Tag: chronic diseases

March 18, 2023

Ozempic prescriptions can be easy to get online. Its popularity for weight loss is hurting those who need it most | CNN

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CNN
— 

Telehealth and social media are playing a significant role in driving demand for Ozempic, a prescription drug that treats Type 2 diabetes, experts told CNN. The current drug shortage has limited access for patients with diabetes who rely on it to control their blood sugar.

Digital health companies make medications like Ozempic easier to get by providing prescriptions online. Many advertise quick and easy — sometimes same-day — access.

“Anecdotally, it’s almost easier to get medication [via digital health companies],” said Dr. Disha Narang, endocrinologist and director of obesity medicine at Northwestern Medicine, Lake Forest Hospital. “But not always the safest.” People who put in average weights on the online intake forms were still offered the antidiabetic drug, Narang told CNN.

In part because of Ozempic’s popularity, the prescription weight loss drug market has grown significantly, according to MarketData Enterprises, an independent market research and consulting firm. The market surpassed forecasters’ expectations for 2022 and is expected to become a nearly $2 billion industry in 2023.

WeightWatchers is also tapping into the telehealth prescription drug space. Last week, the company bought telehealth subscription service Sequence, which helps connect patients to doctors who can prescribe weight loss and diabetes drugs.

“At the start of 2022, these companies weren’t marketing this stuff,” Narang said, noting advertising around Ozempic took off in 2022. “I think we really need to start questioning our ethics around this.”

There are few across-the-board requirements when it comes to digital health companies’ intake processes, Dr. Bree Holtz, an associate professor at Michigan State University studying telemedicine, told CNN. Once a patient fills out the required forms online, information gets transferred to an in-state provider who can write the prescription. Some companies require that the patient hop on a video or phone call with the provider — others don’t require either.

“It’s a little scary that you can just wake up and get these appointments in — or these pharmaceuticals — and you’re not being cared for,” said Holtz.

Telehealth has been a game changer in providing access to health care, particularly during the pandemic. And especially for people living in places where high-quality primary care is not available, direct to consumer telehealth services can help fill a gap, said Dr. Laurie Buis, associate professor in the Department of Family Medicine at the University of Michigan, whose research focuses on digital health.

When patients begin to seek selective treatment from selective providers, however, Buis says it opens the door to problems like fragmented care or abuse. Telehealth providers may not have access to a patient’s full medical history and may be less able to provide holistic care that a primary care physician otherwise could.

“I have no doubt that some of these services are doing a good job,” said Buis. “There are also services that don’t take it quite as seriously. And that’s of concern.”

The US Food and Drug Administration first announced that Ozempic was in shortage last August. Supply will likely be strained through mid-March, according to the FDA drug shortages database.

Ozempic prescriptions in the US reached an all-time high in the last week of February, with over 373,000 prescriptions filled, according to a J.P. Morgan analysis of IQVIA data shared with CNN. That’s an increase of 111%, compared with the same week in 2022.

Of these, more than half were new prescriptions, according to a CNN review of J.P. Morgan’s analysis.​​

With many patients relying on Ozempic for diabetes treatment, providers like Narang are scrambling to figure out what alternatives to put their patients on.

“We’re getting messages daily about patients not being able to get their own medication,” Narang said. “It’s been tough for patients and providers alike.”

Ozempic currently holds more than 40% of the US market share of glucagon-like peptide 1 (GLP-1) agonists — a class of drugs that mimic an appetite-regulating hormone — according to analysis from J.P. Morgan. These drugs work by stimulating the release of insulin, which helps lower blood sugar. They also slow the passage of food through the gut.

Ozempic has grown quickly in popularity since it was first put on the market in 2018. The drug has safely and successfully been used to help diabetics improve blood sugar levels and put diabetes into remission, Narang told CNN. Ozempic is the most potent of all the GLP-1 medications, she said.

Behind the brand name Ozempic is the medication semaglutide. While Ozempic is used primarily to treat Type 2 diabetes, another drug by the name Wegovy — also semaglutide — is approved specifically for chronic weight management.

Although approved by the FDA in 2021, Wegovy was not readily available through most of last year, according to Narang, so people turned to Ozempic. According to the FDA drug shortages database, Wegovy was undersupplied starting at the end of last March but came back in stock earlier this year.

Social media buzz around the two drugs took off at the start of 2023. Celebrities shared their testimonies about how semaglutide helped them shed unwanted pounds. Elon Musk, for example, publicly credited Ozempic and Wegovy in part for his weight loss.

#Ozempic and #Wegovy have been “extremely popular” over the last few months on TikTok, according to company analytics.

