“21st Century Cures” Leaves One Group With Empty Promises


Today, at 2 p.m. Eastern, the President will sign the 21st Century Cures Act—approved by the Senate on Dec. 7 by a vote of 94-to-5, overwhelmingly passed by the House the week before, and seemingly supported by every pharma company, medical institution, healthcare advocate and their mothers. And why not? “21st Century Cures” is the legislative equivalent of the Pee Wee League: In the end, there’s an award for everybody. (My colleague Sy Mukherjee has been all over the generous grab bag of provisions—here, here, and here—so I won’t go into the details now.)

But while this much-ballyhooed behemoth of a bill (nearly 1,000 pages) has been praised for being bipartisan, it’s also binomial: Technically speaking, “H.R. 34: the 21st Century Cures Act” is a “re-texted” version of “H.R. 34: the Tsunami Warning, Education, and Research Act of 2015,” which is intended to enhance and modernize the existing United States Tsunami Warning System. And the former isn’t exactly a “bill,” but rather an amendment to the latter—or, well, a House amendment to a Senate Amendment to the re-texted tsunami bill.

This procedural silliness, of course, is simply that: It’s just a little Congressional fun with words. But then, importantly, so is much of the 21st Century Cures Act.

Take, for example, the small chunk of the Act subtitled, “Supporting Young Emerging Scientists.” Here’s a very cool Permalink to take you right there.

The need to support young biomedical researchers is, frankly, an urgent one. As I’ve written about extensively in The Truth in Small Doses, it is harder than ever today for emerging scientists in the U.S. to get funding for their work, to follow independent research tracks, and to secure stable academic positions. As dismally low as success rates are for NIH grants these days, they are dramatically lower for younger scientists—and that’s slowing down science in a number of ways.

In 1980, new investigators got their first major NIH grant, on average, at age 36; today, the average age is 42. Back then, more than 40% of research project grants went to principal investigators (PIs) under 40; the share in 2016 is less than 10%. We now have more PIs age 66 and older than we do 36 and younger—and with this aging of America’s biomedical research force, we have put “a generation of science at risk.”

If all this sounds familiar, that’s because we’ve been singing this tune for a generation. In 1998, a distinguished committee led by Princeton University’s Shirley Tilghman warned that too many early-career life scientists faced diminishing and discouraging professional prospects. In 2005, another blue-ribbon committee—this one led by Nobel laureate Thomas Cech—said the situation was so dire for young American researchers that the U.S. was in danger of losing its “preeminent leadership position” in science. Three years later, another report, called ARISE, once again shouted the need to invest in early-career scientists.

All were substantive, well-researched reports that recommended substantive, well-researched fixes. So what does the 21st Century Cures bill do to implement them? It establishes the “Next Generation of Researchers Initiative” within the office of NIH Director to “promote policies and programs” that help young scientists. Gotcha.

Congrats, Congress—Collect your trophy after the game.

More news below.


Orbita has a home health tool that harnesses Amazon Echo. Orbita Healthcare, a home health solutions firm, has unveiled a new technology called the Voice Experience Designer which it hopes will assist patients adhere to their medications and keep in touch with care providers by using Amazon's Echo voice-operated digital assistant device. "We provide the connectivity services, the orchestration logic for data that comes in and collaboration app for caregivers to communicate with patients,” Orbita president Nathan Treloar told Healthcare IT News. "We want to be able to work within care plans." Orbita plans to team up with Boston's Commonwealth Care Alliance to introduce the technology into patients' homes, where they can communicate with the digital assistant (dubbed Alexa) to relay information such as blood pressure readings and get in touch with care providers about their medical questions. And the technology already works with interfaces like Google Home, and will eventually be compatible with Apple's Siri and Microsoft's Cortana, too. (Healthcare IT News)

