Patient Advocacy in Research: Merely an Afterthought? : The Patient: Patient-Centered Outcomes Research

HELPA8FC549B4C08CBC78-main(I found this article very interesting for all of us who are patient advocates. It was written by Musa Mayer of advancedbc.org.)

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In 20 years of breast cancer advocacy, I’ve witnessed major changes in attitude toward advocates on the part of basic researchers, clinical investigators, and others involved with the science of the disease.

Not so long ago, even a seat at the table – much less a vote – was hard to come by. Advocate presence was met with puzzlement, if not outright resistance. How could we possibly understand the complex scientific issues under discussion? What, exactly, was our expertise?

Within the space of a very few years – not coincidentally with the increase in advocate-driven research funding – waves of change began to wash away this resistance. Appreciation for our fundraising efforts, mixed with grudging recognition that people who actually live with a disease have useful perspectives, were contributing factors. In the wake of the 1970s and the women’s health movement, medical paternalism was relaxing its grip, and a new generation embraced the patient-doctor relationship as a partnership of equals. In the late 1980s, AIDS activists demonstrated the power of organized pressure on access and policy when lives were at stake. In the early 1990s, the Internet began to connect and empower a steady stream of newly informed patients.

It was in just such an online community, the first breast cancer mailing list, that my own advocacy was born, from a desire to ‘pay forward’ the information and support offered me when I was diagnosed. What began as a small, personal ripple expanded outwards as I recovered from treatment and moved from helping the members of my support group to reaching out to women in emerging organizations and communities, then to all women with breast cancer.

I joined with other advocates. Not satisfied with offering only emotional support, we called for better, less toxic treatments available to everyone. The standard of care seemed harsh and crude. Some referred to chemotherapy, surgery, and radiation as ‘poison, slash, and burn.’ Rejecting the metaphors of war, we called for gentler, targeted therapies with less ‘collateral damage.’ To accomplish this, more and better research was needed.

We were not content with just handing over the research funds. We looked with suspicion at the minor progress made in Nixon’s war on cancer1 and began to raise questions about the direction of cancer research, and the lack of collaboration and support for novel ideas. Funded through the efforts of advocates, programs such as the US Department of Defense Breast Cancer Research Program[1] were born.

In the years since, the presence of advocates has become commonplace in the world of cancer research. We sit on US FDA advisory committees as voting members, on Institutional Review Boards (IRBs), and data safety monitoring boards for clinical trials. We serve on Specialized Programs of Research Excellence (SPOREs) and in the Cooperative Groups.2 We rate grant proposals in study sections, and help determine research priorities. We speak at conferences, and are co-authors of papers, posters, and abstracts. We offer input to industry about trial design and enrolment, drug safety, and access to new therapies in the pipeline. Our activism runs both ways. By translating what we learn of the research back to the patients we serve, we help them to make better, more informed treatment decisions.

In preparing this article, I shared my concerns with Patient Advocates in Research (PAIR), a long-standing mailing list. The flood of responses spoke candidly about our difficulties, as well as our roles and strengths.

Several emphasized the important role we play in encouraging collaboration rather than competition among researchers, helping them to concentrate more on meaningful goals, and less on professional and career concerns. This is no easy task. It is the nature of research to “meander from one disparate place to another,” explains Deborah Collyar, President and co-founder of the PAIR mailing list, “which keeps the focus on the individual PIs [Principle Investigators] who compete with each other for grants. It’s like a game of musical chairs.” To make an impact, she suggests, “We have to speak up, and remind them to act like big boys and girls to get something done.”

Colorectal cancer advocate Kate Murphy agrees, “Research can answer interesting but irrelevant questions, provide statistically significant but clinically insignificant results … but in the end, does it matter to patients? Researchers can lose sight of the real goals, and we can keep them honest.”

The very presence of advocates can make a difference. “Not only does my face and my story inject reality into the cancer research enterprise, it seems to add some sense of urgency,” says Murphy. “We need to get the job done now without quibbling and without egos.”

