From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
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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.
Oz did not respond to a request for comment on that statement.
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.
Subscribe to KFF Health News’ free Morning Briefing.
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Cassava vs Parsnip – Which is Healthier?
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Our Verdict
When comparing cassava to parsnips, we picked the parsnips.
Why?
This one wasn’t close!
In terms of macros, cassava has more than 2x the carbs while parsnips have nearly 3x the fiber, making for a very clear win for parsnips.
In the category of vitamins, cassava has more of vitamins B3 and C, while parsnips have more of vitamins B1, B2, B5, B6, B9, E, and K, with very large margins of difference in the latter two cases. Another overwhelming win for parsnips.
Looking at minerals, cassava is not higher in any minerals, while parsnips have more calcium, copper, iron, magnesium, manganese, phosphorus, potassium, selenium, and zinc; a very one-sided win for parsnips!
So, by all means enjoy either or both (diversity is good), but there’s a clear winner here today, and it’s parsnips.
Want to learn more?
You might like:
What Do The Different Kinds Of Fiber Do? 30 Foods That Rank Highest
Enjoy!
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52 Ways to Walk – by Annabel Streets
10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.
Most of us learned to walk at a very young age and probably haven’t thought much about it since, except perhaps in a case where some injury made it difficult.
Annabel Streets provides a wonderful guide to not just taking up (or perhaps reclaiming) the joy of walking, but also the science of it in more aspects than most of us have considered:
- The physical mechanics of walking—what’s best?
- Boots or shoes? Barefoot?
- Roads, grass, rougher vegetation… Mud?
- Flora & fauna down to the microbiota that affect us
- How much walking is needed, to be healthy?
- Is there such a thing as too much walking?
- What are the health benefits (or risks) of various kinds of weather?
- Is it better to walk quickly or to walk far?
- What about if we’re carrying some injury?
- What’s going on physiologically when we walk?
- And so much more…
Streets writes with a captivating blend of poetic joie-de-vivre coupled with scientific references.
One moment the book is talking about neuroradiology reports of NO-levels in our blood, the impact of Mycobacterium vaccae, and the studied relationship between daily steps taken and production of oligosaccharide 3′-sialyllactose, and the next it’s all:
“As if the newfound lightness in our limbs has crept into our minds, loosening our everyday cares and constraints…”
And all in all, this book helps remind us that sometimes, science and a sense of wonder can and do (and should!) walk hand-in-hand.
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Superfood Energy Balls
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They are healthy, they are tasty, they are convenient! Make some of these and when you need an energizing treat at silly o’clock when you don’t have time to prepare something, here they are, full of antioxidants, vitamins and minerals, good for blood sugars too, and ready to go:
You will need
- 1 cup pitted dates
- 1 cup raw mixed nuts
- ¼ cup goji berries
- 1 tbsp cocoa powder
- 1 tsp chili flakes
Naturally, you can adjust the spice level if you like! But this is a good starter recipe.
Method
(we suggest you read everything at least once before doing anything)
1) Blend all the ingredients in a good processor to make a dough
2) Roll the dough into 1″ balls; you should have enough dough for about 16 balls. If you want them to be pretty, you can roll them in some spare dry ingredients (e.g. chopped nuts, goji berries, chili flakes, seeds of some kind, whatever you have in your kitchen that fits the bill).
3) Refrigerate for at least 1–2 hours, and serve! They can also be kept in the fridge for at least a good while—couldn’t tell you how long for sure though, because honestly, they’ve never stayed that long in the fridge without being eaten.
Enjoy!
Want to learn more?
For those interested in some of the science of what we have going on today:
- Dates vs Figs – Which is Healthier?
- Why You Should Diversify Your Nuts!
- Goji Berries: Which Benefits Do They Really Have?
- The Sugary Food That Lowers Blood Sugars
- Enjoy Bitter Foods For Your Heart & Brain
- Capsaicin’s Hot Benefits
Take care!
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The Philosophy Gym – by Dr. Stephen Law
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If you’d like to give those “little gray cells” an extra workout, this book is a great starting place.
Dr. Stephen Law is Director of Philosophy at the Department of Continuing Education, University of Oxford. As such, he’s no stranger to providing education that’s both attainable and yet challenging. Here, he lays out important philosophical questions, and challenges the reader to get to grips with them in a systematic fashion.
Each of the 25 questions/problems has a chapter devoted to it, and is ranked:
- Warm-up
- Moderate
- More Challenging
But, he doesn’t leave us to our own devices, nor does he do like a caricature of a philosopher and ask us endless rhetorical questions. Instead, he looks at various approaches taken by other philosophers over time, and invites the reader to try out those methods.
The real gain of this book is not the mere enjoyment of reading, but rather in taking those thinking skills and applying them in life… because most if not all of them do have real-world applications and/or implications too.
The book’s strongest point? That it doesn’t assume prior knowledge (and yet also doesn’t patronize the reader). Philosophy can be difficult to dip one’s toes into without a guide, because philosophers writing about philosophy can at first be like finding yourself at a party where you know nobody, but they all know each other.
In contrast, Law excels at giving quick, to-the-point ground-up summaries of key ideas and their progenitors.
In short: a wonderful way to get your brain doing things it might not have tried before!
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What Harm Can One Sleepless Night Do?
10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.
We’ll not bury the lede: a study found that just one night of 24-hour sleep deprivation can alter immune cell profiles in young, lean, healthy people to resemble those of people with obesity and chronic inflammation.
