| April 2008 On the road to Pharmageddon? See Social Audit's response to the proposal to allow the pharmaceutical industry to communicate directly to consumers ... "DG Enterprise & Industry completely fails to appreciate that you paralyse the healthy human response, once people come to believe that their genes, body chemistry, and social and cosmetic camouflage are key to developing health and well-being. These proposals take absurdly for granted the benefits of technological and medical intervention ..." | ||
| March 2008 See:
Pharmageddon: health climate change? This
piece reviews the project so far and links to the 15 abstracts from outside contributors
that the judges thought especially good. Each published abstract receives an award of
€1,000, thanks to a grant from the Allen Lane Foundation. Congratulations to
the winners, and many thanks to everyone who took part.
[28 March] [5th March] Meanwhile - nearly five years on - we are just a few hours away from learning whether or not the MHRA has decided to prosecute GlaxoSmithKline. Yes, the MHRA would see advantages to keeping the lid on - sub judice perhaps for a few more years. But it would be an extraordinary thing to do. Read on. |
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| October
2007 The
Allen Lane Foundation has just awarded Social Audit a grant of £10,000 to explore Pharmageddon
- “the prospect of a world in which medicines and medicine produce more ill-health
than health, and when medical progress does more harm than good”. We have therefore doubled
the prizes/grants on offer for the best Abstracts we receive by the end of the year. Read on: 350 words to come ... (22 October) Postscript: Pharmageddon in 350 words? Is that all? (26 October) |
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| September 2007 Here
is a <350-word piece – the basis of a presentation next month at the Health Action
International AGM – outlining the core dynamics of
the threat of Pharmageddon. This is the Third Call for Abstracts for the inaugural conference on Pharmageddon? and we are offering upwards of eight awards of €1,000 each for Abstracts posted on this website (>one million visits per year). The rules are simple: in no more than 350 words, write an Abstract (not the paper) for a presentation that you would want to give or hear at this conference on Pharmageddon? Closing date: 31 December 2007. |
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| August 2007 This is a second call for Abstracts for the inaugural conference on Pharmageddon? We are very pleased to have received the ten sent in so far. | ||
| July 2007
Here are links
to Pharmageddon? which has now has a
definition: "the prospect of a world in which medicines and medicine produce more
ill-health than health, and when medical progress does more harm than good". See also accompanying references and notes. By way of stimulating enquiry, consultation and worthwhile peer review, Social Audit is offering at least eight prizes of €1,000 each (more if we find a good sponsor) for any <350 word responses published on this website. See: Call for Abstracts |
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| June 2007 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 a drug, when he/she also has unique access to the unpublished and most relevant data? This correspondence about GSK's Dr Alastair Benbow calls into question the General Medical Council's fitness for purpose in "regulating doctors" and "ensuring good medical practice". To date, the GMC has offered precious little evidence of its commitment and capacity to do either - but 20 weeks later, they say they are still thinking about it, and will respond "in due course". | ||
| March 2007
An MHRA spokeswoman writes: "I would like to reassure you
that our Chairman and other spokespeople for the MHRA always ensure that they give robust
and fact based judgements to ensure that benefits to patients and the public justify the
risks". You bet she would, but she is far off the mark. See editorial note, BRECKENRIDGE: WHERE NOW? and related correspondence with the MHRA. POSTSCRIPT. The MHRA has now clarified its claim that the investigation of GlaxoSmithKline has been newly invigorated. Not so. |
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| February
2007
The
MHRA has, to date, spent between 14 and 30 person years (maybe £1m of drug industry
funding) in not deciding to prosecute GlaxoSmithKline, since its investigation began in
October 2003. Last month the Agency told Panorama, "that the investigation has been given substantial additional
resources and remains a high priority" -
but their latest communication
on the subject suggests anything but - that 'high priority' stuff seems to be a media sop,
a trip off some tongue in the Agency's "Communication Division". Do read this
mail, if only to savour the tone: the writer rounds off a spluttering (spitting?) blast of
disinformation with, "I hope this is helpful". The MHRA's response seems no more
helpful than straight - but this is their view. The reality is that any prosecution of the Company would put the Agency itself - and Chairman Breckenridge in particular - too squarely in the frame. What was it he told Panorama for the second of their four splendid programmes? (11 May 2003) - "What you can say with great firmness is that these drugs do not increase the risk of suicidal thought and they do not increase the risk of suicide". If that's the Agency's best assessment after more than a decade of drug investigation, personally spearheaded by the blunt tool, Breckenridge, why should the law expect GSK to do any better? I'd sooner argue that GlaxoSmithKline was fit for purpose (serving shareholders), than the MHRA (safeguarding public health). Professor Sir Alasdair Breckenridge clearly should have retired some time ago - indeed he should never have been appointed. But rather than dwell on his fitness for public purpose, here are some reflections on my own retirement: no cards please. We regret that we have had to suspend the Discussion Board. We're trying to fix the problems and hope to get it up and running again before too long. One problem is to do with avoiding vast amounts of sickening spam. Unsurprisingly, much of it offers prescription drugs for sale - most of them dependence producing, and including SSRIs. |
