FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”
“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.
Under Section 803 of Title 21 of the Code of Federal Regulations, manufacturers and hospitals are required to report adverse outcomes—deaths and serious injuries that a device may have caused or contributed to—to FDA within 10 to 30 days.
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Johnson & Johnson subsidiary Ethicon—the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013 (The Cancer Letter, Dec. 18, 2015).
FDA joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the Government Accountability Office and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation,” FDA acting associate commissioner Dayle Cristinzio wrote to Fitzpatrick. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”
Fitzpatrick: An Example for Moonshot FDA Reform
In a letter to Vice President Joe Biden, Fitzpatrick urged the White House to implement “meaningful” reforms as part of the cancer moonshot initiative, which aims to consolidate FDA’s oncology portfolio (The Cancer Letter, Feb. 12).
Medical device reporting regulations need to be strengthened, Fitzpatrick said, and the controversy over reporting of adverse outcomes resulting from power morcellators is one situation where consolidation of cancer expertise at the agency could have life-saving impact.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices,” Fitzpatrick wrote in the April 14 letter. “President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration.
“The purpose of the center is to ‘support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.’ While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.
“Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.”
The correspondence between Fitzpatrick, FDA and Biden can be downloaded here.
The moonshot program aims to provide $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.” (The Cancer Letter, Feb. 12.)
An effort is underway to restructure FDA based primarily on therapeutic areas, de-emphasizing the silos of drugs, biologics and devices. This would be done through the creation of FDA Centers of Excellence, which advocates say would improve coordination between FDA medical product centers.
At a recent Capitol Hill briefing, panel members—representing industry, FDA, academic oncology and patient advocacy—agreed that the time has come to reassess the way medical products are regulated at FDA (The Cancer Letter, Feb. 26).
“First of all, there’s nothing wrong, and FDA is doing a great job with what they have,” said Ellen Sigal, chair and founder of Friends of Cancer Research, the advocacy group that convened a panel discussion to explore a way forward for the regulatory agency.
“People at Center for Devices and Radiological Health, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are all doing a great job. But, the question is, can it be better?” said Sigal at the Feb. 24 event. “Patients get diseases, they don’t get a biologic; they don’t get a device. It all works together. Is there a more efficient way that is better? Because the goal is to get patients better treatments. This is what it’s about.
“It isn’t about institutional structures; it’s not about anyone doing a bad job. Is there an efficient, better way to serve the patient towards the goal of really integrating these centers of people in their particular fields working together?”
The text of Fitzpatrick’s April 14 letter to the vice president follows:
Dear Vice President Biden,
I applaud your efforts as part of the cancer Moonshot program to make cancer a thing of the past. This program will have life-changing effects on the more than 14 million people living with cancer in the United States.
As part of the Cancer Moonshot, President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration (FDA). The purpose of the center is to “support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.”
While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.
Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.
Power morcellators are FDA-cleared medical devices that are used to remove uterine fibroids. The blades of this device shred the uterine fibroids, which are then removed through a laparoscopic incision. For over two decades, morcellation was marketed as a safe, routine procedure. However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer throughout a woman’s body. This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. And tragically for too many women, this routine procedure ended with a death sentence.
Although the risk of spreading unsuspected cancers in women is as high as 1 in 352 cases, for decades the device stayed on the market, and it was only in November 2014 that the FDA put a black box warning on the device. It took a victim of morcellation and mother of 6, Dr. Amy Reed, to get the FDA take notice. It took the families of those who lost mothers, sisters, and wives, and those who continue to battle the cancer spread by morcellation, to get the FDA to take action.
As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics. While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm.
Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others. We must take action.
There are simple steps we can take today to improve patient safety for tomorrow’s beneficiaries of innovative new devices. One simple way we can do this is to ensure that serious injuries and deaths caused by medical devices are promptly reported to the FDA. For years there was evidence that morcellation was spreading cancer in women. But those reports never made it to the FDA. For years women were dying from the cancer spread by this device. But their deaths were never reported to the FDA by the hospitals, the device manufacturers, or the doctors who were charged with their care.
This was despite federal requirements that FDA be informed about unsafe devices. We must do more to strengthen medical device reporting regulations to ensure that dangerous devices, like the morcellator that spread cancer in women for decades, are quickly identified and removed from the market before they can do more harm.
I applaud your leadership on this important mission that will undoubtedly save lives, and look forward to continuing to work with you to help eliminate cancer as we know it.
Please do not hesitate to contact me if I may be of assistance.
Member of Congress