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Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

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CNN
—

The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

“This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

And in some cases, people might not even know that xylazine was in the drug they used.

Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

“Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

“We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

“Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

“All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

Addicted? How to get help

If you’re addicted to prescription drugs, help is available. You can call the Substance Abuse Mental Health Services Administration 24/7 hotline at 1-800-662-HELP(4357) or visit their website.

But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

US lawmakers are moving to classify xylazine as a controlled substance.

In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

“Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

“This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

“It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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FDA approves first over-the-counter version of opioid overdose antidote Narcan | CNN

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CNN
—

With drug overdose deaths continuing to hover near record levels, the US Food and Drug Administration on Wednesday approved for the first time an over-the-counter version of the opioid overdose antidote Narcan.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Dr. Robert Califf said in a statement.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy, said accessibility is key to ensuring that the Narcan nasal spray saves lives.

“It’s really important that we continue to do everything possible in our power to make this life-saving drug available to anyone and everyone across the country,” Gupta said.

The White House drug czar said businesses, such as restaraunts and banks, and schools will be encouraged to purchase over-the-counter naloxone.

“We will encourage businesses, restaurants, banks, construction sites, schools, others to think about this – think about it as a smoke alarm or a defibrillator, to make it as easily accessible, because it’s not just you. It could be your neighbor, it could be your family, your friend, a person at work or school who might need it, ” Gupta said.

The nasal spray will come in a package of two 4-milligram doses, in case the person overdosing does not respond to the first dose. However, the drug’s maker, Emergent BioSolutions, says most overdoses can be reversed with a single dose. The product could be given to anyone, even children and babies.

The nasal spray is expected to be available for purchase in stores and online by late summer, Emergent said Wednesday.

More than a million people have died of drug overdoses in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Many of those deaths were due to opioids. Deaths from opioid overdoses rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Opioid deaths are the leading cause of accidental death in the US. Most are among adults, but children are also dying, largely after ingesting synthetic opioids such as fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Nearly every state in the US has standing orders that allow pharmacists or other qualified organizations to provide the medication without a personal prescription to people who are at risk of an overdose or are helping someone at risk, but making it available over the counter can make it easier for people to access the opioid antidote.

Research shows that wider availability could save lives as opioid overdoses have skyrocketed in recent years – much of it due to synthetic opioids like illicitly made fentanyl.

Emergent President and CEO Robert Kramer hailed the FDA’s decision as a “historic milestone.”

“We are dedicated to improving public health and assisting those working hard to end the opioid crisis – so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan Nasal Spray to help save a life,” Kramer said in a statement.

Narcan works by blocking the effects of opioids on the brain and restoring breathing. For the most effectiveness, it must be given as soon as signs of overdose appear.

The drug works on someone only if there are opioids in their system. It won’t work on any other type of drug overdose, but it won’t have adverse effects if given to someone who hasn’t taken opioids.

Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important to call 911 after giving the drug.

People given naloxone should be watched carefully until medical help arrives and monitored for another two hours.

About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Emergent said it does not have information on how much OTC Narcan will cost.

Harm reduction experts say the price of naloxone has inhibited its accessibility to people who need it most. And although the cost will probably drop as it becomes available over the counter, they say it will probably still be out of reach for many.

“We’re not going to be able to ramp up naloxone distribution in a game-changing way until we get a better handle on the price,” said Nabarun Dasgupta, a scientist at the University of North Carolina’s Injury Prevention Research Center who studies drugs and infectious diseases. “There’s the promise on paper versus on the street, and it’s going to come down to the dollars and cents.”

Separate changes to grant funding by both the CDC and the Substance Abuse and Mental Health Services Administration will make it easier for states and local health departments to buy naloxone, he said.

Gupta said the Biden administration is asking the drugmakers to keep the price of the antidote low.

“That’s one of the things that the president has been very clear: that we’ve got to make sure that these life-saving medications, as well as treatment, is accessible across no matter where you live, rural or urban, rich or poor. We want to make sure this is accessible across broad swaths of people,” he said.

