Select Committee on Science and Technology Written Evidence


Memorandum by Roche Products Ltd

SUMMARY

  1.  Infectious diseases should be afforded a higher priority by the Government and the NHS.

  2.  Influenza is a prevalent, serious and highly contagious virus which can lead to lower respiratory tract complications and increased hospitalisation.

  3.  Although vaccines have a role to play in preventing influenza, many eligible individuals do not present for vaccination. Despite vaccinations some individuals may go on to develop influenza due to poor vaccine match against circulating strains. New antivirals, neuraminidase inhibitors, that can treat and prevent influenza may be used as an option for those individuals who are not vaccinated, or who get influenza despite having been vaccinated.

  4.  Hepatitis C is estimated to affect 10 times more people than have HIV. The virus is the leading cause of liver transplants worldwide and the cost of treating the disease will be enormous. Effective treatments are available that can cure the disease in over 60 per cent of patients.

  5.  The Government is not prepared for the scale of the problem ahead. More needs to be done to raise awareness of Hepatitis C among the public and health care professionals, to improve detection and make treatments available at the earliest opportunity.

ABOUT ROCHE

  Roche is a leading healthcare company with an expertise in infections through our influenza, Hepatitis C and HIV portfolios.

  Through its core businesses in pharmaceuticals and diagnostics, Roche takes an integrated approach to healthcare, with the aim of offering superior solutions that are tailored to the individual. In the UK, Roche employs nearly 2,500 people. We are committed to working in partnership with the Government, the NHS and other agencies to help enhance the health and quality of life of people in the UK.

  We welcome the Committee's enquiry into Fighting Infection and believe we have a valid contribution to make to the debate in this important area of healthcare.

  We are concerned that infectious diseases are not afforded a high enough priority by the Government, particularly due to the large number of other Government health priorities and targets, These concerns are especially relevant when considering the prevalence of Hepatitis C and the threat of the next influenza pandemic.

  Roche has recently launched a new treatment for Hepatitis C in the UK, a pegylated interferon known as Pegasys, and we are about to launch an innovative prophylaxis and treatment for influenza, a neuraminidase inhibitor (NAI) known as Tamiflu(tm). Additionally, we are a leader in the field of HIV/AIDS and have developed and manufactured a number of innovative treatments. We are planning to launch an innovative new treatment, a fusion inhibitor for treatment resistant HIV in 2003. As the Health Select Committee is currently undertaking an enquiry into sexual health, the focus of this submission is predominantly concerned with influenza and Hepatitis C.

THE COMMITTEE HAS ASKED FOR VIEWS IN PARTICULAR ON THE FOLLOWING QUESTIONS

What are the main problems facing the surveillance, treatment and prevention of human infectious disease in the UK?

Hepatitis

  More needs to be done to determine the epidemiology of Hepatitis C in the UK. Estimates for prevalence vary and the rates in sub-populations need to be established. The majority of the population infected with Hepatitis C are not aware they have the infection. Detection in at risk patients before the onset of advanced liver disease allows access to potentially curative medication.

Influenza

  Effective surveillance and communication of influenza activity is critical for proper awareness of, and preparation for, influenza outbreaks and accurate patient diagnosis. GPs would benefit from more timely local information on influenza. Accuracy of influenza diagnosis can be increased to 60 per cent when physicians know that influenza is circulating in the community and when they use a defined set of influenza symptoms as a diagnostic criteria.

Will these problems be adequately addressed by the Government's recent infectious disease strategy Getting Ahead of the Curve?

  Our view is that Getting Ahead of the Curve suggests what needs to be done, but does not give sufficient details or timelines. The key points are addressed in the strategy but not the mechanisms or targets for increasing awareness of HCV.

Is the UK benefiting from advances in surveillance and diagnostic technologies? If not, what are the obstacles to its doing so?

  The level of specificity, sensitivity and accuracy of current influenza point of care diagnostic tests may offer little incremental benefits over a clinical diagnosis of influenza when influenza is circulating in the community. Further development would be required to improve these parameters.

Should the UK make greater use of vaccines to combat infection and what problems exist for developing new, more effective or safer vaccines?

Hepatitis C

  Research is on-going to discover a target within the virus in order to develop a suitable vaccine. However, because of the genetic diversity of the virus no vaccine has yet been produced.

Influenza

  Clearly vaccines have an important role to play in preventing influenza but their efficacy is limited according to their match to the circulating virus. Due to the constantly changing composition of the virus, the vaccine must be modified each year to match the current strain. The efficacy of the vaccine is reduced if it does not contain the strain in circulation. Additionally, many people are still not vaccinated.

  While vaccination will remain the first line of defence against influenza, there is a need for new, effective therapies to prevent and treat influenza. New antiviral medicines represent a breakthrough in the management and treatment of influenza. They target the root cause of the illness by inhibiting the neuraminidase enzyme thereby preventing the virus from multiplying and spreading to new cells in the body. NAIs are effective against all influenza strains including potential pandemic strains. They reduce the duration of the illness, provide rapid relief from and reduce the severity and duration of symptoms.

  Tamiflutm also has a role to play in the treatment of influenza by reducing the incidence of lower respiratory tract complications and hospitalisation compared to standard therapy. Tamiflu can be used for prevention of influenza in certain situations, including the family setting, in closed communities and in nursing home residents. Tamiflutm provides immediate protection against influenza whereas vaccination may take up to two weeks to have an effect.

