Interview Transcript

Roundtable Discussion with  William Keye, MD,  Hind Hatoum, PhD and Scott Chappel, PhD

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Dr. William Keye: I’m Dr. William Keye and we would like to discuss some of the issues that came up during the presentation section we have just seen. I have Dr. Scott Chappel and Dr. Hind Hatoum with me, each of whom you have heard in the previous discussions. Dr. Hatoum, what do you think the take-home message is today for the audience?

Dr. Hind Hatoum: I think the biggest issue is the use of clinical trial findings to come up with an economic program. The advantage of using the clinical trial data is that you are using what actually happened, even under ideal circumstances, but at least it comes as close to what should be happening and taking that information and come up with an economic argument. The advantage is that when you try to take it to the larger community, a presentation of the information, the sample size becomes an issue, what the study shows. Whatever we come up with would have been verified if the sample size was much larger. It is not different for any other indication I work on, versus that which you see with infertility. That is the biggest issue, so if I have a chance to go back and I have more time to talk about how intricate the process is, then I would have been able to say that these are the circumstances under which the trials were conducted. If these circumstances were different, then maybe the outcome would be different, but I am following the same model that the FDA used to grant approval for an agent and for that I cannot be apologetic. This is what we found and this is what we used to do the model. Under different circumstances, it is an evolving process. It is a work in progress, if you will.

Dr. William Keye: Thank you. Dr. Chappel?

Dr. Scott Chappel: I think it was an interesting mix of presentations today, talking about pharmacal economics, the clinical perspectives, those basic science perspectives, and the take-home message that I took was that it is a complicated area and really requires the ultimate decision of the practicing physician to make a decision of what is the best type of clinical program to provide for his or her patient. I think that today’s discussion opened up the idea that in terms of efficacy, safety and consistency, as well as pharmacal economics and patient outcome, there are plenty of choices and it definitely requires an informed decision to be made.

Dr. William Keye: I think the message that I took home was that there are a number of gonadotropin products on the market and they are recently equivalent in their clinical efficacy and safety. It is advantageous to the clinician to have a variety of products because each patient is unique and they require their own specialized or personalized protocol and the opportunity to mix medications in different combinations at different stages of the stimulation protocol are sometimes advantageous to specific patients. When it comes down to it, despite all the randomized clinical trials and studies that we do, it is still the clinical judgment of the clinician and the specific desires of the patient that win out in the end.