Power morcellation ban unlikely, but other FDA restrictions coming soon
The doc spearheading the antimorcellation campaign says FDA is divided, as are gynecologists
Showing posts with label harm to patients. Show all posts
Showing posts with label harm to patients. Show all posts
Sunday, November 9, 2014
Power morcellation ban unlikely, but other FDA restrictions coming soon
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| Johnson & Johnson's Ethicon division's power morcellation device, which has been recalled since the controversy errupted--Courtesy of Johnson & Johnson |
Cardiac surgeon Hooman Noorchashm and wife, Amy Reed, an anesthesiologist, have led the charge against the controversial surgical technique performed using the drill-like power morcellator. Power morcellation can upstage preexisting uterine cancers like uterine sarcoma to fatal levels.
Noorchashm and Reed have sparked public outcry, an FDA safety notice and a recall of power morcellators by former market leader Johnson & Johnson ($JNJ) via efforts like a petition on Change.org. Now they are aiming to take the campaign to its logical conclusion by securing an FDA ban of the device. That does not appear likely, according to information Noorchashm has received from a source within the FDA, who he wouldn't name during an interview.
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"The imminent plan that the CDRH has is to sugarcoat this thing using a probationary mechanism. That would deflect any sort of criticism away from 510(k). It would deflect public criticism of anyone who says FDA didn't do anything. CDRH can comes out and says, 'Well we did something. We put out an FDA advisory and we put the device under probation.' That basically will give industry a chance to recover from an absolute medical atrocity," he said.
It is unclear what a probation would entail. During the FDA's public hearing on power morcellation, the agency discussed solutions such as enhanced informed consent requirements, the use of a surgical bag during morcellation and the need for improved testing of uterine sarcoma prior to surgery. A ban of power morcellators was also on the table, although agency officials didn't seem too intent on that option.
Central to the debate is the prevalence ratio of uterine sarcoma prior to power morcellation. The FDA estimates that the ratio is one women in 350.
A well-publicized paper in the Journal of the American Medical Association estimated that the rate of uterine cancer in women who underwent morcellation was one in 370. However, uterine sarcoma is a rare subset of uterine cancer that is more difficult to detect prior to surgery than other cancers of the uterus. Uterine sarcoma specifically is the main cause of concern among the FDA and other public health experts.
The paper's author, Dr. Jason Wright of the Columbia University College of Physicians and Surgeons, said in an email to FierceMedicalDevices that he is unable to separate sarcomas or other subtypes of uterine cancer based on the insurance database. But he added, "I would assume that most cancers (in the sample) were not known preoperatively in women who underwent morcellation."
"Physicians who are defending this are saying the incidence (of uterine sarcoma in women undergoing morcellation) is one in 7,500," Noorchashm said, referring to research by obstetrician-gynecologist Elizabeth Pritts of the Wisconsin Fertility Institute.
Pritts spoke at the FDA public hearing and believes the agency is wildly overestimating the prevalence of uterine sarcoma because the agency used confirmation bias in its literature review used to arrive at its estimate of one in 350 women.
To add to the complexity, most experts assume that power morcellation poses a great chance of upstaging preexisting uterine sarcoma to fatal levels because it shreds and spreads the cancerous tissue to new parts of the body. However, in October Pritts and medical colleagues published a paper in the Journal of Minimally Invasive Gynecology concluding "there is no reliable evidence that morcellation (power or otherwise) significantly results in tumor upstaging."
"The new data by Dr. Pritts et al reveal that there is no proof that uterine morcellation upstages cancer. This is a critical discovery and changes the framework for discussion of how to care for the 31 million women with symptomatic fibroids," said gynecologic surgeon Antonio Pizarro in Shreveport, LA in an email. "Dr. Wright has issued a report of lapses in preoperative diagnosis for women with detectable cancers, not a report on sarcoma on women with fibroids."
Other members of the field favor strict action against power morcellators. "What you do about it is: you stop," said Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center in a prior article in The Wall Street Journal, adding "it's not worth playing Russian roulette with the patient."
So far the FDA has only banned one device. In 1983 it outlawed prosthetic hair fibers.
"The FDA is considering a great deal of information, including the panel's input, all comments from the public docket, and all relevant available data, in determining any future regulatory action. If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register," said an FDA spokeswoman in an email to FierceMedicalDevices.
