APPGITA

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire SK9 5AF

1 May 2013

Dear Sir/Madam,

I wish to appeal to the ICO against the refusal by the Department of Health FOI Internal Review reference IR 724555, dated 6 November 2012.

The over-arching reason for my appeal is the lack of public scrutiny of the momentous decisions by the DH Steering Group on addiction to medicines.

Part A is the background to my appeal and Part B is my appeal against the exemptions invoked by the Department of Health FOI team.

PART A Background

A long-standing public health problem of large scale addiction to prescribed tranquillisers has existed for nearly 50 years. Patients become dependent upon benzodiazepine and z drug tranquillisers prescribed to them by their doctors.

Withdrawal symptoms from tranquillisers can be intense, prolonged and debilitating with long-term users suffering multiple physical and psychological withdrawal symptoms which have caused sufferers the loss of ability to earn an income, loss of homes, break-ups of families and suicides. Long-term users can suffer a protracted withdrawal syndrome which is a cluster of withdrawal symptoms and also post-benzodiazepine withdrawal symptoms which can persist for months or years following dose reduction to zero.

An estimated 1.5 million people have been prescribed these drugs long-term, some for decades, with no NHS treatment available. This estimate is based upon a survey carried out by BBC Panorama in 2001 for a programme called “The Tranquilliser Trap and is also written in ‘Drugs Education Prevention and Policy’ Vol 9 Pt 4 Benzodiazepines: addiction and cause published in 2002 co-written with Mark Ashworth, Rebecca Dallmeyer and Clare Gerada, Chair of the Royal College of General Practitioners, an extract of which reads “there are an estimated 1-1.5 million long-term users”

Although dependence has been caused by the National Health Service there is next to no treatment provided nationally by the NHS as shown by my survey, entitled “Survey of PCTs in England recording provision of services for involuntary tranquilliser addiction” (Attachment 1)

Decades of campaigning made a succession of health ministers aware of a substantial prescribed tranquilliser problem with no effective government policy. The All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) was formed in 2008 and is chaired by Jim Dobbin MP. To declare my interest, I am a supporter of APPGITA and provide unpaid research for the group; my constituency MP, Eric Ollerenshaw, is a member of APPGITA.

The APPGITA’s use of the term “involuntary” is deliberate in order to differentiate prescribed tranquilliser addicts from illegal drug users and substance misusers.

Tapered withdrawal from tranquillisers can take up to a year or more and require specialist advice and support. Abrupt withdrawal is dangerous and potentially life threatening. Withdrawal services have been provided by a handful of withdrawal charities nationwide which are successful in tranquilliser withdrawal. However, most dependent patients do not present for addiction treatment because they remain hidden, largely unaware that they have a problem. Also, their doctor is unlikely to tell them as to do so would expose their prescribing errors.

The main causes of involuntary tranquilliser addiction (ITA) are:

1. Doctors ignoring guidelines issued in 1988 by the Committee on Safety of Medicines which states that “Benzodiazepines are indicated for the short-term relief (two to four weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia.”

Patients were placed on these drugs by their GPs without proper warnings or information and they developed an addiction due to poor prescribing and monitoring by their doctors. Patients have been left on these drugs for months, years and in many cases decades.

The DH has been aware that these guidelines have been ignored and has taken no appropriate action.

2. Regulatory failures by the Medicines and HealthCare Products Regulatory Agency, (MHRA) and its predecessors, the main ones of which are as follows:

Tranquillisers were granted Licences of Right under the Medicines Act 1968, without assessment for safety or efficacy. Following this, a plethora of new tranquilliser licences continued to be issued by the MHRA referring back to these original licences, again with no assessment for safety or efficacy. There are currently 173 products authorised in the UK containing benzodiazepines and 47 Z-drug licences (Z- drugs are similar to benzodiazepines). By comparing data sheets with those of other countries it is evident that warnings regarding withdrawal symptoms and addiction were and remain significantly lower than for example, Australia, Canada and the US, and in some cases warnings were absent entirely from UK data sheets.  The MHRA does not answer questions on the safety of tranquillisers or the accountability of the pharmaceutical manufacturers due to lost or destroyed files; the MHRA routinely destroys all clinical trial data after 5 years.

APPGITA’s main aims have been to raise awareness of the issues and lobby government departments including the DH and the MHRA to take appropriate action, including the recognition of ITA as a condition and not a substance misuse issue, the provision of appropriate dedicated withdrawal services with drug free goals, to ensure compliance by doctors with guidelines and adequate regulation by the MHRA, including a review of drug licences and the strengthening of warnings on data sheets to international standards.

In July 2009, Gillian Merron MP, then Public Health Minister, announced a DH review of policy on addiction to prescribed drugs.

A Steering Group was appointed within the DH in 2010 to oversee policy on addiction to medicines. The function of the group, job titles and some members names were given in the following answer to a Parliamentary Question on 6 December 2010:

“Eric Ollerenshaw: To ask the Secretary of State for Health what the (a) names, (b) job titles and (c) qualifications are of the members of his Department’s Steering Group of officials in respect of the review of prescription drug addiction. [27945]

Mr Simon Burns: The membership of the Steering Group to oversee the policy on addiction to medicines takes account of all the relevant policy areas within the Department and its arm’s length bodies. It includes officials and experts representing drugs policy, mental health, pharmacy issues, the National Treatment Agency for Substance Misuse and the Medicines and Healthcare products Regulatory Agency.

