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 medical devices. Show all posts
Showing posts with label medical devices. 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
Saturday, August 30, 2014
Many Women Have Died Unnecessarily Because of surgery with MORCELLATORS
Why does Morcellation surgery continue when we know it kills women? Why do doctors continue to do the surgery? The answer: profits for medical device companies, profits for doctors.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
Dr. Noorchashm asks: "When new technology makes
medicine cheaper and more convenient, how many
patients have to die to prove it's not worth it?"
Petition by Hooman Noorchashm, MD, PhD:
My wife [Dr. Amy Reed] had a surgical procedure that spread cancerous cells throughout her body. She now has stage 4 cancer. Please sign my petition demanding the FDA stop a procedure that has spread cancer in thousands of women.
My wife Amy is a mother of six, and an accomplished anesthesiologist who helped treat victims of the Boston Marathon bombing last year.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
Dr. Noorchashm asks: "When new technology makes
medicine cheaper and more convenient, how many
patients have to die to prove it's not worth it?"
Petition by Hooman Noorchashm, MD, PhD:
My wife [Dr. Amy Reed] had a surgical procedure that spread cancerous cells throughout her body. She now has stage 4 cancer. Please sign my petition demanding the FDA stop a procedure that has spread cancer in thousands of women.
My wife Amy is a mother of six, and an accomplished anesthesiologist who helped treat victims of the Boston Marathon bombing last year.
Now, because of a dangerous, but standard, gynecological
procedure her early stage cancer was spread -- causing stage 4 cancer.
Last Fall, Amy went in for a routine hysterectomy to treat what
we thought were benign fibroids, and had a minimally invasive “morcellation”
procedure to remove her uterus. Little did we know that this procedure would
end up spreading malignant cancer cells throughout Amy’s belly. What's more is
that “morcellation” is totally avoidable and it has devastated thousands of
women and families by spreading and upstaging dangerous cancers of the uterus
and ovaries.
Now we’re taking a stand in hopes of banning this surgery for
good, and saving the lives of countless women and mothers. And the momentum is
on our side.
Because of the momentum of this petition,
numerous hospitals around the country have stopped performing this type of
hysterectomy. Last week, a major health insurer -- Blue Cross Blue Shield --
announced that they would no longer cover the procedure. And Johnson &
Johnson, which manufactures some of the surgical tools used in this procedure,
issued a worldwide voluntary recall of the tools called "power
morcellators," saying that they couldn’t guarantee that the procedure was
safe for women to undergo.
The reason this surgical procedure is so controversial is that doctors
have no reliable way of testing whether patients are at risk of having
cancerous cells spread throughout their body during the surgery. That was
the case with Amy -- in the process of removing her uterus, undetected cancer
cells were spread throughout her abdomen region, and stage 4 cancer developed.
The same has happened to scores of other women, globally. Women who went in
thinking they were having a “minimally invasive” procedure, left the operating
room with an advanced stage of cancer.
Last month, the FDA held public hearings on this surgical
procedure. Amy and I traveled down to Washington, D.C., to talk about this
petition and to bring Amy’s story to the attention of FDA and congressional
regulators. They are currently debating whether to ban this procedure or not,
and that’s why I need your help today.
I cannot tell you what this means to my wife, to me, and to our
family. Together, we can help potentially save the lives of thousands of women
moving forward. No other woman should ever have her uterine cancer upstaged to
an advanced stage by a gynecologist practicing this totally avoidable procedure
they call "morcellation."
Thank you,
Hooman Noorchashm, MD, PhD
Boston, MA
Boston, MA
Health Alert: Many Women Have Died Unnecessarily Because Dangerous Cancers of the Uterus and Ovaries Are Being Spread using MORCELLATORS. Stop MORCELLATION in Minimally Invasive Gynecological Surgery.
Friends of the Public,
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
Tuesday, June 10, 2014
Consumer group questions online medical device ads
Consumer group questions online medical device ads
WASHINGTON
—
A consumer watchdog group on Wednesday questioned the legality of
several advertisements for medical devices that appear on YouTube and
called on regulators to crack down on the promotions.
Online videos from Abbott Laboratories, Medtronic Inc. and Stryker
Corp. tout the benefits of their devices, but do not mention the risks,
according to the Boston-based nonprofit group, Prescription Project.
