Mr J Perrott
20 Greenacre Court
Lancaster
LA1 4LE
Date: 8th March 2011
Dear Mr Perrott
Subject: Formal Complaint (our ref: CC0067)
Reference: Formal Complaint regarding Dr June Raine and responses to questions and issues concerning Ativan and generic lorazepam licences.
I wrote to you on 4th February concerning your initial complaint concerning Dr Raine. You responded on 17th February saying you remained dissatisfied and that wished your complaint to be referred to the Independent Complaints Adviser (ICA). I emailed you on 22nd February suggesting that a meeting with Dr Raine and relevant staff here might help to resolve some of your questions and give an opportunity for any further clarifications to be made. Initially you accepted this invitation but on 23rd February advised me that you had changed your mind on the matter and wished for your complaint to be referred to the ICA as it stood.
The complaints process, including reference to the ICA, can only deal “administrative” issues. That is, issues concerning levels of service from staff at MHRA, how staff have behaved towards you, delays in responding to correspondence, etc.. The process does not cover issues pertaining to provision of information and data requested. This must be dealt with under the Freedom of Information Act (FOIA) which has provisions for reviewing decisions made by the organisation if the requestor is dissatisfied with the response to a particular request for information and, ultimately, for the requestor to refer to the Information Commissioner’s Office (ICO) at the end of that process if necessary.
In your initial complaint, I dealt with the administrative issues that you raised. Essentially these were:
1. Dr Raine provided you with inaccurate information concerning the MHRA’s record management and although referred to searches done for specific files, no such documentation has been disclosed and questions concerning what was found remain unanswered.
2. In relation to the licensing of generic lorazepam licences the MHRA have stated on different occasions two different directives: Directive 65/65/EC (article 4.8a) and Directive 2001/83/EC used in the approval of licences.
3. Dr Raine concealed the fact that the MHRA routinely destroys important safety material and this brings into question any generic drug’s safety by referring back to safety information impossible.
These were the issues I addressed in my letter of 4th February.
The detail of your letter to me of 17th February raises a number of new issues, some of which would fall to be dealt with under the FOIA, and which do not appear to be a straightforward disagreement with the response to the issues I dealt with in your first letter. I am therefore dealing with the letter of 17th February as a new complaint.
The main issues on which you wish to complain are below along with responses:
1. The subject matter of all my enquiries and questions since writing to Dr Raine in February 2010 has related to the safety of Ativan and subsequently other benzodiazepines.
It would therefore be clear from the first instance that I required information related to the safety of Ativan. This would obviously include information accompanying the licence application, including clinical trial data; subsequent expert evidence, advice and consultations and; the considerations of Committees including the CRM and CSM.
It is my view that I am being drip fed information and I wish to request unrestricted access to this Ativan Gold File and I would also like to know why I was not informed of its existence and contents in the first instance.
I therefore dispute your conclusion that Dr Raine did not conceal information; at best she has been economical with disclosure of information.
I have met with Dr Raine and her team in the last couple of days to discuss the detail of the points raised in your new letter. As I understand it, your initial correspondence with the Agency raised questions that were very specific and related to the original licence documents and generic applications. The gold file does not contain the original licence documents requested and hence this was not referred to by name in the earlier responses to your letters. It had, however, been included in searches for the information you had requested. The name “Gold File” relates simply to the colour of the file cover we used when we worked on paper records. It was not considered that making reference to a “Gold File” would make any sense to anyone outside the MHRA, hence it was not referred to by name until specifically requested by you in the email of 14 January. Following your FOI request (FOI 11/062) you are now aware of the size and time period covered by the Ativan Gold File.
Your initial correspondence with the Agency was of the nature of asking for information rather than asking for sight of documents. It is only since around December that you have been asking for sight of specific documents. In answering your initial letters, Dr Raine has endeavoured to answer the specific questions you have raised –on one or two occasions, copies of documents have been provided as part of those answers. If you now wish to have sight of further documents, which your letter of 17th February indicates, you must make that application through the FOI procedures and you may do this through e-mailing our information centre in the first instance (info@mhra.gsi.gov.uk). You may wish to consider making your requests for information specific as blanket requests, for example, “everything you have on…”, are likely to be turned down, at least initially, on grounds of cost under the FOI Act. Being as specific as possible will help us to identify information -where held- and prevent unnecessary delays caused by having to ask you to refine or clarify your request
You contend that you have deliberately been drip fed information and that Dr Raine has been economical with disclosing information. Dr Raine and her team have endeavoured to answer the specific questions you have raised a fully as possible on each occasion. Unfortunately the nature of this sort of correspondence is that an answer to one question often ends up raising another and it is impossible to anticipate what that next question might be. This is one of the reasons why I suggested that a meeting might help resolve these issues and might avoid protracted correspondence.
