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Tag: pharmaceuticals and prescription drugs

  • Indian maker of cough syrup linked to Uzbekistan deaths halts production | CNN Business

    Indian maker of cough syrup linked to Uzbekistan deaths halts production | CNN Business

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    New Delhi
    CNN
     — 

    The Indian maker of a cough syrup linked to at least 18 deaths in Uzbekistan has halted production after an investigation by drug regulators, India’s health minister said Friday.

    Uzbekistan’s health ministry said the cough syrup, Doc-1, manufactured by the Indian pharmaceutical company Marion Biotech, had contained ethylene glycol, a toxic solution.

    The Uzbek ministry said seven employees have been dismissed due to negligence and that all relevant documents have been given to law enforcement for an investigation. The ministry also said the cough syrup was incorrectly used by parents.

    On Friday, Indian heath minister Mansukh Mandaviya tweeted that all Marion Boitech’s manufacturing activities at their headquarters in the northern state of Uttar Pradesh had been stopped as of Thursday evening “while further investigation is ongoing,” following an inspection by India’s drug regulatory agency.

    Marion Biotech could not be immediately reached for comment.

    Hasan Harris, Marion Biotech’s legal head, told Indian news agency ANI: “We await the reports, the factory was inspected. We’ve halted production of all medicines.” As of Friday, the company’s website was not operational.

    In a statement Tuesday, Uzbekistan said the Doc-1 Max syrup was incorrectly used by parents as an anti-cold remedy on their own or on the recommendation of pharmacy sellers and this resulted in respiratory distress in children who consumed the medication.

    The Uzbek health ministry said in its statement that the deceased children had taken 2.5-5ml of the drug at home for 2-7 days, which exceeds the standard dose of the drug for children, prior to being admitted to the hospital. All children had been given the drug without a doctor’s prescription, the ministry added.

    It remains unclear how many of the children consumed the cough syrup tainted with ethylene glycol, or had been given more than the standard dosage, or both.

    The ministry said it had withdrawn all tablets and syrups of the drug from pharmacies across the country and said that 7 responsible employees have been dismissed from their positions “due to negligent and careless attitude to their duties.” It also said disciplinary measures are being applied against a number of specialists, but it did not specify who or what those measures would be.

    Ethylene glycol is commonly found in anti-freeze used in motor vehicles. If ingested, it can damage the brain, lungs, liver and kidneys, and can lead to death.

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  • Justice Department sues pharmaceutical company for allegedly failing to report suspicious opioid sales | CNN Politics

    Justice Department sues pharmaceutical company for allegedly failing to report suspicious opioid sales | CNN Politics

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    Washington
    CNN
     — 

    The Justice Department on Thursday alleged that the AmerisourceBergen Corporation, one of the country’s largest pharmaceutical distributors, and two of its subsidiaries failed to report hundreds of thousands of suspicious prescription opioid orders to pharmacies across the country.

    The lawsuit, which spans several states, alleges that AmerisourceBergen disregarded its legal obligation to report orders of controlled substances to the Drug Enforcement Agency for nearly a decade. The company ignored “red flags” that pharmacies in West Virginia, New Jersey, Colorado and Florida were diverting opioids into illegal drug markets, the suit says.

    “The Department of Justice is committed to holding accountable those who fueled the opioid crisis by flouting the law,” Associate Attorney General Vanita Gupta said in a statement Thursday.

    “Companies distributing opioids are required to report suspicious orders to federal law enforcement. Our complaint alleges that AmerisourceBergen – which sold billions of units of prescription opioids over the past decade – repeatedly failed to comply with that requirement,” she added.

    If AmerisourceBergen is found liable at trial, the company faces billions of dollars in financial penalties, the Justice Department said.

    Lauren Esposito, a spokesperson for AmerisourceBergen, countered on Thursday in a statement that said the Justice Department’s complaint rested on “five pharmacies that were cherry picked out of the tens of thousands of pharmacies that use AmerisourceBergen as their wholesale distributor, while ignoring the absence of action from former administrators at the Drug Enforcement Administration – the DOJ’s own agency.”

    She added: “With the vast quantity of information that AmerisourceBergen shared directly with the DEA with regards to these five pharmacies, the DEA still did not feel the need to take swift action itself – in fact, AmerisourceBergen terminated relationships with four of them before DEA ever took any enforcement action while two of the five pharmacies maintain their DEA controlled substance registration to this day.”

    Yet AmerisourceBergen was allegedly aware that in two of the pharmacies, drugs it distributed were likely being sold in parking lots for cash, the Justice Department said. In another pharmacy, the company was allegedly warned that patients likely suffering from addiction were receiving opioids, including some people who later died of a drug overdose.

    The Justice Department also noted in its lawsuit that AmerisourceBergen’s reporting systems for suspicious opioid orders were deeply inadequate, and that the company intentionally changed its reporting systems to reduce the number of orders flagged as suspicious amid the opioid epidemic.

    Even when orders were flagged as suspicious, AmerisourceBergen often didn’t report those orders to the DEA, according to the complaint.

    Opioids are involved in the vast majority of drug overdose deaths, though synthetic opioids – particularly fentanyl – have played an outsized role. Synthetic opioids – excluding methadone – were involved in more than 72,000 overdose deaths in 2021, about two-thirds of all overdose deaths that year and more than triple the number from five years earlier.

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  • House investigation says FDA approval process of Alzheimer’s drug was ‘rife with irregularities’ | CNN

    House investigation says FDA approval process of Alzheimer’s drug was ‘rife with irregularities’ | CNN

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    CNN
     — 

    A congressional investigation found that the US Food and Drug Administration’s “atypical collaboration” to approve a high-priced Alzheimer’s drug was “rife with irregularities.”

    The report, released Thursday, was the result of an 18-month investigation by two House committees. It is sharply critical of Biogen, maker of the medication Aduhelm.

    The report says Biogen set an “unjustifiably high price” for Aduhelm to “make history” for the company, and thought of the drug as an “unprecedented financial opportunity.” Biogen priced Aduhelm at $56,000 per year, even though its actual effects on a broad patient population were unknown.

    More than 6.5 million people in the US live with Alzheimer’s, and that number is expected to grow to 13.8 million by 2060, according to the Alzheimer’s Association. The disease is the sixth leading cause of death in the United States. There is no cure, and effective treatments are extremely limited. Before Aduhelm’s approval in June 2021, the FDA had not approved a novel therapy for the condition since 2003.

    The investigation found that Biogen planned an aggressive marketing campaign to launch the drug, intending to spend more than $3.3 billion on sales and marketing between 2020 and 2024 – more than 2½ times what it spent to develop Aduhelm.

    Dementia, including Alzheimer’s, is one of the “costliest conditions to society,” according to the Alzheimer’s Association. In 2022 alone, Alzheimer’s and other dementias cost the US $321 billion, including $206 billion in Medicaid and Medicare payments, the association says.

    Aduhelm’s cost to patients and to Medicare would be significant, the new report says. It was one of the key factors behind a big increase in Medicare premiums in 2022, according to the Centers for Medicare and Medicaid Services.

    In anticipation of “pushback” from providers and payers, the report says, Biogen also prepared a narrative to sell the value of the drug.

    The Committee on Oversight and Reform and the Committee on Energy and Commerce found that the collaboration between the FDA and Biogen in the approval process of the drug “exceeded the norm in some respects.”

    Biogen had initially discontinued Aduhelm’s clinical trials in March 2019 after an independent committee found that it probably would not slow the cognitive and functional impairment – the decline in memory, language and judgment – that comes with Alzheimer’s. But in June 2019, the FDA and Biogen started a “working group” to see whether the effort could be saved.

    The investigation found that the FDA and Biogen engaged in at least 115 meetings, calls and substantive email discussions from July 2019 to July 2020, including 40 meetings to guide Aduhelm’s potential approval. There may have been even more meetings, but the committees say the FDA failed to follow its own documentation protocol.

    The agency then collaborated with Biogen to draft a document used to brief an independent advisory committee that met in November 2020. The trial results were mixed, with only one showing a small benefit to patients.

    At that meeting, none of the committee’s members voted to say that the studies presented strong evidence that the drug was effective at treating Alzheimer’s.

    The meeting was unusual, according to one former FDA adviser who had sat on the committee for several years. Dr. Aaron Kesselheim told CNN in 2021 that the relationship between the FDA and the company was out of the ordinary.

    “There was a strange dynamic compared to the other advisory committee meetings I’ve attended,” the professor at Harvard Medical School said. “Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug.”

    When the FDA approved the drug, Kesselheim and two other members of the advisory committee resigned in protest. He later labeled it “probably the worst drug approval decision in recent US history.”

    The FDA often follows the independent committee’s recommendations, but in this case, it changed course and used its accelerated approval pathway, which sets a different standard of proof that a treatment could work.

    The committee members said senior FDA leadership told them that the shift in how the drug would be approved came after an FDA expert council meeting in April 2021 provided “unfavorable feedback” for the traditional approval process, according to the new report.

    The FDA also approved the drug for “people with Alzheimer’s disease,” a far broader population than was studied in Biogen’s clinical trials.

    Internal documents from the company said that Biogen accepted this broader indication “despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,” the report says. Leaders expressed concern that the company could lose credibility, and it developed a communications strategy to deal with the “anticipated fallout,” the report says.

    The committees recommended that the FDA document all of its meetings with drug sponsors, establish a protocol for briefing documents and advisory committees, and update its guidance for how Alzheimer’s drugs are developed and reviewed.

