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APRIL 2005
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FOCR and AACI Host Day on The Hill
3299 K Street, NW,
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O n April 5th, Friends of Cancer Research joined with the Association of American Cancer Institutes to host a day of activities on Capitol Hill that focused on the importance of cancer centers to advancing research, patient care, and economic infrastructure. Featuring directors and senior representatives from 24 cancer centers representing 15 states and the District, the events included congressional office meetings, a lunch briefing for health staffers, and an evening reception for members and special guests. The Senate Cancer Coalition and the House Cancer Caucus co-sponsored the briefing and the reception.
Cancer center directors touched
on numerous themes throughout day including the critical role of federal
funding for cancer research, the importance of the National Cancer Institute
and the special authorities it was granted through the 1971 National
Lunch Briefing In addition to the nearly 40 representatives from cancer centers, the luncheon briefing was attended by roughly 50 congressional staffers from both House and Senate offices. The panel discussion was moderated by Dr. Karen Antman, MD, the Deputy Director of the NCI’s Translational and Clinical Sciences. The panelists included Dr. Edward Benz, Jr. of the Dana-Farber Cancer Institute in Massachusetts, Dr. Judith Gasson of the UCLA Jonsson Comprehensive Cancer Center in California, Jim Miller, a patient representative from the UCSF Cancer Center in California, Dr. Robert Young of the Fox Chase Cancer Center in Pennsylvania, and Dr Harold Moses of the Vanderbilt-Ingram Cancer Center in Tennessee.
Panelists pictured above from left to right: Dr. Harold Moses, Dr. Karen Antman, Jim Miller, Dr. Judith Gasson, Dr. Robert Young, Dr. Edward Benz. A concern common to all the panelists was that the enormous scientific momentum that has been building in the fields of proteomics, genomics, and nanotechnology may falter or be delayed if federal research funding waivers. Advancements in these fields hold the greatest promise for creating better tools for the prevention and early detection of cancer, which are absolutely critical to achieving the Administration’s goal of eliminating the suffering and death due to cancer by 2015. Hill Visits Following the luncheon, the cancer center representatives participated in dozens of office meetings throughout the afternoon on both the House and Senate side. In addition to explaining the role federal dollars play in the cutting edge science and patient care being conducted at their centers, many of the cancer center representatives touched on other issues such as drug safety and the important role of the special authorities granted to the NCI by the National Cancer Act. Reception
Pictured above, left: Congressman Jim Matheson (D-UT,2nd) Dr. Stephen Prescott (Director of the Huntsman Cancer Center, Utah) and Marlene Malek, President of FOCR. Pictured above right: Senator Inouye and Dr. Lester Crawford. Senator Orrin Hatch (R-UT) (pictured at left) also made remarks at the reception and several other members attended including Senators Tom Harkin (D-IA), Senator Daniel Inouye (D-HI), Senate President pro tempore Ted Stevens (R-AK), and Congressman Jim Matheson (D-UT-2nd). Acting FDA Commissioner Dr. Lester Crawford and Acting Deputy Commissioner Dr. Janet Woodcock also attended. All pictures from April 5th events were taken by Mike Gatty of DCEventPhotos. FOCR and NPAF Respond to Senate HELP Committee Questions on Safety Issues On March 1 of this year, Friends of Cancer Research and the National Patient Advocate Foundation partnered to present testimony on drug safety concerns before the Senate HELP Committee. As a follow-up to that testimony, the Chairman Enzi (R-WY) submitted 2 questions in writing the responses to which were included in the public record. Below are the questions and a highlight from the response. To read the responses in their entirety, please click here. Also, please click here to view the complete testimony. 1) In light of recent controversies, some people have proposed requiring longer-term and larger studies of drugs before they are approved. Could you comment on whether and how this might impact patients? Time is a highly precious commodity to someone diagnosed with a life altering and/or life threatening condition like cancer, AIDS, or diabetes. The diagnosis not only impact the patient, but also their families, friends and communities. When you are suffering from a potentially fatal or severely debilitating disease, you shouldn’t have to wait any longer than is necessary for the FDA to approve new medical products. Any attempt to mandate longer or larger clinical trials would obviously increase the length of time before patients would have access to new products if they are deemed safe and effective. When you are suffering and dying, the risk/benefit ratio of significantly different than in patient populations in other circumstances. 2) Many have called for a greater separation between the Office of New Drugs, which is responsible for drug approvals, and the Office of Drug Safety, which is responsible for post-market surveillance of drugs that have already been approved. Are you concerned that an independent Office of Drug Safety would only look at risks and problems, potentially ignoring the benefits? Patients and their families, physicians and caregivers must always weigh the benefits and risks associated with a particular treatment option. Similarly, we feel that the FDA must carefully weigh the benefits and risks associated with a new drug when making decisions about approval or post marketing activity. Safety and efficacy are the inseparable foundation of the FDA’s ability to best define the appropriate risk/benefit ratio of a product. Risk cannot be considered separately from benefit, nor safety from efficacy. To review one without an equal measure of the other could easily lead to misjudgments and false conclusions. For that reason, we would advise against any effort that creates new regulations or bureaucracy that isolates or further separates the drug safety function from the overall drug review and monitoring process. For the full responses, please click here. NIH Update: Appropriations and Conflict of Interest Debate Based on concerns that the current $28.8 billion NIH budget request would reduce the number of grants funded and slow down the pace of discovery in promising scientific fields, Senator Arlen Specter (R-PA) in mid-March proposed an amendment to the FY 2006 budget resolution that would provide an additional $1.5 billion appropriation for NIH. The amendment passed the Senate by a vote of 63 to 37. However, the NIH total included in the Senate’s budget resolution of $29.9 billion now differs substantially from the $28.8 billion included in the House’s budget resolution approved by the Budget Committee on March 10th. On a related front, some in the Congress are growing concerned that the new rules put in place by NIH regarding ethical restrictions go too far and are actually driving some of the best and brightest away from NIH. According to a recent article by Emily Heil in the Congress Daily, some senators “fear that the new rules, which were announced in February, are prompting scientists to leave the agency and might harm recruitment.” Senator Tom Harkin (D-IA) told NIH Director Elias Zerhouni at an April 6th Labor-HHS Appropriations Subcommittee hearing that the new rules are “too onerous, and they must be redone, soon before you lose more people." At the annual Early Detection Research Network (EDRN) Meeting held this past month in Maryland, Dr. Ellen Sigal, on behalf of FOCR, gave a presentation on the importance of advocacy in the scientific community. Dr. Sigal serves on the Steering Committee for EDRN, a program sponsored by the Division of Cancer Prevention of the National Cancer Institute which oversees the transition of new research findings from the laboratory into medical practice in the areas of early cancer detection and risk assessment. Dr. Sigal is scheduled to make two major presentations on behalf of FOCR at the upcoming American Association of Cancer Research (AACR) annual meeting in April. Dr. Sigal will speak to the changes occurring with the FDA's new Office of Oncology as part of a larger discussion on science policy and legislative affairs.
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