Collision of Archaic 1976 Congressional Legislation & Power Morcellator and Bayer Essure PREVENTABLE Harm

Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA  November 18, 2015

By Matthew Bin Han Ong

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

 

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

“Are you aware of this problem?” Murphy asked Shuren. “[Johnson & Johnson] was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. [Robert] Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer, which is morcellated.”

At the hearing, Murphy pressed FDA’s Shuren on how much the agency knew about these incidents.

“Let me ask another question: Brigham & Women’s Hospital was aware of the dangers in 2012,” Murphy said. “A patient by the name of Mrs. Erica Kaitz was seriously injured in 2012 by the device and then died in 2013, according to reports.

“I wonder, do you know if the hospital reported that to the FDA? Would you know?”

Shuren: “I’m not aware of that.”

Contacted by The Cancer Letter after the hearing, Brigham declined to comment. The J&J subsidiary Ethicon said the company wasn’t aware of any reportable adverse events prior to December 2013.

“Dr. Lamparter did contact the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation,” an Ethicon spokesperson acknowledged to The Cancer Letter.

However, the company spokesman said the communication didn’t constitute a reportable event. “Because Dr. Lamparter did not report an actual experience with a patient, his communication was handled as a complaint, and was not reportable as an MDR,” the spokesman said.

A story about Lamparter’s report to J&J appears here.

In an earlier statement to The Cancer Letter, FDA said it received no reports of adverse outcomes before December 2013. Since then, the agency was informed of about two dozen cases of upstaging of cancer via power morcellation at a variety of health care institutions.

FDA’s answers to questions from The Cancer Letter are posted here.

The congressional hearing this week was part of a string of investigations of the controversy stemming from widespread use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.

The questions also stem from correspondence between FDA and Rep. Mike Fitzpatrick (R-Pa.), who is not a member of Energy & Commerce. Fitzpatrick became involved in response to advocacy by his constituents Amy Reed and Hooman Noorchashm (The Cancer Letter, Nov. 13).

Reed’s uterine sarcoma was upstaged as a result of a power morcellation surgery performed at Brigham.

“Under section 519 of the [Federal Food, Drug, and Cosmetic] Act (see also 21 CFR part 803), manufacturers must report to FDA information that suggests that a device they market may have caused or contributed to a death or serious injury,” the agency said in a Nov. 12 letter to Fitzpatrick. “Moreover, user facilities must report device-related serious injuries to the manufacturer and device-related deaths to the manufacturer and FDA.

“FDA has taken enforcement action in the past against user facilities and manufacturers who fail to comply with FDA’s reporting requirements. We have generally focused our enforcement resources on manufacturers—who are required under law to investigate any MDR-reportable complaint they receive—and not on user facilities. We have found that encouraging more reporting—and more complete reporting—by user facilities is a good use of our limited resources in this area,” FDA wrote in response to Fitzpatrick’s questions.

Fitzpatrick’s letter and the agency’s response are posted here.

“You will note that it is an incomplete response,” a spokesperson for Rep. Fitzpatrick said to The Cancer Letter. “We will be sending out a full release when we get a complete response.”

Separately, the Federal Bureau of Investigation is reportedly looking into the issue, and the Government Accountability Office is investigating the controversy at the behest of 12 members of Congress (The Cancer Letter, May 29, Sept. 11).

In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging Erica Kaitz’s leiomyosarcoma via power morcellation. Kaitz died on Dec. 7, 2013, nearly two months after Reed received her cancer diagnosis at Brigham (The Cancer Letter, Nov. 26, 2014).

Her widower Richard Kaitz, a Boston real estate lawyer, said that Brigham doctors mischaracterized the risk his wife was facing when she underwent power morcellation.

“They gave us numbers—one out of 10,000—that they knew to be wrong,” Kaitz said to The Cancer Letter last year. “The Seidman, Muto article was published in November 2012. It says right in that article that multiple parties at Brigham said that the number they are quoting for the risk are nine times lower than the real risk.”

https://vimeo.com/146065667

A transcript of the exchange between Murphy and Shuren follows:

Rep. Tim Murphy: Doctors, doctors, good to have you here. I appreciate this. I want to pivot a little here to talk about and piece together postmarket and premarket analysis and to look at this. In particular, a couple of devices used in women’s health care.

One is called a morcellator. Are you familiar with the morcellator? A device that is supposed to shred tumors etc. but has been associated with complications in women in terms of actually spreading cancer for them. It’s been on the market for 20-plus years, and FDA admitted for the first time it became aware of the safety issue with power morcellators after December 2013—correspondence from a physician citing a case of a family member.

This is someone who just recently had another surgery to remove another recurrence of cancer that was spread by the morcellator. The manufacturer [Johnson & Johnson] was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. [Robert] Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer, which is morcellated.

