Botox approved for the prevention of chronic migraine

This'll make you laugh. It did me, anyway:

Botox approved for the prevention of chronic migraine

I was listening to BBC Radio 4, and an item came on the news. I checked the date several times, and having satisfied myself that it wasn't 1 April, I thought I'd poke some fun!

Regrettably, it's not mentioned in the piece cited, above, but in the radio "news" piece, it was said that a trial was carried out based upon "anecdotal" reports by those using Botox for the purpose of losing all expression in their facial muscles also experiencing a reduction in migraines. Now, it was my understanding that the MHRA didn't give a shit about anecdotal evidence, but apparently on the back of these reports, a trial was arranged. And the drug was approved for this secondary purpose.

I look forward to the MHRA deciding that anecdotal evidence of withdrawal problems, suicidality, akathasia, etc, etc, is worth a trial. But, then, it's not the MHRA that carries out the trials, is it? It's (mostly), the companies. The distinction between this case and SSRI adverse events is that there is no money to be made from proving that SSRI are placebos with lots of side effects. Is there?

Addendum:
Is there a direct correlation between the desire to have an expressionless face, and suffering from migraines? Put another way, do people who wish to look like Commander Data suffer migraines at a greater rate of incidence than the wider population?

Recording: British Paxil Users Meet With Brit FDA

Furious Seasons has posted the audio recording of the recent meeting between representatives of the Nine Elms Massive and patient advocates. I've made a couple of comments on there, if you're interested (and even if you're not interested, I've still made a couple of comments), but the upshot is that the Establishment has decided to defend its position - there is no attempt being made to address the issues with the industry that several commentators and patient advocates have raised. It seems to be about justifying the status quo, when the status quo is shit.

I listened to the recording for 36 minutes, and I was so disgusted with the whole fucking thing that I refused to expose myself to it, any further. It sounded very much like a PR exercize, nothing more. If the MHRA was really listening, it would be including its biggest (or at least most vocal), critics in the discussion and it would be addressing the issues that they raise, instead of justifying the machinations of the system, which, in their totality, I argue achieve precisely the opposite of what it is argued is being achieved.

What is being done to address the way in which companies have complete control over the trial of drugs, statistical analysis and writing of papers? What is being done to establish regulatory rules and guidelines, which fill the gaps left by legislation? Will the UK regulator address the question of its apparently flimsy assessment process - for example, why does it accept those dodgy academic papers as valid evidence of safety and efficacy, when there is evidence that this business of "information laundering" renders academia unreliable, to say the least?

Oh, it's all bollox - the halfwits don't want to change a damn thing, because it's not in their interests to change anything, and because they don't know how.

Matt

More opaque than an opaque thing... Part IV

I thought I might as well go through all the hoops and mail the Head of the absurdly-named Intelligence and Enforcement Unit, at the MHRA. This to Michael Deats, copied to Woods, Breckenridge, Vara, Johnson and the CPS:


Dear Mr Deats,

I am currently engaged in a discussion with Professors Woods and Breckenridge and the CPS (please see below) on a question over the application of Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).

Would it be your position, as Head of the Intelligence and Enforcement Unit at the MHRA, that where trials have been carried out on a drug, and those trials have produced negative results, and that there are also trials of that same drug that have yielded results that are interpreted as positive, and it is subsequently only the positive results that are submitted in support of a marketing authorization application, that the presentation of only the positive data (owing to the suppression of the negative data) amounts to the provision of "false or misleading" information, under Regulation 50?

Best regards

Matthew Holford

The MHRA - taking patient reporting seriously - Part IV

Well, I feel properly satisfied with the outcome of this. Thank goodness my experience isn't a trivial matter for those who have an interest in the drugs I take:


Dear (redacted),

Many thanks for this. I believe it answers my questions satisfactorily, and I consider the complaint dealt with.

The issue, then, lies elsewhere: the manufacturers are not responsible, because the risk of suicidal ideation was noted on the PIL; my GP was not responsible, even though he was responsible for my care, because he brought the side effect to my attention, when he prescribed the drug (and then, when I experienced the side effect, told me that it wasn't the drug); the MHRA is not responsible, because it is not required to be responsible.

May I ask who is responsible - and this is not a rhetorical question, I would like an answer? Could you seek guidance from the Secretary of State on this one, please, because I am keen to understand whether it is believed that I should be responsible for my reaction to chemicals that, with the greatest of respect to the MHRA, are not controlled particularly effectively, judging by the less than scientific approach that is taken to licensing (both by manufacturers and regulators)?

I have to be honest, rarely have I experienced such a sorry catalogue of failure and incompetence as this. There are so many gaps in this system that it is a wonder to me that anybody survives it. More to the point, when a flaw is identified, the MHRA (and others) appear determined to argue that everything is just hunky dory, and that a complainant is somehow deranged to even suggest that anything is wrong. In short, full defensive mode is initiated. And yet, the MHRA is characterized as a world leader?

Best regards

(redacted)




********************************
From: "Pharmacovigilance,"
To: (redacted)
Subject: Yellow Card Complaint
Date: Mon, 10 Sep 2007 10:36:39 +0100


Dear (redacted)

You raised a formal complaint that your Yellow Card report was not subject to follow-up. This complaint has been investigated by the Signal Management Group and I will address your concerns below.

Further to your Freedom of Information (FOI) request FOI 07-246 on the 15th August 2007 concerning the Yellow Card Scheme, a response was sent to you on 30 August 2007 explaining what a ‘follow-up’ is and detailing the process by which it is determined whether it is necessary for a Yellow Card report to be followed-up. Please refer to this communication for further explanations of the process of ‘follow-up’. In summary I will reiterate that the term follow-up refers to the communication with the reporter to request further information regarding their Yellow Card report.

The following up of a report is at the discretion of our pharmacovigilance scientists and assessors at the MHRA and is in no way a compulsory part of the Yellow Card Scheme. As stated in the FOI 07-246 response the request for further information or ‘following up’ of a report does not necessarily signify these reports are of greater importance or interest.