The use of Ozempic and Wegovy for short-term weight loss has resulted in real consequences for patients who need the drugs most for diabetes treatment and chronic weight management, said Narang. For example, some insurance companies in the past have reportedly refused to cover Wegovy, one calling it a “vanity drug.”

Both drugs are intended for long-term use, not for short-term weight loss. Their appetite-regulating effects wear off quickly after you stop taking them.

“This is not meant to be a medication to take off your last five or 10 pounds to get ready for an event or something like that. It’s not for use of three or four weeks,” Narang said. “When we think about weight management, we’re thinking about the next 25 years of someone’s life.”



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March 18, 2023

Chronic pain patients struggle to get opioid prescriptions filled, even as CDC eases guidelines | CNN

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KHN
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Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,” said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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March 8, 2023

Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

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For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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March 4, 2023

A shortage of albuterol is about to get worse, especially in hospitals | CNN

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CNN
— 

An ongoing shortage of a medicine commonly used to treat people with breathing problems is expected to get worse after a major supplier to US hospitals shut down last week.

Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. It has been on the US Food and Drug Administration’s shortages list since October. The news of the plant shutdown worries some doctors who work with patients with breathing problems such as asthma.

“This is definitely concerning, especially as we are coming out of the respiratory season where we had a big demand with RSV, Covid-19 and flu, and are now heading into spring allergy season when a lot of kids and adults experience asthma symptoms,” said Dr. Juanita Mora, a national volunteer medical spokesperson for the American Lung Association and an allergist/immunologist based in Chicago. “This is a life-saving drug and being able to breathe is vital for everyone.”

The manufacturer that recently shut down, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.

It was the only company to make certain albuterol products used for continuous nebulizer treatment. It’s a staple in children’s hospitals, but had been out of stock since last fall. Without that particular form of the product, hospitals have had to scramble to find alternatives.

“Members are either forced to compound it themselves to make the product or go to an outside third party source who is compounding the product,” said Paula Gurz, senior director of pharmacy contracting with Premier Inc., a major group purchasing company for hospitals.

With the Akorn shutdown, Gurz said products from the one remaining major domestic source of liquid albuterol, Nephron Pharmacuticals, have been on back order. Nephron just started shipping albuterol last Friday, Gurz said, but to get back on track, “it’s going to be an uphill climb.”

Hospitals around the country said they’re watching the supply chain – and their current stock – closely. There’s concern they might have to delay discharging patients because they don’t have enough medicine, or that they may see more ER visits for people with breathing problems who don’t have access to medicine.

Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital has been largely unaffected so far, but for months she has heard about retail pharmacies and other health systems that have had issues with albuterol shortages.

“The big problem we’ve been hearing about is inhalation solutions, not really the inhalers, it’s more like the solutions that go into the nebulizer machines for inhalation that the patients breath in,” said Piper.

Without the larger Akorn product, staff at Lurie Children’s Hospital in Chicago had to squeeze out the albuterol contents from smaller packages.

It’s “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day),” said hospital spokesperson Julianne Bardele in an email.

When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different concentration and use an alternative liquid bronchodilator, levalbuterol.

Most hospital pharmacies are aware of supply issues for many medicines, particularly pediatric medicines, said T.J. Grimm, the director of retail and ambulatory services at University Hospitals Cleveland Medical Center, and they try to keep a higher stock – especially of the less expensive medicines like albuterol.

“Just so we can cover situations like this,” Grimm said.

Grimm said his system has albuterol supply for a couple of months still, but he’s frustrated and concerned about the supply chain.

“When you have supply chains that are just-in-time, it can create some issues with when something goes off,” Grimm added. “There’s the short-term crisis we all have to get through and then there’s a longer term. We need to think about these things a little more strategically, especially with our kids.”

Jerrod Milton, the chief clinical officer at Children’s Hospital Colorado, said they’ve been paying close attention to the albuterol shortages for many months. The hospital has experienced shortages in the past, and has continued to implement protocols to conserve doses.

“Challenges are what we deal with when it comes to pediatric medicine. We consider most of the kids that we take care of as somewhat therapeutic orphans,” Milton said. “It’s just another one of the myriad of shortages that we have to deal with, I guess.”

Jessica Daley, the group vice president of strategic sourcing for Premier, said that she doesn’t anticipate that the albuterol shortage will be an ongoing problem for years, but when the market has only a handful of suppliers, “it makes for a very tight market, a very concerning market right now.”

Daley said there are things hospitals can do to help, such as protocol changes, making products on site and finding different suppliers.

