Team Metabolic Health

Through real-world data, an AI company found that popular weight loss drugs could be a preventive measure for patients at risk of heart attack and stroke.

Novo Nordisk got a major boost in March when the FDA approved its GLP-1 diabetes and weight loss drug Wegovy to also prevent heart attacks and strokes in patients with certain risk factors. The decision opened the market up to more than six million people and broadened Medicare coverage for the blockbuster drug, now on track to become one of the best-sellers of 2024.

And that may only be the tip of the iceberg, according to a sweeping AI study from Dandelion Health, which identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment, hinting at the potential to greatly expand insurance coverage.

Scott Olson via Getty Images

Putting AI to work

Dandelion leaders ran the study as a proof-of-concept test of their real-world data platform, which uses commercial and academic AI programs to analyze patient information obtained through revenue-sharing agreements with health systems, including Sanford Health, Sharp HealthCare and Texas Health Resources. The platform could be a faster and less expensive way to deliver results than traditional clinical trials. Studies could take weeks, not years, and incorporate larger and more diverse patient groups, according to the company’s co-founder and CEO, Elliott Green.

“No one ever does preventative trials because they’re just too big,” he said. “But this AI proof-of-concept started to show that there’s a path forward to being able to achieve that.”

Mining real-world data

For the observational study, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients. The study used inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits. But, unlike SELECT, Dandelion’s patient group didn’t have severe preexisting cardiovascular disease.

Researchers applied an AI algorithm from Pheiron trained to spot cardiovascular risk indicators on patient electrocardiograms. The AI assigned patients a risk score and compared predicted risk for heart attacks and strokes in GLP-1 users versus non-users. The results expanded on the findings of Novo’s trial, which found Wegovy reduced the risk of major cardiac events in the study group as much as 20%. 

Bottom of Form

Dandelion’s study, seven times the size of Novo’s, determined that people in the lower-risk group who took GLP-1 drugs had 15% to 20% lower risk scores for major adverse cardiovascular events after taking the drug for three years. Treating these additional patients could head off 17,300 heart attacks and 16,700 strokes a year, according to study authors.

“With further validation, this AI-driven approach could potentially unlock a new biomarker or surrogate endpoint that measures [major adverse cardiovascular event] risk, enabling shorter and smaller clinical trials by predicting cardiovascular outcomes earlier without waiting for [adverse events] to occur,” they stated.

Speeding research

Real-world data-based AI could validate GLP-1s for broader applications, from neurological and liver diseases to addiction and arthritis. 

Green said Dandelion already has another GLP-1 study in the works, using AI to assess muscle changes on patient abdominal CT scans to determine whether GLP-1 drugs also cause muscle to wither during weight loss. The platform could also help pharma companies explore and validate label expansion opportunities and perform other types of research. Dandelion is working with several companies, Green said.

“Clinical trials are very focused. You come in with a very specific question, and you get a very specific patient population,” Green said, noting that a broader approach is often too challenging due to time and cost constraints. 

With AI, instead of looking at a limited area, similar to what you might see under a single street light, Green said, you can illuminate the whole neighborhood.

Credit: pharmavoice.com

Team Metabolic Health

Small biotechs are making gains with AI drug development, and their advantages may help some push ahead without Big Pharma.

AI is making its mark on the pharma market, presenting opportunities for Big Pharma to cut down on drug development costs and fast-track new discoveries. But AI’s capabilities also open the door for smaller biotechs to remain independent rather than leaning on deep-pocketed, established pharmas, according to a report from S&P Global Ratings.

Big Pharma has been investing in AI and partnering with tech companies in recent years, and the area’s value could jump from $1 billion in 2022 to a projected $22 billion in 2027, according to data from Boston Consulting Group. 

Getty Images

Many of the early investments in the space were focused on leveraging machine learning. For example, Pfizer teamed up with IBM Watson in 2016 to leverage the company’s machine learning system in drug discovery, while Merck & Co. and AstraZeneca partnered with Amazon Web Services in 2017 to develop a cloud-based drug discovery platform. 

But the collaborations between pharmas, tech companies and biotechs have now “given rise to a new breed of AI-driven [biotech] entities,” according to the report.

This new breed has AI at the center of their platforms, but are still partnering with established pharmas to overcome high development costs. Independent AI biotechs will likely seek more partnerships and collaborations as a result, the report predicted, but also have the potential to break out on their own with treatments that could alter the commercial landscape. 

“The relationship between AI biotechs and big pharma won’t necessarily be symbiotic,” the report stated. “The formers’ significant potential for innovation means they could yet emerge as competitors to pharmaceutical incumbents (and Big Pharma’s R&D functions).”

Already, several biotechs have drug assets in the clinic that were discovered through AI — both with and without Big Pharma contributions. 

Lantern Pharma has several drugs in clinical trials that were discovered through its AI platform. Insilico Medicine has 31 programs and out-licensing agreements for a handful of candidates generated by AI.

AI’s big impact

While S&P didn’t expect that AI will cause an influx of blockbuster drugs, the ratings company forecasted AI biotechs to have a “considerable” impact on shortening the drug development process. 

Bottom of Form

Instead of spending four to seven years in the discovery and preclinical stage, AI could shorten the timeline to two to three years, according to the report. Clinical development could be only three to five years long, shaved down from the current range of seven to nine.

The benefits of speed could help independent biotechs overcome the huge cost challenge of developing new drugs. Between 2022 and 2023,  the cost of moving a new drug from discovery to launch averaged $2.3 billion, according to a report from Deloitte.

With an 85% compound annual growth rate projected for the global pharma-AI market,  the technology will continue to expand its role across the industry. Still, investments in the space will take time to be fully realized. Instead, the gains are likely to be “incremental,” with efficiencies being slight, the report predicted.

“Drug discovery, with or without AI, will remain a complex and time-consuming practice characterized by experimentation, false starts and failures,” the report stated. 

If AI platforms are able to help pharma companies pursue treatments for more complex diseases, working in those complicated arenas could also bog down drug development timelines and increase resource demand, S&P noted.

Credit: pharmavoice.com

Team Metabolic Health

Artificial intelligence (AI) has been revolutionizing much of early drug discovery, yet human clinical trials remain a bottleneck. Now some applications of the new technologies are bringing efficiencies to clinical research.

Sophisticated modeling and simulations suggests that AI can play a major role in improving the success rates of novel drugs entering human studies. The pharmaceutical industry has long struggled with efficiency rates. According to the Congressional Budget Office (CBO), only 14% of drugs that enter clinical trials are ultimately approved by the FDA. The development process is complex and can take many years, with many drugs failing at various stages. Estimates are that the cost of developing one drug can be over $2 Billion.

AI helps clinical trials. Credit: GETTY IMAGES

The goal of modeling software in clinical research is to create programs that can simulate expensive clinical trials. Other technical industries use extensive simulations when building highly complex items like semiconductors and fighter jets. But in some ways, biology is actually harder to model due to the higher systemic complexity.

Simulations hold a multitude of promises for drug development. By pre-emptively modeling trials and getting accurate dosing, the probability of success can be improved and predictability increased. Ultimately, the moonshot is using trial simulations to be able to conduct completely safe patientless trials. Although completely virtual trials are still probably more than a decade away, machine learning and AI have advanced sufficiently to begin to manage human biology and data better.

QuantHealth, an AI-focused clinical trial design company based out of Tel Aviv, has announced the completion of more than 100 simulated clinical trials, reporting an 85% accuracy rate. The company has developed a proprietary AI-based Clinical-Simulator system that combines over 1 trillion data points across the clinical and pharmacological domains to optimize clinical development, according to CEO Orr Inbar.