    The committees also recommended that companies clearly communicate safety and efficacy concerns to the FDA and consider the value assessments made by outside experts when setting drug prices.

    “The American people rely on FDA for assurance on the safety and efficacy of the medications they take. The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” the report says.

    The FDA said in a statement that its “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”

    The agency says it is reviewing the committees’ findings and recommendations and says its own review found that the interactions with Biogen were appropriate.

    “It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients. That said, the agency has already started implementing changes consistent with the Committee’s recommendations.”

    Biogen said in a statement Thursday that it has been working “cooperatively” with the investigation.

    “Biogen has been committed to researching and developing treatments for Alzheimer’s disease for more than a decade. We have been focused relentlessly on innovation to address this global health challenge, and have adapted to both successes and setbacks,” it said. “Biogen stands by the integrity of the actions we have taken.”

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  • Beijing to distribute Pfizer antiviral drug as Covid wave strains health system | CNN

    Beijing to distribute Pfizer antiviral drug as Covid wave strains health system | CNN

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    Beijing
    CNN
     — 

    Beijing will begin distributing Pfizer’s Covid-19 drug Paxlovid to the city’s community health centers in the coming days, state media reported Monday.

    The report comes as the city grapples with an unprecedented wave of infections that has severely strained its hospitals and emptied pharmacy shelves.

    The state-run China News Service reported Monday that after receiving training, community doctors will administer the medicine to Covid-19 patients and give instructions on how to use them.

    “We have received the notice from officials, but it is not clear when the drugs will arrive,” it cited a worker at a local community health center in Beijing’s Xicheng district as saying.

    Paxlovid remains the only foreign medicine to treat Covid that has been approved by China’s regulator for nationwide use, but access is extremely difficult to come by. When a Chinese healthcare platform offered the antiviral drug earlier this month, it sold out within hours.

    Azvudine, an oral medicine developed by China’s Genuine Biotech, has also been approved.

    After nearly three years of lockdowns, quarantines and mass testing, China abruptly abandoned its zero-Covid policy this month following nationwide protests over its heavy economic and social toll.

    The sudden lifting of restrictions sparked panic buying of fever and cold medicines, leading to widespread shortages, both at pharmacies and on online shopping platforms. Long lines have become routine outside fever clinics and hospital wards overflowing with patients in the capital Beijing and elsewhere in the country.

    An emergency room doctor in Beijing told the state-run People’s Daily on Thursday that four doctors on his shift did not have time to eat or drink. “We have been seeing patients nonstop,” he said.

    Another emergency room doctor told the newspaper he had been working despite having developed fever symptoms. “The number of patients is high, and with fewer medical staff, the pressure is multiplied,” said the doctor.

    In a sign of the strain on Beijing’s medical system, hundreds of health professionals from across China have traveled to the city to assist medical centers.

    As the capital, Beijing has some of the best medical resources in the country. However, the abrupt zero-Covid u-turn has left people and health facilities ill-prepared to deal with a surge in infections.

    China’s official Covid case count has become meaningless after it rolled back mass testing and allowed residents to use antigen tests and isolate at home. It has stopped reporting asymptomatic cases, conceding it was no longer possible to track the actual number of infections.

    According to an internal estimate from the National Health Commission, almost 250 million people in China have caught Covid in the first 20 days of December – accounting for roughly 18% of the country’s population.

    Experts have warned that as people in big cities return to their hometowns for the Lunar New Year next month, the virus could sweep through China’s vast rural areas, where vaccination rates are lower and medical resources are severely lacking.

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  • Why people in China are panic buying canned yellow peaches as Covid surges | CNN Business

    Why people in China are panic buying canned yellow peaches as Covid surges | CNN Business

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    Hong Kong
    CNN
     — 

    An unprecedented wave of Covid cases in China has sparked panic buying of fever medicines, pain killers, and even home remedies such as canned peaches, leading to shortages online and in stores.

    Authorities said Wednesday they had detected 2,249 symptomatic Covid-19 cases nationally through nucleic acid testing, 20% of which were detected in the capital Beijing. CNN reporting from the city indicates the case count in the Chinese capital could be much higher than recorded.

    Demand for fever and cold medicines, such as Tylenol and Advil, is surging nationally as people rush to stockpile drugs amid fears they may contract the virus.

    Canned yellow peaches, considered a particularly nutritious delicacy in many parts of China, have been snapped up by people looking for ways to fight Covid. The product is currently sold out on many online shops.

    Its sudden surge in popularity prompted Dalian Leasun Food, one of the country’s largest canned food manufacturers, to clarify in a Weibo post that canned yellow peaches don’t have any medicinal effect.

    “Canned yellow peaches ≠ medicines!” the company said in the post published Friday. “There is enough supply, so there is no need to panic. There is no rush to buy.”

    The People’s Daily, the mouthpiece of the Communist Party, also tried to set the record straight. It published a long Weibo post on Sunday urging the public not to stockpile the peaches, calling them “useless in alleviating symptoms of illness.”

    Authorities also pleaded with the public not to stockpile medical supplies. On Monday, the Beijing city government warned residents that it was facing “great pressure” to meet demand for drug and medical services because of panic buying and an influx of patients at clinics.

    It urged the public not to hoard drugs or call emergency services if they have no symptoms.

    The rising demand and shortage of supply of Covid remedies have fueled bets on drugmakers.

    Shares of Hong Kong-listed Xinhua Pharmaceutical, China’s largest manufacturer of ibuprofen, have gained 60% in the past five days. The stock has so far jumped by 147% in the first two weeks of this month.

    “Our company’s production lines are operating at full capacity, and we are working overtime to produce urgently needed medicines, such as ibuprofen tablets,” Xinhua Pharmaceutical said Monday.

    Ibuprofen is an anti-inflammatory drug used to treat pain and fever. It is also known as Advil, Brufen, or Fenbid.

    The drug shortage has spread from mainland China to Hong Kong, a special administrative region which has a separate system of local government. On Sunday, the city’s health chief urged the public to refrain from panic buying cold medicines they do not need and urged residents “not to overact.”

    In some Hong Kong drugstores, fever drugs such as Panadol, the local brand name for Tylenol, have sold out. Most of the buyers were sending the medicines to their families and friends in the mainland, sales representatives told CNN.

    Shares of Shenzhen-listed Guizhou Bailing Group Pharmaceuticals, known for making cough syrup, have gained 21% this week and risen 51% so far this month. Yiling Pharmaceutical, the sole producer of Lianhua Qingwen, a traditional Chinese medicine recommended by the government for treating Covid, has also jumped more than 30% in the past month.

    Even providers of funeral services and burial plots have gotten a huge boost. Shares in Hong Kong-traded Fu Shou Yuan International, China’s largest burial service company, have soared more than 50% since last month.

    There is “strong pent-up demand for burial plots” in 2023, analysts from Citi Group said in a recent research report, adding that they’ve noticed increasing investor interest in the sector.

    They cited the existence of hundreds of thousands of cremated remains, which are being temporarily stored in government facilities awaiting burial. Lockdowns across much of the country have halted funeral services, they said.

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  • As China moves away from zero-Covid, health experts warn of dark days ahead | CNN

    As China moves away from zero-Covid, health experts warn of dark days ahead | CNN

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    Editor’s Note: Editor’s Note: A version of this story appeared in CNN’s Meanwhile in China newsletter, a three-times-a-week update exploring what you need to know about the country’s rise and how it impacts the world. Sign up here.


    Hong Kong
    CNN
     — 

    China’s zero-Covid policy, which stalled the world’s second-largest economy and sparked a wave of unprecedented protests, is now being dismantled as Beijing on Wednesday released sweeping revisions to its draconian measures that ultimately failed to bring the virus to heel.

    The new guidelines keep some restrictions in place but largely scrap the health code system that required people to show negative Covid-19 tests for daily activities and roll back mass testing. They also allow some Covid-19 cases and close contacts to skip centralized quarantine.

    They come after a number of cities in recent days started to lift some of the harsh controls that dictated – and heavily restricted – daily life for nearly three years in China.

    But while the changes mark a significant shift – and bring relief for many in the public who’ve grown increasingly frustrated with the high costs and demands of zero-Covid – another reality is also clear: China is underprepared for the surge in cases it could now see.

    Experts say though much is still unknown about how the next weeks and months will progress, China has fallen short on preparations like bolstering the elderly vaccination rate, upping surge and intensive care capacity in hospitals, and stockpiling antiviral medications.

    While the Omicron variant is milder than previous strains and China’s overall vaccination rate is high, even a small number of severe cases among vulnerable and under-vaccinated groups like the elderly could overwhelm hospitals if infections spike across the country of 1.4 billion, experts say.

    “This is a looming crisis – the timing is really bad … China now has to relax much of its measures during the winter (overlapping with flu season), so that was not as planned,” said Xi Chen, an associate professor at the Yale School of Public Health in the United States, pointing to what was likely an acceleration in China’s transition, triggered by public discontent.

    The guidelines released Wednesday open up a new chapter in the country’s epidemic control, three years after the first cases of Covid-19 were detected in central China’s Wuhan and following protests against the zero-Covid policy across the country starting late last month.

