Drug shortages are nothing new, that’s why the FDA updates their list of shortages daily. But things seem a little worse than normal—9 in 10 physicians say their emergency departments lack critical medicines. That includes mainstays like diltiazem (a go-to treatment for hypertension) and morphine. You can blame market forces and manufacturing issues. Most of the drugs in shortage are sterile injectables, which can be difficult to both make and make a profit on. Those low margins can lead to less incentive to maintain the quality of sterile injectable manufacturing facilities as they age, which in turn leads to issues with the quality of the drug products. It’s things like that which can cause cardboard to contaminate batches of “sterile” injectables. If only they had contaminated them with cash instead…
We didn’t make that up, the ASPB is an actual thing. Before you start in with your favorite Little Shop of Horrors plant references, you might want to wait. Some background: montbretin A (MbA), a natural compound with the potential to treat type-2 diabetes, was discovered in the ornamental plant montbretia 10 years ago, but it couldn’t be produced on a large scale until its biosynthesis was understood. Scientists have now discovered genes and enzymes responsible for MbA biosynthesis and demonstrated the potential for metabolic engineering of wild tobacco to produce this promising drug candidate. Seeing that the 2016 global diabetes drugs market was valued at ~$31 billion and is estimated to reach USD ~$45 billion by 2021, the question is, who will license the technology? Our guess, Novo Nordisk.
In a move that InsightCity writers believe will become more popular in the coming years, Medtronic announced it’s putting its money where its mouth is for their MiniMed 670G insulin pump system (not for the popular BBC antiques television show). Already well established for the treatment of type 1 diabetes, Medtronic is looking to take a larger part of the larger type 2 market. According to the announcement, “with this guarantee, Medtronic will provide flat-fee reimbursements up to $25,000 per pump over 4 years for qualifying diabetes-related inpatient hospitalization and emergency room admissions for eligible in-network patients in the United States.” These outcomes-based pricing models have been in play for a bit and they are evolving. Italy has used them with limited success since 2016, according to this Wall Street Journal article. We’re just sayin’, we hope it works.
Here at InsightCity we’ve tossed around the idea of including a semi-regular section called Coffee, Alcohol or Chocolate. It essentially would just cover whatever substance of those three is the latest to blame for cancer, early death, superpowers, etc. Well, we’re calling for a moratorium on the coffee studies at least, because we want this one to be the last one. A study of half a million UK citizens has found that drinking coffee is good for you, hands-down. The study looked at a wide range of coffee factors like amount consumed, sub-types (e.g. decaf, instant,) and participants’ caffeine metabolisms. Essentially, even if you’re drinking 8+ cups of coffee a day, you’re still getting the health benefits of the world’s favorite bean soup in the form of decreased mortality. Cheers.
When was the last time you swam in a public place (pool, beach, etc.)?
The first drug derived from marijuana has been approved for sale in the US. Under the brand name Epidiolex, the purified cannabidiol (CBD) substance has shown promise as a treatment for two rare forms of epilepsy. CBD is the compound in marijuana that researchers have identified as what gives the “Devil’s lettuce” its medicinal properties. This shouldn’t be confused with THC which is what gives Cheech & Chong (Warning: language and, obviously, drug use) material for their comedic properties. CBD oil has been touted as a treatment for severe epilepsy in the past few years but having an FDA-approved drug with consistent quality and dosage could give physicians more confidence in prescribing it. The approval also influences enforcement, forcing the US Drug Enforcement Agency to reschedule the drug since it now has an accepted medical use.
For those InsightCity readers who live in the clinical development space, this will be interesting. For everyone else, sorry. The biggest barrier to on-time completion of clinical trials is patient recruitment. Getting enough patients to enroll in and then stay with a trial is quite difficult. PPD, a top-5 private CRO, is thinking outside the box. Typically, in a clinical study, the pharma company or CRO will recruit clinical sites (think doctor’s offices/ hospitals) to participate and then try to recruitment patients. Well, PPD has flipped the script and is trying to find the patients first, then show them where they can go to participate in the trial. PPD’s PatientAdvantage program has shown some impressive improvements against industry norms for recruitment timelines and you know it’s big when Drake weighs in on recruitment (albeit basketball). Sorry Rick Pitino.