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



CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



CNN
 — 

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

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

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

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

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

Novartis resumed production at both plants in June.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Ozempic prescriptions can be easy to get online. Its popularity for weight loss is hurting those who need it most | CNN



CNN
 — 

Telehealth and social media are playing a significant role in driving demand for Ozempic, a prescription drug that treats Type 2 diabetes, experts told CNN. The current drug shortage has limited access for patients with diabetes who rely on it to control their blood sugar.

Digital health companies make medications like Ozempic easier to get by providing prescriptions online. Many advertise quick and easy — sometimes same-day — access.

“Anecdotally, it’s almost easier to get medication [via digital health companies],” said Dr. Disha Narang, endocrinologist and director of obesity medicine at Northwestern Medicine, Lake Forest Hospital. “But not always the safest.” People who put in average weights on the online intake forms were still offered the antidiabetic drug, Narang told CNN.

In part because of Ozempic’s popularity, the prescription weight loss drug market has grown significantly, according to MarketData Enterprises, an independent market research and consulting firm. The market surpassed forecasters’ expectations for 2022 and is expected to become a nearly $2 billion industry in 2023.

WeightWatchers is also tapping into the telehealth prescription drug space. Last week, the company bought telehealth subscription service Sequence, which helps connect patients to doctors who can prescribe weight loss and diabetes drugs.

“At the start of 2022, these companies weren’t marketing this stuff,” Narang said, noting advertising around Ozempic took off in 2022. “I think we really need to start questioning our ethics around this.”

There are few across-the-board requirements when it comes to digital health companies’ intake processes, Dr. Bree Holtz, an associate professor at Michigan State University studying telemedicine, told CNN. Once a patient fills out the required forms online, information gets transferred to an in-state provider who can write the prescription. Some companies require that the patient hop on a video or phone call with the provider — others don’t require either.

“It’s a little scary that you can just wake up and get these appointments in — or these pharmaceuticals — and you’re not being cared for,” said Holtz.

Telehealth has been a game changer in providing access to health care, particularly during the pandemic. And especially for people living in places where high-quality primary care is not available, direct to consumer telehealth services can help fill a gap, said Dr. Laurie Buis, associate professor in the Department of Family Medicine at the University of Michigan, whose research focuses on digital health.

When patients begin to seek selective treatment from selective providers, however, Buis says it opens the door to problems like fragmented care or abuse. Telehealth providers may not have access to a patient’s full medical history and may be less able to provide holistic care that a primary care physician otherwise could.

“I have no doubt that some of these services are doing a good job,” said Buis. “There are also services that don’t take it quite as seriously. And that’s of concern.”

The US Food and Drug Administration first announced that Ozempic was in shortage last August. Supply will likely be strained through mid-March, according to the FDA drug shortages database.

Ozempic prescriptions in the US reached an all-time high in the last week of February, with over 373,000 prescriptions filled, according to a J.P. Morgan analysis of IQVIA data shared with CNN. That’s an increase of 111%, compared with the same week in 2022.

Of these, more than half were new prescriptions, according to a CNN review of J.P. Morgan’s analysis.​​

With many patients relying on Ozempic for diabetes treatment, providers like Narang are scrambling to figure out what alternatives to put their patients on.

“We’re getting messages daily about patients not being able to get their own medication,” Narang said. “It’s been tough for patients and providers alike.”

Ozempic currently holds more than 40% of the US market share of glucagon-like peptide 1 (GLP-1) agonists — a class of drugs that mimic an appetite-regulating hormone — according to analysis from J.P. Morgan. These drugs work by stimulating the release of insulin, which helps lower blood sugar. They also slow the passage of food through the gut.

Ozempic has grown quickly in popularity since it was first put on the market in 2018. The drug has safely and successfully been used to help diabetics improve blood sugar levels and put diabetes into remission, Narang told CNN. Ozempic is the most potent of all the GLP-1 medications, she said.

Behind the brand name Ozempic is the medication semaglutide. While Ozempic is used primarily to treat Type 2 diabetes, another drug by the name Wegovy — also semaglutide — is approved specifically for chronic weight management.

Although approved by the FDA in 2021, Wegovy was not readily available through most of last year, according to Narang, so people turned to Ozempic. According to the FDA drug shortages database, Wegovy was undersupplied starting at the end of last March but came back in stock earlier this year.

Social media buzz around the two drugs took off at the start of 2023. Celebrities shared their testimonies about how semaglutide helped them shed unwanted pounds. Elon Musk, for example, publicly credited Ozempic and Wegovy in part for his weight loss.

#Ozempic and #Wegovy have been “extremely popular” over the last few months on TikTok, according to company analytics.

The use of Ozempic and Wegovy for short-term weight loss has resulted in real consequences for patients who need the drugs most for diabetes treatment and chronic weight management, said Narang. For example, some insurance companies in the past have reportedly refused to cover Wegovy, one calling it a “vanity drug.”

Both drugs are intended for long-term use, not for short-term weight loss. Their appetite-regulating effects wear off quickly after you stop taking them.

“This is not meant to be a medication to take off your last five or 10 pounds to get ready for an event or something like that. It’s not for use of three or four weeks,” Narang said. “When we think about weight management, we’re thinking about the next 25 years of someone’s life.”



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Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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



CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The BCG shortage is expected to continue for years.

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



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



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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New boosters add limited protection against Covid-19 illness, first real-world study shows | CNN





CNN
 — 

Updated Covid-19 boosters that carry instructions to arm the body against currently circulating Omicron subvariants offer some protection against infections, according to the first study to look at how the boosters are performing in the real world. However, the protection is not as high as that provided by the original vaccine against earlier coronavirus variants, the researchers say.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the new data “really quite good.”

