|
Research A snapshot of federal research on food
allergy Press Release Limited federal funds spent on food allergy research means biotechnology issues are not being addressed, new report finds Washington, DC - The science needed for government regulators to assess allergies in genetically engineered foods could be greatly improved, according to a new report issued today from the Pew Initiative on Food and Biotechnology. The report, "A Snapshot of Federal Research on Food Allergy: Implications for Genetically Modified Food," found that nine federal agencies or institutes currently supervise 33 food allergy research projects totaling between $4.2 and $7 million, but that those funds are spread thin and with little coordination among federal agencies or between research teams. Moreover, the study found that the existing research focuses on known allergens such as peanuts and milk, and that almost no studies examine the allergenicity of novel proteins potentially introduced by foods created through biotechnology. In other words, the funds that have been committed to address the problem are not being strategically allocated to ensure research needs and opportunities are fully met. Food allergy is an immune-mediated disease caused by food antigens; it occurs only among people who are sensitive to those antigens. As many as 10 million Americans are estimated to have allergies to one or more foods, and for them, reactions to those foods can result in illness or even death. Little is known today about why some people have reactions to food in general. In addition, the increasing use of genetically modified (GM) crops raises several issues relevant to food allergies. On the one hand, biotechnology may help remove or change proteins that can cause allergies, but genetically modified foods could also introduce new proteins into foods that could cause allergic reactions. Without prior experience with the new protein, it is difficult for regulators to predict the potential of the protein to be a serious allergen. GM foods currently on the market have been screened for possible allergenicity problems. But some new GM foods may be difficult to judge with current science, as illustrated recently in the case of StarLink, a type of genetically modified corn that was approved for use only in animal feed because it could not be shown that the new protein in the corn was not an allergen. "Almost two years ago, Starlink accidentally made its way into the human food supply," noted Michael Rodemeyer, executive director of the Initiative. "After massive consumer product recalls, lawsuits, buybacks from farmers and a disruption to American farm export markets that continues today, we still lack answers to the basic science questions posed by government regulators whether StarLink was or was not an allergen," he said. "Was the Starlink recall even necessary for allergy reasons? We just don’t know. "Unfortunately, this lack of scientific knowledge is hindering both the government as well as the private sector -– we need to invest in the science to give regulators the tools and information they need to evaluate new products and protect the public," he concluded Drs. Lynn R. Goldman and Luca Bucchini of the Johns Hopkins Bloomberg School of Public Health conducted the study. The authors reviewed food allergy research funded by the federal government and aimed at investigating food safety. Research abstracts were sourced from CRISP (Computer Retrieval of Information on Scientific Projects), a database of research supported by the Department of Health and Human Services, and CRIS (Current Research Information System), a database supported by the US Department of Agriculture as well as additional sources. Because of the way CRISP and CRIS are maintained, the study is a snapshot in time; it captures research projects that were active in Q3 2001 and does not account for studies that may have just been completed or that will soon be approved. The study also does not include research undertaken by the private sector, NGOs or states, which all may have an impact on the advancement of food allergy research but are not easily investigated. The study did not include ongoing federal research projects that more generally investigate allergy and may, in time, produce results that contribute to understanding of food allergy. For a copy of the study, go to: http://www.pewagbiotech.org/ The Pew Initiative on Food and Biotechnology is a nonprofit, nonpartisan research project whose goal is to inform the public and policymakers on issues about genetically modified food and agricultural biotechnology, including its importance, as well as concerns about it and its regulation. It is funded by a grant from The Pew Charitable Trusts to the University of Richmond. Conclusions and Recommendations While several federal agencies contribute independently to food allergy research, it does not appear to be a priority for any of them. There were only thirty-three research projects supported by the federal government at the time this analysis was conducted, with a total research effort in the range of $4.2 to $7 million. This is a limited commitment in relation to both the research needs on this topic and to the total federal commitment to biomedical and related life science research in fiscal year 2001 of $18.2 billion (AAAS 2001). The NIH leads the way in food allergy research, with most of its effort supported by the National Institute of Allergy and Infectious Diseases (NIAID) (2). The National Center for Research Resources (NCRR) at NIH also supports a significant portion of the federal food allergy research portfolio. The FDA has a small but focused effort that aims to meet its regulatory needs. The USDA has concentrated on identification of allergens and detection methods, and the analysis of the plants that are the primary source of food allergens. The contributions by other agencies are very small. Thus, the research is spread out among many federal agencies, with little or no coordination among them. On the whole, agencies have not developed specific research goals or objectives for food allergy. Where priorities have been articulated, as at NIAID, the work funded does not fully address the priorities identified. While some of the projects recognized in this analysis are relevant to the regulatory assessment of new biotechnology products, the sum total of the effort is not adequate to improve sound, science-based regulatory decisions on potential allergenicity. The multifaceted nature of food allergy is probably best addressed by a combination of efforts both on basic research questions and targeted activities to develop needed regulatory assessment tools. The findings of this study demonstrate the value of research funded by the USDA and the FDA to address regulatory needs while NIH supports advances in the understanding of food allergy that forms the basis of safety assessments. However, this report clearly shows that the current funding level at all agencies is insufficient and there is a role for stronger coordination of activities across agencies. Therefore, we recommend that a process be initiated to develop a coordinated federal food allergy research agenda that clarifies near-term scientific goals, the funding level needed to achieve such goals, and the role of each federal agency in supporting such work. Specifically, we recommend: 1. The development of a comprehensive assessment of current research needs and opportunities, with a particular focus on regulatory needs, with the input of scientists and key agencies. 2. The use of this assessment to develop broad goals and specific near-term research priorities. Goals may include: generating valid scientific information to develop effective and protective regulation of potential new allergens; determining the cause of food allergy and developing interventions to prevent its initial occurrence; reducing the burden of food allergy for people with the disease; preventing anaphylactic episodes and mortality from anaphylaxis; assessing the burden of food allergy in subpopulations; and tracking the disease and assessing the effectiveness of food allergy programs. 3. The development of shared goals and strategies among federal agencies that assign specific objectives to each agency. Designate a lead agency and encourage the involvement of private and non-profit parties wherever possible. Cooperation could achieve an optimum whereby research would be useful both for the scientific and public health communities. 4. A determination be made of the funding levels needed to achieve the stated research priorities in a specified period of time and a commitment made of the appropriate level of funds each year until the goals are achieved. When agricultural biotechnology moved from the laboratory into the field and then to the marketplace, policymakers and the public challenged food allergy scientists to answer new questions and apply what they knew to novel situations. All of the participants in this debate, whether scientists, policy makers, the public, or biotechnology developers, have a stake in the development of the necessary information to ensure that regulators are making sound, predictable regulatory decisions. Current advances in biomedical and public health research offer a tremendous opportunity to meet the scientific challenges raised by biotechnology in relation to food allergy. A coordinated and focused effort by federal agencies to support the science needed to resolve these questions would pay large dividends to all stakeholders- including helping to avoid the kinds of economic losses and negative impact on public trust seen with StarLink corn. |
