5.1 What was New? (Scroll-down editorial notes, 1998-2003)
Click here for: What's New? from January 2004
20040316 Medicines out of Control? Antidepressants and the Conspiracy of Goodwill was published in March 2004. By this time, nearly seven years after Social Audit first alerted the authorities, the UK, EU and US governments had all separately begun to investigate what had gone wrong; their findings are due around summer 2004. The immediate problem is that some people feel worse on antidepressants - mainly because of weight gain, loss of libido, sensory disturbances and mood swings, at times to the extent of feeling suicidal. Yet when people try to stop taking these drugs, they often find they cant: the withdrawal symptoms are too severe.
Medicines out of Control? provides a template for interpreting the impending verdicts of these forthcoming government enquiries, and confidently anticipates their inadequacy. Both by default and design, the problems antidepressant users now face are largely of the making of the present systems of medicines control. The nature and magnitude of these problems signals the urgent need to inject pharmaceutical medicine with a dose of democracy, and to subdue commercial pressures in the interests of health.
20031120 Our analysis of over 1,500 anonymised 'Yellow Card' reports of suspected adverse reactions (ADRs) to paroxetine has just been published in the International Journal of Risk & Safety in Medicine (Medawar & Herxheimer, 2003). It is the first review of its kind, but could be the last. The analysis relates to withdrawal and dependence problems and drug-induced thoughts and acts of violence and self-harm - and therefore complements our previous review of user reports, for the Panorama programme, Seroxat: Emails from the edge (BBC-TV, May 2003)
This new analysis reveals a medicines control system that is, in important respects, "chaotic and misconceived". It suggests that a combination of factors has led to a dangerous under-estimation of the risks of SSRIs. Most Yellow Cards lacked important information: reports were typically so brief as to demand effective follow-up, especially in the course of formal reviews. Our report shows that the Medicines and Healthcare products Regulatory Agency (MHRA) systematically failed to follow up reports of suicidal behaviour as a possibly drug-induced effect. The combination of poor reporting, flawed data processing, uncritical interpretation and lack of follow-up has had a devastating effect on perceptions and understandings of drug benefit and risk.
The UK adverse drug reaction reporting scheme is now being reviewed, and the review team has invited written responses to its questions. We recently gave oral evidence to the Review and submitted a note - further discussing our Yellow Card analysis.
20030808 Here is the written evidence from Dr Andrew Herxheimer and Charles Medawar to the CSM working group on the safety of SSRI antidepressants. In oral evidence, we mentioned new possible risks with SSRIs and asked that urgent consideration be given to the need for interim guidance for doctors and users.
Meanwhile, what started as a side show no longer is: see continuing correspondence with the Department of Health press office. An editorial note on Information Management, Conflicts of Interest and the safety of SSRIs has more to say about the DoH/MHRA news management style. It also explains the significance of an important review of Yellow Cards (suspected adverse drug reaction reports) that has so far escaped significant media attention.
Antidepressant prescribing/consumption has almost trebled in the past decade. See data
Welcome to a new, independent website covering SSRI-related issues mainly in Germany, the USA and UK. Willkommen zur Homepage des Antidepressiva-Forums Deutchland
20030716 Dr David Healy recently gave written and oral evidence to the on-going enquiry into the safety of SSRI antidepressants. Here are his two written submissions - briefing papers on withdrawal/dependence and on suicidal behaviour - plus follow up letter to the chair of the review.
This evening, Healy proposes the motion - 'this house believes that antidepressants cause dependence' - in a debate at The Maudsley (the Institute of Psychiatry at King's College, London). Charles Medawar is seconding the motion: his note on The Maudsley Debate summarises much of what he expects not to be able to say.
20030611 This update is pure side-show: more trivial but telling stuff. This continuing correspondence with the Department of Health further illustrates the triumph of official process and bureauracy, and the compulsion to obey orders, over any impulse to seeking after truth or health. 20030610 The UK Department of Health today hosted a press briefing, where they made an important statement about the safety of paroxetine (Seroxat/Paxil/Aropax etc) and other SSRIs. See www.mhra.gov.uk The DoH statement raises as many questions as it answers, but surely the end game has begun. As if to underline how much more there is to be said about problems with SSRIs and the inadequacy of drug regulation, the DoH failed to invite Panorama to the briefing and refused Social Audit leave to attend. Trivial but telling stuff. Watch this space. 20030509 Not to be missed: Panoramas follow up programme "Seroxat: E-mails from the Edge" - will be broadcast on Sunday, 11 May 2003 at 22:15 BST on BBC-1 TV. 20030312 Social Audit is now seeking a referral to the Ombudsman, to complain about the conduct of the MCA/CSM "intensive review" of the safety of SSRIs, notably paroxetine. How can the government reconcile the appointment of a review team with so many conflicts of interest, while refusing access to Social Audit? Further correspondence with the MCA relates to its response to the Panorama programme (Secrets of Seroxat); to the "electric head" phenomenon as a symptom of SSRI withdrawal; and the on-going "intensive review." Three months on, the MCA eventually replied to Social Audit's questions about the extent of secrecy and conflicts of interest that surround its attempts at drug advertising control. The present state of play is all the more dismal in view of the MCA's current proposals to allow promotion of certain OTC products as antidepressants.
See also the Public Citizen (Health Research Group) petition to remove nefazodone (Serzone) from the US market.
The Prescription Medicines Code of Practice Authority is about to publish its findings on Social Audit's complaint about GlaxoSmithKline's promotion of paroxetine. Though the complaint was upheld, the ruling did not address questions relating to GSK's responsibilities (as opposed to the conduct one of its employees). A new complaint has therefore been submitted to ask for an adjudication on the matters outstanding from the last case.
20021203 The Medicines Control Agency refused Social Audit access to its 21 November consultative meeting with the Committee on Safety of Medicines, on withdrawal problems with SSRIs. The MCA/CSM has also written in defence of its statement on the BBC Panorama programme. The upshot is that Social Audit is preparing yet another formal complaint.