Meanwhile, the Democrat & Chronicle reports that a third Rochester, NY, woman has recently died of an undetected cancer two years after undergoing power morcellation.
- here is the email
- here's the article in the Democrat & Chronicle
- here's Dr. Pritt's paper abstract
Related Articles:
Physicians defend power morcellator devices amid industry fallout
Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash
Upcoming study to dispute FDA's data on power morcellation risk
FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further
Power morcellator fallout continues after FDA advisory warning
Thursday, April 24, 2014
Finally, a Kaiser doctor, oncologist Jennifer Lycette, speaks out about doctors forced to allow harm to patients to increase profits
"...Lycette’s suit states, however, that she became troubled by new Kaiser policies
after [executive Jeffrey] Weisz was brought in.
"Among her other complaints, her suit alleges she expressed concerns about a ban on referring patients to non-Kaiser specialists or clinical trials outside of Kaiser -- even though doing so would be in the best interests of patients.
"She resigned in April 2013, because of her oath to do no harm and her belief that Kaiser policies were "making patients suffer," her suit states.
"According to the website for Oregon Health & Science University, Lycette relocated to Astoria and is now working at OHSU's Cancer Care Center at Columbia Memorial Hospital..."
Former oncologist claims Kaiser Permanente pushed profits over patient care, files $7 million lawsuit
Aimee Green
Oregon Live
April 23, 2014
A former oncologist at Kaiser Permanente is suing the health care company for $7 million, claiming she had no choice but to quit her job after complaining the organization was maximizing profits to the detriment of cancer patients.
Dr. Jennifer Lycette claims quality of care took a nosedive when Northwest Permanente Medical Group hired Jeffrey Weisz as its president and executive medical director in 2011. Weisz had previously worked for Kaiser in Southern California.
"During Dr. Weisz's tenure (in California), he established a reputation as a ruthless administrator who found ways to minimize payrolls by shrinking staff while patient loads skyrocketed, often leaving the remaining staff members trying to cope with impossible patient demands which ultimately harmed Kaiser's patients," reads Lycette's lawsuit, filed Tuesday in Multnomah County Circuit Court.
In an email statement, Kaiser spokesman Michael Foley said, "The care needs of our members, patients, and customers come first. Allegations that claim otherwise are not supported by fact.
"We're reviewing the lawsuit that was filed," he addied, "and will address its inaccurate allegations through the judicial process."
The suit was filed by Lake Oswego attorney Roderick Boutin.
Lycette's suits claims that during a November 2012 meeting, Weisz ordered Kaiser's Portland oncologists to cram an initial consultation and bone-marrow biopsy of patients -- something that should take two to 2.5 hours and be done over two visits -- into one, 60-minute visit. Lycette’s suit states pain medication that must be taken orally takes 30 to 60 minutes to kick in, so a 60-minute visit would leave patients rushed and in pain.
Lycette "openly and respectfully voiced her concerns," and Weisz responded by shouting at Lycette in "a very angry and threatening manner," her suit states.
Lycette's suit also claims she complained in April 2012 to the then-chief of medical oncology, Nagendra Tirumali, about understaffing. She says patients were struggling to schedule appointments and some chemotherapy patients were only seeing their regular oncologist every two or three months.
Tirumali responded that Lycette was being “emotional,” according to a copy of an email attached to the suit. Lycette’s suit characterizes Tirumali's response as a "veiled attack" on her gender. Her suit states she later asked Tirumali whether he would have accused a man of being "emotional" over the issue of understaffing.
Lycette, 40, worked for Kaiser for about seven years -- from 2006 until she resigned in spring 2013 -- at its Interstate medical offices in North Portland and Sunnyside Medical Center in Clackamas, according to her suit. Her suit states she had the highest patient satisfaction rating, 89 percent, in her department.
Lycette’s suit alleges that before taking the job in 2006, she asked several Kaiser doctors if they thought they could care for patients without feeling that financial overhead compromised care. They assured her they could, the suit states.
Lycette’s suit states, however, that she became troubled by new Kaiser policies after Weisz was brought in.
Among her other complaints, her suit alleges she expressed concerns about a ban on referring patients to non-Kaiser specialists or clinical trials outside of Kaiser -- even though doing so would be in the best interests of patients.