However, experts said the most meaningful work in the fight against the devastating outcomes of the drug overdose epidemic will come with ongoing emphasis on treatment for opioid use disorder and other harm-reduction strategies.

“While enabling people to access quality treatment for substance use disorders is critical, we must also acknowledge that people need to survive in order to have that choice,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, said in January.

Caleb Banta-Green, principal research scientist at the University of Washington’s Addictions, Drug & Alcohol Institute, has described naloxone as the “gateway drug” to a conversation about what substance use disorder is.

“It’s a conversation starter. It’s life-saving for the individual. It’s not a game-changer at the population level,” he said. “We need to do more. And we need to use treatment medications – methadone and buprenorphine – which are far higher overdose preventive approaches.”

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New drug shortages in the US increased nearly 30% in 2022, Senate report finds | CNN

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CNN
—

When a pharmaceutical plant in Shanghai that made contrast material for radiological scans shut down last year, half the United States’ supply of the radioactive substance immediately became unavailable. Health care providers had to make difficult choices about who got potentially lifesaving tests.

“I work in the VA system. This impacted veterans literally overnight, where we needed to make decisions about whether we were going to allow some scans to be done to evaluate someone’s cancer or treat someone’s heart disease,” said Dr. Andrew Shuman, a head and neck surgeon who works at the US Department of Veterans Affairs and is an associate professor at University of Michigan Health. “Veterans deserve better and we should not be reliant on a supply chain that’s that tenuous.”

Shuman was one of several experts who testified Wednesday in front of the US Senate’s Homeland Security and Governmental Affairs Committee that shortages like these make the US drug and medical supply far too vulnerable and put national security at risk.

New drug shortages in the US increased nearly 30% between 2021 and 2022, according to a report commissioned by the Senate that was published Wednesday. At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages, according to the report. It also found that while the average drug shortage lasts about 1.5 years, more than 15 critical drug products have been in shortage for over a decade.

Many Americans became aware of national shortages during the Covid-19 pandemic. In one of the most notable examples last year, anxious parents reported going from store to store in search of common pain relievers and antibiotics during an especially rough RSV season.

Increased demand can cause shortages, but the way drugs are made and sold for the US market is also a large part of the problem, the experts said Wednesday.

Shortages of common and specialized drugs have been a constant for decades, the report says.

“Since 2007, the FDA identified an average of over 100 separate drug shortages per year. In 2011, the FDA identified a whopping 267 drugs in short supply and despite possessing the most innovative medical industry in the world, the US is unable to maintain a consistent supply of the most crucial medicines,” ranking committee member Sen. Rand Paul, R-Kentucky, said at the hearing.

Under the current regulatory system, the problem won’t probably get better any time soon, the experts said.

“Even drugs needed to treat childhood and adult cancers, including some that have simply no alternative treatment, are regularly in shortage. And while some shortages may only be an inconvenience, others have had devastating impacts on patient care,” said Sen. Gary Peters, D-Michigan, who commissioned the new report.

At its peak last year, there were 295 drugs in shortage, Peters said. In years past, the number has been even higher. The US Food and Drug Administration currently lists 130 drugs in shortage.

Some common medications like Adderall have been on the list for months. Many others like albuterol sulfate, which doctors use to treat breathing problems, are a staple in hospitals.

Albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists, and it’s been on the FDA shortage list since October. That particular shortage is expected to get even worse because a major supplier to US hospitals shut down at the beginning of March.

The albuterol shortage shows how consolidation in the market has been a real problem for a number of drugs, experts say. In a consolidated market, labor issues and manufacturing disruptions can make drugs particularly hard to find.

Only one company made certain albuterol products used for continuous nebulizer treatment. The manufacturer that shut down, Akorn Operating Co., filed for Chapter 11 bankruptcy in May 2020.

