Mind believes drug regulation in the UK is flawed

Posted Tuesday 9 December 2003

Another four antidepressant drugs (SSRIs) have today been removed as treatment options for children and adolescents with depression as their risks outweigh their balances.

The MHRA (Medicines and Healthcare products Regulatory Agency) today advised doctors that the drugs Sertraline, Citalopram Escitalopram and Fluvoxamine do nothing to help children with depression and that taking them can lead to harmful side effects including a risk of suicidal thoughts and self-harm. Most of these drugs are not licensed for use but it is estimated up to 50,000 children are using them.

Earlier this year two other antidepressant drugs, Seroxat (paroxetine) and Efexor (venlafaxine) were contra-indicated for under 18s by the MHRA for the same reasons.

Mind, the leading mental health charity, welcomes the announcement but at the same time believes this is another significant piece of evidence demonstrating that the regulatory framework and processes used in the United Kingdom by the MHRA to regulate the drugs industry are flawed and do not put consumers' interests first.

Mind Chief Executive Richard Brook said: "It is totally unacceptable that for a significant period 50,000 children and adolescents in the UK have been prescribed antidepressant drugs that were not licensed for use but it is only now being demonstrated that they do not help and can indeed cause harm.

"The loud voices of users and a high profile campaign started a course of events that led  to today's announcement. Long-term, effective and strong regulation has not been in evident in this case or provided the type of information consumers have the right to expect."

The NHS "Choices" programme "Building on the best", announced yesterday, sets out the government's aspirations for a better understanding and use of medication. Mind believes that if consumers are to have any confidence in this programme the government must instigate a full and independent review with significant consumer involvement of this flawed regulatory process without delay. To fail to do so is to fail anyone who at some time needs to use medicines and will not be building on the best.

Richard Brook went on to comment: "There are enormous commercial interests trying to influence decisions about the use of drugs. Pharmaceutical companies represent the second largest industry in the UK. The public needs to have confidence that their health is being properly protected - particularly where children are concerned - and I do not believe we have a process in place at present that ensures this is happening."

Mind is also dissatisfied with the time it has taken the MHRA expert working group - set up explicitly to investigate the effects of SSRIs -  to reach its conclusions. Richard Brook says: "While the outstanding work required needs to be thorough, it has taken over nine months to complete the review of these drugs just for under 18-year olds. With a total of 13 million SSRI prescriptions in the UK a year - there is now a very urgent need to complete the investigation in terms of their effects on adults."

As a result of today's announcement, Mind remains seriously concerned that there is a lack of alternative non-drug treatments for children and young people with depression. For example, there is a shortage of professionals trained both in cognitive behavioural therapy and other non-drug approaches that are known to help in depression.

This lack of choice has often been the reason why doctors resort to prescribing antidepressant medication to young people. It is disappointing today that there has been no corresponding announcement about how the government will respond to the needs of the many young people who fight depression and now need other options in the light of this safety announcement.

Mind advises that young people who are on any of the drugs named above that they drugs should under no circumstances stop taking them suddenly, but should consult their doctor on what is best for them. More information on SSRIs, including withdrawal, is available on Mind's website. 

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*A drug is contra-indicated i.e. recommended not to be normally used, when the risks are known to outweigh the benefits to a specific group of people. This is also sometimes described as the risk/benefit being unfavourable.

**All the above drugs belong to a class of drugs known as SSRIs (selective serotonin reuptake inhibitors) of which Prozac is one. None of these drugs is licensed for children. However until now doctors have been entitled to prescribe drugs "off label" - outside the licence terms. 

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