Photo by Rebecca Gould Photography

Thursday, July 2, 2015

What I Wrote (or My Missive)

Dear Dr. P., Dr. M., Dr. R., & Dr. Bajowala,

We are writing to you because we are hoping you will agree to something we know is highly unusual.  We would like one of the doctors from PRROTECT to co-follow Susan during her post-clinical trial care with Dr. Bajowala.  I raised this concept previously, but wanted to write directly to explain why it is important to us.

While our most compelling reasons for wanting Susan to be co-followed by one of the doctors from PRROTECT and Dr. Bajowala once the clinical trial is over do not pertain directly to her, we do believe it would be in Susan’s best interest – as a patient and as a child.  Continuity of care and maintenance of the relationships Susan developed with doctors during the clinical trial is important for Susan, as she has consistently demonstrated a strong commitment to research in the food allergy field.  If she is co-followed, Susan will experience that same commitment from the doctors who have overseen the clinical trial since the beginning while undergoing the more specialized treatment options we are hoping Dr. Bajowala can offer.  As Susan’s mother, I feel strongly that it is important that she feels supported in her post-clinical trial care plan, even if it is unusual.

In the past eighteen months, I have come to understand that there is a long-standing history of subtle (or maybe, in some cases, not-so-subtle) tension between pediatric allergists in the field of food allergy research/clinical trials and pediatric allergists offering treatment for food allergies in private practice.  I have also learned there are many people within the food allergy community who believe there is only one “right” way to address the growing food allergy crisis.  Susan’s experience in the clinical trial over the last eighteen months has underscored what we already believed to be true:  the “new” real world allergy patient is unique.  Every patient needs something different, and for many of those patients, a truly meaningful, quality-of-life-improving treatment is only likely to be achieved with the wisdom of more than one doctor. 

If Dr. Bajowala and a doctor from PRROTECT work together to treat Susan once she finishes the clinical trial, it will send a powerful message to the food allergy community that ultimately the “food allergy cure” is not the same for every patient.  While I am an accidental blogger, I have come to understand the importance of sharing Susan’s story, as people everywhere need to understand the realities of these early food-allergy treatment efforts.  Many people in the food allergy community have followed Susan’s journey, and are waiting to see what happens next.  Working together, we could become an incredible example.

Working together to find the very best treatment approach for Susan would be a significant and remarkable leadership step, as co-following Susan would demonstrate the possibility of forging a very important relationship between those who do research and those who implement in practice the research that has been done.  We also believe that for those parents who hesitate to allow their child to participate in a clinical trial because they worry about post-clinical trial care, demonstrating clearly this type of post-clinical trial commitment is very important, and feel that it might make participation in clinical trials more appealing.  We also believe that if both doctors work together, the formation of such a treatment team for Susan would directly challenge the belief held by some parents of children with food allergies that researchers are not invested in the long-term well-being of their subjects.  (While I do not believe this to be true, I have heard it often enough to know there is a significant percentage of the population that does).

In addition to the benefits Susan would derive from being co-followed, and the benefits to the food allergy community as a whole, the doctor from PRROTECT and Dr. Bajowala would likely derive benefits for their own practices.  As a social worker, I firmly believe that I can always learn from other skilled clinicians, and I believe the same is true in the medical field.  We are confident that if you agree to work together, and to co-follow Susan, you will both benefit from exchange of information you can use to inform your own practices.

We think everyone involved will agree that Susan did not respond to the treatment provided in the clinical trial as anticipated.  While there are a number of theories as to why Susan did not respond as anticipated, we do not yet understand why she did not achieve the desired tolerance of peanut protein.  We believe that under Dr. Bajowala’s care, with treatment tailored specifically to Susan, we are likely to gain a better understanding of why Susan struggled to achieve the desired tolerance of peanut protein.  While we know Susan falls outside the “norm” in terms of her response to the treatment provided in the clinical trial, we are increasingly certain that Susan is not the only child who has not responded as expected in a clinical trial.  Children like Susan, who do not respond as anticipated are of tremendous concern for us, for the key to their food allergy treatment is clearly not yet fully understood.  We are hopeful that Susan’s response to an individually tailored treatment plan with Dr. Bajowala will provide insights that will be beneficial in the treatment of other children like her, and we expect that treatment implications generalizable to others like Susan will emerge.

We see the unexpected week in which Susan is still in the clinical trial as an opportunity to work out whatever details we need to in order for this to work for everyone, including a communication plan and method for sharing of medical records.  When we met with Dr. Bajowala in early June, she was already somewhat familiar with Susan’s experiences in the clinical trial.  Dr. Bajowala also reviewed Susan’s course in the clinical trial with us in great detail.  She was highly complimentary of the PRROTECT doctors’ efforts to keep Susan in the clinical trial by addressing symptoms during Susan’s early dosing with medication.  She noted how committed everyone was to Susan despite Susan’s difficulties during the clinical trial, and Dr. Bajowala agreed with the concern we think we all share, which is that Susan does not consistently and reliably tolerate her daily peanut dose. 

While I invite you to talk with Dr. Bajowala directly (and I will sign whatever release or consent needed), I feel that I can accurately summarize her initial treatment plan.  She recommended reducing Susan’s daily peanut dose, adding probiotics and Vitamin D and slowly weaning Susan off of the Omeprazole and then the Famotidine.  Dr. Bajowala expressed her belief that with time, Susan could increase her daily peanut dose, but we agreed to address increased peanut dosing once we see how Susan does with the initial treatment plan.  I believe that a reduction in Susan’s daily peanut dose is a recommendation everyone will be comfortable with.

Once Susan, Paul and I met with Dr. Bajowala, our decision to ask Dr. Bajowala to treat Susan after the clinical trial was easy, because she has extensive experience with oral immunotherapy and she had some concrete ideas about how to improve Susan’s tolerance of her daily peanut dose.  While the best choice for Susan was clear, it was a hard decision to make, because we do not want to lose our relationship with the doctors from PRROTECT, and we never want anyone to feel that we think treatment in a private practice setting is preferable to participation in a clinical trial.  While the best course for Susan was clear, concerns about how our decision would be viewed by others – and about the message it might send to the food allergy community – gave us pause.  When I explained to Susan yesterday that I intended to write this letter, asking Dr. Bajowala and a doctor from PRROTECT to co-follow her, she was really pleased.  I asked her what I should say, and she summed it up well: “I think this would be a great learning opportunity for everyone.”

We think we understand the significance of what we are asking, and we thank you for your consideration of our request.  Should you agree to work together, we promise to do all that we can to make the collaboration easy, and if for some reason co-following Susan does not work, we will chose a single doctor promptly.  We are deeply hopeful that we can find a way to make it work for both Dr. Bajowala and one of the PRROTECT doctors to co-follow Susan.  While we know our request is unusual, we believe we all want the same thing – fewer children living with the risks and limitations imposed by food allergies.  Thank you so much for all you have done already – and for all we hope you will be able to do—for Susan, and for countless others like her.


Caryn, Paul & Susan 

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