In line with Freedom of Information rules the Department’s policy is that the names of officials should be withheld from disclosure unless they are members of the senior civil service or have a high profile that would justify release. The names have therefore been edited accordingly.

There are six other members of the Steering Group below senior civil service level”

The job titles and organisations of the six members below senior service level were revealed in a reply to a further Parliamentary Question by my MP on 26 January 2011, however their identities were withheld under Section 40 exemption, which I also wish to appeal against and which I address later in this letter.

“Eric Ollerenshaw: To ask the Secretary of State for Health pursuant to the answer of 6 December 2010, Official Report, column 1285W, on departmental manpower, what the (a) organisations and (b) job titles are of the six members of the Steering Group below Senior Civil Service level. [35857]
26 Jan 2011: Column 373W

Anne Milton: The following table gives the details of the organisations and job titles of the six members of the steering group below senior civil service level:

28 Feb 2011: Column WA245

It was thus established that the Steering Group comprised of officials from the MHRA, the DH and the National Treatment Agency for Substance Misuse.

Chronology of my FOI request and Internal Review

I sent the DH a FOI request on 9 September 2012. This request was sent by the DH website’s contact form and I therefore do not have the original email.

I received a refusal from the DH FOI team on 5 October 2012; I sent an appeal on 10 October 2012 and; I then received a refusal by the DH Internal review on 6 November 2012.

The full exchange of correspondence is as follows:

1. FOI request to the Department of Health on 9 September 2012:

“In answer to the Parliamentary Question below correspondence is mentioned. I wish to make an FOI request for that correspondence and also any minutes taken at the 5 May 2011 meeting.

Prescription Drugs: Misuse

Jim Dobbin: To ask the Secretary of State for Health with reference to answer to the hon. Member for Lancaster and Fleetwood of 6 December 2010, Official Report, column 80W, on departmental manpower, on what dates the Steering Group met to oversee the policy on addiction to prescribed medicine; who the attendees were at each of those meetings; what the present membership of the group is; and what future meetings the group has scheduled. [119034]

Dr Poulter: The Department’s steering group on addiction to medicine met on 18 August 2010, 1 February 2011 and 5 May 2011. Additional discussions took place between meetings, and since the most recent one, by correspondence. No face-to-face meetings are currently scheduled. The policy areas represented were as set out in the answer of 6 December 2010, Official Report, column 80W and the membership of the steering group by officials in the senior civil service has not changed. At the first meeting officials at grades below the senior civil service represented the Medicines and Healthcare products Regulatory Agency.”

2. The DH refusal on 5 October 2012: (Attachment 2)

Our ref: DE00000724555

Dear Mr Perrott,  

Thank you for your FOI email request of 9 September to the Department of Health.    

Your exact request was:

“In answer to the Parliamentary Question below correspondence is mentioned. I wish to make an FOI request for that correspondence and also any minutes taken at the 5 May 2011 meeting.

Prescription Drugs: Misuse

Jim Dobbin: To ask the Secretary of State for Health with reference to answer to the hon. Member for Lancaster and Fleetwood of 6 December 2010, Official Report, column 80W, on departmental manpower, on what dates the Steering Group met to oversee the policy on addiction to prescribed medicine; who the attendees were at each of those meetings; what the present membership of the group is; and what future meetings the group has scheduled. [119034]

Dr Poulter: The Department’s steering group on addiction to medicine met on 18 August 2010, 1 February 2011 and 5 May 2011. Additional discussions took place between meetings, and since the most recent one, by correspondence. No face-to-face meetings are currently scheduled. The policy areas represented were as set out in the answer of 6 December 2010, Official Report, column 80W and the membership of the steering group by officials in the senior civil service has not changed. At the first meeting officials at grades below the senior civil service represented the Medicines and Healthcare products Regulatory Agency.”

“I can confirm that the Department does hold some of the information you have requested. However, please be aware that under Section 35(1)(a) of the FOIA, information held by a Government Department is exempt from release if it relates to the formulation or development of policy.

The purpose of Section 35 of the FOIA is to protect the internal deliberative process, which is a key part of all policy making. We consider that the discussion at the meeting on 5 May 2011 and the correspondence between members of the official steering group is exempt under section 35 on the grounds that it relates to on-going policy development, that is, the monitoring, reviewing, and analysing of existing policy.

Section 35 is a qualified exemption, which requires careful consideration of the public interest. In applying this exemption, we have had to consider the public interest in maintaining the exemption against the public interest in disclosing the information.

The Department recognises a general public interest in promoting openness. However, the purpose of the exemption at s35 of the Act is to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Premature disclosure of information protected under section 35 could prejudice good working relationships, the neutrality of civil servants and, ultimately, the quality of Government.

Additionally, releasing this information could lead to further requests that may inhibit the debate and exploration of the full range of policy options in this area, and could result in putting the Department into the position of having to defend everything that has been raised (and possibly later discounted) during deliberation.

We are therefore withholding this information under section 35.”

3. My appeal of 10 October 2012 against this refusal by requesting an Internal Review: (This was sent by the DH website’s contact form and I therefore do not have the original email)

“I wish to appeal against this decision for the following reasons:

1. The significance of decisions made by the Steering Group will affect the health of an estimated 5 million long-term users of drugs prescribed by their doctor who have no exit route from these drugs; these include an estimated 1.5 million long-term users of prescription tranquillisers and an estimated 3.5 million long-term users of SSRIs and antidepressants.

