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



CNN
 — 

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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One month later, people living near a toxic train derailment wonder if their lives will ever be back on track | CNN


East Palestine, Ohio
CNN
 — 

This had been a quiet little town of about 4,700 people nestled in the rolling hills of Northeast Ohio. A sign posted on State Road 14 welcomes visitors to East Palestine, “the place to be.”

But for the past month, ever since a freight train derailed and caught fire, the town has been bustling with responders and reporters. Residents say they’re grateful for the help, but the attention and uncertainty have begun to strain the town’s hospitality.

Town halls and news conferences have taken over the school auditoriums and municipal buildings and shut down its main street. A clinic opened to address worrisome health questions and symptoms, and government workers have been going door-to-door to survey residents about health impacts.

Gov. Mike DeWine has traveled to East Palestine four times since the derailment and US Environmental Protection Agency Administrator Michael Regan three times, each with entourages of aides and press wranglers. Some business owners near the downtown area are so tired of answering questions, they posted signs asking reporters to stay out.

The streets are busy with utility trucks for environmental clean-up companies TetraTech, Arcadis and AEComm. Plastic hoses snake into Leslie Run and Sulphur Run, two creeks that run through town that were contaminated by the accident. Large pieces of equipment that look like showerheads churn and bubble the water in these streams, hoping to speed the breakdown of chemicals in them.

Still, the floral, fruity odor of the chemical butyl acrylate still wafts up from the streams.

Many residents say they are angry.

Donna Reidy, 62, lives about a mile and a half away from the site in a white house on a hill that overlooks Leslie Run, one of the area waterways contaminated by the spill. On Thursday, she answered questions for a government health study that’s being conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention.

Reidy said that neither she or her husband – who has lung problems and requires supplemental oxygen – experienced any new or worsening physical symptoms since the derailment. However, her daughter, who also lives in East Palestine, had, she told investigators.

Reidy said her daughter had to gone to the hospital after vomiting and developing a rash. Donna said the stress of trying to protect her husband and worry for her daughter had worsened some anxiety she already struggled with, and she’s afraid of health problems that could arise later on.

“I’ve already had cancer, I don’t want to get it again,” she told Dr. Dallas Shi, an officer in the CDC’s Epidemic Intelligence Service, as they stood in the front yard outside her home.

For the study, called an assessment of chemical exposure, or ACE, Shi is working with a mapping specialist Ian Dunn, a geospatial health scientist and CDC contractor, to interview residents in some of the areas believed to be most impacted by the contamination.

After Reidy answered pages of required questions, Shi and Dunn ask her if there was anything else she wanted them to know.

“Yeah,” she said. “This stuff sucks.”

“We got roots here,” she told them. Five generations of her family lived in East Palestine. Her husband’s father saved money during World War II and sent it home to his wife so they could buy the home they live in today. Her children and grandchildren have gone to the local schools.

“They just ruined everything,” Reidy says, speaking of Norfolk Southern.

“My kids are moving, my grandkids are moving away. They just ruined everything,” she said as she started to cry.

“I’m so sorry,” Shi said, “Can I give you a hug?”

Shi, who was dressed in her dark blue public health service uniform and black work boots, put her arms around Reidy. “I can’t imagine,” she said.

“I’m so mad at them because they’re so cheap and all they cared about was money for themselves,” Reidy went on, speaking through tears. “They should have huge fines against them.”

Then Reidy apologized for getting upset.

On Thursday night, some area residents came to the local high school auditorium for a town hall meeting – their first chance to confront Norfolk Southern since the spill – and expressed similar anger and frustration.

The company was ordered to appear at the town hall by the EPA after declining to participate in earlier events.

“One thing I would like to say … is that we are sorry. We’re very sorry. We feel horrible about it,” said Darrell Wilson, who was representing the company.

The room erupted with shouts of “Buy us out!”

“Do the right thing,” one man shouted. “Tell Alan to buy us out,” referring to Norfolk Southern CEO Alan Shaw.

Several people said they believed staying in their homes was making them ill, but they couldn’t afford to go anywhere else. They want the railroad to buy their homes, which they feel have lost value since the spill.

“Get us out!” some yelled.

“We are going to do the right thing,” Wilson said, responding to the shouts.

Wilson said the company had leased office space in town and “and we signed a long lease. So we’re gonna be here for a long time,” he said..

But when asked whether there had been talk of the company relocating residents, he said there had not.

Some said they had experienced health problems since returning to their homes after the derailment. Others said they had lost their jobs or stopped going to work at jobs they felt were too close to the site. They are worried about their children or grandchildren potentially being exposed to toxins and having health problems down the road.

Some people say they continue to experience symptoms such as headaches, vomiting, dizziness and persistent coughs, and they feel puzzled by ongoing tests of the town’s air and water that have not detected chemicals at levels that are known to pose health risks.

“Why are people getting sick if there are no toxins?” East Palestine resident Jamie Cozza asked the panel answering questions at Thursday’s town hall.

“We do have a team here that is trying to collect health information so that we have a better understanding of the potential exposures and health effects,” said Capt. Jill Shugart, who is an associate director of emergency management at CDC’s Agency for Toxic Substances and Disease Registry, or ATSDR.

The agency is conducting a total of three Assessment of Chemical Exposure, or ACE, investigations – one for Ohio residents, one for people in Pennsylvania, and another for first responders to the accident scene.

Shugart said it would take about three weeks to collect enough information to get an understanding of the full picture, then the agency has to work with Pennsylvania and Ohio to present their findings to residents.

Data from some surveys are starting to come available. On Friday, the Ohio Department of Health released preliminary data from its ACE survey, and out of 168 completed, 74% of people said they experienced headaches, 64% reported anxiety, 61% reported coughing, 58% listed fatigue, and 52% said they had irritation, pain or burning of their skin. The health department is still collecting surveys through its health assessment clinic, which will be open again next week.

Many at the town hall said they felt that the evacuation order had been lifted too soon – less than a week after the derailment – and may have put them in harm’s way, before any potential dangers were fully assessed.

On Thursday, the EPA capitulated to demands from residents and said it would require Norfolk Southern to test for dioxins, cancer-causing chemicals that form during combustion. The EPA had previously declined to require testing for dioxins, saying that these chemicals are already present in the environment, so it’s hard to interpret what their levels mean. The EPA said it would require the railroad company to study background levels of dioxins in comparable areas in order to give some context to the test results.

Authorities have focused much of their concern on a 2-mile radius around the spill, but residents that live farther away, including some farmers in nearby Pennsylvania, say they’ve been impacted, too.