With regards to your Yellow Card report, I can confirm it was determined a request for further information from yourself was not necessary at that time for two main reasons:

Firstly the report you completed was adequately filled in to provide enough information to be entered onto our database for rapid analysis and assessment by our physicians, pharmacists and scientists.

Secondly the suspected adverse reaction reported by yourself was suicidal ideation. As you are well aware, Suicidal ideation is listed as a potential side effect in the Patient Information Leaflet (PIL) for fluoxetine. Whilst we are not in any way dismissing the seriousness of this reaction, this in itself does not necessarily warrant a Yellow Card report being followed up.

The risk of suicidal ideation and suicide with SSRIs are continually monitored by the MHRA. In May 2003, in response to continuing public concerns about the safety of SSRIs, an Expert Working Group of the Committee on Safety of Medicines (CSM) was convened to investigate ongoing safety concerns with these medicines, in particular around suicidal behaviour and withdrawal reactions/dependence. I believe you are already aware of this ‘Report of the CSM Expert Working Group on the Safety of SSRI’s’ and your questions regarding its contents and conclusions have already been satisfactorily addressed.

With regards to provision of the manufacturer’s details of the generic fluoxetine you were prescribed, I am unable to provide you with this information. Currently there are approximately 32 marketing authorisation holders for generic brands of fluoxetine in the UK and therefore I am not able to inform you which of these MAHs provided the fluoxetine you were prescribed by your practitioner. However the MAHs name would clearly have been stated on the packaging and also on the Patient Information Leaflet provided with the pack as a legal requirement.

I hope you feel this letter addresses your complaint in all respects. If you remain dissatisfied, you can make representations to the Central Complaints Officer:

(redacted)
MHRA
16-107 Market Towers
1 Nine Elms Lane
Vauxhall
SW8 5NQ

More opaque than an opaque thing... Part III

I'm a bit disappointed with the feedback I'm getting from the MHRA, just now, so I thought I'd try a different angle. This was sent to Breckenridge and Woods, copied to Johnson, Vara and the CPS:


Dear Professors Breckenridge and Woods,

My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.

Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?

Best regards

Matthew Holford

*************************



Dear Sir or Madam,

I am currently engaged in a discussion with the MHRA, concerning the application of the Medicines for Human Use (Clinical Trials) Regulations 2004 (please see below). It appears that the MHRA is unable to provide an opinion, for whatever reason that it might have.

Is the CPS positioned such that it may provide definitive guidance as to the nature of conduct that would constitute a contravention of Regulation 50?

Best regards

Matthew Holford

********************************

I see a sign... it is a good omen!

The MHRA was kind enough to follow up on a matter that I raised with it a little while back. I'm not sure that it says anything new, particularly, but it's always good to hear from somebody different. The MHRA's correspondence is emboldened, as usual:


Dear (redacted),

I have had an opportunity to read through your letter, for which, again, many thanks. I have the following comments/questions:

I believe the hypothetical scenario relates to a question that I put regarding the investigation into the GSK vaccine business, in Russia. As far as I know, there have been no decisions made as to GSK's culpability, as yet, and as such I understand that you would not wish to speculate on such a matter. In the event, one of the GSK shareholders in the House was kind enough to refer the matter to the then Secretary of State for Health, Patricia Hewitt. The DoH advised me, via the shareholder, that the MHRA does not concern itself with matters that relate to events in other jurisdictions. As such, I feel that I am as well informed on this matter as I care to be.

As to risk/benefit assessments, I believe that that very precise figure of 83 trials relates to a paper that I had read. If I remember aright, it was a piece by Peter Breggin. I regret that I do not have specific details of the trials to which (I presume) Dr Breggin was referring.

However, while I understand from your comments that the MHRA's risk/benefit analysis is perhaps more subjective than objective, I was rather more interested in the procedure involved? I see that 50 trials were held to demonstrate the efficacy of the drug - did any of these involve a review of the raw data, or were statistical summaries only provided?

Either way, I would be interested to understand how "efficacy" was demonstrated, given that Mr Goldfinch has advised me to the effect that it was not necessary for an applicant to demonstrate the level of efficacy, merely that there was efficacy. I must confess that I am struggling with this one, because if one doesn't have a frame of reference, then it will not be possible to judge whether a drug is efficacious, or not, I should have thought. Indeed, unless placebo and drug's performance are measured against the same scale, then any amount of numbers will be meaningless, irrespective of what the applicant says that the summary demonstrates. Furthermore, one may not say with confidence (nor with the conviction of truth) that a drug is better than placebo, if one does not know what the drug scored, relative to the placebo. Nor will it help if one is unaware as to what the placebo scored.

In summation, then, I am keen to understand the procedure followed in the assessment process, including the risk:benefit analysis, however mercurial the latter element may be?

Best regards

(redacted)

--------------------------------------------------------------------------------
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: FOI 07/088 Seroxat
Date: Wed, 5 Sep 2007 15:56:57 +0100


Dear (redacted),

Please see attached response to your previous query, and please accept my apologies for the considerable delay in responding.

Kind regards

(redacted)
Licensing Division
MHRA
Tel 0207 084 2391
Fax 0207 084 2323

Attachment:
FOI 07/088

Dear (redacted),

Regarding you enquiry back in 9 March 2007, I regret that this was not addressed at the time, however I am able to address your queries which was as follows:

“I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?”
The MHRA is unable to comment on a hypothetical scenario.

“I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.”

Without a list of the 83 trials to which you refer it is not possible to say which of those trials the MHRA has viewed the results of. However, I have been able to ascertain the following information from the original assessment report:

Human Pharmacology: 59 studies were analysed and presented Pharmacokinetic data was obtained from over 60 studies; Drug interaction data was obtained from 30 studies; Efficacy data was supported by over 50 studies (11 Placebo controlled studies; 16 comparator studies; 4 double blind comparator studies, 5 long term efficacy studies; 19 open studies). Safety data will have been obtained from the above mentioned trials.