The clinical trial simulation software enables scientists to holistically model a clinical trial with thousands of variations rapidly, allowing drug development experts to evaluate parameters on the basis of endpoint success, commercial viability, and protocol feasibility. The In-Silico platform generates evidence for how therapy will perform across all clinical phases, as soon as its mechanism is known, and preclinical evidence has been established. This synthetic evidence generation engine can be used to support trial planning, as well as indication selection, drug repurposing, and in-licensing asset evaluation.

In order to address the challenge of finding large swaths of data on which to train its models, AI companies have been working with health systems to gather data to train the model and QuantHealth has spent several years acquiring, processing and analyzing data from proprietary sources. QuantHealth has partnered with OMNY which represents data from 50 provider organizations nationally including hospital systems, nonprofits, community practices, pediatric hospitals and national cancer institutes that represent 78 million patients, or a third of Americans. They have licensed over 350 million patients’ data from databases to get a complete picture of each patient and added five more databases in genetics, cell biology, pharmacology, and biological cascades. The company builds a foundation using clinical trial results and FDA data, with elements of real world data (RWD), and clinical knowledge graphs and then incorporates sponsor’s own additional data.

QuantHealth’s AI can predict phase 2 trial outcomes with 88% accuracy (compared to the actual success rate of 28.9%), and phase 3 trial outcomes with 83.2% accuracy (versus the industry average of 57.8%) according to the company’s press releases and interviews. The technology is able to predict clinical trial outcomes with significantly higher accuracy than current success rates. The accuracy would allow users to answer mission-critical questions such as trial go/no-go, cohort optimization, drug repurposing, and more.

QuantHealth performs trial design for pharma companies and fine-tunes results by changing endpoints or population to determine different outcomes. It can be used for portfolio optimization, how well new drugs will perform against competitors when considering acquisitions, and health systems asking what patients will respond to different trials and their outcomes.

CEO Inbar states that QuantHealth works with five of the top ten big pharma companies, with most clients moving from pilots to multiple trials.

AI in drug research. Credit: GETTY Images

Another important area AI enhanced drug development simulations is accurately predicting appropriate dosing. Drugs are first tested in animals to confirm safety. But understanding how to move from animal doses to humans continues to be a difficult.

Certara is using AI to accelerate the drug development process by technology that can seamlessly incorporate simulations with other approaches to help model dosing based on prior non-human studies.

The US Food and Drug Administration (FDA) has had a long standing collaboration with a number of Certara software licenses for reviewing new drug and biologics applications. Additionally the FDA has awarded grants to expand its predictive models for assessing drug virtual bioequivalence (VBE) and to create a formulation toolbox for topically applied drugs. These capabilities will help enable safer, faster and more cost-effective product development of both complex generics and novel drugs.

AI helps Certara to mine millions of documents and unstructured data sources in a systematic and meaningful manner and also couple data that is in the public domain with a pharmaceutical company’s proprietary data to build a unique database. The AI platform mines about six million public sources, including massive regulatory databases and associated filings, memos, and scientific meetings.

Writing in Pharma Focus Europe, Amin Rostami-Hodjegan and Piet van der Graaf describe applications utilized at Certara. AI helps to manage information overload, particularly when the facts are sparse and seemingly unconnected, by going through data and extracting elements that are useful. It also gives Certara confidence in models by gathering indirect evidence that verifies the model-informed decisions. Certara uses AI to build models that are a mathematical representation of drug physiology and build a biological map. The models help address questions such as, “How long will the molecule stay in the body? Will it turn into an undesirable metabolite?”

Simulations are also used to predict clinical endpoints in discovery for novel mechanisms and to identify new biomarkers. The models can capture fundamental biology and then simulate what happens to the biomarkers, cell types, and cytokines when they put a compound into that system. This allows researchers to predict clinical endpoints for novel mechanisms earlier in the development process.

AI is providing growing support for the drug development process. Its applications range from reviewing millions of data points and gleaning relevant information, to helping build biological maps and models of new mechanisms of action and predicting clinical endpoints.

AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical trial outcomes with significantly higher accuracy than current success rates, it has the potential to save the industry billions of dollars and years of time.

Credit: Forbes

Team Metabolic Health

Key Points

• Danish biotech Zealand Pharma is targeting the “next generation” of weight loss drugs as competitors pile into a market dominated by heavyweights Novo Nordisk and Eli Lilly.
• CEO Adam Steensberg heralded early-stage trial results of its GLP-1 treatment in an interview with CNBC, but said it was the company’s separate obesity drug candidate that sets it apart.
• Zealand Pharma is now scouting for a pharma partner to help it target global markets, Steensberg said, even as takeover speculation mounts.

Jaap Arriens | NurPhoto

Danish biotech Zealand Pharma is targeting the “next generation” of weight loss drugs as competitors pile into a market dominated by heavyweights Novo Nordisk and Eli Lilly.

CEO Adam Steensberg told CNBC Thursday that early-stage trials of its experimental obesity injection point to higher-quality weight loss — with reduced muscle loss and fewer side effects — versus traditional GLP-1 treatments. The company is now scouting for a global pharma firm to partner with, he added.

“Our focus is really what’s needed in the 2030s, and it’s really about establishing, you can say, the next-generation molecules that are not based on GLP-1s,” Steensberg said.

Last month, Zealand Pharma announced positive top-line results from a phase 1b trial of its weight loss drug, a GLP-1/GLP-2 receptor dual agonist called Dapiglutide. It puts the company head-to-head with major obesity players Novo Nordisk and Eli Lilly, whose GLP-1s Wegovy and Zepbound, respectively, have exploded in popularity for their weight loss effects.

However, Steensberg said it’s the company’s separate obesity drug candidate, Petrelintide, a long-acting amylin analog, which could set it apart from the competition, offering an alternative for users who cannot tolerate GLP-1s.

“That’s what we call our crown jewel. This is the one where we have the highest expectations,” Steensberg said.

“We have a very strong feeling that this could become a foundational therapy in the future – something that provides the weight loss that patients are looking for but with the potential for a better tolerability profile,” he added.

Amylin analogs are a nascent form of weight loss treatment. They work by mimicking a hormone that is co-secreted with insulin in the pancreas to increase satiety. This differs from GLP-1 agonists, which mimic incretin hormones produced in the gut to suppress appetite and regulate blood sugar.

“It’s two very different human experiences,” Steensberg said, comparing GLP-1s with amylin analogs. “If you work on satiety, it will be a more pleasant experience. So once you get into it, you can stay long-term [on the] treatment.”

Novo Nordisk is also experimenting with its own version of the treatment, combining the GLP-1 component Semaglutide with amylin analog Cagrilintide in a candidate called CagriSema.

In June, Zealand Pharma also announced positive results from a phase 1b trial of Petrelintide, which showed that a course of 16 weekly injections reduced body weight by up to 8.6% on average.

The company said at the time that the findings showed “robust support” for the drug’s potential as an alternative to GLP-1s. Following the biotech firm’s first-half results in August, Steensberg upped the ante, saying amylin analogs have the potential to become “the future backbone therapy for weight management.”

“If we can develop a molecule that is giving patients the weight loss they’re looking for with a very benign tolerability profile, and we can also show risk reduction when it comes to cardiovascular health, I think we have all the reasons to believe it could become a first-line therapy,” Steensberg told CNBC in the interview Thursday.

Seeking a global pharma partner

Zealand Pharma, which was founded almost three decades ago with a focus on peptide-based medicines, has ridden a rising tide over recent months as it has ventured further into obesity treatments. So far this year, its share price is up more than 110%.