2. You state that the agency was not directly involved in the 1986-96 litigation and that no related documentation has been found. This is not true and in fact the CSM, the regulatory authority at the time and predecessor of the MHRA, was a co-defendant in the litigation along with Wyeth and Roche. Dr Raine has already conceded in her letter of 15th July 2010 that the documents within the licence application could have been considered important and may have been used in this litigation.
I apologise for the incorrect statement regarding the benzodiazepine litigation – I have been advised that the regulatory authority was listed as a co-defendant. However, that does not change the fact that no files relating to the litigation have been found.
3. I accept that Dr Raine accidentally provided me with the wrong directive with regard to abridged applications. However, would you please explain in your capacity as Complaints Officer responsible for an independent investigation how you are able to apologise for this error on Dr Raine’s behalf?
Please see response to 4. below.
4. I have since noticed that Dr Raine has provided me with further mis-information regarding her answer by email of 2nd September 2010 where she stated that: ‘The original guidance to use benzodiazepines for no longer than 2-4 weeks was issued by the Committee on the Review of Medicines (CRM) in 1980.’. It was not until the CSM guidelines published in 1988 that this maximum period was advised. In fact, it was the inadequacy of warnings at the time that caused addiction and this is a further instance of inaccurate information provided which I would not expect from someone in Dr Raine’s position.
On this matter you have again correctly identified an error in the response and this was an unfortunate oversight. The CRM in 1980 advised that benzodiazepines should be used “short term” but the recommendation of 2-4 weeks was first made in January 1988 following the CSM assessment of dependence and withdrawal reactions. This was a factual error, and Dr Raine wishes to apologise for this oversight. In the meantime, in my capacity as independent reviewer of complaints, I do think it appropriate that I pass on to complainants the fact that a member of staff has expressed a wish to apologise for an error. However, should you require a direct apology on both this and the item at 3. above I will ensure that you receive it.
In response to your paragraph 5, my role as complaints officer is limited to the sorts of issues I have already dealt with. I cannot comment on specific licensing aspects nor give any opinion on the issues you raise here.
Conclusion
I do not uphold your point at paragraph 1. above for the reasons given. I am unable to include any issues relating to information you have or have not received through the complaints process. I recommend that you pursue any further requests for specific information through the FOI route. This gives you a formal route to request specific information and copies of documentation and deal with any dissatisfaction through set procedures.
I uphold your point at paragraph 2 and apologise for giving you an incorrect statement regarding the involvement of the regulator in the benzodiazepine litigation.
I also uphold your point at paragraph 4 in your letter of 17th February and Dr Raine is mindful of having made errors in giving answers on the two issues you have raised in the 17th February and 11th January letters. These are obvious errors and there was no intention to deliberately mislead. Any future correspondence will be thoroughly checked before being sent.
I cannot comment on paragraph 5 as it is outwith my role as Central Complaints Officer. However, I understand that Dr Raine has explained in earlier correspondence the methods of ongoing safety monitoring for products that does not rely on very old data. If you require further information regarding these processes, you may wish to make a specific request under FOI.
As I have said earlier in this letter, the nature of your questions and correspondence has changed since you first began corresponding with Dr Raine last year. You are now requesting sight of documents specifically and these requests have to be dealt with through the FOIA. In addition, whilst Dr Raine and her team have tried throughout to answer the specific questions you have raised as fully as possible, each answer they have given tends to raise another question for you which they cannot anticipate. With each additional piece of information you get, you understandably want to know more. It is for this reason I suggested that it would be beneficial for you and for Dr Raine and her staff to sit and discuss the issue with a view to resolving as many of the additional questions in one go.
I have considered and responded to the specific issues you have raised in your letter of 17th February that come under the procedures of the administrative complaints system. I have also directed you to the FOI procedures for future requests for information and indicated where I do not have a remit and so am unable to comment. Should you remain dissatisfied with the specific issues I have been able to deal with under the complaints procedure in either this or my earlier letter, you should write to me again and ask for a review to be carried out by either our Chief Executive or the Independent Complaints Adviser. New complaints will be handled accordingly.
Yours sincerely
Sue Jones (by e-mail)
Sue Jones
Central Complaints Manager
Head of Corporate Policy Unit
MHRA