“Please, for your own safety, for that of your family, get your updated Covid-19 shot as soon as you’re eligible to protect yourself, your family and your community,” Fauci said at a White House briefing Tuesday.

Uptake of the bivalent boosters, which protect against the BA.4/5 subvariants as well as the original virus strain, has been remarkably slow. Only 11% of eligible Americans have gotten them since they became available in early September.

The new study found that the updated boosters work about like the original boosters. They protect against symptomatic infection in the range of 40% to 60%, meaning that even when vaccine protection is its most potent, about a month after getting the shot, people may still be vulnerable to breakthrough infections.

That’s in about the same range as typical efficacy for flu vaccines. Over the past 10 years, CDC data shows, the effectiveness of the seasonal flu vaccines has ranged from a low of 19% to a high of around 52% against needing to see a doctor because of the flu. The effectiveness varies depending on how similar the strains in the vaccine are to the strains that end up making people sick.

The authors of the new study say people should realize that the Covid-19 vaccines are no longer more than 90% protective against symptomatic infections, as they were when they were first introduced in 2020.

“Unfortunately, the 90% to 100% protection was what we saw during like pre-Delta time. And so with Delta, we saw it drop into the 70% range, and then for Omicron, we saw it drop even lower, to the 50% range. And so I think what we’re seeing here is that the bivalent vaccine really brings you back to that sort of effectiveness that we would have seen immediately after past boosters, which is great. That’s where we want it to get,” said Dr. Ruth Link-Gelles, an epidemiologist at the US Centers for Disease Control and Prevention.

“This protection is not 100%, but it is something,” Link-Gelles said. “Especially going into the holidays where you’re likely to be traveling, spending time with elderly relatives, with vulnerable people. I think having some protection from infection and therefore some protection from infecting your loved one is better than having no protection at all.”

Link-Gelles says it also means that people should continue to adopt a layered approach to protection, utilizing rapid tests, good-quality masks and ventilation as a comprehensive approach, rather than relying on vaccines alone.

“This should be sort of one of the things in your toolbox for protecting yourself and your family,” she said. “Personally, we’re my family is all vaccinated up to date, but I think if we go to the airport tomorrow, we’ll be wearing our N95 [masks] because we’re seeing elderly relatives this weekend. And while we of course trust the vaccines, and I’m not super worried about a mild infection in myself or my healthy husband, we certainly would not want to infect his grandmother.”

Link-Gelles added that she expects that vaccine protection against severe outcomes from Covid-19, like hospitalization and death, will be higher, but that data isn’t in yet.

The study, which was led by CDC scientists, relied on health records from more than 360,000 tests given at nearly 10,000 retail pharmacies between Sept. 14 and Nov. 11, a period when the BA.4 and BA.5 subvariants were causing most Covid-19 infections in the US. The study included people ages 18 and up who had Covid-19 symptoms and were not immunocompromised.

The study looked at how effective the boosters were in two ways: Researchers calculated a value called absolute vaccine effectiveness, which compared the odds of symptomatic infection in people who received bivalent boosters with those who reported being unvaccinated. They also calculated relative vaccine effectiveness, which looked at the odds of symptomatic infection in people who received updated bivalent boosters compared with those who had two, three or four doses of the original single-strain vaccine.

Compared with people who were unvaccinated, adults 18 to 49 who had gotten bivalent boosters were 43% less likely to get sick with a Covid-19 infection. Older adults, who tend to have weaker immune function, got less protection. Those ages 50 to 64 were 28% less likely, and those ages 65 and up were 22% less likely to get sick with Covid-19 than the unvaccinated group.

The relative vaccine effectiveness showed the added protection people might expect on top of whatever protection they had left after previous vaccine doses. If a person was two to three months past their last vaccine dose, the bivalent boosters added an average of 30% protection for those who were ages 18 to 49, 31% more protection if they were 50 to 64, and 28% more protection if they were 65 or older. At 3 months after their last booster, people ages 50 and older still had about 20% protection from Covid-19 illness, CDC data show. So overall, the updated boosters got them to around 50% effectiveness against symptomatic infection.

If a person was more than eight months away from their last vaccine dose, they got more protection from the boosters. But Link-Gelles said that by eight months, there was little protection left from previous shots against Omicron and its variants, meaning the vaccine effectiveness for this group was probably close to their overall protection against infection.

Those ages 18 to 49 who were eight months or more past their last dose of a vaccine had 56% added protection against a Covid-19 infection with symptoms; adults 50 to 64 had 48% added protection, and adults over 65 had 43% added protection, on top of whatever was left from previous vaccinations.

John Moore, an immunologist and microbiologist at Weill Cornell Medicine, said it boils down to the fact that that boosters will probably cut your risk of getting sick by about 50%, and that protection probably won’t last.

“Having a booster will give you some additional protection against infection for a short term, which is always what we see with a booster, but it won’t last long. It’ll decline, and it will decline more as the more resistant variants spread,” said Moore, who was not involved in the new research.

The immunity landscape in the United States is more complex than ever. According to CDC data, roughly two-thirds of Americans have completed at least their primary series of Covid-19 vaccines. And data from blood tests shows that almost all Americans have some immunity against the virus, thanks to infection, vaccination or both.

A new preprint study from researchers at Harvard and Yale estimates that 94% of Americans have been infected with the virus that causes Covid-19 at least once, and 97% have been infected or vaccinated, increasing protection against a new Omicron infection from an estimated 22% in December 2021 to 63% by November 10, 2022. Population protection against severe disease rose from an estimated 61% in December 2021 to around 89%, on average, this November.

All of this means the US is in a better spot, defensively at least, than it ever has been against the virus – which is not to say that the country couldn’t see another Covid-19 wave, especially if a new variant emerges that is very different from what we’ve seen, if immunity continues to wane or if behavior shifts dramatically.



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