2. There is no ongoing policy development as the main decisions have been made by the Department of Health, and these were made prior to my FOI request and they are as follows:

a) The transfer of responsibility for addiction to medicines from the Department of Health to the NTA in August 2012 including funding arrangements directed by the NTA in many documents including the JSNA support pack.

b) The final draft consensus statement by 7 September 2012. This document will not be altered as made clear to round table members in an email from Steve Taylor of the NTA.

c) The transfer of responsibility for provision of services for addiction to medicines from the Department of Health to local authorities under the Health Bill.

3. Citing “monitoring, reviewing, and analysing of existing policy” would prevent disclosure of any information permanently and is unreasonable.

4. The Steering Group comprises Senior Officials who should be able to explain and defend their views.

5. The policy review on addiction to medicines was conducted in secrecy. Round table members were bound by the Department of Health to confidentiality agreements and told not to discuss anything outside the group. There were no benzodiazepine tranquilliser experts on the round table.

6. The Department of Health throughout the three year review, consultation, round table and consensus ignored the advice of experts, ignored evidence when presented to it, including my survey which proved the NTA report was factually inaccurate, excluded anyone presenting evidence supporting any view different to its own, including the All Party Group for Involuntary Tranquilliser Addiction, chaired by Jim Dobbin MP and Professor Ashton, a recognised expert.

In fact, FOIs became a major source of information on this issue for the APPGITA due to the secrecy in which the Department of Health conducted the policy review. There were no minutes or agendas for Ministerial meetings.

Therefore, there has been no political scrutiny of the momentous decisions made by the Steering Group.

The result of all the above will be a reckless experiment endangering the health of an estimated 5 million people stuck on these drugs with no exit route and the public interest far outweighs the Section 35 exemption.”

4. The Internal Review refusal dated 6 November 2012: (Attachment 3)

“The Review

We have carefully considered our handling of your original request and continue to maintain that s. 35 (1) (a) of the FOIA is engaged to withhold the information.

I should re-iterate that s.35 is a qualified exemption, which requires consideration of the public interest. In applying this exemption, we have had to consider the public interest in maintaining the exemption against the public interest in disclosing the information.

The Department recognises a general public interest in promoting openness. However, we consider that the s. 35 exemption is engaged correctly. In continuing to withhold the information, we want to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Premature disclosure of information protected under section 35 could prejudice good working relationships, the neutrality of civil servants and, ultimately, the quality of Government.

The material relates to comments as part of a peer review process, which the All-Party Parliamentary Group on Involuntary Tranquiliser Addiction (APPGITA) considered – and should not be disclosed – as it would fundamentally undermine the peer review process and future quality of independent commentary and reports.

Additionally, releasing this information could lead to further requests that may inhibit the debate and exploration of the full range of policy options in this area, and could result in the Department in having to defend everything that has been raised (and possibly later discounted) during deliberation.

We have consistently engaged with the APPGITA and have only withheld information requested under the Freedom of Information Act when this has proved necessary.

We have already made a wide range of information on the topic publicly available, including previous responses to you and in particular your requests DE 614879, DE 624554, DE 624521 and DE 708103. Please let me know if you require copies of these replies.

You raised a number of specific points in your request for an Internal Review.

I will deal with them point by point:

1. The significance of decisions made by the Steering Group will affect the health of an estimated 5 million long-term users of drugs prescribed by their doctor who have no exit route from these drugs; these include an estimated 1.5 million long-term users of prescription tranquillisers and an estimated 3.5 million long-term users of SSRIs and antidepressants.

You are correct that the topic was the subject of a Parliamentary question and answer in the House of Commons, which is available in the Hansard Official report for 6 December 2010 at col 80w on the www.parliament.uk website.

As such, some information is already in the public domain. Clearly, this is a point the Department of Health took into consideration previously in its original reply to you on 5 October by way of the balance of the Public Interest Test (PIT).

The significance of the issue also underlines why it is important that decisions are soundly based, which is why we need to protect the policy-making process under s.35 (1) of the FOIA.

2. There is no ongoing policy development as the main decisions have been made by the Department of Health, and these were made prior to my FOI request and they are as follows:

a) The transfer of responsibility for addiction to medicines from the Department of Health to the NTA in August 2012 including funding arrangements directed by the NTA in many documents including the JSNA support pack.

b) The final draft consensus statement by 7 September 2012. This document will not be altered as made clear to round table members in an email from Steve Taylor of the NTA.

c) The transfer of responsibility for provision of services for addiction to medicines from the Department of Health to local authorities under the Health Bill.

While there has been a change of personnel in the team, there has been no change to the basic principle that the Department is responsible for policy and the National Treatment Agency for Substance Misuse is responsible for supporting local service commissioning and delivery.

We confirm that the Department continues to develop policy in this area. The consensus statement to which you refer has not yet been formally launched.

The provisions in the Health and Social Care Act, which transfer responsibility for commissioning services to treat dependence from Primary Care Trusts to local authorities, do not remove from the Department the responsibility for policy development.

Nor does the Act alter the Department’s role in relation to service commissioning, which has been a local responsibility for many years.

3. Citing “monitoring, reviewing, and analysing of existing policy” would prevent disclosure of any information permanently and is unreasonable.

We disagree with your view that the description we used in our original response “monitoring, reviewing, and analysing of existing policy” means that the Department will prevent disclosure of any information it holds permanently.

