Insulin Pumps and the World Traveler - Public Service Announcement

More and more people are becoming diabetic, and consequently more people are ending up using insulin pumps.  The technology is now fantastic and even type 1 diabetics whose sugars have been all over the place are now controlled.  But those people have realized that traveling wreaks havoc with glucose control.  Now we know why – BUBBLES!  For most people it’s not a big deal, but for some, it can be.  

Please forward this to anyone you know who uses an insulin pump.  They’ll find it useful.

FROM MEDSCAPE / BY MIRIAM E. TUCKER

Air Travel Alters Insulin Pump Delivery on Takeoff, Landing

MADRID — Airplane travel consistently causes insulin pumps to over-deliver a little over half a unit on takeoff and under-deliver a bit less on landing, new research found.

This phenomenon is due to air bubble formation and reabsorption in the insulin caused by ambient pressure changes in the airplane's cabin. It has nothing to do with the pump itself and happens with all insulin pumps, including those in hybrid closed-loop systems, Bruce King, MD, said at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The extent to which this affects people with diabetes who use insulin pumps depends on their dose and insulin sensitivity among other factors, but all who fly should be aware of the possibility and take precautions, particularly with children, King, a pediatric endocrinologist at John Hunter Children's Hospital, Newcastle, Australia, told Medscape Medical News.

"Basically, the pumps are very safe in flight, but they deliver a little bit of extra insulin when you go up and stop delivery when you come back down again. There are a couple of simple steps that people can take to make sure that they don't have problems during the flight," he said.

Specifically, he advised that for pumps with tubing, wearers can disconnect just prior to takeoff and reconnect when the plane reaches cruising altitude, about 20 minutes into the flight. The insulin will still come out, but it won't be delivered to the person, King said.

On descent, they can disconnect after landing and prime the line to remove the insulin deficit.

With the Omnipod, which can't be disconnected, the only solution is to eat a small snack on takeoff. And on landing, eat another small snack such as a banana, and give a bolus for it to overcome the blockage of insulin delivery.

In any case, King said, "One of the most important things is informing people with diabetes about this effect so they're aware of it and can act appropriately when they fly."

Asked to comment, Nicholas B. Argento, MD, a practicing endocrinologist in Columbia, Maryland, and author of the American Diabetes Association's book Putting Your Patients on the Pump, called the issue a "minor effect," adding, "While I think it would be reasonable to make those changes…it seems like a lot of effort for a difference of 0.6 units extra on ascent and 0.5 units less on descent."

He noted there is a risk that the individual might forget to reattach the pump after 20 minutes, leading to hyperglycemia and even diabetic ketoacidosis. Instead, "one could put the pump on suspend for 1 hour on ascent. That would not stop the extra insulin but would net less insulin during that time period."

And after descent, "you have to walk a lot in most cases, so I don't think they need to take this into consideration. So many other factors change in air travel that I don't think this is a significant enough effect to make the effort."

A Known Phenomenon, the Manufacturers Are Aware

This phenomenon has been described previously, including by King in a 2011 Diabetes Care paper. The new research is among a series of experiments funded by the European Union Aviation Safety Agency in collaboration with the pump manufacturers Medtronic (MiniMed), Tandem (t:slim), and Insulet (Omnipod), primarily aimed at establishing safety parameters for airline pilots with insulin-treated diabetes.

Both the Omnipod DASH and Omnipod 5 User Guides include warnings about unintended insulin delivery during flight, and both advise users to check their blood glucose levels frequently while flying.

In a statement, Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care, told Medscape Medical News, "While it has long been known that routine air travel pressure changes can cause minor fluctuations in insulin pump delivery, the impact of these variations have been found to be generally minor as it relates to glycemic control."

Pinsker added that the Tandem Mobi user manual includes a warning related to significant pressure changes in specific air travel situations and offers guidance to disconnect. However, "the t:slim X2 pump's microdelivery technology limits how much extra insulin can get delivered from air pressure changes due to a mechanism between the tubing and the contents of the bag inside the cartridge."

Medtronic's user guide says that the 780G system has not been tested at altitudes higher than 10,150 feet.

Hypobaric Chamber Used to Simulate Flight

The study was conducted in vitro, in a hypobaric chamber designed to mimic atmospheric changes during commercial flight. A total of 10 Medtronic MiniMed 780G, 10 Tandem t:slim X2, and six Insulet Omnipod DASH pumps were tested.

The hypobaric chamber was depressurized to 550 mm Hg over a 20-minute ascent, maintained at a 30-minute cruise, followed by a 20-minute descent to ground (750 mm Hg). During the simulated flights, insulin infusion was set at 0.6 units per hour, a rate typical for both adults and children, to allow accurate measurements with multiple flights.

Insulin delivery rates and bubble formation were recorded by attaching infusion sets to open-ended 100 µL capillary tubes against 1-mm grid paper.

Full cartridges — Medtronic: 3 mL, t:slim: 3 mL, and Omnipod: 2 mL — all over-delivered 0.60 units of insulin over a 20-minute ascent compared with delivery at ground level. And during descent, the cartridges under-delivered 0.51 units of insulin.

But if There's Rapid Decompression…

In a separate protocol, insulin infusion sets without pumps were tested in a simulation of rapid decompression. Insulin delivery during both ascent and descent showed statistically significant differences compared with delivery at ground level (both P < .001). In this scenario, fluid delivery was equivalent to 5.6 units of excess insulin.

King pointed out that while these are rare events, about 40-50 occur annually. One was the widely publicized Alaska Airlines flight in January 2024 when the door fell off in midair.

Argento commented, "The catastrophic decompression is of note, and I would want patients to be aware of this, but it is asking a lot for someone thinking they are going to die to remember to disconnect as it starts."

The researchers are investigating this phenomenon further in people, including airline pilots.

Source: https://www.medscape.com/viewarticle/air-t...

Depression and Ice Cream

Headlines often conflate associations into causation, essentially as click-bait.  What does that mean?  

My favorite example is “Ice Cream Causes Drowning”.  No – I don’t mean the kids went swimming too soon after eating (that’s a myth, too, by the way).  Drowning increases when more people go swimming.  More people go swimming when it’s hot; more people eat ice cream when it’s hot, ergo – ice cream causes drowning.  Duh --- NO!  Association is not causation.

Here we have more steps equals less depression.  But how do we know that the more depressed on is, the less likely they are to walk lots of steps?  Meta-analyses group together lots of studies that may look at different questions, but have data that can be examined from a different angle.  Opportunities to point to causation is extremely limited.  Most of the articles these days are in this category, so be careful in the conclusions you draw.

What can we say?  If you walk more, you’re less likely to be depressed.  Does walking more decrease depressive symptoms?  The answer to that is YES – just not from this meta-analysis.

FROM MEDSCAPE / BY ANUSHREE CHAPHALKAR

Can Walking More Steps Per Day Help Keep Depression Away?

TOPLINE:

Walking 7000 or more steps per day is associated with fewer depressive symptoms and a 31% lower risk for depression than taking fewer steps, a new meta-analysis shows.

METHODOLOGY:

  • Researchers conducted a systematic review and meta-analysis of 33 observational studies that included more than 96,000 adults aged 18-91 years.

  • Data were obtained from 27 cross-sectional and 6 longitudinal studies and from 5 major databases through May 2024.

  • Objectively measured daily step counts and depression data were collected via various assessment tools.

TAKEAWAY:

  • The number of daily steps had a significant inverse correlation with depressive symptoms in both cross-sectional (correlation coefficient [r], −0.12; 95% CI, −0.20 to −0.04) and panel studies (r, −0.17; 95% CI, −0.28 to −0.04).

  • Participants achieving 7000 steps per day or more showed a lower risk for depression than those achieving less than 7000 steps per day (risk ratio [RR], 0.69; 95% CI, 0.62-0.77).

  • An additional increase of 1000 steps per day was associated with a 9% lower risk for depression (RR, 0.91; 95% CI, 0.87-0.94).

  • Cross-sectional analysis showed that, compared with walking less than 5000 steps per day, walking 5000-7499 steps per day, 7500-9999 steps per day, and at least 10,000 steps per day were all significantly associated with fewer depressive symptoms (standardized mean difference, −0.17, −0.27, and −0.26, respectively).

IN PRACTICE:

"The objective measurement of daily steps may represent an inclusive and comprehensive approach to public health that has the potential to prevent depression. Small amounts of PA [physical activity] may be particularly relevant for specific populations, such as older adults and individuals with limited activities of daily living, for whom daily steps emerge as an accessible PA strategy," the investigators wrote.