Dave Anderson raises grass fed beef 4 miles downwind of East Palestine, in nearby Darlington Township, Pennsylvania. After the derailment, fire and controlled burn of toxic chemicals, the thick black smoke drifted over his Echo Valley Farm.

“As far as the smoke, you could probably see 100 yards,” Anderson told CNN’s Miguel Marquez.

Anderson said his eyes, throat and mouth burned.

The cloud from the spill settled on his pastures and ponds. Anderson said now he’s not sure whether the grassfed cattle he’s raised for years are safe for human consumption.

So far, there’s been no testing of his water, soil or air on his farm.

Pennsylvania’s Department of Environment Protection, or DEP, just visited Anderson’s farm for the first time this week, nearly four weeks after the event.

In a written statement provided to CNN, the Pennsylvania Department of Agriculture said it launched a hotline encouraging those impacted to reach out if they have concerns about livestock or crops.

Also this week, Pennsylvania opened a community resource center in Darlington to help people who want to get their soil or wells tested. The center is also conducting medical exams for residents with health concerns. Adam Ortiz, regional administrator for EPA’s region 3 office, which includes Pennsylvania, said the center has seen about 100 people a day since it opened.

The crash occurred just feet from the Pennsylvania border. The winds typically blow east, toward Pennsylvania. The state is going house to house, testing soil and water in areas closest to the derailment. Anderson said officials are still trying to figure out if they should extend that testing to other areas.

Samuel Wenger and his wife Joyce had their fourth child, Jackson Hayes, a week ago. Wenger said the state’s response has been too slow and lacking in information to know whether Darlington is still a safe place to raise a family.

They only recently were able to get their well tested, and they were told it would take another three weeks to get the results of that testing. They said it was agonizing to bring their newborn son back to their house when they don’t have answers about contamination.

“I feel like I possibly regret the decision every day but here we live paycheck to paycheck, we live within our means, and we don’t have the financial luxury to pack up and move,” Samuel said. “It’s scary.”

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FDA says there’s ‘a lot more work to come’ to improve the way it regulates tobacco products | CNN



CNN
 — 

On Friday, the US Food and Drug Administration’s Center for Tobacco Products announced steps it would take to do a better job regulating tobacco products.

In December, an independent panel of experts said in a report that the FDA’s tobacco program had a number of wide-ranging problems that hindered its ability to regulate the industry and to reduce tobacco-related disease and death.

Although the number of people who smoke is at one of the lowest levels recorded, smoking is still the leading cause of preventable death in the United States. In 2021, about 11.5% of US adults smoked cigarettes, according to the US Centers for Disease Control and Prevention. That’s a decline from the 20.6% who smoked in 2009, but there are still more than 24 million people who smoke cigarettes, according to the CDC.

Each day, about 1,600 young people try their first cigarette. And that doesn’t even include the growing number of kids who use e-cigarettes. In 2022, the CDC found that more than 2.5 million middle and high schoolers reported current e-cigarette use. About 5.66 million adults vape, a 2020 study found.

With the decline in cigarette smoking and what the FDA labeled the “continued innovation” in the e-cigarette industry, “the societal concerns are not subtle,” the agency says in a statement.

“Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products,” FDA Commissioner Dr. Robert Califf said in the statement.

The independent panel – the Reagan-Udall Foundation – generally criticized the FDA for not being proactive enough and said that there was a real lack of clarity from the Center for Tobacco Products, even about its goals. The panel also found that the center had some real communication issues. Critics of the FDA have said that the agency is too slow to act, and it has repeatedly missed even court-ordered deadlines to regulate e-cigarette products.

Dr. Brian King, director of the center, said his division will take a comprehensive approach to reform. The center has reviewed millions of applications for e-cigarette products and rejected millions of applications, it said, but King plans to optimize how the reviews will work.

Alhough e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA asked the manufacturers to submit applications to keep products on the market. The FDA said in March that it had reviewed 99% of the nearly 6.7 million e-cigarette products that have been submitted for premarket authorization, but many of those companies were small players in the market, and there still are several outstanding decisions concerning companies that have a larger share of the market.

Under the new plans for the Center for Tobacco Products, the division will streamline reviews when possible, increase the use of its Tobacco Products Scientific Advisory Committee to discuss broader scientific matters that are the basis for product applications, and better communicate its practices.

The announcement saysthe FDA will continue to advocate for the ability to collect user fees from e-cigarette companies like it does with medical products. It does not have the ability to do that, even although the Center for Tobacco Products says it has a huge workload. That would require authorization from Congress.

The FDA will create a summit to discuss with the US Department of Health and Human Services and the US Department of Justice how it should enforce its compliance work.

The FDA does not have the independent authority to engage in litigation or seize products illegally sold on the market and will have to work with other departments to pursue companies that are in violation of the law.

To address the criticism that the agency was not transparent enough, this spring, the FDA says that it will create a website where it will post what steps it has taken against companies that are found to be in violation of the law.

Just this past week, in a “wakeup call” to the industry, the FDA announced the center’s first civil money penalty complaints against four e-cigarette manufacturers that were in violation of the law for selling e-liquids without getting the FDA’s authorization. Before e-cigarette companies can sell their products, they need to get premarket authorization from the FDA.

The FDA has sent 1,500 warning letters to online sellers, manufacturers and shops that are in violation of the law since 2009. It’s also sent 120,000 warning letters to stores for repeated violations of the law.

The Center for Tobacco Products will immediately begin hiring to create a policy unit within the Office of the Center Director that would help coordinate policy across the tobacco division.

The center also plans to work with others in HHS and the FDA to figure out how to be more efficient in hiring.

By the spring, the center will also publish materials that will help the public understand how it can have input on all of its education campaigns.

The American Lung Association said it was pleased to see the FDA’s response to the Reagan-Udall report and is encouraged that over the past six months, it seems to have improved its commitment to implementing the Tobacco Control Act. The group is, however, encouraging the FDA to do even more.

“FDA must improve its transparency to build trust with the public and the broader health community. We remain disappointed that FDA continues to allow products for which premarket tobacco applications have not been completed to remain on the market,” National President and CEO Harold Wimmer said in a statement.

Friday’s announcement is just the first step of many, the FDA said. It will immediately start work on a five-year strategic plan for release by the end of the year, along with a new comprehensive policy agenda. The FDA said it will have routine updates about the plan throughout the year and will ask for input from the industry and other stakeholders by the summer.

