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THE BENZODIAZEPINES

JOHN WYETH AND ATIVAN

SUBMISSION TO HEALTH SELECT COMMITTEE
ENQUIRY INTO THE INFLUENCE OF THE
PHARMACEUTICAL INDUSTRY
2004

Michael Behan
August 30, 2004

INTRODUCTION

Ativan is a highly addictive and dangerous benzodiazepine drug. The more inaccurate and defective are the warnings issued with such a drug then the more dangerous that drug becomes.

The purpose of this submission is to draw the attention of the Health Select Committee to the benzodiazepine scandal and to its architects the pharmaceutical manufacturers John Wyeth and Hoffman La-Roche (Roche Products). These manufacturers introduced a successful mass benzo addiction trap into this country. The trap was based on the provision of inadequate and defective drug safety warnings to the public and prescribers.

Those defective warnings remained in place until 1988 by which time a benzodiazepine addict population had been created.

The benzodiazepine addiction problem and the commercial success of the drugs has continued ever since. A stream of unwary patients is initiated into drug addiction by trusted doctors. Meanwhile, the Government has tinkered in the face of an enormous problem, and is misled by a flawed system of advisers, experts and regulators.

My perception is that of a sufferer of a benzodiazepine drug injury. My experience and the theme of this submission is that the pharmaceutical manufacturers have introduced and openly operated a psychotropic drug scandal with impunity.

They are confident that their influence is so strong that they possess a complete defensive shield - in the legal system, in the regulatory system and the Government Departments and can never be held accountable for their actions.

Application of the Terms of Reference

The first section of the submission, parts 1 and 2, address 'the provision of drug information and promotion'.

The second section, parts 3 and 4, address 'regulatory review of drug safety and efficacy'.

I am willing to give oral evidence.

My name is Michael Behan and I took the benzodiazepine Ativan from 1981-87 on prescription from my GP in the belief that it was a medicine.

Upon discovering that Ativan was a drug, I withdrew to a zero dose over six months. I suffered side-effects whilst ingesting Ativan and severe withdrawal symptoms during the tapering period. Many of these symptoms have persisted ever since, particularly neurological and musculo-skeletal symptoms, and I now believe that they represent permanent damage.

I was a litigant in the benzodiazepine litigation against the benzodiazepine manufacturers John Wyeth (Ativan) and Roche Products (Valium, Librium, Mogadon). I became a litigant-in-person in the High Court and the Court of Appeal. I subsequently petitioned the House of Lords and the ECHR. In connection with this I privately researched all aspects of the benzodiazepine for three years in The British Library, the Royal Pharmaceutical Library and the WHO and UN Libraries. I contributed to the Panorama special 'The Tranquilliser Trap'. I am assisting solicitors in Ireland in their Ativan litigation and acted as a researcher for the continuing Scottish Mogadon case against Roche Products. I was a founder and a Director of the charity "Beat the Benzos".

In these phases, as involuntary benzodiazepine addict, litigant, researcher and campaigner, I have encountered the pharmaceutical industry in several different ways. I have divided these experiences into four parts and draw my own conclusions.

  1. LITIGATION: The domination of the legal process by the pharmaceutical companies.

  2. RESEARCH: The drug companies own documents show the UK benzodiazepine scandal to be the intended outcome of the manufacturers - mass addiction.

  3. REGULATION: The processing and issuing of the Benzodiazepine Drug Licence by the CSM/MCA is suspect.

  4. GOVERNMENT: Control of psychotropic drugs has been infiltrated by regulators, advisers and self-styled experts who promote the agenda, the ideas and the products of drug manufacture to the detriment of public health.

SECTION ONE: THE PROVISION OF DRUG INFORMATION AND PROMOTION

Benzodiazepines: The Problem

Benzodiazepines are highly addictive. Ativan is one of the most addictive drugs known to man, a three year withdrawal (tapering of dose to zero) from the prescribed dose may be necessary, 12 months withdrawal is common. Benzodiazepine addiction is a physical addiction. The nervous system becomes reliant on the benzodiazepine chemicals, which replace natural chemicals in the nervous system. If the benzo chemicals are removed or reduced the nervous system cannot operate properly. The natural chemicals may regenerate slowly or not at all. Furthermore, benzodiazepines are poisonous. They insidiously poison the body and its organs.