The Food and Drug Administration requires television advertisements for
drugs and medical devices to give a balanced picture of benefits and
risks; however, it's unclear whether that law also applies to Internet
promotions, the group says.
"The videos raise serious questions about whether drug and device
companies are using the Internet to skirt laws that safeguard
consumers," said Allan Coukell, director of policy for the Prescription
Project.
In a petition submitted to the FDA, the group asks regulators to order
the companies to remove the advertisements from the Web. The group also
asks the agency to issue regulations specifying that online ads are
subject to the same standards as television ads.
Among the ads cited in the petition are an advertisement for Medtronic's artificial spine disk, Prestige.
Wednesday, April 23, 2014
UCLA pays $10 million for retaliation against surgeon who exposed industry payments that may have compromised patient care
This case is just a small part of a larger problem at UCLA. Another small part of the problem, the behavior of Eugene Washington, dean of the David Geffen Medical School at UCLA, is discussed HERE.
UCLA'S $10 MILLION WHISTLE-BLOWER RETALIATION CASE:
UCLA surgeon Dr. Robert Pedowitz, who said the medical school allowed doctors to take industry payments that may have compromised patient care
UC OKs paying surgeon $10 million in whistleblower-retaliation case
The settlement ends a case brought by the ex-head of UCLA's orthopedic surgery department
By Chad Terhune
Los Angeles Times
April 22, 2014
University of California regents agreed to pay $10 million to the former chairman of UCLA's orthopedic surgery department, who had alleged that the well-known medical school allowed doctors to take industry payments that may have compromised patient care.
The settlement reached Tuesday in Los Angeles County Superior Court came just before closing arguments were due to begin in a whistleblower-retaliation case brought by Dr. Robert Pedowitz, 54, a surgeon who was recruited to UCLA in 2009 to run the orthopedic surgery department.
In 2012, the surgeon sued UCLA, the UC regents, fellow surgeons and senior university officials, alleging they failed to act on his complaints about widespread conflicts of interest and later retaliated against him for speaking up.
UCLA denied Pedowitz's allegations, and officials said they found no wrongdoing by faculty and no evidence that patient care was jeopardized. But the UC system paid him anyway, saying it wanted to avoid the "substantial expense and inconvenience" of further litigation.
[Maura Larkins: Closing arguments were about to begin in the case. UCLA had already invested "substantial expense and inconvenience", and would have incurred very little expense or inconvenience if it had simply allowed the closing arguments to go forward. The reason it settled was that it realized that the weight of the evidence showed that UCLA did indeed jeopardize patient safety and certainly violated conflict of interest standards and the legal rights of the whistle-blower.]
As department chairman, Pedowitz testified, he became concerned about colleagues who had financial ties to medical-device makers or other companies that could unduly influence their care of patients or taint important medical research.
He also alleged that UCLA looked the other way because the university stood to benefit financially from the success of medical products or drugs developed by its doctors.
One of the orthopedic surgeons that Pedowitz complained about testified at trial about receiving $250,000 in consulting fees in 2008 from device maker Medtronic. In memos to university officials, Pedowitz raised concerns about the financial dealings of other doctors as well.
Inside the courtroom Tuesday, Pedowitz sat in the front row with his wife and daughter as the judge told jurors that a settlement had been reached. He said he felt vindicated by the outcome.
"These are serious issues that patients should be worried about," Pedowitz said in an interview. "These problems exist in the broader medical system and they are not restricted to UCLA."
The seven-week trial in downtown Los Angeles offered a rare glimpse into those potential conflicts at a time when there is growing government scrutiny of industry payments to doctors.
Starting this fall, the federal Physician Payments Sunshine Act, part of President Obama's healthcare law, requires public disclosure of financial relationships between healthcare companies and physicians.
Many doctors and universities defend long-standing industry arrangements as essential for carrying out cutting-edge research and top-flight medical education.
In a statement Tuesday, the UC regents said they "resolved this lawsuit to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement."
The statement added that "multiple investigations by university officials and independent investigators concluded that conduct by faculty members was lawful. Patient care was not compromised."
This latest settlement eclipses a $4.5-million payout the UC regents made last year to resolve a racial discrimination lawsuit filed by another UCLA surgeon.