Regarding the technicalities of the MHRA’s risk analysis. There is no magic formula that can be used to weight the risk/benefit analysis, it is purely a case of considering the benefit(s) that the patients in the trials have experienced against the potential and demonstrated adverse reactions reported in the trials. Obviously the severity and the reversibility of reported adverse reactions need to be carefully balanced against the benefit to the patient of taking the product. The quality of life of the patient if untreated is also a factor that has to be taken into consideration. For some products it may be very easy to establish risk/benefit, however, there are those where the risk/benefit is less clear cut. This is one of the reasons why all new chemical entities (medicinal product) are considered by the Commission on Human Medicines (previously the Committee on the Safety of Medicine) and it subcommittees before a marketing authorisation is granted. It is also the reason why all new drugs have a black triangle for at least 3 years following the initial granting of a licence, to warn prescribers to be vigilant as this is a new product for which there is only limited experience.

If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.

Yours sincerely



(redacted)
Licensing Division
MHRA

--------------------------------------------------------------------------------

From: (redacted)
Sent: 09 March 2007 17:21
To: MHRA Information Centre
Cc: The Four
Subject: RE:


Dear Sir or Madam,

Thank you for your kind reply.

I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?

I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.

Best regards

(redacted)

The letter of the Law (but what of the spirit?)

In the light of the previous post, I thought it might be worth reminding everybody just how excoriating (if one was paying attention) some of the commentary of the Health Select Committee's report into the influence of the pharmaceutical industry was. It's a riveting read, if you're into that sort of thing...

The Report is available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf, if any readers feel inclined to trawl through the 100+ pages for themselves. Pertinent extracts, in support of my last post, follow:


282. The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry, the main exception being Prof Woods, who became chief executive of the MHRA in 2004. Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it. Dr Herxheimer stated:

…when the agency was hived off from the Department of Health…the culture became confirmed that the industry is the client and the client must be looked after: quick service, good service, easy contact, etcetera - so it is a closed community in a sense.

283. Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process. The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate [my emphasis]. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

284. Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; it should be earned rather than presupposed. The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable, as Sir Iain Chalmers [co-conveners of the James Lind Alliance] commented:

Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

285. Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem: the December 2004 report of the CSM’s Expert Working Group (EWG) into the safety of SSRI antidepressants. The Group’s main findings pointed to lack of evidence of risk (rather than risk itself) not least because a number of essential studies had never been performed...

That MHRA Complaints Procedure in full

Please note that this procedure is followed in the event that the MHRA receives a complaint about its administrative activities. There is a separate review procedure, with respect to FOIA requests (which I don't have copy of).

Matt

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
AGENCY PROCEDURES Ref : GEN020/04
Title : Handling Complaints
Effective date
29/03/07
Review date
28/03/09

1. SCOPE

1.1. To define the MHRA procedures for the handling of complaints about administration or levels of service. It does not cover formal appeals against licensing, regulatory decisions on devices or enforcement decisions. It includes details of the "Independent Complaints Adviser" system, and referral to the Ombudsman.

2. INTRODUCTION

2.1. All organisations receive complaints from time to time and the MHRA is no exception. Information from complainants can be used positively, as a way of improving our services. The following procedure is intended to ensure that all complaints are handled consistently and effectively throughout the Agency, with the aim of treating all complainants fairly and, as far as possible, to their satisfaction.

2.2. The procedures described in this SOP apply to all MHRA staff.

3. GENERAL

3.1 What is a complaint?

3.1.1 There can be no hard and fast rules about what constitutes a complaint, and this part of the SOP is intended as guidance only. Broadly speaking, a complaint is an expression of dissatisfaction about the MHRA's service provision. These can be made both orally and in writing. If an oral complaint is made the complainant should be asked to submit the complaint in writing.

3.1.2 In short, for the purposes of these procedures, a complaint is a representation from someone who is:

- disagreeing with an administrative decision, concerning them, taken by the MHRA; or

- unhappy with the way an administrative matter has been handled by the MHRA.

3.1.3 In addition, the MHRA may receive complaints concerning Parliamentary Questions (PQs), Private Office cases (POs), Ministerial statements or articles published by MHRA staff. These should be dealt with in the following ways:

- Parliamentary Questions or Private Office cases or other Ministerial statements.

Complaints regarding Parliamentary Questions or Private Office cases or other Ministerial statements should not be addressed by MHRA staff and should be referred to Private Office. If the complaint covers PQs etc., together with other issues concerning the Agency, staff will be advised by the Agency’s Central Complaints Officer (CCO) as to which areas of the complaint they should address.

- Published Articles.
If the complaint relates to published articles where MHRA staff are authors or part authors the complaint should be referred to the CCO for advice.

4. SPECIFIC

4.1 What to do if you receive a complaint

4.1.1 When a complaint is received it should be acknowledged within 5 working days. The complaint should be logged, investigated and a response sent directly to the complainant from the relevant unit/division. For the majority of complaints, they will be resolved at a local level with the initial response, without the need for further action.

A full record of all correspondence in relation to the complaint should be kept.

If a complaint is received, in the first instance, by the Central Complaints Officer (CCO), the CCO will forward it to the relevant unit/division for resolution at a local level. A copy of the complaint should be held on file by the CCO. Again, the unit/division should acknowledge receipt of the complaint within 5 working days and proceed with its investigation and response.

4.1.2 The guiding principles at all stages of dealing with a complaint should be:

- speedy handling;

- answering all points of concern;

- being factually correct;

- fair investigation;

- effective response;

- confidentiality.

4.1.3 Replies should also:

- provide an apology (if appropriate);

- correct any misunderstandings;

- be signed by the officer dealing with the complaint;

- provide contact details (including fax and e-mail).

4.2 Specific action to be followed

Resolve the complaint locally

4.2.1 Attempts should be made to resolve the complaint as quickly as possible at a local level i.e. group/unit/divisional head level whichever is the most appropriate. The response should advise the complainant that “if they remain dissatisfied, they may make representations to the Central Complaints Officer”.

