Select Committee on Health Written Evidence


Memorandum by APRIL (Adverse Psychiatric Reactions Information Link) (PI 60)


  The charity collects and collates information from health professionals, the public and from medical literature about psychiatric and neuropsychiatric adverse drug reactions (ADRs), and alerts doctors and professors to inquiries such as this one.

  The chair Mrs Millie Kieve who, as part of a Millennium Award in 2000, studied suicide prevention and attended meetings and conferences in the UK and the USA. Many leading specialists in the field of ADRs support the charity by speaking at conferences and offering advice and information. All the information in this submission is from knowledge and information gained since Karen Kieve died following a series of adverse reactions to a variety of medicines and anaesthetics in 1995.

  The charity held a major conference in 2001 and will hold one 4 November 2004.

  Meetings are planned at the House of Commons and the Royal Society of Medicine. All this work is done with little funding and no paid staff.


    (a)  The pharmaceutical industry had a higher that expected trade surplus of £3.6 billion in 2003 (ABPI Press Release 19 May 2004) The industry spends very little of their profits on new drug development.

    (b)  A great deal of money is spent on producing what are known as "Me Too" drugs to break into the market of competitors. Ingredients of established drugs may be altered or just the name changed. Sometimes old drugs may be directed at new conditions not included in the original licence application. For example Duloxetine was used for urinary tract infection and will be marketed as an antidepressant. Prozac became Sarafem and Wellbutrin became Zyban.

Recommendation for action by the Government

    (a)  There should be a mandatory obligation for the industry to spend a designated proportion of profits on research for treating rare disease and finding cures for iatrogenic disease and other long-term medical conditions.

    (b)  New licences could be restricted to drugs proven in clinical trials to be more effective or safer that similar drugs already on the market. Only drugs with improved efficacy or safety in comparison with existing licensed drugs. at equivalent doses, should be considered.


    (a)  Favourable results of clinical trials have been selectively published and unfavourable results suppressed.

    (b)  Serious adverse drug events (SAEs) during clinical trials are not disclosed.

      The SAEs that occur during the clinical trials are the confidential information of the pharmaceutical company. James Wright, Professor of therapeutics and pharmacology at the UBC Canada presented some startling information from clinical trial data that he has researched for Zyban, cox 2 inhibitors and statins. I have his presentation and he has given me permission to share this information so it could be viewed by the Health Committee.

      Information about the agitation suffered by people withdrawing from Seroxat in a pre licence trial, was not disclosed by GSK in pre licensing data. Dr David Healy found this evidence in the GSK files in their premises, during his research when he was allowed access for legal reasons.

    (c)  There is no research into why adverse drug reactions (ADRs) occur and no research to discover the causes of iatrogenic disease.

    (d)  There are no NHS clinics offering specialised help for iatrogenic illness or support for medication withdrawal. Such clinics could run research trials into ADR causes. NECA was the only dedicated withdrawal clinic run by Professor Heather Ashton to support people withdrawing from benzodiazepines.

    (e)  Too little research is carried out in the area pharmacogenetics.

Recommendation for action by the Government

    (a)  All clinical trials should be pre-registered and ALL results given to the regulators. All clinical trial data should be in the public domain. Freedom of information should apply. Undisclosed information leading to harm of patients should lead to legal proceedings.

    (b)  Serious Adverse Events (SAEs) should be disclosed to the regulators.

    (c)  Research into ADRs should be mandatory.

    (d)  Clinics for medication withdrawal support and for monitoring sufferers of iatrogenic disease should be government funded. Information and data from these clinics could provide valuable research material.

      Professor Heather Ashton estimates 200,000 involuntary benzodiazepine addicts in the UK. Many people need support to withdraw from SSRI antidepressants.

    (e)  Enzyme deficiencies lead to ADRs and death, yet the "one size fits all" method of drug prescribing is costing the NHS a great deal of money due to the damage to health of thousands of patients. Patients suffering ADRs could be tested for enzyme deficiencies.

      Preventative initiatives could include enzyme and endocrine tests, which could possibly identify groups liable to suffer ADRs.

