Seroxat - The MHRA & GlaxoSmithKline

What Richard Brook said back in 2004

'Upset and angry' at lack of action
by Richard Brook Chief Executive, Mind

The so-called recent independent enquiries into the safety of SSRI's, a type of antidepressant - which include Seroxat - have been beset by scandal and failure.

These drugs have been reviewed by the UK government regulator five times over the last decade yet the most recent review has highlighted some disturbing facts.

First, in March 2003, the Medicines Control Agency (MCA) expert group had to be reconvened after it was revealed that two members of the group held shares in GlaxoSmithKline, the manufacturer of Seroxat, one of the very drugs they were supposed to be investigating.

Secondly, in June 2003, I was quite horrified when GlaxoSmithKline handed the Medicines and Healthcare Products Regulatory Agency (which replaced the MCA) evidence demonstrating that Seroxat can cause some young people under 18 to become suicidal.

Public safety

Yet, this evidence came from studies predominantly carried out in the late 1990s and the last one completed by early 2001.

Thirdly, in March this year, I learnt that the agency had possessed information for more than 10 years about significant withdrawal effects if Seroxat was taken in doses of more than 20mg.

This had been included in the original data submitted by GlaxoSmithKline from which the licence for Seroxat had been first awarded a decade previously.

Around 17,000 people were taking a dose of more than 20mg, but the MHRA had failed to take action before this.

I was, at this time, serving on the MHRA's expert group examining the safety of SSRIs, and felt no option but to resign.

The MHRA had tried to pressurise me not to publicly reveal that it was, in my view, effectively ignoring data from 10 years ago. I was not prepared to go along with such secrecy over what is a matter of public safety.

Side effects

" I said at the time of my resignation that the MHRA was either guilty of extreme negligence or worse dishonesty, and I stand by that now "
Richard Brook

The agency then accused me of causing unnecessary alarm by revealing the truth. Either the agency didn't understand the full implications of the medical data or, worse, that the data was fully understood and they failed to act.

Whatever way you look at it, by enclosing itself in secrecy the MHRA was failing its duty to the public. This is unforgivable.

Despite the previous four major regulatory reviews during the ten years and considerable consumer concern in the media, the public has never heard the truth about Seroxat - something that is the responsibility of the MHRA.

I said at the time of my resignation that the MHRA was either guilty of extreme negligence or worse dishonesty, and I stand by that now.

It was only this week a woman told me how her 18-year-old daughter committed suicide shortly after starting to take Seroxat again and days before it was banned for children and young people.

If that ban had been in place earlier it would have meant that she wouldn't have used it during the last two years of her life.

Scandal

This mother was convinced that if she and her daughter had known about the risks of Seroxat she would not have taken it.

She will always be haunted by wondering whether her daughter would be alive today if she had not taken a drug which, we were all told, had no dangerous side effects.

My job at Mind is to try and act on behalf of mental health service users. The MHRA should, at the end of the day, be doing the same for all patients.

There should be a public enquiry into drug regulation. If the sorry story of Seroxat is not convincing enough, look at past events.

Remember the scandal in the Eighties of the benzodiazepine drugs, such as Valium, when tens of thousands of people told of their horrors of addiction?

People who took benzodiazepines complained - and still do - of blackouts, epileptic seizures, memory loss, brain damage, insomnia and personality change. At first the drug regulators did not accept benzodiazepine addiction, or "dependence".

Too late

" It makes me upset and angry that no real action is as yet resulting from this tragedy unfolding before our eyes "
Richard Brook

It was only when, once again, Mind teamed up with another TV programme, "That's Life", to survey evidence from thousands of benzodiazepine users that the regulators were forced to face up to the scourge of addiction.

Subsequently, in 1988, the Committee of Safety of Medicines advised for benzodiazepines not to be prescribed for more than four weeks. Too late, I'm afraid, for thousands of people up and down the country.

We must urgently establish an independent drug regulatory agency which is supported with adequate government funding and operates independently from the drug industries' influence.

This is even more vital considering that more than 90 per cent of published research into antidepressants is funded by pharmaceutical firms. Yet, their raw data is often hidden away, unavailable to scrutiny from independent researchers.

At the moment, the MHRA receives its entire funds from drug firm licence fees, and some of the professionals sitting on key MHRA committees own shares in or work in institutions that receive research grants from pharmaceutical firms.

Having shares does not prohibit you from serving with the MHRA. It just means you must not give your opinion on the particular drug whose manufacturer you own shares.

Upset and angry

This arrangement is simply not robust enough to give us confidence that undue influence does not occur.

The MHRA also only takes seriously clinical trials and clinical data and, in reality, ignores the experiences of people actually using the drugs they regulate.

Shocking testimony of those who say their lives have been ruined by horrendous side effects of Seroxat is abundant, and much of it has been recorded on side-effect reporting cards - called "Yellow Cards - submitted to the agency. In light of the lack of influence they have had, these Yellow Cards might as well have been thrown in the bin.

It makes me upset and angry that no real action is as yet resulting from this tragedy unfolding before our eyes. I am not against the prescribing of any medicines including anti-depressants that are beneficial and work for individuals.

But I am against inappropriate and dangerous prescribing brought about by the failure to license medicines adequately.

Related to this story:
Taken on trust (21 Sep 04 Panorama )
Medicines regulator 'under fire' (02 Oct 04 Health )
Q&A: Medicines regulation (03 Oct 04 Panorama )
Panorama's two year journey (03 Oct 04 Panorama )
Information and helplines (01 Oct 04 Panorama )
Self harm and stress groups (01 Oct 04 Panorama )
Useful websites (03 Oct 04 Panorama )
Seroxat and Panorama: Timeline (03 Oct 04 Panorama )
Why we needed to regulate (03 Oct 04 Panorama )
Seven years of struggle (03 Oct 04 Panorama )
Seroxat: The viewers stories (03 Oct 04 Panorama )
Your comments (01 Oct 04 Panorama )

RELATED INTERNET LINKS:
Panorama: The Secrets of SeroxatPanorama: E-mails from the edge


Concerned?
Angry?

Then write to the Chief Executive of the MHRA, Kent Woods, here:

Professor Kent Woods
Chief Executive
Post-Licensing Division
Medicines and Healthcare Products Regulatory Agency
Market Towers
1 Nine Elms Lane
LondonSW8 5NQ

Or you could email him here: kent.woods@mhra.gsi.gov.uk

If he chooses not to answer then you can email the MHRA and ask them to forward your concerns on to Kent Woods. Email them here: info@mhra.gsi.gov.uk