The MCA is now consulting on a proposal to end the prohibition on advertising of over-the-counter (OTC) medicines for a number of serious illnesses, including "psychiatric diseases." The merits of this proposal are obscure but without transparency and effectiveness in the advertising control system, they would seem absurd.
See also: important new report on neonatal withdrawal syndrome: of 55 neonates exposed to paroxetine in the last trimester of pregnancy, 12 had complications requiring intensive care and prolonged hospitalisation.
20021012 GlaxoSmithKline, has been ruled in breach of the UK pharmaceutical industrys own code of marketing practice for misleading promotion of paroxetine. This product, (Seroxat in the UK; Paxil in the USA etc) is the subject of a major BBC-TV documentary (Panorama), to be shown on Sunday, 13 October 2002. READ ON
Continuing correspondence with the Medicines Control Agency raises a number of questions relating both to the BBC-TV Panorama programme and to the code of practice ruling by the Prescription Medicines Code of Practice Authority.
Antidepressant prescribing/consumption data (1991 - 2001) updated
20020809 Social Audit's second complaint to the Prescription Medicines Code of Practice Authority about GlaxoSmithKline's claims for Seroxat (paroxetine) has been rejected, on the grounds that it was not possible to determine precisely what the company's spokesman had said. We have lodged an appeal, which is likely to be heard in October. See letter on matters arising to the Medicines Control Agency. A further letter to the MCA discusses the interpretation of Yellow Card reports of suspected withdrawal reactions to paroxetine, venlafaxine and other drugs. The MCA's Guidance notes hint at all kinds of reasons for doubting the significance of these reports, but do they have any real meaning at all? See also the attachment to this letter: a selection of SSRI users' comments on experiences with doctors 20020721 The Medicines Control Agency has agreed to consult the Committee on Safety of Medicines about patients' reports of paroxetine (Seroxat) withdrawal/dependence problems. The MCA has also supplied a list of the top 20 drugs for which withdrawal problems have been reported under the UK's "Yellow Card" scheme for reporting suspected adverse drug reactions. Five of the top six drugs are SSRI or related antidepressants. Paroxetine alone has attracted more such reports than all other drugs on the UK adverse drug reaction database combined - meanwhile, the Seroxat Patient Information Leaflet insists that withdrawal symptoms "are not common and (they) are not a sign of addiction". Paroxetine users who know better might like to draw to the attention of prescribers the DEAR DOCTOR letter attached. 20020703 After a break of 18 months, Social Audit has re-opened correspondence with the Medicines Control Agency. During this time the MCA and Committee on Safety of Medicines appear to have done nothing to check problems relating to dependence/withdrawal problems with SSRIs. This letter asks why not, and why GlaxoSmithKline should still feel at liberty to claim - with official approval - that dependence on paroxetine (Seroxat/Paxil/Aropax etc) isn't a problem. See just a few of the comments from users that says it is. The response from the MCA is now well overdue.
Social Audit is also awaiting resolution of a second complaint, relating to essentially the same problem, filed in May with the industry's self regulatory body, the Prescription Medicines Code of Practice Authority.
Meanwhile, a US law firm is seeking an injunction before a Federal Court in Los Angeles, seeking to stop GSK from claiming in Direct-To-Consumer TV and press advertisements that Paxil is not habit forming or associated with dependence. The hearing on the preliminary injunction is due later this month or perhaps next.
20020422 See further correspondence (November 2001 to April 2002) between Dr David Healy and the Medicines Control Agency and Department of Health, detailing concerns relating both to dependence on SSRIs and risk of aggressive and suicidal feelings. Several new references added to website bibliography and Table of published reports relating to withdrawal/dependence problems with SSRI - including new reports relating to withdrawal phenomena in newborn infants (after exposure to SSRIs in pregnancy) 20020212 The IFPMA has endorsed the findings of PMCOPA, upholding Social Audit's complaints against GlaxoSmithKline (re: Paxil, paroxetine). Complaints upheld ... but insipid reading to be sure. See also press reports in The Guardian (23 January) and The Observer (3 February) 20020118 Late last year, the pharmaceutical industry's self-regulatory machine finally heard the complaint about GlaxoSmith Kline (GSK) made by Social Audit to the IFPMA, over a year ago. After considering GSK's preliminary submission, the UK's Prescription Medicines Code of Practice Authority (PMCOPA) invited GSK to appear at an Appeal hearing to defend itself against charges of "substantial and serious failure" to provide Paxil (paroxetine) users with information that was accurate, fair and not misleading. What did the company do when accused of persistently unreasonable, improper and unwarranted behaviour? It tried to get the Appeal postponed - and when that failed, it refused to appear. GSK was duly found in breach of the Code, in November 2001. The Company lost the Appeal; publication of findings by PMCOPA and IFPMA is now imminent.
Then, just before Christmas (and just in time to miss the 2002 edition of the Physicians' Desk Reference) - GlaxoSmithKline (US) published an important new label change for Paxil - a grudging acknowledgement that withdrawal problems have been frequent in clinical trials. All this time, GSK has been insisting that paroxetine withdrawal problems were rare and mild - even to the extent of trying to pull the wool over the eyes of its own trade association. More to come.
20011210 "Remember that you cannot become addicted to Seroxat" . "These tablets are not addictive" ... Withdrawal symptoms "are not common and they are not a sign of addiction". These claims from the manufacturers of Seroxat (paroxetine - GlaxoSmithKline [GSK]) are legally approved in the UK thanks to the MCA/CSM, with active encouragement from the Royal College of Psychiatrists (RCPsych). New evidence, soon to be published on this website, underlines that these claims are unfounded and misleading. Paroxetine is notorious for causing withdrawal problems (UMC/WHO, 2001) and on any sensible, straightforward definition, it is a drug of dependence (WHO, 1998). The simplest definition of drug dependence given by WHO is "a need for repeated doses of the drug to feel good or avoid feeling bad". What could be clearer than that?
Meanwhile, GSK has also been very influential in pushing the European Commission into relaxing the laws which make Direct-To-Consumer (DTC) promotion illegal, for prescription- only drugs. The Commissions proposals are soon to be considered by the European Parliament and SOCIAL AUDIT has prepared a briefing prepared for them: Direct-To-Consumer promotion.