The agency is still working on its product standards that would ban menthol in cigarettes and flavors – other than tobacco flavor – in cigars. It is also looking into whether it should develop a standard that would create a maximum nicotine level so cigarettes and other tobacco products would be less addictive.

“The FDA will continue to undertake our critical work to improve public health,” Califf said. “It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public – not the interests of the tobacco industry – at the forefront. We’ve made progress, but there’s a lot more work to come.”

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Adderall users struggle with ongoing shortage while reason — and resolution — remain uncertain | CNN



CNN
 — 

Clara Pitts has always strived for perfection.

The 17-year-old Utah native has been named a 2023 National Merit Scholarship finalist. And she heads to Brigham Young University as a freshman this fall.

But despite all of her achievements, Clara has one thing weighing on her mind: What if she fails?

Clara was diagnosed with attention-deficit/hyperactivity disorder (ADHD) in 10th grade, during the summer of 2020, after months of digital schooling had started to take its toll.

“For the first time, I started struggling with getting my homework done [and] having a set schedule that I had to do myself,” Clara said. “It was because of online school.”

So along with her mother, Rebekah, she made the decision to try medication.

“I didn’t realize just how much my ADHD was inhibiting me from acting the same way as all of my friends until I had that experience of leveling the playing field,” Clara said.

By December 2020, Clara was prescribed 10 milligrams of Adderall, a formulation of amphetamine mixed salts, to be taken twice a day. Immediately, she noticed a difference.

“It seemed like the logical course of action, like something that shouldn’t have been happening in my brain was being fixed,” Clara said. “Naturally, my brain goes really, really fast, and I don’t even notice it because it’s what I’ve grown up with, and it’s the only mind I’ve ever experienced. But once I started having a different experience mentally, I felt a lot calmer.”

For the two years that followed, Clara was finally able to lead what she called a normal life, managing school, extracurricular activities and social life – all with the help of Adderall.

But in October 2022, Clara’s sense of calm was stripped away when the US Food and Drug Administration announced a shortage of Adderall and its generic counterparts.

“I hadn’t heard anything about a shortage,” she said. “I didn’t really take it seriously at first until later that week – maybe three or four days later – when I started to hear news about the shortage, and it really started to sink in.”

CNN first spoke with Clara and her mother, Rebekah, about a month after the FDA’s announcement. At the time, Clara had eight Adderall pills left in her prescription bottle – enough to last her four days.

“Initially, I was just very surprised when I tried to refill the prescription and they would not [refill it],” Rebekah says. “Very quickly, I went from surprised to afraid.”

On October 24, Rebekah texted Clara the bad news. The shortage had finally affected them, and their pharmacy could not refill Clara’s medication due to the shortage.

“They wouldn’t put you on a waiting list,” Rebekah texted her daughter. “I’m just sitting here crying because I can’t get you these meds.”

Rebekah says she called eight local pharmacies, and each one turned up empty.

“I felt really emotional about it in that first week or two … like I had failed my child, even though it wasn’t my fault,” Rebekah said. “I felt scared for what that would mean for her as a senior.”

The FDA announced a shortage of Adderall on October 12. The agency noted that it was in communication with all manufacturers of amphetamine mixed salts and that one of those companies, Teva, was “experiencing ongoing intermittent manufacturing delays.” Although other manufacturers continued to produce the drug, the agency said, “there is not sufficient supply to continue to meet U.S. market demand through those producers.”

Jim McKinney, a spokesperson for the agency, told CNN that the manufacturing delay has been resolved and that the shortage is now “demand-driven.”

Data from the analytics and research company IQVIA shows that the demand for Adderall has risen nearly 27% in recent years, with prescriptions jumping from 35.5 million in 2019 to 45 million last year.

On its website, the FDA lists eight manufacturers that have reported Adderall shortages to the agency. The website lists the shortage reason for some versions of the drug, such as “demand increase” or “shortage of active ingredient,” but for other versions, it just says “other” or lists no reason at all.

Each year, the Drug Enforcement Administration tracks and sets a limit on production of amphetamine, one of the key ingredients in Adderall. It says that for the past three years, manufacturers didn’t expend all of the ingredients that were available for their use.

“DEA is committed to ensuring that all Americans can readily access needed medications,” an agency spokesperson told CNN in a statement. “We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs. Based on DEA’s information – which is provided by drug manufacturers – this is not true.”

CNN reached out to the eight manufacturers that reported shortages to the FDA.

Teva Pharmaceuticals, Epic Pharma and Rhodes Pharmaceuticals did not respond. Alvogen, SpecGX and Sunrise Pharmaceutical declined to comment.

Sandoz said it had enough product to meet current customer orders. Lannett also said it had enough to meet current customer orders but added that it did not have enough to fulfill increased demand.

McKinney, the FDA spokesperson, said supply is increasing.

“The FDA recognizes the potential impact that reduced availability of certain products may have on health care providers and patients and is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” he said.

McKinney clarified that although the FDA is working with manufacturers, the agency does not make drugs and “cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.”

Dr. Yoram Unguru, a pediatric hematologist and oncologist with joint faculty appointments at the Herman & Walter Samuelson Children’s Hospital at Sinai and the Johns Hopkins Berman Institute of Bioethics, studies drug shortages.

He says a lack of transparency about details – how big the shortage is and how much drug each company is making – is hindering solutions.

“Pharmaceutical manufacturers are not required to disclose the reason for disrupted supply. Knowing the exact reason for a given shortage is always challenging,” Unguru said. “It’s really difficult to be able to anticipate and let alone come up with meaningful solutions if you don’t know what the problem is.”

Clara ultimately went without Adderall for two and half months as she coped with the stresses of senior year. She began taking a different ADHD medication, Vyvanse, in mid-January.

Rebekah says she hopes Adderall will be an option for Clara again one day, adding that she doesn’t have the emotional stamina to keep searching for the medication.

“I would like her to have medication as an option and for it to be reliable, because college will probably be the hardest journey for her with ADHD.”

Clara says that life without Adderall is like trying to see the world vividly while wearing smudged glasses.

“You go around with dirty glasses. You get used to it, and you don’t realize that they’re dirty. But when you clean them off, having that extra bit of clarity makes a world of difference.”

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Thousands of people can’t get full treatments of a lifesaving cancer drug | CNN



CNN
 — 

Dino Carlone was frightened when he was diagnosed with bladder cancer three years ago, but his spirits were buoyed when he learned that he could get help from a highly effective drug with a great track record.

