Welcome to Brainstorm Health Daily

There is no more romantic notion of medical discovery, perhaps, than that of Alexander Fleming returning from vacation to his messy London laboratory in the summer of 1928. Fleming, as the story goes, noticed a mold-spotted Petri dish tucked in the corner of his workbench—a lucky observation that, through keen deduction and experiment, led the Scottish bacteriologist to find penicillin, the greatest wonder drug the world has ever known.

Penicillin changed the course of human history. Many would argue its advent marks the true start of 20^th century medicine—the first “definitive moment of the modern therapeutic revolution,” as historian James Le Fanu has written. And yet, Fleming’s discovery wasn’t revolutionary in the least. In fact, in short order, it was all but forgotten.

Until a decade later, that is—when an Oxford pathologist named Howard Florey was rifling through back issues of The British Journal of Experimental Pathology and alit upon Fleming’s report. Florey and colleagues Ernst Chain, Norman Heatley, and others, purified the bacteria-killing chemical in Fleming’s mysterious mold, did their best to enrich it, and tested it on human patients. But the transformational moment didn’t arrive until 1941. That was when Florey and Heatley journeyed across the Atlantic to enlist several U.S. Drug makers into figuring out how to make heaps of the stuff—which the companies succeeded in doing. That’s when the revolution happened.

In a matter of five years, amid the fury of a global war, writes Roswell Quinn, this diverse group went from “growing crude penicillin in bedpans and milk bottles to fermentation of highly refined penicillin in 10,000-gallon tanks. In this short time, a little-known, clinically insignificant, and unmanageable compound became a mass-produced miracle.”

Today, we are in the midst of another technology-driven—and dare we say, company-driven—transformation in medicine. Call it the digital health revolution—or heck, if we can be a little grandiose here, the moment when 21^st century medicine begins. Near-simultaneous advances across an enormous spectrum of new tech—deep learning, big-data analytics, wearable sensors, hyperconnectivity, 3D printing, gene editing, virtual reality, and much more—are suddenly, and rapidly, shaking up a sector that now accounts for $3 trillion of spending every year in the U.S. That works out to nearly $10,000 per person.

Technology is changing virtually every aspect of the healthcare continuum—from how we detect and diagnose disease, to how and where we deliver care, to the notion of what it means to be well in the first place. It’s changing medical research, the way we calculate risk, and how we pay for healthcare. And some day—if this particular slice of the economy follows the pattern set by every other sector that has been disrupted by technology—all that care will cost less. Which is a good thing. (See the $10,000-a-year billing statement waiting for you at the cashier.)

Our mission with Coins2Day Brainstorm Health Daily is to chronicle this transformation. We’ll do our best to provide news, analysis, and hopefully, some insight about this ongoing upheaval and the pitchfork brigade of companies that are leading it. My colleague, Coins2Day writer Sy Mukherjee, who was previously the editor of industry publication and newsletter BioPharma Dive, will do much of the reporting and sleuthing (see below). And each day, I’ll take a stab at framing one big idea or trend, or profiling one change agent or another. We’re counting on you—our expert readers—to offer us leads, suggestions, comments, and corrections, so please feel free to email.

In the meantime, welcome to the revolution.

Clifton Leaf

@CliftonLeaf

[email protected]

INDICATIONS

Merck's Keytruda nabs a key approval in advanced lung cancer. Merck got a welcome October surprise when the Food and Drug Administration (FDA) gave its next-gen cancer drug Keytruda an earlier-than-expected approval for use in previously untreated non-small cell lung cancer (NSCLC) on Monday. Merck has been duking it out with rival Bristol-Myers Squibb, whose own immunotherapy, Opdivo, has been lapping Keytruda in sales. But Bristol-Myers shares slumped earlier this month on disappointing Opdivo data showing that standard chemotherapy was more effective in advanced lung cancer patients. Keytruda, meanwhile, has demonstrated a survival benefit. (Reuters)

