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Morcellation Media Monitoring 4/22/2015
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The two ways AHIP says medical device regulation is inadequate
Apr 22, 2015 | Healthcare Dive
By Heather Caspi
The recent controversy over the use of laparoscopic power morcellators in the treatment of uterine fibroids, and the role of insurers in influencing those decisions, has taken another significant turn. America's Health Insurance Plans (AHIP) is calling for the insurance industry to impact the situation not only via influence on the medical community, but through efforts to improve the regulation of such devices. -
FDA’s Galloping Ineptitude
Apr 20, 2015 | Medical Device And Diagnostics Industry
By Jim Dickinson
Recent media coverage of adverse events related to morcellators and duodenoscopes exposes the incompetence of FDA's Center for Devices and Radiological Health. With growing frequency, it seems, mass media reporting on FDA’s handling of medical device postmarket safety issues portrays galloping ineptitude on the part of this international “gold standard” agency’s weakest component, the Center for Devices and Radiological Health (CDRH). -
United Health Changes Power Morcellator Coverage
Apr 20, 2015 | Top Class Actions
By Amanda Antell
United Health has changed its policy about how it will cover hysterectomies that use the controversial power morcellator. United Health says it will require prior authorization for all non-vaginal hysterectomies. And, the insurer says, it will not cover any non-vaginal hysterectomy procedures if they are not medically needed. -
WSJ Wins Pulitzer
Apr 20, 2015 | Nasdaq
The Journal, which is owned by News Corp, was a finalist in the public-service category for articles that showed a surgical tool used in hysterectomies, a morcellator, can spread cancer. The committee noted the series "prompted a change in the prescribed medical treatment." -
Morning Break: H5N2 on a Farm Near You; DMD Drug Passes Big Test
Apr 21, 2015 | MedPage Today
A probe of deaths from domestic abuse won the Charleston, S.C., Post and Courier a Pulitzer Prize in its prestigious Public Service category. The Wall Street Journal's reporting on power morcellation of uterine fibroids got an honorable mention in the category.
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Full Text of Stories Below
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The two ways AHIP says medical device regulation is inadequate
Apr 22, 2015 | Healthcare Dive
By Heather Caspi
The recent controversy over the use of laparoscopic power morcellators in the treatment of uterine fibroids, and the role of insurers in influencing those decisions, has taken another significant turn. America's Health Insurance Plans (AHIP) is calling for the insurance industry to impact the situation not only via influence on the medical community, but through efforts to improve the regulation of such devices.
In a letter sent last week to Sen. Robert P. Casey that AHIP has provided to Healthcare Dive, association President and CEO Karen Ignagni outlines what the group deems "serious gaps in the current approval and post monitoring process for medical devices" and suggests how specific regulatory changes could improve patient safety. Casey had contacted the group March 24 to gauge the industry's position on morcellators.
The issue has illustrated the growing reach of the health insurance industry. While insurers may still face uphill battles in influencing change outside their traditional sphere of influence, their voices are clearly carrying weight.
AHIP's letter indicates that chief medical officers in the industry are seeing a major reduction in the use of laparoscopic power morcellators, and credits insurers among those responsible. "The action of the FDA, the comments by ACOG, and the steps taken by health plans have contributed to the decline in use of power morcellators," states AHIP's letter.
AHIP criticizes the fact that most medical devices receive FDA approval through the 510(k) process.
AHIP is now criticizing the fact that most medical devices regulated by the FDA receive their market approval through the 510(k) process, in which the manufacturer only needs to demonstrate that their device is "substantially equivalent" to another one already approved and on the market. The manufacturer does not have to assess its specific medical device for safety and effectiveness.
"As Congress continues to explore ways to promote biomedical innovation, we urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators," AHIP writes. They add that requiring post-marketing review will aid insurers' ability to identify adverse events and react quickly to other emerging safety issues.
