Pregnant woman was killed by train after doctor “failed to warn her an anxiety drug could cause suicidal feelings” Daily Mail 26 February 2015

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email to Jane Ellison, Public Health minister and Duncan Selbie, CEO, PHE

Dear Jane Ellison and Duncan Selbie,

I am writing regarding the Parliamentary Question below in which Liz McInnes MP asks for the declaration of interests for members of the expert group responsible for updating the Drug misuse and dependence – UK guidelines on clinical management to be made available.

 

Prescription Drugs: Misuse                                                 27 January 2015

Liz McInnes To ask the Secretary of State for Health, if he will publish the declarations of interest submitted by members of the expert group with responsibility for updating the UK guidelines on clinical management of drugs misuse and dependence.

Jane Ellison: The expert group updating the United Kingdom guidelines for the clinical management of drug misuse and dependence consists of a broad spectrum of stakeholders, including practising clinicians, pharmacists, service users, carers, psychologists, commissioners and academics. Each is required to complete a declaration of interests and keep this updated.

Public Health England, which provides the secretariat for the group, has reviewed these declarations and on the basis of the information provided believes that no expert group members have a financial interest in the prescribing of specific medicines for the treatment of dependence.

Clinicians’ declarations will be published alongside the updated clinical guidelines by early 2016.

It is not reasonable for the public to have to wait for over a year to see if there is a legitimate objection to anyone’s inclusion on the expert group on grounds of conflict of interest when it can be addressed now. By the time the revised guidelines are published, it will be too late to do anything other than seek to have the entire findings overturned, which would be most unlikely.

Conflicts of interest are considered to be undesirable because they can give rise to bias and corruption in academic work, or the perception of bias and corruption in academic work.

Professor Strang, who is chair of the expert working group, has financial relationships with many pharmaceutical companies, including the following companies which manufacture drugs to treat dependence:

Martindale/Cardinal, the leading UK supplier of methadone and naloxone

Auralis which manufactures diamorphine

Reckitt Benckiser which manufactures Suboxone

The Department of Health has in the past ignored concerns raised about conflicts of interest. For example, the late Jim Dobbin MP wrote to Andrew Lansley MP, when Secretary of State for Health, raising concerns about Professor Strang’s non-declaration of interests with pharmaceutical companies manufacturing benzodiazepines, z drugs and codeine containing products when co-authoring the NAC report commissioned by the Department of Health to inform its policy review on addiction to medicines. These drugs were the subject of the report.

The NAC report was biased making no mention of protracted or post-benzodiazepine withdrawal syndromes; scant mention of benzodiazepine related ill-health; no inclusion of literature on tranquilliser related deaths; no mention of benzodiazepine teratogenicity or “benzo babies” causing birth abnormalities by exposure to benzodiazepines in utero; dismissed Professor Lader’s study in 1980 linking brain damage to long-term benzodiazepine use in one sentence and; “missed” 129 academic papers stating the risks associated with benzodiazepine use easily accessible on the www.benzo.org website.

Do the Department of Health and PHE acknowledge that at least one member of the expert working group has conflicts of interest and will declarations of interest for all members of the expert working group be made available now rather than at time of publication next year?

Yours sincerely,

John Perrott

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Parliamentary Questions asked by Liz McInnes MP

26 February 2015

Prescription Drugs:

Liz McInnes: To ask the Secretary of State for Health, how many private prescriptions for (a) benzodiazepines, (b) z drugs and (c) antidepressants were issued in 2013; and whether such private prescriptions are included in the analysis by the NHS of prescription costs.

George Freeman: Information is held by the NHS Business Services Authority (NHSBSA) on the numbers of original private prescriptions for controlled drugs that are listed in Schedules 2 or 3 to the Misuse of Drug Regulations 2001 (as amended) (“the 2001 Regulations”) and dispensed in the community in England by NHS community pharmacies. These pharmacies submit regular returns to the NHSBSA for monitoring purposes only with no cost information collected.

No benzodiazepine drugs are listed in Schedule 2 to the 2001 Regulations. The benzodiazepines, flunitrazepam, midazolam and temazepam are listed in Schedule 3 to the 2001 Regulations. In 2013, the NHSBSA recorded 3,021 private prescriptions for these drugs, as defined within the British National Formulary Section 4.1.1 Hypnotics, Section 4.8.2 Drugs used in status epilepticus and Section 15.1.4Sedative and analgesic peri-operative drugs. Other benzodiazepine drugs are listed in Schedule 4 to the 2001 Regulations. No “Z” drugs or antidepressants are listed in Schedules 2 or 3 to the 2001 Regulations.

