Allow them to work through the details
• Tie new ideas into old ones.

The nature of the beast Of course, no-one is a pure lion any more than they are a thoroughbred horse. Each of us is an amalgam of characteristics, creating a unique individual, yet we have primary characteristics which assign us to one of the four types. These dominant characteristics come to the fore in a crisis. Under pressure, we revert to type, minimising balancing characteristics while accentuating our main traits.

Identifying the characteristics of each animal has three main benefits. It enables you to understand and use your strengths while minimising your weaknesses; to build understanding of why colleagues and stakeholders act as they do; and provides strategies for acting on this knowledge and developing greater rapport with a wider range of people.

Being more aware of your own instinctive behavioural style is the first step in building better relationships, and can help you to develop conscious strategies to build rapport. If you are a detail-loving owl, your first instinct will be support your case with statistics such as the results of the latest clinical trials. But if you are talking to a horse, you might be more persuasive if you use real-life examples of how patients have benefited from your drug. Monkeys will like to know that respected colleagues have had good results with the product; lions want to focus on the bottom line. So, you need to adapt your approach to suit the person you’re talking to - even if it means treating other people differently from how you yourself like to be treated.

Knowing the nature of the beast might just give you the edge when dealing with the assertive consultant, the detail-loving pharmacist or the sociable practice manager.

This double special edition of the MATRIX provides a simple checklist of facts about the new GP contract. Given that this is time for New Year’s Resolutions, the new GMS Contract represents a more of a Revolution of Healthcare Agenda’s and implications for the Pharmaceutical Industry.

10 CONTRACT FACTS

1. Every practice will have 2 x signed PROSCRIBED CONTRACTS. One will be kept at the GP practice and one will be kept at the PCT. These contracts finally pin down what GPs will be doing and more importantly what they will be getting paid to do.

THINK POINT PF: Now think about this. Why has the Government brought in a Contract now ? This is as much to do with control as it is to do with care and delivery. Remember that previous to the contract, the GPs working from a red book are acting as self-employed practitioners. Hence, they can pretty much do what they want. Hence when the pressure comes on from the health Authority (or the prescribing adviser) they can to a certain extent say ‘to hell with you !!’ give or take. But now, with a contract, all sorts of declarations, promises and undertakings will be involved. Hence, it is only with the presence and signing of a contract that one can be in ‘breach’ of contract.

2. INR Monitoring will be an enhanced service. Specialist activities such as INR monitoring will be classified as a Nationally Enhanced Service (NES). Hence GPs will not get paid as part of routine work anymore. They will have to choose to ‘opt in’ or ‘opt out’ if this service.

THINK POINT PF: This is 1 example of a change that could make or break the NHS. For example, patients on warfarin (anticoagulation) need regular INR monitoring. Under the new GP contract, GPs will not be paid to do this. So many of them will be ‘opting out’ of this service. Having said that, the PCTs responsibility is to provide INR monitoring to the patient (it’s not the GPs responsibility). So who will do it ? Well at the moment, many PCTs are hoping GPs will just ‘do it’. Many GPs will now be handing in their ‘I withdraw from INR monitoring’ letter and come April 2004 the PCTs will be frantically trying to get someone to do it. 2 Further interest points : PCTs may out source (like out-of-hours) or certain GPs may take up INR monitoring as an enhanced service. Hence patients will be going to different surgeries for different types of blood tests. Interesting.

3. Minimum Investment Guarantee (MPIG). The global sum makes up about 2/3 of the practice finances. The remaining 1/3 comes from infamous ‘points’ to make prizes. To try and ensure no-one loses out, the government have promised a ‘minimum investment’. Hence if a practice is not achieving minimum points they won’t earn anything less than they earned last year.