This briefing does not mention that the top-spending DTC drug advertiser in the US is GlaxoSmithKline, manufacturers of Paxil (paroxetine). Last year, GSK spent US$92 million, just on Paxil advertising, in journals and on TV. Current adverts say: "Talk to your doctor about non habit-forming Paxil today"
This briefing to MEPs is not only a plea to maintain the present prohibition on drug advertising. It is also an attempt to explain why standards of honesty, integrity and public participation are so low and sinking. How can a drug of dependence also be promoted as "non habit-forming"? Its to do with economics more than science and down to climates, winds and tides. Read on.
20010914 Legal action has begun in the USA against the manufacturers of Paxil/Seroxat (paroxetine), on behalf of a number of people who have experienced severe withdrawal reactions, and similar action is expected soon in the UK and elsewhere. See: A suitable case for litigation? Partly to underline the key role he has played in calling the manufacturers of SSRIs to account, we now publish a collection of 30 letters exchanged between Dr David Healy and the MCA, 1999-2001. One year has passed since SmithKlineBeecham refused to substantiate sweeping claims made on US-nationwide TV about the safety of paroxetine but at last the IFPMA appears to be investigating Social Audit's complaint. See also updated SSRI consumption data (England only), and several new additions to the table of SSRI withdrawal/dependence reactions 20010620 The important revelation that SmithKline Beecham found in the 1980s that many healthy volunteers experienced withdrawal symptoms with paroxetine is briefly discussed in an editorial: DEPENDENCE RULES, OK? Finally, the MCA gets round to enforcing advertising standards for Detrusitol that the US FDA picked up on three years ago. Meanwhile, the credibility of the IFPMA's Code of Practice barely hangs in the balance. 20010413 Editorial: Integrity in drug promotion - continuing saga about the withdrawal/dependence risks with paroxetine, involving both the manufacturers and the IFPMA. An editorial on European perspectives on withdrawal and dependence risks with SSRIs focuses on strange new proposals from the EMEA and CPMP. Both editorials refer to a printout from the WHO-Uppsala Monitoring Centre identifying the SRRI and other drugs for which most reports have been received - one of the dozen new papers/reports that have been added to our main table of SSRI withdrawal/dependence reactions. Contact with the MCA has been minimal since publication of a critical report by the Ombudsman; meanwhile, the Agency's investigation of Detrusitol advertising drags on and on. 20010101 Abortive requests for evidence about the safety of paroxetine (Paxil/Seroxat) addressed to SmithKlineBeecham have prompted an enquiry to the International Federation of Pharmaceutical Manufacturers Associations (IFMPA). Several letters have been received from the MCA over the past quarter: they deal with complaints about advertisement for Seroxat/Paxil and Efexor/Effexor and refusal to supply basic information about the Agency's handling of advertising complaints. Following a complaint to the Ombudsman, the MCA has sent a heavily censored copy of the Assessment report on Detrusitol: see Social Audit reply. Immediately before Christmas, the MCA also sent a censored version of the Medicines Commission/Medicines Control Agency discussion document on Direct To Consumer Advertising, requested about a year ago. See also updated SSRI consumption data (England only) 20000906 COSTLY BENEFITS AND THE CONSPIRACY OF GOODWILL - paper given by Charles Medawar at the annual meeting of the British Association for the Advancement of Science. Meanwhile, the MCA replies to earlier queries about direct to consumer advertising. See also transcript of ABC-TV '20-20' program on SSRI withdrawal, noting SmithKline Beecham's assertion that, when paroxetine is "discontinued appropriately", withdrawal symptoms are rare, short-lived and mild. Enquiries to SKB will be pursued. 20000806 The Ombudsman has decided to investigate the complaint referred by Richard Shepherd MP, that the MCA failed to respond adequately to requests for information about its thoughts on DTCA - though outstanding questions remain about the scope of the Ombudsman's review. This appears to have concentrated minds, leading to much tooing and froing with the MCA, including a response to the complaint about advertising of Citalopram (Cipramil/Celexa) and (after a six month delay) information about the MCA's work in drug advertising control. See also Social Audit's submission to the European Commission on Direct to Consumer Advertising (DTCA) 20000720 Blame this belated update partly on the MCA. The delays are getting worse, compounding the "poverty of spirit and meanness of mind" that seems to characterise the Agency's policies on disclosure. Finally, in response to a formal complaint, the MCA did come up with some information about their (barely developed) thoughts on Direct To Consumer Advertising (DTCA). It was nothing like sufficient, and has led to a referral to Richard Shepherd MP who has passed it on to the Ombudsman. The MCA has also responded to Social Audit's complaint about advertising for Seroxat. This is an issue we shall pursue - not because of the somewhat piddling claims, but because MCA seems off balance, barely able to control advertising standards. Look at the delays in responding to complaints about adverts for Efexor XL, Cipramil and Detrusitol 20000524 Watch this space: http://abcnews.go.com/sections/living/DailyNews/ssri000524.html This ABC-TV 20-20 program discussed the relationship between fluoxetine (Prozac) and suicidal thinking and actions. A second broadcast (25 August) discussed problems of dependence and withdrawal from SSRIs. See http://abcnews.go.com/onair/2020/2020_000825_SSRIwithdrawal_feature.html 20000515 Hugely uninformative reply from the Medicines Control Agency (MCA), re promotion of prescription-only drugs to the public (DTCA), provokes a long response from Social Audit: "I fear it may irk you to see all these questions, not to mention the forthcoming request for yet another internal MCA review, but I think you will also understand that I have no alternative but to ask. Any time anyone from the MCA wants to discuss matters intelligibly, they have only to pick up the telephone. I've been waiting for nearly three years and am quite prepared to wait another three, relying in the meantime on your considerable patience, appetite for process, and gift for meticulous imprecision." See also MCA response to queries about US and UK prescribing information for citalopram (Cipramil/Celexa). 20000417 Two years on, the European Medicines Control Agency reports on meticulous examination of door through which horse has long since bolted. This is Europe at its most hopeless - lowest common denominator stuff - but good for them for rejecting the term "discontinuation reactions", anyway. Meanwhile, a new book, Prozac Backlash, points emphatically in the direction the horse got away; Lilly much displeased. See also the Medicines Control Agency 'response' on the question of fluoxetine dosage - head held high, as ever; egg all over its blinkers, yet again. 20000402 Can the Medicines Control Agency be relied on to control advertising standards? Social Audit is banging away at this question not just because claims for antidepressants are involved; it's because of the threat of direct to consumer advertising (DTCA) in Europe and beyond. No hope for health if claims are not tightly controlled - hence this letter:
"... This is the fourth occasion in the last few months on which I have referred an advertisement to the MCA when the same important point of principle seems to arise. To what extent is it permissible to make bold headline claims for none too gentle drugs, on the basis of rather tentative small-print findings? Is it reasonable (and likely to encourage rational prescribing) to make sweeping generalisations on the basis of relatively isolated observations, when these would be of little or no real benefit to the vast majority of people exposed to the drug? ... The claim in question here is that paroxetine 'Lifts mood quicker than fluoxetine'."
