Tag: brand safety-nsf drugs negative

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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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.”

In the 2022 film

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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Climate change is contributing to the rise of superbugs, new UN report says | CNN

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CNN
 — 

Climate change and antimicrobial resistance are two of the greatest threats to global health, according to a new report from the United Nations Environment Programme.

The report, titled “Bracing for Superbugs,” highlights the role of climate change and other environmental factors contributing to the rise of antimicrobial resistance. It was announced Tuesday at the Sixth Meeting of the Global Leaders Group on Antimicrobial Resistance in Barbados.

Antimicrobial resistance or AMR happens when germs such as bacteria, viruses and fungi develop the ability to defeat the medications designed to kill them.

“The development and spread of AMR means that antimicrobials used to prevent and treat infections in humans, animals and plants might turn ineffective, with modern medicine no longer able to treat even mild infections,” the UN Environment Programme said in a news release.

Roughly 5 million deaths worldwide were associated with antimicrobial resistance in 2019, and the annual toll is expected to increase to 10 million by 2050 if steps aren’t taken to stop the spread of antimicrobial resistance, according to the report.

In the US, there are nearly 3 million antimicrobial-resistant infections each year, and more than 35,000 people die as a result, the US Centers for Disease Control and Prevention says.

Antimicrobials are commonly used in cleaning products, plant pesticides and medications to kill and prevent the spread of germs among people, animals and crops.

Drug resistance can develop naturally, but experts say the overuse of antimicrobials in people, animals and food production has accelerated the process. The microorganisms that survive these chemicals are stronger and more powerful, and they can spread their drug-resistant genes to germs that have never been exposed to antimicrobials.

The focus so far has largely been on excessive antimicrobial use, but experts say there is growing evidence that environmental factors play a significant role in the development, transmission and spread of antimicrobial resistance.

“Climate change, pollution, changes in our weather patterns, more rainfall, more closely packed, dense cities and urban areas – all of this facilitates the spread of antibiotic resistance. And I am certain that this is only going to go up with time unless we take relatively drastic measures to curb this,” said Dr. Scott Roberts, an infectious diseases specialist at Yale School of Medicine, who was not involved with the new UN report.

The climate crisis worsens antimicrobial resistance in several ways. Research has shown that increased temperatures increase both the rate of bacterial growth and the rate of the spread of antibiotic-resistant genes between microorganisms.

“As we get a more extreme climate, especially as it warms, the gradients that drive the evolution of resistance will actually accelerate. So, by curbing temperature rises and reducing the extremity of events, we can actually then fundamentally curb the probability of evolving new resistance,” Dr. David Graham, a professor of ecosystems engineering at Newcastle University and one of the UN report’s authors, said at a news conference ahead of the report’s release.

Experts also say severe flooding as a result of climate change can lead to conditions of overcrowding, poor sanitation and increased pollution, which are known to increase infection rates and antimicrobial resistance as human waste, heavy metals and other pollutants in water create favorable conditions for bugs to develop resistance.

“The same drivers that cause environmental degradation are worsening the antimicrobial resistance problem. The impacts of antimicrobial resistance could destroy our health and food systems,” Inger Andersen, the UN Environment Programme’s executive director, said at the news conference.

Environmental pressures are creating bugs that thrive in the human body, which experts say is unusual for some species.

“There’s one hypothesis from a prominent mycologist who suggests that the reason the body’s temperature is 98.6 is because that is the temperature where fungi can’t grow that well. And so, now we’re seeing Candida auris and some of the other new microbes that have come up that really grow quite well – even at temperatures of 98.6 in the human body. And so I think climate change, really selecting for these organisms to adapt to a warmer climate, is going to increase the odds that there’s infection in humans,” Roberts said.

Such opportunistic infections jeopardize medical advancements like joint replacements, organ transplants and chemotherapy – procedures in which patients have a significant risk of infection and require effective antibiotics.

Drug-resistant infections can make treatment difficult or even impossible. Roberts says that resorting to “last-ditch treatments” is “never a good scenario from the patient level because there are reasons we don’t use them up front,” such as organ toxicity and failure.

