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Healthy Skepticism International News

June 2004

Correspondence about promotion of Cialis at www.erectionproblems.com.au

Abstract:

This month’s issue features correspondence between Peter Mansfield and Medicines Australia about the http://www.erectionproblems.com.au website, and possible illegal promotion of Cialis.
(Peter’s questions in blue font; responses in black)

From: Peter R Mansfield [mailto:peter@healthyskepticism.org]
Sent: Saturday, 20 March 2004 3:19 PM
To: Kieran Schneemann
Subject: Cialis website Code of Conduct complaint

Kieran,

I could not find anywhere in your Medicines Australia Code of Conduct instructions re where to address complaints so I would appreciate it if you forward the following to the appropriate people. However this complaint raises several serious issues so I would appreciate it if you and your board gave it urgent attention.

The homepage of the http://www.erectionproblems.com.au website states that:

“This site is provided by Eli Lilly Australia, the suppliers of CialisTM. The internet offers you a discreet way to learn more about erectile dysfunction, and we hope this site helps you feel more comfortable and confident to talk with your healthcare professional or your partner.”

This website can be expected to have the effect of promoting the sales of Cialis by:
a) increasing the size of the erectile dysfunction market and/or
b) by increasing the market share for Cialis.

a) The website can be expected to achieve increase market size by increasing the numbers of patients who mention erectile dysfunction to their doctors. This may or may not be a good thing. The point is simply that sales will increase sales so the website has a promotional function ie. “encouraging the usage of that product”.

b) The website can be expected to increase market share for Cialis above what it would have been by increasing the numbers of patients who are familiar with the Cialis. This will make them more likely to request or mention it by name to their doctor or to accept it if their doctor mentions it first. Doctors like to please patients and may believe that there is no major medical difference between the drugs in this class. Consequently patients’ requests, reminders or acceptance will be enough to tip the balance on at least some occasions so as to make doctors more likely than otherwise to prescribe Cialis rather than an alternative therapy.

In conclusion, whilst the website may or may not be educational, it is promotional. Further evidence of the promotional nature of the website is the use of images very similar to those used to promote the drug to doctors.

I note that the definition of promotion in your Code of Conduct glossary is significantly narrower than dictionary definitions and thus creates a potentially large loophole. Depending on interpretation it appears that a “statement” will only be regarded as promotion by under the Code if it “conveys the positive attributes of a product which extend beyond a simple non-qualitative or quantitative description of the therapeutic category or approved indication”. This “includes statements concerning efficacy, rate of adverse reactions or other cautionary aspects of the product and comparative information.” This loophole should be removed immediately by replacing the definition of promotion with a standard dictionary definition such as: “the act of furthering the growth or development of something; especially :the furtherance of the acceptance and sale of merchandise through advertising, publicity, or discounting”. (Merriam Webster)

Lilly may believe that their website was acceptable because of that loophole. However their website homepage includes the statement that “With the development of new medical treatments for ED, and with better understanding of some of the medical causes of ED, the focus has shifted from the therapist’s office to the medical office.” This statement is clearly a claim of superiority (be it due to greater efficacy or lesser adverse effects) for “new medical treatments” compared to the psychological therapies that are mentioned in the previous sentence on the website. This statement clearly goes beyond a description of the therapeutic category or approved indication. Many people will know or assume that Cialis is one of the “new medical treatments”. This statement may or may not be justified but the point is that it is promotional.

Consequently the website is in breach of the Medicines Australia Code of Conduct especially sections 9.4 and 9.5 and also section 9.8 both because it is such an open breach of the Code and because it is an open breach of the principles the of ethical pharmaceutical industry ie limiting promotion of prescription only drugs to health professionals.

The Cialis website may also be illegal but I do not have the legal expertise to be sure of that. Consequently I would appreciate it if Medicines Australia would provide a legal opinion as to whether or not the use by drug companies or websites that name prescription drugs is or is not currently illegal in Australia.

The Cialis website may be in breach of other sections of your Code of Conduct but I do not have time to check that today. Consequently, I would appreciate it if you would delegate the task of performing a through investigation to a team with appropriate expertise and resources.

regards,

Dr Peter R Mansfield

From: “Kieran Schneemann”
To: “Peter R Mansfield”
Sent: Saturday, March 20, 2004 3:11 PM
Subject: RE: Cialis website Code of Conduct complaint

Thank you Peter.

