'Unexpected Bonus Benefit With Lifestyle Intervention in Type 2 Diabetes'

 An intensive lifestyle intervention (ILI) designed to prevent the progression and complications of type 2 diabetes was associated with boosted employment rates, according to an ancillary study of the Look AHEAD (Action for Health in Diabetes) randomized trial.

Among a total of 3,091 adults, employment rates increased 2.9% (95% CI 0.3-5.5, P=0.03) for those in an ILI program compared with controls, who received group-based diabetes education, reported Peter Huckfeldt, PhD, of the University of Minnesota School of Public Health in Minneapolis, and colleagues.

"These effects are commensurate to the ILI's effects on weight (8% reduction in the first year of the trial), physical fitness (10% increase in metabolic equivalents in the first 4 years of the trial), and mobility loss (48% reduction in the first 4 years of the trial)," they wrote in JAMA Internal Medicine

opens in a new tab or window.

"A previous cost-effectiveness analysisopens in a new tab or window of Look AHEAD (focused on health utility and health care spending) found mixed evidence for whether the benefits of the ILI justified the costs," they explained. "Our findings imply that the ILI had benefits in terms of employment and disability benefit receipt that are not captured by typical cost-effectiveness frameworks, although overall effects on earnings and disability payments were statistically insignificant."

The link between the ILI and employment appeared to be driven by people who did not have a college degree. For these individuals, there was a 5.2% higher employment rate for those who participated in the ILI. This group also saw significantly lower disability benefit receipt (-2.2%) and lower disability benefit payments ($-365).

While employment rates were higher for those who participated in the ILI, overall earnings didn't differ between the groups. The percentage of people who received disability benefits was also not significantly different between the groups, the researchers noted.

None of these outcomes -- employment, earnings, or disability receipt and payments -- were different between the groups for people with at least a college degree.

Involving a combination of lifestyle counselors, dietitians, exercise specialists, and behavioral therapists, the ILI program consisted of one-on-one weekly sessions for the initial 6 months. After that point, participants had monthly sessions, which continued through the fourth year, which then turned into annual sessions. The goal was to achieve and maintain at least a 7% weight loss; a 5% weight loss is the threshold considered clinically significant. The control group had three group sessions in the first 4 years followed by annual sessions.

This analysis was conducted as an ancillary study to the Look AHEAD randomized clinical trialopens in a new tab or window, which included people with type 2 diabetes and overweight or obesity. Huckfeldt's group linked the trial data with Social Security Administration records to measure outcomes in the labor market outcomes during and after the intervention period.

A total of 1,559 adults participated in the ILI and 1,532 were in the control group. The average age was 58, baseline BMI was 36, and the average duration of diabetes was 6.5 years. Around 43% were college graduates.

"Labor market productivity should be considered when evaluating interventions to control chronic diseases," the researchers suggested.

Disclosures

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute on Aging.

Huckfeldt reported grant funding from the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, the Agency for Healthcare Research and Quality, the Robert Wood Johnson Foundation, and the Centers for Medicare & Medicaid Services. Co-authors also reported disclosures, including ties with industry.

Primary Source

JAMA Internal Medicine

Source Reference: opens in a new tab or windowHuckfeldt PJ, et al "Association of intensive lifestyle intervention for type 2 diabetes with labor market outcomes" JAMA Intern Med 2023; DOI: 10.1001/jamainternmed.2023.3283.

https://www.medpagetoday.com/endocrinology/diabetes/105873

China must act to prevent epidemics in flood-hit Heilongjiang - vice premier Liu

 China must act to prevent epidemics from breaking out in flood-hit areas of the country such as Heilongjiang and ensure a smooth return to agricultural production, state news agency Xinhua quoted vice premier Liu Guozhong as saying on Monday.

Damaged farmland, water conservation and other infrastructure will need to be quickly repaired to ensure a speedy recovery in grain production, Liu was quoted as saying.

Liu made the remarks while visiting the northeastern province of Heilongjiang where floods have swamped farmland, affecting hundreds of thousands of people in the past few days.

The country has had an unusually wet and rainy summer season with massive flooding in its northern and northeastern provinces, such as in Hebei where more than 1.5 million people had to be evacuated in early August.

"It is necessary to implement various assistance measures for people who have been lifted out of poverty (but have been) affected by the disaster, and resolutely prevent the return to poverty on a large scale," Xinhua quoted Liu as saying.

Some villages remain flooded with poor water quality and a polluted environment posing a risk of infectious diseases occurring, Liu said, according to Xinhua.