Pedowitz, as part of his settlement, left the UCLA faculty, effective Tuesday. He had agreed to step down as department chairman in 2010 after initially voicing his concerns to top UCLA officials. He filed a whistleblower retaliation complaint in March 2011.
Experts in medical ethics say the UCLA case shows much more needs to be done within academia and by government regulators to address potential conflicts of interest in medicine.
Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools are still reluctant to take on specialists who bring in considerable money from patients, medical research and patents on breakthrough products.
"Institutions can be dependent on the money these big-earning specialties like orthopedic surgery bring in," Chimonas said. "They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."
In an interview last week, the chief compliance officer at the UCLA Health System flatly rejected the notion that the university didn't enforce its policies or look fully into Pedowitz's allegations. She also said industry ties are unavoidable at a big medical school and rules are in place to prevent conflicts.
"We have processes in place to identify those relationships in a transparent fashion and ensure they don't have any inappropriate influence on the actions of the university," said Marti Arvin, chief compliance officer. "In order to meet our mission, it is important we have both the brilliant minds we have at UCLA and collaboration with industry."
Arvin said the university "thoroughly and objectively investigated those allegations of noncompliance raised by Dr. Pedowitz. We were able to determine the vast majority were unsubstantiated."
She said two doctors fell short of university expectations in their handling of outside income, but there was no violation of law or university policy in either instance.
Arvin cited the case of Dr. Nick Shamie, the orthopedic surgeon who testified at trial about receiving $250,000 from Medtronic for consulting work. She said department policy at the time didn't require Shamie to send that outside income through UCLA's faculty compensation plan.
At trial, Pedowitz said he was deeply troubled by the large amount of money Shamie was paid. He testified that he was particularly concerned that Shamie was trying to enroll patients in a research study involving Medtronic at the time.
"I saw this as an obvious problem," Pedowitz testified.
In court, Shamie said he abided by university policy and didn't pursue the study further because finding patients was too difficult. He couldn't be reached for additional comment.
The other physician cited by Arvin for a potential shortcoming was Dr. David McAllister, vice chairman of clinical operations for the orthopedic surgery department.
He didn't report payments from the Musculoskeletal Transplant Foundation, a nonprofit tissue bank that does business with UCLA, because he didn't think disclosure was required in that instance because it didn't involve a for-profit entity, Arvin said.
McAllister also declined to comment, referring a call to UCLA.
Shortly before Pedowitz joined UCLA in 2009, the university was already facing criticism from Congress over the failure of a top spine surgeon to report nearly $460,000 in payments he received from Medtronic and other medical companies while researching their products' use in patients, government records show.
Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa) publicized his lapse in disclosure as part of a larger investigation into medical conflicts of interest.
Several patients are now suing Wang and UCLA in state court for negligence, fraud and malpractice in connection with surgeries involving Medtronic's controversial Infuse bone graft. UCLA said it doesn't comment on pending litigation. Wang couldn't be reached for comment.
Shortly after raising his concerns, Pedowitz said, he was pressured to step down as department chairman in 2010. Pedowitz said he was further retaliated against by being denied patient referrals and prevented from participating in grants and other activities.
Before UCLA, Pedowitz worked at UC San Diego and as chairman of orthopedics and sports medicine at the University of South Florida.
Mark Quigley, an attorney representing Pedowitz, said the case could have been avoided if the UC system enforced the policies it already has in place.
"What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" Quigley said. "The university wanted to cover it all up."
UCLA'S $10 MILLION WHISTLE-BLOWER RETALIATION CASE:
"Shortly before Pedowitz joined UCLA in 2009, the university was already facing criticism from Congress over the failure of a top spine surgeon to report nearly $460,000 in payments he received from Medtronic and other medical companies while researching their products' use in patients, government records show.
"Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa) publicized his lapse in disclosure as part of a larger investigation into medical conflicts of interest.
"Several patients are now suing Wang and UCLA in state court for negligence, fraud and malpractice in connection with surgeries involving Medtronic's controversial Infuse bone graft."
"...'What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?' Quigley said. 'The university wanted to cover it all up.'"