“When somebody does present with a drug-resistant bacteria or fungus and we really need to rely on one of these last-line antibiotics, it’s usually a challenge to treat from the outset. And so the patients really don’t do as well as a result,” he said. “In rare circumstances, we run out of options entirely, and in that case, there’s really nothing we can do. Fortunately, those cases remain quite rare, but I am certain that with this growing antibiotic resistance problem, we’ll see these increasing frequency over time.”

Experts say that both climate change and antimicrobial resistance have been worsened by and can be improved by human actions. One critical step is to limit antibiotic overuse and misuse.

“Antibiotics and antifungals do not work on viruses, such as colds and the flu. These drugs save lives. But, anytime they are used, they can lead to side effects and antimicrobial resistance,” the UN report’s authors wrote.

The authors also emphasize that the health of people, animals, plants and the environment are closely linked and interdependent, and they call on governments to identify policies to limit antibiotic use in agriculture and reduce environmental pollution.

Finally, experts say, steps to reduce climate change are steps to limit antimicrobial resistance.

“Whatever we can do on an individual level to kind of reduce the impact of climate change, really, that’s kind of only worsening this problem, as well as pollution and urbanization and in dense, crowded areas. Although I know from the individual level that’s a hard thing to change,” Roberts said.

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Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

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Watch CNN Films’ “American Pain” at 9 p.m. ET Sunday, February 5.



CNN
 — 

Sitting among the warehouses of Dulles, Virginia, is one of the US Drug Enforcement Administration’s forensic labs. It’s one of eight across the country where scientists analyze illegal drugs and try to stay ahead of what’s driving deadly overdoses.

Starting in the late 1990s with overprescribing of prescription narcotics, the opioid epidemic has continued to plague the United States for decades. What has changed is the type of drugs that have killed more than half a million people during the past 20 years.

CNN was granted rare access to the secret lab where the DEA tests seized illicit drugs to understand what’s coming next.

“The market is constantly changing, so we are trying to do everything we can from a science base to keep up with that,” Scott Oulton, deputy assistant administrator of the DEA’s Office of Forensic Sciences, told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

Holding a white bag of fentanyl precursor powder – one of the chemicals used to make the opioid – Oulton explained that the illicitly made painkiller continues to be a dominant presence in the drugs officials are finding.

“This kilogram can be converted into fentanyl to make approximately 800 grams,” he said. “So it doesn’t take that much material, it’s fairly cheap, it’s inexpensive to obtain.”

Fentanyl is the deadliest drug in the United States, and it’s often found in combination with other illicit drugs, including cocaine and heroin. But increasingly, fentanyl is showing up in illicit pills disguised as common prescription drugs like oxycodone, hydrocodone, even Adderall.

Users buying drugs on the street that look like prescription pills may end up with a highly potent, potentially deadly drug they never intended to take.

“Over 99% of what we see are fake. They contain fentanyl,” Oulton says of the pills that the agency is seizing.

The 800 grams of fentanyl that Oulton held could be turned into 400,000 to 500,000 potentially lethal pills.

As more and more of these lethal pills circulate, the opioid epidemic is reaching more of the population.

Deena Loudon of Olney, Maryland, is among those living with its effects.

“I truly love sharing Matthew with the world,” Loudon says as she flips through pictures of her son.

One of her favorite memories is Matthew playing hockey – what Loudon calls his happy place.

Matthew Loudon's mom says he turned to drugs after struggling with anxiety.

But she also recalls his struggles with anxiety, which led him to turn to drugs. He started dabbling in them in the 10th grade. By the following year, his grades began to fall, and he couldn’t keep them high enough to stay in hockey.

“He was using Xanax to help self-medicate himself and I think to help get rid of some of that angst so he could live somewhat of a normal life,” Loudon said.

Matthew was always honest, almost to a fault, Loudon says. “He told me he tried everything. Like everything. Heroin, meth, crack, you name it, cocaine, whatever – until I guess he found what made him feel the best, and it was Xanax.”