    Where China once controlled cases by requiring testing and clear health codes for entry into a number of public places and for domestic travel, those codes will no longer be checked except for in a handful of locations like medical institutions and schools. Mass testing will now be rolled back for everyone except for those in high-risk areas and high-risk positions. People who test positive for Covid-19 but have mild or asymptomatic cases and meet certain conditions can quarantine at home, instead of being forced to go to centralized quarantine centers, as can close contacts.

    Locations classified by authorities as “high risk” can still be locked down, but these lockdowns must now be more limited and precise, according to the new guidelines, which were circulated by China’s state media.

    The changes mark a swift about-face, following mounting public discontent, economic costs and record case numbers in recent weeks. They come after a top official last week first signaled the country could move away from the zero-Covid policy it had long poured significant resources into – though another official on Wednesday said the measures were a “proactive optimization,” not “reactive” when asked in a press briefing.

    “China has pursued this policy for so long, they’re now between a rock and a hard place,” said William Schaffner, a professor of infectious diseases at the Vanderbilt University Medical Center in the US. “They don’t have good options in either direction anymore. They had really hoped that this epidemic globally would run its course, and they could survive without impact. And that hasn’t happened.”

    As restrictions are relaxed, and the virus spreads across the country, China is “going to have to go through a period of pain in terms of illness, serious illness, deaths and stress on the health care system” as was seen elsewhere in the world earlier in the pandemic, he added.

    Since the global vaccination campaign and the emergence of the Omicron variant, health experts have questioned China’s adherence to zero-Covid and pointed out the unsustainability of the strategy, which tried to use mass testing and surveillance, lockdowns and quarantines to stop a highly contagious virus.

    But as some restrictions are lifted, in what appears to be a haphazard transition following years of focus on meticulously controlling the virus, experts say change may be coming before China has made the preparations its health officials have admitted are needed.

    “An uncontrolled epidemic (one which only peaks when the virus starts running out of people to infect) … will pose serious challenges to the health care system, not only in terms of managing the small fraction of Covid cases that are severe, but also in the ‘collateral damage’ to people with other health conditions who have delayed care as a consequence,” said Ben Cowling, a professor of epidemiology at the University of Hong Kong.

    But even with easing restrictions, Cowling said, it was “difficult to predict” how quickly infections will spread though China, because there are still some measures in place and some people will change their behavior – such as staying at home more often.

    “And I wouldn’t rule out the possibility that stricter measures are reintroduced to combat rising cases,” he said.

    Experts agree that allowing the virus to spread nationally would be a significant shift for a country that up until this point has officially reported 5,235 Covid-19 deaths since early 2020 – a comparatively low figure globally that has been a point of pride in China, where state media until recently trumpeted the dangers of the virus to the public.

    Modeling from researchers at Shanghai’s Fudan University published in the journal Nature Medicine in May projected that more than 1.5 million Chinese could die within six months if Covid-19 restrictions were lifted and there was no access to antiviral drugs, which have been approved in China.

    However, death rates could fall to around the levels of seasonal flu, if almost all elderly people were vaccinated and antiviral medications were broadly used, the authors said.

    Last month, China released a list of measures to bolster health systems against Covid-19, which included directives to increase vaccination in the elderly, stockpile antiviral treatments and medical equipment, and expand critical care capacity – efforts that experts say take time and are best accomplished prior to an outbreak.

    “(Is China prepared?) If you look at surge capacity three years on and the stockpiling of effective antivirals – no. If you talk about the triage procedures – they are not strictly enforced – and if you talk about the vaccination rate for the elderly, especially those aged 80 and older, it is also overall no,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations in New York.

    Chinese authorities, he added, would likely be closely assessing outcomes like the death rate to decide policy steps going forward.

    Citizens wearing masks board a subway train on Monday in Henan province's Zhengzhou, where negative Covid-19 test results are no longer required for riding public transport.

    The US has at least 25 critical care beds per 100,000 people, according to the Organization for Economic Co-operation and Development – by contrast, China has fewer than four for the same number, health authorities there said last month.

    The system also provides limited primary care, which could drive even moderately sick people to hospitals as opposed to calling a family doctor – putting more strain on hospitals, according to Yale’s Chen.

    Meanwhile, weak medical infrastructure in rural areas could foster crises there, especially as testing is reduced and younger people living in cities return to rural hometowns to visit elderly family members over the Lunar New Year next month, he said.

    While China’s overall vaccination rate is high, its elderly are also less protected than in some other parts of the world, where the oldest and most vulnerable to dying from Covid-19 were prioritized for vaccination. Some countries have already rolled out fourth or fifth doses for at-risk groups.

    By China’s accounting, more than 86% of China’s population over 60 are fully vaccinated, according to China’s National Health Commission, and booster rates are lower, with more than 45 million of the fully vaccinated elderly yet to receive an additional shot. Around 25 million elderly who have not received any shot, according to a comparison of official population figures and November 28 vaccination data.

    For the most at-risk over 80 age group, around two-thirds were fully vaccinated by China’s standards, but only 40% had received booster shots as of November 11, according to state media.

    But while China refers to third doses for its widely used inactivated vaccines as booster shots, a World Health Organization vaccine advisory group last year recommended that elderly people taking those vaccines receive three doses in their initial course to ensure sufficient protection.

    The inactivated vaccines used in China have been found to elicit lower levels of antibody response as compared to others used overseas, and many countries using the doses have paired them with more protective mRNA vaccines, which China has not approved for use.

    Cowling said evidence from Hong Kong’s outbreak, however, showed China’s inactivated vaccines worked well to prevent severe disease, but it was critical that the elderly receive three doses in the initial course, as recommended by the World Health Organization. They should then use a fourth dose on top of that to keep immunity high, he added.

    Top health officials on November 28 announced a new plan to bolster elderly vaccination rates, but such measures will take time, as will other preparations for a surge.

    Minimizing the worst outcomes in a transition out of zero-Covid depends on that preparation, according to Cowling. From that perspective, he said, “it doesn’t look like it would be a good time to relax the policies.”

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  • Early research suggests promising use of AI to predict risk of heart attack or stroke using a single chest X-ray | CNN

    Early research suggests promising use of AI to predict risk of heart attack or stroke using a single chest X-ray | CNN

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    CNN
     — 

    Early research suggests a promising use of artificial intelligence to predict the 10-year risk of death from a heart attack or stroke from a single chest X-ray.

    The preliminary findings were presented Tuesday at the annual meeting of the Radiological Society of North America. The research is in the final draft stages and has not been submitted for publication in a medical journal.

    Researchers used nearly 150,000 chest X-rays to train an artificial intelligence program to identify patterns in the images associated with risk from major cardiovascular disease events. They tested the program on a separate group of about 11,000 people and found “significant association” between the risk level predicted by the AI and the actual occurrence of a major cardiovascular disease event.

    The clinical standard for analyzing risk from cardiovascular disease is the atherosclerotic cardiovascular disease (ASCVD) risk score, a calculator that weights various patient data points that have been found to have a high association with adverse cardiovascular events, including age, blood pressure and history of smoking.

    Statin medication is recommended for people with a 10-year risk of 7.5% or higher. The AI model uses the same risk thresholds as the established risk calculator, and early findings suggest that it works just as well.

    “We’ve long recognized that X-rays capture information beyond traditional diagnostic findings, but we haven’t used this data because we haven’t had robust, reliable methods,” said Dr. Jakob Weiss, the lead researcher and a radiologist affiliated with Massachusetts General Hospital and the AI in Medicine program at Harvard Medical School’s Brigham and Women’s Hospital.

    Sometimes, the AI findings align with a traditional radiology reading, but other times, it picks up on things that may have been missed, he said.

    “Part of it is anatomical alterations that we would also pick up with our naked eye and that make physiological sense. Let’s say there’s increased blood pressure or cardiac failure – these are findings that we can pick up in a normal chest radiograph as well. But I think a lot of the information captured or extracted is somewhere embedded in the scan, but we can’t make sense of it as traditionally trained radiologists as of now,” Weiss said.

    “It has this black box character to it,” he said, which can sometimes make it hard to communicate risk to patients without an explanation to pinpoint.

    Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University’s Feinberg School of Medicine and former president of the American Heart Association, was co-chair of the risk assessment panel when the ASCVD risk calculator was created in 2013 and a key player in 2018 when the guidelines were updated to emphasize the relationship between the risk score and personal medical history.

    He was not involved in the new AI research but says it’s important to keep the field moving forward.

    “This is exactly the kind of application that artificial intelligence is best for,” he said. “So we need to continue to do things like this to really understand if we can find, particularly, patients who would otherwise slip through the cracks. I think that’s where it may be most useful.”

    But collecting all of the patient data points that go into the established risk calculator is still critical – because they’re actionable. And whether risk is calculated using a statistical formula or an AI model, the most successful outcomes will still require personalized patient assessments.

    “We don’t cure smoking by a chest X-ray. We actually need to work with the patient to find ways to get them to stop smoking,” Lloyd-Jones said. “The risk calculator is one part of risk assessment, but it’s not the only part. It’s a process that involves both the patient and the doctor in a discussion about what is the patient’s risk and how much we think a statin would help them.”

    For their research, Weiss and co-authors trained the AI using chest X-rays from participants in the National Cancer Institute’s Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. It was tested on people who had a routine outpatient chest X-ray at Mass General Brigham and were potentially eligible for statin therapy, with an average age of 60.

    Additional research, including a controlled randomized trial, is necessary to validate the deep learning model.

