Latest news with #FoodandDrugAdministration
The Hill
11 hours ago
- Health
- The Hill
Missouri AG sues Planned Parenthood for allegedly lying about dangers of abortion drugs
Missouri is suing Planned Parenthood for allegedly lying to patients about the risks of the abortion medication mifepristone. Missouri Attorney General Andrew Bailey (R) filed a lawsuit Wednesday in Jefferson City arguing that Planned Parenthood's claims that the abortion drug is safer than many other medications including penicillin and Tylenol are untrue and violate the state's consumer-protection law. Bailey claims that the nonprofit organization has lied about the safety of the drug to 'cut costs and boost revenue,' according to the lawsuit. The complaint also requests a court order to stop Planned Parenthood from 'continuing to promote the falsehoods,' in Missouri and for the organization to pay more than $1.8 million in civil penalties. The attorney general's office is also asking for the organization to be fined $1,000 in damages to every woman in the Show-Me State that has received abortion medication through one of is providers in the past five years. On top of this, it asks that the organization reimburse the state for Medicaid and other tax-payer-funded emergency care provided to people who suffered complications after taking mifepristone. 'We are going to hold these charlatans and death dealers accountable,' Bailey wrote in a post on social platform X about the suit. The crux of the lawsuit's argument comes down to a disagreement over how many people suffer adverse health effects after taking mifepristone. On the Food and Drug Administration's (FDA) warning label for the drug, it states that between 2.9 percent and 4.6 percent of people who have taken it along with misoprostol report visiting an emergency room afterwards. There are two drugs typically needed for a medication abortion: mifepristone and misoprostol. Mifepristone stops the pregnancy from growing while misoprostol induces cramping and bleeding to empty the uterus. More than 100 scientific studies across decades have looked at the efficacy and safety of the pair and all of them have found the drugs safe for use, according to an analysis from The New York Times. Bailey's lawsuit claims that the FDA's label is inaccurate and that 'recent studies' suggest the complication rate is much higher. The lawsuit does not cite a specific study to back up its claim and a spokesperson for the attorney general's office did not answer questions from The Hill about what data was used to back up its claim. The lawsuit does echo findings outlined in a deeply flawed study published in April by the conservative think tank the Ethics and Public Policy Center (EPPC) which states that after analyzing more than 865,000 prescribed mifepristone abortions, it determined that nearly 11 percent of women experienced a 'serious adverse event.' That's nearly 22 times higher than what the FDA reports. Bailey's lawsuit references a 'dataset' of more than 850,000 mifepristone abortions that identified 'serious adverse events' in more than 10 percent of women who took the drug. Medical researchers have criticized the EPPC study for its lack of transparency and for flaws in its methodology. One of the largest hiccups of the study is its inclusion of emergency room visits as one of the 'serious adverse events' that can happen after taking the abortion pill, health experts say. The EPPC study breaks down 'serious adverse events' into categories including hemorrhage, sepsis and emergency room visits. It looks as if emergency room visits were counted as adverse events even if health care workers determined the patient was healthy and released them without treatment. Some people might go to an emergency room after taking the abortion pill to confirm that they are no longer pregnant or to make sure that the bleeding they are experiencing is normal, two principal research scientists at the Guttmacher Institute noted in an op-ed last month. The lawsuit is the latest attack from conservative lawmakers on Planned Parenthood. Under the GOP's new tax and spending bill, the organization would lose its ability to receive Medicaid reimbursements for health services it provides for one year. The nonprofit sued the Trump administration over the provision and a federal judge granted the organization's request for a temporary injunction earlier this week.
Yahoo
11 hours ago
- Health
- Yahoo
Summer Covid cases are rising across the U.S. — Is it time for a vaccine?
