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

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CNN
—

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

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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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High levels of chemicals could pose long-term risks at Ohio train derailment site, researchers say | CNN

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CNN
—

An analysis of data from the US Environmental Protection Agency’s measurements of pollutants released from the Norfolk Southern train derailment in East Palestine, Ohio, suggests that nine of the dozens of chemicals that the EPA has been monitoring are higher than would normally be found in the area, according to a group of scientists from Texas A&M and Carnegie Mellon University.

If the levels of some of these chemicals remain high, it could be a problem for residents’ health in the long term, the scientists say. Temperature changes or high winds might stir up the chemicals and release them into the atmosphere.

The highest levels found in East Palestine were of a chemical called acrolein, the analysis says.

Acrolein is used to control plants, algae, rodents and microorganisms. It is a clear liquid at room temperature, and it is toxic. It can cause inflammation and irritation of the skin, respiratory tract and mucous membranes, according to the US Centers for Disease Control and Prevention.

“It’s not elevated to the point where it’s necessarily like an immediate ‘evacuate the building’ health concern,” said Dr. Albert Presto, an associate research professor of mechanical engineering at Carnegie Mellon’s Wilton E. Scott Institute for Energy Innovation, who is working on the university’s chemical monitoring effort in East Palestine. “But, you know, we don’t know necessarily what the long-term risk is or how long that concentration that causes that risk will persist.”

Much of what scientists know about chemical exposure comes from people’s contact with chemicals at work, Preston said, which generally means exposure for about eight hours a day. People now living in East Palestine are in constant contact with the chemicals, he said, and the impact of that kind of exposure on the human body is not fully understood.

The EPA and local government officials have repeatedly said that their tests show the air quality in the area is safe and that the chemicals should dissipate. As of Sunday, officials have tested air in 578 homes, and they say chemical pollution levels have not exceeded residential air quality standards.

EPA’s air monitoring data shows that levels of monitored chemicals “are below levels of concern for adverse health impacts from short-term exposures,” an agency spokesperson told CNN on Monday. “The long-term risks referenced by this analysis assume a lifetime of exposure, which is constant exposure over approximately 70 years. EPA does not anticipate levels of these chemicals will stay high for anywhere near that. We are committed to staying in East Palestine and will continue to monitor the air inside and outside of homes to ensure that these levels remain safe over time.”

However, residents have reported rashes and trouble breathing, sometimes even in their own homes, Presto said.

“When someone says to them then, ‘everything is fine everywhere,’ if I were that person, I wouldn’t believe that statement,” he said.

So who’s right? The scientists say it’s not a black-and-white issue.

“I think it’s important for the public to understand that all sides are right. No one’s lying to them,” said Dr. Ivan Rusyn, director of the Texas A&M University Superfund Research Center and part of the team that did the analysis. “It’s just that every time you’re sharing information, whether it’s Administrator of EPA Michael Regan or Governor [Mike] DeWine or someone from Ohio EPA, when they say certain things are ‘safe,’ they really need to explain what they mean.”

Rusyn says the EPA and local officials need to do a better job of communicating with the public about the risk to residents when they are exposed to chemicals released in the crash.

Communication struggles have been a consistent pattern over the years and over numerous environmental disasters, he said. Officials will often do a good job of collecting and releasing data but then fail to give the proper context that the public will understand.

“That’s what I would like to encourage all parties to do rather than to point fingers,” Rusyn said. “The general public has to trust authorities. Cleanup is continuing. They are doing monitoring. We just need to do a better job communicating the results.”

Government communication about residents’ real level of risk has been a significant source of frustration in East Palestine, Presto said.

“People are furious. They feel like they’re getting this black-and-white answer – things are safe or not safe – when it’s not a black-and-white sort of situation,” Presto said.

The EPA says it will continue to monitor the air quality in the area and in residents’ homes. It is also setting up a community center so residents and business owners can ask questions about agency activity there.