While the dangers of benzodiazepines are enormous, their efficacy is limited. They do not cure anything. Benzodiazepines can only suppress the symptoms of anxiety and only for a short period. The Data Sheet recommendation is for a prescribing period of 2-4 weeks in total.

As the efficacy of benzodiazepines decrease, addiction can already be setting in. Also, paradoxical reactions can start to appear, the drug produces the conditions it attempts to treat such as anxiety, insomnia and anger. These are the first stages of the Tranquilliser Trap.

The current number of benzo addicts in the UK is estimated at one and a half million although no official figures exist. Many more people are ingesting benzos and are on their way to addiction. Many other ex-addicts have withdrawn but remain damaged. There is no treatment for benzo damage. Post-benzo sufferers are often left to struggle alone, stigmatised and excluded by the Health Service that made them ill.

  1. Benzo Litigation

    Benzo victims are often told by Government letter writers at the Home Office, Department of Health, MHRA, etc to seek compensation through the courts for any injury they have suffered. In fact, this is an impossibility. The pharmaceutical companies dominate the courts and the legal process with their power and money.

    I was a litigant in the benzo litigation against the manufacturers John Wyeth and Brother and Roche Products. The litigation ran from 1986 to 1996 with a peak of 17,000 complaints. The plaintiffs alleged that the manufacturers were negligent in failing to give adequate warnings of the dangers associated with their products. The manufacturers delayed and complicated the proceedings to the point that the Legal Aid Board could no longer meet the expense of the litigation. Each side spent more than £35m yet not one minute of court time was spent on the merits of the case; the time and the money was spent on technical motions and procedural wranglings. Under pressure from the defendants the LAB withdrew funding from the litigation.

    The defendants then successfully applied to the court for a strike out on the basis that the Plaintiffs would be unable to continue without funding and legal representation. The Legal Aid Board was disbanded in the wake of the benzo litigation and re-constituted as the Legal Services Commission with a new set of regulations designed to exclude the possibility of any similar litigation occurring again.

    The failure of the benzo litigation gave the pharmaceutical companies the green light. They had demonstrated they could not be brought to trial and that the evidence against them would not see the light of day. In reality, the consumer has no protection in law against pharmaceutical companies or rogue drugs.

    Powerful commercial corporations should not be immune to liability. Such potential liability acts as an incitement to developers of new products to ensure that their product is safe and this is a valuable counterbalance to the temptation to make fast profits.

    Recommendation

    My recommendation here is a no fault drug compensation scheme for sufferers of drug injuries.

    Secondly, the Government should set up an independent prosecuting authority to take on the pharmaceutical companies when necessary. It is unrealistic to expect a firm of solicitors to be able to take on the might of a multi-national. When convicted the pharmaceutical companies should pay proportionate fines in order to provide a deterrent.

  2. Documents

    The benzodiazepine manufacturers have pretended that the litigation collapsed because the drugs were safe and the case was weak.

    In fact, the evidence of negligence against the manufacturers was overwhelming and their defence was a fraud that never had to be tested. The benzodiazepine scandal is the outcome of a deliberate strategy by the manufacturers. Mass benzodiazepine addiction is not something that just happened, it was the intended result of a world-wide benzo strategy devised by Wyeth and Roche.

    Wyeth and Roche released co-ordinated information on benzos in each country according to the strength and vigilance of the regulatory authorities in that country. Ativan first appeared in the UK in 1972 with warnings well below the level of information in the possession of Wyeth. The minimal warnings and the exaggerated indications for Ativan increased prescribing and therefore sales and profits for Ativan. The addictiveness of Ativan works a ratchet effect. Any unwary patient who is prescribed Ativan for a month or more can become an addict for decades and thus a steady customer for Wyeth drugs.

    Wyeth deliberately issued defective information on Ativan in their UK Data Sheets. This defectiveness can be shown by collating and cross-referencing Wyeth's own documents:

    1. clinical trials;

    2. worldwide Wyeth Benzo Data Sheets;

    3. Wyeth benzo adverts in USA medical journals;

    4. information provided by Thomas Harry, Wyeth Medical Director and Whistleblower.

