As an oncology nurse practitioner at NCI’s Clinical Center and wife of FDA’s Richard Pazdur, Mary Pazdur knew cancer drug development inside and out. When she was diagnosed with ovarian cancer, she and Rick got to know “the other side of the stethoscope.” 

In his 25 year career at FDA, Rick has shaped the FDA approach to drug approval, setting forth a set of criteria accepted by drug companies, academics and NCI. And for 16 years, Mary was by his side, with compassion, intuition, and practicality. She was described by one colleague as having a “combination of efficiency and great humanity, […] compassion and strength.” 

This interview with Rick and Mary Pazdur was recorded in 2015, a few months before Mary died. The couple was interviewed by Ellen Stovall, three-time cancer survivor and pioneering patient advocate, on behalf of the National Coalition for Cancer Survivorship. Stovall also died a few months later—in January 2016—from cardiac complications due to her cancer treatments.

The Pazdurs were something of an oncology power couple. 

The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.

“You really have had a partnership in medicine before you became husband and wife and physician and patient,” Stovall said. “And it’s a distinctive, if not unique situation for a lot of people to witness how you manage to straddle both what you know professionally and what you’re experiencing personally.”

Mary credited working as an oncology nurse with preparing her for her diagnosis.

“I’ve always worked in oncology. Even when I was an undergraduate nursing student, I was always drawn to oncology because so many different diseases affecting so many body systems and developmentally along the continuum of life,” Mary said. “And the silver lining is you learn a lot of existential lessons about living and dying when you’re almost too young to learn those things. 

“But I think it has prepared me in advance because many times I would be in an exam room with a patient as a healthcare provider wondering, I wonder how I would cope with that situation. What would I do? What would I think? 

“So I’ve had the luxury of some rehearsal, and very few people have that opportunity in their lifetime, and it’s made it in some ways easier and respectful of that experience with those people. And you see also the strength and the resiliency of the human spirit that comes through.”

Serving as Mary’s caregiver has given Rick a new perspective.

“I think that seeing how a patient goes through a treatment is much different on the other side of the stethoscope than looking at a patient in an exam room and spending 15 minutes with a patient or a half with a patient, whatever it may be,” Rick said. “But living with a patient with cancer is an experience that really puts a different perspective on drug development, drug regulation, and also the physician doctor role.”

In the years following Mary’s death, FDA found asbestos in Johnson’s baby powder—a product Mary used every morning after getting out of the shower. Rick has since filed suit against Johnson & Johnson in a case that is still pending.

In October 2024, Rick celebrated 25 years at FDA. 

In a 2025 interview with The Cancer Letter commemorating this milestone, Rick reflected on the battles he fought over the past quarter-century at FDA. A lot has changed since then. “I had no idea when I came in 1999 what oncology would’ve developed in 25 years,” he said.

Mary’s funeral service was held in December 2015, and in a final act of compassion and great humanity, the catering was prepared by a Syrian immigrant who cooked at the Montgomery County Hospice, where Mary was a patient.

Mary had hired her to make sure that the last arrangements she would ever make would help someone establish a new life in a new country.

This episode of the Cancer History Project Podcast is available on Spotify, Apple Podcasts, and YouTube.

More about Rick and Mary Pazdur:

Remembering Ellen Stovall:

Transcript

This episode was transcribed using an AI transcription service. The transcript has been reviewed by the Cancer History Project team, but may be imperfect.

Katie Goldberg: The Cancer History Project is an online archive of the history of oncology, collaboratively curated by the institutions and people who shaped it.

We have over 60 partners, spanning academic cancer centers, government agencies, advocacy groups, and even the occasional podcast.

Visit us online at cancerhistoryproject.com to dig through our archives.

I’m your host, Katie Goldberg.

June was National Cancer Survivor Month. Also in June, debate over funding cuts for cancer research took center stage in Congress as the Trump administration seeks to proceed with a nearly 40% cut to cancer research funding.

For Mary Pazdur, research funding was personal. As an oncology nurse practitioner at the NCI Clinical Center, she worked on clinical trials to develop new cancer treatments. 

Then, during her three-year struggle with ovarian cancer, she followed the path of her patients: relying on drugs studied by her colleagues, developed with NIH research funding, and approved by FDA.

In fact, her husband, Dr. Richard Pazdur, has spent over 25 years as FDA’s chief cancer strategist—starting as director of the FDA Office of Hematology and Oncology Products in 1999, and today serving as director of the FDA Oncology Center of Excellence as well as the acting director of the Office of Oncologic Diseases. 

This month, we’re bringing you a 2015 interview with Rick and Mary, recorded a few months before she died.

At a conference not long after this interview was conducted, Rick said: “This three-year period of time has given us the opportunity for observation of the healthcare system from the other side of the stethoscope. You see the worst of the system; you see the fact that you’re not immune just because you’re a doctor or a member of a doctor’s family.”

In this interview, the couple reflects on when cancer research gets personal, and how this perspective will continue to shape Rick’s career.

