Thursday, July 02, 2009

Reply to Ministerial Response to "Addiction to Medicines" Debate

1st July 2009

The Rt. Hon Phil Hope MP

Minister of State for Care Services

Dear Phil,

I am chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Addiction (ITA). In reply to your ministerial response in the Adjournment debate in Westminster Hall, Tuesday 16th June 2009, on “Addiction to Medicines”, I would like to make the following points.

  1. Involuntary Tranquilliser Addiction

In the debate both Brian Iddon M.P. and Greg Mullholland M.P. specifically referred to Involuntary Tranquilliser Addiction as a substantial part of the overall problem of addiction to medicines.

In your response you do not acknowledge the existence of the ITA group. Instead you refer to “constituents… with experience of misuse.” Involuntary Tranquilliser Addicts strongly object to being called drug misusers. “Misuse” suggests blame on the part of the patient. It categorises them with people who misuse illegal drugs, such as heroin and cocaine. This issue arose before in 2006/7 when the then Health Minister, Rosie Winterton M.P., used this word in correspondence with Barry Haslam of Oldham. Michael Meacher M.P. complained on behalf of Mr Haslam, with the outcome that Rosie Winterton M.P. wrote a letter of apology and agreed it was unhelpful to apply such terminology (Your ref. P.O.00000175712 17/3/07).

Involuntary Tranquilliser Addition refers to patients who have become addicted to tranquillisers through no fault of their own. They have been introduced to the drugs by their doctors without proper warnings and have been unable to make an informed choice. In your response you discuss the amount of money the government spends on drug misuse as if part of that money is spent on ITA. The reality is that none of the drug misuse treatment budget is spent on ITA. Tranquilliser addicts are excluded from treatment and none of your remarks on the effectiveness of treatment apply to ITA.

Brian Iddon informed the debate that 1.5 million people are addicted to benzodiazepine drugs, if ‘Z’ tranquillisers are included the total is around 2m.

  1. The MHRA

Your description of the role of the MHRA is incomplete. Historically the MHRA, and its predecessor organisations, have a large responsibility for the involuntary tranquilliser problem. The Committee on Safety of Medicines (CSM) issued Product Licences in the 60’s and 70’s for benzodiazepines with no assessment of safety or efficacy. Data sheets were issued with inadequate warnings on toxicity and addiction. Patient complaints were dismissed as anecdotal. UK benzodiazepine data sheets have been, and still are, 10-15 years behind those issued in the USA, Canada, Australia and Scandinavia.

Post-marketing surveillance by the MHRA regulators has been poor and relies on a discredited Yellow Card System. It is not a matter of strategies. The Chairman of the MHRA, Professor Sir Alastair Breckenbridge, told the Health Select Committee:

“One cannot say what the incidence of an adverse reaction is. You cannot tell that from Yellow Card reports.”

(Q802, Health Committee Enquiry, 2004/5 “The Influence of the Pharmaceutical Industry”)

“In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines with necessary prescribing constraints are licensed.” (HSC Report V.1. P5)

Regarding the regulatory powers of the MHRA which you mention, these have not been used in the case of tranquillisers, and the manufacturers Roche Products and John Wyeth.

  1. Internet Pharmacies

As far as involuntary tranquilliser addiction is concerned, internet pharmacies are a secondary issue. ITA is created within the Health Service. Later that addiction may be fed by the internet but the original addiction is created by Health Service doctors. Large scale tranquilliser addiction existed before the internet.

  1. Controlling Prescribing

You listed various mechanisms and publications used to “promote and support high quality clinically effective prescribing… to ensure patient safety.”

A similar list of mechanisms was read out in 1999 by the then Health Minister, John Hutton M.P., in a debate on “Benzodiazepines” also held in Westminster Hall. John Hutton assured “that we are acting to reduce high levels of prescribing.” (Hansard 7.12.99).

In the period 1998-2009 tranquilliser prescriptions have increased from some 13 million p.a. to 17 million p.a. (Answer by Dawn Primarolo to P.Q. 274692. 18/5/09). Clearly the mechanisms did not work for John Hutton and are unlikely to begin to work now.

