Friends of Cancer Research

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Friends of Cancer Research

Washington, DC, United States
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News Article | May 23, 2017
Site: www.npr.org

This story was updated on May 24 to clarify include new information on proposed cuts to Medicaid. The proposed budget unveiled Tuesday by the Trump administration doubles down on major cuts to biomedical research; programs to fight infectious disease outbreaks; health care for the poor, elderly and disabled; and prevention of HIV/AIDS. It restates the goals of the "skinny budget" the administration released in March, which was widely condemned by scientists and public health advocates. Mick Mulvaney, director of the Office of Management and Budget, said Monday that the goal is to cut back on public assistance and instead put people back to work. "We are going to measure compassion and success by the number of people we help get off of those programs and get back in charge of their own lives." No one thinks the president's budget will pass as proposed, since Congress has budget and spending authority. But it does provide a baseline from which negotiations may begin. "The president is right to take a close look at spending," says Sen. Chuck Grassley, R-Iowa. But "Congress has the power of the purse strings. I've never seen a president's budget proposal not revised substantially." Here's a rundown of the budget's medical research and health care proposals. Medicaid: The budget proposes cutting Medicaid and CHIP, the Children's Health Insurance Program, by $616 billion over 10 years, with almost half the savings occurring in the last two years. But it appears that the $616 billion number doesn't include the roughly $800 billion that would be cut from Medicaid funding by the House-passed version of the American Health Care Act. Mulvaney told the House Budget Committee Wednesday that there is some overlap in the two numbers, but the exact amount of the overlap remains a mystery. The joint federal-state programs provide health care and support services for 75 million low-income, elderly and disabled people, about half of whom are children. In 2015, federal and state spending on Medicaid was about $545 billion. The budget mirrors the changes in Medicaid included in the health care overhaul bill passed by the House earlier this month. Rather than the federal government matching state spending based on beneficiaries' health care needs, it would give states a fixed amount of money per enrollee or, alternatively, offer states a fixed block grant. That would cut the program's growth over time and reduce services because health care costs grow faster than the broad economy. Medicaid benefits for the elderly and disabled: Medicaid pays for services — including personal care, shopping or cooking for the elderly, and occupational therapy and work support for the disabled — that allow people to continue to live on their own. Under the law, those services are considered optional. But Medicaid is required to pay for nursing home and institutional care. "We'll see a return to more people with disabilities and more older adults not having access to services that allow them to remain at home," says Barbara Beckert, director of the Milwaukee office of Disability Rights Wisconsin. "Instead, we may see people forced into institutions, forced into nursing homes." Refugee benefits: The proposed budget makes the argument that the U.S. should reduce the number of refugees it brings into this country because those fleeing persecution in their home countries often end up using public assistance, including 50 percent who were on Medicaid in 2015. "The larger the number the United States admits for domestic resettlement, the fewer people the United States is able to help overall," the budget document says. National Institutes of Health: The NIH, which funds research into medical treatments and basic science, would see cuts of almost $6 billion, to about $26 billion. That would include a $575 million cut to the National Heart, Lung and Blood Institute and $838 million cut to the National Institute of Allergy and Infectious Diseases, which is involved in a wide range of diseases including AIDS and Zika. The National Institute of Diabetes and Digestive and Kidney Diseases would be cut by $355 million. The proposed cuts drew immediate and harsh criticism. The cuts would "cripple our nation's scientific efforts, undermining our economic growth, public health and national security," Mary Sue Coleman, president of the Association of American Universities, said in a statement. The cuts could "hobble our ability to provide tomorrow's cures and technologies." Centers for Disease Control and Prevention: The administration proposes trimming the CDC, which helps states and other countries fight infectious disease outbreaks, by $1.3 billion — 17 percent. That could include a $186 million cut in programs at the CDC's center on HIV/AIDS, hepatitis and other sexually transmitted diseases. The CDC's chronic disease prevention programs, such as those for diabetes, heart disease, stroke and obesity, would be cut by $222 million. The proposed cut to CDC "would be perilous for the health of the American people," says John Auerbach, president and CEO of the Trust for America's Health. "From Ebola to Zika to opioid misuse to diabetes to heart disease, the CDC is on the front lines keeping Americans healthy." Food and Drug Administration: A 31 percent proposed cut, from $2.7 billion to $1.89 billion, would be offset by $1.3 billion in proposed increased fees to be paid by drugmakers and device-makers. The budget shows a basic misunderstanding of how these agencies function, says Ryan Hohman, vice president of public affairs at the group Friends of Cancer Research. "To further suggest that private sector industry make up for such a significant cut to the FDA as proposed by the president shows a lack of knowledge for how user fees can be used and the scope of the FDA's pivotal role in assuring the safety of the daily lives of Americans." The budget doesn't explicitly address high drug costs, though Trump has frequently inveighed against drug prices, telling Congress in February that it should "work to bring down the artificially high price of drugs and bring them down immediately." Planned Parenthood: The family-planning organization has been the target of efforts to cut funding for years because it provides about one-third of the nation's abortions. This budget would be the first to bar a specific provider, according to Planned Parenthood. And it would bar the organization not only from Medicaid funding but also from any other Health and Human Services program, including the Title X family planning program, maternal and child health, STD testing and treatment, and Zika prevention. "From Day 1, President Trump has worked to keep his pro-life promises, including stopping taxpayers from being forced to fund abortion and abortion businesses," says Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony List. "Taxpayers should not have to prop up Planned Parenthood's failing, abortion-centered business model." Planned Parenthood officials said Tuesday that many of their clients don't have other places to get health care. "We've already seen the results of these sorts of policies in Texas, so we know what would happen," says Kevin Griffis, vice president at Planned Parenthood Federation of America. "The heartbreaking truth is that if this budget were enacted, the results would be catastrophic for countless women and their families — cancers and diseases going undetected, higher maternal mortality and more unintended pregnancies."