Complaint to the Central Complaints Officer (CCO)

4.2.2 As soon as a complaint to the CCO is received in writing, it should be sent to Central Complaints Co-ordinator (CCC) (see details below). Written complaints sent directly to the Chief Executive or Board Member should also be referred to the CCC immediately.

4.2.3 The CCC will send an acknowledgement letter to the complainant within 5 working days, register the complaint, inform the CCO and raise a file with an identifying number. The file will contain the letter of complaint and all subsequent correspondence.

4.2.4 The registered file will then be sent, by the CCC, to the relevant part of the Agency for a report. Relevant staff should maintain a simple record on the file of the action taken (by whom and when) as it may be necessary to refer to this later if the complaint cannot be resolved quickly or becomes more involved.

4.2.5 The report should be sent (by email) to the CCO within 6 working days of the date of receipt. The report should be placed on file. If this is not possible to provide a report within the stipulated time-frame, the CCO should be notified and given an indication of when the report will be provided.

4.2.6 All complaints will be considered thoroughly by the CCO. The circumstances leading up to the complaint should be fully and objectively reviewed before a reply is drafted. If it is necessary to consult with others for information or opinions, a record should be made and copies of any exchange of correspondence should be kept on the file.

4.2.7 The CCO will communicate the outcome of the review to both the
complainant and the relevant unit/division.

If the outcome of the review is in the complainant's favour, remedial action/an apology (or both) may be necessary.

- If the outcome is not in the complainant's favour, a full explanation must be included in the reply, even if one has been given previously.

- If the outcome raises questions of policy or is likely to have an impact elsewhere in the Agency, the necessary information should be passed by the CCO to the relevant person(s).

4.3 Referral to the Chief Executive

4.3.1 If, following an investigation and reply by the CCO, the complainant writes to say he/she is still dissatisfied with the outcome or the way the complaint has been handled, the CCO may decide, if appropriate (e.g. if referring the matter to the Chief Executive will add value to the complaints process), to refer the matter to the Chief Executive's Office.

4.3.2 Further action, including a further substantive reply, will be directed by the Chief Executive in discussion with the relevant part of the Agency. The Chief Executive’s office will respond within 20 working days. At this stage, the Chief Executive will advise the complainant of his/her right to contact the Independent Complaints Adviser, who has the power to investigate complaints fully and make representations to us on behalf of the complainant.

4.4 The Independent Complaints Adviser (ICA)

4.4.1 A matter may be referred to the ICA either after the CCO has unsuccessfully tried to resolve it, or one stage later after the Chief Executive has also unsuccessfully tried to resolve it.

4.4.2 The role of the Independent Complaints Adviser is: "To investigate complaints against the Medicines and Healthcare products Regulatory Agency leading to a dispute between it and the complainant, on matters relating to administrative actions. To make recommendations concerning resolution of the specific complaint, and, where appropriate, advise on a suitable form of redress. Also, where MHRA operating procedures appear at fault, to make recommendations for improvement."

4.4.3 The ICA will acknowledge the complaint within 5 working days.

4.4.4 Initially, the ICA may try to resolve the matter informally by discussion with the Board Member or line manager concerned. If a more formal course of action proves necessary, the ICA will investigate the circumstances fully and provide a report of any findings and any recommendations simultaneously to the complainant, the MHRA's Chief Executive and the relevant Board Member.

4.4.5 If the report cannot be sent within 20 working days, the ICA will write to the complainant explaining that the matter is being dealt with and giving reasons for any delay.

4.4.6 Following the submission of the ICA's report to the complainant, the Chief Executive and Board member, the report will be submitted to the next MHRA Board meeting for discussion and agreement on any policy or procedural changes recommended by the ICA.

4.5 The Ombudsman

4.5.1 If, following the ICA's report and the MHRA Board's consideration of any policy or procedure changes recommended by him, the complainant is still dissatisfied, he/she may refer the complaint to the Ombudsman through an MP. The letter from the ICA accompanying his report to the complainant should include a statement to this effect.

4.6 Monitoring

4.6.1 The Central Complaints Officer will be responsible for ensuring a record is maintained of complaints received and dealt with by him/her, of subsequent action and for supplying statistics to the MHRA Board.

A summary of the full process is at Appendix A.

For further information and advice on Risk Management contact the Central Complaints Officer, Deputy Central Complaints Officer or Central Complaints Co-ordinator whose details can be obtained on Policy’s site on Insite.

5. APPENDICES

Appendix A – Summary of the complaints process

6. CROSS-REFERENCES
GEN 037: Corrective Action
GEN 038: Preventive Action

7. REVISION HISTORY

Issue Effective Date Reason for revision Prepared by

01 01/01/2000 M Gosling
02 01/03/2005 Updating L O’Brien
03 19/06/2006 Reformatting and S Jones/

Updating S Fletcher
04 29/03/2007 Updating S Jones/S Fletcher

8. KEY WORDS
Complaint; parliamentary question; private office case; central complaints officer;
central complaints co-ordinator; independent complaints adviser; ombudsman

APPENDIX A


SUMMARY OF COMPLAINTS PROCEDURE


C O M P L A I N T
MHRA UNIT / DIVISION LOG AND ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS
INVESTIGATE COMPLAINT AT GROUP / UNIT / DIVISIONAL
HEAD LEVEL
RESPONSE TO COMPLAINT
IF COMPLAINANT REMAINS DISSATISFIED WITH THE AGENCY’S REPLY, THEY MAY MAKE REPRESENTATIONS TO THE C.C.O.
CENTRAL COMPLAINTS OFFICER (C.C.O.) LOG AND ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS
REPORT FROM RELEVANT DIVISION TO C.C.O. WITHIN 6 WORKING DAYS OF RECEIPT OF FILE
OUTCOME IN COMPLAINANT’S FAVOUR
REMEDIAL ACTION / APOLOGY
ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS REPORT / UPDATE MATTER AND REASON FOR DELAY
WITHIN 20 WORKING DAYS
INDEPENDENT COMPLAINTS ADVISER
CHIEF EXECUTIVE: RESPONSE SENT WITHIN 20 WORKING DAYS
OUTCOME NOT IN COMPLAINANT’S FAVOUR
COMPLAINANT NOTIFIED OF OUTCOME.
IF COMPLAINANT REMAINS DISSATISFIED:

Abuse of Trust IV - Russia charges 3 doctors over Glaxo vaccine tests

""Many of the children sent for trials had been diagnosed with diseases. They (GSK) had no right to put children with health problems through these clinical tests. It can lead to a deterioration in the child's condition, which has happened in the case of some of these children.”