I will refer your email onto Heather Jones, who is the Secretary of the Code of Conduct Committee, first thing on Monday.

I am very concerned that it is not clear where complaints are to be referred to. I understood that it was clear and in addition there were contact numbers available where assistance can be provided if there is a need or requirement. I will ensure this is followed up next week and advice provided to you for your reference and information.

You make mention of the Board in your email to me. I feel I should confirm and inform you that the Board do not have any involvement with the Code of Conduct Committee. The Code of Conduct Committee receives complaints and formally meets to consider them.

The Committee is established under strict rules which are detailed in the provisions of the Code and as I expect you would know, the Medicines Australia Secretariat provides secretariat support to the Committee.

I will ask Heather to be in touch with you regarding your email message.

Kind regards

Kieran

From: Peter R Mansfield [mailto:peter@healthyskepticism.org]
Sent: Saturday, 20 March 2004 5:03 PM
To: Kieran Schneemann
Subject: Re: Cialis website Code of Conduct complaint

Kieran,

Thank you for your rapid and helpful response.

There are some issues raised in my complaint that I expect could only be resolved at board level.

The Code booklet does indeed provide a phone number for requesting assistance. I had assumed, perhaps incorrectly, that such a number would only be answered 9-5 on weekdays and I was keen to move on this immediately I was alerted to the problem.

I have re checked the Code of Conduct booklet and found that there is a postal address, and phone and fax numbers for Medicines Australia on the back cover but it is not stated if they are they are to be used for sending complaints. They are in small type and I had not seen them before. There is no email address. I have several reasons for preferring for all communication to be via email.

The same applies to the Code of Conduct pages on your website where contact information is given on the bottom of the page but it is not stated if it is to be used for sending complaints.

kind regards,

Peter

From: ‘Heather Jones’ .(JavaScript must be enabled to view this email address)
Manager Marketing Strategies
Medicines Australia
To:
Sent: Monday, March 22, 2004 11:56 AM
Subject: Response from Medicines Australia re complaint

Dear Dr Mansfield

Mr Kieran Schneemann has forwarded your email to me in my capacity as Secretary for the Code of Conduct Committee. Thank you for raising the question on how to lodge a complaint under the Code of Conduct. While there is information in the Preface to the Code on page 6 and in Section 11 and Appendix 1 in the Code of Conduct document on the website and booklet, I will undertake to have an additional section included on the Medicines Australia website on how to lodge a complaint within the next 48 hours.

As stated in the Code, Medicines Australia will assist an external complainant in understanding the Code process and in lodging a complaint, including identifying relevant sections of the Code if so required. All calls and emails to Medicines Australia will be answered promptly.

I have forwarded your concerns in relation to the Eli Lilly website www.erectionproblems.com.au to the company as a formal complaint. The complaint will be heard at the 19 April Code of Conduct Committee meeting. You will be advised of the outcome and a copy of the full minutes of the discussion relating to your complaint following finalisation of the minutes. Please find attached a formal letter of acknowledgement of the complaint. I will send the final minutes to you by email, or can send them in hard copy by post if you prefer.

In relation to your comments regarding the definition of promotion contained in the Code, this was accepted by the Australian Competition and Consumer Commission when it recently granted authorisation of the Code. It is also accepted by the Therapeutic Goods Administration, which was consulted during the recent amendments of the Code leading up to edition 14. Further, the definition of ‘promotion’ in the Code is intended to be consistent with the definition of an ‘advertisement’ in the Therapeutic Goods Act 1989, which is as follows:

‘advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.’

Notwithstanding this, we will refer your strong recommendation that the definition may provide a loophole by too narrowly defining promotion to the review of the Code of Conduct which will be commencing in the next few months.

May I please clarify one aspect of your request for a legal opinion in relation to company-sponsored websites? Is the question about the use of a prescription medicine name as part of the website address? Your e-mail may include a typo where ‘the use by companies of websites that name prescription drugs’ became ‘the use by companies or websites that name prescription drugs’ which would change the meaning of your question.

Once again thank you for advising Medicines Australia of these matters. Medicines Australia takes all complaints from healthcare professionals seriously and at all times endeavours to ensure that all companies, whether member or non member of Medicines Australia, comply with the provisions of the Code.

If I can be of any further assistance please do not hesitate to contact me via phone or email.

Regards

Heather Jones
Manager Marketing Strategies, Medicines Australia

From Peter Mansfield

Heather,

Thank you for your email of 22 March. I am sorry I have not had time to reply until now.