The Children’s Hospital Association stepped in to help when it heard from members having difficulty finding enough supply. The association worked with STAQ Pharma, a facility that provides compounded pediatric medication, to start production on batches of albuterol for children’s hospitals in the sizes they needed.

“We’ve been creative and trying to work proactively. So when we think there’s going to be a problem, we’re trying to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.

STAQ should be at full production by May, so hospitals will have a steady, stable supply ahead of the next season in which respiratory viruses are in wide circulation, the association says.

Daley at Premier said that in an ideal world, there would be more suppliers of these products, particularly with generic drugs, so that when there is a problem with one, the market could handle it. When there is a concentration of manufacturing with a small number of suppliers, it is very hard to recover, she said.

“We really advocate for diversity and supply to prevent types these types of issues,” Daley said. “Meaning at least three globally, geographically diverse suppliers that are supplying the market with sufficient products.”

For patients, Piper at Children’s Hospital of New Orleans said they are encouraging patients with breathing problems to take precautions and avoid asthma triggers if possible. She said if a patient’s usual pharmacy runs out, it’s also good to check with a doctor to see if there is another medication that’s available.

Inhalers don’t seem to be impacted by the shortage so far, but Daley said if people panic about the lack of albuterol for hospitals, that could change.

“Albuterol is one of those things that if there’s a patient who needs it, you want to have it all the time. So there’s always that potential for the market to respond and react in a way that that will then create downstream shortages of other sizes or presentations of a product,” Daley said.

To avoid that problem, Milton at Children’s Hospital Colorado said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”

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March 3, 2023

Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes | CNN

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CNN
— 

Eli Lilly announced Wednesday a series of price cuts that would lower the price of the most commonly used forms of its insulin 70% and said it will automatically cap out-of-pocket insulin costs at $35 for people who have private insurance and use participating pharmacies.

Lilly says it will also expand its Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured.

President Joe Biden heralded the announcement as “a big deal.”

“For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It’s flat wrong,” Biden said in a statement on Wednesday.

The President also urged other pharmaceutical companies to cut insulin prices.

“Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that. It’s a big deal, and it’s time for other manufacturers to follow,” Biden said.

Eli Lilly says it will cut the list price of its nonbranded insulin to $25 a vial as of May 1, making it the lowest list-priced mealtime insulin available. Its current list price is $82.41 for a vial.

Lilly will also lower the list price of Humulin and its most commonly prescribed insulin, Humalog, in the fourth quarter of 2023. The current list price of a Humalog vial is $274.70, and the new list price will be $66.40. For people with commercial insurance who use participating pharmacies, the out-of-pocket costs will now be capped at $35.

Although insulin is relatively inexpensive to manufacture, the cost has been a problem for many Americans for years. At least 16.5% of people in the US who use it report rationing it because of cost.

The average price of insulin nearly tripled between 2002 and 2013, the American Diabetes Association says. GoodRx research shows that the trend has continued, with the average retail price of insulin rising 54% between 2014 and 2019.

Demand for insulin has grown significantly as diabetes has become the fastest-growing chronic disease in the world, a 2022 study found.

In the US alone, the number of adults with diabetes has doubled over the past 20 years, and more than 37.3 million people now have it, according to the US Centers for Disease Control and Prevention. Another 96 million Americans – 38% of the population – have prediabetes, a condition in which blood sugar levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. This can often lead to diabetes.

People with diabetes rely on insulin because their bodies have stopped producing enough of this hormone or aren’t using it efficiently to convert food into energy.

When a person eats, their body breaks down food, mostly into sugar. This sugar enters the bloodstream, and that signals the pancreas to release insulin, which works like a key that allows the sugar to energize cells. But if diabetes keeps sugar in the bloodstream for too long, it can lead to serious problems like kidney disease, heart problems and blindness. In 2019, diabetes was the seventh leading cause of death in the US, according to the American Diabetes Association.

This year’s Inflation Reduction Act capped insulin costs for seniors who get their health coverage through Medicare Part D at $35 a month. Congressional Democrats pushed to extend that price cap to people covered by private insurance, but Republicans stripped that measure from the bill.

The US Food and Drug Administration’s approvals of generic insulin and biosimilars – drugs similar to original versions that can be made differently or with slightly different substances – have driven down the price at least somewhat, according to GoodRx.

Some states have taken matters into their own hands. Twenty-two states and the District of Columbia have price caps ranging from $25 to $100 for insulin as well as diabetes supplies and devices – but that’s only for people covered by insurance plans regulated by those states.

“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap.”

Lilly has been one of the biggest players in the US insulin market since it became the first company to commercialize the lifesaving drug 100 years ago. The company said that its price changes should make a difference, but more is needed to help all Americans with diabetes – 7 out of 10 don’t use the company’s insulin.