Washington, D.C., June 27, 2017 (GLOBE NEWSWIRE) -- Amid proposed federal government budget cuts, more than 250 cancer researchers, medical professionals, policymakers, patients, caregivers, survivors, and advocates will convene in Washington, D.C. today for Cancer Moonshot: One Year Later. The Summit is jointly hosted by seven of the leading cancer organizations: Cancer Support Community (CSC), American Cancer Society Cancer Action Network (ACS CAN), CancerCare, Friends of Cancer Research, LIVESTRONG Foundation, National Coalition for Cancer Survivorship (NCCS), and the National Patient Advocate Foundation (NPAF). Following the launch of the Biden Cancer Initiative yesterday, the summit will celebrate the Biden Cancer Moonshot Initiative’s first year of progress, identify gaps, define opportunities for ongoing and new collaborative action, and continue to build momentum around the national effort to end cancer as we know it. “This second gathering of such a large and varied group of stakeholders is proof of the far-reaching impact of Vice President Biden’s call to action,” remarked Kim Thiboldeaux, CEO of CSC. “In the face of proposed government budget cuts, the non-profit and corporate sectors are stepping up to carry the Moonshot forward, demonstrating a collective unwavering commitment to reaching its goal. Cancer Moonshot: One Year Later is an opportunity for the cancer care community to come together, announce new initiatives, examine previous ones and, stay the course towards accelerating the rate of cancer discoveries.” The Cancer Moonshot aims to dramatically accelerate progress toward cures—to make a decade's worth of advances in cancer prevention, diagnosis, treatment, and care in just five years. In his final State of the Union address in January 2016, former President Barack Obama tasked former Vice President Joe Biden with leading the Cancer Moonshot. At the June 2016 Cancer Moonshot Summit, Vice President Biden called on stakeholders to publicly pledge commitments to ensure the Cancer Moonshot, an unprecedented collaboration between researchers, oncologists, care providers, philanthropists, data and technology experts, advocates, patients, and survivors, would reach its goal by 2020. “The Cancer Moonshot Initiative, led by Vice President Biden, really galvanized people to work together. CSC is helping maintain our collective sense of optimism by convening various groups to identify opportunities for progress. We urge Congress and the current administration to build on this momentum and continue to make fighting cancer a top national priority,” said Chris Hansen, President of the ACS CAN. "Despite the current turmoil in health care policy and funding, it's critical to maintain the Cancer Moonshot momentum behind collaboration, discovery, and keeping patients at the center of all our efforts," said Patricia J. Goldsmith, CEO of CancerCare. “In its first year, the Cancer Moonshot has been a great success by priming the research community to discover revolutionary new treatments for patients,” said Ellen Sigal, Chairperson and Founder of Friends of Cancer Research. “Despite the incredible progress, it is imperative that we remain vigilant in ensuring our scientists and researchers continue to receive the crucial funding they need to make new therapies a reality for patients.” “The Cancer Moonshot Initiative sparked a renewed national commitment to fight cancer. While so much work is left to be done, this event marks the progress made since the historic announcement a year ago. LIVESTRONG remains dedicated to advancing its moonshot pledge and working alongside others in the cancer community to improve services for cancer survivors,” said Greg D. Lee, President of LIVESTRONG. "Too many cancer patients today face the dual tragedies of fearing the science won't save them, and they wouldn't be able to afford it even if it could. We need initiatives like the Cancer Moonshot to keep us focused, as a nation, on bringing innovation to all those who need it,” said Alan Balch, CEO of NPAF. Updates from major initiatives announced by the Cancer Moonshot Blue-Ribbon Task Force will be presented. The summit’s goal is to help maintain, foster, and support the efforts, pledges, and goals made in 2016 moving forward. Cancer Moonshot: One Year Later is taking place on Tuesday, June 27, 2017, from 10:00 a.m. - 4:30 p.m. at the JW Marriott, Washington, D.C. For more information about Cancer Moonshot: One Year Later, please visit: http://bit.ly/2sKFO9s Watch the Summit live starting at 10 a.m ET: www.facebook.com/CancerSupportCommunity As the largest professionally led nonprofit network of cancer support worldwide, the Cancer Support Community (CSC), including its Gilda’s Club affiliates, is dedicated to ensuring that all people impacted by cancer are empowered by knowledge, strengthened by action, and sustained by community. CSC achieves its mission through three areas: direct service delivery, research, and advocacy. The organization includes an international network of Affiliates that offer the highest quality social and emotional support for people impacted by cancer, as well as a community of support available online and over the phone. The Research and Training Institute conducts cutting-edge psychosocial, behavioral, and survivorship research. CSC furthers its focus on patient advocacy through its Cancer Policy Institute, informing public policy in Washington, D.C. and across the nation. For more information, please call the toll-free Cancer Support Helpline at 888-793-9355, or visit www.CancerSupportCommunity.org. So that no one faces cancer alone® A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/90051f2e-2fc0-487f-a9f8-a1b1abc702d8 A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2da41aff-59ac-4721-8c3f-0d56958bf8b8