“You’re telling yourself, ‘OK, I have cancer, and it’s a very aggressive cancer, but I’ve got great therapy. There’s great numbers,’ ” said Carlone, 65.

Carlone was supposed to receive treatment for several years, but he says he only got it for only a few months because his urologist told him there was a shortage of the drug, called Bacillus Calmette-Guérin, or BCG.

Carlone said he was shocked and angry that in a country as wealthy as the United States, there’s a shortage of an important cancer drug.

A new report estimates that more than 8,300 US patients a year are not receiving full BCG treatments for their bladder cancer. BCG is an older drug – it has been around for more than 40 years – and relatively inexpensive. Pharmaceutical companies aren’t clamoring to make it.

“This is a terrible crisis. We should be doing everything we can to give every single one of these patients the best chance of survival,” said Laura Bray, a board member of the End Drug Shortages Alliance, one of the sponsors of the report. “It’s heartbreaking, and we must do better.”

A spokesperson for Merck, the sole maker worldwide of BCG, wrote in an emailed statement that the company increased production of the drug by 200% between 2012 and 2019 and has been producing it “to the full extent of manufacturing capacity over the past several years.”

Merck is building a facility to expand production of BCG. The company expects the facility to be completed sometime between late 2025 and late 2026, which includes time for necessary regulatory approvals, according to the statement.

“Our company will continue to work to complete this project and meet patient needs in as timely a manner as possible. Our commitment to [BCG] is at the core of Merck’s mission to save and improve lives. We continue to recognize the impact supply shortages can have on patients when they cannot receive the medicines they need,” the statement says.

A number of factors are contributing to the shortage, which began in 2019. BCG is a biologic drug – which uses bacteria – and so is more complicated to make than many other types of drugs and especially prone to quality control issues.

Sanofi, the other company that once made BCG, started having production problems in 2012. In 2016, it announced that it would stop making the drug the next year.

Also, while cases of bladder cancer are slowly increasing, it’s still a relatively small market, and making the drug requires a significant investment.

In a written statement, a spokesperson for the US Food and Drug Administration said that “whenever a shortage occurs, FDA actively works with manufacturers and other U.S. federal agencies to try to address supply issues for the drug product in shortage.”

When BCG became available in 1976, it was considered a breakthrough strategy. First used as a tuberculosis vaccine, it contains a weakened bacteria that triggers the immune system to fight the cancer.

“It’s an absolutely fabulous drug,” said Dr. Benjamin Davies, a spokesperson for the American Urological Association.

Bladder cancer patients receive six rounds of BCG after surgery and then more treatments every few months for a year or two, depending on the person, according to Davies. The treatment is done in the doctor’s office, using a catheter that delivers the drug directly to the bladder.

Carlone, of Vero Beach, Florida, said he was supposed to receive BCG doses over a period of about two years. But he said after receiving doses for a few months in early 2020, his urologist told him he wouldn’t be able to get his remaining doses because of the shortage.

“It’s a very, very frightening circumstance to realize that at that point, what they deem to be an aggressive cancer could in fact come right back,” he said.

Bladder cancer has a 30% to 40% recurrence rate, said Davies, a professor of urology at the University of Pittsburgh Medical Center.

“That’s a very high recurrence rate,” he said. “It’s a nasty disease.”

There are about 82,920 new cases of bladder cancer in the US a year and 16,710 deaths, according to the American Cancer Society.

For the new report, 20 health care systems and physician practices responded to a survey from Vizient, a health care performance improvement company.

All of them said they had to use at least one strategy to deal with the BCG shortage, and four of the centers said they couldn’t give BCG at all, according to the report.

Because of the shortage, the American Urological Association recommends prioritizing doses for higher-risk patients.

Some medical centers in the survey said they are splitting doses. A vial is supposed to be used for one dose for one patient, but instead, they use it for more than one patient. That could lead to waste, though, because the entire vial needs to used within six hours of opening, said Erin Fox, an adjunct professor at the University of Utah College of Pharmacy and specialist in drug shortages.

Other drugs can be used instead of BCG, but they are more expensive and don’t work as well, Davies said.

“So not only can’t we give the right drug because of the shortage, but we have to spend more money,” he said.

BCG is just one of many drugs in shortage, including other cancer drugs for adults and for children.

Carlone wonders why the FDA can’t do more to persuade companies to make drugs that aren’t necessarily very lucrative.

“To me, this is a failure,” he said. “As Americans, you rely on [government] institutions, and the institutions are failing as far as I’m concerned.”

According to the FDA statement, the agency “cannot require a pharmaceutical company to make a drug – or make more of a drug – even if it is medically necessary. In addition, we cannot control how much of a drug is distributed – or which purchasers will be given priority.”

Marta Wosińska, a former senior FDA official, said the federal government could offer financial incentives for pharmaceutical companies to make drugs that are in shortage, similar to the way the government has paid them to make Covid-19 vaccines and treatments.

Wosińska, an economist at the Brookings Institution, said it would be “a little bit of a tall order” to expect pharmaceutical companies to make drugs, or increase production of drugs, that aren’t particularly profitable.

“They have a fiduciary responsibility to their shareholders, so you can only ask them to do so much,” said Wosińska, who worked on drug shortages as director of the economics staff at the FDA’s Center for Drug Evaluation and Research before she left the agency in 2016.

Dr. Yoram Unguru, a member of the core faculty at the Johns Hopkins Berman Institute of Bioethics, said that “pharmaceutical companies can continue to generate profits while ensuring access to essential medicines.”

He added that the government has an obligation to fix these shortages.

“The federal government must take a more hands-on approach and maintain a critical stockpile of essential lifesaving medicines and set prices for medications, akin to existing rate-setting bodies that oversee public utilities,” he said.

The BCG shortage is expected to continue for years.

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First on CNN: HHS secretary sends letter to state governors on what’s to come when Covid-19 public health emergency ends | CNN



CNN
 — 

Plans are moving forward at the US Department of Health and Human Services to prepare for the end of the nation’s Covid-19 public health emergency declaration in May.

On Thursday, HHS Secretary Xavier Becerra sent a letter and fact sheet to state governors detailing what exactly the end of the emergency declaration will mean for jurisdictions and their residents.

“Addressing COVID-19 remains a significant public health priority for the Administration, and over the next few months, we will transition our COVID-19 policies, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients. We will work closely with partners including state, local, Tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition,” Becerra wrote in a draft of the letter obtained by CNN.

“In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE,” he wrote. “I will share that resource with your team when available.”