Rick and Mary met in June 1979, at Rush Presbyterian Hospital in Chicago. Mary Patricia Bagby was a nurse, and Rick was on the first day of his oncology fellowship.

Both were as Chicago as it gets. Rick comes from a Polish family in Calumet City, south of Chicago. Mary came from a large Catholic family in Tinley Park, also on the southside.

They married in 1982.

When Rick took the job at FDA in 1999, Mary accepted a position as an oncology nurse practitioner at NCI. 

Rick has shaped the FDA approach to drug approval, setting forth a set of criteria accepted by drug companies, academics and NCI. And for 16 years, Mary was by his side, with compassion, intuition, and practicality. She was described by one colleague as having a “combination of efficiency and great humanity, […] compassion and strength.” 

Mary eventually took the therapies her colleagues at NCI had worked on. And when she needed an experimental drug on a clinical trial, she received a Compassionate Use authorization from FDA, which grants a single patient access to an investigational drug—a process Rick can now appreciate deeply from both sides.

This interview was conducted by Ellen Stovall, three-time cancer survivor and pioneering patient advocate, on behalf of the National Coalition for Cancer Survivorship. Stovall also died a few months later—in January 2016—from cardiac complications due to her cancer treatments.

This episode is accompanied by a robust archive about Rick and Mary Pazdur, as well as further reading about Ellen Stovall. Visit the link in the description of this episode to learn more.

The Cancer History Project is sponsored by the American Society of Clinical Oncology and the University of Texas MD Anderson Cancer Center. 

In the years following Mary’s death, FDA found asbestos in Johnson’s baby powder—a product Mary used every morning after getting out of the shower. Rick has since filed suit against Johnson & Johnson in a case that is still pending.

Mary’s funeral service was held in December 2015, and in a final act of compassion and great humanity, the catering was prepared by a Syrian immigrant who cooked at the Montgomery County Hospice, where Mary was a patient.

Mary had hired her to make sure that the last arrangements she would ever make would help someone establish a new life in a new country.

Richard Pazdur: Hi, my name is Richard Pazdur. I am the director of the Office of Hematology and Oncology Drugs at FDA. And prior to coming to the FDAI was at University of Texas MD Anderson Cancer Center, where I was a GI oncologist and also did a lot of phase one drug development there also. So I have kind of the perspective of seeing the field of medical oncology evolve over the past 33 years here. I began my training in the late 1970s and have seen really oncology develop during this three decade period of time. And it’s been a really interesting time because we’ve seen areas where we had very few therapies and we’ve seen significant advances both in the treatment of certain diseases such as multiple myeloma, such as renal cell cancer to just name a few. But in addition to that, advances in supportive care also we’ve seen, so it’s been a very rewarding career.

It’s one that I think we’re seeing major advances in our understanding of the malignant disease process. This enables us to develop more rational drugs, and I think our job at the FDA has become easier because the drugs simply are better drugs. No longer are we having to argue about whether the drug should be approved. Many times we’re arguing how fast we can approve the drug because it’s such of a major advance for the treatment of the disease. So it’s a fascinating time to be in medical oncology. One of my only regrets that I tell people I wish I could be here for the next 30 years because I think that that’s going to be even a more fascinating period of time for the treatment of diseases. But it’s an interesting phenomena that we’ve had of looking at diseases where there simply were no other therapies and where we’re seeing multiple therapies being developed, we’re seeing major advances in our understanding of the immune system and how the body interacts with cancer and developing appropriate drugs based on that understanding, we’re seeing interesting understanding of pathways of disease, molecular pathways, and be able to target specific drugs.

Many times these drugs are less toxic. They have a very much of a rationale for their drug development. When I first started out in the late 1970s and the early 1980s, I called that period of drug development, kind of the roulette wheel of drug development. We had a classical cytotoxic drug that was being developed. We really didn’t know what drugs, what diseases rather were going to be studied or what diseases the drug was going to work in. So we just did numerous phase two studies just to determine whether the drug was going to be effective or not. Now we have a really understanding of what the disease is and how the drug works with that disease. So we have a much more rational approach to our drug development. My career began in Chicago. In fact, I originally was not interested in becoming a medical oncologist for people that, and I tell this story frequently.

When I first went to medical school, I was very much interested in becoming a psychiatrist. Well, that passed and because of the hospital that I was at, which was very focused in cardiology, I was all signed up to be a cardiology fellow after completing medical oncology. And then what happened was that I took my first oncology rotation relatively late during my residency and really fell in love with the field. I thought really took advantage of my understanding and expertise in training in internal medicine and really applied it toward the cancer patient. So it was a much kind of circuitous route that I had to come into the field of medical oncology. I remember very well, I was all signed up for the cardiology fellowship and I decided I really wanted to go into oncology. And at that point, since it was relatively late, all the oncology fellowships were closed.