      The Nuffield Bioethics Pharmacogenetics consultation results should be studied.

  The network of genetic centres in which the Government has invested, to investigate disease, should not just be to facilitate tests for genetic disease as at present. They could test patients for enzyme deficiencies to assess drug tolerance.


(a)  Information

    I.  Patient Information Leaflets (PILs) do not contain enough information and are often unclear with ADRs being hidden in the small print. The fact that a drug may cause depression or suicidal ideation is often not stated.

    II.  Consent forms would ensure that the prescribing clinician explained the risk benefit to a patient, and the advisable safeguards for taking and withdrawing from medication.

    III.  Newly discovered ADRs from Yellow Card signals or Prescription Event Monitoring (PEM) studies are not put on the PILs, for many years or not at all in some cases.

    IV.  Drugs dispensed from bulk supply are often given to the patient in a brown bottle without a PIL. Hospital patients are seldom given information.

    V.  PILs do not disclose previous names under which the same drug was marketed.

    VI.  Hospital libraries have been found from personal research to lack vital ADR manuals and books. Even small publications such as the Consumer Assn Drug and Therapeutics Bulletin and the CSM Latest problems in pharmacovigilance are unavailable to most medical and nursing students.

    VII.  There is currently no system to keep coroners regularly informed about new ADR alerts or lists of drugs which affect a person's driving ability.

    VIII.   Patients receiving dental treatment are not given PILs for drugs used during treatment.

Recommendation for action by the government

    I.  PILs from all manufacturers for the same or similar products, should be compiled and approved by independent scientists and not by sales people. Information and class warnings should be standardised, with nothing missed out that could be detrimental to the patient's health. If a drug may cause suicidal feelings the PIL should state this. If a drug causes depression it should state this. "Tell your doctor if you have ever suffered from the following" does not explain that a drug can CAUSE the following . . .

      The PILs should be reviewed by patient groups as well as specialists. The colour and size of print should be readable. It should be available in different languages, with a clear heading "POSSIBLE ADVERSE EFFECTS" on every PIL.

      WARNINGS ABOUT THE RISK OF ALCOHOL with medicines should be put on PILs, in the box and also on the outside of the box. Any food or fruit juice that is contraindicated should be shown on the box and marked clearly on the PIL.

      PILS should include the need to drink a full glass of water at least with medicines. The reason for this should be given which is to prevent damage to the oesophagus or kidneys and help prevent blood disorders.

    II.  The provision of consent forms in several languages should be considered for all long term medication. People are still informing APRIL of the fact that they have been taking cortico-steroids having received no warning about the risk of osteoporosis or the risk of suddenly stopping steroids. Mental depression caused by medication is being regularly treated with antidepressants without patients being informed their depression is medication induced. Depression is a serious condition and often triggered by medication ADRs. APRIL can provide testimony from hundreds of patients who in most cases failed to persuade their doctors to send in Yellow Card reports. Many of whom were prescribed antidepressants without having the original drug stopped. (Zoton and Dianette are often named as drugs causing depression, which lifts once the drug is stopped.

      Marketing departments change the wording on PILs and adverts, without consulting the medical staff, I was informed by an MP who used to work for an advertising agency and by a pharmacist working for pharmaceutical companies.

    III.  Prescription Event Monitoring Studies (PEMs) ignored by MHRA and the manufacturer.

      The Pharmacovigilance of Mirtazapine: results of the DSRU prescription event monitoring (PEM) study on 13,554 patients in England. This showed evidence of serious ADRs which are still not on the drug information or included in the CSM bulletin "Current Problems in Pharmacovigilance". The following results: Agitation (73), aggression (70), rash (20), hallucinations (13) and abnormal dreams (31). were all unlabelled AES. The Drug Safety Research Unit (DSRU) PEM Journal of Psychopharmacology 2003;17(1):121-126.

      Doctors should be informed individually by the pharmaceutical companies of such information as found in the DSRU PEM study and in other studies highlighting ADRs.