Competition in the sector is fierce, however, with Novo Nordisk and Eli Lilly still dominating the market as their so-called miracle drugs become essential to consumers across the globe.

Several drug regulators, including in the U.S. and European Union, have now expanded GLP-1 drug labels for use in treating obesity-related comorbidities and other illnesses. It comes as concerns remain around the drugs’ other possible side effects, such as muscle loss and suicidal thoughts, and U.S. authorities have pushed back against the high costs of the treatments.

Nevertheless, appetite for the treatments continues to balloon, with analysts estimating that the sector could be worth up to $200 billion by 2030.

Emily Field, head of European pharmaceuticals research at Barclays, said the weight loss market was likely to grow more “fragmented” over time as pharmaceutical companies target different segments, noting that treatments to counter muscle loss could be a good way to “differentiate.”

However, she noted that a company of Zealand Pharma’s size and scope would struggle to do so alone.

“It’s not something Zealand could even think about, manufacturing themselves. A lot of people who have owned it still own it, but are wondering if it’s going to get bought or not,” Field said over the phone.

Steensberg on Thursday ruled out growing speculation around a takeover, saying it’s “definitely not part of our plans.” But he noted that even with a significant $1 billion capital raise earlier this year, the company would need a partner.

“We have a clear ambition to continue into the next phase of our life as a partnering company,” Steensberg said. “We have to have a lot to offer and I think it’s a very attractive opportunity to partner with Zealand right now for a large pharma company.”

He added that partnership discussions are underway and likely to continue into the first half of next year.

Petrelintide and Dapiglutide will now progress to phase 2 trials on overweight and obese patients in late 2024 and the first half of 2025, respectively.

Credit: CNBC

Team Metabolic Health

It’s not your imagination: it is harder to gain — or just maintain — muscle after middle age. Aging brings many changes to the body. One such change is muscle loss. Adults who don’t engage in regular strength training can lose 4 to 6 pounds of muscle per decade.

The technical term for age-related muscle loss is sarcopenia, and it affects nearly 50% of adults above the age of 80. While sarcopenia is a natural part of aging, it can impact quality of life by increasing the risk of frailty, disability, loss of independence, and even death.

To combat sarcopenia, you can build muscle through strength training. Building muscle requires protein, so when you’re aiming to increase muscle mass, your body needs more protein. Increasing dietary protein intake can support muscle repair and growth.

Getting more protein from your diet

The amount of protein a person should consume each day depends on factors such as height, weight, age, sex, and activity level. You can use this USDA calculator to find your daily recommended protein intake. For the average adult, the Recommended Dietary Allowance (RDA) of protein is 0.36 grams per pound of body weight. For a person who weighs 165 pounds, for example, that comes to 60 grams of protein per day.

Unfortunately, many older adults aren’t meeting their daily protein needs. A study published in the Journal of Nutrition, Health & Aging that looked at the diets of nearly 12,000 individuals ages 51 and older found that approximately 46% didn’t meet daily protein recommendations. Lower protein intake makes it more challenging to build muscle mass.

While consuming enough protein to support muscle gains is important for overall health, too much protein can also lead to health issues. Consuming very high amounts of protein per day — anything over 0.907 grams per pound; or about 150 grams per day for a 165-pound person — can be harmful. More than that can cause dehydration or aggravate kidney problems for individuals with pre-existing kidney conditions such as chronic kidney disease or a history of kidney stones.

A wide variety of foods, both plant- and meat-based, are high in protein. These include beans, peas, and lentils; nuts and seeds; lean meats; fish; dairy products; and soy products. Incorporating more of these foods into your diet is the easiest way to up your protein intake.

In addition to eating high-protein food sources, when you consume protein is also important. Experts recommend spreading protein consumption throughout the day, with good protein sources at each meal.

Can protein supplements help?

While the best source of protein in your diet is whole foods, some older adults who cannot get adequate protein through food alone may benefit from supplementation. To decide if you should add protein supplements to your diet, consult with your doctor.

Many people find protein supplements such as protein powders an attractive and easy solution to meeting their daily protein needs. Over-the-counter protein powder supplements have become increasingly popular in the United States and are a multibillion-dollar industry.

One reason may be that protein powders are convenient. They can be easily added to oatmeal or smoothies, or simply mixed into a glass of water. They come with convenient scoopers to help you see exactly how much protein you are adding. Always check the label to find the amount of protein per serving, as this varies by brand of supplement.

However, there are some concerns to be aware of when consuming protein supplements. Protein powders are classified as dietary supplements and are not regulated as strictly as food or medicine. In addition, the sugar content of protein powders can be vary depending on the brand; some brands may have as much as 23 grams per scoop. In addition, whey- or casein-based protein powders can cause digestive discomfort in some individuals.

Types of protein powders

There are three main types of protein powders: whey, casein, and plant-based protein powders. Both whey and casein are animal-based protein powders, made from dairy. Plant-based protein powders are usually a combination of protein derived from wheat, pea, hemp, or soy products.

Of the three, research suggests that whey protein is particularly effective for building muscle in older adults, more so than either plant-based proteins or casein.

For individuals who are avoiding dairy, plant-based protein powder options like soy isolate protein can also be beneficial. These generally have a lower amino acid profile and reduced bioavailability compared to animal-based proteins. Bioavailability is the measure of how much and how quickly a substance, such as a nutrient or drug, is absorbed and becomes available for use in the body. Vegan protein powders made from peas or brown rice are also suitable alternatives to dairy-based protein supplements.

The importance of resistance and strength training for preserving muscle mass

While protein is important for building muscle mass, it should be combined with strength training to combat sarcopenia. Research shows that supplementing the diet with protein plus a regimen of heavy resistance exercise leads to the most improvement in muscle mass and strength in healthy older adults. Together, the two approaches can significantly aid muscle growth in older adults.

Credit:  health.harvard.edu

Team Metabolic Health

Fiber and fermented foods aid the gut microbiome, contributing to better health and mood.

An F may mean failure in school, but the letter earns high marks in your diet. The two biggest dietary Fs — fiber and fermented foods — are top priorities to help maintain healthy digestion, and they potentially offer much more. How can you fit these nutrients into meals? Can this help your overall health as well as gut health?

Fiber, fermented foods, and the gut microbiome

The gut microbiome is a composed of bacteria, viruses, fungi, and other microorganisms living in the colon (large intestine). What you eat, the air you breathe, where you live, and many other factors affect the makeup of the gut microbiome. Some experts think of it as a hidden organ because it has a role in many important functions of the body — for example, helping the immune system function optimally, reducing chronic inflammation, keeping intestinal cells healthy, and providing some essential micronutrients that may not be included in a regular diet.

Your gut communicates with your brain through pathways in the gut-brain axis. Changes in the gut microbiome have been linked with mood and mental health disorders, such as depression and anxiety. However, it’s not yet clear that these changes directly cause these types of problems.

Making Sense of Vitamins and Minerals

About half of all Americans routinely take dietary supplements. The most common ones are multivitamin and multimineral supplements. Making Sense of Vitamins and Minerals: Choosing the foods and nutrients you need to stay healthy explains the evidence behind the benefits and safety profiles of various vitamins and minerals. It also includes the recommended minimum and maximum amounts you should consume, as well as good food sources of each.

We do know that a healthy diet low in processed foods is key to a healthy gut microbiome. And increasing evidence suggests that fiber and fermented foods can play important parts here.

Fiber 101

Fiber’s main job is to make digestion smoother by softening and adding bulk to stool, making it pass quickly through the intestines.

