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Updated: 1 hour 46 min ago

From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

July 09, 2024

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,'” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Closing of Rural Hospitals Leaves Towns With Unhealthy Real Estate

June 26, 2024

JELLICO, Tenn. — In March 2021, this town of about 2,000 residents in the hills of east Tennessee lost its hospital, a 54-bed acute care facility. Campbell County, where Jellico is located, ranks 90th of Tennessee’s 95 counties in health outcomes and has a poverty rate almost double the national average, so losing its health care cornerstone sent ripple effects through the region.

“Oh, my word,” said Tawnya Brock, a health care quality manager and a Jellico resident. “That hospital was not only the health care lifeline to this community. Economically and socially, it was the center of the community.”

Since 2010, 149 rural hospitals in the United States have either closed or stopped providing in-patient care, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina. Tennessee has recorded the second-most closures of any state, with 15, and the most closures per capita. Texas has the highest number of rural hospital closures, with 25.

Each time a hospital closes there are health care and economic ripples across a community. When Jellico Medical Center closed, some 300 jobs went with it. Restaurants and other small businesses in Jellico also have gone under, said Brock, who is a member of the Rural Health Association of Tennessee’s legislative committee. And the town must contend with the empty husk of a hospital.

Dozens of small communities are grappling with what to do with hospitals that have closed. Sheps Center researchers have found that while a closure negatively affects the local economy, those effects can be softened if the building is converted to another type of health care facility.

In Jellico, the town owns the building that housed the medical center, and Mayor Sandy Terry said it is in decent condition. But the last operator, Indiana-based Boa Vida Healthcare, holds the license to operate a medical facility there and has yet to announce its plans for the building, leaving Jellico in limbo. Terry said local officials are talking with health care providers that have expressed interest in reopening the hospital. That’s their preferred option. Jellico does not have a Plan B.

“We’re just in hopes that maybe someone will take it over,” Terry said. Meanwhile, the nearest emergency rooms are a half-hour drive away in LaFollette, Tennessee, and across the state line in Corbin, Kentucky.

An hour and a half away in Fentress County, the building that once housed Jamestown Regional Medical Center has been empty since June 2019, when Florida-based Rennova Health — which also previously operated Jellico Medical Center — locked it up.

County Executive Jimmy Johnson said Rennova’s exit from Jamestown was so abrupt that “the beds were all made up perfectly” and IV stands and wheelchairs sat in the halls. About 150 jobs evaporated when the center closed.

Rennova still owed Fentress County $207,000 in taxes, Johnson said, and in April the property was put up for auction. A local business owner purchased it for $220,000. But Rennova was granted a year to reacquire the building for what it owed in back taxes, plus interest, and did so within a few days.

Abandoned hospital buildings dot the map in central and east Tennessee. But in the western part of the state, two communities found uses for their empty buildings, albeit not in reopening hospitals.

Somerville, about an hour east of Memphis, lost its hospital, Methodist Fayette, in 2015. Its parent company, Methodist Le Bonheur Healthcare, donated the building to the town and threw in $250,000. The building is now a satellite campus for the University of Tennessee-Martin.

The conversion was pushed along by the town leveraging other funding. Bob Turner, Somerville’s city administrator, said both the town and the county matched Methodist’s quarter-million dollars toward the renovation. In its first year in Somerville, the university raised another $125,000. Tennessee’s governor then matched that $875,000 in his state budget.

Somerville is now in the seventh year of a 10-year agreement with the university, which rents the building from the town.

“We have a building, an asset, that’s probably worth $15 million,” Turner said. “It’s a four-year university right here in the heart of Fayette County.”

Mendi Donnelly, Somerville’s community development director, said the county is still in desperate need of a hospital, but “we’re thrilled that we were able to make lemonade out of our lemons.”

Ninety miles to the northeast, in rural Carroll County, Tennessee, another shuttered hospital found new life.

The closing of McKenzie Regional Hospital in 2018 was a blow to the local economy. But Baptist Memorial Health Care, which operates a hospital in nearby Huntingdon, bought the assets — including the building, land, equipment, and ambulance service — and subsequently donated the building to the town of McKenzie.

Cachengo, a technology company, ultimately took over the space. Because of hospitals’ electrical infrastructure, the site was a perfect fit for a business like his, said Ash Young, Cachengo’s chief executive. Young said Cachengo is now looking into repurposing abandoned hospitals across the country.

Jill Holland, McKenzie’s former mayor and a local-government and special-projects coordinator for the Southwest Tennessee Development District, believes the town can become a technology hub.

“It’s opening a lot of doors of opportunity for the youth in the community,” Holland said.