      The Committee on Safety of Medicines (CSM) should include signals of unlabelled ADRs information from DSRU PEM studies in their publication "Current problems in pharmacovigilance".

      The MHRA should have mandatory power to add information to Patient Information data and PILs, the ADRs reported in studies, or on Yellow Cards reporting forms. Dr June Raine told me that the initiative has to come from the pharmaceutical company and this is not a satisfactory arrangement.

    IV.  Bulk supplies leads to many drugs being dispensed and given to the patients without advice or information due to lack of PILs being supplied by the manufacturer.

      Pharmaceutical companies should supply enough PILs for every patient to receive one with their prescription from bulk supply dispensing.

      Hospitals should provide the patients or their families with information about the drugs they intend to prescribe. Patients should always be provided with PILs to take home from the hospital.

    V.  Zyban also known as buproprion and wellbutrin has been documented for years as a drug that may cause seizures. Anyone prescribed this drug as an anti-smoking aid, in England would not necessarily know they were being given a well know antidepressant known as wellbutrin. This information is not on the patient information leaflet (PIL)

      Prozac being re licensed for PMT under the name Sarafem may be given inadvertently to someone who should not be given SSRIs. All names that the drugs were previously marketed under should be on the PIL.

    VI.  The Government should make it a requirement by law that all available information on ADRs should be in every hospital library and kept up to date. Libraries should be inspected, possibly by patient volunteers who could be given a list of books to look for. Medical and nursing students should have easy access to the information available.

    VII.  Coroners should have access to information and independent advice about the role medication may have played in a sudden death. This charity APRIL is a resource but there should be an official resource for all coroners, many of whom have no medical knowledge.

    VIII.    A coroner informed me of a dental death where the fact that dental treatment was involved, was not even put on the death certificate. All dentists should be informed that patients are entitled to a PIL by law.

(b)  Promotion

    I.  The Royal Institution of Great Britain has been holding a series of talks and meetings sponsored by Novartis at 21 Albermarle St London W1 aimed at audiences consisting of the general publiic, since 2001. These are still continuing, so must be of benefit to Novartis. The publicity for the talks may not mention specific drug promotion, or the fact that Novartis are sponsoring the talk, but the picture in the lecture theatre my be different.

      I attended one of the Novartis meetings on 24 May 2001 titled "Schizophrenia". At the side of the speakers was a large promotional poster.

      The meeting was promoting early diagnosis, early drugging and specifically was singing the praise of Clozapine, the Novartis blockbuster drug for schizophrenia.

      I heard Dr Adreanne Revely state that Clozapine has no side effects. I also heard her state that the earlier you administer drugs the better the outcome. The emphasis was on finding evidence of schizophrenia in children and starting Clozapine as early intervention. She said there is a better outcome the earlier you administer the drugs. Professor Robin Murray was there to support her statements.

      I was with psychologist Rufus May and will be willing to give oral evidence of the content of this meeting which was blatant drug promotion to the masses. Novartis had intended to use a film of the meeting as promotional material, on the internet but this intention was apparently thwarted by the close detailed questioning by Rufus May and myself.

    II.  "Europe's premier forum for marketing and communications professionals in the pharmaceutical industry" was held in London on 10 and 11 May 2004.

      The Forum brochure was quite disturbing and illuminating about the marketing tactics of the pharmaceutical industry. and gives a hint of how unscrupulous the industry is in promoting drugs and disease awareness.

  On Day One talk titles included:


    *  Understanding and segmenting patient populations.* Building profitable long term patient relationships etc


    *  Do we really want disease awareness campaigns? * Have they got a future? etc


    *  Why your marketing to consumers needs to be trashy, have a reading age of 9, lots of bold colours and still be legal.

  On Day Two Tuesday talk titles included:


    *  Brands as business assets; brand development and its role in the pharma industry

    *  The Zantac-Tagamet example: optimisation of a blockbuster etc


      A profile for speaker Philip Atkinson International Consumer Marketing Manager for Roche Pharmaceuticals, Switzerland it states at the end of the paragraph. "Philip's specific interest is how to drive patient demand for healthcare products."