UCLA surgeon Dr. Robert Pedowitz, who said the medical school allowed doctors to take industry payments that may have compromised patient care
UC OKs paying surgeon $10 million in whistleblower-retaliation case
The settlement ends a case brought by the ex-head of UCLA's orthopedic surgery department
By Chad Terhune
Los Angeles Times
April 22, 2014
University of California regents agreed to pay $10 million to the former chairman of UCLA's orthopedic surgery department, who had alleged that the well-known medical school allowed doctors to take industry payments that may have compromised patient care.
The settlement reached Tuesday in Los Angeles County Superior Court came just before closing arguments were due to begin in a whistleblower-retaliation case brought by Dr. Robert Pedowitz, 54, a surgeon who was recruited to UCLA in 2009 to run the orthopedic surgery department.
In 2012, the surgeon sued UCLA, the UC regents, fellow surgeons and senior university officials, alleging they failed to act on his complaints about widespread conflicts of interest and later retaliated against him for speaking up.
UCLA denied Pedowitz's allegations, and officials said they found no wrongdoing by faculty and no evidence that patient care was jeopardized. But the UC system paid him anyway, saying it wanted to avoid the "substantial expense and inconvenience" of further litigation.
[Maura Larkins: Closing arguments were about to begin in the case. UCLA had already invested "substantial expense and inconvenience", and would have incurred very little expense or inconvenience if it had simply allowed the closing arguments to go forward. The reason it settled was that it realized that the weight of the evidence showed that UCLA did indeed jeopardize patient safety and certainly violated conflict of interest standards and the legal rights of the whistle-blower.]
As department chairman, Pedowitz testified, he became concerned about colleagues who had financial ties to medical-device makers or other companies that could unduly influence their care of patients or taint important medical research.
He also alleged that UCLA looked the other way because the university stood to benefit financially from the success of medical products or drugs developed by its doctors.
One of the orthopedic surgeons that Pedowitz complained about testified at trial about receiving $250,000 in consulting fees in 2008 from device maker Medtronic. In memos to university officials, Pedowitz raised concerns about the financial dealings of other doctors as well.
Inside the courtroom Tuesday, Pedowitz sat in the front row with his wife and daughter as the judge told jurors that a settlement had been reached. He said he felt vindicated by the outcome.
"These are serious issues that patients should be worried about," Pedowitz said in an interview. "These problems exist in the broader medical system and they are not restricted to UCLA."
The seven-week trial in downtown Los Angeles offered a rare glimpse into those potential conflicts at a time when there is growing government scrutiny of industry payments to doctors.
Starting this fall, the federal Physician Payments Sunshine Act, part of President Obama's healthcare law, requires public disclosure of financial relationships between healthcare companies and physicians.
Many doctors and universities defend long-standing industry arrangements as essential for carrying out cutting-edge research and top-flight medical education.
In a statement Tuesday, the UC regents said they "resolved this lawsuit to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement."
The statement added that "multiple investigations by university officials and independent investigators concluded that conduct by faculty members was lawful. Patient care was not compromised."
This latest settlement eclipses a $4.5-million payout the UC regents made last year to resolve a racial discrimination lawsuit filed by another UCLA surgeon.
Pedowitz, as part of his settlement, left the UCLA faculty, effective Tuesday. He had agreed to step down as department chairman in 2010 after initially voicing his concerns to top UCLA officials. He filed a whistleblower retaliation complaint in March 2011.
Experts in medical ethics say the UCLA case shows much more needs to be done within academia and by government regulators to address potential conflicts of interest in medicine.
Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools are still reluctant to take on specialists who bring in considerable money from patients, medical research and patents on breakthrough products.
"Institutions can be dependent on the money these big-earning specialties like orthopedic surgery bring in," Chimonas said. "They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."
In an interview last week, the chief compliance officer at the UCLA Health System flatly rejected the notion that the university didn't enforce its policies or look fully into Pedowitz's allegations. She also said industry ties are unavoidable at a big medical school and rules are in place to prevent conflicts.
"We have processes in place to identify those relationships in a transparent fashion and ensure they don't have any inappropriate influence on the actions of the university," said Marti Arvin, chief compliance officer. "In order to meet our mission, it is important we have both the brilliant minds we have at UCLA and collaboration with industry."
Arvin said the university "thoroughly and objectively investigated those allegations of noncompliance raised by Dr. Pedowitz. We were able to determine the vast majority were unsubstantiated."
