Tuesday, 18 August 2009
Sunday, 12 July 2009
Conclusion of Informal Correspondence
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I received no replies to my last two emails, however, I did receive two read receipts for each so presume that Mr Gregor and M-s Smith both read them, the receipts can be published if anyone wants to see them; as I did not receive any guidance from the MHRA with regard redactions the emails have been published in tact other than redaction of my details.
I will answer the hovering question - “why redact my details?”
Quite simply I don’t see the need for them to be there, if a question or issue is raised that is pertinent and of concern to the wellbeing of the whole population – who asks that question or raises that issue is immaterial - as long as they're asked and raised.
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Also - I have no vested interest for personal or financial gain in collecting or disclosing facts and information.
I did not become involved with the prescription drug boards or any other issue for self promotion – something another person involved just can’t seem to get their head round.
Although from what has transpired since I published my first Blog “Tuesday1st UK: SSRI / SNRI Antidepressant Statistical Politics” and my name was brought into the MHRA PPES arena - his 'need' to know personal details is blatantly nothing to do with the subjects raised.
Now the informal correspondence between Mr Gregor and myself have been published,
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once Mr Gregor is back in office I intend, on a more formal footing, to raise with him the areas and issues of concern referred to in my opening post and acceptance; these will cross link to dialogue already instigated with pharmacovigilance and FoI questions I have asked.
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NB – Before someone passes comment. I know there is an error in my last email which should have read Correspondence not ‘Conversations’, there are others too throughout the correspondence, but that’s dyslexia for you!
From: Gregor, Simon - Sent: Friday, June 05, 2009 11:27 AM - Subject: Out of Office AutoReply: Patient and Public Engagement
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As it was by then Friday, after receipt of the out of office notice and being concerned about publishing the informal emails without Mr Gregor knowing; I called Mr Gregors colleague and spoke with her about the situation, she read the email I directed her to, sent me a read receipt, marked the email urgent to ensure Mr Gregor would notice it.
He called a little later that day and we discussed the situation; as our contact at this point was on an informal basis this call will not be transcript or published.
As it was by then Friday, after receipt of the out of office notice and being concerned about publishing the informal emails without Mr Gregor knowing; I called Mr Gregors colleague and spoke with her about the situation, she read the email I directed her to, sent me a read receipt, marked the email urgent to ensure Mr Gregor would notice it. He called a little later that day and we discussed the situation; as our contact at this point was on an informal basis this call will not be transcript or published. During the conversation it was mutually understood that our correspondence thus far was informal, that I was reluctant to publish - but felt I had been left no choice. Mr Gregor seemed to appreciate my making contact to inform him of my intention to publish, rather than him just coming across the Blog or having it brought to his attention by a third party.
Our conversation ended on the gist that although the correspondence thus far was informal the decision whether to publish was left to my discretion as to whether I felt it necessary. Because of my reluctance about publishing I decided to stalled to see if the internet situation resolved – which it didn’t - if anything it escalated.
Saturday, 11 July 2009
Sent - Date: Friday, June 5, 2009 11:27 AM - Subject: Re: Patient and Public Engagement
Attachment
Dear Mr Gregor
As Mr Bob Fiddaman has seen fit to escalate his targeting of me, and done exactly what I predicted and informed you he would do in my email of May 22nd 09–
“Again, I stress, I am not asking you to comment - but I do need to question your discernment in discussing matters with Mr Fiddaman and by doing so giving him license to put others (including myself) in a compromised situation that he can - and will use for further self promotion and / or castigation - depending whether those put forward choose to work with you - or not.”
by posting the following
http://tuesday1st.wordpress.com/2009/06/03/delusional-anti-seroxat-campaigner-rants/
“See minutes of meeting Bob Fiddaman had with MHRA.
Ask yourself why Mardi Bennett refuses to acknowledge that the meeting was about ALL SSRi’s.
Bennett has been offered the chance to meet with the MHRA, in fact, it was Bob Fiddaman who recommended they speak with her. It is not known if she has the balls to face them face to face. I’m sure if she ever does she will repeatedly harp on about the ’single issue of Seroxat’.
Mardi Bennett continues to rant and rave about Seroxat campaigners, despite evidence that her fixation, Bob Fiddaman, has tried to make changes with ALL SSRi’s.
