The Cost of Bringing Research Discoveries to Life

By Jessica Martin, PhD

Making scientific discoveries and then translating those discoveries into treatments for food allergies takes money—on the scale of hundreds of millions of dollars. Yet, if we consider that food allergies are currently estimated to cost U.S. families around $25 billion annually, the investment in a cure would, in time, more than pay for this enormous burden.

This figure reflects the dramatic increase in the number of Americans, especially children, who have food allergies, which has occurred within a very short period—about 15 years. Before then, little research was being conducted, and few scientists chose food allergy as a career. As a result, the research community, industry and advocates are now racing to develop the financial and scientific resources that will lead to new treatments and, ultimately, a cure.

Federal funding plays a crucial role—but not the only role—in this equation. The government-funded National Institutes of Health (NIH) has increased its investment in food allergy research, from $4 million in 2004 to some $36 million in 2013. FARE has advocated for federal funding that is commensurate with the magnitude of the problem, and will continue to call for significant increases. However, faced with the uncertainty that comes with federal funding and the need to allocate its nearly $30 billion annual budget among dozens of life-threatening and life-altering diseases, the NIH must work in partnership with other sources to advance research into food allergies, as well as other conditions.

All of us can be powerful advocates for research, but to do this we need an understanding of how research works. I recently asked a question of my cell biology students: “From the following options, rank in order (from most money to least), where you think funding for biomedical research performed in a university setting in the U.S. comes from: 1) the university, 2) the federal government, 3) industry (e.g. pharmaceutical or biotechnology companies), and 4) nonprofit or philanthropic foundations (e.g. FARE).” What would your answer be?

In reality, the answer depends on the type of research conducted. Research broadly falls into a pipeline of three categories, with each stage of the pipeline feeding the next: basic science, translational science and clinical research. Each category has its own challenges.

Basic science
Typically conducted in a university setting, basic science research answers questions key to biological function, such as how the immune system functions in health and illness. The pace of discovery is “steady, but measured, with unpredicted and sometimes serendipitous discoveries that have enormous impact,” according to the American Society for Biochemistry and Molecular Biology. One example is the discovery of the structure of antibodies in the early 1960s. Not only was this finding pivotal to discovering that allergy results from misdirected IgE antibodies, but it also set off a cascade of breakthroughs well beyond immunology. Across many scientific disciplines, antibodies are used as research tools to identify or target specific proteins of interest.

Challenges: As mentioned earlier, the NIH, the largest funder of basic science research, has recently seen unpredictable yearly budgets due to the difficult economy. If the 2015 federal appropriations bill becomes law, the NIH would receive a modest increase. While this would alleviate the impact of 2013 budget cuts, the agency still would have fewer funds available than it did in 2010. Individual research labs at universities rely on competitive grants from NIH to keep experiments running. Solid, predictable funding of basic science research feeds discoveries that make it downstream in the research pipeline—and that ultimately may reach the patient.

Translational science
Translational science’s goal is to “translate” basic science discovery into clinical use. To follow the earlier example, based on knowledge of the IgE antibody’s role in allergy, many researchers hypothesized that neutralizing IgE antibodies could treat allergic disorders. In the early 1990s, scientists at Genentech published their work in developing anti-IgE therapy—the medication we know today as omalizumab (Xolair®)—thus paving the way for clinical trials to treat allergic disorders.

Challenges: Traditionally, this category sees less NIH funding and greater investments from other sources, primarily industry and nonprofit organizations. Promising basic science discoveries may never get picked up by potential funders, either because they do
not come to their attention or are deemed too risky.

Clinical research
Clinical research includes many broad goals, such as uncovering mechanisms of human disease and clinical trials for treatments. All, however, involve human subjects or tissues. By the late 1990s, clinical trials began testing the safety and efficacy of omalizumab for allergic asthma. Based on the outcome of multiple trials, the FDA approved omalizumab for this indication. Currently, researchers are combining omalizumab with oral immunotherapy (OIT) as a potential treatment for food allergy. FARE is funding
many of these clinical trials.

Challenges: Clinical research studies are usually much more costly than studies earlier in the pipeline. A variety of sources pick up the tab, including government sources. The biggest contributor by far, however, is industry. But money is not the only resource that clinical research lacks—often studies lack participants. As Dr. Scott Sicherer, a prominent food allergy researcher and member of FARE’s Medical Advisory Board, often tells his patients, “we could do more with two things: more funding and more people participating in research studies.”

FARE’s role
A common misconception is that the biggest funding source is the most effective at producing results. According to the latest industry profile from the Pharmaceutical Research and Manufacturers of America, it can take more than $1 billion to bring a new drug to market—but the millions that FARE spends on early-stage clinical trials can mean the difference between developing a promising therapy or allowing it to stagnate. Every dollar spent is highly strategic. In fact, FARE—modeling itself upon pioneering disease nonprofits that have demonstrated success—plays a central role in ensuring that research moves rapidly
down the pipeline.

As part of its comprehensive strategic plan, FARE has adopted a “hub and spokes” model where FARE is the hub and organizes the various “spokes”—researchers, key monetary players, and possible study participants—toward common goals. What this means is that FARE is advocating for more government-funded research for basic science and is providing seed money to gifted investigators, enabling them to generate enough data to qualify for large, NIH-funded grants for all levels of research. FARE is funding studies to help bridge the gap in translational research. FARE is actively investing money in clinical trials, and organizing researchers toward common study procedures to expedite treatment approvals, and so much more. Simply put, FARE is the catalyst for progress in food allergy research.

How You Can Help
FARE is a “hub” connecting all of us living with food allergies toward our hope of a cure, and all of us can help.

  1. Understand the details of FARE’s research strategy.
  2. Invest money in FARE to make the strategy a reality.
  3. Lobby Congress to stabilize government-funded research budgets. FARE’s advocacy tools can help.
  4. Consider participating in clinical trials.

jessicamartinJessica Martin teaches undergraduate courses in general biology, cell biology, and anatomy and physiology at Portland Community College. Jessica educates on the science behind food allergies on her blog, the Food Allergy Sleuth, as well as multiple social media platforms. She is the mother of two young boys, one of whom has multiple life-threatening food allergies.

This article was originally published in the Summer 2014 issue of FARE’s Food Allergy News. Read more of the newsletter here.