Thank you for adding to the ‘What is Medicines Australia Code of Conduct?’ page of your website the contact details for where complaints can be sent including an email address. Another place where it would be logical and helpful to have that information is in the answer to the ‘FAQ’: ‘How can a complaint be made?’ If you want to give the impression that you are trying to make it easy for people to make complaints then you could also put that information on the ‘Code of Conduct’ page.

Thank you also for forwarding my concerns about the Eli Lilly website as a formal complaint. I would prefer to receive the minutes both as an email and as a hard copy to the postal address below. Thank you for giving me a choice.

Regarding the definition of promotion.

Did the Australian Competition and Consumer Commission and / or the Therapeutic Goods Administration specifically endorse the definition of promotion given in the glossary of the Medicines Australia Code?

The definition given in the Code is open to a significantly narrower interpretation than the definition of an advertisement in the Therapeutic Goods Act 1989. For example a bill board with only the name of the product, eg Cialis, would definately be included under the Act but could be excluded under the code because such an ‘advertisement’ does not include: ‘any statement made by a company or company’s representative, whether verbal or written, which conveys the positive attributes of a product which extend beyond a simple non-qualitative or quantitative description of the therapeutic category or approved indication for the purpose of encouraging the usage of that product.’

I confess I have no idea what the phrase ‘simple non-qualitative or quantitative description’ means. Would you please explain it to me with examples that are just inside and just outside of that definition. Depending on interpretation of that phrase it seems that even if the billboard had the words ‘Cialis for erectile dysfunction’ it would still not be included in the Code’s definition. Furthermore for all I know a claims such as ‘Cialis helps make penises hard’ and ‘Cialis helps make penises very hard’ might still not be included as promotion under the Code.

I suggest that the current definition in the Code be replaced with ‘promotion includes any thing or any activity that is intended or likely to have the effect of increasing the use or supply of products or services.’

Thank you for pointing out my ‘typo’. I did intend ‘of’ rather than ‘or’. My request for legal advice was intended to cover inclusion of drug names anywhere in a company sponsored website. I had believed that to be illegal in Australia but would appreciate advice as to whether it is legal or not as well as whether it is regarded as a violation of the Code or not.

Thank you.

regards,
Peter

From: Heather Jones [mailto:heather.jones@medicinesaustralia.com.au]
Sent: Tuesday, 4 May 2004 12:27 PM
To: .(JavaScript must be enabled to view this email address)
Subject: Extract of the Minutes from April Code Meeting

Dr Mansfield

Please find attached the extract of the minutes in relation to your complaint against Eli Lilly and the Cialis website. You will note in the letter that this matter is confidential until the appeals process is completed. Eli Lilly have 5 working days in which to notify Medicines Australia if they wish to appeal. I will notify you either way of their intention.

In response to your request that information on how to lodge a complaint be included under the FAQ section – this has now been updated on the website.

In relation to your question on ACCC endorsement of the definition of promotion – In providing authorisation of Edition 14 of the Code the ACCC agreed that the Code complements and encourages compliance with Section 52 of the Trade Practices Act (which prohibits misleading and deceptive conduct) and the Therapeutic Goods Act’s prohibition of direct-to-consumer advertising. In late 2004 Medicines Australia will commence a review of Edition 14 of the Code. All comments re changes to the Code proceeding this date will be forwarded to the Review Panel for its consideration and discussion with the relevant agencies and organisations.

The phrase “simple non-qualitative or quantitative description” means a simple statement that reflects the indications or use of the product rather than what would be regarded as promotional statements such as ‘greater efficacy at Day 5 than product Y’ or ‘faster onset of action’.

If you have any further questions please do not hesitate to contact me via email or phone.

Regards

Heather

From: Peter R Mansfield
Sent: Thursday, 13 May 2004 8:36 PM
To: Heather Jones
Subject: RE: Extract of the Minutes from April Code Meeting

Heather,

I would like to appeal the Code of Conduct Committee’s decision about the Cialis website. Please tell me the procedure.

If you have sent me a message about whether Lilly have decided to appeal or not, I have not received it yet.

regards,

Peter

Dr Peter R Mansfield

From: Heather Jones [mailto:heather.jones@medicinesaustralia.com.au]
Sent: Friday, 14 May 2004 3:51 PM
To: Peter R Mansfield
Subject: RE: Extract of the Minutes from April Code Meeting

Dear Peter

Section 13.1 of the Code states that a subject company who has been found in breach of the Code may lodge an appeal. Currently there is no opportunity for a complainant to appeal the decision of the Code Committee.