THINK POINT PF: This minimum investment guarantee was a carrot. It was the final push which led to the ‘yes’ vote which led to where we are today. One key effect of the MPIG is that once the GP contract comes into effect, if practices are scoring poorly on the points, they wont lose all the 1/3 income. The government have promised that overall income will be similar to previous years until they start achieving ‘points’ over and above minimum targets (25%). Once this has occurred, income will vary depending upon ‘points’ scored.

4. How many points ? There are a total of 1050 points. 550 of these are clinical points across 10 disease areas. The remaining 500 points are administrative practice points related to management, audit, practice records and documentation and patient experience related measures. The 10 disease areas are not split equally as can be seen below.

Secondary Prevention of CHD        121 points
Diabetes Mellitus                                 114 points
Hypertension                                      105 points
Asthma                                               72 points
COPD                                                 45 points
Mental Health                                       45 points
Stroke /TIA                                       31 points
Epilepsy                                              16 points
Cancer                                               12 points
Hypothyroidism                                     8 points

5. And what are they worth ? Each point is worth £75 for 2004/5 which goes up to £125 the following year and then up to £300 per point the year after that.

THINK POINT PF: Much fuss has been made about these points – and rightly so. There are some important principals of care here. We know that patients with disease are often showing poor control despite prescribing and management. Hence this system will focus more on outcomes rather than just activities. 3 Specifics : firstly each of the disease points is made up of targets which need to be achieved (ie) cholesterol below 5mmol/L. But the cholesterol target reappears many times (Secondary Prevention CHD, Diabetes, Hypertension and Stroke/TIA). Hence by investing in ‘cholesterol management’ a practice can hit a target ACROSS diseases rather than THROUGH them. This is very important. It’s like writing an essay. The first marks are always the easiest. The same applies for achieving these points. Rather than trying to treat all the targets for 1 disease, GPs will be more efficient if they treat 1 target across many diseases. Secondly, there are minimum and maximum % thresholds. For example, the cholesterol <5 mmol/L target has a minimum of 25% and a maximum of 60%. This means that no payments are made until at least a quarter of the patients in the register have a cholesterol below 5mmol/L But interestingly, once 60% of patients have achieved target, the GP does not get paid for getting more patients to target ! So will it be worth while bothering ? Finally and really a point for us all to bear in mind. The ‘family doctor’ is on the way out. The idea that the GP would understand your problems, look holistically at your circumstances and view you with your illness may be gone. Because the government want targets, targets, targets. This may not be a bad thing. But 1 of the golden rules of medicine is ‘treat the patient not the blood test’. Rightly or wrongly, that’s now out of the window.

6. What if they score too many points ? If GPs get very high outcomes – then they must be paid for achieving them. That’s what the paperwork says. That’s what the government promised.

THINK POINT PF: This is a very real concern. GPs will be asked what their aspirations are (many of them will say ‘to retire’!) So of the 1050 points, how many do you think you will get ? Or how many do you think you want to work towards. It’s just a guide and they don’t get penalised for not achieving them. But they do get some monies up front (and the rest when/if they achieve the points). You will find many practices not going for 1050, but will aim for say 700-900 points. If they don’t get there – no problem. No penalties. Just payment for targets achieved.

7. What about funding for enhanced services ? GPs will be opting in and out of services as we read this paper. The point is, they are being paid for extra services that they may want to do (say minor surgery). Some GPs don’t want to do minor surgery. So they don’t need to. But what happens in none of them want to do minor surgery ?

THINK POINT PF: There is a worry about enhanced services – will there be enough money to pay for this ? There must be otherwise the PCT will have to pay hospitals to do it !! The GPs will really have to stick to their guns when they ‘refuse’ to do work. What is interesting is the fact that the PCT has responsibility for finding and commissioning the delivery of care – not the GP. Hence we are going to see some real fragmentation (and arguably specialisation) of care delivery from primary care levels.

8. What was all the fuss about pensions ? Much of the disgruntled arguing has been over issues such as pensions and premises rather than clinical quality indicators. One thing we will now see is GPs putting all incomes through their practice accounts to prevent monies and funds from being sucked out of their pensions.

