Nucleotides and misleading claims

Any statement, warranty or guarantee of the performance, efficacy or length of life of a product not based on adequate and proper test is prohibited.
--Unsubstantiated claims [Section 52(1)(b)], Competition Act, Industry Canada

As science has so abundantly documented over the past number of years, breastmilk contains a multitude of complex ingredients that provide important immunological support. The intricacies of mother’s milk–the antibodies, secretory IgA, lysozymes, macrophages, lactoperoxidases, lactoferrin, oligosaccharides, gamma-interferon, bifidus factor, lymphocytes, hormones and growth factors–all contribute to the protective marvels of mother’s milk.

Nucleotides, just one ingredient in this complex interactive immunity development potential of breastmilk, have been getting attention in a way that they do not deserve. You may recall the launch of Ross Similac Advance (See INFACT Canada Newsletters Spring ‘96, Fall ‘96) with overblown claims: “new and improved” product “helps strengthen your baby’s developing immune system in ways closer to breastmilk.” Fearing market loss, competitor, MeadJohnson, won an injunction against Ross to have the “offending” promotions removed from all product literature and labels.

At the time of the claims, INFACT member, Dr. Joel Lexchin, took a close look at the references Ross used to make its claims, and found substantive evidence lacking. He found studies (8 out of 12) only available as abstracts. Some failed to make clinical significance and some used mixed feed controls. Nine were either supported by Ross or written by Ross employees.

Much of the controversy surrounding the Ross claims centred on the “Pickering study.”(1) Now, one year after the apparent claims, the Pickering study has been released. It says:

• Funding was “provided by Ross Products Division, Abbott Laboratories and NIH-HD 13021.”
• Six of the nine researchers were Ross employees.
• In the breastfed group, infants were exclusively breastfed to two months and then could switch to Similac with iron.
• Infants were immunized for DTP (diptheria toxoid), OPV (oral polio virus), and Hib (Haemophilus influenza type b) with the following responses:
• Breastfed infants showed significantly higher antibody responses to OPV... than the test or routing formula group and the response was dose related.
• Enhanced OPV antibody responses were not found in the nucleotide supplemented formula group.
• Some (only modest) increased response was observed for DTP and somewhat more for Hib.
• No enhanced antibody response was observe for tetanus toxoid.

Despite the marginal outcomes, the study makes the sweeping conclusion that “In summary, human milk and infant formulas supplemented with nucleotides enhance infant immunity as measured by antibody response...”

“Are the Ross representations a fair statement of the Pickering conclusions? Judge J. Brennan of the Ontario Court of Justice asks in his MeadJohnson vs. Ross summation, “Having seen the elaborate brochure directed at the medical profession and the attractive documents presented to potential purchasers, I consider that a reasonable person would take them to mean that a scientific breakthrough had occurred. The relative modest conclusions of the Pickering Study ... do not appear at this stage to justify the hyperbole which characterizes the Ross promotion program.”

1. Pickering, L.K. et al. Modulation of the Immune System by Human Milk and Infant Formula Containing Nucleotides. Pediatrics 101:242-249, 1998 BACK