    (i) Ativan Clinical Trials

    The Wyeth Ativan Clinical Trials were poor quality and short term; none provide reliable evidence that Ativan is safe, several of the Ativan trials report what were to become the classic Ativan problems.

    The earliest Ativan trial sponsored by Wyeth was conducted in a US prison in 1970 and is by HW Elliot (1). This was a one-tablet only, one day trial. Subjects are reported with:

    EEG modification to alpha rhythms; 'minimal' changes in cardiovascular reflexes; being unable to repond to their spoken names; unable to walk; instantly falling asleep; amnesia; post treatment depression of CO2 response; unable to complete a test because of fear; EEG - loss of alpha rhythm, burst of spindles; cardiovascular problems.

    Cross-referencing this trial with the 1974 UK Ativan Data Sheet (2) shows Wyeth withheld vital safety information from the Data Sheet. Omissions from a Data Sheet are a simple but effective way of sabotaging the mechanism for drug safety put in place by the 1968 Medicine Act.

    De Buck 1972 trial 'Clinical Experience with Lorazepam' (3) is also Wyeth sponsored. This trial reported epileptic seizures in two patients (of 30) when withdrawing from Ativan after three weeks ingestion. Epileptic seizures are an extreme withdrawal symptom and were clear warnings of the highly addictive nature of Ativan.

    The appropriate warning for a specific Adverse Drug Reaction (epileptic seizure) that the De Buck trial should generate does not appear in the UK Ativan Data Sheet. Neither does an appropriate high level addiction warning.

    The deeper question consequently arises - did Wyeth provide the CMS/MCA with all available safety information when they applied for an Ativan Product Licence? My answer is most definitely not but, as long as Wyeth's Ativan Drug Licence Application remains secret, Wyeth will deny any wrongdoing. A DLA application is the country's most secret document, and it remains secret in perpetuity.

    These discrepancies - between the trial results and the Data Sheets - are not administrative details or secretarial problems. The withheld trial results correspond closely to the injuries suffered ever since by unwary ingesters of Ativan.

    The discrepancies are at the heart of a multi-million pound drug swindle perpetrated in the UK by Wyeth. It is a swindle that has condemned 1000s in the UK to the misery of Ativan addiction and the slow incurable poisoning of their bodies organs and nervous systems.

    Up until now Wyeth have escaped responsibility by hiding behind the shield of a supposedly all powerful 'right' to commercial confidentiality.

    Recommendation (during enquiry)

    I strongly recommend that the Health Select Committee root out the truth by subpoena of the DLA for Ativan, in particular the Summary Basis of Approval (SBA) which is the section dealing with safety as opposed to commercial information.

    ii) Wyeth's Benzodiazepine Advertisements

    Oxazepam (Serax), Wyeth's first benzo, was launched in the USA in 1965. All benzodiazepines are analogues of one another. This means they are not just similar to one another but closely similar. Any warning or information provided for Oxazepam (Serax) is applicable to Ativan. Particularly when Ativan is twenty times the strength of Oxazepam (Serax).

    Oxazepam (Serax) prescribing information (FDA approved) is provided in a Wyeth advertisement in Psychosomatics, September 1965 (4), one of a series of advertisements that appeared in USA Medical Journals. The nightmare list of side-effects associated with this low-strength earlier product can be compared with the innocuous warnings (CSM/MCA approved!) provided by the UK Ativan Data Sheet nine years later in 1974.

    Similarly, when Ativan itself was launched in the USA in 1978 it was done so under a different higher-level set of warnings (JAMA 1978) (5).

    Ativan is described in the USA as a potent and dangerous compound. Ativan is described in the UK as clean, mild and efficient. US consumers and prescribers have proper addiction warnings, pregnancy and lactation warnings, liver function warnings, etc. Generally, it can take ten or fifteen years for safety warnings to travel from the USA to the UK Data Sheet.

    iii) Wyeth's Ativan Data Sheets

    The origin of drug information in the UK is the Data Sheet. It is a legal document required by the Medicine Act 1968. Wyeth consistently issue a lower level of information on Ativan in the UK Data Sheet, lower than the information provided in the equivalent year Data Sheet for Ativan in the USA, Canada or Australia. I have provided copies of 1978 Ativan Data Sheets (6) for the Committee to examine - and I have complete Ativan Data Sheets collection for those countries.