Sometimes, advocates are the only ones who bring a real-world perspective to research discussions, says breast cancer advocate Cheryl Jernigan. “We’ve got to get beyond incremental steps that simply add to already unsustainable growing healthcare costs, to research that makes a substantial difference in the length and quality of life, that will be accessible in the community setting and not break the bank.”

An education in the language and methods of science is critical. Trained advocates challenge biases researchers may have had, by presenting themselves as thoughtful and intelligent peers and colleagues, well versed in the research process. But still they are underutilized at times, and unsure of their roles. “Most researchers who have engaged with us seem to really appreciate our involvement,” says Jernigan, “but don’t really know when, where, or how to engage us, and we don’t always know what it is we can do.”

Joyce Graff, advocate for patients with Von Hippel-Lindau (VHL) disease, a genetic blood vessel malformation, has experienced little support from the SPORE on which she serves: “Periodically, they will turn to me in a meeting and ask whether a proposed clinical trial design will appeal to patients.” But her opinion is solicited only after trial proposals and informed consent documents have been submitted to the IRB.

Being invited to endorse, or recruit for, research studies without participating in their creation is a familiar complaint. I’m not alone in having been invited to join steering committees for registries and clinical trials only after the important initial decisions are made. Substantive roles for advocates can be hard to come by.

But when we are brought in early in the process, we can make a genuine contribution, Collyar feels, “We help them think about how they will actually implement the trial and how to reach as broad an audience as possible, ethnically speaking, as well as eliminating bogus eligibility requirements.”

Many of us have experienced last-minute calls and emails from researchers a day or two before grant proposals are due. Clearly, the PI has discovered that advocate involvement is required and is scrambling to find someone. We become an obstacle to be surmounted, not a resource to be used.

I’ve been fortunate enough to have also had the opposite experience. Involved in a major research grant to study brain metastases in breast cancer,[2] my input, and that of other advocates, has been invited and welcomed at all stages of planning and implementation, with the complete confidence and trust of an enlightened PI who has worked with advocates for years.

Central to drug development, regulatory policy is also of intense interest to advocates. I first served as a voting Patient Representative[3] on the FDA’s Oncologic Drugs Advisory Committee a decade ago. At the open public hearings, diverse advocacy perspectives are on display, ranging from passionate pleas for access to calls for tightened regulations. While some view the agency as a bureaucratic and unfeeling barrier to access, the FDA’s mandate always made sense to me. I too was concerned about risks and benefits of new treatments, about levels of evidence and adequate proof of safety and efficacy. Having witnessed the rise and fall of bone marrow transplants in breast cancer, I knew how catastrophic the premature adoption of unproven therapies could be.

As a graduate of Project LEAD, the National Breast Cancer Coalition’s science training course,[4] I fervently believed that advocates needed to understand the research process, and to be able to look beyond immediate needs to what would offer current and future benefit for all patients. To that end, I co-developed a free, online training curriculum for the US Cochrane Center in evidence-based healthcare specifically for advocates.[5]

If advocates only understood the research process, I reasoned, they would surely take more nuanced, thoughtful positions on issues of evidence and access. But reason trumps emotion only rarely when lives are at stake, and desperation fuels inflated hopes for treatment efficacy. Described by ethicist Rebecca Dresser as “advocacy’s emphasis on the bright side of medical research,”[6] this unwarranted optimism has the potential to increase demand for unproven treatments, and to make it harder to recruit definitive studies. Patient bitterness and public disillusionment with the research enterprise are sure to follow.

Science is hard. “Most of our experiments fail,” a researcher I work with reminded me recently. For advocates, removing the blinders of wishful thinking, replacing them with a clear-eyed, cautious view of scientific research, is sobering but necessary. To do so while maintaining a hopeful stance with the patient communities we represent is harder still. But then, no one promised the truth would be easy.