SOURCE:

The study was led by Bruno Bizzozero-Peroni, PhD, Health and Social Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain. It was published online December 16 in JAMA Network Open.

LIMITATIONS:

Reverse associations were possible, and causal inferences could not be made from the findings. In addition, the analysis showed substantial between-study heterogeneity in some pooled estimates, partially explained by differences in participant characteristics and step-counting devices. Most studies also lacked robust methods, potentially affecting result reliability, and the meta-analysis comparing high vs low daily step counts may have been susceptible to publication bias.

DISCLOSURES:

The study was funded by the University of Castilla-La Mancha, National Agency for Research and Innovation, Ministry of Economy and Competitiveness of Spain, Carlos III Health Institute, European Regional Development Fund, and European Union's Next Generation EU initiative. No conflicts of interest were reported.

Source: https://www.medscape.com/viewarticle/can-w...

Women WIN -- when it comes to a Little Exercise

Surprise – we’re talking about exercise again!

And the good news only applies to women, and we don’t know why, but we think it’s related to intensity.

Anyway – If women can get even less than 2 minutes of vigorous exercise a day had a reduction in MACE (major adverse cardiovascular events), heart attack and heart failure.  As the vigorous exercise went up, the rate of events went down.  For men the benefits were not statistically significant (men didn’t get their heart rate up as high with their activity seems to be the reason). 

So, again, time to get moving.  But you have to work hard – for 20 or 30 seconds at a time, a few times a day – is that so bad?  Come on!  Let’s go!

FROM MEDSCAPE / BY CAROLYN BROWN

Just Minutes of Daily Vigorous Exercise Improve Heart Health

Middle-aged women who did many short bursts of vigorous-intensity exercise — amounting to as little as 3 min/d — had a 45% lower risk for major adverse cardiovascular events, reported investigators.

This doesn’t mean just a walk in the park, explained Emmanuel Stamatakis, PhD, a researcher with the University of Sydney in Sydney, Australia. He said the activity can be as short as 20-30 seconds, but it must be high intensity — “movement that gets us out of breath, gets our heart rate up” — and repeated several times daily.

Stamatakis and his colleagues call this type of exercise vigorous intermittent lifestyle physical activity, and it involves intense movement in very short bouts that are part of daily life, like a quick stair climb or running for a bus.

In their study, published in the British Journal of Sports Medicine, most exercise bursts were less than a minute, and few were over 2 minutes.

This is the third study in which the international network of researchers has shown the health benefits of vigorous physical activity. They are upending the common view that “any physical activity under 10 minutes doesn’t count for health,” said Stamatakis.

Bursts of Energy

The three studies looked at data for thousands of middle-aged men and women aged 40-69 years collected in the UK Biobank. Their daily activity was measured using accelerometers worn on the wrist for 7 days. This is preferable to survey data, which Stamatakis said is often unreliable.

The analysis looked at people who reported that they did not do any other exercise, taking no more than a single walk during the week. Then their cardiovascular health was tracked for almost 8 years.

Previous studies of the same data have shown benefits of vigorous physical activity for risk for cancer and for risk for death, both overall and due to cardiovascular disease or cancer.

In this study, women who did even less than 2 minutes of vigorous physical activity a day but no other exercise had a lower risk for all major cardiovascular events and for heart attack and heart failure. Women who did the median daily vigorous exercise time — 3.4 minutes — had an even lower risk. In fact, in women, there was a direct relationship between daily exercise time and risk reduction.

In men, the study showed some benefit of vigorous physical activity, but the relationship was not as clear, said Stamatakis. “The effects were much subtler and, in most cases, did not reach statistical significance.”

Good News for Women

Stamatakis said it is unclear why there was such a gap in the benefits between men and women. “Studies like ours are not designed to explain the difference,” he added.

“This study does not show that [vigorous physical activity] is effective in women but not men,” said Yasina Somani, PhD, an exercise physiology researcher at the University of Leeds, Leeds, England, who was not involved in the work. Because the study just observed people’s behavior, rather than studying people in controlled conditions such as a lab, she said you cannot reach conclusions about the benefits for men. “You still need some further research.”

Somani pointed out that a study like this one cannot determine how vigorous physical activity protects the heart. In her research, she has studied the ways that exercise exerts effects on the heart. Exercise stresses the cardiovascular system, leading to physiological adaptation, and this may differ between men and women.

“Seeing this article motivates me to understand why women are responding even more than men. Do men need a greater volume of this exercise? If you’re carrying a 10-pound grocery bag up a flight of stairs, who is getting the greater stimulus?”

In fact, the study researchers think women’s exercise bursts might simply be harder for them. For some of the sample, the researchers had data on maximal oxygen consumption (VO2 max), a measure of cardiovascular fitness. During vigorous physical activity bouts, this measure showed that the effort for women averaged 83.2% of VO2 max, whereas it was 70.5% for men.

Somani said, “For men, there needs to be more clarity and more understanding of what it is that provides that stimulus — the intensity, the mode of exercise.”

“People are very surprised that 20-30 seconds of high-intensity exercise several times a day can make a difference to their health,” said Stamatakis. “They think they need to do structured exercise,” such as at a gym, to benefit.

He said the message that even quick exercise hits are beneficial can help healthcare professionals foster preventive behavior. “Any health professional who deals with patients on a regular basis knows that physical activity is important for people’s overall well-being and prevention of chronic disease.” The difficulty is that many people cannot or simply do not exercise. “Some people cannot afford it, and some do not have the motivation to stick to a structured exercise program.”

But anyone can do vigorous physical activity, he said. “The entry level is very low. There are no special preparations, no special clothes, no money to spend, no time commitment. You are interspersing exercise across your day.”

The researchers are currently studying how to foster vigorous physical activity in everyday behavior. “We are codesigning programs with participants, engaging with middle-aged people who have never exercised, so that the program has the highest chance to be successful.” Stamatakis is looking at encouraging vigorous physical activity through wearable devices and coaching, including online options.

Somani said the study adds weight to the message that any exercise is worthwhile. “These are simple choices that you can make that don’t require engaging in more structured exercise. Whatever you can do — little things outside of a gym — can have a lot of benefit for you.”

Source: https://www.medscape.com/viewarticle/just-...

Another Chocolate Story -- it's back to Dark!

Wait long enough, and there will be another study on chocolate to talk about.  This time is back to Dark as the winner!  Studies go back and forth – it’s pretty much always good news –chocolate lowers mortality, certain diseases, etc, but while dark seems to always benefit, milk doesn’t always.  Well, it’s like that again today.

Eating dark chocolate 5 or more servings a week drops the risk of type 2 diabetes by 21%, where eating milk chocolate doesn’t do anything – well, not entirely true.  Eating more milk chocolate IS associated with weight gain!  Milk chocolate actually has more sugar than cocoa, and, as a consequence, has less of the good stuff (flavanols).  

Of course it’s never that simple – intake of dark chocolate also coincides with better food choices… so is it really the chocolate?

FROM MEDPAGE TODAY / BY SOPHIE PUTKA

New Study Teases Out Chocolate and Diabetes Connection

— Eating more dark chocolate was associated with a lower risk of type 2 diabetes

Eating more dark chocolate was associated with a lower risk of type 2 diabetes, an analysis of prospective cohort studies suggested.

Among participants across three studies of healthcare workers, those who consumed ≥5 servings per week of dark chocolate had a 21% lower risk of type 2 diabetes compared with those who never or rarely consumed dark chocolate (P=0.006 for trend), reported Qi Sun, MD, ScD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in The BMJ.

There was no significant association between consumption of milk chocolate and type 2 diabetes, but intake of milk chocolate was positively associated with weight gain, while this was not the case for dark chocolate.

"We were surprised to see a stark contrast between dark and milk chocolate," co-author Binkai Liu, MS, also of Harvard T.H. Chan School of Public Health, told MedPage Today. "While dark chocolate was associated with a lower risk of type 2 diabetes, milk chocolate showed no such benefit and was even associated with weight gain. This difference underscores the importance of chocolate type and its nutrient composition."

"Advising patients to enjoy dark chocolate occasionally as part of a balanced and nutrient-rich diet could be a way to integrate these insights into practical recommendations," she added.

Chocolate is high in polyphenols, including flavanols (part of the larger flavonoid group), and previous studies have shown an association between higher dietary flavonoid consumption and decreased type 2 diabetes risk.

Though flavonoids may confer antioxidant, anti-inflammatory, and vasodilatory benefits, the relationship between chocolate consumption and diabetes remains "controversial," the authors wrote, due to observational studies with inconsistent findings, and a lack of inquiry into health effects by chocolate subtype.