9. A Note on the Sick Note ! Demand Management points out the bulk of sick certification should move out of the GP’s remit and to that of occupational health. So you wont be seeing your GP anymore for a sicky!

THINK POINT PF: The problem with this appointment is that the patient would never have come to the GP for their illness unless they wanted the sick note !! Hence we are wasting doctors time for a piece of paper (that we often have to pay for anyway). I think we will still have to pay for it though . . .

10. What about dispensing doctors ? No changes and no funds have been taken away from dispensing doctors. They have kept interference to a minimum. The points and prizes of the quality framework still apply.

THINK POINT PF: The next time you catch up with a GP ask them about premises and work being done to the premises. It’s a sticky point now. If a practice/GP had an improvement grant/work planned which was approved before September it may go through – but some won’t. In fact from now on, GPs will not get rent to pay for this. Money has become very tight for premises. Why ? The government needed to raid premises budget for the MPIG (see above). So they will need my prescribing incentives to help to pay for this now (and also their staff see next)

11. Staffing and the new GP contract ? Arguably one of the most significant changes to the daily finances will be the way in which staffing is budgeted within practices. Until recently the government has reimbursed 75% on staff that practices employ. Well under the new GP contract – this has gone - completely! So now the GP will have to pay for each and every staff member from his own pocket.

THINK POINT PF: Why is this ? Money follows the patient not the staff. So funding is based on patient outcomes whether you have 1 nurse or 10 nurses. What’s more, for every £1 the GP spends on staff they need to add +11p for NI contributions and +14p pension contribution. So they really do need hence to look at what staff are doing. Under a current system, employing 2 x G-grade nurses and 2 X Hgrade nurses just to do BP and urine will be a complete waste of money!! Expect to see receptionists trained to NVQ doing BP,urine, health checks etc and also the employing of medical students (cheap if not free and no NI and pensions to think about). The world is changing . . .

THE TREATMENT OPTIONS that are available for treating cancer are surgery, radiation therapy, chemotherapy, immunotherapy, hormonal therapy, laser treatment, and biological therapies. Of all these forms of treatment for cancer, vaccines seem to hold great promise because of their efficacy and minimal side-effects profile. The mechanism of action is to teach the body’s immune system to identify cancer cells and destroy them. In the U.S., the National Cancer Institute and many biotech companies are involved in the research and development of cancer vaccines. According to estimates, more than 50 vaccines are undergoing advanced trials for cancer. The major biotech companies, besides the National Cancer Institute, involved in research and trials include Cell Genesys, Biomira, Antigenics, Dendreon, Genzyme Molecular Oncology, VaxGen, and Corixa.

History

History Early 90s saw cancer vaccine technology come into focus with most companies starting out research with antigen-specific cancer vaccines or whole cell vaccines. Cell Genesys and Biomira were one of the earliest companies to start research into cancer vaccines.

Research on cancer vaccines has been continuing for a long time and scientists have approached it by isolating selected antigens that are differentially expressed on tumour cells and not so well expressed on normal cells. Scientists use either the whole cancer cell or synthetically manufacturing components of the transformed cell, using recombinant protein to develop tumour-associated antigen.

Technology

The technology behind cancer vaccines is the stimulation of the body’s defence mechanism “the immune system” to identify cancer cells and release antibodies and/or killer T-cells to destroy the occult or residual cancer cells.

In melanoma, there are recognised antigens like Mark-1, GP 100, TRIP1, and TRIP2. Scientists have isolated and made recombinant protein from these antigens and injected them back into the body. This activates the human immune system in the context of vaccination. The effort is to break the tolerance the body has towards these antigens and mount an immune response to it. In another approach, the therapeutic vaccine consists of (lysed) broken melanoma cell lines combined with adjuvant, which when injected back into the body activates the immune response to the tumour cells. Other companies are trying to develop cancer vaccines by taking the approach of injecting a plasmid that encodes a protein instead of the actual protein, which triggers an immune response to cancer cells.