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| January 2007 Panorama
(BBC-TV) last night broadcast its fourth programme on Seroxat® (paroxetine), a still
deeper foray into the built-in nastiness of drug marketing. See review: ‘What
they’ve done is just despicable …’ Meanwhile,
has the MHRA made any progress with its proposed
prosecution of GlaxoSmithKline? Expectations should be be kept very low, to judge by the
Agency’s po-faced response to our request for a modicum of personal responsibility by
Agency staff. No, the MHRA won’t reveal the authorship (or recipients) of misleading
texts about the Seroxat placebo suicides. They have decided
to withhold the names of Wark, Fawbert et al, on the extraordinary grounds that this is
“information whose disclosure would be likely to endanger the physical or mental
health or the safety of any individual”. |
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| December
2006 The MHRA has published the summary
findings of a survey into public and professional attitudes to drug safety and the
effectiveness of regulation. See note: Ignorance is Bliss? Interaction of antidepressants with alcohol? Social Audit is collaborating with two doctors studying this potentially important but neglected topic, and is appealing for help with the research. |
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| November
2006 (061128) Here are the MHRA
responses to two recent FOI requests. One is about the
Agency's public relations and consultancy contracts. The other
painfully continues the correspondence about the Seroxat/paroxetine placebo suicides. An
editorial note, MHRA COMMUNICATIONS STRATEGY (IN A NUTSHELL) briefly contrasts
these two replies. Another note, MHRA ABUSE OF FOIA
EXEMPTIONS? comments on the
MHRA’s tendency to exempt itself from identifying the Agency staff responsible for
this and that, using section 40 of the Freedom of Information Act. The point is pursued in another letter to Special Agent Fawbert,
with a request for a formal review. The Goverment wants to increase the fees charged for handling Freedom of Information requests. Apart from reneging on a ministerial pledge, how can this be justified if government departments don't keep stock of their own waste of resources and opportunities to cut costs? It can't. See: HOW MUCH DOES THE MHRA CONTRIBUTE TO THE COSTS OF FOI? Postscript: Congratulations to the MHRA Policy Division for responding to the six related FOI requests in this paper, in record time: 22hrs 50m. The paper has therefore been updated, and the argument strengthened with the new evidence supplied. UK citizens and residents may wish to sign the related petition on the 10 Downing Street website, and encourage others to do so. (061105)
An FOI communiqué from Special Agent F, |
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| October
2006 Re: a new development
relating to the Seroxat 'placebo suicides" - see further correspondence
with the MHRA ... "I could not
work out from the tone of your email whether you either horribly did or horribly did not
appreciate the significance of the issue. The admission you make had last straw written
all over it, yet your email seemed almost dangerously bland. I’m still puzzling over
it. I suspect that it was quite carefully deliberated and crafted, yet it may just reflect
how disintegrated the Agency is, and simply be text of the kind that is routinely extruded
from the MHRA in the due course of due process. To help me understand the relative
contributions of incompetence and/or mendacity and/or whatever else, I would be grateful
if you could address the following points ..." Amplification/clarification of FOI request relating to reports on quality of service and communication, and safety of medicinal products, commissioned by the MHRA (2003-2006) |
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| September 2006 Still more on the culture of mendacity in the MHRA (Medicines and Healthcare products Regulatory Agency). See annotated notes (including two more FOI requests): DELAY BREEDS CORRUPTION and NEW SEROXAT/PAROXETINE PRESCRIBING ADVICE. | ||
| August
2006 Forever consumed by process and
mindless precision - rather than accuracy and common sense - the MHRA continues to duck,
weave and delay ... read on See also, conclusion of the correspondence about misleading advertising of Efexor XL. The MHRA have simply trackchanged their published rules: "A corrective statement is / NOT a statement published by an advertiser in the same publication where the advertisement ... was originally published. It is / NOT of similar size to the originally published advertisement …" |
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| July
2006 More on the
culture of mendacity: the MHRA has now responded to our
complaint about the Agency's cover-up of the so-called
"Placebo Suicides" involved in clinical trials of paroxetine (Seroxat/Paxil). It
took the MHRA ten weeks to produce their 'review', a
monumentally trivial assessment of the issues - yet in its own way a little gem: "what
has emerged is a classic case-history from which I expect to be extrapolating for years."