Lower-priced drugs, generics like albuterol and certain antibiotics like amoxicillin tend to have a higher likelihood of being in shortage, according to an analysis presented at the hearing by US Pharmacopeia, a nonprofit that works to strengthen the global supply chain of medicines and publishes a set of guidelines for medicines. Economics is largely to blame.

“Manufacturers only receive pennies per dose for some of these drugs,” testified Dr. Vimala Raghavendran, senior director of the pharmaceutical supply chain center at US Pharmacopeia. That means there is little financial incentive for multiple manufacturers to make a generic medicine.

Another problem is with the suppliers of the ingredients that make the drugs. Nearly 80% of the manufacturing facilities that produce these active pharmaceutical ingredients are outside the US, the Senate report says. And there is no one agency that keeps track of all these manufacturers, so it is difficult to get a big picture of where the next problem will come from, Raghavendran said.

“Policymakers are flying blind in our understanding of US reliance on other countries for critical ingredients used in the manufacture of medicines,” she said.

Many ingredient makers are based in China or India. If there are work stoppages there, as during the pandemic, it can affect thousands of products.

Consolidation in ingredient manufacturing was a problem even before the pandemic. In 2018, regulators discovered that material created by a Chinese-based company, Zhejiang Huahai Pharmaceutical Co., that went into certain heart drugs was contaminated with a potential cancer-causing impurity. Thousands of drugs had to be recalled in dozens of countries, causing shortages around the world.

In too many cases, the experts said Wednesday, it is not clear why drugs wind up in such short supply. Part of the problem is a lack of transparency about quality results and inspections information. The cause of a specific shortage may be known to regulators, but the information is rarely publicly available.

“FDA sees really clear quality differences between products and manufacturing sites, but this information is confidential, and it’s not available to people making the purchases. Buyers can’t easily see the reliability of manufacturing operations,” Erin Fox, associate chief pharmacy officer at the University of Utah, said at the hearing.

Fox urged the government to develop a rating system for pharmaceutical manufacturing reliability. The FDA has been working on quality metrics ratings, but it doesn’t intend to make the scores publicly available, she said.

Without knowing whether a company is reliable, a health care system can’t always anticipate that a facility is likely to be shut down and create a shortage. A government rating system could help health systems pick more reliable suppliers, Fox said. Because it is so difficult to anticipate what drugs will be in short supply, most health systems must employ someone full-time to exclusively deal with shortage management.

At Michigan, Shuman said, there are multiple pharmacists whose full-time jobs are to manage drug shortages.

“Not every hospital has that resource. Patients should not have better access to scarce drugs based on the hospital they go to,” he said.

Shortages have a direct negative impact on patients and on their providers. Studies show that people often have worse health outcomes when they can’t be treated with the appropriate medication and even, in some cases, when alternative drugs are used.

“One of the challenges of drug shortages is that it requires hospitals to essentially MacGyver different treatment opportunities and regimens, which is not necessarily evidence for data based,” Shuman said.

People with sepsis, for instance, had a higher mortality rate when there was a shortage of the drug norepinephrine.

With shortages of cancer drugs, Shuman described “a tragedy that’s happening in slow motion.”

He cited etoposide, a medicine used to manage a wide variety of cancers, including those of the prostate, bladder, stomach and lung. It’s a low-cost drug at $50 a vial and has been on the market for more than 40 years.

In 2018, when a manufacturing delay caused a national shortage, some doctors had to make terrible choices.

“Which of our patients with cancer should get it? How can we prioritize between American lives? Should our limited vials go to an older woman who was just diagnosed with lung cancer, a young man who’s already been successfully taking it for testicular cancer, or a baby with neuroblastoma and aggressive cancer for which this drug is recommended but others might substitute?” Shuman said. “As a doctor who’s devoted my life to fighting cancer, it’s hard to express how horrible that is.”

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Men with advanced prostate cancer going without life-prolonging medication amid shortage | CNN

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CNN
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Doctors across the United States who treat people with advanced prostate cancer can’t find supplies of a medicine that may help them live longer.