The agency said it is collecting outdoor air samples for contaminants of concern, including vinyl chloride, a hard plastic resin used to make plastic products like pipes or packaging material that can be a cancer concern; n-butyl acrylate a clear liquid used to make resins and paint products that can cause eye, throat, nose and lung irritation or damage as well as a skin allergy; and ethylhexyl acrylate, another colorless liquid used to make paints, plastics and adhesives that can cause skin and eye irritation.

The EPA also collected field measurements for hydrogen sulfide, benzene, hydrogen cyanide, hydrogen chloride, phosgene and particulate matter.

Scientists from Texas A&M and Carnegie Mellon are monitoring the chemicals in the area using a mobile lab that they’ve used for the past decade to measure air pollution in real time in cities across the country. They expect to release data from their own tests in East Palestine on Tuesday.

The mobile lab has extremely sensitive equipment that can measure pollution in the parts per trillion. Scientists would then be able to plot them on a graph to show, in real time, where the concentrations of chemicals may be and at what level, Presto said.

Mobile lab workers will try to determine whether there are chemicals in the air that the EPA isn’t monitoring. They are also looking at pollution levels in places where the agency did not set up monitoring stations.

“The situation has to be monitored, and the EPA should continue measurements, and they should also communicate to the general public as to what they’re seeing and put this into context of risk, rather than use the numbers and expect people to figure it out for themselves,” Rusyn said.

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

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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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Saving water can help us deal with the climate crisis. Here’s how to reduce your use | CNN

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The reliability of our faucets providing water every time we turn them on can make water seem like a magical, never-ending resource.

But abusing the availability of this finite resource can contribute to water scarcity and harm our capacity to deal with the impact of the climate crisis.

“Four billion people today already live in places that are affected by water scarcity at least part of the year,” said Rick Hogeboom, executive director of the Water Footprint Network, an international knowledge center based in the Netherlands. “Climate change will have a worsening influence on the demand-supply balance,” he said.

“If all people were to conserve water in some way, that would help ease some of the immediate impacts seen from the climate crisis,” said Shanika Whitehurst, associate director of sustainability for Consumer Reports’ research and testing. Consumer Reports is a nonprofit that helps consumers evaluate goods and services.

“Unfortunately, there has been a great toll taken on our surface and groundwater sources, so conservation efforts would more than likely have to be employed long term for there to be a more substantial effect.”

Yes, businesses and governments should play a part in water conservation by, respectively, producing goods “water efficiently” and allocating water in a sustainable, equitable way, Hogeboom said.

But “addressing the multifaceted water crises is a shared responsibility. No one actor can solve it, nor is there a silver bullet,” he added. “We need all actors to play their part.”

Contrary to what you might think, the water used directly in and around the home makes up a minor portion of the total water footprint of a consumer, Hogeboom said.

“The bulk — typically at least 95% — is indirect water use, water use that is hidden in the products we buy, the clothes we wear and the food we eat,” Hogeboom said. “Cotton, for instance, is a very thirsty crop.”

Of the 300-plus gallons of water the average American family uses every day at home, however, roughly 70% of this use occurs indoors, according to the US Environmental Protection Agency — making the home another important place to start cutting your use.

Here are some ways to reduce your water footprint as you move from room to room and outdoors.

Since the kitchen involves dishwashing, cooking and one of the biggest water guzzlers — your diet — it’s a good place to start.

An old kitchen faucet can release 1 to 3 gallons of water per minute when running at full blast, according to Consumer Reports. Instead of rinsing dishes before putting them in the dishwasher, scrape food into your trash or compost bin. Make sure your dishwasher is fully loaded so you only do as many wash cycles as necessary and make the most use of the water.

With some activities you can save water by not only using less but also upgrading the appliances that deliver the water. Dishwashers certified by Energy Star, the government-backed symbol for energy efficiency, are about 15% more water-efficient than standard models, according to Consumer Reports.

If you do wash dishes by hand, plug up the sink or use a wash basin so you can use a limited amount of water instead of letting the tap run.

