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Healthy Skepticism International News

October 2002

APPENDICES

APPENDIX A INFORMATION LETTER MaLAM Subscriber Address Address Address Dear MaLAM Subscriber, Re: Pharmaceutical representatives and gifts Malam is seeking to further investigate the impact and influence of pharmaceutical promotion in medical practice, with particular emphasis on pharmaceutical representative visits and gifts. Focus groups will be organised across the adelaide metropolitan area in the next few months for malam subscribers to discuss these important and controversial issues that are of relevance to all doctors. Participants will be encouraged to discuss their personal experiences of pharmaceutical representatives and gifts, and offer their thoughts and opinions on these issues. Differences of opinion and open debate will be encouraged. The focus groups will provide further valuable insights into the influence of pharmaceutical promotion in the medical profession, and how doctors deal with such promotion. Peter Mansfield and Lynda Caudle, an Honours Psychology student at Adelaide University, will be conducting the research. Information provided in the study will be kept confidential and anonymous, and any audiotapes destroyed after completion of the project. Further inquiries regarding the study may be directed to Peter at MaLAM or Lynda on 8276 5152. The Psychology Department Ethics Subcommittee has approved the study and the convenor, Dr Peter Delin, may be contacted on 8303 5007. MaLAM subscribers who participate in these focus groups will have the opportunity to meet with Peter and other MaLAM subscribers in an informal and friendly setting with light refreshments. We will arrange times and venues to suit participants. If you are interested in participating, please indicate your interest below and fax this letter back to MaLAM on 8374 2245. We look forward to seeing you at one of the focus groups! We will also be sending out a short questionnaire soon to enable you to provide written comments (whether or not you attend a focus group). Yours sincerely Dr Peter Mansfield Ms Lynda Caudle Director, MaLAM Honours Psychology, Adelaide University Please indicate if you are interested in attending a focus group: Yes No Contact telephone number(s) Contact fax number Please fax this letter back to MaLAM on 8374 2245 APPENDIX B CONSENT FORM PHARMACEUTICAL REPRESENTATIVE VISITS AND GIFTS STUDY CONSENT FORM Name of Researchers Ms Lynda Caudle, Psychology Honours Student, Adelaide University Dr Peter Mansfield, Director of MaLAM Dr Peter Mansfield, Director of MaLAM Ms Melissa Raven, Department of Public Health, Flinders University Assoc Prof Martha Auguostinos, Psychology Dept, Adelaide University Name of Supervisors 1. I consent to participate in the above study. The nature of the study, including questionnaires or procedures, has been explained to me, and is summarised in the introductory letter I have received. 2. I authorise the responsible investigators or the persons named above to use these questionnaires or procedures with me. 3. I understand that: a. I am free to withdraw from the project at any time. b. The project is for the purpose of research or teaching, and not for treatment. c. The confidentiality of the information I provide with be safeguarded. d. There are no known adverse effects of these questionnaires or procedures. Signed: Date: APPENDIX C FOCUS GROUP INFORMATION SHEET THE PHARMACEUTICAL REPRESENTATIVE, GIFTS AND SAMPLES FOCUS GROUP In this focus group we will be discussing pharmaceutical promotion, with particular emphasis on the pharmaceutical representative, gifts and samples. For the purpose of the focus group ‘gifts’ will include anything received as a personal gift from pharmaceutical companies. Examples of ‘gifts’ include the following: Pens, notepads and other stationary; Medical equipment and textbooks; Lunches; Dinners accompanying educational seminars; Travel expenses and accommodation at conferences, symposiums etc; Entertainment; And any other personal ‘gift’ received. Participants are encouraged to talk freely about their experience and opinion of pharmaceutical representatives, gifts and samples. We hope you will enjoy the experience of participating in this focus group and thank you for your involvement. APPENDIX D FOCUS GROUP: QUESTIONS AND ISSUE STATEMENTS FOCUS GROUP QUESTIONS A Pharmaceutical Representatives 1 Do you see pharmaceutical representatives, and if so, how often do you see them? 2 What are your reasons for seeing pharmaceutical representatives? 