To Drink or Not to Drink? That is the question...

For a long time there’s been this idea that a drink or two a day will actually extend your life.  That’s been at odds with the fact that alcohol is clearly a toxic substance – it is a direct poison to heart muscle, for example.  The concept of hormesis is usually employed as the argument – the idea of whatever doesn’t kill you makes you stronger.  Well, that’s not what the latest up-dated meta-analysis shows.  In fact, there’s no real health difference between not drinking, less than 2 drinks a day and even 2-3 drinks a day.  If you got to 3-4 drinks, though, there’s nearly a 20% increase in all-cause mortality (risk of dying), and at more than 4 ½ drinks a day that risk goes up 35%!

SO, if you want a drink, have one, or even two (assuming your heart can take it!), but going further regularly will cost you. SKOL!

FROM MEDPAGE TODAY / BY KRISTEN MONACO

That glass of red wine with dinner probably won't protect you from an early grave, according to an updated meta-analysis on the longevity impact of alcohol.

Compared with never-drinkers, "low-volume" drinkers who kept daily alcohol intake under two drinks (1.3 to 24 g ethanol) each day didn't see any reduction in the risk for death from any cause (relative risk 0.93, 95% CI 0.85-1.01), found researchers led by Jinhui Zhao, PhD, a scientist and senior data analyst at the University of Victoria's Canadian Institute for Substance Use Research, in British Columbia.

A typical 12-oz beer or 5-oz glass of wine in the U.S. contains about 14 g of pure ethanol.

"Medium-volume" consumers who threw back about three drinks per day (25 to 44 g of ethanol) also didn't see any significant protection or harm from their habits when compared with non-drinkers (RR 1.05, 95% CI 0.96-1.14), the group reported in JAMA Network.

"Our study gives strong grounds for scepticism regarding the comforting idea that alcohol in moderation is good for health," co-author Tim Stockwell, PhD, also of the University of Victoria, told MedPage Today by email, adding that there continues to be controversy on this topic.

"The idea that alcohol is beneficial in moderation has a profound influence on global, national, and regional estimates of alcohol's impact on health and safety," he explained. "It also has profound implications for guidelines prepared by health authorities for alcohol drinkers wishing to reduce health risks."

While low or moderate alcohol intake didn't appear to increase the risk for death in this study, it was consistent with others in suggesting there also weren't any actual health benefits, said Timothy K. Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai in New York City.

"No alcohol is best," he told MedPage Today. "Drinking less is always better for our bodies than drinking more."

"It is clear from this study -- and many others -- that heavy drinking not only increases the likelihood of developing a variety of diseases, but it also increases the risk of dying," noted Brennan, who wasn't involved with the study.

Drinking any more than about three drinks in a typical day started to catch up with folks, the researchers found.

People considered "high volume" drinkers in the study -- this included those who drank anywhere between 45 to 64 g of ethanol each day -- saw a 19% higher relative risk for all-cause mortality (RR 1.19, 95% CI 1.07-1.32).

Following an upward pattern, consumers of more than about 4.5 drinks a day (65 g ethanol) saw the highest risk for an early death, with a 35% higher risk for all-cause mortality compared with lifetime abstainers from booze (RR 1.35, 95% CI 1.23-1.47).

Even when compared with just the occasional drinker -- those who keep it under one drink a week -- high and higher-volume drinkers still saw significantly higher risks for death.

But the "safe" threshold for drinking was lower for women.

When just looking at data on females, even medium-volume drinking wasn't without health risks. Women drinking around two to three servings (25 to 44 g of ethanol) daily saw a 21% higher risk of death from any cause compared with women who completely abstained from alcohol (RR 1.21, 95% CI 1.08-1.36). On top of that, high- and higher-volume female drinkers had a 34% and 61% increased risk for death, respectively.

Overall, Brennan advised that men limit their alcohol intake to two drinks per day or less and women should limit their intake to one drink per day or less.

While all ages generally saw the same pattern -- higher all-cause mortality linked with more than three drinks per day -- the magnitude of this risk was more pronounced for those under age 56. Because of this, the researchers suggested future studies home in on this younger age group.

The fully adjusted models took into consideration factors like abstainer biases, age, sex, study country, drinking patterns, lifestyle factors, and more.

Data on over 4.8 million individuals and 425,564 deaths were compiled as part of this updated systematic review and meta-analysis, which included 107 studies in more than 20 countries published from 1980 to 2021.

These findings support those from two prior meta-analyses conducted by the same research group. In 2016, the researchers found a trend suggesting that low-volume daily drinking might help stave off death from any cause, but this risk reduction disappeared after adjustment for abstainer biases and quality-related study characteristics. A year later, the researchers found mixed results when looking at the link between alcohol and coronary heart disease.

As the third installment in their series, the current meta-analysis was able to incorporate the last few years of new data. "Our study summarized results from every published study on the topic canvassing the life experiences of nearly 5 million individuals," said Stockwell.

"Our focus is on the validity of the hypothesis that alcohol in moderation is beneficial for health," he added.

However, the group said that the available research on the topic is still riddled with drinker misclassification errors, as 86 of the studies included former drinkers or occasional drinkers in the abstainer group used for comparison. Only 21 of these studies were actually free of abstainer biases.

"The importance of controlling for former drinker bias/misclassification is highlighted once more in our results which are consistent with prior studies showing that former drinkers have significantly elevated mortality risks compared with lifetime abstainers," Zhao's group said.

For example, they found former drinkers carried a 26% higher risk for death from any cause than lifelong abstainers (RR 1.26, 95% CI 1.12-1.42). This lends support to the notion of "sick quitters," or former drinkers who quit due to health reasons.

Stockwell also pointed out how studies of older people are the most biased toward finding health benefits from moderate drinking.

"One of the reasons for this is that older people who continue to drink tend to be particularly robust and healthy, while those who stop drinking often do so because they have become unwell," he explained.