Declaring a public health emergency in the United States means that certain actions, access to funds, grants, waivers and data – among other steps – can happen more quickly in response to the crisis for the duration of the emergency. A declaration lasts 90 days – unless HHS ends it – and may be renewed.

On January 30, the White House announced its intention to end the Covid-19 national and public health emergencies on May 11, signaling that the administration considers the nation to have moved out of the emergency response phase.

Becerra had agreed to give governors a 60-day notice to prepare for the end of the emergency. Thursday’s letter was sent 90 days ahead of the emergency’s planned end.

“We are having ongoing conversations about what else we need to do in the next 90 days to ensure a smooth transition. I can tell you that every one of our agencies has been working hard on this plan,” an HHS official told CNN. “We’re going to have a series of additional materials that will go out, as well as a series of conversations over the coming days and weeks.”

The end of the public health emergency will affect some Medicare and state Medicaid flexibilities provided for the duration of the emergency. This includes waivers like the requirement for a three-day hospital stay before Medicare will cover care at a skilled nursing facility.

“We’ve been working closely with the governors on the public health emergency. This is a combination of both federal flexibilities that we allow, and the states are often the ones who are using those flexibilities,” the HHS official said.

“Just about every aspect of the pandemic response, I would say, has been in partnership with our state partners. And so, I think they have been, frankly for months now, the ones that we have been going to and the ones that we publicly committed to notifying in advance of changes to the public health emergency declaration.”

But the emergency’s end will not impact the authorizations of Covid-19 devices, including tests, vaccines and treatments that have been authorized for emergency use by the US Food and Drug Administration.

During the Covid-19 pandemic, the FDA has issued about 15 times as many emergency use authorizations as it did for all other previous public health emergencies, Commissioner Dr. Robert Califf said Wednesday in a joint hearing of the House Oversight and Investigations and Health subcommittees.

“Today, we’ve issued EUAs or provided traditional marketing authorizations to over 2,800 medical devices for Covid-19, which is 15 times more EUAs than all other previous emergencies combined,” Califf said. He added that the effects of the end of the emergency declaration will be “modest” because the “EUAs are independent of the public health emergency, so we can keep them going as long as we need to.”

The emergency is slated to end May 11. “What happens on May 12? On May 12, you can still walk into a pharmacy and get your bivalent vaccine,” Dr. Ashish Jha, the White House’s coronavirus response coordinator, wrote on Twitter last week.

He said that at some point, probably in the summer or early fall, the Biden administration will transition from federal distribution of Covid-19 vaccines and treatments to purchases through the regular health care system – but that’s not happening quite yet.

Overall, there are additional Medicaid waivers and other flexibilities that states and territories have received under the public health emergency. Some of those will be terminated. But state Medicaid programs will have to continue covering Covid-19 testing, treatments, and vaccinations without cost-sharing through September 30, 2024.

The end of the public health emergency declaration means Medicare beneficiaries will face out-of-pocket costs for over-the-counter home Covid-19 tests and treatment. However, people with Medicare will continue to have no cost for medically necessary lab-conducted Covid-19 tests ordered by their health care providers.

Covid-19 vaccinations will continue to be covered at no cost for all Medicare beneficiaries.

Those with private insurance could face charges for lab tests, even if they are ordered by a provider, according to the Kaiser Family Foundation. Vaccinations will continue to be free for those with private insurance who go to in-network providers, but going to an out-of-network providers could incur charges once federal supplies run out.

And the privately insured will not be able to get free at-home tests from pharmacies and retailers anymore unless their insurers choose to cover them.

Americans with private insurance have not been charged for monoclonal antibody treatment since they were prepaid by the federal government, though patients may be charged for the office visit or administration of the treatment, according to Kaiser. But that is not tied to the public health emergency, and the free treatments will be available until the federal supply is exhausted. The government has already run out of some of the treatments so those with private insurance may already be picking up some of the cost.

The uninsured had been able to access no-cost testing, treatments and vaccines through a different pandemic relief program. However, the federal funding ran out in the spring of 2022, making it more difficult for those without coverage to obtain free services.

Also, the “ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities,” according to the letter’s fact sheet.

One of the most meaningful pandemic enhancements for states is no longer tied to the public health emergency. Congress severed the connection in December as part of its fiscal year 2023 government funding package, which state Medicaid officials had urged lawmakers to do.

States will now be able to start processing Medicaid redeterminations and disenrolling residents who no longer qualify, starting April 1. They have 14 months to review the eligibility of their beneficiaries.

As part of a Covid-19 relief package passed in March 2020, states were barred from kicking people off Medicaid during the public health emergency in exchange for additional federal matching funds. Medicaid enrollment has skyrocketed to a record 91 million people since then.

A total of roughly 15 million people could be dropped from Medicaid when the continuous enrollment requirement ends, according to an analysis the Department of Health and Human Services released in August. About 8.2 million folks would no longer qualify, but 6.8 million people would be terminated even though they are still eligible, the department estimated.

Many who are disenrolled from Medicaid, however, could qualify for other coverage.



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Mpox is almost gone in the US, leaving lessons and mysteries in its wake | CNN



CNN
 — 

The US public health emergency declaration for mpox, formerly known as monkeypox, ends Tuesday.

The outbreak, which once seemed to be spiraling out of control, has quietly wound down. The virus isn’t completely gone, but for more than a month, the average number of daily new cases reported to the US Centers for Disease Control and Prevention has hovered in the single digits, plummeting from an August peak of about 450 cases a day.

Still, the US led the world in cases during the 2022-23 outbreak. More than 30,000 people in the US have been diagnosed with mpox, including 23 who died.

Cases are also down across Europe, the Western Pacific and Asia but still rising in some South American countries, according to the latest data from the World Health Organization.

It wasn’t always a given that we’d get here. When mpox went global in 2022, doctors had too few doses of a new and unproven vaccine, an untested treatment, a dearth of diagnostic testing and a difficult line to walk in their messaging, which needed to be geared to an at-risk population that has been stigmatized and ignored in public health crises before.

Experts say the outbreak has taught the world a lot about this infection, which had only occasionally been seen outside Africa.

But even with so much learned, there are lingering mysteries too – like where this virus comes from and why it suddenly began to spread from the Central and West African countries where it’s usually found to more than 100 other nations.

Before May 2022, when clusters of people with unusual rashes began appearing in clinics in the UK and Europe, the country reporting the most cases of mpox was the Democratic Republic of Congo, or DRC.