Along with these efforts, AHIP is urging the acceleration of the unique device identification (UDI) system, which was signed into law with the Food and Drug Administration Amendments Act of 2007 but has not been given a timeline. AHIP notes that UDI integration into clinical data sources including EHRs is a key part of the goal toward a national medical device surveillance system, which it says numerous member health plans participated in developing. "Expanding UDI use would also complement the FDA's Safety Sentinel project in which our member plans have been integrally involved," the letter states.
Steve Ubl of the Advanced Medical Technology Association calls the 510(k) system "overwhelmingly safe."
auto image + linkAHIP's position is not without opposition. While the 510(k) system has been criticized by other groups, including a 2011 Institute of Medicine panel, others are defending it in the medical-device industry and the FDA.
Steve Ubl of the Advanced Medical Technology Association responded to AHIP's letter with comments in the Wall Street Journal, in which he calls the 510(k) system "overwhelmingly safe."
"FDA's 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements," he told the Journal.
The FDA declined to comment on the letter.
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Apr 20, 2015 | Medical Device And Diagnostics Industry
By Jim Dickinson
Recent media coverage of adverse events related to morcellators and duodenoscopes exposes the incompetence of FDA's Center for Devices and Radiological Health. With growing frequency, it seems, mass media reporting on FDA’s handling of medical device postmarket safety issues portrays galloping ineptitude on the part of this international “gold standard” agency’s weakest component, the Center for Devices and Radiological Health (CDRH).
We had just absorbed the news of the 510(k)-damning laparoscopic power morcellator’s postmarket capacity to spread cancer throughout the bodies of one in 350 women undergoing hysterectomies with morcellation. Almost immediately after this news, we were confronted with outbreaks of even more lethal bacterial infections from incompletely sterilized duodenoscopes.
Besides their common FDA 510(k) status—something that tells nothing about their safety, since proof of that is not required for 510(k) clearance—the most noticeable characteristic these devices had in common was lax oversight in the marketplace by CDRH.
As recounted here in an earlier column and in The Wall Street Journal, CDRH uncritically cleared power morcellators for two decades and did not question their safety until The Wall Street Journal ran an exposé article in 2013. It took another year and another WSJ exposé plus heroic efforts by a victim and her husband to move the agency to warn against the morcellators’ use.
The duodenoscopes episode followed a similar course, but without the muscle of The Wall Street Journal it took much longer to unfold. It was the skinnier and more ubiquitous USA Today that picked up on the duodenoscopes story in February and ran with it, repeatedly. The initial report came from Ronald Reagan UCLA Medical Center on February 19 and to its credit, FDA issued a public alert that day about upgraded cleaning procedures for these devices.
However, that turned out to be a lucky break. The underlying problem at CDRH was much deeper than one hospital’s diligence in contacting FDA.
In April, USA Today reported that although medical device makers are required to file reports to FDA within 30 days of learning that a product may pose safety risks, and although duodenoscopes had been linked to the “transmission of drug-resistant bacteria among patients in at least eight U.S. hospitals from 2012-2014, the agency wasn’t notified of some outbreaks until long after they occurred…And in some cases, the disclosures never were filed.”
Moreover, the newspaper’s review of CDRH’s public database for MDRs on duodenoscope-related infections could not find enough reports—only 75—to account for all the outbreaks of multidrug-resistant bacterial infections caused by carbapenem-resistant enterobacteriaceae (CRE) that had been linked to duodenoscopes.
Worse, FDA had redacted identifying information from the MDRs, making it impossible for USA Today to determine which outbreaks and manufacturers were missing from reports.
At least six of the hospitals where outbreaks occurred used duodenoscopes made by Olympus Corporation of the Americas, according to information obtained by the newspaper. The company declined to comment to USA Today, citing pending lawsuits filed by patients claiming harm from infections.
Olympus filed an MDR with FDA about an infection outbreak at Seattle’s Virginia Mason Hospital last August, USA Todayreported, but this was well after company officials went to the hospital the previous November to investigate CRE infections there.