But fiber has other benefits for your microbiome and overall health. A high-fiber diet helps keep body weight under control and lowers LDL (bad) cholesterol levels. Research has found that eating enough fiber reduces the risk of heart disease, type 2 diabetes, and some cancers.

What to know about fiber

There are two types of fiber: insoluble (which helps you feel full and encourages regular bowel movements) and soluble (which helps lower cholesterol and blood sugar). However, recent research suggests people should focus on the total amount of fiber in their diet, rather than type of fiber.

If you’re trying to add more foods with fiber to your diet, make sure you ease into new fiber-rich habits and drink plenty of water. Your digestive system must adapt slowly to avoid gas, bloating, diarrhea, and stomach cramps caused by eating too much too soon. Your body will gradually adjust to increasing fiber after a week or so.

How much fiber do you need?

The fiber formula is 14 grams for every 1,000 calories consumed. Your specific calorie intake can vary depending on your activity levels.

“But instead of tracking daily fiber, focus on adding more servings of fiber-rich foods to your diet,” says Eric Rimm, professor of epidemiology and nutrition at Harvard’s T.H. Chan School of Public Health.

Which foods are high in fiber?

Fruits, vegetables, legumes, nuts, seeds, and whole grains are all high in fiber. The Dietary Guidelines for Americans has a comprehensive list of fiber-rich foods and their calorie counts.

What about over-the-counter fiber supplements that come in capsules, powders that you mix with water, and chewable tablets? “If you have trouble eating enough fiber-rich foods, then these occasionally can be used, and there is no evidence they are harmful,” says Rimm. “But they should not serve as your primary source of dietary fiber.”

Fermented foods 101

Fermented foods contain both prebiotics — ingredients that create healthy changes in the microbiome — and beneficial live bacteria called probiotics. Both prebiotics and probiotics help maintain a healthy gut microbiome.

What to know about fermented foods

Besides helping with digestion and absorbing vital nutrients from food, a healthy gut supports your immune system to help fight infections and protect against inflammation. Some research suggests that certain probiotics help relieve symptoms of gut-related conditions like inflammatory bowel disease and irritable bowel syndrome, though not all experts agree with this.

Many foods that are fermented undergo lacto-fermentation, in which natural bacteria feed on the sugar and starch in the food, creating lactic acid. Not only does this process remove simple sugars, it creates various species of good bacteria, such as Lactobacillus or Bifidobacterium. (Keep in mind that some foods undergo steps that remove probiotics and other healthful microbes, as with beer or wine, or make them inactive, like baking and canning.)

The exact amounts and specific strains of bacteria in fermented foods vary depending on how they are made. In addition to probiotics, fermented foods may contain other valuable nutrients like enzymes, B vitamins, and omega-3 fatty acids.

How often should you eat fermented foods?

There is no recommended daily allowance for prebiotics or probiotics, so it is impossible to know precisely which fermented foods or quantities are best. The general guideline is to add more to your daily diet.

Which fermented foods should you choose?

Fermented foods have a range of tastes and textures because of the particular bacteria they produce during fermentation or that are added to foods. Yogurt is one of the most popular fermented foods (look for the words “live and active cultures” on the label). Still, many options are available if you are not a yogurt fan or want to expand your fermented choices. Kimchi, sauerkraut, kombucha, and pickles are a few examples.

As with fiber, probiotics are also marketed as over-the-counter supplements. However, like all dietary supplements, they do not require FDA approval, so there is no guarantee that the types of bacteria listed on a label can provide the promised benefits — or are even in the bottle. “Therefore, it is best to get your probiotics from fermented foods,” says Rimm.

Credit:  health.harvard.edu

Team Metabolic Health

The Tata Group’s foray into healthcare began in 1941 with the establishment of the Tata Memorial Hospital in Mumbai.

• Ratan Tata and his team created a vast network of cancer care centers
• Tata knew that cancer treatment had to reach everyone
• He pushed to include these services in government insurance schemes

There is a reason why the titan Ratan Tata, who led over 30 companies in more than 100 countries, was never featured in the list of “billionaires” of the world or India.

Today, as we remember this “humble” tycoon for his significant contribution to philanthropy — long before India even heard of Bill Gates — his work in the field of cancer research in India is especially laudable.

Long before the world recognised the importance of philanthropy, Ratan Tata was quietly making a difference.

People pay homage to business leader Ratan Tata at NCPA lawns, in Mumbai. (Photo: PTI)

The Tata Group’s foray into healthcare began in 1941 with the establishment of the Tata Memorial Hospital in Mumbai. This was no ordinary hospital; it was a sanctuary of care for all, regardless of their background.

With this commitment, the foundation for a revolution in cancer treatment in India — unheard of at the time — was laid. The management of the hospital was handed over to the Ministry of Health in 1962.

Tata knew that cancer treatment had to reach everyone. The high costs meant many couldn’t afford the care. The Tata Memorial Hospital earned its name for providing free or economically viable treatments.

“Now, several Tata Memorial Centers have come up in Varanasi, Muzaffarpur, Punjab, and Visakhapatnam. The Tata Trust has a great legacy in creating facilities across the country to treat cancer patients. In 1992, bone marrow transplants were started by them in India. Nearly 1,000 cancer patients are seen there every day, and almost two-thirds are treated free of cost. This is a huge contribution by the Tata Trust and Tata family, which Ratan Tata continued to support, focusing on cancer care in the country. Their philanthropic contribution must be acknowledged,” said Dr. Shyam Aggarwal, head of medical oncology at Sir Ganga Ram Hospital, Delhi.

Tata Group Chairman Emeritus Ratan Tata speaks during an event, in Mumbai. (Photo: PTI)

In 2012, the Trusts launched the Tata Medical Center in Kolkata to address the high prevalence of cancer and the lack of suitable facilities in the eastern and northeastern regions.

The Tata Trusts are expanding their network to 20 hospitals across seven states: Andhra Pradesh, Assam, Jharkhand, Maharashtra, Uttar Pradesh, Odisha, and Gujarat.

Fast forward to 2017, when Ratan’s passion and dedication led to the launch of the ambitious Cancer Care Program through the Tata Trusts. This program introduced a groundbreaking concept: the “Distributed Cancer Care Model.” Imagine a world where cancer care is accessible, affordable, and of high quality—this was Ratan’s dream.

Ratan Tata knew his dream had to extend beyond Mumbai. Part of this project included the establishment of new cancer hospitals in Assam and Uttar Pradesh. State governments were also further assisted by Ratan Tata in setting up cancer hospitals and treatment facilities in smaller towns and cities.

Puri: Sand artist Sudarsan Pattnaik creates a sand sculpture to pay tribute to Ratan Tata at Puri beach in Odisha, Thursday, Oct. 10, 2024. (PTI Photo)

Ratan Tata was acutely aware of the statistics: over 70% of cancer cases in India were diagnosed at late stages. With this knowledge, he set an ambitious goal—to reverse that ratio from 30:70 to 70:30.

To bring this dream to life, Ratan and his team created a vast network of cancer care centers, daycare facilities, and screening kiosks. Knowing that financial barriers often kept people from seeking treatment, he pushed to include these services in government insurance schemes, transforming the landscape of cancer care in India.

Recently, the Tata Institute in Mumbai claimed to have discovered a treatment that can prevent cancer from recurring with a tablet costing just ₹100.

Researchers and doctors at the institute worked for 10 years and have now developed a tablet they claim can prevent the recurrence of cancer and reduce the side effects of treatments like radiation and chemotherapy by almost 50%.

