Panorama interactive forums

The links below will take you to three Panorama interactive web forums that took place after broadcasts of the Seroxat programmes.

They’re worth watching to see our good friend Alastair Benbow in full flow defending Seroxat as only he can… you also get to see Charles Medawar, David Healy and Andrew Herxheimer.

14 October 2002

11 May 2003

11 July 2003

Dr Greg Simon and his latest study

I just saw a post at Furious Seasons, about a new study – or rather about the press release for a new study as we haven’t been allowed to see the paper as yet:

“Turns out that getting treatment–meds, psychotherapy or both–works to eliminate suicide attempts soon after a patient begins treatment. Culled from 100,000 or so patient records by Seattle’s own Group Health Cooperative, the resultant paper is not yet available on the APA’s website. But in a press release, GHC’s Greg Simon notes… the study sheds new light on the “black box” advisory that the U.S. Food and Drug Administration (FDA) placed in 2004 and has revised since then, said Greg Simon, MD, MPH, the Group Health psychiatrist who led the study. The advisory—which has concerned many patients, families, and care providers—warns that suicidal behavior may emerge soon after people younger than 25 start treatment with newer antidepressant medications called selective serotonin reuptake inhibitors (SSRIs)….

Gerg Simon – that name rang a bell.

Now, let me see – Greg had produced another study in 2006 – its conclusions ran very much along the same lines .

This from Social Audit:

The Am J Psych decided that: “reconsideration of the FDA warning seems warranted”. This was on the basis of a major, NIH-funded, epidemiological study, published in the same issue that concluded, “Available data do not indicate a significant increase in risk of suicide or serious suicide attempt after starting treatment with newer antidepressant drugs”. Much publicity followed: “Antidepressants Seem to Cut Suicide Risk in Teenagers and Adults, Study says”, according to the New York Times.

After examining thousands of records in a Seattle-based, “consumer-governed”, non-profit health plan, the researchers reported that “suicide attempts decreased by over 60% in the first month of treatment”. As suicide attempts typically bring people into contact with doctors who then usually prescribe an antidepressant drug, this study just quantified the obvious: levels of suicidal behaviour tend to fall when people get help.

However, I think that you really need to read the whole exchange between Charles Medawar of Social Audit and Dr Greg Simon – I think you’ll get more of an idea of what Greg’s particular angle is…

This may also help as well – one of the study’s co-authors was Philip S Wang…

Can this be the same Philip S Wang that The Food and Drug Administration (FDA) had been urged to remove from one of its advisory boards evaluating the link between serotonin reuptake inhibitors (SSRIs) and suicide in youths because he had been a paid consultant for one of the companies that make the drugs under investigation?

Or the same Philip S Wang who served as an expert witness for Glaxo in a wrongful death suit involving Paxil.

Or the same Philip S Wang who appeared for Aventis in the case of Vera Easter verses Aventis Pasteur? Although Harvard-educated and the author of some 80 peer-reviewed articles, according to his deposition, Dr Philip Wang’s specialty was epidemiology related to antidepressants. Prior to being retained as an expert for the vaccine makers, Dr Wang had not done any evaluations associated with vaccines, had no specific training whatsoever regarding mercury, and had written no articles on the effects of heavy metal exposure.

Dr Wang has never investigated any illness claimed to be associated with heavy metal exposure and has never been asked to do a formal epidemiologic evaluation of the hypothesis that the thimerosal could cause neurological disorders or autism.

Dr Wang’s knowledge of vaccines and thimerosal was limited to what he learned in 30 to 35 hours of meetings with defense attorneys and reading the relevant medical literature, most of which was provided by the defense attorneys.

Or the same Philip S Wang who received $1.2 million from Kaiser Permanente, via the National Institute of Mental Health, to research Outreach and Treatment for Depression in the Labor Force. This project will involve an effectiveness trial to evaluate the impact of depression outreach-treatment of work-related behaviors.

I think I should point out that the National Institute of Mental Health funded the new study, whose other author is James Savarino – the same James Savarino who co-authored the earlier study with Dr Simon and Dr Wang.

The National Institute for Mental Health has a long and proud history of working closely with the drug industry.

Alastair Benbow and the General Medical Council – are the GMC protecting Benbow?