"It is necessary to strengthen publicity and education on health and epidemic prevention," Liu said, including strictly monitoring drinking water quality and food hygiene testing.

Autumn grain in areas not affected by the disasters is growing well, Liu said, adding that it was necessary to increase the yield of major grain and oil crops across a large area to boost production.

https://www.marketscreener.com/news/latest/China-must-act-to-prevent-epidemics-in-flood-hit-Heilongjiang-vice-premier-Liu--44609012/

Joint cut to Hold from Buy by Maxim

 Target to $15 from $12

https://finviz.com/quote.ashx?t=JYNT&ty=c&ta=1&p=d

RVL update on business review

  UPNEEQ® remains a significant potential value driver given its rapid early acceptance by providers, large total addressable market and untapped consumer opportunity --

-- Executed financing amendment with Athyrium, which, subject to certain conditions, would provide meaningful flexibility as part of our ongoing strategy to invest in UPNEEQ and drive growth --

-- The Company is in discussions with strategic targets that could accelerate UPNEEQ sales, broaden the Company’s portfolio and leverage the field force investment --

-- Second quarter 2023 UPNEEQ net product sales of $8.3 million and operating expenses of $14.4 million, down 2% and 32%, respectively, compared to the prior year period, highlighting lower baseline of operating expense --

-- The Company streamlined operating expense in order to extend runway, optimize marketing mix, and support strategic business development --

-- Initiated creative development for our 1st Branded Direct-to-Consumer (“DTC”) campaign --

-- E-Commerce platform, Elevate, rollout on track –

https://finance.yahoo.com/news/rvl-pharmaceuticals-plc-reports-second-105000007.html

Judge In Trump J6 Trial Worked At Law Firm in Russia Hoax’s Fusion GPS, Tied To Hillary's Emails

 by Mark Pellin via Headline USA,

U.S. District Judge Tanya S. Chutkan, who is overseeing the Trump J6 trial being prosecuted by the Biden Justice Department, previously worked at a law firm that represented Fusion GPS, the company that helped orchestrate the Russia collusion hoax targeting former President Donald Trump.

During Chutkan’s stint with Boies Schiller Flexner, the Democrat-friendly law firm also reportedly represented Clinton Cabal foot soldier Huma Abedin, the former wife of disgraced Democrat Anthony Weiner.

The stunning revelations came in the wake of reports that the Obama-appointed judge worked at the same Boies Schiller Flexner law firm with President Joe Biden’s embattled son, Hunter. The same law firm that employed Chutkan also reportedly represented Burisma.

Trump blasted the apparently gross conflicts of interest and bias saddling Chutkan, writing on Truth Social that, “The Obama appointed Judge in  the FREE SPEECH Indictment of me by my political opponent, Crooked Joe Biden’s Department of InJustice, shared professional ties at the law firm that worked for Energy Company Burisma, based in Ukraine, of which Hunter Biden and his associate were “proud” MEMBERS OF THE BOARD, and were paid Millions of Dollars, even though Hunter knew almost NOTHING about Energy. How much was the law firm paid? So Horrible. This is a CLASSIC Conflict of Interest!”

The J6 free speech trial won’t be the first time Chutkan has been entangled by court conflicts stemming from her legal workings with outfits targeting Trump.

Chutkan was forced to recuse herself from the bench when she was overseeing Fusion GPS’s attempt to block former congressman Devin Nunes and Kash Patel from outing the source of payments that funded the infamous Steele dossier.

“Fusion GPS, the DNC, and the Hillary Clinton campaign paid Christopher Steele millions of dollars and they laundered it through the FBI and the FISA court to unlawfully surveil Donald Trump. That’s big-time stuff,” Patel, who served in the Trump administration, noted during an interview with America First’s Sebastian Gorka.

After months of litigation before Chutkan, when it became apparent that Nunes and Patel would be successful, “she recused -on her own- from that case. Why?” Patel asked rhetorically.

“We found out her law firm, Boies Schiller, represented Fusion GPS,” Patel answered. “The very client that was in front of her in federal court was one of her former clients. That is rule #1 for disqualification.”

It also sets a sterling precedent for Chutkan’s removal from the Trump J6 trial, Patel said.