Fridlyand J.,Genentech | Simon R.M.,U.S. National Cancer Institute | Walrath J.C.,Friends of Cancer Research | Roach N.,Fight Colorectal Cancer | And 6 more authors.
Nature Reviews Drug Discovery | Year: 2013

As diagnostic tests become increasingly important for optimizing the use of drugs to treat cancers, the co-development of a targeted therapy and its companion diagnostic test is becoming more prevalent and necessary. In July 2011, the US Food and Drug Administration released a draft guidance that gave the agency's formal definition of companion diagnostics and introduced a drug-diagnostic co-development process for gaining regulatory approval. Here, we identify areas of drug-diagnostic co-development that were either not covered by the guidance or that would benefit from increased granularity, including how to determine when clinical studies should be limited to biomarker-positive patients, defining the diagnostically selected patient population in which to use a companion diagnostic, and defining and clinically validating a biomarker signature for assays that use more than one biomarker. We propose potential approaches that sponsors could use to deal with these challenges and provide strategies to help guide the future co-development of drugs and diagnostics. © 2013 Macmillan Publishers Limited. All rights reserved.


Horning S.J.,Genentech | Haber D.A.,Massachusetts General Hospital | Haber D.A.,Howard Hughes Medical Institute | Selig W.K.D.,Melanoma Research Alliance | And 6 more authors.
Clinical Cancer Research | Year: 2013

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a "Breakthrough Therapy", the U.S. Food and Drug Administration (FDA) and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development. The breakthrough legislation requires that an FDA guidance be drafted that details specific requirements of the bill to aid FDA in implementing requirements of the Act. In this article, we have proposed criteria to define a product as a Breakthrough Therapy, and discussed critical components of the development process that would require flexibility in order to enable expedited development of a Breakthrough Therapy. © 2013 American Association for Cancer Research.