"We made efforts to adjust for various dietary, lifestyle, and socioeconomic variables, but residual confounding remains a possibility," Liu said.

Simin Liu, MD, ScD, of the University of California Irvine, who was not involved in the study, told MedPage Today that "the new findings, while promising, should be interpreted with caution. Observational studies like this can show associations but cannot definitively prove cause and effect."

"It's plausible that the flavanols in dark chocolate may contribute to improved insulin sensitivity and glucose metabolism, which could offer some protection against type 2 diabetes," he noted. "However, it's important to consider other lifestyle factors that may be influencing the results."

For this analysis, Sun and team used data from the Nurses' Health Study (NHS) and the Nurses' Health Study II (NHSII) (both all female), as well as the Health Professionals Follow-up Study (HPFS; all male). Total chocolate consumption baselines for the NHS and HPFS were in 1986, and in 1991 for the NHSII, when comprehensive food frequency questionnaires were first implemented. The second baseline, for chocolate subtype analyses, were in 2006 for the NHS and HPFS and 2007 for the NHSII, when the survey added questions about chocolate types.

Participants' diets were assessed every 4 years, with questions about average consumption of a standard portion size of chocolate in the past year, with nine frequency levels ("never, or less than once per month" to "≥6 per day"). Starting in later years, participants were asked, "How often do you consume milk chocolate (bar or pack)?" and "How often do you consume dark chocolate?"

Other variables assessed included race/ethnicity, body weight, waist circumference, smoking status, alcohol consumption, multivitamin use, menopausal status and postmenopausal hormone use, oral contraceptive use, hypertension, hypercholesterolemia, and family history of diabetes. Physical activity and body mass index were measured over time. Diabetes was self-reported in biennial questionnaires and confirmed by study doctors with a supplementary questionnaire, which collected more details about diagnoses and treatment.

In total, 192,208 participants were included from the three trials in the total chocolate intake analysis, with 111,654 included in the analysis on chocolate types. The mean ages at first baseline were 52.3, 36.1, and 53.1 for the NHS, NHSII, and HPFS, respectively. For baseline 2, they were 70.4, 52.3, and 68.3, respectively. Most participants were non-Hispanic white.

In the analysis on total chocolate intake, participants who consumed ≥5 servings per week of any chocolate had a 10% lower relative risk of type 2 diabetes compared with those who never or rarely consumed chocolate, but this was not a significant trend (P=0.07).

Participants with higher chocolate intake had higher energy, saturated fat, and added sugar intakes. Higher levels of dark chocolate consumption were associated with higher-quality diet, as assessed by the Alternate Healthy Eating Index-2010 (based on food frequency questionnaire responses), and greater consumption of fruit and vegetables, epicatechin, and total flavonoids. The opposite was true for milk chocolate consumption.

The authors were limited by potential confounding, and a limited number of people with type 2 diabetes in the higher chocolate consumption groups. Most of the participants in the chocolate subtype analyses were white adults over 50 at baseline, which could limit the generalizability of the findings to other populations.

Moreover, chocolate consumption in the overall study population was low compared with the national average, which was another limitation.

Source: https://www.medpagetoday.com/endocrinology...

Pooping makes you Faster...and Smarter!

Recently there’s been a lot of talk about a gut-brain connection, but is this taking things a little too far?

Turns out, no, there’s actually data supporting the idea that not only are the bowels and the brain connected, but if you want to be faster and smarter – use the toilet!

If you empty your bowels prior to a triathlon, you’ll perform better.  In this case, they gave athletes a magnesium oxide laxative to ensure “performance” prior to the race.  Each one also improved they race “performance” and cognitive test result.  Even 69% of the athletes who did not get the laxative saw Stroop test improvement, confirming the rectal-brain connection.  

I’m sure there’s a joke in there, but I just can’t seem to….oh, never mind.

FROM SCIENCE ALERT / BY MICHELLE STARR

Pooping Before You Exercise Has an Incredible Effect on Performance

If you're looking to improve your performance, both cognitively and physically, you need to start by giving a crap.

No, quite literally. Go to the toilet and empty your bowel. If you're about to compete in a triathlon, it will make you both faster and smarter, according to two recent studies.

The latest research involved 13 triathletes, a cognitive test called the Stroop test, and a magnesium oxide laxative.

The result? The athletes performed measurably better on the cognitive test after voiding their large intestines, a finding that suggests an underexplored link between the rectum and cognitive function. This potential link has interesting implications, not just for peak performance, but for understanding cognitive decline.

"The most striking finding of this study is the unequivocal improvement observed in Stroop test performance for all participants consuming magnesium oxide," writes a team of researchers led by biochemist Chen-Chan Wei of the University of Taipei in a new paper.

"Even in the absence of magnesium oxide, defecation led to improved Stroop test results for 9 out of 13 individuals."

A Stroop test is one that presents you with a visual of conflicting information. The word "red" might appear in blue text, for example; the test participant needs to say aloud the color of the text, not the color word that is written. It evaluates cognitive flexibility and response time.

A 2022 study found that patients with early-stage Parkinson's disease can exhibit mild cognitive impairment when constipated, suggesting a link between the rectum and the brain. Such a concept isn't without precedent. Your gut contains hundreds of millions of neurons, and the gut microbiome may play a role in your mood, as well as neurological and mental health disorders.

Wei and colleagues wanted to investigate the link for athletes. Triathlons, involving three different sports disciplines, are taxing on both mind and body. The athlete needs to make fast decisions to navigate the course, have the fortitude to last the distance, and in the process try to best their fellow athletes.

The researchers previously showed that having a poop before getting on a bike resulted in improved performance – and improved blood flow in the prefrontal cortex region of the brain – in triathletes. The next step, after establishing a link between an empty bowel and increased physical performance, was to try to identify if there was a similar link to cognitive performance.

"When you do exercise, especially long-distance exercise, your brain is going to be sending high amounts of commands to the muscles," explains physiologist Chia-Hua Kuo of the University of Taipei.

"Whether or not you can sustain muscle contraction is not really depending on whether your muscle has wrung out the energy, it's whether your brain is able to challenge your muscle."

Each of the 13 triathletes in the study participated in three sessions of Stroop testing. For the first session, the test was taken without a prior bowel movement. For the second session, after a careful diet, the test was administered an hour after a bowel movement. Finally, for the third session, the athletes were given magnesium oxide; they took the test 13 hours after taking the laxative, and an hour after defecation.

More than two thirds of participants performed better on the test with empty bowels in the second session. Intriguingly, 100 percent saw improvement after a laxative-aided defecation.

Although the sample size was small, the difference in performance between the sessions suggests that emptying one's bowels could be linked to improved cognition.

The link and the reasons for it have not been definitively established, but the researchers believe that it may have something to do with finite resources in the body. When you have material in your digestive tract, blood and oxygen are used to help break it down. With no material to digest, those resources can be used elsewhere.

Near-infrared spectroscopy images highlighting real-time oxygenation and blood distribution. Arrows indicate the position of spectroscopy detector probes. (Wei et al., SMHS, 2024)

In fact, insufficient resourcing during exercising is thought to be the cause of the well-known phenomenon of runners' diarrhea, in which athletes lose control of their bowels while engaged in intense exercise.

In a 2012 review, scientists found that "During physical exercise, the increased activity of the sympathetic nervous system redistributes blood flow from the splanchnic organs to the working muscles… A severely reduced splanchnic blood flow may frequently cause gastrointestinal ischemia."

That means that the body redirects blood away from the gastrointestinal organs to work on the exercise; and the reduced blood flow causes gastrointestinal pyrotechnics.

It's all connected in strange and wonderful ways. Or, as Kuo puts it: "Our spirit is not only inside the skull, but also in other parts. And the rectum is also part of the brain."

The researchers caution against taking laxative drugs. If you are having issues maintaining gastrointestinal regularity, seek help from a medical professional.

The findings have been published in Sports Medicine and Health Science.

Source: https://www.sciencealert.com/pooping-befor...

"There's a great future in plastics"... In Us?!?

In 1967, “The Graduate” reported that there was a great future in plastics.  I doubt they meant that the future of plastics was “in us”.  But that’s what it’s looking like.  Back several years ago there was an article that said people were eating the equivalent of a credit card in microplastics every week.  Turns out that was wrong – we only eat a credit card every year.  But it never goes away….

Those microplastics range from 5 ½ microns up to 26 microns (a human hair averages around 70 microns) and have now been found in the olfactory bulb (your nose smell center – part of your brain).