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References

1. Congressionally Directed Medical Research Programs, Department of Defense. Breast Cancer Research Program [online]. Available from URL: http://cdmrp.army.mil/bcrp/default.shtml [Accessed 2011 Jan 30]
2. Center of Excellence, DoD Breast Cancer Research Program [online]. Available from URL: http://brainmetsbc.org/en/content/about-center-excellence [Accessed 2011 Jan 30]
3. US FDA. Patient Representative Program [online]. Available from URL: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates [Accessed 2011 Jan 30]
4. National Breast Cancer Coalition. Project LEAD [online]. Available from URL: http://www.stopbreastcancer.org/learn/project-lead/vision [Accessed 2011 Jan 30]
5. Mayer M, Dickersin K. Understanding evidence-based healthcare: a foundation for action. US Cochrane Center [online]. Available from URL: http://us.cochrane.org/understanding-evidence-based-healthcare-foundation-action [Accessed 2011 Jan 30]
6. Dresser R. When science offers salvation: patient advocacy and research ethics. New York: Oxford University Press, 2001: 153

: Patient-Centered Outcomes Research:

1 June 2011 – Volume 4 – Issue 2 – pp 69-71
doi: 10.2165/11590710-000000000-00000
Editorial

Author Information

 AdvancedBC.org, New York, USA

Correspondence: Ms Musa Mayer, MS, AdvancedBC.org, 250 W 82nd Street, Apt #42, New York, NY 10024, USA.

E-mail: musa@echonyc.com

See on adisonline.com

To Pink or Not to Pink

Hypnotically Pink for the Cure (1488505615)
Hypnotically Pink for the Cure (1488505615) (Photo credit: Wikipedia)

This is a very tough question. I love pink. I always have loved pink. I still want to love pink. Surely we don’t need to destroy the beauty of the color pink because of “pinkwashing”.

I first heard the word from Gayle Sulik who I met at a luncheon during the NBCC May 2011  Summit and Lobby Day in Washington DC. Gayle wrote a fascinating book called “Pink Ribbon Blues” loaded with lots of great thought-provoking revelations about pinkwashing. I also heard about it from Breast Cancer Action (www.bcaction.org). They are a wonderful organization that really looks at important issues like the effect on the environment, carcinogens, and cause marketing have on breast cancer. They have a documentary well worth seeing called “Pink Ribbons, Inc.“, directed by Lea Pool, which has started playing in major cities.

I am also aware that the pink put us on some type of map perceiving breast cancer. However, selling products that contribute to causing cancer, while consumers think they are giving money to help cancer,  is an example of pinkwashing. When I saw a pink ribbon on the big pink round Kentucky fried cup, there was something wrong with that picture.

We know this is not a happy pink color disease. At the same time we have to take back the pink’s past and present visual connection to improve so many issues related to breast cancer.  I wish instead of pointing a finger of  blame we could accept the pink as a starting voice about breast cancer. Blaming the color pink will get breast cancer advocacy nowhere.

Maybe on some level it did enter my subconscious when I volunteered for Komen, but I ignored it at the time. I remember clearly right before my close friend Lila started to show signs of her breast cancer’s rapid disease progression, I told her about the Komen perfume. While holding on to her walker with her wig on, Lila thought that there was something wrong with Komen selling perfume with carcinogens in it to raise funds for breast cancer. It was also insulting to anyone doing chemo since the smell of perfume has a terrible effect on most patients during their chemotherapy treatment. But if Lila heard about the “Planned Parenthood” debacle, she would have been quite upset with the Komen brand.

Politics and giving are best not connected. My facts and figures showed that Komen gave the most money to breast cancer research, although I do wonder at what cost. I could stay feeling betrayed by the Komen brand, but it is completely separate from the color pink.

What I am saying is we have to make peace with the pink before us. Being at war within the community is never a good idea. There are so many instances where people’s hearts and minds were in the right place with the pink, and it is not fair to dismiss the association because of political hypocrisy. At the same time we can look at some of the advertising and be aware when someone is selling us something that goes against what we are trying to do.

The simple fact is we want a vaccine to prevent breast cancer (all cancers would make me even happier), prevent metastasis, and reverse metastasis once it has happened.

