Government response to Ten steps

From the Minister of State

Caroline Flint MP
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS

To Ms Stephanie Woodcock
Chair
Lyme Disease Action
53 Kernick Road
Penryn
Cornwall
TR10 8NS

29^th March 2007

Dear Ms Woodcock,

Thank you for your letter of 19 February to Patricia Hewitt about Lyme disease. I am replying as the Minister responsible for this policy area.

I have responded below to each of the Ten steps to better control of Lyme disease which you promote, and these responses also address issues raised in the main body of your letter. In each case, for clarity in such a long reply, I have first quoted each 'step' in italics.

Lyme Disease Action is calling upon the Government to take urgent steps to ensure that people who have Lyme disease are recognised and accorded their full human rights:

1. By ensuring that people with Lyme disease receive prompt, adequate and appropriate treatment that, in some cases, may be long-term.

People can be correctly diagnosed and given rapid treatment by being tested through the Health Protection Agency's (HPA's) Lyme Reference Laboratory. The use of these facilities is readily and freely available to GPs and the NHS. I understand that long-term treatment is rarely needed and long-term complications are rare.

2. By ensuring that more specialist clinicians trained in the clinical diagnosis, treatment and care of Lyme disease patients become available within the National Health Service.

Clinical diagnosis of Lyme disease is often done without the need for laboratory tests where people have an obvious tick bite resulting in the usual mild effects of a red raised rash in the vicinity of the bite.

Most effects of infection are mild and if the GP is confident of a positive diagnosis on the basis of obvious clinical signs then there is no obligation to submit for a laboratory confirmation.

There is clinical specialism within the NHS. As you will be aware, the HPA is working to increase awareness of Lyme disease and provides clinical advice to physicians who care for patients who may have Lyme disease. The Agency has nationwide links to experts in infectious diseases, neurology, rheumatology and other specialties who have a particular interest in Lyme disease, to whom patients can be referred. It takes part in national and international collaborations to improve diagnostic tests and to promote evidence based treatments.

The HPA has also raised awareness of Lyme disease through its website and through presentations to, and discussions with, professional and recreational and special interest groups. In addition, NHS Direct has published comprehensive information on the disease, including preventive measures, on its website.

3. By ensuring that clinical guidelines for diagnosis and treatment of patients are developed for all medical staff and ending over-reliance on current laboratory tests in diagnosis.

As I have explained above, the HPA is working to improve awareness of Lyme disease. Clinicians in the UK have ready access to the best diagnostic tests available for the disease and NHS diagnostic tests conform to internationally agreed criteria and the tests are freely available.

Laboratory confirmatory testing is essential to diagnose Lyme disease if the typical 'erythema migrans' (red rash) is either missed, or absent, or the person is not aware that they have been bitten by an infected tick. Ticks are usually encountered in areas where deer/sheep are present and if the person has been exposed to their environments.

4. By ensuring that every effort be made to gain a reliable laboratory test or set of tests for Lyme borreliosis (Lyme disease) and closely associated tick-borne diseases.

Reliable laboratory tests have already been developed and there is an accepted international testing protocol which is followed in the UK. However, some private laboratories do not follow this protocol and their tests should not be relied upon for diagnosis of Lyme disease.

The internationally agreed criteria are based upon stringent interpretation of serological tests for specific antibodies to Borrelia burgdorferi sensu lato and are accepted and applied by the NHS laboratories in the UK.

These serological criteria are used by the HPA Lyme Borreliosis Specialist Diagnostic Service at the HPA’s south east regional laboratory, Southampton. Details of the testing criteria are given in the attached annex.

Regrettably, there are a number of unorthodox tests that have been privately developed over the past few years and it is wrongly claimed that these tests can diagnose Lyme disease more accurately than conventional, internationally accepted laboratory criteria available on the NHS. The use of such tests for the diagnosis of Lyme disease can have serious implications for patients, both for those who genuinely have Lyme disease and require appropriate treatment, and for those who are led to believe that they have Lyme disease and go on to receive treatment that is inappropriate and may be potentially harmful.

The Chief Medical Officer remains concerned about the impact of unorthodox and unvalidated tests that can incorrectly give a diagnosis of Lyme disease and commissioned the Department’s Inspector of Microbiology to investigate the use of such unorthodox diagnostic methods in the UK. Examples of tests investigated by the Inspector of Microbiology are the fluorescent antibody test (Q-RIBb) test developed by the Bowen Institute in Florida and a fluorescent test and culture method developed by a Dr Mattman.

