FHI's Week in Review - 11/11/19 - Value based care case study + JUUL's disturbing product development strategy

Volume VI, Issue 45

Nov. 11, 2019

A tiny pharmacy is identifying big problems with common drugs, including Zantac

Carolyn Y. Johnson, Science Reporter for the Washington Post delivers this interesting story on November 8, 2019.

NEW HAVEN, Conn. - The escalating global recall of Zantac, the heartburn pill that once ranked as the world's best-selling drug, has its roots not in government oversight or a high-profile lawsuit, but in a tiny online pharmacy here whose founders feared that U.S. drugs might not be as safe as people think. The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form, ranitidine, contained a chemical thought to cause cancer, more than 40 countries from Australia to Vietnam have either stopped sales, launched investigations or otherwise stepped in to protect consumers from possible health risks. In the United States, the Food and Drug Administration this month confirmed unacceptable levels of the chemical, N-nitrosodimethylamine (NDMA), in some ranitidine products.

WIM

According to the article:

"I had a fairly dim view of drug quality in the United States going into this, but we've discovered tons of problems I never even thought of - and they're all over the place," said Adam Clark-Joseph, one of Valisure's founders.

<Meanwhile> The FDA firmly rejects the idea that the drug supply is unsafe and said that one of Valisure's conclusions - that ranitidine turns into NDMA in the stomach - is not supported by the agency's testing. The agency reviews reams of data before approving a drug, inspects factories that make them, runs its own tests on selected drugs and collects reports of safety problems.

Juul Developers' Goal: 'Captivating users with the first hit'

Reuters reports via Fox Business on Nov. 5:

The San Francisco startup that invented the groundbreaking Juul e-cigarette had a central goal during its development: captivating users with the first hit. The company had concluded that consumers had largely rejected earlier e-cigarettes, former employees told Reuters, because the devices either failed to deliver enough nicotine or delivered it with a harsh taste. Developers of the Juul tackled both problems with a strategy they found scouring old tobacco-company research and patents: adding organic acids to nicotine, which allowed for a unique combination of smooth taste and a potent dose.

WIM

According to the article:

The breakthrough "nicotine salts" formula that made the Juul e-cigarette so addictive - and ignited the company's explosive market-share growth - made Juul especially attractive to teenagers and other new users who otherwise would never have smoked cigarettes, according to interviews with more than a dozen tobacco researchers, pediatricians, and a Reuters review of Juul patents and independent research on nicotine chemistry. The device delivers the drug more efficiently than a cigarette, according to emerging academic research into Juul's formula and the company's own patent documents.

Integrating Pediatric Care and Taking on Risk to Improve Health

Rebecca Gale writes in the November issue of Health Affairs:

George Datto spotted a theme in his pediatric weight management practice: The kids who had challenges in their lives such as food insecurity, poverty, and trauma weren't coming back for follow-up appointments. And without follow-up appointments or consistent treatment, the chances of achieving a healthy body weight were far lower.

"I always knew that if the bottom of the pyramid is broken, you can't start to address lifestyle. You have to address psychological and social," Datto says.

WIM

This is an excellent case study. Although pediatrics is the focus, this article has valuable applications for all providers facing the challenges of value-based care.