Enthusiasm and Vision Guide the Head of FDA’s Oncology Office

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Richard Pazdur, MD

Developing cancer agents is more complex than other drugs because we are dealing with a different risk-benefit profile. Our drugs are often toxic, and our patients have different expectations regarding the timeliness of approval and the kind of side effects they’re willing to accept. So, it is important that the process is as transparent as possible.

— Richard Pazdur, MD

In  2005, Richard Pazdur, MD, was named the FDA’s Director of the Office of Hematology and Oncology Products. By any measure, being arbiter of the nation’s oncology drug pipeline is a daunting prospect, but Dr. Pazdur sees it as an opportunity to encourage his talented staff to work for the greater good of our nation’s cancer patients. After assuming this position, he initiated an open-door policy to foster collaboration. “I spend a good part of my day at the office talking to people at every level of the drug evaluation process. FDA staff spend many months involved in the review of an application, with multiple internal interactions involving the more than 50 medical oncologists who work in our office. When a drug is discussed at ODAC [Oncologic Drugs Advisory Committee], it is rare, if ever, that a question or concern arises that we have not already heard before,” said Dr. Pazdur.

A Childhood in a Tight-Knit Community

“I grew up in a Chicago suburb called Calumet City, located 25 miles due south from the convention center where ASCO holds its Annual Meeting. It was a large Polish Catholic community. My parents were children of Polish immigrants. My mother was one of nine children, my father one of seven. We all lived within a few miles of each other, so there was always an aunt or older cousin watching out for you as a kid,” said Dr. Pazdur.

Despite the tight-knit community, Dr. Pazdur commented that Calumet City had a past. “In the 1950s, Calumet City was known as “Sin City,” boasting more bars and taverns per square mile than any place in the nation. There were underworld connections from remnants of the Al Capone gang. On the outskirts of our community was a strip called State Street that was lined with after-hour’s bars and seedy men’s clubs,” said Dr. Pazdur.

Dr. Pazdur credits an early experience with health care as a catalyst for his career. “When I was in grade school, my father began losing his eyesight and by the time I graduated he was completely blind. I accompanied him to his medical appointments, and much of my childhood was spent in doctor’s offices doing my homework waiting for my dad, so I had an early introduction into the world of medicine,” said Dr. Pazdur.

He added, “The experience with my father influenced my decision to become a physician. Losing our breadwinner to blindness had significant emotional and financial effects on the family.”

Profound Influence of Early Mentors

Dr. Pazdur regards his education as an enriching community experience. He went to the same grade school and high school that his mother and her sisters and most of his cousins attended. “In high school I was editor of the school newspaper and yearbook. I still keep in contact with my journalism teacher, Ms. Beverly Stanislawski. I received an email from her just the other day. I use the skills I learned in her class every day at the FDA, when writing or editing papers and drug application reviews.”

After high school, Dr. Pazdur entered Northwestern University in Evanston, Illinois. “During my college years, I was interested in sociology. A sociology professor, Dr. Zena Smith Blau, impressed me by her pure love of academics. I distinctly remember her telling me that to be successful in academics you need enthusiasm and a vision for what you’re doing. The enthusiasm of her lectures and her interest in sociology mesmerized me. Zena Blau and her husband were major figures in the national and international academic world of sociology, and their work is still cited in the literature,” said Dr. Pazdur.

“When at Northwestern, I was contemplating a career in sociology. I’d worked with Dr. Blau on sociological projects examining the assimiliation of the Polish-American community in Chicago. Dr. Blau’s emphasis on enthusiasm and vision in an academic life has had a profound influence on my career to this day,” said Dr. Pazdur.

Decisions in Medical School

Deciding on a career in medicine, but needing to stay close to home to help his family, Dr. Pazdur attended Loyola Stritch School of Medicine in Chicago. “Because of my father’s illness, my parents depended on me for help around the house, which was one reason I chose to stay in Chicago for medical school. When I interviewed there, I really had a sense that the faculty took a personal interest in every medical student. The spirit of the school exemplified a Jesuit philosophy of combining the academic and personal growth of the student with a personal commitment to improve society. This commitment influenced my work at the FDA. It isn’t a coincidence that we have four Loyola Stritch School of Medicine graduates who work in our oncology office at the FDA. This probably reflects the Jesuit commitment to professional service to the public,” said Dr. Pazdur.