    Recommendation (during enquiry)

    Senior Directors of John Wyeth should be summoned before the HSC to explain these safety information discrepancies and to take responsibility for the results of these discrepancies.

    Recommendation (during enquiry)

    Unpublished clinical trials for Oxazepam (Serax) and Ativan should be subpoenaed from John Wyeth.

    iv) Whistleblower Statements

    During the benzodiazepine litigation, two ex-Wyeth Medical Directors made detailed and incriminating statements against their former employers. They are Dipak Malhotra and Thomas Harry (7) who was responsible for the development of Ativan. Thomas Harry states clearly and consistently that Wyeth were fully aware of the problems with Ativan and that for commercial reasons they did not warn doctors or patients.

    These statements were taken by my former solicitor Graham Ross. So far this document has been swept under the carpet and ignored by Government and regulators.

    Recommendation (during enquiry)

    That Graham Ross (8) and the original Thomas Harry statements and authentication be subpoenaed by the HSC.

  3. The Ativan Licence

    My submission is that Wyeth did not tell the truth when they made their Ativan Licence Application.

    Furthermore, the licensing procedure that was applied to the benzodiazepines, and in particular to Ativan, was not the vigorous assessment procedure that has been claimed by the CSM/MCA. Far from it.

    Most of the benzodiazepines - Valium, Librium, Mogadon - were on the market before the Medicine Act of 1968. These drugs were issued "Licences of Right". The Licences of Right were a registration procedure and involved no assessment of safety or efficacy. Assessment was deferred to a future review by the CRM. Significantly, those reviews did not occur until 1983/84. By then the damage was done, the huge benzo addict population had been created and still exists to this day.

    The first application for a full Benzo Product Licence was for Ativan in 1972. The relevant safety requirement was that the drug should be no less safe than other drugs indicated for the same condition (ie, the existing benzos). This was not an objective standard, it was a comparative standard and it was a comparison to Roche's benzodiazepine products that had not yet been assessed for safety themselves. As Ativan had secured a full Product Licence it was not even subject to the future CRM review. Can it be said that Ativan was ever fully assessed for safety by the licensing authority?

    The senior members of the licensing authority have what has been quaintly described as a conflict of interest - they receive large amounts of money from the drug companies they regulate. In 1996/97, for example, ten members of the CSM/MCA declared financial links with John Wyeth and Brother.

    Wyeth is a subsidiary of American Home Products. In the 1970s the USA Securities Exchange Commission offered US corporations an amnesty from prosecution in return for disclosure of corrupt payments. American Home products (9) declared from 1971-75 corrupt payments of $3.4m in 41 different countries by their subsidiaries and divisions.

    AHP's auditors, Arthur Andersen, submitted form 8K in 1975:

    "These payments were intended to further business with government agencies or to obtain action on necessary government clearances". (Item 13).

    "Non-commission type payments were made in a number of countries to foreign government employees primarily in connection with the granting of required government approvals". (P4).

    Recommendation (during enquiry)

    That Wyeth and the MHRA should be questioned on all aspects of the Ativan Licence application, its truthfulness and the process applied. That Wyeth be questioned on involvement in corrupt payments in the UK.

    Recommendations (for actions)

    That the MHRA be disbanded. That it should be replaced with an independent body. That clinical trials should be supervised by an independent body. That there should be no retainers from the pharmaceutical industry to regulators. There should be significant lay membership and an end to secrecy.

    Wyeth have plenty of form when it comes to avoiding regulatory control and manipulating information on safety and efficacy. Dr Rheinstein of the FDA in the United States wrote a regulatory letter to Wyeth-Ayerst in 1989 telling them they had an "intolerable record of compliance with the law" (on drug promotion). (10).

    Wyeth-Ayerst had "in case after case…disseminated promotional materials that are clearly false and misleading" indicating a "general and wilful disregard for legal and regulatory limitations upon drug promotion".

