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SKB promotes Augmentin in Central America

January 2000

SKB promotes Augmentin (amoxicillin and potassium clavulinate) in Central America with the claim that "generic producers do not reach the standard of quality of SmithKline Beecham".

SKB promotes Augmentin (amoxicillin and potassium clavulinate) in Central America with the claim that “generic producers do not reach the standard of quality of SmithKline Beecham”.

This month’s topic is an anti-generic advertisement for Augmentin published by SKB Costa Rica. It was sent to us by Dr Benoit Marchand of AIS-Nicaragua (Health Action International). He has informed us that he obtained it in Jinotega, Nicaragua during a medical congress at the beginning of 1998. He has also informed us that it was used throughout Nicaragua during 1998.

Unless the doctors who were influenced by it during 1998 have received corrective information it will still be having an effect. The belief that more expensive drugs are better than cheaper ones is understandable and widespread. However it is often not justified. When it is not justified the belief that more expensive drugs are better than cheaper ones can lead to wastage of scarce health care resources. The consequences can be tragic.

Unless SmithKline Beecham can justify their anti-generic advertisement it appears to be a serious attack on the work of many organisations such as the World Health Organisation’s Essential Drugs and other Medicines department towards improving access to essential drugs for less wealthy people around the world.

MaLAM has written to SmithKline Beecham about the misleading promotion of Augmentin many times since August 1983. We have been particularly concerned about the promotion of Augmentin for use in general practice for infections such as otitis media and sinusitis. These indications are interesting because it appears that antibiotics make little or no clinically important difference. We are aware of only one placebo controlled trial of Augmentin for otitis media. That trial found no significant difference. We have not been able to locate any placebo controlled trials of Augmentin for sinusitis. SmithKline Beecham has not been able to provide any evidence to show that Augmentin has superior efficacy to placebo, let alone alternative antibiotics, for either of those infections. Furthermore Augmentin appears to cause a higher rate of adverse reactions than alternatives especially in children.

There is a copy of SmithKline Beecham’s anti-generic advertisement below.

Image 1

Mr Jan Leschly
Chief Executive
SmithKline Beecham
SB House, Brentford
Middlesex TW8 9BD
United Kingdom

re: the promotion of Augmentin (amoxycillin/clavulanate)

Dear Mr Leschly,

Your 1998 Annual report claimed that “our strength lies in what we value: customers, innovation, integrity, people and performance. At SmithKline Beecham, we are people with purpose, working together to make the lives of people everywhere healthier, striving in everything we do to become The ‘Simply Better’ Healthcare Company as judged by all those we serve: customers, shareholders, employees and the global community.”

We are concerned about an advertisement for Augmentin published by your company in Central America during 1988. During 1999 a doctor in Nicaragua asked MaLAM [1] to write to you about it. This advertisement features a picture of a white powder captioned “Clavulanato de potasio desarrollado y manufacturado por SmithKline Beecham” (Potassium clavulinate developed and manufactured by SmithKline Beecham) and a picture of a yellow powder captioned “Clavulanato de potasio usado en los productos genéricos” (Potassium clavulinate used in the generic products) and claims that:

“Augmentin
Su nivel de pureza inspira confianza

Its level of purity inspires confidence

Cualquier cambio en la coloración está asociado con la degredación del clavulanato o con la presencia de impurezas

Any change of coloration is associated with degradation of potassium clavulinate or the presence of impurities

La farmacopea británica describe al clavulanato de potasio como un polvo blanco.

The British Pharmacopeia describes potassium clavulinate as a white powder

En la experiencia do SmithKline Beecham, cuando el clavulanato do potasio cambia de color (amarillo o café) es indicativo de impurezas o degradación.

In the experience of SmithKline Beecham when the colour of potassium clavulinate changes it indicates impurities or degradation

Los prinipios activos de los productos genéricos no alcanzan los estándares de calidad de SmithKline Beecham.

The active ingredients from generic producers do not reach the standard of quality of SmithKline Beecham

Augmentin Sólo hay uno.”

Augmentin The only one to have

The advertisement does not provide any citations to support any of those claims.

This letter is intended to give you the opportunity to express your point of view so that we can assess whether your claims assist appropriate therapy. We hope that you will either provide evidence to support your claims or reconsider the promotion of Augmentin. We hope that dialogue can lead to improvements in drug promotion to the benefit of the public, health professionals and your company.[2]

Initial response.

Your ad comparing Augmentin and a generic brand focuses on the difference in colour between the two products. Your assertion is that the colour of the generic product means that it either contains impurities or is the result of degradation. The implication must be that the generic product will be clinically inferior to SmithKline Beecham’s brand because otherwise these differences are of no importance. However, the advertisement provides no clinical evidence to support that implication. The use of non-clinical information such as colour, speed of action, alleged pharmacokinetic superiority, potency, surrogate endpoints such as microbiological sensitivity etc. is not an acceptable way of making comparisons between two products because clinical superiority can only be established by comparative clinical trials.

Questions:

1. Does SmithKline Beecham have any clinical evidence to show that the generic product pictured in the advertisement is clinically inferior to Augmentin?

2. If so, has SmithKline Beecham published that evidence?

3. If not, why not?

4. Does SmithKline Beecham believe that claims that one product is superior to others should be made or implied in the absence of comparative clinical trials?

5. Do you support the claim made by your company in Central America that “generic producers do not reach the standard of quality of SmithKline Beecham”?

6. If so, how can you justify such an extreme claim?

7. If not, what measures will be taken to ensure that similar errors cannot occur again?


Yours sincerely,

Dr Joel Lexchin MD, CCFP (EM), DABEM
Secretary, MaLAM Inc www.camtech.net.au/malam

References:

[1] Mansfield PR. MaLAM, a medical lobby for appropriate marketing of pharmaceuticals. Med J Aust 1997; 167: 590-592

[2] Barlow J, Møller C. A complaint is a gift: using customer feedback as a strategic tool. Berrett-Koehler San Francisco 1996
March 2000

Mr Jan Leschly
Chief Executive
SmithKline Beecham
SB House, Brentford
Middlesex TW8 9BD
United Kingdom

I have read the MaLAM International edition about the promotion of Augmentin by your company in South America.

 

(Please tick where appropriate)

I am a: doctor

pharmacist

nurse

……………………….. 

and would appreciate receiving a personal copy of your reply. q

Yours sincerely,

 

 

 

HS Int News index

 

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