Pharmaceutical

Report questions financial ties between FDA advisors and power morcellator makers

morcellator Report questions financial ties between FDA advisors and power morcellator makersAn advisor for the Food and Drug Administration (FDA) who sat on a panel in July to review serious safety concerns involving a surgical tool known as a power morcellator had received tens of thousands of dollars from manufacturers of the tools from 2009 to 2013, according to an investigation by The Wall Street Journal.

Laparoscopic power morcellators are devices used to mince uterine growths or entire uteruses inside the body and remove them through a small incision in the abdomen. The tools have become favored by many doctors because they are less invasive, offer shorter recovery and leave less scarring than traditional open hysterectomies or myomectomies (the removal of uterine fibroids).

Within the past year, concerns have been raised about the safety of power morecellation for gynecological surgeries. Uterine fibroids are benign, but in rare cases a type of uterine cancer known as uterine sarcoma could be present. In these cases, morcellation can send bits of cancerous tissue throughout the abdomen, seeding additional tumor growth, making the cancer more difficult to treat thus worsening the odds or survival.

There is no reliable way to detect uterine sarcoma until the uterus or fibroids have been removed. Under pressure from advocacy groups and individuals, the FDA launched an investigation into the spreading cancer risk, calling on a panel of medical experts to review the information and offer a recommendation.

Keith Isaacson, a doctor who served on the FDA’s advisory panel, has reportedly been paid $12,000 in consulting fees from Johnson & Johnson in 2013, which sold one of the most popular power morecellators through its subsidiary Ethicon, Inc. The company just recently announced it was discontinuing sales of its morcellators.

Dr. Isaacson also reportedly was paid $9,500 by Johnson & Johnson from 2010 through 2013. He was also paid $148,400 in consulting fees and other compensation from Karl Storz, another company that manufactures power morcellators.

Just before the panel convened in July, another doctor, Andrew Brill, removed himself from the panel after The Wall Street Journal reported that he had received $100,000 in consulting fees from Johnson & Johnson in 2013.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does. In November, the agency issued a safety advisory discouraging use of power morcellation in the vast majority of women. Lawsuits have also begun to mount against manufacturers of the devices.

Source: Engineering.com