Mammography and Beyond Developing Technologies for the Early Detection of Breast Cancer: A Non-Technical Summary (2001) / Chapter Skim
Currently Skimming:
Barriers to the Development of Breast Cancer Detection Technology
Barriers to the Development of Breast Cancer Detection Technology
Pages 15-24
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From page 15... ...
,ARRIERS TO T~: DEVELOPMENT OR SREAST CANCER DETECTION TECHNOLOGY The process of developing new technologies for breast cancer detection is quite complex, and several hurdles must be overcome to bring budding technologies to fruition. For example, sponsors of new technologies must have adequate resources for gathering the evidence necessary for FDA approval and for obtaining medical insurance coverage.
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From page 16... ...
Additional problems for researchers using the specimen banks may include issues related to informed consent, privacy, and patents. Women who donate tissue or blood samples to a specimen bank usually sign a general consent form to allow future unspecified research, but occasionally some research projects on the specimens are not approved because the donors did not specifically consent to the given research project.
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From page 17... ...
They suggested that these specimen banks be a funding priority of the government and that the NCI devise and enforce strategies to make it easier to use patient samples in specimen banks. More specifically, the committee recommended that funding for specimen banks include support for the costs incurred by sharing specimen samples with collaborators, and that governmentfunded specimen banks not place excessive restrictions on the use of the specimen with regard to potential future patent rights.
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From page 18... ...
In fact, accuracy comparisons were found to be meaningless when companies tried to show the equivalence of their new digital mammography devices to conventional film mammography devices. This led to a long and costly approval process, during which the FDA changed its requirements several times.
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From page 19... ...
Although both the public and physicians commonly perceive that FDA approval means technologies "work" and should be reimbursed, health care coverage decisions are rarely that simple. FDA approval does not mean that a new device is better than its predecessor, or that it is useful for applications that have not been evaluated.
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From page 20... ...
At the same time, support by NCI and medical insurers would make it easier for technology sponsors to conduct the clinical studies needed to assess whether a new breast cancer screening technology reduces breast cancer deaths. For example, health insurers would cover the costs of performing tests in approved clinical studies, and the NCI and the technology manufacturers would share the other costs involved with the studies.
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From page 21... ...
Dissemination Once a new technology receives FDA approval and insurers agree to reimburse the costs associated with its use, adoption of this technology will ultimately depend on whether consumers and their health care providers find it acceptable, necessary, affordable, and accessible. Experience with x-ray film mammography screening suggests that these factors can be important barriers to a new technology being used by the public.
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From page 22... ...
A lack of health insurance that reimburses the costs of mammography clearly hinders this form of screening. To overcome this barrier, the 1990 Breast and Cervical Cancer Mortality Prevention Act mandated the establishment of the National Breast and Cervical Cancer Early Detection Program.
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From page 23... ...
Currently, only 12-15% of eligible women are served by the program, largely because of a lack of adequate resources. The committee recommended that the CDC screening program be expanded to reach more eligible women.
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From page 24... ...
, which was enacted in 1994, may boost the cost of providing mammography services. MQSA requires all mammography facilities to meet minimum quality standards for equipment and health care professionals, and requires extensive records to show they meet such standards.
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