Healthy Skepticism Adwatch on Augmentin Australia February 2004

"Take a closer look": Augmentin (amoxicillin with potassium clavulanate) from GlaxoSmithKline

For example, antibiotics are still prescribed for around 75% of acute bronchitis visits.[1] This is despite strong evidence that the benefits do not exceed the adverse effects[2] except perhaps in subgroups such as people over age 55 with frequent daytime cough.[3]

Overuse of antibiotics is accelerating the evolution of resistance that will soon lead to many avoidable deaths.[4]

One of the main uses of advertisements is to maintain high prescribing rates for older drugs[5] such as Augmentin.

The following Augmentin advertisement was based on sophisticated research. We suspect that every element of the advertisement was carefully chosen. Let’s take a closer look at GlaxoSmithKline’s techniques for overcoming resistance to prescribing Augmentin.

Our opinion:
Caring is a good motivation but caring too much can lead to over treatment. Providing special care for an individual by breaking the guidelines for good treatment can boost a doctor’s self esteem. However this may harm the patient and/or the community.

Our reading:
This promotes focus on resistance as the main or only criteria for choosing an antibiotic.

Our opinion:
Resistance is just one factor to take into account when considering drug choices. Resistance in the petrie dish does not always predict benefits for patients. We also need to consider the rate at which the infection resolves naturally (without antibiotics), the rate and type of adverse reactions and the value of the antibiotic in severe/life threatening infections where there are few antibiotic alternatives. Cost is sometimes a consideration. Resistance can't be ignored but is not the main criterion.

References:
One conference poster and two reviews of pharmacokinetics and pharmacodynamics.

Our opinion:
The advertising copy does not specify which infections it refers to so it could refer to all infections including acute bronchitis. This appeals to our desire for the simplicity of a one size fits all antibiotic.

The implication that Augmentin delivers a 100% cure rate appeals to our desire to avoid failure and ensure that patients don’t have to pay for a second antibiotic.

The most common infections in young women include colds and acute bronchitis for which antibiotics are not needed and urinary tract infections for which Augmentin is not recommended as the first choice. The references cited in the advertisement do not support any of our readings of the claim.

“GlaxoSmithKline (GSK) promotes Augmentin Duo Forte within the TGA approved indications in line with the requirements of the Medicines Australia Code of Conduct.”

We asked GSK to answer our questions individually but they just repeated that answer. See Correspondence with GSK below.

The fine print lists the following indications “community acquired pneumonia and acute exacerbations of chronic bronchitis, upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis”

Our opinion:
Those indications were approved by the Therapeutic Goods Administration but are not up to date.

According to Therapeutic Guidelines Antibiotic (October 2003) [6] the current first line indications for Augmentin are:

Augmentin is not recommended first choice but is an option for the following indications.

PBS Information
(PBS = Pharmaceutical Benefits Scheme, the Australian system of subsidies for drugs. Augmentin is subsidised by the PBS if used for "Infections where resistance to amoxycillin is suspected or proven.")

“Augmentin should be used in infections where resistance to amoxicillin is suspected or proven.”

Our reading:
The PBS indication is ambiguous but GSK have misquoted the PBS by adding the clause "should be used" and thus make it more promotional.
Reasonable readings include: “Augmentin should always be used first line because amoxicillin resistance is always a possibility” and this is the recommendation of the PBS.

Our opinion:
Augmentin is not good enough for first line use because:
Augmentin has a higher rate of adverse effects including diarrhoea and liver damage than amoxicillin.
Augmentin’s broad spectrum increases the risk of evolving resistance.

Our reading:
This appeals to our desires to avoid conflict and to please our patients. It also reinforces the perception that patients want antibiotics.

Our opinion:
Patient requests are a major factor in inappropriate antibiotic prescribing for acute bronchitis.[8] [9] One study suggests that Australian general practitioners’ perceptions of patients’ expectations are a major influence on prescribing.[10]

Reinforcing Images:
Attractive young woman in upmarket surroundings with stereotype clues denoting intelligence: brunette with glasses.

Our reading:
Sue represents attractive intelligent high status young professionals.

Our opinion:
Many young Australian adults believe that antibiotics are appropriate for coughs, colds and ’flu-like symptoms and will enable them to return to work more quickly. [8] [11]

Advertising is often based on sophisticated research about decision making that is not in the public domain. There is published evidence that that people who are likeable, physically attractive, and /or similar to us can be even more effective at influencing us than we already realise.[12] Consequently this advertisement may be based on specific evidence that the attractive intelligent high status people that “Sue” represents are particularly difficult for some doctors to say no to.

Acute bronchitis

Acute bronchitis is defined as acute viral or bacterial infection of the larger airways in otherwise healthy young adults and children who do not have a history of recurrent disease.

In an immunocompetent adult or child, acute bronchitis is most often viral and does not require antibiotic therapy. Although bacterial colonisation and purulent sputum are common complications, randomised controlled trials show that antibiotic therapy provides no overall benefit to the patient and may cause harm. Pertussis should be considered in patients with persistent paroxysmal cough. Pneumonia should be considered in patients with more severe illness.

(Feedback will be be used as a basis for dialogue with GSK and regulatory agencies including the Medicines Australia Code system. We will also take feedback seriously for improving future editions of AdWatch because we believe that a complaint is a gift for quality improvement.)

[1] NPS News April 2003 Issue 27

[2] Smucny J, Fahey T, Becker L, Glazier R. Antibiotics for acute bronchitis (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.

