A history of DMIST and its implications - Limited resources should be better spent

• Published in: Clinical imaging 2021-10, Vol.78, p.301-303
• Main Author: Kopans, Daniel B.
• Format: Article
• Language: English
• Subjects: Breast cancer; Cancer; Cervical cancer; Committees; Digital imaging; Digital mammography; DMIST; Fatalities; FDA approval; Magnetic resonance imaging; Mammography; Medical imaging; Medical screening; Radiography; Womens health
• ISSN: 0899-7071; 1873-4499
• DOI: 10.1016/j.clinimag.2021.06.005

Randomized, Controlled Trials (RCT), the most rigorous tests of efficacy, had proven that mammography screening reduces deaths by early detection. This had been validated in studies that showed that screening in the community also resulted in fewer deaths. Film mammography (FM) had been replaced by Xeroradiography (XM) which had been replaced by Screen/Film Mammography (SFM) which was being replaced by Full Field Digital Mammography (FFDM). The FDA required FFDM to undergo a Premarket Approval (PMA) instead of the usual 510 K required for conversion for other x-ray studies to digital imaging. In addition, the FDA was going to require that even after a PMA, the FFDM systems were going to have to undergo a post approval RCT comparison to SFM. Experience and science were able to convince the FDA that a post-approval trial was not needed, and the requirement was dropped. Congress, however, had earmarked $25 million to support the trial that was no longer required. It appears that the Digital Mammographic Imaging Screening Trial (DMIST) was undertaken to take advantage of the earmarked money and was used to compare SFM to FFDM for cancer detection. The historical issues involved with DMIST provide an important background for the Tomosynthesis Mammographic Imaging Screening Trial (TMIST). Just as the monies for DMIST could have been better spent on an RCT of MRI for screening, the monies for TMIST could be better spent to improve our ability to detect more breast cancers at a time in their growth when cure may be possible. •Full Field Digital Mammography (FFDM) was developed in the 1990’s•For specious reasons the FDA required a Premarket Approval (PMA) and not a simpler 510K for approving FFDM.•FDA, originally, also required a post approval RCT for FFDM and Congress earmarked $25 million in support.•Testimony before the FDA advisory committee explained that a post approval study was not necessary and the trial was dropped.•DMIST wasted $25 million. FFDM and FFDM were comparable. Money could have been better spent on an MRI screening trial.