"Being able to continue drinking at an older age is a sign -- not a cause -- of good health," said Stockwell.

Source: https://www.medpagetoday.com/primarycare/p...

You CAN reverse Diabetes, but you better do exercise, too!

A really interesting study of prediabetes says that simply reversing prediabetes doesn’t cut your risk of dying. Of course, a big percentage of people will progress to diabetes, and their risk of dying goes up 50%.  But just getting the sugar normal will not, by itself, keep you alive longer.  You have to do exercise!  If you drop your sugar AND you do exercise you cut your risk of dying by around 30%, translating to another 2- 2.5 years of life. 

FROM MEDPAGE TODAY / BY KRISTEN MONACO

Reduced risk only seen in physically active patients, Taiwanese study found

Reversing prediabetes was not associated with a lower mortality risk, according to a Taiwanese cohort study of more than 45,000 adults.

Over 8 years of median follow-up, patients who reversed their condition to a state of normoglycemia didn't experience a significantly lower risk for all-cause, cancer-related, or cardiovascular-related death compared with those who remained in persistent prediabetes, reported Xifeng Wu, MD, PhD, of Zhejiang University in China, and colleagues.

"Interestingly, reversion to normoglycemia combined with the adoption of healthy behaviors, such as a higher level of physical activity and no current smoking, were associated with a substantially lower risk of death and longer life expectancy," the authors wrote in JAMA Network. "These findings highlight the importance of lifestyle modifications among individuals with prediabetes status."

Across multiple analyses looking at modifiable risk factors and all-cause mortality, the only groups with a significantly lower risk were patients who were physically active and either reversed their prediabetes (HR 0.72, 95% CI 0.59-0.87) or remained in a state of prediabetes (HR 0.77, 95% CI 0.66-0.90), with both groups compared with inactive individuals with persistent diabetes. These differences translated to roughly a 2- to 2.5-year longer life expectancy.

Physically active individuals were clocking 7.50 or more metabolic equivalent of task (MET) hours per week, while inactive individuals were getting less than 3.75 MET hours per week. No benefit was seen for individuals who were "moderately" active (3.75-7.49 MET hours per week). Though it depends on someone's body weight, a brisk walk can typically range from 3 to 6 METs, according to the CDC.

While individuals with obesity didn't see a significant death protection by reversing prediabetes (HR 1.10, 95% CI 0.82-1.49) compared with those of normal weight with persistent prediabetes, those who stayed in a prediabetic state with obesity carried an excess risk for death (HR 1.33, 95% CI 1.10-1.62).

And normoglycemia still couldn't offset the risks that came with smoking, as current smokers carried a similar 60-61% higher mortality risk whether they had achieved normoglycemia or remained in persistent prediabetes when compared with never smokers with persistent prediabetes. This translated to roughly 3 to 3.5 years less of life expectancy for the current smokers.

This pattern was not seen with alcohol drinkers, though.

The 45,782-person population-based cohort study gathered data from the Taiwan MJ Cohort Study, which recruited participants from 1996 to 2007. In the entirely Asian cohort, 63% were men, and average age was 44.6 years.

Within the first 3 years after study enrollment, 3.9% progressed to full-blown type 2 diabetes, while 37.2% reversed back to normoglycemia. Over the median 8-year follow-up period, 1,528 deaths occurred, including 671 from cancer and 308 from cardiovascular disease.

Not surprisingly, those who progressed to full-blown type 2 diabetes over the 3-year period had a higher risk for all-cause and cardiovascular-related mortality than those who persistently stayed in the prediabetic state:

  • All-cause mortality: HR 1.50 (95% CI 1.25-1.79)

  • Cardiovascular-related mortality: HR 1.61 (95% CI 1.12-2.33)

Wu and co-authors noted that the results of their study "extended previous findings by confirming that the association between prediabetes and the risk of death might be explained by progression from prediabetes to diabetes."

Diabetes status was ranked according to fasting plasma glucose level by American Diabetes Association criteria: normoglycemia (<100 mg/dL), prediabetes (100-125 mg/dL), diabetes (≥126 mg/dL). All were measured with overnight fasting blood samples taken in the morning.

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

Genetic evaluation should be used for more than chemotherapy!

Currently, in conventional medical practice, the term “personalized medicine” routinely refers to identifying the genetics of some cancerous tumor so as to “tune” chemotherapy.  Of course, I’ve been using genetic evaluations from a wide variety of providers depending on specific needs, none of which involves a cancerous tumor.  The attached abstract hints at the value that an appropriate genetic evaluation could have for both individuals and populations.  By running patients with high blood pressure through a genetic test panel (only 10 genes) that then translated into much more effective high blood pressure treatment in a much shorter time than in the population receiving usual care.  Since about 45% of strokes occur in patients with hypertension who aren’t adequately controlled, controlling blood pressure more quickly through genetic could easily pay for itself in better outcomes (and it real dollars!).  

One could ask why we don’t do this… but that would just be a silly question, right?

FROM SCIENCE TRANSLATIONAL MEDICINE / BY QI SHEN HONGHONG ZHANG, YIMING HUANG, MINGYU LI, HAO ZHAO, ZHIWEN YANG, HAIJING ZHAO, QI LIU, ZIHAO FU, SHU WANG

Genetic variants among individuals have been associated with ineffective control of hypertension. Previous work has shown that hypertension has a polygenic nature, and interactions between these loci have been associated with variations in drug response. Rapid detection of multiple genetic loci with high sensitivity and specificity is needed for the effective implementation of personalized medicine for the treatment of hypertension. Here, we used a cationic conjugated polymer (CCP)–based multistep fluorescence resonance energy transfer (MS-FRET) technique to qualitatively analyze DNA genotypes associated with hypertension in the Chinese population. Assessment of 10 genetic loci using this technique successfully identified known hypertensive risk alleles in a retrospective study of whole-blood samples from 150 patients hospitalized with hypertension. We then applied our detection method in a prospective clinical trial of 100 patients with essential hypertension and found that personalized treatment of patients with hypertension based on results from the MS-FRET technique could effectively improve blood pressure control rate (94.0% versus 54.0%) and shorten the time duration to controlling blood pressure (4.06 ± 2.10 versus 5.82 ± 1.84 days) as compared with conventional treatment. These results suggest that CCP-based MS-FRET genetic variant detection may assist clinicians in rapid and accurate classification of risk in patients with hypertension and improve treatment outcomes.

