A Seat at the Table: A Research Advocate’s Journey
Summary: The story of one patient advocate and author who moved beyond her personal experience with breast cancer to focus on helping women with metastatic disease, which in turn has led to her further training and involvement with drug development, regulatory issues and other research issues.
Keywords: Participatory medicine, patient advocacy, breast cancer.
Citation: Mayer M. A seat at the table: a research advocate’s journey. J Participat Med. 2009(Oct);1(1):e14.
Published: October 21, 2009.
Competing Interests: The author has declared that no competing interests exist.
When trained advocates serve on panels reviewing research proposals, on steering committees or data safety monitoring boards for clinical trials, or any of the many other research-related efforts we undertake, we’re often approached during a meeting break by a doctor or scientist commenting on how knowledgeable we are. As a newly minted advocate, thrilled to have a seat at the table, it was flattering at first to hear these compliments. Then I began to ask myself: why are they so surprised? What kinds of low expectations do they have of advocates?
In reality, there are many advocate perspectives, strategies, and levels of expertise. We are trained and untrained, working within the system and outside the system. In the world of cancer drug development that I am part of, the most insistent advocate voices focus on the need to get new drugs approved as quickly as possible and obtain early access for desperately ill and dying patients. We speak of hope, of cure, of extending life. Randomized trials and rigorous requirements for drug approval are frequently seen as the enemy—unneeded and bureaucratic red tape imposed by an uncaring FDA. Compelling voices telling heartrending stories tend to capture more attention, at least from the media, than the voices of advocates like me who seek to balance immediate needs with larger questions of evidence, ethics, and systemic change. Taking a longer view, we work for what we hope will benefit all patients, now and in the future.
Whatever our differences in approach and values, whatever our training, for each of us, advocacy began in the same place: close to home, with the diagnosis of life-threatening disease in ourselves or in someone dear to us. Starting as patients or family members of patients reeling with unwelcome news, we all sought a way to come to terms with the frightening unknown, the bewildering choices of providers and treatments. As our abruptly changed lives spiraled out of control, we found help through information, communication, and affiliation. The urgency to know and understand what we were dealing with, to share with others similarly afflicted, and to solicit their advice and insight marked our lives in treatment and often long afterwards. As our bodies healed from the assaults of cancer treatment, we began to respond to the needs of others, discovering that we had something to offer, a knowledge that was hard won and deeply felt, and that somehow in that sharing we could both help and be helped. We joined groups and formed groups and sometimes organizations, moving beyond isolation to community.
From that point our paths diverge, as do our training, interests, and choices. While most cancer patients return to their prior lives and occupations, those of us who’ve become full time advocates choose not to. We see an unmet need, a path forward, or perhaps even a road not taken at an earlier point in our lives. But it’s presumptuous to speak for others, and meaning is diluted by generalities. So I will focus on my advocacy, my path.
Looking back, one can always follow the thread of one’s life, where this inevitably led to that. Living forward, however, the way seemed far less clear. Coming of age in the Women’s Movement, working as a counselor in community mental health had prepared the soil, but my advocacy only really began following the germinal event of my own stage II breast cancer diagnosis 20 years ago. As I recovered from surgery and chemotherapy, I felt moved to share what I’d learned with other women, helping them as I had been helped. I joined a support group. I talked with newly diagnosed women on the telephone, as others had talked to me. I began to write about breast cancer. Beginning with what had happened to me, I described my own experiences and those of my support group, and eventually shaped those personal essays into a memoir I entitled Examining Myself: One Woman’s Story of Breast Cancer Treatment and Recovery.
As it became clear to me how much the process of writing had helped me to come to terms with having cancer, I began to offer daylong writing workshops for anyone coping with life-threatening illness.
In the early 1990s, on one of the Internet’s first online breast cancer communities, over 1,000 breast cancer patients and their families shared stories of their experiences, asking and answering questions. A common theme was our fear of recurrence. Over time, for some in that community that fear became reality. Some of these women stayed on to share the roller coaster rides of treatment failures and disease progression. Most quietly faded away, not wanting to upset the others, until a daughter or husband would post a notice they had died. These women found October (Breast Cancer Awareness Month) particularly difficult. Why was all the attention focused on mammography screening and coping with early breast cancer? Where would their voices be welcome? As I witnessed this predicament, the seed for a second breast cancer book began to germinate, and a new focus for my advocacy was born.
Less than two years later, after interviewing 40 women and men living with metastatic breast cancer who contributed their reflections and experiences, Advanced Breast Cancer: Living with Metastatic Disease was published, the first guide for patients with metastatic breast cancer, the cause of over 40,000 deaths each year. Patients and families began to turn to me for advice, to ask about treatments. I soon realized that I needed to learn about breast oncology in far more depth if I wanted to help women understand their treatment options and learn about the disease—actually several distinct diseases, as science was beginning to tell us. I did not yet grasp the importance of advocating for this neglected population in the larger realms of health policy and research.
By that time, I had been a member for several years of the National Breast Cancer Coalition (NBCC), which had lobbied Congress for more research funding, then worked to ensure those research dollars were well spent by establishing and fully participating in the innovative Department of Defense Breast Cancer Research Program (DOD BCRP), which has awarded $2.2 billion in research grants since its inception in 2002.
For NBCC, advocate involvement did not end there. Long before the DOD BCRP was established, it was clear that if advocates wanted a seat at the table where research decisions were being made—and to participate fully in making those decisions—we had to understand the science. Staffed by leaders in their field, NBCC’s science training program for advocates, Project LEAD, was designed to answer that need by offering advocates an in-depth immersion in epidemiology, molecular biology, clinical trials, and evidence-based healthcare, building a base for ongoing learning. Taking Project LEAD helped me to see the larger issues in breast cancer research and to understand the full range of the research enterprise, from preclinical work in the lab and with animal models, through translational science, to clinical trials. I felt empowered to begin attending the major cancer research conferences and to follow breast cancer research throughout the year.