There, cases have been steadily building since the 1970s, according to a study in the CDC’s Morbidity and Mortality Weekly Report.

In the DRC, people in rural villages depend on wild animals for meat. Many mpox infections there are thought to be the result of contact with an animal to which the virus has adapted; this animal host is not known but is assumed to be a rodent.

For years, experts who studied African outbreaks observed a phenomenon known as stuttering chains of transmission: “infections that managed to transmit themselves or be transmitted from person to person to a limited degree, a certain number of links in that chain of transmission, and then suddenly just aren’t able to sustain themselves in humans,” said Stephen Morse, an epidemiologist at Columbia University’s Mailman School of Public Health.

Informally, scientists kept track, and Morse says that for years, the record for links in a mpox chain was about four.

“Traditionally, it always burned itself out,” he said.

Then the chains started getting longer.

In 2017, Nigeria – which hadn’t had a confirmed case of mpox in more than four decades – suddenly saw a resurgence of the virus, with more than 200 cases reported that year.

“People have speculated maybe it was a change in the virus that allowed it to be made better-adapted to humans,” Morse said.

From 2018 through 2021, eight cases of mpox were reported outside Africa. All were in men ages 30 to 50, and all had traveled from Nigeria. Three reported that the rashes had started in their groin area. One went on to infect a health care provider. Another infected two family members.

This Nigerian outbreak helped experts realize that mpox could efficiently spread between people.

It also hinted that the infection could be sexually transmitted, but investigators couldn’t confirm this route of spread, possibly because of the stigma involved in sharing information about sexual contact.

In early May 2022, health officials in the UK began reporting confirmed cases of mpox. One of the people had recently traveled to Nigeria, but others had not, indicating that it was spreading in the community.

Later, other countries would report cases that had started even earlier, in April.

Investigators concluded that mpox had been silently spreading before they caught up to it.

In early summer, as US case numbers began to grow, the public health response bore some uncomfortable similarities to the early days of Covid-19. People with suspicious rashes complained that it was too hard to get tested because a limited supply was being rationed. Because the virus had so rarely appeared outside certain countries in Africa, most doctors weren’t sure how to recognize mpox or how to test for it and didn’t understand all its routes of spread.

A new vaccine was available, and the government had placed orders for it, but most of those doses weren’t in the United States. Beyond that, its efficacy against mpox had been studied only in animals, so no one knew whether it would actually work in humans.

There was an experimental treatment, Tpoxx, but it too was unproven, and doctors could get it only after filling out reams of paperwork required by the government for compassionate use.

Some just gave up.

“Tpoxx was hard to get,” said Dr. Jeffrey Klausner, a clinical professor of public health at the University of Southern California’s Keck School of Medicine.

“I was scrambling to find places that could prescribe it because my own institution just became a bureaucratic nightmare. So I basically would be referring people for treatment outside my own institution to be able to get monkeypox treatment,” he said.

Finally, in August, the federal government declared a public health emergency. This allowed federal agencies to access pots of money set aside for emergencies. It also allows the government to shift funds from one purpose to another to help cover costs of the response – and it helped raise awareness among doctors that mpox was something to watch for.

The government also set up a task force led by Robert Fenton, a logistics expert from the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, director of the CDC’s Division of HIV and AIDS Research.

Daskalakis is openly gay and sex-positive, right down to his Instagram account, which mixes suit-and-tie shots from White House briefings with photos revealing his many tattoos.

“Dr. Daskalakis … really walks on water in most of the gay community, and then [Fenton is] a logistics expert, and I think that combination of leadership was the right answer,” Klausner said.

Early on, after the CDC identified men who have sex with men as being at highest risk of infection, officials warned of close physical contact, the kind that often happens with sexual activity. They also noted that people could be infected through contact with contaminated surfaces like sheets or towels.

But they stopped short of calling it a sexually transmitted infection, a move that some saw as calculated.

“In this outbreak, in this time and context to Europe, United States and Australia, was definitely sexually transmitted,” said Klausner, who points out that many men got rashes on their genitals and that infectious virus was cultured in semen.

Klausner believes vague descriptions about how the virus spread were intentional, in order to garner resources needed for the response.

“People felt that if they called it an STD from the get-go, it was going to create stigma, and because of the stigma of the type of sex that was occurring – oral sex, anal sex, anal sex between same-sex male partners – there may not have been the same kind of federal response,” Klausner said. “So it was actually a political calculation to garner the resources necessary to have a substantial response to be vague about how it spread.”

This ambiguity created room for misinformation and confusion, said Tony Hoang, executive director of Equality California, a nonprofit advocacy group for LGBTQ civil rights.

“I think there was a balancing dance of not wanting to create stigma, in terms of who is actually the highest rates of transmission without being forthright,” Hoang said.

Hoang’s group launched its own public information campaign, combining information from the CDC on HIV and mpox. The messaging stressed that sex was the risky behavior and made sure to explain that light brushes or touches weren’t likely to pass the infection, he said.

Klausner thinks the CDC could have done better on messaging.

“By giving vague, nonspecific information and making comments like ‘everyone’s potentially at risk’ or ‘there’s possible spread through sharing a bed, clothing or close dancing’ … that kind of dilutes the message, and people who engage in risk behavior that does put them at risk get confused, and they say ‘well, maybe this isn’t really a route of spread,’ ” he said.

In July and August, when the US was reporting hundreds of new mpox cases each day, health officials were worried that the virus might be here to stay.

“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” said Dr. Jonathan Mermin, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.

“We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real,” he said.

At the peak of the outbreak, officials scrambled to vaccinate the population at highest risk – men who have sex with men – in the hopes of limiting both severity of infections and transmission. But no one was sure whether this strategy would work.

The Jynneos vaccine was approved by the US Food and Drug Administration in 2019 to prevent monkeypox and smallpox in people at high risk of those infections.

At that time, the plan was to bank it in the Strategic National Stockpile as a countermeasure in case smallpox was weaponized. The approval for mpox, a virus closely related to smallpox, was tacked on because the US had seen a limited outbreak of these infections in 2003, tied to the importation of exotic rodents as pets.

Jynneos had passed safety tests in humans. In lab studies, it protected primates and mice from mpox infections. But researchers only learn how effective vaccines are during infectious disease outbreaks, and Jynneos has never been put through its paces during an outbreak.

“We were left, when this started, with that great unknown: Does this vaccine work? And is it safe in large numbers?” Mermin said.

Beyond those uncertainties, there wasn’t enough to go around, and infectious disease experts feared that a shortage of the vaccine might thwart any effort to stop the outbreak.