The Medicare Part D cap “should be the new standard in America,” Ricks said on CNN This Morning on Wednesday.

He called on the insurance industry, policymakers and other manufacturers to join them in making insulin more affordable.

“We call on everyone to meet us at this point and take this issue away from a disease that’s stressful and difficult to manage already – to take away the affordability challenges,” Ricks told CNN’s Don Lemon.

Other companies have cut insulin costs over the years.

In 2019, Sanofi created the Insulin Valyou Savings Program, which charged patients $99 a month for insulin, regardless of income. In 2021, Novo Nordisk created a similar program called My$99Insulin.

Also that year, Novo Nordisk collaborated with Walmart to sell private-label analog insulin at a deep discount. Walmart said its ReliOn NovoLog vials and FlexPens save customers 58% to 75% off the cash price for branded insulin.

For Eli Lilly insulin, the new price cap will automatically apply at most pharmacies with no additional action from the patient. Otherwise, a coupon will be available for patients to use at the remaining 15% of pharmacies where the electronic system does not allow for the automatic price drop, Ricks said.

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March 1, 2023

11 minutes of daily exercise could have a positive impact on your health, large study shows | CNN

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CNN
— 

When you can’t fit your entire workout into a busy day, do you think there’s no point in doing anything at all? You should rethink that mindset. Just 11 minutes of moderate-to-vigorous intensity aerobic activity per day could lower your risk of cancer, cardiovascular disease or premature death, a large new study has found.

Aerobic activities include walking, dancing, running, jogging, cycling and swimming. You can gauge the intensity level of an activity by your heart rate and how hard you’re breathing as you move. Generally, being able to talk but not sing during an activity would make it moderate intensity. Vigorous intensity is marked by the inability to carry on a conversation.

Higher levels of physical activity have been associated with lower rates of premature death and chronic disease, according to past research. But how the risk levels for these outcomes are affected by the amount of exercise someone gets has been more difficult to determine. To explore this impact, scientists largely from the University of Cambridge in the United Kingdom looked at data from 196 studies, amounting to more than 30 million adult participants who were followed for 10 years on average. The results of this latest study were published Tuesday in the British Journal of Sports Medicine.

The study mainly focused on participants who had done the minimum recommended amount of 150 minutes of exercise per week, or 22 minutes per day. Compared with inactive participants, adults who had done 150 minutes of moderate-to-vigorous aerobic physical activity per week had a 31% lower risk of dying from any cause, a 29% lower risk of dying from cardiovascular disease and a 15% lower risk of dying from cancer.

The same amount of exercise was linked with a 27% lower risk of developing cardiovascular disease and 12% lower risk when it came to cancer.

“This is a compelling systematic review of existing research,” said CNN Medical Analyst Dr. Leana Wen, an emergency physician and public health professor at George Washington University, who wasn’t involved in the research. “We already knew that there was a strong correlation between increased physical activity and reduced risk for cardiovascular disease, cancer and premature death. This research confirms it, and furthermore states that a smaller amount than the 150 minutes of recommended exercise a week can help.”

Even people who got just half the minimum recommended amount of physical activity benefited. Accumulating 75 minutes of moderate-intensity activity per week — about 11 minutes of activity per day — was associated with a 23% lower risk of early death. Getting active for 75 minutes on a weekly basis was also enough to reduce the risk of developing cardiovascular disease by 17% and cancer by 7%.

Beyond 150 minutes per week, any additional benefits were smaller.

“If you are someone who finds the idea of 150 minutes of moderate-intensity physical activity a week a bit daunting, then our findings should be good news,” said study author Dr. Soren Brage, group leader of the Physical Activity Epidemiology group in the Medical Research Council Epidemiology Unit at the University of Cambridge, in a news release. “This is also a good starting position — if you find that 75 minutes a week is manageable, then you could try stepping it up gradually to the full recommended amount.”

The authors’ findings affirm the World Health Organization’s position that doing some physical activity is better than doing none, even if you don’t get the recommended amounts of exercise.

“One in 10 premature deaths could have been prevented if everyone achieved even half the recommended level of physical activity,” the authors wrote in the study. Additionally, “10.9% and 5.2% of all incident cases of CVD (cardiovascular disease) and cancer would have been prevented.”

Important note: If you experience pain while exercising, stop immediately. Check with your doctor before beginning any new exercise program.

The authors didn’t have details on the specific types of physical activity the participants did. But some experts do have thoughts on how physical activity could reduce risk for chronic diseases and premature death.

