NICE
NICE has published draft guideline on the management of early and locally advanced breast cancer. The recommendations include starting adjuvant chemotherapy or radiotherapy no later than 6 weeks after surgery; prescribing an aromatase inhibitor to postmenopausal women with oestrogen receptor positive early breast cancer; and offering patients with early invasive breast cancer a baseline dual energy x-ray absorptiometry (DEXA) assessment of bone mineral density when starting adjuvant aromatase inhibitor treatment. The consultation period closes 8 October 2008.
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The Institute is also consulting on a draft guide outlining the processes used to develop its Interventional Procedures (IP) programme guidance . The guide aims to make the relationship between IP and other NICE guidance much more explicit and substantially updates the appeals process. It includes new processes for making use of commentary from patients and reviewing published guidance, as well as a new section on holding committee meetings in public. The consultation period close 10 September 2008.
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EMEA
At the end of July 2008, the agency received two reports of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis who had been treated with Tysabri for more than 12 months. The risk is already known, but the agency is assessing all the available data, before deciding whether any changes should be made to the product information or that provided for doctors.
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The agency has issued guidance on the viral safety of biotechnological medicinal products used in clinical trials . This includes: the criteria for, and the extent of, viral safety evaluation studies, that are required before and during clinical development; the extent to which manufacturers are able to refer to in-house experience concerning virus safety evaluation; required risk assessment.
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MHRA
The MHRA has issued an alert for the Sonesta 6210 fluoroscopy procedure table manufactured by Stille. It follows a report of uncontrolled movement of the device, caused by a short circuit in the handset. The device has a battery backup, and movement cannot be stopped by disconnecting the device from the mains. Patients are at risk of serious injury if this failure occurs during examination. Healthcare professionals are advised to contact the manufacturer: Tel: +46 8 588 58 029 or email: cecilia.osterkvist@stille.se
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COCHRANE LIBRARY
Several reviews have been published (Cochrane Database of Systematic Reviews 2008, Issue 3 ) , including the use of vitamin B for peripheral neuropathy. This concluded that e the evidence is insufficient to assess harm or benefit, only that vitamin B is generally well tolerated. But vitamin B was less effective than alpha-lipoic acid, cilostazol or cytidine triphosphate in the short term improvement of clinical and nerve conduction study outcomes, it found.
Similarly,there is not enough hard evidence or sufficiently well designed randomised controlled trials to draw conclusions about whether probiotics induce remission in Crohn’s disease, states a further review. Further research is needed, say the authors, because probiotics are popular with patients, and there is some evidence to suggest that they do have some impact on other gastrointestinal symptoms.
Risk assessment tools for the assessment of an individual’s risk of developing pressure ulcers are widely used, but the practice is not based on any evidence, as no randomised trials has compared their deployment with clinical judgement or no risk assessment, says a further review. This needs to be remedied to determine whether they do make any difference to the incidence of pressure sores, conclude the authors.
And finally, a systematic review of transcutaneous electric nerve stimulation (TENS) for cancer pain in adults found that only two randomised controlled trials met the inclusion criteria. One failed to show significant differences between TNS and placebo in women with chronic pain secondary to breast cancer treatment. The other study was underpowered, but did not reveal any difference between acupuncture-like TENS and sham acupuncture in palliative care patients. Large multicentre randomised controlled trials are needed, say the authors.
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DRUG AND THERAPEUTICS BULLETIN
Rituximab and abatacept for the treatment of unresponsive rheumatoid arthritis are more effective than placebo. But their use may be associated with unwanted side effects, such as serious infections, says the latest issue of DTB . Rituximab with methotrexate seems to be more cost effective than starting a second TNF inhibitor, and rituximab alone seems to be more effective in patients who are seropositive for rheumatoid factor. But abatacept has no proven advantage over rituximab, is more expensive, and has not been approved by NICE, says DTB. Vol 46 No 8 August 2008 www.dtb.bmj.com
DEPARTMENT OF HEALTH
The DH has launched a 10 week consultation on how the Care Quality Commission, which takes over responsibility for health and social care regulation from April 2009, will monitor compliance on healthcare associated infections. The new body will have additional powers of enforcement, including the ability to take prompt action where patients are at risk.
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