But it’s not just them being there – we can’t break them down and excrete them – they can degrade and potentially spread through the body and, since those substance are known to be toxic, potentially make who knows what kind of mess!  

The real question I ask is not IF you are toxic, but rather, how TOXIC are you?  If you have stuff that doesn’t fit the usual scenarios, this might be the very question you need to answer.

FROM MEDSCAPE / by Deborah Brauser

Microplastics Have Been Found in the Human Brain. Now What?

Microplastics have been found in the lungs, liver, blood, and heart. Now, researchers report they have found the first evidence of the substances in human brains.

In a recent case series study that examined olfactory bulb tissue from deceased individuals, 8 of the 15 decedent brains showed the presence of microplastics, most commonly polypropylene, a plastic typically used in food packaging and water bottles.

Measuring less than 5 mm in size, microplastics are formed over time as plastic materials break down but don’t biodegrade. Exposure to these substances can come through food, air, and skin absorption.

While scientists are learning more about how these substances are absorbed by the body, questions remain about how much exposure is safe, what effect — if any — microplastics could have on brain function, and what clinicians should tell their patients.

What Are the Major Health Concerns?

The Plastic Health Council estimates that more than 500 million metric tons of plastic are produced worldwide each year. In addition, it reports that plastic products can contain more than 16,000 chemicals, about a quarter of which have been found to be hazardous to human health and the environment. Microplastics and nanoplastics can enter the body through the air, in food, or absorption through the skin.

As previously reported by Medscape Medical News, a study published in March showed that patients with carotid plaques and the presence of microplastics and nanoplastics were at an increased risk for death or major cardiovascular events.

Other studies have shown a link between these substances and placental inflammation and preterm births, reduced male fertility, and endocrine disruption — as well as accelerated spread of cancer cells in the gut.

There is also evidence suggesting that microplastics may facilitate the development of antibiotic resistance in bacteria and could contribute to the rise in food allergies.

And now, Thais Mauad, MD, PhD, and colleagues have found the substances in the brain.

How Is the Brain Affected?

The investigators examined olfactory bulb tissues from 15 deceased Sao Paulo, Brazil, residents ranging in age from 33 to 100 years who underwent routine coroner autopsies. All but three of the participants were men.

Exclusion criteria included having undergone previous neurosurgical interventions. The tissues were analyzed using micro–Fourier transform infrared spectroscopy (µFTIR).

In addition, the researchers practiced a “plastic-free approach” in their analysis, which included using filters and covering glassware and samples with aluminum foil.

Study findings showed microplastics in 8 of the 15 participants — including in the centenarian. In total, there were 16 synthetic polymer particles and fibers detected, with up to four microplastics detected per olfactory bulb. Polypropylene was the most common polymer found (44%), followed by polyamide, nylon, and polyethylene vinyl acetate. These substances are commonly used in a wide range of products, including food packaging, textiles, kitchen utensils, medical devices, and adhesives.

The microplastic particles ranged in length from 5.5 to 26 microns (one millionth of a meter), with a width that ranged from 3 to 25 microns. The mean fiber length and width was 21 and 4 microns, respectively. For comparison, the diameter of one human hair averages about 70 microns, according to the US Food and Drug Administration (FDA).

“To our knowledge, this is the first study in which the presence of microplastics in the human brain was identified and characterized using µFTIR,” the researchers wrote.

How Do Microplastics Reach the Brain?

Although the possibility of microplastics crossing the blood-brain barrier has been questioned, senior investigator Mauad, associate professor in the Department of Pathology, the University of Sao Paulo, Sao Paulo, Brazil, noted that the olfactory pathway could offer an entry route through inhalation of the particles.

This means that “breathing within indoor environments could be a major source of plastic pollution in the brain,” she said in a press release.

“With much smaller nanoplastics entering the body with greater ease, the total level of plastic particles may be much higher. What is worrying is the capacity of such particles to be internalized by cells and alter how our bodies function,” she added.

Mauad told Medscape Medical News that although questions remain regarding the health implications of their findings, some animal studies have shown that the presence of microplastics in the brain is linked to neurotoxic effects, including oxidative stress.

In addition, exposure to particulate matter has been linked previously to such neurologic conditions as dementia and neurodegenerative conditions such as Parkinson’s disease “seem to have a connection with nasal abnormalities as initial symptoms,” the investigators noted.

While the olfactory pathway appears to be a likely route of exposure the researchers noted that other potential entry routes, including through blood circulation, may also be involved.

The research suggests that inhaling microplastics while indoors may be unavoidable, Mauad said, making it unlikely individuals can eliminate exposure to these substances.

“Everything that surrounds us is plastic. So we can’t really get rid of it,” she said.

Are Microplastics Regulated?

The most effective solution would be stricter regulations, Mauad said.

“The industry has chosen to sell many things in plastic, and I think this has to change. We need more policies to decrease plastic production — especially single-use plastic,” she said.

Federal, state, and local regulations for microplastics are “virtually nonexistent,” reported the Interstate Technology and Regulatory Council (ITRC), a state-led coalition that produces documents and trainings related to regulatory issues.

In 2021, the ITRC sent a survey to all US states asking about microplastics regulations. Of the 26 states that responded, only four said they had conducted sampling for microplastics. None of the responders indicated they had established any criteria or standards for microplastics, although eight states indicated they had plans to pursue them in the future.

Although federal regulations include the Microbead-Free Waters Act of 2015 and the Save Our Seas Act 2.0, the rules don’t directly pertain to microplastics.

There are also no regulations currently in place regarding microplastics or nanoplastics in food. A report issued in July by the FDA claimed that “the overall scientific evidence does not demonstrate that levels of microplastics or nanoplastics found in foods pose a risk to human health.”

International efforts to regulate microplastics are much further along. First created in 2022, the treaty would forge an international, legally binding agreement.

While it is a step in the right direction, the Plastic Health Council has cautioned about “the omission of measures in draft provisions that fully address the impact of plastic pollution on human health.” The treaty should reduce plastic production, eliminate single-use plastic items, and call for testing of all chemicals in plastics, the council argues.

The final round of negotiations for the UN Global Plastic Treaty is set for completion before the end of the year.

What Should Clinicians Know?

Much remains unknown about the potential health effects of microplastic exposure. So how can clinicians respond to questions from concerned patients?

“We don’t yet have enough evidence about the plastic particle itself, like those highlighted in the current study — and even more so when it comes to nanoplastics, which are a thousand times smaller,” Phoebe Stapleton, PhD, associated professor in the Department of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy at Rutgers University, Piscataway, New Jersey, told Medscape Medical News.

“But we do have a lot of evidence about the chemicals that are used to make plastics, and we’ve already seen regulation there from the EPA. That’s one conversation that clinicians could have with patients: about those chemicals,” she added.

Stapleton recommended clinicians stay current on the latest research and be ready to respond should a patient raise the issue. She also noted the importance of exercising caution when interpreting these new findings.

While the study is important — especially because it highlights inhalation as a viable route of entry — exposure through the olfactory area is still just a theory and hasn’t yet been fully proven.

In addition, Stapleton wonders whether there are tissues where these substances are not found. A discovery like that “would be really exciting because that means that that tissue has mechanisms protecting it, and maybe, we could learn more about how to keep microplastics out,” she said.

She would also like to see more studies on specific adverse health effects from microplastics in the body.

Mauad agreed.

“That’s the next set of questions: What are the toxicities or lack thereof in those tissues? That will give us more information as it pertains to human health. It doesn’t feel good to know they’re in our tissues, but we still don’t have a real understanding of what they’re doing when they’re there,” she said.

Source: https://www.medscape.com/viewarticle/micro...

Does your Heart have a "Brain"?

Never to be one that stays in my lane, here’s some obscurity that is not only interesting, but may have real implications down the road.

There’s lots of evidence that says the heart is the heart of everything – that’s why we call it the heart!  Discussions of interactions between heart and brain are fascinating – like why are there many more signals going from the heart to the brain than the other way around?  Is the heart in charge or the brain? 

A  “mini-brain” has been confirmed in the heart of a zebrafish (why a zebrafish?  Turns out it’s closer to a human heart than a mouse heart), and unlike what was previously believed, it functions independently from the brain.  This complex mini-brain can independently effect heart rate, but it’s more than that -- zebrafish neurons are known to produce substances that activate stem cells in bones, skin, and even the nervous system.  How will this information shake out?

Who knows – but I think it’s pretty cool! 