3 What do you see as the advantages of seeing pharmaceutical representatives? 4 What do you envisage as the disadvantages of seeing pharmaceutical representatives? 5 How would you describe the relationship you have with the pharmaceutical representatives you see? 6 What do you think of the information pharmaceutical representatives present to you? a. Do you think the information is accurate? b. Do you think the information is complete? c. Do you think pharmaceutical representatives present an unbiased view of their product in the marketplace? 7 Do you think it is unethical for doctors to see pharmaceutical representatives? or Do you think seeing pharmaceutical representatives creates any ethical problems for doctors? Gifts 8 Have you received a ‘gift’ from a pharmaceutical representative or pharmaceutical company, and if so, what ‘gifts’ have you received? 9 Are pharmaceutical company-sponsored lunches, dinners, samples, and other ‘gifts’ and ‘hospitality’ harmless? 10 Do these ‘gifts’ constitute a bribe or conflict of interest? 11 Are these ‘gifts’ given freely with no ulterior motive? 12 What do pharmaceutical companies expect in return for these ‘gifts’? 13 Do you feel obligated to reciprocate in response to the ‘gift’ giving? 14 Is it unethical for doctors to accept ‘gifts’? Samples 15 Should pharmaceutical companies supply drug samples to doctors? 16 Should doctors and office staff use drug samples given by pharmaceutical companies? 17 Does the use of drug samples for patients constitute an ethical dilemma in medical practice? Regulation of Promotion 18 Are you aware of the AMA guidelines on pharmaceutical promotion? 19 Are the AMA guidelines adequate in your opinion? 20 In your opinion, is the current system of self-regulation of the pharmaceutical industry by the APMA adequate? 21 What changes, if any, would you like to see in the status quo of the provider-doctor and doctor-consumer relationships? FOCUS GROUP QUESTIONS B 1 Do you think seeing pharmaceutical representatives creates ethical dilemmas for doctors? NO Justification YES Reasons Issues: Critical appraisal ability Ability to recognise and counteract promotional influence 2 Do you think receiving ‘gifts’ creates an ethical dilemma for doctors? NO Justification YES Reasons SOMETIMES – Hierarchy of moral weight Issues: Rational prescribing Persuasion of doctor Cost to health care system 3 Do you think receiving samples is ethically unsound? NO Justification YES Reasons SOMETIMES – Hierarchy of moral weight 4 Do you think pharmaceutical promotion in Australia is currently adequately regulated? NO Reasons, concerns and suggestions YES Justification DON’T KNOW Issues: AMA position Codes of conduct – AMA and APMA Breaches of codes and reprisals Number of incidents of reported breaches TGA – Fully funded by the industry – government incentive scheme FOCUS GROUP ISSUES STATEMENTS “Past empirical studies have shown …” “It has been empirically proven that …” “Some doctors believe …” “Some people think …” “It has been stated that …” Pharmaceutical Representatives 1 Pharmaceutical Representatives present unbalanced, inaccurate and incomplete information favouring their own pharmaceutical product. 2 Pharmaceutical representatives utilise inherent social influence techniques such as reciprocation, consistency, social validation, liking, authority and scarcity (Cialdini, 2000). 3 The objective of pharmaceutical representative visits is to change doctors prescribing habits. 4 Doctors change prescribing habits in response to pharmaceutical representative visits and gifts. 5 Pharmaceutical representative visits is an effective and successful promotional technique, otherwise why would pharmaceutical companies continue to use such an expensive method of promotion? Gifts 6 Reciprocity is a powerful and socially inherent, behavioural influence technique, well utilised by the pharmaceutical representatives in the carefully cultivated context of the friendly, amiable doctor-pharmaceutical representative relationship. 