July 2003 NEWSLETTER

July 30, 2003

Friends of Cancer Research is a non-profit organization dedicated to accelerating the nation’s progress toward prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues.

CONGRESSIONAL UPDATE

FY 2004 Labor-HHS-Education Appropriations
It seems likely that the FY 2004 Labor-HHS-Education appropriations bill will not reach the Senate floor until September. The Senate recently completed action on the Department of Defense appropriations and currently is planning to focus on the Homeland Security and Energy bills in the upcoming weeks. The proposal put forth by the House and the Administration in the FY 2004 Labor-HHS-Education appropriations bill allots $27.7 billion to the National Institutes of Health (NIH), a 2.5 percent increase over FY 2003. The parallel Senate bill would increase NIH funding by 3.7 percent to $27.9 billion. Senator Diane Feinstein (D-CA) is working on an amendment to add an additional $1.3 billion to the Senate bill for NIH - a total of $29.3 billion, or an increase of 8.5 percent. Her staff is considering an offset.

NATIONAL RESEARCH COUNCIL and INSTITUTE OF MEDICINE REPORT

Report Recommends Reconsideration of NCI's Special Status Under the National Cancer Act
In response to a congressional request, on July 29, 2003, the National Research Council (NRC) and Institute of Medicine's (IOM) Committee on the Organizational Structure of the National Institutes of Health (Committee) released a report entitled "Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges." The goal of the report was to issue recommendations to optimize NIH's organizational structure in the context of 21st century biomedical research. Among the Committee's 14 recommendations is a recommendation to reconsider NCI's special status under the National Cancer Act.

Specifically, the report states:

"Recommendation 12: Reconsider the Status of the National Cancer Institute Congress should reassess the provisions of the National Cancer Act of 1971, particularly as they affect the authority of the NIH director to hire senior management and plan and coordinate the NIH budget and its programs in their entirety.

...The committee believes that the special status granted NCI by the National Cancer Act should be re-examined. The National Cancer Act of 1971, in addition to making the NCI director a Presidential appointee, created the President's Cancer Panel, composed of two scientists and one management specialist who provide progress reports to the president on the status of NCI's research. The act also replaced the National Cancer Advisory Council with an 18-member National Cancer Advisory Board composed of scientists and laypersons offering guidance and advice to NCI on all major initiatives. In addition, the act allows the NCI director to submit the institute's budget directly to the President, bypassing the NIH director in the process.

Because the President appoints the NCI director and the NCI budget bypasses the NIH director, it is possible that an unnecessary rift is created between the goals, missions, and leadership of NIH and those of NCI. NCI is by far and has been for some time the largest NIH institute (approximately 17% of the total NIH budget). It is not in the interests either of NIH's overall research and training programs, or of NCI, for the NIH director to have such limited authority. In addition, as the biological cellular basis of cancer becomes more widely understood, the basic science underlying cancer research has direct implications for the etiology and progression of numerous other diseases, for example autoimmune, infectious, and even cardiovascular diseases. Thus, for scientific and administrative reasons, NCI's special status should be reconsidered."

Friends will keep you posted on the developments of this recommendation. We welcome your comments about the joint NRC and IOM report. Please click here to send us your thoughts.

The full report can be accessed or ordered from here. To read the press release on the report click here.

FDA DEVELOPMENTS

FDA to Reduce Drug Approval Times
At the annual meeting of the American Association of Cancer Research (AACR) on July 12, 2003, FDA Commissioner Mark B. McClellan addressed the goal of reducing drug approval times and costs, expanding on his remarks from the BIO 2003 annual meeting on June 23, 2003. FDA plans to establish internal-performance measures, a peer-review program and a quality-control system for reviewing products in order to streamline the review process and cut the cost of developing new medications. Commissioner McClellan is proposing to increase transparency in order to avoid multiple review cycles, which are both costly and time consuming. The FDA will provide feedback to companies designing experimental drugs earlier in the process. The agency also will create new guidelines for products targeting obesity, diabetes and cancer (specifically lung, prostate, breast and colon cancers) in order to clarify approval requirements.

FRIENDS ACCOMPLISHMENTS

"Overcoming Barriers to Early Phase Clinical Trials" Public-Private Partnership
On July 9, 2003, in the Dirksen Senate building on Capitol Hill, the Secretary of Health and Human Services, Tommy Thompson, announced grant awards for six cancer centers chosen by the "Overcoming Barriers to Early Phase Clinical Trials" public-private partnership. The institutions selected for grants were Massachusetts General Hospital, University of Colorado Health Sciences Center, Washington University in St. Louis, University of Pittsburgh Cancer Institute, University of California Davis Cancer Center, and Ohio State Comprehensive Cancer Center.