If you plan on eating frozen foods, thaw them in the fridge overnight instead of running water over them. For drinking, keep a pitcher of water in the fridge instead of running the faucet until the water’s cool — and if you need to do that to get hot water, collect the cold water and use it to water plants.

Cook foods in as little water as possible, which can also retain flavor, according to the University of Toronto Scarborough’s department of physical and environmental sciences.

When it comes to saving water via what you eat, generally animal products are more water-intensive than plant-based alternatives, Hogeboom said.

“Go vegetarian or even better vegan,” he added. “If you insist on meat, replace red meat by pig or chicken, which has a lower water footprint than beef.”

It takes more than 1,800 gallons of water to produce 1 pound of beef, Consumer Reports’ Whitehurst said.

The bathroom is the largest consumer of indoor water, as the toilet alone can use 27% of household water, according to the EPA. You can cut use here by following this adage: “If it’s yellow, let it mellow. If it’s brown, flush it down.”

“Limiting the amount of toilet flushes — as long as it is urine — is not problematic for hygiene,” Whitehurst said. “However, you do have to watch the amount of toilet paper to avoid clogging your pipes. If there is solid waste or feces, then flush the toilet immediately to avoid unsanitary conditions.”

Older toilets use between 3.5 and 7 gallons of water per flush, but WaterSense-labeled toilets use up to 60% less. WaterSense is a partnership program sponsored by the EPA.

“There’s probably more to gain by having dual flush systems so you don’t waste gallons for small flushes,” Hogeboom said.

By turning off the sink tap when you brush your teeth, shave or wash your face, you can save more than 200 gallons of water monthly, according to the EPA.

Cut water use further by limiting showers to five minutes and eliminating baths. Shower with your partner when you can. Save even more water by turning it off when you’re shampooing, shaving or lathering up, Consumer Reports suggests.

Replacing old sink faucets or showerheads with WaterSense models can save hundreds of gallons of water per year.

Laundry rooms account for nearly a fourth of household water use, according to the EPA. Traditional washing machines can use 50 gallons of water or more per load, but newer energy- and water-conserving machines use less than 27 gallons per load.

You can also cut back by doing full loads (but not overstuffing) and choosing the appropriate water level and soil settings. Doing the latter two can help high-efficiency machines use only the water that’s needed. If you have a high-efficiency machine, use HE detergent or measure out regular detergent, which is more sudsy and, if too much is used, can cause the machine to use more water, according to Consumer Reports.

Nationally, outdoor water use accounts for 30% of household use, according to the EPA. This percentage can be much higher in drier parts of the country and in more water-intensive landscapes, particularly in the West.

If you prefer to have a landscape, reduce your outdoor use by planting only plants appropriate for your climate or ones that are low-water and drought-resistant.

“If maintained properly, climate-appropriate landscaping can use less than one-half the water of a traditional landscape,” the EPA says.

The biggest water consumers outside are automatic irrigation systems, according to the EPA. To use only what’s necessary, adjust irrigation controllers at least once per month to account for weather changes. WaterSense irrigation controllers monitor weather and landscape conditions to water plants only when needed.

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

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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

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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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After a train derailment, Ohio residents are living the plot of a movie they helped make | CNN

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CNN
—

When Ben Ratner’s family signed up in 2021 to be extras in the movie “White Noise,” they thought it would be a fun distraction from their day-to-day life in blue-collar East Palestine, Ohio.

Ratner, 37, is in a traffic jam scene, sitting in a line of cars trying to evacuate after a freight train collided with a tanker truck, triggering an explosion that fills the air with dangerous toxins. In another scene, his father wears a trench coat and hat while people walk across an overpass to get out of town. Directors told the group they wanted them to look “forlorn and downtrodden” as they escape the environmental disaster.

The 2022 movie was shot around Ohio and is based on a novel by Don DeLillo. The book was published in 1985, shortly after a chemical disaster in Bhopal, India, that killed nearly 4,000 people. The book and film follow the fictional Gladney family – a couple and their four kids – as they flee an “airborne toxic event” and then return home and try to resume their normal lives.

