Category Archives: Advocacy

Is There Sex After Cancer?

MedPage Today (1/26, Harrison) reports that while it is common “for women with cancer to have a number of unique concerns about sexual function following diagnosis and treatment…it is unlikely that there is a simple algorithm to address those concerns.” For instance, “the Scientific Network on Female Sexual Health and Cancer used a web-based survey to gather information about physical examination practices across a diversity of providers and received 34 responses, according to Stacy Tessler Lindau, MD…lead author of a study published in CA: A Cancer Journal for Clinicians.” The researchers wrote, “The routine gynecologic examination performed in the general gynecology or the gynecology oncology setting typically does not include all the elements needed to thoroughly assess a patient with sexual function concerns.”

Some Tumor Samples In MATCH Trial Found To Be Low-Quality

This article leads in with “Shoddy biopsies deny cancer patients a shot at personalized treatment”. Biopsy samples taken from patients with advanced cancer, were collected by doctors in hundreds of clinics nationwide. When researchers checked them, they found as many as 1 in 5 didn’t have enough malignant cells to analyze, in most cases because the biopsy had been poorly done. This glitch raises troubling questions about the new era of precision medicine. The article goes on to report “biopsies done in rural or community centers were more likely to be shoddy”. Those patients’ tumors couldn’t be analyzed and they couldn’t be matched with medicines targeted at their specific genetic mutations. And that suggests that access to the most advanced, customized cancer treatments might be highly unequal — and dependent on the quality of the local doctors performing biopsies. Perhaps “shoddy” is a strong word when trying to balance the need of being minimally invasive to arrive at a tissue diagnosis versus having enough tissue/tumor cells for additional molecular analysis.  Larger biopsies carry the risk of more potential complications while less invasive procedures that may be sufficient for accurate grading/staging may be insufficient for downstream analysis.

STAT reported that the MATCH trial, launched last year by the National Cancer Institute, “has run into an unexpected roadblock: Many of the tumor samples aren’t robust enough to be put through genetic analysis.” According to STAT, the issue “raises troubling questions about the new era of precision medicine.” The article pointed out that though interventional radiologists usually aim to take as small a biopsy as possible to avoid infection and other risks, “only larger and more invasive biopsies can provide the type of genetic information needed for personalizing therapy.” Dr. Michael Thompson, incoming chair of the Community Research Forum Council at the American Society of Clinical Oncology, said, “You have these competing issues of trying to minimize toxicity from the procedure and trying to get optimal tissue.”

“Personalized medicine” for years to come will be forced to deal with “diagnostically” suitable tissue samples versus “more tissue for molecular analysis”.

Read more here.

Put Advocates in Charge of the Breast Cancer Research Agenda

Courtesy of Fran Visco, President, National Breast Cancer Coalition – reposted from Huffington Post:

Across the country, people run, walk, dine out, buy “stuff” and write checks to support breast cancer research. All of this is great. But what exactly is “breast cancer research?” Where does the money go? Who decides which questions are asked? How do we measure success? All of these are incredibly important questions. If we really want to end breast cancer and save lives, it will take more than just raising and spending more money on research. We need a thoughtful, strategic approach to making certain that money is well spent. We need to know that the end result benefits women and men at risk of and with breast cancer, rather than just supporting institutions, individual scientists and drug companies.

At the National Breast Cancer Coalition (NBCC), we know that advocates trained in the science of breast cancer, women and men who are outside the system of science and research, should lead the way. That might sound strange–lay advocates setting a scientific research agenda? We have proven it works. Educated advocates like the ones at NBCC are the only ones with no agenda other than to end breast cancer. Not get published, or promoted or make a profit. Just save lives.

Try to look up how many institutions around the country are working on breast cancer research. Or how many thousands of scientists are doing that work. You can’t do it. Nor can we easily find out what they are doing in breast cancer. There is little transparency in breast cancer research, beyond piecing together federal funding and what information you can find on private grants and associations. The federal government appropriated more than $800 million last year for breast cancer research. It is estimated that private philanthropy exceeds hundreds of millions of dollars each year. There is no coordination of all of this. Now, I am not suggesting there should be coordination of science. Having all researchers work in lockstep would send us down one road and it may be the wrong one. There would be no room for innovation or really “wild ass” ideas. We need diversity of approaches, replication of findings, innovation and even some incrementalism. But we don’t need so much of it. We do need some segment of all of this working to answer questions that are important to people. And we must have transparency and accountability.

