FDA: Expert Panelist on Morcellators Out Due to Conflict of Interest
Mesh News Desk, July 31, 2014 ~ Two days before an advisory panel was gathered to look at the controversial medical device called a morcellator, a gynecologist stepped down due to conflict of interest.
San Francisco gynecologist, Andrew Brill, MD, was supposed to join the 126-member panel July 10. Turns out Dr. Brill was the recipient of consulting fees from the very device makers he was set to review.
A Food and Drug Administration review caught the conflict. The fees were not a cup of coffee.
Johnson & Johnson provided Dr. Brill with nearly $100,000 in consulting fees in 2013, reports the Wall Street Journal. The general cutoff defining a conflict is about $50,000 under the FDA’s guidelines, depending on how much the consultant is needed to the advancement of the device.
Other panelists scheduled for the power morcellator panel were also found to have conflicts including one from Boston who had received $12,000 in consulting fees and another from Georgia who was previously a consultant for J&J and received a grant from the company. He refused to tell the Journal how much he received.
The WSJ blog Pharmalot has the complete story here.
Ethicon, a division of J&J, makes one morcellating device, a tool that essentially goes into a woman’s uterus and grinds up fibroids. The procedures has the potential to spread previously undiagnosed cancers that may be masking as fibroids or contained within the growth.
Morcellators are used in about 50,000 hysterectomies a year, with about 40% used to rid the uterus of fibroids.
Since the very public case of Amy Reed, a medical doctor now fighting cancer, J&J has pulled its morcellator from the market.
An FDA spokesperson told the WSJ that Dr. Brill received just too much money to pass the conflict-of-interest threshold established for panel members. J&J values Dr. Brill as an educator to others about J&J’s women’s health products. He is a “recognized leader in the field.”
When asked to reveal the potential conflicts of other panel members, the FDA declined citing privacy laws.
In April, the FDA said the risk from the morecellation process, formerly thought to be small, was actually higher than previously thought.
Readers of Mesh News Desk may be familiar with Dr. Andrew L. Brill. He was one of the panelists on the expert panel appearing in September 2011 to determine the fate of pelvic mesh. The minutes from the September 8, 2011 meeting are here.
The minutes from the September 9, 2011 meeting are here.
Experts on that panel failed to reclassify pelvic mesh though last month did ask for public participation to reclassify pelvic mesh for prolapse into a Class III implant that would tighten restrictions and require proof of safety and efficacy before it could be sold. The proposal did not address mesh for incontinence.
But the question remains – Did Dr. Brill do most of his consulting work between 2011 and 2014? See Dr. Brill’s CV here:
Wall Street Journal
More from the WSJ:
More fhttp://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226?mod=rss_Health&cb=logged0.46765525937466035; http://online.wsj.com/news/articles/SB10001424052702304432604579473362527708066?mg=reno64-wsj
Dr. Brill’s Positive Patient Review:
His FDA CV: