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LETTER FROM BARRY HASLAM TO CHRIS DAVIES MEP
April 10, 2009
From: Barry Haslam, Benzo Campaigner, Oldham
TO: Chris Davies MEP, 87a Castle Street, Stockport, SK3 9AR
April 10, 2009
Re: Involuntary Benzodiazepine Drug Addiction; 50 Years of NHS Scandal and Cover-Up
Thank you for Danny's letter and enclosures dated April 6, 2009.
Mr Verheugen's answer on behalf of the Commission E-0625/09EN (March 24, 2009) is weak and naive on iatrogenic drug addiction and the consequences. The NHS, according to Mr Verheugen, is a "national competent authority of a member state."
After 50 years prescribing of benzodiazepine drugs we still have no national policy for withdrawal treatment, no residential care centres (only psychiatric units), no after care, no national help line, no integrated and funded support groups and no national recognition.
The NHS is not a "competent authority". Exactly the reverse is true - certainly on benzo issues. The NHS has "swept the problem under the carpet" (Phil Woolas MP, 1999).
The benefit/risk balance of benzodiazepine drugs never took place within the UK. These drugs were given a licence of right by the UK regulatory authorities to the pharmaceutical companies at that time eg Hoffman-La Roche and John Wyeth & Brothers.
Licences were granted despite very poorly conducted trials. Agreement was pushed through with horrendous consequences to UK patients and their families. Patients quickly became addicted to their products at a great human and social cost.
The 1988 Committee on Safety of Medicines (CSM) Guidelines on 2-4 weeks use of benzodiazepines only is routinely ignored by the medical profession. The Guidelines should be mandatory for all patients. The "doctor knows best" attitude to benzos has however left a legacy of thousands of killed and disabled. Lives have been lost and destroyed.
There are currently one and a half million long-term addicts on prescribed benzodiazepines and many more millions of EU addicts – addicted for 20, 30 o4 40 years.
Mr Verheugen writes, "Medical professionals are aware that benzodiazepines are addictive if taken for more than a limited period and may have effects on the mental health of patients at the time of withdrawal." His comments are at odds with my point in (3) above. Not only are they incorrect, they are insulting to victims. Medical professionals need to be educated and informed about benzodiazepine drugs by ex-addicts who are the true professionals who have learnt by experience and not by books!
I am not in the least surprised to learn that "benzodiazepines are the class of drugs the most frequently subject of forged prescriptions."
Chris, five years ago we met the European Commissioner for Health – Mr David Byrne - in Brussels. We presented him with a report which was not acted on.
Both the legal and illegal benzodiazepine (and related) drugs situation is worsening here and across the EU. We are still getting the same empty words and platitudes and no action from the European Commissioner.
What are you prepared to do about this situation? What can be done?
It really is a disgrace.
Malcolm Chisolm SMP
Jim Dobbin MP
Phil Woolas MP
Ann Milton MP
Aland Johnson MP
Janice Barker, Oldham Chronicle
From: Chris Davies MEP, 87a Castle Street, Stockport, SK3 9AR
April, 6 2009
Many thanks for your recent letters, the contents of which I'll give full attention as soon as I am able.
Please find enclosed a copy of the response to Chris's parliamentary question which was received in our Brussels office a week ago.
You will see within reference to the Commission requesting advice from the European Medicines Agency viz the possibility of assessing and harmonising warnings over the risks of dependency related to benzodiazepines.
Chris has suggested that he follow this up after the elections in June with the EMA.
Office of Chris Davies MEP
9 February 2009
WRITTEN QUESTION by Chris Davies (ALDE) to the Commission
Subject: Over-prescription of benzodiazepines
The Commission will be aware that the over-prescription of benzodiazepines has led to hundreds of thousands of patients across Europe becoming addicted to these drugs, in many cases with severe consequences for their mental health.
Appearing before the Committee on the Environment, Public Health and Food Safety on 1 April 2008 Commissioner Vassiliou referred to the need for proper information to be supplied to patients about toe nature of these drugs, not least through labelling of containers She also stated that she would be very involved in this matter' despite it falling within the remit of another directorate.
Will the Commission state what progress has since been made in this matter?
Is the Commission aware of the existence in any Member State of any residential facility for the victims of involuntary benzodiazepine drug addiction, and if so, would this be available under appropriate conditions for UK citizens?
E-0625/O9EN - Answer given by Mr Verheugen on behalf of the Commission, (24.3.2009)
Benzodiazepines currently available in the Community have been authorised by the Member States and therefore their monitoring and surveillance (including the risks in relation to dependence/addiction) are primarily under the responsibility of the national competent authorities of the Member States.
In order to obtain a marketing authorisation for such medicinal products, an application shall be made to the competent authority of the Member State, accompanied by required documents, stated in Article 8 of Directive 200 1/83/EC1. The competent authorities, before granting the marketing authorisation, need to assess the benefit-risk balance of the product concerned, and will grant the marketing authorisation only if it is positive (Article 1(28a) and Article 26 of Directive 2001/83/EC) In this regard, the risk of dependence/addiction of a given medicinal product should be considered in the framework of this benefit-risk assessment. Besides these provisions, it should be noted that in the scientific guidelines of the European Medicines Agency, the evaluation of the potential for causing dependence is systematically required for medicines to be used in the treatment of psychiatric disorders for which benzodiazepines are still considered as a treatment option.
Benzodiazepines have been available for a long time and the main risks associated with their use, such as the risk of dependence, are well known and reflected in several publications and guidance documents. Measures to address such risks and to ensure the safe use of these medicines are also widely known: for example, benzodiazepines are only recommended for short term treatment (8-12 weeks and possibly less).
Relevant safety information/warnings on the risks of benzodiazepines are in general reflected in the product information for such medicines (summary of the product characteristics and package leaflet) Concerning the appropriate maximum dose to be used it needs to be taken into account that the class of benzodiazepines includes a number of different active substances and therefore this could only be addressed on an individual basis and reflected in the product information. Finally account should also be taken that the posology and duration of treatment are also subject to evaluation of the condition and of the patient being treated by the prescribing physician.
In this respect, the Commission emphasizes the important role of healthcare professionals on giving the relevant information to patients about the medicines they use. Medical professionals are aware (through the summary of the products characteristics) that benzodiazepines are addictive if taken for more than a limited period and may have effects on the mental health of patients at the time of withdrawal.
In addition, a project co-funded under the framework of the public health programme 2003-2008 called OSIAP was aiming at assessing the abuse of pharmaceutical products legally on the market as a public health issue in relation to prescription practices and control. Six countries were participating in this project. The first results showed that narcotics prescriptions are the most falsified. The final results, which are supposed to be published soon, show that benzodiazepines are the class of drugs the most frequently subject of forged prescriptions (modification of a true prescription), with differences between countries.
In any case, the Commission will request the advice of the European Medicines Agency on whether Community action is necessary in order to assess and harmonise to the extent possible the warnings concerning the risks of dependency contained in the marketing authorisations for benzodiazepines.
The Commission is aware of the special needs in the treatment of people, who've developed an addiction to benzodiazepines. In particular, this concerns detoxification treatment, which has to be done under close medical supervision. However, the expertise to implement detoxification should be available in most emergency units and hospitals throughout the EU. As far as residential treatment, including that of benzodiazepine addiction, in therapeutic communities is concerned, information on services available in the United Kingdom is available, for example, through the Internet.
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