27 January 2015

Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, if he will publish the declarations of interest submitted by members of the expert group with responsibility for updating the UK guidelines on clinical management of drugs misuse and dependence.

Jane Ellison: The expert group updating the United Kingdom guidelines for the clinical management of drug misuse and dependence consists of a broad spectrum of stakeholders, including practising clinicians, pharmacists, service users, carers, psychologists, commissioners and academics. Each is required to complete a declaration of interests and keep this updated.

Public Health England, which provides the secretariat for the group, has reviewed these declarations and on the basis of the information provided believes that no expert group members have a financial interest in the prescribing of specific medicines for the treatment of dependence.

Clinicians’ declarations will be published alongside the updated clinical guidelines by early 2016.


Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, what steps he plans to take to reduce addiction to prescribed benzodiazepines and z drugs.

Jane Ellison: Public Health England (PHE), NHS England and others are working together to deliver a wide-ranging programme of work to reduce addiction to medicines. This includes completed work such as publishing a guide to commissioning services to respond to addiction to medicines, factsheets for general practitioners (GPs) (Royal College of General Practitioners) and delivering face-to-face training for GPs and other healthcare workers. Looking ahead, PHE is supporting a number of pilots of improved local commissioning.

There is now better awareness of these issues among GPs and clearer prescribing guidelines.


Tranquillisers: Misuse

Liz McInnes: To ask the Secretary of State for Health, if his Department will make an assessment of the implications for its policies of the survey of treatment services provided by local authorities for involuntary tranquilliser addicts conducted by the All Party Parliamentary Group on Involuntary Tranquilliser Addiction.

Jane Ellison: The Department has taken into account the All Party Parliamentary Group on Involuntary Tranquilliser Addiction’s survey in its deliberations in this policy area.


Prescription Drugs: Misuse

Liz McInnes: To ask the Secretary of State for Health, what steps he plans to take to ensure that patients prescribed benzodiazepines and z drugs are provided with recent Medicines and Healthcare Regulatory Authority advice on those drugs’ addiction potential and the time taken to withdraw safely from taking such drugs.

George Freeman: The Medicines and Healthcare products Regulatory Agency (MHRA) has not recently issued any new advice on the addiction potential or the safe withdrawal from benzodiazepines or “z drugs”.

Benzodiazepines and “z drugs” (zaleplon, zolpidem and zopiclone) are recognised to be associated with an addiction potential particularly when taken for longer than the recommended 2-4 weeks. Over the years action has been taken by the MHRA, the Department of Health and professional bodies to provide extensive warnings about the risks of dependence limit prescribing and issue advice about gradual withdrawal.

The risk of dependence on a benzodiazepine (or zaleplon, zolpidem and zopiclone) can increase with higher doses and longer duration of use; therefore, the time it takes to completely stop the medicine varies and withdrawal programmes may sometimes need to be individually tailored.

Patients receive a patient information leaflet in their pack of benzodiazepine (or zaleplon, zolpidem and zopiclone). The leaflet includes information and advice about their medicine, which will support the vital discussions they have with their doctor and pharmacist about their treatment or stopping treatment.

Benzodiazepines and “z drugs” are considered acceptably safe and effective when used in accordance with the approved indications and for the recommended duration of use.

An online learning module for healthcare professionals on benzodiazepines was published on the MHRA’s website in March 2013. The module’s section on dependence and withdrawal gives general guidance on the principles of benzodiazepine withdrawal. The online learning module reflects the product information for these medicines.

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BBC News – Warning over drug-driving law and prescribed medication

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European Medicines Agency recommends suspending medicines including clonazepam

GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies

Products for which the marketing authorisations are recommended for suspension by the EMA on 22 January 2015

MHRA’s response to EMA’s recommendations to suspend medicines

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Up to 2 per cent of Germany’s population is dependent on hypnotics

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Over The Top: Tackling Medical Power

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APPGITA submission to the Labour Party Public Health manifesto

Andy Burnham MP, Shadow Health Minister, hosted two seminars at Westminster on the subject of addiction to medicines. As a result of these seminars a working group was formed, which included the late Jim Dobbin MP, chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction.The purpose of the working group was to provide Andy Burnham and Luciana Berger, Shadow Public Health Minister, with a manifesto submission on addiction to medicines.

