GAO to investigate FDA regulation of power morcellators.

Government Watchdog to Investigate Hysterectomy Device Found to Spread Uterine Cancer

Government Accountability Office to probe surgical device that was marketed for two decades before FDA issued warnings

By JON KAMP

The U.S. Government Accountability Office confirmed Friday that it plans to investigate a surgical device that was marketed for two decades before the Food and Drug Administration warned it can spread uterine cancer.

Twelve lawmakers wrote the GAO a letter last month asking for a probe into laparoscopic power morcellators, which are bladed, drill-shaped tools gynecologists commonly used to cut up growths called fibroids in minimally invasive surgery, most often hysterectomies. The FDA last year estimated that women who undergo these procedures face 1-in-350 odds that they harbor an undetected cancer that a morcellator could spread and worsen.

“We’ve agreed to do the work,” Katherine Siggerud, managing director for congressional relations at the GAO, confirmed Friday.

In a letter earlier this week to U.S. Rep. Mike Fitzpatrick (R., Pa.), a lawmaker at the forefront of pushing for a GAO review, Ms. Siggerud said the agency accepted his request “as work that is within the scope” of GAO authority. She said the GAO would likely have the staff available to begin its work in about five months.

She said in an interview it was too soon to tell how long a probe might take. An FDA spokeswoman said the agency will cooperate with any GAO review, and does not comment on pending or ongoing investigations.

The probe will likely add scrutiny to how the FDA handled issues with power morcellators going back to 1991—when the first one was cleared for sale in the U.S.—to last year, when the agency cited evidence that the risk of hidden uterine cancers called sarcomas was much higher than many gynecologists believed. Device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, but the agency said the magnitude of that risk wasn’t recognized until the issue gained prominence starting in late 2013.

“I am glad the GAO has agreed to take up this investigation,” Mr. Fitzpatrick said in a statement. “What happened with the power morcellator should never happen again.”

Rep. Louise Slaughter (D., N.Y.) and 10 other members of Congress also signed the Aug. 7 letter to the GAO.

They asked for an investigation into issues such as the FDA’s reliance on a regulatory process used to clear all morcellators for sale in the U.S.; the process has drawn criticism for being too lenient. The lawmakers also asked to know whether groups like hospitals and device manufacturers complied with FDA rules to report problems with the devices, how doctors were trained to use them and what steps the FDA is taking to determine whether morcellators are safe to remain on the market.

The FDA has defended the regulatory process used to approve morcellators and most devices as a good way to balance innovation and safety, and said that the agency is strengthening its surveillance of devices on the market. Johnson and Johnson, formerly the largest morcellator maker before it voluntarily left the market last year, has said that it wasn’t aware of any reportable events regarding morcellators and the possibility of worsened cancer until late 2013.

The FDA in November followed up on its earlier morcellator advisory by calling for a black-box warning, its strongest caution, regarding the cancer risks. The devices still remain on sale from other companies beyond J&J, although many hospitals and health insurers have curbed their use.

My comment:  I blog on FiDA Advocate blogspot.  I was trained 9/2010 at the request of FDA/CDRH to be a Patient Representative on medical device Advisory Panels.  CDRH conducts few  Advisory Panels because most (98%) new devices are cleared through the 510(k) process that simply requires the identification of a 'predicate' device and perhaps a payment of $4000.  If an Advisory Panel is called, the FDA/OSHI - Office of Special Health Issues selects the Patient Representative and this person is a NON-voting member of the panel.  Harmed patients and their advocates are rarely a part of the equation and industry has infiltrated the regulatory sphere.  The system is rigged and patient harm-for-profit is the result.  

http://www.wsj.com/articles/government-watchdog-to-investigate-hysterectomy-device-found-to-spread-uterine-cancer-1441385550

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

	JjrkCh #morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas: http://t.co/L3HoWtjxeO 7/10/14, 8:06 AM
	JjrkCh #morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial. http://t.co/AklVXmrvfx 7/10/14, 8:09 AM

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

U.S. NEWS

Doctor Quits Uterine-Device Safety Panel Over Conflict

Move Comes Before Hearing on Cancer Risk From Morcellation Procedure

By JENNIFER LEVITZ And JON KAMP CONNECT

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 jennifer.levitz@wsj.com and Jon Kamp at jon.kamp@wsj.com