According to USA Today, the initial Olympus MDR said the hospital told the company in 2013 about “alleged infections” in patients treated with its duodenoscopes but did not say that company representatives had gone to the hospital and reviewed evidence that the devices were transmitting infections. The MDR also said the company never had a chance to examine the devices and that Virginia Mason personnel “declined” an Olympus offer to have its staff assess the hospital’s reprocessing operation.
In fact, the newspaper account said, company officials had access to the devices and sent them to Olympus for more detailed examination. The company representatives also reportedly observed the reprocessing activity at the hospital and validated that the work was free of errors that could explain the bacteria found on the scopes.
USA Today’s report called the MDR reporting problems it found “an Achilles’ heel in FDA’s oversight of medical devices: the responsibility for identifying potential safety problems falls primarily on manufacturers themselves. And if a flaw in a medical implant, a surgical instrument, or some other device goes unreported, the product can remain in use for months or years, raising profound public health risks.”
About half a million duodenoscope procedures are performed annually in the U.S. and the lion’s share of the duodenoscope market is owned by Olympus with its TJF-Q180V device, which although categorized by CDRH as a 510(k), had no 510(k) clearance at the time of the CRE outbreak.
As an FDA Web posting on this anomalous situation explained, to remove Olympus’ duodenoscope from the market pending 510(k) clearance “could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.”
Not a word about how the device could have captured the lion’s share of the market without having gone through the 510(k) clearance process.
A voice mail message left for Mark Miller, Olympus vice president for communications and marketing services, brought no response.
Freshman congressman Ted Lieu (D–CA) sent a letter on March 23 that, almost a month later, had elicited little more than an acknowledgment saying Olympus was working on a response. Among other things, Lieu wanted to know why Olympus had not sought FDA approval for its duodenoscope redesign in 2010, when it first learned of the device causing CRE infections, and whether it plans to “recall the current duodenoscope and replace it with one that can be cleaned reliably?”
At time of this writing, FDA’s newest Web posting on the matter appears to be amply satisfied with Olympus’ upgraded and validated cleaning instructions, and Olympus’ own communications with its customers seems similarly satisfied with FDA’s position.
These are but two current examples of CDRH ineptitude. In recent months, I have dealt with others here, some that go back into the 1990s.
Take the issue of MDRs. In a 2009 HHS Office of the Inspector General audit, investigators found that while the Center has been receiving many more MDRs annually, very few are reviewed by analysts within 30 days and less than half within 60 days.
The OIG said then that FDA has no way to know when or how often manufacturers fail to file MDRs and the agency “rarely” takes action when reports are late. In a statement to USA Today, FDA said it does “routine surveillance” to ensure that device manufacturers file MDRs when their products are tied to possible safety risks.
That’s a far cry from daily CDRH monitoring of received MDRs for that regulation’s original purpose: CDRH’s early discovery and efficient regulatory action on medical device safety problems.
Section 510(k) of the Federal Food, Drug Cosmetic Act, which provides the statutory portal through which 98% of new devices enter the market contains no provision requiring proof of safety and effectiveness. That is left to CDRH to determine administratively under rulemaking.
And that, in turn, is the fulcrum for what USA Today’s exposé called the “Achilles heel” of device regulation: manufacturers self-police their own compliance under the distracted and overwhelmed watch of a regulatory Center that is, in human health product safety terms, FDA’s most inept.
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United Health Changes Power Morcellator Coverage
Apr 20, 2015 | Top Class Actions
By Amanda Antell
United Health has changed its policy about how it will cover hysterectomies that use the controversial power morcellator.
United Health says it will require prior authorization for all non-vaginal hysterectomies. And, the insurer says, it will not cover any non-vaginal hysterectomy procedures if they are not medically needed.
Many women who need to undergo a hysterectomy opt for non-vaginal surgical options like those that use power morcellator devices, because the procedure is minimally invasive and requires less hospital time.