Back in Jamestown, the vacant hospital is “deteriorating,” said Johnson, the county executive. “It could have been used to save lives.” Rennova did not respond to a request for comment.

The University of Tennessee Medical Center opened a freestanding emergency room elsewhere in Jamestown, sparing residents a half-hour drive to the closest ER. Johnson believes the old hospital building could serve the community as housing for those who are homeless or as a facility to treat substance use disorder.

Brock, the health care quality manager, thinks things will get better in Jellico, but the community has had its hopes dashed more than once.

Brock believes a freestanding emergency room could be a viable solution. She urges her community to be responsive to “a new day” in rural health in America, one in which a hospital must focus on its community’s most urgent needs and be realistic about what that hospital can provide.

“Maybe it is just the emergency room, a sustainable emergency room, where you could hold patients for a period of time and then transfer them,” Brock said. “And then you build upon that.”

She added, “There are options out there.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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California’s $25 Health Care Hourly Wage Relies on Federal Boost, State Worker Exemption

June 26, 2024

SACRAMENTO, Calif. — California’s nation-leading $25 minimum wage for health workers will rely on a significant boost in federal funding and exempt thousands of state employees under an agreement that is expected to be approved in the coming days.

The minimum wage hike for more than 400,000 health workers, which will be phased in over several years, was to start June 1, but will now begin no earlier than Oct. 15 and no later than Jan. 1 under a budget deal announced June 22. The legislature is expected to approve the changes and Gov. Gavin Newsom to sign them into law before the new fiscal year begins July 1.

The delay is just one of several health-related measures in the nearly $300 billion state spending plan. The budget includes about $800 million in cuts to public health and health care workforce programs, but they are less severe than what Newsom initially proposed. It includes an 8% reduction in public health spending and preserves in-home support for Medi-Cal recipients regardless of their legal status. It counts on nearly $1.8 billion in additional revenue from the Managed Care Organization tax.

Newsom, a Democrat, had wanted an annual trigger that would have delayed the health worker wage bumps in tight budget years like this one, when the state faced a nearly $47 billion deficit.

Instead, Democratic leaders who control the legislature agreed to a one-time trigger that will start the increases in October if state revenues come in 3% higher than expected, or no later than in January after the state increases what is known as the Hospital Quality Assurance Fee, which allows hospitals to tax themselves to draw in federal money for Medi-Cal, the state’s Medicaid program.

Budget officials expect the fee increase to cover about 30% of the minimum wage increases. The fee currently provides about $8.4 billion to California hospitals each year and officials project that the unspecified increase will bring in billions of dollars more.

The fee increase requires federal approval, but budget officials said they believe even such a large increase is allowed under federal guidelines. The Newsom administration plans to hash out the details with hospitals over the next several months.

The managed care plans will still have to compensate for the remaining increased minimum wage costs with higher Medi-Cal managed care rates, budget officials said.

However, the administration said hospitals expect the wage bumps “will not result in significant additional costs.” That differs from what the California Hospital Association said in successfully contesting a $25 minimum wage in one Southern California city. The association said it was reviewing the plan.

The California Association of Health Plans did not comment. The California Kidney Care Alliance said many dialysis providers already increased wages ahead of the new requirements.

The law originally excluded employees at the Department of State Hospitals, and state budget officials said the new bill extends that to exclude an estimated 21,000 employees at all health care facilities operated by the state, with the exception of the University of California system. Proponents have said the wage increases would have included employees at the departments of Corrections and Rehabilitation, Developmental Services, and Veterans Affairs.

“Of course, workers are disappointed that not every low-wage worker in health care will receive raises this summer as the law initially scheduled,” said Dave Regan, president of Service Employees International Union-United Healthcare Workers West, which pushed for the increases over the state’s $16 minimum wage. But he praised Democratic leaders for recognizing that “despite a historic budget deficit, California’s patient care and health care workforce crisis must be addressed.”

The University of California-Berkeley Labor Center projected that more than 469,000 health workers would get wage increases, with the biggest benefits going to women and workers of color. The law covers lower-income employees including certified nursing assistants, patient aides, food service workers, janitors, groundskeepers, and security staff. California separately increased the minimum wage for fast-food workers to $20 an hour.

The health worker law originally was set to raise the hourly minimum at large health facilities and dialysis clinics to $23 this year, $24 in 2025, and $25 in 2026. It would have increased hourly wages at community clinics to at least $21 in 2024, $22 in 2026, and $25 in 2027. Other health facilities were to go to at least $21 an hour in 2024, $23 in 2026, and $25 by 2028.

The initial increases will be pushed back several months based on the one-time trigger.

Because the increases will start partway through the fiscal year, Newsom’s administration now projects the first-year cost to be $1.4 billion, down from its earlier full-year estimate of $4 billion.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).