Fraudulent clinical drug trials; HHS, RFK Jr. direct FDA to end industry self-affirmation of food ingredient safety; blood test for early dementia detection in sleep disorder patients – Morning Medical Update

Florida medical clinic owners plead guilty in clinical trial fraud case

The owners of A&R Research Group, a Florida-based clinical trial facility, pleaded guilty to conspiracy to commit wire fraud for falsifying data in asthma drug trials. Angelo Baquero and Ricardo Acuna admitted to fabricating patient records and test results to fraudulently secure payments from drug sponsors. Additionally, Matthew Teltser, MD, FACC, the clinical investigator, pleaded guilty to making false statements to a Food and Drug Administration (FDA) investigator. All three face sentencing later this year, with each defendant facing up to five years in prison.

HHS, RFK Jr., directs FDA to end industry self-affirmation of food ingredient safety

Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has directed the FDA to explore eliminating the self-affirmed GRAS (Generally Recognized as Safe) pathway, which allows companies to deem food ingredients safe without notifying the agency. The move aims to increase transparency and oversight of food additives. Currently, manufacturers can voluntarily submit safety data, but reporting is not required. The FDA will assess rulemaking options, while HHS considers legislative action to close the loophole.

Blood test shows promise for early dementia detection in sleep disorder patients

Researchers at McGill University have found that a blood test, originally designed for Alzheimer’s disease, may help predict dementia years before symptoms appear in people with idiopathic REM sleep behavior disorder (iRBD). The study, published in Brain, showed that biomarkers in the blood could identify nearly 90% of iRBD patients who later developed Dementia with Lewy Bodies. The study suggests a potential overlap between Alzheimer’s and Parkinson’s-related dementias, opening the door for early intervention and treatment trials.