“She set the precedent. She cannot neutrally and arbitrarily preside over Donald Trump’s criminal trial when she recused herself from the very representation of the Democratic entrenchment: the DNC, the Hillary Clinton campaign, Fusion GPS, because she was so biased because of her prior representation from Boies Schiller,” he argued.

https://www.zerohedge.com/political/judge-trump-j6-trial-worked-law-firm-repped-russia-hoaxs-fusion-gps-tied-hillarys-emails

ICG: Progress Advancing Its Lead Alzheimer’s Candidate Through Phase 2

  IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the quarter ended June 30, 2023, which is the first quarter of the Company’s 2024 fiscal year.

First Fiscal Quarter 2024 Highlights

• Net revenue increased 161% to approximately $555 thousand in the three months ended June 30, 2023, compared to $212 thousand in the prior year period, driven primarily by the sale of formulations based on the Holief brand natural products targeting women with premenstrual syndrome (“PMS”), period pain, and sleep disorders.
• Throughout the quarter, IGC Pharma maintained substantial momentum in the development of a Phase 3 manufacturing facility located on the West Coast, including augmentation of distillation capacity. The facility will enhance the Company’s ability to manufacture IGC-AD1 for Alzheimer’s, at scale, positioning IGC Pharma for the next phase of growth and advancement, although there can be no assurance. As the Company charts a strategic course towards eventual commercialization of its Alzheimer’s investigational pharmaceutical drug, the facility plays a pivotal role in generating incremental revenue through the production of over-the-counter products like Holief.
• On June 30, 2023, IGC Pharma secured $12 million line of credit from a Hong Kong-based bank to support working capital needs primarily related to Alzheimer’s research.
• On June 30, 2023, IGC Pharma entered into a stock purchase agreement with several investors for $3 million in gross proceeds further strengthening working capital and supporting the advancement of Phase 2 trials for IGC-AD1 in Alzheimer’s. This amount is not reflected on the balance sheet as of June 30, 2023, as the proceeds were received after the close of the quarter.
• On June 6, 2023, IGC Pharma received notice of allowance from Commissioner of Patents, Canada, for the Company’s patent filing on the use of cannabinoids in the treatment of seizures, IGC-501 (#2961410). The formulation also received an intent to grant from the European Patent Office.

https://www.biospace.com/article/releases/igc-pharma-reports-first-quarter-results-company-continues-to-make-significant-progress-advancing-its-lead-alzheimer-s-candidate-through-phase-2-clinical-trials/

'I was suicidal on Ozempic — it’s not a miracle weight-loss drug for everyone'

 Amelia had been intent on losing weight most of her life — but this concern had never caused the 35-year-old to consider ending her life.

Last summer, the Canadian woman was diagnosed with type 2 diabetes and prescribed the wildly popular “miracle” drug Ozempic (semaglutide) by her doctor, who presented the drug as an easy way for Amelia to shed a few pounds and manage her blood sugar.

Amelia, who asked that her last name be withheld for privacy reasons, avoided filling the prescription for three months since she “didn’t want to focus on the number on the scale.” However, she agreed to begin the weekly injections — which cost as much as $1,350 a month — after finding people online discussing how the drug helped them maintain their glucose levels.

“I didn’t have any mental health issues when I started Ozempic — and then the suicidal ideation just kind of came out of nowhere a couple months after starting it,” the financial analyst and mother of one told The Post of her experience with the extraordinarily in-demand drug.

Amelia’s darkest thoughts eased after a few months but her anxiety worsened and she began to spiral.

“Once my anxiety ramped up in February, my appetite dropped and that’s when I started becoming obsessed. It was just nonstop thinking about food in terms of not eating enough,” she said. “I’d be so stressed out because I had no appetite and then I wasn’t eating, which caused my anxiety to get worse and I started to feel guilty about how little I was eating. It was just like a continuous vicious cycle.”

“Semaglutide is produced while we eat; it tells the brain that we are full,” Dr. Katherine H. Saunders, a New York City physician, told The Post. “It helps people to feel less hungry, to feel full faster, and to stay full longer — but it does so when we are actually less full.”

REUTERS

Despite increasingly mainstream, celebrity-hyped usage, Ozempic and similar injectables have led to a spike in ER visits. The long list of disturbing side effects includes prematurely aging faces and drooping butts, spontaneous diarrhea while sleeping and stomach paralysis. Ozempic is also noted for its ability to stop food fantasies, or, as some on social media have dubbed them, “food noise.”

“So many people praise the aspect of quieting the ‘food noise,’ whereas for me that caused me so much mental stress,” Amelia said. “It almost became obsessive. Like, every day I would spiral and was constantly thinking about how little I was eating, and how terrible that made me feel.”