[3] Arroll B, Kenealy T. Antibiotics for acute bronchitis. BMJ, Apr 2001; 322: 939 - 940. http://bmj.bmjjournals.com/cgi/content/full/322/7292/939

[4] WHO Global Strategy for Containment of Antimicrobial Resistance. Geneva: WHO; 2001 www.who.int/csr/resources/publications/drugresist/WHO_CDS_CSR_DRS_2001_2_EN/en/

[5] Lidstone J, Collier T. Marketing Planning for the Pharmaceutical Industry. Aldershot UK, Gower 1987

[6] Electronic Therapeutic Guidelines Complete. Melbourne: Therapeutic Guidelines Ltd; October 2003

[7] Electronic Therapeutic Guidelines Complete. Melbourne: Therapeutic Guidelines Ltd; October 2003

[8] Macfarlane J, Holmes W, Macfarlane R, Britten N. Influence of patients' expectations on antibiotic management of acute lower respiratory tract illness in general practice: questionnaire study. BMJ, Nov 1997; 315: 1211 - 1214. http://bmj.bmjjournals.com/cgi/content/full/315/7117/1211

[9] Mintzes B, Barer ML, Kravitz RL, Bassett K, Lexchin J, Kazanjian A, Evans RG, Pan R, Marion SA. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. Can Med Assoc J 2003; 169: 405-12 www.cmaj.ca/cgi/content/full/169/5/405

[10] Cockburn J, Pit S. Prescribing behaviour in clinical practice: patients' expectations and doctors' perceptions of patients' expectations: a questionnaire study. BMJ 1997; 315: 520 - 3

[11] NPS News June 2000 Issue 10

[12] Cialdini, R. B. Influence: Science and practice. 4th ed. Boston: Allyn & Bacon; 2001.

We would like to give you the opportunity to comment before we publish AdWatch on Augmentin.

3. What meaning do you intend GPs to take from the claim that “Augmentin delivers first time”?

Obviously you can't answer question 5 until we send you the current draft (as a MS Word doc). Unfortunately you don't provide an email address so I can't send it to you today. If you provide an email address then I will send it to you when I return from interstate on Wednesday 19 November.

Dr Peter R Mansfield
GP
Research Fellow, Department of General Practice, University of Adelaide
NHMRC Public Health Postgraduate Scholarship 250465
Director, Healthy Skepticism Inc
Improving health by reducing harm from misleading drug promotion.
peter@healthyskepticism.org
www.healthyskepticism.org
Flinders University Convocation Medal 2003
34 Methodist St, Willunga SA 5172 Australia
ph/fax +61 8 8557 1040

Dear Dr Mansfield

We received your request via our website for comment on your publication of Adwatch.

GlaxoSmithKline (GSK) promotes Augmentin Duo Forte within the TGA approved indications in line with the requirements of the Medicines Australia Code of Conduct.

sincerely

Nikki Capp
Corporate Affairs Manager
GlaxoSmithKline Australia

Whilst I thank you providing such a concise response, I believe all involved may benefit if you provide separate answers for each of our questions:

6. Would you please confirm or deny that the choice of an attractive young female of high status for the Augmentin advertisement was based on evidence that such people are able to influence doctors?

8. If you don't confirm, would you please tell us why an attractive young female of high status was chosen for the Augmentin advertisement?

Dear Dr Mansfield

Thank you for the opportunity for further comment. For all involved: GlaxoSmithKline (GSK) promotes Augmentin Duo Forte within the TGA approved indications in line with the requirements of the Medicines Australia Code of Conduct.

sincerely

Nikki Capp
Corporate Affairs Manager
GlaxoSmithKline Australia

If at anytime your company wishes to commence dialogue with us we will be happy to cooperate. We are very keen to receive feedback to help us improve our performance. The following quotes may help you to understand our thinking regarding feedback. I hope you find them helpful.

"companies will have to become more flexible, and respond more quickly and efficiently following customer feedback"
Who are the pharmaceutical industry's customers? Scrip 2003 July 1;2865:14

"When customers feel dissatisfied with products and services, they have two options: they can say something or they can walk away. If they walk away, they give organizations virtually no opportunity to fix their dissatisfaction. Complaining customers are still talking with us, giving us an opportunity to return them to a state of satisfaction so they will be more likely to buy from us again. So as much as we might not like to receive negative feedback, customers who complain are giving us a gift.

If we shift our perspective in this way to see complaints as gifts, we can more readily use the information the complaints generate to grow our own businesses. Customer complaints are one of the most available and yet underutilized sources of consumer and market information; as such, they can become the foundation for a company's quality and service recovery programs. This is no small gift!

In order to better understand complaining customers, Part 1 of this book examines the behavior and desires of dissatisfied customers. With understanding comes acceptance. We must welcome these complaining customers and make them want to come to us with their feedback."
Barlow J, Møller C. A complaint is a gift. Using customer feedback as a strategic tool. Berrett-Koehler Publishers. San Francisco 1996

Current second choice indications for Augmentin[7]	First choice antibiotic
acute cystitis in non-pregnant women	trimethoprim 300 mg daily for 3 days
acute cystitis in non-pregnant women	cephalexin 500 mg 12-hourly for 10 days
acute cystitis in children	cephalexin 12.5 mg/kg up to 500 mg 12-hourly for 5 days
acute cystis in men	trimethoprim 300 mg daily for 14 days
epididymo-orchitis	trimethoprim 300 mg daily for 14 days

Antibiotic	Price per tablet	Price per day
trimethoprim 300mg 1 daily	$1.05	$1.05
cephalexin 500mg 2 daily	56 cents	$1.12
amoxicillin 500 mg 3 daily	55 cents	$1.65
Augmentin 875mg/125mg 2 daily	$1.70	$3.40

Please note this AdWatch issue is no longer active so you can not submit answers to the questions below.