She said two doctors fell short of university expectations in their handling of outside income, but there was no violation of law or university policy in either instance.
Arvin cited the case of Dr. Nick Shamie, the orthopedic surgeon who testified at trial about receiving $250,000 from Medtronic for consulting work. She said department policy at the time didn't require Shamie to send that outside income through UCLA's faculty compensation plan.
At trial, Pedowitz said he was deeply troubled by the large amount of money Shamie was paid. He testified that he was particularly concerned that Shamie was trying to enroll patients in a research study involving Medtronic at the time.
"I saw this as an obvious problem," Pedowitz testified.
In court, Shamie said he abided by university policy and didn't pursue the study further because finding patients was too difficult. He couldn't be reached for additional comment.
The other physician cited by Arvin for a potential shortcoming was Dr. David McAllister, vice chairman of clinical operations for the orthopedic surgery department.
He didn't report payments from the Musculoskeletal Transplant Foundation, a nonprofit tissue bank that does business with UCLA, because he didn't think disclosure was required in that instance because it didn't involve a for-profit entity, Arvin said.
McAllister also declined to comment, referring a call to UCLA.
Shortly before Pedowitz joined UCLA in 2009, the university was already facing criticism from Congress over the failure of a top spine surgeon to report nearly $460,000 in payments he received from Medtronic and other medical companies while researching their products' use in patients, government records show.
Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa) publicized his lapse in disclosure as part of a larger investigation into medical conflicts of interest.
Several patients are now suing Wang and UCLA in state court for negligence, fraud and malpractice in connection with surgeries involving Medtronic's controversial Infuse bone graft. UCLA said it doesn't comment on pending litigation. Wang couldn't be reached for comment.
Shortly after raising his concerns, Pedowitz said, he was pressured to step down as department chairman in 2010. Pedowitz said he was further retaliated against by being denied patient referrals and prevented from participating in grants and other activities.
Before UCLA, Pedowitz worked at UC San Diego and as chairman of orthopedics and sports medicine at the University of South Florida.
Mark Quigley, an attorney representing Pedowitz, said the case could have been avoided if the UC system enforced the policies it already has in place.
"What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" Quigley said. "The university wanted to cover it all up."
Wednesday, November 30, 2011
Hospitals target pricey medical devices for savings
Analysis: Hospitals target pricey medical devices for savings
By Susan Kelly
Nov 29, 2011
(Reuters) - When U.S. hospitals cut expenses as the economy slid into recession, they looked first to basic supplies like lightbulbs and bandages. Next on the list: artificial hips and knees.
Implantable devices make up a sizable chunk of typical hospital budgets, and administrators are devising new ways to limit that cost as they brace for cuts to government reimbursement and treat more patients who can't pay for care.
That means methodically working through each category of device, from heart valve replacements and stents to spinal products, to see where they can negotiate lower prices. It also means creating databases of shared information on pricing between hospitals.
"We are pressing very hard on device makers because it is a big piece of the supply puzzle," said Michael Rosenblatt, vice president of supply chain management for SSM Health Care, a St Louis-based system with 15 acute-care hospitals.
Heart and orthopedic device makers have already seen their pricing power erode as patients forgo expensive treatments in the struggling economy, and the new push by hospitals will only intensify that pressure.
"Things are getting worse from a pricing standpoint. The big area of focus is the high-priced cardiac and orthopedic stuff. It's bad, and it's getting worse for everyone," said Mizuho Securities analyst Michael Matson.
Further hampering device makers are product portfolios full of mature technologies that make it harder to justify premiums. Drug-eluting stents are the most extreme example, Matson said, with annual price declines of 10 percent worldwide.
Prices also are falling, though not as dramatically, on pacemakers and defibrillators sold by companies such as Medtronic Inc, Boston Scientific Corp and St Jude Medical Inc, and orthopedic implants made by Stryker Corp and others.
"It's beginning to shift to where manufacturers understand that a lot of these products are really becoming more like commodities," said Christopher Baskel, supply chain director at Spectrum Health Hospital Group, a chain of nine hospitals based in Grand Rapids, Michigan.