As Covid cases begin to rise this summer, many may be wondering: What are my risks, and is it time to get another vaccine? As of July 15, Covid cases were growing or likely growing in 27 states including Texas, Illinois, Kentucky, Virginia and Ohio, according to the Centers for Disease Control and Prevention. Rates of positive Covid tests have also been increasing in recent weeks, the CDC says, specifically in the southern region of the country. N.B.1.8.1 is the current dominant variant in the United States, accounting for 43% of all new Covid cases, according to the CDC. It's an offshoot of the XVD.1.5.1 strain, a descendant of the omicron variant. N.B.1.8.1 was responsible for a surge in hospitalizations in China earlier this year. It's been nicknamed 'razor blade throat,' as there have been anecdotal reports of some people getting painful sore throats, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee. Schaffner noted, however, that sore throats have been a common symptom of Covid since it first began spreading. 'I doubt the clinical spectrum of Covid has changed substantially,' Schaffner said. Do I need a Covid booster? When will the new vaccines be available? The uptick in cases comes as many Americans have likely gone a year or longer without a Covid shot. In May, the Food and Drug Administration asked drugmakers to update their Covid vaccines to target the LP.8.1 strain, a descendent of JN.1, which began spreading widely in 2023 and is another offshoot of omicron. LP.8.1 currently accounts for 31% of all new cases, per the CDC. The new shots won't be available until the fall, and are expected to be approved only for adults 65 and up and kids and adults with at least one medical condition that puts them at risk of severe illness. Healthy kids and adults who want a shot may have to find an older version or pay out of pocket. A single dose can cost as much as $140. Experts say, however, that population immunity — whether from vaccination, prior infection or both — may shield much of the public for now. 'While we don't have a lot of high level of immunity in the population right now, because it's been so long, we may have enough low level immunity to just make it a little bit harder for that virus to transmit easily from person to person,' said Andy Pekosz, an infectious disease researcher at Johns Hopkins University. Indeed, weekly hospitalization rates have remained low, suggesting that the new variant may not be leading to severe illness. The number of cases are still drastically lower than those this time last year, when the test positivity rate peaked in August at 17.9%. The 2025 season has yet to scrape 5%. Pekosz said it isn't unusual for cases to rise during the summer time, when people are likely to crowd indoors to escape the heat. However, he believes that if there is a summer surge of cases, it will be a small one. 'The variants have been around for a while and haven't caused any major surges up until date,' Pekosz said. 'So again, I'm hopeful that if we see a surge, it'll be a low level surge compared to previous years.' Dr. Ofer Levy, director of the precision vaccines program at Boston Children's Hospital, who has advised the FDA, said people who are at high risk of severe illness still may want to consider getting a Covid shot, if they can find one. High risk groups include: Older adults People with weakened immune systems Pregnant women Those with underlying health conditions, such as asthma and heart disease Getting a shot is especially important, Levy said, for those who haven't had one in over a year and whose immunity has likely waned. 'If you're in a high risk group and you're in a state where cases are rising, you may want to just get the first available appointment and get a shot to protect yourself,' he said. People at high risk can then consider getting an additional Covid shot when the updated vaccines are distributed in the fall, he said. Covid has two waves a year Schaffner, of Vanderbilt, said people in the high risk groups may also want to consider wearing a mask during indoor activities, such as the movies. Healthy adults and children may be able to wait longer before getting another shot, Levy added. 'If you're in a lower risk group, that's where things get fuzzy,' he said. 'I mean if you want a vaccine and your health care provider concurs and you can get it.' Dr. Michael Phillips, an infectious disease doctor at NYU Langone, said that he sees mostly immunocompromised and older adults test positive for the virus. For those who haven't gotten a Covid shot in years, Phillips said he doesn't think they should worry just yet. 'If you're younger, otherwise healthy, I think you're OK,' Phillips said. 'If you have underlying pulmonary disease, you know, if you're an older age group, now that's a time when you should be really talking to a doctor and saying, 'Gosh, should I be getting a booster for Covid?'' He said that the amount of positive Covid tests NYU Langone has seen has decreased 40% since February. Fatima Amaeka, a senior analyst at the Center for Outbreak Response Innovation at Johns Hopkins, said she expects the current wave to peak around September. Schaffner said to expect another wave in the late fall and winter. '[Covid] has two increases each year,' he said. 'Everyone is familiar with the winter increase that goes along with flu and RSV.' This article was originally published on Solve the daily Crossword
Politico
12 hours ago
- Business
- Politico
Trump's new AI action plan