Unfortunately due to senior Eli Lilly staff being away from the office they were unable to review the minutes of the Code meeting until late this week and I have just been advised that they will not be appealing the decision of the Code of Conduct Committee.

Regards

Heather

From: Peter R Mansfield
Sent: Friday, 14 May 2004 7:08 PM
To: Heather Jones
Cc: ‘Jureidini, Jon (CAMHS)’
Subject: RE: Extract of the Minutes from April Code Meeting

Heather,

I won’t quibble over a few days delay. However the other issues are important.

The lack of opportunity for complainants to appeal is unfair. Please add allowing complainants to appeal (with hearings held at locations that are convenient for complainants) to the list of improvements to be made to the code at the next revision.

Meanwhile, do you have any suggestions about what I can do to advance my concerns about the Code of Conduct Committee’s decision in a constructive way? For example may I write a letter to them? To assist me to write to the Committee may I please have a copy of Lilly’s response to my complaint?

Some other questions

An AstraZeneca representative has claimed that the current Nexium advertising is not misleading because it has been examined twice by the Code of Conduct Committee. Unfortunately the evidence available to us indicates that it is misleading. AstraZeneca have refused to answer our recent questions so it seems that the next step is to report our concerns to the Committee. However we do not want to waste our time or the time of the Committee. Would you please send us all the relevant documents (the complaints, minutes, responses from AstraZeneca) so that we can decide whether preparing a complaint for the Committee is worthwhile or not?

It would help us to know how much we need to explain when writing to the committee if we knew more about them. Who are the current members of the Committee? What are their qualifications for evaluating advertising?

regards,

Peter
Dr Peter R Mansfield

From: Heather Jones [mailto:heather.jones@medicinesaustralia.com.au]
Sent: Wednesday, 19 May 2004 1:40 PM
To: Peter R Mansfield
Subject: RE: Extract of the Minutes from April Code Meeting

Dear Peter

Thank you for your email in relation to the outcome of the Cialis complaint and your request for information on Nexium complaints heard by the Code of Conduct Committee.

Medicines Australia will place the issue of complainant appeal on the agenda for the next review of the Code. Medicines Australia would be happy to refer this and any other suggestions you may have in relation to the Code to the Code Review Group which will commence work in August/September this year.

If you would like to write to the Committee concerning the Cialis complaint you may address your letter to the Chairman, Code of Conduct Committee c/- Medicines Australia and it will be forwarded to him. It is not possible to provide you with the Eli Lilly response to your complaint.

In relation to the membership of the Code of Conduct Committee, it comprises the following members:

Full Membership

• Chairman or Deputy Chairman - Lawyer with Trade Practices experience
Expertise within the industry, thorough understanding of the Code provisions

• Representative of the Australian Medical Association
Practising GP – advice to the Committee on how a GP may view a claim or promotional material or activity

• Representative of the Royal Australian College of General Practitioners
Practising GP – advice to the Committee on how a GP may view a claim or promotional material or activity

• Representative of the Australian Divisions of General Practice
Practising GP – advice to the Committee on how a GP may view a claim or promotional material or activity

• Representative of a patient support group, preferably with specialist qualifications.
Specialist - advice to the Committee on how another healthcare professional may view a claim or promotional material or activity

• Representative of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists
Offers Committee expertise an understanding in pharmacology and toxicology and in interpreting studies used to support promotional claims

• Representative of a Consumers’ Organisation
Consumer perspective

• 3 x Medicines Australia Association Representatives

• 2 x Medicines Australia Medical/Scientific Directors

Advisers
• Code of Conduct Secretary
• Medicines Australia Chief Executive Officer or delegate
• Medicines Australia officer responsible for Scientific and Technical Affairs

Observers
• Representative of the Therapeutic Goods Administration
• A member of Medicines Australia’s Marketing Working Group
• Two employees of Medicines Australia member companies
• An observer interested in the Code process

The members are nominated by their respective organisations as a person of genuine interest and expertise.

Advisers and observers at the Code of Conduct Committee meetings have no voting rights.