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  • Don’t bother with dietary supplements for heart health, study says | CNN

    Don’t bother with dietary supplements for heart health, study says | CNN

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    CNN
     — 

    Six supplements that people commonly take for heart health don’t help lower “bad” cholesterol or improve cardiovascular health, according to a study published Sunday, but statins did.

    Some people believe that common dietary supplements – fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice – will lower their “bad” cholesterol. “Bad” cholesterol, known in the medical community as low-density lipoproteins or LDL, can cause the buildup of fatty deposits in the arteries. The fatty deposits can block the flow of oxygen and blood that the heart needs to work and the blockage can lead to a heart attack or stroke.

    For this study, which was presented at the American Heart Association’s Scientific Sessions 2022 and simultaneously published in the Journal of the American College of Cardiology, researchers compared the impact of these particular supplements to the impact of a low dose of a statin – a cholesterol-lowering medication – or a placebo, which does nothing.

    Researchers made this comparison in a randomized, single-blind clinical trial that involved 190 adults with no prior history of cardiovascular disease. Study participants were ages 40 to 75, and different groups got a low-dose statin called rosuvastatin, a placebo, fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for 28 days.

    The statin had the greatest impact and significantly lowered LDL compared with the supplements and placebo.

    The average LDL reduction after 28 days on a statin was nearly 40%. The statin also had the added benefit on total cholesterol, which dropped on average by 24%, and on blood triglycerides, which dropped 19%.

    None of the people who took the supplements saw any significant decrease in LDL cholesterol, total cholesterol or blood triglycerides, and their results were similar to those of people who took a placebo. While there were similar adverse events in all the groups, there were a numerically higher number of problems among those who took the plant sterols or red yeast rice.

    “We designed this study because many of us have had the same experience of trying to recommend evidence-based therapies that reduce cardiovascular risks to patients and then having them say ‘no thanks, I’ll just try this supplement,’ ” said study co-author Dr. Karol Watson, professor of medicine/cardiology and co-director, UCLA Program in Preventive Cardiology. “We wanted to design a very rigid, randomized, controlled trial study to prove what we already knew and show it in a rigorous way.”

    Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and a co-author on the study, said that patients often don’t know that dietary supplements aren’t tested in clinical trials. He calls these supplements “21st century snake oil.”

    In the United States, the Dietary Supplement and Health Education Act of 1994 sharply limited the US Food and Drug Administration’s ability to regulate supplements. Unlike pharmaceutical products that have to be proven safe and effective for their intended use before a company can market them, the FDA doesn’t have to approve dietary supplements before they can be sold. It is only after they are on the market and are proven to be unsafe that the FDA can step in to regulate them.

    “Patients believe studies have been done and that they are as effective as statins and can save them because they’re natural, but natural doesn’t mean safe and it doesn’t mean they’re effective,” Nissen said.

    The study was funded via an unrestricted grant from AstraZeneca, which makes rosuvastatin. The company did not have any input on the methodology, data analysis and discussion of the clinical implications, according to the study.

    The researchers acknowledged some limitations, including the study’s small sample size, and that its 28-study period might not capture the effect of supplements when used for a longer duration.

    In a statement on Sunday, the Council for Responsible Nutrition, a trade association for the dietary supplement industry, said “supplements are not intended to replace medications or other medical treatments.”

    “Dietary supplements are not intended to be quick fixes and their effects may not be revealed during the course of a study that only spans four weeks,” Andrea Wong, the group’s senior vice president for scientific and regulatory affairs, said in a statement.

    Dr. James Cireddu, an invasive cardiologist and medical director of University Hospitals Harrington Heart & Vascular Institute at University Hospitals Bedford Medical Center, said the work is going to be helpful.

    “They did a nice job collecting data and looking at the outcomes,” said Cireddu, who did not work on the study. “It will probably resonate with patients. I get asked about supplements all the time. I think this does a nice job of providing evidence.”

    Dr. Amit Khera, chair of the AHA Scientific Sessions programming committee, did not work on the research, but said he thought this was an important study to include in the presentations this year.

    “I take care of patients every day with these exact questions. Patients always ask about the supplements in lieu of or in addition to statins,” said Khera, who is a professor and director of preventive cardiology at UT Southwestern Medical Center. “I think if you have high quality evidence and a well done study it is really critical to help inform patients about the value, or in this case the lack of value, for some of these supplements for cholesterol lowering.”

    Statins have been around for more than 30 years and they’ve been studied in over 170,000 people, he said. Consistently, studies show that statins lower risk.

    “The good news, we know statins work,” Khera said. “That does not mean they’re perfect. That doesn’t mean everyone needs one, but for those at higher risk, we know they work and that’s well proven. If you’re going to do something different you have to make sure it works.”

    With supplements, he said he often sees misinformation online.

    “I think that people are always looking for something ‘natural’ but you know there’s a lot of issues with that terminology and most important we should ask do they work? That’s what this study does,” Khera adds. “It’s important to ask, are you taking something that is proven, and if you’re doing that and it’s not, is that in lieu of proven treatment. It’s a real concern.”

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  • Surveillance plane helping take fentanyl pills off the streets faces extinction | CNN Politics

    Surveillance plane helping take fentanyl pills off the streets faces extinction | CNN Politics

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    Washington
    CNN
     — 

    GOP Rep. Adam Kinzinger, who also serves as a pilot in the Air National Guard, is sounding the alarm about plans to cut funding for a little-known military surveillance aircraft that law enforcement officials tell CNN is an essential tool for dismantling drug trafficking organizations and has helped them take tens of thousands of illegal fentanyl pills off the streets last month alone.

    Kinzinger is among a small group of Air National Guard pilots who operate the twin-engine RC-26 aircraft and have helped law enforcement agencies target large shipments of fentanyl that are flowing into the US from across the border.

    But despite being described as an essential asset for law enforcement officials on the ground as they carry out raids and serve search warrants, the aircraft currently finds itself on the chopping block as Air Force leaders are planning to scrap the program, he told CNN.

    “Law enforcement lives have been saved by having this asset available,” according to Kinzinger. “We can see anything weird that’s going to happen,” he said, adding that pilots can also follow suspects with their aerial camera without them knowing, allowing agents to maintain the element of surprise.

    “We’ve been saving it every year piecemeal,” he said. “The guard has made it very clear. It’s gone in April.”

    Law enforcement officials from around the country and National Guard pilots who fly the RC-26 have appealed directly to Air Force leaders in Washington to keep the plane or provide a capable replacement, according to multiple sources familiar with those discussions.

    But despite self-imposed limits to the types of operations that can be flown by RC-26 National Guard pilots, Air Force leaders have now decided they no longer want to fund piloted reconnaissance assets for border and counter-drug missions, claiming unmanned drones can be offered up to fill that need, Kinzinger said.

    Supporters of the aircraft like Kinzinger say, in reality, the Air Force does not currently have a plan to replace the capabilities provided by the RC-26 if the program is shuttered.

    The Air Force has determined that divestment of the RC-26 “leaves no capability gap” and the service possesses sufficient “Intelligence, Surveillance and Reconnaissance assets” to support the needs of law enforcement authorities, Air Force spokesperson Ann Stefanek told CNN in response to questions about the future of the aircraft.

    A law enforcement official who spoke to CNN under the condition of anonymity to speak frankly about his opposition to the Air Force’s plans to get rid of the aircraft, said doing so would take away the biggest advantage officers have over drug trafficking organizations that are currently “flooding the market” with large quantities of fentanyl and killing swaths of Americans in the process.

    “I know the Air Force is trying to say there are other options … but they don’t have the same capabilities,” the law enforcement official, who has routinely requested assistance from Air National Guard pilots operating the RC-26, said.

    “It would be a great loss for us in law enforcement,” he added, noting it allows police departments to work more cases and spend less money on things like overtime for officers.

    While the RC-26 is used for a variety of missions, it has proven to be very effective in helping law enforcement agencies not only seize large amounts of fentanyl but also arresting and building cases against violent drug traffickers bringing the deadly substance into the US.

    Outfitted with a range of surveillance gear, including infrared imaging systems and secure radio communications, the Air Force’s small fleet of RC-26 aircraft has played a prominent role in several recent operations targeting illicit shipments of fentanyl by serving as the preverbal eye-in-the sky for agents and officers on the ground, according to current and former officials.

    An agent or police officer is often on-board the aircraft to direct the pilot where to go and, working in tandem, they are able to collect information to help inform the decision-making of law enforcement officials on the ground in real time as they execute search warrants and conduct raids.

    Over the last two weeks in Arizona, the relatively obscure turboprop plane was involved in three separate fentanyl seizures of 22,500 pills each, according to law enforcement data obtained by CNN.

    Each seizure prevented 10,000 potential deaths, according to a US official familiar with the operations, who noted that the DEA says four pills in 10 have a lethal amount of fentanyl in them.

    But despite proving itself to be a valuable asset for drug interdiction, particularly at a time when the Biden administration is facing increasing pressure to stop the flow of fentanyl coming into the US from across the border, funding for the RC-26 aircraft is again on the chopping block.

    Air Force officials believe that the relatively small amount of money used to keep the current fleet of 11 RC-26 planes in the air would be better spent elsewhere. If a House amendment to provide more funding for the aircraft fails to make it through conference and is not included in Congress’ next defense spending bill, the plane will be “gone in April,” according to Kinzinger.

    The cost of maintaining all 11 RC-26s is between $25 and $31 million per year, according to a source familiar with the program, who note that is a “less than a drop in the bucket” considering the annual defense spending bill ranges in the hundreds of billions of dollars.