See correspondence, including further requests for information about the roles, responsibilities
and actions of some of the main players involved. See also: continuing correspondence about misleading advertising of the antidepressant, Efexor XR - well over a year after the original sin, another twist, another turn ... |
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| 20 June 2006 Patients and consumers of medicines, as well as health professionals, should be up in arms about the Department of Health's decision to stop funding the Drug and Therapeutics Bulletin. Read on | ||
| 17 June 2006 See conclusion of correspondence
with the MHRA about the three, so-called "Placebo Suicides" involved in clinical
trials of paroxetine. What a shambles and what a sham: "This whole episode leaves me feeling that the MHRA is absolutely not
to be trusted and that something of a culture of mendacity seems to prevail. Please add
this to the complaint this correspondence has already generated." Surprise: about one-third of the patients on paroxetine, who were included in the MHRA Expert Working Group's analysis of drug-induced suicidality, were in fact taking a controlled-release version of that drug (Paxil CR) that has never been licensed for use in the UK. The MHRA seems to assume this makes no difference - but the evidence hardly supports them. See also continuing correspondence with the MHRA about misleading advertising of Efexor XL (venlafaxine). |
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| 15 June 2006 The Birthday Honours list is now due. Who's next in line in the UK medicines' control system - and what did they do to deserve it? Read on ... | ||
| 25 May 2006 ADWEB discussion forum modified and restored (See 22 April entry below) | ||
| 23 May 2006 Notes: Suicide Risk During Antidepressant Treatment (Simon et al., 2006). See also HAI(E) paper on post-marketing safety monitoring of drugs (pharmacovigilance). | ||
| 15 May 2006 The Seroxat/Paxil
story is far from over, in spite of the monumental admission this week by GlaxoSmithKline
(GSK) that depressed adults
treated with paroxetine might be six times more likely to exhibit suicidal behaviour than
matched adults treated with placebo. There is a whole new chapter to be written, but it
will take more than this to sort out the underlying problem: the management of drug health
and safety issues is in some ways intensely poor. This new, improved analysis of the risk of adult suicidality is mostly of data from clinical trials conducted 10 years ago or more. The main thing new is that this was the first independent analysis based on a blinded re-evaluation of the raw data. When the UK drug regulators, the MHRA, ran their ‘independent’ investigation of SSRI antidepressants, in 2003-4, they relied not on the raw data, but on summaries and analyses the manufacturers had prepared. The limitations of this approach are evident from our on-going correspondence with the MHRA about the true nature of the so-called ‘placebo suicides’ reported in paroxetine-versus- placebo clinical trials. Briefly, both the MHRA and the European regulators (EMEA) accepted the company’s claim that, in these trials, three people on placebo committed suicide, compared with only one person on paroxetine. This was a key finding and central to the regulators’ enquiries, but an inherently implausible result. Moreover, it was based on brief summary evidence provided by a company then (and still) under investigation for suspected concealment of related evidence. Nevertheless, EMEA, the MHRA and its Expert Working Group saw no need to examine the raw data. Those data are now in the public domain and they demonstrate that the three ‘placebo suicides’ were no such thing. Now it is up to the regulators to respond to our complaint that they have systematically deceived others as well as deluding themselves. Read on ... See also: tail-end of correspondence with the MHRA about the Chairman's penchant for playing the stockmarket, and correspondence about misleading advertising of Efexor XL (venlafaxine). This case was significant partly because the MHRA had originally pre-vetted and approved the offending advertisement, later to uphold the complaint and require it to be withdrawn. We hope to restore the Social Audit discussion site very soon. See below. |
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| 22 April 2006 For several weeks the Social Audit discussion room has been the target of spam attacks, mainly from phoney sites claiming to sell drugs, cars, ring-tones etc. By 20th April, the volume of this stuff had reached several thousand 'messages' a day, so it was time to pull the plug. Apologies, but the discussion section of the site will not be accessible for a few days while we try to fix things. We'll open it up again as soon as we can. Thanks for your patience and understanding - CM | ||