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
Dear Sirs,

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.

Yours faithfully
Charles Medawar
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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 [2007].

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.

Yours sincerely

Anna Neill
Investigation Manager
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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

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.
—————————————
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.

Yours sincerely

Tim Cox-Brown
Investigation Officer
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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.

Yours sincerely

Charles Medawar
Director
—————————————
From the GMC 31 May
Tim Cox-Brown (0161 923 6427)
TCoxbrown@gmc-uk.org

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.

Yours sincerely

Tim Cox-Brown
Investigation Officer

—————————————

You can find all my previous posts regarding Benbow, collected here for ease of reference.

Panorama interactive forums – watch here

I’ve just been prompted by an email from a friend to post up these links to three Panorama interactive web forums that took place after broadcasts of the Seroxat programmes.

They’re worth watching to see our good friend Alastair Benbow in full flow defending Seroxat as only he can… you also get to see Charles Medawar, David Healy and Andrew Herxheimer.

14 October 2002

11 May 2003

11 July 2003

Latest from Charles Medawar to the MHRA

Dear Sirs,

Please treat the following as a request under the FOI Act. I am seeking to establish whether and in what way the MHRA defines and requires appropriate standards of behaviour, and levels of personal responsibility, when Agency representatives [a] offer “information and advice to improve public and professional awareness”, when expected to reflect “robust and fact-based judgements”; and [b] are found to have made false, misleading and potentially damaging representations, albeit in good faith.

In this FOI request, I refer specifically to statements made by the MHRA Chairman, Professor Sir Alasdair Breckenridge, in the interview recorded for the BBC-1 Panorama programme, ‘Taken on Trust’, broadcast on 3 October 2004. A transcript of his broadcast remarks is available on the Panorama website, but in framing this FOI request I have also taken account of context, given the reservations expressed by Sir Alasdair in his evidence to the House of Commons Health Select Committee (20 January 2005, at Q815): “The bits of my robust defence of the position of the Agency were not shown and I cringed from behind the sofa when I saw the bits they did show of what I had said. It was very embarrassing”

In the broadcast programme, Breckenridge stated: “There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults”. This claim appears fully consistent with other statements Breckenridge made when interviewed. He was asked: “Why should the public now trust you when you say the benefits outweigh the risks in adults?” He replied: “Because of overwhelming evidence that it does … we have looked at over 300 studies of Seroxat in adults”. Later in the same interview, he emphasised the same point: “There are in over 300 studies which have been analysed and studies using epidemiological databases the drugs do not cause suicide, they do not cause suicidal thoughts.”

The following FOI requests arise in the light of evidence to the contrary that was available at the time this interview took place, notably from data provided to the CSM/MHRA Expert Working Group on SSRI antidepressants. However, the relevance of these FOI requests is underlined by information made available since then – notably in May 2006 by GlaxoSmithKline (GSK), following the independent re-examination of essentially the same data, and in the December 2006 hearings by the US Food & Drugs Administration Psychopharmacologic Drugs Advisory Committee.

1. Does the Agency consider that the categorical assurances given by the Chairman, and his references to “overwhelming evidence” in support of his views, were justified in the light of the conclusion of the Expert Working Group on SSRI antidepressants: “From the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out”?

2. In the broadcast interview, the MHRA Chairman sought to explain the linkage between onset of treatment and emergence of suicidal behaviour solely in terms of the delayed onset of drug effect, again wholly discounting the possibility of drug induced suicidal behaviour:
BRECKENRIDGE: There is a period of time when the drug does not act, it takes a period of 3 or 4 weeks before effect.
JOFRE: But it’s in your bloodstream immediately. Are you suggesting it has no effect on you?
BRECKENRIDGE: It has no beneficial effect for some 3 or 4 weeks.
JOFRE: But it might have a detrimental effect.
BRECKENRIDGE: And during that period of time there is a risk of suicide which remains from the period as before, and that is the period when the practitioner must monitor the patient very carefully.

Does the Agency consider that this assumption by Breckenridge was justified in the light of the conclusion of the CSM/MHRA Expert Working Group on SSRI antidepressants? (e.g. “It is very difficult to assess whether these reactions are due to the drug, would have occurred if the person was treated with any antidepressant, or are part of the underlying course of the disease.” And: “This may be suggestive of a causal association but also may be due to the fact that an event occurring shortly after treatment initiation is far more likely to be linked to the treatment by the patient and the prescriber than an event occurring after some time on the drug.”)