They had already selected their candidates. So I remember very well I was at St. Francis Hospital in Evanston, Illinois, and at that time they had a public phone that took quarters. So I got something like $10 worth of quarters, went down to the lobby of the hotel and actually started putting in the quarters and calling any oncology program that was available that had slots. And I would ask them, did you fill your slots? Are there positions open? And luckily in Chicago, which was not far from where I was doing my training at Rush Presbyterian St. Luke’s Hospital, there was a position open at that time. I thought that that program was a huge program. Everyone has to remember that in the 1980s or in the 1970s, I should put it, that oncology was a relatively embryonic discipline. There were only a handful of medical oncologists in any university.

For example, at Loyola, which has a huge cancer center. Now, we only had one medical oncologist in Chicago at Rush. I think there was about eight medical oncologists, which was the largest program that they had. And I remember looking at the mass head of the letterhead or the letterhead rather, and they actually had one person that just did breast cancer. And I couldn’t believe that one medical oncologist could be so to only do one particular tumor. So things have changed dramatically. The discipline of medical oncology really has grown and matured. And our understanding has also, the other thing that’s quite interesting, when you start a field, you project on what you think the field will be. And I frequently tell people when I started in the 1970s, I thought medical oncology was going to be a very small boutique field where everyone would go on clinical trials, where everyone would be treated in major medical centers, that the bulk of the research would be not from pharmaceutical companies, but from the NCI.

And boy was I wrong. Obviously the bulk of drug development now is being done in the private sector through the pharmaceutical and biopharmaceutical industry. Private practice is a major component of how patients are treated in the United States. So different things have happened and are not necessarily what you think they may be when you start out in a field. So that gives me pause for the next 30 years to think of and what oncology will look like. I’m really kind of jealous of the people that are just entering the field or early in their career. I think that they have a fantastic career ahead of them. There’s a lot of distractions in medicine about the cost of the drugs, about how private practice is changing, how academic medicine is changing. But I think we have to take a look at the really big picture here, and that is the patient and the physician and that relationship. And it is a very important relationship that I’ve always held very sacred and important in my life.

Ellen Stovall: Well, for somebody who enjoys being a physician, what was it at that point in your career when you said you wanted to come to the Food and Drug Administration? What did you want to accomplish at the agency when you came there? And do you think you’ve achieved many of those goals?

Richard Pazdur: I think I achieved many of the goals, but I’d like to give you the backstory on the why. I came to the FDA. I had done a lot of drug development with various pharmaceutical, various pharmaceutical industry type of studies and had actually come to the FDA and developed a drug. And I always stated, I’m probably the only person that was a PI on the study that had the drug rejected by the FDA and is still working at the FDA when the drug was rejected by the FDA. So there’s some irony in coming to the FDA, especially when I arrived in 1999. It wasn’t a difficult decision. There are certain decisions in my life that I made that I always knew what they were, right? But there was this inner voice that said, you’re doing the right thing. When I went into medicine, I never had a second thought that that was the wrong career choice.

When I met my wife Mary, I never thought that that was a wrong decision. It was, go ahead. When I moved to Detroit from Chicago, people would say, you’re moving to Detroit. And I said, yep, I’m moving to Detroit. And it was one of the best opportunities in my life. Likewise, when I moved to Houston and took the job at MD Anderson, I just realized that that was the right job. And then finally the decision to make come to the FDA was one that I never regretted and is something that I think was an excellent career move. Interestingly enough, a colleague of mine I saw recently, and he said, Rick, the decision that you made to come to the FDA was the best decision in your life. And I just had to chuckle. And I said, well, it took people 16 years to realize that, but it happened.

And I’m happy that I came to the FDA. I saw the potential for the FDA. And here again, it needed an external face. People had to understand what we’re doing at the FDA. And I think through the collaboration and the cooperation of patient groups, asco, A CR, ash, the numerous interactions that we have, we’ve really put a different face on the FDA much more external face and illustrates the importance of the work that we do here. I think it’s important for people to understand that we’re not the roadblock or the barrier or the challenge to get drugs approved. We’re here to protect the American public to promote the health of the American public. And I think that that is very important that people understand that The FDA has really two basic missions. One is to protect the American public, but the other one is to promote the health of the American public.

And I think that there always has to be this balance and people have to realize that this is a balance that has to be attained in any drug approval or in the development of any drug program, so to speak. So really to put a face on the FDA to really have an external presence, to show people that we are out there concerned about them, that we have their health is foremost in our mind. And I think that may have not been present before I came here, at least to the degree that it is now. One of the other things that when I started the job 16 years ago, that it was very important to start recruiting people that were young, that were bright, that really wanted to work at the FDA that saw a future in the FDA. And I think that we have been tremendously successful in that.

When I started at the FDA in 1999, there probably was around 10 to 15 medical oncologists. Now we have over 70 medical oncologists, and they include not only medical oncologists, but pediatric oncologists, radiation oncologists, we have nurse practitioners and oncologist that work for us, PAs that work for us. So the growth of our divisions, our three oncology divisions has been really exponential during this period of time. I think it’s important for people to understand that this did not occur in a vacuum. This required a lot of people, a lot of external help, a lot of internal help in the agency really to develop a oncology program. One of the things that I also realized is that we have collaborations with academics in the field and reviewing the applications as well as hearing the patient’s voice. So one of the things that I did about five or six years ago when the office was reorganized was really to create disease specific teams of teams of physicians that only do lung cancer, that only do breast cancer, that only do multiple myeloma, that only do GI malignancies.

