Paul Wood = PW in Ariel font
Peter Mansfield = PRM in Times New Roman font
Dear Paul,
Thank you for your response to my questions. I hope you find my reply helpful for advancing issues that are important both for the staff members and shareholders of AstraZeneca whose interests you represent and for the health professionals and members of the public that I represent.
PW: No
PRM: Please see my reply under 2. below:
PW: The company experts have told me very clearly that the claims in the ad are supported by the evidence and reading the evidence in the other enclosed document I find it convincing. The ad has been judged acceptable (twice) under a well established and respected code of conduct involving independent adjudicators. When there is a difference of opinion codes of practice, backed up by regulations, are the best way there is of deciding (based on all the available evidence) on the acceptability of advertising and which opinion has greatest merit.
PRM: Please read our explanation of why the document produced by your company’s "Nexium experts" is not convincing and reconsider your position.
PRM Q1a: Do you agree that there are any problems with the Nexium advertisement?
PRM Q1b: If not, why not?
PRM Q1c: If yes, what is being done about it?
PRM Q2a: If you are not able to detect that there are problems with this advertisement, despite our careful explanations, why should anyone trust any information from your company?
PRM Q2b: Are you able to provide us with a copy of all the documents required to enable us to evaluate the judgement by the “independent adjudicators”?
PRM Q2c: Are these “independent adjudicators” and the organisations they represent independent of any financial relationships with the pharmaceutical industry?
PRM Q2C: Do these “independent adjudicators” have adequate expertise?
PW: Not applicable
PRM: The first step to quality improvement is accepting that improvement is possible.
PW: We have responded to your requests and questions, just as we would for any health care professional. Your criticisms of the claims made for Nexium are not supported by the available evidence. In these circumstances I can’t see any benefit in supporting the ‘Sandoz approach’ of long haul flights to discuss the ads. Equally we have not dismissed your actions out of hand and declined to enter into any dialogue, an approach which it seems other companies have adopted in the past. However, having provided the comprehensive information in the companion document it is difficult to see benefit from extending further the dialogue on Nexium claims in the future.
PRM: As indicated in our reply to your anonymous experts we agree that there is no benefit from further dialogue if your company is not willing to make any improvements. If your company is willing to make improvements then we would be very happy to assist.
PRM Q4a: Is you company willing to make improvements to the promotion of Nexium?
PRM Q4b: If yes, what improvements?
PRM Q4c: If no, why not?
PRM Q4d: Why did your company take over 6 months to respond to our prototype and why has your company not yet commented on our Feedback about Nexium issue, in particular why has your company not commented on the suggestion that half doses of Somac 40mg or Nexium 40mg be used rather Nexium 20mg?
You’ve asked several more questions.
5. Do I agree with your assessment of the link between company / product performance and promotional standards?
PW: Most definitely not. Had the company or product performance been poor you could have argued that this brought pressure to lower standards. In fact neither is true. AstraZeneca standards are based on industry standards (which are closely aligned with the WHO ethical criteria globally and regulations/codes nationally) and we try to apply them conscientiously and consistently. Whether or not a new drug is better than an older one must be judged on the evidence and the evidence for Nexium superiority claims is outlined in the separate technical/medical response.
PRM Q5a: Do you agree that high levels of use of a drug reward manufacturers for the type of promotion that they used to achieve the high level of use?
PRM Q5b: Is misleading promotion allowed under any of the relevant codes and regulations?
6. Do I agree with Garai?
PW: Thank you for drawing my attention to this speech - it is a worthwhile and interesting read. However the article is 40 years old and the pharmaceutical industry and healthcare generally has changed hugely over that time period. So while some (but not all) of the thinking and quotes might still be relevant today, such big changes in drug development and marketing have taken place that conclusions based on the situation four decades ago inevitably need major reassessment. In today’s world it makes no economic sense to invest the huge amount of money now necessary to develop a new drug unless we can generate the evidence to convince prescribers, patients and payers that the new agent has worthwhile advantages. The conclusion you pull out of the paper therefore needs updating because I hope and believe that companies’ communications are now much more centred on evidence than on ‘doing what it takes’ and health professionals decision making is more discerning. Neither is perfect in every case but any creed on which improvement is sought must be based on the situation in 2003.
PRM Q6a: Do you believe that there have been any significant changes in human nature or in business fundamentals since Garai’s speech?
PRM Q6b: If so, please list them and provide evidence.
PRM Q6c: Do you agree that drug sales depend on whether or not prescribers, patients and payers have been convinced that there is good evidence of worthwhile advantages?
