Mind welcomes NICE guidance but continues to express serious reservations over role of UK drug regulator
Posted Monday 6 December 2004
Statement from Mind's Chief Executive Richard Brook on today's announcement relating to the prescription of antidepressants, including the use of SSRIs.
Mind welcomes the well-balanced and well thought out NICE guidance on depression issued today. We were pleased to contribute to the development of these guidelines via members of the Mind network who sat on the working group that developed them. Mind believes they are a positive step forward for the millions of people that battle with depression in their lives. We strongly support their rapid adoption.
However, we believe the nature and style of today's announcement masks other unanswered questions. The UK government persistently states our drug regulatory system is the "best in the world". However, Mind has had serious concerns for some time relating to the work of the UK regulator; these have been heightened by my membership of and subsequent resignation from the SSRI expert working group. We still remain very concerned in a number of ways:
- How is it that the MHRA has set up and accepted a report from its expert working group to investigate SSRIs that has failed to consider, for most of the SSRIs, their raw clinical trial data. Rather it has based the vast majority of its work on summaries supplied by the manufacturers of the drugs. This is despite the fact it is publicly known that companies in paediatric clinical trials on SSRIs have concealed clinical data.
- How is it that a drug regulatory system that is "the best in the world" has allowed the prescriptions of antidepressants to rapidly rise in the last decade to 13 million a year, at significant cost to the UK taxpayer. What is the influence of the pharmaceutical companies in creating this situation through marketing, and how effectively have they been regulated and overseen?
- This increase in antidepressant use now looks very disturbing given the numerous well-publicised patient reports of side effects and withdrawal problems. This is especially so given that today's guidance indicates that many individuals should not have been given these drugs based on their clinical need. How has the regulator allowed this to occur despite several reviews of these drugs in the last decade?
- Why are there no announcements today indicating the need for urgent review of the regulatory process similar to the statements last week relating to the USA regulator, the Food and Drug Administration, also often stated to be "the best in the world"? It also is facing very similar criticism to the MHRA.
Besides the regulatory issues, there are also major resource issues relating to our health services:
- Why is there no government action being announced today to increase the interventions such as counselling, cognitive behaviour therapy or additional primary care resources to aid the 16 per cent of the population experiencing depression at any one time? In addition, there is an absence of any announcement relating to managing people's withdrawal from antidepressant; a known problem for many on antidepressant medication such as SSRIs. Depression wreaks havoc on individuals, their families and their carers. In order to tackle it effectively, resources need to be made available.
The decision to announce the MHRA expert working group's report in conjunction with the excellent NICE guidance potentially diverts attention from these major issues that relate to drug regulation and the level of mental health resources in the UK.
Mind believes that unless some of the above issues and their wider implications are urgently addressed by government, we will continue to have a drug regulatory service that can place individual's health at risk and that depression, one of the most common illnesses we experience today, will continue to fail to be resourced at a level that reflects people's health needs.
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