The Vaping-Linked Lung Disease Outbreak Is Getting Serious…

Happy Friday, readers!

The surge in lung disease cases, and at least five deaths, seemingly linked to vaping products is serious enough that some public health officials are cautioning consumers to avoid such products until there’s more information on the root cause.

Newly reported fatalities in Indiana, California, and Minnesota have brought the reported death toll up to five, and more than 400 people have gotten sick.

Experts are still cautioning that this mysterious outbreak isn’t necessarily tied to a single manufacturer, product, or even substance (such as the marijuana compound THC or just plain nicotine). However, the CDC’s Dana Meaney-Delman said in a conference call that “people should consider not using e-cigarette products” while the investigation into the matter continues.

Others, including former FDA commissioner Scott Gottlieb, have pointed to (very) early data suggesting that a Vitamin E derivative used in these products may be linked to this outbreak.

And there’s the rub. Vaping technology is still, relatively, in its infancy. It will take years, and perhaps even decades, to fully understand its effect on the human body.

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee, @the_sy_guy, [email protected]

DIGITAL HEALTH

FDA head warns against data manipulation in drug development. Acting Food and Drug Administration (FDA) commissioner Ned Sharpless is throwing some shade at drug makers that may feel inclined to manipulate data in order to game the system (and the comments appear to refer to some recent events along these lines). "So it should not be surprising to me now at FDA that if people will lie to get their paper published or get their grant funded, then people will also lie to get a billion dollar medical product approved," said Sharpless in an address to the Research!America 2019 National Health Research Forum. We simply cannot tolerate deception of any kind. Now, I do not wish to imply this problem is rampant, or even that it is increasing in frequency (in fact we have no evidence of that)," he continued. "But we do see data fraud at FDA, and more than I would have expected prior to coming to the agency."

INDICATIONS

Roivant reaches $3 billion deal, but will investors benefit? Roivant Sciences has a charismatic leader in Vivek Ramaswamy, who's been able to pull off multiple IPOs for the federation of firms under the Roivant umbrella (and, previously, pulled in veteran biopharma talent to join his cause before a number of departures). Now, Roivant has struck a $3 billion deal with Japan's Sumitomo Dainippon Pharma, which will buy stakes in five of the "Vant" umbrella corporations (several of those companies are public). One outstanding question: How will smaller investors fare under this deal? (FierceBiotech)

Novo to release generic version of its own insulin. Novo Nordisk is taking a page from numerous other drug makers and proactively cutting its own insulin prices. Eli Lilly and France's Sanofi have made similar moves in the face of public and Congressional scrutiny over insulin prices. Novo will now slash the list price of its diabetes treatment Novolog by 50%. (Reuters)

THE BIG PICTURE

Study: Race may affect where ambulances take patients. A new study published in JAMA finds that race may play a role in where certain patients are taken in ambulances. The thing is, it's hard to understand exactly what drives these discrepancies. You can read the study here. (ModernHealthcare)