The manufacturers of paroxetine (SmithKline Beecham - Seroxat/Paxil) relied on two studies to support this claim. Neither seems to justify the sweeping and unqualified assertions about the superiority of paroxetine - especially not the second study, which is notable mainly for some remarkable new data relating to adverse effects including Emergent Anxiety. "Here the authors describe what they found when looking very closely for evidence of symptoms of anxiety that showed up only after starting drug treatment - the implication being that the anxiety resulted from the drug treatment itself. It makes pretty alarming reading."
Meanwhile, there is precious little evidence that the MCA has given much thought to the implications of DTCA, and there's another round in the Detrusitol saga. See also an interesting letter (Diller, 2000) with revealing IMS Health statistics on psychiatric drug use by children in the USA: " ... between 1995 and 1999 ... the use of Prozac-like drugs for children under 18 is up 74 percent; in the 7-12 age group it's up 151 percent; for kids 6 and under it's up a surprising 580 percent. For children under 18, the use of mood stabilizers other than lithium is up 40-fold, or 4,000 percent and the use of new antipsychotic medications such as Risperdal has grown nearly 300 percent."
20000320 Several new developments are discussed in an editorial note: ANTIDEPRESSANTS, ADVERTISING AND WRITING ON THE WALL. Three months on, the Medicines Control Agency says it is satisfied that advertisements for Efexor XL (venlafaxine) comply with the regulations; Social Audit suggests they think again. Meanwhile, Eli Lilly has announced it is seeking approval for a once-weekly version of Prozac (fluoxetine) - and the MCA will shortly complete an internal review relating to our enquiries about a low-dose version of that drug. 20000301 The Medicines Control Agency professes deep lack of concern about the marking of Prozac (fluoxetine) in the UK in a 'one-size-fits-all' dosage form - but could it be that Eli Lilly has introduced the lower dosage formulation in the USA with a view to marketing Prozac for children? The US Food & Drug Administration (FDA) is actively considering the possibility of licensing antidepressants for children, though a recent JAMA report indicates they are already quite widely used even by pre-schoolers, two to four years old.
Meanwhile, the MCA is asked to explain its view that Pharmacia & Upjohn's advertising of Detrusitol is merely "potentially misleading", when the FDA has reported repeated violations by the company - indeed, how many GPs would realise that claims about the selectively of this drug were based not on trials in humans, but on studies in cats? Further correspondence with the Prescription Medicines Code of Practice Authority just touches on this. See also: end of thread correspondence with Claire Rayner about direct-to-consumer advertising - plus a communiqué from Mrs Leakey (on paper sourcing by the MCA and other matters), and a coda about rubber stamps as well.
20000201 Further correspondence with the Medicines Control Agency about advertising of Detrusitol and other matters. Yes, this website is primarily about antidepressants, but this departure - looking at advertising for drug treatments for urinary incontinence, and DTC advertising - is throwing up some important generic issues about the quality and tone of drug regulation in the UK and EU. See also continuing correspondence with Claire Rayner and Patients Association. 20000122 Social Audit's formal complaint about the advertising of Detrusitol has been upheld. This was the product that launched the UK's first ever Direct-To-Consumer Advertising for prescription-only drugs on TV. See further correspondence with Claire Rayner, President of Patients Association - and further complaints to the Medicines Control Agency, about advertisements for Efexor/Effexor (venlafaxine) and Cipramil/Celexa (citalopram). Meanwhile, the MCA continues to play for time: enquiries about the dosage of fluoxetine (Prozac) remain outstanding, and Mr Alder has yet to respond to complaints about Detrusitol and enquiries about the effectiveness of advertising control by the MCA. Partly by way of encouraging the MCA to do better, some detailed enquiries have been made about the quality of UK prescribing information for Cipramil (citalopram). Looks pretty awful, but how typical is it?
See also extensive updating of the table summarising reports of withdrawal reactions to SSRIs, including two reports detailing reactions that have persisted long after drug discontinuation - plus two other interesting reports, touching on possible sensitisation by antidepressants and the nature of dependence (as it was then called) on them after long term use.
Other bits and pieces include an enquiry to the European Commission - said to be examining reports of physiological dependency on SSRIs in animals - and further, unsatisfying exchanges with the department of mental health of the WHO.
19991123 Essay - Re: PROZAC - DOSAGE, AKATHISIA AND FAILURES TO WARN. Plus continuing corrrespondence with Claire Rayner: where does the Patients' Association stand on direct-to-consumer advertising? See also: letter from WHO withdrawing their very low published estimate of the extent of tranquilliser dependence, plus more on potential conflicts of interest - a new Mother Jones report on pharmaceutical industry funding ($11.7m between 1996 and mid-1999) of a US "grassroots" mental health organisation. 19991103 Note about a new paper: "Do antidepressants have any potential to cause addiction?". Another enquiry to the Mental Health Division of WHO, this time about their low estimates of the extent of (benzodiazepine) tranquilliser dependence. Link to an important report in The Guardian (30 October), based on Dr. David Healy's new analysis of the risk of suicide with Prozac. Plus SSRI consumption data (England only) for 1998, and a belated and rather empty reponse to queries about clinical trials from the MCA.
