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careers. By combining their clinical and research skills, these specially trained individuals become critical links for translating basic scientific discoveries into clinical research that ultimately benefits patients and reduces cancer incidence and mortality.
The By-Pass Budget includes a request level of $13 million. These resources would permit NCI to provide significantly greater incentives for young physicians to pursue research careers in cancer, The President's Budget of $8.8 million will permit maintenance of the existing program.
GRANT REVIEW OF CLINICAL STUDIES
Question. I understand physician scientists often have a tough time competing for research grants, in part because the study sections to which their proposed projects are assigned have limited expertise in clinical research. How does NCI, in conjunction with the NIH Division of Research Grants, intend to address problems related to grant review of clinical studies?
Answer. The NCI has reached an agreement with the Division of Research Grants (DRG) whereby an expansion of committee membership for review of clinically oriented research grants will be made concomitantly with an anticipated increase in investigator-initiated research project applications. The Experimental Therapeutics 2 Study Section, which reviews the majority of such applications, will add three new members with clinical qualifications. To further increase the number of clinical reviewers, NCI and DRG staff also have nominated additional individuals, with clinical qualifications for service in the NIH Reviewers' Reserve, where they may be called upon to serve as full voting members of chartered Initial Review Groups, as needed, to review clinical research projects. Over the longer term, as the volume of clinical research applications increases, the Division of Research Grants will consider the chartering of an Initial Review Group specifically to review clinical studies of cancer research.
REIMBURSEMENT OF PATIENT CARE COSTS
Question. As third-party payers including Medicare continue to tighten cost controls, medical specialty organizations have reported increased difficulty getting reimbursement for patient care costs associated with so-called "experimental" treatments. In your testimony before this subcommittee in 1989, you made very clear that NCI "strongly supports the idea that treatment with investigational therapy in scientifically meritorious clinical trials is standard therapy for cancer patients for whom no reliable curative therapy exists." Are NCI grantees continuing to encounter problems in securing reimbursement for the patient care costs associated with clinical research?
Answer. Investigators continue to confront varying degrees of difficulty in obtaining coverage for the patient care costs associated with NCI-sponsored clinical trials. It is difficult to quantify the problems due to the decentralization of the insurance industry. Coverage decisions vary from one geographic location to another and from one insurer to another. However, in a recent
survey of 200 oncologists which was released March 7, 1991, 41% of the physicians reported that reimbursement for clinical trials has declined in the past year.
Documented examples of reimbursement issues regarding patient care costs which have occurred in important areas of research include: first, denials of a Phase II trial of taxol which was conducted at Johns Hopkins University in women with ovarian carcinoma refractory to platinum; second, denials of Group C agents despite a statement of coverage by Medicare; third, denials of bone marrow transplant for Stage IV breast cancer in women who are participating in peer reviewed, scientifically valid clinical trials.
NCI continues to support reimbursement for patients enrolled in scientifically meritorious clinical trials and to this end, NCI is actively working to promote a dialogue with insurers to better meet our joint goal of providing more effective treatment for cancer patients. NCI believes that the recent initiative of Blue Cross-Blue Shield supporting the patient care costs for their subscribers enrolled in NCI - sponsored High-Dose Chemotherapy/ Autologous Bone Marrow Transplantation (HDC/ABMT) trials is a step in that direction.
If so, how will this impede scientific progress?
Answer. Continued reimbursement denials will have a profound effect on the development of new therapies. If insurers will not cover the patient care costs of a trial, accrual to that study will be slowed and completion will take much longer than projected. Restricted reimbursements may also limit the number of trials that can be done at excellent cancer research Institutions. Both of these constraints will ultimately delay the identification of new, efficacious therapy. A restrictive system will potentially evolve in which only those who can afford to pay will have access to the new, innovative therapies which cancer clinical trials offer.
QUESTIONS SUBMITTTED BY SENATOR ARLEN SPECTER
HEALTH EFFECTS OF HIGH VOLTAGE POWER LINES
Question. Dr. Broder, the residents of South Scranton, Pennsylvania are deeply concerned over the health effects of high voltage power lines which run through their community. Community residents report an elevated incidence of cancer.
What message should I bring back to the people of South Scranton regarding this serious matter?
Answer. As you may know, power transmission lines produce electromagnetic fields (EMF). The energy from these fields is in the form of extremely-low-frequency (ELF) waves. These waves are also produced by other devices, such as household appliances and electric blankets. Unlike extremely-high-frequency waves, such as X-rays and ultraviolet light, ELF waves have not been proven to cause cancer.
Human epidemiologic studies of EMFs and cancer have been inconsistent and inconclusive. Findings from studies in Colorado and Sweden, which suggested a small increase of cancer in children and adults living near high-voltage transmission lines, were not confirmed in similar studies from Rhode Island, Washington State, and England. More recent studies in Denver and Los Angeles suggest an increase of childhood leukemia associated with living near high voltage power lines. However, the associations were with wire code configurations (diagrams showing increasing levels of current-carrying capacity) as a surrogate for EMF exposure levels. No consistent risk for childhood leukemia was seen in homes where actual EMF measurements were made.
Thus, it has been very difficult to evaluate reliably the health effects of exposure to electromagnetic fields. The studies conducted to date have been conflicting and inconclusive, and a connection between electromagnetic fields and cancer has not been established. One problem is the great difficulty in estimating an individual's exposure to electromagnetic fields.
Question. What is the status of my request that a health effects study be conducted included in my letter to you of February 13, 1991?