    Dr Rheinstein told Wyeth-Ayerst that a 1989 advertisement for the heart drug Cordarone was "clearly intended to minimise the hazards of the drug and emphasise the drugs efficacy".

    Dr Rheinstein's Office of Drug Standards issued 18 notices of violation to Wyeth-Ayerst concerning drug advertising and labelling in 1988/89.

    In 1999, AHP had to pay $4.85 billion compensation in the 'Fen-Phen' litigation to 5.8 million ex-users who suffered heart-valve damage. The drug was marketed through Wyeth-Ayerst, it was linked to serious lung disease and leaky heart valves. Wyeth-Ayerst were found to have concealed this information. Settlements included medical care and monitoring for the victims, paid for by the manufacturers. (11)

    Also in 1999, Wyeth Laboratories were convicted by the Supreme Court of New Jersey of failing to warn adequately of side-effects associated with the contraceptive device Norplant.

  4. Government Control of Psychotropic Drugs

    In 1997, the campaign group 'Beat the Benzos' was formed by Barry Haslam, Phil Woolas MP, myself and others. We hoped that if we brought the benzo problem to the attention of the Government that appropriate action would be taken across the various government departments. There has been no action. In my opinion the strength and influence of pharmaceutical companies extends into Government.

    Ministers come to the complex subject matter of psychotropic drugs as lay people and move on regularly, this produces an over-reliance on advisers who are presumed by Government to be unbiased. There is no balance or brake on these advisers. The Government takes advice on the psychotropic drug problem from people who help to sustain the problem, namely the psychiatric profession, specialised prescribers of drugs. The psychiatric profession has both feet firmly in the camp of the manufacturer with whom they share the common desire to extend the use of psychotropic drugs.

    The advisers on psychotropic drugs claim possession of "The Science" and that thereby Ministers can believe that their policies are underwritten by science. "The Science" they possess is actually information emerging from the pharmaceutical companies and the clinical trial system - also known as "The Evidence". The psychiatrists claim the exclusive ability to understand and interpret this information and they insist that it is true. What anyone else says, for example the patient or ex-patient, is excluded as 'anecdotal evidence' as opposed to their 'scientific evidence'. The government experts define their own expertise. They create a monopoly for their own extreme viewpoint. The policy outcome is a non-policy of minimum regulation and inaction, the ideal environment for drug addiction to take root and spread.

    In our case the 'Beat the Benzos' group attended a meeting in April 2003 with the Home Office Minister Bob Ainsworth MP. We asked Bob Ainsworth to consider re-scheduling and re-classifying benzodiazepines and he invited us to prepare a submission (12) to the Home Office Advisory Council on the Misuse of Drugs (ACMD), which we did. The submission was referred to the Technical Committee of the ACMD which is chaired by Professor David Nutt, a key Government adviser and regulator. The ACMD was set up by and derives its power from the Misuse of Drugs Act 1971. The Act states (Section 2) that class and schedule are to be determined by the drugs level of misuse and the harmful effects to the public thereby caused.

    We submitted that on any relevant criteria benzodiazepines are one of the most harmful of drugs and are wrongly classified and scheduled. Example of criteria that are used in the submission are:

    1. the number of benzo related deaths;

    2. the number of people affected 1.5m+;

    3. the magnitude of addiction;

    4. the duration of addiction;

    5. the social cost of benzo addiction;

    6. the suffering of addicts and its immorality.

    It emerged that in fact the original scheduling (1986) and classifying of the benzos was not based on a risk assessment. The concern in 1986 was to conform with international legal obligations created by a UN Convention.

    The ACMD has not so far carried out, in fact, a risk or safety assessment of the benzos. We received a refusal letter from the Home Office in April 2004.(13). The ACMD do not respond to any of the evidence, arguments or suggestions put forward in the submission. The ACMD make an assertion that re-classifying and/or re-scheduling benzodiazepines would be likely to be ineffective in curtailing their misuse but gave no reason.

    Professor Nutt has financial links with John Wyeth. In the 2001 CSM Declaration of Interest, Nutt declares an 'Honorarium' and a non-personal grant from benzo manufacturers John Wyeth. He did not declare that interest in his dealings with us.

