Testimony of Dr. Margaret Dayhoff-Brannigan
FDA Advisory Committee meeting on Allergy Products
My name is Dr. Margaret Dayhoff-Brannigan and I am the Patient Advocacy Project Manager at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.
Thank you for the opportunity to speak here today.
I completed my Ph.D. in Biochemistry and Molecular Biology at the Johns Hopkins School of Public Health. In addition, my three-year-old has life-threatening food allergies and was recently started on inhaled steroids to treat asthma symptoms. I bring the perspectives of both a researcher and parent here today.
My husband and I do not have any food allergies, so we were shocked when blood tests for our then one-year-old came back with an extremely high level peanut allergy. The pediatrician called us personally with the results and to tell us to go to an allergist immediately to get an EpiPen. After making an appointment, I proceeded to scour the internet for any available research on food allergies. Unfortunately, I met the same frustrations that many in the food allergy community find; there were no good answers.
Many small trials are being conducted to treat peanut allergies, and have very promising results, but they do not have long-term results. Peanut allergies tend to be life-long, so it is important to know if the treatment works for more than a few months. It is also critical to know if patients develop allergies to other foods they are not being treated for. None of these trials discuss what happens to the children that fail to develop tolerance to peanuts after treatment. These children need to be followed to see if their sensitivity to peanuts is now more severe, and if they have other immune problems.
Due to the nature of these treatments, parents may be tempted to try these remedies at home. So many people who saw these “cures” in reports on the news asked if I had tried feeding my child small amounts of peanuts to cure his allergy. We must be clear to everyone, not only allergy sufferers, that these treatments are only to be tried with careful medical supervision.
It is critical that the appropriate studies be performed to get a better understanding of these treatments. Ideally clinical trials would include the following:
- Large sample sizes that are representative of the ethnic makeup of allergy sufferers and be double-blind and placebo controlled. Subgroup analyses should be conducted to make sure the treatments are safe and effective for each group.
- Conducted on children representing a range of ages. Metabolism rates vary significantly in children depending on age, so doses for 2-year-olds would be very different than for a 10-year-old. Subgroup analyses are again needed, this time for the different age groups.
- A long period of follow-up evaluations. Including data for the allergen being tested, as well as the development of other potentially relevant immune responses, such as food allergies, seasonal allergies or asthma.
- There should also be follow-up studies on the patients that “fail” treatment, to determine if their allergic conditions worsen as a result of a sensitizing event. Follow up should also include patients who withdrawal from a trial voluntarily due to their inability to tolerate the treatment.
It is important that these treatment options be tested under careful supervision of trained medical professionals due to the risk of adverse events. All of these treatments carry significant risks which need to be better understood.
There have been promising new studies on prevention of allergy, especially the LEAP study. This study shows that early peanut exposure in children at risk might prevent allergy. Unfortunately these trials only look at children up to 5 years of age, so it is still unknown if the children will develop allergies later in life. Or if they develop serious allergies to other foods, such as shellfish or tree nuts.
Unfortunately, updating the standards to encourage parents to feed at-risk children peanut products early in life presents a certain amount of risk. There are already reports of children having severe reactions despite negative skin prick tests. We must be cautious about the application of these new standards, and we must continue to study the long-term ability to prevent allergy and other allergic disease.
In addition, these promising studies need to be supplemented with treatment options for children and adults who are already allergic, and the children for whom prevention does not work.
Allergies can be a life-and-death situation. Approximately 100 people die each year from anaphylaxis due to food allergies. Treatment options for food allergies could save lives, significantly improve quality of life for many families, and reduce the number of severe reactions from occurring. The increase in food allergy prevalence is an important public health problem. We must require that clinical trials study all of the necessary variables to help families make informed treatment choices.
I really hope that the treatment options continue to look promising. Better clinical trial data will help families make important decisions about the risks and benefits of treatment.
As a researcher, public health advocate, and mother, I thank you for your consideration of these important research design issues.