480,000 Americans die from smoking each year according to FDA commissioner Scott Gottlieb. Well it’s time to take another big swing at preventing those deaths, at least that’s what’s behind the FDA’s new move to cut nicotine levels down in cigarettes. In the US, cigarettes are typically made with a nicotine dose of around 1.1-1.7 milligrams. The regulatory agency wants to cut that to a maximum of 0.4 milligrams, which could help 5 million Americans quit smoking within a year. The move is focused on combustible cigarettes which probably give you the most bang for your buck in terms of ways they can kill you, as opposed to newer vaping products which have pretty high nicotine levels themselves. Presumably, the FDA doesn’t want to impinge on the very cool emerging field of vape tricks.
For those interested in solving ALS (aka Lou Gehrig’s disease), last week was pretty good. While fewer than 20,000 people each year in the US are diagnosed with ALS, the impact of the disease is devastating. Researchers from Syracuse University, St. Jude’s, and SUNY Update Medical Center published a paper in Molecular Cell describing how ubiquitin eliminates droplets of Ubiquilin-2 (UBQLN2) in solution. This is important because UBQLN2 is found in motor neuron inclusions of ALS patients. The hope is that the research can lead to a better understanding of ALS’ molecular mechanisms. In a separate study, NIH-funded researchers at Stanford “used the gene editing tool CRISPR to rapidly identify genes in the human genome that might modify the severity of amyotrophic lateral sclerosis (ALS) caused by mutations in a gene called C9orf72.” Go get ’em. We couldn’t say it any better: #ALSsucks
Theranos founder Elizabeth Holmes has settled the “massive fraud” charges levied against her by the SEC. A little refresher, Theranos was that company that was going to revolutionize the world of laboratory blood testing and then didn’t deliver. That sent Forbes’ evaluation of her to plummet from ~$4.5B to ~$0.0B, and brought a lot of scrutiny from federal agencies, which eventually culminated in this deal. As part of the stipulations, Holmes can no longer run Theranos, nor be an officer or director of a public company for 10 years.
Shout out to fellow massive fraud Martin Shkreli who was sentenced to 7 years in prison last week. We didn’t feel like giving the jerk a full story, but you’ll be happy to know he cried at his sentencing.
Last week proposed legislation dubbed the “right-to-try” bill failed to pass the US House of Representatives, despite a lopsided 259-140 vote in favor of the law. Republicans who submitted the bill used a process that required a two-thirds majority to pass and the numbers fell just short of that. The new submission will require on a simple majority to pass—and it will. Here’s Austin Powers in a nutshell. More importantly, here’s the law in a nutshell… critically ill patients can gain access to experimental drugs if their physician and the drug company agree to it. The FDA would no longer need to sign off. Supporters say the law removes red tape. Critics say the FDA already approves 99% of requests and, according to Scott Gottlieb, FDA Commish, requests are usually approved immediately or within a few days anyway. So, where’s the beef?
Yes, that’s a TSwift “Mean” reference. Not saying we’re proud of it and not saying we’re not. Speaking of mean, FDA Commissioner Scott Gottlieb was mean this week. Using phrases like “rigged payment scheme” and “team up with payors” and “insidious barrier” Gottlieb took aim at PBMs, distributors, drug stores and pharmaceutical companies talking about how these entities “effectively split monopoly rents” instead of passing on savings to consumers. These comments came during a speech where he pointed out that 9 biosimilars have been approved by the FDA and only 3 are for sale. (see InsightCity’s Biosimilar HealthyDose) You’ll be shocked to know that the insurance companies blame the pharma companies and the PBMs blamed the insurance companies. Perfect. BTW, Europe has seen drug prices fall as much as 60% with the introduction of biosimilars. Not too shabby.