The FOIA s. 35 (1) (a) provides that information deemed to be sensitive and withheld for policy formulation/development reasons will, due to the passage of time, require review on receipt of future requests under the Act.

It may well be that, with a sufficient passage of time, we would be content to release it at a later stage.

You will be aware from communications about the consensus statement, which you have seen that the Department is planning a public launch of that document.

As this demonstrates, the Department continues to seek to make a wide range of information available and therefore we now wish to engage the s. 22  exemption of the FOIA to exempt some of the information we are currently withholding under s. 35 (1) (a).

4. The Steering Group comprises Senior Officials who should be able to explain and defend their views.

By referring to the Parliamentary Answer on 6 December 2010, the answer you quote identifies the Senior Civil Servants who were at the meeting on 5 May 2011, therefore information about attendance at the meeting has already been released.

However, we are engaging s. 35 (1) (a) in relation to the substance of the discussion, not to the identity of the officials who have been named.

5. The policy review on addiction to medicines was conducted in secrecy. Round table members were bound by the Department of Health to confidentiality agreements and told not to discuss anything outside the group.

There were no benzodiazepine tranquilliser experts on the round table.

You are correct that it was agreed by participants at the round table that those discussions should take place in confidence.

I should explain that the Department did have two benzodiazepine tranquilliser experts (covering two services) in attendance at the two roundtable meetings. However, your FOI request relates not to the proceedings of the round table but to the proceedings of the official steering group – and that is a different forum.

6. The Department of Health throughout the three year review, consultation, round table and consensus ignored the advice of experts, ignored evidence when presented to it, including my survey which proved the NTA report was factually inaccurate, excluded anyone presenting evidence supporting any view different to its own, including the All Party Group for Involuntary Tranquilliser Addiction, chaired by Jim Dobbin MP and Professor Ashton, a recognised expert.

I am afraid that your comments here fall outside the scope of the Internal Review and we maintain that s. 35 (1) (a) is appropriate in this case.

In fact, FOIs became a major source of information on this issue for the APPGITA due to the secrecy in which the Department of Health conducted the policy review. There were no minutes or agendas for Ministerial meetings. Therefore, there has been no political scrutiny of the momentous decisions made by the Steering Group.

The result of all the above will be a reckless experiment endangering the health of an estimated 5 million people stuck on these drugs with no exit route and the public interest far outweighs the Section 35 exemption.

The evidence shows that successive Ministers have been open with the Chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Abuse meeting him and other parliamentarians, researchers and stakeholders connected with it on many occasions.

On 17 October, Ministers met the Vice Chair of APPGITA along with other colleagues.

In addition, there have been opportunities for Parliamentary scrutiny of this work when different aspects of the issue were discussed in the House of Lords. For example, on 23 June 2011, 30 November 2011, 29 February 2012 and 12 July 2012

These are available at the following website: www.parliament.uk

The review is now complete.”

During these exchanges I submitted a second FOI request on 19 October 2012 broadening the scope of my original one, which read as follows:

“Regarding my appeal IR 724555 I request minutes of all meetings of the Steering Group to be included and not just the meeting of 5 May 2011.”

I received a response (Attachment 4) on 16 November 2012.

In this response the Steering Group minutes of meetings on 18 August 2010 and another meeting on 1 February 2011 were released; the latter was heavily redacted under Section 35 and both had Section 40 redactions.

I also wish to appeal against these redactions.

Appeal

The overarching reason for my appeal is the lack of scrutiny of the momentous decisions made by the DH Steering Group on addiction to medicines.

The significance of decisions

The significance of decisions made by the Steering Group is that they have enormous implications affecting the health of an estimated 1.5 million long-term users of prescription tranquillisers.

Secondly, the decisions also affect a further estimated 3 – 4 million long-term users of SSRIs and antidepressants. Selective serotonin re-uptake inhibitors (SSRIs) are a class of drugs typically used as antidepressants in the treatment of depression, anxiety disorders, and some personality disorders. Similar to tranquillisers, withdrawal from these drugs often requires specialist help unavailable on the NHS and provided by a handful of charities nationwide. This estimate is based upon prescribing levels; in 2011 there were nearly 47 million prescriptions for SSRIs and antidepressants.

Thirdly, the decisions also affect a large population addicted to prescribed and over-the-counter codeine containing products including painkillers.

Therefore, the decisions made by the Steering Group affect the health of more than 5 million estimated long-term users of prescribed and over-the-counter drugs.

Lack of scrutiny

Steering Group:

As previously explained any meaningful review of addiction to medicines would need to include review of the two obvious causes of prescribed tranquilliser addiction which are:

a) Regulatory failures by the MHRA and its predecessors

b) Poor prescribing habits including non-compliance with guidelines for doctors prescribing tranquillisers issued in 1988 by the Committee on Safety of Medicines

The most recent FOI response of 16 November 2012 received after the Internal Review decision of 6 November showed that at the first Steering Group meeting of 18 August 2010, Chris Heffer ruled investigation of these main causes of ITA out of the review when he stated that:

“It would not encroach on the role of MHRA in licensing or pharmacovigilance, or clinical judgement of DH Pharmacy in prescribing…”

As this decision was taken in private at this meeting, APPGITA continued to engage in Ministerial meetings in the mistaken belief that a full review was still in progress addressing all the relevant areas, whereas in fact this was not the case.