The current world of science rewards publication and grant funding begets more grant funding. So the propensity of researchers is to do what will get published and what will get funded–not necessarily what will save lives because, unfortunately, these are not always the same thing. An individual scientist, or her team, at one institution most often is not collaborating with teams at other institutions, who may have a different way of approaching the same problem. Now, scientists will tell you of course they collaborate. Maybe we define it differently. We define collaboration as an open exchange of ideas; sharing of tools, technology and knowledge; learning from one other and moving forward as partners to answer a big question. We haven’t seen much of that. How much of that research funding we have walked and raced to raise is spent on that type of collaboration?

Do we know what questions are being asked? Do we know if those questions are important? We can know. I recently read a posting from a breast cancer survivor who claimed that a patient cannot understand science and any attempt to read about it was akin to hearing “zebras clumping by all the time.” I immediately thought about the iconic Barbie doll that, when you pulled the string, you heard, “Math class is tough.”Back in 1992, people rightfully pointed out how offensive this was and demeaning to women. We can do math. We can understand scientific articles; we can help decide what is important. It is offensive to suggest otherwise.

One of NBCC’s signature projects is to train advocates at Project LEAD® Institutes and Workshops in the science of breast cancer and on research methodology. They learn basic terminology, foundational concepts, and a way to think critically about science and gain the confidence to ask hard questions. LEAD graduates have gone on to analyze and influence the science itself. Working together with scientists, advocates have influenced how researchers view the significance of their scientific questions, how research designs might impact participants and why results need to be important endpoints and not just extend life for a week or two.

In 1992, NBCC successfully advocated for unprecedented federal funding for breast cancer research: hundreds of millions of dollars for the newly-created U.S. Department of Defense Peer Reviewed Breast Cancer Research Program. As part of this new program, I worked with scientists and program leaders to facilitate trained advocates having a seat at the peer review and programmatic tables. Many Project LEAD® graduates have since sat at those tables to review scientific research proposals and to set the research agenda.

As part of NBCC’s Breast Cancer Deadline 2020®, we launched the Artemis Project®, which is our research work on primary prevention, or stopping women and men from getting breast cancer in the first place, and prevention of metastasis, or preventing women and men from dying of it. We are making progress on these two fronts in large part because they are advocate-led.

Math class may be tough for many men and women. That does not mean it creates a barrier. Science can be accessible to all of us–it’s not just for scientists–and it certainly can sound clearer than zebras clumping. Advocates can understand the science of breast cancer and help determine what research questions should be answered. We’ve made progress in getting more trained advocates to the research table. Now we need to put more advocates–who answer to no one, no institution and no industry but to their desire to end this disease–in charge of setting the breast cancer research agenda.

Follow Fran Visco on Twitter @Deadline2020

 

Cancer Remains Costly Even After The Disease Has Been Treated

HealthDay (1/13, Dotinga) reports that research published in the Journal of the National Cancer Institute suggests that cancer “remains costly even after the disease has been treated.” Investigators found, for instance, that “non-elderly survivors of colon cancer had extra expenses of about $20,000 annually.” The “extra expenses included direct medical costs, as well as lost productivity.” Meanwhile, for breast cancer survivors “under 65, the economic burden totaled about $14,000, and for prostate cancer it was approximately $9,000.”

Long Distances To Treatment Centers May Be An Obstacle For Some Women Seeking Breast Reconstruction Following A Mastectomy

breast_cancer06142HealthDay (1/7, Dallas) reports that research indicates “long distances to treatment centers are a significant obstacle for some women seeking breast reconstruction after a mastectomy.” The study authors wrote, “While greater patient awareness and insurance coverage have contributed to greater breast reconstruction rates in the United States, geographic barriers to access this service remain, particularly to academic centers.” The research was published in Plastic and Reconstructive Surgery (abstract below).