The Inspector of Microbiology concluded that the validation of the Q-RIBb test was not scientifically sound and had been shown to be invalid in peer-reviewed literature and the Mattman culture medium is discredited as it has been shown that this medium fails to grow B. burgdorferi, the causative organism of Lyme disease. Such tests should not be used for the diagnosis of Lyme disease.

The Bowen Institute was inspected by a team of Inspectors from the Florida Agency for Health Care Administration and the Centers for Disease Control and Prevention (CDC), Atlanta (Bacterial Zoonoses Branch, Division of Vector-Borne Infectious Diseases). The laboratory was denied licensure and is also not certified under the Clinical Laboratory Improvement Amendments. Such certification is required for all laboratories performing clinical laboratory testing. A warning was issued in CDC’s Morbidity and Mortality Weekly Report, 11 February 2005, advising caution regarding many commercially promoted tests for Lyme Borreliosis and restating the internationally accepted criteria for diagnosis. The CDC advises clinicians in the USA to use laboratory tests that are approved by the USA’s Food and Drug Administration or ones that have satisfactory performance characteristics. The Q-RIBb test does not meet these criteria.

5. By ending over-reliance on a tick bite risk assessment in the diagnostic procedures for Lyme disease.

Tick bite assessment is important in risk assessment as the disease can only be acquired through the bite of an infected tick.

Non-exposure to the environment where ticks are found is unlikely to give rise to Lyme disease. However, if there is any doubt, exposure to the causative organism of Lyme disease (Borrelia burgdorferi sensu lato) can be detected by laboratory tests long after the exposure, by detecting the specific antibody response to that causative organism.

Lyme Disease Action is calling upon the Government to take all possible measures to form an accurate assessment of the scale of the problem and to improve disease prevention measures:

6. By granting notifiable status to Lyme disease throughout the United Kingdom.

(and)

7. By ensuring that every effort be made to gain reliable case numbers of Lyme disease.

Although Lyme disease is not a notifiable disease, it is recognised as the most significant of our vector-borne diseases and is taken very seriously in the UK. Granting notifiable disease status to Lyme disease will not necessarily increase detection of the disease. Laboratory confirmed reports are already received by the HPA and this enables an estimate of the number of cases of the disease to be made. As most people suffer only mild symptoms and might miss or ignore the initial red rash and recover without recourse to their GP, making the disease notifiable would not detect these cases.

8. By further assessment of tick surveillance procedures and their relationship to case numbers.

It is already known that tick populations are linked to deer populations and that areas where the public has close access to areas grazed by deer are where people are at particular risk of being bitten by ticks. The public is warned in those areas of greatest risk to take steps to protect against tick bites.

9. By taking the lead in ensuring that full information on Lyme disease and its prevention is widely disseminated to all sectors of society.

Information about Lyme disease is readily available to the public on the HPA’s website. In areas, such as the New Forest, where the risk is greatest there is publicity about the risk to the public through posters and leaflets.

10. By urgently bringing about a programme of research into all aspects of Lyme disease and associated tick-borne diseases.

As much is already known about the diagnosis, treatment, and the mode of transmission of Lyme disease and other tick borne diseases, further research is not currently considered as a priority.

As I have stated, Lyme disease is already acknowledged as the most important vector borne disease in the UK, though its incidence is not high.

Finally, your letter does not make clear whether those people contacting your trustees have been tested by the NHS and received negative results for Lyme disease. The most appropriate course of action for anyone who is concerned that they may have the disease is to consult his or her GP about being tested for Lyme disease by the HPA’s Lyme Borreliosis Specialist Diagnostic Service.

It is important to stress that many of the syndromes currently attributed to Lyme disease are not, in fact, due to this infection. It is vital that, where there is concern, proper laboratory testing is undertaken using the Lyme Borreliosis Reference Laboratory, which has foremost expertise in the diagnosis and treatment of this disease and can advise clinicians throughout the UK and internationally.

I hope this reply is helpful.

Yours

Caroline Flint

Annex:

Testing Criteria for Lyme disease (Borrelia burgdorferi)

Serum samples for the detection of antibodies to B. burgdorferi should be analysed by a two-test procedure:

*a sensitive screening test (such as ELISA or IFA). All samples judged to be reactive or equivocal in the screening test should then be confirmed by;

*a Western blot for antibodies to specific B. burgdorferi antigens.

The Western blot should be used only in succession with an ELISA or IFA test. Detailed interpretive criteria for Western blots differ between Europe and the USA, to take into account differences in the geographic distribution of the infecting genospecies.

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