Ratner tried to rewatch the movie a few days ago and found that he couldn’t finish it.

“All of a sudden, it hit too close to home,” he said.

Ratner and his family – his wife, Lindsay, and their kids, Lilly, Izzy, Simon and Brodie – are living the fiction they helped bring to the screen.

Officials ordered them to evacuate their home last week, a day after a Norfolk Southern train carrying 20 cars of hazardous materials slid off the rails and caught fire, threatening to explode. The National Transportation Safety Board is still investigating the cause of the incident.

“The first half of the movie is all almost exactly what’s going on here,” Ratner said Wednesday, four days into their evacuation.

In a way, the movie has provided a point of grim humor about the situation facing the residents of East Palestine – the joke no one wanted to make.

“Everybody’s been talking about that,” Ratner said of his friends and neighbors who are keeping in close touch through the crisis. “I actually made a meme where I superimposed my face on the poster and sent it to my friends.”

Scholars who study DeLillo’s work say they are not surprised by the collision of life and art. His work is often described as prescient, said Jesse Kavadlo, an English professor at Maryville University in St. Louis and president of the Don DeLillo Society.

“The terrible spill now is, of course, a coincidence. But it plays in our minds like life imitating art, which was imitating life, and on and on, because, as DeLillo suggests in ‘White Noise’ as well, we have unfortunately become too acquainted with the mediated language and enactment of disaster,” Kavadlo said.

The night of February 3, Ratner was watching his daughter’s basketball game at the local high school when the crash happened. He didn’t hear it over the noise of the game, but when they walked out of the building, he could see the massive blaze. He shot a few seconds of video on his cell phone.

His family returned to their house, which sits less than a mile from the crash site. Throughout the night, he said, they heard sirens but got little information. “We weren’t sure exactly what the danger was.”

While his family slept, he stayed up, nervously watching the fire and the news.

The next morning, activity around the site had picked up. “There was a lot of commotion, helicopters and people hightailing it out of town, and it was it was a little intense,” he said.

His wife and kids headed to stay with his wife’s parents, who live about 2 miles from the crash site. Ratner went to work running the coffee shop he and his wife own, LiB’s Market, in nearby Salem.

By that afternoon, an official alert warned that people needed to move even farther, beyond a 2-mile radius. Roughly half of the town’s 4,800 residents had to evacuate.

A friend offered to let them stay in their pool house. They later moved to another friend’s house next to their café.

School was canceled for the week. They got their dog out of the house, but they had to leave the pet turtle behind.

For now, they’re keeping their distance. But even after they go back, they have to decide whether they’ll stay.

East Palestine is in an economically depressed area, Ratner said, but it had been on a rebound. He and his wife had been considering opening another café there, but now they’re worried that plan is in jeopardy.

“That’s where we’ve been raising our kids, finishing college, buying a business, and that’s been our place,” he said. “In the future, are we going to have to sell the house? Is it worth any money at this point?”

Five of the tankers on the train that overturned last week were carrying liquid vinyl chloride, which is extremely combustible. Last Sunday, they became unstable and threatened to explode. First responders and emergency workers had to vent the tankers, spill the vinyl chloride into a trench, and then burn it off before it turned the train into a bomb. Authorities feared that an explosion could send shrapnel up to a mile away.

But that didn’t happen. The controlled burn worked and the evacuation order for East Palestine residents was officially lifted Wednesday after real-time air and water monitoring did not find any contaminant levels above screening limits.

“All of the readings we’ve been recording in the community have been at normal concentrations, normal backgrounds, which you find in almost any community,” James Justice, a representative of the US Environmental Protection Agency, said at a briefing Wednesday.

Support team members prepared to assess remaining hazards in East Palestine, Ohio, on February 7.

Although authorities have assured the residents that any immediate danger has passed, some residents have yet to return home. Ratner said they’re worried about longer-term risks that environmental officials are only beginning to assess.