PRM Q6d: Do you agree that it is possible for drug companies to convince prescribers, patients and payers that there is good evidence of worthwhile advantages even when there is not?
PRM Q6e: Do you agree that drug companies that are successful at doing that will make more money at least in the short term?
7. What do I think about ‘the hypotheses’?
PW: These are not hypotheses with recognisable metrics and you must be using the concept of ‘hypothesis testing’ in a lay sense rather than the normal scientific sense. In effect I think you are putting forward opinions and seeking evidence to support them and I’m happy to state my views on the statements.
PRM: I am interested in supportive evidence but disconfirming evidence that would enable further development of the hypotheses would be even more interesting.
1) Harm from misleading drug promotion will be reduced by developing healthy skepticism amongst health professionals and the general public.
PW: To verify this you would first have to define and quantify the base lines –‘misleading drug promotion’ and the ‘harm’ that it causes (care is needed not to mistake opinions for evidence). I’ve done quite a lot of thinking around quantifying performance in promotional standards and it’s a big challenge to identify meaningful metrics and then to measure change.
PRM: I agree.
PRM Q7 1)a: Do you agree that increasing levels of healthy skepticism could lead to improvements in drug use without any change in drug promotion?
PRM Q7 1)b: Are you willing and able to share your ideas about performance measures for drug promotion with us?
PW: A ‘healthy scepticism’ must be a good thing for everyone to have with respect to information we receive from all information providers. A healthy scepticism is needed towards the information provided by governments, companies, doctors, pharmacists, patient associations and even, dare I suggest, ‘Healthy Skepticism’ itself! Health professionals and competitor companies, who demonstrate their healthy scepticism by challenging ads though code of practice procedures, help to maintain good standards.
PRM: I agree except I do not agree that current standards are acceptable, let alone good, so I would prefer to see improvement rather than maintenance.
2) Drug companies will adapt to produce whatever the market rewards.
PW:Drug companies do try to respond to their customers and do try to make their marketing effective. I think the relationship between companies and doctors has become more ‘professional’ over the years and can develop further in this direction and there are already many examples of really excellent educational and promotional items and activities. In fact the good stuff far far outweighs any ‘debatable’ material. Of course one thing that the ‘market rewards’(doctors and patients) is good efficacy and tolerability – the ‘in practice’ fulfilment of the promises made by advertising.
PRM: I am very pleased that you acknowledge that there is room for improvement (“can develop further”).
PRM Q7 2)a: Do you agree with Al Ries and Jack Trout (authors of Positioning. New York: McGraw Hill 2001) that market rewards are based on perceptions rather than realities?
PRM Q7 2)b: Do you agree that perceptions about efficacy and tolerability are not always accurate?
PRM Q7 2)c: Do you agree that perceptions can be influenced by promotion?
PRM Q7 2)d: Do you think there are any ways that the promotion of Nexium “can develop further”?
PRM Q7 2)e: Do you agree that if “the good stuff far far outweighs any ‘debatable’ material” then we would expect that those doctors who use and trust information from drug companies more would be better prescribers than those who use and trust such information less?
PRM Q7 2)f: All the 13 studies that we are aware of that have addressed this issue suggest the opposite. (See: www.healthyskepticism.org/risk.htm ) Do you know of any studies that have found that doctors who use and trust information from drug companies more are be better prescribers?
3) Self regulatory systems will defend current standards rather than drive improvements.
PW: I disagree. The self-regulatory system I know best is the ABPI code in the UK. This covers much wider ground than the legislation and is regularly updated. Where there is a need for change, or to cover new areas, the code is updated and implemented. Amongst many recent changes are updated requirements on sponsoring doctors to overseas meetings and a new section on the Internet. It is an extremely effective way of driving change. Equally professional codes of ethics can be effective driving change from ‘the other side’ and it is important that doctors and industry associations work together on defining and regularly updating what is ‘acceptable’ practice.
PRM Q7 3)a: Can you justify industry codes in countries other than the UK that set lower standards than are set by the ABPI Code?
PW: I do not agree that your approach is better at improving standards and cannot accept your claim to the high ground of ‘in contrast ..improving standards for the benefit of health professionals and the public’. Also I find it rather disturbing that you will judge the helpfulness of the self-regulatory system on whether or not it agrees with your opinion. I have said it before but I believe the AdWatch approach, whereby a critical appraisal of an ad is published and then a highly selected audience is asked for feedback, is considerably less helpful and reliable than self-regulatory codes. Your ‘complaints are a gift’ theme is a good one but of course some gifts are more ‘useful’ than others.