Chris Heffer attended ministerial meetings with APPGITA but did not disclose his “encroachment “decision.

Anne Milton, then Public Health Minister and Earl Howe, Parliamentary Under-Secretary of State for Health (Spokesperson Health, House of Lords) continued to claim that these areas were under policy review. It is therefore doubtful as to whether either had been informed of these decisions by Chris Heffer.

NAC Report:

Two reports were commissioned in 2009 by the DH to inform the policy review, one from the National Treatment Agency for Substance Misuse and the other from the National Addiction Centre (NAC) at Kings College London.

A meaningful review would also need to address the scale of the problem i.e. numbers of people dependent upon prescribed tranquillisers; the effects of long-term use of tranquilliser and; the availability of support for those affected.

An email from a senior DH official (Attachment 5) was sent to Professor John Strang at the NAC on 6 October 2009 in which he was asked to produce a literature review and given four clear terms of reference:

“Dear John,

I have recently joined the drugs team at the DH leading work on a review into addiction to prescription and over-the-counter medicine. We would like to commission a literature review on the subject and one or two larger pieces of research at a later stage. The focus would be on addiction to benzodiazepines, hypnotics and codeine-based painkillers.

There are four issues which we are particularly anxious to address in the literature review:

a) how many people are truly dependent on prescription medicine? (an estimate of 1.1m Benzo addicts was made to the parliamentary inquiry on the subject recently but there doesn’t seem to be a firm statistical basis for the estimate;

b) What are the long-term health effects of dependence on Benzos, sleeping pills and painkillers;

c) What support is available for people suffering adverse effects from Benzo/ hypnotics/painkillers?

d) To what extent are doctors complying with prescribing advice? (are they contributing to the problem by repeat/over-prescribing?

We appreciate that there is a huge amount of literature on benzos. However, it would be really helpful if we could clarify the evidence base for claims made by campaigners before committing additional resources to support services. Under DH contract rules, we need to get a number of written quotes for the work. I’d be grateful if you could check with colleagues to see if anyone is interested in taking on the project. We’re would like to progress this work as soon as possible. I’d be grateful if you could get back to me. Please drop me a line or give me a ring if you need more information

Kind regards”

This email was obtained by a FOI request dated 30 November 2011 to King’s College London, where Professor Strang is Head of Addictions Department.

Without this FOI response, APPGITA would not have been aware that any terms of reference had been given to Professor Strang for his NAC report.

It is clear from this email that:

1. Professor Strang was given four clear terms of reference on 6 October 2009.

2. The DH was ready to provide funding support services and allocate resources.

The NAC review when published in May 2011 failed to follow any of these four terms of reference; this meant that the obvious causes of ITA were excluded from consideration in the Department’s policy review.

This important information only came to APPGITA’s attention as a result of previous FOI requests and demonstrates the need for transparency and disclosure.

Roundtable:

In September 2011, the DH convened a round table as shown in this Parliamentary Question dated 17 October 2011:

“Eric Ollerenshaw: To ask the Secretary of State for Health what steps he plans to take following his Department’s recent round table meeting on involuntary tranquilliser addiction. [73506]

Anne Milton: I convened a roundtable meeting of stakeholders on 15 September to discuss the future actions to tackle addiction to medicines. This included consideration of the specific actions required to:

1. Support GPs to respond to the issues of addiction to medicine.

2. Improve access to treatment and support.

3. Improve the commissioning of services to local need.

4. Increase public and professional awareness of addiction to medicines.

The Department will be publishing the list of agreed actions in due course and reconvening the stakeholders group to review progress in four to six months’ time.”

Members of the roundtable were selected by the DH and included officials from the DH, the NTA, the MHRA, and the Royal College of General Practitioners and the Royal College of Psychiatrists. Members also included service providers and service users, also selected by the DH.

One of the service users, Josh Jarrett, reported that it was not “agreed by participants at the roundtable that those discussions should take place in confidence” as stated in the Internal review, it was a condition imposed by the DH.

Roundtable members were bound by the Department of Health to confidentiality agreements and told not to discuss anything outside the group.

All four members of the Steering Group were also members of the roundtable.

Service user Josh Jarrett reported that pressure was brought to bear on members to sign a “consensus statement” regarding addiction to medicines. The roundtable meeting was not informed of the existence of the Steering group, or the decisions it had made.

Professor Ashton voiced her concerns on the role of the roundtable in the following letter to Anne Milton dated 24 April 2012, (Attachment 6)

“Dear Anne Milton,

                I have reluctantly come to the conclusion that the Round Table Meetings organised by the Department of Health are designed mainly to give the illusion of activity by the DoH.  In practice, their only effect is to camouflage the lack of political will concerning the action that needs to be taken in respect of long-term prescribed benzodiazepine users who have iatrogenically become dependent on benzodiazepines and need services to help them with drug withdrawal and other problems.  The result of these meetings has been that the DoH has done nothing effective to help this large population (estimated as 1.5 million in the UK).