So public health officials announced a change in strategy: Instead of injecting a full dose under the skin, or subcutaneously, they would inject just one-fifth of that dose between the skin’s upper layers, or intradermally.

An early study in the trials of the vaccine had suggested that intradermal dosing could be effective, but it was a risk. Again, no one was sure this dose-sparing strategy would work.

Ultimately, all of these gambles appear to have paid off.

Early studies of vaccine effectiveness show that the Jynneos vaccine protected men from mpox infections. According to CDC data, people who were unvaccinated were almost 10 times as likely to be diagnosed with the infection as those who got the recommended two doses.

Men who had two doses were about 69% less likely, and men with a single dose were about 37% less likely, to have an mpox infection that needed medical attention compared with those who were unvaccinated, according to the CDC.

Mermin says studies have since showed that the vaccine worked well no matter if was given into the skin or under the skin – another win.

Still, the vaccine is almost certainly not the entire reason cases have plunged, simply because not enough people have gotten it. The CDC estimates that 2 million people in the United States are eligible for mpox vaccination. Mermin says that about 700,000 have had a first dose – about 36% of the eligible population.

So it’s unlikely that vaccination was the only reason for the steep decline in cases. CDC modeling suggests that behavior change may have played a substantial role, too.

In an online survey of men who have sex with men conducted in August, half of participants indicated that they had reduced their number of partners and one-time sexual encounters, behaviors that could cut the growth of new infections by 20% to 30%.

If that’s the case, some experts worry that the US could see monkeypox flare up again as the weather warms.

“The party season was during the summer, during the height of the outbreak, and we’re in the dead of winter. So there’s a possibility that behavior change may not able to be sustained,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health.

Although we’re clearly in a much better position than we were last summer, he says, public health officials shouldn’t make this a “mission accomplished” moment.

“Now, put your foot on the accelerator. Let’s get the rest of these cases,” Gonsalves said.

Mermin says that’s exactly what the CDC intends to do. It isn’t finished with the response but intends to switch to “a ground game.”

“So much of our work in the next few months will be setting up structures so that getting vaccinated is easy,” he said.

Nearly 40% of mpox cases in the United States were diagnosed in people who also had HIV, Mermin said. So the CDC is going to make sure Jynneos vaccines are available as a routine part of care at HIV clinics and STI clinics that offer pre-exposure prophylaxis, or PrEP, for HIV.

Mermin said officials are also going to continue to go to LGBTQ festivals and events to offer on-site vaccinations.

Additionally, they’re going to study people who’ve been vaccinated and infected to see whether they remain immune – something else that’s still a big unknown.

Experts say that’s just one of many questions that need a closer look. Another is just how long the virus had been spreading outside Africa before the world noticed.

“We’re starting to see some data that suggests that asymptomatic infection and transmission is possible, and that certainly will change how we how we think about this virus and and risk,” said Anne Rimoin, an epidemiologist at the Fielding School of Public Health at UCLA.

When researchers at a sexual health clinic in Belgium rescreened more than 200 nasal and oral swabs they had taken in May 2022 to test for the STIs chlamydia and gonorrhea, they found positive mpox cases that had gone undiagnosed. Three of the people reported no symptoms, while another reported a painful rash, which was misdiagnosed as herpes. Their study was published in the journal Nature Medicine.

“Mild and asymptomatic infections may have indeed delayed the detection of the outbreak,” study author Christophe Van Dijck of the Laboratory of Medical Microbiology at the University of Antwerp in Belgium said in an email to CNN.

While researchers tackle those pursuits, advocacy groups say they aren’t ready to relax.

Hoang says Equality California is pushing the CDC to address continuing racial disparities in mpox vaccination and treatment, particularly in rural areas.

He’s not worried that gay men will drop their guard now that the emergency has expired..

“We’ve learned that we have to take health into our own hands, and I do think that we will remain vigilant as a community for this outbreak and future outbreaks,” Hoang said.



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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN



CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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FDA proposes new levels for lead in baby food, but critics say more action is needed | CNN



CNN
 — 

The allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidance issued Tuesday by the US Food and Drug Administration.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” said FDA Commissioner Dr. Robert Califf in a statement.

The

Baby foods covered by the new proposal – which is seeking public comment – include processed baby foods sold in boxes, jars, pouches and tubs for babies and young children younger than 2 years old, the agency said.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies’ exposures to neurotoxic chemicals.

“Nearly all baby foods on the market already comply with what they have proposed,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of manufactured baby food.

That report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals.

“The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable,” Houlihan said.

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

Exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior,” according to the American Academy of Pediatrics.

Lead, arsenic, cadmium and mercury are in the World Health Organization’s top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can’t be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

The new FDA guidance suggests manufactured baby food custards, fruits, food mixtures — including grain and meat-based blends — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion of lead.

The exception to that limit is for single-ingredient root vegetables, such as carrots and sweet potatoes, which should contain no more than 20 parts per billion, according to the new guidance.

Dry cereals marketed to babies and toddlers should also not contain more than 20 parts per billion of lead, the new FDA guidance said.

However, the FDA didn’t propose any lead limit for cereal puffs and teething biscuits, Houlihan said, even though the products account for “7 of the 10 highest lead levels we’ve found in over 1,000 baby food tests we have assessed.”

The limit set for root vegetables will be helpful, Houlihan added. Because they grow underground, root vegetables can easily absorb heavy metals. For example, sweet potatoes often exceed the 20 parts per billion limit the FDA has proposed, she said.

Prior to this announcement, the FDA had only set limits for heavy metals in one baby food — infant rice cereal, Houlihan said. In 2021, the agency set a limit of 100 parts per billion for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.

There is much more that can be done, according to Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit environmental health organization.

“We can change where we farm and how we farm to reduce toxic metals absorbed by plants,” Faber said. “We also urge baby food manufacturers to conduct continuous testing of heavy metals in all their products and make all testing results publicly available.”

Companies can require suppliers and growers to test the soil and the foods they produce, and choose to purchase from those with the lowest levels of heavy metals, Houlihan added.

“Growers can use soil additives, different growing methods and crop varieties known to reduce lead in their products,” she said.

What can parents do to lessen their child’s exposure to toxic metals? Unfortunately, buying organic or making baby food at home isn’t going to solve the problem, as the produce purchased at the grocery store can also contain high levels of contaminants, experts say.

A 2022 report by Healthy Babies, Bright Futures found lead in 80% of homemade purees or store-bought family foods. Arsenic was found in 72% of family food either purchased or prepared at home.