PLUS: more on DTC advertising, arising from the King's Fund debate, including transcript of remarks by the proposer, and letter to Claire Rayer, President of the Patients Association (a prominent figure in the debate), and complaints under the industry's advertising code and to the MCA. The complaints are about a professional advertisment in the current BMJ for the anti-incontinence drug whose manufacturers sponsored the UK's first DTC advert on TV.
19991017 Lots going on, but top of the list is a short report on "Direct-to-Consumer Advertising" - comment on the impending threat of TV and press advertising for prescription drugs, including new, alarming information about conflicts of interest in promoting antidepressant drugs. Big questions loom. 19990924 The Ombudsman has upheld the complaint made by Richard Shepherd MP on behalf of Social Audit, and the MCA has now supplied the information requested about declared conflicts of interest in the CSM. The Permanent Secretary at the Department of Health has also apologised for the delay. Social Audit's response to him summarises the problems that remain on other fronts, referring also to a telling report from the Chief Pharmacist at the Maudsley Hospital, London, about the problems of bad warnings and the severity of SSRI withdrawal. 19990828 Flannel from the MCA, with reply: "Sometimes, when I read these things, it merely feels like sinking up to my nostrils in porridge, but this one felt like being in the Sahara in a thick woolly jumper and leggings ..." 19990815 Further requests to the MCA for information about clinical trials, and about secrecy in the Committee on Safety of Medicines: "It is not immediately obvious to me how the CSM can both be exempt from the Code on Access and 'ensure that the Code is adhered to'. What's 'fully consistent' about that?" 19990811 More about problems with clinical trials. See also: letter from the Ombudsman to Richard Shepherd MP, re the continuing delay in reporting on the investigation of Social Audit's complaint about secrecy in the Medicines Control Agency. 19990801 MCA shows how to savage a Dead Parrot ...and how not to ... 19990727 Seminal new evidence points to systematic and sometimes fundamental inadequacies in the conduct of clinical trials. In this letter to the Secretary of State for Health, Social Audit asks what the MCA/CSM know about standards of compliance with Good Clinical Practice (GCP) guidelines - and what they propose to do to reduce risks for patients and to eliminate sloppy research practice in clinical trials conducted in the UK and elsewhere. This letter was prompted by the findings of some 800 GCP audits conducted by a relatively small commercial consultancy - but with much more experience in this field than the MCA. Patients considering involvement in clinical trials should be aware of the conclusions of one of the directors of this consultancy, Wendy Bohaychuk PhD: "Our database of GCP compliance assessment basically shows that new GCP guidelines and regulations have not yet improved the situation for patients over the last few years and frankly, after 10 years of detailed auditing, I would never go into a clinical study myself and I would certainly try to discourage anyone in my family from doing so." See also The Guardian, 27 July 1999, pp 2, 8, 17, and Letters to the Editor, on 30 and 31 July and 3 August 1999. 19990721 Letter to the MCA: " ... I tell you what. I'll give you three points for every NO answer you give, and I'll just take one point, for every time you say YES. Here we go ..." 19990719 A suitable case for re-evaluation? Comment on a new Drug & Therapeutics Bulletin review, Withdrawing patients from antidepressants. "True, there is something in this review to please just about everyone - or at least console them - but that is why it misses the mark. By trying not to offend anyone too much, the DTB in effect denies the controversy and problems that surely exist." 19990625 The MCA has finally responded to enquiries dating back to March 1998 - emphasising that the public has no right to know which members of the Committee on Safety of Medicines have affiliations with pharmaceutical companies, and what they contribute to discussions about the drugs those companies make. The MCA has also decided, in future, to post heavily edited copies of the minutes of CSM meetings on its website. Social Audit has acknowledged the MCA/CSM response but analysis of the documents sent will be deferred. The Ombudsman's report is due soon. See also: further comment on the draft FOI Bill 19990614 Letter to Dr Jones at the MCA about the new draft FOI Bill: "... I cannot blame you if you are rubbing your hands with glee, even as I am wringing mine" ... and a response to the acknowledgement sent on his behalf. Also a new information request to Mr Alder 19990607 Two weeks ago, the UK Home Secretary, Jack Straw, introduced the long-awaited Freedom of Information Bill, and tonight he will be speaking about it at the annual awards ceremony of the Campaign for Freedom of Information. Here is Social Audit's response to the proposals so far made - an opportunity also to focus on the abysmal record on disclosure of the Medicines Control Agency and the Committee on Safety of Medicines. 19990521 As HM Government prepares to publish its long overdue Freedom of Information Bill (on 24 May), the Medicines Control Agency and the Committee on Safety of Medicines continue their farcical resistance to disclosure. Now the Office of the PCA writes to the Permanent Secretary at the Department of Health. 19990407 The Editor-in-Chief of Addiction recently commissioned an editorial, DO ANTIDEPRESSANTS CAUSE DEPENDENCE? but then decided not to publish it. Here he explains why not, and reveals the expert advice he received that persuaded him not to act. Plus more of the same from Messrs Alder & Dunlevy at the MCA. 19990318 "... I think the reason the CSM/MCA are so secretive about the long-term risks of antidepressants etc is that they're paralysed by disagreement, and torn by the conflict of interest - between now acknowledging there could be serious risks for patients, and admitting they've made serious mistakes themselves ..." Social Audit responds to still more evidence of the madness of secrecy from the Medicines Control Agency. 19990310 More procrastination from the MCA, some exasperation too ... 19990303 Another little gem from the MCA: the unaimed arrow never misses ... See also Social Audit reply: "If you (MCA/CSM) think there are fundamental flaws in my assessment of the risk - as I am certain there are in yours - I think you have a public duty to say so..." See also continuing Discussion: "What is a true and fair view?" 19990222 The MCA rejects a request for copies of minutes of CSM meetings - and Social Audit asks on what grounds. Meanwhile, Mr Alder proposes the Ides of March as a deadline for completing the MCA review. 