“There are many potential mechanisms including the improvement and maintenance of body composition, insulin resistance and physical function because of a wide variety of favorable influences of aerobic activity,” said Haruki Momma, an associate professor of medicine and science in sports and exercise at Tohoku University in Japan. Momma wasn’t involved in the research.

Benefits could also include improvement to immune function, lung and heart health, inflammation levels, hypertension, cholesterol, and amount of body fat, said Eleanor Watts, a postdoctoral fellow in the division of cancer epidemiology and genetics at the National Cancer Institute. Watts wasn’t involved in the research.

“These translate into lower risk of getting chronic diseases,” said Peter Katzmarzyk, associate executive director for population and public health sciences at Pennington Biomedical Research Center in Baton Rouge, Louisiana. Katzmarzyk wasn’t involved in the research.

The fact that participants who did only half the minimum recommended amount of exercise still experienced benefits doesn’t mean people shouldn’t aim for more exercise, but rather that “perfect shouldn’t be the enemy of the good,” Wen said. “Some is better than none.”

To get up to 150 minutes of physical activity per week, find activities you enjoy, Wen said. “You are far more likely to engage in something you love doing than something you have to make yourself do.”

And when it comes to how you fit in your exercise, you can think outside the box.

“Moderate activity doesn’t have to involve what we normally think of (as) exercise, such as sports or running,” said study coauthor Leandro Garcia, a lecturer in the school of medicine, dentistry and biomedical sciences at Queen’s University Belfast, in a news release. “Sometimes, replacing some habits is all that is needed.

“For example, try to walk or cycle to your work or study place instead of using a car, or engage in active play with your kids or grand kids. Doing activities that you enjoy and that are easy to include in your weekly routine is an excellent way to become more active.”

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February 27, 2023

Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN

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CNN
— 

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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February 21, 2023

Dementia risk rises if you live with chronic pain, study says | CNN

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CNN
— 

Chronic pain, such as arthritis, cancer or back pain, lasting for over three months, raises the risk of cognitive decline and dementia, a new study found.

The hippocampus, a brain structure highly associated with learning and memory, aged by about a year in a 60-year-old person who had one site of chronic pain compared with people with no pain.

When pain was felt in two places in the body, the hippocampus shrank even more — the equivalent of just over two years of aging, according to estimates in the study published Monday in the journal Proceedings of the National Academy of Sciences, or PNAS.

“In other words, the hippocampal (grey matter volume) in a 60-y-old individual with (chronic pain) at two body sites was similar to the volume of (pain free) controls aged 62-y-old,” wrote corresponding author Tu Yiheng and his colleagues. Tu is a professor of psychology at the Chinese Academy of Sciences in Beijing.

The risk rose as the number of pain sites in the body increased, the study found. Hippocampal volume was nearly four times smaller in people with pain in five or more body sites compared with those with only two — the equivalent of up to eight years of aging.

“Asking people about any chronic pain conditions, and advocating for their care by a pain specialist, may be a modifiable risk factor against cognitive decline that we can proactively address,” said Alzheimer’s disease researcher Dr. Richard Isaacson, a preventive neurologist at the Institute for Neurodegenerative Diseases of Florida. He was not involved in the new study.

The study analyzed data from over 19,000 people who had undergone brain scans as part of the UK Biobank, a long-term government study of over 500,000 UK participants between the ages of 40 and 69.

People with multiple sites of body pain performed worse than people with no pain on seven of 11 cognitive tasks, the study found. In contrast, people with only one pain site performed worse on only one cognitive task — the ability to remember to perform a task in the future.

The study controlled for a variety of contributing conditions — age, alcohol use, body mass, ethnicity, genetics, history of cancer, diabetes, vascular or heart problems, medications, psychiatric symptoms and smoking status, to name a few. However, the study did not control for levels of exercise, Isaacson said.

“Exercise is the #1 most powerful tool in the fight against cognitive decline and dementia,” he said via email. “People affected by multisite chronic pain may be less able to adhere to regular physical activity as one potential mechanism for increased dementia risk.”

Equally important is a link between chronic pain and inflammation, Isaacson said. A 2019 review of studies found pain triggers immune cells called microglia to create neuroinflammation that may lead to changes in brain connectivity and function.

People with higher levels of pain were also more likely to have reduced gray matter in other brain areas that impact cognition, such as the prefrontal cortex and frontal lobe — the same areas attacked by Alzhemier’s disease. In fact, over 45% of Alzheimer’s patients live with chronic pain, according to a 2016 study cited by the review.

The study was also not able to determine sleep deficits — chronic pain often makes getting a good night’s sleep difficult. A 2021 study found sleeping less than six hours a night in midlife raises the risk of dementia by 30%.