Assam Chief Minister Himanta Biswa Sarma mourned Ratan Tata’s passing, highlighting his transformative impact on the state through initiatives in cancer care and the establishment of a semiconductor industry.

Tata’s commitment to Assam was demonstrated through several key initiatives, including the establishment of the Assam Cancer Care Foundation, which aims to enhance healthcare services in the state.

According to the latest IIFL Wealth Hurun India Rich List of 2022, Ratan Tata ranked 421st, with a net worth of approximately Rs 3,800 crore. However, the Tata Group companies have bequeathed their assets to the Tata Trusts, which hold a two-thirds stake in Tata Sons.

Approximately 60% of the dividends from Tata Sons are allocated to charitable endeavors, according to available information.

Tata’s commitment to Assam was demonstrated through several key initiatives. (Photo: India Today)

“As we remember Ratan Tata, his work in revolutionizing cancer care stands as a testament to his vision, compassion, and commitment to improving the lives of millions,” said Dr. Mohit Saxena, Consultant and HOD Medical Oncology at Manipal Hospital, Gurugram.

He added, “Under Tata’s leadership, the Trusts launched impactful awareness campaigns like ‘Kaise Ka Cancer’ and ‘Gaanth Pe Dhyaan.’ The program’s comprehensive approach included community-based cancer screening, training healthcare providers, tobacco control initiatives, and leveraging technology for better patient management.”

As we reflect on Ratan Tata’s remarkable journey, we see a life dedicated to compassion and change. Without the Tata legacy, the advancement of cancer treatment for Indians, by Indians, would perhaps be a distant and very expensive dream.

Credit: India Today

Team Metabolic Health

Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) are entero-pancreatic hormone-based treatments first approved in 2005 for type 2 diabetes (T2D). They are now commonly prescribed for weight loss and reduction of atherosclerotic cardiovascular (CV) risk in patients with T2D. 

The health benefits and market success of GLP-1 drugs are a hot topic in today’s pharmaceutical landscape. According to a MarketWatch report from February 2024, the global GLP-1 market is expected to reach $471 billion by 2032. As of February 2024, there were 15 GLP-1 medications approved by the FDA for glycemic and weight control, and more were already in development.

imyskin via Getty Images

More than one billion people worldwide are living with obesity, which puts them at risk of major health complications, such as T2D, high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver diseases, some cancers, kidney disease, breathing problems, and sleep apnea. Most of these diseases are interrelated, with glycemic control and weight loss being a major factor in improving the overall health of sufferers.

We are in an era where combinations of entero-pancreatic hormones can deliver significant weight loss, and patients are experiencing health benefits well beyond blood sugar management and weight loss.

“As we learn more about GLP-1 RAs, we realize that they target many organ systems, including the pancreas, the stomach, brain, heart, kidneys, immune system (due to reduced inflammation), skeletal muscle, control of metabolism of both white and brown adipose tissue, and positive effect in fatty liver disease (nonalcoholic fatty liver disease and steatohepatitis; MAFLD and MASH),” says Dr. Gaetano Morelli, Chief Medical Officer at Altasciences.

What GLP-1 is and how receptor agonists work

Dr. Gaetano Morelli explains, “GLP-1 is a hormone called an incretin or gut peptide released by endocrine cells in the small intestine in response to nutrient ingestion, mainly glucose and fat.”

Clinical data on GLP-1 RAs

GLP-1 RAs mimic the action of endogenous GLP-1 and, in head-to-head clinical studies, have demonstrated that all GLP-1 RAs are effective at reducing A1C levels. These initial pivotal studies that led to the first wave of GLP-1 RAs demonstrated that they work in several ways, including stimulating insulin release, slowing digestion, reducing appetite, and inhibiting glucagon release.

A guidance from the U.S. FDA (draft updated in March 2020) requires data on cardiovascular events in new T2D drug development programs. As a result, dedicated cardiovascular safety trials were implemented. Many demonstrated beneficial effects of GLP-1 RAs on the heart and kidneys in patients with T2D (with and without preexisting conditions), with those effects thought to be largely independent of glucose-lowering. 

More recently, pharmaceutical companies have sponsored large cardiovascular outcomes trials (CVOTs) to assess the beneficial effects of GLP-1 RAs on the cardiovascular system in patients with T2D, with encouraging results. 

What comes next

Looking to the next generation of clinical trials for obesity treatments, we see combinations of GLP-1 RAs with other entero-pancreatic hormones with complementary actions and/or synergistic potential (such as glucose-dependent insulinotropic polypeptide (GIP), glucagon, and amylin) to enhance the weight loss and cardiometabolic benefits of GLP-1 RAs. There are currently more than 140 of such compounds in development. Drug developers are also investigating the potential for longer-lasting injections.

Oral formulations are another future enhancement for GLP-1 RA medicines, with several pill forms in development. Various physiological barriers, such as mucus, intestinal, and enzymatic barriers, interfere with the oral delivery or absorption of protein and peptide-based therapeutics. Thus, novel approaches such as nanocarriers, site-specific, and stimuli-specific delivery, are being used to improve the success of oral GLP-1 RAs.

Sources indicate that newer GLP-1s have fewer side effects, although the most common gastrointestinal issues (nausea, vomiting, and diarrhea) may continue. Loss of muscle mass, often associated with rapid weight loss, is another potential side effect being investigated. Long-term side effects of GLP-1 usage are currently unknown, and researchers are accumulating data as this therapeutic area continues to boom.

“Promising programs have been halted due to challenges with side effect profiles and drug interactions, and diligent, expert program development will be critical as we move into the next generations of these important therapeutics,” says Dr. Morelli. “Developing newer and better GLP-1 RAs is a crucial contribution to global human health, and it is a field we at Altasciences are proud to be advancing.”

Credit: biopharmadive.com

Maybe — but that could be the wrong question.

Team Metabolic Health

What we eat can play a pivotal role in warding off — or treating — disease and enhancing quality of life. You may already believe this, and certainly mounting evidence supports that idea. But on the cluttered shelf of diets claiming top health benefits, which one ranks as the absolute best?

That’s a trick question. In fact, there is no single best diet. A good diet for me may be different from what’s best for you. And for either of us, there may be several good choices with no clear winner.

How can you choose the right diet for you?

When thinking about what diet might be best for you, ask yourself:

What goals are most important? A goal might be weight loss, improved health, avoiding disease, or something else.

How do you define “best”? For some people, best means the diet with the highest number of health benefits. For others, it may focus on one specific health benefit, such as lowering cholesterol. Still other people may prefer a diet that delivers the greatest benefit for the lowest cost. Or a diet that is healthy and also easy to stick with.

What health problems do you have? One diet may have an advantage over another depending on whether you have cancer, cardiovascular disease, diabetes, or none of these.

Which foods do you like best? Your tastes, culture, and location may shape your dietary preferences, and powerfully affect how likely you are to stick with a specific diet.

Which diets are high in health benefits?

Two very well studied diets demonstrate clear benefit, including lowering risk for heart disease and stroke and reducing high blood pressure: the Mediterranean diet and the DASH diet.

But the portfolio diet may be as good as or better than these plans, at least for combatting cardiovascular disease that contributes to clogged blood vessels, heart attacks, and stroke. What? You’ve never heard of the portfolio diet? You’re not alone.

What is the portfolio diet?

Just as a financial advisor may recommend having a diverse investment portfolio — not just stocks, not just bonds — the portfolio diet follows suit. This largely plant-based diet focuses on diverse foods and food groups proven to lower harmful blood lipids, including LDL (so-called bad cholesterol) and triglycerides.