    Kinzinger has sent a letter to the Armed Services Committees requesting they keep the current language related to funding for the RC-26 in its next defense spending bill, which would keep the aircraft around for at least one more year and require an independent assessment of how the National Guard could replace it, with a cost analysis.

    But even if that happens, the aircraft’s long-term survival remains in question, as does the future success of the specialized missions it currently flies.

    Kinzinger is not alone in his support of the RC-26. CNN spoke with current and former law enforcement officials working in what are known as High Intensity Trafficking Areas who were adamant that the plane is a critical tool for stopping the flow of illicit drugs into the US.

    “I think of the RC-26 as my state bird,” said Rand Allison, a recently retired narcotics officer who spent over a decade working with RC-26 pilots as part of federal task forces focused on intercepting shipments of illicit drugs.

    Heightened public awareness about the dangers of fentanyl, bipartisan concerns and law enforcement statistics obtained by CNN also underscore how the RC-26 remains relevant despite claims by some air Force officials that it is too old.

    For example, data provided to CNN by the Southern Nevada High Impact Narcotics Task Force shows law enforcement agencies have used the RC-26 to seize 134,009 fentanyl pills and 15.7 pounds of pure fentanyl powder this year alone – a dramatic increase compared to the roughly 67,000 pills and 2.7 pounds of powder seized in 2021.

    In 2020, the task force documented its first seizures of fentanyl pills and powder, underscoring how the dramatic rise in law enforcement operations focused on these trafficking operations in particular.

    If the RC-26 program is ultimately scrapped, law enforcement officers would lose their best asset for dismantling trafficking operations bringing fentanyl into the US from across the border, Allison told CNN.

    The RC-26 aircraft was also used in three separate drug busts over the last three weeks where law enforcement agencies seized more than 60,000 fentanyl pills in total, according to federal drug task force data obtained by CNN.

    The first operation took place on October 18 in Las Vegas, Nevada, where the DEA seized 21,500 fentanyl pills.

    Exactly one week later, agents with the Department of Homeland Security Investigations division carried out the bust in Tucson that yielded more than 25,000 pills. The next day, a HIS team in Phoenix, Arizona seized an additional 5,000 pills and are building a much larger case, according to a law enforcement official familiar with operation.

    Still, one law enforcement official who regularly works with Air National Guard pilots to conduct counter-drug operations acknowledged feeling like they are “winning many battles but losing the war when it comes to fentanyl,” making the RC-26’s survival even more imperative.

    Over the last eight years, Kinzinger has been at the forefront of efforts to save his plane from extinction and preserve its ability to fly the type of missions that have endeared it to law enforcement officials across various agencies.

    Now, the RC-26 is again at risk of being phased out due to the shifting priorities of Air Force leaders that do not include flying border or counter-drug missions, according to the Republican lawmaker, who opted not to run for re-election but is using the final months of his time in Congress, in part, to advocate for the aircraft’s survival.

    If that happens, the Air Force will also lose more than 60 Air National Guard pilots who are trained to fly the RC-26, Kinzinger added, noting the service is already suffering from a pilot shortage.

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  • Indonesia bans sale of all cough syrups after 99 child deaths | CNN

    Indonesia bans sale of all cough syrups after 99 child deaths | CNN

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    Jakarta, Indonesia
    CNN
     — 

    Indonesia has halted the sale of all syrup and liquid medicines following the deaths of nearly 100 children and an unexplained spike in cases of acute kidney injuries.

    The ban, announced by the country’s Health Ministry on Wednesday, will remain until authorities complete an investigation into unregistered medical syrups suspected of containing toxic ingredients.

    Health Ministry spokesperson Mohammad Syahril said 99 deaths and 206 cases of acute kidney injuries in children, mostly under the age of 6, were being investigated.

    “As a precaution, the ministry has asked health workers in health facilities not to prescribe liquid medicine or syrup temporarily,” he said. “We also ask that drug stores temporarily stop all sales of non-prescription liquid medicine or syrup until our investigations are completed.”

    The ban comes after the World Health Organization (WHO) linked four Indian-made cough syrups to the deaths of up to 70 children suffering acute kidney failure in The Gambia, West Africa. Earlier this month Indian authorities shut down a factory in New Delhi where the medicines were made.

    WHO suspects that four of the syrups made by Maiden Pharmaceuticals Limited – Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup – contained “unacceptable amounts” of chemicals that could damage the brains, lungs, livers and kidneys of those who take them.

    The syrups being used in The Gambia were not available in Indonesia, according to the Southeast Asian country’s food and drugs agency.

    However, on Thursday, Indonesian Health Minister Budi Gunadi Sadikin said ethylene glycol and diethylene glycol – which are more usually found in products like antifreeze, paints, plastics and cosmetics – had been detected in syrups found in the homes of some child patients.

    “(The chemicals) should not have been present,” Budi said.

    He added that the number of acute kidney failure cases could be higher than reported and his ministry was taking a conservative approach by banning the sale of all syrups.

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  • New York City announces its largest fentanyl seizure in history, eclipsing record bust from last month | CNN

    New York City announces its largest fentanyl seizure in history, eclipsing record bust from last month | CNN

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    CNN
     — 

    Days after federal officials announced the largest fentanyl seizure in New York City history, an even greater quantity of the highly addictive substance has been found, authorities say.

    Two people have been arrested and charged with multiple drug and firearm charges in connection to the seizure on October 7 at a Bronx apartment building, prosecutors said in a news release.

    Authorities found roughly 300,000 rainbow-colored fentanyl pills inside two closets in the apartment, and more than 22 pounds of the drug in powdered form were wrapped in clear plastic packaging in multiple rooms, according to the Office of the Special Narcotics Prosecutor for the City of New York. The total sum of the drugs is worth about $9 million in street value, officials said.

    The historic seizure saved lives, according to DEA Special Agent in Charge Frank Tarentino.

    “Hundreds of thousands of lethal pills were lying in wait in a Bronx apartment to be unleashed onto our streets. In today’s world, the potential to overdose is dangerously high,” Tarentino said. “There is no quality control in these fake pills and it only takes two milligrams of fentanyl to be lethal.”

    The seizure comes after federal officials announced last week that a woman has been charged with concealing about 15,000 rainbow-colored fentanyl pills in a Lego box as part of a drug trafficking scheme in September. That seizure at the time was also deemed the largest of fentanyl in New York City’s history.

    Fentanyl is a synthetic opioid that’s highly addictive. It can be up to 50 times stronger than heroin and 100 times stronger than morphine, the US Centers for Disease Prevention and Control said.

    Rainbow fentanyl comes in bright colors and can be used in pill form or powder.

    “Rainbow fentanyl is the latest threat we face in our fight against the opioid epidemic that sadly continues to ravage our communities – a multi-colored poison specifically designed to attract younger users,” Nassau County District Attorney Anne T. Donnelly said.

    And as Halloween nears, officials have been warning families to be especially vigilant regarding their children’s candy before they consume it.

    The dangerous drug has been a major driver of fatal and nonfatal overdoses in the US as well as the opioid epidemic.

    Although there has been a slight decrease in recent months in drug overdose deaths, the numbers remain high. About 108,000 people died of a drug overdose in the 12-month period ending May 2022 – which is down from the record high of more than 110,000 deaths reported in the 12-month period that ended March 2022, CDC provisional data published Wednesday shows.

    The latest overdose death figure remains 32% than it was two years earlier and higher than any other period before November 2021, according to the CDC data. Synthetic opioids, including fentanyl, were involved in more than two-thirds of deaths in the 12-month period ending May 2022, and psychostimulants were involved in nearly a third.

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  • Three GOP appointees, including 2 from Trump, will hear the next phase of major abortion pill case | CNN Politics

    Three GOP appointees, including 2 from Trump, will hear the next phase of major abortion pill case | CNN Politics

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    CNN
     — 

    The New Orleans-based appeals court panel that will oversee the next stage in the blockbuster legal challenge to the availability of medication abortion drugs is made up of three Republican appointees, including one Trump nominee who has called abortion a “moral tragedy.”

    Circuit Judges James Ho and Cory Wilson, both Trump nominees, will hear the oral arguments on May 17, alongside Judge Jennifer Walker Elrod, an appointee of George W. Bush.

    The lawsuit was brought by anti-abortion doctors and medical organizations who allege the US Food and Drug Administration broke the law when it approved the medication abortion drug mifepristone more than two decades ago.

    Last month, US District Judge Matthew Kacsmaryk agreed with their arguments and ruled that the approval of the drug should be suspended. 

    However, his ruling was put on hold by the Supreme Court on April 21 and it will remain on hold until the case goes back to the high court, regardless of how the 5th US Circuit Court of Appeals rules on the merits.

    Ho, a former Texas solicitor general, is considered one of the most conservative and strident members of the 5th Circuit, having described abortion as a “moral tragedy” in a 2018 concurring opinion.

    In a 2019 concurring opinion, Ho also said that a trial judge’s ruling – which struck down a 15-week abortion ban and which was affirmed by the 5th Circuit under the then-standing Roe precedent – displayed “an alarming disrespect for the millions of Americans who believe that babies deserve legal protection during pregnancy as well as after birth, and that abortion is the immoral, tragic, and violent taking of innocent human life.”

    The 5th Circuit is considered one of the most conservative in the country has consistently ruled against the Biden Justice Department.