...A company spokeswoman said its own internal audit showed informed consent had been given by all parents and doctors involved in the trial."

Read on: http://glaxosmithklinenews.blogspot.com/2007/03/uninformed-consent.html

This is a relatively old story (5 or 6 months, or so, and there doesn't appear to be anything new on it, judging by my Google search). This was the case that I contacted the DoH (and the MHRA) about, and it is the case that the One of the Four contacted me about ("Delighted to engage GSK shareholders" (below)). I was told that the MHRA knew no more about it than what was avaialable in the press.

What a bunch of jobsworths!

Matt

Re: FOI 07/118

I had an afterthought, this morning, which I've just communicated to the Clinical Trials Unit:

Dear [redacted],

As an afterthought: if it is not a criminal offence to withhold trials data, nor, as I understand it from your letter, is it a criminal offence to fail to provide a summary of results/statistical analysis, may I ask how it is possible for the MHRA to investigate GSK for withholding trials data (an investigation that has gone on for over three years, now, I understand)?

Put another way, is there an offence on the statute book that amounts to "Withholding clinical trials data/statistical analysis/summary of results"?

Best regards

Matthew Holford

Re: FOI 07/118

I received a response from the MHRA to a query I put to it back in April, but which it overlooked, at the time. Much as it galls me, I've had to type it up, because I can't work out how to drop in the original Acrobat document, which was attached! My original 'mail is immediately below and my reply is beneath the MHRA's missive, which I've emboldened, for convenience. Make of it what you will, although I would like to draw your attention to the MHRA's "catchphrase," which is "Safeguarding Public Health."

Matt

From: Matthew Holford
Sent: 12 April 2007 15:51
To: MHRA Information Centre
Cc: [redacted]@gsk.com; [one of the Four]@parliament.uk; [one of the Four]@parliament.uk; [one of the Four]@cix.co.uk; [one of the Four]@parliament.uk; [my MP]@parliament.uk
Subject: FOI 07/118 - Medicines regulation and the pharmaceutical industry


Dear Sir or Madam,

I was interested to read the article, by your esteemed Chairman and CEO, respectively, Prof Breckenridge and Kent Woods:

http://www.bmj.com/cgi/content/full/331/7520/834

I must confess myself surprised and delighted to discover that the MHRA charges companies, for the purpose of licensing trials. As such, it is presumably aware of any trial, for which it has granted a licence, and for which it does not receive trials results, including details of elements of that trial conducted in other countries? Does the MHRA keep records of any such failure to notifiy, or is its interest limited to collection of the trial fee? If it does, may I ask from what date it began keeping this information? Also, may I ask what percentage of authorized trials do not have the results notified to the MHRA? May I ask what action it takes, in the event that a failure to notify has taken place? Indeed, may I ask what period of grace, after the end of the trial, does the MHRA permit companies, before commencing legal action, under the relevant legislation (The Medicines for Human Use (Clincial Trials) Regulations 2004 (http://www.opsi.gov.uk/si/si2004/20041031.htm#28))?

Finally, I note that the offences, identified under ss49-50, shall be subject to a fine or a maximum period of imprisonment not exceeding two years (ie, they are considered not to be a serious arrestable offences), upon conviction on indictment. The maximum fine, which is defined by statute, is currently £5,000, I believe. To what extent does the MHRA understand these penalties to be an adequate deterrant to non-compliance with the Law?

Best regards


Matthew Holford

***********************

22 August, 2007

Dear Mr Holford

It has been brought to my attention that you have not been provided with a response to your request for information under the Freedom of Information Act (FOIA) made on 12 April 2007. I apologise for this oversight and I provide a response below:

The Clinical Trials Directive 2001/20/EC and the UK implementing legislation (SI 2004/1031) refer to the sponsors' liability to notify the competent authorities of concerned Member States of the end of a trial within 90 days of its completion. There is no reference however to notification of trial results.

The implementing European Commission guidance ENTR/F2/BL/D 2003 Revision 2:

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. [MHRA's emphasis]

refers in section 4.3.2.4: Clinical Trial Report: "The sponsor should provide a summary of the clinical trial report within one year of the end of the trial to the competent authorities of the concerned member states..."

The above legislation and guidance came into effect on 01 May, 2004. In the UK prior to that date the clinical trial legislation placed no obligation on trial sponsors to notify the competent authority of the results from clinical trials, at the end of the trial.

The MHRA has therefore to date, not kept records of where trials results have not been notified to it, following completion of clinical trials in the UK.

I hope this is helpful and once again I apologise for the delay in replying.

Yours sincerely

[redacted]
Clinical Trials Unit

*************************

Dear [redacted]

As you may appreciate, I'm not fully conversant with the way in which the various pieces of legislation "mesh". If I understand correctly, then, a clinical trial must be licensed in order to proceed. Upon completion (or presumably early termination) this must be communicated to the MHRA (in the UK), within a certain specified period of time, with failure to do so being a criminal offence. It is also my understanding that the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) provide that information must not be provided that is false or misleading. Regulation 50 provides, if I remember aright.