| 25 June 2005 See annotations added to note: Taking stock of the MHRA | ||
| 15 June 2005 The MHRA has responded to the complaint that its regulation of SSRI antidepressants remains chaotic and misconceived. Meanwhile, the Agency and the Department of Health are on the point of responding to the 5th April report of the House of Commons Health Committee into, "The Influence of the Pharmaceutical Industry". See related editorial note and linked correspondence relating to the MHRA’s chairman’s recreational interest in the stockmarket. See also complaint about the Agency’s serial failure to post minutes of the CSM’s sub-committee on pharmacovigilance (SCOP). | ||
| 20 April 2005 The overwhelming emphasis in the investigation of SSRIs has so far been on trying to quantify levels of risk and harm – but perhaps this is looking at the problem upside-down? Surely the scale of the problem has more to do with the lack of evidence of SSRI efficacy, and the continuing failure to warn that most users gain little but risk losing a lot. The need for and value of drug treatment for severe and moderate depression is not in question, but most prescriptions are written for mild depression where the benefit:risk equation is poor. This is the issue addressed in this further complaint of regulatory maladministration. | ||
| 9
February 2005 Here is a short postscript to the review of the Expert Working Group report on SSRI antidepressants. Annotations will follow. See also this note about regulatory perceptions of benefit and risk - in relation to atomoxetine (Strattera) and more generally. Online debate: "Do we need tougher measures to ensure drugs are safe? |
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| 21
January 2005 Here is something of a conclusion to the review of the Expert Working Group report on SSRI antidepressants. It is sweeping and very brief - at present merely a skeleton of text. It will be illuminated in future by way of hyperlinked annotations. Finally we learn that the MHRA had nothing to declare. |
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| 7
January 2005 Here is the third instalment (5 January) of the continuing review of the report of the CSM Expert Work Group on the safety of SSRI and related antidepressants. See also editorial note,'Dear Mr Alder'. Meanwhile, correspondence with MHRA Chairman has stalled: over three months and still waiting... |
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| 17 December 2004 The report of the CSM Expert Work Group on the Safety of Selective Serotonin Reuptake Inhibitor antidepressants was released to the press on 6 December and posted on the MHRA website a week later. It will take time to digest, but here are the first (10 December) and second (17 December) instalments of an on-going review. |
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| 3 December 2004 Apologies for the lack of updates since June 2004, especially when so much is buzzing. One reason is commitment to other work (1). Meanwhile, our correspondence with the MHRA has progressed, and Social Audit’s core concerns remain as defined in Medicines out of Control? Reviews of this book have now started to appear, and we have posted those we have seen. (Please also note that this book is no longer available through the original publishers; orders should be sent to us). The lack of update is also because the CSM/MHRA expert working group on the safety of SSRIs has yet to produce a final report. The grapevine suggests that an announcement is due on 6 December and posted to its website a week later – but there have been three postponements so far, so further delays wouldn't be too surprising. See: ANTICIPATING COMPLETION OF THE REVIEW OF SSRIs (posted 3 December). See also: Correspondence re the implementation of the Freedom of Information Act 2000 |
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| June
2004 Parliamentary Questions, SSRIs and medicines' control SSRI Review: the meaning of the delay Taxonomy of problems in medicines' control |
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| May 2004The future of direct patient reporting of ADRs Restricted access to Yellow Card data Is antidepressant suicidality really an age-related effect? A breathtaking perspective on drug effectiveness | ||
| April 2004 Two important papers come to essentially the same critical point. When you pool the available data on the safety and effectiveness of SSRIs in childhood depression, evidence of effectiveness over placebo is absent or slight, while the risks of adverse effects, sometimes including drug-induced suicidal feelings and actions, are increased. See also Medicines out of Control? pages 202-205.
