Drug companies pay doctors over A$11 million a year for travel and education. Here’s which specialties received the most
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Drug companies are paying Australian doctors millions of dollars a year to fly to overseas conferences and meetings, give talks to other doctors, and to serve on advisory boards, our research shows.
Our team analysed reports from major drug companies, in the first comprehensive analysis of its kind. We found drug companies paid more than A$33 million to doctors in the three years from late 2019 to late 2022 for these consultancies and expenses.
We know this underestimates how much drug companies pay doctors as it leaves out the most common gift – food and drink – which drug companies in Australia do not declare.
Due to COVID restrictions, the timescale we looked at included periods where doctors were likely to be travelling less and attending fewer in-person medical conferences. So we suspect current levels of drug company funding to be even higher, especially for travel.
What we did and what we found
Since 2019, Medicines Australia, the trade association of the brand-name pharmaceutical industry, has published a centralised database of payments made to individual health professionals. This is the first comprehensive analysis of this database.
We downloaded the data and matched doctors’ names with listings with the Australian Health Practitioner Regulation Agency (Ahpra). We then looked at how many doctors per medical specialty received industry payments and how much companies paid to each specialty.
We found more than two-thirds of rheumatologists received industry payments. Rheumatologists often prescribe expensive new biologic drugs that suppress the immune system. These drugs are responsible for a substantial proportion of drug costs on the Pharmaceutical Benefits Scheme (PBS).
The specialists who received the most funding as a group were cancer doctors (oncology/haematology specialists). They received over $6 million in payments.
This is unsurprising given recently approved, expensive new cancer drugs. Some of these drugs are wonderful treatment advances; others offer minimal improvement in survival or quality of life.
A 2023 study found doctors receiving industry payments were more likely to prescribe cancer treatments of low clinical value.
Our analysis found some doctors with many small payments of a few hundred dollars. There were also instances of large individual payments.
Why does all this matter?
Doctors usually believe drug company promotion does not affect them. But research tells a different story. Industry payments can affect both doctors’ own prescribing decisions and those of their colleagues.
A US study of meals provided to doctors – on average costing less than US$20 – found the more meals a doctor received, the more of the promoted drug they prescribed.
Another study found the more meals a doctor received from manufacturers of opioids (a class of strong painkillers), the more opioids they prescribed. Overprescribing played a key role in the opioid crisis in North America.
Overall, a substantial body of research shows industry funding affects prescribing, including for drugs that are not a first choice because of poor effectiveness, safety or cost-effectiveness.
Then there are doctors who act as “key opinion leaders” for companies. These include paid consultants who give talks to other doctors. An ex-industry employee who recruited doctors for such roles said:
Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations […] If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.
We know about payments to US doctors
The best available evidence on the effects of pharmaceutical industry funding on prescribing comes from the US government-run program called Open Payments.
Since 2013, all drug and device companies must report all payments over US$10 in value in any single year. Payment reports are linked to the promoted products, which allows researchers to compare doctors’ payments with their prescribing patterns.
Analysis of this data, which involves hundreds of thousands of doctors, has indisputably shown promotional payments affect prescribing.
US research also shows that doctors who had studied at medical schools that banned students receiving payments and gifts from drug companies were less likely to prescribe newer and more expensive drugs with limited evidence of benefit over existing drugs.
In general, Australian medical faculties have weak or no restrictions on medical students seeing pharmaceutical sales representatives, receiving gifts, or attending industry-sponsored events during their clinical training. They also have no restrictions on academic staff holding consultancies with manufacturers whose products they feature in their teaching.
So a first step to prevent undue pharmaceutical industry influence on prescribing decisions is to shelter medical students from this influence by having stronger conflict-of-interest policies, such as those mentioned above.
A second is better guidance for individual doctors from professional organisations and regulators on the types of funding that is and is not acceptable. We believe no doctor actively involved in patient care should accept payments from a drug company for talks, international travel or consultancies.
Third, if Medicines Australia is serious about transparency, it should require companies to list all payments – including those for food and drink – and to link health professionals’ names to their Ahpra registration numbers. This is similar to the reporting standard pharmaceutical companies follow in the US and would allow a more complete and clearer picture of what’s happening in Australia.
Patients trust doctors to choose the best available treatments to meet their health needs, based on scientific evidence of safety and effectiveness. They don’t expect marketing to influence that choice.
