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In the news - January 2007

Way Ahead 2007;11(1):3,16
  1. DoH reminder of obligation to provide disease modifying drugs
  2. Scottish Medicines Consortium (SMC) denies Tysabri treatment to Scots with MS
  3. NICE launches shared learning database
  4. Sex hormone trial launched in US
  5. MBP8298 trial for SPMS
  6. PMC clinic ordered to stop stem cell treatments

1 DoH reminder of obligation to provide disease modifying drugs

On 16 November 2006, the Department of Health contacted Strategic Health Authorities in England to ensure that PCTs and Trusts continue to meet their obligation to provide the disease modifying drugs for MS to people who meet the prescription criteria. The purpose of the briefing note was to remind PCTs and Hospital Trusts that there is a statutory duty under directions made under the NHS Act 1977 to fund treatment for all eligible patients. The MS Trust have been aware of problems in accessing the drugs in several areas around the country and have been pressing the Department of Health to remind Trusts that providing the drugs to people who meet the prescription criteria is an obligation not an option. We welcome this reminder and trust that all eligible people will now have access to the appropriate medication.

Source: Department of Health

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2 Scottish Medicines Consortium (SMC) denies Tysabri treatment to Scots with MS

The MS Trust is dismayed by the SMC decision to deny this treatment. SMC decisions are based on cost-effectiveness, using the cost per quality adjusted life year (QALY), a health economic formula which tries to determine the value of a treatment to a person's life, not the actual cost of providing the drug. Chris Jones said: "We share the sadness of Scots with MS at this decision. Clinicians will be prevented from prescribing an effective licensed treatment to people in need. QALYs mean nothing to people with MS, their families and friends. We trust that NICE, on behalf of people with MS in England and Wales, will not to be so short sighted when it makes a decision on Tysabri in mid-2007."

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3 NICE launches shared learning database

The National Institute for Health and Clinical excellence has announced it is to establish a new, searchable, shared learning database. The organisation is now looking for case studies from NHS organisations that fall into the following two categories:

  • general examples from practice that relate to 'How to put NICE guidance into practice';
  • examples specific to NICE guidance topics.

Nicola Bent, associate director at NICE Implementation Systems, hopes that this resource will allow both positive and negative learning experiences to be shared. The collections will be updated monthly, with examples having a two-year life span.

Source: E-Health Insider

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4 Sex hormone trial launched in US

The first large-scale trial of a sex hormone for treating women with MS has been launched in the US. The two-year, double-blind, placebo-controlled trial will investigate the use of estriol (in pill form) in combination with glatiramer acetate in 130 women with early relapsing/remitting MS. The effect on relapse rate and disability progression will be evaluated. Lead investigator Dr Rhonda Voskuhl hopes that by using estriol they will simulate some of the disease protection seen during pregnancy. If successful, it is hoped this trial will lead to a larger definitive trial that could lead to a new treatment option for women with MS.

Source: National MS Society

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5 MBP8298 trial for SPMS

A phase II/III trial of the synthetic peptide MBP8298 is currently recruiting in Canada and Europe, including six centres in the UK. The trial is expected to recruit up to 553 people with secondary progressive MS, who will be administered either MBP8298 or placebo intravenously every six months for a two-year period. MBP8298 consists of 17 amino acids linked in a sequence identical to a portion of human myelin basic protein (MBP).

Source: BioMS Medical

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6 PMC clinic ordered to stop stem cell treatments

In October 2006, the Dutch Healthcare Inspectorate ordered the PMC clinic in Rotterdam to stop performing stem cell treatments as they felt the clinic was unable to demonstrate the origin of the stem cells, their suitability for the intended application and the safety of the products being used. The original order was only for a period of one week, but this has been extended and the Dutch Ministry of Healthcare has issued a statement that the clinic is not allowed to perform any further stem cell treatments until they can prove to the Inspectorate, showing supportive documents, that the cells used are safe. The PMC website makes no mention of this ruling or the fact that they are not allowed to offer the treatment described on the site.

Source: Dutch Healthcare Inspectorate

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