Jim Dobbin presented this  submission from APPGITA produced by Mick Behan to Andy Burnham in May 2014.

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Correspondence with Duncan Selbie, CEO, Public Health England

Dear Mr Perrott                                                                                                   9 January 2015

I note you have also written to Rosanna O’Connor,  and she will respond in detail to your concerns, including on the proposed pilots.

I recognise that you are not happy with this approach. Notwithstanding, I hope you will provide comment on the pilots and help shape and guide them.

Best wishes, Duncan
Duncan Selbie
Chief Executive

Public Health England

0207 654 8095

Protecting and improving the nation’s health

Dear Duncan,                                                                                                      10 January 2015

Constructive comments have already been sent repeatedly and in abundance to PHE and the NTA over the years by Professor Ashton and the late Jim Dobbin MP (APPGITA Chair). All of these have been ignored by the NTA and PHE.

PHE has also ignored Anna Soubry’s direction laid out in her keynote address at the NTA seminar on addiction to medicines.

We already have a world recognised expert in benzodiazepines in Professor Ashton and successful withdrawal charities for prescribed tranquilliser withdrawal with 30 years experience and 85% success rate with drug free withdrawal outcomes, based on the Ashton manual, whose practice simply needs to be duplicated nationwide.

Local areas do not have this expertise and neither does PHE.

Rosanna O’Connor does not take any notice, does not understand the subject and continues to adopt a substance misuse approach to involuntary tranqilliser addiction..

I will not be party to endorsing PHE’s flawed policy on addiction to prescription tranquillisers.

When this issue flares up again, which it will, I will be the first to focus attention on PHE’s role in its failure to provide appropriate withdrawal services.

I suggest that you investigate this yourself instead of relying on officials who do not understand the subject and have their own agendas and that you also visit Bristol and District Tranquilliser Project, which provides advice and support to some of the 1.5 million patients addicted to these prescribed drugs through no fault of their own.

Regards,

John

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Correspondence with Rosanna O’Connor, Director Alcohol and Drugs, PHE on the PHE outline proposal intended to support a small number of pilot areas to improve their responses to addiction to medicines

Dear Rosanna,                                                                                                   4/1/2015

Thank you for your email in which you asked for my comments on the PHE outline proposal intended to support a small number of pilot areas to improve their responses to addiction to medicines.

I must say that campaigners are very disappointed in this draft. I had hoped that the correspondence and information provided to PHE and the NTA by APPGITA, Professor Ashton and through our recent meeting last year would result in an increase in PHE’s understanding of the issue of involuntary tranquilliser addiction, but having read the document which you sent this is obviously not the case.

The draft guide repeats the same mistakes made in previous documents, including the PHE Commissioning guide and also reports submitted by the NTA and the NAC to inform the Department of Health’s policy review on addiction to medicines. All of these conflated the populations of involuntary tranquilliser addicts (ITAs) and illicit drug users and mixed up tranquillisers (benzodiazepines and z drugs) with opiates and other drugs.

The draft is overly complicated adopting a “one size fits all” approach and continues to misrepresent ITAs as substance misusers. There is not one mention of “iatrogenic” or “involuntary” in the document.

The only result will be a decrease in understanding of the issue by those who read it.

All the above points have been made clear to the NTA (now PHE) by APPGITA and Professor Ashton many times and I am beginning to wonder if PHE’s continuing lack of understanding of the issue is deliberate.

ITA is a simple issue – doctors have prescribed addictive tranquillisers beyond the 2 -4 week CSM prescribing guidelines issued in 1988. Tranquillisers used long-term alter the patient’s brain chemistry. The problem patients face are severe physical and psychological withdrawal symptoms experienced on dose reduction because the brain has to re-adapt to pre-drug conditions whilst reducing dosage. In many cases these symptoms last for many years after cessation and patients describe them as coming in waves.

Tranquilliser withdrawal therefore requires specialist advice and support and the treatment requirements are very different to those associated with illicit use and opiate addiction. The support and advice required is the same nationally, hence the ludicrous situation created by the Health reforms of having 152 local authorities and 212 CCGs all evolving treatment responses separately.

