From the Department of Health, November 2007

From the Minister of State

Rt Hon Dawn Primarolo 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

22^nd November 2007

Dear Ms Woodcock,

Thank you for your letter of 17 October to Alan Johnson about Lyme disease.

I am sorry to read you are unhappy with Caroline Flint’s reply of 15 June (our ref: PO00000210663). I should explain that there is little further I can add to the Department’s replies of 15 June and 29 March (our ref: PO00000191336). However, it may be helpful if I restate some of the key points regarding the diagnosis and treatment of Lyme disease.

Firstly, testing for the immune response to an infection by B. burgdorferi sensu lato is the mainstay of diagnostic testing and provides the most reliable method of laboratory detection. This is done by detection of antibodies to B.burgdorferi sensu lato. This test can be insensitive in detecting infection in its very early stages, as the immune response may take some weeks to develop. However, it is very accurate in detecting late stage infection and the majority of patients with established later stage infection are seropositive.

Confirmatory testing in the UK is a two stage process, as recommended by the internationally recognised criteria for the diagnosis of Lyme borreliosis. There needs to be stringent interpretation of serological tests for specific antibodies to B. burgdorferi sensu lato and this is a task for expert microbiologists. The criteria recommended in the USA (from the Center for Disease Control and the Center for Prevention), Europe and the UK are as follows:

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

a sensitive screening test (for example, 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 only be used 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.

These are the serological criteria used in the laboratory diagnosis of Lyme borreliosis by the Health Protection Agency (HPA) Lyme Borreliosis Specialist Diagnostic Service at the HPA South-East Regional Laboratory, Southampton.

The patient’s history and risk of exposure to ticks is part of the diagnosis and if a person had developed infection after travel abroad, the testing would take account of any of the B. burgdorferi species that could be circulating in the areas visited, in addition to those that occur in the UK. As previously stated, patients who exhibit the characteristic erythema migrans rash can be diagnosed without the need for a laboratory test in support of the clinical diagnosis.

Therefore, a patient who has suffered serious symptoms that resemble those of Lyme disease over an extended period but who has a negative serology result when tested through the HPA’s Lyme disease Reference Laboratory is unlikely to have Lyme disease.

With regard to treatment, patients with early Lyme disease respond well to treatment with doxycycline or amoxicillin. Cefuroxime axetil is an effective oral alternative. Parenteral treatment is generally recommended for patients with neurological complications. Ceftriaxone is the most commonly used parenteral agent, because of its one-daily dosing regimen. Treatment duration is of moderate length, between 14 and 30 days depending on the stage and severity of the disease. There is currently no scientific evidence to support longer term therapy in the absence of objective evidence for continuing active infection. The outcome for most appropriately treated patients is excellent, but patients with longstanding infection and significant tissue damage may be slow to respond and their recovery may be incomplete, depending on the severity of their illness before treatment.

The HPA provides clinical and diagnostic advice to clinicians. This will usually be given directly to the clinician but may also include written advice and guidance, and referral to other specialists through the attending or treating clinician.

With regard to tick populations, the risk of infection varies across the UK as not all tick populations are infected with B.burgdorferi and not all ticks that are infected transmit the infection when biting. The risk to the public depends upon awareness of the risk and the precautions taken to prevent infection. In many of the areas with the greatest risk of infection due to significant tick host species, major public awareness campaigns are in place to advise the public of the dangers posed and how to avoid tick bites.

Finally, I note that you included with your letter of 10 May the ILADS position paper, Evaluation of antibiotic treatment in patients with persistent symptoms of Lyme disease. As you may be aware, much of the ILADS information in relation to Lyme borreliosis has been shown in peer-reviewed publications to be inaccurate and potentially harmful.

I hope this reply clarifies the Government’s position on this matter.

Yours sincerely

Dawn Primarolo