RICHARD PAZDUR and ELLEN GOODMAN were honored by the National Coalition for Cancer Survivorship for their contributions to cancer care at the “Focus on the Care” reception Oct. 21 in Washington, D.C.
Pazdur is the director of the FDA Office of Hematology and Oncology Products, and Goodman is a Pulitzer Prize-winning columnist, author and the founder of The Conversation Project, a national public health campaign focused on end-of-life care.
Goodman received the inaugural Jessie Gruman Award for Patient Engagement, established with a grant from the Center for Advancing Health.
Pazdur received the NCCS Public Service Leadership Award in recognition of his research and leadership at the FDA as well as his career in developing oncology drugs for over 30 years.
“Rick was in the trenches doing the hard work,” said Robert Califf, FDA deputy commissioner for medical products and tobacco, during the reception. “The willingness to establish order and try new things in this environment is not the easiest; I have a lot of admiration for that.
“An amazing balance has to be struck between different people and opportunity or new therapies, but also protecting them when things are not right. I think Rick has set an example there,” said Califf, who was nominated by President Barack Obama to serve as the next commissioner of the FDA, pending Senate confirmation.
“I think it’s hard for people to appreciate the work of a clinician dealing with these things night and day as [Pazdur] did, now, not just working with drugs, biologics, immunotherapies, but also diagnostics, and how that fits together. But through all this technology, he’s always got the patient at the front, setting an example for everyone at the FDA.
“Some of you might be aware that in the medical world, there’s this cardiology-oncology thing that goes on, but I’ve been asking him, ‘Rick, can you replicate what you’ve done in oncology in other fields?’ He keeps saying, ‘I’m interested in oncology.’ And his route, that I’m really in awe of, is having an amazing group of people.
“Attracting people to work at the FDA is not the easiest thing in the world. The hiring system of the federal government is not necessarily the most facile to work with, but I think it’s fair to say that he’s put together the nation’s leading academic oncology group at the FDA.”
Pazdur said he did not plan on becoming an oncologist.
“Let me just start off with this oncologycardiology ‘thing’ that Rob referred to,” Pazdur said. “I don’t think most know this, but early on in my career, I was going to become a cardiologist. I took an oncology rotation late in my internal medicine training and I fell in love with the field. So, it’s cardiology’s loss, oncology’s gain. For me, oncology is a more fascinating field.”
FDA’s standards for regulating oncologic agents have been successful because OHOP invests in the professional growth of its personnel, Pazdur said. “We have an amazing group of people who don’t get lost in the weeds or minutia,” Pazdur said.
“We’re focusing on big picture issues, we have camaraderie, and I hope, as a leader, I focus on every individual’s career.
“I take a look at all of the review staff and many are in their 30s or early 40s—they are ‘All My Children.’ I attempt to develop their careers, and I want everyone—all of the physicians, basic scientists and support staff—to feel fulfilled and to feel their careers are being developed and built.
“I would like our staff to understand that I am for them. I have their best interest in mind. It’s not about me—I don’t need to give another talk, I don’t need to get another award, I don’t need to write another paper—it’s about you, our FDA staff, and developing your careers.”
Clinical trials and regulatory processes must be centered on the patient experience, which evolves over time, Pazdur said.
“The next thing I want to mention is ‘the patient voice,’” Pazdur said. “What is the patient voice? I don’t think there is a thing such as the patient voice. It is a collection—a chorus of many voices, of many different experiences—that may change during the course of an illness.
“For example, the way a patient looks at a clinical trial or treatment options when they are undergoing adjuvant therapy may be very different from a patient who has progressed through multiple therapies and may have few therapeutic options. Hence, the risk-benefit evaluation of the treatment and what types of endpoints may be very different.
“I think when we take a look at ‘the patient voice,’ there are things that all patients agree on. We all want clinical trials that really work for us.
“We want clinical trials that have more expansive eligibility criteria that reflect the patient populations who will be using these drugs. We want expanded access programs that work for us. We need to work on facilitating how patients get unapproved drugs.
“We need informed consents that are meaningful to patients—that aren’t just page after page of legalese that patients don’t read or don’t understand. We need a better informed consent procedure.
“So it’s about putting the patient in the forefront— that’s what I see as the patient voice, or as I previously mentioned, ‘the cry of the patient,’ to make clinical trials more patient-focused.
“I’ll just end by saying, what should be the primary endpoint of a trial? Should it be overall survival? Should it be progression-free survival? Should it be a response rate?
“Well, the primary endpoint of any trial should be the patient.”