SNPing out hypertension

Essential hypertension has multiple genetic risk factors that can affect both its incidence and response to treatment. Here, Shen and colleagues developed a simple, high-throughput fluorescent assay for detection of two different single nucleotide polymorphisms (SNPs) in a single reaction. They applied this method in a prospective study to screen for variants at a total of 10 loci associated with hypertension and guide medication use based on drug class-associated risks. Patients treated according to this precision medicine approach had improved blood pressure control over a 7-day period compared with those treated using standard guidelines. These results suggest that this assay should be further studied and may be useful in resource-limited settings.

Source: https://www.science.org/doi/10.1126/scitra...

With a Simple Blood Test, It’s Easier than Ever to detect Brain Injuries

Concussions are common and can have serious consequences.  If you show up at the ER with a head injury, chances are you’ll get a CT scan of your head.  But going forward that may be overkill – a blood test will reliably be able to tell you if you don’t need one.  That could save hours and hours at the hospital.  That would be great for most people.  Of course, conventional medical practice does little to help those who end up having a concussion, but we can help you with that.  There’s lots of options, all of which will help improve the condition more quickly, so long as you actually do something about it.  The usual advice is rest, take it easy.  Yes, but there are supplements and therapies that can be applied and accelerate healing.  Keep that in mind should you have this issue.  I’m here to help!

FROM ABBOTT LABS

Abbott has received U.S. Food and Drug Administration clearance for what will be the first commercially available laboratory traumatic brain injury (TBI) blood test, making it widely available to hospitals in the United States. The test, which runs on Abbott's Alinity® i laboratory instrument, will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions.

Abbott's Alinity i TBI lab test offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.

For decades, standard concussion assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. Having a blood test available could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing costs to the healthcare system and the patient as well as the amount of time they spend in the emergency department.

Millions of people in the U.S. suffer a concussion each year, but more than half of people who suspect they have a concussion never get it checked.

"People sometimes minimize a hit to the head, thinking it's no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury."

TBIs are caused by a bump, blow or whiplash to the head and can pose risk of both short- and long-term effects. People who experience a TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can last anywhere from a few days post-injury or may be permanent. People who sustain a TBI are more likely to have another one – similarly to how a sprained ankle or torn ligament is more susceptible to future injury.

These effects are worsened by misdiagnosis or lack of diagnosis, so providing tools that can objectively aid in the evaluation of a TBI or concussion is essential to giving people the answers and treatment they need.

Abbott has been pioneering breakthroughs in TBI testing technology for over a decade. This FDA clearance complements Abbott's i-STAT TBI Plasma test, the first rapid blood test for concussion, which is already cleared by the FDA. With the Alinity i clearance, a TBI blood test can now be run on Abbott's high throughput Alinity i laboratory instrument. The advancement will make TBI testing more available because the Alinity i instrument is widely used in hospitals and laboratories across the U.S.

The Alinity i test can be used when a patient shows up to the hospital with a suspected mTBI within 12 hours of injury. A blood sample is drawn from the arm and sent to the lab for preparation and the test is run on the Alinity i instrument. Results are available in as little as 18 minutes and shared with the treating healthcare provider for evaluation.

Broadening the availability of the TBI blood test for use on lab-based instruments is an important step in Abbott's strategy to ensure its tests are available in all settings where people seek care for head injuries.

About Alinity i laboratory test for TBI

The Alinity i TBI test measures complementary biomarkers in blood plasma and serum - Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value.

Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers decide appropriate next steps and develop a plan to care for patients. The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.

The test previously received European Union clearance and has been available in markets outside the U.S. since 2021.

Source: https://abbott.mediaroom.com/2023-03-07-Ab...

Cognitive Functioning Improves After Cochlear Implant

Anyone ever tell you that you should get your hearing tested?  And it’s more than you just choosing to ignore some annoying person 😉?  Then maybe it would pay for you to actually get your hearing tested and get a hearing aid if you need one.  “But I don’t want to wear a hearing aid”.  Then prepared to get dumber.  

Lots of studies support that as sensory inputs start to waiver – poor eyesight, hearing, even taste – the cognitive decline accelerates as you age.  Who wants that?  

If you need a hearing aide – you need to get one (or two, more likely) and WEAR IT!  It might just make you smarter.

FROM MEDPAGE TODAY / BY JUDY GEORGE

Clinically meaningful improvement in older adults at risk for mild cognitive impairment

Cognitive functioning improved 12 months after cochlear implantation for older adults with severe hearing loss and poor cognition, data from a single-center study showed.

Among 21 cochlear implant candidates whose preoperative scores indicated mild cognitive impairment, overall cognitive scores improved 12 months after cochlear implant activation from a median percentile of 5 to 12 (difference of 7, 95% CI 2-12), reported Ellen Andries, MSc, of Antwerp University Hospital in Belgium, and colleagues.

Eight participants' scores improved enough to move them out of the mild cognitive impairment category (16th percentile), Andries and co-authors reported in JAMA Otolaryngology-Head & Neck Surgery.

Speech recognition in noise improved, which was tied to a rise in cognitive abilities.

The study is one of the first to examine cochlear implants among older adults with preoperative poor cognitive functioning, the researchers noted.

"Several large studies have previously demonstrated an improvement of cognitive functioning in severely hearing-impaired older adults after cochlear implantation, but few of these studies specifically analyzed participants achieving poor cognitive outcomes preoperatively," Andries told MedPage Today.