FROM MEDSCAPE / BY Tatum Anderson

The heart’s “mini-brain” is independent and highly localized, according to researchers at the Karolinska Institutet in Stockholm, Sweden. The findings could lead to new research into arrhythmia, dementia, and Parkinson’s disease.

Although controlled by the brain, the heart has a separate, smaller intracardiac nervous system (IcNS) embedded within the superficial layers of the heart wall. Nicknamed the mini-brain by researchers decades ago, the IcNS was assumed to be a simple structure capable only of relaying simple information from the brain to the heart.

The neurons in the mini-brain, however, have been under-researched, said Konstantinos Ampatzis, principal researcher and assistant professor of neuroscience at the Karolinska Institutet. “Cardiologists know that neurons exist but never study them because their first concern is the cardiac muscle cells, or cardiomyocytes, that are responsible for the heartbeat,” he explained. “Neuroscientists understand and decode neurons but don’t know about neurons in the heart.”

Ampatzis’s team mapped the exact composition, organization, and function of neurons in the IcNS using zebrafish as an animal model. “The heart of the zebrafish is closer to that of humans than the mouse heart is,” he explained. “The heart rate of a zebrafish is exactly the same.”

Several techniques were used to characterize these neurons. Electrophysiology determined their function, and researchers at Columbia University in New York City helped identify their molecular signatures using single-cell RNA sequencing. Ampatzis and his team also analyzed neurotransmitters that the neurons release to communicate with each other. Researchers in Sweden and New York worked on this project in their spare time because they had no additional funding.

Ampatzis expected to see ganglions or relay neurons capable only of receiving or sending information. “But we found a very diverse set of neurons in a small network,” he said. Their findings included sympathetic, parasympathetic, and sensory neurons with apparent neurochemical and functional diversity. Most surprising was a subset of pacemaker neurons. “You cannot have a network that produces a rhythm without these neurons, and we didn’t expect exactly that, to be honest,” he said.

Pacemaker neurons are usually associated with so-called central pattern generator networks within the central nervous system. These independent, highly localized neuronal networks generate and control complex rhythmic behaviors such as respiration, mastication, urination, and ejaculation. “Most importantly, we found that this neuronal network works in an isolated heart, without brain information, and can change the rhythm of the heart and the regularity by itself,” said Ampatzis.

Further studies confirmed that neurons do not produce the rhythm, which is controlled by the cardiomyocytes. The neurons’ main function is to regulate the speed of the heartbeat. In other words, this smaller localized network acts as a kind of insurance system to safeguard the brain’s control of the heartbeat. “From an evolutionary perspective, I think that the system is like this because the heartbeat defines life,” Ampatzis added.

With the neurons of the heart mapped, medical researchers now have a toolbox of molecular markers, neurotransmitters, and other information on how such neurons function. These findings could become the basis of new research. It might be possible to investigate heart arrhythmia by modulating pacemaker neurons, Ampatzis suggested. “You could even repurpose or find specific drugs that can interfere with this local network of the heart,” he said, adding that this might be a less invasive option than is possible today.

Arrhythmia affects millions of people, said Oliver Guttmann, MD, a consultant cardiologist at The Wellington Hospital and honorary associate professor of cardiology at University College London, both in London, England. Beta-blockers remain the drug of choice for arrhythmia, but other options can be invasive. “We do ablations to try and burn or freeze certain areas of the heart to get rid of a rhythm because often this comes from hyperactive cells somewhere,” he said. Pacemakers and defibrillators are also needed to modulate dangerous rhythms. Innovation is focusing on making interventions far less invasive than they are today by creating smaller and smaller pacemakers, for example.

Moving from zebrafish to more complex mammalian systems will be the next big step, said David Paterson, DPhil, head of the Department of Physiology, Anatomy, and Genetics and honorary director of Burdon Sanderson Cardiac Science Centre at the University of Oxford, Oxford, England. “If you can find the molecular road map of dysregulation, then that could be a potential target for a gene therapy or cell therapy or for neuromodulation therapy,” he explained. Interest in this field, which is sometimes called bioelectronic medicine, is mounting. “It’s like pharmaceutics, but there’s no drug. You’re tapping into the wiring of the nervous system,” he added.

More radical research pathways might look at ways to tackle neurodegenerative disorders from dementia to Parkinson’s disease. “If neurons die in the brain, then they die in the heart and can affect the rhythm of the heart,” said Ampatzis. But zebrafish neurons are now known to produce substances that induce a proliferation of stem cells in bones, skin, and even the nervous system. “We think those neurons of the heart could perhaps contribute to the regeneration of the heart,” he said.

Source: https://www.medscape.com/viewarticle/zebra...

How Sensitive is Blood Pressure to Exercise? Guess what -- It Depends!

Here’s an article from the UK looking at a big group wearing activity trackers and evaluating what makes a difference for blood pressure.  The original article in Circulation is chocked full of interesting stuff for the data geek, and not surprisingly complex interrelationships are discovered between different types of activity and the resulting blood pressure effects.  What’s tricky is that the data is always reported for the population, and a change of less than 1 counts as significant  (but that wouldn’t be significant for you!).  A couple of meaningful takeaways are:

  1. If you don’t get enough sleep, getting more sleep will make a significant difference, especially if you kick in exercise (climbing stairs, exercise at the gym, running for the bus – not just walking) along with it.

  2. If you are sitting around a lot (more than 10 hours a day), AND you get a lot of sleep, getting MORE SLEEP WILL RAISE YOUR BP!  Getting more exercise definitely drop lower your blood pressure.

  3. It’s going to take 20-27 minutes of exercise a day to move your top BP number (systolic) and 10-15 minutes a day to more your bottom number (diastolic)

You’ve heard me say it before – get moving!

FROM MEDSCAPE UK / BY Jenny Blair

TOPLINE: 

Meaningful blood pressure reduction can take place by re-allocating as little as 10 minutes spent in other activities over a 24-hour period to exercise-like activity.

METHODOLOGY: 

  • Analysis of pooled data from six cross-sectional cohort studies, the Prospective Physical Activity, Sitting, and Sleep consortium (ProPASS) collaboration.

  • Participants (n = 14,761) wore 24-hour movement trackers.

  • Devices totaled average daily time spent doing six activities: sleeping, sedentary time, standing, slow walking, fast walking, and exercise-like activity.

  • The outcome of interest was blood pressure.

TAKEAWAY:

  • Each extra 5 minutes of exercise-like activity was linked to slight but statistically reductions in systolic and diastolic blood pressure (−0.68 mmHg and −0.54 mmHg, respectively).

  • The above reductions were meaningful in reducing, eg, stroke risk on the population level.

  • Exercising instead of other activities for an average of 20-27 minutes throughout the course of the day was estimated to result in clinically significant systolic reductions for individuals.

  • Similarly, exercising instead of other activities 10-15 minutes was estimated to result in clinically significant diastolic reductions.

IN PRACTICE:

"The exercise-like activities modelled in our study encompassed activities such as running, cycling, or inclined walking, and could include both structured, intentional exercise, and incidental daily activities such as running for a bus or climbing stairs," the authors wrote.

SOURCE:

Conducted by the international ProPASS Consortium, the study appeared in Circulation.

LIMITATIONS:

Causation not established. Sleep quality was not measured. Sample was not ethnically or racially diverse. Duration of bouts of exercise was not considered, only the daily average.

Source: https://www.medscape.co.uk/viewarticle/exe...

One of the reasons I'm Out Of Network

I once worked in a provider organization that was high on limiting inappropriate services.  Unfortunately, they wanted the doctors to jump through as many hoops as possible (I was strongly opposed).  In this case, they wanted to require precertification for CT scans of the abdomen – at that point (20+ years ago) this kind of precert it was largely unheard of.  I said no from a purely business perspective -- the number of cases that would ultimately be denied would be so small that there would be no savings.  I lost the argument because it was felt that the hoop alone was enough to produce savings.  And that’s where we were until recently.  

Now, there’s AI that allows even the hoop to be restrictive enough so that the request is essentially denied almost before it was conceived of!  If you think you’re getting screwed by the insurance company – odds are that you are!   

The following article is scary.  But it effects almost 1/3 of this country.  YIKES!

I can help you figure out if what you’ve asked for is really necessary, if there are alternatives, or if you need to fight harder.  Doesn’t mean you can win, but sometimes IT IS life or death.

FROM PROPUBLICA / BY T. CHRISTIAN MILLER, PATRICK RUCKER, DAVID ARMSTRONG

“Not Medically Necessary”: Inside the Company Helping America’s Biggest Health Insurers Deny Coverage for Care

Reporting Highlights

  • Dialing for Dollars: America’s largest insurers hire EviCore to make decisions on whether to pay for care for more than 100 million people.

