November 12, 2003
Senator Edward M. Kennedy (D-MA); Senator Ted Stevens (R-AL); Senator Arlen Specter (R-PA): Dr. Andrew von Eschenbach, National Cancer Institute; Dr. Mark McClellan, Food and Drug Administration; Dr. Charles M. Balch, American Society of Clinical Oncology; Judge Ralph Burnett, District Court of Maryland; Dr. Nancy Davidson, Johns Hopkins University School of Medicine; Dr. Susan Desmond-Hellmann, Genentech; Dr. Gerard Thomas Kennealey, AstraZeneca; Dr. H. Kim Lyerly, Duke University Medical Center; Dr. Mel Sorensen, GlaxoSmithKline; Charlene Gaddy Wallace, Catholic University of America; Dr. Ellen Sigal, Friends of Cancer Research; Marlene Malek, Friends of Cancer Research.
In 1971, Congress passed the National Cancer Act and thereby committed this nation to a major assault on cancer. In that year, there were 3,000,000 American cancer survivors; today, there are more than 9,000,000. But 3 million new cases of cancer will have been diagnosed in the United States by the end of 2003, and cancer continues to kill an average of 1,500 Americans every day.
The implication of those two sets of numbers – the continuing tragedy of cancer and the impressive strides that have been made in controlling it – lay behind the conference entitled "Confronting Cancer Now" that was convened by the Division of U.S. Studies and Friends of Cancer Research on November 12.
Three major themes emerged from the presentations. The first was that the elimination of cancer may remain a dream but it is no longer a fantasy. Dr. Andrew von Eshenbach, Director of the National Cancer Institute (NCI), stated that NCI's goal is "to eliminate the suffering and death due to cancer by 2015." That could be made possible by the exponential expansion of scientific knowledge and new enabling technologies such as genomics, proteomics, metabolomics, molecular imaging and nanotechnology. Dr. Susan Desmond-Hellmann, Chief Medical Officer and an Executive Vice President at Genentech, emphasized the enormous increase in the pace of cancer care discoveries during the last five years, particularly in the area of targeted therapies. According to Dr. Mel Sorensen, Vice President of Oncology-MSI, Clinical Development & Medical Affairs at GlaxoSmithKline, many of the details of the mechanisms of cancer have been uncovered during the last 10 to 15 years, allowing exciting new approaches to blocking cancer growth.
A second and related theme, also introduced by Dr. von Eshenbach, was that the approach to cancer has changed and must continue to do so if the war against cancer is to succeed. Dr. H. Kim Lyerly, director of the Duke Comprehensive Cancer Center, noted that cancer is in fact many different types of diseases with common clinical characteristics – what Dr. von Eschenbach called a family of diseases - which suggests the need for a wide variety of therapies and drugs. The consensus, however, was that the best approach is one that will stop cancer before it starts, and Dr. von Eshenbach described a shift in cancer treatment from "seek and destroy" tactics to a preemptive strategy of preventing cancer from becoming lethal. Scientists now view cancer as a disease process, with mechanisms that are vulnerable to intervention. Dr. Desmond-Hellmann described the "Angiogenic Switch," the mechanism that allows small dormant tumors to become vascular tumors with metastatic potential. One challenge is to intervene so as to stop that process. But steps can be taken even before the process begins, according to Dr. Mark McClellan, Commissioner of the Food and Drug Administration (FDA), and prevention is far more important than treatment. Prevention includes not only medical and genetic strategies but teaching people that their daily lifestyle decisions, especially in the area of diet, have important implications for cancer prevention. Dr. McClellan suggested partnerships with food-production companies to make the relevant dietary options widely available.
A third theme was the necessity to provide adequate resources for the fight against cancer. The roadblocks are numerous, and include bureaucracy and territoriality. Senator Edward Kennedy, whose son and other family members are cancer survivors, reminded the audience of the bureaucratic resistance to the creation of NCI as a separate institution within the National Institutes of Health (NIH). Dr. Nancy Davidson, Professor of Oncology at the Johns Hopkins University School of Medicine, spoke of the lengthy time required to secure approval of clinical trials, because of the many regulatory agencies that must sign off. Dr. Gerard Thomas Kennealey, Astra-Zeneca's director of Global Products for Faslodex, indicated that one reason for the delays may be the number of divisions within the FDA, with inconsistent agendas and procedures. Dr. Sorensen, noting that only three out of 10 marketed cancer drugs will produce a profit that will match or exceed the average research and development costs needed to create those drugs, and Dr. McClellan, stating that fewer than one out of two Phase Three clinical trial drugs – those at the end process of the clinical trial procedure – will result in an application to the FDA for marketing approval, indicated that the amount of money and risk involved in such research necessarily affects the activities of private industry.
Greater government funding for research and treatment is crucial, the speakers agreed. "Families in this country are entitled to have their priorities reflected in the national budget," Senator Kennedy declared. But, as Senator Arlen Specter commented, it is difficult to secure additional funding for NIH and for such promising techniques as stem cell research. One deterrent is the huge amounts of money needed for research into and the treatment of cancer, as opposed to efforts aimed at less costly and more immediately responsive diseases; another is the current emphasis on the financial demands of the war on terrorism. Senator Ted Stevens, a cancer survivor, applauded the recent doubling of the NIH budget but asserted that it is still too small. He called not only for greater government investment in medical research but for Medicare and private insurance coverage of cancer-related diagnosis and treatment, including participation in clinical trials; increased funding for other governmental agencies (e.g. the National Science Foundation, the Department of Defense, the Department of Energy) that are involved in cancer-related research; and broader NIH authority to fund multidisciplinary and multi-institution research.
Dr. von Eschenbach and Dr. McClellan made the first public announcement of two new programs designed to increase the pace and efficacy of cancer research. The first, in the field of information technology, is a joint effort by FDA and NCI to develop clinical trial management software that will put cancer researchers around the country in electronic communication with the FDA and accelerate the regulatory review process for new cancer drugs. The second, the Cancer Fellowship Training Programs initiative, will enable doctors and scientists from around the country to work with cutting-edge therapies in clinical oncology programs at NCI. These initiatives will bring NCI and FDA into even closer collaboration, with hopes of realizing the NCI's goal of eliminating new cancers by 2015.
Philippa Strum, Director of United States Studies (202) 691-4129
November 12, 2003