This is another little exchange from a colleague’s archives – it dates from October 2004.
The article below is on the British Medical Journal’s (BMJ) website.
PERSONAL VIEW (BMJ)
When TV damned the drug regulators
On Sunday 3 October the BBC screened its third Panorama documentary about the antidepressant paroxetine (Seroxat). This was strongly critical of the work of the British regulatory body responsible for medicines, the Medicines and Healthcare products Regulatory Agency (MHRA). A multitude of plausible sounding experts and commentators had been assembled to impart some clear messages—there are big problems with paroxetine and the regulators have messed up big time. The programme claimed that the MHRA had overlooked vital information about paroxetine that suggested it could increase suicidal feelings in all age groups. Richard Brook, the chief executive of the charity MIND, stated on the Panorama website that the agency was “either guilty of extreme negligence or worse dishonesty” (http://news.bbc.co.uk/1/hi/programmes/panorama/default.stm). That is a serious accusation and, if the thrust of this programme is correct, we should all be worried about the medicines we prescribe, recommend, or take.
To be told on television that I and many colleagues do not care is galling. I have some limited insight into the making of this programme. I met with the producers informally and then sat in front of their cameras for about 90 minutes answering questions on a wide range of issues. They approached me because I worked at the Medicines Control Agency (as it then was) from 1990 to 2002 and because they had not yet managed to interview anyone from the MHRA. They said they wanted to hear the “other side.”
I tried to explain some of the difficulties involved in deciding cause and effect, particularly when the putative effect (“suicidality”) is a consequence of the illness for which the drug is prescribed. I also explained in detail the process of post-marketing surveillance, its strengths and limitations, and some relevant initiatives. I indicated that my view was that there were no grounds for secrecy in relation to data on drug safety and said that major change was taking place in this respect (the UK secrecy law relating to medicines is being repealed from 1 January 2005). I showed them a report produced in 2003 by the National Audit Office (NAO), which was generally favourable to the MHRA but made some constructive criticisms. The NAO is not known for pulling its punches when it comes to criticising government bodies. I endeavoured to convey some balanced messages:
* there are some problems with paroxetine, the jury is out, and the issues are being, and have been, taken seriously
* the surveillance system is not perfect but people are trying to improve it
* the regulatory system is not perfect either but the people working within it do their best to balance risks and benefits and are solely driven by public health and patient considerations
* there is a need to consider what other bodies are doing internationally (less and more slowly than the MRHA).
It is now clear that the producers did not accept the first three messages and they completely ignored the fourth. Although the producers were courteous and friendly, it seems as if they set out to damn the regulators.
The interview with Panorama was not a pleasant experience. Reporter Shelley Jofre’s harassing tone should not have come as a shock (but it did) and she rapidly strayed beyond the agreed boundaries of what I felt able to cover. Just over a week before the programme I received a call from the producer—they had succeeded in interviewing the MHRA’s chairman, Sir Alasdair Breckenridge, and therefore had cut me and five others out of the programme. Rather selfishly, I was delighted—who really wants to appear on Panorama?
In the end I was staggered by how one sided the programme was and disappointed that I had effectively wasted my time with the programme makers. Their almost total reliance on temporal association as the sole criterion for causality was striking. Difficult and debatable issues were presented as facts and several participants must have been a “dream” for the programme makers. Periodically saying that “Seroxat has helped millions” and “do not stop your treatment” did not offset the hugely biased approach. I wonder how many patients would inappropriately stop treatment and how many unnecessary consultations there would be in the coming weeks.
Regulators must expect criticism—it goes with the job. They should defend themselves when experts or television producers tell them they have got it wrong. However, when such people claim, without presenting any evidence at all in support, that patients are their last priority, they have a right to be angry.
I last saw a patient about 16 years ago but I still care passionately about patient safety. To be told on national television that I and many colleagues do not care is galling beyond measure. Neither the drug nor the regulator is lilywhite but the reporting is surely the most dangerous offender here.
I read with interest your “Personal view” in the BMJ.
I see a table in front of me and so here are my cards. I have been taking Seroxat for 7 years. 30mg a day. For the last six months I have been trying to stop taking the drug. I am now down to 8mls of the liquid (16mg equivalent in tablet form). I can see how you might be “offended” by the messages of the programme. However, speaking from my point of view I don’t really care if you happen to be offended.
I have been seriously damaged by this drug and my family and I suffer every day at the moment as I try to reduce my dosage. A lot of real people have real problems with this drug – the evidence is clear. And yes – I feel do let down by the MHRA and GSK.
You will surely understand that Mr Breckenridge is the person who is best placed to balance matters (hence your own contribution ending up on the digital equivalent of the cutting room floor). You must surely agree that his performance was poor. He was evasive, weak and squirming.
Maybe you might have the better person after all, although I would take issue with your ‘balanced messages’.
…there are some problems with paroxetine, the jury is out, and the issues are being, and have been, taken seriously…
I have to say that this first statement sums up all that is wrong with the regulators/medical profession…. It’s glib, dismissive and shows no real understanding of the issue or concern for patients who are suffering.
…the surveillance system is not perfect but people are trying to improve it…
I should hope so – I think that the MHRA’s income is around £70 million a year – say things aren’t right but don’t worry we’re ‘trying’ to improve is not simply good enough. How much will it cost to get it right?
…the regulatory system is not perfect either but the people working within it do their best to balance risks and benefits and are solely driven by public health and patient considerations…
Well, their best is not good enough then. I understand a little of how the Pharmas work and I think this is part of a much wider discussion about truly new drug discovery, product pipelines, patents & patients, marketing spend and of course the all important PROFIT. The revolving door between the Pharmas and the MHRA needs to be locked shut.
…there is a need to consider what other bodies are doing internationally (less and more slowly than the MRHA)…
Ah ha – using a negative to prove a positive… flawed logic there, I’m afraid
Now – I put my cards on the table – can I see yours please? What’s your angle as they say?
Could I ask what links or connections of any kind you have with any drug companies now (or in the past)? I’m sorry if you think that’s a little personal, but I know PR and spin inside out and as such I tend to read between the lines and trust very little.
While on that matter I’d like to ask about this line in particular: …A multitude of plausible sounding experts and commentators had been assembled… Damning with faint praise indeed. That’s the classic Pharma line when confronted by experts who are ‘off message’ – and it seems somehow out of place with the rest of your article. I wonder why you felt the need to have a go at the people who were on the programme?
In fact, on reflection the introduction of your article could almost have written by a person other than yourself as it seems so different in style and language from the rest of your piece.
And what’s changed at the MHRA since 2004?