OPERATING ROOM President Donald Trump's announcement Wednesday about his plans for artificial intelligence include a push to grow AI adoption in health care and across the federal government by testing it in regulatory free zones. The White House AI Action Plan says the government should set up regulatory sandboxes, or regulation-free environments, where AI can be tested in real world scenarios with heavy oversight. Kev Coleman, a fellow at the Trump-aligned Paragon Health Institute, suggested such an approach last year. The strategy could allow developers to demonstrate their products' utility, he told Ruth at the time, while also giving policymakers insight that could help shape future policy. Outside the government: AI Centers of Excellence around the country will enable 'researchers, startups, and established enterprises' to test AI tools with the understanding that they will have to publicly share the data and results of their experiments. The Food and Drug Administration will oversee testing of tools related to health care with support from the National Institute of Standards and Technology. The action plan also charges NIST with convening a broad range of health care industry stakeholders — academics, company executives, nonprofits, and industry groups — to develop national standards for AI systems, including measurements for understanding how much AI increases productivity. It calls on both NIST, the National Science Foundation, and federal agencies to develop methods for evaluating the performance and reliability of AI systems using regulatory sandboxes. Inside the agencies: The action plan establishes a Chief Artificial Intelligence Officer Council to coordinate interagency collaboration on AI. This group would work with the White House's Office of Personnel Management to create a talent exchange program that would allow federal employees to be quickly detailed to other agencies in need of expertise. It would also develop an AI procurement toolbox, managed by the General Services Administration in coordination with the White House Office of Management and Budget, that would allow any federal agency to adopt a model already in use within the federal government and customize it for its own purposes. The new council is also supposed to set up a technology and capability transfer program, such that agencies can more easily share knowledge and tools. Finally, the plan requires agencies to ensure employees who could benefit from AI tools have access to them. And it asks that agencies facilitate uses of AI that could improve delivery of services to the public. The big picture: Health systems want to be sure AI tools are safe before deploying them but there is no established framework for doing that. Several industry groups are trying to get consensus on the issue. Trump has largely pursued a deregulatory approach to advancing AI, but his new plan acknowledges the industry's desire for guardrails. WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. According to Science, researchers developing a new type of dental floss to protect against the flu ran into a challenge while testing their needleless vaccine: trying to floss a mouse. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: CarmenP.82, RuthReader.02 or ErinSchumaker.01. AROUND THE AGENCIES The National Institutes of Health is capping the number of grant applications researchers can submit each year. The agency posted a notice last week about the new restrictions, which limit principal investigators to six new, renewal, resubmission or revision applications each calendar year. The stated reason behind the change: the risk of researchers overwhelming reviewers with artificial intelligence-generated applications. The NIH said it had identified instances of principal investigators who submitted large numbers of applications that might have leaned heavily on AI. In one instance, an investigator submitted more than 40 different applications in one submission round. 'While AI may be a helpful tool in reducing the burden of preparing applications, the rapid submission of large numbers of research applications from a single Principal Investigator may unfairly strain NIH's application review processes,' the notice says. Since NIH policy requires that grant applications be the original work of the applicants, the agency won't consider applications 'substantially developed' by AI or with sections that are AI-generated. Reality check: The percentage of investigators submitting an average of more than six applications has been low, according to NIH. Carrie Wolinetz, a lobbyist at Lewis-Burke Associates and former senior adviser to NIH director Francis Collins, told Erin that she thinks the impact of the cap will vary by institution. 'I don't think it's a bad idea as a matter of policy. If funding is robust, it could increase the quality of applications,' Wolinetz said. 'I am a little skeptical that limiting applications somehow disincentivizes the use of AI,' she said, adding, 'Although I also don't think limiting the use of AI for application writing is a bad idea.' Do as I say: The White House acknowledged in May that a Make America Healthy Again report spearheaded by HHS Secretary Robert F. Kennedy Jr. contained 'formatting issues' and pledged to correct them. The acknowledgment came after the news outlet NOTUS reported that the MAHA report cited sources that didn't exist, a hallmark of AI use. What's next: The policy goes into effect on Sept. 25.
