Aggressive marketing of MRI for breast cancer screening by AmeriScan™ incensed breast imagers for years because the manufacturer exaggerated the accuracy of the technology in a widely distributed series of Internet, television, radio, and newspaper ads. The original ad claimed 100 percent accuracy, although—with pressure from the FDA—that was revised to “almost 100 percent.” Even that is an overstatement because most people presume that accuracy includes both specificity and sensitivity. Although the sensitivity of MRI is very high, specificity is relatively low and MRI does not reliably detect microcalcifications.
Although some breast MRI applications are supported by the literature, screening is not one of them. MRI has been proven effective for uses such as evaluating women with breast implants that may have ruptured. It is also used for women known to have breast cancer to evaluate the extent of tumors prior to surgery, or after surgery to monitor response to treatment.
After several years of outcry among breast imagers, the Medical Board of California and the San Francisco District Attorney’s Office jointly filed a lawsuit in San Francisco Superior Court on October 23, 2003, against the founder and medical director of AmeriScan.™ Less than two weeks later, AmeriScan™ announced its closure.
the outcome of presentations at high-profile scientific meetings that received mass media coverage and found that in as many as one in four of these presentations the findings were never published—which means that they were never subjected to peer review, or they were and failed. 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
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. The committee supplemented its expertise through several workshops, which were organized as information-gathering, brainstorming sessions (see Appendix B for