Background: Inadequate access to breast reconstruction was a motivating factor underlying passage of the Women’s Health and Cancer Rights Act. It remains unclear whether all patients interested in breast reconstruction undergo this procedure. The aim of this study was to determine whether geographic disparities are present that limit the rate and method of postmastectomy reconstruction.

Methods: Travel distance in miles between the patient’s residence and the hospital reporting the case was used as a quantitative measure of geographic disparities. The American College of Surgeons National Cancer Database was queried for mastectomy with or without reconstruction performed from 1998 to 2011. Reconstructive procedures were categorized as implant or autologous techniques. Standard statistical tests including linear regression were performed.

Results: Patients who underwent breast reconstruction had to travel farther than those who had mastectomy alone (p < 0.01). A linear correlation was demonstrated between travel distance and reconstruction rates (p < 0.01). The mean distances traveled by patients who underwent reconstruction at community, comprehensive community, or academic programs were 10.3, 19.9, and 26.2 miles, respectively (p < 0.01). Reconstruction rates were significantly greater at academic programs. Patients traveled farther to undergo autologous compared with prosthetic reconstruction.

Conclusions: Although greater patient awareness and insurance coverage have contributed to increased breast reconstruction rates in the United States, the presence of geographic barriers suggests an unmet need. Academic programs have the greatest reconstruction rates, but are located farther from patients’ residences. Increasing the number of plastics surgeons, especially in community centers, would be one method of addressing this inequality.

Kimberly Jewett Consulting, Inc. Hires Veteran Advocate

Beth Fairchild Brings Years of Experience to Patient Advocacy

SAN ANTONIO, TX – December 8, 2015 – Kimberly Jewett Consulting, Inc., a leader in patient advocacy for life sciences markets, is pleased to announce the addition of Virginia “Beth” Fairchild to their team during the 2015 San Antonio Breast Cancer Symposium.

Beth, a seasoned professional, will hit the ground running as she brings several years worth of hands-on client and management expertise, backed by her personal experience as a metastatic breast cancer survivor and passionate patient advocate. Her qualifications include a successful track record in healthcare marketing and sales, and her extensive experience in specifically, metastatic breast cancer with a comprehensive understanding of this sophisticated arena.

As an associate, Beth will be contributing to the growth of the organization by concentrating on enrichment of client satisfaction. In her new role, Beth will act as a conduit to clients when she designs and implements new strategies, and as a liaison to new opportunity development – translating client needs into viable product enhancements and solutions.

When asked about her new role with KJC, Beth replied, “I joined Kimberly Jewett, Inc. because I wanted to be part of a team actively involved in driving patient needs and public understanding of this disease. One hundred and twenty-three women and men will die today from METAstatic Breast Cancer, and one day I will be one of those 123. I look forward to working Kim and moving forward with the pharmaceutical industry to build pharma/patient relationships and to create support and advocacy programming.”

CEO and Founder, Kimberly Jewett adds, “We are excited, honored, and grateful to have Beth join our team, supporting the needs of our clients. Our passion, combined with our purpose and professional skillset, will truly impact the lives of cancer patients and their families, and we are both blessed to have the opportunity to be that voice. While honoring the patients who are fighting, surviving, and thriving every day of their fight, and remembering the ones who lost their lives way too soon. Together, WE CAN make a difference in the lives of cancer patients and their families. People just like US.”

Giving Bad News by Phone May Be the Better Way

Communicating the news that a biopsy result indicates malignancy by telephone may be better than delivering the news in person, a team of researchers from the University of Michigan, in Ann Arbor, suggests. Two outside experts do not altogether agree.

“Telemedicine approaches can potentially relieve much of the anxiety associated with in-person consultations while delivering bad news in a timely, compassionate, and patient-centered manner,” write Naveen Krishnan and colleagues in a viewpoint published in the November issue of JAMA Oncology.

Getting the bad news over the telephone can give patients time to absorb their diagnosis and take greater advantage of their next in-person consultation, Krishnan and colleagues write.

“The initial in-person office visit to communicate malignant biopsy results is arguably less interactive than expected. Patients are not only trying to absorb devastating news but also engage in challenging conversations,” they write. “On the other hand, communication of biopsy results through telecommunication can serve as a buffer to the initial in-person visit and provide time for patients to process the results alone or with family.”

