From: Woods, Paul B [mailto:Paul.Woods@astrazeneca.com]
Sent: Tuesday, 2 December 2003 7:59 PM
To: Peter R Mansfield (E-mail)
Subject: Response to your e-mail concerning Nexium advertising and
Promotional Standards
Peter,
There are 2 distinct topics of debate in our correspondence. The first
concerns your and my views on 'process' and the second is your concern about
the claims made for Nexium. In order to best cover these two topics I am
attaching separate documents:
A) My answers to your 'process' questions. While we may disagree on the
'best' way to encourage and support good promotional standards, and it has
been good to have the debate, I hope that at the very least I have been able
to convince you that we take promotional standards seriously and that we (I,
AstraZeneca and industry associations) are active in taking forward this
agenda.
B) Clearly you are asking for more detail than AstraZeneca has provided so
far. I attach a detailed evidence based response to the medical challenges
you make in the AdWatch article, prepared by the senior Nexium experts from
our Gastrointestinal headquarters in Mölndal, Sweden. On reading this
document I hope you will find it convincing and will consider changes to
your original assessment to be necessary. We will be happy to provide hard
copies of the references should you wish to receive them. The document could
be included in your website to balance your criticisms. I trust that the
information will bring this matter to a conclusion.
Further to your earlier comment I am sending a copy of this reply and the
earlier correspondence to our Chief Executive Sir Tom McKillop.
regards
Paul
Attachment A: Paul Woods' personal response to Peter Mansfield's questions
around 'process'
<<Comments PW Healthy Scepticism.doc>>
Attachment B: Comments on the criticisms of Nexium advertising
<<Nexium Claims healthy skepticism.doc>>
You ask me to respond specifically to your 3 questions:
A: No
A: 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.
A: Not applicable
A: 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.
You’ve asked several more questions.
Q: Do I agree with your assessment of the link between company / product performance and promotional standards?
A: 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.
Q: Do I agree with Garai?
A: 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.
Q: What do I think about ‘the hypotheses’?
A: 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.
1) Harm from misleading drug promotion will be reduced by developing healthy
skepticism amongst health professionals and the general public.
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. 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.
2) Drug companies will adapt to produce whatever the market rewards.
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..
3) Self regulatory systems will defend current standards rather than drive improvements.
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.
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.
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.
Q: How do I feel about the AstraZeneca defence that the Nexium claims have been ruled not to be in breach of a code.
A: Reassured
A: 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.
Q: Are HCPs who have concerns about the ads incompetent to form their own opinions?
A: 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.
A: That can be judged by a rational, scientific analysis of the claims made and the evidence available to support them. 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.
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.