  • “The Dial”: EviCore uses an algorithm that allows it to adjust the chances that company doctors will screen prior authorization requests, increasing the possibility of denials.

  • Lucrative Deals: Some EviCore contracts are based on how deeply the company can reduce spending on medical procedures. It tells insurers that it can provide a 3-to-1 return on investment.

These highlights were written by the reporters and editors who worked on this story. Were they helpful?

Every day, patients across America crack open envelopes with bad news. Yet another health insurer has decided not to pay for a treatment that their doctor has recommended. Sometimes it’s a no for an MRI for a high school wrestler with a strained back. Sometimes for a cancer procedure that will help a grandmother with a throat tumor. Sometimes for a heart scan for a truck driver feeling short of breath.

But the insurance companies don’t always make these decisions. Instead, they often outsource medical reviews to a largely hidden industry that makes money by turning down doctors’ requests for payments, known as prior authorizations. Call it the denials for dollars business.

The biggest player is a company called EviCore by Evernorth, which is hired by major American insurance companies and provides coverage to 100 million consumers — about 1 in 3 insured people. It is owned by the insurance giant Cigna.

A ProPublica and Capitol Forum investigation found that EviCore uses an algorithm backed by artificial intelligence, which some insiders call “the dial,” that it can adjust to lead to higher denials. Some contracts ensure the company makes more money the more it cuts health spending. And it issues medical guidelines that doctors have said delay and deny care for patients.

EviCore and companies like it approve prior authorizations “based on the decision that is more profitable for them,” said Barbara McAneny, a former president of the American Medical Association and a practicing oncologist. “They love to deny things.”

EviCore says it scrutinizes requests to make sure that procedures recommended by doctors are safe, necessary and cost-effective. “We are improving the quality of health care, the safety of health care and, by very happy coincidence, we’re also decreasing a significant amount of unnecessary cost,” an EviCore medical officer explains in a video produced by the company.

But EviCore’s cost-cutting is far from coincidental, according to the investigation.

EviCore markets itself to insurance companies by promising a 3-to-1 return on investment — that is, for every $1 spent on EviCore, the insurer would pay out $3 less on medical care and other costs. EviCore salespeople have boasted of a 15% increase in denials, according to the investigation, which is based on internal documents, corporate data and dozens of interviews with former employees, doctors, industry experts, health care regulators and insurance executives. Almost everybody interviewed spoke on condition of anonymity because they continue to work in the industry.

An analysis of the company’s own data shows that, since 2021, EviCore turned down prior authorization requests, in full or in part, almost 20% of the time in Arkansas, which requires the publication of denial rates. By comparison, the equivalent figure for federal Medicare Advantage plans was about 7% in 2022.

EviCore has several ways to cut costs for insurers. Chief among them is the dial, the proprietary algorithm that’s the first stop in evaluating a prior authorization. Based on data entered by a doctor’s office, it can automatically approve a request.

The algorithm cannot say no, however. If it finds problems, it sends the request for review to a team of in-house nurses and doctors who consult company medical guidelines. Only doctors can issue a final denial.

This is where tweaking the dial comes in. EviCore can adjust the algorithm to increase the number of requests sent for review, according to five former employees. The more reviews, the higher the chance of denials.

Here’s how it works, the former employees said: The algorithm reviews a request and gives it a score. For example, it may judge one request to have a 75% chance of approval, while another to have a 95% chance. If EviCore wants more denials, it can send on for review anything that scores lower than a 95%. If it wants fewer, it can set the threshold for reviews at scores lower than 75%.

“We could control that,” said one former EviCore executive involved in technology issues. “That’s the game we would play.”

Over the years, medical groups have repeatedly complained that EviCore’s guidelines were outdated and rigid, resulting in inappropriate denials or delays in care. Frustration with the rules has led some doctors to refer to the company as EvilCore. There is even a parody account on X.

The guidelines are also used as a tool to cut costs, the investigation found. Company executives “would say, ‘Keep a closer eye on the guidelines for reviews for a particular company because we’re not showing savings,’” said a former EviCore employee involved in the radiation oncology program.

EviCore says that it develops its guidelines with the input of peer-reviewed medical studies and professional societies, and that they are routinely updated to stay current with the latest evidence-backed practices. It said its decisions are based solely on the guidelines and are not interpreted differently for different clients.

EviCore is not alone in engaging in the denials-for-dollars business. The second-biggest player is Carelon Medical Benefits Management, a subsidiary of Elevance Health, the health insurer formerly known as Anthem. It has been accused in court of wrongfully denying legitimate requests for coverage. The company has denied all charges. Several smaller companies do the same kind of work.

There is no question that prior authorizations play an important role in modern medicine. They serve to guard against doctors who recommend unnecessary and even potentially harmful treatments. They also protect insurers from fraudulent physicians who overbill for services.

In a response to questions, a Cigna spokesperson provided a statement on behalf of EviCore. “Simply put, EviCore uses the latest evidence-based medicine to ensure that patients receive the care they need and avoid the services they do not,” it said.

The statement acknowledged that EviCore used algorithms for some clinical programs, but “ONLY to accelerate approval of appropriate care and reduce the administrative burden on providers.”

The statement noted that doctors have the ability to appeal prior authorization denials, and that the company routinely monitors the outcomes “as part of our continuous quality improvement to ensure accurate and timely medical necessity decision-making.”

Prior authorization reviews provided by EviCore save money for the entire health insurance system, the statement said. “The natural product of improved care quality and reduced waste is savings for our clients, lower out-of-pocket costs for patients, and fewer health care premium increases for Americans.”

Turning the Dial

In the fall of 2021, when the air grew crisp and the leaves reddened in central Ohio, Little John Cupp began feeling short of breath. He gasped while pushing a shopping cart. His feet and ankles swelled. He could only sleep while sitting up.

An echocardiogram revealed that his heart was having trouble pumping blood. Cupp’s doctor suggested more testing, including the insertion of a catheter to examine whether his arteries were blocked.

A few days after the doctor made the request, Cupp received a letter from his insurance company, UnitedHealthcare. The procedure, it said, was “not medically necessary.”

Little John Cupp provided support for his family, including buying a new four-bedroom trailer. Credit:Courtesy of Chris Cupp

One sentence in 8-point type revealed that the insurer had outsourced the decision to EviCore.

Cupp’s doctor put him on medications to reduce swelling and high blood pressure and tried a second time to win approval for a left heart catheter examination. EviCore turned it down again. He revealed his disappointment in shorthand in Cupp’s medical records: “ideally he needs LHC (denied twice by insurance).”

Cupp was 5-foot-7 and 282 pounds, with a wedding ring the size of a quarter. He had a white beard, his face wide and warm. He wore blue jean overalls and scuffed leather work boots. He had spent most of his life as a welder, working at metal fabrication shops in and around his hometown of Circleville, Ohio, population 14,063. He was 61, nearly the same age as his father when he died from a massive heart attack. Cupp was a stoic, his daughter Chris said, but the denial worried him.

“Well, I have to call the doctor and see what we’re going to do,” he told her after the second rejection.

The doctor decided to give up on getting an approval for the catheter exam. In challenging EviCore, he was fighting not just a company but an industry.

EviCore is the product of a massive, decadeslong push by insurance companies to control health care costs. They point to studies that show 20% to 45% of some medical treatments are wasteful or ineffective. To decrease such spending, insurers began requiring doctors to seek permission for medical care before agreeing to pay for it — a process known as “utilization review.” As treatments became more complex, the reviews proved costly in themselves.

Created from a 2014 merger of two smaller companies, EviCore offered a solution: It allowed insurers to outsource prior authorization decisions for the most specialized and expensive procedures. EviCore today issues recommendations for imaging, oncology, cardiology, gastroenterology, sleep problems and many other fields.

It works with more than 100 insurers across the country, including industry titans such as UnitedHealthcare, Aetna and Blue Cross Blue Shield and some Medicare and Medicaid contractors. Cigna took over the company in 2018, but EviCore maintains its independence by blocking insurers from prying into one another’s proprietary data.

In responses to inquiries, the large insurance companies said they hired EviCore as a way to make sure that customers received safe and necessary medical treatments, while holding down costs for inappropriate care.

EviCore built its business by relying on different types of contracts. In one, a health insurance company pays EviCore a flat rate to review coverage requests.