    (You can download the pdf brochure at then click on Programme and when the programme page shows the participants, click on the small blue arrow which states " click here to download brochure as a pdf.)

    III.  FREE HOLIDAYS AND ENTERTAINMENT are provided and doctors feel obliged to order expensive products from their host. Direct promotion of drugs to health professionals is a reason for the provision of perks in the way of free food, entertainment, holidays in luxury hotels and trips abroad. This is still happening yet well hidden.

    IV.  PATIENT SUPPORT GROUPS are sometimes set up by pharmaceutical companies and others are financially supported by them. This leads to the promotion of drugs in the groups journal and meetings where the drugs are promoted and little attention paid to warnings about ADRs. On a web site of a leading charity dealing with anxiety and supported by two pharmaceutical companies, there is a list of drugs used to treat the condition, no link to discussions about risk benefit or ADRs. Named doctors and professors on the anxiety site I viewed are known declare that they receive income from pharmaceutical companies.

    V.  CME SEMINARS AND MEETINGS sponsored by pharmaceutical companies should be reviewed. Clinicians are sometimes paid to promote drugs in meetings and conferences.

    VI.  CONFERENCES are so heavily sponsored by the pharmaceutical industry and the representatives are everywhere promoting and standing around looking at the doctors who, I believe feel intimidated and therefore do not ask relevant questions about ADRs during conference sessions. Very little discussion of risk benefit or ADRs took place at the British Association of Psychopharmacology annual conference, I attended. In a talk about suicide and antidepressants, I was the only person to ask about incidents of akathisia (drug induced physical and mental agitation that often leads to suicide).


      The provision of free lunch for GP practice staff in return for listening to information about a drug still goes on I am told by a local health professional.

    VIII.  DRUG PROMOTION to POLITICIANS and using politicians

      Pharmaceutical companies employ lobbyists to influence politicians for the purpose of selling their products to the NHS.


Conservative Party Mental Health Summit Wednesday 29 October 2003 Portcullis House, Palace of Westminster FOOD PROVIDED BY ELI LILLY

      I attended a recent Conservative Mental Health Summit meeting at the House of Commons, the lunch was provided by Eli Lilly. The Mental Health Bill will promote the use of drugs and yet Tim Loughton MP or Liam Fox MP could not see this compromised the meeting at which Eli Lilly representatives were present.

      DRUG PROMOTION at the meeting by a speaker.

    At the same meeting, a person, ostensibly chosen as a patient spokesperson, promoted a drug in an obvious way during his talk. At the moment he said the name of the drug which he said had "helped his condition" I saw the Lilly reps of the look at each other smiling. The talk being about his experience as a mental health patient had no reason to include a drug name co-incidentally manufactured by Eli Lilly.

    IX.  The Promotion to and influence on the NHS

      THE NATIONAL SUICIDE PREVENTION STRATEGY FOR ENGLAND contains no reference to medication induced suicide or akathisia. The risk of suicide is 2.2 times greater for those taking SSRI antidepressants (stats from all clinical trials in the UK and USA Dr David Healy)

      THE NATIONAL SERVICE FRAMEWORK FOR DEPRESSION THE ELDERLY AND MENTAL HEALTH promotes the discovery of depression yet contains no reference to medication induced depression.

      ABPI Framework Will Help NHS And Pharmaceutical Industry To Work In Partnership To Help Patients

      Thursday, 15 July 2004

      A framework to guide joint working arrangements between the pharmaceutical industry and the NHS to benefit patients has been launched today by the Association of the British Pharmaceutical Industry (ABPI) in association with the NHS Alliance.

      The announcement comes as a survey shows that more than half of Primary Care Organisations (PCOs) now work in partnership with the pharmaceutical industry, rating medicines management projects as the most helpful area of working. Other top-rated areas are in team building and communication skills, implementing NICE guidelines and national service frameworks, and the training of nurses.

      "This survey shows how timely the issue of the framework guidelines is," said Dr Trevor Jones, Director General of the ABPI. "The NHS Plan and other recent publications from the Department of Health all point to the benefits that can come from a constructive engagement with the private sector.