The insurance company’s policy change follows a safety announcement by the U.S. Food and Drug Administration (FDA) in November noting the potential risk that powered morcellators carry of spreading uterine cancer. When the power morcellator cuts and removes the uterine fibroids, it can unintentionally rupture a uterine sarcoma that releases cancer cells throughout the body.
While not all women carry uterine sarcomas, it is impossible to determine if the patient carries uterine sarcoma before the surgery.
Overview of Power Morcellator Complications
A uterine hysterectomy procedure is when the patient undergoes a removal procedure of the uterus. There are a number of reasons why women undergo these procedures including uterine fibroid removal, endometriosis, uterine prolapse, pelvic pain, abnormal uterine bleeding, and uterine cancer.
In going through this surgery, many women often opt for power morcellator to be used during the procedure because of the need for only a small incision to be made.
Power morcellators have tiny rotating blades attached to them, which break down the uterine fibroids into small fragments that are then, vacuumed out of the body. The incision made during these procedures is less than two centimeters in size. Due to the smaller entry points, women do not have to recover from large incisions that are normally made in hysterectomy procedures, resulting in short hospital recovery time.
Doctors perform approximately 600,000 hysterectomies a year in the United States. An estimated 11 to 12 percent of these use a power morcellator.
Despite concerns surrounding power morcellators, the FDA has decided not to pull these devices from the market. Instead, the FDA now requires physicians to inform women of the risks of uterine cancer and that uterine sarcoma cannot be diagnosed before the procedure.
However, these warnings may have come too late to many women who underwent uterine fibroid surgery and then were diagnosed with uterine cancer. Many of the women complained that they were not given sufficient safety information before their procedures, and that they never would have used the device if they knew of the risks of uterine cancer.
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Apr 20, 2015 | Nasdaq
The Wall Street Journal won a Pulitzer Prize, journalism's highest honor, for a series of articles exposing abuses in the Medicare system.
The New York Times won three Pulitzer Prizes, the most of any news organization, including awards for investigative reporting, international reporting and feature photography. Bloomberg News won its first Pulitzer ever, for explanatory reporting, while the Los Angeles Times won in the feature writing and criticism categories.
In the investigative category, Wall Street Journal staff won for the paper's "Medicare Unmasked" series that provided Americans "unprecedented access to previously confidential data on the motivations and practices of their health care providers." The Journal's stories came after a prolonged legal fight that led the government to release the data.
"This was an important piece of work that has shed light on information Washington wanted to keep hidden from Americans about how this vast government program is distorted by fraud and waste," said Gerard Baker, editor in chief of The Wall Street Journal, in a note to the paper's staff. "Our reporting has sparked congressional inquiries and criminal charges and changed public attitudes towards Medicare."
The coverage was led by Michael Siconolfi, investigations editor, and health-care bureau chief Stefanie Ilgenfritz. Mr. Siconolfi said the series was a group effort and said seven reporters whose work stood out on it included John Carreyrou, Christopher Weaver, Christopher Stewart, Tom McGinty, Rob Barry, Anna Mathews and Janet Adamy.
He also cited the Journal's graphics team: Martin Burch, Chris Canipe, Madeline Farbman, Jon Keegan, Palani Kumanan and Stuart Thompson.
The Journal, which is owned by News Corp, was a finalist in the public-service category for articles that showed a surgical tool used in hysterectomies, a morcellator, can spread cancer. The committee noted the series "prompted a change in the prescribed medical treatment."
Also nominated as finalist for The Wall Street Journal, in the commentary category, was Matthew Kaminski for columns from Ukraine. Mr. Kaminski has since left the newspaper.
The New York Times won in the investigative category for a series by Eric Lipton on the influence of lobbyists. The Times also won for its "front-line reporting and vivid human stories" on Ebola in the international reporting category.
In comments to the newsroom at the New York Times, Dean Baquet, executive editor, said, "Amid the debate about the future of journalism, you kept your eye on our values, with judgment, big stories, and vivid storytelling." Mr. Baquet also noted that the paper had eight finalists in addition to its three Pulitzers.