From your comments, it is apparent that a sponsor may, if it so wishes, not provide the results of trials that have been completed and such completion presumably properly reported. If received wisdom is to be believed, this will be because a trial has "failed". In any event, results data is regarded as proprietary within the industry, and a company may not be compelled to give it up. Indeed, if I understand correctly, trials data is not generally given up, even where a trial is deemed "successful" and used in the marketing authorization application portfolio to demonstrate the "efficacy" of a drug, even where, as is apparently the case with Seroxat, the level of efficacy has not been demonstrated. Instead, a statistical analysis is usually provided. None of this sounds terribly scientific to me, but then I'm a compliance professional, not a drugs regulator.

I would be interested to understand how the MHRA views this withholding of data? We know that certain Seroxat trials "failed", and the results were not made public. Others were held to demonstrate efficacy, and a statistical report based on the successful trials was presumably made available to the MCA/MHRA with the licensing portfolio. This presumably purported to demonstrate efficacy (although not very precisely, as I understand it), safety and quality, or else the product would not have been licensed.

If something similar were to happen today, would this withholding of data be deemed to amount to an offence under Regulation 50 by the MHRA? That is, if a company provides less than all the information about a drug, and the information withheld is negative, then the information that is provided is presumably false, or misleading. Also, does the MHRA endeavour to ensure that it has, at least, a statistical report from all trials conducted on a particular drug, in the event that a marketing authorization is sought for that drug?

I would be interested to read of your views.

Best regards

Matthew Holford

The MHRA: taking patient reporting seriously

Dear All,

I've just spent a short break down in the West Country. And very nice it was, too. Now, fully rejuvenated, I felt inclined to escalate my complaints up the MHRA foodchain. To which end, I've just had this little exchange with our esteemed drugs regulator. I've emboldened the MHRA's reply, for convenience:

Dear Sean,

It's remarkable how one's memory can play tricks on one, is it not? Perhaps it was the DoH that I had that conversation with. Or the ABPI. Or my doctor. Or the NHS. Or the Samaritans. Or my colleagues. Or my blog. In any event, my primary concern is not that the MHRA overlooked an issue that I believe I raised with it, but rather that it appears to have failed to do what it purports to do; that which it appears to exist to perform; and, moroever, that which it asserted to be valuable. Perhaps we should focus on that?

In any case, thank you for your kind attention. Given the background to this particular request, perhaps I can rely on the MHRA not to brand it vexatious, on this occasion?

Best regards

Matthew Holford

From: [redacted]
To: Matthew Holford, "MHRA Information Centre" info@mhra.gsi.gov.uk
CC: [Alan Johnson], [Shailesh Vara], [Alasdair Breckenridge], [Kent Woods]
Subject: RE: Yellow Card scheme
Date: Wed, 15 Aug 2007 10:38:31 +0100

Dear Mr Holford,

I refer to your email below.

Having read through your earlier FOI requests which form the subject of my review, I have not encountered any questions which relate to the Yellow Card Scheme. You are, therefore, correct in stating that this is not under consideration in my review.

As there does not appear to be a record of you having asked a question on the Yellow Card Scheme before, I have requested the Information Centre to treat this as a new FOI request. They will acknowledge your request and refer your questions to the appropriate unit who will respond to you directly.

Kind regards,

[redacted]

From: Matthew Holford [mailto:m.holford@hotmail.co.uk]
Sent: 15 August 2007 02:46
To: MHRA Information Centre
Cc: Alan Johnson; [Shailesh Vara]; [redacted]; [Alasdair Breckenridge]; [Kent Woods]
Subject: Yellow Card scheme

Dear Sean,

It occurred to me recently that I have asked about the Yellow Card scheme, during the course of my enquiries. However, this does not appear to be under consideration, in your review.

I was keen to understand how the scheme operated, or didn't operate, as the case may be. At the time of its roll-out, back in October, 2005, Dr Patricia Wilkie, Chairman of the CSM’s Working Group on Patient Reporting, declared that direct patient reporting was essential for medicines safety monitoring. Moreover, it would be an important source of information for patients about their medicines. Meanwhile, the MHRA's CEO, Kent Woods, declared that it would provide new insight - he was right about that, at least - and that it would permit patient involvement in regulation. I would be interested to understand how those objectives are achieved? In detail, please.

Also, you may be aware that just less than half of Yellow Card reports are followed up (according to your esteemed Chairman, Professor Sir Alasdair (that's D-A-I-R) Breckenrdige). Perhaps the MHRA could explain to me how it is that this fact contributes to either Dr Wilkie's or Mr Wood's objectives?

Finally, having submitted a Yellow Card myself, following suicidal ideations experienced whilst taking fluoxetine, I regret to report that I have been one of the unlucky 51% who has received a perfunctory hard copy, but no follow up. Having no experience of the process, I would be grateful if the MHRA could explain what "follow up" means? Does it have any familial relationship with NICE's "careful and frequent monitoring," by any chance?

I find it difficult to believe that my experience is untypical. However, I don't imagine that I'm your typical dissatisfied customer, either. The MHRA's response has been slipshod at best. At worst I daren't think what it is. Either way, I'm going to find out.

Best regards


Matthew Holford

PS to Mr Johnson: is it true that the Police and Criminal Justice Act 2001 had several key provisions introduced at the behest of the Worshipful Company of Apothecaries (ie, Big Pharma)? If so, could I request just one inclusion, the next time an amendment is made to the CJA - not to be treated like a twat by government bodies? I know that this is a personal request, but I'm sure others could benefit. Thanks everso.

Forty-three Years of Yellow Cards, or Ethon's Retribution

The Yellow Card Scheme is a British initiative run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) to gather information on Adverse Drug Reactions (ADRs) to medicines. This includes all licensed medicines from medicines and vaccines issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines found in cosmetic treatments. ADRs can be reported by anyone; generally healthcare professionals including doctors, pharmacists and nurses, as well as patients and carers.

The sort of ADRs that should be reported are:

• ADR's that have caused death or a serious illness
• Any ADR, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary (BNF) with a ▼ black triangle)
• Any ADR, however minor, if associated with a child (under 18 years of age)

Yellow Cards are available from pharmacies and a few are presented near the back of the BNF as tear-off pages.

Reports from the Yellow Card scheme are available from the MHRA website.