NBC News
13 hours ago
- Health
- NBC News
Summer Covid cases are rising across the U.S. — Is it time for a vaccine?
As Covid cases begin to rise this summer, many may be wondering: What are my risks, and is it time to get another vaccine? As of July 15, Covid cases were growing or likely growing in 27 states including Texas, Illinois, Kentucky, Virginia and Ohio, according to the Centers for Disease Control and Prevention. Rates of positive Covid tests have also been increasing in recent weeks, the CDC says, specifically in the southern region of the country. N.B.1.8.1 is the current dominant variant in the United States, accounting for 43% of all new Covid cases, according to the CDC. It's an offshoot of the XVD.1.5.1 strain, a descendant of the omicron variant. N.B.1.8.1 was responsible for a surge in hospitalizations in China earlier this year. It's been nicknamed 'razor blade throat,' as there have been anecdotal reports of some people getting painful sore throats, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee. Schaffner noted, however, that sore throats have been a common symptom of Covid since it first began spreading. 'I doubt the clinical spectrum of Covid has changed substantially,' Schaffner said. Do I need a Covid booster? When will the new vaccines be available? The uptick in cases comes as many Americans have likely gone a year or longer without a Covid shot. In May, the Food and Drug Administration asked drugmakers to update their Covid vaccines to target the LP.8.1 strain, a descendent of JN.1, which began spreading widely in 2023 and is another offshoot of omicron. LP.8.1 currently accounts for 31% of all new cases, per the CDC. The new shots won't be available until the fall, and are expected to be approved only for adults 65 and up and kids and adults with at least one medical condition that puts them at risk of severe illness. Healthy kids and adults who want a shot may have to find an older version or pay out of pocket. A single dose can cost as much as $140. Experts say, however, that population immunity — whether from vaccination, prior infection or both — may shield much of the public for now. 'While we don't have a lot of high level of immunity in the population right now, because it's been so long, we may have enough low level immunity to just make it a little bit harder for that virus to transmit easily from person to person,' said Andy Pekosz, an infectious disease researcher at Johns Hopkins University. Indeed, weekly hospitalization rates have remained low, suggesting that the new variant may not be leading to severe illness. The number of cases are still drastically lower than those this time last year, when the test positivity rate peaked in August at 17.9%. The 2025 season has yet to scrape 5%. Pekosz said it isn't unusual for cases to rise during the summer time, when people are likely to crowd indoors to escape the heat. However, he believes that if there is a summer surge of cases, it will be a small one. 'The variants have been around for a while and haven't caused any major surges up until date,' Pekosz said. 'So again, I'm hopeful that if we see a surge, it'll be a low level surge compared to previous years.' Dr. Ofer Levy, director of the precision vaccines program at Boston Children's Hospital, who has advised the FDA, said people who are at high risk of severe illness still may want to consider getting a Covid shot, if they can find one. High risk groups include: Older adults People with weakened immune systems Pregnant women Those with underlying health conditions, such as asthma and heart disease Getting a shot is especially important, Levy said, for those who haven't had one in over a year and whose immunity has likely waned. 'If you're in a high risk group and you're in a state where cases are rising, you may want to just get the first available appointment and get a shot to protect yourself,' he said. People at high risk can then consider getting an additional Covid shot when the updated vaccines are distributed in the fall, he said. Covid has two waves a year Schaffner, of Vanderbilt, said people in the high risk groups may also want to consider wearing a mask during indoor activities, such as the movies. Healthy adults and children may be able to wait longer before getting another shot, Levy added. 'If you're in a lower risk group, that's where things get fuzzy,' he said. 'I mean if you want a vaccine and your health care provider concurs and you can get it.' Dr. Michael Phillips, an infectious disease doctor at NYU Langone, said that he sees mostly immunocompromised and older adults test positive for the virus. For those who haven't gotten a Covid shot in years, Phillips said he doesn't think they should worry just yet. 'If you're younger, otherwise healthy, I think you're OK,' Phillips said. 'If you have underlying pulmonary disease, you know, if you're an older age group, now that's a time when you should be really talking to a doctor and saying, 'Gosh, should I be getting a booster for Covid?'' He said that the amount of positive Covid tests NYU Langone has seen has decreased 40% since February. Fatima Amaeka, a senior analyst at the Center for Outbreak Response Innovation at Johns Hopkins, said she expects the current wave to peak around September. Schaffner said to expect another wave in the late fall and winter. '[Covid] has two increases each year,' he said. 'Everyone is familiar with the winter increase that goes along with flu and RSV.'