US Congressional Committee on Energy & Commerce gets a response from the FDA to enquiries about the non-appearance of Dr Andrew Mosholder, at the FDA’s February hearings. The Committee chairman reported: "FDA's primary medical reviewer believed that the available data were sufficient to conclude an association exists between the use of antidepressants and suicidal behavior in children. He also recommended that action occur without further delay, although others at FDA disagreed with his recommendation. There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public. The Committee will pursue these questions and, given the public interest in resolving this matter, a hearing is one potential means by which to gather further information." Scottish Association of mental health publishes results of major survey of user experience of drug prescribing and use. See www.samh.org.uk Publicationof the Paxil Withdrawal Guide, by Darcy Baston, founder of the Paxil Progress website: Almost a year after the CSM/MHRA warning against the use of paroxetine for childhood depression, the European Medicines Evaluation Agency (CPMP) offers an opinion which comes to the same conclusion. A question & Answer document applies much oil to the lock of the stable door. |
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| March 2004 Richard Brook resigns from the MHRA/CSM ‘independent’ review of SSRI antidepressants. He is director of MIND, the cornerstone of the UK major network of users of mental health services. He was the only independent user representative on the review panel. He had resigned, finding no support for his efforts to get important drug safety data published. In the event, the MHRA/CSM rushed out a painfully oblique resume of the problem on the day before Brook resigned. The MHRA/CSM media relations people dressed up the new warning as a "reminder" to prescribers – of advice about paroxetine that they claimed to have given over a decade earlier, when paroxetine first appeared. By means of this ‘reminder’, prescribers were informed effectively for the first time that paroxetine was apparently not effective in depression, above the 20mg recommended starting dose, but that adverse effects increased. The MHRA left it to the CSM to fail to explain why they had licensed a 30mg dosage form of the drug. See two Sarah Boseley reports in The Guardian [1] and [2] In this statement, the CSM/MHRA also mentions for the first time, the risk that sudden changes of dose – up as well as down - may be hazardous. They were advised of this risk 9 months earlier. See Medicines out of Control? page 207.The FDA puts out a Public Health Advisory on Antidepressant Use in Children, Adolescents, and Adults. It is a well-skewed statement, avoiding admission of liability, but recommending that both child and adult users of SSRIs should be closely observed "for worsening depression or the emergence of suicidality when treated with these agents". See also AHRP commentary. Medicines out of Control? is published on 16th March. It is in part a narrative, evidence-based account of the now looming antidepressant drug crisis. It is also a grand tour of the medicines control system that played a major part in causing this crisis to happen. The drug control authorities themselves played a key role in the making of this crisis, and then spent several years making it worse. It cannot make sense now to allow these authorities, working essentially in secret, to investigate their own mistakes. That is what is in prospect when the MHRA/CSM produces its final report on SSRIs in the Summer of 2004.It is already clear that nothing much will be achieved by tinkering with the present medicines’ control system. It needs to be recast and transformed. Lack of public accountability in the medicines control system is a major deficit, and symbolised by the continuing leadership of Professor Sir Alasdair Breckenridge, Executive Chairman of the MHRA. Paul Flynn MP tables an Early Day Motion: "That this House hails the publication of the book 'Medicines Out of Control' as a remarkable account of history repeating itself over the last 150 years in the promotion on anti-depression drugs: congratulates Charles Medawar and Anita Hardon for revealing mountainous evidence of incompetence and inaction by regulatory authorities and profit driven pharmaceutical giants in advocating the use of cocaine, bromides, barbiturates, benzodiazepines and antidepressants as safe drugs until use by millions of patients have proved them to be addictive, dangerous and of little or no utility: regrets that more than six million people in Britain and ten million children in the USA are currently using anti-depressants in spite of mounting evidence that they have been vastly over-prescribed for the mild depression that is an inevitable part of the human experience."A survey of 250 GPs suggests that 80% of GPs believe they are over-prescribing SSRIs, essentially because of the lack of other forms of help under the NHS. |