    Wilson earlier this year wrote a majority circuit opinion that said that a federal law that bars gun ownership by people under domestic violence was unconstitutional.

    Elrod penned an opinion last month that struck down the federal ban on bump stocks, which are attachments that essentially allow shooters to fire semiautomatic rifles continuously with one pull of the trigger.

    The medication abortion case is another hugely consequential case to go through the circuit. Mifepristone – the drug being targeted in the lawsuit – is the first pill in the two-pill regimen for terminating a pregnancy. Medication abortion makes up more than half of all abortions obtained in the United States.

    In filings last week, the Justice Department told the 5th Circuit that Kacsmaryk’s conclusions that the drug was unsafe rested “on a series of fundamental errors.”

    “While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies, offering demonstrably erroneous characterizations of the record,” the DOJ’s filing said. 

    The department’s opponents in the case will file a response later on Monday.

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  • Biden administration moves ahead with Medicare drug price negotiations amid industry lawsuits | CNN Politics

    Biden administration moves ahead with Medicare drug price negotiations amid industry lawsuits | CNN Politics

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    CNN
     — 

    Undeterred by a growing number of lawsuits, the Biden administration on Friday released revised guidance for Medicare’s new drug price negotiation program.

    The latest guidance outlines how the Centers for Medicare and Medicaid Services will negotiate with drugmakers to reach agreement on a maximum fair price for a selected medicine, the agency said. It was informed by public input on the initial guidance the agency released in March, which explained how it will select the drugs and how the negotiations will be conducted.

    The program, which was authorized by the Inflation Reduction Act that congressional Democrats passed last year, has prompted a fierce backlash from the pharmaceutical industry. Two drug manufacturers and two industry groups have filed lawsuits, arguing the measure is unconstitutional.

    But the administration is not backing down from implementing its historic new power. It intends to keep its timeline of announcing the first 10 drugs that will be selected for negotiation by September 1. CMS and the drugmakers will negotiate during 2023 and 2024. The prices will be effective starting in 2026.

    “The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” Secretary of Health and Human Services Xavier Becerra said in a statement. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred.”

    The initial set of drugs will be chosen from the top 50 Part D drugs that are eligible for negotiation that have the highest total expenditures in Medicare. CMS will consider multiple factors when developing its initial offer, including the drugs’ clinical benefits, the price of alternatives, research and development costs and patent protection, among others.

    If drugmakers don’t comply with the process, they will have to pay an excise tax of up to 95% of the medications’ US sales or pull all their drugs from the Medicare and Medicaid markets. The pharmaceutical industry contends that the true penalty can be as high as 1,900% of sales.

    CMS said it received more than 7,500 comments on its initial guidance from patient groups, drug companies, pharmacies and others.

    The changes it is making are aimed at improving transparency while keeping confidentiality in mind, as well as fostering “an effective negotiation process,” the agency said.

    They include revising the confidentiality process to state that CMS will release information about the negotiations when it publishes the explanations of the prices. Also, drug companies may publicly discuss the negotiations – the prior secrecy requirement had been a point of contention among manufacturers that was mentioned in the lawsuits. And they won’t be required to destroy data relating to the negotiations.

    In addition, CMS will hold patient-focused listening sessions to provide drug companies and the public more opportunities to engage with the agency. The sessions – which will give patients, caregivers and others the chance to share input on how a medication addresses unmet needs, how it impacts specific populations and what therapeutic alternatives exist – will be held in the fall for the first round of drugs.

    Merck, Bristol Myers Squibb, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, and the US Chamber of Commerce have all recently filed lawsuits in federal courts across the US. They each argue the program is unconstitutional in various ways.

    The challengers also say that the negotiation provision will harm innovation and patients’ access to new drugs.

    Among the arguments are that the program violates the Fifth Amendment’s “takings” clause because it allows Medicare to obtain manufacturers’ patented drugs, which are private property, without paying fair market value under the threat of serious penalties.

    Plus, the negotiations process violates the First Amendment, the challengers say, because it coerces manufacturers into saying that they agree to the price that the government has dictated and that it’s fair.

    Another argument is that the process violates the Eighth Amendment by levying an excessive fine if drugmakers refuse to negotiate and continue selling their products to the Medicare market.

    Merck expects its diabetes drug Januvia to be among the drugs named in September and its blockbuster cancer treatment Keytruda and diabetes drug Janumet to be subject to negotiation in the future. Bristol Myers Squibb believes its blood thinning medication, Eliquis, will be subject to negotiations this year, and its cancer medication, Opdivo, will be selected in a subsequent round.

    The changes in the revised guidance did not allay the complaints of the pharmaceutical industry. PhRMA said that transparency remains “severely limited,” patients’ views are not being taken into account and Medicare beneficiaries could have less access to drugs.

    “The very few substantive changes to the final guidance demonstrate CMS saw this as a box checking exercise, not an opportunity to mitigate the negative impacts this price setting policy will have on patients or the broader health care sector,” PhRMA said in a statement.

    “The approach CMS took in this final guidance confirms what we claimed in our lawsuit – Congress’ unconstitutional shortcuts taken in the law have given the administration far too much flexibility to set prices at their whim without any oversight or accountability to anyone,” the group continued.

    The Biden administration will “vigorously defend” the drug price negotiation program, said CMS Administrator Chiquita Brooks-LaSure.

    “We feel the law is on our side,” she said in a call with reporters Friday.

    This story has been updated with additional information.

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  • Top Treasury sanctions official to visit southern border as it ramps up efforts to crack down on deadly fentanyl trade | CNN Politics

    Top Treasury sanctions official to visit southern border as it ramps up efforts to crack down on deadly fentanyl trade | CNN Politics

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    CNN
     — 

    Treasury’s top sanctions official Brian Nelson will travel to the southern border Tuesday as part of the department’s ongoing push to crack down on the cartels and illicit financial networks fueling the deadly fentanyl trade, Treasury officials told CNN.

    Nelson’s trip – his second in sixth months – and a spate of recent sanctions activity is the latest indicator that Treasury is ramping up efforts to tackle the illegal fentanyl trade through actions that disrupt the supply chains funneling “precursor” chemicals from China to producers in Mexico where much of the deadly drug is made.

    Nelson and Treasury officials will meet with fellow law enforcement representatives, including from the Department of Homeland Security and U.S. Customs and Border Protection, as well as private financial institutions and local officials.

    “What we are doing is trying to be as effective as we possibly can in combining Treasury’s tools with the efforts that other US government agencies and allied governments are deploying in this space,” said Nelson, the under secretary for terrorism and financial intelligence at Treasury, in an interview with CNN.

    The engagements over the 48-hour trip will provide officials an opportunity to discuss how Treasury’s tools and information can complement law enforcement and to learn about the big issues and patterns that agents are seeing on the ground. The trip is also aimed at exploring how trends and information from the extensive financial information Treasury collects can be helpful to the broader government-wide effort to quell the synthetic opioid epidemic.

    Nelson, who will also be joined by the acting director of the Financial Crimes Enforcement Network (FinCEN) Himamauli Das, will visit Laredo and San Antonio in Texas on Tuesday and Wednesday.

    In Laredo, Nelson will receive briefings on border operations from CBP officials at the city’s port of entry as well as discuss cargo processing and inspections.

    “There’s a credible value in seeing that in person,” Nelson said.

    In San Antonio, Nelson and Das will host a “FinCEN Exchange,” which is a public-private information sharing forum where Treasury can share the different patterns and connections they’re seeing with financial institutions, as well as discuss further ways the federal government can partner with the private sector to better spot red flags and identify illicit financial networks.

    The department has been involved in the counter-narcotics business for decades, using its tools and financial expertise to both starve criminal organizations of critical financing through sanctions and blocking assets, as well as providing crucial financial data to other law enforcement and federal agencies.

    “We can help disrupt financial flows and target the whole supply chain, starting with the precursor chemicals all the way down to distributors bound for US markets. And it’s not just sanctions,” Nelson said, pointing also to FinCEN’s financial mapping tools as well as Treasury’s focus on cooperating with Mexico to improve their capacity to trace and combat illicit finance.

    “These tools, combined with financial mapping that our FinCEN team does, is very, very powerful insight,” he added.

    Investigators from the Treasury, especially those at FinCEN, can access and share powerful financial data with enforcement bodies like the Drug Enforcement Agency, the Department of Homeland Security and others as they work to track and disrupt the fentanyl trade and drug suppliers.

    Nelson also said that Treasury is “absolutely” looking to build on US Secretary of State Antony Blinken’s latest engagements in China, which included discussing where the two nations could cooperate on curbing the flow of precursor chemicals from China. Blinken, who traveled to Beijing last month, said both sides agreed to “explore” establishing a working group on the precursor chemicals used to produce the deadly synthetic drug.

    There has been a government-wide push to curb synthetic opioids like fentanyl, which are the main driver of overdose deaths in the US. According to the US Centers for Disease Control and Prevention, there has been a more than seven-fold increase overall in deaths from 2015-2021, and despite a recent slowing, overdose deaths still hover near record levels and remain the third leading cause of death in adolescents aged 19 and younger.

    In April, the Biden administration announced a broad effort to target the production and distribution of fentanyl, which included criminal charges from the Department of Justice and a host of new Treasury sanctions.

