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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
—

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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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
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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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US maternal death rate rose sharply in 2021, CDC data shows, and experts worry the problem is getting worse | CNN

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CNN
—

As women continue to die due to pregnancy or childbirth each year in the United States, new federal data shows that the nation’s maternal death rate rose significantly yet again in 2021, with the rates among Black women more than twice as high as those of White women.

Experts said the United States’ ongoing maternal mortality crisis was compounded by Covid-19, which led to a “dramatic” increase in deaths.

The number of women who died of maternal causes in the United States rose to 1,205 in 2021, according to a report from the National Center for Health Statistics, released Thursday by the US Centers for Disease Control and Prevention. That’s a sharp increase from years earlier: 658 in 2018, 754 in 2019 and 861 in 2020.

That means the US maternal death rate for 2021 – the year for which the most recent data is available – was 32.9 deaths per 100,000 live births, compared with rates of 20.1 in 2019 and 23.8 in 2020.

The new report also notes significant racial disparities in the nation’s maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is 2.6 times the rate for White women, at 26.6 per 100,000.

The data showed that rates increased with the mother’s age. In 2021, the maternal death rate was 20.4 deaths per 100,000 live births for women under 25 and 31.3 for those 25 to 39, but it was 138.5 for those 40 and older. That means the rate for women 40 and older was 6.8 times higher than the rate for women under age 25, according to the report.

The maternal death rate in the United States has been steadily climbing over the past three decades, and these increases continued through the Covid-19 pandemic.

Questions remain about how the pandemic may have affected maternal mortality in the United States, according to Dr. Elizabeth Cherot, chief medical and health officer for the infant and maternal health nonprofit March of Dimes, who was not involved in the new report.

“What happened in 2020 and 2021 compared with 2019 is Covid,” Cherot said. “This is sort of my reflection on this time period, Covid-19 and pregnancy. Women were at increased risk for morbidity and mortality from Covid. And that actually has been well-proven in some studies, showing increased risks of death, but also being ventilated in the intensive care unit, preeclampsia and blood clots, all of those things increasing a risk of morbidity and mortality.”

The American College of Obstetricians and Gynecologists previously expressed “great concern” that the pandemic would worsen the US maternal mortality crisis, ACOG President Dr. Iffath Abbasi Hoskins said in a statement Thursday.

“Provisional data released in late 2022 in a U.S. Government Accountability Office report indicated that maternal death rates in 2021 had spiked—in large part due to COVID-19. Still, confirmation of a roughly 40% increase in preventable deaths compared to a year prior is stunning new,” Hoskins said.

“The new data from the NCHS also show a nearly 60% percent increase in maternal mortality rates in 2021 from 2019, just before the start of the pandemic. The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was—and still is—already a maternal mortality crisis to compound.”

Health officials stress that people who are pregnant should get vaccinated against Covid-19 and that doing so offers protection for both the mother and the baby.

During the early days of the pandemic, in 2020, there was limited information about the vaccine’s risks and benefits during pregnancy, prompting some women to hold off on getting vaccinated. But now, there is mounting evidence of the importance of getting vaccinated for protection against serious illness and the risks of Covid-19 during pregnancy.

The Covid-19 pandemic also may have exacerbated existing racial disparities in the maternal death rate among Black women compared with White women, said Dr. Chasity Jennings-Nuñez, a California-based site director with Ob Hospitalist Group and chair of the perinatal/gynecology department at Adventist Health-Glendale, who was not involved in the new report.

“In terms of maternal mortality, it continues to highlight those structural and systemic problems that we saw so clearly during the Covid-19 pandemic,” Jennings-Nuñez said.

“So in terms of issues of racial health inequities, of structural racism and bias, of access to health care, all of those factors that we know have played a role in terms of maternal mortality in the past continue to play a role in maternal mortality,” she said. “Until we begin to address those issues, even without a pandemic, we’re going to continue to see numbers go in the wrong direction.”

Some policies have been introduced to tackle the United States’ maternal health crisis, including the Black Maternal “Momnibus” Act of 2021, a sweeping bipartisan package of bills that aim to provide pre- and post-natal support for Black mothers, including extending eligibility for certain benefits postpartum.

As part of the Momnibus, President Biden signed the bipartisan Protecting Moms Who Served Act in 2021, and other provisions have passed in the House.

In the United States, about 6.9 million women have little or no access to maternal health care, according to March of Dimes, which has been advocating in support of the Momnibus.

The US has the highest maternal death rate of any developed nation, according to the Commonwealth Fund and the latest data from the World Health Organization. While maternal death rates have been either stable or rising across the United States, they are declining in most countries.