Answer. Childhood leukemia is the health condition most often related to exposure to electromagnetic fields from power transmission lines. Because of this NCI is conducting a national, multicenter study in collaboration with the Children's Cancer Study Group to determine whether electromagnetic fields might be causally related to childhood leukemia. Leading hospitals and cancer centers in Pennsylvania are included in the study. These large referral centers would treat most of the cases of childhood leukemia diagnosed in the state, including Scranton. The centers include the Children's Hospital of Philadelphia, the Children's Hospital of Pittsburgh, and the Hershey Medical Center.
CANCER INCIDENCE AND MORTALITY AMONG MINORITIES
Question. Dr. Broder, I understand that there is an alarmingly high incidence and mortality of cancer among minorities, particularly. What are the reasons for this disparity?
Answer. The extent to which Blacks experience higher cancer mortality than whites is striking--especially among Black males, where the risk of dying of cancer is 38 percent higher than for white males. The difference among Black and white males stems from both higher cancer incidence as well as poorer survival among Blacks. Although the cancer incidence rate for Black females is slightly less than the rate for white females, the large difference in survival leads to a considerably larger mortality rate among Black females than among white females -- Indeed, 14 percent higher mortality. Overall differences in cancer experience between Blacks and whites are summarized in the following table.
Differences in Cancer Incidence, Mortality and Survival
By Race for Selected Time Periods?
?(Note: Incidence and mortality rates are per 100,000 and are age-adjusted to the 1970 U.S. standard population.)
With respect to cancer trends, for Blacks, the age-adjusted incidence rate for all sites combined and both sexes has increased from 347.5 per 100,000 in 1973-4 to 404.2 in 1987-8, a relative increase of 16.3 percent. For whites, the increase of the corresponding rates has been from 325.6 in 1973-4 to 380.2 in 1987-8, a relative increase of 16.7 percent. of particular interest is the fact that the rate for Blacks in 1987-8 is six percent larger than the rate for whites. The fact that part of the difference in the incidence rates between Blacks and whites is due to smoking-related cancers suggests that the potential exists for reducing the cancer burden in Blacks by appropriate targeting of cancer control programs.
The trend among Blacks in cancer mortality differs from that among whites. Among whites the rate increased from 159.8 to 168.3 from 1973-4 to 1987-8, a total increase of 5.1 percent. For Blacks, however, the rates increased from 195.3 to 214.0 over the same period, an increase of 9.5 percent.
of the ten combined cancer sites, the five-year survival rates for Blacks are lower for six cancer sites for all stages combined, colon and rectum, lung and bronchus, female breast, cervix uteri, corpus uteri, prostate gland, and urinary bladder and for all cancer sites combined. Black males had a five-year survival rate 29 percent lower than white males and Black females had a five-year relative survival rate 23 percent lower than that of the white females. Few significant survival differences are noted by stage of disease except within the regional stage for colon and rectum, lung and bronchus, female breast, and cervix uteri, distant stage for urinary bladder among males and local stage for females with cancer of the urinary bladder. Black females have a significantly poorer survival within each stage for cancer of the corpus uteri.
Being diagnosed in a more severe stage of disease greatly reduces the effectiveness of therapy and the chances for escaping death due to cancer. Blacks have a tendency to be diagnosed in a more advanced stage of disease at diagnosis than whites. of the ten cancer sites, Blacks, in general, are detected in a later stage than whites for seven cancer sites--colon and rectum, lung and bronchus, female breast, cervix uteri, corpus uteri, prostate, and urinary bladder.
There is some evidence that differences in socio-cultural and perhaps biological factors may explain part of the survival differences observed between Blacks and whites. We know, for example, for cancer as well as other diseases, that low income and under-educated persons have a poorer survivorship than upper income and better educated persons. Some of the reasons revolve around the lifestyle associated with living in a poor environment such as: the ability to pay for health care without comprehensive medical insurance; a knowledge of and recognition of cancer signs and symptoms; delay in seeking and receiving definitive medical care; the existence of other medical problems; and compliance with treatment regimens.
In four primary cancer sites--female breast, colon, corpus uteri, and urinary bladder, the NCI is conducting a case-control study to assess the extent to which lifestyle, care secking, compliance to treatment regimens and other factors influence the Black-white differences in cancer patient survival. Patient accrual is from three urban areas and was complete as of December, 1987. It is too early in this study to perform definitive analyses, because the patients are still being followed for the assessment of their vital status. It is expected that survival analyses will commence within the next two to three years and that this trial will provide some insightful information into the reasons for some of the observed Black-white differences in cancer patient survivorship.
Question. this problem?
What action is the Institute taking to address
Answer. The National Cancer Institute has formulated an intervention research program to identify and test, in community settings, interventions to reduce the cancer rates in minority populations The initial focus was on Black populations but has more recently expanded into additional efforts for the Hispanic and Native American populations of American Indian, Alaska Native, and Native Hawaiian.
Many initiatives have been directed to specific populations. Specifically, for the Black population, eight contracts for intervention research specific to cancer in Black populations have been implemented. This research program is currently comprised of two components: studies to reduce avoidable mortality and studies to prevent the onset of smoking and/or to effect widespread smoking cessation. These projects are in their fifth year of support.
The formulation, approval, funding and award of a number of grants for intervention research specific to cancer in Blacks and other minority populations, including low-income groups, have also been initiated.
Initiatives to reduce avoidable mortality have been implemented. These projects seek to identify key factors that contribute to avoidable mortality from specific cancer sites, implement interventions to reduce mortality from the identified sites, evaluate the effectiveness of such interventions in a defined population, and identify prototype approaches to the reduction of avoidable mortality for widespread dissemination