      "In the spirit of this developing relationship, the ABPI has produced this document to introduce NHS managers and decision-makers to the benefits of partnership with the pharmaceutical industry"

      An NHS Confederation Diary for 2005 has on the front cover the words "supported by Wyeth"

        Within the diary it states "The confederation aims to bring industry and the NHS closer and to share expertise"

        The delegate pack for the NHS Confederation conference June 2004 is also sponsored.

      RECOMMENDATION FOR ACTION by the Government

    I.  The film of the Novartis meeting should be available and the Health Committee could review the film. The Royal Institution and other such "respected" bodies should be informed of their ethical duty to protect the public from blatant drug promotion by Novartis. A person I spoke to in the events department said they could not exist without Novartis and was not aware of the content of the meeting I attended. The government should provide funds to cover the cost of independent meetings at the Royal Institution so that a balance could be provided for the members and the public who attend RI meetings.

      Such promotional conduct should be carefully monitored and government representatives should attend all meetings sponsored by pharmaceutical companies to hear and see the blatant promotion of drugs to innocent audiences. Clozapine causes serious blood disorders, far from having "no side effects" as stated by Dr Revel, the patient has to have regular blood tests while on Clozapine. The drugs cause diabetes, obesity and heart problems and a young person may be helped by counselling and may not need long-term medication.

      The Government should look at the school curriculum which could include time to help children learn how to deal with life events and teach about life style, healthy living, the importance of healthy diet etc. Relaxation techniques and perhaps good breathing techniques and yoga could help people cope with life events.

      Politicians concerned about the breakdown of values and decent behaviour in society should look towards the top of industry and in particular to the pharmaceutical industry where such bad examples trickle down into society as a whole.

      The Government should halt the medicalisation of society. The promotion of disease should be stopped. New diseases such as "social phobia" are promoted to create a market for drugs.

    II.  Such conferences should be monitored by government "watch dog" representatives. The fact that no one hesitates to put such a blatantly crude marketing brochure on the Internet is a reflection of the complacency of the industry. The medicalisation of society is costing society in huge sales of medication and huge bills to pay for the damage they cause.

      The cost of ADRs may be up to 70,000 deaths a year in hospitals according to the NPSA. The cost runs into billions for extra bed days and no one has estimated the cost to society of ADRs in Primary Care.


      I have been told by one entertainer that the provision of his services was furtively hidden in fake invoicing for lighting and other such needs for so called "therapy" weekends where 120 people, GPs and their partners or practice nurses were feted in the best luxury hotels, given free drink and top class entertainment.

      The GPS had to attend one 10 or 15 minute talk on a topic such as asthma or migraine and had to sign a form saying that they had attended a "therapy weekend".

      The pharmaceutical company sales reps told my contact that they always got orders for the product the following week as the GPs could hardly refuse after being plied with food, as much drink as they could take and entertainment. For a few days.

      The products being promoted were very expensive as in the case of an inhaler for asthma costing £22 as compared to the NHS blue one at £1.96.

      The entertainer was told not to invoice the pharmaceutical companies but to invoice a small lighting company.

      The pharmaceutical companies were providing so many luxury trips that the lighting company originally doing the invoicing to the pharm company, as lighting, then paying the entertainers, could not cope. So this entertainer was actually put on the books of the pharmaceutical company and was provided with a supply number for the invoices.

      This stopped about six years ago and he knows that now the way the companies continue to entertain the doctors, is by employing professional entertainers with some kind of medical or health qualification such as therapist.

      So a person with a background in entertainment now ostensibly employed as a therapist/speaker but who, if you attend a therapy weekend will be found doing stand up or some other entertainment for far longer than the actual 10 or 15 minute listed therapy talk. The fees are substantial for such entertainers with medical qualifications.

      My source, has the same fear that so many in the medical profession and businesses have, that if he is identified, his current livelihood could be affected. He would be willing to be interviewed and produce evidence, if his identity could remain anonymous.