Cleeland C.S.,University of Houston | Allen J.D.,Friends of Cancer Research | Roberts S.A.,Friends of Cancer Research | Brell J.M.,U.S. National Cancer Institute | And 6 more authors.
Nature Reviews Clinical Oncology | Year: 2012

Our understanding of the biology of cancer and the application of this knowledge to cancer treatment has greatly outpaced what we know of the biology underlying the symptoms and toxic effects that therapies produce. These adverse effects of therapy cause substantial discomfort and distress to patients and their families, limit treatment tolerability and can persist indefinitely in post-treatment survivorship. Despite these concerns, little research effort is targeted at documenting the nature of these effects. Similarly, limited efforts are being made in the drug-development arena to identify or develop treatments that might prevent or reduce toxicities. A panel of clinicians and researchers as well as representatives from advocacy groups, federal agencies and the pharmaceutical industry was convened to identify gaps in cancer treatment toxicity research and to provide direction for future action. With an emphasis on coordinating multidisciplinary efforts, this panel has presented a strategy to increase funding for the field and develop a coherent research agenda. © 2012 Macmillan Publishers Limited. All rights reserved.


Rubin E.H.,Merck And Co. | Allen J.D.,Friends of Cancer Research | Nowak J.A.,NorthShore University Health System Pathology and Laboratory Medicine | Bates S.E.,U.S. National Cancer Institute
Clinical Cancer Research | Year: 2014

Advances in understanding the biology of cancer, as well as advances in diagnostic technologies, such as the advent of affordable high-resolution DNA sequencing, have had a major impact on the approach to identification of specific alterations in a given patient's cancer that could be used as a basis for treatment selection, and hence the development of companion diagnostics. Although there are now several examples of successful development of companion diagnostics that allow identification of patients who will achieve the greatest benefit from a new therapeutic, the path to coapproval of a diagnostic test along with a new therapeutic is complex and often inefficient. This review and the accompanying articles examine the current state of companion diagnostic development in the United States and Europe from academic, industry, regulatory, and economic perspectives.©2014 American Association for Cancer Research.


Hayes D.F.,University of Michigan | Allen J.,Friends of Cancer Research | Compton C.,Critical Path Institute | Gustavsen G.,Health Advances | And 9 more authors.
Science Translational Medicine | Year: 2013

Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insuf cient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders. Copyright © 2013, American Association for the Advancement of Science.


Shah R.R.,Rashmi Shah Consultancy Ltd | Roberts S.A.,Friends of Cancer Research | Shah D.R.,Rashmi Shah Consultancy Ltd
British Journal of Clinical Pharmacology | Year: 2013

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. © 2013 The Authors.


Roberts S.A.,Friends of Cancer Research | Allen J.D.,Friends of Cancer Research | Sigal E.V.,Friends of Cancer Research
Health Affairs | Year: 2011

The US Food and Drug Administration is often criticized as inefficient compared to its European counterpart, the European Medicines Agency. This criticism is especially common in the field of oncology, where severely ill patients have few therapeutic options. We conducted a direct drug-to-drug comparison of the two regulatory agencies' approvals of new oncology drugs. We found that contrary to public assertions, the median time for approval for new cancer medicines in the United States was just six months-and that these new anticancer medicines are typically available in the United States before they are in Europe. Our findings reinforce the need for strong financial and public support of the Food and Drug Administration, so that such medicines can continue to be made available speedily to patients in need. © 2011 Project HOPE-The People-to-People Health Foundation, Inc.


Shea M.B.,Friends of Cancer Research | Roberts S.A.,Friends of Cancer Research | Walrath J.C.,Friends of Cancer Research | Allen J.D.,Friends of Cancer Research | Sigal E.V.,Friends of Cancer Research
Clinical Cancer Research | Year: 2013

This study explores the historic use of different endpoints to support regular and accelerated approval of cancer drugs between 2002 and 2012. In the past 10 years, two thirds of oncology regular approvals were based on endpoints other than overall survival. More than three quarters of accelerated approvals were based on response rates. The accelerated approval program has been heavily used over this time period, with one third of all approved oncology indications receiving accelerated approval. At times, critics have characterized the agency as rigid and unpredictable. This research describes the degree of regulatory flexibility that U.S. Food and Drug Administration and drug sponsors have used over the past decade in the development of new treatments for cancer. © 2013 American Association for Cancer Research.

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