To break the tolerance to antigens in the clinical setting, scientists require a better understanding of the immune system and the adjuvants to come up with a reliable process. Thus far, nobody has been very successful.

Products in the Pipeline

The companies that are likely to introduce cancer vaccines in the near future are Antigenics, Dendreon, Genzyme Molecular Oncology, and VaxGen. There is a strong possibility for some of these companies to successfully obtain FDA approval for products by 2005-2006. The most probable vaccines are for melanoma and prostate cancers. There are almost seven cancer vaccines that are in phase-III trials for 10 different cancer indications. The most advanced cancer vaccine is from Corixa called “Melacine” for melanoma, which has already received marketing approval in Canada. Melacine is expected to receive the FDA approval in the U.S. by 2004.

Comparison with Other Key Technologies

Monoclonal antibodies have established their efficacy and safety profile in treating cancer. The next generation of monoclonal antibodies has also evolved with the radiolabelling of monoclonal antibodies with radioactive agents. This forms a potent combination of targeted attack on the cancer cells.

On the other hand monoclonal antibodies have also started receiving approvals for multiple indications while vaccines are targeted at specific tumors and would be more narrowly focused. This limits the market opportunity for vaccines. Yet another technology which could become a potential competitor to vaccines is gene therapy. Despite the promise this technology holds, there are many hurdles that needs to be overcome before gene therapy products reach the market.

A trend similar to monoclonal antibodies can be seen with cancer vaccines. The success of the first cancer vaccine shall largely determine the fate of the future vaccines and the hopes of millions of cancer patients who long for a better quality of life.

Background

Frost & Sullivan, an international consultancy firm, has been supporting clients’ growth for over four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies include strategic consultancy, market intelligence and management training. Our mission is to work with our clients’ management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan’s network of more than 500 consultants, industry experts, corporate trainers and support staff, spans the globe with 19 offices worldwide.

Blood pressure measures the force that the blood applies to the walls of the arteries as it flows through them. It’s normal for blood pressure to increase when you exert yourself, or when you feel stressed or anxious. But if the blood pressure is consistently higher than normal at rest, this is high blood pressure, also known as hypertension.

Blood pressure and health

As blood is pumped around the body, it carries oxygen and nutrients that are essential for life. As a result of the pumping action of the heart and the size and flexibility of the arteries that carry blood, the blood is under pressure. This blood pressure is an essential and normal part of the way the body works.

When your nurse or doctor takes your blood pressure, the result is expressed as two numbers such as 120/80 (“one hundred and twenty over eighty”). The top figure – the systolic blood pressure – is a measure of the pressure when your heart muscle is contracted and pumping blood. The bottom figure – the diastolic blood pressure – is the pressure when the heart is relaxed and filling with blood.

A diagnosis of hypertension is made if you have a blood pressure of 160/90 or higher. If your blood pressure is close to this, your doctor will probably want to monitor it regularly. If you suffer from diabetes, it is even more important that your blood pressure is lower than this – ideally less than 130/80. For more details, see Blood pressure monitors, below.

People with hypertension have an increased risk of major illnesses including:

• cardiovascular disease including angina, heart attack and stroke
• kidney damage
• eye problems
• circulation problems in their legs, which could eventually lead to gangrene

However, the risk of cardiovascular disease is linked to other factors including whether or not you smoke, have diabetes or high cholesterol. Slightly raised blood pressure may not need to be treated so aggressively if other risk factors do not apply to you.

Hypertension is a big problem in the UK – about half of people aged between 65 and 74 are affected.

Types of hypertension

Types of hypertension Most people with high blood pressure - 95% - have what’s called primary or essential hypertension. This means that there’s no single clear cause of it.