Real-time air readings, which use handheld instruments to broadly screen for classes of contaminants like volatile organic compounds, showed that the air quality near the site was within normal limits.

The decision to lift the evacuation order was based on analysis of air monitoring data, according to Charles Rodriguez, community involvement coordinator for the EPA’s Region 5 office.

Up to this point, officials have been looking for large immediate threats: explosions or chemical levels that could make someone acutely ill.

“Under this phase, it’s been the emergency response,” Kurt Kohler of the Ohio EPA’s Office of Emergency Response said Wednesday. “As you see the emergency services go back home, off-site, Ohio EPA is going to remain involved through our other divisions that oversee the long-term cleanup of these kinds of spills.”

The cleanup and monitoring of the site, he said, could take years.

Although the explosion risk is past, Ratner said, people who live in East Palestine want to know about the chemical threats that might linger.

Fish and frogs have died in local streams. People have reported dead chickens and shared photos of dead dogs and foxes on social media. They say they smell chemical odors around town.

When asked at Wednesday’s briefing about exactly what spilled, representatives from Norfolk Southern listed butyl acrylate, vinyl chloride and a small amount of non-hazardous lube oil.

“Butyl acrylate is a lot of what we’re gathering information on,” said Scott Deutsch, a regional manager of hazardous materials at Norfolk Southern.

Butyl acrylate is a clear, colorless liquid with a strong, fruity odor that’s used to make plastics and paint. It’s possible to inhale it, ingest it or absorb it through the skin. It irritates the eyes, skin and lungs and may cause shortness of breath, according to the National Institute of Occupational Safety and Health. Repeated exposure can lead to lung damage.

Vinyl chloride, which is used to make PVC pipes, can cause dizziness, sleepiness and headaches. It has also been linked to an increased risk of cancer in the liver, brain, lungs and blood.

Although butyl acrylate easily mixes with water and will move quickly through the environment, it isn’t especially toxic to humans, said Richard Peltier, an associate professor of environmental health sciences at the University of Massachusetts at Amherst.

“Vinyl chloride, however, has a specific and important risk in that is contains a bunch of chlorine molecules, which can form some really awful combustion byproducts,” Peltier said. “These are often very toxic and often very persistent in the environment.”

Portions of a Norfolk Southern freight train that derailed February 3 were still on fire the next day.

A spokesperson for Norfolk Southern acknowledged but did not respond to CNN’s request for more information on how much of these chemicals spilled into the soil and water.

The Ohio EPA says it’s not sure yet, either.

“Initially, with most environmental spills, it is difficult to determine the exact amount of material that has been released into the air, water, and soil. The assessment phase that will occur after the emergency is over will help to determine that information,” James Lee, media relations manager for the Ohio EPA, wrote in an email to CNN.

Lee said that after his agency has assessed the site, it will work on a remediation plan.

Vinyl chloride is unstable and boils and evaporates at room temperature, giving it a very short lifespan in the environment, said Dana Barr, a professor of environmental health at Emory University’s Rollins School of Public Health.

“If you had a very small amount of vinyl chloride that was present in an area, it would evaporate within minutes to hours at the longest,” she said.

“But the problem they’re facing here is that it’s not just a small amount, and so if they can’t contain what gets into the water or what gets into the soil, they may have this continuous off-gassing of vinyl chloride that has gotten into these areas,” Barr said.

“I probably would be more concerned about the chemicals in the air over the course of the next month.”

State officials said they would continue to monitor the site for exactly that reason. They are also continuing to try to dig and remove contaminated soil.

“Right now, we have a system set up. As the data comes, it is distributed to a network of people to look at both on an immediate-phase – ‘Hey, is there anything really alarming to look at’ – and those smaller numbers that really matter to long-term health,” Kohler said at Wednesday’s briefing.

He said the local health department would test residents’ wells to make sure their drinking water is safe. Officials are also offering to test the air in residents’ homes before they come back.

Norfolk Southern is funding a phone line for residents to speak to a toxicologist with the Center for Toxicology and Environmental Health, an environmental consulting firm.