The findings suggest cochlear implantation is not contraindicated in candidates with cognitive decline and should be considered after a multidisciplinary evaluation, she noted.

"The management of modifiable risk factors for dementia, such as hearing loss, is important as there is currently no cure for dementia and its incidence is rising rapidly," Andries added. The top modifiable risk factoropens in a new tab or window for dementia prevention is hearing loss, which accounts for 8.2% of the global dementia burden, according to a recent Lancet Commission report.

The analysis included cochlear implant candidates 55 and older with poor baseline cognitive scores among participants in Antwerp University Hospital's larger prospective cohort study from April 2015 to September 2021. Median age was 72, and 62% were men. Speech processors were activated approximately 4 weeks after cochlear implantation surgery.

All participants had a preoperative total score on the Repeatable Battery for the Assessment of Neuropsychological Status for hearing-impaired patients (RBANS-H) that indicated mild cognitive impairment -- a score at least 1 standard deviation below the mean compared with age-appropriate normative data (16th percentile or lower).

The RBANS-H evaluates five cognitive subdomains: immediate memory, attention, language, visuospatial/constructional, and delayed memory. The test battery has alternate forms A and B; both were used to assess patients 1 month preoperatively and 12 months after speech processor activation.

Speech recognition in noise was measured with the Leuven Intelligibility Sentences Test. Anxiety and depression symptoms were identified using the Hospital Anxiety and Depression Scale (HADS) preoperatively and 12 months after activation.

Most participants (16 of 21) showed improvement in the RBANS-H total percentile 12 months after cochlear implant activation. The RBANS-H percentile remained stable in one participant and decreased in four.

Speech recognition in noise improved after activation (mean score 17.16 vs 5.67 on a scale where lower is better, for a difference of −11.49, 95% CI −14.26 to −8.72). Better speech recognition in noise was associated with significantly better cognitive functioning (rs −0.48).

Other variables, including years of education, sex, RBANS-H version, and depression and anxiety symptoms, were not related to changes in RBANS-H scores.

The findings support the information degradation hypothesisopens in a new tab or window as a potential explanation for the link between hearing loss and cognition, Andries and colleagues observed. "This hypothesis states that older adults with hearing loss need to rely more on cognitive resources to compensate for impaired auditory input, resulting in more mental fatigue and a higher cognitive load, which leads to a reduction of cognitive resources available for other cognitive tasks," they noted.

The study lacked a control group for ethical reasons, the researchers pointed out, and unknown factors like infection, medications, or pain could have influenced cognitive performance.

The small sample size was also a limitation, they acknowledged. "Further longitudinal research including a larger sample of cochlear implant candidates with cognitive decline is therefore recommended," they wrote.

Source: https://www.medpagetoday.com/neurology/dem...

Healthy Eating Linked to Lower Risk of Total Mortality

The headline, of course, is the hook – Health Eating Linked to Lower Risk of Mortality.  Great – eat “what you’re supposed to” and save lives.  Only, as usual, that’s really not the whole story.  So, boatloads of people (75k women, 44k men) over lots of years (up to 36 years) showed a risk reduction of between 14 and 20 percent, which would be good, EXCEPT this compares the “best” eaters against the “worst” eaters. 

Is it worth it to get crazy about your diet? That’s not really fair – the best diet is actually not only tolerable, but good.  It’s not at all a crazy diet,  but I have a different take on all of it (Surprised??).  Before we get to that, there are some other interesting things we should note.  Certain specific categories of disease have very different results – Lung disease (to me, surprisingly) is impacted the most, with a 35-46% risk reduction (that would mean if you have lung disease – PAY ATTENTION TO YOUR DIET!).  On the other hand, Stroke is unaffected, heart disease, cardiovascular disease and cancer deaths are reduced between 6 and 18%.  

What’s my take?  The food supply is screwed up, relatively depleted of nutrition and regardless of how well you adhere to the right plan, there’s more to do.  Whether that be vitamins or other supplements, exercise, stress reduction, etc – really reducing risk of disease and death requires attention and action.   For me, that means getting some data, analyzing the results and doing “stuff” to make a difference.  

Let’s chat to see if there’s something you might want to do to change your health trajectory!

Adhering to healthy eating patterns was associated with lower risk of total and cause-specific mortality, a prospective cohort study with up to 36 years of follow-up showed.

Among 75,230 women from the Nurses' Health Study and 44,085 men from the Health Professionals Follow-up Study, those who scored in the highest quintile for healthy eating patterns recommended by the Dietary Guidelines for Americans (DGAs) had a 14% to 20% lower risk of total mortality versus those in the lowest quintile, reported Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Internal Medicine.

The pooled multivariable-adjusted hazard ratios of total mortality with four healthy eating patterns were (P<0.001 for trend for all):

  • Healthy Eating Index 2015 (HEI-2015): HR 0.81 (95% CI 0.79-0.84)

  • Alternate Mediterranean Diet (AMED): HR 0.82 (95% CI 0.79-0.84)

  • Healthful Plant-Based Diet Index (HPDI): HR 0.86 (95% CI 0.83-0.89)

  • Alternate Healthy Eating Index (AHEI): HR 0.80 (95% CI 0.77-0.82)

This lower risk was consistent across all racial and ethnic groups.

"This is one of the largest and longest-running studies that examine the associations of dietary scores for four healthy eating patterns recommended by the DGAs with the risk of total and cause-specific mortality in large cohort studies," Hu told MedPage Today.

"Every 5 years, the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) release an updated version of the Dietary Guidelines for Americans," he explained. "It is important to evaluate adherence to DGA-recommended eating patterns and health outcomes, especially mortality, so that timely updating of DGAs can be made."

Hu noted that these findings will be valuable for the 2025-2030 Dietary Guidelines Advisory Committee, which is being created by the USDA and HHS to evaluate the current evidence on different eating patterns and health outcomes.