The Department of Health abdicates responsibility for controlling the large scale mis-prescribing of tranquillisers:

“We expect individual prescribers to be aware of the potential for addiction and to ensure that medicines are prescribed appropriately, depending on a patients individual needs.”

(Phil Hope M.P., Westminster Hall, 16/6/09)

The Department of Health tries to nominate the General Medical Council (G.M.C.) to take on the responsibility of controlling prescribing. The GMC has never accepted that responsibility. The GMC may look at individual cases. In individual cases a doctor prescribing outside the guidelines is not considered negligent if other doctors are prescribing in the same way (the “Bolitho” defence). Mis-prescribing of tranquillisers is so common that the individual mis-prescriber becomes legitimised. This defence applies both before the GMC and is successfully used by doctors in civil litigation cases where patients have alleged negligent prescribing by their doctors.

The GMC does not look at the large-scale systemic mis-prescribing that underpins ITA. The GMC is not responsible for enforcing prescribing guidelines and does not claim to do so. The Department of Health has not asked the GMC to enforce prescribing guidelines. This is an imaginary responsibility that the Department of Health invokes when avoiding its own responsibility for controlling prescribing.

  1. Research

The two areas of research you mention are understanding addiction and treatment. As far as involuntary tranquilliser addiction, these two areas have been researched by Professor Heather Ashton of Newcastle University. Professor Ashton has developed a system of tapered withdrawal and produced a handbook “Protocol for the treatment of Benzodiazepine Withdrawal.” This has been used successfully worldwide, and has been developed by the U.K. tranquilliser withdrawal charities CITA (Council for Information on Tranquilliser and Anti-Depressants)and BAT (Battle Against Tranquillisers).

We do not know the mechanisms whereby patients are damaged physically and mentally by these drugs. Research is needed into the long-term and permanent damage caused by tranquilliser use.

  1. Treatment of Involuntary Tranquilliser Addiction

No treatment is provided by the National Health Service for Involuntary Tranquilliser Addiction. Patients who become addicted are excluded from treatment and left to fend for themselves.

The Department of Health policy is to make repeated declarations that treatment for ITA is the responsibility of the Primary Care Trusts. However the Department of Health provides the PCT’s with no budget and no targets for this service, thereby ensuring that there can be no treatment provided.

There is no reason why ITA should be the responsibility of PCT’s. For illicit drugs there is a National Treatment Agency, National Drug Strategy and National Budget. It should be the same for ITA.

Our recommendations for treatment are:

  1. A national network of local specialised tranquilliser withdrawal clinics

  2. NHS funded local support groups

  3. NHS funded 24 hour national tranquilliser helpline

  4. Regional residential clinics for severe addiction

  5. Training for specialised tranquilliser withdrawal counsellors.

  1. Statistics

On 18 May 2009, Health Minister Dawn Primarolo M.P. answered Parliamentary Question 274692 and gave the total 2008 tranquilliser prescriptions for the UK as:

Benzodiazepines 11,439,000

Z Drugs 5,665,000

Giving a total of 17,104,000 tranquilliser prescriptions for 2008. This is an increase of 2% on 2007. This is about the prescribing level of 1992.

The Department of Health have created a smokescreen of imaginary responsibilities for various groups regarding tranquilliser prescription controls and for tranquilliser withdrawal. None of these responsibilities exist in the real world. The various groups, the MHRA/GMC/PCT, do not accept these responsibilities and do not take any appropriate action. Phil Woolas MP said in 1999 in the first Westminster Hall debate;

“The story of benzodiazepines is of awesome proportions and has been described as a national scandal. The impact is so large that it is too big for Governments, regulatory authorities and the pharmaceutical industry to address head on, so the scandal has been swept under the carpet…

We need joined-up policy. We need recognition of harm done to thousands of people, robust guidelines that are forcefully promoted and a review of the classification of Benzodiazepines. We need stringent support for addicts in the NHS, social services and the voluntary sector, to ensure that the withdrawal from such drugs is beneficial and does not increase the pain and suffering of many addicts.”

(Hansard 7.12.1999).

Yours sincerely,

Jim Dobbin MP