Charles Medawar - Social Audit, August 2003

The Medicines Control Agency (MCA) ceased to exist on April 1st 2003, though little changed when it was reconstituted as the Medicines and Healthcare Products Regulatory Agency. In the MHRA the regulation of drugs and medical devices are now under the same roof, but otherwise the change was mainly to do with public relations and presentation.

The appointment of Professor Alasdair Breckenridge as Chairman of the MHRA was a response to the MCA’s image problem and its dismal public profile (NAO, 2003). The photo of Breckenridge that tops the MHRA website home page may have been intended to counter this. Or perhaps it is just a filler, less to do with aesthetics and more to cover for the continuing failure to appoint a chief executive; the MCA/MHRA has now been rudderless for nearly a year.

Another part of the solution to the image crisis was the appointment of two press officers from the Department of Health, with special responsibilities for the pharmaceutical industry and drug regulation. Now, for the first time, the MHRA publishes its own press statements – though it posts them in a little corner of its website, tucked well away.

Two recent press statements – both to do with SSRI antidepressants - illustrate the deeper mess the MHRA is now heading for. In different ways, they illustrate news management policies that amount to digging when in a hole. The problem goes deeper than the texture of words, though some might cause even a seasoned drug rep to blush. For instance: "Notes for Editors: … these drugs (SSRIs) work by increasing the level of the chemical serotonin in the brain, which helps to alleviate the symptoms of depression."

At this point, I should declare some possible conflict of interest, as an ejectee from the June 18th press event where editors were so informed. This was the briefing that the DoH organised to contain the potentially explosive news that Seroxat should no longer be prescribed for children. The circumstances of the ejection (enforced non-admission to be precise) have been described elsewhere, in a revealing but fruitless correspondence with Mr Jon Hibbs, Deputy Head of the DoH press office.

Before he went to ground, Mr Hibbs was still insisting that the Department had done just the right thing – i.e. inviting only selected journalists, deliberately not inviting others (notably Panorama), and then refusing entry to the one scientific journalist who had been tracking this story for years. That, said Hibbs, was because he was not a ‘bona fide’ journalist with the appropriate ‘credentials.’

Six weeks after the event, Mr Hibbs has yet to detail what it takes to acquire the appropriate bona fides or credentials. The apparent inaccessibility or lack of any hard and fast criteria makes accreditation impossible. It also encourages the DoH to organise its press briefings at whim, along the lines of a crude punishment and reward system. It seems a perfect recipe for spin, sleaze and digging deeper still.

Now I have to admit another possible conflict of interest, involving a bad error of judgement. In 1997, I was too inclined to believe what the present Prime Minister promised by way of open and honest government. I’m sure he still believes it; I no longer can. Here is just a fragment from much more in the same vein:

"As I said information is power and any government's attitude about sharing information with the people actually says a great deal about how it views power itself and how it views the relationship between itself and the people who elected it.  I want to say two things about this, one of which is very obvious, and one of which is less obvious.

The crucial question is does the government regard people's involvement in politics as being restricted to periodic elections? Or, does it regard itself as in some sense in a genuine partnership with people?  And the government's attitude to what it is prepared to tell people and the knowledge it will share with them says a great deal about where it stands on that matter.

My argument is that if a government is genuine about wanting a partnership with the people who it is governing, then the act of government itself must be seen in some sense as a shared responsibility and the government has to empower the people and give them a say in how that politics is conducted"
(Blair, 1996).

Shortly after the 1997 general election, I wrote to Tony Blair - partly to congratulate, but also in commiseration. I advised that his government had inherited a nasty problem involving dependence on SSRI antidepressants. But the predictable happened - virtually nothing, for over five years. The problem got worse until, finally, came some credible promise of effective action: in May 2003 a working group was set up under the aegis of the Committee on Safety of Medicines (CSM). This came about after several ineffectual enquiries, and only after the almost farcical dissolution of an earlier "intensive review".

I am reluctant to take up this matter with the Parliamentary Ombudsman, since she is now reconsidering another complaint - also to do with my enforced exclusion from due process. In November 2002, the MCA debarred me from giving evidence to the "intensive review" of SSRIs, because I was "not a scientist". Alas, being neither a fully fledged journalist nor scientist, I seem to stall between two fools; my credentials as a research-based, scientific journalist were established in the Court of Appeal, long before Prozac was around.

If this is not one for the Ombudsman, perhaps it should go to Mr Blair. Surely he will endorse my application for credentials? Surely Number10 will get the political point that is lost on Mr Hibbs? The SSRI volcano is already rumbling and due to erupt around the New Year. The government is now on the brink of having to admit to a substantial drug disaster, partly of it's own making. The risks seemed obvious (Medawar, 1994), and Mr Blair was warned of them even if doctors and users weren't, and the regulatory response was inadequate and incompetent. The writing on the wall says the government is going to need all the public confidence it can get; the Department of Health's news management strategies do nothing to earn or inspire it.