More detailed comments on the draft document you sent me are as follows; quotations from the draft are in italics:

Background

“The 2010 drug strategy requires local areas to “consider dependence on all drugs, including prescription and over-the-counter medicines”

The Drug Strategy 2010 is a substance misuse document which has no relevance to ITA. I have made this clear many times to PHE and you.

“Medicines problems can be a bridge into, or occur alongside or as an alternative to, illicit drug use, especially in secure environments”

Illicit drug use in prisons has no relevance to ITA.

“Plan

Clinical advice – clinical team consultant psychiatrist”

ITA is not a mental disorder but a condition created by taking tranquillisers long-term resulting in altered brain chemistry. The main problem patients face is dealing with and understanding the withdrawal symptoms whilst the brain re-adapts. This process may take many years during which specialist support is required.

Psychiatrists diagnose mental disorders and then prescribe drugs often leading to polypharmacy. Psychiatrists’ over-prescribing, mis-prescribing and poor and dangerous withdrawal advice has contributed significantly to the cause and continuation of the problem.

Clinical advice may be found in the Ashton manual, the NHS Clinical Knowledge Summaries and the BNF. The “Orange Book” is on substance misuse and is inappropriate. Also, the Factsheets produced by SMMGP are predominantly on substance misuse with only lip service paid to ITA.

Benzodiazepine expert Professor Lader said on “Face the Facts” in 1999 “It is more difficult to withdraw people from benzodiazepines than it is from heroin. It just seems that the dependency is so ingrained and the withdrawal symptoms you get are so intolerable that people have a great deal of problem coming off. The other aspect is that with heroin, usually the withdrawal is over within a week or so. With benzodiazepines, a proportion of patients go on to long term withdrawal and they have very unpleasant symptoms for month after months. I get letters from people saying this can go on for two years or more. Some of the tranquilliser groups document people who still have symptoms ten years after stopping.”

“Plan                                               

Data – NDTMS and advice on accessing and analysing prescribing data”

The NDTMS does not collect information on ITA and I recall at our meeting that you said that there were no plans for NDTMS to collect data on ITA in the future either.

“It would also cover qualitative evaluation of the pilots.”

Qualitative evaluation should include the following:

1. Using an outreach approach working with GP surgeries to identify ITAs as it is a hidden problem

2. Providing patients with information about their predicament and offering specialist withdrawal advice and support without pressure or threats to cut off prescriptions.

3. Service providers’ withdrawal protocols should follow the slow taper method with the patient in control as per the Ashton manual, with drug free goals (recovery can never occur whilst still on tranquillisers).

“Funding will not be provided for service provision although limited funds will be made available for development activity, such as local events.”

Why will funding not be provided when the scale and nature of the problem dwarfs substance misuse for which funding and treatment is available?

Commissioners and service providers are still unaware of the scale of the problem, estimated at around 1 million. The NDTMS figure of 3906 quoted in the PHE Commissioning Guide has significantly contributed towards a continuation of this lack of understanding. Commissioners will be led by the Commissioning Guide to believe that the scale of the problem is small making allocation of funding extremely unlikely.

Interest

PHE centre alcohol and drug teams were asked in 2013 to suggest areas that might be interested or had expressed an interest in a pilot. Responses then included:

Southwark, London

Newcastle and N Tyneside, North East

CRi Dudley, West Midlands

Derby, East Midlands

Havering, London”

I am interested to know the reasons given by those expressing an interest in the issue. Are these areas aware of the benzo.org.uk website and the work of APPGITA? I see that one of them is Derby. Derby actually decommissioned ITA withdrawal services last year in a joint decision with ADS which provided them. The reason given was lack of uptake indicating that their approach was wrong in identifying ITAs because there will be several thousand in every local area.

Number of pilots and their selection

We probably only have the resources centrally to support a maximum of 4-5 areas.”

As I said at our meeting, this is inadequate. Coupled with the misinformation in the draft document intended to support these areas it is very likely to fail.

“Examples of different stakeholders’ contributions:

Primary care medical practices, commissioned by NHS England for general medical services, retain responsibility for initial responses to patients experiencing problems with prescription and over-the-counter medicines”

Primary Care medical practices have in fact been responsible for creating and sustaining addictions to tranquillisers for five decades. To refer patients back into this system will not provide a solution.