No one is quite sure whether to trust the help, though, since it’s coming mostly from the company behind the spill. Some residents have already filed a class-action lawsuit against Norfolk Southern.

“We’re definitely signing up for the air testing of the home before we get in there,” Ratner said.

The first trains to pass since the accident started rolling through again midweek, Ratner said. The roar of the trains, a sound he used to tune out, is now jarring.

Even the sounds of loud trucks are “off-putting,” he said.

Don Cheadle, left, and Adam Driver star in

Ratner said it was fun to be part of a disaster movie – a stylized, darkly comedic Netflix streamer starring Adam Driver, Greta Gerwig and Don Cheadle.

In real life, the situation has been gutting.

“Those are great actors, but it was hard to see it as a put-on,” Ratner said.

He shares the sentiments of Lenny Glavan, a local tattoo artist, who wrote a letter to Norfolk Southern CEO Alan Shaw on Tuesday to express the town’s anger and frustration over the accident.

“You just ripped from us our small-town motto ‘A place you want to be,’ ” Glavan wrote.

“It may not be beach-front property, it may not even have the highest paying jobs, or much else to offer, but in my experiences in life, the place I and most people want to be is when you need a helping hand, a shoulder to cry on, a friend to pray with, or a place to call home East Palestine has always been that place to want to be,” he said in his note, which was publicly posted on Facebook.

“With the events in which have occurred, the railroad that gave this small town life has now taken the life, the heartbeat, the unity and that security that families or individuals long for in this wild world away … possibly indefinitely.”

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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

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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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Proposed changes to school lunches aim to reduce sugar and sodium, but flavored milk stays | CNN

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CNN
—

If new US Department of Agriculture school food guidelines stand as proposed, chocolate milk is in, but for the first time ever, at least some added sugars will be out – and sodium levels will be reduced gradually.

Agriculture Secretary Tom Vilsack publicly announced the changes on Friday.

“The purpose of this is to improve the health and welfare of our children. And I think everybody who comes to this issue shares that goal and hopefully, collectively, we can make sure it happens,” Vilsack told CNN in an interview Thursday ahead of the announcement.

The federally assisted school meal program provides nutritionally balanced meals at school at low or no-cost.

More than 15.3 million kids every day get breakfast at school in the US and 29.6 million get a school lunch, Vilsack said. The numbers were higher earlier in the pandemic, when meals were offered free to all children regardless of their family’s income, but in June, Congress did not extend the Covid-19 pandemic waivers that had expanded the program.

While school meals are paid for by local and federal funding, the standards for what goes on a kids’ cafeteria tray are set by the USDA. The agency’s job is to make sure any meal served at school is nutritious and falls in line with the US Dietary Guidelines.

Flavored milk with “reasonable limits on added sugars” would be allowed under the proposal. Vilsack said school meal administrators tell the USDA that kids just won’t drink much no-fat skim milk or unflavored milk. “That’s not what they get at home,” Vilsack said. “We want to encourage kids to drink milk because there are there’s tremendous nutritional value in milk.”

However, the proposed standards would limit added sugar in certain high-sugar products like prepackaged muffins, yogurt, and cereal. Eventually, the guidelines would then limit added sugars across the weekly menu.

The standards would reduce sodium limits, but that would happen gradually over several school years.

“The [US Food and Drug Administration] provided some insight and direction by suggesting that it is easier for people to accept and adopt to reduced sodium if you do it over a period of time in small increments,” Vilsack said.

A gradual reduction would also give industry time to reformulate their products, said Dr. Lauren Au, an assistant professor at UC Davis’ Department of Nutrition who studies the effectiveness of school nutrition programs.

The guidelines would also place a bigger emphasis on whole grains, but still leave options open for an occasional non-whole grain product.

“Maybe a biscuit can be instituted for a little variety, or grits can be provided where that may make sense from a geographic standpoint. You are sensitive to cultural demands and needs,” Vilsack said.