Barbara Mintzes, Professor, School of Pharmacy and Charles Perkins Centre, University of Sydney and Malcolm Forbes, Consultant psychiatrist and PhD candidate, Deakin University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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The Menopause Risk That Nobody Talks About
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In this week’s health news round up, we cover menopausal disordered eating, air pollution & Alzheimer’s, and cold sore comebacks:
When the body starts changing…
Eating disorders are often thought of as a “teenage girl thing”. But in fact, eating disorders in girls/women mostly occur along with “the three Ps”:
- Puberty
- Pregnancy
- Perimenopause & menopause
In very many cases, it’s likely “my body is changing and I have strong opinions on how it should be”. Those opinions are often reflective of societal norms and pressures, but still, they are earnestly felt also. In the case of pregnancy, the societal pressures and standards are generally lifted while pregnant, but come back immediately postpartum, with an expectation to rebound quickly into the same shape one was in beforehand. And in the case of menopause, this is often concurrent with a sense of loss of identity, and can be quite reactionary against what is generally considered to be the ravages of time.
Of course, looking after one’s health is great at any age, and certainly there is no reason not to pursue health goals and try to get one’s body the way one wants it. However, it is all-too-easy for people to fall into the trap of taking drastic steps that are not actually that healthy, in the hopes of quick results.
Further, 13% of women over 50 report current core eating disorder symptoms, and that is almost certain vastly underreported.
Read in full: Eating disorders don’t just affect teen girls—the risk may also go up around pregnancy and menopause
Related: Body Image Dissatisfaction/Appreciation Across The Ages From Age 16 To Age 88
Where there’s smoke…
It’s been known for a while that air pollution is strongly associated with Alzheimer’s disease incidence, but exactly how this happens has not been entirely clear, beyond that it involves S-nitrosylation, in which NO-related particles bind to sulfur (S) atoms, forming SNO (and scientists being how they are, the term for the resultant brain effect has been called a SNO-STORM).
However, researchers have now found that it has to do with how certain toxins in the air (notwithstanding our heading here, they don’t have to be smoke—it can be household chemicals or other things too) cause this resultant SNO to interfere with protein CRTC1, which is critical for forming/maintaining connections between brain cells.
This is important, because it means that if a drug can be made that selectively blocks S-nitrosylatoin actions affecting CRTC1, it can reverse a lot of Alzheimer’s brain damage (as was found in the laboratory, when testing the theory with CRTC1 proteins that had been genetically engineered to resist S-nitrosylation, which is not something we can do with living human brains yet, but it is “proof of principle” and means funding will likely be forthcoming to find drugs to do the same thing).
Read in full: Study reveals how air pollution contributes to Alzheimer’s disease
Related: 14 Powerful Strategies To Prevent Dementia
The virus that comes back from the cold
Cold sores are created by the Herpes simplex virus (yes, the same one as for the genital variety), and by adulthood, most of us are either infected (and periodically get cold sores), or else infected (as an asymptomatic carrier). A noteworthy minority, but a minority nevertheless, are immune. Unless you’ve never had physical contact with other humans, it’s highly unlikely you’re not in one of the above three categories.
For those who do get cold sores, they can seem random in their reoccurrence, but in reality the virus never went away; it was just dormant for a while.
This much was known already, but scientists have now identified the trigger protein (known as “UL 12.5” to its friends) that acts as an alarm clock for the virus—which may pave the way to a greatly-improved treatment, if a way can be found to safely interfere with that wake-up call:
Read in full: Cold sore discovery identifies unknown trigger for those annoying flare-ups
Related: Beyond Supplements: The Real Immune-Boosters!
Take care!
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28-Day FAST Start Day-by-Day – by Gin Stephens
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We have previously reviewed Gin Stephens’ other book, “Fast. Feast. Repeat.”, so what’s so special about this one that it deserves reviewing too?
This one is all about troubleshooting the pitfalls that many people find when taking up intermittent fasting.
To be clear: the goal here is not a “28 days and yay you did it, put that behind you now”, but rather “28 days and you are now intermittently fasting easily each day and can keep it up without difficulty”. As for the difficulties that may arise early in the 28 days…
Not just issues of willpower, but also the accidental breaks. For example, some artificial sweeteners, while zero-calorie, trigger an insulin response, which breaks the fast on the metabolic level (avoiding that is the whole point of IF). Lots of little tips like that peppered through the book help the reader to stop accidentally self-sabotaging their progress.
The author does talk about psychological issues too, and also how it will feel different at first while the liver is adapting, than later when it has already depleted its glycogen reserves and the body must burn body fat instead. Information like that makes it easier to understand that some initial problems (hunger, getting “hangry”, feeling twitchy, or feeling light-headed) will last only a few weeks and then disappear.
So, understanding things like that makes a big difference too.