    Professor Nutt chaired a recent CSM/MCA/MHRA review on SSRIs which found them to be safe. He was later revealed by the Guardian to have financial links to GlaxoSmithKline, as had two out of three of the other members of the review committee.

    Professor Nutt sets out his own position on benzodiazepines in his paper "The Psychopharmacology of Anxiety". (14). Professor Nutt recommends prescribing practices that directly contradict:

    1. CSM advice and addiction warning.

    2. Data sheet addiction warning.

    3. The Department of Health stated position.

    Professor Nutt advocates treatment for 6-10 weeks, 6 months, 1-2 years and life-long use - "some patients appear to require maintenance benzodiazepines".

    In this medical paper, Nutt also takes the trouble to present the manufacturers' account of the litigation. Nutt wrongly claims that "it was decided by the presiding judge that the case for benzodiazepine dependence causing real damage has not been made".

    At the original meeting with Bob Ainsworth and in a letter dated 11 July 2003 from the ACMD, it was indicated to us that our submission would be assessed by a point scoring system that would measure levels of harm. Professor Nutt did not apply that system. I have requested the minutes of the ACMD Technical Committee meeting of 2 October 2003 but have been refused for "reasons of confidentiality".

    The processing of our ACMD submission on benzos followed the pattern of benzo drug regulation set by the CSM/MCA. The case against drugging is not addressed, it is ignored and avoided by bureaucratic manoeuvering. There is extreme secrecy and no engagement between the regulator and consumer. The complete absence of a safety assessment is revealed. Power and control is concentrated in the hands of Professor Nutt, an all powerful benzo-enthusiast who claims expertise and is in the pay of the manufacturers.

    Recommendation for enquiry

    To examine Professor Nutt. That the scheduling and classification of benzos be properly assessed by an independent and open process.

    Beat the Benzos final attempt to change the benzodiazepine status quo was a meeting with Health Minister Rosie Winterton in 2003. We outlined our concerns and suggested solutions. Rosie Winterton asked for more information and told her advisers she had not been kept informed or had been wrongly informed of the situation. However, the arrangement was unexpectedly ended in January 2004 when we received a letter that shut the door in our face and re-affirmed Department of Health policy. That policy is:

    1. To exclude any consideration of benzo damaged people for aftercare by setting the parameter "the main focus is to prevent addiction in the first place".

    2. To provide no research into and no treatment for benzodiazepine injuries.

    3. To ignore the problem - there is no quantification, no figures, no statistics.

    4. To claim withdrawal facilities are available when they are not.

    5. To blame over-prescribing on GPs and psychiatrists as if these employees are nothing to do with the Department of Health. The Department of Health makes no effort to enforce benzo prescribing guidelines. As long as guidelines are not enforced prescribers will continue to over-prescribe in dosage, in time and by polypharmacy.

    6. To pretend the benzo problem is a mental health problem - it is not, it is a problem of physical drug addiction and drug toxicology.

    Chief spokesperson and letter writer for the Department of Health, and this policy, for the last several years has been Dr Anna Higgitt who styles herself as Senior Policy Adviser on benzodiazepines. It is a policy of denial and inaction which provides the perfect environment for psychotropic drug addiction to flourish.

    The pharmaceutical industry have created the benzodiazepine problem and have left it in the lap of the Department of Health. The Department of Health will not tackle the problem because:

    1. The Department of Health has been compromised by years of denial and cover-up.

    2. Tackling the benzo problem involves confronting the pharmaceutical industry which they will not do.

    3. The apparent cost of tackling the benzo problem appears massive - benzo withdrawal facilities, medical treatment and compensation payments - but is not massive when calculated against the social cost of benzo-addiction.

    4. Melanie Johnson MP, Minister of Health has registered a financial contribution of £20,000 from Hoffman La-Roche. (15).

