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Showing posts with the label ethics

Drug company shenanigans: this one remarkably unethical

  A recent study documented a significant ethical violation by drug companies, finding that for low income countries that were involved in drug testing studies, the successful drugs were not   subsequently  available to the participants (see   clinical trials countries involved not get meds later JAMAIntMed2025  in dropbox, or doi:10.1001/jamainternmed.2025.6060)   Details: -- they identified all novel drugs and biologics approved by the FDA from 2015 through 2018, along with their approved indication, as well as all phase 2 and 3 clinical trials supporting their FDA approval from 2015 to 2018, with data from the Drugs@FDA database, ClinicalTrials.gov website, and drug regulatory agency websites, in this retrospective analysis -- countries were categorized into 4 income groups (high, upper middle, lower middle, and low) using the World Bank's historical classification of economies, and by the geographic regions using the United Nations regional groupings of...

23andMe genetic analysis approved for direct advertising

The FDA just approved direct-to-consumer marketing for genetic risk information (23andMe Personal Genome Service Genetic Health Risk) for 10 conditions, though noting that "the tests cannot determine a person's overall risk of developing a disease or condition ... there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors." This approved test involves saliva samples, assessing more than 500,000 genetic variants associated with increased risk of: Parkinson's disease, late-onset Alzhemer's , Celiac disease, Alpha-1 antitrypsin deficiency, Early-onset primary dystonia, Factor XI deficiency,  Gaucher  disease type 1, Glucose-6-phosphate dehydrogenase deficiency, Hereditary hemochromatosis, Hereditary thrombophilia. see  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm ​  The FDA reviewed the data for 23andMe through a premarket review pathway for low-to-moderate risk...