And this provided an expertise to those individuals, the ability to really understand the entire scope of drug development in a particular area. And I think that this was tremendously successful in giving people a job satisfaction to know that they’re part of the drug development program rather than just being a regulator, than just being somebody that finds a problem with this disease. This was also an interesting impetus in really getting drugs out sooner because people realize the importance of some of these major breakthrough therapies that we have in front of us. And by really seeing what’s going on in the field, it’s not just another drug application, it’s an application or a drug that’s going to have a major impact on the health and the welfare of patients with a specific disease. I always state that time is relative. When a patient knows that a drug has activity in a certain disease, a delay of a month, two months, three months may have tremendous importance if one doesn’t have an understanding of how that drug fits in.

For example, if a drug is being studied in a phase one study, that time element may not be that important, but when somebody knows what the drug holds for them, it’s particularly important for us to get that drug out as soon as possible. And you could see that we have developed collaborations with drug companies to really expedite the drug approval system here, looking at accelerated approvals, fast tracks, breakthrough therapies, which recently came about, which really I think has a tremendous impact on our staff as far as taking a look at how they can really, really do their work in a more expeditious manner and really facilitate drug development. So I think my goal was really to make us a partner in drug development. And I think I accomplished that with the help of a fantastic group of people. And here again, I thank the organization for giving me this award, but it’s really not for me.

But this award is really for the people that work in oncology. And I have been blessed to work with many talented people. I recently got a phone call from somebody that I worked 30 years ago with in oncology, and this was one of my first physician assistants that worked with me. And we had a very special relationship. And there are certain times in your career when you’re working with a group of people or a specific person that you know, it is just a special time, things just click. And this was one of them when I was at Wayne State and he asked me, I had such a fantastic time working with you, did you ever have a similar experience after that? And I said, Dan, I’m having the exact same thing now. I really am really having a time of my life, so to speak, working with a group of people that I feel are committed to a common goal, that are intelligent, that want to do the best thing, that want to develop a common mission of the FDA that really share a common goal here. So it’s really one of the special times that I’ve had in my career over the past couple of years as we’ve reorganized the office, as we’ve developed disease specific teams that we’ve witnessed the fruition of our recruitment efforts with many, many really young excellent medical oncologists. Coming to the FDA,

Ellen Stovall: The agreement between FDA and industry that was part of the PDUFA reauthorization advanced the concept of a patient focus, and it’s well known to most of the patient advocacy groups that might be listening to this interview with you, that they characterize you as opening up the agency and not just reaching out but bringing in, can you comment on the recommendation that’s in PDUFA of a patient advocacy focus and drug development and the positive reputation that your office has achieved in terms of incorporating the patient’s voice into a regulatory system? That depends so much on heart evidence?

Richard Pazdur: Well, I think it’s very important to hear the patient, but we also have to be realistic that there isn’t a one patient voice. The patient voice is really represented by many different opinions, many different patients. And that voice may change as one goes through the illness. For example, a patient that has had an adjuvant therapy that is cured of their disease may have a much different perspective regarding the treatment of metastatic cancer that is incurable than a patient or a family member that actually has metastatic disease. So we have to be cognizant that when we talk about the patient voice, it really isn’t a voice. It’s really many voices that we hear, and we have to be realistic and we also have to be cognizant that that voice may change with time. It may also be representative of where an individual may be with a specific disease.

And even within that situation, for example, looking at the treatment of far advanced metastatic disease, there may be varying opinions regarding individuals that have the disease and we have to be respectful and hear all voices. One of the things that I really emphasize is that when we hear the patient voice, we really shouldn’t get lost in the tree, so to speak, in arguments of whether one should take time to progression or overall survival as the endpoint. We really should look at larger questions that affect oncology, and these are some of the projects that we’re looking at at the FDA. For example, we’ve heard from almost all patients that they want clinical trials that work for them. They want eligibility criteria that are broadened, that represents the real world, that don’t exclude patients because they’ve had a prior malignancy or they’re a poor performance status, or they have a HIV infection.

We want to look at that. And this is one of the projects that we have ongoing in the division in all three of the oncology divisions, the clinical divisions looking at ways of broadening eligibility criteria. And this is a project that we will have ongoing this year with some of the professional groups and also to bring in industry to look at how we can broaden eligibility criteria. This has two possibilities or two potentials. One obviously is to give a real world picture of patients that will be receiving the drug once it’s approved, if we include patients that may not meet the standard eligibility criteria. In addition, it may also provide treatment opportunities for patients with promising drugs that may have been excluded because of overly restrictive eligibility criteria. One of the other bigger themes that come out in the patient voice is really the voice of recognizing certain toxicities.