If you choose to follow this eating pattern, you simply need to learn which foods have a healthy effect on blood lipids and choose them in place of other foods. For some people, this only requires small tweaks to embrace certain foods while downplaying other choices. Or it may call for a bigger upheaval of longtime eating patterns.

Which foods are encouraged in the portfolio diet?

Below are the basics. Eating more of these foods regularly may help lower levels of harmful blood lipids:

Credit: health.harvard.edu

Team Metabolic Health

Essential Guide to GLP-1 Agonists for Weight Loss: It was originally thought that GLP-1 agonists could help people with type 2 diabetes, but now they are known to help people lose weight very effectively. These medicines work like the hormone glucagon-like peptide-1, which helps keep blood sugar and hunger levels in check.

GLP-1 agonists can help people lose a lot of weight, even if they don’t have diabetes, by making them feel full and lowering the amount of food they eat. Options like semaglutide and liraglutide have shown promise in clinical studies.

Anyone thinking about using them to lose weight needs to know about their benefits, possible side effects, and the right way to use them.

What Are GLP-1 Agonists?

GLP-1 agonists, also known as glucagon-like peptide-1 receptor agonists, are a group of drugs that were first created to treat type 2 diabetes. These drugs work like the hormone GLP-1, which is found in the body and is very important for controlling blood sugar and hunger.

GLP-1 agonists help lower blood sugar levels by making insulin work better and stopping glucagon from working. They also slow down the emptying of the stomach, which can help you feel fuller and eat less, which is especially good for weight loss.

There are a number of GLP-1 agonists on the market right now, such as semaglutide (marketed as Ozempic and Wegovy), liraglutide (Saxenda), and dulaglutide (Trulicity). Although these medicines have mostly been used to treat diabetes, studies have shown that they can also help people who don’t have diabetes lose a lot of weight.

In fact, new study shows that they can help people lose weight, which makes them an important tool in the fight against obesity.GLP-1 agonists are especially good for helping you lose weight.

People who take these drugs can lose 10 to 15 percent of their body weight in a year, and some people lose even more. People who lose weight often also see changes in their metabolic health, such as lower blood sugar, better cholesterol levels, and lower blood pressure.

GLP-1 agonists are a good choice for people who are overweight or obese and are having health problems because they help you lose weight in a healthy way.

Benefits and Considerations

One great thing about GLP-1 agonists is that they can make you feel less hungry and cut down on your wants. By affecting the brain’s hunger control areas, these drugs can help people feel fuller for longer, which can make it easier to stick to a low-calorie diet.

This can be especially helpful for people who have a hard time controlling how much they eat. GLP-1 agonists also help you lose weight slowly, which helps you keep your lean muscle mass, which is important for keeping your metabolism healthy.

But even though GLP-1 agonists have a lot of benefits, they can also have some bad affects. Some of the most common side effects are feeling sick, throwing up, having diarrhea, and stomach pain, especially when you first start taking the medicine. Most of the time, these signs get better as the body gets used to them.

People who are thinking about taking GLP-1 agonists should talk to a doctor or nurse about the possible side effects and find out if these drugs are right for them. Also, GLP-1 agonists are usually recommended as part of a complete weight loss plan that includes changes to your diet and more exercise.

Another thing to think about is how much GLP-1 agonists cost and how easy it is to get them. These medicines can be pricey, and insurance plans may not cover them all. People should check with their insurance company and look into patient aid programs if the cost is a problem.

In addition, GLP-1 agonists are given through injection, which some people may not like. Those who are thinking about getting regular injections need to know how much time and effort they will take.

To sum up, GLP-1 agonists look like a good way to lose weight, especially for people who are overweight. They are useful for managing weight because they make you feel fuller, help you lose weight in a healthy way, and improve the health of your metabolism.

But people who are thinking about using these medicines should compare the benefits to the risks and costs. Talking to a doctor or nurse is important to make sure that your weight loss plan is safe, successful, and fits your health needs and goals.

As long as obesity is a major health problem around the world, GLP-1 agonists will likely play a bigger part in treatment plans. More study is needed to find out what their long-term effects are and if they can be used for things other than weight loss and diabetes management.

People who want to lose weight and keep it off may find that GLP-1 agonists are a useful addition to their toolbox. They may give them hope for long-term weight loss and better health generally.

Credit: ahrcc.in

Team Metabolic Health

The number of adults in England to have started vaping despite never having been regular smokers has reached one million, scientists estimate.

This is a sharp increase on 2020, with disposable vapes having been available since 2021.

The rise is driven mostly by young adults – with about one out of every seven 18-24-year-olds who never regularly smoked now using e-cigarettes.

While some may have benefited by taking up vapes instead of traditional cigarettes – the trend could be worrying, experts say.

Many people who take up vaping have never been regular smokers. (Getty Images)

‘Less harmful’

Lead researcher, Dr Sarah Jackson, at University College London (UCL), said the public-health impact of the “substantial rise” in vaping among people who have never regularly smoked depended on what they would otherwise be doing.

“It is likely that some would have smoked if vaping were not an available option,” she said.

“In this case, vaping is clearly less harmful.

“However, for those who would not have gone on to smoke, vaping regularly over a sustained period poses more risk than not vaping.”

How dangerous is vaping?

Researchers looked at surveys of about 150,000 adults in England between 2016 and 2024.

Respondents agreeing with the statement: “I have never been a smoker – ie smoked for a year or more,” were counted as “never regular smokers”.

And between 2016 and 2020, only 0.5% of these vaped.

But by April 2024, this had risen to 3.5%, with more than half aged between 18 and 24.

Over the last few years, these “never regular smokers” who took up vapes tended to be younger, more were women, and more were drinking at increasing levels, than in the past, researchers say.

The study, published in the journal Lancet Public Health journal and funded by charity Cancer Research UK, also found overall vaping figures among adults were levelling off.

Disposable vapes to be banned for child health

Senior researcher, Prof Jamie Brown, at UCL, said: “These findings are a reminder that action is required to try to minimise vaping among young people who have never previously smoked.

“However, a balancing act is required to avoid deterring smokers from using e-cigarettes to quit.”

Current government plans to ban disposable vapes were unlikely to be the solution, Prof Brown suggested, as popular brands had already launched reusable products that looked and costed almost the same.

“A sensible next step would be to introduce stricter regulation around product appearance, packaging and marketing,” he added

Steep fall in young smokers in past decade

Hazel Cheeseman, chief executive of campaign group Action on Smoking and Health (Ash) said the findings could be a cause for concern and suggested focusing on reducing the appeal of vapes would be the best way to limit the use of vapes in non-smokers.

“The aggressive marketing of products to young people means the government urgently needs to bring back the Tobacco and Vapes Bill, to regulate vape flavours, marketing and branding,” she said.

Peter Hajek, professor of clinical psychology, at Queen Mary University of London, said: “The just-released figures from the Office for National Statistics show that UK smoking prevalence is under 12%, an all-time low.

“If much less risky alternatives are allowed to continue to compete with cigarettes, smoking – and heart disease, lung disease and cancers that it causes – will continue to decline as well.

“The UK and USA, which allow vaping, have seen significantly faster declines in cigarette sales and in smoking among young and low-income people than Australia, which bans vaping. “

Credit: BBC News

Team Metabolic Health

England’s National Health Services will offer Eli Lilly’s (LLY.N), opens new tab weight-loss drug to nearly a quarter million people as part of a three-year plan, the country’s drugs cost regulator said on Thursday.

The drug, called Mounjaro in the UK and Zepbound in the U.S., would be initially offered to obese people with at least three weight-related health conditions, the National Institute for Health and Care Excellence said.