3. In the course of the Panorama interview, the MHRA Chairman stated: “In fact, what you can say is, that the prescribing of SSRIs has increased dramatically since the 1980s, end of the 1980s (and) the risk of suicide has fallen dramatically in that period of time.” Does the Agency consider this to be “a reliable and fact-based judgement”, taking into account the conclusion of the Expert Working Group, that: “Studies generally indicate that increases in the prescribing of SSRIs have not been associated with an increase in population suicide rates, although interpretation of these findings is difficult …”

4. In the broadcast interview, Breckenridge stated: “In the adult population the drugs are effective. There are many, many studies to show that.” Does the MHRA accept [i] that of the order of two-thirds of all SSRI prescriptions for depression are written for “mild depression”? [ii] that the EWG was correct in concluding that, “The effectiveness of SSRIs in mild depression has not been clearly demonstrated in RCTs”? And [iii] that the MHRA Chairman therefore failed to comply with the MHRA’s mission, to give “robust and fact-based judgements to ensure that benefits to patients and the public justify the risks”?

In relation to each and all of the above:
5. Does the MHRA now accept that Breckenridge’s assessment of the risk of paroxetine-induced suicidal behaviour in adults was inappropriate and/or unreliable, and therefore did not reflect the “robust and fact-based judgements” that the Agency claims underpins its work?

6. Has either the Agency, or its Chairman, ever withdrawn or apologised for these broadcast remarks? Has any consideration ever been given to doing so? If so, please provide relevant documentary evidence?

7. Did the Chairman undertake any media training, rehearsal and/or formal preparation for this Panorama interview – and please give details if so. Whether or not he did, [i] please identify by date and title any memoranda, briefing notes or advice prepared by or for the Chairman in advance of this interview; and [ii] please disclose the contents of all such documentation.

8. Did the Agency make any assessment either of that Panorama programme and/or of the Chairman’s performance in his broadcast interview? If so, please provide a copy of any appraisal(s) made.

9. Did the Agency, or the Chairman, make any representations to the BBC, following the broadcast interview, to complain of unfair or unjustified treatment of either the subject matter or the Chairman (e.g. relating to his complaint to the Health Committee, referred to above)? If so, please provide a copy of any representation(s) made.

10. Please provide any documentary evidence to show what lessons the Agency learned, following the independent re-analysis of paroxetine clinical trial data, leading to the May 2006 statement by GSK? Specifically, did the Agency consider [i] that the Expert Working Group had been unwise to rely on company analyses of those trial data; and [ii] that Agency representatives should be restrained from making bullish presentations, in the absence of fully reliable analyses and data?

I look forward to receiving the Agency’s response to these questions. In framing them, I have been mindful of the requirements put on pharmaceutical sales representatives under the ABPI Code of Practice for the Pharmaceutical Industry, and specifically clauses 7.2 and 20.2:

7.2 Information, claims and comparison, must be accurate, balanced, fair, objective and unambiguous and must be based on an up to date evaluation of all the evidence and reflect that evidence clearly. They must not mislead, either directly or by implication, by distortion, exaggeration or undue emphasis”
20.2 Information about prescription only medicines which is made available to the public either directly or indirectly must be factual and presented in a balanced way.

I would need some persuading that the MHRA Chairman would have passed such tests. On the other hand, it would be encouraging to find evidence that lessons had been learned. Failing that, I shall seriously consider passing this and further evidence to the Fitness to Practice Directorate of the General Medical Council.

Yours faithfully,

Charles Medawar
Director
Social Audit

[If you want to watch Breckenridge in action - in the very interview cited above, then you can do so here.]

The retiring Charles Medawar!

I owe Charles Medawar a lot.

It was his book Medicines out of Control that opened my eyes and, in hindsight, helped me deal with my own prolonged withdrawal.

Through his website, Social Audit, I discovered that it wasn’t just me the MHRA was jerking around – there are many important questions being asked but the MHRA is not going to be the organisation to give us any answers.

