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CNN
an hour ago
- CNN
U.S. House takes up Trump Agenda bill
The House takes up the revised Senate version of President Trump's sweeping domestic agenda bill, which passed the Senate on Tuesday by the slimmest of margins. CNN Political Analyst and Historian Leah Wright Rigueur says if the bill becomes law, people will remember Donald Trump as the President who increased the national debt and took away people's healthcare.
Associated Press
an hour ago
- Associated Press
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
WASHINGTON (AP) — The government's top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday. The new memos from the Food and Drug Administration show how the agency's vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna. Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers. But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare. Instead Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues. Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It's the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines. 'Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits' Prasad wrote in a five-page memo explaining his decision. COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months. Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad can overrule staffers, but such cases are rare and often controversial. News of the FDA documents was first reported by the New York Times. Prasad was hired to lead the FDA's vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy. An academic researcher specializing in cancer therapies, Prasad came to prominence during the pandemic for criticizing public health measures, including the FDA's approval of COVID boosters for healthy adults and children. Since arriving at the agency he has worked with FDA Commissioner Mark Makary on new guidelines that will limit approvals of future COVID boosters to higher-risk Americans, mainly seniors and those with medical conditions like asthma and obesity. Those limits match the terms FDA recently approved for Novavax's shot, Nuvaxovid and Moderna's mNexspike. Novavax's vaccine is the only protein-based coronavirus vaccine available in the U.S. Moderna's vaccine is an updated, lower-dose version of its existing mRNA-based vaccine. The review team for the Novavax vaccine pointed to data from a study in 30,000 adults, concluding that 'the risk-benefit assessment for this vaccine technology remains favorable.' FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company's original shot. Last week, the FDA finalized new warning labeling about the risk of myocarditis, a rare form of heart inflammation, on shots from Moderna and Pfizer, the other maker of an mRNA-based shot for COVID. In his 'override memo,' reversing FDA staff's decision on the Moderna shot, Prasad pointed to the ongoing risk of myocarditis and questions about its frequency. The agency ordered Moderna to conduct further studies of the risk as a condition for the approving its updated shot. A spokesman for the administration said Prasad 'has raised serious concerns' about the issue. 'We will not ignore these risks and will ensure that the gold standard of science is used for any decisions,' said Andrew Nixon, in an emailed statement. Outside researchers have noted that cases of the heart condition tend to resolve quickly and are less severe than those associated with COVID infection itself, which can also cause myocarditis. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Medscape
an hour ago
- Medscape
Fast Five Quiz: Transthyretin Amyloid Cardiomyopathy Management
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a type of systemic amyloidosis that causes restrictive cardiomyopathy and can affect the peripheral and autonomic nervous systems. After diagnosis, patients should be referred to consultation with cardiologists as well as other specialists to develop a treatment plan based on their symptoms. Because this condition can affect several different organ systems, disease management requires a multidisciplinary approach. Are you up to date on your understanding of ATTR-CM management ? Test your knowledge with this quick quiz. ATTRwt, the more common type of ATTR-CM, usually occurs as a function of age, whereas hATTR usually occurs as a result of TTR mutations. Several siRNA agents and ASOs are available to treat polyneuropathy associated with either type. Liver transplantation, which removes mutant TTR from the blood, has been used to treat hATTR, but the development of newer medications has reduced the need for transplant. Patients with ATTR-CM should be treated with interventions that address all their symptoms, including heart failure, arrhythmias, conduction system disorders, and extracardiac manifestations. Learn more about treatment considerations for hATTR and ATTR-CM. Volume management is an essential element of cardiac amyloidosis treatment, especially if heart failure symptoms are present. In patients with ATTR-CM and heart failure symptoms, loop diuretics are used to maintain euvolemia. Because diuretics can reduce preload, blood pressure should be carefully monitored to prevent adverse effects on renal perfusion and cardiac output. Renin-angiotensin system inhibitors can exert vasodilative effects and have been shown to cause hypertension in this setting. Beta-adrenoceptor blockers have been shown to exert negative chronotropic effects and can worsen symptoms of heart failure Cardiac glycosides, such as digoxin, are usually not recommended in patients with ATTR-CM. Learn more about treating cardiac involvement in ATTR-CM. Transthyretin stabilizers, including tafamidis, vutrisiran, and acoramidis, are approved to treat cardiomyopathy in both hATTR and ATTR-CM in adults. They work to reduce cardiovascular mortality and cardiovascular-related hospitalization. However, they have not been shown to reverse existing damage. Clinical trials have demonstrated that this medication class significantly reduced all-cause mortality and lowered hospitalization rates in addition to slowing disease progression. This medication class was also generally well tolerated in most patients with minor side effects, including urinary tract infection. Clinical data also showed that starting this medication class earlier in the disease course might provide improved long-term outcomes. Learn more about transthyretin stabilizers for ATTR-CM. OH is defined as a reduction of ≥ 20 mm Hg in systolic blood pressure or 10 mm Hg in diastolic blood pressure within 3 minutes of standing or upright tilt; further, it is a common complication of ATTR-CM. Nonpharmacologic management of OH can include compression stockings (which can produce ≥ 15-20 mm Hg of pressure) and elastic abdominal binders. Reduced fluid intake has been shown to worsen OH but specifics regarding intake amount in the setting of ATTR-CM can be individualized according to the patient. Though magnesium supplementation has been shown to help manage blood pressure in certain cases, there is limited evidence regarding its role in the treatment of OH associated with ATTR-CM. Evidence regarding vitamin D supplementation in this setting is also limited. Learn more about managing different conditions associated with ATTR-CM. siRNAs and ASOs, considered to be TTR ' silencers,'work in similar ways to 'knock down' the production of TTR in the liver. Their mechanism of action involves targeting TTR mRNA for degradation. This prevents it from being translated, reducing the amount of TTR protein in circulation and disables retinol (vitamin A) transport. TTR stabilizers bind thyroxine 4 into one of two transthoracic echocardiography interdimeric binding pockets. This prevents dissociation into amyloidogenic TTR monomers and oligomers, thereby increasing the stability of the tetramer. Learn more about how different medications treat ATTR-CM. Editor's Note: This article was created using several editorial tools, including generative AI models, as part of the process. Human review and editing of this content were performed prior to publication.
