When Purdue Pharma's patent on the MS Contin was close to expiry, the Sackler family who owned the company spent millions trying to find a product that could replace the profits they'd lose from generic competition on MS Contin: the result was Oxycontin, a drug that went on to kill Americans at epidemic scale. Read the rest
The Electronic Frontier Foundation just filed comments with the FDA in its embedded device cybersecurity docket, warning the agency that manufacturers have abused the Digital Millennium Copyright Act, threatening security researchers with lawsuits if they came forward with embarrassing news about defects in the manufacturers' products. Read the rest
Both the UK and Australian governments have issued reports describing homeopathy as bunk, and now the US Food and Drug Administration and Federal Trade Commission are holding hearings on the regulation of high-priced sugar-pills. Read the rest
Back in September, the Centers for Disease Control and Prevention issued a report connecting the use of antibiotics in livestock to antibiotic resistance in humans. It was an important step in turning science into action. Although human use and misuse of antibiotics and the spread of antibiotic-resistant bacteria in hospitals are important parts of the puzzle of antibiotic resistance, the massive use of antibiotics by the agricultural industry also plays a key role. In fact, the vast majority of antibiotics used in the United States are used by animals. (Reasonable estimates range as high as 80%.)
What's more, the vast majority of that antibiotic use has nothing to do with the health of the animals. The antibiotics have the side effect of promoting weight gain. Important drugs like penicillin and tetracycline are regularly doled out to cows and pigs and chickens as part of their daily feed in order to make them fatter — a practice which has been shown to directly reduce those drugs' effectiveness at treating actual illness in humans. Today, the FDA announced that it plans to change this ... but there are problems. Read the rest
At what point does interesting-but-potentially-incorrect-or-misleading information become a potential threat to health? How do you regulate a product that current regulations were never set up to handle? The University of Michigan's Risk Science Center put together this quick cartoon that neatly summarizes the problems and questions at the heart of the FDA's crackdown on 23andMe, which Xeni wrote about on Monday.
A couple of other smart takes on this that have come out in the past couple of days: • Genomics expert Michael Eisen delves deeper into the question of how we should regulate personal genetic testing. • Journalist David Dobbs rounded up some diverse opinions. You should pay attention to his blog. He's been doing a lot of great reporting on genetics and culture and is planning on publishing a longer piece on the 23andMe stuff later this week. Read the rest