And as much as a mother can worry, Loudon says, Matthew always tried to reassure her. “I know what I’m doing,” he would tell her.

She had heard about fentanyl showing up in pills in their area.

“But you don’t ever think it’s going to happen to you,” Loudon said.

She said they even had a conversation about fentanyl the day before he died. “I was sort of naive, wanting to stick my head in the sand and thinking ‘I bet he does know what he’s doing.’ ”

On November 3, 2020, she found 21-year-old Matthew on the floor of their basement.

Matthew’s autopsy report lists his cause of death as fentanyl and despropionyl fentanyl intoxication.

“I don’t say he overdosed. I say he died from fentanyl poisoning. … Truthfully, like, at the end of the day, to me, he was murdered, right? Because he asked for one thing. They gave him something different. And it took his life.”

For a parent, she said, the hardest thing is burying their child. It’s a pain she speaks out about in hopes of keeping other families safe.

“It’s Russian roulette,” she warns them. “You never know what you’re gonna get.”

The number of pills the DEA has seized skyrocketed in just three years, from 2.2 million in 2019 to 50.6 million in 2022.

The sheer volume of pills has been one of the biggest challenges for the DEA’s lab, Oulton says. As the fentanyl threat continues to grow, the Virginia facility is expanding to accommodate the analysis needed.

The lab can test for something as simple as the presence of fentanyl, but something called the purity of the pill also offers important insight. This means how much fentanyl is actually in one of these illicit pills.

“Lately, we’ve been seeing a purity increase over the last year, where we used to say roughly four out of the 10 seizures that we were receiving would contain a lethal dose of greater than 2 milligrams. As of October last year, we started reporting that we’ve seen an uptick. Now we’re saying that six out of 10 of the seizures that we’re receiving contain over 2 milligrams,” Oulton said.

He says they’re finding an average of 2.3 milligrams of fentanyl in each pill.

Two milligrams may be the cutoff for what is considered lethal, but Oulton says that doesn’t necessarily mean a pill with 1.99 milligrams of fentanyl can’t be deadly.

“One pill can kill” is his warning.

“The message I would like to send out is, don’t take it,” he said. “Don’t take the chance. It’s not worth your life.”

Oulton says he and his team are constantly finding new and different drugs and substances in pills – things they’ve never seen before.

One machine in the lab is almost the equivalent of an MRI in a medical office, showing the structure and detail of a pill.

“We will do what we call structural elucidation to determine that this is a different version of a fentanyl that’s got a new compound and molecule that’s been added to it,” Oulton said.

They’ve seen “hundreds and hundreds of unique combinations,” he said.

“We’ll see one that contains fentanyl, one with fentanyl and xylazine, one with fentanyl and caffeine, one with fentanyl and acetaminophen, and you don’t know what you’re getting.”

Xylazine, a veterinary tranquilizer, poses a unique problem. It’s not an opioid, so even when it’s mixed with fentanyl, drugs designed to reverse an opioid overdose may not work.

Narcan or naloxone, one of the more common overdose-reversing drugs, has become increasingly necessary as the prevalence and potency of illicit drugs increases. About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Oulton wants to be clear: The problem Isn’t with pills prescribed by your doctor and dispensed by a pharmacy – it’s the pills on the illicit market.

Those, Matthew’s mother warns, are easy to get.

“The first pills [Matthew] got was in high school. And it was just flipping out, floating around, and it was easy for him to get his hands on,” she said.

Loudon’s message for parents now: Keep your eyes open.

“Just be mindful of what your children are doing. You just just have to keep your eyes open. And even sometimes, when you keep your eyes open, you can miss some of the warning signs, but I think a parent knows their child best, so just keep talking.”

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Report shares new details about death possibly linked to experimental Alzheimer’s drug | CNN

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CNN
 — 

The death of a participant in a clinical trial of an antibody treatment for Alzheimer’s disease, which is now under consideration by the US Food and Drug Administration, may be linked to the experimental drug, a new report shows.