Globally, low back pain is a leading cause of years lived with disability, with neck pain coming in at No. 4, according to the 2016 Global Burden of Disease Study. Arthritis, nerve damage, pain from cancer and injuries are other leading causes.

Researchers estimate over 30% of people worldwide suffer with chronic pain: “Pain is the most common reason people seek health care and the leading cause of disability in the world,” according to articles published in the journal The Lancet in 2021.

In the United States alone, at least 1 in 5 people, or some 50 million Americans, live with long-lasting pain, according to the US Centers for Disease Control and Prevention.

Nearly 11 million Americans suffer from high-impact chronic pain, defined as pain lasting over three months that’s “accompanied by at least one major activity restriction, such as being unable to work outside the home, go to school, or do household chores,” according to the National Center for Complementary and Integrative Health.

Chronic pain has been linked to anxiety, depression, restrictions in mobility and daily activities, dependence on opioids, increased health care costs, and poor quality of life. A 2019 study estimated about 5 million to 8 million Americans were using opioids to manage chronic pain.

Pain management programs typically involve a number of specialists to find the best relief for symptoms while providing support for the emotional and mental burden of pain, according to John Hopkins Medicine.

Medical treatment can include over-the-counter and prescription medications to stop the pain cycle and ease inflammation. Injections of steroids may also help. Antidepressants increase the amount of serotonin, which controls part of the pain pathway in the brain. Applying brief bursts of electricity to the muscles and nerve endings is another treatment.

Therapies such as massage and whirlpool immersion and exercises may be suggested by occupational and physical therapists. Hot and cold treatments and acupuncture may help as well.

Psychologists who specialize in rehabilitation may recommend cognitive and relaxation techniques such as meditation, tai chi and yoga that can take the mind off fixating on pain. Cognitive behavioral therapy is a key psychological treatment for pain.

Going on an anti-inflammatory diet may be suggested, such as cutting back on trans fats, sugars and other processed foods. Weight loss may be helpful as well, especially for back and knee pain, according to Johns Hopkins.

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February 6, 2023

Alcohol and dementia: Study finds benefits in minimal drinking, but it’s complicated | CNN

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CNN
— 

Keeping alcohol consumption to one or two drinks a day lessened the odds of developing dementia, according to a study of nearly 4 million South Koreans.

However, drinking more than two drinks a day increased that risk, according to the study published Monday in the journal JAMA Network Open.

“We found that maintaining mild to moderate alcohol consumption as well as reducing alcohol consumption from a heavy to moderate level were associated with a decreased risk of dementia,” said first author Dr. Keun Hye Jeon, an assistant professor at CHA Gumi Medical Center, CHA University in Gumi, South Korea, in an email.

But don’t rush to the liquor store, experts say.

“This study was well done and is extremely robust with 4 million subjects, but we should be cautious not to over interpret the findings,” said Alzheimer’s researcher Dr. Richard Isaacson, a preventive neurologist at the Institute for Neurodegenerative Diseases of Florida. He was not involved in the new study.

Alcohol use can be a risk factor for breast and other cancers, and consuming too much can contribute to digestive problems, heart and liver disease, hypertension, stroke, and a weak immune system over time, according to the US Centers for Disease Control and Prevention.

There are red flags for Alzheimer’s as well. For example, if a person has one or two copies of the APOE4 gene variant, which raises your risk of developing the mind-wasting disease, drinking is not a good choice, Isaacson said.

“Alcohol has been shown to be harmful for brain outcomes in people with that risk gene — and about 25% of the US population carries one copy of APOE4,” he said.

The new study examined the medical records of people covered by the Korean National Health Insurance Service (NHIS), which provides a free health exam twice a year to insured South Koreans who are 40 and older. In addition to doing various tests, examiners asked about each person’s drinking, smoking and exercise habits.

The study looked at the data collected in 2009 and 2011 and categorized people by their self-reported drinking levels. If a person said they drank less than 15 grams (approximately 0.5 ounces) of alcohol a day, they were considered “mild” drinkers.

In the United States, a standard drink contains 14 grams of alcohol, which is roughly the same as 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of distilled spirits.

If study participants told doctors they drank 15 to 29.9 grams a day — the equivalent of two standards drinks in the US — the researchers categorized them as “moderate” drinkers. And if people said they drank over 30 grams, or three or more drinks a day, researchers considered them “heavy” drinkers.

Researchers also looked at whether people sustained or changed the amount they drank between 2009 and 2011, Jeon said.

“By measuring alcohol consumption at two time points, we were able to study the relationship between reducing, ceasing, maintaining and increasing alcohol consumption and incident dementia,” he said.