IOL News
13 hours ago
- Health
- IOL News
Why the world must aim to eliminate PEPFAR and end the HIV epidemic
Last week, the President's Emergency Plan for AIDS Relief narrowly escaped a devastating $400 million budget cut thanks to Republican Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska), who voted alongside their Democratic colleagues to protect the program. That was a relief: Since its creation under President George W. Bush in 2003, the anti-HIV/AIDS program has saved an estimated 26 million lives and allowed 7.8 million babies to be born HIV-free. But preserving PEPFAR shouldn't be seen as the end goal. Instead, global health officials should be working toward the day when the world no longer needs it. That ambitious goal might sound far-fetched, given that an estimated 1.3 million people were newly infected with HIV in 2023 globally. But consider this: Last month, the Food and Drug Administration approved a drug called lenacapavir, a twice-yearly injectable treatment that clinical trials have shown is 100 percent effective at preventing HIV infection among young women and 96 percent effective among gay and bisexual men and transgender people. The drug has the potential to be a groundbreaking improvement over the current standard for HIV prevention, oral PrEP (pre-exposure prophylaxis treatment). For all its promise, oral PrEP has confronted the difficult realities of human behaviour. Adhering to a daily medication regimen is challenging under any circumstances, but especially so in communities where HIV-related stigma is pervasive. Even in wealthier countries, gay men who take the medication have been disparaged. Oral PrEP also tends to be less effective in women, though studies differ on whether this is due to lower adherence and access barriers or biological differences in how the medication is absorbed in female anatomy. Lenacapavir, manufactured by Gilead Sciences, could help address these challenges. It is discreet and can be administered privately in a clinical setting. It requires dosing only twice a year, and it is easier and less painful to administer than previous injectable drugs to prevent HIV. In the United States, lenacapavir costs more than $28,000 per person per year before insurance. But Gilead has licensed six generic manufacturers to produce the drug at cost for 120 low- and middle-income countries. Together with the Global Fund, the company has pledged to distribute 2 million doses - still a drop in the bucket compared to what's needed for population-level protection, but a meaningful start. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Ad loading Of course, the drug is no silver bullet. Unfortunately none of the licensed generic manufacturers are based in sub-Saharan Africa, the region with the greatest need, and scaling up production could take years. So far, the U.S. is the only country to approve it, and regulatory timelines elsewhere are likely to lag. Nevertheless, lenacapavir is exciting for what it represents: An innovation that can draw PEPFAR into a new era defined not by fighting HIV, but ending it. Advocates of the program should remember that it was designed as an emergency response to an uncontained pandemic; for it to become a permanent fixture of global health would constitute a failure of its mission. Moreover, the program is far from perfect. Like many HIV prevention programs, it often sacrifices preventative care for treatment when budgets tighten. Those trade-offs stand in the way of HIV elimination. The program is also, regrettably, subject to the whims of U.S. politics. In February, Secretary of State Marco Rubio restricted HIV prevention aid so that only pregnant and breastfeeding women can receive it - as if to invite more AIDS epidemics. The world has a long way to go until PEPFAR can safely be shuttered. After all, foundations and private companies cannot replace the program, which provides nearly 70 percent of global financing for HIV/AIDS response. But it's possible to imagine a future in which biomedical science and investments into a sustainable health infrastructure make the program obsolete. That's something the world should strive for. - The Washington Post