And we’re working with the NCI and with several professional groups really to look at broadening labeling, which will incorporate the patient’s voice. Patient reported adverse events, for example, many times physicians and even patients underestimate the toxicities of the therapy. For example, fatigue might be graded as grade two, but it may be lasting weeks or months, and that may have a tremendous impact on the patient and his or her family. So those are kind of two of the criteria that we’re looking at or two of the larger projects that we’re looking at when it comes to really incorporating the patient voice and the patient experience that we’ve heard through our numerous interactions with patients throughout this 16 year period of time. We’ve had patients that I’ve worked at the FDA, we’ve implemented patients on our advisory committees. We’ve also had internal meetings with patient groups that are serious, that are truly listening to them.

We’ve brought patients as well as physicians in on applications that we do not take to odac to hear what their specific opinions might be regarding the approval or non-approval of a particular drug or indication. So really this has been an extremely important thing for me, really to get the patient voice into this experience. As many of you know, my life had been transformed over the past three years with my wife having ovarian cancer. And this gives me a special perspective on the treatment of patients with cancer. Obviously it’s very hard to say what specific impact it has, but to say that it has an impact is obviously a true statement. And I think that seeing how a patient goes through a treatment is much different on the other side of the stethoscope than looking at a patient in an exam room and spending 15 minutes with a patient or a half with a patient, whatever it may be. But living with a patient with cancer is an experience that really puts a different perspective on drug development, drug regulation, and also the physician doctor role.

Ellen Stovall: Well, we’re very lucky to have you here today, but we’re especially grateful that Mary agreed to be part of this conversation because you really have had a partnership in medicine before you became husband and wife and physician and patient, and it’s a distinctive, if not unique situation for a lot of people to witness how you manage to straddle both what you know professionally and what you’re experiencing personally. And if the two of you could just talk about what that’s been like and how you’ve had the very best of times and how you’ve had the worst of times of having to manage this illness on a very personal level.

Richard Pazdur: Mary, do you want to start?

Mary Pazdur: I’ve learned a new found respect for the caregiver. So since he’s had to become a caregiver, in addition to the other hats that he wears, I’ve always understood the important role that each of us with cancer has and having someone who was helping them through, but it’s the patient usually is the center of the focus, and it’s very easy for the patient to forget that they couldn’t be there if it weren’t for the other, beside the healthcare professionals supporting them and helping them and being compassionate, but the people at home, the family. So that’s been a respect I’ve always had, but probably I felt it a little bit more personally. So I’ve been blessed. I’ve been very blessed.

Yeah, I think as you know, the medicine and nursing care is an art and a science, and it’s a very special, unique blend of being able to balance those. Two is to maintain the rational scientific objective side, but yet know that there’s a human side of the care. And I think that’s one of the early things that attracted me about my husband is that I could always see the joy and the intrigue and the love of working with people. Being a humanitarian, it’s difficult because it is a fine line between the emotion and the science, so it’s a balanced juggling act.

Ellen Stovall: Do you think he handles that well? In

Mary Pazdur: General? Yes. I’ve been very blessed. I have a wonderful large extended family, a beautiful neighborhood friends. My former work colleagues before I retired are still in touch. I could never have imagined that I would have such a lovely extended support system that I’ve experienced.

Ellen Stovall: And you’re an oncology nurse?

Mary Pazdur: Yes.

Ellen Stovall: Can you sort of start a sentence saying to me, in my years in the career with Rick, this is the role I played?

Mary Pazdur: Oh, well, my job here in the DC area was at the NIH and the National Cancer Institute, which I’ve always worked in oncology. Even when I was an undergraduate nursing student, I was always drawn to oncology because so many different diseases affecting so many body systems and developmentally along the continuum of life. And the silver lining is you learn a lot of existential lessons about living and dying when you’re almost too young to learn those things. But I think it has prepared me in advance because many times I would be in an exam room with a patient as a healthcare provider wondering, I wonder how I would cope with that situation. What would I do? What would I think? So I’ve had the luxury of some rehearsal, and very few people have that opportunity in their lifetime, and it’s made it in some ways easier and respectful of that experience with those people. And you see also the strength and the resiliency of the human spirit that comes through.

Ellen Stovall: So with the two of you, you’ve both observed human behavior between physician and patient being treated for cancer. Has your experience taught you anything new or things that you would want to tell other people who are listening to this, what worked best and what works best and what we need to work harder on to make this very difficult experience of living with and beyond the diagnosis of cancer?

Mary Pazdur: What has become harder for me is that the acceleration of the pace of change in healthcare has become so rapid when you go over, I’ve had a 40 year history, and you anticipate, yes, of working as an oncology nurse, you can anticipate trends and see them coming and perhaps prepare and speculate and wonder. And now there’s so much emphasis on rapid change and rapid, even in the business models of healthcare organization and delivery, that people don’t have the luxury of time to adjust as well. And it puts a lot of stress on the caregivers that are working in these systems. I think more emotional stress.