Is it because the minutes to the MHRA meeting do not fit in with her blinkered views that she still continues in her quest to fit peices of a jigsaw together that aren’t actually there?”
on a blog he has started specifically for the purpose on June 2nd 09
http://tuesday1st.wordpress.com/
after I wrote an explanatory post , June 2nd 09, uksurvivors group due to concerns about another person - “Steve” – who had become involved and had been directed by Mr Fiddaman to read there -
http://groups.yahoo.com/group/uksurvivors/message/44709
“Steve” - obviously uneducated in the arena he had been baited into by Mr Bob Fiddaman, of his deleterious reputation and calculated, devious manipulation was probably expecting --after complying with a request for more information to “put the records straight” -- the posts about the family to be removed - NOT just edited!
Stressing again that I am not asking you to comment, but being aware that you are following the Blogs and therefore Mr Bob Fiddamans activities -,I refer you to the following two Blogs
http://strangfordbryce.blogspot.com/
http://jeremybryce1953.wordpress.com/
which he has claimed ownership of by way of stating he was editing one: -
http://farm4/. static.flickr. com/3601/ 3586075255_ 55b2b82a04_ o.jpg
where he has targeted others family members and myself.
In direct response to a question from another member of the Yahoo groups I posted the following on June 3rd 09
http://groups.yahoo.com/group/uksurvivors/message/44782
when I didn’t receive a response by the following day, June 4th, I copied it to two other boards I knew the questioner posted on, including the one “Steve” had been directed too.
Mr Fiddamans vitriolic attack --including his starting his Tuesday1st blog-- I feel leaves me no option but to publish our correspondence to clarify my position, either on my blog or on a more permanent fixture; Where if taken forward will be a public record befitting discussions related to the MHRA Public and Patient Engagement Strategy (PPES).
I appreciate the privacy aspect of this decision, but trust this will not be met with any objections as all correspondence about the MHRA PPES, can be requested under the Freedom of Information Act, used and quoted -- usually out of context -- by others.
I would also appreciate your letting me know if there is anything you would like redacted from our correspondence before it is published, which I plan to do at the weekend.
Kind Regards
Redacted
From: Gregor, Simon
To: Redacted
Sent: Tuesday, May 29, 2009 12:28 PM
Subject: RE: Patient and Public Engagement
Friday, 10 July 2009
Thursday, 9 July 2009
Wednesday, 8 July 2009
Tuesday, 7 July 2009
Friday, 3 July 2009
Introduction: PPES invitation acceptance, decision and reason to document correspondence with the MHRA
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After a great deal of consideration, written and verbal consultation with the Mr Simon Gregor the Medicines and Healthcare products Regulatory Agency (MHRA) Director of Communications – I am publishing the following correspondence between him and myself.
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The Patient and Public Engagement Strategy (PPES) is - as its title states – an official contrivance to engage Patients and the Public – therefore of Patient and Public interest.
Without passing any judgement on Simon Gregor or the MHRA, I still don’t really see how the PPES - a public relations (PR) exercise - is going to improve the areas of medicines control and the efficacy and safety of the drugs being licensed.
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However, as Simon Gregor has eloquently stated in his correspondence, he see’s the function of the MHRA communication department as much about listening, as it is about disseminating information;
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in theory this is commendable, but I feel some apprehension insofar as – unless there is a major shift in the industry devised regulatory paradigm the MHRA work under at present –
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and changes in Government legislated regulations which facilitate the MHRA - and therefore the industry it self-regulates, free reign without any official checks and balances, and answerable to no one –
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there will be little improvement in the service and protection it affords patients, in prescription drug safety and efficacy monitoring, and no protection or channel for recourse or recompense when things go wrong - and things do go wrong.
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This is a fact NICE(1), the MHRA, NHS and Government are acutely aware of and freely admit to - as all medicines are registered, licensed and monitored for efficacy and safety on the merit of risk-benefit profile ratios.
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There are several areas where there appear to be opportunities for improvement in the current system, unless these are explored and avenues opened to facilitate change the situation will stagnate and patients will remain in the same vulnerable circumstance.
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As Simon Gregor has offered the opportunity for discourse I have -- after deliberation -- written and accepted his invitation to discuss these issues with him, however, due to my health limitations and time restrictions meeting on a personal basis will not be possible at this time;
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so am doing so on the understanding that current discussions will be carried out through the written medium or by telephone, and all correspondence and transcripts of telephone calls / discussions will be published here for open public record.
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This will raise public awareness to areas of concern within the medicine regulatory system, give a record of the level of commitment to involving Patients and the Public and hopefully show that those areas of concern can and will be improved -– or not as the case may be.