19990216 Social Audit letter to Richard Shepherd MP re the Ombudsman's decision to wait for the MCA to complete its "wide ranging and comprehensive review" into all outstanding complaints. "Once the review has been completed, which we understand will be in the very near future, we shall issue the Ombudsman's report." 19990208 Social Audit reply to Mr Alder at the MCA: " ... I am afraid there is no way I can respond to your letter of 28 January both clearly and as tactfully as I would want. Forgive me if I err on the side of clarity ..." 19990202 As its 'review' of the risk of dependence with SSRIs enters its second incredible year, the MCA continues to paddle HMS Colander furiously up the proverbial creek. The promise of open, accountable government gives way to patronising twaddle ... 19990122 "very much regret ... taking considerably longer ... as soon as possible ... sincere apologies ..." etc etc from the Medicines Control Agency 19990114 Several more exchanges with MGH - but now becoming indigestible. 19990111 More BEYOND THE ABSTRACT, about corporate sponsorship and possible conflicts of interest: "I mention the World Psychiatric Association mainly to make some wider point about the close linkage between pharmaceutical companies and World Health Organisation. Very simply, the model I have in mind involves companies pumping money into the WPA and its constituent organisations, and the WPA pumping influence into WHO..." 19990107 Reply to Drs Rosenbaum & Fava at Massachusetts General Hospital: "In short, I believe your comments substantially reinforce the thrust of my argument, if not my apparent credibility as a researcher of finer points. Perhaps you would like to reconsider your position?" 19981229 On the brink of Christmas, the MCA finally released 80 pages of "confidential" documents, detailing the enquiries made, through March 1998, into the risks discussed in The Antidepressant Web. See also Social Audit reply. Though far from complete, this disclosure richly adds to understanding about: the abuse of secrecy in government; the nature of drug safety investigation; the quality of risk assessment; the influence of drug manufacturers on the regulatory process; and the risk of dependence on SSRIs and other antidepressants. See TALKING COLD TURKEY - notes for a draft review. 19981218 Detailed response from Massachusetts General Hospital and preliminary reply. Notes from a recent talk on sponsorship by the pharmaceutical industry. 19981215 Delving further BEYOND THE ABSTRACT, see enquiry to Massachusetts General Hospital. Under pressure from the Ombudsman, the MCA (Mr Alder) is slouching towards disclosure - presumably hanging on for Christmas Day. Meanwhile, Dr Jones' eyebrows remain immobilised: more face-saving stuff on problems with neurolepic withdrawal. 19981205 Part six of BEYOND THE ABSTRACT: " ... this feels to me like something that is going to run and run. Apart from providing (albeit inadvertently) what I can only interpret as solid evidence of the risk of dependence with SSRIs, the papers reviewed raise many questions about the conduct of business, medicine, science and public life ..." Other letters from DoH and MCA 19981202 Part five of BEYOND THE ABSTRACT: " ... the long-term efficacy of antidepressants over placebo seems an illusion. It has been inferred from trials in which the investigators have not doubted that depression following drug discontinuation invariably points not to withdrawal symptoms, but relapse." 19981127 The fourth instalment of BEYOND THE ABSTRACT points to the most compelling evidence on this website of the magnitude of the dependence risk with SSRIs, by graphically illustrating both how it is hidden and how it is revealed. 19981125 The third instalment of BEYOND THE ABSTRACT begins to focus on withdrawal from fluoxetine. Plus: letter from Dr Jones (MCA) about Ritalin and neurolepic withdrawal, with meaningful reply. 19981123 Second instalment of BEYOND THE ABSTRACT: Here is reliable data about the effects of withdrawal from either paroxetine or sertraline: it as good as confirms that the MCA/CSM have underestimated the risk of withdrawal symptoms by something like 100,000% - a gross misinterpretation of data from 'Yellow Card' spontaneous adverse reaction reports. Also: letters to Mr Alder about indemnity provided for CSM members, and a first anniversary request to Dr Jones (MCA) to now withdraw or correct the study by Price et al (1996). 19981120 This is the first instalment of a rambling review, BEYOND THE ABSTRACT. It focuses on a recent Lilly-sponsored, clinical trial report that describes what happens when people stop taking fluoxetine, paroxetine and sertraline. This preamble describes wheels within wheels, within the worlds of corporate sponsorship and academic authorship. Scary stuff. 19981117 An MCA internal review has concluded that the Agency should disclose information about its 26 March meeting with the CSM, to discuss SSRIs. The MCA has accepted this finding and is now considering "what, if any, information might be released". Social Audit reply discusses also the implications of Prof Rawlins' departure from the CSM in six weeks' time. 19981113 Letter from Mr Alder (MCA) about relations with the CSM, and Social Audit reply: " ... to insinuate that I am a slouch on disclosure compared with many members of the CSM, might have seemed highly defammatory had it not first blown my mind ..." Plus: brief note about this thought from the Royal Society of Medicine: "'Antidepressants should be available on request' - even if you aren't ill" 19981109 Heavy letter about a BMJ review of iatrogenic illness, and preliminary response from Social Audit: "The underlying problem has to be over-reliance on pharmacovigilance to an extent that values the meticulous analysis of lack of evidence over and above good common sense ..." Brief letter from Prof Rawlins (CSM) and weary reply. 19981103 Editorial Notes: 1. Cochrane Collaboration and the BMJ; 2. A good move by Glaxo Wellcome; 3. Much ado about Prozac. Meanwhile, the Ombudsman has now told Richard Shepherd MP that he will investigate Social Audit's complaint against the MCA. 19981027 Some 30 million prescriptions are written in England each year for drug products designated "less suitable for prescribing", costing the NHS over £100m/year. See Tabulation and letters to the Health Secretary, Health Select Committee and Joint Formulary Committee. 