    Recommendations for Action

    1. Establishment of benzo withdrawal facilities nationwide including clinics, self-help groups and a help line.

    2. Prescribing guidelines to be enforced.

    3. Compensation for benzodiazepine injuries with no-fault compensation scheme.

    4. Prosecution of negligent manufacturers by a government agency.

    5. Medical research into benzo injuries and after-care for victims - alternative, non-drug treatment.

    6. An independent and open licensing procedure.

    7. Education of the medical profession on psychotropic drugs.

    8. New government experts, adviser and regulations.

    References

    1. 'Central Nervous System and Cardiovascular Effects of Lorazepam in Man'. HW Elliot, Clinical Pharmacology and Therapeutics 1971

    2. UK Ativan Data Sheet, 1974

    3. 'Clinical Experience with Lorazepam…', R De Buck, Current Med Res and Opinion 1973

    4. Serax Advert Psychosomatic, Sept 1965

    5. Ativan Advert Journal of the American Medical Association, 1978 v 240

    6. Ativan Data Sheet, USA 1978; Australia 1978

    7. Whistleblower Testimony: Thomas Harry

    8. Letter: Graham Ross to Neil Fearn

    9. Amnesty Disclosure on Corrupt Payments by AHP to SEC

    10. SCRIP World Pharmaceutical News, 1990

    11. Fen-Phen Litigation from Internet

    12. ACMD Submission, 2003

    13. Home Office Refusal, 2004

    14. The Psychopharmacology of Anxiety, Professor Nutt

    15. Private Eye

    Declaration

    Name: Michael Behan, Beat the Benzos
    Date: 30 August 2004

ADDENDUM

October 29, 2004

This is an addendum to my earlier submission: "THE BENZODIAZEPINES, JOHN WYETH AND ATIVAN". This further submission is necessary for two reasons. Firstly, in response to clarification made by the HSC of its terms of reference. Secondly, to incorporate into the submission information on an ATIVAN data sheet warnings introduced by Wyeth in Canada in 2004.

  1. TERMS OF REFERENCE

    The HSC members have indicated their interest in recent and current problems. Richard Brook of Mind has in his evidence referred to the Benzodiazepine problem in the past tense.

    "Nine years ago I was involved in the same issue around drugs like Valium and That’s Life, which most people recall, so there is a long history here." - Richard Brook 14/10/04 p23 of HSC TRANSCRIPT

    Unfortunately this remark gave an incorrect impression that the Benzodiazepine problem is old or has been resolved. There is also a general misconception that the Benzodiazepine problem is now a prescriber problem rather than a problem with the pharmaceutical companies. In my view, the Benzodiazepine scandal is very much a current problem and is the result of the excessive and continuing influence of the Pharmas over the UK regulatory process and specifically the compilation of Data Sheet Information.

    The Benzodiazepine and SSRI scandals have followed similar patterns.

    Stage one of both of these scandals involves the development and marketing of the drug, the clinical trials, the Licence Application, the targeting of an appropriate illness, the hype, the launch and the broadening of indications.

    Stage Two is the Backlash stage: patient complaints, litigation, questions in the media and the manufacturers defensive response - denial, delay, blaming the patient, the solicitors, the media and the stigmatisation of the victims.

    The SSRI scandal has faltered at this point. Secret information has been uncovered by Professor Healey and Richard Brook and the safety review process been discredited. However, in the case of the Benzodiazepine the manufacturers, Wyeth and Roche Products were able to overcome the safety review procedure and defeat mass litigation.

    By negotiating these two obstacles the manufacturers were able to achieve a third stage of success where their product is now firmly established and secure on the market. Injured patients can be stonewalled by reference to the licensing authority decisions.

    Several factors help the Benzodiazepine scandal to continue: bad prescribing habits and addiction- 1.5 million Benzodiazepine addicts are driven each day to make sure they have their drugs. However, the main strength of the Benzodiazepine manufacturers is their ability to control, through subservient and weak regulators, the product information in the Benzodiazepine Data Sheets.

  2. THE ATIVAN DATA SHEET: Perverse and Defective

    The UK Ativan Data Sheet, and all the Benzodiazepine Data Sheets are an abuse of the Data Sheet system. Data Sheets are intended, and believed by prescribers to list unusual but theoretically possible ADRs - 1/100 or 1/1 000 chances.

    There are many hundreds of Ativan ADRs covered by the generic terminologies used in the Ativan Data Sheet. Some of the ADRs are unlikely possibilities but many are probabilities and others are certainties. The inevitable outcome of the ingestion of Ativan is a bizarre and crippling collection of these physical and psychological illnesses. The patient is locked into the Ativan ADRs by his physical addiction to the drug. Mike Burkinshaw, a constituent of John Grogan, M.P for Selby, is in this very predicament - physically addicted, unable to withdraw and suffering 73 ADRs.