Richard Pazdur: Yeah. Well, one of the things that I emphasize when the diagnosis was made, and as we’ve been going through this whole process, and it’s been over three years now since Mary’s original diagnosis of ovarian cancer was really that we didn’t want to be treated any different than anybody else because our experience has always been when people are treated differently, there always is mistakes, there’s always irrational decisions. And my whole thing is treat me as you would treat anyone else. I don’t want anything special. I don’t want you moving up appointments. I don’t want to be getting in front of anybody for a CT scan or having Mary get in front of anybody. All I wish is just to be treated as a patient. And I think that that is one of the most important things and something that we’ve always talked about. The other thing is not to get lost in the minutiae and to always look at the big picture.

Having been in healthcare, both of us, there’s always mistakes that are going to be made. There’s mistakes of somebody ordering the wrong laboratory exam, somebody drawing the wrong blood, somebody not making an appointment, somebody forgetting to take the appropriate x-ray. And rather than getting worked up and anxious and resentful against the process here, take a whole look at the big picture of where you are in the disease, where you are in life. Because in my experience in dealing during this 30 plus year career in cancer, cancer brings out the best and it brings out the worst in people. And you want to be in that upper triangle of having it being the best that it brings out to you in your interactions with people and not the worst. And that’s why I always say, take a look at the big picture, some small things such as an x-ray, a blood test, a missed appointment, not going to have any effect on the big picture here.

So take a look at the big picture. I always look back when I first met my wife, and that was in 1979 when I was beginning my fellowship. And I met Mary on the first day of my fellowship and I always used to tease the, I was the director of the oncology fellowship programs both at Wayne State and MD Anderson. And I used to tell people that on the first day, the orientation about our story of meeting on the first day. So I used to kid the people that take a look to your right, take a look to your left. You may be marrying one of these people down the line, so to speak, because professional relationships do occur and they sometimes turn into personal relationships too. I always give the joke that our first date was over a bottle of Adrian Ison in the exam room, which sounds somewhat peculiar, but that was the truth. It was not over a bottle of chardonnay or whatever, but it gave us a common experience. And I look back to all of those early patients that were treated with Mary and myself and the people at Rush where we were doing what we were working at that time in Chicago. And it really was a special time in my life and I’ve enjoyed the partnership that I’ve had with Mary during those years.

Mary Pazdur: The identity of a healthcare professional versus a patient I identify now with my fellow patients versus being a nurse. And that’s been a transition that very slowly has evolved and it’s been a positive one. I think what I found again is that patients should support each other and help each other and get through and have tips and insights and just many, many things. And I don’t think I underestimated the importance of that role of having a peer support group, but I valued it much more now being on this side. So that’s been a learning experience.

Richard Pazdur: I think for me it’s been a transition. You go through various transitions in your life and they’re not mutually exclusive. You could have them together. And for me it was from an oncologist to a drug regulator and now somewhat as a patient advocate, so to speak, and I have to be an advocate for my wife on a personal level. However, one thing that I knew from Mary from the very beginning is that she has to run the show in the sense, and so I’m in the background. If she wants my advice, I will give it to her, but I am not the type of person and our whole relationships has been this way of saying, it’s going to be this way because I want it this way, or you should do this. I want her to make the decisions. And that sometimes could be a difficult situation.

It’s also a difficult situation in dealing with doctors and nurses because they know what you know and sometimes you even know more than they know about a certain drug or a certain class of drugs. So it’s very difficult sometimes to balance that relationships. Many of her physicians have been also friends of ours or former trainees of ours, or she knew at the clinical center. So it’s a very unique relationship. But here again, all I ever asked for is treat me as the patient, not as the director of oncology at the FDA. I never wanted that relationship with the physician. It’s interesting, one of the physicians that we had an interaction with recently, I don’t know if she meant to impress me, but she went through all of the collaborations that she had with numerous pharmaceutical companies and she said, I’m collaborating with this company. I’m collaborating with this company, I’m collaborating with that company.

And in the back of my mind, all I was saying, all I want you to be is my wife’s doctor, I really don’t care about your interactions with a specific drug company. I just want you to do the right thing for my wife, basically in your clinical expertise. And it was somewhat ironic because at the end she turned to Mary after delineating all of these drug companies that she was working with and said, Mary, I want you to know I’m going to do the best thing for you because I have the best interests of you in mind. And I was somewhat taken aback by this because I said, well, I didn’t say this, but in my mind I thought, well, if you really have to say this, are you having an internal conflict of your own? And I don’t know if that was the case, but it was something that ran through my mind.

But here again, all we’re asking for is the same quality of care that you give to everybody else. And here again, I think it’s very important for patients to realize this and family members to realize this, that things are going to go wrong with anybody’s care. That’s a fact. Nobody’s care, no matter who they are, are going to have a course of therapy that goes on for three or four years where something doesn’t go wrong or there’s daily problems and you got to forgive the people that make these mistakes. Take the upper road here that you are working together with them against this disease, you not working against them. And I think it’s very important for patients and physicians really to realize that they’re on a team here working together to help the patient against the disease, so to speak. There also is a time, and I dunno if Mary wants to talk about this, of when you want to think about hospice and when you want to think about palliative care and when you have to say, well, perhaps my therapy is not helping me.

