Leaving an unencrypted laptop containing more than 2,230 patient records in an unlocked vehicle overnight might be a bad idea. Even more so when it turns up stolen and your company is facing its third major security breach in a single year. According to the U.S. Department of Health and Human Services (HHS), “Demographic information, clinical information, health insurance information, patient names, addresses, credit card numbers and their expiration dates, and dates of birth” are some of the data stolen during three incidents for Advocate Health Care Network in 2013. Those mishaps have resulted in a $5.5 million settlement with the HHS, the largest data breach settlement ever. Advocate, however, reports that there have been no indications that the information has been misused… Yet. Yay?
Even though it seems like a reasonable explanation when you consider the 450,000 condoms being distributed within the Olympic village, instead, the splotches are the after-effect of the newest Olympic fad: cupping (yes we know, it even sounds gross). However the process itself is not a fad, it’s been done for at least 2,000 years along with other forms of traditional Chinese medicine like acupuncture. Similar to other forms of TCM, cupping doesn’t have a lot of rigorous clinical data to support it yet. The randomized clinical trials investigating cupping tend to have high risk of bias or small sample sizes, but according to those — and apparently Michael Phelps — it’s great for pain relief.
The Zika virus has crossed the U.S. southern border and will soon be taking jobs away from American viruses. With Zika now active in the U.S., and not just from travelers abroad, the search intensifies for a vaccine to prevent the spread. A new category of therapies, DNA vaccines, appears all the rage. It’s new because no DNA vaccine has ever been approved for sale. DNA vaccine trials are currently underway by the NIH, Inovio Pharmaceuticals, and GeneOne Life Science. Still barely interested in Zika? Here’s NASA’s forecast for its spread in the U.S. Or maybe you’re not worried because you live in Europe? Well then, here’s a fun read. You’re welcome.
Remember when Theranos was making huge waves in the med device market just months ago? They’ve taken a pretty awful bludgeoning since then. In a move to regain footing, the company recently debuted a new technology, “miniLab,” at the American Association of Clinical Chemistry’s annual meeting. However, in addition to the fact that miniLab’s technology already exists, the debut was a surprise to the expert attendees who were expecting a straight-up explanation about the company’s original (and completely unrelated) blood-testing device that got CEO and founder Elizabeth Holmes banned from running a clinical testing company. It is still under fire concerning its highly inaccurate test results. Some daresay the miniLab release was a distraction from Theranos’ looming woes, but “forgive and forget” isn’t big on the scientific scene.
In creating its 2017 formulary, the pharmacy benefits manager CVS Health, said “Hit the road, Jack,” to a number of drugs. Some products like Sanofi’s insulin blockbuster Lantus and Amgen’s Neupogen were given the boot in favor of biosimilar counterparts. Ten other drugs were left high and dry for being “hyperinflationary,” including several drugs made by Valeant, Concordia, and Novum Pharma. Some rare disease and cancer drugs were also nixed. These formulary cuts should translate to cost savings for CVS Health but are worrisome for patients who may no longer have access to needed products. This is also concerning for drug makers, particularly if other PBMs follow suit.
Researchers at Johns Hopkins Bloomberg School of Public Health found that biosimilar drugs perform as well as the brand-name biologics. They analyzed data from 19 studies of biosimilars that treat rheumatoid arthritis, inflammatory bowel disease and psoriasis to reach their conclusion. Many drug innovators, on the other hand, argue that biosimilars are not equivalent to their reference products and shouldn’t be used willy-nilly as a substitute. It’s complicated so don’t expect this argument to be solved definitively any time soon (or ever?). There are currently more than 50 biosimilars in development and the Johns Hopkins study could be weighty in terms of future product adoption.
Teva has announced plans to purchase Anda, Allergan’s generics distributor. This comes on the heels of Teva having purchased roughly $40 billion worth of Allergan’s generic drugs, aka the Actavis Generics division. Anda’s reach goes beyond Actavis, however. According to the release, they distribute “generic, brand, specialty and over-the-counter pharmaceutical products from more than 300 manufacturers.” Teva projects Anda to bring in over $1 billon in third party revenue this year, and the deal is set to be completed in the second half of 2016. Hey Teva, don’t go filling up on candy or you won’t have any room for a main course of innovative pharmaceutical products…am I right? Anyone? Too much? Sorry.