The Cancer Letter’s coverage of the controversy over a commonly used gynecological procedure focused on three themes: 1) The devastation power morcellation caused to real people. Ong followed two Boston couples whose lives were turned upside down after being harmed by the surgery, performed at one of the world’s best medical centers: Brigham & Women’s Hospital. One of the two women died of metastatic uterine cancer, the other miraculously survived. 2) The flaws in the FDA device clearance process that allowed morcellators to become a mainstay of American medicine, particularly in OBGYN. 3) Brigham’s effort to save the procedure by initiating an ethically questionable study that combined the offending device with a “containment bag.” The clinical study was enrolling women even though it was not properly cleared by FDA. Aggressive investigative coverage in The Cancer Letter left Brigham no choice but to stop the study. The series utilized various tools and media to provide comprehensive reporting on power morcellation– statistical analyses, photography, and an interview documentary. The Cancer Letter provided the most detailed and thorough information on the issue, setting the standard for other publications to follow. Power morcellation was, in early 2014, a routine procedure used to remove uterine tissue through small incision sites. The morcellator consists of a hollow cylinder with powered blades that breaks tissue into fragments. The procedure was performed in an estimated 100,000 women annually in the U.S. The gynecology community had known that the morcellator, which has been in use for fibroid removal and hysterectomies for nearly 20 years, could increase the risk of spreading undetected cancer. However, gynecologists had assumed that uterine sarcomas were extremely rare, and that the benefits outweighed the risks for the vast majority of women with fibroids, which are largely benign tumors. That assumption was fundamentally challenged by Hooman Noorchashm and Amy Reed, two physicians who were at the time employed at Harvard-affiliated institutions. Reed underwent power morcellation at Brigham & Women’s Hospital on Oct. 17, 2013. Within a few weeks, her previously undetected leiomyosarcoma had metastasized in her abdominal cavity. Reed and Noorchashm, her husband, put two and two together and confronted Brigham. The couple discovered they were never informed that power morcellation was the surgery of choice, and that they were never warned of the risk of upstaging cancer. They also discovered that some physicians at Brigham had known of a risk ratio approximate to FDA’s estimate, not long before Reed’s surgery. Angered by the responses they drew from Brigham, Noorchashm and Reed waged an international campaign against power morcellation, and put the issue on FDA’s to-do list in a matter of months. While Reed was recuperating from her treatments, another patient, Erica Kaitz, was dying. Kaitz had undergone the same procedure shortly before Reed at Brigham. Her husband, Richard Kaitz, a Boston attorney and a prolific donor to Harvard, was desperately looking for ways to save her. Ong delved into the personal narratives of the two couples, examined the FDA 510(k) clearance process, and analyzed scientific evidence as well as FDA action on the issue. The Cancer Letter provided in-depth coverage of each key event in the timeline of the controversy–from the genesis of the story, to the end of widespread use of the device.