Another type is more lucrative, providing an incentive for EviCore to cut costs, former employees said. Known as risk contracts, EviCore takes on the responsibility for paying claims. As an example, say an insurer spends $10 million a year on MRIs. If EviCore keeps costs below that figure, it pockets the difference. In some cases, it splits the savings with the insurance company.

“Where you really made your money was on a risk model,” a former EviCore executive said. “Their margins were exponentially higher.”

EviCore teams involved in developing the algorithms and contracting with clients “operate separately” from reviewers “to prevent any potential conflicts of interest,” according to the statement from Cigna’s spokesperson.

Insurers do not make explicit demands for more denials, a former EviCore sales executive said, Instead, they asked about “controlling the spend” — the amount of money paid out on certain procedures, he said. Nor would EviCore always use the word “denials” — they employed circumlocutions like “inappropriate determinations.”

Aetna and Cigna are two of the companies that have requested “high touch” plans — those that would send more cases to clinical review and thus generate more denials, according to the former employee involved in data issues.

Aetna did not directly respond to whether it used “high touch” plans. “Although we never automate medical necessity denials, we automate and provide real-time approval of some services to ease administrative burden and allow providers to focus on patient care,” the insurer said in a statement. Cigna did not respond to questions about its use of such plans.

“When you have human eyes on something, you can pick up where there might be a gray area where the algorithm might not pick up,” a former EviCore account executive said. “That is how you would increase the denial rate.”

EviCore can also adjust the algorithm to achieve its internal goals, without the knowledge of clients, former employees said. This happened when EviCore was not generating enough savings to demonstrate its value to insurers, several former employees told ProPublica.

“The pressure from our business leaders was to make sure that we were able to provide evidence of a strong enough impact to justify the contracts with clients,” said the former employee involved with technology.

The system also runs in reverse. When doctors or employer health plans complain about high rejection rates, insurance companies can ask EviCore to back off. The company simply adjusts its algorithm to approve more prior authorization requests.

Dave Jones, a former California insurance commissioner and now director of the climate risk initiative at the University of California, Berkeley School of Law, said arbitrarily increasing or decreasing manual reviews didn’t appear to violate any standards. Still, he questioned whether a payment structure or contract for EviCore based on reducing claims payments or authorizations would result in objective and thorough evaluations of prior authorization requests, as required by law.

“That to me is troubling,” Jones said. “It suggests that the claim settlement procedure is not objective, right?” He added, “It calls into question everything that’s occurring.”

Other industry experts found the manipulation of denial rates upsetting.

“The fact that these big companies focused on profits and can play all these games is quite disturbing to me,” said Martin Lustick, a former insurance executive and the author of a book on industry practices. “They know the more reviews they do, the more denials they get.”

Disputed Guidelines

On March 2, 2022, Cupp and his daughter entered the Adena Regional Medical Center, a gray and glass building surrounded by central Ohio’s low rolling hills.

It had been almost three months since EviCore first turned down coverage for the catheterization. Changing tack, Cupp’s doctor ordered a new exam, which EviCore approved, called a nuclear stress test. It shows how well blood flows through your heart.

A heart catheterization generally costs around $3,500 when done in network, according to Fair Health, a nonprofit that tracks health care prices. A nuclear stress test runs about $315.

Afterward, Cupp greeted Chris in the waiting room. He told her he felt fine. They went for lunch at a favorite hamburger spot. At the time, they did not know the results of the stress test, which showed that his heart was pumping even less blood than indicated by his echocardiogram.

At each step of the way, EviCore had steered Cupp’s medical treatment by denying or approving his doctor’s coverage requests based on its own internal guidelines.

Those guidelines have long been the subject of complaints from doctors. Over the past five years, organizations ranging from the American College of Cardiology to the Society for Vascular Surgery to ASTRO, the American Society for Radiation Oncology, have written to EviCore or regulators that the guidelines are flawed and can interfere with delivering the right care for patients. Benjamin Durkee, a doctor who chairs ASTRO’s payor relations committee, said EviCore had generally made “a good faith” effort to respond to the society’s concerns. But, he noted, the company continues to consistently deny a radiation treatment called proton beam therapy for some pelvic tumors that is more costly but supported by ASTRO’s recommendations.

In a 2019 letter to EviCore, the Society for Vascular Surgery expressed concern about the company’s medical guidelines. Credit:Obtained by ProPublica. Highlighted by ProPublica.

A 2023 academic study examined the criteria EviCore used to approve payment for imaging of the lower spine in cases of extreme pain. It found the guidelines deficient. Two of five medical experts who reviewed the guidelines even recommended not using them.

A 2018 audit by the Centers for Medicare and Medicaid Services, obtained through the Freedom of Information Act, found that Health Care Service Corporation, a Blue Cross Blue Shield insurer, had hired EviCore to review prior authorizations. EviCore, the audit found, played a role in making “inappropriate denials” for 30 patients because it failed to keep its cancer guidelines up to date. As a result, EviCore retrained its staff. HCSC did not respond for comment.

Former employees have also questioned how the guidelines were put to use.

A maternal-fetal medicine physician in Colorado, Gail Miller, took a job as a doctor at EviCore in 2018. The idea of ensuring safe medical practices appealed to her. But she soon grew convinced that EviCore was more interested in saving money.

EviCore rejected her suggestions for improving its maternal fetal health guidelines. Her supervisor required her to decide at least 15 cases an hour — or one every four minutes. She often reviewed requests by physicians outside her specialty.

Nine months after starting at EviCore, Miller quit, disappointed by the attitudes of some of her colleagues. “Most of the physicians who work at these places just don’t care,” she said. “Any empathy they had is gone.”

EviCore noted its clinical staff had “high engagement, satisfaction and retention rates.” It said the most common reason for denying a prior authorization is because doctors neglect to include necessary information.

Results

EviCore meets regularly with insurers and state Medicaid programs. It is a critical part of the business. The company has to demonstrate savings or clients will have little reason to continue their contracts.

Typical was a 2019 meeting with Vermont’s Medicaid program, which for years had used EviCore to review coverage requests for advanced radiology and cardiology scans. A slide show demonstrated how the company had helped lower costs for cardiac imaging through denials. Rates had zigzagged, from a high of almost 15% of requests in one three-month period to a low of 6.1% in another.

But the presentation, obtained through Vermont’s Public Records Act, revealed another way that EviCore saved money for insurers. Prior authorization requests for radiology imaging services had dropped to 3,629, a decline of 16%. Cardiology requests had plummeted even more — down 38% in a little more than a year. Doctors had simply stopped asking for procedures for their patients.

An EviCore executive called this the “sentinel effect” at a legislative hearing in Kansas. It is like the sheriff coming to town. Once doctors know EviCore is watching, they make fewer inappropriate prior authorization requests, he said.

Doctors, however, say that such decreases reflect how difficult it is to fight EviCore and similar companies. Their entrance into the market frustrates doctors from making otherwise legitimate requests.

In its statement, Cigna described the sentinel effect differently. The company said that it helps doctors stay up to date on best practices. “Sentinel effect refers to the reduction in frequency with which physicians order inappropriate services because they are now aware of the latest clinical evidence,” the statement read.

A spokesperson for Vermont’s Medicaid program said the state does not believe that EviCore made unfair or unsound coverage recommendations. Instead, EviCore helped Vermont make “sound decisions from both a fiscal and patient care perspective.”

“It is never a goal for the state of Vermont or our third-party contractors to deny service,” said Alex McCracken, spokesperson of Department of Vermont Health Access. “We are committed to delivery of service for our customers.”

Vermont eventually ended its contract with EviCore because it decided to no longer require prior authorization for advanced imaging scans in its Medicaid program.

“Too Much Say”

The day after his stress test, Cupp drove to his granddaughter’s high school to drop off her archery bow — it had been left behind in the morning rush. He and his wife went shopping at the grocery store. That evening, he watched as his grandkids showed off some baby frogs they had purchased at a pet store.

He went to bed at 8:30 p.m. in order to wake at 2:30 a.m. for the hourlong drive to his job as a maintenance worker at a medical supplies warehouse just south of Columbus.

At about 10:30 p.m., Cupp’s wife, Vivian, shook Chris awake. “Your dad’s breathing funny,” she told her. Chris ran into their bedroom. Her father was gasping for air. Suddenly, he stopped. Chris began CPR. She told her mom to call 911.

By the time the ambulance arrived at Adena Regional Medical Center, where he had received his nuclear stress test 36 hours earlier, his body was mottled and cool. He had suffered cardiac arrest. The time of death was 11:39 p.m.