My question is, did the FDA have any evidence of these dangers in 2006 or prior to that? Are you aware of this problem?

Jeffrey Shuren: In the past, the thought was that the risk—what risk of cancer there may be for a fibroma, for a fibroid—was significantly less, and one of the things that we looked into more recently, we came to a different conclusion that the likelihood of cancer is higher.

There’s still disagreement in the community, because, as you know, the [gynecology] health care professional societies disagree. They think we have overestimated the risk of the cancer, we said we have a different perspective, and that’s why we went out and we put contraindications and warnings on the use of that device, that it should only be used in a more limited set—or offered as an option—of women, and think about primarily women who, in the absence of using the device, would no longer be able to bear children, but want to bear children, and we felt in those cases the risk of a cancer is very low. They share the opportunity to weigh in, but we scaled back dramatically how that should be used.

TM: So there’s a case where the science available at the premarket analysis has changed, and once being used in the data, you have a mechanism to go forward on this and make some changes.

Let me ask another question: Brigham & Women’s Hospital was aware of the dangers in 2012. A patient by the name of Mrs. Erica Kaitz was seriously injured in 2012 by the device and then died in 2013, according to reports.

I wonder, do you know if the hospital reported that to the FDA? Would you know?

JS: I’m not aware of that.

TM: Is there a mechanism where the hospital is supposed to report that, or the manufacturer is supposed to report that so you can do an analysis?

JS: So, user facilities have certain requirements for reporting, so do manufacturers, if they become aware of certain events. And what I can tell you is we’ve been looking into those concerns that have been raised regarding reporting.

TM: OK. In a response to Congressional inquiries about this, the FDA admitted that the one out of 350 risk does not address other types of malignancies, which, you would add to that risk, you said. They went on to say the FDA also identified studies showing that morcellated patients had worse outcomes than patients who had not undergone morcellation.

So, this is more than just the issue with just a fibroid or if it’s cancerous. It is also a question of outcomes. Is this something that the FDA is reviewing, also with regard to their stamp of approval on these things, in terms of the outcome measures?

JS: So in terms of the tests we’ve looked at, we think where we have constrained it right now, is for use—is where the benefits outweigh the risks, but we are continuing to look at new data as it arises, and if so, we will act accordingly.

TM: Thank you. There is another issue in women’s health as brought to my attention. It’s a product called Essure. It’s a permanent birth control device that went through FDA’s rigorous premarket approval process.

Yet, despite getting the agency’s approval, it’s been linked to at least four deaths and deaths of five unborn children. Apparently, a total of 24,000 women have come forward, claiming that they have been harmed by this device.

And so the question is, how it remains on the market with potential for problems, and because this has the FDA stamp of approval, these women feel disappointed—they cannot take their cases forward, and feel they don’t have any recourse.

Is the FDA also reviewing this issue as well?

JS: In fact, we held an advisory committee meeting a few weeks ago at our behest to give an opportunity to put what new evidence is on the table to assure that people who wanted to raise concerns about it had an opportunity to provide those concerns.

And we are now currently reviewing the feedback received from the advisory committee, as well as what we have heard from other people as well as the state of the evidence, and we will come out with our conclusions on that to the public.

TM: Thank you. And as this goes through, since this hearing is a lot about premarket analysis, what this comes down to is, I just want to make sure that we are aware of what mechanism you have, because I understand the science of 1996 is different from the science of 2015 and our knowledge base, but to have an ongoing mechanism for review and changes of devices and getting information there and looking at those things.

I’m glad you had some hearings on this, but I’d certainly like to know that that’s part of the system. I’m out of time, but I look forward to hearing your comments on that in the future. Thank you.

https://vimeo.com/146065667

http://www.cancerletter.com/articles/20151119_1

GAO to investigate FDA regulation of power morcellators.

Government Watchdog to Investigate Hysterectomy Device Found to Spread Uterine Cancer

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

By JON KAMP

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

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

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

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

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

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

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

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

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

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

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

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

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

"one of the worst offenders" orthopedic surgery overuse . . .

Orthopedists' Financial Conflicts Can Hurt Patients, Surgeon Says

Cheryl Clark, for HealthLeaders Media , March 17, 2015  FiDA highlight added

It is financially compelling for many doctors to do things that aren't really going to help their patients, says an orthopedist who is leading a campaign against surgical overuse.

Financial conflicts of interest often drive physicians to perform worthless surgeries, but the field of orthopedics "is one of the worst offenders," says an Indiana orthopedist who has launched a "moral persuasion" campaign to persuade his colleagues to stop.

"It's really hard for doctors to acknowledge this and change their ways," says James Rickert, MD, who years ago founded the Society for Patient Centered Orthopedic Surgery to address the problem.

