Dear Ms Neill,

Thank you for your letter of 22 February. I’m sorry if I didn’t make it clear in my letter of 1 February that I was not so much bringing a complaint about Dr Benbow, as enquiring about whether and how to do so in the unusual circumstances I outlined.

I mentioned that my search of the GMC website yielded no guidance, nor obviously applicable case law, but thank you for telling me that allegations of misconduct would almost certainly best fit. However, I have checked the GMC website again and have found no pithy judgments, definitions or precise guidance about what misconduct might entail. I would therefore welcome any advice you might give about what might be relevant and appropriate in pursuing the issues in this case.

It might help to clarify these matters at the outset, because preparation of the case would involve me in a lot of work – and a great deal more by the GMC, if the case were to be investigated and pursued. What was said in the broadcast interview would need to be tested against substantial, sometimes detailed evidence, to establish how true, fair and appropriate it actually was. You will appreciate this from the recordings and transcripts of the programme I shall send you, though the gist is clear.

Dr Benbow publicly and emphatically denied the existence of risks with Seroxat® when his employers were in possession of evidence that those risks were substantial and real. The book, Medicines out of Control? gives a summary of events and context, through December 2003, and I shall send you this too. Meanwhile, Panorama specified two main problems: 

1. Some users experienced severe and prolonged withdrawal symptoms and felt addicted to Seroxat®; they were unable to stop taking the drug when they very much wanted to. This problem was clearly significant: there were (and are) more such adverse drug reaction reports for Seroxat® than for any other drug. With apparent sincerity, but also quite deviously, Dr Benbow denied their significance. However, within three months of the second Panorama programme, GSK withdrew its claim that Seroxat was not addictive, and radically revised its previous insistence that withdrawal symptoms were rare and mild. They admitted (as they were required to do) that about one-quarter of all users would experience withdrawal reactions, some severely so.

2. Concern was expressed also about the risk of paroxetine-induced violence and self harm including suicidal behaviour, especially in children and adolescents. Again Dr. Benbow denied the available evidence, though a few weeks after the second Panorama programme, the UK regulators required Seroxat® to be contraindicated for use by under 18-year olds. Having seen the relevant data, it took them just two weeks to do so. Independent reanalysis of the original data in 2006 showed the risk for children to be greater still, and that a significant risk existed for adults too.

In my earlier letter, I alluded to the apparent complexity of the issues, but perhaps too obliquely. The prospective complaint is not primarily about Dr Benbow’s abilities as a clinician, the traditional concern of the GMC. Nor is it to do with traditional notions of professional misconduct. The complaint is also very much to do with context: what is proper, or ‘behaviour unbecoming’ or ‘misconduct’, when a doctor assumes responsibility for communicating to millions of people ‘the facts’ about the risks and benefits of using a specified drug, when he also has unique access to the unpublished and most relevant data?

Another complication is that it seems impossible to measure with any precision the health impact of Dr Benbow’s advice – arguably the key indicator of appropriateness of behaviour. My sense is that, if he had been free to reflect what he knew (or ought to have known), and to promote his beliefs and values as a doctor, [a] Dr Benbow would have been very much more circumspect and honest in dealing with Panorama; and [b] this would have spared many people significant injury, loss and distress.

It seems relevant to note that there would be no grounds for complaint about Dr Benbow, had he complied with the terms of the pharmaceutical industry’s codes of practice for drug sales representatives – e.g. "Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication."

In this connection, you should be aware that, between 2001 and 2003, Social Audit made two separate complaints to the ‘Prescription Medicines Code of Practice Authority’ about gross misrepresentation of risk of dependence by GSK staff. Both complaints were lodged before Dr Benbow’s appearances on Panorama, and both were upheld. As Dr Benbow represented GlaxoSmithKline at the second hearing, he would have been familiar with the issues – including those relating to definition. Dr Benbow’s statements in the first Panorama programme cannot be reconciled with the relevant WHO advice on this subject. See attached letter (20 May 2002) and specifically the section on the definition of ‘dependence’:

Since publication of the ICD-10 guidelines, the World Health Organisation (1998) has published a statement on "Selective serotonin reuptake inhibitors and withdrawal reactions," which makes it clear: [a] that dependence should be regarded as not an ‘on or off’ phenomenon, but as a condition that should be measured by degree; [b] that on existing definitions, sensibly interpreted, SSRIs can and do cause ‘dependence’; and [c] that in the last analysis, the patient’s experience with the drug is the test of whether or not a drug causes dependence:

"There is obviously some confusion about the concept of dependence ... The simplest definition of drug dependence given by WHO is 'a need for repeated doses of the drug to feel good or to avoid feeling bad' (WHO, Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.

In general, all unpleasant withdrawal reactions have a certain potential to induce dependence and this risk may vary from person to person. Dependence will not occur if the withdrawal symptoms are so mild that all patients can easily tolerate them. With increasing severity, the likelihood of withdrawal reactions leading to dependence also increases …" (WHO Drug Information, 1998)

Should this case be progressed as a formal complaint, I would need to refer to other relevant documents on the Social Audit website. In the meantime, I hope that the programmes, transcripts and other materials I am sending will help you to determine whether and how you would wish to proceed.

You will appreciate that my underlying concern is about the meaning of being ‘a doctor’, and about the extent to which the public should trust that status, and depend on professional commitment to procuring health and doing no harm. To what extent should the public trust a doctor, when substantial conflicts of interest are involved? Perhaps Dr. Benbow’s fitness to practice is less important than the principle of the thing. I am very much open to suggestion, more concerned about the effective resolution of these concerns than about how this is achieved. I look forward to hearing from you

Sincerely,

Charles Medawar
Director

Attachments: DVDs and transcripts of Panorama programmes, Medicines out of Control? and other relevant materials. The reply from the GMC indicated a reply might be expected "within a couple of weeks". It took ten.

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