Source: Wikipedia

Well, that's clear enough, isn't it? Incidentally, to all intents and purposes, the above is the information provided on the MHRA website, where it accompanies links to online Yellow Card forms. So, if our doctor doesn't complete a Yellow Card on our behalf, when we complain to him/her of something subsequent to taking a drug, we can always go online and complete a form, which the MHRA will address. Incidentally, I should mention that the Yellow Card scheme was set up in 1964, following the Thalidomide tragedy (this is the language used by the NHS Wales website, by the way).

Mind you, this business of patients reporting their own experiences is a relatively new thing, seemingly prompted by a recommendation made by the Health Select Committee, following its report into the influence of the pharmaceutical industry, in 2005 - the only recommendation it made that was taken up, to my knowledge - which suggested that a country-wide system of patient reporting be put in place "as soon as possible". The NHS Wales website carries a nice little piece, complete with jolly quotes-you-like from your favourite healthcare bureaucrats, which is dated October, 2005, at the time of the UK pilot roll-out. I didn't realize it was as recent as that. Importantly, for Kent Woods, CEO of the MHRA, patient reporting would provide new insight and permit the public to become involved in medicines regulation. My own experience with the MHRA suggests that public involvement goes no further than filling out Yellow Cards.

Meanwhile, Dr Patricia Wilkie, Chairman of the CSM’s Working Group on Patient Reporting, was even more effusive about the role of direct patient reporting, declaring that it was essential for medicines safety monitoring. Moreover, it would be an important source of information for patients about their medicines. However, as ever, there is a counterproposition to this optimistic propoganda.

Back in August, 2003, Charles Medawar reported that he had conducted an analysis of anonymized Yellow Cards pursuant to a series of investigations undertaken by the BBC's Panorama, concerning the risks associated with Seroxat. He and his co-authors discovered significant failings in the way the system was being operated. "Chaotic and misconceived" was the upshot, if I remember correctly. The MHRA had seemingly systematically failed to follow up on reports of patient suicidality. Yellow cards submitted by drug companies used euphemistic language to conceal the true nature of the side effect experienced. Similarly, several different terminologies would be used to describe essentially the same complaint, thus making a side effect look less significant in terms of its occurrence than was the true case. And so on.

However, you will be pleased to know that the MHRA's excellent Chairman, Prof Sir Alasdair (that's D-A-I-R) Breckenridge, regarded the Yellow Card scheme as "an important way that the MHRA monitors drug safety." Back in January, 2005, when Prof Breckenridge gave this thunderous endorsement of the reporting scheme, the Health Minister, Lord Warner, was announcing the publication of anonymized data, taken from Yellow Cards, on the MHRA's website, thus permitting public scrutiny, and access to data for the purposes of further research.

But I think it's worth taking another look at the view of Prof Alasdair (that's D-A-I-R) Breckenridge. We've already established that the Yellow Card scheme is important in providing fresh data on side effects, post-licensing. The MHRA, which has as its primary goal the protection of the public from shite medical products, lest we forget, has told us that this is true, in the person of its Chairman. I just thought I'd reiterate that.

In fact, the MHRA regarded the Seroxat Yellow Cards as so important that Prof Breckenridge claimed that

"...in the appropriate... in the appropriate cases, this is... these patients are followed up. The follow up rate for Yellow Card reports is some 48% - 49%."

That quotation is taken from the transcript of the Panorama programme Taken on Trust, a precursor to Secrets of the Drugs Trials. And, yes, he really did struggle as much as those ellipses suggest (no, they don't indicate that I have edited his words!). I should say that I'm not quite clear as to whether Breckenridge is referring to Yellow Cards in general, or Seroxat suicide reports, when he advises Shelley Jofre that 49% are followed up.

So, we have euphemisms. We have semantics. We have poor follow up - certainly in the case of Seroxat suicidality reports, and, I suspect, more generally. Indeed, I filed a Yellow Card myself, consequent to suicidal ideations experienced when I took fluoxetine. I received a hard copy of the report, and I've heard nothing since. This patient regards that as unforgiveable.

The MHRA is four years old.

Matt

"FOI Review - Seroxat"

My latest jolly exchange with the MHRA, copied to Alan Johnson (the incumbent Secretary of State for Health, though for how much longer is debateable), Shailesh Vara (my MP), and the Information Commissioner's Office:

Dear ,

I have received your letter and attachments of 10 July, and I would respond as below. However, please be clear that while you have identified this series of communications to concern Seroxat, they at least equally concern the MHRA's conduct, with Seroxat being used as a case study:

FOI 07/040 - my request of 1 February and the MHRA's response of 21 February

I understand that there is a limit to the information that the MHRA is able to provide, in the context of an ongoing investigation. Having looked at this question in conjunction with the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), I have come to the conclusion that the information made available to the public is scant - it is difficult to establish a reasoned view of the conduct of the Company, even where one assumes that the 2004 Regulations apply in terms of the bar on retrospective application. The extent to which the MHRA wishes to publicize its belief that the Company has complied with the relevant legislation in certain respects, whilst continuing to investigate other areas, would be a matter for the MHRA.

FOI 07/104 - my requests of 27 March and the MHRA's response of 23 April

I raised several questions in my emails, most of which have been dealt with, although I do have a couple of outstanding queries. Thus, I am still unclear as to what the Company considered "significantly more affective" to constitute. Mr Fawbert suggested that I contact the Company for this information, which I have done, on several occasions. However, the Company appears unwilling to communicate with me, though I can't imagine why. As such, I would be keen for the MHRA to approach the Company, because I would be keen to understand what the Company thought the benefit of the drug was, if only in the US. Presumably the MHRA has the authority to compel a response - if it doesn't, I would be grateful if you could clarify that, because I would be keen to have a more complete understanding of the limits of the MHRA's authority.

Also, given the lack of information in the public domain, mentioned above, I am disappointed to note that where a member of the public wishes to conduct his/her own investigation into the conduct of a company or its regulator, (s)he will be precluded from doing so, with the FOIA being cited as authority.