It's especially tough for doctors who own related businesses that depend on surgical volume, which puts even more pressure on them to "be more like businessmen instead of doctors," he says.

A lot of orthopedic surgeons "own part of the distributorships that sell the total hip or knee implants to the hospital, and they'll make a ton of money on that. Or they own the imaging center they send their patients to. They own a piece of the surgical center. They know if they're not doing a lot of surgery, they may lose money on their overhead," Rickert says.

A series of four reports from the Government Accountability Office documents greater numbers of procedures referred by physicians who own providing businesses, compared to referrals from non-owners.

"That makes it really compelling for doctors to do things that aren't really going to help their patients. They become more like salesmen, saying things like, 'Well, it might help.' Or, 'We don't have much to lose, let's try it,' knowing full well the data shows there's very little chance the procedure will help and some evidence the patient could be hurt."

Rickert has long been aware of surgical overuse, including his own. But he didn't work hard to stop it until he himself got sick. He was diagnosed with non-Hodgkin Lymphoma at age 42, underwent chemotherapy, bone marrow, and stem cell transplants, recurrences, and foul-ups in his care. Now 54, he's been cancer free for five years. 

"I was accessing the system every day for months as a very sick person, having a lot of problems. I started to think about patient-centered care expectations and how different that is from reality."

As he got better and returned to his Bloomington practice, he founded the society to appeal to surgeons' consciences. So far, 14 fellow orthopedists have joined his effort.

Performing unnecessary surgeries, he says, "is not [necessarily] below the standard of care. For example, the doctor can usually say, 'Hey, he had a torn medial meniscus and here's an MRI that proves it,' even though it was not the right thing for a severely arthritic patient."

"I certainly have a lot of patients referred to me from nearby. And when I look at the surgery and pathology they had, I just know that there was no way that doctor really thought that was going to help them."

At the Lown Institute conference in San Diego last week Rickert described one of many sad cases. Two decades after performing a successful knee scope on a patient, the now severely arthritic patient returned, seeking another scope. Rickert advised that it would not help and could cause problems.

The patient went to another orthopedist and had the procedure. This surgeon thought the worst that would happen would be the patient wouldn't be any better, but would at least be satisfied that the doctor had tried to help. "Instead, the patient gets a deep vein thrombosis that turns into a pulmonary embolism, and two days later he's dead," Rickert says.   

For doctors, it's like an inside secret, he says. "We know about these risks, but the patients don't."

Rickert and some of his colleagues also criticize the American Academy of Orthopedic Surgeons' Choosing Wisely list of five procedures doctors and patients should avoid. None on the academy's current list is especially common or very important, Rickert says. 

Kevin Bozic, MD, chair of the AAOS Council on Research and Quality, said via email that the Choosing Wisely list was created from systematic reviews of the literature and is limited to available evidence that various treatment options for musculoskeletal conditions are effective, "which we are seeking to improve." AAOS is working to define appropriateness criteria incorporating patient preferences and values into medical decision-making, he said. Since it submitted its list of five practice guidelines in 2012, AAOS has published four more to be reviewed for possible inclusion in a second Choosing Wisely list.

At the conference, Rickert and Rob Rutherford, MD, an orthopedic surgeon from Coeur d'Alene, ID, presented what they say is a more relevant list of procedures that are frequently performed, usually unnecessary, high cost, and sometimes harmful:

1. Vertebroplasty
Cost: $10,000 

The percutaneous injection of cement into a fractured vertebra. The procedure, done in about 100,000 patients a year, is falsely marketed as relieving pain quickly. But in clinical trials, pain relief was similar to that seen in patients who underwent sham surgery. The procedure's risks include compression fractures in adjacent vertebrae, dural tears, infections, cement migration, and nerve pain that requires subsequent surgery.

2. Rotator Cuff Repairs in Elderly Patients

Cost: $15,000

About 600,000 such surgeries are performed in the U.S. each year. The number of surgeries increased by 141% between 1996 and 2006. This surgery is vastly overused on patients who are asymptomatic. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots, and the need for repeat surgery to correct the first procedure.

3. Clavicle fracture repair or "plating" in adolescents
Cost: $13,000
This procedure is performed in a small percentage of adolescents each year to improve function. "I don't know of any good indication, especially with conservative care being so successful" and rarely does the surgery benefit, Rickert says.  

Regardless of patient age, type of sport, and final clavicle shortening, there's no differences in pain, strength, or range of motion. But there is a risk of deep infections, pneumothorax, and other complications. 

4. Anterior Cruciate Ligament Tear Repair in Low-Risk individuals
Cost: $10,000
ACL surgeries are performed in 100,000 patients a year and carry high risks but demonstrate no difference in rates of return to pivoting-activity sports one year later than conservative rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar fracture and growth plate injury in children.

