Scientific fraud and child health


	Scientific fraud and child health How Nestlé-funded research supported deceptive "hypoallergenic" claims Breastfeeding protects against the development of allergies. Photo by Melanie Gillis In 2002, Memorial University in Newfoundland was shocked by the early retirement of one of its most renowned scientists, Dr. Ranjit Chandra. For over twenty years, Chandra had made a distinguished career conducting research on nutrition and infant feeding and was considered a world-class expert in his field, but in 2000 his work began to unravel. The prestigious British Medical Journal rejected one of the studies he submitted to its editors, who believed the results had been faked. Over the next few years, the more Chandra’s work came under scrutiny, the more suspicious his research seemed, until finally one of his research assistants came forward to say that she had never helped him conduct several of his published studies which had been paid for by Nestlé and other infant formula companies.¹ While Chandra has packed up and headed overseas, the effects of the Nestlé studies he faked will linger on, and their publication should serve as a disturbing example of conflict of interest, greed and an industry’s callous disregard for the health of thousands of infants who suffered the consequences of self-serving marketing deceptions. Chandra’s studies^2,3 on Nestlé formula purported to prove that the company’s Good Start formula reduced the incidence of allergies in children, and justified the company’s claim that this new brand of formula was hypoallergenic – that the product could reduce atopic symptoms in infants at risk to levels similar to even better than those seen in exclusively breastfed infants. With the publication of the studies, Nestlé had a new kind of formula, a new market, and a new source of profits. Dr. Chandra got paid. Everyone was happy. But Chandra’s results just weren’t true. He never even conducted studies on Good Start formula. The Chandra scandal reveals the inherent problems with corporate funded medical research. While there is clearly a need for companies, especially those producing food products, to improve quality and safety through generally accepted scientific research, the reality is that corporations like Nestlé are also motivated by marketing needs which do not necessarily accord with objective medical research. For companies like Nestlé, the stakes resting on research favorable to their products are very high. When Chandra did his first study for the company in the late 1980s, Good Start was already being marketed as a hypoallergenic formula, and the company was under intense pressure from the Food and Drug Administration to verify its claims about the product. Had it not been able to find a study that proved Good Start reduced the risk of allergies in children, Nestlé would have been in serious trouble. So evidently they sought out Dr. Chandra, gave him significant funds to do research into the formula, and he returned the results Nestlé needed. It didn’t matter that Chandra’s work ran counter to the vast body of medical knowledge, which asserts that breastfeeding, rather than any formula, is the greatest factor in lowering the incidence of allergies. Nestlé had one study that said their formula could achieve similar results , and used this to gain a marketing edge. According to UNICEF "Formula feeding is expensive and carries risks of additional illness and death, particularly where the levels of infectious disease are high and where preparation and storage of these substitutes is not carried out properly. Many studies indicate that a non-breastfed child living in disease ridden and unhygienic conditions is between six and 25 times more likely to die of diarrhoea and four times more likely to die of pneumonia than breastfed infants. A recent study of postneonatal mortality in the United States found a 25% increase in mortality when infants were not breastfed."⁵ The Chandra studies opened up a whole new market for Nestlé. His research was cited in Nestlé formula promotions all over the world and in product monographs sent to physicians and nutritionists.⁴ Never before had allergy-prone infants been so forcefully targeted by formula companies. Despite the well-known long term health benefits of breastfeeding, parents around the globe with a history of allergies were now urged to buy Nestlé’s new "break-through" formula, and thousands did. As a result, unknown numbers of babies over the past decade and a half have been unnecessarily exposed to the risks of artificial feeding. Nestlé’s hydrolized infant formula became one of the company’s best-selling infant foods. Many more parents bought the similar products released by Nestlé’s competitors in the wake of Chandra’s bogus research. All the major formula companies aimed to increase their market shares with brands claiming to reduce the risk of allergies in children. They based these claims on corporate-funded research building on Chandra’s manufactured results. The Nancy Olivieri Case Although Nestlé has come under .re for decades for its unethical marketing of infant formula, the Chandra case illustrates a problem embedded in corporate-funded research that goes far beyond just one company. In 1998, a furor erupted when Nancy Olivieri, a researcher at the