She resigned in April 2013, because of her oath to do no harm and her belief that Kaiser policies were "making patients suffer," her suit states.
According to the website for Oregon Health & Science University, Lycette relocated to Astoria and is now working at OHSU's Cancer Care Center at Columbia Memorial Hospital.
Lycette is seeking $2 million in economic damages and $5 million in non-economic damages.
"Among her other complaints, her suit alleges she expressed concerns about a ban on referring patients to non-Kaiser specialists or clinical trials outside of Kaiser -- even though doing so would be in the best interests of patients.
"She resigned in April 2013, because of her oath to do no harm and her belief that Kaiser policies were "making patients suffer," her suit states.
"According to the website for Oregon Health & Science University, Lycette relocated to Astoria and is now working at OHSU's Cancer Care Center at Columbia Memorial Hospital..."
Former oncologist claims Kaiser Permanente pushed profits over patient care, files $7 million lawsuit
Aimee Green
Oregon Live
April 23, 2014
A former oncologist at Kaiser Permanente is suing the health care company for $7 million, claiming she had no choice but to quit her job after complaining the organization was maximizing profits to the detriment of cancer patients.
Dr. Jennifer Lycette claims quality of care took a nosedive when Northwest Permanente Medical Group hired Jeffrey Weisz as its president and executive medical director in 2011. Weisz had previously worked for Kaiser in Southern California.
"During Dr. Weisz's tenure (in California), he established a reputation as a ruthless administrator who found ways to minimize payrolls by shrinking staff while patient loads skyrocketed, often leaving the remaining staff members trying to cope with impossible patient demands which ultimately harmed Kaiser's patients," reads Lycette's lawsuit, filed Tuesday in Multnomah County Circuit Court.
In an email statement, Kaiser spokesman Michael Foley said, "The care needs of our members, patients, and customers come first. Allegations that claim otherwise are not supported by fact.
"We're reviewing the lawsuit that was filed," he addied, "and will address its inaccurate allegations through the judicial process."
The suit was filed by Lake Oswego attorney Roderick Boutin.
Lycette's suits claims that during a November 2012 meeting, Weisz ordered Kaiser's Portland oncologists to cram an initial consultation and bone-marrow biopsy of patients -- something that should take two to 2.5 hours and be done over two visits -- into one, 60-minute visit. Lycette’s suit states pain medication that must be taken orally takes 30 to 60 minutes to kick in, so a 60-minute visit would leave patients rushed and in pain.
Lycette "openly and respectfully voiced her concerns," and Weisz responded by shouting at Lycette in "a very angry and threatening manner," her suit states.
Lycette's suit also claims she complained in April 2012 to the then-chief of medical oncology, Nagendra Tirumali, about understaffing. She says patients were struggling to schedule appointments and some chemotherapy patients were only seeing their regular oncologist every two or three months.
Tirumali responded that Lycette was being “emotional,” according to a copy of an email attached to the suit. Lycette’s suit characterizes Tirumali's response as a "veiled attack" on her gender. Her suit states she later asked Tirumali whether he would have accused a man of being "emotional" over the issue of understaffing.
Lycette, 40, worked for Kaiser for about seven years -- from 2006 until she resigned in spring 2013 -- at its Interstate medical offices in North Portland and Sunnyside Medical Center in Clackamas, according to her suit. Her suit states she had the highest patient satisfaction rating, 89 percent, in her department.
Lycette’s suit alleges that before taking the job in 2006, she asked several Kaiser doctors if they thought they could care for patients without feeling that financial overhead compromised care. They assured her they could, the suit states.
Lycette’s suit states, however, that she became troubled by new Kaiser policies after Weisz was brought in.
Among her other complaints, her suit alleges she expressed concerns about a ban on referring patients to non-Kaiser specialists or clinical trials outside of Kaiser -- even though doing so would be in the best interests of patients.
She resigned in April 2013, because of her oath to do no harm and her belief that Kaiser policies were "making patients suffer," her suit states.
According to the website for Oregon Health & Science University, Lycette relocated to Astoria and is now working at OHSU's Cancer Care Center at Columbia Memorial Hospital.
Lycette is seeking $2 million in economic damages and $5 million in non-economic damages.
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