Bloomberg News won for reporting by Zachary R. Mider, who the Pulitzer committee cited for his "painstaking, clear and entertaining explanation of how so many U.S. corporations dodge taxes and why lawmakers and regulators have a hard time stopping them."
For breaking-news reporting, the Seattle Times was recognized for its coverage of a landslide that killed 43 people and whether the disaster could have been avoided.
For the 99th annual competition, the Post and Courier, of Charleston, S.C., won in the public-service category for its series "Till Death Do Us Part." The articles examined why the state is among the deadliest in the union for women and " put the issue of what to do about it on the state's agenda," according to Columbia University, which oversees the prizes.
On the literary front, Anthony Doerr's moving tale of World War II, "All the Light We Cannot See," won in the fiction category.
The full list of winners:
JOURNALISM
Public service:the Post and Courier, Charleston, S.C.
Breaking news reporting: the Seattle Times staff
Investigative reporting (two prizes): Eric Lipton of the New York Times and The Wall Street Journal staff
Explanatory reporting: Zachary R. Mider of Bloomberg News
Local reporting: Rob Kuznia, Rebecca Kimitch and Frank Suraci of the Daily Breeze, Torrance, Calif.
National reporting: Carol D. Leonnig of the Washington Post
International reporting: the New York Times staff
Feature writing: Diana Marcum of the Los Angeles Times
Commentary: Lisa Falkenberg of the Houston Chronicle
Criticism: Mary McNamara of the Los Angeles Times
Editorial writing: Kathleen Kingsbury of the Boston Globe
Editorial cartooning: Adam Zyglis of the Buffalo News
Breaking news photography: St. Louis Post-Dispatch photography staff
Feature photography: Daniel Berehulak, freelance photographer, the New York Times
BOOKS, DRAMA AND MUSIC
Fiction: "All the Light We Cannot See" by Anthony Doerr (Scribner)
Drama: "Between Riverside and Crazy" by Stephen Adly Guirgis
History: "Encounters at the Heart of the World: A History of the Mandan People" by Elizabeth A. Fenn (Hill and Wang)
Biography: "The Pope and Mussolini: The Secret History of Pius XI and the Rise of Fascism in Europe" by David I. Kertzer (Random House)
Poetry: "Digest" by Gregory Pardlo (Four Way Books)
General nonfiction: "The Sixth Extinction: An Unnatural History" by Elizabeth Kolbert (Henry Holt)
Music: "Anthracite Fields" by Julia Wolfe (G. Schirmer Inc.)
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Morning Break: H5N2 on a Farm Near You; DMD Drug Passes Big Test
Apr 21, 2015 | MedPage Today
H5N2 avian flu reared its head at a giant Iowa farm, where more than 5 million chickens face slaughter. And Wisconsin declared a state of emergency because of an H5N2 outbreak there.
A drug preserved respiratory function in patients with Duchenne muscular dystrophy in a late-stage trial, its manufacturer said.
Teva agreed to pay more than $500 million to settle charges that its Cephalon unit unfairly tried to keep generic versions of its stay-awake drug Provigil off the market.
This is your body after 26.2 miles of running. Any questions?
David Gorski has an update on hockey legend Gordie Howe's stem-cell therapy for stroke.
Here's the latest direct-to-consumer genetic test to frighten your patients.
Wall Street types are reportedly into a "nootropic" brain-boost pill that tries to duplicate the effects of drugs like modafinil with over-the-counter supplement ingredients. (New York Observer)
And this OTC beverage containing N-acetylcysteine supposedly prevents hangovers. (Fortune)
A probe of deaths from domestic abuse won the Charleston, S.C., Post and Courier a Pulitzer Prize in its prestigious Public Service category. The Wall Street Journal's reporting on power morcellation of uterine fibroids got an honorable mention in the category.
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