19981021 Prescriptions for Ritalin (for hyperactive children) have increased 15-fold in the past 4 years. Dr Jones (MCA) acknowledges "an increasing trend" in prescribing but suggests there is no cause for concern - but what is the view of the CSM? Also: letter from Mr Dunlevy (MCA) and Social Audit reply re: risk evaluation for antidepressants. 19981019 Housekeeping mainly: holding response from MCA (Mr Alder) and a further enquiry from Social Audit. Still chasing information about the extent of drug-induced iatrogenic illness in NHS hospitals. 19981014 Re: attendance at a meeting in Geneva between voluntary sector groups associated with Health Action International and senior executives in the new WHO administration. This was not directly related to antidepressant drug safety: WHO's Mental Health Division did not pursue its proposal for a meeting. 19981012 Letter from Social Audit to MCA (Mr Alder) re: complaint to the PCA. "All this time, we have been positively hurdling through your administrative hoops, making the most strenuous efforts to join in the guessing games and satisfy the quaint requirements of bureaucracy. We have endured long delays and silences, carefully crafted obfuscations and wily use of words - and, even now, we are up against the CSM's crushing use of law. Yes we felt we needed the Ombudsman's help and, in the light of what your letter says, it seems we need it all the more ..." 19981008 Letter from the European Commission and reply from Social Audit: confusions abound. Press report about paroxetine for shyness: hype abounds. Many apologies to website visitors for the continuing problems with our new discussion section. Please keep trying: it should be working very soon. 19981005 Letter from Social Audit to MCA Post Licensing Division: what is the evidence they have properly understood and assessed the risks involved with SSRI? Follow up to 19981001. 19981001 : "... My reading of this whole correspondence makes me feel like Chief Deckchair Attendant on RMS Titanic. The combination of bull and guff, with ritual secretion of everything of substance, leads me to think that the Man on the Clapham Omnibus might be very well-advised to jump off at the next stop ..." More from Social Audit to the MCA 19980928 News from the WHO, belatedly received. Social Audit replies to the first of three outstanding letters from the MCA/CSM: "... it occurs to me that we might just be playing this preposterous game of hide-and-seek because the CSM is relying on this appalling piece of law. How else could they credibly claim unchallengable power to say absolutely nothing if they don't want to? Promise me this isn't happening." Letter includes a brief explanation for overseas website visitors of the significance for the CSM of the UK Honours system system, plus a late-posted follow-up to correspondence with Prof Breckenridge, who next year succeeds Professor Rawlins as Chairman of the CSM. 19980926 Website down for four days. Many apologies. Problems with discussion pages should be sorted by 1 October. 19980924 Editorial note & Letter: COMING BACK, CATCHING UP ... Most of this month I have been away, breathing real air. Back at the office, I am now in the midst of inches of paper and kilos of bytes; I am still rolling them all around my mind. I feel like asking What's Up? as well as What's New? 19980828 Editorial note: RELAPSE OR WITHDRAWAL? and questions arising (also re: Ritalin) to CSM (Prof Rawlins), copied to the MCA (Dr Jones). Plus: some good news for Mr Alder (MCA) and a reflection about the DISCUSSION sections on this site. See also The Lancet on "a disturbing story of reckless neglect" by the MCA (re: safety of human albumin). 19980825 New draft complaint re: lack of response to questions to Professor Rawlins. SSRI consumption figures updated. Reminders faxed to WHO and EU. 19980821 Still cocooned in Code exemptions: MCA reveals more about what it prefers to leave out and not to say. Social Audit replies: "... I have become intrigued by the idea of secrecy as an illness (Major Secretive Disorder) or an addiction ('exemption-seeking behaviour' etc) ..." 19980818 Final version of complaint to the Ombudsman referred by Richard Shepherd MP including tables showing extent of CSM members Declarations of Interests, 1992-1997. See also: 1997 and 1998 updates to Table of published reports of SSRI withdrawal reactions, and letter re: 'interested organisations' from MCA. 19980812 Fourth draft of complaint to Ombudsman, including analysis of CSM members' declared interests with SSRI manufacturers and other companies. 19980810 Third draft of complaint to Ombudsman. Peripheral stuff re: MCA/CSM relationship and the MCA's consultation process. Update of (1998) reports of SSRI withdrawal 19980806 Social Audit referred by EMEA to European Commission (DGIII). Second draft of complaint (superseded: see above). 19980804 More about 'important questions of operational practice': letter from MCA + reply from Social Audit, with first draft of complaint to Ombudsman. 19980731 "That hotch-potch of reasons you give for resisting on the grounds of 'Important Questions of Operational Practice' provides not so much as a fig leaf of justification for all this delay. You might just as well have been pointing out some tasteful arrangement of drapes around the cage, assuring me that the parrot was never dead - just deep in thought, and in need of an indefinite amount of time for quiet contemplation..." Social Audit to MCA 19980728 Re: the World Health Organisation. On possible conficts of interest, and recommended treatments for depression: correspondence with the Director of WHO's Division of Mental Health & Substance Abuse 19980724 Reply from EMEA about the quality of European warnings for SSRIs, and a repeat request from Social Audit. Reply from the MCA about "important questions of operational practice". Meanwhile, Patch Adams writes: "... Let's do it ..." (but it proved impossible) 19980721 Re Patch Adams (the man not the film). More on the need to investigate iatrogenic illness. And more about nothing from the MCA. Are they really considering "important questions of operational practice", or is this a constructive refusal to respond? Watch this space. 19980717 Letter to the Audit Commission re the need to investigate drug-induced iatrogenic illness, and their reply. 19980714 SSRIs, EMEA and the CPMP - "These words seem useless as a 'warning', if not negligent in their disregard for risk and of the opportunities for reducing it" ... Editorial Note plus covering letter to EMEA. 19980709 Bits and pieces from the MCA and DoH. Interesting Guardian report about low standard of 'scientific' drug studies: MCA/CSM take note. 19980706 Committee on Safety of Medicines (Prof Rawlins) seeks to bow out. Social Audit replies. 19980702 Important new report: Listening to Prozac but Hearing Placebo ... 