Below you will find a sequence of correspondence between Charles Medawar of Social Audit and the General Medical Council. It seems the GMC does not want to investigate Dr Alastair Benbow, despite what he has said in public, on more than one occasion regarding the safety and side effects of Seroxat “…In short, and in the light of the evidence that has since become publicly available, this man’s statements on television leave the impression that he conceived his primary duty of care to be to his employers, rather than to the many people (including health professionals) likely to have trusted his judgment as a doctor…”
Now read on:
1 February 2007
I am writing to enquire about the possibilities and appropriate procedures for making a complaint about a registered medical practitioner, in circumstances which do not appear to be covered by the guidance given on the GMC website. I should be grateful for your advice about how to proceed, in the light of the following possibly complicating factors:
1. The complaint I seek to bring does not directly relate to standards of treatment or practice by the individual concerned. I am not a patient of the doctor in question, nor do I have reason to believe that he lacks qualities that would call into question his fitness to practice medicine in a clinical setting. My concern is about the conduct of medically qualified individuals in an institutional/organisational setting.
2. The subject of this prospective complaint is a well qualified physician who acted as the principal spokesperson for the manufacturers (his employers) of a widely prescribed antidepressant drug. I would wish to allege that, in that capacity, and on several occasions, he offered inappropriately reassuring advice about the safety profile (benefit-to-harm ratio) of that drug, in programmes broadcast on television (Panorama: BBC-TV), distributed worldwide. I would wish to allege [a] that his statements were (by omission and/or commission) inaccurate, misleading and possibly reckless; [b] that the statements he made did not reflect the evidence to which he had unique access, whether or not he availed himself of those data. (It is relevant to note here that some submissions to the UK drug regulatory authorities were made in his name); and [c] that substantial harm very probably resulted from his failure either to critically assess the evidence available to him, and/or to his presumption that there was no cause for concern.
In short, and in the light of the evidence that has since become publicly available, this man’s statements on television leave the impression that he conceived his primary duty of care to be to his employers, rather than to the many people (including health professionals) likely to have trusted his judgment as a doctor, and to have been influenced by the reassurances he gave. (Panorama has broadcast four programmes on this subject and this man was interviewed for the first two, but made appearances in all four). I believe that, in the UK, the audience for each of these programmes has been over 3.5 million viewers).
3. My status as a prospective complainant is untypical. The complaint I would wish to bring would and should be in my name – but in my professional capacity as a medicines policy analyst and reporter, with a particular interest in the marketing and effects of this (and related) medicinal products. Therefore it would also seem most appropriate to bring forward any complaint under the letterhead of the organisation (Social Audit Ltd) which employs me in this capacity.
By way of background information, I am enclosing a copy of the review posted to the Social Audit website of the Panorama programme broadcast on 29 January: http://www.socialaudit.org.uk now gets >750,000 visits/year.
I understand this review is to also be posted to bmj.com
I would welcome your advice on how best to proceed. Thank you for your attention; I look forward to hearing from you.
From the GMC 22 February
Dear Mr Medawar
Your complaint about Dr Alastair Benbow
Thank you for your letter of the 1 February 2007.
The main statutory objective of the GMC is to protect, promote and maintain the health and safety of the public. One of the ways in which we do this is by maintaining the integrity of the medical register (on which all doctors wishing to practice medicine in the United Kingdom must be included) by ensuring that those doctors on the register are fit to practice and taking appropriate and proportionate action against those whose fitness to practise may be “impaired” (by virtue of misconduct, ill-health, performance, criminal conviction or regulatory determination). Should we continue with your complaint it would almost certainly fall within the misconduct category.
Your complaint appears to relate to statements made by Dr Benbow, in his capacity as head of European clinical psychiatry at GIaxoSmithKline, on two Panorama programmes in relation to the safety (benefit to harm ratio) of paroxetine (seroxat) on depressed adolescents and children. You have helpfully enclosed with your complaint a copy of a review of his and others comments made on the programme(s), which was posted to the Social Audit website following a broadcast of one of the programmes on the 29 January .
In order for the GMC to determine whether Dr Benbow’s fitness to practise may be impaired by reason of misconduct we would need to consider the nature of the allegations you are making (taking into account all the circumstances of the case and our guidance in Good Medical Practice) and whether there is tangible evidence to support a finding of misconduct.
Whilst I appreciate that Dr Benbow’s comments have caused you concern, at present there is nothing in your complaint in its current form to suggest that his medical abilities are affected as a result of the comments you say he made. Therefore, if you wish the GMC to consider this matter further I should be grateful if you would provide me with further details of the allegations you are seeking to make against Dr Benbow, including specific details of exactly which comments you take issue with, when and in what context they were made, and why you take issue with them. If you have any documentation which would support your complaint, then I would be grateful if you could supply this. It would be of particular help if you could provide me with a videotape or DVD of the programmes in question if you are able to do so.
I look forward to hearing from you by Friday 2 March 2007.
From Charles Medawar 28 February 2007
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
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.
From the GMC 11 May
Dear Mr Medawar
I am writing further to your correspondence about Dr Alistair Benbow. I am sorry for the delay in our response.
