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1 Introduction
Pages 19-36

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From page 19...
... Some breast cancers are lethal, and each year about 40,000 women and 400 men die from breast cancer in the United States. Others are not fatal, and some women diagnosed with breast cancer will needlessly undergo mastectomies, chemotherapy, and radiation.
From page 20...
... Despite the common misconception, screening mammography does not benefit women by reducing their risk of breast cancer, but rather by reducing mortality through detecting breast cancer at earlier and more treatable stages. BOX 1-1 Millions of Women Do Not Receive Annual Mammograms In 2002, approximately 60.5 percent of women aged 40 to 64 received mammo grams in the United States.
From page 21...
... Thus far, the accuracy of digital mammography has been shown to be equivalent to, but not superior to, traditional film-screen mammography, although clinical studies are still under way.14 There have also been changes relevant to breast cancer detection that are only indirectly related to technology developments. First, the sense of crisis concerning the shortage of breast imagers has deepened, and mammography facilities continue to close.
From page 22...
... INVESTING IN RESEARCH Fostering the invention and early stage development of medical technology is essential and depends on the nurturing of basic medical research. With the possible exception of AIDS, breast cancer research receives more funding than any other disease -- due, in no small part, to the long-standing and tireless efforts of breast cancer activists.
From page 23...
... Most clinical studies for cancer detection are designed to evaluate a single new technology and do not provide the data that permit evidence-based choices among different options or how to sequence those options to maximize overall efficiency and effectiveness.d Rather than evaluating each technology only on its own, dThere are some notable exceptions such as the research being done by Mitch Schnall, Keith Paulsen, and their colleagues.
From page 24...
... They were also asked to analyze the steps in medical technology development relevant to breast cancer detection technologies, including the policies that influence technology adoption. The previous committee thus provided an overview of current and near-term technologies for breast cancer detection and outlined the long and arduous path from invention to adoption of new technologies (Table 1-1)
From page 25...
... This report also builds on the work of the previous committee by analyzing what improvements or innovations in breast cancer detection and diagnosis will have the greatest impact on reducing the toll of breast cancer, and what can be done to foster those improvements (see the statement of task in Box 1-2)
From page 26...
... 26 SAVING WOMEN'S LIVES TABLE 1-1 Continued FDA Technology Description approved* Scintimammography Sense tumors from gamma-ray Yes emission of radioactive pharmaceutical Thermography Seeks tumors by infrared signature Yes Electrical impedance imaging Maps the breast's impedance with Yes low-voltage signal Optical imaging Localizes tumors by measuring scattered near-infrared light Electrical potential measurement Identifies tumors by measuring potentials at array of detectors on skin Positron emission tomography Forms images using emission Yes from annihilation of positrons from radioactive pharmaceuticals Novel ultrasound techniques Includes compound imaging, which improves resolution; 3D and Doppler imaging Elastography Uses ultrasound or MRI to infer the mechanical properties of tissue Magnetic resonance Analyzes tissue's chemical makeup spectroscopy using radio emissions Thermoacoustic computed Generates short sound pulses within tomography breast using RF energy and constructs a 3D image from them Microwave imaging Views breast using scattered microwaves Hall-effect imaging Picks up sonic vibrations of charged particles exposed to a magnetic field Magnetomammography Senses magnetic contrast agents collected in tumors *
From page 27...
... INTRODUCTION 27 Infrequent Clinical data Clinical data Routine use use suggests a role for .
From page 28...
... analyze the degree to which different stages in the develop ment of innovative medical technologies might act as bottlenecks, particularly for those technologies that promise to improve the early detection of breast cancer. Strategies to improve the efficiency of those steps will be identified and evaluated, with the goal of accelerating the flow of the most promising new approaches from the conceptual stage to clinical practice.
From page 29...
... Thus this report should be of interest to all those who are concerned with the development and application of medical technologies. Its primary audiences, however, are those working to reduce the toll of breast cancer through early detection, including breast cancer activists and women's health organizations; breast cancer researchers; technology developers; clinicians such as breast imagers, primary care physicians, and oncologists; federal, state, and private research sponsors; and those who regulate medical technologies through the FDA, Centers for Medicare and Medicaid Services (CMS)
From page 30...
... Moreover, the technical backgrounds of members of the committee responsible for this report including surgery, radiology, molecular biology, imaging, physics, information technology, and epidemiology should ensure sufficient access to events in the research and development community to assure readers that the committee is not overlooking truly promising new developments. Risk in the Media Research indicates that women tend to overestimate their lifetime risk of developing and dying from breast cancer, and particularly the likelihood of that happening before age 50 (reviewed by Burke and colleagues)
From page 31...
... Many of these direct-to-consumer advertisements encourage readers' fear so as to promote the advertised product or service. Another problematic form of marketing occurs indirectly through media reports of medical developments while they are still "works in progress,"5 such as press releases discussing the content of articles at the time of their publication in medical journals26 and research abstracts from scientific meetings.
From page 32...
... Even press releases of published material can be unreliable. A study of press releases issued by leading medical journals found that the releases routinely failed to mention study limitations or industry funding, and often presented data in formats that exaggerated findings.26 STUDY PROCESS This study was carried out by a committee on which all major areas of breast cancer detection were represented, including breast cancer screening, diagnosis, and treatment; clinical trials expertise; cancer and molecular biology; medical technology development and evaluation; health care administration; and technology innovation and adoption.
From page 33...
... The committee also heard from the leaders of several of the most important clinical studies aimed at improving systems for the early detection of breast cancer. Finally, the committee heard from senior staff at the federal agencies that regulate the availability of new medical technologies, as well as representatives of private insurance, who also serve as gatekeepers.
From page 34...
... Existing technologies that can compensate for the technical limitations of mammography are also discussed. Chapter 4 discusses what is known about breast cancer risk factors, how risk perception is often confused, and how improved knowledge about breast cancer risk factors could be used to develop individualized strategies for breast cancer detection.
From page 35...
... 2001. Comparison of full-field digital mammography with screen film mammography for cancer detection: results of 4,945 paired examinations.
From page 36...
... 2002. News media coverage of screening mammography for women in their 40s and tamoxifen for primary prevention of breast cancer.


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