I note that several attendees and others with similar concerns have voiced the same opinion.  For this reason I am suggesting that members of the Round Table who agree with the above conclusion should refuse to attend the next Round Table meeting (which is scheduled for several months ahead despite the need for urgent action)…”

“…You were not able to meet me personally but you suggested instead that I should talk to your Senior Policy Advisor, Mark Edgington.  I have had long and comprehensive telephone discussions with him, but it seems that my comments have not been accurately conveyed to you…” 

Service user and roundtable member Josh Jarrett also expressed concerns regarding the lack of benzodiazepine experts, the lack of discussion about involuntary tranquilliser addiction and the fact that he did not have a vote in his own right but had been “tagged” to Camden Mind (Attachment 7)

PART B.  Exemptions claimed by the Department of Health in its Internal Review response of 6 November 2012

The Department has relied on three exemptions:

(a) Section 22 has been applied in relation to certain unspecified information

(b) Section 35(1) has been applied to the withheld correspondence and minutes

(c) Section 40 has been applied in support of withholding the names of some members of the Steering Group.

Section 22 (The exemption for information intended for future publication)

Page 7 of the DH FOI Internal review letter: “As this demonstrates, the Department continues to seek to make a wide range of information available and therefore we now wish to engage the s. 22 exemption of the FOIA to exempt some of the information we are currently withholding under s. 35 (1) (a).”

This Section 22 exemption to an unspecified part of the minutes was not applied in response to my original request and seems to be an afterthought.

The consensus was launched by publication in the Times newspaper on 16 January 2013 and also made public on various websites including the Royal Colleges of GPs and Psychiatrists.

Therefore, the Section 22 exemption is no longer valid because the consensus has now been published and the unspecified information should be released.

Section 35 (The formulation or development of government policy)

Page 9 of the DH FOI Internal review letter states: “On 17 October, Ministers met the Vice Chair of APPGITA along with other colleagues.”

The Earl of Sandwich attended the meeting referred to in a private capacity; there was only one Minister, not Ministers as claimed and no APPGITA colleagues attended.

Page 6 of the DH FOI Internal review letter: “We have consistently engaged with the APPGITA and have only withheld information requested under the Freedom of Information Act when this has proved necessary.”

Page 9 “The evidence shows that successive Ministers have been open with the Chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Abuse (should read Addiction) meeting him and other parliamentarians, researchers and stakeholders connected with it on many occasions.

The DH have not consistently engaged or been open with the Chair of APPGITA, as confirmed in the following letter from Jim Dobbin MP (Chair APPGITA) to the Information Commissioner. (Attachment 9):

“The Information Commissioner’s Office                                       7 November 2012

Wycliffe House

Water Lane

Wilmslow

Cheshire SK9 5AF

Dear Sir,

I am chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction. Gillian Merron MP was Public Health Minister in July 2009 and announced a review of policy on addiction to prescribed medication. We had little contact with the Department in the early stages of the review; Anna Soubry MP became Public Health Minister in the recent reshuffle. Anne Milton MP was Public Health Minister for most of the time period covered by the review. I can confirm that with regard to interaction with APPGITA on this subject the Department have been secretive and difficult to deal with.

The meeting arranged by the Earl of Sandwich with Anna Soubry MP on 17 October

2012 was a private meeting with cross-bench peers, not an APPGITA meeting.

 Yours sincerely,

Jim Dobbin MP

Chair APPGITA

Jim Dobbin MP also expressed his concerns in this letter to Anne Milton dated 22 August 2012 (Attachment 10), where he states in the final paragraph:

“Finally, I have to tell you that the APPGITA is disappointed not to have been properly informed or consulted over the last two years as these substantial arrangements were prepared and more recently as they have been implemented. In my view it is not appropriate for an APPG to trawl around the internet in order to discover what policy the Department has introduced. I would therefore be interested to know what, in your view, is the role of an APPG in policy formulation.”

The effect of the secrecy in which the DH conducted the policy review is that the internet and FOIs became the main source of information on the policy review for the APPGITA.

The DH argument that there is “on-going policy development, that is, the monitoring, reviewing, and analysing of existing policy” is one that the Tribunal has rejected in the past. In one of the leading decisions on policy formulation it said “we do not regard a ‘seamless web’ approach to policy as a helpful guide to the question whether discussions on formulation are over.” (EA/2006/0006, Dept. for Education and Skills & IC & Evening Standard, paragraphs 40 & 75(v)).

Section 40 (Personal data)

Identities of members of Steering Group below SCS level

There are six other members of the Steering Group below senior civil service level whose names have been withheld under Section 40.

Serving on a Steering Group of this kind indicates that they are fulfilling a responsible role and contributing to the policy making process which justifies revealing their identification.

I submit the following three ICO decisions in support of this:

1. “The Commissioner notes that central government departments will often remove officials’ names on the basis of a blanket policy, that junior, in their view, means below Senior Civil Service (SCS). The Commissioner believes the correct approach is to focus on the specific nature of the role and the relationship to the information rather than a simple cut off at SCS. The Commissioner notes the recent comments of the Tribunal in Home Office v Information Commissioner EA/2011/0203: ‘each individual’s case must be determined on its own facts, taking into account the sorts of issues we have set out above. It would not be appropriate, in our view, to impose a blanket policy on the disclosure or withholding of individual’s [sic] names based solely on an individual’s grade” (Decision Notice  FS50429932, Ministry of Justice, 11 June 2012, para 30)

2. “The Tribunal does not accept that there is a blanket level at which all junior civil servants are shielded from disclosure of their personal data. This has to be decided on a case by case basis, through consideration of the role and responsibilities of the individual and the information itself.”  (Decision EA/2010/0060, Dun & Information Commissioner & National Audit Office, para 40)

3. “Having examined the TRR [Transitional Risk Register] and heard evidence in closed session about the four named individuals we find that the names of three of those individuals should be disclosed because their role in relation to the TRR is similar to other individuals whose names the DOH does not object to disclosing. The only difference is their Civil Service grade.” (Decision EA/2011/0286, Dept of Health & Information Commissioner & John Healey MP & Nicholas Cecil)

I look forward to your response.