From the information that you have provided so far, we cannot identify any issues that would enable us to conduct an investigation into Dr Benbow’s practice. In the absence of any clear criminal or other regulatory proceedings relating to the research into, and/or production or marketing of, Seroxat, to which Dr Benbow can be directly linked, there is no information available to us which could amount to an allegation of misconduct capable of calling into question Dr Benbow’s fitness to practise.
We are also of the view that it would be disproportionate and/or premature for us to commence an investigation at this stage for the purposes of searching for information or evidence sufficient to make an allegation regarding Dr Benbow’s fitness to practise.
We do not have information sufficient to make (or support) an allegation that Dr Benbow’s fitness to practise may be impaired. Although our file in this matter is now closed, this will not preclude us from reconsidering this matter in future, should new information or evidence come to light, which indicates that Dr Benbow’s fitness to practise might be called into question.
Please find enclosed your DVD, as requested. We have not taken a copy.
From Charles Medawar 24 May 2007
Dear Mr Cox-Brown
Thank you for your letter of 11 May (Ref E1-6XK3V) in response to my enquiries dated 1st and 28th February. Thank you too for returning the Panorama DVD that I sent to Anna Neill. I received both on 18 May, several days after I had read the duplicate letter you sent to another complainant, Mr. Derek Brown. He posted your correspondence on the Internet, but you should know that I had no contact with Mr. Brown on this matter: these were independent complaints, albeit prompted by many of the same concerns.
I am now minded to post our correspondence on the Social Audit website (>1m visits/year), to allow others to decide whether my enquiry was handled appropriately. My view is that this response casts doubt on the General Medical Council’s own fitness for purpose. The response to date signals to me lack of competence, capacity, imagination, independence and commitment to health, though in what proportions I can’t be sure.
I was struck by the emptiness of your letter. Everything you wrote emphasised that the GMC believes nothing can or should be done. The available evidence was sufficient to persuade Panorama to complain that Dr Benbow, representing himself as expert, had broadcast false and misleading statements about the safety of Seroxat (paroxetine). Yet the GMC seems unconcerned.
Is this really in the public interest, and in line with public expectations of the GMC? I very much hope not. It seems absurd that the GMC should be satisfied with the conduct of a registered medical practitioner, even when he/she falls short of pharmaceutical industry standards for drug sales representatives:
“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.”
I bent over backwards to explain that I don’t have it in for Dr Benbow either as a clinician or personally but – along with many others – I am extremely concerned that any doctor should so uncritically toe the company line, when evidence of drug risk and harm is so strong. The generic issues seem critical: are doctors who speak for drug companies under too much pressure or otherwise professionally compromised? Are they simply to be regarded as company spokespeople, owing correspondingly less to the public by way of duty of care? It seems really feeble that the GMC should conclude so blandly, authoritatively and emphatically that there is nothing to be said, case closed.
The GMC’s position seems all the more unacceptable given that your President recently, if unwittingly, instigated an oppressive investigation of Professor David Healy, on the basis of ropey evidence and dark hints. On that occasion, a bit of deviously orchestrated and nasty gossip was sufficient for the GMC to require Dr. Healy to justify, in some detail, his fitness to practice as a doctor. I suppose it is to the GMC’s credit that they later concluded there was no case to answer; several major pharmaceutical companies would have been well pleased if this monstrous complaint had been pursued.
Here too, the GMC seems to have missed the point. Commercial influence now has profound effects on the ethos of medicine, clinical practice and patients’ health – some undoubtedly welcome, but others unquestionably not. If the GMC wasn’t concerned about the evidence from Dr Benbow, it would strike at the heart of evidence-based clinical medicine. I’d be reassured to think that, as a matter of urgency, the GMC was at least thinking about giving guidance on the subject – strong enough to protect the conscience of honest doctors employed by drug companies.
Both to protect Dr Benbow’s reputation, and to safeguard its own credibility, I suggest that the GMC should now state publicly [a] whether or not Dr Benbow was asked to respond to any allegations? [b] whether and in what manner Dr Benbow explained his position to the GMC? [c] whether or not the GMC accepted evidence from Dr Benbow that he had faithfully described the risks and harms of paroxetine known to him? [d] that the GMC was satisfied that the evidence of risks and harms of paroxetine that were uniquely available to Dr Benbow was satisfactorily communicated and [e] whether he explained to the GMC’s satisfaction that his performance on Panorama was sufficiently guided by the truth, the whole truth and nothing but the truth.
One should expect nothing less from an honourable doctor than from a witness in court, but where does the GMC stand? The question is not rhetorical, but nor am I prepared to fall in with the executive propensity for delay. If you or anyone else from the GMC were to pick up the phone within the next working day or two, I would sympathetically engage in any discussion relating to issues, publicity and engagement – even on off-the-record terms, if that were to serve some greater good. An alternative might be Judicial Review.
From the GMC 31 May
Tim Cox-Brown (0161 923 6427)
Dear Mr Medawar
Thank you for your letter of 24 May 2007.
We are currently considering your comments and we will contact you again in due course.