FOI 07/105 - my request of 30 March and the MHRA's undated reply

It is reasonably clear from the MHRA's reply that it felt the Government had taken the appropriate course. However, with respect, I asked what the MHRA's response was to the allegations made by the HSC, and not the Government's. Also, while the legislation is no doubt rigourously drafted, at all times, I don't imagine that any regulator is precluded from introducing additional procedures where it perceives a need.

I believe I am correct in stating that the MHRA has no written internal procedures, nor does the MHRA publish and enforce an industry Rulebook, for the benefit of its members? For what it's worth, if I am correct in this understanding, then I consider this to be an appalling state of affairs. I believe I am also correct in stating that I asked for detailed information concerning the way that assessments were carried out (in a separate request, which it does not appear that you are considering in your review). As to the first point, I am keen to understand why? As to the second point, I believe this to be critical in my understanding of the MHRA's commitment to safeguarding public health.

In short, I believe it appropriate that I should be permitted to understand the rules that the MHRA purports to operate by. I fail to understand the secrecy.

FOI 07/130 - my request of 24 April and the MHRA's response of 22 May

I accept the explanations put forward by Mr Fawbert, concerning the changes to the PIL. However, you will note, perhaps, that this ties in with the question concerning the withholding of trials data, touched upon in FOI 07/040. Dr Benbow's comments are at odds with the 1998-2000 UK exercize, which Mr Fawbert mentions in his response to FOI 07/104, and with the Company's internal dialogue, dated October, 1998. I was interested to undersand whether the MHRA, as regulator, concerned itself with this incongruence, a point also covered under FOI 07/140?

FOI 07/131 - my request of 23 April and the MHRA's response of 22 May

I believe I sent a follow-up mail to Mr Fawbert's reply (indeed, I imagine I tend to regard these things as a dialogue, rather than simple, one-off requests for information, as you will probably have noted), in which I suggested that, owing to the risk of suicide, it would be appropriate for the largescale study mentioned to be carried out. As I recall, I also took issue with Mr Fawbert's claim that suicide was symptomatic of depression, or that depression causes suicide.

Perhaps the MHRA regards this as a semantic argument, but depression does not cause death in the same way that cancer does, as such I am still struggling to understand the acceptance of the increased suicide risk acknowledged to be created by Seroxat, given the apparent absence of an identified benefit.

Incidentally, the link that Mr Fawbert provided, for further information on the Licensing process (http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=102), does not appear to work.

FOI 07/140 and 142 - my request of 29 and 30 April and the MHRA's responses of 3 May

My queries concern Dr Benbow's claims, my wish to understand why these are so clearly at odds with official perception of the risks and with my ongoing concern regarding the absence of any clear definition of "efficacy" or "benefit", as those words pertain to Seroxat. I am concerned that such key questions were stonewalled.

I believe that is everything, aside from the issue of "vexatious" requests. Mr Goldfinch may not have understood where I was going with my enquiries, but then he should have asked, shouldn't he? He is a public servant, much as Mr Johnson is. "Another to go to Mr Holford"? Perhaps Mr Goldfinch would not be so flippant, if he understood better what I had experienced, coincidental to SSRI useage?

Best regards



--------------------------------------------------------------------------------
From:
To:
CC:
Subject: FOI Review - Seroxat Date: Mon, 9 Jul 2007 12:22:06 +0100
Dear ,

I have now managed to locate your earlier FOI requests on our database. There are 12 requests, 10 of which relate to Seroxat. Of these 10, 7 have been replied to and it appears that you have not received a reply to 3 of the requests.

Your email of 22 June 2007 raises a number of complaints about the MHRA's failure to provide you with some of the requested information. As you may appreciate, it would be very difficult to conduct an effective review of the MHRA's responses to your requests based on general complaints, nor would I want to run the risk of linking your complaints to the incorrect FOI requests. I propose, therefore, to send you hard copies of your requests and the responses sent to you from the MHRA. I will not send you papers relating to the 3 requests for which you have not received a reply, however, I will address these in my review.

I would be grateful if you could consider your requests and the replies received and then identify the specific areas that you would like reviewed. Grounds for review may include the failure to answer a question, or disagreement with the application of a FOI exemption applied etc.

Could you please provide me with your postal address so that I can send you the hard copies.

Many thanks,

Overdue update...

Well, quite a lot has happened, since I started this blog. I was having difficulty logging on, for some reason, and I lost interest, which explains the lengthy gap in between the first post and this one.

Anyway, I've been writing a couple of things for Bob Fiddaman's Seroxat Sufferers, which you may be interested in taking a read of: http://fiddaman.blogspot.com/search/label/Matthew%20Holford%20Rant, and which will probably give you a fair understanding of what I've been up to. I quite enjoyed writing the Marty Keller series, even though it's old ground. I should mention that those mentioned in the various pieces were given advance warning of publication, and were invited to comment. Nobody did, not surprisingly.

I've also engaged in quite a lengthy exchange with the MHRA. I'll include my most recent exchange under a separate post, but the upshot is that my correspondence with them was truncated by some jobsworth by the name of Richard Goldfinch, who branded my queries as "vexatious". In reprise, I raised several complaints, which are supposedly being investigated by the MHRA, even as I write this.

Also, I've been spending a bit of time on the Uncommon Knowledge fora. I still haven't worked out why people perceive the need to take drugs for their problems, but there you go. Oh, this'll make you laugh, my ex-employer sent the police round to my house, alleging that I was harassing it (I'd copied it in on some emails to various MPs, including mine, where the subject matter touched upon its behaviour). I told the PC who attended that, amongst other things, Albourne Partners Limited, for such it is, had the most dubious attitude towards anti-money laundering legislation, and a peculiar approach towards employee relations, generally. We agreed that I would only pursue my allegations, if Albourne felt inclined to pursue its allegations against me. I await further intelligence with great eagerness!

Anyway, I'll post the latest from the MHRA, and I promise to keep things up-to-date, from now on.

Matt