Chronic inflammation, in turn, causes very many other chronic diseases, and worsens most of the ones it doesn’t outright cause.
The reason this happens is because in principle, inflammation is supposed to be good for us—it’s our body’s defenses coming to the rescue. However, if we imagine our immune cells as firefighters, then compare:
- A team of firefighters who are in great shape and ready to deploy at a moment’s notice, are mostly allowed to rest, sometimes get training, and get called out to a fire from time time, just enough to keep them on their toes. Today, something in your house caught fire, and they showed up in 5 minutes and put it out safely.
- A team of firefighters who have been pulling 24-hour shifts every day for the past 20 years, getting called out constantly for lost cats, burned toast, wrong numbers, the neighbor’s music, a broken fridge, and even the occasional fire. Today, your printer got jammed so they broke down your door and also your windows just for good measure, and blasted your general desk area with a fire hose, which did not resolve the problem but now your computer itself is broken.
Which team would you rather have?
The former team is a healthy immune system; the latter is the immune system of someone with chronic inflammation.
But if it’s one night, it’s not chronic, right?
Contingently true. However, the problem is that because the immune profile was made to be like the bad team we described (imagine that chaos in your house, now remember that for this metaphor, it’s your body that that’s happening to), the immediate strong negative health impact will already have knock-on effects, which in turn make it more likely that you’ll struggle to get your sleep back on track quickly.
For example, the next night you may oversleep “to compensate”, but then the following day your sleep schedule is now slid back considerably; one thing leads to another, and a month later you’re thinking “I really must sort my sleep out”.
See also: How Regularity Of Sleep Can Be Even More Important Than Duration ← A recent, large (n=72,269) 8-year prospective* observational study of adults aged 40-79 found a strong association between irregular sleep and major cardiovascular events, to such an extent that it was worse than undersleeping.
*this means they started the study at a given point, and measured what happened for the next eight years—as opposed to a retrospective study, which would look at what had happened during the previous 8 years.
What about sleep fragmentation?
In other words: getting sleep, but heavily disrupted sleep.
The answer is: basically the same deal as with missed sleep.
Specifically, elevated proinflammatory cytokines (in this context, that’s bad) and an increase in nonclassical monocytes—as are typically seen in people with obesity and chronic inflammation.
Remember: these were young, lean, healthy participants going into the study, who signed up for a controlled sleep deprivation experiment.
This is important, because the unhealthy inflammatory profile means that people with such are a lot more likely to develop diabetes, heart disease, Alzheimer’s, and many more things besides. And, famously, most people in the industrialized world are not sleeping that well.
Even amongst 10almonds readers, a health-conscious demographic by nature, 62% of 10almonds readers do not regularly get the prescribed 7–9 hours sleep (i.e. they get under 7 hours).
You can see the data on this one, here: Why You Probably Need More Sleep ← yes, including if you are in the older age range; we bust that myth in the article too!*
*Unless you have a (rare!) mutated ADRB1 gene, which reduces that. But we also cover that in the article, and how to know whether you have it.
With regard to “most people in the industrialized world are not sleeping that well”, this means that most people in the industrialized world are subject to an unseen epidemic of sleep-deprivation-induced inflammation that is creating vulnerability to many other diseases. In short, the lifestyle of the industrialized world (especially: having to work certain hours) is making most of the working population sick.
Dr. Fatema Al-Rashed, lead researcher, concluded:
❝In the long term, we aim for this research to drive policies and strategies that recognize the critical role of sleep in public health.
We envision workplace reforms and educational campaigns promoting better sleep practices, particularly for populations at risk of sleep disruption due to technological and occupational demands.
Ultimately, this could help mitigate the burden of inflammatory diseases like obesity, diabetes, and cardiovascular diseases.❞
You can read the paper in full here: Impact of sleep deprivation on monocyte subclasses and function
What can we do about it?
With regard to sleep, we’ve written so much about this, but here are three key articles that contain a lot of valuable information:
- Get Better Sleep: Beyond The Basics
- Calculate (And Enjoy) The Perfect Night’s Sleep
- Safe Effective Sleep Aids For Seniors
…and with regard to inflammation, a good concise overview of how to dial it down is:
How To Prevent Or Reduce Inflammation
Take care!
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Fitness Walking and Bodyweight Exercises – by Frank S. Ring
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A lot of exercise manuals assume that the reader has a “basic” body (nothing Olympian, but nothing damaged either). As we get older, increasingly few of us fall into the “but nothing damaged either” category!
Here’s where Ring brings to bear his decades of experience as a coach and educator, and also his personal recovery from a serious back injury.
The book covers direct, actionable exercise advice (with all manner of detail), and also offers mental health tips he’s learned along the way.
Ring, like us, is a big fan of keeping things simple, so he focusses on “the core four” of bodyweight exercises:
- Pushups
- Squats
- Lunges
- Planks
These four exercises get a whole chapter devoted to them, though! Because there are ways to make each exercise easier or harder, or have different benefits. For example, adjustments include:
- Body angle
- Points of contact
- Speed
- Pausing
- Range of motion
This, in effect, makes a few square meters of floor (and perhaps a chair or bench) your fully-equipped gym.
As for walking? Ring enjoys and extols the health benefits, and/but also uses his walks a lot for assorted mental exercises, and recommends we try them too.
A fine book for anyone who wants to gain and/or maintain good health, but doesn’t pressingly want to join a gym or start pumping iron!
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