Dr. Pazdur noted that upon entering medical school, he initially wanted to become a psychiatrist. “I changed my mind and decided to become a cardiologist. I did a 4-month rotation in cardiac cath lab and did quite a few catheterizations. I was accepted to a cardiology fellowship; however, one of my last internal medicine rotations was in medical oncology and so I became interested in cancer care,” said Dr. Pazdur.

“I did my medical oncology solid tumor training at Rush-Presbyterian-St. Luke’s Medical Center and I did an additional year of hematology at the University of Chicago. But oncology in Chicago at that time was very different than now. There were no National Cancer Institute [NCI] phase I or phase II drug development programs in Chicago, so I referred patients to Wayne State in Detroit for these investigational drugs, since Wayne State had a contract with the NCI. During this time I was offered a position at Wayne State. I accepted the position and moved to Detroit in 1982, the same year I married my wife, Mary, who is an oncology nurse practitioner. Because time and money were tight, we spent our honeymoon in Detroit planning our move from Chicago,” said Dr. Pazdur.

Career at MD Anderson

Dr. Pazdur worked at Wayne State University where he became the director of the fellowship program. “I trained many fellows who went on to become nationally recognized in oncology, which is still a source of pride. And after about 6 years at Wayne State, I applied for a position at MD Anderson Cancer Center in Houston,” said Dr. Pazdur. After interviewing with Dr. Bernard Levin, whom he’d met previously while at the University of Chicago, Dr. Pazdur accepted the position in gastrointestinal oncology at MD Anderson and moved with his wife to Houston.

He spent 12 years at MD Anderson, once again serving as Director of the Fellowship Program. “Similar to my Wayne State experience, many of my fellows went on to very successful careers. I’m very proud of their accomplishments. I truly enjoyed every day I spent at MD Anderson, never dreaming that I’d leave the institution. However, I collaborated with several drug companies as a clinical investigator and I had the opportunity to present my clinical trials to the FDA. During these visits, I began to understand the vital role the agency has in drug development,” said Dr. Pazdur.

A Vision for the FDA

He continued, “I had a vision for the FDA to become a much greater participant in drug development and in the overall field of oncology. It was important to break down the walls that separate the FDA from its stakeholders and enhance the dialogue within the oncology community. In addition, my vision was to have our oncology reviewers develop expertise in specific malignancies. This led to the creation of our oncology office organized in disease-specific teams to review applications. Another goal was to have a more unified program since oncology applications were previously dispersed between different offices and centers at the FDA. This was in part accomplished with the establishment of the oncology office in 2005, as well as the oncology program, which coordinates both internal FDA oncology activities and our activities with stakeholders, ” said Dr. Pazdur.

Dr. Pazdur also stressed that his vision included a need to explain to the oncology community exactly how the FDA works to bring cancer drugs to the market. “We’ve worked with ASCO, AACR, ASH and various patient advocacy groups. We have conducted workshops both at the Annual Meeting and throughout the year to inform the community about our current and future initiatives. Developing cancer agents is more complex than other drugs because we are dealing with a different risk-benefit profile. Our drugs are often toxic, and our patients have different expectations regarding the timeliness of approval and the kind of side effects they’re willing to accept. So, it is important that the process is as transparent as possible,” said Dr. Pazdur.

Drug approval is an exhaustive iterative process requiring collaboration among multiple parts of the FDA. Cancer patients need new drugs, so the approval process is one of urgency tempered by necessary resolve to make sure that every drug that goes to market has proven benefit. Dr. Pazdur anticipates a bright future ahead. “We’re seeing a transformation in the way we develop and deliver cancer therapies. These are very exciting times.”

Are there any regrets? “Yes, only one though. Someday in the future I’ll have to retire, and I won’t be able to participate in this vital process that will ultimately lead to cures in many cancers,” said Dr. Pazdur. ■