Category Archives: Government/regulation

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

 

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.

ACS breast cancer screening guidelines unlikely to impact insurance coverage

Kaiser Health News (10/24, Andrews) reported that “the American Cancer Society’s new breast cancer screening guidelines, recommend[ing] that women start screening later and get fewer mammograms…is unlikely to affect insurance coverage anytime soon.” These “guidelines on their own likely won’t change insurer and employer decisions regarding coverage of screening for breast cancer, experts agree.”

USA Today (10/26) editorial criticizes the new American Cancer Society (ACS) mammogram guidelines. USA Today writes that the panel responsible for the guidelines “opted for recommendations that invite devastating consequences for some women.”

In an “Opposing View” in USA Today (10/26), Ruth Etzioni, a biostatistician, and Kevin Oeffinger, a physician, both members of the ACS panel that wrote the guidelines, write, “The recommendation that by age 45 women should undergo regular screening is designed to limit the numbers adversely impacted while benefitting as many as possible.”

The New York Times (10/26, Subscription Publication) also editorializes on the new guidelines, saying they present “another wrinkle for women who are trying to make informed decisions about their health care.” The Times argues that “when there is still such a dizzying array of expert opinion, it would be wiser to require insurers to continue covering all women starting at 40.”

The Washington Post (10/24, Lerner), Barron H. Lerner, a professor in the division of medical ethics at New York University’s Langone Medical Center, wrote that “the ACS is to be applauded,” as “its new guidelines are based on the actual scientific value of early detection, not the organization’s needs and prior beliefs.”

FDA to Establish Patient Advisory Committee on Medical Devices

The Minnesota StarTribune recently reported that an advisory group will provide input on clinical trial designs.

The U.S. Food and Drug Administration announced last Friday the establishment of its first-ever patient advisory committee on medical devices.

The new 11-member group will include nine voting members “knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States.” The committee will also have one nonvoting “consumer representative,” and one nonvoting “industry representative.”

The committee, according to the FDA, is designed to inject a patient perspective into the agency’s deliberations on device development, approval and monitoring. The FDA says the committee will help the government “meet its public health commitment to improve patient health and quality of life.”

Among other things, the committee will offer suggestions about FDA policies and rules and designs for clinical trials and device labels. It also will examine ways to determine patient preferences, how to best report patient experiences with medical devices and how to remedy unmet clinical needs.

The agency has asked for 60 days of public comments to prioritize those points of concern.

One of the primary missions of the committee will be to help figure out when and how patients should have input into the medical device life cycle.

Potential areas of focus could be methods of recruiting patients to and keeping them in research projects. But other potentially significant pieces will be improving ways the public can report their experiences with devices once they are implanted and with telling the public about risks of products that are already on the market.

Consumer advocates and health researchers offered a guarded response to the FDA announcement and not everyone is sold on the idea.

“Often so-called patient groups are sponsored heavily by the medical device industry,” said Dr. Michael Carome, health research director at the consumer group Public Citizen. “Patients can make the agency aware of unmet medical needs. But when [FDA] decides whether or not to approve a device, the decision should be made based on scientific research and not patient preference.”

There is a “big problem” with the lack of influence of patients and consumers in the device approval and monitoring processes, added Diana Zuckerman, president of the National Center for Health Research, a think tank focused on the safety and effectiveness of medical devices.

Patients and consumers have traditionally been treated as “an annoyance” by FDA committees, Zuckerman said. Still, she is not sold on the idea that “segregating them into their own panel will be helpful.”

Besides industry sponsorship of supposed patient representatives, Zuckerman said, “We seem to get the same three patient representatives on every panel. We are not getting true independent voices of people who have experience with drugs or devices.”