Reviewing grant proposals for the California Breast Cancer Research Program, I have to admit I found the basic science challenging. I wondered what I could possibly add to what the scientists would have to say. I spent hours reading and rereading each proposal that first year. Once seated around the big conference table, however, hearing the primary and secondary reviewers evaluate each submission and explain the science to other reviewers outside of their field, I realized that I’d actually understood far more than I thought. I listened to the more seasoned advocates speak of the implications for patient care, and saw how the scientists valued that perspective and how integral it was to the process as a whole.
But it was clinical research that interested me above all. For women with metastatic breast cancer, treatments that extend life offer hope. Beyond making public their hitherto untold stories, and connecting them with one another, I thought perhaps I could help by focusing on drug development and regulatory policy. In 2001, I applied to the Office of Special Health Issues at the FDA to become a Patient Representative and Consultant.
Serving on FDA advisory committees, I’ve tried hard since then to comprehend and integrate the evidence that I am called upon to review, a task that can be daunting. As a Patient Representative, I participate in discussions and vote to recommend that FDA approve or not approve the products (drug, biologicals, or devices) under discussion. I am always thinking of the women I work with and their families. I try also to think of all the patients I don’t know and of all those who will be seeking treatment five or ten years from now. Should we wait for large enough studies to provide conclusive evidence or take a chance that data will eventually confirm what we all hope to be true? Do the studies measure outcomes that actually help patients? Should we heed the speakers in the Open Public Hearing (a part of every FDA advisory committee meeting) and get the proposed drug to market at the earliest possible moment, or are there imperatives to wait for longer-term safety and efficacy data? What about extenuating circumstances where alternative treatments do not exist? These are tough questions with no easy answers.
During the last decade, as patient involvement in research has become more widely accepted, opportunities for trained advocates have grown by leaps and bounds. In that time, I’ve had many opportunities to bring a patient perspective to the table, working with industry and research groups to offer feedback on clinical trial design, serving on data monitoring committees, on steering committees for registry studies.
The DOD BCRP requires researchers who apply for grants to envision and create a role for trained advocates in their studies. For the past several years, I’ve been fortunate to work as an advocate for a DOD-funded Center of Excellence that is studying brain metastases of breast cancer, directed by a molecular biologist from the NCI who values advocate involvement highly. This Center of Excellence is comprised of experts from many disciplines and several institutions working together on increasingly common, hitherto neglected problems of grave concern. As advocates, our expertise when it comes to patient issues is welcomed by our colleagues. In a scientific area where the need is so great and the stakes are so high, the warmth and mutual respect of this group of researchers, doctors, and advocates has become deeply meaningful to me.
In drug development research, when attending scientific conferences, it is impossible for an advocate—at least for this advocate—not to be acutely aware of the ways in which financial incentives shape both the conduct and outcomes of research. In an age when clever marketing and clinical trials are sometimes so intertwined as to be indistinguishable, trained advocates would do well to question the source of data and the design and conduct of trials. But it’s hard to maintain a critical perspective, to be the skeptic when others are so hopeful about this or that promising new agent; it’s far easier to go along, to believe the hype. Not only do we fervently wish for effective, nontoxic treatments, but many advocacy organizations depend at least in part on industry funding. I would never fault my advocate colleagues who must depend upon this funding for the good work they do. Although I occasionally accept travel reimbursements, I try, for the sake of my work with the FDA, to avoid conflicts of interest. Advocates are no more immune to influence and loss of critical perspective than anyone else supported by industry. Trying to maintain my ability to question and challenge, I’ve strengthened my ties with NBCC and the Cochrane Collaboration, both of whom hold independence of thought and critical appraisal in high esteem. In developing a free 6-module web course on evidence-based healthcare for the U.S. Cochrane Center, I did my best to reinforce these values and impart them to other advocates.
I’ve come to believe that maintaining high standards in research leads to better treatments and is ultimately better for patients. While some may see this as a disincentive for innovation, a barrier to early access, I want not more treatments of unknown value, but better treatments. I believe equal access for all women is more important than early access for a few. I worry about the thousands of poor and uninsured women who die disproportionately and at younger ages, suffering from this disease without access to even standard approved care. In the public policy discourse, their voices too often go unheeded and their deaths unmourned.
Every advocate has a story like mine—a path carved by crisis and fortuitous circumstance, by passion for knowledge and a desire to serve. For whatever reason, we’ve chosen to embrace what was once devastating, and by helping others, transcend the merely personal. Our story is a story of choice, participation, and empowerment. It is a story of control regained, of helplessness vanquished by knowledge, of despair conquered by community. As research advocates, we claim as partners the scientists and physicians whose work inspires us and gives us all hope.
-  Mayer M. Examining Myself: One Woman’s Story of Breast Cancer Treatment and Recovery. London: Faber & Faber; 1993. ↩
-  Mayer M. Advanced Breast Cancer: Living with Metastatic Disease. Sebastopol, CA: Patient-Centered Guides, O’Reilly & Associates; 1997. ↩
-  www.BrainMetsBC.org ↩
-  Understanding Evidence-Based Healthcare: A Foundation for Action. US Cochrane Center online course. Accessed October 12, 2009. ↩
Copyright: © 2009 Musa Mayer. Published here under license by The Journal of Participatory Medicine. Copyright for this article is retained by the author(s), with first publication rights granted to the Journal of Participatory Medicine. All journal content, except where otherwise noted, is licensed under a Creative Commons Attribution 3.0 License. By virtue of their appearance in this open-access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.