The style of the book is simple and clear pop-science, with lots of charts and bullet points and callout-boxes and the like; it makes for very easy reading, and very quick learning of all the salient points, of which there are many.
Bottom line: if you’ve tried intermittent fasting but struggled to make it stick, this book can help you get to where you want to be.
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The Brain-Skin Doctor
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Of Brains And Breakouts
Today’s spotlight is on Dr. Claudia Aguirre. She’s a molecular neuroscientist, and today she’s going to be educating us about skin.
What? Why?
When we say “neuroscience”, we generally think of the brain. And indeed, that’s a very important part of it.
We might think about eyes, which are basically an extension of the brain.
We don’t usually think about skin, which (just like our eyes) is constantly feeding us a lot of information about our surroundings, via a little under three million nerve endings. Guess where the other ends of those nerves lead!
There’s a constant two-way communication going on between our brain and our skin.
What does she want us to know?
Psychodermatology
The brain and the skin talk to each other, and maladies of one can impact the other:
- Directly, e.g. stress prompting skin breakouts (actually this is a several-step process physiologically, but for the sake of brevity we’ll call this direct)
- Indirectly, e.g. nervous disorders that result in people scratching or picking at their skin, which prompts a whole vicious cycle of one thing making the other worse
Read more: Psychodermatology: The Brain-Skin Connection
To address both kinds of problems, clearly something beyond moisturizer is needed!
Mindfulness (meditation and beyond)
Mindfulness is a well-evidenced healthful practice for many reasons, and Dr. Aguirra argues the case for it being good for our skin too.
As she points out,
❝Cultural stress and anxiety can trigger or aggravate many skin conditions—from acne to eczema to herpes, psoriasis, and rosacea.
Conversely, a disfiguring skin condition can trigger stress, anxiety, depression, and even suicide.
Chronic, generalized anxiety can create chronic inflammation and exacerbate inflammatory skin conditions, such as those I mentioned previously.
Chronic stress can result in chronic anxiety, hypervigilance, poor sleep, and a whole cascade of effects resulting in a constant breakdown of tissues and organs, including the skin.❞
So, she recommends mindfulness-based stress reduction (MBSR), for the above reasons, along with others!
Read more: Mind Matters
How to do it: No-Frills, Evidence-Based Mindfulness
And as for “and beyond?”
Do you remember in the beginning of the pandemic, when people were briefly much more consciously trying to avoid touching their faces so much? That, too, is mindfulness. It may have been a stressed and anxious mindfulness for many*, but mindfulness nonetheless.
*which is why “mindfulness-based stress reduction” is not a redundant tautology repeated more than once unnecessarily, one time after another 😉
So: do try to keep aware of what you are doing to your skin, and so far as is reasonably practicable, only do the things that are good for it!
The skin as an endocrine organ
Nerves are not the only messengers in the body; hormones do a lot of our body’s internal communication too. And not just the ones everyone remembers are hormones (e.g. estrogen, testosterone, although yes, they do both have a big impact on skin too), but also many more, including some made in the skin itself!
Dr. Aguirra gives us a rundown of common conditions, the hormones behind them, and what we can do if we don’t want them:
Read more: Rethinking The Skin As An Endocrine Organ
Take-away advice:
For healthy skin, we need to do more than just hydrate, get good sleep, have good nutrition, and get a little sun (but not too much).
- We should also practice mindfulness-based stress reduction, and seek help for more serious mental health issues.
- We should also remember the part our hormones play in our skin, and not just the obvious ones.
Did you know that vitamin D is also a hormone, by the way? It’s not the only hormone at play in your skin by a long way, but it is an important one:
Society for Endocrinology | Vitamin D
Want to know more?
You might like this interview with Dr. Aguirre:
The Brain in Our Skin: An Interview with Dr. Claudia Aguirre
Take care!
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Reduce Your Stroke Risk
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❝Each year in the U.S., over half a million people have a first stroke; however, up to 80% of strokes may be preventable.❞
~ American Stroke Association
Source: New guideline: Preventing a first stroke may be possible with screening, lifestyle changes
So, what should we do?
Some of the risk factors are unavoidable or not usefully avoidable, like genetic predispositions and old age, respectively (i.e. it is possible to avoid old age—by dying young, which is not a good approach).