Whether that means making peace with the pink or not, we must focus our energies in the same place by recognizing what we have in common.  We all agree that we want to end this disease. Let us take back the color pink, think and remember that we are all in this fight together.

Why I Care so much about Breast Cancer Advocacy

breast cancer research

I am finally ready to start writing about how much breast cancer has made an impact on my life. I kept a journal for seven and a half years writing monthly about what was happening around me after finding out I had breast cancer. There is so much work I have yet to do to like working with other patient advocates to see an end to this disease.  You can also read a condensed version about my history with breast cancer in my blog.

If you are reading this, you probably have had breast cancer, still have breast cancer, have a family history of breast cancer, or have been affected by the disease. If you’re a survivor, you know this disease is not just a sea of beautiful pink. I wish it were because I love the color pink. It’s such a happy color. In this blog I am not going to get in to the “pink-washing” of breast cancer, but anyone touched by the disease knows it’s not a pretty picture.

I was fortunate in joining the National Breast Cancer Coalition (NBCC) and if you haven’t heard about them you should go to http://www.stopbreastcancer.org (after you read my blog), and see what they are all about. I am so inspired by the president Fran Visco and her vision of seeing an end to breast cancer by 2020.  The NBCC also realizes that to help eradicate breast cancer, patient advocates need to be well educated about the disease.

The NBCC has special classes to train new advocates. I am proud to say that I am a LEAD Graduate where I learned so much from incredibly well-respected doctors in the medical community and speakers including people who work at the National Cancer Institute. In 2011, I took the Project LEAD Workshop which consisted of six days learning about he science of breast cancer, Rna, DNA, assays, statistics, pathology, chemo regimens, injecting mice with breast cancer, fat glands, clinical trials, radiation, advocacy, how the news gets it wrong, what is myth and what is fact, the future of breast cancer, the Artemis Project, (where scientists, doctors, researchers, and patient advocates are working on a vaccine to prevent breast cancer), genetics, types of breast cancer, tests, questioning  what you read or hear about breast cancer, health care, advocacy, and so much more. They gave us thick notebooks of articles, abstracts, definitions, copies of slide presentations, and more paper to take notes. It was so exciting to speak after the lectures with people like Dr. Diane Palmieri from the National Cancer Institute and be able to talk to someone who is working in the lab to help end breast cancer since I have been physically going through treatment of the disease. We even had a visit from Dr. Susan Love who wrote  “Dr Susan Loves Breast Book” which most breast cancer survivors consider the Breast Cancer Bible. She is fascinating to speak with and she is so knowledgeable about breast cancer.

The NBCC helped me to become an educated advocate learning as much as possible about breast cancer. As a result I attended the Asco Breast Cancer Symposium and two San Antonio Breast Cancer Symposiums where leading doctors in the field talk about the science of breast cancer, clinical trials, abstracts, patient cases, and so much more. I was also able to go to Washington DC two years in a row with the NBCC to meet with congressional members from my state, to get money appropriated by the Department of Defense, and sign a congressional letter talking about ending breast cancer in 2020.  I will talk about this in much more detail in another blog. Because I have had breast cancer, know other breast cancer survivors, watched my best friend die of breast cancer,  have other friends who are either going through primary treatment or have breast cancer that has metastasized, I am passionate about making advocates4breastcancer.org an organization that will help current patient’s lives and help bring an end to breast cancer.

To increase our visibility to other breast cancer patients and advocates, we are in the process of developing a web site named advocatess4breastcancer.org or a4bc.org. Watching special friends who are experiencing breast cancer that has metastasized  (or mets as we call it, which means the cancer has spread to other parts of their bodies), is very difficult. These are the people we want to help as much as we can. The deadline is too late for them. All they have are toxic chemo drugs that can for a time slow the spread of the disease and possibly even get rid of tumors, but once the cancer has spread it most likely will come back.