“A high rate of cesarean sections, inadequate prenatal care, and elevated rates of chronic illnesses like obesity, diabetes, and heart disease may be factors contributing to the high U.S. maternal mortality rate. Many maternal deaths result from missed or delayed opportunities for treatment,” researchers from the Commonwealth Fund wrote in a report last year.

The ongoing rise in maternal deaths in the United States is “disappointing,” said Dr. Elizabeth Langen, a high-risk maternal-fetal medicine physician at the University of Michigan Health Von Voigtlander Women’s Hospital. She was not involved in the latest report but cares for people who have had serious complications during pregnancy or childbirth.

“Those of us who work in the maternity care space have known that this is a problem in our country for quite a long time. And each time the new statistics come out, we’re hopeful that some of the efforts that have been going on are going to shift the direction of this trend. It’s really disappointing to see that the trend is not going in the right direction but, at some level, is going in the worst direction and at a little bit of a faster rate,” Langen said.

“In the health care system, we need to accept ultimate responsibility for the women who die in our care,” she added. “But as a nation, we also need to accept some responsibility. We need to think about: How do we provide appropriate maternity care for people? How do we let people have time off of work to see their midwife or physician so that they get the care that they need? How do all of us make it possible to live a healthy life while you’re pregnant so that you have the opportunity to have the best possible outcome?”

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How to reduce PFAS in your drinking water, according to experts | CNN

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CNN
—

In the next three years, drinking water in the United States may be a bit safer from potentially toxic chemicals that have been detected in the blood of 98% of Americans.

Perfluoroalkyl and polyfluoroalkyl substances or PFAS are a family of thousands of man-made chemicals that do not break down easily in the environment. A number of PFAS have been linked to serious health problems, including cancer, fertility issues, high cholesterol, hormone disruption, liver damage, obesity and thyroid disease.

The US Environmental Protection Agency proposed on Tuesday stringent new limits on levels of six PFAS chemicals in public water systems. Under the proposed rule, public systems that provide water to at least 15 service connections or 25 people will have three years to implement testing procedures, begin notifying the public about PFAS levels, and reduce levels if above the new standard, the EPA said.

Two of the most well-studied and potentially toxic chemicals, PFOA and PFOS, cannot exceed 4 parts per trillion in drinking water, compared with a previous health advisory of 70 parts per trillion, the EPA said.

Another four chemicals — PFNA, PFHxS, PFBS and GenX — will be subject to a hazard index calculation to determine whether the levels of these PFAS pose a potential risk. The calculation is “a tool the EPA uses to address the cumulative risks from all four of those chemicals,” said Melanie Benesh, vice president of government affairs for the Environmental Working Group, a consumer organization that monitors exposure to PFAS and other chemicals.

“The EPA action is a really important and historic step forward,” Benesh said. “While the proposed regulations only address a few PFAS, they are important marker chemicals. I think requiring water systems to test and treat for these six will actually do a lot to address other PFAS that are in the water as well.”

For people who are concerned about PFAS exposure, three years or so is a long time. What can consumers do now to limit the levels of PFAS in their drinking water?

First, look up levels of PFAS in your local public water system, suggested David Andrews, a senior scientist at the Environmental Working Group. The advocacy nonprofit has created a national tap water database searchable by zip code that lists PFAS and other concerning chemicals, as well as a national map that illustrates where PFAS has been detected in the US.

However, not all water utilities currently test for pollutants, and many rural residents rely on wells for water. Anyone who wants to personally test their water can purchase a test online or from a certified lab, Andrews said.

“The most important thing is to ensure the testing method can detect down to at least four parts per trillion or lower of PFAS,” he said. “There are a large number of labs across the country certified to test to that level, so there are a lot of options available.”

If levels are concerning, consumers can purchase a water filter for their tap. NSF, formerly the National Sanitation Foundation, has a list of recommended filters.

“The water filters that are most effective for PFAS are reverse osmosis filters, which are more expensive, about in the $200 range,” Andrews said. Reverse osmosis filters can remove a wide range of contaminants, including dissolved solids, by forcing water through various filters.

“Granular activated carbon filters are more common and less expensive but not quite as effective or consistent for PFAS,” he said, “although they too can remove a large number of other contaminants.”

Reverse osmosis systems use both carbon-based filters and reverse osmosis membranes, Andrews explained. Water passes through the carbon filter before entering the membrane.

“The important part is that you have to keep changing those filters,” he said. “If you don’t change that filter, and it becomes saturated, the levels of PFAS in the filtered water can actually be above the levels in the tap water.”