Some of the risk factors are avoidable. Let’s look at the most obvious first:
You cannot drink to your good health
While overall, the World Health Organization has declared that “the only safe amount of alcohol is zero”, when it comes to stroke risk specifically, it seems that low consumption is not associated with stroke, while moderate to high consumption is associated with a commensurately increased risk of stroke:
Alcohol Intake as a Risk Factor for Acute Stroke
Note: there are some studies out there that say that a low to moderate consumption may decrease the risk compared to zero consumption. However, any such study that this writer has seen has had the methodological flaw of not addressing why those who do not drink alcohol, do not drink it. In many cases, someone who drinks no alcohol at all does so because either a) it would cause problems with some medication(s) they are taking, or b) they used to drink heavily, and quit. In either case, their reasons for not drinking alcohol may themselves be reasons for an increased stroke risk—not the lack of alcohol itself.
Smoke now = stroke later
This one is straightforward; smoking is bad for pretty much everything, and that includes stroke risk, as it’s bad for your heart and brain both, increasing stroke risk by 200–400%:
Smoking and stroke: the more you smoke the more you stroke
So, the advice here of course is: don’t smoke
Diet matters
The American Stroke Association’s guidelines recommend, just for a change, the Mediterranean Diet. This does not mean just whatever is eaten in the Mediterranean region though, and there are specifically foods that are included and excluded, and the ratios matter, so here’s a run-down of what the Mediterranean Diet does and doesn’t include:
The Mediterranean Diet: What Is It Good For? ← what isn’t it good for?!
You can outrun stroke
Or out-walk it; that’s fine too. Most important here is frequency of exercise, more than intensity. So basically, getting those 150 minutes moderate exercise per week as a minimum.
See also: The Doctor Who Wants Us To Exercise Less & Move More
Which is good, because it means we can get a lot of exercise in that doesn’t feel like “having to do” exercise, for example:
Do You Love To Go To The Gym? No? Enjoy These “No-Exercise Exercises”!
Your brain needs downtime too
Your brain (and your heart) both need you to get good regular sleep:
Sleep Disorders in Stroke: An Update on Management
We sometimes say that “what’s good for your heart is good for your brain” (because the heart feeds the brain, and also ultimately clears away detritus), and that’s true here too, so we might also want to prioritize sleep regularity over other factors, even over duration:
How Regularity Of Sleep Can Be Even More Important Than Duration ← this is about adverse cardiovascular events, including ischemic stroke
Keep on top of your blood pressure
High blood pressure is a very modifiable risk factor for stroke. Taking care of the above things will generally take care of this, especially the DASH variation of the Mediterranean diet:
Hypertension: Factors Far More Relevant Than Salt
However, it’s still important to actually check your blood pressure regularly, because sometimes an unexpected extra factor can pop up for no obvious reason. As a bonus, you can do this improved version of the usual blood pressure test, still using just a blood pressure cuff:
Try This At Home: ABI Test For Clogged Arteries
Consider GLP-1 receptor agonists (or…)
GLP-1 receptor agonists (like Ozempic et al.) seem to have cardioprotective and neuroprotective (thus: anti-stroke) activity independent of their weight loss benefits:
Of course, GLP-1 RAs aren’t everyone’s cup of tea, and they do have their downsides (including availability, cost, and the fact benefits reverse themselves if you stop taking them), so if you want a similar effect from a natural approach, there are some foods that work on the body’s incretin responses in the same way as GLP-1 RAs do:
5 Foods That Naturally Mimic The “Ozempic Effect”
Better to know sooner rather than too late
Rather than waiting until one half of our face is drooping to know that there was a stroke risk, here are things to watch out for to know about it before it’s too late:
6 Signs Of Stroke (One Month In Advance)
Take care!
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Leek vs Scallions – Which is Healthier?
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Our Verdict
When comparing leek to scallions, we picked the leek.
Why?
In terms of macros, scallions might have a point: scallions have the lower glycemic index, thanks to leek having more carbs for the same amount of fiber. That said, leek already has a low glycemic index, so this is not a big deal.
When it comes to vitamins, leek has more of vitamins B1, B2, B3, B5, B6, B9, E, and choline, while scallions have more of vitamins A, C, and K. Noteworthily, a cup of chopped leek already provides the daily dose of vitamins A and K, and the difference in levels of vitamin C is minimal. All in all, an easy 8:3 win for leeks here, even without taking that into account.
In the category of minerals, leek has more calcium, copper, iron, magnesium, manganese, phosphorus, potassium, and selenium, while scallions have a little more zinc.
Both of these allium-family plants (i.e., related to garlic) have an abundance of polyphenols, especially kaempferol.
Of course, enjoy whatever goes best with your meal, but if you’re looking for nutritional density, then leek is where it’s at.
Want to learn more?
You might like to read:
The Many Health Benefits Of Garlic
Take care!
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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.
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