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AI Takes On Drug Safety

Big Blue has found yet another business application for its precocious cognitive computing system. IBM Watson Health is collaborating with the biopharmaceutical company Celgene to develop a new platform for evaluating the safety of drugs—both before and after they hit the market—the two companies are announcing this morning. The new offering, “Watson for Patient Safety,” will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too costly.

The problem is one of the toughest in drug development. Many chemical agents (and maybe even most) interact with more than one “target”—meaning that if a drug has a molecular effect to begin with, it very likely will have one or more side effects. Throw in complication No. 2: We humans, it would appear, are different from one another—meaning that if our eye color and quantity of back hair are dissimilar, we very likely metabolize and react to drugs in different ways, too. There’s more—but suffice it to say this one’s a doozy. (Here’s me going on about it at length.)

The scope of the challenge can be sized up in the FDA’s Adverse Events Reporting System. In 2014, the most recent tally available, the agency received 1,289,133 submissions of nasty drug effects—and that’s in a reporting system that’s largely…um…voluntary.

For drug makers, there’s plenty of hurt in not knowing which drugs do what to whom and when. Experimental medicines that fail in late stages of clinical testing—something that happens too often because of a toxicity or risk discovered in the eleventh hour—are incredibly costly to companies. (There’s a reason why big Phase III failures are reported in the business section of the newspaper.) Same goes for safety issues unearthed long after meds are on the market. (Can you spell “Vioxx”?)

It will be fascinating to see if IBM Watson Health and Celgene can make sense of this scientific conundrum. If it can, the result for consumers should be more, and cheaper, medicines getting on to the market. Why? Because the cost of repeated failures won’t have to be added to their price tags.

Below, more digital health news on this first day of Fortune Brainstorm Health. Make sure to catch the livestream of the event .

Clifton Leaf
@CliftonLeaf
clifton.leaf@fortune.com

DIGITAL HEALTH

Keep up with our Brainstorm Health coverage this week. As we hope you know by now, Fortune's inaugural Brainstorm Health conference commences this afternoon in San Diego. I encourage you to follow our livestream of the event, which will feature a who's-who of expert speakers and panelists discussing the most fascinating and groundbreaking issues in digital health, pharma, biotech, healthcare policy, and more with senior Fortune staff and other luminaries in the field. A team of Fortune reporters (myself among them) will also be diligently covering the sessions over these next two days, and it goes without saying that we'll hit all the highlights on both Fortune.com and our upcoming Brainstorm Health Daily newsletters. Stay tuned.

Senators want to beef up telemedicine in government programs. A group of U.S. Senators is getting credit for something that might seem inconceivable in the contentious political climate leading up to next week's presidential election: Proposing significant healthcare reforms that could potentially be a major benefit for Americans with chronic medical conditions who use government health programs. The American Telemedicine Association praised Senate Finance Committee Members for their ongoing work on the CONNECT for Health Act, which (in part) aims to expand Medicare and Accountable Care Organization (ACO) coverage for telehealth technology that's used to remotely diagnose strokes. "We foresee that this bill will greatly improve the Medicare experience and provide needed evidence for telehealth for subsequent improvements," said American Telemedicine Association CEO Jonathan Linkous in a statement.

Former NSA agent dishes on how the health industry can protect data. It's no secret that the healthcare sector hasn't exactly been doing a bang up job when it comes to cybersecurity. And who better to give the industry some advice than a man who had to deal with regular cyber onslaughts as part of his career with the National Security Agency? Former intelligence official and current Center for Internet Security senior vice president Tony Sager tells Healthcare IT News what he thinks health organizations need to do in order to address the digital elephant in the room. "First, figure out what to do in this noisy environment; second, actually do it, which means get a budget, convince your boss, scour the marketplace and buy things; and third, explain what you have done to other parties over and over again, to regulators, auditors, supply chain partners and so on." (Healthcare IT News)

A Zika-fighting mobile app IDs mosquito breeding grounds. The fight against Zika virus is going high-tech with a new app that helps health officials track down the problematic mosquitoes that spread the pathogen, which has been linked with potentially devastating birth defects in the children of pregnant women who contract it. The app was developed by Texas A&M University researchers and allows users to crowdsource information about where, exactly, Zika propagators reside and breed so that they can be targeted for elimination. (Modern Healthcare)

INDICATIONS

Key players are starting to worry about the drug price backlash. You may have heard that the American public and lawmakers on both sides of the aisle aren't particularly enamored with biopharma companies' exorbitant price hikes on generic and branded medications alike. But major industry firms like Cardinal Health, McKesson, and others are now openly sounding the alarm bells on pricing. These companies, which serve as the middlemen between pharma and consumers through distribution, say that a combination of lower branded medication prices and smaller generic drug price hikes will be bad for their businesses. The question is: how much sympathy will they get from the political class and a clearly frustrated public? (Wall Street Journal)

A biotech hub in New York? A powerhouse trio wants to make it happen. Memorial Sloan Kettering Cancer Center, Rockefeller University, and Weill Cornell Medicine are teaming up with Japan's Takeda Pharmaceuticals (which is on a significant restructuring binge, especially in the U.S.), Bay City Capital, and Deerfield Management to form Bridge Medicines—the next step of a formidable biotech center in New York City. This is a natural slew of players for this exact mission, since the combination of financial and intellectual heft involved has the ability to carry promising preclinical assets from the lab across the regulatory finish line. The hope? Setting up a challenger to the Massachusetts and California-based biopharma hubs that are largely associated with the field.  (FortuneEndpoints)

THE BIG PICTURE

Obamacare enrollment period launches today. Amidst significant controversy and a whole lot of confused political commentary, the open enrollment period for individual insurance plans under the Affordable Care Act begins today (and will continue through the end of January 2017). The health law has certainly faced many legitimate challenges that will need to be addressed over this past year, including a sicker (and more expensive) enrollment pool than insurers originally expected, which has led to significant premium increases in the marketplaces and insurer flight from the exchanges. Still, the topline doom and gloom commentary has neglected the fact that many of the current problems could, at least to some extent, be addressed with legislative fixes such as stronger subsidies that would help the relatively small slice of consumers who don't qualify for financial assistance under the law. But that's assuming that members of Congress can actually get together to strike a deal on a controversial policy that's become something of a political litmus test.

2 billion children are exposed to poisonous air every day. A new UNICEF report finds that two billion children come into contact with toxic air every day—and it consequently leads to more than 500,000 deaths per year. While South Asia and Africa are singled out for having a disproportionate number of affected kids, the global health experts behind the research warn that it's a big issue for children in more developed areas like Europe and North America, too. (Huffington Post)

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