The team then compared that data to medical records in 2018 — seven or eight years later — to see if anyone studied had been diagnosed with dementia.

After adjusting for age, sex, smoking, exercise level and other demographic factors, researchers found people who said they drank at a mild level over time — about a drink a day — were 21% less likely to develop dementia than people who never drank.

People who said they continued to drink at moderate level, or about two drinks a day, were 17% less likely to develop dementia, the study found.

“One has to be cautious when interpreting studies using medical records. They can be fraught with challenges in how diseases are coded and studied,” Isaacson said. “Any anytime you ask people to recall their behaviors, such as drinking, it leaves room for memory errors.”

The positive pattern did not continue as drinking increased. People who drank heavily — three or more drinks a day — were 8% more likely to be diagnosed with dementia, the study found.

If heavy drinkers reduced their drinking over time to a moderate level, their risk of being diagnosed with Alzheimer’s fell by 12%, and the risk of all-cause dementia fell by 8%.

However, people aren’t very good at judging how much alcohol they are drinking, Isaacson said.

“People don’t really monitor their pours of wine, for example,” Isaacson said. “They may think they are drinking a standard-sized glass of wine, but it’s really a glass and a half every time. Drink two of those pours and they’ve had three glasses of wine. That’s no longer mild or moderate consumption.”

In addition, too many people who think they are moderate drinkers do all of their drinking on weekends. Binge drinking is on the rise worldwide, even among adults, studies show.

“If someone downs five drinks on Saturday and Sunday that’s 10 drinks a week so that would qualify as a moderate alcohol intake,” Isaacson said. “To me, that is not that is not the same as having a glass of wine five days a week with a meal, which slows consumption.”

The new study also found that starting to drink at a mild level was associated with a decreased risk of all-cause dementia and Alzheimer’s, “which, to our knowledge, has never been reported in previous studies,” the authors wrote.

However, “none of the existing health guidelines recommends starting alcohol drinking,” Jeon said, adding that since the study was observational, no cause and effect can be determined.

“Our findings regarding a initiation of mild alcohol consumption cannot be directly translated into clinical recommendations, thereby warranting additional studies to confirm these associations further,” Jeon said.

A study published in March 2022 found that just one pint of beer or glass of wine a day can shrink the overall volume of the brain, with the damage increasing as the number of daily drinks rises.

On average, people between 40 and 69 who drank a pint of beer or 6-ounce glass of wine per day for a month had brains that appeared two years older than those who only drank half of a beer, according to that previous study.

“I’ve never personally suggested someone to start drinking moderate amounts of alcohol if they were abstinent,” Isaacson said. “But there’s really not a one-size-fits-all approach towards counseling a patient on alcohol consumption.”

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January 30, 2023

Weight loss surgery extends lives, study finds | CNN

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CNN
— 

Weight loss surgery reduces the risk of premature death, especially from such obesity-related conditions as cancer, diabetes and heart disease, according to a new 40-year study of nearly 22,000 people who had bariatric surgery in Utah.

Compared with those of similar weight, people who underwent one of four types of weight loss surgery were 16% less likely to die from any cause, the study found. The drop in deaths from diseases triggered by obesity, such as heart disease, cancer and diabetes, was even more dramatic.

“Deaths from cardiovascular disease decreased by 29%, while deaths from various cancers decreased by 43%, which is pretty impressive,” said lead author Ted Adams, an adjunct associate professor in nutrition and integrative physiology at the University of Utah’s School of Medicine.

“There was also a huge percentage drop — a 72% decline — in deaths related to diabetes in people who had surgery compared to those who did not,” he said. One significant downside: The study also found younger people who had the surgery were at higher risk for suicide.

The study, published Wednesday in the journal Obesity, reinforces similar findings from earlier research, including a 10-year study in Sweden that found significant reductions in premature deaths, said Dr. Eduardo Grunvald, a professor of medicine and medical director of the weight management program at the University of California San Diego Health.

The Swedish study also found a significant number of people were in remission from diabetes at both two years and 10 years after surgery.

“This new research from Utah is more evidence that people who undergo these procedures have positive, beneficial long-term outcomes,” said Grunvald, who coauthored the American Gastroenterological Association’s new guidelines on obesity treatment.

The association strongly recommends patients with obesity use recently approved weight loss medications or surgery paired with lifestyle changes.

“And the key for patients is to know that changing your diet becomes more natural, more easy to do after you have bariatric surgery or take the new weight loss medications,” said Grunvald, who was not involved in the Utah study.

“While we don’t yet fully understand why, these interventions actually change the chemistry in your brain, making it much easier to change your diet afterwards.”