 Yours sincerely,

 John Perrott

Dear Nicky,

Your e-mail reply sent May 12 is confusing. The scope says that the Board of Science met immediately after the BMA meeting on addiction to prescribed drugs in January. I now understand from you that all they decided upon on that occasion was that a scope should be produced for future consideration. I had understood that the Board of Science discussed the meeting and produced or delegated the scope and would have directed its general content themselves

Surely the composition of the Board is not a secret! Why could you not tell me who attended the Board meeting  immediately after the general meeting, and who will be asked to give the scope future consideration? Is it the same BMA Board of Science who produced the 2013 BMA book Drugs of Dependence? Apart from Prof Mansfield and Prof Hollins, none of those Board members were at the January morning meeting and the scientists on that Board are mainly involved with illicit drugs , which was not the subject of the meeting.

You say that the scope is not a draft, but it is clearly titled DRAFT & CONFIDENTIAL.

Whoever wrote this draft scope had clearly not heard or read my talk in which I carefully set out the help that was needed from the BMA and the reasons for it. The writer completely ignored all of the many issues that I had raised and which needed to be confronted.  He or she did not seem to have any understanding of the subject under discussion, but went over old history, which, like the NTA and NAC reports and the DoH Round Table meetings and consensus statement,  have already been critically reviewed, found wanting and discredited for reasons given in my talk.

There were many mistakes and omissions, such as no mention of lack of withdrawal services for iatrogenically dependent benzodiazepine users [wrongly referred to as misusers] ; this lack of services through the PCTs was stressed  particularly, with evidence, in my talk; no mention of APPGITA (All Party  Parliamentary Group for Involuntary Tranquilliser Addiction) and much else, too much to mention here.

I am not sure whether these shortcomings of the draft scope are deliberate or occurred through ignorance or lack of understanding, but I am ashamed that the BMA could lend its name to this draft scope. I am also concerned about the apparent secrecy of the proceedings, including a lack of provision of minutes, even to those who took part in the general meeting, and your inability to provide the names of the members of the Board of Science.

For these reasons, I am unable to comply with your request to provide full comments on the draft scope.

Yours,

Heather Ashton

The Parliamentary Under-Secretary of State for Health Anna Soubry MP announced a change of direction on addiction to medicines at a conference organised by the National Treatment Agency in London on the 28 February 2013. In her keynote speech, Anna Soubry recognised that patients can become addicted to medicines “through no fault of their own” and form an important group which require specialist support. She thanked Jim Dobbin MP and Eric Ollerenshaw MP of APPGITA for bringing this problem to her attention and also the patients she had spoken to on her visits to the Bristol and District Tranquilliser Project, Addiction Dependency Solutions, Oldham and Oldham Tranx.

Anna Soubry later told BBC Radio 4 the time had come to put addiction to prescription drugs on the agenda and correctly identified poor prescribing as a main cause of the problem:

“I think there have been some GPs who’ve simply not been following the guidelines from their own professional bodies. They have been overly-prescribing these drugs for year after year when they clearly should not be doing that.”

The Minister has, to some extent, recognised the problem of involuntary tranquilliser addiction. However, the Health and Social Care Act 2012 came into force one month later. This reorganisation of the National Health Service has devolved responsibility for any treatment for addiction to medicines away from the Department of Health onto local authorities.

Commissioning

At the moment, it is unclear where the impetus to create new services for involuntary tranquilliser addiction will come from. The new commissioning system is designed to respond to demand, yet there is little demand for treatment for involuntary addiction, although there is a great need. Involuntary Tranquilliser Addiction is often an  unknown addiction as patients may not realise they are addicted and believe instead their doctor is prescribing medicine. Doctor’s meanwhile also may not realise the patient is addicted or they may realise and decide not to tell the patient.

None of the agencies involved in the new commissioning system have been allocated responsibility for making sure new services are created: the Department of Health, Public Health England, the CCGs or the Health and Wellbeing Boards.

Clinical Guidance

The dominant ideology in drug treatment services in the UK has been harm reduction treatment for drug misusers. This approach has been applied by the Department of Health and the National Treatment Agency to illegal drug users with very few drug free outcomes. This approach has also been wrongly and unsuccessfully applied to involuntary tranquilliser addiction

APPGITA was formed to lobby for specialised services for involuntary tranquilliser addicts. The defining word in this name is “involuntary” which corresponds to the patient population identified by Professor Ashton in her manual as therapeutic dose dependent. Professor Ashton also described this population in her speech to the British Medical Association 22 January  2012:

“those who had been prescribed such drugs by their doctors for anxiety or pain, did not misuse other drugs, but had unknowingly become iatrogenically dependent because of long-term prescriptions”.

This population benefits enormously from the withdrawal programme described in the Ashton manual. The Ashton method has drug-free goals and success rates of over 85% have been achieved. The iatrogenic/involuntary population have much lower success rates when treated as or with drug misusers. There is already a well-established and active All Party Parliamentary Group on Drug Misuse for those who wish to campaign on issues related to tranquilliser misuse.