    IV.  Patient Groups should be told to display how much they receive from the pharmaceutical industry on their literature. A "health warning" should be mandatory to go on all literature from such groups as Depression Alliance who receive support from the industry.

    V.  The CME and other educational courses should be removed from the influence of the industry.

    VI.  The Government should develop guidelines for ethical management of professional organisations and the Royal colleges.

    VII.  The practice of promoting drugs in GP practices could be stopped.

    VIII.  The government will have to find ways of halting the influence of the industry. It should be illegal for politicians to accept free food, entertainment or money from the pharmaceutical industry, either for themselves, for meetings they organise or for party funds. Tony Blair had breakfast with Paul Drayson (now a life peer). His company, Powderject, made an estimated £20 million. The Government purchased a smallpox vaccine from them. Drayson apparently gave a second £50,000 donation to the Labour party while the Government was deciding who should be handed the contract.

    Link to an article :,9061,1249440,00.html

    IX.  The National Suicide Prevention Strategy and the National Service Framework have failed in not mentioning that depression and suicide may result from ADRs. The Government should establish how and why these omissions occurred.

      The close partnership with the ABPI and the NHS will result in greater than ever drug promotion. The Government should make sure that the education of medical students, nurses and health professionals balances the immense influence of the industry in every sphere of their lives.

      Chairs at universities in Drug adverse effects and Toxicology should give an opportunity to medical and other students to specialise. Education which currently rarely included even and exam in pharmacology and therapeutics, let alone toxicology and ADRs, should include the subject in all curricula.


      Professional Education

      A very worrying fact is that few medical schools include any exam specifically in how drugs work, or how to prevent, recognise or treat ADRs.

      Southampton University has just dispensed with their 12 days of pharmacology and therapeutics and replaced this with alternative medicine. According to Professor Saad Shakir of the DSRU.

      The GMC produce guidelines on medical education "Tomorrows Doctors" and only added a reference for the need to include ADRs when I had pointed out their omission. They thanked me for drawing their attention to this. Dr John Halliday drew my attention to this and told me of the concerns of others like himself who were teaching pharmacology in universities.

      Patient Education is often biased as it stems from support groups and disease campaigns funded by the industry, as happens at the Royal Institution.

      The refusal of the Dean of UCL to display a flyer for a conference offering free places to medical students to hear leading experts in ADRs in 2001 was a shocking reality. He did not want to jeopardise his funding, he was reported to have told the member of the students union who asked permission for the flyer to be displayed.

Recommendation for Action by the Government

      Government funding for medical education should be increased to reduce reliance on the pharmaceutical industry. All the universities where no specific pharmacology or ADR education takes place should be warned not to let their major source of funding be an industry that influences the standard of education.


      The regulatory agency (MHRA) is also promoting the pharmaceutical industry and therefore cannot be viewed by the public as truly working in the interests of the patients.

      It is known that drug licences are rushed through and that pharmaceutical companies may be selective in providing results of favourable clinical trials while withholding unfavourable results. Clinical trials do not currently have to include a cross section of population using varied age, gender and ethnic origin. Withdrawal period is excluded from clinical trials and reviews of patients, following cessation of drug, are not mandatory.

Recommendation for Action by the Government

      Efficacy should be assessed on the basis of comparison with similar drugs using equivalent dosage and for the age group that may be prescribed the drug.

      Results of all the clinical trials should be reviewed before licensing. No trial results should be hidden and it should be a criminal offence if trial data is hidden or altered.

      ADR statistics should be centralised and information from such as the Royal College of Anaesthetists should be pooled centrally on an independent data base. Not, as now, retained solely for their own purposes.

      The collating and analysing of ADR data should be funded by the government and should include data from medical records of patients who suffer sudden unexpected death due to organ failure, accident or suspected suicide. This data could be analysed and interesting statistics could emerge without recourse to expensive toxicity tests which fail to show all the drug deposits that may be in the tissues or otherwise dispersed from the blood soon after death.

      The benefit to the Government would be to win back the respect of the public and the savings for the NHS would more than cover the cost in the long run.


      Not applicable to APRIL

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