Spectrum has found ways to cut costs in major device categories one by one, beginning with stents, then pacemakers and defibrillators, and recently spine devices. "We just got done doing orthopedic spine. We're starting on hips and knees next, after the first of the year," Baskel said.
To gain an advantage in negotiations with device makers, Spectrum is participating in an information exchange set up through its group purchasing organization, Novation, that allows members to see what other hospitals are paying for products. Company names are blinded.
"There is very little price transparency on these high-end sophisticated devices," said Baskel. "We've been working hard to lift the price transparency veil. We are not going to be satisfied until it's like Amazon.com."
CORRECTIVE MEDICINE
Americans pay far more for healthcare than patients in other developed countries but die earlier, according to the 34-nation Organization for Economic Cooperation and Development. They are among the top consumers of costly procedures including hip and knee replacements, MRIs and CT scans. For a graphic, see: link.reuters.com/pyr35s
Such statistics have put greater scrutiny on the role of device makers in driving unsustainable healthcare costs. The U.S. healthcare overhaul also gives financial incentives to hospitals and doctors to collaborate on cost savings while improving the quality of care for patients enrolled in the government's Medicare plan for the elderly.
"If you look at the healthcare system, the pressures are going to flow to those who can absorb them, and these guys have a lot of profit," Mizuho's Matson said.
Closer on the horizon, device makers face a 2.3 percent tax on their product sales beginning in 2013 to help pay for health reform. Stryker earlier this month said it would cut 5 percent of its workforce to help offset the device tax.
David Nexon, senior executive vice president for the Advanced Medical Technology Association (Advamed), which represents device makers, said some of the emphasis on cost is short-sighted. Devices such as artificial knees keep people out of nursing homes while new minimally invasive surgical techniques reduce the length of hospital stays, he said.
An Advamed-sponsored study found that medical device spending has remained constant at about 6 percent of national health expenditures over a 20-year period through 2009.
"If you look at price data, it doesn't suggest that we are a driver of higher costs, but certainly we've been a driver of greater value," Nexon said.
On the other side of the ledger, hospitals are caring for more people who rely on government programs or have no insurance at all as unemployment remains high. That is straining emergency rooms, which are required by law to provide treatment regardless of ability to pay.
The burdens brought by the struggling economy are making hospitals even more vulnerable to government efforts to reduce the national deficit by cutting the reimbursements they receive.
Premier Inc, a purchasing alliance for more than 2,500 U.S. hospitals, estimates that healthcare providers can expect cuts in reimbursement payments to reach 15 percent to 20 percent of current levels by 2017. So when hospitals look for places to cut, medical devices make even more sense.
DOING THE MATH
Hospitals are already losing thousands of dollars each time they perform one of the top dozen device implant procedures on a Medicare patient, according to Premier, which maintains a large database of patient claims and consults with its members on ways to improve their finances and quality of care.
For example, hospitals in a recent Premier analysis lost almost $15,000 on average for each cardiac valve replacement procedure performed on a Medicare patient.
Hospital administrators compare that with the robust profit margins traditionally enjoyed by medical device makers.
Operating margins for large medical device makers typically range from 25 percent to 28 percent, compared with 7 percent to 10 percent for publicly traded hospital operators, according to Thomson Reuters data. The spread on gross margins is even greater, with device makers in the 70 percent to 80 percent range compared with 35 percent to 55 percent for hospitals, according to analysts...
By Susan Kelly
Nov 29, 2011
(Reuters) - When U.S. hospitals cut expenses as the economy slid into recession, they looked first to basic supplies like lightbulbs and bandages. Next on the list: artificial hips and knees.
Implantable devices make up a sizable chunk of typical hospital budgets, and administrators are devising new ways to limit that cost as they brace for cuts to government reimbursement and treat more patients who can't pay for care.
That means methodically working through each category of device, from heart valve replacements and stents to spinal products, to see where they can negotiate lower prices. It also means creating databases of shared information on pricing between hospitals.
"We are pressing very hard on device makers because it is a big piece of the supply puzzle," said Michael Rosenblatt, vice president of supply chain management for SSM Health Care, a St Louis-based system with 15 acute-care hospitals.
Heart and orthopedic device makers have already seen their pricing power erode as patients forgo expensive treatments in the struggling economy, and the new push by hospitals will only intensify that pressure.