The proposed rule would also strengthen the Buy American requirements encouraging schools to use more locally grown food.

The USDA will invest $100 million in the Healthy Meals Incentives initiative which offers farm-to-school grants and grants to buy equipment. In the 1980s, schools around the country tore out kitchens and bought prepackaged processed food. To make more nutritious meals, schools have had to rebuild or update kitchens.

“A lot of schools have outdated ovens, freezers, fridges, and that puts limitations on how they can prepare food, so grants that have helped with equipment have been really successful,” Au said.

The money would also reward schools that do a good job providing nutritious meals. Grants would also be aimed at small and rural districts and training.

Vilsack said the USDA created these proposed standards after the USDA received thousands of comments and held 50 listening sessions with parents, school food administrators, the food industry, public health and nutrition experts.

“Establishing these standards are difficult because you have to follow the science you have to follow the dietary guidelines, but you also have to understand that they need to be implemented in the real world which is which is which is tough,” Vilsack said in an interview with CNN.

Real world circumstances are tough already with the higher cost of food, staff shortages and supply chain problems.

Au hasn’t seen all of the proposed policies, but she said what she has seen look good.

“It’s a step forward in terms of promoting healthy nutrition in schools,” Au said. The reduction of added sugar, she added is a big deal.

“Reducing added sugars for this age range is so important,” AU said.

Megan Lott, deputy director for the Robert Wood Johnson Foundation program Healthy Eating Research, said that the policies seem to be heading in the right direction.

“There are a couple of things we would probably like to see strengthened, but it also seems like there are plans to do that over time,” Lott said.

The sugar standard is a good start, she said, but she’d prefer the proposal instead say that no more than 10% of calories should come from added sugars across the meal plan.

“But we recognize that schools might need a little bit of time for implementation,” Lott said.

Lott had also hoped they would take flavored milk off the menu. Research shows that schools that have gotten rid of flavored milk show a drop in milk consumption for a year or two, but milk sales eventually rebound.

School food has become a proverbial hot potato.

After decades of bipartisan support for school meals, the program has been politicized in about the last 10 years Lott says, meaning there is bound to be some pushback.

Friday’s proposed changes would be the first large scale reform of school meal standards since President Barack Obama signed the 2010 Healthy, Hunger-Free Kids Act into law.

The law that went into effect in 2012, championed by first lady Michelle Obama, really did improve US kids’ diet, studies show. The law raised the minimum standards and required schools to serve more whole grains, fruit, vegetables, and fat-free and/or low-fat milk more frequently and serve fewer starchy vegetables and foods high in trans fat and sodium.

Meals that were eaten by students – not just served to students and then tossed into garbage cans – were much healthier and had better overall nutritional quality, the study showed. Students who didn’t participate in the national program did not see an improvement in their diets.

Despite the program’s success, in 2018, the Trump administration announced a proposal to roll back many of the policies in the name of “flexibility,” including ones that involved sodium and whole grains. Trump’s policy would essentially create a loophole letting schools sell more burgers, pizza and french fries and reduce the fruit and vegetables sold. A federal court struck down the rule in April 2020.

During the pandemic, some of the polices were relaxed, like for whole grains, because it was difficult to find products, Lott said.

Studies show kids who eat meals at school ate more fruits, vegetables, whole grains and dairy, compared with those who ate at school less frequently.

Better nutrition can help prevent obesity. About 20% of the US population ages 2 to 19 live with obesity, which can cause kids to have high blood pressure, breathing problems and type 2 diabetes, and lead to lifelong health problems, according to the US Centers for Disease Control and Prevention.

Hungry kids have a hard time paying attention in class. Students who ate healthy meals at school scored better on end-of-year academic tests, studies have shown.

The new standards are just a proposal. The USDA will ask for additional feedback.

Vilsack is hopeful the standards will incentivize more schools to offer more healthy options.

“In terms of future of this program,” Vilsack said, “we want to see more and more school districts push themselves not only to meet the standards, but in some cases to exceed them.”

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Tag: government organizations – us

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