The best way to lessen your child’s exposure to heavy metals, experts say, is to vary the foods eaten on a daily basis and choose mostly from foods which are likely to have the least contamination. Healthy Babies, Bright Futures created a chart of less to most contaminated foods based on their testing.

Fresh bananas, with heavy metal levels of 1.8 parts per billion, were the least contaminated of foods tested for the report. After bananas, the least contaminated foods were grits, manufactured baby food meats, butternut squash, lamb, apples, pork, eggs, oranges and watermelon, in that order.

Other foods with lower levels of contamination included green beans, peas, cucumbers and soft or pureed home-cooked meats, the report found.

The most heavily contaminated foods eaten by babies were all rice-based, the report said. Rice cakes, rice puffs, crisped rice cereals and brown rice with no cooking water removed were heavily contaminated with inorganic arsenic, the more toxic form of arsenic.

After rice-based foods, the analysis found the highest levels of heavy metals in raisins, non-rice teething crackers, granola bars with raisins and oat-ring cereals. But those were not the only foods of concern: Dried fruit, grape juice, arrowroot teething crackers and sunflower seed butter all contained high amounts of at least one toxic metal, according to the report.

While buying organic cannot reduce the levels of heavy metals in infant food, it can help avoid other toxins such as herbicides and pesticides, Dr. Leonardo Trasande, director of environmental pediatrics at NYU Langone Health told CNN previously.

“There are other benefits to eating organic food, including a reduction in synthetic pesticides that are known to be as bad for babies, if not even more problematic,” Trasande said.

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Flu, Covid-19 and RSV are all trending down for the first time in months | CNN



CNN
 — 

A rough respiratory virus season in the US appears to be easing, as three major respiratory viruses that have battered the country for the past few months are finally all trending down at the same time.

A new dataset from the US Centers for Disease Control and Prevention shows that the number of emergency department visits for the three viruses combined – flu, Covid-19 and RSV – have dropped to the lowest they’ve been in three months. The decline is apparent across all age groups.

Measuring virus transmission levels can be challenging; health officials agree that Covid-19 cases are vastly undercounted, and surveillance systems used for flu and RSV capture a substantial, but incomplete picture.

But experts say that tracking emergency department visits can be a good indicator of how widespread – and severe – the respiratory virus season is.

“There’s the chief complaint. When you show up to the emergency room, you complain about something,” said Janet Hamilton, executive director at Council of State and Territorial Epidemiologists. “Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season.”

In the week following Thanksgiving, emergency department visits for respiratory viruses topped 235,000 – matching rates from last January, according to the CDC data.

While the surge in emergency department visits early in the year was due almost entirely to Omicron, the most recent spike was much more varied. In the week ending December 3, about two-thirds of visits were for flu, about a quarter were for Covid-19 and about 10% were for RSV.

Grouping the impact of all respiratory viruses together in this way offers an important perspective.

“There’s a strong interest in thinking about respiratory diseases in a more holistic way,” Hamilton said. “Transmission is the same. And there are certain types of measures that are good protection against all respiratory diseases. So that could really help people understand that when we are in high circulation for respiratory diseases, there are steps that you can take – just in general.”

Now, Covid-19 again accounts for most emergency department visits but flu and RSV are still the reason behind about a third of visits – and they’re all trending down for the first time since the respiratory virus season started picking up in September.

More new data from the CDC shows that overall respiratory virus activity continues to decline across the country. Only four states, along with New York City and Washington, DC, had “high” levels of influenza-like illness. Nearly all states were in this category less than a month ago.

Whether that pattern will hold is still up in the air, as vaccination rates for flu and Covid-19 are lagging and respiratory viruses can be quite fickle. Also, while the level of respiratory virus activity is lower than it’s been, it’s still above baseline in most places and hospitals nationwide are still about 80% full.

RSV activity started to pick up in September, reaching a peak in mid-November when 5 out of every 100,000 people – and 13 times as many children younger than five – were hospitalized in a single week.

RSV particularly affects children, and sales for over-the-counter children’s pain- and fever-reducing medication were 65% higher in November than they were a year before, according to the Consumer Healthcare Products Association. While “the worst may be over,” demand is still elevated, CHPA spokesperson Logan Ramsey Tucker told CNN in an email – sales were up 30% year-over-year in December.

But this RSV season has been significantly more severe than recent years, according to CDC data. The weekly RSV hospitalization rate has dropped to about a fifth of what it was two months ago, but it is still higher than it’s been in previous seasons.

Flu activity ramped up earlier than typical, but seems to have already reached a peak. Flu hospitalizations – about 6,000 new admissions last week – have dropped to a quarter of what they were at their peak a month and a half ago, and CDC estimates for total illnesses, hospitalizations and deaths from flu so far this season have stayed within the bounds of what can be expected. It appears the US has avoided the post-holiday spike that some experts cautioned against, but the flu is notoriously unpredictable and it’s not uncommon to see a second bump later in season.

The Covid-19 spike has not been as pronounced as flu, but hospitalizations did surpass levels from the summer. However, the rise in hospitalizations that started in November has started to tick down in recent weeks and CDC data shows that the share of the population living in a county with a “high” Covid-19 community level has dropped from 22% to about 6% over the past two weeks.

Still, the XBB.1.5 variant – which has key mutations that experts believe may be helping it to be more infectious – continues to gain ground in the US, causing about half of all infections last week. Vaccination rates continue to lag, with just 15% of the eligible population getting their updated booster and nearly one in five people remain completely unvaccinated.

Ensemble forecasts published by the CDC are hazy, predicting a “stable or uncertain trend” in Covid-19 hospitalizations and deaths over the next month.

And three years after the first Covid-19 case was confirmed in the US, the virus has not settled into a predictable pattern, according to Dr. Maria Van Kerkhove, the World Health Organization’s technical lead for the Covid-19 response.

“We didn’t need to have this level of death and devastation, but we’re dealing with it, and we are doing our best to minimize the impact going forward,” Van Kerkhove told the Conversations on Healthcare podcast this week.

Van Kerkhove says she does believe 2023 could be the year in which Covid-19 would no longer be deemed a public health emergency in the US and across the world, but more work needs to be done in order to make that happen and transitioning to longer-term respiratory disease management of the outbreak will take more time.

“We’re just not utilizing [vaccines] most effectively around the world. I mean 30% of the world still has not received a single vaccine,” she said. “In every country in the world, including in the US, we’re missing key demographics.”

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