Our non-profit is devoted to making sure that they are not “the forgotten ones”. At this time no one  knows how to reverse mets, nor how to destroy mets so they do not return.  Yes, some chemo drugs can shrink tumors and they can hold them at bay, but they can’t erase them forever without them coming back. Our goal is to do everything in our power to help discover and fund research that can destroy mets permanently and end breast cancer.

To read more about the organization, please click on the “About Us” tab.

You have Breast Cancer

I am a breast cancer survivor. I heard the words “you have breast cancer” over the phone from my gynecologist on December 15, 2004. I had a sentinel node biopsy in January with a lumpectomy and the first node was positive. I will never forget the way my very famous breast surgeon told me that I had to do chemo. He said, “You are going to lose all your hair” in a smiling manner. The news did not go over well with me. I had an axillary dissection to see if there was any other lymph node involvement and luckily there wasn’t.

I went on the Internet and studied every chemo regimen before I met with my oncologist. I suggested that I wanted CMF since they were chemo drugs that would not make all of my hair fall out, only hair thinning. She recommended that I do “dose-dense” adriamyacin with cytoxin once every 2 weeks for 4 rounds, and then taxol once every two weeks for another four rounds. I asked her “if I believe the CMF will work over the regimen you are suggesting would you give me that for my chemo”?  She said “yes, but I really think the dose-dense is the best regimen for your particular case.” I adored her for recognizing that I was in control of my medical decisions. Because she didn’t talk down to me, I felt very comfortable with her.

My pathology turned out to be estrogen positive, progesterone negative, and her2-neu(negative). This meant that I could later take an estrogen blocker and I did not over express the gene meaning the cells did not multiply rapidly and I would not benefit or need a drug like herceptin(tratusunab). Lila’s pathology was estrogen negative, progesterone, negative, and her2neu (negative). This meant that she was triple negative and would not benefit from an estrogen blocker, or a drug like herceptin. Her pathology has a higher degree of recurrence because there is less to fight it with. Her pathology also is prevalent among the African American community, although she was half chinese and half All American.

When I realized I had to do chemo I joined a support group at UCLA Simms/Mann that was awesome. It met every Thursday morning and it was for women going through breast cancer primary treatment. There I met a friend Lila, who also went to the same oncology office that I went to with another doctor. A few days after the first meeting of the group, I saw her at the oncology office and I offered her a ride home. She was further along in her treatment and had already lost her hair. We became instant friends.

I started chemo in February after doing the BRCA 1 and BRCA2 testing and found out that I was negative. The first round went great, but after that it was downhill the rest of the way. The day I lost my hair I called my friend Lila from the group and we talked on the phone all day as the strands of hair kept coming out of my head. It turns out we had a lot in common and I was so grateful to her for staying with me during that frightening day. She knew because she saw how thick and long my hair was and that losing it was not going to go over well.

I started using all the medications to stop the nausea and vomiting. Eventually they all stopped working, even the expensive kytril. I lost 15 pounds and I couldn’t keep very much food down. Lila and I went out to eat a lot and she also had stomach issues, so we really were able to help each other. When I got to my last chemo I kept running to the bathroom with my IV and getting sick.

After chemo I did 7 weeks of radiation going 4-5 times a week on weekdays depending on holidays- equal to 35 treatments. I was still nauseous during radiation. Meanwhile, Lila and I continued getting together a lot to help each other with side effects and talking about breast cancer.

Because Lila was ahead of me in finishing her treatments, she went into the next group at UCLA, which met once a month called Looking Ahead. She told me that the group was only taking one more person and that I needed to hurry to get in to the group. It is an amazing group that meets once a month. After a year and a half of my being in the group, we left UCLA so others could start a group, and we still meet once a month at each others homes. I also took the real estate test, passed and got a great job at the number one office in Beverly Hills.

Six months after my treatment was over I had a suspicious lump that required a biopsy. When the famous doctor walked into the room I was smiling and he said to me “How come you already know the results”? I knew I was fine since I had just finished treatment and it was too soon for a problem.