    The perversity of the Data Sheet is no accident; the manufacturers and the MHRA have colluded to turn the Data Sheet system on its head. The Ativan Data Sheet is not a warning but a prognosis of the patient’s future Ativan induced illness.

    Furthermore the Ativan UK Data Sheet is not only perverse but also defective. The manufacturers deliberately withhold vital safety information from the UK Ativan Data Sheet.

    1. Death Warning

      The 2004 Wyeth Canadian Ativan Data Sheet contains an ADR Death warning: "Use of benzodiazepine, including lorazepam, may lead to potentially fatal respiratory depression".

      This warning is not included in the 2004 Wyeth Ativan Data Sheet. This Canadian warning is a prescribed dose warning not an overdose warning, and can only be based on scientific evidence that is within the knowledge and control of Wyeth. What is that evidence? how long have Wyeth had that evidence and why has it not been reported to the MHRA as required by the Medicines Act 1968?

    2. Seven Day Addiction Warning

      The 2004 Wyeth Canadian Data Sheet also contains a seven-day addiction warning. The dosage information warns:

      "Withdrawal symptoms can appear following cessation of recommended doses after a little as one week of therapy."

      Wyeth have also provided the warning in Australia since 1999 yet no such warning appears in the UK. Again the Canadian and Australian warnings must be based on scientific evidence. What is that evidence, how long have Wyeth possessed that evidence and why have they not informed the MHRA?

    3. Ativan Withdrawal Information

      Ativan is so addictive that, in order to successfully and safely withdraw, a long tapering to zero period is required (6-18 months in my experience) from the prescribed dose. The Australian Data Sheet goes someway to provide relevant information and has suggested since 2001 a tapering period of up to four months. Again this information must be based on scientific evidence but this has not been provided to the MHRA.

    4. Damage

      No Ativan Data Sheet warns in any jurisdiction that ADRs - side effects and withdrawal symptoms - do not necessarily disappear after patients stop ingesting Ativan. ADRs Ativan may reverse but can also persist as long term and permanent (physical, neurological and psychological) damage.

    5. No Cure

      No Ativan Data sheet in any jurisdiction warns that there is no known cure or treatment for Benzodiazepine damage.

  3. CORRUPTION

    "Willing to act dishonestly in return for money or gain." - Oxford English Dictionary

    Ativan is:

    1. Highly addictive

    2. Poisonous
    3. Kills people
    4. Has efficacy approaching zero

    Yet the MHRA has:

    1. Issued a Product Licence for Ativan

    2. Conducted a review and found Ativan safe
    3. Continued to issue perverse and defective Ativan Data Sheets for thirty years

    How can this happen?

    The MHRA employs thousands of people - highly qualified and experienced academics, scientists and experts.

    The regulators take multiple retainers from the pharmaceutical manufacturer, share options, grants and retainers. This is not a conflict of interest this is corruption, large scale and systematic of the MHRA, its personnel and its function.

  4. SUMMARY

    The Benzodiazepine scandal is not old or nothing to do with the Pharmas, it has simply rumbled on to a more advanced and successful third stage. The perverse and defective Ativan Data Sheet is not an accident or a mistake - it is the product of collusion between the Pharma and the Regulators.

    The final outcome is a huge and unnecessary danger to public health. In this way the Benzodiazepine problem is a current problem of pharmaceutical industry influence over the MHRA.

  5. RECOMMENDATION

    1. The MHRA is a non-stop party for corrupt professors and should be shut down.

    2. Withdraw Ativan.

    3. An independent review of the safety and efficacy of all other Benzodiazepines.

    4. That UK regulators be compelled to cross reference with Canadian, Australian and other Data Sheets and thereby provide at least the same standard of information in the UK.

    5. A public enquiry into the Benzodiazepine scandal.

M. Behan
29th October 2004

Michael Behan · 34 Greenside Road · Shepherds Bush · London W12 9JG · Fax: +44 (0)208 740 7340

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