The research letter, published Wednesday in the New England Journal of Medicine, shares details about what happened to the participant in the open-label extension phase of the trial of lecanemab.

In an open-label extension, there is no placebo arm; rather, all the participants get the medication in question because an earlier part of the trial has shown so much potential.

In this case, a 65-year-old who was in the early stages of Alzheimer’s was taken to an emergency room in a Chicago-area hospital within 30 minutes of the first signs of a stroke, the report says. Doctors at the Northwestern University Feinberg School of Medicine learned that the patient had gotten infusions of lecanemab four days before.

This patient is not the only one to die during the open-arm extension. The health publication Stat reported that an investigator told it about the death of another participant who had bleeding in the brain that may have been related to the drug. In that case, drugmaker Eisai pointed to other possible factors.

Lecanemab is meant to slow the progression of Alzheimer’s. In November, the company released a study showing that it slowed the progression of cognitive decline by 27% compared with a placebo. It also reduced amyloid levels – a protein that is one of the hallmarks of Alzheimer’s – and had positive effects on cognition and the ability to perform everyday tasks when compared with a placebo.

The research also showed that about 2.8% of trial participants who took the drug had a symptomatic side effect called ARIA-E, which involves swelling in the brain. None of the participants who got a placebo had that.

The new report says the medical team at the hospital gave the patient a common medication to break up blood clots that could cause a stroke, called t-PA bolus. Nothing in the patient’s medical background suggested that they would have a problem with that drug. But less than an hour into the treatment, their blood pressure shot up, so doctors stopped the infusion.

A CT scan showed extensive bleeding in the brain.

The doctors then administered a medicine that can control the bleeding, but the patient became severely agitated and developed communication problems. The patient also had frequent nonconvulsive seizures.

The medical team was able to treat the seizures, but the person’s condition did not get better.

After three days in the hospital, the person got a tube in their windpipe to help them breathe. Even with that and other supportive care, the patient died.

An autopsy showed that the patient had extensive brain bleeding and amyloid deposits within many of the blood vessels in their brain that probably contributed to the hemorrhage, the report said.

Essentially, the report says, the blood vessels in the patient’s brain must have burst after being exposed to the blood clot medicine t-PA.

“The extensive number and variation in sizes of the cerebral hemorrhages in this patient would be unusual as a complication of t-PA solely related to cerebrovascular amyloid,” the report says. But the combination of the clot-busting drug with lecanemab may have led to the cerebral hemorrhages.

Northwestern Medicine declined CNN’s request to interview the authors of the new report but said in a statement that it was “an effort to provide relevant data to the medical and scientific community.”

Eisai said it did not have an official response because of patient privacy.

The company and Northwestern Medicine pointed to a response published alongside the new report from clinicians and researchers who were involved in the lecanemab clinical trials.

Drs. Marwan Sabbagh and Christopher H. van Dyck wrote in that response that they “agree that this case raises important management issues for patients with Alzheimer’s disease.”

It is an “unusual case, and we understand why the authors want to highlight a potential concern,” they said.

Their response also pointed to other potential factors in the deaths of both trial participants.

In this case, the brain bleed could have been connected to a period of time after the stroke when the patient’s blood pressure was exceptionally high, they said. And the other trial participant was taking a drug for atrial fibrillation that may have been a contributing factor.

The doctors also write in the response that other patients who have gotten t-PA have died with these amyloid deposits within blood vessels in the brain.

Dr. Sharon Cohen, a behavioral neurologist who works with Alzheimer’s patients at the Toronto Memory Program and an investigator in the lecanemab trial, says it’s been difficult to develop a therapeutic for Alzheimer’s.

Cohen said that doctors have known for years that almost all of the drugs in this class can come with a side effect of ARIA, which stands for amyloid-related imaging abnormalities.

The safety of the drug “looks very acceptable,” she said. “It’s within the range of adverse events that we expected and seems very reasonable for this patient population.”

The rate of bleeding in the trial is considered very low, and most of the microbleeds seen in the trial have been asymptomatic, she said.