  It is established opinion among leading virologists that antivirals as well as vaccines will have a crucial role to play in managing the next pandemic.

Which infectious diseases pose the biggest threats in the foreseeable future?

Hepatitis C

  It has been estimated that there are approximately 250,000 people carrying the Hepatitis C virus in England and Wales (NICE), most of whom are unaware of their infection. This is over 10 times the number of people living with HIV.

  It is transmitted in a number of ways including shared needles by drug addicts (the main cause of transmission), tattoos, piercing and shared toothbrushes. Transmission through infected blood products occurred prior to screening in 1992, particularly affecting haemophiliacs.

  Symptoms may take up to 20 years to manifest. There is no effective investigation into the scale of the UK epidemic and the Government and NHS are not prepared for the scale of the problem ahead. About 85 per cent of people initially infected with Hepatitis C become chronically infected—ie the infection is not cleared by the body within six months. Many of these people do not have symptoms and will lead relatively normal lives for many years before realising the extent of the problem. The disease progresses over a period of 10-40 years, with some individuals sustaining liver damage that will lead to cirrhosis and potentially liver failure requiring liver transplant (at some considerable cost to the NHS). Cirrhosis may also progress to liver cancer which is one of the most common primary malignancies. If treatable, this would require surgery or transplantation. The virus is the leading cause of liver transplants worldwide.

Influenza

  Influenza is a prevalent, serious and highly contagious virus with potentially life-threatening complications including bronchitis and pneumonia. Often confused with the common cold, it is more severe and has different symptoms.

  Every year 10 per cent of adults and one in three children are affected by influenza. For most people, it is an unpleasant but by self-limiting illness. For the young, elderly, and those with heart disease, chronic respiratory problems, diabetes, kidney disease or the immunocompromised, infection with the virus can lead to a high risk of complications, hospitalisation and sometimes death.

  The consequences of influenza are underestimated. It has high medical and resource costs. During an epidemic, primary care consultations increase by 150 to 450 per cent and the rate of hospital admissions may increase by 70 per cent. 60 to 70 per cent of all influenza consultations are associated with a prescription and about 45 per cent of these are for an antibiotic which has no effect on the virus. Influenza accounts for 10 per cent of all sickness absences from work, is estimated to cost British business up to £6.75 billion per year in lost productivity and to lead to 3-4,000 deaths each year.

  A report published last November, Influenza: A race against time, examined the worldwide impact of influenza and its burden on society. It highlighted the importance of pandemic preparedness to counteract the disaster that the next influenza pandemic could bring.

  Three major influenza pandemics have crippled the world in the twentieth century and experts agree that the next one is imminent. The WHO has been urging national governments to plan for its arrival.

What policy interventions would have the greatest impact on preventing outbreaks of and damage caused by infectious disease in the UK?

Hepatitis

  Hepatitis C has received too little attention from policy makers to date despite the disease's prevalence. At last the Government has published a strategy for consultation to which Roche will be making a response. There is an urgent need to raise public and professional awareness and improve the general understanding of the prevalence of Hepatitis C and its treatment options through health promotion campaigns.

  Due to the silent nature of Hepatitis C, more needs to be done to improve detection and promote testing of the disease, particularly for those at risk now and in the past so that treatment can be made available at the earliest opportunity.

  The time delay between infection with Hepatitis C and onset of symptoms means that the disease is likely to slip down the list of treatment priorities among budget holders who are focused on the "now". A large number of patients will have been infected in the 60's and 70's and the numbers of these patients with end stage liver disease will be increasing. The longer-term implications of this include the costs of treating liver cancer and/or liver transplants along with the considerable suffering of the growing number of patients exposed to this disease. We believe that early diagnosis and treatment should be a priority and the Government should undertake a cost/benefit analysis of the long-term cost implications of not targeting the disease in its early stages. Roche has developed a cost effectiveness model for Hepatitis C which we would be happy to share with any interested parties.

  Early access to, and widespread availability of, new innovative treatments is also required, including pegylated interferon in combination with ribavirin to treat patients with Hepatitis C.

  There are currently very few services in place for Hepatitis C and resources should be set aside, or targeted towards setting up relevant infrastructure including specialist treatment centres. This is an important lesson from HIV and should be applied to Hepatitis C.

  We are also concerned that PCTs are not able to recruit the appropriate expertise to satisfactorily resource their Hepatitis C commissioning. It is important that the PCTs fully understand the long-term implications of the disease and put in place appropriate measures.

  NICE is due to appraise pegylated interferons as part of its seventh wave in 2003. Enormous geographic variations currently exist in access to, and availability of, treatment for Hepatitis C. Widespread implementation of NICE guidance with adequate resources will be important in the effective management of the disease.

Influenza

  The Infectious Diseases Strategy recognises the threat of the next severe pandemic and an influenza pandemic plan exists in the UK. It is important that the Government acknowledges the seriousness of influenza and is adequately prepared to manage not just a future pandemic but annual epidemics as well.

  There should be widespread access to vaccines, neuraminidase inhibitors and other antivirals which all have an important role to play in the management of influenza.

  An European Commission event on pandemic threats held last year recognised the need for better Europe-wide co-ordination to meet pandemic challenges and the inclusion of vaccines and antivirals in pandemic planning. The role of antivirals should be recognised in the Government's infectious diseases strategy.

October 2002


 
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