Perhaps the toxicities are too great. That’s an issue that I think all patients have to face. It was a very interesting experience I had. I was listening to a patient advocate talk about a specific drug and the toxicities of the drug. And then I was at the FDA hearing our reviewers talk about the drug and the toxicities. And then I went home and my wife was experiencing these toxicities. And it’s a much different experience that you have when you have that intimate knowledge of the toxicity. It’s so much more. And I think that that is one of our major drawbacks in medical oncology and in the clinical trial system is really underestimating the toxicities of some of these therapies. And here again, this is why I am so adamant about getting the patient’s voice in the assessment of adverse events and drug toxicities. Frequently it’s very difficult and both of us are oncology professionals, and were the symptoms that Mary was having, were they disease related?

Were they related to the drug? It’s impossible sometimes to know. They could be either one, they could be both. They could be neither. So it’s a difficult situation that you sometimes just have to work through, but it’s one that sometimes time will tell. But I would say that one thing that has one major issue that I think that this whole experience has taught me is our underestimation of drug toxicity from the patient’s perspective. A physician simply doesn’t have that A physician spends 15 minutes, a half hour, perhaps an hour with a patient. They’re not there at two o’clock in the morning. They’re not there when they leave their wife at eight o’clock in the morning and she’s sitting on the couch because she’s fatigued, and when you come back at five o’clock, she’s still sitting on the couch fatigued. That’s not a grade two toxicity.

It’s really life altering and people have got to understand that. And I think sometimes patients themselves don’t report some of the toxicities. They fear, for example, that they may be taken off a promising drug that they may anger their doctor. Perhaps they’re confused that it may not be related to the drug. But I really would encourage people really, and especially patients really to have a voice, and this is what I’m emphasizing, should be the patient voice. Again, it’s not about whether we take PFS progression-free survival response rate or overall survival. Those are our can issues that we will work out. But there are major issues that really need to be addressed in the clinical trials enterprise here, and we really need to bring the patient voice. One of the things that I’ve thought about during this whole interaction in the past few years with bringing in the patients more to the FDA and hearing the whole FDA initiative of the patient voice, I sometimes wonder if it’s not a patient’s voice, but a patient cry to really develop clinical trials that are more humanistic, that really address the needs of the patient.

We have to understand that the clinical trials are here to serve the patients. The patients are not here to serve the clinical trials. And I frequently think that some investigators, some people in the drug development world may not realize this. We frequently see trials that I ask myself, would I go on these trials when I see a drug that has an 80% response rate and they’re comparing it to a drug that has a 10% response rate? What patient that would have that information would go on that trial? I have problems with trials that are done outside of the United States where they simply couldn’t be done in the United States because patients wouldn’t go on the drug because there’s such of a lack of equipoise with regards to the therapies that are being compared. So I really think that the patient voice may in reality be a patient cry to develop a clinical trials mechanism that is much more humanistic, that is directed toward the patient rather than a primary endpoint.

Mary Pazdur: One of many, many lessons in oncology is how to give bad news realistically and allow the person to prepare for their future, but doing it in such a way that that individual is ready to hear that information. And sometimes and often it’s a product of youth and learning, the physicians feel that weight of responsibility to be honest and share as much as they know and give the news, including the bad news and as much as they can to tell the patient as bad as it’s going to be. But there are an awful lot of people that haven’t made the adjustment to that part of the trajectory of their illness. And when he was young and we first were working together, he had many patients that would refuse to see him again, that would fire him as their physician. I don’t know if there were many, but there were enough that we had discussions about this. And it usually happened shortly after. He gave them their prognostic information about the likelihood they would be dead from their disease shortly and that there was an efficacy in terms of treatment. But we developed a term called confrontational oncology, and I think Rick learned that some people aren’t ready to hear that. And depending on where they are in terms of adjustment to their illness and the acceptance of the illness and the outcome, it’s not always in the person’s best interest to give them the facts and the statistics. And

Richard Pazdur: You really have to play that to the patient and listen to the patient. And here again, we talk about the patient voice on this kind of large scale, and there’s a patient voice in the exam room, so to speak, on an individual level. And some people just are not willing or not ready to hear this, and some patients never will be able to hear or willing to hear what the prognosis is of a particular disease. I think what Mary’s referring to is when I was really young and just beginning my first couple of years as a attending physician at Wayne State, just after finishing my medical oncology fellowship, I just wanted to make sure that everybody knew exactly where we were with this disease, the family, the patient obviously. So I was very, the only word to talk about it is blunt with exactly where we stood, and some people were just not willing to hear that and got angry at me.