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Publishing this correspondence will also offset others unnecessarily engaging the MHRA FoI (Freedom of Information) department with requests for information, stop erroneous speculation or resulting replies and items being quoted out of context, misinterpreted and otherwise exploited.
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Having discussed with Simon Gregor publishing our informal introductory basis correspondence thus far, I would like to make point that they are only being published to put the records straight with regard the current circumstance;
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whereby the contemptuous, disrespectful activities of Mr Bob Fiddaman of the fiddaman.blogspot continues – along with his stalking and harassment, in an attempt to undermine, intimidate and discredit me - for some warped perverse reason known only to himself.
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Whilst eager to involve Patients and the Public, the MHRA being aware that the situation has arisen in part due to their involvement, appear to have done nothing to assuage the situation, despite that involvement being used as ammunition in the unfounded, vitriolic if fanciful, venomous attacks.
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In taking up this opportunity for discussions with the MHRA I am under no illusions - but feel it would be prudent for other Patients and members of the Public to approach any PPES(2), PPIP(3) with caution and consideration to a lack of concern by and support - if need arises - from the lead organisations.
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Acronyms:
1 The National Institute for Clinical Excellence
2 Patient and Public Engagement Strategy
3 Patient and Public Involvement Program
Sunday, 21 June 2009
MHRA: Communications Strategy
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Communications Strategy
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Progression and development of the MHRA Communication Strategy following it’s Summer 2005 introduction after publication of The "House of Commons, Health Committee’s examination into The Influence of the Pharmaceutical Industry" - initiated June 2004 - report published April 5th 2005.
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http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
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MHRA Communications Strategy Summer 2005- April 2007: an Agency-wide approach to communication.
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“The MHRA is responsible for safeguarding public health by making sure that medicines and medical devices work, and are acceptably safe. If it is to be successful in this mission, the Agency must effectively communicate accurate and timely information about the benefits and risks of medicines and medical devices to key stakeholders, including the public, patients, healthcare professionals, researchers and industry.
Communications is therefore mission critical for the Agency. In 2005, the new Communications Division drew together a first communications strategy for the Agency. There have been significant improvements in the Agency’s communications through the implementation of this strategy, particularly in relation to:
- media handling, including the creation of an in-house Press Office
- website development, including the launch of a single unified website
- understanding stakeholder needs, including commissioning of detailed market research work to help us understand better the perceptions of our stakeholders
- conferences and events.”
Communications Strategy April 2007 – March 2010
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“Our second Communications Strategy, covering the period until March 2010, briefly reviews the current situation in relation to Agency communications, and the evidence informing future development. It sets out the wider business context for communications activity, before establishing aims, priorities and actions for the three-year period.”
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Patient and Public Engagement Strategy April 2009 - March 2011
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“The MHRA has embarked on a new programme of activity to engage patients and the public in its work and the decisions it makes. The Agency’s first Patient and Public Engagement strategy, covering the period until March 2011, sets out the vision and strategic priorities in this area, and identifies a range of activities that will help build the Agency’s capacity and capability to successfully engage with patients and the public.”
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http://www.mhra.gov.uk/home/groups/comms-sp/documents/publication/con041519.pdf
Saturday, 20 June 2009
MHRA: Medicines and Healthcare products Regulatory Agency
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“Medicines and Healthcare products Regulatory Agency:
An executive agency of the Department of Health
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We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.“
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http://www.mhra.gov.uk/index.htm
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“Who we are
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The MHRA was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
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The MHRA is an executive agency of the Department of Health.”
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http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm
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“About us
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- The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
- No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
- We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem.
- We aim to make as much information as possible publicly available.
- We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public.
- We encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.”
http://www.mhra.gov.uk/Aboutus/index.htm
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”Our mission and values
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The MHRA's mission and values.
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The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.
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Values
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In pursuing our mission we will strive to act with:
- integrity;
- openness;
- courtesy;
- responsiveness;
- timeliness;
- professionalism;
- impartiality; and
- consistency.”
http://www.mhra.gov.uk/Aboutus/Whoweare/Ourmissionandvalues/index.htm
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"Our aims and objectives
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The MHRA's aims and objectives.
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Aims
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Our aims are:
- Protecting public health through regulation, with acceptable benefit-risk profiles for medicines and devices.
- Promoting public health by helping people who use these products to understand their risks and benefits.
- Improving public health by encouraging and facilitating developments in products that will benefit people.