He inspired me to do something – this is it.

Anyway there I was, happily working my through the latest update from Social Audit when my attention was taken by “No cards please”.

I’ll leave you to read it – but it does seem as though Charles is retiring from Social Audit.

I hope that his retirement plans do not include a bungalow near Bournemouth or a round the world cruise on the QE2.

What his plans actually are I do not know, but I trust they will involve the use of a computer and the internet… There’s too much left undone to stop now!

That’s it really – I’d just like to say thanks very much.

Where do we go from here?

So, where do we go from here?

My thanks to Charles Medawar of Social Audit for this summing up:

In the immediate future, there is potential for progress on three main fronts – none politically attractive, though all central to the future health and reputation of pharmaceutical medicine.

First, we need urgently to examine the meaning of personal responsibility in corporate settings: specifically, the General Medical Council (GMC) should now investigate and rule on the conduct of Dr Alastair Benbow. Both would in some way be on trial. The GMC is a professional court with feudal if honourable traditions, with still some way to catch up with the climate of the late 20th century. As for Dr. Benbow, he seemed so sincere in his advocacy for the drug, so replete with reassurance, that his position must now be clarified. Did he critically review the relevant scientific evidence before making these claims? Was he a leader in some cynical process, or kept well ignorant and brilliantly coached in his denials? The latter seems much more probable, but we need to know for sure. Are these horrible and damaging drug disasters driven by knaves, fools, or victims – or some, none or all of the above? The GMC must now rise to the occasion: we need some definitive view.

Secondly, what of the proposed prosecution of GlaxoSmithKline by the UK authorities (led by the Medicines and Healthcare products Regulatory Agency)? In the USA, civil actions will progress later this year, seeking to link the now damning factual evidence with tragic human consequences. But in Britain, are we now due for a replay of Prime Minister Blair’s recent decision to abort the bribery investigation into British Aerospace (BAE), on the grounds of national interest and security? What is the MHRA up to? Their last word (7 April 2006) was this: “The conduct of the investigation required the Enforcement Division of the MHRA to consider over a million pages of scientific and other documentation which comprised the factual background to the case. A team of medics and scientists from across the MHRA assisted with this. The process of considering documents is now completed and documents are only reviewed now if they come to light as new evidence. Potential witnesses from inside the MHRA have been interviewed and notes have been taken from them, from which statements will be drafted. These statements seek to convert the findings of the review of the scientific and regulatory documentation in to evidence suitable for the conduct of a criminal trial, if appropriate … once the criminal investigation has been concluded a file will be forwarded to prosecuting lawyers within the legal department of the Department of Health. They will apply the Code for Crown Prosecutors to decide whether or not there will be a prosecution.”

Thirdly, we urgently need some proper enquiry into the conduct and effectiveness of the UK drug regulators themselves – the Medicines and Healthcare products Regulatory Agency (MHRA) – in line with the 2005 recommendations of the Parliamentary Health Committee, in its report on ‘The Influence of the Pharmaceutical Industry’. The evidence from this and earlier Panorama programmes hugely underlines the importance of this main recommendation: “During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA …”

Oh yes – and we also go to the High Court taking Glaxo with us.

Social Audit, Panorama, Glaxo and the MHRA

The inimitable Charles Medawar weighs in with his commentary on last night’s Panorama programme. He writes:

“Panorama (BBC-TV) last night broadcast its fourth programme on Seroxat® (paroxetine), a still deeper foray into the built-in nastiness of drug marketing and product promotion. All credit to the programme for sticking with the issue, if only to reveal how much more must be done to see this story through.

Thanks largely to Panorama and friends we now have a pretty clear picture of motive, opportunity, method and the sometimes awful consequences. Corrupting influence in pharmaceutical science has become almost natural and easy – the product not only of greed and self-interest, but of established professional and organisational practice. In some ways, collective lack of commitment and imagination seem to trump venality. Indifference rules, OK?

The more this story unfolds, the more scary seems the inter-dependence and over-connectedness of the three main powers. Between them, the Pharmas and their agents, governments and regulators, and doctors and research workers have constructed a ‘health-care’ system that now seems, almost routinely, to put health second and them on top.”

To see where we go from here please visit the Social Audit website and read the full article.

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