Back in October the British Medical Journal (BMJ) published new UK guidance from the Department of Health on the use of immunoglobulin in the management of various conditions, including ME/CFS: click to view
The MEA sent in a response to the BMJ (CLICK HERE – Oct 25 in the MEA archive).
The authors of the guidance have now replied to these criticisms on the BMJ website:
Prescribing intravenous immunoglobulin: summary of Department of Health guidelines
Department of Health immunoglobulin guidelines are evidence-based and provide a framework for all treatment decisions
23 December 2008
Drew Provan, Consultant Haematologist
Department of Haematology, Barts and the London NHS Trust, The Royal London
Hospital, London E1 2ES, Helen M Chapel, W A Carrock Sewell, and Denise O'Shaughnessy
We thank the ME/CFS associations for their interest in these Department of Health (DH) guidelines. Clearly, some form of treatment prioritisation had to be introduced to ensure that, for those considered the highest priority because of risk to life without treatment, immunoglobulin is available. It is not the intention to deny patients effective treatment, but rather to introduce a prioritisation that ensures availability of life-saving treatment for those groups of patients in whom benefit is proven.
The process by which treatment recommendations were made is set out in detail in the guidelines and was not related to NICE recommendations. In the case of ME/CFS, the decision to recommend against immunoglobulin was made by eminent neurologists, and was evidence-based. The principal study reviewed (a randomized, double-blind, placebo-controlled trial) showed no significant benefit of intravenous immunoglobulin ; the evidence provided by this study was not outweighed by the small case-report study cited by Tom Kindlon . The findings of the randomized study raise another important consideration before immunoglobulin is prescribed – the potential for adverse reactions. The use of immunoglobulin should be carefully considered because of potential and sometimes fatal individual risks associated with treatment with a blood product, such as transmitted infections.
Finally, it is important to understand that the guidelines and the demand management plan provide a framework for all treatment decisions. There is a process of ‘exceptionality' that offers the opportunity for treatment in cases that fall outside the broad definition of a disease state. In the case of parvovirus B19-associated CFS, the treating physician may request immunoglobulin treatment on the basis that parvovirus B19-associated CFS is different from the reference population of CFS patients. The physician would be expected to present evidence to the local immunoglobulin assessment panel that an individual patient is likely to gain significantly more benefit from the intervention than might be expected for the average patient with that condition. In such exceptional cases, health commissioners would be asked to sanction funding of the treatment following approval by the local panel. As for all cases of immunoglobulin treatment, the national immunoglobulin database entry must be fully completed, and this will become a requirement for funding in the near future.
1.Vollmer-Conna U, Hickie I, Hadzi-Pavlovic D, Tymms K, Wakefield D, Dwyer J, et al. Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome. Am J Med1997;103:38-43.
2.Kerr JR, Cunniffe VS, Kelleher P, Bernstein RM, Bruce IN. Successful intravenous immunoglobulin therapy in 3 cases of parvovirus B19- associated chronic fatigue syndrome. Clin Infect Dis2003;36:100-106.
Competing interests: All authors were members of the Department of Health's IVIg Expert Working Group: guideline development group (DP, DO'S), demand management plan group (HMC, DO'S), and database development group (WACS, DO'S).