APPGITA

OMAND REVIEW OF THE ACMD

SUBMISSION BY

JIM DOBBIN MP

I am chair of the All Party Parliamentary Group on Involuntary Tranquilliser Addiction (APPGITA) which was set up to raise awareness of the problems associated with involuntary tranquilliser addiction. Tranquillisers are highly addictive and toxic prescribed drugs. The tranquilliser drug group consists of the older benzodiazepines such as Diazepam/ Valium and Lorazepam/ Ativan and the newer “Z” drugs such as Zopiclone. Tranquillisers are heavily over prescribed by the medical profession, with over 17 million prescriptions in 2008 and an estimated 1.5 million patients dependent at any one time. Those dependent may suffer side effects whilst on the drug, a severe withdrawal syndrome which can last from 6 months to two years. Withdrawn patients may realise that they have suffered long term or permanent damage. The Department of Health is currently conducting a review of its policy on addiction to prescribed tranquillisers as part of a review on policy on addiction to prescription drugs in general.

Tranquillisers have been successfully over promoted by their manufacturers. In reality they have limited medical use and rapidly lose their efficacy. Prescribing guidelines restrict their use to 2-4 weeks but patients are often left on them for decades. There are numerous harms associated with their prescribed use but tranquillisers also have a high potential for misuse and have increasingly become a drug of misuse.

On the 7 April 2003 the tranquilliser campaign group then known as “Beat the Benzos”, led by Phil Woolas MP, John Grogan MP and Jim Dobbin MP attended a meeting with the then Home Office Minister Bob Ainsworth MP. The outcome of the meeting was that the group was invited by the Minister to make a submission to the ACMD on the harms associated with tranquillisers, with the intention of stimulating the ACMD to investigate the problem. In response to a written Parliamentary Question by John Grogan MP Bob Ainsworth MP repeated this invitation. This was the correct procedure according to the Misuse of Drugs Act and prescription drug harm falls within the remit of the ACMD. Consequently we expected the ACMD to give serious and proper consideration to the submission.

On the advice of the ACMD Technical Committee chaired by Professor Nutt the ACMD concluded that the reclassifying and/or rescheduling of benzodiazepines would be likely to be ineffective. At the time we were concerned that the Technical Committee had not given the submission proper consideration. The ACMD minutes later confirmed that the submission and attached evidence had been dealt with by a brief discussion, the issues raised were not addressed and no evidence scientific or otherwise was produced to validate the decision of the Technical Committee. The ACMD full Committee and the Technical Committee did not discuss benzodiazepine related deaths, benzo-babies, benzodiazepine date rape, the social cost of benzodiazepine dependence or the proposition that benzodiazepines had become a fully fledged drug of abuse.

We subsequently discovered that Professor Nutt had a serious conflict of interest in that he had a financial arrangement with the benzodiazepine manufacturer John Wyeth and Brother Ltd. Professor Nutt was in receipt of an honorarium and a research grant from Wyeth. Furthermore Professor Nutt did not disclose that conflict of interest in his dealings with us. This gives rise to a strong suspicion of bias on the part of Professor Nutt. Wyeth are the inventors and manufacturers of Ativan a controversial and notoriously addictive benzodiazepine. Ativan has been the subject of litigation in various jurisdictions including Australia, Ireland and Scotland. There were over 4,000 cases in the U.K. claiming manufacturer negligence and drug injury, although they were struck out on procedural grounds. Ativan has been implicated in celebrity deaths most recently that of Michael Jackson.

It is the purpose of this submission to argue that conflicts of interest are unacceptable for members of regulatory bodies such as the ACMD. It is not my purpose here to revisit the merits of the original 2003 submission although I have included a copy of it with the attachments (A) However I do intend to ask the Home Secretary for permission to return the 2003 submission to the ACMD on the grounds that he can have no confidence in the previous decision and advice.

The conflict of interest I have outlined above is only a small part of Professor Nutt’s financial arrangements with the pharmaceutical industry. In my view this is most important issue and the underlying cause of the Nutt affair. I believe the debates over scientific independence and freedom of speech are red herrings which have diverted attention away from the real issue.

A brief search gives the following results. The Medical Research Council website register of members interests (attachment B) shows Professor Nutt has consultancies with Sanofi, Aventis and Lundbeck; speakers fees from Eli Lilly, Glaxo Smith Kline and Bristol Myers Squibb and share options with Pivotal. According to a disclosure in a recent article in the Journal of Psychopharmacology “Prescribing antidepressants post Cipriani et al.”(attachment C) Professor Nutt also has grants, speakers honoraria or fees from Pfizer, Solvay Pharmaceuticals, Cypress Bioscience , Forest Labs., Organon and Wyeth. My information from academics is that these will all be substantial amounts in the region of £10,000 - £20,000 each. I would like to suggest that it would be beneficial if your review could obtain exact figures for each of the above interests and. also figures for the other members of the ACMD who have or had financial links with the pharmaceutical industry, particularly those who resigned in support of Professor Nutt.

Professor Nutt has repeatedly claimed in the media that he is an independent scientist working for the ACMD for no pay. It is my contention that Professor Nutt is in reality a campaigner and lobbyist for the pharmaceutical industry and he is well paid by them for the work he does. Professor Nutt is involved in numerous campaigns across the spectrum of prescribed and illegal drugs. He is involved in the development of “safe” recreational drugs, cognitive enhancers for healthy people, vaccinations against drugs, mood altering drugs and psychedelic treatments (LSD) for mental illness. Evidence for this is contained firstly in the “Drugs Futures 2025” literature of the Foresight think tank I have included their “Executive Summary and Overview” booklet in the attachments(D). Professor Nutt is the “Project key science expert” for Foresight. Secondly Professor Nutt is a Scientific Advisor to the Beckley Foundation who campaign for the legalisation of cannabis ,LSD and magic mushrooms.(Attachment E).

Professor Nutt has made no secret of his intention to replace the existing system of drug regulation at the ACMD with a new system designed by himself. The new system would end the distinction between legal and illegal drugs and would be the vehicle for the drug legalisation and normalisation which Professor Nutt advocates. The strategy set out in the above literature is to replace existing illegal drugs with Pharmacological Alternatives (PA) which would be licensed and certified as safe by the new regulatory system. This would capture huge markets and huge profits for the pharmaceutical industry. In my opinion this is the objective behind Professor Nutt’s agitation and the real cause of the current controversy.

My main recommendation is that ACMD members should no longer be allowed to have financial links with the pharmaceutical industry. The recently introduced ACMD Register of Members’ Interests should be improved so that members be required to make complete declarations, non-specific entries such as “independent consultant” should not be acceptable. For clarity an appropriate Code of Ethics should be designed for the ACMD Register to inform members of when conflicts exist and how they should be avoided. This is in addition to the existing Code of Conduct. I have attached information on Conflicts of Interest and Codes of Ethics (4).

There is also a possibility that conflicts of interest for pharmaceutical regulators are illegal under European law. In a Parliamentary Debate on the MHRA in November 2004 the then Health Minister Melanie Johnson MP informed the House of Commons that “we will bring UK policy into line with the new EU legislation on these matters, which requires experts should have no financial or other interest in the pharmaceutical industry which could affect their impartiality.” I have included a copy of the Hansard for this as attachment (G). I intend to request more information on this legal point by tabling a Parliamentary Question. I have also attached (HI) a copy of Early Day Motion 787 which I tabled 11.02.2009 calling for the resignation of Professor Nutt and a copy (JK) of correspondence with the ACMD, the Home Office and Professor Nutt on this issue.

Jim Dobbin MP 09.11.2009.