The authors cite examples of oncologic services delivered through telemedicine.

One is the Arizona Telemedicine Program’s Telehealth Rapid Breast Care Process, which lets patients receive their breast cancer diagnosis the same day as their biopsy. The program is conducted under the auspices of the University of Arizona.

Another example is the Ontario Telemedicine Network, located in Canada. With more than 1600 sites and 3000 systems, the OTN is the largest teleoncology service in North America, according to the authors.

“The Ontario Telemedicine Network has overcome a number of barriers, including cost, physician compensation, and resistance to telehealth technology adoption,” they write. “In fact, telehealth technology is now an everyday part of health care delivery in Ontario.”

Krishnan and colleagues claim that for patients, message content and timeliness are the two most important factors in relaying biopsy results. Patients are less interested in nonverbal communication on the part of the physician delivering the bad news, they say.

“In this respect, telemedicine allows physicians to focus on content rather than nonverbal communication that patients may not appreciate at the initial in-person visit,” the authors write.

“With increasing clinical time constraints and the shock of hearing a cancer diagnosis in person, telemedicine encounters can facilitate more meaningful future in-person discussions of complex therapeutic options and their adverse effects,” the authors write.

Read more.

 

FDA “Stepping Up Its Plans” To Regulate Laboratory-Developed Tests

This will have significant implications for patients who have tests performed by companies/laboratories that bring to market to their own tests they have validated and market for clinical testing. FDA, while it has always reserve the right to do so, has largely not regulated laboratory-developed tests.  This appears to be changing with some support by clinical organizations. Further discussions with the FDA, companies, laboratories and clinical diagnostics organizations are going to be required to balance patient safety, quality assurance and access for patients to important tests that are coming to market.

Stat (11/18, Fong) reports in continuing coverage that the Food and Drug Administration “is stepping up its plans to regulate all medical laboratory testing,” as a report released by the agency this week found 20 examples of laboratory-developed tests that may have harmed patients. Dr. Peter Lurie, FDA associate commissioner for public health strategy, said in a blog post, “FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.”

Modern Healthcare (11/18, Dickson) reports that Lurie also said, “These tests may suggest that a patient doesn’t have a disease or condition, when in fact they do.” Dr. Patrick Conway, the chief medical officer of the Center for Medicaid and Medicare Services, the agency that currently has jurisdiction over the lab-developed tests, said, “The CMS does not have a scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly.” Medical societies, including the American Society of Clinical Oncology, support FDA regulation of lab-developed tests. Fortune (11/18) and The Scientist (11/18, Vence) also covered the story.

ASCO Convenes Panel on Costs, Benefits for Patients and Families

cancer-costs1The Philadelphia Inquirer (11/16, Bauers) carries an interview with Dr. Adam Dicker, professor and chair of the Department of Radiation Oncology at Thomas Jefferson University’s Sidney Kimmel Medical College, who is a coauthor of guidelines developed by the American Society of Clinical Oncology “to help physicians, patients, and their families assess efficacy, toxicity, and costs of the various treatment options.” Dicker said, “The good news in oncology is that…there are now a number of new drugs that have clinical benefit.” He explained that ASCO organized a panel to “look at the best-quality data available” in order to calculate cost of treatment and expected benefits. The panel produced “a very useful visual called ‘Evidence Blocks’ that play a pivotal role when having a conversation with a patient and their family.”

ASCO Updates Antiemetic Guidelines in Patients on Chemotherapy

Oncology Nurse Advisor reports that “the American Society of Clinical Oncology (ASCO) has updated their antiemetic guideline regarding the use of palonosetron and netupitant in combination to treat nausea and vomiting in patients receiving chemotherapy.” The update “committee recommends that patients receiving highly emetogenic chemotherapy regimens be offered a combination of a NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone, with netupitant and palonosetron plus dexamethasone (oral combination) also being an option for additional therapy.” Besides that, the “committee…did not recommend deviations from 2011 ASCO guideline at this time.”

The update is published in the Journal of Clinical Oncology.