Carbon filters are typically replaced every six months, “while the reverse osmosis filter is replaced on a five-year time frame,” he added. “The cost is relatively comparable over their lifetime.”

Another positive: Many of the filters that work for PFAS also filter other contaminants in water, Andrews said.

Drinking water is not the only way PFAS enters the bloodstream. Thousands of varieties of PFAS are used in many of the products we purchase, including nonstick cookware, infection-resistant surgical gowns and drapes, mobile phones, semiconductors, commercial aircraft, and low-emissions vehicles.

The chemicals are also used to make carpeting, clothing, furniture, and food packaging resistant to stains, water and grease damage. Once treated, the report said, textiles emit PFAS over the course of their lifetimes, escaping into the air and groundwater in homes and communities.

Made from a chain of linked carbon and fluorine atoms that do not readily degrade in the environment, PFAS are known as “forever chemicals.” Due to their long half life in the human body, it can take some PFAS years to completely leave the body, according to a 2022 report by the prestigious National Academies of Sciences, Engineering, and Medicine.

“Some of these chemicals have half-lives in the range of five years,” National Academies committee member Jane Hoppin, an environmental epidemiologist and director of the Center for Human Health and the Environment at North Carolina State University in Raleigh, told CNN previously.

“Let’s say you have 10 nanograms of PFAS in your body right now. Even with no additional exposure, five years from now you would still have 5 nanograms.

“Five years later, you would have 2.5 and then five years after that, you’d have one 1.25 nanograms,” she continued. “It would be about 25 years before all the PFAS leave your body.”

The 2022 National Academies report set “nanogram” levels of concern and encouraged clinicians to conduct blood tests on patients who are worried about exposure or who are at high risk. (A nanogram is equivalent to one-billionth of a gram.)

People in “vulnerable life stages” — such as during fetal development in pregnancy, early childhood and old age — are at high risk, the report said. So are firefighters, workers in fluorochemical manufacturing plants, and those who live near commercial airports, military bases, landfills, incinerators, wastewater treatment plants and farms where contaminated sewage sludge is used.

The PFAS-REACH (Research, Education, and Action for Community Health) project, funded by the National Institute of Environmental Health Sciences, gives the following advice on how to avoid PFAS at home and in products:

Stay away from stain-resistant carpets and upholstery, and don’t use waterproofing sprays.
Look for the ingredient polytetrafluoroethylene, or PTFE, or other “fluoro” ingredients on product labels.
Avoid nonstick cookware. Instead use cast-iron, stainless steel, glass or enamel products.
Boycott takeout containers and other food packaging. Instead cook at home and eat more fresh foods.
Don’t eat microwave popcorn or greasy foods wrapped in paper.
Choose uncoated nylon or silk dental floss or one that is coated in natural wax.

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What is the painful condition called shingles? | CNN

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CNN
—

Sen. Dianne Feinstein, the 89-year-old California Democrat, recently announced she is out of the hospital and recovering at home from shingles, a painful viral inflammation in the skin’s nerves that causes a blistering rash lasting for two to four weeks. Feinstein was diagnosed in February and hospitalized in San Francisco last week.

Shingles, also called herpes zoster, is caused by the varicella-zoster virus — which is the same virus responsible for chickenpox. Varicella zoster is also responsible for a rare condition called Ramsay Hunt syndrome that caused pop star Justin Bieber’s face to become partially paralyzed in June 2022.

“As you can see, this eye is not blinking. I can’t smile on this side of my face. This nostril will not move,” Bieber said at the time in answer to fans who wondered why he had canceled performances.

Painful skin is one of first signs of shingles, and for some people, the pain is intense. It can create a burning sensation, or the skin can tingle or be sensitive to touch, according to the Mayo Clinic. Shingles can occur at other places on the body, such as the face and scalp, but the most common presentation is on the torso on one side of the body.

A red rash will begin to develop at the site of the pain within a few days. The rash often begins as a small, painful patch, which then spreads like “a stripe of blisters that wraps around either the left or right side of the torso,” the Mayo Clinic said.

In rare cases, the rash may become more widespread and look similar to a chickenpox rash, typically in people with weakened immune systems, according to the US Centers of Disease Control and Prevention.

In addition to pain, some people may develop chills, fatigue, fever, headache, upset stomach and sensitivity to light. See a doctor if you are over 50, have a weakened immune system, the rash is widespread and painful, or the pain and rash occur near an eye.

“If left untreated, this infection may lead to permanent eye damage,” according to the Mayo Clinic.