Meantime, I should mention one other source of bias, for all I have done to try to contain it with carefully chosen words. Some of the best advice I ever had (Morton, 2002) was, to "never soften the outrage." I do not feel inclined to do so.

More to come
This story does not end there; in fact it only just begins. The SSRI affair raises basic questions about the whole approach to drug control, the status of patients and consumers, and regulatory conflicts of interest. One of the big questions on the agenda is about the value of reports of suspected adverse drug reactions by patients, compared with those sent to the regulators (on 'Yellow Cards') by health professionals.

On 21 July, the MHRA put out another press statement to selected journalists - this time hoping that coverage would be minimal and low. On behalf of the MHRA, the Department of Health announced a review of the Yellow Card scheme - the first of its kind in 40 years. It was a rushed decision that apparently by-passed the CSM (and Medicines Commission), the founders and co-sponsors of the scheme. Nor was the review even mentioned in the "What's New?" section on the MHRA website. The announcement was buried in a press statement, belatedly posted to the aforementioned corner of

News of the review stirred neither The Lancet nor the British Medical Journal enough to report it, so the DoH escaped questions about what prompted the review. The few papers and journals that carried the story hardly departed from the press release.

This does not bode well for the outcome of the Yellow Card review, especially in view of what prompted it. The story so far began late last year, soon after the Panorama programme, "Secrets of Seroxat" (October 2002). That broadcast led to a flood of emails from viewers, describing problems with dependence and withdrawal reactions, and thoughts and acts of violent and suicidal behaviour. These emails were analysed, and a paper (Medawar, Herxheimer et al, 2002) was later published, to coincide with Panorama's follow-up programme: "Seroxat - Emails from the Edge" (May, 2003).

Meanwhile, one of the principal authors of the analysis of the Panorama emails, Dr Andrew Herxheimer, had requested from the MCA, print-outs of the so-called, ASPPs - the 'anonymised single person prints' derived from Yellow Card reports. The batches Herxheimer requested were those reporting suspected withdrawal problems and suicidal behaviour linked with paroxetine - the idea partly being to compare the value of reports from users and professionals.

To its everlasting credit (and to Andrew's and my surprise), the MCA did produce much of the data requested, and he and I then set about an analysis of the ASPPs. The results will soon be published in the International Journal of Risk and Safety in Medicine, but we recently outlined the main findings in evidence to the CSM working group on the safety of SSRIs. Our evidence pointed to previously unrecognised risks with paroxetine and other SSRIs; it also suggested basic flaws in the Yellow Card scheme; it seemed to us "chaotic and misconceived".

Then, in June 2003, we asked the MHRA to provide ASPPs for all the other SSRI and related antidepressants, to check and extend the analyses done before. It seems to have been this request - and our appeal to the CSM working group to endorse it - that brought the shutters down. The MHRA announced its review of the Yellow Card scheme on the day before Herxheimer and I gave evidence to the CSM working group on SSRIs.

The Yellow Card review will be conducted by Dr. Jeremy Metters, former deputy Chief Medical Officer at the DoH, and he has been asked to report to Professor Breckenridge by the end of 2003. His tasks are:

To identify and describe the range of issues which should be considered when considering access to data generated by the Yellow Card scheme including ethical, operational, financial and statutory (including open Government/FOI).

To identify relevant stakeholders to the scheme and to define how such interests arise.

To consider in what circumstances access to the data generated by the scheme could be said to be in the public interest and the extent to which this falls within existing legal provisions.

To make proposals for guiding principles and a mechanism for handling such requests.

To make recommendations for action.

This review of the Yellow Card scheme could lead in one of two directions, or get stuck at several in between. At one extreme, Metters could recommend restrictions on access to anonymised Yellow Card data to prevent further analysis of precisely the kind that revealed the need for his review in the first place. The temptation will be great and, no doubt, there is industry pressure for it. The last thing the companies want is recognition that the foundations of the drug safety monitoring system show cracks and need reconstruction.

On the other hand, the Metters review provides an opportunity to recommend more openness – to the extent of putting all such anonymised ADR data on the Internet. Properly organised, this would encourage much better standards of reporting, and hugely improve communication of information about possible drug problems. Indeed, the emerging scandal and tragedy of the SSRIs would not have happened if the chapter and verse of professional experience with SSRIs had been up on the Internet – along with the countless reports from users, posted over the years.

It could go either way, but I’ll hazard an optimistic guess. Notwithstanding the deployment of the DoH/MHRA news management cavalry, the political fallout from the SSRI affair will make it almost impossible to put the lid on such an important source of drug safety information. This is an incentive for Dr Metters to recommend changes that would make the Yellow Card system truly the best in the world, and by far.

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