Anne Milton MP
Minister for Public Health
Department of Health,
London, SW1A 2NS.
4th February 2011
Thank you for meeting with Jim Dobbin, myself and others on 8th December. I am grateful to you and your officials for taking the time to talk to us.
However, since we met I have had the chance to follow up a number of the points that were raised and answers that were given by officials. There seem to be quite a few matters which require further clarification and I would be hugely grateful if you would arrange for the following questions to be looked into. I have numbered each so that you can respond to each point in turn.
Issues arising from the meeting itself:
1. I questioned the destruction of the Ativan files by the MHRA.
Leigh Henderson for the MHRA assured me that all the information from the licence application was retained in the Summary of Product Characteristics.
I have since inspected the format of a SPC and I now realise that it comprises about ten pages, only contains prescribing information and does not provide evidence of safety. Licence applications may run to thousands of pages and could not be resolved on to the SPC.
Could you confirm this is the case?
2. Leigh Henderson further answered to Michael Behan that the lorazepam tablets SPC was available for viewing on the electronic Medicines Compendium but when I looked on this website there was no SPC for lorazepam tablets that I could see.
Could you please supply me with the web address where I can view the SPC for lorazepam?
3. Michael Behan also asked a question regarding the accountability of pharmaceutical companies; this related to my concerns about the destruction of the Ativan files. Leigh Henderson stated that companies have a legal responsibility to provide truthful information when making licence applications. When Michael Behan pointed out that this is not enforced by the MHRA, Leigh Henderson assured us that companies have been prosecuted in the past.
I have since become aware of an answer to a Parliamentary question on 25th March by Jim Dobbin MP provided by the then Health Minister, Dawn Primarolo MP, [Hansard 196407], stating that no pharmaceutical company has been prosecuted by the MHRA (or its predecessors) for withholding information since 1992, and I am further informed through other sources that in fact this type of prosecution has never taken place.
Could you confirm the veracity of the answer Jim Dobbin received and, if no prosecutions have ever been made, where this leaves the MHRS enforcement strategy.
Apparent discrepancies in information provided in answer to two of my Parliamentary questions:
4. In response to my Parliamentary Question of 3rd December 2010 [Hansard 27797] asking how many generic lorazepam licences have been issued, the answer provided was twenty six. In a subsequent answer to a similar question [Hansard 31749] the answer provided was twenty eight when two licences for Metwest Pharmaceuticals Ltd were added. It has since been brought to my attention that other licences were not provided including those for Genus Pharmaceuticals and Chelonia Healthcare Ltd.
Would you please look into the apparent contradictions in these answers and please now clarify how many generic lorazepam licences have been issued in total and to which companies and on which dates.
5. Would you also please clarify the term ‘Not Confirmed’, [Hansard 31749], given as the legislative basis for seventeen of these generic lorazepam licences and why the MHRA are unable to confirm these details?
6. In answer to my Parliamentary question [Hansard 21751] the Department stated that the legislative basis enabling these generic lorazepam licences was Directive 2001/83/EC Articles 10.1 and 10c. However, when I asked this same question again [Hansard 31750] the answer provided was a different one, Directive 65/65/Ec Article 4.8a.
Would the Minister please clarify which answer was correct and, if it was the latter, by which section of Directive 65/65/EC Article 4.8a these generic licences were enabled; section (i), (ii) or (iii), indicating which section was used for each licence?
Additional queries following the meeting:
7. The early benzodiazepines, Librium and Valium, were given Product Licences of Right in 1971 for which the manufacturers did not have to provide any evidence of safety.
Ativan was granted a licence by referring back to Valium as a similar product as regards safety. The generic lorazepam licences were granted by bridging back to the Ativan licence as regards safety. Therefore all these licences have been issued in a sequence which has no safety evidence at the beginning.
Can the MHRA provide original safety evidence to support all of these Ativan/lorazepam licences?
8. Evidence of the harmful effects of benzodiazepines was presented by Professor Malcolm Lader to the Medical Research Council Neurosciences Board in 1981. Professor Lader’s study showed that 7 out of 14 patients on benzodiazepines had brain damage.
Professor Lader and the Neurosciences board indicated that further studies were required and this assessment still applies today. No action was taken and the file was closed until 2014. The Department of Health, the MHRA and the MRC were again made aware of this research recently.
Why has no action been taken in the light of the evidence provided by Professor Lader, either when it was originally presented in 1981, or now?
9. In an answer to my Parliamentary Question [Hansard 31750], the MHRA stated that clinical trial data is only held for 5 years yet in answer to my previous question [Hansard 27797] the MHRA explained that a period of 10 years is required to better establish the safety of a drug.
If clinical trial data is only held for 5 years what is used during the following 5 years that are required to better establish a drug’s safety? Is this 5 year retention period going to be reviewed?
10. According to all FOI responses which have been released to my constituent, Mr John Perrott and his colleagues, the MHRA destroys files unless there is a legal, regulatory, or business need to keep them or that they have historical interest.
These FOI responses also disclosed that the MHRA does not have a document destruction record; therefore it is not possible to ascertain what is destroyed or when.
Given the fact that some companies have histories of non-compliance with regulatory authorities, would you agree that a review of the MHRA’s record keeping policy might prove productive and help to ensure future discrepancies can be resolved properly?
11. Finally, with regard to the review, I was disappointed to hear that publication has been delayed yet again; are you in any closer to being in a position to provide a definite publication date.
Thank you for your attention in this matter and I look forward to receiving a response to each of the above points soon.
Eric Ollerenshaw MP
Jim Dobbin MP Chair of the All Party Parliamentary Group for Involuntary Tranquilliser Addiction
Lord Sandwich Vice Chair