Doctors’ professional organisations continue to treat ITA as substance misuse to suit their own purposes, passing the blame on to the patients.

“Local authorities are responsible for commissioning services for drug and alcohol dependence, including ATM, which may work directly with severe and complex cases or provide specialist expertise and support to primary care”

Which specialist expertise? With very few exceptions the only expertise I am aware of is that provided by the withdrawal charities such as CITA and the Bristol and District Tranquilliser Project (BDTP). My survey proved that ITA is not being treated by local areas. Effective responses require drug and alcohol services to read, understand and implement the Ashton manual – many have not even heard of it – and to follow the successful withdrawal advice and support as practiced by CITA and BDTP.

I would recommend that you visit BDTP which would give you valuable insight which may then be passed on to the pilots.

“Medicines management, and especially controlled drug accountable officers (CDAOs), monitors and ensures the safety of prescribing”

This is incorrect. CDAO’s have no remit or jurisdiction over doctors’ prescribing which is deemed “clinical judgement”.

“Community pharmacies, which may be commissioned by NHS England, CCGs and local authorities, are an important frontline in identifying problems, especially with over-the-counter medicines, and providing a first line response”

I am informed by a local pharmacy manager that pharmacies do not take up issues such as the over-prescribing of tranquillisers because they do not wish to fall out with the doctors or challenge their clinical judgement.

There is no record of any pharmacy taking up this issue with GP surgeries.

“Some areas have a long history of providing effective, integrated responses. Some of these have been featured in PHE-collated practice examples from which others can learn.”

Please send me details about these examples.

“High levels of prescribing and need for attention to ATM in the area (North East, North West and Y&H feature heavily in the prescribing data and some parts have already done some work on the issue. South West has supported dedicated and integrated services and been keen to develop further)”

Please send me details about the work already done by these areas.

In summary, if these pilots are to succeed and pass on their understanding to other areas it is crucial that the support and advice given to them increases their understanding of the issue. The draft you have sent me will have the opposite effect.

I hope that you will take my comments on board and I will be happy to provide advice on any amended proposals.

Best wishes,

John

 

John                                                                                       23/12/2014

As promised when we met, we have progressed our plan to support a small number of pilot areas to improve their responses to addiction to medicines. We have to leave it to the areas themselves to decide where and how they focus their efforts, according to local need, but we have provided our PHE Centre teams with the attached outline proposal and they have started to identify a small number of areas interested in taking part.

I would really welcome any comments or suggestions you may have on the attached outline, or on how the pilots might be improved, as I fully appreciate your interest. We will be aiming to confirm the local pilot areas and to support them in working up their plans in the New Year so comments by the time we all return to work in earnest in the week beginning 5 January would be great.

In the meantime, I hope you and Steph have a good Christmas time and a Happy New Year.

Best wishes,

Rosanna

Rosanna O’Connor

0203 682 0501

07776 250 724

 

Dear Rosanna,                                                                                             4/1/2015

As you will have gathered by my email I did not realise that you have already sent the outline proposal to the PHE Centre teams but having read your email again I realise that the document has already been sent. I fail to see how anyone would understand about involuntary tranquilliser addiction by reading your outline proposal which does not explain that this is about people who have been damaged by taking drugs prescribed by their doctors only and by the nature of the pharmamcology of the drugs require specialist support and help, many of them for years.

Professor Lader was correct in saying these people will “go to their graves with their pill bottles beside them”.

Why did you not consult APPGITA before sending it out?

Yet again, decisions are made behind closed doors and patients will continue to be damaged and misrepresented as substance misusers.

Regards,

John

 

Dear Duncan Selbie,                                                                         4/1/2015

Having had what I thought was a productive meeting with Rosanna O’Connor and Alex Sienkiewicz last September on the issue of involuntary tranquilliser addiction I am more than disappointed to receive the PHE outline proposal intended to support a small number of pilot areas to improve their responses to addiction to medicines, which is a pointless, confused document which will be no help whatsoever to those addicted through no fault of their own to tranquillisers prescribed by their doctors.

You may read correspondence between myself and Rosanna on the All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) website link below.

When you have read this correspondence would you please provide me with an explanation as to why PHE have got this so wrong?

Correspondence with Rosanna O’Connor, Director Alcohol and Drugs, PHE, on the PHE outline proposal intended to support a small number of pilot areas to improve their responses to addiction to medicines

Regards,

John Perrott

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