19980701 Complaints upheld: MCA at last explains meaning of "consulting widely with relevant bodies". Also: preliminary response from Social Audit. 19980627 Preening letter from MCA, plus Social Audit reply, "acknowledging receipt of Polly's Certificate of Airworthiness and Full Pedigree..." 19980624 EMEA proposes a new 'warning' about withdrawal symptoms (not dependence) with SSRIs. To be discussed. 19980620 Letter from MCA (Mr Alder) re status of all outstanding Code requests, with brief response from Social Audit. 19980617 Letter to MCA (Mr Alder) re: procrastination & Polly's health. Follow-up letters to the EMEA (Prof Rolf Bass) and the DoH 19980615 Letter to The Committee on Standards in Public Life (Lord Neill); plus the Committee statement, The Seven Principles of Public Life 19980612 Re: confusion between the symptoms of withdrawal and relapse, and the implications of this for the assessment of the long-term effectiveness of antidepressants. Social Audit follow up letter to Professor Rawlins (CSM). 19980604 LIST OF MCA STANDARD OPERATING PROCEDURES (SOPs) with covering letter (15 May 1998) from MCA. 19980603 Response from Medicines Control Agency (Dr Jones) and reply from Social Audit: " ... It is as if I have been asking the Agency to produce the cat it claims to have in the bag, only to be repeatedly pointed to the label on the bag that says "CAT". So how come it keeps grunting?" 19980522 Prozac for physician stress? This is one of the themes in a keynote address, Medicine, Medicines and Health, given at an unusual conference: The Art and the Calling. 19980517 Social Audit response to Prof Rawlins. (See last entry). Request made for minute of CSM's decision to refuse disclosure. 19980515 Letter from Committee on Safety of Medicines. Prof Rawlins complains about innuendo and explains there is no basis for concern. CSM refuses request to disclose from its record of members' interests. 19980507 Letter from Medicines Control Agency (Dr Jones) and reply from Social Audit, including attachment: SLIDES re what 'dependence' really means. 19980505 Response from Medicines Control Agency (Mr Alder) and reply to it from Social Audit. If you want to read a version of this long, detailed MCA response which links each answer to the question asked, please click HERE 19980501 Two good new books from Dr David Healy now available. Also: you can now download The Antidepressant Web in Adobe Acrobat format. 19980430 Letter re: BMJ review of Adverse Drug Reactions (Pirmohamed et al, 25 April 1998, 1295-1298). This is the closest you'll come to an "official" estimate of the UK incidence of drug-induced disease. The small-print figures point to a colossal problem, apparently grossly under-researched. 19980421 How not to defeat depression? (Draft paper subsequently published in Open Mind, July/August 1998, 6-7). New data on venlafaxine (Effexor) withdrawal reactions (Fava et al, 1997) ... or lack of them? (Cunningham, 1997) 19980417 Letter to Secretary of State for Health, asking for Departmental estimates of the extent and cost to the NHS of drug-induced disease. Would the DoH broadly agree that, prescribed drugs cause a few tens of thousands of deaths, and a few hundred thousand hospital admissions, each year ...? Letter to EMEA to ask about the progress of its evaluation of SSRI dependence risk. 19980415 Letter to Medicines Control Agency (Dr Jones): "... the more harm you think would be done to the Company, the more I think that patients are at risk of being harmed - and the more I try to get to the bottom of this, the more I think in terms of 'regulatory capture'. Plus enclosure: resume of published reports of SSRI withdrawal and dependence problems - a 10-page A4 table. 19980412 Editorial Note: INDUSTRY SPONSORED CONSENSUS STATEMENTS? (Reflections on the editorial, Antidepressant discontinuation reactions Are preventable and simple to treat, in British Medical Journal, 11 April 1998.). 19980408 Letter from MCA (Dr Jones) refusing to retract its characterisation (Price et al., 1996) of SSRI withdrawal symptoms as rare and mild: "I have not found scientific grounds for taking this course of action". Also: more stalling from the MCA; new citation on paroxetine withdrawal (Arya, 1996) 19980402 Stalling letter from MCA, plus new citations on withdrawal problems with venlafaxine (Agelink et al, 1997, Giakas & Davis, 1997 and Rauch et al, 1996), and paroxetine (Bhuamik & Wildgust, 1996, and Pacheco et al., 1996). 19980327 None too exciting round of correspondence with the MCA (Mr Dunlevy) re definitions of commercial confidentiality. 19980326. Single case reports on SSRI antidepressant withdrawal (Amsden & Georgian, 1996; Landry & Roy, 1997; and Reeves & Pinkovsky, 1996). Also: paroxetine withdrawal symptoms seen in a study of panic disorder (Oehrberg et al., 1995). 19980320. Letter to Committee on Safety of Medicines, requesting copies of minutes of CSM meetings. Letter to Medicines Control Agency, to request list of all MCA Standard Operating Procedures, and to chase overdue responses. 19980317. Letter to Prof M D Rawlins, about arrangements made by the Committee on Safety of Medicines for declaration of members' interests. Brief response from Social Audit to Frank Dobson, Secretary of State for Health. 19980312. Reply from Frank Dobson, Secretary of State for Health. "With respect to your contention that SSRIs can cause physical dependence, I am advised that evidence to date does not appear to establish such an effect ..." 19980310. Further correspondence with the Medicines Control Agency, arising from its evidence to the Select Committee on Public Administration. 19980309. Letter to MCA, questioning its claims to openness made to the Parliamentary Select Committee on Public Administration 19980303. Background paper for debate at the Kings Fund Centre. Prof M D Rawlins, Chair of the Committee on Safety of Medicines proposes the motion: "The current system of drug licensing adequately represents the patients' interests". Motion opposed by CM. 19980225. New citations on SSRI withdrawal (Baer et al., 1994; Wolfe, 1997); on SSRI consumption and prescribing trends (Pincus et al, 1998); and one on direct-to-consumer advertising and promotion of SSRIs (Freudenheim, 1998) 19980220 New round of correspondence with the European Medicines Evaluation Agency - "Your enclosed paper, The Antidepressant Web, has been distributed to all relevant experts. Evaluation of the risk of dependence on SSRI antidepressants has been initiated." See also: review of new book by Thomas J Moore; editorial note: Hook+Tangle Dependence. 19980218 New round of correspondence with the MCA and a short, further submission re the White Paper on FOI; and some general tidying up 19980216 ADWEB LAUNCHED ON PILOT BASIS, 16 February 1998.