Despite the benefits though, only 2% of patients who are eligible for bariatric surgery ever get it, often due to the stigma about obesity, said Dr. Caroline Apovian, a professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian was the lead author for the Endocrine Society’s clinical practice guidelines for the pharmacological management of obesity.

Insurance carriers typically cover the cost of surgery for people over 18 with a body mass index of 40 or higher, or a BMI of 35 if the patient also has a related condition such as diabetes or high blood pressure, she said.

“I see patients with a BMI of 50, and invariably I will say, ‘You’re a candidate for everything — medication, diet, exercise and surgery.’ And many tell me, ‘Don’t talk to me about surgery. I don’t want it.’ They don’t want a surgical solution to what society has told them is a failure of willpower,” she said.

“We don’t torture people who have heart disease: ‘Oh, it’s because you ate all that fast food.’ We don’t torture people with diabetes: ‘Oh, it’s because you ate all that cake.’ We tell them they have a disease, and we treat it. Obesity is a disease, too, yet we torture people with obesity by telling them it’s their fault.”

Most of the people who choose bariatric surgery — around 80% — are women, Adams said. One of the strengths of the new study, he said, was the inclusion of men who had undergone the procedure.

“For all-causes of death, the mortality was reduced by 14% for females and by 21% for males,” Adams said. In addition, deaths from related causes, such as heart attack, cancer and diabetes, was 24% lower for females and 22% lower for males who underwent surgery compared with those who did not, he said.

Four types of surgery performed between 1982 and 2018 were examined in the study: gastric bypass, gastric banding, gastric sleeve and duodenal switch.

Gastric bypass, developed in the late 1960s, creates a small pouch near the top of the stomach. A part of the small intestine is brought up and attached to that point, bypassing most of the stomach and the duodenum, the first part of the small intestine.

In gastric banding, an elastic band that can be tightened or loosened is placed around the top portion of the stomach, thus restricting the volume of food entering the stomach cavity. Because gastric banding is not as successful in creating long-term weight loss, the procedure “is not as popular today,” Adams said.

“The gastric sleeve is a procedure where essentially about two-thirds of the stomach is removed laparoscopically,” he said. “It takes less time to perform, and food still passes through the much-smaller stomach. It’s become a very popular option.”

The duodenal switch is typically reserved for patients who have a high BMI, Adams added. It’s a complicated procedure that combines a sleeve gastrectomy with an intestinal bypass, and is effective for type 2 diabetes, according to the Cleveland Clinic.

One alarming finding of the new study was a 2.4% increase in deaths by suicide, primarily among people who had bariatric surgery between the ages of 18 and 34.

“That’s because they are told that life is going to be great after surgery or medication,” said Joann Hendelman, clinical director of the National Alliance for Eating Disorders, a nonprofit advocacy group.

“All you have to do is lose weight, and people are going to want to hang out with you, people will want to be your friend, and your anxiety and depression are going to be gone,” she said. “But that’s not reality.”

In addition, there are postoperative risks and side effects associated with bariatric surgery, such as nausea, vomiting, alcoholism, a potential failure to lose weight or even weight gain, said Susan Vibbert, an advocate at Project HEAL, which provides help for people struggling with eating disorders.

“How are we defining health in these scenarios? And is there another intervention — a weight neutral intervention?” Vibbert asked.

Past research has also shown an association between suicide risk and bariatric surgery, Grunvald said, but studies on the topic are not always able to determine a patient’s mental history.

“Did the person opt for surgery because they had some unrealistic expectations or underlying psychological disorders that were not resolved after the surgery? Or is this a direct effect somehow of bariatric surgery? We can’t answer that for sure,” he said.

Intensive presurgery counseling is typically required for all who undergo the procedure, but it may not be enough, Apovian said. She lost her first bariatric surgery patient to suicide.

“She was older, in her 40s. She had surgery and lost 150 pounds. And then she put herself in front of a bus and died because she had underlying bipolar disorder she had been self-medicating with food,” Apovian said. “We as a society use a lot of food to hide trauma. What we need in this country is more psychological counseling for everybody, not just for people who undergo bariatric surgery.”

Managing weight is a unique process for each person, a mixture of genetics, culture, environment, social stigma and personal health, experts say. There is no one solution for all.

“First, we as a society must consider obesity as a disease, as a biological problem, not as a moral failing,” Grunvald said. “That’s my first piece of advice.

“And if you believe your life is going to benefit from treatment, then consider evidence-based treatment, which studies show are surgery or medications, if you haven’t been able to successfully do it with lifestyle changes alone.”

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