Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, July 11, 2014

J&J $100,000 conflicted FDA panel member on morcellator device?

#morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas:
7/10/14, 8:06 AM

#morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial.
7/10/14, 8:09 AM

Doctor Quits Uterine-Device Safety Panel Over Conflict
Move Comes Before Hearing on Cancer Risk From Morcellation Procedure

Updated July 10, 2014 3:25 p.m. ET
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 Ethicon, a Johnson & Johnson JNJ -0.08% subsidiary that 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 spokesman 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.
At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website and other public documents. The FDA declined to release its own disclosure statements submitted by panel members, citing privacy laws for advisory-committee members.
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 J&J subsidiary 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.
Write to Jennifer Levitz at and Jon Kamp at

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