By Dow Jones Business News,
July 10, 2014, 04:19:00 PM EDT
By Jennifer Levitz
SILVER SPRING, Md.--A member of an independent panel weighing the safety of a medical device that can spread cancer
in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he had accepted from a device
manufacturer, the agency said Thursday.
San Francisco gynecologist Andrew Brill removed himself from the 16-member panel before two days of hearings on the
device were set to begin Thursday, an FDA spokesman said. Dr. Brill didn't respond to requests for comment.
In 2013, he received nearly $100,000 in consulting fees from Johnson & Johnson subsidiary Ethicon, according to
J&J's website. Ethicon is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The
advisory panel is expected to make a recommendation to the FDA about whether morcellators, used in an estimated 50,000
hysterectomies a year, should be more tightly regulated or even used at all.
"The FDA has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings.
During the course of the agency's review and in consultation with Dr. Andrew Brill, it was determined that the financial
information he disclosed was just above the threshold established for panel members to participate in one of our
meetings," an FDA spokeswoman said.
The Wall Street Journal first asked the FDA and Dr. Brill about the consulting fees on Tuesday after comparing
publicly released names of the members of the panel with a list of paid consultants on J&J's website and other public
documents. The agency declined to speak until Thursday morning.
J&J, the only manufacturer that releases names of its paid consultants, said Dr. Brill has done professional
education consulting for them in their women's health and energy businesses and that he is a recognized leader in the
The FDA assembles its own advisory panels and requires members to report any financial interests members might have
in the subject matter. The agency declined to release disclosure statements submitted by morcellator panel members,
citing privacy laws. In evaluating potential conflicts, the test is whether "the need for the individual's services
outweighs the potential for a conflict of interest created by the financial interest involved," FDA policy says.
At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website
and other public documents.
Michael P. Diamond, a Georgia gynecologist and acting chairman of the FDA panel meeting on morcellators, was
previously a consultant for Ethicon and received a grant from the company, he said Thursday in response to a question
from the Journal. He declined to say the amount he received.
Keith Isaacson, a Boston gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. His work
for the company has been as a "professional-education consultant," a J&J spokesman said. A spokesman for Dr. Isaacson
wasn't available for immediate comment.
Both doctors remain on the panel.
Laparoscopic power morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy,
so they can be removed from the body through small incisions. But in some instances, the devices can spread a rare but
dangerous cancer that masquerades as benign fibroids.
The risk had been known for years but was believed to be extremely small. In April, the FDA said the risk was
higher than previously thought and discouraged doctors from using morcellators while it considered a more permanent
position on the tools.
The hearing drew a crowd of patients, relatives, doctors and industry representatives.
"Because morcellation upstaged her cancer, Elizabeth never had a chance, " Joanne Jacobson told the panel about her
sister, who died from cancer in January 2013 following a morcellation procedure, according to her medical records.
JoAnn Trainer urged a ban on cutting tissue inside the body while speaking on behalf of her daughter Amy Reed, a
Boston physician whose post-morcellation cancer case triggered alarm that led to this week's meeting. Dr. Reed, sitting
in the audience with her family, plans to speak Friday.
The head of the influential American College of Obstetricians and Gynecologists argued that taking away
morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as bleeding and
infection. "It is unacceptable that in an effort to avoid one risk, we subject women to another," ACOG Chief Executive
Hal C. Lawrence III told the panel.
J&J halted all sales shortly after the FDA advisory in April. Piet Hinoul, vice president of medical affairs at
Ethicon and a gynecologist, told the panel the company stands by this decision until there is consensus in the medical
community about how to mitigate the risk.
He also argued against tougher regulation, which the panel is expected to discuss Friday. Dr. Hinoul urged instead
efforts to better identify women who could be more at risk of harboring cancer. The cancer can't be reliably detected
Jon Kamp contributed to this article.
Write to Jennifer Levitz at email@example.com and Jon Kamp at firstname.lastname@example.org
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