Although it’s known that some factors to do with lifestyle can contribute to hypertension (see above), we don’t precisely In association with 40 ISSUE 1 2004 PHARMACEUTICAL FIELD understand why some people get it and others do not.

However, hypertension can run in families, and you are more likely to be affected if your close relatives are too.

But you are also more likely to develop hypertension if you:

• are obese (very overweight)
• drink a lot of alcohol
• eat a lot of salt
• are under a lot of stress

Secondary hypertension

You may be among the other 5% of people with high blood pressure who have what’s known as secondary hypertension. This means your condition can be linked to a recognised cause – in fact, it may be a symptom of another underlying disease.

Secondary hypertension can be caused by:

• kidney disease.
• adrenal gland disease.
• narrowing of the aorta

Secondary hypertension can also be caused by the contraceptive pill (rarely), or steroids, or by pregnancy causing pre-eclampsia.

Diagnosis

Most people with hypertension don’t have any symptoms. In fact, you may not even know you have a problem: most people are diagnosed when they have their blood pressure taken as part of a medical examination. That’s one good reason to have a regular check up with your doctor, especially if you’re over 65.

You may have heard that people with high blood pressure experience headaches and dizziness. However, in most cases, that’s not so. Only people with severe hypertension or a rapid rise in blood pressure are likely to experience warning headaches, blurred or impaired vision, fits or black-outs.

Before starting you on any course of treatment for hypertension, your doctor will give you a physical examination. You may be asked to come back for repeat measurements over a number of weeks to check that the high reading is an ongoing problem and not a one-off.

You may also need some tests, to see if hypertension is having an effect on the rest of your body. These may include:

• analysis of your urine (protein in your urine may be the first sign of a kidney problem)
• a blood test, to check the condition and working of your kidneys
• a chest X-ray, to identify any enlargement of the heart muscle
• an ECG (electrocardiogram), to look for any heart strain
• eye checks

Treatment

If you have very severe hypertension, you may need to be admitted to hospital for initial treatment. But it’s much more likely that your will be cared for by your GP and/or a nurse specialist, or the practice nurse, based at the surgery.

Lifestyle changes

First, your doctor or nurse is likely to discuss lifestyle changes which might help. He or she might, for example, advise you to:

• start to lose any excess weight
• get some regular moderate exercise
• cut down on salt and alcohol
• stop smoking
• have stress management or relaxation therapy

Medicines

If your blood pressure remains high, one or more of the following antihypertensive drugs may be prescribed for you.

• Diuretics, which increase the amount of salt and water removed from your blood by your kidneys, and widen your arteries. Eg bendrofluazide
• Beta-blockers, which reduce the work your heart has to do, by reducing your pulse rate. Eg atenolol
• ACE inhibitors or angiotensin 2 receptor antagonists, which block enzymes that constrict the blood vessels. Eg captopril, losartan
• Calcium channel blockers or alpha blockers, which help widen your blood vessels. Eg nifedipine

The drugs you are prescribed will depend on a number of factors, including their side effects, your other risk factors for cardiovascular disease and if you have any other illnesses. For example, if you get asthma, beta-blockers may not be suitable for you.

It is important to understand the benefit of having hypertension under effective control. This is because there is a commitment involved in taking any necessary medication every day for a condition that may have no symptoms.

It may take time to find the best treatment for you, balancing the benefits against any side-effects.

Blood pressure monitors

You might consider getting a blood pressure monitor to use yourself at home – discuss this option with your doctor, who should be able to help you choose a suitable one. If you do decide to buy one, go for a model that takes a measurement from your upper arm rather than your wrist or finger. And look for evidence that it has been “clinically validated” - proven to consistently match the readings given by professional monitors.

The unit of measurement for blood pressure is millimetres of mercury – or mmHg (where Hg is the chemical symbol for mercury). This is because the traditional blood pressure monitor - known as a spyhgmomanometer – uses a column of mercury to measure pressure. The same units are used for electronic blood pressure monitors.