In February 2007 I had my follow-up MRI.  When it was time for the results my doctor was away. I insisted that the doctor on call phone me. I had decided that cancer was not going to kill me but waiting for test results would. He told me there was a suspicious area on my left breast and I needed to come in for a biopsy guided by an ultrasound.

My doctor did an ultrasound and mammogram to see if he could find the suspicious spot on those tests, and he couldn’t. I thought I was in the clear. After all this was only a year and a half after I finished my last treatment. The doctor said, “Just in case, I am going to order an MRI biopsy to be sure”. He ordered the test. I asked the person who performed the test how many he had done and he said about 100. I realized how lucky I was to live in LA where we are on the cutting edge of technology.

After my usual two-hour wait for the doctor I got into the room and waited another half hour for him to come in. When he walked into the room to give me the results, I had the same smile on my face. He did not have a smile. Instead I heard those words again. He said, “It’s malignent. It’s cancer. It’s breast cancer again”. My first question was did I need to do chemo and he said that I didn’t. At least I didn’t hear “You are going to lose all of your hair again”. This was a local recurrence. He told me that I needed a mastectomy since it was in the same breast and that it was my choice if I did a bilateral or just one breast. He gave me three business cards to plastic surgeons that he worked with, plus he made an appointment with one of them who could see me immediately.

The first surgeon was going to do a tram flap (getting tissue from my stomach), and said it would cost $30,000 over my insurance. The second doctor charged me $500 for the consultation & recommended a double lat flap. He further explained that I would not be happy with the results. Then he had his assistant give me an estimate of $80,000 over the costs of the insurance for the procedure. One thing I was sure that he was right about-After spending $80,000 plus the $10,000 over the insurance I had to give the oncology breast surgeon to remove the breast tissue, I would not be happy with the results.

The third surgeon was a woman who accepted my insurance and normal co pays for the procedure. She said that she could use tissue expanders first to stretch the skin and then put implants in. I told her how important it was to me to have the c cup that I always had because I wanted all of my clothes to fit. By that time I had gained much of my weight back. I obviously chose the third surgeon.

I decided to do a bilateral mastectomy since I was having so many suspicious tests requiring biopsies, and my breasts were very dense. I felt that it was too soon for me to have a recurrence after my treatments and if my body was determined to make cancer cells in my breasts, I needed to pay attention to what my body was doing and make the right decision for me.

My friend Lila went with me for my surgery and got the doctor’s report as well as called my family in Tennessee. I also suggested she go back to her surgeon who was the first one I saw the day my surgeon told me about the second cancer and I went for an opinion. Since she was not happy with her results of her lat flap plastic surgery, I felt she should tell the plastic surgeon and give him another chance. He agreed that it was not a great job and said he would not charge her over the insurance to improve her breasts. I went with her for her surgery and after that we both always went with each other when we had surgery.

Without too much detail in this blog entry, the plastic surgery left me with barely a “b” cup and the radiated breast failed miserably. It was not the surgeon’s fault since this really was not her surgical specialty and she did not do flaps. I am so grateful to my oncology breast surgeon for finding my recurrence so early but I wish he told me that I was going to have major problems with my radiated breast. I ended up having 8 surgeries total counting my original surgery and finally found an amazing plastic surgeon that accepts my insurance in LA. If anyone ever needs a referral I will be happy to speak with you about her. She fixed a really botched up job by another surgeon who did a lat flap that also failed on my radiated breast.

My friend Lila also had a recurrence in February 2009. It  was a distant recurrence that had metastasized into her skin and bones, I am sorry to tell you she died on January 6th, 2012.

I have learned so much about breast cancer since Lila and I were diagnosed with breast cancer plus I went to many symposiums about breast cancer. I also learned a great deal from the National Breast Cancer Coalition (NBCC at http://www.stopbreastcancer.org), and I am proud to say that I am a LEAD Graduate.

All of this motivated me to start my non- profit dedicated to research, education, patients rights, and ending breast cancer. You will hear more about what I am doing to make this company that I have created a reality, in other blogs.

To learn more about Advocates for Breast Cancer click on “About A4BC.”

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