    It was an announcement that built off of an executive order signed in 2021 that expanded Treasury’s authorities to target the distribution chains of fentanyl and other narcotics, which Nelson said has been critical to helping Treasury “increase the pace at which we are able to target and designate the key nodes in fentanyl distribution.”

    Since then, Treasury has continued to issue sanctions against precursor chemical supply networks, particularly in China, as well as other corrupt activity like arms trafficking and money laundering that helps support the trade.

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  • There aren’t enough facilities to treat all kids hooked on opioids | CNN Politics

    There aren’t enough facilities to treat all kids hooked on opioids | CNN Politics

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    A version of this story appears in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here.



    CNN
     — 

    After writing several previous newsletters on the stunning rise in opioid overdoses in the US, including among adolescents, I thought it was worth taking a look at what happens after an overdose, particularly for adolescents.

    I talked to Dr. Sivabalaji Kaliamurthy about what he’s encountering. A child and adolescent addiction psychiatrist who is board certified in general psychiatry, child psychiatry and addiction psychiatry, Kaliamurthy is also the director of the addiction clinic at Children’s National Hospital in Washington, DC.

    He told me that his clinic, which he set up in early 2022, has gone from getting one or two opioid use referrals per month to eight or more per month now, a year later.

    He particularly wanted to discuss some major news: The opioid overdose antidote naloxone, sold as Narcan, got approval from the US Food and Drug Administration on March 29, the day we talked, to be sold over the counter.

    Excerpts from our conversation, edited for flow, are below.

    WOLF: What is your reaction to Narcan being available over the counter?

    KALIAMURTHY: When I do an evaluation (of a patient), regardless of the substance use, you’re always talking about naloxone, brand name Narcan. …

    The message that I present parents with is always that it’s kind of like having a fire extinguisher at home. You hope you never need to use it, but you’re glad that you have it if you need to use it.

    Access is important. There are some controversies around increasing access to naloxone and fears that this may encourage more substance use. We have scientific research looking into this very specific question.

    And overall, there’s one study that came out this month that found that across 44 states where they increased access to naloxone for adolescents, it did not increase the rates of substance use in this population. And in some states, it actually decreased opioid use among adolescents. …

    The FDA approved the over-the-counter sale of naloxone, specifically the brand Narcan, because of how easily it can be administered. Naloxone also comes in other formulations, like injections, but Narcan is a nasal spray. We’re hoping that it will be out later this summer.

    The challenge remains how much is it going to cost? On average, it can cost anywhere between $50 to $100 right now. If it becomes over-the-counter, we don’t want insurances to stop covering [it].

    It will be interesting to see how the manufacturer goes about introducing it over the counter.

    WOLF: You said it’s like a fire extinguisher. Should everybody have it, or just people whose kids have demonstrated addictive behavior?

    KALIAMURTHY: Everyone should have it. Naloxone is not a treatment; it is more of an antidote. It reverses opioid overdoses, and the person who has the opioid overdose is never the one who’s going to use it somewhere in the community.

    WOLF: I’ve reported on a surge in overdoses. What are you seeing at Children’s?

    KALIAMURTHY: We are seeing an increase in the number of kids presenting to the hospital after experiencing an opioid overdose, and in general, opioid overdose deaths in the DMV (Washington, DC, Maryland, Virginia) region have significantly increased in the last two years. That aligns with a national trend we are seeing with regards to opioid overdoses.

    WOLF: Is there a profile for who these kids are? Do they share any traits?

    KALIAMURTHY: Yes. Let me talk about the kids we do see for opioid-related concerns first.

    At Children’s National, children often present after experiencing an overdose or having a medical complication because of using these M30, or the fake Percocet pills. We’ve had kids come in following conditions such as preliminary hemorrhage, where they were bleeding into their lungs, and overdose is not the only concern.

    Apart from that, we also have had kids presenting actively using these pills. They haven’t overdosed yet but they’re asking for help to stop using these pills.

    Some things that we have noticed, and this is the trend across the DMV region … the kids who are presenting to treatment, these are kids who are motivated to stop – they predominantly identify as Hispanic in ethnicity. Most of them have Medicaid for insurance.

    A lot of them, you know, they come to us – the average age is about 16, 16½ and their first use of opioids, these pills, was about a year ago. So the average first use was about 15 to 15½ years of age. They are really struggling, and they want to get better.

    KALIAMURTHY: Another common trait: cannabis use is quite common in this population. Pretty much every patient that I’ve come across started off around age 12 using cannabis products. This includes the flower and bud, vapes or edibles. Soon they transition to using the M30 pills.

    There are various different reasons, one of which is just access. A lot of other kids are using it. They’re using it in schools. They try it, they like it, and then it escalates and they stop using other substances.

    Most of these kids start off with crushing and try it nasally by snorting it and then they transition to smoking. What they do is they put these pills on a piece of aluminum foil, heat it up and inhale the fumes that come up. We haven’t had anyone come in who reported using any of these pills intravenously.

    WOLF: How is treatment for adolescents different than treating adult users who are seeking help?

    KALIAMURTHY: We have to take into consideration their developmental age and the psychological development that’s happening in adolescence, which is very different from adults.

    Oftentimes, this is the first point of entry into opioid use for these kids. Fentanyl, which is one of the most powerful opioids of abuse out there, is the first point of entry into opioid use for these children.

    Where for adults, they might have been prescribed pain medications. Or they might have started on opioids through other routes and might have used less potent products before transitioning to fentanyl.

    KALIAMURTHY: Historically, adolescents were not always the most motivated to seek treatment for substance use. What we would see was they would start off with experimenting, there would be a problem, it would take a few years and they’re adults by the time they’ve entered treatment and they’re trying different things to treat themselves before they enter treatment.

    With adolescents, now we are seeing that they can tell that they need help, and they are motivated and they are entering treatment.

    We have to take into account the presence of parents or guardians, how the school system interacts with them, what else do they do in their communities. There’s an increased association of violence and legal trouble that some of these patients end up in that we need to address while treating them. And these are some differences when it comes to treating adolescents versus adults.

    WOLF: One local community’s opioid response coordinator stressed to me that lack of availability of treatment is a real problem. Is that something that you agree with?

    KALIAMURTHY: Absolutely. That is a real problem at this point, because there is a huge discrepancy between the number of kids who need treatment and the available resources.

    The challenge is we can limit access and prevent these kids from getting the pills. But then you have a huge population of kids who are dependent on these pills, who can’t tolerate withdrawal symptoms, who have what we call opioid use disorder. That is going to perpetuate the problem if we’re not treating them. We need to do more in terms of increasing access to care for these kids.

    WOLF: Can you illustrate that capacity issue for me, through numbers or data? Or is it more anecdotal?

    KALIAMURTHY: Treatment is across different realms.

    For example, when a child is using these pills, and they have a problem with substance use, they need to go and be evaluated by a professional who has expertise in both addressing and evaluating mental health and addiction problems. And we don’t have very many people being able to do that.

    KALIAMURTHY: The first-time response is usually a counselor or social worker, sometimes physicians.

    But generally, there’s very little expertise in the pediatric health space with regards to addressing substance use-related problems. Screening is the point of entry.

    KALIAMURTHY: Then, say they need detox beds. Once they’ve entered treatment, we want to help them get through those initial days when their body is kind of adjusting to not using these pills, and we refer to that as detox.

    At Children’s National Hospital, when the kids come to the emergency room, we are not able to admit them for detoxes all the time. Sometimes we do end up admitting them.

    This depends on the availability of beds. The number of pediatric beds is very small to begin with. And beds may not always be available when somebody presents to the emergency room detox.

    And then there’s who is on call? Who’s available to treat these kids? I spoke about the lack of expertise in general, across the pediatric health space, so all that will determine whether a child is able to get access to detox services.

    That’s the detox part of treatment, which can be anywhere between two to five days.

    Detox doesn’t always mean somebody needs to be admitted. I also do outpatient detox where we are helping kids stop by providing them with medications and guiding their parents or guardians and the child on how to go through detox.

    KALIAMURTHY: Once you go through detox, depending on the extent of the problem, a child may require admission to a rehabilitation facility for anywhere between a month to six months.

    When we look at the number of facilities in the DMV region that provide this kind of rehab, I don’t think Virginia has any, DC doesn’t have any, Maryland has two. One is Sandstone Treatment Center, which is a private institution. The other is a treatment center, which is closer to Baltimore. There’s a limitation on who they can take.

    WOLF: Let me interrupt you. In a region that has millions of people, there are only two facilities that will take adolescents for one to six months’ treatment for substance use?

    KALIAMURTHY: Yes. For substance use.

    WOLF: Is that just a function of there’s more demand for those kinds of facilities among older people who are more likely to face addiction problems? Is that something the system is pivoting to address right now?

    KALIAMURTHY: It’s unclear. The system wants to help, but the challenge is historically adolescents are not always the most eager and motivated to get help.

    When we look at treatment programs, that didn’t exist in the past. They often relied on the judicial system, where some of these kids might have been mandated to treatment.

    Now we know that substance use disorders are chronic disorders and mandates don’t always work. Courts have stopped mandating treatment, because it’s like you mandate it for a month and then they come out and then what happens? There’s a lot of issues with mandating treatment.

    Now, most of the programs that were present prior to the pandemic also shut down during the pandemic because the needs also declined.

    This is not financially lucrative. That’s one reason why they’re having a huge issue with finding systems and having the county or the state take over with regards to creating the system.

    WOLF: I cut you off there. You were moving from the one-to-six-month facility to the next step in the process.