GlaxoSmithKline files for a potential blockbuster shingles vax. On Monday, Glaxo filed its experimental shingles vaccine Shingrix for FDA clearance, setting up what could become the first major approval of incoming CEO Emma Walmsley's tenure as chief executive. The vax has shown solid results in clinical trials and that could give it a big leg up on Merck's rival Zostavax, potentially bringing GSK $1 billion per year in sales if Shingrix crosses the regulatory finish line. (Coins2Day)

John Oliver made a glaring omission in his anti-pharma rant. Few comedians deliver searing political commentary like John Oliver. On Sunday, during his HBO show Last Week Tonight, Oliver focused his outrage on the pharmaceutical and health care industries for their roles in perpetuating the American opioid painkiller addiction and overdose epidemic. But what Oliver didn't mention is that the very sector that helped let the genie out of the bottle with its aggressive marketing is also trying to get it back in through innovative new ways to treat addiction, shifting insurance models that encourage recovery and alternative therapies, and research into non-opioid painkillers. (Coins2Day)

Inovio slumps on FDA hold for HPV cancer drug. There's nothing quite like an FDA clinical hold to send investors scurrying, and Inovio shareholders are doing just that in the wake of a regulatory hold for its experimental drug VGX-3100, meant to prevent HPV-related cancers. (FierceBiotech)

DIGITAL HEALTH

This new nanotech could become the next major cancer breakthrough. Researchers have created synthetic nanoparticles that can seek out a different kind of target to stop the spread of cancer: structures called neutrophil extracellular traps (NETs) that are meant to help fight bacteria but can have the unintended effect of allowing cancers to exploit the small holes they create in tissue. So far, the tech has only been used in mouse models, but it showed promise in stopping the spread of breast cancer. (Coins2Day)

FDA launches a whistleblower site for "regulatory misconduct." The Food and Drug Administration is responding to criticism about how it deals with adverse event reports from medical device makers by opening up a new "Allegations of Regulatory Misconduct" form. The agency was accused by the Minneapolis Star Tribune of allowing firms to file retrospective reports of adverse events, meaning the public would often have no knowledge of the reported issues. (Mass Device)

New gadgets claim to help you sleep soundly. U.S. Public health officials say that one in three people don't get enough sleep. But could a high-tech mattress or a "smart" sleep mask help reverse that trend? Here are some high-tech solutions to a restless night. (Coins2Day)

THE BIG PICTURE

Obamacare premiums are set to soar next year. The Affordable Care Act, aka Obamacare, has been making waves all year long, and not in a good way. President Obama's signature domestic achievement got another slice of bad news on Monday when the Obama administration announced that premiums for the key "benchmark" plans sold on Healthcare.gov will rise an average of 25% in 2017. But the issue is more complicated than that, since an accompanying rise in subsidies will shield many plan holders from the hikes, and the individual insurance market affects just a sliver of Americans. Still, President Obama himself has recently admitted the need for tweaks to the law in order to make it function better. (Coins2Day)

Ebola nurse Nina Pham settles suit with Dallas hospital. Nina Pham, who became on of the first Americans to contract Ebola from a patient at the Dallas hospital where she worked, has settled a lawsuit with Texas Health Resources over what she said were lackluster and ineffective protocols for protecting nurses during the outbreak in 2014. Pham recovered from Ebola under the care of the National Institutes of Health (NIH). The parties have declined to divulge the settlement details. (Coins2Day)

Catholic Health Initiatives and Dignity Health mull a merger. A potential M&A between Catholic Health Initiatives and Dignity Health would create one of the largest nonprofit health networks by revenue, according to the Wall Street Journal, which reports that such a deal would combine a total of 142 hospitals and bring in combined revenue of $27.8 billion per year. (Wall Street Journal)

FDA approval changes could impact drug prices. The Food and Drug Administration is contemplating regulatory changes that could help boost the number of generic drugs on the market and put some downward pressure on soaring drug prices. The possible shifts involve the FDA's generic drug user fee program, which has been around since 2013, and an expedited review process for drugs that could have a major impact on public health. (Commonwealth Fund)