Latest news with #AaronKesselheim
Yahoo
a day ago
- Health
- Yahoo
Trump officials ‘secretly' changed US health data in ‘gender ideology' crackdown, researchers allege
The Trump administration quietly altered massive US health datasets to remove any mention of gender, according to a new analysis. Scientists around the world rely on health data from US government agencies like the Centers for Disease Control and Prevention (CDC). But since President Donald Trump took office in January, these agencies have been altering data labels, mostly without disclosure, according to the investigation published in The Lancet, a leading medical journal. The authors argue that the 'hidden' changes could cast doubt on the integrity of American science. The database edits 'might be politically motivated and [are] not transparent,' Dr Aaron Kesselheim, a professor at Harvard Medical School, and Janet Freilich, a law professor at Boston University, said in the paper. Related Will Trump's funding cuts help Europe lure top research talent from the US? Their analysis included 232 US health datasets that were edited from late January to late March, covering veterans' health care use, global tobacco consumption, stroke deaths, nutrition, exercise, and obesity. It did not include datasets that are updated on a regular basis. About half of these datasets were 'substantially altered' during the two-month period, but only 15 acknowledged that changes had been made, the study found. The parts of the datasets meant for these disclosures remained empty as of early May, the researchers said. In most of the edited datasets – 106 of them – the word 'gender' was swapped out for 'sex'. Related US demands that EU companies comply with anti-diversity order US agencies have not confirmed or explained the changes, but Freilich and Kesselheim suspect they were made to comply with a Trump order to remove 'messages that promote or otherwise inculcate gender ideology'. The executive order, issued on Trump's first day in office, said it aimed to restore 'biological truth' to US agencies, and set a national policy 'to recognise two sexes, male and female,' they said. It was part of a flurry of activity to clamp down on LGBTQ protections. Some data was initially removed from federal websites, but was largely restored due to a court order. Related Trump administration's funding freeze for foreign medical research to hit European scientists The Lancet analysis indicates that not all changes were reversed. It is not clear if the actual numbers were altered, or only the labels about gender or sex. But Freilich and Kesselheim said the distinction is important because some people will respond to surveys differently based on each term. That can undermine the quality of the data and lead researchers to draw inaccurate conclusions, they said. They described the undisclosed changes as a 'crisis' that could make US data 'untrustworthy and unusable'. They called on governments elsewhere in the world to invest in other data sources.
Yahoo
13-03-2025
- Health
- Yahoo
Nearly a third of FDA medical device adverse event reports filed late
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration's (FDA) required 30-day window across a three-year period, a new cross-sectional study has found. Published in the BMJ, the study analysed more than four million reports submitted to the FDA's centralised Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 and December 2022. The agency relies on such disclosures to inform decision-making over whether to communicate safety concerns or pursue other regulatory actions. The study researchers found that 4.5% of AEs were reported between 31 and 180 days and 9.1% after 180 days later than the FDA's required window while 15.5% of reports had missing or invalid data provided by the manufacturer. In addition, 71% of AEs throughout the assessed period were reported within the required window. Late AE reports were determined to be concentrated among a few manufacturers, with three manufacturers contributing towards 54.8% of late reports, with a mean late reporting rate at the manufacturer level of 23.4%. The top manufacturers with the highest level of late reports included Becton Dickinson, Medtronic, Abbott, and Boston Scientific. Similarly, 13 devices attributed to 50.4% of late reports. Researchers found that the top ten devices ranked by total late reports included Becton Dickinson's infusion pumps, Abbott's glucose monitors, and Medtronic's insulin pumps. Out of all reports filed to the MAUDE database across the period, 13,587 were deaths, around 1.5 million were injuries, and almost three million malfunctions, with the figures originating from 3,028 unique manufacturers and 88,448 unique medical devices. However, it was out of the scope of the study to determine the impact that the percentage of reports filed late may have had on onward action taken by the FDA. In an editorial accompanying the BMJ publication, Harvard Medical School-affiliated researchers W B Feldman and Aaron Kesselheim said that such delays and information gaps can 'hinder regulatory action, undermine trust in the MAUDE system, and harm patients' if problems with sensitive diagnostic equipment or life-saving treatments are not swiftly addressed. The research group stated that while an effective tool, MAUDE has known limitations, including a reliance on external individuals and organisations to report AEs, rather than systematically and prospectively collecting safety and outcome data. To bolster its ability to improve corrective actions being taken over certain medical device recalls, the FDA's Center for Devices and Radiological Health (CDRH) initiated a pilot last year that centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls. The FDA recently issued an early alert over a 'potentially high-risk' issue with certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps and tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as Class I. "Nearly a third of FDA medical device adverse event reports filed late" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