Any newly commissioned tranquiliser services will need consistent national clinical guidance in order to treat patients safely and successfully. However, the various national guidances from the MHRA, NICE, the BNF and the RCGP are inadequate and have a tendency to suggest dangerous rapid withdrawal. APPGITA is therefore campaigning for the adoption of the Ashton manual as national clinical guidance for the proposed new services.

Andy Burnham MP, the Shadow Secretary of State for Health has convened an evidence session on tranquillisers to be held at 3.00pm on 5 June 2013 in the Boothroyd Room, Portcullis House at the Houses of Parliament.

Michael Behan

Campaign Co-ordinator

All Party Parliamentary Group on Involuntary Tranquilliser Addiction

Read letter Page 1

Read letter Page 2

Anna Soubry MP
Minister for Public Health
Department of Health,
Richmond House,
79 Whitehall,
London, SW1A 2NS

21 March 2013

Dear Anna,

On 12 March 2013 the MHRA posted a benzodiazepine learning module on its website, this information was circulated to APPGITA by Steve Taylor of the NTA. I have to inform you that APPGITA consider the MHRA information to be dangerous to patients in that it recommends an 8 week general withdrawal time-frame for tranquilliser patients.

Generalisations about tranquilliser withdrawal are unhelpful because withdrawal varies from patient to patient. The 8 week recommendation from the MHRA is dangerous because this constitutes an over-rapid withdrawal for the majority of long-term users. It is particularly dangerous at the present time when new services are being introduced because new and inexperienced practitioners may believe this advice to be reliable and evidence based information.

As you may know from your visits to Bristol and District Tranquilliser Project, Oldham ADS and Oldham Tranx experienced tranquilliser withdrawal practitioners often design withdrawal schedules for clients for 12 months or more.

This is done for three reasons:

1. Patient safety. Rapid withdrawal can produce intense withdrawal symptoms including epileptic fits, psychosis and can be fatal.

2. Successful outcome. Rapid withdrawal can produce bizarre and intensely painful physical and psychological withdrawal symptoms which may be unbearable and cause the patient to relapse during withdrawal.

3. Protracted withdrawal. Rapid withdrawal increases the possibility of a post- withdrawal syndrome that can last for many years or can result in long-term or permanent damage.

The MHRA has no experience of supporting patients during withdrawal and is not qualified to issue withdrawal guidance.  

The Department and the NTA have made good progress on Involuntary Tranquilliser Addiction (ITA) in recent months. However, this work will be wasted if the MHRA information results in an increase of over-rapid withdrawals.

The 8 week withdrawal time frame is one of many mistakes in the MHRA withdrawal advice in their learning module, for example:

• Tranquilliser tapering should not be described in percentages (or fractions) as this produces confusion and ambiguity; reduction schedules in milligrams are required.
•  The conversion to diazepam equivalence should be done in steps over 2 weeks. The MHRA advice does not say this.
• The MHRA advice contains no information on post withdrawal or protracted withdrawal syndrome, which can last for many years, particularly after rapid withdrawal.
• It is not possible to provide adequate withdrawal advice in one page which this learning module attempts to do.

There are many other inaccuracies in the remainder of the MHRA document, for example:

1. Z drugs are not discussed in the module and the appendix on prescribing trends excludes the 6.2 million annual Z drug prescriptions. This continues the misconception that Z drugs are not problematic. Z drugs react with the same receptors in the nervous system and have all the same actions as benzodiazepines and effects including adverse effects, tolerance, dependence and withdrawal effects. The increase in Z drug prescribing more than accounts for the reduction in the prescribing of benzodiazepines.

2.  The section on drug interactions makes no mention of interaction with the widely prescribed fluoroquinolone antibiotics, which are benzodiazepine antagonists, and can therefore precipitate withdrawal in those taking benzodiazepines and serious complications for patients already in withdrawal.

The MHRA has always provided inadequate and inaccurate information on tranquillisers and this has been an important cause of the problem of ITA. The Department’s policy review badly needed to look at the role of the MHRA however on 18 August 2010 Chris Heffer announced to a meeting of the Addiction to Medicines (ATM) Steering Group that the policy review

“ …would not encroach on the role of the MHRA in licensing or pharmacovigilance or clinical judgements of DH pharmacy in prescribing”

This decision placed the MHRA outside of the policy review and the flawed advice is one result of that decision. Similarly the 18 August 2010 announcement excluded prescribing decisions from the policy review, yet poor prescribing is the single main cause of ITA.

Clare Gerada Chair of the RCGP defends her member’s non-compliance with prescribing guidelines and has been increasingly vociferous in promoting tranquilliser use.

APPGITA continues to recommend the adoption of the Ashton manual for guidance on tranquilliser withdrawal. I suggest that the MHRA advice should be removed and redrafted; Professor Ashton has offered to help with redrafting. Furthermore the role of the MHRA should be reviewed with regard to ATM, particularly with regard to the assumption that the MHRA is able to offer advice on withdrawal from prescribed drugs.

I thought it important to bring this issue to your attention at an early stage and I hope you will take appropriate action. I would like to reaffirm APPGITA’s support for the work you have done on addiction to medicines. My concern is that this work should not be undermined and I look forward to your reply.

Yours sincerely,

Jim Dobbin MP

Chair APPGITA

This letter has been endorsed by Professor Heather Ashton

cc    Professor Sir Gordon Duff  Chair MHRA

Eric Ollerenshaw MP

Rosanna O’Connor NTA

Steve Taylor NTA