Beyond total mortality, healthier diets were also significantly linked to lower risk of cause-specific mortality.

Across the four different dietary patterns, people in the highest quintile saw a 6% to 13% lower risk of death from cardiovascular disease versus those in the lowest quintile. Likewise, those in the highest quintile saw a 6% to 15% lower risk of death due to heart disease, a 7% to 18% lower risk of cancer-related death, and a 35% to 46% lower risk of respiratory disease-related death.

In addition, those with the highest scores on the AMED and AHEI also saw a modestly lower risk of death due to neurodegenerative disease (HR 0.94, 95% CI 0.90-0.99 and HR 0.93, 95% CI 0.87-0.99, respectively).

"Although previous studies have found an inverse association between healthy eating patterns and mortality, our study provides evidence that healthy eating patterns reduce the risk of cause-specific mortality including cardiovascular disease, cancer, respiratory, and neurodegenerative mortality," said Hu. "The findings on respiratory and neurodegenerative mortality are novel."

However, eating a healthy diet according to any of the four patterns did not appear to be protective against stroke-related deaths.

Hu said clinicians can recommend a "variety of healthy dietary patterns" to patients in order to reduce their risk for chronic diseases and premature death.

"These patterns such as the Mediterranean diet, DASH diet, vegetarian diet, or other versions of healthy diets can be adapted to meet individual health needs, food preferences, and cultural traditions," he noted. "These healthy dietary patterns typically include high amounts of plant foods such as fruits, vegetables, whole grains, nuts, and legumes, and lower amounts of refined grains, added sugars, sodium, and red and processed meats."

"It is also important to balance caloric intake with physical activity to maintain a healthy weight," he added.

Among the women included in the analysis, mean baseline age was 50.2 and 98% were white; for men, mean age was 53.3 and 91% were white. In total, 31,263 women and 22,900 men died during follow-up. The leading cause of death was cancer, followed by cardiovascular disease, heart disease, neurodegenerative disease, respiratory disease, and stroke.

Dietary data were taken from semiquantitative food frequency questionnaires including more than 130 items, which were completed every 2 to 4 years.

Source: https://www.medpagetoday.com/primarycare/d...

Researchers Looking For Long COVID Symptoms Find Only 7

Let's get something clear that I don't think people actually know - COVID is a disease of blood vessels.  As such, it hits everything, hence a constellation of symptoms that covers the universe (get the astronomy reference?).  Also, while the mainstream suggests that there are no clear diagnostic criteria for Long Haul, there is plenty of evidence supporting specific blood tests (that we do) that ties directly to the symptoms and mirrors patients' experience. When you can fix the labs, you can fix the people.  Unfortunately, it can take a while, but it can be done.  Defining the problem remains a problem broadly, but that's why we're not doing mainstream medicine - we need to deliver solutions first.  

FROM FIERCE HEALTHCARE / BY FRANK DIAMOND

The Centers for Disease Control and Prevention’s tally of 19 possible long COVID symptoms comes with the caveat that it's “not a comprehensive list.”

Yale Medicine counts 22 symptoms, while the Mayo Clinic lists 10. And Great Britain’s National Health Service (NHS) puts the number at 16.

These lists can be made even longer. For instance, the NHS has “high temperature, cough, headaches, sore throat and changes to sense of smell or taste” as one symptom. Mayo lists “difficulty thinking or concentrating, headache, sleep problems, dizziness when you stand, pins-and-needles feeling, loss of smell or taste and depression or anxiety” as one symptom.

A major obstacle to helping patients with long COVID is that currently there are no generally agreed-upon diagnostic or treatment guidelines. Narrowing down exactly what symptoms point to long COVID would be a start, and researchers at the University of Missouri (MU) think they’ve done just that by slimming the field of long COVID symptoms down to just seven: fast-beating heart, hair loss, fatigue, chest pain, shortness of breath, joint pain and obesity.

Their study in Open Forum Infectious Diseases said that “understanding the population and subgroup risks for long COVID associated with outcomes, including lingering and chronic never-before-experienced symptoms and new medical diagnoses such as those reported here, is important for clinicians and researchers so that clinical guidelines for treatments and symptom management can be more appropriately developed for the growing number of adults affected by COVID-19.”

Chi-Ren Shyu, Ph.D., the director of the MU Institute for Data Science and Informatics and the corresponding author of the study, tells Fierce Healthcare that “understanding the population and subgroup risks for long COVID associated with outcomes, including lingering and chronic never-before-experienced symptoms and new medical diagnoses such as those reported here, is important for clinicians and researchers, so that clinical guidelines for treatments and symptom management can be more appropriately developed for the growing number of adults affected by COVID-19.”

Shyu and co-authors examined data from 52,461 patients collected in electronic health records at 122 healthcare facilities across the U.S. They identified 47 possible symptoms of long COVID. They compared symptoms in three groups:

  • Individuals who had COVID-19 but didn’t have common viral problems associated with the disease such as influenza or pneumonia.

  • Individuals who didn’t have COVID-19 but did have a different viral respiratory infection.

  • Individuals who had neither COVID-19 nor one of the other infections.

“Previous work has briefly investigated the differences in outcomes between hospitalized COVID-19 and influenza patients,” the study states. “Our work provides additional information on this subject by analyzing a larger and more diverse patient cohort, including other common viral respiratory infections, and examining outcomes in patient cohorts not limited to patients hospitalized for the initial infection.”

The authors said they hope their findings will point out what symptoms clinicians should look for when trying to determine whether somebody has long COVID. “A better recognition of post COVID syndrome or long COVID will help us study the underlying reasons that cause these prolonged abnormalities and also help us develop screening protocols to be used when COVID-19 survivors are seen within the healthcare systems,” says Shyu. “Such recognition also helps in developing focused treatments and rehabilitation strategies to promote recovery.”