"Things are getting worse from a pricing standpoint. The big area of focus is the high-priced cardiac and orthopedic stuff. It's bad, and it's getting worse for everyone," said Mizuho Securities analyst Michael Matson.
Further hampering device makers are product portfolios full of mature technologies that make it harder to justify premiums. Drug-eluting stents are the most extreme example, Matson said, with annual price declines of 10 percent worldwide.
Prices also are falling, though not as dramatically, on pacemakers and defibrillators sold by companies such as Medtronic Inc, Boston Scientific Corp and St Jude Medical Inc, and orthopedic implants made by Stryker Corp and others.
"It's beginning to shift to where manufacturers understand that a lot of these products are really becoming more like commodities," said Christopher Baskel, supply chain director at Spectrum Health Hospital Group, a chain of nine hospitals based in Grand Rapids, Michigan.
Spectrum has found ways to cut costs in major device categories one by one, beginning with stents, then pacemakers and defibrillators, and recently spine devices. "We just got done doing orthopedic spine. We're starting on hips and knees next, after the first of the year," Baskel said.
To gain an advantage in negotiations with device makers, Spectrum is participating in an information exchange set up through its group purchasing organization, Novation, that allows members to see what other hospitals are paying for products. Company names are blinded.
"There is very little price transparency on these high-end sophisticated devices," said Baskel. "We've been working hard to lift the price transparency veil. We are not going to be satisfied until it's like Amazon.com."
CORRECTIVE MEDICINE
Americans pay far more for healthcare than patients in other developed countries but die earlier, according to the 34-nation Organization for Economic Cooperation and Development. They are among the top consumers of costly procedures including hip and knee replacements, MRIs and CT scans. For a graphic, see: link.reuters.com/pyr35s
Such statistics have put greater scrutiny on the role of device makers in driving unsustainable healthcare costs. The U.S. healthcare overhaul also gives financial incentives to hospitals and doctors to collaborate on cost savings while improving the quality of care for patients enrolled in the government's Medicare plan for the elderly.
"If you look at the healthcare system, the pressures are going to flow to those who can absorb them, and these guys have a lot of profit," Mizuho's Matson said.
Closer on the horizon, device makers face a 2.3 percent tax on their product sales beginning in 2013 to help pay for health reform. Stryker earlier this month said it would cut 5 percent of its workforce to help offset the device tax.
David Nexon, senior executive vice president for the Advanced Medical Technology Association (Advamed), which represents device makers, said some of the emphasis on cost is short-sighted. Devices such as artificial knees keep people out of nursing homes while new minimally invasive surgical techniques reduce the length of hospital stays, he said.
An Advamed-sponsored study found that medical device spending has remained constant at about 6 percent of national health expenditures over a 20-year period through 2009.
"If you look at price data, it doesn't suggest that we are a driver of higher costs, but certainly we've been a driver of greater value," Nexon said.
On the other side of the ledger, hospitals are caring for more people who rely on government programs or have no insurance at all as unemployment remains high. That is straining emergency rooms, which are required by law to provide treatment regardless of ability to pay.
The burdens brought by the struggling economy are making hospitals even more vulnerable to government efforts to reduce the national deficit by cutting the reimbursements they receive.
Premier Inc, a purchasing alliance for more than 2,500 U.S. hospitals, estimates that healthcare providers can expect cuts in reimbursement payments to reach 15 percent to 20 percent of current levels by 2017. So when hospitals look for places to cut, medical devices make even more sense.
DOING THE MATH
Hospitals are already losing thousands of dollars each time they perform one of the top dozen device implant procedures on a Medicare patient, according to Premier, which maintains a large database of patient claims and consults with its members on ways to improve their finances and quality of care.
For example, hospitals in a recent Premier analysis lost almost $15,000 on average for each cardiac valve replacement procedure performed on a Medicare patient.
Hospital administrators compare that with the robust profit margins traditionally enjoyed by medical device makers.
Operating margins for large medical device makers typically range from 25 percent to 28 percent, compared with 7 percent to 10 percent for publicly traded hospital operators, according to Thomson Reuters data. The spread on gross margins is even greater, with device makers in the 70 percent to 80 percent range compared with 35 percent to 55 percent for hospitals, according to analysts...
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