Secretary Thompson summed up the magnitude of the public-private partnership: "These volunteers are critical to our research. The better we understand these diseases, the better we will be able to prevent them and the better we will be able to treat other patients affected by them. And because different people respond to treatments in different ways, we need more clinical volunteers - of all shapes and sizes and ages - in order to enhance and in order to improve our medical knowledge...These centers will implement and design new approaches to recruit more elderly and minority volunteers. And these grants open up a new front in our fight against cancer."

From left to right: HHS Secretary Tommy Thompson, Senator Edward M. Kennedy (D-MA)

The American Association of Cancer Institutes (AACI) proposed the partnership, and Friends of Cancer Research (Friends) developed this groundbreaking collaborative effort between the National Cancer Institute (NCI), the Foundation for the National Institutes of Health (FNIH), and five pharmaceutical companies: Aventis, Bristol-Myers Squibb, Eli Lilly & Company, GlaxoSmithKline, and Novartis. The partnership provides a total of $5.7 million to the six cancer centers in order to improve geriatric and minority patient access to early phase clinical trials. Click here for more information on the public-private partnership.

Dr. Andrew von Eschenbach, Director of the National Cancer Institute

Senators Edward M. Kennedy (D-MA), Wayne Allard (R-CO), Ben Nighthorse Campbell (R-CO), Rick Santorum (R-PA), Arlen Specter (R-PA) and Representative William Lacy Clay (D-MO 1st) participated in the press conference. In addition, Dr. Andrew von Eschenbach, Director of the NCI and Amy McGuire, Executive Director of FNIH offered remarks. "Friends of Cancer Research and the National Institutes of Health Foundation have created a partnership to help us learn more about the barriers and obstacles [to clinical trials] and eliminate them so that we make it possible for more people to be able to benefit from the tremendous progress that has occurred by virtue of our investment in biomedical research," stated Dr. Andrew von Eschenbach.

Amy McGuire, Executive Director of the Foundation for the National Institutes of Health

Ms. Kimberly Lawler-Krain, Ms. Juanita E. Lyle, Mr. Stephan L. Walker, and Ms. Charlene Gaddy Wallace represented the strong support for the public-private partnership from a diverse cancer patient community. Their stories, which highlight obstacles to clinical trial participation, inspired Friends and FNIH to form the partnership. Ms. Lawler-Krain and Ms. Wallace spoke at the event. "It is so important for my community that I have the opportunity to share my story so others can learn from my experience and seek treatment in clinical trials," said Ms. Wallace. She concluded by advising minority patients to "play an active role in your health care. Ask questions, stand up, look it in the face and be proactive."

From left to right: Ms. Kimberly Lawler-Krain, Ms. Charlene Gaddy Wallace, Dr. Andrew von Eschenbach, Mr. Stephan L. Walker, Ms. Juanita E. Lyle

Federal Technology Transfer Policy Testimony
Ellen V. Sigal, Chairperson of Friends, testified on Federal Technology Transfer Policy at a House, Energy and Commerce Committee Subcommittee on Health on July 10, 2003. Dr. Sigal focused on how patients benefit when discoveries of NIH scientists or those supported by the NIH, are transferred to the private sector for the complex, risky, and expensive process of commercial product development. In summary, Dr. Sigal testified that the current system of knowledge management, information dissemination and technology transfer at the NIH works remarkably well and cautioned the subcommittee against undertaking actions that would fundamentally jeopardize that record of success. She underscored the necessity of positive partnerships and collaborations between the government and the private sector and cautioned that patients will suffer if policy decisions impede the dissemination of knowledge and appropriate transfer of technology.

Ellen V. Sigal, PhD, Appointed to the Board of the Foundation for the NIH
On July 9, 2003, at the "Overcoming Barriers to Early Phase Clinical Trials" public-private press conference, Amy McGuire, Executive Director of the Foundation for NIH (FNIH) announced that Ellen V. Sigal, Chairperson of Friends agreed to serve on the FNIH Board of Directors. FNIH builds and fosters collaborative relationships with philanthropy, industry, and academia to support the mission of the NIH--improving health through scientific discovery. Friends worked closely with FNIH and the NCI to make the public-private partnership a reality.