Healthy Skepticism International News
SmithKline Beecham Ambatrol (nifuroxazide)
June 1997
Vol 15 Issue 5/6 This month's letter: SmithKline Beecham's promotion of Ambatrol (nifuroxinde) Smith Kline Beecham claims Ambatrol "treats the cause" This month, MaLAM's letter has been prepared by PIMED (Pour une Information Medicale Ethique), the French distributor of MaLAM. It features a promotional brochure distributed in the Ivory Coast by SmithKline Beecham. The illustrations and the claims in this brochure promote Ambatrol (nifuroxazide) as an effective treatment to prevent dehydration and "neutralise microbacterials" in diarrhoea. It is also said that Ambatrol has "a spectrum which covers most enteropathogenic microbacterials, Shigella, Escherichia Coli, Salmonella, Staphylococci, Klebsiella, Yersinia...". We have not found any scientific evidence to support these claims. Furthermore, they are not even consistent with the Product Information which accompanies the advertisement Follow-up: Beaufour-Ipsen's promotion of Smecta (smectite) Rhône Poulenc Rorer's promotion of Flagyl (metronidazole)
Smith Kline Beecham claims Ambatrol “treats the cause”
This month, MaLAM’s letter has been prepared by PIMED (Pour une Information Medicale Ethique), the French distributor of MaLAM. It features a promotional brochure distributed in the Ivory Coast by SmithKline Beecham. The illustrations and the claims in this brochure promote Ambatrol (nifuroxazide) as an effective treatment to prevent dehydration and “neutralise microbacterials” in diarrhoea. It is also said that Ambatrol has “a spectrum which covers most enteropathogenic microbacterials, Shigella, Escherichia Coli, Salmonella, Staphylococci, Klebsiella, Yersinia…”. We have not found any scientific evidence to support these claims. Furthermore, they are not even consistent with the Product Information which accompanies the advertisement (see our letter).
Worldwide diarrhoeal diseases account for several million of deaths in children every year. In 1990, the World Health Organization published guidelines for management of diarrhoea in children which emphasise the pivotal role of oral rehydration salts, the selective role of antibiotics and antiparasitic drugs and the lack of a place for antimotility agents and adsorbents in therapy.1
Ban of all promotion of antidiarrhoeal drugs?
Despite WHO guidelines, many useless or dangerous antidiarrhoeal drugs are still registered and promoted all over the world.2 Deregistration of inappropriate drugs is a priority but should be part of a broader public health intervention to avoid irrational substitution of deregistered drugs as has been observed in some countries (in Pakistan, following the withdrawal of paediatric formulations of antimotility drugs other equally irrational therapies were used3). Responses from Beaufour-Ipsen (see below) about promotion of another antidiarrhoeal drug Smecta (smectite) clearly shows that some drug companies are very reluctant to consider public health and economic issues associated with drug promotion and only aim to increase their own profits. Regulatory authorities should consider banning the promotion of antidiarrhoeal drugs as part of all programs that aim to improve the rational treatment of diarrhoea in children.
The MaLAM letter
Beaufour-Ipsen’s promotion of Smecta (smectite)
Beaufour-Ipsen, a French drug company, widely promotes its antidiarrhoeal drug Smecta (Smectite, an adsorbent). Beaufour-Ipsen claims that “ORS [oral rehydration salts] correct dehydration, Smecta treats the symptoms”. The main study presented by Beaufour-Ipsen is a double-blind controlled study in 90 children.4 This study was initiated by the Diarrhoeal Disease Control Programme of the World Health Organization which has publicly disagreed with the way the results were analysed and has requested Beaufour Ipsen to immediately cease using the name of the WHO in promotional material relating to Smecta.
Beaufour-Ipsen also claims that “Smecta optimises the conditions for acceptance [of oral rehydration]” and misleadingly uses an anthropological study (sponsored by Beaufour-Ipsen) suggesting that the use of Smecta was necessary to improve the acceptance of ORT. The anthropological study refered to made no reference to Smecta.
Are the WHO recommendations unethical?
The only concession made by Beaufour-Ipsen in its second response to MaLAM was that the name of the company should have been mentioned in promotional articles presenting the anthropological study because it was sponsored by the company. Beaufour-Ipsen did not comment further about the misleading use of this study to promote Smecta.
Beaufour-Ipsen’s comments about the WHO recommendations for treatment of diarrhoeal diseases were that “we consider that our arguments for the use of Smecta in diarrhoea are appropriate, despite what WHO recommends” and “It seems that the problem raised by WHO is based more on economic arguments… That WHO would prevent using a product that is safe and effective seems to go against all ethical considerations” (emphasis added).
Beaufour-Ipsen’s open opposition to WHO recommendations, its dismissal of economic concerns in developing countries and its attack against WHO’s ethics should be strongly condemned and sanctioned.
Rhône Poulenc Rorer’s promotion of Flagyl (metronidazole)
The June 1996 MaLAM international edition focused on the promotion of Flagyl (metronidazole) by Rhône Poulenc Rorer (RPR) in Pakistan. An advertisement exhorted doctors to use Flagyl in all cases of diarrhoea. However, medical, epidemiological and economic data do not support the presumptive use of metronidazole in childhood diarrhoea. Only a very small percentage of diarrhoea in Pakistan are caused by amoebiasis and giardiasis (for which metronidazole is recommended). The cost of a stool examination in Pakistan is lower than the cost of one treatment course of Flagyl in a 10-kg baby. The World Health Organization states that “Metronidazole is ineffective when given as initial therapy of bloody diarrhoea, it may have side effects and its use makes treatment unnecessarily expensive. Metronidazole is never indicated for children with acute watery diarrhoea without blood. “5
The response from Rhône Poulenc Rorer Pakistan was transmitted through PIMED (our French distributor) with a covering letter from the RPR French headquarters. The letter from the Pakistani subsidiary was very short and stated that the promotion material had been withdrawn from the market and that “Flagyl is being promoted only for the proven cases within the range of the approved indications, and not as a presumptive treatment”.
The letter from the French headquarters was more detailed and stated that “on the basis of some WHO documents, we have reconsidered arguments against presumptive treatment in these clinical settings, and from now on, our promotion for Flagyl will concern only proven cases of amoebiasis and giardiasis”. We are very pleased with Rhône Poulenc Rorer’s decision which contrasts with their first response to MaLAM where they defended presumptive use of Flagyl. We invite our readers to look closely at all promotional material for Flagyl in the future and to check that RPR respects this decision. We also invite RPR to support educational interventions towards better use of drugs in diarrhoea and to correct the misuse of metronidazole which has been observed in some countries.
1. World Health Organization. The rational use of drugs in the management of acute diarrhoea in children. Geneva 1990; 71 pages.
2. Haak H et al. Regulatory actions to enhance appropriate drug use: the case of antidiarrhoeal drugs. Soc Sci Med 1996;42:7:1011-1019.
3. Bhutta TI. Assessing the impact of a regulatory intervention in Pakistan. Soc Sci Med 1996;42:8:1195-1202.
4. Madkour A et al. Smectite in acute diarrhea in children: a double-blind placebo-controlled clinical trial. J Pediatr Gastroenterol Nutr 1993;17:2:176-181.
5. Programme for control of diarrhoeal diseases. The management of bloody diarrhoea in young children. WHO/CDD/94.49 WHO Geneva 1994; 17 pages.
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