Hospital for Sick Children and the University of Toronto, went public with the results of a clinical trial she had conducted on a drug to treat a rare blood disease. She had discovered that deferiprone, a pill produced by the pharmaceutical company Apotex, was ineffective and potentially toxic in some patients. Olivieri decided that she was obligated to report the findings to her institutional review board and submit them for publication in a peer-reviewed journal, but Apotex was determined to bury her research and launched a lawsuit against her, claiming she had violated a confidentiality agreement she had signed with the company. Nevertheless, Olivieri submitted her findings for publication. At the time, Apotex was negotiating a $30 million grant to U of T and the Hospital for Sick Children. Both institutions refused to support Olivieri. Instead she was stripped of one of her positions at the hospital and publicly chastised by Sick Kids for speaking out. Finally, after a protracted legal battle, during which Olivieri alleged she was harassed for following her moral obligations, she won an undisclosed settlement from the hospital and the university in 2002. The Olivieri case garnered worldwide recognition and serves as a stunning example of the unbalanced nature of the corporation researcher relationship. Faced with unfavourable test results, companies can use confidentiality agreements to keep critical findings from the public, rendering mute the voice of the researcher. Corporations can also use their substantial financial power to pressure institutions into protecting their corporate interests. As Olivieri’s four-year struggle illustrates, it is very difficult for relatively powerless individuals to combat such tactics. References: 1. O’Neill-Yates C. The secret life of Ranjit Chandra. The National (Canada): (Three features). 31 January – 2 February 2006. [back] 2. Chandra R, Singh G. Shridhara G. Effect of feeding whey hydrolysate, soy and conventional cow milk formulas on incidence of atopic disease in high risk infants. Annals of Allergy 1989; 63: 102-6. [back] 3. Chandra R. Five-year follow-up of high risk infants with family history of allergy who were exclusively breastfed or fed partial whey hydrolysate, soy and conventional cow’s milk formulas. Journal of Pediatriatric Gastroenterology and Nutrition 1997; 24: 380-8. [back] 4. Carnation Good Start. Letter to Elisabeth Sterken from Steve Allen, Director, Nutritional Products Group, Carnation Good Start, a division of Nestlé. 31 October 1990. [back] 5.Obtainable at: http://www.unicef.org/nutrition/index_breastfeeding.html [back] Formula feeding trials raise concerns Aside from the conflicts of interest raised by corporate-funded formula trials, a larger question looms as to whether formula trials using infants are ethical. • Research using babies could have long-lasting consequences, effectively altering infants lives well into adulthood. Trials using infants should be at best a last resort, after all other methods of testing, such as animal trials, are exhausted. • Parents who subject their children to such trials must be made fully aware of the benefits of breastfeeding, and the risks of formula feeding, particularly of the experimental brand being tested. Parents should be supplied with full product information relating to the formula, including the ingredients used. • Breastfeeding, and not regular formulas, must be used as the control because breastfeeding is the acknowledged best standard of practice. Often, industry-funded trials only compare the experimental formula to a regular brand. Slight differences in the new formula allow for claims that it is "better" while it fails any comparison to breastmilk. • Parents should not be coerced into participating in trials. The request for participation should come not from their doctor or nurse, but from an outside person who is clearly partial. WHA addresses conflict of interest In 2005, the World Health Assembly passed a resolution to the International Code of Marketing of Breastmilk Substitutes addressing the problems associated with corporate funded infant feeding research. Resolution 58.32 urges Member States of the WHA: "(4) to ensure that financial support and other incentives for programmes and health professionals working in infant and young-child health do not create conflicts of interests; (5) to ensure that research on infant and young-child feeding, which may form the basis for public policies, always contains a declaration relating to conflicts of interest and is subject to independent peer review." According to the preamble of the document, the basis of the resolution was the concern that "nutrition and health claims could be used to promote breast-milk substitutes as superior to breastfeeding." In the past few years there has been a startling rise in formula health claims - based on research funded by formula companies themselves - that assert certain brands are "better" or "reduce the risk" for certain conditions. Despite these claims, medical research overwhelmingly indicates that all formulas are inferior to breastmilk as a source of infant nutrition. \| Top \| Winter 2006 Newsletters Contents \|

How Nestlé-funded research supported deceptive "hypoallergenic" claims

Breastfeeding protects against the development of allergies.