PRM: The AdWatch team are able to evaluate advertisements according to higher standards than are currently accepted in the industry so as to advance the interests of health professionals and the public. Self regulatory code systems are limited to evaluating advertising according to the current agreed Code.
AdWatch participants are a volunteer sample. They are self selected in response to open invitations for example in reports published in the official journals of the Australian, Canadian and British Medical Associations. AdWatch participants are not selected by the AdWatch team. The distinction between a volunteer sample and a selected sample is important.
We accept that AdWatch participants are not a representative sample of all health professionals and all members of the public. However they do represent a market segment that is growing and becoming more influential. To the extent that this healthy skeptic’s market segment develops (be it because of or despite our efforts) your company’s future will depend on learning how to respond to us.
We will judge the helpfulness of self-regulatory systems on the basis of the improvements that they achieve or their ability to explain to us why improvements are not required.
We will form our final conclusions about advertisements only after careful evaluation, on its merits, of a wide range of input, including input from the company responsible and the self regulatory system. The AdWatch approach is entirely consistent with the self regulatory system. The main difference is that we have an open process for deciding about advertisements before writing a complaint.
PRM Q8a: Would you prefer that we complain to self regulatory systems with or without having an open process first?
PW: I’m confused that you say I haven’t seen any feedback - I read the feedback on your website; but understand there’s more to come.
PRM: At that time you had seen the feedback on the AdWatch prototype but had not seen any feedback on the final AdWatch on Nexium.
9. How do I feel about the AstraZeneca defence that the Nexium claims have been ruled not to be in breach of a code.
PW: Reassured
PRM: You have changed my question. My question was:
PRM Q9: How do you think health professionals and members of the public should feel about your company's use of this type of argument [appeals to the authority of “experts” in a self regulatory system without the evidence or the arguments]?
10. Do we have any other arguments?
PW: It seems you do not accept the previous code judgements and, as stated above, we are providing a full evidence based response to your criticisms.
PRM: We have not yet seen the previous code judgements so we have not evaluated them. I have requested copies of these judgements in Q2a. We look forward to receiving them from you.
11. Are health care professionals who have concerns about the ads incompetent to form their own opinions?
PW: Of course not! There will always be different opinions and people will form their opinions based on various influences. However bias is unavoidable because those who are inclined to have negative feelings towards company ads will tend to visit your website and join your organisation. Those who have read your critical analysis of the Nexium ad claims will tend to agree.
PRM: Bias is normal. AdWatch participants have demonstrated a wide range of views but most are biased towards the interests of patients. Few have any financial or other competing interests that would bias their evaluation of your companies advertising. By contrast, there are several mechanisms including financial competing interests and groupthink that will systematically bias evaluations of drugs and drug promotion by staff of the company responsible. In conclusion: AdWatch participants will evaluate advertisements and our work with a range of biases but on average will be less biased than staff of drug companies.
PRM Q11a: Do you agree that AdWatch participants will be less biased than staff of drug companies?
PRM Q11b: If not, why not?
12. Are their concerns justified?
PW: That can be judged by a rational, scientific analysis of the claims made and the evidence available to support them.
PRM Q12a: Do you believe that our analysis is irrational?
PRM Q12b: Do you believe that our analysis is unscientific?
PW: Code of practice bodies are set up to do that very job. We have properly constituted self-regulatory and regulatory mechanisms to handle promotional standards concerns – we should all do what we can to support and continually improve them. Drawing a parallel, although we all sometimes disagree with some jury or judge’s decision, denying the authority of the law is a negative influence on our society.
PRM: We have worked on improvements to the Medicines Australia Code via suggestions to the Australian Consumer and Competition Corporation and recently via correspondence with Medicines Australia that we will publish later.
PRM Q 12c. Do you believe that health professionals and the public should accept the conclusions of self regulatory systems even when the all the information available (including the information provided by the company responsible) does not support those conclusions?
PW: In putting forward alternative views to those you have outlined I realise that my comments could suggest complacency. Let me assure you that this is not the case and I fully support continuous improvement in promotional standards. However we must probably agree to disagree on the best methods for achieving this. Maybe one day we’ll meet and debate the issues further.
Q12d. Are you now able to identify any areas for improvement in your company’s promotion of Nexium?
I have one additional question.
Q13. What are your responsibilities within AstraZeneca?
yours sincerely,
Dr Peter R Mansfield
Director, Healthy Skepticism
Editor, AdWatch