5. Surgical Removal of Part of a Torn Meniscus 

Cost: $6,000
Annually, this surgery is performed in 700,000 patients with knee arthritis and no mechanical symptoms. But it does not provide significant benefit compared with sham surgery in patients with degenerative meniscal tears. There's equal pain relief and functional status.

Rickert, who is on the faculty of the Indiana University School of Medicine, emphasizes that IU Health has a policy forbidding its doctors from accepting money or gifts from the pharmaceutical or medical device industries.

He says his specific orthopedic group does not own an MRI or an orthopedic surgery center. And he acknowledges that he gets "e-mails and grouchy comments from doctors [at other organizations] who want me to not do this [campaign]."  

"There's still a lot of resistance from entrenched interests. But we have to show doctors the data, studies that show this doesn't work, and then ask, 'why are we still doing this?' We have to confront them with the data."

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists. 

http://www.healthleadersmedia.com/print/QUA-314383/Orthopedists-Financial-Conflicts-Can-Hurt-Patients-Surgeon-Says

If my knees were a car, my mechanic would choose my next automobile!

Landers: Knee replacements make for strange healthcare economics

Jim Landers

jlanders@dallasnews.com

Published: 12 May 2014 09:15 PM

Updated: 12 May 2014 09:44 PM  FiDA highlight

WASHINGTON — This winter, I had my knees replaced. I used a surgeon and a hospital in my neighborhood of Alexandria, Va., not far from where I work. The surgery and rehab are going fine. The lessons in health care economics are becoming strange.

For each knee, the bills (hospital, surgeon, anesthesiologist) came to roughly $32,000. Michael Toomey, president of Compass Care Engineering in Dallas, says the average in the Dallas area is between $42,000 and $43,000.

My new mechanical knees were the most expensive items in the bills. The hospital wanted $16,097.05 for each of them. My insurance agreed to pay $10,982.72 apiece.

These are Sigma System knees, size 5, made by DePuy Orthopaedics of Warsaw, Ind. DePuy is part of Johnson & Johnson.

The knees are made of cobalt, chrome and polyethylene. There’s a buckle-like piece that fits over the knee tip of my thigh bone. There’s a piece that looks like a peg with a circle on it drilled into my shin bone. Between them is a plastic disc. On the back of the knee cap, there’s a metal dome.

My surgeon chose these knees. The hospital bought them. Insurance (and my out-of-pocket max of $3,000) paid for them.

So, let’s see, if my knees were a car, my mechanic would choose my next automobile. A garage would buy it, and add its own markup. My employer (which is where I get health insurance) would pay for most of it, using an insurance administrator to bargain over the price.

Survey of surgeons

This is standard practice in the medical world. Device manufacturers will pitch their products to surgeons, but the surgeons are often in the dark or heedless of the cost. A survey cited in the January issue of Health Affairs found that 81 percent of orthopedic surgeons could not accurately guess the cost of these devices. And American surgeons replace about 720,000 knees a year.

Baylor Scott & White Health is using a different approach. The surgeons and the supply people meet to talk openly about prices and quality. They agree on a price the hospital system will pay. Medical device makers are then invited to meet or beat that price.

“Everybody can play, but you have to meet this capitated [maximum] price,” said Pam Bryant, Baylor Scott & White’s senior vice president for supply chain services.

Surgeons can choose among four or five key types, Bryant said.

Texas Health Resources also negotiates as a chain for its joint replacements. But here, the surgeons can choose what they like.

“While there is a great deal of similarity between devices, surgeons have definite preferences based upon training and their individual style of surgery — as well as the individual patient needs, including age, activity and other factors,” said John Gaida, THR’s senior vice president for supply chain management.

“Texas Health strives to make virtually all brands of hip and knee implants available to our surgeons so that the patient needs are always the primary consideration,” he said.

Across the country, surgeons are not clued in on the cost of medical devices often because the hospital can’t share that information. They typically sign a contract with the medical device company that forbids disclosure.

Doctors order

I know little about mechanical knees. My surgeon implants them all the time, so it makes sense to follow his guidance on what would suit me best and last longest.

But we didn’t go over a list of knees and manufacturers. My surgeon asked about my lifestyle, looked at my age and weight, and chose for me.

The hospital did the negotiating with DePuy. Did they get a good deal?

A 2012 Government Accountability Office report covering a small sample of hospitals found that one paid $5,200 for a knee replacement while another paid $9,500 for the same device.

There are several types of knees on the market. There’s a standard, fixed-bearing knee; a rotational knee that can handle more twists and turns; and a rotational/full flexion knee that allows for deep squats.

Prices seem to run between $2,000 and $16,000 for the device. So it turns out that my new knees (rotational) are pretty high-end. I hope they last a long time.

Follow Jim Landers on Twitter at @landersjim.