This is the e-mail I sent to the Principle Investigator and the other doctors and staff involved in the PRROTECT study at Lurie. I am sharing it because it lays out our thought process and next steps clearly, and I know many people who have followed Susan's journey are interested in knowing what our plan is. This morning, Susan joked that we will call this "Eating Peanut, Phase 2." And...perhaps we will.
As Susan’s completion date for the clinical trial draws near, I wanted to write to thank you, Dr. R. and Dr. M – as well as (...) and (...) and the various other clinical trial coordinators we knew along the way – for all you have done to support Susan during the clinical trial. While I know Susan did not achieve the level of peanut tolerance anticipated, we are thankful beyond words that she achieved the tolerance she did.
As you know, we have been very concerned about Susan’s occasional inability to tolerate her daily dose of 2000 mg of peanut protein, as we wonder what that means when it comes to protection against casual exposure and/or cross-contamination. Susan’s seemingly random anaphylactic reactions also leave us constantly just a bit on edge, always slightly uncertain about how she will tolerate her daily dose. While I understand that with more than seven months of daily dosing at 2000 mg of peanut protein Susan should be able to consistently tolerate her daily dose, as you know, that has not been the case. Clearly, Susan’s journey toward tolerance of peanut has been atypical, and we hope that her commitment to the clinical trial proves beneficial to others.
Since our last clinical trial visit, I have done extensive research and have spoken with a number of different people in the food allergy community (researchers, doctors and parents). As you know, despite (or maybe because of) how difficult the journey has been, Susan is very clear that she wants to continue eating peanut. While she is open to the idea of decreasing her daily dose in the short term, in the long term, she wants to be able to eat enough peanut daily that she does not have to worry about miniscule variances in her daily dose causing anaphylaxis. While Susan appreciates the freedoms she is likely to have as the result of the clinical trial (she has already, for example, been to several movies in the theater and we are talking about taking a short flight), she wants greater freedom.
I have become convinced that if Susan is to achieve long-term true tolerance of peanut, we need to take a step back, to look at things differently. I am interested, for example, in looking at Susan’s gut health. I am concerned that some of the very medications added early in the clinical trial (to support her tolerance of peanut) might be interfering with her absorption of peanut. I also believed the addition of probiotics might make a difference in Susan’s ability to tolerate peanut. Recently, I have read some very interesting things about the importance of Vitamin D in the diets of children with severe food allergies. While I do not know if the answer for Susan is as simple as any of the above ideas, I feel that we must at least try things differently.
After extensive research and discussion, we have decided to work with Dr. Sakina Bajowala, at Kaneland Allergy. I understand that there are a lot of concerns about oral immunotherapy offered in a private practice setting, and some of those concerns are what led us to initially pursue treatment in a clinical trial for Susan. That said, as the clinical trial draws to a close for Susan, we have become increasingly interested in pursuing a highly personalized treatment for Susan. I have come to believe that the best way to get a specialized treatment approach is in a private practice setting with a doctor who has extensive experience in oral immunotherapy.
We appreciated your approval of and Dr. R.'s willingness to co-follow Susan with Dr. M. (Susan's primary allergist), and want you to know that our decision is based on what we hope Dr. Bajowala can offer Susan. I remain hopeful that Susan’s journey – while clearly outside the expected norm – is helpful for others, for surely there are others like Susan. If you, or Dr. R., would like to co-follow Susan during her post-clinical trial care and treatment with Dr. Bajowala, she is amenable to that, and we would welcome the continuity of care.
Thank you again – while our clinical trial experience was more difficult than I ever could have anticipated, we now know the depth of Susan’s strength and the strength of her commitment. Thank you for giving her (and us) hope.