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 field.
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 before surgery.
Jon Kamp contributed to this article.
Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp
at jon.kamp@wsj.com
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