Pluvicto, a drug to treat metastatic castration-resistant prostate cancer, also known as mCRPC, is in such short supply that its maker, Novartis, said it cannot allow further supply to new patients until it can produce more of the drug. The company said it is working to produce enough doses to treat existing patients.

“We recognize that this situation is distressing for patients whether they are currently in the treatment process and being rescheduled, or waiting for their first dose of Pluvicto,” Novartis said in a statement to CNN. “Any interruption in the process, from unplanned manufacturing events to doses not arriving in time, may result in patient doses being rescheduled and can have a cascading effect on patients scheduled for future treatment.”

The Swiss company said it has been in touch with treatment centers and providers in the US and is “actively engaging with them to manage rescheduling of patient doses.”

The problem is that Novartis’ manufacturing facility in Ivrea, Italy, can’t keep up with demand for the drug. In May, it had to suspend production at the facility due to what it said was “an abundance of caution” related to potential quality issues. It also paused production at a New Jersey plant that makes the drug for the Canadian market.

Novartis resumed production at both plants in June.

The company hopes to get the New Jersey plant authorized to produce the drug for the US market, but it’s not clear when that might happen. Novartis said in early March that it had completed its filing for approval from the US Food and Drug Administration.

Someone who has a late-stage cancer that has spread to other parts of the body doesn’t have a lot of time to wait for the company to make more, doctors say, nor do they have many other treatment options. So even if Novartis got approval for the New Jersey plant quickly, the help will come too late for many people, according to Dr. Daniel Spratt, chair of the Department of Radiation Oncology at University Hospitals Seidman Cancer Center in Cleveland.

Novartis said it is prioritizing people who are currently being treated with Pluvicto, which is given in six cycles. But Spratt said the supply has recently been too low even for some of these patients.

“Many patients are missing months of therapy,” he said. “The real tragedy is the patients partially under treatment who have had great responses and we can’t get them the rest of their therapy in a timely fashion.”

Next to skin cancer, prostate cancer is the most common cancer in American men, according to the American Cancer Society. Most men do not die from prostate cancer, but about 34,700 people are expected to die from it this year. It’s the second leading cause of cancer death for American men, behind only lung cancer.

Pluvicto is a targeted radioligand therapy, meaning it uses radioactive atoms to deliver radiation to targeted cells, fighting cancer while limiting damage to the surrounding tissues.

There is no cure for this advanced stage of cancer, but Pluvicto can help people live longer. When the drug got FDA approval in March 2022, Spratt said, there was a lot of excitement about its potential. His patients who had heard about the trials have been asking about it for years.

One study from Novartis’ trials found that people who got the drug lived a median of about 15 months after diagnosis, four months longer than the median for people who didn’t get the treatment. For a handful of people, the recovery is even more dramatic.

“There are some patients that really do have those sort of miraculous responses, so it does occasionally give us one of those ‘wow’ moments,” said Dr. William Dahut, chief scientific officer at the American Cancer Society.

Dahut said doctors also like Pluvicto because, compared with other cancer treatments, it’s easy to administer and has relatively few side effects, other than dry mouth.

Another side effect of the shortage is that it’s slowing the progression of research. There is some indication that the drug could help people before their cancer reaches such a late stage.

“We’re anxious to have greater supply to study it in broader populations,” Dahut said.

Spratt said he is working closely with the medical oncologists in his health care system to try to find alternative treatment options, and he’s been looking to get people into clinical trials so they can get access to the therapy.

“But there’s really very few options available,” he said.

Novartis said that if the FDA approves its plant in Milburn, New Jersey, it could supply more Pluvicto as early as this summer.

The agency told CNN that it “is not able to discuss details regarding any possible communications or actions with companies due to commercial confidential information.”

“To be clear, FDA does not manufacture, produce, bottle, or ship drugs and cannot force companies to do so or make more of a drug. However, in general, the FDA works with firms making drugs in shortage to help them ramp up production if they are willing to do so. Often, they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs.”