In the case of the patient in the new report, Cohen thinks the death was probably related to the blood clot drug but said the combination of that drug and lecanemab “gives us pause.”

If the FDA approves the treatment, there may be some discretion in terms of patient choice and what the prescribing physician feels is best for for someone who is taking anticoagulants or has other risk factors for hemorrhaging, she said.

In general, lecanemab has in many ways exceeded our expectations, she said, “because we haven’t seen such consistently positive results in an Alzheimer’s disease modification trial at all until now.”

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Pandemic fueled alcohol abuse, especially among women, but there are treatment options | CNN

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Editor’s Note: In the final two episodes of “This Is Life With Lisa Ling,” the series explores alcoholism in America (at 9 p.m. ET Sunday) and interracial marriages (at 10 p.m. ET Sunday).



CNN
 — 

Brook was 34 years old when her use of alcohol escalated, a way of coping with a breast cancer diagnosis.

“I just decided I’m not gonna go through this straight,” she told Lisa Lang in an episode of “This Is Life With Lisa Ling,” airing at 9 p.m. ET Sunday on CNN.

“I would drink before I went to my chemo sessions. It became more and more of a coping mechanism,” said Brook, who did not want to use her last name.

Brook survived the bout with cancer but says she became dependent on alcohol — and the pandemic only made it worse.

“When Covid started and I was home, I started drinking more and more and more,” said Brook, now 42. “I started not being able to eat, I started throwing up more often, and then I started throwing up blood.”

She recently ended up in the hospital, diagnosed with cirrhosis of the liver and a bad bleed from ulcers, which doctors said could take her life if not quickly treated.

“When they were talking to me afterwards, they said, ‘If you keep going like this, you’ll be dead in a year,’ ” Brook told Ling.

Alcohol use disorder is defined as compulsively using alcohol despite negative consequences on relationships and one’s ability to function at work, school or in the community. Over time, excessive alcohol use may even rewire the brain, making booze as desirable as natural rewards such as food or sex, experts say.

Researchers at University of California, Los Angeles showed pictures of alcoholic drinks to people who are and are not addicted while scanning their brains. Regions of the brain associated with craving, pleasure and reward lit up significantly more in those with an alcohol use disorder.

“It’s much more of a medical and brain disease than we initially thought,” Lara Ray, a clinical psychologist who runs the UCLA Addictions Lab, told Ling.

In addition, just one pint of beer or average glass of wine a day may begin to shrink the overall volume of the brain. The brains of nondrinkers who began consuming an average of one alcohol unit a day showed the equivalent of half a year of aging, according to a study published in March.

The damage worsens as the number of daily drinks rises, the study found — drinking four alcohol units a day aged a person’s brain by more than 10 years.

Alcohol use disorder is a growing problem in the United States, which experts say has been enhanced by the pandemic, especially among women.

“Last year, I took care of two women who were in their early 20s who had cirrhosis and needed liver transplants, and I’ve never seen that before in my entire career,” Dr. James Burton, medical director of liver transplantation at the University of Colorado School of Medicine in Aurora, told Ling.

A recent study found a significant increase in alcohol-associated liver disease and a 15% higher rate of waiting lists and subsequent liver transplants between 2020 and 2021 — the greatest increase occurred in young adults.

Since the pandemic’s onset, statistics show an overall 14% increase in the number of drinking days per month, but a “41% increase in heavy drinking days among women,” Dr. Sarah Wakeman, medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital, told CNN in January.

Why? Pre-pandemic mom wine culture, which “normalized and even glorified” drinking, is partly to blame, said Dr. Leena Mittal, chief of the women’s mental health division in the department of psychiatry at Brigham and Women’s Hospital in Boston.

In addition, “studies have shown the complexities of balancing home, work and caregiving responsibilities during the pandemic have fallen disproportionately on women,” Mittal said earlier.

Women are especially sensitive to the effects of alcohol, according to the National Institute on Alcohol Abuse and Alcoholism. Alcohol-related problems appear sooner and at lower drinking levels than in men, said the institute, part of the US National Institutes of Health.