Objectives
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Our strategic objectives are to:
- safeguard public health through our primary role in ensuring that the products we regulate meet required standards, that they work and are acceptably safe;
- carry out our communication role through the provision of accurate, timely and authoritative information to healthcare professionals, patients and the public;
- support research, ensuring through the application of Better Regulation principles that regulation does not stifle innovation;
- influence the shape of the future regulatory framework through use of our effective European and International relationships;
- run an organisation with a skilled and equipped workforce that is fit for the future."
http://www.mhra.gov.uk/Aboutus/Whoweare/Ouraimsandobjectives/index.htm
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"Our activities
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The MHRA's activities.
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Our main activities are:
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the
- overseeing the UK Notified Bodies that audit medical device manufacturers;
- operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;
- operating a proactive compliance programme for medical devices;
- operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;
- regulating clinical trials of medicines and medical devices;
- monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;
- promoting good practice in the safe use of medicines and medical devices;
- managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;
- offering scientific, technical and regulatory advice on medicines and medical devices; and
- providing the public and professions with authoritative information to enable informed dialogue on treatment choices.
These activities are supported by our ten divisions who are also responsible for: information management; providing executive support services; human resources; and finance."
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http://www.mhra.gov.uk/Aboutus/Whoweare/Ouractivities/index.htm
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"What we regulate
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The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering."
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http://www.mhra.gov.uk/Aboutus/Whatweregulate/index.htm
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"What we regulate: Medicines
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Whether it’s a medicine you buy, or one prescribed for you as part of a course of treatment, it’s reassuring to know that all medicines available in the
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But what is, and is not, a medicine?
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The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.
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Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says. Claims that a product “supports” health or a healthy lifestyle is not usually considered as medicinal.
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Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for."
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http://www.mhra.gov.uk/Aboutus/Whatweregulate/Medicines/index.htm
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"How we regulate
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How we regulate section.
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The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering. This section helps describe how the MHRA manages each of these products, including the use of nanotechnology in some of them.
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The main difference between how medicines and medical devices are regulated lies in how a product gets onto the market. All medicines are directly approved by the MHRA which issues a 'marketing authorisation', or licence. Manufacturers and distributors are also licensed directly by MHRA. Medical devices are approved by private sector organisations called 'Notified bodies'. Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA. The MHRA audits the performance of Notified Bodies. However:
- when a product is on the market and in use, there are more similarities than differences in the ways medicines and devices are regulated
- there are similar systems for receiving reports of problems with products and similar ways of issuing warnings if problems are confirmed after investigation
- there are also similar systems for inspection of manufacture to ensure that companies are complying with regulations, and similar ways of enforcing the law if that proves necessary.
Further information on how we regulate medicines and medical devices is available in our publication:
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› 'Medicines & Medical Devices Regulation: What you need to know'
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How we make regulatory decisions about medicines and medical devices
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The MHRA and other related organisations make a lot of regulatory decisions. After consulting with a range of stakeholders we have set out on five pages the main considerations that affect those decisions:
- the role of MHRA and the scope of the document
- the main regulatory decisions that are made about medicines and medical devices
- the principles that inform these decisions
- the questions that are considered to ensure that the decisions are reasonable
- who makes decisions about medicines and medical devices – which includes bodies other than MHRA.
A download version of the document is also available:
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› Making Regulatory Decisions about Medicines and Medical Devices"
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http://www.mhra.gov.uk/Howweregulate/index.htm
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"Our structure
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The MHRA' s main activities (below) are supported by our ten Divisions who are also responsible for: information management; providing executive support services; human resources; and finance.
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The MHRA's activities:
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the
- overseeing the UK Notified Bodies that audit medical device manufacturers;
- operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;
- operating a proactive compliance programme for medical devices;
- operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;
- regulating clinical trials of medicines and medical devices;
- monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;
- promoting good practice in the safe use of medicines and medical devices;
- managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;
- offering scientific, technical and regulatory advice on medicines and medical devices; and
- providing the public and professions with authoritative information to enable informed dialogue on treatment choices.
Corporate governance
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The following structures and processes are designed to ensure accountability and give the Agency a framework for risk management:
- The Agency Board is made up of a non-executive Chairman, six non-executive members and the Agency's Chief Executive Officer.
- The Agency's Chief Executive is responsible for service delivery and resources.
- The Executive Board, consisting of the Agency's directors, takes overall responsibility for day-to-day management, strategic decision-making, line management, and all financial, policy, operational and resource management issues.
- The Risk and Audit Committee provides independent feedback to the Chief Executive, who is also the Accounting Officer, and the Management Board on the effectiveness of our risk management processes. The Committee is supported by the Agency's Risk Management Team."
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