Novartis is also building a plant in Indianapolis where the drug will be produced, but that won’t be up and running until the end of the year, the company said.

In the meantime, doctors will often have to tell their patients that they probably won’t be able to help get them this life-extending drug for some time.

“Some men and their physicians will feel that some hope was taken from them,” Spratt siad. “Cancer is the enemy here, not the company, but it’s unfortunate to have that excitement that your physician will be able to prescribe it to you and just not be able to give it to them.”

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Is Guinness really ‘good for you’? | CNN

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CNN
—

Guinness, like other Irish stouts, enjoys a seasonal popularity every St. Patrick’s Day. It has also been touted as being “good for you,” at least by its own advertising posters decades ago.

But can this creamy, rich and filling beer really be added to a list of healthy beverages? Or is its reputation just good marketing? We researched the beer’s history and talked to brewing experts and break out the good, the not-so-great and the ingenuity of Guinness.

The original Guinness is a type of ale known as stout. It’s made from a grist (grain) that includes a large amount of roasted barley, which gives it its intense burnt flavor and very dark color. And though you wouldn’t rank it as healthful as a vegetable, the stouts in general, as well as other beers, may be justified in at least some of their nutritional bragging rights.

According to Charlie Bamforth, distinguished professor emeritus of brewing sciences at the University of California, Davis, most beers contain significant amounts of antioxidants, B vitamins, the mineral silicon (which may help protect against osteoporosis), soluble fiber and prebiotics, which promote the growth of “good” bacteria in your gut.

And Guinness may have a slight edge compared with other brews, even over other stouts.

“We showed that Guinness contained the most folate of the imported beers we analyzed,” Bamforth said. Folate is a B vitamin that our bodies need to make DNA and other genetic material. It’s also necessary for cells to divide. According to his research, stouts on average contain 12.8 micrograms of folate, or 3.2% of the recommended daily allowance.

Because Guinness contains a lot of unmalted barley, which contains more fiber than malted grain, it is also one of the beers with the highest levels of fiber, according to Bamforth. (Note: Though the US Department of Agriculture lists beer as containing zero grams of fiber, Bamforth said his research shows otherwise.)

Bamforth has researched and coauthored studies published in the Journal of the Institute of Brewing and the Journal of the American Society of Brewing Chemists.

Here’s more potentially good news about Guinness: Despite its rich flavor and creamy consistency, it’s not the highest in calories compared with other beers. A 12-ounce serving of Guinness Draught has 125 calories. By comparison, the same size serving of Budweiser has 145 calories, Heineken has 142 calories, and Samuel Adams Cream Stout has 189 calories. In the United States, Guinness Extra Stout, by the way, has 149 calories.

This makes sense when you consider that alcohol is the main source of calories in beers. Guinness Draught has a lower alcohol content, at 4.2% alcohol by volume, compared with 5% for Budweiser and Heineken, and 4.9% for the Samuel Adams Cream Stout.

In general, moderate alcohol consumption – defined by the USDA’s dietary guidelines for Americans as no more than two drinks per day for men or one drink per day for women – may protect against heart disease. So you can check off another box.

Guinness is still alcohol, and consuming too much can impair judgment and contribute to weight gain. Heavy drinking (considered more than 14 drinks a week for men or more than seven drinks a week for women) and binge drinking (five or more drinks for men, and four or more for women, in about a two-hour period) are also associated with many health problems, including liver disease, pancreatitis and high blood pressure.

According to the National Council on Alcoholism and Drug Dependence, “alcohol is the most commonly used addictive substance in the United States: 17.6 million people, or one in every 12 adults, suffer from alcohol abuse or dependence along with several million more who engage in risky, binge drinking patterns that could lead to alcohol problems.”

And while moderate consumption of alcohol may have heart benefits for some, consumption of alcohol can also increase a woman’s risk of breast cancer for each drink consumed daily.