Chris Cupp, in the home she shared with her family in Bainbridge, Ohio, has been devastated by her father’s death. Credit:Maddie McGarvey for ProPublica

ProPublica asked four cardiology experts to review Cupp’s medical situation. One cardiologist said she would not have recommended a heart catheterization. Given his symptoms, which did not include complaints about chest pain, the best diagnostic tool would have been the stress test, she said.

Three others said the heart catheterization was appropriate. One cardiologist noted that Cupp was diabetic, overweight and showed signs of having suffered a prior heart attack. “It’s very reasonable to say we’ll just go straight to a heart catheterization,” the cardiologist said.

If Cupp had received the procedure when first ordered, his life may have been saved, one expert said. “The doctor was absolutely right to order the catheterization. It was certainly necessary,” said Jonni Cooper, president of American Board of Cardiovascular Medicine and a board certified cardiovascular nurse practitioner.

State and federal regulators rarely impose onerous penalties on companies like EviCore.

Connecticut’s Insurance Department recently reviewed EviCore and Carelon. It found no problems with Carelon. EviCore was fined $16,000 this year for more than 77 violations found in a review of 196 files. EviCore is also accredited by two trade associations, which review companies periodically for compliance with industry standards.

Holding the companies legally responsible for their decisions is also difficult. In 2022, Carelon settled a lawsuit for $13 million that alleged the company, then called AIM, had used a variety of techniques to avoid approving coverage requests. Among them: The company set its fax machines to receive only 5 to 10 pages. When doctors faxed prior authorization requests longer than the limit, company representatives would deny them for failing to have enough documentation. Carelon denied the allegations in court and admitted no fault. A spokesperson declined to comment on the lawsuit.

Elevance, Carelon’s parent company, said its subsidiary “is focused on improving health outcomes while also lowering the cost of care.”

This year, Chris, representing Cupp’s estate, sued United Healthcare, EviCore, the Adena Regional Medical Center and Cupp’s doctor, accusing them of malpractice, among other allegations. Cupp’s attorney, John Markus, later decided to drop United and EviCore. Lawsuits against employer-funded health plans, like the one Cupp had with United, must be tried in federal court, where case law favors insurance companies. For instance, insurers found at fault do not pay punitive damages, only the cost of treatment. The medical center and the doctor declined to comment, citing the ongoing litigation. In court, both denied any wrongdoing. United and EviCore declined to discuss Cupp’s case, despite an offer from Chris to sign a waiver of medical privacy rights.

Her father’s death wracked Chris. He had been her best friend. He helped raise her three kids. He provided for the family. Two years before his death, he purchased a new double-wide trailer to replace a rusting single-wide the family had lived in for years. It had four bedrooms, enough for everyone. It stood on the side of a hill, surrounded by oak and maple, a leafy retreat with a view of the valley below.

Cupp was buried at a cemetery across from a cornfield on March 9. A gray granite headstone marks his date of death.

Chris Cupp drives a school bus to make ends meet. For extra pay, she picks up a lot of the trips for night games. She says she hopes that no one else has to go through what she did.

“Insurance has too much say over something that can save your life,” she said. “When it comes to your heart, something that’s going to kill you, they have too much say in that. That’s my thought about it.”

I spent nearly 20 years with some responsibility for managing care for more than just my patients – I worked as a medical director with liaison responsibilities for as many as 100,000 patients.  That meant different things at different times, but it all had to do with ensuring that the patients got the best care for the least amount of money.  For me, the priority was on the best care, but if you know me, you know I see the waste in the system.  Over the past decades now there has been a strong focus on decreasing cost, and from my perspective, resulting in “the hell with the patient”.  Ok, that might be overstated, but if you’re the individual, you could easily be screwed.   

Years ago a patient with migraines was prescribed botox when it was still largely experimental.  The insurance company at the time reviewed the case, the specific patient history, and approved a trial.  When the treatment worked, it was ultimately approved going forward.  The patient’s employer changed insurances, and the process started up again.  This time, despite a long history of successful treatment, and the fact that the FDA approved botox for migraines, and that the Neurological Society came out in favor of including botox as a regular therapy, the insurance company denied the service.  And the patient went back to being miserable until they could pay out of pocket for the only therapy that had worked.  

Source: https://www.propublica.org/article/evicore...

Even a little exercise can really change your life's trajectory

One day you go to the doctor and he says “you have diabetes”, as if you just got it.  WRONG!  You’ve been working on it for years – many, many years.  Your sugar ever so slowly starts to climb (your body can’t keep up) until it reaches the level that your regular doctor finally tells you’ve hit the dreaded “D”-level.  But as you’ve heard, exercise can make a huge difference – but how much of a difference?  

This study, while small, has profound implications.  Hang in there while I try to explain it – it’s a little complicated if you are unfamiliar with the particulars.  Some definitions first.

Think of an oral glucose tolerance test (OGGT) as drinking a sickeningly sweet drink all at once, then checking blood sugar levels an hour and two later.  Insulin sensitivity is how relatively self-explanatory – how sensitive your body is to insulin (hint – it should be really sensitive), and type 2 diabetes is all about insulin insensitivity (also known as glucose intolerance).  

The study takes young (average age 35) people who are sedentary or moderately active, normal to slightly overweight, with no evidence of diabetes and tests them with OGGTs.  First, they’re asked to sit around for 4 days and then they’re tested, giving us some blood sugar and insulin levels.  They are then asked to do an easy jog for 30 minutes and are tested again on the following day.  

The findings are profound – a significant drop in blood sugars and insulin levels after the simple jog.  That’s after 1 jog!  What if someone actually did REGULAR exercise!!!  

Research studies have shown that a full 25% of normal, skinny, healthy, active youth (college age) already show evidence of being on the way to diabetes.  I’m sure some of these subjects were among the group that would have qualified, but if we can’t know who’s at risk, and we have an opportunity to seriously impede progress to a life-threatening condition, why wouldn’t we take advantage!?!  

But hey, here I am talking about exercise again.  Go figure.

A Single Jog Can Improve Glucose Metabolism in Young Adults

TOPLINE:

In healthy young adults, a single 30-minute bout of outdoor aerobic exercise significantly reduces fasting and 1-hour glucose levels during an oral glucose tolerance test (OGTT) the next day and improves insulin sensitivity.

METHODOLOGY:

  • Recent studies have identified 1-hour post-load glucose concentration during an OGTT as a specific and early predictor of diabetes, and exercise has long been known for its metabolic benefits in people with and without diabetes.

  • The researchers investigated the effect of a single bout of aerobic exercise on 1-hour post-load glucose levels during an OGTT in 32 young, healthy, normal-weight or marginally overweight individuals (mean age, 35 years; 14 women and 18 men) with a sedentary or moderately active lifestyle.

  • The participants underwent an initial OGTT after at least 4 days of physical inactivity, followed by a second OGTT the day after a single 30-minute bout of aerobic exercise.

  • The exercise session consisted of a light jog for 30 minutes, monitored using a metabolic holter to quantify energy expenditure and exercise intensity. The participants did not undertake any exercise outside the lab sessions.

  • Blood glucose levels were measured, and insulin sensitivity and secretion were estimated using surrogate indices derived from OGTT glucose and insulin assays, including the Matsuda index, oral glucose insulin sensitivity (OGIS) index, and quantitative insulin sensitivity check index, as well as the homeostasis model assessment (HOMA) of insulin resistance and of beta-cell function (HOMA-B).

TAKEAWAY:

  • A single 30-minute bout of aerobic exercise significantly reduced 1-hour post-load glucose levels from 122.8 mg/dL at baseline to 111.8 mg/dL ( = .03) the day after exercise.

  • Postexercise insulin levels also were significantly lower 1 hour after glucose load, decreasing from 57.4 IU/mL at baseline to 43.5 IU/mL the day after exercise ( P = .01).

  • Insulin sensitivity improved significantly after exercise, as indicated by increases in the Matsuda index ( = .02) and OGIS index ( = .04), along with a reduction in insulin resistance ( = .04).

  • The study found a trend toward increased beta-cell function the day after an exercise bout, as indicated by a nonsignificant increase in HOMA-B from 144.7 at baseline to 167.1 after exercise.

IN PRACTICE:

“Improvement in 1-hour post-load plasma glucose following a single session of aerobic physical activity suggests that exercise could have a direct effect on T2D [type 2 diabetes] risk and cardiovascular risk,” the authors wrote.

SOURCE:

The study was led by Simona Moffa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, and Gian Pio Sorice, University of Bari "Aldo Moro," Bari, Italy. It was published online in the Journal of Endocrinological Investigation .

Source: https://www.medscape.com/viewarticle/singl...