In relation to your request for access to complaint submissions, responses and minutes from complaints to which you were not a party, Medicines Australia does not disclose this information. However a summary of the outcomes of all complaints is included in the Code of Conduct Annual Report (July – June and published in September each year). The 2003 Annual Report is available on the Medicines Australia website. Also on the website are the outcomes of complaints received from July – December 2003. The 2003/2004 annual report will be placed on the Medicines Australia website in September. I would note that Medicines Australia guarantees that individual healthcare professionals will not have their name provided to a company or published in the annual report if that is their wish. Please let me know if you would like your name kept confidential in relation to publication in the Annual Report.

If a complainant has concerns or requires assistance in preparing a complaint, Medicines Australia will provide assistance as required, for example to identify sections of the Code relevant to their complaint. The Committee does not have any prescribed format or length for complaints. The complaint should clearly identify what advertisement, promotional piece or activity that is considered to be in breach of the Code. If possible it should provide supporting evidence as to why the claim(s) or activity is in breach. Appendix 1 of the Code describes what is expected in relation to intercompany complaints (page 128). While this is not required if a complaint is lodged by a healthcare professional or member of the general public, it assists the Committee if the complainant provides as much detail and supporting information as possible when submitting a complaint.

Please be assured that Medicines Australia takes all complaints seriously and will forward them to the Code of Conduct Committee for their consideration.

Regards

Heather

From: Peter R Mansfield [mailto:peter@healthyskepticism.org]
Sent: Thursday, 20 May 2004 4:39 PM
To: ‘Heather Jones’
Subject: RE: Extract of the Minutes from April Code Meeting

Heather,

Thank you for the information.

I am happy to have my name and my organisation’s name disclosed in your reports.

Please visit www.healthyskepticism.org and click on AdWatch and advise me on how best to format our concerns about the promotion of Nexium and Augmentin into complaints for the Code of Conduct Committee. We would appreciate all the assistance you are willing and able to give us.

Thank you.

regards,
Peter
Dr Peter R Mansfield

Sunday, 4 July 2004 11:39 AM
Heather,

Please find below an email I sent to you on 20 May 2004 (over 6 weeks ago).

I accepted your offer that “If a complainant has concerns or requires assistance in preparing a complaint, Medicines Australia will provide assistance as required, for example to identify sections of the Code relevant to their complaint.”

I have not yet received a reply.

Please acknowledge this email and let me know your plans re answering my request for advice.

regards,

Peter

Dear Peter

Thank you for your email of 20 May requesting assistance in the formulation of complaints to the Code of Conduct Committee in relation to Augmentin and Nexium reviewed on Adwatch. It is not the role of the Medicines Australia Secretariat to state whether any specific advertisement or item of printed promotional material is in breach or potentially in breach of the Medicines Australia Code of Conduct. If a healthcare professional considers a particular advertisement is in breach of the Code they are encouraged to lodge a complaint which will be considered by the Code of Conduct Committee. The Medicines Australia Secretariat will identify which sections of the Code may apply to the concerns raised by the complainant and will request the Subject Company respond to the complaint under identified sections of the Code – this may be additional to the areas included in the letter of complaint.

Some provisions you may wish to consider when reviewing the advertisements for Augmentin and Nexium for compliance with the Coe of Conduct.

• In relation to PBS listing information – if you are of the view that the advertisement is not an accurate reflection of the PBS listing then you could lodge a complaint under Section 3 – see preamble and explanatory notes. Further information about PBS disclosure requirements are included in the Code of Conduct Guidelines which can be found on the Medicines Australia website under Code of Conduct.

• Under the provisions of Section 3.1 advertisements may only include reference to the indications included in the current approved PI – if there is any reference to indications outside the a PI complaint can be filed under Section 1.3.1 Unapproved products or indications.

• If a healthcare professional considers that any information in promotional material is not current, accurate or balanced or is misleading, a complaint can be lodged under Section 1.1 Responsibility, 1.3 False and Misleading Claims and 1.7 Comparative Statements.

• If you consider that there is insufficient evidence to support a claim then a complaint can be lodged under Section 1.2 of the Code.

I also refer you to the Code of Conduct Annual Report which includes information about two complaints in relation to Nexium. I can also advise that the claim “Augmentin delivers first time” was considered by the Code of Conduct Committee in 2002 in the context of a previous advertisement and was not found in breach of Sections 1.3 or 1.7 of the Code.

The 2003 Code of Conduct Annual Report and an interim report for the six months from July – December 2003 are available on the Medicines Australia website.

I hope that this information will assist you in relation to these advertisements.

Heather Jones

 

 

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