Read today’s Kaiser Health News
In other news:
NIH grant funding losses, by state FYI
About pharma
How we plan to cut FDA drug approval time by months [From the FDA commissioner]:The program will make use of the idle time during clinical trials — time needed to see how the drug in question performs. Instead of submitting all the data at the end of a trial, qualifying manufacturers will be able to submit most elements of the application — including manufacturing details and drug labeling — while the trial is underway. The FDA will be able to review the early data and resolve any issues with the manufacturer at that time. Once the trial concludes, final data will be submitted. Then there will be about one month of FDA review, followed by a focused, one-day meeting with FDA scientists to reach a decision. This split-submission approach is entirely feasible — as shown by its success during Operation Warp Speed at the start of the covid-19 pandemic.
Comment: Great news and makes sense. But how will the FDA review data if it fires seasoned staff? See the article below.
FDA gene therapy leaders sidelined amid broader agency overhaul: The FDA has placed Nicole Verdun, director of the Office of Therapeutic Products (OTP), and her deputy Rachel Anatol on administrative leave, removing two senior officials that industry leaders said have steered efforts to modernise the agency's approach to cell and gene therapy regulation over the past two years.
The personnel moves represent the latest in a series of changes across the Department of Health and Human Services (HHS) since the Trump administration took office in January. The FDA specifically has experienced significant turnover among senior staff, including the ousting of long-time Center for Biologics Evaluation and Research (CBER) director Peter Marks in March. He has since been succeeded by Vinay Prasad.
NICE reaffirms negative stance on Alzheimer's therapies Kisunla, Leqembi: The UK's National Institute for Health and Care Excellence (NICE) has again ruled that the benefits offered by two recently approved amyloid plaque-targeting therapies for Alzheimer's disease are too small to justify their additional cost to the NHS.
About the public’s health
Weight Trajectory Impacts Risk for Ten Distinct Cardiometabolic Diseases: Results: Compared to weight stability, weight cycling associated with almost 30% increased risk for obstructive sleep apnea (HR 1.28; 95% CI 1.15-1.42), MASLD (HR 1.28; 95% CI 1.08-1.51), and T2DM (HR 1.23; 95% CI 1.10-1.38). Weight cycling also associated with more than 50% increased risk for heart failure (HR 1.54; 95% CI 1.31-1.82), although both weight gain and weight loss also showed increased risk for HF (HR 1.29; 95% CI 1.08-1.55 and HR 1.32; 95% CI 1.10-1.58, respectively).
Conclusions: The relationship between weight cycling and cardiometabolic disease risk was independent of having high baseline BMI, which was similar among weight trajectory groups. The present findings support promoting either weight stability at high BMI or weight loss if able to be maintained to prevent the incidence of a variety of cardiometabolic diseases.
About healthcare IT
Billions of login credentials have been leaked online, Cybernews researchers say: Researchers at cybersecurity outlet Cybernews say that billions of login credentials have been leaked and compiled into datasets online, giving criminals “unprecedented access” to accounts consumers use each day.
According to a report published this week, Cybernews researchers have recently discovered 30 exposed datasets that each contain a vast amount of login information — amounting to a total of 16 billion compromised credentials. That includes user passwords for a range of popular platforms including Google, Facebook and Apple.
Sixteen billion is roughly double the amount of people on Earth today, signaling that impacted consumers may have had credentials for more than one account leaked.
Health systems caught in data breach affecting 5.4 million individuals: Episource, which provides medical coding and risk adjustment services to health systems and payers, said it turned off its computer systems Feb. 6 after detecting unusual activity on its network. The firm later determined that a cybercriminal accessed and stole data between Jan. 27 and Feb. 6.
The data may have included names, dates of birth, Social Security numbers, diagnoses, medications and treatment information. Episource said it has no evidence any of the data has been misused.
About healthcare personnel