In other words, they turned their anger toward the physician rather than realize that it was the situation that they had of losing control of their life, of being angry about having the disease. So many times the physician becomes the point of anger. Somebody has to be that point and you really have to play it by ear. One of the older physicians that worked in the practice had a terrific bedside manner. Dr. Viche, who was the head of medical oncology and head of the whole program at Wayne State and seeing him and he had a career of 30 or 40 years by the time I got there, really taught me really about that valuable lesson of really listening to the patient and telling the patient what they need to know versus what makes you the physician comfortable. You’re not treating yourself, you’re treating the patient. And here again on a larger basis with we were talking about the patient voice, one of the other major projects that I think we should pay more attention to is this whole issue of informed consent in the consent documents.

To say that they’re out of hand is an understatement. When a physician hands a patient, 15 or 20 pages of legalese and alternative therapies, et cetera, patients come to a doctor because they want that medical advice, the informed consent does not relinquish the physician’s responsibility to that patient. And I think that that’s very important for us to realize. And here again, people are coming to a doctor, they want that doctor to do the best thing for the patient and hence the clinical trialist, the physician, the medical oncologist must think that the trial that they are going on is the best thing for that patient. Frequently I hear, well, we don’t like the control arm, but when the patient progresses, they’ll be able to get the therapy that we think is the important therapy. And that kind of leaves a distaste in my mouth because really the therapy should be the best that you’re giving for the patients.

And one has to ask themselves, is this one of the problems that we have in low accrual to clinical trials? Either that uninteresting questions are being asked that people have no interest in participating in, or people don’t think that we’re asking and availing patients to the best available therapy or the best available therapy is not being delivered to those patients. So I think one of the issues that I would like to see, and I think should be part of the patient’s voice, is really looking at informed consent, making it simpler, making it understandable to the patient rather than just being a legal document that many physicians think exonerate themselves from a patient doctor relationship.

Mary Pazdur: The common themes that as patients going through treatment and trying to select treatment and make decisions are the issues of uncertainty, fear of the unknown and of the future, and then of making the right decision. Those all go hand in hand. I think. And I know lots of folks just become immobilized because they’re afraid they’re going to make the wrong decision. And one thing that I’ve tried to remind both of us as we’ve gone through different steps and making decisions about treatments and side effects and potential downsides of treatments is that when we’ve gathered all the information and met with the correct professionals is that we won’t look back and wonder, what if we had done something different? And so that’s been a mainstay of my outlook is not to look back, is to just say that we made the best decision we did under the circumstances and not to, I can remember vividly, we made a decision that was questionable and I said that point blank to him, whatever happens with this, we’re not going to look back and say, I wish we hadn’t done this. And it was a good lesson. I mean, it was a good exercise, but it was a good also lesson for the future.

Richard Pazdur: But I think one of the major thing that you have been always interested in is quality of life

And looking at what are the toxicities versus the benefit and having the perspective of knowing about the disease. I remember when we first got the diagnosis three years ago, I was talking to a very good friend of mine who’s a lawyer, and I was telling him that having Mary have this disease and having worked with her with similar patients, et cetera, and having had patients throughout my professional career with this was like being in a book that you know the entire story and how it’s going to end, but there are chapters perhaps that will take a little turn that you did not expect or that you missed on the first reading. But having the knowledge of the disease of the prognosis is something that is different from other people. And it’s not just the knowledge, it’s the personal experience of dealing with other people that have had the disease.

And I think that that makes physicians different from perhaps basic scientists or somebody that reads about the prognosis. They have that intimate experience with a patient that they’ve treated that has had a similar disease, so they know what the story is as it evolves and as it unfolds. Now, naturally there are different turns here of events with each individual patient, but that I think earmarks our experience, which makes it much different from maybe a lawyer that has this or another professional or somebody else that has a disease such as ovarian cancer. They haven’t had that intimate experience. Yes, you could go to the internet and look up what the prognosis is. Yes, you could read the toxicities. Yes, you could read the effects of the drug on overall survival or response rates, but you really don’t have that intimate relationship of a previous patient having it and having had that experience with that patient, which makes it a bit different.

I also remember in my first initial handling of the disease, I had spoken to her gynecological oncologist that did the surgery, so I was very familiar with the surgical procedure and what he found, and then when you brought your medical records home and I looked at the PATH report and I looked at the surgery, I just couldn’t read them. I started reading them and the PATH report had metastatic adenocarcinoma 15, 20 times on three different pages, and it was just like rubbing salt in a wound. Yes, I knew it, but did I need to see it over and over and over and over again. I think the PATH report had about five pages and the word metastatic adenocarcinoma appearing 50 or 60 times in that space. Likewise with the operative report, I started reading it and because he had told me what he had found, it being in writing had so much more poignancy and so much more of an emotional impact. I just put it back down and to this date, I haven’t read the PATH report and I haven’t read the operative report. I know what they say. I just don’t need it to be in my face, so to speak.

Katie Goldberg: The Cancer History Project is an initiative of The Cancer Letter, the leading source for information on the issues that shape oncology since 1973. 

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