Adnan Qureshi, Ph.D., a professor of neurology at the MU School of Medicine and co-author of the study, notes in a press release that the “survivors still have symptoms that are at times disabling and preventing them from going back to work or the activities of their daily life. This is not because the COVID-19 infection is still active, but instead, the infection has caused long-term consequences, or sequelae, in the form of a post-COVID syndrome that could persist for months or even years. Our research was able to identify long-term sequelae that are distinctive to COVID-19 and separate the post-COVID syndrome from other post-viral syndromes.”

One symptom of long COVID that their study found bolsters the findings of previous studies that linked the condition to heart problems.

Source: https://www.fiercehealthcare.com/providers...

UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings.

Probably everyone looking at this says “yeah, right”.  I’d bet virtually everyone has a story of their own, or a friend’s where the insurance company said no for some reason that, to the general public would seem absolutely absurd – because it was!  Recently I had a patient with Long Covid who was still suffering from fatigue, brain fog (he just started treatment) who was told by his insurance company that they would no longer be paying his disability so he could limit his work to two days a week.  We had tests that showed his executive function was slowed (he needed to be able to make split-second decisions or people could literally die), and was dependent on his dominant hand whose function also tested as well below normal.  On the limited schedule he could manage to avoid the potential disasters, but they wanted him back full-time.  Appeals didn’t matter.  Ultimately he retired, so the insurance company won all around.  

I have many stories.  Once in a very long while we can win.  But it's a sad state of affairs. 

After a college student finally found a treatment that worked, the insurance giant decided it wouldn’t pay for the costly drugs. His fight to get coverage exposed the insurer’s hidden procedures for rejecting claims.

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis — an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Kavanaugh replied.

UnitedHealthcare Employees Discuss the Denial of Chris McNaughton’s Claim

David Opperman is an insurance broker who works for UnitedHealthcare. Victoria Kavanaugh is a nurse for United. In this recorded phone call from 2021, the two express relief that a doctor has turned down Penn State student Chris McNaughton’s claim as “not medically necessary.”

Opperman then complained about McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for McNaughton's treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America's leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed FDA guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with McNaughton. In emails, officials calculated what McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Kavanaugh said of McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”

The Same Meal Every Day

Now 31, McNaughton grew up in State College, Pennsylvania, just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For two years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring McNaughton to Dr. Edward Loftus Jr. at the Mayo Clinic in Minnesota, which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Loftus in May 2015, McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the five-minute walk from the hotel to the clinic. When they met, Loftus looked at McNaughton and told him that he appeared incapacitated. It was, he told the student, as if McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Loftus treated him.

In addition to trying to find a treatment that would bring McNaughton’s colitis into remission, Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection and fatigue. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Loftus and McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases like colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

McNaughton receives an infusion of medication to treat his ulcerative colitis at a medical facility in State College. After initially paying for his treatment, UnitedHealthcare began rejecting his insurance claims. Credit:Nate Smallwood, special to ProPublica.

McNaughton had tried individual biologics, and then two in combination, without much success. He and Loftus then agreed to try two biologic drugs together at doses well above those recommended by the U.S. Food and Drug Administration. Prescribing drugs for purposes other than what they are approved for or at higher doses than those approved by the FDA is a common practice in medicine referred to as off-label prescribing. The federal Agency for Healthcare Research and Quality estimates 1 in 5 prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Loftus has been paid to do consulting related to the biologic drugs taken by McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctor’s expertise and experience with the drug.“In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Loftus said.

There was evidence that the treatment plan for McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose — to reduce inflammation in the large intestine — but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for McNaughton was out of bounds or dangerous, Loftus said “my treatment of Chris was not clinically inappropriate — as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to three or four. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, McNaughton was covered under his family’s plan, and all his bills were paid. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by McNaughton would be covered by United.

McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive McNaugton of treatment that they considered miraculous.

They turned to Penn State for help. Light and McNaughton’s father, David, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Kavanaugh, the nurse, said in a recorded conversation.

Victoria Kavanaugh Complains to a United Contractor That McNaughton’s Coverage Request Is “Insane”

McNaughton had been on the treatment for three years and it had put his disease in remission with no side effects.

The family’s relief was short-lived. A month later, United started another review of McNaughton’s care, overseen by Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

Victoria Kavanaugh Describes Penn State as a “Big Account for Us”

On a call with an outside contractor, the United nurse claimed McNaughton was on a higher dose of medication than the FDA approved, which is a common practice known as “off-label prescribing.”

MRIoA sent the case to Dr. Vikas Pabby, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of McNaughton’s case was just one of more than 300 Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021 report, Pabby concluded McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Opperman and Kavanaugh agreed that if McNaughton were to appeal Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Opperman said, according to a recording in court files. At Opperman’s urging, United decided to skip the usual appeals process and arrange for Pabby to have a so-called “peer-to-peer” discussion with Loftus, the Mayo physician treating McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually only occurs after a customer has appealed a denial and the appeal has been rejected.

When Kavanaugh called Loftus’ office to set up a conversation with Pabby, she explained it was an urgent matter and had been requested by McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Loftus told Pabby that McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Loftus, Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Kavanaugh shared the May 12 decision from Pabby with others at United, her boss responded with an email calling it “great news.”

Then Opperman sent an email that puzzled the McNaughtons.

In it, Opperman claimed that Loftus and Pabby had agreed that McNaughton should be on significantly lower doses of both drugs. He said Loftus “will work with the patient to start titrating them down” — or reducing the dosage — “to a normal dose range.” Opperman wrote that United would cover McNaughton’s treatment in the coming year, but only at the reduced doses. Opperman did not respond to emails and phone messages seeking comment.

McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to McNaughton was that the treatment United said it would now pay for was dramatically cheaper — saving the company at least hundreds of thousands of dollars a year — than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Loftus for an explanation, they were outraged by what they heard. Loftus told them that he had never recommended lowering the dosage. In a letter, Loftus wrote that changing McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Loftus’ conversations had been so seriously misrepresented.

