r. Justice Lloyd Brennan of the Ontario Courts
General Division is to be commended for his decision to grant
an injunction against Ross Laboratories. Justice Brennan quoted
the WHO International Code in his decision, and recognized that
the Ross advertising violated the Code, on several fronts, including
direct marketing to the public.
Competitor Mead Johnson had sought the injunction. Ross claimed that its product offered benefits previously only associated with breastmilk-strengthening infant immune system and providing protection against infection. According to Dr. Jack Newman, chairperson of INFACT Canada's Board and director of Toronto breastfeeding clinics, women have asked him about switching from breastfeeding after hearing product claims. The advertising has been very persuasive.
Justice Brennan ordered Ross to withdraw its advertising, and further to recover all product packages and materials "which contain any ...of the offending representations." This action is a restraining injunction, and the issue will still have to go to full trial to decide whether the advertising represents unfair competition to Mead Johnson.
Ironically it was only last year that Mead Johnson was asked by Health Canada to remove the claim, "modeled after mother's milk" from its tins.
One wonders shouldn't Health Canada be more actively exercising its responsibilities as signatory to the WHO International Code?
Physician and INFACT Canada member, Joel Lexchin of Toronto, summarized the issue in a letter to the Canadian Family Physician, September 1996, as follows:
...Twelve references were cited in the ad supporting the scientific claims. I wrote to Abbott requesting a copy of all 12 references. After two letters and about 7 weeks of waiting, Abbott sent all the references by courier. Eight of the 12 are in abstract form, meaning that the publication has not been subjected to peer review and that the material is available only in brief summary form. Nine of the studies were either supported by Ross Pediatrics or written by at least one author employed by the company.
There is often a discrepancy between the claims in the ads and the material in the references; clinically relevant information in the reference is omitted in the ad, or the clinical significance of the claim is unclear:
"Helps strengthen the baby's developing immune system." The reference gives titre levels against Haemophilus species, polio and diphtheria but does not claim any clinical significance for the differences observed.
"Decreases the incidence of diarrhoea." Diarrhoea was not defined in the reference. The study was done on Chilean infants, and the relevance to the Canadian situation is unclear. Furthermore human milk offered the same level of protection.
"Meets the Canadian Paediatric Society's guidelines for iron supplementation throughout the first year." While the statement form the Canadian Paediatric Society does give recommendations, it goes on to say that "studies are still under way to determine the optimal iron content of these [iron-fortified infant] formulas."
"Alleviates the concern for constipation that some associate with iron-fortified formulas." The reference cites a study on stool consistency, not constipation.
"Provides plasma essential amino acid patterns closer to those of breastfed infants." The authors developed a mathematical equation to summarize the closeness of the plasma amino acid profiles by human milk and various formulas, but the clinical significance of any differences was not stated. Although the reference states that differences were compared by ANOVA and Dunnett's test, no values were given.
"Provides stool consistency close to that of breastfed infants..." No statistical analysis is provided in the reference.
"Supports visual, cognitive and psychomotor development close to that of the breastfed infant." In one of the studies , breastfed infants were allowed commercial formula from ages 3 to 12 months and therefore might not be a true control group. The two references, fail to state whether the breastfed group also received formula. According to two references, the type of formula made no difference to visual acuity. In the study on vocabulary production and comprehension, infants fed Similac Advance and breast milk were not directly compared, so just how closely Similac Advance mimics breast milk is unknown.
"Delivers excellent fat and calcium absorption." Similac Advance was compared only with another formula, not breast milk. No clinical correlation is made.
"A new blend of nucleotides with the same levels as those available in breast milk." The reference makes no mention of Similac Advance.
"A unique fat blend with improved alpha linolenic acid ratio and appropriate levels of alpha linolenic acid." Neither of the two references mention Similac Advance; it is therefore unclear what Similac Advance is an "improvement" over or the clinical significance of this "improvement."