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Oncology Times:
doi: 10.1097/01.COT.0000452088.94614.2b
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Advocacy Organization Launches Campaign to Boost Innovation in Cancer Therapies

Eastman, Peggy

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WASHINGTON—The nonprofit National Patient Advocate Foundation (NPAF) has released a sweeping white paper calling for a national effort to jumpstart novel approaches to developing cancer therapies that work. The document, “Securing the Future of Innovation in Cancer Treatment,” will spearhead a new NPAF campaign, called Project Innovation, which aims to involve patients, family members, and local citizens in speaking out about the importance of accelerating the development of novel treatments in oncology.

The new white paper, written by NPAF Executive Vice President Lou LaMarca and Legislative Affairs Director Ian Hunter, cites data from the American Cancer Society showing that in 2014 the United States will spend about $201.5 billion in health care costs to fight cancer and provide treatment to the 1.6 million Americans who will be diagnosed with cancer this year.

Undergirding the white paper, according to NPAF, are concerns about a nearly 20 percent drop in U.S. government-funded basic research since 2010, and a steady decline in U.S. venture capital investment in biotechnology since 2007. These trends are especially worrisome considering that it costs upwards of $1 billion to develop a novel cancer drug.

“Developing a cure for cancer is a daunting task that can be achieved only through substantive and cooperative investment from all health care stakeholders, including the biopharmaceutical industry, academia, health care payers, providers, nonprofit patient organizations, and the public sector to the process of innovation,” the paper states.

The project will draw on leaders from national cancer advocacy organizations, cancer care providers, biomedical researchers and the business community “to put cancer innovation on the policy agenda,” according to NPAF.

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Re-energize

In a telephone interview from the American Society of Clinical Oncology Annual Meeting, where the white paper was released on May 30, NPAF Founder and Chairman Nancy Davenport-Ennis, a two-time breast cancer survivor, said, “We can do better as a nation.” The hope, she said, is to re-energize the public to care about innovation in cancer treatment in a way similar to what happened in the mid-1950s when mothers took to the streets to demand a cure for polio, and in the 1980s when patients and advocacy organizations mobilized to fight the scourge of HIV/AIDS.

NPAF believes, she added, that the document's recommendations are “a wakeup call for all Americans,” and that the country needs to get its brightest minds working on solutions. Davenport-Ennis has served on many national committees, including the NCI Director's Consumer Liaison Group. She held a voting seat on the Medicare Coverage Advisory Committee of the Centers for Medicare and Medicaid Services (CMS), and she serves on the board of directors of FOCR.

NANCY DAVENPORT-ENNIS
NANCY DAVENPORT-ENNIS
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The NPAF white paper was written following a series of meetings by a network of biomedical researchers, medical innovators, patient advocates, and clinicians called the Cancer Innovation Coalition, which also includes the ACCC, Bristol-Myers Squibb, the CSC, Celgene Corporation, the CCA, the Council for Affordable Health Care, FOCR, Genentech, GlaxoSmithKline, Eli Lilly, Novartis, ONS, Pfizer Inc., and US Oncology Network.

The coalition provided guidance on issues explored in the document. The report makes the point that about 95 percent of investigational compounds under study in humans fail to meet standards for safety and efficacy, stating, “Development is an uncertain process, with an estimated 19 out of 20 drugs in development never making it to market.”

Because development of innovative therapies is uncertain, research and development require consistent financial support, which pays off, the report states. And while there have been “substantial gains made within the field of cancer innovation”—for example, treatment of lung cancer and chronic myeloid leukemia (CML)—“much progress remains to be done.”

The white paper shows that between 1988 and 2000, life expectancy for cancer patients increased overall by about four years, which translates to some 23 million additional years of life and about $1.9 trillion in value added to the U.S. economy. Since some recent cancer therapies are better tolerated by patients than traditional chemotherapy is, “the quality-adjusted life benefit could be even greater,” according to data cited in the report.

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Obstacles & Challenges

In its analysis of clinical trials, which the new report calls the “crux of cancer innovation,” the white paper cites these obstacles and challenges to U.S. innovation in cancer treatment:

  • The trend of moving clinical trials overseas—which not only stifles U.S. innovation, but also raises questions about the applicability of trial results to U.S. patients. In the interview, Davenport-Ennis noted that the United Kingdom has increased its clinical trial accrual rate from three to four percent to 12 percent through concentrated effort. She said it would be ideal if a newly diagnosed U.S. cancer patient could go to one source that would tell him or her which trials might be suitable before having any treatment, since prior chemotherapy might make that patient ineligible for a clinical trial.
  • Lack of a supportive clinical research infrastructure, especially in the form of administrative and financial support for busy practitioners, whose reimbursement for clinical trial participants can in some cases be less than they would receive from patients in clinical practice. “You can be a doctor and lose money on every patient you put on a trial,” Davenport-Ennis noted.
  • Participant enrollment exclusions, especially the exclusion of older patients (who are more likely to develop cancer because of age) from clinical research because of comorbid conditions.