Under questioning by McNaughton’s lawyers, Kavanaugh acknowledged that she was the source of the incorrect claim that McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Opperman’s inaccurate report of the phone call with Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”

A Buried Report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Dr. Nady Cates, for an additional review. The review was marked “escalated issue.” Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn't a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of McNaughton’s case.

Dr. Nady Cates, a United Medical Director, Explains That He Copied and Pasted the Text of His Decision to Deny McNaughton’s Care

In the deposition, Cates tells McNaughton’s lawyer that he copied the recommendation of Pamela Banister, a nurse for United, rather than writing his own decision.

Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that McNaughton had failed other treatments or that Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Cates in his deposition. He responded, “Yeah.”

Attempts to contact Cates for comment were unsuccessful.

At the same time Cates was looking at McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Dr. Nitin Kumar, a gastroenterologist in Illinois, concluded that McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Kumar discussed the harm that McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Kavanaugh learned of Kumar’s report, she quickly moved to quash it and get the case returned to Pabby, according to her deposition.

In a recorded telephone call, Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Pabby. “I appreciate that,” Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Pabby again rejected McNaughton’s treatment plan. While noting it was “difficult to control” McNaughton’s ulcerative colitis, Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Kavanaugh said that after she opened the Kumar report and read that he was supporting McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Pabby for review.

Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that McNaughton risked cancer or hospitalization if his regimen were changed, Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Kavanaugh was correct in insisting that Pabby conduct the review and that MRIoA confirmed that Pabby should have been the one doing the review.

The Kumar report was not provided to McNaughton when his lawyer, Jonathan Gesk, first asked United and MRIoA for any reviews of the case. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Kavanaugh mentioned a report number Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.

A Sense of Hopelessness

When McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous six years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

McNaughton and his parents talked about him possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Loftus connected McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, said McNaughton was not an unusual case. About 1 in 3 patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of McNaughton, Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Taft said. The physical and mental symptoms McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would only pay for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Loftus, according to an email sent by United’s lawyer.

The Cost of Treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the U.S. is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of McNaughton’s care was front and center at United.

In one email, Opperman asked about the cost difference if the insurer insisted on only paying for greatly reduced doses of the biologic drugs. Kavanaugh responded that the insurer had paid $1.1 million in claims for McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on McNaughton at the highest levels of the company. On Aug. 2, 2021, Opperman notified Truxal and a United lawyer that McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than two decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.

“Betrayed”

McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting McNaughton’s claims into pending status.

McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give — with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Klinger’s salary, an arrangement which is not noted on the university website. Klinger appears in the online staff directory on the Penn State University Health Services webpage, and has a university phone number, a university address and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Klinger was now a full-time employee of United.

“We did feel betrayed,” Light said. Klinger did not respond to an email seeking comment.

McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to reenroll in the United health care plan when he starts school next fall.

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

Effect of Food Order on Ghrelin Suppression

Some years back a study was done comparing how one ate the same meal made a difference is your metabolism.  Now a more specific evaluation on one of the components of that metabolism was evaluated and found to be affected in no surprise.  I thought, though, this gave me an opportunity to review the earlier information, because it’s just SO important for everyone to understand.  

You go into a nice Italian restaurant, and they have great bread.  You love the bread, but you figure you’re watching your diet, so you’ll only have the bread – no oil or butter.  WRONG!!  Literally, the worst thing you can do.  Why?  

Restaurants know from years of experience, giving bread before the meal MAKES PEOPLE ORDER MORE FOOD.  Turns out that the carbohydrate load minutes before consuming any other macronutrient (think protein, fat, carbs) will drive up your blood sugar to astronomical heights, and thus driving up insulin levels, and that elevation will persist for hours.  This combination leads to “overeating”.  You’re priming the pump for pre-diabetes.

If start the meal with bread AND butter or olive oil, that fat will actually work in your favor to slow the carbohydrate absorption, blunt your sugar elevation, blunt your insulin response, which results in 40% lower levels and a far lower chance of driving that pre-diabetes story.  

Now, of course, if you eat all the bread, all the food, and the dessert, all bets are off!  But if you want to have a piece of that delicious bread, do yourself a favor – dip it in some olive oil, or if they have really good, yellow butter (like Kerry Gold), go for it!  

Now THAT’S A CRAZY STORY!  (but true 😉)

FROM DIABETES CARE / BY ALPANA P. SHUKLA, ELIZABETH MAUER, LEON I. IGEL, WANDA TRUONG, ANTHONY CASPER, REKHA B. KUMAR, KATHERINE H. SAUNDERS, LOUIS J. ARONNE

Data suggest that the temporal sequence of carbohydrate ingestion during a meal has a significant impact on postprandial glucose 1-3), insulin, and glucagon-like peptide 1 (GLP-1) excursions (4) in type 2 diabetes, while the effects on ghrelin suppression and satiety have not been reported.

The study design and methods have previously been described in detail (4). Briefly, using a crossover design, 16 subjects with overweight/obesity and metformin-treated type 2 diabetes were assigned to consume the same meal on 3 days in random order:

  • Carbohydrate-first meal: carbohydrate (bread and orange juice), followed 10 min later by protein (chicken) and vegetables

  • Carbohydrate-last meal: protein and vegetables, followed 10 min later by carbohydrate

  • Sandwich: all meal components together, each half consumed over 10 min with a 10-min interval in between

Blood was sampled for glucose, insulin, active GLP-1, and total ghrelin measurements at baseline (just before meal ingestion) and at 30-min intervals up to 180 min. Participants rated their hunger and fullness levels using a visual analog scale (VAS) at the same time points.