Photo by Melanie Gillis

In 2002, Memorial University in Newfoundland was shocked by the early retirement of one of its most renowned scientists, Dr. Ranjit Chandra. For over twenty years, Chandra had made a distinguished career conducting research on nutrition and infant feeding and was considered a world-class expert in his field, but in 2000 his work began to unravel. The prestigious British Medical Journal rejected one of the studies he submitted to its editors, who believed the results had been faked.

Over the next few years, the more Chandra’s work came under scrutiny, the more suspicious his research seemed, until finally one of his research assistants came forward to say that she had never helped him conduct several of his published studies which had been paid for by Nestlé and other infant formula companies.¹ While Chandra has packed up and headed overseas, the effects of the Nestlé studies he faked will linger on, and their publication should serve as a disturbing example of conflict of interest, greed and an industry’s callous disregard for the health of thousands of infants who suffered the consequences of self-serving marketing deceptions.

Chandra’s studies^2,3 on Nestlé formula purported to prove that the company’s Good Start formula reduced the incidence of allergies in children, and justified the company’s claim that this new brand of formula was hypoallergenic – that the product could reduce atopic symptoms in infants at risk to levels similar to even better than those seen in exclusively breastfed infants. With the publication of the studies, Nestlé had a new kind of formula, a new market, and a new source of profits. Dr. Chandra got paid. Everyone was happy. But Chandra’s results just weren’t true. He never even conducted studies on Good Start formula.

The Chandra scandal reveals the inherent problems with corporate funded medical research. While there is clearly a need for companies, especially those producing food products, to improve quality and safety through generally accepted scientific research, the reality is that corporations like Nestlé are also motivated by marketing needs which do not necessarily accord with objective medical research.

For companies like Nestlé, the stakes resting on research favorable to their products are very high. When Chandra did his first study for the company in the late 1980s, Good Start was already being marketed as a hypoallergenic formula, and the company was under intense pressure from the Food and Drug Administration to verify its claims about the product. Had it not been able to find a study that proved Good Start reduced the risk of allergies in children, Nestlé would have been in serious trouble. So evidently they sought out Dr. Chandra, gave him significant funds to do research into the formula, and he returned the results Nestlé needed. It didn’t matter that Chandra’s work ran counter to the vast body of medical knowledge, which asserts that breastfeeding, rather than any formula, is the greatest factor in lowering the incidence of allergies. Nestlé had one study that said their formula could achieve similar results , and used this to gain a marketing edge.

According to UNICEF "Formula feeding is expensive and carries risks of additional illness and death, particularly where the levels of infectious disease are high and where preparation and storage of these substitutes is not carried out properly. Many studies indicate that a non-breastfed child living in disease ridden and unhygienic conditions is between six and 25 times more likely to die of diarrhoea and four times more likely to die of pneumonia than breastfed infants. A recent study of postneonatal mortality in the United States found a 25% increase in mortality when infants were not breastfed."⁵

The Chandra studies opened up a whole new market for Nestlé. His research was cited in Nestlé formula promotions all over the world and in product monographs sent to physicians and nutritionists.⁴ Never before had allergy-prone infants been so forcefully targeted by formula companies. Despite the well-known long term health benefits of breastfeeding, parents around the globe with a history of allergies were now urged to buy Nestlé’s new "break-through" formula, and thousands did. As a result, unknown numbers of babies over the past decade and a half have been unnecessarily exposed to the risks of artificial feeding.

Nestlé’s hydrolized infant formula became one of the company’s best-selling infant foods. Many more parents bought the similar products released by Nestlé’s competitors in the wake of Chandra’s bogus research. All the major formula companies aimed to increase their market shares with brands claiming to reduce the risk of allergies in children. They based these claims on corporate-funded research building on Chandra’s manufactured results.

The Nancy Olivieri Case

Although Nestlé has come under .re for decades for its unethical marketing of infant formula, the Chandra case illustrates a problem embedded in corporate-funded research that goes far beyond just one company. In 1998, a furor erupted when Nancy Olivieri, a researcher at the Hospital for Sick Children and the University of Toronto, went public with the results of a clinical trial she had conducted on a drug to treat a rare blood disease. She had discovered that deferiprone, a pill produced by the pharmaceutical company Apotex, was ineffective and potentially toxic in some patients.

