The Fallout from Novartis’ Alleged Data Manipulation: Brainstorm Health
Hello and happy hump day, readers.
The fallout from allegations of data manipulation continues at drug giant Novartis, with the company reportedly axing brother scientists who held high-level posts at its subsidiary AveXis, which is at the heart of the controversy.
In a statement, Novartis said that Brian Kaspar and Allan Kaspar – the previous chief scientific officer and R&D VP at AveXis, respectively – “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company.” It’s unclear exactly why the pair were let go, but the timing of the departures syncs with the approval of Zolgensma in May.
Zolgensma is a gene therapy for the deadly rare disease spinal muscular atrophy (SMA) and comes with a $2.1 million list price, making it the most expensive drug in the world (at least on paper). Last week, the Food and Drug Administration (FDA) alleged that, “following the FDA’s approval of the product, the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA.”
While the agency didn’t say Zolgensma should be taken off the market because of the issues – a fact that Novartis has emphasized in its response to the allegations – it did bring up the specter of potential civil or criminal action against the firm over the alleged data manipulation.
Novartis CEO Vas Narasimhan said in a conference call last week that the company began investigating the issues immediately after hearing about them, and that the relevant employees would be “exiting” the firm. The timeline of how this entire episode went down, however, remains murky – and Congressional lawmakers of both parties have already expressed their displeasure.
Read on for the day’s news.
Can virtual reality help treat pain? A new study from Cedars-Sinai finds that virtual reality therapy can be an effective way to treat all sorts of pain for patients receiving treatment inside a hospital - especially if the therapy is conducted over the course of several days. The patients in the study were given Samsung Gear Oculus headsets (along with a Samsung smartphone) which displayed "health and wellness" content and advised to use the sets three times per day in 10-minute sessions. (MobiHealthNews)
FDA approves a new drug to treat TB. The Food and Drug Administration (FDA) has approved a new therapy for treatment-resistant tuberculosis, according to TB Alliance, the nonprofit firm which developed the drug. What makes the medicine - which will be manufactured and distributed by Mylan and is part of a three-drug cocktail - unique is that it has a six-month dosing regimen as opposed to the two years it can take to treat highly-resistant TB. (Reuters)
Will MDMA become an approved PTSD treatment? NPR reports on the progress that MDMA, commonly known as the main ingredient in the party drug ecstasy, has made as a clinical treatment for post-traumatic stress disorder (PTSD). The drug is currently in phase 3 trials for the disorder, and the studies have posted some remarkable results. (NPR)
THE BIG PICTURE
UnitedHealth report points the finger at hospitals for rising costs. Welcome to another edition of the "health care cost blame game." This time, though, the alleged villain is one that's not mentioned all that often. Insurers and drug companies take a regular beating from lawmakers - but UnitedHealth Group's new report points the finger at soaring hospital prices. "UnitedHealth said inpatient prices rose 4.5% annually from 2013 through 2017 — even though insured consumers' use of inpatient care dropped 5%," reports Healthcare Dive. (Healthcare Dive)
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