Letters to the Editor

Cycle of Seeking, Emotional Outburst, and Rest in Newborns Put to the Breast

Concerns Regarding Industry-Funded Trials

Over the past year, I have become increasingly concerned about the response of many lactation consultants to industry-funded clinical trials. While I realize that this issue was the subject of a recent JHL editorial,1 the purpose of this letter is to clarify and expand upon this subject within the context of three major points: 1) New lactation products and techniques are necessary as breastfeeding initiation and duration rates increase, because more complicated lactation scenarios will present themselves; 2) it is the role of industry—not the taxpayer—to incur the cost and risk of developing these products; and 3) prior to introduction into the clinical arena, these products and techniques are subjected to normal research trials by competent, experienced lactation investigators. I will illustrate each of these points with examples and citations, as appropriate.

New Lactation Products andTechniques Are Necessary

The combined efforts of human milk researchers, practitioners, educators, and policy-makers have been successful in targeting groups of women who previously would not have considered breastfeeding. Many of these mothers experience breastfeeding risk factors is increased in those with prolonged breast feeds (P = .01) and problems that can compromise successful lactation, such as extremely premature birth, severely delayed lactogenesis, low milk volume, or early return to the workplace. Management of these situations requires lactation products and techniques that can serve as temporary aides until underlying problems can be diagnosed and treated. Thesei nterventions include the use of breast pumps, creamatocrit measures of milk fat and calories, hindmilk feeding, nipple shields, infant test weights, and metoclopramide augmentation of milk volume. Some in the lactation community condemn these strategies as unnecessarily medicalizing breastfeeding. However, for those of us who work primarily with at-risk populations of women and infants, these interventions are lifelines that sustain breastfeeding under the most unnatural of circumstances. It is critical that these products and techniques are comfortable, effective, and acceptable to mothers and infants who use them.

Historically, in the lactation field, we have relied upon inexpensive or poorly conducted informal studies and anecdotal product evaluations—often accompanied by testimonials from clinical lactation experts—to communicate information about breastfeeding products. However, as we work to standardize lactation practices and secure third-party reimbursement for our services, we must begin to insist on evidence-based products and technologies. The only way that this information is acquired is through well-designed, rigorous clinical
research trials, as is the standard in all other health care disciplines.

Industry Versus Taxpayer Funding of Clinical
Research Trials

The next basic question is, “Who should fund these clinical research trials?” In a recent publication2 I and my colleagues raised the question as to whether federal funding for breastfeeding research from 1994 to 1997 was targeted toward achievement of our national health objectives. We found that only 1.7% of federallyfunded projects, representing just 3.9% of the available (US)$40.4 million, focused directly on initiation and duration of breastfeeding. While most of this budget was spent on basic science research, 10.2% of monies, that is, (US)$4.1 million, were directed toward using human milk properties and technologies to develop products that benefit private industries—such as improved infant formulas and other pharmaceuticals. In that paper, we questioned the ethics of using taxpayer monies to develop products and technologies that ultimately provide profits for private industry—especiallywhen barriers to achievement of our national health objectives go unstudied. The analogy with lactation products and technologies is identical. Private industry—not the federal government through taxpayer monies—should support the research and development of breastfeeding-related products. These industries should incur the costs and risks involved in the developing and testing the new products, with the potential for profit if they are subsequently demonstrated to be safe, effective, and acceptable to consumers. As professionals, we should insist that all new products and technologies are based on well-designed clinical trials. Similarly, it is imperative that barriers not be put in place to the dissemination of findings from these studies. Publication and presentation of well-designed clinical trials that focus on a lactation product should not be subjected to a reviewer bias that equates this dissemination as free advertising. This censorship implies that lactation professionals are unable to distinguish between product reporting and product promotion. Disclosure of industry sponsorship, peer review, and reader scrutiny are the standards used by other professions to optimize objectivity in this regard.

Who Should Conduct the Clinical Research Trials?

Reputable, experienced lactation scientists have typically conducted research trials that are funded from three primary sources: federal monies (eg, National Institutes of Health or Centers for Disease Control), private foundations or not-for-profit organizations (eg, ILCA, March of Dimes, National Association of Neonatal Nurses), and industry. Often, an investigator may have monies from all three sources simultaneously, and the actual studies may overlap in some areas. To assume that these investigators are uniformly biased or notobjective because some of their research is directed toward testing breastfeeding products or technologies probably reflects a lack of understanding of the nature of this work.

The ethical oversight of lactation research is no different than the provision of ethical breastfeeding services. In each case the professional’s reputation among colleagues and consumers depends upon work that is performed ethically. For the researcher, a breach means that further nonindustry monies may be withheld or that one is no longer competitive in securing external funds for subsequent studies. Industry cannot buy the objec-tivity of a reputable, experienced human milk scientist any more than it can buy the services of a dedicated practitioner.

Several safeguards at the institutional level help to insure that industry-funded studies are conducted ethically, as well. First, the lactation scientist agrees that a product or technology has potential utility and works with industry to design an objective trial that tests measurable outcomes. Contracts that specify the work to be
done are signed by institutional officials and industry executives only after the studies are approved by human subjects review boards. Experienced investigators are careful to negotiate within the contract that the data are owned by the institution rather than by industry. This means that findings can be disseminated through publications and presentations, regardless of whether the product performs in a manner anticipated by its industry sponsors. Finally, the source of all funds is disclosed when the investigator presents or publishes the industry-sponsored study. In summary, instead of condemning industry-funded studies, lactation professionals should insist that all products finding their way into clinical practice be subjected to clinical research trials prior to widespread application. This move represents the elevation of lactation practice to professional status and is a step toward national recognition and third-party reimbursement. I would argue that funding of these trials is the responsibility of industry and not the taxpayers or philanthropic foundations through federal or not-for-profit monies. The studies should be performed by senior experienced lactation scientists who are capable of negotiating data ownership and other ethical considerations with industry sponsors. Finally, disclosure—rather than barriers to dissemination of industry-funded findings—should serve as the standard for publication and presentation, as is the case with other professional groups.

References
1. Heinig MJ. The “price” of information. J Hum Lact. 2003;19:133-135.
2. Brown LP, Bair A, Meier PP. Does federal funding for breastfeeding research
target our national health objectives? Pediatrics. 2003;111: e360-
e364.

Paula Meier, RN, DNSc, FAAN
Director for Clinical Research and Lactation, Special
Care Nursery, Rush University Medical Center
Dr. Meier receives or has received research funds
from National Institutes of Health; Association of
Women’s Health and Neonatal Nursing; National Association
of Neonatal Nurses; American Nurses’Foundation;
Rush University College of Medicine; Olympic
Medical, Inc.; Medela, Inc; and Separation Technology.

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