IBM is exploring a Watson-fueled robot to help the elderly. Last week, IBM announced a collaboration with Rice University to build a prototype robot called the IBM Multi-Purpose Eldercare Robot Assistant (IBM MERA) to help elderly people and their caregivers alike. The robotic assistant would be able to collect data via sensors and detect potentially dangerous incidents like a fall. "Now is the time to invest in, care for, protect, and empower our aging population so they can live more independent lives," said Arvind Krishna, Senior Vice President at IBM Research, in a statement. "Our new research on ‘embodied cognition,’ which can combine real-time data generated by sensors with cognitive computing, will explore how to provide clinicians and caregivers with insights that could help them make better care decisions for their patients." (IBM)

Lilly is trying to lower how much people pay for its insulin—with some digital help. On the heels of rival diabetes drug maker Novo Nordisk's announcement that it will limit branded drug price hikes to the single digits going forward, U.S. pharma giant Eli Lilly announced Tuesday that it is partnering with benefits manager Express Scripts and a mobile health platform hosted by Blink Health to slash patients' insulin costs. Americans who currently have to pay the full cost of Lilly insulin (such as the uninsured and people with high deductibles) will be able to use the Blink tech to to receive discounts of up to 40%. "We understand the burden people face when paying full price for insulin," said Mike Mason, vice president of Lilly Diabetes, in a statement. "This platform will effectively allow Lilly to lower our insulin retail prices for users of this platform while not affecting the reimbursement system for other people living with diabetes." (Fortune)


Pharma is only getting a 3.7% return on R&D. The latest pharma innovation report from Deloitte holds some pretty grim news for pharma: returns on R&D investments by large cap companies slid to a mere 3.7% in 2016, down from the 10.1% returns seen in 2010 (although the cost of bringing a drug to market is beginning to stabilize). The report points to a number of factors driving big pharma companies' struggles with netting strong returns, including a dearth of late-stage pipeline candidates and diversified product portfolios that aren't necessarily spreading risk. So how can the industry reverse the trend? Deloitte points to large companies' more successful, smaller counterparts, who tend to get more bang for their R&D bucks by focusing on very specific therapeutic spaces and minimizing data complexity. (Deloitte)

Glaxo is pouring big money and resources into vaccine R&D. Pharma giant GlaxoSmithKline today opened up a massive new global vaccine center in Rockville, Maryland that will be staffed with 450 researchers and be infused with $50 million in funding over the next two years. The research center will help GSK 12 separate vaccine development programs for conditions ranging from shingles to Dengue fever. "Our investment here signifies our commitment to discovering and developing new vaccines across a range of pressing public health priorities, including those important here in the U.S," said Luc Debruyne, president of GSK Vaccines, in a statement. Glaxo recently launched a major new trial testing out an HIV vaccine in South Africa, and as Cliff has previously argued, the company's struggles to bring vaccines forward despite its commitment to the space highlights the need for a new financial model for vaccine development.

NY Governor Cuomo really wants NYC to become a biotech hub—and he's putting his money where his mouth is. Andrew Cuomo on Monday revealed a massive, $650 million plan aimed at making New York City a biotech and life sciences hub. The incentive package includes the use of tax-free lab space at New York colleges and universities, as well as grants for companies that base exciting new research in the state. "From providing the incentives to attract top talent and drive innovation, to providing the space that emerging life science companies need to grow, we are breaking down barriers and helping the industry gain momentum," said Cuomo in a statement. New York has been vying to become a biotech hotspot to rival the likes of San Francisco and Cambridge, Massachusetts, hoping to harness the numerous research facilities available in the city and its proximity to the Wall Street investment and venture capital communities. (NY Daily News)


Florida has officially been declared Zika-free. Florida got some stellar news over the weekend: The state is no longer an active local Zika transmission zone, according to the Centers for Disease Control. "There have been no new cases of local Zika virus transmission identified in South Miami Beach for more than 45 days, suggesting that the risk of Zika virus infection is no longer greater than in the rest of Miami-Dade County," the agency said in its most recent Zika update. But that doesn't mean the threat's in the rear view quite yet. Mosquito populations, including the the kind that transmit Zika, tend to die down in colder winter months but can come back with a vengeance during warmer bouts. And elsewhere in the U.S., particularly along the Gulf, the threat of locally-transmitted Zika remains real. In fact, Texas authorities are investigating a possible locally contracted case. (Fortune)


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