Women are more susceptible to alcohol-related brain damage and heart disease than men, and studies show women who have one drink a day increase their risk of breast cancer by 5% to 9% compared with those who abstain.

Pandemic lockdowns also forced many people to live and work from home — sometimes alone. A July study found drinking alone during adolescence and young adulthood can strongly increase the risk for alcohol abuse later in life, especially if you are a woman.

Victoria, who also did not want to use her last name, told Ling she began drinking as a teenager. Now 55, she still “can’t control it. It’s like a tension that builds up. And so then when I do drink, it’s like, ‘Ah! I’m drinking,’ you know, so it’s way too much, way too fast.”

Victoria says she continues to crave alcohol but goes regularly to support meetings for addiction recovery after moving in with her mother during the pandemic.

Binge drinking — defined as more than four drinks for women and five for men within a few hours — is on the rise. According to a study published in June, even older people who consider themselves moderate users of alcohol are downing multiple drinks in one sitting.

People who binged were about five times more likely to experience numerous alcohol problems, including injuries, emotional or psychological issues, and alcohol dependence at work or school or while caring for children, the study found.

“What this means is that an individual whose total consumption is seven drinks on Saturday night presents a greater risk profile than someone whose total consumption is a daily drink with dinner, even though their average drinking level is the same,” study coauthor Charles Holahan, professor of psychology at the University of Texas at Austin, told CNN previously.

The US Food and Drug Administration has approved only three drugs designed to reduce alcohol use since 1951: disulfiram, which causes headaches, nausea and vomiting when mixed with alcohol; acamprosate, which works on the reward centers of the brain to reduce alcohol cravings; and naltrexone, which reduces cravings and appears to help with heavy drinking.

There is help. Find it here

  • The National Institute on Alcohol Abuse and Alcoholism has a tool called the NIAA Alcohol Treatment Navigator that “helps adults find alcohol treatment for themselves or an adult loved one.” For teens, the institute recommends these resources.
  • The Substance Abuse and Mental Health Services Administration has a free, confidential National Helpline active 24/7/ 365 days a year to provide information and treatment referrals to local treatment facilities, support groups and community-based organizations: 800-662-HELP (4357) and 800-487-4889 (TTY option).

    • All three have significant side effects that can deter people from using them consistently.

    Researchers continue to experiment with various drugs to see if they can help cure cravings without major side effects. While not FDA-approved, the anticonvulsant drug topiramate has shown promise in some clinical trials but may affect cognition and memory. Other anticonvulsant drugs, such as zonisamide and gabapentin, and a smoking cessation drug called varenicline have shown mixed results.

    At Ray’s lab at UCLA, small clinical trials have found promising results from the neuromodulator ibudilast, which hindered cravings and reduced the odds of heavy drinking for some people by 45%.

    For Billy Flores, 45, the change happened quickly.

    “In the first two days, I was upset in the stomach, but by the third day I was on it, I was off of alcohol, which is pretty amazing I thought,” he told Ling about using ibudilast.

    Bill has struggled with alcohol but says he has found hope with a clinical trial.

    Additional studies are needed to see if the benefits hold true for larger populations.

    In the meantime, there are gold standard treatments for alcohol use disorder that don’t involve medications. Those include Alcoholics Anonymous and Self-Management and Recovery Training 12-step programs, cognitive behavioral treatments and mindfulness-based approaches.

    A large 2006 clinical trial found behavioral interventions can be as effective as drugs — in fact, most of the medication clinical trials done to date have also included some form of social or behavioral treatment in combination with drugs.

    Having support is critical to keeping a positive mindset that will ultimately win the battle with alcohol, experts say.

    Brook agrees.

    “When I was doing my therapy intake for rehab, one of the questions was, ‘What made you decide to do this?’ And I said, ‘I’m better than this,’ ” she told Ling.

    “I still like to think that even with the relapses, I’m gonna still be that person who gets right back up and tries again.”

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