The conditions are hypertension, sleep apnea, cardiovascular disorders and unhealthy levels of lipids like cholesterol.

As part of a phased rollout, the drug would then be offered to people with two of the conditions and then to those with just one.

The plans have been described in an application from the NHS to UK’s National Institute for Health and Care Excellence.

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. REUTERS/Brendan McDermid

As part of the plan, the NHS will test several new services to offer the drug, including digital technologies, and will select the most cost-effective one.

NHS plans to offer the drug as part of a “wraparound package”, which will include diet and exercise support through primary or secondary care clinics.

“This is no small task for the NHS, and it will be difficult to provide the level of wraparound care seen in patients who took part in the clinical trial,” said Simon Cork, a physiology lecturer at Anglia Ruskin University.

About 64% of adults are either overweight or living with obesity in England, according to a national survey.

Rival Novo Nordisk’s (NOVOb.CO), opens new tab Wegovy made its weight-loss debut in the UK last year and was also approved in July to reduce risk of serious heart problems or strokes in overweight and obese adults.

The NHS currently offers Wegovy through specialist weight management services.

Credit: Reuters

Team Metabolic Health

Doctors can provide alternative forms of screening for colon and rectal cancer but sometimes have a good reason to stick with the colonoscope.

This year about 53,000 Americans are expected to die from colon or rectal cancer. Doctors say most people should start getting screened at age 45. Yet many who are eligible skip testing.

When most people in this country think of colon cancer screening, they think of colonoscopies, which let doctors examine the colon but can be inconvenient. Yet there are other equally acceptable options for screening.

If more people knew about other kinds of colorectal cancer testing, some experts hope, perhaps some who put off colonoscopies would be screened and deaths from colon cancer could be avoided.

A colonoscopy will find 95 percent of the time if cancer is present, but other tests that rely on fecal samples are not always as accurate .Credit: iStock/Getty Images Plus

Here’s what you need to know about colonoscopies and fecal tests, which to ask for, and why your doctor might be recommending one over the other.

How do colonoscopies and fecal tests work?

Colonoscopies are widely used, but there is another option available: fecal tests.

Both types of test attempt to find cancers and large polyps — growths on the wall of the colon — that occasionally turn into cancers. Cancers that are found early often can be cured when doctors simply cut them out. Finding and removing polyps can also prevent cancers.

Colonoscopies start with a patient’s taking strong laxatives to empty the colon. On the day of the test, the patient is sedated. Then, a doctor inserts a colonoscope — a flexible tube with a video camera at the end — into the rectum and colon and looks for polyps and cancers to remove. The doctor may also take samples for study in a lab.

If no polyps or cancers are found, the average patient can wait 10 years before having another colonoscopy.

Fecal tests can be done at home. Patients collect a stool sample and mail it to or drop it off at a testing lab.

One option is the fecal immunochemical test, or FIT, which should be repeated annually. A lab analyzes the sample for traces of blood, which can indicate a polyp or cancer. Large polyps and colon cancers sporadically ooze small amounts of blood. If blood is detected, the patient must have a colonoscopy.

Another more complex fecal test is Cologuard, repeated every three years. It looks for blood in stool and also for abnormal DNA from large polyps and colon cancers. Like the FIT test, Cologuard must be followed by a colonoscopy if blood or abnormal DNA are present.

Which option actually works better?

That depends on what is meant by “better.”

One measure is how often a test finds large polyps.

If a person who has a large polyp has a colonoscopy, the test will detect it 95 percent of the time. If that person has a Cologuard test, there is a 42 percent chance that it will be positive because of the polyp. If the person has a FIT test, there is about a 22 percent chance it will be positive.

Another measure is how likely the test is to find cancers when they are present.

Colonoscopies find 95 percent. A one-time Cologuard test will be positive 94 percent of the time if a cancer is present, and a FIT test will be positive 74 percent of the time.

The ultimate goal, though, is preventing colon cancer deaths. For now, no one really knows which test performs better. One large clinical trial by the Department of Veterans Affairs is comparing the number of colon cancer deaths among 50,000 patients randomly assigned to have a colonoscopy or an annual FIT test and followed for 10 years.

Results are expected in 2027 or 2028.

While those studies are continuing, other studies have compared a screening test with no test.

One study found that after 30 years, people who had fecal tests had a 33 percent lower death rate from colon cancer than people who were not screened. The death rate fell to 2 percent, from 3 percent.

A 10-year European study of colonoscopy found a 30 percent reduction in the risk of getting colon cancer. It was 0.84 percent in a group that had colonoscopies and 1.22 percent in a group that was not screened. There was no difference in the risk of dying from colon cancer.

Whether the reduction in the risk of getting colon cancer is worth a potential risk of injury during the surgery is “in the eye of the beholder,” said Dr. Michael Bretthauer, a gastroenterologist at the University of Oslo who led the study.

Can I ask my doctor for a fecal test if I prefer it to a colonoscopy?

Of course — if you are of average risk, meaning no family history of colon cancer and no genetic condition that predisposes to colon cancer. If you are at a higher risk, your doctor is likely to advise a colonoscopy.

When patients of average risk ask Dr. David Lieberman, a gastroenterologist at Oregon Health and Science University, if they can skip the colonoscopy, he explains that a fecal test and a colonoscopy accomplish different things. Fecal tests are likely to find cancers when they are early enough to be cured. But he says those tests are not so good at finding precancerous polyps. While the hope is that, repeated over time, the fecal tests will find polyps, colonoscopies find both with a single test.

Hearing that, he said, most patients decide they want colonoscopies.

Credit: The New York Times

Team Metabolic Health

It has been labelled a “miracle drug” and has become a trending hashtag on social media, with celebrities like Sharon Osbourne, Rebel Wilson and US comedian Tracy Morgan touting its weight-loss benefits.

Yet more than six years after Ozempic first came onto the global market, Kiwis are still not able to get their hands on a drug many claim is the answer to shedding stubborn kilos for those who have tried nearly every other weight-loss strategy.

Peter Shepherd, a molecular medicine professor at Auckland University and expert in diabetes and obesity, says the long-term impact of Ozempic “could be huge” for New Zealanders.

“We can argue till the cows come home about whether people should lose weight themselves the so-called ‘hard way’, but the reality is, for many, it is just not happening. So either we sit here and ignore [the obesity problem], or we do something about it.”

Ozempic mimics a hormone called GLP-1, which helps lower blood sugar and promotes a feeling of fullness, making it easier for users to cut out snacking.

Shepherd is supportive of the drug being funded in New Zealand as he believes the greater health benefits of a decline in obesity – like a decrease in cardiovascular disease, less kidney dialysis and even improved mental health – would be a worthy return on investment.

The injectable drug Ozempic has been approved for the treatment of type-2 diabetes in New Zealand, but it is not sold here currently. (File photo) ASSOCIATED PRESS

‘Life-changing’ for one Kiwi

Since Ozempic is not sold in New Zealand, only a handful of Kiwis have been able to use the drug.

One of them is Wellington company director Finlay Thompson. For him, it was “life-changing”.

He enrolled in an international clinical trial in April last year, which aimed to research the effects of taking Ozempic along with another non-weight loss drug.

Weighing 138kg, Thompson says he struggled with his weight for years and unsuccessfully tried every kind of diet and exercise programme under the sun to shift it. When he got the chance to take Ozempic, he jumped at it.

And the weight started falling off.

“It is hard to explain, but it changed the way I felt about food. Before the trial, I was basically thinking about food the whole time, but when I was on Ozempic, I no longer felt like that. It all went away.