Many decades ago, in Ireland, it would not have been uncommon for a doctor to advise pregnant and nursing women to drink Guinness. But today, experts (particularly in the United States) caution of the dangers associated with consuming any alcohol while pregnant.

“Alcohol is a teratogen, which is something that causes birth defects. It can cause damage to the fetal brain and other organ systems,” said Dr. Erin Tracy, an OB/GYN at Massachusetts General Hospital and Harvard Medical School associate professor of obstetrics, gynecology and reproductive gynecology. “We don’t know of any safe dose of alcohol in pregnancy. Hence we recommend abstaining entirely during this brief period of time in a woman’s life.”

What about beer for breastfeeding? “In Britain, they have it in the culture that drinking Guinness is good for nursing mothers,” said Karl Siebert, professor emeritus of the food science department and previous director of the brewing program at Cornell University.

Beer in general has been regarded as a galactagogue, or stimulant of lactation, for much of history. In fact, according to irishtimes.com, breastfeeding women in Ireland were once given a bottle of Guinness a day in maternity hospitals.

According to Domhnall Marnell, the Guinness ambassador, Guinness Original (also known as Guinness Extra Stout, depending on where it was sold) debuted in 1821, and for a time, it contained live yeast, which had a high iron content, so it was given to anemic individuals or nursing mothers then, before the effects of alcohol were fully understood.

Some studies have showed evidence that ingredients in beer can increase prolactin, a hormone necessary for milk production; others have showed the opposite. Regardless of the conclusions, the alcohol in beer also appears to counter the benefits associated with increased prolactin secretion.

“The problem is that alcohol temporarily inhibits the milk ejection reflex and overall milk supply, especially when ingested in large amounts, and chronic alcohol use lowers milk supply permanently,” said Diana West, coauthor of “The Breastfeeding Mother’s Guide to Making More Milk.”

“Barley can be eaten directly, or even made from commercial barley drinks, which would be less problematic than drinking beer,” West said.

If you’re still not convinced that beer is detrimental to breastfeeding, consider this fact: A nursing mother drinking any type of alcohol puts her baby in potential danger. “The fetal brain is still developing after birth – and since alcohol passes into breast milk, the baby is still at risk,” Tracy said.

“This is something we would not advocate today,” Marnell agreed. “We would not recommend to anyone who is pregnant or breastfeeding to be enjoying our products during this time in their life.”

Regarding the old wives’ tale about beer’s effects on breastfeeding, Marnell added, “It’s not something that Guinness has perpetuated … and if (people are still saying it), I’d like to say once and for all, it’s not something we support or recommend.”

Assuming you are healthy and have the green light to drink beer, you might wonder why Guinness feels like you’ve consumed a meal, despite its lower calorie and alcohol content.

It has to do with the sophistication that goes into producing and pouring Guinness. According to Bamforth, for more than half a century, Guinness has put nitrogen gas into its beer at the packaging stage, which gives smaller, more stable bubbles and delivers a more luscious mouthfeel. It also tempers the harsh burnt character coming from the roasted barley. Guinness cans, containing a widget to control the pour, also have some nitrogen.

Guinness is also dispensed through a special tap that uses a mixture of carbon dioxide and nitrogen. “In Ireland, Guinness had a long history of hiring the best and brightest university graduates regardless of what they were trained in,” Siebert said. “And they put them to work on things they needed. One was a special tap for dispensing Guinness, which has 11 different nozzles in it, that helps to form the fine-bubbled foam.”

The foam is remarkably long-lasting. “After you get a freshly poured Guinness, you can make a face in the foam, and by the time you finish drinking it, the face is still there,” Siebert said.

The famous advertising Guinness slogans – including “It’s a good day for a Guinness” – started through word of mouth, said Marnell. “In 1929, when we were about to do our first ad, we asked (ourselves), ‘What stance should we take?’ So we sent around a group of marketers (in Ireland and the UK) to ask Guinness drinkers why they chose Guinness, and nine out of 10 said their belief was that the beer was healthy for them. We already had this reputation in the bars before we uttered a word about the beer.