Innovative breakthroughs in cancer treatment bring not only “tremendous personal value to patients and families,” but also “substantial economic health care system,” according to the report. The following are specified as overarching solutions to boost innovation in cancer treatment:

  • Expanding on the science of innovation by streamlining logistical obstacles. The report recommends reducing logistical, bureaucratic, institutional, and regulatory obstacles to innovation “to the greatest extent possible.” Specifically, it calls for a more streamlined infrastructure: “Documentation and auditing mandates, divergent local institutional review board (IRB) requirements for consent forms and protocols, duplicative and conflicting standards, increasing regulatory requirements and delays in review decisions are often unnecessarily burdensome without providing an additional measure of safety for study subjects or a commensurate gain in the quality of clinical research.”

The document states that reducing such hurdles will require “a nationwide strategic plan among all stakeholders” in order to establish “uniform, or at least coherent, requirements among research institutions and across government agencies.” In two reports in recent years, the Institute of Medicine also called for streamlining the clinical trials process to boost the development of innovative cancer therapies.

  • Improving the value of innovation by bolstering funding opportunities. Like the American Association for Cancer Research and the American Society of Clinical Oncology, NPAF strongly recommends boosting funds for innovative cancer research: “Investment in medical innovation will improve health care outcomes for patients and lower long-term health costs, relieving financial pressures on federal programs such as Medicare and Medicaid, and lowering costs borne by employers for the health care of their employees.”

Specifically, the NPAF white paper calls for increased Congressional appropriations for cancer research, and a renewed U.S. commitment to the value of such research: “Public and private sector stakeholders need to be united in their dedication to fund the basic research that provides the foundation for the discovery of innovative treatments and therapies,” the report states.

The role of the federal National Institutes of Health in funding research in the life sciences, and the role of the Food and Drug Administration in finding creative ways to promote medical innovation are critically important. “However, further government investment is needed to increase the transparency, efficiency, and effectiveness of these agencies while mitigating regulatory impediments,” the document notes.

  • Enhancing delivery of innovation through improved communication and coordination between providers and patients. The white paper recommends that patient access to clinical trials be expanded by the federal government, and that there should be much better communication to cancer patients of available clinical trials, which will require better coordination among oncology researchers, treating oncologists, and patients. It is up to oncologists to become familiar with relevant clinical trials and to “share that information with their oncology patients for whom such trials are appropriate,” states the report. There should also be regulatory policies ensuring that payers cover clinical trial costs for patients, as required by statute and Executive Order.

In addition, the white paper recommends more research collaboration, especially among private and public entities, and urges the federal government to develop incentives to enhance collaborative efforts among pharmaceutical companies and other researchers.

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Supporting Organizations

Initial organizations that have signed on in support of NPAF's Project Innovation include:

  • The Oncology Nursing Society;
  • The Association of Community Cancer Centers (ACCC);
  • Friends of Cancer Research (FOCR);
  • The Colon Cancer Alliance (CCA); and
  • The Cancer Support Community (CSC).
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Executive Board Members

Executive board members of the NPAF are:

  • Board President F. Marc Stewart, MD, Professor of Medicine at Fred Hutchinson Cancer Research Center;
  • Immediate Past Board President Dennis A. Gastineau, MD, Chair of the Division of Hematology and Director of the Human Cell Therapy Laboratory in the Divisions of Transfusion Medicine & Hematology at the Mayo Clinic;
  • Board Executive Vice President Al Benson III, MD, Professor of Medicine and Associate Director for Clinical Investigation at Robert H. Lurie Comprehensive Cancer Center of Northwestern University;
  • Christian G. Downs, JD, MHA, Executive Director of the Association of Community Cancer Centers;
  • Lovell Jones, PhD, Professor Emeritus and University of Texas Distinguished Teaching Professor at the University of Texas MD Anderson Cancer Center and Co-Founder of the Intercultural Cancer Council; and
  • Lori Williams, PhD, MSN, RN, Assistant Professor in the Department of Symptom Research at MD Anderson.
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Selected Other NPAF White Papers

The NPAF has also published white papers on medical debt (2014), medical bankruptcy and the impact on patients (2012), and economic constraints on providers and the impact on access to care (2012).

Wolters Kluwer Health | Lippincott Williams & Wilkins

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