More than 33 million Americans have life-threatening allergies to food allergens, including nuts, shellfish, eggs or dozens of other common foods. That translates to about one in 13 children and one in 10 adults. Many of these experience severe food allergic reactions or even anaphylaxis, resulting in 3.4 million people in the United States seeking emergency care yearly to treat an allergic reaction to food.
Despite this growing problem, people with life-threatening food allergies have few options. Even more troubling is the effect of racial and ethnic disparities in patients with allergic diseases, where it is estimated that Black and Hispanic children have higher rates of food allergy. African-American children have a 40 percent higher risk of food allergy, and Hispanic children have a 20 percent higher risk than non-Hispanic White children.
This information is not new to food allergy sufferers who understand that supporting transformative food allergy innovations and programs is critically important. Overcoming the significant barriers and challenges of health disparities and addressing the innovation drought in food allergy will require a concerted effort by patients, health providers, local agencies, professional societies and policymakers. Treatment and prevention of the disease must be a priority for researchers. And one important step in that process is through clinical trial diversity to ensure that everyone can benefit from the scientific innovation that addresses disparities.
Clinical trials are the key to transformative research and innovation. Before the FDA approves an experimental treatment, extensive clinical trials — averaging 12 years of research and development — are conducted to prove the product’s safety and efficacy, and determine the proper dosage and uncover any side effects. It’s critically important to have populations most in need of the studied drug represented in the clinical trials.
In food allergen immunotherapy clinical trials for which racial and ethnic demographics were reported, only 4 percent of trial participants were African- American or Hispanic. It is imperative that future clinical trials reflect the patient population that will actually benefit from treatments, remembering that clinical trial diversity means little if the resulting products are unaffordable or unattainable.
Non-profit organizations such as Food Allergy Research & Education are making considerable strides in fostering diversity, including in clinical trials and innovation. The organization is also working to increase the racial and ethnic diversity represented in the FARE Patient Registry and to support food allergy education and training within the FARE Clinical Network and the Diversity Scholars Program, attracting future medical and public health professionals from underrepresented populations.
One organization’s efforts are not enough. Innovation is vital, and partners like the government, bio-pharmaceutical companies and others are pivotal players in finding solutions. Political leaders at the federal level must continue to foster a policy environment that promotes more research and development into food allergy treatments and cures and helps support increased funding and policies that lead to further innovation for all members of the food allergy community.
For the millions of families caring for loved ones with food allergies, the need for options, innovation and treatment is paramount. Living with food allergies is not merely an inconvenience — it is a life-altering, life-threatening, daily struggle, costing food allergy families $25 billion annually.
While revolutionary advancements have been made in other disease fields, such as cancer and diabetes, there remains only one FDA-approved treatment for food allergies focused solely on peanut-allergic children ages 4-17. Food allergy sufferers require additional treatment options. And they deserve the same attention to diversity, access, funding and innovation as other disease categories.
The need and hope for research and development breakthroughs are critical to change lives, providing hope and reducing mortality rates. Along with caring partners supporting the development of new food allergy treatments, the fight is on to transform the lives of those with food allergies and one day find a cure.