“That led to the Gilroy ads that were posted,” Marnell explained, referring to the artist John Gilroy, responsible for the Guinness ads from 1928 to the 1960s. “You’ll see the characters representing the Guinness brand – the toucan, the pelican – and slogans like ‘Guinness is good for you’ or ‘Guinness for Strength.’ But those were from the 1920s, ’30s and ‘40s.”

Today, he said, the company would not claim any health benefits for its beer. “If anyone is under the impression that there are health benefits to drinking Guinness, then unfortunately, I’m the bearer of bad news. Guinness is not going to build muscle or cure you of influenza.”

In fact, Guinness’ parent company, Diageo, spends a lot of effort supporting responsible drinking initiatives and educating consumers about alcohol’s effects. Its DrinkIQ page offers information such as calories in alcohol, how your body processes it and when alcohol can be dangerous, including during pregnancy.

“One of the main things we focus on … is that while we would love people to enjoy our beer, we want to make sure they do so as responsibly as possible,” Marnell said. “We would never recommend that anyone drink to excess, and (we want to make people) aware of how alcohol effects the body.”

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And again: Most health providers in the US would advise forgoing all alcohol if you are pregnant, nursing or have other health or medical issues where alcohol consumption is not advised.

So responsibly celebrate St. Patrick this year a little wiser about the health benefits and risks with one of its signature potables.

This story originally published in 2017.

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

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KHN
—

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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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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Naloxone nasal spray may soon be in your pharmacy. Our medical analyst explains what it is and who can use it | CNN

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CNN
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Two advisory committees to the US Food and Drug Administration have voted unanimously to recommend that a nasal spray version of the opioid overdose antidote, naloxone (also called Narcan), be made available over the counter.

If the FDA agrees with this recommendation, naloxone may soon be sold without a prescription in pharmacies and made available in grocery stores, big-box stores, gas stations, and corner stores around the country.

This development comes at a time when opioid overdoses are at a record high, rising more than 15% in one year. Deaths attributed to opioids rose from around 70,000 in 2020 to 80,800 in 2021, according to the US Centers for Disease Control and Prevention. The highly potent and lethal opioid, fentanyl, is implicated in the majority of these deaths.

What is naloxone, and how does it work to save lives from opioid overdose? How do you know if someone is overdosing, and how can bystanders administer the antidote? How can people get access to it now, and what will it mean if the FDA approves it for over-the-counter use? What more needs to be done to reduce overdose deaths?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she was Baltimore’s health commissioner, where she led the city’s overdose prevention strategy.

CNN: How does naloxone work to save people overdosing on opioids?

Dr. Leana Wen: Naloxone is a medicine that rapidly reverses the effect of an opioid overdose. It is an antagonist to opioids, meaning that it attaches to the opioid receptors in the brain, and in doing so, reverses and blocks the effects of opioids.

Someone who has taken too large of a quantity of opioids can become unconscious and stop breathing. This is deadly — a person can die within minutes after they stop breathing. Naloxone reverses the effect of the opioid overdose and can restore normal breathing within a couple of minutes.

CNN: What are the different versions of naloxone? Does it work against illicit drugs like heroin and fentanyl as well as prescription drugs?

Wen: Naloxone comes in two main forms. There is the nasal spray version, with one manufacturer calling its product Narcan Nasal Spray. This version is sprayed into the nostril, similar to some allergy medications.

Naloxone also comes as a liquid. This form can be injected either intravenously through an IV, if a patient already has an IV inserted, or intramuscularly, usually as a shot through the quadriceps muscle in the leg.

Several years ago, there was another version of naloxone that was in an autoinjector, similar to an EpiPen that’s given to people with life-threatening allergic reactions. In 2019, the manufacturer made a business decision to stop making that version available to the public. (An autoinjector is still approved for use by the military and for chemical incident responders.)