The varicella-zoster virus is highly contagious when in the blister stage, spreading through direct contact with the fluid from blisters and via viral particles in the air.

However, you cannot get shingles from someone who has shingles. If you aren’t vaccinated for chickenpox or haven’t previously had it and are infected by that person, you will develop chickenpox, which then puts you at risk for shingles later in life, the CDC said.

If you have shingles, you can prevent the spread of the virus by covering the rash and not touching or scratching the raised vesicles that form the rash, the CDC stated. Wash your hands often.

“People with shingles cannot spread the virus before their rash blisters appear or after the rash crusts,” the CDC said.

If the rash is covered, the risk of transmission “is low,” the CDC said. “People with chickenpox are more likely to spread (the virus) than people with shingles.”

If you think you have shingles, call a doctor as soon as you can, the CDC recommended. If caught early, there are antiviral medications, including acyclovir, valacyclovir and famciclovir, that can shorten the length and severity of the illness.

“These medicines are most effective if you start taking them as soon as possible after the rash appears,” the CDC said.

Doctors may also suggest over-the-counter or prescription pain medication for the burning and pain, while calamine lotion, wet compresses and oatmeal baths may ease itching.

For older adults, the population most likely to develop shingles, the best treatment is prevention. The US Food and Drug Administration approved a two-dose vaccine called Shingrix in 2017 for people 50 and older.

“Shingrix is also recommended for adults 19 years and older who have weakened immune systems because of disease or therapy,” the CDC said.

Shingrix, which is not based on a live virus, is more than 90% effective in encouraging the aging immune system to recognize and be ready to fight the virus, according to its manufacturer, GlaxoSmithKline.

Anyone who has had a severe allergic reaction to a dose of Shingrix or is allergic to any of the components of the vaccine should avoid it, the CDC said.

“People who currently have shingles, and women who are pregnant or breastfeeding, should wait to get Shingrix,” the CDC said.

Another vaccine called Zostavax, which the FDA approved for people over 50 in 2006, is 51% effective in preventing shingles, according to the CDC. Zostavax is based on a live virus, the same approach used for the chickenpox vaccine recommended in childhood. It has not been sold in the United States since November 2020.

If you have never had chickenpox, you can’t get shingles. However, once you’ve had chickenpox, the virus remains inactive in the spine’s sensory neurons, possibly erupting years later as shingles.

Two doses of a chickenpox vaccine for children, teens and adults, introduced in 1995, is 100% effective at preventing a severe case of chickenpox, according to the CDC. Immunity lasts 10 to 20 years, the CDC noted.

In the small number of people who still get chickenpox after vaccination, the illness is typically milder, with few or no blisters.

The CDC recommends the vaccine be given to children in two doses, the first between 12 and 15 months and a second one between 4 and 6 years. Anyone 13 years old and older who has no evidence of immunity can get two doses four to eight weeks apart, the CDC said.

Some people should not get the vaccine, including pregnant women, people with certain blood disorders or those on prolonged immunosuppressive therapy, and those with a moderate or severe illness, among others.

About 1 in 10 people will develop a painful and possibly debilitating condition called postherpetic neuralgia, or long-term nerve pain. All other signs of the rash can be gone, but the area is extremely painful to touch. Less often, itching or numbness can occur.

The condition rarely affects people under 40, the CDC said. Older adults are most likely to have more severe pain that lasts longer than a younger person with shingles. For some, the nerve pain can be devastating.

“Five years later, I still take prescription medication for pain,” said a 63-year-old harpist who shared his story on the CDC website. “My shingles rash quickly developed into open, oozing sores that in only a few days required me to be hospitalized.

“I could not eat, sleep, or perform even the most minor tasks. It was totally debilitating. The pain still limits my activity levels to this day,” said the musician, who has been unable to continue playing the harp due to pain.

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Up to 20,000 people who attended a religious gathering may have been exposed to measles. What should they do next? | CNN

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CNN
—

Up to 20,000 people who attended a religious gathering at a college in Wilmore, Kentucky, in February could have been exposed to a person later diagnosed with measles.

On Friday, the US Centers for Disease Control and Prevention issued an alert to clinicians and public health officials about the confirmed case of measles in an individual present at the gathering who had not been vaccinated against the disease.

“If you attended the Asbury University gathering on February 17 or 18 and you are unvaccinated or not fully vaccinated against measles, you should quarantine for 21 days after your last exposure and monitor yourself for symptoms of measles so that you do not spread measles to others,” according to the CDC advisory.

The CDC also recommended that people who are unvaccinated receive the measles, mumps, and rubella (MMR) vaccine.

