Lack of transparency? Infant formula trial review sparks debate on industry’s role

15 Oct 2021 --- A study arguing that formula milk trials have a high risk of bias has ignited a debate about transparency in the industry. NutritionInsight speaks with key players and one of the researchers about best practices in infant nutrition research. 

The review says the findings “support the need for a substantial change in the conduct and reporting of formula trials to adequately protect participants from harm and protect consumers from misleading information.”

Notably, the researchers found that of 125 trials published since 2015, only 17 (14%) of these trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and main (primary) outcome, and 11 (9%) had a publicly available protocol.

Industry safeguards needed
Nonetheless, industry-funded studies can be done in a transparent manner “but careful safeguards need to be in place,” one of the researchers, Dr Robert Boyle, reader in paediatric allergy at Imperial College London, tells NutritionInsight.

These “depend a lot on the regulatory environment and also on the probity of the independent investigators helping run the trial for the company, and any independent regulators assessing the trial results.”

“Unfortunately, all too often, the commercial pressures that the companies are under mean the research becomes biased in its conduct or reporting,” he adds.

“In most recent formula trials, investigators were employed by or had financial links to the formula industry, who were often involved in the statistical analysis and writing,” the study notes.

According to the study, 80% of trials had a high risk of bias for their primary outcome.Steps in industry
Responding to the study, experts from the infant nutrition industry also emphasize the importance of iron-clad research and communication. 

“Transparency, academic freedom and research integrity are crucial in the infant nutrition space. That’s why we have policies in place to ensure that external researchers working with us are free to conduct their research and publish their scientific conclusions,” Anne Staudt Kvistgaard, head of nutrition science at Arla Foods Ingredients, specifies. 

“We transparently disclose lists of key research priorities and partnerships and take responsibility for our contributions to publications and reports.”

FrieslandCampina notes that studies it carries out are always done with independent research institutes, and guidelines are always followed.

“We always carry out studies in close cooperation with independent research institutes, like universities. We always follow the guidelines for clinical research, taking into account the policies regarding the marketing of infant nutrition. Publications are always published in peer-reviewed papers,” Jan-Willem ter Avest, spokesperson for FrieslandCampina says. 

Danone points to a statement from the British Specialist Nutrition Association which it is a member of, highlighting that “it must be noted that infant formula is highly regulated and while feeding with breastmilk is best, infant formula is the only safe alternative. The safety of infants is our members’ highest priority.”

“Clinical trials are carried out following approval from an independent research ethics committee and must be registered on a publicly accessible database. All trial results are published – regardless of the outcome. The peer review process ensures that published results accurately reflect the findings of the trials,” it states.

High risk of bias?
The study, published in The BMJ, notes that 80% of trials had a high risk of bias for their primary outcome, usually because there were inappropriate exclusions of participants from the trials and selective reporting to suppress negative or undesirable findings. 

“We were very surprised at the almost total lack of transparency in this field of clinical investigation. Formula milk is an important product, but it seems that the science underlying the evaluation of new products is weak,” Boyle notes.

He also adds that the transparency issues in this field “appear to be greater than the issues seen in other fields of clinical research.”

“Favorable conclusions were reported for more than 90% of the trials,” the study notes.

The industry insists it does its utmost to adhere to transparency.Undermining breastfeeding?
According to the study, many of the trials researchers scrutinized also seemed to contravene the WHO’s code of marketing of breastmilk substitutes by providing free formula to parents which were breastfeeding or mix feeding their infants.

“Only 12% of trials reported adequate measures to ensure breastfeeding was not undermined in participants of the trial,” it notes. 

“Given the lack of transparency about the aims of the trials and almost universally favorable conclusions, some trials might have a marketing aim and no robust scientific aim,” the study adds.

Breast milk as the gold standard
According to Boyle, the health-promoting effects for young children that are breastfed are very powerful and continue to influence young people’s well-being even into adult life. 

“Formula milk is not necessary for the vast majority of children. There are very few, rare, medical reasons for using formula milk in place of breastfeeding.”

Earlier this year, a UK study revealed that breastfeeding provides better immunity than infant formula. 

The infant nutrition industry has long acknowledged the benefits of breastfeeding and is attempting to close the gap as much as possible, as highlighted during last year’s World Breastfeeding Week.

Infant nutrition has diversified and become more specialized, with conditions like allergies and anxiety driving a range of available options. 

There has been a growing trend of personalization where infant nutrition is concerned, ranging from products catering to specific needs, such as hypo-allergenic formula.

By Andria Kades