“Suddenly when I went to functions or dinners, I ate and became quite full, where before I could eat and eat and never really feel full. It was quite odd.”

Thompson lost 30kg before his weight plateaued at 108kg. He says the trial required him to stop taking Ozempic about a month ago, with researchers now studying the effects after patients stop taking the drug. So far he hasn’t regained any of the weight he lost.

He experienced some side effects while taking the drug, “mostly gut-related”, but says these were nothing compared to the health impacts of being overweight.

Thompson says while he would still like to lose another 8kg or 9kg, the 30kg loss is “enough” to have changed his life.

“At 138kg, that’s quite a debilitating state to be in. Everything is just easier now, even just walking around. Imagine walking around with a heavy 30kg bag and then just putting it down. It makes a massive difference.”

The drug comes with the risk of side effects like nausea, diarrhoea and constipation, but serious side effects are rare, Shepherd says.

“It’s not the final solution. There will be learnings as we go on that will lead us to, say, identify the people for whom this is the right drug or limit the side effects. It is very exciting, but we will learn along the way.”

Diabetes drug used for weight loss

Ozempic, the trade name for a semaglutide injection, was developed to treat type 2-diabetes. Semaglutide works by mimicking a hormone called GLP-1, which helps lower blood sugar and promotes a feeling of fullness.

Ozempic is changing eating habits, and food companies are taking notice

“GLP-1 was found to improve the way we produce insulin, and so the idea was to develop this as an anti-diabetic drug to improve the body’s ability to release the right amount of insulin,” Shepherd says.

“Then it was realised that when you had higher doses of this GLP-1, people started to lose a bit of weight. And so what they did was develop chemical ways to make the drug last longer in your blood.

“So what Ozempic is is basically a modified human hormone that helps treat diabetes and also has weight-loss effects.”

Ozempic is made by Danish pharmaceutical company Novo Nordisk, the same company behind popular weight-loss drug Wegovy, which is also a semaglutide injection.

Its direct competitor is American pharmaceutical company Eli Lilly, which sells a similar drug under the brand names Mounjaro, for diabetes, and Zepbound, for weight loss.

Shepherd explains Ozempic is not the same as Saxenda, an anti-diabetic prescription medication currently available and used for weight loss in New Zealand. Saxenda is not funded.

Saxenda is a form of liraglutide rather than semaglutide, and Shepherd says although it is similar, “semaglutide hangs around longer and so it is more effective”.

Ozempic does not work for everyone and some find the side effects unbearable.

Medsafe announced in June last year it has approved Ozempic for the treatment of type 2 diabetes. Despite the regulatory approval, Novo Nordisk has still not launched the product here.

Professor Peter Shepherd, a molecular medicine professor at Auckland University and expert in diabetes and obesity, is supportive of Ozempic being funded as the greater health benefits of a decline in obesity would be a worthy return on investment.

A spokesperson for the company says it is “exploring options to provide access to Ozempic for people living with type-2 diabetes in New Zealand”, but did not respond to a question about when the drug will be available.

Information on the company website states that “increased demand for Ozempic”, coupled with “capacity constraints at some of the manufacturing sites”, have led to shortages of the drug, which are expected to continue throughout 2024.

“It is uncertain when supplies will be sufficient to fully meet current demand.”

The price tag

While there is no way to know what the sale price will be when Ozempic is finally launched in New Zealand, it could be similar to that in Australia, where a month-long supply costs about A$140 (about $150) if not funded via Australia’s Pharmaceutical Benefits Schedule.

This is significantly cheaper than in the US, where Ozempic retails for an average of US$936 a month – about $1480.

Saxenda currently sells in New Zealand for about $480 for a month’s supply.

Associate Professor Hesham Al-Sallami, a University of Otago expert on diabetes and obesity medication, believes if Ozempic or similar medicines were funded in New Zealand, it would take considerable pressure off the hospital system.

“If Ozempic can help patients lose weight, this could reduce the number of people getting type-2 diabetes in the first place,” Al-Sallami said in an article published on the university website last year.

“If this drug is made accessible in New Zealand as a weight-loss medication and is funded by Pharmac for that use as well, this could have considerably positive health outcomes for the country, taking pressure off the hospital system by reducing things like heart attacks and strokes.”

A Ministry of Health spokesperson says while Ozempic has not been approved as a treatment specifically for weight-loss in New Zealand (Novo Nordisk has not applied for this approval), Ozempic may still be prescribed by a medical practitioner for treating obesity.

“In these cases, the prescriber has the responsibility to ensure all treatment meets ethical and professional standards.

“If the use of a medicine is unapproved, the consumer should be advised, and the prescriber should discuss the evidence to support the use and any potential associated safety concerns.”

It is unclear whether any New Zealanders are importing Ozempic from overseas for personal use.

While it is legally possible to do so, the process is cumbersome and might prove difficult given there is a global shortage of Ozempic.

In August, the Australian Therapeutic Goods Administration reviewed the shortage of the drug and advised clinicians not to start new patients on Ozempic unless absolutely needed, and consider changing patients already on Ozempic to an alternative “as continuous supply cannot be guaranteed”.

The UK Department of Health and Social Care has banned the export of all forms of semaglutide and, according to media reports, many other European countries are considering imposing the same ban.

Another complication in importing Ozempic is the fact that it should be kept refrigerated at 2C to 8C.

A Medsafe spokesperson says Kiwis are allowed to import Ozempic from overseas if they have the authority from a New Zealand-registered authorised prescriber (usually their GP).

“Medsafe continues to warn that ordering medicines over the internet can be a risky business as a site may be located overseas and not have the credentials it claims to have,” the spokesperson says.

“In particular, ordering medicines is fraught with problems exposing the purchaser to poor quality and possibly counterfeit products from potentially illegal sources.”

Credit: thepress.co.nz

Team Metabolic Health

The U.S. Food and Drug Administration removed Eli Lilly’s (LLY.N), opens new tab blockbuster weight-loss and diabetes drugs from its shortage list late on Wednesday, likely piling pressure on firms selling cheaper versions known as compounded drugs.

Diabetes treatment Mounjaro has been on the health regulator’s shortage list since late 2022, while weight-loss drug Zepbound was added in April as demand far outstripped supply.

The limited supply for Lilly’s drugs, as well as rivals from Novo Nordisk (NOVOb.CO), opens new tab, had led to a boom in demand for compounded medicines, or custom-made treatments created by combining, mixing, or altering drug ingredients.

Federal regulations allow compounded versions to be sold to meet demand if a drug is in shortage. Outside of a shortage, compounders cannot make the drugs “regularly or in inordinate amounts.”

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. REUTERS/Brendan McDermid/File

“This essentially precludes compounded tirzepatide from being produced commercially,” BMO Capital Markets analyst Evan Seigerman said in a research note, referring to the chemical name for Lilly’s drugs.

Novo Nordisk’s treatments still appeared on the FDA’s shortage list on Thursday. Lilly has started selling vials of the lowest dose of Zepbound in U.S. through its direct-to-consumer website to improve availability and combat the rise in popularity of compounded versions.

BMO’s Seigerman had earlier said that if the additional supply in vials gets Lilly’s drugs removed from the shortage list, it would allow the drugmaker to more easily sue those selling compounded versions of Zepbound.

Shares of Hims & Hers Health (HIMS.N), opens new tab, which offers compounded versions of Novo’s treatments, fell 7% to $17.62 in premarket trading.

Lilly is investing billions of dollars to boost production amid surging demand for Mounjaro and Zepbound. Novo, which makes rival drugs Ozempic and Wegovy, is also ramping up supply to meet unprecedented demand.

Credit: Reuters