The Cancer Letter’s Matthew Bin Han Ong and Paul Goldberg report on how a New Jersey hospital used a misguided study on a robotic surgery to wage an ill-fated war on breast cancer.
What was the Research Site?
The IRB at Monmouth Medical Center approved the study. According to the Cancer Letter authors, the hospital advised the study’s principal investigator, a practicing surgeon with no clinical trials experience, that an FDA review “was not applicable.”
Monmouth, a hospital with over 500 beds, is a teaching affiliate of the Rutgers Robert Wood Johnson Medical School and a member of the RWJBarnabas Health System.
Who was the Lead Investigator?
What was the Study?
The use of the “da Vinci robot” for breast cancer surgery
What was the Problem: Sponsor claims Observational but actually it is Experimental
The study document articulated that the patient was being asked to participate in an observational study as they were planning to undergo a robotic nipple-sparing mastectomy (RNSM) either for preventative or therapeutic purposes. The sponsor noted the procedure had been tested and found to be successful for the treatment or prevention of breast cancer. The IRB documentation noted that the patient wasn’t being asked to participate in an experimental procedure.
However, the FDA had a different position: The regulatory agency of the U.S. federal government had not cleared the da Vinci Surgical System for use in the treatment or prevention of breast cancer. Consequently, the study was experimental.
Apparently a top-tiered institution agreed as well. Memorial Sloan Kettering Cancer Center reached a consensus that the safety of robotic-assisted mastectomy for cancer treatment has not been demonstrated, and researchers at MD Anderson Cancer Center believe that there is enough debate around this topic that a large, multicenter randomized trial should be mobilized to come to the proper truth.
What is the da Vinci Robot?
A system made by the American company Intuitive Surgical. It was approved by the FDA in 2000. It is designed to facilitate complex surgery using a minimally invasive approach and is controlled by the surgeon from a console. The system is commonly used for prostatectomies, and increasingly for cardiac valve repair and gynecologic surgical procedures. It is called “da Vinci” in part because of Leonardo da Vinci’s “study of human anatomy eventually led to the design of the first known robot in history.”