Reading this news, people may have questions about measles, including its symptoms, infection outcomes and who is most at risk. They may also want to know what makes measles so contagious, what has been the cause of recent outbreaks and how effective the MMR vaccine is.

To help answer 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. Previously, she served as Baltimore’s health commissioner, where her duties included overseeing the city’s immunization and infectious disease investigations.

CNN: What is measles, and what are the symptoms?

Dr. Leana Wen: Measles is an extremely contagious illness that’s caused by the measles virus. Despite many public health advances, including the development of the MMR vaccine, it remains a major cause of death among children globally.

The measles virus is transmitted via droplets from the nose, mouth or throat of infected individuals. If someone is infected and coughs or sneezes, droplets can land on you and infect you. These droplets can land on surfaces, and if you touch the surface and then touch your nose or mouth, that could infect you, too.

Symptoms usually appear 10 to 12 days after infection. They include a high fever, runny nose, conjunctivitis (pink eye) and small, painless white spots on the inside of the mouth. A few days after these symptoms begin, many individuals develop a characteristic rash — flat red spots that generally start on the face and then spread downward over the neck, trunk, arms, legs and feet. The spots can become joined together as they spread and can be accompanied by a high fever.

A nurse gives a woman a measles, mumps and rubella virus vaccin at the Utah County Health Department on April 29, 2019 in Provo, Utah.

CNN: What are outcomes of measles infections? Who is most at risk?

Wen: Many individuals recover without incident. Others, however, can develop severe complications.

One in five unvaccinated people with measles are hospitalized, according to the CDC. As many as 1 out of every 20 children with measles will get pneumonia; about 1 in 1,000 who get measles can develop encephalitis, a swelling of the brain that can lead to seizures and leave the child with lasting disabilities. And nearly 1 to 3 out of every 1,000 children who are infected with measles will die.

Measles is not only a concern for children. It can also cause premature births in pregnant women who contract it. Immunocompromised people, such as cancer patients and those infected with HIV, are also at increased risk.

CNN: What makes measles so contagious?

Wen: Measles is one of the most contagious diseases in the world — up to 90% of the unvaccinated people who come into contact with a contagious individual will also become infected. The measles virus can remain in the air for up to two hours after an infected person leaves an area.

Another reason why measles spreads so easily is its long incubation period. In infected people, the time from exposure to fever is an average of about 10 days, and from exposure to rash onset is about 14 days — but could be up to 21 days. In addition, infected people are contagious from four days before rash starts through four days after. That’s a long period of time where they could unknowingly infect others.

CNN: What has been the cause of recent measles outbreaks?

Wen: It’s important to note that this incident in Kentucky is not yet considered an outbreak. Only one person has been diagnosed with measles. That person was possibly exposed to many others given the number of people in attendance at this gathering, but we don’t know yet if any of those people were infected.

But let’s look at a recent example of a confirmed outbreak in the US: In November 2022, health officials in central Ohio raised alarm over young children being diagnosed with measles. In all, 85 children got sick. None of the children died, but 36 needed to be hospitalized. All those infected were either unvaccinated or not yet fully vaccinated.

Health officials were able to contain the outbreak through contact tracing, vaccination and other public health measures in early February, and it was declared over. But there is concern it won’t be the last of its kind. A study from the CDC reported the rate of immunizations for required vaccines among kindergarten students nationwide dropped from 95% in the 2019-20 school year to 93% in the 2021-22 school year. Some communities have far lower rates than this national average, however, which can lead to outbreaks — not only of measles but also diseases like polio that can also have severe consequences.

CNN: How effective is the MMR vaccine?

Wen: The MMR vaccine is a two-dose vaccine. The recommendation is for children to receive the first dose at age 12-15 months and the second dose at age 4-6 years. One dose of the MMR vaccine 93% effective at preventing measles infection. Two doses are 97% effective.

CNN: What is the best way to protect against measles?

Wen: The MMR vaccine is an extremely safe and very effective vaccine and is recognized as a significant public health advance for preventing an otherwise extremely contagious disease from spreading and causing potentially very severe — even fatal — outcomes.

Consider that the vaccine was licensed in the US in 1963. In the four years before that, there were an average of more than 500,000 cases of measles every year and over 430 measles-associated deaths. By 1998, there were just 89 cases and no measles-associated deaths. That’s a huge public health triumph.

Young children should receive the vaccine according to the recommended schedule. Older kids and adults who never received it should also discuss getting it with their health care provider. And clinicians and public health officials in the US and around the world should redouble efforts to increase routine childhood immunizations so as to stop preventable diseases from making a comeback.

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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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