Olivieri decided that she was obligated to report the findings to her institutional review board and submit them for publication in a peer-reviewed journal, but Apotex was determined to bury her research and launched a lawsuit against her, claiming she had violated a confidentiality agreement she had signed with the company. Nevertheless, Olivieri submitted her findings for publication.

At the time, Apotex was negotiating a $30 million grant to U of T and the Hospital for Sick Children. Both institutions refused to support Olivieri. Instead she was stripped of one of her positions at the hospital and publicly chastised by Sick Kids for speaking out. Finally, after a protracted legal battle, during which Olivieri alleged she was harassed for following her moral obligations, she won an undisclosed settlement from the hospital and the university in 2002.

The Olivieri case garnered worldwide recognition and serves as a stunning example of the unbalanced nature of the corporation researcher relationship. Faced with unfavourable test results, companies can use confidentiality agreements to keep critical findings from the public, rendering mute the voice of the researcher. Corporations can also use their substantial financial power to pressure institutions into protecting their corporate interests. As Olivieri’s four-year struggle illustrates, it is very difficult for relatively powerless individuals to combat such tactics.

References:

1. O’Neill-Yates C. The secret life of Ranjit Chandra. The National (Canada): (Three features). 31 January – 2 February 2006. [back]

2. Chandra R, Singh G. Shridhara G. Effect of feeding whey hydrolysate, soy and conventional cow milk formulas on incidence of atopic disease in high risk infants. Annals of Allergy 1989; 63: 102-6. [back]

3. Chandra R. Five-year follow-up of high risk infants with family history of allergy who were exclusively breastfed or fed partial whey hydrolysate, soy and conventional cow’s milk formulas. Journal of Pediatriatric Gastroenterology and Nutrition 1997; 24: 380-8. [back]

4. Carnation Good Start. Letter to Elisabeth Sterken from Steve Allen, Director, Nutritional Products Group, Carnation Good Start, a division of Nestlé. 31 October 1990. [back]

5.Obtainable at: http://www.unicef.org/nutrition/index_breastfeeding.html [back]

Formula feeding trials raise concerns

Aside from the conflicts of interest raised by corporate-funded formula trials, a larger question looms as to whether formula trials using infants are ethical.

• Research using babies could have long-lasting consequences, effectively altering infants lives well into adulthood. Trials using infants should be at best a last resort, after all other methods of testing, such as animal trials, are exhausted.

• Parents who subject their children to such trials must be made fully aware of the benefits of breastfeeding, and the risks of formula feeding, particularly of the experimental brand being tested. Parents should be supplied with full product information relating to the formula, including the ingredients used.

• Breastfeeding, and not regular formulas, must be used as the control because breastfeeding is the acknowledged best standard of practice. Often, industry-funded trials only compare the experimental formula to a regular brand. Slight differences in the new formula allow for claims that it is "better" while it fails any comparison to breastmilk.

• Parents should not be coerced into participating in trials. The request for participation should come not from their doctor or nurse, but from an outside person who is clearly partial.

WHA addresses conflict of interest

In 2005, the World Health Assembly passed a resolution to the International Code of Marketing of Breastmilk Substitutes addressing the problems associated with corporate funded infant feeding research. Resolution 58.32 urges Member States of the WHA:

"(4) to ensure that financial support and other incentives for programmes and health professionals working in infant and young-child health do not create conflicts of interests;

(5) to ensure that research on infant and young-child feeding, which may form the basis for public policies, always contains a declaration relating to conflicts of interest and is subject to independent peer review."

According to the preamble of the document, the basis of the resolution was the concern that "nutrition and health claims could be used to promote breast-milk substitutes as superior to breastfeeding." In the past few years there has been a startling rise in formula health claims - based on research funded by formula companies themselves - that assert certain brands are "better" or "reduce the risk" for certain conditions. Despite these claims, medical research overwhelmingly indicates that all formulas are inferior to breastmilk as a source of infant nutrition.

| Top | Winter 2006 Newsletters Contents |