    KALIAMURTHY: So the next step is really engaging these kids in treatment. Not all kids require one to six months. Some kids might be OK with just completing detox and engaging in regular outpatient level of care. This might involve what we call intensive outpatient combined with medication.

    Which is where I would come in. A lot of what I do is provide medications for addiction treatment. These medications, the first part is for the detox to help with the child’s symptoms, but once you go through withdrawals, you can still have significant cravings to go back to using.

    The challenge, again, is the number of facilities. There are more options for intensive outpatient, but again, they are packed. The wait times to get in are longer now, and some of them are just virtual-only options, which may be good for some kids, but some kids might need more inpatient help.

    KALIAMURTHY: After this step, we have regular outpatient therapy and recovery support services, which is also lacking.

    The recovery support services are services which help kids get back on track academically. Catch up with your credit, get up on your grades and form a healthy, functioning resume. Get help finding part-time jobs. Keep these kids engaged in activities outside of school so that they are less likely to go back to the path that they were on which led to the substance use.

    WOLF: What’s your message to parents who are trying to keep an eye on their kids?

    KALIAMURTHY: Let’s look at the national-level data that we have collected up to 2021. Substance use is actually on the decline.

    Which is interesting because what is happening is that even though substance use among kids is on the decline – that’s both in middle school and high school – the substances that kids are using have become so much more potent.

    Take cannabis, which if you measure the potency by the percentage of THC content, has gone up significantly. The average THC percentage in the ’60s and ‘70s was like 2-5%. And now it’s like 20-25%. And kids are more likely to use what they call the concentrates, which is like 80% or more THC.

    When I talk to parents, the first thing I’m telling them about is the landscape of different substances that are out there, and kids are more likely to start off with cannabis or alcohol before they transition to the M30 pills.

    KALIAMURTHY: If you think about modifiable and non-modifiable risks, some risks just cannot be changed. These are things like genetics, family history and also if a child has a history of any traumatic experiences. Those are not things you can necessarily change. There are modifiable risk factors, like if a child has ADHD, they’re more likely to be at risk for developing substance use problems.

    If there are untreated mental health conditions, such as depression, anxiety, they’re more likely to have problems. We know that. The kids who identify as LGBTQ+, they also tend to have more risk factors in terms of initiating substances that transition into a problem.

    But also, we need to rethink how families address substances in the household. Kids learn by modeling they see from adults in their life and also the direct conversations we have. What are their values as a family around use of substances? These are not just legal and illegal – all substance use can have some harm. And early initiation is going to lead to more likelihood of having a problem.

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  • HHS secretary says ‘everything is on the table’ amid calls to ignore medication abortion ruling | CNN Politics

    HHS secretary says ‘everything is on the table’ amid calls to ignore medication abortion ruling | CNN Politics

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    CNN
     — 

    Health and Human Services Secretary Xavier Becerra on Sunday said “everything is on the table” following a Texas federal judge’s ruling to suspend the Food and Drug Administration’s approval of the medication abortion drug mifepristone.

    In an interview with CNN’s Dana Bash on “State of the Union,” the secretary would not say whether he believes the FDA should ignore the ruling and keep the drug on the market, but he maintained that the Biden administration is considering all options.

    “We want the courts to overturn this reckless decision,” Becerra said, adding that there was a “good chance” of Supreme Court intervention but declining to say how, exactly, the administration will handle the ruling in the interim.

    “Everything is on the table. The president said that way back when the Dobbs decision came out. Every option is on the table,” the secretary told Bash, referring to last year’s Supreme Court ruling that overturned Roe v. Wade.

    Democratic Rep. Alexandria Ocasio-Cortez, in a separate appearance on “State of the Union,” did not back away from her call Friday on CNN for the ruling to be ignored, saying that if it was ultimately upheld by the Supreme Court, “it would essentially institute a national abortion ban.”

    “I do not believe that the courts have the authority over the FDA that they just asserted, and I do believe that it creates a crisis,” she told Bash.

    Ocasio-Cortez called the ruling “an extreme abuse of power” and said there was precedent for the executive branch ignoring court rulings.

    “I do think that when it comes to gaming out what the very real possibilities are in the coming days, weeks and months, this is not just about speculation, but this is about preparation. And the reality of our courts right now is very disturbing,” she said.

    Meanwhile, Republican Rep. Tony Gonzales of Texas warned in a separate interview with Bash on Sunday that House GOP appropriators could defund certain FDA programs if the ruling is ultimately ignored.

    “The House Republicans have the power of the purse, and if the administration wants to not lead this ruling, not live up to this ruling, then we’re going to have a problem,” the second-term lawmaker said. “And it may come a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense.”

    US District Judge Matthew Kacsmaryk on Friday issued a ruling to halt the decades-old approval of mifepristone, but he paused the ruling from taking effect for a week so it could be appealed, a process that is underway.

    “This is not America,” Becerra said Sunday. “What you saw is that one judge in that one court in that one state, that’s not America. America goes by the evidence. America does what’s fair. America does what is transparent, and we can show that what we do is for the right reasons. That’s not America.”

    Within an hour of the ruling Friday, a different federal judge ruled in favor of 17 Democratic-led states and Washington, DC, looking to expand access to the abortion pill, allowing them to keep the drug available.

    Becerra on Sunday touted the proven safety of the drug, a factor that Kacsmaryk questioned in his ruling. He confirmed that the Department of Justice had already filed its appeal and is waiting for its day in court.

    Still, Becerra had little to say about what tangible preparations the administration would take to secure access to abortion should the drug no longer be available after the weeklong pause.

    “Well, [women] certainly have access today, and we intend to do everything to make sure it’s available for them not just in a week but moving forward, period,” Becerra told Bash when asked if women would have access to the medication after this week.

    The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, have both filed notices of appeal. Attorney General Merrick Garland and Danco said in statements that in addition to the appeals, they will seek “stays” of the ruling, meaning emergency requests that the decision remains frozen while the appeal moves forward.

    They’re appealing to the 5th US Circuit Court of Appeals, which is sometimes said to be the country’s most conservative appellate court. Yet some legal scholars are skeptical that the 5th Circuit, as conservative as it is, would let Kacmsaryk’s order take effect.

    “I got to believe that, Dana, an appeals court, the Supreme Court, whatever court has to understand that this ruling by this one judge overturns not just access to mifepristone, but possibly any number of drugs,” Becerra said.

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  • Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug | CNN Politics

    Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug | CNN Politics

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    CNN
     — 

    The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs.

    Now that the filings have been submitted, the US 5th Circuit Court of Appeals Court could rule at any time on whether to put a hold on the order from US District Judge Matthew Kacsmaryk.

    Kacsmaryk on Friday night said he was halting the FDA’s approval of the drug mifepristone but that he was delaying the order by seven days to give the pill’s defenders time to appeal the case. The Justice Department has asked the appeals court to act by 12 p.m. CT Thursday on its request that Kacsmaryk’s ruling be paused, to give the government time to seek a Supreme Court intervention if need be. The 5th Circuit is not obligated to meet that deadline.

    The Justice Department wrote in its new filing that Kacsmaryk purported “to be acting in a restrained manner … but there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug.”

    “Effectively requiring Danco Laboratories and GenBioPro to cease distribution of mifepristone after more than two decades would upend the status quo, severely harming women, healthcare systems, and the public,” the Justice Department said, referring to the two US manufacturers of mifepristone.

    The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department also called out Kacsmaryk and the challengers for relying on anonymous blog posts to claim mifepristone is unsafe.

    Danco Labroratories, which intervened in the case to defend mifepristone’s approval, wrote in its new filing with the appeals court that if the ruling is not frozen, “women across the nation will face serious, unnecessary health risks from the elimination of access to a drug FDA has repeatedly deemed safe and effective and that is the standard of care.”

    In an overnight filing, the anti-abortion doctors who sued to ban medication abortion drugs told a federal appeals court that it should leave in place the ruling that will halt the drug’s FDA approval.

    The anti-abortion doctors defended Kacsmaryk’s ruling called it a “meticulously considered” ruling that “paints an alarming picture of decades-long agency lawlessness – all to the detriment of the women and girls FDA is charged to protect.”

    Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations have rebuked the claims by the approval’s legal challengers and by the judge that the drug is unsafe.

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  • Justice Department asks Supreme Court to intervene in abortion drug ruling | CNN Politics

    Justice Department asks Supreme Court to intervene in abortion drug ruling | CNN Politics

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    CNN
     — 

    The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge’s medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.

    The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration’s authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.

    Solicitor General Elizabeth Prelogar said in the filing that it “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”

    She said that if the ruling were allowed to stand it would “inflict grave harm on women, the medical system, the agency, and the public.”

    Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide.”

    “The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attonrey, Jessica L. Ellsworth, told the justices.

    The clock is ticking. If the Supreme Court does not step in, the district court’s ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.

    Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.

    The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA’s 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.

    Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.

    The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.

    The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off-label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

    Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA’s expert judgment should not be challenged.

    “FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” she wrote, reminding the justices that currently, “more than half of women in this country who choose to terminate their pregnancies rely on mifrepristone to do so.”

    She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. That is because, she said, they neither “take nor prescribe” the drug, and the FDA’s approval “does not require them to do or refrain from doing anything.”

    CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the 5th Circuit’s ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.

    “The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”

    Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.

    In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

    A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.

    The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

    The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.

    This story has been updated with additional developments.

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