The nasal spray, intravenous and intramuscular versions all work very well, and they all work against various versions of opioids. That includes not only heroin and fentanyl but also common opioid medications like oxycodone, hydrocodone, codeine and morphine. It’s important to note that one dose may not be enough, depending on how potent and how much opioid was taken. Often, several doses are needed to revive someone.

CNN: How do you know if someone is overdosing, and how can bystanders administer the antidote?

Wen: Signs of overdose include being unable to be awakened, breathing slowly or not breathing at all, and fingernails and lips taking on a blue or purple color while the skin becomes pale and clammy to the touch. Their pupils are often described as “pinpoint,” or very small.

Someone can overdose from taking too much of an opioid by accident. This often happens when fentanyl, an extremely potent opioid, is mixed with whatever the person is taking without their knowledge. Also, if an opioid is mixed with alcohol or benzodiazepines or other opioids, they can also become unresponsive. And there are instances when someone may not realize they are taking opioids, but the pill they obtained is contaminated with fentanyl.

If someone is overdosing, you or someone who is with you must call 911 immediately. In the meantime, administer naloxone. Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important for the person to receive medical attention after receiving the drug. Depending on the opioid the person took, they may need to be monitored in the hospital for hours after in case naloxone wears off while the opioid continues to have an effect.

If you have the nasal spray version, insert the tip of the device into the nostril and squeeze. Another spray may be given in the other nostril in two to three minutes if the patient remains unresponsive, and another one in another two to three minutes until either the patient responds or emergency help arrives. If you are trained to perform CPR, and the person isn’t breathing, you should administer CPR as well, in between giving naloxone.

CNN: Is naloxone safe to use? What if you’re not sure if someone is overdosing from opioids?

Wen: Yes, naloxone is extremely safe. If someone is not on opioids and is unresponsive, say, because they drank too much alcohol or has had a stroke, naloxone will have no adverse effect for them. That’s why emergency medical personnel routinely administer naloxone to patients who are found to be unresponsive; there is no harm to people who are unresponsive from non-opioid-related reasons.

If someone overdosed on opioids, naloxone reversal will send them into withdrawal. This could be unpleasant for the individual and could lead to vomiting, agitation, shivering, tearing up and having a runny nose. These aren’t desirable side effects, of course, but in cases when naloxone must be given, the alternative is death.

CNN: How can people get access to naloxone now? What will it mean if the FDA approves it for over-the-counter use?

Wen: As an emergency physician, I’ve given naloxone many times. First responders like paramedics and emergency medical technicians also routinely administer naloxone. When I served as Baltimore’s health commissioner, I felt strongly that everyone should be able to save someone else’s life.

Nonmedical personnel may already obtain and carry naloxone with them, but specific requirements and regulations vary by the state. Health departments and some community nonprofit groups have low-priced or free naloxone that they distribute to community members. Often, the naloxone is distributed to individuals who use drugs, because they are most likely to be around others who are overdosing. Also, their family members can use naloxone to revive them.

If the FDA approves the nasal spray naloxone for over-the-counter use, that means it will be more accessible. People should be able to purchase the spray from pharmacies, grocery stores, gas stations and perhaps even vending machines.

The problem is cost. We don’t yet know how the over-the-counter naloxone spray will be priced, and whether and how much insurance companies cover it will probably vary.

CNN: What more needs to be done to reduce overdose deaths?

Wen: Naloxone access is an important step. Someone who is overdosing has no chance for a better tomorrow if they are dead today. I would encourage everyone with a family member who is on opioids for chronic pain or has an opioid addiction to carry naloxone with them, so that they could save their loved one’s life.

Longer-term, a person who has an opioid use disorder needs treatment with a combination of medications and psychosocial supports. Much more needs to be done to expand treatment access, as well as to reduce the supply of illicitly manufactured drugs like fentanyl that are worsening the overdose crisis.

Finally, I want to remind everyone of 988, a new 24/7 phone and chat hotline that provides suicide counseling, crisis supports and referral for people in need of mental health and addiction support.

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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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