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| February 2004 Meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to discuss reports of suicidal ideation and suicide attempts in clinical trials for various anti-depressant drugs in pediatric patients with major depressive disorder (MDD). A second meeting on this topic is to be scheduled by summer 2004.See reports from AHRP and CDER and FDA. See also report claiming that FDA medical reviewer, Dr Andrew Mosholder, was barred from this meeting, where he had been expected to present evidence of some increased risks of suicidal behaviour for children using SSRIs for depression. Ten US Senators make enquiries to the FDA about this and related issues. See At the same time, a US Congressional Committee sent identical letters to 4 drug manufacturers "seeking data and background information on unpublished clinical trials involving depressed children." Student, Traci Johnson, commits suicide in a healthy volunteer study involving the Eli Lilly drug, duloxetine (Medicines out of Control? page 90). The Coroner did not investigate the possibility that the drug was implicated, reportedly because, under Indiana state law, "the coroner's office is not allowed to identify any drugs that might have been in Johnson's system because they did not cause the death by hanging".Herxheimer A, Mintzes B, Antidepressants and adverse effects in young patients: uncovering the evidence CMAJ , February 17, 2004; 170 (4). |
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| January 2004 The former chairman of the Committee on Safety of Medicines (CSM), and present Executive Chairman of the Medicines and Healthcare products Regulatory Agency (MHRA) receives a knighthood. Professor Alasdair Breckenridge, a central figure in the development of the antidepressant crisis, "was recognised for his role in ensuring British patients receive safe medical treatment". Breckenridge’s "difficult position" - arising from his close ties with the manufacturers of Seroxat/Paxil/Aropax – is discussed in Medicines out of Control? p. 212. See also: questions of resignation (March 2004) The American College of Neuropsychopharmacology (ACNP) produces an "Executive Summary" of a "Task Force" report, proclaiming the safety and effectiveness of SSRI antidepressants in childhood depression. Eight of the ten Task Force members, including the chairman and co-chairman, disclose close links with GlaxoSmithKline and other SSRI manufacturers. Three members had conducted company-sponsored clinical trials on SSRIs, firmly recommending them for childhood depression. This ANCP Task Force produced this summary of a preliminary report based on limited evidence. Unlike the US and UK regulators, "… the Task Force did not have access to a substantial amount of unpublished data …" This did not inhibit them from making sweeping assertions that the regulators either already had rejected, or soon would. The main headlines the Executive Summary published were, "Several SSRIs are Effective for Treating Youth Depression" and "No significant Increase in Suicidal Behaviour in Clinical Trials of Youth"What makes this seem all the more discreditable is the way in which the ANCP report was disseminated and promoted. It was launched not in a peer-reviewed journal, but at a press briefing carefully orchestrated by a Washington DC-based public relations agency. This agency’s website (GYMR.com), conveys the tone: "Whether it's provoking action on a national health issue or crafting an organizational image that appeals to internal and external audiences, GYMR excels at designing and implementing issue and image campaigns." "Our media events are successful because we have a nose for news. We know how to take the language of science and medicine and transform it into the more understandable language of health. We advise clients of the best dissemination strategy for their news and make sure that the message they deliver is compelling, documented and contributes to other national dialogues in a real and meaningful way." "At GYMR, we deliver timeless and timely events that forge a lasting impact. Whether it is a serious policy-based conference, Capitol Hill event or gliterring (sic) consumer promotion, we create events for our clients that are creative, strategic and memorable." These may not be idle boasts. Following the launch of the ACNP report, the headlines generated even in the professional press spake thus: "New report concludes SSRI antidepressants do not increase suicidal behaviour in Youth with depression"; "Group finds no Suicide-Antidepressant Link"; "SSRI, suicide link called weak". |