Baseline glucose, insulin, GLP-1, and ghrelin concentrations, as well as hunger and satiety scores, were similar in the three meal conditions. At 180 min, ghrelin levels remained suppressed following the carbohydrate-last meal order, while the carbohydrate-first meal led to a rebound in ghrelin to preprandial levels (percent ghrelin change from baseline to 180 min −11.45 ± 3.86% vs. 4.13 ± 4.38%; P = 0.003) (Fig. 1). Decremental areas under the curve for 0–180 min were similar in the three meal conditions. There was an inverse correlation between percent change in ghrelin and percent change in glucose from baseline when assessing all participants in the three meal conditions at the evaluated time points (r = −0.204; P < 0.001). We did not observe a significant effect of food order on subjective VAS appetite measures.

Ghrelin percent change from baseline following carbohydrate-first (carbs first), carbohydrate-last (carbs last), and sandwich meal orders. Values are mean ± SEM, n = 16. ¥Statistically significant difference (P = 0.003, linear mixed-effects model) between carbs first and carbs last at 180 min.

We have previously demonstrated that the carbohydrate-last meal pattern reduces postprandial glucose excursions compared with other meal patterns. Controlling for carbohydrate amount, this meal pattern stimulates lower insulin and higher GLP-1 response compared with the carbohydrate-first pattern (4). Taken together with our new findings on ghrelin suppression, this suggests that macronutrient order during a meal modifies the pattern of postprandial insulin and gut hormone secretion that could potentially impact satiety and weight regulation. However, similar to observations in previous studies that have investigated gut hormone excursions to isocaloric meal interventions (5,6), these disparate hormonal responses did not translate into any significant differences in hunger/satiety scores reported by participants in the three meal conditions. This result may reflect both the subjective nature of the VAS tool and the complexity of appetite regulation; ghrelin is the only known orexigenic peptide, whereas GLP-1 is one of several anorexigenic signaling gut hormones. Further study with an extended observation period, assessment of other gut hormones using meals with different macronutrient composition, and more objective measures of satiety is needed.

In conclusion, to our knowledge, this is the first study to demonstrate that manipulation of macronutrient order can impact gut hormone excursions. Its clinical implications for satiety and weight management require further study.

Source: https://diabetesjournals.org/care/article/...

Dementia Tied to Hearing Loss

It’s well known that losing senses translates to increased incidence of dementia.  It seems like losing contact with one’s environment translates into accelerated loss of a functional brain.  Think about kids who don’t get stimulated adequately – they end up being delayed or cognitively impaired.  Same thing ends up happening at the other end – less stimulation ends up in the idea of “use it or lose it”.  Your brain starts to deteriorate at a faster rate if it’s not getting “poked” regularly.  This happens as eyesight fails (cataracts contribute to dementia), social isolation, and hearing loss.  The important finding here, though, is that hearing aids actually drops that risk back to a usual level, and might actually decrease the risk of developing dementia slightly.  You hear what I’m saying? 😉

If you hear yourself saying “what?” a bunch, get your hearing checked and get some hearing aids.  If your vision is failing, get it checked and maybe get your cataracts fixed.  Don’t sit home alone – make some friends!  All these simple things could really save you. 

— Likelihood of developing dementia was lower for older adults who used hearing aids

Moderate-to-severe hearing loss was linked with a higher prevalence of dementia, a cross-sectional study of Medicare beneficiaries showed.

Among 2,413 older adults in the National Health and Aging Trends Study (NHATS), dementia prevalence among people with moderate-to-severe hearing loss was higher than it was among people with normal hearing (prevalence ratio 1.61, 95% CI 1.09-2.38), reported Nicholas Reed, AuD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues.

But among people with moderate-to-severe hearing loss in the study, hearing aid use was associated with a lower prevalence of dementia compared with no hearing aid use (prevalence ratio 0.68, 95% CI 0.47-1.00), they wrote in a JAMA research letter.

The findings support a recent systematic review and meta-analysis that showed treating hearing loss led to cognitive benefits. They also support the availability of over-the-counter hearing aids, which people with mild-to-moderate hearing loss now can purchase directly due to new regulations.

Reed and colleagues used data from the continuous NHATS panel study of Medicare beneficiaries. The NHATS cohort was oversampled for age (53.3% were 80 or older) and race (18.8% were Black). Participant information collected through in-home interviews.

Hearing was assessed with a portable audiometer. Researchers calculated a pure tone average in the better-hearing ear as the mean of four frequencies -- 500, 1,000, 2,000, and 4,000 Hz -- most important for understanding speech.

Normal hearing was defined as a pure tone average of 25 dB or less, mild hearing loss was 26-40 dB, and moderate-to-severe loss was over 40 dB. About a third of participants (33.47%) had normal hearing after weighting; 36.74% had mild hearing loss, and 29.79% had moderate-to-severe loss. People with moderate-to-severe hearing loss tended to be older, male, and white, and had less education than others.

The weighted prevalence of dementia was 10.27% overall. Dementia prevalence rose as severity of hearing loss increased: for normal hearing, it was 6.19%; for mild hearing loss, it was 8.93%; and for moderate-to-severe hearing loss, it was 16.52%.

The study's cross-sectional design was a limitation. In addition, nursing home and residential care residents were excluded from the analysis because the researchers did not have cognitive data about them.

The top modifiable risk factor for dementia prevention is hearing loss, which accounts for 8% of the global dementia burden according to a recent Lancet Commission report.

"This study refines what we've observed about the link between hearing loss and dementia, and builds support for public health action to improve hearing care access," co-author Alison Huang, PhD, also of Johns Hopkins, said in a statement.

How hearing loss is linked to dementia isn't clear and studies point to several possible mechanisms. "Mediation analyses to characterize mechanisms underlying the association and randomized trials to determine the effects of hearing interventions on reducing dementia risk are needed," Reed and colleagues wrote.

Information about hearing loss treatment and cognition from the 3-year randomized ACHIEVE trial is expected later this year.

Source: https://www.medpagetoday.com/neurology/dem...