7 All ‘gifts’, from seemingly inconsequential to very substantial monetary value, engender an effective reciprocity effect. Samples 8 Samples are another form of gift giving requiring reciprocity. 9 Samples are primarily promotional, constituting a form of DTC advertising, which has prompted recommendations for pharmaceutical companies to eliminate the promotional packaging and include enough of the drug in the sample to allow administration of a complete course of therapy (ie antibiotics). APPENDIX E TRANSCRIPT NOTATION KEY TO SYMBOLS Underlining indicates words or parts of words which are stressed by the speaker. : make the prolongation of the sound immediately before (then:n); more colons show longer prolongation (Ah:::) ¯ Marked rises and falls in intonation ? A questioning intonation (there is no necessary correspondence with utterances participants treat as questions). . A completing intonation (eg line 2) – (not necessarily a grammatical full stop). , Eg line 6 marks a continuing intonation (not necessarily a grammatical comma). - Eg Thanks- Tha:nksgiving) marks a noticeable and abrupt termination of a word of sound. [ ] Eg lines 2,3,8,9,10 and 11 mark the onset and completion of overlapping talk. = One turn runs into another with no interval (Eg lines 1,2,9 and 11). (Number) Eg (0.5) the duration of a pause in tenths of a second; where there is just a (.) in the bracket – pause is hearable but too short to measure. °um° Talk that is quieter than the surrounding talk WHERE Talk that is louder than the surrounding talk is capitalised. ® Arrows in the margin – pick out lines of transcript for discussion in the text; do not mark features of delivery. ( ) Transcriber doubtful of a word or phrase – placed in parentheses; if no guess is plausible these parentheses are left empty. (( )) Clarificatory comment is placed in double parentheses: ((laughs)) or ((stands up)). […]. Where material from tape has been omitted for reasons of brevity – indicated by […]. (DE-JF/C2/S1:4) Code at end of transcription – Extract from transcript produced by Derek Edwards and Jon Fong (DE-JF). The talk is from the second couple in the sample (C2) in their first session (S1) and it appears on the fourth page of the transcript) APPENDIX F MaLAM The Medical Lobby for Appropriate Marketing (MaLAM) was established in 1983 by Dr Peter Mansfield, and became an international non-profit organisation of health professional subscribers dedicated to MaLAM’s aims. MaLAM’s aims were: (a) To defend appropriate compassionate scientific medical care, health professionals and the public from marketing practices which may be detrimental to health; (b) To engage in dialogue with bodies involved in health-related marketing. (c) To provide a balance of information and practical opportunities for action, which assist health professionals to act for the benefit of the public; (d) To encourage bodies involved in health-related marketing to provide reliable information to assist appropriate therapy; (e) To support appropriate compassionate scientific medical care; (f) To provide a Medical Lobby for Appropriate Marketing where: ‘Appropriate Marketing’ refers to “health-related marketing with provision of appropriate information to assist health professionals to provide appropriate compassionate scientific medical care” ‘Medical Lobby’ refers to “an organisation which conveys the concerns of health professionals in ways that encourage ‘Appropriate Marketing’”. MaLAM subscriber’s received copies of letters, written by MaLAM and addressed to pharmaceutical manufacturers on a monthly basis. The letters stated questionable promotional claims, provided a summary of scientific literature for comparison by the manufacturer and requested the manufacturer’s evidence in support of the claim. MaLAM subscribers agreeing with the concerns raised in each letter, signed an accompanying support letter, and sent the letters to the manufacturers concerned. In 2001 MaLAM changed its name to Healthy Skepticism (www.healthyskepticism.org). Its mandate essentially remains the same, but it is now operationally different, and has an increased emphasis on education and enhancement of healthy scepticism and critical appraisal skills in health professionals. APPENDIX G AUSTRALIAN MEDICAL ASSOCIATION POSITION STATEMENT: CODE OF ETHICS

 

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909