She eventually turned back to social media to find validation — and discovered others who claimed to also have experienced anxiety, depression and suicidal ideation with taking Ozempic.

The US Food and Drug Administration’s adverse event reporting system received 190 reports of depression and suicide-related mental illnesses connected to Ozempic, along with 84 reports connected to Saxenda and 26 to Wegovy as of June 30.

Meanwhile, European drug safety regulators officially launched an investigation of Ozempic, Saxenda and Wegovy after patients reported that the medicine triggered thoughts of suicide and self-harm.

 All three drugs are manufactured by Novo Nordisk. A representative for the pharmaceutical company said “Novo Nordisk remains committed to ensuring patient safety,” however, “the safety data collected from large clinical-trial programs and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”

Amelia eventually addressed her concerns with her doctor and insisted on a lower dosage. Since switching to the lowest possible amount in June, Amelia told The Post her appetite returned and her mental health drastically improved.

The FDA requires that medications for weight management that work on the central nervous system, including Saxenda and Wegovy, carry a warning about suicidal thoughts. Ozempic, which is only FDA-approved to treat diabetes, does not come with that warning. 

Although Saxenda warns users of the possible mental health side effects, Leigh — a 27-year-old special education teacher who spoke to The Post — was not prepared for the extent of the impact. The Philadelphia native was shocked at how the change in her relationship with food altered her mental state.

Leigh told The Post the drug, which she was prescribed to manage her weight, “completely took the pleasure out of food,” shrinking her appetite and making most foods seem undesirable or nauseating.

“People put so much emotion and hope into weight loss,” Dr. Alexis Conason, a licensed psychologist in NYC, told The Post. “And are sold this fantasy that if they just lose weight everything’s gonna be okay and all the good things that they want in life will come when they lose weight.”

NY Post composite

“When you’re really desperate to lose weight you think, ‘Oh, I wish I didn’t have pleasure from food’ and ‘I wish that I didn’t love food so much like that would be so great. Then I could just, like, not eat that much and all the weight would fall off.’ But the second that that pleasure is taken away, that’s not what you want,” she insisted.

Leigh said she felt a lot of shame for taking a medication to lose weight, hiding it from her friends and lying to her family that she had a medical condition that required the prescription.

“I was blaming myself like, ‘Oh, my God, I let myself gain so much weight that this is what I have to do to my body,” she admitted. “I felt like this was a last resort.”

Two months into taking the daily injections, Leigh nearly quit her job, was avoiding hanging out with her friends and “never wanted to do anything.” Her family and boyfriend eventually expressed their concern and Leigh decided to stop taking the medication and work on intuitive eating with a nutritionist. She’s already feeling much better.

While many people are surprised by the connection between these medicalized weight loss and mental health, medical experts are not.

Research has shown that bariatric surgery patients have an increased risk for suicide and self-harm behaviors following the procedure. Lead study author Dr. Alexis Conason, a licensed psychologist in NYC, noted that triggering experiences such as changes in quality of life and unrealistic expectations also occur to those going through other weight loss treatments such as Ozempic.

“People put so much emotion and hope into weight loss, and are sold this fantasy that if they just lose weight everything’s gonna be okay and all the good things that they want in life will come when they lose weight,” Conason told The Post.

It can be devastating when that doesn’t happen.

“It’s not necessarily surprising when you see there may be an increase in suicidal ideation and other things like that because you’ve taken away a really important coping mechanism for many people,” Brooke Boyarsky Pratt, CEO and co-founder of weight-inclusive care company Knownwell, told The Post.

A shortage of Wegovy is making it hard for diabetics to get their meds in a timely manner — as more employers are cutting off insurance coverage for costly the weight-loss drugs, which can cost up to $1,350 a month.

REUTERS

Dr. Gregory Dodell of Central Park Endocrinology also noted that patients on medications that suppress their appetite may not be getting sufficient nutrients, which in turn disrupts their mental stability.

“So much of balancing our body is about what we eat and drink,” he told The Post.

That’s why some experts, including Dr. Angela Fitch, president of the Obesity Medicine Association, recommend patients taking medications that result in weight loss seek comprehensive care, monitor both physical and mental health and be fully educated on realistic expectations and all possible side effects.

“Setting expectations and weight management is a huge problem in our country,” Fitch told The Post.

https://nypost.com/2023/08/14/i-was-suicidal-on-ozempic-its-not-a-miracle-weight-loss-drug-for-everyone/